Note: Descriptions are shown in the official language in which they were submitted.
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TENSIONED INFUSION SYSTEMS WITH REMOVABLE HUBS
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a) a continuation of U.S. Application No. 17/838,027,
filed June 10,
2022, and b) claims priority to U.S. Provisional Application No. 63/211,359,
filed June 16, 2021,
which are hereby incorporated by reference in their entirety. This application
is also related to
U.S. National Phase Application No. 17/784,328, filed U.S. December 10, 2020,
U.S.
Provisional Application No. 62//946,345, filed December 10, 2019, Pat. No.
8,592,640, U.S. Pat.
No. 9,248,048, U.S. Pat. No. 9,844,470, and U.S. Pat. No. 11,013,638, which
are hereby
incorporated by reference in their entirety.
BACKGROUND
Scar formation in response to cutaneous injury is part of the natural wound
healing
process. Wound healing is a lengthy and continuous process, although it is
typically recognized
as occurring in stages. The process begins immediately after injury, with an
inflammatory stage.
During this stage, which typically lasts from two days to one week (depending
on the wound),
damaged tissues and foreign matter are removed from the wound. The
proliferative stage occurs
at a time after the inflammatory stage and is characterized by fibroblast
proliferation and
collagen and proteoglycan production. It is during the proliferative stage
that the extracellular
matrix is synthesized in order to provide structural integrity to the wound.
The proliferative
stage usually lasts about four days to several weeks, depending on the nature
of the wound, and it
is during this stage when hypertrophic scars usually form. The last stage is
called the remodeling
stage. During the remodeling stage, the previously constructed and randomly
organized matrix
is remodeled into an organized structure that is highly cross-linked and
aligned to increase
mechanical strength.
While the histological features characterizing hypertrophic scars have been
well
documented, the underlying pathophysiology is not well known. Hypertrophic
scars are a side
effect of excessive wound healing, and generally result in the overproduction
of cells, collagen,
and proteoglycans. Typically, these scars are raised and are characterized by
the random
distribution of tissue bundles. The appearance (i.e., size, shape, and color)
of these scars varies
depending on the part of the body in which they form, and the underlying
ethnicity of the person
affected. Hypertrophic scars are very common, and may occur following any full
thickness
injury to the skin. Recently, it has been shown in U.S. Patent Application
Publication
2006/0037091 (U.S. Patent Application Serial No. 11/135,992 entitled "Method
for Producing
Hypertrophic Scarring Animal Model for Identification of Agents for Prevention
and Treatment
of Human Hypertrophic Scarring," filed May 24, 2005) which is hereby
incorporated by
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reference in its entirety, that mechanical stress may increase hypertrophic
scarring in a murine
model.
Keloids are typically characterized as tumors consisting of highly
hyperplastic masses that
occur in the dermis and adjacent subcutaneous tissue in susceptible
individuals, most commonly
following trauma. Keloids are often more severe than hypertrophic scars, since
they tend to
invade normal adjacent tissue, while hypertrophic scars tend to remain
confined within the
original scar border.
Scar tissue may also be formed from repetitive tissue injuries, such as
patients who require
repeated needle insertions for blood draws or injections or infusions of
therapeutic agents for
treatment of chronic health issues, including but not limited growth hormone
injection,
autoimmune diseases such rheumatoid arthritis, and diabetes, and also from
other therapeutic or
diagnostic procedures or devices that may utilize an indwelling catheter or
needle.
BRIEF SUMMARY
Devices, kits and methods described herein may be for treatment of a subject
at a skin site
including without limitation for wound treatment or the treatment,
amelioration, or prevention of
scars and/or keloids, by manipulating mechanical or physical properties of
skin or by shielding
skin from stresses, and/or by controllably stressing or straining the
epidermis and layers of
dermal tissue at or near a skin site, i.e., at or adjacent a wound or a
treatment site of a subject's
skin.
Some tissue responses and diseases, however, are associated with tissues below
the dermal
layer of the skin. The subcutaneous region, or hypodermis, is the deepest
layer in the skin and
varies in depth from the epidermis. Skin thickness averages between 1.5 mm and
2.7 mm at
various body sites, and has a different density and elasticity compared to the
subcutaneous tissue
below it. While dermal tissues are developmentally derived from endoderm and
comprises
collagen and other connective tissue having higher tensile strength, the
hypodermis is
developmentally derived from mesoderm and comprises loose areolar connective
tissue. For
these reasons, it is unclear whether planar load forces acting on the
epidermis will transmit
through the dermis and to the hypodermis or other anatomical structures below
the epidermis.
Nevertheless, it is hypothesized herein that the mechanical interplay between
the
epidermis/dermis and the subcutaneous tissue may have some mechanobiologic
effect on
subcutaneous tissues and structures.
Also, the impact of scar tissue formation are not limited to cosmetic effects.
For example,
diabetes patients may develop scar tissue and/or lipohypertrophy at chronic
injections sites.
Lipohypertrophy is an increased formation of fat tissue that is thought to be
a hypertrophic effect
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from chronic localized insulin injections on adipose cells. The
lipohypertrophy can adversely
affect insulin injection or infusion rates due to structural changes in the
tissue that can decrease
the diffusion of insulin. Typical infusion using insulin pumps involves the
placement of a
cannula or needle into the delivery site (e.g., abdomen, arms, buttocks,
thighs) every few days.
Over time, this can induce lipodystrophic changes in the skin and subcutaneous
structure, which
can result in unpredictable or erratic insulin absorption. Eventually the
patient may be limited in
the available infusion sites on their body due to lipohypertrophy. Although,
the effects of
lipohypertrophy and lipodystrophy are thought to be induced by the insulin
itself, it is
hypothesized that tension offloading of the infusion location may also reduce
this insulin effect,
and may improve the variability and/or overall absorption rates at the
infusion site. This may
occur by reducing the formation of fibrosis, improving the vascularization,
and/or reducing
vascular resistance to perfusing the tissue under or about the insertion site.
In some variations, it
is hypothesized that the change in skin tension and/or the increased adhesive
properties of the
tensioned dressing or dressing component may extend the usable duration of the
infusion set or
sensor, e.g. from 2-3 days to 4 to 7 days. This may also result in a reduction
of the size, surface
area, depth and/or severity of inflammation at the injection/infusion site(s).
It is also believed that treatment of the injection and/or infusion sites of
diabetes therapy
may also have other effects separate from affecting the development of scar
tissue or
lipohypertrophy. For example, treatment of an injection site and/or injection
at a site that has
already been treated with a skin tensioning device may improve the dispersion
of insulin at the
injection site by altering the mechanical environment. For example, insulin
leakage at the
injection or infusion site may be reduced because of increased mechanical
pressure at the skin
surface, which may drive injected therapy deeper into the tissue because of
the pressure gradient
generated in the tissue by the tensioning device. This and other mechanical
effects of skin
tension treatment may result in an increased insulin bolus volume and/or
surface area per unit
injection. The mecha.nomodulation effects may results in improved insulin
absorption, with a
reduced average total daily, weekly and/or monthly insulin dosage, and/or
improved daily,
weekly and/or monthly time-in-range of blood glucose, with a reduced frequency
or degree of
hyperglycemia. The tensioning device may also reduce pain at the injection
site, as a result of
mechanomodulation of the nociceptors, and/or may reduce the risk of infection
and/or pump
alarms from occlusion, as a result of mechanically stabilizing the tissue.
The therapies described herein are not limited to treatment of the sequelae of
diabetes or
diabetes treatment, but may also be applied to other disease states involving
injectable therapies
or subcutaneous lesions or disease states, or even intramuscular injections.
It is hypothesized that
general changes in drug absorption or diffusion in the subcutaneous layer
subcutaneous layer, or
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relative changes in vascular flow between the dermis and subcutaneous tissue,
reduced tissue
inflammation in the dermis and/or hypodermis, and/or the prevention or
reduction in the
development of subcutaneous tissue lesions, may be achieved. This may include
treatment or
prevention of other lipodystrophies, both acquired and genetic. The therapies
described herein
may be used for continuous, one-time or intermittent treatment of chronic
injection, infusion, or
implantation sites, or temporary or intermittent treatment. This may include,
for example,
treatment of sites for indwelling insulin pumps, indwelling or implanted
continuous glucose
monitoring sensors, chronic injection of autoimmune or oncology therapies,
hemodialysis, joint
or sleep apnea implants, neurostimulator electrodes, contraceptive implants,
and the like.
In one embodiment, an integrated infusion set is provided, comprising an
infusion
assembly attached to an upper surface of the tension dressing layer, wherein
the infusion
assembly comprises an infusion conduit configured for insertion into a
treatment location, and a
releasable attachment structure attaching the infusion hub to an upper surface
of the tensioned
dressing layer; a pre-strained dressing, the pre-strained dressing comprising
a tensioned dressing
layer, a skin adhesive on a lower surface of the tension dressing layer, one
or more adhesive
protective liners removably covering the skin adhesive, and a tension support
structure
configured to maintain the tension dressing layer in a stressed configuration,
the tension support
structure comprising one or more pull tabs. The infusion assembly may further
comprise an
infusion housing attachable to the infusion hub, the infusion housing
comprising tubing in fluid
communication with a cavity of the infusion housing, wherein the cavity is
configured to receive
the infusion hub and to provide fluid communication between the tubing and the
infusion
conduit. The infusion conduit may be an infusion needle or infusion catheter.
The infusion set
may further comprise an infusion set applicator releasably attachable to the
infusion hub and
further comprising a needle configured to removably extend through the
infusion hub and out of
a distal end of the infusion conduit. The releasable attachment structure may
comprise a
removable section to which the infusion hub is attached. The releasable
attachment structure
may comprise two or more non-removable sections coupled to the removable
section. The two
or more non-removable sections coupled to the removable section may be coupled
via a tear or
frangible structure. The tear structure may comprise a plurality of
perforations. The frangible
structure may comprise a frangible strut The removable section may comprise a
pull tab or
handle. The non-removable section may comprise a split ring or plurality of
arcuate bodies
attached to the tensioned dressing layer. The non-removable sections may
comprise slots
configured to movably receive tabs located on the removable section. The
removable section
may be integrally formed with the infusion hub. The slots may be arcuate
slots. The infusion
hub may further comprise a hub body and a hub base, and wherein the hub body
is releasably
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attachable to the hub base, and the hub base is attached to the tensioned
dressing layer. The hub
body may comprise a releasable latch. The infusion set may further comprise a
removal tool, the
removal tool configured to actuate the releasable latch of the hub body and to
facilitate
separation of the hub body from the hub base. The hub base may comprise a
softer material than
the hub body. The removal tool may comprise prongs with tabs, wherein the
prongs are
configured to actuate the releasable latch of the hub body, and the tabs of
the prongs are
configured to lock to the hub body. The hub body may comprise access channels
to the release
latch which configured to receive the prongs with tabs. The infusion housing
may comprise a
release latch configured to unlock the infusion housing from the infusion hub.
In another embodiment, a method treating a treatment site is provided,
comprising
removing a first infusion housing from an infusion hub attached to a treatment
site via a
tensioned dressing, and separating at least some the infusion hub from the
tensioned dressing
while leaving the tensioned dressing attached to the treatment site. The
method may further
comprise inserting a cannula of the infusion hub into the treatment site, and
adhering the
tensioned dressing around the treatment site. Inserting the cannula may be
performed with an
applicator coupled to the infusion hub. The cannula of the infusion hub may
comprise inserting
the cannula of the infusion hub concurrently with a needle of the applicator
into the treatment
site. The method may further comprise decoupling the applicator from the
infusion hub after
inserting the cannula of the infusion hub. Decoupling the applicator form the
infusion hub may
also cause withdrawal of the needle from the cannula of the infusion hub. The
method may
further comprise attaching an infusion housing to the infusion hub, and
infusing therapy through
a tubing of the infusion housing and through the cannula of the infusion hub.
The method may
further comprise leaving the tensioned dressing on the treatment site for at
least 12, 24 or 48
hours after separating the infusion hub. The method may further comprise
separating an infusion
housing from the infusion hub prior to separating the infusion hub from the
tensioned dressing.
Separating the infusion hub from the tensioned dressing may comprise inserting
a removal tool
into an infusion body of the infusion hub, and pulling away the infusion body
from an infusion
base of the infusion hub. Separating at least some the infusion hub from the
tensioned dressing
may comprise separating all of the infusion hub from the tensioned dressing.
Separating at least
some the infusion hub from the tensioned dressing may comprise pulling a tab
of an attachment
structure attaching the infusion hub to the tensioned dressing, and tearing
the attachment
structure along perforations to separate the infusion hub from the tensioned
dressing and a non-
removable portion of the attachment structure. Separating at least some the
infusion hub from the
tensioned dressing may comprise breaking off the infusion hub from the
tensioned dressing.
Breaking of the infusion hub from the tensioned dressing may comprise breaking
off frangible
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struts of an attachment structure attached to the tensioned dressing and to
the infusion hub.
Separating at least some the infusion hub from the tensioned dressing may
comprise rotating the
infusion hub from attachment slots of an attachment structure. Separating at
least some the
infusion hub from the tensioned dressing may comprise rotating the infusion
hub from a helical
interface of an attachment structure.
According to variations, manipulating mechanical or physical properties may
thereby
modulate tensile or compressive stress at the skin site. The stress at the
skin site may be reduced
to levels below that experienced by normal skin and tissue. The stress at the
skin site may be
increased to levels above that experienced by normal skin and tissue. The
stress or strain may be
applied to sun-ounding tissue in one, two, or more directions to manipulate
endogenous or
exogenous stress at the skin site in one, two or more directions. According to
variations, devices
and methods described herein may reduce or otherwise manipulate the stress
experienced by skin
and/or a wound and surrounding tissues in order to treat a subject The devices
may also assist
in preventing or reducing the incidence of wound dehiscence.
According to the devices, kits and methods described herein, a skin treatment
device, skin
device, wound treatment device, scar or keloid treatment device, scar or
keloid amelioration or
prevention device, bandage, or dressing may be provided that may be applied,
attached to or
coupled to one or more layers of the skin or tissue of a subject (hereinafter
referred to as
"dressing", "skin device" or "skin treatment device").
In addition to amelioration of scar formation, other uses for such skin
treatment device
may or may not include without limitation, for example, treating skin related
conditions such as
acne, blemishes, rosacea, warts, rashes (including but not limited to
erythematous, macular,
papular and/or bullous conditions), psoriasis, skin irritation/sensitivity,
allodynia, telangiectasia,
port wine stains and other arterio-venous malformations, and ectopic
dermatitis; treating or
improving existing scars, wrinkles, stretch marks, loose or sagging skin or
other skin
irregularities; lifting, pinning, holding, moving skin for various purposes
such as during pre-
operative preparation, during surgical procedures for example as a low-profile
tissue retractor, to
stabilize blood vessels during needle or catheter insertion, postoperatively,
pre or post
operatively for pre-treating or preconditioning skin for example, prior to
scar revision, wound
incision, body contouring, in mastectomy skin expansion, aesthetic skin
treatment or resurfacing
whether topical or subdermal, whether or not using an energy modality such as,
for example,
microwave, radio-frequency ablation, high-intensity focused ultrasound, laser,
Infrared,
incoherent light, during weight loss, or for aesthetic purposes; hair removal
or hair loss; treating
and/or closing skin injuries for example, incisions, wounds, chronic wounds,
bed sores, ulcers
(including venous stasis ulcers), preventing or reducing the incidence of
wound dehiscence,
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diabetic skin or wound conditions, burn healing and/or relief; acting as an
occlusive or negative-
pressure wound dressing; protecting incisions or wounds, e.g. prevention of
splitting or opening,
protecting newborn belly buttons after cutting umbilical cord. Such treatments
may include use
of a drug or other therapeutic agent that may be applied to the skin with such
device. The agents
may include but are not limited to antibiotics, anti-fungals, immune
modulators including
corticosteroids and non-steroidal immune modulators. The agents may be
provided in any of a
variety of formulations, including but not limited powders, gels, lotions,
creams, pastes,
suspensions, etc. The devices may also be used for purposes of delivering a
drug to the skin or
through the skin, for example by stretching the skin and applying a drug
thereto. Different
configurations of the device may be amenable to the size or geometry of
different body regions.
The treatments may be applied to regions of any shape (e.g. linear, curved,
stellate), size or
depth, and to one or more regions of the body, including but not limited to
the scalp, forehead,
face (e.g. nose, eyelid, cheeks, lips, chin), ears, neck, shoulder, upper arm,
lower arm, palm,
dorsum of the hand, fingers, nailbed, axilla, chest, nipple, areola, back,
abdomen, inguinal
region, buttocks, perineal region, labia, penis, scrotum, thigh, lower leg,
plantar surface of the
foot, dorsal surface of the foot, and/or toes. Such devices may also be
referred to herein as a
"dressing", "skin device" or -skin treatment device".
In some situations, an immediate, quick or simple application of a dressing
may be
desired. Devices, kits and methods described herein may be for the preparation
and/or
application of a dressing to the skin and the separation of the applicator,
tensioning device or
dressing carrier, support or base from the skin device.
The devices, kits or methods described herein may include a packaging,
carrier, support,
base, applicator or tensioning device, each of which may: contain, hold, carry
or support a
dressing at least temporarily; may be used to prepare a dressing for
application; may be used to
deliver, orient or apply a dressing; may be used to maintain a dressing in a
stressed or strained
configuration; may be used to stress or strain a dressing; may be used to
separate the dressing
from the packaging, carrier, support, base, applicator or tensioning device
and/or may be used
during or after application of a dressing to provide additional treatment to a
wound, incision or
other treatment location; and/or may be used to apply pressure to a wound,
incision or other
treatment location. According to some variations, a packaging and/or
applicator may provide
structural support for a dressing while or after an adhesive liner is
released. According to some
variations, the assembly may be constructed to avoid folding or bending of the
dressing to the
extent that the adhesive on the dressing sticks to itself For example, when
some variations of
the dressing are held or supported at one point or along one edge of the
dressing in a cantilever
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configuration, the dressings will not bow, laterally deform, or otherwise
deform out of plane,
under their own mass or configuration.
In some other variations of the devices and methods herein, a device with a
substantially
rigid support structure or that provides structural support to a dressing and
that provides a
particular resistance to bending or column strength when two opposing edges of
the device and
support structure are placed under a compressive load that causes axial
compression or lateral
deformation, e.g. a force similar to a hand grasping force is applied to an
edge of the device,
before the device buckles or folds. For example, a resistance to bending may
be characterized as
the peak force that is achieve as the device and support structure are
compressed without
compressed by 25% of its original dimension. This column strength or rigidity
may vary,
depending upon the direction along the device and support structure being
measured. In some
further variations, the peak force may be at least about 0.02 Newtons per
millimeter (N/mm),
about 0.03 N/mm, about 0.05 N/mm, about 0.1 N/mm, about 0.15 N/mm, about 0.2
N/mm, about
0.3 N/mm, about 0.4 N/mm or about 0.5N/mm. In some variations of devices
comprising
generally flat or planar devices and support structures having a thickness,
the peak force may be
measured by applying a compressive force along the shortest dimension of the
device/support
structure that is transverse to the thickness of the device/support structure.
According to such
variations, the device may have an aspect ratio of length to width that is
greater than 1:1, 2:1 or
3:1, for example.
A resistance to bending in the direction of dressing strain may also be
measured by three-
point bending, applying a transverse force to the midpoint of the applicator
simply supported on
two outer points at a given distance apart or support span. For example, the
distance between the
two points of a sample may be approximately .75 inches and a force that ranges
from about 1 to
1.25 pounds may be applied to a sample approximately .35 inches in width
resulting in a
deflection of approximately 0.05 inches. A resistance to bending may also be
measured by
characterizing the force at which buckling occurs on a simply supported beam.
For example, a
force of approximately .45 pounds may be applied to a simply supported sample
approximately
.35 inches in width and may result in a deflection of approximately 0.004
inches. The resistance
to bending may also be characterized by the strain of the outer surface before
fracture or
permanent deformation. By taking measurements of the support structure and the
deflections
during the test procedure, a load deflection curve may be generated and the
flexural modulus of
the support structure may also be calculated. In some variations, the support
structure may
comprise a flexural modulus of at least about 0.9 GPa, while in other
embodiments, the flexural
modulus is at least about 1 GPa, at least about 1.1 GPa, at least about
1.2GPa, at least about 1.3
GPa, or at least about 1.4 GPa.
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In another example, a device of 7 cm wide by 19 cm long may be configured with
a
support structure comprising a paperboard, support sheet or support structure.
The support
structure may have an average thickness in the range of about 0.008" to about
0.028" or greater.
In some specific variations, the support structure may have a thickness of
about 0.012", about
0.016-, about 0.018-, about 0.024-, about 0.28- or about 0.032-, about 0.036-,
about 0.04-,
about 0.05" or greater. Upon the application of force along the lengthwise
edge of the 19
centimeter length, i.e. across the 7 cm width of the device, the support
structure may provide
sufficient rigidity or column strength to achieve peak forces of about 3 pound
or more, 4 pounds
or more, or of about 10 pounds or more, while being compressed, collapsed,
bowed, buckled or
otherwise deformed by 25% along its 7 cm width (i.e. about 1.75 cm). In some
variations, the
support structure may comprise scoring or regions of reduced thickness to
permit some bending
it at least one direction or in both directions.
According to some variations, a device that provides structural support may
have a
plurality or supporting cross elements or segments extending from one edge of
the length to an
opposing edge or the length (or from one edge of a width to an opposing edge
of a width);
According to some variations there may be three or more cross elements, e.g.,
a cross element
extending along two opposing edges and transversely across a width (or a
length) and one or
more cross elements extending across the width ( or length) and between the
cross elements
along the two opposing edges. Such cross elements may or may not be coupled or
connected to
each other, for example, with a relatively flexible material. Such cross
elements may have a total
aggregate width with respect to the length of an opposing edge of about 20% or
more, about 25%
or more, about 30% or more, or about 35% or more. According to some
variations, one or more
cross elements may be provided that have a total aggregate width, relative to
the length of the
opposing side, between about 20% to 100%. Such cross elements may be segmented
and may
provide flexibility when bending in a direction and rigidity relative to the
flexibility, in another
direction.
The packaging and/or applicator may also provide structural support or
stability of the
dressing as it is oriented and/or applied to the skin of a subject. According
to some variations,
the dressing and packaging is configured to be pre-oriented in a position
facing a wound before
or after the wound device is prepared for application, e.g., the adhesive
liner is removed.
According to some variations, the packaging or applicator is configured to be
used with one hand
to orient and/or apply the device to the skin of a subject. For example, in
some situations,
particularly where a longer or larger dressing is used, a packaging or
applicator provides
structural support for a dressing such that a user can effectively hold onto,
manipulate and/or
apply a prepared dressing with one-hand. According to some variations, the
assembly
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comprises a support structure. A dressing support structure is defined herein
to mean a structure
that is coupled whether directly or indirectly, to a back surface of a
dressing that is to be applied
to a subject. The support structure may further comprise at least in part, a
material or structure
that is more rigid than the dressing to be applied to a subject. The support
structure may
comprise one or more elements or segments. It may be constructed of a single
substrate, a
laminate or a plurality of elements coupled together and/or to the dressing.
According to some
variations at least 20%, 25%, 30%, 35%, or 40% of a length or width of the
dressing is supported
by one or more support structures extending from a first opposing side to an
opposite side along
a length or width of the dressing. In some further variations, the percentage
of a length or width
that is supported by the support structure(s) is a minimum average of support
across the entire
length or entire width of the device, e.g. at least a 20%, 25%, 30%, 35% or
40% average support
across an entire dimension of the device, e.g. length or width. According to
some variations, an
entire area of a dressing is supported by a support structure. According to
some variations, a
base, carrier or support of a dressing may comprise at least three support
structures extending
transversely between opposing sides of the dressing. According to some
variations, a support
structure comprises interconnected members or elements. According to some
variations, a base,
carrier or support remains coupled to the dressing as it is applied. According
to some variations,
greater structural support is provided to a dressing carrier, support or base
in a first direction
while greater flexibility is provided in a second direction, while lesser
flexibility is in the first
direction and lesser structural support is provided in the second direction.
According to some
variations, one or more support structures may extend beyond an edge of the
first opposing side.
According to some variations, one or more support structures, at least in
part, may extend
beyond at least a portion of an edge of a first opposing side and at least in
part beyond at least a
portion of an edge of an opposite side. According to some variations, a
support structure may
extend at least 3 mm from at least a portion of an edge of the dressing.
According to some
variations, the packaging or applicator is configured to improve a sterile
transfer of a dressing to
a wound of a subject. According to variations, the packaging or applicator may
be sufficiently
wider or longer, or have a sufficiently larger area than a dressing providing
the ability to
maneuver or manipulate the support or applicator so that it provides sterile
application and/or
one-handed application without the need to touch the dressing According to
some variations, a
margin of distance is provided from the outer edges of the dressing carrier,
support or base to the
dressing supported on the base or adhesive on the dressing. Such margins may
be selected to
prevent or resist a user from touching the dressing or dressing adhesive when
grasping the edges
to manipulate the dressing carrier, support, applicator or base.
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Devices, kits and methods described herein may be for the treatment,
amelioration, or
prevention of scars and/or keloids by creating and/or maintaining a pre-
determined strain in an
elastic skin treatment device that is then affixed to the skin surface using
skin adhesives to
transfer a generally planar(e.g. compressive) force from the bandage to the
skin surface.
In some variations, a dressing is provided, comprising an elastic sheet
structure (e.g., a
comprising a silicone polyurethane, TPE (thermoplastic elastomers), synthetic
rubber or co-
polyester material) comprising an upper surface, a lower surface, a first edge
and a second edge
opposite the first edge, and one or more adhesive regions. The dressing may
further comprise a
first release liner releasably attached to the adhesive region or regions. The
adhesive region(s)
may comprise a pressure sensitive adhesive. The dressing may be tapered or
otherwise shaped
to reduce skin tension at the edges. The dressing may have modified, reduced
or no adhesive
near its edges to reduce skin tension at the edges. Portions of the dressing
may be unstrained and
may thereby reduce strain in certain areas of the skin where the dressing is
applied. In some
specific examples, the unstrained area or areas are found between the edges of
the dressing and
the strained area(s). In some further examples, the unstrained areas are
limited to this area and
are not found, during application or use, between the strained areas of a
single dressing, in use.
In still further examples, the unstrained areas are limited to areas along the
edges of a dressing
that intersect the strain axis of the strained area(s), but not to areas along
the edges of the
dressing that are generally parallel to the strain axis.
A packaging device, dressing carrier, dressing support, dressing base,
applicator and/ or
tensioning device may be provided. The packaging device, dressing carrier,
dressing support,
dressing base, applicator and/or tensioning device may be configured to stress
and/or strain a
dressing prior to application to a subject. A device may be used to strain
and/or maintain a strain
on a dressing. In one variation, a dressing is provided, comprising a first
device attachment
structure, zone or region, a second device attachment structure, zone or
region, and a structure or
mechanism configured to exert a separation force between the first and second
device attachment
structures, zones or regions. The device may further comprise a releasable
locking mechanism,
attachment mechanism or adhesive, configured to maintain the member or
mechanism in a
strained configuration.
In some situations, application of a compressive force to a wound is desirable
to reduce
bleeding. According to some variations, the packaging, carrier, support, base,
applicator or
tensioning device described herein may be further used to help reduce
bleeding, e.g., by allowing
application of a compressive force using the device while or after the
dressing is applied. A
coagulative additive may also be provided on a dressing.
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According to one aspect, the packaging, carrier, support, base, applicator
and/or tensioning
device may be sufficiently rigid or supportive in at least one direction, to
hold a dressing's form
so that it is easy to manipulate.
According to some variations, the packaging is also sufficiently flexible in
at least one
direction to permit curving or shaping of the dressing to conform to the
curvature or shape of the
location on the body or skin where the dressing is applied. Generally, the
flexibility of the
packaging used to conform the dressing to the treatment site may be configured
so that the
treatment site is not substantially deformed during the application of the
dressing; so that the
application of the dressing is relatively smooth or uniform on the skin;
and/or provides a
uniform, predetermined, or relatively predictable strain or force to an area
of skin The packaging
or applicator may have flexibility in a first direction and greater rigidity
in another direction.
The packaging or applicator may include elements or segments that permit
flexibility with
respect to adjacent elements or segments.
According to some variations, the packaging is also sufficiently flexible in
at least one
direction to permit curving or shaping of the dressing to conform to the
curvature or shape of the
location on the body or skin where the dressing is applied. Generally, the
flexibility of the
packaging used to conform the dressing to the treatment site may be configured
so that the
treatment site is not substantially deformed during the application of the
dressing; and/or so that
the application of the dressing is relatively smooth or uniform on the skin;
and/or provides a
uniform, predetermined, or relatively predictable strain and/or force to an
area of skin. The
packaging or applicator may have flexibility in a first direction and greater
rigidity in a second
direction. The first direction may be transverse to the direction of straining
or have a component
that is transverse to the direction of straining. The second direction may by
the direction of
straining or have a component that is in the direction of straining. The first
direction may or may
not be transverse with respect to the second direction. The packaging or
applicator may include
elements or segments that permit flexibility with respect to adjacent elements
or segments.
According to some variations a desired flexibility, for example having at
least one
component transverse to the direction of straining, may be characterized by a
modified
cantilevered beam bending model, i.e. applying a force to the free end of a
beam, simply
supported from the other end, while wrapping it around a cylindrical object
with a known radius
of curvature or curvature, defined as the reciprocal of the radius of the
curvature. According to
one variation, the force to bend the packaging or applicator around an object
with a
predetermined curvature may be no greater than about 3 pounds. According to
one variation,
the force may be no greater than about 0.3 pounds. According to one variation,
the force to bend
around a predetermined curvature of about a 2.5 inch radius may be no greater
than about 3
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pounds. In another variation, the force to bend around a predetermined
curvature of about a 2.5
inch radius may be no greater than about 0.3 pounds.
According to some variations, a packaging, applicator or tensioning device is
provided
comprising a base having an inner surface to which a dressing is removably
attached, and a cover
or lid having an inner surface interfacing the inner surface of the base when
in an initial closed
configuration. According to some variations, the base and cover are coupled at
corresponding
edges along their corresponding lengths to form a book-like structure whereby
the cover may be
rotated with respect to the base to open the device. Alternatively the cover
may be lifted off of
the base. According to variations, a liner is attached to the cover and will
expose an adhesive
side of a dressing when the cover is lifted or opened.
In some variations, the book-like structure, in the closed configuration,
comprises a layered
structure comprising a cover/lid, a treatment device and a base, in that
relative order, while in the
open configuration, the relative order of the layered structure changes to a
cover/lid, a base, and
a treatment device. The treatment device may also comprise one or more release
layers. In one
variation, in the closed configuration, a first face of the cover/lid is in
contact with a first face of
the treatment device, and a first face of the base is in contact with the
second surface of the
treatment device opposite the first surface, while in the open configuration,
a second face of the
cover/lid (opposite the first face of the cover/lid) is in contact with a
second face of the base
(opposite the first face of the base) but not with the first face of the
treatment device. In some
variations, the cover/lid may be separated from the base during or after
tensioning of the
treatment device. In some variations, the treatment device may be attached
asymmetrically to
the book-like structure, relative to the bending region of the book-like
structure. In some
instances, the asymmetric attachment may provide the user with a mechanical
advantage when
tensioning the dressing, and/or may reduce manufacturing costs by optimizing
the amount of
elastic material used in the dressing. In other variations, the dressing or
skin treatment device
may be attached symmetrically to the book-like structure, relative to the
bending region of the
book-like structure.
In another embodiment, a method of applying a dressing to a surface is
provided.
According to some variations the method may comprise providing a dressing
packaging
comprising: an applicator comprising a base structure having an inner surface
and a manipulation
portion; a dressing comprising a first surface configured to be applied to a
skin or wound of a
subject; and a back surface, wherein the back surface of the dressing is
removably coupled or
anchored to the inner surface of the base structure, and wherein the first
surface faces away from
the inner surface of the base structure; and a cover configured to removably
cover the first
surface of the dressing. A method may further comprise removing the cover to
expose a first
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surface of a dressing; and using the manipulation portion of the base
structure to apply the first
surface of the dressing to a wound or skin of a subject. In another variation,
a method for
treating a wound is provided, comprising straining an inner region of an
elastic bandage between
a first unstrained region and a second unstrained region, and attaching at
least the strained inner
region of the dressing to a skin site or both strained and unstrained regions.
According to some variations, a dressing packaging assembly comprises: a base
structure
having an inner surface; a cover structure having an opposing surface, wherein
the base structure
is movably coupled to the cover structure; and a dressing comprising a first
surface configured to
be applied to a wound or skin of a subject, and a back surface, wherein at
least a portion of the
back surface is removably coupled to the inner surface of the base structure;
and wherein the
cover structure is configured to move from a first position where the opposing
surface interfaces
with and is substantially parallel to the first surface to the dressing to a
second position where the
opposing surface is separated from the first surface of the dressing.
According to variations, the
first surface of the dressing comprises an adhesive region. According to
variations the first
surface of the dressing comprises an adhesive backing interfacing an adhesive
region on the
dressing. According to variations, the opposing surface of the cover structure
comprises an
adhesive backing covering the adhesive region when the cover structure is in
the first position
and separated from the adhesive region when the cover structure is in the
second position.
According to variations, the dressing comprises an elastic material. According
to variations, the
dressing comprises a first attachment region coupled to the inner surface of
the base structure
and a second attachment region coupled to the opposing surface of the cover
structure, wherein
the cover and base are configured to exert a straining force to strain the
dressing when the cover
is moved from the first position to the second position. According to
variations, a tensioning
structure is configured to exert the straining force on the dressing.
According to variations, the
tensioning structure comprises: a first structure configured to couple the
dressing at the first
attachment region to the inner surface of the base structure; and a second
structure configured to
couple the dressing at the second attachment region to the opposing surface of
the cover; wherein
the tensioning structure is configured to exert the straining force to the
dressing between the first
attachment region and the second attachment region when the cover structure is
moved with
respect to the base structure from the first position to the second position.
According to some
variations, the dressing has a first width when the cover is in the first
position and a second width
when the cover is in the second position, wherein the second width is greater
than the first width.
According to variations, the second width is at least 20% greater than the
first width. According
to variations, the second width is at least 40% great than the first width.
According to variations,
the base structure comprise at least one relatively rigid element and at least
one relatively
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flexible element, wherein the relatively rigid element is sufficiently rigid
to support the dressing
when the straining force is applied in a first direction; and wherein the
relatively flexible element
permits the base structure to flex in a second direction. According to
variations, the at least one
relatively rigid element comprises a plurality of flexible coupled, relatively
rigid elements.
According to variations, the cover structure comprises at least one relatively
rigid element and at
least one relatively flexible element. According to variations, a release
device is configured to
release the dressing from the base structure after the dressing is applied to
a wound or skin of a
subject. According to some variations, base structure is pivotably coupled to
the cover structure.
According to variations, a dressing packaging assembly comprises: a base
structure having
an inner surface and comprising at least one support element and at least one
flexible element;
and a dressing comprising a first surface configured to be applied to a wound
or skin of a subject,
and a back surface, wherein at least a portion of the back surface is
removably coupled to the
inner surface of the base structure. According to variations, the at least one
rigid element
comprises a plurality of rigid elements coupled to each other with the at
least one flexible
element. According to variations, a cover structure comprises an opposing
surface configured to
interface with the first surface of the dressing, wherein the cover structure
is moveably coupled
to the base structure to move from a first position where the opposing surface
interfaces with the
first surface of the dressing, to a second position where the cover is
separated from the first
surface of the dressing. According to variations, the cover structure is
pivotably coupled to the
base structure. According to variations, the cover structure comprises at
least one support
element and at least one flexible element sufficiently flexible to permit
shaping of the cover
structure. According to variations, the first surface of the dressing
comprises an adhesive region.
According to variations, the first surface of the dressing comprises an
adhesive backing
interfacing an adhesive region on the dressing. According to variations, the
opposing surface of
the cover structure comprises an adhesive backing covering the adhesive region
in the first
position and separated from the adhesive region in the second position.
According to variations,
the dressing comprises and elastic material. According to variations, the
dressing comprises a
first attachment region coupled to the inner surface of the base structure and
a second attachment
region coupled to the opposing surface of the cover structure, wherein the
cover and base are
configured to exert a straining force to strain the dressing when the cover is
moved from the first
position to the second position. According to variations, the assembly further
comprises a
tensioning structure configured to exert the straining force on the dressing.
According to
variations, the tensioning structure comprises: a first structure configured
to couple the dressing
at the first attachment region to the inner surface of the base structure; and
a second structure
configured to couple the dressing at the second attachment region to the
opposing surface of the
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cover wherein the tensioning structure is configured to exert the straining
force to the dressing
between the first attachment region and the second attachment region when the
cover structure is
moved with respect to the base structure from the first position to the second
position. According
to variations, the dressing between the first and second attachment regions
has a first width when
the cover is in the first position and a second width when the cover is in the
second position,
wherein the second width is greater than the first width. According to
variations, the second
width is at least 4% greater than the first width. According to variations,
the second width is at
least 20% greater than the first width. According to variations, the second
width is at least 40%
great than the first width.
According to variation, a method of applying a dressing to a wound or skin of
a subject
comprises: providing a dressing packaging assembly comprising: a base
structure having an
inner surface; a cover structure having an opposing surface, wherein the base
structure is
movably coupled to the cover structure; and a dressing comprising a first
surface including an
adhesive region, and a back surface, wherein at least a portion of the back
surface is removably
coupled to the inner surface of the base structure, and wherein the opposing
surface of the cover
structure comprises an adhesive backing covering the adhesive region when the
cover structure is
in the first position; pivoting the cover structure with respect to the base
structure to a second
position to separate the opposing surface from the first surface of the
dressing and to separate the
adhesive backing from the adhesive region; applying the first surface of the
dressing to a wound
or skin of a subject, then subsequently releasing the dressing from the base
structure. According
to variations of the method, at least a portion of the back surface of the
dressing is coupled to the
cover structure and further comprising pivoting the cover structure with
respect to the base
structure to strain the dressing.
According to variations, a dressing applicator comprises a first dressing
attachment region
and a second dressing attachment region comprising a variable separation
distance between the
first dressing attachment region and the second dressing attachment region,
and a bending region
between the first dressing attachment region and the second dressing
attachment region that
alters the variable separation distance, and wherein a first distance from a
center of the bending
region to the first dressing attachment area is different from a second
distance from the center of
the bending region to the second dressing attachment area
According to variations, a dressing tensioning device comprises: a dressing
carrier
comprising a first carrier edge and a second opposing carrier edge defining a
carrier width
therebetween; a tensioning element configured to move with respect to the
dressing carrier from
a first position to a second dressing tensioning position; and a dressing
assembly comprising a
dressing including a first dressing edge coupled to the carrier adjacent the
first carrier edge; a
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second dressing edge coupled to an attachment element wherein the attachment
element coupled
to the tensioning element; wherein in the first position of the tensioning
element, the second
dressing edge is a first distance from the second carrier edge within the
width of the carrier, and
in the second position of the tensioning element, the second dressing edge is
a second distance
from the second carrier edge within the width of the carrier, wherein the
first distance is greater
than the second distance. According to variations, the first dressing edge is
relatively fixed with
respect to the second dressing edge when the tensioning element is moved
between the first and
second positions.
According to variations, a dressing packaging assembly comprises: a base
structure
having an inner surface; a cover structure having an opposing surface, wherein
the base structure
is movably coupled to the cover structure; and a dressing comprising a first
surface configured to
be applied to a wound or skin of a subject, and a back surface, wherein at
least a portion of the
back surface is removably coupled to the inner surface of the base structure;
wherein the cover
structure is configured to move from a first position where the opposing
surface interfaces with
the first surface to the dressing to a second position where the opposing
surface is separated from
the first surface of the dressing where the second position is at least about
180 degrees rotated
with respect to the first position. According to variations, the first surface
of the dressing
comprises an adhesive region. According to variations, the first surface of
the dressing
comprises an adhesive backing interfacing an adhesive region on the dressing.
According to
variations, the opposing surface of the cover structure comprises an adhesive
backing covering
the adhesive region when the cover structure is in the first position and
separated from the
adhesive region when the cover structure is in the second position. According
to variations, the
dressing comprises an elastic material. According to variations, the dressing
comprises a first
attachment region coupled to the inner surface of the base structure and a
second attachment
region coupled to the opposing surface of the cover structure, wherein the
cover and base are
configured to exert a straining force to strain the dressing when the cover is
moved from the first
position to the second position. According to variations, the assembly further
comprises a
tensioning structure configured to exert the straining force on the dressing.
According to
variations, the tensioning structure comprises: a first structure configured
to couple the dressing
at the first attachment region to the inner surface of the base structure; and
a second structure
configured to couple the dressing at the second attachment region to the
opposing surface of the
cover; wherein the tensioning structure is configured to exert the straining
force to the dressing
between the first attachment region and the second attachment region when the
cover structure is
moved with respect to the base structure from the first position to the second
position.
According to variations, the dressing has a first width when the cover is in
the first position and a
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second width when the cover is in the second position, wherein the second
width is greater than
the first width. According to variations, the second width is at least 20%
greater than the first
width. According to variations, the second width is at least 40% great than
the first width.
According to variations, the base structure comprises at least one relatively
rigid element and at
least one relatively flexible element, wherein the relatively rigid element is
sufficiently rigid to
support the dressing when the straining force is applied in a first direction;
and wherein the
relatively flexible element permits the base structure to flex in a second
direction.
According to variations, a dressing packaging comprises: a dressing carrier
comprising a
first carrier edge, a second carrier edge opposing the first carrier edge, and
a support structure
extending between the first edge and the second edge, configured to support a
dressing during
application of the dressing to a subject; and a dressing comprising a first
dressing edge, a second
dressing edge opposing the first dressing edge, a back surface and an opposing
skin interfacing
surface, wherein at least a portion of the back surface is removably coupled
to the dressing
carrier wherein the first dressing edge and the second dressing edge are
positioned between the
first carrier edge and the second carrier edge, and wherein the first dressing
edge defines a first
margin between the first dressing edge and the first carrier edge and the
second dressing edge
defines a second margin between the second dressing edge and the second
carrier edge, wherein
each of the first and second margins have a width of at least three
millimeters.
In one variation, a dressing system is provided, comprising a first support, a
second
support, and a primary bending region therebetween, the primary bending region
comprising a
primary bending axis, and a treatment device comprising a first attachment
region attached to the
first support and a second attachment region attached to the second support, a
first separation
region configured to separate from first attachment region and a second
separation region
configured to separate from the second attachment region. The first and second
separation
regions may comprise perforations. The dressing system may further comprise a
pull element
located along the perforations. The treatment device may be asymmetrically
attached to the first
and second supports, relative the primary bending region. A first distance
between the first
support and the primary bending axis may be different from a second distance
between the
second support and the primary bending axis. The dressing system may further
comprise a
closed configuration wherein the treatment device is located between the first
support and the
second support, and a closed configuration wherein the second support is
located between the
first support and the treatment device. The second support may comprise at
least one secondary
bend region comprising a secondary bending axis that is not parallel to the
primary bending axis.
The secondary bending axis may be orthogonal to the primary bending axis. The
first support
may comprise at least one secondary bend region comprising a secondary bending
axis that is not
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parallel to the primary bending axis. The at least one secondary bend region
of the first support
may be aligned with the at least one secondary bend region of the second
support. The treatment
device may further comprise a release liner coupled to an adhesive surface of
the treatment
device. The treatment device may comprise a perforation region. The dressing
system may
further comprise an elongate element attached adjacent to the perforation
region. The elongate
element may protrude beyond the perforation region of the treatment device. In
some variations,
at least a portion of the elongate element may be folded, and the fold may be
along a substantial
length of the treatment device. At least one of the first and second supports
may comprise
indicia identifying a center region of the treatment device. The indicia may
comprise a recessed
edge, ink mark, embossing, or window. The primary bending region may also
perforated. The
first support may be configured to detach from the second support and the
treatment device, and
may or may not do so while maintaining the treatment device in a strained
configuration. The
second support may comprise an adhesive element configured to adhere to the
treatment device
when the dressing system is in the open configuration but not in the closed
configuration. The
first support may comprise an attached release liner. The release liner may be
attached to the
first support between an outer edge of the first support and the attached
treatment device. An
inner surface of the first and/or second support facing the treatment device
may include an
adhesive, such as an adhesive coating or adhesive tape, which is configured to
maintain the
treatment device either in a tensioned state as it is stretched and contacts
the adhesive, and/or to
maintain the treatment device against the first and/or second supports.
In another variation, a dressing system is provided, comprising a first
tensioning member, a
second tensioning member, and a primary bending region therebetween, the
primary bending
region comprising a primary bending axis, and a treatment device
asymmetrically attached to the
first and second tensioning members, relative the primary bending region. The
treatment device
may comprises a first end attached to the first tensioning member and a second
end attached to a
second tensioning member, wherein a first distance between the first
tensioning member and the
primary bending axis is different from a second distance between the second
tensioning member
and the primary bending axis. The dressing system may further comprise a
closed configuration
wherein the treatment device is located between the first tensioning member
and the second
tensioning member, and an open configuration wherein the second tensioning
member is located
between the first tensioning member and the treatment device. The second
tensioning member
may comprise at least one secondary bend region comprising a secondary bending
axis that is not
parallel to the primary bending axis. The secondary bending axis may be
orthogonal to the
primary bending axis. The first tensioning member may comprise at least one
secondary bend
region comprising a secondary bending axis that is not parallel to the primary
bending axis. The
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at least one secondary bend region of the first tensioning member may be
aligned with the at
least one secondary bend region of the second tensioning member. The treatment
device may
further comprise a release liner coupled to an adhesive surface of the
treatment device. The
treatment device may comprise a perforation region. The dressing system may
further comprise
an elongate element attached adjacent to the perforation region. The elongate
element may
protrude beyond the perforation region of the treatment device. In some
variations, at least a
portion of the elongate element may be folded, and the fold may be along a
substantial length of
the treatment device. At least one of the first and second tensioning members
may comprise
indicia identifying a center region of the treatment device. The indicia may
comprise a recessed
edge, ink mark, embossing, or window. The primary bending region may be
perforated. The
first tensioning member may be configured to detach from the second tensioning
member and
the treatment device. The first tensioning member may be configured to detach
from the second
tensioning member and the treatment device while maintaining the treatment
device in a strained
configuration. The second tensioning member may comprise an adhesive element
configured to
adhere to the treatment device when the dressing system is in the open
configuration but not in
the closed configuration. The first tensioning member may comprise an attached
release liner.
The release liner may be attached to the first tensioning member between an
outer edge of the
first tensioning member and the attached treatment device.
In another variation, a dressing system is provided, comprising a first
applicator member, a
second applicator member, and a primary bending region therebetween, the
primary bending
region comprising a primary bending axis, and a treatment device attached to
the first and second
applicator members, wherein the dressing system comprises a closed
configuration wherein the
treatment device is located between the first applicator member and the second
applicator
member, and a closed configuration wherein the second applicator member is
located between
the first applicator member and the treatment device. The second applicator
member may
comprise at least one secondary bend region comprising a secondary bending
axis that is not
parallel to the primary bending axis. The secondary bending axis may be
orthogonal to the
primary bending axis. The first applicator member may comprise at least one
secondary bend
region comprising a secondary bending axis that is not parallel to the primary
bending axis. The
at least one secondary bend region of the first applicator member may be
aligned with the at least
one secondary bend region of the second applicator member. The treatment
device may further
comprise a release liner coupled to an adhesive surface of the treatment
device. The treatment
device may comprise a perforation region. The dressing system may further
comprise an
elongate element attached adjacent to the perforation region. The elongate
element may protrude
beyond the perforation region of the treatment device. At least a portion of
the elongate element
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may be folded, and the fold may be along a substantial length of the treatment
device. At least
one of the first and second applicator members may comprise indicia
identifying a center region
of the treatment device. The indicia may comprise a recessed edge, ink mark,
embossing, or
window. The primary bending region may be perforated. The first applicator
member is
configured to detach from the second applicator member and the treatment
device. The first
applicator member may be configured to detach from the second applicator
member and the
treatment device while maintaining the treatment device in a strained
configuration. The second
applicator member may comprise an adhesive element configured to adhere to the
treatment
device when the dressing system is in the open configuration but not in the
closed configuration.
The first applicator member may comprise an attached release liner. The
release liner may be
attached to the first applicator member between an outer edge of the first
applicator member and
the attached treatment device.
Devices kits and methods herein may include a support, packaging and/or
applicator
configured to maintain a pre-strained dressing in a strained configuration for
a period of time
after straining and prior to application to skin of a subject. Devices and
methods herein may
include a method of manufacturing such a pre-strained dressing.
According to one variation, a pre-strained and strain shielded dressing
assembly may be
stored for a period of time after straining and prior to use. In some
variations, the dressing may
be configured to maintain a predictable and/or desired amount of tensile force
during a pre-
determined period of time after initial straining. In some variations, the
dressing may be
configured to lose a predetermined maximum and/or minimum amount of tensile
force
(measured in a direction of tensile straining of the dressing) during one or
more periods of time.
A desired time for application of the dressing to a subject may be when the
dressing, in its
pre-strained and strain shielded configuration, has a tensile force
characteristic or range thereof
that is desired. Such desired range may be selected to provide sufficient
modulation of the
forces on the skin to treat the skin while avoiding or minimizing disruption
irritation to the skin.
As noted herein, for a given dressing, different levels of stress or strain
may be imparted to the
skin at different locations and/or on different subjects. Also different
levels of force offloading
may be desirable for different individuals or different locations on a
subject's skin. Thus
different ranges of dressing force properties may be appropriate for different
skin treatment
applications.
Such desired force range may be selected based on a determination desired
force properties
to be applied to a particular subject, portion of skin and/or for a particular
skin treatment
purpose. Such desired force may be high enough to provide a therapeutic
mechanomodulation
of the skin while be low enough to prevent significant skin irritation.
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Force properties of a pre-strained dressings may vary over time. An initial
strain may be
applied to the dressing where the elastic material or other structure, of the
dressing has an initial
tensile force characteristic. The dressing may be maintained in a strained
configuration at a
particular strain level after it is pre-strained for an initial period of
time. During the initial period
of time, the force properties of the elastic material may diminish, decay or
exhibit a loss of force.
After an initial predetermined period of time, the force properties of the
elastic material may
reach, diminish to or decay to a desired force level and/or range of force
levels. The dressing
elastic material force characteristics may be within the desired range for at
least a subsequent
period of time. In some variations, the dressing material may have an elastic
modulus in the
range of about 1 MPa to about 15 MPa, sometimes about 1.5 MPa to about 6 MPa,
and other
times about 2 MPa to about 5 MPa, about 3 MPa to about 4 MPa, or about 3.5 MPa
to 5 MPa,
while having a peak load per width up to a 0.6 strain of less than 3N/mm,
sometimes less than
about 2.5 N/mm, sometimes less than 2 N./mm, sometimes less than 1 N/mm,
sometimes less
than about 0.75N/mm and other times less than about 0.6N/mm or less than about
0.5N/mm.
The peak load per width up to a 0.6 strain, may be at least about 0.35N/mm,
sometimes at least
about 0.5N/mm, and other times at least about 0.6N/mm, 0.7 N/mm, 0.8 N/mm, 0.9
N/mm or 1
N/mm. The material may be selected such that the material, at a constant
engineering strain of
20%, is able to maintain an engineering stress of at least about 200 kPa, 250
kPa, 300kPa, 400
kPa, or 500 kPa, 1000 kPa, 1500 kPa, 2000 kPa, 2500 kPa, 3000 kPa or more for
at least 8 hours
with less than a 10% or 5% variation or decrease in engineering stress.
According to a variation, for example, the initial force or strain properties
of a dressing
may be selected so that the desired range of force values occur during a
period of time where the
percentage loss of force is reduced and occurs over a longer period of time.
The initial strain and/or force level of the dressing may be selected so that
the time of use
falls within a desired time frame or period based on the percentage loss of
force of the dressing
over time.
According to variations, the dressing may be initially strained or over-
stressed to provide a
greater initial force per unit width than that of a desired range at the time
of application to skin.
According to variations, the initial strain and resulting initial force per
width of a dressing may
be selected based on desired final and resulting force properties and/or a
desired time frame for
use of the dressing. Such initial strain level may be, for example, 20% or
more, 30% or more,
40% or more, 50% or more, 60% or more, 70% or more, 80% or more, 90% or more,
100% or
more. According to variations, the initial force is greater than a desired
force range. Such
initial force level may be for example about or up to 25%, about or up to 35%,
about or up to
50%, about or up to75% or more than the desired force at time of application
of the dressing.
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Such initial force level may be but is not limited to, for example, between 2
and 5 Lbf/inch, 1.54
and 3.85 Lbf/inch, 1.33 and 3.33 Lbf/inch. or 0.85 to 2.20Lbf/inch
According to variations, a dressing may be configured to be initially strained
or tensile
stressed to a desired strain or force level and maintained in the strained
configuration for an
initial time frame. According to variations, the initial time frame may be,
for example, 1 hour or
more, 1 day or more, 1 week or more, or up to 1 month or more prior to
application. According
to variations, the initial time frame may be lhour or more, 1 day or more, 1
week or more, or up
to 1 month or more in a material pre-conditioning state prior to final
assembly or manufacture.
Such preconditioning state may be straining the material at a constant strain
or straining the
material at varied levels of strain.
Then according to some variations, for the duration of a subsequent pre-
determined time
frame after the initial time frame, the dressing may be configured to maintain
a desired minimum
final force or force range. During the subsequent time frame, the device may
be applied to a
subject's skin for treatment. Such desired force range may be from about 0.5
to 1.0 Lbf/inch, 1.0
to 2.5 Lbf/inch or from about 1.6 to 2.1 Lbf/inch. The force loss during the
subsequent time
period may be up to 3%, up to 5%, up to 8%, up to 10%, up to 15%, up to 20%,
up to 25% or
more. The duration of the subsequent time period may be, for example 2 months,
or more 3
months or more, 6 months or more, 12 months or more, 36 months or more, or 48
months or
more.
The pre-strained dressing may then be coupled to a strain maintaining element
during an
initial period of time. The strain maintaining element may remain on the
dressing during a
portion of the subsequent period of time until it is used.
According to a variation for example, the average initial force or strain
properties (average
may include or may comprise an average, for example, per manufacturing lot, or
a specified
average within a given tolerance level) of a dressings pre-strained at
manufacturing may be
provided so that the desired range of average force values occur during a
period of time where
the average percentage loss of force is reduced and occurs over a longer
period of time. In other
variations, the pre-straining is initiated at the point-of-use. In still other
variations, a portion of
the pre-straining is performed at the point-of-manufacture, and additional
straining or strain
relief is performed at the point-of-use. After pre-straining, the dressing may
then he packaged,
sealed and sterilized for future use.
The initial average strain and/or force level of the dressings may be selected
so that the
time of use falls within a desired time frame or period based on the average
percentage loss of
force of the dressings over time.
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According to variations, the dressings may be initially strained or over-
stressed to provide
a greater average initial force per unit width than that of a desired range at
the time of application
to skin. According to variations, the average initial strain and resulting
initial force per width of a
dressing may be selected based on desired final and resulting force properties
and/or a desired
time frame for use of the dressing. Such average initial strain level may be,
for example, less
than 20%, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, 70%
or more,
80% or more, 90% or more, 100% or more. According to variations, the average
initial force is
greater than a desired force range. Such average initial force level may be
for example about or
up to 25%, about or up 35%, about or up to 50%, about or up to75%, or more
than the desired
force at the time of application of the dressing. Such average initial force
level may be but is not
limited to, for example, between 2 and 5 Lbf/inch, 1.54 and 3.85 Lbf/inch,
1.33 and 3.33
Lbf/inch. or 0.85 to 2.20Lbf/inch
According to variations, a dressing may be configured to be initially strained
or tensile
stressed to a desired average strain or force level and maintained in the
strained configuration for
an initial time frame. According to variations, the initial time frame may be
lhour or more, 1
day or more, 1 week or more, or up to 1 month or more prior to application.
According to
variations, the initial time frame may be lhour or more, 1 day or more, 1 week
or more or up to 1
month or more in a material pre-conditioning state prior to final assembly or
manufacture. Such
preconditioning state may be straining the material at an average constant
strain or straining the
material at varied levels of average strain.
Then according to some variations, for the duration of a subsequent pre-
determined time
frame after the initial time frame, the dressings may be configured to
maintain a desired
minimum average final force or average force range. During the subsequent time
frame, the
devices may be applied to a subject's skin for treatment. Such desired average
force range may
be from about 0.5 to 1.0 Lbf/inch, 1.31 Lbf/inch to 1.41 Lbf/inch. The average
force loss during
the subsequent time period may be up to 3%, up to 5%, up to 8%, up to 10%, up
to 15%, up to
20%, up to 25% or more. The duration of the subsequent time period may be, for
example 2
months or more, 3 months or more, 6 months or more, 12 months or more, 36
months or more,
or 48 months or more.
A pre-strained dressing may be coupled to a strain maintaining element during
an initial
period of time during one or more manufacturing steps. The strain maintaining
element may
remain on the dressing during a portion of the subsequent period of time
during manufacturing or
in transport or storage until it is used.
In another example, a method for modulating tissue response at a target site
is provided,
comprising providing a strained elastic structure with an access opening and a
support structure,
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placing the strained elastic structure against a target site, releasing the
strained elastic structure
from the support structure, and inserting an access structure into the target
site, wherein the
access structure is located in the access opening. The strained elastic
structure may be an elastic
sheet with an adhesive layer. Attaching the strained elastic structure to the
target site may
comprise adhering the strained elastic structure to a skin location. The
support structure may
comprise at least one pull tab, and releasing the strained elastic structure
from the support
structure may comprise actuating the pull tab to release the strained elastic
structure from the
support structure. The method may further comprise inserting the access
structure through the
access opening. The access structure may be a delivery tube, and wherein the
method may
further comprise passing a sensor or infusion carmula using the delivery tube.
The access
structure may be attached to a housing. The housing may comprises a skin
configured to attach
the housing to a skin surface. The housing may further comprise a support
layer, and the
adhesive may be located on the inferior surface of the support layer. The
method may further
comprise adhering the housing to the elastic structure. The method may further
comprise
releasing the access structure from a delivery device after inserting the
access structure into the
target site. The method may further comprise aligning the delivery device with
indicia or
alignment structures located on the strained elastic structure.
In another embodiment, a tissue treatment device is provided, comprising a
strained elastic
layer comprising a top surface, a bottom surface and a treatment opening, a
skin adhesive layer
adhered to the bottom surface of the strained elastic layer, a protective
layer releasably
contacting the adhesive layer, a strain support removably attached to the top
surface of the elastic
layer, the strain support comprising a layer structure with a center opening
surrounding the
treatment opening of the strained elastic layer, the strain support having
sufficient rigidity to
maintain the strained elastic layer in a strained configuration, and at least
one alignment structure
located on the strain support and surrounding the center opening of the strain
support. The strain
support may further comprise a perforation region from the center opening to
an edge of the
strain support. The alignment structure may comprise a separation region
aligned with the
perforation region of the strain support. The strain support may comprise a
first end, a second
end, and an arcuate body therebetween defining the center opening of the
strain support. The
device may further comprise a strain support adhesive layer between the
strained elastic layer
and the strain support, wherein the strain support adhesive layer has a lower
T-peel force than the
skin adhesive layer. The strained elastic layer may be heat staked to the
strain support. The
strain support may further comprise perforations to facilitate separation of
the strain support
from the strained elastic layer.
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In another embodiment, a multi-layer tissue treatment device is provided,
comprising a
strained elastic base layer comprising a top surface, a bottom surface, a
perimeter edge and a
treatment opening, a skin adhesive layer adhered to the bottom surface of the
strained elastic
layer, a protective layer releasably contacting the skin adhesive layer, at
least one strained elastic
intermediate layer, wherein each elastic intermediate layer comprises a top
surface, a bottom
surface, a perimeter edge and a treatment opening aligned with the treatment
opening of the
strained elastic base layer, and wherein the bottom layer of one of the at
least one intermediate
elastic layer is attached to a top surface of the strained elastic base layer,
a strained elastic top
layer, comprising a top surface, a bottom surface, a perimeter edge and a
treatment opening,
wherein the treatment opening of the strained elastic top layer is aligned
with the treatment
opening of the strained elastic base layer, and the bottom surface of the
strained elastic top layer
is attached to the top surface of one of the at least one intermediate elastic
layer, and a strain
support releasably attached to at least one of the strained elastic top layer,
strained elastic bottom
layer, and the at least one elastic intermediate layer, wherein the strain
support is configured to
maintain the strain of the elastic base layer, the at least one intermediate
layer, and the elastic top
layer. The perimeter edge of the elastic top layer may be offset from the
perimeter edge of the
intermediate elastic layer that is attached to the elastic top layer, and
wherein the perimeter edge
of the elastic intermediate layer that is attached to the elastic base layer
may be offset from the
perimeter edge of the elastic base laver. The perimeter edge of the elastic
top layer may be offset
inward from the perimeter edge of the intermediate elastic layer that is
attached to the elastic top
layer, and wherein the perimeter edge of the elastic intermediate layer that
is attached to the
elastic base layer may be offset inward from the perimeter edge of the elastic
base layer. The
device of claim 8, wherein the bottom surface of the elastic top layer is
smaller than the top
surface of the intermediate elastic layer that is attached to the elastic top
layer, and wherein the
bottom surface of the elastic intermediate layer that is attached to the
elastic base layer is smaller
than the top surface of the elastic base layer. The bottom surface of the
elastic top layer may be
larger than the top surface of the intermediate elastic layer that is attached
to the elastic top layer,
and wherein the bottom surface of the elastic intermediate layer that may be
attached to the
elastic base layer is larger than the top surface of the elastic base layer.
The strained elastic top
layer, the strained elastic base layer, and each of the at least one elastic
intermediate layers, may
each have a different size. The elastic top layer may be smaller than all of
the at least one elastic
intermediate layers, and wherein all of the at least one elastic intermediate
layers may be smaller
than the elastic base layer. The elastic top layer may be larger than all of
the at least one elastic
intermediate layers, and wherein all of the at least one elastic intermediate
layers may be larger
than the elastic base layer. The at least one elastic intermediate layer may
comprise two elastic
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intermediate layers. The at least one elastic intermediate layer may comprise
two elastic
intermediate layers. The strained elastic top layer and the at least one
elastic intermediate layer
may each comprise a pull tab. The pull tab of the strained elastic top layer
and the pull tab of the
at least one elastic intermediate layer may each be a different size. The pull
tab of the elastic top
layer may be smaller than all of the pull tabs of the at least one elastic
intermediate layers. The
pull tab of the elastic top layer may be larger than all of the pull tabs of
the at least one elastic
intermediate layers. The strain support may be releasably attached to the top
surface of the
strained elastic top layer. The attachments of the top layer and the at least
one intermediate layer
may utilize anisotropic adhesive patterns. The anisotropic adhesive pattern
may have a reduced
amount of adhesive along a peel direction as compared to a strain direction of
the strained layers.
In another embodiment, a multi-layer tissue treatment device is provided,
comprising at
least two strained elastic layers, comprising at least a top elastic layer and
at least a base elastic
layer, wherein each of the at least two strained elastic layers comprises a
top surface, a bottom
surface, a size, a perimeter edge and a treatment opening, and wherein the at
least two strained
elastic layers are releasably attached together in a stacked configuration, a
skin adhesive layer
adhered to the bottom surface of the base elastic layer, a strain support
releasably attached to the
base elastic layer, wherein the strain support is configured to maintain the
strains of the at least
two strained elastic layers. A force per width level in the base elastic layer
may be higher than a
force per width level of any other of the at least two strained elastic
layers. The base elastic
layer may comprise at least 70% of a total force per width in the at least two
strained elastic
layers. The base elastic layer may comprise at least 90% of the total force
per width in the at
least two strained elastic layers. The base elastic layer may comprise a
higher durometer material
or a greater thickness than the other at least two strained elastic layers.
The at least two strained
elastic layers may further comprise at least one intermediate elastic layer,
located in the stacked
configuration between the top elastic layer and the base elastic layer. The
perimeter edge of each
of the at least two strained elastic layers may be offset from the perimeter
edge of an adjacent
strained elastic layer in the stacked configuration. The perimeter edge of
each of the at least two
strained elastic layers may be offset inward from the perimeter edge of an
adjacent higher
strained elastic layer in the stacked configuration. The perimeter edge of
each of the at least two
strained elastic layers may be offset outward from the perimeter edge of an
adjacent higher
strained elastic layer in the stacked configuration. The perimeter edge of
each of the at least two
strained elastic layers may be offset inward from the perimeter edge of an
adjacent lower
strained elastic layer in the stacked configuration. The size of each of the
at least two strained
elastic layers may be different. The size of each of the at least two strained
elastic layers may be
smaller than any adjacent lower strained elastic layer in the stacked
configuration. The size of
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each of the at least two strained elastic layers may be larger than an
adjacent higher strained
elastic layer in the stacked configuration. The size of each of the at least
two strained elastic
layers may be smaller than any adjacent higher strained elastic layer in the
stacked configuration.
The size of each of the at least two strained elastic layers may be larger
than an adjacent lower
strained elastic layer in the stacked configuration. The device of claim 35,
wherein at least one of
the at least two strained elastic layers comprises a pull tab. Each pull tab
of the at least one of at
least two strained elastic layers may comprise a different pull tab size. The
attachment of at least
two strained elastic layers may utilize an anisotropic adhesive pattern. The
attachments of the at
least two strained elastic layers may comprises adhesive layers therebetvveen
with a reduced
amount of adhesive along an orthogonal direction to a strain direction of the
strained layers. The
orthogonal direction is a peel direction of the at least two strained elastic
layers. The attachments
of the at least two strained elastic layers may comprises a thinner adhesive
layer than the skin
adhesive layer of the strained base layer.
In still another embodiment, a treatment device is provided, comprising a
strained elastic
layer comprising an upper surface, a lower surface and an opening
therebetvveen, a skin adhesive
on the lower surface of the strained elastic layer, an infusion hub located on
the upper surface of
the strained elastic layer, with a catheter or needle extending through the
opening of the strained
elastic layer, fluid tubing attached to the infusion hub and in fluid
communication with the
catheter or needle, a strain support configured to maintain the strain in the
strained elastic layer,
and at least one pull tab configured to releasably attach the strained elastic
layer and strain
support together. The treatment device may further comprise an infusion set
applicator that is
releasably attached to the infusion hub. The device may further comprise two
pull tabs located
on opposite sides of the strained elastic layer. Each of the two pull tabs may
comprise
perforations configured to tear and so that the strained elastic layer and
infusion hub can separate
from the strain support.
In another example, a treatment device is provided, comprising a strained
elastic layer
comprising an upper surface, a lower surface and an opening therebetween, a
skin adhesive on
the lower surface of the strained elastic layer, an infusion hub located on
the upper surface of the
strained elastic layer, with a catheter or needle extending through the
opening of the strained
elastic layer, fluid tubing attached to the infusion hub and in fluid
communication with the
catheter or needle, a strain support configured to maintain the strain in the
strained elastic layer,
and at least one pull tab configured to releasably attach the strained elastic
layer and strain
support together. The treatment device may further comprise an infusion set
applicator that is
releasably attached to the infusion hub. The device may comprises two pull
tabs located on
opposite sides of the strained elastic layer. Each of the two pull tabs may
comprise perforations
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configured to tear and so that the strained elastic layer and infusion hub can
separate from the
strain support.
In another example, a method for modulating tissue response at a target site
is provided,
comprising providing a strained elastic structure with an access opening and a
support structure,
placing the strained elastic structure against a target site, releasing the
strained elastic structure
from the support structure, and inserting an access structure into the target
site, wherein the
access structure is located in the access opening. The strained elastic
structure may be an elastic
sheet with an adhesive layer. Attaching the strained elastic structure to the
target site may
comprise adhering the strained elastic structure to a skin location. The
support structure may
comprise at least one pull tab, and releasing the strained elastic structure
from the support
structure may comprise actuating the pull tab to release the strained elastic
structure from the
support structure. The method may further comprise inserting the access
structure through the
access opening. The access structure may be a delivery tube, and wherein the
method further
comprises passing a sensor or infusion cannula using the delivery tube. The
access structure is
attached to a housing. The housing may comprise an adhesive. The housing may
further
comprise a support layer, and the adhesive is located on the inferior surface
of the support layer.
The method may further comprise adhering the housing to the elastic structure.
The method may
further comprise releasing the access structure from a delivery device after
inserting the access
structure into the target site. The method may further comprise aligning the
delivery device with
indicia or an alignment structure located on the strained elastic structure.
In another embodiment, a method of treating a therapeutic site is provided,
comprising
placing a first tensioning member at a first location next to a target site,
wherein the first
tensioning member is pre-tensioned along a first tensioning axis, placing a
second tensioning
member at a second location next to the target site, wherein the second
tensioning member is
pre-tensioned along a second tensioning axis and wherein the second location
is spaced apart
from the first location by a gap no greater than 20 mm and wherein the target
site is located in
the gap, and injecting or infusing a therapeutic agent at the target site. The
first tensioning axis
and the second tensioning axis may be parallel. The first tensioning member
and the second
tensioning member may be completely separate. The first and second tensioning
members may
be integrally formed with a predetermined longitudinal gap therebetween, the
longitudinal gap
comprising a longitudinal gap axis. The longitudinal gap axis may be located
between the first
and second tensioning axes. The longitudinal gap, the first tensioning axis
and the second
tensioning axis may each be parallel to each other. The predetermined
longitudinal gap has an
average of width of less than 20 mm, less than 10 mm, or less than 5 mm. The
method may
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further comprise adhering an infusion set to the first and second tensioning
members before
using the infusion set to infuse the therapeutic agent.
In another embodiment, a method of treating lipodystrophy is provided,
comprising
applying an adhesive skin tensioning device to an injection or infusion site
of a patient to reduce
the risk of lipodystrophy. The injection or infusion site may be an insulin or
insulin analogue
injection or infusion site. The patient may be diabetic and the lipodystrophy
may be
lipohypertrophy. The patient may have no prior history of lipohypertrophy, or
may have a prior
history of lipohypertrophy. The method may further comprise reducing the risk
of insulin
resistance, and/or reducing the rate of insulin or insulin analogue dosage
increase over a time
period. The time period may be one year.
In another embodiment, a method of treating diabetes is provided, comprising
applying an
adhesive skin tensioning device to an injection or infusion site of diabetes
patient to reduce the
rate of insulin or insulin analog dosage increase over time.
In still another embodiment, a method of treating diabetes may be provided,
comprising
applying an adhesive skin tensioning device to an injection or infusion site
of diabetes patient to
improve glucose time-in-range. The glucose time-in-range may be a daily,
weekly, or monthly
glucose time-in-range.
In another example, a method of reducing diabetes treatment costs in a
diabetic population
may be provided, comprising applying an adhesive skin tensioning device to an
insulin or insulin
analogue injection or infusion site of diabetes patient to reduce the costs of
blood glucose
variability or serious adverse events.
In still another example, a method of treating a therapy site is provided,
comprising
adhering a multi-layer strained dressing to a treatment site, releasing the
strain of the multi-layer
strained dressing to transfer strain from the dressing to the treatment site
to reduce tissue tension
at the treatment site, attaching a first hub and a first catheter to the multi-
layer dressing,
delivering a therapeutic agent through the first hub and first catheter to the
treatment site,
removing the first hub and first catheter from the multi-layer dressing by
removing a first layer
from the multi-layer dressing, attaching a second hub and a second catheter to
the multi-layer
dressing, delivering the therapeutic agent through the second hub and second
catheter to the
treatment site, removing the second hub and second catheter from the multi-
layer dressing by
removing a second layer from the multi-layer dressing.
In another embodiment, a method of positioning an infusion set is provided,
comprising
adhering a strained skin tension off-loading device to a treatment location,
wherein the skin
tension off-loading device comprises a strained elastic layer with a treatment
opening, a strain
support and a protruding alignment structure surrounding the treatment
opening, positioning an
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infusion set applicator over the treatment opening by using the alignment
structure, actuating the
infusion set applicator to decouple an infusion set hub from the infusion set
applicator and to
insert a catheter of the infusion set hub through the treatment opening,
removing the infusion set
applicator, and removing the strain support and protruding alignment structure
from the strained
skin tension off-loading device to release the strain in the strained elastic
layer. The method may
further comprise selecting the protruding alignment structure from a plurality
of different
protruding alignment structures and attaching the selected protruding
alignment structure to the
strain support. The protruding alignment structure may be integrally formed
with the strain
support.
According to some variations, the elastic device may be strained at different
strain values
during pre-conditioning.
In one embodiment, a method of treating subcutaneous tissue may be provided,
comprising
applying an adhesive skin tensioning device to a treatment site of a patient
to reduce the
development or progression of a subcutaneous lesion comprising calcifications,
cellular
proliferation or hypertrophy. The treatment site may be a device implantation,
injection or
infusion site. The subcutaneous lesion may be a lipodystrophy lesion. The
lipodystrophy lesion
may be a lipohypertrophy lesion. The injection or infusion site may be an
insulin or insulin
analogue injection or infusion site. The patient may be diabetic and the
subcutaneous lesion may
be lipohypertrophy. The patient may have no prior history of lipohypertrophy
or a prior history
of lipohypertrophy. The method may further comprise reducing the risk of
insulin resistance,
and/or reducing the rate of insulin or insulin analogue dosage increase over a
time period. The
time period may be one year. The infusion site may be a hemodialysis fistula
or graft site. The
injection site may be an oncologic therapy injection site. The oncology
therapy injection site may
be a pertuzumab and/or trastuzumab injection site. The treatment site may be
an implantation site
of an implantable pulse generator, implantable pacemaker or defibrillator. The
treatment site
may be an implantation site of a subcutaneous infusion port.
In another embodiment, a method of modifying drug pharmacokinetics is
provided,
comprising applying an adhesive skin tensioning device with a predetermined
tension to an
injection or infusion site of a therapeutic agent. The injection or infusion
may be performed
while the skin tensioning device activated at the injection or infusion site.
In still another embodiment, a method of treating diabetes is provided,
comprising
applying an adhesive skin tensioning device to an injection or infusion site
of diabetes patient to
improve or slow the progression of tissue stiffness in an injection or
infusion site.
In another embodiment, a method of treating diabetes is provided, comprising
applying an
adhesive skin tensioning device to an injection or infusion site to increase
the percentage of time-
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in-range of glycemic control. Time-in-range may be the percentage of time with
blood glucose
levels between 70 mg/di and 180 mg/d1.
In another variation, a method of treating diabetes is provided, comprising
applying an
adhesive skin tensioning device to an injection or infusion site to decrease
the percentage of time
in hypoglycemia. Hypoglycemia may be a blood glucose levels less than 70
mg/d1.
In another variations, a method of treating diabetes is provided, comprising
applying an
adhesive skin tensioning device to an injection or infusion site to decrease
the percentage of time
in hyperglycemia. Hyperglycemia may be a blood glucose levels greater than 180
mg/d1.
In still another variation, a method of treating diabetes is provided,
comprising applying an
adhesive skin tensioning device to an injection or infusion site of diabetes
patient to decrease
variability in insulin absorption compared to untreated controls. The decrease
in variability of
insulin absorption may be a decreased coefficient of variation of insulin
Cinax or AUCiNs as
measured by a hyperinsulinemic euglycemic clamp testing or mixed-meal
tolerance testing.
In another variation, a method of treating diabetes is provided, comprising
applying a
tissue tensioning device to an injection or infusion site of diabetes patient
to increase insulin
absorption compared to untreated controls. The increased insulin absorption
may be an increased
insulin cmax or AUCiNs as measured by a hyperinsulinemic euglycemic clamp
testing or mixed-
meal tolerance testing.
In another example, a system for treating chronic injection sites is provided,
comprising an
adhesive tensionable elastic dressing, the dressing comprising a first
attachment structure and a
second attachment structure, and at least one injection template, comprising a
plurality of
injection openings, a first attachment opening and a second attachment
opening, wherein the first
attachment structure may be configured to form a releasable interlock with the
first attachment
opening, and wherein the second attachment structure may be configured to form
a releasable
interlock with the second attachment opening. The adhesive tensionable
dressing may comprise a
plurality of dressing openings, wherein at least one dressing opening may be
aligned with each
of the injection openings of the plurality of openings of the at least one
injection template. The at
least one injection template may comprise one injection template, and wherein
each of the
dressing openings of the plurality of dressing openings may be aligned with an
injection opening
of the plurality of openings of the one injection template. The at least one
injection template
comprises a plurality of injection templates. The plurality of injection
templates consists of seven
injection templates. The plurality of injection openings of each injection
template of the plurality
of injection templates may comprise a different location from the other
injection templates of the
plurality of injection templates. The at least one injection template may
comprise one injection
template. The plurality of injection openings of the one injection template
may be arranged in a
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rectangular grid pattern. The plurality of injection openings of the one
injection template may be
arranged in a staggered grid pattern. A plurality of adhesive strips may be
removably coupled to
the plurality of injection openings. The number of the plurality of adhesive
strips may be lower
than a number of the plurality of injection openings. The number of the
plurality of injection
openings may be a three or four times multiple of the number of plurality of
adhesive strips. The
plurality of adhesive strips may be longitudinally aligned to a longitudinal
axis of the injection
template or transversely aligned to a transverse axis orthogonal to the
longitudinal axis of the
injection template. The plurality of adhesive strips may be parallel to each
other, and not parallel
to a longitudinal axis or transverse axis of the injection template. Each of
the plurality of
adhesive strips may extend beyond an edge of the injection template. The first
attachment
structure and the second attachment structures may have different shapes. The
first attachment
opening and the second attachment opening may have different shapes. The
system may further
comprising an applicator configured to maintain a predetermined tension in the
tensionable
tissue treatment device. The applicator may comprise a carrier sheet and
optionally a release
liner.
In another example, a system for treating chronic injection sites is provided,
comprising an
adhesive tensionable tissue treatment device comprising a plurality of
injection openings
surrounded by a plurality of removable adhesive rings, wherein the adhesive
rings have a lower
t-peel force than the adhesive tensionable tissue treatment device. The
plurality of injection
openings are arranged in a rectangular grid pattern. The system may further
comprise an
applicator configured to maintain a predetermined tension in the tensionable
tissue treatment
device.
In another variation, a method of treating injection sites is provided,
comprising adhering a
tensioned tissue treatment device to a skin surface, releasing some tension in
the tensioned tissue
treatment device to transfer tension force to the adhered skin surface,
attaching a first injection
template to the tensioned tissue treatment device, the first injection
template comprising a
plurality of needle insertion openings, inserting a first needle through a
first needle insertion
opening of the plurality of needle insertion openings, and detaching the first
injection template
from the tensioned tissue treatment device. The method may further comprise
removing a first
cover strip of the first injection template, wherein the first cover strip
surrounds or covers the
first needle opening. The method may also comprise reattaching the first
injection template to
the tensioned tissue device, inserting a second needle through a second needle
insertion opening
of the plurality of needle insertion openings, and detaching the first
injection template, wherein
the first cover strip also surrounds or covers the second needle insertion
opening. Removing the
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first cover strip may be performed before inserting the first needle through
the first needle
insertion opening.
In another embodiment, an injection guide system is provided, comprising a
plurality of
injection guides, each injection guide comprising at least one opening and an
adhesive lower
surface, and the plurality of injection guides in a separated configuration
with each injection
guide being spaced apart from the other injection guides, an adhesive carrier
sheet, the adhesive
carrier sheet maintaining the plurality of injection guides in a separated
configuration, and a
release liner, the release liner removably adhered to the adhesive lower
surfaces of the plurality
of injection guides. The system may further comprise a plurality of adhesive
injection guide
covers, the plurality of adhesive injection guide covers releasably adhered to
the plurality of
injection guides and located between the plurality of injection guides and the
adhesive carrier
sheet. The system may further comprise a dressing comprising a plurality of
dressing openings,
wherein the plurality of dressing openings are configured to be in alignment
with the at least
opening of each injection guide of the plurality of injection guides. The
plurality of injection
guides may comprise adhesive foam strips. The adhesive lower surface of each
injection guide
may have an adhesive property stronger than the adhesive carrier sheet. The
adhesive injection
guide covers may have a stronger adhesive property than the adhesive carrier
sheet. The adhesive
property of the adhesive lower surface of each injection guide may be stronger
than the adhesive
injection guide covers.
In another embodiment, a method of preparing a dressing may be provided,
comprising
aligning a plurality of separate injection guides to a plurality of dressing
openings on a dressing,
wherein each injection guide comprises multiple openings, and adhering the
plurality of separate
injection guides to the dressing. Adhering the plurality of separate injection
guides to the
plurality of dressing openings may be performed so that the multiple openings
of each injection
guide are aligned to the dressing openings. The method may further comprise
removing a release
liner from the plurality of separate injection guides. The method may further
comprise removing
a carrier sheet from the plurality of separate injection guides after adhering
the plurality of
separate injection guides to the dressing. Adhering the plurality of separate
injection guides to
the dressing may be performed so the adhering of the plurality of separate
injection guides is
performed simultaneously. Each injection guide of the plurality of separate
injection guides
further comprises a removable guide cover.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a variation of a dressing and packaging
assembly in a
closed configuration.
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FIG. 2 is a perspective view of the dressing and packaging assembly of FIG. 1
with a
cover open at about a ninety degree position from the closed position.
FIG. 3 is a bottom perspective view of the dressing and packaging assembly of
FIG. 1 with
a cover open at about a 360 degree configuration from the closed position.
FIG. 4 is a top perspective view of the dressing and packaging assembly of
FIG. 1 with a
cover open at about a 360 degree configuration from the closed position.
FIG. 5A is a schematic bottom view of the dressing and packaging assembly in
the position
illustrated in FIG. 3.
FIG. 5B is a cross section of FIG. 5A along the lines C-C.
FIG. 5C is a cross section of FIG. 5A along the lines D-D.
FIG. 6 illustrates a variation of a dressing and packaging assembly.
FIG. 7 is a perspective view of a dressing and packaging assembly with a cover
in an open
position 90 degrees from a closed position.
FIG. 8 is a schematic end view of the dressing and packaging assembly of FIG.
7 in a
strained configuration with the cover open at about 360 degrees from a closed
configuration.
FIG. 8A is an expanded view of section A of FIG. 8.
FIG. 8B is an expanded view of section B of FIG. 8.
FIG. 9 is a top perspective view of the dressing and packaging assembly of
FIG. 7 after
release.
FIG. 10 is a perspective view of another example of a dressing and packaging
assembly in
a closed configuration
FIG. 11 is a perspective view of the dressing and packaging assembly of FIG.
10 with a
cover in approximately 90 degree configuration from the closed configuration.
FIG. 12A is a top perspective view of the dressing and packaging assembly of
FIG. 10 with
a cover in approximately a 360 degree configuration from the closed
configuration.
FIG. 12B is a bottom perspective view of the dressing and packaging assembly
of FIG. 10
with a cover in approximately a 360 degree configuration from the closed
configuration.
FIG. 13 is a top view of a packaging device in an open configuration.
FIG. 14 is an exploded perspective view of a packaging device in an open
configuration.
FIG. 15A is a perspective view of a variation of dressing and packaging
assembly in an
unstrained configuration.
FIG. 15B is a bottom 15F perspective view of the dressing and packaging
assembly of
FIG. 15A in a strained configuration.
FIG. 15C is a bottom perspective view of the dressing and packaging assembly
of FIG. 15
A after removing the cover of the carrier, support or base.
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FIG. 15D is a top perspective view of the device of FIG. 15A after removing
the cover of
the carrier, support or base.
FIG. 15E is a top perspective view of the device of FIG. 15A after removing
the carrier,
support or base.
FIG. 15F is a perspective view of a strained dressing after it is separated
from the
attachment sheets.
FIG. 15G is a perspective view of a dressing assembly with attachment sheets.
FIG. 15H is a perspective view of the dressing assembly of FIG. 15G with an
attachment
sheet peeled back.
FIG. 151 is a perspective view of the dressing assembly of FIG. 15G with an
attachment
sheet removed.
FIG. 15J is a cross section of the dressing assembly with attachment sheets of
FIG. 15G.
FIG 16A is a perspective view of a variation of a dressing assembly with
removable
attachment sheets.
FIG. 16B is a perspective view of the dressing assembly of FIG. 16Avvith a
peeled
removable attachment sheet.
FIG. 16C is a perspective view of the dressing assembly of FIG. 16A with a
removed
attachment sheet.
FIG. 16D is a cross section of the dressing assembly with attachment sheets of
FIG. 16A
FIG. 17A is a perspective view of a variation of a dressing assembly with
removable
attachment sheets.
FIG. 17B is a perspective view of the dressing assembly of FIG. 17Avvith a
peeled
removable attachment sheet.
FIG. 17C is a perspective view of the dressing assembly of FIG. 17A with a
removed
attachment sheet.
FIG. 17D is a cross section of the dressing assembly with attachment sheets of
FIG. 17A.
FIG. 18A is a perspective view of a variation of dressing and packaging
assembly in an
unstrained configuration.
FIG. 18B is atop perspective view of the device of FIG. 18A in a strained and
folded
configuration.
FIG. 18C is a perspective view of the bottom side the device in the strained
and folded
configuration of FIG. 18B.
FIG. 18D is a top perspective view of the device of FIG. 18A in a strained and
folded
configuration while detaching an attachment sheet.
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FIG. 18E is a top perspective view of the device of FIG. 18A with a first side
of the
dressing assembly detached from the carrier and the cover removed.
FIG. 18F is a top perspective of the device of FIG. 18A with the dressing
assembly
detached from the carrier.
FIG. 18G is a top perspective view of the device of FIG. 18A with the carrier
detached and
removed.
FIG. 18H is a perspective view of the device of FIG. 18A with the dressing
being separated
from the attachment sheets.
FIG. 181 is a perspective view of the device of FIG. 18A with the dressing
separated from
the attachment sheets.
FIG. 18J is a side view of the device of FIG. 18A.
FIG. 19A is a perspective view of a variation of a dressing and packing
assembly device.
FIG. 19B is a top view of an unstrained configuration of a dressing assembly
of FIG. 19A
FIG. 19C is a top view of a strained and attached configuration of the
dressing assembly of
FIG. 19B.
FIG. 19D is a top view of a strained and detached configuration of the
dressing assembly
of FIG. 19B.
FIG. 19E is atop view of a dressing of FIG. 19B.
FIG. 20A is a top view of a variation of a dressing carrier, support, base
tensioning device
or applicator.
FIG. 20B is a side view of the dressing carrier, support, base tensioning
device or
applicator of FIG. 20A in a first configuration.
FIG. 20C is a side view of the dressing carrier, support, base tensioning
device or
applicator of FIG. 20A in a second configuration.
FIG. 21A is a perspective view of a variation of a dressing carrier, support,
base tensioning
device or applicator
FIG. 21B is a top view of the dressing carrier, support, base tensioning
device or applicator
of FIG. 21A.
FIG. 21C is aside view of dressing carrier, support, base tensioning device or
applicator of
FIG. 21A.
FIG. 21D is a top view of the dressing carrier, support, base tensioning
device or applicator
of FIG. 21A in a flexed configurationFIG. 21E is a cross-section of FIG. 21D
along the lines A-
A
FIG. 22A is a perspective view of a variation of a dressing and packaging
assembly in an
unstrained configuration.
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FIG. 22B is a perspective view of a variation of a dressing and packaging
device in a
strained configuration.
FIG. 23A is a top perspective view of the dressing assembly, support
structure, and
tensioning device in a relatively unstrained configuration.
FIG. 23B is a top perspective view of the dressing assembly, support
structure, and
tensioning device in a pre-strained configuration.
FIG. 23C is a schematic side view of the dressing assembly, support structure
and
tensioning device of FIG. 23B.
FIG. 23D is an enlarged schematic side sectional view of the dressing
assembly, support
structure, and tensioning device of FIG. 23C.
FIG. 23E is an enlarged, schematic, detailed side view of a portion of the
dressing and
support structure of FIG. 23D.
FIG. 23F is a schematic side view of the dressing assembly and support
structure in a pre-
strained configuration.
FIG. 23G is an enlarged side view of the dressing assembly and support
structure of
Section A of FIG. 23F
FIG. 23H is an enlarged side view of the dressing assembly and support
structure of
Section B of FIG. 23F.
FIG. 231 is a top perspective view of a pre-strained assembly including
remaining elements
of a dressing assembly and a support structure.
FIG. 24 is a perspective view of a plurality of pre-strained dressings on a
support element.
FIG. 25 illustrates a pre-strained dressing and support structure.
FIG. 26 illustrates the percent loss of force over time for elastic dressing
material as
describe in Example I.
FIG. 27 is a schematic illustration of percent force loss over time for a pre-
strained elastic
material component of a dressing.
FIG. 28 is a schematic illustration of tensile force over time for a pre-
strained elastic
material component of a dressing.
FIG. 29 illustrates the percent loss of force over time for elastic dressing
material as
describe in Example II.
FIGS. 30A to 30C depict the use of a strained dressing with an exemplary
infusion set.
FIG. 30D is a cross sectional view of the strained dressing and infusion set
in FIG. 30C.
FIGS. 31A to 31C depict the method of use of a strained dressing with an
infusion set
delivery device. FIGS. 31D and 31E are cross sectional views of the method of
use.
FIGS. 32A to 32E depict various exemplary aperture configurations for the
dressing.
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FIG. 33 depicts the placement of a three-aperture dressing onto an injection
location.
FIG. 34 depicts an exemplary dressing comprising an aperture and various
alignment
indicia.
FIG. 35 depicts the use of the exemplary dressing in FIG. 34 with a delivery
syringe.
FIG. 36 depicts the use of a dressing and a visual guide tool with the
delivery syringe.
FIG. 37A depicts another exemplary embodiment of a visual guide tool
comprising distal
opening and one or more inward projections. FIG. 37B depicts the visual guide
tool of FIG. 37A
overlaid on a dressing.
FIGS. 38A and 38B depict the use of the visual guide tool in FIGS. 37A and 37B
with an
infusion set delivery tool.
FIG. 39A is a perspective view of an exemplary infusion set delivery system
that includes
a pre-attached pre-strained dressing. FIG. 39B to 39D are top, side and bottom
views of the
system in FIG 39A. FIG 39E is a bottom view of the system with its adhesive
protective liners
removed.
FIG. 40A depicts the placement of the delivery system in FIG. 39E onto a
treatment site.
FIG. 40B depicts the infusion set and pre-attached dressing in FIG. 40A with
the pull tabs
removed. FIG. 40C depicts the infusion set in FIG. 40B with the dressing
support separated from
the dressing and withdrawal over the infusion set tubing. FIG. 40D depicts the
infusion set and
pre-attached dressing. FIG. 40E depicts the infusion set with the dressing
support comprising
tearable perforations.
FIG. 41A is a superior plan view of another embodiment of a combined infusion
set with a
multiple separable tensioning layers. FIG. 41B is a superior perspective view
of the embodiment
in FIG. 41A.
FIGS. 42A to 42C are superior perspective view of a method of using the
combined
infusion set and multiple tensioning layers depicted in FIGS. 41A and 41B.
FIGS. 43A to 43C are side elevational views of the method depicted in FIGS.
42A to 42C.
FIG. 44A is a detailed side elevational view of the method in FIGS. 42A; FIG.
44B is a
detailed view of the edges of the multiple tensioning layers in FIG. 44A.
FIG. 45A is a superior plan view of another embodiment of a combined infusion
set with a
multiple separable tensioning layers. FIG. 45B is a superior perspective
schematic view of the
embodiment in FIG. 45A.
FIGS. 46A to 46C are superior perspective view of a method of using the
combined
infusion set and multiple tensioning layers depicted in FIGS. 41A and 41B.
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FIGS. 47A and 47B are top and side elevational views of the method depicted in
FIGS.
46A to 46C. FIG. 47c is a detailed view of the edges of the multiple
tensioning layers in FIG.
47B.
FIGS. 48A and 48B are superior plan and inferior perspective views of another
exemplary
infusion set delivery system with a pre-attached radially pre-strained skin
tensioning device;
FIGS. 48C to 48E depicts the placement and release of the pre-strained skin
tensioning device.
FIGS. 49A to 49E are front perspective, superior plan, rear perspective, side
elevational
and inferior plan views, respectively, of a skin tensioning device with pre-
attached alignment
structure to facilitate placement of an infusion set delivery system.
FIGS. 50A to 50D depicts the use of the skin tensioning device in FIGS. 49A to
49E with
an infusion set delivery system.
FIG. 51 is a front perspective view of an alternate support structure for the
skin tensioning
device depicted in FIGS. 49A to 49E.
FIG. 52 is a schematic illustration of another exemplary embodiment of a skin
tensioning
system comprising two separate skin straining device placed on opposing sides
of an injection or
infusion site.
FIG. 53 is a schematic illustration of another exemplary embodiment of a skin
tensioning
system comprising interconnected lobes separated by a longitudinal gap or
slot.
FIGS. 54A and 54B are superior plan and side elevational views of an exemplary
infusion
hub and catheter with a pre-attached skin tensioning device.
FIG. 55A and 55B are schematic perspective views of a radially tensioned skin
treatment
device used for manual injection.
FIG. 56A is a superior perspective of a skin tensioning device with a woven
needle
injection aperture being used with a syringe. FIG. 56B is an inferior
perspective view of the skin
tensioning device in FIG. 56A.
FIG. 57A is a perspective view of an exemplary tensioned skin treatment system
comprising removable injection templates. FIGS. 57B to 57D depict different
injection
templates that are usable with the system in FIG. 57A.
FIG. 58 is a perspective view of another exemplary tensioned skin treatment
system
comprising a multi-day removable injection template
FIG. 59A is a perspective view of another exemplary tensioned skin treatment
system
comprising a weekly removable injection template with removable indicator
strips; FIGS. 59B to
59E depicts the serial removal of the indicator strips.
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FIG. 60A is a perspective view of another exemplary tensioned skin treatment
system
comprising removable injection templates. FIGS. 60B to 60D depict different
injection
templates that are usable with the system in FIG. 60A.
FIGS. 61A to 61D are top views of injection templates comprising a variable
alignment
structure.
FIG. 62A is a perspective view of another tensioned skin treatment system
comprising
removable rings. FIGS. 62B and 62C are perspective views of an additional skin
treatment
system comprising individual removable covers for each dressing opening. FIGS.
62D to 62G
depicts the use of the exemplary system in FIG. 628.
FIG. 63 is a perspective view of another tensioned skin treatment system.
FIG. 64A is a top view of another embodiment of a tensioned skin treatment
system
comprising removable strip ring markers. FIG. 64B is a top of the system in
FIG. 64A with one
strip ring marker removed.
FIG. 65A is a top plan view of another embodiment of a tensioned skin
treatment system,
comprising an adhesive set of injection guides and covers, with an applicator.
FIG. 65B is a
bottom plan view of the system in FIG. 65A, with the release liner removed.
FIG. 65C is an
exploded view of the system in FIG. 65A. FIG. 65D is an exploded view of the
system in FIG.
65B, with a dressing. FIG. 65E to 65G depicts the initial use of the system
adhered to a dressing.
FIG. 66A is a superior perspective view of an embodiment of a treatment
system, including
a dressing with an integrated, separable or removable infusion set. FIG. 66B
is a superior
perspective view of the system in FIG. 66A, with the infusion set connector
and tubing removed.
FIG. 66C is a superior perspective view of the system in FIG. 66A and 66B with
the infusion set
connector and tubing removed and the infusion hub and infusion catheter in the
process of being
removed. FIG. 66D is superior perspective view of the system in FIG. 66A to
66C, with the
infusion hub and infusion catheter removed from the dressing. FIG. 66E to 66H
are side views
depicting the use of the system to remove an infusion set from a dressing
while leaving the
dressing adhered to a subject. FIG 66E to FIG 66H correspond respectively to
FIG 66A to FIG
66D.
FIG. 67A is a superior perspective view of an embodiment of a treatment
system, including
a dressing with an integrated, separable or removeable infusion set. FIG. 67B
is a superior
perspective view of the system in FIG. 67A, showing the infusion set connector
and tubing as it
is removed. FIG. 67C is a superior perspective view of the system in FIG. 67A
and 67B showing
the infusion set hub and catheter as they are removed.
FIG 68A is an exploded superior perspective view of an embodiment of a
treatment system
including a dressing with an integrated separable or removeable infusion set.
FIGS 68B to 68F
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are superior perspective views illustrating steps of removing the infusion set
of FIG 68A from
the dressing.
FIG 69A is an exploded superior perspective view of an embodiment of a
treatment system
including a dressing with an integrated separable or removeable infusion set.
FIG. 69B is a
superior perspective view of the treatment system, of FIG 69A. FIG. 69C is a
superior
perspective view of the system in FIGS. 69A and 69B, with the infusion set
connector and tubing
being removed. FIG. 69D is a superior perspective view of the system in FIGS.
69A-69C, with
the infusion set connector and tubing removed and the infusion hub in a
secured position on
dressing connectors. FIG. 69E is a superior perspective view of the system in
FIGS. 69A-69D,
with the infusion hub rotated to an unsecured position and being removed from
dressing
connectors FIG 69F is a superior perspective view of the dressing and dressing
connector with
the infusion hub removed. FIG 69G is a superior view of an infusion hub
engaged with a
dressing connector. FIG 69H is a cross section of FIG 69G along the lines A-A.
FIG 691 is a
side view of an infusion hub engaged with a dressing connector. FIG 69J is a
partial cross
section inferior view of the infusion hub and dressing connector of FIG 691.
FIG. 69K is a side
cross sectional view of the infusion housing and hub.
FIG 70A is a side view of an embodiment of a treatment system including a
dressing with
an integrated separable or removable infusion set. FIG. 70B is a side view of
the treatment
system, of FIG 70A with the infusion set connector and tubing being removed.
FIG. 70C is a
superior perspective view of the system in FIGS. 70A and 70B with the infusion
set connector
and tubing removed. FIG. 70D is a superior perspective view of the system in
FIG 70C with a
removal tool. FIG 70E is a superior perspective view of the system of FIG 70D
with the removal
tool fully docked into the infusion hub. FIG 70G is a superior perspective
view of the dressing
and dressing connector with the infusion hub removed. FIG 70F is a superior
perspective cross
section of the system of Figure 70G. FIG 70H is a side cross section of the
system as shown in
FIG 70D. FIG 701 is a side cross section of the system as shown in FIG 70E.
FIG 70J is a side
cross section of the system as shown in FIG 70F. FIG 70K is a superior
perspective view of a
tool for removing a portion of an infusion set.
DETAILED DESCRIPTION
Previous attempts to treat scars and keloids have included surgery, silicone
dressings,
steroids, x-ray irradiation, and cryotherapy. Each of these techniques has
disadvantages.
Perhaps the biggest disadvantage is that none of them effectively prevent or
ameliorate the
formation of scars or keloids in the first instance. That is, these techniques
have primarily been
used to treat scars after they are already well established.
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Unloading of exogenous and/or endogenous stress in the vicinity of the wound
may
ameliorate the formation of scars, hypertrophic scars, or keloids. The
mechanical environment
of an injury may be an important factor in tissue response to that injury. The
mechanical
environment includes exogenous stress (i.e., physiological stress which
includes stress
transferred to the wound via muscle action or physical body movement) and
endogenous stress
(i.e., dermal stress originating from the physical properties of the skin
itself, including stress
induced at the wound site due to swelling or contraction of the skin). The
devices, dressings, kits
and methods described herein may control or regulate the mechanical
environment of a skin
including but not limited to the mechanical environment of a wound. The
devices, dressings,
kits and methods described herein may also control or regulate the mechanical
environment to
ameliorate scar and/or keloid formation. The mechanical environment of skin
may include
stress, strain, or any combination of stress and strain. The control of a
wound's mechanical
environment may be active or passive, dynamic (e.g., by applying an
oscillating stress) or static.
The stresses and strains acting on the wound may involve the layers of the
skin, such as the outer
stratum corneum, the epidermis and dermis, as well as the underlying
connective tissue layers,
such as the subcutaneous fat. Devices and methods described here may shield a
wound from its
mechanical environment. The term "shield" is meant to encompass the unloading
of stress
experienced by the wound as well as providing a physical barrier against
contact, contaminants,
and the like. The devices and methods described here may shield a wound by
unloading the
wound and surrounding tissues from endogenous stress and/or exogenous stress.
Thus, devices
and methods described here may reduce the stress experienced by a wound and
surrounding
tissues to a lower level than that experienced by normal skin and tissue.
Unloading of exogenous
and/or endogenous stress in the vicinity of the wound may ameliorate the
formation of scars,
hypertrophic scars, or keloids.
A cell's external mechanical environment may trigger biological responses
inside the cells
and change cell behavior. Cells can sense and respond to changes in their
mechanical
environment using integrin, an integral membrane protein in the plasma
membrane of cells, and
intracellular pathways. The intracellular pathways are initiated by receptors
attached to cell
membranes and the cell membrane that can sense mechanical forces. For example,
mechanical
forces can induce secretion of cytokines, chernokines, growth factors, and
other biologically
active compounds that can increase or trigger the inflammatory response. Such
secretions can
act in the cells that secrete them (intracrine), on the cells that secrete
them (autocrine), on cells
surrounding the cells that secrete them (paracrine), or act at a distance from
the point of secretion
(endocrine). Intracrine interference can alter cell signaling, which can in
turn alter cell behavior
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and biology including the recruitment of cells to the wound, proliferation of
cells at the wound,
and cell death in the wound. In addition, the extracellular matrix may be
affected.
As noted above, the wound healing process may be characterized in three
stages: early
inflammatory phase, the proliferative phase, and remodeling. The inflammatory
phase occurs
immediately after injury and typically lasts about two days to one week. Blood
clotting takes
place to halt blood loss and factors are released to attract cells that can
remove debris, bacteria
and damaged tissue from the wound. In addition, factors are released to
initiate the proliferative
phase of wound healing. In the proliferative phase, which lasts about four
days to several weeks,
fibroblasts grow and build a new extracellular matrix by secreting collagen
and proteoglycans.
At the end of the proliferative phase, fibroblasts can act to contract the
wound further. In the
remodeling phase, randomly oriented collagen is organized and crosslinked
along skin tension
lines. Cells that are no longer needed can undergo apoptosis. The remodeling
phase may
continue for many weeks or months, or indefinitely after injury. Scars
typically reach about 75-
80% of normal skin breaking strength about 6-8 weeks after injury. In general,
scars typically
have a triangular cross-section. That is, a scar is usually smallest in volume
near the skin surface
(i.e., stratum corneum and epidermis) and increases in volume as it progresses
into the deeper
layers of the dermis.
There are three common possible outcomes to a wound healing process. First, a
normal
scar can result. Second, a pathologic increase in scar formation can result,
such as formation of a
hypertrophic scar or a keloid. Third, the wound may not heal completely and
become a chronic
wound or ulcer. The devices, kits and methods described herein can ameliorate
the formation of
any type of scar. In addition, the devices, kits and methods described here
can be adapted for a
variety of wound sizes, and for different thicknesses of skin, e.g., the
devices may be configured
for use in different areas of the body. In addition, the devices, kits and
methods described here
can be adapted to ameliorate scar formation in any type of skin, e.g., body
location, age, race, or
condition.
Without wishing to be bound by any particular theory, we believe that
mechanical strain
acting on a wound or incision early in the proliferative phase of the wound
healing process may
inhibit cellular apoptosis, leading to a significant accumulation of cells and
matrix, and hence
increased scarring or the production of hypertrophic scars. Given the
underlying similarities
between hypertrophic scars and keloids with respect to excessive matrix
formation, we believe
that the devices and methods described herein may also be useful in preventing
and treating
keloids by offloading or neutralizing at least some of the strain that may be
acting on the wound
or incision. This tensile strain may be exogenous and/or endogenous strain,
and may include but
is not limited to the strain from the intrinsic tensile forces found in normal
intact skin tissue.
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A number of wound dressings have backings, adhesive liners and/or packaging
that are
removed prior to application of a wound dressing. Many existing dressings can
be clumsy to
orient and apply and can have a tendency to fold and adhere to themselves.
Devices, kits and methods described herein may treat skin at a skin site
("skin treatment
device-), including without limitation, to ameliorate the formation of scars
at wound sites by
controllably stressing or straining the epidermis and deeper layers of dermal
tissue at or near a
skin site, i.e., at or adjacent a wound or treatment site of a subject's skin,
thereby reducing tensile
or compressive stress at the skin site. The stress at the skin site may be
reduced to levels below
that experienced by normal skin and tissue. The stress or strain may be
applied to surrounding
tissue in one, two, or more directions to reduce endogenous or exogenous
stress at the skin site in
one, two or more directions. Thus, devices and methods described herein may
reduce the stress
experienced by skin and/or a wound and surrounding tissues in order to treat a
subject. The
device may also assist in preventing or reducing the incidence of wound
dehiscence.
Devices, kits and methods described herein may provide a packaging and/or
applicator for
a dressing. According to one variation, the packaging and/or applicator is
configured to provide
quick or easy preparation and/or application of a dressing. While some
examples herein
specifically refer to a packaging that also acts as a tensioning device to pre-
strain a dressing,
other dressings that are not pre-strained and/or strained prior to application
may be provided in
accordance with one or more variations or embodiments. The packaging may also
operate as an
applicator where one or more elements of the packaging may be used to position
and/or apply
the dressing to the skin of a subject.
Devices kits and methods described herein may be for the preparation and/or
application of
a dressing. Such preparation may include but is not limited to, for example,
removal of an
adhesive liner, straining or tensioning a dressing, orienting a dressing for
application and/or
applying a medicament or other material to a portion of the dressing prior to
application.
Backings, adhesive liners or release layers, and/or other packaging may
provide some
structural stability to a flexible wound dressing. However, when removed, the
flexible wound
dressing can be somewhat clumsy to use because it may fold and adhere to
itself or the user, or
otherwise provide for difficult positioning over the wound. Also the act of
pulling or removing
the liner and reorienting the dressing to the patient may increase the
tendency to fold or flop.
Furthermore, because of the folding or floppiness of the dressing, during
adhesive removal and
subsequent reorientation, the user has a significant possibility of
compromising the sterility of a
portion of the device to be applied to a wound site.
According to another variation, a packaging or applicator is configured to
provide support
for the dressing after the dressing is prepared and while the dressing is
applied to a subject.
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According to some variations, a backing provides structural support or
stability of the dressing as
and/or after an adhesive liner is released. According to some variations, a
dressing and
packaging is configured to be pre-oriented in a position facing a wound .i.e.,
for immediate
application when and after the wound device is prepared for application.
According to some
variations, the packaging applicator is configured to be used with one hand to
orient and/or apply
the device to the skin of a subject.
According to some variations, the packaging dressing carrier, support, base
tensioning
device or applicator tensioning device and/or applicator provide a release
mechanism to separate
the applied dressing from the packaging and/or applicator after the dressing
is applied to the
skin. According to a variation, a dressing may be prestrained and coupled to a
dressing carrier,
support, base tensioning device or applicator, for example as set forth in
U.S. Provisional
Application serial no. 61/512,340 filed on July 17, 2011 and incorporated in
its entirety herein by
reference. One or more dressing releases described herein may be used with a
dressing carrier,
support, base tensioning device or applicator.
In some further variations, the dressing or one or more adhesive regions of
the dressing
may be released, i.e., separated, from the liner by opening a packaging or
applicator. According
to some variations, a book-like packaging is provided with a cover, and a base
to which a
dressing is removably attached. When or as the cover is opened, the liner may
be manually or
automatically released from the adhesive of the dressing. According to
variations, a liner is
attached to the cover and will expose an adhesive side of a dressing when the
cover is lifted or
opened. The base may be configured to provide structural support to the
dressing while the liner
is removed and/or while the dressing is applied to the skin of a subject.
According to some variations, the packaging, tensioning device, dressing
carrier, support,
base or applicator may further comprise an opening, a window, or a clear or
semi-opaque portion
through which a wound, incision or other location may be visualized as the
dressing is applied to
the skin. According to some variations, the window guides the application of a
dressing so that
there is an optimal or desired distance between the wound and the edges of the
dressing and/or so
that the dressing is in an optimal location for unloading skin stresses.
According to some variations the applicator, tensioning device, packaging or
carrier,
support, or base may provide varied or variable flexibility to allow the
dressing to be shaped
when applied to various body locations or contours.
According to some variations, a packaging or applicator is more rigid or
provides
sufficient column strength in at least a first direction to be supportive of a
dressing, while being
relatively more flexible and less rigid in at least second direction to
provide for a more
conforming application to a curved or shaped skin surface of a subject or to
permit curvature or
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shaping of the dressing where it is applied. The first and second directions
may or may not be
orthogonal to each other. According to some variations, a packaging
applicator, tensioning
device or dressing carrier, support or base is sufficiently rigid or
supportive of a dressing while
permitting shaping of the dressing, According to some variations, the carrier
or support which
may include a base and/ or a cover may comprise segments of relatively more
rigid material
flexibly coupled to adjacent segments to provide flexibility to permit shaping
of
packaging/applicator and/or dressing while providing sufficient support of the
dressing during
application. According to some variations, segments are coupled to adjacent
segments by way of
a flexible material, such as a low-density polyethylene (LDPE) material, or a
composite of
adhesive and a thinner more flexible substrate. Alternatively, segments may be
formed as a
structure by manufacturing a substrate with cut-outs, slots, grooves, scoring
or other openings or
variations in thickness of the substrate at different locations.
The packaging, applicator, tensioning device, or dressing carrier may have
elements or
features the provide flexibility in one direction orthogonal to the plane of
the support while
limiting flexibility in another direction orthogonal to the plane of the
support. According to
some variations, the flexible elements may limit flexibility when the device
is being strained and
permit flexibility when the device is being applied to the skin. Each of the
elements may permit
flexing in a different direction than one or more of the other elements.
Flexible elements may be
straight, or shaped according to a desired application or location of
placement.
According to variations, flexible elements are provided in combination with
support
elements that provide sufficient support to allow a user to maintain the
dressing in a strained
configuration. According to variations, one or more elements may be provided
to maintain a
strained dressing in a strained configuration, for example a securing element
that secures the
dressing in a strained configuration until it is applied to a subject and is
released from the carrier,
support, base tensioning device or applicator. For example, after straining
the dressing, the
dressing may be adhered or attached to one or more elements of a dressing,
support, base
tensioning device or applicator or dressing assembly until it is released from
the carrier, support,
base tensioning device or applicator or assembly.
According to some variations, the applicator may be further used to help
reduce bleeding,
e.g., by allowing application of a compressive force using a support structure
while or after the
device is applied. One or more hemostatic or coagulative agents may be applied
to, or otherwise
integrated with dressing to help reduce bleeding. Potential agents include
chitosan, calcium-
loaded zeolite, microfibrillar collagen, cellulose, anhydrous aluminum
sulfate, silver nitrate,
potassium alum, titanium oxide, fibrinogen, epinephrine, calcium alginate,
poly-N-acetyl
glucosamine, thrombin, coagulation factor(s) (e.g. II, VII, VII, X, XIII, Von
Willebrand factor),
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procoagulants (e.g. propyl gallate), antifibrinolytics (e.g. epsilon
aminocaproic acid), and the
like. In some variations, the agents may be freeze-dried and integrated into
the dressing and
activated upon contact with blood or other fluid. In some further variations,
an activating agent
may be applied to the dressing or the treatment site before the dressing is
used on the subject. In
still other examples, the hemostatic agent may be applied separately and
directly to the wound
before application of the dressing, or after application to the dressing via a
catheter or tube. The
devices may also comprise one or more other active agents that may be useful
in aiding in some
aspect of the wound healing process. For example, the active agent may be a
pharmaceutical
compound, a protein (e.g., a growth factor), a vitamin (e.g., vitamin E), or
combinations thereof
A further example of such medicament may include, but is not limited to
various antibiotics
(including but not limited to cephalosporins, bacitracin, polyxyxin B sulfate,
neomycin,
polysporin), antiseptics (such as iodine solutions, silver sulfadiazine,
chlorhexidine), antifungals
(such as nystatin), antiproliferative agents (sirolimus, tacrolimus,
zotarolimus, biolimus,
paclitaxel), grow factors (such as VEGF) and other treatments (e.g. botulism
toxin. Of course,
the devices may comprise more than one medicament or agent, and the devices
may deliver one
or more medicaments or agents.
According to one variation, the applicator and or packaging may be
sufficiently supportive
or rigid to hold a dressing's form so that it is easy to manipulate. According
to a variation, the
applicator may be sufficiently wider and/or longer or have a sufficiently
larger area than a
dressing so that it may provide sterile application and/or one-handed
application. According to
variations, a support structure is provided for a dressing. According to a
variation, a margin is
provided as a support structure between the dressing or dressing adhesive and
one or more edge
portions of the support structure. Such margins provide a supported edge or
area to grasp or
manipulate the dressing or its carrier, base or support, without necessitating
or creating a greater
likelihood of inadvertent user contact with the adhesive.
According to some variations, the packaging or applicator may also be used to
strain a
dressing prior to application to provide a dressing configured to ameliorate
scar or keloid
formation.
Devices are described here that may be used for ameliorating the formation of
scars and/or
keloids at a skin or wound site. The scars may be any type of scar, e.g., a
normal scar, a
hypertrophic scar, etc. In general, the devices may be configured to be
removably secured to a
skin surface near a wound. The devices may shield the skin or wound from
endogenous stress
and/or exogenous stress. In some variations, the devices may shield the skin
or wound from
endogenous stress without affecting exogenous stress on the skin or wound,
e.g., devices that
modify the elastic properties of the skin, etc. In other variations, the
devices may shield the skin
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or wound from exogenous stress without affecting endogenous stress on the
wound. Such
variations may include situations where the musculature and surrounding skin
or wound tissue
has been paralyzed, e.g., through the use of botulinum toxin or the like. In
still other variations,
the devices shield the skin or wound from both endogenous and exogenous
stress.
The devices or dressings described herein may treat skin at a skin site
including without
limitation to ameliorate the formation of scars at wound sites by controllably
stressing or
straining the epidermis and deeper layers of dermal tissue at or near a skin
site, thereby reducing
tensile or compressive stress at the skin site itself The stress at the skin
site may be reduced to
levels below that experienced by normal skin and tissue. The stress or strain
may be applied to
surrounding tissue in one, two, or three directions to reduce endogenous or
exogenous stress at
the skin site in one, two or three directions. The physical characteristics of
the dressing and/or
the method of applying the dressing may also be further configured to resist
or reduce the rate of
skin stripping or tension blistering from the application of strain to the
incision site. For example,
the stretching of the adhesive regions when applied to the skin surface may
result in an increased
tissue density under the adhesive region. This may be the result of generally
planar, tangential or
parallel compression of skin tissue that is directly attached to that adhesive
region, resulting from
the relaxation of the adhesive region. In some examples, this tissue
compression may reduce the
risk of tissue stripping and/or blistering of skin in direct contact with the
adhesive, in contrast to
bandage "strapping" where one end of a bandage is adhered to the skin and then
tensioned or
pulled across a wound before the other end is attached to the skin on the
opposite side of the
wound. Bandage "strapping", while generating tension in the bandage during the
application,
may simultaneously generate a relatively high tissue strain at the first
adhesion site. This high
tissue strain then decreases when the bandage is attached to the skin at a
second adhesion site as
the high peak stresses are redistributed along the skin under the bandage. In
contrast, when a
pre-strained bandage is applied to the skin, little if any strain may be
transferred or generated in
the skin as the adhesive regions are applied to the desired locations. When
the pre-strained
bandage is permitted to relax, however, the strain (or peak strain) in the
skin may be increased.
Thus, with a pre-strained bandage, temporary high tissue strain may be avoided
or otherwise
reduced during the application procedure. In other variations, however, the
dressing may also be
applied to the skin by strapping, or by a combination of pre-straining and
strapping.
The dressing may comprise an elastic member, such as a sheet of elastic
material. The
elastic material of the dressing may comprise a single layer of material or
multiple layers of the
same or different materials. The material may have any of a variety of
configurations, including
a solid, foam, lattice, or woven configuration. The elastic material may be a
biocompatible
polymer, e.g., silicone, polyurethane, TPE (thermoplastic elastomers),
synthetic rubber or co-
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polyester material. The thickness of polymer sheets may be selected to provide
the dressings
with sufficient load carrying capacity to achieve desired recoverable strains,
and to prevent
undesired amounts of creep deformation of the dressings over time. In some
variations, the
thickness across dressings is not uniform, e.g., the thickness across the
dressing may be varied to
change the stiffness, the load carrying capacity, or recovery strains in
selected orientations and/or
locations. The elastic material of the exemplary dressing may have a thickness
in the range of
about 50 microns to 1 mm or more, about 100 microns to about 500 microns,
about 120 microns
to about 300 microns, or in some variations about 200 microns to about 260
microns. The
exemplary dressings have an edge thickness of about 500 microns or less, 400
microns or less, or
about 300 microns or less may exhibit less risk of skin separation from
inadvertent lifting when
inadvertently brushed against clothing or objects. In some variations, the
dressings are tapered
near the edges to reduce thickness. A tapered edge may also ameliorate peak
tensile forces
acting on skin tissue adjacent to the adhesive edges of the dressing. This may
or may not reduce
the risk of skin blistering or other tension-related skin trauma. In other
variations, the edges of
the dressing may be thicker than the middle of the dressing. It is
hypothesized that in some
configurations, a thicker dressing edge may provide a relative inward shift of
the location of the
peak tensile forces acting near the dressing edge, compared to dressings of
uniform thickness.
The elastic material may have a load per width of at least 0.35 Newtons per mm
at an
engineering strain of 60% or a load per width of at least 0.25 Newtons per mm
at an engineering
strain of 45%. The elastic material may have a load per width of no greater
than about 2
Newtons per mm at the engineering strain of about 45% to 60%, about 1 Newtons
per mm at the
engineering strain of about 45% to 60%, about 0.7 Newtons per mm at the
engineering strain of
about 45% to 60%, or no greater than about 0.5 Newtons per mm at the
engineering strain of
about 45% to 60%. The system elastic material may have a load per width that
does not decrease
from an engineering strain of 0% to 60%, a load per width plot that increases
linearly from an
engineering strain of 0% to 60%, or a load per width plot that is not convex
from an engineering
strain of 0% to 60%. The elastic material may comprise an adhesive configured
to maintain a
substantially constant stress in the range of 200 kPa to about 500 kPa for at
least 8 hours when
strained to an engineering strain of about 20% to 30% and attached to a
surface. The elastic
material may comprise an adhesive configured to maintain a substantially
constant stress in the
range of 200 kPa to about 400 kPa for at least 8 hours when strained to an
engineering strain of
about 20% to 30% and attached to a surface. The substantially constant stress
may vary by less
than 10% over at least 8 hours, or by less than 5% over at least 8 hours.
Although the depicted dressings may have a generally rectangular configuration
with a
length and/or width of about 160 mm to about 60 mm, in other variations the
dressing may have
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any of a variety of lengths and widths, and may comprise any of a variety of
other shapes. Also,
the corners of the dressing may be squared or rounded, for example. The
lengths and/or widths
of an exemplary dressing may be in the range of about 5 mm to about 1 meter or
more, in some
variations about 20 mm to about 500 mm, and in other variations about 30 mm to
about 50 mm,
and in still other variations about 50 mm to about 100 mm. In some variations,
the ratio of the
maximum dimension of the dressing (e.g. its length) to an orthogonal dimension
to the maximum
dimension (e.g. width), excluding the minimum dimension of the dressing (e.g.
the thickness),
may be in the range of about 1:3, about 1:2, about 1:1, about 2:1, about 3:1,
about 4:1 about 5:1,
about 6:1, about 7:1, about 8:1, about 9:1 or about 10:1 or greater. In some
variations, the strain
axis of the dressing in use may be oriented with respect to the maximum
dimension or to the
orthogonal dimension to the maximum dimension. In some variations, the final
compressive
stress and strain imposed onto the skin by the elastic material may be the
result of the dynamic
equilibrium between the tensile stress in the skin and the elastic material of
the dressing. The
skin at the skin site typically comprises an inherent tension that stretches
incision site, whether or
not any tissue was excised from the skin site. The elastic material and the
adhesive region may
be configured to be applied to a skin location so that when the dressing is
stretched to a
particular tension and then adhered to the incision site, tensile stress in
the dressing is transferred
to the incision site to compress the tissue directly under the dressing along
a tangential axis to the
skin surface, the stress and strain imposed onto the skin location has a net
or resultant orientation
or axis is also generally tangential or planar to the elastic material and/or
the outer surface of the
skin location, with a similar axis to the orientation or axis of the tensile
stress in the dressing.
The tension in the dressing will relax to a tension level that maintains
equilibrium with increased
tension in the skin adjacent to the dressing. The application of the dressing
to the skin location
may involve the placement of the dressing without overlapping or being wrapped
onto itself, e.g.
wherein only adjacent regions of the dressing are interconnected and wherein
non-adjacent
regions of the dressing are not interconnected. The actual amount of stress
and strain imposed
on the skin may vary, depending upon the particular person, skin location, the
thickness or
various mechanical characteristics of the skin layers (e.g. epidermis, dermis,
or underlying
connective tissues), and/or the degree of pre-existing scarring, for example.
In some further
variations, the wound treatment dressing may be selected or configured for use
at a specific body
location, such as the scalp, forehead, cheek, neck, upper back, lower back,
abdominal region,
upper torso (including but not limited to the breast folds), shoulder, upper
arm, lower arm, palm
regions, the dorsum of the hand, finger, thigh, lower leg, the dorsum or
plantar surface of the
foot, and/or toe. Where applicable, some body regions may be further
delineated into anterior,
posterior, medial, lateral, proximal and/or distal regions, e.g. the arms and
legs.
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The dressing may be configured to impose a skin strain in the range of about
10% to about
60% or more, in other configurations about 15% to about 50%, and in still
other configurations,
about 20% to about 30% or about 40%. To achieve the desired degree of skin
strain, the
dressing may be configured to undergo elastic tensile strain in the range of
about 20% to about
80% or more, sometimes about 30% to about 60%, and other times about 40% to
about 50% or
about 60%. The dressing may comprise any of a variety of elastic materials,
including but not
limited to silicones, styrenic block copolymers, natural rubbers,
fluoroelastomers,
perfluoroelastomers, polyether block amides, thermoplastic elastomers,
thermoplastic
polyurethane, polyisoprene, polybutadiene, and the like. The material of the
exemplary dressing
may have a Shore A durometer in the range of about 20 to about 90, about 30 to
about 80, about
50 to about 80. The exemplary dressing was constructed of MED 82-5010-05 by
NUSIL
TECHNOLOGY LLC (Carpinteria, CA). Other examples of suitable materials are
described in
U.S. Appin. No. 11/888,978, which was previously incorporated by reference in
its entirety.
When the dressing is applied to a skin location and allowed to at least
partially recover to
its base configuration, the recovery level or equilibrium level of strain in
the dressing may be in
the range of about 4% to about 60% or more, in other configurations about 15%
to about 50%,
and in still other configurations, about 20% to about 30% or about 40%. The
ratio between the
initial engineering tensile strain placed onto the dressing before recovery
and the resulting
engineering compressive strain in the skin may vary depending upon the skin
type and location,
but in some examples, may be about 2:1. In other examples, the ratio may be in
the range of
about 4:1 to about 5:4, about 3:1 to about 5:3, or about 5:2 to about 2:1.
These skin strain
characteristics may be determined with respect to a reference position of the
body or body part,
e.g. anatomical position, to facilitate reproducible measurements. The
particular degree of strain
may be characterized as either an engineering strain or a true strain, but may
or may not be
calculated based upon or converted from the other type of strain (e.g. the
strain may be based
upon a 45% engineering strain that is converted to a true strain).
In some further variations, one or more characteristics of the elastic
material may
correspond to various features on the stress/strain curve of the material. For
example, the
engineering and true stress/strain curves for one specific example of the
dressing comprises a
material that exhibits an engineering stress of about 1.2 MPa at about 60%
engineering strain,
but in other examples, the engineering stress may be in the range of about
900KPa to about
3.5MPa, about 1MPa to about 2.2MPa, about 1 MPa to about 2MPa, about 1.1 MPa
to about 1.8
MPa, about 1.1MPa to about 1.5 MPa, about 1.2 MPa to about 1.4 MPa. When
unloading or
relieving stress from the dressing, the material may be configured with an
engineering stress of
about 380 KPa at about 40% engineering strain, but in other examples, the
engineering stress
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during unloading of the material to about a 40% strain may be in the range of
about 300 KPa to
about 700 KPa, about 325 KPa to about 600 KPa, about 350 KPa to about 500KPa,
or about 375
KPA to about 425 KPa. When unloading the material to an engineering strain of
about 30%, the
material exhibits an engineering stress of about 300 KPa, but in other
examples, the engineering
stress when unloading the material to about 30% strain may be in the range of
about 250 KPa to
about 500 KPa, about 275 KPa to about 450 KPa, about 300 KPa to about 400KPa,
or about 325
KPA to about 375 KPa. When unloading to an engineering strain of about 20%,
the material
may have an engineering stress of about 100 KPa, but in other examples, the
unloading
engineering stress at about 20% may be in the range of about 50 KPa to about
200 KPa, about 75
KPa to about 150 KPa, or about 100 KPa to about 125KPa. In some examples, the
material may
be configured to at least achieve a specific range or level of engineering
stress at each of the
specified engineering strain levels described above, but in other examples,
the material may be
configured for lower levels of maximum engineering strain, e.g up to about 30%
or about 40%.
In some examples, certain portions of the stress/strain curve may have a
particular
morphology. For example, for a particular level of maximum strain the loading
curve may be
generally linear on the corresponding true stress/strain curve. In an example
using a dressing
described herein, up to a true strain of about 45%, the loading curve had a
generally linear
configuration. In other examples, the configuration may only be linear along a
portion of the
loading curve or may be curved along the entire loading curve. Where the
loading curve is non-
linear, the loading curve may be convex, concave or both. Also, in some
examples, the tangent
line of the loading curve (i.e. the line between the two triangles) may also
be generally co-linear.
In some variations, the elastic material comprises a material having an
elastic modulus E of
at least about 1 MPa, about 1.5 MPa, about 2 MPa, about 2.5 MPa, about 3 MPa,
about 3.5 MPa,
about 4 MPa, about 5 MPa, about 6 MPa, about 7 MPa, about 8 MPa, about 9 MPa
or at least
about 10 MPa or greater. The material elastic modulus E may be no greater than
about 10 MPa,
about 9 MPa, about 8 MPA, about 7 MPa, about 6 MPa, or about 5 MPa, or about 4
MPa.
In addition to the absolute stress levels at certain strain levels described
above, the material
may also be characterized with respect to the ratio between a) the stress to
achieve a particular
strain during loading, and b) the stress at the same strain during unloading.
For example, the
material may have a ratio of at least 4:1 to about 3:2 at each of the 20%, 30%
and 40% strain
levels, but in other examples, the material may exhibit these ratios only at
20%, at 30%, or at
40% strain levels, or at both 20% and 30% but not 40%, or at both 30% and 40%
but not 20%.
In other examples, the ratio at one, some or all of the strain levels may be
in the range of about
3:1 to about 2:1, or about 5:2 to about 2:1.
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In some examples, the elastic material of the dressing may be configured under
testing
conditions to achieve a stable level of stress at a constant strain, e.g. the
material exhibits a
limited amount of stress relaxation over a particular period of time and at a
particular level of
strain. The period of time may be at least about 8 hours, about 12 hours,
about 18 hours, about
24 hours, about 36 hours, about 48 hours, about 72 hours, about 4 days, about
5 days, about 6
days, or about a week or more. The level of strain may be about 10%, about
20%, about 30%,
about 40%, about 50%, about 60%, about 70%, or about 80% or more. The stress
of the
exemplary dressing over various time curves may be configured to maintain an
engineering
stress of about 300 KPa at an engineering strain of about 30% without
noticeable deviation over
a period of about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 5
hours, about 6
hours, about 7 hours, or about 8 hours or more. The stresses at 10% strain,
20% strain, and at
40% may be lower or higher.
In some variations, the elastic material or the dressing may be configured
under testing
conditions to maintain a particular minimum level of stress when held at a
constant strain over a
particular time period. In an example to assess the ability of a backing
material to maintain a
stress and strain on skin over time, engineering strains were measured while
each backing
material was tensile strained to 60% at a rate of 100 microns per second and
held for 10 minutes,
and then dropped to a strain of 30% at a rate of 100 microns per second and
held for 9 hours.
For example, the exemplary dressing is able to maintain an engineering stress
level of about 350
KPa at an engineering strain of 30%. In some other examples, the minimum level
of stress may
be about 100 KPa, about 120 KPa, about 140 KPa, about 160 KPa, about 180 KPa,
about 200
KPa, about 220 KPa, about 240 KPa, about 260 KPa, about 280 KPa, about 300
KPa, about 320
KPa, about 340 KPa, about 360 KPa, about 380 KPa, about 400 KPa, about 420
KPa, about 440
KPa, about 460 KPa, about 480 KPa, about 500 KPa, about 600 KPa, about 700
KPa, about 800
KPa, about 900 KPa or about 1000 KPa or greater. The level of constant strain
may be different
in other configuration, with a level of about 15%, about 20%, about 25%, about
30%, about
35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about
70%, about
75%, or about 80%. The time period over which the dressing is able to maintain
a stress level
may be at least about 2000 seconds, about 3000 seconds, about 4000 seconds,
about 5000
seconds, about 6000 seconds, about 7000 seconds, about 8000 seconds, about
9000 seconds,
about 10000 seconds, about 20000 seconds, about 30000 seconds, about 40000
seconds, about
50000 seconds, about 60000 seconds, about 70000 seconds, about 24 hours, about
36 hours,
about 48 hours, about 72 hours, about 4 days, about 5 days, about 6 days,
about 7 days, about 10
days, about 2 weeks, about 1 month or more. In some variations, the dressing,
the elastic
material and/or the adhesive material is configured to exhibit less than about
a 15% change in
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stress or strain level over the particular period when applied to a skin
surface or test surface. In
other examples, the degree of change may be about 12%, about 10%, about 8%,
about 6%, about
5%, about 4%, about 3%, or about 2% or less. The stress or strain may be an
engineering stress
or strain, and/or a true stress or strain.
The adhesive used may be, for example, a pressure activated adhesive (PSA), as
a silicone,
acrylic, styrene block copolymer, vinyl ether, nitrile or other PSA. In other
variations, a non-
pressure sensitive adhesive may be used, including but not limited a heat or
light-cured adhesive.
The pressure sensitive adhesive may be made from, e.g., polyacrylate-based,
polyisobutylene-
based, silicone-based pressure sensitive adhesives, synthetic rubber, acrylic,
and polyisobutylene
(PIB), hydrocolloid, and the like. The T-peel release force and blunt probe
tack force of the
adhesive may be measured by a standardized test method, such as ASTM D1876 and
ASTMD2979 or other appropriate method. In some variations, the T-peel release
force or blunt
probe tack test value of the adhesive is configured to maintain loads of at
least about 50 mPa/mm
for at least about 24 hours, about 48 hours, about 72 hours, about 1 week,
about 2 weeks, about 3
weeks, about 4 weeks or more. In other variations, the loads may be at least
about 75 mPa/mm,
about 100 mPa/mm, about 125 mPa/mm, or at least about 150 mPa/mm over the
particular time
period. The degree of adhesion (e.g. as measured by the T-peel release force
or blunt probe tack
test value) may vary depending upon the degree of strain placed onto the skin
or incision site,
and in some variations, these time periods may be based upon an average skin
strain of about
10%, about 20%, about 30%, about 40%, or about 50% or more. In some
variations, the
adhesive may have a T-peel release force of at least about 150 kg/m, about 160
kg/m, about 170
kg/m, about 180 kg/m, about 190 kg/m, about 200 kg/m, about 210 kg/m, about
220 kg/m, about
230 kg/m, about 240 kg/m, about 250 kg/m, about 260 kg/m, about 270 kg/m,
about 280 kg/m,
about 290 kg/m, about 300 kg/m, about 310 kg/m, about 320 kg/m, about 330
kg/m, about 340
kg/m, about 350 kg/m, about 400 kg/m, about 450 kg/m, or at least about 500
kg/m or higher. In
some further variations, the T-peel release force may be no greater than about
1000 kg/m, about
900 kg/m, about 800 kg/m, about 700 kg/m, about 600 kg/m, about 500 kg/m,
about 400 kg/m or
about 300 kg/m. The blunt probe tack test value of the adhesive may be at
least about 0.50 kg,
about 0.55 kg, about 0.60 kg, about 0.65 kg, about 0.70 kg or about 0.75 kg or
higher, and may
be no greater than about 1 kg, about 0.9 kg, about 0.8 kg, about 0.7 kg, or
about 0.6 kg. The T-
peel release force and blunt probe tack force may be measured by a
standardized test method,
such as ASTM D1876 and ASTMD2979 or other appropriate method. Other features
or
variations of the device are described in U.S. Appl. No. 11/888,978, filed on
August 3, 2007,
incorporated in its entirety herein by reference.
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The release liners may comprise any of a variety of materials, including both
opaque and
transparent materials. The release liners may comprise Mylar or paper, or any
other material
with reduced adhesion to the adhesive material(s) of the device. For example,
for a silicone
adhesive, a fluoropolymer-treated polyester film may be used, and for an
acrylic pressure
sensitive adhesive, a silicone treated polyester or Mylar film or silicone
treated craft paper may
be used. In variations where the device has multiple separate adhesive
regions, separate release
liners may be provided for each region, or some regions may be covered by the
same release
liner.
Examples of dressings, applicators or tensioning devices that may be used in
the devices
kits or methods herein may include those provided in U.S. Application Serial
No. 12/854,859
filed August 11, 2010, the disclosure of which is already incorporated in its
entirety herein by
reference without limitation.
The packaging assembly, applicator and/or tensioning device may comprise a
tensioning
structure, and a first attachment portion configured to releasably attach to a
dressing and a
second attachment portion configured to releasably attach to the dressing,
wherein the tensioning
structure may be configured to exert a separation force between the first
attachment portion and
the second attachment portion to cause a strain in a dressing attached to the
first and second
attachment portions. An elastic dressing may be configured to releasably
attach to the first and
second attachment portions of a dressing and packaging assembly and may
include an
attachment structure or may be integral with attachment structures of a
packaging device,
applicator or tensioning member. The tensioning structure may also act as an
applicator device
or may be configured to permit a user to apply a dressing to skin of a
subject.
Attachment structures of a packaging device, dressing assembly, dressing
carrier, support,
base, applicator, tensioning or straining device may include any structures
that are used to attach
or couple an applicator, tension or straining device to a dressing. A dressing
may or may not
have attachment features or structures. Any such attachment features may be
integral with or
include any of the attachment structures or corresponding structures to the
attachment structures
of the packaging, applicator dressing and/or tensioning device.
In some variations the assembly may comprise one or more mechanisms or
elements
configured to facilitate separation, release, removal or detachment of the
dressing from the
packaging, applicator or tensioning device, other attachment elements or other
portions of the
dressing assembly, including but not limited to the separation devices and
methods described
herein. Release elements or releasable attachment structures may include but
are not limited to
pockets and tabs, hook and loop mechanism, hooks, angled bars, pivoting,
rolling, rocking or
sliding features associated with or coupled to attachment structures ,
adhesives, removable
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adhesives, adhesive tapes or other adhesive devices, pegs, rip cords, towel
bar configurations,
sliding pins, friction locks, cam locks, vacuum or suction devices, snap
connectors, carpet tack,
press fit connections or other connections, levers, latches, locking members,
spring members, for
example, or other mechanisms such as cutters or rip cords or other structures
or features to
facilitate tearing, cutting or separation of attachment structures or elements
perforated or
otherwise severable structures, that permit removal of dressing from the
applicator, packaging,
other portions of the dressing assembly and/or attachment structures,
features, elements or
portions They may be self-releasing latches or spring members. They may be
actuated when a
pressure member is applied to a skin treatment device prior to removing the
applicator. They
may be manually actuated.
As noted, a packaging or applicator, tensioning device and/or straining device
may be
provided in some embodiments to impart a strain to a skin treatment device
with an external
force and/or to maintain a strain imparted to the skin treatment device. The
packaging, applicator
or tensioning device may be configured to pivot or rotate to tension the
dressing. In some
examples, the straining device may be configured to impart and/or maintain a
single
predetermined or pre-set strain or a plurality of predetermined or pre-set
strains, or
predetermined maximum or minimum amounts of strain. Features described herein
with respect
to a packaging assembly, applicator or tensioning device may also be used in
any device that is
used to strain a dressing. A packaging or applicator, tensioning or straining
device that is
described as being in an unstrained configuration is in a configuration in
which a dressing may
be unstrained or relatively less strained when attached to the packaging,
applicator, tensioning or
straining device. A packaging, applicator, tensioning, or straining device
that is described herein
as being in a strained configuration, is in a configuration in which a
dressing may be strained or
relatively more strained when attached to the packaging, applicator,
tensioning or straining
device, or with respect to an unstrained configuration, when applied to a
subject's skin.
Packaging devices, applicators, tensioning devices, and corresponding
attachment features
may be configured to provide multi-direction strain or additional strain in an
orthogonal direction
to a dressing.
The packaging device, applicator, tensioning device and/or attachment
structure profile
may he straight, curved or otherwise varied. For example, the shape of the
elements of a device
may be configured to follow the shape of the area of the subject's body to
which the skin
treatment device is to be attached. A packaging device, tensioning device,
applicator or elements
thereof may be selected or configured to have a profile that has a desirable
profile for a particular
body location or profile where the skin treatment device is to be placed on a
subject's skin. A
packaging device, applicator, tensioning device or elements thereof may be
selected or
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configured to closely match a portion of a subject's body profile. The
packaging device,
applicator or tensioning device and/or an element or segment thereof, may be
curved, curvable,
flexible, bendable, malleable, deformable, shapeable or movable to provide
alternative shapes or
profiles of an attached dressing. They may be relatively curved, curvable,
flexible, malleable,
bendable, deformable, shapeable or movable in at least one direction while
being more rigid in
another direction.
A variety of locking, latching, securing, attaching or detent mechanisms may
be used to
maintain the packaging, applicator or tensioning device in a various
configurations including but
not limited to unstrained, partially strained, strained configurations. A
variety of locking,
latching or detent mechanisms may be used to maintain a dressing in a variety
of configurations
including unstrained, partially strained, strained. By locking the packaging,
applicator,
tensioning device, or dressing in a strained position, a predetermined strain
of a given dressing
may be achieved. The predetermined amount of strain may be a predetermined
absolute
percentage of strain or level of force that is independent of the shape and/or
size of the treatment
site. As a further example, this absolute percentage of strain or level of
force may be
independent of the minimum strain or force to achieve sutureless wound closure
(e.g. a relative
strain or force to achieve opposition of the incision edges of a treatment
site). Furthermore, the
force needed to achieve wound closure is not a predetermined strain or force,
since the final level
of strain or force is not known until opposition of the incision edges is
achieved.
Referring to FIGS. 1 to 5C, a variation of a dressing and packaging assembly
100 is
illustrated. The packaging assembly 100 comprises a book-like applicator
and/or tensioning
device 120, a dressing assembly 110 including a dressing 130, and a release
150 configured to
release the dressing 130 from the applicator and/or tensioning device 120.
The dressing 130 comprises an elastic sheet 131with one or more adhesive
regions
comprising a layer of skin adhesive 135 on a first surface 135a. The adhesive
used may be, for
example, a suitable pressure activated adhesive (PSA), or a non-pressure
sensitive adhesive.
The packaging assembly 100, applicator or tensioning device 120 and/or
dressing assembly
110 may be configured to pre-strain the dressing 130 and/or permit transfer of
the pre-strained
dressing 130 to the skin of a subject. The applicator and/or tensioning device
120 may also
provide for a convenient, expeditious or sterile transfer of an adhesive
portion of the dressing
130 to a skin and/or wound site of a subject.
The device 120 comprises a cover 121 and a base 122. The dressing assembly 110
is
removably coupled or anchored to the device 120 which may act as a dressing
carrier or a
support. The cover 121 may be generally planar and include sides 123, 124 with
corresponding
edges 123a, 124a along its length, and edges 121a at opposing ends. The
dressing carrier or base
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122 may be generally planar and include sides 125, 126 with corresponding
edges 125a, 126a
along its length and edges 122a at opposing ends.
According to some variations, the cover and/or base 121,122 or elements or
segments
thereof may be constructed to be sufficiently firm or rigid or less flexible
relative to an attached
dressing to support an attached dressing until it is applied to a subject as
described with respect
to the variations herein. Such material may comprise, for example, a plastic,
e.g.,
polypropylene, polycarbonate, polytetrafluoroethylene (PTFE or TEFLON ), LDPE,
high-
density polyethylene (HDPE), ultra high-molecular weight polyethylene
(UHMVVPE), polyvinyl
chloride (PVC) or acrylic, nylon or a paperboard. The elements or segments may
be a laminate
of a material, such as a solid bleach sulfate paperboard with a layer of
flexible material between
layers of paperboard, for example, silicone, polyurethane, LDPE or a rubber
material. The
material may also be a metal as for example, ductile aluminum or stainless
steel. The metal may
comprise a foil, ribbon, wire or other form.
Cover 121 and base 122 are movably, hingedly or pivotably coupled at sides
123, 125. For
example, a layer of material such as silicone, polyurethane, low-density
polyethylene or a rubber
material may be glued to each of the cover and base, flexibly attaching them
together at sides
123, 125. Alternative devices and methods may be used to couple the cover 121
and base 122.
For example, various composite structures or laminates may be used. Also
devices may be
constructed out of a single substrate that provides flexibility in some
selected regions and rigidity
in others, or a relative or absolute flexibility in a first direction with a
relative or absolute rigidity
in a second direction that may be transverse to the first direction. Although
the cover 121 and
base 122 depicted in FIGS. 1 to 5C have generally the same size and shape, in
other examples,
the cover 121 and base 122 may be different sizes and/or shapes. Cover 121
and/or base 122
may be bendable, foldable, curvable, flexible, malleable or shapeable
permitting relatively more
even placement on a location with a varying shape or curvature. For example,
cover and base
121, 122 as illustrated are each divided into segments 127 along lengths that
are bendable or
movable with respect to adjacent segments, permitting flexibility of the
device 120 along its
length. The segments 127 may be constructed of a more rigid material that
reduces flexion in a
widthwise or other direction. Other configurations that vary the directions of
rigidity and/or
flexibility may be use. Configurations may include providing rigidity in a
direction in which a
dressing is strained that is sufficient to create and/or maintain a desired
level of strain. The
segments 127 may be coupled by a material, such as an elastomer, e.g.,
silicone that flexibly
holds the segments together in relationship to each other. Other construction
may also be used to
flexibly couple segments or other elements. The material coupling or binding
the cover and base
121, 122, may or may not be continuous with the material that couples the
segments 127 to
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adjacent segments 127, and may or may not be attached to all or a portion of a
side of cover and
base 121, 122. The various attached structures, e.g. the segments and/or the
cover and base and
coupling elements may provide a structural support for the dressing carrier to
be manipulated by
a user. Margins between at least a portion of the structural support elements,
dressing carrier or
backing, and the dressing may be provided at or near edges 121a, I23a, 124a,
122a, 125a, and/or
126a, for example as described further herein. In some further embodiments,
the material
attaching the cover 121 and base 122 may comprise a semi-rigid structure that
may be biased to
an open or a closed configuration, or a configuration therebetween. In still
other variations, the
cover 121 and base 122 may be attached by any of a variety of articulations,
including but not
limited to one or more a pin-based hinge joints, rings attached to holes in
the cover 121 and base
122, or ball-and-socket joints.
As exemplified in FIGS. 5A- 5C, a variation of construction of a package is
shown. Cover
121 and base 122 comprise relatively firm or rigid elements, for example
battens 121a, 121b and
battens 122a, 122b respectively that are attached by way of a sheet 128 of
material, such as, e.g.,
silicone, polyurethane, low-density polyethylene or a rubber material that
also flexibly couples
cover and base 121, 122 at sides 123, 125. Segments 127 may have alternative
shapes and
construction coupling the segments 127 together. Thus, the device 120 may be
constructed to
bend or curve to varied extents or in multiple directions. Accordingly, a
device may be
constructed to be used on a specific anatomical location or with varying
sizes, or may be
constructed to have a shape for a particular situation or individual.
According to some variations each of the cover 121 and base 122 is constructed
at least in
part of a clear plastic, semi-opaque or other material that provides a window
portion 159 through
which a wound, incision, or other location may be visualized for accurate
placement of the
dressing 130. The cover 121 and base 122 may or may not comprise the same
material. The
elastic sheet 131 and adhesive layer 135 may also be sufficiently clear to
permit visualization
through them. A more opaque material may be provided on portions of the
material to create
boundaries of a window 159. The segments 127 may be clear or semi-opaque to
provide the
window for viewing, positioning, and/or centering the location of a wound or
position on skin
with respect to the dressing 130 or for positioning the wound within an
optimal or most effective
strain zone of the dressing. The boundaries or other markings may assist a
user in placing the
dressing 130 in an appropriate position over the wound or incision.
The dressing 130 of the dressing assembly 110 has a first side or edge 133
having a length,
and a second side or edge 134 having a length. The dressing 130 is coupled to
the packaging
assembly 100 along the lengths of the dressing's sides 133, 134. When the
device 120 is closed,
the adhesive layer 135 faces away from the base 122 and is covered by a
release liner 149 that is
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attached to the inside surface 177 of the cover 121. The dressing assembly 110
also includes an
attachment sheet 141 having a first side 143 and a second side 144. The
attachment sheet 141
couples the dressing 130 to the cover of the device 120 which when opened,
exerts a straining
force on the dressing 130 through the attachment sheet 141. According to some
variations, the
attachment sheet 141 is flexible while being relatively inelastic with respect
to the dressing 130
and may be constructed, e.g., out of a low density polyethylene. When
assembled, the
attachment sheet 141 is bonded to the elastic sheet 131 of the dressing at
(for example, using a
combination of a silicone PSA/acrylic PSA) or near the sides 134 and 143 of
the dressing 130
and attachment sheet 141 respectively. The attachment sheet 141 is coupled at
its side 144 to the
cover 121 at attachment points 137 defining a line or area of attachment 137a
along the length of
the cover 121. The dressing 130 is coupled to the second side 124 of the base
122 at a location
near the first side 133 of the dressing 130. As such, the elastic sheet 131 is
attached at
attachment points 138 defining a line or area of attachment 138a along a
length of the base 122.
A number of bonding methods or adhesives may be used to attach the attachment
sheet 141 to
the cover 121, for example, a low surface energy PSA such as an acrylic
adhesive.
When the assembly 100 is in a closed configuration as illustrated in FIG. 1
and at an open
90 degree configuration as shown in FIG. 2, the elastic sheet 131 is relaxed
or unstrained, with
the elastic sheet 131 having an unstrained width wl. As the assembly 100 is
opened to 180
degrees or up to about 360 degrees (e.g. by rotating or pivoting the cover 121
with respect to the
base 122), the orthogonal distance increases between lines or areas of
attachment 137a, 138a.
According to some variations the assembly is opened to no less than about 180
degrees
(minimum angular change) to provide for application of a dressing without
interference of the
assembly 100. When the device 120 is opened, it exerts a separation force
between attachment
regions defined by attachment lines or areas 137a, 138a or corresponding
attachment areas. The
force tensions the elastic sheet, creating a strain. Tensioning and imparting
a strain on the
dressing 130 increases the width between attachment lines or areas 137a, 138a
to w2. The
increase in the width, i.e., w2 minus wl, may be a percentage of wl or a
percent strain as
described herein. While straining is illustrated as starting when the cover
121 is opened about 90
degrees from the base 122, the dressing 130 may be attached to the cover 121
at a number of
locations or in a number of configurations that may vary the cover position or
configuration at
which straining begins. The edge 124a or side 124 of the cover 121 may act as
a lever arm to
provide a mechanical advantage, which may depend, among other things, on the
distance of the
point of attachment 138 of the dressing assembly 110 on the cover to the edge
124a of the cover
121 as well as the angle of the cover 121 with respect to the base 122 at
which the tensioning of
the dressing occurs. Additionally, the point of attachment 138 of the
inelastic attachment sheet
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141 to the cover 121 may determine amount of strain applied to the dressing,
assuming among
other things, the length of the attachment sheet 141 remains the same and the
point of attachment
137 of the dressing assembly 110 to the base 122 remains the same
According to one variation, the dressing 130 may be substantially fixed at one
edge, (e.g.
at edge 134 at the side126 of the base 122) while not being fixed at an
opposite edge (e.g., edge
133 moves when strained with respect to edge 125a of base 122). When the cover
121 is opened
and the dressing 130 is strained, the width of the strained dressing may be
less than the width of
the base 122 and/or the cover 121so that the area of the dressing is located
over the area of the
base 122 and or the cover 121, i.e. the base 122 and/or cover 121 margins
outside of the area of
the dressing. According to other variations the dressing may be fixed at both
edges.
According to some variations, the dressing is sufficiently large with respect
to the device
120 so that when applied to the skin, there is relatively less interference by
the device 120.
According to one example, the width of the strained portion of the dressing
may be about 10
mm, about 20 mm, about 30 mm, about 40 mm, or about 50 mm. Other strained
dimensions
may be used. According other variations, the distance between each of edges
133, 134 of the
dressing 130 and the edges 125a, 126a of the base 122 respectively (and/or the
edges 123a, 124a
of the cover 121) is no greater than about lOmm, 15 mm or 20 mm. According to
some
variations, the distance between the edges 136a, 136b of the dressing and the
edges 122a of the
base is no greater than about 10 mm, about 15 mm or about 20 mm.
According to some variations, edges 133, 134, 136a, 136b of the dressing 130
are at least
about 1.0 mm inward of at least a portion of the edges 125a, 126a, and/or 122a
of the base 122 so
that the edges 125a, 126a, and/or 122a of the base 122 may be gripped by a
user with a reduced
likelihood of touching the dressing 130 or the adhesive layer 135. According
to some variations,
the ends 136a, 136b of the dressing 130 have a margin of at least about 1.0 mm
inward of the
ends 122a of the base 122. According to some variations the sides 133, 134 and
ends 136a, 136b
of the dressing 130 have a margin of about lOmm from the sides 125, 126 and
ends 122a of the
base respectively. According to some variations the sides 133, 134 and ends
136a, 136b of the
dressing 130 have a margin of about 15 mm from the sides 125, 126 and ends
122a of the base
respectively. Each of the margins between sides 133,134 or ends 136a, 136b of
the dressing 130
and sides 125, 125, and ends 122a of the base 122 may be different As
illustrated in FIG. 3, for
example, margins ml and m2 are about no less than 3mm and margin m3 is about
15 mm.
Similar margins may be provided between the dressing 130 and the edges 121a,
123a, and/or
124a of the cover 121, for example if the edges of the cover 121 are used
alternatively or
additionally to grasp the device 120 or manipulate the dressing 130. Then,
once the cover 121 is
opened and the adhesive layer 135 is exposed, the adhesive side of the
dressing 130 may be
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placed on a skin or wound site using the device 120. As shown in FIGS. 3 and 4
the cover 121
and base 122 may be rotated an additional amount, with respect to each other,
e.g., up to
approximately 360 degrees from the closed configuration prior to applying the
dressing 130. A
locking mechanism may optionally be provided to lock or secure the device in
an open, partially
opened or closed position. In some examples, the locking mechanism may
comprise magnets,
hook-and-look attachment structures, snaps, latches, clips and the like.
The adhesive layer 135 of the elastic sheet 131 is protected by a release
liner 149 before
the applicator or tensioning device 120 is opened. The release liner 149 is
attached or glued to
the inside surface 177 of the cover 121 so that when the cover 121 is opened
as shown in FIG. 2,
and is separated from the base 122 (prior to straining the elastic sheet 131),
the release liner 149
is pulled away from the elastic sheet 131 exposing the adhesive layer 135.
Alternatively, as
shown in FIG. 6, a release liner 149a may be provided on the adhesive layer
135 that is not
attached to the cover 121. When the device 120 is opened, and prior to
straining the dressing
130, the release liner 149a may be manually removed from the elastic sheet 131
to expose the
adhesive layer 135.
After the dressing 130 is strained, and the liner 149 or 149a is released, the
dressing 130
may be applied to a desired location on a subject's skin. The window 159 may
be used to
visualize proper placement. The user may apply pressure to the back side 129
of the device 120
to activate the adhesive on the elastic sheet 131 and/or to apply compression
to a wound.
Alternatively, if the cover 121 is rotated to 360 degrees, pressure may be
applied to the inside
177 of the cover 121. Once applied to a subject, the elastic sheet 131 may be
released from the
packaging, applicator or tensioning device 120 using a release structure or
mechanism 150.
The release mechanism 150 may comprise cutters 151 each positioned on opposite
sides
133, 134 of the elastic sheet 131. Each cutter 151 comprises a blade 152 on
one end 153 with
legs 154, 155 extending to opposing pull tab or tabs 156 on an opposite end
157. The blade 152
comprises a sharp surface that may be generally v-shaped or otherwise shaped.
The blade may
be constructed, e.g., of stainless steel, ceramic or hard plastic. The blade
152 and the pull tabs
156 each extend proud of the ends 136a, 136b of elastic sheet 131,
respectively and ends 122a of
the base 122. Cutters 151 are attached to the dressing assembly 110 in a
manner that defines
general cutting paths 162, 163 (depicted best in FIG. 5A) along which the
blades 152 are pulled
by tabs 156 to cut the dressing assembly 110 to release the dressing 130. In
some variations, the
dressing may be scored, perforated or otherwise configured to facilitate
separation by the release
mechanism.
As best shown in FIGS. 5B and 5C, tubes 164, 165 for receiving and guiding
legs 154,
155 respectively of a cutter 151, are positioned along the side 133 of the
elastic sheet 131. The
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tubes 164, 165 may be positioned so that the cutting path 162 is between the
tube 164 and the
tube 165. The tube 165 is coupled, e.g., glued to the adhesive surface 135 of
the elastic sheet
131 at a location closer to the side 133 than the cutting path 162. The tube
164 is coupled to the
back surface 139 of the elastic sheet 131 by way of the attachment sheet 141,
which is also
coupled to the elastic sheet 131 at a location closer to the side 133 than the
cutting path 162. The
tube 164 is coupled to a free end 145 of the attachment sheet 141 that extends
inward of the
cutting path 162 with respect to the side 133. Thus, the tube 164 may be
positioned inside of
the cutting path 162 without being attached to the elastic sheet 131 inside of
the cutting path 162.
This allows the dressing 130 to be released from the remainder of the
packaging assembly 100
including the cutter 151 with tube 164 and attachment sheet 141. A protective
member 170 is
attached, e.g. glued to the top of tube 165. The protective member 170
includes a ledge 171 that
extends over the cutting path 162 so that when the adhesive layer 135 is
positioned on the skin of
a subject and the cutter 151 is actuated, the skin is protected from the blade
152.
Tubes 174, 175 for receiving and guiding legs 154, 155 respectively are
positioned along
the side 134 of the elastic sheet 131. The tubes 174, 175 are positioned so
that the cutting path
163 is between the tube 174 and the tube 175. The tube 175 is coupled, e.g.,
glued to the
adhesive surface 135 of the elastic sheet 131 at a location closer to the side
134 of elastic sheet
131 than the cutting path 163. The tube 174 is coupled to the back surface 139
of the elastic
sheet 131 by way of the extender sheet 146. The tube 174 is coupled to a free
end 147 of the
extender sheet 146 that extends inward of the cutting path 163 with respect to
the side. Tube 174
is also coupled to the elastic sheet 131 at a location closer to the side 134
than the cutting path
163. Thus the tube 174 may be positioned inside of the cutting path 163
without being attached
to the elastic sheet 131 inside of the cutting path 163. This allows the
dressing 130 to be
released from the remainder of the packaging assembly 100 including the cutter
151 with tube
175 and extender sheet 146. A protective member 170 is attached, e.g., glued
to the top of tube
175. The protective member 170 includes a ledge 171 that extends over the
cutting path 163 so
that when the adhesive layer 135 is positioned on the skin of a subject and
the cutter 151 is
actuated, the skin is protected from the blade 152.
The inside of the tubes 164, 165, 174, 175 may be coated with a lubricious
material, e.g.
with Kapton tape. The guiding legs 154, 155 may be constructed of a low
friction material such
as, e.g., HDPE or UHMWPE, so the legs 154, 155 may readily slide in the tubes
164, 165, 174,
175 to permit smooth cutting of the dressing 130 from the remainder of the
packaging assembly
100.
When the dressing 130 is strained and the adhesive 135 is exposed, the
dressing 130 may
be applied with the adhesive side 135 towards the skin of a subject. The side
133 of the elastic
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sheet may then be released from the applicator by pulling the tabs 146 to draw
the blade 152
across cutting path 162. Also, the side 134 of the elastic sheet may then be
released from the
applicator by pulling the tabs 146 to draw the blade 152 across cutting path
163. Thus the elastic
sheet 131 is released from the packaging 100 (including the release 150).
Referring to FIGS. 7 to 9, another variation of a dressing and packaging
assembly 200 is
illustrated. The packaging assembly 200 comprises an applicator and/or
tensioning device 220
and a dressing assembly 210 including a dressing 230. The dressing 230
comprises an elastic
sheet 231with one or more adhesive regions comprising a layer of skin adhesive
235. The
adhesive used may be, for example, a suitable pressure activated adhesive
(PSA), or a non-
pressure sensitive adhesive.
The packaging assembly 200, applicator or tensioning device 220, and/or
dressing
assembly 210 may be configured to pre-strain the dressing 230 and/or permit
transfer of the pre-
strained dressing 230 to the skin of a subject The applicator or tensioning
device 220 may also
provide for a convenient sterile transfer of an adhesive portion of the
dressing to a skin and/or
wound site of a subject.
The device 220 may comprise a cover 221 and a base 222. The dressing assembly
210 is
removably coupled or anchored to the device 220, and may serve as a dressing
carrier. The
cover 221 may be generally planar and include sides 223, 224 with
corresponding edges 223a
and 224a defining its length and edges 221a at opposing ends. The base 222 may
be generally
planar and include sides 225, 226 with corresponding edges 225a and 226a
defining its length
and edges 222a at opposing ends.
According to some variations, the cover and/or base 221,222 or elements or
segments
thereof may be constructed to be sufficiently firm or rigid or less flexible
relative to an attached
dressing to support an attached dressing until it is applied to a subject as
described with respect
to the variations herein. Such material may comprise, for example, a plastic,
e.g., polypropylene,
polycarbonate, PTFE, LDPE, HDPE, UHMVVPE, PVC or acrylic, nylon or a
paperboard. The
elements or segments may be a laminate of a material, such as a solid bleach
sulfate paperboard
with a layer of flexible material between layers of paperboard, for example,
silicone,
polyurethane, low-density polyethylene or a rubber material, The material may
also be a metal
as for example, ductile aluminum or stainless steel. The metal may comprise a
foil, ribbon,
wire or other form. The other variations as described for application or
tensioning device 100
may be applied to device 200 also.
The cover and base 221 and 222 may be movably, pivotably, bendably or hingedly
coupled
at sides 223, 225 in a manner similar to that described with respect to cover
and base 121, 122
herein and may be constructed in a manner similar to cover and base 121, 122
herein, among
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other things, with segments 227 similar to segments 127 and dressing 230
attached to device 220
and strained by device in a similar manner as dressing 130 is attached to
device 120.
The various attached structures, e.g. the segments and/or the cover and base
and coupling
elements may provide a structural support for the dressing carrier to be
manipulated by a user.
Margins between at least a portion of the structural support elements,
dressing carrier or backing
and the strained or unstrained dressing may be provided at or near edges 221a,
223a, 224a, 222a,
225a, and/or 226a, such as, for example, margins ml, m2, m3 shown in FIG. 3
herein.
According to some variations, each of the cover 221 and base 222 is
constructed at least in
part of a clear plastic, semi-opaque or other material that provides a window
portion 259 through
which a wound, incision or other location may be visualized for accurate
placement of the
dressing 230. The cover 221 and base 222 may or may not comprise the same
material. The
elastic sheet 231 and adhesive layer 235 may also be sufficiently clear to
permit visualization
through them. A more opaque material may be provided on portions of the
material to create
boundaries of a window. Segments 227 may be clear or semi-opaque to provide a
window for
viewing, positioning, and/or centering the location of a wound or position on
skin with respect to
the dressing 230 or for positioning the wound within an optimal or most
effective strain zone of
the dressing. The boundaries or other markings may assist a user in placing
the dressing in an
appropriate position over the wound or incision.
The dressing assembly 210 also includes an attachment sheet 241, attachment
sheet 251,
and a dressing release structure or mechanism 250 comprising pull tabs 246 as
described in more
detail herein. The dressing 230 of the dressing assembly 210 has a first side
233 having a length,
and a second side 234 having a length. When the device 220 is closed, the
adhesive layer 235
faces away from the base 222 and is covered by a release liner 249 that is
attached to the inside
surface 277 of the cover 221.
The attachment sheet 241 has a first side 243 and a second side 244. The
attachment sheet
241 couples the dressing 230 to the cover 221 of the device 220 near the
second side 234 of the
dressing 230. The cover 221, when opened, exerts a straining force on the
dressing 230 through
the attachment sheet 241. The attachment sheet 241 is coupled at its side 244
to the cover 221 at
attachment points 237, which may be provided as an attachment line or area
237a, for example,
by bonding with a low surface energy PSA such as an acrylic adhesive_ When
assembled, the
attachment sheet 241 is bonded to the elastic sheet 231 of the dressing 230 at
section 265 of
attachment sheet 241 at or near the side 243 of the attachment sheet 241, for
example, using a
combination of a silicone PSA/acrylic PSA. The attachment sheet 251 has a
first side 253 and a
second side 254. The attachment sheet 251 couples the dressing 230 to the base
222 of the
device 220 near the first side 233 of the dressing 230. The attachment sheet
251 is coupled at its
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side 254 to the base 222 at attachment points 238 defining the attachment line
or area 238a, for
example, by bonding with a low surface energy PSA, such as an acrylic
adhesive. When
assembled, the attachment sheet 251 is bonded to the elastic sheet 231 of the
dressing at section
265 of attachment sheet 251 at or near the side 253 of the attachment sheet
251, for example,
using a combination of a silicone PSA/acrylic PSA.
Dressing 230 has unattached portions or edges 255 at its sides 233, 234 where
the elastic
sheet 231 is free from the attachment sheets 241, 251 respectively.
Accordingly, the dressing
230 is not strained at unattached portions 255. The pull tabs 246 are each
coupled to ends 281,
282 of the device 220. Each pull tab 246 comprises atop section 247 and bottom
section 248.
The bottom sections 248 are attached to the base 222 or cover 221 as
illustrated while top
sections 247 are adjacent but unattached to the dressing 230.
According to some variations, the attachment sheets 241, 245 are flexible
while being
relatively inelastic with respect to the dressing 230 and may be constructed,
e.g., out of a low
density polyethylene. The attachment sheets 241, 245 may be manufactured to be
tearable along
the material length while providing tensile strength in other directions, in
particular in the
tensioning direction of the material of the attachment sheet 241(direction in
which dressing is
tensioned, stressed or strained) . An example of such material is an LDPE
polymer which is
produced by an extrusion process that creates a directionally biased grain
whereby the material is
tearable with the direction of the grain, but has a relative resistance to
tearing in the direction
transverse to the grain. The pull tab 246 may start a tear at a notch in the
attachment sheet 241
or 251 that is to be completed along lines 262. The attachment sheets 241, 251
may additionally
or alternatively comprise a material such as an LDPE with perforations formed
along tear lines
262.
Similar to assembly 100 herein, when the assembly 200 is in a closed
configuration and at
an open 90 degree configuration as shown in FIG. 7, the elastic sheet 231 is
relaxed or
unstrained, with the elastic sheet 231 having an unstrained width w3. As the
assembly 200 is
opened to 180 degrees or up to 360 degrees (e.g. by rotating or pivoting the
cover 221 with
respect to the base 222), the orthogonal distance increases between lines or
areas of attachment
237a, 238a. When the device 220 is opened, it exerts a separation force
between attachment
regions defined by attachment lines or areas 237a, 238b or corresponding
attachment areas. The
force tensions the elastic sheet 231 creating a strain. Tensioning and
imparting a strain on the
dressing 230 increases the width between attachment lines or areas 237a, 238a
to widthw4. The
increase in the width (i.e. width w4 minus width w3) may be a percentage of w3
or a percent
strain as described herein. While straining is illustrated as starting when
the cover 221 is opened
about 90 degrees from the base 222. The dressing 230 may be attached to the
cover 221 at a
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number of locations or in a number of configurations that may vary at which
position or
configuration the cover 222 may be when the straining begins.
As shown in FIGS. 8 to 8B, the cover 221 and base 222 may be rotated an
additional
amount, with respect to each other, e.g., up to approximately 360 degrees from
the closed
configuration prior to applying the dressing 230. According to some variations
the assembly is
opened to no less than about 180 degrees (minimum angular change) to provide
for application
of the dressing without interference from the assembly.
Then, once the cover 221 is opened and the adhesive layer 235 is exposed, the
adhesive
side of the dressing 230 may be place on a skin or wound site using the device
220. The cover
221 and base 222 may be rotated an additional amount, with respect to each
other, e.g., up to
approximately 360 degrees from the closed configuration prior to applying the
dressing 230.
The orientation of the cover 221 at which the dressing 230 begins to strain
may be varied, e.g. by
varying the attachment location of the dressing assembly 210 to the cover 221.
A locking
mechanism may optionally be provided to lock or secure the device in an open,
partially opened
or closed position. In some examples, the locking mechanism may comprise
magnets, hook-and-
loop attachment structures, snaps, latches, clips and the like.
The adhesive layer 235 of the elastic sheet 231 is protected by a release
liner 249 before
the applicator and tensioning device 220 is opened. The release liner 249 is
attached to the
inside surface 277 of the cover 221 so that when the cover 221 is opened and
is separated from
the base 222, (prior to straining the elastic sheet 231) the release liner 249
is pulled away from
the elastic sheet 231 exposing the adhesive layer 235 prior. Alternatively, as
shown in FIG. 6, a
release liner 149a may be provided on the adhesive layer 235 that is not
attached to the cover
221. When the device 220 is opened, but prior to straining, the release liner
149a may be
manually removed from the elastic sheet 231 to expose the adhesive layer 235.
After the liner 249 or 149a is released and the dressing 231 is strained, the
dressing 230
may be applied to a desired location on a subject's skin. The window may be
used to visualize
proper placement. The user may apply pressure to the back side 229 of the
device 220 to
activate the adhesive on the dressing 231 and/or to apply compression to a
wound. If the cover
221 is rotated to 360 degrees, pressure may be applied to the inside 277 of
the cover 221. Once
applied to a subject, the dressing 230 may be released from applicator or
tensioning device 220
using the release mechanism 250.
The pull tabs 246 of the release mechanism 250 each extend proud of the end
236a of
elastic sheet 231. Each release pull tab 246 is attached to the dressing
assembly 110 in a manner
that defines tear paths 262 along which the tabs 246 are pulled to separate
the dressing 230 from
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the device. Notches or perforations may be made in the attachment sheets 241,
251 that
facilitate tearing along paths 262.
The dressing 230 is applied to a subject. The dressing 230 may then be
released from the
device 220 by pulling the tabs 246 to draw the tabs 246 across paths 262 of
the attachment sheets
241, 251. The sections 245 of the attachment sheets 241, 251 that bonded to
the pull tabs 246
are thereby separated from the attachment sheets thereby separating the
sections 265 of the
attachment sheets that are attached to the dressing 230 are from the remainder
of the attachment
sheets 241 and 251 that are attached to the cover 221 and base 222
respectively. Thus, the
dressing 230 is released from the remainder of the packaging 100 as shown in
FIG. 9. Sections
265 of the attachment sheets 241, 251 may remain on the back surface 239 of
the silicone sheet
231 as shown in FIG. 9. Unattached sections 245of the elastic dressing 230 are
unstrained and
may be free from the adhesive of the adhesive layer 235 (or may have a reduced
amount of
adhesive thereon). Thus less stress occurs at the unattached sides or edges
defined by sections
245.
Referring to FIGS. 10 to 12B, a dressing and packaging assembly 300 is
illustrated. The
packaging assembly 300 comprises a packaging device applicator 320 and a
dressing assembly
310 including a dressing 330.
The packaging device or applicator 320 is configured to permit transfer of the
dressing 330
to the skin of a subject and may also provide for a convenient, expeditious or
sterile transfer of
an adhesive portion of the skin treatment device to a skin and/or wound site
of a subject.
The packaging device or applicator 320 comprises a cover 321 and a bottom
element,
dressing carrier or base 322, to which dressing assembly 310 is removably
coupled or anchored.
The cover 321 may be generally planar and include sides 323, 324 with
corresponding edges
323a, 324a defining its length and edges 321a at opposing ends. The base 322
may be generally
planar and include side 325, 326 with corresponding edges 325a, 326a defining
its length and
edges 322a at opposing ends.
According to some variations, the cover 321 and base 322 are constructed in
part of a
relatively inflexible material, e.g., with respect to an attached dressing
330. Such material may
comprise, for example, a plastic, paperboard or a laminate of a material, or
metal as described
herein with reference to cover 121 and base 122. The cover or base may be
constructed in a
manner as described, for example, with respect to the various applicator,
tensioning devices or
dressing carriers shown in FIGS. 1 to 22B herein. The cover 321 and base 322
may or may not
comprise the same material.
Cover 321 and base 322 may be movably, pivotably, bendably or hingedly coupled
at sides
323, 325 and otherwise constructed in a manner similar to that described
herein with respect to
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cover 121 and base 122. The packaging device or applicator 320 may include a
window portion
359 through which a wound, incision, or other location may be visualized for
accurate placement
of the dressing 330 in a manner similar to that described herein with respect
to the use of
windows 159, 259.
The assembly 300 is constructed including a dressing assembly 310 with a skin
dressing
device 330. The dressing assembly 310 also includes a dressing release
structure or mechanism
350 which may be a release device such as various release and removal
structures described
herein with reference to FIGS. 1 to 22B. The dressing 330 may comprise a
variety of dressing
materials, including but not limited to elastic bandages, gauze type bandages,
hydrocolloids. The
various structures, e.g. the segments and/or the cover and base and coupling
elements may
provide a structural support for the dressing carrier to be manipulated by a
user. Margins
between at least a portion of the structural support elements, dressing
carrier or backing and the
dressing may be provided at or near edges 321a, 323a, 324a, 322a, 325a, and/or
326a, for
example as described herein.
When assembled with the packaging device or applicator 320, the dressing 330
is coupled
to the base. A length of the dressing 330 adjacent its first side 333 is
bonded to a length of the
base 322 adjacent its side 324 and outside of release 350. Also a length of
the dressing 330
adjacent its second side 334 is coupled to a length of the base 322 adjacent
its side 325 and
outside of release 350. An attachment sheet similar to sheets 141, 146 or 241,
251 may be used
to attach sides 333, 334 of dressing 330 to the base 322. The adhesive layer
335 faces away
from the cover 32 land base 322 when the applicator 320 is opened.
According to variation, the dressing 330 is sufficient large with respect to
the device 320
so that when applied to the skin, there is relatively less interference by the
device 320.
According to one example, the width of the strained portion of the dressing
may be about 20
mm, about 30 mm, about 40 mm, or about 50 mm. According other variations, the
distance
between each of edges 333a, 334a of the dressing 330 and the edges 325a, 326a
of the base 322
respectively (and/or the edges 323a, 324a of the cover 321) is no greater than
about lOmm, 15
mm or 20 mm. According to variations the distance between the edges 336a, 336h
of the
dressing and the edges 322a of the base is no greater than about 10 mm, about
15 mm or about
20 mm.
According to some variations, edges 333, 334, 336a, 336b of the dressing 330
are at least
about 3mm inward of at least a portion of the edges 325a, 326a, and/or 322a of
the base 322 so
that the edges 325a, 326a, and/or 322a of the base 322 may be gripped by a
user with a reduced
likelihood of touching the dressing 330 or the adhesive layer 335. According
to some variations,
the ends 336a, 336b of the dressing 130 have a margin of at least about 3 mm
inward of the ends
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322a of the base 322. According to some variations the sides 333, 334 and ends
336a, 336b of
the dressing 330 have a margin of about lOmm from the sides 325, 326 and ends
322a of the
base respectively. According to some variations the sides 333, 334 and ends
336a, 336b of the
dressing 330 have a margin of about 15 mm from the sides 325, 326 and ends
322a of the base
respectively. Each of the margins between edges 333,334 or ends 336a, 336b of
the dressing
330 and sides 325, 325, and ends 322a of the base 322 may be different. As
illustrated in FIG. 3,
for example, margins ml and m2 are about no less than 3mm and margin m3 is
about 15 mm.
Similar margins may be provided between the dressing 330 and the edges 322a,
325a, and/or
326a of the base 322, Also similar margins may be provided between the
dressing 330 and the
edges 321a, 323a, and/or 324a of the cover 321, for example if the edges of
the cover 321 are
used alternatively or additionally to grasp the device 320 or manipulate the
dressing 330.
The adhesive layer 335 on the dressing 330 may be protected by a release liner
349 before
the packaging device or applicator 320 is opened. The release liner 349 may be
attached to the
inside surface 377 of cover 321 so that when the cover 321 is opened or is
separated from the
base 322, the release liner 349 is pulled away from the dressing 330 exposing
the adhesive layer
335. The release liner 349 may also be a protective liner that protects or
covers the dressing
prior to application. For example, the liner may cover a dressing to which a
substance or
medicament or other agent is applied. One or more hemostatic or coagulative
agents may be
applied to, or otherwise integrated with dressing to help reduce bleeding.
Potential agents include
chitosan, calcium-loaded zeolite, microfibrillar collagen, cellulose,
anhydrous aluminum sulfate,
silver nitrate, potassium alum, titanium oxide, fibrinogen, epinephrine,
calcium alginate, poly-N-
acetyl glucosamine, thrombin, coagulation factor(s) (e.g. II, VII, VII, X,
XIII, Von Willebrand
factor), procoagulants (e.g. propyl gallate), antifibrinolytics (e.g. epsilon
aminocaproic acid),
and the like. In some variations, the agents may be freeze-dried and
integrated into the dressing
and activated upon contact with blood or other fluid. In some further
variations, an activating
agent may be applied to the dressing or the treatment site before the dressing
is used on the
subject. In still other examples, the hemostatic agent may be applied
separately and directly to
the wound before application of the dressing, or after application to the
dressing via a catheter or
tube. The devices may also comprise one or more other agents that may be any
suitable agent
that may be useful in aiding in some aspect of the wound healing process. For
example, the
active agent may be a pharmaceutical compound, a protein (e.g., a growth
factor), a vitamin
(e.g., vitamin E), or combinations thereof Of course, the devices may comprise
more than one
medicament or agents, and the devices may deliver one or more medicaments or
agents. An
example of such medicament may include, but is not limited to various
antibiotics (including but
not limited to cephalosporins, bactitracin, polyxyxin B sulfate, neomycin,
polysporin),
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antiseptics (such as iodine solutions, silver sulfadiazine, chlorhexidine),
antifungals (such as
nystatin), antiproliferative agents (sirolimus, tacrolimus, zotarolimus,
biolimus, paclitaxel), grow
factors (such as VEGF) and other treatments (e.g. botulism toxin). The cover
321 may be pulled
away or separated in a number of manners. The cover 321 may be opened like a
cover of a
book. Similar to devices 120 and 220, 420, 520, 620, 720, 820, 920,1020
herein, the elements
321, 322 may be rotated sufficiently to separate the release liner 349 and up
to approximately
360 degrees allowing the exposed adhesive side 335 of the dressing 330 to be
place on a skin or
wound site using the packaging device or applicator 320. According to some
variations the
assembly 300 is opened to no less than about 180 degrees (minimum angular
change) to provide
for application of the dressing without interference of the assembly 300.
Alternatively, for
example, the cover 321may be attached to the base 322 by an adhesive and may
be peeled off of
the dressing 330 or the base 322 to which the dressing 330 is coupled. The
cover 321 itself may
be a removable, or separable release liner that may be peeled from the base
322. Alternatively,
as shown in FIG. 6, a release liner 149a may be provided on the adhesive layer
335 that is not
attached to the cover 321. When the device is opened, the release liner 149a
may be manually
removed from the dressing 330 to expose the adhesive layer 335. In such case,
the cover 321
may be omitted. After the device 300 is opened to position shown in FIGS. 11
or 12A and 12B,
the dressing 330 may be applied to a desired location on a subject's skin. The
window 359 may
be used to visualize proper placement. A locking mechanism may optionally be
provided to lock
or secure the device in an open, partially open, or closed position. In some
examples, the locking
mechanism may comprise magnets, hook-and-look attachment structures, snaps,
latches, clips
and the like as well as adhesives, or other adhesive structures. A compressive
force may be
applied to the back side 378 of base 322 or inside 377 of cover if rotated
approximately 360
degrees. Once applied to a subject, the dressing 330 may be released from
packaging device or
applicator 320 using a release mechanism 350. The release mechanism 350 may
include a
cutting element or a perforated element as described for example with respect
to devices 150 and
250 herein. The release mechanism may further include one more release
elements described
herein and show in FIGS. 1 to 22B.
FIG. 13 illustrates an alternative packaging or applicator 420 that may be
used in any of
the embodiments herein including device elements or features that may be
substituted for device
elements or features of devices 120, 220 or 320, 520, 620, 720,820,920, 1020,
1120, 1220. FIG.
13 illustrates a cover 421 and a dressing carrier or base 422 that are
constructed of a single
substrate out of a material such as nylon and/or polyethylene or a metal. The
device 420 may be
manufactured from a single mold and/or may have portions cut out of the
substrate, slots,
grooves, scoring or other openings or variations in thickness of the substrate
at different
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locations. The cover 421 and base 422 each comprise slots 428 that form
elements such as
segments 427. The slots 428 permit flexion of the device 420 allowing it to
conform to a
subject's body contours where an attached dressing is to be applied. Cover 421
and base 422 are
coupled to each other by way of connection features 429 that are formed in the
substrate. The
cover 421 and base 422 are hingedly or pivotably moveable with respect to each
other by virtue
of slots 430 that are formed adjacent connection features 429, to permit
flexion or movement of
the connector features 429 and thus the cover 421 and base 422 with respect to
each other. As
mentioned with respect to device 100, in other variations, slots 430 may
comprise grooves or
other structures providing a reduced thickness relative to the cover 421 and
base 422. The
device 420 may include a release mechanism as described with respect to FIGS.
1A-22B herein.
The device 420 may be used in the same manner as the devices described with
reference to
FIGS. lA to 22B herein and may attach a dressing in the same manner as
described with respect
to devices described with reference to FIGS. 1A to 22B herein.
The various structures, e.g. the segments and/or the cover and base and
coupling elements,
slots and grooves may provide a structural support as well as flexibility for
the dressing carrier to
be manipulated by a user. Margins between at least a portion of the structural
support elements,
dressing carrier or backing and an attached dressing may be provided at or
near edges 421a,
423a, 424a, 422a, 425a, and/or 426a, for example as described further herein.
FIG. 14 illustrates an alternative packaging or applicator device 520 that may
be used in
any of the devices described herein with reference to FIGS. 1A to 22B. A cover
portion 521 and
a dressing carrier or base portion 522 may be constructed of a laminate
structure 530. A first
layer 531 of the laminate structure 530 comprises a paperboard or other
support material such as
a plastic material or metal having slots 528 formed widthwise across each of
the cover 521 and
base 522. The slots 528 form segments 527 that permit flexion of segments
527of the device 520
allowing it to conform to a subject's body contours where an attached dressing
is to be applied.
The first layer 531 further comprises lengthwise slot 529 between the cover
521 and base 522
formed in the first layer 531. The first layer 531 further comprises tabs 540
with openings that
are used in assembly of the device 520 and are removed after assembly so that
the cover 521 and
base 522 are separated by slot 529 and are no longer connected by the first
layer 53E The
second layer 532 of the laminate comprises an adhesive material such as a PSA
acrylic, rubber or
silicone adhesive. The second layer 532 may or may not be about .001 to .006
thick. A flexible
strip 534 of material is positioned along the length of the device 520 over
the slot 529 and
connecting the cover 521 and base 522. The cover 521 and base 522 are flexibly
and hingedly or
pivotably coupled and moveable with respect to each other by way of the strip
534 of material
over the slot 529 to permit flexion or movement of the cover 521 and base 522
with respect to
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each other. The flexible strip 534 is attached with an adhesive 535 to a third
layer 533 that
comprises a thin material such as paper or plastic that may have generally a
similar outline as the
first layer 531 and that holds the structure of the device 520, including
segments 527, together.
The device 520 may include a release mechanism, dressing attachment and may be
used
in the same manner devices and assemblies as described with respect to FIGS.
1A-22B herein.
The various structures, e.g. the segments, adhesive structures, laminate
layers and/or the
cover and base and coupling elements, slots and grooves may provide structural
support as well
as flexibility for the dressing carrier, to facilitate manipulation by a user.
Margins between at
least a portion of the structural support elements, dressing carrier or
backing and an attached
dressing may be provided at or near edges 521a, 523a, 524a, 522a, 525a, and/or
526a, for
example as described further herein.
Referring to FIGS. 15A to 15J, a variation of a dressing and packaging
assembly 600 is
illustrated. The packaging assembly 600 comprises an applicator and/or
tensioning device 620
and a dressing assembly 610 including a dressing 630. The dressing 630
comprises an elastic
sheet 631, with one or more adhesive regions comprising a layer of skin
adhesive such as
described herein.
The features in FIGS. 15A to 15J may be used in any of the variations herein
including
device elements or features that may being substituted for device elements or
features of devices
and assemblies shown in FIGS. 1A to 22B.
The packaging assembly 600 applicator, tensioning device 620 and/or dressing
assembly
610 may be configured to pre-strain the dressing 630 and/or permit transfer of
the pre-strained
dressing 630 to the skin of a subject. The applicator or tensioning device 620
may also provide
for a convenient sterile transfer of an adhesive portion of the dressing to a
skin and/or wound site
of a subject.
The device 620 comprises a cover 621 and a base 622. The dressing assembly 610
is
removably coupled or anchored to the device 620 which may act as a dressing
carrier. The cover
621 may be generally planar and include sides 623, 624 with corresponding
edges 623a and 624b
defining its length and edges 621a at opposing ends. The base 622 may be
generally planar and
include sides 625, 626 with corresponding edges 625a and 626a defining its
length and edges
622a at opposing ends.
According to some variations, the cover 621 and/or base 622 or elements or
segments
thereof may be constructed to be sufficiently firm or rigid or less flexible
relative to an attached
dressing to support an attached dressing until it is applied to a subject as
described with respect
to the variations herein. The materials and construction of the applicator or
tensioning device
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620, dressing 630 and packaging 600 may be of similar to the packaging
assemblies and/or
dressings described in variations herein and shown in FIGS. 1A to 22B.
The cover 621 and base and 622 may be movably, pivotably, bendably or hingedly
coupled
at sides 623, 624. For example, a layer of material 627 such as silicone,
polyurethane, low-
density polyethylene or a rubber material may be glued to each of the cover
and base, flexibly
attaching them together at sides 623, 625. The device 620 may be constructed
in a manner
similar to that described with respect to other devices herein and shown in
FIGS. 1A to 22B and
may be constructed in a similar manner as described herein including but not
limited to with
respect to materials, segmentation, strength and flexibility, visualization,
straining mechanisms,
and release liners.
The dressing assembly 610 also includes an attachment sheet 641, attachment
sheet 651.
The attachment sheet 641 has a first side 643 that is attached to the second
side 634 of the
dressing by way of an adhesive structure 670 such as polyimide film or tape
(e.g. KAPTONR by
DuPontTM) or a peelable adhesive. Adhesive structures herein may include but
are not limited to
KAPTONO tape or peelable adhesive configured to provide low skin trauma after
repeated skin
contact or a soft skin adhesive, made of material such as silicone adhesive,
silicone gel, or
acrylic adhesive. The adhesive structure or KAPTONliz tape also comprises a
material that is
able to adhere to the attachment sheets to impart strain to the dressing when
the attachment
sheets are separated from each other, while being peelable from a selected
dressing material.
As shown in FIG. 15J, the attachment sheet 641 and side 634 of the dressing
may be
attached on same side 671 of the adhesive structure 670 with the attachment
sheet 641
overlapping but unattached to the dressing 631.
The attachment sheet 641 has a second side 644 that is coupled to the cover
621 of the
device 620 for example, by bonding with a low surface energy PSA, such as an
acrylic adhesive.
Attachment sheet 641 may also have a score or perforation 681 between its
attachment to the
adhesive structure 670 and its attachment to the cover 621. After the dressing
has been strained,
the perforation 681 is located at the seam between the cover 621 and the base
622, or over the
inside surface of the cover 621.
The attachment sheet 651 may be coupled at its side 654 to the back side 698
of the base
622 for example, by bonding with a low surface energy PSA, such as an acrylic
adhesive_ The
side 653 of attachment sheet 651 may be attached to the side 633 of the
dressing by way of an
adhesive structure 680 such as KAPTONO tape or a peelable adhesive, and in a
manner similar
to the adhesive structure 670 that attaches the side 654 of the dressing 630
to the attachment
sheet 641. The attachment sheet 651 may include a pull tab 688 that is located
on the back side
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698 of the base adjacent and inside of the attachment zone 655 of the
attachment sheet 651 to the
back of the base 652.
The cover 621, when opened, exerts a straining force on the dressing 630
through the
attachment sheet 641.
According to some variations, the attachment sheets 641, 651 are flexible
while being
relatively inelastic with respect to the dressing 630 and may be constructed,
e.g., out of a low
density polyethylene. The attachment sheets 641, 651 may be manufactured to be
tearable along
the material length while providing tensile strength in other directions, in
particular in the
tensioning direction of the material of the attachment sheet 641(direction in
which dressing is
tensioned, stressed or strained) . An example of such material is an LDPE
polymer which is
produced by an extrusion process that creates an anisotropic or directionally
biased grain
whereby the material is tearable with the direction of the grain, but has a
relative resistance to
tearing in the direction transverse to the grain.
FIG. 15A shows the assembly 600 in an unstrained configuration. An adhesive
tape 683 is
exposed on the inside surface 694 of the base 622. A skin adhesive layer on
the elastic sheet 631
of the dressing 630 may be protected by a release liner similar to release
liner 149a herein before
the applicator or tensioning device 620 is opened
FIG. 15B shows the assembly 600 in an opened and strained configuration. As
shown in
FIG. 15B, when strained, the perforation 681 on the attachment sheet is
aligned with the edges
623a and 625a of the cover 621and base 622, respectively. A portion 641a of
the attachment
sheet 641 interfaces with the adhesive tape 683 attaching portion 641a to the
base 622 and
holding the dressing 630 in the strained configuration. A release liner 645 is
attached to the
underside of the attachment sheet 641 between the attachment to the cover 621
and the
perforation 681. The liner 645 prevents the portion of the attachment sheet
641 that interfaces
the cover 621 from adhering to the adhesive tape 683.
The cover 621 and base 622 may be separable from each other by way of, for
example, a
perforation 682 in the layer 627 that couples the cover 621 to the base 622
and by separation of
the sheet 641 along perforation 681. FIG. 15C shows the assembly 600 with the
cover 621
separated from the base 622. The strained dressing 630 may be applied to a
subject's skin using
the base 622 as an applicator.
FIG. 15D illustrates the back side 698 of the base 622 in a position of
applying the dressing
630 toward the skin of a subject. As shown, the edge 654 of attachment sheet
651 may be
wrapped around from the inside 694 of the base 622 to the back side 698 where
it is attached. A
tear strip may be attached to the attachment sheet 651 between the attached
edge and an
unattached middle section. The pull tab 688 or tear strip may be pulled to
detach the base 622
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from the remainder of the dressing assembly as shown in Fig 15E. After the tab
688 is pulled, an
unattached portion 651a of the attachment sheet 651 is freed from the base
622. After the base is
removed, the remaining portions of the attachment sheets 641, 651 may be
removed by peeling
the KAPTON tape off of the dressing 630. FIG. 15F shows the dressing 630
after removal of
the remainder of the dressing assembly.
FIGS. 15G to 15J illustrate a configuration of the dressing assembly 610 as
the KAPTON
tape or adhesive structures 670, 680 and attachment sheets 641, 651 are
removed from the
dressing 630. FIG. 15G and 15J show the orientation of the KAPTON tape or
adhesive
structures 670, 680 as they are peeled in a direction from inside the dressing
630 towards the
sides 633, 634 of the dressing 630, or in a direction of dressing strain. FIG.
15H shows the first
structure 670 peeled away from the inside of the dressing across the side 633
of the dressing. Fig
151 shows the first adhesive structure 670 removed from the dressing 630. The
second adhesive
structure 680 may be removed in a similar manner
FIGS. 16A to 16D illustrate an alternative dressing assembly 710 in a
configuration in
which a dressing assembly 710 is separated from the applicator or tensioning
device in a manner
similar to that described with respect to FIGS. 15A to 15J. FIG. 16A
illustrates a first adhesive
structure 770 and a second adhesive structure 780, each comprising KAPTON
tape or a
peelable adhesive structure used to attach attachment sheets 741, 751 to the
dressing 730, As
shown in FIG. 16A the unattached ends of the adhesive structures 770, 780 are
oriented away
from the dressing 730. As shown in FIG. 16B, the second adhesive structure 780
is peeled
inwardly and in FIG. 16C, is removed.
FIGS. 17A to 17D illustrate an alternative dressing assembly configuration in
which a
dressing assembly 810 is separated from the applicator or tensioning device in
a manner similar
to that described with respect to FIGS. 15A to 15J. FIG. 17D illustrates a
first adhesive structure
870 and a second adhesive structure 880, each comprising KAPTON tape or a
peelable
adhesive structure used to attach attachment sheets 841, 851 respectively to
the dressing 830. As
shown in FIGS. 17A and 17D, the adhesive structures 870, 880 are attached to
the dressing 830
with adhered length 891. An additional length 892 is wrapped 180 degrees about
the adhered
length 891. The additional length 892 has an end 893 that extends proud of the
dressing 830 for
easy access and removal. As shown in FIG. 17B, the first adhesive structure
870 may be pulled
using the end 893, in a direction that is in part perpendicular to the
direction of strain, to remove
the attachment structures 841, 851 and adhesive structure 870 from the
dressing 830 as further
shown in FIG. 17C.
FIGS. 18A to 181 illustrate a variation of a dressing and packaging assembly
900. The
packaging assembly 900 comprises an applicator and/or tensioning device 920
and a dressing
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assembly 910 including a dressing 930. The device 920 comprises a cover 921
and a base 922.
The dressing assembly 910 is removably coupled or anchored to the device 920
which may act
as a dressing carrier. The cover 921 may be generally planar and include sides
923, 924 with
corresponding edges 923a and 924a defining its length and edges 921a at
opposing ends. The
base 922 may be generally planar and include sides 925, 926 with corresponding
edges 925a and
926a defining its length and edges 922a at opposing ends.
The dressing assembly 910 also includes an attachment sheet 941and attachment
sheet 951.
The attachment sheet 941 has a first side 943 that is attached to the second
side 934 of the
dressing by way of an adhesive structure 970 such as KAPTON tape or a
peelable adhesive.
Adhesive structures herein may include but are not limited to KAPTONO tape or
peelable
adhesive configured to provide low skin trauma after repeated skin contact or
a soft skin
adhesive, made of material such as silicone adhesive, silicone gel, or acrylic
adhesive. The
adhesive structure or KAPTONR tape also comprises a material that is able to
adhere to the
attachment sheets to impart strain to the dressing when the attachment sheets
are separated from
each other, while being peelable from a selected dressing material.
As shown in FIG. 18J, the attachment sheet 941 and side 934 of the dressing
are attached
on same side 971 of the adhesive structure 970 with the attachment sheet 941
overlapping but
unattached to the dressing 931. The attachment sheet 941 has a second side 944
that is coupled
to the cover 921 of the device 920 for example, by bonding with a low surface
energy PSA such
as an acrylic adhesive. Attachment sheet 941 may also have a pull tab 981in an
unattached
region between the attachment to the adhesive structure 970 and attachment to
the cover 921.
After the dressing has been strained, the perforation pull tab 981 is located
at the inside surface
960 of the cover 921 or alternatively at the seam between the cover 921 and
the base 922.
The attachment sheet 951 is coupled at its side 954 to the back side 998 of
the base 922 for
example, by bonding with a low surface energy PSA such as an acrylic adhesive.
The side 953
of attachment sheet 951 is attached to the side 933 of the dressing 930 by way
of an adhesive
structure 980 such as KAPTONO tape or a peelable adhesive, and in a manner
similar to the
adhesive structure 970 that attaches the side 944 of the dressing 930 to the
attachment sheet 941.
The attachment sheet 951 may include a pull tab 988 that is located on the
back side 998 of the
base adjacent and inside of the attachment zone 955 of the attachment sheet
951 to the back of
the base 952.
According to some variations, the attachment sheets 941, 951 are flexible
while being
relatively inelastic with respect to the dressing 930 and may be constructed,
e.g., out of a LDPE.
The attachment sheets 941, 951 may be manufactured to be tearable along the
material length
while providing tensile strength in other directions, in particular in the
tensioning direction of the
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material of the attachment sheet 941(direction in which dressing is tensioned,
stressed or
strained). An example of such material is an LDPE polymer which is produced by
an extrusion
process that creates an anisotropic or directionally biased grain whereby the
material is tearable
with the direction of the grain, but has a relative resistance to tearing in
the direction transverse
to the grain.
The cover 921, when opened, exerts a straining force on the dressing 930
through the
attachment sheet 941. FIG. 18A shows the assembly 900 in an unstrained
configuration, while
FIG. 18B shows the assembly 900 in an opened and strained configuration which
may be applied
to the skin. As shown in FIG. 18C, when strained, the tab 981 on the
attachment sheet 941 is
located over the inner surface of the cover 921 (folded back and exposed) and
is accessible to a
user. After applying the dressing 930, the cover 921 and base 922 may be
removed.
The cover 921 and base 922 are separable from each when the tab 988 is pulled.
FIG. 18C
shows the assembly with the cover positioned with the dressing face down for
example as it
would be when applied to the skin of a subject. As shown in FIG. 18D the tab
988 is pulled to
release the cover 921 from the remaining dressing assembly 910. As shown in
FIG. 18E the
cover 921 is removed from the remainder of the device 920, exposing the second
pull tab 998.
As shown in Fig 18F, the second pulled tab 998 has released the base 922 from
the dressing
assembly 910 with attachment sheets 941, 951 unattached to the base 922. As
shown in Fig
18G, the base 922 is removed ant the remainder of the attachment sheets941,
951 and the
adhesive structures 970, 980 may be peeled away from the dressing 930 as shown
if FIG. 18H
with the dressing remaining on the skin in a configuration as shown in FIG.
181.
Referring to FIGS. 19A through 19D, a variation of a dressing and packaging
assembly
1000 is illustrated. The packaging assembly 1000 comprises an applicator
and/or tensioning
device 1020 and a dressing assembly 1010 including a dressing 1030. FIG. 19A
shows the
dressing assembly 1010 coupled to the applicator or tensioning device 1020.
The tensioning
member or applicator 1020 may be constructed in a similar manner as the
tensioning and
applicators described herein and shown in FIGS. IA to 22B.
The device 1020 comprises a cover 1021 and a base 1022. The dressing assembly
1010 is
removably coupled or anchored to the device 1020 which may act as a dressing
carrier. The
dressing assembly may be attached to the tensioning member or applicator in a
manner similar to
the assemblies described herein. The dressing assembly 1010 includes an
attachment sheet
1041and attachment sheet 1051. The attachment sheet 1041 has a first side 1043
that is attached
to the second side 1034 of the dressing 1030 by way of an adhesive structure
1070 such
described with reference to adhesive structures 970, 980. The attachment sheet
1041 has a
second side 1044 that is coupled to the cover 1021 of the device 1020 for
example, by bonding
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with a low surface energy PSA such as an acrylic adhesive. Attachment sheet
1041 also has a
ripcord 1088 stitched along its length at an unattached portion of the
attachment sheet 1041,
between its attachment to the adhesive structure 1070 and attachment to the
cover 1021. Various
types of stitches may be used including but not limited to a chainstitch or
alockstitch. After the
dressing has been strained, the ripcord 1088 is located at the exposed inner
side 1090 of the
cover 1021 or alternatively at the seam between the cover1021 and the base
1022.
The attachment sheet 1051 is coupled at its side 1054 to the back side of the
base 1022 for
example, by bonding with a low surface energy PSA such as an acrylic adhesive.
The side 1053
of attachment sheet 1051 is attached to the side 1033 of the dressing by way
of an adhesive
structure 1080 such as KAPTONO tape or a peelable adhesive, and in a manner
similar to the
adhesive structure 1070 that attaches the side 1034 of the dressing 1030 to
the attachment sheet
1041. The attachment sheet 1051 includes a ripcord 1098 that is located
between attachment to
the adhesive structure 1090 and attachment to the back of the base. The ends
of the ripcords
1088, 1098 extend out of the tensioning member 1020 for easy accessibility.
FIGS. 19A and 19B illustrate the dressing assembly 1010 in an unstrained
configuration.
The cover 1021, when opened, exerts a straining force on the dressing 1030
through the
attachment sheet 1041. FIG. 19C illustrates the dressing assembly 1010 in a
strained
configuration.
After the dressing is strained and applied, the ripcords 1088, 1098 are pulled
to separate
the portion of the attachment sheets 1041, 1051 attached to the tensioning
device 1020 from the
portions of the attachment sheets 1041, 1051 attached to the dressing 1030.
The applicator or
tensioning device 1020 may then be removed as shown in FIG. 19D. The adhesive
structures
1080, 1090 may then be peeled away to remove the remaining portion of the
dressing assembly
1010 and attachment sheets 1041, 1051, from the dressing as shown in FIG. 19E.
Referring to FIGS. 20A to 20C, a variation is shown of a dressing carrier,
tensioning
device or applicator 1120. The device 1120 comprises a plurality of segments
1130 formed by
scoring a substrate 1150 on one side 1155 of a planar surface. The scores 1170
may be formed
in one or more directions or having one or more shapes, curved or straight.
Additionally the
scores may be formed on both sides permitting both convex and concave shaping
of a device.
As illustrated, the scores 1170 permit shaping of the device or an attached
dressing. The scores
1170 as illustrated are formed on a first side 1155 of a planar surface of the
device while the
second side 1165 is not scored. When a force is applied to the second side
1165, the substrate
bends. When a force is applied to the first side 1155, the substrate 1150 the
device does not flex
at the scores 1170. The remaining substrate at the scores 1170 may act as
flexion limiter while
the scores 1170 act as a flex element.
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When a convex dressing shape is desired for a concave surface, the dressing
may be
attached on the first side 1155 so that when the substrate is bent, the
dressing forms a convex
shape to match a concave contour where the device is to be applied. When a
concave dressing
shape is desired for a convex body contour, the dressing may be positioned on
the second side
1165 of the substrate 1150. So that when the substrate is bent, the dressing
forms a concave
shape to match a convex body contour where the device is to be applied.
Various dressing
backings may be provided for different body locations or contours.
According to variations, the score may be orthogonal or have orthogonal
components with
respect to the segments 1127 of the carrier, applicator or tensioning device.
The segments 1127
may be similar to segments shown in FIGS. 1A to 22B.
Referring to FIGS. 21A to 21D, a variation is shown of a dressing carrier,
tensioning
device or applicator 1220. The device 1220 comprises a plurality of foam cells
1240 coupled by
and adhesive backing1260. The foam cells 1240 form a plurality of segments
1227 that permit
flexing in multiple directions so that the device conforms to a curvature,
profile or shape of a
subject where the dressing is to be applied. The foam may be sufficiently
thick to generally
provide added column strength for straining a dressing, i.e. a resistance to
bending. A backing or
support may be provided for straining a dressing, for example constructed of a
material with an
elastic modulus and appropriate thickness that will, at minimum, counteract
the force created by
straining the dressing. The dressing strain may be fixed, for example, using
an adhesive on the
back of a portion of the dressing assembly or attachment sheet. After the
dressing is fixed, the
backing or support may be removed permitting increased manipulation of the
shape of the
strained dressing to conform to a greater degree to the shape of the patient's
body contours
where the dressing is to be applied.
As illustrated, the separations 1270 between the foam sections permit shaping
of the
device. The separations 1270 as illustrated are formed on a first side 1255 of
a planar surface of
the device while the second side 1265 is not scored. When a force is applied
to the first
side1255, the substrate bends. When a force is applied to the second side1265,
the substrate
1250 the device does not flex at the separations. The remaining substrate at
the separations may
act as flexion limiter while the scores act as a flex element.
When a convex dressing shape is desired for a concave surface, the dressing
may be
attached on the first side 1255 so that when the substrate is bent, the
dressing forms a convex
shape to match a concave contour where the device is to be applied. When a
concave dressing
shape is desired for a convex body contour, the dressing may be positioned on
the second side
1265 of the substrate 1250. So that when the substrate is bent, the dressing
forms a concave
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shape to match a convex body contour where the device is to be applied.
Various dressing
backings may be provided for different body locations or contours.
Referring to FIGS. 22A and 22B, a variation of a dressing and packaging
assembly 1500 is
illustrated. The packaging assembly 1500 comprises an applicator and/or
tensioning device 1520
and a dressing assembly 1510 including a dressing 1530. The packaging assembly
1500,
applicator or tensioning device 1520, and/or dressing assembly 1510 may be
configured to pre-
strain the dressing 1530 and/or permit transfer of the pre-strained dressing
1530 to the skin of a
subject.
The device 1520 may comprise a cover 1521 and a base 1522. The dressing
assembly
1510 is removably coupled or anchored to the device 1520, and may serve as a
dressing carrier.
The cover 1521 and base 1522 are movably, pivotably, bendably or hingedly
coupled at sides
1523, 1524 and may be constructed in a manner similar to that described with
respect to covers
and bases described in FIGS. 1A to 22B. Attachment regions 1541, 1551 of the
dressing
assembly 1510 are attached near free sides 1525, 1526 of cover 1521, 1522
respectively, for
example by way of a peelable adhesive or removable adhesive structures.
However an
attachment sheet or attachment structure described with respect FIGS. lA to
22B herein may be
used. The attachment regions 1541, 1551 and or positioning of the dressing
1530 on the device
1520, may be symmetric with respect to a line defined by attachment of sides
1523, 1524 of the
cover 1521 and base 1522 respectively. As shown in FIG. 22B, the dressing 1530
is strained
with the cover 1521 and base 1522 are opened. The dressing 1530 may then be
applied to the
skin of a subject and the device 1520 may be peeled away from the dressing
1530. In addition or
alternatively, the cover 1521 and base 1522 may be separated by way of a
perforation formed in
the substrate of the device 1520 or a perforation 1551 formed in an attachment
structure 1550
such as a tape or layer of material that attaches sides 1523 and 1524 of the
cover 1521 and base
1522 respectively.
In some variations, the device 1520 may optionally comprise an adhesive
coating or
adhesive tape on the cover 1521 and/or base 1522 which may adhere to the
dressing 1530 when
the dressing 1530 is tensioned and the dressing comes in further contact with
the cover 1521 and
base 1522. In some variations, the adhesive is configured to maintain the
dressing 1530 in a
tensioned state and/or against the cover 1521 and/or base 1522. The adhesive
coating or
adhesive tape may be located along the side regions 1523, 1524 of the cover
1521 and/or base
1522, but many also be provided adjacent to the attachment regions 1541, 1551.
Release liners
may also be provided to reduce inadvertent adhesion of the dressing or other
structures to the
adhesive until activation of the device 1520 is desired.
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According to variations the various assemblies or devices described herein may
provide a
temporary wound dressing that may be applied before a wound is closed. The
assembly may be
configured to apply a dressing to a wound and to use the packaging or
applicator to apply
pressure to the wound before removing or separating the applicator, tensioning
device or
dressing carrier, base or support from the dressing. According to this
variation which may be
provided with any of the embodiments described below, the packaging or
applicator has
sufficient rigidity to distribute a relatively even or firm force to a wound
by applying pressure to
the packaging or applicator when and/or after the dressing is applied to a
wound. According to a
variation, such dressing may include a coagulation agent or other agent or
medicament, for
example as described herein. According to another variation, margins as
described herein, are
provided on such a device between a dressing and edges used to manipulate the
device.
The assemblies or devices described herein may also form a dressing support
structure.
For example, the dressing support structure may comprise of a plurality of
segments of the base
structures. The dressing support structure may comprise at least 3 segments
that extend at least
from a first side of the dressing to a second side of the dressing. The
dressing support structure
may comprise a plurality of segments such as segments described in FIGS. 1A to
22B that are
coupled or formed together. The plurality of segments of a cover described
herein may also
provide support to a dressing when the cover is folded over 360 degrees with
respect to the
corresponding base structure.
In other examples, the strained dressing may be provided to the user as pre-
strained
dressing that is strained at the point-of-manufacture, rather than at the
point-of-use. Referring to
FIGS. 23A to 231, preparation of a pre-strained assembly 2351 that includes a
pre-strained
dressing is illustrated. A tensioning device 2341 used to prestrain the
dressing is shown in use
in FIGS. 23A to 23D. Various features and stages of preparing prestrained
assembly 2351 are
further shown in FIGS. 23E to 231.
The pre-strained assembly 2351 may comprise a dressing assembly 2308 and
strain
maintaining structure or support structure 2330. (See Fig. 231) The pre-
strained assembly 23M
may be stored for a period of time prior to use.
The dressing assembly 2308 may include a dressing 2310 comprising a relatively
planar
elastic sheet 2360 defining a plane. The elastic sheet 2360 may comprise a
silicone sheet or
other elastic material, for example, as described herein. The dressing
assembly 2308 may further
comprise an attachment sheet 2304, tensioning sheet 2307, a pre-strained
assembly release 2352
and a dressing release 2319.
The attachment sheet 2304 may be configured to attach the dressing 2310 to a
support
structure 2330 by way of engaging element 2322. The attachment sheet 2304 of
the dressing
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assembly 2308 may include a first engaging wall or element 2322 extending
downward with
respect to the plane of the dressing 2310 and including an inwardly extending
hook 2323.
Engaging element 2322 may be attached to the attachment sheet 2304, for
example, with an
adhesive. The tensioning sheet 2307 of the dressing assembly 2308 may include
a second
engaging element 2324 extending downward with respect to the plane of the
dressing 2310 and
including an inwardly extending hook 2325. The tensioning sheet 2307 may be
configured to
attach the dressing 2310 to the support structure 2330 by way of engaging
element 2324.
Engaging element 2324 may be attached to tensioning sheet 2307, for example,
with an
adhesive. The tensioning sheet 2307 may also be configured to translate
tension from the
tensioning device 2341 to the dressing 2310 to strain the dressing 2310.
The pre-strained assembly release 2352 may be configured to release the pre-
strained
assembly 2351 (the dressing 2310 and support structure 2330) from the
tensioning device 2341
(see, e.g., Figs 23E and 231). The dressing release mechanism 2319 may be
configured to
release the dressing 2310 from the engaging elements 2322, 2324 (including
hooks 2323, 2325)
and thus from the support structure 2330. The dressing release mechanism 2319
may be
configured to release the dressing 2310 after the dressing 2310 is applied to
a subject.
The dressing 2310 of the dressing assembly 2308 may have a first edge or side
2305
having a length, and a second edge or side 2306 having a length. The dressing
2310 may be
coupled at a first edge or side 2305 to the attachment sheet 2304 which may be
flexible yet
relatively less elastic or in-elastic than the dressing 2310. The attachment
sheet 2304 may have
a first side 2382 and a second side 2384. When assembled, the attachment sheet
2304 may be
bonded to the elastic sheet 2360 of the dressing 2310 at section 2375 of
attachment sheet 2304 at
or near the side 2382 of the attachment sheet 2304, for example, using a
combination of a
silicone PSA/acrylic PSA. The attachment sheet 2304 may be coupled at its side
2384 to
engaging element 2322 and hook 2323, for example, by bonding with an adhesive
material, e.g.,
using a combination of a silicone PSA/acrylic PSA. The attachment sheet 2304
may couple the
dressing 2310 by way of engaging element 2322 and hook 2323, to the support
2330 near the
first side 2305 of the dressing 2310. The dressing 2310 may be coupled at its
second edge or
side 2306 to the tensioning sheet 2307 which may be flexible yet non-elastic
or less elastic than
the dressing 2310. The tensioning sheet 2307 may have a first side 2372 a
middle location 2373
and a second side 2374. When assembled, the tensioning sheet 2307 may be
bonded to the
elastic sheet 2360 of the dressing 2310 at section 365 of tensioning sheet
2307 at or near the side
2372 of the tensioning sheet 2307, for example, using a combination of a
silicone PSA/acrylic
PSA. The tensioning sheet 2307 may be coupled at a middle location 2373 to
side wall 2324 and
hook 2325, for example, by bonding with an adhesive material, for example,
using a
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combination of a silicone PSA/acrylic PSA. When assembled into the pre-
strained assembly
2351, the tensioning sheet 2307 may couple the dressing 2310 by way of side
wall 2324 and
hook 2325 to the support structure 2330 near the second side 2306 of the
dressing 2310. The
tensioning sheet 2307 may be loaded onto the tensioning device 2341 at the
second side 2374 as
described in more detail herein. According to some variations, the attachment
sheet 2304 or
tensioning sheet 2307 may be constructed, e.g., out of a low density
polyethylene.
The dressing assembly 2308 is shown in FIG. 23A, positioned over a support
structure
2330 to which it may be removably attached when or after the dressing 2310 is
pre-strained to
form the pre-strained assembly 2351. The support 2330 may be generally planar
and include
sides 2335, 2336 with corresponding edges 2335a and 2336a defining its length.
Other support
elements, support structures and/or strain maintaining elements may be used,
for example, the
sides of the dressing 2310 or dressing assembly 2308 may be clamped and a
desired distance
maintained between the clamps, e.g., using a separating element.
The dressing 2310 of the dressing assembly 2308 may be strained, for example,
with a
tensioning device 2341 as shown in Figs 23A to 23D. The pre-strained dressing
2310 may then
be stored in a pre-strained configuration for a period of time prior to use.
The tensioning device
2341 may be used at a point of manufacture, by an intermediary, or by an end
user. The
tensioning device 2341 may comprise a planar portion 2343 and a circular
portion 2344
configured to contain a rotating element 2345. The rotating element 2345 may
have a middle
section 2346 with a slot 2347 to receive and engage the tensioning sheet 2307
of the dressing
assembly 2308.
In FIGS. 23A the dressing assembly 2308 may be shown in a first configuration
on the
tensioning device 2341 where it is relatively unstrained. The dressing
assembly 2308 may be
positioned over support structure 2330. This support structure 2330 may be
positioned over the
tensioning device 2341 with the upper surface 2333 of the support structure
2330 interfacing the
back side 2311 of the dressing 2310. A first edge 2335a of the support
structure 2330 and a first
side or edge 2349 of the planar portion 2343 of the tensioning device 2341 may
be engaged and
held by engaging wall 2322 and hook 2323. The second end 2336 and edge 2336a
of the support
2330 may initially be free from engagement with but is in a position
interfacing the dressing
2310. This may permit the dressing 2308 to be strained to a desired degree
without interference
of the support structure 2330.
In use, the end 2374 of the tensioning sheet 2307 may be inserted into the
slot 2347 in the
middle section 2346 of the rotating element 2345 of the tensioning device
2341. Then the
rotating element 2345 may be rotated until the tensioning sheet 2307 is
engaged. Initially the
tensioning sheet 2307 and dressing 2310 may be in an unstrained configuration
but with minimal
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slack, when attached to the tensioning device 2341. As the rotating element
2345 is rotated, the
dressing 2310 may be strained as the tensioning sheet 2307 is pulled in a
tensile straining
direction with respect to the dressing 2310 by the rotating element 2345.
The dressing 2310 may be strained by turning the rotating element 2345 as
shown in FIGS.
23A-23D. Once the tensioning sheet is loaded as the rotating element 2345 is
turned, the
tensioning sheet 2307 may wrap around the rotating element 2345 thereby
shortening the
distance between the rotating element 2345 and the dressing 2310, to stretch
or strain the
dressing 2310. A locking mechanism comprising ratchets 2337 on the rotating
element 2345 and
a pawl 2338 on the circular portion 2344 may be used to lock the dressing 2310
in a strained
configuration as shown in FIGS. 23B to 23D. When the tensioning sheet 2307 is
pulled in a
tensile straining direction towards the circular portion 2344 of the
tensioning device 2341, the
engaging element 2324 and hook 2325 may also move in the tensile straining
direction. The
edges 2336a of the support comprises a ramp 2336b that may engage with a ramp
2326 on the
hook 2325 to guide the edge 2336a of the support 2330 into engagement with the
hook 2325 as
the hook 2325 moves towards the circular portion 2344 of the tensioning
device. (See FIGS.
23C to 23H). The strain of the pre-strained dressing 2310 may be controlled or
determined using
measurement elements or marks 2342 on the rotating element 2345 the distance
between each of
which may correspond to an increment of increased strain or distance. Once a
dressing assembly
2308 is loaded on the tensioning device 2341, the strain may be determined by
the amount the
rotating element 2345 rotates. Each mark 2342 may correspond to a percentage
strain or a
distance. A 0% strain may be identified as the position in which the dressing
assembly 2308 is
loaded onto the tensioning device 2341 with no slack and minimal strain or
tension. As shown in
Fig 23A the 0% position may be shown where mark 2342a is aligned with the pawl
2338. As
the rotary element 2345 is rotated, the identified 0% mark 2342a may rotate a
certain degree
which corresponds to a percent strain. Mark 2342b as shown in FIG. 23B is
aligned with the
pawl 2338 when the dressing is strained to a desired amount x indicated by
mark 2342b.
The support structure 2330 may maintain the dressing 2310 in its strained
configuration as
shown in FIGS. 23B to 231 during storage where the engaging elements 2322,
2324 and hooks
2323, 2325 engaging the support structure 2330, prevent movement of the
dressing 2310 or loss
of strain. One or more adhesive regions comprising a layer of skin adhesive
2340 may be
applied to the top surface 2312 of the dressing 2310. The adhesive 2340 used
may be, for
example, a suitable pressure activated adhesive (PSA), or a non-pressure
sensitive adhesive.
The adhesive 2340 is shown on a dressing 2310 in an unstrained configuration.
However, the
adhesive may be applied to the dressing 2310 after the dressing 2310 has been
strained. A
removable liner 2350 may be placed over the adhesive layer 2340. The liner
2350 may further
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be selected to maintain the strain in the dressing 2310. Such liner may
comprise rigid or semi-
rigid material, for example, ultra-high molecular weight polyethylene (UHMWPE)
with a release
coating or layer, e.g., a fluoropolymer such as perfluoroalkoxy (PFA),
fluorinated ethylene
propylene (FEP), polytetrafluoroethylene (PTFE) or expanded PTFE (ePTFE).
Other hard
plastics or resins that may be used include melamine, fiberglass,
acrylonitrile butadiene styrene
(ABS) or polyvinyl chloride (PVC). In other variations, the rigid liner may be
a composite
structure comprising a flexible liner with a rigid frame or rigid struts,
which may comprise, for
example, a metal (e.g. stainless steel), or a hard plastic/resin.
Once the dressing 2310 is strained and the dressing assembly 2308 may be
secured in
engagement with the support structure 2330, the dressing assembly 2308 and
support structure
2330 may be separated from the tensioning device 2341 to form the pre-strained
assembly 2351
that may be used immediately or stored for a period of time.
The pre-strained assembly release 2352 may comprise a tear strip 2353 that is
attached to
the tensioning sheet 2307 between the middle location 2373 and the second side
2374 with upper
and lower portions 2354, 2355 respectively (See Fig. 23E). The tear strip 2353
may act to
separate the pre-strained assembly 2351 from the tensioning device 2341 by
tearing across the
tensioning sheet 2307 between the pre-strained assembly 2351 and the
tensioning device 2341.
In use, after the liner 2350 is released, the dressing 2310 may be applied to
a desired
location on a subject's skin. The user may apply pressure to the back side
2333 of the support
2330 to activate the adhesive on the dressing 2310 and/or to apply compression
to a wound.
Once applied to a subject, the dressing 2310 may be released from the support
2330 using the
release mechanism 2319.
The release mechanism 2319 may comprise tear strips 2309. The tear strips 2309
of the
release mechanism 2319 may each extend proud of the end 2366 of elastic sheet
2360. The tear
strips 2309 may each be coupled to the dressing assembly 2308. A tear strip
2309 may be
coupled to the attachment sheet 2304 of the dressing assembly 308 in a manner
that defines tear
path 2362 along which the tear strip 2309 is pulled to separate the dressing
2310 from the
support 2330. A tear strip 2309 may be coupled to the tensioning sheet 2307 of
the dressing
assembly 2308 in a manner that defines tear path 2362 along which the tear
strip 2309 is pulled
to separate the dressing 2310 from the support 2330. Each tear strip 2309 may
comprise a top
section 2347 and bottom section 2348. The bottom sections 2348 may be
unattached or free
from the support 2330 as illustrated. The top sections 2347 of each tear strip
2309 may be
adjacent but unattached to the dressing 2310. The tensioning sheet 2307 and
attachment sheet
2304 may be manufactured to be tearable along the material length while
providing tensile
strength in other directions, in particular in the tensioning direction of the
material of the
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tensioning sheet 2307 (direction in which dressing is tensioned, stressed or
strained) An example
of such material is an LDPE polymer which is produced by an extrusion process
that creates a
directionally biased grain whereby the material is tearable with the direction
of the grain, but has
a relative resistance to tearing in the direction transverse to the grain.
Notches may be made in
the tensioning sheet 2307 and attachment sheet 2304 that facilitate tearing
along paths 2362. The
tensioning sheet 2307 and attachment sheet 2304 may additionally or
alternatively comprise a
material such as a low-density polyethylene (LDPE) with perforations formed
along tear lines
2362.
The dressing 2310 may be released from the support 2330 by pulling the tear
strips 2309 to
draw the tear strips across paths 2362 of the tensioning sheet 2307 and
attachment sheet 2304.
Sections 2365 and 2375 respectively of the tensioning sheet 2307 and
attachment sheet 2304
may remain on the back side 2311 of the elastic sheet 2360. The sections 2385,
2395
respectively, of the attachment sheet 2304 and tear sheet 2307 bonded to the
tear strips 2309 may
thereby be separated from the tensioning sheet 2307 and attachment sheet 2304.
The sections
2365 and 2375 respectively of the tensioning sheet 2307 and attachment sheet
2304 that are
attached to the dressing 2310 may thereby be separated from the remainder of
the tensioning
sheet 2307 and attachment sheet 2304 that are attached to the support
structure 2330 at its ends
2305 and 2306. Thus, the dressing 2310 may be released from the remainder of
the support
structure 2330.
The dressing 2310 may have unattached portions or edges 2315 at its sides
2305, 2306
where the elastic sheet 2360 is free from the tensioning sheet 2307 and
attachment sheets 2304
respectively. Accordingly, the dressing 2310 may be unstrained at unattached
portions 2315.
Unattached sections 2315 of the elastic dressing 2310 may be unstrained and
may be free from
the adhesive of the adhesive layer 340 (or may have a reduced amount of
adhesive thereon).
Thus less stress may occur at the unattached sides or edges defined by
sections 2315.
In use, the adhesive liner 2350 may be removed and the dressing 2310 applied
to the
surface of a subject's skin. Tear strips 2309 on each side of the dressing at
tear lines may be
pulled to separate the dressing 2310 from the support structure 2330,
attachment sheet 2304 and
tensioning sheet 2307, after the dressing is applied to the surface of skin of
a subject. When the
support structure 2330, attachment sheet 2304 and tensioning sheet 2307 are
removed from the
dressing 2310, the stress or strain of the dressing 2310 may apply a
(tangential) compressive
force to the skin to thereby treat the skin.
Referring to FIG. 24, a plurality of strained dressings 2410 may be strained
in a manner
similar to dressing 2310 and then may each be attached to a first surface 2460
of single support
2430 which is rolled and stored in a rolled configuration for dispensing as
shown in FIG. 24.
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The strained dressings 2410 may be coupled to the first surface 2460 of the
single support 2430
by an adhesive, such as, e.g., a high tack/low peel PSA, which maintains the
dressings 2410 in a
strained configuration. Liners 2450 may be placed on a second and opposite
side 2470 of the
support 2430 and are positioned so that when the support 2430 is rolled, they
are over a skin
adhesive on the top of the dressings 2410. The adhesive liner 2450 may also
help minimize
creep properties of the strained dressings 2410. The support 2430 may be
rolled to store the
dressings 2410. When the support 2430 is unrolled, the adhesive liner 2450
positioned on the
second side 2470 and opposing a dressing 2410 may release from the dressing
2410. Dressings
2410 may be separated by a perforation 2480 so that they may be individually
used.
In some variations, the dressing may be used for the treatment of chronic
injection sites or
catheter sites that are required for a variety of conditions, including but
not limited diabetes,
cancer, immune disorders such as severe combined immunodeficiency disease, and
the like. It is
hypothesized that treatment of skin injection/infusion sites may not only
reduce the development
of scar tissue or other hyperproliferative disorders associated with frequent
injections or chronic
infusions, but may have other mechanical effects on pharmacokinetics, that may
improve drug
dispersion in the tissue, reduce drug leakage, increase the depth of effect,
reduce pain at the
injection/infusion site, reduce site infection risk, reduce risk of line/pump
occlusion at an
infusion site, improve analyte or drug level variability, reduce inflammatory
layer thickness or
depth, reduce dosing level. For diabetes patients, the skin treatment may
result in fewer
glycemic excursions, improved time-in-range as measured by multiple daily
fingerstick or
continuous glucose monitoring (CGM), increased insulin bolus volume and/or
area in the
subcutaneous tissue.
In other variations, the tensioned tissue treatments described herein may be
also be used to
treat subdermal or subcutaneous tissue conditions, which may result from
injection, infusions or
implants. In one example, the tensioned tissue treatment system may be applied
to the insertion
site of a drug-eluting oral contraceptive implant, such as the NEXPLANON
etonogestrel
implant (Merck, Whitehouse Station, NJ). This implant is a radiopaque, soft,
flexible progestin
eluting implant that consists of ethylene vinyl acetate (EVA) copolymer core
that has been doped
with barium sulfate to provide radio-opacity, with 68 mg of progestin
etonogestrel that is
released for up to three years. Difficulties or complications with the removal
of the implant have
been reported in 1.5% of cases, with encasement of the implant in fibrotic
tissue being the most
common cause. It is believed that treatment of insertion site and final
implant location with a
tensioned tissue treatment system may reduce the development of fibrotic
tissue surrounding the
implant, which may reduce the complication rate during the explantation
procedure. Fat atrophy
at the subdermal contraceptive implant site has been known to lead to loss of
contour, with a
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significant aesthetic impact. Fat atrophy local to subdermal contraceptive may
be due to any of
the components in the implant acting directly on surrounding fat cells or by
means of foreign
body type reaction. Injection site nodule formation in the subcutaneous layer
is another common
reaction to diabetes drug treatment injections such as GLP-1 (i.e. exenatide)
agonist therapy used
by T2D patients. Paresthesias, pain, and blot clot risk at the implantation
site may also be
reduced during the three-year treatment period with the implant whether or not
fibrotic tissue
development is reduced. In some variations, the tensioned tissue treatment
device may be
applied to the implantation site for the entire duration of the implantation,
but in other variations,
tensioned tissue treatment may be applied for a period of time in the range of
4 to 6 weeks, 4 to 8
weeks, 6 to 8 weeks, 6 to 12 weeks after implantation, or following
explantation. In some
further variations, treatment may be applied to the proposed implantation site
4 to 6 weeks, 4 to 8
weeks, 6 to 8 weeks, 6 to 12 weeks prior to implantation. This may reduce or
break up existing
fibrosis or otherwise cause the tissue to remodel pre-implantation, and
facilitate the implantation
procedure and facilitate promote post-implantation healing and other tissue
responses. An initial
limited period of treatment may be sufficient to alter or slow the initial
tissue remodeling process
or inflammation to reduce the adverse reactions associated with the
implantation. The user may
be instructed to place the tensioned dressing to cover the skin area that is
at least 1 cm, 2 cm, or 3
cm or more surrounding the implant. The direction of tension of the dressing
may be oriented
along or transverse to the longitudinal axis of the implant.
The implant may also be an injectable material, such as a depo formulation of
an injectable
contraceptive like DEPO-PROVERA (Pfizer, New York, NY), a medroxyprogesterone
acetate
formulation with a polyethylene glycol and polysorbate carrier that is
injected every three
months. Drug levels peak 3 weeks after injection and become undetectable
between 120 to 200
days post-injection.
Another depo injection is SUBLOCADE (INDIVIOR, North Chesterfield, VA), a
monthly depo formulation of buprenorphine for the treatment of opioid use
disorder for patients
who are undergoing treatment with another buprenorphine product. SUBLOCADEO is
intended
to be injected subcutaneously at a rotating abdominal site, free of skin
conditions, between the
transpyloric and transtubercular plane of the abdomen. Phase 3 studies of
SUBLOCADEO found
a 16.5% rate of injection site reactions, which included, pain, itching,
redness, bruising, swelling,
induration, cellulitis and other discomfort.
In another example, an injectable oncology therapy agent may also be treated.
For
example PHESGOO (Genentech, South San Francisco, CA), a combination therapy of
pertuzumab and trastuzumab monoclonal antibodies with recombinant human
hyaluronidase for
the treatment of HER2+ breast cancer. PHESGOC may be used in conjunction with
a tensioned
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skin dressing, to modulate drug levels and/or to reduce injection site
reactions such as pain,
itching.
In still other variations, the tensioned tissue treatment system may be used
in conjunction
with injectable therapies for autoimmune or inflammatory disorders, including
but not limited
rheumatoid arthritis, psoriasis, lupus, and the like. Subcutaneous injections
may include disease-
modifying anti-rheumatic drugs (DMARDs) such as methotrexate, weekly
subcutaneous
injectable ACTEMRA (tocilizumab)(Genentech, South San Francisco, CA) for
treatment of
rheumatoid arthritis, giant cell arteritis, cytokine release syndrome,
juvenile idiopathic arthritis
and systemic sclerosis-associated interstitial lung disease, ever four week
subcutaneously
injectable ILARISO (Canakinumab)(Novartis, East Hanover, NJ) for treatment of
periodic fever
syndrome, TNF receptor associated periodic fever, hyperimmunoglobulin D
syndrome
(HIDS)/mevalonate kinase deficiency, Still's disease, and juvenile idiopathic
arthritis, every two
weeks subcutaneous injectable KEVZARAR(IL-6 receptor agonist)(Sanofi,
Bridgewater, NJ) in
combination with methotrexate or other convention disease-modifying anti-
rheumatic drug for
the treatment of severe rheumatoid arthritis,
Treatment with a tensioned skin dressing may be provided continuously during
use of the
depo injections above, or for a limited period of time following each
injection, e.g. 3 to 5 days, 3
to 7 days, 5 to 10 days, or 7 to 14 days post-injection. The dressing may
contain apertures to
facilitate a rotational injection patterns with therapeutic agents require
multiple serial injections.
Although the particular example above involves a drug eluting device, in other
variations,
the implant may be a non-drug eluting implant, e.g. cosmetic body
modifications including but
not limited to dermal or subdermal beads, rods or horns, or therapeutic
implants such as a hyoid
bone implant for treatment of obstructive sleep apnea. For implants intended
for extended or
undefined treatment durations, tensioned tissue treatment may be applied for a
period of time in
the range of 4 to 6 weeks, 4 to 8 weeks, 6 to 8 weeks, 6 to 12 weeks after
implantation. Fibrous
capsule formation may occur around implants during the end-stage healing
response.
Eventually, atrophy may occur due to diminished blood supply. It is
hypothesized that the
tensioned dressing may have an effect on the fibrous capsulation. This may
include a reduction
in the final size and/or the pliability, compared to untreated controls.
The injectable material may also be an autologous fat, or a cosmetic fillers
such as
JUVEDERM (Allergan Aesthetics, Madison, NJ), RADIESSE (Merz, Franksville,
WI),
RESTYLANE (Galderma, Fort Worth, TX), whether injections are performed using
a needle
or a flexible blunt-tipped microcannula, such as the DERMASCULPT MICROCANNULAO
by
CosmoFrance (Miami, FL), PIX'L cannula by Thiebaud (Paris, France) and Merz
cannulas by
TSK Labs (Tochigi, Japan). Use of a tensioned skin dressing over the injection
site(s) may
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reduce the swelling and/or bruising that may occur. Tensioned skin dressing
may be applied for
3 to 5 days, 5 to 7 days, 7 to 10 days, 3 to 7 days, or 7 to 14 days post
injection, with the
tensioned skin dressing reapplied with each injection of the treatment
regimen. In some
variations, the tensioned dressing may be indicated only with the onset of the
local size adverse
reactions, or may be applied preventatively, to reduce the risk or rate of
onset of such adverse
reactions. Treatment of dermal filler injection at the subcutaneous junction
via threading or
tunneling techniques may reduce visibility of the injection tract by reducing
scar formation along
the tract and/or migration of the filler location. Treatment with cosmetic
fillers with a tensioned
skin dressing may be provided for a limited period of time following each
injection, e.g. 3 to 5
days, 3 to 7 days, 5 to 10 days, or 7 to 14 days post-injection. The tensioned
skin dressing may
be sized to ensure coverage of the injection area(s) by at least a 1 cm, 2 cm
or 3 cm margin. In
some variations, the direction of tension in the skin dressing may be selected
to be generally
transverse to the direction or average directions of the threading or
tunneling injection paths. It
is hypothesized that the tensioned tissue treatment may reduce the chance of
ecchymosis that
may result from increased tissue resistance during insertion of microcannulas,
when the tension
off-loading dressing therapy is used prior to injections and existing fibrosis
has been pre-treated
and/or reduced. Additionally, tolerability of the procedure and treatment
compliance may
increase if the patient's discomfort level has decreased due to reduced scar
tissue build-up.
Patients have reported discomfort from insertions in scar tissue causing pain
and noise of a blunt
cannula passing through hard dense scar tissue.
In other variations, tensioned tissue treatment described herein may be
provided for, or
used with, a variety of infusion devices that may be used for various
therapeutic and/or
diagnostic procedures. These include intradermal infusion devices,
subcutaneous infusion
devices, and intravascular implantable infusion ports. These infusion devices
may be used, for
example, to provide insulin infusion for the treatment of diabetes,
intravenous immune globin or
subcutaneous immune globin infusion for the treatment of immune deficiency
syndromes,
chemotherapy infusions for the treatment of a variety of cancers, and the
like. In some of the
embodiments described below, the tensioned tissue treatment system may be
integrated with or
specifically tailored to the infusion device, but in other variations, the
tensioned tissue treatment
device may be applied in between infusions or injections, or for a specific
period of time after
each infusion or injection. As described in greater detail below, the use of
tensioned tissue
treatment may reduce, slow or prevent the development of intradermal scar
tissue, which may
improve or slow the rate of change in absorption or diffusion kinetics of any
intradermal or
subcutaneous injections or infusions, and/or may reduce the development of
chronic pain or
paresthesias resulting from repeated tissue trauma from the injection or
infusion. Examples of
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such devices include the SAF-Q and OPTIFLOW infusion sets and SCIG60 infusion
pumps by
EMED Technologies (El Dorado Hills, CA), the PORT-A-CATH implantable venous
access
systems by Smiths Medical (Dublin, OH), the INSUFLON multi-injection
subcutaneous catheter
by Unomedical (Roskilde, Denmark), and the I-PORT ADVANCE injection port by
Medtronic
MiniMed (Northridge, CA). Tensioned tissue treatment may be applied for a
period of time in
the range of 4 to 6 weeks, 4 to 8 weeks, 6 to 8 weeks, 6 to 12 weeks after
implantation of such
devices, and/or for 3 to 5 days, 5 to 7 days, 7 to 10 days, 3 to 7 days, or 7
to 14 days after each
injection. For infusion systems adhered to the skin, the tensioned tissue
treatment systems
described herein may be applied first, and then the infusion system is
inserted through an
aperture in the tensioned tissue treatment device. Use of the tensioned tissue
treatment system
may improve, reduce and/or prevent the risk of catheter or port erosion
through the skin, catheter
occlusion, device migration or rotation, device extravasation, fibrin sheath
formation, injection,
inflammation, necrosis or hyperpigmentation over the implant area, pain at the
port pocket site,
catheter tip malposition or retraction, insertion vessel erosion, and/or
vascular thrombosis.
In another embodiment, the tensioned tissue treatment system is used in
conjunction with
hemodialysis procedures and applied to the needle insertion sites of the
dialysis graft or fistula.
In some variations, a single tensioned tissue treatment device may be applied,
covering both
needle insertion sites, while in other variations, two tensioned tissue
treatment devices are used,
one for each needle insertion site. In these embodiments, the direction of the
tension applied to
the arm of the hemodialysis patient may be along the longitudinal or the
transverse direction of
the arm. It is hypothesized that the use of tensioned tissue treatment at the
hemodialysis needle
insertion sites may reduce the risk of developing pain, ulceration and/or
tissue calcification in the
dermal and/or subcutaneous tissue overlying the graft or fistula. In another
example, use of
tensioned tissue treatment on patients that are not eligible for an AV fistula
due to excessive scar
tissue build up from previous IV, blood work, or medication, may remodel
tissue sufficiently to
allow for the fistulization procedure. In some further variations, the
tensioned tissue treatment
may even reduce the rate of thrombosis of a fistula by reducing short-term
inflammation at the
insertion site, or mechanical stresses in the graft that may activate local
clotting pathways.
Therapy will be typically applied between hemodialysis visits, e.g. 48 to 72
hours each
application following hemodialysis. The tensioned tissue therapy may also he
provided along
the implantation site of a new hemodialysis graft or AV fistula formation
surgery or AV fistula
revision procedure. For AV fistulas, treatment with tensioned tissue devices
may be 1 to 2
weeks, 2 to 4 week, 4 to 8 weeks, 8 to 12 weeks, or the entire maturation time
from the surgery
to the first use of the fistula. For AV grafts, treatment with tensioned
tissue devices may be in
the range of 1 to 2 weeks, 2 to 3 weeks, or 2 to 4 weeks, for example.
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In still other embodiments, the tensioned tissue treatment devices may be used
to treat the
post-implantation site of a pacemaker housing, implantable cardioverter
defibrillator (ICD), or
implantable pulse generator of a neuromodulation system, and the subcutaneous
implantation
site of a neuromodulation electrode. The neuromodulation systems may be used
to perform
spinal cord stimulation (SCS) to treat low back pain, such as the SPECTRA
WAVEWRITER
and PRECISION SCS systems by Boston Scientific (Marlborough, MA), the INTELLIS
and
RESTORE neurostimulator system by Medtronic (Minneapolis, MN), the SENZA OMNIA
system by Nevro (Redwood City, CA) and the PROCLAIM and PRODIGY SCS systems by
Abbott (Austin, TX). Treatment may reduce or prevent implantation site pain,
paresthesia,
paralysis, spinal cord compression, swelling, inflammation, ulceration or
erosion, capsular
fibrosis, tissue ingrowth and/or implant migration. In some instances, firm
fibrotic capsules
form around the implant and begin to squeeze the implant or capsular
contracture, causing
tenderness and pain. This effect may be reduced with treating using a
tensioned tissue treatment
device.
In other examples, the tensioned tissue treatment devices may be used to
directly treat
diseases that involve subcutaneous tissue or structures. These may include
autoimmune
diseases, metabolic diseases, endocrine diseases, genetic diseases,
inflammatory diseases,
oncologic diseases, infectious diseases, and the like. For example, certain
disease may result in
the development of subcutaneous calcifications in the dermis or subcutaneous
tissues, often as a
result of inflammation from a variety of etiologies. It is believed that
symptomatic treatment of
calcifications visualized on medical imaging may reduce pain or progression of
calcifications
with the application of tensioned tissue treatment devices as described
herein. Such diseases
may include autoimmune diseases such as dermatomyositis and scleroderma,
metabolic disease
such as hyperparathyroidism, and inflammatory conditions such as sarcoidosis,
as well as
calciphylaxis of the subcutaneous vasculature associated with end-stage renal
disease, multiple
myeloma, rheumatoid arthritis, and liver cirrhosis. Calcifications with
associated tissue erosion
may also be treated. Symptomatic treatment with tensioned tissue treatment
devices may be
applied for 1 to 2 weeks, 2 to 4 week, 4 to 8 weeks, 8 to 12 weeks, for
example, to dermal or
subcutaneous calcifications.
In other examples, the tensioned tissue treatment devices may be used to treat
lived()
reticularis or livedo racemosa, or other vascular diseases of the medium size
blood vessels found
in the subcutaneous tissue. These disease phenomena are characterized by
blotchy, net-like
colored patterns of the skin, which are thought to originate from alterations
in blood flow,
vasospasm, venodilation, thrombosis or increased blood viscosity. The
tensioned tissue treatment
devices may be used alone or in conjunction with systemic therapy directed to
the underlying
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cause of the skin condition. Causes may include, for example, vasculitis,
polyarteritis nodosa,
temporal arteritis, Takayasu arteritis, lupus erythematosus, Still's disease,
rheumatic fever,
endocarditis, hepatitis, anti-phospholipid syndrome, cryoglobulinemia, deep
vein thrombosis,
thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, and the like.
Medication-
induced vascular changes may also be treated. Treatment periods with the
tensioned tissue
treatment devices may be in the range of 1 to 2 weeks, 2 to 4 week, 4 to 8
weeks, 8 to 12 weeks,
as needed. Treatment may also temporarily improve the cosmesis of congenital
vascular
malformations, which may persist for hours, days or weeks following temporary
treatment.
In some other embodiments, tensioned tissue treatment devices may be used in
conjunction
with body sculpting or contouring procedures. Treatment combined with these
procedures may
accelerate healing post-procedure or improve the contouring effect by reducing
subcutaneous
tissue inflammation during the healing process. Such procedures may include
invasive energy-
based, cooling-based or mechanical-based lipolysis or septae disruption, as
well as non-invasive
vacuum and massage therapies that may be combined with invasive body sculpting
procedures or
used alone. Use of invasive lipolysis procedures has been associated with
development of
subcutaneous fibrosis, which may be the result of inadequate removal of
disrupted subcutaneous
cells or connective tissues. In some examples, tensioned tissue treatment
systems may be
applied after an invasive body sculpting procedure, or between an invasive and
a non-invasive
body sculpting procedure, or between treatments of a multiple treatment
regimen. Treatment
after an invasive body sculpting procedure may be performed for 1 week to 3
months, or 2 weeks
to 6 weeks, or 4 weeks to 12 weeks, for example, while treatments between
multi-treatment
regimens will vary depending on the treatment schedule, which could be as
above, or in the
range of 3 to 5 days, 5 to 7 days, 7 to 10 days, 3 to 7 days, or 7 to 14 days
after each procedure of
the regimen or treatment schedule.
In some examples, the dressing, and optionally one or more structures of the
dressing
support structure, may comprise one or more openings that may facilitate the
use of the strained
dressing with an indwelling catheter, cannula or sensor that is inserted into
the tissue. In other
examples, the device used with the dressing may be transiently inserted
through the dressing, e.g.
a needle for a blood draw, or needle biopsy tool. FIG. 30A depict one
embodiment of the
strained dressing 3000 with an opening 3002 that has been applied to a target
site 3004 and
released from its applicator (not shown) to transfer stress from the dressing
3000 to de-tension
the treatment site 3004. An indwelling device, such as an infusion set for an
insulin pump system
or an indwelling sensor system, may then be placed through the access aperture
3002 and into
the skin or subcutaneous tissue at the treatment site. In this particular
example depicted in FIGS.
30B to 30D, an infusion set 3006 for use with a medication pump comprises a
housing 3008,
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connector tubing 3010, a support layer 3012 for an adhesive layer, and a
needle 3014. In this
particular embodiment, the needle has an acute angle orientation relative to
the plane of the
support layer 3012, but in other examples, the needle may have an orthogonal
orientation, or
may be in the same plane or otherwise parallel to the plane of the housing or
support layer. The
needle length may or may not extend beyond the peripheral boundaries of the
housing or support
layer. The needle sheath (not shown) and/or adhesive protection layer (not
shown) of the
infusion set 3006 is removed. The needle 3014 is then aligned with the opening
3002, as shown
in FIG. 30B, until the needle 3014 is fully inserted into the target site 3004
and the adhesive of
the support layer 3012 is adhered to the dressing 3000 and/or target site
3004. In some further
variations, a protective dressing may be partially or completed applied over
the strained dressing
and infusion set. In some variations, the direction of strain in the dressing
may be parallel or
preferably transverse to the direction of the needle insertion into the target
site, or parallel or
preferably transverse to the length of the dressing.
In addition to the manual insertion of the needle of an infusion set or
indwelling device
through an aperture of the dressing, in some variations, the infusion set or
indwelling device may
comprise a delivery tool or system to facilitate the insertion or placement of
the infusion set or
indwelling device. The delivery tool may be easier or otherwise require less
dexterity to grip
than the smaller infusion set, or may hide the delivery needle from the user
and/or may
automatically insert and/or withdraw the delivery needle during the insertion
procedure, which
may improve compliance or other aspects of the user experience. In FIGS. 31A
to 31C, for
example, the dressing 3000 with aperture 3002 may be placed at the target site
3004, but where
the infusion set 3020 comprises an exposed orthogonal needle 3022 is
releasably coupled to a
larger delivery device or device 3024. The delivery device 3024 and/or needle
3022 is aligned
with the dressing 3000 and/or aperture 3002, as shown in FIG. 31A, and then
place against the
dressing 3000, as shown in FIG. 31B. The actuator 3026 on the device 3024 is
then activated to
separate the pod 3024 from the infusion set 3020. In this particular
embodiment, the infusion set
3020 does not have an adhesive support layer that extends beyond the
peripheral boundary of the
infusion set housing 3021. Instead, the adhesive may be provided directly on
the inferior surface
of the housing 3021, with or without any support layer therebetween. FIGS. 31D
and 31E are
cross-sectional views depicting the actuation mechanism of the delivery device
3024 and the
detachment of the delivery device 3024 from the infusion housing 3021. The
infusion housing
3021 may be mechanically attached to the delivery device 3024 by friction
and/or by one or
more mechanical interlocks 3030. To release the infusion device 3020, the
actuator 3026 is
depressed and plunger tip 3032 engages catch lever 3034 to release infusion
housing 3021. The
actuator 3026 and the plunger tip 3032 are maintained in the non-engaged
position by a spring
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3036. In another variation, the infusion housing may be releasably attached
using an adhesive
such as a gel that temporarily adheres the plunger tip to the superior surface
of the infusion
housing.
Although the exemplary dressings above comprise a single circular aperture
that is
centrally located, in other examples, the apertures may have other shapes,
sizes and/or eccentric
locations, and may comprise other markings or indicia. The markings or indicia
may be used to
differentiate between different openings, and/or to facilitate alignment of
the dressing with the
target location and/or inserted device. Some variations may also include more
than one aperture,
e.g. two, three, four, five or more apertures. In still other examples, a
dressing may be provided
without an aperture, and the needle of the infusion set, syringe or insertion
device is used to
pierce the dressing and then inserted through the skin or tissue.
FIG. 32A depicts the exemplary embodiment of the dressing 3000 in FIGS. 30A to
31C.
The dressing 3000 comprises an oblong shape with rounded comers and a
centrally located
circular opening 3002. The opening 3002 may have a diameter of about 0.10" to
0.30", or 0.05"
to 0.20". The dressing 3000 has a longitudinal length that is greater than its
transverse width, but
in other examples, the dressing may be radially symmetrical. The length and/or
width of the
dressing may be in the range of 4 cm to 16 cm, or 2.5 cm to 5 cm, or have a
surface area of 9 cm2
to 19 cm2, or 46 cm2 to 70 cm2.
FIG. 32B depicts another exemplary embodiment of a dressing 3200, comprising
multiple
openings 3202, 3204, 3206. In this particular embodiment, the openings 3202,
3204, 3206 are
linearly aligned with each other, and optionally linearly aligned along the
central longitudinal
axis of the dressing 3200, as shown in FIG. 32B. Optional indicia 3208, 3210,
3212 may be
provided to facilitate changing of the insertion location during a single use
of the dressing 3200.
FIG. 33 depicts dressing 3200 placed against a skin location.
FIG. 32C depicts another exemplary embodiment of a dressing 3220, comprising
multiple
openings 3222, 3224, 3226, 3228. In this example, one opening 3222 is
centrally located, but
the other three openings 3224, 3226, 3228 are eccentrically located and no
three openings are
linearly arranged. In other examples, all of the openings may be eccentrically
located. Indicia
3230, 3232, 3234 and 3236 may optionally be provided for each opening 3222,
3224, 3226,
3228, along with other optional indicia such as the spiral lines 3238, which
may he used to
indicate relative locations.
Other exemplary dressings may include dressings with one or more opening
shapes that are
non-circular. FIG. 32D, for example, depicts a dressing 3240 with an oval
opening 3242, and
FIG. 32E depicts a dressing 3250 with a diamond shaped or parallelogram shaped
opening 3252.
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FIG. 57A to 57D depicts another embodiment of a tensioned tissue treatment
system 5700,
comprising a dressing 5702 and one or more removably attachable injection
templates 5704a-c.
The templates 5704a-c (a subset of three of five exemplary templates are
depicted) are
temporarily applied to the dressing in order to indicate to the user where to
inject, while being
removable so that bulkiness or discomfort of the tensioned tissue treatment
system is reduced
between injections. As with many of the exemplary embodiments depicted herein,
the dressing
5702 is depicted schematically without an applicator or tension applicator
that are described
elsewhere herein for simplicity. Each of the templates 5704a-c have the same
size and shape but
includes a plurality of injection openings 5706a-c, 5708a-c, 5710a-c, 5712a-c,
each at a different
location on the template 5704a-c relative to the other templates 5704a-c.
Thus, each template
5704 is used on a different day to assist the user to rotate injection sites
with each injection every
day. Indicia 5714a-c may also be provided on the template 5704a-c to help the
user or caretaker
with identifying which template 5704a-c to use for each time period. The
indicia 5714a-c
preferably comprises a set of ordinal indicia or words indicating a numerical
or alphabetic series,
but in other variations may comprise other sets of indicia that may be non-
ordinal. Although the
injection openings 5706a-c, 5708a-c, 5710a-c, 5712a-c of each template 5704a-c
are grouped or
clustered together in different areas of each template 5704a-c, in other
variations, the injection
openings on each template may be located at different locations relative to
the other templates,
but not clustered such that the perimeter of the shape defined by the openings
on each template
may overlap or intersect the perimeter of the shape provided on other
templates of the same set.
This exemplary template also comprises four injection openings 5706a-c, 5708a-
c, 5710a-c,
5712a-c, but in other variations, two, three, five or six openings may be
provided for each set or
group of injection openings for each template. In another embodiment, the
injection template is
a transparent thin film polymer (e.g. polyethylene terephthalate,
polycarbonate, or similar) and
may be printed with an outline of the dressing shape to visually align over.
Because of the
materials, the thin polymer film may cling and temporarily adhere to the
silicone dressing
without the need for an adhesive or other attachment mechanism. Once the
template 5704a-c is
aligned and attached to the dressing 5702. The template openings 5714a-c,
5706a-c, 5708a-c,
5710a-c will be generally coaxially aligned with one of the corresponding
groups of dressing
openings 5724a-e of the dressing 5702, to facilitate or permit injections
through the template
openings 5714a-c, 5706a-c, 5708a-c, 5710a-c and the groups of dressing
openings 5724a-e.
Some variations in alignment of the template openings 5714a-c, 5706a-c, 5708a-
c, 5710a-c and
the dressing openings 5724a-e may occur due to variations in the tensioned
size of the dressing
5702. In other variations, however, dressing openings of the embodiments
herein are not
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provided and a needle may be passed through the template opening and then
pierces through the
dressing for the injection.
To facilitate the reproducible alignment of the injection templates 5704a-c to
the dressing
5702, one or more complementary alignment structures 5720, 5722, 5716a-c,
5718a-c may be
provided on the dressing 5702 and templates 5704a-c. In this particular
example, flat but raised
alignment structures 5720, 5722 are bonded, heat melded or welded to the upper
surface of each
end of the dressing 5702. In other examples, the alignment structures may be
apertures in the
dressing which may be aligned with raised alignment structures on lower
surface of the
templates. Complementary alignment structures or openings 5716a-c and 5718a-c
are arranged
on the template 5704a, which can form interfit or interlock with the alignment
structures 5720,
5722. In some variations the geometric shapes of the alignment structure 5720,
5722 are
different, e.g. square and triangle, so as to limit the orientations of the
injection template 5704a-c
when attached to the dressing 5702. Other shapes that may be used include
rectangles, slots,
circles, ovals or other polygonal shapes. The shapes may be configured with a
tolerance that
allows alignment when the dressing is stretched or contracted in along the
orientation direction
between the alignment structures. For example, the raised alignment structures
5720, 5722 may
be slightly undersized when compared to the complimentary alignment structures
or openings
5716a-c and 5718a-c on the template(s) 5704a-c, to accommodate variations in
the length of the
dressing when it is adhered to the skin, from movement and/or positioning. In
some further
embodiments, the complementary alignment structures may be further configured
to provide a
removable snapfit between the dressing and template, to resist inadvertent
misalignment or
unintended separation. The template may be manufactured a single layer or
multi-layer structure,
comprising woven or a non-woven structure, and include materials such as
polyamide, polyester,
polyethylene, paperboard, and the like. Any indicia on the template may be ink
printed, silk-
screened, embossed, die-cut, stamped or laser etched on the surface of the
template. In still other
variations, the template(s) may comprise an elastic material that accommodate
variations in the
stretched length and/or width of the dressing when it is adhered to the skin.
With an elastic
template, the elastic material may comprise a force per millimeter width that
is lower than the
force per millimeter width of the dressing itself, e.g. 50% or less, 40% or
less, 30% or less 20%
or less, or 10% or less, so that the tension in underlying tissue and the
dressing is no substantially
altered by the temporary attachment of the template.
The size of the injection openings 5706a-c, 5708a-c, 5710a-c, 5712a-c may
vary, with a
diameter or maximum transverse dimension in the range of about 3 mm to 20 mm,
5 mm to 15
mm, or 8 mm to 12 mm. The size of the injection openings may be sufficiently
large so that the
user can adequate clean the injection site with an alcohol swab prior to
injection, and/or for
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adequate visibility by patients with poor vision, e.g. diabetic retinopathy.
The perimeter of the
injection openings may be optionally raised to provide tactile feedback to
facilitate positioning of
a needle, which may assist users with poor vision or color blindness.
While the tensioned tissue treatment system 5700 in FIGS. 57A to 57D comprises
a
plurality of different templates 5704a-c, each for use with a different time
period, e.g. one day, in
other examples, a treatment system may include a template configured with
injection openings
for multiple time periods. In FIG. 58, for example, the tensioned tissue
treatment system 5800
comprises a dressing 5802 that is similar to dressing 5702 from FIGS. 57A, but
wherein the
template 5804 is configured with multiple groups of injection openings 5808a-
g, each group
optionally labeled by its own indicia 5806a-g and/or separated by separation
indicia 5818.
During use, the template 5804 is attached to the dressing 5802 via the
alignment structures 5810,
5812, 5816, 5818. Once attached, the groups of injection openings 5808a-g of
the template 5804
will be generally or coaxially aligned with the corresponding groups of
injection openings
5820a-g of the dressing 5802. This facilitates or permits injections through
the injection
openings 5820a-g of the template 5804 and through the groups of injection
openings 5820a-g of
the dressing 5802. As noted elsewhere, some variations in alignment of groups
of injection
openings 5820a-g and the groups of injection openings 5820a-g of the dressing
5802 may occur
due to variations in the tensioned size of the dressing 5802.The user then
identifies which set of
openings 5808a-g to be used, and then, based on the time of day or meal,
identifies which of the
injection openings for that set of openings 5808a-g to be used for the
injection used. The
example system 5800, illustrated in FIG. 58, includes three injection openings
per group 5808a-
g, but noted elsewhere herein, while in other variations, two, four, five or
six openings may be
provided per group. Each group 5808a-g has a linear arrangement of openings
that is transverse
to the long axis of the template 5804, but in other variations may have a
cluster arrangement
equally spaced around a central point to ensure proper injection rotation,
without overlap
between groups 5080a-g. The other features of the system 5800 may otherwise be
similar to the
range of features as described for system 5700.
FIGS. 59A to 59E depict another variation of a tensioned tissue treatment
system 5900.
The system 5900 comprises a dressing 5902 with a multi-time period template
5904 similar to
the system 5800 in FIG. 58, hut wherein each subgroup of template openings
5908a-g is covered
by a single removable adhesive cover 5920a-g. The first openings of each group
5908a-g is
aligned with first openings of the other groups with respect to the
longitudinal axis of the
template 5904, as is each of the subsequent openings of each subgroup with the
corresponding
openings of the other subgroups. This results in the subgroup of openings
5908a-g forming a
rectangular grid of openings. In other variations, however, the arrangement
and alignments of
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the subgroups may be different, as will be described for other exemplary
embodiments below.
Each cover 5920a-g has a shape and size sufficient to cover all the
corresponding openings in a
group of openings 5908a-g, and further configured to extend beyond the outer
edge 5926 of the
template 5904, to facilitate grasping and removal of each cover 5920a-g by a
user. Each cover
5908a-g optionally further comprises different indicia 5924a-g to assist the
user to identify which
group of openings 5908a-g to use each day. The indicia 5924a-g may comprise
ordinal numbers,
letters or words, or may comprise symbols. Although the covers 5924a-g
depicted in FIGS.
59A-59E are configured to extend beyond the same side of the edge 5926 of the
dressing and are
arranged consecutively from one end of the template 5904 to the other end, in
other variations,
the covers may be arranged to extend from either of the two sides of the
template, e.g. in an
alternating fashion, and/or in a non-consecutive arrangement. The latter may
be beneficial to
provide greater spacing between the groups of openings based on the order in
which the covers
and groups of openings are removed per the indicia on the covers. With the
indicia 5924a-g
located on the covers 5920a-g, other indicia, like the ordinal indicia 5806a-g
or the separation
indicia 5814 found in the system 5800 in FIG. 58, may or may not be provided.
The covers may
comprise a flexible polymeric or paper material, and the adhesive adhering the
cover 5920a-g to
the template 5904 may be a pressure sensitive adhesive, e.g., polyacrylate-
based,
polyisobutylene-based, silicone-based pressure sensitive adhesives, synthetic
rubber, acrylic, and
polyisobutylene (PIB), hydrocolloid, and the like. Preferably, the t-peel
force of the cover
adhesive is significantly lower than the t-peel force provided on the dressing
5902, so that the
dressing 5902 or the template 5904 is not pulled off during use if the
template 5904 is attached to
the dressing 5902 before the cover 5920a-g is removed. The alignment
structures 5910, 5912,
5914, 5916 of the dressing 5902 and template 5904 may otherwise be similar to
systems 5700,
5800 described previously, or the other variants described elsewhere herein.
Once aligned, the
subgroups of template openings 5908a-g are aligned with corresponding
subgroups of dressing
openings 5928a-g of the dressing 5902.
In use, the system 5900 involves the removal of any dressing 5902 that was
previously
applied. Depending on the type of adhesive provided on the dressing, water or
an alcohol or
emollient adhesive remover may be used to avoid or reduce the risk of medical
adhesive related
skin injury. The new injection area is identified and cleaned, and then the
new dressing 5902 of
the system 5900 is applied to the new injection area. The template 5904 is
then grasped, and the
first or the next consecutive cover 5908a-g is grasped and peeled away from
the template 5904
and removably attached to the dressing via the alignment structures 5910,
5912, 5914, 5916. If
the group of openings 5908a-g to be used already been removed earlier in the
day or time period,
the user may use an alcohol swab to wipe the exposed group of openings 5908a-g
prior to
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attachment to the dressing 5902. The user then prepares the injection and
selects the opening in
the group of openings 5908a-g based on the time of day or meal time, and
injects the therapeutic
agents through the selected opening. After the injection is completed, the
template 5904. This
procedure is repeated several times per day until the dressing is replaced, as
shown in FIGS. 59B
to 59E, illustrating Days 1-3 of a newly applied system 5900.
FIGS. 60A to 60D depicts another variation of a tensioned tissue treatment
system 6000,
which is similar to system 5700 and its variants, except that instead of one
attachment shape
located at each end of the dressing and template(s), with the shapes being
different, the
attachment shapes are each the same size and shape, but there are different
numbers of them at
each end. In the example in FIGS. 60A to 60D, one end of the dressing 6002
comprises a single
circular shape 6012a, while the other end comprises two circular shapes 6014a,
6016a. Likewise
the complementary attachment structures on the templates 6004a-c comprise a
single
complementary circular opening 6012a-c at one end of the templates 6004a-c and
two
complementary circular openings 6014a-c, 6016a-c at the other end. The
difference in the
number of shapes at each end specifies the relative orientation of dressing
6002 and template
6004a-c. Once the template 6004a-c is aligned and attached to the dressing
6002. The groups of
template openings 6020a-c will be generally coaxially aligned with one of the
con-esponding
groups of dressing openings 6024a-e of the dressing 6002. This facilitates or
permits injections
through the groups of template openings 6020a-c and the groups of dressing
openings 6024a-e.In
still further variations, other shapes besides circles may be provided, and
even in embodiments
where different shapes are provided, the number of shapes may still be
different and/or different
sizes of the same shape may be included. The number of shapes on each end may
be in the range
of one to five, one to four, one to three or one to two. The shapes may be
arranged linearly or
may be clustered around a common center point. In still other variations,
instead of a different
size openings on the templates that form a complementary interfit with
protruding shapes on the
dressing, hook-and-loop applicators, adhesives, and/or magnetic attachment
structures may be
used to removably couple the dressing and templates.
Due to variations in the equilibrium state between a tensioned tissue
treatment device and
the underlying tissue, the resting size, and therefore the distance between
the attachment
structures on the dressing component of the system may vary. To accommodate
these variations
during template attachment and the injection of the therapeutic agent, a
linear set of attachment
structures may be provided, or a modified opening may be provided wherein the
opening is
configured to form an interfit with the attachment structure of the dressing
across a transverse
axis of the template, but permits longitudinally variable positions along the
longitudinal axis.
FIG. 61A depicts an example of an alternate template 6104 that may be used
with the system
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5700 in FIGS. 57A to 57D. This template 6100 comprising a single attachment
opening 6102 at
one end, and a plurality of openings 6104a-c at the other end. During use one
single attachment
opening 6102 is first attached to the dressing, then the opening 6104a-c of
best fit to attach to the
corresponding attachment structure on the dressing is selected to minimize any
fold or ruffles, or
excessive stretching in the template 6104 or dressing. FIGS. 61B depicts an
embodiment of an
alternate template 6120 that may be used with system 5700 in wherein instead
of triangular
attachment opening, a trapezoidal attachment opening 6122 which is configured
to form an
interlock with a triangular attachment structure of a dressing anywhere along
the length of the
trapezoidal opening 6122. The trapezoidal opening 6122 is oriented along the
longitudinal
length of the template, so as accommodate variable dressing lengths and
therefore variable
dressing attachment structure positions. FIG. 61C depicts an exemplary
alternate template 6140
that may be used with the system 6000 in FIGS. 60A to 60D, comprising two oval
openings
6142a,6142b that are oriented along the longitudinal length of the template,
to accommodate
variable positions of the two circular openings of the dressing 6002 of system
6000. FIG. 61D
depicts an exemplary alternate template 6160 that may be used with systems
5800 or 5900, also
with a trapezoidal opening 6162 to accommodate the variable position of a
triangular attachment
structure of a corresponding dressing. In each of the templates 6100, 6120,
6140, 6160, the
attachment opening may be larger than the corresponding attachment
structure(s) 6104a-c, 6122,
6142a-b, 6162, to accommodate variable dressing lengths and therefore variable
dressing
attachment structure positions. In each of the templates 6100, 6120, 6140,
6160, the attachment
opening on the right of the template was configured to accommodate the
variable attachment
position, but in other variations, the attachment opening on the left side of
the template may be
configured as such.
FIG. 62A depicts another embodiment of a tensioned tissue treatment system
6200,
comprising a dressing 6202 without any template. Instead, the plurality of
openings 6204 are
surrounded by a plurality of adhesive removable rings 6206. The rings 6206 are
preferably made
of a soft foam. As each opening 6204 is used, the foam ring 6206 may be
removed or peeled off
from the dressing 6202 to indicate its usage. In this particular embodiment,
no indicia or groups
are necessarily provided, and the user may be instructed to use any previously
unused opening
6202 s indicated by the remaining or existing foam rings 6204, and may or may
not be instructed
to use the openings 6202 in any particular order or manner, e.g. across the
each row or column of
the grid of openings 6202, and to the another row or column, whether adjacent
or not
FIGS. 62B and 62C depict other exemplary embodiments of tensioned tissue
treatment
dressings 6220, 6240 which are not used with templates. In these particular
embodiments, each
dressing 6220, 6240 comprises individual adhesive covers 6222 for each
dressing opening (not
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shown). Each cover includes a main body 6222a that is adhered to the dressing
surrounding each
dressing opening. A smaller flap 6222b is also included. The flap 6222b may be
non-adhesive to
the dressing surface, to facilitate grasping of the cover 6222 for peeling off
the main body 6222a.
Dressing 6240 in FIG. 62C is similar to dressing 6220 in FIG. 62B, except that
each of the
covers 6242 also includes an indicia 6242c, in addition to the adhesive main
body 6242a and
non-adhesive flap 6242b. The indicia 6242c on each cover 6242 may be arranged
in groups
6244a-g to facilitate the order of use by day or other time period. In this
particular example, the
indicia 6242c of each group 6244a-g may be identical, but in other variations,
each indicia 6242c
may be different. As noted for other embodiments, the indicia 6242c may be
ordinal numbers or
letters, or may comprise other symbols indicating a time of day or meal, e.g.
sunrise, moon, food
symbols. Referring to FIGS. 62D to 62G, the use of dressing 6220 depicts its
initial use with the
removal of a first cover 6222 via the flap 6222b, to peel away the adhesive
body 6222a, to
expose the underlying dressing opening 6224a The covers 6222 may be removed in
order using
the next closest adjacent cover 6222, as depicted in FIG. 62G, but in other
variations, any unused
cover 6222 on the dressing 6220 may be selected for use.
FIG. 63 depicts another embodiment of a tensioned [issue treatment system 6300
comprising a dressing 6302 with a plurality of removable tabs or covers 6304a-
g. In this
particular embodiment, the covers 6304a-g are detachable from the dressing
6302 to expose the
injection opening (not shown). Each cover 6304a-g, however, has one or more
raised bumps or
protrusions, so that limited sight users, e.g. those with diabetic retinopathy
or other visual
impairment, can identify unused openings of the dressing 6302, remove the
cover 6304a-g and
perform the injection. The bumps on each cover 6304a-g may comprise a
sequentially
incremented number of bumps to indicate the time period of use, as shown in
FIG. 63, but in
other variations, the bumps may be braille alphabet or numbers to indicated
sequential letters or
numbers to indicate or to track the order of use.
FIGS. 64A and 64B depict another variation of a tensioned tissue treatment
system 6400,
comprising a dressing 6402 with a longitudinal axis 6404 and a transverse axis
6406, and a
plurality of openings 6408, which in turn comprise subgroups of openings 6408a-
g, where each
subgroup of opening are covered an adhesive removable cover strip 6410a-g. in
system 6400,
however, the plurality of openings 6408 have an optionally transversely
staggered arrangement,
wherein the first openings of each subgroup 6208 a-g is aligned longitudinally
with first
openings of the other subgroups 6408 a-g, but each sequential opening of a
subgroup 6408 b-g is
transversely offset from the earlier opening within each subgroup and
optionally aligned with the
earlier opening of the next adjacent subgroup 6408 b-g. This results in
subgroups 6408 a-g that
are linearly arranged but oriented at an angle to both the longitudinal and
transverse axes of the
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dressing 6400, as depicted in FIG. 64A, as are the adhesive cover strips 6410a-
g. In the
particular example in FIG. 64A, the plurality of openings 6408 comprise seven
subgroups 6408a-
g, each with four openings, and a cover strip 6410a-g for each of the
subgroups. Each of the
adhesive cover strips further comprise optional removable foam rings 6412
around each of the
openings. As each injection hole is used, the foam ring 6412 associated with
the injection
opening is removed. This indicates to the user that the opening has already
been used and not to
use it again for the duration of the dressing application. In other
variations, the foam rings
around each dressing are not removable from its strip 6410a-g, but the strip
6410a-g is removed,
as illustrated in FIG. 64B for strip 6410a, to indicate usage for each day or
time period.
It is hypothesized that the staggered arrangement of openings and subgroups of
openings in
system 6200 may provide a greater separation distance between the injections
performed each
day while still grouping the openings in a manner to provide for multi-day or
weekly use for
each dressing or system. In the particular example in FIGS. 64A and 64B, the
longitudinal
spacing between adjacent openings of adjacent subgroups may be about 0.49", or
in the range of
0.4" to 0.6", 0.3" to 0.5", and the transverse spacing between adjacent
openings of adjacent
subgroups may be about 0.21", or in the range of 0.15" to 0.3", or 0.12" to
0.35". The resulting
distance between adjacent openings of the same subgroup would be about 0.533",
or in the range
of 0.5" to 0.6", 0.45" to 0.7".
In other embodiments, instead of temporarily attaching and then removing an
injection
template, a set of injection guides may be provided permanently on the
dressing. While the
injection guides may be pre-attached to the dressing during the manufacturing
processes, in other
variations, the injection guides may be adhered to the dressing after the
dressing has been
attached and after the dressing tension has been released to offload the
tension in the tissue.
FIGS. 65A to 65G, depicts an injection guide system 6500 comprising a
plurality of separate
adhesive injection guides 6504a-g, which are removably covered by a plurality
of guide covers
6506a-g. The plurality of adhesive injection guides 6504a-g are arranged or
configured to align
with a plurality of pre-formed dressing openings of a dressing, with subgroups
6512a-g of the
dressing openings in alignment with the openings 6510a-g of the injection
guides 6504a-g. By
providing a plurality of separate injection guides 6504a-g, the dressing 6502
is able to stretch
and bend between the guides 6504a-g in comparison a single unibody template.
Being less rigid,
this allows the guides 6504a-g to remain on the dressing 6502 during the
entire use of the
dressing 6502, rather than temporary attachment used during injections. Once
attached to the
dressing 6502, the openings 6510a-g of the injection guides 6504 are aligned
with the subgroups
6512a-g of dressing openings 6512 of the dressing 6502 to permit injections
through guide
openings 6510a-g and the corresponding groups of dressing openings 6512a-g. To
protect
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unused subgroups 6512a-g of dressing openings the unused injection guides
6504a-g are covered
by removable guide covers 6506a-g. Each guide cover 6506a-g comprises a
flexible strip of
material that covers and is removably adhered to the injection guide 6504a-g,
with a portion of
the strip material lacking adhesive and extending beyond the perimeter or edge
of the injection
guide 6504a-g to facilitate its grasping and removal. Optional cover indicia
6508a-g may be
provided, to indicate the order of use. The surface of the injection guide
6504a-g may be coated
to facilitate removal of the guide covers 6506a-g.
As noted previously, the injection guides and guide covers may be pre-attached
to the
dressing during the manufacturing process, but in the embodiment depicted in
FIGS. 65A to
65G, the guides 6504a-g and guide covers 6512a-g may be provided separately
from the dressing
6502 and are adhered or attached to the dressing 6502 at the point-of-use or
post-manufacturing.
To facilitate their attachment to the dressing, the guides 6504a-g and covers
6506a-g may be pre-
arranged on a carrier sheet 6520 with a low-tack adhesive, with the guides
6504a-g spaced apart,
oriented and aligned in a manner to match the corresponding subgroups of
dressing openings
6512a-g with the plurality of guides 6504a-g. The carrier sheet 6520 may
comprise a flexible or
semi-rigid, but non-elastic polymeric sheet which may be transparent to
facilitate visual
alignment of the carrier sheet 6520 and the dressing 6502. To further
facilitate alignment,
graphical indicia 6522 may be provided on the carrier sheet which corresponds
to the edges of
the dressing and/or aperture locations on the dressings, or other indicia on
the dressing that are
specifically complementary to the carrier sheet or the plurality of guides
6504a-g. For more
precise alignment, the graphical indicia 6522 may include complementary
checkerboard patterns
or other optical interference patterns corresponding to complementary
graphical indicia on the
dressing. In alternate embodiments, the carrier sheet may comprise a
transparent window and an
opaque outer frame, wherein the boundary of the window and frame forms a shape
corresponding to the dressing. In addition to the carrier structure or sheet
6520, a release liner
6524 may be provided to releasably protect the adhesive on the underside of
the plurality of
injection guides 6504a-g until the user is ready to attach the guides 6504a-g
to dressing 6502.
Together, these structures may comprise a guide applicator 6530.
In use, the selected tissue site for injections is cleaned in preparation for
the application of
the tensioned dressing 6502. The dressing 6502 is applied as described
elsewhere herein_ Next,
the guide applicator 6530 is prepared by the removal of the release liner
6524, to expose the
plurality of adhesive injection guides 6504a-g that are adhered in a
predetermined arrangement
or configuration on the adhesive underside of the carrier sheet 6520, via the
corresponding guide
covers 6506a-g. The user then views the dressing 6502 through the carrier
sheet 6520, using the
indicia 6522 on the carrier sheet 6520 to align the guides 6504a-g to the
openings on the dressing
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6502. Once the desired visual alignment is achieved, the user applies pressure
to guides 6504a-g
through the carrier sheet 6520 to maximize adhesion of the guides 6504a-g to
the dressing 6502.
The carrier sheet 6520 is then peeled away from the guide covers 6506a-g to
expose and leave
the guides 6504a-g and covers 6506a-g on the dressing 6502. The first cover
6506a is grasped
and pulled away, to expose the openings of the first injection guide 6504a.
The opening and
skin/tissue surface exposed in the opening are then sterilized with an alcohol
pad or other
sterilization procedure, and then the injectable therapeutic agent is prepared
and injected through
the sterilized opening of the guide. The same sterilization of remaining
openings of the injection
guide 6504a is performed for subsequent injections, and the next cover 6506b-g
is removed
when access to the next injection guide 6504b-g is needed.
As may be noted from the procedure above, the application of the injection
guides 6504a-g
and covers 6506a-g to the dressing 6502 involves a multi-layered adhesive
combination of
structure where the adhered layers are preferentially separated at different
stages of the
procedure. To facilitate this, different adhesives with different peel force
removal values are
used. The strongest or highest peel force adhesive is provided on the adhesive
layer of the
dressing for adherence to the skin, and the injection guide to the dressing.
This reduces the risk
of inadvertent peeling or removal of the dressing from the skin, or the
injection guide from the
dressing, when the guide covers are being peeled off. The next highest
relative adhesive is the
adhesive used to adhere the guide covers to the injection guides. This reduces
the risk that the
covers may be inadvertently removed or peeled away when the carrier sheet is
removed during
the application procedure. The next highest adhesive is the one on the
underside of the carrier
sheet or applicator template, which is pulled away after the injection guides
are adhered to the
dressing. The lowest peel force is the one between the release liner and the
injection guides. As
noted earlier, since the adhesive on the injection guides needs to have the
highest relative
strength to avoid inadvertent removal when a guide cover is removed, to
achieve a lower peel
force of the release liner from the injection guides, the release liner may
comprise a
fluorosilicone or silicone liner, e.g. FRA-310 (Fox River Associates; Geneva,
Illinois), 3M 9744
or 3M 5051 (3M; St. Paul, MN), and the like, to permit ease of separation of
the liner from the
strong adhesive provided on the injection guides.
The injection guides may comprise an adhesive foam tape or strip material,
such as
Adhesive Applications BW1125-1 or 1008-1 (Adhesive Applications; Easthampton,
MA). The
carrier sheet may comprise a transparent polymeric rigid or semi-rigid sheet
material, which may
be covered by a low-tack adhesive carrier or protective film known in the art,
such as Pregis
1614C (Pregis; Deerfield, IL). The guide covers may comprise a flexible
polymeric material
coated with a removable acrylic adhesive, such as A5000 by Adhesive
Applications.
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FIG. 34 depicts another variation of a dressing 3400 comprising indicia 3404
to facilitate
identification and/or alignment with the dressing opening 3402. In this
particular embodiment,
the indicia 3404 are provided in four orthogonal directions from the opening
3402. These indicia
may be helpful for identifying the location of the opening 3402, especially in
circumstances
where the dressing 3400 comprises a clear material and wherein the underlying
skin may be
mottled or has extensive markings from scarring or skin damage, which may make
identification
of the opening 3402 more difficult. The indicia may be laser etched or printed
onto the dressing
surface. FIG. 35 depicts the placement of a strained dressing 3400 onto a skin
location and then
released from its applicator (not shown). Once adhered to the skin location,
the indicia 3404
may be used to facilitate the insertion of a syringe needle 3406 or other
access device, while the
strain transferred from the dressing 3400 may reduce the tissue response from
the needle
insertion to form scar tissue or to induce lipohypertrophy. Although the
indicia 3404 in FIGS. 34
and 35 are in contact or otherwise close proximity to the opening 3402, in
other examples, the
indicia may be providing along the periphery of the dressing, or span the
dressing area between
the opening and edges of the dressing. This may be useful for aligning larger
devices that may
obscure the opening of the dressing once positioned over the dressing.
Alternatively, the
material of dressing 3400 may be opaque and/or colored to provide contrast
with the dressing
and the dressing opening 3402. In still other examples, a dressing may be
provided without an
aperture, and the needle of the infusion set, syringe or insertion device is
used to pierce the
dressing and then inserted through the skin or tissue.
In other examples as depicted in FIG. 36, a visual guide tool 3600 may be
optionally
provided or used to facilitate alignment of the syringe needle 3406 with the
dressing opening
3402. The visual guide tool 3600 includes peripheral indentations 3602 or
openings that may
facilitate alignment of the visual guide tool 3600 with the peripheral edges
of the dressing 3400.
The dressing 3400 may also be provided with optional indicia or markings to
facilitate alignment
with the guide tool indentations 3602. By aligning the peripheral edge of the
guide tool 3600
with the peripheral edge of the dressing 3400, the opening 3402 of the
dressing 3400 may then
be secondarily aligned with the opening 3604 of the guide tool 3600. The
opening 3604 of the
guide tool 3600 preferably may be smaller than the opening 3402 of the
dressing 3400, but in
other examples may be larger or the same size. The visual guide tool 3600 may
also include
indicia 3606 around its opening 3604, and may or may not comprise an opaque
material, which
may make it easier to visualize the opening 3604. The undersurface of the
visual guide tool may
comprise an adhesive to facilitate maintaining the position of the tool 3600
during use. The tool
3600 may comprise an elongate body with the opening 3604 at the distal end,
with the proximal
end used to grasp and manipulate the tool 3600 during the procedure.
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In one exemplary procedure, the user will clean and prepare skin site with
isopropyl
alcohol wipes or other sterile preparations. The dressing is then strained
using an applicator, if
the dressing is not a pre-strained dressing, and then placed onto the desired
site. The applicator
is then removed to transfer the strain to the skin. If a visual guide is not
needed, the patient can
insert the needle into the orifice in the dressing and administer the
infusion. If a visual guide is
required, place guide on top of dressing and insert the needle through the
visual target and
administer the infusion. For where there is a preexisting dressing with
multiple openings,
subsequent injection can follow a rotational sequence and inject in site #1,
followed by #2,
followed by #3, etc. In some variations, depending on skin conditions, a
dressing may last up
to 10 days and injections using the dressing may take place at frequencies of
3 per day. The
dressing is removed and replaced with a new dressing at the end of the wear
period (average 7-
10 days).
FIGS. 37A and 38B depict another example of a visual guide tool 3700. In this
example,
the tool 3700 comprises an elongate body 3702 with an enlarged distal end 3704
and a large
distal opening 3706. The distal opening 3706 may be configured with boundary
edge 3708 that
permits visualization of the outer edge of the dressing 3000, excluding the
radially inward
projections 3710, 3712, 3714, and 3716. These radially inward projections
3710, 3712, 3714,
and 3716 may help to point to the location of the dressing opening 3002 when
the tool opening
3706 is positioned to surround the dressing 3000. Although four projections
3710, 3712, 3714,
and 3716 are depicted in FIGS. 37A and 37B, in other examples, a different
number of
projections may be provided and at other locations along the boundary edge
3708 of the opening
3706, and may be different shapes, sizes, and lengths than the four orthogonal
projections 3710,
3712, 3714, and 3716 in FIGS. 37A and 37B, e.g. the projections may comprise
arrowhead
shapes.
As depicted in FIGS. 38A and 38B, in some variations, the projections 3710,
3712, 3714,
and 3716 may be configured to facilitate positioning of a delivery device or
pod, such as the
delivery device 3024 from FIGS. 31A to 31B. In this example, the lengths of
the projections
3710, 3712, 3714, and 3716 are configured so that the ends 3718, 3720, 3722,
3724 of the
projections 3710, 3712, 3714, and 3716 are each on contact with or equally
spaced from the
perimeter edge 3028 of the delivery device 3024 when the pod 3024 is properly
aligned with the
projections 3710, 3712, 3714, and 3716 of the tool 3700. Thus, the
configuration of the radially
inward projections 3710, 3712, 3714, and 3716 may facilitate alignment and
positioning of the
pod 3024 during use.
In another variation, depicted in FIGS. 39A to 39E, the strainable or strained
dressing 3926
may be a pre-strained at the point of manufacture to an infusion set 3921 or
assembly, as
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depicted in FIGS. 39A to 39E. The system may optionally include a delivery
device 3900 with
a body 3904, a lower edge 3906 and an actuator 3908. Releasably attached to
the bottom of the
body 3904 is an infusion housing 3921 of the infusion set 3920, and includes a
needle 3922,
connector tubing 3924 and a tension dressing layer 3926 that extends beyond
the lower edge
3906 of the delivery device 3900 and housing 3921. The tension dressing layer
3926 further
comprises a skin adhesive on its lower surface, which is removably covered by
one or more
adhesive protective liners 3928. The liners 3928 may comprise a liner tab 3930
that extends
further from the liner 3928 to facilitate removal of the liner 3928 from the
adhesive on the
tension dressing layer 3926. The tension dressing layer 3926 is maintained in
a stressed
configuration by a rigid applicator or tension support structure 3932 that
includes one or more
pull tabs 3934 to facilitate the separation of the tension dressing layer 3926
from the tension
support structure 3932 during use. The pull tabs 3934 attach the dressing
layer 3926 and support
structure 3932 together, but comprises perforations or adhesives that
facilitate separation of the
dressing layer 3926 and support structure 3932 when the pull tabs 3934 are
pulled away from the
device. The tension support structure 3932 or applicator may be removed from
around the
infusion housing 3921 by passing the structure 3932 over the connector tubing
3924, or by
tearing the structure 3932 away from the housing 3921.
In one exemplary implantation procedure for the integrated infusion set 3920,
a skin
insertion site is selected and prepared with isopropyl alcohol wipes or other
sterile preparation.
The protective needle sheath (not shown) is first removed from the needle 3922
of the integrated
infusion set 3920 as it is engaged to the delivery system 3900. Next, the
adhesive protective
liners 3928 are removed to expose the adhesive on the inferior surface of the
prestrained tension
dressing layer 3926. In other examples, however, the needle cover may be
integrated with a
liner, such that removal of the needle sheath concurrently removes the
protective liners or vice
versa. The delivery system 3900 and infusion set 3920 is then positioned at
the desired insertion
site and the needle is advanced into the skin, either manually or via a needle
advancement
mechanism. Once inserted, the system 3900 may be used to push the infusion set
3920 against
the skin or otherwise held in place to facilitate bonding between the adhesive
and the skin tissue
surrounding the needle 3922. The actuator 3908 on the system 3900 is then
actuated to release
the infusion set housing 3920 so that the delivery system 3900 may be removed,
as depicted in
FIG. 40A. In other examples, the infusion set 3920 with integrated dressing
may be inserted
without the use of the delivery system 3900.
Next, the pull tabs 3934 are removed from the infusion set 3920, which allows
the strained
dressing layer 3926 to decouple from the tension support structure 3932,
thereby allowing
strained dressing layer 3926 to transfer its tensile stress to a compressive
force acting on the
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tissue surrounding the needle 3922, as shown in FIG. 40B. In some variations,
the tension
support structure 3932 may be left in place after the pull tabs are removed,
but in other examples,
the tension support structure 3932 may be removed, to decrease the bulk and/or
rigidity of the
indwelling infusion set 3920. In some variations, the tension support
structure 3932 may be
removed by passing the tension support structure 3932 over the connector
tubing 3924, as
depicted in FIG. 40C, if the connector tubing 3924 is not yet coupled to the
infusion pump,
leaving the infusion set 3920 with the dressing layer 3926 transferring
compression to the
underlying skin tissue, as shown in FIG. 40D. In other variations, as depicted
in FIG. 40E, the
tension support structure 3932 may comprise a slit or perforations 3940, which
may allow the
tension support structure 3932 to be pulled away or torn away, from the
infusion set housing
3921 or the connector tubing 3924, whether the connector tubing 3924 has been
attached or not.
The infusion set 3920 is ready for use, and may be removed and a new infusion
set may be
placed at the end of the use period, which may be in the range of 7 to 10
days, but may be
replaced earlier if occluded or damaged.
In some other examples, rather than visual indicia or markings, one or more
physical
alignment structures may be provided on the dressing to facilitate alignment.
In FIGS. 49A to
49E, a pre-strained elastic member or dressing 4900 with a pre-attached
removable alignment
structure 4902 is provided that is configured to align an infusion set with
access opening 4926 of
the dressing 4900. This alignment structure 4902 is configured for use with
the MINIMEDTm
QUICK-SERTERTm (Medtronic, Fridley, MN) infusion set applicator 4904, but one
of skill in
the art understands that the alignment structure may be tailored to the shape
and function of any
other infusion set applicator or delivery device. The pre-strained dressing
4900 is maintained in
a pre-strained configuration by semi-rigid or rigid strain support 4906
attached or adhered to the
top surface of the dressing 4900, and surrounding the alignment structure
4902. The strain
support may be configured to have some flexibility in at least one direction
in order to contour
the dressing to the tissue surface. In some variations, the direction of
flexibility may be
orthogonal to the direction of strain of the dressing. The shear bond strength
between the strain
support and the strained elastic member is greater than the force produced by
the straining of the
elastic member. The attachment of the support 4906 to the dressing 4900 may be
achieved with
an adhesive, or may be heat staked to the dressing 4900, depending on the
materials selected for
the dressing 4900. For example, if a polyurethane is used for the dressing
4900, the support
4906 may comprise PETG and can be heat staked to the dressing 4900. For
example, a heat stake
may be used to bond the strained elastic member to the strain support. The
heat stake may have a
width of about 1 mm, 2 mm or 5 mm, for example. The bond provides adequate
shear force
without creep in the direction of strain while also allowing the support
structure to be peeled
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away from the elastic member. The strain support may also comprise
perforations to facilitate the
splitting of the strain support and its separation and removal from the
elastic member, and
optionally tabs to facilitate grasping and tearing of the perforations.
Alternate embodiments of
the device may also include the perforations and pull tabs separation
mechanism as described for
dressing 3926 in FIGS. 39A to 39E may also be adapted to this embodiment.
This particular alignment structure 4902 comprises a unibody structure with
three
interconnected alignment flanges 4908, 4910, 4912 along a base 4914 and base
opening 4916.
The opening 4916 is sized and shaped to form a mechanical interfit with the
applicator 4904, and
may be oval, circular, polygonal or other custom shape complementary to the
perimeter of the
applicator 4904. The base 4914 may also comprise a lip to increase the surface
of area of
attachment to the dressing 4900. Although interconnected along the base 4914,
in other
examples, the flanges may be separate from each other. In some further
examples, the flanges
4908, 4910, 4912 and/or base 4914 may be integrally formed with eat strain
support 4906. In
still other examples, the alignment structure 4902 may be provided separately
and is attached to
the strain support 4906 at the point-of-use. The alignment structure 4902 may
also be selected
from a plurality of different alignment structures, each configured for use
with a different
available infusion set applicator. The selected alignment structure is then
attached to the strain
support prior to use.
The attachment of the alignment structure 4902 may vary depending on the
material used
for the structure 4902 and the rigid support 4906. The alignment flanges 4910
and 4912 are
configured to provide a recess 4918 accommodate the infusion set tubing 4920,
and one or more
of the alignment flanges 4908 may comprise a gripping structures to facilitate
handling of the
dressing 4900, such as finger grips, recesses or ridges 4922. The alignment
flanges 4910 and
4912 may be further configured to be pulled apart to facilitate removal of the
alignment structure
4902 from the tubing 4920. After or concomitantly with the removal of the
alignment structure
4902, the strain support 4906 is removed to permit the dressing 4900 to
contract from the
strained configuration to its less strained configuration. In this particular
configuration of the
alignment structure 4902, the height of the flanges 4908, 4910, 4912 may be in
the range of
about 1-10 mm, 2-8 mm, or 3-6 mm, for example. The inner surfaces of the
flanges 4908, 4910,
4912 may be comprise an orthogonal orientation or may comprise a slight obtuse
angle, e.g. 91-
95 degrees, 91-100 degrees or 91-105 degrees, so that the initial placement of
the applicator
4904 itself does not require precise alignment but guides the applicator 4904
to a more precise
location with further insertion. The spacing of the flanges 4908, 4910 and
4912, in addition to
accommodating the tubing 4920, may also be configured to provide access to the
sides of the
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applicator 4904, which may also have finger grips 4936, so that the actuator
4924 of the
applicator 4904 is not used to position the applicator 4904.
The shape of the dressing 4900 may be any of a variety of shapes, including
but not limited
to an oval, circular or polygonal shape. Likewise, the access opening 4926 may
also comprise an
oval, circular or polygonal shape, and sized to accommodate the catheter of
the infusion set. The
access opening 4926 may comprise a diameter or transverse dimension in the
range of 1-20 mm,
2-10 mm, or 3-5 mm, for example. The alignment structure 4902 may comprise a
polymeric
material that may be thermoformed or injection molded, 3D printed or CNC
machined.
The skin adhesive on the dressing configured to attach to the skin or tissue
may be the
same or different adhesive used to attach the strain support to the dressing.
In some examples,
the skin adhesive may be selected with a greater T-peel force than the
adhesive used to attach the
support. In other examples, the adhesive used to attach the support may have a
higher T-peel
force. A higher T-peel force may be selected where the predetermined strain in
the dressing is
needed to resist strain loss during storage of a pre-strained device. A
protective or adhesive
release sheet may be applied to the skin adhesive to protect the skin adhesive
against
unintentional adhesion during storage or application. Coatings on the release
sheet and the
dressing may also be provided to facilitate peeling or removal of the release
sheet and the strain
support during use.
Referring to FIG. 50A, the dressing 4900 and alignment structure 4902 is
applied and
adhered to the selected target site. The adhesive liner of the infusion set
held by the applicator
4904 is removed and the applicator 4904 is aligned with alignment structure
4902, with the
tubing 4920 and the finger grips 4922 of the infusion correctly oriented to
the recesses. The
applicator 4904 is then inserted into the opening of the alignment structure
4902 until it is fully
seated, as illustrated in FIG. 50B. In some variations, visual indicia on the
alignment structure
4902, tactile feedback may be provided to confirm to the user that the
applicator 4904 is fully
seated. In FIG. 50C, the actuator 4924 of the applicator 4904 is depressed to
insert the
needle/cannula of the infusion set through the opening of the dressing 4900
and into the skin.
The actuator 4924 is then activated a second time to decouple the applicator
from the infusion set
hub 4938. In this particular example, the actuator 4924 comprises an outer
annular button 4930
and an inner button 4932 to separately deploy the needle/cannula and to
decouple but not yet
separate the applicator 4904.
Next, the alignment structure 4902 and the dressing support 4906 are removed
from the
dressing 4900 by applying downward pressure on the released applicator 4904 as
the alignment
structure 4902 and support 4906 are pulled away. To facilitate their removal,
the support 4906
may comprise a perforation 4934 that can be torn so that the alignment
structure 4902 and
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support 4906 may be peeled or pulled off, so that the dressing 4900 can
contract from its strained
configuration, In other variations, as shown in FIG. 51, the support 5100 of
the alignment
structure 5102 may comprise an arcuate configuration with a tabbed end 5104
that may be
grasped and used to pull out the support 5100 and alignment structure 5102
from the periphery
of the applicator 5106 and the tubing 5108. This then separates the infusion
hub 4938 from the
applicator 4904, and the rigid support 4906 from the dressing 4902, which
allows the dressing
4902 to contract from its pre-strained configuration.
FIGS. 48A to 48E depict example of an infusion system 4800 with a delivery
device 4802
that releasably holds an infusion hub 4804 with a pre-attached radially pre-
strained skin
tensioning device 4806. The delivery device 4802 comprises a body 4808 and
actuator 4810,
similar to the delivery system 3900 in FIG. 39A. The pre-attached radially pre-
strained skin
tensioning device 4806 comprise a radially outward strained adhesive elastic
layer 4812 that is
maintained in the pre-strained state by a semi-rigid strain support 4814a,
4814b that may
comprise a semi-rigid or rigid card stock or polymer layer that is adhered to
the top surface of
the elastic layer. Although this particular embodiment comprises a strain
support with two
sections 4814a and 4814b, in other examples, a single support may be provided,
or a 3, 4 or 5
part support may be provided.
After the infusion system 4800 is applied to the desired anatomical location,
and the
actuator 4810 is activated, the infusion hub 4804 is released and can be
separated from the
delivery body 4808, leaving the infusion hub 4804 and skin tensioning device
4806 attached to
the anatomical location, as illustrated in FIG. 48E. The function and patency
of the infusion
tubing 4816, hub 4804 and catheter 4818 may be checked. If functioning
correctly, the strain
support 4814a and 4814b may be removed or separated from the elastic layer
4812, which will
then radially compress the adhered skin or tissue toward the center of the
elastic layer 4812
around the hub 4804 and catheter 4818. The function and patency of the
infusion tubing 4816,
hub 4804 and catheter 4818 is then rechecked before initiating therapy. In
some variations, a
radially strained skin tensioning device may reduce the risk or rate of
kinking or occlusion of the
catheter 4818 in comparison to skin tensioning devices strain along a single
strain axis. The
shape of the elastic layer 4812 may be circular as depicted in FIGS. 48A to
48E, but in other
examples, the elastic layer may be oval, oblong, square, rectangular, star or
other shape An oval
or oblong shape may be used when the catheter is not orthogonally inserted
into the tissue, but
rather inserted along an acute angle to the treatment site, where the forces
acting on the catheter
or infusion hub may not be radially symmetrical.
In an embodiment, a dressing with an integrated infusion set is provided. The
device may
be used, for example, to treat, minimize, or slow the progression of
subcutaneous growth or
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lipohypertrophy in subjects provided with infusion therapy as described in
more detail herein.
The infusion set is removable from the dressing. After a period of time, for
example, after the
infusion set life cycle has finished, the infusion set may be detached from
the dressing. The
tensioned dressing substrate may then remain attached to the subject for an
additional period of
time without the catheter indwelling in skin.
In an embodiment, the integrated infusion pump and dressing include a dressing
substrate
with a dressing attachment structure with attachment features that allow the
infusion set to be
attached, for example, during manufacture or assembly, and may be provide for
user separation
of the infusion hub, or a portion thereof, of an infusion set, from the
dressing with the release
structure. The device may provide for permanent removal of an infusion hub to
prevent reuse of
the infusion set or infusion hub with the dressing. All or a portion of the
attachment structure or
structures may remain on the dressing when the infusion hub is separated.
Attachment structures may include for example a dressing attachment structure
attached to
a dressing substrate. A dressing attachment structure may be, for example, a
physical structure
that may or may not, in whole or in part be removed from a dressing when
release structures are
used to release the infusion hub. The attachment sheets or structures, and
related features
thereof, may be the same or similar as those described for FIGS. 1A to 22B,
including but not
limited to the attachment sheets used for dressing assemblies 100, 210, 320,
610, 810, 910 and
1000.
Release structures or releasable attachment structures may include but are not
limited to
pockets and tabs, hook and loop mechanism, hooks, angled bars, pivoting,
rolling, rocking or
sliding features associated with or coupled to attachment structures ,
adhesives, removable
adhesives, adhesive tapes or other adhesive devices, pegs, rip string, towel
bar configurations,
sliding pins, friction locks, cam locks, vacuum or suction devices, snap
connectors, carpet tack,
press fit connections or other connections, levers, latches, locking members,
spring members, for
example, or other mechanisms such as cutters or rip string or other structures
or features to
facilitate tearing, cutting or separation of attachment structures or elements
perforated or
otherwise severable structures, that permit removal of dressing from the
applicator, packaging,
other portions of the dressing assembly and/or attachment structures,
features, elements or
portions They may be self-releasing latches or spring members. The release
assembly may be
integrated in the dressing assembly and/or applicator, or may be provided
separately to be used
with the dressing assembly. They may be actuated when a pressure member is
applied to a skin
treatment device prior to removing the applicator. They may be manually
actuated.
The dressing and infusion set may comprise an infusion hub that is configured
to receive
an infusion housing or connector. The infusion set may additionally include
the infusion housing
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or connector. These treatment systems may be all-in one infusions sets
integrated into the
dressing. They may be manufactured together, rather than assembled by the
clinician at the
point-of-use, as described for other embodiments herein.
Referring to FIGS. 66A to 66H, a system 6600 is illustrated comprising a
dressing 6610
and an infusion set 6650. The infusion set 6650 includes an infusion set
housing or connector
6660 with infusion tubing 6661 and release elements 6662 for releasing the
housing 6660 from
an infusion hub 6670 and attached catheter 6680. By actuating or squeezing the
release elements
6662, the housing 6660 may be unlatched from the hub 6670, or the friction
between the housing
6660 and hub 6670 may be reduced to facilitate removal and separation. Fluid
communication
between the lumen of the tubing 6661 may be provided via an opening or channel
in the hub
6670, which may include a seal therebetween.
The dressing 6610 includes a substrate 6620, an attachment element 6630 and an
opening
6640 in the dressing 6610 for receiving the catheter 6680. The attachment
element 6630 is
attached on opposing sides 6632a, 6632b to the substrate 6620, for example
with an adhesive,
bond or other attachment mechanism. The attachment sheet, structure or element
6630 further
includes a removable portion or element 6633 having a release or decoupling
element, for
example, a pull tab 6634 and tear structures or elements 6635 (e.g., tear
lines, weakened sections,
perforations or other tear elements) extending through the attachment element
6630 adjacent
sides 6632. In some variations, the removable portion or element 6633 may lack
any attachment
to the underlying dressing substrate 6620. In other variations, the removable
portion or element
6633 may be attached to the surface of the dressing substrate via non-adhesive
static forces or
Van der Waals forces, or with a differential adhesive, such as a hybrid or
compound
silicone/acrylic adhesive. The hub 6670 of the infusion set is attached to the
removable element
6633 for example by way of an adhesive, bond, mount or attachment element.
FIGS. 66C to 66H illustrate the use of the system 6600. As shown in FIG 66E,
the
dressing 6610 is placed on and attached or adhered to a subject with the
infusion set 6650
attached to the dressing 6610 and the catheter 6680 extending through the
opening 6640 in place
in a subject. The dressing substrate 6620 may be attached, for example, by way
of a skin
adhesive, to the skin of a subject and may be removed by peeling from the skin
when desired.
When it is desirable to do so, the infusion set housing 6660 may be removed by
actuating the
release elements 6662. The infusion hub 6670 and catheter 6680 may remain
attached to the
subject with the dressing 6610. The same or a different infusion set housing
6660 may be
reattached to the hub 6670 if additional infusion treatment is desired. As
shown in FIGS. 66C
and 66G, when the infusion set is to be permanently removed, the hub 6670 is
removed by
grasping and pulling the pull tab 6634 and tearing the removable element 6633
along tear
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elements or lines 6635. As shown in FIGS. 66D and 66H, the pull tab 6634 is
pulled or actuated
until the removable element 6633 is separated by way of tear structures 6635,
e.g., the
perforations or tear lines 6635 from the dressing substrate 6620. The dressing
substrate 6620
may then remain attached to the subject for an additional period of time
without the infusion set
indwelling in skin.
Referring to FIGS. 67A to 67C, a system 6700 is illustrated comprising a
dressing 6710
and an infusion set 6750. The infusion set 6750 includes an infusion set
housing or connector
6760 with infusion tubing 6761 and release elements 6762 for releasing the
housing 6760 from
an infusion hub 6770 and attached infusion conduit, e.g. needle or catheter
6780. The dressing
6710 includes a substrate 6720, and an opening 6740 in the dressing 6710 for
receiving the
catheter 6780.
The infusion hub 6770 of the infusion set 6750 is configured to receive the
infusion set
housing 6760 and to provide fluid communication between the tubing 6761 of the
infusion
housing 6760 and the infusion conduit 6780. The device 6700 further includes
an attachment
structure 6772 for attaching the infusion hub 6770 to the dressing substrate
6720.
The attachment structure 6772 may include one or more substrate attachment
sections 6773
attached to the substrate 6720, for example with an adhesive, chemically
bonded, heat welded, or
other attachment mechanism. The attachment structure may further include
release elements or
release structures. For example, the attachment structure 6772 further
includes a removable
section 6774 coupled to or integral with the infusion hub 6770. The attachment
structure 6772
further includes tear elements 6775 (e.g., tear lines, breakable elements,
weakened sections,
perforations or other detachment elements) coupling the removable section 6774
to the one or
more substrate attachment sections 6773.The attachment structure's substrate
attachment
sections 6773, removable section 6774, tear elements 6775 may be constructed
of a single
unibody material.
The attachment structure 6772 may comprise a split ring attachment structure
that allows
the dressing to apply compression to the insertion area. The split ring
attachment structure may
be made of a soft plastic to reduce rigidity of the dressing and reduce
interference with a
subject's clothing and to minimize discomfort when wearing a large rigid
element on skin. The
removable section 6774 may be a circular flange formed with or attached to the
infusion hub
6770. The substrate attachment elements 6773 may be arced elements attached to
the circular
flange with frangible, breakable or tear elements 6775.
In use, the dressing 6710 is placed on and attached or adhered to a subject
with the infusion
set 6750 attached to the dressing 6710 and the catheter 6780 extending through
the opening 6740
in place in a subject, as depicted in FIG 67A. The dressing substrate 6720 may
be attached, for
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example, by way of a skin adhesive as described elsewhere herein, to the skin
of a subject and
may be removed by peeling from the skin when desired.
As illustrated in FIG. 67B, during use of the infusion set 6750, the infusion
set housing
6760 may be placed on or removed from the infusion hub 6770 for example
actuating the release
elements 6762 As shown in Figure 67C, when the infusion set 6750 is to be
permanently or
entirely removed, the hub 6770 is removed by twisting the hub 6770 and
breaking the tear
elements 6775. The removable section 6774 including catheter 6778 may then be
separated from
the attachment sections 6773. The dressing substrate 6720 may then remain
attached to the
subject for an additional period of time without the catheter indwelling in
skin.
Referring to FIGS. 68A to 68F, a system 6800 is illustrated comprising a
dressing 6810
and an infusion set 6850. The infusion set 6850 includes an infusion set
housing or connector
6860 with infusion tubing 6861 and release elements 6862 for releasing the
housing 6860 from
an infusion hub 6870 and attached catheter 6880.
The dressing 6810 includes a substrate 6820, an attachment element 6830 and an
opening
6840 in the dressing 6810 and aligned opening 6837 in the attachment structure
6830, for
receiving the catheter 6880. The attachment element 6830 is attached on
opposing sides 6832 to
the substrate 6820, for example with an adhesive, bond or other attachment
mechanism. The
attachment element 6830 further includes a release element, for example, a
circular perforation
or tear section 6835 (e.g., having tear lines, weakened sections, perforations
or other tear
elements) around the opening 6837. The circular tear section 6835 generally
aligns with the
circumference 6877 of the infusion hub 6870 where the infusion hub is attached
to the
attachment element 6830, e.g., with an adhesive, glue, bond or other securing
structure 6834.
Referring to FIG. 68A, in use, the dressing 6810 is placed on and attached or
adhered to a
subject with the infusion set 6850 attached to the dressing 6810, and the
catheter 6880 extending
through the opening 6840 and in place in a subject. The dressing substrate
6820 may be
attached, for example, by way of a skin adhesive, to the skin of a subject and
may be removed by
peeling from the skin when desired.
During use of the infusion set 6850, the infusion set housing 6860 may be
placed on or
removed from the infusion hub 6870, for example, by actuating the release
elements 6862. As
shown in FIGS. 68C and 68D, the infusion set housing 6860 is removed. In FIG.
68E, when the
infusion set 6850 is to be permanently or entirely removed, the hub 6870 is
removed by twisting
the hub 6870 and separating the hub 6870 at the perforations 6875. The hub
6870 including
catheter 6880 may then be separated from the dressing substrate 6820 and
remaining portions of
the attachment element 6830, as depicted in FIG 68F. The dressing substrate
6820 may then
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remain attached to the subject for an additional period of time without the
catheter indwelling in
skin.
Referring to FIGS. 69A to 69K, a system 6900 is illustrated comprising a
dressing 6910
and an infusion set 6950. The infusion set 6950 includes an infusion set
housing 6960 with
infusion tubing 6961 and release elements 6962 for releasing the housing 6960
from an infusion
hub 6970 with attached catheter 6980. The dressing 6910 includes a substrate
6920, and an
opening 6940 in the dressing 6910 for receiving the catheter 6980. A dressing
connector 6925
is attached to the dressing 6910 and is configured to releasably couple the
infusion hub 6970 to
the dressing 6910.
The infusion hub 6970 of the infusion set 6950 is configured to reversibly
receive the
infusion set housing 6960 and provide fluid communication between the tubing
6961 of the
infusion housing 6960 and the infusion conduit 6980. Tubing 6961 is
fluidically joined to a
lumen 6963 of the housing 6960 which terminates inwardly at a fluid seal 6963,
e.g a silicone
seal or grommet. When the infusion housing 6960 is coupled to the infusion hub
6970, the fluid
seal 6963 is configured to align and seal with the fluid seal 6963 of the
lumen 6982 of the hub
6970. This lumen 6982 communicates with the infusion conduit 6980. In
embodiments wherein
the infusion conduit 6980 comprises a soft cannula or catheter, an additional
needle lumen 6982
and self-sealing needle seal 6983 may be provided to allow a solid needle or
trocar (not shown)
of an applicator to provide mechanical support and ability to pierce tissue,
in order to facilitate
insertion of the infusion conduit. The needle lumen 6982 may be oriented to
provide a linear
insertion and withdrawal path of the solid needle or trocar through the
infusion conduit 6980.
The solid needle or trocar is then withdrawn from the infusion conduit 6980
with the applicator
once insertion of the conduit 6980 is completed. A complementary mechanical
interfit between
the interior cavity shape of the infusion housing 6960 and the outer shape of
the hub 6970 may
be provided to facilitate alignment of the fluid seals and lumens. In some
other variations, a
sealed circumferential recess or channel may be provided on the interior
surface of the housing
and/or the outer surface of the hub with seals, to allow fluid communication
between the housing
and hub that is independent of the angular orientation of the housing, and
therefore not require
angular alignment. These various fluid channel configurations may be adapted
to provide fluid
communications with the other infusion sets described herein that have
separable infusion
housings and hubs, including systems 6600, 6700, 6800 and 7000.
The infusion hub 6970 includes an attachment structure 6972 for attaching the
infusion hub
6970 to the dressing connector 6925. The infusion hub 6970 further includes a
release element,
for example, a removable attachment section 6974 coupled to or integral with
the engagement
element 6971. The attachment structure 6972 may comprise a flange 6975 having
bendable arms
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6973 with extension tabs 6976 configured to engage the dressing connector
6925.The dressing
connector 6925 may include one or more connector sections 6926 attached to the
substrate 6920,
for example with an adhesive, bond or other attachment mechanism 6927. The
dressing
connector 6925 may comprise a split ring attachment structure that allows the
dressing 6910 to
apply compression to the insertion area. The split ring attachment structure
may be made of a
soft plastic to reduce rigidity of the dressing and reduce interference with a
subject's clothing.
The connector sections 6926 comprise recesses or cutouts 6929 configured to
receive
extension tabs 6976 of the infusion hub 6970 along an orthogonal direction to
the treatment
surface. Cutouts 6929 are in communication with transverse slots 6928 for
rotatably receiving
extension tabs 6976. Cutouts 6929 at the end of the slots 6928 are configured
to lock the
extension tabs 6976 in place.
As shown in FIGS. 69A and 69B, in use, the dressing 6910 is placed on and
attached or
adhered to a subject with the infusion set 6950 attached to the dressing 6910
and the catheter
6980 extending through the opening 6940 in place in a subject. The dressing
substrate 6920 may
be attached, for example, by way of a skin adhesive, to the skin of a subject
and may be removed
by peeling from the skin when desired.
In FIG. 69C, during use of the infusion set 6950, the infusion set housing
6960 may be
placed on or removed from the infusion hub 6970 for example actuating the
release elements
6962. When the infusion set 6950 is to be permanently or entirely removed, the
hub 6970 is
removed by a) depressing the bendable arms 6973 to release the extension tabs
6976 from the
cutouts 6929, b) twisting or turning the hub 6970 to move the extension tabs
6976 through the
slots 6928 to openings 6927, and c) lifting the hub 6970 to detach it from the
dressing connector
6925 and dressing 6910, per FIG. 69E. The dressing substrate 6920 may then
remain attached
to the subject for an additional period of time without the catheter
indwelling in skin, as in FIG.
69F.
FIG. 69K depicts an exemplary configuration of fluid channels providing fluid
communication between the catheter tubing 6961 and the fluid conduit 6980, for
providing
insulin therapy or other infused therapy. Seals, such as silicone rings 6963
and
Referring to FIGS 70A to 70K, a system 7000 is illustrated comprising a
dressing 7010 and
an infusion set 7050. The infusion set 7050 includes an infusion set housing
7060 with infusion
tubing 7061 and release elements 7062 for releasing the housing 7060 from an
infusion hub 7070
with attached catheter 7080. The dressing 7010 includes a substrate 7020, and
an opening 7040
in the dressing 7010 for receiving the catheter 7080. A dressing connector
7025 is attached to
the dressing 7010 and is configured to releasably couple the infusion hub 7070
to the dressing
7010.
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The infusion hub 7070 further includes: an outer engagement hub 7071; tool
receptacles
7072 from the superior side through the inferior side of the infusion hub
7070; and a central
section 7073. The central section 7073 includes an opening 7074 through which
infusion fluid is
delivered from infusion tubing 7061 to the catheter 7080. The central section
7073 also includes
spring arms 7076 with connector tabs 7077 extending into and through tool
receptacles 7072.
An inner wall of the outer engagement hub 7071 includes a cut out edge section
7079 of the hub
for attaching a removal tool 7090 tool to the infusion hub 7070.
The dressing connector 7025 includes a hub receptacle opening 7026 for
receiving the
central section 7073 (including connector tabs 7077) of the infusion hub 7070.
The hub
receptacle opening 7026 is in communication with a catheter opening 7027 for
receiving the
catheter 7080. The openings 7026, 7027, and 7074 are further aligned with the
opening 7040 in
the dressing substrate 7020, so that when the system is assembled, the
catheter 7080 extends
through opening 7040 in dressing 7010. The attachment structure may comprise a
dressing
connector 7025 further includes engagement tabs 7028 that receive connector
tabs 7077 at the
ends of the spring biased arms 7076 when the infusion hub 7070 is attached
with the dressing
connector 7025 to the dressing 7010.
The dressing 7010 with integrated infusion set 7050 is shown assembled in FIG
70A. The
infusion set housing 7060 is coupled by way of engagement hub 7071 to the
infusion hub 7070
and is released using release elements 7062. The infusion hub 7070 is attached
to the dressing
7010 by way of the dressing connector 7025. The catheter 7080 is placed
through openings 7027
and 7040 respectively in the hub 7070 and dressing 7010. The central portion
7073, spring arms
7076 with tabs connector tabs 7077 are positioned through the opening 7026.
The spring arms
7076 are biased outward so that the connector tabs 7077 engage the engagement
tabs 7028 when
the arms 7076 are pushed into the opening 7026.
In use, the dressing 7010 is placed on and attached or adhered to a subject
with the infusion
set 7050 attached to the dressing 7010 and the catheter 7080 extending through
the opening 7080
in place in a subject, as shown in FIG. 70A. The dressing substrate 7020 may
be attached, for
example, by way of a skin adhesive, to the skin of a subject and may be
removed by peeling
from the skin when desired.
In FIG. 70B, during use of the infusion set 7050, the infusion set housing
7060 may he
placed on or removed from the infusion hub 7070 for example actuating the
release elements
7062.
When the infusion set 7050 is to be permanently or entirely removed, the hub
7070 is
removed by using the release structure or removal tool shown in Figure 70J.
The removal tool
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7090 includes a handle portion 7091 with distal spring-loaded prongs 7092
having attachment
tabs 7093.
The prongs 7092 and attachment tabs 7093 are inserted into the receptacles
7072 in the hub
7070 deflecting the spring arms 7076 inward, disengaging connector tabs 7077
from engagement
tabs 7028. The attachment tabs 7093 of the removal tool 7090 engage the cut
out edge section
7079 of the infusion hub 7070 attaching the tool 7090 to the infusion hub
7070. The infusion
hub 7070 may then be removed from the dressing 7010 using the tool.
The dressing substrate 7020 may then remain attached to the subject for an
additional
period of time without the catheter indwelling in skin.
The substrates of the dressings 6610, 6710, 6810, 6910, and 7010 may be
flexible and
resilient or may be relatively inflexible. According to one variation the
dressing may be strained
prior to application. The dressing may be provided in a pre-strained
configuration as described
detail herein. herein. The dressings 6610, 6710, 6810, 6910, and 7010 may
include a removable
applicator and strain support configured to maintain the strain in the
strained elastic layer of the
dressing substrate, as depicted in the examplary embodiment in FIG. 39B. Other
applicator and
The systems 6600, 6700, 6800, 6900, and 7000 may also include a removable
applicator as
described herein. The strain support may be used as an applicator. Exemplary
embodiments of
applicators, strain supports, tension supports and dressing supports that may
be used or
incorporated with these dressings include those described for dressings or
infusion systems 3006,
3921, 4500, 4800, 4900 and 5200 described elsewhere herein.
In addition to a radially strained infusion system 4800, a radially pre-
strained skin
tensioning device 5500 may be provided for use with manual injection with a
syringe 5502, as
shown in FIGS. 55A and 55B. The skin tensioning device 5500 comprises an
elastic layer 5504
with an access opening 5506. The skin tensioning device 5500 may be adhered to
the target
location and then the radial strain supports 5508a, 5508b may be removed to
permit the elastic
layer 5504 to radially compress the underlying skin toward the access opening
5506. The access
opening may comprise a diameter or a shape with a transverse dimension in the
range of 1-20
mm, 2-10 mm, or 3-5 mm, for example.
Referring to FIGS. 56A and 56B, in some other variations of a skin tensioning
device
5600, whether radially strained or single-axis strained, the access opening
5602 of the device
may comprise a fabric patch 5604. The patch 5604 may be configured with a
woven fabric that
permits the needle 5606 of the syringe 5608 to still pass through the access
opening 5602 while
providing some physical coverage of the injection site. The increased
breathability may extend
to use time of the device 5600. The fabric patch 5604 may provide increased
water vapor transfer
across the skin tensioning device 5600 and may also be used to absorb an
excess insulin that may
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leak from the injection site. The fabric patch 5604 may be coated, infused or
woven with an
anti-infective agent, such as an antibiotic or silver strands. The fabric 5608
may comprise a
nylon, non-woven cotton, polyester or polypropylene, an elastic polymer blend,
or silver
alginate, for example.
In still another alternative embodiment, a skin treatment system 5400
comprising a tension
off-loading dressing 5402 but instead of an access opening or fabric patch, an
injection port 5404
is provided on the dressing 5402, as shown in FIGS. 54A and 54B. The dressing
5402 and port
5404 may be provided with any of the applicators as described herein, noting
that the region of
the dressing 5402 attached to the port 5404 will not under the same strain as
the portion of the
dressing 5402 peripheral to the port 5404. The injection port 5404 includes a
catheter 5406 such
that syringes attached to the port 5402 or syringe needles inserted into the
port are able to deliver
therapeutic agents through the catheter 5406 and into the skin or tissue. Use
of the port may
reduce pain or discomfort associated with therapy, compared to direct needle
injection
Referring to FIGS. 41A to 43C, in another embodiment, an infusion set 4100 and
a multi-
layer tensioned dressing 4102 may be used for subcutaneous infusion or
intravascular infusion.
The infusion set 4100 comprises an infusion tubing 4104 that is connectable to
an infusion
source or pump, such as an insulin pump or other therapy pump, and is in fluid
communication
with an internal cavity of an infusion housing 4104 which is in turn in fluid
communication with
a subcutaneous needle or catheter 4106 which is inserted into the tissue or
vasculature. The
bottom surface of the infusion housing 4104 is adhered or attached to the top
layer 4108a of the
multi-layer tensioned dressing 4102. Each of layers 4108a to 4108c comprises a
perimeter
4110a to 4110c that is sized to be smaller in size and is positioned within
and offset from the
perimeter 4110b to 4110d of the layer 4108b to 4108d immediately below it,
except for an
optional flap 4112a to 4112c. The elasticity of the top and intermediate
layers 4108a, 4108b,
4108c may be configured to be lower than the modulus of elasticity of the base
elastic layer
4108d. The base layer 4108d may also have a higher durometer (e.g. 60 Shore A
vs. 50 Shore A
vs. 30 Shore A) or comprise a thicker material (e.g. 10 mil vs. 7 mil vs. 5
mill vs. 0.5 mil)
compared to the other layers 4108a-c. In other variations, the non-base layers
may comprise
holes or perforations to reduce the total cross-sectional area of the non-base
layer, which can
reduce the amount of strain contributed from the non-base layers. With this
configuration, the
compressive force per unit width results primarily from the contribution of
the base elastic layer
4108d, about 50%, 60%, 75%, 90% or any range between any two of these
contribution
percentages. Based on this, the amount of adhesion strength between the layers
may be
relatively lower than the bond strength between the skin and the base layer
4108d. The adhesive
of layers 4108a to 4108c, may also be pattern coated onto the layers 4108a to
4108c to facilitate
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peeling in a direction orthogonal to the strain. For example, multiple narrow
strips of adhesive
may be provided in the direction of the peel. The width of the adhesive
orthogonal to the
direction of the strain in the elastic member may be 0.1", 0.165", 0.2", 0.3"
or or any range
between any two of such widths. In another examples, an adhesive pattern may
be provided
where less adhesive is peel direction as compared to the strain direction,
e.g. 20% less, 40% less,
60% less, 80% less, or a range between any two of these percentages, or other
type of anisotropic
adhesive pattern. The interlayer adhesives used to join all of the layers
4108a-d together may
comprise a lower thickness compared to the skin adhesive (e.g. 0.5 mil, vs.
0.25 mil, vs. 0.1 mil).
In other variations, an adhesive with a high-tensile strength but low shear
strength may be used,
to facilitate removal of an upper layer of the multi-layer tensioned dressing
by pulling the layer
or adhesive layer laterally rather than upward. This nested configuration
results in a stepped
dressing profile, as depicted in FIGS. 44A and 44B, which may redistribute
edge stresses of a
skin tensioning device across a greater surface area, rather than concentrate
them at the edge of a
single layer skin tensioning device. In some variations, the separation
between the perimeters
4110a to 4110d of adjacent layers 4108a to 4108d may be uniform along the
entire perimeter,
e.g. a uniform perimeter difference in the range of 1 to 5 mm, 2 to 5 mm, or 2
to 4 mm, or 2 to 3
mm, for example. In some further examples, the uniform perimeter difference
between two
adjacent layers 4108a to 4108d is the same for every two adjacent layers 4108a
to 4108d. In
other examples, the uniform perimeter difference may be different between at
least one pair of
two adjacent layers. For example, the perimeters 4110a and 4110b may be the
same as 4110b
and 4110c, but the uniform perimeter difference between layers 4110c and 4110d
may be smaller
or larger then uniform perimeter difference of the other pairs of layers 4108a
to 4108c. Layer
4108d in FIGS. 41A does not have a flap, but in other embodiments may also be
provided with a
flap. The flaps 4112a to 4112c may or may not comprise adhesive on its
inferior surface, which
may facilitate separation and grasping of the flap 4112a to 4112c from the
other layers for
removal. Each of the layers 4108a to 4108d also comprises a center opening
(not shown)
through which the needle or catheter 4106 of the infusion set 4100 may be
inserted. This nested
layer configuration of the multi-layer dressing 4102 may not have a flap The
flexible attachment
sheet 4108 is sized and configured with a perimeter 4112 that is smaller than
a perimeter 4114 of
the multi-layer tensioned dressing 4102.
Although the exemplary embodiment depicted in FIGS. 41A and 41B comprises a
four-
layer skin tensioning device 4102, in other examples, the skin tensioning
device may comprise
two, three, five or more layers. The infusion set 4100 and the skin tensioning
device 4102 may
be pre-assembled at the point of manufacture, assembled at the point-of-use,
or assembled
serially at the treatment site, with the skin tensioning device 4102 place
first, followed by the
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infusion set 4100 through and onto the skin tensioning device 4102. The
applicator for the skin
tensioning device 4102 may be the book-type applicator as described herein. In
another
variation, the infusion device 4100 may be pre-attached to one flexible layer
of adhesive material
larger than the infusion set housing 4104 and comprises a similar material and
adhesive as the
layers of the multi-layer skin tensioning device. During use, the skin
tensioning device is
strained and applied to the skin, but the infusion device 4100 and its pre-
attached flexible layer
of material are not strained when applied to the multi-layer skin tensioning
device.
As depicted in FIGS. 42A to 43C, when the infusion set 4100 needs to be
replaced, e.g.
due to occlusion or to reduce the risk of infection, the flap 4112a of the top
layer 4108a may be
grasped and then lifted up to separate the adhesive of the top layer 4108a
from the intermediate
layer 4108b, or to otherwise peel away the top layer 4108a from the
intermediate layer 4108b,
thereby also lifting up the infusion 4100 up with the top layer 4108a, and
pulling out the catheter
4106 from the skin, while leaving the other layers 4108b-d of the multi-layer
skin tensioning
device on the skin, thereby minimizing the frequency that the adhered skin
tensioning device is
separate from the skin. This may reduce irritation of the underlying skin from
repeated removal
of an adhered device. Once the infusion set 4100 is removed along with the top
layer 4108a, a
new infusion set 4100 may be applied to directly to the intermediate layer
4108b, by aligning the
delivery location of the catheter 4106 of the new infusion set 4100 with the
opening 4114b of the
intermediate layer 4108b. This cycle of removal and reapplication may be
performed several
times equal to the number of layers in the skin tensioning device, with
subsequent cycles of new
infusion sets removed and applied to the next layer, with the base layer 4108d
also being used
and later removed with the final infusion set 4100.
Like other embodiments described herein, the skin adhesive on the bottom layer
of the skin
tensioning device may be the same or different adhesive used to attach the
strain support to the
dressing, and/or the adhesive used to attach the multiple layers of the skin
tensioning device
together. In some examples, the skin adhesive may be selected with a greater T-
peel force than
the adhesive used to attach the support. In other examples, the adhesive used
to attach the
support may have a higher T-peel force. A higher T-peel force may be selected
where the
predetermined strain in the dressing is needed to resist strain loss during
storage of a pre-strained
device. A protective or adhesive release sheet may he applied to the skin
adhesive to protect the
skin adhesive against unintentional adhesion during storage or application.
Coatings on the
release sheet, and layers of the dressing may also be provided to facilitate
peeling or removal of
the release sheet, the layers, and the strain support during use. The strain
support for this
embodiment may include the perforation and pull tab separation mechanism (not
shown) as
described for dressing 3926 in FIGS. 39A, to releasably maintain the strain
with at least layer
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4108d, but may also be configured to directly releasably maintain strain in
the other layers
4108a-c as well.
FIGS. 45A and 45B depict another example of an infusion set 4500 with a multi-
layer
dressing 4502 pre-attached to an infusion hub 4504, tubing 4506 and catheter
4508, but in this
variation, the lower layers 4510b-d are smaller than the adjacent upper layers
4510a-c. This
configuration is also a stepped dressing profile, which may redistribute edge
stresses of a skin
tensioning device across a greater surface area, rather than concentrate them
at the edge of a
single layer skin tensioning device. The base layer 4510d, however, has a
smaller adhered
surface area, and the upper layers 4510a-c are only adhered to the skin about
their periphery.
Like the embodiment depicted in FIGS. 41A to 44B, the separation between the
perimeters
4512a to 4512d of adjacent layers 4512a to 4512d may be uniform along the
entire perimeter,
e.g. a uniform perimeter difference in the range of 1 to 5 mm, 2 to 5 mm. or 2
to 4 mm, or 2 to 3
mm, for example. The uniform perimeter difference between two adjacent layers
4510a 4510b
may be the same for each two adjacent layers 4510a to 4510d, or may be
different. In other
examples, the uniform perimeter difference may be different between at least
one pair of two
adjacent layers. The layers 4510a-d may also comprise optional flaps 4514a-c,
to facilitate
grasping and removal of the layers 4510a-c. The other features of the device
may otherwise be
similar to the four-layer skin tensioning device 4102 in FIGS. 41A and 41B,
e.g. the heat staking
and adhesive configurations.
As depicted in FIGS. 46A to 47C, when the infusion set 4500 needs to be
replaced, e.g.
due to occlusion or to reduce the risk of infection, the flap 4514a of the top
layer 4510a may be
grasped and then lifted up to separate the adhesive of the top layer 4510a
from the intermediate
layer 4510b, or to otherwise peel away the top layer 4510a from the
intermediate laver 4510b,
thereby also lifting up the infusion hub 4504 up with the top layer 4108a, and
pulling out the
catheter 4108 out of the skin, while leaving the other layers 4510b-d of the
multi-layer skin
tensioning device 4502 on the skin. This minimizes the frequency that the
adhered skin
tensioning device 4502 is pulled off of the skin. This may reduce irritation
of the underlying
skin from repeated removal of an adhered device 4502. Once the infusion hub
4504 is removed
along with the top layer 4510a, anew infusion set 4500 may be applied to
directly to the
intermediate layer 4510b, by aligning the delivery location of the catheter
4508 of the new
infusion set 4500 with the opening 4516 of the intermediate layer 4510b. This
cycle of removal
and reapplication may be performed several times equal to the number of layers
in the skin
tensioning device, with subsequent cycles of new infusion sets removed and
applied to the next
layer, with the base layer 4510d also being used and later removed with the
final infusion set
4100. The strain support for this embodiment may include the perforation and
pull tab separation
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mechanism (not shown) as described for dressing 3926 in FIGS. 39A, to
releasably maintain the
strain with at least layer 4510d, but may also be configured to directly
releasably maintain strain
in the other layers 4510a-c as well.
In another embodiment, a skin tensioning system for treating a therapy
injection or
infusion site may comprise a pair of tension dressings 5200 and 5202, as
depicted in FIG. 52.
Each of the dressings 5200 and 502 may be provided a dressing tension
applicator (not shown)
as described herein, e.g. book applicator. The dressings 5200, 5202 may have
separate
applicators, but in some embodiments, may be provided on the same applicator
with a
predetermined spacing or gap 5204 between the dressings 5200, 5202 as
configured in the
applicator. During use, or as supplied in the applicator, the gap 5204 may be
in the range of
about 1-20 mm, 2-10 mm, 3-8 mm, 4-6 mm, for example. Each of the dressings
5200, 5202 are
tensioned along a tensioning axis 5206, 5208, if the dressings were not
pretensioned at the point-
of-manufacture. The applicator may also comprise visual alignment indicia so
that any
prespecified spacing or gap 5204 between the dressings 5200, 5202 may be
aligned or oriented
as needed to a particular injection or infusion site. Each of the dressings
5200, 5202 are placed
adjacent to the desired injection or infusion site 5210, on opposite sides of
the target site 5210.
Each dressing 5200, 5202 may comprise a treatment edge 5212, 5214 that are
aligned in a
parallel fashion to define the gap 5204 between the dressings 5200, 5202. The
gap 5204 on the
skin or on the applicator may be characterized by a longitudinal gap axis
5216, which may also
be parallel to the tension axes 5206, 5208 of the corresponding dressings
5200, 5202. After each
dressing 5200, 5202 is positioned about the target site 5210, the applicator
or strain support for
each is released, allowing the dressings 5200, 5202 to at least partially
relax and compress the
skin surrounding the target site 5210. This resulting skin compression is
generated at the target
site 5210 without any dressing completely surrounding or covering the target
site 5210, although
support of skin tension orthogonal to the tensioning axes 5206, 5208 and gap
axis 5216 is
reduced because the two dressings 5206, 5208 are completely separate along
that direction.
In still another embodiment, a skin tensioning dressing 5300 for treating a
therapy injection
or infusion site may comprise a pair of tension lobes or sections 5302 and
5304, as depicted in
FIG. 53. Each of the sections 5302 and 5304 are integrally formed with an
interconnect or
bridge 5306 and a separated by a section gap 5308_ The gap 5308 may be in the
range of about 1-
20 mm, 2-10 mm, 3-8 mm, 4-6 mm, for example. The dressing 5300 may be provided
with an
applicator as described elsewhere herein. Each of the dressing section 5302,
5304 are tensioned
along a tensioning axes 5310, 5312. The applicator may also comprise visual
alignment indicia
so that the gap 5308 may be aligned or oriented as needed to a particular
injection or infusion
site. Each of the dressing sections 5302, 5304 are positioned with the target
site is in the gap
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5308. After the dressing 5300 is located and adhered to the desired target
site, the applicator or
strain support is released, allowing the dressing sections 5302, 5304 to at
least partially relax and
compress the skin surrounding the target site.
Any of the skin tension off-loading devices corresponding to FIGS. 30A to 56B
may be
evaluated with proposed study designs to evaluate the effects of skin tension
offloading on
insulin pharmacokinetics, dosing, therapeutic efficacy, and/or the development
of
lipohypertrophy are described below, including potential health economic
benefits. Diabetes
patients cun-ently treated with insulin will be randomized to a treatment
group or control group,
with treatment comprising use of the skin tension offloading devices selected
from those
corresponding to FIGS. 30A to 56B may be used for 4 weeks to 5 years or more,
4 weeks to 2
years, 8 weeks to 1 year as described herein. The dressings or skin tension
offloading devices, or
a layer and/or infusion set may be changed every three days, or every 2 to 14
days, 3 to 10 days,
10 to 14 days, 5 to 7 days, 3 to 5 days, 2 to 3 days for the selected study
period.
It is hypothesized that applying a skin tension offloading device in a
substantially
continuous fashion may reduce the risk, progression or severity of a
lipodystrophy, including
lipohypertrophy in insulin-dependent patients. By reducing or limited the
development of
lipohypertrophy, dose progression or therapeutic effect variability relating
to lipohypertrophy
may be slowed or reduce. It is also hypothesized that some of the effects on
dose progression
and therapeutic effect variability may be independent of the development or
progression of
lipohypertrophy, and may be a direct result of the skin tension off-loading
device on tissue
mechanics and pharmacokinetics. The use of a skin tension offloading device
configured with
predetermined levels of strain will permit controlled and consistent delivery
of strain level and to
measure effects of different consistent levels of strain, compared to other
skin tensioning devices
that are manually adjusted in an ad hoc fashion, as with many sutureless wound
closure devices.
Initial studies may include patients with preexisting lipohypertrophy and/or
high daily insulin
dosing requirements, to more easily identify clinical effects. Using the long-
term data from the
studies, an outcome flowchart will be developed and costs per event will be
estimated so that a
cost-effectiveness and/or health economic analysis may be performed. In
conjunction with
patient quality of life measures, a quality-adjusted life-year cost may also
be calculated.
In one proposed study evaluating the effects of one or more of the tension
offloading
devices will be evaluated in insulin-dependent patients with preexisting
lipohypertrophy mass, to
assess whether the tension offloading devices can alter the pharmacokinetics
or delivery kinetics
of insulin to patients who inject or infusion insulin or an insulin analogue
to a site with pre-
existing lipohypertrophy. Diabetes patients will be screened for
lipohypertrophy masses in the
range of 6-10 cm and then randomized to have a tension offloading device
applied during the
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study. Each patient will be randomized to a test day where they will each
undergo two glucose
absorption tests after an overnight fast, where the tests are separated by a
minimum of 7 days and
an overnight fast before the tests. An indwelling catheter will be placed for
each patient to
provide blood samples for blood glucose and insulin levels during the test
period. Baseline
levels are measured and then each patient will receive a subcutaneous
injection of 10 units of
insulin through the access opening of the skin tension offloading device in
the treatment group,
or directly to the skin location in the control group. Blood samples will be
obtained every five
minutes for the first thirty minutes, then every ten minutes for the next 60
minutes, then every 30
minutes for the next 2.5 hours. The maximum concentration of plasma insulin at
each time
period will be determined as well as the time to maximum insulin
concentration, and the area
under the insulin concentration curve will be analyzed to assess any direct
effect of the skin
offloading device on insulin absorption.
In another proposed study, patients will be randomized to receive skin
offloading treatment
kits in conjunction with insulin or insulin analogue injection or infusion,
for use over a treatment
period of 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 6 months 9 months, 12
months, 18
months or 24 months, for example. The tension off-loading treatments will be
used as directed
with replacement of the device, or change in a laver of a multi-layer device,
every 2 days, 3 days,
4 days or 5 days, or as needed. Blood glucose will be measured at least 4
times per day, and
compliance with blood glucose measurements and use of tension offloading
devices will be
assessed. The analysis will be an intent-to treat analysis and the mean
amplitude of glucose
excursion will be calculated over the treatment period and the postprandial
area under the curve
will be calculated for each mealtime over the treatment period. Alternatively
or in addition,
hemoglobin A1C will be measured at baseline and at each follow-up to assess
the effects of the
skin tension offloading device. A health economic study and/or a patient
quality-of-life study
may also be included in the analysis.
Patient inclusion criteria may include one or more of the following:
- Patients with or without prior history of lipohyperdystrophy
- Patients with a lipohypertrophy mass in the range 5-10 cm
- Patients with high daily insulin dose requirements of a least 0.9 Ul per
Kg
- Patients with minimum insulin use of 50 IIJ/day
- Treatment with insulin or insulin analogue for at least one year prior to
enrollment
- Prior experience with rapid-acting insulin analog for at least 6 months
- Type I or Type II diabetic patients
- Treatment is self-administered or given by a caregiver
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- Current treatment includes at least two to four injections per day, or
insulin
pump use
- Body Mass Index in the range of 20 to 35 kg/m2.
- Stable body weight for 3 months prior to enrollment (<5% change in body
weight)
- Hemoglobin Al C < 8.5%
- C-peptide <0.6 nmol/L at screening
Patient exclusion criteria may include one or more of the following:
- Pre-existing lipodystrophy or lipohypertrophy
- Children under the age of 5 years
- Patient not currently treated with insulin or analogue
- Women with gestational diabetes
- History of hypoglycemic unawareness
- History of diabetic ketoacidosis within 6 months of screening
- History of cardiovascular disease
- History of arrhythmia
The primary and secondary endpoint(s) will assess the development or presence
of
lipohypertrophy and/or changes in blood glucose or blood glucose variability
factors at each
visit. The initial assessment and each follow-up visit will include evaluation
of:
- Serial ultrasound scans using a linear 20MHz probe using B-mode imaging:
o Classification:
= Simple subcutaneous hypertrophy
= Diffuse hyperechoic subcutaneous dystrophy
= Nodular hyperechoic dystrophy
= Focal and diffuse hyperechoic subcutaneous dystrophy
= Nodular hypoechoic subcutaneous dystrophy
= Subcutaneous atrophy
= Complex multilayer dystrophy
o Fibrosis level
= Is 0-hyperechogeni c
= Isoechogenic
= Iso-hypoechogenic
- Direct and tangential light inspection and color photography of the
treatment
site, against a dark background
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- Classification of the treatment site as to shape and size using palpation
and skin
calipers:
o Small nodule ¨ visible on inspection, easy to palpate with an elastic
consistency
o Large nodule ¨ clearly visible on inspection, easy to palpate, with a
hard to elastic consistency
o Flat plate ¨ slightly raised and somewhat visible, difficult to palpate
except with skin pinching, with an elastic consistency
o Flat nodule ¨ not visible but palpable on deep palpation or skin
pinching, with an elastic consistency
o Size, including <4 cm and > 4cm
- Clinical Grading, from zero to 3:
o 0 ¨ no changes
o 1 ¨ visible hypertrophy but normal consistency on palpation
o 2 ¨ substantial thickening and denser consistency
o 3 ¨ evidence of lipoatrophy
- Validated diabetes questionnaires (start and end of study only)
o Problem Areas in Diabetes Questionnaire
o Diabetes Treatment Satisfaction Questionnaire
At the end of the study, the percentage change in prandial insulin and total
daily insulin
dosing, time-in-range (70-140 mg/di) and out-of-range (<70 mg/dl and > 180
mg/dl) for studies
with patients using continuous glucose monitoring devices, hemoglobin AlC, the
number of
hypoglycemic events, the number of diabetic ketoacidosis events will be
calculated and
compared between the treatment and control groups. For studies involving
patients with CGM
or insulin pumps, pain assessments during cannula/infusion set insertion
removal,
cannula/infusion set malfunction (occlusion, needle deformation), will be
assessed and
compared.
In some further variations, the various tissue tension off-loading devices and
systems
described herein may be used for both a continuous subcutaneous insulin
infusion set (SCII) and
for a sensor of a CGM system, i.e. a closed loop therapy/sensing system, also
known as an
"artificial pancreas" or a double subcutaneous approach. It is hypothesized
that the tension off-
loading devices may promote a longer wear time, reduce physiologic or sensor-
based latency,
sensor drift for the infusion set and/or CGM sensor system, which may result
in improved
glucose control. This may be the result of reducing mechanical irritation or
inflammation at the
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infusion and/or sensor site, which may lead to fibrosis. CGM devices measure
glucose
concentrations in the interstitium. Interstitial glucose fluctuations relate
to blood glucose
presumably via diffusion. CGM calibration quality and inaccuracy from loss of
sensitivity and
random noise, are all affected by the time lag due to blood glucose to
interstitial glucose
transport.
In another proposed study, the effects of applying a tensioned tissue
treatment device to an
insulin injection or infusion site with lipohypertrophy will be analyzed.
Eligible participants will
include adults aged 18 to 70 years with type 1 diabetes taking insulin by
multiple daily injections
(at least three injections daily) for at least two years and who have at least
two distinct palpable
lipohypertrophy lesions on the abdomen for use for the injections. Each LH
lesion must be a
minimum of 3 cm in one dimension. LH lesions less than 2 years old will be
selected. Subjects
may or may not be using a continuous glucose monitor but will be asked to wear
a CGM as part
of the study protocol. HbAlc must be in the range of 7.5% to 10.5% at the
screening visit. A
punch biopsy of an LH lesion may be obtained at the start and at the last
study visit.
The initial examination and patient screening procedure may include a physical
examination for the LH lesions, with recordation of the LH dimensions.
CBC/chemistry blood
panels, urinalysis, HbAl c will be obtained. A CGM will be applied for 10 to
14 days to monitor
the patients.
Patients meeting eligibility criteria return for the next visit, where the CGM
data is
downloaded to capture glycemic profiles establish baseline blood glucose and
insulin use. A
punch or needle biopsy of one of the lipohypertrophy region is performed and
closure is
performed, if needed, with sutures. For patients with three or more LH lesions
satisfying
eligibility criteria, the two LH lesions will be selected based on randomized
selection, and the
biopsied LH lesion is randomly selected from the two selected LH lesions. For
punch biopsies,
the biopsy size may be in the range of 1 mm to 10 mm, 1 mm to 8 mm, or 5 mm to
8 mm in
diameter, and verified during the biopsy procedure to include at least some
subcutaneous tissue.
For needle biopsies, the needle size may be 18 gauge to 25 gauge needle. A
tensioned tissue
treatment device is then applied to the LH lesion that was biopsied. Each
patient is taught the
two locations of the LH lesions and taught not to perform any injections into
the either of the LH
lesions for the duration of the study. The patient is also instructed on how
to change over their
insulin regimen to a rapid-acting insulin analogue. Because of the limited
availability of drug
assays, such as those available for insulin lispro, e.g. HUMALOG (Lilly;
Indianapolis, IN), and
rapid-acting insulin lispro, e.g. LYUMJEV (Lilly; Indianapolis, IN), the rapid-
acting insulin
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selected for the regimen may be selected to be different from that used during
insulin PK-PD
testing, e.g. insulin aspart, e.g. NOVOLOG (Novo Nordisk; Plainsboro, NJ).
The tensioned tissue treatment devices are applied to selected LH lesion for a
time period
in the range of 4 to 12 weeks, or 6 to 8 weeks, or 4 to 6 weeks before
returning for study follow-
up. At the next follow-up visit, insulin sensitivity will be measured by a
hyperinsulinernic
euglycemic clamp (HEC) testing. The blood glucose of each subject will be
adjusted to 100
mg/dL ( 5 mg/dL) prior to the start of the test procedure, using either
glucose or insulin,
without simultaneous infusion. Any insulin infusion is tapered off and stopped
for at least 10
minutes prior to clamp testing. Each subject will undergo six 6-hour HEC
tests, two for each of
the injection sites, with the sequence individually randomized. At the start
of each test, 0.15
units/kg of insulin will be initially injected, into normal adipose tissue,
the untreated LH lesion,
and the LH lesion that was treated with the tensioned tissue treatment device,
as specified by the
randomized sequence. The euglycemic clamp equipment is then used to record
blood glucose
levels every minute during the clamp procedure, and to automatically adjust a
glucose infusion
rate to maintain the blood glucose within the target range. Insulin levels are
measured during the
test, e.g. at 15, 30, 45 60, 80, 100, 120, 150, 180, 210, 240 and 300 minutes
after the insulin
injection into the test site. From the HEC testing, the area-under-the insulin
concentration curve,
the Clliax insulin level and the area-under-the blood glucose infusion rate
curve, and the
intrasubject coefficient of variation for each of these measures may be
calculated for each test
injection into normal adipose tissue, the untreated LH lesion and the treated
LH lesion. It is
hypothesized that the untreated LH lesion will have the lowest AUCINS, Cmax
and AUCGIR, and
the highest corresponding coefficient of variation for each test compared to
normal adipose
tissue and the treated LH lesion site, with the treated LH lesion site showing
an improvement
over the untreated LH lesion site. The change or progression in tissue
stiffness, as measured by a
CUTOMETERO (Courage + Khazaka electronic GmbH; Kohn, DE) and/or the effect
size of the
pharmacokinetic/pharmacodynamics improvements is hypothesized to be at least
10%, 15%,
20% or 25% for the treated LH lesion compared to the untreated LH lesion.
Following
completion of the HEC testing, each subject will resume their usual diabetes
therapy for two
weeks, while continuing to use the CGM and to apply the tensioned tissue
treatment device to
the same LH lesion that was selected for treatment.
Upon the next two week return visit, the LH lesions are re-measured, and last
period of
CGM data will be downloaded and pre-testing labs are obtained. Each subject
will also re-initiate
the use of a shorter acting insulin as before with the HEC testing, in order
to wash-out any
longer-acting insulin used by the subject with their usual diabetes therapy.
The a washout period
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will be at least 12 hours to three days prior to the mixed-meal tolerance
testing (MMTT),
depending on the type of insulin used in their usual diabetes regimen. During
the MMTT, a
rapidly absorbed of 75 g of carbohydrate (56% meal caloric content), 20 g of
fat (33%) and 15.2
g protein (11%) is consumed. The data acquisition for the MMTTs would
otherwise be the same
as for the HEC testing. It is hypothesized that the untreated LH lesion will
again have the lowest
AUCiNs, Cmax and AUCGIR, and the highest corresponding coefficient of
variation for each test
compared to normal adipose tissue and the treated LH lesion site, with the
treated LH lesion site
showing an improvement over the untreated LH lesion site. Following completion
of the
MMTTs, each subject will resume their usual diabetes therapy and cease the use
of the tensioned
tissue treatment. End-of-study labs and physical examination will be
performed. In some
variations of the study, the MMTT is performed once for each test site, but in
other variations of
the study, may be performed twice for each site and the results averaged.
In another study, the effects of applying tensioned tissue treatment on normal
adipose
tissue will be assessed. Eligible participants will include adults aged 18 to
70 years with type 1
diabetes taking insulin by multiple daily injections (at least three
injections daily) for at least two
years. Subjects may or may not be using a continuous glucose monitor but will
be asked to wear
a CGM as part of the study protocol. HbAlc must be in the range of 7.5% to
10.5% at the
screening visit. The initial examination includes a physical examination, lab
tests for
CBC/chemistry blood panels, urinalysis, and HbAl c. A CGM will be applied for
10 to 14 days
to monitor the patients.
At the next visit, the CGM data is downloaded to establish baseline blood
glucose and
insulin use. A tensioned tissue treatment device is then applied to one of two
selected injection
sites that is free of lipohypertrophy. The patient is also instructed on how
to change over their
insulin regimen to a rapid-acting insulin analogue Because of the limited
availability of drug
assays, such as those available for insulin lispro, e.g. HUMALOG (Lilly:
Indianapolis, IN). and
rapid-acting insulin lispro, e.g. LYUMJEV (Lilly; Indianapolis, IN), the rapid-
acting insulin
selected for the regimen may be selected to be different from that used during
insulin PK-PD
testing, e.g. insulin aspart, e.g. NOVOLOG (Novo Nordisk; Plainsboro, NJ).
The tensioned tissue treatment devices are applied to selected injection sites
for a time
period in the range of 4 to 12 weeks, or 6 to 8 weeks, or 4 to 6 weeks before
returning for study
follow-up. At the next follow-up visit, insulin sensitivity will be measured
by a
hyperinsulinemic euglycemic clamp (HEC) testing. The blood glucose of each
subject will be
adjusted to 100 mg/dL ( 5 mg/dL) prior to the start of the test procedure,
using either glucose or
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insulin, without simultaneous infusion. Any insulin infusion is tapered off
and stopped for at
least 10 minutes prior to clamp testing. Each subject will undergo four 6-hour
HEC tests, two
for each injection site, with the sequence individually randomized. At the
start of each test, 0.15
units/kg of insulin will be initially injected, twice into untreated normal
adipose tissue, twice into
the treated injection site, for a total of four tests. The euglycemic clamp
equipment is then used
to record blood glucose levels every minute during the clamp procedure, and to
automatically
adjust a glucose infusion rate to maintain the blood glucose within the target
range. Insulin
levels are measured during the test, e.g. at 15, 30, 45 60, 80, 100, 120, 150,
180, 210, 240 and
300 minutes after the insulin injection into the test site. From the HEC
testing, the area-under-
the insulin concentration curve, the Cmax insulin level and the area-under-the
blood glucose
infusion rate curve, and the intrasubject coefficient of variation for each of
these measures may
be calculated for each test injection into untreated normal adipose tissue,
and the treated injection
site. It is hypothesized that the untreated injection site will have the
lowest AUCiNs, Cinax and
AUCGIR, and the highest corresponding coefficient of variation for each test
compared to the
treated injection site. Following completion of the HEC testing, each subject
will resume their
usual diabetes therapy for two weeks, while continuing to use the CGM and to
apply the
tensioned tissue treatment device to the same injection site that was selected
for treatment with
the tensioned tissue treatment system.
Upon the next two week return visit, injection sites will be re-evaluated, and
last period of
CGM data will be downloaded and pre-testing labs are obtained. Each subject
will also reinitiate
the use of a shorter acting insulin as before with the HEC testing, in order
to wash-out any
longer-acting insulin used by the subject with their usual diabetes therapy.
The washout period
will be at least 12 hours to three days prior to the mixed-meal tolerance
testing (MMTT),
depending on the type of insulin used in their usual diabetes regimen. During
the MMTT, a
rapidly absorbed of 75 g of carbohydrate (56% meal caloric content), 20 g of
fat (33%) and 15.2
g protein (11%) is consumed. The data acquisition for the MMTTs would
otherwise be the same
as for the HEC testing. It is hypothesized that the untreated injection site
will again have the
lowest AUCINS, Cmax and AUCGIR, and the highest corresponding coefficient of
variation for
each test compared to the treated LH lesion site. Following completion of the
MMTTs, each
subject will resume their usual diabetes therapy and cease the use of the
tensioned tissue
treatment. End-of-study labs and physical examination will be performed. In
some variations of
the study, the MMTT is performed once for each test site, but in other
variations of the study,
may be performed twice for each site and the results averaged.
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In variant of the proposed studies above, patients will wear and collecting 14
days of
continuous glucose monitoring data for multiple periods. Using the data, time-
in-range (TIR),
the glucose management index (GMI) and various hyperglycemic measurements will
be assessed
using three different injection sites: normal adipose tissue, a
lipohypertrophy site that is treated
with a tensioned tissue treatment device, and a lipohypertrophy site control
that is not treated
with a tensioned tissue treatment device. Insulin usage during the study
period will also be
tracked. The three sites would be measured, using blinded CGM at the following
time points: 0
to 2 weeks for a baseline, 6 to 8 weeks for the first comparison point and 10
to 12 weeks for the
second comparison point. The order of data gathering is randomized, between an
analysis of
treated and untreated LH lesions, and an analysis between the treated LH
lesion and normal
adipose tissue. The glucose management index for the measurement period will
be calculated by:
GMI(%) = 3.31 + 0.02392 x mean glucose in mg/di
The TIR will be calculated as percentage of the CGM data spent in very low and
low
hypoglycemic states of <54 mg/di and <70 mg/di, in range between 70-180 mg/di,
and in high
and very high hyperglycemic states of > 180 md/d1 and >250 mg/d1. The glycemic
variability
will be calculated using coefficient of variation (CV) and standard deviation
for the measurement
periods. Daily glucose profile graphs with the median glucose value, the
middle 50% value and
the 10% and 90% distributions lines are generated. The LH lesions will be
measured at baseline
and tracked during the study period for size, density and stiffness, as
measured by various
stiffness metrics generated by a CUTOMETERCW. It is hypothesized that
treatment of an LH
lesion with a tensioned tissue treatment device may increase TIR, reduce
measures of GV,
reduce the percentage time spent in hypoglycemia states (alone or combined),
hyperglycemic
states (alone or combined), or total hypoglycemia/hyperglycemia (combined).
While this invention has been particularly shown and described with references
to
embodiments thereof, it will be understood by those skilled in the art that
various changes in
form and details may be made therein without departing from the scope of the
invention. For all
of the embodiments described above, the steps of the methods need not be
performed
sequentially.
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