Note: Descriptions are shown in the official language in which they were submitted.
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CAPPING AND CLEANSING DEVICES FOR
NEEDLEFREE VASCULAR ACCESS CONNECTORS
Technical Field of the Invention
This invention is directed to cleansing devices for cleansing and capping
medical
devices, particularly luer access devices such as needlefree, valved
connectors (NCs), and
methods for making and using such articles.
Background of the Invention
1. Introduction.
The following description includes information that may be useful in
understanding the
present invention. It is not an admission that any such information is prior
art, or relevant, to
the presently claimed inventions, or that any publication specifically or
implicitly referenced is
prior art.
2. Background.
In the medical field, and in particular the area of infusion of fluids or
aspiration of fluids
to or from a patient there remains a need to prevent the transmission of
pathogens into or onto
a patient from a potentially contaminated surface of a medical device such as
a luer access
device, for example, a needlefree, valved connector (NC). Pathogens include
microorganisms
such as bacteria, fungi, and viruses, the transmission of which into a patient
may result in an
infection that could be life-threatening. Specific to healthcare settings, the
term "nosocomial
infection" describes those infections that originate from or occur in a
hospital or hospital-like
setting. In the U.S., nosocomial infections are estimated to occur in at least
5% of all acute care
hospitalizations. The estimated incidence is more than two million cases per
year, resulting in
significant morbidity, mortality, and an expense. Indeed, nosocomial
infections are estimated to
more than double the mortality and morbidity risks of any admitted patient,
and likely result in
about 100,000 deaths a year in the United States alone. Common sites for the
transmission of
contaminating microorganisms into a patient's bloodstream are found on medical
devices such
as luer access devices, vials, needlefree (or needle free) valves, and the
injection ports of vessels,
tubing, and catheters. The incidence of such infections in patients is
increasing, and infection
control practitioners (ICPs) often cite improper cleansing of sites as a major
source of such
infections.
As described above, patient exposure to pathogens and infectious reagents
(e.g.,
pathogenic bacteria, viruses, fungi, etc.) in medical settings (e.g.,
hospitals, out-patient surgery
centers, home-care settings, etc.) is a matter of serious concern. One route
of exposure to such
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reagents is the opening made in skin provided by the bore of needle, cannula,
or other similar
device used to provide access to a patient's vasculature. It is known that
patients whose skin
has been compromised in this way are at increased risk for developing serious
blood stream
infections. In the United States alone, approximately 300,000 blood stream
infections per year
result from the installation and use of peripheral intravenous catheters
(PIVC), and more than
80,000 blood stream infections are associated with the use central venous
catheters (CVC). All
told, in the U.S. approximately 28,000 patients die annually from hospital-
acquired infections
that result from PIVC and CVC use, and many times that number are made
seriously ill but
survive. Costs associated with the care and treatment of patients that develop
infections due to
PIVC and CVC use is estimated to exceed $4 billion annually in the U.S. alone.
In hospital settings today, occupational health and safety regulations
designed reduce
the risk to health care workers from needle stick and similar injuries have
resulted in the
deployment of needlefree medical valves (also referred to herein as
"needlefree connectors" or
"NCs") whenever possible. Currently, more than 1 billion NCs are used annually
in hospitals
throughout the U.S. Needlefree connectors are used primarily in conjunction
with PIVC and CVC
devices and associated IV administration and extension sets, which may contain
from as few as
one to as many as 3, 4, 5, or more NCs. Figure 2A illustrates an example of a
representative NC
in use today.
The widespread use of needlefree connectors in acute medicine has contributed
to a
marked increase in the incidence of hospital-acquired infections (HAls),
particularly blood
stream infections (BSIs). To reduce the risk of infection from a needlefree
connector
contaminated with microorganisms, standard practice today requires that a
nurse or other
healthcare worker clean (or "scrub") the surface of NC by vigorously rubbing
those of its
exterior surfaces in the fluid path with a sterile alcohol swab or wipe
immediately prior to
making a fluid connection to the NC, for example, by attaching a syringe to
the NC's threaded
valve portion to deliver a medication via a PIVC already connected to the
patient Given the
magnitude of the mortality and morbidity associated with HAls, particularly
with regard to
central line-associated blood stream infections (CLABSIs), and the large
number of blood stream
infections that result from PIVC and CVC use (so-called "peripheral line-
associated blood
stream infections (PLABSIs) and central line-associated blood stream
infections (CLABSIs),
respectively), a long-recognized yet significant unmet need exists for
articles or devices that can
be used to reduce or eliminate the risk of initiating an HAI merely by
accessing a patient's
vasculature through a needlefree valve component of a P1VC or CVC inserted
into a blood vessel
of a patient
Traditionally, and as noted above, cleaning, cleansing, or disinfecting a
potentially
contaminated NC surface involved a protocol of alcohol swabbing prior to
making the necessary
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connections to the site. Alcohol swabs are typically small pads of cotton
gauze soaked in
isopropyl alcohol (IPA), packed individually in foil packages to prevent
evaporation of the IPA
from the swab prior to use. Properly used, the package is opened at or near
the site to be
swabbed. With gloved hands, the swab is removed by a nurse or other healthcare
provider and
used to scrub the top and side surfaces of the valve portion of the NC to be
connected. After use,
the swab and foil package are discarded and the cleansed valve portion of the
NC is allowed to
dry, usually 20-30 seconds, immediately prior to making any connection. This
"drying" period is
important because, as the IPA dries, it breaks open the cellular walls of
microorganisms, thereby
killing them.
Unfortunately, because of increased duties and responsibilities, shrinking
nursing staffs,
and inadequate training, alcohol swabbing (or scrubbing) is often not
performed or is poorly
executed. A poorly swabbed site can carry microorganisms that, if allowed to
enter a patient's
body, can cause serious, and potentially life-threatening, infection. In
addition, supervisory
oversight is nearly impossible, because unless a supervisor actually observes
swabbing as it is
performed, the supervisor cannot know whether or not the scrubbing procedure
was done
properly or performed at all. Indeed, reported compliance with such "scrub the
hub" protocols
has been as low as 10%. Further, without at least a sufficient microscopic
examination for
microbial residue (e.g., biofilm), there may be no evidence of "scrubbing the
hub" being
performed.
Thus, a significant need still exists for devices and techniques cleanse sites
on medical
devices prior to their use with or connection to patients, and which eliminate
technique-related
and training issues and provide an unequivocal indicator that a site is clean
prior to accessing a
patient's vascular system.
3. Definitions.
Before describing the instant invention in detail, several terms used in the
context of the
present invention will be defined. In addition to these terms, others are
defined elsewhere in
the specification, as necessary. Unless otherwise expressly defined herein.,
terms of art used in
this specification will have their art-recognized meanings.
As used herein, the singular forms "a", "an", and "the" include plural
references unless
the context clearly dictates otherwise.
As used herein, the term "about" refers to approximately a +/-10% variation
from the stated value. It is to be understood that such a variation is always
included in any
given value provided herein, whether or not it is specifically referred to.
A "patentable" composition, process, machine, or article of manufacture
according to the
invention means that the subject matter at issue satisfies all statutory
requirements for
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patentability at the time the analysis is performed. For example, with regard
to novelty, non-
obviousness, or the like, if later investigation reveals that one or more
claims encompass one or
more embodiments that would negate novelty, non-obviousness, etc., the
claim(s), being limited
by definition to "patentable" embodiments, specifically excludes the
unpatentable
embodiment(s). Also, the claims appended hereto are to be interpreted both to
provide the
broadest reasonable scope, as well as to preserve their validity. Furthermore,
if one or more of
the statutory requirements for patentability are amended or if the standards
change for
assessing whether a particular statutory requirement for patentability is
satisfied from the time
this application is filed or issues as a patent to a time the validity of one
or more of the
appended claims is questioned, the claims are to be interpreted in a way that
(1) preserves their
validity and (2) provides the broadest reasonable interpretation under the
circumstances.
A "plurality" means more than one.
The term "species", when used in the context of describing a particular
compound or
molecule species, refers to a population of chemically indistinct molecules.
Summary of the Inventioq
The object of the invention is to address these long-standing but still unmet
needs. This
invention addresses these needs by providing patentable, single-use cleansing
(disinfecting)
and capping devices or articles that can be used to effectively and
efficiently cleanse/disinfect
and cap., and preferably sterilize, exposed surfaces of medical articles such
as luer access
devices, particularly needlefree connectors., particularly the accessible
surface(s) of the
threaded valve portions of needlefree connectors, particularly those surfaces
(valve surfaces,
threads, etc.) that may become contaminated with pathogens or other infectious
reagents and
which form part of the fluid communication pathway between an external fluid
source (e.g., a
medicine filled syringe with a male luer fitting, an IV bag, etc.) and a
patient's blood stream. In
the context of the invention, "cleanse" encompasses cleaning, disinfecting,
sanitizing, and/or
sterilizing, whereas "capping" refers to using a device, i.e., a "cap", to
cover a surface, or set of
surfaces, of an NC so as to limit or prevent exposure of such surface(s) to
the environment (e.g.,
the air circulating in a hospital's intensive care unit, the microbiome
resident on a patient's skin,
clothing, bedding, unclean fingers, etc.) for a period longer than necessary
to cleanse the desired
surface(s) of a needlefree connector.
Thus, in one aspect, the invention provides capping and disinfecting devices
for medical
devices such as luer access devices, including needlefree, valved vascular
access connectors
(NCs). In general, such devices include an inner housing configured to allow
the device to be
screwed onto and unscrewed from the threaded valve portion of an NC, an outer
housing that
retains the inner housing but which a user can, when desired, rotate
independently of the inner
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housing to provide scrubbing or disinfecting action, and a compressible
cleansing matrix
preferably impregnated with a disinfectant, for example, a 70% IPA solution.
The device also
preferably includes an easily removable seal to maintain sterility and prevent
loss of the
disinfectant after the device is assembled until such time as it is used in
the field to outer
housing and cleanse an NC.
The devices of the invention include an inner housing. In some preferred
embodiments,
the inner housing is comprised of a sidewall that bounds a central, interior
(preferably
cylindrical) bore that spans between oppositely disposed first and second (or
upper and lower,
respectively) openings. In many of these embodiments, the first (upper)
opening is sized to
allow the compressible cleansing matrix resident at least in part in a matrix
well or otherwise
attached to the inner surface of the outer housing to protrude into and
through the opening into
the inner housing's central bore so that the compressible cleansing matrix can
engage one or
more exterior surfaces of a needlefree connector when the capping and cleaning
device is
secured to the connector. The second (lower) opening of the inner housing is
sized to allow the
threaded valve portion of a needless connector to be capped and/or cleansed to
be inserted into
capping and cleansing device of the invention. The interior wall of the inner
housing's central
bore includes one or more thread-engaging tabs (or threads), preferably two
(or more)
oppositely disposed (or otherwise spaced) thread-engaging tabs, preferably
near the lower
opening. The thread-engaging tab(s)(or threads) is(are) configured to engage a
complementary
threaded region on the exterior surface of, for example, a needlefree
connector such that the
capping and cleansing device can, via association of the thread tabs or
threads on the interior of
the inner housing's central bore with complementary threads on the threaded
portion of a
needlefree connector, be securely threaded onto (or otherwise removably
connected with) the
targeted threaded portion of a needlefree connector for capping and, if
desired, cleansing.
In some preferred embodiments, the outer surface of the inner housing includes
an
outer housing-retaining region that includes one or more structures, for
example, a
circumferential flange (or spaced flange elements), that allow the inner
housing to be retained
in the outer housing via association with one or more complementary structures
(e.g., a
circumferential flange (or spaced flange elements) or other suitable engaging
elements) on the
inner surface of the sidewall of the outer housing. Preferably, such
configurations of
complementary retaining elements also allow for smooth, low friction movement
(i.e., rotation)
of the inner and outer housings in relation to each other during certain
operations, for example,
during a disinfection procedure of a needlefree connector. In some of these
embodiments, the
retaining element(s) of the inner housing can mechanically engage an adjacent
region on the
inner surface of the sidewall of the outer housing, for example, when a user
squeezes or
otherwise applies sufficient force to the outer housing to deform it so as to
allow engaging
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regions on the inner surface of the outer housing to engage corresponding
engaging regions on
the exterior surface of the inner housing so as to allow the inner and outer
housings to rotate in
unison (as would occur, for example, when a user attaches or removes a device
from an NC). In
some of these embodiments, the retaining element(s) of the inner housing can
also serve as
engaging elements with complementary regions, features, or structures on the
inner surface of
the sidewall of the outer housing adjacent or otherwise in close proximity
thereto. In other
embodiments, the outer surface of the inner housing further includes one or
more outer housing
engaging elements or regions designed to associate with one or more inner
housing engaging
elements or regions disposed on the interior or inner surface of the outer
housing. Examples of
such elements include, for example, a circumferential band of spaced teeth or
teeth-like
elements protruding from the exterior surface of the inner housing and
positioned below the
outer housing-retaining region (e.g., a circumferential flange), which teeth
(or other suitable
engaging structures) can be engaged by complementary structures arrayed on the
interior
surface of the outer housing when the housings are assembled into a functional
subassembly.
In other preferred embodiments, the upper exterior surface of the inner
housing
includes an outer housing-engaging region that includes one or more structures
that allow the
inner housing to mechanically engage complementary structures (e.g., pawls or
other suitable
engaging elements) on the inner surface of the top of the outer housing so
that when the
complementary engaging elements of the outer housing and inner housing are
brought into
close proximity the engaging elements of the outer housing and inner housing
engage, allowing
the outer housing and inner housing to rotate in unison. Certain preferred
embodiments of
outer housing-engaging structures include spaced teeth (or other suitable
engaging elements)
arrayed on the top or upper surface of the inner housing's preferably
cylindrical sidewall. As
will be appreciated, when such inner and outer housing engaging elements are
unmated or
disengaged, a user can rotate or spin the outer housing in relation to the
inner housing, as is, for
example, done during a cleansing or disinfecting operation of the needlefree
connector to which
the device of the invention is attached. Thus, when the capping and cleansing
device is secured
to a needlefree connector, when such engaging elements are not functionally
associated (or
mated or otherwise engaged), a user can rotate the outer housing (and
compressible cleansing
matrix) in relation to the inner housing and connected needlefree connector.
On the other hand,
when the complementary elements on the inner surface of the top of the outer
housing and the
upper surface of the top of the inner housing are engaged (in whole or even
partially), such as
when a user applies downward pressure to the device to place it on or remove
it from a
needlefree connector, the inner and outer housings rotate together, allowing,
for example, the
capping and cleansing device to be attached to or removed from the NC.
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In some preferred embodiments, the inner housing also includes an NC sealing
member
configured to provide a fluid tight seal between the capping and cleansing
device of the
invention and a needlefree connector connected thereto. In some embodiments
the NC sealing
member is an 0-ring (or comparable seal) preferably disposed in a channel
formed in the inner
surface of the wall of the inner housing proximate to the second (lower)
opening, typically
below the thread-engaging tab(s)(or threads).
The devices of the invention also include an outer housing adapted or
configured to
retain the inner housing therein such that, when the device is attached to a
needlefree
connector, under certain conditions the outer housing can rotate (preferably
about its central
axis) in relation to the inner housing. Any suitable configuration of
complementary mechanical
or structural features or elements on facing or opposing surfaces can be used
to provide
retention of the inner housing inside the outer housing's main cavity and to
allow for
engagement and disengagement of the outer housing from the inner housing in
order to allow
the outer housing to be rotated in relation to the inner housing when the
device is attached to a
needlefree connector and a user desires to cleanse the corresponding
surface(s) of the NC using
the capping and cleansing device of the invention.
In some embodiments, when the device of the invention is attached to a
needlefree
connector, the inner and outer housings adopt a disengaged, neutral, or
rotating configuration
relative to each other such that a user can rotate the outer housing in
relation to the inner
housing to perform a cleansing operation on the valve portion of the NC to
which the device is
attached. Such a disengaged, neutral, or rotating configuration can be
achieved by any suitable
approach, including by providing complementary engaging elements or structures
on adjacent
surfaces of the inner and outer housings that under certain conditions, for
example, when the
outer housing is pulled up, pushed down, or squeezed by a user in relation to
the inner housing,
engage each other; otherwise the engaging elements remain disengaged, which
allows rotation
of the outer housing in relation to the inner housing when the device is
secured to an NC.
Features that allow transitioning between engaged and disengaged positions
include springs or
biasing or resilient elements or materials. In other embodiments, when the
device is attached to
a needlefree connector, the inner and outer housings adopt an engaged
configuration relative to
each other such that they rotate in unison unless a user applies sufficient
force to the outer
housing to cause the engaging elements to disengage and thus allow the outer
housing to be
rotated independently of the inner housing.
The outer housing includes a cylindrical cavity designed to receive and retain
the inner
housing using one or more features or elements that allow the outer housing to
be rotated in
relation to the inner housing if and when desired. The cavity is formed by a
curved outer
sidewall that in some embodiments is joined to a top portion of the housing
about its periphery
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and which also preferably has a concentric central matrix well or matrix
attachment region to or
with which the compressible cleansing matrix is attached or otherwise
associated, although in
some embodiments some degree of eccentricity between the matrix well and
central rotational
axis of the outer housing may be desired. In some embodiments, the outer
housing is formed by
a sidewall that is tapered and/or has one or more steps.
In some preferred embodiments, the inner surface of the top of the outer
housing
includes one or more inner housing engaging elements or structures (e.g.,
teeth) designed to
releasably engage complementary structures in the outer housing-engaging
region on the top of
the inner housing. Engagement of the outer housing's inner housing engaging
structure(s) with
those in the outer housing-engaging region of the inner housing allow a user
to rotate the outer
housing and inner housing in unison, for example, as a capping and cleansing
device's inner
housing is screwed onto the threaded portion of a needlefree connector to be
cleansed and/or
capped. Once the device is releasably secured to a needlefree connector via
the inner housing),
the outer housing's inner housing engaging elements or structure(s) can be (or
are) disengaged
from the outer housing-engaging elements of the inner housing, for example, by
the biasing
action or resilience of a the compressible cleansing matrix, thereby allowing
a user to rotate the
outer housing about its central axis in relation to the inner housing. A
representative example
of such engaging structures is shown in published US patent application
publication no.
2018/0304067, although features such as an inner housing having an opening in
its top to allow
a compressible cleansing matrix attached to the inner surface of the top of
the outer housing to
extend into the bore of the inner housing so that it can contact surfaces of a
needlefree
connector upon connection of the former to the latter are also envisioned.
In some of these embodiments, the outer housing may include one or more vents
to
allow fluid and/or air from inside the device to escape as the capping and
cleansing device is
secured to a needlefree connector, while in other embodiments, no vent(s)
is(are) provided. In
embodiments with one or more vents, a membrane, filter, or other permeable or
semi-
permeable barrier may be employed to allow a unidirectional or bidirectional
flow of air, gas, or
vapor through the vent(s) but prevent the movement of microorganisms (e.g.,
bacteria, fungi,
viruses, etc.) into the capping and cleansing device of the invention.
In certain preferred embodiments, the outer surface of the outer housing of a
capping
and cleansing device according to the invention includes one or more grip-
enhancing structures
(e.g., a plurality of vertical ridges) or coatings. Such grip-enhancing
structures or coatings
facilitate a user's grasp of the housing of a capping and cleansing device
between her/his
fingers, which can be helpful not only during insertion and removal of a
needlefree connector
from the capping cleansing device, but also during the cleansing process,
where the user rotates
the outer housing in relation to the inner housing in order to scrub and
thereby clean or cleanse
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the surface(s) of the inserted needlefree connector with the compressible
cleansing matrix of
the device.
In some preferred embodiments, the devices of the invention include one or
more
elements or features arrayed on facing surfaces of the inner and outer
housings that allow a
user to sense that the outer housing is rotating in relation to the inner
housing in order to
provide cleansing action on the valve surface of the NC to which the device is
attached. Such
sensory feedback can include one or more of auditory, tactile, and/or visual
stimuli generated
from the device by rotation of the outer housing in relation to the inner
housing.
In the devices of the invention, the inner and outer housings are manufactured
separately by any suitable process, for example, 3D-printing, injection
molding, etc., and then
assembled into a two-part subassembly in which the inner housing is retained
within the main
cavity of the outer housing by one or more complementary retaining elements,
features, or
structures on each housing. The inner and outer housings also include
complementary
mechanical or structural engaging elements, features, or structures on one or
more interfacing
surfaces that can be engaged and disengaged so as to allow the inner and outer
housings to
rotate together or to allow the outer housing to rotate independently of the
inner housing. In
this way, the inner and outer housings can be associated such that they can
rotate in unison,
allowing a user to thread (or screw) the device onto or remove (unscrew) it
from the threaded
valve portion of an NC if and when desired, while also making it possible for
a user to rotate the
outer housing in relation to the inner housing, thereby allowing the
compressible cleansing
matrix to effectively scrub or cleanse the region(s) of a threaded valve
portion of an NC to which
it is attached. In certain preferred embodiments, the inner and outer housings
further include
complementary mechanical or structural housing sealing elements, features, or
structures on
one or more interfacing surfaces that allow formation of seal between adjacent
surfaces of the
inner and outer housings, which seal is preferably substantially fluid tight
but does not
substantially hinder or inhibit rotation of the outer housing in relation to
the inner housing
during performance of a cleansing procedure or process by a user. In sonic
embodiments, the
inner housing may also include a seal that interacts with the needlefree
connector to form an
additional or alternate seal.
A capping and cleansing device of the invention also includes a compressible
cleansing
matrix disposed therein. In most embodiments, the compressible cleansing
matrix is disposed
in a matrix well or the like in the interior of the outer housing, although
any suitable retaining
configuration can be employed that allows the compressible cleansing matrix to
rotate in
conjunction with rotation of the outer housing so as to provide the capability
of using the
compressible cleansing matrix to scrub or otherwise clean, cleanse, or
disinfect the surface(s) of
the valve region of a needlefree connector. As will be appreciated., the
compressible cleansing
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matrix is positioned to contact one or more exterior surface(s) of an NC
connected to the
capping and cleansing device. The compressible cleansing matrix, for example,
an open-cell or
felted foam, is preferably retained in the matrix well by one or more matrix
retaining elements,
which element(s) assist in retention of the compressible cleansing matrix in
the matrix well in
addition to transmission of rotational forces from the outer housing to the
compressible
cleansing matrix as occurs during a procedure to disinfect or cleanse a
needlefree connector. As
will be appreciated, during such rotation (of the outer housing and
compressible cleansing
matrix), the compressible cleansing matrix also rotates in relation to the
inner housing when
the outer housing is rotated during a procedure to disinfect or cleanse a
needlefree connector.
The compressible cleansing matrix attached to or otherwise associated with the
outer housing
can be axially compressed (i.e., compressed along the central axis of the
outer housing's matrix
well) upon insertion of a needlefree connector into such a capping and
cleansing device.
Because the needlefree connector surface(s) to be cleansed may be contaminated
with
microorganisms that form a biofilm (i.e., a matrix of microorganisms and
extracellular material
attached to a surface, which enables the microorganisms, typically bacteria
and/or fungi, to
adhere to a surface and carry out certain biochemical processes), the
compressible cleansing
matrix also preferably has sufficient mechanical integrity when compressed and
rotated to
allow it to disrupt any biofilm that may be present on the surface of the
needlefree connector, as
can occur by rotating, twisting, or otherwise moving the then-compressed
cleansing matrix in
relation to the needlefree connector, for example, by rotating the outer
housing (to which the
compressible cleansing matrix is attached) in relation to the inner housing of
the capping and
cleansing device and the needlefree connector to which inner housing is
releasably attached.
The resulting friction between the compressed cleansing matrix and surface of
the needlefree
connector disrupts the biofilm, thereby cleansing, and preferably sterilizing,
the needlefree
connector. Leaving the capping and cleansing device secured to (i.e., capping)
the needlefree
connector after such a cleansing operation will limit, and preferably
preclude, biofilm regrowth
and/or the microbial recolonization of cleansed surfaces (which remain in
contact with the
compressible cleansing matrix).
In preferred embodiments, the compressible cleansing matrix includes one or
more
cleansing reagent species dispersed therein, preferably at the time the device
is manufactured,
although in some embodiments, the cleansing reagent may be dispersed into the
matrix just
prior to the matrix coming into contact with a needlefree connector. In
embodiments of the
latter sort, the cleansing reagent is preferably housed in the housing of the
capping and
cleansing device in a reservoir configured to be ruptured just prior to
performance of a
cleansing operation. In some embodiments, the capping and cleansing device of
the invention
will include a valve or opening to allow liquid in the cleansing reagent to
evaporate.
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In some preferred embodiments, the compressible cleansing matrix includes two
or
more components. in some of such embodiments, one component of the matrix is
attached to
the inner surface of the outer housing and another component is secured to the
inner surface of
the wall forming the inner housing, preferably between protruding threaded
regions adapted to
engage complementary threads on a needlefree connector. If present, the
component of the
compressible cleansing matrix secured to the inner surface of the inner
housing wall is
preferably configured to radially compress upon association with a needlefree
connector to be
capped and cleansed.
In preferred embodiments, the capping and cleansing devices of the invention
include a
removable lid or seal attached to the outer housing to seal the device, thus
separating the
interior spaces and structures of the inner and outer housings from the
external environment.
Such a lid or seal prevents exposure of the device's interior, including the
inner housing and
compressible cleansing matrix, to the environment until the removable
(preferably, peelable)
lid or seal is removed, typically by a healthcare worker just prior to her/his
use of the capping
and cleansing device to clean, cleanse, or disinfect a needlefree connector to
which a fluid
connection is to be made. In preferred embodiments, such cleansing
substantially disrupts any
microbial contamination, for example, microbial biofilm or other microbial
contamination that
may exist on surfaces contacted by the compressible cleansing matrix. If
desired, the capping
and cleansing device can be left in place (typically after cleansing the
needlefree connector
attached thereto) in order to cap the needlefree connector until it is further
accessed, thereby
minimizing exposure of capped exterior surfaces of the NC to potential
pathogen contamination
(and biofilm formation) from the surrounding environment Lids or seals are
typically installed
during manufacture of a capping and cleansing device of the invention. In
those embodiments
where the capping and cleansing devices are sterilized during manufacture
(e.g., by irradiation,
exposure to ethylene oxide, etc.), lids or seals are preferably applied prior
to packaging and
sterilization.
In some preferred embodiments, the devices of the invention are sealed
individually,
while in other embodiments, 2-20 or more devices are sealed onto a single
piece of lidding or
sealing stock, after which they may be separated into individual sealed
products or maintained
in strip form, as a strip format having multiple devices all sealed to a
single strip is a convenient
format for use in healthcare environments, where such strips can be hung, for
example, from an
IV pole at a patient's bedside. After sealing and packaging, the devices of
the invention are
sterilized using any suitable sterilization method (e.g., gamma or e-beam
irradiation, treatment
with ethylene oxide, etc.) compatible with the materials used to manufacture
the particular
device(s) of the invention.
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Other aspects of the invention concern methods of cleansing and/or capping
needlefree
connectors using a capping and cleansing device according to the invention.
Such methods
typically involve disengaging the engaging elements of the outer housing and
inner housing
after it has been connected to a needlefree connector, thus allowing a user to
rotate or spin the
outer housing in relation to the inner housing and needlefree connector to
which the device of
the invention is secured. Such disengagement does not impair contact between
the device's
compressible cleansing matrix and the associated surface(s) of the needlefree
connector.
Spinning or rotation of the outer housing in relation to the inner housing,
and the associated
surface(s) of the needlefree connector, allow those surfaces to be scrubbed,
thereby cleansing
them. Preferably, such cleansing methods provide for the disruption of any
biofilm present on
the surface(s) of the needlefree connector associated the capping and
cleansing device. And in
those embodiments where the compressible cleansing matrix contains one or more
antimicrobial reagents, microbes and pathogens present in such biofilm and/or
on such
surface(s) are preferably destroyed or rendered nonviable.
Features and advantages of the invention will be apparent from the following
detailed
description, and appended claims.
Brief Description of the Drawings
These and other aspects will now be described in detail with reference to the
following
drawings. Unless otherwise indicated, it is understood that the drawings are
not to scale, as
they are intended merely to facilitate understanding of the invention as
opposed to specific
dimensions, etc. In the drawings, like numbers in two or more drawings
represent like
elements.
Figure 1 shows several drawings ((a)-(g)) of a representative capping and
cleansing
device of the invention, its constituent parts (views (b)-(g)), and the device
associated with a
needlefree connector (view (a)).
Figure 2 shows an exploded view (a) of a representative capping and cleansing
device of
the invention and a needlefree connector and several cross-sectional views
((b)-(d)) of a sealed
representative capping and cleansing device of the invention (view (b)) and
such a capping and
cleansing device capping a needlefree connector (views (c) and (d)).
Figure 3 shows six different views of a representative capping and cleansing
device of
the invention. Views (a)-(c) show the device in a static position, where the
cap and resilient
inner body are engaged such that the cap, and hence the compressible cleansing
matrix
associated therewith, cannot rotate in relation to the device's resilient
inner body. Views (d)-(f)
show the same representative device with the cap and resilient inner body in
movable relation
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such that the cap (and the compressible cleansing matrix associated therewith)
can be rotated
in relation to the device's resilient inner body.
Figure 4 shows views of the cap portion of a representative capping and
cleansing
device of the invention. View (a) shows a top view of the cap portion. View
(b) shows a side
view of the cap portion. View (c) shows a bottom view of the cap portion. View
(d) shows a
cross-sectional view of the cap portion. Representative measurements of this
particular
embodiment are shown on views (b) and (d).
Figure 5 shows seven different views ((a)-(g)) of the resilient inner body
portion of a
representative capping and cleansing device of the invention. Representative
measurements of
this particular embodiment are shown on several of the views.
Figure 6 shows five different views ((a)-(e)), three of which show a
compressible
cleansing matrix portion of a representative capping and cleansing device of
the invention.
Views (a)-(c) show top, side, and bottom views of this particular compressible
cleansing matrix.
Views (d) and (e) show bottom and side views of a seal portion of a
representative capping and
cleansing device of the invention.
Figure 7 shows five different views of another representative capping and
cleansing
device of the invention. Fig. 7A shows an exploded perspective view of the
device (outer
housing, compressible cleansing matrix, and inner housing) and an NC to which
the device is to
be connected (see Figs. 7B, 7E). Fig. 7B shows a perspective view of the
assembled device
depicted in Fig. 7A secured to the threaded region of the valve portion of the
NC depicted in Fig.
7A. Fig. 7C shows an exploded cross-section view of the components depicted in
Fig. 7Aõ while
in Fig. 71), the cross section view shows the components of the device of the
invention (outer
housing, compressible cleansing matrix, and inner housing) assembled into a
functional capping
and cleansing device ready for attachment to the threaded region of the valve
portion of the NC
depicted in Fig. 7A. Fig. 7E is a cross section showing the capping and
cleansing device of the
invention screwed onto the NC, which results compression of the compressible
matrix against
the NC's valve surface.
Figure 8 shows five different views of another representative capping and
cleansing
device of the invention. Fig. 8A shows an exploded perspective view of the
device (outer
housing. compressible cleansing matrix, and inner housing) and an NC to which
the device is to
be connected (see Figs. 8B, 8E). Fig. 8B shows a perspective view of the
assembled device
depicted in Fig. 8A secured to the threaded region of the valve portion of the
NC depicted in Fig.
8A Fig. 8C shows an exploded cross-section view of the components depicted in
Fig. 8A, while
in Fig. 81), the cross section view shows the components of the device of the
invention (outer
housing, compressible cleansing matrix, and inner housing) assembled into a
functional capping
and cleansing device ready for attachment to the threaded region of the valve
portion of the NC
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depicted in Fig. 8A. Fig. 8E is a cross section showing the capping and
cleansing device of the
invention screwed onto the NC, which results compression of the compressible
matrix against
the NC's valve surface.
Figure 9 shows five different views of another representative capping and
cleansing
device of the invention, with Fig. 9A showing a perspective view of the device
secured to the
threaded region of the valve portion of an NC. Figs. 913 and 9C each show an
exploded cross-
section view of the device/NC assembly shown in Fig. 9A, the difference being
that the view
depicted in Fig. 9C is slightly rotated about the central axis of the
device/NC assembly as
compared to the view depicted in Fig. 9B. Fig. 9D shows an exploded
perspective view of the
device (outer housing, compressible cleansing matrix, and inner housing)
depicted in Figs. 9A-
9C. Fig. 9E shows a side cross-section and a bottom view of the device
depicted in Figs. 9A-9D.
Figure 10 shows three different cut-away views of another representative
capping and
cleansing device of the invention. Figs. 1013 and 10C show the device secured
to the threaded
region of the valve portion of an NC, while Fig. 10A shows the device
disconnected from the NC.
Fig. 1.0B shows the outer housing of the device in a neutral position (the
engaging elements of
the inner and outer housings are not engaged), from which a user could rotate
the outer housing
(and compressible cleansing matrix) in relation to the inner housing and NC,
to which the inner
housing is secured. As will be appreciated, the compressible matrix can serve
as a spring that in
the absence of a sufficient counteracting downward force, pushes the outer
housing up in
relation to the inner housing, allowing a user to rotate the outer housing
(and compressible
cleansing matrix) in relation to the inner housing and NC is and when desired.
Absent such
rotation, while connected to the NC the capping and cleansing device of the
invention serves as a
cap to protect the threaded valve region of the NC from environmental
contamination, including
microbial contamination. Fig. 10C depicts the device when the engaging
elements of the inner
and outer housings are engaged, allowing the device to be screwed onto or off
of the NC.
The details of one or more embodiments are set forth in the accompanying
drawings
and the description below. Other features and advantages will be apparent from
the description
and drawings, and from the claims.
Detailed Description
In the following detailed description, reference is made to the accompanying
figures
(Figures 1-10), which form a part hereof. In the figures, similar symbols
typically identify
similar components, unless context dictates otherwise. The illustrative
embodiments described
in the detailed description, figures, and claims are not meant to be limiting.
Other embodiments
may be utilized, and other changes may be made, without departing from the
spirit or scope of
the subject matter presented here.
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This invention concerns patentable single-use capping and cleansing devices
that can be
used to effectively and efficiently clean, disinfect, and preferably
sterilize, exposed surfaces of
needlefree connectors, particularly those of luer access devices such as
needlefree medical
valves that at times become part of a fluid communication pathway for
introduction of fluids
(e.g., IV fluids, blood, plasma, medicines, etc.) into a patient, as these
surfaces are at risk for
contamination with pathogens and infectious reagents such as bacteria.,
fungi., and viruses.
"Single-use" (or "single purpose") refers to an article or device suitable for
one use or purpose
only, as distinguished from "dual" or "multiple" use or purpose devices. Thus,
in the context of
the invention, a "single-use" capping and cleansing device is one that is
useful for cleansing, for
example, a needlefree medical valve. After the cleansing operation, the device
may, if desired,
be left in place on the needlefree connector until a subsequent fluid
connection is made in order
to prevent recontamination of the connector's cleansed surface(s), as would
occur if the capping
and cleansing device of the invention was removed immediately following
"scrubbing" of the
connector without a fluid connection then being made. After removal., the
device of the
invention is preferably discarded. Prior to removal, however, the capping and
cleansing device
can again be used to cleanse the capped surface(s) of the needlefree
connector.
In general, a capping and cleansing device of the invention include an inner
housing
configured to allow the device to be screwed onto and unscrewed from the
threaded valve
portion of an NC, an outer housing that retains the inner housing but which a
user can, when
desired, rotate independently of the inner housing to provide scrubbing or
disinfecting action,
and a compressible cleansing matrix preferably impregnated with a
disinfectant, for example, a
70% IPA solution. The device also preferably includes an easily removable seal
to maintain
sterility and prevent loss of the disinfectant after the device is assembled
until such time as it is
used in the field to outer housing and cleanse an NC.
In general, such devices include an inner housing configured to allow the
device to be
screwed onto and unscrewed from the threaded valve portion of an NC, an outer
housing that
retains the inner housing but which a user can, when desired, rotate
independently of the inner
housing to provide scrubbing or disinfecting action., and a compressible
cleansing matrix
preferably impregnated with a disinfectant, for example, a 70% IPA solution.
The device also
preferably includes an easily removable seal to maintain sterility and prevent
loss of the
disinfectant after the device is assembled until such time as it is used in
the field to outer
housing and cleanse an NC.
The devices of the invention include an inner housing. In some preferred
embodiments,
the inner housing is comprised of a sidewall that bounds a central, interior
(preferably
cylindrical) bore that spans between oppositely disposed first and second (or
upper and lower,
respectively) openings. In many of these embodiments, the first (upper)
opening is sized to
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allow the compressible cleansing matrix resident at least in part in a matrix
well or otherwise
attached to the inner surface of the outer housing to protrude into and
through the opening into
the inner housing's central bore so that the compressible cleansing matrix can
engage one or
more exterior surfaces of a needlefree connector when the capping and cleaning
device is
secured to the connector. The second (lower) opening of the inner housing is
sized to allow the
threaded valve portion of a needless connector to be capped and/or cleansed to
be inserted into
capping and cleansing device of the invention. The interior wall of the inner
housing's central
bore includes one or more thread-engaging tabs (or threads), preferably two
(or more)
oppositely disposed (or otherwise spaced) thread-engaging tabs, preferably
near the lower
opening. The thread-engaging tab(s)(or threads) is(are) configured to engage a
complementary
threaded region on the exterior surface of, for example, a needlefree
connector such that the
capping and cleansing device can, via association of the thread tabs or
threads on the interior of
the inner housing's central bore with complementary threads on the threaded
portion of a
needlefree connector, be securely threaded onto (or otherwise removably
connected with) the
targeted threaded portion of a needlefree connector for capping and, if
desired, cleansing.
In some preferred embodiments, the outer surface of the inner housing includes
an
outer housing-retaining region that includes one or more structures, for
example, a
circumferential flange (or spaced flange elements), that allow the inner
housing to be retained
in the outer housing via association with one or more complementary structures
(e.g., a
circumferential flange (or spaced flange elements) or other suitable engaging
elements) on the
inner surface of the sidewall of the outer housing. Preferably, such
configurations of
complementary retaining elements also allow for smooth, low friction movement
(i.e... rotation)
of the inner and outer housings in relation to each other during certain
operations, for example,
during a disinfection procedure of a needlefree connector. In some of these
embodiments, the
retaining element(s) of the inner housing can mechanically engage an adjacent
region on the
inner surface of the sidewall of the outer housing, for example, when a user
squeezes or
otherwise applies sufficient force to the outer housing to deform it so as to
allow engaging
regions on the inner surface of the outer housing to engage corresponding
engaging regions on
the exterior surface of the inner housing so as to allow the inner and outer
housings to rotate in
unison (as would occur, for example, when a user attaches or removes a device
from an NC). In
some of these embodiments, the retaining element(s) of the inner housing can
also serve as
engaging elements with complementary regions, features, or structures on the
inner surface of
the sidewall of the outer housing adjacent or otherwise in close proximity
thereto. In other
embodiments, the outer surface of the inner housing further includes one or
more outer housing
engaging elements or regions designed to associate with one or more inner
housing engaging
elements or regions disposed on the interior or inner surface of the outer
housing. Examples of
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such elements include, for example, a circumferential band of spaced teeth or
teeth-like
elements protruding from the exterior surface of the inner housing and
positioned below the
outer housing-retaining region (e.g., a circumferential flange), which teeth
(or other suitable
engaging structures) can be engaged by complementary structures arrayed on the
interior
surface of the outer housing when the housings are assembled into a functional
subassembly.
In other preferred embodiments, the upper exterior surface of the inner
housing
includes an outer housing-engaging region that includes one or more structures
that allow the
inner housing to mechanically engage complementary structures (e.g., pawls or
other suitable
engaging elements) on the inner surface of the top of the outer housing so
that when the
complementary engaging elements of the outer housing and inner housing are
brought into
close proximity the engaging elements of the outer housing and inner housing
engage, allowing
the outer housing and inner housing to rotate in unison. Certain preferred
embodiments of
outer housing-engaging structures include spaced teeth (or other suitable
engaging elements)
arrayed on the top or upper surface of the inner housing's preferably
cylindrical sidewall. As
will be appreciated, when such inner and outer housing engaging elements are
unmated or
disengaged, a user can rotate or spin the outer housing in relation to the
inner housing, as is, for
example, done during a cleansing or disinfecting operation of the needlefree
connector to which
the device of the invention is attached. Thus, when the capping and cleansing
device is secured
to a needlefree connector, when such engaging elements are not functionally
associated (or
mated or otherwise engaged), a user can rotate the outer housing (and
compressible cleansing
matrix) in relation to the inner housing and connected needlefree connector.
On the other hand,
when the complementary elements on the inner surface of the top of the outer
housing and the
upper surface of the top of the inner housing are engaged (in whole or even
partially), such as
when a user applies downward pressure to the device to place it on or remove
it from a
needlefree connector, the inner and outer housings rotate together, allowing,
for example, the
capping and cleansing device to be attached to or removed from the NC.
In some preferred embodiments, the inner housing also includes an NC sealing
member
configured to provide a fluid tight seal between the capping and cleansing
device of the
invention and a needlefree connector connected thereto. In some embodiments
the NC sealing
member is an 0-ring (or comparable seal) preferably disposed in a channel
formed in the inner
surface of the wall of the inner housing proximate to the second (lower)
opening, typically
below the thread-engaging tab(s)(or threads).
The devices of the invention also include an outer housing adapted or
configured to
retain the inner housing therein such that, when the device is attached to a
needlefree
connector, under certain conditions the outer housing can rotate (preferably
about its central
axis) in relation to the inner housing. Any suitable configuration of
complementary mechanical
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or structural features or elements on facing or opposing surfaces can be used
to provide
retention of the inner housing inside the outer housing's main cavity and to
allow for
engagement and disengagement of the outer housing from the inner housing in
order to allow
the outer housing to be rotated in relation to the inner housing when the
device is attached to a
needlefree connector and a user desires to cleanse the corresponding
surface(s) of the NC using
the capping and cleansing device of the invention.
In some embodiments, when the device of the invention is attached to a
needlefree
connector, the inner and outer housings adopt a disengaged, neutral, or
rotating configuration
relative to each other such that a user can rotate the outer housing in
relation to the inner
housing to perform a cleansing operation on the valve portion of the NC to
which the device is
attached. Such a disengaged, neutral, or rotating configuration can be
achieved by any suitable
approach, including by providing complementary engaging elements or structures
on adjacent
surfaces of the inner and outer housings that under certain conditions, for
example, when the
outer housing is pulled up., pushed down, or squeezed by a user in relation to
the inner housing,
engage each other; otherwise the engaging elements remain disengaged, which
allows rotation
of the outer housing in relation to the inner housing when the device is
secured to an NC.
Features that allow transitioning between engaged and disengaged positions
include springs or
biasing or resilient elements or materials. In other embodiments, when the
device is attached to
a needlefree connector, the inner and outer housings adopt an engaged
configuration relative to
each other such that they rotate in unison unless a user applies sufficient
force to the outer
housing to cause the engaging elements to disengage and thus allow the outer
housing to be
rotated independently of the inner housing.
The outer housing includes a cylindrical cavity designed to receive and retain
the inner
housing using one or more features or elements that allow the outer housing to
be rotated in
relation to the inner housing if and when desired. The cavity is formed by a
curved outer
sidewall that in some embodiments is joined to a top portion of the housing
about its periphery
and which also preferably has a concentric central matrix well or matrix
attachment region to or
with which the compressible cleansing matrix is attached or otherwise
associated, although in
some embodiments some degree of eccentricity between the matrix well and
central rotational
axis of the outer housing may be desired. In some embodiments, the outer
housing is formed by
a sidewall that is tapered and/or has one or more steps.
In some preferred embodiments, the inner surface of the top of the outer
housing
includes one or more inner housing engaging elements or structures (e.g.,
teeth) designed to
releasably engage complementary structures in the outer housing-engaging
region on the top of
the inner housing. Engagement of the outer housing's inner housing engaging
structure(s) with
those in the outer housing-engaging region of the inner housing allow a user
to rotate the outer
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housing and inner housing in unison, for example, as a capping and cleansing
device's inner
housing is screwed onto the threaded portion of a needlefree connector to be
cleansed and/or
capped. Once the device is releasably secured to a needlefree connector via
the inner housing,
the outer housing's inner housing engaging elements or structure(s) can be (or
are) disengaged
from the outer housing-engaging elements of the inner housing, for example, by
the biasing
action or resilience of a the compressible cleansing matrix, thereby allowing
a user to rotate the
outer housing about its central axis in relation to the inner housing. A
representative example
of such engaging structures is shown in published US patent application
publication no.
2018/0304067, although features such as an inner housing having an opening in
its top to allow
a compressible cleansing matrix attached to the inner surface of the top of
the outer housing to
extend into the bore of the inner housing so that it can contact surfaces of a
needlefree
connector upon connection of the former to the latter are also envisioned.
In some of these embodiments, the outer housing may include one or more vents
to
allow fluid and/or air from inside the device to escape as the capping and
cleansing device is
secured to a needlefree connector, while in other embodiments, no vent(s)
is(are) provided. In
embodiments with one or more vents, a membrane, filter, or other permeable or
semi-
permeable barrier may be employed to allow a unidirectional or bidirectional
flow of air, gas, or
vapor through the vent(s) but prevent the movement of microorganisms (e.g.,
bacteria, fungi,
viruses, etc.) into the capping and cleansing device of the invention.
In certain preferred embodiments, the outer surface of the outer housing of a
capping
and cleansing device according to the invention includes one or more grip-
enhancing structures
(e.g., a plurality of vertical ridges) or coatings. Such grip-enhancing
structures or coatings
facilitate a user's grasp of the housing of a capping and cleansing device
between her/his
fingers, which can be helpful not only during insertion and removal of a
needlefree connector
from the capping cleansing device, but also during the cleansing process,
where the user rotates
the outer housing in relation to the inner housing in order to scrub and
thereby clean or cleanse
the surface(s) of the inserted needlefree connector with the compressible
cleansing matrix of
the device.
In some preferred embodiments, the devices of the invention include one or
more
elements or features arrayed on facing surfaces of the inner and outer
housings that allow a
user to sense that the outer housing is rotating in relation to the inner
housing in order to
provide cleansing action on the valve surface of the NC to which the device is
attached. Such
sensory feedback can include one or more of auditory, tactile, and/or visual
stimuli generated
from the device by rotation of the outer housing in relation to the inner
housing.
In some of these embodiments, the devices of the invention comprise a
resilient inner
body disposed within a cap that can be rotated or turned in relation thereto
when the capping
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and cleansing device is secured to a needlefree connector, and a compressible
matrix element
containing one or more antimicrobial reagents and having a structure to allow
capped surfaces
of the needlefree connector to be cleansed. More specifically, the resilient
inner body has a wall
that forms a central, interior (preferably cylindrical) bore that extends
between oppositely
disposed first and second (or upper and lower, respectively) openings. The
interior wall of the
central bore nearer the second (lower) opening includes one or more thread-
engaging tabs (or
threads), preferably two thread-engaging tabs disposed opposite to each other.
The thread-
engaging tab(s)(or threads) is(are) are configured to engage a complementary
threaded region
on the exterior surface of, for example, a needlefree medical valve. This
allows the capping and
cleansing device to be securely threaded onto the targeted threaded portion of
a needlefree
connector for cleansing and, if desired, capping that portion of the
needlefree connector. The
exterior surface of the resilient inner body includes one or more structures
that allow it to
mechanically engage and disengage complementary structures disposed on an
inner surface of
the cap.
In many embodiments, the resilient inner body's exterior surface includes a
cap-
engaging region that includes one or more structures such as spaced
protrusions (e.g., teeth)
that allow the resilient inner body to mechanically engage and disengage
complementary
engaging structures on an interior surface of the cap. Preferred embodiments
of cap-engaging
structures include alternating teeth and grooves (or channels) arrayed about
the outer
circumference of the resilient inner body, which teeth and grooves are
complementary to one or
more spaced engaging structures (e.g., teeth) disposed on the inner surface of
the cap's outer
wall. In other embodiments, the cap-engaging region of the resilient inner
body is disposed on
its inner surface for engagement with one or more complementary engaging
structures (e.g.,
teeth) arrayed on the exterior or outer surface of matrix well wall. As will
be appreciated, in
configurations that include teeth and channels, the "teeth" can be raised
protrusions and the
"channels" can be the spaces or gaps between the raised protrusions.
The resilient inner body also includes a compressible region. In many
preferred
embodiments, it is located above the thread-engaging tab(s)(or threads) and
cap-engaging
region. The compressible region can be any structure that allows the resilient
inner body to be
compressed so as to bring the first and second openings closer together to
allow disengagement
of the engaging structures of the cap and resilient inner body. In preferred
embodiments, the
compressible region is a torsion spring, which in certain particularly
preferred embodiments is
a molded torsion spring formed from a plastic or other sufficiently flexible
or resilient material,
preferably during injection molding, as part of the resilient inner body.
In some embodiments, the resilient inner body is made from two or parts that
are then
assembled to form the complete inner body. For example, a resilient inner body
can be formed
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as two or more separate parts that are assembled, one on top of the other,
during manufacture
of the capping and cleansing device of the invention. For instance, in
embodiments where the
resilient inner body is made of two parts, the upper part preferably comprises
the compressible
region (e.g., a torsion spring formed during injection molding of the upper
part), while the lower
part comprises the cap-engaging region and the thread-engaging tab(s)(or
threads). In contrast,
a representative three-part embodiment of a resilient inner body includes an
upper section that
comprises the first (upper) opening and the compressible region, a midsection
that comprises
the cap-engaging region, and a lower section that includes the thread-engaging
tab(s)(or
threads) and second (lower) opening. In an alternative three-part embodiment,
the upper
section comprises the first (upper) opening and cap-engaging region, the
midsection comprises
the compressible region, and the lower section includes the thread-engaging
tab(s)(or threads)
and second (lower) opening. As will be appreciated, the invention encompasses
all possible
combinations of parts having a cap-engaging region, compressible region, and a
region to
engage the threads of the threaded portion of a needlefree connector, with the
proviso that the
final combination be capable of being compressed to provide cap-engaging and -
disengaging
functionality such that when corresponding structures on the cap and inner
body are engaged,
the cap and inner body can rotate together about their central axes, and when
the
corresponding structures on the cap and inner body are disengaged by
compression of the
compressible region, a user can rotate the cap about its central axis in
relation to, or
independently from (i.e., the cap spins while the resilient inner body does
not), the resilient
inner body.
In embodiments of the invention where the resilient inner body is made from
two or
more parts, those parts, once assembled, preferably are mechanically connected
such that they,
too, move in unison, for example, when the capping and cleansing device of
which they are a
part is threaded onto the threaded portion of a needlefree connector, for
example, a needlefree
connector. Any suitable mechanical lock, and corresponding set of mechanical
structures, can
be used to link such parts together.
In some preferred embodiments, the inner housing or resilient inner body also
includes
a sealing member (i.e... seal) configured to provide a fluid tight seal
between the capping and
cleansing device of the invention and an NC connected thereto. The seal is
preferably disposed
in a channel formed in the inner surface of the wall of the resilient inner
body proximate to the
second (lower) opening, typically below the thread-engaging tab(s)(or
threads).
Each device of the invention also includes a outer housing or cap in operable
association
with the inner housing such as a resilient inner body. A cap typically
includes an outer cavity
formed by a curved outer wall that is joined to a top portion, preferably
about the top portion's
periphery, and a preferably concentric central matrix well that extends from
the top's inner
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surface into the outer cavity. The wall forming the matrix well is spaced from
the cap's outer
wall to form a resilient member housing that can be accessed through an
opening created by the
gap between the cap's wall and the matrix well wall. In many preferred
embodiments, the inner
surface of the cap's outer wall includes one or more engaging or locking
structures (e.g., teeth)
designed to releasably engage (i.e., corresponding structures can be engaged
and disengaged, as
desired) complementary structures in the cap-engaging region of the resilient
inner body. In
other embodiments, the cap's engaging or locking structure(s) is (are)
disposed on the outer
surface of the matrix well wall, which locking structure(s) is (are) designed
to releasably engage
complementary structures in the cap-engaging region on the inner wall of the
resilient inner
body. Engagement of cap's engaging or locking structure(s) with those in the
cap-engaging
region of the resilient inner body allows a user to rotate the cap and
resilient inner body in
unison, for example, as a capping and cleansing cap is screwed onto the
threaded portion of a
needlefree connector to be cleansed and/or capped. Once the device is
releasably secured to a
needlefree connector, the cap's locking structure(s) can be disengaged from
those in the cap-
engaging region of the resilient inner body, thereby allowing a user to rotate
the cap about its
central axis in relation to the resilient inner body. In some embodiments, the
cap may include
one or more vents to allow fluid and/or air from inside the device to escape
as the capping and
cleansing device is secured to a needlefree connector, while in other
embodiments, no vent(s)
is(are) provided.
The capping and cleansing devices of the invention also include a compressible
cleansing matrix in the outer housing's matrix well. The compressible
cleansing matrix can be,
for example, an open-cell foam. The cleansing matrix is preferably secured to
an inner surface
of the outer housing so as to limit or restrict its rotation independent of
the outer housing
during outer housing rotation. The compressible cleansing matrix is configured
to contact and
cleanse one or more surfaces of a needlefree connector that contacts the
matrix upon a
needlefree connector's association with a capping and cleansing device of the
invention. The
compressible cleansing matrix attached to or otherwise associated with the
outer housing can
be axially compressed (i.e., compressed along the central axis of the outer
housing's matrix well)
upon insertion of a needlefree connector into a capping and cleansing device.
Because the needlefree connector surface(s) to be cleansed may be contaminated
with
microorganisms that form a biofilm (i.e., a matrix of microorganisms and
extracellular material
attached to a surface, which enables the microorganisms, typically bacteria
and/or fungi, to
adhere to a surface and carry out certain biochemical processes), the
compressible cleansing
matrix preferably has sufficient mechanical integrity when compressed to allow
its use to
disrupt any biofilm that may be present on a surface of the needlefree
connector that is
contacted by the cleansing matrix. Disruption of biofilm can occur by
rotating, twisting, or
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otherwise moving a then-compressed cleansing matrix in relation to the
needlefree connector
(e.g., a needlefree medical valve), for example, by rotating the outer housing
(to which the
compressible cleansing matrix is attached or otherwise associated or retained)
in relation to the
inner housing (e.g., a resilient inner body) of the capping and cleansing
device and the
needlefree connector to which inner housing is releasably attached. The
resulting friction
between the compressed cleansing matrix and surface of the needlefree
connector disrupts the
biofilm, thereby cleansing, and preferably sterilizing, the needlefree
connector. Leaving the
capping and cleansing device secured to (i.e., capping) the needlefree
connector after such
cleansing will limit, and preferably preclude, biofilm regrowth and/or the
microbial
recolonization of cleansed surfaces (which remain in contact with the
compressible cleansing
matrix) of the needlefree connector.
In preferred embodiments, the compressible cleansing matrix includes one or
more
cleansing reagent species dispersed therein, preferably at the time the device
is manufactured,
although in some embodiments, the cleansing reagent may be dispersed into the
matrix just
prior to the matrix coming into contact with a needlefree connector. in
embodiments of the
latter sort, the cleansing reagent is preferably housed in the body of the
capping and cleansing
device in a reservoir configured to rupture upon association of a needlefree
connector for
cleansing. Such a reservoir can be disposed between the matrix and needlefree
connector, or,
more preferably, between the rotatable cap and compressible cleansing matrix.
Preferred
cleansing reagents include antimicrobial reagents such as isopropyl alcohol,
chlorhexidine, and
silver ions. In some embodiments, the capping and cleansing device of the
invention will
include a valve or opening to allow liquid in the cleansing reagent to
evaporate.
in some preferred embodiments, the compressible cleansing matrix is comprised
of two
or more components. In some of such embodiments, one portion of the matrix is
attached to the
inner surface of the outer housing and another portion is secured to the inner
surface of the wall
forming the matrix well. If present, the portion of the compressible cleansing
matrix secured to
the inner surface of the matrix well wall is preferably configured to radially
compress upon
association with a needlefree connector to be capped and cleansed. When a
cleansing matrix is
comprised of two or more components, the matrix components may be made from
the same of
different material(s).
As described, the central matrix well is adapted to receive the compressible
cleansing
matrix. The surface(s) of the central matrix well in contact with the matrix
preferably includes
one or more retaining structures to retain the compressible cleansing matrix
so as to link its
rotation or movement to that of the cap, particularly when the engaging
structures of the cap
and resilient inner body are disengaged so as to allow cap rotation during a
needlefree
connector cleansing procedure. Such retaining structures include ridges and
other protrusions
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from the surface of central matrix well in contact with the compressible
cleansing matrix. An
adhesive can also be used to adhere that portion of the compressible cleansing
matrix to a
desired position in the matrix well.
In various embodiments, the outer surface of the outer housing of a capping
and
cleansing device according to the invention includes one or more grip-
enhancing structures or
coatings, e.g., a plurality of vertical ridges. Such grip-enhancing structures
or coatings facilitate
a user's grasp of the body of a capping and cleansing device between her/his
fingers, which can
be helpful not only during insertion and removal of a needlefree connector
from the capping
cleansing device, but also during the cleansing process, where the user
rotates the outer
housing in relation to the inner housing in order to scrub and thereby
clean/cleanse the
surface(s) of the inserted needlefree connector with the compressible
cleansing matrix.
The inner and outer housings can be made from any suitable material or
combinations
of different materials. Plastics are particularly preferred. The material(s)
used to manufacture
the outer housing may be the same or different as the material(s) used to
produce the inner
housing.
The outer housing and its various components are preferably formed as a
single,
integral unit during manufacturing (e.g., by injection molding). The inner and
outer housings
can be manufactured by any suitable process, including extrusion, injection
molding, and
additive manufacturing (e.g., 3D printing). After manufacturing, an inner
housing is inserted
into an outer housing to form a capping and cleansing device of the invention.
For securing the
inner and outer housings together as a functional subassembly that can
transition between
engaged and disengaged configurations to provide for unitary or independent
rotation of the
outer housing in relation to the inner housing, any suitable retaining
structure, or group of
structures, that provides for movement, i.e., rotation, of the outer housing
in relation to the
inner housing can be used. Such structures include attachment mechanisms such
as "snap-fit"
mechanisms where interacting parts are sufficiently flexible and have
preferably have tapered
surfaces so facilitate assembly.
A compressible cleansing matrix can be positioned in the matrix well before of
after an
inner housing and outer housing are operably associated. In preferred
embodiments, a suitable
adhesive is used to securely adhere the compressible cleansing matrix, or, if
the matrix
comprises two or more parts, its various portions, to one or more inner
surfaces of the outer
housing's matrix well. In some embodiments, the surface of the matrix well
that contacts the
compressible matrix includes a structure to assist in securely retaining the
matrix in the well,
thus ensuring that it moves in conjunction with the cap when the outer housing
is rotated
during a cleansing procedure.
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In preferred embodiments, the capping and cleansing devices include a
removable lid or
seal attached to the outer housing to seal the device, thus separating the
interior spaces and
structures of the device from the external environment Such a lid or seal
prevents exposure of
the devices's interior, including the inner housing and compressible cleansing
matrix, to the
environment until the seal is removed, typically by a healthcare worker just
prior to her/his use
of the capping and cleansing device to cap and then, if desired, to
dean/cleanse the needlefree
connector (e.g., needlefree medical valve) to which it is connected. In
preferred embodiments,
such cleansing substantially disrupts any biefilm that may exist on surfaces
contacted by the
compressible cleansing matrix. If desired, the capping and cleansing device
can be left in place
(typically after cleansing the needlefree connector attached thereto) in order
to cap the
needlefree connector until it is further accessed, thereby minimizing exposure
of capped
exterior surfaces of the connector to potential pathogen contamination (and
biofilm formation)
from the surrounding environment Seals are typically installed during
manufacture of a
capping and cleansing device of the invention. In those embodiments where the
capping and
cleansing devices are sterilized during manufacture (e.g., by irradiation,
exposure to ethylene
oxide, etc.), seals are preferably applied prior to sterilization.
Other aspects of the invention concern methods of cleansing and/or capping
needlefree
connectors using a capping and cleansing device according to the invention.
Such methods
typically involve transitioning the inner and outer housings from an engaged
to a disengaged
configuration after the device has been connected to a needlefree connector as
to allow the
outer housing to spin or rotate in relation to the inner housing. Such
compression facilitates
contact between the device's compressible cleansing matrix and the associated
surface(s) of the
needlefree connector. Spinning or rotation of the outer housing in relation to
the inner housing
and the associated surface(s) of the needlefree connector, allow those
surfaces to be scrubbed,
thereby cleansing them. Preferably, such cleansing methods provide for the
disruption of any
biofilm present on the surface(s) of the needlefree connector associated the
capping and
cleansing device. And in those embodiments where the compressible cleansing
matrix contains
one or more antimicrobial reagents, microbes and pathogens present in such
biofilm and/on on
such surface(s) are destroyed or rendered nonviable.
Herein, the compressible cleansing matrix of a capping and cleansing device of
the
invention comprises one or more cleansing reagent species dispersed in a
substrate. The
cleansing matrix substrate can be any substance that can conform, mold, or
compress in a
manner that enables the effective friction-based cleansing of the site or
portion of the
needlefree connector to be cleansed, including the top surface of the site,
side surface, and any
threads or grooves, if present, and provide the cleansing reagent at least at
a surface level.
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Examples of the compressible cleansing matrix include cotton, open or closed
cell foam such as
polyethylene foam, or other substance that can hold or carry the cleansing
reagent
In some embodiments, the cleansing reagent species is(are) dispersed in or
otherwise
combined with the compressible cleansing matrix during the process used to
manufacture the
capping and cleansing device, while in other embodiments, the device is
configured such that
the cleansing reagent(s) is(are) released for dispersion into the compressible
cleansing matrix
post-manufacture, but when or prior to the time the matrix is brought into
contact with the
needlefree connector to be cleansed. The cleansing reagent can be any
chemical, substance, or
material that cleans the site of bacterial or even viral microorganisms,
biofilm, etc., or any
carrier that contains such chemical, substance or material. Examples of
cleansing reagents
include isopropyl alcohol, chlorhexidine, chlorhexidine digluconate, povidone-
iodine, hydrogen
peroxide, soap, and hydrochloric acid, silver ions and salts (e.g., silver
acetate, silver lactate,
silver nitrate, etc.), etc.
In accordance with the invention, a cleansing reagent comprises an active
ingredient
capable of cleansing a surface of a needlefree connector. Any active
ingredient that can be used
effectively to rapidly cleanse a medical fitting or medical line connector
(e.g., a needlefree
connector) can be adapted for use in practicing the invention, and are
generally classified as
antibacterial and/or antifungal reagents, antiseptic or antimicrobial
reagents, wide spectrum
disinfectants, and/or parasiticides, as well as combinations of such reagents.
Particularly
preferred are biocompatible cleansing reagents, as the devices of the
invention are intended for
human and/or veterinary use, including alcohols, antibiotics, oxidizing
reagents, and metal salts.
Representative examples of such active ingredients include bleach,
chlorhexidine, ethanol,
isopropyl alcohol, hydrogen peroxide, sodium hydroxide, and an iodophor
dissolved or
otherwise dispersed in a suitable solution, suspension, or emulsion. Other
active ingredients
having suitable cleansing effects can also be used. These include alcohols
(e.g., ethanol, benzyl
alcohol, isopropyl alcohol, phenoxyethanol, phenethyl alcohol, etc.);
antibiotics (e.g.,
aminoglycosides, such as amikacin, apramycin, gentamicin, kanamycin, neomycin,
netilmicin,
paromomycin, rhodostreptomycin, streptomycin, and tobramycin; bacitracin;
chloramphenicol;
erythromycin; minocycline/rifampin; tetracycline; quinolones such as oxolinic
acid, norfloxacin,
nalidixic acid, pefloxacin, enoxacin and ciprofloxacin; penicillins such as
oxacillin and pipracil;
nonoxynol 9; fusidic acid; cephalosporins; etc.), quaternary ammonium
chlorides; quaternary
ammonium carbonates; benzalkonium chloride; chlorinated phenols; fatty acid
monoesters of
glycerin and propylene glycol; iodine; iodine containing compounds, such as 3-
iodo-2-propynyl
butyl carbamate (IPBC); iodophors, such as povidone-iodine (Betadine 100%,
which contains
providine iodine as the active ingredient); hydantoinsõ such as
dimethylhydantoin and
halogenated hydantoins; isothiazolinones; parabens, such as methylparabenõ
ethylparabenõ and
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propylparaben; chloroxylenol; chlorhexidine and its salts;
chlorhexidinefsilver-sulfadiazine;
chlorhexidine acetate; chlorhexidine gluconate (e.g., Hibiclens);
chlorhexidine hydrochloride;
chlorhexidine sulfate; benzoic acid and salts thereof; benzalkonium chloride;
benzethonium
chloride; methylbenzethonium chloride; chlorobutanol; sorbic acid and salts
thereof; imidazole
antifungals (e.g., miconazole); butocouazole nitrate; mafenide acetate;
nitrofurazone;
nitrornersol; triclocarban; phenylmercuric nitrate or acetate (0.002%);
chlorocresol; chlorbutol;
clindamycin; CAE (Anjinomoto Co., Inc., containing DL-pyrrolidone carboxylic
acid salt of L-
cocoyl arginine ethyl ester); cetylpyridinium chloride (CPC) at 0.2%, 0.02%,
and 0.002%
concentrations; 9.8% isopropyl alcohol; 1% ZnEDTA; mupirocin; and polymyxin
(polymyxin b
sulfate-bacitracin). Additionally, other useful compounds and compositions
include Miconazole,
Econazole, Ketoconazole, Oxiconizole, Haloprogin, Clotrimazole, butenafine
HC!, Naftitine,
Rifampicin, Terbinafine, Ciclopirox, Tolnaftate, Lindane, Lamisil,
Fluconazole, Amphotericin B,
Ciprofloxecin, Octenidine, Triclosan (2,4,4'-trichloro-21-hydroxydiphenyl
ether), Microban (5-
chloro-2phenol (2,4 dichlorophenoxy). Useful metals include silver and its
salts, including silver
acetate, silver benzoate, silver carbonate, silver citrate, silver iodate,
silver iodide, silver lactate,
silver laurate. silver nitrate, silver oxide, silver palmitate, silver
protein, and silver sulfadiazine.
Cleansing reagents are often compositions that comprise the desired active
ingredient(s) in
admixture with other ingredients, such as carriers and liquid solvents.
The particular active ingredient(s) selected as a cleansing reagent for a
given application
will be compatible with the compressible cleansing matrix and material(s) used
to form the
outer housing, inner housing, and other components of the particular device.
In some
embodiments, the cleansing reagent is dispersed in the compressible cleansing
matrix after the
matrix is formed. For example, a cleansing reagent can be dispersed by
saturating or
supersaturating a compressible cleansing matrix during manufacture of the
device, preferably
before it is sealed. In other embodiments, the cleansing reagent can be
dispersed during the
process used to manufacture the compressible cleansing matrix. As will be
appreciated, the
materials used to prepare the cleansing reagent should be compatible with the
constituent or
constituents that comprise the compressible cleansing matrix such that the
substrate does not
appreciably degrade or otherwise suffer loss of structural integrity prior to
being used to
cleanse a needlefree connector (e.g., a needlefree medical valve). Similarly,
the cleansing
reagent should be biocompatible, such that it will not harm a patient in the
event of contact or
should some amount of the cleansing reagent be admitted into the fluid-
carrying portion of a
needlefree medical valve, as well as with materials used to form needlefree
medical valves (or
other needlefree connector).
In preferred embodiments, the material used to form the compressible cleansing
matrix
is any suitable absorbent, compliant pliable, resilient, fibrous, or porous
material, or
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combination of materials, than can be wetted and/or impregnated with a
cleansing reagent and
which can easily and readily adapt to complex surface contours (e.g., luer
threads, concave and
convex surfaces, flanges, etc.) likely to be engaged upon contact with, for
example, a needlefree
medical valve to be cleansed. Such materials include those that are synthetic
or naturally
occurring, and they may be of homogeneous or heterogeneous composition.
Preferred synthetic
materials include fibrous, foam (e.g., a felted foam), and gel compositions,
particularly those
having directionally oriented natural or synthetic fibers, or combinations
thereof. Preferred
naturally occurring materials useful as substrates include fibrous naturally
occurring materials,
including plant-derived materials such as cotton and paper products, as well
as animal-based
fiber products such as wool. Other preferred natural materials are sponges.
As will be appreciated, in order to achieve the desired cleansing effect, a
compressible
cleansing matrix, or the component part(s) thereof designed to contact a
needlefree connector
such as a needlefree medical valve, preferably are made of a material (or
combination of
materials) that allow the cleansing element to thoroughly cleanse surfaces of
needlefree
connectors such as needlefree valves or luer access devices, particularly
those surfaces that are
exposed to air and thus are at risk for contamination with infectious or
pathogenic reagents, and
biofilms containing the same, and are also intended to form part of the fluid
flow path for fluids
to be introduced into a patient for example, IV solutions, medications, blood
and blood
products, etc.
Preferably, the material used to produce the compressible cleansing matrix
should be
sufficiently compliant to allow the compressible cleansing matrix to deform
under the pressures
experienced during normal use in order to allow it to conform to the external
structures present
on the surface(s) of the needlefree connector to be cleansed. This assures
intimate, cleansing
contact between the compressible cleansing matrix and at least those exposed
surfaces of, for
instance, a needlefree connector designed to come into contact with fluid
entering the valve,
such as IV fluids. In addition, the compressible cleansing matrix preferably
allows for the
retention of a liquid cleansing reagent, for example, in capillary spaces, in
the void volume of
foams, sponges, etc. The compressible cleansing matrix may also be engineered
such that it
includes cleansing reagents such as silver ions and/or other suitable
materials.
Preferred natural materials from which compressible cleansing matrices can be
formed
include those derived from cotton and naturally occurring sponges. As those in
the art
appreciate, processed cotton fibers are composed almost entirely of the
natural polymer
cellulose. In such fibers, 20-30 layers of cellulose are coiled into a series
of spring
configurations, which makes the fibers absorbent and gives them a high degree
of durability and
strength. For example, woven cotton sheets, as are often used in the
manufacture of sterile
cleansing pads that are then saturated with a 70% isopropyl alcohol (IPA)
solution, can be used
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as substrates for cleansing elements according to the invention. Any suitable
configuration may
be used. For example, a woven cotton sheet can be cut into numerous similarly
sized pieces,
each of which can be used as a substrate. In many embodiments, after
attachment to the inside
surface of a layer of the container (e.g., through the use of an adhesive,
double-sided, tape, etc.),
the matrix is ready for the addition of a suitable cleansing reagent.
Alternatively, cotton fibers
can be spun onto the inside surface of the cap. Other fibers, be they
naturally occurring,
synthetic, or combinations of natural and synthetic materials, having similar
properties can also
readily be adapted for use as compressible cleansing matrices.
Another class of materials for compressible cleansing matrix fabrication is
directionally
oriented fibrous materials. These include, without limitation, materials
comprised of cellulose
fibers, glass fibers, and polyester fibers, as well as materials comprised of
combinations of two
of more of these and/or other materials. Such bonded synthetic fibers use
capillary action to
precisely absorb, retain, transfer, and/or release liquids or vapor in desired
amounts. A broad
range of synthetic polymers can be used to form the fibers, and, if desired,
they may be treated
for functional purposes, for example, to contain a cleansing reagent dispersed
therein, to
provide a vapor barrier or other coating over a portion of the product's
surface, etc. The
geometric shape of these materials can also be customized for particular
applications, thereby
permitting easy integration into substrate configurations having the desired
device thickness,
widths, length, diameter, etc.
Other representative classes of materials suitable for use as compressible
cleansing
matrices include gel-forming polymers and foams such as agarose, agar,
polyacrylamide, and
other synthetic porous materials that can be formed into layers, sheets,
columns, or other
shapes compatible with practicing the invention. Representative gelatinous
materials include
hydrogels (i.e., cross-linked polymers that absorb and hold water),
particularly those made from
agarose, (2-hydroxyethyl)methacrylate and its derivatives, and synthetic
carbohydrate
acrylamides.
Still other classes of materials include porous polymer sponges. Such sponges
can be
formed from any suitable material, including polyethylene, polypropylene,
olytetrafluoroethylene, polyvinylidine difluorideõ polynitrile, and
polystyrene. Many such
porous polymer sponges are commercially available in a wide variety of shapes,
pore density
and size, etc. Additionally, polymer sponges can be made by polymerizing
appropriate
monomers according to conventional foam forming techniques. In general,
sponges have an
open pore structure to allow movement of a solvent such as a liquid cleansing
reagent The
sponge surface should include open pores to provide entry of liquid cleansing
reagents (e.g.,
alcohol, iodine-containing solutions, etc.), and, as with other materials used
to form matrices,
the particular material chosen is preferably inert i.e., not reactive with
components of the
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cleansing reagent, the body of the capping and cleansing device, or the
materials used to
produce needlefree connectors such as needlefree medical valves.
Surgical foams are another preferred class of materials that can be used to
make
compressible cleansing matrices. The materials can be natural or synthetic, as
desired. Suitable
foams include rubber latex, polyurethane, polyethylene and vinyl foams.
Preferably, such foams
are made from any suitable biocompatible polymer, for example, polyvinyl
alcohol (PVA) or
polyurethane. One preferred foam material is MicrobisanTM, a hydrophilic
polyurethane foam
that is impregnated with silver ions (I,endell Manufacturing, St Charles, MI).
Preferably, such
foams are highly absorbent and thus suitable for use with liquid cleansing
reagents. In other
embodiments, the material used to form the foam is well-suited for dispersion
of a dry cleansing
reagent, such as silver ions. Again, it is preferred that foam materials, if
used to as a substrate,
be inert Also, they are preferably sufficiently flexible to conform to the
variety of different
shapes and surface configurations (e.g., double seal fluid access points, luer
threads, etc.)
encountered in the field given the multitude of medical valve shapes, sizes,
and configurations.
In this way sufficient contact between the cleansing surface(s) of the capping
and cleansing
device and the surface(s) of the needlefree connector to be cleansed can be
ensured. Another
advantage of some synthetic foams (as well as certain other polymeric
materials from which
substrates may be formed) is that they can easily be injected in a desired
volume into a shell or
housing during manufacture, after which they expand to assume the desired
substrate size,
density, porosity, etc.
Furthermore, compressible cleansing matrices can include chemicals to indicate
a
functional change therein, for example, by using a color change to signal a
change from a wet to
a dry state, or, alternatively, that the matrix material has been properly
wetted with a liquid
cleansing reagent dispersed into the substrate by a health care worker just
prior to use, as
opposed to during manufacture of the device. Thus, depending on the system
used, a color
change in the matrix could be used to indicate that the cleansing reagent in
the compressible
cleansing matrix has evaporated prior to use and thus the particular cleansing
device should not
be used, perhaps due to a leak in the capping and cleansing device 's storage
container.
Alternatively, when, for example, a colored liquid cleansing reagent is used,
the user can visually
confirm dispersion of the reagent in the matrix by assessing whether the
colored cleansing
reagent is dispersed throughout the matrix. When colored cleansing reagents
are used, it is
preferred that the material(s) use to make the resilient inner body and/or cap
of the capping
and cleansing device be clear or translucent, or include one or more clear or
translucent
windows, in order to allow easy visualization of any color change prior to or
during use of the
capping and cleansing device.
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Capping and cleansing devices of the invention and their constituent parts
(e.g., the
resilient inner body, cap, compressible cleansing matrix, sealing ring, seal,
etc.) can be made
from any suitable material(s) and assembled using any suitable process.
Preferably, the outer surface of a capping and cleansing device 's outer
housing intended
for grasping by a user has a non-slip surface, i.e., one having a high
coefficient of friction so that
when the outer portion of a capping and cleansing device is held in a user's
fingers and
positioned to cleanse a needlefree connector so that the outer housing can be
rotated in relation
to the inner housing and needlefree connector with minimal or no slippage
between the device
and the user's fingers (gloved or ungloved). Examples of such non-slip (or
high friction)
surfaces include those having ridges, valleys, dimples, bumps, or other
features designed to
enhance friction, as well as combinations of two or more of such features.
Such features can be
introduced into a device's outer surface(s) as part of the manufacturing
process. Alternatively, a
non-slip coating can be applied to one or more of the outer surfaces of the
outer housing.
in general, the capping and cleansing devices of the invention are provided to
users in a
sealed, sterile manner. if desired, labeling information, logos, artwork,
manufacturing, and/or
regulatory data (e.g., lot number, expiration or "use by" dates, etc.) may
also be printed or
otherwise applied to individual capping and cleansing devices. In addition,
information such as
a bar code (to allow use of the device to tracked, for example) may also be
included on
individual capping and cleansing devices.
As will be appreciated, cleansing devices may be packaged individually or in
groups of
two or more units as kits, which can further include instructions for use of
the capping and
cleansing device(s), as well as other information, logos, artwork,
manufacturing, and/or
regulatory data.
in preferred embodiments, packaged capping and cleansing devices are
sterilized using
a suitable process, such as irradiation. in a particularly preferred practice,
the capping and
cleansing device s of the invention are sterilized as part of the
manufacturing process. Here,
"sterilization" refers to any process that effectively kills or eliminates
transmissible reagents,
e.g., bacteria, viruses, fungi, prions, spores, etc. that may be present in
any component of a
device according to the invention. In preferred embodiments, sterilization can
be achieved by
heating. chemical treatment irradiation, and other processes. Indeed, any
sterilization process
compatible with the materials used to make the capping and cleansing device
can be employed.
A particularly preferred sterilization process is an irradiation process. Such
processes include
irradiation with x-rays, gamma rays, or subatomic particles (e.g., an electron
beam). In general,
when a sterilization process is used in the context of the invention, the
process is employed on a
cleansing article after it has been sealed and/or packaged. Chemical
sterilization processes can
also be used, for example, sterilization using ethylene oxide (Et0).
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The invention also concerns methods of using the instant single-use capping
and
cleansing devices of the invention. Such methods include using the devices to
cleanse and, if
desired, cap needlefree connectors such as needlefree connectors, luer access
devices, and the
like. To perform such methods, the portion of a needlefree connector to be
cleansed is threaded
into the central bore of the inner housing of a capping and cleansing device,
typically after the
user (e.g., a nurse) removes a seal that spans the opening in the device. Such
insertion brings
the site of the needlefree connector into contact with (i.e., brought into
cleansing association
with) the compressible cleansing matrix portion(s) of the device. In preferred
practice, once the
compressible cleansing matrix is in contact with the surface(s) of the
needlefree connector to be
cleansed, the outer housing automatically disengages the engaging elements in
the inner and
outer housings to allow rotation of the outer housing in relation to the inner
housing and
needlefree connector previously releasably connected to capping and cleansing
device. Such
contact and cleansing action can be for any desired period, with periods of
about one second to
about ten to twenty seconds being particularly preferred.
After cleansing, the needlefree connector can be removed from the capping and
cleansing device, after which the capping and cleansing device may be
discarded. Alternatively,
after cleansing, the capping and cleansing device can be left attached to the
needlefree
connector, capping a portion thereof until such time as access to the
needlefree connector is
desired, capping it and protecting it from contamination. At that time, the
capping and
cleansing device can be removed and discarded. If desired, just prior to
removal, a cleansing
process can be repeated.
After removal of a capping and cleansing device from a cleansed needlefree
connector, a
fluid-containing medical reservoir (e.g., a syringe containing a medication,
an IV bag, etc.) may
be immediately connected to the cleansed needlefree connector. In preferred
embodiments
where the cleansing reagent is a solution, the surface(s) of the needlefree
connector is
preferably allowed to dry (or is(are) dried, for example, by wiping with a
sterile, absorbent
cloth or wipe, which cloth or wipe may be dry or wetted with a volatile,
compatible solution
such as 70-100% alcohol) prior to connecting the needlefree connector to a
fluid reservoir. In
preferred practice, such cleansing methods result in at least a 2-fold, 5-
fold, or '10-fold or more
reduction in microorganism contamination on the accessible surface(s) that
have been cleansed.
Even more preferably, the level of reduction may exceed a 100-fold, a 103-
fold, a 101-fold, a 105-
fold, a 106-fold, or 107-fold reduction in microorganism contamination on the
accessible fitting
surface.
In addition to methods for cleansing accessible surfaces of luer access
devices and the
like, the devices of the invention provide methods of reducing infection risk
in a patient
connected to devices, such as a peripheral IV line, a central IV line, or a
peripherally inserted
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central catheter, configured for delivering fluids directly into the patient's
blood stream. The
risk reduction afforded by the devices of the invention may vary depending
upon many factors,
such as patient age and condition, the condition being treated, the location
where medical
services are being delivered, patient density, the level of contaminating
microorganisms in the
environment the quality of air handling equipment in the medical facility, the
degree of training
of medical personnel charged with cleansing the access device, the method(s)
used to
periodically cleanse the medical fitting, intervals between cleansing
procedures, the particular
configuration of the capping and cleansing device, the particular
configuration of the needlefree
connector, whether the capping and cleansing device is left on the cleansed
site of the
needlefree connector in order to provide capping, etc. Risk reduction can be
established using
any suitable method, for example, by assessing HAI frequency in the presence
and absence of
using cleansing devices according to the invention. Reductions of HAI
infection risk of 1-100%
or more, including up to 1000% or more, are envisioned through use of capping
and cleansing
devices according to the invention. As will be appreciated, reductions in
infection risk (e.g., HAI
risk) will translate to improved patient outcomes (through reduced morbidity
and mortality)
and reduced expenditure on treating HAI's.
Representative Embodiments
To further illustrate and describe certain preferred, representative
embodiments of the
invention, the reader is directed to the appended drawings, Figures 1-10,
which illustrate
various particularly preferred embodiments of the capping and cleansing
devices of invention.
A description of these preferred, representative embodiments follows.
Figure 1 shows several drawings ((a)-(g)) of a representative capping and
cleansing
device of the invention (10), its constituent parts (views (b)-(g)), and the
device associated with
a needlefree connector (view (a)). The constituent parts include a cap having
a cap portion (11)
adapted to receive and retain the compressible cleansing matrix (80) and a
resilient inner body
(30) associated with the cap portion (11) and adapted to engage one or more
complementary
features of the cap portion so as to prevent the cap portion and resilient
inner body from
moving independently of each other under certain conditions while under other
conditions
allowing the cap portion (11) and to move independently of each other. For
example, after
attaching the device (10) to a needlefree connector (100) (producing a capped
needlefree
connector (200)), a user an compress the resilient inner body (30) of the
device (10) by
applying pressure to compress the cap (10) against the needlefree connector
(100) so as to
allow the cap (10) to be rotated in relation to the resilient inner body (30)
and the needlefree
connector (100). Such action brings the compressible cleansing matrix (80) and
surface(s) of
the needlefree connector (100) desired to be cleaned, for example, the valve
surface of a
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needlefree medical valve, into contact, and rotation of the cap (10) in
relation to the needlefree
connector (100) creates friction that can disrupt for example, biofilm that
may be present on
the needlefree medical valve's valve surface, which surface can be in the
fluid path of fluids
moving through the medical valve.
Figure 2(a) is an exploded view of a representative capping and cleansing
device of the
invention (10) and a needlefree connector (100). Visible are the cap (10),
including its cap
portion (11) into which the compressible cleansing matrix (80) and resilient
inner body (30)
are positioned, and a luer-based needlefree connector (100) that is a
needlefree medical valve,
the male end (105) of which has a collar (101) and threads (102) for
connecting the valve to a
female threaded portion of a complementary luer fitting of another needlefree
connector (not
shown). View (b) is a cross-section side view of the cap (10) shown in view
(a) while it was still
sealed with a seal (90). As shown, the cap portion (11), compressible
cleansing matrix (80), and
resilient inner body (30) are operably assembled. The compressible cleansing
matrix (80) is
preferably positioned in a matrix well (12) formed into and protruding from
the inner surface of
the cap portion (11). The height of the matrix well (12) should allow
retention of the
compressible cleansing matrix (80), and in some embodiments it can be sized to
act as a stop
that can bear against the collar of a needlefree connector (100) to which the
cap is attached
when the cap is compressed by a user and rotated to cleanse desired surfaces
of the needlefree
connector (100).
Views (c) and (d) of Figure 2 show the cap (10) threaded onto the medical
valve (100) in
capping and cleansing configurations (views (c) and (d), respectively). As
shown in these views,
the compressible cleansing matrix (80) of the cap (10) bears against the valve
surface of the
valve stem portion (103) of the medical valve (100). In the capping view, view
(c), the cap (and
compressible cleansing matrix (80)) is not compressed. The diameter of the
matrix well (12)
allows the cap to slide over the threads (102) of the medical valve (100) when
the cap is pushed
toward the medical valve (100) by user wishing to cleanse the surface of the
valve stem portion
(103). View (d) shows the cap (10) compressed against the medical valve (100).
User-induced
compression results in the cap portion (11) moving closer to the body of the
medical valve
(100) by virtue of compression of the resilient inner body (30) and
compressible cleansing
matrix (80). This motion also results in disengagement of the complementary
mechanical
retaining elements of the cap portion (11) and resilient inner body (30), thus
allowing the user
to rotate cap portion (11) and the compressible cleansing matrix (80) of the
cap in relation to
the valve surface, thereby allowing cleansing of that surface.
Figure 3 shows six different views of a representative capping and cleansing
device of
the invention. Views (a)-(c) show the device (10) in a static, non-compressed,
non-rotable
position, where the cap portion (11) and resilient inner body (30) are engaged
such that the cap
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(10), and hence the compressible cleansing matrix (80) associated therewith,
cannot rotate in
relation to the device's resilient inner body (30). Views (d)-(1) show the
same representative
device (10) with the cap portion (11) and resilient inner body (30) in movable
relation such
that the cap portion ((11), and the compressible cleansing matrix (80)
associated therewith)
can be rotated in relation to the device's resilient inner body (30). The
inner surface of the
resilient inner body (30) includes one or more (preferably two) tabs (35) to
engage the threads
of a needlefree connector (100). In the embodiments shown in the Figures, the
outer surface of
the resilient inner body (30) includes a plurality of teeth (33) or other
structures spaced about
the resilient inner body's outer circumference designed to engage
complementary spaced
structures (e.g., ribs (18)) spaced on the inner surface of the cap portion
(11). When the cap
(10) is uncompressed, the teeth (33) engage the ribs (18) and effectively lock
the cap portion
(11) and resilient inner body (30) together so that they rotate together. This
enables the cap
(10) to be threaded, for example, onto a complementary fuer fitting of a
needlefree connector
using the tabs (35) on the inner surface of the resilient inner body (30) in
order to provide a
capping function (to remove the cap from the needlefree connector, the process
is reversed). To
provide cleansing action, once secured to the needlefree connector, the cap
(10) can then be
compressed by a user, which pushes the cap portion (11) toward the needlefree
connector's
fitting and compresses the compressible cleansing matrix (80) against the
surface(s) of the
connector (100) to be cleansed.
Figure 4 shows views of the cap portion (11) of a representative capping and
cleansing
device (10) of the invention. View (a) shows a top view of the cap portion
(11). Also visible on
portions of the outer surface of the cap portion (11) are ridges and valleys
that provide for
enhanced friction, allowing a user to better grip or grasp the cap (10). View
(b) shows a side
view of the cap portion (11). View (c) shows a bottom view of the cap portion
(11). Visible in
this embodiment are six ribs (or protrusions) (18) evenly spaced (here, about
60 deg. on center)
about the circumference of cap portion's inner surface. The ribs (18) are
positioned and sized
to engage complementary features on the outer surface of the resilient inner
body (30)(not
shown). The wall forming the matrix well (12) is also visible in this view.
View (d) shows a
cross-sectional view of the cap portion (11). The well (20) formed by the
matrix well wall (12)
that extends from the inner surface of the upper portion of the cap portion
(11) is also
represented, and is adapted to receive and retain the compressible cleansing
matrix (80). In
preferred embodiments, an adhesive (not shown) or other bonding reagent is
used to adhere
the compressible cleansing matrix (80) inside the well (20). The well (20) is
spaced from the
outer wall of the cap portion (11). The resulting space is sized and adapted
for insertion of the
resilient inner body (30), about which the cap portion (11) can be rotated
when the
complementary retaining elements (e.g., ribs (18) and teeth (33)) of the cap
portion (11). In the
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representative embodiment of the inventive capping and cleansing device (10)
depicted in the
Figures, the upper surface (19) of the retaining elements (18) present in the
cap portion (11)
are designed to engage the lower surface of the locking grooves (34) between
the teeth (33).
Figure 5 shows seven different views ((a)-(g)) of the resilient inner body
(30) of a
representative capping and cleansing device of the invention (10).
Representative
measurements of this particular embodiment are shown on several of the views.
Depicted in
this embodiment are two thread tabs (35) disposed on the inner surface of the
wall (36) of
resilient inner body (30), 12 spaced teeth (33) to engage 12 complementary
retaining elements
(e.g., ribs (18)) on the inner surface of the cap portion (11). The resilient
inner body (30) is
adapted for compression by a user upon application of a suitable force, and
rebound upon
relieving of such pressure.
Figure 6 shows five different views ((a)-(e)), three of which show a
compressible
cleansing matrix portion (80) of a representative capping and cleansing device
of the invention
(10). Views (a)-(c) show top, side, and bottom views of this particular
compressible cleansing
matrix (80). Preferably, the compressible cleansing matrix (80) is adhered
using an adhesive to
the surface of matrix well (20) of the cap portion (11). Views (d) and (e) of
Figure 6 show
bottom and side views of a seal portion (90) of a representative capping and
cleansing device of
the invention. The seal (90) is typically sized to seal or cover the opening
that allows access to
the interior of the cap (10). Preferably, the seal contains one or more
removal tabs (91)
configured to allow grasping by a user such that the seal can be removed just
prior to the device
being used to cap and/or cleanse a needlefree connector (100). Preferably, the
seal is adhered
to the cap (10) using a suitable adhesive (94) applied to the inside surface
(92) of the seal (90).
The seal's outside surface (93) often will contain alphanumeric characters,
bar code
information, or the like.
Figure 7 (Figs. 7A-7E) shows five different views of another representative
capping and
cleansing device of the invention (300) in which a user engages the inner and
outer housings
(320, 301) by squeezing (or applying pressure using two or more fingers) the
outer housing
(301), causing it to deform slightly and move inner housing engaging elements
(311) present on
the inner surface of the outer housing's sidewall so that one or more them
(typically on opposite
sides of the outer housing (301)) engage outer housing engaging elements (326)
present on the
exterior surface of the inner housing (320) below the inner housing retaining
element (322) on
the outer surface of inner housing's sidewall (321). The top of the outer
housing (309)
integrates with the outer housing's sidewall (302). Fig. 7A shows an exploded
perspective view
of the device (outer housing (301), compressible cleansing matrix (305), and
inner housing
(320)) and an NC (100) to which the device (300) is to be connected (see Figs.
7B, 7E). The NC
(100) has threaded valve region (105) that includes a collar (101) below the
threaded portion
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(102). The valve surface (110) is disposed on top of the threaded valve region
(105). In Figs.
7A-7E, the valve is not depicted.
Fig. 7B shows a perspective view of the assembled device (300) depicted in
Fig. 7A
secured to the threaded region of the valve portion (105) of the NC (100)
depicted in Fig. 7A.
Preferably, the plastic used to injection mold the outer housing (301) of the
device (300) shown
in this embodiment is softer than the plastic used to mold the inner housing
(302). Preferably.,
the plastic used to form the outer housing is sufficiently pliable to allow it
to be squeezed by a
user to allow engagement of between the inner and outer housings' engaging
elements (326,
311) for purposes of attaching and removing the device (300) from the NC (100)
but resilient
enough to allow the outer housing (301) to return to its original shape and
thus allow the inner
and outer housings' engaging elements (326, 311) to become disengaged. This
allows a user to
rotate the outer housing (301) and matrix 305) in relation to the NC (100) in
order to cleanse its
valve surface (110) when a cleansing operation is performed, for example, by
rotating the
device (300) without engaging the inner and outer housings' engaging elements
(326, 311) a
sufficient period of time (e.g., 1 - 15 seconds or more) and/or for a desired
amount of rotation
(e.g., 360 to 3,600 or more degrees) in the same or different directions.
Fig. 7C shows an exploded cross-section view of the components depicted in
Fig. 7A. In
addition, the thin, flexible lip seal (324) with a tapered profile integrated
into the top surface of
the inner housing (320) is designed to engage with the sealing surface (308)
at the bottom of
the matrix well, which includes a matrix cavity (303) into which matrix
retaining ribs (307)
protrude and allow rotational forces applied by a user to the device (300) to
be translated to the
compressible cleansing matrix (305). The threads (326) on the inner surface of
the inner
housing (320) are designed to engage the complementary threads (102) in the
threaded region
(105) of the NC (100).
As will be appreciated, and as shown in Figs. 7C-7E, the compressible
cleansing matrix
(305) is inserted into the matrix well (303) during manufacture. The matrix
(305) can be
impregnated with a cleansing reagent (e.g., silver ions), and in preferred
embodiments, a liquid
disinfectant such as a 70% IPA solution. The bearing surface (323) of the
outer housing
retaining element (322), here a tapered flange molded as part of the inner
housing (320) during
manufacture, is designed to ride on the complementary bearing surfaces (310)
disposed on the
inner surface of the outer housing's main cavity (304). The inner housing
retaining elements
(306) of the outer housing (301) provide for retention of the inner housing
(320) in the outer
housing's main cavity (304) after the inner housing assembled into a
functional subassembly
with the outer housing during manufacture. For example, the inner housing may
be urged into
the outer housing with sufficient force to join them into a functional
subassembly ready for
insertion of compressible cleansing matrix (305) followed by instillation of a
liquid disinfectant
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(e.g., a 70% IPA solution), sealing, packaging, and sterilization. The inner
housing engaging
elements (311) present on the inner surface of the outer housing's sidewall
(302) allow the
outer housing (302) to engage outer housing engaging elements (326) on the
adjacent outer
surface of the inner housing (320).
Fig. 7D, the cross section view shows the components of the device of the
invention
(outer housing (301), compressible cleansing matrix (305), and inner housing
(320)) assembled
into a functional capping and cleansing device (300) ready for attachment to
the threaded
region of the valve portion (105) of the NC depicted in Fig. 7A. When the
device (300) is
attached to an NC (100), the NC contacting surface of the matrix (305)
contacts the valve surface
(110) of the NC, allowing that surface to be cleansed by a user rotating the
device (300) in
relation to the NC. Fig. 7E is a cross section showing the capping and
cleansing device (300) of
the invention screwed onto the NC, which results compression of the
compressible cleansing
matrix (305) against the NC's valve surface (110).
Figure 8 (Figs. 8A-8E) shows five different views of another representative
capping and
cleansing device of the invention. This embodiment is similar to that depicted
in Figure 7 (Figs.
7A-7E)m the difference being that in the embodiment shown in Figure 8 the seal
is not a lip seal
(324) located on the inner housing (320) but a tapered, downwardly extending
seal (408)
disposed on the bottom surface of the component forming the matrix well (403)
in the outer
housing (401).
Fig. 8A shows an exploded perspective view of this device embodiment (400)
(outer
housing (401), compressible cleansing matrix (405), and inner housing (420))
and an NC (100)
to which the device (400) is to be connected (see Figs. 88, 8E). Fig. 88 shows
a perspective view
of the assembled device (400) depicted in Fig. 8A secured to the threaded
region of the valve
portion (105) of the NC depicted in Fig. 8A. Fig. 8C shows an exploded cross-
section view of the
components depicted in Fig. 8A, while in Fig. 8D, the cross section view shows
the components
of the device of the invention (outer housing, compressible cleansing matrix,
and inner housing)
assembled into a functional capping and cleansing device ready for attachment
to the threaded
region of the valve portion of the NC depicted in Fig. 8A. Fig. 8E is a cross
section showing the
capping and cleansing device of the invention screwed onto the NC, which
results compression
of the compressible matrix against the NC's valve surface.
Specifically, Figure 8 (Figs. 8A-8E) shows five different views of another
representative
capping and cleansing device of the invention (400) in which a user engages
the inner and outer
housings (420, 401) by squeezing (or applying pressure using two or more
fingers) the outer
housing (401), causing it to deform slightly and move inner housing engaging
elements (411)
present on the inner surface of the outer housing's sidewall so that one or
more them (typically
on opposite sides of the outer housing (401)) engage outer housing engaging
elements (426)
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present on the exterior surface of the inner housing (420) below the inner
housing retaining
element (422) on the outer surface of inner housing's sidewall (421). The top
of the outer
housing (409) integrates with the outer housing's sidewall (402). Fig. 8A
shows an exploded
perspective view of the device (outer housing (401), compressible cleansing
matrix (405), and
inner housing (420)) and an NC (100) to which the device (400) is to be
connected (see Figs. 8B,
8E). The NC (100) has threaded valve region (105) that includes a collar (101)
below its
threaded portion (102). The valve surface (110) is disposed on top of the
threaded valve region
(105). in Figs. 8A-8E, the valve of the NC (100) is not depicted.
Fig. 8B shows a perspective view of the assembled device (400) depicted in
Fig. 8A
secured to the threaded region of the valve portion (105) of the NC (100)
depicted in Fig. 8A.
Preferably, the plastic used to injection mold the outer housing (401) of the
device (400) shown
in this embodiment is softer than the plastic used to mold the inner housing
(402). Preferably,
the plastic used to form the outer housing is sufficiently pliable to allow it
to be squeezed by a
user to allow engagement of between the inner and outer housings' engaging
elements (426,
411) for purposes of attaching and removing the device (400) from the NC (100)
but resilient
enough to allow the outer housing (401) to return to its original shape and
thus allow the inner
and outer housings' engaging elements (426, 411) to become disengaged. This
allows a user to
rotate the outer housing (401) and matrix 405) in relation to the NC (100) in
order to cleanse its
valve surface (110) when a cleansing operation is performed, for example, by
rotating the
device (400) without engaging the inner and outer housings' engaging elements
(426, 411) a
sufficient period of time (e.g., 1 - 15 seconds or more) and/or for a desired
amount of rotation
(e.g., 360 to 3,600 or more degrees) in the same or different directions.
Fig. 8C shows an exploded cross-section view of the components depicted in
Fig. 8A. In
this embodiment (400), a tapered, downwardly extending seal element (408) is
disposed on the
bottom surface of the component forming the matrix well (403) in the outer
housing (401).
This seal (408) has a sealing surface 409 that is designed to seal against the
sealing surface
(423) of the tapered flange of the retaining element (422) of the inner
housing (420). As in the
embodiment depicted in Figure 7, the embodiment depicted in Figure 8 is
tapered so as to allow
the inner housing to be readily assembled with the outer housing (401), e.g...
by application of
sufficient pressure to the parts to cause the pliable, resilient outer housing
to expand
sufficiently to allow the inner housing (420) to be inserted into the outer
housing's main cavity
(404) to the point where the bearing surface (424) of the inner housing's
retaining element
(422) passes beyond the outer housing's inner housing retaining element (406),
at which point
the outer housing (401) contracts and the bearing surfaces (424, 410) of the
inner and outer
housings' retaining elements (422, 406) come into contact so as to prevent the
inner housing
(420) from being pulled out of the outer housing's main cavity (404) and to
provide a smooth
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interface that allows easy, low friction rotation between the inner and outer
housings (420,
401) if and when desired.
As will be appreciated, and as shown in Figs. 8C-8E, the compressible
cleansing matrix
(405) is inserted into the matrix well (404) during manufacture. The matrix
(405) can be
impregnated with a cleansing reagent (e.g., silver ions), and in preferred
embodiments, a liquid
disinfectant such as a 70% IPA solution. The bearing surface (424) of the
outer housing
retaining element (422), here also a tapered flange molded as part of the
inner housing (420)
during manufacture, is designed to ride on the complementary bearing surfaces
(410) disposed
on the inner surface of the outer housing's main cavity (404). The inner
housing retaining
elements (411) of the outer housing (401) provide for retention of the inner
housing (420) in
the outer housing's main cavity (404) after the inner housing assembled into a
functional
subassembly with the outer housing during manufacture. For example, the inner
housing may
be urged into the outer housing with sufficient force to join them into a
functional subassembly
ready for insertion of compressible cleansing matrix 405) followed by
instillation of a liquid
disinfectant (e.g., a 70% IPA solution), sealing, packaging, and
sterilization. The inner housing
engaging elements (411) present on the inner surface of the outer housing's
sidewall (402)
allow the outer housing (401) to engage outer housing engaging elements (426)
on the adjacent
outer surface of the inner housing (420).
Fig. 8D, the cross section view shows the components of the device of the
invention
(outer housing (401), compressible cleansing matrix (405), and inner housing
(420)) assembled
into a functional capping and cleansing device (400) ready for attachment to
the threaded
region of the valve portion (105) of the NC depicted in Fig. 8A. When the
device (400) is
attached to an NC (100), the NC contacting surface of the matrix (405)
contacts the valve surface
(110) of the NC, allowing that surface to be cleansed by a user rotating the
device (400) in
relation to the NC. Fig. 8E is a cross section showing the capping and
cleansing device (400) of
the invention screwed onto the NC, which results compression of the
compressible cleansing
matrix (405) against the NC's valve surface (110).
Figure 9 (Figs. 9A-9E) shows five different views of another representative
capping and
cleansing device of the invention. This embodiment is similar to that depicted
in Figure 8 (Figs.
8A-8E), the difference being that in the embodiment shown in Figure 9 the
outer housing (501)
has a different outer configuration than the embodiment depicted in Figure 8.
Here, the
sidewall (502) forming the structural portion of the device (500) has a step
in it, giving it a
layered, "wedding cake" appearance in profile. To make the device (500) easy
for a user to
grasp, a series of exterior ribs (535) are provided on the upper portion of
the outer housing's
exterior.
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Specifically, Figure 9 (Figs. 9A-9E) shows five different views of another
representative
capping and cleansing device of the invention (500) in which a user engages
the inner and outer
housings (520, 501) by squeezing (or applying pressure using two or more
fingers) the outer
housing (501), causing it to deform slightly and move inner housing engaging
elements (511)
present on the inner surface of the outer housing's sidewall so that one or
more them (typically
on opposite sides of the outer housing (501)) engage outer housing engaging
elements (526)
present on the exterior surface of the inner housing (520) below the inner
housing retaining
element (522) on the outer surface of inner housing's sidewall (521). The top
of the outer
housing (509) integrates with the outer housing's sidewall (502). Fig. 9D
shows an exploded
perspective view of the device (outer housing (501), compressible cleansing
matrix (505), and
inner housing (520)) and an NC (100) to which the device (SOO) is to be
connected (see Figs. 9B,
9C). The NC (100) has threaded valve region (105) that includes a collar (101)
below its
threaded portion (102). The valve surface (110) is disposed on top of the
threaded valve region
(105). In Figs. 9A-9E, the valve of the NC (100) is not depicted.
Fig. 9A shows a perspective view of the assembled device (500) depicted in
Fig. 9D
secured to the threaded region of the valve portion (105) of the NC (100)
depicted in Fig. 9A.
Preferably, the plastic used to injection mold the outer housing (501) of the
device (500) shown
in this embodiment is softer than the plastic used to mold the inner housing
(502). Preferably,
the plastic used to form the outer housing is sufficiently pliable to allow it
to be squeezed by a
user to allow engagement of between the inner and outer housings' engaging
elements (526,
511) for purposes of attaching and removing the device (SOO) from the NC (100)
but resilient
enough to allow the outer housing (501) to return to its original shape and
thus allow the inner
and outer housings' engaging elements (526, 511) to become disengaged. This
allows a user to
rotate the outer housing (501) and matrix 505) in relation to the NC (100) in
order to cleanse its
valve surface (110) when a cleansing operation is performed, for example, by
rotating the
device (SOO) without engaging the inner and outer housings' engaging elements
(526, 511) a
sufficient period of time (e.g., 1 - 15 seconds or more) and/or for a desired
amount of rotation
(e.g., 360 to 3,600 or more degrees) in the same or different directions.
Fig. 9D shows an exploded cross-section view of the components depicted in
Figs. 9A-9C.
In this embodiment (500), a tapered, downwardly extending seal element (508)
is disposed on
the bottom surface of the component forming the matrix well (503) in the outer
housing (501).
This seal (508) has a sealing surface 509 that is designed to seal against the
sealing surface
(523) of the tapered flange of the retaining element (522) of the inner
housing (520). As in the
embodiments depicted in Figures 7 and 8, the embodiment depicted in Figure 9
is tapered so as
to allow the inner housing to be readily assembled with the outer housing
(501), e.g., by
application of sufficient pressure to the parts to cause the pliable,
resilient outer housing to
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expand sufficiently to allow the inner housing (520) to be inserted into the
outer housing's main
cavity (504) to the point where the bearing surface (524) of the inner
housing's retaining
element (522) passes beyond the outer housing's inner housing retaining
element (506), at
which point the outer housing (401) contracts and the bearing surfaces (524,
510) of the inner
and outer housings' retaining elements (522, 506) come into contact so as to
prevent the inner
housing (520) from being pulled out of the outer housing's main cavity (504)
and to provide a
smooth interface that allows easy, low friction rotation between the inner and
outer housings
(520, 501) if and when desired.
As will be appreciated, and as shown in Figs. 9B-9E, the compressible
cleansing matrix
(505) is inserted into the matrix well (504) during manufacture. The matrix
(505) can be
impregnated with a cleansing reagent (e.g., silver ions), and in preferred
embodiments, a liquid
disinfectant such as a 70% IPA solution. The bearing surface (524) of the
outer housing
retaining element (522), here also a tapered flange molded as part of the
inner housing (520)
during manufacture, is designed to ride on the complementary bearing surfaces
(510) disposed
on the inner surface of the outer housing's main cavity (504). The inner
housing retaining
elements (511) of the outer housing (501) provide for retention of the inner
housing (520) in
the outer housing's main cavity (504) after the inner housing assembled into a
functional
subassembly with the outer housing during manufacture. For example, the inner
housing may
be urged into the outer housing with sufficient force to join them into a
functional subassembly
ready for insertion of compressible cleansing matrix (505) followed by
instillation of a liquid
disinfectant (e.g., a 70% IPA solution), sealing, packaging, and
sterilization. The inner housing
engaging elements (511) present on the inner surface of the outer housing's
sidewall (502)
allow the outer housing (501) to engage outer housing engaging elements (526)
on the adjacent
outer surface of the inner housing (520).
Fig. 9D, the cross section view shows the components of the device of the
invention
(outer housing (501), compressible cleansing matrix (505), and inner housing
(520)) assembled
into a functional capping and cleansing device (500) ready for attachment to
the threaded
region of the valve portion (105) of the NC. When the device (500) is attached
to an NC (100),
the NC contacting surface of the matrix (505) contacts the valve surface (110)
of the NC,
allowing that surface to be cleansed by a user rotating the device (500) in
relation to the NC.
Fig. 8E is a cross section showing the capping and cleansing device (500) of
the invention
screwed onto the NC, which results compression of the compressible cleansing
matrix (505)
against the NC's valve surface (110).
Figure 10 shows three different cut-away views of another representative
capping and
cleansing device (600) of the invention in which the outer housing (601) is
pushed upward by
the compressible cleansing matrix (605) when the device (600) is screwed onto
the threaded
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valve region (105) of a needlefree connector (100). That upward movement
places the outer
housing (601) in a neutral position where the engaging elements (611, 626) of
the outer and
inner housings (601, 620) are disengaged, allowing the outer housing (601) to
be rotated in
relation to the inner housing (620). Figs. 10B and 10C show the device (600)
secured to the
threaded region of the valve portion (105) of an NC, while Fig. 10A shows the
device (600)
disconnected from the NC (100). Fig. 1013 shows the outer housing of the
device in a neutral
position (the engaging elements of the inner and outer housings are not
engaged), from which a
user could rotate the outer housing (and compressible cleansing matrix) in
relation to the inner
housing and NC, to which the inner housing is secured. As will be appreciated,
the compressible
cleansing matrix (605) can serve as a spring or biasing element that, in the
absence of a
sufficient counteracting downward force, pushes the outer housing (601) up in
relation to the
inner housing (620), allowing a user to rotate the outer housing (and
compressible cleansing
matrix) in relation to the inner housing (620) and NC if and when desired.
Absent such rotation,
while connected to the NC the capping and cleansing device of the invention
(600) serves as a
cap to protect the threaded valve region (105) of the NC from environmental
contamination,
including microbial contamination. Fig. 10C depicts the device (600) when the
engaging
elements (626, 611) of the inner and outer housings (620, 601) are engaged,
allowing the device
to be screwed onto or off of the NC (100).
In the embodiment depicted in Figure 10, the device (600) also includes a seal
(630)
disposed on the outer surface of the inner housing (620). The purpose of this
seal is to prevent
rapid loss of liquid cleansing reagents from the device once it has been
attached to an NC, as it is
preferred that a device according the invention be capable of remaining
attached to an NC for up
to 7 or more days.
As will be appreciated, in Figs. 7-10, the lower surfaces (340, 440, 540, 640)
of sidewall
of outer housing (301, 401, 501, 601) are surfaces adapted to receive a lid or
seal (not shown)
to seal the interior spaces of the devices (300, 400, 500, 600) from the
external environment
This not only allows retention of cleansing reagents in the compressible
cleansing matrices
(320, 420, 520, 620) until the particular is used to cap and/or cleanse a
needlefree connector,
but also to maintain the device's sterility.
Unless the context clearly requires otherwise, throughout the description
above and the
appended claims, the words "comprise," "comprising," and the like are to be
construed in an
inclusive sense as opposed to an exclusive or exhaustive sense; that is to
say, in a sense of
"including, but not limited to." Words using the singular or plural number
also include the
plural or singular number, respectively. Additionally, the words "herein,"
"hereunder," "above,"
"below," and words of similar import refer to this application as a whole and
not to any
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particular portions of this application. When the word "or" is used in
reference to a list of two
or more items, that word covers all of the following interpretations of the
word: any of the items
in the list, all of the items in the list, and any combination of the items in
the list.
The foregoing description, for purpose of explanation, has been described with
reference to specific embodiments. However, the illustrative discussions above
are not
intended to be exhaustive or to limit the invention to the precise forms
disclosed. Many
modifications and variations are possible in view of the above descriptions.
The embodiments
were chosen and described in order to best explain the principles of the
invention and its
practical applications to thereby enable others skilled in the art to best
utilize the invention and
various embodiments with various modifications as are suited to the particular
use
contemplated. As such, the invention extends to all functionally equivalent
structures, methods,
and uses, such as are within the scope of the appended claims, and it is
intended that the
invention be limited only to the extent required by the applicable rules of
law.
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