Note: Descriptions are shown in the official language in which they were submitted.
1
CONTINUOUS ANESTHESIA NERVE CONDUCTION APPARATUS,
SYSTEM AND METHOD THEREOF
[0001] [Intentionally left blank].
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The invention generally relates to a continuous anesthesia
nerve conduction
apparatus, system and method thereof, and more particularly to a method and
system for
use in administering a continuous flow or intermittent bolus of anesthetic
agent to
facilitate a continuous or prolonged nerve block.
Discussion of the Related Art
[0003] Currently, regional anesthesia techniques have been employed
to selectively
anesthetize a nerve or groups of nerves to provide pain relief to patients
following a
medical-surgical procedure or trauma. Anesthetic agents, such as local
anesthetic
medication, are administered in close proximity to nerve(s) that innervate the
affected
region of the body. These nerves are located deep within the tissues and a
hollow bore
hypodermic needle is used to deliver the anesthetic medication to the
nerve(s).
[0004] In continuous regional anesthetic procedures, in lieu of a
needle, a catheter
and needle are inserted adjacent to the nerve(s). The needle is removed after
the catheter
placement, and the catheter may be left in position for several days so that
anesthetic
medication can be repeatedly or continuously delivered to the targeted
nerve(s). These
nerve blocks are only efficacious if the anesthetic medication can be
delivered consistently
in close enough proximity to the nerve(s) so as to impart its action on the
nerve(s).
[0005] U.S. Pat. No. 5,976,110 discloses an epidural needle that
can be coupled to a
nerve stimulator. The nerve stimulator is configured to provide an electrical
current that
activates the targeted nerve(s) as the needle gets into close proximity of the
nerve(s). An
epidural catheter is inserted through the lumen of the epidural needle and
advanced until
the distal tip extends several centimeters past the distal tip of the needle.
The epidural
Date
2
catheter is placed without any visualization aid and is assumed to be in close
enough
proximity to the targeted nerve due to the needle tip position.
[0006] U.S. Pat. No. 6,456,874 discloses an epidural catheter
configured to emit an
electrical impulse. Placement of the catheter tip and confirmation of the
catheter tip
placement is obtained by stimulating the targeted nerve(s) via the nerve
stimulator.
[0007] In addition to the use of peripheral nerve stimulation for
nerve localization,
ultrasound imaging has become a common method to position needles and
catheters in
close proximity to nerve(s).
[0008] The related art has a number of disadvantages. The ultrasound
probe is best
managed by the operator of the needle and/or catheter. As such, to maintain
real-time
imaging, one of the operator's hands needs to be occupied handling the
ultrasound
transducer. However, the procedure is difficult with the related art devices
as both hands
are required for advancing a catheter through the needle. Therefore, during
this procedure
the ultrasound probe must be put down and the visualization at that point is
lost.
[0009] Alternatively, another clinician is required or some sort of
mechanical
holding means may be utilized. These alternatives both have disadvantages. The
ultrasound image is a two-dimensional image with an image plane of typically
less than
one millimeter. The mechanical holding devices, i.e., an articulating probe
holder often is
not effective because patient movement can cause the image to distort or
deviate, thereby
preventing reliable real-time imaging of the catheter exiting the needle and
also preventing
visual confirmation of the position of the catheter tip. Moreover, the related
art catheter
devices frequently employ Touhy tipped needles that tend to cause the catheter
to curve
away from the tip of the needle and out of the two-dimensional visualization
plane as the
catheter exits the needle. Therefore, images of the needle with the catheter
exiting the
needle are not typically obtained and the relationship to the targeted
nerve(s) is not
conclusively obtained.
[0010] Another disadvantage of the related art is the need for two
hands to manage
the catheter advancement, as both hands require sterile gloves and sterile
procedural
adherence. Thus, the ultrasound device will need to be sterile, which requires
additional
setup such as sterile sleeves for the ultrasound probe, sterile ultrasound
gel, extensive
draping, and additional personnel. This additional setup adds to the
complexity,
inefficiency, timeliness, and cost of clinicians performing this technique.
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[0011] The related art catheters themselves also have disadvantages.
For example,
in order for the needle to be withdrawn while trying to maintain the catheter
in place, the
catheter needs to be about twice the length of the needle. This added length
makes the
catheter unwieldy, expensive, and difficult to use. The catheter also requires
a lubricious
exterior so that it will easily slide through the needle. The lubricious
exterior of the
catheter makes it difficult to adhere to the skin of the patient, which leads
to easy
dislodgement from its position adjacent to the nerve(s).
[0012] In addition, passing the catheter through the lumen of a large
bore needle, the
catheter's diameter is such that it is smaller than that of the puncture made
by the needle
through the tissue. The catheter diameter size being smaller than the needle
can lead to
leakage of medication at the insertion site during medication infusion,
increasing the
chance of catheter dislodgement.
[0013] There is a need for an improved continuous anesthesia nerve
conduction
apparatus, system and method that substantially obviates one or more of the
problems due
to limitations and disadvantages of the related art.
SUMMARY OF THE INVENTION
[0014] Accordingly, the invention is directed to continuous anesthesia
nerve
conduction apparatus, system and method that substantially obviates one or
more of the
problems due to limitations and disadvantages of the related art.
[0015] An advantage of the invention is that the procedure may be
performed by one
proficient in the art in approximately the same time or less than it takes to
perform a
single-injection nerve block with a needle alone. In most cases, the procedure
may be
performed in less than approximately ten minutes.
[0016] Another advantage of the invention is that the procedure does
not require a
full sterile setup, thereby reducing the time of the procedure.
[0017] Still another advantage of the invention is to provide an
apparatus and
method for performing continuous nerve blocks under real-time ultrasound
guidance that
may be performed with a single hand by one operator.
[0018] Yet another advantage of the invention is to provide an
apparatus and method
that allows for easy handling with secure fixation to prevent dislodgement and
minimize
leakage during infusion.
Date recue / Date received 2021-12-07
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[0019] Still yet another advantage is to provide an apparatus and
method that allows
for a single operator to easily and efficiently place a continuous nerve
conduction catheter
while simultaneously visualizing the catheter placement under ultrasound
guidance, e.g.,
with markings or markers as described herein.
[0020] Still another advantage is to provide an apparatus and method
that allows for
peripheral nerve stimulation capability to be performed simultaneously with
visualization
and with one handed operation.
[0021] Another advantage is to provide peripheral nerve stimulation
emitting from a
needle and/or the catheter. The catheter stimulation may be used for secondary
confirmation, if needed. The nerve stimulation can also be utilized via a
single electrical
connection at or near a hub of the catheter.
[0022] Still another advantage is to provide an apparatus and method
that permits a
fast, cost efficient, and minor labor intensive process, thereby making
continuous nerve
conduction pain relief accessible for more patients.
[0023] Yet another advantage is to provide a catheter with a lateral
port configured
to minimize occlusion rate when compared to a catheter with only a distal
opening.
[0024] Still another advantage is to provide a catheter with a
preformed resilient
distal portion to allow the distal portion of the catheter to be positioned at
least partially
around a nerve, thereby peimitting delivery of a pharmacological agent more
effectively
around the entire nerve as compared to infusion from a straight catheter that
is positioned
at a single point. In a preferred embodiment, at least one lateral port is
positioned near or
on an apex of a curved portion of the catheter.
[0025] Yet another advantage is to provide a catheter with a thickened
or roughened
proximal segment of catheter, thereby minimizing leakage of infused medication
by
wedging the catheter into the skin opening at the insertion site. Leakage of
medication
tends to loosen the dressing and increase the chance of accidental
dislodgement.
[0026] Still yet another advantage is to stimulate a needle while
using the catheter as
the insulator. This permits a single attachment point for the nerve stimulator
while
reducing procedural steps and also simplifies manufacturing by eliminating the
redundant
insulating coating for the stimulating needle.
[0027] Yet still another advantage is to provide a guidewire for
catheter positioning.
The guidewire may include a pre-shaped distal tip configure to allow a
catheter to track
this geometry. Typically, a catheter does not readily move into the pre-
determined
Date recue / Date received 2021-12-07
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position because of a lack of space caused by tissue surrounding the nerve(s)
and utilizing
a guidewire can eliminate this problem. In addition, a directional guidewire
may be
utilized. The directional guidewire is known in the art and may be smaller and
stiffer
which permits easier positioning around the nerve(s) in a curved orientation
and would
then allow for the catheter to follow the tract of the guidewire. Moreover, an
integrated
guidewire with a needle may be utilized. This type of configuration allows for
single
handed deployment of guidewire by advancing the tab on the needle hub, also
reducing
procedural steps by not having to detach the syringe before advancing
guidewire. This can
also be a methodology differentiation.
[0028] Additional features and advantages of the invention will be set
forth in the
description which follows, and in part will be apparent from the description,
or may be
learned by practice of the invention. The objectives and other advantages of
the invention
will be realized and attained by the structure particularly pointed out in the
written
description and claims hereof, as well as the appended drawings.
[0029] To achieve these and other advantages and in accordance with
the purpose of
the present invention, as embodied and broadly described, the apparatus
includes a sheath,
also referred to as a catheter having a proximal end, a distal end and at
least one lumen
extending from the proximal end to the distal end. In one embodiment, the
sheath can
include an embedded conductive element, e.g., wire, for transmitting an
electrical signal
from a proximal portion of the sheath to a distal portion of the sheath. A
cannula, e.g.,
needle or introducer, is arranged in at least one lumen of the sheath and
sized such that a
distal end portion extends past a distal end portion of the sheath. The
cannula can be
electrically coupled to at least a portion of the embedded conductive element
and is
configured to provide nerve stimulation.
[0030] In another aspect of the invention, a method for administering
a continuous
flow or intermittent bolus of anesthetic agent to facilitate a continuous or
prolonged nerve
block includes providing a sheath having a lumen extending from a proximal end
to a
distal end. The sheath includes an embedded conductive element for
transmitting an
electrical signal from a proximal portion of the sheath to a distal portion of
the sheath. In
another embodiment, the sheath provides for insulation of the electrical
signal along the
shaft of the cannula.
[0031] The method further includes providing a cannula into at least
one lumen of
the sheath. The method further includes connecting a syringe configured to
administer a
Date recue / Date received 2021-12-07
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pharmacological agent to the proximal end of the cannula and coupling an
electrical signal
generator to the embedded conductive element or the proximal portion of the
needle.
Next, the cannula and sheath are inserted simultaneously into the patient as a
single unit.
The method includes locating at least one nerve of the patient with at least
one of an
electric signal generated from the electrical signal generator and/or an
active imaging
device. Next, upon location of the nerve, a pharmacological agent is
administered to the
nerve after which advancing and positioning the sheath off of the cannula with
a single
hand of a single user. If necessary, a guidewire can be deployed to direct the
catheter into
a curved position around the nerve(s). Alternatively, the catheter has a
preformed memory
shape and upon removal of the cannula, the sheath curves to the preformed
memory shape.
[0032] Yet another embodiment of the invention is directed towards a
kit, e.g., a
medical package. The kit includes an apparatus for administering a continuous
flow or
intermittent bolus of anesthetic agent to facilitate a continuous or prolonged
nerve block
and directions for use. The kit may also optionally include a pump for
administering a
pharmacological agent, e.g., a disposable infusion pump.
[0033] Yet another embodiment of the invention is directed towards a
kit, wherein
the kit includes sterilized and recycled apparatuses, such as a recycled pump,
e.g., infusion
pump.
[0034] Yet another embodiment of the invention is directed to a method
of
introducing fluid to a nerve or nerve bundle of a patient. The method includes
the steps of
providing an introducer through a lumen of the catheter such that the
introducer protrudes
out the distal tip of the catheter. The method also includes piercing the skin
of the patient
with the introducer and catheter and advancing the introducer and catheter
through the
patient's tissue to a nerve bundle. Upon location of the nerve via imaging
and/or electrical
stimulation removing the introducer from the catheter. The distal end portion
of the
catheter is now located in proximity of the nerve bundle and fluid is
introduced to the
nerve bundle through the catheter, e.g., a nerve block.
[0035] Yet another embodiment of the invention is directed to a system
for delivery
of a fluid to a nerve bundle of a patient. The system includes a fluid pump, a
length of
tubing securable to said pump, an introducer, and a catheter. The introducer
fits within the
catheter. The catheter, pump, tubing, and introducer are provided together as
a kit. Each
component of the kit is sterilized.
Date recue / Date received 2021-12-07
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[0036] Yet another embodiment of the invention is directed to a device
for
dispensing fluid to a patient. The device includes a catheter and an
introducer. The
introducer fits within a lumen of the catheter and is utilized as a system for
insertion into
the patient. The catheter is configured to be connected to a pump. The pump is
compact
and portable and configured for dispensing a liquid under pressure at a
substantially
constant flow rate.
[0037] In one embodiment, the pump includes an elongated,
substantially cylindrical
support member, an elongated elastic sleeve device mounted on and sealingly
secured at
fixed spaced longitudinal positions on said support member for defining a
pressure
reservoir for holding a liquid in a pressurized state for dispensing
therefrom. The pump
also includes a substantially spherical rigid housing formed of like half-
shells hinged
together for removably containing a support member and a pressure reservoir
for enabling
said pressure reservoir to expand naturally and for confining said reservoir
to fill
concentrically about said support member. The pump includes an inlet device
for
introducing a liquid into said elastic pressure reservoir and an outlet device
for dispensing
liquid from said pressure reservoir to a selected site.
[0038] It is to be understood that both the foregoing general
description and the
following detailed description are exemplary and explanatory, and are intended
to provide
further explanation of the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The accompanying drawings, which are included to provide a
further
understanding of the invention and are incorporated in and constitute a part
of this
specification, illustrate embodiments of the invention and together with the
description
serve to explain the principles of the invention.
[0040] In the drawings:
[0041] FIG. 1 illustrates an operational systematic view of a
continuous anesthesia
nerve conduction system according to an embodiment of the invention;
[0042] FIG. 2A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention;
[0043] FIG. 2B illustrates a cross-sectional view of the continuous
anesthesia nerve
conduction apparatus shown in FIG. 2A;
Date recue / Date received 2021-12-07
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[0044] FIG. 3A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention;
[0045] FIG. 3B illustrates a cross-sectional view of the continuous
anesthesia nerve
conduction apparatus shown in FIG. 3A;
[0046] FIG. 3C illustrates an enlarged view of the distal section of
the conduction
apparatus according to FIG. 3A;
[0047] FIG. 4 illustrates an enlarged view of a distal section of a
conduction
apparatus according to another embodiment of the invention;
[0048] FIG. 5 illustrates an enlarged view of a distal section of a
conduction
apparatus according to another embodiment of the invention;
[0049] FIG. 6A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention;
[0050] FIG. 6B illustrates an enlarged view of a distal portion of the
continuous
anesthesia nerve conduction apparatus of FIG. 6A in various configurations;
[0051] FIG. 7 illustrates an infusion pump;
[0052] FIG. 8 illustrates a cross-sectional view of the infusion pump
of FIG. 7;
[0053] FIG. 9 illustrates an infusion pump;
[0054] FIG. 10 illustrates a cross-sectional view of the infusion pump
of FIG. 9;
[0055] FIG. 11 illustrates an infusion pump;
[0056] FIG. 12 illustrates a top view of the infusion pump of FIG. 11,
without the
cover;
[0057] FIG. 13 illustrates a cross-sectional view of an infusion pump
in a collapsed
configuration;
[0058] FIG. 14 illustrates a cross-sectional view of the infusion pump
of FIG. 13 in
the inflated configuration;
[0059] FIG. 15A illustrates a distal portion of a catheter according
to another
embodiment of the invention;
[0060] FIG. 15B illustrates a distal portion of a catheter according
to another
embodiment of the invention;
[0061] FIG. 16 illustrates a single handed catheter advancing device
according to
another embodiment of the invention;
[0062] FIG.17A illustrates a single handed catheter advancing device
according to
another embodiment;
Date recue / Date received 2021-12-07
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[0063] FIG. 17B illustrates a perspective view of the single handed
catheter
advancing device of FIG. 17A;
[0064] FIG. 17C illustrates a perspective view of a single handed
catheter advancing
device illustrated in FIG. 17A with a catheter;
[0065] FIG. 18 illustrates the single handed catheter advancing device
of FIG. 17C
in use;
[0066] FIG. 19A illustrates an embodiment of a solid introducer
according to
another embodiment of the invention;
[0067] FIG. 19B illustrates a continuous anesthesia nerve conduction
apparatus
including solid introducer of FIG. 19A in a catheter according to another
embodiment of
the invention;
[0068] FIG. 20 illustrates a continuous anesthesia nerve conduction
apparatus
including a hollow introducer in a catheter according to another embodiment of
the
invention;
[0069] FIG. 21 illustrates an embodiment of a guidewire according to
another
embodiment of the invention;
[0070] FIG. 22A illustrates a continuous anesthesia nerve conduction
apparatus
including a hollow introducer in a catheter with a sleeve according to another
embodiment
of the invention;
[0071] FIG. 22B illustrates a continuous anesthesia nerve conduction
apparatus
including a guidewire in a catheter with a sleeve according to another
embodiment of the
invention;
[0072] FIG. 23 illustrates a continuous anesthesia nerve conduction
apparatus
according to another embodiment of the invention;
[0073] FIG. 24 illustrates an insert for connection of an electrical
nerve stimulator to
a cannula according to another embodiment of the invention;
[0074] FIG. 25A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention in first
orientation;
[0075] FIG. 25B illustrates the continuous anesthesia nerve conduction
apparatus of
FIG. 25A in a second orientation;
[0076] FIG. 25C illustrates a guidewire according to another
embodiment of the
invention;
Date recue / Date received 2021-12-07
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[0077] FIG. 25D illustrates a guidewire according to another
embodiment of the
invention;
[0078] FIG. 26A illustrates a continuous anesthesia nerve conduction
apparatus
according to another embodiment of the invention;
[0079] FIG. 26B illustrates a cross-sectional view of a distal portion
of the
continuous anesthesia nerve conduction apparatus according to FIG. 26A;
[0080] FIG. 27A illustrates a continuous anesthesia nerve conduction
apparatus
according to another embodiment of the invention;
[0081] FIG. 27B illustrates a cross-sectional view of a distal portion
of the
continuous anesthesia nerve conduction apparatus according to FIG. 27A;
[0082] FIG. 28A illustrates a distal portion of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention;
[0083] FIG. 28B illustrates a distal portion of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention;
[0084] FIG. 29A illustrates an exemplary view of an apparatus
according to an
embodiment of the invention;
[0085] FIG. 29B illustrates an exemplary view of a cannula according
to the
apparatus of FIG. 29A;
[0086] FIG. 29C illustrates an exemplary view of a catheter according
to the
apparatus of FIG. 29A;
[0087] FIG. 29D illustrates an exemplary view of a catheter according
to another
embodiment of the invention;
[0088] FIG. 29E illustrates an exemplary view of a catheter according
to another
embodiment of the invention;
[0089] FIG. 30A illustrates a perspective view of a cannula according
to another
embodiment of the invention;
[0090] FIG. 30B illustrates a top-down view of the cannula according
to FIG. 30A;
[0091] FIG. 30C illustrates an enlarged view of a distal end portion
of the cannula
according to FIG. 30A;
[0092] FIG. 31A illustrates a cross-sectional view of a cannula
according to another
embodiment of the invention;
[0093] FIG. 31B illustrates a proximal end view of the cannula of FIG.
31A;
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11
[0094] FIG. 31C illustrates an exploded view of a hub portion of the
cannula of FIG.
31A;
[0095] FIG. 32A illustrates an exemplary view of a catheter according
to another
embodiment of the invention;
[0096] FIG. 32B illustrates an enlarged view of section B-B of the
catheter of FIG.
32A;
[0097] FIG. 32C illustrates an enlarged cross-sectional view of a
distal end portion
of the catheter of FIG. 32A;
[0098] FIG. 32D illustrates a proximal end view of the catheter of
FIG. 32A;
[0099] FIG. 32E illustrates an enlarged proximal view of the catheter
of FIG. 32A;
[0100] FIG. 33 illustrates an exemplary view of a catheter according
to another
embodiment of the invention;
[0101] FIG. 34A illustrates a top view of a continuous anesthesia
nerve conduction
apparatus according to another embodiment of the invention;
[0102] FIG. 34B illustrates a bottom view of a continuous anesthesia
nerve
conduction apparatus according to FIG. 34A;
[0103] FIG. 34C illustrates a cross-sectional view of the continuous
anesthesia nerve
conduction apparatus according to FIG. 34A;
[0104] FIG. 35A illustrates a perspective view of an extension tubing
set according
to another embodiment of the invention;
[0105] FIG. 35B illustrates a side view of the extension tubing set of
FIG. 35A;
[0106] FIG. 36A illustrates an enlarged view of a portion of a
continuous anesthesia
nerve conduction apparatus according to another embodiment of the invention;
[0107] FIG. 36B illustrates a graph of an interference fit according
to FIG. 36A;
[0108] FIG. 37A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention;
[0109] FIG. 37B illustrates a catheter according to another embodiment
of the
invention;
[0110] FIG. 37C illustrates an anti-restriction member according to
another
embodiment of the invention;
[0111] FIG. 37D illustrates a catheter according to another embodiment
of the
invention;
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12
[0112] FIG. 37E illustrates a catheter according to another embodiment
of the
invention;
[0113] FIG. 37F illustrates a catheter according to another embodiment
of the
invention;
[0114] FIG. 37G illustrates a catheter according to another embodiment
of the
invention;
[0115] FIG. 38 illustrates a kit according to an another embodiment of
the invention;
[0116] FIG. 39 illustrates exemplary supplies of a single sterile
device package
according to an example of the invention;
[0117] FIG. 40 illustrates the localized sterilization of a patient's
skin according to
an example of the invention;
[0118] FIG. 41 illustrates the anesthetizing of a patient, while
simultaneously
imaging the patient according to an example of the invention;
[0119] FIG. 42 illustrates an operator inserting the needle and
catheter into the
patient according to an example of the invention;
[0120] FIG. 43 illustrates an operator hydrodissecting the tissue of a
patient
according to an example of the invention;
[0121] FIG. 44 illustrates the positioning of the catheter, while
simultaneously
imaging the patient according to an example of the invention;
[0122] FIG. 45 illustrates injecting a pharmacological agent into a
patient through
the catheter according to an example of the invention;
[0123] FIG. 46 illustrates attaching tubing to the catheter hub
according to an
example of the invention; and
[0124] FIG. 47 illustrates the catheter being secured to the patient
according to an
example of the invention.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0125] For the purposes of promoting an understanding of the
principles of the
present disclosure, reference will now be made to the exemplary embodiments
illustrated
in the drawing(s), and specific language will be used to describe the same.
[0126] Appearances of the phrases an "embodiment," an "example," or
similar
language in this specification may, but do not necessarily, refer to the same
embodiment,
to different embodiments, or to one or more of the figures. The features,
functions, and
Date recue / Date received 2021-12-07
13
the like described herein are considered to be able to be combined in whole or
in part with
one another as the claims and/or art may direct, either directly or
indirectly, implicitly or
explicitly.
[0127] As used herein, "comprising," "including," "containing,"
"is," "are,"
"characterized by," and grammatical equivalents thereof are inclusive or open-
ended terms
that do not exclude additional unrecited elements or method steps unless
explicitly stated
otherwise.
[0128] [Intentionally left blank].
[0129] (1) U.S. Pat. No. 5,100,390 by Lubeck, et al., which
discloses a needle
hereafter referred to as a metal cannula is of thin-walled construction and
designed with a
solid noncutting pencil point possessing a tip with an elliptical side port
located not more
than 1 (one) cannula Outer Diameter (0.D.) length from the tip. Via a hollow
internal
channel the axial length of the cannula is capable of guiding an inserted
catheter through
the cannula for projection laterally out of the cannula for subsequent
indwelling placement
of the introduced catheter upon removal of the cannula. The sideport is placed
on the
angled surface of the developing point so that it coincides with the angle of
the pencil
point. The elliptical sideport has a machined and polished rounded internal
edge
intersecting with the external surface. The construction of the cannula
combining a large
diameter with a pencil point and the location of an opening at the tip permits
safe
introduction of a spinal catheter into the sub arachnoid space with minimum
damage to
tissues or membranes by either the cannula or a catheter exiting the sideport.
The cannula
is fitted with an obturator which coincides with the shape of the internal
lumen of the
cannula where the obturator tip curves upward to occlude the opening of the
cannula
sideport. The cannula of the present invention has application to subarachnoid
and
epidural regional anesthesia and pain management procedures. The present
invention is
designed preferably as a large gauge needle (17 to 21 gauge) so that it will
accept insertion
of a large flexible catheter (20 to 22 gauge in diameter) for indwelling
placement.
[0130] (2) U.S. Pat. No. 5,364,373 by Waskonig, et al., which
discloses an epidural
cannula for local anesthesia having a cannula point with an adjacent lateral
opening
parallel to the longitudinal axis of the cannula. The cannula has a cross-
sectional
Date recue I Date received 2021-12-Ut
14
enlargement spaced from the point and having an area directed toward the point
that forms
an angle greater than 30 degrees relative to the longitudinal axis of the
cannula.
[0131] (3) U.S. Pat. No. 5,817,017 by Young, etal., which discloses
catheters and
other medical devices include a non-metallic member having paramagnetic ionic
particles
fixedly incorporated therethrough in order to provide enhanced detectability
when viewed
by magnetic imaging regardless of the orientation of the non-metallic member
in the
magnetic field. Catheters are usually formed from polymeric tubing, and the
paramagnetic
ionic particles are usually formed from paramagnetic ions incorporated with
water or other
proton-donating fluid into carrier particles, such as zeolites, molecular
sieves, clays,
synthetic ion exchange resins, and microcapsules. Catheters and other medical
devices
include a non-metallic member having small iron and/or superparamagnetic
particles
fixedly incorporated therethrough or thereover in order to provide enhanced
detectability
when viewed by magnetic imaging. Catheters are usually formed from polymeric
tubing,
and the iron and/or superparamagnetic particles at or near the surface of the
catheter
interact with the water protons of the surrounding patient's body to provide
image
enhancement regardless of the orientation of the polymeric or other non-
metallic material
in the magnetic field.
[0132] (4) U.S. Pat. No. 5,843,048 by Gross which discloses an
epidural needle
through which an epidural catheter may be threaded for administering liquid
anesthesia
into the epidural space, the needle having a curved distal end, the tip of the
needle distal to
the opening in the needle shaft being substantially planar at an angle of
80°-
100° relative to the curved longitudinal axis of the needle shaft, the
needle tip being
characterized as being faceted so as to retard inadvertent passage of the
needle tip through
the dura mater of a patient while at the same time retaining the sharp cutting
edges
common to a like epidural needle which has not had its tip so treated.
[0133] (5) U.S. Pat. No. 5,871,470 by McWha which discloses a combined
spinal
epidural needle set including an epidural needle with an overall length, an
open distal end
and a proximal end with a hub. The epidural needle has a hollow bore
therethrough
having an inside diameter. The set of the invention includes a spinal needle
with an
overall length greater than the length of the epidural needle, a pointed
distal end, a
proximal end with a hub and a hollow passage therethrough. The spinal needle
has an
outside diameter less than the inside diameter of the bore of the epidural
needle. The
spinal needle is slidably disposed for movement within the epidural needle
between a
Date recue / Date received 2021-12-07
15
position wherein the distal point of the spinal needle is substantially
coincident with the
open distal end of the epidural needle and at least one position wherein the
distal point of
the spinal needle projects beyond the open distal end of the epidural needle.
The hubs of
the epidural needle and the spinal needle each include an adjustable
engagement for
preselecting the position of the distal point of the spinal needle with
respect to the open
distal end of the epidural needle.
[0134] (6) U.S. Pat. No. 8,298,208 by Racz which discloses methods for
installing a
flexible spinal needle assembly and methods of delivering a fluid may include
inserting a
distal end of a flexible spinal needle assembly into a subject and,
thereafter, disposing an
anti-restriction member at least partially within an inner flow path of the
flexible spinal
needle to substantially prevent fluid occlusion caused by bending or kinking
of the flexible
spinal needle.
[0135] (7) U.S. Patent Application Publication No. 2006/0206055 by Ice
which
discloses an epidural injection needle with a larger-gauge proximal shaft that
tapers in
close proximity to a smaller-gauge distal tip. A conventional stylet of
suitable material is
employed to stiffen the needle and to prevent material from entering the
needle during
insertion. Wings can be fitted to facilitate manual guidance of the needle.
The short-
tapered design provides an epidural injection needle having a shaft large and
stiff enough
so that it can be reliably guided to the epidural space but also having a
small tip which
minimizes trauma to blood vessels, nerves, and other tissues that may be
inadvertently
punctured during the procedure. This enables epidural injections to be safer
for patients
than those utilizing commercially available needles or prior-art designs.
[0136] (8) U.S. Patent Application Publication No. 2011/0112511 by
Singer which
discloses a method and apparatus for administering liquid anesthetics around
peripheral
nerves, in order to perform surgery or to relieve post-operative pain. The
apparatus
includes a regional anesthetic needle with an overlying catheter. The needle
is hollow and
has a blunt end so that it does not penetrate or damage a nerve or blood
vessel. A stiff
catheter covers the needle up to a side hole in the needle that allows liquid
anesthetic to be
injected through the needle in a forward direction. The needle can be removed
by leaving
the catheter in place without disturbing the location of the catheter.
[0137] (9) U.S. Patent Application Publication No. 2011/0201930 by
Guzman which
discloses a procedure and kit are provided for performing an ultrasound-guided
transversus abdominis plane (TAP) procedure. The patient's abdomen is scanned
with an
Date recue / Date received 2021-12-07
16
ultrasound probe to identify and mark the external oblique, internal oblique,
and TAP. An
introducer sheath is placed over a fluid delivery needle such that the distal
end of the
needle extends beyond the distal end of the sheath, the needle having
echogenic properties
for ultrasound imaging. The needle and sheath are ultrasonically guided into
the TAP. A
local anesthetic or saline/anesthetic combination is injected through the
needle to create a
liquid pool in the TAP. The needle is removed from the sheath while
maintaining the
sheath within the TAP and a catheter is subsequently advanced through the
sheath and into
the pooled liquid in the TAP. The sheath is withdrawn while maintaining the
catheter
located within the TAP. A catheter is connected to a source of local
anesthetic for
providing a defined volume of anesthetic to the catheter site at a controlled
delivery rate.
[0138] (10) U.S. Patent Application Publication No. 2012/0059308 by
Hsu which
discloses an anesthetic nerve block catheter and methods of using the
anesthetic nerve
block catheter to perform a nerve block or continuous nerve block procedure
arc disclosed.
[0139] (11) U.S. Patent Application Publication No. 2012/0232389 by
Guzman
which discloses an apparatus for administering certain nerve blocks includes a
sheath
constructed from a flexible ultrasound echogenic material, a more rigid
introducer/dilator
for introducing the sheath into the patient, and an ultrasound echogenic
catheter for
inserting through the sheath once the distal end of the sheath is in place
adjacent the
nerve(s) to be blocked and the introducer/dilator has been withdrawn. The
catheter has
provisions at its proximal end for connecting to a source of local anesthetic.
Methods for
use of this apparatus are also described.
[0140] Aspects of the invention relate to novel medical apparatuses
and methods for
placement of a continuous nerve conduction catheter for prolonged neural
blockage in the
area of providing patients with pain relief The apparatus can be placed with
minimally
involved methodology that requires only a single operator, particularly when
assisted by
ultrasound guidance, allowing for continuous visualization or by other means
known in
the art.
[0141] In one embodiment, the apparatus includes a sheath having a
proximal end, a
distal end and at least one lumen extending from the proximal end to the
distal end. The
terms sheath and catheter are used interchangeably throughout the
specification. The
sheath may also include an embedded conductive element for transmitting an
electrical
signal from a proximal portion of the sheath to a distal portion of the
sheath. The sheath
may be reinforced or not reinforced in any of the embodiments of the
invention. A
Date recue / Date received 2021-12-07
17
cannula or introducer is arranged in at least one lumen of the sheath and has
a distal end
protruding from a distal portion of the sheath. The terms cannula, needle, and
introducer
are used interchangeably throughout the specification. The cannula is
electrically coupled
to at least a portion of the embedded conductive element and may be configured
to provide
nerve stimulation independently or in conjunction with the sheath.
[0142] The cannula may include a sharp tip, a short beveled tip
and/or a bullnose tip
with a lateral port. The cannula may also be a Touhy needle, Crawford needle,
Hustead
needle, Sprotte needle, Whitacrea needle, Quincke needle, or other medical
needles. In a
preferred embodiment, the gauge of the needle is in a range from about 6 to
about 26 and
more preferably the gauge of the needle is in a range from about 18 to about
20. The
cannula may be hollow or solid. The cannula as described with reference to
U.S. Patent
Application Publication No. 2011/0112511, may be used.
[0143] The cannula may also include one or more solid state
sensors, e.g.,
temperature, pressure, and/or flow rate. Multiple sensors may also be used
throughout the
lumen of either the cannula and/or catheter. These sensors may be configured
to
communicate wirelessly via Wi-Fi, Bluctooth, and/or other wireless
communication
protocols as known in the art to a readout or other device (not shown) such as
a controller.
Of course, the sensors may be hardwired to communicate directly with a readout
or other
internal or external device.
[0144] The terms sheath, sleeve, and catheter are used
interchangeably throughout
the specification. The sheath may be constructed as a reinforced catheter with
various
materials. For example, the sheath may include polyesters; polyurethanes;
polyamides;
polyolefins including polyethylene and polypropylene; and any copolymers
thereof. Some
more specific examples of suitable materials include, but are not limited to:
nylon;
polyester elastomer; polyether/block polyamide, such as Pebax, Hytrel, and/or
Arnitel;
polyamid such as Grilamid; flouro-polymer, such as Kynar; polyether ether
ketone
(PEEK); polyethylene (PE); polyurethane; polyolefin copolymer (POC);
tetrafluoroethylenes, such as polytetrafluoroethylene (PTFE). In a preferred
embodiment,
the sheath is reinforced with materials configured to substantially prevent
kinking of the
sheath.
[0145] The catheter may also be constructed, in whole or in part,
utilizing a variety
of degradable materials, polymeric materials, synthetic or natural, and
combinations
Da
18
thereof. Furthermore, the catheter may be composed such that the portion of
the catheter
that enters and remains in the patient is degradable, but the portion that
remains
substantially outside of the patient is not degradable. Furthermore, a break
point may exist
between the two materials to assist in separating the catheter, e.g., leaving
the degradable
portion in the body while the non-degradable is removed. In this type of
arrangement the
patient would not have to return to the physician to remove the catheter.
[01461 Degradable materials include bioabsorable materials, e.g.
such as, polymers
and copolymers composed from varying amounts of one or more of the following
monomer examples, glycolide, d,l-lactide,l-lactide, d-lactide, p-dioxanone
(1,4-dioxane-2-
one), trimethylene carbonate (1,3-dioxane-2-one), E-caprolactone, y-
butyrolactone, 6-
valerolactone, 1,4-dioxepan-2-one, and 1,5-dioxepan-2-one.
[0147] The sheath may also include solid state sensors, e.g.,
temperature, pressure,
and/or flow rate. The sheath may also include a communication means such as
receiver/transceiver for communication via wireless, bluetooth, radio
frequency (RF)
and/or other protocols as known in the art.
[01481 The sheath and cannula may include antibacterial materials
such as coatings
and/or micropatterned surfaces to inhibit or prevent unwanted accumulation of
organic
and/or inorganic matter of biological origin on surfaces. The micropattemed
surfaces for
controlled bioadhesion are described within PCT Application No.
PCT/US10/59246.
The micropattemed
surfaces are also sold under the brand name SharkletTm. In addition, the
coatings may
include broad-spectrum antimicrobial coatings such as silver, nanosilver and
other
antimicrobial coatings as known in the art. In one embodiment, the
antibacterial coatings
for the catheter and/or cannula are described with reference to U.S. Patent
Application
Publication No. 2013/0084319.
[0149] In another embodiment, the invention is directed towards a
method for
administering a continuous flow or intermittent bolus of anesthetic agent to
facilitate a
continuous or prolonged nerve block. The method includes providing a sheath
having a
proximal end, a distal end and at least one lumen extending throughout a
portion of the
sheath. The sheath may include an embedded conductive clement for transmitting
an
electrical signal from a proximal portion of the sheath to a distal portion of
the sheath.
The method includes providing a cannula into at least one lumen of the sheath.
Date
19
[0150] The continuous anesthesia nerve conduction apparatus is
configured to allow
a physician to perform the procedure within approximately ten minutes or less,
and
preferably within approximately five minutes or less. With a minimal sterile
setup, and
easy identification of the targeted nerve(s), positioning the cannula adjacent
to the nerve(s)
permits the sheath positioning with a single hand in one continuous motion.
[0151] There are several advantages of having a catheter and/or needle
that has a
different diameter at a distal region as compared to the body region or even a
proximal
region. A few of these advantages are as follows.
[0152] During a procedure a vital part of positioning a catheter is to
ensure that the
catheter tip is in close proximity to the targeted nerve(s). Identification of
the catheter tip
is conventionally done by some form of echogenic marking. If the marking is
localized
only to the tip, then the marking is very small and is often difficult to
visualize with
ultrasound imaging. If the marking is along the entire length of the catheter,
then the tip is
difficult to distinguish from the catheter shaft. Altering the diameter of the
distal portion
of the catheter or tip portion from the body portion or shaft of the catheter
is a novel and
functional way to identify the catheter tip on ultrasound imaging so the
operator can easily
determine when the catheter tip is properly positioned to increase efficacy
and reduce the
time of the procedure.
[0153] By way of example, the space surrounding a neural structure is
limited and
the pocket created by hydro-dissection is small. A smaller diameter distal
portion or
catheter tip permits the distal portion to more effectively attain the shape
within the
limited space around the nerve(s).
[0154] Some nerve blocks are performed in locations where the space
between the
nerves and the surrounding tissue is very tight. The Thoracic Paravertebral
block is one
such case where the space around the nerve is small and advancing too far
results in
puncturing the lung. By having a smaller diameter tip on the catheter and
needle, the
catheter can be maneuvered more precisely within the confines of the
paravertebral space.
[0155] In a preferred embodiment, a curved needle and/or curved
catheter can be
utilized with the system. The curved needle helps direct the catheter in a
particular
direction. Most nerve block procedures are most effective when the catheter is
positioned
to provide radial spread of local anesthetics. Neural structures are
frequently cylindrical in
shape and by positioning the catheter to cover an area in a range from about
75 degrees to
about 280 degrees surrounding a nerve thereby provides the best radial spread
of the local
Date recue / Date received 2021-12-07
20
anesthetic. A curved needle allows for the hydro-dissection at an angle
different than that
of the insertion angle of the needle and directs the catheter away from a
perpendicular
orientation to the nerve(s). The curvature of the needle is not so great as to
inhibit the
insertion of the needle/catheter unit.
[0156] In one embodiment, the medical apparatus includes a catheter
having a
proximal end, a distal end, a lateral port, a distal end region, proximal end
region, and at
least one lumen extending from the proximal end to the distal end. The distal
end region
includes a first diameter and a proximal end region has a second diameter. The
apparatus
may also include a disposable pump and cannula configured to be arranged in at
least one
lumen. The first diameter may be smaller or greater than the second diameter.
The first
diameter can be configured to taper to the second diameter at a transition
region or point
between the diameters. The taper can be a non-linear taper shape, linear taper
shape and
combination of the same.
[0157] In one embodiment, the distal end region having a different
diameter than
another portion of the catheter can have a total length in a range from about
0.1 cm to
about 5 cm, and preferably, the distal end region has a total length in a
range from about 1
cm to about 1.5 cm. The diameter of the distal end region may be constant or
variable,
e.g., it may include a taper from a proximal end of the distal end region to
the distal end of
the catheter. By way of example, the taper can include a third diameter and a
fourth
diameter. In one embodiment, the fourth diameter is smaller than the third
diameter and
the third diameter is smaller than the first diameter. The diameter of the
first diameter,
second diameter, third diameter, and/or fourth diameter may be in a range from
about 5
gauge to 25 gauge, preferably in a range from about 17 gauge to about 22 gauge
and most
preferably in a range from about 18 gauge to about 20 gauge.
[0158] Any portion of the catheter may include an echogenic material
and/or
radiopaque material as described herein. The distal end region may include a
first material
having a first ultrasound visualization property and the proximal end region
and/or rest of
the catheter may include a second material having a second ultrasound
visualization
property. In one embodiment, the first material and second material are the
same. In
another embodiment, the first material comprises a thermoplastic material only
and the
second material includes a thermoplastic material only. In one embodiment, the
first
thermoplastic material is different than the second thermoplastic material. In
a preferred
embodiment, the distal end region of the catheter and/or cannula is configured
to bend or
Date recue / Date received 2021-12-07
21
curve at angle in range from about 5 degrees to about 175 degrees relative to
the central
axis. In one embodiment, the apparatus may include an electrical connection
element near
a distal portion of the catheter, wherein the electrical connection element is
configured to
be coupled to a nerve stimulator.
[0159] The method further includes connecting a syringe configured
to administer a
pharmacological agent to the distal end of the cannula and coupling an
electrical signal
generator to the embedded conductive element or to the cannula directly. Next,
the
cannula and sheath are inserted simultaneously into the patient. The method
includes
locating at least one nerve of the patient with at least one of an electric
signal generated
from the electrical signal generator or an active imaging device and
administering a
pharmacological agent to the at least one nerve after advancing and
positioning the sheath
off of the cannula with a single hand. If needed, a guidewire is directed
through the lumen
of the cannula to position the sheath in a semi-circumferential near the
nerve(s).
[0160] Yet another embodiment of the invention is directed towards
a kit, e.g., a
medical package. The kit includes an apparatus for administering a continuous
flow or
intermittent bolus of anesthetic agent to facilitate a continuous or prolonged
nerve block
and directions for use. The kit may optionally include a pump for
administering a
pharmacological agent, e.g., a disposable infusion pump. Disposable infusion
pumps are
known in the art such as the ON-Q C-bloc- Continuous Nerve Block System by I-
Flow
Corporation, PainPump 1, PainPump 2, PainPump 2 BlockAid by Stryker
Corporation,
and GoPump or GoBlock by Symbios. In some embodiments, the kit includes
items
that have been sterilized and recycled. These items may include for example,
portions of
the pump and exterior components such as clips and luers. Several
configurations of the
pump may be used, including pumps described in U.S. Patent Nos. 5,284,481;
7,322,961;
5,352,201 and 5,080,652.
[0161] Reference will now be made in detail to an embodiment of the
present
invention, example of which is illustrated in the accompanying drawings.
[0162] FIG. 1 illustrates an operational systematic view of
continuous anesthesia
nerve conduction system according to an embodiment of the invention.
[0163] Referring to FIG. 1, the system is generally depicted as
reference number
100. The system overview 100 includes an exterior portion of a sheath 102. The
sheath
102 is secured to the skin of the patient with securing tab or tabs 103 and
anchored to a
Oak.
22
hub 104. Nerve(s) 106 lying deep in tissue below the exterior surface of the
patient arc
targeted to receive a pharmacological agent, A subcutaneous distal portion of
the sheath
108 is shown positioned in close proximity to the targeted nerve(s) 106, e.g.,
nerves of the
brachial plexus. The sheath 108 may include a side port and markings to aid
with external
visualization, e.g., active or passive visualization. The markings may be
spaced apart to
aid in further visualization and orientation of the side port as shown in
FIGS. 28A and
28B.
[0164] An infusion pump 110 which may be filled with a
pharmacological agent,
e.g., pain medication such as a nerve block, is connected to the apparatus via
connecting
tubing 112, by way of example, with Luer locking connectors to the hub 104.
The pump
110 can include an ON-Q0 C-bloc- Continuous Nerve Block System by I-Flow
Corporation, PainPump 1, PainPump 2, PainPump 2 BlockAid by Stryker
Corporation,
and GoPump or GoBlocke by Symbios. For example, the pump may include a pump
as
described in U.S. Patent Nos. 5,284,481; 7,322,961; 5,352,201 and 5,080,652.
Several different
configurations of the tubing may be used. For example, a coupler may be used
so that the
pharmacological agent in the pump may be directed to multiple locations in the
body. In
addition, multiple catheter units may be used and different configurations of
the catheter
may also be used.
[0165] Several different configurations of the pump 110 may be
used. In a preferred
embodiment, a disposable pump, infusion pump and other inexpensive pumps as
known in
the art is used with a continuous anesthesia nerve conduction apparatus. Such
as an
infusion pump 110 such as that described in -U.S. Patent No. 5,284,481,
FIGS. 7 and 8 illustrate exemplary
embodiments of infuser pumps. The infuser pump, designated generally by the
numeral
710, is collapsible and includes an outer collapsible, substantially non-
stretchable housing
or shell 712, protectively mounted over a combined reservoir and support
assembly
constructed substantially like that set forth in U.S. Pat. Nos. 5,080,652 and
5,105,983.
[0166[ The collapsible housing 712 has a substantially spherical
configuration for
confining and guiding the inflatable reservoir or bladder into a concentric
position around
the central support member, and enabling it to expand naturally in a spherical
configuration as will be described. However, other geometric configurations
are also
Dal
23
possible for the collapsible housing. The collapsible housing 712, as seen in
FIG. 8, has
coaxial openings defined by tubular sleeve extensions 714 and 716 through
which the ends
of a central support member 718 extends.
[0167] An elastic membrane or bladder assembly 720 forming an
inflatable
reservoir, such as described in the aforementioned patents, is mounted on the
cylindrical
support member 718. The bladder assembly 720 may be a single sleeve or
multiple
sleeves. This is preferably with an inner sleeve being a chemically inert
sleeve, and the
outer sleeve or sleeves being highly elastic.
[0168] The central cylindrical support member or mandrel 718 includes
circular
grooves only one of which, 722 is shown, at the ends thereof into which
portions of the
sleeve 720 and housing 712 are biased with a pair of 0-rings, only one of
which, 726, is
shown. The collapsible housing 712 is preferably a non-stretch blow molded
housing of
five to ten mil-inches in thickness and made of a material such as
polyurethane, PVC film,
and/or polyethylene and is transparent. This forms a simple inexpensive
compact unit
with a certain amount of protection for the elastic reservoir.
[0169] Certain applications may require a tougher collapsible housing.
In such
cases, the housing can be transparent, UV stable, flexible and highly
resistant to
puncturing. In this configuration, the housing would be constructed of a
material such as
tough composites in a flexible form such as a fabric, reinforced
thermoplastic, Kevlar
material which includes a para-aramid synthetic fiber, related to other
aramids such as
Nomex and Technora, and combinations of the same.
[0170] The ends of the central support member 718 include reduced
diameter
extension 730 and 732, with bayonette type couplings for releasably coupling
cup-shaped
caps 734 and 736 which extend over and protectively cover the 0-ring
connections or
clamping of the elastic bladder and collapsible housing to the support member.
[0171] The support member 718 has an inlet or fill port 742 on one end
which
communicates with a coaxial passage 744, and a transverse passage 746 in which
is
mounted a check valve 748. The cross bore 746 communicates with passage 744
and inlet
port with the interior of the elastic bladder or sleeve 720 and thus the
interior of the
inflatable reservoir. The check valve is also used and is of a generally
cylindrical outer
shape, with a square bore extending from one end and closed at the other
forming a cup-
shaped structure. The check valve may be constructed of materials known in the
art, e.g.,
an elastomer like silicone, and collapses inward to allow filling and erects
to its normal
Date recue / Date received 2021-12-07
24
configuration to prevent back flow. The square bore configuration of the bore
insures that
it returns to its normal configuration and does not remain collapsed.
[0172] An outlet port through end 732 communicates with a passage
754 that
extends coaxially from the other end of the support member 718, and
communicates with a
cross bore or port 756 with the interior of the elastic bladder or reservoir
720. The port
756 may include a sensor 711 to measure flow rate, pressure, liquid volume,
and
temperature among other characteristics. Multiple sensors may also be used
throughout
the interior. These sensors may be configured to communicate wirelessly via Wi-
Fi,
Bluetooth, and other wireless communication protocols as known in the art to a
readout or
other device (not shown) such as a controller. Of course, the sensors may be
hardwired to
communicate directly with a readout or other internal or external device.
[0173] A tubing set, as shown in FIG. 7 including a tube 752 having
a filter 758 and
a connector 760 at the end, provides a device for connecting and dispensing a
fluid to a
desired location, such as a catheter (FIG. 1) as described herein. The
connector 760 may
be permanently attached to the tube 752, or may be removable. Furthermore, any
suitable
connector may be used, including a luer connector or others as known in the
art.
[0174] The collapsible infuser apparatus of FIGS. 7 and 8 is a
compact and
inexpensive disposable unit. It has a compact configuration, with a collapsed
diameter no
greater than the outer diameter of the caps 734 and 736. For this reason, it
is convenient to
package in a kit as described herein. Optionally, it may be temporarily housed
during use
in a protective hard shell housing.
[0175] In another embodiment, the pump 110 may be the pump
described in U.S.
Patent No. 7,322,961. FIGS 9
and 10 illustrate an infusion pump or apparatus, generally referred to by the
reference
numeral 910. The infusion apparatus 910 is operable to deliver a pressurized
liquid, such
as a pharmacological agent, e.g., pain medication, to a desired site such as a
catheter (FIG.
1). Preferably, the infusion apparatus 910 is relatively inexpensive, portable
and provides
reliable operation throughout its useful life. The infusion apparatus 910 may
be reusable
or may be disposable after a single use.
[0176] The infusion apparatus 910 desirably includes an infusion
pump 912, which
is configured to hold a pressurized supply of a fluid, such as a
pharmacological agent.
Preferably, a supply arrangement 914 includes in substantial part by a length
of medical
tubing 916, is in fluid communication with the infusion pump 912 at a first
end. The
Date.
25
supply arrangement 914 supplies the pressurized fluid to the catheter or other
delivery
device, through an appropriate connection device 918 at a second end. The
medical tubing
916 may be formed of any of a variety of materials suitable for use in medical
applications. Preferably, such materials are constructed form a polymeric
material and
substantially bio and/or chemically inert. Similarly, the connector 918 may be
any
suitable device to permit relatively quick and secure connection between a
pair of medical
devices, such as a luer lock, for example. Other types of suitable connectors
may also be
used.
[0177] In a preferred embodiment, the supply arrangement 914 includes
a filter 920
in serial connection with the medical tubing 916. The filter 920 desirably is
configured to
remove impurities, including air bubbles, from the fluid delivered from the
infusion pump
912. The filter 920 may be any suitable medical filter as known in the art.
[0178] Preferably, the supply arrangement 914 also includes a clamp
922, which is
desirably positioned upstream of the filter 920. The clamp 922, in a closed
position, is
configured to apply a squeezing pressure to the medical tube 916 to close the
lumen
therein and occlude fluid flow beyond the clamp 922. Any suitable type of
medical clamp
may be used.
[0179] With reference to FIG. 10, the infusion pump 912 generally
includes an
elastic sleeve 924 surrounding a support member. Preferably, the support
member 926 is
generally cylindrical in shape; however, other suitable shapes of support
members may
also be used. The elastic sleeve 924 is expandable in a radial direction about
the
cylindrical support member to an expanded condition 924a. In the expanded
condition
924a, the elastic sleeve 924 and the support member cooperate to define a
variable volume
fluid reservoir 928 therebetween.
[0180] Preferably, the infusion pump 912 is configured such that the
reservoir 928
may be filled (also referred to as "loading" the pump 912), from an inlet end
926a of the
support member. Preferably the infusion pump 912 may be manually loaded with a
loading device, such as a syringe. Once the reservoir 928 has been filled with
fluid, the
elastic nature of the sleeve 924 exerts a pressure on the fluid within the
reservoir 928,
permitting the fluid to be delivered to a desired site catheter through the
supply
arrangement 914 and delivery device, e.g., device of FIG. 1.
[0181] The sleeve 924 may include a single layer or multiple layers.
The inner
sleeve 924a may include a bio and/or a chemically inert material to avoid
interaction with
Date recue / Date received 2021-12-07
26
the drug within the infusion pump 912 while an outer sleeve 924b may include a
material
having desirable elastic properties. The combination of the sleeves 924a, 924b
desirably
provide satisfactory elastic properties and desirable chemical properties to
consistently and
safely deliver the pressurized fluid, such as a pain medication. In one
arrangement, the
inner sleeve 924a may include a semi-elastic thermal plastic material. The
outer sleeve
924b may include a natural latex rubber material, which provides desirable
elastic
characteristics. However, other suitable materials may also be used.
[0182] If desired, the infusion pump 912 may also include a
protective, collapsible
housing, or pouch 930 surrounding the elastic sleeve 924. Desirably, the pouch
930 is
relatively inelastic to limit expansion of the sleeve 924. In addition, the
pouch 930
desirably is made from a tougher material than that of the sleeve 924 in order
to protect the
sleeve from punctures, or other damage. In one preferred arrangement, the
pouch 930
includes a pair of flat, sheet-like portions bonded to one another around
their peripheral
edges. Preferably, the portions of the pouch 930 comprise a PVC material,
which are
bonded to one another by Radio Frequency (RF) welding. Such a construction
provides a
suitable, economical means to protect the elastic sleeve 924 from damage.
Other suitable
materials and construction techniques may also be employed.
[0183] Desirably, the elastic sleeve 924 is sealed to the cylindrical
support member
926 at spaced apart locations near each end 926a, 926b of the cylindrical
support 926 by a
pair of seal assemblies 932 (only one shown). The reservoir 928 of the
infusion pump 912
is defined between the pair of seal assemblies 932. If a housing or pouch 930
is provided,
end portions thereof may also be held in place by the seal arrangement 932.
These and
other details of the sealing arrangements 932 are described in greater detail
below.
[0184] Desirably, a cap 934 is attached to each end of the infusion
pump 912.
Preferably, each cap 934 includes a side wall portion which at least partially
covers the
sealing arrangement 932. Such an arrangement serves to inhibit damage to the
sealing
arrangement 932 during normal use of the infusion apparatus 910 and provides
an
aesthetically pleasing outward appearance. Other sealing mechanisms may be
used.
[0185] The cap 934 is removably connectable to the support member 926.
In a
preferred embodiment, the cap 934 is coupled to the support member 926 by a
snap fit
arrangement wherein the cap 934 includes a triangular-shaped cutout 936. The
cutout 936
is sized such that a portion of each side of the triangular-shaped cutout 936
may be
received within an annular recess defined by the cylindrical support member
926.
Date recue / Date received 2021-12-07
27
Desirably, the cap 934 is constructed from a material having sufficient
flexibility such that
the side portions of the cutout 936 may deflect to pass over the end portion
of the support
member 926, which has a larger diameter and is positioned outwardly, along the
support
member 926, from the recess. Any of a variety of common thermoplastic
materials may be
suitable for use in construction of the end cap 934. Other suitable end cap
constructions
may be used, such as a threaded end cap arrangement, plug, and the like.
[0186] The infusion pump 912 also includes an inlet 940 and an outlet
942 in fluid
communication with the reservoir 928. In the illustrated embodiment, the inlet
940 and
outlet 942 are at least partially defined by the support member 926.
Desirably, each of the
inlet and outlet 940, 942 include a longitudinally extending channel 944, 946,
respectively,
which open to opposing end surfaces of the support member 926. In addition,
each of the
inlet and outlet 940, 942 include a radially extending channel 948, 950,
respectively,
which communicate with the longitudinal channels 944, 946 and open from a
portion of
the side wall of the cylindrical member 926 located within the fluid reservoir
928, or the
reservoir wall. A sensor 911 to measure flow rate, pressure, liquid volume,
and
temperature among other characteristics. Multiple sensors may also be used
throughout
the interior of the infusion pump 912. These sensors may be configured to
communicate
wirelessly via Wi-Fi, Bluetooth, and other wireless communication protocols as
known in
the art to a readout or other device (not shown) such as a controller. Of
course, the sensors
may be hardwired to communicate directly with a readout or other internal or
external
device.
[0187] The inlet-defining end 926a of the support member 926 desirably
is
configured to receive a reservoir loading device, such as a syringe, which may
be
interconnected to the support member 926 by a threaded connection, such as a
luer lock
connection, for example. In operation, the loading device introduces fluid
into the fluid
reservoir 928, against the biasing force of the sleeve 924. Desirably, once
the infusion
pump 912 has been loaded with fluid, the inlet end of the support member 926
is closed by
a cap 952. The elasticity of the sleeve 924, once expanded 924a, pressurizes
the fluid
within the reservoir 928.
[0188] Preferably, the inlet 940 includes a one-way valve to inhibit
fluid within the
reservoir 928 from escaping through the inlet 940. The valve includes a valve
member
954 positioned within the radially extending channel 948. The valve member 954
is
desirably cylindrical in shape and includes a recess extending, from an end
surface, along
Date recue / Date received 2021-12-07
28
a longitudinal axis of the valve member 954. Preferably, the recess is
generally square in
cross-section and extends substantially the entire length of the valve member
954, thereby
defining a closed end of the valve member 954 having a thickness approximately
equal to
a thickness of the outer wall portion of the valve member 954.
[0189] When installed in the radially extending channel 948, a portion
of the wall of
the valve member 954 facing the longitudinal channel 944 collapses in response
to fluid
being loaded in the infusion pump 912 through the inlet 940. However, once the
fluid
pressure within the inlet 940 is lower than the pressure within the reservoir
928 (i.e.,
filling of the reservoir 928 has ceased), fluid within the recess urges the
valve member 954
back into its original, cylindrical orientation to inhibit fluid from entering
the longitudinal
channel 944 and, thus, exiting the reservoir 928 through the inlet 940. Other
suitable
valves may also be used as known in the art.
[0190] Desirably, the longitudinal channel 946 of the outlet 942
extends through an
outlet end 926b of the support member 926 and communicates with the medical
tubing
916 of the supply arrangement 914. Desirably, the outlet 942 permits
relatively
unobstructed fluid flow. That is, a one-way valve mechanism is not necessary
or desirable
in connection with the outlet 942. Accordingly, with such an arrangement,
fluid flow from
the reservoir 928 through the outlet 942 is selectively permitted by the clamp
922 of the
supply arrangement 914.
[0191] Optionally, the pump 912 may include a flow restrictor (not
shown)
downstream from the fluid reservoir 928. The flow restrictor is configured to
restrict the
flow rate of fluid exiting the fluid reservoir 928 to a desired level. The
flow restrictor may
comprise a reduced-diameter of the outlet passage 946 (in whole or in part),
the diameter
of the tubing 916 (FIG. 9), or a separate flow restrictor device positioned
downstream
from the fluid reservoir 928. Other suitable arrangements are also possible,
including a
combination of the above-mentioned flow restrictor arrangements.
[0192] The seal arrangement 932 is described in greater detail. The
seal
arrangement 932 desirably includes an annular recess, or groove 958, near an
end of the
support member 926. The recess 958 is defined by an outer surface of the
support member
926 and, preferably, is substantially semi-circular in shape. A generally
annular spring
clip 960 is sized to be positionable onto the support member 926 and,
preferably,
cooperate with the recess 958 to create a seal between the sleeve 924 and the
support
member 926.
Date recue / Date received 2021-12-07
29
[0193] The spring clip 960 is configured to be movable from a
relaxed position, or a
free diameter of the spring clip 960, to a deflected position. In the relaxed
position, an
inner diameter of the spring clip 960 desirably is smaller than a diameter of
the support
member 926 with which the spring clip 960 is positioned. In the deflected
position, the
inner diameter of the spring clip 960, desirably, is large enough to pass over
the elastic
sleeve 924 and cylindrical support member 926 to permit assembly onto the
infusion
pump 912. Once released, the spring clip 960 returns toward the relaxed
position.
Preferably, the support member 926 is sized such that the spring clip 960 is
prevented
from returning to the fully relaxed position. Accordingly, the spring clip 960
exerts a
squeezing force on the elastic sleeve 924 to create a seal between the sleeve
924 and the
cylindrical support member 926 thereby defining an end of the fluid reservoir
928. As
will be appreciated by one of skill in the art, the squeezing force developed
by the spring
clip 960 may be adjusted to a desired level by altering the relative sizes of
the inner
diameter of the spring clip 960 and the outer diameter of the corresponding
portion of the
support member 926, as well as by altering the properties of the spring clip
960 itself, such
as the coil diameter of the spring clip 960, for example.
[0194] Desirably, the elastic sleeve 924 (and pouch 930, if
provided) is biased into
the recess 958 by the spring clip 960. Such an arrangement assists in defining
and
maintaining a proper position of the spring clip 960 relative to the support
member 926.
In addition, the deflection of the sleeve 924 into the recess 958 increases
the effectiveness
of the seal arrangement. Although only the inlet side 926a seal arrangement
932 is shown,
preferably the outlet side 926b is constructed substantially similarly to that
of the inlet side
926a. Preferably, the spring clip 960 is constructed of metal; however, other
suitable
materials such as plastics may also be used.
[0195] In another embodiment, the system may include a pump 110 as
described in
U.S. Patent No. 5,352,201. FIGS 11
and 12 illustrate the infusion pump or apparatus, generally referred to by the
reference
numeral 1010. The infusion apparatus is embodied in a housing having a
generally flat
spiral configuration. However, it may have other outer configurations such as
circular,
semicircular or square. The apparatus includes a main housing having thermally
formed
walls extending upward from a bottom and extending in a radially outward
spiral to a
terminal end such that all the connections are provided. The main housing has
an open top
formed for receiving a generally flat planer cover 1014. The cover 1014 may be
formed
Date recue I Date received 2021-12-Ut
30
with recesses or other structural configurations to enable stacking of a
plurality of the
units.
[0196] The housing is preferably formed of any one of a number of
thermoformable
plastic polymer materials and vacuum formed into its shape or configuration.
Either the
housing 1012 or the cover 1014 or both may be of a transparent material.
Preferably at
least one is transparent in order to enable viewing the components in the
interior of the
housing. They may also be formed together of the same material with an
integral hinge
connection as will be explained. Referring to FIG. 12, the main housing is
shaped to form
a spiral bladder support and chamber from a central point of the housing
spiraling outward
to the terminal outlet face of the housing. The housing is formed of an inner
wall 1016
beginning at an inner end 1018 proximate the center of the housing and
spiraling outward
in a radially outwardly spiral to become an outer wall and continue to a
terminal end 1022,
joining the outer surface or portion thereof and forming a terminal wall 1024.
The angle
subtended by the spiral is preferably in a range from about 3/4 turn and about
two turns or
greater.
[0197] The inner wall 1016 forms a spiral support structure for
supporting an
elongated elastic tubular member 1026 forming an elastic bladder or reservoir.
The coils
of the elastic tube are supported in a common plane and spiral radially
outward. The
elastic tube or member 1026 is preferably pre-stretched up to about 30% with
an inner end
1028 secured on a barbed plug 1030 having a shoulder 1032. The shoulder 1032
is
positioned behind shoulders formed by inner extending wall portions 1034 and
1036
forming a receptacle for receipt of the plug 1030. The elastic tube or member
is stretched
and bends across the inner end 1018 or wall of mounting member 1016 and lies
compressed substantially flat, as it extends along the wall to an outlet end
1038 connected
to an outlet connector and valve assembly including a suitable coupling or
connector such
as a luer connector 1040.
[0198] The housing of the valve and connector assembly is of a tubular
configuration with an inner barbed connector 1042 over which an outer end 1038
of elastic
tube 1026 is mounted. The housing of the connector includes spaced apart disc
or
shoulder plates 1044 and 1046 which embrace and engage opposing sides of the
wall 1024
as the connector is inserted in a slot 1048 therein. This secures the
connector in place
against movement either inward or outward of the housing. The elastic bladder
1026 is
stretched and mounted between barbed connectors 1030 and 1042.
Date recue / Date received 2021-12-07
31
[0199] The connector assembly 1040 preferably includes a luer check
valve of a type
for such fittings normally available from the Halkey-Roberts Company of St.
Petersburg,
Fla. The valve (not shown) is a one-way check valve to prevent outflow until a
luer
connector is mounted on the outlet end of the connector which acts to release
or unseat the
valve.
[0200] The housing may be constructed of any number of suitable
engineering
therm forming materials such as, acrylonitrile butadiene-styrene (ABS),
polyvinylchloride (PVC), polyethylene terephthalate (PET), polyethylene
terephthalate
glycol (PETG) and the like. These are well-known lightweight plastics and are
materials
approved for medical devices.
[0201] The tubular member 1026 is preferably constructed of an inner
tube or sleeve
of an inert elastomer and an outer highly elastic tube or sleeve. A preferred
rubber
material for the inner sleeve is a thermoplastic material, e.g., rubber sold
under the mark
KRATON by Shell Chemical Company of Houston, Texas. These materials are
available
as KRATON D and G 2000 series rubber. These materials are biocompatable and
have
less than optimum elastic characteristics, and are referred to herein as semi-
elastic. When
stretched, they initially return to a position of about 75 to about 90 percent
of original
configuration over a reasonable period of time.
[0202] The outer sleeve is preferably made of a natural or synthetic
highly elastic
rubber such as latex, silicone or other rubber with excellent elastic
characteristics, and is
referred to herein as elastic. A material with good elastic characteristics
returns quickly
from a stretched condition to its original un-stressed or un-stretched
condition. A good
elastic material also has a uniform elastic force over the range stretched and
returns energy
put into it. A good elastic rubber can stretch in the range from about five
hundred to about
eight hundred percent and return most of the energy as it returns to its
original position.
Natural latex rubbers are a preferred material for the outer sleeve of tubular
member 1026.
However, certain other rubbers such as silicone rubber would also be suitable.
[0203] The pump 1010 may include a sensor to measure flow rate,
pressure, liquid
volume, and temperature among other characteristics. Multiple sensors may also
be used
throughout the interior. These sensors may be configured to communicate
wirelessly via
Wi-Fi, Bluetooth, and other wireless communication protocols as known in the
art to a
readout or other device (not shown) such as a controller. Of course, the
sensors may be
hardwired to communicate directly with a readout or other internal or external
device.
Date recue / Date received 2021-12-07
32
102041 Still another embodiment of system includes a pump 110 as
described in U.S.
Patent No. 5,080,652, FIGS 13 and 14
are directed toward a pump generally depicted as reference number 1310. The
pump 1310
is separate from the charging or filler pump. Moreover, it may be filled by
any suitable
means, such as a syringe or any other pressurizing devices or methods. The
housing 1312
has a substantially spherical configuration and is provided with coaxial, or
more
particularly aligned bores or ports 1314 and 1316, in which is mounted an
inflatable
bladder assembly. The housing 1312 may be made of unitary construction, such
as by
blow molding, or may be of two identical half shells assembled. The ports are
formed in
axial recesses 1318 and 1320. The inflatable bladder assembly includes a first
or inner
elongated semi-elastic sleeve 1322, and a pair of outer elongated latex rubber
elastic
sleeves 1324 and 1326 mounted on an elongated central cylindrical support
member 1328.
The inner sleeve 1322 is preferably made of a drug compatibility rubber with
low leach
characteristics that meets USP class 6 testing standards.
[0205] A rubber material for the inner sleeve 1322 is a class of
thermoplastic rubber,
e.g., sold under the mark KRATON by Shell Chemical Company of Houston, Texas.
These materials are available as KRATON D and G 2000 series rubber, and have
FDA
status for use in certain applications or ingredients of articles for food
contact. These
materials have less than optimum elastic characteristics, and are referred to
herein as semi-
elastic. When stretched, they return to a position of about 75 to about 90
percent of
original configuration.
[02061 The outer sleeves 1324 and 1326 are preferably made of a
natural latex
rubber with excellent elastic characteristics. A material with good elastic
characteristics
returns from a stretched condition to its original un-stressed or stretched
condition. A
good elastic material also has a uniform elastic force over the range
stretched. Natural
latex rubbers are the preferred material for the outer sleeves membranes 1324
and 1326.
[02071 The central support member 1328 is preferably of a generally
elongated
cylindrical configuration, with an annular radially extending retaining flange
1330 on one
end for engaging a shoulder 1332 on the housing 1312. The opposite end of the
support
member 1328 includes a bayonet type coupling with a retaining nut 1334. The
central
support member may be constructed of any suitable pharmaceutically compatible
material,
such as metals, plastics, glass, etc.
Date r
33
[0208] The support member 1328 includes an inlet port 1352
communicating by way
of a passage 1354, including a one-way valve 1356, 1358 with the interior of
the
membrane or sleeve 1322. Any suitable check valve may be used to permit
uncoupling of
the filling unit without leakage of fluid from the pressurized bladder. The
check valve
includes a cross through bore 1356 communicating with the end of passage 1354,
and in
which is slip fitted an elastic tube 1358, which may be of a suitable rubber
such as
silicone. The tube 1358 covers the end of passage 1354 to prevent back flow
from inside
the bladder formed by sleeve 1322. The tube 1358 collapses in response to
higher pressure
in passage 1354 enabling flow of liquid into sleeve 1322.
[0209] A sensor 1311 before the valve is configured to measure flow
rate, pressure,
liquid volume, and temperature among other characteristics. Multiple sensors
may also be
used throughout the interior. These sensors may be configured to communicate
wirelessly
via Wi-Fi, Bluctooth, and other wireless communication protocols as known in
the art to a
readout or other device (not shown) such as a controller. Of course, the
sensors may be
hardwired to communicate directly with a readout or other internal or external
device. The
sensors may be configured to communicate with the flow control device 1370,
e.g., a feed
-back loop as known in the art.
[0210] An outlet passage 1360 in support member 1328 communicates via
an outlet
port 1362 and suitable coupling assembly 1364, with an outlet or intravenous
feeding line
including, e.g., a two-part tube 1366, which includes a filter 1368, and may
include flow
control device 1370 and a male luer lock adaptor. The outlet line may be
controlled by a
suitable valve assembly (not shown) or preferably by the well known type clamp
known as
a clamp 1396. The luer lock 1374 has a valve that closes the outlet port when
the feeding
line is uncoupled therefrom. The coupling is effective to open the outlet
valve when
coupled to the outlet fitting. The delivery tubes 1366 may be selected in size
and length to
aid in maintaining a predetermined pressure and flow rate. The luer lock is
configured to
attach to a catheter, e.g., as shown in FIG. 1.
[0211] The elastic sleeves 1324 and 1326 are mounted over the sleeve
1322.
Sleeves 1324 and/or 1326 may be stretched radially when in position over
sleeve 1322,
e.g. 1324 is stretched radially over 1322, with 1326 slip fit over the
assemblies of 1322
and 1324. The outer bladder 1326 slips radially over the assembly of 1322 and
1324. The
composite assembly of 1322, 1324, 1326 is slideably engaged with a slip fit
over the
mandrel or support member 1328. Radial stretching of the bladder 1324
compensates for
Date recue / Date received 2021-12-07
34
material 1322's less than perfect elasticity. More specifically, the wall
thickness and
amount of stretch of bladder 1324 are selected to just compensate for bladder
1322's
material less than perfect elasticity. The initial strain conditions and
bladder wall
thicknesses are also chosen to minimize the non-linearity exhibited in a
bladder's stress
versus strain.
[0212] It is well known that a single bladder infusion device
constrained at both ends
exhibits a highly non-linear stress versus strain relationship. This causes a
time varying
flow characteristic. The inner bladder is chemically inert and the outer
bladder is elastic.
The structure and method for maintaining constant flow versus time while the
device is
infusing by radially stretching an intermediate bladder over the inner
bladder.
[0213] The inner semi-elastic drug compatible tube or membrane 1322 is
mounted
on the cylindrical support member 1328, preferably in a slightly snug but un-
stretched
radial fit, and essentially relaxed elongated or non-stretched longitudinal
fit. The inner
sleeve 1322 preferably has what shall be called a slip fit on the support
member. This slip
fit is preferably with a clearance on the order of about one-thousandths of an
inch of the
sleeve on the support. This provides a non-stretched fit, with essentially
zero volume of
the pressure chamber when in the non-stretched or totally relaxed state or
mode.
[0214] The elastic sleeves 1324 and 1326 are respectively stretch fit
and snug fit
radially over the inner semi-elastic sleeve 1322. The intermediate sleeve 1324
is radially
stretched up to about five percent over the inner sleeve 1322 for compressing
it. The outer
sleeve 1326 is slip fitted over the intermediate sleeve 1324. All of these
sleeves 1322,
1324, and 1326 are fitted over the support member 1328 and clamped at the ends
with a
pair of 0-rings 1376 and 1378. These 0-rings 1376 and 1378 bias the ends of
the multiple
sleeves into annular grooves 1380 and 1382 in the outer surface of the member
1328. The
0-rings 1376 and 1378 are held in place by the walls of the housing forming
the recesses
1318 and 1320. The multiple sleeves when being filled tend to elongate and
roll over the
ends thereof as shown in FIG. 14. The support member 1328 is of a fixed length
and
holds the ends of the sleeves at a fixed position. The multiple thin sleeves
easily roll over
the ends, thereof as the bladder is made up of the multiple sleeves it fills
and expands.
102151 The pressure applied by the pressure chamber, formed by the
multiple
sleeves, will be substantially a function of the thickness of the wall of the
elastic sleeve or
sleeves. For example, a typical two to three (2-3) psi may be obtained by a
wall thickness
of about eighteen to twenty-thousandths (0.018-0.020) of an inch. In order to
obtain
Date recue / Date received 2021-12-07
35
higher pressure with superior uniformity, a multi-layered sleeve configuration
as described
hereinabove has been found to be preferred.
[0216] As illustrated in FIG. 13, a plurality of sleeves (three
illustrated) 1322, 1326
and 1324 are slip fitted (non-stretched) on the support member. The inner
sleeve 1322 is
slip fitted on the support member 1328, and a second sleeve 1324 is slightly
stretch fitted
over the first sleeve 1322. Thereafter, a third sleeve 1326 is slip fitted
over the
intermediate sleeve 1324. These are shown in the fully deflated position in
FIG. 13 and in
the fully inflated condition in FIG. 14, showing the fold or roll over the
ends. These
multiple layers have been found to be superior to the use of thicker membranes
or sleeves
to obtain higher and uniform pressures. The use of multiple layers also
enables the use of
a semi-elastic substantially chemically (medically) inert inner membrane or
sleeve for
contact with the infusible liquid. The multiple sleeves will roll or fold over
at the ends, as
illustrated in FIG. 14. Thus, to increase the pressure, additional sleeves of
substantially
the same thickness are used.
[0217] When being filled, the elastic multi sleeve membrane has a
tendency to
elongate, but expands into a spherical configuration. The elongation is
accommodated in
this pump configuration by an accordion effect at the ends of the bladder, as
shown in
FIG. 14, wherein the bladder rolls over the ends thereof and outward along the
support
member 1328 as it expands outward to fill the housing 1312. The accommodation
of the
elastic membrane in the spherical configuration enables it to expand and
contract in its
natural fashion, and to maintain a substantially constant pressure and thereby
flow rate
over the intravenous injection period.
[0218] The layered or multiple sleeve configurations have been found
to better
accommodate the accordion fold and maintain a more uniform pressure than a
thicker
sleeve. The tubular elastic sleeve membranes are selected and mounted on the
support
member in a manner that enables them to roll or fold over at the ends when
being filled.
[0219] In operation, an assembled infuser pump unit is selected, and
the inlet port
1352 is secured to a source of fluid under pressure. As fluid is being
introduced into the
inlet, the valve 1358 collapses as fluid flows into the inner sleeve or
membrane 1322. As
the reservoir or bladder formed by the sleeves begins to fill, it expands and
attempts to
elongate. The ends of the sleeves begin to fold and roll over the ends thereof
as in FIG.
14. The bladder forms a substantially spherical shape as its natural form of
expansion.
Date recue / Date received 2021-12-07
36
The roll at the ends accommodates this expansion and aids in maintaining a
substantially
constant pressure over the range of infusion.
[0220] As the bladder deflates, the outer elastic membranes force the
inner semi-
elastic membrane back to substantially its original position. This helps to
evacuate the
entire volume of fluid. It also will be appreciated that any form of
pressurized filling
apparatus may be used.
[0221] FIG. 2A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention. FIG. 2B
illustrates a cross-sectional view of the continuous anesthesia nerve
conduction apparatus
shown in FIG. 2A.
[0222] Referring to FIGS. 2A-2B, a continuous anesthesia nerve
conduction
apparatus is generally depicted with reference to number 200. The apparatus
200 includes
a reinforced catheter 202 with and without the cannula 204. The beveled distal
tip of the
cannula 204 is shown to be protruding slightly from the distal tip of the
catheter 202. The
tip may also be curved. The proximal portion of the catheter 202 includes
winged hub
206. The cannula 204 includes a hub 207 configured to abut and engage with the
winged
hub 206 via a locking mechanism 208. The wings 210, 212 optionally include an
adhesive
configured to attach to a patient. Optionally, the wings may also include a
warning label
configured to indicate and distinguish the type of catheter, e.g., anesthesia
catheter versus
an intravenous (IV) catheter. The catheter 202 optionally includes at least
one port 214.
The port 214 is configured to supply a pharmacological agent in at least a
radial direction
from a longitudinal axis of the catheter 202. That is, the port 214 permits
the distribution
of the infused pharmacological agent to the targeted nerve(s) 116 in a
circumferential and
linear pattern at the distal end. The port 214 may be configured to have small
or large
diameters, e.g., a diameter in the range from about 0.1 mm to about 2 mm or
greater.
There also may be a plurality of ports arranged circumferentially around the
perimeter of
the catheter, linearly done in axis of the catheter, and/or in another
predetermined
geometric pattern.
[0223] The proximal hub 207 of the cannula 204 is configured to accept
a tip of a
standard syringe 218. The hub 207 may include alignment marks as described
herein, e.g.,
with reference to FIGS. 31A-33. The syringe 218 may be used to inject a
pharmacologic
agent, e.g., solution for hydro-dissection of tissue surrounding to the
targeted nerve(s) 106
during catheter placement. Once in place adjacent to the targeted nerve(s)
106, the lock
Date recue / Date received 2021-12-07
37
208 is disengaged, the cannula 204 is withdrawn, and the catheter 202 is
positioned to
provide continuous nerve block.
[0224] The catheter hub 206 is further configured to accept a
connector 219 on the
end of the connecting tube 112. The connecting tube 112 is coupled to an
infusion pump
on the opposite end. A frictional region 220, e.g., pebbled region, is
optionally added to a
proximal portion of the catheter 202. The frictional region 220 is configured
to aid in
sealing an insertion site in the tissue, minimize leakage of contrast and/or
pharmacological
agent, and minimize movement of the catheter 202. The frictional region 220
may include
an adhesive material including a bioresorable material and non-bioresorable
material.
Alternatively, instead of or in combination with the friction material 220 the
proximal
portion may have an enlarged diameter to further aid in sealing the insertion
site. The
enlarged diameter may be greater than the diameter of the rest such that the
diameter is
about 2% to about 15% greater than the diameter of the rest of the catheter.
The
orientation and the location of the catheter 202 and its lateral port can be
monitored
through the use of markers, e.g., radiopaque, echogenic, combinations of the
same, and the
like, via visualization techniques.
[0225] Referring now to FIG. 2B, the distal portion of the catheter
202 includes an
echogenic region 222 including echogenic material to aid with ultrasound
visualization of
a distal tip of the catheter 202. The catheter 202 includes a lumen 226
extending from a
proximal end to a distal end. The hub 206 also includes a lumen 228 in
communication
with the lumen 226. Finally, the cannula 204 and hub 207 of the cannula
includes a lumen
230 extending from a proximal end to a distal end. The lumens 226, 228, and
230 are
arranged to form one continuous lumen for administering a pharmacological
agent or other
medical device. The other medical device may include a balloon, active
visualization
device (imaging probe), surgical instrument, and the like. A reinforcement
material 224,
e.g., axial stays, metal and the other reinforcement material may be used for
reinforcement
of the catheter to minimize kinking or bending when desired. That is, the
material 224 is
embedded in a body of the catheter 202 to provide enhanced rigidity, thereby
preventing
bunching and kinking of the catheter 202. The catheter 202 may also be
configured with
various rigidities along a longitudinal axis of the catheter, e.g., the
proximal portion may
be stiffer than the distal portion and vice versa. Optionally, an anti-
restrictive member or
supplemental catheter may be used to further prevent kinking as described
herein, e.g.,
with reference to FIGS. 37A-37G.
Date recue / Date received 2021-12-07
38
[0226] FIG. 3A illustrates a perspective view of the continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention. FIG. 3B
illustrates a cross-section view of the continuous anesthesia nerve conduction
apparatus
shown in FIG.3A. FIG.3C illustrates an enlarged view of the distal section of
the
apparatus shown in FIG. 3A.
[0227] Referring to FIGS. 3A-3C, a continuous anesthesia nerve
conduction
apparatus is generally depicted with reference to number 300. The apparatus
300 includes
a reinforced catheter 302 with and without a cannula 304. The beveled distal
tip of the
cannula 304 is shown to be protruding slightly from the distal tip of the
catheter 302. The
proximal portion of the catheter 302 includes a winged hub 306. Wings 308, 310
optionally include an adhesive configured to attach to a patient. The catheter
302
optionally includes at least one port 312. The port 312 is configured to
supply a
pharmacological agent, e.g., contrast, medicine, or the like, in at least a
radial direction
from a longitudinal axis of the catheter 302. That is, the ports 312 permit
the distribution
of the infused pharmacological agent to the targeted nerve(s) 116 in a
circumferential
and/or linear pattern.
[0228] The apparatus 300 further includes an embedded conductive
element 314 and
a conductive 316 tab. The conductive element 314 is configured to transmit
electrical
activity used to activate a nerve, e.g., dc current, voltage, ac current,
square wave, or
combination, to a distal portion of the catheter 302 and cannula 304. In a
preferred
embodiment, the electrical activity is generated by a nerve stimulator
generator (not
shown), e.g., Stimuplext HNS11 Peripheral Nerve Stimulator by B. Braun,
Stimuplex
Dig RC by B.Braun, MultiStim VARIO by Pajunk, and EzStim0 stimulator by Life-
Tech
International. In a preferred embodiment, the embedded conductive element 314
is an
embedded wire.
[0229] An electrode cap 318 is affixed to a distal end of the catheter
302. The
electrode cap 318 is coupled to the embedded wire 314 and is configured to
allow for
peripheral nerve(s) simultaneous stimulation via the cannula 304 and the
catheter 302.
The embedded wire 314 is within the body of the catheter and connects the
electrode cap
to the proximal electrode connector 316 on the catheter hub 306.
[0230] In this embodiment, an electrical signal is to be introduced
via a peripheral
nerve stimulator connected to the proximal electrode connector 316 and
propagated to the
electrode cap 318 on the distal tip of the catheter 302 with an internal
conductive wire 314.
Date recue / Date received 2021-12-07
39
The electrode cap 318 provides transmission to a distal tip of a cannula 304.
The catheter
body 302 acts as an insulator for the rest of the cannula 304. Therefore,
transmission of a
signal with a single connection may be supplied via a distal tip of the
cannula 304, the
electrode cap 318 or singly via the electrode cap 318 by retracting the
cannula 304
proximal of the electrode cap 318. Optionally, the outer surface of the
electrode cap 318
may be insulated with an insulated material. In this embodiment, when an
electrical signal
is applied to the outer surface of the electrode cap 318 does not transmit an
electrical
signal as it is insulated.
[0231] A proximal hub 320 of the cannula 304 is further configured to
accept a tip of
a standard syringe (not shown). The proximal hub 320 includes a connector 322
for
releasably coupling cannula hub 320 to the catheter hub 306. The catheter hub
306 is
further configured to accept a connector (not shown) on an end of the
connecting tube 112.
The connecting tube 112 is coupled to an infusion pump on the opposite end
(FIG. 1, 110).
A frictional region 324, e.g., at least a partially coarse region, is
optionally added to a
proximal portion of the catheter 302. The frictional region 324 is configured
to aid in
sealing an insertion site in the tissue, minimize leakage of contrast and/or
pharmacological
agent, and minimize movement of the catheter 302. Moreover, the diameter at
the
frictional region may also be enlarged as described herein.
[0232] A distal portion of the catheter 302 includes an echogenic
region 323
including echogenic material to aid with ultrasound visualization of a distal
tip of the
catheter 302. The echogenic material may include metallic flakes, reflective
flakes
derived from titanium, stainless steel, copper or other similarly inert metals
or alloys that
reflect the sound waves generated by the ultrasound probe. The catheter 302
includes a
lumen 326 extending from a proximal end to a distal end. The hub 306 also
includes a
lumen 328 in communication with the lumen 326. Finally, the cannula hub 320
includes a
lumen 330 extending from a proximal end to a distal end. The lumens 326, 328,
and 330
are arranged to form one continuous lumen for administering a pharmacological
agent or
other medical device. The other medical device may include a balloon, active
visualization device (imaging probe), surgical instrument, and the like.
[0233] A reinforcement material 332, e.g., axial stays, metal and the
like as known
in the art, is added to a body of the catheter 302 to provide enhanced
rigidity, thereby
preventing bunching and kinking of the catheter 302. A plurality of
reinforcement
material 332 may be used. The catheter 302 may be configured with various
rigidities
Date recue / Date received 2021-12-07
40
along a longitudinal axis of the catheter, e.g., the proximal portion may be
stiffer than the
distal portion.
[0234] FIG. 4 illustrates an enlarged view of a distal section of the
conduction
apparatus according to yet another embodiment of the invention.
[0235] Referring to FIG. 4, a distal tip of the apparatus is generally
referred to as
reference number 400. The rest of the apparatus (not shown) is similar to the
catheter
described in FIGS. 3A-3C and will not be described further. In this
embodiment, the
distal tip of the catheter 302 includes a retractable flap 402. The distal
port of the catheter
is patent while the introducing cannula 304 is inserted through the lumen of
the catheter
302, but the retractable flap 402 is configured to deploy once the cannula 302
is
withdrawn; that is, retractable flap 402 is configured to move from a closed
position to an
open position as shown. In a closed position and when the catheter is in use,
only the side
port 312 is utilized to deliver pharmacological agent.
[0236] FIG. 5 illustrates an enlarged view of a distal section of the
conduction
apparatus according to yet another embodiment of the invention.
[0237] Referring to FIG. 5, a distal tip of the apparatus is generally
referred to as
reference number 500. The rest of the apparatus (not shown) is similar to the
catheter
described in FIGS. 3A-3C and will not be described further. In this
embodiment, the distal
tip of the catheter 302 includes a plurality of retractable flaps 502 that are
configured in an
open position and closed position by movement of a cannula 304. More
specifically, the
distal port of the catheter is patent while the introducing cannula 304 is
inserted through
the lumen of the catheter 302, but the retractable flap 502 is configured to
deploy once the
cannula 304 is withdrawn; that is, retractable flap 502 is configured to move
from an open
position to a closed position. In a closed position and when the catheter is
in use, only the
side port 312 is utilized to deliver pharmacological agent.
[0238] FIG. 6A illustrates a perspective view of the continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention. FIG. 6B
illustrates an enlarged view of a distal section of the continuous anesthesia
nerve
conduction apparatus according of FIG. 6A in various configurations.
[0239] Referring to FIGS. 6A-6B, a continuous anesthesia nerve
conduction
apparatus is generally depicted with reference to number 600. The apparatus
600 is
similar to the apparatus described with reference to FIG. 3A-3C except for the
distal
portion of the reinforced catheter 602. The distal portion of the reinforced
catheter 602
Date recue / Date received 2021-12-07
41
with a preformed shape, controllable shape or resilient shape. In one
embodiment, when a
cannula 604 is inserted through the lumen of the reinforced catheter 602, the
distal tip of
the catheter is straightened by the cannula 604, but when the cannula 604 is
withdrawn,
the distal tip takes its preformed shape. The shape may be an "L" shape as
noted with
reference to element 606, "U" shape as noted with reference to element 608, or
curved as
in 610. The proximal electrode connector 612 is positioned on the side of the
proximal
catheter hub 614 so that the direction of the preformed distal tip of the
catheter is
corresponding with the electrode connector 612. Alternatively, the distal end
portion of
the catheter 602 may be controllable with a wire system (not shown) to various
geometries, e.g., "L" shape, "U" shape, or curved shape. The various
geometries allow
the distal portion of the catheter to be closer to a desired nerve or nerve
bundle thus
permitting a better distribution on anesthetic solution while keeping more of
the catheter in
close proximity to the nerve(s).
[0240] Catheters as described herein may be constructed, in whole or
in part,
utilizing a variety of degradable materials, polymeric materials, synthetic or
natural, and
combinations thereof. Furthermore, the catheters may be composed such that the
portion
of the catheter that enters and remains in the patient is degradable, but the
portion that
remains substantially outside of the patient is not degradable. Furthermore, a
break point
may exist between the two materials. The break point may be configured to
facilitate
breaking.
[0241] In some embodiments, the catheters may be composed of multiple
components that are mixed as a blend, such as a plasticized system, and/or as
a microphase
immiscible system. If suitable reactive groups are introduced into the formed
catheters,
what is commonly known as a thermoset, or chemically cross-linked system can
be
generated under appropriate curing conditions. The formed catheters can also
be
composed in the form of a laminate or a fibrous reinforced composite. Of
course, the
properties of the selected composition, e.g., molecular weight, glass
transition
temperature(s), crystallinity, and/or the extent of cross-linking will dictate
the desired
properties of the catheters. The catheters may also be coated with a variety
of therapeutic
agents such as pain, antibacterial, antimicrobial or anti-inflammatory
coatings, drug
coatings, and the like. The catheters may also be composed of and/or coated
with anti-
microbial materials and micro surfaces such as silver nanoparticles, for
example the
catheter may be impregnated with silver nanoparticles, to provide
antibacterial properties.
Date recue / Date received 2021-12-07
42
[0242] FIG. 15A illustrates an embodiment of a catheter tip. FIG.
15B illustrates
another embodiment of a catheter tip;
[0243] Referring to FIGS. 15A-15B, it is shown that embodiments of
catheters may
be used with ports as described in U.S. Patent No. 7,004,923.
The catheter is generally described herein and in this
embodiment includes a distal portion as shown via reference number 1550. The
distal
portion 1550 includes an outer tube 1552. A plurality of fluid ports 1556 are
provided
within the tube 1552, preferably throughout the entire circumference thereof.
The portion
of tube 1552 that includes the ports 1556 defines the infusion section of
catheter 1550. An
access for the cannula is provided within the distal tip 1558 of the tube
1552. Moreover,
the distal end portion may a preformed shape as described herein.
[0244] The tube 1552 may be formed from any of a variety of
suitable materials,
giving due consideration to the goals of non-reactivity to anatomical systems,
such as
nylon, polyimide, Teflon, biodegradable materials previously discussed and
other
materials known to those skilled in the art, giving due consideration to the
goals of non-
reactivity to anatomical systems, flexibility, light-weight, strength,
smoothness, and
safety. In a preferred configuration, the tube 1552 is preferably a 20 gauge
catheter tube,
having inside and outside diameters of 0.019 inches and 0.031 inches,
respectively. The
ports 1556 of tube 1552 are preferably about 0.015 inches in diameter and
provided at
equally spaced axial positions along the tube 1552. The holes 1556 are
preferably
arranged so that every hole is angularly displaced about 120 relative to the
longitudinal
axis of the tube 1552, from the angular location of the previous hole. Other
angular
displacements are possible, e.g., in a range from about 5 to about 180
relative to the
longitudinal axis of the tube.
[0245] The axial separation between adjacent ports 1556 is
preferably within the
range from about 0.1 inches to 0.3 inches, and more preferably about 3/16
inch. Also, the
infusion section can have any desirable length but is preferably about 0.5 to
20 inches
long, and more preferably about 10 inches long. This configuration results in
a thorough,
uniform delivery of fluid throughout a generally linear segment of the wound
area. Of
course, the ports 1556 may be provided in any of a variety of alternative
arrangements. In
addition, each port 1556 or only a portion of the ports may be surrounded with
a marker
1551 to permit visualization, e.g., radiopaque, echogenic, and combinations of
the same.
DCILC I cyuc I 1...ocuc I c,civcu cvc I - I c-vi
43
[0246] FIG. 15B illustrates a catheter which is generally described
herein and in this
embodiment includes a distal portion as shown via reference number 1553. This
embodiment is better suited for relatively high flow rate delivery of fluid to
a region
within an anatomical system. Catheter 1550 includes a tube 1552 having a
plurality of
ports 1556 of increasing size. In particular, the more distal ports are larger
in diameter
than the more proximal ports. The position of the ports 1556 on the tube 1552
defines the
length of the infusion section of the catheter 1550. The infusion section can
have any
desired length. The proximal end of catheter 1550 is connected to a fluid
supply, and a
guidewire and/or guidewire lumen may also be provided for aiding in the
insertion of
catheter 1550 into the anatomy. One or more marking lines 1555, 1559 and
markers 1561
may surround a port 1556 to permit visualization, e.g., radiopaque, echogenic,
and
combinations of the same.
[0247] As discussed above, for high or low pressure fluid delivery,
ports nearer to
the distal end of a catheter tube generally have increased flow resistance
compared to ports
nearer to the proximal end of the tube. Also, the fluid flowing through the
more distal
holes experiences a greater pressure drop. Consequently, there is generally a
greater flow
rate of fluid through the more proximal holes, resulting in non-uniform fluid
delivery. In
contrast, catheter 1550 advantageously provides substantially uniform fluid
delivery
through substantially all of the ports 1556, under relatively high flow rate
conditions. This
is because the larger size of the more distal holes compensates for their
increased flow
resistance and pressure drop. In other words, since the more distal holes are
larger than
the more proximal holes, there is a greater flow rate through the more distal
holes than
there would be if they were the same size as the more proximal holes.
Advantageously,
the holes 1556 are provided in a gradually increasing size which results in
substantially
uniform fluid delivery. In addition, the ports 1556 may be sized so that they
combine to
form a flow-restricting orifice. Moreover, the distal end portion may a
preformed shape as
described herein.
[0248] FIG. 16 illustrates an embodiment of a single handed catheter
advancing
device.
[0249] Referring to FIG. 16, the invention is a single handed catheter
advancing
device and is generally depicted as reference number 400. The single handed
device 400
allows a catheter to be advanced into a patient single handed. This device is
not limited to
only catheters described herein, but may be used with conventional needle over
the
Date recue / Date received 2021-12-07
44
catheter configurations. The device 400 includes a body 428 having free
revolving rollers
424. The free revolving rollers 424 can be operated single handedly by the
operator by
placing the thumb of the operator on the free revolving rollers 424 and
turning the rollers
424 which can insert or remove the catheter 402 depending upon the direction
the rollers
424 are being turned. The catheter 402 is inserted through the catheter
insertion opening
420 which is located at the end of the body 428. The free revolving rollers
424 advance
the catheter 402 into the needle 404. The free revolving rollers 424 may
include rubber
grippers on the roller 424. The rubber grippers can be made of any suitable
material,
including but not limited to nylon, rubber, teflon, polyamide, polyfiline,
other polymers
and the like, or combinations thereof. The body 428 is also connected to a
luer 405, such
as a swivel male luer. The luer 405 can be connected to a needle hub 421,
which is also
connected to the needle 404 either permanently or temporarily. For example,
the luer 405
may contain threads that may engage with threads on the needle hub 421. The
needle hub
421 can disconnect from the luer 405. In addition, the luer 405 may be an
integral portion
of the body 428.
[0250] The device operates to advance the catheter 402 into the needle
404 with one
hand, while leaving the other hand of the operator free to perform other
tasks, such as
attach and operate a nerve stimulator or use an ultrasound to locate a nerve
bundle. The
device may also be used with an ant-restriction member and/or supplemental
catheter as
described herein. The operator introduces the needle 404 to the patient. The
single
handed device 400 may be connected as the operator introduces the needle 404
to the
patient, or it may be attached at a later time. Once the needle 404 is in
place, a catheter
402 may be introduced into the hollow needle 404. The device 400 contains
channel 429,
which directs the catheter 402 introduced to the device through the opening
420 through
the luer 405, into the needle hub 421 and eventually into the needle 404. The
operator can
control the advancement of the catheter 402 using the rollers 424 on the body
428. Once
the catheter 402 is in place, the operator may remove the needle 404 and
device 400 in a
single motion by sliding the needle 402 attached to the device 400 over the
catheter 402.
Alternatively, the operator may remove the needle 402 and device 400 in two
steps by first
disconnecting the device 400 from the needle 404 at the needle hub 421, then
removing
the needle 404 from the patient, while leaving the catheter 402 in place. The
catheter 402
may then be joined to an apparatus, such as an infusion pump.
Date recue / Date received 2021-12-07
45
[0251] FIG.17A illustrates a single handed catheter advancing device
according to
another embodiment. FIG. 17B illustrates a perspective view of a single handed
catheter
advancing device illustrated in FIG. 17A. FIG. 17C illustrates a perspective
view of a
single handed catheter advancing device illustrated in FIG. 17A with a
catheter;
[0252] As illustrated in FIGS. 17A-17C, the device is generally
depicted as
reference number 500. The device 500 includes a catheter insertion opening 520
located
adjacent to one of the free revolving rollers 524 of the body 528 and used to
advance the
catheter 502 through a luer 505 and into a needle or cannula. A handle 530 may
be
permanently or temporarily attached to the body 528 using any suitable means.
The
handle 530 may be ergonomical and made of any suitable material. Furthermore,
the
handle 530 may include indents for fingers ¨ in particular it may include a
groove to
receive a portion of the thumb of the user. The handle 530 may be tapered, may
vary in
length, and may vary in diameter or size. In an alternative embodiment, a
catheter
insertion opening 520 may be located anywhere on the body of the single handed
catheter.
By way of example, the catheter insertion opening 520 may be located near the
end of the
handle 530, which is similar to the configuration of FIG. 16. In this
configuration, the
opening 520 is aligned with a central-axis of the handle 530.
[0253] The body 528 is shown with the free revolving rollers 524 and
is adjacent to
the catheter insertion opening 520, which is located on the body 528 adjacent
to the free
revolving rollers 524. Luer 505 may be used to attach the device 500 to a
needle, through
the needle hub 521.
[0254] In one embodiment, the catheter 502 is advanced through the
catheter
insertion opening 520 of the body 528, which is adjacent to one of the free
revolving
rollers 524. The cannula or needle 504 is attached to the device 500 through
the luer 505,
which is connected to the needle hub 521. The catheter advances through the
luer 505,
through the needle hub 521, and into the needle 504.
[0255] FIG. 18 illustrates an operational systematic view of the
single handed
catheter advancing device 500 as illustrated in FIG.17C. The device 500
includes a needle
504 which remains external to the patient. The sheath 504 is inserted through
the needle
hub 521 and the needle 504. The needle hub 521 is connected to the device 500
through a
luer 505.
[0256] Nerve(s) 511 lying in deep in tissue below the exterior surface
of the patient
are targeted to receive a pharmacological agent. A subcutaneous distal portion
of the
Date recue / Date received 2021-12-07
46
needle 508 is shown positioned in close proximity to the targeted nerve(s)
511, e.g., nerves
of the brachial plexus. A nerve stimulator (not shown) may be used to
stimulate the
nerve(s) 511. A nerve stimulator conducting wire 577 is electrically coupled
between a
nerve stimulator (not shown) and needle 504 to provide the requisite single to
the needle
504. Once the needle is in place, the catheter 502 may be advanced through the
needle.
The needle may be removed and the hub 521 disconnected from the luer 505.
[0257] Next, an infusion pump may be filled with a pharmacological
agent, e.g.,
medication such as a nerve block, and the pump is connected to the apparatus.
The pump
can include ON-Q0 C-bloc- Continuous Nerve Block System by I-Flow Corporation,
PainPump 1, PainPump 2, PainPump 2 BlockAid by Stryker Corporation, and
GoPump0
or GoBlockt by Symbios and may be any of the embodiments previously explained
and
described with reference to FIGS. 7-14. Of course any described catheter
herein may also
be used with devices of FIGS. 15-18.
[0258] The devices of FIGS. 15-18 aid a user in single handedly
advancing and
retracting a catheter to a desired location, e.g., nerve location. Thereby,
the user may use
the other free hand to aid with visualization. These devices may be used with
conventional catheter-through-needle systems. It is also noted that these
devices are not
required for single handed operation advancement, retraction of a catheter
and/or cannula,
but rather further aid a user in that regard.
[0259] FIG. 19A illustrates an embodiment of a solid introducer. FIG.
19B
illustrates the solid introducer of FIG. 19A in a catheter.
[0260] Referring to FIGS. 19A-19B, the solid introducer catheter
system is generally
depicted as reference number 600. The system includes a solid introducer 604.
The solid
introducer 604 may be used with the catheter 602 or other catheters described
herein. The
solid introducer 604 fits within the catheter 602. The catheter 602 may be a
reinforced
catheter and may include at least one or a plurality of ports 607 near the
distal tip of the
catheter 602. Ports as described anywhere herein, e.g., in FIGS. 15A-15B, may
also be
used.
[0261] On the proximal end of the catheter 602 is a catheter hub 621.
The solid
introducer 604 may also include an optional curved tip 603 which may be used
as a cutting
surface to insert the solid introducer catheter system 600 into the patient.
The solid
introducer 604 may include an optional stimulator connection site 609 wherein
a
stimulator (not shown) may be connected through the solid introducer 604. The
optional
Date recue / Date received 2021-12-07
47
stimulator connection site 609, when inserted into the catheter 602 may rest
on the catheter
hub 621 which controls the depth of insertion of the solid introducer 604
through the
catheter 602 such that the distal tip 603 of the solid introducer 604
protrudes from the tip
of the catheter 602. Furthermore, the stimulator connection site 609 is
adjustable along
the length of the solid introducer 604. Additionally, a needle hub 605 may be
used by the
operator to pull the solid introducer 604 from the patient once the catheter
602 is in place.
Once the solid introducer 604 has been removed from the catheter 602, the
catheter hub
621 may be used to connect the catheter 602 to the remaining system or other
device.
[0262] FIG. 20 illustrates another embodiment of the present
invention, which is a
hollow introducer catheter system 700. In this system, the introducer 704 is
hollow. The
hollow introducer 704 is advantageous because it allows a guidewire 734 to sit
within the
introducer 704 which sits inside of the catheter 702. The catheter 702 may be
a tightly
wound wire coil through the majority of the body of the catheter 702, but near
the distal
tip of the catheter 702 becomes a loosely wound wire which will allow for
flexibility. The
distal end of the catheter 702 may also include at least one or a plurality of
ports 736. The
introducer hub 705 rests upon the catheter hub 721, which controls the depth
of the
introducer 704 within the catheter 702. Once the introducer 704 has been
removed, the
catheter hub 721 may be used to connect the catheter 702 to the remaining
system or other
device.
[0263] FIG. 21 illustrates an embodiment of a guidewire.
[0264] Referring to FIG. 21, the guidewire 734 may be used with
catheters as
described herein. In one embodiment, the guidewire 734 is helpful for
positioning the
catheter 702 and/or stimulating the nerve bundle in the patient. Optionally,
the guidewire
734 may be equipped with a flexible preformed tip 736 which allows for
directional
advancement of the catheter. The flexible preformed tip may be straightened
out to pass
through a needle or catheter, but will return to its preformed shape once it
has exited the
needle or catheter. In some embodiments, the position of the catheter follows
the
preformed shape of the guidewire once the guidewire is withdrawn. Near the
guidewire
hub 721, there is a directional tab 738 which corresponds to the direction and
location of a
flexible tip 736 on the guidewire 734. A stimulator (not shown) may also be
attached to
the directional tab 738. The guidewire 734 may be used either in the hollow
introducer
704 or in the catheter 702.
Date recue / Date received 2021-12-07
48
[0265] FIG. 22A illustrates another embodiment of a hollow introducer
in a catheter
with a sleeve. FIG. 22B illustrates another embodiment of a guidewire in a
catheter with a
sleeve.
[0266] Referring to FIGS. 22A and 22B, a sleeve 740 used in the
catheter system
700 which allows for the reinsertion of an introducer 704 into the catheter
702 for
repositioning of the catheter 702. That is, the sleeve will prevent tears in
an external or
internal surface of a catheter 702 upon reinsertion or repositioning of the
catheter 702
when a cannula is required to reposition the catheter by advancing through
tissue. The
sleeve may also be utilized to prevent kinking of the catheter.
[0267] FIG. 23 illustrates an embodiment of the continuous anesthesia
nerve
conduction apparatus. The apparatus is generally depicted as reference number
2200. The
apparatus 2200 includes an introducer 2204, which may be a solid introducer or
a hollow
introducer, configured to fit within a catheter 2202 with at least one port
2214. An insert
2219 abuts and engages between the introducer end 2207 and the catheter hub
2206. The
introducer 2204 slides into the catheter 2202, through the catheter hub 2206
and through
the center of the insert 2219. The insert 2219 is configured, such that the
user may access
and connect a nerve stimulation device to the exposed segment of the
introducer 2204
allowing for the introducer 2204 to become a stimulatable needle. The insert
2219 may
contain threads or other type of fitting on either or both sides that engage
with the
introducer end 2207 and/or the catheter hub 2206.
[0268] The catheter 2202 may include markings as described herein,
e.g., markings
as described with reference to FIGS. 28A-28B. Moreover, the catheter 2202 may
include
a preformed resilient distal portion configured to position the distal portion
at least
partially around a nerve. The preformed resilient distal portion may be
configured to
minimize dislodgment of the catheter 2202 from a treatment situs. Optionally,
the catheter
2202 may be configured to fixedly bend from a first position to a second
position with
application of curved guidewire and curvature relative to a longitudinal axis
of the catheter
2202 the curvature may be in a range from about 1 degree to about 180 degrees,
more
preferably the curvature is a range from about 80 degrees to about 110
degrees. The
catheter 2202 may configured as described in FIGS. 6A-6B or any embodiment
described
herein like with any other catheter described herein.
[0269] FIG.24 is a view of the insert 2219. The insert 2219 contains
openings 2223
which allows the introducer to fit through the insert 2219. A portion of the
insert 2223
Date recue / Date received 2021-12-07
49
may contain threads to engage with an exterior thread on the introducer 2207
which may
hold the introducer 2207 in place during use. Alternatively, the insert 2219
may be a slip
fit, such that once the introducer 2207 is in place, it fits snugly within the
insert 2219. In
another embodiment, the insert 2219 contains threads on the end that abuts the
introducer
end, and engages with threads on a portion of the introducer. In another
embodiment, the
insert 2219 contains threads or other fittings on the end that abuts the
catheter hub, which
engages with threads on the catheter hub. In another embodiment, the insert
2219 contains
threads on both ends. Once the catheter is in place, the user may connect a
nerve
stimulation device to the exposed segment of the introducer shaft to convert
the introducer
into a stimulating needle for nerve localization.
[0270] In some embodiments, the insert 2219 contains at least one
optional opening
2221. The opening 2221 may be any shape or size and may provide access to the
introducer through the insert 2219. In other embodiments, the insert 2219 is a
solid piece,
without any openings 2221. In still other embodiments, the insert is tapered
on one end
such that the tapered end comes into contact with the introducer. The insert
2219 may be
connected to a stimulator in order to stimulate the introducer. In still other
embodiments,
the insert 2219 may be ergonomical and may include indents for fingers ¨ in
particular it
may include a groove to receive a portion of the thumb of the user. The insert
2219 may
assist the user to disconnect the introducer from the catheter with the use of
only one hand.
[0271] The insert 2219 may vary in length and may be made of any
suitable
materials. In some embodiments, the insert 2219 is made from a polymeric
material. In
other embodiments, the insert 2219 is made of an electrically conductive
material. In
other embodiments, the insert 2219 may be made of a polymeric material, which
has been
impregnated with an electrically conductive material.
[0272] FIG. 25A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention in first
orientation. FIG. 25B illustrates the continuous anesthesia nerve conduction
apparatus of
FIG. 25A in a second orientation. FIG. 25C illustrates a guidewire according
to another
embodiment of the invention. FIG. 25D illustrates a guidewire according to
another
embodiment of the invention.
[0273] Referring to FIGS. 25A-25D, a continuous anesthesia nerve
conduction
apparatus is generally depicted as reference number 2500. The apparatus 2500
includes an
integrated guidewire with a needle to allow for single handed deployment of
guidewire by
Date recue / Date received 2021-12-07
50
advancing the tab on the needle hub. Also this apparatus reduces procedural
steps by not
having to detach the syringe before advancing guidewire. The apparatus 2500
includes a
reinforced catheter 2502 over a cannula 2504 with an integrated hub 2506. The
catheter
2502 includes a port 2503. The hub includes a guidewire advancer 2508
configured to
move a guidewire 2510 from a first position to a second position with
activation from a
user, e.g., a thumb of a user, as shown by the arrow. The catheter 2502 can
slide off the
cannula 2504. The guidewire 2510 may be configured with an angled geometry
2512 at a
distal tip to aid bending a distal portion of the catheter 2502 around or
partially around a
nerve. The cannula 2504 includes a lumen extend from proximal portion to a
distal
portion to allow fluid transfer. The catheter and/or cannula may include
markings as
described here to aid with location of each to a desired treatment situs. The
guidewire
may also be a steerable guidewire as known in the art.
[0274] FIG. 26A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention. FIG.
26B
illustrates a cross-sectional view of the continuous anesthesia nerve
conduction apparatus
according to FIG. 26A.
[0275] Referring to FIGS. 26A-26B, a continuous anesthesia nerve
conduction
apparatus is generally depicted with reference to number 2600. In this
embodiment, an
integrated catheter with a dual lumen is illustrated. The apparatus 2600
includes a catheter
2602 having a first lumen 2604 and a second lumen 2606. The first lumen 2604
and
second lumen 2606 merge to one lumen 2607 at a distal portion of the catheter.
The first
lumen 2604 extends from a proximal portion to a distal portion of a hub 2608.
A port
2610 is in fluid communication with the first lumen 2604. The hub 2608
includes a
guidewire advancer 2508 configured to a move a guidewire 2510 from a first
position to a
second position with activation from a user, e.g., a thumb of a user.
[0276] The guidewire 2510 may be configured with an angled geometry
2512 at a
distal tip to aid bending a distal portion of the catheter 2502 around or
partially around a
nerve. The catheter 2602 in this embodiment is configured to puncture a skin
directly and
has functional characteristics as a cannula. The catheter may include a side
port or
plurality of ports. The catheter may include markings as described here to aid
with
location of each to a desired treatment situs. Optionally, an additional
removable sleeve
may be utilized over the catheter 2602.
Date recue / Date received 2021-12-07
51
[0277] FIG. 27A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention. FIG.
27B
illustrates a cross-sectional view of the continuous anesthesia nerve
conduction apparatus
according to FIG. 27A.
[0278] Referring to FIGS. 27A-27B, a continuous anesthesia nerve
conduction
apparatus is generally depicted with reference to number 2700. In this
embodiment, an
integrated catheter with a dual lumen is illustrated. The apparatus 2700
includes a catheter
2702 having a first lumen 2704 and a second lumen 2706. The first lumen 2704
and
second lumen 2706 extend from a proximal portion to a distal portion of a hub
2708. A
port 2710 is in fluid communication with the first lumen 2704. The hub 2708
includes a
guidewire advancer 2508 configured to move a guidewire 2510 from a first
position to a
second position with activation from a user, e.g., a thumb of a user.
[0279] The guidewire 2510 may be configured with an angled geometry
2512 at a
distal tip to aid bending a distal portion of the catheter 2502 around or
partially around a
nerve. The catheter 2702 in this embodiment is configured to puncture a skin
directly and
has functional characteristics as a cannula. The catheter may include a side
port or
plurality of ports. The catheter may include markings as described here to aid
with
location of each to a desired treatment situs. Optionally, an additional
removable sleeve
may be utilized over the catheter 2702.
[0280] FIG. 28A illustrates a distal end of a continuous anesthesia
nerve conduction
apparatus according to another embodiment of the invention. FIG. 28B
illustrates a distal
end of a continuous anesthesia nerve conduction apparatus according to another
embodiment of the invention.
[0281] Referring to FIGS. 28A, a distal portion 2800 of a catheter
2802 includes a
first port 2804, second port 2806 and third port 2808. The first port 2804 and
second port
2806 are oriented on opposite side of the catheter 2802. A plurality of
markings 2810,
2812, 2814, 2816, 2818, and 2820 are configured to aid in the angular
orientation and
longitudinal orientation of the catheter and ports 2804, 2806, and 2808. Any
combination
of markings may be used, e.g., more or less may be utilized. The markings may
have
different geometric configurations to also aid with orientations. The markings
may
include an echo genie material, radiopaque material, combination of the same
and the like.
In addition, the catheter may include markings as described with reference to
U.S. Patent
Date recue / Date received 2021-12-07
52
Application Publication 2012/0059308.
[0282] Referring to FIGS. 28B, the distal portion 2800 includes two ports,
2804 and
2808 and at least one marking 2810 positioned immediately proximally adjacent
to the
port 2804. The marking 2804 is utilized to aid in port location and utilized
to position the
port 2804 to a desired treatment situs, e.g., a nerve.
[0283] FIG. 29A illustrates an exemplary view of an apparatus according to
an
embodiment of the invention. FIG. 29B illustrates an exemplary view of a
cannula
according to the apparatus of FIG. 29A.
[0284] Referring to FIGS. 29A-29B, a continuous nerve conduction apparatus
is
generally depicted as reference number 2900. The apparatus 2900 includes a
catheter
2904 and a cannula 2902. The catheter 2904 is over the cannula 2902 and the
cannula
2902 is slidably adapted to move though a lumen (not shown) of the catheter
2904. The
cannula 2902 includes a lumen 2903 extending from a proximal region to a
distal region.
In a preferred embodiment, the lumen 2903 is configured to have a constant
diameter
from the proximal region to the distal region. The cannula 2902 and catheter
2904 may be
constructed to include any features as described herein. Moreover, in one
embodiment the
cannula is described with reference to U.S. Patent Application Publication No.
2011/0112511. The
cannula 2902 may be a Touhy needle, Crawford needle, Hustead Needle, Sprotte
needle,
Whitacrea needle, Quincke needle, or other medical needles. In a preferred
embodiment,
the gauge of the needle is in a range from about 6 to about 26 and more
preferably the
gauge of the needle is in a range from about 18 to about 20.
[0285] The cannula 2902 and/or catheter 2904 include a change of diameter
at a
distal end portion 2908. The distal end portion of the cannula 2902 and/or
catheter 2904
has a smaller diameter than a more proximal region of the cannula 2902 and/or
catheter
2904. In one embodiment, the diameter changes from a larger diameter to a
smaller
diameter gradually at a taper at region 2905. In an alternative embodiment,
the distal
region of the cannula 2902 and/or catheter 2904 has a larger diameter as
compared to a
region more proximal of the cannula 2902 and/or catheter 2904.
[0286] The catheter 2904 includes at least one side port 2906, which is
arranged in
the distal region of the catheter 2904. At least one side port 2906 is
configured to allow a
pharmacologic agent to exit when the end port 2907 is occluded or partially
occluded.
53
Moreover, the side port 2906 may include any geometry or number as described
herein.
In a preferred embodiment, the side port 2906 includes four side ports
arranged along the
same axis of the catheter and uniformly spaced from each other. The distal end
of the
cannula 2902 includes a distal end port 2907 configured to allow a
pharmacologic agent to
exit.
[0287] The change from a larger diameter to a smaller diameter or vice
versa may be
a gradual taper having any type of shape, e.g., a linear taper shape, non-
linear taper shape
or a sharp taper shape. The sharp taper includes angle change from about 85
degrees to
about 95 degrees from a central axis of the catheter. Moreover, the change
from a larger
diameter to a smaller diameter may be at any angle from the central axis of
the catheter in
a range from about 1 degree to about 90 degrees; preferably the taper is at an
angle
ranging from about 25 degrees to about 75 degrees, and more preferably the
taper is at an
angle ranging from about 35 to about 55 degrees.
[0288] The change in diameter size is configured to promote
visualization under
external imaging, e.g., ultrasound imaging or other imaging technology. The
smaller or
larger diameter change allows one to pin-point the change of diameter under
ultrasound
imaging without the need of an echogenic material or other type of
visualization material.
The diameter change may be in a range from about 0.1 gauge to about 5 gauge or
greater,
in a preferred embodiment the diameter change is in a range from about 2 gauge
to about 4
gauge, and in a more preferred embodiment the diameter change is about a 2
gauge
change. In a preferred embodiment, the region of catheter 2905 extending past
the
diameter change is in a range from 0.1 cm to about 4 cm, more preferably in a
range from
0.5 cm to 2 cm, and most preferably in a range from about 1 cm to 1.8 cm.
Moreover, the
location of the lateral port 2906 can be determined as it is placed adjacent
the diameter
change or taper.
[0289] FIG. 29C illustrates an exemplary view of a distal end region
of a catheter
according to the apparatus of FIG. 29A according to another embodiment of the
invention.
FIG. 29D illustrates an exemplary view of a distal end region of a catheter
according to the
apparatus of FIG. 29A according to another embodiment of the invention. FIG.
29E
illustrates an exemplary view of a distal end region of a catheter according
to the apparatus
of FIG. 29A according to another embodiment of the invention.
Date recue / Date received 2021-12-07
54
[0290] Referring to FIG. 29C, the distal end region 2910 of the
catheter 2904
includes a straight portion. The cannula 2902 in this embodiment also includes
a distal
end region being straight, i.e., with no curvature.
[0291] Referring to FIG. 29D, the distal end region of the catheter
2904 includes a
curved region 2912 in a range from about 85 degrees to about 95 degrees. The
cannula
2902 may also have a curved region at distal end region, e.g., in a range from
about 1
degree to about 10 degrees or greater. In this embodiment, the catheter
includes a portion
having a curvature configured as a preformed memory shape as described herein.
[0292] Referring to FIG. 29E, the distal end region of the catheter
2904 includes a
curved region 2914 in a range from about 185 degrees to about 175 degrees. The
curved
region may be configured in a range from about 5 degrees to about 185 degrees.
In
operation, this curved region is configured to provide a radial spread of
local anesthetics
out of one or more side ports 2906 and/or distal end port 2907. Neural
structures arc
frequently cylindrical in shape and by positioning the catheter to cover a
large area of the
neural structure the pharmacological agent as dispensed surrounds a nerve
providing for
more efficacy of the agent. The cannula 2902 may also have a curved region at
distal end
region, e.g., in a range from about 1 degree to about 10 degrees or greater.
[0293] FIG. 30A illustrates a perspective view of a cannula according
to another
embodiment of the invention. FIG. 30B illustrates a top view of a cannula
according to
FIG. 30A. FIG. 30C illustrates an enlarged view of a cannula according to FIG.
30A.
[0294] Referring to FIGS. 30A-30C, a cannula is generally depicted as
reference
number 3000. The cannula 3000 is configured to be inserted through a lumen of
a
catheter. The cannula 3000 includes a shaft 3000 having a lumen extending form
a
proximal end to a distal end. The proximal end is coupled to a hub 3004 and
the distal end
has a Touhy tip needle or other medical needle.
[0295] The gauge of the cannula is in a range from about 10 gauge to
about 26
gauge. In a preferred embodiment, the gauge is in range from about 18 gauge to
about 20
gauge. The length of the cannula can be in a range from about 5 cm to 30 cm or
greater.
In a preferred embodiment, the length of the cannula is one of 7 cm, 15 cm,
and 20 cm.
The hub 3004 includes at least one alignment mark 3006. The alignment mark
3006 may
be any type of notation or markings configured to determine an origination of
a distal end
portion of the cannula 3000. The hub 3004 includes a fitting 3005 configured
to receive a
syringe or other device.
Date recue / Date received 2021-12-07
55
[0296] The cannula 3000 includes a Touhy tip 3008. The Touhy tip 3008
has a
slight curve portion at the end of the shaft 3002. The curved orientation is
indicated by the
alignment mark 3006. In this embodiment, the alignment mark 3006 is an arrow
which
indicates the curved portion of the Touhy tip is coming out of the page.
[0297] FIG. 31A illustrates a cross-sectional view of a cannula
according to another
embodiment of the invention. FIG. 31B illustrates a distal end view of the
cannula of FIG.
31A. FIG. 31C illustrates an exploded view of a hub of FIG. 31A.
[0298] Referring to FIG. 31A, the cannula is generally depicted as
reference number
3100. The cannula 3100 includes a shaft 3102 and is configured to be inserted
through a
lumen of a catheter. The cannula 3100 includes a shaft 3102 having a lumen
extending
form a proximal end to a distal end. The proximal end is coupled to a hub 3104
and the
distal end has a Touhy tip 3106 or is configured as another needle as
described herein.
The hub 3104 includes at least one alignment mark (not shown). The cannula is
configured to stimulate a nerve as known in the art. A conductive element 3108
is
configured to transmit electrical activity used to activate a nerve via the
cannula shaft
3102 to a distal portion of the catheter 302 and cannula 304. In a preferred
embodiment,
the electrical activity is generated by a nerve stimulator generator (not
shown), e.g.,
Stimuplex LINS11 Peripheral Nerve Stimulator by B. Braun, Stimuplex Dig RC by
B.Braun, MultiStim VARIO by Pajunk, and EzStim0 stimulator by Life-Tech
International. In a preferred embodiment, the embedded conductive element 314
is an
embedded wire.
[0299] Referring to FIGS. 31B and 31C, the hub 3104 is constructed
from a
proximal hub portion 3101, a conductive element 3108, and a distal hub portion
3103.
The conductive element 3108 is an integral unit or solid unit formed from a
conductive
material. The conductive material is constructed from a conductive material.
The
conductive element 3108 includes a first tab 3105 and a second tab 3107
coupled to a
cylindrical unit 3109. The proximal hub portion 3101 abuts the first tab 3105
and second
tab 3107 and the distal hub portion 3103 abuts the first tab 3101, second tab
3105 and
covers a proximal hub portion 3101.
[0300] In one embodiment, the conductive element 3108 and is formed
from a single
mold unit. The cylindrical unit 3109 includes a lumen configured to receive
the cannula
shaft 3102. Optionally, the first tab 3105 and second tab 3207 includes one or
more holes
(not shown) for acceptance of a clip of the nerve stimulator attachment
mechanism. The
Date recue / Date received 2021-12-07
56
shaft 3102 also includes an electrically insulated portion 3111 formed with an
insulating
coating such as thermoplastic coating.
[0301] The alignment mark includes any type of notation or markings
configured to
determine an origination of a distal end portion of the cannula 3100. In this
embodiment,
the Touhy tip 3106 has a slight curve portion at the end of the shaft 3102.
The curved
orientation of the Touhy tip is indicated by the alignment mark such as an
arrow. The
arrow which indicates the curved portion of the Touhy tip is coming out of the
page. The
gauge of the cannula is in a range from about 10 gauge to about 26 gauge. In a
preferred
embodiment, the gauge is in range from about 18 gauge to about 20 gauge. The
length of
the cannula can be in a range from about 5 cm to 30 cm or greater. In a
preferred
embodiment, the length of the cannula is one of 7 cm, 15 cm, and 20 cm.
[0302] FIG. 32A illustrates an exemplary view of a catheter according
to another
embodiment of the invention. FIG. 32B illustrates an enlarged view of section
B-B of the
catheter of FIG. 32A. FIG. 32C illustrates an enlarged cross-sectional view of
a distal
portion of the catheter of FIG. 32A. FIG. 32D illustrates an end view of the
catheter of
FIG. 32A. FIG. 32E illustrates an enlarged view of a hub according to the
catheter of FIG.
2A.
[0303] Referring to FIGS. 32A-32E, a catheter is generally depicted as
reference
number 3200. The catheter 3200 includes a hub 3202 on a proximal portion, a
shaft 3204
and one or more lateral ports 3206 on a distal portion. The shaft 3204 further
includes
markings 3208 configured to indicate the length the catheter. The markings
3208 are
configured at predetermined increments in a range from about 1 cm to about 1
cm to about
cm or greater.
[0304] The hub 3202 includes a first tab 3210 and a second tab 3212
configured to
be adhered to a portion of a patient. The first tab 3210 and the second tab
3212 include an
adhesive on side configured to adhere to a patient. The adhesive may include a
removable
portion protecting the adhesive prior to first use. A distal end of the
catheter includes a
taper at an angle of about thirty degrees relative to a central axis. The
catheter may
optionally be reinforced with a secondary material in order to increase
stiffness of the
catheter and substantially prevent kinking. The reinforcement may be
constructed from a
metal, polymer, thermoplastic and combinations of the same.
[0305] The shaft 3204 includes a plurality of lateral ports 3206
arranged at a distal
end portion of the catheter. The spacing between adjacent lateral ports are
uniformly
Date recue / Date received 2021-12-07
57
spaced and offset from each other at an angle around a circumference of the
shaft 3204. In
this embodiment, the angle between lateral ports is about 120 degrees as shown
in FIG.
32D. The diameter of each lateral port may be identical to an adjacent lateral
port. The
diameter is in a range from about 0.005 inches to about 0.05 inches or
greater. Optionally,
the hub 3202 includes an alignment mark 3216 configured to show an orientation
of the
lateral port. In one embodiment, there may be a plurality of alignment marks
on the hub
where each alignment mark is configured to depict the orientation of each
lateral port,
respectively.
[0306] FIG. 33 illustrates an exemplary view of a catheter according
to another
embodiment of the invention.
[0307] Referring to FIGS. 33, a catheter is generally depicted as
reference number
3300. The catheter 3300 includes a hub 3302 on a proximal portion of a shaft
3304 and
one or more lateral ports 3306 on a distal portion of the shaft 3304. The
shaft 3304 further
includes markings 3308 configured to indicate the length the catheter as
described herein.
The hub 3302 includes a first tab 3310 and a second tab 3312 configured to be
adhered to
a portion of a patient. The first tab 3310 and the second tab 3312 are
described herein.
[0308] The catheter includes a curved portion 3314 on the distal
portion of the shaft
3304. The curved portion is preformed into the catheter as a memory shape.
When a
cannula is in the catheter the catheter distal end is straight and upon
removal of the
cannula the catheter is curved to the preformed shape. The shape of the curve
may be at
any angle as described herein. In a preferred embodiment, the curvature has a
radius of
about 0.5 inches.
[0309] FIG. 34A illustrates a top view of a continuous anesthesia
nerve conduction
apparatus according to another embodiment of the invention. FIG. 34B
illustrates a
bottom view of a continuous anesthesia nerve conduction apparatus according to
FIG.
34A. FIG. 34C illustrates a cross-sectional view of the continuous anesthesia
nerve
conduction apparatus according to FIG. 34A.
[0310] Referring to FIGS. 34A-34C, the apparatus is generally depicted
as reference
number 3400. The apparatus 3400 includes a cannula 3402 and a catheter 3404.
The
cannula 3402 and hub 3408 are described with detail with respect to FIGS. 31A-
31C.
The cannula 3402 is arranged through a lumen of a catheter 3404. The cannula
3402
includes a shaft 3406 having a lumen coupled to a hub 3408 and at least one
alignment
mark 3410 configured to indicate the orientation of a curvature of a distal
end of the
Date recue / Date received 2021-12-07
58
cannula as described herein. The hub 3408 includes a conductive element 3412
configured to be attached to a nerve stimulator as described herein.
[0311] The catheter 3404 is described in further detail with regard to
FIGS. 32A-
32C. The catheter 3404 includes a hub 3414 on a proximal portion of a shaft
3416 and
one or more lateral ports 3418 on a distal portion of the catheter 3402. The
shaft 3416 of
the catheter 3402 includes markings 3420 configured to indicate the length the
catheter.
The hub 3414 includes at least one alignment mark 3426 configured to indicate
the
orientation of a lateral port 3418 as described herein.
[0312] The hub 3408 of the cannula 3402 and hub 3414 of the catheter
3404 are
configured to fit together in substantially locked configuration such that
there is
continuous lumen extending between and through both hubs. The locked
configuration
substantially prevents individual rotation of either the catheter 3404 or
cannula 3402,
thereby allowing the catheter and cannula to be utilized as one unit. In an
alternative
embodiment, the portion where the hubs are in contact with each include male
and female
notches arranged at predetermined orientations on respective contact surfaces
of the hubs.
These notches may be arranged in a circular pattern along an axis of the hub
at various
degrees, e.g., 30 degrees, 60 degrees, 90 degrees, 120 degrees, 150 degrees,
and 180
degrees. The notches are configured to permit offset rotation of the catheter
relative to the
cannula at each predetermined orientation. When the male and female notches
are
engaged the catheter and cannula are in substantially locked configuration.
[0313] The hub 3414 includes a first tab 3422 and a second tab 3424
configured to
be adhered to a portion of a patient. The first tab 3422 and the second tab
3424 include an
adhesive on side configured to adhere to a patient. The adhesive may include a
removable
portion protecting the adhesive prior to first use. The end of the catheter
includes a taper
at about 30 degrees. The catheter may optionally be reinforced with a
secondary material,
e.g., metal, polymer, thermoplastic and the like in order to increase
stiffness.
[0314] FIG. 35A illustrates a perspective view of an extension set
according to
another embodiment of the invention. FIG. 35B illustrates a side view of the
extension
set of FIG. 36A.
[0315] Referring to FIGS. 35A-35B, the extension unit is generally
depicted as
reference number 3500. The extension unit 3500 includes a fitting 3502 coupled
to a
tubing 3506 coupled to another fitting 3510. The fittings of this embodiment
may include
a luer connector, e.g., a male luer connector, female luer connector, and/or
luer-lock
Date recue / Date received 2021-12-07
59
connector. In a preferred embodiment, the fitting 3502 is luer lock male cap
connector
configured to be releasably coupled to a hub of a catheter and/or cannula,
e.g., catheter
hub 3414 or cannula hub 3408. A flexible tubing 3506 is connected to the
fitting 3502 and
a male luer connector 3510.
[0316] The fitting 3502 and/or tubing 3506 includes a first tab 3502
and a second tab
3504 configured to be adhered to a portion of a patient. The first tab 3502
and the second
tab 3504 include an adhesive on one side configured to adhere to a patient.
The adhesive
may include a removable portion protecting the adhesive prior to first use.
The fitting
3510 and/or tubing 3506 also include a label 3508. In a preferred embodiment,
the label
3508 is a warning label to indicate the type of catheter such as a nerve
catheter versus an
intravenous (iv) catheter. The label 3508 and tabs 3504 are integral or built
into the
extension set 3500. The length of the tubing is no more than about five inches
and in
preferred embodiment about three inches in length. This short tubing length
provides for
an enhanced ease of use and minimizes contamination, thereby allowing a user
to operate
the system with one handed operation.
[0317] FIG. 36A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention. FIG.
36B
illustrates a graph of an interference fit according to the apparatus of FIG.
36A.
[0318] Referring to FIGS. 36A-36B, the apparatus is generally depicted
as reference
number 3600. The apparatus 3600 includes a catheter 3602 and cannula 3604. A
distal
portion of the catheter may have a curvature or no curvature as described
herein. The
cannula 3604 may include a Touhy tip or other needle as described herein. In
this
embodiment, the catheter 3602 has a lumen extending from proximal portion to a
distal
end. The distal portion of the catheter may also include side ports (not
shown) as
described herein. An inside diameter of the lumen of the catheter 3602
decreases along a
distal portion to the catheter as shown in FIG. 36B. This decrease allows for
a resistant fit
or interference fit of the cannula 3604, thereby requiring the user to apply
an increased
force to extend the cannula 3604 out a distal end of the catheter 3602. The
decrease of the
inside diameter may be linear, non-linear or any combination of the same.
[0319] Referring to FIG. 36B, the graph includes the diameter of an
inside diameter
3608 of a lumen of the catheter and outside diameter 3610 of the cannula on an
x-y graph.
The x-axis of the graph depicts a length [cm] of the catheter 3602 and/or
cannula 3604 and
the y-axis of the graph depicts a diameter [cm]. As shown, the inside diameter
3608 of
Date recue / Date received 2021-12-07
60
the lumen of the catheter 3602 decreases as it approaches a distal end portion
of the
catheter 3602. The outside diameter 3610 of the cannula is static or constant
as shown in
the graph. In one embodiment, the distance delta 3612 between the inside
diameter of the
catheter lumen and outside diameter of the cannula is in a range from about
0.1 mm to
about 0.0001 mm. In a preferred embodiment, the distance delta is less than
about 0.5 mm
and may be about 0 mm.
[0320] This embodiment produces an interference fit between the
cannula and the
catheter, thereby permitting the cannula and the catheter to act as one solid
unit when
used. In one embodiment, the materials of the catheter include a thermoplastic
material
that allows for some expansion to add in the interference fit. This
interference fit is
configured to minimize or eliminate any gap to between the distal end or
distal end
portions of the cannula and the inside diameter of the catheter, thereby
minimizing the
probability that the catheter compresses, bunches, and/or snags upon tissue of
a patient. In
a preferred embodiment, the distal most portion of the catheter is angled or
beveled as
described with reference to FIG. 32B.
[0321] FIG. 37A illustrates a perspective view of a continuous
anesthesia nerve
conduction apparatus according to another embodiment of the invention. FIG.
37B
illustrates a catheter according to another embodiment of the invention. FIG.
37C
illustrates an anti-restriction member according to another embodiment of the
invention.
[0322] Referring to FIGS. 37A-37C, the apparatus includes a cannula
3702, a
catheter 3704, and an anti-restriction member 3706. The anti-restriction
member 3706 is
configured to be inserted into a lumen of the catheter 3704. The anti-
restriction member
3706 is conductive such that it can be used as a nerve stimulator. Optionally,
a portion of
the member 3706 is insulated with a coating (not shown).
[0323] In this embodiment, the catheter 3704 includes a hub 3708 and a
flexible
tubing 3710 having a lumen that extends from a proximal end to a distal end.
The lumen
is configured to deliver a pharmacological agent to a desired treatment situs.
The flexible
tubing 3710 can kink or bend, thereby preventing fluid flow through the lumen.
The
flexible tubing 3710 includes one or more lateral ports 3712 at distal end
portion of the
catheter 3704. In one embodiment, the hub 3708 includes an alignment mark
configured
to show the orientation of the lateral port 3712 as described herein.
[0324] The cannula 3702 includes a shaft 3714, a hub 3716, a
conductive connector
3718 and an alignment mark (not shown) as described with reference to FIGS.
31A-31C
Date recue / Date received 2021-12-07
61
and related text. The cannula 3702 is configured to be inserted into the
catheter 3704.
Both the cannula 3702 and the catheter 3704 are configured to be inserted into
a patient as
a single unit. The catheter 3702 and the cannula 3704 may be configured with
an
interference fit as described with reference to FIG. 36A-36B and related text.
[0325] After insertion the cannula 3702 is removed from the catheter
3704.
Optionally, an anti-restriction member 3706 may be inserted into the catheter
3704. The
anti-restriction member 3706 includes a hub 3722, a stimulation attachment
3724, and a
fitting 3725. The anti-restriction member 3706 includes an element 3726 that
enables
fluid flow to continue through the lumen of the catheter 3704 when inserted.
In addition,
the element 3726 is configured to prevent kinking of the catheter and provide
patency of
the lumen catheter 3704. In this embodiment, the element 3726 is constructed
from a
conductive material and into a geometric configuration to preserve patency of
the lumen of
the catheter 3704.
[0326] The geometric configuration can include a helix braided wire, a
spiral laser
cut hypo-tube, a stent like structure and combinations of the same. Should
kinking or
bending occur when the anti-restrictive member 3706 is positioned in the
catheter 3704 the
element 3728 can act as a flow element to allow fluid to flow even upon
kinking or
bending of the catheter and element 3728.
[0327] In this embodiment, when the element 3726 is configured to be
used as a
nerve stimulator, the element 3726 is sized such that a distal most portion of
the element
3726 extends past a distal end of the catheter 3704. Moreover, tabs 3722, 3724
on the hub
3725 are configured to be attached to a nerve stimulator. The hub 3725 is also
configured
with a fitting 3725. The fitting 3725 can include a luer connector, e.g., a
male luer
connector, female luer connector, and/or luer-lock connector. In a preferred
embodiment,
the fitting 3725 is configured to be releasably attached to a syringe and/or a
tubing of a
pump.
[0328] FIG. 37D illustrates a catheter according to another embodiment
of the
invention.
[0329] Referring to FIG. 37D, a catheter is generally depicted as
reference number
3728. The catheter 3728 includes a rigid shaft 3730 having a lumen extending
from
proximal end to a distal end and the shaft 3730 and is coupled to a hub 3732.
The catheter
3728 does not include any lateral ports and is configured to be inserted into
a lumen of the
Date recue / Date received 2021-12-07
62
catheter 3704, thereby strengthening the shaft 3710 of the catheter 3704 and
also
configured to prevent kinking and/or bending of the catheter.
[0330] The catheter 3728 includes a hub 3732 with a connector 3735.
The lumen of
the catheter 3728 is configured to deliver a pharmacological agent to a
desired treatment
situs. The length of the catheter shaft 3730 is sized to be shorter than the
distal end of the
catheter shaft 3710 and shorter than lateral port 3712. Optionally, one or
more
predetermined portions of the catheter 3730 can include a visualization
enhancement. The
visualization enhancement may include an echogenic material arranged at a
predetermined
location of the shaft and in a predetermined pattern as described herein.
[0331] FIG. 37E illustrates a catheter according to another embodiment
of the
invention.
[0332] Referring to FIG. 37E, a catheter is generally depicted as
reference number
3734. The catheter 3734 includes a rigid shaft 3736 having a lumen extending
from
proximal end to a distal end and the shaft 3736. The shaft 3736 is coupled to
a hub 3738.
The catheter 3734 includes lateral ports 3740. The catheter 3734 is also sized
to be
inserted into a lumen of the catheter 3704, thereby strengthening the shaft
3710 of the
catheter 3704 and substantially preventing kinking and/or bending of the
catheter 3704.
[0333] The catheter shaft 3736 includes a hub 3738 with a fitting
3737. The lumen
of the catheter 3734 is configured to deliver a pharmacological agent to a
desired
treatment situs when in use. The length of the catheter shaft 3736 is sized to
be longer
than the distal end of the catheter 3704. In a preferred embodiment, the
length of the
catheter 3734 is sized such that the lateral ports 3740 extend immediately out
the distal
end of the catheter 3704. A distal end of the catheter 3734 can include a
visualization
enhancement at a desired location. The visualization enhancement may include
an
echo genie material arranged at a predetermined location of the shaft and
predetermined
pattern as described herein.
[0334] FIG. 37F illustrates a catheter according to another embodiment
of the
invention.
[0335] Referring to FIG. 37F, a catheter is generally depicted as
reference number
3742. The catheter 3742 includes a rigid shaft 3746 having a lumen extending
from
proximal end to a distal end of the shaft 3746. The shaft 3746 is coupled to a
hub 3743.
The catheter 3742 includes lateral ports 3748 and is sized to be inserted into
a lumen of the
Date recue / Date received 2021-12-07
63
catheter 3704, thereby strengthening the shaft 3710 of the catheter 3705 and
substantially
preventing kinking and/or bending of the shaft 3710.
[0336] The catheter 3742 includes a hub 3743 with a fitting 3739. The
lumen of the
catheter 3742 is configured to deliver a pharmacological agent to a desired
treatment situs.
The length of the catheter shaft 3746 is sized to be longer than the distal
end of the
catheter 3704. In a preferred embodiment, the length of the catheter 3742 is
sized such
that lateral ports 3748 extend immediately out a distal end of the catheter
3704. A distal
end of the catheter 3742 can include a visualization enhancement material at a
desired
location. The visualization enhancement material may include an echogenic
material
arranged at a predetermined location of the shaft and arranged in
predetermined patterns.
The distal end of the catheter 3742 includes preformed curvature as described
herein.
[0337] FIG. 37G illustrates a catheter according to another embodiment
of the
invention.
[0338] Referring to FIG. 37G, a catheter is generally depicted as
reference number
3750. The catheter 3750 includes a rigid shaft 3752 having a lumen extending
from
proximal end to a distal end of the shaft 3752. The shaft 3752 is coupled to a
hub 3753.
The catheter 3750 includes lateral ports 3754 and is sized to be inserted into
a lumen of the
catheter 3704, thereby strengthening the shaft 3710 of the catheter 3704 to
substantially
prevent kinking and/or bending of the shaft 3710.
[0339] The catheter 3750 includes a hub 3753 including a fitting 3741.
The hub
3753 also includes a conductive element 3745. The conductive element 3745 is
formed
from a single mold unit as described herein. A conductive wire or element not
shown
extends down a catheter shaft 3752 as described herein with reference to FIG.
3B. The
catheter 3750 includes a conductive end portion, e.g. cap. The catheter is
used as a
stimulating catheter configured to stimulate a nerve and extend out a distal
end of the
catheter 3704.
[0340] The length of the catheter shaft 3752 is sized to be longer
than the distal end
of the catheter 3704. In a preferred embodiment, the length of the catheter
3750 is sized
such that the lateral ports 3756 extend immediately out the distal end of the
catheter 3742.
Optionally, a distal end portion of the catheter 3742 can include a
visualization
enhancement material at a desired location. The visualization enhancement
material may
include an echogenic material arranged at a predetermined location of the
shaft and
Date recue / Date received 2021-12-07
64
predetermined pattern as described herein. The distal end of the catheter may
also include
preformed curvature as described herein.
[0341] FIG. 38 illustrates a medical device kit according to another
embodiment of
the invention.
[0342] Referring to FIG. 38, a kit is generally depicted as reference
number 3800.
The kit 3800 is configured to hold an apparatus and associated medical
surgical items
described herein. In this embodiment, the kit 3800 includes a thermo formed
mold
constructed from a thermoplastic material. The mold has a plurality of
recessed slots to
receive various components of the kit. The kit and the components are
sterilized to
comply with governmental medical standards, e.g., U.S. Food and Drug
Administration
(FDA) standards. A protective sterile plastic film covers and seals the kit.
[0343] The kit 3800 includes a first needle 3802 having first size, a
second needle
3804 having a second size smaller than the size of the first needle, a first
syringe 3806, a
label (not shown), a steri-strip 3810, a tegaderm patch 3812, a filter 3814,
an electrical
connector 3816, a second syringe 3818 smaller than the size of the first
syringe 3806, an
extension set 3820 as described with reference to FIGS. 35A-35B, and an
apparatus and
cannula described according to any of the embodiments herein.
[0344] Described next is a method of administrating a pharmacological
agent in
accordance with another embodiment of the invention. This embodiment will be
described
with reference to the continuous anesthesia nerve conduction apparatus
described herein
FIGS. 3A-3C. However, any apparatus described herein may be used with this
procedure.
[0345] Advantageously, the method of administering the pharmacological
agent in
accordance with the invention does not need to occur in a fully sterile
environment and is
much faster than the traditional methods of administrating a pharmacological
agent. In
addition, the operator can perform the method by herself without requiring
assistance from
another person.
[0346] Initially, preparatory steps are performed prior to performing
a procedure.
These steps include applying non-sterile gloves on both hands and opening
sterile
packaging kit 3800 of the apparatus 302. Next, a cannula 304 is positioned
through the
lumen 326 of the catheter 302, and the cannula 304 is secured to the hub of
the catheter
302 via locking mechanism 322. In an embodiment, each of the items used during
the
procedure are provided in a sterile kit. In another embodiment, each item used
during the
procedure is preassembled in the kit.
Date recue / Date received 2021-12-07
65
[0347] A syringe (not shown) is connected to the cannula hub 320. A
distal portion
of the catheter 302 is maintained in a sterile manner within its covering. The
proximal
portion of the catheter 302 and cannula 304 are exposed so that a standard
syringe filled
with a liquid solution is coupled to the hub 320.
[0348] Next, a patient is positioned according to the type and
location of nerve(s) to
be targeted as known in the art. The operative portion of the patient
(insertion site) is
prepped with an antiseptic solution. If a peripheral nerve stimulator is being
used, the
peripheral nerve stimulator is connected to the exposed proximal end of the
apparatus via
an electrode connector 316 on the proximal hub of the catheter 302. The
necessary
connection for the peripheral nerve stimulator to the patient is also
performed and the
nerve stimulator is activated for the appropriate setting as known in the art.
[0349] An ultrasound probe is held in the non-operative hand and
positioned on the
patient to obtain an image of the targeted nerve(s). Once the ultrasound probe
is in
position, the insertion site for the apparatus including a cannula 304 and
catheter 302
(combined apparatus) can be ascertained and a skin wheal is raised to
anesthetize the
insertion site.
[0350] With the other hand (operative hand), the combined apparatus is
slipped out
of the sterile covering and inserted through the insertion site. The distal
tip of the
combined apparatus is then advanced towards the targeted nerve(s) under direct
visualization via the ultrasound image.
[0351] If nerve stimulation is used, the distal tip of the combined
apparatus is
advanced towards the targeted nerve(s) until the appropriate muscle
stimulation is
obtained for confirmation that the distal tip of the apparatus is positioned
in proximity to
the targeted nerve(s). Once adjacent to the targeted nerve(s), the solution in
the standard
syringe that was previously attached to the proximal hub of the introducing
cannula 304 is
injected to hydro-dissect the tissue surrounding the targeted nerve(s). Real
time
ultrasound visualization is possible because the non-operative hand is
simultaneously
positioning the ultrasound probe to obtain a view of the targeted nerve(s) and
while
positioning the distal portion of the inserted apparatus with the operative
hand.
[0352] Once the tissue surrounding the nerve(s) is expanded with the
solution in the
syringe, the proximal hub 306 of the catheter is released from the hub lock
322 on the
proximal hub 320 of the introducing cannula 304 with the operative hand. The
catheter
302 is then advanced with a finger of the operative hand while the introducing
cannula 304
Date recue / Date received 2021-12-07
66
is withdrawn from the lumen of the catheter 302 with the operative hand, much
like
advancing an intravenous catheter off the needle and into a blood vessel. This
is done
simultaneously while maintaining an ultrasound image of the distal portion of
the catheter
302 and the targeted nerve(s) with the non-operative hand
manipulating/managing the
ultrasound probe. If the catheter's distal tip is not able to extend into its
preformed shape
due to tissue obstruction, a guidewire can be positioned through the lumen of
the cannula
to aid the directional positioning of the catheter tip.
[0353] With the catheter 302 positioned adjacent to the targeted
nerve(s), and the
introducing cannula 304 withdrawn, another syringe with local anesthetic
solution is
connected to the proximal hub of the catheter that is exteriorized on the
patient, and local
anesthetic can be injected via the catheter alone, while again being
visualized in real-time
with the ultrasound imaging maintained by the non-operative hand. Once
placement of
the distal tip of the catheter 302 and local anesthetic spread is confirmed by
ultrasound
imaging, the ultrasound probe and/or the peripheral nerve stimulator can be
set aside.
[0354] The syringe can then be disconnected from the catheter 302, and
the proximal
hub 306 of the catheter 302 is secured to the patient's skin with adhesive
tape applied to
the hub and wings 308, 310. The hub can then be capped or connected to an
infusion
pump via a connecting tube. The externalized portion of the catheter 302 and
hub 306 can
be covered with a clear dressing to further minimize dislodgement, and
maintain sterility.
[0355] These steps can be accomplished by one proficient in the arts
in
approximately the same time or less than it takes to perform a single-
injection nerve block
with a needle alone. The approximate time from positioning the patient
(according to the
type and location of nerve(s) to be targeted as known in the art) to securing
and dressing
the hub can take less than 10 minutes. In a preferred embodiment, the
procedure takes less
than 10 minutes to perform.
[0356] Another embodiment of the invention includes a kit for the
delivery of a fluid
to a nerve bundle of a patient. The kit includes a pump, a length of tubing
securable to
said pump, an introducer, and a catheter. The introducer is configured to fit
within the
catheter. The pump, tubing, catheter and introducer are provided together as a
kit. Other
items may also be provided in the kit, e.g., guidewire and stimulator.
[0357] Without intending to limit the scope of the invention, the
following examples
illustrate how various embodiments of the invention may be made and/or used.
EXAMPLES
Date recue / Date received 2021-12-07
67
[0358] The following examples illustrate the time to insert a
catheter, secure the
catheter and dress the patient using the method described herein (Example 1)
as compared
to the traditional method (Example 2).
[0359] Table 1 illustrates a timed comparison between the steps and
method duration
of Example 1, the method described herein, and steps and method duration of
Example 2,
the traditional method. Each step is described in detail below. All time
listed in Table 1
are approximate.
Example 1:
[0360] Examples 1 and 2 are directed towards a medical procedure for
inserting a
catheter for delivering a pharmacological agent to a nerve bundle in the neck
of a
patient. The method in each example generally included three broad steps: Step
1 ¨ Setup;
Step 2 ¨ Procedure; and Step 3 - Securing Catheter. Example 1 was conducted
with an
apparatus according to embodiments of the invention. Example 2 was conducted
with a
needle over catheter apparatus and the procedure to insert the needle over
catheter
apparatus.
[0361] Step 1: (Setup): The operator opened a single sterile device
package, which
included supplies such as a Terumo 2.5 inch 18 gauge Surflo(R) I.V. Catheter.
FIG. 39
illustrates items used in the procedure of Example 1. With reference to FIG.
39, these
items include (starting from the top left of FIG. 39 and proceeding counter-
clockwise)
tubing (white package partially open) 3902, 5cc syringe 3904 containing
medication to
sedate the patient, 3cc syringe 3906 with a 25 gauge 1.5 inch needle attached
to the
syringe which contained Lidocaine, a 20cc syringe 3908 with Ropivicaine,
another 20cc
syringe 3910 which contained Ropivicaine with an angiocath attached to the
syringe
within a cover (the angiocath is an 18 gauge 2.5 inch needle within an 18
gauge 2.5 inch
catheter, where the needle extends just past the tip of the catheter), a
package of Betadine
swabs 3912, securing strips 3914, a tacky substance 3916 to attach the
securing strips and
a clear dressing 3918. The operator put on non-sterile gloves and filled the
syringes. The
local area on the patient where the angiocath was inserted was prepared by
swabbing the
area with Betadine as illustrated in FIG. 40. The operator put the ultrasound
probe in the
vicinity of the nerve bundle. The ultrasound probe contained a small amount of
gel
applied to the tip of the probe. The probe was used to monitor the area
surrounding the
nerve bundle throughout the procedure.
Date recue / Date received 2021-12-07
68
[0362] Step 2: (Procedure): The operator obtained an ultrasound image
of the area,
and then anesthetized the skin and subcutaneous area with the 3cc syringe
filled with
Lidocaine as illustrated in FIG. 41. The 1.5 inch needle attached to the 3cc
syringe
extended to the nerve bundle, which was monitored using the ultrasound image.
The 1.5
inch needle was withdrawn from the patient and set aside. The operator picked
up the
20cc syringe of Ropivicaine with the angiocath attached and slipped off the
housing. The
operator inserted the angiocath into the patent and directed the angiocath to
the nerve
bundle using the needle of the angiocath until the angiocath was near the
nerve bundle,
which was monitored using an ultrasound image as illustrated in FIG. 42. Once
the
operator reached the nerve bundle, the operator hydrodissected the tissue
surrounding the
nerve bundle using the Ropivicaine in the 20cc syringe while monitoring the
tissue
surrounding the nerve bundle with an ultrasound image as illustrated in FIG.
43. The
operator put their finger on the tip of the catheter hub and removed the
needle while the
catheter was advanced. The needle, which was connected to the syringe, was
removed
from the catheter with one hand, while the position of the catheter was
monitored using an
ultrasound image as illustrated in FIG. 44. The operator set down the empty
20cc syringe,
which was still attached to the needle, and picked up the second 20cc syringe
which
contained Ropivicaine and connected the syringe to the catheter hub and
injected about
20cc of Ropivicaine into the patient through the catheter as illustrated in
FIG. 45. This
injection of Ropivicaine verified the catheter position and effectiveness. The
operator
removed and set aside the second syringe from the catheter hub and removed and
set aside
the ultrasound probe. The operator attached the tubing to the catheter hub as
illustrated in
FIG. 46.
[0363] Step 3: (Securing the Catheter): The catheter and tubing were
secured to the
patient with adhesive strips with the tacky substance and clear dressing was
applied as
illustrated in FIG. 47.
Comparative Example 2:
[0364] Step 1: (Setup): The operator opened the package that contained
an Arrow
StimuCath Continuous Nerve Block Procedure Kit. The kit was double wrapped.
The
operator put on sterile gloves and filled the syringes. The operator set up
the ultrasound
probe and filled the sterile sleeve with gel. The operator placed the probe
into the sterile
sleeve and secured the sleeve to the ultrasound probe. The operator attached
the PNS.
The operator draped the patient and prepared a large area surrounding the
injection site.
Date recue / Date received 2021-12-07
69
[0365] Step 2: (Procedure): The operator obtained an ultrasound image
of the area,
and anesthetized the skin and subcutaneous. The operator inserted the needle
into the
patient and hydro-dissected the surrounding tissue. The operator then blindly
advanced
the catheter through the needle with both hands, while trying to maintain
stimulation of the
nerve and advance the catheter. As the needle was backed out from its position
in the
patient, the catheter was advanced. Once the operator believed the catheter
was in place,
the operator took another scan of the area with the ultrasound probe, which
was put aside
in order to advance the catheter. Before the operator injected a
pharmacological agent
through the catheter, the operator attached a connector hub to the catheter.
After the hub
was attached, the tubing was attached.
[0366] Step 3: (Securing Catheter): Excess length of the catheter was
coiled and
the catheter was secured to the patient using adhesive strips. Clear dressing
was applied to
the patient.
Tablet : Comparison Table of Example 1 and Comparison Example 2
Device Terumot 2.5 inch 18 gauge Arrow StimuCath
Surflo0 I.V. Catheter Continuous Nerve Block
Procedural Kit
Step 1 Setup:
Opening of packaging and 00:05 01:00
supplies Single sterile device in Double wrapped
sterile kit
package
Gloving 00:10 01:00
Non-sterile gloves Sterile gloves
Filling Syringes 00:30 00:30
Drawing up syringes Drawing up syringes
from kit
US Probe setup 00:05 02:30
Apply non-sterile gel Fill sterile sleeve
with gel
Place probe into sterile sleeve
Secure sleeve to probe
Attach PNS n/a 00:30
Prep and Drape 00:05 01:00
Betadine swabs ¨ no draping Wide sterile prep with
sterile
draping
Step 2 Procedure:
Obtaining first US image 00:30 00:30
Anesthetize skin and SQ 00:15 00:15
Insertion of needle and 00:15 00:15
catheter system
Hyrodissecting of surrounding 00:30 ¨ 02:00 00:30 ¨ 02:00
tissue (variable) (variable)
Positioning catheter 00:05 01:00 ¨ 10:00
(variable)
Catheter advanced off of Blind advancement of
catheter
Date recue / Date received 2021-12-07
70
needle through needle with
both
hands
Trying to maintain stimulation
while advancing catheter
Removal of needle n/a 00:30
Needle withdrawn when Needle is backed out
while
catheter was positioned advancing catheter
Rescan for image n/a 00:30
US image maintain at all times Need to rescan since probe
was put aside to advance
catheter
Inject through catheter 00:30 01:00
Large bore with low resistance Need to attach connector hub
Long catheter with high
resistance
Attach tubing to catheter 00:15 00:30
Tubing connected directly to Need to attach hub and
catheter hub connect tubing
Step 3 Securing Catheter:
Secure catheter and apply 00:15 00:30
dressing Adhesive strips and clear Coiling extra
catheter length
dressing Adhesive strips and
clear
dressing
Total time (minutes) 03:30 ¨ 05:30 12:00 ¨ 24:00
[0367] Important distinctions exist between Example 1 and Example 2.
Notably,
Example 1 is performed by a single clinician. Example 2 requires an assistant
simply due
to the fact that the operator, equipment and supplies must maintain sterility
with the
traditional method. Furthermore, the setup and method explained in Example 2
requires
that all necessary equipment and supplies are handled in a sterile fashion. If
any aspect of
the method is accidently contaminated, a sterile replacement for the equipment
and
supplies will be required, which frequently necessitates a new set up.
[0368] The steps illustrated in Example 1 are more precise and easily
performed by
an operator. Example 1 does not require draping or preparation of a large area
on the
patient, rather no draping is required and only a small portion of the patient
is prepared.
Furthermore, the ultrasound imager is maintained throughout the procedure in
Example 1
as opposed to Example 2. The operator in Example 2 only regains the ultrasound
image of
the patient after the needle has been removed. Positioning the catheter as
illustrated in
Example 2 is highly variable with regard to time. It is rare that the catheter
is in the
correct position on the first attempt. More typically, the catheter and quite
often the needle
require repositioning which can take considerable time since real-time
ultrasound imaging
Date recue / Date received 2021-12-07
71
is not available to the operator. Furthermore, if the catheter is misplaced,
then the operator
may have to remove the catheter and start over with a new sterile kit.
[0369] Compared to the traditional method (Example 2), the method and
device
described herein using a catheter that allows for an internal introducer can
result in
approximately 70% to 80% savings in time. This estimate is conservative and
does not
take into consideration the time to reposition the catheter and needle if
required, which is
likely using the traditional method.
[0370] The inventions and methods described herein can be viewed as a
whole, or as
a number of separate inventions, that can be used independently or mixed and
matched as
desired. All inventions, steps, processes, devices, and methods described
herein can be
mixed and matched as desired. All previously described features, functions, or
inventions
described herein or by reference may be mixed and matched as desired.
[0371] It will be apparent to those skilled in the art that various
modifications and
variations can be made in the present invention without departing from the
spirit or scope
of the invention. For example, the cannula has a distal end that may include a
sharp tip, a
short beveled tip, and/or a Touhy tip. Thus, it is intended that the present
invention cover
all of the modifications and variations of this invention provided they come
within the
scope of the appended claims and their equivalents.
Date recue / Date received 2021-12-07
