U.S. patent application number 16/380745 was filed with the patent office on 2019-08-01 for bioadhesive delivery catheter manifold with mixing fixture and methods.
This patent application is currently assigned to ST. JUDE MEDICAL PUERTO RICO LLC. The applicant listed for this patent is ST. JUDE MEDICAL PUERTO RICO LLC. Invention is credited to Doreen Borgmann, Martha Escobar, Edward E. Parsonage, Zachary J. Tegels, Robert M. Vidlund.
Application Number | 20190231333 16/380745 |
Document ID | / |
Family ID | 47666494 |
Filed Date | 2019-08-01 |
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United States Patent
Application |
20190231333 |
Kind Code |
A1 |
Tegels; Zachary J. ; et
al. |
August 1, 2019 |
BIOADHESIVE DELIVERY CATHETER MANIFOLD WITH MIXING FIXTURE AND
METHODS
Abstract
A bioadhesive delivery catheter includes a manifold, a dual
lumen tube, and a mixing member. The manifold includes a delivery
device passage and an injection port. The tube is insertable into
the delivery device passage and includes first and second lumens
positioned side-by-side. The first lumen extends proximal of the
second lumen within the delivery device passage, and the second
lumen is in flow communication with the injection port. The mixing
member is positioned between a proximal inlet of the injection port
and the second lumen and is configured to help mix a bioadhesive
material that is delivered through the injection port into the
second lumen.
Inventors: |
Tegels; Zachary J.;
(Minneapolis, MN) ; Vidlund; Robert M.; (Forest
Lake, MN) ; Borgmann; Doreen; (Hopkins, MN) ;
Parsonage; Edward E.; (St. Paul, MN) ; Escobar;
Martha; (Jordan, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ST. JUDE MEDICAL PUERTO RICO LLC |
Caguas |
PR |
US |
|
|
Assignee: |
ST. JUDE MEDICAL PUERTO RICO
LLC
Caguas
PR
|
Family ID: |
47666494 |
Appl. No.: |
16/380745 |
Filed: |
April 10, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15181272 |
Jun 13, 2016 |
10307143 |
|
|
16380745 |
|
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|
|
13744018 |
Jan 17, 2013 |
9370345 |
|
|
15181272 |
|
|
|
|
61589930 |
Jan 24, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/0057 20130101;
A61B 17/00491 20130101; Y10T 29/49826 20150115; A61B 2017/0065
20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. A bioadhesive delivery catheter apparatus comprising: a delivery
tube comprising: a first lumen in fluid communication with an
interior of a balloon and configured to deliver inflation fluid to
inflate the balloon; and a second lumen configured to deliver a
bioadhesive material to a tissue tract and a vessel puncture, the
bioadhesive material configured to at least partially solidify;
wherein the balloon is configured to be inserted through the tissue
tract, through the vessel puncture, and into a vessel lumen, the
balloon further configured to be inflated upon being positioned in
the vessel lumen to seal the vessel puncture to prevent the
bioadhesive material from entering the vessel lumen.
2. The apparatus of claim 1, wherein the balloon upon inflation
contacts an inner surface of the vessel lumen as the balloon is
inflated to create a seal between the vessel puncture and the
vessel lumen.
3. The apparatus of claim 1, wherein the delivery tube is partially
retracted once the balloon is inflated, causing the balloon to
contact an inner surface of the vessel lumen to seal the vessel
puncture.
4. The apparatus of claim 1, wherein after the bioadhesive material
is at least partially solidified, the balloon is deflated such that
the delivery tube can be withdrawn from the tissue tract.
5. The apparatus of claim 1, wherein the balloon upon inflation is
configured to prevent contents of the vessel lumen from entering
the tissue tract through the vessel puncture.
6. The apparatus of claim 1 further comprising an inner tube
disposed in the first lumen and configured to deliver a second
bioadhesive material to seal a bioadhesive plug tract left in the
solidified bioadhesive material after removing the delivery
tube.
7. The apparatus of claim 1 further comprising a sealing tip that
is releasably attached to an inner tube disposed in the first
lumen, the sealing tip being configured to lodge within a
bioadhesive plug tract left in the bioadhesive material after
removing the delivery tube.
8. The apparatus of claim 1, wherein the balloon is deflated by
applying a vacuum pressure to withdraw the inflation fluid out of
the balloon.
9. The apparatus of claim 1, wherein upon partially solidifying,
the bioadhesive material maintains its shape and position in the
tissue tract and vessel puncture.
10. The apparatus of claim 1 further comprising an indicator member
that indicates pressure conditions of the balloon.
11. A bioadhesive delivery catheter apparatus comprising: an
expandable member configured to be inserted through a tissue tract
into a vessel lumen and expanded to create a seal between the
vessel lumen and a vessel puncture; and a delivery tube configured
to deliver a bioadhesive material to be cured in the tissue tract
to seal the vessel puncture; wherein the expandable member is
configured to maintain the bioadhesive material in the tissue tract
and prevent the bioadhesive material from entering the vessel
lumen.
12. The apparatus of claim 11 further configured to deliver a
second bioadhesive material to seal a tract left in the solidified
bioadhesive material after removing the delivery tube.
13. The apparatus of claim 11, wherein the delivery tube is
partially retracted once the expandable member is expanded, causing
the expandable member to contact an inner surface of the vessel
lumen to seal the vessel puncture.
14. The apparatus of claim 11 further comprising a sealing tip that
is releasably attached to an inner tube disposed in the delivery
tube, the sealing tip being configured to lodge within a
bioadhesive plug tract left in the bioadhesive material after
removing the delivery tube.
15. A method of delivering a bioadhesive material comprising:
providing a tube comprising first and second lumens positioned
side-by-side, an end of the tube being inserted through a tissue
tract and into a vessel lumen through a vessel puncture; inflating
a balloon disposed proximate the end of the tube until the balloon
contacts an inner surface of the vessel lumen and seals the vessel
puncture; introducing bioadhesive material through the second lumen
and into the tissue tract; the seal preventing the bioadhesive
material from entering into the vessel lumen through the vessel
puncture; allowing the bioadhesive material to at least partially
cure in the tissue tract to seal the vessel puncture; and removing
the balloon from the vessel lumen through the tissue track while
preventing bioadhesive material from entering into the vessel
lumen.
16. The method of claim 15 comprising partially retracting the
balloon upon inflation to contact the inner surface of the vessel
lumen to seal the vessel puncture.
17. The method of claim 15 further comprising an inner tube
disposed in the first lumen and configured to deliver a second
bioadhesive material to seal a tract left in the solidified
bioadhesive material after removing the delivery tube.
18. The method of claim 15 further comprising detaching a sealing
tip in a tract left in the bioadhesive material after removing the
delivery tube.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/181,272, filed 13 Jun. 2016, now pending,
which is a continuation of U.S. patent application Ser. No.
13/744,018, filed 17 Jan. 2013, now issued as U.S. Pat. No.
9,370,345, which application claims the benefit of the filing date
of U.S. Provisional Application No. 61/589,930, filed 24 Jan. 2012,
and entitled BIOADHESIVE DELIVERY CATHETER MANIFOLD WITH MIXING
FIXTURE AND METHODS, the disclosures of which are incorporated, in
their entireties, by this reference.
TECHNICAL FIELD
[0002] The present disclosure relates generally to a method and
system for handling bioadhesive materials, and more particularly,
to methods and systems for storing, mixing and dispensing
bioadhesive material for use in sealing tissue punctures.
BACKGROUND
[0003] Various surgical procedures are routinely carried out
intravascularly or intraluminally. For example, in the treatment of
vascular disease, such as arteriosclerosis, it is a common practice
to access the artery and insert an instrument (e.g., a balloon or
other type of catheter) to carry out a procedure within the artery.
Such procedures usually involve the percutaneous puncture of the
artery so that an insertion sheath may be placed in the artery and
thereafter instruments (e.g., catheters) may pass through the
sheath to an operative position within the artery. Intravascular
and intraluminal procedures unavoidably present the problem of
stopping the bleeding at the percutaneous puncture after the
procedure has been completed and after the instruments (and any
insertion sheaths used therewith) have been removed. Bleeding from
puncture sites, particularly in the case of femoral arterial
punctures, is typically stopped by utilizing vascular closure
devices.
[0004] While there are a variety of prior art devices and
techniques for closing such punctures, one primary problem is
ensuring a complete seal of the puncture. One technique includes
the use of a bioadhesive material to seal the puncture. Some types
of bioadhesive materials must be activated prior to use, and should
be activated just prior to use in order to avoid premature
activation of the bioadhesive material that would affect its
performance. The handling and activation of bioadhesive materials
in the context of vascular and other tissue puncture closure
devices present a number of challenges.
SUMMARY
[0005] One aspect of the present disclosure relates to a
bioadhesive delivery catheter that includes a manifold, a dual
lumen tube, and a mixing member. The manifold includes a delivery
device passage and an injection port. The tube is insertable into
the delivery device passage and includes first and second lumens
positioned side-by-side. The first lumen extends proximal of the
second lumen within the delivery device passage, and the second
lumen is in flow communication with the injection port. The mixing
member is positioned between a proximal inlet of the injection port
and the second lumen.
[0006] A proximal end of the tube may include a taper. The tube may
have a reduced profile at a proximal end at a location proximal of
the second lumen. The mixing member may include a mixing chamber
defined within the delivery device passage adjacent to the tube.
The mixing member may include a mixing insert positioned within the
injection port. The mixing member may include at least first and
second mixing inserts positioned in a passage defined in the
manifold between the injection port and the delivery device
passage.
[0007] The manifold may include a bioadhesive passage that extends
from the injection port to the delivery device passage, and the
mixing member may be positioned in the bioadhesive passage. The
delivery device passage may include proximal and distal passage
portions, wherein the proximal passage portion has a smaller
cross-sectional shape than the distal passage portion. The
injection port may define a bioadhesive passage that intersects
with the distal passage portion.
[0008] Another aspect of the present disclosure relates to a method
of delivering a bioadhesive material that includes providing a
delivery device, a manifold, and a tube, wherein the manifold
includes a delivery device passage and an injection port, and the
tube includes first and second lumens positioned side-by-side. The
first lumen extends proximal of the second lumen, and the tube is
insertable into the delivery device passage with the second lumen
in flow communication with the injection port. The method also
includes extending the delivery device through the first lumen and
into a vessel puncture to locate the vessel puncture, and
delivering the bioadhesive material through the injection port and
the second lumen to the vessel puncture to seal closed the vessel
puncture.
[0009] The method may further include mixing the bioadhesive
material while delivering the bioadhesive material through the
manifold. The tube may include a reduced profile at a proximal end
of the tube. The manifold may include a mixing chamber positioned
proximal of a proximal opening into the second lumen, and the
method includes mixing the bioadhesive material in the mixing
chamber during delivery of the bioadhesive material into the second
lumen. The mixing member may be positioned in the injection port,
and the method includes mixing the bioadhesive material with the
mixing member during delivery of the bioadhesive material into the
second lumen.
[0010] A further aspect of the present disclosure relates to a
method of forming a bioadhesive delivery catheter. The method
includes forming a manifold having a delivery device passage and an
injection port, forming a tube having first and second lumens, the
first lumen extending further proximally than the second lumen,
inserting the tube into the delivery device passage to provide flow
communication between the second lumen and the injection port, and
positioning a sealant mixing member between an inlet to the
injection port and an opening into the second lumen.
[0011] The sealant mixing member may include a protrusion that
creates turbulence in a flow of bioadhesive material delivered into
the injection port. The sealant mixing member may include a mixing
chamber that is in fluid communication with the delivery device
passage. The delivery device passage may include proximal and
distal passage portions having different cross-sectional sizes, and
the tube may have a reduced cross-section proximal end portion
sized for insertion into the proximal passage portion. The method
may include forming a taper in a proximal end portion of the tube
that overlaps with a proximal opening into the second lumen of the
tube. The method may include bonding the tube to the manifold
within the delivery device passage.
[0012] The foregoing and other features, utilities, and advantages
of the invention will be apparent from the following detailed
description of the invention with reference to the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The accompanying drawings illustrate various embodiments of
the present disclosure and are a part of the specification. The
illustrated embodiments are merely examples of the present
disclosure and do not limit the scope of the invention.
[0014] FIG. 1A is a side view of an example vascular closure device
in accordance with the present disclosure.
[0015] FIG. 1B is a cross-sectional view of the vascular closure
device of FIG. 1A taken along cross-section indicators 1B-1B.
[0016] FIG. 1C is a cross-sectional view of the vascular closure
device of FIG. 1 taken along cross-section indicators 1C-1C.
[0017] FIG. 2 is a cross-sectional side view of a manifold and a
portion of a delivery tube of the vascular closure device of FIG.
1.
[0018] FIG. 3 is a cross-sectional side view of the manifold and
delivery tube of FIG. 2 assembled together.
[0019] FIG. 4 is a cross-sectional view of a proximal end portion
of another example delivery tube in accordance with the present
disclosure.
[0020] FIG. 5A is a cross-sectional side view of another example
manifold in accordance with the present disclosure.
[0021] FIG. 5B is a cross-sectional view of the manifold of FIG. 5A
taken along cross-section indicators 5B-5B.
[0022] FIGS. 6-9 show example steps of operating the vascular
closure device of FIG. 1 as part of a procedure to seal a vessel
puncture.
[0023] Throughout the drawings, identical reference numbers
designate similar, but not necessarily identical, elements.
DETAILED DESCRIPTION
[0024] The systems disclosed herein may be used to close or seal
percutaneous punctures made through the body tissue of a patient to
gain access to a body cavity of a patient. Access through these
percutaneous punctures allows a physician to carry out various
procedures in or through the body cavity for examination, surgery,
treatment and the like. While not meant to be limiting, the systems
are illustrated being used to seal percutaneous punctures that
provide access to blood vessels in patients for various procedures.
It will be appreciated that the systems are applicable to other
procedures requiring sealing of a puncture through body tissue into
a cavity including, for example, laparoscopic surgery and other
microscopic surgery techniques using a relatively small
incision.
[0025] As used in this specification and the appended claims, the
terms "engage" and "engagable" are used broadly to mean interlock,
mesh, or contact between two structures or devices. Likewise
"disengage" or "disengagable" means to remove or capable of being
removed from interlock, mesh, or contact. A "tube" is an elongated
device with a passageway. The passageway may be enclosed or open
(e.g., a trough). A "lumen" refers to any open space or cavity in a
bodily organ, especially in a blood vessel. The words "including"
and "having," as well as their derivatives, as used in the
specification, including the claims, have the same meaning as the
word "comprising." The terms "biomaterial" or "composition" refer
to a material intended to interface with biological systems to
preferably evaluate, treat, or seal any tissue, organ or function
of the body. Biomaterial refers to the complete material (precursor
molecules plus all additives, base or solvents and bioactive
agents, if any) at and after having reached and passed its
gel-point. Composition refers to the complete material before
having reached its gel-point. The term "gel" refers to the state of
matter between liquid and solid. As such, a gel has some of the
properties of a liquid (i.e., the shape is resilient and
deformable) and some of the properties of a solid (i.e., the shape
is discrete enough to maintain three dimensions on a two
dimensional surface).
[0026] The general structure and function of tissue closure devices
used for sealing a tissue puncture in an internal tissue wall
accessible through an incision in the skin are well known in the
art. Applications of closure devices including those implementing
principles described herein include closure of a percutaneous
puncture or incision in tissue separating two internal portions of
a living body, such as punctures or incisions in blood vessels,
ducts or lumens, gall bladders, livers, hearts, etc.
[0027] An exemplary embodiment of the present disclosure relates to
a vascular closure device configured to deliver a volume of
bioadhesive material to a vessel punctured to seal close the vessel
puncture. The vascular closure device includes a manifold and a
dual lumen tube connected to the manifold. The manifold includes a
base portion that defines a delivery device passage, and an
injection port that defines a bioadhesive passage. One lumen of the
dual lumen delivery tube is connected in flow communication with an
inlet to the delivery device passage. The other lumen of the dual
lumen delivery tube is connected in flow communication with the
bioadhesive passage of the injection port. The first lumen may
extend further proximally than the second lumen. The manifold may
further define a mixing chamber or other mixing feature that
provides at least some mixing of the bioadhesive material prior to
entering into the second lumen and being delivered to the vessel
puncture. The bioadhesive material may include a biomaterial. The
bioadhesive material may include multiple components (e.g.,
compositions) that require mixing prior to delivery to the tissue
puncture.
[0028] An opposite or distal end of the delivery tube includes a
balloon mounted thereto that is arranged in flow communication with
the first lumen. The second lumen terminates at a distal opening
that is positioned proximal of the balloon. In operation, the
balloon is positioned within the vessel and inflated to temporarily
seal closed the vessel puncture from within the vessel. The
bioadhesive material is then delivered through the second lumen to
a location outside of and adjacent to the vessel to seal closed the
vessel puncture from outside of the vessel. Thereafter, the
delivery tube is removed through the bioadhesive material that has
been deposited outside of the vessel.
[0029] The vascular closure device may include a balloon locating
device used to deliver a secondary flow of bioadhesive material
that seals closed a passage left in the first volume of bioadhesive
material upon removal of the delivery tube. The balloon locating
device may also, or alternatively, deposit a detachable sealing tip
within the first volume of bioadhesive material to seal closed a
passage in the first volume of bioadhesive material left upon
removal of the delivery tube. The balloon locating device may
provide a manifold for delivery of inflation fluid into the first
lumen and to the balloon.
[0030] One example bioadhesive delivery manifold in accordance with
the present disclosure includes a mixing member in place of or in
addition to the mixing chamber. The mixing member may be
positioned, for example, at the injection port, within the
bioadhesive passage, or within the mixing chamber. The mixing
member may be in the form of, for example, a fin, a corkscrew
member, a plurality of threads, a baffle, or other structure that
induces turbulence in or disrupts the flow path of the bioadhesive
material being delivered to the second lumen of the delivery
tube.
[0031] Referring now to FIGS. 1A-5B, an example vascular closure
device 10 is shown and described. The vascular closure device 10
includes a manifold 12, a delivery tube 14, and a balloon location
device 16. The delivery tube 14 is inserted into one end of the
manifold 12. A portion of the balloon location device 16 is
inserted into an opposite end of the manifold 12 and through one of
the lumens of the delivery tube 14. The delivery tube 14 includes
at least two separate and distinct lumens that are positioned
side-by-side. One of the lumens is used to deliver inflation fluid
to a balloon that is positioned at a distal end of the delivery
tube 14. The other lumen is used for delivery of a bioadhesive
material from the manifold 12 to a distal end of the delivery tube
14 at a location proximal of the balloon. The manifold 12 is
configured to provide at least some mixing of the bioadhesive
material prior to and during delivery of the bioadhesive material
into the delivery tube 14.
[0032] The manifold 12 includes a base 20, an injection port 22,
and a latch 23 (see FIGS. 1A and 2). The base 20 includes proximal
and distal ends 24, 26, a delivery device passage 28 and a proximal
seat 30 in communication with the delivery device passage 28, a
distal opening 32, also in flow communication with delivery device
passage 28, a mixing chamber 34, and a step 36 defined within the
delivery device passage 28. The delivery device passage 28 is sized
to receive a proximal end of the delivery tube 14. The proximal
seat 30 is sized to receive a portion of the balloon location
device 16. The step 36 is positioned at a location along a length
of the delivery device passage 28 that is distal of the proximal
seat 30 and proximal of a bioadhesive passage 38 of the injection
port 22 (see FIG. 2). The mixing chamber 34 is typically defined at
least partially within the delivery device passage 28. The mixing
chamber 34 may be arranged adjacent to the bioadhesive passage 38.
The mixing chamber 34 may include an open space or cavity within
which the bioadhesive material may mix and flow after being
expelled from the bioadhesive passage 38 and prior to entry into
the delivery tube 14.
[0033] FIG. 3 shows one configuration for the mixing chamber 34.
FIG. 5A shows another mixing chamber 134 embodiment having a
different shape and size. The mixing chamber 134 may have an
increased size as compared to mixing chamber 34, which may provide
additional space for mixing of the bioadhesive material prior to
entering the delivery tube 14.
[0034] The latch 23 may be used to connect the manifold 12 to an
insertion sheath such as the sheath 2 shown in FIGS. 6-9. The latch
23 may include at least one latch member that connects to a hub 4
of the sheath 2, thereby limiting at least some axial movement of
the manifold 12 relative to the sheath 2. In other arrangements,
the manifold 12 may be operable without the latch 23 and be able to
move independent of the sheath 2 during operation of the vascular
closure device 10.
[0035] The delivery tube 14 may be a dual lumen tube that includes
at least first and second lumens 40, 42. The delivery tube 14 may
be formed using an extrusion process. The first lumen 40 includes
proximal and distal openings 46, 48 (see FIGS. 1A and 2). The
proximal opening 46 is in flow communication with the proximal seat
30 of the manifold 12. The distal opening 48 is open to an interior
of a balloon 44 that is positioned at a proximal end of the
delivery tube 14 (see FIG. 1A).
[0036] The second lumen 42 includes proximal and distal openings
50, 52. The proximal opening 50 is in flow communication with the
mixing chamber 34. The distal opening 52 is open at a distal end
portion of the delivery tube 14 that is located proximal of the
balloon 44. Typically, the first lumen 40 is configured to deliver
an inflation fluid delivered through the balloon location device 16
and to the balloon 44. The second lumen 42 is typically configured
to deliver a flow of bioadhesive material from the injection port
22, through the bioadhesive passage 38, and through the mixing
chamber 34 and second lumen 42 to the distal opening 52. Typically,
the distal opening 52 is positioned proximal of the balloon 44 and
located outside of a vessel puncture that is to be treated as
described below with reference to FIGS. 6-9.
[0037] The first and second lumens 40, 42 are positioned
side-by-side. The first lumen 40 may have, for example, a generally
circular cross-sectional shape (see FIG. 1B). The second lumen 42
may have, for example, a generally crescent cross-sectional shape
as (see FIG. 1B). Other configurations are possible, including one
in which the first and second lumens 40, 42 each have a generally
circular cross-sectional shape. Providing at least one of the first
and second lumens 40, 42 with a crescent or oval cross-sectional
shape may help reduce an outer profile of the delivery tube 14.
Reducing the outer profile of the delivery tube 14 may help reduce
an outer profile of the manifold 12 and help limit damage to a
tissue puncture through which the delivery tube 14 is advanced for
treatment purposes.
[0038] The delivery tube 14 may be tapered at its distal end. In
one example, the delivery tube 14 is tapered from the proximal
opening 50 of the second lumen 42 towards the proximal opening 46
of the first lumen 40. FIG. 4 shows an alternative delivery tube
114 that includes a tapered surface 154. The tapered surface 154
may be formed using, for example, skiving, laser cutting, or
drilling. The tapered surface 154 may be formed along portions of
the proximal end portion of the delivery tube 14. The tapered
surface 154 may improve insertability of the delivery tube 14 into
the manifold 12 and provide an improved flow of the bioadhesive
material into the second lumen 42. The tapered surface 154 may be
maintained outside of the first lumen 40, such as vertically above
a separation plane X as shown in FIG. 1B.
[0039] The balloon location device 16 may include a housing 60, an
inner tube 62, an inner tube manifold 64, an inflation fluid
manifold 66, and an inflation lumen 67 (see FIGS. 1A and 1C). The
balloon location device 16 may provide inflation fluid to the first
lumen 40 of the delivery tube 14 through the inflation fluid
manifold 66 and inflation lumen 67 (see FIGS. 1A and 1C). The
inflation fluid may flow around the inner tube 62 within the
housing 60, manifold 12, and delivery tube 14. The inflation fluid
may flow to the balloon 44 for inflating the balloon 44 when the
balloon 44 is positioned extending through a vessel puncture and
within a vessel lumen. The balloon may be deflated by applying a
vacuum pressure to withdraw the inflation fluid out of the balloon
44 and through the inflation fluid manifold 66.
[0040] The inner tube 62 may extend through the housing 60, the
delivery device passage 28, and out of the distal opening 48 of the
first lumen 40 to a position distal of the delivery tube 14. The
inner tube 62 may have a variety of purposes, including, for
example, delivery of a secondary bioadhesive material and providing
a pathway for a suture (not shown) to the distal end of the balloon
location device 16. FIG. 9 illustrates delivery of the secondary
bioadhesive material within a deposited first bioadhesive material
after removal of the delivery tube 14 through the deposited first
bioadhesive material. More details concerning operation of the
inner tube 62 are described below with reference to FIG. 9.
[0041] The inner tube 62 may include a distal end 68 and an inner
tube lumen (see FIGS. 1A and 1C). A distal end of the balloon 44
may be secured to the inner tube 62. Inflating the balloon 44 may
move the inner tube 62 relative to the housing 60, thereby visually
showing an inflation condition of the balloon 44. More details
concerning operation of a balloon location device for purposes of,
for example, showing an inflation condition of an inflation balloon
are described with reference to U.S. Patent Application No.
61/590,000 filed on 24 Jan. 2012 and entitled "Balloon Location
Device Manifold for Vascular Closure Device and Methods," which
application is incorporated herein in its entirety by this
reference.
[0042] The inner tube manifold 64 may be configured to be attached
to a secondary bioadhesive carrier 9 as described below with
reference to FIG. 9. In other arrangements, the inner tube manifold
64 may be used to connect other devices and provide delivery of
different types of fluids to the inner tube 62.
[0043] Referring again to FIGS. 2 and 3, the delivery tube 14 may
be secured within the manifold 12 using an adhesive or other
bonding agent in a proximal passage portion 29 of the delivery
device passage 28 (see FIG. 3). The bond formed by the adhesive may
secure the delivery tube 14 to the manifold 12 and provide a seal
that limits passage of the bioadhesive material within the mixing
chamber 34 from advancing distally into the proximal seat 30.
[0044] The delivery tube 14 may be secured to a proximal passage
portion 41 of the delivery device passage 28 using, for example, an
adhesive or other bonding agent, an interference fit, or other
connection provided between the delivery tube 14 and the distal
passage portion 31. The connection between the delivery tube 14 and
distal passage portion 31 may limit passage of the bioadhesive
material from the mixing chamber 34 distally out of the distal
opening 32 in the manifold 12.
[0045] In other arrangements, the bioadhesive material, when
delivered into the delivery device passage 28, may be used to
provide, at least in part, a seal between the delivery tube 14 and
the manifold 12.
[0046] In some arrangements, the delivery tube 14 may include a
strain relief feature where the delivery tube 14 extends out of the
distal opening 32 of the manifold 12. The strain relief feature may
include, for example, a coil structure or other feature that
resists crimping or crushing of the delivery tube 14.
[0047] Referring now to FIGS. 5A and 5B, an alternative manifold
112 is shown including a base 120 and an injection port 122. The
base 120 includes a delivery device passage 128, a mixing chamber
134, and a preliminary mixing chamber 135. The injection port 122
includes a bioadhesive passage 138. The preliminary mixing chamber
135 may be positioned proximal of the bioadhesive passage 138. The
mixing chamber 134 may be positioned distal of the bioadhesive
passage 138. The mixing chamber 134 and preliminary mixing chamber
135 may be configured to provide at least some mixing of a
bioadhesive material prior to delivering the bioadhesive material
to the second lumen 42 of the delivery tube 14.
[0048] The manifold 112 may also include a set of first mixing
members 137 positioned within the preliminary mixing chamber 135.
At least one second mixing member 139 may be positioned within the
mixing chamber 134. The first and second mixing members 137, 139
may have any desired shape and size, and be arranged in any desired
configuration. FIG. 5B shows the first mixing members 137 each
having a contoured shape and being arranged in a spiral pattern.
The second mixing member 139 is shown having a generally
wedge-shaped construction. Many other shapes, sizes and
arrangements are possible for the first and second mixing members
137, 139. The first and second mixing members 137, 139 may be
arranged and configured to provide at least some agitation and
turbulence in the flow of bioadhesive material to improve mixing
and activation of the bioadhesive material prior to entry into the
second lumen 42. The first and second mixing members 137, 139 may
be mounted to the manifold 112 using a releasable connection, or
may be integrally formed as a single piece with the manifold.
[0049] In other arrangements, the bioadhesive passage 138 may be
configured with a shape or other feature that provides enhanced
mixing of the bioadhesive material. In one example, the bioadhesive
passage 138 includes a corkscrew configuration. In another
embodiment, the bioadhesive passage 138 includes a helical shaped
thread or rib.
[0050] Referring now to FIGS. 6-9, an example method of treating a
vessel puncture is shown and described. FIG. 6 illustrates a sheath
2 having a distal end 6 thereof advanced through a vessel puncture
82 of a vessel 80 and into the vessel lumen 84. The sheath 2
extends through a tissue tract 88 of a tissue layer 86 prior to
advancing through the vessel puncture 82. A distal end of the
vascular closure device 10 is inserted into the hub 4 of the sheath
2 until the latch 23 of the manifold 12 engages with the hub 4 as
shown in FIG. 7. The balloon 44 is inflated by delivering a volume
of inflation fluid from an inflation fluid source 7, through the
balloon location device 16 and manifold 12 and into the first lumen
40 of the delivery tube 14. The vascular closure device 10 and
sheath 2 are retracted together until the inflated balloon 44
contacts an inner surface of the vessel 80 to temporarily seal
closed the vessel puncture 82.
[0051] A bioadhesive material is delivered from a first bioadhesive
carrier 8, through the injection port 22 of the manifold 12, and
into the second lumen 42. The first and second bioadhesive carriers
8, 9 may include chambers 90, 91 (see FIG. 6) that each hold a
component of the first bioadhesive material. The components held in
the chambers 90, 91 may be mixed together as the first bioadhesive
material is delivered into and through the manifold 12 before
entering the second lumen 42. Mixing the components may activate
the components. The first and second bioadhesive carriers 8, 9 may
be constructed as a syringe, such as disclosed in U.S. patent
application Ser. No. 13/106,707 filed on 12 May 2011 and entitled
"Bioadhesive Applicator and Methods of Sealing Tissue Punctures
Using Same," which application is incorporated herein in its
entirety by this reference.
[0052] The bioadhesive material is expelled out through the distal
opening 52 to a location within the tissue tract 88 adjacent to the
vessel puncture 82, as shown in FIG. 8. The bioadhesive material
may form a bioadhesive plug 5. The bioadhesive material may flow to
at least partially fill the vessel puncture 82 and tissue tract 88
and a space between the vessel 80 and tissue layer 86. The
bioadhesive material may be allowed to cure for a predetermined
amount of time to at least partially solidify and maintain a shape
as the bioadhesive plug 5.
[0053] Once the bioadhesive material is at least partially cured
into the bioadhesive plug 5, the balloon 44 is deflated via the
inflation fluid source 7, and the delivery tube 14 is withdrawn
through the bioadhesive plug 5, as shown in FIG. 9. Removing the
delivery tube 14 through the bioadhesive plug 5 may leave a tract 3
through the bioadhesive plug 5. The tract 3 may be at least
partially filled or plugged by delivering a second bioadhesive
material from the second bioadhesive carrier 9, through the inner
tube 62 and out of the distal end 68 of the inner tube 62, as shown
in FIG. 9. The second bioadhesive material may form a secondary
bioadhesive plug 1 that seals closed the tract 3. Thereafter, the
entire vascular closure device 10 is removed from the vessel
puncture 82 and tissue tract 88. The bioadhesive plug 5 and the
secondary bioadhesive plug 1 seal closed the vessel puncture 82 and
tissue tract 88.
[0054] In other embodiments, a detachable sealing tip may be
carried at the distal end 68 of the inner tube 62 and detached or
disposed within the tract 3 upon removal of the vascular closure
device 10. Example detachable sealing tips are disclosed in U.S.
Patent Application No. 61/590,000, filed on 24 Jan. 2012, and
entitled "Balloon Location Device Manifold for Vascular Closure
Device and Methods," which is incorporated by reference above.
[0055] The bioadhesive materials discussed herein may comprise a
single component, or may comprise multiple sealant components that
are mixed together. The multiple sealant components may further
react together to form a crosslinked network. The sealant
components may be naturally derived or synthetic. Some example
synthetic components include polyethers such as polyethylene
glycol, polypropylene glycol and polytetrahydrofuran. Other
examples of synthetic components may include polyamine compositions
such as polyvinylpyrrolidones, polyethylene imines and hydrogenated
polyacrylonitriles. Other example sealant components include
polyacrylic and methacrylic compounds such as polyacrylic acid.
Example naturally derived components include protienaceous
compositions such as albumin, collagen and polylysine. Other
examples include carbohydrate compositions such polyhyaluronic
acid. The sealant components may also contain reactive functional
groups to promote chemical crosslinking. The sealant components may
be cross-linked by any known method including, for example,
condensation reactions, Michael addition, and free radical.
Functional groups used for cross-linking may include, for example,
thiols, acrylates, amines, succinimydyls and aldehydes, to name a
few.
[0056] The preceding description has been presented only to
illustrate and describe exemplary embodiments of the invention. It
is not intended to be exhaustive or to limit the invention to any
precise form disclosed. Many modifications and variations are
possible in light of the above teaching. It is intended that the
scope of the invention be defined by the following claims.
* * * * *