U.S. patent application number 15/709765 was filed with the patent office on 2018-01-11 for bio-absorbable wound closure device and method.
This patent application is currently assigned to Edwards Lifesciences Corporation. The applicant listed for this patent is Edwards Lifesciences Corporation. Invention is credited to David M. Taylor.
Application Number | 20180008249 15/709765 |
Document ID | / |
Family ID | 55524679 |
Filed Date | 2018-01-11 |
United States Patent
Application |
20180008249 |
Kind Code |
A1 |
Taylor; David M. |
January 11, 2018 |
BIO-ABSORBABLE WOUND CLOSURE DEVICE AND METHOD
Abstract
A wound closure device comprises a first frame and a flexible
tubular section connected to the first frame, the first frame
implantable through a wound in a patient's skin into a lumen of a
blood vessel with a portion of the tubular section extending out
through the skin. The tubular section has a first portion and a
second portion, a wall of the tubular section defining a coaxial
inner bore. Twisting the first portion relative to the second
portion of the tubular section closes the bore is closed in an area
of the tubular section between the first and second portions,
thereby closing the wound. Also disclosed is an embodiment for
closing an opening in a heart, as well as a delivery device,
systems, and methods.
Inventors: |
Taylor; David M.; (Lake
Forest, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Edwards Lifesciences Corporation |
Irvine |
CA |
US |
|
|
Assignee: |
Edwards Lifesciences
Corporation
Irvine
CA
|
Family ID: |
55524679 |
Appl. No.: |
15/709765 |
Filed: |
September 20, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14490334 |
Sep 18, 2014 |
9795366 |
|
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15709765 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00575
20130101; A61B 2017/00592 20130101; A61B 2017/00597 20130101; A61B
2017/00654 20130101; A61B 2017/00867 20130101; A61B 2017/00659
20130101; A61B 2017/00606 20130101; A61B 2017/00623 20130101; A61B
2017/00243 20130101; A61B 2017/00004 20130101; A61B 17/0057
20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. A device for closing a wound, the device comprising an implant
having a first end, a second end, and a longitudinal axis extending
between the first end and the second end, the implant comprising: a
first frame at the first end; and a flexible tubular section
connected to the first frame and extending along the longitudinal
axis, the tubular section having a first portion and a second
portion; wherein a wall of the tubular section defines a coaxial
inner bore, and wherein the device is adjustable to a first
position where the first portion and the second portion of the
tubular section are rotated circumferentially around the
longitudinal axis in a first direction relative to one another,
such that the bore is closed in an area of the tubular section
between the first and second portions.
2. The device of claim 1, wherein the device is adjustable to a
second position where the first portion and the second portion of
the tubular section are rotated circumferentially in a direction
opposite to the first direction relative to one another, such that
the bore is open between the first and second portions, and wherein
a length of the implant from the first end to the second end is
longer in the second position than in the first position.
3. The device of claim 1, wherein the tubular section comprises at
least one longitudinal strand for holding the first position.
4. The device of claim 1, wherein the tubular section comprises
nitinol.
5. The device of claim 1, wherein in the first position, a twist
seal is formed at the area of the tubular section between the first
and second portions, wherein the twist seal isolates a portion of
the bore in the first portion of the tubular section from a portion
of the bore in the second portion of the tubular section.
6. The device of claim 1, wherein the first frame is
ring-shaped.
7. The device of claim 1, wherein a width of the first frame is
from about 30 French to about 35 French.
8. The device of claim 1, wherein the first frame is radially
compressible.
9. The device of claim 1, wherein the first frame comprises an
expandable stent.
10. The device of claim 1, further comprising a plug insertable
into the tubular section of the implant.
11. The device of claim 10, wherein when the implant is in the
first position, the first frame is connected to the first portion
of the tubular section, and the plug is inserted in the second
portion of the tubular section, the area of the tubular section
between the first and second portions has a first width, the first
frame has a second width greater than the first width, and the
second portion of the tubular section is expanded radially outwards
by the inserted plug to a third width greater than the first
width.
12. The device of claim 10, wherein the plug comprises
collagen.
13. The device of claim 1, wherein the implant further comprises a
second frame connected to the tubular section at the second end of
the implant.
14. The device of claim 13, wherein the first frame and the second
frame have substantially the same width.
15. The device of claim 13, wherein in the first position, the area
of the tubular section between the first and second portions has a
first width, and the first frame and the second frame each has a
width greater than the first width.
16. The device of claim 1, wherein a material of the tubular
section is softer than a material of the frame.
17. The device of claim 1, wherein the implant comprises a
bioabsorbable material.
18. The device of claim 17, wherein the bioabsorbable material is
at least one of a bioabsorbable polymer, polyglycolide,
polylactide, poly(c-caprolactone), or
poly(lactide-co-glycolide).
19. A system for closing a wound, the system comprising the implant
of claim 1 and a delivery device, the delivery device comprising
delivery sheath and a pusher telescopically slideable into an inner
bore of the delivery sheath, the delivery sheath dimensioned to
receive the first frame of the implant and the pusher dimensioned
to receive the tubular section of the implant.
20. The system of claim 19, further comprising further comprising a
plug insertable into the tubular section of the implant.
Description
RELATED APPLICATIONS
[0001] This application claims priority to U.S. Non Provisional
application Ser. No. 14/490,334, filed Sep. 18, 2014, the entire
disclosure of which is incorporated herein by reference.
BACKGROUND
Field
[0002] The present application concerns wound closure devices and
methods of implanting the devices. The wound closure devices and
methods can be used for percutaneous occlusion of large vascular
access sites in the human body. Embodiments of the wound closure
device may be used to occlude vascular access sites that are, for
example, larger than about 14 French in diameter. The wound closure
devices and methods can also be used for occlusion of other access
sites, for example, through a wall of a heart such as an apical
access site of a heart.
Description of Related Art
[0003] Various procedures that are performed on a patient's
vascular system and/or heart are performed percutaneously and via
an arteriotomy hole or vascular access site. Upon completion of
such procedures, the arteriotomy hole or vascular access site must
be occluded or closed. Some known occlusion methods include needle
and suture methods, stapling methods, methods involving exterior
compression, methods involving solid collagen plugs, and methods
involving balloon occlusions and liquid collagen sealing. However,
these and other known wound closure or occlusion methods may only
occlude or close arteriotomy holes that are smaller than, for
example, about 14 French, and may generally only be effective in
occluding arteriotomy holes that are smaller than about 8
French.
[0004] The above methods are therefore limited to closing smaller
vascular access sites. Furthermore, the procedures are complicated,
and good occlusions or seals may still be difficult to obtain even
for smaller openings.
[0005] As a result, while procedures such as percutaneous heart
valve replacements can generally be performed minimally invasively,
depending on the size of the vascular access site needed for the
procedures, a more invasive follow-up procedure may still be
required to effectively close the access site.
[0006] In other applications, access sites may be made directly in
a wall of a heart, for example, at or near the apex of a heart. In
these such applications, current sealing devices and methods may be
similarly complex and relatively ineffective.
SUMMARY
[0007] Accordingly, there is a need to provide devices and methods
for more effectively and less invasively closing large arteriotomy
holes or vascular access sites. It is therefore an object of the
invention to provide a wound closure device and a method for
percutaneously closing large arteriotomy access sites, for example,
access sites that are larger than about 14 French in diameter, and
in some embodiments, access sites that are as large as about 24
French to about 30 French in diameter, or greater.
[0008] Another object of the invention is to provide a wound
closure device and method that can also be applied percutaneously
to an arteriotomy hole after various percutaneous procedures, such
as, for example, retrograde delivery or replacement of a prosthetic
heart valve. In some embodiments, such procedures are performed
through, for example, the femoral artery, where embodiments of the
wound closure device can be deployed to seal a large arteriotomy
hole in the femoral artery.
[0009] There is also a need to provide devices and methods for more
effectively closing access sites in heart walls, for example,
apical access sites. It is therefore another object of the
invention to provide a wound closure device and a method for more
effectively closing access sites in heart walls, and more
specifically, for closing apical access sites.
[0010] In accordance with the objects of the invention, embodiments
of the invention provide percutaneous wound closure devices and
methods for occluding large vascular access sites, for example,
arteriotomy holes that are larger than about 14 French in diameter.
Currently, while more invasive cutdown and repair methods have been
studied for occluding larger vascular access sites, no previously
known percutaneous procedures have successfully addressed this
issue. Other embodiments of the invention provide wound closure
devices and methods for occluding access sites in heart walls, for
example, apical access sites.
[0011] Embodiments of the invention therefore provide devices and
methods for a fast and safe closure of large vascular or heart
access sites.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The foregoing and other features and advantages of the
invention will become apparent from the following detailed
description of embodiments, by means of the accompanying drawings.
In the drawings:
[0013] FIG. 1 shows a wound closure device according to an
embodiment of the invention;
[0014] FIG. 2 is a cross-sectional view of an implant of a wound
closure device according to another embodiment of the
invention;
[0015] FIG. 3 is a perspective view of a delivery sheath according
to an embodiment of the invention;
[0016] FIG. 4 is a cross-sectional view of the delivery sheath of
FIG. 3;
[0017] FIG. 5 is a perspective view of a pusher tool according to
an embodiment of the invention;
[0018] FIG. 6 is a cross-sectional view of the pusher tool of FIG.
5;
[0019] FIG. 7 is a flow chart illustrating a method of implanting a
wound closure device according to an embodiment of the invention;
and
[0020] FIGS. 8-12 illustrate method steps of implanting a wound
closure device according to another embodiment of the
invention;
[0021] FIGS. 13-14 show a wound closure device according to yet
another embodiment of the invention; and
[0022] FIGS. 15-16 illustrate steps of implanting the wound closure
device of FIGS. 13-14.
DETAILED DESCRIPTION
[0023] FIG. 1 shows a wound closure device according to an
embodiment of the invention. The device includes a sealing or
occluding means, for example, an implant 1 as illustrated in FIG.
1. The device may further include a plugging or stabilization
means, for example, a plug 2 as further illustrated in FIG. 1.
[0024] The implant 1 has a longitudinal axis, a distal, first end
14 with a first opening 15 and a proximal, second end 16 with a
second opening 17, where the distal first end is configured to be
the leading end during implantation. In a resting or unstressed
position, the second opening 17 is generally smaller than the first
opening 15. The first end 14 of the implant 1 includes a frame or
ring 11, which may be circular, oval-shaped, or ring-shaped, and
may have a diameter of from about 30 French to about 35 French. In
some embodiments, the ring 11 may be larger or smaller than from
about 30 French to about 35 French, depending on the particular
application. The ring 11 may be made of or include a bioabsorbable
material, for example, any of the bioabsorbable polymers and
materials discussed below. In some embodiments, the ring comprises
a shape memory material, for example, nitinol and/or a shape memory
polymer. The ring 11 is collapsible to a smaller size for
advancement through a delivery means, such as a delivery sheath
(e.g., the delivery sheath 3 illustrated in FIG. 3).
[0025] The implant 1 further includes an elastic tube, tubular
section, or tubular portion 12 attached or affixed to the ring 11,
the tube 12 comprising a first or distal portion 18 and a second or
proximal portion 19. A wall of the tube 12 defines a bore or lumen,
which is coaxial with the longitudinal axis in some embodiments.
The tube 12 may have a resting diameter of from about 16 French to
about 18 French, and may have a wall thickness of from about 0.01
inches (about 0.25 mm) to about 0.015 inches (about 0.4 mm), and an
initial length of about 15 cm prior to implantation. The tube 12
may be arranged as a mesh, and/or may be made of a material that
has a lower durometer or is softer than the material of the ring
11, and may also be made to be thinner than the ring 11. The tube
12 may also be made of or include a bioabsorbable material, and/or
may be made of or include another soft material, for example,
urethane, silicone, ethylene-propylene rubber, EPDM,
fluoroelastomer, or the like. The tube 12 is attached or affixed to
the ring 11, for example, by molding, adhering, and/or welding or
by various other means, and the tube 12 may be stretched to fit the
ring 11 at the attachment. The seal formed between the ring 11 and
the tube 12 may prevent blood from flowing therethrough.
[0026] Each part of the implant may be made of a bioabsorbable
polymer or other bioabsorbable material, for example,
polyglycolide, polylactide, poly(c-caprolactone),
poly(lactide-co-glycolide), or of various other bioabsorbable
materials. The parts of the implant can be made of the same
materials, or can be made of different materials.
[0027] FIG. 2 is a cross-sectional view of an implant 1' of a wound
closure device according to another embodiment of the invention.
The implant 1' differs from the implant 1 of FIG. 1 in that the
ring 11' in FIG. 2 is designed as a stent, for example, a single
crown stent. The ring may alternatively be a multiple crown stent
in other embodiments. The stent ring 11' may allow for more uniform
crimping or compressing when the implant 1' is inserted into a
delivery sheath. In some embodiments, the stent may also be
configured to be flared or tapered towards one direction, to create
a contour at the first end that reduces or minimizes intrusion into
a blood vessel and/or reduces the obstruction of blood flow after
implantation of the wound closure device.
[0028] Referring back to FIG. 1, the wound closure device may
further include a plug 2. The plug 2 may be made of or include
collagen, for example, a bovine collagen. In the illustrated
embodiment, the plug 2 is substantially cylindrical in shape, and
has a tapered or beveled end 21, which may facilitate insertion of
the left side of the plug 2 into second opening 17 at the second
end on the right side of the tube 12 as illustrated. The plug may
be from about 0.5 inches (about 13 mm) to about 0.75 inches (about
20 mm) long and about 0.25 inches (about 6 mm) in diameter.
Generally, the diameter of plug 2 will be greater than the resting
diameter of the tube 12, so that advancement of the plug 2 through
the tube 12 will effect a radially outward stretching of the tube
12 to accommodate the plug 2. Meanwhile, in some embodiments, the
implant 1 may be implanted without the addition of the plug 2.
[0029] FIGS. 3 and 4 show a holding and/or delivery means, for
example, a delivery device such as a sheath 3 for implanting a
wound closure implant 1 according to an embodiment of the
invention. FIGS. 5 and 6 show a pushing or advancing means, for
example, a pusher device or tool 4 for advancing the wound closure
implant 1 through the delivery sheath 3 according to an embodiment
of the invention.
[0030] The delivery sheath 3 is a catheter device used to position
and deploy the wound closure implant 1. In the illustrated
embodiment, the delivery sheath 3 has a substantially cylindrically
shaped tubular portion 31, which may be made of or include one or
more suitable polymers, for example, polypropylene, and which has
an outer diameter of about 20 French. At a proximal end of the
tubular portion 31, the delivery sheath 3 may further include a
grip 32, which may be in some embodiments a heat shrink grip that
is fixed to the tubular portion 31. The tubular portion also
defines a coaxial inner bore 33 extending therethrough, where the
bore may have an inner diameter of about 18 French. An entire
length of the delivery sheath 3 may be approximately 30
centimeters.
[0031] Meanwhile, the pusher tool 4 is sized to be inserted into
the bore 33 of the delivery sheath 3, thereby providing a delivery
system for the implant. The pusher tool 4 also includes a
cylindrically shaped tubular portion 41, which may be made of or
include one or more suitable polymers, for example, polyether block
amide (for example, PEBAX.RTM. polyether block amide (Arkema,
Colombes, France)) and/or polyethylene, and which may have an outer
diameter slightly smaller than the inner diameter of the delivery
sheath 3. For example, the tubular portion 41 of the pusher tool 4
may have an outer diameter of about 17.5 French when the inner
diameter of the delivery sheath 3 is about 18 French. At a proximal
end of the tubular portion 41, the pusher tool 4 may further
include a compression cap 42, which may be attached to the tubular
portion 41 via, for example, a polycarbonate Luer fitting or
connector. The pusher tool 4 is generally longer in length than the
delivery sheath 3, and in the instant embodiment, is approximately
40 centimeters. In addition, the tubular portion 41 of the pusher
tool 4 defines a coaxial inner bore 43 which extends therethrough.
The inner diameter of the tubular portion 41 in the instant
embodiment is about 12.5 French, but in general, should be sized to
readily accommodate the elastic tube 12 of the implant 1 when the
tube 12 is compressed or collapsed radially, as well as a guide
wire (not shown) passing through the implant 1. The tubular portion
41 of the pusher tool 4 may also include an additional longitudinal
slit 44, which extends from a distal end towards the proximal end
of the pusher tool 4 over, for example, about 15 centimeters of the
tubular portion 41. In some embodiments, the length of the slit 44
corresponds substantially to the length of the tube 12 of the
implant 1, and may facilitate easier loading or insertion of the
elastic tube 12 of the implant 1 into the pusher tool 4.
[0032] FIG. 7 illustrates a block diagram flow chart illustrating a
method of implanting a wound closure device to close a wound
opening at a vascular access site according to one embodiment of
the invention. In some embodiments, the wound opening has a width
greater than about 14 French. FIGS. 8-12 illustrate various steps
in a method of implanting a wound closure device according to
another embodiment of the invention.
[0033] After carrying out a procedure in which a wound opening, for
example, an arteriotomy hole or vascular access site is formed in a
blood vessel, such as for a percutaneous delivery of a prosthetic
heart valve, the tools utilized for the initial procedure are first
removed from the vascular access site. In some embodiments, a guide
wire may remain from the initial procedure and may be utilized for
the delivery of the wound closure device, or a different or
additional guide wire may be inserted prior to delivery of the
wound closure device.
[0034] In step S101 of FIG. 7, a delivery sheath is inserted at the
vascular access site. The delivery sheath may be deployed along a
guide wire previously inserted or left behind from an initial
procedure or along a new guide wire. At least a distal tip of the
delivery sheath is inserted through the arteriotomy hole in the
wall of the blood vessel, and into the blood vessel. In step S102,
the implant of the wound closure device (e.g., implant 1 as seen in
FIG. 1) is attached to the pusher tool 4. Referring back to FIGS.
1-6, attachment of the implant 1 to the pusher tool 4 may include
collapsing or compressing the tubular portion 12 of the implant 1
(e.g., manually by pinching or other means) and inserting the
tubular portion 12 into the bore 43 of the pusher tool 4. In
embodiments where the pusher tool 4 has a slit 44, the tubular
portion 12 of the implant 1 can be inserted into the bore 43
through the slit 44, for example, by manually expanding the slit
44. Generally, the implant 1 will be attached to the pusher tool 4,
such that the ring 11 of the implant 1 remains on an outside of the
pusher tool 4 and rests against or is adjacent to the distal end of
the pusher tool 4. Generally, ring 11 of implant 1, even when
collapsed, is oversized relative to pusher tool 4, so that it will
not fit into the bore 43. In embodiments in which a guide wire is
used, the guide wire will pass through centers of both the implant
1 and the pusher tool 4. In step S103, the implant 1 and the pusher
tool 4 are inserted at a proximal end of the delivery sheath 3 into
the bore 33 of the delivery sheath 3. Here, the ring 11 of the
implant 1 is compressed to fit into the bore 33 of the delivery
sheath 3. The pusher tool 4 is then advanced through the bore 33 of
the delivery sheath 3 to advance or push the implant 1 towards the
distal opening of the delivery sheath 3.
[0035] In some embodiments of deployment methods, as discussed
above, the delivery sheath 3 may already be positioned at the
vascular access site first, prior to attachment of the implant 1 to
the pusher tool 4 and insertion of the implant 1 and the pusher
tool 4 into the delivery sheath 3, so that the implant 1 and pusher
tool 4 are inserted into the delivery sheath 3 while the delivery
sheath 3 is already positioned in a patient's body. In other
embodiments, the implant 1, pusher tool 4, and delivery sheath 3
may first be preassembled together, prior to inserting the delivery
sheath 3 at the vascular access site. FIG. 8 illustrates an
embodiment in which the delivery sheath 3, the pusher tool 4, and
the implant 1 are advanced together to a vascular access site. In
FIG. 8, the delivery sheath 3 with the pusher tool 4 and implant 1
are advanced through a tissue tract 111 of the tissue 110 of body
100 to blood vessel 120. A distal tip of delivery sheath 3 is
advanced through an opening 122 in the vessel wall 121 and into the
lumen of blood vessel 120. The advancement of the implant 1 and
delivery tools 3, 4 may be along a guide wire in some embodiments,
as previously discussed.
[0036] Then, in step S104, the pusher tool 4 is advanced further
into the delivery sheath 3 via, for example, pressure applied at
compression cap 42. The pusher tool 4 is advanced until the ring 11
of the implant 1 is moved past and out of the opening at the distal
end of the delivery sheath 3 and into the lumen of the blood vessel
120 on a distal side of the vessel wall. After the ring 11 of the
implant 1 is no longer radially compressed by the inner wall of the
delivery sheath 3, the ring 11 is allowed to expand in the lumen of
the blood vessel 120. The relative size of the ring 11 of the
implant 1 in its expanded state is generally selected to be larger
than the greatest diameter or width of the arteriotomy hole that is
to be sealed. The ring 11 of the implant 1 may be configured to
expand itself upon exiting the delivery sheath 3, or may be
configured to expand upon actuation by a practitioner or other
user. Expansion of the ring 11 of the implant 1 can be seen, for
example, in FIG. 9.
[0037] After the ring 11 of the implant 1 exits the delivery sheath
3 into the lumen of the blood vessel 120 and is allowed to expand,
in step S105, the delivery sheath 3 and the pusher tool 4 are
removed from the vascular access site. The implant 1 remains at the
vascular access site after removal of the delivery tools 3, 4 in an
open or second position in which the bore of the tubular portion 12
is open from the first portion 18 to the second portion 19 thereof.
The ring 11 of the implant 1 in its expanded state may be pushed or
pulled against an inner surface of the vessel wall 121 of the blood
vessel 120, and is prevented from escaping through the opening 122
by virtue of the oversize of the ring 11 relative to the opening
122. Therefore, when the pusher tool 4 is pulled away from the
vascular access site, the ring 11 holds the implant 1 in position
at the vascular access site and prevents the implant 1 from also
being removed from the tissue tract 111, and the portion of the
tube 12 of the implant 1 that was held in the bore 43 of the pusher
tool 4 is drawn out of the pusher tool 4. Furthermore, after
removal of the delivery tools 3, 4, the ring 11 of the implant 1
may be held against the wall 121 of the blood vessel 120 from the
luminal side by the pressure inside the blood vessel 120, which
will naturally push the ring against the wall 121 of the blood
vessel 120. In some embodiments, additional frictional or holding
means, such as frictional elements, may be located on the ring 11
or tube 12 to hold the ring 11 and/or the distal end of the tube 12
in this position. In addition, a length of the tubular portion 12
of the implant is generally selected, such that the tubular portion
12 is long enough to extend entirely through the tissue tract 111
adjacent to the vascular access site and to an outside of the body
100, for easier access by a practitioner or other user.
[0038] As seen in step S106 and as illustrated in FIG. 10, after
removal of the delivery tools 3, 4 from the vascular access site,
the tubular portion 12 of the implant 1 may be pulled from the
second end 16 on the proximal side of the vessel wall 121 to
further tension the ring 11 of the implant 1 against the wall 121
of the blood vessel 120. The second portion 19 of the tubular
portion 12 of the implant 1 is then twisted or rotated
circumferentially around the longitudinal axis of the implant 1
relative to the first portion 18 to create a twist seal 13 in the
tubular portion 12 of the implant 1 between the first portion 18
and the second portion 19 of the tubular portion 12, resulting in a
closed or first position of the implant 1. In the illustrated
embodiment, the twist seal 13 is adjacent or near the ring 11 and
the blood vessel wall 121. The twist seal 13 closes the bore or
lumen of the implant 1 and seals the opening 122. Converting the
implant from the second position to the first position by twisting
the tubular portion 12 also reduces a length of the implant 1 in
the illustrated embodiment.
[0039] The twist seal 13 may further form a substantially flat disc
or surface in the implant 1 at or near the ring 11, which blocks
the opening 122 in the vessel wall 121 and prevents or restricts
blood from flowing out of the opening 122, where the ring 11 forms
a perimeter of the disc and the tubular portion 12 converges at the
twist seal near a center of the disc. By twisting the tubular
portion 12 and forming a disc or substantially flat surface at the
ring 11, the implant 1 may reduce or prevent clots from otherwise
forming in a portion of the implant 1 recessed from the ring
11.
[0040] In some embodiments, the tubular portion of the implant may
further include one or more longitudinal stiffener strands to
facilitate the twisting, or to aid in holding the implant in the
twisted state (first position) after the twisting step. In some
embodiments, such stiffener strands or other parts of the tubular
portion may be made of or include, for example, a superelastic
nickel-titanium alloy (nitinol) or other shape memory material,
where the twisted configuration of the tubular portion represents
its unstressed state at, for example, body temperature. In such
embodiments, the implant may be cooled or held open or untwisted
during implantation, and then allowed to return to its unstressed,
twisted, state after the distal end has been placed in a desired
position.
[0041] Some embodiments of the implant may also include additional
frictional elements on its surface, for example, along part or all
of the tubular portion. These frictional elements could be used to
hold the implant in its twisted configuration and prevent, for
example, untwisting of the implant after twisting. Such frictional
elements may allow for easy rotation of the tubular portion in one
direction, for example, in a clockwise direction, to effect the
twisting seal, but the frictional elements may engage the
surrounding tissue to prevent or otherwise hinder movement of the
tubular portion in the opposite direction, for example, in a
counterclockwise direction. This may assist in locking the implant
in its final twisted configuration and prevent the implant from
inadvertently untwisting and opening back up after
implantation.
[0042] Then, in embodiments in which a plug 2 is utilized, as
illustrated in FIGS. 11 and 12, the plug 2 is advanced into and
through the second portion 19 of the tubular portion 12 of the
implant 1 towards the twist seal 13, until further advancement is
hindered or prevented by the twist seal 13 (e.g., manually or using
a pusher device). In embodiments where the plug is made of or
includes collagen, the plug 2 may expand upon contact with blood or
other bodily fluids, or with user applied fluid (for example,
saline) once inserted into the tissue tract 111. Meanwhile, the
twist seal 13 prevents the plug 2 from being inadvertently pushed
into the blood vessel 120. Generally, advancement of the plug 2 may
also serve to shorten the device, and more specifically, to shorten
a space between the ring 11 and the plug 2, which each has a larger
diameter or width compared to the twist seal 13. The shortening of
the space between the ring 11 and plug 2 serves to provide a
compressive force on the blood vessel wall 121 and/or the
surrounding tissue 110, in order to further aid in sealing and/or
healing of the access site. As illustrated in FIG. 12, the wall 121
of the blood vessel 120 around the opening 122 is pinched or
sandwiched between the ring 11 of the implant 1 and the plug 2,
where the plug 2 provides a tensile force to help securely hold the
ring 11 of the implant 1 against the inner surface of wall 121 of
the blood vessel 120, and also may contribute to the seal by
applying the compressive pressure against an outer surface of wall
121 of the blood vessel 120 and/or the surrounding tissue 110.
Here, the plug 2 is positioned in the tissue tract 111 and may
further be held in place, for example, by radially inward pressure
applied by the tissue 110 against the tubular portion 12 of the
implant and the plug 2. In the final configuration of this
embodiment, the plug 2 serves to seal the tissue tract 111, and may
further aid in sealing any leaks, such as micro leaks, from the
blood vessel 120 that leak past or around the ring 11 or through
the tubular section 12 of the implant 1. After the plug 2 is moved
to a desired final position, in some embodiments, the tubular
section 12 may be cut or otherwise shortened, so that the proximal
end of the tubular section 12 no longer extends outside of the
body.
[0043] Another embodiment of the wound closure device is
illustrated in FIGS. 13-16. The device illustrated in FIGS. 13-16
does not include a plug, but instead includes a single implant 21
with two ends 22 and a central portion. In some embodiments, the
ends 22 are identical, and may be or include rings or frames
similar to the ring 11 described in the embodiment above. In other
embodiments, the end rings may be rigid rings that are not radially
collapsible. In yet other embodiments, the ends may be configured
differently, for example, where a first ring may be radially
collapsible to facilitate easier insertion into a wound access
site, while a second ring is configured to be more rigid.
[0044] The central portion of the implant 21 may include relatively
stiff strands 23 for maintaining a desired shape or structure of
the implant 21. In some embodiments, the strands 23 may be made of
or include, for example, nitinol, or another shape memory alloy or
other material, where a twisted configuration forming a central
twist seal (e.g., as illustrated in FIG. 14) represents an
unstressed state of the implant 21 at, for example, body
temperature. In these embodiments, the implant 21 may be cooled or
held open or untwisted by an outside force during implantation, and
then allowed to return to its unstressed, twisted orientation,
after implantation. In other embodiments, the strands 23 may not
include a shape memory material, but rather may include a stiffer
material that can be bent or otherwise deformed to better hold the
implant 21 in a twisted configuration shown in FIG. 14 after
implantation and manual twisting, for example, by a practitioner or
implantation device.
[0045] In some embodiments, the implant 21 may further include a
tubular section comprising a mesh or other relatively softer
material similar to the mesh described above in the first
embodiment. In some embodiments, the mesh or other material may
surround the entire implant 21, or may only cover, for example, the
strands 23. In other embodiments, the mesh may or other material
instead be attached to the ends 22 and/or the strands 23 to cover
or seal the recesses or gaps located between the ends 22 and the
strands 23.
[0046] As indicated above, parts of the implant 21 may be made of
or include nitinol or other shape memory alloy, or another
material. Alternatively, some parts of the implant 21 may be made
of or include other biocompatible metal, alloy, or other suitable
material. Meanwhile, other portions of the implant 21, for example,
a mesh of the implant 21 and/or rings positioned at the ends 22 of
the implant 21, may be made of or include a bioabsorbable polymer
or other bioabsorbable material, similar to the materials discussed
above with respect to the first embodiment.
[0047] Referring now to FIGS. 15 and 16, the implant 21 according
to this embodiment can be implanted, for example, at an apical
access site 52 located in a heart wall 51 at or near an apex of a
heart 50. After a procedure in which apical access into a heart is
required, the implant 21 can be used to seal or close the access
site 52 at the apex of the heart.
[0048] First, in FIG. 15, the implant 21 is positioned in the
access site 52, where a distal first end 22 of the implant is
inserted through the access site 52 to an inside of the heart 50.
In some embodiments, a ring on the distal end 22 of the implant may
be radially collapsible to facilitate insertion of the implant 21
through the access site 52, where the ring can then be expanded to
its original size after passing through the access site 52. In
embodiments in which the implant 21 is twisted in its unstressed
state, the implant 21 may first be cooled, manually untwisted, or
otherwise manipulated, so that it is in its untwisted state (as
seen, e.g., in FIG. 13), during insertion.
[0049] Then, in FIG. 16, the implant is twisted to its final
configuration in the access site 52. Here, the twisting of the
implant 21 creates an effective twist seal. For example, in
embodiments in which a shape memory material is used, the strength
of the twist seal can be established and tested prior to
implantation. As seen with the first embodiment, the twisting of
the implant 21 also creates a flatter surface at the ends 22, such
that space where unwanted clots could potentially form can be
reduced or minimized. Finally, as can be seen in FIG. 16, the
twisting of the implant 21 also shortens the implants and draws the
two ends 22 closer to one another and reduces a space between the
two ends 22. This may create a compressive or pinching force on the
heart wall 51, which may further aid in healing of the tissue
around the access site 52 and anchoring of the implant 21.
[0050] Furthermore, similarly as discussed with the first
embodiment, the implant 21 in FIGS. 13-16 may also include
frictional elements on some or all of its exterior surface, which
allows for easy or preferential rotation of the implant 21 to its
final twisted configuration, shown in FIGS. 14 and 16, while
preventing or making more difficult rotation of the implant 21 back
to its open configuration shown in FIGS. 13 and 15.
[0051] Some embodiments of the wound closure device described above
may also be used interchangeably between different types of wounds.
For example, the wound closure device described in FIGS. 1-6 may be
used for an access site in a heart wall, where the plug can serve
as an enlarged proximal end of the implant. In such application,
the plug may be inserted at least past an outer surface of the
heart wall. Similarly, the wound closure device described in FIGS.
13-14 may be used for vascular access sites in some
applications.
[0052] Various other modifications of the embodiments described are
also conceivable. For example, for the implants, the shape or
configuration of the frame or ring at the distal end can be
modified in various ways for better sealing of the specific
application, such as for arteriotomy holes or for an apical access
site in a heart wall. In other embodiments, barbs or anchors or
other features can be molded into the frame or ring to facilitate a
more secure attachment to the inner wall of the blood vessel or the
heart wall. In some embodiments utilizing a plug, the tubular
portion can be modified, for example, with an outer rail design, to
allow for the plug or other plugging or stabilization means to ride
over or around the tube, rather than be inserted through the tube.
Various other modifications may also be implemented.
[0053] Embodiments of the invention provide a wound closure device
and a method for closing access sites such as large arteriotomy
holes or access sites made in a heart wall in a less invasive and
more effective manner. More specifically, some embodiments of the
invention provide a percutaneous solution for closing puncture
sites in, for example, walls of blood vessels, that are up to or
greater than about 30 French in diameter, while other embodiments
of the invention provide a solution for safely and effectively
closing an apical access site in a heart wall. The device and
method can further be applied efficiently, and in some instances,
can be effectively applied in a matter of seconds. The elasticity
of the device helps the device conform to the vessel wall, the
heart wall, and/or the tissue tract in an effective manner upon
implantation. In addition, the device and method according to
embodiments of the invention provide for an atraumatic solution for
closing a wound that does not require suturing or stapling, and
also does not require further dilation of the puncture site to
achieve hemostasis. In addition, if hemostasis is not initially
achieved with the implant, in embodiments where a guide wire is
utilized, the blood vessel or access site on the heart can still be
easily re-accessed for reapplication of the implant. Furthermore,
in embodiments where the entire implant is made of bioabsorbable
materials, there would be no sutures, staples, or other parts of
the implant left behind over time, since the entire implant would
be dissolved by the body, and the healed vessel or wall would be
available for re-access at the access site if needed.
[0054] While the present disclosure has been described in
connection with certain exemplary embodiments, it is to be
understood that the disclosure is not limited to the particular
embodiments and examples, but is instead intended to cover various
modifications and equivalent arrangements included within the
spirit and scope of the appended claims, and equivalents
thereof.
* * * * *