U.S. patent application number 11/930111 was filed with the patent office on 2008-05-08 for arteriotomy closure devices and techniques.
Invention is credited to William D. Hare, Russell A. Houser.
Application Number | 20080109030 11/930111 |
Document ID | / |
Family ID | 46329694 |
Filed Date | 2008-05-08 |
United States Patent
Application |
20080109030 |
Kind Code |
A1 |
Houser; Russell A. ; et
al. |
May 8, 2008 |
ARTERIOTOMY CLOSURE DEVICES AND TECHNIQUES
Abstract
A vascular closure system includes a swellable/bioabsorbable
tubular sealing element and a tubular advancement/deployment tool.
The sealing element and advancement tool is configured to be
attached to the outside of a tubular medical device (such as a
vascular introducer, catheter, cannula, trocar, electrode wire,
etc.) with the sealing element being advanced distally to a desired
area within the body (near or at least partially within an
arteriotomy, for example) by the advancement/deployment tool. Once
in contact with blood (or other fluid) the sealing element swells,
sealing the passageway. The system may include one of several
different means to prevent insertion (or over insertion) into the
vessel. Additional versions of the system described herein can be
used for cardiovascular applications where hemostasis (temporary or
permanent) is desired. Additionally, the system can be used with
simple modifications for any vessel, area on, in or near any
vessel, tissue area, tubular structure, duct, organ, hollow body
cavity, chamber, tissue wall, or any other structures or tissues,
where temporary or permanent sealing, plugging, reduction of an
open space, or reinforcement is needed, or alternatively, where an
open conduit or conduit reinforcement is desired. The system could
also be used as a reversible sterilization method for women by
occluding the fallopian tubes.
Inventors: |
Houser; Russell A.;
(Livermore, CA) ; Hare; William D.; (Princeton,
NJ) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
46329694 |
Appl. No.: |
11/930111 |
Filed: |
October 31, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11279242 |
Apr 10, 2006 |
|
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|
11930111 |
Oct 31, 2007 |
|
|
|
10224659 |
Aug 21, 2002 |
7025776 |
|
|
11279242 |
Apr 10, 2006 |
|
|
|
10127714 |
Apr 23, 2002 |
|
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|
10224659 |
Aug 21, 2002 |
|
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|
60286269 |
Apr 24, 2001 |
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60300892 |
Jun 25, 2001 |
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60302255 |
Jun 28, 2001 |
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Current U.S.
Class: |
606/195 ;
606/191; 606/194 |
Current CPC
Class: |
A61B 17/0057 20130101;
A61B 2017/00867 20130101; A61B 2017/00659 20130101; A61B 2017/2925
20130101; A61B 2017/00637 20130101; A61B 2017/00862 20130101; A61B
17/00491 20130101 |
Class at
Publication: |
606/195 ;
606/191; 606/194 |
International
Class: |
A61M 29/04 20060101
A61M029/04 |
Claims
1.-23. (canceled)
24. A vessel closure device comprising a first end, a second end,
and an outer wall and a lumen passing between the first end and the
second end, wherein the vessel closure device comprises a material
being one or more of a swellable, a bioabsorbable, or a
biodegradable material.
25. The vessel closure device of claim 24, wherein the material
comprises a polymer.
26. The vessel closure device of claim 25, wherein the polymer
comprises a polyethylene polymer.
27. The vessel closure device of claim 24, wherein the material
swells or expands when exposed to a fluid.
28. The vessel closure device of claim 27, wherein the fluid
comprises blood.
29. The vessel closure device of claim 24, wherein the lumen is
configured to be open during delivery and for at least a portion of
the lumen to close after delivery.
30. The vessel closure device of claim 24, wherein the vessel
closure device includes a tissue engagement area configured to
contact tissue.
31. The vessel closure device of claim 30, wherein the tissue
engagement area comprises an adhesive material.
32. The vessel closure device of claim 31, wherein the adhesive
material is configured to adhere to the tissue after blood contacts
the adhesive material.
33. The vessel closure device of claim 30, wherein the adhesive
includes a radiopaque material.
34. The vessel closure device of claim 30, wherein the tissue
engagement area extends outwardly from the outer wall.
35. The vessel closure device of claim 24, wherein the outer wall
has a first outer diameter at the first end and a second outer
diameter at the second end, the second outer diameter being less
than the first outer diameter.
36. The vessel closure device of claim 24, wherein the vessel
closure device is removable.
37. The vessel closure device of claim 24, wherein the tubular
medical device comprises one or more of a vascular introducer,
catheter, guidewire, trocar, cannula, or electrode wire.
38. The vessel closure device of claim 36, wherein the vessel
closure device includes one or more of an adhesive and a
therapeutic agent configured to affect healing at the site of
implantation of the closure device.
39. The vessel closure device of claim 24, wherein the vessel
closure device comprises a radiopaque material.
40. A method of closing an opening in a blood vessel, the method
comprising: providing a vessel closure device, the vessel closure
device comprising a first end, a second end, and a lumen passing
between the first end and the second end, wherein the vessel
closure device comprises a material being one or more of a
swellable, a bioabsorbable, or a biodegradable material;
introducing a tubular medical device into an opening in a vessel;
advancing the vessel closure device over the tubular medical device
until the vessel closure device is near or contacts the vessel,
wherein the tubular medical device passes within the lumen of the
vessel closure device; and removing the tubular medical device from
the vessel closure device, whereby the vessel closure device seals
the opening in the vessel.
41. The method of claim 40, wherein the material comprises a
polymer.
42. The method of claim 41, wherein the polymer comprises a
polyethylene polymer.
43. The method of claim 40, wherein the material swells or expands
when exposed to a fluid.
44. The method of claim 43, wherein the fluid comprises blood.
45. The method of claim 40, further comprising providing a
deployment tool to advance the vessel closure device over the
tubular medical device.
46. The method of claim 45, further comprising using the deployment
tool to advance the vessel closure device over the tubular medical
device to the vessel.
47. The method of claim 40, wherein the tubular medical device
comprises one or more of a vascular introducer, catheter,
guidewire, trocar, cannula, or electrode wire.
48. The method of claim 40, wherein the vessel closure device
includes one or more of an adhesive and a therapeutic agent
configured to affect healing at the site of implantation of the
closure device.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of and claims the benefit
of priority under Title 35, United States Code, .sctn.120 from U.S.
Pat. No. 7,025,776 having Ser. No. 10/224,659 and titled
Arteriotomy Closure Devices and Techniques and issuing on Apr. 11,
2006, which claims the benefit of U.S. patent application Ser. No.
10/127,714, filed Apr. 23, 2002 and titled Arteriotomy Closure
Devices and Techniques, which claims the benefit of priority from
U.S. Provisional Patent Application No. 60/286,269, filed Apr. 24,
2001 and titled Percutaneous Vessel Access Closure Device and
Method; from U.S. Provisional Patent Application No. 60/300,892,
filed Jun. 25, 2001 and titled Percutaneous Vessel Access Closure
Device and Method, and from U.S. Provisional Patent Application No.
60/302,255, filed Jun. 28, 2001 and titled Percutaneous Vessel
Access Closure Device and Method (Hemostatic Patch or Collar), each
of which is incorporated herein in their entirety by reference.
TECHNICAL FIELD
[0002] The field of the inventions generally relates to
cardiovascular and arterial closure devices, and, more
particularly, to arterial closure devices and techniques.
BACKGROUND
[0003] In most cardiology and radiology procedures, a catheter is
inserted into an artery, such as the femoral artery, through a
vascular introducer. When the procedure is complete, the physician
removes the catheter from the introducer and then removes the
introducer from the arteriotomy into the vessel. The physician then
must prevent or limit the amount of blood that leaks through the
arteriotomy so that the patient can be discharged. Physicians
currently use a number of methods to close the arteriotomy, such as
localized compression, sutures, collagen plugs, and adhesives,
gels, foams, and similar materials. To use localized compression,
the physician presses down against the vessel to allow the
arteriotomy to naturally clot. This method, however, can take half
an hour or more, and requires the patient to remain immobilized for
at least that period of time and be kept in the hospital for
observation. There are potentials for clots at puncture site to be
dislodged. Moreover, the amount of time necessary for the
compression can be significantly increased depending upon how much
heparin, glycoprotein IIb/IIA antagonists, or other anti-clotting
agents were used during the procedure. Sutures and collagen plugs
may have procedure variability, may require time to close the
vessel, may have negative cost factors, and may necessitate a
separate deployment device. Adhesives, gels, and foams may have
negative cost factors, may necessitate a possibly complicated
deployment process, and may have procedure variability.
SUMMARY
[0004] In one general aspect, an arterial closure device is
deliverable over a tube for placement within and against an
arteriotomy. The arterial closure device includes a first member
forming an enlargement around the circumference of the arterial
closure device and being configured to be received against an outer
surface of a vessel; a connecting member having a smaller outer
diameter than the first member, extending from the first member,
and being configured to be positioned within an arteriotomy of a
vessel; and a longitudinal channel configured to receive a tube and
passing between the first member and the connecting member.
[0005] Embodiments of the arterial closure device may include one
or more of the following features. For example, the connecting
member may include slits. The connecting member may be expandable
from a first narrow diameter to a second expanded diameter.
[0006] The arterial closure device may further include a second
member extending from the connecting member, forming an enlargement
around the circumference of the arterial closure device and being
configured to be received against an inner surface of the vessel
when the first member is received against the outer surface of the
vessel. The arterial closure device may still further include an
adhesive layer on at least one of the first member, the second
member, and the connecting member. The first member may extend at
an angle from the arterial closure device, the second member may
extend at an angle from the arterial closure device, and the first
member may be generally oriented in the direction of the second
member.
[0007] The first member may include at least one superelastic/shape
memory element configured to move between a first extended position
and a second extended position and the second member may include at
least one superelastic/shape memory element configured to move
between a first extended position and a second extended
position.
[0008] The arterial closure device may further include an adhesive
layer on at least one of the first member and the connecting
member. The arterial closure device may further include an adhesive
within the longitudinal channel. The arterial closure device may
further include longitudinal slots along the longitudinal
channel.
[0009] The arterial closure device may further include an extending
member extending from the first member in a generally opposite
direction away from the connecting member and the longitudinal
channel continues from the first member through the extending
member. The extending member may include a closable opening of the
longitudinal channel. The arterial closure device may further
include a slot along at least a part of the length of the arterial
closure device.
[0010] The arterial closure device may further include a deployment
tool, the deployment tool including a handle, a contacting section,
and an extension that extends between the handle and the contacting
section. The contacting section is configured to mate with the
arterial closure device to advance the arterial closure device over
the tube and deploy the arterial closure device within the
vessel.
[0011] In another general aspect, an arterial closure system
includes an arterial closure device and a deployment tool. The
arterial closure device includes a first member forming an
enlargement around the circumference of the arterial closure device
and being configured to be received against an outer surface of a
vessel, a connecting member having a smaller outer diameter than
the first member, extending from the first member, and being
configured to be positioned within an arteriotomy of a vessel, and
a longitudinal channel configured to receive a tube and passing
between the first member and the connecting member. The deployment
tool includes a handle, a contacting section, and an extension that
extends between the handle and the contacting section, the
contacting section being configured to mate with the arterial
closure device to advance the arterial closure device over the tube
and deploy the arterial closure device within the vessel.
[0012] Embodiments of the arterial closure system may include any
of the features described above or herein. For example, the
arterial closure system may further include a second member
extending from the connecting member, forming an enlargement around
the circumference of the arterial closure device and being
configured to be received against an inner surface of the vessel
when the first member is received against the outer surface of the
vessel. The first member may include at least one
superelastic/shape memory element configured to move between a
first extended position and a second extended position; and the
second member may include at least one superelastic/shape memory
element configured to move between a first extended position and a
second extended position.
[0013] The arterial closure device may include a slot along at
least a portion of the length of the arterial closure device and
the contacting section of the deployment tool may include a
longitudinal slot.
[0014] In another general aspect, a method of closing an opening in
a vessel includes providing an arterial closure device that
includes a first member forming an enlargement around the
circumference of the arterial closure device and being configured
to be received against an outer surface of a vessel, a connecting
member having a smaller outer diameter than the first member,
extending from the first member, and being configured to be
positioned within an arteriotomy of a vessel, and a longitudinal
channel configured to receive a tube and passing between the first
member and the connecting member. The method further includes
providing a deployment tool comprising a handle, a contacting
section, and an extension that extends between the handle and the
contacting section, the contacting section being configured to mate
with the arterial closure device to advance the arterial closure
device over the tube and deploy the arterial closure device within
the vessel. The method still further includes slidably mounting the
arterial closure device to a tube; inserting the tube through an
opening into the vessel; using the deployment tool to advance and
deploy the arterial closure device by advancing the arterial
closure device along the tube until the connecting member is
deployed within the vessel and the first member is received against
the outer surface of the vessel; and removing the tube from the
vessel and from the arterial closure device.
[0015] Embodiments of the method of closing an opening in a vessel
may include any of the features described above or herein. For
example the arterial closure device may further include a second
member extending from the connecting member, forming an enlargement
around the circumference of the arterial closure device and being
configured to be received against an inner surface of the vessel
when the first member is received against the outer surface of the
vessel and an adhesive layer is positioned on at least one of the
first member, the second member, and the connecting member, and
deploying the arterial closure device further comprises positioning
the second member against the inner surface of the vessel.
[0016] The arterial closure device, the arterial closure system,
and the arterial closure method provides considerable advantages,
as described herein. For example, the ACDs and methods described
herein can provide: (1) the ability to deploy an ACD without the
removal and re-insertion of a second device; (2) the ability to be
used on most commercial vascular introducers, catheters, tubes,
etc.; (3) the ability to use tactile feedback to correctly and
properly deploy an ACD without direct or indirect visual
assistance; (4) the ability to use adhesives to secure the device
to the vessel; (5) the ability to use adhesives to close off the
device to prevent blood leaking or seepage; and (6) the ability to
provide eluting therapeutic agents incorporated within or on the
device. Moreover, the device, system and method are advantageously
simple to use, inexpensive, and effective as a percutaneous vessel
access closure device and method.
DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a side view of a arterial closure device
positioned around a tubular section of a vascular introducer.
[0018] FIG. 2 is a side view of the arterial closure device of FIG.
1 advanced through a percutaneous opening by a deployment
instrument.
[0019] FIG. 3 is a side view of the arterial closure device of FIG.
1 deployed through a vessel wall.
[0020] FIG. 4 is a cross-sectional side view of the arterial
closure device of FIG. 1 deployed through a vessel wall.
[0021] FIG. 5 is a top view of the arterial closure device of FIG.
1.
[0022] FIGS. 6 and 7 are side and cross-sectional side views,
respectively, of a second implementation of a arterial closure
device deployed within an arteriotomy of a vessel wall.
[0023] FIG. 8 is a bottom end view of the arterial closure device
of FIG. 6 showing the flared end opened.
[0024] FIG. 9 is a bottom end view of the arterial closure device
of FIG. 6 showing the flared end closed.
[0025] FIG. 10 is a top end view of the arterial closure device of
FIG. 6 showing the flared end partially closed.
[0026] FIG. 11 is a side view of the arterial closure device of
FIG. 6 showing the flared end.
[0027] FIGS. 12 and 13 are a cross-sectional side view and a top
view, respectively, of the arterial closure device of FIG. 1 having
an adhesive on the inner diameter and tissue engagement areas.
[0028] FIGS. 14 and 15 are a cross-sectional side view and a top
view, respectively, of the arterial closure device of FIG. 6 having
an adhesive on the inner diameter and tissue engagement areas.
[0029] FIGS. 16 and 17 are a cross-sectional side view and a top
view, respectively, of the arterial closure device of FIG. 1 having
grooves on the inner diameter to form a thinned or weakened
wall.
[0030] FIG. 18 is a side view of an angled arterial closure
device.
[0031] FIG. 19 is a side view of an angled arterial closure device
having a foldable extending member.
[0032] FIG. 20 is a side view of a deployment tool.
[0033] FIG. 21 is a side view of the deployment tool of FIG. 20
used to deploy a arterial closure device.
[0034] FIG. 22 is an end view of the deployment tool FIG. 20.
[0035] FIG. 23 is a side view of the deployment tool of FIG. 20
having an extended contacting member.
[0036] FIG. 24 is a side view of the deployment tool of FIG. 23
used to deploy a arterial closure device.
[0037] FIG. 25 is an end view of the deployment tool FIG. 23
[0038] FIG. 26 is a cross-sectional side view of a arterial closure
device having angled closure edges for compressing a vessel
wall.
[0039] FIG. 27 is a top view of the arterial closure device of FIG.
26.
[0040] FIG. 28 is a side view of the arterial closure device of
FIG. 26 being advanced through the skin into a vessel with the
closure edges deflected.
[0041] FIG. 29 is a side view of the arterial closure device of
FIG. 26 deployed and secured onto vessel wall with the closure
edges occluding the arteriotomy.
[0042] FIG. 30 is a side view of a arterial closure device.
[0043] FIG. 31 is an end view of the arterial closure device of
FIG. 30.
[0044] FIG. 32 is a perspective side view of a vascular connector
having a closable end.
[0045] FIG. 33 is an end view of the arterial closure device of
FIG. 32.
[0046] FIG. 34 is a side view of a liner having a longitudinal slot
for a arterial closure device.
[0047] FIG. 35 is an end view of the liner of FIG. 34.
[0048] FIG. 36 is a side view of a liner having a radial slot.
[0049] FIG. 37 is an end view of the liner of FIG. 36.
[0050] FIG. 38 is a side view of a plug-style arterial closure
device that includes an adhesive layer on the vessel contact
areas.
[0051] FIG. 39 is a side view of a plug style arterial closure
device that has limited vessel protrusion and includes an adhesive
on the vessel contacting areas.
[0052] FIGS. 40 and 41 are side views of the plug style arterial
closure device of FIG. 39 being deployed and deployed within a
vessel.
[0053] FIG. 42 is an end view showing the distal end of the
introducer inside a vessel.
[0054] FIGS. 43 and 44 are end views showing a flared arterial
closure device deployed along the introducer.
[0055] FIG. 45 is an end view showing the flared arterial closure
device of FIG. 43 deployed against the vessel to close the
arteriotomy.
[0056] FIGS. 46 and 47 are electrical schematics for a direct
resistive element heating circuit and an ohmic tissue heating
circuit.
[0057] FIG. 48 is a perspective view of a tube used to fabricate a
arterial closure device.
[0058] FIG. 49 is a perspective view of the tube of FIG. 48 showing
material being removed.
[0059] FIG. 50 is a side view of the tube of FIG. 48 with the
material removed.
[0060] FIG. 51 is a top view of the curved configuration.
[0061] FIG. 52 is a side view of the configuration of FIG. 51.
[0062] FIG. 53 is a perspective view of a fabric covering.
[0063] FIGS. 54-58 are side views showing the fabric covering of
FIG. 53 being mounted within the curved configuration of FIG. 51 to
form a arterial closure device.
[0064] FIG. 59 is a side view of a configuration having side arms
that fold over each other.
[0065] FIGS. 60 and 61 are front and cross-sectional side views of
a deployment tool for deploying the arterial closure device.
[0066] FIG. 62 is a cross-sectional side view of the deployment
tool of FIG. 60 having the arterial closure device within.
DETAILED DESCRIPTION
[0067] Referring to FIGS. 1-3, a vascular closure system 100
generally includes two components: a arterial closure device
("ACD") 105 and a deployment instrument 110. The ACD 105 is
slidably mounted to a vascular introducer 115 or other tubular
device, such as a catheter, advanced over a tube section 120 of the
introducer 115 using the deployment instrument 110, passed through
a percutaneous opening 125, and placed through an arteriotomy 130
in a vessel wall 133 into a blood vessel 135. The deployment tool
110 and the introducer 115 then are removed from the blood vessel
135 and out of the percutaneous opening 125.
[0068] Referring to FIGS. 4 and 5, the ACD 105 is generally
compliant, tubular, and includes a first member 140, a second
member 145, a connecting member 150 between the first member and
the second member, and an optional extending member 155 that
extends from the second member. A longitudinal channel 160 passes
between a first opening 165 in the extending member (or second
member if the extending member is not present) and a second opening
170 in the first member 140.
[0069] The ACD 105 is formed of a tubular structure of sufficient
length and thickness (e.g., a single wall thickness of between
0.005'' and 0.05'', and more particularly between 0.01'' and
0.02'') that can be advanced over the introducer 115, and through
the puncture site 125. The ACD 105 has sufficient rigidity to be
advanced through the puncture site 125 yet is compliant enough to
be compressed onto itself by the natural elasticity of the vessel
wall 133 after the introducer 115 is removed. Moreover, the
connecting member 150 can be configured to have a natural
elasticity such that when it is no longer mounted over the
introducer tube 120, it will return to its original smaller
diameter state. The ACD 105 may include, for example, longitudinal
sections of the tube where the wall thickness is thinner (e.g.,
connecting member 150) thereby creating creases or weakened areas
that receive the vessel wall 133. The creases would reduce the
amount of compressive force required to collapse the tube onto
itself. A design allowing tactile feedback may be used to determine
the proper insertion position (depth). The tactile feedback could
be accomplished by the ACD 105 having one or more rings of
increased wall thickness, an "hour glass" geometry, a thin, narrow,
then wide geometry, combination, or other means to provide an
abrupt change in the advancing force resistance during deployment.
The ACD 105 may be manufactured in many different French sizes, to
match the outer diameter of any commercial vascular introducers
115.
[0070] The ACD 105 is placed around the outside of any commercially
available introducer 115, or other device that is inserted into the
cardiovascular system (e.g., catheter, etc.), and positioned
adjacent to the proximal end of the introducer (i.e., near the
valve or luer fitting of the introducer). The introducer 115 then
is inserted into the vasculature using standard techniques. Prior
to removing the introducer 115, the tubular ACD 115 is advanced to
the skin, for example, by the physician manually advancing the ACD
along the tube 120. The deployment instrument 110 then is
positioned against or clipped onto the tuber 120, advanced to be in
contact with the proximal end (i.e., second member 145) of the ACD
105, and advanced through the skin such that at least the distal
most portion (e.g., first member 140) of the ACD is inside the
vessel 135. The ACD 105 is prevented from deforming or collapsing
during insertion by the rigidity of the tube 120. The tube 120 also
acts as a guide to position the ACD 105 through the puncture site
125 during its advancement and deployment. When the introducer 115
is removed, the deployment instrument 110 is held in position and
still in contact with the ACD 105 preventing the ACD from coming
out of the vessel 135 along with the introducer. Once the
introducer 115 is completely removed, the ACD 105 is compressed
together due to the elastic recovery of the vessel wall 133,
achieving hemostasis and effectively sealing the arteriotomy 150
and puncture site 125.
[0071] The ACD 105 can be partially or completely fabricated from a
biocompatible material, such as expanded polytetrafluoroethylene
(ePTFE), polyester, polyurethane, silicone, Dacron, urethane,
and/or a composite or combination of these or other suitable
materials. The ACD 105 also can be partially or completely
fabricated from a biodegradable/bioabsorbable material, including
modified cellulose, collagen, fibrin, fibrinogen, elastin or other
connective proteins or natural materials, polymers or copolymers
such as polylactide [poly-L-lactide (PLLA), poly-D-lactide (PDLA)],
polyglycolide, polydioxanone, polycaprolactone, polygluconate,
polylactic acid (PLA), polylactic acid-polyethylene oxide
copolymers, poly(hydroxybutyrate), polyanhydride, polyphosphoester,
poly(amino acids), poly(alpha-hydroxy acid) or related copolymers
of these materials as well as composites and combinations thereof
and combinations of other biodegradable/bioabsorbable
materials.
[0072] The ACD 105 also can be partially or completely fabricated
from materials that swell, or expand when they are exposed to a
fluid, such as blood, or another fluid, for example, that can be
added by the physician to cause the material to swell. These
materials include hydrophilic gels (hydrogels), regenerated
cellulose, polyethylene vinyl acetate (PEVA), as well as composites
and combinations thereof and combinations of other biocompatible
swellable or expandable materials.
[0073] The ACD 105 can be made using several methods and processes
including extrusion, molding (i.e., injection molding or other
known molding techniques), casting, dip coating, spraying, adhesive
bonding, ultra-sonic welding, composite fabrication techniques, and
combinations of these and/or other similar methods and
processes.
[0074] The ACD 105 also can have a biocompatible contact adhesive
or other material within the longitudinal channel 160 so that when
the longitudinal channel is compressed within the arteriotomy 130,
the adhesive bonds the inside surfaces of the longitudinal channel
together. This assists or expedites the sealing of the arteriotomy.
Additionally, bonding materials can be used on the outside of the
ACD 105, for example, on the outer surface of the first member 140,
the second member 145, the connecting member 150, and or the
optional extending member 155. In particular, the bonding material
is especially useful where the ACD contacts the vessel wall 133
defining the arteriotomy 130.
[0075] The biocompatible contact adhesive adhesive/bonding
compounds/solutions could be added during the manufacturing
process, just prior to deployment, or after the device has been
deployed. The bonding materials could be in the form of a liquid,
semi solid, or solid. Suitable bonding materials include gels,
foams and microporous mesh. Suitable adhesives include acrylates,
cyanoacrylates, epoxies, fibrin-based adhesives, other biological
based adhesives, UV light and/or heat activated or other
specialized adhesives. The adhesive could bond on initial contact,
or longer, to allow repositioning if desired. The preferred
adhesive may be a crystalline polymer that changes from a non-tacky
crystalline state to an adhesive gel state when the temperature is
raised from room temperature to body temperature. Such material is
available under the trade name Intillemer.TM. adhesive, available
from Landec Corp. as well as composites and combinations thereof
and combinations of other materials. Suppliers of biocompatible
adhesives include, but are not limited to, Plasto (Dijon, France),
Haemacure (Montreal, Canada), Cohesion (Palo Alto, Calif.),
Cryolife (Kennesaw, Ga.), TissueLink (Dover, N.H.), and others. To
increase the work time of the adhesive or allow repositioning of
the vascular coupler after it has been deployed, the adhesive can
be blended with a material, such as a starch or other material,
that retards or delays bonding to allow repositioning of the
coupler after it has been deployed. A degradable coating can be
placed over the adhesive coating so that it degrades and exposes
the adhesive. Other adhesives are understood to include
composites-based adherents and combinations of the above materials
and other suitable materials as are known in the art.
[0076] To improve later detection of the ACD 105, it can be
fabricated from materials that include one or more radiopaque
materials, such as barium sulfate, bismuth trioxide, or other any
other radiopaque material. The radiopaque material is added to the
materials from which the ACD 105 is fabricated or to the bonding
materials that are placed in, on, or around the ACD.
[0077] Referring to FIGS. 6-11, a second implementation of a
arterial closure device is shown as a arterial closure device
("ACD") 200. The ACD 200 includes a first member 205, a second
member 210, and an optional extending member 215 that extends from
the second member. A longitudinal channel 220 passes between a
first opening 225 in the extending member (or second member if the
extending member is not present) and a second opening 230 in the
first member 205. The ACD 200 is implanted within an arteriotomy
130 in a manner similar to the implantation of the ACD 105.
However, the ACD 200 does not include a member that is
substantially in contact with the inner wall of the vessel 135.
Instead, the ACD has a flare, or two or more short slits 235 in the
side wall of the first member 205. The flare or slits 235 are
designed to open or flare around the catheter or introducer 120
when advanced to the top of the vessel puncture site (FIG. 8). The
materials from which the ACD 200 or the second member 205 are
fabricated may be a very elastic material such that when around the
introducer it expands and when advanced beyond the end of the
introducer, it contracts such that the individual flares pinch or
otherwise catch the edges of the arteriotomy or punctured vessel
and pull them together while contracting (FIG. 9). This action is
intended to close the arteriotomy 130 and create hemostasis. The
inside of the flared section 235 of the ACD 200 may have a
biocompatible contact adhesive or other bonding material, as
described above, that further secures the ACD within the
arteriotomy and to the vessel 135, and, in particular the second
member 210 to the top or outer surface of the vessel.
[0078] As indicated above, the adhesive or bonding materials can be
implemented on any of the above ACDs. For example, referring to
FIGS. 12 and 13, the ACD 105 has an adhesive or bonding material
270 on the inner diameter and tissue engagement areas. Similarly,
referring to FIGS. 14 and 15, the ACD 200 has the adhesive or
bonding material 270 on the inner diameter and tissue engagement
areas. In this manner, adhesive 270 will close the respective
longitudinal channel 160, 200 of the ACD 105, 200 to reduce or
eliminate seepage blood. Moreover, the adhesive 270 around the
tissue contacting areas will bond the ACD to the vessel wall to
reduce or eliminate seepage of blood through those regions.
[0079] Referring to FIGS. 16 and 17, the ACD 105 can have the inner
diameter of the longitudinal channel 160 modified to include ridges
280 and channels 285 that weaken or thin the wall section of the
ACD. In this manner, the inner diameter of the longitudinal channel
160 can be expanded or reduced depending upon the circumferential
pressure exerted against the ACD. For example, when passing the
introducer through the longitudinal channel the inner diameter will
be expanded. When the introducer is subsequently removed, the inner
diameter is reduced because of the natural elastic recoil
properties of the ACD. In this manner, the seepage of blood through
the longitudinal channel is reduced or eliminated. Moreover, the
surfaces of the inner diameter of the longitudinal channel can be
coated with an adhesive, as described above, to further ensure that
the inner diameter is closed.
[0080] The ACDs described herein also can include one or more
therapeutic agents that affect healing at the site where the device
is deployed. The agent(s) can be incorporated into the structure
forming the device and/or incorporated into a coating. Such
therapeutic agents may include, but are not limited to,
antithrombotics (such as anticoagulants), antimitogens,
antimitotoxins, antisense oligonucleotides, gene therapy solutions,
nitric oxide, and growth factors and inhibitors. Direct thrombin
inhibitors that may be beneficial include Hirudin, Hirugen,
Hirulog, PPACK (D-phenylalanyl-L-propyl-L-arginine chloromethyl
ketone), Argatreban, and D-FPRCH.sub.2 Cl
(D-phenylalanyl-L-propyl-L-arginyl chloromethyl ketone); indirect
thrombin inhibitors include Heparin and Warfarin (coumadin).
Alternatively, a clot promoter may be used, such as protamine
sulphate or calcium hydroxide. Additional therapeutic materials
include, aspirin, dexamethasone, dexamethasone phosphate,
streptokinase, tocopherol, TPA, urokinase, paclitaxel (Taxol),
actinomycin, rapamyacin, or other. Sirolimus, or other antibiotics
may also be used. The therapeutic compounds/solutions may be
blended with the device base materials during fabrication, applied
just prior to deployment, or after the device has been deployed.
Additionally, the therapeutic materials may be located on, through,
inside, or combination of the device in holes, grooves, slots or
other indentation to allow elution of the therapeutic compound(s).
Post device fabrication coating methods include, but are not
limited to, dipping, spraying, brushing, submerging the devices
into a beaker containing a therapeutic solution while inside a
vacuum chamber to permeate the device material, etc.
[0081] The geometry of the ACDs described herein is shown for
illustration purposes as being generally round. However, they can
be of any other geometry, such as oval, elliptical, rectangular,
square, ridged, or a combination of shapes. The ACD has been
illustrated as forming a generally perpendicular angle with the
vessel wall once deployed. Nonetheless, the inventors intend the
configuration to be at any suitable angle, such as between
30.degree. and 60.degree., or, for example, 45.degree. or as
otherwise desired. A range of angles of the ACD can be available
and the physician can choose the appropriate ACD based on the angle
at which the introducer is introduced into the vessel. For example,
referring to FIG. 18, a ACD 290 is formed to have the extending
member 155 extending at an angle of approximately 45.degree. from
the second member 145. In addition, the first member 140 and the
second member 145 are longitudinally offset. This configuration is
designed to cause the extending member 155 to follow the path
created by the introducer. Referring also to FIG. 19, the ACD has a
second member 292, a foldable extending member 294, and a groove
296 positioned between the second member 292 and the folding
extending member 294. In this manner, the extending member 294 can
be folded or bent over to be less obtrusive and to close off the
flow of blood through the ACD.
[0082] Referring to FIGS. 20-22, a deployment tool 300 is designed
to engage or otherwise contact the proximal edge, or other edge, of
the ACD. The tool 300 is generally handheld and includes a handle
305, an extension 310, and a contacting section 315 that clips
onto, or otherwise contacts the outside of the introducer and mates
with the ACD. The contacting section 315 has sufficient length to
advance the ACD through the tissue to the desired position on the
vessel. The handle 305 or grasping section can be, for example,
round, rectangular, elliptical, or a combination of shapes or other
shape that fit comfortably in the hand. The contacting section 315
can have a cross-sectional geometry of a partially open tube having
more than 50% diameter coverage, so that it can clip onto, and
slide over the outer diameter of the introducer.
[0083] Referring also to FIGS. 23-35, the deployment tool can
include an additional extension 320 that is configured to fit
around the extending member 155 and mate with the second member
145. The extension 320 can be attached to the introducer after the
introducer is positioned within the artery.
[0084] The deployment tool 300 can be made partially or completely
from several different polymer materials including polycarbonate,
nylon, polyethylene, polytetrafluoroethylene (PTFE),
fluoroethylene-propylene (FEP) or polyfluoroacrylate (PFA),
polyester ether ketone (PEEK), polyamide, polyimide,
polyethyleneteraphthalate (PET), combination or other material able
to withstand sterilization processing. The tool can also be made
partially or completely from several different types of metals
including stainless steel; spring metal alloys such as Elgiloy.TM.,
Inconel.TM.; superelastic/shape memory alloys such as Nitinol
(NiTi) as well as composites and combinations thereof and
combinations of other materials.
[0085] The deployment tool 300 can be made using several methods
and processes including extrusion, molding (injection and other),
casting, adhesive bonding, ultrasonic welding as well as
combinations thereof and combinations of other methods and
processes.
[0086] Modifications of the deployment tool 300 are possible. For
example, the proximal edge of the ACD (i.e., of the extending
member 155 or the second member 145) and the distal edge or other
portion of the advancement tool 300 may have interlocking
geometries to aid and/or control the position of the ACD during
advancement along the introducer. The engagement/contact section
315, 320 of the tool 300 may have a cross-sectional geometry of a
complete circle that is designed to split away from the introducer
once the ACD has been advanced and deployed. Splitting can be
accomplished by having weakened areas in the wall of the tubing,
such as linear perforations, or linear scores. This version would
require that the deployment tool be back loaded onto the introducer
before the ACD is placed onto the introducer and prior to insertion
into the vessel.
[0087] The inside, concave section of the contact section 315, 320
may be coated with a hydrophilic or other lubricious material to
reduce the friction during advancement and deployment of the ACD.
In addition to the deployment tool 300 contacting the proximal edge
of the ACD, the contacting section 315, 320 of the tool can be
lengthened and designed to further attach to and compress the
distal edge of the ACD, thereby providing additional support during
insertion and deployment into the vessel.
[0088] Referring to FIGS. 26-29, a ACD 350 includes a first angled
closure edge 355, a second angled closure edge 360, an extending
member 365, and a connection member 370 between the first and
second angled closure members. The first angled closure edge 355
and the second angled closure edge are generally directed at each
other such that they define a narrow opening 375 through which the
vessel wall 133 is received. The ACD 350 is deployed over the
introducer tube section 120 using, for example, the deployment tool
300. As illustrated in FIG. 28, the second angled closure edge 360
is deflected away from the first angled closure edge 355. The
deflection can be caused, for example, by the contacting section
320 surrounding the second angled closure edge 360. In this manner,
when the deployment tool 300 is removed, the second angled closure
edge 360 deflects back to compress the vessel wall 133 between the
angled closure edges 355, 360. The angled closure edges 355 and 360
are formed, for example, from a flexible member, such as a polymer,
superelastic/shape memory material, or a combination of the two.
For example, the superelastic/shape memory member can be coated
with a polymer.
[0089] Referring to FIGS. 30 and 31, a ACD 400 includes a threaded
section 405 and an extending section 410. The threaded section 405
includes threads 415 mounted on and between a first member 420 and
a second member 425. The extending section 410 includes a
longitudinal channel 430 that includes a distal shaped channel 435.
A deployment tool having a mating shaped distal end is inserted
into the longitudinal channel 430 such that it mates with the
distal shaped channel 435. By rotating the deployment tool, the ACD
can be threadably inserted into the arteriotomy.
[0090] In general, the distal edge of the ACD 400 is designed to
engage the opening of the arteriotomy or puncture site and protrude
to a specific depth based on how many times the ACD was advanced,
twisted or turned. The ACD 400 may have a stop 437 to limit how far
the device protrudes into the vessel. The same "screw" type distal
edge could be used on a hemostatic plug, made from a solid piece of
material, rather than a tube structure. A deployment tool would be
needed that has, for example, a grasping distal end for insertion
into the vessel.
[0091] The ACD 400 can be modified to include a longitudinal
channel that pass through the entire length of the device and
deployed over a introducer. In this case, the deployment tool and
the proximal edge of the ACD would have a mating geometry such that
the deployment tool is rotated to threadably insert the ACD through
the arteriotomy.
[0092] Referring to FIGS. 32 and 33, a ACD 450 includes a tissue
contacting member 455 and an extending member 460. A longitudinal
channel 463 passes through the ACD. The extending member 460
includes a longitudinal slot 465 and a circumferential channel 470
in which a contracting member 475 is received. The contracting
member 475 tends to close the longitudinal channel 463 unless kept
open, for example, by an introducer 115 within the channel. In this
manner, when the ACD 450 is deployed within the arteriotomy and the
introducer is removed, the longitudinal channel is closed, which
prevents or limits blood flow or seepage through the channel. The
ACD can be formed from any of the materials described above. For
example, the ACD can be formed from a polymer and the extending
member can be formed from a flexible material such as a
polyurethane/Dacron composite that easily collapses as a
consequence of contraction property of the contracting member
475.
[0093] Referring to FIGS. 34 and 35, a ACD inner liner 480 is
formed as a simple slotted tube 485 that includes a slot 490 along
its length that functions a means for side access onto the
introducer, after the introducer has been inserted into the vessel.
The slot 490 can be formed as a longitudinal or radial slit,
illustrated below. The ACD inner liner can be opened sufficiently
to attach onto the introducer from the side. Any configuration of
the ACDs described herein is built around the ACD liner 480 with a
slot formed within the ACD. The tube 485 optionally can extend from
the ACD and then be clamped at the proximal end once the ACD liner
480 and ACD are deployed.
[0094] Referring to FIGS. 36 and 37, a ACD liner 500 includes a
tube 505 that includes a radial slot 510 along an extending member
515 and through a first member 520 and a second member 525. The ACD
inner liner 500 is sufficiently openable to be threaded onto the
introducer from its side. Any configuration of the ACDs described
herein can be built around the ACD liner 500 with a slot formed
within the ACD. The tube 505 optionally can extend from the ACD and
then be clamped at the proximal end once the ACD liner 500 and ACD
are deployed.
[0095] Referring to FIGS. 38-41, a plug style ACD 550 that is
similar to ACD 105 includes a channel 555 into which a deployment
tool 552 is inserted to deploy the ACD through an arteriotomy to
close the arteriotomy. The ACD includes an adhesive layer 560 for
bonding to the tissue. The ACD 550 differs from the ACD 105 in that
the channel 555 does not extend the entire length of the ACD. A ACD
570 (FIG. 39) is similar to the ACD 550 except that it has limited
vessel protrusion, similar to the ACD 200 above. The ACD 550, 570
is placed into the arteriotomy and held briefly for an adhesive
bond to form. The deployment device 552 then can be removed.
[0096] The distal end of the deployment tool 552 also can have a
grasping feature to grasp the proximal end of the plug ACD during
deployment and to release after the plug ACD has been seated in or
is on the vessel, and able to release when the tool is being
withdrawn.
[0097] Referring to FIGS. 42-45, a ACD can have a distal end
geometry, which once positioned at the puncture site, is designed
to compress the vessel wall for increased securement and sealing.
For example, a ACD 600 may have a flare 605, or two or more
longitudinal slits in the side of the tube, that are designed to
open, or flare apart when advanced and in contact with the top of
the vessel puncture site (i.e., arteriotomy). The ACD 600 can be
made from a very elastic material and/or a superelastic/shape
memory material such that when the introducer is removed, the
flares or slits will pinch, or otherwise bring the edges of the
punctured vessel together, effectively creating hemostasis. The
inside of the flared section of the closure device could have
biocompatible contact adhesive, other bonding material, and/or
small barbs or protrusions that may assist in securing the device
to the top of the vessel wall.
[0098] Referring to FIGS. 46 and 47, heat can be used to assist
with, or as an adjunct to, the process by recovering the ACD,
activating (e.g., causing to flow, etc.) a hemostatic material to
the puncture site that assists in sealing (e.g., through vessel
contraction including the denaturing and reformation of collagen at
the site) or accelerate healing, or a combination of these or other
beneficial effects. Direct resistive element heating (FIG. 46) or
ohmic tissue heating (FIG. 47) can be utilized. Biocompatible
electrode materials (e.g., gold, platinum, and other suitable
materials) can be mixed with the base material of the ACD as a
powder during manufacturing, or as a wire, strip, or other
geometry, added onto any surface of the device, and connected to a
suitable (i.e., electrical and biocompatible) conductor. For ohmic
tissue heating, one conductor 620 is connected to an RF power
source. Another conductor is connected to a ground pad 630 placed
on the patient's body, and also connected to the power source. For
direct resistive element heating, both conductors from the power
source 625 are connected to an electrode 635. Once the sealing of
the puncture site has occurred, a twisting, cutting, or other
manipulative action removes the conductor previously attached to
the closure device. Alternatively, a special tip is placed over a
standard electro surgical tool (e.g., Bovie) to insert through the
skin and make contact with the closure device, tissue or both.
[0099] Alternative versions of the closure device may utilize an
electrode that is formed by ion deposition, sputter coating,
spraying, dip coating, adhesive, combination or other method or
design.
[0100] Referring to FIGS. 48-58, a superelastic/shape memory ACD
700 is made from a superelastic/shape memory sheet or tube 705. The
sheet or tube 705 is etched, cut, or otherwise machined to remove
material 710 (FIG. 49) to leave a starting configuration 715 (FIG.
50). The method of removing the material may be, for example,
photo-etching and/or laser or chemical cutting. The starting
configuration includes first extending members 720, second
extending members 725, and a connecting member 730 between the
first and second extending members. The first and second extending
members 720 and 725 then are bent and curved (FIGS. 51 and 52). The
first and second extending members are curved to mate with the
inner and outer surface, respectively, of a vessel. For example,
longer first and second extending members 720a and 725a are bent to
be generally perpendicular to the connecting member 730 and have a
curvature that is similar to that of the length dimension of a
vessel wall. The shorter first and second extending members 720b
and 725b are bent to have a radius of curvature that is similar to
that of the radius of curvature of the circumference of a vessel
wall. The shapes of the first and second extending members 720, 725
are set using known techniques of imparting shapes in
superelastic/shape memory materials, as described in further detail
below.
[0101] A fabric covering 740 (FIG. 53), such as Dacron, then is
mounted to the curved configuration 715. The covering 740 includes
distal side openings 745 and proximal side openings 750. A
longitudinal channel 755 passes between a distal opening 760 and a
proximal opening 765. The covering 740 is pulled distal end through
the curved configuration 715 and the extending members 720 are
straightened from their retracted state and passed through the
distal side openings 745 (FIG. 54). The covering 740 then is pulled
back such that the distal side openings 745 are tight against the
first extending members 720 (FIG. 55). The first extending members
720 then are allowed to expand back to their retracted state. The
second extending members 725 then are straightened from their
retracted state and passed through the proximal side openings 750
(FIG. 56). The second extending members 725 then are allowed to
expand back to their retracted state, thereby trapping a proximal
end 760 of the covering against the connecting member 730 between
the first and second extending members 720, 725 (FIGS. 57 and 58).
The longitudinal channel 755 passes through the covering 740 and
the shaped configuration 715.
[0102] Referring to FIG. 59, the second extending members 725b can
be configured to curve back over and under the opposite second
extending member 725b. Thus, instead of curving against the outer
circumference of the vessel in which the device is implanted, the
second extending members 725b function to close the longitudinal
channel 755 when they are in their retracted position. The covering
740 is mounted to the curved configuration 715 as described above.
The second extending members 725b are kept in a straightened
position because of the introducer or catheter that passes through
the longitudinal channel 755. When the introducer or catheter is
removed, the second extending members 725b return to their
retracted position, thereby closing or partially closing the
longitudinal channel 755. The covering 740 also contributes to the
closure of the longitudinal channel 755 and reduction or
elimination of blood leakage or seepage through the longitudinal
channel.
[0103] Referring also to FIGS. 60-62, the ACD 700 is deployed using
a deployment tool 775. The deployment tube includes a handle 780,
an extension 783, a guide 786, and a pusher tuber 789. The guide
786 extends from the extension 783 and includes a first
longitudinal channel 791 and a longitudinal ridge 792 that passes
along the inner surface of the first longitudinal channel 791. The
pusher tube 789 is slidably mounted within the first longitudinal
channel 791 and includes a second longitudinal channel 793, a
pusher surface 794, and a groove 796 that is configured to slide
over the longitudinal ridge 792. The guide 786 and the pusher tube
789 include longitudinal slots 797, 798 so that the deployment tool
775 can be placed around the catheter or introducer. With the ACD
700 positioned over a catheter or introducer 120, and positioned
within the longitudinal channel 791 in the guide 786, the physician
pushes the ACD 700 along the introducer 120 into the vessel using
the pusher tube 789. Of course, the ACD can be placed within an
arteriotomy using other deployment tools or even by hand.
[0104] The ACDs herein may contain a metallic braid, coil, sheet,
strip, wire, rod, or other configuration on the inner diameter,
outer diameter, within, and/or a combination of these. The metallic
material could be made from superelastic/shape memory alloys such
as Nitinol. The metallic braid or coil could be annealed in one
configuration during manufacture and processed and packaged in
another configuration. When the material is exposed to normal body
temperature (i.e., 37.degree. C.), it will be set to either expand
apart or contract inward depending on the design and annealed
geometry (diameter). This characteristic may assist with the
closure of the ACD.
[0105] It is important to understand basic terminology when
describing metals with elastic, superelastic, or shape memory
behavior. Elasticity is the ability of the metal, under a bending
load, for example, to deflect (i.e., strain) and not take a
permanent "set" when the load (i.e., stress) is removed. Common
elastic metals can strain to about two percent before they set.
Superelastic metals are unique in that they can withstand up to
about ten percent strain before taking a set. This is attributed to
a "stress-induced" phase change within the metal to allow it to
withstand such dramatic levels of strain. Depending on the
composition of the metal, this temperature that allows such a phase
change can vary. And if the metal is "set" at one temperature, and
then the temperature is changed, the metal can return to an "unset"
shape. Then, upon returning to the previous "set" temperature, the
shape changes back. This is a "shape-memory" effect due to the
change in temperature changing the phase within the metal.
[0106] Elasticity is a key feature of superelastic materials. When
a metal is loaded (i.e., stressed) and undergoes, for example,
bending, it may deflect (i.e., strain) in a "springy" fashion and
tend to return to its original shape when the load is removed, or
it may tend to "set" and stay in a bent condition. This ability to
return to the original shape is a measure of the elasticity or
"resilience" of the metal. This ability for a metal to be resilient
is desirable for such things as springs, shock absorbing devices,
and even wire for orthodontic braces where the ability to deflect,
but not deform (i.e., set) is important to maintain an applied
force.
[0107] If, under a bending load, the metal takes a set, it is said
to have plastically (versus elastically) deformed. This is because
the imposed stress, produced by the bending load, has exceeded the
"yield strength" (stress) of the metal. Technically, this level of
stress that produces a set, is referred to as the "elastic limit",
but is about the same as the yield strength. If the applied load
increases past the yield strength of the metal, it will produce
more plasticity and can eventually break. The higher the yield
strength of the metal, the more elastic it is. "Good" elastic
metals can accommodate up to about two percent strain prior to
taking a set. But this is not the only factor governing
"elasticity".
[0108] Another factor that determines the ability of a metal to
deflect to a given, desired amount, but not take a set, is the
"elastic modulus", or often called the modulus of elasticity. The
modulus of the metal is an inherent property. Steels, for example,
have a relatively high modulus (30 msi) while the more flexible
aluminum has a lower modulus of about 10 msi. The modulus for
titanium alloys is generally between 12 and 15 msi.
[0109] Resilience is the overall measure of elasticity or
"spring-back ability" of a metal. The ratio of the yield strength
divided by the modulus of the metal is the resilience. Although it
is one thing for a metal to be resilient, it must also have
sufficient strength for the intended service conditions.
[0110] As discussed above, when a metal is loaded, each increment
of load (stress) produces a given increment of deflection (strain)
within the metal. And the metal remains elastic if the applied is
below the yield stress. However, there is a unique class of metal
alloys that behave in an even more elastic manner. These are the
"superelastic" metals, where, for a given applied stress (load)
increment, the strain in the metal can reach 5 or 6 percent or more
without taking a set. In these types of metals, the overall strain
required to produce a set can reach an impressive 10 percent. This
phenomenon is related to a phase change within the metal, and which
is induced by the applied stress. This "stress-induced" phase
change can also allow the metal to be set at one temperature and
return to another shape at another temperature. This is a
"shape-memory" effect, discussed below.
[0111] The most common superelastic metal, used in many commercial
applications, is an alloy comprised of about equal parts of nickel
(Ni) and titanium (Ti), and has a trade name of "Nitinol". It is
also referred to as "NiTi". By slightly varying the ratios of the
nickel and titanium in Nitinol, the stability of the internal
phases in the metal can be changed. Basically, there are two
phases: (1) an "austenite" phase and (2) a lower-temperature,
"martensite" phase. When the metal is in an austenitic phase
condition and is stressed, then a stress-induced martensite forms,
resulting in the super-elasticity. This is reversible, and the
original shape returns upon release of the applied stress.
[0112] In general, the Ni-to-Ti ratio in the Nitinol is selected so
that the stress-induced martensite forms at ambient temperatures
for the case of super-elastic brace and support devices, which are
used in ambient conditions. The specific composition can be
selected to result in the desired temperature for the formation of
the martensite phase (Ms) and the lower temperature (Mf) at which
this transformation finishes. Both the Ms and Mf temperatures are
below the temperature at which the austenite phase is stable (As
and Af). The performance of an ACD can be further enhanced with the
use of superelastic materials such as Nitinol. The superelasticity
allows for greatly improved collapsibility, which will return to
its intended original shape when the introducer (or catheter) is
removed from the inside of the ACD. The high degree of flexibility
is also more compatible with the stiffness of the engaged
vessel.
[0113] By manipulating the composition of Nitinol, a variety of
stress-induced superelastic properties can result, and over a
desired, predetermined service temperature range. This allows the
metal to behave in a "shape-memory" or "shape recovery" fashion. In
this regard, the metal is "set" to a predetermined, desired shape
at one temperature when in a martensitic condition, and which
returns to the original shape when the temperature is returned to
the austenitic temperature.
[0114] The shape memory phenomenon occurs from a reversible
crystalline phase change between austenite and the
lower-temperature martensite. In addition to this transformation
occurring from an induced stress as described previously, it can,
of course, also change with temperature variations. This
transformation is reversible, but the temperatures at which these
phase changes start and finish differs depending on whether it is
heated or cooled. This difference is referred to as a hysteresis
cycle. This cycle is characterized by the four temperatures
mentioned previously, As, Af, Ms, and Mf. Upon heating from a
lower-temperature martensite, the transformation to austenite
begins at the As, and will be fully austenite at Af. And upon
cooling, austenite will begin to transform back to martensite at
the Ms temperature, and become fully martensitic at the Mf. Again,
the specific composition of the alloy can result in a desired
combination of these four transformation temperatures.
[0115] In the malleable martensitic state, the alloy can be easily
deformed (set). Then upon heating back to the austenitic
temperature, the alloy will freely recover back to its original
shape. Then if cooled back to the martensitic state, the deformed
shape reforms. The typical sequence of utilizing this shape memory
property is to set the shape of, for example, a stent or
anastomosis connector, while in the higher-temperature austenitic
state. Then, when cooled, deform the martensite material, and then
heat to recover the original shape.
[0116] Based on the background information provided above, it can
be seen that if the Nitinol material requires an exceptionally
tight bend, and one that would normally exceed the elastic limit of
the material and thus permanently deform it, a bend can be placed
in the device and the device annealed to relieve bending stresses
within the device. Following this first bend, the device can be
bent further to produce an even sharper bend, and then re-annealed
to alleviate the stress from this additional bending. This process
can be repeated to attain the desired, sharp bend or radii that
would otherwise permanently deform the device if the bend were
attempted in a single bending event. The process for recovery from
the position of the most recent bend is then performed as described
above.
[0117] Although the example of Nitinol, discussed above, is, by far
the most popular of the superelastic metals, there are other alloys
that can also exhibit superelastic or shape-memory behavior. These
include the following:
[0118] Copper--40 at % Zinc
[0119] Copper--14 wt % Aluminum--4 wt % Nickel
[0120] Iron--32 wt % Manganese--6 wt % Silicon
[0121] Gold--5 to 50 at % Cadmium
[0122] Nickel--36 to 38 at % Aluminum
[0123] Iron--25 at % Platinum
[0124] Titanium--40 at % Nickel-10 at % Copper
[0125] Manganese--5 to 35 at % Copper
[0126] Titanium--49 to 51 at % Nickel (Nitinol)
[0127] Nitinol, because of the large amount of titanium in the
composition, has been the only FDA approved superelastic/shape
memory alloy for medical implant devices. The corrosion resistance
of Nitinol is superior to that of commonly used 3161 stainless
steel, and, if surface oxidized or passivated carefully, can reach
corrosion resistance comparable to the most popular titanium
implant alloy, Ti6Al4V. Similarly, the metal piece can be
electropolished to improve its biocompatibility and blood
compatibility. Biocompatibility studies have routinely showed
Nitinol as a metal with suitable biocompatibility for medical
device applications.
[0128] In summary, there are various ways of describing elasticity,
but the main criterion is the ability of the metal to return to its
initial, pre-loaded shape. Some metals can only deflect a couple
percent and remain elastic while others, such as superelastic
Nitinol, can deflect up to about ten percent. Nitinol is also
biocompatible and corrosion resistant. This unique combination of
properties allows a device made of Nitinol, such as an arterial
closure device, to be fully collapsed within a deployment tool and
be subsequently released, at a particular site within the vessel,
to form its intended service shape.
[0129] Materials other than superelastic/shape memory alloys may be
used as reinforcements provided they can be elastically deformed
within the temperature, stress, and strain parameters required to
maximize the elastic restoring force thereby enabling the tubular
closure device to recover to a specific diameter and/or geometry
once deployed inside, over, or on top of the vessel or other
location. Such materials include other shape memory alloys, spring
stainless steel 17-7, other spring metal alloys such as
Elgiloy.TM., Inconel.TM., superelastic polymers, etc.
[0130] When thermally forming superelastic/shape memory
reinforcements, the superelastic/shape memory material(s),
previously cut into the desired pattern and/or length, are stressed
into the desired resting configuration over a mandrel or other
forming fixture having the desired resting shape of the tubular
plug, depending on the vessel size or other location where the ACD
or plug is intended to be used, and the material is heated to
between 300 and 650.degree. Celsius for a period of time, typically
between 30 seconds and 30 minutes. Once the volume of superelastic
material reaches the desired temperature, the superelastic material
is quenched by inserting into chilled water or other fluid, or
otherwise allowed to return to ambient temperature. As such, the
superelastic reinforcements are fabricated into their resting
configuration. The superelastic/shape memory reinforcements may be
full or partial length or width of the ACD or tubular plug.
[0131] Any metal or metal alloy, such as a superelastic/shape
memory alloy that comes in contact with blood and/or tissue can be
electropolished. Electropolishing may reduce platelet adhesion
causing thrombosis, and encourage endothelization of the exposed
metallic areas. Electropolishing also beneficially removes or
reduces flash and other artifacts from the fabrication of the
device.
[0132] Superelastic/shape memory materials, such as tubular,
rectangular, wire, braid, flat, round, combination or other
structures also can be used in the design of the closure device, to
assist with grasping, contacting, bringing tissue together,
sealing, or other desired function. When used as a hollow conduit
or reinforcement to a conduit, the superelastic/shape memory
materials could be used to resist compressive closure and act as a
flexible reinforcing strain relief to prevent kinking and to
prevent the conduit from closing.
[0133] Numerous modifications and/or additions to the
above-described embodiments and implementations are readily
apparent to one skilled in the art. It is intended that the scope
of the present embodiments and implementations extend to all such
modifications and/or additions and that the scope of the present
embodiments and implementations is limited solely by the
claims.
[0134] For example, the engagement/contact section of the
deployment tool can have a cross sectional geometry of a complete
circle that may be designed to split away from the introducer once
the closure device has been advanced/deployed. Splitting could be
accomplished by having thinned or weakened areas in the wall of the
deployment device tubing, such as linear perforations, or linear
scores, combination, or other perforation configuration. This
version would require that the deployment tool be back loaded onto
the introducer before the closure device is placed onto the
introducer and prior to insertion into the vessel.
[0135] The deployment tool can be a clip-on tool, can compress the
device to reduce the cross sectional profile prior to insertion
and/or may include a constraining sheath to reduce a section, or
sections of the device during insertion to the target site. This
version would be particularly useful for bringing two tissue walls
together while yet providing a conduit between the tissues.
[0136] The proximal end of the ACDs described herein may be closed
using hemostats, or other tools, by pinching the end together until
the inner diameter bonds, or compresses together. Adhesive may be
used to assist in the closure of the device.
[0137] The proximal edge of the closure device and the distal (or
other) edge of the advancement/deployment tool can have
interlocking geometries to aid control during advancement
(particularly when inserting by twisting or turning while advancing
into the vessel).
[0138] The proximal edge or end of the closure device may have a
collar made of a superelastic/shape memory material, an elastic
combination of materials or suitable elastic materials that would
compress the end of the device together once the introducer is
removed from the inner diameter of the closure device. As
previously mentioned, the closing and sealing of the device may be
enhanced with an adhesive, swellable material, or other coating or
layer.
[0139] The closure means can be other than a tubular structure,
such as a plug. A special introducer, having multi-lumens, one for
the catheter or other device, and at least one for the hemostatic
plug material. The hemostatic material, and matching geometry
plunger would be inserted into the proximal end of the special
introducer. As the plunger is advanced, the hemostatic material is
advanced into position and the introducer is withdrawn from the
vessel.
[0140] The basic device, system and method can be sized and
configured for medical devices other than vascular introducers,
such as guide wires, catheters, laparoscope, endoscope, trocar,
cannula, electrode wire, or other.
[0141] Using the tubular closure device, especially when made from
swellable material, as a reversible sterilization method for women
by occluding the fallopian tubes, and men by occluding the vas
ducts or tubes.
[0142] A modified version of the device and system can be used for
the closure of septal defects in the heart, as well as anywhere
else in the body. For this, as well as other additional
applications, the clip on section of the deployment tool would be
modified to fit onto the catheter, and be long enough (such as,
e.g., full catheter length) to be remotely advanced from the
proximal end of the catheter. The deployment tool also may be
modified and used to compress the device during insertion into the
body to thereby reduce the cross-sectional profile during
insertion. The deployment method may be enabled by longitudinal
movement, manipulation, or retraction of the deployment tool away
from the closure device, which removes the compression of the
device and allows the device to expand and fill in the opening,
such as a septal defect.
[0143] The ACDs described herein can be used for cardiovascular
applications where hemostasis (temporary or permanent) is desired.
Additionally, the ACDs can be used with simple modifications for
any tubular, duct, organ, hollow body cavity, or other structures
or tissues, where temporary or permanent sealing or plugging is
needed, or alternatively, where a conduit or conduit reinforcement
is desired. For conduit or conduit reinforcement applications, the
material and design used thereby would be sufficiently resistant to
compressive closure while still remaining flexible, e.g.,
longitudinally and/or radially flexible.
[0144] The ACDs described herein also can be used for gastric
bypass procedures, general tissue bunching or bringing tissues
together, and on or in other vessels, organs, tissues, bones,
and/or other body tissues than those specifically described.
[0145] While several particular forms of the arterial closure
device and deployment tool have been illustrated and described, it
will be apparent that various modifications and combinations of the
inventions detailed in the text and drawings can be made without
departing from the spirit and scope of the inventions. For example,
references to materials of construction, methods of construction,
specific dimensions, shapes, utilities or applications are also not
intended to be limiting in any manner and other materials and
dimensions could be substituted and remain within the spirit and
scope of the inventions. Accordingly, it is not intended that the
inventions be limited, except as by the appended claims.
Accordingly, other embodiments are within the scope of the
following claims and figures.
* * * * *