U.S. patent application number 09/764813 was filed with the patent office on 2001-07-05 for vascular sheath with puncture site closure apparatus and methods of use.
This patent application is currently assigned to Medical Technology Group, Inc.. Invention is credited to Aldrich, William N., Ginn, Richard S..
Application Number | 20010007077 09/764813 |
Document ID | / |
Family ID | 23898839 |
Filed Date | 2001-07-05 |
United States Patent
Application |
20010007077 |
Kind Code |
A1 |
Ginn, Richard S. ; et
al. |
July 5, 2001 |
Vascular sheath with puncture site closure apparatus and methods of
use
Abstract
Apparatus and methods are provided for use in sealing a vascular
puncture site. The invention comprises an introducer sheath with an
integrated closure component. The closure component includes an
advanceable resilient spring clip with an expanded delivery
configuration in which opposing sides do not contact one another,
and an unstressed deployed configuration, in which opposing sides
close towards one another. The clip is advanced along the sheath
until it pierces opposing sides of a vessel wall at a puncture
site. The sheath then is withdrawn, thereby causing the clip to
resiliently return to its unstressed deployed configuration and
draw opposing sides of the puncture together to seal the wound.
Inventors: |
Ginn, Richard S.; (San Jose,
CA) ; Aldrich, William N.; (Los Altos Hills,
CA) |
Correspondence
Address: |
LYON & LYON LLP
SUITE 4700
633 WEST FIFTH STREET
LOS ANGELES
CA
90071-2066
US
|
Assignee: |
Medical Technology Group,
Inc.
3273 Kifer Road
Santa Clara
CA
95051
|
Family ID: |
23898839 |
Appl. No.: |
09/764813 |
Filed: |
January 16, 2001 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
09764813 |
Jan 16, 2001 |
|
|
|
09478179 |
Jan 5, 2000 |
|
|
|
6197042 |
|
|
|
|
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 2017/00862
20130101; A61B 2017/0641 20130101; A61B 17/128 20130101; A61B
17/0057 20130101; A61B 2017/00637 20130101; A61B 2017/00668
20130101; A61B 17/10 20130101; A61B 17/083 20130101; A61M 25/0662
20130101; A61B 17/064 20130101; A61B 17/00491 20130101; A61B
2017/00663 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. Apparatus for sealing a puncture in a vessel wall comprising: an
introducer sheath having proximal and distal regions and an
exterior surface; a housing coaxially and slidably disposed on the
exterior surface of the introducer sheath, the housing including a
portion defining a chamber; a clip resiliently expandable from an
unstressed, deployed configuration wherein opposing sides of the
clip are directed inwards towards one another, and an expanded,
delivery configuration, in which the clip is slidably accepted
within the chamber; and an actuator for deploying the clip from the
chamber into engagement with the vessel wall to close the
puncture.
2. The apparatus of claim 1, wherein the actuator advances the clip
from the proximal end of the sheath to the vessel wall.
3. The apparatus of claim 2, wherein the actuator comprises at
least one elongated member coupled to the housing.
4. The apparatus of claim 3, wherein the at least one elongated
member has a first position wherein the at least one elongated
member engages the housing, and a second position wherein the at
least one elongated member rotates the housing with respect to the
expander to decrease an interior length of the chamber.
5. The apparatus of claim 1, wherein the clip is fabricated from a
superelastic material.
6. The apparatus of claim 1, wherein the clip comprises a tubular
member comprising a plurality of elongated tissue-engaging
members.
7. The apparatus of claim 6 further comprising barbs attached to
the tissue-engaging members.
8. The apparatus of claim 6, wherein the tubular member further
comprises a plurality of elongated legs having proximal and distal
ends, a plurality of upper members connecting respective proximal
ends of the elongated legs, and a plurality of lower members
interconnecting respective alternating distal ends of the elongated
legs, wherein the plurality of tissue-engaging members project from
the plurality of lower members.
9. The apparatus of claim 1, wherein the clip is bioabsorbable.
10. The apparatus of claim 1 further comprising at least one
backbleed indicator port coupled to a proximal end of the
introducer sheath to indicate a position of the housing relative to
the puncture.
11. The apparatus of claim 10 wherein a tissue sealant may be
delivered to the vessel wall in a vicinity of the puncture.
12. The apparatus of claim 1 further comprising a side port for
introducing fluids into the introducer sheath.
13. A method of sealing a puncture in a vessel wall, the method
comprising: providing apparatus comprising an introducer sheath
having proximal and distal regions and a lumen extending
therebetween, a housing slidably and coaxially disposed on the
proximal region of the introducer sheath, a resilient clip disposed
within the housing in an expanded delivery configuration, and a
clip actuator; inserting the distal region of the introducer sheath
through a patient's skin into a vessel via the puncture; performing
an interventional or diagnostic procedure by advancing a device
through the lumen of the introducer sheath; upon completion of the
procedure, coupling the clip actuator to the housing; advancing the
clip and housing through the skin with the clip actuator until the
clip pierces the vessel wall on opposing sides of the puncture; and
withdrawing the introducer sheath, housing, and clip actuator from
the puncture so that the clip returns to an unstressed deployed
configuration and seals the puncture.
14. The method of claim 13 further comprising delivering a tissue
sealant to the vessel wall in a vicinity of the puncture.
15. The method of claim 13 wherein the housing further comprises
backbleed indicator ports coupled to the proximal region of the
introducer sheath, the method further comprising advancing the clip
and housing until blood from the puncture flows through the
backbleed indicator ports to the proximal region of the introducer
sheath.
16. The method of claim 13 wherein the introducer further comprises
a hub having a bore and the clip actuator further comprises an
elongated member, wherein coupling the clip actuator to the housing
further comprises inserting the elongated member through the bore
of the hub.
17. The method of claim 13 wherein the apparatus further comprises
an expander which expands the clip to the delivery configuration,
and advancing the clip and housing further comprises advancing the
housing relative to the expander to deploy the clip from within the
housing.
18. Apparatus for sealing a vascular puncture comprising: an
introducer sheath having proximal and distal regions, a lumen
extending therebetween, and an exterior surface; an expander having
an exterior surface, the expander slidably and coaxially disposed
on the exterior surface of the introducer sheath; a housing
coaxially disposed on and cammingly engaged with the expander, the
housing including a portion defining a chamber; a resilient clip
having an unstressed, deployed configuration, in which the clip
closes the puncture, and an expanded, delivery configuration, in
which the clip slidably passes over the exterior surface of the
expander; and an actuator operably coupled to the housing for
deploying the clip from the chamber.
19. The apparatus of claim 18, wherein the actuator is fixedly
coupled to the housing.
20. The apparatus of claim 18, wherein the clip is fabricated from
a superelastic material.
21. The apparatus of claim 18, wherein the clip comprises a tubular
member including a plurality of tissue-engaging members.
22. The apparatus of claim 18, wherein the clip is
bioabsorbable.
23. The apparatus of claim 18 further comprising at least on e
backbleed indicator port coupled to a proximal end of the
introducer sheath to indicate a position of the housing relative to
the puncture.
24. The apparatus of claim 18, wherein the actuator advances the
clip from the proximal end of the sheath to the puncture.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to apparatus and methods for
sealing an iatrogenic puncture in a vessel formed in conjunction
with a diagnostic or therapeutic treatment. More particularly, the
present invention provides apparatus comprising an introducer
sheath including a puncture site closure device comprising an
expandable clip with elastic memory.
BACKGROUND OF THE INVENTION
[0002] Catheterization and interventional procedures, such as
angioplasty and stenting, generally are performed by inserting a
hollow needle through a patient's skin and muscle tissue into the
vascular system. A guide wire then is passed through the needle
lumen into the patient's blood vessel. The needle is removed and an
introducer sheath is advanced over the guide wire into the vessel.
A catheter typically is passed through the lumen of the introducer
sheath and advanced over the guide wire into position for a medical
procedure. The introducer sheath therefore facilitates insertion of
various devices into the vessel while minimizing trauma to the
vessel wall and minimizing blood loss during a procedure.
[0003] Upon completion of the medical procedure, the catheter and
introducer sheath are removed, leaving a puncture site in the
vessel. Commonly, external pressure is applied until clotting and
wound sealing occurs. However, this procedure is time consuming and
expensive, requiring as much as an hour of a physician's or nurse's
time, is uncomfortable for the patient, and requires that the
patient be immobilized in the operating room, cathlab, or holding
area. Furthermore, a risk of hematoma exists from bleeding prior to
hemostasis.
[0004] Various apparatus have been developed for percutaneously
sealing a vascular puncture by occluding or suturing the puncture
site. For example, U.S. Pat. Nos. 5,192,302 and 5,222,974 to Kensey
et al., describe the use of a biodegradable plug delivered through
the introducer sheath into the puncture site. When deployed, the
plug seals the vessel and provides hemostasis. Such devices have
been slow to gain acceptance in the medical community, however, due
to difficulties encountered in positioning the plug within the
vessel. Moreover, the agents used to occlude the puncture site are
animal-derived, typically collagen-based. Thus, a risk of adverse
immunoresponse exists.
[0005] Another previously known technique comprises percutaneously
suturing the puncture site with specialized apparatus. Such
apparatus is described, for example, in U.S. Pat. No. 5,304,184 to
Hathaway et al. While percutaneous suturing devices may be
effective, a significant degree of skill may be required on the
part of the practitioner. Because such devices are mechanically
complex, they tend to be relatively expensive to manufacture.
[0006] Surgical staples and resilient clips for external skin wound
closure are well known in the art, Examples include U.S. Pat. No.
5,026,390 to Brown and U.S. Pat. No. 5,683,405 to Yacoubian et al,
which both describe resiliently deformable closure devices suitable
for manual external application.
[0007] To reduce the cost and complexity of percutaneous puncture
closure devices, such devices employing resilient clips or staples
have been developed. U.S. Pat. No. 5,478,354 to Tovey et al.
describes the use of resilient clips in conjunction with a trocar
to close abdominal puncture wounds. U.S. Pat. No. 5,810,846 to
Virnich et al. describes a specialized apparatus for closing a
vascular puncture site with a plastically deformable clip. The
apparatus preferably is advanced over a guide wire through a
cannula to the surface of the puncture site, where the staple-like
clips are delivered to close the wound.
[0008] U.S. Pat. No. 5,782,861 to Cragg et al. describes
specialized apparatus for closing a puncture site with a detachable
clip. The apparatus comprises a hollow shaft, having a distal end
formed with one or more opposed pairs of resilient grasping prongs,
that is advanced over a guide wire through a coaxial hollow tube to
a position at the distal end of the tube just proximal of the
puncture.
[0009] The grasping prongs are extended beyond the distal end of
the tube to grasp the vessel on opposing sides of the puncture. The
shaft then is partially retracted, causing the prongs to contract
within the tube, thereby sealing the puncture site. Both of the
devices described in the foregoing patents have the drawback that a
separate device must be deployed through the introducer sheath to
close the puncture site, thus prolonging the procedure. Moreover,
both devices require relatively complex apparatus and involve time
consuming manipulation to achieve hemostasis.
[0010] In view of the foregoing, it would be desirable to provide
apparatus and methods suitable for vascular puncture closure that
overcome the disadvantages of previously known devices.
[0011] It also would be desirable to provide apparatus and methods
for vascular puncture closure that quickly and effectively achieve
hemostasis.
[0012] It further would be desirable to provide vascular puncture
closure apparatus and methods that do not require the introduction
of additional apparatus at the completion of the catheterization
procedure to achieve closure.
[0013] It still further would be desirable to provide apparatus and
methods suitable for vascular puncture closure that do not
introduce animal-derived material into the bloodstream.
[0014] It would be desirable to provide vascular puncture closure
apparatus and methods that are safe, lower cost, and easy to
use.
SUMMARY OF THE INVENTION
[0015] In view of the foregoing, it is an object of the present
invention to provide vascular puncture closure apparatus and
methods that overcome disadvantages of previously known
devices.
[0016] It also is an object of this invention to provide apparatus
and methods suitable for vascular puncture closure that quickly and
effectively achieve hemostasis.
[0017] It is a further object of the present invention to provide
apparatus and methods for vascular puncture closure that do not
require the introduction of additional apparatus at the completion
of the catheterization procedure to achieve closure.
[0018] It is another object of this invention to provide vascular
puncture closure apparatus and methods that do not introduce
animal-derived material into the bloodstream.
[0019] It is yet another object of the present invention to provide
vascular puncture closure apparatus and methods that are safe,
lower cost, and easy to use.
[0020] These and other objects of the present invention are
accomplished by providing a vascular introducer sheath having an
integrated wound closure component. The closure component consists
of a resilient spring clip disposed on and advanceable over the
exterior of the introducer sheath in an expanded delivery
configuration until opposite sides of the clip pierce a vessel on
opposite sides of a puncture site. The introducer sheath is then
withdrawn, enabling the spring clip to contract to its unstressed
deployed configuration, thereby drawing opposite sides of the
puncture together and closing the wound. Means also are provided
for confirming when the spring clip has engaged the vessel wall,
thereby indicating to the surgeon that the clip may be deployed and
the introducer sheath may be withdrawn. Alternative embodiments of
the spring clip also are provided.
[0021] Advantageously, the closure component is inexpensively
integrated into a standard introducer sheath, thereby eliminating
the need for a separate closure device at the conclusion of a
catheterization procedure. The present invention provides a quick,
safe, effective and easy-to-use technique for wound closure that
overcomes drawbacks of previously known devices. Methods of using
the apparatus of the present invention also are provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The above and other objects and advantages of the present
invention will be apparent upon consideration of the following
detailed description, taken in conjunction with the accompanying
drawings, in which like reference characters refer to like parts
throughout, and in which:
[0023] FIG. 1 is a side view of a vascular device constructed in
accordance with the present invention;
[0024] FIG. 2 is a cross sectional view of the closure component of
the vascular device of FIG. 1;
[0025] FIGS. 3A-3D are side views of the resilient clip of the
present invention shown from different angles in an expanded
delivery configuration and in an unstressed deployed
configuration;
[0026] FIGS. 4A and 4B are isometric views of an alternative
embodiment of the resilient surgical clip, constructed in
accordance with the present invention and shown, respectively, in
an unstressed deployed configuration and in an expanded delivery
configuration; and
[0027] FIGS. 5A-5F are side-sectional views of a vascular puncture
site, illustrating a method of sealing the puncture site with the
integrated vascular device of FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0028] The integrated vascular introducer sheath with closure
component of the present invention overcomes disadvantages
associated with previously known methods and apparatus for sealing
a vascular puncture by providing a quick, simple, safe, lower cost,
effective, and easy-to-use solution to wound closure. Apparatus
constructed in accordance with the present invention provide
vascular introduction and wound closure in a single device,
eliminating the time and manipulation required to insert a separate
closure device at the completion of a procedure.
[0029] Referring to FIG. 1, vascular device 10 comprises introducer
sheath 12 coupled to hub 14, clip housing 16, and clip actuator
18.
[0030] Introducer sheath 12 comprises a material typically used for
vascular introducer sheaths, such as polyethylene or nylon, and
includes central lumen 13 through which other devices may be
introduced in the vasculature, for example, to perform a diagnostic
or interventional procedure such as angiography, angioplasty or
stenting.
[0031] Hub 14 is mounted to the proximal end of introducer sheath
12 and includes side port 20, arc-shaped lumens 22, backbleed
lumens 24, backbleed tubes 25, and device port 26. Device port 26
communicates with central lumen 13 of introducer sheath 12, and has
self-sealing elastomeric membrane 27 disposed across it.
Self-sealing membrane 27, which may comprise, e.g., latex or a
biocompatible synthetic rubber, permits interventional devices to
be introducer through device port 25 while preventing blood loss
through central lumen 13. Side port 20 of hub 14 is in
communication with central lumen 13, and is connected to hemostatic
port 34 via biocompatible tubing 36.
[0032] Clip housing 16 includes an annular-shaped chamber that
holds a elastically deformable clip. In accordance with the
principles of the present invention, clip housing is slidably
disposed on the exterior of introducer sheath 12 and is movable
from a stowed position, adjacent hub 14, to a distal clip
deployment position, where the spring clip is urged into engagement
with tissue surrounding vascular puncture.
[0033] Clip actuator 18 comprises plunger 28 and rods 30, which are
configured to slidably pass through arc-shaped lumens 22 of hub 14.
The distal ends of rods 30 are mounted in clip housing 16, so that
movement of plunger 28 causes corresponding proximal or distal
movement of clip housing 16. As described in detail hereinafter,
when plunger 28 is moved to its proximal-most position, clip
housing is disposed adjacent to hub 14 and provides adequate
clearance for interventional devices to be inserted device port 25
and central lumen 13 into the patient's vasculature. When moved to
its distal-most position, plunger 28 causes rods 30 to urge clip
housing 16 distally.
[0034] Referring now also to FIG. 2, the closure component of
vascular device 10 is described in greater detail. Clip housing 16
comprises bore 38 that slidably receives introducer sheath 12,
bores 40 in which rods 30 are mounted, and backbleed indicator
ports 42. Backbleed indicator ports 42 are coupled to backbleed
tubes 25 via lumens 44. Housing 16 further comprises threaded bore
46 with male thread 48 and proximal ledge 50, and clip bore 52 with
proximal ledge 54. Threaded bore 46 engages female thread 56 of
clip expander 58. Clip expander 58 is slidably disposed on
introducer sheath 12, and together with the portion of clip housing
16 surrounding the spring clip 62 forms annular chamber 60.
[0035] Spring clip 62 is stored in its expanded delivery
configuration in annular chamber 60 so that it slidably passes over
clip expander 58 until it abuts proximal ledge 54 of clip bore 52.
In a delivery configuration of vascular device 10, the length of
annular chamber 60, as measured from the distal end of clip
expander 58 to proximal ledge 54, extends within the distal end of
clip housing 16 for a sufficient distance to cover the length of
clip 62. In this manner, clip housing 16 prevents snagging spring
clip 62 from snagging on tissue during advancement of clip housing
16 to its deployed position, as described hereinbelow.
[0036] Rods 30 pass through arc-shaped lumens 22 of hub 14 and
mounted in bores 40 of clip housing 16. Distal advancement of rods
30 causes clip housing 16, expander 58, and spring clip 62 to
advance distally a corresponding distance relative to introducer
sheath 12. When plunger 28 is moved to its distal-most position,
rods 30 may be rotated within arc-shaped lumens 22 to rotate and
advance clip housing 16 relative to clip expander 58. This motion
causes clip housing 16 to advance distally along female thread 56
of clip expander 58 until the proximal end of the clip expander
contacts proximal ledge 50 of threaded bore 46. Further rotation of
rods 30 causes proximal ledge 54 to urge a tissue-engaging portion
of spring clip 62 distally off of clip expander 58. With clip
housing 16 positioned at a vascular puncture site P, rotation of
rods 30 causes the tissue-engaging portion, illustratively spikes,
to pierce the vessel wall, as seen in dotted profile in FIG. 2.
[0037] In alternative embodiments, plunger 28 and rods 30 may be
removably coupled to clip housing 16, to permit unobstructed access
to device port 26. In this embodiment, rods 30 may include teeth
that may be rotated to fixedly engage bores 40 in clip housing
16.
[0038] As discussed hereinabove, backbleed indicator ports 42 are
coupled to tubes 25 via blood lumens 44 that extend through clip
housing 16. Backbleed tubes 25 are slidably disposed through
backbleed lumens 24 of hub 14. When the distal end of clip housing
16 is advanced distally against the vessel wall at puncture P,
blood enters blood indicator ports 42 and exits tubes 25, providing
visual confirmation to the surgeon that the distal end of clip
housing 16 is positioned adjacent to the vessel wall. Backbleed
tubes 25 thus enable the surgeon to determine when clip housing 16
has been advanced sufficiently to permit clip deployment, while
reducing the risk that the clip is either deployed short of the
puncture site or extended into the vessel.
[0039] Still referring to FIG. 1, in conjunction with clip
deployment, a bioglue or tissue sealant may be delivered through
hemostatic port 34, tubing 36, port 20 and central lumen 13 of
introducer sheath 12 to vascular puncture P to further help seal
the vessel after deployment of clip 62. Alternatively, the bioglue
or tissue sealant may be delivered through the backbleed path
described above.
[0040] Referring now to FIGS. 3A-3D, an illustrative spring clip 62
constructed in accordance with the principles of the present
invention is described in greater detail. FIG. 3B is a side view of
the clip of FIG. 3A rotated 90 degrees, wherein clip 62 is in an
expanded delivery configuration. Clip 62 comprises an annular
device having upper members 70 joined to lower members 72 by legs
74 to form lumen 80. Outer spikes 76 and inner spikes 78 are
connected to lower members 72, and act as elongated tissue-engaging
members. Clip 62 is elastically expanded by advancing introducer
sheath 12 or clip expander 58 through lumen 80.
[0041] Upon removal of the introducer sheath, spring clip 62
resiliently returns to its unstressed deployed configuration,
illustrated in FIGS. 3C and 3D, where FIG. 3C corresponds to the
view of FIG. 3A and FIG. 3D corresponds to the view of FIG. 3B.
When removed from the exterior of introducer sheath 12, spring clip
62 resumes its deployed shape, in which the opposing sides of the
clip come together until lower members 72 contact one another, and
outer spikes 76 cross inner spikes 78. As depicted in FIG. 3A, clip
62 also may optionally comprise engagement means 77 to securely
engage the vessel being closed. Engagement means 77 may, for
example, comprise barbs or hooks.
[0042] Clip 62 is preferably fabricated from a superelastic
material, such as a nickel-titanium alloy, but may comprise any
material with sufficient resilience to elastically expand for
delivery over sheath 12 and fit within annular chamber 60 of clip
housing 16. Clip 62 also may be fabricated from a bioabsorbable
material or a combination bioabsorbable and elastically expandable
material.
[0043] FIGS. 4A and 4B illustrate an alternative embodiment of the
resilient spring clip of the present invention, wherein clip 90
comprises hoop 92 and opposing spikes 94. In FIG. 4A, clip 90 is
depicted in the unstressed, deployed configuration, in which
opposing spikes 94 contact one another, whereas in FIG. 4B clip 90
is depicted in the expanded, delivery configuration, in which
opposing spikes 94 are separated by gap 96. Clip 90 is elastically
expanded in a manner similar to clip 62 by advancement over
introducer sheath 12, and preferably also is fabricated from the
materials described hereinabove.
[0044] Referring now to FIGS. 5A-5F, in conjunction with FIGS. 1-3,
methods of using vascular device 10 are described. In FIG. 5A,
introducer sheath 12 has been advanced through skin, fat, and
muscle tissue T into vessel V, through vascular puncture P, which
is formed in accordance with well-known techniques. With plunger 28
and rods 30 in the proximal-most, fully retracted position, an
interventional procedure then is performed by introducing one or
more interventional devices, e.g. angioplasty balloons, stent
delivery systems, atherectomy devices, etc., through device port 26
and lumen 13 of introducer sheath 12 in accordance with well-known
techniques. Side port 20 may be used to infuse fluids, e.g.,
contrast agents or medications, into the vessel through introducer
sheath 12 during the interventional procedure.
[0045] Upon completion of the procedure, vascular device may be
advantageously used to close vascular puncture P. At this point,
clip actuator 18, housing 16, clip expander 58, and clip 62 are
disposed in the proximal-most position adjacent to hub 14, as
depicted in FIG. 5A.
[0046] As illustrated in FIG. 5B, clip actuator 18 then is advanced
by urging plunger 28 in the distal direction, thus causing rods 30
to slide through arc-shaped lumens 22 of hub 14 and advance clip
housing 16. Continued distal advancement of plunger 28 causes the
distal end of clip housing 16 to abut against the exterior of the
vessel, so that back bleed indicator ports 42 of clip housing 16
directly communicate with the puncture wound. The presence of
pressure in the vessel higher than atmospheric pressure causes
blood to pass through indicator ports 42, blood lumens 44, and exit
through the proximal ends of tubes 25, thus confirming that clip
housing 16 is positioned at the puncture site and should not be
advanced further.
[0047] In FIG. 5C, with clip housing 16 held immobile, clip
actuator 18 is rotated clockwise within arc-shaped lumens 22 so
that rods 30 rotate and advance clip housing 16 with respect to
clip expander 58 (see FIG. 2). Specifically, ledge 54 of housing 16
contacts the proximal end of clip 62 and drives the clip distally
so that its tissue-engaging members, spikes 76 and 78, contact and
pierce the wall of vessel V at points around the puncture site, as
discussed hereinabove with respect to FIG. 2.
[0048] Once the spikes have pierced the vessel wall, clip actuator
18 is rotated counterclockwise within arc-shaped lumens 22 to
retract clip housing 16, via threaded bore 46, along clip expander
58. The tissue-engaging members of clip 62 retain the clip within
the wall of vessel V while the housing retracts, as shown in FIG.
5D.
[0049] In FIG. 5E, with clip 62 engaged with the vessel wall, clip
housing 16 and clip expander 58 are withdrawn proximally by
proximally withdrawing actuator 18, thereby causing clip 62 to
slide off of clip expander 58. In FIG. 5E, spike 78 is embedded in
tissue not shown, because that tissue lies within the plane of the
cross section.
[0050] Vascular device 10 then is withdrawn from the vessel wall.
Once introducer sheath 12 is removed from lumen 80 of clip 62, the
clip rotates relative to the vessel wall, as shown in FIG. 5F, and
returns to its unstressed, deployed configuration, thus drawing
opposite sides of puncture P together to seal the puncture. At this
point, a suitable biocompatible bioglue or tissue sealant
optionally may be injected into the puncture tract, as discussed
hereinabove, through device port 26 or side port, to aid in sealing
vascular puncture P. Alternatively, the bioglue or tissue sealant
may be delivered through the backbleed path described above.
[0051] Although preferred illustrative embodiments of the present
invention are described above, it will be evident to one skilled in
the art that various changes and modifications may be made without
departing from the invention. For example, with minor
modifications, vascular device 10 may be configured to carry spring
clip 90 of FIGS. 4, or any of a variety of alternative expandable
resilient clips. It is intended in the appended claims to cover all
such changes and modifications that fall within the true spirit and
scope of the invention.
* * * * *