U.S. patent application number 11/344868 was filed with the patent office on 2006-08-24 for integrated vascular device with puncture site closure component and sealant and methods of use.
Invention is credited to W. Martin Belef, Richard S. Ginn.
Application Number | 20060190037 11/344868 |
Document ID | / |
Family ID | 23898839 |
Filed Date | 2006-08-24 |
United States Patent
Application |
20060190037 |
Kind Code |
A1 |
Ginn; Richard S. ; et
al. |
August 24, 2006 |
Integrated vascular device with puncture site closure component and
sealant and methods of use
Abstract
Apparatus and methods are provided for use in sealing a vascular
puncture site. The invention comprises an integrated vascular
device having a sheath with a closure component and puncture
sealant. The closure component is disposed on and advanceable over
the exterior of the sheath and may comprise any of a variety of
apparatus suited for closing a vascular puncture. Once the closure
component has been actuated to close the puncture, sealant is
introduced to seal the puncture. The sheath and closure component
are then removed from the patient.
Inventors: |
Ginn; Richard S.; (San Jose,
CA) ; Belef; W. Martin; (San Jose, CA) |
Correspondence
Address: |
WORKMAN NYDEGGER
1000 EAGLE GATE TOWER,
60 EAST SOUTH TEMPLE
SALT LAKE CITY
UT
84111
US
|
Family ID: |
23898839 |
Appl. No.: |
11/344868 |
Filed: |
February 1, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10147774 |
May 17, 2002 |
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11344868 |
Feb 1, 2006 |
|
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09478179 |
Jan 5, 2000 |
6197042 |
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10147774 |
May 17, 2002 |
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Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 17/0057 20130101;
A61B 2017/00668 20130101; A61B 17/064 20130101; A61B 2017/00862
20130101; A61B 17/083 20130101; A61B 2017/00637 20130101; A61M
25/0662 20130101; A61B 2017/0641 20130101; A61B 17/00491 20130101;
A61B 17/10 20130101; A61B 17/128 20130101; A61B 2017/00663
20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A method of closing an opening in tissue, comprising: disposing
a sheath within a tissue tract, wherein a distal end of the sheath
is disposed within an opening formed in tissue; performing a
medical procedure through a lumen of the sheath; closing the
opening with a closure component, the closure component comprising
at least two sharpened tips for engagement with tissue adjacent the
opening, the sharpened tips having an expanded delivery
configuration and a retracted deployed configuration to close the
opening; and applying a sealing means to the opening to effect
closure of the opening.
2. The method according to claim 1, wherein the step of applying a
sealing means comprises applying a sealing means selected from a
group consisting of RF energy, thermal energy, electrical
induction, infrared light, ultrasonic vibration, microwave or laser
irradiation, clips, sutures, or adhesives.
3. The method according to claim 1, further comprising the step of
delivering a sealant to the opening.
4. The method according to claim 1, further comprising the step of
disposing a clip adjacent the opening to further seal the opening
closed.
5. The method according to claim 1, wherein the closing step
further comprises rotating the closure component after engaging the
sharpened tips with the tissue.
6. The method according to claim 1, wherein the sharpened tips are
associated with elastically deformed prongs.
7. The method according to claim 6, wherein the step of closing the
opening further comprises moving a member within the closure
component proximally to enable the elastically deformed needles to
resiliently contract.
8. A method of closing an opening in tissue, comprising: disposing
a sheath within a tissue tract, wherein a distal end of the sheath
is disposed within an opening formed in tissue; performing a
medical procedure through a lumen of the sheath; positioning a
closure component to close the opening, the closure component
comprising at least two sharpened tips for engagement with tissue
adjacent the opening, the sharpened tips having an expanded
delivery configuration and a retracted deployed configuration;
closing the opening formed in the tissue; and applying a sealing
means to the opening to effect closure of the opening.
9. The method according to claim 8, wherein positioning the closure
component comprises sliding the closure component along the sheath
until the at least two sharpened tips engage with tissue.
10. The method according to claim 8, wherein closing the opening
comprises moving a member within the closure component proximally
to move the at least two sharpened tips towards one another.
11. The method according to claim 8, wherein closing the opening
comprises rotating the closure component after engaging the at
least two sharpened tips with the tissue.
12. A method of closing an opening in tissue, comprising: disposing
a sheath within a tissue tract, the sheath comprising a proximal
end, a distal end disposable within an opening formed in tissue,
and a lumen extending from the proximal end toward the distal end;
performing a medical procedure through the lumen of the sheath;
positioning a closure component upon the tissue adjacent to the
opening, the closure component comprising at least two sharpened
tips for engagement with tissue, the sharpened tips having an
expanded delivery configuration and a retracted deployed
configuration; closing the opening formed in the tissue; and
applying a sealing means to the opening to effect closure of the
opening.
13. The method according to claim 12, wherein applying the sealing
means comprises: disposing a sealing device, which supports a clip,
through the lumen of the shaft; deploying the clip from the sealing
device to effect closure of the opening.
14. The method according to claim 13, wherein disposing the sealing
device comprises moving the sealing device through the lumen until
at least two sharpened tips of the clip contacts the tissue.
15. The method according to claim 13, further comprising delivering
a sealant to the opening.
16. The method according to claim 13, wherein the sealing device
comprises a first jaw and a second jaw pivotal relative to the
first jaw, the first jaw and the second jaw selectively retaining
the clip.
17. The method according to claim 15, wherein deploying the clip
comprises moving the second jaw relative to the first jaw to
release the clip.
18. The method according to claim 13, wherein closing the opening
comprises moving a member within the closure component proximally
to move the at least two sharpened tips towards one another.
19. The method according to claim 18, wherein the at least two
sharpened tips are associated with elastically deformed needles,
and wherein moving the member releases the elastically deformed
needles and moves the at least two sharpened tips towards one
another.
20. The method according to claim 13, wherein closing the opening
comprises rotating the closure component after engaging the at
least two sharpened tips with the tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 10/147,774, filed May 17, 2002, which is a
continuation-in-part of U.S. patent application Ser. No. 09/478,179
filed Jan. 5, 2000, now U.S. Pat. No. 6,197,042, the disclosures of
which are each incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] 1. The Field of the Invention
[0003] 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 an integrated vascular device comprising
a sheath having a puncture closure components and puncture
sealant.
[0004] 2. The Relevant Technology
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] To reduce the cost and complexity of percutaneous puncture
closure devices, such devices employing resilient or deformable
clips 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.
[0011] 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
and 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. 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.
[0012] The use of backbleed indication as a positioning technique
within a vascular puncture is known. For example, U.S. Pat. No.
4,317,445 to Robinson describes a flashback chamber for providing
visual indication of venous entry of a cannula. However, that
device does not discuss vascular wound closure. U.S. Pat. No.
5,676,689 to Kensey et al., which claims priority from the U.S.
Pat. No. 5,222,974 patent discussed above, uses a vessel location
device to simplify positioning of the biodegradable plug. The
vessel locator enables blood from the vessel to flow there through
so that the position of the vessel may be determined. However, the
Kensey system only proffers one closure device, and that device is
complex and raises concerns about biocompatibility. It also
requires the closure component to be positioned within the
puncture, thereby increasing the likelihood of dangerous
over-advancement of the plug into the vessel.
[0013] The percutaneous puncture closure devices described in the
foregoing patents generally have the drawback that they require
relatively complex mechanisms and require time consuming
manipulation to achieve hemostasis. It therefore would be desirable
to provide apparatus and methods suitable for vascular puncture
closure that overcome these disadvantages of previously known
devices.
[0014] It also would be desirable to provide apparatus and methods
that quickly and effectively achieve hemostasis.
[0015] It further would be desirable to provide apparatus and
methods wherein all foreign materials left in a patient's body are
bioabsorbable.
[0016] It still further would be desirable to provide vascular
puncture closure apparatus and methods that are safe, low cost, and
easy to use.
BRIEF SUMMARY OF THE INVENTION
[0017] 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.
[0018] It also is an object of this invention to provide apparatus
and methods suitable for vascular puncture closure that quickly and
effectively achieve hemostasis.
[0019] It further is an object of the present invention to provide
apparatus and methods wherein all foreign materials left in a
patient's body are bioabsorbable.
[0020] It still further is an object of the present invention to
provide vascular puncture closure apparatus and methods that are
safe, low cost, and easy to use.
[0021] These and other objects of the present invention are
accomplished by provided an integrated vascular device comprising a
sheath having a puncture closure component and puncture sealant.
The closure component is disposed on and advanceable over the
exterior of the sheath, which may, for example, comprise an
introducer sheath, a trocar, or a catheter. The closure component
may comprise any of a variety of apparatus suited to close a
vascular puncture. Once the closure component has been actuated to
close the puncture, sealant is introduced to the exterior surface
of the closed puncture, preferably through the sheath's interior
lumen, where the sealant seals the puncture closed. The sheath with
closure component is then removed from the patient.
[0022] In a preferred embodiment constructed in accordance with the
present invention, the closure component comprises a twist closure
device. The device pierces tissue surrounding the vascular puncture
and then is rotated to close the wound. In an alternative
embodiment, the closure component comprises needles and an elastic
segment surrounding the needles. The needles pierce the puncture
with the elastic segment expanded. The segment is then allowed to
resiliently contract to an unstressed configuration of smaller
diameter, thereby drawing the needles together and closing the
wound.
[0023] In a still further alternative embodiment, the needles, or
prongs, are elastically deformed to an expanded diameter, in which
they pierce the tissue adjacent to puncture. The needles then are
allowed to resiliently contract to an unstressed configuration of
smaller diameter, thereby closing the wound.
[0024] Sealant then may be introduced, preferably through the
interior lumen of the sheath, to seal the puncture closed. The
sealant may comprise any of a variety of sealants, per se known,
including adhesives, sutures, and clips, all of which are
preferably bioabsorbable. Alternatively, the closure component may
further comprise the sealant, wherein the closure component is left
in place within the vessel until hemostasis naturally occurs, or
wherein the closure component comprises a monopolar electrode or
opposed bipolar electrodes that cauterize the wound with RF
current. In addition to cauterization, RF energy generates heat
that beneficially causes shrinkage of the vascular tissue, thereby
assisting closure of the wound. Thermal energy from electrical
induction, infrared light, ultrasonic vibration, microwave or laser
irradiation, and other means may also be used to seal the
puncture.
[0025] Advantageously, the puncture closure component of the
present invention is inexpensively integrated into a sheath,
thereby minimizing mechanical complexity while providing quick,
safe, effective, and easy-to-use apparatus for achieving vascular
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
[0026] 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:
[0027] FIG. 1 is a side view of a preferred embodiment of an
integrated vascular device constructed in accordance with the
present invention;
[0028] FIG. 2 is a side-sectional view of a sealing device for use
with the vascular device of FIG. 1;
[0029] FIGS. 3A-3D are side views of the closure component of FIG.
1 in use at a vascular puncture site, shown in section, with the
sealing device of FIG. 2, illustrating a method of sealing the
puncture site;
[0030] FIGS. 4A-4D are top views of the vascular puncture site of
FIG. 3, corresponding to the side-sectional views of FIG. 3,
further illustrating the method of FIG. 3;
[0031] FIGS. 5A-5C are side-sectional views of an alternative
embodiment of an integrated vascular device of the present
invention in use at a vascular puncture site, illustrating a method
of sealing the puncture site;
[0032] FIGS. 6A-6E are side-sectional views of a further
alternative embodiment in use at a vascular puncture site,
illustrating a method of sealing the puncture site; and
[0033] FIGS. 7A and 7B are isometric views of a section of vessel
including and corresponding to the vascular puncture site of FIG.
6, further illustrating the method of FIG. 6.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0034] The integrated vascular 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, low cost, effective,
and easy-to-use solution to wound closure. Apparatus constructed in
accordance with the present invention provide vascular access 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.
[0035] Referring to FIG. 1, a first embodiment of apparatus of the
present invention is described. Vascular device 10 comprises sheath
12 coupled to hub 14, closure component 16, and closure actuator
18.
[0036] Sheath 12, which may, for example, comprise an introducer
sheath, a trocar, or a catheter, includes central lumen 13 through
which other devices may be introduced into the vasculature, for
example, to perform a diagnostic or interventional procedure such
as angiography, angioplasty, or stenting, or to seal a puncture
site.
[0037] Hub 14 is mounted on the proximal end of sheath 12 and
includes side port 20, arc lumens 22, and device port 24. Device
port 24 communicates with central lumen 13 of sheath 12, and has
self-sealing elastomeric membrane 25 disposed across it.
Self-sealing membrane 25, which may comprise, for example, latex or
a biocompatible synthetic rubber, permits interventional devices to
be introduced through device port 24, while preventing blood loss
through central lumen 13. Side port 20 of hub 14 is also in
communication with central lumen 13, and is connected to hemostatic
port 26 via biocompatible tubing 28.
[0038] In accordance with the principles of the present invention,
closure component 16 comprises lumen 30 that receives sheath 12.
Component 16 is slidably disposed on the exterior of sheath 12 and
is movable from a stowed position, adjacent hub 14, to a distal
deployment position, where tines 17 of component 16 are urged into
engagement with tissue surrounding a vascular puncture. Closure
component 16 comprises at least two sharpened tips, or tines 17.
Tines 17 preferably comprise backbleed ports 32. Closure component
16 is rotatable within arc-lumens 22 about the longitudinal axis of
sheath 12, so that, with tines 17 engaging tissue surrounding the
vascular puncture, component 16 closes the puncture.
[0039] Closure actuator 18 comprises plunger 34 and tubes 36, which
are configured to slidably pass through arc lumens 22 of hub 14.
The proximal ends of tubes 36 are coupled to backbleed bores 38 of
plunger 34. The distal ends of tubes 36 are mounted, either
permanently or detachably, in closure component 16, so that
movement of plunger 34 causes corresponding proximal or distal
movement of closure component 16. Likewise, rotation of plunger 34
causes corresponding rotation of tubes 36 within arc lumens 22,
which, in turn, rotates closure component 16 about the longitudinal
axis of sheath 12.
[0040] Plunger 34 further comprises device bore 40, coaxially
aligned with device port 24, and through which interventional
devices or puncture sealants may be passed. As described in detail
hereinafter, when plunger 34 is moved to its proximal-most
position, closure component 16 is disposed adjacent to hub 14 and
preferably provides adequate clearance for interventional devices
to be inserted through device port 24 and central lumen 13 into the
patient's vasculature. When moved to its distal-most position,
plunger 34 causes tubes 36 to urge closure component 16 distally.
Interventional devices or sealants then may be introduced through
device bore 40, device port 24, and central lumen 13 into the
vasculature.
[0041] Backbleed bores 38 of plunger 32 are in communication with
backbleed lumens (not shown) within tubes 36. The backbleed lumens
of tubes 36 are in communication with backbleed ports 32 of tines
17, thereby establishing a complete backbleed path through ports
32, the lumens (not shown) of tubes 36, and bores 38. When tines 17
of closure component 16 pierce a vessel wall surrounding a vascular
puncture, blood enters backbleed ports 32 and exits through
backbleed bores 38, providing visual confirmation to a surgeon that
tines 17 are positioned within the vessel wall. The backbleed path
thus enables the surgeon to determine when closure component 16 has
been sufficiently advanced to permit rotation of component 16 to
close the puncture, while reducing the risk that component 16 is
either short of the puncture site or is extended into the
vessel.
[0042] In conjunction with closure of the puncture site caused by
rotation of component 16, a puncture sealant may be introduced to
the puncture site to seal the site closed. The sealant may, for
example, comprise an adhesive, such as a bioglue, tissue sealant,
or clotting agent, delivered through hemostatic port 26,
biocompatible tubing 28, side port 20 and central lumen 13 of
introducer sheath 12 to the vascular puncture to further help seal
the vessel after puncture closure with closure component 16.
Alternatively, the adhesive may be delivered through device port 24
or through the backbleed path described above. Instead of
adhesives, the closure component may further comprise the sealant,
wherein the closure component is left in place within the vessel
until hemostasis naturally occurs. The sealant may also comprise
sutures delivered through central lumen 13. Additionally, the
sealant may comprise thermal energy application from, for example,
electrical induction, infrared light, ultrasonic vibration,
microwave or laser irradiation, and other means.
[0043] With reference to FIG. 2, an alternative puncture sealing
device in accordance with the present invention is described.
Sealing device 50 comprises delivery device 52 and clip 54.
Delivery device 52 comprises proximal end 56 attached to tube 58.
Tube 58 terminates at first jaw 60 at its distal end and further
comprises lumen 62 and pin 64. Pin 64 extends into lumen 62 from an
interior surface of tube 58 and is disposed perpendicular to the
longitudinal axis of tube 58.
[0044] Delivery device 52 further comprises second jaw 66 having
female connector 68 coupled to pin 64, so that second jaw 66 pivots
about pin 64. Second jaw 66 further comprises moment arm 70.
Tension spring 72 is coupled to moment arm 70 and to the interior
surface of tube 58 in a manner that biases second jaw 66 against
first jaw 60.
[0045] First jaw 60 and second jaw 66 preferably form channel 74
when biased against one another. Channel 74 is configured to
receive clip 54. The biasing force applied by tension spring 72
holds clip 54 within channel 74, so that the clip may be advanced
into tissue surrounding a vascular puncture that has had its edges
approximated by closure component 16 (FIG. 1).
[0046] Delivery device 52 still further comprises plunger 76
coupled to pushrod 78 having release arm 80. Pushrod 78 is received
within lumen 62 of tube 58, so that release arm 80 engages moment
arm 70.
[0047] Distal advancement of pushrod 78, via application of force
to plunger 76, causes release arm 80 to urge moment arm 70
distally. This motion overcomes the biasing force applied by
tension spring 72 and causes second jaw 66 to pivot about pin 64.
Second jaw 66 thus no longer contacts first jaw 60, and clip 54 is
released from channel 74. Tube 58, first jaw 60, second jaw 66, and
clip 54 of sealing device 50 preferably are sized for introduction
into a patient's vasculature through device bore 40, device port
24, and lumen 13 of vascular device 10.
[0048] Referring to FIGS. 3A-3D through 4A-4D, in conjunction with
FIGS. 1 and 2, a method of using vascular device 10 with sealing
device 50 is described. Sheath 12 is advanced through skin, fat,
and muscle tissue into vessel V, through the vessel wall tissue
surrounding vascular puncture P. With plunger 34 and tubes 36 of
actuator 18 in the proximal-most, fully retracted position, an
interventional procedure is performed by introducing one or more
interventional devices, e.g. angioplasty balloons, stent delivery
systems, atherectomy devices, etc., through device port 24 and
lumen 13 of 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 sheath 12 during the
interventional procedure.
[0049] Upon completion of the procedure, vascular device 10 may be
advantageously used to close vascular puncture P. At this point,
closure actuator 18 and closure component 16 are disposed in the
proximal-most position, with component 16 adjacent to hub 14.
Closure actuator 18 is advanced by urging plunger 34 in the distal
direction, thus causing tubes 36 to slide through arc lumens 22 of
hub 14 and advance closure component 16.
[0050] As seen in FIG. 3A, continued distal advancement of plunger
34 causes tines 17 at the distal end of closure component 16 to
pierce tissue surrounding puncture P, so that the backbleed ports
32 of tines 17 directly communicate with the puncture wound. Tine
punctures T in FIG. 4A represent the points at which tines 17 enter
vessel V. The presence of pressure in the vessel higher than
atmospheric pressure causes blood to pass through backbleed ports
32, through the backbleed lumens (not shown) of tubes 36, and exit
through the proximal ends of backbleed bores 38, thus confirming
that tines 17 have engaged tissue around the puncture site and
should not be advanced further.
[0051] In FIG. 3B, sheath 12 is removed from puncture P to
facilitate closure of the puncture. Closure actuator 18 is held
stationary while hub 14 is withdrawn proximally, thereby
withdrawing sheath 12 proximally from puncture P. The puncture
remains open, as seen in FIG. 4B. With sheath 12 no longer within
puncture P, closure actuator 18 is rotated within arc lumens 22 to
rotate closure component 16. Rotation of closure component 16
causes tines 17 to rotate and urge the puncture closed, as seen in
FIGS. 3C and 4C.
[0052] Upon closure of puncture P, a sealant is introduced to seal
the wound closed. The sealant may, for example, comprise an
adhesive, such as a bioglue, tissue sealant, or clotting agent, it
may comprise a suture, it may comprise thermal energy application,
or it may comprise leaving the closure component in place within
vessel V until hemostasis naturally occurs. Alternatively, the
sealing device may comprise a clip, as described hereinafter.
[0053] FIGS. 3D and 4D show apparatus 10 used in conjunction with
sealing device 50 of FIG. 2. With clip 54 disposed in channel 74 of
delivery device 52, the delivery device is delivered to vessel V
through device bore 40 of closure actuator 18, device port 24 of
hub 14, and central lumen 13 of sheath 12. Clip 54 punctures the
vessel at tissue surrounding closed puncture P, creating clip
punctures C and sealing the puncture. Pushrod 78 of delivery device
52 is then actuated to separate second jaw 66 from first jaw 60 to
release clip 54 from delivery device 52. Apparatus 10 and delivery
device 52 are removed from the patient to complete the procedure.
Clip 54 maintains closure until hemostasis occurs and is preferably
bioabsorbable so that no foreign materials are permanently
implanted in the patient's body. Additional clips may also be
implanted, as required.
[0054] With reference now to FIGS. 5A-5C, an alternative integrated
vascular device in accordance with the present invention is
described. Apparatus 100 comprises sheath 102 coupled to hub 104,
closure component 106, and closure actuator 108.
[0055] Like sheath 12, sheath 102 may, for example, comprise an
introducer sheath, a trocar, or a catheter, and includes central
lumen 103 through which other devices may be introduced into the
vasculature, for example, to perform a diagnostic or interventional
procedure such as angiography, angioplasty, or stenting, or to seal
a puncture site. Hub 104 comprises bore 110, which slidably
receives actuator 108, and device port 112, which is in
communication with central lumen 103 of sheath 102 and permits
introduction of interventional devices while preventing blood loss
through central lumen 103. Hub 104 further comprises side port
114.
[0056] Closure component 106 comprises outer housing 116 having
lumen 118 configured to slidably receive sheath 102, bore 120 for
slidably receiving inner housing 122, lumen 124 adapted to receive
closure actuator 108, and needles or prongs 126 with sharpened tips
128. Inner housing 122 has lumen 123 adapted to receive sheath 102
and channels 130 adapted to receive prongs 126. Component 106
comprises at least two prongs 126, and preferably comprises
four.
[0057] Closure actuator 108 comprises actuation tube 132 having
lumen 133, actuation rod 134 disposed within actuation tube 132,
first plunger 136 coupled to the proximal end of tube 132, and
second plunger 138 coupled to the proximal end of rod 134. The
distal end of tube 132 is affixed, either permanently or
detachably, in lumen 124 to outer housing 116 of closure component
106, while the distal end of rod 134 is coupled to inner housing
122.
[0058] To perform an interventional procedure through central lumen
103 of sheath 102, the sheath is advanced through skin, fat, and
muscle tissue into vessel V, through vascular puncture P, in
accordance with well-known techniques. With closure component 106
in the proximal-most, fully retracted position adjacent hub 104,
the 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
112 and lumen 103 of sheath 102, again in accordance with
well-known techniques. Side port 114 may be used to infuse fluids,
e.g., contrast agents or medications, into the vessel through
sheath 102 during the interventional procedure.
[0059] Upon completion of the procedure, apparatus 100
advantageously may be used to close the vessel. Closure component
106 is advanced distally by urging plungers 136 and 138 distally.
Inner housing 122 is only partially received within bore 120 of
outer housing 116 so that prongs 126 are elastically deformed and
received within channels 130. As shown in FIG. 5A, closure
component 106 is advanced until inner housing 122 abuts against the
vessel V, as may be determined, for example, with a backbleed
indicator (not shown).
[0060] In FIG. 5B, first plunger 136 is urged distally to distally
advance actuation tube 132 and outer housing 116, while second
plunger 138 and sheath 102 are held stationary. Advancement of
outer housing 116 advances sharpened tips 128 of prongs 126 into
tissue surrounding puncture P.
[0061] In FIG. 5C, sheath 102 and second plunger 138 are retracted
proximally to draw sheath 102 out of vessel V and to draw inner
housing 122 completely within bore 120 of outer housing 116.
Proximally retracting inner housing 122 via actuation rod 134 and
second plunger 138 removes prongs 126 of outer housing 116 from
channels 130 of the inner housing. The prongs resiliently contract
to a lower stress configuration, thereby drawing opposing sides of
puncture P together and closing the wound. A sealant, for example
clip 54 of FIG. 2, may then be introduced to the closed puncture to
seal the site closed, as discussed hereinabove. Alternatively, the
sealing device may comprise RF current, supplied by an RF generator
(not shown), applied across opposed tips 128, which act as bipolar
electrodes.
[0062] Referring to FIGS. 6A-6E, as well as FIGS. 7A and 7B, a
still further alternative embodiment of apparatus of the present
invention is described. FIG. 6 depict the closure component of an
integrated vascular device in use at vascular puncture P within
vessel V. Apparatus 150 comprises sheath 152 coupled to a hub (not
shown), closure component 154, and a closure actuator (not shown).
Various closure actuators for use with closure component 154 will
be apparent to those of skill in the art from the foregoing
embodiments.
[0063] Sheath 152 may, for example, comprise an introducer sheath,
a trocar, or a catheter, and includes central lumen 153 through
which other devices may be introduced into the vasculature, for
example, to perform a diagnostic or interventional procedure such
as angiography, angioplasty, or stenting, or to seal a puncture
site. Closure component 154 comprises spacer 156, needles 158, and
needle cover 160. Spacer 156 is coaxially and slidably disposed
about the exterior of sheath 152, and preferably has an annular
diameter of about 1 mm to ensure that needles 158 engage the tissue
surrounding puncture P rather than enter the puncture, so that the
needles are able to draw the wound closed, as described
hereinbelow. Needles 158 are disposed between spacer 156 and cover
160 during advancement to puncture P. Needles 158 comprise ledges
162, which act as positive stops to prevent excessive advancement
of the needles with respect to cover 160, which comprises
corresponding annular ledge 164. Cover 160 further comprises
elastic segment 166, configured to elastically deform needles 158.
Closure component 154 comprises at least two needles 158, and
preferably comprises four. Needles 158 may further comprise
retaining means (not shown), such as barbs or hooks, to assist in
gripping tissue.
[0064] As shown in FIG. 6A, sheath 152 may be advanced through
skin, fat, and muscle tissue into vessel V, through vascular
puncture P, in accordance with well-known techniques. With closure
component 154 in a proximal-most, fully retracted position adjacent
the hub, an interventional procedure is performed through central
lumen 153 of sheath 152 by introducing one or more interventional
devices through the lumen into the patient's vasculature. Closure
component 154 then is advanced via the closure actuator until it
abuts against vessel V, as may be determined, for example, with a
backbleed indicator, such as described for the foregoing
embodiments. Cover 160 protects needles 158 and prevents snagging
of tissue as closure component 154 is distally advanced down sheath
152 and through skin, fat, and muscle tissue. Spacer 156 retains
needles 158 in a position away from the edge of puncture P.
[0065] In FIG. 6B, needles 158 are distally advanced with respect
to needle cover 160 until ledge 162 abuts ledge 164. Needles 158
deflect elastic segment 166 of cover 160 outward and pierce tissue
surrounding puncture P. FIG. 7A depicts, in isometric view, the
segment of vessel V surrounding puncture P. With a needle
arrangement comprising four needles 158, the needles create needle
punctures N surrounding vascular puncture P. Sheath 152 and spacer
156 then are retracted proximally and removed from vessel V, as
shown in FIG. 6C. As depicted in FIGS. 6D and 7B, elastic segment
166 of needle cover 160 resiliently contracts, thereby drawing
needles 158 together and approximating the edges of the wound.
[0066] A sealant, such as a bioglue, tissue sealant, or clotting
agent, then may be introduced to the puncture site to seal the
wound closed. Alternatively, closure component 154 may be
maintained in position until hemostasis occurs naturally, or
sutures may be introduced through central lumen 153. In addition,
or in the alternative, RF energy may be applied across needles 158,
as described hereinabove with respect to FIG. 5, or a clip, such as
clip 54 of sealing device 50 of FIG. 2, may be applied. Thermal
energy from electrical induction, infrared light, ultrasonic
vibration, microwave or laser irradiation, and other means may also
be used to seal the puncture.
[0067] Illustratively, FIG. 6E depicts sealing device 170,
comprising adhesive 172, being delivered through central lumen 153
within delivery sheath 174. After sufficient time for adhesive 172
to set, apparatus 150 is removed from vessel V.
[0068] Although preferred illustrative embodiments of the present
invention are described hereinabove, it will be evident to one
skilled in the art that various changes and modifications may be
made without departing from the invention. 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.
* * * * *