U.S. patent application number 11/626567 was filed with the patent office on 2008-07-24 for low-profile vascular closure systems and methods of using same.
This patent application is currently assigned to Medtronic Vascular, Inc.. Invention is credited to Kenneth A. Eliasen, Scott J. Epperly, Richard D. Lobello, Juan-Pablo Mas, Matthew F. Spurchise.
Application Number | 20080173691 11/626567 |
Document ID | / |
Family ID | 40602185 |
Filed Date | 2008-07-24 |
United States Patent
Application |
20080173691 |
Kind Code |
A1 |
Mas; Juan-Pablo ; et
al. |
July 24, 2008 |
Low-Profile Vascular Closure Systems and Methods of Using Same
Abstract
A method for closing an arteriotomy includes providing a guiding
system and a closure system. The guiding system is mounted over a
dilator, and advanced along a guidewire through the arteriotomy and
into the blood vessel lumen. The guiding system includes two
stabilization wire guides. A retention foot is disposed at a distal
portion of each stabilization wire guide, the foot being deployable
into contact against an inner surface of the vessel wall. The
guidewire and dilator are withdrawn from the patient, leaving the
stabilization wire guides in place. The closure system carries a
stapler and is advanced along the stabilization wire guides to an
extraluminal position. The stapler is then activated to close the
arteriotomy. The retention feet are undeployed and the guiding and
closure systems are withdrawn from the body, leaving a staple to
hold the arteriotomy closed.
Inventors: |
Mas; Juan-Pablo;
(Somerville, MA) ; Spurchise; Matthew F.;
(Peabody, MA) ; Lobello; Richard D.; (Johnston,
RI) ; Eliasen; Kenneth A.; (Wrentham, MA) ;
Epperly; Scott J.; (East Bridgewater, MA) |
Correspondence
Address: |
MEDTRONIC VASCULAR, INC.;IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA
CA
95403
US
|
Assignee: |
Medtronic Vascular, Inc.
Santa Rosa
CA
|
Family ID: |
40602185 |
Appl. No.: |
11/626567 |
Filed: |
January 24, 2007 |
Current U.S.
Class: |
227/175.1 |
Current CPC
Class: |
A61B 17/0218 20130101;
A61B 17/0686 20130101; A61B 2017/00637 20130101; A61B 2017/00668
20130101; A61B 2090/08021 20160201; A61B 2090/0801 20160201; A61B
17/0684 20130101; A61B 17/0644 20130101; A61B 17/07292 20130101;
A61B 2090/037 20160201; A61B 17/083 20130101; A61B 17/0057
20130101; A61B 2017/22038 20130101; A61B 17/10 20130101 |
Class at
Publication: |
227/175.1 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A method for closing a wall opening of a vessel of a body, the
method comprising the steps of: providing a guiding system
comprising at least two elongate stabilization wire guides and a
retention foot disposed at a distal portion of each stabilization
wire guide, each retention foot being selectively expandable
laterally from the respective stabilization wire guide in at least
one direction, the guiding system including a deployed
configuration wherein the retention feet are expanded, and an
undeployed configuration wherein the retention feet are unexpanded;
providing a closure system including an elongate center tube having
an elongate stapler slidably disposed there within, the center tube
being coupled to at least two opposing side tubes for riding along
the stabilization wire guides, respectively; delivering the guiding
system through the wall opening into the vessel in the undeployed
configuration; transforming the guiding system into the deployed
configuration such that the retention feet are expanded within the
vessel; advancing the closure system along the guiding system to a
position proximal to the wall opening; and activating the stapler
to close the opening.
2. The method of claim 1 further comprising, after transforming the
guiding system into the deployed configuration, positioning the
guiding system such that the expanded retention feet contact an
Inner surface of the vessel wall.
3. The method of claim 1 wherein activating the stapler comprises;
implanting a staple across the opening in the wall of the vessel;
and releasing the staple from the stapler.
4. The method of claim 1 further comprising, after activating the
stapler to close the opening, transforming the guiding system into
the undeployed configuration and withdrawing the guiding system and
elongate center tube from the body.
5. The method of claim 1 further comprising inserting a guidewire
through the wall opening and into a lumen of the vessel before
delivering the guiding system through the wall opening, and wherein
delivering the guiding system through the wall opening further
comprises advancing a dilator with the guiding system mounted
thereon along the guidewire, through the opening and into the
lumen.
6. The method of claim 5 further comprising withdrawing the
guidewire and the dilator from the body before advancing the
closure system along the guiding system.
7. The method of claim 5 further comprising removing a procedural
sheath from the body before advancing the dilator and the guiding
system along the guidewire.
8. The method of claim 1, wherein the side tubes are coupled
adjacent a distal portion of the center tube and wherein a length
of each side tube is substantially shorter than a length of the
center tube.
9. The method of claim 1, wherein the stapler comprises; an
elongate hollow shaft and an elongate driver slidably disposed
therein; a pair of opposing actuation tips disposed at a distal end
of the shaft and defining a staple chamber there between; an anvil
disposed within the staple chamber and affixed to one of the
actuation tips; and a staple at least partially disposed within the
staple chamber.
10. The method of claim 9, wherein the staple comprises: a pair of
opposing staple legs, each leg including a tip, an expansion ramp
extending toward the opposite staple leg, and an expansion bend
disposed at a proximal end of the leg; and a closure bend coupling
the expansion bends.
11. The method of claim 10, wherein each staple leg further
comprises a staple tissue stop.
12. The method of claim 10, wherein activating the stapler
comprises: advancing the driver between the actuation tips such
that the driver moves the staple, wherein the staple expansion
ramps ride along the anvil, thereby causing the expansion bends to
open and the staple tips to spread apart from each other; further
advancing the driver such that staple the expansion ramps clear the
anvil and the closure bend abuts the anvil; and further advancing
the driver such that the driver opens the closure bend, thereby
causing the staple tips to move toward each other to close the
staple.
13. The method of claim 9, wherein the staple comprises: a pair of
opposing staple legs, each leg including a tip and an expansion
ramp; and a bend coupling the legs; wherein the staple is made from
an elastic material and is pre-formed in a closed configuration
wherein the staple tips are touching or adjacent or crossing each
other.
14. The method of claim 13, wherein each staple leg further
comprises a staple tissue stop.
15. The method of claim 13, wherein activating the stapler
comprises; advancing the driver between the actuation tips, thereby
pushing the staple distally such that the staple expansion ramps
slide along the anvil, thereby causing the staple tips to spread
apart relative to each other; and further advancing the driver to
push the staple further distally such that the staple expansion
ramps clear the anvil and the elastic property of the staple causes
the staple tips to close toward each other.
16. The method of claim 1, wherein a frangible cap is disposed over
a distal opening of the center tube, and wherein the frangible cap
is pierced, fractured or torn open (luring the step of activating
the stapler.
17. The method of claim 1, wherein the center tube includes a
distal portion that is tapered or pinched to cover the stapler
until the closure system is advanced to the position proximal to
the lumen opening, and wherein the tapered or pinched distal
portion is spread apart during the step of activating the stapler.
Description
FIELD OF THE INVENTION
[0001] The present disclosure relates to system and method for
closing an opening in a vessel wall after a medical procedure, and
in particular, to a system and method for closing a puncture
arteriotomy after an intracranial procedure such as
catheterization.
BACKGROUND OF THE INVENTION
[0002] Catheters/catheterization procedures for diagnosis or
treatment of cardiovascular and/or peripheral vascular diseases are
well known, and typically involve the Seidinger technique to make
insertions through layers of tissue and through a wall of the
femoral artery. After a diagnostic or interventional
catheterization, the arteriotomy puncture formed by the catheter or
introducer sheath must be closed. The puncture opening in the
artery typically ranges from 5 French (0.0655 inch, 1.67 mm) such
as for a diagnostic angiography procedure to as large as 30 French
(0.393 inch, 10.00 mm) for an interventional procedure such as
implanting an inferior vena cava (IVC) filter. Traditionally,
intense pressure has been applied to the puncture site for at least
30-45 minutes after removal of the catheter. Patients who have had
a femoral artery puncture are then required to remain at bed rest,
essentially motionless and often with a heavy sandbag placed on
their upper legs, for several hours to ensure that the bleeding has
stopped. Other approaches include the use of a thrombotic or
collagen plug or slurry, and/or other suturing methodologies for
sealing the puncture. Also known are systems and methods for blind
delivery, viz., without direct visualization, of a staple or clip
to gather and hold together sides of the arteriotomy. However,
these closure systems typically deliver, or perform the closure
modality via a sheath, which holds the tissue track open.
Therefore, there is a need for a low-profile closure system.
BRIEF SUMMARY OF THE INVENTION
[0003] A method for closing an arteriotomy in a wall of a vessel of
a body after an intra-luminal procedure is disclosed. The terms
"distal" and "proximal " are used in the specification with respect
to a position or direction relative to the treating clinician.
"Distal" or "distally" are a position distant from or in a
direction away from the clinician. "Proximal" and "proximally" are
a position near or in a direction toward the clinician. The method
may be practiced without a sheath in place in the tissue track. A
guidewire from the intra-luminal procedure remains in the vessel,
or is replaced with another guidewire. A procedural sheath, if
used, is removed from the patient. A dilator and a guiding system
are advanced together along the guidewire into the body tissue,
through the arteriotomy and are into the vessel lumen. The guiding
system includes at least two stabilization wire guides, each
stabilization wire guide having a deployable retention foot,
disposed at a distal, portion thereof. The guiding system is
deployed within the vessel lumen such that the retention feet can
be pulled back against an inner surface of the vessel wall. The
guidewire and dilator are withdrawn from the lumen and the body
tissue, leaving only the guiding system in place. A closure system
is advanced along the guiding system to a position proximal to the
arteriotomy. The closure system includes a center tube housing a
stapler, the center tube having at least two side tubes for riding
along the stabilization wire guides. The stapler is then activated
to close the arteriotomy and the guiding system and closure system
are withdrawn from the lumen and the body.
[0004] An embodiment of the stapler includes an elongate hollow
shaft having at its distal end a pair of opposing actuation tips
that define a staple chamber there between. An anvil extends into
the staple chamber from one of the actuation tips to retain and
deform a staple. An elongate driver is slidably disposed in the
hollow shaft. A staple Includes a pair of opposing legs proximally
coupled by a bend and having an expansion ramp extending from each
leg toward the other leg. The staple may be opened and/or closed by
plastic or elastic deformation. When the closure system, is
disposed adjacent to the arteriotomy, an operator mechanism moves
the driver longitudinally relative to stapler shaft such that the
driver advances the staple between the actuation tips. The staple
expansion ramps ride and spread apart along the anvil, thereby
opening the staple. As the operator continues to push the driver
longitudinally, the staple expansion ramps clear the anvil,
permitting the staple to close. In an embodiment of the stapler,
the driver closes the staple by deforming the staple bend against
the anvil. In another embodiment of the stapler, the staple is
elastic-ally self-closing. A staple release mechanism is actuated
to spread the actuation tips apart, creating a gap through which
the staple is released from the anvil.
[0005] In an embodiment of the closure system, a distal portion of
the center tube is pinched such that it separates the staple tips
from the tissue track during delivery to the arteriotomy site. When
the staple is deployed, the staple spreads the pinched portion
apart.
[0006] In another embodiment of the closure system, a frangible cap
is disposed over the distal opening of the center lube. The
frangible cap separates the staple tips from the tissue track
during delivery to the arteriotomy site. When the staple Is
deployed, the staple perforates or fractures the frangible cap.
Optionally, a portion of the frangible cap tears away from the
center tube to form a pledget that is retained against the
arteriotomy by the staple.
BRIEF DESCRIPTION OF DRAWINGS
[0007] The foregoing and other features and advantages of the
present disclosure will be apparent from the following description
of the disclosure as illustrated in the accompanying drawings. The
accompanying drawings, which are incorporated herein and form a
part of the specification, further serve to explain the principles
of the disclosure and to enable a person, skilled in the pertinent
art to make and use the disclosure. The drawings are not to
scale.
[0008] FIG. 1 is a cross-sectional view of body tissue including a
vessel with a procedural device inserted in the vessel.
[0009] FIG. 2 is cross-sectional view of body tissue including a
vessel with a guidewire inserted in the vessel.
[0010] FIG. 3 is cross-sectional view of body tissue including a
vessel with a procedural sheath being removed from the tissue.
[0011] FIG. 4 is a cross-sectional view of an embodiment of a
dilator and retention system being inserted into body tissue.
[0012] FIG. 5 is a cross-sectional view of the dilator and
retention system of FIG. 4 being inserted into a vessel through an
arteriotomy.
[0013] FIG. 6 is a cross-sectional view of the dilator and
retention system of FIG. 4 with stabilization wire guides released
from the dilator.
[0014] FIG. 7 is a cross-sectional view of retention feet of the
stabilization wire guides of FIG. 6 deployed within a vessel and
the guidewire being removed from the vessel and body tissue.
[0015] FIG. 8 is a cross-sectional, view of the retention feet of
FIG. 7 deployed and the dilator being removed from the vessel and
body tissue.
[0016] FIG. 9 is a cross-sectional view of an embodiment of a
closure system as it enters the body tissue.
[0017] FIG. 10 is a cross-sectional view of the closure system of
FIG. 9 as it reaches a location just outside of the vessel,
adjacent the arteriotomy.
[0018] FIG. 11 Is a perspective view of the closure system of FIG.
9 with expansion tips extended beyond a distal opening of a center
tube.
[0019] FIG. 12 is a perspective view of the closure system of FIG.
9 as a staple is being deployed.
[0020] FIG. 13 is a perspective view of the closure system of FIG.
9 with the staple deployed to close the arteriotomy.
[0021] FIG. 14 is a perspective view of the closure system of FIG.
9 with the staple deployed and the center tube and stabilization
wire guides being removed from the body tissue.
[0022] FIG. 15 is a perspective cut-away view of an embodiment of a
stapler of the present disclosure.
[0023] FIG. 16 is a perspective cut-away view of the stapler of
FIG. 15 with the staple being deployed.
[0024] FIG. 17 is a perspective cut-away view of the stapler of
FIG. 15 with the staple closed after deployment.
[0025] FIG. 18 is a plan view of an embodiment of a staple of the
present disclosure.
[0026] FIG. 19 is a perspective view of the staple of FIG. 18.
[0027] FIG. 20 is a cut-away perspective view of another embodiment
of a stapler of the present disclosure.
[0028] FIG. 21 is a cut-away side view of the stapler of FIG. 20
with the staple being deployed.
[0029] FIG. 22 is a cut-away side view of the stapler of FIG. 20
with the staple closed, but not released.
[0030] FIG. 23 is a perspective view of an embodiment of an
expansion tip of the stapler of FIG. 20.
[0031] FIG. 24 is an end view of an embodiment of a pair of
expansion tips of the stapler of FIG. 20.
[0032] FIG. 25 is a perspective view of a center tube with a
pinched distal portion of the present disclosure.
[0033] FIG. 26 is a perspective view of the center tube of FIG, 25
during deployment of a stapler.
[0034] FIG. 27 is a perspective view of a center tube with a
frangible cap of the present disclosure.
[0035] FIG. 28 is a perspective view of the center tube of FIG. 27
during deployment of a stapler.
[0036] FIG. 29 is a perspective view of another embodiment of the
center tube of FIG. 27 with a pledget formed from a frangible cap
during deployment of a staple.
[0037] FIG. 30 is a perspective view of the closure system of FIG.
44 with the staple and pledget deployed and the center tube and
stabilization wire guides being removed from the body tissue.
[0038] FIG. 31 is a longitudinal cross-sectional view of a top view
of an embodiment of a release mechanism for releasing a staple from
a stapler of the present disclosure.
[0039] FIG. 32 is a longitudinal cross-sectional view of a top view
of the embodiment of FIG. 31, with the actuation tips spread
apart.
[0040] FIG. 33 is a longitudinal cross-sectional view of a top view
of another embodiment of a release mechanism for releasing a staple
from a stapler of the present disclosure.
[0041] FIG. 34 is a longitudinal cross-sectional view of a top view
of the embodiment of FIG. 29 with the actuation tips spread
apart.
[0042] FIG. 35 is a cut-away side view of a stapler with another
embodiment of a release mechanism for releasing a staple from a
stapler of the present disclosure.
[0043] FIG. 36 is a cut-away side view of the embodiment of FIG. 35
with the staple deployed, but not released from the stapler.
[0044] FIG. 37 is a cut-away perspective view of a portion of the
embodiment of FIG. 35.
[0045] FIG. 38 is longitudinal cross-sectional view of a top view
of the embodiment of FIG. 33 with the actuation tips spread
apart.
[0046] FIG. 39 is a perspective, view of an actuation tip of
another stapler In accordance with the disclosure.
[0047] FIG. 40 is a top view of a stapler incorporating the
actuation tip of FIG. 39 with the staple deployed, but not released
from the staple chamber.
[0048] FIG. 41 is a top view of the stapler of FIG. 40, after the
staple has been pushed forward to spread apart the actuation
tips.
[0049] FIG. 42 is a cut-away side view of a stapler with another
embodiment of a release mechanism for releasing a staple from a
stapler of the present disclosure.
[0050] FIG. 43 is a perspective view of an expansion tip of the
stapler of FIG. 42.
[0051] FIG. 44 is a cut-away side view of the stapler of FIG. 42
with the staple closed, but not released from the stapler.
[0052] FIG. 45 is a transverse cross-section view along line 45-45
of FIG. 44 with the actuation tip that, was cut away from FIGS. 42
and 44.
[0053] FIG. 46 is an alternative embodiment of the stapler of FIGS.
42-44, shown in a transverse cross-section view along line 46-46 of
FIG. 44 with the actuation tip that was cut away from FIGS. 42 and
44.
[0054] FIG. 47 is an outline of a method of using a vascular
closure system in accordance with the disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0055] Low Profile Guiding System
[0056] Specific embodiments of the present disclosure are now
described with reference to the FIGS., where like reference numbers
indicate identical or functionally similar elements. The present
disclosure is directed to a device and method for closing an
arteriotomy after a procedure in which a vessel was punctured to
gain access to the vessel lumen. FIGS. 1-10 show cross-sectional
views of body tissue 100 with a vessel 102 disposed therein. FIG. 1
shows a procedural device 108, such as a balloon catheter, disposed
partially within a lumen 104 of vessel 102. The distal end of
procedural device 108 is shown riding along a guidewire 110.
Procedural device 108 passes through a procedural sheath 106, which
maintains access to lumen 104 through a tissue track 101 in tissue
100 and arteriotomy 132 in the wall of vessel 102.
[0057] As the intra-luminal procedure, such as balloon angioplasty,
is completed, procedural device IDS is removed from vessel 102 and
tissue track 101 via procedural sheath 106, as shown in FIG. 2.
Guidewire 110 remains in place partially disposed within lumen 104
of vessel 102. As shown in FIG. 3, procedural sheath 106 is removed
from lumen 104, arteriotomy 132, and tissue track 101, leaving
guidewire 110 in place. Although tissue track 101 and arteriotomy
132 are shown in FIG. 3 as being maintained in an open state, in
practice, tissue track 101 and arteriotomy 132 will tend to at
least partially close around guidewire 110 when procedural sheath
106 is removed.
[0058] A vascular closure system, of the disclosure is used to
close arteriotomy 132, as follows. As shown in FIG. 4, a dilator
112 is guided along guidewire 110 into tissue track 101. Provided
with dilator 112 is a pair of stabilization wire guides 114.
Stabilization wire guides 114 ride along an outside surface of
dilator 112. Distal portions of stabilization wire guides 114 are
inserted into respective openings 116 in dilator 112 so that
stabilization wire guides 114 advance with dilator 112 into tissue
track 101. As shown in FIG. 5, dilator 112 and stabilization wire
guides 114 are advanced farther along guidewire 110 into lumen 104.
As dilator 112 is advanced into tissue track 101 and arteriotomy
132, dilator 112 opens tissue track 101 and arteriotomy 132.
[0059] As shown in FIG. 6, dilator 112 and stabilization wire
guides 114 are advanced far enough into lumen 104 of vessel 102 to
ensure that retention feet 118 are intraluminal prior to their
deployment. Numerous methods are known to those of skill in the art
to measure of accurately indicate the intraluminal position of
portions of a vascular closure device. In one known device,
intraluminal position of the device may be indicated by blood
entering the device through an inlet port positioned within the
vessel lumen, the blood flowing through a passageway in the device,
and the blood finally emitting from the device as a visible
"flashback" out of an exit port external to the patient. In an
alternative known type of position indicator, the device may have
an enlarged physical stop for abutting against the external wall of
the blood vessel to provide a tactile indication of the position of
the device with respect to the vessel wall.
[0060] Dilator 112 is advanced farther into lumen 104 of vessel 102
while stabilization wire guides 114 are restricted from movement.
This relative movement between dilator 112 and stabilization wire
guides 114 causes the distal portions of stabilization wire guides
114 to be exposed or released from openings 116 in dilator 112.
Stabilization wire guides 114 are manipulated or deployed to form
retention feet 118 in the distal portions thereof. Retention feet
118 may be formed in various ways as would be known to those of
ordinary skill in the art for example, the ways described in FIGS.
49-57 of U.S. Pat. No. 6,767,356 to Kanner et. al., the entire
disclosure of which is Incorporated herein by reference. Retention
feet 118 are pulled back against an Inner wall 120 of vessel 102,
thus providing temporary anchoring for stabilization wire guides
114, and also providing an indication, of the location, or depth of
inner wall 120 relative to other components of the vascular closure
system. For convenience of illustration, FIGS. 5-10 show a pair of
stabilization wire guides 114 aligned along the axis of vessel 102.
In actual use however, such a pair of stabilization wire guides 114
will typically be aligned transverse to the axis of vessel 102 and
positioned at the ends of the slit that naturally forms generally
perpendicular to the length, of the vessel when arteriotomy 132 is
formed in the wall of vessel 102, as described in the
above-mentioned Kanner '356 patent. Such transverse alignment of
stabilization wire guides 114 within arteriotomy 132 is especially
typical when stabilization wire guides 114 are spread apart by
closure system 122, as described below.
[0061] Referring to FIGS. 7 and 8, guidewire 110 and dilator 112
are removed from lumen 104, arteriotomy 132 and tissue track 101,
leaving only stabilization wire guides 114 extending through tissue
track 101 and arteriotomy 132 into lumen 104. Stabilization wire
guides 114 provide guidance for insertion of a closure system.
Referring to FIGS. 9 and 10, a closure system 122 is slidably
mounted onto stabilization wire guides 114 so that a distal portion
of closure system 122 can ride along stabilization wire guides 114
to a location within tissue track 101 spaced proximally from vessel
102. Closure system 122 includes an elongate stapler 128 carried
slidably within a center tube 124. Two or more relatively short
side tubes 126 are coupled parallel to the distal portion of center
tube 124 on opposing sides thereof. In an embodiment, center tube
124 may be 30 cm long and side tubes may be 2 cm long. Center tube
124 and side tubes 126 will separate stabilization wire guides 114
when closure system 122 is advanced there along. Separating
stabilization wire guides 114 applies tension along the long axis
of slit-shaped arteriotoray 132 such that tissue along both sides
of arteriotorriy 132 tends to come together for engagement by a
closure system, as described in the above-mentioned Kanner '356
patent.
[0062] FIG. 11 shows a side view of an embodiment of the present
disclosure. Vessel 102 is shown in longitudinal cross-section and
tissue 100 has been excluded for convenience of illustration. With
retention feet 118 deployed within lumen 104 of vessel 102, closure
system 122 is advanced toward arteriotomy 132 until the distal end
of closure system 122 is stopped extraluminally at a preset
distance from retention feet 118. The distance between the distal
end of closure system 122 and retention feet 118 may be preset in a
mechanism (not shown) coupled to the proximal ends of stabilization
wire guides 114 and center tube 124. After confirming the
apposition of retention feet 118 against, inner wall 120 of vessel
102, as shown in FIG. 11, stapler 128 may be advanced distally
within center tube 124 to expose a pair of actuation tips 129 and a
staple 130 held there between.
[0063] As shown in FIG. 12, two staple tips 139 of staple 130 are
expanded laterally and are extended distally from between actuation
tips 129 to pierce vessel tissue on either side of arteriotomy 132.
Note that, whereas side tubes 126 and stabilization wire guides 114
are described as being disposed on "sides" of stapler 128, then
"lateral" expansion of staple tips 139 means the tips expand toward
the top and bottom of stapler 128. It will be understood by one of
skill in the art that top, bottom and side are terms used only to
assist the reader in understanding the relative positions of the
components of the disclosure. Staple tips 139 are then closed to
gather or pucker the engaged tissue, thus closing arteriotomy 132.
Staple 130 is released from stapler 128 to remain embedded in
vessel 102. Described further below are several embodiments of the
disclosure that are suitable for releasing a staple from a stapler.
Stabilization wire guides 114 and closure system 122, except for
staple 130, are then removed from the body, as shown in FIG. 14.
Actuation tips 129 and staple 130 may be conventional as would be
known to one of ordinary skill in the art, such as the actuating
tip portion of a stapler and the staple shown in FIGS. 67-71 of the
above-mentioned Kanner '356 patent.
[0064] First Stapler Embodiment
[0065] FIGS. 15-19 show an embodiment of a stapler 228 of the
present disclosure. In particular, FIG. 15 is a cut-away
perspective view of stapler 228. FIG. 47 outlines a method 1000 of
using staplers in accordance with the disclosure, including stapler
228. Stapler 228 includes an elongate hollow shaft 227. At the
distal end of hollow shaft 227 is a pair of flat-sided, opposing
actuation tips 229 (only one tip 229a is shown in FIGS. 15-17), The
flat sides of actuation tips 229 face each other and are spaced
apart to provide a passageway for slidably receiving a flat distal
portion of an elongate driver 240, and to provide an open-sided
staple chamber for holding at least a proximal portion of a staple
230. The open sides of the staple chamber are oriented toward the
top and bottom of stapler 228. For example, see staple chamber 345
in FIG. 24. The distal end of driver 240 has a pair of tip edges
242 arranged to form an axially symmetrical pointed tip for
abutment against a proximal end of staple 230. An anvil 250 for
deforming or deflecting staple 230 Is fixed within the staple
chamber. Single anvil 250 may be dimensioned to substantially span
the staple chamber, as illustrated in FIG. 46, and may be
integrally formed with or attached to actuation tip 229a, without
being affixed to opposite actuation tip 229b. Alternatively, anvil
250 may be formed by two mating anvil halves, each anvil half being
integral with or attached to actuation tip 229a or 229b,
respectively. Driver 240 extends proximally within hollow shaft 227
to a handle (not shown) wherein a mechanism may be manually
operated to move driver 240 within hollow shaft 227, as will be
understood by one of ordinary skill in the art of medical stapling
devices. In an embodiment, driver 240 and hollow shaft 227 may each
be about 30 cm in length. Staple 230 includes two legs respectively
having proximally-located expansion bends 236a and 236b connected
by a closure bend 237. The two legs of staple 230 respectively have
staple expansion ramps 234a and 234b, optional staple tissue stops
238a and 238b, and staple tips 239a and 239b, See step 1010 in FIG.
47.
[0066] In practice, the distal portion of stapler 228 is positioned
at a preset distance from an arteriotomy, as shown with respect to
stapler 128 in FIG. 11. Sec also step 1020 in FIG. 47. Driver tip
edges 242a and 242b abut expansion bends 236a and 236b at the
proximal end of staple 230. Staple, tips 239a and 239b extend from
the distal end of hollow shaft 227, even prior to the initiation of
deployment of staple 230 from stapler 228. Driver 240 is advanced
distally within hollow shaft 227 such that driver tip edges 242a
and 242b push staple 230 distally in the staple chamber formed
between actuation tips 229 such that staple expansion ramps 234a
and 234b ride along, and are forced apart, by anvil 250. The
separation of expansion ramps 234a and 234b causes the legs of
staple 230 to separate and extend laterally through the open sides,
i.e. top and bottom of the chamber along the distal portion of
hollow shaft 227. As the legs of staple 230 are spread apart,
expansion bends 236a and 236b are forced open, and staple tips 239a
and 239b separate from each other, as shown in FIG. 16. See also
step 1030 in FIG. 47. The deformation of expansion bends 236a and
236b as they are opened may exceed the elastic limits of the staple
material such that at least some plastic deformation may occur.
Simultaneously, or closely coordinated with the spreading of the
staple legs, staple 230 is advanced distally such that staple tips
239a and 239b pierce vessel 102 to engage vessel tissue on either
side of arteriotomy 132. See step 1040 in FIG. 47. Stabilization
wire guides 114 aid in centering, or stabilizing closure system 122
over arteriotomy 132, as shown in FIGS. 11 and 12. The expanded
distance between tips 239a and 239b more than spans arteriotomy
132, as shown with respect to staple 130 in FIG. 12. As described
in the above-mentioned Kanner '356 patent, staple tissue stops 238a
and 238b help prevent tips 239a and 239b respectively from fully
penetrating the wall of vessel 102 and entering lumen 104.
[0067] As driver 240 continues to be moved distally in hollow shaft
227, staple closure bend 237 abuts anvil 250, and staple expansion
ramps 234a and 234b clear anvil 250, permitting at least some
elastic recovery of staple expansion bends 236a and 236b. See step
1050 in FIG. 47. Driver tip edges 242a and 242b force closure bend
237 against anvil 250, thereby deforming closure bend 237 into a
more open angle. The deformation of closure bend 237 may exceed the
elastic limits of the staple material such that at least some
plastic deformation may occur. Opening closure bend 237 causes the
legs of staple 230 to pivot in opposite directions around the apex
of closure head 237 such that staple tips 239a and 239b move toward
each other, as shown in FIG. 17. As staple tips 239a and 239b are
forced together, the vessel tissue between them is gathered or
puckered, thereby closing arteriotomy 132. When staple 230 closes,
staple tips 239a and 239b may approach, or touch, or even cross
over each other as shown in FIGS. 13, 14 and 17, depending upon the
amount of tissue between the tips.
[0068] First Staple Release Mechanism
[0069] As staple tips 239a and 239b close toward each other, the
proximal portion of staple 230 must be released from stapler 228.
Otherwise, as shown In FIG. 17, the proximal portion of staple 230
would be trapped by anvil 250. There are several ways for staple
230 to be released from stapler 228. FIGS. 31 and 32 are top
sectional views of stapler 228, with staple 230 being omitted for
clarity. Driver 240 may include a distal wedge 244, or
distally-facing wedges 244a and 244b disposed proximally from
driver distal edge 242. Wedges 244a and 244b extend laterally
outward from side surfaces 246a and 246b of driver 240 in the
direction of actuation tips 229a and 229b, respectively. Further,
actuation tips 229a and 229b include proximally-facing ramps 270a
and 270b, respectively, disposed proximally from anvils 250a and
250b. As described above, driver 240 is moved distally within
hollow shaft 227 such that closure bend 237 is opened to force
staple tips 239a and 238b together. In a simultaneous movement,
wedges 244a and 244b push against and slide along ramps 270a and
270b, respectively, thereby causing actuation tips 229a and 229b to
spread apart from each other, as shown in FIG. 32. With actuation
tips 229a and 229b spread apart from each other, a gap 272 is
formed between anvil 250a of actuation tip 229a and anvil 250b of
actuation tip 229b, thereby releasing staple 230 from the staple
chamber of stapler 228. See step 1060 in FIG. 47. Staple 230 is
thus permitted to remain in place, closing the arteriotomy as
stapler 228, including hollow shaft 227, actuation tips 229a and
229b and driver 240, is removed from the body. With this
embodiment, it is important to have close dimensional tolerances
between anvil 250 and ramps 270a and 270b, and between driver
distal edge 242 and wedges 244a and 244b to ensure coordination
between staple deployment and release.
[0070] Second Staple Release Mechanism
[0071] FIGS. 33 and 34 are top sectional views of another stapler
228', with staple 230 being omitted for clarity. In the embodiment
shown in FIGS. 33 and 34, driver 240' includes proximally-facing
wedges 244a' and 244b' disposed proximally from driver distal edge
242', and actuation tips 229a' and 229b' include distally-facing
ramps 270a' and 270b', respectively, disposed proximally from
anvils 250a and 250b. FIG. 33 shows stapler 228' after staple 230
has been deployed, but not released. In order to release the staple
from anvils 250a', 250b', driver 240' is moved proximally such that
wedges 244a' and 244b' engage ramps 270a' and 270b', respectively.
Ramps 270a' and 270b' ride up wedges 244a' and 244b', thereby
forcing actuation tips 229a' and 229b' apart from each other and
releasing the staple, as shown in FIG. 34. This embodiment is less
sensitive to dimensional tolerances than the embodiment shown in
FIGS. 31 and 32 because staple 230 is fully deployed before driver
240' is moved proximally to release staple 230.
[0072] Third Staple Release Mechanism
[0073] In another embodiment of a stapler 228'' shown in FIGS,
35-38, release mechanisms 280a and 280b are provided coupled to
each side of driver 240''. FIGS. 35 and 36 are side sectional views
of stapler 228''. Release mechanisms 280a and 280b each includes a
base 282a and 282b, a pair of arms 284a/b and 285a/b, and hooks
286a/b and 287a/b extending laterally outward from arms 284a/b,
285a/b, respectively. Actuation tips 229a'' and 229b'' (only
actuation tip 229a'' is shown in FIGS. 35-37) include notches
288a/b and 289a/b having ramps 290a/b and 291a/b. FIG. 35 shows
stapler 228'' with staple 230 in the pre-deployment configuration
as stapler 228'' is being delivered to the arteriotomy site. Arms
284a/b and 285a/b of release mechanisms 280a/b are resiliently
compressed toward each other by sidewalls 292a/b and 293a/b of
actuation tips 229a'' and 229b''. As driver 240'' is moved distally
within hollow shaft 227'' to push staple 230 against anvil 250a/b
hooks 286a/b and 287a/b arrive at notches 288a/b and 289a/b.
Sidewalls 292a/b and 293a/b no longer compress arms 284a/b and
285a/b as hooks 286a/b and 287a/b resiliently extend into notches
288a/b and 289a/b, respectively, as shown in FIG. 36. After staple
230 has been deployed to close the arteriotomy, driver 240'' is
moved proximally, thereby also moving release mechanisms 280a and
280b proximally, as shown in FIG. 37. As release mechanisms 280a
and 280b are moved proximally, hooks 286a/b and 287a/b ride up
ramps 290a/b and 291a/b. This motion causes actuation tips 229a''
and 229b'' to spread apart, thereby providing a gap 272 between
anvils 250a and 250b through which staple 230 may pass, as shown in
the top sectional view of stapler 228'' shown in FIG. 38. Note
that, as described above, staplers 228, 228' and 228'' may include
a single anvil 250 extending from one actuation tip toward the
other actuation tip instead of a pair of anvils 250a and 250b.
Similar to stapler 228' above, stapler 228'' is less sensitive to
dimensional tolerances because staple 230 is fully deployed before
driver 240'' is moved proximally to release staple 230.
[0074] Staple Materials
[0075] Staple 230 may comprise a biocompatible metal such as
nitinol (TiNi), stainless steel, tantalum, or titanium. Magnesium
or an alloy thereof may also be used to make staple 230, and such
materials also have the potential advantage of being bioabsorbable.
Staple 230 may also be formed from various filled or unfilled rigid
or semi-rigid polymers such as liquid crystal polymer (LCF),
polyamide, polycarbonate, poly-etheretherketone (PEEK),
polysulfone, polyvinylidene fluoride (PVDP), and may include
bioabsorbable or biodegradable polymeric materials such as
polycaprolactone, poly(glycolide) (PGA), poly(L-lactide) (PLLA) and
poly(D,L-lactide) (PLA). In an example of a method of making a
staple embodiment of the disclosure, staple 230 may formed of a
rigid thermoplastic in an injection mold. Staple 230 may be opened
by elastic and/or plastic deformation of expansion bends 236a and
236b and may be closed by elastic and/or plastic deformation of
closure bend 237. Combined elastic and plastic deformation refers
to a staple that has had its shape changed to exceed the elastic
region of its material properties, so the staple will only tend to
return part way to its previous shape.
[0076] Second Stapler Embodiment
[0077] In another embodiment, FIGS. 20-24 show an embodiment of a
stapler 328 of the present disclosure. In particular, FIG. 20 is a
cut-away perspective view of stapler 328. Stapler 328 Includes an
elongate hollow shaft 327 having, at its distal end, a pair of flat
opposing actuation tips 329 (only one tip 329a is shown In FIGS.
20-23) spaced apart to provide an open-sided chamber for holding a
staple 330. An elongate driver 340 is slidably disposed within
hollow shaft 327 and has a flat distal portion slidingly disposed
within the chamber. The distal end of driver 340 may be shaped,
e.g. concave, for abutment against a proximal bend of staple 330.
Anvil 350 for retaining and deflecting staple 330 may extend
substantially across the staple chamber and may be integral with or
attached to actuation tip 329a, without being affixed to opposite
actuation tip 329b. Alternatively, anvil 350 may be formed by two
mating anvil halves 350a and 350b, each anvil half being integral
with or attached to actuation tip 329a or 329b, respectively. Only
one anvil 350a is shown in FIGS. 20-23. Driver 340 extends
proximally within the hollow shaft to a handle (not shown) wherein
a mechanism may move the driver 340 relative to the hollow shaft
and actuation tips 329, as described above with respect to stapler
228.
[0078] Stapler 328 includes a staple 330 made according to a
material and a process such that it tends to elastically return to
a closed shape, as will be described with respect to FIGS. 20-22.
Staple 330 may be made of nitinol or other suitable elastic or
pseudoelastic shape memory alloy (SMA) that may be heat set in a
relaxed or neutral configuration such as the closed configuration
shown in FIGS. 20 and 22. Staple 330 is carried within stapler 328
and staple 330 may be heat set in a pre-formed or relaxed
configuration with staple tips 339a and 339b crossed over each
other, or barely touching each other, or spread slightly apart as
shown in FIG. 20. Staple tips 339a and 339b extend from the distal
end of hollow shaft 327, even prior to the initiation of deployment
of staple 330 from stapler 328. Staple 330 includes two legs
connected by a proximal bend. The legs respectively have staple
expansion ramps 334a and 334b, optional staple tissue stops 338a
and 338b, and staple tips 339a and 339b.
[0079] When stapler 328 is in the proper position with respect to
vessel 102, driver 340 is advanced distally within hollow shaft 327
such that the driver distal end pushes staple 330 distally in the
staple chamber between expansion tips 329, and staple expansion
ramps 334a/334b ride along, and are forced apart by anvil 350, as
shown in FIG. 21. The separation of expansion ramps 334a and 334b
causes the legs of staple 330 to separate and extend laterally from
the open sides of the staple chamber in the distal end of hollow
shaft 327. In a simultaneous action, staple tips 339a and 339b are
spread apart, the proximal staple bend is opened up, and staple 330
is advanced distally such that staple tips 339a and 339b pierce the
vessel wall (not shown) to engage vessel tissue on either side of
arteriotomy 132 (not shown). Referring to FIG. 22, as driver 340
continues to push staple 330 distally, expansion ramps 334a and
334b clear anvil 350, and the elastic or shape memory property of
the proximal bend of staple 330 causes staple tips 339a and 339b to
close toward each other. As staple tips 339a and 339b draw
together, the vessel tissue between them is gathered or puckered,
thereby closing the arteriotomy. When staple 330 closes, staple
tips 339a and 339b may again approach, or touch, or even cross over
each other, depending upon the pre-formed staple configuration and
the amount of tissue gathered between the tips.
[0080] The hollow shaft of stapler 328 and expansion tips 329a and
329b may be made of metal or stiff plastic suitable for insertion
into the human body, such as stainless steel, nitinol, high density
polyethylene, polyamide, or polyethylene block amide copolymer.
FIG. 23 shows a perspective view of actuation tip 329a, including
anvil 350 and side rails 360a and 361a, which terminate proximally
of the distal ends of expansion tips 329a and 329b. Side rails 360a
and 361a abut side rails 360b and 361b of expansion tip 329b, as
shown in FIG. 24, thus forming passageway 362 there between for
slidably receiving the flat distal portion of driver 340. Distally
of passageway 362, the flat surfaces of actuation tips 229 form
open-sided staple chamber 345, which contains anvil 350. In an
alternative embodiment, only one of the expansion tips includes the
side rails and the side rails abut against the flat surface of the
other expansion tip. In such an embodiment, the side rails may be
thicker than in an embodiment with side rails on each expansion tip
in order to create the appropriately-sized passageway 362 and
staple chamber 345. Although this description of the expansion tips
has referred to expansion tips 329a and 329b, it would be
understood that it applies equally to expansion tips 229.
[0081] Fourth Staple Release Mechanism
[0082] Similar to the description above with respect to staple 230
and FIGS. 15-19, staple 330 must clear anvils 350a/b in order to be
released from stapler 328. Such release can be accomplished by the
mechanisms and methods described above with respect to FIGS, 31-45.
In particular, anvils 350a and 350b may include proximally-facing
ramps 352a and 352b, as shown in FIGS. 20-22 and 39-44. After
expansion ramps 334a and 334b clear anvils 350a/b, and the elastic
or shape memory property of staple 330 causes staple tips 339a and
339b to close toward each other, as shown in FIG. 22. To release
staple 330 from stapler 328, driver 340 may be held in place
longitudinally as proximally-directed force is applied to hollow
shaft 327. Thus, driver 340 holds staple 330 against the
proximally-facing surfaces of anvils 350a and 350b, and holds
staple tips 339a and 339b in the vessel wall about the arteriotomy.
In this way, actions taken to release staple 330 from stapler 328
do not pull proximally on staple 330 once it is engaged with, the
tissue of the vessel wall. However, because the proximally-facing
surfaces of anvils 350a and 350b are ramps 352a and 352b,
respectively, proximal movement, of hollow shaft 327 forces ramps
352a and 352b to separate around the proximal bend of staple 330,
thereby causing actuation tips 329a and 329b to spread apart,
creating a gap 372 between anvils 350a and 350b, as shown in FIG.
41. As hollow shaft 327 continues to be moved proximally, anvils
350a/b clear staple 330, which is thereby released from stapler
328. Thus, stapler 328 releases deployed staple 330 by forcing
actuation, tips 329a and 329b to spread apart by engaging ramps
352a and 352b with staple 330 itself. Hollow shaft 327 and driver
340 can then be removed from the body.
[0083] Third Stapler Embodiment
[0084] Another embodiment of a stapler 428 is shown in FIGS. 42-45.
As shown, stapler 428 includes a staple 430 that is similar or
identical to staple 330 described above and is made of nitinol or
other suitable elastic or pseudoelastic shape memory alloy (SMA).
However, staple 430 of the present embodiment can also be similar
in shape and material properties to staple 230 shown and described
with respect to FIGS. 15-19.
[0085] Stapler 428 further includes actuation tips 429a/b. Only
actuation tip 429a is shown in FIGS. 42-44 for ease of viewing,
however, it would be understood by one of ordinary skill in the art
that actuation tip 429b is a mirror image of actuation tip 429a, as
shown in FIG. 43. Actuation tip 429a includes anvil 450a similar to
anvil 350a described with respect to FIGS. 20-24. Actuation tip
429a further includes first and second laterally opposed side ramps
454a and 456a disposed abutting the distal end of anvil 450a. Side
ramps 454a and 456a may be formed integrally with anvil 450a.
Stapler 428 further includes an elongate driver 440 and a staple
430, similar or identical to driver 340 and staple 330 described
above with respect to FIGS 20-24. Staple 430 includes staple
expansion ramps 434a and 434b.
[0086] In use, when stapler 428 is located in the proper position
relative to vessel 102, driver 440 is advanced within hollow shaft
424 such that the driver distal end pushes staple 430 distally in
the staple chamber between expansion tips 429a/b such that staple
expansion ramps 434a and 434b ride along, and are forced apart by
anvil 450a/b, as shown In FIG. 42. The separation of expansion
ramps 434a and 434b causes the legs of staple 430 to separate and
extend laterally from the open sides of the staple chamber in the
distal, end of hollow shaft 424. In a simultaneous action, staple
tips 439a and 439b are spread apart and staple 430 is advanced
distally such that staple tips 439a and 439b pierce the vessel wall
to engage vessel tissue on either side of arteriotomy 132. Note
that the forces that act to spread apart staple tips 439a and 439b
do not act orthogonally to simultaneously spread apart actuation
tips 429a and 429b. As driver 440 continues to push staple 430
distally, expansion ramps 434a and 434b clear anvil 450a/b, and
staple tips 439a and 439b close toward each other to gather or
pucker the engaged tissue, thus closing arteriotomy 132.
[0087] Staple 430 may be released from stapler 428 simultaneously
with or subsequently to deployment of staple 430 to close
arteriotomy 132. Driver 440 may be held in place longitudinally as
proximally-directed force is applied to hollow shaft 424 to release
staple 430. Thus, driver 440 holds staple 430 in the closed
configuration about the arteriotomy. That is, actions taken to
release staple 430 from stapler 428 do not pull proximally on
staple 430 once it is engaged with the tissue of the vessel wall.
As can be seen in FIGS. 42 and 44, when staple tips 439a and 439b
close toward each other, the tips of expansion ramps 434a and 434b
will also close toward each other and engage first side ramp 454a
and second side ramp 456a, respectively. The closing force of
staple 430 will wedge expansion ramp 434a between first side ramps
454a/b, and will simultaneously wedge expansion ramp 434b between
second side ramps 456a/b. Such wedging action will force actuation
tips 429a/b apart.
[0088] With actuation tips 429a and 429b spread apart from each
other, a gap is formed between anvil 450a of actuation tip 429a and
anvil 450b of actuation tip 429b. Hollow shaft 424 may then
continue to be moved proximally over driver 440, such that the gap
formed between anvils 450a/b clears staple 430, which is thereby
released from stapler 428. Thus, stapler 428 releases deployed
staple 430 by forcing actuation tips 429a and 429b to spread apart
by the closing force of staple 430 acting against side ramps 454a/b
and 456a/b. Hollow shaft 424 and driver 440 can then be removed
from the body. The closing force of staple 430 may be an inherent
elastic, resilient or shape memory property similar to that of
staple 330. Alternatively, the closing force of staple 430 may be
the result of moving driver 440 within hollow shaft 424 to
plastically deform staple 430 into a closed configuration, as
described above with respect to staple 230 shown in FIGS. 15-19.
Note that, as described above, stapler 428 may include a single
anvil extending from one actuation tip toward the other actuation
tip instead of a pair of anvils 450a and 450b.
[0089] Center Tube with Staple Protection
[0090] In the embodiments described above, closure system 122 may
be advanced along stabilization wire guides 114 through tissue
track 101 without a sheath placed in tissue track 101. Further, as
described above, any one of staplers 128, 228, 328, or 428 may be
slidably disposed within center tube 124 and may be advanced
through tissue track 101 together with center tube 124. Tips of
staples 130, 230, 330, and 430 extend distally from the respective
staplers, even prior to initiating deployment of the staples. Thus,
while closure system 122 is being advanced to the arteriotomy site,
it may be desirable to protect staple 130, 230, 330, or 430 against
possible damage from tissue track 101, or conversely, it may be
desirable to protect tissue track 101 against possible injury from
staple 130, 230, 330, or 430.
[0091] FIGS. 25 and 26 show an embodiment of a center tube 424
having at its distal end at least two opposing longitudinal slots
aligned with the side openings in the staple chamber of staplers
128, 228, 328, or 428, as described above. Center tube 424 further
includes a pair of opposing corners 427 defined where each slot
meets the distal opening of center tube 424. During staple
deployment wherein center tube 424 is advanced close to vessel 102,
the legs of staples 130, 230, 330, or 430 can expand laterally from
staplers 128, 228, 328, or 428 into the distal slots In center tube
424. In an alternative embodiment shown In FIGS. 11 and 12, the
center tube lacks distal slots such that staplers 128, 228, 328, or
428 must be advanced until staples 130, 230, 330, or 430 held in
the staple chamber are outside of the center tube before staple
deployment is initiated. In this embodiment, the center tube must
be spaced away from vessel 102 a sufficient distance such that,
during deployment, the stapler can be advanced to the point where a
staple can expand laterally without binding on the center tube.
[0092] To prevent contact between staple tips and tissue track 101,
as discussed above, center tube 424 is provided with an inwardly
tapered or pinched distal portion 425, which at least partially
covers or guards the staple tips. In the embodiment shown, pinched
distal portion 425 brings together corners 427 in center tube 424.
As in embodiments described above, center tube 424 is advanced
along stabilization wire guides 414 via side tubes 426. Pinched
distal portion 425 protects staple 430 from damage while being
advanced through tissue track 101, or protects tissue track 101
from injury by staple 430 passing there through. When center tube
424 is advanced to a position outside of the vessel, expansion tips
429a and 429b are advanced distally, opening pinched distal portion
425 and spreading the distal ends of the distal slots in center
tube 424, as shown in FIG. 26. Staple 430 is then opened and closed
around the arteriotomy as described in the embodiments above.
[0093] Alternatively, staple 430 may be deployed without advancing
the distal end of the stapler beyond the distal end of center tube
424. In this case, the opposing legs of staple 430 are permitted to
expand transversely from the open sides of the staple chamber and
to spread through the center tube slots, which are aligned with the
open sides of the staple chamber.
[0094] In another embodiment, the staple may be protected using a
frangible cap 574, as shown in FIGS, 27 and 28. Frangible cap 574
is fixed to and covers a distal portion of a center tube 524, and
includes a planar portion 576 extending across a distal opening of
center tube 524. Frangible cap 574 may be a biocompatible polymeric
membrane or a biocompatible metallic foil, and may include
perforations, grooves or other disruptions that define tear lines
within the cap. Frangible cap 574 may comprise one or more polymers
such as polyurethane, polyester or polystyrene. More resilient
polymers for making frangible cap 574 may comprise natural or
synthetic rubber such as butadiene/acrylonitrile copolymers,
copolyesters, ethylene vinylacetate (EVA) polymers,
ethylene/acrylic copolymers, ethylene/propylene copolymers,
fluorosilicone, latex, polyalkylacrylate polymers, polybutadiene,
polybutylene, polyethylene, polyisobutylene, polyisoprene,
polyurethane, silicone, styrenebutadiene copolymers,
styrene-ethylene/butylene-styrene, thermoset elastomer,
thermoplastic elastomer and combinations of the above. Polymeric
frangible cap 574 may be formed by various methods including
casting, compression molding, liquid injection molding, reaction
injection molding (RIM), resin transfer molding (RTM), and
thermoplastic injection molding. Polymeric frangible cap 574 may be
molded of soft foam, solid elastic material, or a combination
thereof.
[0095] Frangible cap 574 separates staple 530 from tissue track
while center tube 524 is advanced through a tissue track along
stabilization wire guides 514 via side tubes 526. Once center tube
524 has been advanced to a position outside of the vessel 102, a
stapler 528 carrying staple 530 is advanced distally through center
tube 524 such that the staple tips and/or the distal end of stapler
528 penetrate or fracture frangible cap 574, as shown in FIGS. 28
and 44. In the embodiment shown in FIG. 28, as stapler 528 exits
the distal end of center tube 524, at least planar portion 576 of
frangible cap 574 tears into a configuration having one or more
deflectable sections 577 such as flaps that swing, stretch, or
otherwise move aside, while frangible cap 574 remains integral and
fixed to center tube 524. Staple 530 is then opened, engaged and
closed around the arteriotomy as described In the embodiments
above.
[0096] In an alternative embodiment of the disclosure shown in
FIGS. 29 and 30, as stapler 528 exits the distal end of center tube
524, frangible cap 574' tears into a configuration wherein a
generally planar pledget 578 separates from the remainder of
frangible cap 574', which stays fixed to center tube 524. Pledget
578 is carried on the distal end of stapler 528 and is implanted
with staple 530 to aid in closing arteriotomy 132, as described in
U. S. Published Patent Application Number 2004/0093024 A1 to
Lousararian et al., the entire disclosure of which is incorporated
herein by reference. Pledget 578 may comprise a part of, or
substantially all of planar portion 576 of frangible cap 574'.
Pledget 578 may have circumferentially spaced notches for
fractional engagement with, and centering between the legs of
staple 530, as described in the above-referenced Lousararian
publication,
[0097] As shown in FIG. 30, pledget 578 may promote hemostasia by
stemming the flow of blood from arteriotomy 132 that is being
closed by staple 530. Additionally, pledget 578 may be either
bio-resorbable or non-resorbable, and may Include physiologically
active agents such as Cefazolin, chlorhexidine, fusidic acid,
Novobiocin, polymyxin B, rifampicin, silver or a silver compound,
or tetracycline for inhibition of infection. Alternative
physiologically active agents may include collagen or derivatives
thereof, heparin, or phosphorylcholine for promotion of
extraluminal dotting. Such physiologically active agents may be
coated onto, absorbed within, or otherwise incorporated into the
material of pledget 578.
[0098] While various embodiments of the present disclosure have
been described above, it should be understood that they have been
presented by way of illustration and example only, and not
limitation. It will be apparent to persons skilled in the relevant
art that various changes in form and detail can be made therein
without departing from the spirit and scope of the disclosure.
Thus, the breadth and scope of the present disclosure should not be
limited by any of the above-described exemplary embodiments, but
should be defined only in accordance with the appended claims and
their equivalents. It will also be understood that each feature of
each embodiment discussed herein, and of each reference cited
herein, can be used in combination with the features of any other
embodiment. All patents and publications discussed herein are
incorporated by reference herein in their entirety.
* * * * *