U.S. patent application number 10/618802 was filed with the patent office on 2004-03-25 for endovascular fastener applicator.
This patent application is currently assigned to United States Surgical Corporation. Invention is credited to Parodi, Juan Carlos, Ratcliff, Keith, Rende, Frank M., Sherts, Charles R..
Application Number | 20040059344 10/618802 |
Document ID | / |
Family ID | 22282859 |
Filed Date | 2004-03-25 |
United States Patent
Application |
20040059344 |
Kind Code |
A1 |
Parodi, Juan Carlos ; et
al. |
March 25, 2004 |
Endovascular fastener applicator
Abstract
An endo-vascular fastener applicator is provided for
endo-luminal fastening a prosthetic to a vessel with a fastener.
The applicator includes a tubular body that is configured for
positioning within a vessel; an expandable portion disposed
adjacent distal end of the tubular body, and deployed to support a
prosthetic in contact with an inner surface of a vessel; and a
drive assembly for advancing a fastener into the prosthetic. The
applicator may include a control assembly; and a delivery tube that
is disposed for movement within the tubular body, and which defines
a channel for movement of the drive assembly therewithin. The
delivery tube may include an applicator head having an injection
mount that is disposed for movement relative to the prosthetic. A
method for endo-luminal repairing a damaged portion of a vessel is
also disclosed.
Inventors: |
Parodi, Juan Carlos;
(Capital Federal, AR) ; Ratcliff, Keith; (Newtown,
CT) ; Rende, Frank M.; (Stamford, CT) ;
Sherts, Charles R.; (Westport, CT) |
Correspondence
Address: |
Chief Patent Counsel
U.S. Surgical
A Division of Tyco Healthcare Group, LP
150 Glover Avenue
Norwalk
CT
06856
US
|
Assignee: |
United States Surgical
Corporation
Norwalk
CT
|
Family ID: |
22282859 |
Appl. No.: |
10/618802 |
Filed: |
July 14, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10618802 |
Jul 14, 2003 |
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09787135 |
Jun 4, 2001 |
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6592593 |
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09787135 |
Jun 4, 2001 |
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PCT/US99/21414 |
Sep 17, 1999 |
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60101050 |
Sep 18, 1998 |
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Current U.S.
Class: |
606/108 |
Current CPC
Class: |
A61F 2002/075 20130101;
A61F 2/848 20130101; A61B 17/0682 20130101; A61F 2/07 20130101;
A61B 2017/0649 20130101; A61B 17/064 20130101 |
Class at
Publication: |
606/108 |
International
Class: |
A61F 011/00 |
Claims
What is claimed is:
1. An endovascular fastener applicator for endoluminally fastening
a prosthetic to a vessel with a fastener, the applicator
comprising: a tubular body configured for positioning within a
vessel; an expandable portion disposed adjacent a distal end of the
tubular body and being deployable to support a prosthetic in
contact with an inner surface of a vessel; and a drive assembly for
advancing a fastener into the prosthetic.
2. An endovascular fastener applicator as recited in claim 1,
further comprising a control assembly operatively connected to said
drive assembly for extracorporeal control of the applicator.
3. An endovascular fastener applicator as recited in claim 1,
further comprising a delivery tube being disposed for movement
within the tubular body and defining a channel for movement of the
drive assembly therewithin, the delivery tube being configured for
advancing a fastener within the tubular body.
4. An endovascular fastener applicator as recited in claim 1,
further comprising an elongate control positioned for movement
within the tubular body, wherein the expandable portion is
operatively connected to a distal end of the tubular body and a
distal end of the elongate control, the tubular body and the
elongate control being manipulable to facilitate support of the
prosthetic in contact with an inner surface of a vessel.
5. An endovascular fastener applicator as recited in claim 4,
wherein the elongate control is coaxially disposed with the tubular
body.
6. An endovascular fastener applicator as recited in claim 3,
wherein the delivery tube is coaxially disposed with the tubular
body.
7. An endovascular fastener applicator as recited in claim 1,
wherein the drive assembly is coaxially disposed with the tubular
body.
8. An endovascular fastener applicator as recited in claim 1,
wherein at least a portion of the applicator is fabricated from a
shape memory material.
9. An endovascular fastener applicator as recited in claim 1,
wherein the drive assembly includes a curved portion oriented at an
angle of substantially 90.degree. from a longitudinal axis defined
by the tubular body.
10. An endovascular fastener applicator as recited in claim 1,
wherein the drive assembly is configured for axial and rotational
motion.
11. An endovascular fastener applicator as recited in claim 3,
wherein the delivery tube includes an applicator head configured to
facilitate deployment of a fastener.
12. An endovascular fastener applicator as recited in claim 1,
wherein the expandable portion includes support members that define
open interstitial regions therebetween.
13. An endovascular fastener applicator as recited in claim 12,
wherein the support members comprise a plurality of flexible
wires.
14. An endovascular fastener applicator as recited in claim 12,
wherein the support members comprise a plurality of flexible
tapes.
15. An endovascular fastener applicator as recited in claim 11,
wherein the applicator head has a substantially perpendicular
orientation to a longitudinal axis defined by the delivery
tube.
16. An endovascular fastener applicator as recited in claim 1,
wherein the drive assembly includes a drive rod having a
rectangular cross-section, the drive rod cooperating with an inner
diameter of a fastener whereby movement of the drive rod causes
advancement of a fastener.
17. An endovascular fastener applicator as recited in claim 1,
wherein the applicator is configured to deploy multiple
fasteners.
18. An endovascular fastener applicator as recited in claim 1,
wherein the drive assembly includes at least one fastener guide
configured to guide advancement of a fastener, each fastener guide
cooperates with a prosthetic for guiding advancement of a
fastener.
19. An endovascular fastener applicator as recited in claim 2,
wherein the control assembly includes a handle having a pistol-grip
trigger configuration.
20. An endovascular fastener applicator as recited in claim 11,
wherein the applicator head includes an ejection mount disposed for
movement relative to a prosthetic and configured for deployment of
a plurality of helical fasteners, the ejection mount has an
ejection head with a saw toothed face configured for engaging a
prosthetic, facilitating uniform deployment of each fastener
deployed.
21. An endovascular fastener applicator as recited in claim 20,
further including a ratchet assembly configured to facilitate
movement of the ejection mount.
22. An endovascular fastener applicator system for repairing a
damaged portion of a vessel, the system comprising: at least one
helical fastener, each helical fastener having a penetrating end
and a limiting end; a prosthetic; and an endovascular fastener
applicator including: a tubular body configured for positioning
within a vessel; a delivery tube being disposed for movement within
the tubular body and configured for advancing each helical fastener
within the tubular body, the delivery tube including an applicator
head adjacent a distal end thereof, the applicator head being
configured for deploying each helical fastener and having a
substantially perpendicular orientation relative to a longitudinal
axis defined by the delivery tube; an expandable portion being
operatively connected adjacent the distal end of the tubular body
and including support members that define open interstitial
regions,the support members being configured to support the
prosthetic in contact with an inner surface of the vessel; a drive
assembly being disposed for axial and rotational movement within
the delivery tube, the drive assembly including a drive rod
configured to cooperate with the helical fastener for advancing the
helical fastener and facilitating deployment thereof to the
prosthetic; and a control assembly operatively connected to the
drive assembly for extracorporeal control of the applicator.
23. An endovascular fastener applicator system as recited in claim
22, wherein the applicator head is configured for engaging an
interior portion of the prosthetic to facilitate uniform deployment
of each helical fastener.
24. An endovascular fastener applicator system as recited in claim
22, wherein the drive rod has a cross-section corresponding to an
interior cross-section defined by each helical fastener and in
cooperation facilitates advancement and deployment of each helical
fastener.
25. An endovascular fastener applicator system recited in claim 22,
wherein the prosthetic includes an interior band having anchor pads
circumferentially spaced about and implanted within the band, the
pads corresponding to the open interstitial regions of the
expandable portion, the drive assembly further including guide
wires being configured for guiding advancement of each helical
fastener and having anchor legs adjacent a distal end of each of
the guide wires, the anchor legs releasably engaging the anchor
pads prior to deployment of each helical fastener and being
retractable from the prosthetic upon deployment of each helical
fastener.
26. An endovascular fastener applicator system as recited in claim
22, wherein the applicator head includes an ejection mount being
configured for deploying at least one helical fastener and movable
relative to an interior circumference of the prosthetic for
deploying each helical fastener, the ejection mount including an
ejection head having a saw-toothed face for engaging the internal
circumference of the prosthetic, the ejection head facilitating
uniform deployment of each helical fastener.
27. An endovascular fastener applicator system as recited in claim
26, further including a ratchet assembly being configured to
facilitate movement of the ejection mount.
28. A method for endoluminally repairing a damaged portion of a
vessel, the method comprising the steps of: providing an
endovascular fastener applicator for endoluminally fastening a
prosthetic to a vessel with a fastener, the applicator including: a
tubular body, configured for positioning within a vessel, an
expandable portion disposed adjacent a distal end of the tubular
body and being deployable for supporting a prosthetic in contact
with an inner surface of a vessel, and a drive assembly for
advancing a fastener into a prosthetic; expanding the expandable
portion adjacent an inner surface of the vessel to facilitate
support of a prosthetic in contact with a vessel; advancing a
fastener with the drive assembly to a site for deployment of the
fastener; and deploying the fastener with the drive assembly to
penetrate the prosthetic.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This Patent Application claims the benefit of U.S.
Provisional Application Serial No. 60/101,050 filed Sep. 18, 1998,
by Parodi et al., the entire contents of which are hereby
incorporated by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] This disclosure relates generally to vascular grafts for
intraluminal delivery, and in particular, to a method and apparatus
for repairing diseased or damaged sections of a vessel by fastening
a prosthesis within the vessel.
[0004] 2. Description of Related Art
[0005] Diseased or damaged blood vessels often cause weakening of
the vessel wall resulting in an aneurysm whereby a blood vessel and
especially an artery have a section of abnormal blood-filled
dilation. For example, an abdominal aortic aneurysm is a sac caused
by an abnormal dilation of the wall of the aorta, a major artery of
the body as it passes through the abdomen.
[0006] The abdominal aortic aneurysm usually arises in the
infrarenal portion of the arteriosclerotically diseased aorta, for
example, below the kidneys. Left untreated, the aneurysm will
eventually cause rupture of the sac with ensuing fatal hemorrhaging
in a very short time. High mortality associated with rupturing led
the state of the art into trans-abdominal surgical repair of
abdominal aortic aneurysms.
[0007] Surgery involving the abdominal wall, however, is a major
undertaking with associated high risks. This type of surgery, in
essence, involves replacing the diseased and aneurysmal segment of
blood vessel with a prosthetic device which typically is a
synthetic tube, or graft, usually fabricated of either DACRON.TM.,
TEFLON.TM., or other suitable material.
[0008] The present state of the art for intraluminal repair of a
vessel does not fasten a prosthesis to the remaining aortic wall.
For example, U.S. Pat. Nos. 5,571,171 and 5,571,173 disclose a
method and apparatus for treating an abdominal aortic aneurysm by
supplying a prosthesis or an aortic graft for intraluminal delivery
that does not fasten the graft to the remaining aortic wall.
[0009] Presenting an aortic graft through the aorta by intraluminal
delivery avoids major invasive surgery. The '171 and '173 patents
disclose an aortic graft that is delivered intraluminally to the
aneurysm site. The aortic graft is secured to the remaining aortic
wall by a balloon that is inflated thereby causing the graft to
contact and adhere to the remaining aortic wall.
[0010] The major disadvantages related to the combination of
endovascular expanders, such as a balloon or stent, and prosthesis
is the dilation of the natural artery with consequent migrations
and periprosthetic losses. Upon withdrawal of the expander, the
tissue is caused to collapse and the prosthesis disengages from the
remaining aortic wall and tends to migrate to a location away from
the aneurysm site to be repaired. The migration and movement of the
disengaged aortic graft would then obstruct the affected vessel.
The migration and movement of the aortic graft requires further
treatment on the patient to remove the failed attempt to attach the
aortic graft to the remaining aortic wall.
[0011] Further treatment may include major surgery that is
hazardous and traumatic to the patient. Major surgery to remove the
aortic graft defeats the benefits of intraluminal delivery of the
aortic graft. The current state of the art does not disclose a
fastener applicator that intraluminally delivers a vascular graft
and endoluminally applies internal fasteners to fasten a prosthesis
in place.
[0012] Accordingly, there is a present need for a fastener
applicator that intraluminally delivers a vascular graft to a site
within a vessel and applies fasteners to pass through both a
prosthesis and the thickness of a vessel wall. The fastened
prosthesis should also have the capability of following dilation of
a vessel.
SUMMARY
[0013] An endovascular fastener applicator for endoluminally
delivering protheses for treating a vessel is disclosed. The
endovascular fastener applicator includes a delivery assembly and a
control assembly. The delivery assembly delivers a graft to a site
within a vessel and fastens the prosthesis to a vessel by passing a
fastener therethrough. The delivery assembly may include an outer
sleeve, delivery tube and drive assembly for fastening a prosthesis
to a vessel. The control assembly controls operation of the graft
delivery catheter. At least a portion of the applicator can be
fabricated from a shape memory material. The applicator can be
configured to deploy multiple fasteners.
[0014] In one embodiment, an endovascular fastener applicator is
provided for endoluminally fastening a prosthetic to a vessel with
a fastener, in accordance with the present disclosure. The
applicator includes a tubular body that is configured for
positioning within a vessel. An expandable portion is disposed
adjacent a distal end of the tubular body and is deployable to
support a prosthetic in contact with an inner surface of a vessel.
A drive assembly is also included for advancing a fastener into the
prosthetic. The drive assembly can be coaxially disposed within the
tubular body. The drive assembly may include a curved portion
oriented at an angle of substantially 90.degree. from a
longitudinal axis defined by the tubular body. In an alternate
embodiment, the drive assembly includes a drive rod having a
rectangular cross-section. The drive rod cooperates with an inner
diameter of a fastener whereby movement of the drive rod causes
advancement of a fastener. The drive assembly may be configured for
axial and rotational motion.
[0015] The endovascular fastener applicator may include a control
assembly that is operatively connected to the drive assembly for
extracorporeal control of the applicator. In one embodiment, the
control assembly includes a handle having a pistol-grip trigger
configuration.
[0016] The endovascular fastener applicator may include a delivery
tube that is disposed for movement within the tubular body and
which defines a channel for movement of the drive assembly
therewithin. The delivery tube is configured for advancing a
fastener within the tubular body. The delivery tube can be
coaxially disposed with the tubular body. In another embodiment,
the delivery tube includes an applicator head configured to
facilitate deployment of the fastener. The applicator head may have
a substantially perpendicular orientation to a longitudinal axis
defined by the delivery tube.
[0017] The fastener applicator may also include an elongate control
positioned for movement within the tubular body. The expandable
portion is operatively connected to a distal end of the tubular
body and a distal end of the elongate control. The tubular body and
the elongate control are manipulable to facilitate support of the
prosthetic in contact with an inner surface of a vessel. The
elongate control can be coaxially disposed with the tubular
body.
[0018] The expandable portion may include support members that
define open interstitial regions therebetween. The support members
can comprise a plurality of flexible wires. The support members may
alternatively comprise a plurality of flexible tapes.
[0019] In one embodiment, the drive assembly may include at least
one fastener guide configured to guide advancement of a fastener.
Each fastener guide cooperates with a prosthetic for guiding
advancement.
[0020] In another alternate embodiment, the applicator head
includes an ejection mount that is disposed for movement relative
to a prosthetic and configured for deployment of a plurality of
helical fasteners. The ejection mount has an ejection head with a
saw toothed face which is configured for engaging a prosthetic. A
ratchet assembly may be included that is configured to facilitate
movement of the ejection mount.
[0021] In yet another alternate embodiment, an endovascular
fastener applicator system is disclosed for repairing a damaged
portion of a vessel. The system includes at least one helical
fastener and a prosthetic. Each helical fastener having a
penetrating end and a limiting end. An endovascular fastener
applicator, as discussed above, is also included. An applicator
head, as discussed above, may be included, that is configured for
engaging an interior portion of the prosthetic to facilitate
uniform deployment of each helical fastener. A drive rod may have a
cross-section corresponding to an interior cross-section defined by
each helical fastener, and in cooperation, facilitate advancement
and deployment of each helical fastener.
[0022] In an alternate embodiment, the prosthetic includes an
interior band having anchor pads circumferentially spaced about and
implanted within the band. The pads correspond to the open
interstitial regions of the expandable portion. The drive assembly
includes guide wires configured for guiding advancement of each
helical fastener and have anchor legs adjacent a distal end of each
of the guide wires. The anchor legs releasably engage the anchor
pads prior to deployment of each helical fastener and are
retractable from the prosthetic upon deployment of each helical
fastener.
[0023] The applicator head may include an ejection mount configured
for deploying at least one helical fastener and movable relative to
an interior circumference of the prosthetic for deploying each
helical fastener. The ejection mount includes an ejection head
having a saw-toothed face for engaging the internal circumference
of the prosthetic. The ejection head facilitates uniform deployment
of each helical fastener.
[0024] A method for endoluminally repairing a damaged portion of a
vessel is disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Various embodiments are described herein with reference to
the drawings, wherein:
[0026] FIG. 1 is a perspective view of one embodiment of an
endovascular fastener applicator in accordance with the present
disclosure;
[0027] FIG. 2 is a cross-sectional view, in part elevation, of an
aortic graft placed at the site of an abdominal aortic aneurysm
within the aorta;
[0028] FIG. 3 is an enlarged detail view of a portion of FIG. 2
illustrating the aortic graft secured to the remaining aortic wall
and maintained in position by helical fasteners;
[0029] FIG. 4 is a cross-sectional view, in part elevation, of an
aortic graft for treating an aortic aneurysm affecting the aorta
and both ileac arteries;
[0030] FIG. 5 is a perspective view of a helical fastener;
[0031] FIG. 6 is a side elevation view of a helical fastener;
[0032] FIG. 7 is a bottom perspective view taken along line 7-7 of
FIG. 6 of a helical fastener having a rectangular configuration at
its limiting end for cooperating with a rectangular drive
assembly;
[0033] FIG. 8 is a cross-sectional view taken along line 8-8 of
FIG. 7 of a helical fastener;
[0034] FIG. 9 is a cross-sectional view, in part elevation, of an
endovascular fastener applicator;
[0035] FIG. 10 is a cross-sectional view, in part elevation, of a
distal portion of the applicator at the aneurysm site;
[0036] FIG. 11 is a cross-sectional view of the control
assembly;
[0037] FIG. 12 is a cross-sectional view, in part elevation, of the
applicator at the ancurysm site showing an expandable portion
causing a prosthesis to contact a vessel wall;
[0038] FIG. 13 is a cross-sectional view of the control
assembly;
[0039] FIG. 14 is a cross-sectional view, in part elevation, of the
applicator at the aneurysm site showing advance of a delivery
tube;
[0040] FIG. 15 is a cross-sectional view of the control
assembly;
[0041] FIG. 16 is a cross-sectional view, in part elevation, of the
applicator at the aneurysm site showing advance of a drive
assembly;
[0042] FIG. 17 is a top view of a helical fastener defining a
rectangular configuration at its limiting end for cooperating with
a rectangular drive assembly, as shown in cross-section;
[0043] FIG. 18 is a cross-sectional view of the control
assembly;
[0044] FIG. 19 is a cross-sectional view, in part elevation, of the
delivery assembly showing rotation for insertion of a helical
fastener;
[0045] FIG. 20 is a cross-sectional view, in part elevation, of an
alternate embodiment of the applicator showing the delivery
assembly at the aneurysm with fastener guides;
[0046] FIG. 21 is an enlarged detail view of a portion of FIG. 20
illustrating a helical fastener guided over a drive attached to a
fastener guide;
[0047] FIG. 22 is a cross-sectional view, in part elevation, of a
helical fastener taken along line 22-22 of FIG. 21;
[0048] FIG. 23 is a plan view, in part cross-section, taken along
line 23-23 of FIG. 20 showing the applicator with fastener
guides;
[0049] FIG. 24 is a perspective view of one embodiment of a
fastener guide in accordance with the present disclosure;
[0050] FIG. 25 is a perspective view, in part cross-section,
showing movement of the helical fastener over a drive prior to
collapsing the fastener guide;
[0051] FIG. 26 is a perspective view, in part cross-section,
showing the drive after the fastener guide is collapsed and the
helical fastener deployed;
[0052] FIG. 27 is a perspective view, showing retraction of the
drive and fastener guide;
[0053] FIG. 28 is a perspective view of an alternate embodiment of
the control assembly;
[0054] FIG. 29 is a perspective view of the distal end of an
alternate embodiment of the drive assembly loaded with a plurality
of helical fasteners;
[0055] FIG. 30 is a perspective view showing a helical fastener for
loading with a channel of the drive assembly;
[0056] FIG. 31 is a perspective view of an alternate embodiment of
a helical fastener;
[0057] FIG. 32 is a perspective view of an applicator head and
helical fasteners prior to deployment into a prosthesis;
[0058] FIG. 33 is a perspective view of the helical fastener
deployed into the prosthesis and artery;
[0059] FIG. 34 is a perspective view of an alternate embodiment of
the applicator showing the expandable portion in an expanded
state;
[0060] FIG. 35 is a perspective view of the expandable portion
shown in FIG. 34 in a relaxed state;
[0061] FIG. 36 is an exploded view of the delivery assembly shown
in FIG. 34;
[0062] FIG. 37 is an exploded view of the drive assembly shown in
FIG. 34;
[0063] FIG. 38 is a perspective view of the drive assembly shown in
FIG. 34;
[0064] FIG. 39 is a perspective view of an embodiment of an
ejection mount;
[0065] FIG. 40 is a perspective view of the ejection mount showing
a set screw and cam divider for cooperating with the drive
assembly;
[0066] FIG. 41 is a cross-sectional view of the applicator with the
expandable portion in a relaxed state and a prosthetic having a
sealing gasket;
[0067] FIG. 42 is a cross-sectional view, in part elevation, of the
distal end of the applicator;
[0068] FIG. 43 is a cross-sectional view, in part elevation, with
the expandable portion in an expanded state;
[0069] FIG. 44 is an enlarged cross-sectional view, in part
elevation, of the distal end of the applicator;
[0070] FIG. 45 is a perspective view of the expandable portion in
an expanded state and the ejection mount loaded with helical
fasteners;
[0071] FIG. 46 is a cross-sectional view, in part elevation, with
the ejection. mount pivoted for deployment of helical
fasteners;
[0072] FIG. 46A is a perspective view, in part cross-section, an
alternate embodiment of the ejection mount pivoted for deployment
of helical fasteners;
[0073] FIG. 47 is a cross-sectional view, in part elevation, of the
ejection mount engaging the aortic graft prior to deployment of
helical fasteners;
[0074] FIG. 48 is a perspective view, in part cross-section,
showing deployment of helical fasteners;
[0075] FIG. 49 is a perspective view, in part cross-section,
showing retraction of the ejection mount;
[0076] FIG. 50 is a cross-sectional view, in part elevation,
showing the ejection mount subsequent to deployment of a helical
fastener; and
[0077] FIG. 51 is a top view of the applicator, showing movement of
the ejection mount prior to deployment of a helical fastener.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0078] As illustrated in FIG. 1, the present disclosure relates to
an endovascular fastener applicator, generally referred to as
numeral 50. Endovascular fastener applicator 50 delivers aortic
graft 100, as shown in FIGS. 2 and 3, for repairing an abdominal
aortic aneurysm 120 in aorta 124 having two iliac arteries 126L and
126R associated therewith, as well as a plurality of renal arteries
130 located above aneurysm 120 in fluid communication with aorta
124. Repairing the aneurysm includes fastening an aortic graft 100
to an aortic wall 132 by fasteners 80. Aortic graft 100, as well as
other prostheses, may be utilized in the thoracic aorta, and can be
used to repair thoracic aneurysms or thoracic dissecting aneurysms.
Further, the fastener applicator 50 may also treat vascular trauma
and other obstructive diseases with various prostheses.
Accordingly, use of the term aortic aneurysm in this specification
and claims is intended to relate to and mean both abdominal aortic
aneurysms, thoracic aneurysms and related vessel diseases.
[0079] Endovascular fastener applicator 50 has a delivery assembly
60 and a control assembly 140. Delivery assembly 60, as illustrated
in FIG. 9, includes a tubular body, such as, for example, an outer
sleeve 64, an elongate control 68, a delivery tube 72 and a drive
assembly 76, each having a proximal and distal end relative to
control assembly 140. Outer sleeve 64 defines a channel 65 and is
adapted for insertion within aorta 124(as shown in FIG. 10) and has
an expandable portion 66 operatively connected at its distal end.
Elongate control 68 is coaxially positioned within channel 65 of
outer sleeve 64 and is operatively connected to expandable portion
66 at its distal end. Delivery tube 72 defines a channel 71 and is
coaxially positioned within channel 65 of outer sleeve 64 and
adapted for advancing a helical fastener 80 to the abdominal aortic
aneurysm site. Drive assembly 76 is coaxially positioned within
channel 71 of delivery tube 72 and adapted for advancing, in
cooperation with delivery tube 72, and deploying helical fastener
80 into aortic graft 100 and aorta wall 132. It is contemplated
that the components of the delivery assembly may be alternately
oriented relative to each other, such as, for example, bi-axial,
offset, etc. It is further contemplated that the components of
delivery assembly 60 are flexible and may be constructed from a
shape memory material.
[0080] Operation of endovascular fastener applicator 50 is
controlled by control assembly 140. As shown in FIGS. 1 and 9,
control assembly 50 includes outer sleeve push bar 146, expandable
portion control 150, delivery tube push bar 148 and handle 144.
Outer sleeve push bar 146 is operatively connected to the proximal
end of outer sleeve 64 for regulating movement of outer sleeve 64.
Expandable portion control 150 is operatively connected to the
proximal end of elongate control 68, which in turn is connected to
expandable portion 66. Correspondingly, expandable portion control
150 controls the expansible force AA (shown in FIG. 12) exerted by
expandable portion 66 for supporting aortic graft 100 in contact
with aortic wall 132. Outer sleeve push bar 146 may also be adapted
to influence expansible force AA.
[0081] Delivery tube push bar 148 is operatively connected to the
proximal end of delivery tube 72 for regulating movement of
delivery tube 72. Handle 144 is operatively connected to the
proximal end of drive assembly 76, for controlling axial and
rotational movement of drive assembly 76, described in detail
below.
[0082] As shown in FIG. 9, drive assembly 76 includes a drive 78.
Drive 78 at its distal end has a curved portion 79 oriented at
substantially 90.degree. to the longitudinal axis of outer sleeve
64 and delivery tube 72 (similarly shown in FIGS. 10 and 12). It is
contemplated that the curved portion may be positioned at various
angular orientations. Drive assembly 76 transmits rotational motion
from its proximal end to its distal end and through its curved
portion 79 to facilitate deployment of helical fasteners 80 into
the aortic graft 100 and aortic wall 132.
[0083] In one embodiment, as illustrated in FIGS. 5-8, helical
fasteners 80 have a sharpened distal end 81 and a penetration limit
end 82. Helical fastener 80 has an outer diameter 83 and an inner
diameter 84. Outer diameter 84 facilitates penetration of sharpened
distal end 81 into aortic graft 100 and aortic wall 132. The
surface of inner diameter 84 cooperatively engages drive assembly
76 and delivery tube 72 at their distal ends to facilitate loading
of helical fastener 80 into endovascular fastener applicator 50.
Preferably, inner diameter 84 and penetration limit end 82 have a
rectangular configuration for cooperative engagement with drive
assembly 76, drive assembly 76 also having a rectangular
configuration at its distal end. Although a helical fastener is
disclosed it is contemplated that fastener 80 may have various
configurations, such as, for example, cylindrical, triangular, etc.
It is further contemplated that fasteners 80 are of the metallic
fastener staple type and are preferably made from stainless steel
but may be constructed from a polymeric material.
[0084] In the embodiment illustrated in FIG. 9, drive 78 is made
from a shape memory alloy whereby drive 78 assumes the curved
configuration of curved portion 79 upon exiting delivery tube 72.
Delivery tube 72 may also include an applicator head 73 at its
distal end having a curved orientation to facilitate deployment of
helical fasteners 80, as shown in FIGS. 14, 16 and 19. Helical
fasteners 80, as shown in FIG. 3, are deployed into aortic graft
100 and aortic wall 132 for fastening.
[0085] In an alternate embodiment, repair of abdominal aortic
aneurysm 120, as shown in FIG. 10, proceeds by insertion of
endovascular fastener applicator 50 into aorta 124 and advancing to
the abdominal aortic aneurysm site by manipulation by a surgeon of
control assembly 140. Endovascular fastener applicator 50 delivers
aortic graft 100 to abdominal aortic aneurysm 120 by advancing the
aortic graft 100 so that a sufficient portion of aortic graft 100
is brought in contact with aortic wall 132. Aortic graft 100 is a
conventional tubular graft made of DACRON.RTM., TEFLON.RTM.
(polytetrafluoroethylene) and the like and is of a length
sufficient to span the abdominal aortic aneurysm 120.
[0086] With reference to FIGS. 11-19, delivery assembly 60 and
aortic graft 100 are delivered to the abdominal aneurysm site by
manipulation of outer sleeve push bar 146, as shown by arrows A in
FIG. 11. Aortic graft 100 is positioned at the abdominal aneurysm
site. Expandable portion 66 is caused to expand, shown by arrows AA
in FIG. 12, in response to cooperative manipulation of outer sleeve
push bar 146 and elongate control 68. Outward radial force AA
supports aortic graft 100 in contact with aortic wall 132.
Expandable portion 66 facilitates fastening of aortic graft 100
with aortic wall 132 by deployment of helical fasteners 80. In this
embodiment, expandable portion 66 includes support members 67 that
define interstitial regions 70 therebetween. Helical fasteners 80
are deployed through interstitial regions 70 and into aortic graft
100. It is contemplated that helical fasteners 80 may be deployed
at various locations about the circumference of aortic graft 100
relative to the number of support members 67 and spacing of
interstitial regions 70.
[0087] Delivery tube push bar 148 is manipulated to axially advance
delivery tube 72 within outer sleeve 64, as shown by arrows B in
FIG. 13. At its distal end, delivery tube 72 has an applicator head
73 configured to have a substantially perpendicular orientation to
the longitudinal axis of delivery tube 72. Drive 78 follows the
substantially perpendicular orientation of delivery tube 72 to
facilitate deployment of helical fasteners 80. It is contemplated
that applicator head 73 may have various configurations and
orientations to facilitate deployment of helical fasteners 80.
[0088] With reference to FIG. 14, delivery tube 72 is advanced to a
location where aortic graft 100 will be fastened to aortic wall
132. A loaded helical fastener 80 is oriented for deployment by
applicator head 73, as shown by arrows C. Applicator head 73 is
articulable in a clockwise and a counter-clockwise direction about
the inner surface of graft 100. The surface of inner diameter 84
and penetration limit end 82 of helical fastener 80 have a
rectangular configuration for cooperative engagement with drive
assembly 76, drive assembly 76 also having a rectangular
configuration at its distal end(FIG. 17). It is contemplated that
the remainder of drive assembly 76 may not be in cooperative
engagement with the surface of inner diameter 84. Helical fastener
80 has a substantially circular cross-section. It is envisioned
that other cross-sectional configurations may be used that are
suitable for fastening.
[0089] With reference to FIGS. 15 and 16, handle 144 is manipulated
to advance drive assembly 76. A torque is applied to handle 144
transmitting a rotational force from the proximal end to the distal
end of drive assembly 76. The rectangular configuration of drive
assembly 76 cooperates with the rectangular configuration of the
surface of inner diameter 84 causing rotational movement of helical
fastener 80. The sharpened distal end 81 of helical fastener 80
contacts the interior wall 102 of aortic graft 100 thereby
facilitating deployment of fastener 80 into aortic graft 100 and
aortic wall 132. Helical fastener 80 penetrates aortic graft 100
and aortic wall 132 to penetration limit end 82 thereby fastening
aortic graft 100 to aortic wall 132.
[0090] In the embodiment shown in FIG. 19, delivery tube 72
cooperates with elongate control 68 at junction 69. Junction 69
facilitates rotation of delivery tube 72 and drive assembly 76
positioned coaxially therewithin, to a location for deployment of
helical fasteners 80, as shown in FIG. 19 by arrow D. Junction 69
rotates by manipulation of expandable portion control 150, as shown
in FIG. 18. Delivery tube 72 is retracted from the fastening site
and loaded with another helical fastener 80 for subsequent
deployment at another location along the diameter of aortic graft
100. As many helical fasteners 80 may be deployed as are necessary
to adequately fasten aortic graft 100 to aortic wall 132. Fastening
in this manner prevents periprosthetic losses and accidental
migration of aortic graft 100. It is contemplated that
multiple-helical fasteners 80 may be loaded into endovascular
fastener applicator 50.
[0091] In another embodiment, as shown in FIGS. 20-27, endovascular
fastener applicator 50 positions aortic graft 100 at the aneurysm
site and in contact with aortic wall 132. Referring to FIG. 20
aortic graft 100 includes band 104 having anchor pads 107 implanted
therewithin. As shown in FIG.23, anchor pads 107 are implanted
circumferentially about band 104. Band 104 may be fabricated from,
such as, for example, polytetrafluoroethylene. Anchor pads 107, are
implanted within band 104 corresponding to interstitial regions 70
located between support members 67 of expandable portion 66.
Referring to FIG. 23, pads 107 have a substantially circular
configuration. It is envisioned that the pads may have other
configurations such as, for example, rectangular, elliptical,
etc.
[0092] Anchor pads 107 cooperatively engage fastener guides 106
positioned at the distal end of drive assembly 76. Anchor pads 107
and fastener guides 106 cooperate to provide a guided deployment of
helical fasteners 80 and facile release of drive assembly 76 from
the aneurysm site. Referring to FIGS. 21 and 22, drive assembly 76
further includes multiple guide wires 77 releasably attached to
fastener guides 106. Guide wires 77 facilitate guided travel of
fasteners 80.
[0093] Referring back to FIG. 24, fastener guides 106 include
anchor legs 108. Anchor legs 108 are resiliently biased so that
upon deployment of helical fastener 80, anchor legs 108 are caused
to collapse and release from band 104. Anchor legs 108 are
connected to multiple guide wires 77 so that after collapse and
release of anchor legs 108, multiple guide wires 77 are retracted
from the fastening site. Anchor pad 107 is retained within band 104
after helical fastener 80 is deployed.
[0094] As shown in FIG. 25, expandable portion 66 supports aortic
graft 100 in contact with aortic wall 132. Applicator head 73 of
delivery tube 72 is configured and dimensioned to cooperate with
inner diameter 84 to advance a helical fastener 80 over multiple
guide wires 77, as shown by arrows E. As helical fastener 80 is
deployed, anchor legs 108 are caused to collapse, shown by arrows F
in FIG. 26. Delivery tube 72 causes rotational movement of helical
fastener 80 and corresponding penetration of band 104, aortic graft
100 and aortic wall 132, facilitating fastening.
[0095] Delivery tube 72 is retracted subsequent to deployment of
helical fastener 80 and multiple guide wire 77 is also retracted,
as shown in FIG. 27, with helical fastener 80 in a deployed
position. Delivery tube 72 is subsequently loaded with another
helical fastener 80 for deployment from another of multiple guide
wires 77. As many helical fasteners 80 may be deployed as are
necessary to adequately fasten aortic graft 100 to aortic wall 132.
It is contemplated that at least a portion of the fastener guides
and/or guide wires may remain fixed to the prosthetic upon
deployment of a fastener.
[0096] In another embodiment as shown in FIG. 28, control assembly
140 includes a handle 110 and a trigger 120 for controlling
operation of endovascular fastener applicator 50. In this
embodiment, handle 110 controls advancement of delivery tube 72
(not shown) and trigger 120 controls advancement of drive assembly
76 (not shown) and deployment of helical fasteners 80 (not
shown).
[0097] In another embodiment, as illustrated in FIGS. 29-33, a
plurality of helical fasteners 80 are loaded in endovascular
fastener applicator 50 for deployment. As shown in FIG. 30, drive
assembly 76 defines a channel 75 for accepting helical fasteners 80
(FIG. 31). In particular, penetration limit end 82 of helical
fastener 80 slidably engages channel 75 providing a plurality of
helical fasteners 80 for deployment, as shown in FIG. 29.
Applicator head 73 of delivery tube 72 engages band 104, as shown
in FIG. 32, and drive assembly 76 advances helical fasteners 80 to
penetrate band 104, aortic graft 100 and aortic wall 132, shown by
arrows G. As shown in FIG. 33, aortic graft 100 is fastened to
aortic wall 132 of aorta 124 by helical fastener 80. After
deployment of a helical fastener 80, delivery tube 72 is rotated to
deploy another of the plurality of helical fasteners 80,
consequently reloading is not required.
[0098] In another embodiment, as illustrated in FIGS. 34-51,
expandable portion 66 is capable of moving between two extreme
positions. A relaxed position, as shown in FIG. 35, and an expanded
position, as shown in FIG. 34. In the embodiment illustrated in
FIG. 34, expandable portion 66 includes support members 67 that
define open interstitial regions 70.
[0099] As best shown in FIG. 36, outer sleeve 64 operatively
engages with expandable portion 66 for controlling operation
between the two extreme positions. Expandable portion 66 has an
atraumatic head 200 attached to opening 210 defined at the distal
end of expandable portion 66 and opening 212 defined at its
proximal end for receiving applicator head 73 of delivery tube 72.
Applicator head 73 includes ejection mount 250 for deployment of a
plurality of helical fasteners 80 from drive assembly 76.
[0100] Ejection mount 250, as shown in FIG. 36, includes yoke 256
and ejection head 260. Yoke 256 engages penetration head 200 for
coaxial positioning within expandable portion 66. Ejection head 260
is pivotally positioned within yoke 256. Ejection head 260 includes
a cam divider 262 and a saw-toothed face 264. Ejection head 260 is
capable of rotational movement relative to delivery tube 72 and
pivotal movement between two extreme positions. A first extreme
position is coaxial with delivery tube 72 and a second extreme
position is perpendicular to the longitudinal axis of delivery tube
72 and in position to deploy a helical fastener 80.
[0101] With reference to FIGS. 37 and 38, drive assembly 76
includes distal drive 280, proximal drive 284, outer drive 285,
ratchet assembly 286, spring 294 and washer 296. Distal drive 280
defines a slot 281 for receiving penetration limit end 82 for
loading a plurality of helical fasteners 80. The plurality of
helical fasteners 80 are spring loaded onto drive assembly 76 and
separated from spring 294 by washer 296.
[0102] Distal drive 280 is operatively connected to ratchet
assembly 286 which is operatively connected to proximal drive 284
and outer drive 285. Ratchet assembly 286 includes ratchet sleeve
287 which defines opening 288 for receipt of distal drive 280.
Manipulation of proximal drive 284 causes movement of distal drive
280 to facilitate deployment of helical fasteners 80. Ratchet
sleeve 287 also defines opening 289 for receipt of proximal drive
284. Ratchet sleeve 287 is slidably received within ratchet
retainer 290 for cooperative engagement with outer drive 285.
Ratchet retainer 290 defines opening 291 for receiving ratchet arm
292.
[0103] As shown in FIGS. 39 and 40, ratchet arm 292 engages
ejection head 260. Ratchet arm 292 is positioned within cam divider
262 in ejection head 260 and secured therein by set screw 298. It
is contemplated that ratchet arm 292 is crimped in place within
ejection head 260 and that no set screw is required. It is further
contemplated that ratchet arm 292 may be fixed within ejection head
260 as is known by one skilled in the art. Manipulation of outer
drive 285 engages ratchet retainer 290 and ratchet arm 292 causing
pivotal movement of ejection head 260 relative to delivery tube
72.
[0104] As illustrated in FIGS. 41 and 42, delivery assembly 60 is
positioned at the aneurysm site of abdominal aortic aneurysm 120.
Aortic graft 100 is positioned for fastening to aortic wall 132 of
aorta 124. Aortic graft 100 has band 104. Aortic graft 100 may also
have gasket 105, as shown in FIG. 41, sewn to the outside diameter
of aortic graft 100 to prevent leakage of fluid.
[0105] Expandable portion 66 is in a relaxed state, as shown in
FIGS. 41 and 42. Aortic graft 100 is positioned at the abdominal
aneurysm site and expandable portion 66 is caused to expand by
axial motion of outer sleeve 64, shown by arrows I in FIG. 44 and
by arrows H in FIG. 43, illustrating the outward force of support
members 67 used to support aortic graft 100 in contact with aortic
wall 132. Expandable portion 66 facilitates fastening of aortic
graft 100 with aortic wall 132 for deployment of helical fasteners
80 by securing aortic graft 100 in contact with aortic wall 132. It
is contemplated that helical fasteners 80 may be deployed from
ejection mount 250 through interstitial regions 70 between support
members 67. The helical fasteners 80 are deployed about the
circumference of aortic graft 100 relative to the number of support
members 67 and spacing of interstitial regions 70.
[0106] As shown in FIG. 45, drive assembly 76 is loaded with a
plurality of helical fasteners 80. Referring to FIG. 46, delivery
tube 72 has an ejection arm 310 positioned at its distal end
facilitating pivotal movement of ejection mount 250. An arm 292
functions as an ejection arm to ejection head 260. This provides
extra holding force on the graft which pivots ejection head 260
positioned at its distal end. Ejection arm 310 includes a slider
312 received within a cam slot 300 defined by ejection head 260.
Cam slot 300 further defines the relative movable limits of slider
312 and thus ejection arm 310.
[0107] Delivery tube 72 is manipulated advancing ejection arm 310
axially causing pivotal movement of ejection head 260, shown by
arrow J, and positioning ejection head 260 for deployment of
helical fasteners 80. Ejection head 260 is positioned in a
substantially perpendicular orientation to the longitudinal axis of
delivery tube 72.
[0108] It is contemplated that ejection arm 310 has alternate
orientations for causing movement of ejection head 260. For
example, in an alternate embodiment shown in FIG. 46A, ejection
head 260 pivots within expandable portion 66 and is positioned at
the center of expandable portion 66. Saw-toothed face 264 is
positioned at a closer proximity to the inner surface of graft 100
for accurate deployment of a fastener. At the center position,
ejection head 260 spans a diameter that expandable portion 66
supports aortic graft 100 in contact with aortic wall 132. In this
embodiment, ejection arm 310 is fixed at a maximum angle relative
to delivery tube 72.
[0109] Drive assembly 76 is manipulated so that ejection head 260
engages band 104 of aortic graft 100 for deployment of helical
fasteners 80, as illustrated in FIG. 47. Outer drive 285 and
proximal drive 284 are advanced, shown by arrows K. Ejection arm
292 correspondingly axially positions saw-tooth face 264 of
ejection head 260 to contact band 104 of aortic graft 100, as shown
by arrow L. Ejection arm 292 may also cause rotational movement of
ejection head 260 and saw-tooth face 264 for engaging aortic graft
100.
[0110] With reference to FIG. 48, distal drive 280 advances and is
rotated causing helical fasteners 80 to penetrate and fasten aortic
graft 100 and aortic wall 132, as shown by arrow M.
[0111] As shown in FIG. 49, delivery tube 72 is manipulated so that
ejection arm 310 pivotally retracts ejection head 260 to a position
substantially parallel to the longitudinal axis of delivery tube
72, as shown by arrows MM.
[0112] FIG. 50 illustrates a retracted ejection mount 250
subsequent to deployment of one of a plurality of helical fasteners
80. A rotational force is transmitted from the proximal end to the
distal end of drive assembly 76, shown by arrows N, thereby driving
and axially advancing another of the plurality of helical fasteners
80, shown by arrows P, for deployment by ejection head 260 at a new
deployment site.
[0113] FIG. 51 shows ejection head 260 positioned in a
substantially perpendicular orientation to the longitudinal axis of
delivery tube 72(not shown). Ejection head 260 is rotated to a new
deployment site to deploy another of the plurality of helical
fasteners 80 (not shown). As many helical fasteners 80 may be
deployed as are necessary to adequately fasten aortic graft 100 to
aortic wall 132.
[0114] It will be understood that various modifications may be made
to the embodiments disclosed herein. For example, while specific
preferred embodiments of the endovascular fastener applicator have
been described in detail, structures that perform substantially the
same function in substantially the same way to achieve
substantially the same result may also be used. For example, the
expandable portion may include expanding wires for supporting a
prostheses in contact with a vessel wall. Also the fastener guide
may be implanted completely through the thickness of the aortic
graft. Further, the helical fasteners may be constructed from
various suitable materials or may embody one continuous fastener
that is severable at the point of insertion. Therefore, the above
description should not be construed as limiting, but merely as
exemplifications of preferred embodiments, those skilled in the art
will envision other modifications within the scope and spirit of
the present disclosure.
* * * * *