U.S. patent application number 10/454896 was filed with the patent office on 2003-11-27 for endovascular apparatus.
This patent application is currently assigned to SCIMED LIFE SYSTEMS, INC.. Invention is credited to Bilge, Fertac, Buscemi, Paul J., Donabedian, David H., Holman, Thomas J., Thometz, Darlene A..
Application Number | 20030220684 10/454896 |
Document ID | / |
Family ID | 24405224 |
Filed Date | 2003-11-27 |
United States Patent
Application |
20030220684 |
Kind Code |
A1 |
Holman, Thomas J. ; et
al. |
November 27, 2003 |
Endovascular apparatus
Abstract
Percutaneous treatment of aortic aneurysms and like vascular
anomalies by an apparatus and method wherein the apparatus is
delivered via catheter and comprises a sleeve with at least one
peripheral conduit which is caused to assume an expanded, rigid
configuration by the introduction of a chemical or mechanical
hardening means, whereby the sleeve is caused to assume an open
cylindrical configuration for fluid flow therethrough.
Inventors: |
Holman, Thomas J.;
(Minneapolis, MN) ; Thometz, Darlene A.; (Maple
Grove, MN) ; Bilge, Fertac; (South Lake, TX) ;
Buscemi, Paul J.; (Long Lake, MN) ; Donabedian, David
H.; (Somerset, NJ) |
Correspondence
Address: |
VIDAS, ARRETT & STEINKRAUS, P.A.
6109 BLUE CIRCLE DRIVE
SUITE 2000
MINNETONKA
MN
55343-9185
US
|
Assignee: |
SCIMED LIFE SYSTEMS, INC.
Maple Grove
MN
|
Family ID: |
24405224 |
Appl. No.: |
10/454896 |
Filed: |
June 3, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10454896 |
Jun 3, 2003 |
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10369910 |
Feb 18, 2003 |
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10369910 |
Feb 18, 2003 |
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10003218 |
Oct 30, 2001 |
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10003218 |
Oct 30, 2001 |
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09566335 |
May 8, 2000 |
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6319276 |
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09566335 |
May 8, 2000 |
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09111264 |
Jul 6, 1998 |
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6059823 |
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09111264 |
Jul 6, 1998 |
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08600834 |
Feb 13, 1996 |
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5871537 |
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Current U.S.
Class: |
623/1.21 ;
623/23.67 |
Current CPC
Class: |
A61B 2017/1205 20130101;
A61B 2017/12127 20130101; A61F 2/89 20130101; A61F 2002/072
20130101; A61B 2017/00535 20130101; A61B 17/12118 20130101; A61F
2/94 20130101; A61B 17/12045 20130101; A61B 2017/00004 20130101;
A61F 2002/065 20130101; A61F 2002/075 20130101; A61F 2250/0003
20130101; A61F 2/954 20130101; A61F 2/95 20130101; A61F 2/07
20130101 |
Class at
Publication: |
623/1.21 ;
623/23.67 |
International
Class: |
A61F 002/06 |
Claims
What is claimed is:
1. A vascular graft device comprising: a) a flexible, tubular
sleeve configuration having at least one axis therethrough and
further comprising a first end, at least one opposite end and an
exterior portion; b) at least one peripheral conduit surrounding
said sleeve, each said at least one peripheral conduit having an
inlet port; c) delivery means connected to at least one conduit at
its inlet port, said delivery means being in association with a
hardening means; whereby when the device is delivered to an area of
a vessel having an aneurysm such that the device is positioned at
the aneurysm and the hardening means is delivered, the hardening
means causes the at least one peripheral conduit to assume an
expanded, rigid configuration which fits securely into the vessel
and is anchored thereto by pressure, causing the sleeve to be
supported in an open condition for fluid flow therethrough.
2. The device of claim 1 further comprising at least one additional
conduit surrounding the sleeve, said additional conduit being
located at the first end of the sleeve.
3. The device of claim 1 further comprising a plurality of conduits
surrounding the sleeve, said conduits being located between the
first end and an opposite end of the sleeve.
4. The device of claim 1 further comprising an enclosure over the
exterior portion of the sleeve between the first end and an
opposite end thereof.
5. The apparatus of claim 1 wherein the hardening means comprises
an activatable hardening material selected from the group
consisting of one-part polymer systems, two-part polymer systems
and self-expanding monomers, the apparatus further comprising a
source of hardening material in association with the delivery
means.
6. The apparatus of claim 5 wherein the hardening means further
comprises at least one receptacle containing the activatable
hardening material.
7. The apparatus of claim 6 further comprising a plurality of
microspheres wherein the activatable hardening material is carried,
said microspheres being located within the receptacle and further
being constructed and arranged to release the activatable hardening
material upon disruption, thereby allowing the activatable
hardening material to harden.
8. The apparatus of claim 6 wherein the activatable hardening
material comprises a first component and a second component
isolated from each other by and carried in said microspheres, said
microspheres being constructed and arranged to release said first
and second components upon disruption, thereby allowing the
components to react and harden.
9. The device of claim 1 wherein each said at least one peripheral
conduit has an outlet port, whereby when the device is delivered to
an area of an artery having an aneurysm such that the device is
positioned at the aneurysm and hardening means is introduced, the
peripheral conduits are substantially filled with hardening means
and are thereby caused to assume an expanded, rigid configuration
which fits securely into the vessel and is anchored thereto by
pressure, causing the sleeve to be supported in an open condition
for fluid flow therethrough.
10. The device of claim 9 further comprising at least one
additional conduit surrounding the sleeve, said additional conduit
being located between the first end and an opposite end of the
sleeve.
11. A vascular graft device comprising: a) a flexible tubular
sleeve configuration having at least one axis therethrough and
further comprising a first end, at least one second end, an
interior portion and an exterior portion; b) a peripheral conduit
surrounding each of said ends, each peripheral conduit having at
least one entrance port; and c) introduction means in communication
with the port of each end tube for introduction of a hardening
means; whereby when the device is delivered to an area of an artery
having an aneurysm such that the sleeve is positioned at the
aneurysm, and hardening means is introduced, the peripheral
conduits are caused to assume an expanded, rigid configuration
which fits securely into the artery and is anchored thereto by
pressure, causing the sleeve to be supported in an open condition
for fluid flow therethrough.
12. An apparatus for repairing an arterial aneurysm, the apparatus
comprising: a) a catheter delivery means; and b) an arterial graft
device comprising: i) a flexible, tubular sleeve configuration
having at least one axis therethrough and further comprising a
first end, at least one opposite end, and exterior and interior
portions; ii) a peripheral conduit surrounding the sleeve and
having at least one port; iii) introduction means associated with
the catheter delivery means and being in communication with each at
least one port; and iv) hardening means delivered through said
introduction means for causing the arterial graft device to assume
a rigid cylindrical configuration; whereby when the apparatus is
delivered to an area of an artery having an aneurysm such that the
sleeve is positioned at the aneurysm and hardening means is
introduced, the conduits are caused to assume a rigid, expanded
configuration which fits securely into the artery and is anchored
thereto by pressure, causing the sleeve to be supported in an open
condition for fluid flow therethrough, and causing the aneurysm to
be repaired.
13. The apparatus of claim 12 wherein the sleeve is made of a
nonbiodegradable, biocompatible polymeric material.
14. The apparatus of claim 13 wherein the polymeric material is
selected from the group consisting of thermosetting polymers,
thermoplastic polymers, thermoplastic elastomers, elastomers,
composites, pseudo-thermoplastics, carbohydrates, proteins, and
mixtures thereof.
15. The apparatus of claim 12 wherein the sleeve is made of a
material selected from the group consisting of Dacron.RTM. or
PTFE.
16. The apparatus of claim 12 wherein the sleeve is made of a woven
or braided material.
17. The apparatus of claim 12 wherein the sleeve is made of a
material selected from the group consisting of polyamides, nylon 6,
nylon 6,6, polyesters, PET, polyethers, fluorinated polymers,
polytetrafluoroethylene, biodegradable or nonbiodegradable fibers
derived from natural sources such as carbohydrates, collagens, and
proteins, and mixtures thereof.
18. The apparatus of claim 17 wherein the sleeve is
biodegradable.
19. The apparatus of claim 12 wherein: a) the hardening means
comprises at least one wire for insertion into and extension
through the introduction means into a peripheral conduit.
20. The apparatus of claim 19 wherein the wire is made of a
material selected from the group consisting of stainless steel,
spring steel, memory shape metals, and metal alloys.
21. The apparatus of claim 20 wherein the wire is made of
nitinol.
22. The apparatus of claim 20 wherein the wire is made of
titanium.
23. The apparatus of claim 12 wherein the peripheral conduit has an
inlet port and an exhaust port and wherein the hardening means is a
polymeric material.
24. The apparatus of claim 23 wherein the polymeric material is
introduced through the introduction means via an external
source.
25. The apparatus of claim 23 wherein the external source is a
syringe.
26. The apparatus of claim 23 wherein the external source is a
catheter.
27. The apparatus of claim 13 wherein the hardening means comprises
an activatable hardening material selected from the group
consisting of one-part polymer systems, two-part polymer systems
and self-expanding monomers.
28. The apparatus of claim 27 wherein the hardening means further
comprises a plurality of microspheres wherein the activatable
hardening material is carried, said microspheres being constructed
and arranged to release the activatable hardening material upon
disruption, thereby allowing the activatable hardening material to
harden.
29. The apparatus of claim 28 wherein the activatable hardening
material comprises a first component and a second component
isolated from each other by and carried in said microspheres, said
microspheres being constructed and arranged to release said first
and second components upon disruption, thereby allowing the
components to react and harden.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to the percutaneous treatment
of vessels by an apparatus and method wherein the apparatus is
delivered via catheter and comprises a surgical graft which is
fixated in a vessel by means of a chemical or mechanical
hardening-filler material system.
[0003] 2. General Background
[0004] Previous methods of treating aortic aneurysms include
treatment via surgical procedure in which an incision is made in
the abdomen or chest of the patient, the diseased area is cleaned
by the surgeon and an artificial graft is sutured in place. This
highly invasive procedure usually results in long hospital stays
and lengthy recoveries. Further, mortality and morbidity
complications often result as a consequence of this surgical
procedure.
[0005] Other percutaneous methods have been attempted, such as are
disclosed in U.S. Pat. No. 4,577,631 (utilizing occlusion catheters
with pressure sensitive adhesives), U.S. Pat. No. 4,740,207
(self-expanding stent-type materials) and U.S. Pat. Nos. 4,271,839,
4,776,337 and 4,762,132 (other stent derived devices).
[0006] There still exists a need, however, for a simple method of
repairing a vessel with an intravascular graft which allows normal
tissue ingrowth to occur at the repair site. There exists a
specific need for a percutaneous approach in which a catheter could
be loaded with a surgical graft that can be fixated in a vessel
such as the aorta.
SUMMARY OF THE INVENTION
[0007] The present invention provides devices for repairing aortic
aneurysms and the like. The intraluminal graft of the present
invention in one embodiment comprises a flexible linear or
bifurcated tubular sleeve delivered to a repair site in a body by
suitable means such as a catheter. The sleeve is suitably made of
woven or cast material, and has peripheral conduits or tubes at
each end. Each conduit has at least a single port that is connected
to an elongated introduction means associated with the catheter
delivery means. The introduction means may be attached to the outer
surface of the sleeve. The collapsed sleeve may be made rigid and
circular by the introduction through the introduction means of a
chemical or mechanical hardening means.
[0008] The chemical hardening means may be a polymeric material
introduced through the introduction means through an external
source, such as a catheter or syringe. Alternatively, the
mechanical hardening means may comprise a single wire or multiple
wires inserted into the conduits to support the ends, or any
portion of the sleeve. The wires are not attached to the sleeve but
reside in the conduits to provide a constant spring tension. The
wires may be of any suitable material which retains its tension,
such as spring wire or memory wire.
[0009] The introduction means may be detached from the sleeve after
introduction of the chemical or mechanical hardening means.
[0010] The sleeve may alternatively be associated with a fixation
means comprising either a series of cylindrical tubules or an
enclosure which fits over the sleeve, with a hardening-filler
system enclosed therein. The hardening-filler system includes an
activatable hardening material which may be provided in the form of
microspheres that upon external agitation may be disrupted,
allowing the contents to react together and form a hardened
material that fills the tubules or enclosure, thereby expanding and
rigidifying the fixation means, and fixing the sleeve in place in
the site of repair. Polymeric materials which are activatable
include thioisocyanates, aldehydes, isocyanates, divinyl compounds,
epoxides or acrylates. In addition to the aforementioned,
photoactivatable crosslinkable groups as succinimidyl azido
salicylate, succinimidyl-azidobenzoate, succinimidyl dithio
acetate, azidoiodobenzene, fluoro nitrophenylazide, salicylate
azides, benzophenone-maleimide, and the like may be used as
photoactivatable crosslinking reagents. The material may also
consist of a thin coating which can be activated by external forces
such as laser, radio frequency, ultrasound or the like, with the
same hardening result taking place. These materials would allow for
normal tissue ingrowth to take place.
BRIEF DESCRIPTION OF THE FIGURES
[0011] FIG. 1 shows a perspective view of a vascular graft
according to the present invention in a folded state prior to
placement and expansion thereof;
[0012] FIG. 2 shows a perspective view of the vascular graft in an
expanded state by means of wires;
[0013] FIG. 3 is a perspective view of the device as in FIG. 2
showing the introduction of chemical hardening material via
syringe;
[0014] FIG. 4 is a perspective view of an alternate embodiment
comprising a series of cylindrical tubules;
[0015] FIG. 5 is a perspective view of an alternative embodiment of
the device, where the vascular graft includes an enclosure which
fits over the sleeve;
[0016] FIG. 6 is an alternative embodiment of the present invention
having a fluid track comprising a continuous cylindrical tubule
which is helically wound around the proximal and distal ends of the
sleeve;
[0017] FIGS. 7a and 7b represent an alternative embodiment
comprising a bifurcated vascular graft including a dual guide wire
delivery system;
[0018] FIGS. 8a through 8d show placement of a bifurcated vascular
graft according to the present invention;
[0019] FIG. 9 shows a further alternative embodiment of a vascular
graft according to the present invention;
[0020] FIGS. 10a through 10c show filling of the cylindrical
tubules after placement of the graft;
[0021] FIGS. 11a through 11d are fragmentary views of vascular
grafts according to the present invention; and
[0022] FIGS. 12a and 12b are cross sectional views of a vascular
graft according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0023] The present invention provides a device and method for
repairing an aneurysm or the like in a vessel, such as the
aorta.
[0024] Referring to FIGS. 1 and 2, a vascular graft comprising a
sleeve is shown generally at 10. Sleeve 10 is shown in a folded
conformation in FIG. 1 and in an expanded state in FIG. 2. Sleeve
10 is either a flexible linear or bifurcated (as shown in FIGS.
7-12) tubular sleeve made of woven or extruded cast material.
Sleeve 10 is made of a biocompatible polymeric material. Fabrics
from which sleeve 10 may be made are polyamides, such as nylon 6,
nylon 6,6, and the like, Dacron.RTM., polyesters, such as PET,
polyethers, fluorinated polymers, such as polytetrafluoroethylene
(PTFE), or biodegradable or nonbiodegradable fibers derived from
natural sources such as carbohydrates, collagens, and proteins. The
fabric may be of a woven knit, or solid structure. The most
preferred materials are Dacron.RTM. and PTFE. Sleeve 10 is suitably
delivered by a catheter. Catheters of polyurethane, PTFE, PVC
silicone or the like with internal diameters of 1 to about 3 mm are
suitable for polymer injection.
[0025] Sleeve 10 has a proximal end 14, a distal end 16, an
interior portion 18, an exterior portion 20 and peripheral circular
conduits or tubes 22,24 located one at each end 14,16,
respectively. Each conduit 22,24 has at least one inlet port 26 and
at least one outlet or exhaust port 28, inlet(s) 26 being connected
to elongated introduction means 30,32 respectively. Introduction
means 30,32 may be attached to exterior portion 18 of sleeve 10.
Referring to FIG. 2, collapsed sleeve 10 is expanded and made rigid
by the insertion of a spring wire or wires 34,36 inserted through
introduction means 30,32. A single wire or multiple wires may be
inserted to support ends 14,16, the center body or any portion of
sleeve 10. Wires 34,36 are not attached to sleeve 10 but reside in
introduction means 30,32 or conduits 22,24, providing a constant
spring tension. The entrance tubing may be detached from the sleeve
after placement of supporting wires 34,36 in end tubes 22,24.
[0026] The supporting wire may be made of stainless steel, spring
steel, memory shape metals (such as nitinol, for example),
titanium, or metal alloys of any kind, not limited to the
aforementioned. Furthermore, the configuration of the supporting
wire may be solid, braided or woven.
[0027] As shown in FIG. 3, the graft may be expanded and made rigid
and circular by a chemical hardening means introduced into a single
spiral tube, or alternatively, as shown in FIG. 4, a series of
interconnected concentric cylindrical tubules 40 attached to and
encasing the sleeve 10. Tubules 40 are interconnected by means of
connecting tubes 41 extending between the tubules. The chemical
hardening means may be introduced in the form of an injectable
polymeric material comprised of a one part system, a two part
system, self expanding systems, thermosets, thermoplastics and the
like. These polymers or polymeric systems would fill tubes 32 or
tubules 40, causing them to expand and rigidify, thereby fixing the
sleeve at the site of repair. This embodiment is of particular use
for fusing such grafts in large vessels such as the aorta or
pulmonary arteries.
[0028] Two part activatable hardening material may be supplied in
the form of microspheres (not shown) that upon agitation by an
external force may be disrupted. The external energy could
originate from any suitable source including IR, visible or UV
light through optic fiber on mechanical vibrational means from
about 1 to 100,000 hertz supplied by mechanical or electrical
transducers or by heat upon disruption of the microspheres, the
activatable hardening material is liberated and allowed to harden.
Disruption of the microspheres releases the separated components,
allowing the components to react together and form a hardened
material that fills series of tubules 40 thereby fixing sleeve 10
in place at the site of repair. Polymeric systems may be comprised
of vinyl or divinyl compounds in which an initiator is contained in
the microspheres, epoxies containing microencapsulated amine
component, or diisocyanates with encapsulated amine or hydroxyl
terminated prepolymers. Amino groups can be so isolated from
methylacetimidate, ethyl acetimidate, dimethylglutarimidate,
dimethyl, adipidate, dimethyl sebaimidate, diisothionyl
propionimidate, dimethyl oxydipropionimidatesuccinate bis-esters,
disuccinimidyl tartarate, dicyanatobenzene, dichlorodinitrobenzene,
adipaldehyde, glutaraldehyde and the like.
[0029] These hardening-filler systems would allow for normal tissue
ingrowth in series of tubules 40 to take place. Because the tubules
comprise only a small fraction of the total surface area of the
sleeve, these hardening filling systems would allow for tissue
ingrowth to take place into the sleeve material not impeded by the
tubules, providing further reinforcement of the placement of the
sleeve 10.
[0030] In a further embodiment shown in FIG. 5, the material may be
introduced by means of a hardening-filler system comprising an
enclosure 50 attached to sleeve 10. Enclosure 50, like tubules 40,
is filled with an activatable hardening material consisting of
either a one-part polymer system, a two-part polymer system or a
self-expanding monomer, which upon polymerization would fill
enclosure 50, causing it to expand and rigidify, thereby fixing
sleeve 10 at the site of repair. The activatable hardening material
is described above with reference to FIG. 4.
[0031] Referring now to FIG. 6, an alternative embodiment of sleeve
10 is shown in place at a repair site 60. Sleeve 10 has a fluid
track comprising a continuous cylindrical tubule 40 which is
helically wound around proximal end 14 and distal end 16 of sleeve
10. Tubule 40 can be filled with a curing polymer selected from
thermoset polymers or two part polymers, as described hereinabove.
Sleeve 10 may optionally include supplemental physical attachment
means (not shown) such as spikes, barbs or the like at proximal and
distal ends 14,16.
[0032] FIGS. 7-9 represent an alternative embodiment comprising a
bifurcated vascular graft 110 including a dual guide wire delivery
system 112. Graft 110 has a proximal end 114 and at least two
distal ends 116,118. FIGS. 8a through 8d show placement of
bifurcated vascular graft 110 at a repair site 160 where the vessel
bifurcates. Graft 110 and delivery system 112 are advanced through
a vessel to repair site 160. Delivery system 112 includes guide
wires 120,122 whereby ends 114,116,118 are placed at different
branches of the vessel bifurcation. FIG. 7b shows graft 110 in
place at site 160.
[0033] FIGS. 9-12 show an alternative embodiment of a vascular
graft according to the present invention, indicated generally at
210. Graft 210 has proximal and distal ends 214,216 and cylindrical
tubule 240. Tubule 240 has a first end 242 and a second end 244,
located near proximal end 214. After placement of graft 210, tubule
240 is filled.
[0034] Referring to FIGS. 10a, 10b and 10c, filling means 250 is
shown. Although filling means 250 is shown in conjunction with a
tubular vascular graft, such a filling means may be used with any
vascular graft according to the present invention. Filling means
250 comprises casing 251, filling tube 252 with distal infusion
inlet 254 and exhaust tube 256 with distal exhaust vent 258.
Filling means 250 may be incorporated into the vascular graft
delivery means or may alternatively be separate from but associated
with the delivery means. FIG. 10b is an enlarged fragmentary view
of filling tube 252 which shows the manner in which infusion inlet
254 connects to first end 242 of tubule 240, via pinch ring 262
located near the distal end of infusion inlet 254. Distal end of
infusion inlet 254 is advanced into end 242 of tubule 240 until
pinch ring 262 is inserted in tubule 240. As shown in FIG. 10c,
casing 251 of filling means 250 is advanced over end 242 of tubule
240 whereby pinch ring 262 creates an interference fit between
filling tube 252 and end 242 of tubule 240. Exhaust vent 258
connects to end 244 of tubule 240 in the same manner.
[0035] FIGS. 11-12 show alternative embodiments of the inventive
vascular graft. FIG. 11a shows a graft 310 having an outer layer
370 surrounding tubules 340. FIG. 11b shows graft 310 having two
outer layers 370,372 surrounding tubules 340. FIG. 11c shows graft
410 having no outer layer over tubules 440, and lacking connection
between tubule 440 and proximal coil 480. FIG. 11d shows a cross
section of graft 510, having an inner core 590. FIGS. 12a and 12b
show a longitudinal cross section of graft 610 in place in repair
site 660, wherein graft 610 has an enlarged proximal coil 680
located directly at proximal end 614 of graft 610, i.e. not more
than about 5 mm from proximal end 614.
[0036] The unique features of the device are the manner of its
delivery and fixation at the site of repair, its low profile which
may prevent interference with normal heart functions, and the
non-invasive nature of the delivery which would reduce costs
normally associated with closure of such a defect. The device and
method of fixation provides a non-invasive treatment of aortic
aneurysms and the like. The device is made of polymeric material
and is delivered via catheter in a non-invasive procedure. In one
embodiment, the device operates through chemical means to repair an
aneurysm.
[0037] Advantages of the apparatus and method of the present
invention are many. No preformed stent is required and the
apparatus has a smaller insertion diameter than previous vascular
grafts. Further, the vascular graft has a lower cost of production
than previous graft materials and procedures.
[0038] The practice of the present invention achieves several
objectives and advantages. Currently, there are no percutaneous
devices available to cure a septal defect or the like. The device
and method of the present invention provides an advantage over
surgery in that the cost of the procedure is substantially less,
the risk of infection is less, the hospital residency time is less
and there is no physically deforming scar.
[0039] Further advantages include applicability to procedures such
as repair of PDA, patent ductus anomaly. The non-invasive mode of
delivery would reduce costs associated with this type of procedure.
In addition, the low profile of the apparatus may minimize or
prevent interference with normal heart functions.
[0040] While this invention may be embodied in many different
forms, there are described in detail herein specific preferred
embodiments of the invention. This description is an
exemplification of the principles of the invention and is not
intended to limit the invention to the particular embodiments
illustrated.
[0041] The above Examples and disclosure are intended to be
illustrative and not exhaustive. These examples and description
will suggest many variations and alternatives to one of ordinary
skill in this art. All these alternatives and variations are
intended to be included within the scope of the attached claims.
Those familiar with the art may recognize other equivalents to the
specific embodiments described herein which equivalents are also
intended to be encompassed by the claims attached hereto.
* * * * *