Source: http://www.google.com/patents/US7901449?dq=6,232,546
Timestamp: 2016-08-28 11:22:28
Document Index: 433601539

Matched Legal Cases: ['art 12', 'art 14', 'art 16', 'art 18', 'art 12', 'art 12', 'art 12', 'arts 14', 'art 12', 'arts 14', 'arts 14', 'arts 14', 'arts 14', 'arts 14', 'arts 14', 'art 12', 'arts 14', 'art 12', 'art 16', 'art 16', 'art 14', 'art 16', 'art 14', 'art 12', 'arts 14', 'art 16', 'arts 12', 'art 42', 'art 44', 'art 44', 'art 42', 'art 18', 'art 14', 'art 42', 'art 18', 'art 42', 'art 18', 'art 44', 'Application No. 97', 'Application No. 2007', 'Application No. 2004', 'Application No. 2006', 'Application No. 2006', 'Application No. 2', 'Application No. 2']

Patent US7901449 - Bifurcated endoluminal prosthesis - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsAn introducer for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method of treating and angeological disease using a bifurcated stent; an endoluminal stent having perpendicular...http://www.google.com/patents/US7901449?utm_source=gb-gplus-sharePatent US7901449 - Bifurcated endoluminal prosthesisAdvanced Patent SearchPublication numberUS7901449 B2Publication typeGrantApplication numberUS 11/879,685Publication dateMar 8, 2011Filing dateJul 18, 2007Priority dateFeb 9, 1994Fee statusPaidAlso published asUS6051020, US7510570, US7780720, US7942919, US20040073287, US20040098086, US20040098115, US20040106979, US20040167599, US20070265697Publication number11879685, 879685, US 7901449 B2, US 7901449B2, US-B2-7901449, US7901449 B2, US7901449B2InventorsGeorge Goicoechea, Claude Mialhe, John Hudson, Andrew H. Cragg, Michael D. DakeOriginal AssigneeScimed Life Systems, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (280), Non-Patent Citations (31), Referenced by (11), Classifications (40), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetBifurcated endoluminal prosthesis
US 7901449 B2Abstract
1. A prosthesis comprising:
a bifurcated base structure which defines a common flow lumen at a proximal end and at least two connector legs which define divergent flow lumens from the common flow lumen at a distal end and which define at least one female engaging portion at at least one of the distal ends of said at least two connector legs; and
a graft having a proximal end and a distal end which has a male engaging portion at said proximal end and which is adapted to be anchored within at least one of the female engaging portions of said at least two connector legs at the distal end of said bifurcated base structure, wherein engaging said male and female engaging portions provides a means for locking said graft and said bifurcated base structure together upon said graft being anchored in situ within said at least one female engaging portion to form a continuous extension of at least one of said divergent flow lumens of said bifurcated base structure.
2. The prosthesis as defined in claim 1, wherein said bifurcated base structure and said graft are formed of a thin biocompatible material.
3. The prosthesis of claim 1, wherein the graft is adapted to be anchored intravascularly within the one of the flow lumens of said bifurcated base structure.
4. A prosthesis comprising:
a bifurcated base graft structure which defines a common flow lumen at a proximal end and a pair of connector legs which define divergent flow lumens from the common flow lumen at a distal end and which define at least one male or female engaging portion at at least one of the distal ends of said pair of connector legs; and
a second graft structure having a proximal end and a distal end which has a reciprocal male or female engaging portion at said proximal end and which is adapted to overlap and be attached to one of said pair of connector legs at the distal end of said bifurcated base graft structure, wherein engaging said reciprocal male and female engaging portions provides a means for locking said second graft structure and said bifurcated base graft structure together upon said second graft structure being anchored in situ to form a continuous extension of at least one of said divergent flow lumens of said bifurcated base graft structure;
wherein at least one of the bifurcated base graft structure and the second graft structure comprises a first end and a second end, and wherein at least one of the first and the second ends is reinforced with a wire structure which has a plurality of apices extending beyond at least a portion of the corresponding end.
5. The prosthesis of claim 4 wherein the first and the second ends are each reinforced with a wire structure which has a plurality of apices extending beyond the first and the second ends.
6. The prosthesis of claim 4, wherein the second graft structure is adapted to be attached intravascularly to the one of the flow lumens of said bifurcated base graft structure.
7. A prosthesis comprising:
a bifurcated base graft structure which defines a common flow lumen at a proximal end and a pair of connector legs which define divergent flow lumens from the common flow lumen at a distal end and which define at least one male engaging portion at at least one of the distal ends of said at least two connector legs; and
a second graft structure having a proximal end and a distal end which has a female engaging portion at said proximal end and which is adapted to overlap and be attached to one of the male engaging portions of said pair of connector legs at the distal end of said bifurcated base graft structure, wherein engaging said male and female engaging portions provides a means for locking said second graft structure and said bifurcated base graft structure together upon said second graft structure being anchored in situ over said at least one male engaging portion to form a continuous extension of at least one of said divergent flow lumens of said bifurcated base graft structure.
8. The prosthesis of claim 7 wherein one of the bifurcated base graft structure and the second graft structure is reinforced by a metal wire structure.
9. The prosthesis of claim 8 wherein at least a portion of said metal wire structure is X-ray detectable.
10. The prosthesis of claim 8 wherein the metal wire structure comprises a plurality of wireforms.
11. The prosthesis of claim 10 wherein each wireform of the plurality of wireforms has a closed sinuous shape.
12. The prosthesis of claim 7
wherein each of the bifurcated base graft structure and the second graft structure comprises an inlet end and at least one outlet end;
wherein the prosthesis is adapted to be placed in a lumen of a first vessel that intersects with a second vessel such that at least one of the inlet end of the bifurcated base graft structure and the outlet end of the second graft structure is placed adjacent said intersection between the first vessel and the second vessel; and
wherein the at least one of the inlet end of the bifurcated based graft structure and the outlet end of the second graft structure is provided with a wire structure which has a plurality of apices extending beyond at least a portion of the corresponding inlet end of the bifurcated base graft structure and outlet end of the second graft structure.
13. The prosthesis of claim 7, wherein the second graft structure is adapted to be attached intravascularly to the one of the flow lumens of said bifurcated base graft structure.
14. A prosthesis comprising:
a second graft structure having a proximal end and a distal end which has a reciprocal male or female engaging portion at said proximal end and which is adapted to overlap and be attached to one of the of said pair of connector legs at the distal end of said bifurcated base graft structure, wherein engaging said reciprocal male and female engaging portions provides a means for locking said second graft structure and said bifurcated base graft structure together upon said second graft structure being anchored in situ to form a continuous extension of at least one of said divergent flow lumens of said bifurcated base graft structure;
wherein at least one of the bifurcated base graft structure and the second graft structure comprises a first end and a second end, and wherein at least one of the first and second ends is provided with a wire structure which has a plurality of apices extending beyond at least a portion of the corresponding end.
15. The prosthesis of claim 14, wherein the second graft structure is adapted to be attached intravascularly to the one of the flow lumens of said bifurcated base structure. Description
This application is a continuation application of application Ser. No. 10/692,886 filed Oct. 24, 2003, which is a continuation of Ser. No. 08/463,987, filed Jun. 5, 1995, now pending, which is a divisional of Ser. No. 08/317,763, filed Oct. 4, 1994, now U.S. Pat. No. 5,609,627, which is a continuation-in-part of Ser. No. 08/312,881, filed Sep. 27, 1994, now pending. The present application is also a continuation-in-part of Ser. No. 08/312,881.
The present invention related to a bifurcated endoluminal prosthesis for use in a bifurcated blood vessel such, for example, as the infrarenal portion of a mammalian aortic artery where it bifurcates to the common iliac arteries. The present invention also embraces a stent connecting means for connecting a stent (e.g. a stent which forms part of an endoluminal prosthesis) to another stent, as well as apparatus and method for introducing prostheses to the vasculature and methods of treating angeological diseases.
A stent is used to provide a prosthetic intraluminal wall e.g. in the case of a stenosis to provide an unobstructed conduit for blood in the area of the stenosis. An endoluminal prosthesis comprises a stent which carries a prosthetic graft layer of fabric and is used e.g. to treat an aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of embolism, or of the natural artery wall bursting. Typically, a stent or endoluminal prosthesis is implanted in a blood vessel at the site of a stenosis or aneurysm by so-called “minimally invasive techniques” in which the stent is compressed radially inwards and is delivered by a catheter to the site where it is required through the patient's skin or by a “cut down” technique in which the blood vessel concerned is exposed by minor surgical means. When the stent is positioned at the correct location, the catheter is withdrawn and the stent is caused or allowed to re-expand to a predetermined diameter in the vessel.
U.S. Pat. No. 4,886,062 discloses a vascular stent which comprises a length of sinuous or “zig-zag” wire formed into a helix; the helix defines a generally cylindrical wall which, in use, constitutes a prosthetic intraluminal wall. The sinuous configuration of the wire permits radial expansion and compression of the stent; U.S. Pat. No. 4,886,062 discloses that the stent can be delivered percutaneously and expanded in situ using a balloon catheter.
However, the prior art stents and prostheses are not wholly satisfactory for use where the site of desired application of the stent or prosthesis is juxtaposed or extends across a bifurcation in an artery or vein such, for example, as the bifurcation in the mammalian aortic artery into the common iliac arteries. For example, in the case of an abdominal aortic aneurysm (“AAA”) in the infrarenal portion of the aorta which extends into one of the common iliac arteries, the use of one of the prior art prosthesis referred to above across the bifurcation into the one iliac artery will result in obstruction of the proximal end of the other common iliac artery; by-pass surgery is therefore required to connect the one iliac artery in juxtaposition with the distal end of the prosthesis to the other blocked iliac artery. It will be appreciated by a person skilled in the art that it is desirable to avoid surgery wherever possible; the requirement for by-pass surgery associated with the use of the prior art prosthesis in juxtaposition with a bifurcation in an artery therefore constitutes a significant disadvantage.
Throughout this specification, the term “proximal” shall mean “nearest to the heart,” and the term “distal” shall mean “furthest from the heart.”
The first stent may then be delivered percutaneously or by a “cut down” technique to a site distal of the second stent such that the male engaging portion of the first stent in the radially compressed state is entered into the expanded female cooperating portion of the second stent; the catheter may then be withdrawn allowing the first stent to re-expand such that the male engaging portion engages in the female cooperating portion of the second stent.
Each of the first and second stents may comprise a sinuous wire formed into a tubular configuration. The sinuous and tubular configurations may be imparted to the wire by winding it on a mandrel. Typically, each stent may be made from a shape memory nitinol (nickel-titanium) wire which may be wound on to the mandrel to form the stent in a tubular configuration of slightly greater diameter than the diameter of the blood vessel in which the stent is intended to be used. The stent may be annealed at an elevated temperature and then allowed to cool in air so that the nitinol wire “remembers” the configuration in which it was wound on the mandrel.
Said nitinol wire may be type “M” nitinol wire which is martensitic at temperatures below about 13� C. and is austenitic at temperatures above about 25� C.; it will be appreciated therefore that the type “M” wire will be austenitic at body temperature of 37� C. Typically, the annealing may be conducted at about 500� C. or more for at least about 60 minutes; after cooling the wire may be immersed in cold water to facilitate removal of the wire from the mandrel with the wire in its maleable martensitic form. Typically, the cold water may have temperature of less than about 10� C.; the wire may be immersed for about 5 minutes or more. An advantage of using nitinol wire to form the stent in accordance with the present invention is that the nitinol wire is “super elastic” in its austenitic state; the radial outward force exerted by the stent on the wall of the blood vessel in use is therefore substantially constant irrespective of the diameter of the vessel and the expanded stent.
It will appreciated that an advantage of this novel arrangement is that the planes of the hoops are not skewed with respect to the longitudinal axis of the stent; the longitudinal ends of the stent are “square” to said longitudinal axis, so that when the stent is caused or allowed to expand in situ there is substantially no twisting of the stent as it shortens in length. It will be appreciated that this represents a significant advantage, as in areas of stenosis or aneurysm it is desirable to minimize the movement of the stent within the blood vessel so as to reduce the potential trauma to the patient. A stent of this configuration may be used, apart from the bifurcated embodiment otherwise taught herein, in any application which in stents generally have heretofor been used.
It will be appreciated by a person skilled in the art that the prostheses may be introduced to the site of use percutaneously or by “cut down” techniques.
In particular, the invention provides a bifurcated endoluminal prosthesis which can be positioned in an artery in juxtaposition with a bifurcation to extend into one of the branched arteries; the bifurcated prosthesis can be connected to another prosthesis which extends into the other branched artery. The prosthesis can be delivered percutaneously or by “cut down” methods and connected together in situ thereby to provide effective treatment of an angeological disease such, for example, as an aneurysm or a stenosis which extends across a bifurcation in a blood vessel without the need for by-pass surgery.
FIG. 1 a is a front view of a bifurcated intraluminal stent in accordance with the present invention constituting part of an endoluminal prosthesis.
FIG. 1 b is a front view of another stent which is adapted to be connected to the bifurcated stent of FIG. 1 a. FIG. 2( a) is a side view of part of the bifurcated stent of FIG. 1 a opened up to show its construction.
FIG. 2( b) is a side view of an exemplary mandrel used to form the part of the bifurcated stent shown in FIG. 2( a).
FIG. 3 is a side view of another part of the bifurcated stent of FIG. 1 a opened up to show its construction.
FIG. 4( a) is a side view of yet another part of the bifurcated stent of FIG. 1 a opened up to show its construction.
FIGS. 4( b)-4(f) are partial exploded views of the exemplary stent of FIG. 4( a) illustrating alternative means for securing juxtaposed apices according to the present invention.
FIG. 8( a) is a cross-sectional view of an exemplary assembled introducer according to the present invention.
FIGS. 8( b)-8(e) are side views of the component parts of the introducer of FIG. 8( a).
FIG. 8( f) is a partial cross-sectional view of the introducer of FIG. 8( a).
FIG. 8( g) is a cross-sectional view of part of the introducer of FIG. 8( f) taken along the line A-A.
FIGS. 10( a) and 10(b) are side views of other alternative embodiments of an introducer according to the present invention.
FIGS. 21( a)-21(c) are cross-sectional views of alternative insertion apparatus according to the present invention.
FIGS. 24( a), 24(b), 25, 26 and 27 are sequential cross-sectional views of the bifurcation of the abdominal aortic artery during introduction of an exemplary prosthesis according to the present invention.
The entire disclosure of U.S. patent application Ser. No. 08/463,987, filed Jun. 5, 1995 is expressly incorporated by reference herein.
A bifurcated stent in accordance with the present invention which is indicated at 10 in FIG. 1 a comprises a wire skeleton which is constructed in four separate parts, namely a proximal part 12, a first frustoconical part 14, a first distal part 16 and a second frustoconical part 18. Said bifurcated stent 10 carries a fabric graft layer (FIGS. 5, 6, and 7) for use as an endoluminal prosthesis e.g. in the infrarenal portion of a mammalian aorta in juxtaposition with the bifurcation of the common iliac arteries. It will be appreciated, however, that bifurcated stents (with or without fabric graft layers) for use in different parts of the angeological system and for different mammals can be constructed in accordance with the invention by varying the dimensions of the stent accordingly.
The construction of the exemplary proximal part 12 of the bifurcated stent 10 is shown in FIGS. 2( a) and 2(b); nitinol wire type M wire typically having a diameter of 0.46 mm (0.018″) is wound around mandrel 46 to form a plurality of hoops 20. The winding surface of mandrel 46 is provided with a plurality of upstanding pins 47 disposed in a zig-zag pattern for each of the hoops 20 so that in each hoop 20 the nitinol wire follows a sinuous path to define a plurality of circumferentially spaced apices 22. Each hoop 20 is wound onto mandrel 46 such that the plane of the circumference of each hoop 20 is substantially perpendicular to the longitudinal axis of the mandrel.
When one hoop 20 e.g. the hoop indicated at 20 a has been formed, the point of winding of the nitinol wire is displaced longitudinally with respect to the axis of mandrel 46 to form the next successive hoop 20 b. The stent shown in FIG. 2( a) is the stent formed on mandrel 46 shown in FIG. 2( b) after cutting the stent longitudinally and rotating it 45 degrees to show the construction of the stent.
The proximal part of the exemplary bifurcated stent of FIG. 1 a is formed on the mandrel with a diameter of about 24 mm and a length in the longitudinal direction of about 55 mm. From FIGS. 1( a), 2(a), and 2(b) it will be noted that the proximal part 12 is constituted by three hoops 20 of unit width at the proximal end 24 of the proximal part 12, two intermediate hoops 25 of twice unit width and, at its distal end 26, by a single hoop 20 of unit width. In the illustrated embodiment, intermediate hoops 25 have a plurality of offsets 25 a. Offsets 25 a are formed when the wire is passed around pins 47 on mandrel 46. Offsets 25 a add stability to the stent. When the nitinol wire has been wound onto mandrel 46, the nitinol wire is annealed at an elevated temperature and then allowed to cool.
In this embodiment of the invention the wire is annealed at a temperature of about 500� C. for 60 minutes and is then allowed to cool in air. The purpose of the annealing is so that the nitinol wire in its austenitic form “remembers” its configuration as wound on mandrel 46; it will be appreciated therefore that other temperatures and durations for the annealing are included within the present invention provided the nitinol wire “remembers” its wound configuration.
After annealing and cooling, the wire is immersed in cold water at less than 10� C. for about 5 minutes; the wire is then removed from the mandrel, and juxtaposed apices 22 of neighboring hoops 20 are secured together by securing means 99 (see FIG. 4( a)), which are, in this example, 0.003″ polypropylene filaments. Each apex 22 of each hoop 20 which has a juxtaposed apex of a neighboring hoop 20 is tied to the juxtaposed apex 22. It will be appreciated, however, that in other embodiments of the invention only some of the juxtaposed apices 22 may be secured in this way.
In addition to polypropylene filaments, the securing means may comprise a loop element 99 a of a suture material, for example, to tie the juxtaposed apices together, as shown in FIG. 4( b). The securing means may also comprise bead 99 b formed of a thermoplastic material around juxtaposed apices, as shown in FIG. 4( c). Also alternatively, the securing means may be a loop 99 c, ring 99 d, or staple 99 e formed of wire such as nitinol, as shown in FIGS. 4( d), 4(e), and 4(f) respectively.
The exemplary first and second frustoconical parts 14, 18 of the skeleton shown in the figures are formed in substantially the same way as the proximal part 12 by winding nitinol wire onto a mandrel and then annealing the wire before removing it from the mandrel. As shown in FIG. 3, the first and second frustoconical parts 14, 18 are each constituted by three hoops 20 of unit width. The mandrel is tapered such that the proximal end of each of the exemplary frustoconical parts 14, 18 is formed with a diameter of about 12 mm and the distal end 32 of each is formed with a diameter of about 9 mm. The overall length of each of the exemplary frustoconical parts 14, 18 is about 18 mm. The wire used for the frustoconical parts 14, 18 is nitinol type M wire having a diameter of 0.28 mm (0.011″). Juxtaposed apices 22 of each of the exemplary frustoconical parts 14, 18 are tied together using 0.03″ polypropylene filaments as described above. The first and second frustoconical parts 14, 18 are secured to the distal end 26 of the proximal part 12 of the stent 10 in transversely spaced relation as shown in FIG. 1 a by securing the apices 22 of the hoop 20 forming the wider proximal end 30 of each of the frustoconical parts 14, 18 to juxtaposed apices 22 of the hoop 20 on the distal end 26 of the proximal part 12.
The exemplary first distal part 16 of the bifurcated stent 10 is formed by winding nitinol type M wire typically having a diameter of 0.28 mm (0.011″) onto a mandrel to form twelve longitudinally spaced hoops 20 as shown in FIG. 4; the exemplary first distal part has an overall length of about 66 mm and a uniform diameter of about 9 mm. The proximal end 34 of the distal part 16 is secured to the narrower distal end 32 of the first frustoconical part 14 by tying each apex 22 on the proximal end 34 of the first distal part 16 to a juxtaposed apex on the distal end 32 of the first frustoconical part 14 using, in this embodiment, 0.003″ polypropylene filaments.
The proximal part 12, the first and second frustoconical parts 14, 18, and the first distal part 16 are each covered with a tubular graft layer of a biocompatible woven fabric (FIGS. 5, 6, and 7) such, for example, as a plain woven fabric made from 30 or 40 denier polyester. The tubular fabric layers may be attached to the proximal and distal parts 12, 16 of the stent 10 by stitching with, for example, 0.003″ polypropylene filaments around the apices 22 of the underlying skeleton. The fabric covered stent constitutes one form of an endoluminal prosthesis.
The sinuous configuration of each turn 20 of the wire skeleton of the stent 10 allows the prosthesis to be compressed resiliently radially inwards so that it can be received in a catheter e.g. a 16 or 18 French catheter for percutaneous or cut down delivery, e.g. to an intraluminal site in the infrarenal section of the aortic artery. Larger diameter catheters up to, e.g., 20 French, may be used to deliver the prosthesis using “cut down” procedures.
An x-ray opaque marker may be attached to one or more ends of a stent so that the delivery of the stent can be monitored using x-rays. As shown in FIG. 4( a), such a radiopaque marker may typically comprise a gold or platinum wire 17 crimped onto an end of stent 16. Alternatively, the radiopaque marker may be a tube 17 a disposed around a length of wire on the stent, also as shown in FIG. 4( a). Typically, in the bifurcated stent the marker is secured to the stent in line with the distal stent portion so that the distal stent portion can be aligned with and inserted into one of the branched arteries in situ.
In cases where it is required to implant a prosthesis in the other common iliac artery a second prosthesis comprising a second stent 40 as shown in FIG. 1 b can be used. The second stent 40 includes a wire skeleton comprising a proximal frustoconical part 42 and a distal part 44. The distal part 44 of the second stent 40 also may be covered with a tubular graft layer of a biocompatible fabric such, for example, as polyester or polytetrafluoroethylene fabric (FIGS. 5, 6, and 7).
In use, the second prosthesis is compressed radially inwards and is received in a catheter for percutaneous or “cut down” delivery to the other common iliac artery. The frustoconical proximal part 42 is guided, in the radially compressed state, into the second frustoconical part 18 of the bifurcated stent 10. The catheter is then withdrawn allowing the second stent 40 to re-expand towards its remembered configuration, until the distal part 14 engages the endoluminal surface of the other common iliac artery, and the outer surface of the frustoconical proximal part 42 engages the interior surface of the second frustoconical part 18 of the bifurcated stent 10.
As with other stents described herein, the frustoconical proximal part 42 may be formed with circumferentially spaced barbs or hooks 43, as shown in FIG. 1 b, which engage in the wire skeleton of the second frustoconical part 18 of the bifurcated stent 10. When barbs 43 are on proximal portion 12, they engage the inner wall of the artery.
In use the prosthesis is delivered percutaneously or by “cut down” methods to an artery in juxtaposition with an arterial bifurcation; blood can flow through the frustoconical proximal portion 52 into each of the branched arteries through the first and second distal frustoconical portions 58, 60. If a prosthesis is required in one or both of the branched arteries, a separate prosthesis comprising a stent of the type shown in FIG. 1 b referred to above covered with fabric can be connected to the bifurcated prosthesis 50 by inserting and re-expanding the proximal end of such a separate prosthesis in one or both of the distal frustoconical portions 58, 60 of the prosthesis 50 for engagement therein.
Yet another example of the present invention is shown in FIG. 7 in which a bifurcated endoluminal prosthesis 91 has a generally cylindrical proximal portion 92; said proximal portion 92 is connected at its distal end 93 to an elongate, generally cylindrical distal portion 94. Said proximal portion 92 is also connected at its distal end 93 to a generally cylindrical intermediate portion 95 which is secured in transversely spaced relation to the elongate distal portion 94. Said cylindrical intermediate portion 95 constitutes a female engaging portion which is adapted to receive a generally cylindrical male-engaging portion of a second elongate prosthesis (not shown). The male engaging portion is equipped with circumferentially spaced external barbs to engage in the female cooperating portion in service. As shown in FIG. 7, the whole of the bifurcated prosthesis 91 is covered with an external fabric graft layer save for a flared portion 96 towards the proximal end 97 of the proximal portion 92.
Referring to FIGS. 8( a)-8(f), an exemplary embodiment of a delivery system according to the present invention will be described. This system is used to deploy the bifurcated stent 10 when it is covered with a fabric graft layer to create an endoluminal prosthesis. Introducer 100 includes outer sheath 101. Outer sheath 101 is a cylindrical tube adapted to be inserted either percutaneously or by “cut-down” procedures into the vasculature from an entry point to the bifurcation site where the prosthesis is to be deployed.
As shown in FIG. 8( g), which is a cross-sectional view of balloon catheter 104 in the direction A-A of FIG. 8( f), balloon catheter 104 has a guide wire conduit 104 a. Guide wire conduit 104 a extends throughout the length of balloon catheter 104 for passing a guide wire (not shown) through introducer 100. In the illustrated embodiment, balloon catheter 104 also includes injection orifice 109 and an injection conduit 109 a. Injection conduit 109 a connects injection orifice 109 to an injection site 108 at or near the distal end of balloon catheter 104 as shown in FIG. 8( e). Radiopaque liquid may be injected into injection site 108, through injection conduit 109 a, out injection orifice 109, and into the vasculature to monitor deployment of the prosthesis.
Also in the illustrated embodiment of FIGS. 8( f) and 8(g), balloon catheter 104 has an inflation orifice 110 located at a point where balloon 107 is attached to balloon catheter 104. A balloon inflation conduit 110 a connects balloon inflation orifice 110 to balloon inflation site 111 (FIG. 8( e)). Balloon 107 may be inflated and deflated from balloon inflation site 111 during delivery of the prosthesis.
FIG. 10( a) shows an alternative embodiment of introducer 100. As shown in FIG. 10( a), wings 112 and 113 are provided at the distal end of introducer 100. Wing 112 is connected to proximal portion pusher 102, and wing 113 is connected to outer sheath 101. Wings 112 and 113 indicate the rotational orientation of proximal portion pusher 102 and outer sheath 101, respectively. This in turn indicates the orientation of proximal portion 12 within outer sheath 101 and distal portion 16 within proximal portion pusher 102. Wings 112 and 113 in the illustrated embodiment are also provided with holes 112 a and 113 a. As shown in FIG. 10( b), a rod 128 or other fixation device may be attached to wings 112 and 113 using e.g. bolts through holes 112 a and 113 a secured by wing nuts 129 or other securing means. Rod 128 prevents relative movement of proximal portion pusher 102 and outer sheath 101. Wings may also be provided on distal portion pusher 103 and used to secure distal portion pusher 103 to either proximal portion pusher 102 or outer sheath 101 using a fixation device as described above.
Also shown in FIG. 10( a) as part of introducer 100 is hemostasis valve 114. Hemostasis valve 114 is connected to distal portion pusher 103 and acts as a simple seal around balloon catheter 104. Although it prevents fluid loss, hemostasis valve 114 allows balloon catheter 104 to slide within distal portion pusher 103. Alternatively, a Touhy-Borst valve (not shown) may be used instead of hemostasis valve 114. The Touhy-Borst valve is a device that may be manually tightened over balloon catheter 104. Lightly tightening such a valve permits balloon catheter 104 to slide; firmly tightening such a valve clamps balloon catheter 104 in place.
Referring again to FIG. 8( f), the prosthesis is inserted such that the outer surface of proximal portion 12 contacts and is radially restrained by outer sheath 101, and the outer surface of distal portion 16 contacts and is radially restrained by proximal portion pusher 102. End 115 of proximal portion pusher 102 longitudinally engages proximal portion 12 of the prosthesis as shown in FIG. 8( f).
Referring to FIG. 11, introducer 100 is passed through an entry point (not shown) either in the patient's skin (percutaneous operation) or into the vasculature itself which has been surgically exposed (“cut-down” operation). Introducer 100 is inserted over a guide wire 170 into the vasculature from the entry point to the desired delivery location at an angeological bifurcation.
While maintaining proximal portion pusher 102 in a fixed position, outer sheath 101 is withdrawn until the proximal end of the prosthesis emerges from outer sheath 101 as shown in FIG. 13. Using a radiopaque marker 120 disposed on proximal end of the prosthesis, the introducer is rotated until proper alignment of the prosthesis is obtained. In the illustrated embodiment, radiopaque marker 120 is a platinum wire twisted around an apex of the prosthesis in a “V” shape. To ensure proper alignment, the stent should be rotated until only the profile of the V is seen and shows up as a straight line rather than a “V”.
FIG. 21( a) illustrates an exemplary second introducer 300 used for deploying second distal part 44. Second introducer 300 of the illustrated embodiment comprises cylindrical outer sheath 301 and female Luer lock assembly 310. Second introducer 300 also has hemostasis valve 361 contained within a hub 362 thereof. Cartridge 311 shown in FIG. 21( b) is adapted to be attached to second introducer 300. Cartridge 311 has threaded male Luer lock assembly 312 provided on its proximal end. Cartridge 311 has outer tube 313 which houses inner tube 314.
A guide wire 171 is then inserted into the vasculature to the bifurcation site and through distal stent portion 12 as shown in FIG. 18. A dialator 359 (FIG. 21( c)) having an outer diameter slightly less than the inner diameter of second introducer 300 is then inserted into second introducer 300 such that tapered end 360 extends out end 320 of second introducer 300. End 360 of dialator 359 has a hole therein that is just slightly larger than guide wire 171 and tapers gradually outward from the hole to the outer diameter of dialator 359.
To treat an abdominal aortic aneurysm that does not extend down over the walls of the iliac arteries, as shown in FIG. 24( a), straight stent 400 (or 450) is disposed as illustrated in FIG. 26. Proximal stent portion 401 engages the inner walls of the aorta above the aneurysm. Distal stent portion 402 engages the inner wall of the aorta below the aneurysm. Intermediate fabric portion 403 extends across the aneurysm, providing a strong, stable lumen for blood flow through the aorta.
Introducer 410 is passed through an entry point (not shown) over guide wire 411 as shown in FIG. 24( a). This insertion may be accomplished using percutaneous or cut-down techniques. Introducer 410 is then inserted to the desired delivery location.
In the aorta, introducer 410 is positioned and balloon 107 is inflated above the renal arteries in the same manner as described above in connection with the bifurcated stent and as illustrated in FIG. 24( a).
While maintaining proximal portion pusher 102 in a fixed position, outer sheath 101 is withdrawn until proximal portion 401 of stent 400 emerges from outer sheath 101 as shown in FIG. 24( b). Using a radiopaque marker 420 disposed on the proximal end of the proximal portion 401, stent 400 is optimally aligned within the aorta. Outer sheath 101 is further withdrawn until proximal portion 401 emerges therefrom, as shown in FIG. 25. Outer sheath 101 is then further withdrawn until it is flush with proximal portion pusher 102. Then both outer sheath 101 and proximal portion pusher 102 are withdrawn while maintaining distal portion pusher 103 in a fixed position. Distal portion 402 is thus deployed from the end of outer sheath 101, as shown in FIG. 26.
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White on Nov. 26, 1993.31Yoshioka et al., "Self-Expanding Endovascular Graft: An Experimental Study in Dogs," AJR 15: pp. 673-676 (1988).Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8388679Mar 5, 2013Maquet Cardiovascular LlcSingle continuous piece prosthetic tubular aortic conduit and method for manufacturing the sameUS8419788Jul 13, 2012Apr 16, 2013Idev Technologies, Inc.Secured strand end devicesUS8696741Dec 23, 2010Apr 15, 2014Maquet Cardiovascular LlcWoven prosthesis and method for manufacturing the sameUS8739382Jul 13, 2012Jun 3, 2014Idev Technologies, Inc.Secured strand end devicesUS8966733May 28, 2014Mar 3, 2015Idev Technologies, Inc.Secured strand end devicesUS8974516Dec 17, 2013Mar 10, 2015Board Of Regents, The University Of Texas SystemPlain woven stentsUS9023095May 27, 2011May 5, 2015Idev Technologies, Inc.Stent delivery system with pusher assemblyUS9149374Apr 23, 2014Oct 6, 2015Idev Technologies, Inc.Methods for manufacturing secured strand end devicesUS9402753Dec 22, 2011Aug 2, 2016Maquet Cardiovascular LlcWoven prosthesis and method for manufacturing the sameUS9408729Jan 20, 2015Aug 9, 2016Idev Technologies, Inc.Secured strand end devicesUS9408730Jan 19, 2016Aug 9, 2016Idev Technologies, Inc.Secured strand end devicesClassifications U.S. Classification623/1.35, 623/1.13International ClassificationA61F2/00, A61M25/12, A61F2/82, A61F2/06, A61F2/90, A61F2/954, A61F2/958, A61F2/07, A61F2/848, A61M29/00Cooperative ClassificationY10T29/49826, Y10S623/903, A61F2002/075, A61F2250/0098, A61F2002/828, A61F2002/061, A61F2/954, A61F2/958, A61F2/82, A61F2240/001, A61F2002/8486, A61F2/07, A61F2/90, A61F2/852, A61F2210/0019, A61F2002/065, A61F2220/0075, A61F2220/0033, A61F2220/0066, A61M25/0662, A61F2230/0067, A61F2220/0008, A61F2220/0016European ClassificationA61F2/90, A61F2/82, A61F2/954, A61F2/07, A61F2/958Legal EventsDateCodeEventDescriptionMar 8, 2013ASAssignmentOwner name: ACACIA RESEARCH GROUP LLC, TEXASFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BOSTON SCIENTIFIC SCIMED, INC.;REEL/FRAME:029940/0514Effective date: 20121220Mar 14, 2013ASAssignmentOwner name: LIFEPORT SCIENCES LLC, TEXASFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ACACIA RESEARCH GROUP LLC;REEL/FRAME:030003/0055Effective date: 20121227Aug 13, 2014FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services