Source: http://www.google.com/patents/US8192482?dq=6,757,682
Timestamp: 2016-07-27 10:15:11
Document Index: 336154141

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

Patent US8192482 - Endoluminal stent - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA stent is provided comprising a plurality of hoops aligned along a common axis, wherein each of the hoops is oriented in a plane substantially perpendicular to the longitudinal axis of the stent. Each of the hoops includes a plurality of elongate elements joined to one another and forming apices that...http://www.google.com/patents/US8192482?utm_source=gb-gplus-sharePatent US8192482 - Endoluminal stentAdvanced Patent SearchPublication numberUS8192482 B2Publication typeGrantApplication numberUS 09/977,826Publication dateJun 5, 2012Filing dateOct 15, 2001Priority dateFeb 9, 1994Fee statusPaidAlso published asCA2182982A1, CA2182982C, CA2603004A1, CA2603004C, CA2604811A1, CA2604811C, DE29521548U1, DE29521776U1, DE29522113U1, DE29522160U1, DE29522161U1, DE29522162U1, DE69514511D1, DE69514511T2, DE69516292D1, DE69516292T2, DE69516293D1, DE69516293T2, DE69532892D1, DE69532892T2, EP0759729A1, EP0759729B1, EP0782841A2, EP0782841A3, EP0782841B1, EP0783873A2, EP0783873A3, EP0783873B1, EP0783874A2, EP0783874A3, EP0783874B1, EP1433438A2, EP1433438A3, US5609627, US5683450, US5693086, US5716365, US5718724, US5776180, US5800508, US5916263, US5938696, US6117167, US6302906, US20020019659, WO1995021592A1Publication number09977826, 977826, US 8192482 B2, US 8192482B2, US-B2-8192482, US8192482 B2, US8192482B2InventorsGeorge Goicoechea, John Hudson, Andrew H. Cragg, Claude Mialhe, Michael D. DakeOriginal AssigneeScimed Life Systems, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (252), Non-Patent Citations (28), Classifications (38), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetEndoluminal stent
US 8192482 B2Abstract
A stent is provided comprising a plurality of hoops aligned along a common axis, wherein each of the hoops is oriented in a plane substantially perpendicular to the longitudinal axis of the stent. Each of the hoops includes a plurality of elongate elements joined to one another and forming apices that point in a direction along the axis of the stent. The stent also comprises means for securing an apex of one hoop to a juxtaposed apex of a neighboring hoop.
a plurality of hoops aligned along a common axis, each of said hoops being non-helical and oriented in a plane substantially perpendicular to the longitudinal axis of the stent, and each of said hoops including a plurality of elongate elements joined to one another and forming apices that point in a direction along the longitudinal axis of the stent, and wherein at least one elongate element in each hoop is a continuation of an elongate element of an adjacent hoop; and
means for securing an apex of one hoop to an abutting a juxtaposed apex of a neighboring hoop.
2. A stent as recited in claim 1 comprising at least one stent segment in combination with one or more additional stent segments.
3. A stent as recited in claim 2 wherein said one or more additional segments are axially aligned with one another.
4. A stent as recited in claim 3 wherein said axially aligned segments are connected to one another by a tubular fabric element.
5. A stent as recited in claim 2 wherein said one or more additional segments are secured to one another by connecting means connecting at least some of the apices of hoops at mating ends of said stent and said additional segments.
6. A stent as recited in claim 2 wherein adjacent hoops are of the same diameter.
7. A stent as recited in claim 2 wherein adjacent hoops are of a different diameter.
8. A stent as recited in claim 2 wherein a first additional segment is axially parallel to, but non-common co-axial with, said stent segment.
9. A stent as recited in claim 8 further comprising a second additional segment axially parallel to said stent segment, but non-co-axial with either said stent segment or said first additional stent segment.
10. A stent as recited in claim 9 wherein at least one of said first and second additional stent segments is of frustoconical shape and is further combined with a third an additional stent segment, one end of which includes a mating frustoconical shape.
11. A stent as recited in claim 10, wherein said mating frustoconical stent segments are adapted to be separately placed in a bifurcated artery and then, by expansion of one of said frustoconical stent segments, secured to one another.
12. A stent as recited in claim 2 wherein at least one of said additional stent segments comprises:
a plurality of hoops aligned along a common axis, each of said hoops oriented in a plane substantially perpendicular to the longitudinal axis of the additional stent segment, and each of said hoops including a plurality of elongate elements joined to one another and forming apices that point in a direction along the longitudinal axis of the additional stent segment; and
means for securing an apex of one hoop to a juxtaposed apex of a neighboring hoop.
13. An endoluminal stent as claimed in claim 1 wherein said hoops are formed of a single continuous wire.
14. An endoluminal stent as claimed in claim 13 wherein said wire is nitinol.
15. An endoluminal stent as claimed in claim 1 wherein said securing means is a suture.
16. An endoluminal stent as claimed in claim 15 wherein said suture is a tied loop of thermoplastic material.
17. An endoluminal stent as claimed in claim 1 wherein said securing means is a staple.
18. An endoluminal stent as claimed in claim 1 wherein said securing means is wire twisted into loop.
19. An endoluminal stent as claimed in claim 18 wherein said wire is nitinol.
20. An endoluminal stent as claimed in claim 1 wherein said securing means is bead of thermoplastic material.
21. An endoluminal stent as claimed in claim 1 wherein each longitudinal end of the stent is substantially perpendicular square to the longitudinal axis of the stent.
22. An endoluminal stent as claimed in claim 1 wherein said stent is at least partially covered in fabric.
23. An endoluminal stent as claimed in claim 1 further comprising a radiopaque marker disposed on at least one end of the stent.
24. An endoluminal stent as claimed in claim 23 wherein said radiopaque marker comprises a radiopaque element attached to one end of said stent.
25. An endoluminal stent as claimed in claim 24 wherein said element is a platinum wire.
26. An endoluminal stent as claimed in claim 24 wherein said element is a gold wire.
27. An endoluminal stent as claimed in claim 23 wherein said radiopaque marker comprises a radiopaque tube disposed around a part of said stent.
28. An endoluminal stent as claimed in claim 27 wherein said tube is platinum.
29. An endoluminal stent as claimed in claim 27 wherein said tube is gold.
30. A stent comprising a tubular member having a plurality of hoops aligned adjacent one another along the longitudinal axis of said tubular member, each of said hoops comprising a plurality of elongate elements, with pairs of said elongate elements meeting one another and forming vertices axially pointing in a direction along the longitudinal axis of the stent, wherein at least some of said vertices axially abut and are individually connected to oppositely pointed vertices of elongate elements of an adjacent hoop, wherein the vertices of each hoop pointed in the axial direction lie in a common plane perpendicular to the longitudinal axis of the tubular member, and wherein at least one elongate element in each hoop is a continuation of an elongate element of an adjacent hoop.
31. A prosthesis for placement in a body lumen comprising a tubular graft supported and adapted to be retained in said lumen by a stent as recited in claim 30.
32. A method of reinforcing a body vessel using a tubular sheath disposed between an entry location in a body and an implantation location, said method comprising the steps of:
a. providing a stent as recited in claim 30;
e. withdrawing the sheath while holding the stent at the implantation location within the vessel and expanding the stent within the implantation location as the sheath is withdrawn by permitting the self-expandable stent, as the constraint of the sheath is removed to return to said expanded configuration;
33. A method according to claim 32, wherein said stent is comprised of a shape memory material.
34. A method according to claim 33, wherein said shape memory material is nitinol and step (b) is performed at low temperature.
35. A method according to claim 32, wherein at least one elongate element in each hoop is a continuation of an elongate element of an adjacent hoop.
This application is a continuation of Ser. No. 09/313,593, filed May 18, 1999, now U.S. Pat. No. 6,302,906, which is a continuation of Ser. No. 08/662,484, filed Jun. 13, 1996, now U.S. Pat. No. 5,916,263, which is a continuation 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. This application is also a continuation-in-part of Ser. No. 08/312,881.
The prior art stents and prostheses mentioned above are generally satisfactory for the treatment of aneurysms, stenoses and other angeological diseases at sites in continuous un-biurcated portions of arteries or veins.
In a particular aspect of the present invention there is provided a bifurcated intraluminal stent for use in juxtaposition with an angeological bifurcation; the bifurcated intraluminal stent comprising a proximal portion adapted to be positioned in service in a blood vessel in juxtaposition with a bifurcation, a first distal stent portion adapted to extend across the bifurcation into one of the branched blood vessels and a second distal stent portion adapted to allow blood to is flow from the proximal portion into the other branched vessel. The first distal stent portion may be formed integrally with the proximal portion.
Said nitinol wire may be type “M” nitinol wire which is martersitic 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.
In some embodiments the wire may have a helical configuration as disclosed in EP-A-0556850. Alternatively, the wire may be of an entirely novel configuration, namely one in which the wire forms a plurality of hoops such that the plane of the circumference of each hoop is substantially perpendicular to the longitudinal axis of the scent. Each hoop may comprise a substantially complete turn of the wire having a sinuous configuration; optionally, as each hoop is completed, the point of winding the wire may be displaced longitudinally with respect to the winding axis to form the next hoop. When the next hoop is complete, the point of winding is moved further longitudinally with respect to the winding axes to the form the next succeeding hoop and so on.
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”0 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.
The male engaging portion and female cooperating portion, of the first and second interengaging stents of this invention, may be formed separately from the remainder of the respective nonengaging portions of these stents and then the engaging and non-engaging portions secured to one another by securing means.
Any of the stents according to this invention may be provided on its external surface with circumferentially spaced wire barbs or hooks adapted to engage in the endoluminal surface of the host artery to resist longitudinal movement or slippage of the stent in use. Typically the barbs or hooks may be disposed on part of the stent which is provided with a fabric graft layer such that in use the points of the artery which are engaged by the barbs or hooks are covered by the fabric graft. It will be appreciated by a person skilled in the art that the trauma to the artery wall caused by the hooks or barbs may cause emboli; the provision of the fabric graft over the barbs or hacks in use will therefore help to prevent the introduction of such emboli into the blood stream.
This invention in another aspect provides a method for delivering a bifurcated endoluminal stent or prosthesis having a proximal portion and a first distal portion into the vasculature at an angeolagical bifurcation where a blood vessel branches into a first branched vessel and a second branched vessel. The method comprises inserting a first introducer containing the stent or prosthesis into the vasculature to a predetermined delivery location, the first introducer comprising an outer sheath, a proximal portion pusher, and a distal portion pusher; withdrawing the outer sheath of the first introducer while maintaining the proximal portion pusher in a fixed position until the proximal portion of the stent or prosthesis is deployed from the first introducer into the blood vessel; withdrawing the outer sheath and the proximal portion pusher while maintaining the distal portion pusher in a fixed position until the first distal portion of the stent or prosthesis is deployed from the first introducer at least partially into the first branched vessel; and withdrawing the first introducer from the vasculature.
In general, this invention provides a method of treating an angeological disease at a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel comprising the steps of disposing in the blood vessel a proximal portion of an endoluminal stent; directing blood flow from the blood vessel into the first branched vessel through a first distal portion of the endoluminal stent, the first distal portion being connected to the proximal portion and extending into the first branched vessel; and directing blood flow from the blood vessel into the second branched vessel through a second distal portion of the endoluminal stent, the second distal portion being connected to the proximal portion and extending into the second branched vessel. This method may be amplied to aneurysms, occlusions, or stenosis.
FIG. 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. 6 is a schematic view of another bifurcated endolurninal prosthesis in accordance with the present invention.
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 is 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 perpendiculaar to the longitudinal axis of the mandrel.
It will be apreciated that when the bifurcated prosthesis is positioned and re-expanded in the fitted position, blood can flow from the aortic artery into the proximal cart 12 of the prosthesis from where it can flow into the one common iliac artery through the frustoconical part 14 and the first distal part 16 and also into the other common iliac artery through the second frustoconical part 18.
The frustoconical proximal part 42 is constructed in the same way as the frustaconical parts 14, 18 of the bifurcated stent 10; the distal part 44 is constructed in the same way as the distal part 16 of the bifurcated stent 10. The distal end of the frustoconical proximal part 42 is secured to the proximal end of the distal part 44 by securing juxtaposed apices using polypropylene filaments as described above.
In another example of the present invention a bifurcated endoluminal prosthesis 50 as shown in FIG. 5 includes a bifurcated stent comprising a proximal portion 52 which tapers radially inwardly from its proximal end 54 to its distal end 56, and first and second transversly spaced frustoconical distal portions 58, 60 which are secured to the distal end 56 of the proximal portion 52; the proximal portion 52 is covered with a tubular graft layer of a biocompatible fabric 62.
One of said frastoconical intermediate portions 76 is secured at its distal end to an elongate distal portion go. The proximal end 82 of the proximal portion 72 is flared radially outwards towards its proximal end 82 to engage the intraluminal surface of the host blood vessel in service. Save for this flared portion, the entire endoprosthesis is covered with a fabric graft layer as shown in FIG. 6; said graft layer is carried externally of the wire skeleton and is folded over the distal extremity 84 of the other frustoconical intermediate portion 78 to form an internal lining in said other frustoconical immediate portion 78.
Said other frustoconical intermediate portion 78 constitutes a female cooperating portion in accordance with the present invention which is adapted to receive a male engaging portion of another prosthesis as indicated at 86 in FIG. 6. Said other prosthesis 86 includes a frustoconical proximal portion 88 which constitutes the is male engaging portion and an elongate distal portion 90. The whole of the other prosthesis 86 is covered with a fabric graft layer as shown in FIG. 6. In service, the male engaging portion 88 of the other prosthesis 86 is entered into and engaged with the female cooperating portion 78 of the bifurcated prosthesis 70 in situ in the manner herein before described. The fabric layer on the male engaging portion 88 butts face-to-face on the folded over portion of the fabric layer disposed internally of the female cooperating portion 78 to form a substantially blood-tight seal therewith.
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 20 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.
In an alternative embodiment illustrated in FIG. 9, seals 150, 151 may be disposed around the distal is 15 ends 160, 161 of outer sheath 10 and proximal portion pusher 102. Seals 150, 151 may be formed of silicone tubes.
In use, the prosthesis must first be loaded into introducer 100. Cuter sheath 101 is first removed from introducer 100. Balloon catheter 104 is then threaded through digital portion 16 and proximal portion 12 of the prosthesis. The prosthesis is then cooled to a temperature of approximately 10� C. or below and radially compressed. For this purpose, the prosthesis may be immersed in cold water. The prosthesis should preferrably remain in the water during the loading operation.
Outer sheath 101 is further withdrawn while maintaining proximal portion pusher 102 fixed until proximal portion 12 is fully deployed from the end of outer sheath 101, and the frustoconical portion 1 of the prosthesis just clears end 117, as shown in FIG. 14.
Balloon 107 is then deflated to allow blood to flow through proximal portion 12 and out frustoconical portion 16 of the prosthesis. Balloon 107 is withdrawn into the prosthesis until the distal end 118 of nose cone 106 is just above the proximal end of the prosthesis.
Balloon 107 is then inflated to seat the prosthesis, which may be provided with barbs (not shown) at its proximal end, against the wall of the aorta, as shown in FIG. 15.
Distal portion pusher 103 is then maintained in a fixed position while outer sheath 101 is withdrawn. Once outer sheath 101 has been withdrawn to the point at is which proximal end 117 of outer sheath 101 is flush with proximal end 115 of proximal portion pusher 102, both outer sheath 101 and proximal portion pusher 102 are withdrawn, still maintaining distal portion pusher 103 in a fixed position. Outer sheath 101 and proximal portion pusher 102 are withdrawn until distal portion 16 of the prosthesis is deployed clear of proximal end 116 of distal portion pusher 103 as shown in FIG. 16. Balloon 107 is slowly deflated to allow blood flow to be established through the proximal portion 12 of the prosthesis and out through frustoconical portion 18. Balloon 107 may be used to model distal portion 16 of the prosthesis as necessary by inflating balloon 107 where needed to expand distal portion 16. Balloon 107 is then deflated, and introducer 100 is withdrawn from the vasculature, leaving the guide wire 170 in place, as shown in FIG. 17.
FIG. 21( a) illustrates an exemplary second S 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.
Cuter sheath 301 may then be withdrawn while maintaining pusher 302 in a fixed position to fully deploy distal portion 44, as shown in FIG. 20. If necessary, balloon catheter 104 may be inserted through sheath 301 in order to model distal portion 44. Introducer 301 and guide wires 170, 171 are then removed from the vasculature and the entry points are closed.
In the case of an abdominal aortic aneurysm confined to the aorta and not extending far enough to affect the iliac arteries, a straight (i.e. nonbifurcated) stent may be used. Preferably, for such applications, the straight stent comprises a composite of at least two axially aligned stent segments. Two embodiments of such straight stents are described herein, each comprising axially aligned stent requests, each of the requests comprising one or more adjacent hoops, perpendicular to a common axis, and each hoop being formed of wire in a sinuous or zigzag configuration with some or all of the juxtaposed apices in adjacent hoops secured to one another.
The second embodiment of a straight stent that may be used according to this invention is illustrated in FIG. 23. Straight stent 450 includes stent portion 451, constructed of wire loops as described above with reference to stent portions 401 and 402. Stent portion 451 is partially covered by fabric 452. In this embodiment, fabric portion 4S1 covers and is supported by stent 451, whereas with stent 400, the fabric portion 403 is not supported by a stent.
In the aorta, introducer 490 is positioned and balloon 107 is inflated above the renal arteries in the same madder as described above in connection with the bifurcated stent and as illustrated in FIG. 31.
To treat an infrarenal occlusion, a canalization is first made through the thrombus by methods known in the art. A bifurcated endoluminal prosthesis according to the present invention is then implanted at the bifurcation site to provide an unobstructed lumen extending from the aorta into each of is the iliac arteries. Blood can thus flow freely from the aorta to the iliac arteries.
To implant the bifurcated endoluminal prosthesis to treat both types of occlusion, the delivery 5 system comprising introducer 100 discussed above for delivering the bifurcated endoluminal prosthesis to treat an abdominal aortic aneurysm is used. The same delivery method discussed above for implanting the bifurcated endoluminal prosthesis to treat abdominal aortic aneurysms is used to implant the device to treat the occlusion.
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White on Nov. 26, 1993.28Yoshioka et al., "Self-Expanding Endovascular Graft: An Experimental Study in Dogs," AJR 15: pp. 673-676 (1988).Classifications U.S. Classification623/1.16International ClassificationA61F2/00, A61M25/12, A61F2/90, A61F2/06, A61F2/82, A61F2/848, A61F2/07, A61F2/958, A61F2/954, A61M29/00Cooperative ClassificationA61M25/0662, A61F2240/001, A61F2210/0019, A61F2002/8486, A61F2002/075, A61F2002/061, A61F2/90, A61F2/07, A61F2250/0098, A61F2002/065, A61F2/958, A61F2/954, A61F2/82, A61F2/852, Y10S623/903, A61F2002/828, A61F2220/0075, A61F2220/0066, A61F2220/0033, A61F2220/0008, A61F2230/0067, A61F2220/0016European ClassificationA61F2/07, A61F2/82, A61F2/90, A61F2/954, 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: 20121227Sep 15, 2015IPRAia trial proceeding filed before the patent and appeal board: inter partes reviewFree format text: TRIAL NO: IPR2015-01722Opponent name: ENDOLOGIX, INC.Effective date: 20150812Dec 16, 2015FPAYFee paymentYear of fee payment: 4Dec 16, 2015SULPSurcharge for late paymentRotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services