Source: https://patents.justia.com/patent/6302906
Timestamp: 2020-03-28 12:18:59
Document Index: 263065592

Matched Legal Cases: ['art 12', 'arts 14', 'art 12', 'arts 14', 'arts 14', 'arts 14', 'arts 14', 'arts 14', 'arts 14', 'art 12', 'arts 14', 'art 12', 'artz\n5443498']

US Patent for System for delivering a prosthesis Patent (Patent # 6,302,906 issued October 16, 2001) - Justia Patents Search
Justia Patents Stent Combined With Surgical Delivery System (e.g., Surgical Tools, Delivery Sheath, Etc.)US Patent for System for delivering a prosthesis Patent (Patent # 6,302,906)
System for delivering a prosthesis
May 18, 1999 - Boston Scientific Technology, Inc.
Latest Boston Scientific Technology, Inc. Patents:
Intraluminal stent and graft
System and method for assembling an endoluminal prosthesis
This is a continuation of application Ser. No. 08/662,484, filed Jun. 13, 1996 now U.S. Pat. No 5,916,263, which is a continuation of application Ser. No. 08/317,763, filed Oct. 4, 1994 (now U.S. Pat. No. 5,609,627), which is a continuation-in-part of application Ser. No. 08/312,881, filed Sep. 27, 1994 (pending).
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; US-A-4886062 discloses that the stent can be delivered percutaneously and expanded in situ using a balloon catheter.
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 is heretofor been used.
FIG. 8(a) is a cross-sectional view of an is exemplary assembled introducer according to the present invention.
FIG. 8(g) is a cross-sectional view of part of the introducer of FIG. 8(f) taken along the line A—A.
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.
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.
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. 1a 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.
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. 1b 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.
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 104a. Guide wire conduit 104a 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 109a. Injection conduit 109a 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 109a, out injection orifice 109, and into the vasculature to monitor deployment of the prosthesis.
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 is 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”.
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.
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.
1. A system for delivering a prosthesis into the vasculature of a body in juxtaposition with an angeological bifurcation where a blood vessel branches into two branched vessels, said system comprising:
(a) a bifurcated endoluminal prosthesis having a proximal portion configured to be disposed in the blood vessel and two distal portions, at least one of said distal portions being configured to remain in the blood vessel without extending across the angeological bifurcation;
(b) an outer sheath configured to contain said bifurcated endoluminal prosthesis; and
(c) a pusher slideably disposed at least partially within said outer sheath and configured to contact an end portion of said bifurcated endoluminal prosthesis in pushing relation therewith.
2. A system as recited in claim 1 further comprising a balloon catheter disposed at least partially within said outer sheath and at least partially within said bifurcated endoluminal prosthesis.
3. A system as recited in claim 2 wherein said balloon catheter has a proximal end with a nose cone attached thereto.
4. A system as recited in claim 1 further comprising a homeostasis valve attached to said pusher.
5. A system as recited in claim 1 wherein one of said distal portions is configured to be disposed at least partially in one of the two branched vessels.
6. A system as recited in claim 1 wherein said pusher engages said end portion of said bifurcated endoluminal prosthesis.
7. A system for delivering a prosthesis into the vasculature of a body in juxtaposition with an angeological bifurcation where a blood vessel branches into two branched vessels, said system comprising:
(a) a bifurcated endoluminal prosthesis having a proximal portion adapted to be disposed in the blood vessel and a distal portion adapted to be disposed at least partially in one of the two branched vessels;
(c) a pusher slideably disposed at least partially within said outer sheath and adapted to contact an end portion of said bifurcated endoluminal prosthesis in pushing relation therewith.
8. A system as recited in claim 7 further comprising a balloon catheter disposed at least partially within said outer sheath and at least partially within said bifurcated endoluminal prosthesis.
9. A system as recited in claim 8 wherein said balloon catheter has a proximal end with a nose cone attached thereto.
10. A system as recited in claim 7 further comprising a hemostasis valve attached to said pusher.
11. A system for introducing endoluminal prostheses into a vessel to define a continuous lumen, said system comprising:
a first introducer for introducing a first prosthesis into the vessel, said first prosthesis having a portion adapted for connection to another prosthesis; and
a second introducer for (a) introducing a second prosthesis in a radially compressed state into the vessel and into said portion of said first prosthesis, and (b) deploying said second prosthesis to connect to said portion of said first prosthesis and to define said continuous lumen through said first prosthesis and said second prosthesis.
12. The system as recited in claim 11, said first introducer and said second introducer each comprising:
(a) an outer sheath configured to contain said first prosthesis and said second prosthesis, respectively; and
(b) a pusher slideably disposed at least partially within said outer sheath and adapted to contact an end portion of said first prosthesis and said second prosthesis in pushing relation therewith, respectively.
13. The system as recited in claim 11, said system being adapted for delivering said endoluminal prostheses into the vasculature of the body in juxtaposition with a bifurcation where a blood vessel branches into branched vessels, wherein said first introducer is configured to introduce said first prosthesis through one of said branched vessels, and wherein said second introducer is configured to introduce said second prosthesis through the other one of said branched vessels.
14. The system as recited in claim 13 wherein one of said endoluminal prostheses is a bifurcated prosthesis having a proximal portion adapted to be disposed in the blood vessel and a distal portion adapted to be disposed at least partially in one of the branched vessels.
15. The system as recited in claim 13 wherein one of said endoluminal prostheses is a bifurcated prosthesis having a proximal portion configured to be disposed in the blood vessel and two distal portions, at least one of said distal portions being configured to remain in the blood vessel without extending across the bifurcation.
16. The system as recited in claim 11 wherein at least one of said first prosthesis and said second prosthesis comprises a portion having a different radiopacity from said at least one of said first and second prosthesis, said portion having a radiographic image that is detectable using a detector outside the body.
17. The system as recited in claim 16 wherein said portion having said different radiopacity comprises at least one radiopaque marker.
18. The system as recited in claim 16 wherein said radiographic image of said portion differs depending on the rotational orientation of said at least one of said first and second prostheses so that said rotational orientation in the body lumen can be determined.
19. The system as recited in claim 18 wherein said portion having said different radiopacity is configured in a “V” shape.
20. The system as recited in claim 16 wherein said portion of said different radiopacity is positioned at an end portion of said at least one of said first and second prostheses to facilitate alignment within the body lumen.
21. The system as recited in claim 20 wherein each of said first and second prostheses comprises a portion having a different radiopacity.
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Patent number: 6302906
Date of Patent: Oct 16, 2001
Assignee: Boston Scientific Technology, Inc. (Maple Grove, MN)
Inventors: George Goicoechea (Freeport), Claude Mialhe (Draguignan), John Hudson (Glenfield), Andrew H. Cragg (Edina, MN), Michael D. Dake (Stanford, CA)
Attorney, Agent or Law Firm: Ratner and Prestia, PC
Application Number: 09/313,593
Current U.S. Class: Stent Combined With Surgical Delivery System (e.g., Surgical Tools, Delivery Sheath, Etc.) (623/1.11)