Bag for use in the intravascular treatment of saccular aneurysms

• US 6,346,117 B1
• Filed: 03/02/2000
• Issued: 02/12/2002
• Est. Priority Date: 03/02/2000
• Status: Expired due to Fees

• Current Assignee: Prodesco, Inc. (Compagnie Generale DES Etablissements Michelin SCA)
• Original Assignee: Prodesco, Inc. (Compagnie Generale DES Etablissements Michelin SCA)
• Inventors: Greenhalgh, E. Skott
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/517,273
• Time in Patent Office: 712 Days
• Field of Search: 606/151, 606/113, 606/114, 606/127, 606/213, 606/157, 606/200, 606/108, 606/1
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

A bag for use in the intravascular treatment of saccular aneurysms and a method of forming the bag are disclosed. The bag is formed from a plurality of flexible, resilient filamentary members braided into a tubular sleeve and biased into a first shape having an expanded first diameter sized to substantially fill the aneurysm. The bag is resiliently deformable into a second shape having a diameter smaller than the first and sized to slidingly interfit within the lumen of a catheter. An opening is provided in the bag to receive a clotting medium, such as a platinum wire, on which blood clots can be induced to form by mechanical or electrolytic means. A closure is provided by biasing the filamentary members to form a constriction around the opening. In use the, bag is inserted into a saccular aneurysm via the catheter and expands to its first diameter upon release therefrom. Interstices between the interbraided filamentary members provide pores allowing blood from the aneurysm to enter the bag when the bag is positioned within the aneurysm. The clotting medium wire is packed into the bag, blood clots on the wire and occludes the aneurysm, sealing it off from the blood stream and preventing rupture. The wire is released from the catheter and is contained within the bag in the aneurysm.

Claims

1. A flexible bag adapted to pass through a catheter lumen and expand to substantially occupy a fluid-filled cavity larger than said lumen, said bag being adapted to receive fluid within said cavity and a clotting medium for contact with said fluid, said bag comprising:

a plurality of interlaced flexible filamentary members;

a multiplicity of pores formed by interstices between said filamentary members, said pores being sized to allow said fluid to enter said bag but preventing outward extension of said clotting medium, said filamentary members being resiliently biased to assume an expanded first diameter substantially filling said cavity upon release from said catheter lumen, said filamentary members being resiliently deformable to a second diameter smaller than said first diameter and sized to slidingly interfit within said catheter lumen.

2. A flexible bag according to claim 1, wherein said clotting medium comprises a length of wire.

3. A flexible bag according to claim 2, wherein said length of wire is electrically conductive.

4. A flexible bag according to claim 2, further comprising an opening for receiving said length of wire into said bag, said filamentary members adjacent to said opening being resiliently biased to form a constriction in said bag closing off said opening and preventing an end of said length of wire from extending outwardly therethrough, said filamentary members being resiliently deformable away from said opening to expand said constriction and allow access to said bag through said opening.

5. A flexible bag according to claim 4, wherein said filamentary members are interlaced by braiding.

6. A flexible bag according to claim 5, wherein said filamentary members are multifilament polymer yarns.

7. A flexible bag according to claim 6, wherein said yarns are polyester.

8. A flexible bag according to claim 5, wherein said bag comprises an elongated tube, said opening being formed at an end of said elongated tube, said filamentary members adjacent to said open end being biased radially inwardly to form said constriction closing off said opening.

9. A flexible bag according to claim 8, further comprising a continuous flexible stent disposed within said bag, said stent being resiliently biased to conform to a tubular shape having a diameter substantially equal to said first diameter, said stent pushing radially outwardly to support said bag when expanded to said first diameter, said stent being resiliently deformable into a collapsed shape sized to slidingly interfit within said catheter lumen, biasing forces within said stent expanding said stent to said tubular shape upon release of said stent and said bag from said catheter lumen.

10. A flexible bag according to claim 9, wherein said stent comprises a resilient, flexible wire biased along a helical path conforming to said tubular shape.

11. A flexible bag according to claim 8, further comprising a plurality of supplemental, resilient filaments contiguous with said filamentary members, said supplemental filaments being biased to conform to a tubular shape having a diameter substantially equal to said first diameter, said supplemental filaments pushing radially outwardly to augment the support of said bag when expanded to said first diameter, said supplemental, resilient filaments being deformable into a collapsed shape sized to slidingly interfit within said catheter lumen, biasing forces within said filaments expanding said bag to said tubular shape upon release of said bag from said catheter lumen.

12. A flexible bag according to claims 11, wherein said supplemental filaments are interbraided with said filamentary members.

13. A flexible bag according to claim 11, wherein said supplemental filaments are positioned interiorly of said bag.

14. A flexible bag according to claim 11, wherein said supplemental filaments are radiopaque monofilament wires.

15. A flexible bag according to claim 14, wherein said supplemental filaments are made of nitinol.

16. A flexible bag defining an enclosed space, said bag being adapted to pass through a catheter lumen for insertion into a blood-filled saccular vascular aneurysm, said bag being porous to allow for the passage of blood within the aneurysm and containing a length of wire in contact with said blood for promoting clotting, clotted blood substantially filling said enclosed space and sealing off said aneurysm, said bag comprising:

a plurality of interlaced flexible filamentary members surrounding said enclosed space, said filamentary members being resiliently biased to assume a first shape state wherein said bag is expanded to a first diameter sized to substantially fill said aneurysm, said filamentary members being resiliently deformable to a second shape state wherein said bag is collapsed to a second diameter smaller than said first diameter and sized to slidingly interfit within said catheter lumen, said resilient biasing of said filamentary members expanding said bag to said first diameter upon release from said catheter lumen into said aneurysm;

an opening in said bag for receiving said length of wire into said enclosed space, said filamentary members having end portions biased to form a constriction in said bag closing off said opening and preventing said wire from extending outwardly therefrom, said end portions being resiliently deformable away from said opening to expand said constriction and allow access to said enclosed space through said opening.

17. A flexible bag according to claim 16, wherein said filamentary members are interlaced by braiding.

18. A flexible bag according to claim 16, having a porosity between about 50% and 80%.

19. A flexible bag according to claim 18, wherein said filamentary members comprise monofilament yarns having a denier between about 5 and 100.

20. A flexible bag according to claim 19, wherein said filamentary members are made of polyester.

21. A flexible bag according to claim 16 further comprising a catheter having a lumen, said bag being in said second shape state and positioned within said lumen, said bag being slidable through said lumen for insertion into said saccular aneurysm.

22. A method of forming a flexible bag defining an enclosed space and adapted to fit within a catheter lumen and expand to substantially occupy a blood-filled saccular vascular aneurysm, said enclosed space adapted to receive said blood and a clotting medium for promoting clotting, said method comprising the steps of:

braiding a plurality of flexible resilient filamentary members into a resiliently deformable tube of predetermined length and predetermined first diameter sized to substantially fill said aneurysm, said tube having open ends oppositely arranged;

biasing said filamentary members into a first shape state substantially maintaining said tube in a radially expanded shape at said first diameter, said filamentary members being resiliently deformable into a second shape state wherein said tube is collapsed to a second diameter smaller than said first and sized to slidingly interfit within said catheter lumen;

biasing said filamentary members radially inwardly at said ends to form constrictions substantially closing off said ends, said filamentary members being resiliently deformable radially outwardly of said tube providing an opening for access to said enclosed space for receiving said clotting medium therein.

23. A method of forming a flexible bag according to claim 22, wherein said braiding step is performed over a mandrel having a bulbous shape.

24. A method of forming a flexible bag according to claim 23, wherein said biasing steps are performed by applying heat to said filaments while said filaments are on said mandrel.

25. A method of forming a flexible bag according to claim 22, further comprising the steps of:

interbraiding a plurality of radiopaque monofilament wires with said filamentary members forming said tube;

biasing said wires into said first shape state, said wires being resiliently deformable into said second shape state;

said wires being resiliently collapsible to said second diameter and interfitting within said catheter lumen, said wires pushing radially outwardly to support said bag when expanded to said first diameter upon release from said catheter.

26. A method of forming a flexible bag according to claim 22, further comprising the step of positioning said bag within the lumen of a catheter, said bag being collapsed to said second diameter to slidingly interfit within said lumen.