Method and apparatus for occluding vessels

• US 5,382,261 A
• Filed: 09/01/1992
• Issued: 01/17/1995
• Est. Priority Date: 09/01/1992
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Expandable Grafts Partnership
• Inventors: Palmaz, Julio C.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US07/938,816
• Time in Patent Office: 868 Days
• Field of Search: 606/194-200, 606/157, 606/158, 623/1, 623/11, 623/12, 623/2, 623/3, 138/93, 600/36
• US Class Current: 606/158
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector

Abstract

A vessel occluder for providing permanent occlusion of a vessel in a person utilizes a flexible closure member attached to at least one metallic radially expandable, generally tubular shaped stent, the flexible closure member having a generally tubular shaped cross-sectional configuration.

Claims

1. A vessel occluder for providing permanent occlusion of a vessel in a person, the vessel having an inner wall surface and having a body fluid flowing therethrough, comprising:

at least one metallic tubular shaped member, having an outer surface, an interior and first and second open ends, the tubular shaped member having a first diameter which permits intraluminal delivery of the at least one tubular shaped member into the vessel to be occluded;

a flexible closure member, attached to the first open end of the at least one tubular member, which seals the first open end, the closure member having a first diameter, which is substantially the same as the at least one tubular shaped member first diameter; and

the at least one tubular shaped member and at least a portion of the flexible closure member having a second expanded permanent diameter, upon the application from the interior of the tubular shaped member of a radially outwardly extending force, which second diameter is variable and controlled by an amount of force applied to the tubular shaped member, which force deforms at least a portion of the at least one tubular shaped member to permanently retain the at least one tubular shaped member and the portion of the closure member with the second expanded permanently diameter, whereby the closure member is disposed in sealing engagement with the inner wall surface of the vessel and occludes the vessel to prevent the body fluid from flowing past the closure member.

2. The vessel occluder of claim 1, wherein the flexible closure member is formed of a bio-compatible material which is disposed over at least a portion of the at least one tubular shaped member.

3. The vessel occluder of claim 2, wherein the flexible closure member is formed integral with the portion of the at least one tubular shaped member.

4. The vessel occluder of claim 3, wherein the flexible closure member is formed as a coating of the bio-compatible material upon the portion of the at least one tubular shaped member.

5. The vessel occluder of claim 4, wherein the coating covers approximately two-thirds of the outer surface of the at least one tubular shaped member.

6. The vessel occluder of claim 1, wherein the flexible closure member has inner and outer surfaces and a generally tubular shaped cross-sectional configuration with first and second ends, the first closure member end being closed and the second closure member end being open and in fluid communication with the first open end of the at least one tubular shaped member, and the outer surfaces of the at least one tubular shaped member and the closure member being sealed with respect to each other.

7. The vessel occluder of claim 6, wherein the first closure member end has a generally bullet-shaped configuration.

8. The vessel occluder of claim 6, wherein the first closure member end has a small opening formed therein, adapted to permit a guide wire to pass therethrough and adapted to close in upon itself in a sealing relationship upon the guide wire being removed.

9. The vessel occluder of claim 6, wherein the flexible closure member defines a variable volume of space dependent upon a pressure force exerted by the body fluid upon the inner surface of the closure member.

10. The vessel occluder of claim 1, including first and second tubular shaped members connected by at least one flexible connector member, the flexible closure member being attached to at least the first end of the first tubular shaped member.

11. A method for permanently occluding a vessel in a person, the vessel having an inner wall surface and a body fluid flowing therethrough, comprising the steps of:

attaching a flexible closure member to a first open end of at least one metallic, generally tubular shaped, radially expandable stent, the flexible closure member being provided with a generally tubular shaped cross-sectional configuration, with inner and outer wall surfaces and first and second ends, the first closure member end being closed and the second closure end being open and in fluid communication with the first open end of the stent;

disposing the at least one stent and flexible closure member upon a catheter;

inserting the flexible closure member, at least one stent and catheter within the vessel to be occluded; and

expanding the at least one stent to permanently dispose at least a portion of the outer surface of the flexible closure member in a sealing relationship with the inner wall surface of the vessel, whereby the vessel is occluded and body fluid is prevented from flowing past the flexible closure member.

12. The method of claim 11, including a step of passing a guide wire through the first closed end of the flexible closure member, prior to inserting the flexible closure member, at least one stent, and catheter within the vessel to be occluded.

13. The method of claim 12, including a step of removing the guide wire and catheter after the at least one stent has been expanded.

14. The method of claim 11, wherein the body fluid exerts a pressure force upon the inner wall surface of the flexible closure member after the flexible closure member is permanently disposed in the vessel, and further including a step of dampening the pressure force exerted upon the inner wall surface of the flexible closure member.

15. The method of claim 14, wherein the pressure force is dampened by permitting the flexible closure to expand in response to the pressure force.

16. The method of claim 14, including a step of attaching the closure member to the at least one stent by forming the flexible closure member integral with the at least one stent.

17. The method of claim 16, wherein the second end of the flexible closure member is formed integral with the at least one stent by coating at least a portion of the at least one stent with a bio-compatible material, which forms the flexible closure member, to embed the portion of the at least one stent in the bio-compatible material.

18. The method of claim 11, including a step of forming the outer wall surface of the first closure member end with a generally bullet-shaped configuration.

19. An apparatus for providing permanent occlusion of a vessel in a person, the vessel having an inner wall surface and having a body fluid flowing therethrough comprising:

a catheter, having an expandable, inflatable portion associated therewith,

at least one metallic tubular shaped member, having an outer surface an interior and first and second open ends, the tubular shaped member having a first diameter which permits intraluminal delivery of the at least one tubular shaped member into the vessel to be occluded, the at least one tubular shaped member being disposed upon the expandable, inflatable portion of the catheter;

a flexible closure member, attached to the first open end of the at least one tubular member, which seals the first open end, the closure member having a first diameter, which is substantially the same as the at least one tubular shaped member first diameter; and

the at least one tubular shaped member and at least a portion of the flexible closure member having a second expanded diameter, upon an application from the interior of the tubular shaped member of a radially outwardly extending force, which second diameter is variable and controlled by an amount of force applied to the tubular shaped member, which force deforms at least a portion of the at least one tubular shaped member to retain the at least one tubular shaped member and the portion of the closure member with the second expanded diameter, whereby the closure member is disposed in sealing engagement with the inner wall surface of the vessel and occludes the vessel to prevent the body fluid from flowing past the closure member.

20. The apparatus of claim 19, wherein the flexible closure member is formed of a bio-compatible material which is disposed over at least a portion of the at least one tubular shaped member.

21. The apparatus of claim 20, wherein the flexible closure member is formed integral with the portion of the at least one tubular shaped member.

22. The apparatus of claim 21, wherein the flexible closure member is formed as a coating of the bio-compatible mterial upon the portion of the at least one tubular shaped member.

23. The apparatus of claim 22, wherein the coating covers approximately two-thirds of the outer surface of the at least one tubular shaped member.

24. The apparatus of claim 19, wherein the flexible closure member has inner and outer surfaces and a generally tubular shaped cross-sectional configuration with first and second ends, the first closure member end being closed and the second closure member end being open and in fluid communication with the first open end of the at least one tubular shaped member, and the outer surfaces of the at least one tubular shaped member and the closure member being sealed with respect to each other.

25. The apparatus of claim 24, wherein the first closure member end has a generally bullet-shaped configuration.

26. The apparatus of claim 24, wherein the first closure member end has a small opening formed therein, adapted to permit a guide wire to pass therethrough and adapted to close in upon itself in a sealing relationship upon the guide wire being removed.

27. The apparatus of claim 24, wherein the flexible closure member defines a variable volume of space dependent upon a pressure force exerted by the body fluid upon the inner surface of the closure member.

28. The apparatus of claim 19, including first and second tubular shaped members connected by at least one flexible connector member, the flexible closure member being attached to at least the first end of the first tubular shaped member.