Occlusion, anchoring, tensioning and flow direction apparatus and methods for use

• US 6,635,068 B1
• Filed: 02/09/1999
• Issued: 10/21/2003
• Est. Priority Date: 02/10/1998
• Status: Expired due to Term

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Artemis Medical, Inc. (Johnson & Johnson)
• Inventors: Dubrul, William Richard, Fulton, Richard E
• Primary Examiner(s): Truong, Kevin T.
• Assistant Examiner(s): Ho, (Jackie) Tan-Ugen T.
• Application Number:
  US09/248,083
• Time in Patent Office: 1,715 Days
• Field of Search: 606/191, 606/151, 606/198, 606/200, 623/1, 623/1.2, 604/194
• 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 17/12109 in a blood vessel
• 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 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

Wires, catheters, endoscopes, etc. and their methods that have flow directed distal ends, which allow and facilitate management of these devices during use are disclosed. Additionally instant invention allows for distal anchoring so that the device will remain in a location once it has arrived and its method for use. Further, the instant invention describes an apparatus and method for a tensioning characteristic to be applied along the device once it is place that will facilitate the passing of another member along the initially placed member. Last, a novel occluder is disclosed and its method of use.

Claims

1. An improved medical device for use in the body, comprising:

a support element insertable into the body, said support element comprising a shaft and an elongate member, said support element having a distal end;

an expandable element supported on said distal end of said support element, said expandable element movable from a radially compressed state, for insertion of said expandable element into the body, to a radially expanded state using the shaft and the elongate member to axially compress and thereby radially expand said expandable element;

said expandable element comprising structural members which define openings therebetween;

said expandable element having a radial dimension in the radially expanded state which is at least four times larger than when in the radially compressed state; and

said expandable element comprising an expandable polymer at least substantially filling said openings to create a substantially non-porous expandable element when in the radially expanded state.

2. The device of claim 1 wherein the polymer comprises a film layer.

3. The device of claim 2 wherein the expandable element is an annular braided expandable element and the film layer contacts the annular braided expandable element.

4. The device of claim 3 wherein the film layer covers the annular braided expandable element.

5. The device of claim 1 wherein said expandable element is a multi-wing malecot expandable element and said film comprises an annular elastomeric film around said wings.

6. The device of claim 1 wherein said shaft and expandable element define a longitudinally-extending through lumen to permit an elongate element to pass along the shaft and completely through the expandable element.

7. The device of claim 1 wherein said expandable element is an anchoring element for a supplemental medical device.

8. The device of claim 1 wherein said expandable element is a tubular channel occlusion element.

9. The device of claim 1 wherein said expandable element is a flow-directed, releasable expandable element.

10. The device of claim 1 wherein said expandable element is an annular braided expandable element having individual yarns sufficiently flexible to be moved between said states and sufficiently stiff to substantially hold said expanded state when in a targeted area within a body.

12. The device of claim 1 or 11 wherein the expandable element is releasable from both the elongate member and the shaft.

13. The device of claim 1 or 11 wherein the polymer comprises thin strands of expandable polymer.

14. The device of claim 13 wherein the expandable element is an annular braided expandable element and the expandable polymer contacts the annular braided expandable element.

15. The device of claim 14 wherein the expandable polymer covers the annular braided expandable element.

16. The device of claim 14 wherein the polymer interweaves the annular braided expandable element.

17. The device of claim 1 or 11 wherein said expandable element is sized so to contact a wall of a passageway in which it is inserted.

18. The device of claim 1 or 11 wherein the expandable element is bioabsorbable.

19. The device of claim 1 or 11 wherein said expandable element comprises an annular braided expandable element.

20. The device of claim 1 or 11 wherein said expandable element comprises a multi-wing malecot expandable element.

11. An improved medical device for use in the body, comprising:

a support element insertable into the body, said support element comprising a shaft and an elongate member, said support element having a distal end;

an expandable element supported on said distal end of said support element, said expandable element movable from a radially compressed state, for insertion of said expandable element into the body, to a radially expanded state using the shaft and the elongate member to axially compress and thereby radially expand said expandable element;

said expandable element comprising structural members which define openings therebetween;

said expandable element comprising a expandable polymer at least substantially filling said openings to create a substantially non-porous expandable element when in the radially expanded state; and

the expandable element supported on said distal end of said support element, said expandable element movable from a radially expanded state, to a radially compressed state for insertion of said expandable element into the body using the shaft and the elongate member to axially extend and thereby radially compress said expandable element.

21. An improved medical device for use in the body, comprising:

a support element insertable into the body, said support element comprising a shaft and an elongate member, said support element having a distal end;

an expandable element supported on said distal end of said support element, said expandable element movable from a radially compressed state, for insertion of said expandable element into the body, to a radially expanded state using the shaft and the elongate member to axially compress and thereby radially expand said expandable element;

said expandable element comprising an annular braided expandable element comprising structural members which define openings therebetween;

said expandable element comprising a film at least substantially filling said openings to create a substantially non-porous expandable element; and

the expandable element being releasable from both the elongate member and the shaft.

22. The device of claim 21 wherein the expandable element is releasable from the elongate member and the shaft when in the radially expanded state.

23. The device of claim 22 wherein the expandable element is bioabsorbable.

24. A method for placing an expandable element within a hollow body structure within a body through which fluid flows, comprising:

selecting a medical device comprising a support member and an expandable element at the distal end of the member, the expandable element comprising structural members which define openings therebetween and a film at least substantially filling said openings;

the selecting step to comprising choosing a flow-directed expandable element as the expandable element;

positioning the flow-directed expandable element at a chosen location within a hollow body structure of a body;

expanding the flow-directed expandable element from a radially compressed state to a radially expanded state; and

releasing the flow-directed expandable element from the support member thereby permitting the flow-directed expandable element to be directed by fluid flowing through said hollow body structure.

25. An improved medical device for use in the body, comprising:

a support element insertable into the body, said support element comprising a shaft and an elongate member, said support element having a distal end;

an axially-compressible, radially-expandable expandable element supported on said distal end of said support element, said expandable element movable from a radially compressed state, for insertion of said expandable element into the body, away from a relaxed, radially-contracted state to a radially expanded state using the shaft and the elongate member to axially compress and thereby radially expand said expandable element;

said expandable element comprising structural members which define openings therebetween;

said expandable element having a radial dimension in the radially expanded state which is at least four times larger than when in the radially compressed state; and

said expandable element comprising a stretchable film at least substantially filling said openings to create a substantially non-porous expandable element when in the radially expanded state.

26. The device of claim 25 wherein the expandable element is an annular braided expandable element and the film comprises a film layer which contacts the annular braided expandable element.

27. The device of claim 25 wherein the expandable element is an annular braided expandable element and the film comprises an expandable polymer which contacts the annular braided expandable element.

29. The device of claim 25 or 28 wherein the expandable element is releasable from both the elongate member and the shaft.

28. An improved medical device for use in the body, comprising:

a support element insertable into the body, said support element comprising a shaft and an elongate member, said support element having a distal end;

an axially-compressible, radially-expandable expandable element supported on said distal end of said support element, said expandable element movable from a radially compressed state, for insertion of said expandable element into the body, away from a relaxed, radially-contracted state to a radially expanded state using the shaft and the elongate member to axially compress and thereby radially expand said expandable element;

said expandable element comprising structural members which define openings therebetween;

said expandable element having a radial dimension in the radially expanded state which is at least four times larger than when in the radially compressed state; and

said expandable element comprising an expandable polymer at least substantially filling said openings to create a substantially non-porous expandable element when in the radially expanded state.

30. A method for placing an expandable element within a body comprising:

selecting a medical device comprising a support member and an axially-compressible, radially-expandable expandable element at the distal end of the support member, the expandable element comprising structural members which define openings therebetween and a film at least substantially filling said openings;

positioning the expandable element at a chosen location within a body;

axially compressing the expandable element away from a relaxed, radially-contracted state thereby expanding the expandable element from a radially compressed state to a radially expanded state;

releasing the expandable element from the support member; and

removing the support member from the body with the expandable element in the expanded state within the body.

31. A method for placing an expandable element within a body comprising:

selecting a medical device comprising a support member and an axially-compressible, radially-expandable expandable element at the distal end of the support member, the expandable element comprising structural members which define openings therebetween and an expandable polymer at least substantially filling said openings;

positioning the expandable element at a chosen location within a body;

axially compressing the expandable element away from a relaxed, radially-contracted state thereby expanding the expandable element from a radially compressed state to a radially expanded state;

releasing the expandable element from the support member; and

removing the support member from the body with the expandable element in the expanded state within the body.

32. An improved medical device for use in the body, comprising:

a support element insertable into the body, said support element comprising a shaft and an elongate member, said support element having a distal end;

an axially-compressible, radially-expandable expandable element supported on said distal end of said support element, said expandable element movable from a radially compressed state, for insertion of said expandable element into the body, away from a relaxed, radially-contracted state to a radially expanded state using the shaft and the elongate member to axially compress and thereby radially expand said expandable element;

said expandable element comprising an annular braided expandable element comprising structural members which define openings therebetween;

said expandable element comprising a film at least substantially filling said openings to create a substantially non-porous expandable element; and

the expandable element being releasable from both the elongate member and the shaft.

33. A method for placing an expandable element within a hollow body structure within a body through which fluid flows, comprising:

selecting a medical device comprising a support member and an axially-compressible, radially-expandable expandable element at the distal end of the support member, the expandable element comprising structural members which define openings therebetween and a film at least substantially filling said openings;

the selecting step comprising choosing a flow-directed expandable element as the expandable element;

positioning the flow-directed expandable element at a chosen location within a hollow body structure of a body;

expanding the flow-directed expandable element away from a relaxed, radially contracted state by expanding the expandable element from a radially compressed state to a radially expanded state; and

releasing the flow-directed expandable element from the support member thereby permitting the flow-directed expandable element to be directed by fluid flowing through said hollow body structure.