VASCULAR AND BODILY DUCT TREATMENT DEVICES AND METHODS

• US 20110009940A1
• Filed: 10/05/2009
• Published: 01/13/2011
• Est. Priority Date: 07/08/2009
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Miller, John H., Bonsignore, Craig L., Vu, Emily, Sanders, Elliot H., Pedersen, Kirk L., Grandfield, Ryan M., Wilson, Scott D.
• Granted Patent: US 8,795,345 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2230/0008 elliptical or oval

Abstract

A device including a self-expandable member having a proximal end portion, a main body portion and a distal end portion. Each of the self-expandable portions consists of a plurality of cell structures formed by intersecting strut members. In one implementation, at least one proximal cell structure in the proximal end portion has one or more struts that have a width and/or thickness greater than the width and/or thickness of the majority of strut members in the main body and distal end portions of the expandable member. Attached to at least one of the proximal-most cell structures in the proximal end portion is a proximally extending flexible wire having sufficient length and flexibility to navigate the tortuous vasculature of a patient. In another implementation, the device is delivered to the treatment site through the lumen of a delivery catheter.

Claims

1. A device comprising:

an elongate self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment within a vessel or duct of a patient, the expandable member comprising a plurality of cell structures, the expandable member having a proximal end portion with a proximal end, a cylindrical main body portion and a distal end portion with a distal end, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most linear wall segments that, in a two-dimensional view, form first and second substantially linear rail segments that each extend from a position at or near the proximal-most end of the expandable member to a distal position at or near the cylindrical main body portion.

2. The device of claim 1 wherein the self-expandable member has a longitudinal slit extending along at least a portion of the length of the self-expandable member between the proximal end and the distal end.

3. The device of claim 2 wherein the slit extends the entire length of the self-expandable member between the proximal end and the distal end.

4. The device of claim 2 wherein the slit extends diagonally along at least a portion of the length of the self-expandable member to form a spiral that extends along at least a portion of the circumference of the self-expandable member.

5. The device of claim 2 wherein the slit extends diagonally along at least a portion of the length of the self-expandable member to form a spiral that extends along at least the entire circumference of the self-expandable member.

6. The device of claim 2 wherein the slit originates at the distal position of one of the linear rail segments, or at a point distally adjacent to the distal position of one of the linear rail segments.

7. The device of claim 6 wherein the slit extends diagonally along at least a portion of the length of the self-expandable member to form a spiral that extends along at least a portion of the circumference of the self-expandable member.

8. The device of claim 6 wherein the slit extends diagonally along at least a portion of the length of the self-expandable member to form a spiral that extends along at least the entire circumference of the self-expandable member.

9. The device of claim 1 wherein the self-expandable member comprises a plurality of generally longitudinal undulating elements with adjacent undulating elements being interconnected in a manner to form the plurality of cell structures.

10. The device of claim 9 wherein the plurality of adjacent undulating elements are interconnected in a manner to cause the plurality of cell structures to be diagonally disposed in relation to one another.

11. The device of claim 1 further comprising a proximally extending elongate flexible wire connected to the proximal-most end of the self-expandable member.

12. The device of claim 11 further comprising a distally extending wire segment connected to the distal-most end of the self-expandable member.

13. The device of claim 1 wherein the cell structures in the main body portion of the self-expandable member are generally symmetrically aligned with one another along the circumference of the main body portion, the manufactured length to width ratio of the cell structures being greater than about 2.0.

14. The device of claim 1 wherein the cell structures in the cylindrical main body portion of the self-expandable member are generally symmetrically aligned with one another along the circumference of the main body portion, the length to width ratio of the cell structures being greater than about 1.25 when the self-expandable member is in the radially expanded position.

15. The device of claim 1, wherein the first and second substantially linear rail segments are of the same length.

16. The device of claim 1, wherein the proximal-most linear wall segments have a width and/or thickness greater than the width and/or thickness, respectively, of the wall segments in the other parts of the self-expandable member.

17. The device of claim 1, wherein in the radially expanded position the cylindrical main body portion comprises a first region and a second region, the second region having a diameter greater than the first region.

18. The device of claim 17, wherein the diameter of the second region is between about 25.0 to about 35.0 percent greater than the diameter of the first region.

19. The device of claim 17, wherein the second region is located distal to the first region.

20. The device of claim 17, wherein the second region is located at a distal end of the cylindrical body portion.

21. The device of claim 1, wherein at least a portion of the expandable member is coated with a radiopaque material.

22. The device of claim 1, further comprising radiopaque markers positioned at or near the proximal-most and distal-most ends of the expandable member.

23. The device of claim 1, wherein in the radially expanded position, the taper angle between the elongate wire and the two substantially continuous linear rail segments is between about 30.0 and about 40.0 degrees as measured in the two-dimensional view.

24. The device of claim 11, wherein the distal wire segment includes a taper portion and is bound by a coil structure.

25. The device of claim 24, wherein the coil structure comprises a radiopaque material.

26. The device of claim 1, wherein the length of the cylindrical main body portion is between about 2.5 and about 3.5 times greater than the length of either the first or second end portions.

27. The device of claim 1, wherein the cell structures in the proximal end portion and distal end portion are generally larger than the cell structures in the cylindrical main body portion.

28. The device of claim 1, further comprising a second proximally extending elongate wire connected to one of the first or second linear rail segments.

29. The device of claim 1, further comprising a second proximally extending elongate wire connected to the first linear rail segment and a third proximally extending elongate wire connected to the second linear rail segment.

30. The device of claim 29, wherein the second proximally extending elongate wire is connected at or near the distal end of the first substantially linear rail segment and the third proximally extending elongate wire is connected at or near the distal end of the second substantially linear rail segment.

31. The device of claim 1, wherein the plurality of cell structures are arranged to induce twisting of the self-expandable as the self-expandable member transitions between the unexpanded position and the expanded position.

32. A kit comprising:

an elongate flexible wire having a proximal end and a distal end with an elongate self-expandable member coupled to the distal end, the self-expandable member movable from a first delivery position to a second placement position, in the first delivery position the expandable member being in an unexpanded position and having a nominal first diameter and in the second position the expandable member being in a radially expanded position and having a second nominal diameter greater than the first nominal diameter for deployment in a bodily duct or vasculature of a patient, the self-expandable member comprising a plurality of cell structures, the self-expandable member having a proximal end portion with a proximal end, a cylindrical main body portion and a distal end portion with a distal end, the cell structures in the main body portion extending circumferentially around a longitudinal axis of the expandable member, the cell structures in the proximal and distal end portions extending less than circumferentially around the longitudinal axis of the expandable member, the outer-most cell structures in the proximal end portion having proximal-most linear wall segments that, in a two-dimensional view, form first and second substantially linear rail segments that each extend from a position at or near the proximal-most end of the expandable member to a distal position at or near the cylindrical main body portion, the elongate wire with the expandable member having a first length; and

a delivery catheter having a second length and sufficient flexibility to navigate the bodily duct or vasculature of the patient, the delivery catheter having a proximal end, a distal end and an inner lumen, the inner lumen having a diameter sufficient to receive the self-expandable member in its unexpanded position and for advancing the unexpanded member from the proximal end to the distal end of the catheter, the second length being less than the first length to allow distal advancement of the self-expandable member beyond the distal end of the catheter to permit the expandable member to deploy toward its expanded position,

the distal end of the catheter and the self-expandable member configured to permit proximal retraction of the self-expandable member into the lumen of the catheter when the self-expandable member is partially or fully deployed outside the distal end of the catheter.

33. The kit of claim 32 wherein, the self-expandable member has a longitudinal slit extending along at least a portion of the length of the self-expandable member between the proximal end and the distal end.