Micro-porous mesh stent with hybrid structure

• US 6,312,463 B1
• Filed: 02/01/2000
• Issued: 11/06/2001
• Est. Priority Date: 02/01/2000
• Status: Expired due to Term

• Current Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Yang, Yi, Rourke, Jonathan M.
• Primary Examiner(s): O'Connor, Cary E.
• Application Number:
  US09/495,827
• Time in Patent Office: 644 Days
• Field of Search: 606/194, 606/198, 606/200, 623/1.15, 623/1.18, 623/1.39, 623/1.23, 623/1.4
• US Class Current: 623/1.39
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100-150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage. The tubular element is deployed, and the support element is expanded to an enlarged condition at the treatment location to engage an interior surface of the tubular element, thereby securing the tubular element and holding the lumen of the treatment location open.

Claims

1. A micro-porous mesh structure for supporting a wall of a body passage, comprising:

a generally tubular body having a contracted condition for facilitating delivery into the body passage, and an enlarged condition for engaging the wall of the body passage, the tubular body being biased to its enlarged condition;

a plurality of struts formed integrally onto the tubular body and spaced along a length of the tubular body for supporting the tubular body against the wall of the body passage, the struts separating relatively thin-walled regions therebetween; and

a plurality of openings in the relatively thin-walled regions of the tubular body defining a micro-porous mesh pattern therein;

wherein the tubular body comprises a coiled-sheet having overlapping inner and outer sections.

2. The micro-porous mesh structure of claim 1, wherein each opening has a maximum dimension of not more than about 400 micrometers (0.016 inch).

3. The micro-porous mesh structure of claim 1, wherein the tubular body has a wall thickness of not more than about 25 micrometers (0.001 inch).

4. The micro-porous mesh structure of claim 1, wherein the inner and outer sections define a helical seam therebetween that extends down a length of the tubular body.

5. The micro-porous mesh structure of claim 1, wherein the inner and outer sections define a longitudinal seam therebetween that extends substantially parallel to a longitudinal axis of the tubular body.

6. The micro-porous mesh structure of claim 1, wherein the plurality of struts have a thickness of between about 100 micrometers (0.004 inch) and about 150 micrometers (0.006 inch).

7. The micro-porous mesh structure of claim 1, wherein the plurality of openings are spaced apart from one another on a surface of the tubular body such that remaining tubular body material provides not more than about 20 percent coverage of the wall of the body passage.

8. A micro-porous mesh structure for supporting a wall of a body passage, comprising:

a generally tubular body having a contracted condition for facilitating delivery into the body passage, and an enlarged condition for engaging the wall of the body passage, the tubular body being biased to its enlarged condition;

a plurality of struts formed integrally onto the tubular body and spaced along a length of the tubular body for supporting the tubular body against the wall of the body passage, the struts separating relatively thin-walled regions therebetween; and

a plurality of openings in the relatively thin-walled regions of the tubular body defining a micro-porous mesh pattern therein;

wherein the tubular body comprises a shape memory alloy.

9. The micro-porous mesh structure of claim 8, wherein the shape memory alloy is plastically deformable at or below substantially ambient temperatures to facilitate compressing the tubular body into its contracted condition.

10. The micro-porous mesh structure of claim 9, wherein the plurality of openings are at least partially compressed when the body is placed in its contracted condition.

11. The micro-porous mesh structure of claim 9, wherein the shape memory alloy has a transition temperature between substantially ambient temperatures and body temperature, whereby the tubular body is biased to the enlarged condition when exposed to body temperature.

12. The micro-porous mesh structure of claim 11, wherein the plurality of openings are biased to return to a fully open condition when exposed to body temperature.

13. A prosthesis for supporting a wall of a body passage, comprising:

a substantially flexible, conformable tubular element defining a length and a circumference and having a plurality of openings defining a micro-porous mesh pattern therein, the tubular element having a contracted condition for facilitating delivery into the body passage, and an enlarged condition for engaging the wall of the body passage; and

a support element comprising a plurality of struts for engaging an interior surface of the tubular element, the support structure being expandable between a contracted condition and an enlarged condition for supporting the tubular element;

wherein the support element is biased to the enlarged condition at body temperature for substantially securing the tubular element against the wall of the body passage.

14. The prosthesis of claim 13, wherein the plurality of openings each have a maximum dimension of not more than about 400 micrometers (0.016 inch).

17. The prosthesis of claim 13, wherein the support element is attachable to the tubular element during deployment.

18. The prosthesis of claim 13, wherein the support element is substantially permanently attached to the interior surface of the tubular element.

19. The prosthesis of claim 13, wherein the support element has a wall thickness of not more than about 150 micrometers (0.006 inch).

20. The prosthesis of claim 13, wherein the tubular element has a wall thickness of not more than about 25 micrometers (0.001 inch).

21. The prosthesis of claim 13, wherein the tubular element has a substantially smooth wall and side edges.

15. The prosthesis of claim wherein the support element comprises a shape memory alloy.

16. The prosthesis of claim 15, wherein the shape memory alloy comprises Nitinol having a transition temperature between a substantially ambient temperature and body temperature.

22. A prosthesis for supporting a wall of a body passage, comprising:

a substantially flexible, conformable tubular element defining a length and a circumference and having a plurality of openings defining a micro-porous mesh pattern therein, the tubular element having a contracted condition for facilitating delivery into the body passage, and an enlarged condition for engaging the wall of the body passage; and

a support element comprising a plurality of struts for engaging an interior surface of the tubular element, the support structure being expandable between a contracted condition and an enlarged condition for supporting the tubular element;

wherein the support element comprises a coiled-sheet stent.

23. A prosthesis for supporting a wall of a body passage, comprising:

a substantially flexible, conformable tubular element defining a length and a circumference and having a plurality of openings defining a micro-porous mesh pattern therein, the tubular element having a contracted condition for facilitating delivery into the body passage, and an enlarged condition for engaging the wall of the body passage; and

a support element comprising a plurality of struts for engaging an interior surface of the tubular element, the support structure being expandable between a contracted condition and an enlarged condition for supporting the tubular element;

wherein the support element slidably engages the tubular element in the enlarged condition.

24. A prosthesis for supporting a wall of a body passage, comprising:

a substantially flexible, conformable tubular element defining a length and a circumference and having a plurality of openings defining a micro-porous mesh pattern therein, the tubular element having a contracted condition for facilitating delivery into the body passage, and an enlarged condition for engaging the wall of the body passage; and

a support element comprising a plurality of struts for engaging an interior surface of the tubular element, the support structure being expandable between a contracted condition and an enlarged condition for supporting the tubular element;

wherein the tubular element comprises a coiled-sheet having overlapping inner and outer sections.

25. A prosthesis for supporting a wall of a body passage, comprising:

a substantially flexible, conformable tubular element defining a length and a circumference and having a plurality of openings defining a micro-porous mesh pattern therein, the tubular element having a contracted condition for facilitating delivery into the body passage, and an enlarged condition for engaging the wall of the body passage; and

a support element comprising a plurality of struts for engaging an interior surface of the tubular element, the support structure being expandable between a contracted condition and an enlarged condition for supporting the tubular element;

wherein the tubular element comprises a shape memory alloy.

26. The prosthesis of claim 25, wherein the shape memory alloy has a transition temperature between substantially ambient temperatures and body temperature, whereby the tubular element is biased to its enlarged condition when exposed to body temperature.

27. A method for making a prosthesis for supporting a wall of a body passage, the method comprising the steps of:

providing a sheet formed from a shape memory alloy having an initial wall thickness;

removing portions of the sheet to provide a plurality of struts having a thickness similar to the initial wall thickness;

forming a mesh pattern comprising a plurality of micro-porous openings in relatively thin-walled regions between the struts; and

forming the sheet into a generally tubular body.

28. The method of claim 27, wherein each opening has a maximum dimension of not more than about 200 micrometers (0.008 inch).

29. The method of claim 27, wherein the sheet has a wall thickness of not more than about 25 micrometers (0.001 inch).

30. The method of claim 27, wherein the mesh pattern is formed by chemically etching, laser cutting, punching, or drilling the micro-porous openings through the sheet.

31. The method of claims 27, wherein the step of forming the sheet into a generally tubular body comprises rolling the sheet into a coiled-sheet having overlapping inner and outer sections.

32. The method of claim 27, wherein the shape memory alloy has a transition temperature between a substantially ambient temperature and body temperature, and wherein the method comprises the additional steps of:

heat treating the tubular body at a first temperature substantially higher than the transition temperature to program an expanded condition for engaging the wall of the body passage into the shape memory material;

cooling the tubular body to a second temperature below the transition temperature; and

compressing the tubular body at the second temperature into a contracted condition for facilitating delivery into the body passage.

33. A method for supporting a wall of a predetermined location within a body passage using a prosthesis comprising a substantially flexible, conformable tubular element including a micro-porous mesh pattern therein, and a support element, the method comprising the steps of:

providing the tubular and support elements in contracted conditions on a distal region of a delivery device, the tubular element and the support element being placed adjacent one another on the distal region of the delivery device;

advancing the distal region of the delivery device endoluminally within the body passage to the predetermined location;

deploying the tubular element at the predetermined location such that the tubular element substantially conforms to the wall of the predetermined location;

directing the support element across the predetermined location after the tubular element is deployed; and

expanding the support element to an enlarged condition at the predetermined location to engage an interior surface of the tubular element, thereby substantially securing the tubular element against the wall of the predetermined location.

34. A method for supporting a wall of a predetermined location within a body passage using a prosthesis comprising a substantially flexible, conformable tubular element including a micro-porous mesh pattern therein, and a support element, the method comprising the steps of:

providing the tubular and support elements in contracted conditions on a distal region of a delivery device, the delivery device comprising one or more constraints for preventing the tubular and support elements from expanding from their contracted conditions after the tubular and support elements are placed on the distal region of the delivery device;

advancing the distal region of the delivery device endoluminally within the body passage to the predetermined location;

deploying the tubular element at the predetermined location such that the tubular element substantially conforms to the wall of the predetermined location; and

expanding the support element to an enlarged condition at the predetermined location to engage an interior surface of the tubular element, thereby substantially securing the tubular element against the wall of the predetermined location;

wherein the support element is biased to expand to its enlarged condition at body temperature, and

wherein the step of expanding the support element comprises releasing the support element from at least one of the constraints, the support element automatically expanding to engage the interior surface of the tubular element.

35. The method of claim 34, wherein at least one of the constraints comprises a sheath overlying at least one of the tubular and support elements.

36. The method of claim 34, wherein the tubular element is deployed at the treatment location by releasing it from at least one of the constraints.

37. The method of claim 34, wherein the tubular element is expanded to an enlarged condition as the support element expands to its enlarged condition, the tubular element thereby conforming substantially to the shape of the body passage.

38. The method of claim 34, wherein the tubular element is biased to expand to an enlarged condition at body temperature, and wherein the step of deploying the tubular element comprises releasing the tubular element from at least one of the constraints, the tubular element automatically expanding to its enlarged condition to conform to the wall of the predetermined location.

39. The method of claim 38, wherein the tubular element is mounted concentrically over the support element on the distal region of the delivery device, and wherein the tubular and support elements are released simultaneously from the constraints, the tubular element expanding more rapidly than the support element to conform to the cross-section of the predetermined location before being substantially secured by the support element against the wall thereof.

40. The method of claim 34, wherein the predetermined location comprises a stenotic region.

41. The method of claim 34, wherein the body passage comprises a carotid artery, a coronary artery, or a cerebral artery.

42. A method for treating a bifurcation between a main blood vessel and a branch blood vessel using a prosthesis comprising first and second substantially flexible, conformable micro-porous tubular elements, and an open-celled support element, the method comprising the steps of:

advancing the first and second tubular elements and the support element in a contracted condition endoluminally into the main blood vessel;

deploying the first tubular element in one of the main and branch blood vessel distally of the bifuircation such that the first tubular element substantially conforms to the wall of the respective blood vessel; and

deploying the second tubular element in the main blood vessel proximally of the bifurcation such that the second tubular element substantially conforms to the wall of the main blood vessel; and

expanding the support element to an enlarged condition across the bifurcation to engage an interior surface of each of the first and second tubular elements, thereby substantially securing the first and second tubular elements against the wall of their respective blood vessels.

43. The method of claim 42, wherein the first and second tubular elements are mounted to a distal portion of a delivery device in contracted conditions, and wherein the advancing step comprises advancing the distal portion with the first and second tubular elements in their contracted conditions into the main blood vessel.

44. The method of claim 43, wherein the first and second tubular elements are spaced apart from one another on the distal portion by a distance corresponding substantially to a width of the bifurcation.

45. The method of claim 42, wherein the support element is mounted to the distal portion of the delivery device in its contracted condition before being advanced into the main blood vessel.

46. The method of claim 45, wherein the delivery device comprises a sheath overlying the first and second tubular elements, and wherein the steps of deploying the first and second tubular elements comprises successively withdrawing the sheath from over the first and second tubular elements.

47. The method of claim 46, wherein the support element is mounted on the distal portion underneath the first and second tubular elements, and wherein the support element is deployed from the delivery device as the sheath is withdrawn from over the first and second tubular elements.

49. The method of claim 42, wherein the first and second tubular elements are biased to an enlarged condition for conforming to the wall of a blood vessel such that the first and second tubular elements automatically expand to their enlarged conditions during the deploying steps to conform substantially to the wall of the respective blood vessels.

48. The method of claims wherein the support element is biased to its enlarged condition at body temperature such that the support element automatically expands to the enlarged condition as it is deployed from the delivery device.