Tubular medical prosthesis for use in a body lumen

• US 5,800,519 A
• Filed: 11/04/1996
• Issued: 09/01/1998
• Est. Priority Date: 04/29/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Kopin Corporation
• Inventors: Sandock, David L.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/743,395
• Time in Patent Office: 666 Days
• Field of Search: 623/1, 623/12, 606/192, 606/194, 606/195, 606/198, 606/108
• US Class Current: 623/1.22
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

An implantable self-expanding medical prosthesis. The prosthesis has a tube-form body with a body wall structure having a geometric pattern of cells defined by a series of elongate strands extending to regions of intersection and interlocking joints at said regions of intersection formed by a portion of at least one of said strands being helically wrapped about a portion of another.

Claims

1. An implantable medical prosthesis, comprising:

a tube-form body with a body wall structure having a geometric pattern of cells defined by a plurality of elongate strands extending to regions of intersection, and

interlocking joints at said regions of intersection formed by a portion of at least one of said strands being helically wrapped through an angle of at least 360°

about a portion of another said strand to form helically wrapped portions each having an axis, each strand in a cell having a strand angle relative to an axis of a joint in the cell that decreases upon circumferential expansion of the body, said interlocking joints constructed such that the axes of the helically wrapped portions are oriented substantially circumferentially with respect to said tube-form body.

2. The prosthesis of claim 1 wherein portions of each of said plurality of strands are helically wrapped about each other.

3. The prosthesis of claim 1 wherein said interlocking joints are constructed such that the helically wrapped portions of said strands can move relative to each other when the prosthesis is subject to varying radial compressive forces while still maintaining said cell structure.

4. The prosthesis of claim 1 wherein said interlocking joints are constructed with said strands helically wrapped through a single 360 degree rotation.

5. The prosthesis of claim 1 wherein the said prosthesis is self-expanding.

6. The prosthesis of claim 1 wherein said strands are metal wires composed of a Nickel-Titanium alloy.

7. The prosthesis of claim 1 further including a sleeve-type covering.

8. The prosthesis of claim 1 fully constructed for use in the biliary system having a fully expanded diameter of about 10 mm, and compressible to a diameter of about 9 French.

9. The prosthesis of claim 1 constructed to plastically deform during expansion.

10. The prosthesis of claim 1 constructed of a shape memory material to enable expansion in response to a temperature change.

11. The prosthesis of claim 1 including a drug-delivery layer carried by said wall structure.

12. The prosthesis of claim 1 constructed as a temporary stent, with an end of said stent connected to a drawing member that permits withdrawing of said stent after deployment.

13. The prosthesis of claim 1 wherein the tube form body has a compressed state and an expanded state such that the strand angle is in the range of 35°

-55°

in the expanded state.

14. The prosthesis of claim 1 wherein a strand at a helically wrapped portion has a single 360°

rotation relative to a second strand at the helically wrapped portion.

15. The prosthesis of claim 13 wherein each cell has a diamond shaped geometry in the expanded state.

16. The prosthesis of claim 13 constructed as a temporary stent, with an end of said stent connected to a drawing member that permits withdrawing of said stent after deployment.

17. The prosthesis of claim 1 wherein tube-form body expands from a compressed state to an expanded such that the strand angle in the expanded state is less than the strand angle in the compressed state.

18. A system for treating an occluded body lumen, comprising;

a prosthesis having a tube-form body with a body wall structure having a geometric pattern of cells defined by a series of elongate strands extending to regions of intersection, and interlocking joints at said regions of intersection formed by portions of said strands that are helically wrapped about each other through an angle of at least 360°

to form helically wrapped portions each having an axis, said interlocking joints constructed such that the axes of the helically wrapped portions are oriented substantially circumferentially with respect to said tube-form body, and

a delivery catheter constructed to receive said prosthesis in a compact state for delivery through the body to a desired site in said body lumen, the prosthesis having a length and a diameter in the compact state, and to allow expansion of said prosthesis to a larger diameter and a smaller length for engaging said body lumen at said desired site.

19. The system of claim 18 wherein said delivery catheter includes a sheath constructed to maintain said prosthesis in compact form during said delivery.

20. The system of claim 18 wherein said interlocking joints are constructed such that the helically wrapped portions of said strands can move relative to each other when the prosthesis is subject to varying radial compressive force while still maintaining said cell structure.

21. The system of claim 20 wherein said strands are helically wrapped through a single 360 degree rotation.

22. The system of claim 21 wherein said strands are metal wires composed of an Nickel-Titanium alloy.

23. The system of claim 22 fully constructed for use in the biliary system having a fully expanded diameter of about 10 mm, and compressible to a diameter of about 9 French.

24. A method for treating a body lumen, comprising:

providing a prosthesis having a tube-form body with a body wall structure having a body length and a geometric pattern of cells defined by a series of elongate strands extending to regions of intersection, and interlocking joints at said regions of intersection formed by portions of said strands that are helically wrapped about each other through an angle of at least 360°

to form helically wrapped portions each having an axis, said interlocking joints constructed such that the axes of the helically wrapped portions are oriented substantially circumferentially with respect to said tube-form body,

providing a delivery catheter constructed to receive said prosthesis in a compact state for delivery to a desired site in said body lumen and to allow expansion of said prosthesis to a larger diameter for engaging said body lumen at said desired site,

delivering said prosthesis to said site on said catheter, and

releasing said prosthesis at said site such that the body length is reduced upon expansion of the diameter of the prosthesis.

25. The method of claim 24 comprising:

a method of treating a body lumen having a highly tortuous bend, by providing and delivering said prosthesis to said bend.

26. The method of claim 25 wherein said bend approaches 80°

-90°

.

27. The method of claim 24 wherein the delivering step further comprises introducing the prosthesis into a biliary tract of a patient.

28. The method of claim 27 wherein the prosthesis is extending along a curve in the biliary tract.

29. An implantable medical prosthesis comprising:

a tube-form body with a body wall structure having a geometric pattern of cells defined by a plurality of elongate strands extending to regions of intersection, the tube-form body having a compact state and an expanded state; and

interlocking joints formed by a portion of at least one of said strands being helically wrapped through an angle of at least 360°

about a portion of another said strand, each interlocking joint having an axis extending through the helically wrapped portion, each strand in a cell having a strand angle relative to an axis of a joint in the cell in the range of 35°

-55°

when the tube-form body is in the expanded state, said interlocking joints constructed such that the axes of the helically wrapped portions of the interlocking joints are oriented substantially circumferentially with respect to said tube-form body.

30. The prosthesis of claim 29 wherein the interlocking joints are constructed that the axis of said helically wrapped portions of said strands can move relative to each other when the prosthesis is subject to varying radial compressive forces while still maintaining said cell structure.

31. The prosthesis of claim 29 wherein said strands are helically wrapped through a single 360 degree rotation.

32. The prosthesis of claim 29 wherein said prosthesis is self-expanding.

33. The prosthesis of claim 29 wherein said strands are metal wires composed of a Nickel-Titanium alloy.

34. The prosthesis of claim 29 further including a sleeve-type covering.

35. The prosthesis of claim 29 fully constructed for use in the biliary system having a fully expanded diameter of about 10 mm, and compressible to a diameter of about 9 French.

36. The prosthesis of claim 29 constructed to plastically deform during expansion.

37. The prosthesis of claim 29 constructed of a shape memory material to enable expansion in response to a temperature change.

38. The prosthesis of claim 29 including a drug-delivery layer carried by said wall structure.

39. The prosthesis of claim 29 constructed as a temporary stent, with an end of said stent connected to a drawing member that permits withdrawing of said stent after deployment.

40. A method for inserting a prosthesis in the biliary tract comprising:

providing a prosthesis having a tube-form body with a body wall structure having a body length and a geometric pattern of cells defined by a series of elongate strands extending to regions of intersection, and interlocking joints at said regions of intersection formed by portions of said strands that are helically wrapped about each other through an angle of at least 360°

to form helically wrapped portions are oriented substantially circumferentially with respect to said tube-form body;

providing a delivery catheter constructed to receive said prosthesis in a compact state for deliver to a desired site in said biliary tract and to allow expansion of said prosthesis to a larger diameter for engaging said biliary tract at said desired site, delivering said prosthesis at said sire such that the body length is reduced upon expansion of the diameter of the prosthesis such that the prosthesis extends along a portion of the biliary tract.

41. The method of claim 40 wherein each strand in a cell has a strand angle relative to the axis of a helically wrapped portion of a joint in the cell, the strand angle decreasing upon release in the biliary tract.