Angioplasty stent

• US 6,974,475 B1
• Filed: 12/08/1987
• Issued: 12/13/2005
• Est. Priority Date: 12/08/1987
• Status: Active Grant

• Current Assignee: W H Wall Family Holdings LLLP
• Original Assignee: W H Wall Family Holdings LLLP
• Inventors: Wall, W. Henry
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US07/129,834
• Time in Patent Office: 6,580 Days
• Field of Search: 128/1.R, 128/334.C, 128/334.R, 128/898, 623/1, 623/12, 623 11- 115, 623/1.18, 623 12- 123, 623 144- 146, 623/1.3, 623/1.36, 606/108, 606/151, 606190-194, 606/198, 604/264, 604/265, 604/280
• US Class Current: 623/1.46
• 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 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

A prosthesis for use in preventing restenosis after angioplasty is formed of plastic or sheet metal, and is expandable and contractable for placement. The prosthesis can be inserted while in a collapsed position, then expanded and locked at the larger diameter. Spring force can be provided by the material itself, or metal springs can be embedded within the walls of the prosthesis. Preferably, the walls have holes therethrough to promote tissue growth; and, in one embodiment, the holes are in the form of slots so that the prosthesis is segmented and can bend longitudinally.

Claims

1. A prosthesis for use in maintaining an opening within a vessel, said prosthesis comprising a sleeve having a wall, said wall defining a discontinuity longitudinally thereof providing a first edge and a second edge of said wall, said first edge being selectively receivable within said sleeve for allowing said sleeve selectively to assume a first position wherein said first edge of said wall moves inwardly for providing a collapsed diameter of said sleeve, and a second position wherein said wall moves outwardly for providing an expanded diameter of said sleeve, means for urging said wall in one direction towards either said collapsed diameter or said expanded diameter, and locking means for preventing motion of said wall by said means for urging said wall in one direction,

said means for urging said wall in one direction including memory of said wall,

said one direction being inwardly towards said collapsed diameter, said locking means comprising a first hook means carried by said first edge of said wall, and a second hook means carried by said second edge of said wall, said first and second hook means being engageable with each other for fixing the diameter of said sleeve.

2. A prosthesis as claimed in claim 1, said first edge and said second edge of said wall being normally overlapped at said discontinuity, said first and second hook means being carried by said wall adjacent to said discontinuity, said wall adjacent to said discontinuity being biased so that said first hook means and said second hook means interchange with each other when said wall is no longer overlapped, the arrangement being such that said first and second hook means normally engage for fixing the diameter of said sleeve, and said first and second hook means cannot engage when said hook means interchange with each other.

3. A prosthesis as claimed in claim 1, said one direction being outwardly towards said expanded diameter, said locking means including a plurality of lugs, at least one lug of said plurality of lugs being on each side of said discontinuity in said wall, and pin means receivable through said lugs for holding said sleeve inwardly at said collapsed diameter.

4. A prosthesis as claimed in claim 3, said lugs being so placed that said wall is overlapped when said lugs are aligned, said pin comprising a wire extending longitudinally of said sleeve and selectively movable for disengagement from said lugs.

5. A prosthesis as claimed in claim 4, and further including second locking means for fixing the diameter of said wall at said expanded diameter.

6. A prosthesis as claimed in claim 1, said wall comprising a plurality of segments, said sleeve having a top and a bottom extending longitudinally of said sleeve, a spine extending longitudinally of said sleeve along said bottom of said sleeve, each segment of said plurality of segments extending from said spine, around one side of said sleeve and to said top of said sleeve, said plurality of segments being spaced apart along each side of said spine so that said sleeve is longitudinally bendable.

7. A prosthesis for use in maintaining an opening within a vessel, said prosthesis comprising a sleeve having a wall, said wall defining a discontinuity longitudinally thereof for providing a first edge and a second edge of said wall, said first edge being selectively receivable within said sleeve for allowing said sleeve selectively to assume a first position wherein said first edge of said wall moves inwardly for providing a collapsed diameter of said sleeve, and a second position wherein said wall moves outwardly for providing an expanded diameter of said sleeve, means for urging said wall in one direction towards either said collapsed diameter or said expanded diameter, and locking means for preventing motion of said wall by said means for urging said wall in one direction, said wall comprising a plurality of segments, said sleeve having a top and a bottom extending longitudinally of said sleeve, a spine extending longitudinally of said sleeve along said bottom of said sleeve, each segment of said plurality of segments extending from said spine, around one side of said sleeve and to said top of said sleeve, said plurality of segments being spaced apart along each side of said spine so that said sleeve is longitudinally bendable and further including a plurality of lugs, each lug of said plurality of lugs being carried generally on one of said segments at said top of said sleeve, the arrangement being such that said sleeve is moved inwardly to said collapsed diameter when said lugs are aligned, and a pin receivable through said lugs constituting said locking means.

8. A prosthesis as claimed in claim 7, said means for urging said wall in one direction including memory of said wall.

9. A prosthesis as claimed in claim 7, said means for urging said wall in one direction including spring means embedded within said wall.

10. A stent for placement within a vessel, said stent being generally cylindrical in shape and having a wall, said wall defining a discontinuity longitudinally thereof for providing a first edge and a second edge of said wall, said first edge being selectively receivable within said sleeve for allowing said sleeve selectively to assume a first position wherein said wall moves inwardly for providing a collapsed diameter of said sleeve, and a second position wherein said wall moves outwardly for providing an expanded diameter of said sleeve, means for urging said wall in one direction towards either said collapsed diameter or said expanded diameter, said wall being formed of sheet material defining a plurality of openings therethrough.

11. A stent as claimed in claim 10, said sheet material comprising an implantable metal.

12. A stent as claimed in claim 10, said sheet material comprising an implantable plastic material formed into said sheet material.

13. A stent as claimed in claim 12, said sheet material further including a filamentary mesh coated with said plastic material.

14. A stent as claimed in claim 12, said sheet material further including a plurality of spring members embedded within said sleeve.

15. A method of placement of a sleeve into an affected lumen of a human body following angioplasty for preventing re-stenosis of the affected lumen and maintaining at least a minimum opening in the lumen comprising:

providing a radially collapsible sleeve formed in a mesh, a coating of material applied to said mesh and defining a plurality of openings throughout the mesh to allow tissue to grow there through, and said mesh biased toward its collapsed position,

providing a catheter,

mounting the sleeve in its radially collapsed position on the catheter,

inserting the catheter with the collapsed sleeve mounted thereon into a lumen of the body,

carrying the sleeve in its collapsed position with the catheter along the length of the lumen to a position in the lumen where the minimum opening in the lumen is to be established,

radially expanding the catheter inside the sleeve,

radially expanding the sleeve in response to the radial expansion of the catheter in the position of the lumen where the minimum opening in the lumen is to be established,

radially expanding the lumen in response to the radial expansion of the sleeve,

maintaining the sleeve in its radially expanded position,

collapsing the catheter inside the sleeve,

withdrawing the catheter from the sleeve and from the lumen,

promoting epithelialization of the lumen about the sleeve and its openings for incorporating the sleeve into the lumen, and

preventing re-stenosis of the lumen with the sleeve.

16. The method of claim 15, wherein the step of providing a catheter comprises providing a catheter with a balloon at its distal end, and the step of radially expanding the catheter comprises inflating the balloon.

17. The method of claim 15, wherein the sleeve when in its collapsed position defines a longitudinal gap and the sleeve is in the form of a coil, and wherein the step of radially expanding the sleeve comprises transforming the sleeve from its coiled position into an open cylindrical position.

18. The method of claim 17, wherein the step of radially expanding the sleeve comprises expanding the sleeve to a predetermined circumference.

19. The method of claim 17, wherein the sleeve has ends adjacent its gap, and the step of maintaining the sleeve in its radially expanded position comprises locking the ends of the sleeve together.

20. The method of claim 19, wherein the step of locking the ends of the sleeve together comprises placing the ends of the sleeve in overlying relationship, and locking the ends of the sleeve together in overlying relationship.

21. The method of claim 19, wherein the sleeve has connectors on at least one of its ends, and wherein the step of locking the ends of the sleeve together comprises locking the connectors to the ends to establish the sleeve in a position of a predetermined circumference.

22. A method of placement of a sleeve into an affected lumen of a human body for preventing re-stenosis following angioplasty of the affected lumen and maintaining at least a minimum opening in the lumen, comprising:

providing a radially collapsible sleeve biased toward its radially collapsed position and formed in a mesh, a coating applied to the mesh defining a plurality of openings throughout the mesh that allow tissue to grow through the openings and forming a smooth surface-on the mesh, with said sleeve positioned in its radially collapsed position,

carrying the sleeve in its collapsed position with a catheter along the length of a lumen to a position in the lumen where the minimum opening in the lumen is to be established,

radially expanding the sleeve,

radially expanding the lumen in response to the expansion of the sleeve, and locking the sleeve in its radially expanded position, to promote epithelialization through the openings of the sleeve to promote incorporation of the stent into the vessel wall.

23. The method of claim 22, wherein the step of locking the sleeve in its radially expanded position comprises locking the sleeve to itself in response to radially expanding the sleeve.

24. The method of claim 22, wherein the step of providing a sleeve formed in a mesh and a coating applied to the mesh, includes the coating defining rounded surfaces for avoiding trauma to the lumen.

27. The method of claim 22, and further including the step of retarding movement of the sleeve along the length of the lumen in response to expanding the sleeve.

25. A method of placement of a sleeve into an affected lumen of a human body for preventing re-stenosis following angioplasty of the affected lumen and maintaining at least a minimum opening in the lumen, comprising:

providing a radially collapsible sleeve formed in a mesh defining a plurality of openings through out the mesh that allow tissue to grow through the openings and a coating applied to the mesh for defining a plurality of openings that allow promotion of epithelialization, with said sleeve positioned in its radially collapsed position,

carrying the sleeve in its collapsed position along the length of a lumen to a position in the lumen where the minimum opening in the lumen is to be established,

radially expanding the sleeve,

radially expanding the lumen in response to the expansion of the sleeve, and locking the sleeve in its radially expanded position, to promote epithelialization through the openings of the sleeve to promote incorporation of the stent into the vessel wall,

wherein the step of providing a sleeve comprises providing a sleeve that defines a longitudinal gap with said sleeve formed in a coil and with first and second ends adjacent the gap, and a hook means on the first end facing the second end, and first and second hook means on the second end facing the first end, and

wherein the step of locking the sleeve comprises engaging the hook means of said first end with the first hook means of the second end to expand the sleeve to a first diameter, and engaging the hook means of the first end with the second hook means of the second end to expand the sleeve to a second diameter.

26. The method of claim 25, and further including the step of opening the sleeve by expanding the sleeve so that its ends move beyond each other and collapsing the sleeve with the hook means of each sleeve end facing away from the opposite sleeve end.

28. A method of placement of a sleeve into an affected lumen of a human body for preventing re-stenosis following angioplasty of the affected lumen and maintaining at least a minimum opening in the lumen, comprising:

providing a radially collapsible sleeve formed in a mesh defining a plurality of openings that allow tissue to grow through the openings and a coating applied to the mesh for defining a plurality of openings that allow promotion of epithelialization, with said sleeve radially collapsed,

carrying the radially collapsed sleeve along the length of a lumen to a position in the lumen where the minimum opening in the lumen is to be established,

radially expanding the sleeve,

radially expanding the lumen in response to the expansion of the sleeve, and locking the sleeve in its radially expanded position, to promote epithelialization through the openings of the sleeve to promote incorporation of the stent into the vessel wall,

wherein the step of providing a radially collapsible sleeve comprises providing a sleeve having circumferential ribs protruding from the sleeve intermediate the ends of the sleeve, and the step of expanding the sleeve comprises expanding the protruding circumferential ribs into contact with the lumen, and retarding movement of the sleeve along the length of the lumen with engagement of the ribs with the lumen.

29. The method of claim 28, wherein the step of providing a radially collapsible sleeve formed in a mesh comprises providing a sleeve with a woven network with intersections connected together.

30. A method of placement of a sleeve into an affected lumen of a human body following angioplasty for preventing re-stenosis of the affected lumen and maintaining at least a minimum opening in the lumen comprising:

providing a sleeve formed in a mesh and a coating applied to said mesh and defining a plurality of openings throughout the mesh to allow tissue to grow there through,

providing a catheter,

mounting the sleeve in a radially collapsed position on the catheter,

inserting the catheter with the collapsed sleeve mounted thereon into a lumen of the body,

carrying the sleeve in its collapsed position with the catheter along the length of the lumen to a position in the lumen where the minimum opening in the lumen is to be maintained,

radially expanding the sleeve in the position of the lumen where the minimum opening in the lumen is to be maintained,

radially expanding the lumen in response to the radial expansion of the sleeve,

withdrawing the catheter from the sleeve and from the lumen,

promoting epithelialization of the lumen about the sleeve and its openings for incorporating the sleeve into the lumen, and

retarding re-stenosis of the lumen with the sleeve.

31. The method of claim 30, wherein the step of radially expanding the sleeve comprises expanding the sleeve to a predetermined circumference.

32. The method of claim 30, wherein the step of providing a sleeve comprises providing sleeve having circumferential ribs protruding from the sleeve intermediate the ends of the sleeve, and the step of expanding the sleeve comprises expanding the protruding circumferential ribs into contact with the lumen, and retarding movement of the sleeve along the length of the lumen with engagement of the ribs with the lumen.

33. The method of claim 30, wherein the step of providing a sleeve formed in a mesh and a coating applied to said mesh and defining a plurality of openings throughout the mesh to allow tissue to grow there through, includes the coating defining a plurality of openings and rounded surfaces for avoiding trauma to the lumen.

34. A stent for placement into a lumen of the human body and for maintaining an opening within the lumen, said stent comprising:

a radially collapsible sleeve formed in a mesh,

a coating of material applied to the mesh and defining a plurality of openings throughout the mesh to allow tissue to grow therethrough, and

said mesh being biased toward its collapsed position.

35. A stent as claimed in claim 34 wherein said mesh being biased toward its collapsed position comprises the memory of said sleeve.

36. A stent as claimed in claim 34 and further including locking means for fixing an expanded diameter of said sleeve.

37. A stent as claimed in claim 34 wherein said mesh being biased toward its collapsed position includes spring means embedded within said sleeve.

38. A stent as claimed in claim 34 wherein when said sleeve is in its collapsed position it is in the form of a coil, and when the sleeve is expanded it is in the form of a cylinder.

39. A stent for placement into a narrowed opening of a lumen of the human body and for maintaining at least a minimum opening within the lumen, said stent comprising:

a radially collapsible sleeve formed in a mesh and a coating applied thereto,

said sleeve defining a plurality of openings throughout the mesh to allow tissue to grow therethrough, and

said mesh being biased toward either its collapsed position or its expanded position.

40. A stent as claimed in claim 39, and further including a plurality of generally circumferential ribs protruding from said sleeve for engagement with the lumen and limiting movement of the sleeve in the lumen.

41. A stent as claimed in claim 39 wherein when said sleeve is in its expanded position it is in the form of a cylinder.

42. A stent as claimed in claim 39, wherein said mesh is a woven network with intersections connected together, and said coating is applied to said woven network.