Biodegradable mesh and film stent

• US 5,766,710 A
• Filed: 06/19/1996
• Issued: 06/16/1998
• Est. Priority Date: 06/27/1994
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Turnlund, Todd Hanson, Eury, Robert Paul
• Primary Examiner(s): Bell, James J.
• Application Number:
  US08/666,755
• Time in Patent Office: 727 Days
• Field of Search: 623/1, 623/DIG. 900, 604/8, 156/218, 156/308.2, 156/309.6, 156/148, 442/38, 428/36.1, 428/36.3
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: B32B 2367/00 Polyesters, e.g. PET, i.e. polyethylene terephthalate
• CPC Class Codes: B32B 37/04 characterised by the partial melting of at least one layer
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10T 156/1038 Hollow cylinder article
• CPC Class Codes: Y10T 428/1369 Fiber or fibers wound around each other or into a self-sustaining shape [e.g., yarn, braid, fibers shaped around a core, etc.]
• CPC Class Codes: Y10T 442/164 Including a preformed film, foil, or sheet

Abstract

The biodegradable mesh and film stent for use in blood vessels is formed of a sheet of a composite mesh material formed of biodegradable high strength polymer fibers bonded together with a second biodegradable adhesive polymer, and laminated on at least one side with a thin film of a third biodegradable polymer. The biodegradable mesh and film material is formed as a sheet and cut in a shape that can be used as a stent, such as a "belt-buckle" type shape, the ends of which can be joined in a contractible, expandable loop. In the method of making the biodegradable composite mesh and film stent, the composite mesh is preferably formed from a weave formed of high strength biodegradable polymeric fibers, and a plurality of low temperature melting biodegradable polymeric fibers. In an alternate embodiment, the high strength fibers are commingled with the low temperature melting fibers. In another alternate embodiment, the high strength fibers are coated with the low temperature melting polymer. The composite mesh is covered on at least one side by a laminating film, and is then cut into the shape of the stent.

Claims

1. A biodegradable mesh and film stent for use in maintaining the patency of blood vessels, said stent comprising:

a mesh layer having first and second sides, formed from a plurality of fibers of a first biodegradable polymer, said plurality of fibers being heat bonded together with a second biodegradable polymer;

at least one layer of a film of a biodegradable polymer bonded to said mesh layer on at least one side of said mesh layer to form a sheet of biodegradable mesh and film material;

said sheet of biodegradable mesh and film material having first and second ends and a main body portion between said first and second ends, said sheet of biodegradable mesh and film material being rolled up into a cylindrical configuration whereby said first end overlaps said second end.

2. The stent of claim 1, wherein said first biodegradable polymer is selected from the group consisting of polyglycolic acid, poly-L-lactic acid, polyorthoesters, polyanhydrides, polyiminocarbonates, and inorganic calcium phosphate.

3. The stent of claim 1, wherein said second biodegradable polymer is selected from the group consisting of polycaprolactone, poly-DL-lactic acid, a combination of poly-L-lactic acid and polycaprolactone, polyorthoesters, aliphatic polycarbonates, polyphosphazenes, and combinations thereof.

4. The stent of claim 1, wherein said mesh layer of fibers of a first biodegradable polymer has a weave density of from about 10 to about 200 fibers per inch.

5. The stent of claim 1, wherein said mesh layer is laminated with a layer of film on both sides to encapsulate the mesh.

6. The stent of claim 1, wherein said laminating layer of film is formed from a biodegradable polymer selected from the group consisting of poly-DL-lactic acid and poly-L-lactic acid.

7. A biodegradable mesh and film stent for use in maintaining the patency of blood vessels, said stent comprising:

a mesh layer having first and second sides, formed from a plurality of fibers of a first biodegradable polymer, said plurality of fibers being heat bonded together with a second biodegradable polymer;

at least one layer of a film of a biodegradable polymer bonded to said mesh layer on at least one side of said mesh layer to form a sheet of biodegradable mesh and film material;

said sheet of biodegradable mesh and film material having first and second ends and a main body portion between said first and second ends, said first end having a surface defining a slot for receiving said second end, said second end and said main body portion being insertable through said slot so as to form a loop, said second end having means for retaining said second end inserted in said slot, and said main body portion having means for releasably engaging said slot to adjustably retain said main body portion in said slot.

8. The stent of claim 7, wherein said first biodegradable polymer is selected from the group consisting of polyglycolic acid, poly-L-lactic acid, polyorthoesters, polyanhydrides, polyiminocarbonates, and inorganic calcium phosphate.

9. The stent of claim 7, wherein said second biodegradable polymer is selected from the group consisting of polycaprolactone, poly-DL-lactic acid, a combination of poly-L-lactic acid and polycaprolactone, polyorthoesters, aliphatic polycarbonates, polyphosphazenes, and combinations thereof.

10. The stent of claim 7, wherein said mesh layer of fibers of a first biodegradable polymer has a weave density of from about 10 to about 200 fibers per inch.

11. The stent of claim 7 wherein said mesh layer is laminated with a layer of film on both sides to encapsulate the mesh.

12. The stent of claim 7 wherein said laminating layer of film is formed from a biodegradable polymer selected from the group consisting of poly-DL-lactic acid and poly-L-lactic acid.

13. The stent of claim 7 wherein said means for retaining said second end inserted in said slot comprises a widened portion of said second end.

14. The stent of claim 7, wherein said main body portion includes first and second side edges, and said means in said main body portion for releasably engaging said slot to adjustably retain said main body portion in said slot comprises a plurality of serrations along each side edge of the main body portion dimensioned to provide a firm interference fit in the slot.

15. A method of making a biodegradable mesh and film stent for use in maintaining the patency of blood vessels, comprising the steps of:

forming a sheet of biodegradable mesh and film material from a plurality of fibers of a first biodegradable polymer and a second biodegradable polymer, said second biodegradable polymer melting at a lower temperature than the first biodegradable polymer;

placing at least one laminating film of a biodegradable polymer, on at least one side of said mesh;

heating said laminating film and mesh to melt said second biodegradable polymer and form a mesh and film laminate; and

cutting the sheet of biodegradable mesh and film material in a shape to form said stent, said stent being formed to include first and second ends and a main body portion between said first and second ends; and

rolling said sheet of biodegradable mesh and film material into a cylindrical configuration whereby said first end overlaps said second end.

16. The method of claim 15, wherein said mesh and film are heated to a temperature of from about 120°

to about 330°

F.

17. The method of claim 15, wherein said mesh and film are heated to a temperature of from about 180°

to about 270°

F.

18. The method of claim 15, wherein said step of forming a mesh comprises coweaving a fiber of said first biodegradable polymer with a fiber of said second relatively lower temperature melting biodegradable polymer.

19. The method of claim 18, wherein said step of forming a mesh comprises coweaving a plurality of said fibers of said first biodegradable polymer and a plurality of fibers of said second relatively lower temperature melting biodegradable polymer.

20. The method of claim 19 wherein said step of coweaving comprises coweaving pairs of said first biodegradable polymeric fiber and said fibers of said second low temperature melting biodegradable polymer in a plain weave pattern.

21. The method of claim 15, wherein said step of forming a mesh comprises commingling said plurality of said first biodegradable polymeric fibers and a plurality of fibers of said second low temperature, melting biodegradable polymer to form a plurality of commingled fibers of said first and second polymers, and weaving said commingled fibers in a mesh.

22. The method of claim 15, wherein said step of forming a mesh comprises coating said plurality of fibers of said first biodegradable polymer with said second low temperature melting biodegradable polymer, and weaving a mesh of said plurality of said first biodegradable polymeric fibers coated with said second low temperature melting biodegradable polymer.

23. The method of claim 15, wherein said step of forming a mesh comprises coating a plurality of individual fibers of said first biodegradable polymer with said second lower temperature melting biodegradable polymer to form a plurality of individually coated fibers of said first biodegradable polymer, and weaving a mesh of said plurality of individually coated fibers of said first biodegradable polymer.

24. The method of claim 15, wherein said step of cutting said sheet of biodegradable mesh and film material comprises cutting said mesh and film laminate with a laser.

25. A method of making a biodegradable mesh and film stent for use in maintaining the patency of blood vessels, comprising the steps of:

forming a mesh of a plurality of fibers of a first biodegradable polymer and a second biodegradable polymer, said second biodegradable polymer melting at a lower temperature than the first biodegradable polymer;

placing at least one laminating film of a biodegradable on at least one side of said mesh;

heating said laminating film and mesh to melt said second biodegradable polymer and form a mesh and film laminate; and

cutting the mesh and film laminate in a shape to form said stent, said stent being formed to include first and second ends and a main body portion between said first and second ends, said first end having a surface defining a slot for receiving said second end, said second end and said main body portion being formed to be insertable through said slot so as to form a loop, said second end being formed to include means for retaining said second end inserted in said slot, and said main body portion being formed to have means for releasably engaging said slot to adjustably retain said main body portion in said slot.

26. The method of claim 25, wherein said laminating film and mesh are heated to a temperature of from about 120°

to about 330°

F.

27. The method of claim 25, wherein said step of laminating said mesh is carried out at a temperature of from about 180°

to about 270°

F.

28. The method of claim 25, wherein said step of forming a mesh comprises coweaving a fiber of said first biodegradable polymer with a fiber of said second relatively lower temperature melting biodegradable polymer.

29. The method of claim 28, wherein said step of forming a mesh comprises coweaving a plurality of said fibers of said first biodegradable polymer and a plurality of fibers of said second relatively lower temperature melting biodegradable polymer.

30. The method of claim 29, wherein said step of coweaving comprises coweaving pairs of said first biodegradable polymeric fiber and said fibers of said second low temperature melting biodegradable polymer in a plain weave pattern.

31. The method of claim 25, wherein said step of forming a mesh comprises commingling said plurality of said first biodegradable polymeric fibers and a plurality of fibers of said second low temperature melting biodegradable polymer to form a plurality of commingled fibers of said first and second polymers, and weaving said commingled fibers in a mesh.

32. The method of claim 25, wherein said step of forming a mesh comprises coating said plurality of fibers of said first biodegradable polymer with said second low temperature melting biodegradable polymer, and weaving a mesh of said plurality of said first biodegradable polymeric fibers coated with said second low temperature melting biodegradable polymer.

33. The method of claim 25, wherein said step of forming a mesh comprises coating a plurality of individual fibers of said first biodegradable polymer with said second lower temperature melting biodegradable polymer to form a plurality of individually coated fibers of said first biodegradable polymer, and weaving a mesh of said plurality of individually coated fibers of said first biodegradable polymer.

34. The method of claim 25 wherein said step of cutting said mesh and film laminate comprises cutting said mesh and film laminate with a laser.