Biodegradable mesh and film stent

• US 5,629,077 A
• Filed: 06/27/1994
• Issued: 05/13/1997
• Est. Priority Date: 06/27/1994
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Turnlund, Todd H., Eury, Robert P.
• Primary Examiner(s): Bell, James J.
• Application Number:
  US08/266,964
• Time in Patent Office: 1,051 Days
• Field of Search: 428/109, 428/110, 428/225, 428/229, 428/247, 428/255, 428/257, 428/258, 428/259, 428/296, 156/308.2, 604/8, 623/1
• 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 laminated fibrous mesh, comprising:

a woven mesh layer having first and second sides, said woven mesh layer being formed from a plurality of fibers of a first biodegradable polymer, said plurality of fibers of said first biodegradable polymer being heat bonded together with a second biodegradable polymer, said second biodegradable polymer melting at a temperature lower than said first biodegradable polymer; and

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

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

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

6. The mesh 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 method of making a biodegradable laminated fibrous mesh, comprising the steps of:

forming a woven mesh of a plurality of fibers of a first biodegradable polymer heat bonded together with a second biodegradable polymer, said second biodegradable polymer melting at a temperature lower than said first biodegradable polymer; and

laminating the woven mesh with at least one laminating film to melt the second low temperature melting biodegradable polymer at a temperature of from about 120°

to about 330°

F. to form a woven mesh and film laminate.

8. The method of claim 7, wherein said step of forming a woven mesh comprises coweaving a fiber of said first biodegradable polymer and a fiber of said second lower temperature melting biodegradable polymer.

9. The method of claim 7, wherein said step of forming a woven mesh comprises coweaving said plurality of fibers of said first biodegradable polymer and a plurality of fibers of said second low temperature melting biodegradable polymer.

10. The method of claim 9, wherein said step of coweaving comprises coweaving pairs of said fibers of said first biodegradable polymer and said fibers of said second lower temperature melting biodegradable polymer in a plain weave pattern.

11. The method of claim 7, wherein said step of forming a woven mesh comprises commingling said plurality of fibers of said first biodegradable polymer and a plurality of fibers of said second lower temperature melting biodegradable polymer to form a plurality of commingled fibers of said first and second polymers, and weaving said commingled fibers in a woven mesh.

12. The method of claim 7, wherein said step of forming a woven mesh comprises coating said plurality of fibers of said first biodegradable polymer with said second low temperature melting biodegradable polymer, and weaving a woven mesh of said plurality of said first biodegradable polymeric fibers coated with said second low temperature melting biodegradable polymer.

13. The method of claim 7, wherein said step of laminating said woven mesh is carried out at a temperature of from about 180°

to about 270°

F.