Artificial silk reinforcement of PTCA balloon

• US 20050271844A1
• Filed: 06/07/2004
• Published: 12/08/2005
• Est. Priority Date: 06/07/2004
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Eramo, Lincoln, Mapes, Ken
• Application Number:
  US10/862,250
• Publication Number:
  US 20050271844A1
• Time in Patent Office: Days
• US Class Current: 428/36.100
• CPC Class Codes: A61L 29/048 Other specific proteins or polypeptides not covered by A61L29/045 - A61L29/047
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2255/02 on fibrous or filamentary layer
• CPC Class Codes: B32B 2262/08 Animal fibres, e.g. hair, wool, silk
• CPC Class Codes: B32B 2307/746 Slipping, anti-blocking, low friction
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 27/12 next to a fibrous or filamentary layer
• CPC Class Codes: B32B 5/24 one layer being a fibrous or filamentary layer
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: B32B 9/02 comprising animal or vegetable substances , e.g. cork, bamboo, starch
• CPC Class Codes: Y10T 428/1362 Textile, fabric, cloth, or pile containing [e.g., web, net, woven, knitted, mesh, nonwoven, matted, etc.]
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]

Abstract

A medical device formed from at least one first layer defining the shape of the medical device, the first layer having an inner surface and an outer surface and a web formed with silk fiber provided over at least a portion of the inner surface, the outer surface or both of the first layer.

Claims

1. A tubular member for a catheter assembly, the tubular member comprising:

a) a first layer having an inner surface and an outer surface defining the shape of the tubular member; and

b) a web formed with silk fiber having an inner surface and an outer surface, the web provided over at least a portion of said inner surface, said outer surface or both of said first layer.

2. The tubular member of claim 1 wherein said silk fiber is spun from recombinant silk proteins, from a silk producing member of the phylum Arthropoda or combination thereof.

3. The tubular member of claim 1 further comprising an adhesive composition on said silk fiber, on said tubular member or both.

4. The tubular member of claim 3, said adhesive composition comprising at least one of a thermoplastic composition, a thermosetting composition, or mixture thereof.

5. The tubular member of claim 1 further comprising a matrix material on said outer surface of said web, said matrix material substantially encapsulating said web.

6. The tubular member of claim 5, said matrix material comprising at least one member selected from the group consisting of spider silk proteins, thermosetting materials, thermoplastic materials, lubricious materials, therapeutic agents and combination thereof.

7. The tubular member of claim 1, said first layer comprising at least one polymeric material selected from the group consisting of polyesters, polyethers, polyamides, polyurethanes, polyolefins, styrenic block copolymers, and mixtures thereof.

8. The tubular member of claim 7 said first layer comprising at least one of polyethylene terephthalate, polybutylene terephthalate, poly (ether-block-amide), poly (ether-block-ester), poly (ester-block-ester) or mixtures thereof.

9. The tubular member of claim 1 wherein said tubular member is a catheter shaft, catheter tip, preform for an expandable balloon member or an expandable balloon member.

10. The tubular member of claim 1, said tubular member further comprising atherotomes.

11. A process for forming a tubular member for a catheter assembly, the process comprising the steps of:

a) providing a shape-form, the shape-form defining the shape of the tubular member; and

b) providing a web of silk fibers over said shape-form.

12. The process of claim 11 further comprising the step of substantially fixing said web of silk fibers to said shape-form.

13. The process of claim 11 wherein said shape-form defines the shape of an expandable medical balloon, a tubular preform for an expandable medical balloon, a catheter tip or a catheter shaft.

14. The process of claim 13 wherein said shape-form defines the shape of a tubular preform, said process further comprising the step of molding said tubular preform into said expandable member.

15. The process of claim 11 further comprising the step of applying a matrix material over said web.

16. The process of claim 11 further comprising the step of applying a coating comprising a friction reducing material to said fibers or to said shape-form.

17. The process of claim 11 wherein said shape-form is selected from the group consisting of polyesters, polyethers, polyamides, polyurethanes, polyolefins, styrenic block copolymers, or mixtures thereof.

18. The process of claim 11 wherein said shape-form is fluidizable or non-fluidizable, the process further comprising the step of eliminating said shape-form after said step of providing a web of silk fibers over said shape-form.

19. The process of claim 18, said web having an inner surface and an outer surface, the method further comprising the step of applying a matrix material to said inner surface of said web.

20. The process of claim 18 wherein said fluidizable shape-form is dissolvable or meltable.

21. The process of claim 18 wherein said fluidizable or non-fluidizable shape-form is a coil, spring, glass, starch, sugar, ice, polyvinyl alcohol, polyvinyl acetate or a combination thereof.

22. The process of claim 11, said tubular member is an expandable medical balloon having at least one expanded state, said expandable medical balloon is in an expanded state prior to application of said web.

23. The process of claim 11, said tubular member is an expandable medical balloon having at least one deflated state, said expandable medical balloon is in a deflated state prior to application of said web.

24. The process of claim 23 wherein said web is in the form of a sock.

25. The process of claim 24 further comprising the step of inflating said balloon after application of said web.

26. The process of claim 11 wherein said web is wrapped helically around said tubular member.

27. The process of claim 11 wherein said silk fibers are formed from recombinant spider silk protein.

28. The process of claim 11 wherein said matrix material is selected from the group consisting of recombinant spider silk protein, thermosetting materials, thermoplastic materials, lubricious materials, therapeutic agents, and mixtures thereof.

29. The process of claim 11 wherein said web is in the form of a braid, weave, rove, net, mesh, wrap or knit.

30. The process of claim 11, further comprising the step of providing atherotomes to said tubular member.

31. An expandable balloon member formed from a polymeric composition, said balloon member further reinforced with a fibrous material having a strength of at least about 40 g/d.

32. The expandable balloon member of claim 31 wherein the strength of the fibrous material is about 50 g/d to about 200 g/d.

33. An expandable member for a catheter assembly comprising a web of fibers, said expandable member defined by said web of fibers.

34. An expandable balloon member comprising a matrix material reinforced with fibers having a diameter of less than 12.