INFLATABLE MEDICAL DEVICES

• US 20090301643A1
• Filed: 06/02/2009
• Published: 12/10/2009
• Est. Priority Date: 06/02/2008
• Status: Active Grant

• Current Assignee: Loma Vista Medical, Inc. (Becton, Dickinson & Co)
• Original Assignee: Loma Vista Medical, Inc. (Becton, Dickinson & Co)
• Inventors: SCHEEFF, Mark Christopher, TILSON, Alexander Quillin
• Granted Patent: US 9,186,488 B2
• Time in Patent Office: Days
• US Class Current: 156/155
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: B29C 41/04 : Rotational or centrifugal casting, i.e. coating the inside of a mould by rotating the mould
• CPC Class Codes: B29C 41/14 : Dipping a core B29C41/10 takes precedence
• CPC Class Codes: Y10T 156/1028 : by bending, drawing or stretch forming sheet to assume shape of configured lamina while in contact therewith
• CPC Class Codes: Y10T 156/108 : Flash, trim or excess removal

Abstract

Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Claims

1. A method for making an inflatable device for use in a biological body comprising:

forming a leak-proof member from solid film on a removable mandrel.

2. The method of claim 1, wherein the inflatable device has no through lumen.

3. The method of claim 1, wherein the forming occurs at a temperature below 100°

Celsius.

4. The method of claim 1, wherein the forming occurs without solvation.

5. The method of claim 1, further comprising dissolving the mandrel with a fluid comprising water.

6. The method of claim 1, further comprising adhering the film to the mandrel, wherein adhering comprises adhering with a water-soluble tacking adhesive.

7. The method of claim 1, wherein the forming comprises pressure-forming.

8. The method of claim 1, further comprising trimming the film.

9. The method of claim 1, wherein the thermoset film comprises no fiber.

10. The method of claim 1, wherein the film comprises PEEK.

11. The method of claim 1, wherein the film comprises a film first piece and a film second piece, and wherein forming the film comprises a first forming and a second forming, wherein the first forming comprises forming the film first piece over a first part of the mandrel, and wherein the second forming comprises forming the film second piece of the film over a second part of the mandrel.

12. The method of claim 11, wherein the first part of the mandrel is about half the mandrel, and wherein the second part of the mandrel is about half the mandrel not defined by the first part of the mandrel.

13. The method of claim 11, further comprising bonding the film first piece to the second film piece.

14. The method of claim 1, wherein the inflatable device is leak-proof.

15. The method of claim 1, wherein the inflatable device has a wall thickness, and wherein the wall thickness is less than about 0.05 mm.

16. The method of claim 1, wherein the mandrel comprises a eutectic or non-eutectic bismuth.

17. The method of claim 1, wherein the mandrel comprises polyvinylacetate.

18. A method for making an inflatable device for use in a biological body comprising:

adhering with a first bonding agent a first film to a mandrel;

forming the first film on about the first half of the mandrel;

bonding with a second bonding agent the first film to a second film;

forming the second film on about the second half of the mandrel; and

dissolving the mandrel.

19. The method of claim 18, wherein dissolving comprises applying water to the mandrel.

20. The method of claim 18, wherein the first bonding agent is water soluble.

21. The method of claim 18, wherein the mandrel comprises a sugar.

22. The method of claim 18, wherein the mandrel comprises a plastic.

23. The method of claim 18, wherein the mandrel comprises a polylactic acid.

24. The method of claim 18, wherein the mandrel comprises a polyvinylacetate.

25. The method of claim 18, wherein the mandrel comprises a water-soluble wax.

26. A method for making an inflatable device for use in a biological body comprising:

positioning a solid film on a mandrel; and

dissolving the mandrel.

27. The method of claim 26, wherein dissolving comprises dissolving with water

28. The method of claim 26, wherein the mandrel comprises a sugar.

29. The method of claim 26, wherein the mandrel comprises a plastic.

30. The method of claim 26, wherein the mandrel comprises a polylactic acid.

31. The method of claim 26, wherein the mandrel comprises a polyvinylacetate.

32. The method of claim 26, wherein the mandrel comprises a water-soluble wax.

33. The method of claim 26, wherein the film is water-tight

34. The method of claim 26, wherein the film comprises a flat piece before forming on the mandrel.

35. A method for making an inflatable device for use in a biological body comprising:

positioning a film on a mandrel, wherein the mandrel comprises a plastic; and

dissolving the mandrel.

36. The method of claim 35, wherein dissolving comprises dissolving with water.

37. The method of claim 35, wherein the mandrel comprises a sugar.

38. The method of claim 35, wherein the mandrel comprises polylactic acid.

39. The method of claim 35, wherein the mandrel comprises polyvinylacetate.

40. The method of claim 35, wherein the mandrel comprises a water-soluble wax.

41. A method of making an inflatable device for use in a biological body comprising:

creating a first hole that transects a mandrel;

passing a fiber through the first hole;

forming a layer of material on the mandrel;

attaching the layer to the fiber; and

dissolving the mandrel.

42. The method of claim 41, wherein attaching comprises attaching the fiber to the side of the layer against the mandrel.

43. The method of claim 41, wherein attaching comprises attaching the fiber to the side of the layer away from the mandrel.

44. The method of claim 41, wherein attaching comprises attaching the fiber to the inside of the layer.