Inflatable device and method for reducing fractures in bone and in treating the spine

• US 20040098015A1
• Filed: 08/08/2003
• Published: 05/20/2004
• Est. Priority Date: 04/19/2001
• Status: Active Grant

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Paul, David C., Weikel, Stuart
• Granted Patent: US 7,666,205 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0084 low friction A61B2017/00853 takes precedence
• CPC Class Codes: A61B 2017/00858 high friction, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30561 breakable or frangible
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00389 : The prosthesis being coated or covered with a particular material
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

The present invention is directed to an inflatable device for use in restoring the anatomy of diseased or fractured bone. The inflatable device may be a balloon of varied size or shape to conform to the bone to be treated and may be deployed in any type of bone where collapsed fractures of cortical bone may be treated by restoring the bone from its inner surface. Once the bone has been sufficiently restored the balloons may be deflated and removed, or may remain inside the bone. The balloon may have multiple layers to provide desired surface characteristics, resistance to puncture and tearing, or other beneficial properties, as appropriate for the particular application of the device.

Claims

1. An inflatable device for treating bone comprising first and second components, wherein the first component is a barrier that forms a balloon wall and the second component comprises a thread for reinforcing the wall, and wherein the second component is molded onto the first component.

2. The inflatable device of claim 1, wherein the second component is a woven braid.

3. The inflatable device of claim 2, wherein the woven braid forms a predetermined shape.

4. The inflatable device of claim 1, wherein the first component comprises an essentially inelastic material.

5. The inflatable device of claim 1, wherein the first component comprises an essentially semi-elastic material.

6. The inflatable device of claim 1, wherein the first component comprises an essentially elastic material.

7. The inflatable device of claim 1, wherein the second component comprises an essentially inelastic material.

8. The inflatable device of claim 1, further comprising a medicament.

9. The inflatable device of claim 8, wherein the medicament is disposed on an exterior surface of the balloon wall.

10. The inflatable device of claim 8, wherein the medicament is disposed on an interior surface of the balloon wall.

11. The inflatable device of claim 1, wherein the second component is at least partially resorbable.

12. The inflatable device of claim 1, wherein the first component is at least partially resorbable.

13. The inflatable device of claim 12, wherein the second component is at least partially resorbable.

14. The inflatable device of claim 12, wherein the first component further comprises a medicament that can be released as the first component is resorbed.

15. The inflatable device of claim 1, further comprising a coating on an exterior surface of the first component.

16. The inflatable device of claim 15, wherein the coating comprises a layer of hydrophobic material.

17. The inflatable device of claim 15, wherein the coating comprises a layer of hydrophillic material.

18. The inflatable device of claim 15, wherein the coating comprises a layer of material having a high friction surface.

19. The inflatable device of claim 15, wherein the coating comprises a layer of material having a low friction surface.

20. The inflatable device of claim 15, wherein the coating is resorbable.

21. The inflatable device of claim 15, wherein the coating covers essentially all of an exterior surface of the first component.

22. The inflatable device of claim 1, wherein the inflatable device is operably designed and configured to receive a filler material.

23. The inflatable device of claim 22, wherein the first component is operably designed and configured to lyse.

24. The inflatable device of claim 22, wherein at least one seam within the first and second components is operably designed and configured to fail under a triggering condition.

25. The inflatable device of claim 24, wherein the triggering condition is a pressure deferential between first and second sides of the balloon wall.

26. The inflatable device of claim 24, wherein the triggering condition comprises a chemical concentration proximate to a first side of the balloon wall.

27. The inflatable device of claim 24, wherein the at least one seam is resorbable.

28. The inflatable device of claim 24, wherein the at least one seam defines a region of the balloon wall.

29. A device for containing material inside bone comprising:

a barrier member configured and adapted for insertion into bone, the barrier member having inner and outer surfaces, with the inner surface defining a space,

wherein in a first configuration the barrier member prevents material within the space from passing through the inner surface to the outer surface, and in a second configuration the barrier member opens to release material from within the space to the outer surface of the barrier member.

30. The device of claim 29, wherein the barrier member opens at one or more rupture sites.

31. The device of claim 30, wherein each rupture site is located at a predetermined location on the barrier member.

32. The device of claim 31, wherein each rupture site comprises a seam in the barrier member.

33. The device of claim 32, wherein the seam is generally aligned with a longitudinal axis of the barrier member.

34. The device of claim 32, wherein the seam forms a generally spiral configuration about a longitudinal axis of the barrier member.

35. The device of claim 32, wherein portions of the seam intersect each other in at least one location.

36. The device of claim 32, wherein each rupture site is configured and adapted to open when a triggering condition occurs.

37. The device of claim 36, wherein the triggering condition is a pressure deferential between inner and outer surfaces of the barrier member.

38. The device of claim 36, wherein the triggering condition comprises a chemical concentration proximate the inner surface of the barrier member.

39. The device of claim 36, wherein the triggering condition comprises a chemical concentration proximate the outer surface of the barrier member.

40. The device of claim 32, wherein each rupture site is pressure-sensitive.

41. A device for containing material inside bone comprising:

a flexible member configured and adapted for insertion into bone, the flexible member having inner and outer surfaces, with the inner surface defining a substantially enclosed space; and

a flowable substance disposed in the space;

wherein the flexible member is formed of a resorbable material for being resorbed in vivo, and wherein the flexible member resists migration of the flowable material through the inner surface.

42. The device of claim 41, wherein the flexible member further comprises a seam.

43. The device of claim 42, wherein the seam is pressure-sensitive.

44. The device of claim 42, wherein the seam is chemical-sensitive.