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

• US 20020177866A1
• Filed: 07/20/2001
• Published: 11/28/2002
• 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 6,632,235 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.

30. The method of claim 29, wherein the second component is a woven braid.

31. The method of claim 30, wherein the woven braid forms a predetermined shape.

32. The method of claim 29, further comprising the step of applying a sealant to the treated area prior to deployment of the inflatable device.

33. The method of claim 32, wherein the step of applying the sealant to the treated area comprises spray coating.

34. The method of claim 32, wherein the step of applying the sealant further comprises:

applying the sealant as a gel;

at least partially inflating the inflatable device within the treated area;

using the inflatable device to spread the sealant onto the treated area.

35. The method of claim 34, wherein the step of using the inflatable device to spread the sealant comprises rotating the inflatable device.

36. The method of claim 34, wherein the step of using the inflatable device to spread the sealant comprises moving the device along an axis in which the device is deployed into the treated area.

37. The method of claim 34, further comprising the step of gradually inflating the inflatable device while spreading the sealant onto the treated area.

29. A method for treating bone comprising:

creating a cavity in the treated area of the bone;

deploying an inflatable device inside the bone, said inflatable device having 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.