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

• US 7,666,205 B2
• Filed: 08/08/2003
• Issued: 02/23/2010
• Est. Priority Date: 04/19/2001
• Status: Active Grant

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Weikel, Stuart, Paul, David C.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Nguyen; Tuan V
• Application Number:
  US10/636,549
• Publication Number:
  US 20040098015A1
• Time in Patent Office: 2,391 Days
• Field of Search: 606/60, 606/94, 606/192, 606/61, 606/72, 606/76, 606/86, 606/191, 606/92, 606/194, 606/198, 623/17, 623/23.19, 623/23.2, 604/103.01
• 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 a first component forming a barrier configured and adapted for insertion into bone, the barrier having a proximal end and a distal end, a longitudinal axis and inner and outer surfaces, the proximal end of the barrier being secured to a distal end of a catheter and the distal end of the barrier, upon inflation, extending away from the distal end of the catheter such that the longitudinal axis of the barrier is substantially parallel to a longitudinal axis of the catheter, the inner surface defining an enclosure having a port to receive filler material, the outer surface configured to contact and substantially conform to the surface of the bone, the barrier having an insertion configuration for placement in a bone cavity and an expanded configuration providing the enclosure to receive the filler material without releasing the filler material into the bone cavity;

wherein the barrier includes at least one rupture site configured to fail under a triggering condition, such that the expanded configuration of the barrier has a first condition which contains the filler material within the enclosure and a second condition which releases the filler material from the enclosure upon failure of the at least one rupture site due to the triggering condition;

wherein the at least one rupture site includes a plurality predetermined seams configured to fail under the triggering condition, the plurality of predetermined seams running parallel to the longitudinal axis of the barrier and originating from the distal end of the barrier and ending at the proximal end of the barrier, and the predetermined seams configured to fail so that, after the triggering condition has occurred, the barrier resembles an open banana peel; and

wherein at least one of the plurality of predetermined seams are resorbable.

2. The inflatable device of claim 1, wherein the device comprises a second component and 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 2, 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 outer surface of the barrier.

10. The inflatable device of claim 8, wherein the medicament is disposed on an inner surface of the barrier.

11. The inflatable device of claim 2, 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 device comprises a second component that 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 the outer 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 hydrophilic 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 the outer surface of the first component.

22. The inflatable device of claim 1, wherein the first component is perforated.

23. The inflatable device of claim 1, wherein the triggering condition comprises a chemical concentration proximate to one of the inner and outer surfaces of the barrier.

24. The inflatable device of claim 1, wherein the one or more predetermined seams define a region of the barrier.

25. A device for containing material inside bone comprising:

a barrier member configured and adapted for insertion into bone, the barrier member having a proximal end and a distal end, a longitudinal axis and inner and outer surfaces, the proximal end of the barrier being secured to a distal end of a catheter and the distal end of the barrier, upon inflation, extending away from the distal end of the catheter such that the longitudinal axis of the barrier is substantially parallel to a longitudinal axis of the catheter, with the inner surface defining a space, the barrier having an insertion configuration for placement in a bone cavity and an expanded configuration providing the space to receive filler material without releasing the filler material into the bone cavity;

wherein the barrier includes at least one rupture site configured to fail under a triggering condition; and

wherein in a first configuration of the expanded configuration the barrier member prevents material within the space from passing through the inner surface to the outer surface, and in a second configuration of the expanded configuration the barrier member opens to release material from within the space to the outer surface of the barrier member upon failure of the at least one rupture site due to the triggering condition;

wherein the at least one rupture site includes a single predetermined seam configured to fail under the triggering condition, the predetermined seam originating at a distal end of the barrier and having a generally spiral configuration about the longitudinal axis of the barrier so that, after the triggering condition has occurred, the barrier resembles an orange peel; and

wherein the predetermined seam is resorbable.

26. The device of claim 25, wherein the predetermined seam is configured and adapted to open when the triggering condition occurs.

27. The device of claim 26, wherein the triggering condition comprises a chemical concentration proximate the inner surface of the barrier member.

28. The device of claim 26, wherein the triggering condition comprises a chemical concentration proximate the outer surface of the barrier member.

29. The device of claim 25, wherein each rupture site is pressure-sensitive.

30. A device for containing material inside bone comprising:

a flexible member configured and adapted for insertion into bone, the flexible member having a proximal end and a distal end, inner and outer surfaces, a longitudinal axis and a plurality of predetermined seams, with the inner surface defining a substantially enclosed space, the proximal end of the barrier being secured to a distal end of a catheter and the distal end of the barrier, upon inflation, extending away from the distal end of the catheter such that the longitudinal axis of the barrier is substantially parallel to a longitudinal axis of the catheter; and

a flowable substance disposed in the space;

wherein the flexible member is expanded under pressure to reduce a fracture in bone and wherein in a first configuration the flexible member resists migration of the flowable material through the inner surface, and in a second configuration the flexible member opens to release material through the inner surface to the outer surface of the flexible member upon rupturing of the seam under a triggering condition;

wherein the plurality of predetermined seams run parallel to the longitudinal axis of the flexible member and originate from the distal end of the flexible member and end at the proximal end of the flexible member, and the predetermined seams configured to fail so that, after the triggering condition has occurred, the barrier resembles an open banana peel; and

wherein at least one of the plurality of predetermined seams are resorbable.

31. The device of claim 30, wherein at least one of the plurality of predetermined seams are pressure-sensitive.

32. The device of claim 30, wherein at least one of the plurality of predetermined seams are chemical-sensitive.