Resorbable containment device and process for making and using same

• US 20050209629A1
• Filed: 02/25/2005
• Published: 09/22/2005
• Est. Priority Date: 04/19/2001
• Status: Abandoned Application

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Kerr, Sean H., Dwyer, James W., Weikel, Stuart
• Application Number:
  US11/067,438
• Publication Number:
  US 20050209629A1
• 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 or resorptive
• 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 or non-slip
• CPC Class Codes: A61B 2017/00867 shape memory effect
• 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 a resorbable containment device for use in treating voids in bone and restoring the anatomy of diseased or fractured bone. The resorbable containment 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. The containment device may be formed from a pluronic based polymer and may degrade in-vivo within a period of weeks after implantation into 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. 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, the inner surface defining a space,

wherein the barrier member is capable of preventing fluid within the space from passing through the inner surface to the outer surface, and the barrier member comprises a polyurethane polymer based on at least one of the group consisting of capralactone and Pluronic, such that the barrier member is capable of degrading into biologically compatible substances in vivo.

2. The device of claim 1, wherein the flexible material comprises a plasticizer.

3. The device of claim 2, wherein the flexible material is a resorbable material.

4. The device of claim 3, wherein the flexible material has high elongation.

5. The device of claim 1, wherein the flexible material has an elongation at break of between about 1,000-percent and about 2,000-percent.

6. The device of claim 1, wherein the flexible material has a Young'"'"'s modulus between about 10 MPa and about 100 MPa.

7. The device of claim 1, wherein the flexible material has a tensile strength at break between about 5 to about 100 MPa.

8. The device of claim 1, wherein the barrier member comprises a plurality of layers.

9. The device of claim 8, wherein the barrier member has a tensile strength between about 15 and about 50 MPa.

10. The device of claim 9, wherein the barrier member has a tensile strength between about 25 MPa and about 35 MPa.

11. The device of claim 8, wherein the barrier member has a Young'"'"'s modulus of between about 5 MPa and about 30 MPa.

12. The device of claim 11, wherein the barrier member has a Young'"'"'s modulus of between about 15 MPa and about 25 MPa.

13. The device of claim 11, wherein the barrier member has an elongation at break of between about 600-percent and 1000-percent.

14. The device of claim 13, wherein the barrier member has an elongation at break of between about 850-percent and 950-percent.

15. The device of claim 13, wherein the barrier member has an average molecular weight of between about 100,000 and about 200,000 dalton.

16. The device of claim 15, wherein the barrier member has an average molecular weight of between about 150,000 and about 190,000 dalton.

17. The device of claim 1, wherein the barrier member has mass and the mass degrades in vivo after the device is implanted into bone.

18. The device of claim 17, wherein more than about 60-percent of the mass degrades after about 2 weeks of in vivo degradation.

19. The device of claim 18, wherein the barrier member has a thickness of about 0.5 mm.

20. The device of claim 19, wherein the mass degrades in vivo to produce carbon dioxide, water and diamine.

21. A method of forming a resorbable containment device comprising:

providing a mold;

providing a polymer;

depositing a plurality of layers of the polymer on the mold to form the resorbable containment device; and

removing the resorbable containment device from the mold.

22. The method of claim 21 further comprising treating the mold with at least one lubricating material to provide a lubricating barrier for facilitating removal of the resorbable containment device from the mold.

23. The method of claim 22 further comprising spraying the mold with the at least one lubricating material.

24. The method of claim 22 further comprising dip coating the mold in at least one lubricating material.

25. The method of claim 21 further comprising positioning at least one strand on the mold.

26. The method of claim 25 further comprising forming a woven member with the at least one strand.

27. The method of claim 21 further comprising positioning at least one strand on one of a partially and completely formed resorbable containment device.

28. The method of claim 21 further comprising:

positioning at least one strand on a partially formed resorbable containment device; and

depositing additional polymer over the at least one strand.

29. The method of claim 21 further comprising forming the mold of stainless steel and polishing the stainless steel.

30. The method of claim 21 further comprising forming the mold of PTFE.

31. The method of claim 21, wherein the step of depositing a plurality of layers of the polymer on the mold comprises solution casting.