Apparatus and method for the in-situ formation of a structural prosthesis

• US 6,932,843 B2
• Filed: 09/25/2002
• Issued: 08/23/2005
• Est. Priority Date: 09/25/2002
• Status: Expired due to Term

• Current Assignee: Medicinelodge, Inc (Nelso Antolotti)
• Original Assignee: Medicinelodge, Inc (Nelso Antolotti)
• Inventors: Smith, Stephen A., Fallin, T. Wade
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US10/255,161
• Publication Number:
  US 20040059417A1
• Time in Patent Office: 1,063 Days
• Field of Search: 623/17.11, 623/17.12, 623/17.16, 606/92, 606/94, 606/61, 606/86, 606/87, 606/88, 606/93
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30561 breakable or frangible
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite

Abstract

An apparatus for in-situ formation of a structural prosthesis includes a tubular member having a proximal end and an opposing distal end. A balloon having a compartment is disposed on the tubular member such that a curable biomaterial can be selectively delivered to the compartment of the balloon through the tubular member. A line is disposed on or in the wall of the balloon to facilitate at least partial severing of the wall of the balloon after the biomaterial has at least partially cured therein such that the balloon can be selectively removed from around the at least partially curedbiomaterial, thereby forming a structural prosthesis.

Claims

1. An apparatus for in-situ formation of a structural prosthesis, the apparatus comprising:

a tubular member having a proximal end and an opposing distal end;

a balloon comprising a wall bounding a compartment, the balloon being coupled with the tubular member such that the tubular member communicates with the compartment of the balloon;

a curable biomaterial disposed within the compartment of the balloon; and

means for severing at least a portion of the wall of the balloon after the biomaterial has at least partially cured therein such that the balloon can be selectively removed from around the at least partially cured biomaterial.

2. An apparatus as recited in claim 1, wherein the tubular member comprises a catheter.

3. An apparatus as recited in claim 1, wherein the tubular member comprises a rigid tubular shaft.

4. An apparatus as recited in claim 1, wherein the balloon is integrally formed with or is connected to the tubular member.

5. An apparatus as recited in claim 1, wherein the means for at least partially severing the wall of the balloon comprises a line disposed on the wall of the balloon such that pulling on the line causes the line to at least partially sever the wall of the balloon.

6. An apparatus as recited in claim 1, wherein the means for at least partially severing the wall of the balloon comprises a line disposed on the wall of the balloon such that heating or vibrating the line causes the line to at least partially sever the wall of the balloon.

7. An apparatus for in-situ formation of a structural prosthesis, the apparatus comprising:

a tubular member having a proximal end and an opposing distal end with a passageway extending therebetween;

a balloon comprising a wall bounding a compartment, the balloon being permanently fixed to the tubular member with the passageway of the tubular member being in fluid communication with the compartment of the balloon; and

a line mounted on the wall of the balloon, to facilitate at least partial severing of the wall of the balloon.

8. An apparatus as recited in claim 7, wherein at least a portion of the line is embedded within the wall of the balloon.

9. An apparatus as recited in claim 7, wherein at least a portion of the line is secured against the wall of the balloon.

10. An apparatus as recited in claim 7, wherein the line is a wire comprised of metal.

11. An apparatus as recited in claim 7, wherein the line is comprised of a polymer.

12. An apparatus as recited in claim 7, wherein the line has a cutting edge formed thereon.

13. An apparatus as recited in claim 7, wherein the tubular member comprises a catheter.

14. An apparatus as recited in claim 7, wherein the tubular member comprises a rigid tubular shaft.

15. An apparatus as recited in claim 7, wherein the balloon is integrally formed with or is connected to the tubular member.

16. A method for forming a structural prosthesis within an intervertebral disc, the method comprising:

inserting at least a portion of a balloon within a site of an intervertebral disc;

at least partially filling the balloon within the site of the intervertebral disc with a biomaterial;

allowing the biomaterial to at least partially cure; and

removing the balloon from around the at least partially cured biomaterial within the site of the intervertebral disc.

17. A method as recited in claim 16, further comprising resecting at least a portion of the nucleus pulposus of the intervertebral disc prior to inserting the balloon.

18. A method as recited in claim 17, further comprising resecting at least a portion of the annulus fibrosus of the intervertebral disc prior to inserting the balloon.

19. A method as recited in claim 16, wherein the act of at least partially filling the balloon with a biomaterial comprises at least partially filling the balloon with a hydrogel or polyurethane.

20. A method as recited in claim 16, wherein the act of at least partially filling the balloon with a biomaterial comprises at least partially filling the balloon with calcium phosphate, calcium sulfate, acrylic, carbonate, or combinations thereof.

21. A method as recited in claim 16, wherein the act removing the balloon comprises at least partially severing a wall of the balloon.

22. A method as recited in claim 21, wherein the act of at least partially severing the wall of the balloon comprises cutting or tearing a portion of the wall of the balloon.

23. A method as recited in claim 21, wherein the act of at least partially severing the wall of the balloon comprises melting a portion of the wall of the balloon.

24. A method comprising:

inserting at least a portion of a balloon within a vertebral body;

at least partially filling the balloon within the vertebral body with a biomaterial;

allowing the biomaterial to at least partially cure; and

removing the balloon from around the at least partially cured biomaterial within the vertebral body.

25. A method as recited in claim 24, wherein the act of at least partially filling the balloon with a biomaterial comprises at least partially filling the balloon with calcium phosphate, calcium sulfate, acrylic, carbonate, or combinations thereof.

26. A method as recited in claim 24, wherein the act removing the balloon comprises at least partially severing a wall of the balloon.

27. A method as recited in claim 26, wherein the act of at least partially severing the wall of the balloon comprises cutting or tearing the wall of the balloon.

28. A method as recited in claim 26, wherein the act of at least partially severing the wall of the balloon comprises melting a portion of the wall of the balloon.

29. An apparatus for in-situ formation of a structural prosthesis, the apparatus comprising:

a balloon comprising a wall having an interior surface bounding a compartment, the balloon having a perimeter length;

a tubular member-having a passageway extending therethrough, the tubular member begin coupled with the balloon so that the passageway of the tubular member is in fluid communication with the compartment of the balloon; and

a line having a first portion continuously embedded within the wall of the balloon or continuously mounted on the interior surface of the balloon over a distance of at least half the perimeter length of the balloon.

30. An apparatus as recited in claim 29, wherein the line has a second portion longitudinally extending within the passageway of the tube.

31. An apparatus as recited in claim 30, wherein the tubular member has a length and the second portion of the line has a length greater than or equal to the length of the tube.

32. An apparatus as recited in claim 29, wherein the tubular member has a length and the line has a second portion disposed outside of the balloon, the second portion of the line having a length greater than or equal to the length of the tube.

33. An apparatus as recited in claim 29, wherein the tubular member comprises a rigid tubular shaft.

34. An apparatus for in-situ formation of a structural prosthesis, the apparatus comprising:

a balloon comprising a wall bounding a compartment;

a substantially rigid tubular member having a passageway extending therethrough, the tubular member being coupled with the balloon so that the passageway of the tubular member is in fluid communication with the compartment of the balloon; and

a line mounted on the wall of the balloon to facilitate at least partial severing of the wall of the balloon.

35. An apparatus as recited in claim 34, wherein at least a portion of the line is embedded within the wall of the balloon.

36. An apparatus as recited in claim 34, wherein the line is a wire comprised of metal.

37. An apparatus as recited in claim 34, wherein the balloon is movable between a first deflated position wherein at least a portion of the balloon is disposed within the passageway of the tubular member and a second inflated position wherein at least a portion of the balloon is disposed outside of the passageway of the tubular member.

38. An apparatus as recited in claim 34, wherein the tubular member is slidably disposed within a cannula.

39. An apparatus as recited in claim 34, further comprising a curable biomaterial disposed within the compartment of the balloon.

40. An apparatus for in-situ formation of a structural prosthesis, the apparatus comprising:

a balloon comprising a wall bounding a compartment;

a tubular member having a passageway extending therethrough, the tubular member begin coupled with the balloon so that the passageway of the tubular member is in fluid communication with the compartment of the balloon, at least a portion of the balloon being disposed within the passageway tubular member; and

a line mounted on the wall of the balloon to facilitate at least partial severing of the wall of the balloon.

41. An apparatus as recited in claim 40, wherein the tubular member is rigid.

42. An apparatus as recited in claim 40, wherein at least a portion of the line is embedded within the wall of the balloon.