SYSTEMS FOR TREATING BONE

• US 20070233250A1
• Filed: 02/07/2007
• Published: 10/04/2007
• Est. Priority Date: 02/07/2006
• Status: Abandoned Application

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Shadduck, John
• Application Number:
  US11/672,434
• Publication Number:
  US 20070233250A1
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment

Abstract

The present invention relates in certain embodiments to medical devices for treating vertebral compression fractures. In one embodiment, the invention relate to systems for introducing fill material into a vertebral body that slowly expands vertebral height without explosive balloon expansion as in kyphoplasty. The system provides a fill material that infills a vertebra without flowable bone cement as used in kyphoplasty and vertebropalsty procedures. Thus, the bone fill system prevents the possibility of extravasation of material into the spinal canal which occurs in a significant number of kyphoplasty and vertebropalsty procedures. An energy source can apply energy to a substantially rigid implant material in order to soften, melt, or fracture the implant material to infill a vertebral body.

Claims

1. A system for treating a bone, comprising:

an elongated introducer configured for insertion in a bone, the introducer defining a passage extending therethrough along an axis of the introducer;

an elongated implant body configured for insertion through the passage into the bone, the elongated implant body having a substantially unyielding configuration; and

an energy source coupled to the elongated introducer, the energy source configured to transform at least a portion of the elongated implant into a yielding configuration to infill the bone.

2. The system of claim 1, wherein the energy source is at least one of an Rf energy source, a resistive heat source, a light energy source, a microwave energy source, an ultrasound energy source, a magnetic energy source, a mechanical energy source and a cryogenic source.

3. The system of claim 2, wherein the energy source is configured to cause at least one of softening, melting, cutting, sacrificing and fracturing said at least one portion of the implant body.

4. The system of claim 1, wherein the energy source comprises at least one energy emitter disposed proximate a distal end of the introducer, the at least one emitter configured to direct thermal energy to at least a portion of the elongated implant.

5. The system of claim 2, wherein the mechanical source comprises an implant drive mechanism and an opening formed on a side of the elongated introducer, said opening configured to fracture at least a portion of the elongated implant as the implant is advanced through the introducer.

6. The system of claim 2, wherein the mechanical source comprises an implant drive mechanism and at least one cutting element coupled to the introducer, said at least one cutting element configured to cut at least a portion of the elongated implant as the implant is advanced through the introducer.

7. The system of claim 1, wherein the energy source is a cryogenic source configured to be coupled to the introducer, the cryogenic source configured to fragment at least a portion of the elongated implant as the implant is advanced through the introducer.

8. The system of claim 1, further comprising a controller in communication with the energy source, the controller configured to control the application of energy by the energy source to at least a portion of the elongated implant.

9. The system of claim 1, wherein the elongated implant body has a helical configuration, the implant body configured to be helically driven through the introducer.

10. The system of claim 9, wherein the elongated implant body comprises a plurality of implant elements, wherein adjacent implant elements are coupled to each other via keys on said adjacent elements.

11. The system of claim 1, wherein the elongated implant body comprises a plurality of helically intertwined portions.

12. The system of claim 1, wherein the elongated implant body comprises a plurality of implant elements, wherein adjacent implant elements are coupled with each other via a sacrificial portion, said energy source configured to effect at least one of fracturing, melting, dissolving and fragmenting of said sacrificial portion.

13. The system of claim 1, wherein the elongated implant body defines a passage therethrough configured to allow a flow of bone fill material therethrough for introduction into the bone.

14. A system for treating a vertebra, comprising:

an elongated introducer configured for insertion in a vertebral body, the introducer defining a passage extending therethrough along an axis of the introducer;

a substantially rigid implant configured for insertion through the passage into the vertebral body, the implant comprising a plurality of implant elements coupled with each other via a junction, the junction transformable between a substantially unyielding configuration to a substantially yielding configuration; and

an energy source coupled to the elongated introducer, the energy source configured to separate at least one implant element from the implant at said junction, the separated implant element advanced into the vertebral body to infill the vertebral body.

15. The system of claim 14, wherein the energy source is at least one of an Rf energy source, a resistive heat source, a light energy source, a microwave energy source, an ultrasound energy source, a magnetic energy source, a mechanical energy source and a cryogenic source.

16. The system of claim 15, wherein the energy source is configured to direct thermal energy to at least said junction to melt said junction to separate the implant element from the substantially rigid implant.

17. The system of claim 14, wherein the energy source is a mechanical source comprising an implant drive mechanism and a member configured to effect at least one of cutting, fracturing and sacrificing of said junction to separate said implant element from the substantially rigid implant.

18. The system of claim 14, wherein the substantially rigid implant has a helical configuration.

19. The system of claim 14, wherein the substantially rigid implant defines a passage therethrough along an axis of the substantially rigid implant, said passage dimensioned to allow a flow of bone fill material therethrough for insertion into the vertebral body.

20. A system for the infill of the interior of a bone, comprising:

an elongated introducer configured for introduction into a bone, the introducer defining a passage extending therethrough along an axis of the introducer;

a plurality of implants dimensioned for advancement along the introducer, each adjacent pair of the plurality of implants coupled to each other via a junction, each implant having a first helical feature for cooperating with a second helical feature on the introducer to helically advance the implants through the passage and into the bone.

21. The system of claim 20, wherein the implants are keyed with one another.

22. The system of claim 20, wherein the implants are coupled to one another via a sacrificial portion.

23. The system of claim 22 further comprising an energy source configured to detach at least one of the plurality of implants proximate said sacrificial portion.

24. A system for treating a bone, comprising:

an elongated introducer configured for insertion into a bone, the introducer defining a passage extending therethrough along an axis of the introducer;

an elongated implant body configured for insertion into the bone along said introducer, the elongated implant body having a substantially unyielding configuration, a surface of the implant body configured to engage with a surface of the introducer for advancement of the implant body along the introducer; and

means for transforming at least a portion of the elongated implant from a substantially unyielding configuration to a yielding configuration to infill the bone.

25. An implant configured for insertion into a bone, comprising:

an elongated body sized for introduction along an introducer into a bone, at least a portion of the elongated body being transformable from a substantially unyielding configuration to a yielding configuration configured for infilling the bone.

26. The implant of claim 25, wherein the elongated body comprises at least one of a polymeric material, a ceramic material, a glass material or a combination thereof.

27. The implant of claim 26, wherein the material is biocompatible.

28. The implant of claim 26, wherein the material comprises PMMA.

29. The implant of claim 25, wherein the elongated body defines a passage therethrough along an axis thereof, the passage configured for insertion of bone cement therethrough into the bone.

30. The implant of claim 25, wherein the elongated body has a helical feature configured to engage a corresponding feature on the introducer.

31. The implant of claim 30, wherein the helical feature is formed on an outer surface of the elongated body.

32. The implant of claim 30, wherein the helical feature is formed on an inner surface of the elongated body.

33. The implant of claim 25, wherein the elongated body comprises a plurality of implant elements and adjacent implant elements are coupled to each other via a junction.

34. The implant of claim 33, wherein the junction is a sacrificial junction.

35. The implant of claim 33, wherein at least one element is severable from an adjacent element proximate said junction via the application of at least one of thermal energy, mechanical energy and cryogenic cooling.

36. The implant of claim 35, wherein thermal energy is applied by at least one of an Rf source, a resistive heat source, a light energy source, a microwave source, an ultrasound source, a magnetic source and a cryogenic source.

37. The implant of claim 33, wherein the junction comprises interlocking key features formed on adjacent implant elements.

38. An implant configured for insertion into a bone, comprising:

an elongated body having at least one helical feature and sized for introduction into a bone, at least a portion of the elongated body being severable from the elongated portion for infilling the bone.

39. The implant of claim 38, wherein the elongated body comprises a plurality of implant elements, adjacent implant elements coupled to each other via a junction.

40. The implant of claim 39, wherein the junction comprises interlocking key features formed on adjacent implant elements.

41. The implant of claim 39, wherein the junction comprises a sacrificial portion.

42. The implant of claim 38, wherein the elongated body defines a passage therethrough along an axis thereof, the passage configured for insertion of bone cement therethrough into the bone.

43. The implant of claim 38, wherein the at least one helical feature is formed on an outer surface of the elongated body, the helical feature configured for engagement with a corresponding feature on an introducer through which the elongated body is advanced into the bone.

44. The implant of claim 38, wherein the at least one helical feature is formed on an inner surface of the elongated body, the helical feature configured for engagement with a corresponding feature on a shaft along which the elongated body is advanced into the bone.