Methods, Materials and Apparatus for Treating Bone and Other Tissue

• US 20090264942A1
• Filed: 06/16/2009
• Published: 10/22/2009
• Est. Priority Date: 06/17/2003
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Inventors: Beyar, Mordechay, Globerman, Oren, Wachsler-Avrahami, Hila, Shavit, Ronen, Domb, Abraham
• Granted Patent: US 8,540,722 B2
• Time in Patent Office: Days
• US Class Current: 606/86.R
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: B01F 27/1143 screw-shaped, e.g. worms
• CPC Class Codes: B01F 33/86 Mixing heads comprising a driven stirrer
• CPC Class Codes: B01F 35/123 using scrapers for cleaning mixers
• CPC Class Codes: B01F 35/531 with baffles, plates or bars on the wall or the bottom
• CPC Class Codes: B01F 35/754251 reciprocating in the mixing receptacle
• CPC Class Codes: C08L 33/10 Homopolymers or copolymers of methacrylic acid esters

Abstract

A method of treating a vertebra, comprising:

• • (a) accessing an interior of a vertebra; and
  • (b) introducing a sufficient amount of artificial biocompatible material which does not set to a hardened condition in storage, into said bone, with sufficient force to move apart fractured portions of said bone.

Claims

1. A method of treating a vertebra, comprising:

(a) accessing an interior of a vertebra; and

(b) introducing a sufficient amount of artificial biocompatible material which does not set to a hardened condition in storage, into said bone, with sufficient force to move apart fractured portions of said bone.

2. A method according to claim 1, wherein said material does not set to a hardened condition after introduction into the body.

3. A method according to claim 1, wherein said material can be stored for over 1 day.

4. A method according to claim 1, wherein said material softens after implantation.

5. A method according to claim 1, wherein said material partly hardens after implantation.

6. A method according to claim 1, wherein said material does set to a hardened condition after introduction into the body.

7. A method according to claim 1, wherein said material does not set to a hardened condition in storage.

8. A method according to claim 1, wherein said material is artificial.

9. A method according to claim 1, wherein said material is a plastically deforming material.

10. A method according to claim 9, wherein said material has a hardness of between 10 A shore and 100 A shore.

11. A method according to claim 10, wherein said material is free of cross-linking higher than type I.

12. A method according to claim 10, wherein said material is thermoplastic.

13. A method according to claim 10, wherein said material comprises LMA (lauryl methacrylate) and MMA (methyl methacrylate).

14. A method according to claim 1, wherein said material is a viscous fluid.

15. A method according to claim 14, wherein said material has a viscosity between 600 Pascal-second and 1,800 Pascal-second.

16. A method according to claim 1, wherein introducing comprises introducing at a pressure of at least 40 atmospheres.

17. A method according to claim 1, wherein introducing comprises introducing at a pressure of at least 100 atmospheres.

18. A method according to claim 1, wherein introducing comprises introducing through a delivery channel having a diameter of less than 6 mm and a length of at least 70 mm.

19. A method according to claim 1, wherein introducing comprises introducing through an extrusion aperture having a minimum dimension of less than 3 mm.

20. A method according to claim 1, wherein introducing comprises introducing through an extrusion aperture having a minimum dimension of less than 1.5 mm.

21. A method according to claim 1, wherein introducing comprises introducing through a plurality of extrusion apertures simultaneously.

22. A method according to claim 1, wherein introducing comprises changing an introduction direction during said introduction.

23. A method according to claim 1, wherein introducing comprises changing an introduction position during said introduction.

24. A method according to claim 1, wherein said material comprises at least one material adapted to function in a capacity other than structural support.

25. A method according to claim 1, wherein introducing comprises advancing said material using a motor.

26. A method according to claim 1, wherein introducing comprises advancing said material using a hydraulic source.

27. A method according to claim 1, wherein introducing comprises introducing said material in discrete unit amounts.

28. A method according to claim 27, wherein at least some of the units have different mechanical properties form each other.

29. A method according to claim 1, wherein introducing comprises cutting said material away from a delivery system.

30. A method according to claim 1, wherein introducing comprises not twisting said material during said introducing.

31. A method according to claim 1, wherein introducing comprises shaping an extrusion form of said material using an exit aperture.

32. A method according to claim 1, wherein accessing comprises accessing using a guidewire and providing a delivery system over the guidewire.

33. A method according to claim 1, wherein accessing comprises accessing using a delivery system of said material.

34. A method according to claim 1, wherein introducing comprises introducing without a separate void forming act.

35. A method according to claim 1, wherein introducing comprises introducing without a spatially constraining enclosure.

36. A method according to claim 1, wherein introducing comprises introducing in a spatially constraining enclosure.

37. A method according to claim 1, wherein introducing comprises also introducing at least 10% by volume of a material which sets to a hardened condition.

38. A method according to claim 1, comprising selecting said material to have at least one of hardness and Young modulus properties less than those of trabecular bone of said vertebra, after a week from said implantation.

39. A method according to claim 1, wherein said introduced material is operative to support at least 30% of a weight of vertebra within a week after implantation.

40-43. -43. (canceled)

44. A method of treating bone, comprising:

(a) accessing an interior of a bone; and

(b) introducing a sufficient amount of biocompatible material into said bone, without an enclosure between said material and the bone, said introducing being with sufficient force to move apart fractured portions of said bone.

45. A method according to claim 44, comprising leaving said material in said bone to resist at least 30% of a normative force which urges said portions together.

46. A method according to claim 44, wherein said bone is a vertebra.

47. A method according to claim 46, wherein said material does not set to a hardened condition in storage.

48. A method according to claim 46, wherein said material does not set to a hardened condition in the body.

49. A method of treating a vertebra, comprising:

(a) accessing an interior of a vertebra; and

(b) introducing a sufficient amount of spatially unconstrained biocompatible soft material having a hardness of less than 100 A Shore into said vertebra, with sufficient force to move apart fractured portions of said bone.

50. (canceled)

51. A method of treating a bone, comprising:

(a) accessing an interior of a bone; and

(b) introducing, via a delivery tube, into said bone an unconstrained plastically deformable solid material harder than 10 A shore and softer than 100 A shore.

52-66. -66. (canceled)