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1. WO2006011152 - METHODS FOR TREATING BONE AND OTHER TISSUE

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[ EN ]

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 1OA shore and I OOA shore.

1 1 . 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. A surgical set comprising:
at least one tool adapted to deliver a material into a vertebra; and
at least Ice of artificial biocompatible prepared material that does not set to a hardened condition outside the body.

41. A set according to claim 40, wherein said at least one tool comprises a pressure delivery mechanism capable of delivering said material at a pressure of above 100 atmospheres.

42. A set according to claim 40, wherein said set comprises a disposable hydraulic actuator.

43. A set according to claim 40, wherein said set comprises a replaceable magazine for storing said material.

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 IOOA Shore into said vertebra, with sufficient force to move apart fractured portions of said bone.

50. A surgical set comprising:
at least one tool adapted to deliver a material into a vertebra; and
at least Ice of biocompatible prepared material that has a Young modulus of less than 120% of healthy vertebral trabecular bone and is prepared at least 1 day ahead of time.

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 1OA shore and softer than I OOA shore.

52. Apparatus for delivering a material or an implant into a bone, comprising:
(a) a delivery tube having a lumen and a distal end adapted for insertion into a body;
(b) a payload comprising at least one of material and an implant inside said lumen;

(c) a lining disposed between said tube and said payload; and
(d) an advancing mechanism adapted to move said liner and said payload to said distal end,
wherein said liner reduces a friction of said payload against said delivery tube.

53. Apparatus according to claim 52, comprising a splitter which splits said sleeve.

54. Apparatus according to claim 52, wherein said mechanism pulls said sleeve.

55. Apparatus according to claim 52, wherein said mechanism pushes said payload.

56. Apparatus according to claim 52, wherein said sleeve folds over said delivery tube.

57. A biocompatible material which does not set to a hardened condition and does not include cross-linking of a type greater than type I and formed of MMA (methyl methacrylate).

58. A material according to claim 57, wherein said material is formed of a mixture of MMA and LMA (lauryl methacrylate)

59. A second medical use of PMMA for height restoration of vertebral bones when applied directly into a vertebra.

60. A second medical use according to claim 59, wherein said PMMA is applied during setting while at a viscosity higher than 400 Pascal-second.

61 . A second medical use of bone putty for vertebral treatment when applied under pressure through a tubular delivery system into a vertebral bone.

62. A polymerizing composition, comprising:
(a) a first quantity of beads having a set of sizes ; and
(b) a second quantity of monomer,
wherein said quantities are selected so that a mixture of said quantities results in a setting material having a workability window of at least 5 minutes at a viscosity between 500 and 2000 Pascal-second.

63. A method of treating bone, comprising providing a heat source into a vertebra in a controlled manner.

64. A composite tool for accessing bone, comprising:
an elongate body having:
(a) a head adapted to penetrate bone;
(b) an aperture adapted to extrude material into bone, near said head; and
(c) a lumen adapted to deliver material to said aperture; and
a source of material under pressure.

65. A tool according to claim 64, comprising a lumen for a guidewire.

66. A composite tool for accessing bone comprising:
a drill tool including a lumen;
a separable guidewire adapted to fit in said lumen; and
a handle adapted to control the relative positions of said drill tool and said guidewire.