Methods, materials and apparatus for treating bone and other tissue

• US 8,540,722 B2
• Filed: 06/16/2009
• Issued: 09/24/2013
• Est. Priority Date: 06/17/2003
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Beyar, Mordechay, Globerman, Oren, Domb, Abraham, Shavit, Ronen, Wachsler-Avrahami, Hila
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US12/485,098
• Publication Number:
  US 20090264942A1
• Time in Patent Office: 1,561 Days
• Field of Search: 606 92- 94
• US Class Current: 606/94
• 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) inserting a delivery device into an interior of a vertebra;

(b) introducing bone cement through the delivery device and into the vertebra without an enclosure between the bone cement and the vertebra; and

(c) manipulating the delivery device, as the bone cement flows through the delivery device, to change an introduction direction of the bone cement;

wherein a sufficient amount of bone cement is delivered to the interior of the vertebra with sufficient force to move apart fractured portions of the vertebra.

2. A method according to claim 1, wherein the bone cement sets to a hardened condition after introduction into the body.

3. A method according to claim 1, wherein the bone cement does not set to a hardened condition in storage.

4. A method according to claim 1, wherein the bone cement is a viscous fluid.

5. A method according to claim 4, wherein the bone cement has a viscosity between 600 Pascal-second and 1,800 Pascal-second.

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

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

8. A method according to claim 1, wherein the delivery device has a diameter of less than 6 mm and a length of at least 70 mm.

9. A method according to claim 1, wherein the bone cement is introduced through an extrusion aperture formed in the delivery device and having a minimum dimension of less than 3 mm.

10. A method according to claim 1, wherein the bone cement is introduced through an extrusion aperture formed in the delivery device and having a minimum dimension of less than 1.5 mm.

11. A method according to claim 1, wherein introducing comprises introducing the bone cement through a plurality of extrusion apertures simultaneously, the plurality of extrusion apertures being formed in the delivery device.

12. A method according to claim 1, further comprising manipulating the delivery device to change an introduction position of the bone cement.

13. A method according to claim 1, wherein introducing comprises advancing the bone cement using a motor.

14. A method according to claim 1, wherein introducing comprises advancing the bone cement using a hydraulic source.

15. A method according to claim 1, wherein introducing comprises introducing the bone cement in discrete unit amounts.

16. A method according to claim 15, wherein at least some of the units have different mechanical properties from each other.

17. A method according to claim 1, wherein introducing comprises cutting the bone cement away from the delivery device.

18. A method according to claim 1, wherein introducing comprises not twisting the delivery device during said introducing.

19. A method according to claim 1, wherein introducing comprises shaping an extrusion form of the bone cement using an exit aperture formed in the delivery device.

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

21. 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.

27. The method according to claim 1, further comprising inserting a cannula into a body, and inserting the delivery device through the cannula prior to introducing the bone cement.

28. The method according to claim 1, wherein manipulating the delivery device comprises rotating the delivery device as the bone cement flows into the vertebra.

29. The method according to claim 1, further comprising removing the delivery device from a first access hole formed in the vertebra and inserting the delivery device through a second access hole formed in the vertebra.

30. The method according to claim 29, further comprising introducing the bone cement while the delivery device is positioned in the second access hole.

31. The method according to claim 1, further comprising inflating a balloon to create a cavity in the vertebra prior to inserting the delivery device into the vertebra.

34. The method according to claim 12, wherein manipulating comprises moving the delivery device axially to direct the bone cement to a desired location in the vertebra.

22. A method of treating bone, comprising:

(a) inserting a delivery device into an interior of a bone; and

(b) introducing bone cement into the bone through a plurality of extrusion apertures formed in the delivery device, without a separate void forming act and without an enclosure between the cement and the bone, and with sufficient force to move apart fractured portions of the bone.

23. A method according to claim 22, comprising leaving the bone cement in said bone to resist at least 30% of a normative force which urges said portions together.

24. A method according to claim 22, wherein said bone is a vertebra.

25. A method according to claim 24, wherein the bone cement does not set to a hardened condition in storage.

26. The method according to claim 22, wherein the delivery device comprises a cannula.

32. The method according to claim 22, further comprising manipulating the delivery device to change an introduction position of the bone cement.

33. The method according to claim 32, wherein manipulating comprises moving the delivery device axially to direct the bone cement to a desired location in the bone.

35. A method of treating a vertebra, comprising:

(a) inserting a delivery device into an interior of a vertebra; and

(b) introducing bone cement through the delivery device and into the vertebra without a separate void forming act and without an enclosure between the bone cement and the vertebra;

wherein a sufficient amount of bone cement is delivered to the interior of the vertebra with sufficient force to move apart fractured portions of the vertebra.

36. The method according to claim 35, wherein manipulating the delivery device comprises rotating the delivery device as the bone cement flows into the vertebra.

37. The method according to claim 35, wherein manipulating comprises moving the delivery device axially to direct the bone cement to a desired location in the bone.

38. The method according to claim 35, wherein introducing comprises advancing the bone cement using a motor.

39. The method according to claim 35, wherein introducing comprises advancing the bone cement using a hydraulic source.

40. The method according to claim 35, wherein the bone cement is a viscous fluid.

41. The method according to claim 35, wherein the bone cement has a viscosity between 600 Pascal-second and 1,800 Pascal-second.

42. The method according to claim 35, wherein introducing comprises introducing at a pressure of at least 40 atmospheres.

43. The method according to claim 35, wherein introducing comprises introducing at a pressure of at least 100 atmospheres.

44. The method according to claim 35, wherein introducing comprises introducing the bone cement through at least one extrusion aperture formed in a sidewall of the delivery device.