Methods of Distracting Tissue Layers of the Human Spine

• US 20070055273A1
• Filed: 08/15/2006
• Published: 03/08/2007
• Est. Priority Date: 08/16/2005
• Status: Active Grant

• Current Assignee: IZI Medical Products LLC (Halma PLC)
• Original Assignee: Benvenue Medical, Inc. (Halma PLC)
• Inventors: Schaller, Laurent
• Granted Patent: US 7,670,374 B2
• Time in Patent Office: Days
• US Class Current: 606/90
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30263 cubical
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• 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 2002/4683 : by applying ultrasonic vibrations
• CPC Class Codes: A61F 2002/4688 : having operating or control means
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0084 : cubical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite

Abstract

Methods of separating and/or supporting layers of tissue in the human spine. Such methods generally comprise inserting at least a distal end portion of a guide member between layers of tissue in the human spine wherein the distal end portion defines a predetermined shape. A distraction device is advanced over at least the distal end portion of the guide member so that the distraction device substantially assumes the predetermined shape of the distal end portion of the guide member to form a support structure between the tissue layers that separates and/or supports the tissue layers.

Claims

1. A method of treating the human spine, comprising:

inserting at least a distal end portion of a guide member between layers of tissue in the human spine, said distal end portion defining a predetermined shape; and

advancing an elongated member over at least the distal end portion of the guide member so that the elongated member substantially assumes the predetermined shape of the distal end portion of the guide member to form a support structure between the tissue layers that separates, supports or both separates and supports the tissue layers.

2. The method of claim 1 in which the inserting comprises inserting the distal end portion of the guide member through a cannula to between the layers of tissue.

3. The method of claim 2 further including removing the cannula prior to advancing the elongated member over the distal end portion of the guide member.

4. The method of claim 1 further including removing the guide member from the elongated member after the support structure is formed.

5. The method of claim 1 further including severing the guide member after the support structure is formed.

6. The method of claim 1 in which the guide member has a pre-deployed configuration for insertion of at least the distal end portion of the guide member between the tissue layers and a deployed configuration in which the distal end portion defines the pre-determined shape between the tissue layers;

and

further including changing the configuration of the distal end portion from the pre-deployed configuration to the deployed configuration.

7. The method of claim 6 in which the pre-deployed configuration is generally linear.

8. The method of claim 6 in which changing the configuration of the distal end portion of the guide member results from a self-forming of the distal end portion into the predetermined shape.

9. The method of claim 8 in which at least the distal end portion of the guide member is comprised of a shape memory material.

10. The method of claim 1 further including inserting filler material or therapeutic drugs into or around the support structure.

11. The method of claim 1 in which the guide member is inserted between the tissue layers under the influence of ultrasonic vibrations.

12. The method of claim 1 in which the pre-determined shape is spiral or helical.

13. A method of treating the human spine, comprising:

inserting at least a distal end portion of a guide member between layers of tissue in the human spine, said distal end portion defining a multi-tiered shape; and

advancing a distraction device over at least the distal end portion of the guide member so that the distraction device substantially assumes the multi-tiered shape and forms a multi-tiered support structure that separates, supports or both separates and supports the tissue layers.

14. The method of claim 13 in which the inserting comprises inserting the distal end portion of the guide member through a cannula to between the layers of tissue.

15. The method of claim 14 further including removing the cannula prior to advancing the distraction device over the distal end portion of the guide member.

16. The method of claim 13 further including removing the guide member from the distraction device after the support structure is formed.

17. The method of claim 13 further including severing the guide member after the support structure is formed.

18. The method of claim 13 in which the guide member has a pre-deployed configuration for insertion of at least the distal end portion of the guide member between the tissue layers and a deployed configuration in which the distal end portion defines the multi-tiered shape between the tissue layers;

and

further including changing the configuration of the distal end portion from the pre-deployed configuration to the deployed configuration.

19. The method of claim 18 in which the pre-deployed configuration is generally linear.

20. The method of claim 18 in which changing the configuration of the distal end portion of the guide member results from a self-forming of the distal end portion into the multi-tiered shape.

21. The method of claim 20 in which at least the distal end portion of the guide member is comprised of a shape memory material.

22. The method of claim 13 in which the multi-tiered shape is helical.

23. The method of claim 13 in which the distraction device comprises an elongated member.

24. The method of claim 13 in which the distraction device comprises a plurality of individual distraction device elements.

25. The method of claim 13 in which the guide member is inserted between the tissue layers under the influence of ultrasonic vibrations.

26. A method of treating a vertebral body, comprising:

inserting at least a distal end portion of a guide member into the vertebral body, said distal end portion having a pre-determined shape; and

advancing a distraction device over at least the distal end portion of the guide member so that the distraction device substantially assumes the pre-determined shape of the distal end portion of the guide member to form a support structure that separates, supports or both separates and supports the superior endplate and inferior endplate.

27. The method of claim 26 in which the inserting comprises inserting the distal end portion of the guide member through a cannula into the vertebral body.

28. The method of claim 27 further including removing the cannula prior to advancing the distraction device over the distal end portion of the guide member.

29. The method of claim 26 further including removing the guide member from the distraction device after the support structure is formed.

30. The method of claim 26 further including severing the guide member after the support structure is formed.

31. The method of claim 26 in which the guide member has a pre-deployed configuration for insertion of at least the distal end portion of the guide member into the vertebral body and a deployed configuration in which the distal end portion defines the pre-determined shape within the vertebral body;

and

further including changing the configuration of the distal end portion from the pre-deployed configuration to the deployed configuration.

32. The method of claim 31 in which the pre-deployed configuration is generally linear.

33. The method of claim 31 in which changing the configuration of the distal end portion of the guide member results from a self-forming of the distal end portion into the predetermined shape.

34. The method of claim 33 in which at least the distal end portion of the guide member is comprised of a shape memory material.

35. The method of claim 26 in which the guide member is inserted into the vertebral body under the influence of ultrasonic vibrations.

36. The method of claim 26 in which the pre-determined shape is spiral or helical.

37. The method of claim 26 in which the distraction device comprises an elongated member.

38. The method of claim 26 in which the distraction device comprising a plurality of individual distraction device elements.

39. The method of claim 26 further including inserting bone filler or therapeutic drugs into or around the support structure.

40. A method of treating a vertebra, comprising:

inserting at least a distal end portion of a guide member between a superior vertebra and an inferior vertebra, said distal end portion having a multi-tiered shape; and

advancing a distraction device over at least the distal end portion of the guide member so that the distraction device substantially assumes the multi-tiered shape of the distal end portion of the guide member and forms a multi-tiered support structure that separates, supports or both separates and supports the superior vertebra and inferior vertebra.

41. The method of claim 40 in which the inserting comprises inserting the distal end portion of the guide member through a cannula to between the superior vertebra and inferior vertebra.

42. The method of claim 40 further including removing the cannula prior to advancing the distraction device over the distal end portion of the guide member.

43. The method of claim 40 further including removing the guide member from the distraction device after the support structure has been formed.

44. The method of claim 40 further including severing the guide member after the support structure is formed.

45. The method of claim 40 in which the guide member has a pre-deployed configuration for insertion of at least the distal end portion of the guide member between the superior and inferior vertebrae and a deployed configuration in which the distal end portion defines the multi-tiered shape between the superior and inferior vertebrae;

and

further including changing the configuration of the distal end portion from the pre-deployed configuration to the deployed configuration.

46. The method of claim 45 in which the pre-deployed configuration is generally linear.

47. The method of claim 45 in which changing the configuration of the distal end portion of the guide member results from a self-forming of the distal end portion into the multi-tiered shape.

48. The method of claim 47 in which at least the distal end portion of the guide member is comprised of a shape memory material.

49. The method of claim 40 in which the multi-tiered shape is helical.

50. The method of claim 40 in which the guide member is inserted between the superior and inferior vertebrae under the influence of ultrasonic vibrations.

51. The method of claim 40 in which the distraction device comprises an elongated member.

52. The method of claim 40 in which the distraction device comprises a plurality of individual distraction device elements.

53. The method of claim 40 further including inserting bone filler or therapeutic drugs into or around the support structure.

54. A method of treating a vertebral body, comprising:

inserting a distal end portion of a guide member into a vertebral body;

changing the configuration of the distal end portion of the guide member into a coil-shape having a plurality of stacked windings; and

advancing a distraction device over at least the distal end portion of the guide member so that the distraction device substantially forms a coil-shaped support structure that separates, supports or both separates and supports the opposed endplates of the vertebral body.

55. The method of claim 54 in which the inserting comprises inserting the distal end portion of the guide member through a cannula into the vertebral body.

56. The method of claim 55 further including removing the cannula prior to advancing the distraction device over the distal end portion of the guide member.

57. The method of claim 54 further including removing the guide member from the distraction device after the support structure has been formed.

58. The method of claim 54 further including severing the guide member after the support structure is formed.

59. The method of claim 54 in which the distraction device comprising an elongated member.

60. The method of claim 54 in which the distraction device comprising a plurality of individual distraction device elements.

61. The method of claim 54 further including inserting bone filler or therapeutic drugs into or around the support structure.

62. The method of claim 54 in which the pre-deployed configuration is generally linear.

63. The method of claim 54 in which changing the configuration of the distal end portion of the guide member results from a self-forming of the distal end portion into the coil shape.

64. The method of claim 63 in which at least the distal end portion of the guide member is comprised of a shape memory material.

65. The method of claim 54 in which the guide member is inserted into the vertebral body under the influence of ultrasonic vibrations.