Methods of distracting tissue layers of the human spine

• US 7,670,374 B2
• Filed: 08/15/2006
• Issued: 03/02/2010
• 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
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US11/464,812
• Publication Number:
  US 20070055273A1
• Time in Patent Office: 1,295 Days
• Field of Search: 606/90, 606/92, 606/105, 623 1711- 1716
• US Class Current: 623/17.11
• 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 a human vertebral body having an interior region defined by a superior endplate, an inferior endplate and a cortical rim, and containing cancellous bone therewithin, the method comprising:

inserting at least a distal end portion of an elongated guide member in a pre-deployed configuration into the vertebral body;

changing the configuration of the distal end portion of the guide member into a deployed configuration to define a pre-determined shape within the interior region of the vertebral body while leaving substantially undisturbed a portion of cancellous bone; and

slidably advancing an elongated intravertebral implant distally along the distal end portion of the guide member, the intravertebral implant having a guide lumen extending therethrough for slidably receiving the guide member so that the intravertebral implant may be longitudinally slidable on the guide member, the intravertebral implant being sufficiently flexible to substantially assume the pre-determined shape of the distal end portion of the guide member to form a support structure within the interior region of the vertebral body, which support structure includes a resident volume containing substantially undisturbed cancellous bone, and has a vertical extent sufficient to separate, support or both separate and support the superior and inferior endplates.

2. The method of claim 1 in which the inserting comprises inserting the distal end portion of the guide member through a cannula into the vertebral body.

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

4. The method of claim 1 further including removing the guide member from the intravertebral implant 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 pre-deployed configuration of the guide member is generally linear.

7. The method of claim 1 in which the distal end portion of the guide member is predisposed to form itself into the predetermined shape.

8. The method of claim 7 in which at least the distal end portion of the guide member is comprised of a shape memory material.

9. The method of claim 1 in which the guide member is inserted into the vertebral body under the influence of ultrasonic vibrations.

10. The method of claim 1 in which the pre-determined shape of the distal end portion of the guide member in the deployed configuration is spiral or helical.

11. The method of claim 1 in which the intravertebral implant comprises an elongated member of polymeric material.

12. The method of claim 1 further including inserting bone filler or a therapeutic drug into or around the support structure.