Spinal tissue distraction devices

• US 7,666,226 B2
• Filed: 08/15/2006
• Issued: 02/23/2010
• 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:
  US11/464,790
• Publication Number:
  US 20070055272A1
• Time in Patent Office: 1,288 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 for prostheses A61F2210/0014
• 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

Spinal tissue distraction devices that include at least one guide member for guiding a distraction device to a location between layers of spinal tissue. The guide member has a proximal end portion and a distal end portion. The distal end portion is adapted for insertion between the tissue layers and defines a shape of a desired support structure. The distraction device is slidably mounted on the guide member for advancing the distraction device distally along the guide member for insertion of the distraction device between the tissue layers. The distraction device substantially conforms to the shape defined by the distal end portion of the guide member to form a support structure that separates, supports or both separates and supports the tissue layers.

Claims

1. An intravertebral implant system insertable into a human vertebral body having an interior region defined by a superior endplate, an inferior endplate and a cortical rim, the implant system comprising:

at least one elongated guide member having a proximal end portion and a distal end portion, said distal end portion changeable in configuration between a pre-deployed configuration and a deployed configuration, in the pre-deployed configuration said distal end portion being sized for insertion into the vertebral body, and in the deployed configuration said distal end portion defining a pre-determined shape that is sufficiently small to reside within the interior region of the vertebral body; and

an elongated intravertebral implant having opposed proximal and distal ends and a plurality of slots spaced apart along the intravertebral implant, the intravertebral implant including an opening at each end, a guide lumen extending between said end openings, the guide lumen slidably receiving the guide member therethrough so that the intravertebral implant may be longitudinally slidable on the guide member for advancing the intravertebral implant distally along the guide member for insertion into the vertebral body; and

when advanced along the distal end portion of the guide member said intravertebral implant substantially conforming to the pre-determined shape defined by the distal end portion of the guide member to form a vertically extending support structure that has a transverse dimension sufficiently small to reside within the interior region of the vertebral body, and a vertical extent sufficient to separate, support or both separate and support the superior and inferior endplates.

2. The implant system of claim 1 in which the pre-determined shape of the distal end portion of the guide member in the deployed configuration defines the shape of the desired support structure.

3. The implant system of claim 1 in which the pre-deployed configuration of the guide member is generally linear.

4. The implant system of claim 1 in which the distal end portion of the guide member self-forms into the deployed configuration.

5. The implant system of claim 4 in which at least the distal end portion of the guide member is comprised of a shape memory material.

6. The implant system of claim 1 in which the pre-determined shape formed by the distal end portion of the guide member in the deployed configuration is a coil-shape including a plurality of adjacent windings.

7. The implant system of claim 1 in which the pre-determined shape formed by the distal end portion of the guide member in the deployed configuration is a spiral or helical shape.

8. The implant system of claim 1 further including a cannula for assisting in the insertion of the distal end portion of the guide member into the vertebral body.

9. The implant system of claim 1 further including an energy source that produces ultrasonic vibrations operatively connected to the guide member to aid in the insertion of the distal end portion of the guide member to the location between tissue layers.

10. The implant system of claim 1 in which the guide member is adapted to be removed from the elongated intravertebral implant after the support structure is formed.

11. The implant system of claim 1 in which elongated intravertebral implant comprises an elongated member comprised of a polymeric material.

12. The implant system of claim 1 in which the vertebral body contains cancellous bone therewithin and the support structure includes a resident volume for containing cancellous bone.

13. The implant system of claim 1 in which the elongated intravertebral implant has a cross-sectional shape that assists in enhancing the flexibility of the elongated implant.

14. The implant system of claim 1 in which the elongated intravertebral implant includes at least one passageway for the introduction of a flowable material, said passageway configured to direct movement of the flowable material to desired locations.