Apparatus delivery in an intervertebral disc

• US 7,717,961 B2
• Filed: 02/05/2003
• Issued: 05/18/2010
• Est. Priority Date: 08/18/1999
• Status: Active Grant

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Einhorn, Jacob, Moore, Robert Kevin, Lambrecht, Gregory H.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): Cotroneo; Steven J
• Application Number:
  US10/359,516
• Publication Number:
  US 20050004578A1
• Time in Patent Office: 2,659 Days
• Field of Search: 606/99, 606/86.R, 606/86.A, 623 1711- 1716
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4514 Cartilage
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30723 Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30571 : Leaf springs
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• 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 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4661 : for measuring thickness
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• 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 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Abstract

The present invention relates generally to intervertebral disc devices and methods and instrumentation for intervertebral disc procedures. Methods include performing procedures such as implant delivery, tissue manipulation, tissue diagnostics, and therapeutic and diagnostic agent delivery at selected locations within intervertebral discs.

Claims

1. A method of delivering an implant within an intervertebral disc, comprising the steps of:

providing an insertion device having a hollow elongate body with a first stop surface thereon and an axially movable intradiscal element having a second stop surface thereon;

wherein said insertion device is coupled to an implant;

wherein said implant is configured to augment a defective portion of an anulus fibrosus;

advancing the device through an opening in the anulus fibrosus along a first axis;

bringing the second stop surface into contact with an interior aspect of the anulus fibrosus;

bringing the first stop surface into contact with an exterior surface of the anulus fibrosus;

determining the distance between the first stop surface and the second stop surface;

adjusting the distance between the first stop surface and the second stop surface so as to allow deployment between lamellae of the anulus fibrosus or within the nucleus pulposus;

wherein said adjustment limits penetration to a desired depth within the intervertebral disc;

deploying the implant laterally from the insertion device within the intervertebral disc along a second axis which is substantially transverse to the first axis; and

withdrawing the insertion device such that the deployed implant remains at the deployed location.

2. The method of claim 1, wherein the identifying step further comprises determining the location of the interface by interpreting tactile feedback.

3. The method of claim 1, wherein the identifying step further comprises determining the location of the interface by interpreting tactile feedback from surgical hand tools indicating change in compliancy of at least a portion of disc tissue.

4. The method of claim 1, wherein the implant is delivered from the distal end of the delivery tool at an offset angle.

5. The method of claim 1, wherein the implant is delivered along the innermost lamella of the anulus.

6. The method of claim 1, wherein the implant is delivered within the anulus.

7. The method of claim 1, wherein the implant is delivered to an area at least partially surrounding a defect within the anulus.

8. The method of claim 1, wherein the implant is delivered within the nucleus.

9. The method of claim 1, wherein the implant is delivered between the anulus and the nucleus.

10. The method of claim 1, wherein the implant is delivered between lamellae of the anulus.

11. The method of claim 1, wherein the second axis is roughly parallel to lamellae of the anulus fibrosus.

12. A method of delivering an intervertebral disc implant comprising:

identifying a first location corresponding to an inner surface of an anulus lamella of a selected intervertebral disc;

providing an implant delivery tool comprising an adjustable depth stop, a proximal end and a distal end;

wherein said delivery tool is coupled to an implant;

wherein said implant is configured to augment a defective portion of the anulus fibrosus;

inserting the delivery tool within the anulus such that said adjustable depth stop is placed against an external surface adjacent to the insertion site and the distal end of said delivery tool is inserted to a depth relative to said first location;

measuring a thickness of at least a portion of the anulus fibrosus adjacent the defective portion;

adjusting the position of the adjustable depth stop based on said measurement so as to permit deployment of the implant between lamellae of the anulus fibrosus or within the nucleus pulposus;

wherein said adjustment limits penetration to a desired depth within the intervertebral disc;

delivering the implant; and

withdrawing the delivery tool, leaving the delivered implant in place.

13. The method of claim 12, wherein the external surface is an outer surface of the anulus fibrosus of the functional spinal unit.

14. The method of claim 12, wherein the external surface is a portion of a superior vertebral body of the functional spinal unit.

15. The method of claim 12, wherein the external surface is a portion of an inferior vertebral body of the functional spinal unit.

16. The method of claim 12, wherein the implant is delivered along the innermost lamella of the anulus.

17. The method of claim 12, wherein the implant is delivered within the anulus.

18. The method of claim 12, wherein the implant is delivered to an area surrounding at least a portion of a defect within the anulus.

19. The method of claim 12, wherein the implant is delivered within the nucleus.

20. The method of claim 12, wherein the implant is delivered between the anulus and the nucleus.

21. The method of claim 12, wherein the implant is delivered between lamellae of the anulus.

22. The method of claim 12, wherein the external surface is a portion of a facet of the functional spinal unit.

23. The method of claim 12, wherein the external surface is a portion of a lamina of the functional spinal unit.

24. The method of claim 12, further comprising the step of determining a distance between the external surface adjacent to the insertion site and the depth relative to said first location.

25. The method of claim 24, further comprising the step of adjusting the distance between the depth stop and the distal end to correspond to the determined distance between the external surface adjacent to the insertion site and the depth relative to said first location.

26. The method of claim 12, wherein the identifying step further comprises determining said first location by interpreting tactile feedback.

27. The method of claim 12, wherein the identifying step further comprises determining said first location by interpreting tactile feedback from surgical hand tools indicating change in compliancy of at least a portion of disc tissue.

28. The method of claim 12, wherein the implant is delivered from the distal end of the delivery tool at an offset angle along a generally straight path.

29. The method of claim 12, further comprising inserting the at least portion of the delivery tool such that the at least portion of the delivery tool extends in a generally straight path roughly parallel to lamellae of the anulus fibrosus.

30. The method of claim 12, further comprising inserting the at least portion of the delivery tool such that the at least portion of the delivery tool is deflected by the delivery tool to extend laterally from a major longitudinal axis of the delivery tool.