Devices and method for augmenting a vertebral disc

• US 20040097924A1
• Filed: 05/07/2003
• Published: 05/20/2004
• Est. Priority Date: 08/18/1999
• Status: Active Grant

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Einhorn, Jacob, Lambrecht, Gregory, Kavanaugh, Sean, Partin, Jason
• Granted Patent: US 7,507,243 B2
• Time in Patent Office: Days
• US Class Current: 606/60
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• 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 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• 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

A vertebral disc prosthesis, a method of implanting a prosthesis and a deployment device is provided. The prosthesis may be implanted into the interior region of the vertebral disc so as to displace existing vertebral tissue, such as NP. The size or amount of the prosthesis inserted into the interior region of the vertebral disc may be a characteristic of the disc or the prosthesis. For example, the amount or size of prosthesis inserted into the disc may be dependent upon restoring the functionality of the disc (e.g., the ability of the disc to transfer nutrients or otherwise survive, the ability of the disc to carry the required loads and absorb stress or the reduction of pain). Restoring disc function may be determined by the resulting disc height desired, the resulting disc pressure desired or the resulting disc volume desired. The prosthesis may be sized or positioned within the interior of the vertebral disc such that it is spaced from at least one of the end plates of the vertebral disc. The prosthesis may be formed of a material having a compression strength that is less than 4 mn/m². A deployment device may be used to facilitate placement of the prosthesis within the vertebral disc. The prosthesis may include a grouping of multiple components that can be deployed as group.

Claims

1. A device for delivering a prosthesis material to an interior region of a vertebral disc, the device comprising:

a body having a proximal end and a distal end;

a holder region disposed adjacent the distal end of the body, the holder region being adapted to hold the prosthesis material prior to delivery into the interior region of the vertebral disc;

a plunger disposed within the body, the plunger and body adapted to move relative to each other to dispense the prosthesis material; and

a stop disposed on the body, the stop being adapted to allow positioning of the body relative to the interior region of the vertebral body such that the prosthesis material can be dispensed within the interior region of the vertebral body at a desired location.

2. The device according to claim 1, wherein the stop is adjustable relative to at least the body.

3. The device according to claim 1, wherein the plunger comprises a first end defining a first handle adapted to be manipulated by a user, and a second end adapted to dislodge the prosthesis material from the holder region upon actuation of the first handle.

4. The device according to claim 3, wherein the body comprises an elongate hollow sleeve and wherein the plunger is axially slidable within the sleeve.

5. The device according to claim 4, wherein the sleeve defines a second handle, the second handle adapted to be grasped by a user such that the user can displace the first handle relative to the second handle.

6. The device according to claim 4, wherein the holder region is defined by the distal end of the elongate hollow sleeve.

7. The device according to claim 1, in combination with the prosthesis material.

8. The combination according to claim 7, wherein the device is pre-loaded with the prosthesis material.

9. The device according to claim 1, wherein the body comprises a hollow sleeve that is adapted to be retracted relative to the plunger to dispense the prosthesis material upon retraction of the sleeve.

10. The device according to claim 1, wherein the distal end is flexible.

11. The device according to claim 1, wherein the body defines a longitudinal axis and wherein the distal end is adapted to articulate relative to the axis.

12. The device according to claim 1, wherein the holder region is adapted to hold the prosthesis material within the body, wherein the holder region comprises a plurality of openings, each opening adapted to allow prosthesis material to be dispensed from within the holder region.

13. The device according to claim 1, further comprising a gauge cooperating with the device, the gauge adapted to measure the insertion force of the prosthesis material entering into the inner region of the vertebral disc.

63. A kit of parts for use in augmenting vertebral tissue, the kit comprising:

a prosthesis adapted for insertion into the vertebral disc; and

the delivery device according to any of claims 1, 14, 26, 34 and 46.

14. A device for delivering a prosthesis material to an interior region of a vertebral disc, the device comprising:

a body having a proximal end and a flexible distal end, the body defining a longitudinal axis, the flexible distal end being adapted to articulate relative to the axis;

a holder region disposed adjacent the distal end of the body, the holder region being adapted to hold the prosthesis material prior to delivery into the interior region of the vertebral disc; and

a plunger disposed within the body, the plunger and body adapted to move relative to each other to dispense the prosthesis.

15. The device according to claim 14, further comprising an adjustable stop disposed on the body.

16. The device according to claim 14, wherein the plunger comprises a first handle adapted to be manipulated by a user, and a second end adapted to dislodge the prosthesis material from the holder region upon actuation of the first handle.

17. The device according to claim 16, wherein the body comprises an elongate hollow sleeve and wherein the plunger is axially slidable within the sleeve.

18. The device according to claim 17, wherein the sleeve defines a second handle, the second handle adapted to be grasped by a user such that the user can displace the first handle relative to the second handle.

19. The device according to claim 17, wherein the holder region is defined by the distal end of the elongate hollow sleeve.

20. The device according to claim 14, in combination with the prosthesis material.

21. The combination according to claim 20, wherein the device is pre-loaded with the prosthesis material.

22. The device according to claim 14, further comprising an actuator adapted to articulate the flexible distal end.

23. The device according to claim 14, wherein the body comprises a hollow sleeve that is adapted to be retracted relative to the plunger to dispense the prosthesis material upon retraction of the sleeve.

24. The device according to claim 14, wherein the holder region is adapted to hold the prosthesis material within the body, wherein the holder region comprises a plurality of openings, each opening adapted to allow prosthesis material to be dispensed from within the holder region.

25. The device according to claim 14, further comprising a gauge cooperating with the device, the gauge adapted to measure the insertion force of the prosthesis material into the inner region of the vertebral disc.

26. A device for delivering a prosthesis material to an interior region of a vertebral disc, the device comprising:

a body having a proximal end and a distal end, the body being formed as a hollow sleeve;

a holder region disposed adjacent the distal end of the body, the holder region being adapted to hold the prosthesis material prior to delivery into the interior region of the vertebral disc; and

a plunger axially disposed within the sleeve, the sleeve adapted to be retracted relative to the plunger to dislodge the prosthesis material from the holder region upon retraction of the sleeve.

27. The device according to claim 26, further comprising an adjustable stop disposed on the body.

28. The device according to claim 26, wherein the plunger comprises a first handle and the sleeve comprising a second handle, the handles adapted to be grasped by a user such that the user can displace the handles relative to each other.

29. The device according to claim 26, wherein the holder region is defined by the distal end of the elongate hollow sleeve.

30. The device according to claim 26, in combination with the prosthesis material.

31. The combination according to claim 30, wherein the device is pre-loaded with the prosthesis material.

32. The device according to claim 26, wherein the holder region is adapted to hold the prosthesis material within the body, wherein the holder region comprises a plurality of openings, each opening adapted to allow prosthesis material to be dispensed from within the holder region.

33. The device according to claim 26, further comprising a gauge cooperating with the device, the gauge adapted to measure the insertion force of the prosthesis material into the inner region of the vertebral disc.

34. A device for delivering a prosthesis material to an interior region of a vertebral disc, the device comprising:

a body having a proximal end and a distal end;

a holder region disposed adjacent the distal end, the holder region being adapted to hold the prosthesis material prior to delivery into the interior region of the vertebral disc, the holder region comprising a plurality of openings, each opening adapted to allow prosthesis material to be dispensed from within the holder region; and

a plunger disposed within the body, the plunger and body adapted to move relative to each other to dispense the prosthesis material.

35. The device according to claim 34, further comprising an adjustable stop disposed on the body.

36. The device according to claim 34, wherein the plunger comprises a first handle adapted to be manipulated by a user, and a second end adapted to dislodge the prosthesis material from the holder region upon actuation of the first handle.

37. The device according to claim 36, wherein the body comprises an elongate hollow sleeve and wherein the plunger is axially slidable within the sleeve.

38. The device according to claim 37, wherein the sleeve defines a second handle, the second handle adapted to be grasped by a user such that the user can displace the first handle relative to the second handle.

39. The device according to claim 37, wherein the holder region is defined by the distal end of the elongate sleeve.

40. The device according to claim 34, in combination with the prosthesis material.

41. The combination according to claim 40, wherein the device is pre-loaded with the prosthesis material.

42. The device according to claim 34, wherein the body comprises a hollow sleeve that is adapted to be retracted relative to the plunger to dispense the prosthesis material upon retraction of the sleeve.

43. The device according to claim 34, wherein the distal end is flexible.

44. The device according to claim 34, wherein the body defines a longitudinal axis and wherein the distal end is adapted to articulate relative to the axis.

45. The device according to claim 34, further comprising a gauge cooperating with the device, the gauge adapted to measure the insertion force of the prosthesis material into the inner region of the vertebral disc.

46. A device for delivering a prosthesis material to an interior region of a vertebral disc, the device comprising:

a body having a proximal end and a distal end;

a holder region disposed adjacent the distal end of the body, the holder region being adapted to hold the prosthesis material prior to delivery into the interior region of the vertebral disc;

a plunger disposed within the body, the plunger and body adapted to move relative to each other to dispense the prosthesis material; and

a gauge cooperating with the device, the gauge adapted to measure the insertion force of the prosthesis material into the inner region of the vertebral disc.

47. The device according to claim 46, further comprising an adjustable stop disposed on the body.

48. The device according to claim 46, wherein the plunger comprises a first end defining a first handle adapted to be manipulated by a user, and a second end adapted to dislodge the prosthesis material from the holder upon actuation of the first handle.

49. The device according to claim 48, wherein the body comprises an elongate hollow sleeve and wherein the plunger is axially slidable within the sleeve.

50. The device according to claim 49, wherein the sleeve defines a second handle, the second handle adapted to be grasped by a user such that the user can displace the first handle relative to the second handle.

51. The device according to claim 49, wherein the holder region is defined by the distal end of the elongate hollow sleeve.

52. The device according to claim 46, in combination with the prosthesis material.

53. The combination according to claim 52, wherein the device is pre-loaded with the prosthesis material.

54. The device according to claim 46, wherein the body comprises a hollow sleeve that is adapted to be retracted relative to the plunger to dislodge the prosthesis material upon retraction of the sleeve.

55. The device according to claim 46, wherein the distal end is flexible.

56. The device according to claim 46, wherein the body defines a longitudinal axis and wherein the distal end is adapted to articulate relative to the axis.

57. The device according to claim 46, wherein the holder region is adapted to hold the prosthesis material within the body, wherein the holder region comprises a plurality of openings, each opening adapted to allow prosthesis material to be dispensed from within the holder region.

58. A method for delivering a prosthesis material into an interior region of a vertebral disc, the method comprising:

providing a delivery device having a body having a proximal end and a distal end and a holder region disposed adjacent the distal end, the holder region adapted to hold the prosthesis material prior to delivery into the interior region of the vertebral disc, the delivery device further comprising a plunger cooperating with the body;

loading the holder region with the prosthesis material;

advancing at least a portion of the device to a desired location within the vertebral disc; and

moving the plunger relative to the body to dislodge the prosthesis material from the device.

59. The method according to claim 58, further comprising engaging a portion of the body against an outer surface of the vertebral disc and inserting at least a portion of the distal end into the interior region of the vertebral disc.

60. The method according to claim 58, further comprising measuring the insertion force of the prosthesis material entering into the inner region of the vertebral disc.

61. The method according to claim 58, wherein loading the holder region with the prosthesis material comprises packaging the device with the prosthesis material pre-loaded in the holder region.

62. The method according to claim 58, further comprising measuring the pressure within the inner region of the vertebral disc.