Spinal disc prosthesis and methods of use

• US 7,799,080 B2
• Filed: 09/29/2006
• Issued: 09/21/2010
• Est. Priority Date: 04/22/2005
• Status: Expired due to Fees

• Current Assignee: Keith L. Doty
• Original Assignee: Keith L. Doty
• Inventors: Doty, Keith L.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): Yang; Andrew
• Application Number:
  US11/540,620
• Publication Number:
  US 20070021836A1
• Time in Patent Office: 1,453 Days
• Field of Search: 623 1711- 1716, 403/53, 403/57, 403/62
• US Class Current: 623/17.13
• CPC Class Codes: A61F 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• 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 2/4425 made of articulated components
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30492 using a locking pin
• CPC Class Codes: A61F 2002/30495 using a locking ring
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30566 Helical springs
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30639 having rolling elements between both articulating surfaces
• CPC Class Codes: A61F 2002/30649 Ball-and-socket joints
• CPC Class Codes: A61F 2002/30662 with rotation-limiting means
• CPC Class Codes: A61F 2002/30673 Lubricating means, e.g. synovial pocket
• CPC Class Codes: A61F 2002/30685 Means for reducing or preventing the generation of wear particulates
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/443 having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2310/00748 : Coating made of titanium carbide

Abstract

Spinal disc prosthetic devices are provided having up to six-degrees-of-freedom with three rotational and three translational degrees-of-freedom within the entire workspace of a Functional Spinal Unit (FSU). Certain embodiments of the prosthetic disc mechanisms attach to upper and lower plates anchored between vertebrae of an FSU allowing modularity of the devices. Scaling, conjoined mechanical programmability allow the devices to realize almost any nominal required spinal articulation, from the cervical to lumbar regions.

Claims

1. A prosthetic device for approximating spinal disc movement wherein said device can be implanted in the spine and engaged between a first and second vertebrae, such that when said device is implanted in the spine and engaged with a first and second vertebra, said device forms an interlocking kinematic chain between said first and second vertebra, wherein said kinematic chain comprises:

an axial spring;

a lateral sleeve attached to one end of said axial spring;

a lateral rod disposed within said lateral sleeve;

a lateral cylindrical joint platform in which said lateral sleeve is movably engaged and said lateral rod is positioned, such that said lateral sleeve can slide along the lateral rod and rotate about the lateral rod within the lateral cylindrical joint platform;

a sagittal sleeve attached to the opposite end of the axial spring;

a sagittal rod disposed within said sagittal sleeve; and

a sagittal cylindrical joint platform in which said sagittal sleeve is movably engaged and said sagittal rod is fixedly positioned, such that said sagittal sleeve can slide along the sagittal rod and rotate about the sagittal rod within the sagittal cylindrical joint platform;

such that there is provided up to three independent rotational degrees of freedom and up to three independent linear degrees of freedom.

2. The device, according to claim 1, wherein the axial spring is capable of simultaneous movement in the lateral, sagittal, and axial linear directions.

3. The device, according to claim 2, wherein the at east three linear directions are lateral, sagittal and axial.

4. The device, according to claim 1, wherein the axial spring comprises sufficient tension to permit continuous self-alignment with the axis of a functional spinal unit during flexion or extension motions.

5. The device, according to claim 1, further comprising vertebral plates, for engagement with a first and second vertebrae removably attached to the cylindrical joint platforms.

6. The device, according to claim 5, wherein said vertebral plates comprise a material selected from the group consisting of titanium, cobalt-chromium-molybdenum alloy, and titanium-carbide-coated stainless steel with a bone fusion matrix.

7. The device, according to claim 1, further comprising a boot removably connected with each of said cylindrical joint platforms, such that elements of the kinematic chain are sealed within the boot thereby preventing fluids within the device from contacting fluids external to said device.

8. The device, according to claim 7, wherein said boot comprises a strong, flexible, non-homogeneous, fiber reinforced elastomer matrix.

9. The device, according to claim 8, wherein the reinforcing fibers are located external to the elastomer matrix.

10. The device, according to claim 8, wherein said boot is capable of providing torsional load bearing.

11. The device, according to claim 8, wherein said boot is capable of providing non-linear compression and extension.

12. The device, according to claim 7, wherein said boot comprises at least one edge having a shape that removably engages with at least one channel of compatible shape and wherein said channel is positioned around the circumference of a cylindrical joint platform.

13. The device, according to claim 7, further comprising a biocompatible lubricant sealed within the boot.

14. The device, according to claim 7, further comprising one or more pass through holes that allow said biocompatible lubricant to be circulated around and through the moveable elements of the device.

15. The device, according to claim 1, wherein said lateral and sagittal cylindrical joint platforms further comprise at least one removable endplate to permit positioning of the rods and sleeves within the cylindrical joint platforms.

17. The device according to claim 1, wherein the length of the device, from the end of the lateral cylindrical joint platform to the end of the sagittal cylindrical joint platform is approximately 14.0 mm.

18. The device, according to claim 1, wherein the axial spring is capable of movement in at least one linear direction.

19. The device, according to claim 1, wherein the axial spring is capable of simultaneous torsion and extension and/or compression.

20. The device, according to claim 1, wherein one or more elements of said kinematic chain comprise a material selected from the group consisting of titanium steel, titanium-carbide-coated stainless steel, polyurethane, thermoplastics, cobalt-chromium-molybdenum alloy.

21. The device, according to claim 1, wherein the axial spring is capable of movement in at least one linear direction.

22. The device, according to claim 1, wherein the axial spring is capable of simultaneous movement in at least three linear directions.

23. The device, according to claim 22, wherein the at least three linear directions are lateral, sagittal and axial.

16. A prosthetic device for approximating spinal disc movement wherein said device can be implanted in the spine and engaged between a first and second vertebrae, such that when said device is implanted in the spine and engaged between a first and second vertebra, said device forms an interlocking kinematic chain between said first and second vertebra, wherein said interlocking kinematic chain comprises:

an axial spring;

a lateral sleeve, having at least one aperture therein, fixedly attached to one end of said axial spring;

a lateral spring, disposed within said lateral sleeve, having at least one tang fixedly attached thereon and positioned within the at least one aperture of said lateral sleeve;

a lateral cylindrical joint platform in which said lateral sleeve is movably engaged and the ends of said lateral spring are fixedly positioned, such that said lateral sleeve can slide along the lateral spring and can rotate about said lateral spring whereby said at least one tang can contact one or more sides of the at least one aperture causing torquing of the lateral spring;

a sagittal sleeve, having at least one aperture therein, fixedly attached to the opposite end of the axial spring;

a sagittal spring, disposed within said sagittal sleeve, having at least one tang fixedly attached thereon and positioned within the at least one aperture of said lateral sleeve; and

a sagittal cylindrical joint platform in which said sagittal sleeve is movably engaged and the ends of said sagittal spring are fixedly positioned, such that said sagittal sleeve can slide along the sagittal spring and can rotate about said sagittal spring whereby said at least one tang can contact one or more sides of the at least one aperture causing torquing of the sagittal spring;

such that there is provided up to three independent rotational degrees of freedom and up to three independent linear degrees of freedom.

24. The device, according to claim 16, wherein the axial, sagittal, and lateral springs are capable of simultaneous torsion and extension and/or compression.

25. The device, according to claim 24, thither comprising a boot with a biocompatible, colloidal, elastomeric suspension sealed therein, said boot being removably connected with each of said cylindrical joint platforms, such that elements of the kinematic chain are sealed within the boot thereby preventing the suspension within the boot from contacting fluids external to said device.

26. The device, according to claim 25, further comprising one or more pass through holes that allow said biocompatible lubricant to be circulated around and through the moveable elements of the device.

27. The device, according to claim 25, wherein said boot comprises a strong, flexible, non-homogeneous, fiber reinforced elastomer matrix.

28. The device, according to claim 27, wherein the reinforcing fibers are located external to the elastomer matrix.

29. The device, according to claim 25, wherein said boot comprises at least one edge having a shape that removably engages with at least one channel of compatible shape and positioned around the circumference of the interior of a cylindrical joint platform.

30. The device, according to claim 25, wherein said boot is capable of providing torsional load bearing.

31. The device, according to claim 25, wherein said boot is capable of providing non-linear compression and extension.

32. The device, according to claim 25, further comprising a biocompatible lubricant sealed within the boot.

33. The device, according to claim 24, wherein said lateral and sagittal cylindrical joint platforms further comprise at least one removable endplate to permit positioning of the rods and sleeves within the cylindrical joint platforms.

34. The device, according to claim 24, wherein one or more elements of said kinematic chain comprise a material selected from the group consisting of titanium steel, titanium-carbide-coated stainless steel, polyurethane, thermoplastics, cobalt-chromium-molybdenum alloy, and plastic.

35. The device, according to claim 24, wherein the lateral, and sagittal springs comprise sufficient tension to resist longitudinal bending and permit continuous self-alignment along their central axis.

36. The device, according to claim 24, wherein the axial spring comprises sufficient tension to permit continuous self-alignment with the axis of a functional spinal unit after flexion or extension motions.

37. The device, according to claim 24, further comprising vertebral plates, for engagement with a first and second vertebrae, removably attached to the cylindrical joint platforms.

38. The device, according to claim 37, wherein said vertebral plates comprise a material selected from the group consisting of titanium, cobalt-chromium-molybdenum alloy, and titanium-carbide-coated stainless steel with a bone fusion matrix.

39. A prosthetic device for approximating spinal disc movement wherein said device can be implanted in the spine between a first and second vertebrae, such that when said device is implanted in the spine and engaged with a first and second vertebra, said device forms an interlocking kinematic chain between said first and second vertebra, wherein said interlocking kinematic chain comprises:

an axial spring;

a lateral rocker-slider fixedly attached to one end of said axial spring, wherein the lateral rocker-slider comprises a first joint shaft slidably disposed within a first sleeve;

a lateral cylindrical joint platform in which said lateral rocker-slider is movably attached within a lateral joint axis such that the lateral rocker-slider sleeve can slide along the lateral joint axis and rotate or rock about the lateral joint axis;

a sagittal rocker-slider fixedly attached to the opposite end of the axial spring, wherein the sagittal rocker slider comprises a second joint shaft slidably disposed within a second sleeve;

a sagittal cylindrical joint platform in which said sagittal rocker-slider is movably attached within a sagittal joint axis such that the sagittal rocker-slider sleeve can slide along the sagittal joint axis and rotate or rock about the sagittal joint axis;

such that there is provided up to three independent rotational degrees of freedom and up to three independent linear degrees of freedom.

40. The device, according to claim 39, wherein a joint shaft comprises one or more springs positioned along the lateral and/or sagittal joint axes to oppose and/or dampen the motion of the lateral and/or sagittal rocker slider.

41. The device, according to claim 39, further comprising vertebral plates, for engagement with a first and second vertebrae, removably attached to the cylindrical joint platforms.

42. The device, according to claim 41, wherein said vertebral plates comprise a material selected from the group consisting of titanium, cobalt-chromium-molybdenum alloy, and titanium-carbide-coated stainless steel with a bone fusion matrix.

43. The device, according to claim 41, further comprising a circumferential shape selected from the group consisting of squared, rectangular, circular, and ovoid.

44. The device, according to claim 43, wherein said circumferential shape is circular.

45. The device, according to claim 39, further comprising a boot removably connected with each of said cylindrical joint platforms, such that elements of the kinematic chain are sealed within the boot thereby preventing fluids within the device from contacting fluids external to said device.

46. The device, according to claim 45, wherein said boot comprises a strong, flexible, non-homogeneous, fiber reinforced elastomer matrix.

47. The device, according to claim 46, wherein the reinforcing fibers are located external to the elastomer matrix.

48. The device, according to claim 45, wherein said boot comprises at least one edge having a shape that removably engages with at least one channel of compatible shape and positioned around the circumference of the interior of a cylindrical joint platform.

49. The device, according to claim 45, wherein said boot is capable of providing torsional load bearing.

50. The device, according to claim 45, wherein said boot is capable of providing non-linear compression and extension.

51. The device, according to claim 45, further comprising a biocompatible lubricant sealed within the boot.

52. The device, according to claim 39, further comprising a boot with a biocompatible colloidal elastomeric suspension sealed therein.

53. The device, according to claim 52, further comprising one or more pass through holes that allow said biocompatible suspension to be circulated around and through the moveable elements of the device.

54. The device, according to claim 39, wherein said lateral and sagittal cylindrical joint platforms further comprise at least one removable end brace to permit positioning of rocker-sliders within the cylindrical joint platforms.

55. The device, according to claim 41, further comprising opposable threads on the vertebral plates that are compatible with opposable threads on the cylindrical joint platforms such that the device can be positioned between the vertebral plates and twisted or turned in one direction to secure the device simultaneously between two vertebral plates.

56. The device, according to claim 39, wherein the axial spring is capable of movement in at least one linear direction.

57. The device, according to claim 39, wherein the axial spring is capable of simultaneous movement in at least three linear directions.

58. The device, according to claim 57, wherein the at least three linear directions are lateral, sagittal and axial.

59. The device, according to claim 39, wherein the lateral and sagittal rocker-slider elements comprise springs having sufficient tension to resist longitudinal bending and permit continuous self-alignment along their central axis.

60. The device, according to claim 39, wherein the axial spring comprises sufficient tension to permit continuous self-alignment with the axis of a functional spinal unit after flexion or extension motions.

61. The device, according to claim 39, wherein the axial spring is capable of simultaneous torsion and extension and/or compression.

62. The device, according to claim 39, wherein one or more elements of said kinematic chain comprise a material selected from the group consisting of titanium steel, titanium-carbide-coated stainless steel, polyurethane, thermoplastics, cobalt-chromium-molybdenum alloy, and plastics.

63. The device, according to claim 39, wherein a joint shaft comprises a rod.

64. A method for approximating spinal disc movement utilizing a device comprising:

an axial spring;

a lateral rocker-slider fixedly attached to one end of said axial spring, wherein the lateral rocker-slider comprises a first joint shaft slidably disposed within a first sleeve;

a lateral cylindrical joint platform in which said lateral rocker-slider is movably attached within a lateral joint axis such that the lateral rocker-slider sleeve can slide along the lateral joint axis and rotate or rock about the lateral joint axis;

a sagittal rocker-slider fixedly attached to the opposite end of the axial spring, wherein he sagittal rocker-slider comprises a second joint shaft slidably disposed within a first sleeve;

a sagittal cylindrical joint platform in which said sagittal rocker-slider is movably attached within a sagittal joint axis such that the sagittal rocker-slider sleeve can slide along the sagittal joint axis and rotate or rock about the sagittal joint axis;

said method comprising implanting the device between a first and second vertebrae, such that with said device engaged between the first and second vertebrae, there is formed a kinematic chain between the first and second vertebrae, such that there is provided at least one and up to three independent rotational degrees of freedom and at least one and up to three independent linear degrees of freedom.