Human spinal disc prosthesis

• US 5,674,296 A
• Filed: 07/22/1996
• Issued: 10/07/1997
• Est. Priority Date: 11/14/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Sofamor Danek Incorporated (Medtronic Plc)
• Original Assignee: Spinal Dynamics Corporation (Medtronic Plc)
• Inventors: Bryan, Vincent, Kunzler, Alex
• Primary Examiner(s): JONES, MARYBETH O
• Application Number:
  US08/681,230
• Time in Patent Office: 442 Days
• Field of Search: 623/16-17, 623/18, 606/61, 606/72, 606/73
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• 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 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/4425 made of articulated components
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30168 L-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30214 having tapered sections of different conicities
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30253 ellipsoidal or ovoid
• 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 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30461 : sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30469 : using band clamps
• CPC Class Codes: A61F 2002/30474 : using an intermediate sleeve interposed between both prosthetic parts to be coupled
• CPC Class Codes: A61F 2002/30487 : Circumferential cooperating grooves and beads on cooperating lateral surfaces of a mainly longitudinal connection
• 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 2002/30576 : with extending fixation tabs
• CPC Class Codes: A61F 2002/30578 : having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• 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 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30624 : Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30663 : multiaxial, e.g. biaxial; multipolar, e.g. bipolar or having an intermediate shell articulating between the ball and the socket
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• 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 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• 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 2230/0006 : circular
• CPC Class Codes: A61F 2230/0043 : L-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• 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: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

The invention relates to a spinal disc endoprosthesis. The endoprosthesis has a resilient body formed of one or more materials which may vary in stiffness from a relatively stiff exterior annular gasket portion to a relatively supple central nucleus portion. Concaval-convex elements at least partly surround that nucleus portion so as to retain the nucleus portion and gasket between adjacent vertebral bodies in a patient'"'"'s spine. Assemblies of endoprosthetic discs, endoprosthetic vertebral bodies, and endoprosthetic longitudinal ligaments may be constructed. To implant this endoprosthesis assembly, information is obtained regarding the size, shape, and nature of a patient'"'"'s damaged spine. Thereafter, one or more prosthetic vertebral bodies and disc units are constructed in conformity with that information. Finally, the completed and conformed vertebral body and disc assembly is implanted in the patient'"'"'s spine.

Claims

1. A vertebral disc endoprosthesis, comprising a resilient body formed of materials varying in stiffness from a relatively stiff exterior portion to a relatively supple central portion;

and concaval-convex elements at least partly surrounding the resilient body between adjacent vertebral bodies for retaining the resilient body between adjacent vertebral bodies in a patient'"'"'s spine, and wherein said concaval-convex elements each comprise generally L-shaped supports, each support having a first concaval-convex leg, the first leg having an outer convex surface for engaging adjacent bone and a corresponding inner concave surface for retaining the resilient body, each support further having a second leg extending generally perpendicularly to the first leg and adapted for affixation to adjacent bone structure.

2. A vertebral disc endoprosthesis according to claim 1 wherein said resilient body comprises an annular gasket and a nuclear central portion.

3. A vertebral disc endoprosthesis according to claim 1 further comprising cannulated screw means for attaching the concaval-convex element supports to adjacent bone structure.

4. A vertebral disc endoprosthesis according to claim 3 wherein said cannulated screw means comprises a screw, and a screw anchor seatable within bone structure and adapted to threadably receive the screw.

5. A vertebral disc endoprosthesis according to claim 1 further comprising a seal member attached to the concaval-convex elements and surrounding said resilient body.

6. A vertebral disc endoprosthesis according to claim 5 wherein said seal member comprises a flexible shell material having a multiplicity of pores, the pores being from about 5 microns to about 60 microns in size.

7. A vertebral disc endoprosthesis according to claim 6 further including sealing means applied to said flexible sheet material to render said flexible sheet material substantially impervious to the passage of any fluid.

8. A vertebral disc endoprosthesis according to claim 5 wherein said concaval-convex elements and said seal member collectively surround said resilient body with a watertight seal.

9. A vertebral disc endoprosthesis according to claim 2 wherein said annular gasket is relatively stiff and said nuclear central portion is relatively supple.

10. A vertebral disc endoprosthesis according to claim 1 wherein said concaval-convex elements are formed of a biocompatible metal.

11. A vertebral disc endoprosthesis according to claim 1 wherein said concaval-convex elements are formed of a metal containing titanium.

12. A vertebral disc endoprosthesis according to claim 1 wherein said concaval-convex elements are formed of a metal containing chromium cobalt.

13. A vertebral disc endoprosthesis according to claim 10 wherein said concaval-convex elements are each partly defined by exterior surfaces, and wherein the endoprosthesis further includes metal beading on at least part of the exterior concaval-convex element surfaces for encouraging bonding between bone and said exterior concaval-convex element surfaces.

14. A vertebral disc endoprosthesis according to claim 1 wherein said concaval-convex elements are provided with roughened outer surfaces to encourage positive bonding of bone to said concaval-convex element surfaces.

15. A vertebral disc endoprosthesis according to claim 1 wherein said concaval-convex elements are formed of a non-oncogenic material.

16. The vertebral disc endoprosthesis according to claim 1 wherein each concaval-convex element is provided with a respective groove.

17. The vertebral disc endoprosthesis according to claim 16 further comprising a seal member including beaded edges, the seal member attached to the concaval-convex elements and surrounding said resilient body.

18. The vertebral disc endoprosthesis according to claim 17 further comprising retainer means for retaining the seal member against said grooves, the retainer means cooperating with the beaded edges and the grooves to form a watertight seal.

19. The vertebral disc endoprosthesis according to claim 18 wherein the retainer means can be in one of the following forms:

a biocompatible monofilament metal wire, a synthetic polymer band or a braided wire cable.

20. The vertebral disc endoprosthesis according to claim 19 wherein the biocompatible monofilament metal wire is formed of stainless steel or titanium.

21. The vertebral disc endoprosthesis according to claim 18 further comprising a crimping means for crimping the retainer means about the seal member.

22. The vertebral disc endoprosthesis according to claim 1 wherein each support includes a groove about its circumference, the groove encircling the periphery of the first leg.

23. A vertebral endoprosthesis comprising an integral disc unit, said unit including a pair of confronting L-shaped supports having concaval-convex shapes in given legs, a resilient body interposed between the supports, and a flexible seal extending from one support to the other and sealing the resilient body within the supports inside a substantially watertight compartment.

24. A vertebral endoprosthesis according to claim 23 further comprising a plurality of said integral disc units.

25. The vertebral endoprosthesis according to claim 23 wherein each support includes a groove about its periphery and wherein the seal includes beaded edges.

26. The vertebral endoprosthesis according to claim 25 further comprising retainer means for retaining the seal against said grooves, the retainer means cooperating with the beaded edges and the grooves to form a watertight seal.

27. The vertebral endoprosthesis according to claim 26 wherein the retainer means can be in one of the following forms:

a biocompatible monofilament metal wire, a synthetic polymer band or a braided wire cable.

28. The vertebral endoprosthesis according to claim 27 wherein the biocompatible monofilament metal wire is formed of stainless steel or titanium.

29. The vertebral endoprosthesis according to claim 26 further comprising a crimping means for crimping the retainer means about the seal.

30. A vertebral disc endoprosthesis comprising a resilient nucleus, rigid concaval-convex elements at least partly surrounding the nucleus, an annular gasket ring surrounding the nucleus, and a seal member formed of flexible material and attached to the concaval-convex elements and surrounding the nucleus and the annular gasket ring.

31. A vertebral disc endoprosthesis according to claim 30 wherein said concaval-convex elements each comprise generally L-shaped supports, each support having a first concaval-convex leg, the first leg having an outer convex surface for engaging adjacent bone and a corresponding inner concave surface for retaining the nucleus, each support further having a second leg extending generally perpendicularly to the first leg and adapted for affixation to adjacent bone structure.

32. A vertebral disc endoprosthesis, according to claim 31 further including screw means adapted for connection to said legs and for affixation in a generally radial direction in adjacent generally cylindrical bone vertebrae.

33. The vertebral disc endoprosthesis according to claim 31 wherein each support includes a groove about its circumference.

34. A vertebral disc endoprosthesis according to claim 30 further including means affixed to the concaval-convex elements for encouraging bone growth partially upon and bone bonding with said concaval-convex elements.

35. A vertebral disc endoprosthesis according to claim 30 further including means for interconnecting one of said concaval-convex elements to a concaval-convex element of another vertebral disc endoprosthesis, thereby permitting the replacement of several natural vertebral discs.

36. The vertebral disc endoprosthesis according to claim 30 wherein each element includes a respective groove and wherein the seal member includes beaded edges.

37. The vertebral disc endoprosthesis according to claim 36 further comprising retainer means for retaining the seal member against said grooves, the retainer means cooperating with the beaded edges and the grooves to form a watertight seal.

38. The vertebral disc endoprosthesis according to claim 37 wherein the retainer means can be in one of the following forms:

a biocompatible monofilament metal wire, a synthetic polymer band or a braided wire cable.

39. The vertebral disc endoprosthesis according to claim 38 wherein the biocompatible monofilament metal wire is formed of stainless steel or titanium.

40. The vertebral disc endoprosthesis according to claim 37 further comprising a crimping means for crimping the retainer means about the seal member.

41. A vertebral disc endoprosthesis comprising a resilient nucleus, first and second rigid concaval-convex elements at least partly surrounding the nucleus, first and second legs formed, respectively, with the first and second rigid concaval-convex elements, first and second means for affixing the respective legs to vertebral bodies adjacent the concaval-convex elements and nucleus, and longitudinal ligament prosthesis means extending between the legs of the first and second concaval-convex elements to inhibit undesirable motion of the vertebral bodies relative to one another.

42. A vertebral disc endoprosthesis comprising a rounded, resilient nucleus body convex on all surfaces and concaval-convex elements, each concaval-convex element being of relatively constant cross-sectional thickness and having an outer convex surface for engaging adjacent bone structure which has been milled to mate with the concaval-convex element outer convex surface, and a corresponding inner concave surface for engaging the rounded resilient body, wherein said resilient nucleus body comprises a relatively resilient central body and a relatively stiff gasket surrounding a circumference of the central body, the resilient nucleus body snugly engaging the adjacent, mating concave surfaces of the concaval-convex elements.

43. A vertebral disc endoprosthesis according to claim 42 wherein the concaval-convex elements do not engage one another.