Artificial disc spinal surgical prosthesis

• US 20040153156A1
• Filed: 01/21/2004
• Published: 08/05/2004
• Est. Priority Date: 07/26/1999
• Status: Active Grant

• Current Assignee: East Coast Medical & Dental Devices, Inc.
• Original Assignee: Advanced Prosthetic Technologies, Inc.
• Inventors: Cohen, Howard, Biro, Ladislau, Cohen, Matthew S.
• Granted Patent: US 7,282,063 B2
• Time in Patent Office: Days
• US Class Current: 623/17.13
• 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: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2/4455 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 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30237 partial tubes
• CPC Class Codes: A61F 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/3037 Translation along the common longitudinal axis, e.g. piston
• CPC Class Codes: A61F 2002/30372 with additional means for limiting said translation
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30392 Rotation
• CPC Class Codes: A61F 2002/304 : with additional means for limiting said sliding
• CPC Class Codes: A61F 2002/30411 : having two threaded end parts connected by a threaded central part with opposite threads at its opposite ends, i.e. for adjusting the distance between both end parts by rotating the central part
• CPC Class Codes: A61F 2002/30471 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30487 : Circumferential cooperating grooves and beads on cooperating lateral surfaces of a mainly longitudinal connection
• CPC Class Codes: A61F 2002/30494 : Cooperating protrusions and recesses, e.g. radial serrations, located on abutting end surfaces of a longitudinal connection
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30518 : with possibility of relative movement between the prosthetic parts
• CPC Class Codes: A61F 2002/30523 : by means of meshing gear teeth
• CPC Class Codes: A61F 2002/30538 : for adjusting angular orientation
• CPC Class Codes: A61F 2002/3054 : about a connection axis or implantation axis for selecting any one of a plurality of radial orientations between two modular parts, e.g. Morse taper connections, at discrete positions, angular positions or continuous positions
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• 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 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/3083 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30975 : made of two halves
• CPC Class Codes: A61F 2002/4485 : comprising three or more adjacent spinal implants
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• 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 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• 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

Abstract

A spinal surgical prosthesis such as an artificial disc having a pair of opposed plate members, a flexible support interposes therebetween and temporary stabilizer made of a bio-compatible and bio-resorbable material surrounding the flexible support between the opposed plate members. Prior to the resorption of the temporary stabilizer, the prosthesis serves as an inter-body fusion device for enhancing osteo-integration of the prosthesis with adjacent vertebrae during the healing phase following surgery. Subsequent to the resorption of the temporary stabilizer, the flexible support provides flexibility and compressibility while maintaining the proper inter disc space and lordosis or kyphosis between adjacent vertebrae.

Claims

1. An artificial disc for placement between adjacent vertebrae comprising:

at least two plate members, each plate member having a corresponding surface;

at least one means for temporarily stabilizing said plate members for a certain period of time to allow at least two of said plate members to osteo-integrate with adjacent vertebrae; and

at least one flexible supporting means interposed between said plate members and abutting said corresponding surfaces, said flexible support means flexibly supporting said plate members after said certain period of time.

2. The artificial disc as set forth in claim 1 comprising a pair of plate members, wherein said corresponding surface of each of said pair of plate members faces each other.

3. The artificial disc as set forth in claim 1 wherein said at lest one flexible supporting means is made of a bio-compatible and compressible material.

4. The artificial disc as set forth in claim 1 wherein said at least one flexible supporting means is made of titanium alloy.

5. The artificial disc as set forth in claim 1 wherein said at least one flexible supporting means comprises a flexible disc.

6. The artificial disc as set forth in claim 5 wherein said at least one flexible disc having opposed convex outer surfaces and each corresponding surface of each plate member correspondingly mates with each of said outer surface.

7. The artificial disc as set forth in claim 6 wherein each of said corresponding surfaces is concavely shaped.

8. The artificial disc as set forth in claim 1 wherein said at least one flexible supporting means comprises a bellows.

9. The artificial disc as set forth in claim 1 further comprising an elastomeric polymer between said plate members.

10. The artificial disc as set forth in claim 1 further comprising an elastomeric polymer within said flexible support means.

11. The artificial disc as set forth in claim 1 wherein said at least one temporarily stabilizing means is made of a substantially rigid bio-compatible and bio-resorbable material.

12. The artificial disc as set forth in claim 11 wherein said at least one temporarily stabilizing means comprises a rigid collar surrounding said flexible supporting means between said plate members such that upon resorption of said collar, said flexible supporting means remains between said plate members.

13. The artificial disc as set forth in claim 11 wherein said at least one temporarily stabilizing means comprises a supplemental support adapted to attach to at least two of said vertebrae such that upon resorption of said supplemental support, said flexible supporting means remains between said plate members.

14. The artificial disc as set forth in claim 13 wherein said supplemental support comprises photo-initiated polymer rod and screws.

15. The artificial disc as set forth in claim 13 wherein said supplemental support comprises photo-initiated polymer plate and screws.

16. The artificial disc as set forth in claim 8 wherein said at least one temporarily stabilizing means comprises a substantially rigid bio-resorbable material surrounding and adjacent said bellows between said plate members such that upon resorption of said material, said bellows remains between said plate members.

17. The artificial disc as set forth in claim 11 wherein said substantially rigid bio-compatible and bio-resorbable material is a polymer that is photocurable by ultra-violet light in the range of 350-385 nanometers in wavelength.

18. The artificial disc as set forth in claim 11 wherein said substantially rigid bio-compatible and bio-resorbable material is a polymer that is photocurable by visible light in the range of 385-550 nanometers in wavelength.

19. The artificial disc as set forth in claim 11 wherein said substantially rigid bio-compatible and bio-resorbable material is pliable and putty-like in an uncured state and not pliable in the cured state.

20. The artificial disc as set forth in claim 11 wherein said substantially rigid bio-compatible and bio-resorbable material is colored in an uncured state and turns clear in the cured state.

21. The artificial disc as set forth in claim 1 comprising two or more sets of plate members, at least one plate member from each set are interconnected and each set of plate members are independently and flexibly supported by each of said flexible supporting means.

22. The combination of an artificial disc and a substance comprising:

at least two plate members, each plate member having a corresponding surface;

at least one means for temporarily stabilizing said plate members for a certain period of time to allow at least two of said plate members to osteo-integrate with said adjacent vertebrae;

at least one flexible supporting means interposed between said plate members and abutting said corresponding surfaces, said flexible support means flexibly supporting said plate members after said certain period of time; and

a substance that promotes osseous integration and bone in-growth adjacent to said plate members.

23. The combination of an artificial disc and a substance comprising:

at least two plate members, each plate member having a corresponding surface;

at least one means for temporarily stabilizing said plate members for a certain period of time to allow at least two of said plate members to osteo-integrate with said adjacent vertebrae;

at least one flexible supporting means interposed between said plate members and abutting said corresponding surfaces, said flexible support means flexibly supporting said plate members after said certain period of time; and

a substance with hemostatic drug eluting factors to control bleeding adjacent to said plate members.

24. The combination of an artificial disc and a substance comprising:

at least two plate members, each plate member having a corresponding surface;

at least one means for temporarily stabilizing said plate members for a certain period of time to allow at least two of said plate members to osteo-integrate with said adjacent vertebrae;

at least one flexible supporting means interposed between said plate members and abutting said corresponding surfaces, said flexible support means flexibly supporting said plate members after said certain period of time; and

a substance with anti-microbial drug eluting factors to control and prevent infection adjacent to said plate members.

25. The combination of an artificial disc and a substance comprising:

at least two plate members, each plate member having a corresponding surface;

at least one means for temporarily stabilizing said plate members for a certain period of time to allow at least two of said plate members to osteo-integrate with said adjacent vertebrae;

at least one flexible supporting means interposed between said plate members and abutting said corresponding surfaces, said flexible support means flexibly supporting said plate members after said certain period of time; and

a substance with anti-tumor drugs to control or eradicate tumors adjacent to said plate members.

26. The combination of an artificial disc and a substance comprising:

at least two plate members, each plate member having a corresponding surface;

at least one means for temporarily stabilizing said plate members for a certain period of time to allow at least two of said plate members to osteo-integrate with said adjacent vertebrae;

at least one flexible supporting means interposed between said plate members and abutting said corresponding surfaces, said flexible support means flexibly supporting said plate members after said certain period of time; and

a substance with pain-controlling factors to control pain adjacent to said plate members.

27. A method of employing an artificial disc for achieving stability of adjacent vertebrae and preserving the inter-disc space comprising the steps of:

surgically exposing an area for placement of said artificial disc between adjacent vertebrae;

inserting said artificial disc having at least two plate members, with each plate member having a surface, in said space between adjacent vertebral end plates with at least two corresponding plate member abutting a corresponding vertebrae;

providing at least one means for temporarily stabilizing said plate members in said space for a certain period of time to allow at least two of said plate members to osteo-integrate with said adjacent vertebrae; and

providing at least one flexible supporting means interposed between and abutting said plate members, said flexible supporting means flexibly supporting said plate members after said certain period of time.

28. The method as in claim 27 wherein said at least one temporarily stabilizing means comprises a bio-compatible, bio-resorbable material.

29. The method as in claim 28 wherein said bio-compatible, bio-resorbable material is a polymer that is photocurable by ultra-violet light in the range of 350-385 nanometers in wavelength.

30. The method as in claim 28 wherein said bio-compatible, bio-resorbable material is a polymer that is photocurable by visible light in the range of 385-550 nanometers in wavelength.

31. The method as in claim 28 wherein said bio-resorbable material is pliable and putty-like in an uncured state and not pliable in the cured state.

32. The method as in claim 28 wherein said bio-resorbable material is colored in an uncured state and turns clear in the cured state.

33. The method as in claim 28 wherein said bio-resorbable material contains a substance that promotes osseous integration and bone in-growth.

34. The method as in claim 28 wherein said bio-resorbable material contains a substance with hemostatic drug eluting factors to control bleeding.

35. The method as in claim 28 wherein said bio-resorbable material contains a substance with anti-microbial drug eluting factors to control and prevent infection.

36. The method as in claim 28 wherein said bio-resorbable material contains a substance with anti-tumor drugs to control or eradicate tumors.

37. The method as in claim 28 wherein said bio-resorbable material contains a substance with pain-controlling factors to control pain.