Rotatable and reversibly expandable spinal hydraulic prosthetic device

• US 6,981,989 B1
• Filed: 04/22/2003
• Issued: 01/03/2006
• Est. Priority Date: 04/22/2003
• Status: Expired due to Fees

• Current Assignee: X-Pantu-Flex Drd Limited Liability Company
• Original Assignee: X-Pantu-Flex Drd Limited Liability Company
• Inventors: Fleischmann, Lewis W., Galuardi, Christopher
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US10/419,899
• Time in Patent Office: 987 Days
• Field of Search: 623/17.11, 623/17.12, 623/17.13, 623/17.14, 623/17.15, 623/17.16
• US Class Current: 623/17.11
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/441 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 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• 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 2002/30604 modular
• CPC Class Codes: A61F 2002/30639 having rolling elements between both articulating surfaces
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2002/4628 with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2310/00203 containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00317 containing silicon nitride

Abstract

An improved spinal intervertebral prosthetic device that offers all degrees of motion afforded by the anatomic spinal intervertebral disc, and by virtue of the incorporation of a dashpot assembly mechanism within reversibly displaceable bellows, provides hydraulic load bearing capability as well as limiting the maximum pressure that can be exerted on the bellows assembly by limiting the compression stroke of the device. The dashpot assembly also increases resistance to lateral shear loading in excess of the bellows convolutions acting alone. The spinal intervertebral prosthetic device absorbs varying axial loads via hydraulic pressure transfer to the bellows convolutions which can flex in a spring-like fashion. Rotational coupling of the upper crown plate and center bearings plate permits normal twisting movements, and spinal flexural freedom is provided by the bellows that are interposed between the center bearings plate and the lower crown plate.

Claims

1. A rotatable and reversibly expandable spinal hydraulic prosthetic device comprising:

(a) an upper crown plate member for engaging a vertebra;

(b) at least one center bearings plate member rotationally coupled to said upper crown plate member;

(c) a lower crown plate member for engaging a vertebra, coupled to said center bearing plate member;

(d) at least one reversibly displaceable bellows member having a fluid contained therein and sandwiched between said lower crown plate member and said center bearings plate member for resisting shearing force loads between said upper crown plate member and said lower crown plate member; and

,

(e) a dashpot mechanism interposed between said center bearings plate and said lower crown plate member for dampening shock loads.

2. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 1 wherein said upper crown plate includes a first vertebra engaging surface for joining said upper crown plate to a vertebra, and includes a second bearing surface opposing said first vertebra engaging surface.

3. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 2 wherein said second bearing surface of said upper crown plate member has an annular groove formed therein.

4. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 3 wherein said center bearings plate member has a first upper surface with an annular groove formed therein.

5. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 4 further comprising a bearings retainer seal member disposed between said upper crown plate member and said center bearings plate member, said bearings retainer seal member having a plurality of ball bearings annularly positioned thereon and received within said annular groove of said second bearing surface of said upper crown plate member and said annular groove of said center bearings plate member.

6. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 2 wherein said lower crown plate member has a first vertebra engaging surface for joining said lower crown plate to a vertebra, and includes a second opposing surface being connected to an end of said reversibly displaceable bellows member, said lower crown plate member having a fluid channel formed therethrough for permitting said displaceable bellows member to be filled with fluid and for evacuation of said fluid.

7. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 6 wherein said lower crown plate member includes a valve member in fluid communication with said fluid channel for selectively sealing said fluid channel.

8. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 6 wherein an extension tubing is coupled with said lower crown plate member for fluid adjustment of said reversibly displaceable bellows member.

9. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 6 wherein each of said first vertebra engaging surfaces of said upper crown plate member and said lower crown plate member has at least one fixation opening formed therethrough for receiving securing members, joining each to the other.

10. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 6 wherein said first vertebra engaging surfaces of the upper crown plate member and the lower crown plate member each includes a plurality of engaging members or spikes projecting therefrom for securing said first vertebra engaging surfaces of said upper crown plate member and said lower crown plate member to respective endplates of a patient'"'"'s successive vertebrae.

11. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 6 wherein said fluid channel is in fluid communication with a valve assembly.

12. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 11 wherein said valve assembly is positioned remotely from said lower crown plate member.

13. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 1 wherein said dashpot mechanism includes a dashpot element fixedly located on a surface of said center bearing plate member and seated in a non-contiguous manner within a dashpot recess that is formed in a corresponding surface of the lower crown plate member.

14. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 13 wherein a dashpot cavity is formed between said dashpot element and said dashpot recess, wherein said dashpot cavity is in fluid communication with the fluid within said bellows member.

15. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 1 including at least one bearing retainer seal member, said bearing retainer seal member having a radial thrust bearing assembly, said bearing retainer seal member being rotationally coupled to said upper crown plate member and said center bearings plate member.

16. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 15 wherein said bellows member firmly attaches to said center bearings plate on a first end thereof, said center bearings plate having a bearing recess formed on a second end therein, said bearing recess receiving said radial bearing assembly of said bearing retainer seal member, and said bearing retainer seal member being contiguous and rotatable with respect to said center bearings plate member.

17. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 1 wherein said fluid is an incompressible fluid.

18. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 1 wherein said bellows member is formed as one integral unit.

19. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 1 wherein said bellows member is formed from a plurality of washers joined each to the other.

20. The rotatable and reversibly expandable spinal hydraulic prosthetic device as recited in claim 1 wherein a patient'"'"'s adjacent vertebrae are adjustably distracted by selective in situ hydraulic filling of said reversibly displaceable bellows member.

21. A rotatable, flexible spinal hydraulic prosthetic device, comprising:

(a) an upper crown plate member for engaging a patient'"'"'s vertebra;

(b) a lower crown plate member coupled to said upper crown plate for engaging a patient'"'"'s vertebra;

(c) at least one center bearings plate member disposed between said upper crown plate member and said lower crown plate member, said center bearings plate member being rotationally coupled to said upper crown plate member;

(d) at least one set of biocompatible metallic bellows being positionally located between and coupled to said center bearings plate member and said lower crown plate member, said bellows containing a substantially incompressible biocompatible fluid, wherein said bellows is axially displaceable in response to axial force loads, and flexes laterally as well as in ventral or dorsal directions in response to bending loads;

(e) a dashpot mechanism interposed between said center bearings plate and said lower crown plate member; and

,

(f) at least one set of thrust and radial bearings disposed between said upper crown plate member and said center bearings plate member for permitting rotation of said upper crown plate member relative to said lower crown plate member in response to torque loads.

22. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 21 wherein said upper crown-plate includes a first vertebra engaging surface for joining said upper crown plate to a patient'"'"'s vertebra, and includes a second bearing surface opposing said first vertebra engaging surface.

23. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 22 wherein said lower crown plate member has a first vertebra engaging surface for joining said lower crown plate to a patient'"'"'s vertebra, and includes a second opposing surface being connected to an end of said bellows, said lower crown plate member having a fluid channel formed therethrough for permitting said bellows to be filled with said biocompatible fluid and for evacuation of said biocompatible fluid.

24. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 23 wherein said first vertebra engaging surfaces of the upper crown plate member and the lower crown plate member each includes a plurality of engaging members or spikes projecting therefrom for securing said first vertebra engaging surfaces of said upper crown plate member and said lower crown plate member to respective endplates of a patient'"'"'s successive vertebrae.

25. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 23 wherein each of said first vertebra engaging surfaces of said upper crown plate member and said lower crown plate member has at least one fixation opening formed therethrough for receiving securing members, joining each to the other.

26. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 23 wherein said dashpot mechanism includes a dashpot element fixedly located on a surface of said center bearing plate member and seated in a non-contiguous manner within a dashpot recess that is formed in said second surface of the lower crown plate member.

27. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 26 wherein a dashpot cavity is formed between said dashpot element and said dashpot recess, wherein said dashpot cavity is in fluid communication with said biocompatible fluid within said bellows.

28. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 22 further comprising at least one bearing retainer seal member, said bearing retainer seal member having a radial thrust bearing assembly, said bearing retainer seal member being rotationally coupled to said upper crown plate member and said center bearings plate member.

29. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 28, wherein said bellows firmly attaches to a said center bearings plate on a first end thereof, said center bearings plate having a bearing recess formed on a second end therein, said bearing recess receiving said radial thrust bearing assembly of said bearing retainer seal member, and said bearing retainer seal member being contiguous and rotatable with respect to said center bearings plate member.

30. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 28 wherein said second bearing surface of said upper crown plate member has an annular groove formed therein.

31. The rotatable, flexible spinal hydraulic prosthetic device as recited in claim 30 wherein said bearings retainer seal member has a plurality of ball bearings annularly positioned thereon and received within said annular groove of said second bearing surface of said upper crown plate member and said annular groove of said center bearings plate member.