SPINAL INTERBODY SPACERS

• US 20100016970A1
• Filed: 07/16/2009
• Published: 01/21/2010
• Est. Priority Date: 07/17/2008
• Status: Active Grant

• Current Assignee: MiMedx Processing Services LLC (Mimedx Group Incorporated)
• Original Assignee: Spinemedica, LLC (Mimedx Group Incorporated)
• Inventors: Tomko, Daniel, Kapitan, John, Denoziére, Guilhem, Nijenbanning, Gert
• Granted Patent: US 8,172,902 B2
• Time in Patent Office: Days
• US Class Current: 623/17.120
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30228 Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30286 barrel-shaped
• 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 2002/30354 Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30372 with additional means for limiting said translation
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30481 using a locking clip
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30546 for adjusting elasticity, flexibility, spring rate or mechanical tension
• 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 2002/30568 Multiple spring systems including two or more helical springs
• CPC Class Codes: A61F 2002/30571 Leaf springs
• CPC Class Codes: A61F 2002/30573 2-D spiral springs
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/30937 : with cut-outs
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• 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 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 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/0012 : for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• 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

Non-articulating semi-rigid spinal implants include upper and lower rigid endplates that define at least one aligned pair of rigid male and female members. The respective female member having an interior facing cavity and the respective male member facing toward the female cavity. At least one elastic member resides in each female member cavity. The device can include an optional housing with at least one bore for each of the at least one aligned pairs of female and male members. The housing bore is sized and configured to snugly encase each respective aligned pair of endplate male and female members while leaving an upper outer surface of the upper endplate and a lower outer surface of the lower endplate exposed.

Claims

1. A non-articulating semi-rigid spinal implant, comprising:

upper and lower rigid endplates that define at least one aligned pair of substantially rigid male and female members, a respective female member having an interior facing cavity and the respective male member facing toward the female cavity; and

at least one elastic member in communication with the male member and/or the female member cavity.

2. An implant according to claim 1, further comprising a housing residing between outermost portions of the upper and lower endplates, the housing having at least one bore, with one bore for each of the at least one aligned pairs of female and male members, the bore sized and configured to encase each respective aligned pair of endplate male and female members while leaving an upper outer surface of the upper endplate and a lower outer surface of the lower endplate exposed.

3. The implant of claim 2, wherein an upper and lower surface of the housing is unsealably engaged to interior surfaces of the endplates and at least one of the endplates is free to translate up and down a distance with respect to the housing.

4. The implant of claim 1, wherein the at least one aligned pair is a plurality of aligned pairs of male and female members.

5. The implant of claim 2, wherein the at least one aligned pair of male and female members is two aligned pairs and the at least one housing bore is two bores, one for each of the two aligned pairs of male and female members.

6. The implant of claim 1, wherein the upper endplate holds the male member and the lower endplate holds the female member, and wherein the male member extends a distance into the female cavity and contacts the elastic member whereby spinal loading forces exerted on the endplates compress the elastic member a distance between about 1-3 mm.

7. The implant of claim 2, wherein the housing is a unitary flexible solid polymer body.

8. The implant of claim 7, wherein the housing has a molded solid PVA body.

9. The implant of claim 1, wherein the at least one elastic member comprises a single flexible elastic plug for each female member cavity, and wherein the plug has a unitary solid polymer body with variable stiffness, customized stiffness or multiple different stiffnesses.

10. The implant of claim 2, wherein the female member includes a rib on an outer surface thereof, and wherein the bore of the housing includes a channel configured to engage the rib.

11. The implant of claim 1, wherein the upper and lower endplates include fluid apertures and channels that allow local fluid to hydrate the elastic member.

12. The implant of claim 1, further comprising substantially planar permeable membranes, at least one residing proximate corresponding upper and lower surfaces of the at least one elastic member.

13. The implant of claim 1, wherein the at least one elastic member comprises a solid molded PVA body.

14. The implant of claim 1, wherein the at least one elastic member comprises a spring and a polymer plug in each cavity in communication with a respective male and female member pair.

15. The implant of claim 1, wherein the at least one elastic member comprises a flexible elastic polymer plug attached to a lower end portion of the male member.

16. The implant of claim 1, wherein the at least one elastic member comprises at least one of the following:

an elastic flexible plug, a spring, a washer, an O-ring.

17. The implant of claim 1, wherein the at least one elastic member comprises a plurality of stacked dome disk spring washers.

18. The implant of claim 1, wherein the at least one elastic member comprises a plurality of closely spaced vertically stacked O-rings.

19. The implant of claim 1, wherein the upper endplate includes an upper portion with a surface that is configured to contact local bone and a second surface that is vertically spaced apart from and resides below the upper portion, the second surface being attached to the male member.

20. The implant of claim 1, wherein the lower endplate includes a lower portion with a surface that is configured to contact local bone and a second surface that is vertically spaced apart from and resides above from the lower portion, the second surface being attached to the female member.

21. The implant of claim 1, wherein the female member includes an interior substantially vertically extending through channel with a lower portion having a ledge, and wherein the male member includes a lower portion with a tapered end that abuts the female member ledge to lock the upper endplate to the lower endplate.

22. The implant of claim 1, wherein the upper endplate includes a wall extending downwardly with a finger that matably engages an upwardly extending wall of the lower endplate.

23. A surgical medical kit for a spinal fusion procedure for providing dynamic stabilization, comprising:

fixation hardware including at least one rod, plate and/or screws for attaching two adjacent vertebral levels together; and

a plurality of non-articulating semi-rigid interbody spacers including;

upper and lower rigid endplates that define at least one aligned pair of rigid male and female members, a respective female member having an interior facing cavity and the respective male member facing toward the female cavity; and

at least one resilient member in communication with each pair of female and male members.

24. The kit of claim 23, wherein the at least one resilient member includes at least one elastic member that resides in each female member cavity.

25. The kit of claim 23, wherein the interbody spacers further comprise a housing with at least one bore, one bore for each of the at least one aligned pairs of female and male members, the bore sized and configured to encase each respective aligned pair of endplate male and female members while leaving an upper outer surface of the upper endplate and a lower outer surface of the lower endplate exposed

26. The kit of claim 23, wherein the interbody spacer endplates snap-fit together to apply a pre-load onto the at least one resilient member.

27. A non-articulating semi-rigid PLIF or TLIF interbody spinal spacer, comprising:

upper and lower rigid endplates, one having two spaced apart male members and the other having two spaced apart female members, pairs of the male and female members being longitudinally aligned and slidably engaged, each female member having a cavity facing the respective male member; and

at least one elastic member in communication with the male and female members.

28. The spacer of claim 27, wherein the at least one elastic member includes at least one elastic member that resides at least partially in each female member cavity, and wherein the at least one elastic member includes at least one of a resilient plug, O-ring, coil spring or dome disk spring washer.

29. The spacer of claim 27, further comprising a unitary body flexible housing with two cavities extending therethrough in a longitudinal direction, one cavity for each of the aligned pairs of female and male members, a respective cavity sized and configured to snugly encase each respective aligned pair of endplate male and female members while leaving an upper outer surface of the upper endplate and a lower outer surface of the lower endplate exposed.

30. The spacer of claim 27, wherein the at least one elastic member comprises at least one plug, O-ring, coil spring or dome disk spring washer in communication with a lower portion of the male member and a resilient plug held in a lower portion of the female member cavity.

31. The spacer of claim 27, wherein the endplates have a snap-fit attachment configuration and cooperate to apply a pre-load onto the at least one elastic member held therebetween.

32-46. -46. (canceled)