Intervertebral disc implant

• US 9,693,872 B2
• Filed: 01/08/2016
• Issued: 07/04/2017
• Est. Priority Date: 09/15/2006
• Status: Active Grant

• Current Assignee: Xtant Medical Holdings, Inc. (OrbiMed Advisors LLC (China))
• Original Assignee: Pioneer Surgical Technology Incorporated (Surgalign Holdings, Inc.)
• Inventors: Trudeau, Jeffrey L., Janowski, Brian Patrick, Jackson, Michael R., Bao, Qi-Bin, Kilpela, Thomas
• Primary Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US14/991,191
• Publication Number:
  US 20160120657A1
• Time in Patent Office: 543 Days
• Field of Search: 623 1711- 1716
• 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 2/4425 made of articulated components
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30112 Rounded shapes, e.g. with rounded corners
• 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 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30393 with additional means for limiting said rotation
• CPC Class Codes: A61F 2002/30485 plastically deformable
• CPC Class Codes: A61F 2002/30492 using a locking pin
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30571 Leaf springs
• 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 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30662 : with rotation-limiting means
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30823 : having the shape of a reverse dovetail
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30845 : with cutting edges
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30899 : Protrusions pierced with apertures
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• 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 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Abstract

Systems and tools for inserting and securing an implant within the intervertebral space. An intervertebral disc implant with upper and lower bearing members with an articulation interface between the members for providing relative motion therebetween. The implant may be provided with various securing members for fixing the implant within the intervertebral space. A tool may be used to insert the implant, which includes a plurality of shiftable implant engaging members that are shiftable between non-engaging and engaging configurations to alternatively release or hold the implant.

Claims

1. An intervertebral disc implant for being inserted between adjacent upper and lower vertebral bones, comprising:

an upper bearing member;

a lower bearing member;

a body of the upper bearing member having an outer bearing surface for being disposed adjacent the upper vertebral bone;

a body of the lower bearing member having an outer bearing surface for being disposed adjacent the lower vertebral bone;

an articulation interface between the upper and lower bearing members for allowing relative movement therebetween with the bearing members configured to fit in an intervertebral space between upper and lower vertebral bones;

a rotary securing member rotatably mounted to one of the bearing members to be carried by the one bearing member, so that the rotary securing member extends along the outer bearing surface of the one bearing member prior to being inserted into the intervertebral space, and is inserted together with the one bearing member into the intervertebral space, and after insertion of the rotary securing member and the one bearing member into the intervertebral space, the rotary securing member is arranged for being rotated for securing the one bearing member to the adjacent vertebral bone;

a rotary shaft of the securing member having a longitudinal axis; and

a plurality of spaced-apart plate-like bone-engaging portions extending generally transversely from the rotary shaft and each including a distal arc-shaped edge portion spaced from the rotary shaft such that rotation of the rotary shaft about the longitudinal axis causes a corresponding rotation of the bone-engaging portions about the longitudinal axis to allow the rotary shaft of the rotary securing member to be rotated from an undeployed orientation with the bone-engaging portions out of engagement with the adjacent vertebral bone and a deployed orientation with the bone-engaging portions including the distal arc-shaped edge portions thereof in imbedded engagement with the adjacent vertebral bone;

wherein each of the plurality of plate-like bone-engaging portions has opposing side face portions extending orthogonally from the rotary shaft relative to the longitudinal axis thereof and the distal arc-shaped edge portion spaced from the rotary shaft is disposed at an outermost extent of the opposing side portions.

2. The intervertebral disc implant of claim 1, wherein the plurality of spaced plate-like bone-engaging portions include first, second, and third bone-engaging portions each fixedly disposed on the rotary shaft and spaced apart along the longitudinal axis from the other bone engaging portions for engaging with the adjacent vertebral bone to secure the one bearing member relative thereto.

3. The intervertebral disc implant of claim 1, wherein when in the undeployed orientation, the plurality of bone-engaging portions are disposed within the body of the one bearing member such that they do not protrude outside of the outer bearing surface thereof.

4. The intervertebral disc implant of claim 1, wherein the body includes a plurality of spaced apart recesses sized and configured to receive the corresponding plurality of bone-engaging portions when the bone-engaging portions are in the undeployed orientation.

5. The intervertebral disc implant of claim 1, wherein the securing member is connected to the one bearing member via a friction fit.

6. The intervertebral disc implant of claim 1, wherein at least one securing member is disposed on each of the upper and lower bearing members for fixing the bearing members relative to the adjacent vertebral bones.

7. The intervertebral disc implant of claim 1, wherein the plurality of bone-engaging portions are formed on the rotary shaft, such that each rotary securing member is monolithic.

8. The intervertebral disc implant of claim 1, wherein the distal arc-shaped edge portion subtends an angle of at least 90 degrees.

9. An intervertebral disc implant for being inserted between adjacent upper and lower vertebral bones, comprising:

an upper bearing member;

a lower bearing member;

a body of the upper bearing member having an outer bearing surface for being disposed adjacent the upper vertebral bone;

a body of the lower bearing member having an outer bearing surface for being disposed adjacent the lower vertebral bone;

an articulation interface between the upper and lower bearing members for allowing relative movement therebetween with the bearing members configured to fit in an intervertebral space between upper and lower vertebral bones;

a rotary securing member rotatably mounted to one of the bearing members to be carried by the one bearing member, so that the rotary securing member extends along the outer bearing surface of the one bearing member prior to being inserted into the intervertebral space, and is inserted together with the one bearing member into the intervertebral space, and after insertion of the rotary securing member and the one bearing member into the intervertebral space, the rotary securing member is arranged for being rotated for securing the one bearing member to the adjacent vertebral bone;

a rotary shaft of the securing member having a longitudinal axis; and

a plurality of spaced-apart plate-like bone-engaging portions extending generally transversely from the rotary shaft and each including a distal arc-shaped edge portion spaced from the rotary shaft such that rotation of the rotary shaft about the longitudinal axis causes a corresponding rotation of the bone-engaging portions about the longitudinal axis to allow the rotary shaft of the rotary securing member to be rotated from an undeployed orientation with the bone-engaging portions out of engagement with the adjacent vertebral bone and a deployed orientation with the bone-engaging portions including the distal arc-shaped edge portions thereof in imbedded engagement with the adjacent vertebral bone;

wherein the plate-like bone-engaging portions each comprise a leading cutting edge that extends outwardly from the rotary shaft in a direction transverse to the longitudinal axis of the rotary shaft and terminates at the distal arc-shaped edge portion for cutting into the adjacent vertebral bone and leading the distal arc-shaped edge portion into the cut adjacent vertebral bone as the bone-engaging portion is rotated into the deployed orientation to create a groove in the adjacent vertebral bone sized to fit the bone-engaging portion therein.

10. The intervertebral disc implant of claim 9, wherein the plurality of plate-like bone-engaging portions extend transversely to the longitudinal axis of the rotary shaft and are parallel to one another.

11. An intervertebral disc implant for being inserted between adjacent upper and lower vertebral bones, comprising:

an upper bearing member;

a lower bearing member;

a body of the upper bearing member having an outer bearing surface for being disposed adjacent the upper vertebral bone;

a body of the lower bearing member having an outer bearing surface for being disposed adjacent the lower vertebral bone;

an articulation interface between the upper and lower bearing members for allowing relative movement therebetween with the bearing members configured to fit in an intervertebral space between upper and lower vertebral bones;

a rotary securing member rotatably mounted to one of the bearing members to be carried by the one bearing member, so that the rotary securing member extends along the outer bearing surface of the one bearing member prior to being inserted into the intervertebral space, and is inserted together with the one bearing member into the intervertebral space, and after insertion of the rotary securing member and the one bearing member into the intervertebral space, the rotary securing member is arranged for being rotated for securing the one bearing member to the adjacent vertebral bone;

a rotary shaft of the securing member having a longitudinal axis;

a plurality of spaced-apart plate-like bone-engaging portions extending generally transversely from the rotary shaft and each including a distal arc-shaped edge portion spaced from the rotary shaft such that rotation of the rotary shaft about the longitudinal axis causes a corresponding rotation of the bone-engaging portions about the longitudinal axis to allow the rotary shaft of the rotary securing member to be rotated from an undeployed orientation with the bone-engaging portions out of engagement with the adjacent vertebral bone and a deployed orientation with the bone-engaging portions including the distal arc-shaped edge portions thereof in imbedded engagement with the adjacent vertebral bone; and

a securing member receiving portion extending outwardly from the outer bearing surface of the one bearing member having at least one pair of opposed arms that extend beyond the outer bearing surface and having opposing inner arcuate surface portions for retaining the rotary shaft therebetween with a friction fit.

12. The intervertebral disc implant of claim 11, wherein the securing member receiving portion includes at least two pairs of opposed arms for retaining the securing member therebetween, wherein one of the plurality of bone-engaging portions is disposed between the two pairs of opposed arms for providing a path for which the bone engaging member may travel between the undeployed and the deployed orientations.

13. An intervertebral disc implant, comprising:

an upper bearing member;

a lower bearing member;

a body of the upper bearing member having an outer bearing surface for being disposed adjacent the upper vertebral bone;

a body of the lower bearing member having an outer bearing surface for being disposed adjacent the lower vertebral bone;

an articulation interface between the upper and lower bearing members for allowing relative movement therebetween;

a rotary securing member rotatably mounted to one of the bearing members for being rotated for securing the one bearing member to the adjacent vertebral bone;

a rotary shaft of the securing member having a longitudinal axis; and

a securing member receiving portion of the one bearing member having at least one pair of opposed arms extending outwardly from so as to extend beyond the outer bearing surface, and the at least one pair of opposed arms having a gap therebetween for receiving the rotary shaft and the gap being sized so that the at least one pair of opposed arms have a friction fit with the rotary shaft to retain the rotary shaft therein with at least a portion of the securing member extending beyond the outer bearing surface prior to the rotary securing member being rotated for securing the one bearing member to the adjacent vertebral bone.

14. The intervertebral disc implant of claim 13, wherein the securing member includes a plate-like bone-engaging portion extending from the rotary shaft configured to be rotated from an undeployed orientation with the bone-engaging portion disposed within the body of the bearing member and out of engagement with the adjacent vertebral bone and a deployed orientation with the bone-engaging portion in engagement with the adjacent vertebral bone and the bone-engaging portion being configured such that rotation of the rotary shaft from the undeployed orientation to the deployed orientation does not cause the rotary shaft to advance along the longitudinal axis thereof and the outer bearing surface.

15. The intervertebral disc implant of claim 13, wherein the securing member receiving portion further comprises a second pair of opposed arms extending from the outer bearing surface having a gap therebetween for receiving the rotary shaft therein with the second pair of opposed arms retaining the securing member therebetween with a friction fit, the second pair of opposed arms spaced along the longitudinal axis of the rotary shaft from the at least one pair of opposed arms.

16. The intervertebral disc implant of claim 13, wherein the rotary shaft has a length, and the securing member receiving portion includes a channel defined in part by the gap between the at least one pair of opposed arms for receiving the rotary shaft, the rotary shaft being disposed at least partially within the channel with the channel extending along at least a majority of the length of the rotary shaft.

17. The intervertebral disc implant of claim 13, wherein the one bearing member has a transversely oriented recess in communication with the outer bearing surface thereof disposed generally transversely to the longitudinal axis of the rotary shaft for receiving a bone-engaging portion of the securing member in an undeployed orientation.

18. The intervertebral disc implant of claim 13, further comprising a plurality of spaced plate-like bone-engaging portions extending generally transversely from the rotary shaft such that rotation of the rotary shaft about the longitudinal axis causes a corresponding rotation of the bone engaging portions about the longitudinal axis to allow the rotary shaft of the rotary securing member to be rotated from an undeployed orientation with the bone-engaging portions out of engagement with the adjacent vertebral bone and a deployed orientation with the bone-engaging portions in imbedded engagement with the adjacent vertebral bone.

19. An intervertebral disc implant, comprising:

an upper bearing member;

a lower bearing member;

a body of the upper bearing member having an outer bearing surface for being disposed adjacent the upper vertebral bone;

a body of the lower bearing member having an outer bearing surface for being disposed adjacent the lower vertebral bone;

an articulation interface between the upper and lower bearing members for allowing relative movement therebetween;

a rotary securing member rotatably mounted to one of the bearing members for being rotated for securing the one bearing member to the adjacent vertebral bone;

a rotary shaft of the securing member having a longitudinal axis; and

a securing member receiving portion of the one bearing member having at least one pair of opposed arms extending outwardly from the outer bearing surface, and the at least one pair of opposed arms having a gap therebetween for receiving the rotary shaft and the gap being sized so that the at least one pair of opposed arms have a friction fit with the rotary shaft to retain the rotary shaft therein;

wherein the rotary shaft is configured to be rotated approximately 180 degrees from an undeployed orientation to a deployed orientation.