IP Library Granted Patent US 9,522,018
Granted Patent B2
US 9,522,018 · App. 14/585,097 · Granted Dec 20, 2016

Posterior functionally dynamic stabilization system

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Quick Facts
Patent No.
US 9,522,018
App. No.
14/585,097
Granted
Dec 20, 2016
Kind
B2
Abstract

A functionally dynamic stabilization unit and system for treatment of spinal instability are provided. Each unit, and collectively, the system, is configured to control flexion, extension and translation of the affected unstable vertebral area, thereby stabilizing the vertebral segments by restoring normal function. This is achieved by providing a unit and system that allow for lateral bending, axial compression, rotation, anterior segmental height adjustment, and posterior segmental height adjustment. The unit and system provide sufficient segmental stiffness, while also limiting, or controlling, the range of motion (i.e., sufficient stiffness in the neutral or active zone, while limiting or preventing motion outside of the active zone) to stabilize the vertebral segments. In use, the system mimics the natural movement of the normal spine. Furthermore, the system includes a rigid, fusion-promoting coupler configured for use in an adjacent level, or as a substitute for the functionally dynamic unit. The modularity of the system allows adjustment over time and easier revision surgery, and is configured for minimally-invasive, delivery or implantation.

Claims (34)

1. A spinal stabilization unit, comprising:

a flexible coupler having a body, a pair of arms, the arms being located at opposed ends of the coupler, and a range-of-motion limiting mechanism configured to control an amount of bending, an amount of compression, and an amount of extension of the coupler; and

an anchoring system including a plurality of bone anchors configured to cooperate with the arms of the flexible coupler to attach the coupler to bone;

wherein the range-of-motion limiting mechanism comprises a sleeve extending internally from a first end of the coupler towards a second end of the coupler and having a narrowed distal opening, and an elongated body extending internally from the second end of the coupler towards the first end of the coupler and having an enlarged end disposed within the sleeve and dimensioned such that the enlarged end abuts the wall of the narrowed opening when the coupler is elongated or bent, and the sleeve abuts the second end of the coupler when the coupler is compressed.

2. The unit of claim 1 , wherein at least one of the arms is connected to the body of the flexible coupler at a threaded connection.

3. The unit of claim 1 , wherein the body is flexible.

4. The unit of claim 1 , wherein the body is extendable and compressible along a longitudinal axis of the body.

5. The unit of claim 1 , wherein the body is bendable along its long axis.

6. The unit of claim 5 , wherein each arm includes a concave portion having an opening, and the anchoring system further includes a semispherical bell bearing for each bone anchor.

7. The unit of claim 6 , wherein the flexible coupler is movable relative to the plurality of bone anchors.

8. The unit of claim 1 , wherein the body is cylindrical and includes a plurality of elements forming slots within the body.

9. The unit of claim 1 , wherein a length of the flexible coupler is adjustable.

10. The unit of claim 9 , wherein one of the arms is attached to the coupler at a threaded connection, and the length of the coupler can be adjusted by rotation of the arm with respect to the threaded connection.

11. The unit of claim 1 , wherein the movement of the elongate body relative to the sleeve in a first direction defines a range of extension of the coupler, and movement of the elongate body relative to the sleeve in a second direction, opposite to the first direction, defines a range of compression of the coupler.

12. The unit of claim 1 , wherein the bone anchoring system further includes at least one ball bearing and at least one nut.

13. The unit of claim 1 , wherein the flexible coupler is configured to be movable relative to the anchoring system.

14. The unit of claim 1 , wherein the anchoring system further includes a plurality of nuts, each nut having a narrowed break-away portion configured to break when sufficient torque is applied to the nut.

15. The unit of claim 1 , wherein the range-of-motion limiting mechanism is located within the body.

16. A method of implanting a spinal stabilization unit, comprising:

providing at least one incision over at least two adjacent vertebrae to be treated;

positioning at least two wires into pedicles such that each wire separately contacts a pedicle of one of the at least two vertebrae;

securing a screw to each of the first and second adjacent vertebrae to be treated;

adjusting a length of a flexible coupler to fit between two of the screws; and

attaching the flexible coupler to the two screws of the first and second adjacent vertebrae.

17. The method of claim 16 , further including measuring the distance between the screws secured to the two adjacent vertebrae.

18. The method of claim 16 , wherein adjusting the length of the flexible coupler includes rotating an arm of flexible coupler to adjust an amount the arm extends from a body portion of the flexible coupler.

19. The method of claim 16 , further comprising:

providing at least one incision over a third vertebra to be treated;

positioning at least one wire into a pedicle of the third vertebra such that the wire separately contacts the pedicle of the third vertebra;

securing a screw to the third vertebra to be treated; and

attaching a rigid coupler to the screw of the third vertebra, and to one of the screws of the first and second vertebrae.

20. The method of claim 19 , further including measuring the distance between the screw of the third vertebra and to one of the screws of the first and second vertebrae.

21. The method of claim 20 , further adjusting a length of the rigid coupler to fit between the screw of the third vertebra and to one of the screws of the first and second vertebrae.

22. The method of claim 21 , wherein adjusting the length of the rigid coupler includes rotating an arm of the rigid coupler to adjust an amount the arm extends from the rigid coupler.

Assignments (14)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 27, 2026
From: XTANT MEDICAL HOLDINGS, INC.; SURGALIGN SPV, INC.
To: COMPANION SPINE FRANCE SAS
Reel/Frame 073926/0577 →
SECURITY INTEREST Recorded Aug 11, 2024
From: XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.; SURGALIGN SPV, INC.; XTANT MEDICAL HOLDINGS, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 068539/0665 →
SECURITY INTEREST Recorded Aug 11, 2024
From: XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.; SURGALIGN SPV, INC.; XTANT MEDICAL HOLDINGS, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 068539/0492 →
SECURITY AGREEMENT SUPPLEMENT (TERM) Recorded Dec 22, 2023
From: XTANT MEDICAL HOLDINGS, INC.; XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 066095/0635 →
SECURITY AGREEMENT SUPPLEMENT (REVOLVING) Recorded Dec 22, 2023
From: XTANT MEDICAL HOLDINGS, INC.; XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 066095/0652 →
MERGER Recorded Dec 12, 2023
From: PARADIGM SPINE, LLC
To: SPINAL TRANSITION AND PROFESSIONAL SERVICES LLC
Reel/Frame 065847/0610 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2023
From: SPINAL TRANSITION AND PROFESSIONAL SERVICES LLC
To: XTANT MEDICAL HOLDINGS, INC.
Reel/Frame 065849/0613 →
RELEASE OF SECURITY INTEREST Recorded Jul 21, 2020
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: PARADIGM SPINE, LLC; FOURTH DIMENSION SPINE, LLC
Reel/Frame 053260/0156 →
RELEASE OF SECURITY INTEREST Recorded Jul 20, 2020
From: ARES CAPITAL CORPORATION, AS AGENT
To: RTI SURGICAL, INC.; PIONEER SURGICAL TECHNOLOGY, INC.; TUTOGEN MEDICAL, INC.; PARADIGM SPINE, LLC; FOURTH DIMENSION SPINE, LLC
Reel/Frame 053257/0652 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Aug 30, 2019
From: HAYFIN SERVICES LLP
To: PARADIGM SPINE, LLC
Reel/Frame 050236/0828 →
RELEASE OF SECURITY INTEREST Recorded Mar 12, 2019
From: HAYFIN SERVICES LLP, AS ADMINISTRATIVE AGENT
To: PARADIGM SPINE, LLC
Reel/Frame 050426/0001 →
SECURITY INTEREST Recorded Mar 8, 2019
From: PARADIGM SPINE, LLC; FOURTH DIMENSION SPINE, LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 048538/0026 →
SECURITY INTEREST Recorded Mar 8, 2019
From: RTI SURGICAL, INC.; PIONEER SURGICAL TECHNOLOGY, INC.; TUTOGEN MEDICAL, INC.; PARADIGM SPINE, LLC; FOURTH DIMENSION SPINE, LLC
To: ARES CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT
Reel/Frame 048543/0505 →
SECURITY INTEREST Recorded Aug 26, 2016
From: PARADIGM SPINE, LLC
To: HAYFIN SERVICES LLP
Reel/Frame 039842/0877 →