IP Library › Granted Patent US 11,944,355
Granted Patent B2
US 11,944,355 · App. 17/732,823 · Granted Apr 2, 2024

Interspinous-interlaminar stabilization systems and methods

Inventors: Cheng-Lun Soo (Oklahoma City, OK); Peter M. Harris (Boca Raton, FL); Robert Bombach (Edmond, OK); James Q Spitler (Winter Garden, FL); Luis A. Escobar, III (Boca Raton, FL)
Assignee: FloSpine, LLC
A61B17/7067A61B17/7065A61B17/7074
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Quick Facts
Patent No.
US 11,944,355
App. No.
17/732,823
Granted
Apr 2, 2024
Kind
B2
Abstract

Systems and methods are disclosed for maintaining spacing between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina of adjacent vertebrae of a spine. A system may include an implant having a proximal superior surface with a superior concavity shaped to receive the superior spinous process, a proximal inferior surface with an inferior concavity shaped to receive the inferior spinous process, a distal superior surface, distal to the proximal superior surface, that faces the superior lamina, and a distal inferior surface, distal to the proximal inferior surface, that faces the inferior lamina. The implant may further have a threaded member extending along a proximal-distal direction, that rotates to urge the implant to move from a retracted configuration to a deployed configuration by urging the distal superior surface and the distal inferior surface to move apart.

Claims (173)

1. A method for implanting an implant in a space between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina of adjacent vertebrae of a spine, the method comprising:

with the implant in a retracted configuration, inserting the implant into the space such that a proximal superior surface of the implant engages the superior spinous process and a proximal inferior surface of the implant engages the inferior spinous process; and

urging the implant to move from the retracted configuration to a deployed configuration by urging a distal superior surface, distal to the proximal superior surface, and a distal inferior surface, distal to the proximal inferior surface, to move apart such that the distal superior surface engages the superior spinous process and/or the superior lamina and the distal inferior surface moves into engagement with the inferior lamina;

wherein a width of the implant along a medial-lateral direction remains constant as the implant moves from the retracted configuration to the deployed configuration.

2. The method of claim 1 , wherein:

the implant further comprises:

two superior wings extending superiorly from the proximal superior surface; and

two inferior wings extending inferiorly from the proximal superior surface;

the superior wings have superior tips;

the inferior wings have inferior tips;

the superior tips are displaced, along the proximal-distal direction, from the inferior tips; and

inserting the implant into the space comprises:

causing the superior spinous process to be received between the superior wings; and

causing the inferior spinous process to be received between the inferior wings.

3. The method of claim 1 , wherein:

the implant comprises a wingless shape; and

inserting the implant into the space comprises inserting the implant through a cannula to pass the implant through soft tissues posterior to the space.

4. The method of claim 1 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the superior member is shaped to define a superior living hinge;

the inferior member is shaped to define an inferior living hinge; and

urging the implant to move from the retracted configuration to the deployed configuration comprises:

rotating the distal superior surface superiorly, relative to the proximal superior surface via the superior living hinge; and

rotating the distal inferior surface inferiorly, relative to the proximal inferior surface, via the inferior living hinge.

5. The method of claim 1 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the superior member is formed as a single piece with the inferior member;

the implant further comprises two laterally-facing surfaces, each of which extends between the superior member and the inferior member and defines an aperture;

the apertures cooperate to define an inserter interface; and

the method further comprises:

prior to inserting the implant into the space, coupling the implant to an inserter via the inserter interface; and

after moving the implant from the retracted configuration to a deployed configuration, detaching the implant from the inserter.

6. The method of claim 1 , wherein:

the distal superior surface and the distal inferior surface each comprises a ridge extending along a lateral direction transverse to the proximal-distal direction; and

moving the implant from the retracted configuration to a deployed configuration comprises causing the ridges to contact the superior spinous process and/or the superior lamina and the inferior lamina.

7. The method of claim 1 , wherein urging the implant to move from the retracted configuration to the deployed configuration comprises rotating a threaded member extending along a proximal-distal direction.

8. The method of claim 7 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the cavity comprises a proximal end and a distal end;

urging the implant to move from the retracted configuration to the deployed configuration comprises moving a threaded block, in response to rotation of the threaded member, from the proximal end to the distal end toward the distal end;

the cavity is shaped such that, in the retracted configuration, the proximal end is wider than the distal end along a superior-inferior direction transverse to the proximal-distal direction; and

moving the threaded block toward the distal end comprises widening the distal end to urge the distal superior surface and the distal inferior surface to move apart.

9. A method for implanting an implant in a space between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina of adjacent vertebrae of a spine, the method comprising:

with the implant in a retracted configuration, inserting the implant into the space such that a proximal superior surface of the implant engages the superior spinous process and a proximal inferior surface of the implant engages the inferior spinous process; and

urging the implant to move from the retracted configuration to a deployed configuration by urging a distal superior surface, distal to the proximal superior surface, and a distal inferior surface, distal to the proximal inferior surface, to move apart while more than the proximal superior surface and the proximal inferior surface remain in place relative to each other.

10. The method of claim 9 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the superior member is shaped to define a superior living hinge;

the inferior member is shaped to define an inferior living hinge; and

urging the implant to move from the retracted configuration to the deployed configuration comprises:

rotating the distal superior surface superiorly, relative to the proximal superior surface via the superior living hinge; and

rotating the distal inferior surface inferiorly, relative to the proximal inferior surface, via the inferior living hinge.

11. The method of claim 9 , wherein urging the implant to move from the retracted configuration to the deployed configuration comprises rotating a threaded member extending along a proximal-distal direction.

12. The method of claim 11 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the cavity comprises a proximal end and a distal end;

urging the implant to move from the retracted configuration to the deployed configuration comprises moving a threaded block, in response to rotation of the threaded member, from the proximal end to the distal end toward the distal end;

the cavity is shaped such that, in the retracted configuration, the proximal end is wider than the distal end along a superior-inferior direction transverse to the proximal-distal direction; and

moving the threaded block toward the distal end comprises widening the distal end to urge the distal superior surface and the distal inferior surface to move apart.

13. The method of claim 9 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the superior member is formed as a single piece with the inferior member;

the implant further comprises two laterally-facing surfaces, each of which extends between the superior member and the inferior member and defines an aperture;

the apertures cooperate to define an inserter interface; and

the method further comprises:

prior to inserting the implant into the space, coupling the implant to an inserter via the inserter interface; and

after moving the implant from the retracted configuration to a deployed configuration, detaching the implant from the inserter.

14. A method for implanting an implant in a space between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina of adjacent vertebrae of a spine, the method comprising:

with the implant in a retracted configuration, inserting the implant into the space such that a distal end of the implant is positioned between the inferior lamina and the superior lamina, a proximal superior surface of the implant engages the superior spinous process, and a proximal inferior surface of the implant engages the inferior spinous process; and

urging the implant to move from the retracted configuration to a deployed configuration by urging a distal superior surface, distal to the proximal superior surface, and a distal inferior surface, distal to the proximal inferior surface, to move apart such that the distal superior surface engages the superior spinous process and/or the superior lamina and the distal inferior surface engages the inferior spinous process and/or the inferior lamina;

wherein:

in the retracted configuration, the implant comprises a block; and

urging the implant to move from the retracted configuration to the deployed configuration comprises moving the block distally between the distal superior surface and the distal inferior surface.

15. The method of claim 14 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the superior member is shaped to define a superior living hinge;

the inferior member is shaped to define an inferior living hinge; and

urging the implant to move from the retracted configuration to the deployed configuration comprises:

rotating the distal superior surface superiorly, relative to the proximal superior surface via the superior living hinge; and

rotating the distal inferior surface inferiorly, relative to the proximal inferior surface, via the inferior living hinge.

16. The method of claim 14 , wherein urging the implant to move from the retracted configuration to the deployed configuration comprises rotating a threaded member extending along a proximal-distal direction.

17. The method of claim 14 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the superior member is formed as a single piece with the inferior member;

the implant further comprises two laterally-facing surfaces, each of which extends between the superior member and the inferior member and defines an aperture;

the apertures cooperate to define an inserter interface; and

the method further comprises:

prior to inserting the implant into the space, coupling the implant to an inserter via the inserter interface; and

after moving the implant from the retracted configuration to a deployed configuration, detaching the implant from the inserter.

18. A method for implanting an implant in a space between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina of adjacent vertebrae of a spine, the method comprising:

with the implant in a retracted configuration, inserting the implant into the space such that a proximal superior surface of the implant engages the superior spinous process, a proximal inferior surface of the implant engages the inferior spinous process, and posterior aspects of the superior spinous process and the inferior spinous process remain fully exposed; and

urging the implant to move from the retracted configuration to a deployed configuration by urging a distal superior surface, distal to the proximal superior surface, and a distal inferior surface, distal to the proximal inferior surface, to move apart such that the distal superior surface engages the superior spinous process and/or the superior lamina and the distal inferior surface engages the inferior spinous process and/or the inferior lamina;

wherein:

the implant defines a cavity between the distal superior surface and the distal inferior surface, the cavity having a proximal end and a distal end;

the cavity is shaped such that, in the retracted configuration, the proximal end is wider than the distal end along a superior-inferior direction transverse to the proximal-distal direction; and

urging the implant to move from the retracted configuration to the deployed configuration comprises moving a block distally between the distal superior surface and the distal inferior surface.

19. The method of claim 18 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the superior member is shaped to define a superior living hinge;

the inferior member is shaped to define an inferior living hinge; and

urging the implant to move from the retracted configuration to the deployed configuration comprises:

rotating the distal superior surface superiorly, relative to the proximal superior surface via the superior living hinge; and

rotating the distal inferior surface inferiorly, relative to the proximal inferior surface, via the inferior living hinge.

20. The method of claim 18 , wherein urging the implant to move from the retracted configuration to the deployed configuration comprises rotating a threaded member extending along a proximal-distal direction.

21. The method of claim 18 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the superior member is formed as a single piece with the inferior member;

the implant further comprises two laterally-facing surfaces, each of which extends between the superior member and the inferior member and defines an aperture;

the apertures cooperate to define an inserter interface; and

the method further comprises:

prior to inserting the implant into the space, coupling the implant to an inserter via the inserter interface; and

after moving the implant from the retracted configuration to a deployed configuration, detaching the implant from the inserter.

22. A method for implanting an implant in a space between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina of adjacent vertebrae of a spine, the method comprising:

with the implant in a retracted configuration, inserting the implant into the space such that a proximal superior surface of the implant engages the superior spinous process and a proximal inferior surface of the implant engages the inferior spinous process;

urging the implant to flex such that the implant moves from the retracted configuration to a deployed configuration to expand a distalmost end of the implant by urging a distal superior surface, distal to the proximal superior surface, and a distal inferior surface, distal to the proximal inferior surface, to move apart such that the distal superior surface engages the superior spinous process and/or the superior lamina and the distal inferior surface engages the inferior spinous process and/or the inferior lamina; and

with a block positioned between the distal superior surface and the distal inferior surface, retaining the implant in the deployed configuration by blocking motion of the distal superior surface toward the distal inferior surface.

23. The method of claim 22 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the superior member is shaped to define a superior living hinge;

the inferior member is shaped to define an inferior living hinge; and

urging the implant to move from the retracted configuration to the deployed configuration comprises:

rotating the distal superior surface superiorly, relative to the proximal superior surface via the superior living hinge; and

rotating the distal inferior surface inferiorly, relative to the proximal inferior surface, via the inferior living hinge.

24. The method of claim 22 , wherein urging the implant to move from the retracted configuration to the deployed configuration comprises rotating a threaded member extending along a proximal-distal direction.

25. The method of claim 24 , wherein:

the block comprises a threaded block;

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the implant defines a cavity between the superior member and the inferior member;

the cavity comprises a proximal end and a distal end;

urging the implant to move from the retracted configuration to the deployed configuration comprises moving the threaded block, in response to rotation of the threaded member, from the proximal end to the distal end toward the distal end;

the cavity is shaped such that, in the retracted configuration, the proximal end is wider than the distal end along a superior-inferior direction transverse to the proximal-distal direction; and

moving the threaded block toward the distal end comprises widening the distal end to urge the distal superior surface and the distal inferior surface to move apart.

26. The method of claim 22 , wherein:

the implant further comprises:

a superior member on which the proximal superior surface and the distal superior surface reside; and

an inferior member on which the proximal inferior surface and the distal inferior surface reside;

the superior member is formed as a single piece with the inferior member;

the implant further comprises two laterally-facing surfaces, each of which extends between the superior member and the inferior member and defines an aperture;

the apertures cooperate to define an inserter interface; and

the method further comprises:

prior to inserting the implant into the space, coupling the implant to an inserter via the inserter interface; and

after moving the implant from the retracted configuration to a deployed configuration, detaching the implant from the inserter.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 27, 2026
From: FLOSPINE, LLC
To: AMPLIO SPINE, LLC
Reel/Frame 075110/0633 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 29, 2022
From: SOO, CHENG-LUN; HARRIS, PETER M.; BOMBACH, ROBERT; SPITLER, JAMES Q.; ESCOBAR, LUIS A.
To: FLOSPINE, LLC
Reel/Frame 059773/0950 →
Continuity (3)
Division 17000033 · Aug 21, 2020
Provisional Application 62889719 · Aug 21, 2019
Related Publication 20220249135A1 · Aug 11, 2022
Cited By (1)
US 12,402,921