Granted Patent B2

US 12,402,921 · App. 18/622,885 · Granted Sep 2, 2025

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

A61B17/7067A61B17/7065A61B17/7071

Abstract

Claims (116)

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 along a proximal-to-distal direction 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 engages the inferior spinous process and/or the inferior lamina;

wherein:

the implant comprises a body that is formed as a single piece, the body comprising a superior member and an inferior member that are joined at a proximal end of the body;

the proximal superior surface and the distal superior surface are on the superior member; and

the proximal inferior surface and the distal inferior surface are on the inferior member;

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.

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-to-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 threaded member;

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;

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-to-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.

5. The method of claim 1 , wherein:

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 the 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-to-distal direction; and

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

7. The method of claim 1 , wherein urging the distal superior surface and the distal inferior surface to move apart comprises causing the distal superior surface to engage the superior lamina and causing the distal inferior surface to engage the inferior lamina.

8. 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 along a proximal-to-distal direction 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 engages the inferior spinous process and/or the inferior lamina;

wherein:

the implant comprises a body that is formed as a single piece, the body comprising a superior member and an inferior member;

the proximal superior surface and the distal superior surface are on the superior member;

the proximal inferior surface and the distal inferior surface are on the inferior member;

the superior member and the inferior member each comprise a distal free end; and

urging the implant to move from the retracted configuration to the deployed configuration comprises causing distal free ends of the superior member and the inferior member to move apart.

9. The method of claim 8 , 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-to-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.

10. The method of claim 8 , wherein:

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 8 , wherein:

the implant further comprises a threaded member;

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;

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-to-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.

12. The method of claim 8 , wherein:

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

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

13. The method of claim 8 , wherein urging the distal superior surface and the distal inferior surface to move apart comprises causing the distal superior surface to engage the superior lamina and causing the distal inferior surface to engage the inferior lamina.

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 along a proximal-to-distal direction 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 lamina and the distal inferior surface engages the inferior lamina;

wherein:

the implant comprises a body that is formed as a single piece, the body comprising a superior member and an inferior member;

the distal superior surface is on the superior member; and

the distal inferior surface is on the inferior member;

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.

15. The method of claim 14 , 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-to-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.

16. The method of claim 14 , 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.

17. The method of claim 14 , wherein:

the implant further comprises a threaded member;

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;

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-to-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.

18. The method of claim 14 , wherein:

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

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

Assignments (2)

Continuity (4)

References Cited (14)