IP Library Granted Patent US 12,390,346
Granted Patent B2
US 12,390,346 · App. 18/411,956 · Granted Aug 19, 2025

Methods of stabilizing an intervertebral scaffolding system

Inventors: John To (Newark, CA); John J. Flynn (Walnut Creek, CA)
Assignee: INTEGRITY IMPLANTS INC.
A61F2/447A61F2/442A61F2/4455A61F2/4611A61F2002/2835A61F2002/30471A61F2002/30476A61F2002/30545A61F2002/30556A61F2002/30579A61F2002/4677
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Quick Facts
Patent No.
US 12,390,346
App. No.
18/411,956
Granted
Aug 19, 2025
Kind
B2
Abstract

An intervertebral scaffolding system is provided having a laterovertically-expanding frame operable for a reversible collapse from an expanded state into a collapsed state, the laterovertically-expanding frame having a stabilizer that slidably engages with the distal region of the laterovertically-expanding frame and is configured for retaining the laterovertically-expanding frame from a lateral movement that exceeds the expanded state. The expanded state, for example, can be configured to have an open graft distribution window that at least substantially closes upon the reversible collapse.

Claims (70)

1. A method of stabilizing a laterally-expandable intervertebral scaffolding in a subject, the method comprising:

obtaining a laterally-expandable intervertebral scaffolding having a plurality of support beams each beam in the plurality of support beams (i) designed to bear a compression load in the cephalocaudal direction in a subject and (ii) independently selected from the group consisting of straight beams and curved beams; and,

expanding the scaffolding in the subject in operable connection with a stabilizer that slidably engages with the support beams and provides an opposing force to each beam in the plurality of support beams during the expanding, the opposing force retaining each beam in the plurality of support beams from a lateral movement that exceeds the expanded state.

2. The method of claim 1 , further comprising:

selecting the intervertebral scaffolding to include an assembly of 4 independently operable, structural beams in an at least substantially parallel orientation for an expansion of the assembly from a collapsed state to an expanded state;

wherein, the assembly includes a first top beam, a second top beam, a first bottom beam, and a second bottom beam, each beam having a central axis and designed to bear the compression load in the cephalocaudal direction in a subject, the compression load applied at least substantially normal to the central axis of each beam in an intervertebral space of the subject.

3. The method of claim 2 , further comprising:

selecting the stabilizer to include an X-configuration having a first top leg for slidably-engaging with the first top beam at an angle θ ir with the lateral movement of the first top beam, first bottom leg for slidably engaging with the first bottom beam at an angle θ 1B with the lateral movement of the first bottom beam, a second top leg for slidably engaging with the second top beam at an angle θ 2T with the lateral movement of the second top beam, and a second bottom leg for slidably engaging with the second bottom beam at an angle θ 2B with the lateral movement of the second bottom beam;

wherein, each of the angles θ 1T , θ 1B , θ 2T , θ 2B , respectively, provides a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state.

4. The method of claim 2 , further comprising:

selecting the stabilizer with an X-configuration having a first top leg for slidably-engaging with the first top beam at an angle θ ir with the lateral movement of the first top beam, first bottom leg for slidably engaging with the first bottom beam at an angle θ 1B with the lateral movement of the first bottom beam, a second top leg for slidably engaging with the second top beam at an angle θ 2T with the lateral movement of the second top beam, and a second bottom leg for slidably engaging with the second bottom beam at an angle θ 2B with the lateral movement of the second bottom beam, wherein each of the angles θ 1T , θ 1B , θ 2T , θ 2B , respectively, provides a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state; and,

obtaining a rigid expansion member for expansion of the beams and retention by the stabilizer.

5. The method of claim 2 , wherein the obtaining further comprises selecting the stabilizer with

a first top leg for slidably-engaging with the first top beam at an angle θ ir with the lateral movement of the first top beam;

a first bottom leg for slidably engaging with the first bottom beam at an angle θ 1B with the lateral movement of the first bottom beam;

a second top leg for slidably engaging with the second top beam at an angle θ 2T with the lateral movement of the second top beam; and,

a second bottom leg for slidably engaging with the second bottom beam at an angle θ 2 B with the lateral movement of the second bottom beam;

wherein each of the angles θ 1T , θ 1B , θ 2T , θ 2B , respectively, is >O and provides a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state.

6. The method of claim 2 , wherein the obtaining further comprises selecting the stabilizer with a first vertical leg, a second vertical leg, and a cross-member that connects the first vertical leg to the second vertical leg, the first vertical leg including a retaining surface for engaging with the first top beam and the first bottom beam, the second vertical leg including a retaining surface for engaging with the second top beam and the second bottom beam, and the cross member providing a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state.

7. The method of claim 2 , wherein the obtaining further comprises selecting the stabilizer with a first vertical leg, a second vertical leg, and a cross-member that connects the first vertical leg to the second vertical leg, the first vertical leg including a retaining surface for engaging with the first top beam and the first bottom beam, the second vertical leg including a retaining surface for engaging with the second top beam and the second bottom beam, and the cross member providing a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state; and,

obtaining a rigid expansion member for expansion of the beams and retention by the stabilizer.

8. The method of claim 2 , further comprising:

selecting the stabilizer to have

a first vertical leg, a second vertical leg, a cross-member that connects the first vertical leg at least substantially parallel to the second vertical leg, the first vertical leg including a retaining surface for engaging with the first top beam and the first bottom beam, the second vertical leg including a retaining surface for engaging with the second top beam and the second bottom beam, and the cross member providing a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from the lateral movement that exceeds the expanded state; and,

a point of attachment for releasably attaching a guidewire adapted for guiding an expansion member into the laterally expandable scaffolding.

9. The method of claim 2 , further comprising:

selecting the stabilizer to have an H-configuration having a first vertical leg, a second vertical leg, a cross-member that connects the first vertical leg at least substantially parallel to the second vertical leg, the first vertical leg including a retaining surface for engaging with the first top beam and the first bottom beam, the second vertical leg including a retaining surface for engaging with the second top beam and the second bottom beam, and the cross member providing a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from the lateral movement that exceeds the expanded state.

10. The method of claim 2 , further comprising

adding a top connector element that is configured to expandably connect the first top beam to the second top beam to form a top plane; and,

adding a bottom connector element that is configured to expandably connect the first bottom beam to the second bottom beam to form a bottom plane;

wherein, the top connector element and the bottom connector each operate independently of the stabilizer.

11. The method of claim 2 , further comprising

adding a first side connector element configured to expandably connect the first top beam to the first bottom beam; and,

adding a second side connector element configured to expandably connect the second top beam to the second bottom beam;

wherein, the top connector element is configured monolithically integral to the first top beam and the second top beam; the bottom connector element is configured monolithically integral to the first bottom beam and the second bottom beam; the first side connector element is configured monolithically integral to the first top beam and the second top beam; the second side connector element is configured monolithically integral to the first bottom beam and the second bottom beam;

wherein, the top connector element, the bottom connector element, the first side connector element, and the second side connector element each operate independently of the stabilizer.

12. The method of claim 1 further comprising obtaining a rigid expansion member having a grafting port.

13. A method of fusing an intervertebral space with a stabilized intervertebral scaffolding, the method comprising:

obtaining a laterally expandable intervertebral scaffolding having a collapsed state, an expanded state, and a plurality of support beams, each beam in the plurality of beams designed to bear a compression load in the cephalocaudal direction in a subject;

creating a point of entry into an intervertebral disc, the intervertebral disc having a nucleus pulposus surrounded by an annulus fibrosis;

removing the nucleus pulposus from within the intervertebral disc through the point of entry, leaving the intervertebral space for expansion of the scaffolding within the annulus fibrosis, the intervertebral space having a top vertebral plate and a bottom vertebral plate;

inserting the laterally expandable intervertebral scaffolding in the collapsed state through the point of entry into the intervertebral space;

expanding the scaffolding in the presence of a stabilizer providing an opposing lateral force to a respective support beam during the expansion of the assembly, the opposing lateral force retaining the respective support beam from the lateral movement that exceeds the expanded state in the subject; and,

adding a grafting material to the intervertebral space.

14. The method of claim 13 ,

wherein the creating of the point of entry comprises creating a lateral dimension of the point of entry ranging from about 5 mm to about 15 mm, and the amount of lateral expansion is selected to exceed the lateral dimension of the point of entry.

15. The method of claim 13 , wherein the expanding includes:

expanding the laterally expandable intervertebral scaffolding laterally to a width that exceeds the width of the point of entry.

16. The method of claim 13 , wherein the expanding of the laterally expandable intervertebral scaffolding includes

inserting an expansion member that is sized to expand the scaffolding laterally within the stabilizer for the retaining; and,

engaging a means for preventing the expansion member from backing out of the laterally expandable intervertebral scaffolding after the expanding.

17. A kit, comprising:

a laterally expandable intervertebral scaffolding having a collapsed state, an expanded state, and a plurality of support beams, each beam in the plurality of support beams designed to bear a compression load in the cephalocaudal direction in a subject;

a stabilizer providing an opposing lateral force to a respective support beam during the expansion of the scaffolding, the opposing lateral force retaining the respective support beam from a lateral movement that exceeds the expanded state; and,

a guidewire adapted for guiding an expansion member into the laterally expandable scaffolding;

wherein:

the laterally expandable scaffolding has 4 independently operable beams in an at least substantially parallel orientation, the beams including a first top beam, a second top beam, a first bottom beam, and a second bottom beam; and,

the stabilizer has an X-configuration with a first top leg for slidably-engaging with the first top beam at an angle θ 1T with the lateral movement of the first top beam, first bottom leg for slidably engaging with the first bottom beam at an angle θ 1B with the lateral movement of the first bottom beam, a second top leg for slidably engaging with the second top beam at an angle θ 2T with the lateral movement of the second top beam, and a second bottom leg for slidably engaging with the second bottom beam at an angle θ 2B with the lateral movement of the second bottom beam, wherein each of the angles θ 1T , θ 1B , θ 2T , θ 2B , respectively, provides a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state.

18. The kit of claim 17 , wherein:

the laterally expanding scaffolding has 4 independently operable beams in an at least substantially parallel orientation, the beams including a first top beam, a second top beam, a first bottom beam, and a second bottom beam; and,

the stabilizer has

a first top leg for slidably-engaging with the first top beam at an angle OIT with the lateral movement of the first top beam;

a first bottom leg for slidably engaging with the first bottom beam at an angle θ 1B with the lateral movement of the first bottom beam;

a second top leg for slidably engaging with the second top beam at an angle θ 2T with the lateral movement of the second top beam; and,

a second bottom leg for slidably engaging with the second bottom beam at an angle θ 2 B with the lateral movement of the second bottom beam;

wherein each of the angles θ 1T , θ 1B , θ 2T , θ 2B , respectively, is >0 and provides a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state.

19. The kit of claim 17 , wherein:

the laterally expandable scaffolding has 4 independently operable beams in an at least substantially parallel orientation, the beams including a first top beam, a second top beam, a first bottom beam, and a second bottom beam; and,

the stabilizer has

a first vertical leg, a second vertical leg, and a cross-member that connects the first vertical leg to the second vertical leg, the first vertical leg including a retaining surface for engaging with the first top beam and the first bottom beam, the second vertical leg including a retaining surface for engaging with the second top beam and the second bottom beam, and the cross member providing a tensile force for resisting the first top beam, the first bottom beam, the second top beam, and the second bottom beam from a lateral movement that exceeds the expanded state.

Assignments (4)
GRANT OF A SECURITY INTEREST -- PATENTS Recorded Sep 18, 2025
From: HIGHRIDGE MEDICAL, LLC (F/K/A ZIMMER BIOMET SPINE, LLC)
To: CERBERUS BUSINESS FINANCE AGENCY, LLC, AS COLLATERAL AGENT
Reel/Frame 072942/0175 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 17, 2025
From: INTEGRITY IMPLANTS INC.
To: HIGHRIDGE MEDICAL LLC
Reel/Frame 072281/0955 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 19, 2025
From: OUROBOROS MEDICAL, INC.
To: INTEGRITY IMPLANTS INC.
Reel/Frame 069926/0097 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2025
From: TO, JOHN; FLYNN, JOHN J
To: OUROBOROS MEDICAL, INC.
Reel/Frame 069926/0086 →
Continuity (6)
Continuation 16932064 · Jul 17, 2020
Continuation 15979873 · May 15, 2018
Continuation 15194463 · Jun 27, 2016
Continuation 14701013 · Apr 30, 2015
Continuation 14600617 · Jan 20, 2015
Related Publication 20240299185A1 · Sep 12, 2024
References Cited (2)
US 11918484B2 · To · 2024 [cited by examiner]
US 20140094916A1 · Glerum · 2014 [cited by examiner]