IP Library Granted Patent US 11,717,415
Granted Patent B2
US 11,717,415 · App. 17/085,788 · Granted Aug 8, 2023

Scaffolding with locking expansion member

Inventors: John To (Newark, CA); John J. Flynn (Walnut Creek, CA); John Souza (Monroe, NC); Andrew Wolf (Jupiter, FL)
Assignee: Integrity Implants Inc.
A61F2/4455A61F2/442A61F2/446A61F2/447A61F2/4465A61F2/4611A61F2002/30515A61F2002/30556A61F2002/30579A61F2002/30593A61F2002/4627
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Quick Facts
Patent No.
US 11,717,415
App. No.
17/085,788
Granted
Aug 8, 2023
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, one or more tensioners, or a combination of the stabilizer with one or more tensioners. The stabilizer slidably engages with the distal region of the laterovertically-expanding frame and both the stabilizer and the one or more tensioners are configured for retaining the laterovertically-expanding frame from a lateral movement that exceeds the expanded state, and the stabilizer can include a locking element that engages with the expansion member to lock the expansion member to the stabilizer when the expansion member is fully inserted into the frame. 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 (40)

1. An intervertebral scaffolding system, comprising:

an expandable frame dimensioned to be inserted into an intervertebral space of a mammalian spine and configured to expand in vivo between a collapsed state and an expanded state, the frame comprising a first top beam, a first bottom beam, a second top beam, a second bottom beam;

a stabilizer configured for retaining the first top beam, the first bottom beam, the second top beam, or the second bottom beam from a lateral movement that exceeds the expanded state, the stabilizer having first and second retaining surfaces positioned opposite and facing one another such that the first retaining surface is configured to engage with the first top beam and the first bottom beam, and the second retaining surface is configured to engage with the second top beam and the second bottom beam, the stabilizer further including a locking element; and

an expansion member configured for in vivo introduction into the expandable frame to cause the expandable frame to transition from the collapsed state to the expanded state within the intervertebral space, the expansion member configured to engage the locking element, the expansion member having a first portion and a second portion that are displaceable relative to one another for engaging with the locking element.

2. The intervertebral scaffolding system of claim 1 , wherein a displacing of the first portion and second portion relative to one another disengages the expansion member from the locking element.

3. The intervertebral scaffolding system of claim 1 , further comprising one or more tensioners for stabilizing and/or retaining at least one of the first top beam, first bottom beam, second top beam, and second bottom beam upon expansion of the expandable frame in the intervertebral disc space.

4. The intervertebral scaffolding system of claim 3 , wherein the stabilizer is in an H-configuration having a first vertical leg, a second vertical leg, a cross-member that connects the first vertical leg to the second vertical leg, the first vertical leg including the first retaining surface for engaging with the first top beam and the first bottom beam, the second vertical leg including the second 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.

5. The intervertebral scaffolding system of claim 1 , wherein the stabilizer is in an H-configuration having a first vertical leg, a second vertical leg, a cross-member that connects the first vertical leg to the second vertical leg, the first vertical leg including the first retaining surface for engaging with the first top beam and the first bottom beam, the second vertical leg including the second 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.

6. The intervertebral scaffolding system of claim 1 , wherein the expansion member includes a port for introducing bone graft material into the intervertebral space.

7. A kit, comprising:

the scaffolding system of claim 3 , and;

an insertion tool for inserting the scaffolding system into the intervertebral space.

8. A kit, comprising:

the scaffolding system of claim 1 ; and,

an insertion tool for inserting the scaffolding system into the intervertebral space.

9. A shim removal tool for engaging the scaffolding system of claim 1 , comprising:

a shaft with a lumen; and,

prongs for displacing the first portion and second portion of the expansion member relative to one another to disengage the expansion member from the locking element;

wherein the prongs are sized and shaped for entry through the lumen of the shaft and into the expansion member.

10. A method of fusing an intervertebral space using the intervertebral scaffolding system of claim 1 , the method comprising:

creating a point of entry having a lateral dimension 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 system of claim 1 within the annulus fibrosis, the intervertebral space having a top vertebral plate and a bottom vertebral plate;

inserting the expandable frame in a collapsed state through the point of entry into the intervertebral space;

expanding the expandable frame within the intervertebral space; and,

adding a bone grafting material to the intervertebral space.

11. The method of claim 10 , wherein the lateral dimension of the point of entry ranges from 5 mm to 15 mm, and an amount of lateral expansion of the scaffolding system is selected to exceed the lateral dimension of the point of entry.

12. The method of claim 10 , wherein expanding includes the expandable frame comprises:

expanding the expandable frame laterally to a width that exceeds the lateral dimension of the point of entry; and,

expanding the expandable frame vertically to support the intervertebral space in the expanded state.

13. The method claim 10 , wherein adding the bone grafting material to the intervertebral space comprises injecting the bone grafting material through a port in the expansion member.

14. An intervertebral scaffolding system comprising:

an expandable frame dimensioned to be inserted into an intervertebral space of a mammalian spine and configured to expand in vivo between a collapsed state and an expanded state, the frame comprising a first top beam, a first bottom beam, a second top beam, a second bottom beam;

a stabilizer configured for retaining the first top beam, the first bottom beam, the second top beam, or the second bottom beam from a lateral movement that exceeds the expanded state, the stabilizer further including a locking element;

one or more tensioners for stabilizing and/or retaining at least one of the first top beam, first bottom beam, second top beam, and second bottom beam upon expansion of the expandable frame in the intervertebral disc space; and

an expansion member configured for in vivo introduction into the expandable frame to cause the expandable frame to transition from the collapsed state to the expanded state within the intervertebral space, the expansion member configured to engage the locking element, the expansion member having a first portion and a second portion that are displaceable relative to one another for engaging with the locking element;

wherein the stabilizer is in an X-configuration having a first top leg for slidably-engaging with the first top beam at an angle θ 1T with a 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 a 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 a 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 a lateral movement of the second bottom beam, wherein each of the angles θ 1T , θ 1B , θ 2T , θ 2B , respectively, provide 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.

15. The intervertebral scaffolding system of claim 14 , wherein a displacing of the first portion and second portion relative to one another disengages the expansion member from the locking element.

16. A kit, comprising:

the scaffolding system of claim 14 , and;

an insertion tool for inserting the scaffolding system into the intervertebral space.

Assignments (8)
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 →
RELEASE OF SECURITY INTEREST Recorded Sep 12, 2025
From: SYMBIOTIC CAPITAL AGENCY LLC
To: INTEGRITY IMPLANTS INC.
Reel/Frame 072879/0290 →
RELEASE OF SECURITY INTEREST IN PATENT Recorded Aug 28, 2025
From: SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT
To: INTEGRITY IMPLANTS INC.
Reel/Frame 072709/0756 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 21, 2025
From: TO, JOHN; FLYNN, JOHN J.; SOUZA, JOHN; WOLF, ANDREW
To: INTEGRITY IMPLANTS INC.
Reel/Frame 069935/0256 →
PATENT SECURITY AGREEMENT Recorded Dec 21, 2023
From: INTEGRITY IMPLANTS INC.
To: SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 066090/0832 →
RELEASE OF SECURITY INTEREST Recorded Nov 10, 2023
From: EASTWARD FUND MANAGEMENT, LLC
To: INTEGRITY IMPLANTS INC.
Reel/Frame 065536/0632 →
SECURITY INTEREST Recorded Jun 18, 2021
From: INTEGRITY IMPLANTS INC.
To: EASTWARD FUND MANAGEMENT, LLC
Reel/Frame 057079/0965 →
Continuity (3)
Continuation 16334486
Continuation 15271741 · Sep 21, 2016
Related Publication 20210045893A1 · Feb 18, 2021
Cited By (1)
US 12,491,080