Stabilized, laterovertically-expanding fusion cage systems

• US 9,402,733 B1
• Filed: 04/30/2015
• Issued: 08/02/2016
• Est. Priority Date: 01/20/2015
• Status: Active Grant

• Current Assignee: Integrity Implants, Inc.
• Original Assignee: Integrity Implants, Inc.
• Inventors: To, John, Flynn, John J.
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Negrellirodrigue, Christina
• Application Number:
  US14/701,013
• Publication Number:
  US 20160206439A1
• Time in Patent Office: 460 Days
• Field of Search: 606246-249, 623 1711- 1716
• US Class Current: 1/1
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30476 locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/4677 using a guide wire

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

1. An intervertebral scaffolding system, comprising;

a laterovertically-expanding frame configured to create an intervertebral scaffolding system in vivo, the frame having

a collapsed state and an expanded state, the expanded state operably contacting the intervertebral space;

a proximal portion having an end, a distal portion having an end, and a central frame axis of the expanded state;

a first top beam including a proximal portion having an end and a distal portion having an end, the central axis of the first top beam at least substantially on (i) a top plane containing the central axis of the first top beam and a central axis of a second top beam and (ii) a first side plane containing the central axis of the first top beam and a central axis of a first bottom beam;

the second top beam including a proximal portion having an end and a distal portion having an end, the central axis of the second top beam at least substantially on (i) the top plane and (ii) a second side plane containing the central axis of the second top beam and a central axis of a second bottom beam;

the first bottom beam including a proximal portion having an end and a distal portion having an end, the central axis of the first bottom beam at least substantially on (i) a bottom plane containing the central axis of the first bottom beam and the central axis of the second top beam and (ii) the first side plane;

the second bottom beam including a proximal portion having an end and a distal region having an end, the central axis of the second bottom beam being at least substantially on (i) the bottom plane and (ii) a second side plane containing the central axis of the second bottom beam and the central axis of the second top beam;

a plurality of top connector elements configured to expandably connect the first top beam to the second top beam, the expanding consisting of a flexing at least substantially on the top plane;

a plurality of bottom connector elements configured to expandably connect the first bottom beam to the second bottom beam, the expanding consisting of a flexing at least substantially on the bottom plane;

a plurality of first side connector elements configured to expandably connect the first top beam to the first bottom beam, the expanding consisting of a flexing at least substantially on the first side plane;

a plurality of second side connector elements configured to expandably connect the second top beam to the second bottom beam, the expanding consisting of a flexing at least substantially on the second side plane;

and,

a stabilizer that slidably engages with the distal region of the first top beam, the first bottom beam, the second top beam, the second bottom beam, or a combination thereof, and is configured for retaining the first top beam, the first bottom beam, the second top beam, the second bottom beam, or the combination thereof, from a lateral movement that exceeds the expanded state;

wherein,

the connector elements are configured to maintain structural stiffness in the laterovertically-expanding frame.

2. The scaffolding system of claim 1, 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 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, 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.

3. The scaffolding system of claim 1, 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 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, 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;

wherein, the system further comprises an expansion member, and the stabilizer further comprises a point of attachment for releasably attaching a guidewire for guiding the expansion member into the laterovertically expanding frame.

4. The scaffolding system of claim 1, 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 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, 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;

wherein, the system further comprises an expansion member, and the first top leg, the first bottom leg, the second top leg, and the second bottom leg converge to form a hub having a point of attachment for releasably attaching a guidewire for guiding the expansion member into the laterovertically expanding frame.

5. The scaffolding system of claim 1, wherein the stabilizer is in an H-configuration having a first vertical leg, a second vertical leg, and 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.

6. The scaffolding system of claim 1, wherein the stabilizer is in an H-configuration having a first vertical leg, a second vertical leg, and 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;

wherein, the system further comprises an expansion member with a horizontal groove configured complementary to the cross-member of the stabilizer, and the horizontal groove of the expansion member slidably connects with the cross-member in the expanded state.

7. The 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 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;

wherein, the system further comprises an expansion member, and the cross-member further comprises a vertical support member, the expansion member having a vertical groove configured complementary to the vertical support member of the stabilizer, and the vertical groove of the expansion member slidably connects with the vertical support member in the expanded state.

8. The 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 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;

wherein, the system further comprises an expansion member, and the stabilizer further comprises a point of attachment for releasably attaching a guidewire adapted for guiding the expansion member into the laterovertically expanding frame.

9. The 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 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;

wherein, the system further comprises an expansion member, and the cross-member includes a first pillar and a second pillar that operably connect at a hub that has a point of attachment for releasably attaching a guidewire for guiding the expansion member into the laterovertically expanding frame.

10. The scaffolding system of claim 1 further comprising a grafting port.

11. The scaffolding system of claim 1, wherein each plurality connector elements are struts;

and, wherein,

the top struts are configured monolithically integral to the first top beam and the second top beam; and

,

the bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam;

wherein, the top struts and bottom struts of the laterovertically-expanding frame are each configured to open a graft distribution window upon expansion, expanding from the first top beam to the second top beam, the first top beam to the first bottom beam, the second top beam to the second bottom beam, or the first bottom beam to the second bottom beam.

12. The scaffolding system of claim 1, wherein,

the top connector struts are configured monolithically integral to the first top beam and the second top beam;

and,

the bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam;

the first side struts are configured monolithically integral to the first top beam and the first bottom beam; and

,

the second side struts are configured monolithically integral to the second top beam and the second bottom beam;

wherein, the top, bottom, first side, and second side of the laterovertically-expanding frame form a monolithically integral frame.

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

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 system of claim 1 within the annulus fibrosis, the intervertebral space having a top vertebral plate and a bottom vertebral plate;

inserting the laterovertically expanding frame in the collapsed state through the point of entry into the intervertebral space;

expanding the laterovertically expanding frame to form the scaffolding system;

and,

adding a grafting material to the intervertebral space.

14. The method of claim 13, wherein the creating 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 laterovertically expanding frame laterally to a width that exceeds the width of the point of entry;

and,

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

16. The method of claim 13, wherein the expanding the laterovertically expanding frame includes inserting an expansion member and engaging a means for preventing the expansion member from backing out of the laterovertically-expanding frame after the expanding.

17. A kit, comprising:

the scaffolding system of claim 1;

a cannula for inserting the scaffolding system into the intervertebral space; and

,

a guidewire adapted for guiding an expansion member into the laterovertically expanding frame.

18. A kit, comprising:

the scaffolding system of claim 2;

a cannula for inserting the scaffolding system into the intervertebral space; and

,

a guidewire adapted for guiding an expansion member into the laterovertically expanding frame.

19. A kit, comprising:

the scaffolding system of claim 4;

a cannula for inserting the scaffolding system into the intervertebral space; and

,

a guidewire adapted for guiding the expansion member into the laterovertically expanding frame.

20. A kit, comprising:

the scaffolding system of claim 6;

a cannula for inserting the scaffolding system into the intervertebral space; and

,

a guidewire adapted for guiding the expansion member into the laterovertically expanding frame.