# US 11,076,968 B2 · Expandable scaffolding with a rigid, central beam

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- Number: US 11,076,968 B2
- Document ID: US11076968B2
- Status: Granted
- Kind: B2
- Application number: 16/527,294
- Filed: 2019-07-31
- Published: 2020-02-13
- Granted: 2021-08-03
- Earliest claimed: 2012-12-13
- Assignees: Integrity Implants Inc.
- Applicants: Integrity Implants Inc.
- Inventors: John To; John J. Flynn; Paul J. Birkmeyer
- Web page: https://patentgrep.com/patent/US11076968B2

## CPC

- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- 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)}
- A61F 2/4611: {of spinal prostheses}
- A61F 2/30965: {Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping}
- A61F 2/441: {made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel}
- A61F 2/4684: {Trial or dummy prostheses}
- A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61F 2002/30019: {differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability}
- A61F 2002/30556: {for adjusting thickness}
- A61F 2002/30579: {with mechanically expandable devices, e.g. fixation devices}
- A61F 2002/30581: {having a pocket filled with fluid, e.g. liquid}
- A61F 2002/30593: {hollow}
- A61F 2002/30594: {slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots}
- A61F 2002/30777: {Oblong apertures}
- A61F 2002/30779: {arcuate}
- A61F 2002/30785: {parallel}
- A61F 2002/4435: {Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes}
- A61F 2002/444: {for replacing the nucleus pulposus}
- A61F 2310/00011: Metals or alloys
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00029: Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
- A61F 2310/00047: Aluminium or Al-based alloys
- A61F 2310/00053: Vanadium or V-based alloys
- A61F 2310/00071: Nickel or Ni-based alloys
- A61F 2310/00179: Ceramics or ceramic-like structures
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

An intervertebral scaffolding system is provided having a rigid central beam and a laterovertically-expanding frame operable for a reversible collapse from an expanded state into a collapsed state.

## Claims

### Claim 1

An intervertebral scaffolding system for use in a subject, comprising;
a central beam having a proximal portion and a distal portion, wherein the central beam is sized to have a transverse cross-section having a maximum dimension ranging from 5 mm to 15 mm for placing the central beam into an intervertebral space through an annular opening having a maximum lateral dimension ranging from 5 mm to 15 mm; and,
an expanding frame having a collapsed state and an expanded state, the frame configured for operably contacting the central beam to create an intervertebral scaffolding system in vivo, the frame having
a proximal end and a distal end; and,
a lumen formed by the expanding frame, the lumen of the frame configured for slidably engaging with the central beam in vivo following placement of the central beam in the intervertebral space through the annular opening, the slidably engaging including translating the central beam into the frame from the proximal end of the frame toward the distal end of the frame in vivo.

### Claim 2 (depends on 1)

The scaffolding system of claim 1, wherein the scaffolding has a localized loading range from about 1.0× to about 2.0× the vertebral body compression strength of the subject.

### Claim 3 (depends on 1)

The scaffolding system of claim 1, wherein the scaffolding has a top surface that supports a top vertebral endplate, a bottom surface that supports a bottom vertebral endplate, and the top surface and the bottom surface remain at least substantially constant in length regardless of the amount of expansion.

### Claim 4 (depends on 1)

The scaffolding system of claim 1, the central beam comprising an I-beam.

### Claim 5 (depends on 1)

The scaffolding system of claim 1, the central beam further comprising a grafting port.

### Claim 6 (depends on 1)

The scaffolding system of claim 1, wherein the scaffolding comprises a plurality of beams interconnected by a plurality of struts configured in an at least substantially parallel alignment in the collapsed state.

### Claim 7 (depends on 1)

The scaffolding system of claim 1, wherein the struts are configured monolithically integral to the top beam and the bottom beam.

### Claim 8 (depends on 1)

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 expanding frame in the collapsed state through the point of entry into the intervertebral space;
inserting the central beam into the frame to form the scaffolding system;
and,
adding a grafting material to the intervertebral space.

### Claim 9 (depends on 8)

The method of claim 8, wherein the connector elements are struts are adapted to stack in the collapsed state to minimize void space for a low profile entry of the frame into the intervertebral space.

### Claim 10 (depends on 8)

The method of claim 8, wherein the expanding includes
expanding the expanding frame laterally to a width that exceeds the width of the point of entry; and,
inserting the central beam to expand the expanding frame vertically to support the frame in the expanded state.

### Claim 11 (depends on 1)

A kit, comprising:
the scaffolding system of claim 1;
a cannula for inserting the scaffolding system into the intervertebral space;
a guidewire adapted for guiding the central beam into the expanding frame; and,
an expansion handle for inserting the central beam into the expanding frame to form the scaffolding system.

### Claim 12 (depends on 11)

The kit of claim 11, the distal end of the frame having a slidably translational connection with a guide that restricts the expandable frame to movement relative to the guide when converting the frame from the collapsed state to the expanded state in vivo.

### Claim 13 (depends on 11)

The kit of claim 11; wherein, the expandable frame has a plurality of beams interconnected by struts, and the struts are configured monolithically integral to the plurality of beams.

### Claim 14

An intervertebral scaffolding system, comprising:
a plurality of beams that define an expandable frame comprising a collapsed state and an expanded state, the plurality of beams configured at least substantially parallel in the collapsed state and define a proximal-distal axis, and a plurality of connector elements that operably connect the plurality of beams and maintain a high structural stiffness and strength in the direction perpendicular to the proximal-distal axis so that a transverse cross section perpendicular to the proximal-distal axis maintains shape during and after insertion of the frame into the intervertebral disc space,
a lumen surrounded by the plurality of beams;
a central beam configured for translatably inserting into the lumen to expand the expandable frame.

### Claim 15 (depends on 14)

The scaffolding system of claim 14, wherein the plurality of connector elements are configured monolithically integral to the plurality of beams.

### Claim 16 (depends on 14)

The scaffolding system of claim 14, wherein, the connector elements are struts configured monolithically integral to the plurality of beams.

### Claim 17 (depends on 14)

The scaffolding system of claim 14, the distal end of the frame having a guide that restricts the movement of the plurality of beams when converting the frame from the collapsed state to the expanded state in vivo.

### Claim 18 (depends on 14)

The scaffolding system of claim 14, the central beam further comprising a graft port.

### Claim 19 (depends on 14)

The scaffolding system of claim 14, wherein
the plurality of beams include a first top beam, a first bottom beam, a second top beam, and a second bottom beam; wherein, the first top beam and the first bottom beam form an angle ⊖FS, the second top beam and the second bottom beam form an angle ⊖SS, and each of ⊖FSand ⊖SS are independently selected as something other than 0°, such that (i) the first top beam and the first bottom beam or (ii) the second top beam and the second bottom beam, are not substantially parallel in the expanded state; ⊖FSand ⊖SS are each independently selected to range from about 0.5° to 31.5°.

### Claim 20 (depends on 19)

The scaffolding system of claim 19, wherein ⊖FS and ⊖SS are each independently selected to be about 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, 15°, 16°, 17°, 18°, 19°, 20°, 21°, 22°, 23°, 24°, 25°, 26°, 27°, 28°, 29°, 30°, 31°, 32°, 33°, 34°, 35°, or any angle therein in increments of 0.1°.