# US 9,486,323 B1 · Nuclear implant apparatus and method following partial nuclectomy

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- Number: US 9,486,323 B1
- Document ID: US9486323B1
- Status: Granted
- Kind: B1
- Application number: 14/934,987
- Filed: 2015-11-06
- Granted: 2016-11-08
- Earliest claimed: 2015-11-06
- Assignees: Spinal Stabilization Technologies LLC
- Applicants: Spinal Stabilization Technologies LLC
- Inventors: Nadi S. Hibri; W. Loren Francis; Mark A. Novotny
- Web page: https://patentgrep.com/patent/US9486323B1

## CPC

- A61F 2/441: {made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel}
- 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 2/30749: {Fixation appliances for connecting prostheses to the body}
- A61F 2002/30069: {elastomeric}
- A61F 2002/30505: {spring biased}
- A61F 2002/30576: {with extending fixation tabs}
- A61F 2002/30579: {with mechanically expandable devices, e.g. fixation devices}
- A61F 2002/30583: {filled with hardenable fluid, e.g. curable in-situ}
- A61F 2002/30586: {having two or more inflatable pockets or chambers}
- A61F 2002/30971: {Laminates, i.e. layered products}
- 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 2002/4615: {of spacers}
- 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 expandable implant for augmenting a damaged or otherwise torn posterior annulus fibrosus. The implant is deployable into an evacuated posterior disc space following a subtotal nuclectomy. The implant includes an inflatable balloon which is fixed to the annulus fibrosus to protect against migration. When inflated with a curable polymer, the posterior wall of the implant is intimately disposed along the inner surface of the annulus fibrosus to provide a substantially fluid-tight seal of the annular tear or defect and reinforce the weakened posterior annulus. The anterior wall of the implant sequesters the nuclear remnant to guard against disc remnant herniation. The implant can restore intradiscal pressure and disc height. An integrated posterior reinforcement band creates a strong, yet flexible and resilient structure, resistant to penetration of the implant through the annular tear or defect.

## Claims

### Claim 1

An apparatus for reinforcing a damaged annulus fibrosus, comprising:
an inflatable balloon having a first end, a second end, a posterior portion which is adapted to seal against an annulus fibrosus, and an anterior portion which is more compliant than the posterior portion;
a first anchor coupled to the first end of the inflatable balloon, the first anchor being adapted to anchor the first end of the inflatable balloon to a first location of the annulus fibrosus at a first lateral side of the annulus fibrosus; and
a second anchor coupled to the second end of the inflatable balloon, the second anchor being adapted to anchor the second end of the inflatable balloon to a second lateral side of the annulus fibrosus.

### Claim 2 (depends on 1)

The apparatus of claim 1, further comprising a reinforcing layer coupled to the posterior portion of the balloon.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein
the posterior portion of the balloon further comprises a reinforcing layer coupled to a posterior side of the balloon so that the posterior portion is substantially non-compliant; and
the anterior portion of the balloon comprises a silicone material so that the anterior portion is substantially compliant.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the inflatable balloon comprises silicone.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the inflatable balloon comprises PTFE.

### Claim 6 (depends on 5)

The apparatus of claim 5, further comprising a carbon layer disposed on an inner surface of the inflatable balloon.

### Claim 7 (depends on 5)

The apparatus of claim 5, wherein the PTFE balloon is porous.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the first anchor further comprises at least one inflation port for injecting an inflation material into the inflatable balloon.

### Claim 9 (depends on 8)

The apparatus of claim 8, wherein the second anchor further comprises at least one inflation port for injecting an inflation material into the inflatable balloon.

### Claim 10 (depends on 1)

The apparatus of claim 1, further comprising a curable material in the inflatable balloon.

### Claim 11 (depends on 1)

The apparatus of claim 1, wherein the posterior portion comprises multiple layers.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein an outer layer in the posterior portion comprises an opening for allowing an inner layer of the posterior portion to protrude therethrough upon inflation.

### Claim 13 (depends on 1)

The apparatus of claim 1, wherein the inflatable balloon comprises an electrospun polymeric material.

### Claim 14 (depends on 1)

The apparatus of claim 1, wherein the first anchor comprises an expanded portion for helping to prevent the first anchor from being pulled through the annulus fibrosus.

### Claim 15 (depends on 1)

The apparatus of claim 1, wherein the second anchor comprises a retaining member with an expanded portion for helping to prevent the second anchor from being pulled through the annulus fibrosus.

### Claim 16 (depends on 1)

The apparatus of claim 1, wherein the inflatable balloon comprises multiple layers adapted to provide different properties to the inflatable balloon.

### Claim 17 (depends on 1)

The apparatus of claim 1, wherein the second anchor comprises first and second loops of material extending from the second anchor.

### Claim 18 (depends on 17)

The apparatus of claim 17, further comprising a retaining member for engaging one of the first and second loops of material.