# US 9,545,321 B2 · Prosthetic spinal disk nucleus

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- Number: US 9,545,321 B2
- Document ID: US9545321B2
- Status: Granted
- Kind: B2
- Application number: 14/536,497
- Filed: 2014-11-07
- Published: 2015-02-26
- Granted: 2017-01-17
- Earliest claimed: 2013-03-14
- Assignees: Spinal Stabilization Technologies LLC
- Applicants: Spinal Stabilization Technologies, LLC
- Inventors: Nadi Salah Hibri; James Douglas Lutz
- Web page: https://patentgrep.com/patent/US9545321B2

## CPC

- A61F 2/4611: {of spinal prostheses}
- A61F 2/44: for the spine, e.g. vertebrae or spinal discs
- A61B 17/1671: {for the spine}
- A61F 2002/30092: {using shape memory or superelastic materials, e.g. nitinol}
- A61F 2002/30235: {tubular, e.g. sleeves}
- A61F 2002/30448: {using adhesives}
- A61F 2002/30579: {with mechanically expandable devices, e.g. fixation devices}
- A61F 2002/30584: {filled with gas}
- A61F 2002/30586: {having two or more inflatable pockets or chambers}
- 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 2002/4627: {with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument}
- A61F 2002/4693: {hydraulic}
- A61F 2002/4694: {pneumatic}
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0069: Sealing means
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

This specification describes technologies relating to an intervertebral disc prosthesis used to strengthen and stabilize the spine. Implementations of the technology described herein comprise a surgical device that is implanted through a small surgical incision into a portion of a human intervertebral disc, various support tools used to insert such a surgical device, and a method by which the device is used to strengthen and stabilize the spine.

## Claims

### Claim 1

An implantable prosthetic device comprising:
an inner chamber;
an outer chamber fluidly isolated from the inner chamber; and
a sealing valve in fluid communication with the inner chamber and the outer chamber, the sealing valve comprising
a first sealing mechanism comprising a fill tube with a first aperture between an interior of the fill tube and an exterior of the fill tube, the fill tube being movable between an open position and a closed position,
a second sealing mechanism comprising a fill channel with a second aperture between an interior of the fill channel and an interior of the outer chamber, and a stopper element, the stopper element being slidable within the fill channel between an open position and a closed position, and
a biasing element for applying force to the stopper element to slide the stopper element into the closed position;
wherein when the sealing valve is in an open position, the first aperture of the first sealing mechanism is open to allow the inflow of a first material into the inner chamber and the stopper element is positioned so that the second aperture of the second sealing mechanism is open to allow fluid communication between the interior of the fill channel and the interior of the outer chamber to allow the inflow of a second material into the outer chamber;
wherein when the sealing valve is in a closed position, the first aperture of the first sealing mechanism is blocked to prevent outflow of the first material from within the inner chamber and the stopper element blocks the second aperture of the second sealing mechanism to prevent outflow of the second material from within the outer chamber;
wherein a force applied to the stopper element slides the stopper element into the open position to allow fluid communication between the interior of the fill channel and the interior of the outer chamber; and;
wherein the biasing element slides the stopper element toward the closed position to cause the sealing valve to enter the closed position when the force is released.

### Claim 2 (depends on 1)

The device of claim 1, wherein the first material comprises an inert gas.

### Claim 3 (depends on 1)

The device of claim 1, wherein the second material comprises a silicone polymer.

### Claim 4 (depends on 3)

The device of claim 3, wherein the silicone polymer is curable.

### Claim 5 (depends on 1)

The device of claim 1, wherein the second material comprises an imaging contrast agent.

### Claim 6 (depends on 1)

The device of claim 1, further comprising an inflation device, the inflation device comprising:
a first channel; and
a second channel fluidly isolated from the first channel;
wherein the inflation device is adapted to apply the force to the stopper element, position the first channel in fluid communication with the inner chamber, position the second channel in fluid communication with the outer chamber, and simultaneously transfer the first material from the first channel to inner chamber and transfer the second material from the second channel to the outer chamber.

### Claim 7 (depends on 1)

The device of claim 1, wherein the prosthetic device is collapsible.

### Claim 8 (depends on 1)

The device of claim 1, wherein inflating the inner chamber or the outer chamber with a material causes the prosthetic device to expand.

### Claim 9 (depends on 1)

The device of claim 1, further comprising a memory material, wherein the memory material expands the device to a pre-determined shape.

### Claim 10 (depends on 1)

The device of claim 1, wherein the device is adapted to fit into a surgical cannula.

### Claim 11 (depends on 1)

The device of claim 1, wherein the device is adapted for use as an intervertebral disc prosthesis.

### Claim 12 (depends on 11)

The device of claim 11, wherein the device is configured to be implanted to fit adjacent a first vertebra against an upper surface and a second vertebra against a lower surface, such that the first vertebra is separated from the second vertebra.

### Claim 13

A method of implanting a prosthetic device, comprising:
penetrating the annular fibrosus;
removing the nucleus pulposus;
implanting an inflatable device within the annular fibrosus, the inflatable device comprising:
an inner chamber;
an outer chamber fluidly isolated from the inner chamber; and
an inner chamber;
an outer chamber fluidly isolated from the inner chamber; and
a sealing valve in fluid communication with the inner chamber and the outer chamber, the sealing valve comprising
a first sealing mechanism comprising a fill tube with a first aperture between an interior of the fill tube and an exterior of the fill tube, the fill tube being movable between an open position and a closed position,
a second sealing mechanism comprising a fill channel with a second aperture between an interior of the fill channel and an interior of the outer chamber and a stopper element, the stopper element being slidable within the fill channel between an open position and a closed position, and
a biasing element for applying force to the stopper element to slide the stopper element into the closed position;
wherein when the sealing valve is in an open position, the first aperture of the first sealing mechanism is open to allow the inflow of a first material into the inner chamber and the stopper element is positioned so that the second aperture of the second sealing mechanism is open to allow fluid communication between the interior of the fill channel and the interior of the outer chamber to allow the inflow of a second material into the outer chamber;
wherein when the sealing valve is in a closed position, the first aperture of the first sealing mechanism is blocked to prevent outflow of the first material from within the inner chamber and the stopper element blocks the second aperture of the second sealing mechanism to prevent outflow of the second material from within the outer chamber;
wherein a force applied to the stopper element slides the stopper element into the open position to allow fluid communication between the interior of the fill channel and the interior of the outer chamber; and;
wherein the biasing element slides the stopper element toward the closed position to cause the sealing valve to enter the closed position when the force is released.

### Claim 14

An implantable prosthetic device comprising:
an inner chamber;
an outer chamber fluidly isolated from the inner chamber;
a first sealing mechanism comprising a fill tube with a first aperture between an interior of the fill tube and an exterior of the fill tube, the fill tube being movable between an open position wherein the first aperture is open to allow fluid communication between the interior of the fill tube and the inner chamber and a closed position wherein the first aperture is blocked to prevent fluid communication between the interior of the fill tube and the inner chamber; and
a second sealing mechanism comprising:
a fill channel with a second aperture between an interior of the fill channel and an interior of the outer chamber,
a stopper element slidably mounted in the fill channel to slide between an open position wherein the second aperture is open to allow fluid communication between the interior of the fill channel and the outer chamber and a closed position wherein the second aperture is blocked by the stopper element to prevent fluid communication between the interior of the fill channel and the outer chamber, and
a biasing element for applying force to the stopper element, wherein a force applied to the stopper element slides the stopper element into the open position and the biasing element urges the stopper element toward the closed position to cause the stopper element to enter the closed position when the force is released.

### Claim 15

An implantable prosthetic device comprising:
an inner chamber;
an outer chamber fluidly isolated from the inner chamber;
a fill channel with an aperture for selectively allowing fluid communication between an interior of the outer chamber and the fill channel;
a stopper element slidably mounted in the fill channel for movement between a closed position and an open position, wherein in the closed position the stopper element blocks the fill channel aperture to prevent fluid communication between the interior of the outer chamber and the fill channel, and in the open position the stopper element is displaced from the fill channel aperture to allow fluid communication between the interior of the outer chamber and the fill channel;
a biasing element for urging the stopper element into the closed position; and
a fill tube with an aperture for selectively allowing fluid communication between an interior of the inner chamber and the fill tube, wherein the fill tube is slidably mounted between a closed position and an open position, wherein in the closed position the fill tube aperture is blocked to prevent fluid communication between the interior of the inner chamber and the fill tube, and in the open position the fill tube aperture is open to allow fluid communication between the interior of the inner chamber and the fill tube.