# US 11,744,710 B2 · Implantable nuclear prosthesis, kits, and related methods

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- Number: US 11,744,710 B2
- Document ID: US11744710B2
- Status: Granted
- Kind: B2
- Application number: 16/560,684
- Filed: 2019-09-04
- Published: 2020-04-16
- Granted: 2023-09-05
- Earliest claimed: 2018-09-04
- Assignees: Spinal Stabilization Technologies LLC
- Applicants: Spinal Stabilization Technologies, LLC
- Inventors: W. Loren Francis; Mark A. Novotny; Cory R. A. Hallam; Jake Ganem
- Web page: https://patentgrep.com/patent/US11744710B2

## CPC

- A61B 17/8855: {inflatable, e.g. kyphoplasty balloons}
- A61F 2/441: {made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel}
- A61B 17/8825: {characterised by syringe details (A61B17/8822, A61B17/8827 take precedence)}
- 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 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity}
- A61F 2/4611: {of spinal prostheses}
- A61F 2002/3008: {radio-opaque, e.g. radio-opaque markers}
- A61F 2002/30548: {for adjusting fluid pressure}
- A61F 2002/30581: {having a pocket filled with fluid, e.g. liquid}
- A61F 2002/30583: {filled with hardenable fluid, e.g. curable in-situ}
- A61F 2002/30586: {having two or more inflatable pockets or chambers}
- A61M 2025/1013: {with concentrically mounted balloons, e.g. being independently inflatable}
- A61M 2025/1054: {having detachable or disposable balloons}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present disclosure includes devices, apparatuses, kits, and methods for replacing a nucleus pulposus of an intervertebral disc with an implantable nuclear prosthesis filled with a curable silicone material in situ. Configurations of the present spinal implant devices include a flexible body defining an outer fillable enclosure that defines an outer chamber, an inner fillable enclosure that defines an inner chamber, and a proximal plug configured to be coupled to the inner fillable enclosure.

## Claims

### Claim 1

A kit for implanting a nuclear prosthesis, the kit comprising:
a spinal implant device comprising:
a flexible body defining:
an outer fillable enclosure defining an outer chamber having a body aperture; and
an inner fillable enclosure defining an inner chamber such that the outer fillable enclosure at least partially surrounds the inner fillable enclosure, the inner fillable enclosure having an opening in fluid communication with the inner chamber; and
a proximal plug configured to be coupled to the inner fillable enclosure such that the proximal plug controls fluid communication through the opening, the proximal plug defines a receptacle including a plug aperture and including a re-sealable membrane to control fluid communication through a proximal opening of the inner chamber, the receptacle including a first retaining element configured to couple with a second retaining element of an inflation stylet, the plug aperture being positioned between the first retaining element and the re-sealable membrane and configured to enable fluid communication to the outer fillable enclosure; and
the inflation stylet configured to mate with the proximal plug and extend at least partially through the proximal plug, the inflation stylet comprising:
a first lumen configured to deliver a fluid to and remove a fluid from the inner chamber;
a second lumen surrounding the first lumen and configured to deliver a fluid to the outer chamber; and
the second retaining element configured to control insertion depth of the inflation stylet and to secure the inflation stylet to the proximal plug.

### Claim 2 (depends on 1)

The kit of claim 1, where the inflation stylet further comprises an inflation tip for delivering fluid to the outer chamber, the inflation tip configured to be coupled to a distal end of the inflation stylet.

### Claim 3 (depends on 1)

The kit of claim 1, where the inner chamber has a proximal end with the proximal opening and a distal end with a distal opening.

### Claim 4 (depends on 1)

The kit of claim 1, where the outer fillable enclosure and inner fillable enclosure are axially symmetric around a longitudinal axis.

### Claim 5 (depends on 1)

The kit of claim 1, where the inflation stylet further comprises a vent lumen in fluid communication with the second lumen.

### Claim 6 (depends on 1)

The kit of claim 1, further comprising one or more imaging balloons configured to assess a nuclectomy, interrogate an enucleated intervertebral disc cavity, and/or determine a size and a fill volume for the spinal implant device.

### Claim 7 (depends on 1)

The kit of claim 1, comprising:
a first imaging balloon with a durometer between Shore 10A and Shore 100A; and
a second imaging balloon with a durometer greater than the durometer of the first imaging balloon.

### Claim 8 (depends on 1)

The kit of claim 1, further comprising a delivery sheath surrounding the inflation stylet, where the delivery sheath is movable from a delivery position to a deployed position.

### Claim 9 (depends on 1)

The kit of claim 1, further comprising one or more of a curable silicone material for injection into the outer chamber, a spinal disc access device, a spinal implant fill device, where the spinal implant fill device comprises a dispenser gun for injecting fluid into the outer chamber, a dual-syringe barrel, a mixing tip, an inflation pressure gauge, or a combination thereof.

### Claim 10

A spinal implant device comprising:
a flexible body defining:
an outer fillable enclosure defining an outer chamber having a body aperture; and
an inner fillable enclosure defining an inner chamber such that the outer fillable enclosure surrounds the inner fillable enclosure, the inner fillable enclosure having an opening in fluid communication with the inner chamber; and
a proximal plug configured to be coupled to the inner fillable enclosure such that the proximal plug controls fluid communication through the opening, the proximal plug defines a receptacle including a plug aperture and including a re-sealable membrane to control fluid communication through a proximal opening of the inner chamber, the receptacle including a first retaining element configured to couple with a second retaining element of an inflation stylet, the plug aperture being positioned between the first retaining element and the re-sealable membrane and configured to enable fluid communication to the outer fillable enclosure.

### Claim 11 (depends on 10)

The spinal implant device of claim 10, where the inner chamber is configured to provide pressure feedback when the outer chamber is filled.

### Claim 12 (depends on 10)

The spinal implant device of claim 10, where the flexible body comprises a coating containing one or more ingredients selected from a list of ingredients consisting of: drugs, bioactives, and/or stem cells.

### Claim 13 (depends on 10)

The spinal implant device of claim 10, where the inner and outer fillable enclosures comprise a unitary piece of material.

### Claim 14 (depends on 10)

The spinal implant device of claim 10, where the inner chamber has a proximal end with a proximal opening and a distal end with a distal opening, and where the outer fillable enclosure and inner fillable enclosure are axially symmetric around a longitudinal axis.

### Claim 15 (depends on 10)

The spinal implant device of claim 10, where the flexible body further defines a proximal opening in fluid communication with the inner chamber, a distal opening in fluid communication with the inner chamber, or both.

### Claim 16 (depends on 15)

The spinal implant device of claim 15, where the spinal implant device further comprises a distal plug that seals the distal opening.

### Claim 17 (depends on 10)

The spinal implant device of claim 10, where the proximal plug defines:
the receptacle configured to receive a portion of the inflation stylet for delivering a fluid to the inner and outer chambers; and
the plug aperture in fluid communication with the outer chamber when aligned with the body aperture.

### Claim 18 (depends on 17)

The spinal implant device of claim 17, where the inflation stylet comprises an inflation tip for delivering the fluid to the outer chamber, the inflation tip configured to be coupled to a distal end of the inflation stylet.

### Claim 19 (depends on 10)

The spinal implant device of claim 10, where the spinal implant device further comprises a first radiopaque marker coupled to either a distal plug or a portion of the flexible body that is closer to a distal opening of the inner chamber than to the proximal opening of the inner chamber.

### Claim 20 (depends on 19)

The spinal implant device of claim 19, where the spinal implant device further comprises a second radiopaque marker coupled to either the proximal plug or a portion of the flexible body that is closer to the proximal opening of the inner chamber than to a distal opening of the inner chamber.

### Claim 21 (depends on 10)

The spinal implant device of claim 10, where the outer chamber is filled with a curable medium.

### Claim 22 (depends on 21)

The spinal implant device of claim 21, where the curable medium comprises a radiographic material, cures within ten minutes, or both.

### Claim 23 (depends on 22)

The spinal implant device of claim 22, where the radiographic material comprises 8 to 16 wt. % of barium sulfate.

### Claim 24 (depends on 10)

The spinal implant device of claim 10, wherein the re-sealable membrane has a thickness of between 0.6 mm and 1.0 mm, and wherein the re-sealable membrane is configured to function as a one-way valve and prevent any backflow of fluid from the inner chamber into the outer chamber when a fluid is delivered into the inner chamber.

### Claim 25 (depends on 10)

The spinal implant device of claim 10, wherein the second retaining element includes a key or groove, and wherein the second retaining element has a diameter between 1.8 mm and 2.2 mm at a widest point.