# US 12,274,811 B2 · Dural repair device and method of use

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- Number: US 12,274,811 B2
- Document ID: US12274811B2
- Status: Granted
- Kind: B2
- Application number: 18/205,099
- Filed: 2023-06-02
- Published: 2023-10-05
- Granted: 2025-04-15
- Earliest claimed: 2017-09-12
- Assignees: University of Maryland, Baltimore
- Applicants: University of Maryland, Baltimore
- Inventors: Charles Sansur; Steven C. Ludwig
- Web page: https://patentgrep.com/patent/US12274811B2

## CPC

- A61L 27/3675: {Nerve tissue, e.g. brain, spinal cord, nerves, dura mater}
- A61B 17/8028: {Cushions, i.e. elements forming interface between bone plate and bone}
- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- 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)}
- A61L 27/14: Macromolecular materials
- A61L 27/58: Materials at least partially resorbable by the body
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61B 17/7071: {Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor}
- A61F 2002/30179: {X-shaped}
- A61F 2002/30973: {Two joined adjacent layers having complementary interlocking protrusions and recesses}
- A61F 2002/4435: {Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes}
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2250/0037: differing in height or in length
- A61L 2430/32: for nerve reconstruction
- A61M 2039/0226: {having means for protecting the interior of the access site from damage due to the insertion of a needle}
- A61M 2039/0264: {with multiple inlets or multiple outlets}
- A61M 2039/027: {having a particular valve, seal or septum}
- A61M 2039/0276: {for introducing or removing fluids into or out of the body}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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

Dural repair devices that are configured to effectively and reliably repair the damage of a dural tear due to incidental durotomies are provided, along with methods of use. The devices and methods enhance the ability of a surgeon to repair a patent's dura mater, or dura, during surgery of the central nervous system. The dural repair device has a multi-layer structure configured to exert a pressure or tamponade effect to compress a patient's dura to its state prior to the spinal surgery. Thus, the dural repair devices and methods of use may reduce the patient's risk morbidity, further surgery, spinal headaches, or other injuries and discomforts.

## Claims

### Claim 1

Method of sealing a treatment site for a dural repair, comprising:
providing a dual layer, multi-composite plate having a top layer and an attached bottom layer, the top layer comprising a rigid and formable resorbable thermoplastic material, the bottom layer comprising a compressible material softer than the thermoplastic material of the top layer, the plate being moldable under heat treatment and being configured to provide a water-tight seal over a treatment site, wherein the plate includes a valvular pore for insertion of a needle therethrough, the valvular pore being configured to provide one-way fluid flow;
forming a sealing device over the treatment site from the multi-composite plate; and
securing the formed sealing device to the treatment site.

### Claim 2 (depends on 1)

The method of claim 1, wherein the step of forming the sealing device includes application of a heat treatment.

### Claim 3 (depends on 2)

The method of claim 2, wherein the heat treatment includes warm water.

### Claim 4 (depends on 1)

The method of claim 1, wherein the step of forming the sealing device includes cutting the plate to a desired size or shape.

### Claim 5 (depends on 1)

The method of claim 1, wherein the step of forming the sealing device includes molding the plate into a desired shape.

### Claim 6 (depends on 1)

The method of claim 1, wherein the step of securing includes suturing the sealing device to the treatment site.

### Claim 7 (depends on 1)

The method of claim 1, wherein the step of securing includes inserting a bone fastener through the sealing device to the treatment site.

### Claim 8 (depends on 1)

The method of claim 1, wherein the step of securing applies a tamponade pressure effect to the treatment site.

### Claim 9 (depends on 1)

The method of claim 1, wherein the treatment site is at a laminar defect of a spine.

### Claim 10 (depends on 1)

The method of claim 1, wherein the treatment site is at a cranial defect of a skull.

### Claim 11 (depends on 1)

The method of claim 1, wherein the treatment site is at a repair site of a fascia.

### Claim 12 (depends on 1)

The method of claim 1, wherein the treatment site includes a neural element.

### Claim 13 (depends on 12)

The method of claim 12, wherein the neural element comprises a brain, spinal cord, or nerve root.