# US 2014/0194877 A1 · Orthopedic fastener device

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- Number: US 2014/0194877 A1
- Document ID: US20140194877A1
- Status: Published application
- Kind: A1
- Application number: 14/203,099
- Filed: 2014-03-10
- Published: 2014-07-10
- Earliest claimed: 2008-06-11
- Assignees: Eventions, LLC
- Applicants: Eventions, LLC
- Inventors: Eric K. MANGIARDI
- Web page: https://patentgrep.com/patent/US20140194877A1

## CPC

- A61B 17/72: Intramedullary devices, e.g. pins or nails
- A61B 17/7233: {with special means of locking the nail to the bone}
- A61B 17/7258: {with laterally expanding parts, e.g. for gripping the bone}
- A61B 17/848: {Kirschner wires, i.e. thin, long nails}
- A61B 17/866: {Material or manufacture}
- A61L 31/022: {Metals or alloys}
- A61L 31/10: Macromolecular materials
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61B 17/7291: {for small bones, e.g. in the foot, ankle, hand or wrist}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00898: {expandable upon contact with fluid}
- A61B 2017/681: {Alignment, compression, or distraction mechanisms}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

Orthopedic fastener devices for fixation of fractured bones are disclosed. The orthopedic fastener device is in the form of an orthopedic fastener having an IM nail coated on its external surface with a bioabsorbable or biodegradable hydrogel. Also disclosed are hydrogel coated orthopedic fastener devices in the form of a K-wire or bone screw, a method for stabilizing a fractured long bone fracture by inserting an orthopedic fastener into the medullary canal of the bone and a kit for fastener implantation.

## Claims

### Claim 1

An orthopedic fastener for internal fixation of a fractured long bone comprising an IM nail coated on its external surface with a bioabsorbable or biodegradable hydrogel.

### Claim 2 (depends on 1)

The orthopedic fastener of claim 1, wherein the IM nail comprises a center lumen to accommodate a guide wire.

### Claim 3 (depends on 1)

The orthopedic fastener of claim 1, wherein the orthopedic fastener degrades in situ by hydrolytic reactions, enzymatic reactions, alkaline or pH changes.

### Claim 4 (depends on 1)

The orthopedic fastener of claim 1, wherein the IM nail is manufactured from a biodegradable metal or biodegradable alloy.

### Claim 5 (depends on 4)

The orthopedic fastener of claim 4, wherein the biodegradable metal is magnesium.

### Claim 6 (depends on 4)

The orthopedic fastener of claim 4, wherein the biodegradable alloy comprises magnesium.

### Claim 7 (depends on 4)

The orthopedic fastener of claim 4, wherein the biodegradable alloy comprises rare earth materials.

### Claim 8 (depends on 4)

The orthopedic fastener of claim 4, wherein the biodegradable alloy comprises a magnesium alloy and chitin.

### Claim 9 (depends on 1)

The orthopedic fastener of claim 1, wherein the IM nail is made of a chitin and chitosan, N-acylchitosan hydrogel and magnesium alloy with rare earth elements.

### Claim 10 (depends on 1)

The orthopedic fastener of claim 1, wherein the hydrogel is a chitin chitosan, N-acylchitosan hydrogel.

### Claim 11 (depends on 1)

The orthopedic fastener of claim 1, wherein the hydrogel swells to about 30% of its maximal diameter within 10 minutes after coming in contact with moisture.

### Claim 12

A method for stabilizing a bone fracture comprising, inserting an orthopedic fastener into the medullary canal of a bone having a fracture, wherein said orthopedic fastener comprises an IM nail coated on its external surface with a bioabsorbable or biodegradable hydrogel.

### Claim 13 (depends on 12)

The method of claim 12, wherein the orthopedic fastener is placed through the bone cortex.

### Claim 14 (depends on 12)

The method of claim 12, wherein the orthopedic fastener degrades in situ by hydrolytic reactions, enzymatic reactions, alkaline or pH changes.

### Claim 15

A kit for fastener implantation in a fractured long bone, said kit comprising:
an orthopedic fastener comprising an IM nail coated on its external surface with a bioabsorbable or biodegradable hydrogel;
a guide wire;
and a pusher that is movable along the guide wire.

### Claim 16 (depends on 15)

The kit of claim 15, wherein the IM nail is made of a bioabsorbable material.

### Claim 17 (depends on 15)

The kit of claim 15, wherein the IM nail further comprises a center lumen to accommodate the guide wire.

### Claim 18 (depends on 15)

The kit of claim 15, wherein the IM nail is made of a magnesium alloy and chitin.

### Claim 19 (depends on 15)

The kit of claim 15, wherein the IM nail is made with a magnesium core coated with a chitin chitosan, N-acylchitosan hydrogel outer layer.

### Claim 20 (depends on 15)

The kit of claim 15, wherein the IM nail is made of a chitin and chitosan, N-acylchitosan hydrogel and magnesium alloy with raw earth elements.

### Claim 21

An orthopedic fastener device for fixation of a fractured bone comprising a K-Wire coated on its external surface with a bioabsorbable or biodegradable hydrogel.

### Claim 22

An orthopedic fastener device for fixation of a fractured bone, comprising a bone screw coated on its external surface with a bioabsorbable or biodegradable hydrogel.

### Claim 23 (depends on 22)

The orthopedic fastener device of claim 22, wherein said bone screw is a Scaphoid screw for fixation of a fractured carpal or tarsal bone.
