# US 2016/0256602 A1 · Implantable polymer for bone and vascular lesions

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- Number: US 2016/0256602 A1
- Document ID: US20160256602A1
- Status: Published application
- Kind: A1
- Application number: 15/156,782
- Filed: 2016-05-17
- Published: 2016-09-08
- Earliest claimed: 2010-10-20
- Assignees: 206 ORTHO, Inc.
- Applicants: 206 ORTHO, Inc.
- Inventors: Jeffrey A. D'Agostino; Andrew J. Carter; Craig M. Jones; Arthur C. Watterson
- Web page: https://patentgrep.com/patent/US20160256602A1

## CPC

- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/26: Mixtures of macromolecular compounds
- A61L 27/446: {with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46}
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/48: with macromolecular fillers
- A61L 27/52: Hydrogels or hydrocolloids
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 27/58: Materials at least partially resorbable by the body
- A61P 19/00: Drugs for skeletal disorders
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 35/00: Antineoplastic agents
- A61L 2300/406: Antibiotics
- A61L 2300/604: Biodegradation
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A solidifying prepolymeric implant composition comprising a biocompatible prepolymer and an optional filler. One such implant composition is a polyurethane implant composition comprising an isocyanate, such as hydroxymetbylenediisocyanate (HMDI) and an alcohol, such as polycaprolactonediol (PCL diol). The compositions of the invention are useful for improving bone structure in patients by applying the solidifying implant composition to bone, reinforcing bone structure, improving load bearing capacity and/or aiding healing of microfractures.

## Claims

### Claim at position 1

-20. (canceled)

### Claim 21

A prepolymeric composition that solidifies into a biocompatible implant, the prepolymeric composition comprising a first prepolymer, a second prepolymer, a first filler and a second filler, the first prepolymer comprising crosslinkable groups, the second prepolymer comprising biodegradable groups, the first filler being a fiber, and the second filler being a particulate.

### Claim 22 (depends on 21)

A prepolymeric composition according to claim 21 wherein the first prepolymer is disposed internal to the second prepolymer.

### Claim 23 (depends on 21)

A prepolymeric composition according to claim 21 wherein the first filler is disposed in the first prepolymer, and the second filler is disposed in the second prepolymer.

### Claim 24 (depends on 21)

A prepolymeric composition according to claim 21 wherein the solidification of the biocompatible implant is due to the crosslinking of multifunctional alcohol and isocyanate groups.

### Claim 25 (depends on 24)

A prepolymeric composition according to claim 24 wherein the multifunctional alcohol comprises at least one from the group consisting of triol and diol.

### Claim 26 (depends on 21)

A prepolymeric composition according to claim 21 wherein the crosslinking of the first prepolymer is enabled due to a catalyst comprising a metal salt.

### Claim 27 (depends on 21)

A prepolymeric composition according to claim 21 wherein the solidification of the biocompatible implant is due to radical polymerization of an acrylate group.

### Claim 28 (depends on 21)

A prepolymeric composition according to claim 21 wherein the first prepolymer further comprises biodegradable groups.

### Claim 29 (depends on 27)

A prepolymeric composition according to claim 27 wherein the solidification of the biocompatible implant is due to crosslinkable polymerization enabled by a photoinitiator.

### Claim 30 (depends on 21)

A prepolymeric composition according to claim 21 wherein the prepolymeric composition has a working time of 3-20 minutes.

### Claim 31 (depends on 21)

A prepolymeric composition according to claim 21 wherein the prepolymeric composition has a set time of 24 hours or less.

### Claim 32 (depends on 21)

A prepolymeric composition according to claim 21 wherein the solidified biocompatible implant is configured to simultaneously deliver biologically active material.

### Claim 33 (depends on 32)

A prepolymeric composition according to claim 32 wherein the biologically active material is selected from the group consisting of a therapeutic, an antibiotic, a drug, a cancer treatment agent, an anti-blood clotting agent, a radio-opaque material, and a contrast agent.

### Claim 34 (depends on 32)

A prepolymeric composition according to claim 32 wherein the biologically active material is a glycosaminoglycan.

### Claim 35 (depends on 21)

A prepolymeric composition according to claim 21 wherein the strain-to-yield of the solidified biocompatible implant is >2.5%.

### Claim 36 (depends on 21)

A prepolymeric composition according to claim 21 wherein the compressive strength of the solidified biocompatible implant is 10-500 Mpa.

### Claim 37 (depends on 21)

A prepolymeric composition according to claim 21 wherein the compressive stiffness of the solidified biocompatible implant is 0.25-20 GPa.

### Claim 38 (depends on 21)

A prepolymeric composition according to claim 21 wherein at least one of the first and second fillers is a porogen.

### Claim 39 (depends on 38)

A prepolymeric composition according to claim 38 wherein the porogen creates pores in the range of 1-1000 microns.

### Claim 40 (depends on 38)

A prepolymeric composition according to claim 38 wherein the porogen is selected from the group consisting of βTCP, αTCP, calcium carbonate, calcium sulfate, and bioactive glass.

### Claim 41 (depends on 21)

A prepolymeric composition according to claim 21 wherein at least one of the first and second fillers is a visualization agent.

### Claim 42 (depends on 41)

A prepolymeric composition according to claim 41 wherein the visualization agent is selected from the group consisting of barium sulfate, nickel-titanium, trufill n-butyl cyanoacrylate, ethiodol, Tantalum, Platinum, Barium, Titanium, Silver, Gold, Palladium, Iridium, Osmium, Copper, Niobium, Molybdenum, Strontium and Gallium and/or alloys such as Nickel-Titanium, Nickel-Manganese-Gallium, Platinum-Iridium and Platinum-Osmium, and tantalum.

### Claim 43 (depends on 21)

A prepolymeric composition according to claim 21 further comprising a reducing agent.

### Claim 44 (depends on 43)

A prepolymeric composition according to claim 43 wherein the reducing agent is selected from the group consisting of an amine, a mercaptan, a tertiary aromatic amine, formic acid, and an alcohol.

### Claim 45 (depends on 21)

A prepolymeric composition according to claim 21 wherein the strength retention time is 6-26 weeks.

### Claim 46 (depends on 21)

A prepolymeric composition according to claim 21 wherein the degradation time is <60 months.