# US 2014/0194887 A1 · Device, Composition and Method for Prevention of Bone Fracture and Pain

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- Number: US 2014/0194887 A1
- Document ID: US20140194887A1
- Status: Published application
- Kind: A1
- Application number: 14/238,769
- Filed: 2012-08-10
- Published: 2014-07-10
- Earliest claimed: 2011-08-15
- Inventors: Vivek Shenoy
- Web page: https://patentgrep.com/patent/US20140194887A1

## CPC

- A61B 17/8811: {characterised by the introducer tip, i.e. the part inserted into or onto the bone}
- A61B 17/8816: {characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections}
- A61B 17/8833: {Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means}
- A61B 17/8836: {for heating, cooling or curing of bone cement or fluid fillers}
- A61L 27/52: Hydrogels or hydrocolloids
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00084: {Temperature}
- A61B 2017/00495: {for two-component glue}
- A61B 2017/005: {hardenable using external energy source, e.g. laser, ultrasound}
- A61B 2017/00942: {hydrophilic}
- A61B 2017/8838: {for mixing bone cement or fluid fillers}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2218/007: Aspiration
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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

Methods, apparatus, compositions for reinforcing bone structures are disclosed as well as a reinforced bone structure itself. By injecting a low viscosity polymeric solution into a trabecular bone region at least partly surrounded by cortical bone allowing it to cross-link in-situ, a non-degradable gel can effectively reinforce the region by retaining fluid in the constrained space within the cortical shell. Due to the low viscosity of the pre-cross-linked aqueous polymeric solution, the entire site could be filled effectively and consistently. Additionally, by injecting a low viscosity pre-cursor, the solution fills the natural intra-trabecular spaces without substantial alteration of the trabecular structure at the site.

## Claims

### Claim at position 1

1-56. (canceled)

### Claim 57

A method for reinforcing a bone having a region of trabecular bone surrounded at least in part by a layer of cortical bone, the method comprising:
delivering an aqueous solution of an at least substantially non-cross-linked polymer into the region of trabecular bone; and
cross-linking the polymer in situ to form a non-degradable hydrogel.

### Claim 58 (depends on 57)

The method in claim 57, wherein said delivering comprises filling substantially more than half of the volume of interstices defined by the region of trabecular bone with said aqueous solution.

### Claim 59 (depends on 57)

The method of claim 57, further comprising aspirating marrow out of the trabecular bone before delivering said aqueous solution.

### Claim 60 (depends on 57)

The method in claim 57, wherein the bone is osteopenic or osteoporotic.

### Claim 61 (depends on 57)

The method in claim 57, wherein the hydrogel is bioinert.

### Claim 62 (depends on 57)

The method in claim 57, wherein said delivering comprises filling substantially more than 75% of the volume of interstices defined by the region of trabecular bone with said aqueous solution.

### Claim 63 (depends on 57)

The method in claim 57, wherein the trabecular bone structure is unaltered by said delivering and cross-linking.

### Claim 64 (depends on 57)

The method in claim 57, wherein the region of trabecular bone comprises a femoral head and femoral neck.

### Claim 65 (depends on 57)

The method in claim 57, wherein the region of trabecular bone comprises a vertebral body.

### Claim 66

A method for reinforcing a bone having a region of trabecular bone with a trabecular structure, surrounded at least in part by a layer of cortical bone, the method comprising: injecting an aqueous polymeric solution into the trabecular bone, and filling substantially more than half of the volume of interstices defined by the region of trabecular bone with said aqueous solution, such that the polymer cross-links in situ to form a non-degradable hydrogel, wherein the trabecular structure is not substantially altered.

### Claim 67 (depends on 66)

The method in claim 66, wherein the bone marrow is aspirated out prior to injecting the aqueous polymeric solution.

### Claim 68 (depends on 66)

The method in claim 66, wherein the aqueous polymeric solution injected into the trabecular bone further comprises autologous bone marrow.

### Claim 69 (depends on 66)

The method in claim 66, wherein the region of trabecular bone comprises a femoral head and femoral neck.

### Claim 70 (depends on 66)

The method in claim 66, wherein the region of trabecular bone comprises a vertebral body.

### Claim 71 (depends on 66)

The method in claim 66, wherein the hydrogel is bioinert.

### Claim 72 (depends on 66)

The method in claim 66, wherein the compressive modulus of the crosslinked hydrogel is less than about 1000 kPa.

### Claim 73 (depends on 66)

The method in claim 66, wherein the viscosity of the aqueous polymeric solution prior to injection into the trabecular bone is less than about 100 cP.

### Claim 74 (depends on 66)

The method in claim 66, wherein the region of trabecular bone comprises a femoral head, femoral neck and intertrochanteric region.

### Claim 75

A reinforced bone structure, comprising:
a region of trabecular bone surrounded at least in part by a layer of cortical bone; and
a cross-linked hydrogel filling substantially more than half of the volume of the interstices defined by the region of trabecular bone.

### Claim 76 (depends on 75)

The reinforced bone structure in claim 75, wherein the hydrogel is a non-degradable, bio-inert hydrogel.