# US 2010/0168271 A1 · Bone cement and methods of use thereof

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- Number: US 2010/0168271 A1
- Document ID: US20100168271A1
- Status: Published application
- Kind: A1
- Application number: 12/377,894
- Filed: 2007-09-11
- Published: 2010-07-01
- Earliest claimed: 2006-09-14
- Assignees: DePuy Spine, Inc.
- Inventors: Mordechay Beyar; Oren Globerman
- Web page: https://patentgrep.com/patent/US20100168271A1

## CPC

- A61L 24/06: obtained by reactions only involving carbon-to-carbon unsaturated bonds {(A61L24/043, A61L24/046 take precedence)}
- A61L 24/0005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 24/02: containing inorganic materials
- A61L 24/046: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds (A61L24/043 takes precedence)}
- A61K 6/15: Compositions characterised by their physical properties
- 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)

## Abstract

A bone cement comprising an acrylic polymer mixture which is formulated to have a relatively high viscosity for a relatively long window, due to distributions of molecular weights and/or sizes of acrylic beads.

## Claims

### Claim 1

A bone cement comprising an acrylic polymer mixture, the cement characterized in that it achieves a viscosity of at least 500 Pascal-second within 180 seconds following initiation of mixing of a monomer component and a polymer component and characterized by sufficient biocompatibility to permit in-vivo use.

### Claim 2 (depends on 1)

A bone cement according to claim 1, wherein the viscosity of the mixture remains between 500 and 2000 Pascal-second for a working window of at least 5 minutes after the initial period.

### Claim 3 (depends on 2)

A bone cement according to claim 2, wherein the working window is at least 8 minutes long.

### Claim 4 (depends on 1)

A bone cement according to claim 1, wherein the mixture includes PMMA.

### Claim 5 (depends on 1)

A bone cement according to claim 1, wherein the mixture includes Barium Sulfate.

### Claim 6 (depends on 4)

A bone cement according to claim 4, wherein the PMMA is provided as a PMMA/styrene copolymer.

### Claim 7 (depends on 4)

A bone cement according to claim 4, wherein the PMMA is provided as a population of beads divided into at least two sub-populations, each sub-population characterized by an average molecular weight.

### Claim 8 (depends on 7)

A bone cement according to claim 7, wherein a largest sub-population of PMMA beads is characterized by an MW of 150,000 Dalton to 300,000 Dalton.

### Claim 9 (depends on 7)

A bone cement according to claim 7, wherein a largest sub-population of PMMA beads includes 90-98% (w/w) of the beads.

### Claim 10 (depends on 7)

A bone cement according to claim 7, wherein a high molecular weight sub-population of PMMA beads is characterized by an average MW of at least 3,000,000 Dalton.

### Claim 11 (depends on 7)

A bone cement according to claim 7, wherein a high molecular weight sub-population of PMMA beads includes 2 to 3% (w/w) of the beads.

### Claim 12 (depends on 7)

A bone cement according to claim 7, wherein a low molecular weight sub-population of PMMA beads is characterized by an average MW of less than 15,000 Dalton.

### Claim 13 (depends on 7)

A bone cement according to claim 7, wherein a low molecular weight sub-population of PMMA beads includes 0.75 to 1.5% (W/W) of the beads.

### Claim 14 (depends on 4)

A bone cement according to claim 4, wherein the PMMA is provided as a population of beads divided into at least two sub-populations, each sub-population characterized by an average bead diameter.

### Claim 15 (depends on 14)

A bone cement according to claim 14, wherein at least one bead sub-population of characterized by an average diameter is further divided into at least two sub-sub-populations, each sub-sub-population characterized by an average molecular weight.

### Claim 16 (depends on 14)

A bone cement according to claim 14, wherein the PMMA is provided as a population of beads divided into at least three sub-populations, each sub-population characterized by an average bead diameter.

### Claim 17 (depends on 1)

A bone cement according to claim 1, further comprising processed bone and/or synthetic bone.

### Claim 18 (depends on 1)

A bone cement according to claim 1, characterized in that the cement achieves a viscosity of at least 500 Pascal-second when 100% of a polymer component is wetted by a monomer component.

### Claim 19 (depends on 1)

A bone cement according to claim 1, wherein the viscosity is at least 800 Pascal-second.

### Claim 20 (depends on 1)

A bone cement according to claim 1, wherein the viscosity is at least 1500 Pascal-second.

### Claim 21 (depends on 1)

A bone cement according to claim 1, wherein the viscosity is achieved within 2 minutes.

### Claim 22 (depends on 1)

A bone cement according to claim 1, wherein the viscosity is achieved within 1 minute.

### Claim 23 (depends on 1)

A bone cement according to claim 1, wherein the viscosity is achieved within 45 seconds.

### Claim 24

A bone cement comprising:
a polymer component; and
a monomer component;
wherein contacting the polymer component and the monomer component produces a mixture which attains a viscosity greater than 200 Pascal-second within 1 minute from onset of mixing and remains below 2000 Pascal-second until at least 6 minutes from onset of mixing.

### Claim 25 (depends on 24)

A bone cement according to claim 24, wherein the polymer component comprises an acrylic polymer.

### Claim 26

A particulate mixture formulated for preparation of a bone cement, the mixture comprising:
(a) 60 to 80% polymer beads comprising a main sub-population characterized by an MW of 150,000 Dalton to 300,000 Dalton and a high molecular weight sub-population characterized by an MW of 3,000,000 Dalton to 4,000,000 Dalton; and
(b) 20 to 40% of a material which is non-transparent with respect to X-ray.

### Claim 27 (depends on 26)

A mixture according to claim 26, wherein the polymer beads comprise a third subpopulation characterized by an MW of 10,000 Dalton to 15,000 Dalton.

### Claim 28

A method of making a polymeric bone cement, the method comprising:
(a) defining a viscosity profile including a rapid transition to a working window characterized by a high viscosity;
(b) selecting a polymer component and a monomer component to produce a cement conforming to the viscosity profile; and
(c) mixing the polymer component and a monomer component to produce a cement which conforms to the viscosity profile.

### Claim 29

A cement kit, comprising:
(a) a liquid component including a monomer; and
(b) a powder component including polymeric beads,
characterized in that said powder component is provided in a substantially non-normal distribution of at least one of molecular weight of the polymeric beads and size of powder particles such that a cement mixed from the kit has both an increased immediate viscosity and an increased working window as compared to a cement having a substantially normal distribution.

### Claim 30 (depends on 29)

A cement kit according to claim 29, wherein said substantially non-normal distribution is a skewed distribution.

### Claim 31 (depends on 29)

A cement kit according to claim 29, wherein said substantially non-normal distribution comprises a relatively small component including higher molecular weight beads.

### Claim 32 (depends on 31)

A cement kit according to claim 31, wherein said component has an average molecular weight of at least a factor of 2 of an average molecular weight of said polymeric beads. s.

### Claim 33 (depends on 32)

A cement kit according to claim 32, wherein said factor is at least 3.

### Claim 34 (depends on 32)

A cement kit according to claim 32, wherein said factor is at least 5.

### Claim 35 (depends on 29)

A cement kit according to claim 29, wherein said substantially non-normal distribution comprises a relatively small component including smaller sized particles.