# US 2008/0188858 A1 · Bone treatment systems and methods

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- Number: US 2008/0188858 A1
- Document ID: US20080188858A1
- Status: Published application
- Kind: A1
- Application number: 12/024,969
- Filed: 2008-02-01
- Published: 2008-08-07
- Earliest claimed: 2007-02-05
- Inventors: Robert Luzzi; John H. Shadduck; Csaba Truckai
- Web page: https://patentgrep.com/patent/US20080188858A1

## CPC

- A61L 24/0084: {containing fillers of phosphorus-containing inorganic compounds, e.g. apatite}
- A61B 17/8822: {characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum}
- A61B 17/8836: {for heating, cooling or curing of bone cement or fluid fillers}
- A61L 24/02: containing inorganic materials
- A61L 24/06: obtained by reactions only involving carbon-to-carbon unsaturated bonds {(A61L24/043, A61L24/046 take precedence)}
- A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61B 2017/00026: {Conductivity or impedance, e.g. of tissue}
- A61B 2017/00088: {using thermistors}
- A61B 2017/00101: {using an array of thermosensors}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Bone cement formulations are provided that have an extended working time for use in vertebroplasty procedures and other osteoplasty procedures. In one embodiment, a settable bone cement includes a polymerizable composition with a powder component comprising an X-Ray contrast medium and a liquid component, wherein the setting time of the cement is at least about 25 minutes, at least about 30 minutes, at least about 35 minutes, and at least about 40 minutes.

## Claims

### Claim 1

A settable bone cement, comprising:
a polymerizable composition comprising:
a powder component comprising an X-Ray contrast medium and;
a liquid component;
wherein the cement has a setting time of about 25 minutes or more.

### Claim 2 (depends on 1)

A bone cement according to claim 1, wherein the powder component further comprises polymethyl methacrylate (PMMA) that is about 64% to 75% by weight based on overall weight of the powder component.

### Claim 3 (depends on 1)

A bone cement according to claim 1, wherein the amount of X-ray contrast medium is about 27% to 32% by weight based on overall weight of the powder component.

### Claim 4 (depends on 1)

A bone cement according to claim 1, wherein the X-ray contrast medium is selected from the group consisting of barium sulfate (BaSO4) and zirconium dioxide (ZrO2).

### Claim 5 (depends on 1)

A bone cement according to claim 1, further including benzoyl peroxide (BPO) that is about 0.4% to 0.8% by weight based on overall weight of the powder component.

### Claim 6 (depends on 1)

A bone cement according to claim 1, wherein the liquid component comprises methyl methacrylate (MMA) that is greater than about 99% by weight based on overall weight of the liquid component.

### Claim 7 (depends on 1)

A bone cement according to claim 1, wherein the liquid component comprises N,N-dimethyl-p-toluidine (DMPT) that is less than about 1% by weight based on overall weight of the liquid component.

### Claim 8 (depends on 1)

A bone cement according to claim 1, wherein the liquid component includes hydroquinone that ranges between about 30 and 120 ppm of the liquid component.

### Claim 9 (depends on 1)

A bone cement according to claim 1, wherein the liquid weight/powder weight ratio is equal to or greater than about 0.4.

### Claim 10 (depends on 1)

A bone cement according to claim 1, wherein the PMMA comprises particles having a mean diameter ranging from about 25 microns to 200 microns.

### Claim 11 (depends on 1)

A bone cement according to claim 1, wherein the PMMA comprises particles having a mean diameter ranging from about 50 microns to 100 microns.

### Claim 12 (depends on 1)

A bone cement according to claim 1, further comprising a filler selected from at least one of chromophores, ferromagnetic materials, a fluid that thermally responds to microwaves, a bone ingrowth accelerator, a bioactive agent, and a thermally insulating solid.

### Claim 13

A settable bone cement comprising:
a powder component comprising polymethyl methacrylate (PMMA) and;
a liquid component;
wherein the bone cement provides a setting time of at least 25 minutes.

### Claim 14 (depends on 13)

A settable bone cement as in claim 13, wherein the bone cement provides a setting time of at least 30 minutes.

### Claim 15 (depends on 13)

A settable bone cement as in claim 13, wherein the bone cement provides a setting time of at least 35 minutes.

### Claim 16 (depends on 13)

A settable bone cement as in claim 13, wherein the bone cement provides a setting time of at least 40 minutes.

### Claim 17

A bone cement comprising:
a powder component comprising:
about 64 to 75 wt. % PMMA;
about 27 to 32 wt. % of an X-ray contrast medium; and
about 0.4 to 0.8 wt. % benzoyl peroxide (BPO);
wherein the amount of each is on the basis of the total weight of the powder component; and
a liquid component comprising:
greater than about 99 wt. % methyl methacrylate (MMA);
less than about 1 wt. % N,N-dimethyl-p-toluidine (DMPT), about 30 to 120 ppm hydroquinone;
wherein the amount of each on the basis of the total amount of the liquid component.

### Claim 18 (depends on 17)

The bone cement according to claim 17, wherein the ratio of the weight of the liquid component to the weight of the powder component is equal to or greater than about 0.4.

### Claim 19 (depends on 17)

A bone cement according to claim 17, further comprising a filler selected from at least one of chromophores, ferromagnetic materials, a fluid that thermally responds to microwaves, a bone ingrowth accelerator, a bioactive agent, and a thermally insulating solid.

### Claim 20

A method for injecting a bone cement to treat an abnormality in a bone, comprising:
providing a bone cement having a setting time of about 25 minutes or more;
injecting said bone cement into a vertebra of a patient using a bone cement injector system; and
applying energy to the bone cement from an energy emitter in the injector system to thereby increase the viscosity of the bone cement and accelerate said setting time.

### Claim 21 (depends on 20)

The method as in claim 20, wherein the bone cement comprises:
a powder component comprising:
about 64 to 75 wt. % PMMA;
about 27 to 32 wt. % of an X-ray contrast medium; and
about 0.4 to 0.8 wt. % benzoyl peroxide (BPO);
wherein the amount of each is on the basis of the total weight of the powder component; and
a liquid component comprising:
greater than about 99 wt. % methyl methacrylate (MMA);
less than about 1 wt. % N,N-dimethyl-p-toluidine (DMPT), about 30 to 120 ppm hydroquinone;
wherein the amount of each is on the basis of the total amount of the liquid component.

### Claim 22 (depends on 20)

The method of claim 20, wherein the energy emitter comprises a thermal energy emitter configured to deliver thermal energy to the bone cement.

### Claim 23 (depends on 22)

The method of claim 22, wherein the thermal energy emitter comprises at least one of a resistive heating element, an Rf emitter, a light energy emitter, an inductive heating emitter, an ultrasound emitter, and a microwave emitter.

### Claim 24 (depends on 20)

The method of claim 20, wherein the X-ray contrast medium is selected from the group consisting of barium sulfate (BaSO4) and zirconium dioxide (ZrO2).

### Claim 25 (depends on 20)

The method of claim 20, wherein the liquid weight/powder weight ratio is equal to or greater than about 0.4.

### Claim 26 (depends on 20)

The method of claim 20, further comprising providing a bone cement having a setting time of at least 30 minutes.

### Claim 27 (depends on 20)

The method of claim 20, further comprising providing a bone cement having a setting time of at least 35 minutes.

### Claim 28 (depends on 20)

The method of claim 20, further comprising providing a bone cement having a setting time of at least 40 minutes.

### Claim 29

A method for anchoring an implant member in a bone with a bone cement, comprising:
positioning an implant member in a bone of a patient;
injecting a bone cement within the region of the bone-implant interface with an injector system, wherein said bone cement has a setting time of about 25 minutes or more; and
applying energy to the bone cement from the injector system to thereby increase the viscosity of the bone cement and accelerate said setting time.

### Claim 30 (depends on 29)

The method as in claim 29, wherein the bone cement comprises:
a powder component comprising:
about 64 to 75 wt. % PMMA;
about 27 to 32 wt. % of an X-ray contrast medium; and
about 0.4 to 0.8 wt. % benzoyl peroxide (BPO);
wherein the amount of each is on the basis of the total weight of the powder component; and
a liquid component comprising:
greater than about 99 wt. % methyl methacrylate (MMA);
less than about 1 wt. % N,N-dimethyl-p-toluidine (DMPT), about 30 to 120 ppm hydroquinone;
wherein the amount of each on the basis of the total amount of the liquid component.

### Claim 31 (depends on 29)

The method as in claim 29, wherein the implant member comprises at least one of anchors, screws, plates, supports, ports, rods and a prosthesis.

### Claim 32

A bone cement kit comprising:
a bone cement, comprising a powder component, comprising polymethyl methacrylate (PMMA), and a liquid component, wherein the bone cement provides a setting time of about 25 minutes or more; and
a bone cement injector system configured to apply energy to the bone cement to thereby increase the viscosity of the bone cement and accelerate said setting time of said bone cement.

### Claim 33 (depends on 32)

A bone cement kit according to claim 32, wherein the bone cement injector system includes a positive temperature coefficient of resistance (PTCR) material operatively coupled to a voltage source.

### Claim 34 (depends on 32)

A bone cement kit according to claim 32, wherein the bone cement injector system is operatively coupled to at least one energy source comprising an electromagnetic energy source, a radiofrequency source, a resistive heating source, a coherent light source, a non-coherent light source, a microwave source, a magnetic source, and an ultrasound source.
