# US 9,750,840 B2 · Methods, materials and apparatus for treating bone and other tissue

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- Number: US 9,750,840 B2
- Document ID: US9750840B2
- Status: Granted
- Kind: B2
- Application number: 13/722,081
- Filed: 2012-12-20
- Published: 2013-05-16
- Granted: 2017-09-05
- Earliest claimed: 2004-03-21
- Assignees: DePuy Synthes Products, Inc.
- Applicants: DePuy Synthes Products, Inc.
- Inventors: Mordechay Beyar; Oren Globerman; Ronen Shavit; Hila Wachsler-Avrahami
- Web page: https://patentgrep.com/patent/US9750840B2

## CPC

- A61L 24/06: obtained by reactions only involving carbon-to-carbon unsaturated bonds {(A61L24/043, A61L24/046 take precedence)}
- A61B 17/1671: {for the spine}
- 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 17/8822: {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}
- A61F 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity}
- A61L 24/043: {Mixtures of macromolecular materials}
- A61L 27/26: Mixtures of macromolecular compounds
- B01F 27/95: with stirrers having planetary motion, i.e. rotating about their own axis and about a sun axis
- B01F 35/3202: {Hand driven}
- B01F 35/53: characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components
- B01F 35/75425: {using pistons or plungers}
- B01F 35/754251: {reciprocating in the mixing receptacle}
- A61B 17/1604: {Chisels; Rongeurs; Punches; Stamps}
- A61B 17/3421: {Cannulas}
- A61B 2017/00539: {hydraulically}
- A61B 2017/2905: {flexible}
- A61B 2090/3937: {Visible markers}
- A61F 2/44: for the spine, e.g. vertebrae or spinal discs
- A61F 2002/4693: {hydraulic}
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs
- 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)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- B01F: MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING (mixing paints B44D3/06)

## Abstract

A bone cement comprising a first component and a second component, wherein contacting the first component and the second component produces a mixture which attains a high viscosity an initial period and the viscosity of the mixture remains relatively stable for a working time of at least 5 minutes after the initial setting period, and the mixture is suitable for in-vivo use.

## Claims

### Claim 1

A hydraulic delivery system for delivering bone cement to a patient's vertebra, comprising:
a hydraulic actuator for generating a fluid pressure;
a reservoir having a quantity of bone cement contained therein, the bone cement comprising PMMA polymer and MMA monomer, the PMMA polymer having an average molecular weight and further containing a population of pre-polymerized PMMA beads having a high molecular weight, wherein the high molecular weight is greater than the average molecular weight and wherein the average molecular weight, the high molecular weight, and the percentage of beads having the high molecular weight are selected so that contacting the PMMA polymer and MMA monomer produces a mixture which has a stable high viscosity during a working time and solidifies after the working time;
a flexible tube connected to the hydraulic actuator and to the reservoir to transmit the fluid pressure from the hydraulic actuator to the reservoir; and
a cannula connected to the reservoir such that the fluid pressure from the hydraulic actuator forces bone cement from the reservoir through the cannula;
wherein the bone cement has a stable high viscosity of 200 to 2000 Pascal-second during a working time of at least 5 minutes, the bone cement solidifying after the working time; and
wherein the system is configured to deliver the bone cement to a patient's vertebra during the working time.

### Claim 2 (depends on 1)

The system of claim 1, wherein the viscosity is at least 900 Pascal-seconds during the working time.

### Claim 3 (depends on 1)

The system of claim 1, wherein the flexible tube has a length of between 0.2 and 3 meters.

### Claim 4 (depends on 1)

The system of claim 1, wherein the flexible tube has a length of between 1 and 2 meters.

### Claim 5 (depends on 1)

The system of claim 1, wherein the cannula is a deformable cannula.

### Claim 6 (depends on 1)

The system of claim 1, wherein the hydraulic actuator is a manual actuator.

### Claim 7 (depends on 1)

The system of claim 1, wherein the hydraulic actuator is an electric actuator.

### Claim 8 (depends on 7)

The system of claim 7, wherein the electric actuator includes a motor.

### Claim 9 (depends on 1)

The system of claim 1, wherein the cannula is removably connected to the reservoir.

### Claim 10 (depends on 1)

The system of claim 1, wherein the reservoir includes a piston for transforming hydraulic pressure into a motive force for driving delivery of the bone cement.

### Claim 11 (depends on 1)

The system of claim 1, wherein the working time is about 10 minutes.

### Claim 12 (depends on 1)

The system of claim 1, wherein, during the working time, the bone cement remains sufficiently flowable such that it can be delivered to the patient's vertebra.

### Claim 13 (depends on 1)

The system of claim 1, wherein the working time is at least 20 minutes.

### Claim 14 (depends on 1)

The system of claim 1, wherein the working time is at least 10 minutes.

### Claim 15

A system for delivering bone cement to a patient's vertebra, comprising:
a hydraulic actuator for generating a fluid pressure;
a reservoir having a quantity of bone cement contained therein, the bone cement comprising PMMA polymer and MMA monomer, the PMMA polymer having an average molecular weight and further containing a population of pre-polymerized PMMA beads having a high molecular weight, wherein the high molecular weight is greater than the average molecular weight and wherein the average molecular weight, the high molecular weight, and the percentage of beads having the high molecular weight are selected so that contacting the PMMA polymer and MMA monomer produces a mixture which has a stable high viscosity during a working time and solidifies after the working time;
a flexible tube connected to the hydraulic actuator and to the reservoir to transmit the fluid pressure from the hydraulic actuator to the reservoir; and
a cannula connected to the reservoir such that the fluid pressure from the hydraulic actuator forces bone cement from the reservoir through the cannula;
wherein the bone cement has a stable high viscosity of 200 to 2000 Pascal-second during a working time of at least 5 minutes, the stable viscosity changing by less than 20% during a period of 5 minutes and the bone cement solidifying after the working time; and
wherein the system is configured to deliver the bone cement to a patient's vertebra during the working time.

### Claim 16 (depends on 15)

The system of claim 15, wherein the hydraulic actuator is an electric actuator.

### Claim 17

A system for delivering bone cement to a patient's vertebra, comprising:
a hydraulic actuator for generating a fluid pressure;
a reservoir having a quantity of bone cement contained therein, the bone cement comprising PMMA polymer and MMA monomer, the PMMA polymer having an average molecular weight and further containing a population of pre-polymerized PMMA beads having a high molecular weight, wherein the high molecular weight is greater than the average molecular weight and wherein the average molecular weight, the high molecular weight, and the percentage of beads having the high molecular weight are selected so that contacting the PMMA polymer and MMA monomer produces a mixture which has a stable high viscosity during a working time and solidifies after the working time;
a flexible tube connected to the hydraulic actuator and to the reservoir to transmit the fluid pressure from the hydraulic actuator to the reservoir; and
a cannula connected to the reservoir such that the fluid pressure from the hydraulic actuator forces bone cement from the reservoir through the cannula;
wherein the bone cement has a stable high viscosity of 200 to 2000 Pascal-second during a working time of at least 5 minutes, the stable viscosity changing by less than 200 Pascal-seconds during a period of 2 minutes within the working time and the bone cement solidifying after the working time; and
wherein the system is configured to deliver the bone cement to a patient's vertebra during the working time.

### Claim 18 (depends on 17)

The system of claim 17, wherein the hydraulic actuator is an electric actuator.

### Claim 19 (depends on 17)

The system of claim 17, wherein the system is configured to generate a pressure of 50-300 atmospheres to force the bone cement out of the reservoir and into the patient's vertebra.

### Claim 20 (depends on 15)

The system of claim 15, wherein the system is configured to generate a pressure of 50-300 atmospheres to force the bone cement out of the reservoir and into the patient's vertebra.

### Claim 21 (depends on 1)

The system of claim 1, wherein the bone cement includes an initiator incorporated into the polymer and a chemical activator incorporated into the monomer.

### Claim 22 (depends on 21)

The system of claim 21, wherein the initiator comprises benzoyl peroxide and the chemical activator comprises DMPT.

### Claim 23 (depends on 21)

The system of claim 21, further comprising a hydroquinone added to the monomer to prevent spontaneous polymerization during storage.

### Claim 24 (depends on 15)

The system of claim 15, wherein the bone cement includes an initiator incorporated into the polymer, a chemical activator incorporated into the monomer, and a hydroquinone added to the monomer to prevent spontaneous polymerization during storage.

### Claim 25 (depends on 24)

The system of claim 24, wherein the initiator comprises benzoyl peroxide and the chemical activator comprises DMPT.

### Claim 26 (depends on 17)

The system of claim 17, wherein the bone cement includes an initiator incorporated into the polymer, a chemical activator incorporated into the monomer, and a hydroquinone added to the monomer to prevent spontaneous polymerization during storage.

### Claim 27 (depends on 26)

The system of claim 26, wherein the initiator comprises benzoyl peroxide and the chemical activator comprises DMPT.

### Claim 28 (depends on 23)

The system of claim 23, wherein the bone cement is radiopaque.

### Claim 29 (depends on 24)

The system of claim 24, wherein the bone cement is radiopaque.

### Claim 30 (depends on 26)

The system of claim 26, wherein the bone cement includes barium sulfate.

### Claim 31 (depends on 1)

The system of claim 1, wherein the viscosity is at least 500 Pascal-seconds during the working time.

### Claim 32 (depends on 15)

The system of claim 15, wherein the viscosity is at least 500 Pascal-seconds during the working time.

### Claim 33 (depends on 17)

The system of claim 17, wherein the viscosity is at least 500 Pascal-seconds during the working time.

### Claim 34 (depends on 15)

The system of claim 15, wherein the viscosity is at least 900 Pascal-seconds during the working time.

### Claim 35 (depends on 17)

The system of claim 17, wherein the viscosity is at least 900 Pascal-seconds during the working time.
