# US 8,540,722 B2 · Methods, materials and apparatus for treating bone and other tissue

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- Number: US 8,540,722 B2
- Document ID: US8540722B2
- Status: Granted
- Kind: B2
- Application number: 12/485,098
- Filed: 2009-06-16
- Published: 2009-10-22
- Granted: 2013-09-24
- Earliest claimed: 2003-06-17
- Assignees: DePuy Synthes Products, Inc.
- Applicants: Mordechay Beyar; Oren Globerman; Abraham Domb; Ronen Shavit; Hila Wachsler-Avrahami
- Inventors: Mordechay Beyar; Oren Globerman; Abraham Domb; Ronen Shavit; Hila Wachsler-Avrahami
- Web page: https://patentgrep.com/patent/US8540722B2

## CPC

- A61B 17/8852: {capable of being assembled or enlarged, or changing shape, inside the bone or disc}
- A61B 17/7095: {the filler comprising unlinked macroscopic particles}
- A61B 17/8805: {for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence)}
- 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 17/8833: {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}
- 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
- B01F 27/1143: screw-shaped, e.g. worms
- B01F 33/86: {Mixing heads comprising a driven stirrer}
- B01F 35/123: {using scrapers for cleaning mixers}
- B01F 35/531: {with baffles, plates or bars on the wall or the bottom}
- B01F 35/754251: {reciprocating in the mixing receptacle}
- A61B 17/8819: {characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula (A61B17/8825 takes precedence)}
- A61B 2017/00539: {hydraulically}
- A61B 2017/00734: {battery operated}
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs
- 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)
- B01F: MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING (mixing paints B44D3/06)

## Abstract

A method of treating a vertebra, comprising: (a) accessing an interior of a vertebra; and (b) introducing a sufficient amount of artificial biocompatible material which does not set to a hardened condition in storage, into said bone, with sufficient force to move apart fractured portions of said bone.

## Claims

### Claim 1

A method of treating a vertebra, comprising:
(a) inserting a delivery device into an interior of a vertebra;
(b) introducing bone cement through the delivery device and into the vertebra without an enclosure between the bone cement and the vertebra; and
(c) manipulating the delivery device, as the bone cement flows through the delivery device, to change an introduction direction of the bone cement;
wherein a sufficient amount of bone cement is delivered to the interior of the vertebra with sufficient force to move apart fractured portions of the vertebra.

### Claim 2 (depends on 1)

A method according to claim 1, wherein the bone cement sets to a hardened condition after introduction into the body.

### Claim 3 (depends on 1)

A method according to claim 1, wherein the bone cement does not set to a hardened condition in storage.

### Claim 4 (depends on 1)

A method according to claim 1, wherein the bone cement is a viscous fluid.

### Claim 5 (depends on 4)

A method according to claim 4, wherein the bone cement has a viscosity between 600 Pascal-second and 1,800 Pascal-second.

### Claim 6 (depends on 1)

A method according to claim 1, wherein introducing comprises introducing at a pressure of at least 40 atmospheres.

### Claim 7 (depends on 1)

A method according to claim 1, wherein introducing comprises introducing at a pressure of at least 100 atmospheres.

### Claim 8 (depends on 1)

A method according to claim 1, wherein the delivery device has a diameter of less than 6 mm and a length of at least 70 mm.

### Claim 9 (depends on 1)

A method according to claim 1, wherein the bone cement is introduced through an extrusion aperture formed in the delivery device and having a minimum dimension of less than 3 mm.

### Claim 10 (depends on 1)

A method according to claim 1, wherein the bone cement is introduced through an extrusion aperture formed in the delivery device and having a minimum dimension of less than 1.5 mm.

### Claim 11 (depends on 1)

A method according to claim 1, wherein introducing comprises introducing the bone cement through a plurality of extrusion apertures simultaneously, the plurality of extrusion apertures being formed in the delivery device.

### Claim 12 (depends on 1)

A method according to claim 1, further comprising manipulating the delivery device to change an introduction position of the bone cement.

### Claim 13 (depends on 1)

A method according to claim 1, wherein introducing comprises advancing the bone cement using a motor.

### Claim 14 (depends on 1)

A method according to claim 1, wherein introducing comprises advancing the bone cement using a hydraulic source.

### Claim 15 (depends on 1)

A method according to claim 1, wherein introducing comprises introducing the bone cement in discrete unit amounts.

### Claim 16 (depends on 15)

A method according to claim 15, wherein at least some of the units have different mechanical properties from each other.

### Claim 17 (depends on 1)

A method according to claim 1, wherein introducing comprises cutting the bone cement away from the delivery device.

### Claim 18 (depends on 1)

A method according to claim 1, wherein introducing comprises not twisting the delivery device during said introducing.

### Claim 19 (depends on 1)

A method according to claim 1, wherein introducing comprises shaping an extrusion form of the bone cement using an exit aperture formed in the delivery device.

### Claim 20 (depends on 1)

A method according to claim 1, wherein introducing comprises introducing without a separate void forming act.

### Claim 21 (depends on 1)

A method according to claim 1, wherein said introduced material is operative to support at least 30% of a weight of vertebra within a week after implantation.

### Claim 22

A method of treating bone, comprising:
(a) inserting a delivery device into an interior of a bone; and
(b) introducing bone cement into the bone through a plurality of extrusion apertures formed in the delivery device, without a separate void forming act and without an enclosure between the cement and the bone, and with sufficient force to move apart fractured portions of the bone.

### Claim 23 (depends on 22)

A method according to claim 22, comprising leaving the bone cement in said bone to resist at least 30% of a normative force which urges said portions together.

### Claim 24 (depends on 22)

A method according to claim 22, wherein said bone is a vertebra.

### Claim 25 (depends on 24)

A method according to claim 24, wherein the bone cement does not set to a hardened condition in storage.

### Claim 26 (depends on 22)

The method according to claim 22, wherein the delivery device comprises a cannula.

### Claim 27 (depends on 1)

The method according to claim 1, further comprising inserting a cannula into a body, and inserting the delivery device through the cannula prior to introducing the bone cement.

### Claim 28 (depends on 1)

The method according to claim 1, wherein manipulating the delivery device comprises rotating the delivery device as the bone cement flows into the vertebra.

### Claim 29 (depends on 1)

The method according to claim 1, further comprising removing the delivery device from a first access hole formed in the vertebra and inserting the delivery device through a second access hole formed in the vertebra.

### Claim 30 (depends on 29)

The method according to claim 29, further comprising introducing the bone cement while the delivery device is positioned in the second access hole.

### Claim 31 (depends on 1)

The method according to claim 1, further comprising inflating a balloon to create a cavity in the vertebra prior to inserting the delivery device into the vertebra.

### Claim 32 (depends on 22)

The method according to claim 22, further comprising manipulating the delivery device to change an introduction position of the bone cement.

### Claim 33 (depends on 32)

The method according to claim 32, wherein manipulating comprises moving the delivery device axially to direct the bone cement to a desired location in the bone.

### Claim 34 (depends on 12)

The method according to claim 12, wherein manipulating comprises moving the delivery device axially to direct the bone cement to a desired location in the vertebra.

### Claim 35

A method of treating a vertebra, comprising:
(a) inserting a delivery device into an interior of a vertebra; and
(b) introducing bone cement through the delivery device and into the vertebra without a separate void forming act and without an enclosure between the bone cement and the vertebra;
wherein a sufficient amount of bone cement is delivered to the interior of the vertebra with sufficient force to move apart fractured portions of the vertebra.

### Claim 36 (depends on 35)

The method according to claim 35, wherein manipulating the delivery device comprises rotating the delivery device as the bone cement flows into the vertebra.

### Claim 37 (depends on 35)

The method according to claim 35, wherein manipulating comprises moving the delivery device axially to direct the bone cement to a desired location in the bone.

### Claim 38 (depends on 35)

The method according to claim 35, wherein introducing comprises advancing the bone cement using a motor.

### Claim 39 (depends on 35)

The method according to claim 35, wherein introducing comprises advancing the bone cement using a hydraulic source.

### Claim 40 (depends on 35)

The method according to claim 35, wherein the bone cement is a viscous fluid.

### Claim 41 (depends on 35)

The method according to claim 35, wherein the bone cement has a viscosity between 600 Pascal-second and 1,800 Pascal-second.

### Claim 42 (depends on 35)

The method according to claim 35, wherein introducing comprises introducing at a pressure of at least 40 atmospheres.

### Claim 43 (depends on 35)

The method according to claim 35, wherein introducing comprises introducing at a pressure of at least 100 atmospheres.

### Claim 44 (depends on 35)

The method according to claim 35, wherein introducing comprises introducing the bone cement through at least one extrusion aperture formed in a sidewall of the delivery device.
