# US 8,540,123 B2 · Apparatus and method for mixing and dispensing a bone cement mixture

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- Number: US 8,540,123 B2
- Document ID: US8540123B2
- Status: Granted
- Kind: B2
- Application number: 13/493,015
- Filed: 2012-06-11
- Published: 2012-09-27
- Granted: 2013-09-24
- Earliest claimed: 2007-12-27
- Assignees: Cook Medical Technologies LLC
- Applicants: Jeffry S. Melsheimer; Jonathan Lee Bennett; Jessica L. Burke
- Inventors: Jeffry S. Melsheimer; Jonathan Lee Bennett; Jessica L. Burke
- Web page: https://patentgrep.com/patent/US8540123B2

## CPC

- B01F 35/713: {comprising breaking packages or parts thereof, e.g. piercing or opening sealing elements between compartments or cartridges (containers or packages per se B65D)}
- A61B 17/7097: {Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants (disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444)}
- B01F 27/91: with propellers
- B01F 33/50111: {Small portable bottles, flasks, vials, e.g. with means for mixing ingredients or for homogenizing their content, e.g. by hand shaking}
- B01F 35/213: of the properties of the mixtures, e.g. temperature, density or colour
- B01F 35/32: Driving arrangements
- B01F 35/7131: {Breaking or perforating packages, containers or vials}
- B01F 35/7162: {A container being placed inside the other before contacting the contents}
- B01F 35/754251: {reciprocating in the mixing receptacle}
- A61B 17/8827: {with filtering, degassing, venting or pressure relief means}
- A61B 2017/8838: {for mixing bone cement or fluid fillers}
- B01F 35/3202: {Hand driven}
- B01F 2101/20: Mixing of ingredients for bone cement
- B01F: MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING (mixing paints B44D3/06)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Among other things, an apparatus for mixing and dispensing a bone cement mixture are provided. In certain embodiments, the apparatus includes a housing having a first chamber for containing an ampoule having a first bone cement component. The housing has a second chamber for containing a second bone cement component and the first and second chambers are in fluid communication. An ampoule breaking device is disposed within the first chamber and is configured to engage and break the ampoule for release of the first bone cement component. Disposed within the second chamber is an impeller that is configured to rotate such that the impeller mixes the first and second bone cement components together to form the bone cement mixture. Adjacent the impeller is a displacer that is configured to advance through the second chamber, receiving the impeller and dispensing the bone cement mixture.

## Claims

### Claim 1

A method for mixing a bone cement mixture and dispensing the bone cement mixture into a damaged bone of a patient, the method comprising:
releasing a first bone cement component from an ampoule into a first chamber of an apparatus, including breaking the ampoule within the first chamber with an ampoule breaking device at least partially disposed within the first chamber, wherein the apparatus includes a second chamber in fluid communication with the first chamber, with an impeller disposed within the second chamber and a displacer disposed adjacent to the impeller;
advancing the first bone cement component from the first chamber to the second chamber containing a second bone cement component;
mixing the first and second bone cement components together by rotating the impeller to form the bone cement mixture;
inserting a needle into the damaged bone of the patient, the needle being in fluid communication with the outlet;
dispensing the bone cement mixture from the apparatus into the damaged bone of the patient via the needle including advancing the displacer through the second chamber, wherein the displacer receives the impeller and advances the bone cement mixture from the second chamber through an outlet in fluid communication with the second chamber; and
curing the bone cement mixture to stabilize the damaged bone of the patient.

### Claim 2 (depends on 1)

The method according to claim 1, further comprising filtering the first bone cement component released into the first chamber with a filter in fluid communication with the first and second chambers, the filter receiving pieces of the broken ampoule.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the apparatus further includes a plurality of crank arms configured to be actuated, providing rotational driving force to the impeller and the step of mixing the first and second bone cement component includes actuating the crank arms.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the first chamber is formed in a first portion of a housing and the second chamber is formed in a second portion of the housing, the first portion being configured to move relative to the second portion and slidingly engaging the displacer, and wherein the apparatus further includes a handle disposed about the first portion, the handle and the first portion each having at least one flange, the flange of the handle engaging the flange of the first portion, and the step of dispensing the bone cement mixture includes actuating the handle, cooperating the flange of the handle with the flange of the first portion to advance the first portion towards the displacer such that the displacer is advanced in the second chamber.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the ampoule breaking device includes a rotating member and a cord member, the rotating member disposed within the first chamber and engaging a portion of the ampoule, the cord member having a first end for actuation and a second end operably connected to the rotating member to rotate the rotating member during actuation of the first end, and the step of releasing the first bone cement component further includes actuating the first end, rotating the rotating member causing the ampoule to break.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the ampoule breaking device has a surface formed at an incline to a longitudinal axis of the first chamber and the ampoule breaking device includes a wedge member disposed within the first chamber and a manually-activated element communicating with the wedge member such that the wedge member moves the ampoule against the inclined surface when the manually- activated element is actuated, and the step of breaking the ampoule includes actuating the manually-activated control element, moving the ampoule against the inclined surface causing the ampoule to break.

### Claim 7

A method for mixing a bone cement mixture for use with a damaged bone of a patient, the method comprising:
advancing a first bone cement component from a first chamber of an apparatus to a second chamber of the apparatus containing a second bone cement component, the apparatus having an impeller disposed within the second chamber and a displacer that receives the impeller and is adapted to advance with respect to the impeller through the second chamber; and
mixing the first and second bone cement components together by rotating the impeller and displacer cooperatively to form the bone cement mixture.

### Claim 8 (depends on 7)

The method of claim 7, further comprising releasing the first bone cement component from an ampoule into the first chamber of an apparatus, including breaking the ampoule within or adjoining the first chamber with an ampoule breaking device at least partially disposed within the first chamber.

### Claim 9 (depends on 8)

The method of claim 8, wherein the ampoule breaking device includes a rotating member adapted to engage a part of the ampoule, and the breaking includes rotating the rotating member.

### Claim 10 (depends on 9)

The method of claim 9, wherein the rotating member includes a lumen for accommodating the part of the ampoule.

### Claim 11 (depends on 9)

The method of claim 9, wherein the breaking includes separating a head part from the rest of the ampoule, and wherein the rotating member turns sufficiently so that the head part can empty into one or both of the chambers.

### Claim 12 (depends on 8)

The method of claim 8, wherein the ampoule breaking device includes a wedge member at least partially within the first chamber, and the breaking includes moving the wedge member substantially longitudinally in the first chamber.

### Claim 13 (depends on 8)

The method of claim 8, wherein the ampoule breaking device includes an inclined surface within the first chamber, and the breaking includes moving the ampoule against the inclined surface.

### Claim 14 (depends on 7)

The method of claim 7, further comprising:
inserting a needle into the damaged bone of the patient, the needle being in fluid communication with an outlet in fluid communication with the second chamber; and
dispensing the bone cement mixture from the apparatus into the damaged bone of the patient via the needle.

### Claim 15 (depends on 14)

The method of claim 14, wherein the dispensing includes advancing the displacer through the second chamber along at least part of the impeller to advance the bone cement mixture from the second chamber through an outlet in the second chamber.

### Claim 16 (depends on 15)

The method of claim 15, further comprising curing the bone cement mixture to stabilize the damaged bone of the patient.

### Claim 17 (depends on 7)

The method of claim 7, wherein the impeller and displacer are configured to rotate cooperatively at least during the mixing.

### Claim 18 (depends on 7)

The method of claim 7, wherein a valve is between the first and second chambers, and the advancing includes opening the valve.

### Claim 19 (depends on 18)

The method of claim 18, wherein the valve is part of an ampoule breaking device, and wherein breaking an ampoule within the first chamber at least partially opens the valve.

### Claim 20 (depends on 18)

The method of claim 18, wherein the opening includes rotating the valve around one of a longitudinal axis of the first chamber and a transverse axis of the first chamber.

### Claim 21 (depends on 7)

The method of claim 7, further comprising closing a valve between the first and second chambers prior to the mixing.

### Claim 22 (depends on 7)

The method of claim 7, further comprising dispensing the bone cement mixture into a balloon.

### Claim 23 (depends on 22)

The method of claim 22, further comprising placing the balloon in a patient prior to the dispensing.

### Claim 24 (depends on 23)

The method of claim 23, further comprising sealing the balloon.

### Claim 25 (depends on 24)

The method of claim 24, wherein the dispensing occurs via a needle, and the sealing includes least one of (a) twisting the needle, (b) shearing the corresponding end portion of the balloon, and (c) applying an adhesive to the corresponding end portion of the balloon.

### Claim 26 (depends on 7)

The method of claim 7, further comprising de-gassing the bone cement mixture during or following the mixing.