# US 2014/0192611 A1 · Bone cement mixing and delivery system with reduced fume exposure

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- Number: US 2014/0192611 A1
- Document ID: US20140192611A1
- Status: Published application
- Kind: A1
- Application number: 13/735,608
- Filed: 2013-01-07
- Published: 2014-07-10
- Earliest claimed: 2013-01-07
- Assignees: Kyphon SARL
- Applicants: Kyphon Sarl
- Inventors: NEIL S. SASAKI; Bryan A. Click
- Web page: https://patentgrep.com/patent/US20140192611A1

## CPC

- B01F 35/7137: {Piercing, perforating or melting membranes or closures which seal the compartments}
- 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}
- B01F 35/189: {Venting, degassing or ventilating of gases, fumes or toxic vapours during mixing}
- B01F 35/7131: {Breaking or perforating packages, containers or vials}
- B01F 35/7174: {using pistons, plungers or syringes}
- B01F 35/718: {using vacuum, under pressure in a closed receptacle or circuit system}
- A61B 2017/8838: {for mixing bone cement or fluid fillers}
- 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

A system for bone cement includes a vial holder configured for receiving a vial and including a holding structure for maintaining the vial in the vial holder. The vial includes a monomer component for bone cement. A holder chamber is configured to receive and secure the vial holder. The vial holder is advanced toward a vial-breaking device for breaking the vial and releasing its contents into the holder chamber past the elastomeric seal. Once the vial holder is advanced further the elastomeric seal is deformed to form a seal and prevent fumes produced from escaping from the device.

## Claims

### Claim 1

A device for mixing and containing fumes for a bone cement component comprising:
a vial holder configured for receiving and holding a vial therein;
a holder chamber configured to receive and secure the vial holder therein when engaged with the vial holder, the vial holder and the holder chamber forming an enclosure for containing the vial;
a vial-breaking device disposed in the holder chamber, the vial holder being configured to be advanced toward the vial-breaking device for breaking the vial and for releasing contents of the vial into the holder chamber;
a filter disposed within the holder chamber; and
an elastomeric seal positioned about the vial-breaking device having a first surface and an opposite second surface, the first surface positioned so as to contact a surface of the vial holder and the second surface positioned to contact a surface of the holder chamber whereby advancement of the vial holder deforms the elastomeric seal from a first diameter that is smaller than the diameter of the holder chamber to a second diameter that is larger than the first diameter and forms a seal against an inside wall of the holder chamber so as to prevent fumes from escaping from the holder chamber.

### Claim 2 (depends on 1)

A device as recited in claim 1 further comprising a port in communication with the holder chamber through the filter such that when a vacuum is drawn at the port by a dispensing device the contents of the vial are drawn through the filter and into the dispensing device such that fumes are contained in the enclosure and the dispensing device.

### Claim 3 (depends on 1)

A device as recited in claim 1, wherein the vial holder is threadedly received in the holder chamber and the vial holder is advanced against the vial-breaking device by turning the vial holder.

### Claim 4 (depends on 1)

A device as recited in claim 1, further comprising a one-way valve disposed between the holder chamber and the port to prevent back flow into the holder chamber.

### Claim 5 (depends on 1)

A device as recited in claim 1, wherein the dispensing device includes a syringe configured to provide a sealed connection to the port and a vacuum by pulling a plunger of the syringe out of the syringe.

### Claim 6 (depends on 1)

A device as recited in claim 1, wherein the port includes a Luer-lock fitting.

### Claim 7 (depends on 2)

A device as recited in claim 2, wherein the holder chamber and the port are disposed in a base assembly and the port connects to the dispensing device such that the dispersing device is parallel to an advancing direction of the vial holder.

### Claim 8 (depends on 7)

A device as recited in claim 7, wherein the holder chamber and the port are connected by a lumen disposed in line with the advancing direction of the vial holder

### Claim 9 (depends on 2)

A device as recited in claim 2, wherein when the dispensing device is docked with the port, the dispensing device is disposed transversely to an advancing direction of the vial holder.

### Claim 10 (depends on 1)

A device as recited in claim 1, wherein the vial-breaking device includes a spike or needle.

### Claim 11 (depends on 10)

A device as recited in claim 10, further comprising a vial securely held in the vial holder, the vial holder having an opening to expose a surface of the vial to the vial-breaking device when installed on the holder chamber.

### Claim 12 (depends on 11)

A device as recited in claim 11, wherein the vial includes a monomer component for bone cement.

### Claim 13 (depends on 1)

A device as recited in claim 1, further comprising a mixing chamber including a port for receiving the dispensing device and permitting dispensing of the contents of the dispensing device through a wall of the mixing chamber such that fumes are contained in the mixing chamber and the dispensing device.

### Claim 14 (depends on 13)

A device for as recited in claim 13, wherein the contents of the dispensing device include a liquid monomer component of bone cement and the mixing chamber includes a powder component of the bone cement.

### Claim 15 (depends on 13)

A device as recited in claim 13, wherein the port for receiving the dispensing device includes a Luer-lock fitting.

### Claim 16 (depends on 13)

A device as recited in claim 13, wherein the port for receiving the dispensing device includes a sealable membrane and the dispensing device includes a needle injectable through the membrane.

### Claim 17 (depends on 1)

A device as recited in claim 1, wherein the system is disposable.

### Claim 18

A system for containing fumes for a bone cement component comprising:
a vial holder configured for receiving a vial therein and including a holding structure for maintaining the vial in the vial holder, the vial holder having an opening to expose a surface of a vial, the vial including a monomer component for bone cement;
a holder chamber configured to receive and secure the vial holder, the vial holder being threadedly received in the holder chamber and advanced in an advance direction by employing threads, the vial holder and the holder chamber forming an enclosure for containing the vial;
a vial-breaking device disposed in the holder chamber, the vial holder being configured to be advanced toward the vial-breaking device for engaging the surface of the vial, breaking the vial and releasing contents of the vial into the holder chamber;
an elastomeric seal positioned about the vial-breaking device, the elastomeric seal having a first surface and an opposite second surface, the first surface of the elastomeric seal positioned so as to contact a surface of the vial holder and the second surface of the elastomeric seal positioned to contact a surface of the holder chamber so that advancement of the vial holder compresses the elastomeric seal against the surface of the vial holder so as to change the diameter of the elastomeric seal from a first diameter that is smaller than the diameter of the holder chamber to a second diameter that is larger than the first diameter to form a seal against an inside wall of the holder chamber and prevent fumes from escaping from the holder chamber;
a filter in contact with the holder chamber;
a port in communication with the holder chamber through the filter;
a one way valve disposed between the holder chamber and a port to prevent back flow into the holder chamber; and
a dispensing device is connectable to the port for drawing a vacuum at the port to draw the contents of the vial through the filter and into the dispensing device such that fumes are contained in the enclosure and the dispensing device.

### Claim 19 (depends on 18)

A method for containing fumes of a bone cement component, the method comprising the steps of:
providing a system of claim 18 including a vial holder configured for receiving and holding a vial therein; a holder chamber configured to receive and secure the vial holder therein such that when engaged with the vial holder, the vial holder and the holder chamber form an enclosure for containing the vial; a vial breaking device disposed in the holder chamber, the vial holder being configured to advance toward the vial breaking device for breaking the vial and for releasing contents of the vial into the holder chamber; an elastomeric seal positioned in the vial chamber; a filter disposed within the holder chamber; and a port in communication with the holder chamber through the filter;
providing a vial of a monomer component of bone cement in the vial holder;
advancing the vial holder in the holder chamber to break the vial against the vial breaking device and further advancing the vial holder to contact the elastomeric seal and deform the elastomeric seal so as to form a seal against an inside surface of the holder chamber; and
drawing a vacuum at the port by a dispensing device to draw the contents of the vial through the filter and into the dispensing device such that fumes are contained in the enclosure and the dispensing device.

### Claim 20 (depends on 19)

A method for containing fumes of a bone cement component as recited in claim 19 wherein the monomer component is liquid and drips into a powder component of the bone cement to form the bone cement.
