# US 10,307,508 B2 · Vacuum mixing system and method for the mixing of polymethylmethacrylate bone cement

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- Number: US 10,307,508 B2
- Document ID: US10307508B2
- Status: Granted
- Kind: B2
- Application number: 14/755,137
- Filed: 2015-06-30
- Published: 2016-01-21
- Granted: 2019-06-04
- Earliest claimed: 2014-07-15
- Assignees: Heraeus Medical GmbH
- Applicants: Heraeus Medical GmbH
- Inventors: Sebastian Vogt
- Web page: https://patentgrep.com/patent/US10307508B2

## CPC

- A61B 17/8825: {characterised by syringe details (A61B17/8822, A61B17/8827 take precedence)}
- A61L 24/06: obtained by reactions only involving carbon-to-carbon unsaturated bonds {(A61L24/043, A61L24/046 take precedence)}
- A61B 17/8827: {with filtering, degassing, venting or pressure relief means}
- B01F 31/40: with an axially oscillating rotary stirrer
- B01F 31/441: performing a rectilinear reciprocating movement
- B01F 33/50112: {of the syringe or cartridge type}
- B01F 33/70: Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming
- B01F 35/146: {Working under sterile conditions; Sterilizing the mixer or parts thereof}
- B01F 35/75425: {using pistons or plungers}
- B01F 35/754251: {reciprocating in the mixing receptacle}
- B29B 7/24: for feeding
- A61B 2017/8838: {for mixing bone cement or fluid fillers}
- B01F 2101/20: Mixing of ingredients for bone cement
- B29K 2033/12: {Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate}
- 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)
- B29B: PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS

## Abstract

A vacuum mixing system for the mixing of polymethylmethacrylate bone cement comprising at least one cartridge (4) having an evacuatable internal space (5) for the mixing of the bone cement, the internal space (5) of which comprises a cylindrical swept volume, a mixing element (12) that is arranged in the internal space (5) of the cartridge (4) such as to be mobile and can be operated from outside the vacuum mixing system in order to mix the content in the internal space (5) of the cartridge (4), and a dispensing plunger (2) having a cylindrical external circumference whose first base surface borders a base surface of the internal space (5) of the cartridge (4) and which can be or is locked to the cartridge (4) in detachable manner and which, in the detached state, is mobile in the cylindrical region of the internal space (5) of the cartridge (4).

## Claims

### Claim 1

Vacuum mixing system for the mixing of polymethylmethacrylate bone cement, comprising
at least one cartridge (4, 104) having an evacuatable internal space (5, 105) for the mixing of the bone cement, whereby the internal space (5, 105) comprises a cylindrical swept volume defined by a cylindrical cartridge wall,
a mixing element (12, 112) that is arranged in the internal space (5, 105) of the cartridge (4, 104) such as to be mobile and can be operated from outside the vacuum mixing system in order to mix the content in the internal space (5, 105) of the cartridge (4, 104), and
a dispensing plunger (2, 102) having a cylindrical external circumference defining a jacket surface and a first base surface bordering a base surface of the internal space (5, 105) of the cartridge (4, 104) and which can be or is locked to the cartridge (4, 104) in detachable manner and which, in the detached state, is mobile in the cylindrical region of the internal space (5, 105) of the cartridge (4, 104),
whereby a gas-permeable and particle-impermeable feedthrough (1, 101) is arranged in the dispensing plunger (2, 102) and said feedthrough (1, 101) is further formed between the dispensing plunger (2, 102) and the internal wall of the internal space (5, 105), whereby the feedthrough (1, 101) extends from an opening in the jacket surface of the dispensing plunger (2, 102) to an opening in the first base surface of the dispensing plunger (2, 102).

### Claim 2 (depends on 1)

Vacuum mixing system according to claim 1, wherein
the dispensing plunger (2, 102) comprises at least one circumferential seal (20, 120) that seals the internal space (5, 105) of the cartridge (4, 104) with respect to the outside, optionally having at least one circumferential seal (20, 120) arranged between a second base surface of the dispensing plunger (2, 102), which is situated opposite from the first base surface of dispensing plunger (2, 102), and the opening in the jacket surface of the dispensing plunger (2, 102).

### Claim 3 (depends on 1)

Vacuum mixing system according to claim 1, wherein the cartridge wall of the cartridge (4, 104) comprises an opening (143), which overlaps with the opening in the jacket surface of the dispensing plunger (2, 102) while the dispensing plunger (2, 102) is in an opened position, and by means of which the internal space (5, 105) is or can be connected in gas-permeable manner to the surroundings of the vacuum mixing system.

### Claim 4 (depends on 3)

Vacuum mixing system according to claim 3, wherein
a closure element (144) is arranged on the external wall of the cartridge (4, 104) by means of which the opening (143) in the wall of the cartridge (4, 104) can be closed, optionally a closure element (144) arranged on the external wall of the cartridge (4, 104) that can be shifted in axial direction of the cartridge (4, 104).

### Claim 5 (depends on 4)

Vacuum mixing system according to claim 4, wherein
the closure element (144) is a circumferential cuff (144) that touches, to fit, against the external wall of the cartridge (4, 104) and can be shifted in axial direction of the cartridge (4, 104) in order to cover and thus close the opening (143) in the wall of the cartridge (4, 104), whereby, optionally, at least one handle part (146) is fastened on the cuff (144) and is provided for manual shifting of the cuff (144) on the external wall of the cartridge (4, 104).

### Claim 6 (depends on 1)

Vacuum mixing system according to claim 1, wherein
the dispensing plunger (2, 102), in a first lockable position, projects from the cartridge (4, 104) such that the opening in the jacket surface of the dispensing plunger (2, 102) is open, and in that the dispensing plunger (2, 102), in a second lockable position, is arranged deeper in the internal space (5, 105) of the cartridge (4, 104) such that the opening in the jacket surface of the dispensing plunger (2, 102) is closed by the internal wall of the cartridge (4, 104).

### Claim 7 (depends on 6)

Vacuum mixing system according to claim 6, wherein
a circumferential sealing element (20, 120) is arranged between the opening in the jacket surface of the dispensing plunger (2, 102) and the second base surface of the dispensing plunger (2, 102), which is situated opposite from the first base surface of the dispensing plunger (2, 102).

### Claim 8 (depends on 1)

Vacuum mixing system according to claim 1, wherein a gas-permeable particle filter (22, 122) is arranged in the feedthrough (1, 101) and/or at the opening to the feedthrough (1, 101) in the jacket surface of the dispensing plunger (2, 102) and/or at the opening to the feedthrough (1, 101) in the first base surface of the dispensing plunger (2, 102), whereby the gas-permeable particle filter (22, 122) is impermeable for particles having a diameter of more than 1 μm.

### Claim 9 (depends on 1)

Vacuum mixing system according to claim 1, wherein
the dispensing plunger (2, 102) is gas-tight on its side that points from the interior of the cartridge (4, 104), except for a vacuum feedthrough (36, 136).

### Claim 10 (depends on 1)

Vacuum mixing system according to claim 1, wherein
the dispensing plunger (2, 102) comprises, on the first base surface, a gas-permeable pore disk (22, 122) that is supported by ribbing.

### Claim 11 (depends on 1)

Vacuum mixing system according to claim 1, wherein
the dispensing plunger (2, 102) can be pushed axially into the cartridge (4, 104) in order to dispense a bone cement dough, that has been mixed from a bone cement powder and a monomer liquid, through a dispensing opening on an end of the cartridge (4, 104) opposite from the dispensing plunger (2, 102), whereby the dispensing plunger (2, 102) optionally can be pushed axially into the cartridge (4, 104) after detaching a locking mechanism.

### Claim 12 (depends on 1)

Vacuum mixing system according to claim 1, wherein
a dispensing opening of the cartridge (4, 104) comprises a connecting thread (8, 108).

### Claim 13 (depends on 1)

Vacuum mixing system according to claim 1, wherein
the mixing element (12, 112) is arranged on a rod (10, 110) that is guided through a gas-tight passage into the interior of the cartridge (4, 104), and the mixing element (12, 112) is mobile by pushing it in and out of the cartridge (4, 104) and by rotating it in the cartridge (4, 104), whereby the rod (10, 110) optionally comprises a predetermined breakage site at which the rod (10, 110) can be broken off near the passage once it has been pulled out of the cartridge (4, 104).

### Claim 14 (depends on 1)

Vacuum mixing system according to claim 1, wherein
the vacuum mixing system comprises a glass container for monomer liquid, and the cartridge (4, 104) contains a cement powder, whereby an opening element for opening of the reservoir container is provided, and the cartridge (4, 104) is or can be connected via a conduit to the opened reservoir container.

### Claim 15 (depends on 14)

Vacuum mixing system according to claim 14, wherein
the vacuum mixing system comprises a base element, whereby the base element stores the cartridge (4, 104), the reservoir container, and the opening element.

### Claim 16 (depends on 15)

Vacuum mixing system according to claim 15, wherein
the base element comprises a coupling means for a non-positive fit- and/or positive fit-like connection to the connecting means (8, 108) on the dispensing opening of the cartridge (4, 104).

### Claim 17 (depends on 14)

Vacuum mixing system according to claim 14, wherein
a valve element controlling and/or triggering the outflow of the monomer liquid from the reservoir container into the cartridge (4, 104) is arranged in the conduit.

### Claim 18 (depends on 14)

Vacuum mixing system according to claim 14, wherein
a snap-in means (38, 138) is provided on the cartridge (4, 104) and at least one opposite snap-in means (40, 42, 140) is provided on the dispensing plunger (2, 102), whereby the dispensing plunger (2, 102) is detachably locked to the snap-in means (38, 138) in the cartridge (4, 104) in one position or is detachably locked in at least two positions, whereby the feedthrough (1, 101) is opened in a first locked position and is closed in gas-tight manner in a second locked position.
