# US 2018/0021075 A1 · Bone cement applicator with three-way valve for pressure relief

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- Number: US 2018/0021075 A1
- Document ID: US20180021075A1
- Status: Published application
- Kind: A1
- Application number: 15/656,369
- Filed: 2017-07-21
- Published: 2018-01-25
- Earliest claimed: 2016-07-21
- Assignees: Heraeus Medical GmbH
- Applicants: Heraeus Medical GmbH
- Inventors: Sebastian VOGT; Thomas KLUGE
- Web page: https://patentgrep.com/patent/US20180021075A1

## CPC

- 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 17/7095: {the filler comprising unlinked macroscopic particles}
- A61B 17/8816: {characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections}
- A61B 17/8825: {characterised by syringe details (A61B17/8822, A61B17/8827 take precedence)}
- A61B 17/8827: {with filtering, degassing, venting or pressure relief means}
- 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 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- B01F 23/47: involving high-viscosity liquids, e.g. asphalt
- B01F 25/42: in which the mixing is affected by moving the components jointly in changing directions, e.g. in tubes provided with baffles or obstructions
- B01F 25/43141: {composed of consecutive sections of helical formed elements}
- B01F 33/50112: {of the syringe or cartridge type}
- B01F 33/81: Combinations of similar mixers, e.g. with rotary stirring devices in two or more receptacles
- B01F 35/522: {comprising compartments keeping the materials to be mixed separated until the mixing is initiated (containers or packages for packaging two or more different materials which must be maintained separate prior to use in admixture B65D81/32)}
- B01F 35/602: {with a safety or relief valve}
- B01F 35/7162: {A container being placed inside the other before contacting the contents}
- B01F 35/7174: {using pistons, plungers or syringes}
- B01F 35/7547: {using valves, gates, orifices or openings}
- B05C 17/00553: {with means allowing the stock of material to consist of at least two different components}
- B05C 17/00576: {characterised by the construction of a piston as pressure exerting means, or of the co-operating container}
- B05C 17/00583: {the container for the material to be dispensed being deformable}
- B05C 17/0106: {with means for longitudinally cutting container walls during relative displacement of the piston and its cooperating container}
- B65D 81/325: {Containers having parallel or coaxial compartments, provided with a piston or a movable bottom for discharging contents}
- B65D 83/76: for dispensing fluent contents by means of a piston
- B65D 83/7713: {the contents of a flexible bag being expelled by a piston, or a movable bottom or partition provided in the container or the package}
- A61B 2017/8838: {for mixing bone cement or fluid fillers}
- 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)
- B05C: APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (spraying apparatus, atomising apparatus, nozzles B05B; plant for applying liquids or other fluent materials to objects by electrostatic spraying B05B5/08)
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

Bone cement applicators and methods apply a bone cement dough in the region of the spine. The applicators and method have at least one tubular cartridge with an internal space, containing starting components of the bone cement, at least one dispensing plunger that is mobile in longitudinal direction on the inside of the at least one cartridge, a hose, an application opening through which the bone cement dough is applicable, a three-way valve being arranged in the hose or on a side of the hose facing the at least one cartridge and in fluid connection with the opening of the at least one cartridge and/or a collecting container arranged on the three-way valve for accommodation of bone cement dough. The three-way valve is appropriately designed and/or arranged in the bone cement applicator such that it, being in a first position, provides a fluid connection between the application opening and the opening of the at least one cartridge and closes a passage to the collecting container and, being in a second position, provides a fluid connection between the application opening and the collecting container and closes a passage to the opening of the at least one cartridge.

## Claims

### Claim 1

A bone cement applicator comprising:
at least one tubular cartridge with an internal space, wherein the internal space is configured to contain starting components of a bone cement;
at least one dispensing plunger configured for expelling the starting components from the at least one cartridge through an opening of the at least one cartridge, wherein the at least one dispensing plunger is mobile in longitudinal direction on the inside of the at least one cartridge;
a hose;
so an application opening through which the bone cement dough is applicable;
a three-way valve being operable from outside and being arranged in the hose or on a side of the hose facing the at least one cartridge, wherein the three-way valve is in fluid connection with the opening of the at least one cartridge; and
a collecting container arranged on the three-way valve for accommodation of bone cement dough;
wherein the three-way valve is appropriately designed and is appropriately arranged in the bone cement applicator such that it,
being in a first position, provides a fluid connection between the application opening and the opening of the at least one cartridge and closes a feed-through to the collecting container and,
being in a second position, provides a fluid connection between the application opening and the collecting container and closes a passage to the opening of the at least one cartridge.

### Claim 2 (depends on 1)

The bone cement applicator according to claim 1, further comprising:
a mixer is arranged between the opening of the at least one cartridge and the hose or between the opening of the at least one cartridge and the three-way valve, wherein the three-way valve is arranged between the mixer and the hose, wherein the three-way valve, being in the first position, provides a fluid connection between the application opening and the mixer and, being in the second position, closes the passage to the mixer.

### Claim 3 (depends on 1)

The bone cement applicator according to claim 1, wherein the bone cement applicator is operable by means of a manually operated extrusion device and in that the at least one dispensing plunger is movable in the at least one cartridge by manual force, wherein the cross-section of the internal space of the one cartridge is maximally 3.5 cm2 or the cross-section of all internal spaces of the cartridges taken together is maximally 3.5 cm2 and/or that the propulsion area of the at least one dispensing plunger is maximally 3.5 cm2.

### Claim 4 (depends on 1)

The bone cement applicator according to claim 1, wherein at least part of the hose is flexible and/or the application opening is arranged in a connection with an internal thread, in a Luer system adapter, or in a trocar.

### Claim 5 (depends on 1)

The bone cement applicator according to claim 1, wherein the collecting container is impermeable for the bone cement dough towards the outside, the collecting container is fluid-tight or fluid-tight and gas-tight, and/or the collecting container has a volume that is at least as large as half the volume of the hose.

### Claim 6 (depends on 1)

The bone cement applicator according to claim 1, wherein the at least one cartridge comprises, on its rear side, an attachment element for attachment of an extrusion device.

### Claim 7 (depends on 1)

The bone cement applicator according to claim 1, further comprising:
a first tubular cartridge with a first cylindrical internal space, wherein a first starting component of a bone cement is contained in the internal space;
a first dispensing plunger that is arranged in the first internal space of the first cartridge such as to be axially mobile and that is provided for expelling the first starting component from the first cartridge through an opening in a cartridge head of the first cartridge that is situated opposite from the first dispensing plunger; and
a second tubular cartridge that is arranged inside the first tubular cartridge, wherein the second cartridge contains a second starting component of the bone cement and has a second dispensing plunger arranged in it, wherein the second dispensing plunger is usable to expel the second starting component from the second cartridge through an opposite opening of the second cartridge in the region of the cartridge head of the first cartridge,
wherein a pressing device is arranged in the internal space of the first cartridge behind the first dispensing plunger and the second dispensing plunger, as seen from the cartridge head, the pressing device comprising a clamping edge for compressing the second cartridge and being propellable axially, whereby the pressing device is propellable appropriately in the direction of the cartridge head such that the second cartridge is being progressively compressed axially during the motion of the pressing device thereby propelling the first dispensing plunger and the second dispensing plunger in the direction of the cartridge head.

### Claim 8 (depends on 7)

The bone cement applicator according to claim 7, wherein the external wall of the second cartridge touches against the internal wall of the first cartridge and is attached to the internal wall of the first cartridge.

### Claim 9 (depends on 7)

The bone cement applicator according to claim 7, wherein the first dispensing plunger and the second dispensing plunger are propelled parallel with respect to each other during the propulsion of the pressing device.

### Claim 10 (depends on 7)

The bone cement applicator according to claim 7, wherein the clamping edge is inclined at an angle of at least 40° perpendicular to the longitudinal axis in the direction of the internal wall of the first cartridge.

### Claim 11 (depends on 7)

The bone cement applicator according to claim 7, wherein a gap is provided between the pressing device and the internal wall of the first cartridge in the region of the second cartridge, whereby the gap is as wide as or wider than the thickness of the wall of the second cartridge.

### Claim 12 (depends on 7)

A bone cement applicator according to claim 7, characterised in that the clamping edge, by squeezing the second cartridge, presses the thus deformed wall of the second cartridge against the underside of the second dispensing plunger and thus pushes the second dispensing plunger in the direction of the cartridge head while the pressing device is being propelled in the direction of the cartridge head.

### Claim 13 (depends on 7)

The bone cement applicator according to claim 7, further comprising:
a third tubular cartridge arranged inside the first tubular cartridge, wherein the external wall of the third cartridge touches against the internal wall of the first cartridge and is attached to the internal wall of the first cartridge, whereby the third cartridge contains the second starting component or a third starting component of the multicomponent bone cement and has a third so dispensing plunger arranged in it, wherein the second starting component or the third starting component is expellable from the third cartridge, by means of the third dispensing plunger, through an opposite opening in the third cartridge in the region of the cartridge head of the first cartridge, wherein the pressing device is arranged behind the third dispensing plunger as seen from the cartridge head and the pressing device comprises a clamping edge for compressing the third cartridge, wherein the pressing device is propellable appropriately in the direction of the cartridge head such that the third cartridge is progressively compressed axially while the pressing device moves and thus the first dispensing plunger, the second dispensing plunger, and the third dispensing plunger are being propelled in the direction of the cartridge head.

### Claim 14 (depends on 1)

The bone cement applicator according to claim 1, further comprising:
a tubular cartridge, wherein the internal space of the cartridge is cylindrical;
a cartridge head that limits an end of the tubular cartridge;
a separating wall in an axial arrangement in the cylindrical internal space of the cartridge, whereby the separating wall is connected to the jacket surface of the cylindrical internal space of the cartridge, and wherein the separating wall subdivides the cylindrical internal space of the cartridge, which is limited by the cartridge head, into two spatially separated hollow spaces, whereby the first hollow space contains a first pasty starting component of the bone cement, and the separate second hollow space contains a second pasty starting component of the bone cement; and
two dispensing plungers that are arranged in the two hollow spaces of the cartridge such as to be axially displaceable, wherein the dispensing plungers close off the two hollow spaces on the side of the hollow spaces opposite from the cartridge head,
wherein the dispensing plungers are connected to each other on the rear side opposite from the cartridge head by means of a connecting means, wherein a wedge or cone with a blade on the front side of the wedge or cone facing the cartridge head is arranged on the connecting means such that, upon propulsion of the dispensing plungers in the hollow spaces in the direction of the cartridge head, the blade cuts open the separating wall and the wedge or cone pushes the cut-open parts of the separating wall in the direction of the internal wall of the cartridge.

### Claim 15 (depends on 14)

The bone cement applicator according to claim 14, wherein the dispensing plungers are situated at an appropriate distance from each other by means of the connecting means such that the gap between the dispensing plungers is smaller than or equal to the thickness of the separating wall.

### Claim 16 (depends on 1)

A method for application of a pasty multicomponent polymethylmethacrylate bone cement dough, the method comprising:
a) providing the bone cement applicator according to claim 1;
b) inserting the bone cement applicator into an extrusion device, wherein the extrusion device comprises an axially propellable pestle for propulsion of the at least one dispensing plunger and/or of the pressing device or of the connecting means in the internal space of the at least one cartridge in the direction of the opening of the at least one cartridge;
c) moving the three-way valve to the first position or the three-way valve being in the first position and extruding the starting components by means of the extrusion device by axial propulsion of a pestle of the extrusion device, whereby the pestle pushes the at least one dispensing plunger in the direction of the opening, by means of which the starting components are mixed to form the bone cement and the bone cement dough is pushed through the hose and out of the application opening; and
d) moving the three-way valve to the second position, wherein the three-way valve, in the second position of the three-way valve, stops the flow of the starting components out of the at least one cartridge into the hose and part of the bone cement dough that is pressurised between the application opening and the three-way valve is pressed through the three-way valve into the collecting container.

### Claim 17 (depends on 16)

The method according to claim 16, wherein the three-way valve is moved to the first position again in a step e) after step d) and, by this means, the bone so cement dough is guided again through the three-way valve to the application opening, whereby it is preferred for steps c), d), and e) to be repeated once or multiple times in the order given.

### Claim 18 (depends on 16)

The method according to claim 16, wherein, during the extrusion of the starting components in step b), the pressing device is propelled by the pestle in the direction of a mixing tube, the first dispensing plunger simultaneously being pushed in the direction of the mixing tube by the pressing device, the clamping edge of the pressing device pressing the wall of the second cartridge to the internal wall of the first cartridge, the deformed wall of the second cartridge simultaneously pushing the second dispensing plunger in the second cartridge in the direction of the mixing tube, by means of which the starting components of the bone cement of both cartridges are pushed into the mixing tube, wherein the starting components are mixed in the mixing tube to form a pasty cement dough, and the mixed cement dough flows out of an application opening.

### Claim 19 (depends on 16)

The method according to claim 16, wherein, during the extrusion of the starting components in step b), the extrusion of the pasty starting components by means of the extrusion device takes place by axial propulsion of the dispensing plungers with the pestle, whereby the starting components are pushed into the hose, whereby, synchronous with the motion of the dispensing plungers, the separating wall is cut by the blade in the longitudinal direction of the cartridge and the wedge or cone pushes the two cut-open parts of the separating wall in the direction of the internal wall of the cartridge at least sufficiently far outwards such that a further motion of the pestle of the extrusion device is not prevented or impeded by parts of the cut-open separating wall.