Vacuum mixing device with operating element, pressure pump, and vacuum pump for mixing polymethylmethacrylate bone cement

• US 10,065,160 B2
• Filed: 12/07/2016
• Issued: 09/04/2018
• Est. Priority Date: 12/07/2015
• Status: Expired due to Fees

• Current Assignee: Heraeus Medical GmbH (Heraeus Holding GMBH)
• Original Assignee: Heraeus Medical GmbH (Heraeus Holding GMBH)
• Inventors: Vogt, Sebastian, Kluge, Thomas
• Primary Examiner(s): Salamon, Peter A
• Application Number:
  US15/371,345
• Publication Number:
  US 20170157579A1
• Time in Patent Office: 636 Days
• Field of Search: None
• CPC Class Codes: 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
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: B01F 2101/20 Mixing of ingredients for bone cement
• CPC Class Codes: B01F 23/54 wetting solids
• CPC Class Codes: B01F 23/565 by introducing liquids in solid material, e.g. to obtain slurries
• CPC Class Codes: B01F 23/57 Mixing high-viscosity liquids with solids
• CPC Class Codes: B01F 27/80 with stirrers rotating about a substantially vertical axis
• CPC Class Codes: B01F 31/40 with an axially oscillating rotary stirrer
• CPC Class Codes: B01F 33/5012 adapted to be mounted during use on a standard, base or support
• CPC Class Codes: B01F 33/70 Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming
• CPC Class Codes: B01F 35/3202 Hand driven
• CPC Class Codes: B01F 35/7131 Breaking or perforating packages, containers or vials
• CPC Class Codes: B01F 35/717613 Piston pumps
• CPC Class Codes: B01F 35/718 using vacuum, under pressure in a closed receptacle or circuit system
• CPC Class Codes: B01F 35/75425 using pistons or plungers

Abstract

A vacuum mixing device or system mixes polymethylmethacrylate bone cement from a monomer liquid and a cement powder. The device or system comprising at least one cartridge comprising an evacuable interior for mixing of the bone cement, a mixing device for mixing the content in the interior of the at least one cartridge, a receptacle for receiving a separate container containing the monomer liquid or comprising an integrated container containing the monomer liquid, an opening device, which is arranged in the region of the receptacle in a manner movable relative to the receptacle so that, by moving the opening device, a separate container arranged in the receptacle is openable by means of the opening device, or the opening device is arranged in the region of the integrated container in a manner movable relative to the integrated container so that, by moving the opening device, the integrated container is openable by means of the opening device, a vacuum pump, in which a movable vacuum plunger for generating a negative pressure is arranged and delimits a vacuum pump chamber of the vacuum pump, a pressure pump, in which a movable pump plunger for conveying a liquid is arranged and delimits a pressure pump chamber of the pressure pump, a connection line, and a fluid connection. The device or system further comprises an operating element that is operatable from outside, wherein, by means of the operating element, the vacuum plunger in the vacuum pump is movable manually, the pump plunger in the pressure pump is movable manually, the opening device is movable manually relative to the receptacle or relative to the integrated container, and the mixing device is movable manually in the interior of the cartridge.

Claims

1. A vacuum mixing device for mixing polymethylmethacrylate bone cement from a monomer liquid and a cement powder, the vacuum mixing device comprising:

at least one cartridge having an evacuable interior for mixing of the bone cement,

a mixing device for mixing the content in the interior of the at least one cartridge, which is arranged movably in the interior,

a receptacle for receiving a separate container containing the monomer liquid or comprising an integrated container containing the monomer liquid, an opening device, which is arranged in the region of the receptacle in a manner movable relative to the receptacle so that, by moving the opening device, a separate container arranged in the receptacle is openable by means of the opening device, or the opening device is arranged in the region of the integrated container in a manner movable relative to the integrated container so that, by moving the opening device, the integrated container is openable by means of the opening device,

a vacuum pump, in which a movable vacuum plunger for generating a negative pressure is arranged and delimits a vacuum pump chamber of the vacuum pump,

a pressure pump, in which a movable pump plunger for conveying a liquid is arranged and delimits a pressure pump chamber of the pressure pump,

a connection line, which connects the interior of the at least one cartridge to the vacuum pump chamber of the vacuum pump, and

a fluid connection, which connects the interior of the at least one cartridge to the pressure pump chamber of the pressure pump, wherein the vacuum mixing system comprises an operating element that is operatable from outside, wherein the vacuum plunger in the vacuum pump is movable manually by means of the operating element,

the pump plunger in the pressure pump is movable manually by means of the same operating element,

the opening device is movable relative to the receptacle or relative to the integrated container by means of the same operating element, and herein

the mixing device in the interior of the cartridge is movable by means of the same operating element in order to mix the content in the interior of the cartridge.

2. The vacuum mixing device according to claim 1, wherein the operating element is connected or connectable to the vacuum plunger and to the pump plunger in such a way that the vacuum plunger is movable manually in the vacuum pump and the pump plunger is movable manually in the pressure pump by operation of the operating element.

3. The vacuum mixing device according to claim 1, wherein the receptacle, at least in regions, has closed side walls for receiving a glass ampoule as separate container, wherein the receptacle has at least one deformable closed side wall and a supporting element is provided opposite the deformable side wall, wherein the opening device is pressable via the operating element against the deformable side wall of the receptacle so that the deformable side wall deforms in such a way that a matching glass ampoule arranged in the receptacle can be broken open by means of the opening device.

4. The vacuum mixing device according to claim 1, wherein the opening device has a first lever which is mounted rotatably about a first axis in relation to the receptacle or the integrated container, wherein a free end of the first lever is pushable against a deformable side wall of the receptacle or the integrated container, wherein the operating element is formed by a second lever, which is mounted rotatably about a second axis in relation to the receptacle or the integrated container, wherein the second axis divides the second lever into a short lever arm and a long lever arm, wherein an end of the short lever arm is to be pushed by manual operation of the long lever arm against the first lever so that the free end of the first lever pushes against the deformable side wall and deforms this in such a way that a separate container disposed in the receptacle is openable, or pushes the free end of the first lever against the integrated container so that the integrated container opens towards a fluid connection.

5. The vacuum mixing device according to claim 1, wherein the operating element is manually movable, wherein the operating element is operatively connected to or is to be brought into operative connection with the opening device, the vacuum pump, the pressure pump, and the mixing device in such a way that with a first operation of the operating element a separate container in the receptacle or the integrated container is to be opened, and with a further operation of the operating element the vacuum plunger in the vacuum pump is to be driven, the pump plunger in the pressure pump is to be driven, and the mixing device in the interior is to be driven.

6. The vacuum mixing device according to claim 5, wherein the vacuum plungerof the vacuum pump, the pump plunger of the pressure pump and/or the mixing device are/is to be driven via a flexible cable and/or a rod, wherein a detent means is provided on the flexible cable and/or the rod and after first-time operation of the operating element engages with a mating detent means on the operating element or with a mating detent means connected to the operating element so that, with operation of the operating element subsequent to the latching, the vacuum plunger of the vacuum pump, the pump plunger of the pressure pump and/or the mixing device are/is to be driven via the cable and/or the rod by means of the operating element.

7. The vacuum mixing device according to claim 1, wherein the mixing device is axially movable in the interior in the longitudinal direction by operation of the operating element.

8. The vacuum mixing device according to claim 1, wherein the mixing device is rotatable about the longitudinal axis of the interior by operation of the operating element, wherein a cylinder connected to the mixing device and having an external thread moves in a stationary sleeve having a matching internal thread so that, when the cylinder moves along the longitudinal direction within the sleeve, a rotation of the cylinder is enforced, wherein the rotation of the cylinder transfers to the mixing device in the interior of the cartridge.

9. The vacuum mixing device according to claim 1, wherein the vacuum pump chamber of the vacuum pump is gas-tight and is arranged in the interior of the vacuum pump, wherein the vacuum plunger is manually drivable via the operating element in at least one direction, such that the vacuum pump chamber is to be enlarged by the movement of the vacuum plunger and the interior of the at least one cartridge is to be evacuable through the connection line by means of the resultant negative pressure created in the vacuum pump chamber.

10. The vacuum mixing device according to claim 1, wherein the pressure pump chamber of the pressure pump is liquid-tight and is arranged inside the pressure pump, wherein the pump plunger is manually drivable via the operating element in at least one direction so that the pressure pump chamber is to be made smaller by the movement of the pump plunger and the monomer liquid is to be pushed from the pressure pump chamber through the fluid connection into the interior of the at least one cartridge by means of the resultant pressure created in the pressure pump chamber.

11. The vacuum mixing device according to claim 1, wherein a first one-way valve is arranged in the connection from the vacuum pump chamber to the connection line or in the connection line, which first one-way valve is open or is actively opened when a pressure lower than in the interior of the cartridge prevails in the vacuum pump chamber and is in a closed state or is actively closed when a pressure equal to or higher than in the interior of the cartridge prevails in the vacuum pump chamber, and a second one-way valve connects the vacuum pump chamber to the surroundings of the vacuum pump, which second one-way valve is open or is actively opened when a pressure higher than in the surroundings of the vacuum pump prevails in the vacuum pump chamber and is in the closed state or is actively closed when a pressure equal to or lower than in the surroundings of the vacuum pump prevails in the vacuum pump chamber.

12. The vacuum mixing device according to claim 1, wherein the vacuum plunger and the pump plunger are mounted axially movably in a hollow cylinder, wherein the hollow cylinder is closed on a first side or is closed apart from a feedthrough for a rod or cable connected to the operating element and the vacuum plunger and pump plunger, in particular is closed by a closure, wherein a vacuum pump chamber is formed in the hollow cylinder between the vacuum plunger and the first closed side, and a pressure pump chamber is formed in the hollow cylinder between the pump plunger and a closure, wherein the closure of the hollow cylinder is arranged on the side of the hollow cylinder opposite the first side.

13. The vacuum mixing device according to claim 1, wherein the vacuum plunger and/or the pump plunger are/is connected or connectable to the operating element via a rod and/or a cable, and the vacuum plunger is to be moved in the vacuum pump by operation of the operating element and/or the pump plunger is to be moved in the pressure pump by operation of the operating element.

14. The vacuum mixing device according to claim 1, wherein a movable dispensing plunger for discharging the mixed bone cement from the cartridge is arranged in the interior of the cartridge, wherein the dispensing plunger is releasably locked or lockable in order to prevent a movement of the dispensing plunger under the action of the negative pressure.

15. The vacuum mixing device according to claim 1, wherein the cartridge is a cement cartridge filled with cement powder and a separate container containing a monomer liquid is arranged in the receptacle or a monomer liquid is contained in the integrated container, wherein the receptacle or the integrated container is connected in a liquid-impermeable manner to the interior of the cement cartridge by means of a separating element that is openable and/or the interior of the cement cartridge is connected or connectable in a gas-permeable manner to the vacuum pump.

16. The vacuum mixing device according to claim 1, wherein the cartridge, the vacuum pump, the pressure pump and all lines and also the receptacle or the integrated container are fixedly and/or releasably connected to a common base part and/or a housing, wherein the vacuum pump, the pressure pump and all lines as well as the receptacle or the separate container are fixedly connected to the base part and/or a housing and the cartridge is releasably connected to the base part and/or a housing.

17. The vacuum mixing device according to claim 1, wherein the separate container containing the monomer liquid is a film bag which can be cut open or torn open in the receptacle by means of the opening device, or is a glass ampoule which can be broken open in the receptacle by means of the opening device.

18. The vacuum mixing device according to claim 1, wherein the receptacle or the integrated container is connected or connectable via a fluid connection to the interior of the cartridge, wherein the mouth of the fluid connection into the interior of the cartridge is arranged on the opposite side of the mouth of the connection line between the interior and the vacuum pump chamber.

19. The vacuum mixing device according to claim 1, wherein a negative pressure is to be generated in the vacuum pump chamber as a result of the movement of the vacuum plunger in the vacuum pump, wherein a gas is evacuable through the connection line from the interior of the at least one cartridge by means of the negative pressure.

20. The vacuum mixing device according to claim 1, wherein the vacuum pump and the pressure pump are constructed as a combined pressure-vacuum pump, the pressure-vacuum pump comprising a hollow cylinder with a gas-tight closure at a first hollow cylinder end and a liquid-tight closure at the opposite second hollow cylinder end, wherein the hollow cylinder is connected or connectable at the first and at the second hollow cylinder end to the interior of the cartridge, the vacuum plunger, which is arranged in the hollow cylinder in a gas-tight and axially movable manner, and the pump plunger, which is arranged in the hollow cylinder in a liquid-tight and axially movable manner, wherein the vacuum plunger and the pump plunger in the pressure-vacuum pump are movable by means of the manually operable operating element, wherein with a movement of the vacuum plunger by means of the manually operable operating element, the vacuum plunger is movable axially away from the gas-tight closure and gas can thus be evacuated from the interior of the cartridge (6), and, when the pump plunger is moved by means of the manually operable operating element, the pump plunger is movable axially towards the liquid-tight closure and a monomer liquid can thus be pushed from the pump chamber into the interior of the cartridge, wherein the operating element is operatively connected to the opening device, and wherein the operating element is connected to the mixing device in the interior of the cartridge in such a way that the mixing device in the interior of the cartridge is movable with operation of the operating element.

21. The vacuum mixing device according to claim 1, characterised in that the vacuum pump, the pressure pump, the opening device, and the mixing device are drivable via the movement of the operating element, wherein the operating element is moved by the action of manual force.

22. The vacuum mixing device according to claim 1, wherein the vacuum pump and the pressure pump are embodied as a combined pressure-vacuum pump, wherein the vacuum plunger and pump plunger are distanced from one another via a connection.

23. The vacuum mixing device according to claim 22, wherein the distance between the sides of the vacuum plunger and the pump plunger facing away from one another is at least exactly the same as the maximum stroke of the vacuum plunger and the pump plunge.

24. The vacuum mixing device according to claim 1, wherein the pump plunger is movable only in one direction in order to reduce the size of the pressure pump chamber and then cannot be moved back in the opposite direction, and is movable by the connection only in a direction for reducing the size of the pressure pump chamber.

25. A method for mixing polymethylmethacrylate bone cement in an interior of a cartridge of the vacuum mixing device, according to claim 1, the method comprising:

operating an operating element such that an integrated container of the vacuum mixing device or a separate container, which is arranged in a receptacle of the vacuum mixing device, is thus opened, wherein a monomer liquid contained in the integrated container or the separate container then flows as first component of the bone cement into a pressure pump chamber of a pressure pump,

by means of a subsequent, further operation of the operating element, a movement of a vacuum plunger of a vacuum pump of the vacuum mixing device is driven, wherein a negative pressure is generated in a vacuum pump chamber of the vacuum pump by means of the movement of the vacuum plunger, wherein the interior of the cartridge is evacuated by means of the vacuum pump driven in this way,

a movement of a pump plunger of a pressure pump of the vacuum mixing device is driven by the further operation of the operating element, wherein a pressure is exerted onto the monomer liquid in the pressure pump chamber by means of the movement of the pump plunger and the monomer liquid is pushed from the pressure pump chamber into the interior of the cartridge, wherein a bone cement powder as second component of the bone cement is already disposed in the interior of the cartridge, and

a mixing device in the interior of the cartridge is moved as a result of the operation of the operating element and a bone cement dough in the interior of the cartridge formed from the cement powder and the monomer liquid is mixed as a result of the movement of the mixing device.

26. The method according to claim 25, where the volume of a vacuum pump chamber of the vacuum pump is increased by the manual movement of the vacuum plunger and the interior of the cartridge is evacuated due to the negative pressure created as a result and/or the volume of the pressure pump chamber of the pressure pump is made smaller by the manual movement of the pump plunger and the monomer liquid is pushed from the pressure pump chamber into the interior of the cartridge due to the pressure created as a result.

27. The method according to claim 25, wherein the vacuum plunger of the vacuum pump is moved, whereby a negative pressure relative to the surrounding atmosphere is generated in the vacuum pump, in so doing gas from the interior of the cartridge is sucked into the vacuum pump chamber of the vacuum pump through a connection line, and the pump plunger of the pressure pump is moved by means of the operating element, whereby a pressure is exerted onto the monomer liquid in the pressure pump chamber, the monomer liquid is pushed through a fluid connection from the pressure pump chamber into the interior of the cartridge, the mixing device in the interior of the cartridge is then moved by operation of the same operating element, and in so doing the cement powder is mixed with the monomer liquid, the cartridge containing the mixed cement dough is then removed, and the cement dough is pressed out from the cartridge by means of an axial movement of a dispensing plunger.

28. The method according to claim 25, wherein the cement powder is arranged in the cartridge, the monomer liquid is arranged in a receptacle separate from the cartridge, wherein the monomer liquid is contained in an integrated container or in a separate container, the integrated container or the separate container is opened by operation of the operating element and a resultant movement of the opening device, before the vacuum plunger and the pump plunger are driven by a further operation of the operating element, the vacuum plunger and the pump plunger are then moved axially in a hollow cylinder, in so doing gas from the interior of the cartridge is sucked through the connection line into the vacuum pump chamber delimited by the hollow cylinder, and the monomer liquid disposed in the pressure pump chamber delimited by the hollow cylinder is pushed through the fluid connection into the interior of the cartridge.