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

• US 10,022,687 B2
• Filed: 12/07/2016
• Issued: 07/17/2018
• 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:
  US15/371,336
• Publication Number:
  US 20170157578A1
• Time in Patent Office: 587 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 35/718 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 for mixing PMMA bone cement from a monomer liquid and a cement powder, the vacuum mixing device 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, 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 pump, in which a movable plunger for generating a negative pressure is arranged and delimits a pump chamber of the pump, and a connection line, which connects the interior of the at least one cartridge to the pump chamber of the pump, wherein the vacuum mixing system comprises an operating element that is operatable from outside, wherein the plunger in the pump is movable manually by means of the operating element, and wherein the opening device is movable relative to the receptacle or relative to the integrated container by means of the same operating element, and 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.

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 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, 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, that is arranged in the region of the receptacle in a manner movable relative to the receptacle such 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 pump, in which a movable plunger for generating a negative pressure is arranged and delimits a pump chamber of the pump, and

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

the vacuum mixing system comprises an operating element that is operatable from outside, wherein the plunger in the pump is movable manually by means of the operating element, and further wherein

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

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 is connectable, to the plunger such that the plunger is movable manually in the 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 such 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 first 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 about an axis, wherein the operating element (4) is operatively connected to or is to be brought into operative connection with the opening device, the pump, and the mixing device such that a first operation of the operating element, and with a further operation of the operating element, the plunger in the 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 plunger of the 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 plunger of the 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 for this purpose 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 pump chamber of the pump is gas-tight and is arranged in the interior of the pump, wherein the plunger is manually drivable via the operating element in at least one direction, such that the pump chamber is to be enlarged by the movement of the 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 pump chamber.

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

11. The vacuum mixing device according to claim 1, wherein the plunger is 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 plunger, in particular is closed by a closure, wherein a pump chamber is formed in the hollow cylinder between the plunger and the first closed side, wherein the hollow cylinder is open on a second side.

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

13. 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 preferably releasably locked or is lockable in order to prevent a movement of the dispensing plunger under the action of the negative pressure.

14. 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 preferably connected in a liquid-impermeable manner to the interior of the cement cartridge by means of a separating element that is to be opened and/or the interior of the cement cartridge is connected or connectable in a gas-permeable manner to the pump.

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

16. 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.

17. 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 pump chamber.

18. The vacuum mixing device according to claim 17, wherein a loop is arranged in the fluid connection, such that the monomer liquid running out from the opened separate container or the integrated container cannot flow into the interior of the cartridge without negative pressure in the interior of the cartridge, wherein a storage volume for receiving the liquid volume of the monomer liquid is preferably arranged below the receptacle or the integrated container.

19. The vacuum mixing device according to claim 1, wherein a negative pressure is to be generated in the pump chamber as a result of the movement of the plunger in the 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 pump is constructed with a hollow cylinder, wherein the hollow cylinder is connected or connectable to the interior of the cartridge, a gas-tight closure at one hollow cylinder end, the plunger, which is arranged in the hollow cylinder in a gas-tight and actually movable manner, wherein the plunger in the pump is movable by means of the manually operable operating element, wherein with a movement of the plunger by means of the manually operable operating element, the plunger is movable axially oppositely to the closure and gas can thus be evacuated from 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, wherein the pump, the opening device, and the mixing device are drivable via the movement of the operating element, wherein the operating element is preferably moved by the action of manual force.

22. 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 the operating element and 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 runs out as first component of the bone cement, by means of a subsequent, further operation of the operating element, a movement of a plunger of a pump of the vacuum mixing device is driven, wherein a negative pressure is generated in a pump chamber of the pump by means of the movement of the plunger, wherein the interior of the cartridge is evacuated by means of the pump driven in this way and the monomer liquid is conducted into the interior of the cartridge by means of the negative pressure in 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

moving 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.

23. The method according to claim 22, wherein the volume of a pump chamber of the pump is increased by the manual movement of the plunger and the interior of the cartridge is evacuated due to the negative pressure created as a result.

24. The method according to claim 22, wherein the plunger of the pump is moved by means of the operating element, whereby a negative pressure relative to the surrounding atmosphere is generated in the pump, in so doing gas from the interior of the cartridge is sucked into the pump chamber of the pump through a connection line, and 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.

25. The method according to claim 22, 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, preferably in a glass ampoule in the receptacle, 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 plunger is driven by a further operation of the operating element, the plunger is then moved axially in a hollow cylinder, whereby a negative pressure compared to the surrounding atmosphere is generated, in so doing gas from the interior of the cartridge is sucked through the connection line into the hollow cylinder, and monomer liquid is sucked into the cartridge by means of the negative pressure formed in the interior of the cartridge.