Vacuum mixing system and method for the mixing of polymethylmethacrylate bone cement
10130926 ยท 2018-11-20
Assignee
Inventors
Cpc classification
B01F33/70
PERFORMING OPERATIONS; TRANSPORTING
B01F31/441
PERFORMING OPERATIONS; TRANSPORTING
B01F33/71
PERFORMING OPERATIONS; TRANSPORTING
B01F33/50112
PERFORMING OPERATIONS; TRANSPORTING
B01F35/7131
PERFORMING OPERATIONS; TRANSPORTING
F04B33/00
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
B01F33/5014
PERFORMING OPERATIONS; TRANSPORTING
B01F2101/20
PERFORMING OPERATIONS; TRANSPORTING
B01F35/718
PERFORMING OPERATIONS; TRANSPORTING
B01F23/511
PERFORMING OPERATIONS; TRANSPORTING
B01F35/754251
PERFORMING OPERATIONS; TRANSPORTING
International classification
F04B33/00
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
Abstract
A vacuum mixing system for the mixing of polymethylmethacrylate bone cement, comprising at least one cartridge (4) having an evacuable internal space for mixing of the bone cement, a pump (18) for generating a negative pressure, and a connecting conduit (12) connecting the internal space of the at least one cartridge (4) to the pump (18) for generating a negative pressure, an integrated energy reservoir (28) for driving the pump (18) that is or can be connected to the pump (18) and has energy for at least one pumping process of the pump (18) stored in it, whereby a negative pressure can be generated by means of the pump (18) during the pumping process, which negative pressure can be used to evacuate gas from the internal space of the at least one cartridge (4) through the connecting conduit (12).
Claims
1. Vacuum mixing system for the mixing of polymethylmethacrylate bone cement, comprising at least one cartridge (4, 54) having an evacuable internal space for mixing of the bone cement, a pump (18, 68) for generating a negative pressure, and a connecting conduit (12, 62) connecting the internal space of the at least one cartridge (4, 54) to the pump (18, 68) for generating a negative pressure, wherein the vacuum mixing system comprises an integrated energy reservoir (28, 78) for driving the pump (18, 68) that is or can be connected to the pump (18, 68) and has energy for at least one pumping process of the pump (18, 68) stored in it, whereby a negative pressure can be generated by means of the pump (18, 68) during said at least one pumping process by consuming energy from the integrated energy reservoir (28, 78) such that the negative pressure can be used to evacuate gas from the internal space of the at least one cartridge (4, 54) through the connecting conduit (12, 62), wherein said integrated energy reservoir (28, 78) is a tensioned restoring element (28, 78).
2. Vacuum mixing system according to claim 1, wherein the pump (18, 68) comprises a gas-tight pumping space (26, 76) and a mobile plunger (22, 72) or a mobile wall is provided in the pump (18, 68) to serve as boundary of the pumping space (26, 76), whereby the plunger (22, 72) or wall can be driven in one direction by the energy of the integrated energy reservoir (28, 78) such that the motion of the plunger (22, 72) or wall enlarges the pumping space (26, 76) and the negative pressure thus arising in the pumping space (26, 76) allows the internal space of the at least one cartridge (4, 54) to be evacuated through the connecting conduit (12, 62).
3. Vacuum mixing system according to claim 2, wherein said enlargement of the pumping space (26, 76) is by a volume that is at least equal to the free volume of the internal space of the cartridge (4, 54).
4. Vacuum mixing system according to claim 1, wherein the vacuum mixing system comprises a mixing device for the mixing of the content of the at least one cartridge (4, 54), whereby the mixing device is arranged in the internal space of the cartridge (4, 54) and/or can be driven manually or through a motor.
5. Vacuum mixing system according to claim 1, wherein said vacuum mixing system has a total weight that is less than 30 kg.
6. Vacuum mixing system according to claim 1, wherein the vacuum mixing system comprises a manually-operable operating element (30, 80) that can be operated to release the energy from the energy reservoir (28, 78), whereby the released energy drives the pump (18, 68) and the driven pump (18, 68) evacuates the internal space of the cartridge (4, 54).
7. Vacuum mixing system according to claim 1, wherein a mobile dispensing plunger (9, 10, 59, 60) for dispensing the mixed bone cement from the cartridge (4, 54) is arranged in the internal space of the cartridge (4, 54), whereby the dispensing plunger (9, 10, 59, 60) is or can be locked in place in detachable manner in order to prevent the dispensing plunger (9, 10, 59, 60) from moving in response to the effect of the negative pressure.
8. Vacuum mixing system according to claim 1, wherein an expansion or contraction of the tensioned restoring element (28, 78) generates a negative pressure in the internal space of the cartridge (4, 54).
9. Vacuum mixing system according to claim 1, wherein the cartridge (4, 54) is a cement cartridge (4, 54) filled with cement powder and the vacuum mixing system comprises a container (2) that is separate from the cement cartridge (4, 54) and contains a monomer liquid, whereby the container (2) is connected, in liquid-impermeable manner, to the internal space of the cement cartridge (4, 54) through a separating element (44) that can be opened, and the internal space of the cement cartridge (4, 54) is or can be connected to the pump (18, 68) in gas-permeable manner.
10. Vacuum mixing system according to claim 1, wherein the pump (18, 68) comprises a hollow cylinder (20, 70), whereby the hollow cylinder (20, 70) is or can be connected to the internal space of the cartridge (4, 54); a gas-tight closure on one end of the hollow cylinder; a plunger (22, 72) that is arranged in the hollow cylinder (20, 70) such as to be gas-tight and axially mobile; said tensioned restoring element is a spring (28, 78) that is arranged between the plunger (22, 72) and the closure; a connecting element (30, 80) that is connected, in detachable manner, to the plunger (22, 72) and keeps the plunger (22, 72) in position in the hollow cylinder (20, 70) and keeps the spring (28, 78) tensioned or compressed, whereby the connecting element (30, 80) is guided out of the hollow cylinder (20, 70) through a gas-tight feed-through and can be detached from the plunger (22, 72) from outside, whereby, after detaching the connection of the connecting element (30, 80), the plunger (22, 72) can be moved axially opposite to the closure by the expansion of the spring (28, 78).
11. Vacuum mixing system according to claim 10, wherein said spring (28, 78) is compressed in the storage state and is kept in the compressed state by the plunger (22, 72) of the pump (18, 68) by means of the locked connecting element (30, 80).
12. Vacuum mixing system according to claim 10 wherein the plunger (22, 72) is shifted inside the hollow cylinder (20, 70) after expansion of said spring (28, 78) such that the volume of the pumping space (26, 76) formed by the hollow cylinder (20, 70), the closure, and the plunger (22, 72) is at least equal to the volume of the internal space of the cartridge (4, 54) to be evacuated.
13. Vacuum mixing system according to claim 10, wherein a boundary element is arranged on the end of the hollow cylinder (20, 70) and limits the motion of the plunger (22, 72) such that the plunger cannot exit from the hollow cylinder (20, 70).
14. Vacuum mixing system according to claim 10, wherein the plunger (22, 72) contains, on the side facing away from the closure, an optical marker (34, 87) that can be recognized visually on the outside of the vacuum mixing system after a maximal motion of the plunger (22, 72) took place and thus indicates the position of the plunger (22, 72) after its maximal motion.
15. Method for the mixing of polymethylmethacrylate bone cement in an internal space of a cartridge (4, 54) of a vacuum mixing system according to claim 1, wherein energy stored in the tensioned restoring element (28, 78) that is integrated into the vacuum mixing system is used to drive a pump (18, 68) of the vacuum mixing system, whereby the pump (18, 68) thus driven is used to evacuate the internal space of the cartridge (4, 54) and to mix a bone cement in the internal space of the cartridge (4, 54).
16. Method according to claim 15, wherein the volume of a pumping space (26, 76) of the pump (18, 68) is enlarged by relaxation of the tensioned restoring element (28, 78), and the internal space of the cartridge (4, 54) is evacuated by the negative pressure thus generated.
17. Method according to claim 15, wherein the internal space of the cartridge (4, 54) contains a cement powder, and the pump (18, 68) evacuates a gas from the internal space of the cartridge (4, 54), a monomer liquid is guided into the internal space of the cartridge (4, 54), and the monomer liquid is mixed with the cement powder in the evacuated internal space of the cartridge (4, 54).
18. Method according to claim 15, wherein a connecting element (30, 80) is detached from a plunger (22, 72) of the pump (18, 68); followed by said tensioned restoring element (28, 78) moving the plunger (22, 72) axially in a hollow cylinder (20, 70) of the pump (18, 68), by means of which a negative pressure is generated; whereby gas is aspirated from the internal space of the cartridge (4, 54) through a connecting conduit (12, 62) into the hollow cylinder (20, 70); followed by a cement powder being mixed, manually or motor-driven, with a monomer liquid by means of a mixing device (6, 56); followed by the cartridge (4, 54) with the mixed cement dough being removed; and the cement dough being extruded from the cartridge (4, 54) by moving a dispensing plunger axially (9, 10, 59, 60).
19. Method according to claim 15, wherein the cement powder is arranged in the cartridge (4, 54); the monomer liquid is arranged in a container (2) that is separate from the cartridge (4, 54), whereby the monomer liquid is separated from the cement powder in the cartridge (4, 54) by means of a separating element (44); the separating element (44) is opened before the connecting element (30, 80) is detached from the plunger (22, 72) such that a liquid-permeable connection is established between the internal space of the cartridge (4, 54) and the container (2); followed by the tensioned restoring element (28, 78) moving the plunger (22, 72) axially in the hollow cylinder (20, 70), whereby a negative pressure is generated; whereby gas is aspirated from the internal space of the cartridge (4, 54) through the connecting conduit (12, 62) into the hollow cylinder (20, 70), and monomer liquid is aspirated into the cartridge (4, 54) through the negative pressure formed in the internal space of the cartridge (4, 54).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Further exemplary embodiments of the invention shall be illustrated in the following on the basis of four schematic figures, though without limiting the scope of the invention. In the figures:
(2)
(3)
(4)
(5)
(6)
(7) The cartridge system 1 comprises a cylindrical cartridge 4 having a circular base surface that is fastened perpendicularly to the foot part 3. For this purpose, an opening having an internal thread is provided on the front side of the cartridge 4 that is screwed onto a socket on the foot part 3, which has an external thread. A cement powder (not shown) is present on the inside of the cartridge 4. Moreover, a mixing device having two or more mixing vanes 6 that are fastened on a mixing tube 8 is arranged on the inside of the cartridge 4. The mixing tube 8 is guided through a sterilisation plunger 9 such that it can be rotated and shifted in longitudinal direction. For this purpose, the feed-through is pressure-tight and gas-tight. The sterilisation plunger 9 comprises a membrane (not shown) that is permeable for a sterilising gas, but impermeable for the cement powder. The sterilisation plunger 9 is inserted into the cartridge 4 after the cement powder is filled in and closes the internal space of the cartridge 4 with respect to the outside. Subsequently, the content of the cartridge 4 can be sterilised through the permeable membrane using ethylene dioxide.
(8) A sealing plunger 10 can be pushed into the sterilisation plunger 9 and can be connected to same in gas-tight and pressure-tight manner. The plungers 9, 10, which are fastened to each other, then together form a dispensing plunger 9, 10 by means of which the content of the cartridge 4 can be extruded through the floor-side opening. However, the sterilisation plunger 9 is initially locked on the opposite side (on the top in
(9) A handle part 11 is attached on the mixing tube 8 outside the cartridge 4 by means of which the mixing vanes 6 on the inside of the cartridge 4, i.e. in the internal space of the cartridge 4, can be manually rotated and shifted in the longitudinal direction of the cartridge 4.
(10) A feed-through that is connected to a connecting conduit 12 in the form of a flexible vacuum conduit 12 is provided in the sealing plunger 10. Apart from this, the sealing plunger 10 is tight. The front side of the cartridge 4 (on the bottom in
(11) The pump 18 comprises a stable hollow cylinder 20 that is separated into two parts in pressure-tight manner by means of a plunger 22. An outlet and/or a connector 24 for the vacuum conduit 12 is provided in the rear part (on the left in
(12) The vacuum mixing system is characterised by a tensioned steel spring 28 that is arranged in the pumping space 26 about a screw 30 and about a cylindrical extension on the plunger 22. The screw 30 is guided, in gas-tight and pressure-tight manner and rotatably, through a feed-through into the pumping space 26. For this purpose, the screw 30 forms a closure of the pumping space 26 and/or of the internal space of the hollow cylinder 20. By this means, the pumping space 26 is tight except for the connector 24. The screw 30 is screwed into an internal thread 33 in the cylindrical extension of the plunger 22 by means of an external thread 32 and thus keeps the plunger 22 in position. The steel spring 28 is compressed and/or tensioned between the plunger 22 and the side (the base surface) of the hollow cylinder 20 having the feed-through for the screw 30 (the side is drawn on the left side of the hollow cylinder 20 in
(13) A projection 34 in the form of a pin 34 is arranged on the side of the plunger 22 that is opposite from the screw 28 and can exit from the hollow cylinder 20 through an opening 36 in the base surface of the hollow cylinder 20 that is situated opposite from the base surface having the feed-through for the screw 30. When the pin 34 projects through the opening 36, it can be recognised directly from outside that the pump 18 has triggered and the pumping process completed.
(14) A glass ampoule 40 having a breakable head 42 is arranged in the liquid container 2. The glass ampoule 40 contains the monomer liquid. The head 42 of the glass ampoule 40 can be broken off or sheared off by rotating a rotating lever 44. The rotating lever 44 thus opens the connection and thus establishes a connection between the monomer liquid and the liquid conduit 14. In addition, a valve element (not shown) that can be opened by the rotating lever 44 can also be provided at the inlet of the liquid container 2 into the liquid conduit 14. The liquid container 2 is closed in gas-tight and pressure-tight manner by a lid 46 after the glass ampoule 40 has been inserted into the liquid container 2. After breaking the glass ampoule 40 open, the monomer liquid in the liquid container is available and can be guided through the liquid conduit 14 into the internal space of the cartridge 4 by using a negative pressure in the internal space of the cartridge 4 to aspirate the monomer liquid from the liquid container 2 into the internal space of the cartridge 4. The monomer liquid can then be mixed with the cement powder in the internal space of the cartridge 4 by means of the mixing device in a vacuum and/or at a negative pressure in order to generate the bone cement and/or a bone cement paste.
(15) According to the invention, the vacuum mixing system is characterised by the following procedure. The pump 18 is triggered by rotating the screw 30 by its external thread 28 out of the internal thread 33 of the plunger 22. This is done once the cartridge 4 is made ready for use by inserting the sealing plunger 10, as is shown in
(16) The plunger 22 is accelerated up to the end of the hollow cylinder 20 (on the right in
(17) Once the starting components have been mixed in the internal space of the cartridge 4, the mixing tube 8 is pulled upwards out of the internal space of the cartridge 4 as far as it will go and can then be broken off at a predetermined breakage site. The sealing plunger 10 is rotated with respect to the sterilisation plunger 9 and thus the gas feed-through through the sealing plunger 10 is closed. The vacuum conduit 12 is then pulled off the sealing plunger 10. The cartridge 4 is unscrewed from the foot part 3 and a dispensing tube (not shown), by means of which the mixed bone cement can be applied, is screwed into the internal thread. The conveying plunger or dispensing plunger composed of the sterilisation plunger 9 and the sealing plunger 10 is unlocked and can be driven into the inside of the cartridge 4 by means of an application device (not shown). As a result, the content of the cartridge 4, i.e. the bone cement mixed at a negative pressure, is extruded from the opposite opening and through the screwed-on dispensing tube.
(18) Except for the glass ampoule 40 and the steel spring 28 and the starting components of the bone cement, the components of the vacuum mixing system can be manufactured from a plastic material by means of injection moulding. The conduits 12, 14 can consist of a different plastic material. The vacuum conduit 12 must be flexible in order to be able to arrange the sealing plunger 10 on the mixing tube 8 such as to be mobile.
(19) Except for the head of the screw 30, the conduits 12, 14 and the pump 18 are arranged in a housing made of plastic material that comprises a level bottom such that the vacuum mixing system can be set up on a level support.
(20) Using the vacuum mixing system described above, the two starting components of the bone cement can be stored and mixed in a vacuum at any later point in time. The vacuum mixing system does not need to be connected to any external supply (power, water or compressed gas) in this context. The energy required to generate the negative pressure is stored in the tensioned steel spring 28 serving as energy reservoir. As an alternative to the compression spring 28, a tensioned tension spring that is tensioned, for pulling, between the opening 36 and the plunger 22 in the internal space of the hollow cylinder 20 could be used just as well or a tensioned gas spring could be used. However, the design involving a steel spring 28, in particular involving a compression spring 28, is simpler and less expensive.
(21)
(22) Mixing vanes 56 of a mixing device are arranged in the internal space on a mixing tube 58 that is mobile in longitudinal direction and axially rotatable in the internal space of the cartridge 54. For this purpose, the mixing tube 58 is guided through a two-part dispensing plunger 59, 60 that consists of a sterilisation plunger 59 and a sealing plunger 60. The function of the two dispensing plunger parts 59, 60 is equivalent to the function of the dispensing part plungers 9, 10 according to the first exemplary embodiment. The mixing tube 58 ends at a handle part 61 by means of which the mixing device can be operated from outside the cartridge 54.
(23) In contrast to the embodiment according to
(24) The vacuum conduit 62 is connected to a pump 68 that is designed to include a hollow cylinder 70, regions of which are open on one side (opened on the bottom in
(25) The compression spring 78 accelerates the unlocked and/or detached plunger 72 in the direction of the base 53. While the air escapes from the part of the internal space of the hollow cylinder 70 facing the base 53 through an opening 86, the pressure in the expanding pumping space 76 decreases. As a result, gases are evacuated from the vacuum conduit 62 and through the vacuum conduit 62 from the internal space of the cartridge 54. The compression spring 78 pushes the plunger 72 against the base surface of the hollow cylinder 70 facing the base 53. In this context, a projection 84 on the side of the plunger 72 facing the base 53 is pushed through the opening 86 and, in this location, tips a rocker lever 87. Due to the motion and the position of the rocker lever 87, it can be recognised from outside whether or not the pump 68 has completed the pumping process. The increase in the volume of the pumping space 76 due to the pumping process is sufficient to generate a sufficient vacuum in the internal space of the cartridge 54. A vacuum can be sufficient already, if the pressure in the internal space of the cartridge 54 is reduced by at least 50%, though preferably it is reduced by at least 90%.
(26) After the internal space of the cartridge 54 has been evacuated, the starting components filled into it can be mixed by means of the mixing device by moving the mixing tube 58 with the handle 61. Subsequently, the sealing plunger 60 is rotated against the sterilisation plunger 59 and the gas feed-through is thus closed by the sealing plunger 60. The vacuum conduit 62 is pulled off and/or removed from the sealing plunger 60. The cartridge 54 is unscrewed from the base 53 and a dispensing tube (not shown), by means of which the mixed bone cement can be applied from the cartridge 54, is screwed into the internal thread. The dispensing plunger 59, 60, which is composed of the sterilisation plunger 59 and the sealing plunger 60, is unlocked and can be driven into the inside of the cartridge 54 by means of an application device, i.e. a common extrusion device (not shown). By this means, the content of the cartridge 54, i.e. the bone cement mixed at negative pressure, is extruded from the opposite opening and through the dispensing tube screwed onto it.
(27) Except for the starting components of the bone cement, the components of the vacuum mixing system can be manufactured by injection moulding of a plastic material. However, the compression spring 78 is also preferred to consist of steel. The vacuum conduit 62 can consist of a different plastic material. The vacuum conduit 62 must be flexible in order to be able to arrange the sealing plunger 60 in mobile manner on the mixing tube 58.
(28) There is no need to connect the vacuum mixing system to any external supply (power, water or compressed gas) to be fully functional. As a result, the vacuum mixing system is less disruptive than conventional vacuum mixing systems and can always be used in mobile applications. The energy needed to generate the negative pressure and/or vacuum is stored in the tensioned compression spring 78 as energy reservoir that can be triggered easily by operating the screw 80. As an alternative to the compression spring 78, a tensioned tension spring or a tensioned gas spring can be used just as well. The design involving a compression spring 78 made of steel is simpler and less expensive and therefore preferred
(29) The features of the invention disclosed in the preceding description and in the claims, figures, and exemplary embodiments, can be essential for the implementation of the various embodiments of the invention both alone and in any combination.
LIST OF REFERENCE NUMBERS
(30) 1, 51 Cartridge system 2 Liquid container 3 Foot part 4, 54 Cartridge 6, 56 Mixing vane 8, 58 Mixing tube 9, 59 Sterilisation plunger 10, 60 Sealing plunger 11, 61 Handle part 12, 62 Connecting conduit/vacuum conduit 14 Liquid conduit 16 Siphon 18, 68 Pump 20, 70 Hollow cylinder 22, 72 Plunger 24, 74 Exit/connector 26, 76 Pumping space 28, 78 Spring 30, 80 Connecting element/screw 32, 82 External thread 33, 83 Internal thread 34, 84 Projection/pin 36, 86 Opening 40 Glass ampoule 42 Head of the glass ampoule 44 Rotating lever 46 Lid 53 Base 87 Rocker lever 90 Thread attachment