Device and method for manually opening glass ampules and a cementing device

Abstract

Devices and methods manually open glass ampules within the devices. One device may include a holder having at least one deformable side wall, a supporting element, and at least one strainer/filter arranged below the holder so that the content of the opened glass ampule may flows therethrough. A first lever of the device may pivot around a first axis and a free end of the first lever may be pressed against the deformable side wall of the holder. A second lever of the device may pivot around a second axis that may divide the second lever into a short lever arm and a long lever arm. The short lever arm may be pressed against the first lever and a glass ampule may be broken open by pressure of the free end of the first lever.

Claims

1. A device for manually opening glass ampules within the device, wherein the device comprises: a holder with side walls closed at least in sections for holding glass ampules, wherein the holder comprises at least one deformable closed side wall and a supporting element located opposite to the at least one deformable closed side wall; at least one selected from a strainer and a filter arranged below the holder so that content of an opened glass ampule is flowable through the at least one selected from the strainer and/or the filter; a first lever pivotable around a first axis such that the first lever rotates against the holder, wherein the first lever has a total length defined between a first end and an opposite second end, wherein the first end comprises the first axis and the second end is a free end of the first lever that is pressable against the deformable closed side wall of the holder; and a second lever pivotable around a second axis such that the second lever rotates against the holder, wherein the second axis divides the second lever into a short lever arm and a long lever arm, wherein one end of the short lever arm is pressable through manual operation of the long lever arm against the first lever such that the free end of the first lever presses against the deformable closed side wall and deforms said deformable closed side wall such that a glass ampule, when located in the holder, is broken open by the pressure of the free end of the first lever.

2. The device according to claim 1, wherein the holder is a hollow cylinder and/or the holder consists of an elastomer or comprises an insertion made of an elastomer.

3. The device according to claim 1, further comprising: a ledge for placing on a glass ampule arranged in the holder, wherein the ledge is smaller than half the area of the surface of the ampule floor or the ampule profile of a glass ampule to be held by the holder.

4. The device according to claim 3, wherein the ledge is arranged in the holder such that a distance between the ledge and the at least one selected from the strainer and the filter is the same as or greater than the outer diameter of the glass ampule to be held by the holder.

5. The device according to claim 3, wherein the ledge is arranged in the holder such that a glass ampule to be held by the holder stands on the ledge such that the free end of the first lever lies above the ampule floor on the outer side of the deformable closed side wall.

6. The device according to claim 1, wherein, when the second lever is operated, the free end of the first lever presses onto the deformable closed side wall such that a vector of a force comprises a component which is oriented in a direction of the at least one selected from the strainer and the filter and/or which presses a glass ampule, to be held in the holder, into the holder in a direction of the ledge.

7. The device according to claim 1, wherein, on the free end of the first lever on a side facing towards the holder, a cutting edge is arranged.

8. The device according to claim 1, wherein the length ratio between the long lever arm and the short lever arm is at least 5 to 1.

9. The device according to claim 1, wherein a glass ampule is arranged in the holder and the glass ampule contains a monomer liquid for producing a medical bone cement, wherein the glass ampule, arranged in the holder, is the glass ampule that is manually openable in the device.

10. The device according to claim 1, wherein the second lever is rotatable in a plane in which the first lever is rotatable, wherein the movement of the second lever engages with the movement of the first lever.

11. The device according to claim 1, wherein the second axis of the second lever is arranged above the first axis of the first lever.

12. A medical cementing device for mixing a PMMA bone cement, the medical cementing device comprising: the device according to claim 1; and a cartridge with a mixing chamber containing a bone cement powder, wherein the mixing chamber is connected with the holder below the at least one selected from the strainer and the filter such that it is permeable to liquids.

13. The medical cementing device according to claim 12, further comprising: a glass ampule arranged in the holder and comprising a monomer liquid; a pump, with which the monomer liquid is to be pumped into the cartridge; a connection line, through which the monomer liquid is to be transported from the glass ampule into the cartridge; a manually operated stirring unit, with which the content of the cartridge can be mixed; a delivery piston which is provided in the cartridge such that it can be moved in the longitudinal direction and by which the mixed bone cement is to be discharged from the cartridge; a gas-permeable connection means in the delivery piston, which connects the interior chamber of the cartridge with the external environment; and a foot element which is connected to the holder, the cartridge and the levers, and with which the cementing device can be placed onto an even surface.

14. The cementing device according to claim 13, wherein the pump is a suction pressure pump, wherein a pressure pump element of the suction pressure pump is connected to the holder and the suction pump element of the suction pressure pump is connected to the mixing chamber of the cartridge.

15. A method comprising: opening a glass ampule positioned within the device, according to claim 1, by manually rotating the long lever arm of the second lever around the second axis.

16. The method according to claim 15, wherein at least one selected from the glass ampule is inserted into the holder prior to the manual operation of the second lever and the glass ampule is inserted with an ampule floor of the glass ampule inserted first into the holder.

17. The method according to claim 15, wherein, following the opening of the glass ampule, a monomer liquid runs out of the glass ampule through the at least one selected from the strainer and the filter and is transported into a mixing chamber of the cartridge in which a bone cement powder is located, wherein subsequently, the bone cement powder and the monomer liquid are mixed in the mixing chamber of the cartridge.

18. The device according to claim 2, wherein the elastomer has a shore hardness of greater than 60 and the elastomer is a silicon rubber or an ethylene propylene diene rubber.

19. The medical cementing device according to claim 13, wherein the pump is a suction pressure pump, wherein the pressure pump element of the suction pressure pump is connected to the holder and the suction pump element of the suction pressure pump is connected to the mixing chamber of the cartridge via the gas-permeable connection means in the delivery piston.

20. A device for manually opening a glass ampule held within the device, the device comprising: a holder with side walls closed at least in sections, wherein the holder comprises at least one deformable closed side wall and a supporting element located opposite to the at least one deformable closed side wall; at least one selected from a strainer and a filter arranged below the holder; a first lever pivotable around a first axis such that the first lever rotates against the holder, wherein the first lever comprises a free end that is pressable against the deformable closed side wall of the holder; and a second lever pivotable around a second axis such that the second lever rotates against the holder, wherein the second axis divides the second lever into a short lever arm and a long lever arm, wherein the free end of the first lever has a total thickness defined between a first side of the free end and an opposite second side of the free end, wherein the first side of free end faces the at least one deformable closed side wall of the holder and the opposite second side of the free end faces the short lever arm of the second lever, and the total thickness of the free end is disposed between the deformable closed side wall and short lever arm of the second lever.

Description

(1) Below, further exemplary embodiments of the invention will be explained with reference to five schematic drawings, although without at the same time restricting the invention, in which:

(2) FIG. 1: shows a schematic side view of a cementing device according to the invention with a device according to the invention for opening glass ampules;

(3) FIG. 2: shows a schematic profile view of the cementing device according to FIG. 1;

(4) FIG. 3: shows a schematic detail profile view of the device according to the invention for opening glass ampules as a part of the cementing device as shown in FIGS. 1 and 2 before breaking open the glass ampule;

(5) FIG. 4: shows a schematic detail profile view of the device according to the invention for opening glass ampules as shown in FIG. 3 after the glass ampule has been broken open; and

(6) FIG. 5: shows a schematic perspective profile view of a part of the cementing device as shown in FIGS. 1 and 2.

(7) FIGS. 1 to 5 show different views of a cementing device according to the invention and a device for opening glass ampules according to the invention as part of said cementing device. FIG. 1 shows a schematic side view of a cementing device according to the invention with a device for opening glass ampules according to the invention. The cementing device comprises an ampule holder 1, which is closed on the upper side (in FIG. 1 above) with a lid 2. In the interior of the ampule holder 1, a glass ampule (not shown in FIG. 1) is contained which can be opened within the ampule holder 1 or within the device for opening the glass ampule. The lid 2 can simply be inserted into the ampule holder 1 in order to close the inner chamber of the ampule holder 1. Next to the ampule holder 1, a lever 4 is provided which ends in a grip 6. The lever 4 can be manually turned or tipped against the ampule holder 1 with the aid of the grip 6 in the direction away from the ampule holder 1 and the lid 2 in order to operate the cementing device or the device for opening the glass ampule.

(8) Furthermore, a cartridge 8 is arranged next to the ampule holder 1, in which a bone cement powder is arranged. A mixing tube 10 which ends in a grip 12 protrudes into a mixing chamber of the cartridge 8, which is formed by the inner chamber of the cartridge 8. The mixing tube 10 is additionally supported in such a manner that it is rotatable and displaceable in the longitudinal direction, in a passage which leads into the interior of the cartridge 8.

(9) The lever 4 is supported in such a manner that it can be turned against the ampule holder 1 within a housing 14. The housing 14, the grips 6, 12, the mixing rod 10, the cartridge 8, the lever 4, the lid 2 and the ampule holder 1 are made of plastic and can be produced using a simple injection moulding method. The ampule holder 1 ends in a connection line 16, which connects the ampule holder 1 with the mixing chamber of the cartridge 8 in a fluid-permeable manner. The connection line 16 forms a loop 18 or a siphon 18 to prevent a fluid from flowing out of the opened glass ampule in the ampule holder 1 and into the mixing chamber of the cartridge 8 directly after the glass ampule has been opened. The connection line 16 is transparent and can be observed by the user through a window in the housing in the area of the loop 18. As a result, the user has the opportunity of visually checking whether the fluid is being guided into the mixing chamber of the cartridge 8. Additionally, a scale can be provided in the area of the window with which the user can check the quantity of the fluid that has been introduced or is present in the ampule holder 1.

(10) The ampule holder 1, the housing 14 and the cartridge 8 are supported by a foot element 20 made of plastic. The foot element 20 can be designed as a single piece with the ampule holder 1 and the housing 14. The foot element 20 has an even underside, so that the cementing device can be set conveniently on an even base, such as a table. In the foot element 20, a connecting piece 22 is arranged for clamping and affixing the cartridge 8.

(11) A sealing piston 24 as part of a two-part delivery piston is arranged around the mixing tube 10. The mixing tube 10 extends in the longitudinal direction through a passage in the sealing piston 24 in such a manner that it can be pivoted and displaced. A circumferential seal 26 made of rubber is arranged on the sealing piston 24, with which the sealing piston 24 can be sealed against a sterilization piston (not shown in FIG. 1, but shown in FIGS. 2 to 5) as a second part of the delivery piston when the sealing piston 24 is inserted into the sterilization piston. The sterilization piston is already inserted above in the cartridge 8 and closes the mixing chamber of the cartridge 8 against the environment in a gas-permeable manner, while being impermeable for the bone cement powder. The sealing piston 24 and the sterilisation piston can be produced from plastic with the exception of the seal 26 and the seals of the sterilization piston.

(12) FIG. 2 shows a schematic profile view of the cementing device as shown in FIG. 1. Here, it can be seen that in the interior of the ampule holder 1, a glass ampule 30 is located. The glass ampule 30 is filled with a monomer fluid. FIG. 3 shows a schematic detail profile view of the device according to the invention for opening glass ampules as part of the cementing device as shown in FIGS. 1 and 2 prior to breaking open the glass ampule 30. The monomer fluid forms a bone cement mixture with the cement powder from the cartridge 8 when they are mixed together. The glass ampule 30 comprises an ampule head 32 which is usually broken off in order to open the glass ampule 30. Since the glass ampule 30 has a thin neck, this causes the monomer fluid to flow out of the glass ampule 30 only slowly, and thus the user must wait until they can implement the next steps for operating the cementing device.

(13) The glass ampule 30 is inserted in an insert 34 made of a deformable material. The insert 34, together with the ampule holder 1, forms a holder 1, 34 for the glass ampule 30. The insert 34 is designed with several thickened areas in the lower section, which form a ledge 36, on which the ampule floor sits. The ampule floor is located on the side of the glass ampule 30 opposite the ampule head 32. The glass ampule 30 can therefore only be inserted into the insert of the ampule holder 1 up to the ampule floor.

(14) The ampule holder 1 comprises a side opening, in which the insert 34 forms a deformable side wall 38. At this point, the glass ampule 30 can be opened or broken open, whereby a pressure acts through the deformable side wall 38 onto the glass ampule 30 just above the ampule floor. When the ampule floor of the glass ampule 30 is broken off or when the glass ampule 30 is opened, the monomer fluid can flow in the full profile out of the opened glass ampule 30, so that the monomer fluid is quickly available to its full extent for further processing within the cementing device or within the device for opening the glass ampule 30 of the cementing device.

(15) In order to deform the side wall 38 and thus to break open the glass ampule 30, the lever 4 is used, which is operated via the grip 6 and turned around an axis 40. The lever 4 is supported against the housing 14 in such a manner that it can be pivoted or turned around the axis 40. The axis 40 divides the lever 4 into a long lever arm 42 on which the grip 6 is affixed and a short lever arm 44 which is arranged within the housing 14. As presented, the long lever arm 42 can only be moved away from the ampule holder 1 and not towards it, since the short lever arm 44 on the foot element 20 or the housing 14 lies in contact on the side opposite the ampule holder 1 (in FIGS. 2 and 3, right), and thus blocks a rotation in this direction.

(16) The short lever arm 44 of the lever 4 lies on its side facing the ampule holder 1 in contact with a further shorter lever 46, which is connected via a joint 48 or an axis 48 such that it can be pivoted around the axis 48 with the foot element of the cementing device or the device for opening the glass ampule 30. This additional lever 46 is arranged within the housing 14. The free lever end 50 of the lever 46 in the housing 14 can be moved with the short lever arm 44. At the tip of the free lever end 50, a cutting edge 52 is attached which lies in contact on the deformable side wall 38. The axis 48 of the lever 46 is here arranged in such a manner that the free lever end 50 and thus the cutting edge 52 moves in the direction of the deformable side wall 38 and the foot element 20. As a result, it is achieved that the force which can be applied by the cutting edge 52 through the deformable side wall 38 onto the glass ampule 30, also lightly presses the glass ampule 30 in the direction of the ledge 36 and thus presses the glass ampule 30 into the holder 1, 34.

(17) Below the ledge 36, a strainer 54 and/or a filter 54 is arranged with which glass splinters from the opened or broken open glass ampule 30 can be withheld. The distance between the ledge 36 and the strainer 54 and/or filter 54 is greater than the outer diameter of the glass ampule 30, so that the ampule floor which falls off can turn in the interim chamber and does not prevent the outflow of the monomer fluid from the opened glass ampule 30. Below and strainer 54 and/or the filter 54, a funnel 56 is arranged which ends in the connection line 16. Additionally, a valve element (not shown) can also be provided at the entrance of the holder 1, 34 into the connection line 16 which can be opened or closed with the aid of a turning lever.

(18) The connection line 16 guides the monomer fluid over the loop 18 to the cartridge 8. In the mouth of the connection line 16 into the cartridge 8, a powder-impermeable but for monomer fluid-permeable filter 58 is arranged. This filter 58 prevents cement powder from entering into the connection line 16 from the mixing chamber of the cartridge 8, reacting with the monomer fluid there and then hardening in the connection line 16 and as a result blocking the connection line even before the monomer fluid has been guided into the cartridge 8 either completely or in the quantity required. The filter 58 is provided in a connecting piece 60 with an external thread. The cartridge 8, which comprises a matching internal thread, is bolted onto said connecting piece 60.

(19) On the upper end of the cartridge 8, the sterilisation piston 62 is arranged inside the cartridge, and is sealed against the inner walls of the cartridge 8 with two circumferential sealing rings 64 made of rubber. The sterilisation piston 62 is gas-permeable, so that via the sterilisation piston 62, the interior of the cartridge 8, i.e. the mixing chamber, can be sterilised with a sterilising gas such as ethylene oxide. The sterilisation piston 62 provides an upward boundary of the mixing chamber in the interior of the cartridge 8. The sterilisation piston 62 can be moved in the longitudinal direction within the cartridge 8 (shown in FIG. 2 from top to bottom) in order to force out the finished cement mixture from the cartridge 8. In the position shown in FIG. 2, the sterilisation piston 62 is arrested, however, in order to prevent an unwanted movement of the sterilisation piston 62. The sealing piston 24 and the sterilisation piston 62 together form a two-part delivery piston 24, 62 for forcing out the content from the cartridge 8. The sealing piston 24 can be inserted into the sterilisation piston 62 from above in order to seal off the piston system 24, 62 or delivery piston 24, 62. In the sealing piston 24, a passage 66 is located for connecting a vacuum source. With the vacuum source, the mixing chamber in the cartridge 8 can be evacuated and additionally, the monomer fluid can be suctioned out of the ampule holder 1 or the connection line 16 into the cartridge 8.

(20) In the interior of the cartridge 8, i.e. in the mixing chamber, a mixing facility is located with several mixing paddles 68 which are attached to the mixing tube 10. In the mixing tube, a rod 70 is located for stabilisation purposes. With the mixing tube 10, the mixing facility or mixing paddles 68 can be turned in the mixing chamber and moved in the longitudinal direction (shown in FIG. 2 from top to bottom) in order to thoroughly mix the content of the cartridge 8 or the monomer fluid with the cement powder. In order to ensure that the monomer fluid can flow well out of the ampule holder 1, a ventilation passage 72 is provided in the lid 2 through which the air can subsequently flow into the ampule holder 1 when the monomer fluid is guided via the funnel 56 and the connection line 16 into the cartridge 8. In the area of the inner wall of the insert 34, grooves can be provided for this purpose, through which the air can subsequently flow past the glass ampule 30.

(21) FIG. 4 shows a schematic detailed profile view of the device according to the invention for opening glass ampules as shown in FIG. 3 after the glass ampule 30 has been broken open, and FIG. 5 shows a schematic-perspective profile view of a part of the cementing device as shown in FIGS. 1 and 2 with an opened glass ampule 30. The ampule floor 74 is broken off from the glass ampule 30 and thus the glass ampule 30 in the cementing device or device for opening the glass ampule 30 is opened. Additionally, the lever 4 has been manually tipped so that the smaller lever 46 in the interior of the housing 14 with the cutting edge 52 has pressed onto the deformable side wall 38 until the ampule floor 74 has been broken off.

(22) In order to prevent the ampule holder 1 on the side opposite the deformable side wall 38 from being too lightly deformed due to the force effect via the lower lever 46, a supporting element is provided which in the present example is formed by the housing, which surrounds the loop 18 of the connection line 16 and which is designed as a single part with the ampule holder 1. The ampule holder 1 itself can however easily form the supporting element. For this purpose, the ampule holder 1 must merely be sufficiently stable, i.e. comprise e.g. a sufficient wall thickness so that the walls of the ampule holder 1 located opposite the deformable side wall 38 cannot be deformed due to the pressure exerted by the lever 46 and transmitted by the cutting edge 52 and the glass ampule 30.

(23) The monomer fluid from the glass ampule 30 runs out and can be used for mixing with the cement powder in the cartridge 8. After the glass ampule 30 has been broken open, the monomer fluid is available in the ampule holder 1 and can be guided through the connection line 16 into the inner chamber of the cartridge 8, in which a low pressure in the inner chamber of the cartridge 8 is used in order to suction the monomer fluid out of the ampule holder 1 into the inner chamber of the cartridge 8. This low pressure can be generated by a pump (not shown). Alternatively, the monomer fluid can also be pressed into the cartridge 8 with a suitable structure (a pressure pump). In the inner chamber of the cartridge 8, the monomer fluid can then be mixed with the cement powder with the mixing paddles 68 under vacuum conditions or subjected to low pressure, in order to generate the bone cement or bone cement paste.

(24) When the initial components in the inner chamber of the cartridge 8 are mixed with the mixing paddles 68, the mixing tube 10 is pulled out upwards as far as possible from the inner chamber of the cartridge 8 and can then be broken off at a set breakpoint. The sealing piston 24 is turned against the sterilisation piston 62 and thus the gas passage through the sealing piston 24 is closed. The vacuum source is separated from the sealing piston 24. The cartridge 8 is unscrewed from the foot element 20 and a discharge tube (not shown) is screwed into the interior thread of the cartridge 8, through which the mixed bone cement can be applied. The supply piston 24, 62, which is composed of the sterilisation piston 62 and the sealing piston 24, is unlatched and can be driven with an application device (not shown) into the interior of the cartridge 8. As a result, the contents of the cartridge 8, i.e. the mixed bone cement, are pressed out from the opposite opening and through the screwed-on discharge tube.

(25) The components of the cementing device can be made of plastic using an injection moulding method with the exception of the glass ampule 30, the filter 58 and the initial components of the bone cement. The conduits 16, 18 can be made from a different plastic material.

(26) With the cementing device described, the two initial components of the bone cement can be stored and mixed under vacuum conditions at any later point in time required. No internal energy storage device such as a battery or tensioned spring is required for opening the glass ampule 30. The energy required to do so is manually applied.

(27) The features of the invention disclosed in the above description and in the claims, figures and exemplary embodiments can be essential both individually and in any combination required for the realisation of the invention in its different embodiments.

LIST OF REFERENCE NUMERALS

(28) 1 Ampule holder 2 Lid 4 Lever 6 Grip 8 Cartridge 10 Mixing tube 12 Grip 14 Housing 16 Connection line 18 Loop/siphon 20 Foot element 22 Connecting piece 24 Sealing piston 26 Seal 30 Glass ampule 32 Ampule head 34 Insert 36 Ledge 38 Deformable side wall 40 Rotational axis/bearing 42 Long lever arm 44 Short lever arm 46 Lever 48 Rotational axis/bearing 50 Free lever end 52 Edge 54 Strainer/filter 56 Funnel 58 Powder impermeable and fluid-permeable filter 60 Connecting piece with external thread 62 Sterilisation piston 64 Seal 66 Passage 68 Mixing paddles 70 Rod 72 Ventilation passage 74 Ampule floor