MIXING AND DISPENSING SYSTEM AND METHOD OF MIXING AND DISPENSING MATERIAL FROM A MIXING AND DISPENSING SYSTEM
20210129096 · 2021-05-06
Inventors
- Benjamin NIEBER (Eschenbach, CH)
- Joseph MOSER (Künten, CH)
- Beat MATHYS (Muri, CH)
- Martin VEID (Weggis, DE)
Cpc classification
B01F35/752
PERFORMING OPERATIONS; TRANSPORTING
B01F35/71801
PERFORMING OPERATIONS; TRANSPORTING
B01F35/7161
PERFORMING OPERATIONS; TRANSPORTING
A61B17/8833
HUMAN NECESSITIES
B01F33/50112
PERFORMING OPERATIONS; TRANSPORTING
B01F35/7131
PERFORMING OPERATIONS; TRANSPORTING
B01F35/3204
PERFORMING OPERATIONS; TRANSPORTING
B01F31/40
PERFORMING OPERATIONS; TRANSPORTING
B01F35/7174
PERFORMING OPERATIONS; TRANSPORTING
B01F2101/20
PERFORMING OPERATIONS; TRANSPORTING
B01F35/754251
PERFORMING OPERATIONS; TRANSPORTING
International classification
A61B17/88
HUMAN NECESSITIES
Abstract
A mixing and dispensing system for a two-component material, such as a bone cement, the mixing and dispensing system including a handle connected to the mixer via a mixing shaft. The mixing shaft extends through the piston from the piston driving end in the direction of the outlet end in order to move the mixer in dependence on movements initiated via the handle, and with the handle being detachable, in particular in a non-destructive manner, from the mixing shaft via a connector.
Claims
1. A mixing and dispensing system for a two-component material, such as a bone cement, the mixing and dispensing system comprising: a cartridge having a piston driving end and an outlet end and a chamber formed therebetween for storage of at least a first component of the two-component material; a piston arranged moveable to and fro between the piston driving end and the outlet end and stored initially at the piston driving end; a mixer arranged within the chamber between the piston and the outlet end, the mixer being moveable relative to the piston and the chamber; and a handle connected to the mixer via a mixing shaft, the mixing shaft extending through the piston from the piston driving end in a direction of the outlet end in order to move the mixer in dependence on movements initiated via the handle, and the handle being detachable from the mixing shaft via a connector.
2. The mixing and dispensing system according to claim 1, wherein the handle comprises a rod and the rod is detachable from the mixing shaft via said connector.
3. The mixing and dispensing system according to claim 1, wherein the connector is part of a drive interface for applying translational as well as rotational forces at the mixer via said rod and mixing shaft, such as a drive interface formed by a tight fit respectively a force fit.
4. The mixing and dispensing system according to claim 2, wherein the rod comprises elements more flexible than the mixing shaft at the connector.
5. The mixing and dispensing system according to claim 4, wherein the connector comprises one or more buttons capable of being depressed to disengage the handle from the mixing shaft.
6. The mixing and dispensing system according to claim 1, wherein the connector is arranged outside of the cartridge.
7. The mixing and dispensing system according to claim 2, wherein the rod extends from the handle beyond the connector towards the mixer within said mixing shaft.
8. The mixing and dispensing system according to claim 1, wherein the handle is arranged at least substantially perpendicular to the mixing shaft.
9. The mixing and dispensing system according to claim 1, wherein the mixing shaft is journaled by said piston.
10. The mixing and dispensing system according to claim 2, wherein the rod is journaled by said mixing shaft.
11. The mixing and dispensing system according to claim 1, wherein the mixer is moveable axially along a longitudinal axis between the piston and the outlet end and is rotatable about the longitudinal axis.
12. The mixing and dispensing system according to claim 1, wherein the piston is releasably locked in a storage position at the piston driving end prior to mixing with said mixer, and the piston is moveable via a dispensing mechanism following the release of the piston from the storage position for dispensing said two-component material from said cartridge.
13. The mixing and dispensing system according to claim 1, wherein the mixer comprises two or more vanes extending radially outward from the mixing shaft.
14. The mixing and dispensing system according to claim 1, wherein the mixer comprises two or more vanes extending radially outward from the mixing shaft, said two or more vanes being connected to an outer ring.
15. The mixing and dispensing system according to claim 1, wherein the outlet end comprises a first interface via which an ampoule container and a dispensing outlet are capable of being releasably connected to the cartridge; or the piston driving end comprises a second interface via which a dispensing mechanism is capable of being connected to the cartridge after the handle has been removed from the mixing shaft.
16. A method of mixing and dispensing material from a mixing and dispensing system, the mixing and dispensing system comprising a cartridge having a piston driving end and an outlet end and a chamber formed therebetween for storage of at least a first component of the two-component material, a piston arranged moveable to and fro between the piston driving end and the outlet end and stored initially at the piston driving end, a mixer arranged within the chamber between the piston and the outlet end, the mixer being moveable relative to the piston and the chamber, and a handle connected to the mixer via a mixing shaft, the mixing shaft extending through the piston from the piston driving end in the direction of the outlet end, the method comprising: moving the mixer in dependence on movements initiated via the handle; and detaching the handle from the mixing shaft via a connector.
17. The mixing and dispensing system according to claim 4, wherein the connector comprises one or more buttons capable of being depressed to disengage the handle from the mixing shaft, the one or more buttons being connected to the elements more flexible than the mixing shaft.
18. The mixing and dispensing system according to claim 12, wherein the dispensing mechanism is a threaded dispenser.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The invention will be explained in more detail hereinafter with reference to the drawings.
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
DETAILED DESCRIPTION
[0045] In the following the same reference numerals will be used for parts having the same or equivalent function. Any statements made having regard to the direction of a component are made relative to the position shown in the drawing and can naturally vary in the actual position of application.
[0046]
[0047] The mixing and dispensing system 10 comprises a cartridge 12 for storage of a first component M′ of the two-component material M′, M″, the cartridge 12 comprising a mixer 14 arranged therein.
[0048] An ampoule container 16 for receiving an ampoule 18 comprising a second component M″ of the two-component material M′, M″ is connected to the cartridge 12 via a first interface 20. The first interface 20 is configured to releasably connect and disconnect the cartridge 12 with and from said ampoule container 16. A longitudinal axis A extends between said cartridge 12 and said ampoule container 16 and through said first interface 20.
[0049] The ampoule container 16 further comprises an activation element 24. On moving said activation element 24 from a storage position into an activated position, a part 26 of said activation element 24 moves perpendicular to said longitudinal axis A such that the part 26 contacts a top 32 of said ampoule 18 for opening said ampoule 18 when said activation element 24 is displaced from the storage position into the activated position. Thereby the second component M″ stored in said ampoule 18 can be released from said ampoule 18 into said cartridge 12 to come into contact with said first component M′ stored in said cartridge 12 for mixing the two-component material M′, M″ in said cartridge 12 with said mixer 14.
[0050] The activation element 24 is arranged partly at an outer wall 28 of the ampoule container 16. More specifically a rotatable switch 30, such as a half turn coupling 30′, of the activation element 24 is arranged at the outer wall 28. The activation element 24 further comprises an activation plunger 26′ arranged within said ampoule container 16. The activation plunger 26′ is configured to contact the top 32 of said ampoule 18 for opening said ampoule 18 when said activation element 24 is displaced from the storage position into the activated position.
[0051] In this connection also a quarter turn coupling or the like would be feasible to activate the activation plunger 26′.
[0052] In order to displace the activation plunger 26′ from the storage position into the activated position, the rotatable switch 30 is rotated about an axis of rotation R to produce an axial movement of said activation plunger 26′ along said axis of rotation R of said rotatable switch 30.
[0053] A vacuum port 22 is also arranged at the ampoule container 16 for providing a vacuum within the mixing and dispensing system 10. The vacuum port 22 is arranged remote from the activation element 24 in such a way that it does not come into contact with the rotatable switch 30 on rotating the rotatable switch 30 about the axis of rotation R.
[0054] On mixing two-component material M′, M″, such as cement M, M″, e.g. PMMA (poly-methyl methacrylate) used e.g. in joint replacement surgery, such as hip replacement surgery, cracks in the cement mantle may facilitate a mechanical loosening of the prosthesis. In order to avoid this a vacuum is applied on mixing the cement M′, M″ in the cartridge 12 to reduce the cement porosity of the cement such that less cracks, pores etc. are formed in the cement and particularly its mantle.
[0055] In this connection it should be noted that the cartridge 12 should be sealed off to the outside during the mixing of the two-component material M′, M″, such that a contamination or the like of the two-component material M′, M″ can be avoided.
[0056] For this purpose the vacuum port 22 is arranged at the outer wall 28 of the ampoule container 16 such that it can evacuate a chamber 50 of the cartridge 12 formed between a piston driving end 46 and an outlet end 48 of the cartridge 12.
[0057] In order to evacuate the chamber 50, a groove 96, in particular an L-shaped groove 96, leads from the vacuum port 22 to the chamber 50 through the first interface 20 to the cartridge 12. The vacuum port 22 can be connected to a source of vacuum (not shown) via a vacuum line 98 in a manner known per se.
[0058] In this connection it should be noted that a corresponding passage or groove can also be provided extending from the vacuum port 22 to the chamber 50 if the vacuum port 22 is arranged at the cartridge 12 rather than at the ampoule container 16.
[0059] It should further be noted in this connection that it is preferred to have the vacuum port 22 at the ampoule container 16 since this makes the handling of the cartridge 12 simpler after mixing and disconnecting of the ampoule container 16, since no vacuum port 22 would then be present at the cartridge 12.
[0060] The mixer 14 is also arranged within the chamber 50 between the piston 34 and the outlet end 48, with the mixer 14 being moveable relative to the piston 34 and the chamber 50 during mixing of the cement M′, M″. The mixer 14 can be moved radially about said longitudinal axis A and axially along said longitudinal axis A for mixing said two-component material M′, M″.
[0061] A piston 34 is arranged moveable to and fro between the piston driving end 46 and the outlet end 48 of the cartridge and is stored initially at the piston driving end 46. The piston 34 is pre-positioned within the cartridge 12 such that once a force above a threshold pressure is applied on the piston 34, the piston 34 can dispense the mixed two-component material M′, M″ from the cartridge. Such forces can typically be selected in the range of 100 to 3000 N.
[0062] The piston 34 may be moveable via a threaded dispenser 40 (see
[0063] Once the ampoule 18 has been opened the second component M″ stored therein is moved into the cartridge 12 via a passage 100 arranged at the ampoule container 16 for mixing in the chamber 50.
[0064] In order to avoid glass splinters (not shown) from being moved together with the second component M″ into the cartridge 12, a net 102 is arranged around the top 32 of the ampoule 18.
[0065] A cap 106 can be placed onto the end 104 of the ampoule container 16 remote from the end 108 present at the first interface 20. The cap 106 can act as a stand for the ampoule container 16, such that on storing and/or activating the mixing and dispensing system 10, the mixing and dispensing system 10 can stand on a surface via this cap 106.
[0066] A part 36, more specifically a rod 36′, of the mixer 14 is detachable via a connector 38 of a drive interface 38′, in such a way that the threaded dispenser 40 of a dispensing mechanism 40′ (see
[0067] The mixer 14 is connected to a handle 52 via a mixing shaft 54 and the rod 36′. The mixing shaft 54 extends between the handle 52 and the mixer 14 and passes through the piston 34 via a piston passage 56 such that the mixer 14 can be moved in dependence on movements initiated via the handle 52 and indeed relative to the piston 34 and the chamber 50.
[0068] The handle 52 is detachable, in particular in a non-destructive manner, from the mixing shaft 54 via the connector 38. In this connection it should be noted that the handle 52 can also be removed without the use of tools, i.e. in a tool-free manner.
[0069] On storing the mixing and dispensing system 10, the handle 52 and part of the mixing shaft 54 are stored in a stand 110 that comprises respective grooves 112, 114 for receiving and storing the handle 52 and part of the mixing shaft 54. An end 118 of the stand is arranged adjacent to the piston driving end 46 in the storage state of the mixing and dispensing system 10. As indicated in
[0070] In this connection it should be noted that the precise position of the mixer 14 within the cartridge 12 is not pre-defined in the storage state of the mixing and dispensing system 10, the stand 110 should merely ensure that the mixer 14 does not move in the storage state of the mixing and dispensing system 10.
[0071]
[0072] To form the first interface 20 an outer surface 120 of the cartridge 12 comprises pins 122 extending radially therefrom. The pins 122 engage matching slots 124 (see also
[0073] A distance between the cap 126 and the activation element 24 shown is such that the switch 30 can be rotated by at most approximately 270° relative to the ampoule container 16. This means that a distance the activation plunger 26′ can travel between the storage position and the activation position has to be achieved by at most a 270° degree turn of the rotatable switch 30, with the illustrated design of the rotatable switch 30.
[0074] If more turns are desired then a distance between the cap 126 and the rotatable switch 30 has to be increased, such that these components do not interfere with one another.
[0075] Additionally or alternatively, the activation element 24 could be snap fit into place and the rotation thereof can be used solely for displacing the activation plunger 26′ along the axis of rotation R.
[0076] In the present instance, it has been found to be prudent to use a half turn coupling as the rotatable switch 30 as in this way one achieves a maximum distance the plunger 26′ can travel in a well-defined manner through a minimum rotation of the rotatable switch 30 to achieve the opening of an ampoule 18 stored in the ampoule container 16.
[0077]
[0078] As is further evident in the sectional drawing indicated in
[0079] The plunger 26′ projects from within the rotatable switch 30 through the outer wall 28 of the ampoule container 16 via the hollow projection 136, so that a tip 26″ of the plunger 26′ can contact the top 32 of the ampoule 18 above a neck 140 of the ampoule 18 in order to break and/or open the ampoule 18.
[0080] For the purpose of breaking and/or opening the top 32 of the ampoule, the tip 26″ may have a specific shape, such as the frustoconical shape shown in
[0081] In this connection it should be noted that the rotatable switch 30 may be integrally formed together with the plunger 26′ having the tip 26″ as one piece in an injection molding process.
[0082] The specific design of the mixer 14 is also shown in
[0083]
[0084] To connect the handle 52 to the mixing shaft 54, a rod 36′ that is non-releasably connected to the handle 52 projects into said mixing shaft 54 and is thereby journaled by said mixing shaft 54. The rod 36′ extends from the handle 52 beyond the connector 38 towards the mixer 14 within said mixing shaft 54.
[0085] In order to release the handle 52 from the mixing shaft 54, the connector 38 has to be arranged outside of the cartridge 12 for actuation thereof. On releasing the handle 52 two buttons 60 have to be depressed to disengage the handle 52 from the mixing shaft 54.
[0086] This is possible in the present example, since the rod 36′ comprises elements 58 more flexible than the mixing shaft 54 at the connector 38. On pressing the buttons 60, the buttons 66 press the elements 58 such that they deflect inwardly so that the rod 26′ of the handle can disengage from the mixing shaft 54.
[0087] This is made possible, since the elements 58 are able to deflect relative to the mixing shaft 54 and hence are more flexible than the mixing shaft 54, due to less material being provided and the elements 58 therefore being less rigid than the mixing shaft 54.
[0088] Also other methods of releasably and non-destructively releasing the handle 52 from the mixing shaft are possible, for example using threaded components (not shown).
[0089] Part of the second interface 42 is also indicated in
[0090]
[0091]
[0092] For this purpose and as indicated in
[0093]
[0094] The dispensing outlet 44 is releasably connectable to said cartridge 12 via said first interface 20 on removal of said ampoule container 16 (see
[0095] The dispensing mechanism 40′ comprises a sleeve 66 having a first thread 68 arranged at an outer surface 70 thereof for connecting the sleeve 66 to the piston driving end 46 of the cartridge 12. The dispensing mechanism 40′ further comprises a cartridge plunger 72 that can be arranged partly within said sleeve 66, the cartridge plunger 72 being moveable with and relative to said sleeve 66, and the cartridge plunger 72 having a second thread 74 arranged at an outer surface 76 thereof. The second thread 74 can interact with an inner thread 78 present at an inner surface 80 of the sleeve 66. The cartridge plunger 72 comprises an engagement part 82 for rotating at least the cartridge plunger 72 and depending on the state of use of the threaded dispenser 40′ also the sleeve 66.
[0096]
[0097] In this connection it should be noted that the pre-defined threshold can be selected in the range of 0.2 to 1.2 Nm.
[0098] The first holding member 84 is formed at an outer surface 76 of the cartridge plunger 72 and comprises a plurality of teeth 84′. The second holding member 86 is formed at the inner surface 80 of the sleeve 66 and comprises a plurality of cams 86′. The plurality of teeth 84′ and the plurality of cams 86′ are formed complementary to one another.
[0099] The plurality of teeth 84′ are configured to slip over the plurality of cams 86′ when a torque applied at said cartridge plunger 72 exceeds the pre-defined threshold, in a manner similar to a slipper type torque wrench.
[0100] The engagement part 82 is formed as a handle in the embodiment shown. As the case may be the engagement part 82 may comprise a coupling point 152 such as a hexagonal socket for connecting the dispensing mechanism 40′, i.e. the threaded dispenser 40 to a further component, such as a power tool or a hand tool for rotating the cartridge plunger 72.
[0101]
[0102] On moving the sleeve 66 into the cartridge 12 it is configured to release the piston 34 present in said cartridge 12 from a storage position of said piston 34. Once the sleeve 66 has arrived at its final position in the cartridge 12, the cartridge plunger 72 experiences a resistance so that the torque required to turn the cartridge plunger 72 further in the direction of the longitudinal axis A exceeds the pre-defined threshold, whereby the cartridge plunger 72 disengages from the sleeve 66 at the first and second holding members 84, 86 and slips out of engagement from the sleeve 66.
[0103] Then the second thread 74 starts to turn relative to the sleeve 66 in the inner thread 78 present at the inner surface 80 of the sleeve 66. This moves the cartridge plunger 72 further along the longitudinal axis A into the cartridge 12. The cartridge plunger 72 is configured to move the piston 34 present in said cartridge 12 to and fro along the longitudinal axis A of said cartridge 12 once the sleeve 66 has released the piston 34 from the storage position of said piston.
[0104] On releasing the handle 52 from the mixing shaft 54, neither the mixer 14 nor the mixing shaft 54 are removed, the threaded dispenser 40 is moved over the mixing shaft 54, which is received in a passage 92 configured for receiving the mixing shaft 54.
[0105]
[0106]
[0107]
[0108]
[0109] On activating the mixing and dispensing system 10 illustrated in
[0110] To mix the two-component material M′, M″, the mixer is moved via the mixing shaft 54 and handle 52 to and fro along the longitudinal axis A and by rotating the handle 52, the mixer is also rotated about the longitudinal axis A. The vanes 62 and the outer ring 64 bring about a thorough through mixing of the two-component material M′, M″, as the mixer is moved through the chamber 50 and through the two-component material M′, M″.
[0111] It should be noted that the handle 52 and/or the mixing shaft 54 may have a socket, such as the hexagonal socket 150, via which the mixer 14 and the mixing shaft 54 can be set into rotation using e.g. a power tool. In this way more uniform mixing results of the two-component material M′, M″ can possibly be achieved.
[0112] In this connection it should be noted that the vacuum applied via the vacuum port 22 can be applied either before or during opening of the ampoule 18. If the vacuum is applied before breaking of the ampoule 18, this has the advantage that movement of the second component M″ stored in the ampoule 18 into the cartridge 12 can be assisted through the use of the vacuum as soon as the ampoule 18 is open as the vacuum so to say sucks the second component M″ into the cartridge 12.
[0113] Moreover, due to the presence of the vacuum the amount of air and thus pores in the mixed two-component material M′, M″ is significantly reduced, so that less air is present in the mixture reducing the amount of fatigue cracks that may appear in the solidified two-component material M′, M″, leading to improved adhesion results between the two-component material M′, M″ and the surfaces (not shown) between which it is applied.
[0114] Following the mixing of the two-component material M′, M″ with the mixing and dispensing system 10 the handle 52 connected to the mixer 14 via the mixing shaft 54 is detached. For this purpose a user presses the buttons 60 present at the connector 38. By pressing the buttons 60 the elements 58 more flexible than the mixing shaft 54 present at the rod 36′ allow the rod 36′ to disengage from the mixing shaft 54 in the regions of the apertures 55 present in the mixing shaft 54, whereby the rod 36′ can be removed from the mixing shaft 54 to detach the handle 52 from the mixing shaft 54 via the connector 38.
[0115] In order to dispense material from the mixing and dispensing system 10 the user has to remove the ampoule container 16 from the cartridge 12 via the first interface 20. Following which the user can arrange a dispensing outlet 44, such as the dispensing outlet 44 shown in
[0116] Following this the user now has several options to press the mixed two-component material M′, M″ out of the chamber 50 of the cartridge 12. One option is to install an insert (not shown) at the second interface 42, via which a dispensing gun can be connected to the cartridge 12, for dispensing the two-component material M′, M″ from the cartridge 12.
[0117] The other option is to use the dispensing mechanism 40′ discussed in relation to
[0118] In this final position the sleeve 66 experiences a resistance at the cartridge which means that an increased force has to be applied at the cartridge plunger 72 in order to rotate this further. This means that a force above the pre-defined threshold value is applied at the cartridge plunger 72, such that the first holding members 84 slip past the second holding members 86 so that the second thread 74 present at the outer surface outer surface 76 of the plunger can interact with the inner thread 78 present at an inner surface 80 of the sleeve 66.
[0119] The cartridge plunger 72 then comes into contact with the piston 34 for dispensing said two-component material M′, M″ from said cartridge 12. Once the cartridge plunger 72 has slipped past the first and second holding members 84, 86 one rotates only the cartridge plunger 72 via the engagement part 82. The engagement part 82 can be rotated either by hand or using a power tool (not shown) connectable to the engagement part via the coupling point 152.
[0120] On moving the piston 34 via the cartridge plunger 72, the mixer 14 may at least at some point of the dispensing process rest on the piston 34 and be entrained via the piston 34.
[0121] The dispensing mechanism 40′ is designed in a way that allows a fast forwarding at the beginning, i.e. while the sleeve 66 is attached to the cartridge 12 via the second interface 42, and once the torque above a pre-defined threshold is achieved changes over to the cartridge plunger 72 having a lower pitch which transmits higher forces when needed for dispensing the two-component material M′, M″ via the dispensing outlet 44.
[0122] In this connection it should be noted that a material of at least one of the cartridge 12, the ampoule container 16, the cap 126 of the first interface 20, the cap 106 and the stand 110 and of the piston 34 may be polypropylene (PP).
[0123] A material of at least one of the handle 52, the rotatable switch 30, the rod 36′, and the threaded dispenser 40 may be one of PP and polyamide (PA).
[0124] The net 102 and of the membrane 130 may be formed of a thermoplastic elastomer (TPE).
[0125] Using the above mixing and dispensing system 10 a user, such as a medical professional, can minimize exposure to the two-component material M′, M″. If, for example PMMA is used as a Monomer then this Monomer can be disturbing for the respiratory tract. The use of the ampoule container described in the foregoing, the disconnectable handle and the dispensing mechanism 40′ reduces the risk of the medical professional coming into contact with the monomer. Moreover, if the dispensing mechanism 40′ is used one can use the mixing and dispensing system 10 independent of a multiple-use dispensing gun.