The invention relates to a mixing and dispensing system for separately storing and subsequently mixing the various materials and dispensing the mixed materials from a part of the mixing and dispensing system. The invention further relates to a method of mixing and dispensing two-component material.
Mixing and dispensing systems are known to mix two-component materials, such as the ones used in joint replacement surgery. On mixing two-component material, such as cement, 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.
Moreover, the cement is to be used in a sterile environment and may be rather harmful to the user of the mixing and dispensing system which is why the possible contact of the user with the cement prepared in the mixing and dispensing system is not desirable.
For this reason it is an object of the invention to provide a mixing and dispensing system in which the two-component material can be sufficiently mixed, such that no fatigue cracks occur in the solidified two-component material and in which the contact a user of the mixing and dispensing system may have with the two-component material to be mixed can be minimized. Moreover, it is a further object of the invention to make available a simple mixing and dispensing system that can be used swiftly and efficiently in sterile environments during surgical processes.
This object is satisfied in accordance with the subject matter of the respective independent claim. Further embodiments and specific examples of the invention are defined in the dependent claims.
Such a mixing and dispensing system for a two-component material, such as bone cement, may comprise a first container for a first component of the two-component material, a second container for the second component of the two-component material, an interface to which each of the first and second containers are connectable to and removable from, with the interface comprising one or more passages permitting a flow of the material from the first container into the second container following activation of the mixing and dispensing system; a mixer stored in the second container for mixing the two-component material; wherein the second container is configured as a cartridge from which the mixed two-component material can be directly dispensed, and wherein the first and second containers are arranged at the same side of the interface.
By means of such a mixing and dispensing system the two-component material can be sufficiently mixed, such that no fatigue cracks occur in the solidified two-component material.
Moreover, as the components are stored separate from one another in one and the same system a possible contact of the material with a user of the mixing and dispensing system can be minimized as access thereto is restricted.
Moreover, a simple mixing and dispensing system is thereby made available that can be used swiftly and efficiently in sterile environments during surgical processes.
In this connection it should be noted that the interface can be a component used to connect the first container to the second container for conducting material stored in one into the other one, e.g. on the use of vacuum.
The interface may form a platform for the mixing and dispensing system. A simple mixing and dispensing system is thereby made available that can be used swiftly and efficiently in sterile environments during surgical processes, as a person can gold the system while carrying out the mixing.
A surface of the interface opposite to the side of the interface at which the first and second containers are arranged may be at least substantially or substantially flat. In this way a construction height can be reduced and a stability of the system can be increased making an even more simple to use mixing and dispensing system available.
One or more seals may be arranged between the first container and the interface and/or between the second container and the interface. Through the use of such seals the spilling of material can be avoided reducing a possible contact of the material with a user of the mixing and dispensing system can be minimized as access thereto is restricted.
The first and second containers may be arranged in parallel to one another when the first and second containers are connected to the interface. In this way a construction width can be reduced and a stability of the system can be increased making an even more simple to use mixing and dispensing system available.
The first and second containers may be arranged inclined with respect to one another when the first and second containers are connected to the interface. In this way a construction height can be reduced and a stability of the system can be increased making an even more simple to use mixing and dispensing system available. Moreover, the material stored in the first container can be guided more efficiently to the second container.
An inclination of the first container relative to the second container can be selected in the range of 2 to 30° relative to an axis extending between the first and second ends of the second container.
The second container may comprise first and second ends that are oppositely disposed form one another, with the first end optionally being connectable and removable from the interface and the second end optionally comprising a vacuum port. In this way the material stored in the first container can so to say be sucked from the first container through the interface and into the second container for improved mixing results.
The second container may comprise first and second ends that are oppositely disposed form one another, with the first end being optionally connectable and removable from the interface and the second end optionally comprising an outlet. This further reduces the size and components of the mixing and dispensing system making it even more efficient and cost effective in use.
The second container may comprise first and second ends that are oppositely disposed form one another, with the first end optionally being connectable and removable from the interface and wherein the mixer is optionally actuable from the second end. This further reduces the size and components of the mixing and dispensing system making it even more efficient and cost effective in use.
In this connection it should be noted that the outlet can be formed by e.g. a cannula or a nozzle integrated into the second container, attached to the second container or attachable to the second container
The mixer may be actuable via the outlet. This further reduces the size and components of the mixing and dispensing system making it even more efficient and cost effective in use.
At least a part of the mixer may be removable from the second container via the outlet. In this way no moving of the mixed material from the second container into a further container or cartridge is required increasing the ease of use of the mixing and dispensing system.
A dispensing nozzle may be connectable to the second end of the second container. This aids in dispensing of the mixed two-component material.
A plunger may be connectable to the first end of the second container in order to move a piston arranged therein. Such a plunger can be part of a dispenser used to dispense the mixed two-component material.
The first container may be configured to receive one or more ampoules comprising the first material. Such ampoules are beneficially used to store components of adhesives such as a component of PMMA.
The first container may comprise an ampoule breaking system configured to break said one or more ampoules on activation of the mixing and dispensing system. Such systems can be integrated into the mixing and dispensing system to facilitate the operation thereof.
A cap may be connected to the second container. Such a cap may comprise a vacuum port and/or a connector to an outlet or form part of the outlet.
The cap may comprise an interface to a cannula. In this way a size of the mixing and dispensing system can be reduced improving its handling.
The mixer may be guided into the second container via a cannula, in particular wherein, following mixing, the mixer can be removed from the cannula for dispensing the mixed two-component material via the cannula. In this way a size of the mixing and dispensing system can be reduced improving its handling.
According to a further aspect of the invention this relates to a method of mixing and dispensing two-component material, preferably in a mixing and dispensing system as described herein, the method comprising the steps of:
- preparing a first component stored in a first container for mixing; applying a vaccum to a second container;
- guiding a first component from the first container to a second component stored in the second component through the use of said vacuum;
- mixing the first and second component in the second container with a mixer;
- removing the mixer from the second container and dispensing the mixed two-component material via an outlet through which the mixer is guided into the second container.
By way of such a method the handle can be reliably removed from the mixing and dispensing system while the user does not come into contact with the mixed two-component material, such that pre-loaded and sterile mixed two-component materials can be made available in a sterile cartridge which is particularly useful in a medical environment of use.
Further embodiments of the invention are described in the following description of the Figures. The invention will be explained in the following in detail by means of embodiments and with reference to the drawing in which is shown:
- Fig. 1
- view of components of a mixing and dispensing system;
- Fig. 2
- a further view of the mixing and dispensing system with a first and a second container installed at an interface;
- Fig. 3
- a further view of the mixing and dispensing system with the second container arranged at the interface;
- Fig. 4
- a view of the mixing and dispensing system with a handle removed from a cannula arranged at the second container;
- Fig. 5a to d
- various views of the handle ofFigs. 1 to 4;
- Fig. 6a to c
- various views of components of the mixing and dispensing system;
- Fig. 7
- a view of a second kind of first container;
- Fig. 8a to b
- further views of the first container ofFig. 7;
- Fig. 9a to b
- views of internal workings of the first container ofFig. 7.
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.
Fig. 1 shows a view of a mixing and dispensingsystem 10 for a two-component material M, M', such as bone cement, e.g. PMMA (Poly(methyl methacrylate)). the mixing and dispensing system 10 afirst container 12 for storage of a first component respectively material M of the two-component material M, M', asecond container 14 for storage of a second component respectively material M' of the two-component material M, M', aninterface 16 to which each of the first andsecond containers 12, 14 are connectable to and removable from, with theinterface 16 comprising one ormore passages 22 permitting a flow of the material M from thefirst container 12 into thesecond container 14 following activation of the mixing and dispensingsystem 10.
The mixing and dispensingsystem 10 further comprises amixer 24 arranged in thesecond container 14 for mixing the two-component material M, M' following activation of the mixing and dispensingsystem 10.
In this connection it should be noted that thesecond container 14 is thus not only configured for the storage of the second component M', but is also configured as a mixing space in which the mixed two-component material M, M' is mixed and from which the mixed two-component material M, M' can be directly dispensed.
In this connection it should be noted that the material of the first component M originally stored in thefirst container 12 is drawn into thesecond container 14 via thepassage 22 through the application of a vacuum.
To this end avacuum port 26 is arranged at thesecond container 14 via which a negative pressure can be applied at the mixing and dispensingsystem 10 for sucking the first component M into thesecond container 14 for mixing.
Themixer 24 is a manual mixer, i.e. the mixing is conducted manually.
Themixer 24 is connected to ahandle 28 via acannula 30. Themixer 24 can be axially displaced to and fro relative to thesecond container 14 by pushing thehandle 28 towards thesecond container 14 respectively pulling thehandle 28 away from thesecond container 14. In addition themixer 24 can be rotated relative to thesecond container 14 by turning thehandle 28 relative to thesecond container 14. Thereby both an axial and radial mixing of the two-component material M, M' can be effected.
Thecannula 30 is guided via acap 34 and asupport 32 in order to effect the axial and rotational movement relative to thesecond container 14.
In this connection it should be noted that thesupport 32 can be a port, i.e. a connection interface to a further cannula (not shown). This connection interface can have a thread as part of a connection interface to a counter thread of the further cannula. The connection interface could also be formed as part of a bayonet type connector, of a snap fit connector and/or of connectors used in the medical field.
Thehandle 28 is formed as a T-shaped handle for ease of gripping and effecting the mixing of the two-component material M, M' in the mixing and dispensingsystem 10.
Thehandle 28 is connected to themixer 24 via thecannula 30 and ahub 38 that connects to a connection interface, such as ahub connector 40 of thecannula 30.
In this connection it should be noted that thefirst container interface 18 and/or thesecond container interface 20 engage a respective counterpart 18', 20' at thefirst container 12 and thesecond container 14.
Thefirst container interface 18 and/or thesecond container interface 20 can respectively be formed as one of a threaded connection, a snap-fit connection, a bayonet-type connection, a plug and rotate type connection and/or further types of connection that permit connection to and removal from the first and/or thesecond container 12, 14 with theinterface 16.
Fig. 2 shows a further view of the mixing and dispensingsystem 10 with the first and thesecond container 12, 14 installed at theinterface 16. The mixing and dispensingsystem 10 is in a pre-activation state of use, i.e. prior to permitting the material M stored int ehfirst container 12 to move into thesecond container 14 for mixing.
Fig. 3 shows a further view of the mixing and dispensingsystem 10 with only thesecond container 14 arranged at theinterface 16. This is in a state where the first material M has been moved into thesecond container 14 for mixing with the second material M' prior to mixing the two-component material M, M'.
Fig. 4 shows a view of the mixing and dispensingsystem 10 with thehandle 28 removed from thecannula 30 arranged at thesecond container 14.
In this connection it should be noted that themixer 24 can comprise a plurality ofvanes 46, e.g. 3 to 12 vanes that extend radially outwardly from ahub 50 connect to an end of thecannula 30 arranged at an end of thecannula 30 disposed opposite to thehandle 24, i.e. at aconnector end 42 of the mixingshaft 36.
Thevanes 46 in turn connect to anouter ring 48 that stabilizes thevanes 46 on the one hand, and on the other hand, also allows to scrape the material M, M' from aninner sidewall 44 of thesecond container 14 for thorough through mixing.
In this connection it should be noted that also other kinds ofmixers 28 can be used that can be disengaged from the mixingshaft 36 after mixing for removal of the mixingshaft 36 from thecannula 30.
Following mixing of the two-component material M, M' the mixingshaft 36 is removed from thecannula 30 by disengaging thehub 38 from the mixingshaft 36 via themixer connector 42 as is indicated on the right inFig. 4.
The handle is detachable, in particular in a non-destructive manner, from themixer 24 and thecannula 30. In this connection it should be noted that the mixingshaft 36 supports the cannula during mixing and blocks material M, M' from entering thecannula 30 via theend 42 as this fills thehollow hub 50 of thehollow cannula 30.
Figs. 5a to d show various views of thehandle 28 ofFigs. 1 to 4.Fig. 5a shows thehandle 28 connected to thecannula 30 in the storage state respectively the mixing state, i.e. in a state where movements of thehandle 28 are transferred to movements of themixer 24.
For this purpose thehub 38 comprises anattachment mechanism 52 configured to engage thehub connector 40. By way of example and as shown inFigs. 5b and 5c theattachment mechanism 52 can comprise arms 52' that engage thehub connector 40. In order to do so thehub connector 40 of the cannula has a hexagonal outer shape formed by projections 54 (seeFig. 5c) projecting from anouter surface 56 of thecannula 30 behind which the arms 52' can engage.
When thehub 38 is in the position shown inFig. 5a, the arms 52' are locked in position relative to thehub connector 40 to fix thehandle 28 to thecannula 30. Due to the hexagonal shape of thehub connector 40 and complementary shaped arms 52' the axial and rotational movements induced at thehandle 28 can be transferred to themixer 24.
On axially moving thehub 38 towards thehandle 28 theattachment mechanism 52 is disengagable from thehub connector 40, as the arms 52' are moveable relative to the mixingshaft 36.
Further axial movement of thehandle 28 and thehub 38 away from thesecond container 14 allows the removal of the handle and of the mixingshaft 36 from thecannula 30 as indicated inFig. 5c.
Fig. 5d shows a section taken along the sectional line A:A ofFig. 5a. The outer shape of the mixingshaft 36 that is integrally formed with thehandle 28 is shaped complementary to an inner shape of thecannula 30.
Visible is also the hexagonal shape of thehub connector 40 of thecannula 30 at the position of thehub connector 40.
In this connection it should be noted that the outer shape of the cannula between themixer 24 and thehub connector 40 is generally cylindrical in shape, e.g. at least 90% of a length of thecannula 30 between themixer 24 and thehub connector 40 is cylindrical, preferably at least 95%, especially at least 98% of a length of thecannula 30 between themixer 24 and thehub connector 40 is cylindrical.
Fig. 6a to c various views of components of the mixing and dispensingsystem 10, withFig. 6a show a part schematic part sectional view. ansecond container 14 is connected to the interface in this example by a threadedconnection 58. Anend 62 of the second container disposed opposite an end 64 bearing thecap 34 comprises an outer thread engaging an inner thread at theinterface 16 forming the threadedconnection 58 of thesecond container interface 20 and its counterpart 20'.
In order to close of theend 62 following removal of thesecond container 14 from the interface apiston 60 is arranged at theend 62.
The other end of thesecond container 14 is sealed off via thecap 34 that is connected to the second container via a further threadedconnection 66.
Fig. 6b shows an enlarged view of circle B ofFig. 6a. Thecap 34 is connected to thesecond container 14 the threadedconnection 66.
Thecap 34 comprises a sealingplug 70 to seal with respect to thesecond container 14 and thecannula 30. The sealingplug 70 projects into thesecond container 14 from anend face 74 of thecap 34 in parallel toouter walls 76 of thecap 34.
Theouter walls 76 comprise an inner thread as part of the threadedconnection 66 that engages an outer thread on anouter wall 78 of thesecond container 14 in order to fix thecap 34 to the second container.
The sealingplug 70 comprises anouter sealing surface 72 that engages and provides a seal with respect to theinner sidewall 44. The sealing plug further comprises aninner sealing surface 70 that engages and provides a seal with respect to theouter surface 56 of thecannula 30.
As indicated the cap further comprises thevacuum port 26 via which air can be removed from thesecond container 14 on activation of the mixing and dispensingsystem 10. Thecap 34 comprises a hollow chamber 80 that is in engagement with an inner space 82 of thesecond container 14 via afilter 84. The filter prevents material of the two-component material M, M' being sucked out of the second container via thevacuum port 26.
Fig. 6c shows an enlarged view of circle A ofFig. 6a. The first andsecond containers 12, 14 are arranged at thesame side 86 of theinterface 16.
Theinterface 16 forms a platform 88 for the mixing and dispensingsystem 10. In this connection it should be noted that a surface 90 of theinterface 16 opposite to theside 86 of theinterface 16 at which the first andsecond containers 12, 14 are arranged is at least substantially flat or substantially flat. In this connection it means that the surface 90 is planar over at least 70 % of its extend with recesses potentially being present and projecting into theinterface 16 or projections projecting outwardly being arranged at the surface 90 (both not shown).
Thepiston 60 is initially arranged at theend 62 and provides a seal with respect to theinterface 16. For this purpose an outer surface 92 of thepiston 60 comprises a sealing lip 94 that engages theinner sidewall 44.
In order to introduce the material from thefirst container 12, theinterface 16 comprises aconnector 96. Theconnector 96 comprises a membrane that can be opened when thesecond container 14 is connected to the interface to allow the material M to arrive in the inner space of thesecond container 14 and automatically closes on removal of thesecond container 14 from theinterface 16, i.e. by removing thesecond container 14 via the threadedconnection 58.
In order to dispense the mixed material M, M' from thesecond container 14, as dispenser (not shown) can be coupled to theend 62 following removal of thesecond container 14 from theinterface 16. A plunger of the dispenser (both not shown) then comes into contact with thepiston 60 for dispensing said two-component material M', M" from saidsecond container 14.
The material can be dispensed from thesecond container 14 either via thecannula 30 or via a further outlet (not shown) connectable to thecap 34 via thesupport 32.
Fig. 7 shows a view of a second kind offirst container 12. Thefirst container 12 is configured to receive anampoule 100 for storage of the first material M.
Theampoule 100 is configured to store a liquid component M of the PMMA. On activation of the mixing and dispensingsystem 10, theampoule 100 is broken by rotating acontainer housing 102 relative to acontainer base 104 of thefirst container 12.
Thefirst container interface 18 and the counterpart 18' are formed by a threaded connection 106 , 20' at thefirst container 12 and thesecond container 14.
In order to seal thefirst container 12 relative to theinterface 16, aseal 108 is provided at aplug element 110 of thefirst container 12. Theplug element 110 is arranged at thecontainer base 104.
Anouter ring 112 of the container base comprises an inner thread forming the counterpart 18' and thefirst container interface 18 is formed by an outer thread of the threaded connection 106. An alternate arrangement could also be considered where thecontainer interface 18 is formed by an inner thread engaging an outer thread, e.g. present at theplug element 110.
In order to secure thefirst container 12 to thecontainer base 104, asecurity ring 114 may be provided that like a circlip ensures that thecontainer housing 102 is not moveable relative to thecontainer base 104 in the storage state of the mixing and dispensingsystem 10.
Areverse lock 116 is arranged at aninner surface 118 of thecontainer housing 102. Thereverse lock 116 cooperates with thecontainer base 104 in order to break theampoule 100 on activation of the mixing and dispensingsystem 10.
Figs. 8a to b show further views of thefirst container 12 ofFig. 7. Aseal 118 is arranged between thecontainer housing 102 and thecontainer base 104. On activation of the mixing and dispensingsystem 10, a vacuum is applied at thevacuum port 26 removing air from within the mixing and dispensingsystem 10.
Thisseal 118, e.g. an O-ring, ensures that the air can be removed from thefirst container 12 and that once theampoule 100 is broken the liquid M stored therein can be transferred via thepassage 22 to the second container where it is mixed with the second component M', e.g. powder if the two-component material is PMMA.
Following application of the vacuum, thesecurity ring 114 is removed and a user of the mixing and dispensingsystem 10 can then rotate thecontainer housing 102 further towards thecontainer base 104 via a threadedconnection 120 this causes a pressure to be exerted on theampoule 100, like in a vice or clamp which breaks theampoule 100 to release the component M therefrom.
Thereverse lock 116 is provided to ensure that thecontainer housing 102 can only be rotated in one direction of rotation only relative to thecontainer base 104, namely such that the two components are drawn to one another.
Fig. 8b shows a perspective view of thefirst container 12 storing anampoule 100. Also further kinds offirst containers 12 can be presented provided these can have a negative pressure, i.e. vacuum applied and ensure a breaking of theampoule 100 stored therein.
Fig. 9a to b show views of internal workings of thereverse lock 116 of thefirst container 12 ofFig. 7 and8.
The reverse lock comprises aratchet 122 formed by a non-uniform saw tooth arrangement and aratchet arm 124. The ratchet arm prevents rotation of thecontainer housing 102 in one direction of rotation due to blockingwalls 126 of the ratchet and can move in the other rotational direction due to theinclined walls 128 of theratchet 122 as indicated e.g. inFig. 9b.
List of reference numerals:- 10
- mixing and dispensing system
- 12
- first container
- 14
- second container
- 16
- interface
- 18
- first container interface at 16
- 18'
- counter part of 18 at 12
- 20
- second container interface at 16
- 20'
- counter part of 20 at 14
- 22
- passage
- 24
- mixer
- 26
- vacuum port
- 28
- handle
- 30
- cannula
- 32
- support
- 34
- cap
- 36
- mixing shaft
- 38
- hub
- 40
- hub connector
- 42
- end of 36
- 44
- inner sidewall of 14
- 46
- vane
- 48
- outer ring
- 50
- hub
- 52
- attachment mechanism
- 54
- projection
- 56
- outer surface of 30
- 58
- threaded connection
- 60
- piston
- 62
- end
- 64
- end
- 66
- threaded connection
- 68
- inner sealing surface
- 70
- sealing plug
- 72
- outer sealing surface
- 74
- end face of 34
- 76
- outer wall of 34
- 78
- outer wall of 14
- 80
- hollow chamber
- 82
- inner space of 14
- 84
- filter
- 86
- side
- 88
- platform
- 90
- surface
- 92
- outer surface of 60
- 94
- sealing lip
- 96
- connector
- 98
- membrane
- 100
- ampoule
- 102
- container housing
- 104
- container base
- 106
- threaded connection
- 108
- seal
- 110
- plug element
- 112
- outer ring
- 114
- security ring
- 116
- reverse lock
- 118
- seal
- 120
- threaded connection
- 122
- ratchet
- 124
- ratchet arm