HK1106995B - Device for producing a hardenable mass - Google Patents

Description

Device for producing a hardenable mass

Technical Field

The invention relates to a device for producing a hardenable mass, preferably a bone substitute and/or a bone reinforcing material or bone cement or the like, wherein a mixing container has a mixing space in which at least one powder and at least one liquid component are mixed to provide the hardenable mass. Piston means are arranged in the mixing space of the mixing container, said piston means being able to be held stationary relative to the mixing container and being released so that it can be moved relative to the container in a direction towards at least one opening through which the mixture can be discharged out of the mixing container, wherein at least one means able to rotate relative to the mixing container cooperates with the piston means for holding said piston means stationary relative to the mixing container in a rest position and releasing the piston means by rotating into a release position so that the piston means can be moved towards said opening.

Background

Osteoporosis is rapidly increasing, especially in industrialized countries. It is estimated that approximately 50% of all women suffer from fractures due to osteoporosis. These fractures occur mostly in the elderly and cause increased mortality, disability and enormous social costs. Vertebroplasty (verterbroplasy) is the percutaneous injection of bone cement into the spine in order to relieve pain in a compressive fracture caused by osteoporosis. Vertebroplasty was performed for the first time in france in 1984 and in the united states ten years later. Kyphoplasty (Kyphoplasty) refers to the expansion of a balloon in a collapsed spine to minimize the risk of further collapse of the spine and to provide a cavity filled with bone cement. Kyphoplasty is considered experimental in europe, but has recently been approved by the U.S. Food and Drug Administration (FDA) for use with polymer bone cements to treat pathological fractures. The drawback of kyphoplasty is that the procedure requires general anesthesia. However, vertebroplasty may be performed under fluoroscopy in an operating room, with concomitant administration of tranquilizers and analgesics. Both of these approaches produce satisfactory pain relief in greater than 75% of cases. Although providing satisfactory pain relief, early treatment of spinal compression with vertebroplasty is still controversial. It is recommended to wait at least six weeks before performing the vertebroplasty. While waiting, the analgesic treatment was tested. However, if there is a risk of complications from fixation or if the pain is severe, early treatment with vertebroplasty may be considered. In addition to pain relief, the primary goal of vertebroplasty is to prevent further spinal collapse. To identify fractures, MR can be used in addition to normal X-ray, which also shows edema in the bone marrow and fractures in the spine.

Vertebroplasty is performed on patients lying prone or on their side, which is controlled by a physician, during venous sedation and analgesia. During additional local anesthesia, a needle is inserted into a stylet (mandrine) in the spine via a transpedicular or posterolateral (posterolateral) access in a fluoroscopy. The needle should be located at the centerline, preferably at the anterior or anterior portion of the spine. Then, cement injection was performed. Another needle is usually required for symmetric filling of the spine. The cement injection needs to be carefully monitored by TV fluoroscopy and if a leak occurs outside the spinal limits, the injection is discontinued. The required dose of sufficient analgesic is small, approximately 2-3 ml. If larger doses are used, the risk of cement leakage during injection increases, as does the risk of bone marrow spreading into the circulatory system. Injection requires technical knowledge and training. Almost all major complications are associated with cement leaking out into the spinal canal or through the injection site. In more than 20% of cases, there is asymptomatic cement leakage into the paraspinal soft tissue or the lumbar veins.

Devices for the manufacture and discharge of substances for the above and similar uses have been disclosed in US4676655, GB2239818, WO2004/026377, WO99/65597, EP0657208 and WO 2004/002615. The prior art devices according to these publications are not simple devices allowing simple operations in connection with vertebroplasty and the like.

Disclosure of Invention

It is an object of the present invention to provide a simple device allowing simple operation in connection with vertebroplasty or the like. The object is achieved by providing the device of the invention.

The use of a device that allows a very simple operation is of great importance, especially in vertebroplasty, and it reduces the surgeon several technical measures to transfer cement from e.g. a mixing dish to a smaller syringe. Simple operations associated with mixing and discharging the cement are important. If polymethyl methacrylate is used, a closed system is required for hygienic reasons, so that the monomers are not released into the surrounding air. It is apparent that it is possible to have a prefilled system that allows for sterility and closed transfer to smaller syringes to improve control during injection. At present, we do not have a simple and effective mixing and discharge device that meets these requirements. The device must be able to handle the mixing of the polymer and ceramic material in well-balanced doses and to stop the injection in the event of a leak. In this respect, the present invention has several innovations.

According to one aspect of the present invention, there is provided an apparatus for manufacturing a hardenable mass, wherein a mixing container has a mixing space in which at least one powder and at least one liquid component are mixed to provide the hardenable mass, wherein a piston device is arranged in the mixing space of the mixing container, and wherein at least one device rotatable relative to the mixing container cooperates with the piston device for keeping the piston device stationary relative to the mixing container in a rest position, and by rotating to a release position, releasing the piston device so that the piston device is movable in one axial direction towards at least one first opening through which the mass can be expelled out of the mixing space, characterized in that the rotatable device is arranged to be movable in its release position with the piston device in the mixing space in said axial direction towards said first opening.

According to a further aspect of the invention, there is provided an apparatus for manufacturing a hardenable mass, wherein a mixing container has a mixing space in which at least one powder and at least one liquid component are mixed to provide the hardenable mass, wherein piston means are provided in the mixing space of the mixing container, wherein at least one means rotatable relative to the mixing container cooperates with the piston means to hold the piston means stationary relative to the mixing container in a rest position, and by rotating into a release position, the piston means is released such that the piston means is movable in one axial direction towards a first opening, and wherein a screw device is connectable with the mixing container, whereby the screw device is capable of transmitting a discharge movement to the piston means in one axial direction by a screw movement in order to discharge the mixed mass from the mixing space, characterized in that the screw device comprises a nut-type member which can be placed on the mixing container, whereby the screw device cannot rotate relative to the mixing container, the screw device further comprising a screw-type member which can be screwed into the nut-type member and which can be placed on an operating handle of the mixing device, whereby the operating handle and the screw-type member are connected non-rotatably relative to each other, and the screw-type member can move the piston means in one axial direction by screwing the screw-type member into the nut-type member by means of the operating handle.

According to another aspect of the invention, there is provided an apparatus for manufacturing a hardenable mass, wherein a mixing container has a mixing space in which at least one powder and at least one liquid component are mixed to provide the hardenable mass, wherein a piston device is arranged in the mixing space of the mixing container, wherein at least one device rotatable relative to the mixing container cooperates with the piston device to hold the piston device stationary relative to the mixing container in a rest position, and wherein the piston device is released by rotation into a release position such that the piston device is movable in one axial direction towards a first opening, characterized in that the mixing container can be connected to a dispensing device, and vice versa, that several containers can be connected to the dispensing device, and vice versa, that the mass mixed in the mixing space of the mixing container can be discharged to the dispensing device, the dispensing device is arranged for dispensing the substance into the spaces of the containers, whereby the respective space in each container is filled with a partial dose of the substance, and after removal of the container from the dispensing device, the partial dose of the substance can be sucked out and/or output out of the space of the container.

According to another aspect of the present invention there is provided a container for receiving and assisting in the discharge of a hardenable substance, the container being connected to a spigot provided at a front portion of the container, the container further being provided with a piston which is movable in an axial direction to assist the spigot in discharging a partial dose of the hardenable substance out of a space of the container, wherein a rear portion of the container has an opening which, when the piston is in the rear portion, is located in front of the piston, the opening allowing gas present in the space of the container to flow out of the space through the opening when the space is filled with the substance.

Drawings

The invention is further described below with reference to the accompanying drawings, in which,

FIG. 1 is a longitudinal section of the apparatus according to the invention during the mixing step;

FIG. 2 is an enlarged cross-sectional view of a portion of the apparatus of FIG. 1 showing a mixing device interconnected with a discharge device;

FIG. 3 is a cross-sectional view of the apparatus of FIG. 1 during a venting step;

FIG. 4 is a perspective view of a bracket forming part of the apparatus of FIG. 1;

FIG. 5 is a perspective view of a bleed piston forming part of the apparatus of FIG. 1;

FIG. 6 is a perspective view of a rotational movement prevention member forming part of the apparatus of FIG. 1;

FIG. 7 is a perspective view of a rotatable device forming part of the apparatus of FIG. 1;

FIG. 8 is a side view of a screw mechanism used in the apparatus of FIG. 1;

FIG. 9 illustrates a portion of the apparatus of FIG. 1 containing a powder component and during injection of a liquid composition;

FIG. 10 illustrates a portion of the apparatus of FIG. 1 connected to a dispenser apparatus;

FIG. 11 illustrates a perspective view of the dispenser apparatus of FIG. 10;

fig. 12 illustrates the device of fig. 1 when used in conjunction with vertebroplasty.

Detailed Description

The device 1 illustrated in the accompanying drawings is suitable for the manufacture of a hardenable mass 2, such as a bone substitute and/or a bone reinforcing material or bone cement or the like. The substance 2 is output and/or sucked out of the device 1, which contains a mixing container 3, for example, in the shape of a cylinder. The mixing container 3 defines a mixing space 4 in which at least one powder component 5 and at least one liquid component 6 are mixed to produce the hardenable mass 2.

In the mixing space 4 there is arranged a piston device 7 which is adapted to remain stationary relative to the mixing container 3 during the mixing step and subsequently to be released so that it can move relative to the mixing container 3 in the mixing space 4. For releasing the piston means 7, a rotatable means 8 is provided which in the rest position P1 holds the piston means 7 stationary relative to the mixing container 3 and which can be released relative to the mixing container 3 by rotating from the rest position P1 to a release position P2, whereby the piston means 7 can move in the mixing space 4. The piston means 7 and the rotatable means 8 are preferably directly or indirectly connected to each other.

The apparatus 1 preferably, but not necessarily, comprises a mixing device 9, the mixing device 9 being arranged for mixing the powder and liquid components 5, 6 with each other until the hardenable mass 2 is made. The substance 2 can then be stirred with the mixing device 9, if appropriate or desired. The mixing device 9 may comprise an elongated member 10, such as a hollow or solid rod, which extends into the mixing space 4 and has at an inner end located in the mixing space 4a mixing disc 11, said mixing disc 11 being provided with an axial hole 12 through said disc. The elongated member 10 is provided with an operating handle 13 for operating the mixing device 9 on the outer end outside the mixing space 4.

The mixing/stirring can be carried out in a known manner by moving the mixing device 9 back and forth in the mixing space 4 and preferably also rotating it relative to said mixing space 4.

The piston means 7 preferably has an axial bore 14 extending through it, the elongated member 10 of the mixing device 9 extending through the axial bore 14 into the mixing space 4. The elongate member 10 is engaged with the piston means 7 by one or more sealing rings 15 or the like, thereby forming a seal between the members. The elongate member 10 and the bore 14 of the piston means 7 are fitted to each other, whereby said elongate member 10 can move and rotate relative to the piston means 7.

At least one outer seal 16 or the like is arranged on the piston means 7 for cooperation with the inside of the mixing container 3, whereby a seal is formed between the piston means 7 and said inside. The outer sealing ring 16 is preferably designed such that it removes the substance 2 that accumulates on the inside of the mixing container 3 when it moves in the mixing space 4.

The piston means 7 may also have an opening 17 comprising at least one filter 18. The opening 17 is adapted to allow gas to escape from the mixing space 4 and the filter 18 is adapted to prevent the components 5 and/or 6 and the mixed substance 2 from being forced out of the mixing space 4 through the opening 17.

A rotational movement prevention member 19 is provided on the piston device 7. The member 19 is annular and comprises two axially arranged hook-shaped parts 20, 21 which can be inserted into grooves 22, 23 in the piston means 7 and hook over two shoulders 7a, 7b on the piston means 7 in the radial direction. By this positioning the rotational movement prevention member 19 is attached to the piston means 7 and cannot rotate relative to said means.

The rotational movement prevention member 19 further comprises an axially arranged flange 24 adapted to cooperate with the holder 25 for preventing rotation of the rotational movement prevention member 19, thereby preventing rotation of the piston means 7 relative to the holder 25, whereby the mixing means 9 is rotated relative to the piston means 7 for mixing the powder and liquid components 5, 6. The holder 25 has a cylindrical member 27 comprising an aperture 28, the rotatable member 8 being insertable into the aperture 28, the rotatable means being movable through the aperture 28 when disposed in the release position P2. The cylindrical member 27 of the holder 25 may have an annular snap portion 29 that can pass through one or more snap portions 30, the snap portions 30 being located inside the mixing container 3 and allowing the holder 25 to be attached to the mixing container 3 by snap fit. Alternatively or in combination with said snap part 29, the holder 25 may have several radially protruding members 33, 34 which can be attached by snap-in engagement with a radially outward flange 35 on the mixing container 3, so that the holder 25 cannot rotate relative to said container.

The rotatable means 8 has a through hole 8a through which the elongated member 10 of the mixing means 9 extends, whereby said elongated member 10 is movable relative to the rotatable means 8 and vice versa.

The rotatable means 8 has a first flange 36 or corresponding member extending radially outwards with respect to the direction U from the rotatable means 8 to a discharge opening 49 through which the substance 2 exits the mixing container 3. Said first flange 36 surrounds part of the circumference of the rotatable means 8.

The hole 28 of the bracket 25 has a second flange 31a or a corresponding second member directed radially into the hole 28 with respect to the direction U. The second flange 31a extends along part of the periphery of the hole 28. The part 31b or the corresponding third part of the hole 28 is free from said flange 31a and the part 31b or the third part is designed such that the first flange 36 of the rotatable means 8 can pass through it, thereby enabling the entire rotatable means 8 to pass through the hole 28 when the first flange 36 is mated with the part 31 b.

When the rotatable means 8 is set in the rest position P1 (fig. 1), the first flange 36 and the second flange 31a cooperate and prevent the rotatable means 8 from moving in the direction U relative to the holder 25, while the mixing means 9 is movable and performs a mixing movement for mixing the powder and the liquid component in the mixing space 4.

The rotatable means 8 can be set to its release position P2 (fig. 2) by rotating the rotatable means 8 by 180 ° with respect to the support 25 starting from its rest position P1, which rotational movement can be limited by the first flange 36 engaging or abutting the rotational stop 32. Thus, the first flange 36 of the rotating means 8 will be released from engagement with the second flange 31a of the holder 25, instead it can engage with the part 31b of the holder 25, so that the rotatable part 8 and thus the piston 7 can be moved and displaced in the direction U relative to the holder 25 and the mixing container 3.

The piston means 7 is prevented from rotating relative to the bracket 25 by means of the flange 24 of the rotational movement prevention member 19, the flange 24 of the rotational movement prevention member 19 preferably fitting or clamping into the part 31b of the bracket 25 when the rotatable means 8 holds the piston means 7 on the bracket 25.

The rotatable means 8 preferably cooperates with a connecting device 37, which connecting device 37 is arranged to connect the piston means 7 and the elongated member 10 of the mixing device 9, whereby by means of the mixing device 9 the piston means 7 (and the rotatable means 8 arranged there) can be moved in the axial direction U relative to the mixing container 3 in order to expel the mixed substance 2 from the mixing space 4. The connecting device 37 is located between the rotatable means 8 and the piston means 7 and is preferably designed to be operated by the rotatable means 8, whereby the connecting device 37 connects the piston means 7 with the elongated member 10 while the rotatable means 8 is rotated from its rest position P2 to its release position P2. To this end, the connecting device 37 may comprise connecting means 38, such as a washer, which is threaded on the elongated member 10 and located between the piston means 7 and the rotatable means 8. The piston means 7 has a support member 39 directed axially towards the rotatable means 8 and located on one side of the elongated member 10, while on the other side of the elongated member 10 there is a free space 40. The rotatable means 8 has an axially directed hole 41, the rear of which is provided with a helical spring 42 or similar elastic member and the front of which is provided with a pin 43 protruding from the hole 41.

When the rotatable means 8 is arranged in its rest position P1, the hole 41 with the helical spring 42 is located on the same side of the elongated member 10, whereby the helical spring presses the connecting means 38 against the support member 39, whereby said connecting means 38 is held in an intermediate position P3, in which the connecting means 38 abuts against the support member 39, allowing the elongated member 10 of the mixing device 9 to move in the opposite axial mixing direction B, so that the powder and liquid components 5, 6 can be mixed with the mixing device 9 in the mixing space 4, while the piston means 7 is held stationary relative to the mixing container 3.

When the rotatable means 8 is rotated 180 ° to its release position P2, the hole 41 and the helical spring 42 will also be rotated 180 ° relative to the support member 39, whereby the helical spring 42 presses or pushes the connecting means 38 into the space 40, in other words, the connecting means 38 is inclined relative to the elongated member 10 and is in the connecting position P4, in which the connecting means 38 is fixed to the elongated member 10. The piston means 7 is thus connected to the mixing means 9, so that the piston means 7 can be displaced in the direction U by said mixing means 9.

The connecting device 37 is preferably arranged such that after said mixing means 9 and the piston means 7 have been connected to each other, the connecting device 37 allows to release the mixing means 9 with respect to the piston means 7 if said mixing means 9 is pulled with respect to the piston means 7 in the return direction R.

On the operating handle 13 and/or on the elongated member 10, an outer member 45 may be provided having an open end 45a and thereby a cavity or recess 45b inside the end 45a, which end cooperates or abuts with the mixing container 3 when the mixing device 9 is moved in axial direction towards the mixing container 3 and rotated relative to said container during mixing. Thereby, said rotation of the mixing device 9 is prevented from being transmitted to the rotatable device 8.

A bracket 25 is preferably provided to prevent the piston means 7 and the mixing means 9 from being pulled away from the mixing container 3.

Since the rotatable means 8 can be moved together with the piston means 7 in the mixing space 4 of the mixing container 3, the device 1 is ensured to be simple, providing for a simple and quick handling when mixing of the powder and liquid components 5, 6 and discharging of the mixed substance 2 is carried out. For this purpose, it is only necessary to rotate the rotatable means 8 from its rest position P1 to the release position P2, and then the piston 7 can be moved in the direction U by the mixing means 9 in order to expel the substance 2 from the mixing space 4.

As an alternative to the opening 17, at least one opening 47 may be provided in the side wall of the mixing container 3, said opening 47 being adjacent to the piston means 7 when said piston means is held stationary by the holder 25. Since the opening 27 is located adjacent to the piston means 7, the opening 47 is closed when the piston means 7 starts to move in the direction U, after further movement of the piston 7 it will be located behind said piston means, in other words, only gas and no substance 2 can be pressed out through the opening 47.

As an alternative to said opening, at least one opening 48 may be provided in the side wall of the mixing container 3, halfway between the position in which the piston means 7 is held stationary by the holder 25 and a discharge opening 49 provided in the mixing container 3 for discharging the substance 2 from said container. The opening 48 may be closable, if desired.

The above-mentioned openings 17 or 47 or 48 allow to press the gas out of the mixing space 4, for example when injecting the liquid component 6 into said mixing space. The injection of the liquid component 6 is facilitated because gas can be pressed out therefrom. Due to the position of the opening 48 it allows to press or to discharge the gas entrained in the substance 2 out of the substance during the discharge thereof.

For various purposes, preferably in order to facilitate rapid aspiration of the liquid components and their dispersion in the powder component 5 and/or, for example, for sucking out toxic gases generated during mixing of the powder and liquid components 5, 6 therefrom, at least one vacuum generating device may be provided for forming a vacuum in the mixing space 4. In this case, there may be no opening for air to enter the mixing container 3, but the container must be sealed.

In order to create a vacuum in the mixing space 4, for example in order to suck out toxic gases, there may be a first vacuum-generating device 50 in a suitable position, which can be connected to the mixing container 3. The first vacuum generating device 50 is schematically illustrated in fig. 1.

For discharging, a linear force can be applied to the mixing device 9, whereby the mixing device 9 and the piston device 7 move linearly relative to the mixing container 3. Alternatively, the mixing device 9 may be moved linearly by the action of the screw device 51.

Said screw means 51 comprise, for example, a nut-shaped member 52 having a fork-shaped member 52a with an open side, said fork-shaped member 52a having an open side 53 which allows the nut-shaped member 52 to be fitted over the flange 35 of the mixing container 3 from the side whereby said member 52 is fixed to the mixing container 3.

The nut-shaped member 52 is provided with an internally threaded hole 54 for a screw-shaped member 55 having an external thread 56, the external thread 56 engaging with the thread in the internally threaded hole 54 of the nut-shaped member 52. The screw-type member 55 may be a tube having a polygonal nut 58, which may have a longitudinal groove 57 opening in a side direction, and which may have an opening side 60, whereby the screw-type member 55 and the nut 58 can be threaded on the elongated member 10 of the mixing device 9. Nut 58 is adapted to fit within a corresponding multi-faceted bore 59 in outer member 45 or any other member of operating handle 13 or on operating handle 13.

Thanks to the above described embodiment of the screw device 51, said device can be non-rotatably positioned on the mixing container 3, since the nut 58 can be inserted into the hole 59, the screw-type member 55 can be screwed into the nut-type member 52 by operating the handle 13 through, for example, the external member 45, so that the end 61 of the screw-type member 55 is in contact with the rotatable means 8 and can apply an expelling force in the direction U to the rotatable means 8 and, through said rotatable means, to the piston means 7.

The piston means 7 can be moved in the direction U by manually pushing or rotating the operating handle 13 and transmitting the rotary movement through the screw device 51. If a large force is required for expelling the substance 2 out of the mixing space 4, a gun-type discharge device 62, schematically indicated in fig. 1, or the like, may be used. The mixing container 3 is placed therein, whereby the pressure means 63 can cooperate with the mixing means 9 or, if no mixing means are present, directly with the piston means 7. The pressure means 63 are operated by means of a manually depressible trigger capable of moving the pressure means 63 in steps, whereby said pressure means, being forced, pushes the mixing means 9 and/or the piston means 7 forward in the direction U.

As can be appreciated from fig. 9, the mixing space 4 of the mixing container 3 may carry the powder component 5 when the device 1 is delivered. The discharge opening 49 is thereby closed by a closing device 64 which prevents the powder component 5 from falling out of the mixing space 4.

The liquid component 6 can be supplied to the liquid container 65 and can be fed into the mixing space 4 to be mixed therein with the powder component 5.

The liquid container 65 has a discharge end 66, and the closure device 64 may be designed such that the discharge end 66 is capable of opening the closure device 64 when the discharge end 66 is inserted into the device for injecting the liquid component 6 into the mixing space 4 and the powder component 5 therein. To this end, closure device 64 may include a normally closed valve body 64a, valve body 64a being opened by discharge end 66 when the discharge end is inserted into closure device 64, valve body 64a automatically returning to a closed position when discharge end 66 is removed or withdrawn from closure device 64.

A valve 67 can be arranged to cooperate with the closing means 64 to allow gas to be discharged from the mixing space 4 when the liquid component 6 is injected into said space from the liquid container 65. The valve 67 can be closed and can be opened when required.

In order to vibrate the contents of the mixing space 4, i.e. the powder and liquid components 5, 6 and/or the substance 2, the mixing container 3 or parts thereof may be brought into contact with a vibration device 68 which is schematically illustrated in fig. 9.

As can be appreciated from fig. 10, the mixing container 3 can be connected with a dispensing device 69 and vice versa. Several containers 70 can be connected thereto and vice versa, whereby the substance 2 mixed in the mixing space 4 can be output or discharged from said mixing space into the dispensing device 69. The dispensing device 69 dispenses the substance 2 into individual containers 70, thereby feeding multiple portions of the substance 2 into the interior space 71 in the containers 70. The inner space 71 in said respective container 70 is substantially smaller than the mixing space 4 of the mixing container 3, in other words the spaces 71 of a plurality of containers 70, for example the spaces 71 of 8 containers 70, can be filled with a portion of the dose 2a of the substance 2 from the mixing space 4.

When the space 71 of each of the plurality of containers 70 is filled with a partial dose 2a of said substance 2, each container 70 can be removed from the dispensing device 69 and vice versa, the partial dose 2a of substance 2 in the container 70 can be output and sucked out of the container 70.

The dispensing apparatus 69 preferably comprises a dispenser body 72 having an axial inlet tube 73, the axial inlet tube 73 being able to be brought close to an outlet or discharge end 74 of the mixing container 3 having the discharge opening 49. An inlet tube 73 can be positioned at the discharge end 74 by being threaded thereon or in other suitable manner, whereby the internal passage in the distributor body 72 communicates with the discharge port 49. Of course, the mixing vessel may alternatively be located on the inlet pipe 73.

The distributor device 69 may also comprise a number of discharge ducts 75-82, at least 2, for example 8, extending radially from the distributor body 72 in a star-shaped manner and communicating with the internal components of the distributor body 72.

Each container 70 has a front portion 84 by means of which front portion 84 each container 70 can be mounted, for example screwed, to one of the discharge tubes 75-82 of the dispensing device 69 and vice versa, thereby enabling a partial dose 2a of substance 2 to be fed into the space 71. During filling of the space 71, a piston 86 forming part of the reservoir 70 is preferably located in the rear portion 85 of the reservoir 70. After space 71 has been filled with a partial dose 2a of substance 2, a cannula or needle 83 may be positioned on front portion 84. A partial dose 2a of the substance 2 is delivered or sucked out of the space 71 of the container 70 through said cannula 83.

Each container 70 may have an opening 87 at the end, preferably formed in the rear portion 85, the opening 87 being immediately forward of the piston 86 when the piston is located in the rear portion 85. This opening 87 allows the gas in the space 71 of the container 70 to be pressed out of said space 71 when a partial dose 2a of said substance 2 is fed into said space 71. Thus, the gas in the space 71 is prevented from obstructing the partial dose 2a of substance 2 from entering said space 71. The opening 87 has a diameter of, for example, 0.2 to 1.0mm, preferably about 0.6 mm.

Alternatively, the opening 87 may be a slot (not shown) axially disposed in the interior side of the reservoir 70 that extends beyond the plunger when the plunger is located in the rear portion 85 of the reservoir 70.

When the required number of containers 70 has been filled with a partial dose 2a of substance 2, at which time one container 70 is removed from the dispensing device 69, a cannula or needle 83 is preferably mounted at the front 84 of the container 70, whereby a partial volume 2a of substance 2 can be output or sucked out through the cannula 83 with or without the aid of a piston 86 until the space 71 is emptied. By now removing the container 70 from the dispensing apparatus 69 and leaving the other filled container 70 mounted thereon, the substance 2 in the container 70 which has not been removed can be left unaffected for a sufficiently long time by the ambient air.

Since the size of the space 71 in each container 70 is known, it is possible to know exactly how large the partial volume 2a of the substance 2 is delivered or discharged from each container 70.

In order to treat the cancellous bone 89 with the material 2, the material 2 can be sucked into the interior 89a of the cancellous bone 89. For this reason, the vessel 70 can be connected to the cancellous bone 89 by inserting the cannula 83 or a member (not shown) connectable to the cannula 83 into the interior 89a, whereby the space 71 of the vessel 70 communicates therewith. The interior 89a of the spongy bone 89 is further connected via a connection line 92 to at least one vacuum source 90 for creating a vacuum in the interior 89a and in the space 71 of the container 70 connected thereto, whereby a partial volume 2a of the substance 2 is sucked out of the space 71 and into the interior 89a of the spongy bone 89 through the cannula 83. During the suction step, the piston 86 may eventually move in the direction U to assist the aspiration of the partial dose 2a of substance 2 out of the space 71.

The interior 89a of the cancellous bone 89 may be supplied with the substance 2 from the mixing container 3. The mixing container 3 can be provided with a cannula or needle (not shown) or the like, which is inserted into the interior 89 a. The substance 2 can thus be sucked out of the mixing space 4 of the mixing container 3 and into said interior 89a by means of the vacuum source 90. Finally, the suction of the substance 2 from the mixing space 4 can be assisted by moving the piston means 7 in the direction U.

Cancellous bone 89 may be, for example, an osteoporotic fracture of the spine or of the fracture type of the femur (femoral) or patella (patella).

The mixed substance 2 in the mixing container 3 can be used for graft fixation, whereby the container can be provided with a discharge tube or the like (not shown) through which the substance 2 is discharged by means of the piston means 7 into the bone cavity in which the graft is to be fixed.

The substance 2 may consist of a bone substitute and/or a bone reinforcing material, which is mainly composed of a calcium-based material or a ceramic that can be mixed with a hardening agent, such as water. These substances may be selected from the group comprising calcium sulphate-alpha-hemihydrate, calcium sulphate-beta-hemihydrate, calcium sulphate-dihydrate, calcium carbonate, alpha-tricalcium phosphate, hydroxyapatite, dicalcium phosphate-dihydrate, dicalcium phosphate anhydrous, tetracalcium phosphate, beta-tricalcium phosphate, calcium deficient hydroxyapatite, monocalcium phosphate-monohydrate, monocalcium phosphate, calcium pyrophosphate (calcium-pyrophosphate), precipitated hydroxyapatite, carbonaceous apatite (apatite carbonate), octacalcium phosphate, amorphous calcium phosphate, oxyapatite (oxyapatite), carbonate-containing apatite (carbonatoapatate) and calcium aluminate.

The ceramic material may be calcium aluminate, which forms part of the product Doxa T manufactured by Doxa corporation. (www.doxa.se/pdf/nyhet _1.pdf)

An X-ray contrast agent may be added to the ceramic bone substitute and/or bone reinforcing material, for example a water-soluble non-ionic X-ray contrast agent selected from the group comprising iohexol, ioversol, iopamidol, iotrolan, ioglucamide, iosyl alcohol, ioglucitol, ioglucamide, iogulamide, iomeprol, iopentol, iopromide, iosarcol, iosimide, iophtalamide, ioxathide, ioxaglic blue, iodolol and iodilol.

Alternatively, the substance 2 may be a hardenable bone cement comprising a polymer and a monomer component. The polymer may be Polymethylmethacrylate (PMMA) and monomeric Methyl Methacrylate (MMA). The polymer-based material may be Cortoss, a product of the Orthovita company of the United states^TM. See www.orthovita.com/products/cortiss/outstech. Another polymer-based material may be produced by parallelax mechanical incAcrylic ResinPMMA(www.parallax-medical.com/go/91-92b550-5642-1157-a432-d7a2b98310fe)。

The substance 2 may be a bone substitute and/or a bone reinforcing material and consists of minerals and/or ceramics combined with a polymer material.

The screw device 51 may be a device that can be connected to the mixing container 3, the mixing container 3 being designed in another way than illustrated in the figures, wherein the piston means 7 are positioned and operated in another way than illustrated in the figures.

The dispensing device 69 can be connected to the mixing container 3 and vice versa, the mixing container 3 being designed otherwise than as shown in the figures, wherein the piston means 7 are mounted in a manner other than as shown in the figures.

The invention is not limited to the embodiments described above and illustrated in the drawings. As an example not specified, it should be noted that the substance 2 may be another kind of substance than bone substitute and/or bone reinforcing material or bone cement or the like. The rotatable means 8 may cooperate with the piston means by other means than those illustrated and described; the mixing can be carried out in other ways than by using the mixing device 9, which can also be designed in other ways if such a device is present; the mixing vessel 3 can be designed in other ways than that described and illustrated; when a screw device 51 is used, it may be of another type than that described and illustrated, as well as for the dispensing device 69. The piston means 7 can be moved in the direction U by the mixing means 9 or sucked in the same direction by the vacuum source 90, but it is also possible to move the piston means 7 by using both the mixing means 9 and the vacuum source 90. The device 1 may be disposable or reusable.

Claims (57)

1. An apparatus for manufacturing a hardenable mass,

wherein a mixing container (3) has a mixing space (4), in which mixing space (4) at least one powder and at least one liquid component (5, 6) are mixed to provide the hardenable mass (2),

wherein a piston device (7) is arranged in the mixing space (4) of the mixing container (3) and

wherein at least one means (8) rotatable relative to the mixing vessel (3) cooperates with the piston means (7) for keeping said piston means (7) stationary relative to the mixing vessel (3) in a rest position (P1) and, by rotating to a release position (P2), releasing said piston means (7) so that it can move in one axial direction (U) towards at least one first opening (49) through which said substance (2) can be expelled out of the mixing space (4),

the rotatable means (8) is arranged such that the rotatable means (8) in its release position (P2) is movable with the piston means (7) in the mixing space (4) in the axial direction (U) towards the first opening (49).

2. The apparatus according to claim 1, wherein the rotatable means (8) comprises a first member (36), which first member (36) is engageable with a second and a third member (31a, 31b) arranged non-movable relative to the mixing container (3), whereby, when the rotatable means (8) is in its rest position (P1), the first member (36) of the rotatable means (8) is engaged with the second member (31a) of the mixing container (3) so as to prevent the rotatable means (8) and the piston means (7) from moving in the axial direction (U) towards the first opening (49),

by rotating the rotatable means (8) to its release position (P2), the first member (36) of the rotatable means (8) can be rotated out of engagement with the second member (31a) and into engagement with the third member (31b) so as to allow the rotatable means (8) and the piston means (7) to move in the axial direction (U) towards the first opening (49).

3. An apparatus according to claim 2, wherein the first member of the rotatable device (8) is a first flange (36) directed radially outwards from the rotatable device (8) with respect to said axial direction (U) and extending around a part of the circumference of the rotatable device (8), and the second member is a second flange (31a) directed radially into a hole (28) with respect to said axial direction (U) and extending along a part of the circumference of said hole (28), the rotatable device (8) being adapted to pass through said hole (28) when in its release position (P2), and

the third member is a part (31b) of the periphery of the aperture (28) which is free of the second flange (31a), the part (31b) being accessible by the first flange (36) of the rotatable device (8).

4. The apparatus according to claim 2 or 3, characterized in that the second and third members (31a, 31b) are arranged on a stand (25) that can be positioned on the mixing container (3).

5. The device according to claim 4, characterized in that the holder (25) can be attached to the mixing container (3) by snap-locking.

6. An apparatus according to claim 4, wherein a rotational movement preventing member (19) is provided to prevent rotation of the piston means (7) relative to the support (25) when the rotatable means (8) is rotated relative to the piston means (7).

7. An apparatus according to claim 6, wherein the rotational movement preventing member (19) is located on the piston means (7) and the rotational movement preventing member (19) is arranged to cooperate with the bracket (25) such that the bracket prevents rotation of the rotational movement preventing member (19), thereby preventing rotation of the piston means (7) relative to the bracket (25) when the rotatable means (8) rotates relative to the piston means (7).

8. Device according to claim 1, characterized in that a rotation stop (32) is provided for limiting the rotational movement of the rotatable means (8).

9. The apparatus according to claim 1, wherein the rotatable means (8) has a through hole (8a) for an elongated member (10) on a mixing device (9), said mixing device (9) being arranged for mixing the powder and liquid components (5, 6) in the mixing space (4).

10. An apparatus according to claim 9, characterized in that the rotatable means (8) cooperates with a connecting apparatus (37) arranged between the rotatable means (8) and the piston means (7) for interconnecting the piston means (7) and the elongated member (10) on the mixing means (9), and that

The piston means (7) is movable in an axial direction (U) by means of the mixing means (9) after being connected to an elongated member (10) of the mixing means (9) for discharging the mixed substance (2) from the mixing space (4).

11. Device according to claim 10, wherein the connecting device (37) comprises a connecting means (38) cooperating with a support member (39) on the piston means (7), said support member (39) being located on one side of the elongated member (10) of the mixing means (9),

the rotatable means (8) comprises an elastic member (42) located on the same side of the elongated member (10) when the rotatable means (8) is in its rest position (P1), whereby the elastic member (42) causes the connecting means (38) to be located in its intermediate position (P3) by abutting the connecting means (38) against the support member (39), and

the rotatable means (8), by rotating to its release position (P2), moves the resilient member (42) to an opposite side of the elongate member (10) and thereby locates the connecting means (38) in its connecting position (P4), in which connecting position (P4) the connecting means (38) is clamped or fixed to the elongate member (10).

12. Device according to claim 10 or 11, wherein the connecting device (37) is arranged to release the mixing means (9) from the piston means (7) when the mixing means (9) is pulled relative to the piston means (7) in a direction (R) opposite to said axial direction (U) towards the first opening (49).

13. The apparatus according to claim 9, wherein the elongated member (10) of the mixing device (9) comprises an external member (45) located outside the mixing container (3) and designed to come into contact therewith, preventing it from coming into contact with the rotatable means (8) in order to avoid said rotatable means (8) from rotating by means of the mixing device (9) when said mixing device (9) rotates during mixing of the powder and liquid components (5, 6).

14. An apparatus according to claim 1, characterized in that at least one second opening (17, 47, 48) is provided for releasing or discharging gas from the mixing space (4).

15. A device according to claim 14, characterised in that the second opening (17) is provided in the piston means (7).

16. The device according to claim 14, characterized in that the second opening (47) is located on the side of the mixing container (3) adjacent to the piston means (7) when the piston means (7) is held stationary by the holder (25), whereby the second opening (47) is closed by the piston means (7) when the piston means (7) is moved in one axial direction (U).

17. The device according to claim 14, characterized in that the second opening (17) has a filter (18) which prevents the powder (5) and/or the liquid component (6) and/or the substance (2) mixed from them from being discharged through the second opening (17).

18. Device according to claim 1, characterized in that at least one second opening (48) is provided at one side of the mixing container (3) at about half way between the piston means (7) and the first opening (49) when the piston means (7) is held stationary by the rotatable means (8), through which first opening (49) the mixed substance (2) can be discharged out of the mixing container (3), and that the second opening (48) is closable.

19. An apparatus as claimed in claim 1, characterized in that a vacuum generating device (50) is provided for generating a vacuum in the mixing space (4).

20. The apparatus according to claim 19, characterized in that the vacuum generating device (50) forms a vacuum in the mixing space (4) in order to accelerate the suction of the liquid component (6) into the mixing space (4).

21. Device according to claim 1, characterized in that a screw device (51) is provided for transmitting a discharge movement in one axial direction (U) to the piston device (7) by means of a screw movement in order to discharge the mixed substance (2) from the mixing space (4).

22. The device according to claim 21, characterized in that the screw device (51) comprises a nut-type member (52) which can be positioned on the mixing container (3), whereby the screw device (51) cannot be rotated relative to the mixing container (3),

the screw device (51) further comprises a screw-type member (55) which can be screwed into the nut-type member (52) and which can be located on an operating handle (13) of the mixing device (9), whereby the operating handle (13) and the screw-type member (55) are connected non-rotatably relative to one another and

the screw-type member (55) is capable of moving the piston means (7) in one axial direction (U) by screwing the screw-type member (55) into the nut-type member (52) by means of the operating handle (13).

23. Device according to claim 1, characterized in that the piston means (7) is designed as part of a screw for discharging the mixed substance (2) from the mixing space (4).

24. A device according to claim 1, characterized in that the piston means (7) is arranged to operate in one axial direction (U) for discharging the mixed substance (2) from the mixing space (4) by either,

(a) the piston device (7) is moved in an axial direction (U) by manually applying a linear discharge force to the operating handle (13),

(b) or by manually imparting to the operating handle a screw movement which can be transmitted to the piston device (7) by means of the screw device (51), so that the piston device (7) is moved in one axial direction (U),

(c) or by placing the device (1) in a gun-type discharge device (62) which can be operated stepwise to generate a discharge force which is transmitted to the piston means (7) to move it in the axial direction (U).

25. The apparatus according to claim 1, characterized in that the mixing space (4) of the mixing container (3) is sealed and comprises the powder component (5), and

at the beginning of the mixing of the powder and the liquid component (5, 6), the liquid component (6) can be fed into the mixing space (4).

26. The apparatus as claimed in claim 25, characterized in that the discharge opening (49) for discharging the mixed substance (2) from the mixing space (4) is closed by a closure device (64),

the liquid component (6) is located in a liquid container (65) having a discharge end (66), the liquid component (6) being able to be discharged or conveyed out of the liquid container (65) via the discharge end (66), and

the closure device (64) is arranged to be opened by the discharge end (66) of the liquid container (65) when the discharge end (66) is inserted into the closure device (64), whereby the liquid component (6) can be fed into the mixing space (4), and the closure device (64) is arranged to be closed again when the discharge end (66) of the liquid container (65) is removed or withdrawn from the closure device (64).

27. An apparatus according to claim 26, characterized in that a valve (67) is provided for cooperation with the closing means (64) for allowing gas to be discharged or to be circulated out of the mixing space (4) when feeding the liquid component (6) from the liquid container (65) into the mixing space (4).

28. The device according to claim 1, characterized in that the mixing container (3) is arranged to cooperate with a vibration device (68) for vibrating the powder and liquid components (5, 6) and/or the substance (2) in the mixing space (4).

29. Device according to claim 1, characterized in that the mixing container (3) can be connected to a dispensing device (69) and vice versa,

several containers (70) can be connected to the dispensing device (69) and vice versa,

the substance (2) mixed in the mixing space (4) of the mixing container (3) can be discharged to a dispensing device (69) arranged for dispensing the substance (2) into spaces (71) within the containers (70), whereby the respective space (71) in each container (70) is filled with a partial dose (2a) of the substance (2), and

after removal of the container (70) from the dispensing device (69), partial doses (2a) of the substance (2) can be sucked out and/or delivered out of the space (71) of the container (70).

30. The device according to claim 29, wherein the front portion (84) of each container (70) is connectable to a dispensing device (69) and vice versa, whereby a partial dose (2a) of the substance (2) can be fed into the space (71) of said container (70), and

after providing the space (71) of the container (70) with a partial dose (2a) of the substance (2), a cannula or needle (83) can be positioned at the front portion (84), and vice versa, the partial dose (2a) of the substance (2) can be sucked out or delivered out of the space (71) through the cannula (83).

31. The apparatus according to claim 30, wherein the piston (86) in each container (70) can be arranged in the rear part (85) of the container (70) when feeding a partial dose (2a) of the substance (2) into the space (71) of the container (70).

32. Device according to claim 29, wherein the rear portion (85) of the container (70) has a third opening (87), said third opening (87) being located in front of the piston (86) when said piston is located in said rear portion (85), said opening allowing the gas present in the space (71) of the container (70) to flow out of said space (71) through said third opening (87) when said space (71) is filled with a partial dose (2a) of the substance (2).

33. Device according to any of claims 29-32, characterized in that one container (70) can be removed from the dispensing device (69) at a suitable time for emptying it, while the other container (70) remains attached to the dispensing device (69).

34. The apparatus according to claim 1, wherein the mixing vessel (3) is capable of cooperating with an interior (89a) of cancellous bone (89), whereby the mixing space (4) of the mixing vessel communicates with said interior (89a), and

at least one vacuum source (90) is provided to create a vacuum in the interior (89a) of the cancellous bone (89), thereby drawing the mixed material (2) from the mixing space (4) into the interior (89 a).

35. An apparatus according to claim 34, characterized in that a piston device (7) is provided for discharging the substance (2) from the mixing space (4) while sucking out said substance (2) outside said space (4).

36. An apparatus according to claim 29, wherein the container (70) with the partial dose (2a) of the substance (2) is fittable with the interior (89a) of the spongy bone (89) in such a way that the space (71) in the container (70) communicates with the interior (89a) of the spongy bone (89), and wherein

At least one vacuum source (90) is provided for creating a vacuum in an interior (89a) of the cancellous bone (89) so as to draw a partial dose (2a) of the substance (2) from the space (71) into the interior (89 a).

37. A device according to claim 36, wherein a piston (86) is arranged to expel a partial dose (2a) of substance (2) from the space (71) while sucking the substance (2) out of the space (71).

38. The apparatus according to claim 34, wherein said cancellous bone (89) is cancellous vertebral bone.

39. The apparatus according to claim 34, wherein said cancellous bone (89) is an osteoporotic fractured femur or patella.

40. Device according to claim 1, characterized in that the piston means (7) are arranged to expel the mixed substance (2) for fixation of the bone graft.

41. The apparatus according to claim 1, characterized in that said substance (2) is a bone substitute and/or bone reinforcing material comprising a calcium-based material or a substantially calcium-based material or a ceramic or a substantially ceramic material component.

42. The apparatus according to claim 41, wherein said calcium-based or ceramic material is a hardenable mineral or ceramic capable of hardening in cancellous bone (89).

43. The apparatus of claim 42, wherein the calcium-based material or ceramic is hardenable by mixing with a hardening agent.

44. The apparatus of claim 42 or 43, wherein the calcium-based or ceramic material is selected from the group consisting of calcium sulphate-alpha-hemihydrate, calcium sulphate-beta-hemihydrate, calcium sulphate-dihydrate, calcium carbonate, alpha-tricalcium phosphate, hydroxyapatite, dicalcium phosphate-dihydrate, dicalcium phosphate anhydrous, tetracalcium phosphate, beta-tricalcium phosphate, monocalcium phosphate-monohydrate, monocalcium phosphate, calcium pyrophosphate, carbonaceous apatite, octacalcium phosphate, amorphous calcium phosphate, oxyapatite, carbonate-containing apatite and calcium aluminate.

45. The apparatus of claim 44, wherein the hydroxyapatite is calcium deficient hydroxyapatite.

46. The apparatus of claim 44, wherein the hydroxyapatite is precipitated hydroxyapatite.

47. The apparatus of claim 41, wherein an X-ray contrast agent is mixed in the ceramic material.

48. The apparatus of claim 47, wherein the X-ray contrast agent is water soluble and non-ionic.

49. The apparatus of claim 47, wherein the water-soluble non-ionic X-ray contrast agent is selected from the group consisting of iohexol, ioversol, iopamidol, iotrolan, ioglucamide, ioxitol, ioglucitol, ioglucamide, ioglunide, ioglumide, iomeprol, iopentol, iopromide, iosarcol, iosimide, iophtione, ioxil, ioxalone, and iodesimol.

50. The device according to claim 1, characterized in that the substance (2) is a bone cement comprising a polymer with a composition of polymethylmethacrylate and a monomer with a composition of methylmethacrylate, which compositions harden when mixed with each other.

51. The apparatus of claim 41, wherein the bone substitute and/or bone reinforcing material or bone cement is comprised of a mineral and/or ceramic combined with a polymeric material.

52. An apparatus for manufacturing a hardenable mass,

wherein a mixing container (3) has a mixing space (4), in which mixing space (4) at least one powder and at least one liquid component (5, 6) are mixed to provide the hardenable mass (2),

wherein a piston device (7) is arranged in the mixing space (4) of the mixing container (3),

wherein at least one means (8) rotatable relative to the mixing container (3) cooperates with the piston means (7) to hold said piston means (7) stationary relative to the mixing container (3) in a rest position (P1), and by rotating to a release position (P2), said piston means (7) is released so that it can move in one axial direction (U) towards the first opening (49), and

wherein the screw device (51) can be connected to the mixing container (3), whereby the screw device can transmit a discharge movement in one axial direction (U) to the piston means (7) by means of a screw movement in order to discharge the mixed substance (2) from the mixing space (4),

the screw device (51) comprising a nut-type member (52) which is positionable on the mixing vessel (3), whereby the screw device (51) is non-rotatable relative to the mixing vessel (3),

the screw device (51) further comprises a screw-type member (55) which can be screwed into the nut-type member (52) and which can be located on an operating handle (13) of the mixing device (9), whereby the operating handle (13) and the screw-type member (55) are connected non-rotatably relative to each other, and

the screw-type member (55) is capable of moving the piston means (7) in one axial direction (U) by screwing the screw-type member (55) into the nut-type member (52) by means of the operating handle (13).

53. An apparatus for manufacturing a hardenable mass,

wherein a mixing container (3) has a mixing space (4), in which mixing space (4) at least one powder and at least one liquid component (5, 6) are mixed to provide the hardenable mass (2),

wherein a piston device (7) is arranged in the mixing space (4) of the mixing container (3),

wherein at least one means (8) rotatable with respect to the mixing vessel (3) cooperates with the piston means (7) to hold said piston means (7) stationary with respect to the mixing vessel (3) in a rest position (P1), and to release said piston means (7) by rotation to a release position (P2) so that said piston means can move in one axial direction (U) towards the first opening (49), characterized in that,

the mixing container (3) being connectable to a dispensing device (69) and vice versa,

several containers (70) can be connected to the dispensing device (69) and vice versa,

the substance (2) mixed in the mixing space (4) of the mixing container (3) can be discharged to a dispensing device (69) arranged for dispensing the substance (2) into the spaces (71) of the containers (70), whereby the respective space (71) in each container (70) is filled with a partial dose (2a) of the substance (2), and

after removal of the container (70) from the dispensing device (69), partial doses (2a) of the substance (2) can be sucked out and/or output outside the space (71) of the container (70).

54. Device according to claim 53, characterized in that the front portion (84) of each container (70) can be connected to a dispensing device (69) and vice versa, whereby a partial dose (2a) of the substance (2) can be fed into the space (71) of said container (70), and

after providing the space (71) of the container (70) with the partial dose (2a) of the substance (2), a cannula or needle (83) can be positioned at the front portion (84), and vice versa, the partial dose (2a) of the substance (2) can be sucked out or output out of the space (71) through the cannula (83).

55. The apparatus according to claim 54, wherein a piston (86) in each container (70) can be arranged in the rear part (85) of the container (70) when a partial dose (2a) of the substance (2) is fed into the space (71) of the container (70).

56. A device according to any one of claims 53-55, wherein the rear portion (85) of the container (70) has a third opening (87), said opening (87) being located in front of the piston (86) when said piston is located in said rear portion (85), said opening allowing the gas present in the space (71) of the container (70) to flow out of said space (71) through said third opening (87) when said space (71) is filled with a partial dose (2a) of the substance (2).

57. An apparatus as claimed in claim 56, characterised in that one container (70) can be removed from the dispensing apparatus (69) at a suitable time for emptying it, while the other containers (70) remain attached to the dispensing apparatus (69).