Patent Application
20130048670
The present invention relates to a container comprising a hollow basic body in which a plunger is displaceably arranged. Hereinafter, such containers are referred to as “syringe-like” containers.
Syringes and syringe-like containers are known for a multitude of applications in medical and non-medical fields. For example, a normal one-way injection syringe comprises a hollow cylindrical syringe body made of plastic, in which syringe body a plunger is displaceably arranged. Normally the plunger is firmly connected to a plunger rod which extends in proximal direction from the syringe body. Normally, the proximal end of the plunger rod comprises an actuating flange, while normally the syringe body comprises two opposite holding flanges. The syringe is held between the index finger and the middle or ring finger. The thumb exerts pressure on the actuating flange in order to dispense a product located in the syringe through a distal outlet opening. The corresponding counter force is taken up by the holding flanges.
Furthermore, multiple syringes are known that comprise two or more interconnected syringe bodies that are arranged so as to be parallel or concentric, in which syringe bodies two or more identical or different components are accommodated, and from which syringe bodies the components can be dispensed by corresponding plungers being displaced. These components can, for example, be two different components of a pharmaceutical product, which components are to be intermixed only immediately prior to being administered, or two or more components of a bone cement or of a medical or non-medical adhesive, for example a fibrin-based medical adhesive. Many other applications of multiple syringes are known or imaginable. Such multiple syringes are frequently designed to be connected to a mixing device in order to intermix the components to be ejected immediately after they have left the multiple syringe. The plungers are frequently interconnected by way of a common actuating element.
Syringe-like containers are also used in the form of cartridges for special dispensers. In this case the external shape of the container frequently matches the use in a particular dispenser. A dispenser with a cartridge for two components is, for example, disclosed in WO 2008/009143.
In some applications it is desirable or mandatory for the product to be ejected to be stored for an extended period of time directly in a syringe-like container. The product can, for example, be a highly volatile, aggressive, hygroscopic or oxygen-sensitive substance. However, many commercially available plastics, for example the frequently used polyethylene, have a relatively high permeability to light molecules and thus provide an inadequate barrier to the diffusion of contents from the interior of the container to the exterior, or of extraneous substances such as water or volatile substances and gases from the exterior of the container towards the interior. Products stored in a container comprising such a plastic material can thus alter their characteristics in an undesirable manner when stored over an extended period of time.
While it is known per se to improve the diffusion resistance of plastics by suitable coatings, such coatings are usually not transparent. It is therefore not possible to visually check the contents of a coated container, for example in order to exclude the presence of air bubbles.
In order to store sensitive or aggressive products over extended periods of time in a diffusion-proof manner, it is known to hermetically seal such products in glass ampoules. However, it is very cumbersome to remove a product from such a container, because to this effect the ampoule needs to be broken or shattered.
It is also known to accommodate fluid products in so-called carpules made from glass. A carpule is a syringe-like container with a distal dispensing aperture and a proximal actuating opening. The distal dispensing aperture is closed off by a septum closure, i.e. by a penetratable cover, for example made from rubber, which normally is mechanically held on the container by means of a crimped aluminium rim. A displaceable plunger is inserted into the proximal end, which plunger closes off the container proximally. However, diffusion through the seals of the plunger and/or of the septum cannot reliably be excluded in carpules.
It is an object of the present invention to provide a syringe-like container that comprises reduced permeability to light molecules, thus providing improved diffusion resistance.
The above-mentioned object is met by a container with the features of claim 1.
The present invention furthermore relates to a dispenser with the features of claim 9 and to a method for manufacturing a container with a product contained therein, wherein the method comprises the features of claim 14.
Further embodiments are provided in the dependent claims.
A container is proposed that comprises a hollow basic body made from mineral glass, the container having a distal outlet opening and a proximal actuating opening, wherein the actuating opening is suitable and intended for inserting an actuating element into the interior of the basic body. In the basic body a plunger is arranged so as to be displaceable along a longitudinal direction in order to dispense from the container a flowable product that is present in the basic body between the plunger and the outlet opening. In order to improve the diffusion resistance of the container, the outlet opening is closed off by means of a first separable and/or removable seal, in particular a pull-off seal, that has been integrally sealed onto a first supporting surface surrounding the outlet opening, while the actuating opening is closed off by means of a second separable and/or removable seal, in particular a pull-off seal, that has been integrally sealed onto a second supporting surface surrounding the actuating opening.
In this manner a container is created which already because of the selection of materials of the basic body per se comprises very low permeability through the container wall. In addition, because of the seals, any diffusion in the region of the outlet opening or through the sealing gap between the plunger and the container wall is also prevented or at least significantly reduced. Consequently, such a container is suitable for longer-term storage of the product contained in the container. When the product is to be dispensed from the container, the seals can be separated or removed in a simple manner, e.g. by being penetrated or by being pulled off.
The product received in the container can be any flowable product, in particular a liquid, a suspension or emulsion, a gel, a paste or some other form of a flowable product with increased viscosity, a powder etc. The product is received in a product receiving region of the container, which product receiving region is preferably directly delimited by the basic body, the plunger and the first seal, i.e. there is no further shell between the product and the basic body, the plunger and the first (distal) seal. In other words the container is directly opened for dispensing a product in that the first seal is separated or removed. However, in particular a further seal, e.g. a septum closure, can be present which additionally seals off the distal outlet opening. Such an additional seal is then preferably arranged within that region of the container that is closed off by the first seal so that the first seal effectively reduces any diffusion which could take place through the additional closure alone.
The first seal and the second seal have been integrally and sealingly applied across the corresponding opening to a supporting surface on the basic body, e.g. adhesively bonded on or welded on (e.g. by laser welding, ultrasound welding or some other known methods). Preferably, the first and/or the second seal have/has been inductively sealed onto the corresponding supporting surface. To this effect the seal comprises at least one electrically-conductive layer and at least one thermoplastic adhesive layer. The seal is pressed onto the corresponding supporting surface and is subjected to an alternating electromagnetic field that induces eddy currents in the conductive layer. As a result of this the seal heats up and consequently the adhesive layer softens. This results in an adhesive connection between the supporting surface and the seal. In the inductive sealing process the use of a basic body comprising mineral glass is particularly advantageous because in contrast to metal-coated plastic containers no eddy currents arise in the basic body, and consequently the product contained in the container heats up only to a small extent.
The corresponding supporting surface preferably extends across, in particular perpendicularly to, the longitudinal direction. In order to increase the area of the supporting surface, the distal end and/or the proximal end can comprise/comprises a supporting flange that extends inwards or outwards across the longitudinal direction, which supporting flange increases the area of the supporting surface of the corresponding seal.
Each seal preferably consists of a relatively thin flat material, wherein the two seals can either consist of the same material or different materials. Preferably, the seals are thin, in particular relative to the surface area covered by the seal, with a thickness of less than 1/10 of the extension perpendicular to the thickness, and preferably thinner than 2 mm or even 1 mm. Preferably the seals are thinner than the sidewall region of the basic body in which the plunger is displaceable.
The seals can, for example, take the form of a single-layer or multi-layer film or foil, or can be formed by a laminate comprising several layers, wherein a layer facing away from the openings can, for example, comprise paper or cardboard. Preferably, each of the seals comprises a carrier, e.g. made of plastic, paper or cardboard, which carrier has at least one barrier layer. The barrier layer can, for example, consist of a diffusion-reducing polymer, e.g. poly(para-xylilene) (Parylene), that has been deposited on the surface of the carrier by a suitable method, e.g. by laminating or by physical or chemical vapour deposition (PVD or CVD). Preferably, however, the barrier layer comprises a metal or a metallic compound, or essentially consists of a metal or a metallic compound. The metal of the barrier layer can, in particular, be selected from the following metals and their alloys: aluminium, titanium, chromium, silver and copper. Aluminium is preferred. The thickness of the barrier layer is preferably approximately 20 nanometres to 20 micrometres. Each of the seals can also entirely consist of metal or of metal and an adhesive layer.
Each of the seals can comprise a weakened region, e.g. a perforation, in order to facilitate separation. As an alternative or in addition, each seal can comprise a tab for pulling the seal off. This tab can be designed so as to protrude from the basic body in order to facilitate gripping the tab.
The basic body is manufactured from a silicate-based mineral glass. Such glasses are frequently referred to as mineral glass in order to differentiate them from glass-like amorphous plastics such as PMMA. The basic body can be coated on the inside and/or on the outside, for example with a layer of lacquer or with a protective layer. Preferably, such a coating of the basic body is transparent in order to allow visual checking of the content of the container.
In some embodiments the basic body can comprise at least one holding flange that is arranged in the region of the actuating opening and that extends across the longitudinal direction, with said holding flange being used to hold in longitudinal direction the container during dispensing. In other words, the container can assume an actual syringe shape. If such a holding flange is present, it is preferred if at its proximal side it is aligned so as to be flush with that region of the basic body that delimits the actuating opening, and if the second seal has been applied to the flange, i.e. if the holding flange at the same time is also used as a proximal supporting flange for the second seal.
The container can receive a single product or several separate products. In particular, the container can comprise at least one second, hollow, basic body, connected to the first basic body, with an interior, with an exterior, with a distal second outlet opening, and with a proximal second actuating opening.
In this case in the interior of the second basic body a second plunger can be displaceably arranged in order to dispense a second product, present in the interior of the second basic body, from the container. In this case a removable or penetratable seal each has then also been sealed onto the second outlet opening and the second actuating opening. In particular, the first outlet opening and the second outlet opening can be jointly closed off by the first seal, and the first actuating opening and the second actuating opening can be jointly sealed off by the second seal.
The container according to the invention can be supplemented by an actuating element to form a dispenser. The actuating element is then designed to interact with the plunger in the interior of the basic body in order to dispense the product from the container. In order to facilitate opening the seal at the actuating opening, the actuating element can comprise at least one separating element that is designed to penetrate the second seal. The separating element can, for example, be a cutting element, a piercing element or a combination of such elements.
In particular, the actuating element can comprise a ram that extends along a longitudinal direction. This ram is then designed at its distal end to cooperate with a proximal rear of the plunger. The separating element can then comprise a blade, arranged in an outer rim region of the distal end, which blade is designed to cut the second seal in a region directly adjoining the basic body. This ensures a clean cut.
Preferably, a complete dispenser furthermore comprises a container holder that receives at least one container of the type stated above at least in part. The container holder then preferably comprises a piercing element for the first seal in order to cut the first seal during insertion of the container in the container holder or during movement in the container holder in the distal direction. In particular, this can be a hollow piercing element that forms a fluid duct in order to guide the product contained in the container to a dispensing aperture of the container holder. To this effect the piercing element can be shaped in the manner of a spike. At the container holder in the region of the dispensing aperture there is preferably a connection structure for connecting an accessory, e.g. a cannula, a mixer or a spray head.
A method according to the invention for manufacturing a container comprises the following steps:
Preferably, filling takes place through the outlet opening. As far as further optional details of this method are concerned, reference is made to the details provided above in the context of the device.
In the following, preferred embodiments of the invention are described with reference to the drawings, which are only provided for clarification and are not to be interpreted as being limiting. The following is shown in the drawings:
The container 100 comprises a hollow basic body 110 formed from a mineral glass based on silicate. The basic body comprises a cylindrical sidewall region to which in the region of the distal end of the container a taper 114 adjoins. At the distal end there is a radially-outward projecting first, distal supporting flange 115 that radially surrounds an outlet opening 111. At the proximal end there is an outward-projecting second, proximal supporting flange 112 which radially surrounds a proximal actuating opening 113. In the interior of the cylindrical sidewall region of the basic body 110 a plunger 120, which is displaceable along a longitudinal direction, with a circumferential seal 121 is arranged.
The distal outlet opening 111 is closed off by a first seal 150. To this effect the first supporting flange 115 forms a first supporting surface that extends perpendicularly to the longitudinal direction, onto which the seal 150 has been applied (sealed) in a materially bonded manner. The proximal end of the basic body 110 is also closed off by a second seal 160. To this effect the second supporting flange 112 forms a second supporting surface, which extends perpendicularly to the longitudinal direction, onto which second supporting surface the second seal 160 has been applied in a materially bonded manner.
Both the first seal 150 and the second seal 160 have been applied to the corresponding supporting flange by means of an inductive sealing process. To this effect each of the two seals 150, 160 comprises a multilayer design. A thermoplastic adhesive layer on the surface of the seal faces the corresponding supporting flange. This adhesive layer is followed by a metallic, electrically-conductive barrier layer. In addition, further layers can be present. These further layers can adjoin the metallic barrier layer towards the outside; however, they can also be present between the barrier layer and the adhesive layer. To seal the seal onto the corresponding supporting surface, the seal is pressed onto the supporting surface and is subjected to an alternating electromagnetic field. Consequently, eddy currents develop in the metallic barrier layer, which eddy currents heat up the metallic barrier layer and thus also the further layers of the seal. Because of this heating up, the thermoplastic adhesive layer softens, thus entering an intimate bond with the corresponding supporting surface. In this manner, after the alternating electromagnetic field has been switched off and the seal has been cooled, a liquid-proof and gas-proof connection between the basic body 110 and the corresponding seal 150, 160 is established. Such inductive sealing methods have per se long been known in the state of the art. The adhesive layer can also be formed on the corresponding supporting flange instead of on the seal.
In the application of such an inductive method it is presently particularly advantageous that the basic body 110 consists of a mineral glass. On the one hand mineral glasses are not electrically conductive, and on the other hand they are also relatively poor thermal conductors. Consequently, during inductive sealing only little heat transfer occurs between the corresponding seal 150, 160 and the basic body 110. This prevents the product contained in the container 100 from heating up excessively. If instead the basic body were made from a metallically-coated plastic material, the basic body 110 would also be heated by the alternating electromagnetic field, and consequently heating up the product contained in the container would not be avoidable in this case.
Two containers 100 of the type described above are inserted into the container holder 200. The container holder 200 comprises two parallel, cylindrical receiving regions 210 into which the two containers have been inserted from the proximal side. In a distal outlet region 213 of the container holder 200 in each case an insert 220 has been inserted, on which insert 220 a spike-like piercing element 221 has been formed that points in the proximal direction. The piercing element 221 is hollow; together with the remaining insert it delimits a fluid duct 222 which in each case flows into a dispenser aperture 215 (
As shown in
The actuating element forms a plunger rod 231 for each of the two plungers 120, which plunger rod 231 comprises at its distal end a feed flange 232 that cooperates with the corresponding plunger 120. At the proximal end the two plunger rods 231 are interconnected by means of a joint actuating flange.
In the position of
In order to eject the products from the containers 100, the user first displaces the two containers 100 in the distal direction in the container holder 200. If a latching element of the type mentioned above is present, the user exerts increased force for this or disengages the above-mentioned latching connection in some other manner. During the feed motion the piercing elements 221 pierce the corresponding first seal 150, thus establishing a fluid connection between the interior of the corresponding container and the corresponding dispenser aperture 215. When the containers have been slid-in completely, the proximal supporting flange 112 rests against a stop edge 212 of the container holder, which stop edge 212 has been formed by an annular recess in a holding flange 211 of the container holder.
Subsequently, the user removes the two second (proximal) seals 160 and pushes the actuating element 230 from the proximal end into the actuating openings 113 of the two containers 100 in order to advance the two plungers 120 of the containers 100 and in this manner eject the corresponding products contained in the containers 100 through the corresponding outlet opening 111. During this process the corresponding product moves through the corresponding fluid duct 222 to the corresponding dispenser aperture 215. The situation at the end of this dispensing process is shown in
The distal end of the container holder 200 comprises a connection structure for an accessory 300, in the present case a static mixer. The accessory receives the ejected products from the dispenser aperture 215, mixes them together and delivers the mixture at its own distal end. In the embodiment shown, the connection between the accessory 300 and the container holder 200 is established by way of a bayonet-like device. Such an accessory and its connection with a dispenser device is, in particular, described in detail in document US 2001/0004082, to which express reference is made with respect to the connection of the accessory with the dispenser. The connection between the accessory and the container holder can, however, also be made in some other known manner, for example as a plug-type connection by way of Luer cones.
A second embodiment of the present invention is shown in
In contrast to the first exemplary embodiment, in the present exemplary embodiment the user need not remove the second seal 160 prior to inserting the actuating element 230 into the actuating opening 113; instead the actuating element 230 pierces the second seal 160 during insertion. To this effect the distal end of the actuating element 230 in the region of the feed flange 232 comprises a circumferential circular cutting edge 234 that cuts the seal 160 in a region directly adjacent to the cylindrical sidewall of the basic body 110. Correspondingly, the proximal end of the plunger 120 comprises an annular indentation to receive the cutting edge 234. In this embodiment the first seal 150 can be penetrated by an accessory, or it can be manually removed prior to the content of the container 100 being dispensed.
Of course, a multitude of modifications are possible without leaving the scope of the invention. In particular, container shapes other than those shown in this document are also possible. The seals 150 and 160 can also have been applied in some manner other than by inductive sealing-on, for example by adhesive bonding or ultrasound welding. Depending on the method of applying the seals, the seals will be of a correspondingly different design, wherein a multilayer structure is preferred. If a container holder is used, it can, of course, also be designed in a manner that differs from that of the above-described first exemplary embodiment, and can, in particular, also comprise other devices for attaching an accessory. Of course, it is also imaginable for such a container holder to receive only a single container, or more than two containers, and for the actuating element to be designed accordingly to advance only a single plunger, or more than two plungers simultaneously. A multitude of other modifications are possible.
| Number | Date | Country | Kind |
|---|---|---|---|
| 764/10 | May 2010 | CH | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/CH2011/000085 | 4/18/2011 | WO | 00 | 11/5/2012 |
