Fluid prefillable or prefilled container and cannula assembly and closure system for a fluid prefillable or prefilled container - Patents.com

Abstract

To provide a container which can be prefilled or is prefilled with fluid, as well as a cannula assembly and closure system for a container which can be prefilled or is prefilled with fluid.SOLUTION: A container 1 includes: a syringe, cartridge, or injection device provided with a chamber 13 for containing fluid, particularly with a syringe body; and a cannula assembly. The cannula assembly includes a cannula 40 and a sealing member 30. The cannula assembly can be attached to a receptacle 10 which has a closure cap 70. An external passage opening of the cannula projects into a sealing of the closure cap that seals a passage opening 43, preferably into an elastomer internal region 72. The chamber is fluid tightly sealed on the basis of a radial and / or axial compression and passage opening sealing of the sealing member by the closure cap.SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] The present invention relates to a container that can be or is pre-filled with a fluid, particularly a pharmaceutical or cosmetic sample, a cannula assembly and closure system for a container that can be or is pre-filled with a fluid, particularly a pharmaceutical or cosmetic sample, where the container may include a syringe or cartridge, a syringe body or an injection device.

[0002] Fluids, particularly pharmaceutical or cosmetic products, can be stored in the container and / or injected or administered through the container. In the case of pre-filled syringes, the application generally focuses on injection, but in the subject matter of the present invention, the fluid can be removed. Such systems can be used, for example, for dispensing for injection. Furthermore, the application can include, but does not include, the penetration of the human or animal body, and can include, for example, the administration of drops of anesthetic to the patient's body area, which is often the case in practice, for example, for local anesthesia in oral surgery, before anesthetic injection.

[0003] Within the scope of the present invention, the reference to "medical samples" also includes veterinary medical samples and their appropriate uses.

[0004] The proper storage and correct use of these samples in general, and sterility during the entire storage period in particular, are of paramount importance.

[0005] Containers for cosmetic or pharmaceutical samples, such as syringes or cartridges as described within the present disclosure, also contribute significantly to the administration of these samples. These generally cylindrical containers typically have a chamber for receiving the sample, the chamber being defined by a proximal end and a distal end.

[0006] Within the framework of this disclosure, the proximal end always means the end into which a stopper or plunger is inserted, whereas the distal end means the end into which, for example, a cannula with its cannula assembly can be attached. General descriptions in the relevant specialist literature describe the proximal end as the end that faces the user during normal handling, and the distal end as the end that faces away from the user towards the patient during administration of the cosmetic and / or medical sample.

[0007] Wherever these terms "proximal" and "distal" are used with respect to various assemblies, it is intended that the above-mentioned geometric conditions are disclosed herein as well for each assembly.

[0008] Thus, during a typical administration of a pharmaceutical or cosmetic product, the proximal end will face towards the user and the distal end will face away from the user.

[0009] A plunger may be inserted, in particular at the proximal end, in order to move the sample, in particular in a lateral movement, in the distal direction through a through-passage provided at the distal end of the container, or in the opposite direction to draw the sample or the patient's body fluid through said opening into the container, in particular a syringe. The end member of the container surrounding the through-passage is often designed, at least in cross section, with a conically tapered tip or cone.

[0010] To inject or administer a sample, this cone may be fitted with a cannula, for example as described in publication GB 377891. The arrangement described there for the cone allows for a simple exchange of the cannula. A similar connection principle between a cannula, a cone and a syringe is described in US 2034294.

[0011] Another embodiment for the connection of the cannula to the syringe is described in the publication WO 02087671. In order to prevent the risks inherent in a cannula that is permanently attached to the syringe, such as the transmission of diseases through contact with a used cannula, a system has been proposed in which the cannula can be retracted into the chamber of the container after administration of the sample, in this case by retracting the plunger, which retracts the entire cannula into the chamber.

[0012] In order to administer drug samples more quickly and easily, currently, syringes or cartridges that are already pre-filled are increasingly used.This avoids the need to transfer active substance from a first reservoir into the chamber of a container before administration, which on the one hand shortens the time required for administration and on the other hand helps to avoid loss due to sample transfer.This is particularly advantageous in the case of advanced drug therapy.In addition, it can also reduce the risk of contamination and infection of active substance.

[0013] For this purpose, plastic containers with closures are known in the medical field, as described, for example, in the publication DE 10 2014 007 604 A1. The pre-filled containers can be sealed by a closure, which can be removed when administering the sample and replaced by a cannula.

[0014] Further containers are described, for example, in DE 102014211018 A1. The containers described in this publication are made of glass in order to take advantage of the inert properties of glass with respect to expensive and highly effective drug therapies. The opening of the glass container is sealed by a plastic connecting element which seals the chamber of the container and the outlet of the sample in the container. To administer the sample filled in the container later, the connecting element is removed and the container is now connected to a cannula, after which the sample can be administered via the cannula.

[0015] Although pre-filled syringes can be produced in this way, administering the sample still requires a certain effort, since the chamber of the container must be opened before each administration. Furthermore, a suitable cannula must be found, opened and connected to the pre-filled syringe. In addition to increasing the time required, this modification also involves a certain risk of contamination, for example if the opened cannula comes into contact with an undesirable substance before it is attached to the syringe.

[0016] Furthermore, disposable syringes with a ready-to-use filled drug are known, for example the pre-filled disposable syringe described in the publication DE 27 17 830 A1, which already has a cannula attached.

[0017] The publication EP 1 364 670 Search Report also describes a disposable syringe with a cannula in the needle passage of the syringe.

[0018] In this type of disposable syringe, the cannula is first connected to the container body. The syringe is then filled with the drug sample. In the case of plastic containers, the cannula is often already attached to the container during the manufacture of the container, which is typically done during the injection molding process, i.e. the cannula is covered with the injection molding material that is injected and is then connected to the container so as to be sealed with the material. However, this is inconvenient because it is necessary to provide an injection molding tool that is suitable for each geometric shape of the cannula or container.

[0019] This also means that the container body must be moved along with the cannula during the manufacturing process, which requires special care in handling each container body and cannula.

[0020] An additional significant drawback is that cannulas with a relatively small diameter cannot be properly connected to the container body during the injection molding process. The common size identification means of cannulas with respect to the outer diameter is the size designated by the gauge (G). Cannulas with an outer diameter larger than 30G, i.e. 31G, 32G, 33G or 34G, cannot be routinely manufactured in the injection molding process. Thus, pre-filled disposable syringes with ready-to-use filled medicaments are not provided with such thin cannulas, especially with sizes of 31G to 34G. This is disadvantageous insofar as cannulas with as small an outer diameter as possible are used, for example when injecting a medicament sample into the human body, since a smaller outer diameter of the cannula reduces pain sensation.

[0021] Furthermore, the resulting variation in sample chamber size associated with different dimensions of cannulas, for example, can rapidly increase, leading to a large number of tools required for manufacture and costly storage.

[0022] The cannula is often glued into the passage of the syringe. This is generally considered to be disadvantageous, since additive materials are used here which may lead to undesirable contamination of the prefilled sample, especially over a relatively long period, for example over one to three years. In this case, contamination of the drug sample, which may occur due to outgassing of or from the adhesive used, may also be disadvantageous. This may result in, for example, contamination and damage to the prefilled drug. Since such contamination may not be visible to the user, it is desirable to avoid this with a particularly high degree of certainty.

[0023] It is therefore desirable to provide a pre-fillable container for pharmaceutical samples that can be filled with a fluid, in particular a pharmaceutical or cosmetic sample, and that allows administration or injection of said fluid from or with the pre-filled container without the need for removal of a closure and / or attachment of a cannula or other component.

[0024] It is preferred here that the fluid pre-filled container provides an improved storage capacity, preferably of at least 1 year, preferably of at least 2 years, particularly preferably of at least 3 years or more. The fluid pre-filled container should meet the current sterility requirements of the pharmaceutical sector, especially those relating to storage of pharmaceutical samples, over said period, especially if the fluid is a pharmaceutical or cosmetic sample.

[0025] Wherever possible, it is desirable here to rely on the existing geometries of currently available containers, in particular syringes, syringe bodies, cartridges or injection devices and cannulas.

[0026] In summary, it is an object of the present invention to provide a container for storing and administering fluids, in particular pharmaceutical or cosmetic products, which can be stored for long periods of time, which is flexible in terms of the dimensions of the reservoir and cannula, and which is pre-assembled or pre-assembleable and pre-filled or pre-fillable.

[0027] In this case, the prefillable or prefilled container is advantageously equipped with a very thin cannula, in particular a cannula having a gauge size of 31G to 34G.

[0028] Additionally, it is desirable for the pre-filled containers to have a shelf life of at least three years, where current sterility requirements for storage of fluids, particularly pharmaceutical or cosmetic samples, are adhered to.

[0029] Additionally, commercially available modular containers and cannulas may be advantageously used.

[0030] Said object is achieved by the features of claim 1, which in particular provide the advantageous effects mentioned above.

[0031] The prefillable or prefilled container for storing and / or administering a fluid, in particular a pharmaceutical or cosmetic product, provided by the present invention comprises: a container with a chamber for containing a fluid, in particular a syringe, cannula or injection device with a syringe body, The device further includes a cannula assembly mountable to the container, the cannula assembly including a cannula and a seal member; Further, the device has a closure cap, the external passage opening of the cannula projects into the seal, preferably into the elastomeric interior region of the closure cap, thereby sealing the passage opening; Due to the radial and / or axial compression of the sealing member and the sealing of the passage opening by the closure cap, the chamber is sealed fluid-tight.

[0032] An advantageously facilitated storage period with respect to stability and sterility of more than three years is achieved by axial and / or radial compression of the sealing member of the cannula assembly and sealing of the cannula, particularly by the closure cap, where at least two sealing areas are defined, namely, a sealing surface of the sealing member facing towards the forward area or distal end of the container, preferably in the Luer lock embodiment, and a seal within the closure cap of the cannula, sealing the external passage opening of the cannula.

[0033] This advantageously results in the use of pre-filled containers as disclosed herein for the sterile storage of pharmaceutical or cosmetic samples over a storage period of one year or more, preferably two years or more, and particularly preferably three years or more.

[0034] The term "pre-filled container" here denotes a filled container which does not necessarily have to be filled by the respective user, but has already been filled, for example, by the respective sample manufacturer or - for example with additional filling substances or active substances - by the respective processor or filler in subsequent processing.

[0035] However, the containers disclosed herein can also be pre-filled by the secondary user himself, for example in a clinical environment, in order to store the containers for particularly long periods of time and to be ready for immediate use in time-critical situations, such as may occur, for example, in emergency medicine, whereby samples for use in time-critical or emergency medicine situations can be stored for longer periods and regular replacement of samples based on the expiration date of a particular sample can be significantly reduced.

[0036] Sterile storage, as used herein, refers to storage that meets the required sterile conditions for a specified period of time. Such sterile conditions typically require that the pre-filled containers disclosed herein be stored within 10 minutes of sterilization. -6 The point is that the number of living organisms, e.g. bacteria or microorganisms, is less than 1 / 10 ...

[0037] The cannula assembly and adapter are used to firmly and permanently connect a cannula to a container such as a syringe, syringe body, cartridge or injection device, thereby sealing the opening at the distal end, thereby providing a prefillable container for storing and administering a fluid, particularly a pharmaceutical or cosmetic product. A prefillable or pre-filled container according to the invention thus comprises at least one container as described above and a cannula attached to the container.

[0038] To contain a fluid, the container may have a chamber that is filled or fillable with the fluid. The fluid may include a pharmaceutical or cosmetic product. The pharmaceutical or cosmetic product may include a liquid, gas, solid, or mixtures thereof. The container pre-filled with fluid may be stored for an extended period of time before the fluid is administered through the cannula.

[0039] It would be advantageous if removal of the closure and / or attachment means of the cannula or another component prior to administration would not be necessary. The invention makes it possible to fill a reservoir with fluid and - before or after - firmly and permanently bond the cannula to said reservoir, thereby sealing the opening at the distal end. Pre-filled containers can be stored for extended periods and then made "ready to use" for administering fluids, such as pharmaceutical or cosmetic samples.

[0040] The manufacturing process is relatively simple since there is no need to attach a cannula during fabrication of the reservoir.

[0041] The present invention allows the use of commercially available containers, in particular syringes, syringe bodies, cartridges or injection devices and cannulas, which facilitates their availability insofar as they can be combined with one another in multiple ways, thereby allowing a wide range of containers and cannulas for pre-fillable or pre-filled containers to be presented in modular form.

[0042] This further advantageously allows the number of devices and tools, for example the number of injection tools, to be significantly reduced.

[0043] That is, commercially available components can be combined into a pre-manufactured unit as desired. The present invention thus offers the great advantage of cost savings, especially with regard to equipment and tools, while at the same time offering a high degree of versatility in formats and cannulas.

[0044] Furthermore, additional components, such as adhesives, can be omitted in the contact area with the fluid, which leads to improved storage capacity, since undesired contamination of the fluid with reaction products of the components or adhesives can be avoided.The risk of contamination of the fluid due to outgassing from the adhesive can also be avoided, which is particularly important in the case of pharmaceutical or cosmetic products.

[0045] One great advantage of the invention is that the connection between the cannula and the container can be designed to be particularly fluid- and gas-tight. The tightness of the connection can be verified, for example, via a helium overpressure test according to DIN EN 1779. In this case, the chamber of the container can be supplied with helium or a gas mixture containing helium and the chamber can be closed and pressurized. Leaks can then be detected outside the container with the aid of a suitable leak detector. A liquid-tight and gas-tight connection between the cannula and the container can be verified and verified by such a test.

[0046] The present invention allows to create a tight joint between the cannula and the container during pressurization up to 2 bar, preferably 3 bar or more. The joint between the cannula and the container can thus be classified as microbiologically tightly sealed. The design of the joint between the cannula and the container therefore forms a sterile barrier allowing long-term storage capability.

[0047] This results in a major advantage of the present invention, in that a container pre-filled with a fluid, e.g. a pharmaceutical or cosmetic product, can be stored after filling and sterilization for at least 1 year, preferably at least 2 years, particularly preferably at least 3 years or more, without the stability and sterility of the fluid, e.g. a pharmaceutical or cosmetic product, being unacceptably compromised.

[0048] The manufacture of a pre-filled container according to the invention, including the reservoir and cannula, may be carried out as follows: the required components are manufactured, assembled under clean room conditions, then sterilized and aseptically packaged. The pre-fillable container is then aseptically filled with a fluid, such as a pharmaceutical or cosmetic product, resulting in a pre-filled container according to the invention.

[0049] It is also possible to fill pre-fillable containers with fluids, especially pharmaceutical fluids, in a clean room and then sterilize the pre-filled containers according to the present invention.

[0050] For the administration of pharmaceutical or cosmetic products, containers such as syringes, syringe bodies, cartridges or injection devices suitable for the present invention are known and are available in various sizes in the medical field. Such containers are generally cylindrical in shape and have a central chamber for containing a fluid. The chamber is axially defined by a proximal end and a distal end. The distal end refers to the end of the chamber facing away from the hand of the person operating the device when administering the fluid.

[0051] The proximal end of the chamber typically has an opening into which a stopper can be inserted and moved, for example hydraulically via a piston rod or by using a pump, to move the filled fluid toward the opposite axially distal end, which typically includes a tip with a through passage leading to the chamber. The key element here is the insertion of the stopper. The stopper is then moved by the piston rod or, for example, hydraulically, toward the cannula, for example to deliver the drug. The tip may be stepped, reduced in diameter, or conically tapered.

[0052] In this case, by movement of the associated stopper, fluid may be withdrawn through said through passage, typically within the stepped tip.The central axis of the container forms the longitudinal axis of the device described below.

[0053] When referring now to administration, it should be understood that this is on the one hand the injection of a fluid, such as a pharmaceutical or cosmetic product, using a pre-filled or filled container, and thus administration includes, for example, the injection of a cosmetic or pharmaceutical product from a pre-filled container into the human body.

[0054] However, it is also possible for a pre-fillable container according to the invention to be used for withdrawing or receiving fluids, in which case the term administration applies to the receiving of fluids into the chamber.

[0055] Administration also includes use of the container for dispensing, for example in connection with injection, whereby during administration, fluid flows through the passageway into the chamber or flows through the passageway out of the chamber.

[0056] In the present invention, a cannula assembly and an adapter are provided for coupling the cannula to the container.

[0057] Thus, in one further aspect of the present invention, the subject cannula assembly comprises: a cylindrically symmetrical seal member having an axial passage and a cannula; the cannula is disposed coaxially with respect to the seal member and at least partially within the central passage of the seal member; a portion of the outer surface area of ​​the cannula is firmly connected to the sealing member in a material-tight and / or form-fitting manner; and At least one end face of the seal member includes an annular region surrounding the passageway and defining an end seal surface in a plane perpendicular to the central axis of the seal member.

[0058] When referring to material-sealing and / or form-fitting bonds within the scope of the present invention, the term "material-sealing" refers to the bonding of binding partner members by atomic or molecular forces. The term "form-fitting" refers to the locking of at least two binding partners together.

[0059] The cylindrically symmetrical seal is designed with a central axial passage, which is used to accommodate a cannula.

[0060] In the following, a cannula preferably means a hollow needle or an injection needle with a through passage that can be used in the medical field.

[0061] The outer diameter of the cannula is typically indicated with a gauge size designation and is registered in the relevant standards EN ISO 6009 and EN ISO 9626. In the present invention, cannulas having outer diameters of 10G to 34G or even smaller can be used. Common gauge sizes that can be assembled by gluing or by injection molding are 10G to 29G.

[0062] A cannula with a smaller outer diameter is more advantageous for patient-friendly administration of pharmaceutical samples. Thus, the present invention allows the use of cannula sizes of 27G to 30G, preferably 31G and 32G, and particularly preferably 33G, 34G and larger.

[0063] In the present invention, the cannula may be coaxially arranged relative to the seal member such that in the assembled position the cannula is at least partially disposed within the central passage of the seal member, whereby the seal member and the cannula are preferably firmly and intimately connected to each other. The connection between the cannula and the seal member is preferably designed to be impermeable to liquids and / or gases.

[0064] The cannula assembly may be attached to the distal end of the vessel to position the cannula radially and / or axially relative to the vessel through passageway.

[0065] Furthermore, the cannula assembly, in its installed position, can ensure the necessary sealing of the passage through the container. In order to fix the cannula assembly to the distal end of the container and to produce a sealing effect, the sealing member is subjected to axial contact pressure in its installed position and is pressed toward the distal end. For this purpose, an adapter is provided in the present invention.

[0066] The liquid-tight and / or gas-tight sealing of the through passage of the container is produced, on the one hand, by the already described liquid-tight and / or gas-tight design of the connection between the sealing element and the cannula, which prevents the passage of fluids or other substances between the sealing element and the cannula, and, on the other hand, by the pressing of the end face side of the sealing element against the tip surrounding the through passage.

[0067] In this way, the sterility requirements of the pharmaceutical or cosmetic sample can be met when the pharmaceutical or cosmetic sample is filled into the chamber, since the ingress of foreign substances such as gases, bacteria or other substances into the chamber can be prevented.

[0068] The cannula may be held in the passage of the sealing member, for example by clamping and / or friction, i.e. the inner diameter of the passage of the sealing member may advantageously be characterized by a smaller dimension relative to the outer diameter of the part of the cannula that is intended to be clamped by the sealing member, and thus the inner diameter of the passage of the sealing member is advantageously adapted to the outer diameter of the cannula.

[0069] Alternatively or additionally to the clamping, the cannula can be materially connected to the sealing element with connection points or connection surfaces, for example by laser welding. For a solid connection, a connection surface that can be formed by an outer surface portion of the cannula with a suitable passage inner wall portion is preferred.

[0070] Complementarily or additionally, the cannula may have a protrusion on its outer surface, for example in the embodiment of a peripheral fin, which in the assembled state can be precisely fitted and engaged with a recess or groove on the opposite side, preferably in the passage of the sealing member, and thus even more effectively prevent axial movement of the sealing member held in the cannula.

[0071] In a preferred embodiment, the cannula passes completely through the passage of the sealing member. In this respect, it may be advantageous if the cannula is flush with the sealing member at least in the assembled state at the place facing the chamber. This has the advantage that during use, the dead volume in the chamber when completely emptied can be kept to a minimum. A small protrusion of the cannula facing the sealing member on the side facing the chamber in the assembled position can, on the other hand, help that the chamber and the cannula can fully communicate with each other and thus that fluid can flow from the chamber into the cannula without the risk of the inlet of the cannula being covered by the sealing member. A protrusion of the cannula of approximately 0.1 mm to 3 mm, preferably a maximum of 2 mm, with respect to the sealing surface on the end side facing the chamber in the assembled position is therefore advantageous.

[0072] The protruding portion of the cannula opposite the sealing member provides the necessary clearance of the cannula relative to the reservoir required for administration of fluid when using a container according to the invention. This exposed length of the needle is advantageously in the range of approximately 0.6 cm (2 / 8 inch) to approximately 5 cm (2 inches) herein.

[0073] The sealing element is preferably made of an elastomeric material. Such a material has a certain flexibility or compressibility under compressive stress and is therefore suitable for sealing the opening. Thus, the sealing element according to the invention may advantageously be attached to the through passage at the tip of the container and can be axially pressed to seal the opening. Thus, when the cannula assembly is attached to the container, the sealing element can tightly and persistently close the gap that occurs between the outer surface of the cannula that projects into or is adjacent to the through passage and the inner wall of the through passage in the area of ​​the syringe.

[0074] In this way, the sealing member may come into contact with the fluid filled in the chamber, for example, a pharmaceutical or cosmetic sample filled in the chamber, so it is advantageous if the elastomeric material of the sealing member is acceptable for use in contact with the pharmaceutical sample. In this way, contamination of the filled fluid can be prevented, resulting in a long durability and shelf life of the fluid filled in the chamber. Suitable elastomeric materials may be, for example, thermoplastic elastomers, in particular butyl rubber, chlorobutyl rubber, bromobutyl rubber or polyisoprene rubber.

[0075] In order to seal the container, typically tapered, tip, particularly effectively, it is advantageous if at least one end face of the sealing element has an annular region surrounding the passage of the sealing element, said annular region forming a sealing surface in a plane perpendicular to the central axis of the sealing element. This sealing surface on the end face side may be flat, but does not have to be flat, for example it may be conically bent towards the center. This sealing surface is preferably arranged on the side facing the container in the assembled position and contacting the end face of the container or the end face of the tip, thereby sealing against the end face of the container or the end face of the tip. In other words, the sealing surface forms a limit stop.

[0076] The geometric design of the surface of the sealing surface on the end face side is thus preferably adapted to the shape of the end face of the tip to be sealed. For example, in the embodiment in which the end face side of the tip to be sealed has a flat annular surface, it may be appropriate to design the sealing surface of the sealing element flat as well. If, for example, the end face side of the tip to be sealed is designed with a sealing surface that is conically elongated towards the center, then an opposite design of the sealing surface of the sealing element, for example a concave shape, may be useful.

[0077] That is, in the assembled position, the sealing surface on the end face side of the sealing member forms a circumferential contact and sealing surface with the end face side of the tip portion and is preferably flat and circumferentially located on the end face of the tip portion and may further protrude into the gap between the cannula and the inner wall, thereby increasing the sealing effect.

[0078] In the assembled state, the cannula may be in communication with the chamber of the container, meaning that fluid can move from the chamber into the cannula and vice versa, in which case the cannula does not protrude significantly into the passage in the tip of the container, and the free space formed between the cannula and the passage is sealed by a sealing member in the end face region of the tip.

[0079] In order to be able to seal the free space, the inner and outer diameters of the sealing member defining the interior and exterior of the sealing area are geometrically adapted to the end face or tip of the container with which it comes into contact in the assembled state.

[0080] In order to ensure a full-surface seal, the annularly formed sealing area is preferably at least 0.5 mm, preferably at least 0.7 mm, particularly preferably at least 1 mm, measured in the radial direction. In one preferred embodiment, the annular sealing area has a radial extent that at least coincides with the radial extension of the end surface of the tip. A slight radial overlap of said end surface by the inward and / or outward annular sealing area may be advantageous in order to create a sealing area as wide as possible as a contact surface between the seal and the tip in the assembled state.

[0081] Advantageously, the inner diameter of the passage of the sealing member is smaller, or at least not larger, than the inner diameter of the through passage of the container, which ultimately corresponds to the gauge size of the cannula.

[0082] It is further advantageous if the outside diameter of the sealing member is designed correspondingly to the outside diameter of the tip, in order to avoid it protruding relative to the tip.

[0083] Typical sizes of containers and tips suitable for the present invention are specified in the ISO 80369-7 standard.

[0084] To further increase the sealing effect, the end-side sealing area can alternatively or additionally be designed with a preferably frustoconical central projection, which can surround the central passage of the sealing element and can, in the assembled state, engage or protrude into the through-passage of the tip at least in its end-side region. In this way, an additional seal can be advantageously generated between the tip and the sealing element, with the advantage that no fluid can enter the gap between the end side of the tip and the sealing element, since the seal between the sealing element and the through-passage is already generated in the through-passage. The projection also allows for better guidance and / or positioning of the cannula in the through-passage and / or relative to the container.

[0085] The preferably frustoconical projection may advantageously be geometrically adapted to the through-passage of the container to be closed. It has proven to be advantageous if the length of the projection in the axial direction is such that in the assembled position the projection projects into the through-passage at least 0.1 mm, preferably at least 1 mm, particularly preferably at least 2 mm, and is not more than 5 mm, preferably not more than 4 mm, particularly preferably not more than 3 mm.

[0086] To achieve an effective sealing effect, the angle between the axis of the frustoconical projection and the outer surface line is at least 1°, preferably at least 8°, particularly preferably at least 10° to 30°.

[0087] Also in this case, self-centering during assembly of the cannula assembly and the container is advantageous.

[0088] It is an object of the present invention to provide a prefillable and / or pre-filled container according to the present invention for storing and / or administering a fluid, e.g. a pharmaceutical or cosmetic product, by firmly and permanently connecting a cannula assembly comprising a cannula and a sealing member to a container, in particular a syringe, a syringe body, a cartridge or the tip of an injection device.

[0089] In one further aspect of the invention, an adapter is proposed for the tightly and durably sealed connection of a cannula, in particular a cannula assembly, to a container, in particular a syringe, a syringe body, a cartridge or the tip of an injection device, by means of which the cannula can be tightly and durably sealed connected to the container, so that the above-mentioned demands, in particular with regard to storage capacity and / or sterility requirements, can be strictly observed.

[0090] The adapter according to the invention facilitates in a particularly simple manner the provision of the axial and / or radial compression required for a tight and permanently sealed connection of the cannula assembly to the receiver.

[0091] In order to be able to fill, close and reopen such containers, in particular syringes, syringe bodies, cartridges or injection devices, connection systems based on so-called luer lock connections have been developed for the medical field. A container usable for storing and administering pharmaceutical samples comprises a first part of a luer lock connection and can be closed by a closure having a second part of the luer lock connection and can be opened at a later date to administer the sample. This type of connection based on the luer lock principle is advantageously used in the present invention.

[0092] A luer lock coupling includes a coupling member with an internal thread as a first part of the luer lock coupling, which coupling member can be engaged by a second coupling member with an external thread and locked by a rotational movement about a rotation axis. The coupling member with the internal thread is referred to as the male component of the luer lock coupling, and the coupling member with the external thread is referred to as the female component of the luer lock coupling.

[0093] The inventors have discovered that such a coupling principle for opening and closing a container is also particularly suitable for coupling a cannula to a container.

[0094] The subject of the present invention therefore, in one further aspect, is an adapter for connecting a cannula, in particular a cannula assembly, to the tip of a container, in particular a container such as a syringe, a syringe body, a cartridge or an injection device, which adapter is an embodiment of an elongated hollow body with an axial passage opening, one proximal end and one distal end, the inner diameter of the passage opening being enlarged at the proximal end to form a holder for holding a sealing member, and further the proximal end having an external thread as a luer lock connection part, which is or can be connected to an internal thread of the container.

[0095] In this case, the terms "proximal" and "distal" define the respective end sides of the adapter which correspond to the respective end sides of the container, e.g., a syringe, in the assembled position, where the proximal end of the adapter faces, e.g., towards the user.

[0096] The axial passage opening is therefore designed to have at least two different inner diameters, with the enlarged inner diameter opening towards the side of the adapter which faces the container in the assembled position.

[0097] This enlarged inner diameter is advantageously geometrically adapted to the outer diameter of the sealing member of the cannula assembly to be incorporated, thereby allowing the sealing member of the cannula assembly to slide at least partially into the adapter in the axial direction starting from the end face side up to a limit stop formed by the transition of the passage opening with the enlarged diameter to a passage opening with a smaller diameter, thereby preventing further insertion of the sealing member.

[0098] The smaller inner diameter is selected so that in the assembled position the seal member is retained in its intended position as opposed to allowing a cannula to pass through the passage opening in this area.

[0099] Alternatively or additionally, an additional form-locking connection can be formed, i.e. a connection created between the inner wall of the passage and the sealing element by the connection of at least two connecting partners, for example by means of a circumferential groove, which can be dimensioned such that an outer portion of the sealing element can engage in the assembled state. In this way, the sealing element can be held in the adapter, so that an axial offset of the sealing element relative to the adapter is prevented in both directions.

[0100] An additional embodiment also provides for the bond between the cannula assembly and the adapter to be produced in a material-sealed manner, that is, atomic or molecular forces provide the bond between the binding partners.

[0101] The cannula assembly is preferably inserted into the adapter before the adapter is placed into the receiver and screwed together.

[0102] The proximal end of the adapter is further preferably provided with an external thread for a tight connection with the container, which is particularly useful if the external thread is designed as the (female) part of a luer lock connection and facilitates connection with the (male) part of the luer lock connection of the container having a respective internal thread.

[0103] In this way the adapter can be used to connect the cannula to the reservoir and thereby seal the distal opening of the reservoir.The adapter according to the invention has the great advantage that it can be used with a large number of reservoirs available on the market, in particular syringes, syringe bodies, cartridges or injection devices, which are equipped with a (male) Luer lock connection with an internal thread.

[0104] Of course, it is also possible to provide an adapter with other thread designs, so that the adapter can be used with containers with threads other than the Luer Lock principle.

[0105] For coupling and closure, the adapter - preferably with the cannula assembly already inserted - can be placed in the luer lock coupling of the container and screwed in one rotating movement. The limit stop at the passage opening is preferably designed in such a way that when the closure system is screwed on, the sealing member is forced into the intended end position with a defined axial and / or radial contact pressure against the tip of the container, thus creating the desired sealing effect, sealing the through-passage of the container against the cannula.

[0106] In one preferred embodiment, a separate protective means is provided to secure and seal the cannula itself at its distal end protruding from the adapter in the assembled position, thereby achieving the required long term sterile storage capability.

[0107] Thus, the present invention further provides for a attachable closure cap, which may have, for example, a hard exterior region and a sealing elastomeric interior region. The closure cap may be disposed at the distal end of the adapter such that the protruding portion of the cannula (40) is at least partially surrounded and thus sealed by the sealing elastomeric interior region. Thus, in one preferred embodiment, the distal end of the adapter is provided with an extension for attaching and retaining the closure cap.

[0108] In one particularly preferred embodiment, the prefillable or pre-filled container therefore has a closure cap designed - in the installed position - to seal the passage of the cannula against the surrounding environment and thus ensure a stable long-term sterile storage capability. When the sealing cap is installed, the cannula can for example slide into a sealing elastomer material in the inner area of ​​the sealing cap, which when the closure cap is installed exerts a slight pressure axially and / or radially against the opening of the cannula, thereby closing said cannula.

[0109] The adapter and cannula assembly may be manufactured and stored together as an assembly group and then coupled to the container. In this way, the adapter and cannula assembly form a closure system for the container, which may be flexibly configured, for example with different cannulas. In one advantageous design, the closure system may already include the closure cap described above.

[0110] One advantageous further refinement of the invention provides an adapter and / or closure cap with a predetermined color scheme that depends on at least one characteristic of the cannula, preferably on the outer diameter, inner diameter, length and / or type of bevel grinding of the cannula.

[0111] The color system is set out, for example, in the standard EN ISO 6009, which specifies the colors according to the gauge size of the cannula. In this way, the color of the adapter and / or the color of the closure cap can be used in a particularly advantageous way to provide the user with direct information regarding the outer diameter of the cannula. This can improve safety and access times.

[0112] In one preferred embodiment, the color of the adapter and / or closure cap corresponds to a color code according to the ISO 6009 standard in order to give the user information about the outer diameter and thus the gauge size of the cannula. In this way, the user of a prefillable or prefilled container according to the invention can quickly receive information about the characteristics of the cannula and can easily and reliably select the container required for a particular administration.

[0113] Color schemes may also be combined, for example a first color designation for the adapter to provide a user with information regarding the outer diameter or gauge size of the attached cannula, and a second color designation for the closure cap to provide information regarding, for example, the type or length of the bevel grind of the cannula.

[0114] The closure system according to the present invention - preferably with a cannula assembly already inserted - can be used with pre-fillable or pre-filled containers for storing and administering fluids, in particular pharmaceutical or cosmetic samples, whereby the through passage of the container can be sealed and a cannula can be attached.

[0115] In this way, a prefillable or pre-filled container, in particular a prefillable or pre-filled syringe, a prefillable or pre-filled syringe body, a prefillable or pre-filled cartridge or a prefillable or pre-filled injection device can be provided in an extremely simple "ready to use" state for storing and / or administering a fluid, in particular a pharmaceutical or cosmetic sample.

[0116] Therefore, suitable containers according to the invention are commercially available syringes, syringe bodies, cartridges or injection devices, preferably equipped with an internally threaded (male) Luer lock connection.

[0117] A major advantage of the present invention is that these containers can be mass-produced cost-effectively, without the need for a suitable cannula to be provided and attached to the container already during its manufacture.

[0118] Such containers are often made from synthetic materials and are manufactured in an injection molding process, which greatly simplifies their manufacture, and, moreover, handling during manufacture is obviously much easier, since no handling of the container with the cannula attached is required.

[0119] Additionally, it is much easier to provide a wide variety of container sizes and cannulas without expensive storage requirements due to the fact that the present invention allows containers and cannulas to be manufactured, stored and shipped independently of one another and then coupled together depending on the intended use.

[0120] This means that containers having volumes of, for example, 0.25 ml, 0.5 ml, 0.6 ml, 1.0 ml, 1.2 ml, 1.5 ml, 2.0 ml, 2.25 ml, 3.0 ml, 5.0 ml, 10 ml, 20 ml or 50 ml can be very easily coupled to cannulas of various gauge sizes, for example 27, 28, 29, 30 G, in particular 31, 32, 33 or 34 G gauge cannulas which have a very small outer diameter.

[0121] Tooling costs as well as storage may be reduced since the container can be manufactured regardless of cannula size.

[0122] A suitable container according to the present invention may be manufactured as a single component from a transparent material, preferably glass or a synthetic material, which may include a thermoplastic or thermosetting synthetic material.

[0123] It is of course also possible to manufacture the container from more than one material, as described, for example, in the publication DE 10 2014 211 018 A1, the contents of which in this respect are also the subject of the present application. The embodiment of the container for pharmaceutical samples described in this publication makes use of the very good inert properties of glass in contact with other substances and at the same time allows for connection to a Luer lock connection, in this case a connection made of a synthetic material is provided.

[0124] The thermoplastic synthetic material may include acceptable synthetic materials commonly used in the medical field, and thus may be or include cycloolefin copolymer (COC), cycloolefin polymer (COP), acrylonitrile butadiene styrene (ABS), polyamide (PA), polylactic acid (PLA), polymethyl methacrylate (PMMA), polycarbonate (PC) or polyethylene terephthalate (PET).

[0125] Suitable acceptable thermosetting synthetic materials commonly used in the medical field may comprise or consist of cellulose acetate (CA) or transparent thermosetting resins.

[0126] Suitable glasses have the following composition (by weight): SiO265%~82% B2O35%~13% ΣNa2O+K2O 4%~10% Al2O3 2%~9% ΣCaO+MgO+BaO+SrO 0%~5% The glass may be a borosilicate glass having the following properties:

[0127] Such glasses are preferably: SiO2 73%~79% B2O39%~12% Na2O 5%~8% K2O 0%~0.5% Li2O 0%~0.3% Al2O33.5%~7% CaO 0%~3% BaO 0%~1% F 0~0.3% ΣCaO+MgO+BaO+SrO 0%~3% The composition (wt %) may be as follows:

[0128] In an additional embodiment, such a glass comprises: SiO2 71%~77% B2O39%~12% Na2O 5.5%~8.5% K2O 0.1%~1.0% Li2O 0%~0.3% Al2O35.5%~8% CaO 0%~1.5% BaO 0%~1% F 0~0.3% ΣCaO+MgO+BaO+SrO 0%~2% The composition (wt %) may be as follows:

[0129] The prefillable or prefilled container according to the invention is further characterized in that the contact pressure of the sealing element in the assembled position, in particular on the end face side of the tip, is at least 0.1-30 N, preferably 5-20 N. The prefillable container according to the invention is further characterized in that the contact pressure of the sealing element in the closure cap, in the assembled position, on the end of the cannula, is at least 20 N, preferably at least 30 N.

[0130] Based on the interaction of both seals, long-term storage is possible with regard to stability and, if the container is sterilized, also with regard to sterility.

[0131] To further increase the sealing effect, the sealing area on the end side can alternatively or additionally be designed with a frustoconical central projection, which in one preferred embodiment interacts with the through-passage at the tip of the container in the assembled position. In other words, the projection of the sealing element protrudes at least partially into the through-passage of the container to be sealed. A good seal can be achieved if the projection protrudes into the through-passage by at least 0.1 mm, preferably at least 1 mm, particularly preferably at least 2 mm, but not more than 5 mm, preferably more than 4 mm, particularly preferably more than 3 mm.

[0132] The engagement of the projection into the through passage provides an additional advantage since it keeps the sealing member in place. Semicircular projections are also possible and may be used primarily for centering within the through passage.

[0133] The present invention therefore also relates to a pre-filled container comprising a syringe, syringe body, cartridge or injection device with a very thin cannula for injecting a fluid, such as a medicine or a cosmetic product. The cosmetic product may comprise, for example, a cosmetic compound. The present invention thus allows the container to be very simply coupled to a cannula having a gauge size larger than 30G, preferably 31G, 32G, 33G or 34G.

[0134] The pre-filled container may be filled with a fluid or liquid, for example a pharmaceutical sample or preferably a liquid cosmetic compound. Thus, the present invention may also provide a container pre-filled with a fluid or liquid, preferably a cosmetic compound, characterized in that the cannula 40 has a gauge size greater than 30G, preferably 31G, 32G, 33G or 34G.

[0135] Therewith the present invention also provides a method comprising the step of injecting or administering a fluid, such as a pharmaceutical or cosmetic product, from or using a pre-filled "ready to use" container according to the present invention, preferably using a cannula having a gauge size greater than 30G, preferably 31G, 32G, 33G or 34G.

[0136] The present invention also encompasses a cosmetic procedure comprising the step of injecting or administering a cosmetic compound using a pre-filled container according to the present invention, where the chamber is filled with a liquid, preferably the cosmetic compound, and the cannula has a gauge size greater than 30G, preferably 31G, 32G, 33G or 34G.

[0137] The invention provides pre-filled containers according to the invention which can be stored for at least one year after filling, preferably at least two years, particularly preferably at least three years or even more than three years, providing that appropriate sterility requirements are strictly observed.

[0138] In this case, it is advantageous if the above-mentioned assembly is X-ray or gamma ray resistant and thus amenable to X-ray or gamma ray sterilization to eliminate microbial contamination within the pre-fillable or pre-filled container.

[0139] In another advantageous embodiment, the above-described assembly is heat resistant up to 121° C. and may therefore be autoclaved.

[0140] Depending on the sample, the filled, in particular pre-filled, container can then also be sterilized together with the sample, which can greatly contribute to improving the storage capacity, since in this case the bacteria in the container can generally be eliminated with high certainty.

[0141] In order to prevent manipulation, for example of pre-filled containers equipped with the closure system according to the invention, a further refinement of the invention proposes providing a form-locking coupling, in other words a Luer lock coupling resulting from the engagement of at least two coupling partners with each other, which has the additional purpose of preventing unintentional opening and reclosing and / or other manipulations.

[0142] In one embodiment, a cover in the form of a seal or band may be provided that surrounds and couples together at least an outer surface portion of the adapter and an outer surface portion of the container. The cover may be designed such that the rotational action of the adapter to open the container will damage the cover and be noticeable by the user. Thus, the possibility of the container being opened and reclosed by rotation of the closure system may be prevented. Thus, an opened container is easily noticeable.

[0143] In a further or additional embodiment, the luer lock connection which is separable by a rotational movement is further improved to a non-separable luer lock connection. This can occur, for example, by forming a material-tight connection in addition to the luer lock connection, i.e. a connection based on a bond between the bond partners by atomic or molecular forces, i.e. between the closure system and the container, which preferably interacts with the luer lock connection or the additional connection. For this purpose, a material-tight connection point or a material-tight connection surface can be generated between the outer thread and the inner thread, for example by applying an adhesive, by laser welding or by UV welding, in which case the additional connection hardens when the container is closed.

[0144] Thus, the luer lock connection can be surprisingly easily converted into a non-separable connection, so that it can be ensured that the container pre-filled with fluid and the filled fluid cannot be manipulated.

[0145] Further details of the invention are set out in the description of the illustrated design examples and in the appended claims. [Brief description of the drawings]

[0146] [Figure 1] FIG. 1 is a cross-sectional view of a cannula assembly, adapter and closure cap including a container, a sealing member and a cannula as the main components of one preferred design example of a prefillable or pre-filled container according to the present invention, the cross-section being taken through approximately the center of each of said components, with their centerlines indicated. [Diagram 2] FIG. 2 is a cross-sectional view of a container with a cannula assembly including a seal member and a cannula, the cross-section being taken approximately through the center of these components with their centerlines indicated. [Diagram 3] FIG. 3 is a cross-sectional view of the cannula assembly shown in FIG. 2, the cross-section being taken approximately through the center of the cannula assembly with the centerline indicated. [Figure 4]FIG. 2 is a cross-sectional view of one preferred design adapter, the cross-section being taken approximately through the center of the adapter with the centerline indicated. [Diagram 5] FIG. 5 is a cross-sectional view of a closure system including the cannula assembly shown in FIG. 3 and the adapter and closure cap shown in FIG. 4, the cross-section being taken approximately through the centers of these components with their centerlines indicated. [Figure 6] FIG. 2 is a cross-sectional view of the container in the form of a syringe, the cross-section being taken through approximately the center of the container, with the centerline indicated. [Figure 7] FIG. 7 is a cross-sectional view of one preferred design example of a pre-fillable container including a container as shown in FIG. 6 and a closure system as shown in FIG. 5, the cross-section being taken through approximately the center of the container with the centerline indicated.

[0147] Detailed Description of the Preferred Embodiments In the following detailed description of the preferred embodiments, substantially identical components in these embodiments are labeled with the same reference numerals for clarity, however, in order to better clarify the present invention, the preferred embodiments shown are not necessarily drawn to scale.

[0148] FIG. 1 is a cross-sectional view of one design example, showing a container 10, a cannula assembly 20 including a sealing member 30 and a cannula 40, an adapter 60 and a closure cap 70 as the main components of a pre-fillable or pre-filled container 1 according to the present invention for storing and / or administering a fluid, in particular a pharmaceutical or cosmetic sample.

[0149] The container 10, in the example shown, and without being limited to the illustrated design, is a syringe with an internally threaded Luer lock connection and a chamber volume of 10 ml.

[0150] In summary, there is disclosed a pre-fillable or pre-filled container 1 for storing and / or administering a fluid, in particular a pharmaceutical or cosmetic product, comprising a receptacle 10 with a chamber 13 for containing the fluid, in particular a syringe, cartridge or injection device with a syringe body, further a cannula assembly 20 attachable to the receptacle 10, comprising a cannula 40 and a sealing member 30, and a closure cap 70, wherein the external passage opening 43 of the cannula 40 protrudes into a seal, preferably into an elastomeric inner area 72 of the closure cap 70 which seals the passage opening 43, and wherein the chamber 13 is sealed fluid-tight due to radial and / or axial compression of the sealing member 30 by the closure cap 70 and sealing of the passage opening 43.

[0151] In other words, the present invention discloses a size-flexible, cannula-flexible, pre-assembled, pre-filled syringe with a Luer lock or a stack needle with an adapter pre-attached to the Luer lock with a long-term seal, which - as a modular design - is suitable for integration into the system with all types of cannulas, especially very thin cannulas (e.g. 31-34G).

[0152] According to the invention, the adapter 60 according to the invention and the cannula assembly 20 according to the invention can be used with a number of different containers 10, including syringes, syringe bodies, cartridges or injection devices with different chamber volumes, preferably ranging from 0.6 ml to 50 ml, made of glass or synthetic material. The container 10 has a Luer lock connection with an internal thread 11 in this design example.

[0153] The cannula assembly 20 and adapter 60 are used to connect the cannula 40 to the container 10 to enable the use of a prefillable or pre-filled container 1 according to the invention for storing and / or administering a fluid, such as a pharmaceutical or cosmetic product. The container 1 can be filled with a fluid, and the pre-filled container can be stored before the fluid is administered through the cannula 40. The container 10 in this design has a vertical cylindrical shape and has a central chamber 13 for containing a fluid. The chamber 13 is axially defined by a proximal end 15 and a distal end 14. In use, the distal end 14 faces the person handling the device.

[0154] The descriptions "distal" and "proximal" are used similarly with respect to additional components of the container 1 according to the invention and the respective sides or directions of said components in the assembled position.

[0155] The proximal end 15 of the chamber 13 has an opening 16 into which a stopper can be inserted and actuated, for example via a piston rod or hydraulically, to move the stopper axially out of the chamber 13 towards the opposite distal end 14, thereby displacing the filled fluid. In the reverse movement, fluid can be drawn into the chamber 13.

[0156] For this purpose, the distal end 14 of the container 10 is provided with a through passage 17 surrounded by the tip 12. Fluid (not shown) filled in the chamber 13 can then be removed through said through passage 17 upon each stopper movement, or fluid may be drawn into the chamber 13 through said through passage 17 upon the opposite stopper movement. The dotted line marked 18 represents the central axis of the container 10, which also represents the reference axis of additional components.

[0157] Cannula assembly 20 represents a major component of the present invention, an example of which is shown diagrammatically in cross-section in FIG.

[0158] 2 additionally shows a cross-sectional view of the container 10 with the cannula assembly 20 including the sealing member 30 and the cannula 40. The cannula assembly according to the embodiment shown in Figs. 2 and 3 has a cylindrically symmetrical sealing member 30 with an axial passage 31 and a cannula 40 with a through passage 41, the cannula 40 being arranged at least partially in the internal passage 31 coaxially with the sealing member 30 and a part of the outer surface area 42 of the cannula 40 being firmly connected to the sealing member 30 in a form-locking and / or material-sealing manner, and at least one end side 33 of the sealing member 30 includes an annular area surrounding the passage 31, which annular area forms an end-side sealing surface 32 in a plane perpendicular to the central axis 18 of the sealing member 30.

[0159] As mentioned above, a material-sealed bond here refers to a bond between the binding partner members by atomic or molecular forces, whereas a form-sealed bond refers to the joining of at least two binding partners, which are in intimate contact with one another and also provide a fluid-tight seal based on this intimate contact.

[0160] The axial passage 31 of the sealing element 30 is used to accommodate a cannula 40, i.e. a hollow needle or injection needle with a through passage 41, which may be suitably used in the medical field. The connection between the sealing element 30 and the cannula 40 is here liquid-tight and / or gas-tight within the meaning of the present invention.

[0161] The invention allows in a particularly advantageous manner the use of cannulae with sizes from 27 G to 30 G, preferably 31 G and 32 G, particularly preferably 33 G and 34 G and above, which is particularly advantageous with regard to the patient-friendly administration of pharmaceutical samples.

[0162] Due to the extremely small cannula diameters available according to the invention, the patient is now exposed to a significantly reduced pain sensation during the injection or withdrawal of bodily fluids, which supports in an extremely advantageous manner the injection or administration of medical samples in oral surgery, in particular the injection of anesthetics into the oral cavity of the patient, since the oral cavity is known to be particularly susceptible to increased pain sensations.

[0163] The injection or administration of medical materials in ophthalmology, particularly for suppressing a patient's eyelid reflex or for dilating the pupils, is also greatly aided, since the small cannula diameters available according to the invention result in very little wounds or tissue damage, which in experience heals very quickly.

[0164] When injecting or administering medical samples in nephrology, especially when administering marker substances to follow fluid dynamic processes, it is now possible to reach extremely small blood vessels and achieve greater precision even with robotically 3D controlled administration in the acquisition of fluid dynamic processes.

[0165] Substantially the same advantages arise in the injection or administration of medical samples in nuclear medicine, for example the administration of radioisotopes in the treatment of tumors, where the active substance of each sample can be administered locally and quantitatively more accurately metered, causing less pain.

[0166] Thanks to the subject matter of the present invention, the injection or administration of cosmetic products, such as products based on hyaluronic acid or Botox, also becomes less unpleasant.

[0167] Thus, advantageously, the use of pre-filled containers as disclosed herein is recommended for the sterile storage of pharmaceutical or cosmetic samples for periods of one year or more, preferably two years or more, and particularly preferably three years or more.

[0168] In the illustrated design, only a 34G size cannula is shown.

[0169] In the assembled position, the cannula 40 is located in the sealing element 30 and passes completely through it. In this design, the protrusion on the end side with the sealing surface 32 is approximately 0.2 mm, whereby a protrusion in the range of 0.1 mm to 3 mm, preferably a maximum of 2 mm, is advantageous in order to prevent the sealing element from covering the inlet for the hollow needle.

[0170] In this design example, the opposite overhang is approximately 4 cm, where a overhang in the range of approximately 0.6 cm (2 / 8 inch) to approximately 5 cm (2 inches) is advantageous to provide the necessary free space for the cannula 40 relative to the container 10 during use.

[0171] The seal member 30 is made from an elastomeric material, including a thermoplastic elastomer, particularly butyl rubber, chlorobutyl rubber, bromobutyl rubber, or polyisoprene rubber, and is approved for use in contact with pharmaceutical samples.

[0172] In order to be able to provide a sufficiently large sealing area between the end face side of the tip portion 12 and the end face sealing surface 32, the end face sealing surface 32 is characterized by a radial extension of approximately 0.8 mm, in which case an extension of at least 0.5 mm, preferably at least 0.7 mm, and particularly preferably at least 1 mm, is considered advantageous.

[0173] To further improve the sealing action and achieve radial compression in addition to axial compression during sealing, this design is provided with a central projection 36 on the sealing surface 32. In this design, this projection 36 is of a frusto-conical design, which in particular facilitates a self-centering easy joint during the mating process of the cannula assembly 20 and the receiver 10, as well as ensuring uniform radial compression.

[0174] The radial compression - particularly in the embodiment with frusto-conical projections 36 - can be influenced by the slope or angle between the central axis 18 of the sealing member and the outer surface line of the frusto-conical projection, which is preferably at least 1°, preferably at least 8°, particularly preferably at least 10°-30°.

[0175] In the mounted position, the central projection 36 at least partially engages within the through passage 17 or projects into the through passage 17 .

[0176] In this way, an increased sealing action between the opening of the through passage 17 and the sealing member 30 can be easily achieved, with the additional advantage that no fluid can flow into the gap between the end face side of the tip portion 12 and the sealing member, since the seal between the sealing member 30 and the through passage 17 is already generated within the through passage 17 itself.

[0177] The cannula assembly 20 can be attached to the distal end 12 of the receiver 10. The retention of the cannula assembly 20 in the distal end 12 and the necessary compression in the axial and / or radial directions is provided by an adapter 60 according to the invention, one design example of which is shown in cross section in FIG.

[0178] The adapter 60 and the cannula 20 together may form a closure system 50 according to the invention for a container 10 for producing a prefillable or prefilled container 1. The closure system 50 shown in cross section in Figure 5 includes a cannula assembly according to the design example shown in Figure 3 and an adapter according to the design example shown in Figure 4. The closure system 50 shown in Figure 5 further includes a closure cap 70 placed and held on the adapter 60.

[0179] The adapter 60 is used to connect the cannula 40 to the container 10. The adapter 60 is designed in the embodiment of an elongated hollow body with an axial passage opening 61, a proximal end 65 and a distal end 64, the inner diameter of the passage opening 61 being enlarged at the proximal end 65 to form a holding body 66 for holding the sealing member 30, and the proximal end 65 further having an external thread 62 as a luer lock coupling part, which is or can be coupled to the internal thread 11 of the container 10. Elongated here means that the adapter 60, which complies with at least the standards cited below, has the length of the luer lock, also called luer lock external thread or female coupling part, in the direction of the center line 18.

[0180] The outer thread 62 of the adapter 60 is designed as the (female) part of a Luer lock coupling and complies with the ISO 11040, ISO 80369-1 or ISO 80369-7 standards.

[0181] The retainer 66 is geometrically adapted to the outer geometry of the seal member 30 of the cannula assembly 20 that must be accommodated, thus allowing the seal member 30 to slide at least partially into the adapter 60 in the axial direction starting from the end side up to a limit stop 63, which is formed by the transition of the passage opening with the enlarged inner diameter to a passage opening with a smaller inner diameter, thereby preventing further insertion of the seal member 30. In this design example, the retainer 66 is designed to taper conically in order to match the outer contour of the seal member 30. This allows the seal member 30 to slide into the retainer 66 with little force and to be radially centered within the retainer 66.

[0182] The adapter 60 of this design also has an extension 67 that allows a closure cap 70 to be placed on the distal end 64 and to be held in the intended position. The closure cap 70 is designed to protect the part of the cannula 40 that protrudes relative to the adapter - in the assembled position - and to close the external passage opening 43 of the passage 41 of the cannula 40 tightly, in other words liquid-tightly and / or fluid-tightly, within the meaning of the present invention.

[0183] The adapter 60 of this design further includes a mounting ring 68, which is an embodiment of a hexagonal ring. The mounting ring 68 aids in handling and simplifies user installation onto the container 10.

[0184] In the design shown in Fig. 5, the cannula assembly 20 is inserted into the adapter 60 up to the intended position. In this design, the closure cap 70, which rests on the adapter 60 and is held by the extension 67, has a hard outer region 71 and a sealing elastomeric inner region 72. The part of the cannula 40 which protrudes relative to the adapter 60 protrudes at least partially into the elastomeric inner region 72 of the closure cap 70. To ensure a reliable seal, the cannula 40 - in the assembled position - should protrude at least 2 mm, preferably at least 3 mm, particularly preferably 4 mm or more into the elastomeric inner region 72. In this case, when the closure cap 70 is installed and sealed within the meaning of the invention, the elastomeric material 72 exerts a slight pressure axially and / or radially on the cannula opening 43 of the cannula 40.

[0185] Said seal makes it possible to seal the passageway 41 of the cannula 40 liquid-tight and / or gas-tight against the surrounding environment. In this way, a stable sterile long-term storage capability can also be ensured.

[0186] 6 shows a cross-sectional view of a syringe as an example of a suitable container 10 according to the invention. The container 10 in this example is made of a transparent material, for example the thermoplastic synthetic material cycloolefin polymer (COP). Other materials for the container 10 are also contemplated, for example thermosetting materials or glass.

[0187] Suitable thermoplastic materials include cycloolefin copolymer (COC), cycloolefin polymer (COP), acrylonitrile butadiene styrene (ABS), polyamide (PA), polylactic acid (PLA), polymethyl methacrylate (PMMA), polycarbonate (PC) or polyethylene terephthalate (PET).

[0188] Suitable thermosetting synthetic materials include cellulose acetate (CA) or clear thermoset resins.

[0189] Suitable glasses preferably include: SiO265%~82% B2O35%~13% ΣNa2O+K2O 4%~10% Al2O3 2%~9% ΣCaO+MgO+BaO+SrO 0%~5% The borosilicate glass has a composition (wt %) of:

[0190] In FIG. 7, another cross-sectional view of a pre-fillable container 1 for storing and / or administering a fluid, such as a pharmaceutical or cosmetic product, is shown.

[0191] The prefillable container 1 according to the invention comprises a container 10 - a syringe in the example shown in FIG. 2 or FIG. 6 - a closure system 50 with a cannula assembly 20 according to the design example shown in FIG. 3, mounted as shown in FIG. 5, and an adapter 60 according to the design example shown in FIG. 4.

[0192] By way of example only, a stopper 19 is shown closing the opening 16 at the proximal end 15 of the container. A fluid, such as a pharmaceutical or cosmetic product, may be filled into the chamber 13.

[0193] The closure system 50 and the container 10 are connected to each other by a Luer lock connection. In the assembled position, the cannula 40 is in fluid communication with the container chamber 13. The adapter 60 allows for a tight, permanent, and secure connection of the cannula 40, preferably a cannula having a gauge size greater than 30G, preferably 31G, 32G, 33G or 34G, to the container 10.

[0194] In the assembled position, the closure system 50 generates a contact pressure of the sealing member 30 against the end face side of the tip portion 12 of at least 0.1-30N, preferably 5-20N.

[0195] The invention allows in a particularly simple manner the coupling of the container 10, whereby a prefillable or prefilled container 1 according to the invention is provided.

[0196] In the case of a pre-filled container 1 according to the invention, the chamber 13 is at least partially filled with a fluid, which may also comprise a pharmaceutical sample or preferably a liquid cosmetic sample.

[0197] According to the present invention, a container 1 pre-filled with a liquid, preferably a cosmetic sample, may also be provided, characterized in that the cannula 40 has a gauge size greater than 30G, preferably 31G, 32G, 33G or 34G.

[0198] The present invention further provides a cosmetic treatment comprising the injection or administration of a cosmetic sample using a pre-filled container 1, where the chamber 13 is filled with a liquid, preferably a cosmetic sample, and the cannula 40 has a gauge size greater than 30G, preferably 31G, 32G, 33G or 34G. [Explanation of symbols]

[0199] 1 Prefillable or prefilled containers 10 Container 11 Luer Lock Internal Thread 12 Tip 13 rooms 14 Distal end 15 Proximal end 16 Aperture 17 Passage 18 Center axis 19 Stopper 20 Cannula Assembly 30 Sealing material Aisle 31 32 End face sealing surface 33 End side 34 Distal end 35 Proximal end 36 Protrusion 37 Outer surface line 40 Cannula Aisle 41 42 Exterior 43 Cannula opening 50 Closure System 60 Adapter 61 Passage opening 62 External Thread 63 Limit Stop 64 Distal end 65 Proximal end 66 Holding body 67 Extended part 68 Mounting ring 70 Closure Cap 71 External area 72 Elastomer inner region

Claims

1. A pre-fillable or pre-filled container (1) for storing and / or administering a fluid, comprising: a container (10) having a chamber (13) for containing said fluid; a cannula assembly (20) including a cannula (40) having an external passage opening (43) and a seal member (30), said cannula assembly (20) being mountable to said container (10), said seal member (30) having at least one end side (33) which, in a mounted position, faces said container (10) and includes a passage (31) surrounded by an annular area forming an end side sealing surface (32) in a plane perpendicular to a central axis (18) of said seal member (30), said cannula (40) terminating flush with said seal member (30) at a portion of said at least one end side (33) which, in said mounted position, faces said chamber (13); a closure cap (70) having a seal; Equipped with The external passage opening (43) of the cannula (40) projects into the seal of the closure cap (70), thereby sealing the external passage opening (43); the chamber (13) is sealed fluid-tight by radial and / or axial compression of the sealing member (30) by the closure cap (70) and sealing of the external passage opening (43); the annular area forming the end face sealing surface (32) is 0.5 mm to 1 mm, measured radially; the container (10) has a body with a proximal end (15) and a distal end (14), the distal end (14) having an axial through passage (17) with a tip (12), the tip (12) surrounding the through passage (17); The end sealing surface (32) has a frustoconical projection (36) surrounding the passage (31) and projecting into the through passage (17); the angle between the axis of the frustoconical projection (36) and the outer surface line (37) of the frustoconical projection (36) is at least 1°, and the projection (36) protrudes into the through passage (17) by at least 0.1 mm; A prefillable or prefilled container (1).

2. The distal end (14) has an internal thread (11) as a luer lock coupling portion, the sealing member (30) comprises a cylindrically symmetrical sealing member (30) with the passage (31), the passage (31) being an axial passage (31), the cannula (40) is arranged coaxially with the sealing member (30) and at least partially within the axial passage (31) of the sealing member (30), and a portion of an outer surface area (42) of the cannula (40) is firmly coupled to the sealing member (30) in a material-sealing and / or form-locking manner, The prefillable or prefilled container (1) comprises: The cannula assembly (20) is further provided with an adapter (60) for coupling the cannula assembly (20) to the tip (12) of the container (10), the adapter (60) being in the form of a hollow body with an axial passage opening (61), a proximal end (65) and a distal end (64), the inner diameter of the axial passage opening (61) being enlarged at the proximal end (65) of the adapter (60) to form a retainer (66) for retaining the seal member (30), and the proximal end (65) of the adapter (60) being enlarged to form a retainer (66) for retaining the seal member (30).

2. The prefillable or pre-filled container (1) of claim 1, wherein the cannula assembly (20) has an external thread (62) which is coupled or capable of being coupled to the internal thread of the container (10), and in the mounted position the cannula assembly (20) is inserted into the retainer (66) and seals the through passage (17) when the adapter (60) is coupled to the container (10), and in the mounted position the cannula (40) is in communication with the chamber (13).

3. The prefillable or pre-filled container (1) according to claim 2, wherein the contact pressure of the sealing member (30) applied to the end face side of the tip portion (12) in the mounting position is at least 0.1-30N.

4. 4. The prefillable or pre-filled container (1) of claim 3, wherein the adapter (60) has an extension (67) at the distal end (64) thereof for mounting and retaining the closure cap (70).

5. 5. The prefillable or pre-filled container (1) according to any one of claims 1 to 4, wherein the container (10) is made of a transparent material or a synthetic material, including a thermoplastic or thermosetting synthetic material.

6. 6. The prefillable or prefilled container (1) according to claim 5, wherein the thermoplastic synthetic material comprises or consists of Cycloolefin Copolymer (COC), Cycloolefin Polymer (COP), Acrylonitrile Butadiene Styrene (ABS), Polyamide (PA), Polylactic Acid (PLA), Polymethyl Methacrylate (PMMA), Polycarbonate (PC) or Polyethylene Terephthalate (PET).

7. 6. A prefillable or pre-filled container (1) according to claim 5, wherein the thermosetting synthetic material comprises or consists of cellulose acetate (CA) or a transparent thermosetting resin.

8. the transparent material is glass; The glass has the following composition (by weight): Yes ２ 65% to 82% B ２ O ３ 5%~13% ΣΝή ２ O+K ２ O 4%~10% <h2 style=";text-align:left;direction:ltr">Al<h2 style=";text-align:left;direction:ltr"> ２ <h2 style=";text-align:left;direction:ltr"> O<h2 style=";text-align:left;direction:ltr"> ３ <h2 style=";text-align:left;direction:ltr"> 2%~9% ΣCaO+MgO+BaO+SrO 0%~5% 6. The prefillable or prefilled container (1) according to claim 5, which is a borosilicate glass having the formula:

9. The prefillable or prefilled container (1) according to any one of claims 1 to 8, wherein the cannula (40) has a gauge size of 27G to 30G.

10. 10. The prefillable or prefilled container (1) of claim 1, wherein the cannula (40) protrudes from the sealing member (30) on the side of the end sealing surface (32) by 0.1 mm to 3 mm and / or has a protrusion from the sealing member (30) on the opposite side within a range of 0.6 cm (2 / 8 inch) to 5 cm (2 inches).

11. A prefillable or pre-filled container (1) according to any one of claims 1 to 10, filled with a fluid or liquid, wherein the cannula (40) has a gauge size of greater than 30G.

12. A closure system (50) for coupling a cannula (40) to a container (10), said closure system (50) comprising: A cannula assembly (20) comprising: a cylindrically symmetrical seal member (30) having an axial passage (31); A cannula (40); having the cannula (40) is disposed coaxially with the seal member (30) and at least partially within the axial passage (31) of the seal member (30); a portion of the outer surface area (42) of the cannula (40) is firmly connected to the sealing member (30) in a material-sealing and / or form-fitting manner; and At least one end face side (33) of the seal member (30) includes an annular region surrounding the axial passage (31), and the annular region forms an end face side seal surface (32) in a plane perpendicular to a central axis (18) of the seal member (30); the cannula (40) terminates flush with the sealing member (30) at a portion of the at least one end side (33) that is configured to face the chamber (13) of the container (10) in the mounted position, the annular area forming the end face sealing surface (32) is 0.5 mm to 1 mm, measured radially; the container (10) has a body with a proximal end (15) and a distal end (14), the distal end (14) having an axial through passage (17) with a tip (12), the tip (12) surrounding the through passage (17); The sealing surface (32) on the end face side has a truncated cone-shaped protrusion (36), which protrudes into the through passage (17); the angle between the axis of the frustoconical projection (36) and the outer surface line (37) of the frustoconical projection (36) is at least 1°, and the projection (36) protrudes into the through passage (17) by at least 0.1 mm; A closure system (50).

13. A closure system (50) for coupling a cannula (40) to a container (10), said closure system (50) comprising: A cannula assembly (20) comprising: a cylindrically symmetrical seal member (30) having an axial passage (31); A cannula (40); having the cannula (40) is disposed coaxially with the seal member (30) and at least partially within the axial passage (31) of the seal member (30); a portion of the outer surface area (42) of the cannula (40) is firmly connected to the sealing member (30) in a material-sealing and / or form-fitting manner; and At least one end face side (33) of the seal member (30) includes an annular region surrounding the axial passage (31), and the annular region forms an end face side seal surface (32) in a plane perpendicular to a central axis (18) of the seal member (30); In the mounted position, the cannula (40) protrudes from the sealing member (30) at a portion of the at least one end side (33) that is configured to face the chamber (13) of the container (10); the annular area forming the end face sealing surface (32) is 0.5 mm to 1 mm, measured radially; the container (10) has a body with a proximal end (15) and a distal end (14), the distal end (14) having an axial through passage (17) with a tip (12), the tip (12) surrounding the through passage (17); The sealing surface (32) on the end face side has a truncated cone-shaped protrusion (36), which protrudes into the through passage (17); the angle between the axis of the frustoconical projection (36) and the outer surface line (37) of the frustoconical projection (36) is at least 1°, and the projection (36) protrudes into the through passage (17) by at least 0.1 mm; A closure system (50).

14. The closure system (50) according to claim 12 or 13 further comprises an adapter (60) in the form of a longitudinal hollow body having an axial passage opening (61), a proximal end (65) and a distal end (64), the inner diameter of the axial passage opening (61) being enlarged at the proximal end (65) and forming a retainer (66) for retaining the seal member (30) of the cannula assembly (20), and the proximal end (65) further having an external thread (62) as a luer lock coupling portion.

15. 15. The closure system (50) of claim 14, further comprising a closure cap (70) having a hard exterior region (71) and a sealing elastomeric interior region (72), the closure cap (70) being disposed at the distal end (64) of the adapter (60).

16. Container (1) according to any one of claims 1 to 11 for use in medical or cosmetic procedures including injection or administration of a medical sample in oral surgery and / or injection or administration of a medical sample in ophthalmology and / or injection or administration of a medical sample in nephrology and / or injection or administration of a medical sample in nuclear medicine in the administration of radioactive isotopes and / or injection or administration of a cosmetic sample.

17. Use of a container (1) according to any one of claims 1 to 11 for the sterile storage of pharmaceutical or cosmetic products for a storage period of one year or more.

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