WO2023092168A1

WO2023092168A1 - Receiving device comprising septum, and method for producing same

Info

Publication number: WO2023092168A1
Application number: PCT/AT2022/060418
Authority: WO
Inventors: Christian RATHNER; Gerhard Strasser; Harald Zodl
Original assignee: Greiner Bio-One Gmbh
Priority date: 2021-11-29
Filing date: 2022-11-28
Publication date: 2023-06-01
Also published as: AT525541A4; AT525541B1

Abstract

The invention relates to a receiving device (1) for organic material. The receiving device (1) is composed of a closure device (2) comprising: a cap (3) that has a cap casing (10); and a first sealing device (7) located in the cap (3). The receiving device (1) is also composed of a receiving container (9) that is predominantly cylindrical and encloses an inner space (8). The cap casing (10) of the cap (3) engages, with its open first end region (4) that faces the receiving container (9), around an open end face (11) of the receiving container (9), and at least one sealing surface (12) of the first sealing device (7) seals off the open region of the inner space (8) of the receiving container (9). At least a partial section of an inner surface (27) of the cap (3) can be sealingly attached to the receiving container (9) at the open first end region (4) of the cap casing (10), which first end region faces the receiving container (9), opposite the open end face (11) of the receiving container (9), and the first sealing device (7) is located at a region of the outer surface (31) of the cap casing (10). The invention also relates to a method for producing the closure device (2).

Description

RECEPTION DEVICE WITH SEPTUM AND METHOD OF MANUFACTURE THEREOF

The invention relates to a receiving device for blood, body fluids, tissue parts or tissue cultures or organic material, which receiving device is formed from a closure device, comprising a cap and a first sealing device, and from a receiving container. The invention also relates to a method for producing a closure device for a receptacle of a receptacle for blood, body fluids, tissue parts or tissue cultures or organic material.

A receiving device from the same applicant is known, for example, from EP 0 915 737 B1, in which a conical sealing element is inserted in the bottom area of the receiving container and held pretensioned by means of a cap engaging in the outer circumference of the receiving container in order to achieve tightness.

Another recording device from the same applicant is known from EP 0445 707 B1 and US Pat protruding extensions and the sealing plug superior approach is formed. In addition, an additional retaining ring is provided between the flange-shaped extension of the sealing stopper and the extension of the cap, which is arranged at a distance from the receptacle.

Furthermore, a sealing device is known from EP 2 277 625 A1, wherein the sealing device is held in the cap via a coupling device, the coupling device being arranged at a distance from one another in the direction of a longitudinal axis and at least in regions over an inner circumference of the cap, starting from a cap jacket in Is formed in the direction of the longitudinal axis projecting extensions, so as to achieve tightness.

The present invention is based on the object of creating a receptacle for blood, body fluids, tissue parts or tissue cultures or organic material, in which the tightness of the receptacle can be maintained, in particular over a longer storage period. Furthermore, the present invention is based on the object of providing a method for producing a closure device, comprising the cap and the first sealing device, for a receiving container to form the receiving device, the tightness of the receiving device being improved in a particular way by the manufacturing method and at the same time the Production of the closure device is energetically optimized and thus economically possible.

These objects are solved by a device and a method according to the claims.

The invention relates to a receiving device for blood, body fluids, tissue parts or tissue cultures or organic material, the receiving device consisting of a closure device comprising a cap made of a first plastic material with a cap jacket, a first end area and a second end area, which the first end area in opposite direction of a central axis, as well as a first seal arranged on the cap s device made of a pierceable, highly elastic and self-sealing material, and the receiving device also consists of an approximately cylindrical receiving container enclosing an interior space, wherein a cap jacket of the cap with its open and the receiving container facing the first end region overlaps or surrounds an open end face of the receiving container. Furthermore, at least a partial section of an inner surface of the cap on the open first end region of the cap shell facing the receptacle can be fastened to the receptacle in a sealing manner, in particular gas-tight and liquid-tight, with respect to the open end face of the receptacle, and the first sealing device is on a region of the outer surface of the cap shell or the cap arranged.

The first sealing device is designed to seal the interior of the receptacle from the outside of the receptacle. The sealing device is arranged on at least part of an outer surface of the cap jacket or on at least part of the outer skin of the cap in the radially inner area of the cap . The outer surface of the cap is to be understood as meaning the entire outer surface of the cap. “Outside” is to be understood as meaning those parts of the surface that do not face the receiving container. In this sense, the cap jacket includes both the radially outer part of the cap and the radially inner part of the Cap, which radially inner part of the cap can protrude into the receptacle. In particular, the cap can enclose an approximately cylindrical recess or a receiving area for receiving the sealing device in the second end area in the radially inner area of the cap. In the same way, the cap is designed to form a seal with the receiving container in relation to the outer environment of the receiving device due to the design according to the invention. The cap can advantageously be shaped in such a way that an inner skin of the cap encompasses the open end face of the receptacle both on the inner surface and on the outside surface of the receptacle at the open end end of the receptacle or engages over the open end face of the receptacle. In contrast to the previously explained outer skin of the cap, the inner skin of the cap is to be understood as that part of the surface of the cap which is arranged on the inside of the cap. Likewise, the inner surface of the cap is used interchangeably with the inner skin of the cap.

The first seal s device can be pierced by means of a medical needle or a cannula or a sampling needle for taking a sample and is designed to be self-sealing after the needle has been removed. The first seal s device can have a cylindrical, radially outer peripheral surface, which peripheral surface can be formed in a receiving area of the cap provided for this purpose or in a partial area of the outer surface of the cap with a positive and/or non-positive fit with the cap. Thus, the cap can be sealed with respect to the first sealing device or the closure device can thereby be formed in a sealing manner.

The advantage here is that the first seal s device is specially designed for puncturing. This results in a saving of material for the first sealing device, which is economically advantageous. The cap may be further sealed to the receptacle with a second sealing device. This results in a separation of the sealing function and the pierceability of the closure device. Furthermore, it is advantageous that the amount of plastic for the first sealing device can be reduced, since the sealing device does not have to be arranged over the full circumference of the interior of the receiving container on the open end face of the receiving container. At the same time, the first seal of the device can have a sufficient longitudinal extent in the direction of the central axis in order to continue to ensure the functionality of the independent resealability and the gas barrier of the receiving device. This is followed by an economical advantageous manufacturability of the closure device and the entire receiving device.

Furthermore, the security of the receiving device against leaks or contamination of the interior of the receiving container is increased since the seal between the receiving container and the cap does not have to be pierced when taking a sample.

Furthermore, it can be expedient if the first sealing device is separated from the interior of the receptacle by a wall of the cap in a gas-tight and liquid-tight manner. The wall can be formed in the second end area of the cap adjoining the first sealing device. The wall thus forms a further sealing element with the first sealing device. Furthermore, a stop or a delimitation surface is thereby formed in the direction of the central axis for the introduction or molding of the first sealing device. It can thus be achieved that a dimensionally stable and at the same time sealing connection is formed between the cap and the first seal s device over the entire interior area of the closure device. Furthermore, an improved sealing effect of the closure device can be brought about in the area of the second end area of the cap in relation to the external environment of the receiving device and in relation to the interior of the receiving container. If the first sealing device is formed directly adhering to the cap or if there is a material connection between the cap and the first sealing device, the sealing effect of the sealing element is again improved.

Furthermore, provision can be made for the cap to be in the form of a hot-formed compression-molded part. This can create the possibility that the outer predominantly cylindrical peripheral surface of the first seal s device or a partial area thereof can be molded particularly effectively to the inner surface of the cap jacket, so that a material connection is formed. It is conceivable, for example, that the material of the cap as a hot-formed compression-molded part when the first sealing device is molded on, due to the compression-molding of the cap that took place shortly beforehand, is in a favorable state for at least partial connection or connection at a chemical or molecular level with the first sealing device is. This results in a form fit that is particularly strong in connection with a special sealing effect of the connection, or the connection can be assumed to be technically tight. In addition, it can be provided that at least a partial area of an outer cylindrical peripheral surface of the first seal is embedded in the device under elastic radial prestressing and shaped directly against an outer surface of the cap jacket. This measure, which appears simple, means that the outer cylindrical peripheral surface of the first seal s device is embedded in the cap in a particularly stable position. This enables a permanent and, above all, particularly tight closure by means of the closure device for the receptacle of the receptacle. The fitting of the outer cylindrical peripheral surface of the first sealing device to the inner surface of the cap jacket during the manufacture of the assembly comprising the cap and the first sealing device also prevents or reduces the likelihood of contamination during assembly of this assembly occur, which can subsequently cause contamination of a sample in the recording device.

Also advantageous is an embodiment according to which it can be provided that the cap has a receiving area which is designed approximately or predominantly in the shape of a cylinder jacket and which protrudes into the interior of the receiving container. The receiving area has a boundary wall, the radially inner surface of the boundary wall directly adjoining the peripheral surface of the first sealing device, and at least a portion of the radially outer surface of the boundary wall directly adjoining the receiving container. In this sense, the boundary wall is a partial section of the cap which protrudes into the interior of the receptacle and in the interior of which the first sealing device is formed. Consequently, the cap overlaps or surrounds the entire open end area of the receptacle, which improves the seal between the closure device and the receptacle. The first seal s device introduced into the receiving area can further improve this sealing effect with appropriate material properties if a force in the radially outward direction is induced or introduced by the first seal s device by appropriate dimensioning and introduction or molding of the first seal device. In this context, it can also be advantageous for the radially outer surface of the boundary wall to have at least one circumferential bead or at least one sealing bead. According to a further development, it is possible for the first seal s device to be arranged in the receiving area, which is designed approximately in the shape of a cylinder jacket, and is separated from the interior of the receiving container by a wall in the area of a cylinder base of the receiving area. The wall can be arranged directly adjacent to the first sealing device in the second end region of the cap. The wall thus forms a further sealing element in cooperation with the first seal s device. Furthermore, a stop or a delimiting surface is thereby formed in the direction of the central axis for the introduction or molding of the first seal s device. It can thus be achieved that a dimensionally stable and at the same time sealing connection is created between the cap and the first sealing device over the entire interior area. Furthermore, improved sealing of the closure device in the area of the second end area of the cap relative to the outside environment of the receiving device and relative to the interior of the receiving container can be effected. If the first seal s device is formed directly adhering to the cap, the sealing effect of the sealing element is again improved.

Furthermore, it can be expedient if the inner surface of the cap or the inner skin of the cap is at least partially designed as a sealing surface. It is conceivable that the sealing surface is formed by means of a coating. It can also be advantageous if the inner surface of the cap is designed in such a way that it has a particularly hard surface in the partial areas of the sealing surfaces compared to the correspondingly softer surface of the receptacle lying thereon, or vice versa. In any case, it is advantageous that the sealing of the cap with respect to the receiving container is improved by means of the sealing surface.

In addition, it can be provided that the cap has no sprue or that the cap is designed without sprues. This can ensure that a sprue as an undesired geometric deviation from the intended shape of the contact surfaces of the cap in relation to other components of the receiving device is avoided. Thus, the quality of the seal between the cap and the sealing device and further between the cap and the receptacle, and subsequently between the first seal s device and the receptacle is decisively improved. Furthermore, it can be provided that the cap is produced by means of an intermittent continuous compression molding process. In this way, the possibility can be created that the outer predominantly cylindrical peripheral surface of the first seal s device or at least a partial area thereof is formed so that it fits particularly effectively against the inner surface of the cap jacket. It is conceivable, for example, that the material of the cap as a hot-formed compression molding is in a favorable state for at least partial attachment or connection to the first sealing device when the first sealing device is molded on due to the compression molding of the cap that took place shortly before. This brings about a positive connection or material connection with an advantageous sealing effect of the connection. In an alternative method, which does not work intermittently and continuously, this can only be implemented with increased technical and energy expenditure.

According to a particular embodiment, it is possible for the first sealing device to be manufactured by means of an intermittent continuous compression molding process. It is advantageous here that a direct material bond or bond is formed on the common connecting surface between the cap and the first sealing device. Not only does the material of the first seal s device penetrate into minute irregularities of the surface of the portions of the cap contacting the first seal s device during compression molding of the first seal s device, but the plasticized material from which the first seal s device is formed causes during compression molding a direct chemical or molecular connection of the contacting partial areas of the surface of the cap with at least one partial area of the outer predominantly cylindrical peripheral surface of the first sealing device. The closure device, at least comprising the cap and the first sealing device, can thus be produced integrally or in one piece.

According to an advantageous development, it can be provided that the cap is produced by means of an injection molding process. The advantage here is the economic aspect that the injection molding technology in the production of medical products such as the receiving device according to the invention is technically mature.

In particular, it can be advantageous if the first sealing device is made of rubber or, in particular, of bromobutyl rubber or TPE. These materials or in particular the material bromobutyl rubber has a particularly advantageous effect on the molding properties or on the molding properties in relation to the cap in order to ensure the sealing effect between the two components. Furthermore, this material can be pierced, is highly elastic and can be automatically resealed and, if the material is thick enough, it is gas-tight.

Furthermore, it can be provided that the first seal s device is made of TPE. It can also be advantageous if the first seal s device is made of materials with material properties similar to TPE, such as silicone or polyurethane. These materials are characterized by advantageous behavior when molding as when molding, and these materials are advantageous in terms of sealing against the environment of the first seal s device and in terms of resealability of the first seal s device after piercing or piercing the first sealing device during sampling with a medical needle.

In addition, it can be provided that the cap and the first sealing device are designed as a hot-formed two-component compression molding or two-component injection molded part. Thus, the cap and the first sealing device are formed integrally or in one piece or there is a material bond between the two. The common connecting surfaces between the cap and the first sealing device are connected chemically or at the molecular level and are technically tight in accordance with the material properties of the cap or the first sealing device. At the same time, the technical requirements for the cap, such as its impact strength or its resistance to external influences, and for the first seal's device, such as its ability to be pierced and its ability to be resealed independently, continue to be guaranteed.

Also advantageous is an embodiment according to which it can be provided that the first sealing device is embedded under elastic radial prestress in the compression molding part as a second component and is molded directly adhering to the inner, approximately cylindrical surface of the molding or to the inner surface of the cap jacket. For example, it is conceivable that in an intermittent continuous manufacturing process, in a first step, the cap is formed by means of a first and a second mold half. is formed. Subsequently, the cap remains in the first mold half and the second mold half is removed from the engagement area. A further plasticized material is then introduced into the cap positioned in the first mold half, whereupon a further mold half of the further plasticized material is used to directly bond the first sealing device to the inner surface of the cap skirt.

According to a development, it is possible for the cap to be formed at least partially from a first plastic material from a group comprising PE, HD-PE, PET, or PP. The materials chosen for the cap result in advantageous sealing properties of the receiving device. Since the first sealing device in particular and possibly the receptacle can be made of softer materials than the cap in terms of technical properties such as rigidity, low-temperature impact strength or brittle fracture behavior, the pairing of materials results in better sealing of the individual parts of the receptacle against one another.

Furthermore, it can be expedient if a thread arrangement with interacting thread turns is provided between the cap and the receptacle. By screwing the cap onto the receptacle, a resultant force can be built up via the threads, emanating from the receptacle in a direction along the central axis toward the cap. The open end face of the receptacle is thus pressed against a corresponding surface of the cap, resulting in a further sealing surface for sealing the receptacle relative to the cap. Furthermore, the cap can be sealed with respect to the first sealing device, as explained above, so that overall an improved mutual sealing effect of the individual parts of the receiving device results. This improves the sealing of the receiving device, viewed as an overall system, in relation to the external environment of the receiving device. This can be particularly advantageous if the receiving device or the interior of the receiving container has a lower internal pressure than the external environment.

In addition, it can be provided that the thread arrangement, viewed over its longitudinal course, is formed by a plurality of thread segments arranged one behind the other in the circumferential direction and spaced apart from one another. As a result, the demolding or the demolding of the Cap improved when manufactured by compression molding. The molding tool or the second mold half can be easily removed from the molded cap in a direction along the central axis after the molding of the cap. With regard to the sealing of the cap, in particular in relation to the first sealing device, this results in the synergetic advantage that simplified demoulding can be implemented significantly faster than, for example, turning out the second mold half. Further process steps, such as the direct shaping of the first sealing device, can thus be added without unnecessary delay, which entails the advantages described above.

Furthermore, it can be provided that the interior of the receiving container is evacuated, or that the interior of the receiving device, which is at least partially formed by the interior of the receiving container, is evacuated. Since the first seal s device is embedded directly in the molded part under elastic radial pretension, the evacuated interior of the receptacle results in an interactive advantage with regard to the sealing of the receptacle from the external environment. Due to the overpressure acting from the external environment in relation to the interior of the receptacle, the tightness of the closure device relative to the receptacle is increased in the region of the contact surfaces between the closure device and receptacle.

According to a special embodiment, it is possible for the wall to have a smaller wall thickness than the cylindrical side walls of the cap jacket. It can thus be achieved that a dimensionally stable and at the same time sealing connection is formed between the cap and the sealing device over the entire interior area of the closure device.

According to an advantageous development, it can be provided that the wall has a wall thickness that originates from a wall thickness range whose lower limit is 0.01 mm, in particular 0.05 mm, and whose upper limit is 0.9 mm, in particular 0.3 mm, is. There is thus a dimensionally stable and sealing connection between the cap and the first sealing device, while the first seal s device and also the wall, corresponding to their low wall thickness in the preferred range between 0.05mm and 0.3mm, can be designed to be pierceable . In particular, it can be advantageous if the wall is designed as a further sealing element in cooperation with the first sealing device. As a result, an improved sealing effect of the closure device in the area of the second end area of the cap can be brought about in relation to the outside environment of the receiving device and in relation to the interior of the receiving container. If, in addition, the first seal s device is molded directly onto the cap and thus adheres to the wall, the sealing effect of the sealing element is improved in turn.

Furthermore, it can be provided that the wall can be pierced. This makes it possible to take a sample, for example using a medical needle or a cannula or sampling needle, while at the same time the tightness of the receptacle is improved when the receptacle is unused or the wall has not yet been pierced, particularly with regard to long storage times.

In addition, it can be provided that the wall has a circular recess or punched-out area. The possibility can thus be created that, when a medical needle is pierced through the first sealing device, a reduced resistance to puncturing is achieved compared to an embodiment with a wall. As a result, the shearing force in the piercing direction in the connecting surfaces between the cap and the first seal of the device is subsequently reduced, which is equivalent to protecting this connecting surface. This protects the seal between the cap and the first sealing device and improves the sealing effect when using the receiving device.

Also advantageous is an embodiment according to which it can be provided that the wall is formed from a second plastic material. With the appropriate selection of the properties of the second plastic material, the sealing properties of the closure device can thus be improved.

According to a further development, it is possible for the cap to have a receiving device in the second end region for receiving a marking ring. It is advantageous here that an additional identification option for the receiving device is created by the marking ring. The marking can contain the seal quality, for example. An indicator for the expiration date can also be created by means of the marking ring. For example, the marking ring with a correspondingly long storage or yellowing from exposure to other environmental influences, representing end of life of the containment device. At the same time, the cap and the first seal's device can continue to be designed with unchanged sealing properties and unaffected by the material properties of the marking ring.

Furthermore, it can be expedient if the marking ring can be snapped into place in the receiving device. It is advantageous here, for example, that the marking ring is locked into the receiving device or positioned in the receiving device even after a sample has been taken or after a sample has been introduced into the receiving device. Thus, in the same way as described above, an indicator for the shelf life or the expiration or lifespan of a sample can be created.

In addition, it can be provided that the cap is formed in a form-fitting manner on the receptacle. In the manufacturing process, for example, a receiving container can be introduced into the not yet fully hardened or hardened cap. In this way, the cap can be molded onto the receiving container in a form-fitting manner. The advantage here is that the sealing effect between the receptacle and the closure device or the cap is improved. Contamination of the interior of the receiving container is also avoided or reduced, since a separate process step for assembling or joining after the production of the individual parts of the receiving device is eliminated.

Furthermore, it can be provided that the cap is formed non-positively on a thread arrangement of the receptacle. The advantage here is that the sealing effect between the receptacle and the closure device or the cap is improved. Contamination of the interior of the receiving container is also avoided or reduced, since a separate process step for assembling or joining after the production of the individual parts of the receiving device is eliminated. Furthermore, the receiving container can be separated from the closure device largely non-destructively by loosening the threaded arrangement by means of the threaded arrangement, which enables a subsequent removal of a sample from the interior of the receiving container without contamination of the sample. In addition, it can be provided that the thread arrangement, viewed over its longitudinal course, is formed by a plurality of thread segments arranged one behind the other in the circumferential direction and spaced apart from one another. This ensures that the cap can be removed from the mold when it is produced by means of compression molding. The compression molding tool or second mold half can be removed from the formed cap in a direction along the central axis after the cap has been formed with a purely linear movement. With regard to the sealing of the cap, in particular in relation to the first sealing device, this results in the synergetic advantage that a linearly guided demoulding can be implemented significantly faster than, for example, turning out the second mold half. In this way, further process steps, such as the direct shaping of the first seal, can be added to the device without unnecessary delay, which brings with it the advantages described above.

In addition, it can be provided that the closure device has a second sealing device in the area of the open front end of the receptacle. Provision can be made for the second sealing device to be positioned and/or formed or held in a recess provided for this in the cap in such a way that at least part of the second sealing device protrudes from the imaginary continuous inner skin of the cap. It is also conceivable that the second sealing device is positioned in the area opposite the open front end of the receptacle. When the receptacle is engaged with the cap, in particular by means of the thread arrangement, the open front end of the receptacle is pressed against the second sealing device and the second sealing device is pressed against the cap. This results in an advantageous sealing of the cap in relation to the receiving container.

The invention further relates to a method for producing a closure device, comprising a cap and a first sealing device, for a receptacle of a receptacle for blood, body fluids, tissue parts or tissue cultures or organic material, comprising at least the following steps:

- Introducing a first sealing material for forming the first seal s device, made of a pierceable, highly elastic and self-sealing material, into a first mold half of a first mold of a plastic compression or injection molding machine in an approximately cylindrical area with its central axis lying on the central axis of a mold cavity of the first mold half and which cylindrical portion has a maximum diameter (Dl), at the point where the cylindrical portion has the greatest diameter along its central axis, which is between 10% and 60% of the maximum diameter (D2) of the cap and has a height dimension (H) along the central axis of 2 mm to 20 mm;

- Introducing a first plastic material to form the cap comprising a cap skirt, into the first mold half, the first sealing device being positively and/or non-positively connected to the cap skirt, and

- Demoulding of the closure device.

When the closure device is produced by means of an injection molding machine, for example, the first mold, which comprises the first mold half and a second mold half, can be in the closed state. A first mold element can be arranged in the first mold half and/or in the second mold half, which first mold element is designed to delimit at least the first sealing element or at least a peripheral surface of the first sealing element within the first mold. The first sealing element is formed from the first sealing material within the first mold element by injection molding. If the first sealing element is dimensionally stable, the first mold element can be removed from the cavity in the first mold that gives the closure device its shape. By introducing the first plastic material, the cap is formed in the first mold half or is formed onto the first sealing device. It is advantageous that this method creates a material connection between the first sealing device and the cap.

Furthermore, it can be advantageous if the first sealing device is coated with the first plastic material on a side opposite a mold base of the first mold half. As a result, a wall is formed which, in cooperation with the first sealing device, acts as an additional sealing element.

In addition, it can be provided that the first sealing material is selected from a group consisting of rubber, bromobutyl rubber and TPE.

Also advantageous is an embodiment according to which it can be provided that the first plastic material is selected from a group consisting of PE, HD-PE, PET or PP. Furthermore, it can be expedient if the first seal s device is positioned in the first mold in the hardened state before the introduction of the first plastic material. In this case, the cap is molded onto the first sealing device when it is being molded, and a material bond is thus formed between the cap and the first sealing device.

Furthermore, it can be expedient if the closure device is produced by means of an injection molding process, the process additionally comprising the following steps:

- Forming the cap from the first plastic material by means of the first mold half and the second mold half combined with the first mold half in the injection molding process;

- Opening an approximately cylindrical receiving area for receiving the first sealing device by retracting a partial area of the first mold half or the second mold half from the first mold;

- Molding the sealing device from the first sealing material in the cylindrical receiving area of the first or the second mold half.

When the closure device is produced by means of an injection molding machine, for example, the first mold, which comprises the first mold half and a second mold half, can be in the closed state. A second mold element can be arranged in the first mold half and/or in the second mold half, with the section of the second mold element which is arranged in the region of the cavity of the first mold having a geometric shape which essentially or in particular corresponds to the geometric shape of the corresponds to the first sealing device. The cap is formed from the first plastic material within the first mold by injection molding. In the first mold, the second mold element thus forms the approximately cylindrical receiving area for accommodating the first seal s device. If the cap is dimensionally stable, the second mold element can be removed from the cavity in the first mold that shapes the closure device. By introducing the first sealing material, the first seal s device is formed in the first mold half or molded to the cap. It is advantageous that this method creates a material connection between the first seal device and the cap. As an alternative to an injection molding process, it can be advantageous if the closure device is produced by means of a continuous intermittent compression molding process, the process additionally comprising the following step:

- forming the cap, using the first plastic material in the uncured state, by compression molding using a third mold half and the first mold half.

After the first plastic material has been introduced into the first mold half, the cap is formed by pressing, dipping or introducing the third mold half into the first mold half. It is advantageous here that the cap is produced without sprue and that the compression molding process is a continuous process. This avoids a discontinuous flow of material, which is advantageous in terms of economy and, with regard to a comparatively lower temperature level of the plasticized plastic material, also in terms of energy. It may be expedient if the first sealing device is positioned in the first mold half or the second mold half of the first mold before the introduction of the first plastic material for molding the cap.

According to a development, it is possible for a second sealing device to be positioned in the first mold half or the second mold half before the cap is molded. The second seal s device forms an advantageous seal between the closure device and the receptacle. By introducing the second sealing device before the cap is formed, the second sealing device can be formed onto the cap or a bond between the cap and the second sealing device can be formed.

When manufacturing the closure device by means of a continuous intermittent compression molding process, it can be expedient if the process additionally includes the following step:

- forming the sealing device using the first sealing material in the uncured state by compression molding using a fourth mold half.

It is conceivable that the cap is positioned in the first mold half. The first sealing material is introduced into the area provided for the first sealing device or into the approximately cylindrical receiving area in the first mold half. The first seal s device is then formed using the fourth mold half or molded onto the cap. This creates a material bond between the cap and the first seal s device that is technically tight.

Furthermore, it can be expedient if at least a partial area of a cap jacket of the cap is molded onto the first seal s device in the not yet hardened state of the first plastic material.

- Providing a receptacle with a predominantly cylindrical interior;

- Inserting the receiving container into a fifth mold half, with a part of the outer surface of the receiving container protruding from the fifth mold half, with the part of the receiving container protruding from the fifth mold half being the open front end of the receiving container and with a central axis of the receiving container having a central axis of the fifth mold half is aligned;

- merging the fifth mold half with the first mold half and the closure device arranged therein with the first plastic material in the not yet hardened state;

- Molding of the cap jacket of the cap on the receiving container in the not yet hardened state of the first plastic material, so that a positive and/or non-positive connection is formed.

The receiving container can be removed, for example, by means of a vacuum gripper, adhesive gripper or

Pincer grippers are positioned and held in the fifth mold half. A part of the receiving container protrudes from the fifth mold half. In particular, the part of the receiving container that is subsequently in contact with the cap or the cap jacket of the cap or with the inner skin of the cap or is formed on the inner skin in the present method can protrude from the fifth mold half. The receiving container is positioned in the fifth mold half in such a way that its open end protrudes from the fifth mold half and that the central axis of the receiving container is aligned with the central axis of the fifth mold half or with the central axis of the closure device positioned in the first mold half is aligned. The fifth mold half with the receptacle arranged therein is then brought together with the first mold half or introduced or pressed into the first mold half, the first plastic material in the first mold half not yet having hardened. The cap jacket or at least a partial area of the cap jacket of the cap is formed onto the receiving container. A positive and/or non-positive connection is thus formed between the cap and the receptacle. The advantage here is that the entire receiving device can be produced by means of continuous intermittent compression molding and the possibility of contamination is therefore minimized in comparison to assembling the individual parts by means of individual assembly steps. At the same time, an advantageous sealing effect can be achieved between the receptacle and the closure device.

For a better understanding of the invention, it is explained in more detail with reference to the following figures.

They each show in a greatly simplified, schematic representation:

1 shows a portion of a first possible embodiment of a receiving device;

2 shows a partial area of a second possible embodiment of a receiving device;

3 shows a partial area of a third possible embodiment of a receiving device.

As an introduction, it should be noted that in the differently described embodiments, the same parts are provided with the same reference numbers or the same component designations, it being possible for the disclosures contained throughout the description to be applied to the same parts with the same reference numbers or the same component designations. The position information selected in the description, such as top, bottom, side, etc., is related to the directly described and illustrated figure and these position information are to be transferred to the new position in the event of a change in position. In the following, the term "in particular" is understood to mean that it can involve a possible more specific design or more detailed specification of an object or a method step, but does not necessarily have to represent a mandatory, preferred embodiment of the same or a mandatory procedure. As used herein, the terms "comprising,""comprises,""having,""includes,""including,""includes,""containing," and any variations thereof are intended to cover non-exclusive inclusion.

1 shows a partial area of a possibly independent first embodiment of a receiving device 1 . The receiving device 1 is particularly suitable for blood, body fluids, tissue parts or tissue cultures or organic material. The receiving device 1 comprises a closure device 2 and a receiving container 9, which receiving container 9 includes a predominantly cylindrical interior 8 and has an open face 11 at one end. That second end, which is arranged opposite the first end with the open end face 11, is preferably designed to be closed with a bottom wall. In general, the bottom wall can also be referred to as just the bottom. The three-dimensional shape of the bottom wall can be arched or dome-shaped on the side facing away from the open first end. However, the bottom wall can also be formed by a cap-shaped end wall. However, it would also be possible to design the bottom wall to be almost flat as a front wall. The receiving container 9 can, for example, have the shape of an eprouvette and be made of a plastic material or glass material.

The receiving device 1 comprising the receiving container 9 and the closure device 2 can also be designed or used, for example, as an evacuated sample-taking tube, in particular as a blood sample-taking tube, in a wide variety of embodiments.

The closure device 2 comprises a first sealing device 7 and a cap 3, which cap 3 has a first end region 4 and a second end region 5, the second end region 5 being arranged opposite the first end region 4 in the direction of a central axis 6, and the first end region 4 has an open end of the cap 3. Furthermore, the cap comprises a cap jacket 10, a thread arrangement 15 and a wall 16 arranged in the second end area 5. The cap 3 is arranged in such a way that the cap shell 10 surrounds, overlaps or envelops the open end face 11 of the receptacle 9, or that the receptacle 9 is designed to engage at least partially in the cap 3 or in the cap shell 10. In this sense, the cap jacket 10 also includes the partial area of the cap 3 which protrudes into the interior of the receptacle 9 . The first sealing device 7 comprises at least one sealing surface in the area of the cylindrical peripheral surface 25. The cap 3 further comprises at least one sealing surface 12 in a partial area of the inner skin 28 of the cap or the inner surface 27 of the cap, by means of which the cap 3 seals against the receptacle 9 is arranged. The inner skin 28 or, synonymously with this, the inner surface 27 of the cap is to be understood as meaning the partial area of the surface of the cap 3 which is inside the cap. In the same way, the outer skin 30 of the cap 3 or, synonymously with this, the outer surface 31 is to be understood as meaning that partial area of the surface of the cap 3 which is on the outside of the cap. For example, in FIG. 1 the adjacent opposite surface to the peripheral surface 25 of the first seal s device 7 is to be regarded as part of the outer skin 30 . The sealing surface 12 faces the inner surface of the receptacle 9 on the one hand and closes the clear cross-section of the receptacle 9 by means of the closure device 2 on the other hand this can also be referred to as evacuated or partially evacuated.

As can be seen in FIG. 1, part of the cap 3 or of the cap jacket 10 protrudes into the open end of the receptacle 9 at the front. At least a partial area of the inner skin 28 of the cap 3 touches part of the predominantly cylindrical inner surface of the receptacle 9 and part of the predominantly cylindrical outer surface of the receptacle 9, as a result of which the cap 3 encloses the receptacle 9 at its front open end.

The cap 3 can be formed as a thermoformed compression molding or as an injection molded part. In particular, the cap 3 can be produced by means of an intermittent, continuous compression molding process, as a result of which the cap 3 has no sprue or is designed without sprue. The cap 3 thus has a high surface quality over the entire circumference without flaws, as a result of which an advantageous sealing effect can be achieved on the contact surfaces with the first sealing device 7 and with the receptacle 9 . It is conceivable that at the contact surfaces between the cap 3 and the receptacle 9 sealing elements such as a coating or elastically deformable beads are provided. Sealing surfaces 12 of the closure device are formed in the contact area between the predominantly cylindrical inner surface of the receptacle 9 and the cap 3 .

At least a portion of an outer peripheral surface 25 of the first sealing device 7 is embedded in the cap 3 under elastic radial pretension. The peripheral surface 25 is formed directly adjacent to an outer surface 13 of the cap jacket 10 or to a partial area of the outer skin 30 of the cap 3 .

The first seal s device 7, like the cap 3, can be manufactured by means of a continuous intermittent compression molding process. It is possible for the first sealing device 7 and/or the cap 3 to be joined together in a state that has not yet hardened, or for the first sealing device 7 to be formed directly in the cap 3, for example. There is also the possibility that the receiving device 1 is formed by inserting or pressing the receiving container 9 into the not yet hardened cap 3 or into a first plastic material from which the cap 3 will be formed. In this case, the cap 3 is molded onto the receiving container 9 .

In the area of the radially outer contact surface between the receptacle 9 and the cap 3, the inner skin 28 of the cap 3 can be shaped in such a way that a thread arrangement 15 is formed. The thread arrangement 15 can be designed to correspond or be complementary in shape to the outer circumference of the receptacle 9 at the front. When the thread arrangement 15 engages accordingly or when the cap 3 is screwed on or when the cap 3 is molded with the thread arrangement 15 onto the open end of the receptacle 9, the resultant force can cause a front sealing surface 29 of the receptacle 9 to press against the cap 3 or against part of the inner skin 28 of the cap 3 in a sealing manner.

The thread arrangement 15 can also be segmented, with the individual thread segments being arranged in succession or one behind the other along the course of the thread arrangement 15 on the inner surface 27 or the inner skin 28 of the cap 3 . The cap 3 can have a wall 16 in the second end region 5, which wall 16 advantageously has a smaller wall thickness than the cap jacket 10 or the rest of the cap 3. In cooperation with the first sealing device 7, the wall 16 can form a sealing element 17. Furthermore, the wall 16 can be formed with the cap 3 as a two-component molded part 14 . The wall 16 preferably has a wall thickness that comes from a wall thickness range whose lower limit is 0.01 mm, in particular 0.05 mm, and whose upper limit is 0.9 mm, in particular 0.3 mm, whereby the Wall 16 can be pierced with a medical needle, a cannula or a sampling needle when taking a sample. The first seal s device 7 arranged adjacent to the wall 16 is preferably made of an automatically reclosable plastic, in particular rubber, bromobutyl rubber or TPE (thermoplastic elastomer). 1 shows an embodiment in which the wall 16 is continuous and thus, in cooperation with the first sealing device 7 , forms a further sealing element which seals the interior 8 of the receptacle 9 from the external environment of the receptacle 1 . It is also conceivable for the wall 16 to have a punched-out area or recess in the radially inner area. In this case, too, the sealing effect with respect to the external environment is ensured by the first sealing device 7 .

Furthermore, there is the possibility that the first sealing device 7 and the cap 3 are formed as a two-component compression molding by a continuous intermittent compression molding process.

Since, as in the illustrated embodiment, the receptacle 9 is enclosed by the cap 3 or by the cap jacket 10 in the region of the inner skin 28 of the cap 3, the cap 3 and the receptacle 9 seal one another. At the same time, the interior space 8 of the receptacle 9 is always sealed off from the outside environment of the receptacle device 1 since the first sealing device 7 is arranged or formed in a sealing manner on the peripheral surface 25 . Since the first sealing device 7 is introduced or molded into the cylindrical recess of the cap 3 under elastic radial pretension, the sealing effect on the sealing surface 12 or the sealing surfaces 12 of the closure device 2 is intensified. Basically, it is conceivable that the first seal s device 7 is designed as a solid cylinder with a hollow at the end open to the outside and that this solid cylinder has a diameter D1 in the range between 10% and 60% of the maximum diameter D2 of the cap 3. The diameter Dl can be selected in cooperation with the height H of the first sealing device 7 in such a way that the first sealing device 7 ensures automatic resealing of the first sealing device 7 after a sample has been taken with a medical needle, so that the first sealing device 7 closes is gas- and liquid-tight at all times.

The arrangement shown of the first sealing device 7 and the enclosing of the receptacle 9 by means of the cap 3 separate the seal and the piercing function of the receptacle 1 . If the closure device 2 were to seal the receiving container 9 from an external environment of the receiving device 1 exclusively with the first sealing device 7, this separation would not be guaranteed.

FIG. 2 shows a partial area of an optionally independent second embodiment of the receiving device, the same reference numerals or component designations as in the preceding FIG. 1 being used again for the same parts. In order to avoid unnecessary repetitions, reference is made to the detailed description in the preceding FIG. 1 .

The cap 3 can have a receiving device 22 for a cover 24 or a marking ring 21 in the area of the second end area 5 . The cover 24 can be arranged in such a way that an outer skin 30 of the cap 3 encloses the cover 24 continuously and without any interruptions. This is particularly the case when the cap 3 and the cover 24 are integrally formed as a two-component compression molding or as an injection molding.

In this second possible embodiment of the receiving device 1 , a second sealing device 32 is positioned between the open front end of the receiving container 9 and between the cap 3 . In cooperation with the thread arrangement 15, the second sealing device 32 is held between the cap 3 and the receptacle 9 and is elastically deformed in such a way that the cap 3 is sealed relative to the receptacle 9 in the region of the second seal s device 32, in addition to the existing and previously described seals , is formed sealing. FIG. 3 shows a partial area of a possibly independent third embodiment of the receiving device, the same reference numerals or component designations as in the previous FIGS. 1 and 2 being used again for the same parts. In order to avoid unnecessary repetitions, reference is made to the detailed description in the preceding FIGS. 1 and 2 .

As in FIG. 3 , the cover 24 can be arranged in such a way that it at least partially covers the sealing device 7 . The seal s device 7 can thus be additionally secured in its receiving area.

In this third embodiment of the receptacle device 1, the second sealing device 32 is at least partially molded into the cap 3 in the area of the open front end of the receptacle 9. FIG. The second seal s device 32 thus protrudes at least partially from the inner skin 28 of the cap 3 enveloping the cap 3 in this area, which is thought to be continuous, so that the front end of the receptacle

9 is positioned in a sealed manner against the second sealing device 32 and thus against the cap 3 by means of the thread arrangement 15 .

The exemplary embodiments show possible variants, whereby it should be noted at this point that the invention is not limited to the specifically illustrated variants of the same, but rather that various combinations of the individual variants with one another are also possible and this possibility of variation is based on the teaching on technical action through the present invention in skills of the specialist working in this technical field.

The scope of protection is determined by the claims. However, the description and drawings should be used to interpret the claims. Individual features or combinations of features from the different exemplary embodiments shown and described can represent independent inventive solutions. The task on which the independent inventive solutions are based can be found in the description.

All information on value ranges in the present description is to be understood in such a way that it includes any and all sub-ranges, e.g. the information is 1 to

10 to be understood that all sections, starting from the lower limit 1 and the upper limit 10 are also included, ie all partial ranges start with a lower limit of 1 or greater and end with an upper limit of 10 or less, eg 1 to 1.7, or 3.2 to 8.1, or 5.5 until 10.

Finally, for the sake of clarity, it should be pointed out that some elements are shown not to scale and/or enlarged and/or reduced in size for a better understanding of the structure.

list of reference numbers

26 cylinder base of the receiving container receiving device container

Closing device

27 inner surface of the cap cap

28 inner skin of the cap first end area of the cap

29 front sealing surface of the second end area of the cap receiving container

central axis

30 outer skin of the cap first seal s device

31 outer surface of the cap skirt interior

32 second sealing device receptacle

Cap jacket open front side of the receptacle

Sealing surface of the closure device inner surface of the cap skirt

Two component compression molding

thread arrangement

wall

Sealing element circular recess

tear area

tab

mark ring

recording device

recording area

cover

peripheral surface

Claims

- 27 - P atentclaims

1. Recording device (1) for blood, body fluids, tissue parts or tissue cultures or organic material, wherein the recording device (1) consists of a closure device (2) comprising a cap (3) made of a first plastic material with a cap jacket (10), a first end area (4) and a second end area (5), which is opposite the first end area (4) in the direction of a central axis (6), as well as a first sealing device (7) arranged on the cap (3) made of a pierceable, highly elastic and self-closing material, and the receiving device (1) is also formed from a receiving container (9) of approximately cylindrical design and enclosing an interior space (8), wherein a cap jacket (10) of the cap (3) with its open and the receiving container ( 9) facing the first end region (4) overlaps or surrounds an open end face (11) of the receptacle (9), characterized in that at least a partial section of an inner surface (27) of the cap (3) on the open end facing the receptacle (9). first end area (4) of the cap jacket (10) opposite the open end face (11) of the receptacle (9) can be fastened to the receptacle (9) in a sealing manner and the first sealing device (7) is attached to an area of the outer surface (31) of the cap jacket (10 ) is arranged.

2. Receptacle (1) according to claim 1, characterized in that the first seal s device (7) from the interior (8) of the receptacle (9) by a wall (16) of the cap (3) gas and liquid-tight is separated.

3. Recording device (1) according to any one of the preceding claims, characterized in that the cap (3) is designed as a hot-formed compression molding.

4. Receiving device (1) according to Claim 3, characterized in that at least a partial area of an outer cylindrical peripheral surface (25) of the first seal s device (7) is embedded under elastic radial prestress in the compression molding part and directly attached to an outer surface (31) of the cap jacket (10) is molded snugly.

5. Receiving device (1) according to one of the preceding claims, characterized in that the cap (3) has an approximately cylinder-shaped receiving area (23) which projects into the interior (8) of the receiving container (9).

6. Receiving device (1) according to claim 5, characterized in that the first seal of the device (7) is arranged in the receiving area (23) which is approximately in the shape of a cylinder jacket and is separated from the interior (8) of the receiving container (9) by a wall (16 ) is separated in the area of a cylinder base (26) of the receiving area (23).

7. Recording device (1) according to any one of the preceding claims, characterized in that the inner surface (27) of the cap (3) is formed at least in sections as a sealing surface (12).

8. receiving device (1) according to any one of the preceding claims, characterized in that the cap (3) is formed sprue-free.

9. Receptacle (1) according to any one of the preceding claims, characterized in that the cap (3) is manufactured by means of an intermittent continuous compression molding process.

10. Receiving device (1) according to any one of the preceding claims, characterized in that the first seal s device (7) is made by means of an intermittent continuous compression molding process.

11. Recording device (1) according to any one of the preceding claims, characterized in that the cap (3) is produced by injection molding.

12. Recording device (1) according to any one of the preceding claims, characterized in that the first seal s device (7) is formed from rubber or in particular from bromobutyl rubber.

13. Recording device (1) according to one of the preceding claims, characterized in that the first seal s device (7) is made of TPE.

14. Recording device (1) according to any one of the preceding claims, characterized in that the cap (3) and the first seal s device (7) are formed as a hot-formed two-component compression molding or two-component injection molded part.

15. Receiving device (1) according to claim 14, characterized in that the first seal s device (7) is embedded under elastic radial pretension in the compression molding and is formed adhering directly to the inner approximately cylindrical surface of the receiving area (23).

16. Recording device (1) according to any one of the preceding claims, characterized in that the cap (3) is formed at least partially from a first plastic material from a group comprising PE, HD-PE, PET or PP

17. Receiving device (1) according to any one of the preceding claims, characterized in that between the cap (3) and the receptacle (9) a threaded arrangement (15) is provided with interacting threads.

18. Receiving device (1) according to claim 17, characterized in that the thread arrangement (15) seen over its longitudinal extent is formed by a plurality of thread segments which are arranged one behind the other in a peripheral view and are spaced apart from one another.

19. Recording device (1) according to any one of the preceding claims, characterized in that the interior (8) of the receiving container (9) is evacuated.

20. Recording device (1) according to claim 2 or 6, characterized in that the wall (16) has a smaller wall thickness than the cylindrical side walls of the cap jacket (10).

21. Recording device (1) according to claim 20, characterized in that the wall (16) has a wall thickness which originates from a wall thickness range whose lower limit is 0.01 mm, in particular 0.05 mm, and whose upper limit is 0 .9 mm, in particular 0.3 mm.

22. Recording device (1) according to claim 20 or 21, characterized in that the wall (16) is formed in cooperation with the first sealing device (7) as a further sealing element (17).

23. Recording device (1) according to any one of claims 20 to 22, characterized in that the wall (16) can be pierced.

24. Recording device (1) according to any one of claims 20 to 23, characterized in that the wall (16) has a circular punched-out or recess.

25. Recording device (1) according to any one of claims 20 to 24, characterized in that the wall (16) is formed from a second plastic material.

26. Recording device (1) according to any one of the preceding claims, characterized in that the cap (3) for receiving a marking ring (21) in the second end region (5) has a receiving device (22).

27. Recording device (1) according to claim 26, characterized in that the marking ring (21) can be locked in the receiving device (22).

28. Receiving device (1) according to any one of the preceding claims, characterized in that the cap (3) on the receiving container (9) is formed in a form-fitting manner. - 31 -

29. Receiving device (1) according to any one of the preceding claims, characterized in that the cap (3) on a threaded arrangement (15) of the receiving container (9) is formed non-positively.

30. Receiving device (1) according to claim 29, characterized in that the thread arrangement (15) seen over its longitudinal course is formed by a plurality of thread segments which are arranged one behind the other in a circumferential view and are spaced apart from one another.

31. Receptacle (1) according to one of the preceding claims, characterized in that the closure device (2) has a second sealing device (32) in the region of the open front end of the receptacle (9).

32. A method for producing a closure device (2) comprising a cap (3) and a first sealing device (7) for a receptacle (9) of a receptacle (1) for blood, body fluids, tissue parts or tissue cultures or organic material, comprising at least the following Steps:

- Introducing a first sealing material for forming the first seal s device (7), made of a pierceable, highly elastic and self-sealing material, into a first mold half of a first mold of a plastic compression molding or injection molding machine in an approximately cylindrical area with its central axis (6) which is arranged on the central axis of a mold cavity of the first mold half and which cylindrical region has a maximum diameter (Dl) which is between 10% and 60% of the maximum diameter (D2) of the cap (3) and along the central axis a height extension (H) of 2 mm to 20 mm;

- providing a second mold half,

- Introducing a first plastic material into the first mold to form the cap (3) comprising a cap jacket (10), the first seal s device (7) being positively and/or non-positively connected to the cap jacket (10), and

- Demoulding of the closure device.

33. The method according to claim 32, characterized in that the first sealing device (7) on a mold base of the first mold half opposite side - 32 - is covered by the introduction of the first plastic material with the first plastic material.

34. The method according to any one of claims 32 or 33, characterized in that the first sealing material selected from a group comprising rubber, bromobutyl rubber and TPE is formed.

35. The method according to any one of claims 32 to 34, characterized in that the first plastic material selected from a group comprising PE, HD-PE, PET or PP is formed.

36. The method according to any one of claims 32 or 35, characterized in that the first sealing device (7) is positioned in the first mold in the hardened state before the introduction of the first plastic material.

37. The method according to any one of claims 32 to 35, additionally comprising the following steps

- Forming the cap (3) from the first plastic material by means of the first mold half and the second mold half joined together with the first mold half in the injection molding process;

- Opening an approximately cylindrical receiving area (23) for receiving the seal s device (7) by retracting a portion of the first mold half or the second mold half from the first mold;

- Molding the sealing device (7) from the first sealing material in the cylindrical receiving area (23) of the first or the second mold half.

38. The method according to any one of claims 32 to 36, additionally comprising the following steps.

- molding the cap (3), using the first plastic material in the uncured state, by compression molding using a third mold half and the first mold half. - 33 -

39. The method according to claim 37 or 38, characterized in that before the molding of the cap (3) a second sealing device (32) is positioned in the first mold half or the second mold half.

40. The method according to any one of claims 32 to 35 or 38 or 39, additionally comprising the following steps:

- Forming the sealing device (7) using the first sealing material in the uncured state by compression molding using a fourth mold half.

41. The method according to any one of claims 38 to 40, characterized in that at least a portion of a cap jacket (10) of the cap (3) is molded onto the first sealing device (7) in the not yet hardened state of the first plastic material.

42. The method according to any one of claims 37 to 41, additionally comprising the following steps:

- Providing a receptacle (9) with a predominantly cylindrical interior (8);

- introducing the receptacle (9) into a fifth mold half, with a part of the outer surface of the receptacle (9) protruding from the fifth mold half;

- merging the fifth mold half with the first mold half and the closure device (2) arranged therein with the first plastic material in the not yet hardened state;

- Molding of the cap jacket (10) of the cap (3) on the receptacle (9) in the not yet hardened state of the first plastic material, so that a positive and/or non-positive connection is formed.