WO2024023229A1

WO2024023229A1 - Sample-receiving device

Info

Publication number: WO2024023229A1
Application number: PCT/EP2023/070865
Authority: WO
Inventors: Aitor EZKERRA FERNÁNDEZ; Daniel Hammer; Friedemann Pahner
Original assignee: Anvajo GmbH
Priority date: 2022-07-28
Filing date: 2023-07-27
Publication date: 2024-02-01
Also published as: DE102022207797A1

Abstract

The present invention relates to a sample-receiving device having a set-down means (1) and a receiver (2). The receiver (2) has a cavity (3) which is open on one side and is closed by a cover (4) such that the cavity (3) is sealed in relation to the surroundings by means of the cover (4), and the set-down means (1) has a basic body (8) with a sample container (5) and with an outlet opening (6), and has an opening element (7). The opening element (7) is configured in such a manner that, by pressing of the opening element (7) onto the cover (4), the cover (4) can be penetrated by the opening element (7), and the set-down means (1) can be set down on and fastened to the receiver (2) in such a way that the sample container (5) with the outlet opening (6) and the opening element (7) are arranged in the cavity (3), wherein the sample container (5) and the opening element (7) are arranged facing away from the basic body (8) when the set-down means is set down on the receiver (2).

Description

Sample receiving device

The present invention relates to a sample receiving device, in particular for sample analysis in the medical, pharmaceutical or biological field.

For a sample analysis, it is often necessary to subject certain quantities of a liquid sample to various analysis steps. In addition to taking the intended amount of sample, it is also important not to contaminate the sample or to contain any substance or material required for analysis

Substrate, i.e. a reagent, to be brought into contact. Solutions for this are already known from the prior art. For example, in the document DE 10 2019 204 633 A1 a device for receiving and handling a liquid sample is known, but its use can be complex, since e.g. B. a second container may be necessary to hold the device containing the sample. The present invention is therefore based on the object of proposing a sample receiving device which avoids these disadvantages, i.e. which is constructed in a mechanically stable manner and is easy to use.

This object is achieved according to the invention by a device according to claim 1. Advantageous refinements and developments are described in the dependent claims.

The sample receiving device has an attachment as the first part and a receiver as the second part. The sensor is designed with a cavity that is open on one side, the cavity being closed or lockable with a cover. The cover seals the cavity from the environment. The attachment has a base body and an opening element, the base body being provided with a sample container with an outlet opening. The opening element is designed in such a way that by pressing the opening element onto the cover, the cover can be penetrated with the opening element or through the opening element. The attachment can be placed and fastened on the receiver in such a way that the sample container with its outlet opening and the opening element are arranged in the cavity. When placed on the sensor, the sample container and the opening element are arranged facing away from the base body and pointing in the same direction.

A sample to be analyzed can be picked up and stored in the sample container. By pressing the opening element, ie exerting a force through the opening element on the cover and penetrating the cover due to the pressure or force exerted, the cover can be destroyed and access to the cavity of the receiver can thus be established. Since the transducer is open on one side and after placing or fastening the attachment inserted into the cavity, the sample is protected from all sides by the transducer or the base body, which is typically designed to be closed, on the one hand the sample can be held securely in this configuration and transported, but on the other hand, the sample can also be caused to undergo a chemical reaction with this substance using a substance already contained in the receiver. Since in this state both the opening element, the can also be referred to as an opener, as well as the sample container being arranged facing away from the base body and typically pointing in the same direction (which is to be understood in particular that the opening element and the sample container are on the same side of the base body), not only A clearly defined movement for insertion is defined, in which the two elements are moved in the same direction and which is easy to carry out, but also creates a mechanically stable connection and a compact structure.

It can be provided that the sample holder is designed in one piece with the opening element. This connection, also known as an integral design, in which the two elements are cohesively connected to one another, creates a particularly simple structure.

Alternatively, it can also be provided that the opening element and the sample holder are designed in two parts, with the sample holder typically being able to be inserted or received into a recess in the opening element. This multi-part design results in greater flexibility; for example, unlike a one-piece structure, different materials can now be used for the opening element and the sample holder. In particular, the opening element and the sample container can be connected to one another by means of a positive or non-positive or frictional push-through connection.

The sample container and the opening element can be arranged, arranged or aligned concentrically and/or parallel to one another along the longitudinal axis of the attachment. This results in a particularly simple structure in which the direction of the force for penetrating the cover is clearly defined by the arrangement along the longitudinal axis, and the force should also be applied along this longitudinal axis.

However, it can also be provided that an additional container, in addition to the sample container, is arranged, can be arranged or aligned at right angles to the opening element in order to accommodate sample parts that may not have been picked up by the sample container. Particularly when using the opening element during an opening process, problems can occur. Quantities that would otherwise be moved into unintended positions due to the forces acting and thereby possibly become dirty must be stored safely in the additional container. This additional container is typically connected to the sample container and is designed to be tunnel-shaped or channel-shaped. The term “rectangular” is intended to mean in particular that a longitudinal axis of the additional container forms an angle of between 85° and 95°, preferably between 87° and 93°, particularly preferably exactly 90°, to a longitudinal axis of the sample container. The additional container can be connected to the sample container, ie form a continuous cavity.

The sample to be collected is typically a liquid sample, i.e. H. The sample container is usually designed to hold liquid samples. The sample itself is typically present as a sample quantity in the microliter range, i.e. H. The sample container is designed to hold and hold sample quantities in the range of 0.5 pl to 100 pl. The claimed device can therefore be viewed as a mass-produced or disposable item for the reproducible recording of samples, with which the sample can be made accessible to a variety of different analysis steps, such as mixing with a substance.

The cover itself is preferably designed as a sealing plate or sealing film. Because the transducer is designed as a body open on one side with an internal cavity, the transducer can not only accommodate the transducer, but also substances or substances desired for analysis in its cavity before the transducer is introduced, that is, with the cover intact contain. The hollow space, which can also be referred to as a cavity, is typically designed as a reservoir containing a reagent. By providing the reagent or another substance in a sealed reservoir, contamination of the reagent as well as contamination of the environment can be avoided. Particularly dangerous substances, e.g. B. biohazardous substances or carcinogenic substances can therefore be transported and handled safely and without uncontrolled contact with the environment. The cavity as a reservoir can also be filled and emptied at different locations. This means that all relevant vant substances are stored and mixed (i.e. sample and reagents), reducing size, complexity and cost. The faster mixing possible due to the reduced complexity also reduces sample loss through evaporation.

The cavity can be filled with a solid, liquid or gaseous substance, in particular a fluid or several fluids such as. B. a flowable liquid, a flowable or free-flowing solid, for example a powder, granules or agglomerate, or mixtures of these can be filled or filled. However, it can also hold a viscous substance such as a gel or a paste or a solid substance that can be flushed out of the cavity using the sample or another liquid.

The opening element may have a blunt end or a beveled end for piercing the cover. A blunt end is to be understood here in particular as an end with an end surface whose surface normal is directed in the direction of or parallel to the longitudinal axis of the opener, while in the case of a beveled end the surface normal is tilted by a fixed angle with respect to this longitudinal axis. Typically, the opening element has a beveled end facing away from the base body, which is preferably angled at an angle between 0.1° and 89°, particularly preferably at 45° to 60°, in particular at exactly 60° (i.e. the surface normal of the end also includes this angle on the longitudinal axis).

The opening element can also have a tip, a pricker, a punch and/or a cutting edge in order to be able to cut through the cover more easily. Preferably, at least one tip, a piercer or a piercing mandrel is arranged at the point of the opening element that first touches the cover when the opening element is pressed. The cutting edge is preferably arranged at the edge of the surface of the opening element or the end of the opening element. The cutting edge can in particular be designed with a one-sided or two-sided, flat, spherical, hollow or concave cutting geometry. It can also be provided that the cutting edge has cutting teeth or a microbevel, which enables a particularly clean cut. The opening element can be shaped to complement an opening in the receiver that is closed by the cover, ie the opening element can in particular be shaped to fit or precisely fit this opening.

The sample container can be designed as a hollow body, in particular as a capillary tube, which is designed to hold a defined amount of sample by means of capillary forces. The sample container can also be designed as a pipette, as a sponge or as a dropper.

For easier handling, it can be provided that the attachment has a holding device on which the attachment can be held or gripped. The holding device is generally arranged on a side of the base body facing away from the sample container and the opening element. In addition, the sample container can also have the additional container as a cavity, which is formed in the base body and is designed to accommodate larger quantities of the sample if necessary. In particular, this cavity is designed to accommodate the sample if the sample should leave the sample container while the cover is being opened. Preferably, a distance from one of this cavity to an end of the sample container facing the base body is between 0.01 mm and 10 mm, particularly preferably 1 mm, in order to ensure a compact yet mechanically stable structure.

To attach the attachment to the receiver, a fastening and release device can be provided on one or both of the elements mentioned. The attachment can thereby be attached to the receiver in such a way that a relative movement of both components to one another is blocked and is only released after the triggering device has been actuated. The fastening and release device can be designed, for example, as a latching device with a releasable click or snap mechanism or as a screw connection with a locking mechanism such as a pin, a tenon, a split pin or a lever, which only allows the relative movement of the two components to one another after this Removing or pressing releases. The triggering device can typically be operated purely manually. The attachment and the receiver as well as the cover typically consist of materials that enable long-term storage of the sample or other substances, ie that are chemically or thermally resistant and, if necessary, protect the sample against environmental influences such as UV radiation, moisture or oxygen. The components mentioned can be made of plastics, e.g. B. from thermoplastics such as polypropylene, polyethylene, polyethylene terephthalate, polystyrene, cycloolefin polymers or copolymers, acrylonitrile butadiene styrene, polyether ether ketone, polycarbonate, polyamides, in particular nylon, polyoxymethylene or polyacrylic, or thermoset plastics such as epoxy, polyurethane or phenolic resins. The receiver and the attachment are preferably manufactured by injection molding processes, but can also be manufactured by additive manufacturing techniques such as 3D printing or sintering, lamination, extrusion, gluing, milling, machining or ablation.

The cover typically consists of a material that is impermeable to water or air, in particular a metal, for example aluminum, or a non-elastic plastic, i.e. H. a plastic with a modulus of elasticity greater than 0.1 GPa at 20 °C. The thickness of the cover is typically between 5 pm and 200 pm, preferably between 20 pm and 100 pm. The cover can be glued, laminated or welded, for example, to the edges of the cavity for sealing purposes.

The sensor can, at least on the side facing away from the cover, be transparent to electromagnetic radiation in the visible wavelength range, i.e. H. in the wavelength range between 380 nm and 750 nm, to be able to carry out an optical analysis of samples introduced into the cavity or reagents that react with the sample. “Transparency” is intended to mean in particular that no more than 20 percent, preferably no more than 10 percent, of the intensity of the incident electromagnetic radiation is absorbed or reflected by the sensor.

In a method for picking up and handling the sample with the device described, the sample is picked up into the sample container and the attachment is placed on the receiver in such a way that by pressing cken of the opening element on the cover, the cover is penetrated and the attachment is placed on the holder and fastened in such a way that the sample container with the outlet opening and the opening element are arranged in the cavity

The method described can in particular be carried out with the device described, that is, the device described is set up to carry out the method described.

Exemplary embodiments of the invention are shown in the drawings and are explained below with reference to Figures 1 to 15.

Show it:

Fig. 1 is a schematic, perspective view of an example of a pickup and a mounter;

2 shows a sectional view of the receiver and attachment shown in FIG. 1 in an assembled state;

3 shows, in a view corresponding to FIG. 1, a further example of an attachment and a receiver, the attachment now having a beveled end;

4 shows the components shown in FIG. 3 in the assembled state in a view corresponding to FIG. 2;

5 shows a sectional view through a mounter in which a sample container is arranged offset from a central axis;

6 shows the attachment shown in FIG. 5 in a side sectional view in the state inserted into the receiver;

7 is a view corresponding to FIG. 4, in which an additional container in addition to the sample container is arranged at right angles to an opening element; 8 shows a representation corresponding to FIG. 6 of the attachment shown in FIG. 7 in a side sectional view in the state inserted into the receiver;

9 shows a schematic partial sectional view of a multi-part embodiment of a sample receiving device;

10 shows the device shown in FIG. 9 in an assembled state;

11 is a perspective view of a sample receiving device in which the pickup and the opening element are mechanically connected to one another via a hinge-shaped connection;

12 is a perspective partial sectional view of an embodiment in which the receiver and the opening element are connected to one another, but the sample container is not yet connected;

13 shows the exemplary embodiment shown in FIG. 12 in the assembled state;

Fig. 14 is a sectional view of a sensor with several chambers and

Fig. 15 is a perspective view of transducers with multiple cavities.

Figure 1 shows a perspective view of a sample receiving device for receiving a liquid sample in the microliter range. The sample receiving device has an attachment 1 and a receiver 2, both of which are made of plastic. The attachment 1 has a central base body 8, on the top of which a gripping surface is arranged as a holding device 9 in order to be able to easily grip and move the attachment 1 with fingers or a machine. On the side of the base body 8 facing away from the holding device 9, a cylindrical, one-sided capillary vessel is arranged as a sample container 5, which is located centrally along the Longitudinal axis of the attachment 1 extends from the base body 8 and is designed to hold the sample. At the end of the sample container 5 facing away from the base body 8, an opening element 7 is arranged, which is circular in the exemplary embodiment shown in FIG. 1, but in further exemplary embodiments can also be provided with a cutting edge or a piercing mandrel.

The sensor 2 is designed as a cavity, i.e. H. has a cavity inside, which can either be unfilled if protected sample transport is desired, but is typically filled with a substance such as a reagent. In order to avoid unwanted contamination of the cavity, the sensor 2 is open on one side, the opening being closed by a cover film as a cover 4. The cover 4 is typically made of a material that is impermeable to water and air, in the exemplary embodiment shown as aluminum foil with a thickness of 25 pm.

By placing the attachment 1 on the cover 4 of the receiver 2 and exerting pressure on the cover 4, it can be penetrated by the opening element 7 so that the sample container 5 enters the cavity. Here, a purely vertical relative movement can be carried out, which is carried out essentially along the longitudinal axis of the attachment 1 and receiver 2 and nothing has to be opened manually. It is particularly advantageous here that the opening element 7 and sample container 5 are arranged on the same side of the base body 8 of the attachment 1, since a compact structure is thus realized and handling is significantly simplified. The cover 4 can thus be pierced, broken through, perforated or lifted off by simultaneously introducing the sample into the receiver 2 with just one movement.

This state, in which the attachment 1 is inserted into the receiver 2, is shown in Figure 2. In this figure, as in the following figures, identical features are given the same reference numerals. The sample container 5 is now introduced into the cavity 3 of the receiver 2 and the sample received in the sample container 5 can be released into the cavity 3 through the opening 6 of the sample container 5 or at least with one Substance contained in the cavity 3 react by being able to come into contact with the sample via an outlet opening 6 arranged on the sample container 5. The outlet opening 6 is typically located at the end of the sample container 5 facing away from the base body 8, that is, in particular in the exemplary embodiment shown in FIG. 2, it has the greatest possible distance from the base body 8. In particular, the lower part of the sensor 2, ie the part facing away from the cover 4, can be designed to be transparent to radiation in the visible wavelength range.

In further embodiments, the surface of the base body 8 facing the holding device 9 can be flush with an edge of the opening of the receiver 2, the cover 4 being attached to this edge before penetration. Alternatively, the base body 8 itself can also remain outside the cavity 3. In addition, a fastening and release device can also be provided in order to mechanically securely connect the pickup 2 and the attachment 1 received by the pickup 2 to one another in a non-positive or positive connection.

In addition, it can also be provided to provide a constriction in the sample container 5, which is bent at an angle between 1 ° and 179 ° with respect to the sample filling direction, on the one hand to enable easy filling of the sample container 5 with the sample, but on the other hand also to keep the sample safe to hold and to prevent involuntary release of the sample from the sample container 5, especially during the opening process of the cover 4. In general, a bend at any angle that is not coaxial to a flow direction can be considered. Alternatively or in addition to a curved constriction, a constriction serving as a “valve” can also be provided, which increases the flow resistance and thus prevents the sample from flowing out of the sample container 5, again in particular during the opening process. In the exemplary embodiments shown in Figures 1 and 2 the attachment 1 is shaped complementary to the opening of the receiver 2 closed by the cover 4, ie the opening element 7 is shaped in particular to fit or precisely fit this opening. In addition, since the base body 8 is connected to the holding device 9 has a closed surface, the cavity 3 can be closed all around by the sensor 2 even after the cover 4 has been opened.

3 shows a further exemplary embodiment of a sample receiving device in a view corresponding to FIG. Figure 4 shows, in a view corresponding to Figure 2, the assembled state of the receiver 2 and attachment 1. The surface normal of the end surface forms an angle of 60° with the longitudinal axis of the attachment 1 or the sample container 5, i.e. H. there is a pointed end with which the cover 4 can be pierced more easily.

Figure 5 shows a sectional view of an exemplary embodiment of the attachment 1, in which the sample container 5 is no longer arranged centrally along the longitudinal axis, but is spatially offset and runs parallel to this longitudinal axis. The outlet opening 6 has a surface normal which is also parallel to the longitudinal axis and coincides with a longitudinal axis of the sample container 5, while the opening element 7, which is still designed in one piece, has a beveled end surface with a tip. As a result, the cover 4 can be easily penetrated without the outlet opening and thus possibly the sample coming into contact with the cover 4. In Figure 6, the attachment 1 shown in Figure 5 can be seen in a sectional view in a state inserted into the receiver 2. The opening element 7 is designed to be longer than the sample container 5, i.e. has a greater length than the sample container 5.

Figure 7 shows in the left part in a side view, in the middle part in a side sectional view and in the right part in a perspective sectional view, an embodiment of the attachment 1, in which the capillary-shaped sample container 5 has an additional container 14 at its end facing away from the outlet opening 6 is connected as an additional cavity so that more volume is available to hold the sample. The tunnel-shaped additional container 14 has two outlet openings 13 opposite one another and its longitudinal axis is orthogonal to the longitudinal Axis of the attachment 1 or the sample container 5 and the additional container 14 are arranged. An orthogonal arrangement should be understood to mean an angle of between 85° and 95°, preferably 90°, between the longitudinal axis of the attachment 1 and the longitudinal axis of the additional one. The outlet opening 13 or the outlet openings 13 are located at a corresponding spatial distance from the end surface of the opening element 7 and the outlet opening 6 laterally on the attachment 1, so that a tunnel-shaped configuration is possible. Figure 8 reveals the attachment 1 shown in Figure 7 in the state inserted into the receiver 2, the attachment 1 and the holder 2 being flush with one another on their top side.

In the embodiments shown in Figures 8 and 9, a one-step process or a two-step process can be carried out. In the one-step process, the sample holder 5 is first inserted into the opening element 7 and both together are then inserted into the holder 2. In the two-step process, the sensor 2 is first opened by the opening device 7 and then the sample container 5 is introduced. The flexibility of the sample containers 5 used can be increased and, for example, simple sample containers 5 such as a pipette, a sponge or a dropper can also be used.

The fact that the opening element 7 and the sample container 5 can also be designed in several parts is shown in a perspective view in FIG. The sensor 2 corresponds to the exemplary embodiments already discussed, but the opening element 7 is now an attachment to the sensor 2, which has a beveled end surface at the end of a tubular element 10. The base body 8 with the sample container 5 can be inserted into the tubular element 10, which are now designed as a separate component. The attachment 1 itself is therefore designed in two parts and includes the opening element 7 and the sample container 5, which is formed in one piece with the base body 8. To insert it, the opening element 7 is first placed on the receiver 2 and the cover 4 is opened. The base body 8 with the sample container 5 is then inserted into the resulting opening. The assembled state is shown in Figure 10 in a view corresponding to Figure 9. While with a one-piece design the opening element 7 has to be longer than the sample container 5 (in order to first come onto the cover 4 and pierce it), this is not necessarily necessary with the two-part structure. Since the opening element 7 may be introduced into the receiver 2 first, the sample container 5 subsequently inserted into the opening element 7 can also have a greater length than the opening element 7.

In a further embodiment shown in Figure 11 in a representation corresponding to Figures 9 and 10, the receiver 2 and the opening element 7 are mechanically connected to one another, in the example shown in Figure 11 by a hinge-shaped connection. As before, the sample container 5 can be inserted into the tubular element 10 after penetrating the cover 4. This condition is shown in Figures 12 and 13.

In addition, the sensor 2 can also be provided with several chambers or cavities, each of which is separated from one another by covers. 14 shows a sectional view of the sensor 2, in which a further cover 12 is now present in addition to the cover 4. A first substance can therefore be contained in the cavity 3 as the first chamber, while another substance can be contained in the second chamber 11 formed between the cover 4 and the second cover 12 as a further cavity or cavity. Thus, when the opening element 7 is introduced, the further cover 12 and then the cover 4 are pierced one after the other and the reagents in turn first mix with the sample in the cavity 3.

As shown in Figure 15, it is also possible to modify the basic shape of the transducer 2 shown on the left in Figure 15 in such a way that several transducers 2 are arranged side by side in one piece (two in the middle part of Figure 15, three in the right part). In this case, the cavities 3 typically have longitudinal axes that run parallel to one another. The cavities 3 can also each have different volumes.

Only features of the different embodiments disclosed in the exemplary embodiments NEN embodiments can be combined with one another and claimed individually.

Claims

Claims Sample receiving device with an attachment (1) and a receiver (2), the receiver (2) having a cavity (3) that is open on one side and closed with a cover (4), so that the cavity (3) is opened by means of the cover (4). is sealed against the environment, and the attachment (1) has a base body (8) with a sample container (5) with an outlet opening (6) and an opening element (7), the opening element (7) being designed such that through a Pressing the opening element (7) onto the cover (4), the cover (4) can be penetrated by the opening element (7), and the attachment (1) is placed on the receiver in this way

(2) can be placed and fastened so that the sample container (5) with the outlet opening (6) and the opening element (7) in the cavity

(3) are arranged, wherein the sample container (5) and the opening element (7) are arranged pointing away from the base body (8) when placed on the sensor (2). Sample receiving device according to claim 1, characterized in that the sample container (5) is designed in one piece with the opening element (7). Sample receiving device according to claim 1, characterized in that the sample container (5) and the opening element (7) are divided into two parts. are designed lig and the sample container (5) can be inserted or received into a recess in the opening element (7).

4. Sample receiving device according to one of the preceding claims, characterized in that the sample container (5) and the opening element (7) are arranged, can be arranged or aligned with one another concentrically or parallelly along the longitudinal axis of the attachment (1).

5. Sample receiving device according to one of the preceding claims, characterized in that an additional container (14) connected to the sample container (5) is arranged, can be arranged or aligned at right angles to the opening element (7).

6. Sample receiving device according to one of the preceding claims, characterized in that the cover (4) is designed as a sealing plate or sealing film.

7. Sample receiving device according to one of the preceding claims, characterized in that the cavity (3) is designed as a reservoir containing a reagent.

8. Sample receiving device according to one of the preceding claims, characterized in that the opening element (7) has a beveled end facing away from the base body (8), which is preferably at an angle between 0.1° and 89°, preferably 45° to 60°, is particularly preferably angled at 60°.

9. Sample receiving device according to one of the preceding claims, characterized in that the attachment (1) has a holding device (9) which is arranged on a side of the base body (8) facing away from the sample container (5) and the opening element (7).

10. Sample receiving device according to one of the preceding claims, characterized in that on the sensor (2) and / or on A fastening and release device is arranged on the attachment (1). Method for picking up and handling a sample with a device according to one of claims 1 to 10, in which a sample is picked up in the sample container (5) and the attachment (1) is placed on the receiver (2) in such a way that by pressing the Opening element (7) on the cover (4) the cover (4) is penetrated and the attachment (1) is placed on the receiver (2) and fastened in such a way that the sample container (5) with the outlet opening (6) and the opening element (7) are arranged in the cavity (3).