WO2019072356A1

WO2019072356A1 - Stool sample collection kit

Info

Publication number: WO2019072356A1
Application number: PCT/EP2017/001211
Authority: WO
Inventors: Gregor Kern
Original assignee: KME Kern Medical Engineering GmbH
Priority date: 2017-10-13
Filing date: 2017-10-13
Publication date: 2019-04-18

Abstract

The present invention relates to a stool sample collection kit having a stool sample container, which has a chamber with preserving liquid, and having a collecting element with a handle region and with a collecting region for collecting a defined quantity of stool, wherein the collecting element is insertable into the stool sample container such that the collecting region enters the chamber containing the preserving liquid, and wherein the collecting element, in the position when inserted into the stool sample container, can be locked to the stool sample container via a once-only lock, wherein the once-only lock catches after the insertion of the collecting element into the stool sample container and prevents release of the collecting element from the stool sample container. The invention is characterized in that, in the delivery state, the chamber with preserving liquid is closed tightly, by a sealing element, which is opened only by the insertion of the collecting element into the stool sample container.

Description

Stuhlprobenaufnahmeset

The present invention relates to a stool sample receptacle for receiving a stool sample having a stool sample container and a receiving element. Such stool sampling kits are used in particular for performing intestinal cancer tests. In this case, a stool sample is taken by means of the - usually rod-shaped - receiving element and first introduced into the stool sample container, which has a chamber with preservative liquid. From this stool sample container, the preservation liquid with the stool sample dissolved therein can then be removed to undergo a test.

WO 2013/107893 A1 discloses such a stool sample receptacle. This has a stool sample container in the form of a stool sample tube, in which a chamber with preservation liquid is arranged. As a receiving element, a rod is provided at the free tip of a receiving opening is provided for receiving a defined amount of chair. The rod is disposed on a handle portion and can pass through a funnel-shaped ring plate into the chamber with preservative liquid be inserted so that the stool sample present in the receiving area is dissolved in the preservative liquid. The funnel-shaped annular plate has a sealing lip, which abuts both in the delivery state, as well as after receiving the stool sample on the rod and thereby seals the chamber to the outside.

The receiving stick of WO 2013/107893 A1 is locked in two positions on the stool sample tube. The first position defines the delivery condition, with the latch easily releasable to pull the picker stick out of the stool sample container. After picking up a stool sample and inserting the receiving stick into the stool sample container, the receiving stick can be advanced to a second position where it is latched to the stool sample container via a one-time latch. The one-time locking locks in the second position and prevents loosening of the receiving element of the stool sample container.

The stool sample receiving set known from WO 2013/107893 A1 has, in a first exemplary embodiment, a two-stage stool sample container, with a first chamber, into which the receiving stalk can be inserted, and a second chamber, into which a defined amount of liquid can be introduced from the first chamber. In a second embodiment, however, only a single chamber is provided into which the receiving rod is insertable.

The stool sampling set known from WO 2013/107893 A1 requires very careful handling in order to achieve reproducible results. For the standard care with little attentive patients who should take the stool sample itself, the Stuhlprobenaufnahmeset is therefore only conditionally suitable.

It is therefore an object of the present invention over the prior art to provide a stool sample receiving set which is easy to operate. This object is achieved by Stuhlprobenaufnahmesets according to claim 1 and according to claim 8. Advantageous embodiments of the present invention are the subject of the dependent claims.

The present invention, in a first aspect, comprises a stool sampling set having a stool sample container having a chamber with preservative liquid, and a receptacle having a handle portion and a receiving area for receiving a defined amount of stool. The receiving element is inserted into the stool sample container so that the receiving area passes into the chamber with preservative liquid. Furthermore, the receiving element in the inserted into the stool sample container position via a one-time lock with the stool sample container is locked, the one-time locking locked after insertion of the receiving element in the stool sample container and prevents detachment of the receiving element of the stool sample container. According to the invention the chamber is sealed with preservative liquid in the delivery state via a sealing element, which is opened only by the insertion of the receiving element into the stool sample container.

The combination of a one-time locking device and a sealing element according to the invention reliably prevents operating errors of the stool sampling set. Namely, the inventor of the present invention has recognized that in prior art stool sampling sets many users tend to insert the receiving stick into the stool sample container several times in succession to stuff as much stool as possible into the stool sample container. However, if users introduce too much stool into the receptacle, this will lead to errors in the evaluation of the stool sample since the tests usually performed are based on a defined amount of stools.

The sealing element according to the invention in combination with the one-time locking prevents the user from introducing stool samples into the chamber several times can. Because without opening the sealing element no chair can get into the chamber. The one-time locking then prevents a repeated release of the receiving element from the stool sample container and thus a repeated loading. The one-time locking system known from WO 2013/107893 A1 can not afford this, since it is still possible because of the missing sealing element to insert any number of chairs into the first chamber as often as desired.

In a preferred embodiment of the present invention, the relative movement between the receiving element and stool sample containers, through which the sealing element is opened, also leads to a locking of the disposable latch. In particular, the sealing element can not be opened and chair can not be introduced into the chamber without simultaneously locking the disposable latch. After the single insertion of the receiving area of the receiving element into the chamber, the receiving element can then no longer be detached from the stool sample container.

In one possible embodiment of the present invention, the receiving element can close the chamber after opening the sealing element. As a result, the chamber is sealed even after the opening of the sealing element. For this purpose, the receiving element preferably lies sealingly against the sealing element after opening. Alternatively, the receiving element can also rest on a different sealing element than that which closes the chamber in the delivery state.

In one possible embodiment of the present invention, the sealing element may comprise a movable element, which in the delivered state closes the chamber and is moved by the insertion of the receiving element so that the receiving region of the receiving element is insertable into the chamber. For example, it may be provided a stopper, which is pushed through the receiving element into the chamber. In a preferred embodiment of the present invention, however, the sealing element closes the chamber with preservative liquid in the delivery state, a material fit. In particular, the sealing element may have a continuous material layer which seals the chamber.

Preferably, the sealing element is penetrated to open the chamber of the receiving element. Such a bonded closure ensures a long shelf life of the unused stool sampling set, and is easy to manufacture. Preferably, the receiving element thus penetrates the previously continuous material layer of the sealing element for opening the sealing element.

Preferably, the material of the sealing element is in the penetrated state sealingly against the receiving element, so that the chamber is still closed even when the receiving element has pierced the sealing element. In particular, the material layer of the sealing element can bear sealingly against the outer circumference of the receiving element.

In one possible embodiment, the sealing element has a predetermined breaking point, which is pierced by the receiving element. In one possible embodiment, the predetermined breaking point may be a region of the continuous material layer with a lower material thickness in order to simplify piercing. In this case, a region of the sealing element can be released during the piercing out of the sealing element, and / or the sealing element is deformed during piercing.

Preferably, the predetermined breaking point corresponds to the cross section of the receiving element, which pierces the sealing element. Alternatively or additionally, the predetermined breaking point is configured such that the region of the sealing element surrounding the predetermined breaking point seals against the receiving element in the pierced state. In particular, the cross section of the predetermined breaking point for this purpose may be smaller than the frontal cross section of the receiving element. Alternatively or additionally, the receiving element may have a tapered end face, which simplifies a penetration of the sealing element.

In a first embodiment, the sealing element may consist of a hard, fracture-permitting material and, in a second embodiment, of a deformable and / or elastomeric material.

The receiving region of the receiving element preferably has a receiving cavity arranged on an end face of the receiving element. This receiving cavity preferably has a defined volume, which corresponds to the target removal amount of chair.

In one possible embodiment, the edge regions of the end face of the receiving element surrounding the receiving cavity are located on the sealing element when it is opened, so that the amount of stool contained between the receiving area and the sealing element during opening of the sealing element is defined solely by the volume of the receiving cavity.

In a first embodiment, the edge regions can rest flat on the sealing element. In this case, a region of the sealing element surrounded by the predetermined breaking point is preferably broken off during the breaking through of the sealing element.

In a second embodiment, the edge regions can taper to allow a piercing of the sealing element. In this case, the sealing element is preferably made of an elastomeric material, so that the material of the sealing element bears against the oblique outer surfaces of the edge regions during piercing of the sealing element. The tapered edge regions are Favor dimensioned so that they are completely arranged in the pierced state in the chamber, and the material of the sealing element rests against a cylindrical outer surface of the receiving element. In one possible embodiment, the tapered edge regions may surround the cavity in an annular manner.

In particular, thereby adhere to the tip of the receiving element adhering chair when placing the end face of the receiving element on the sealing element to the side and thus does not enter the chamber when opening the sealing element.

In an alternative embodiment, the edge regions of the cavity run obliquely to the direction of movement of the receiving element, thus forming a tip.

Furthermore, the peripheral regions of the end face surrounding the receiving cavity can be guided along the sealing element as it passes through, so that excess chair is stripped off.

The stool sample container may further comprise a conical guide ring, through which the receiving element is guided during insertion in the direction of the sealing element. In addition to the guiding function of the guide ring also serves as a scraper for excess chair, which adheres to the side of the receiving element. Preferably, the opening of the conical guide ring corresponds to the cross section of the receiving element.

The receiving element according to the invention may have a rod arranged on the handle region, the free tip of which forms the receiving region and which can be inserted into the receptacle. In a preferred embodiment, the rod has a round cross-section. Preferably, the conical guide ring and / or the predetermined breaking point of the sealing element also has a circular cross section.

In one possible embodiment of the present invention, the one-time locking is formed by latching elements, which on the Gripping area of the receiving element and a first end face of the stool sample container are provided.

The latching elements may include a run-up slope and a locking edge. By sliding on the run-in slope, the lock can be made, the locking edge provides a lock.

Preferably, the locking of the disposable latch is designed so that the receiving element can only be removed by force from the stool sample container.

In one possible embodiment of the present invention, the two elements of the stool sample collection set, i. the stool sample container and the receiving element are delivered separately and are connected together only after the stool sample has been taken.

In an alternative embodiment, however, the stool sample container and the receiving element are already delivered interconnected. This facilitates the handling of the stool sampling set.

The present invention, in a second aspect, comprises a stool sample containment kit having a stool sample container having a chamber with preservative liquid and a receptacle having a handle portion and a receiving area for receiving a defined amount of stool. In this case, the receiving element is inserted into the stool sample container so that the receiving area passes into the chamber with preservative liquid. In a first variant of the second aspect, a spacer between receiving element and stool sample container is provided in the delivery state. The spacer prevents in the delivery condition a complete insertion of the receiving element in the stool sample container. In a second variant of the second aspect, the receiving element is attached via a single connection to the stool sample container. The one-time connection ensures the delivery status for a secure connection between the receiving element and stool sample container. However, once the disposable connection has been released, the receiving element and the stool sample container can not be reconnected in the same position. This facilitates the proper use of the stool sampling kit.

Both variants of the second aspect of the present invention can be used individually without the respective other variant. Preferably, however, the two variants are realized in combination. In particular, the spacer can simultaneously provide a one-time connection and / or the one-time connection comprise a spacer.

In the delivery state, the receiving element is preferably partially introduced into the stool sample container, but the receiving region is arranged outside the chamber with preservative liquid. Preferably, the spacer is provided between receiving element and stool specimen holder so that it prevents insertion of the receiving area into the chamber with preservative liquid.

The one-time connection is preferably designed as a material-locking connection, which is broken to disconnect the connection. Preferably, a predetermined breaking point is provided for this purpose. In particular, the one-time connection may be implemented via a plastic part, which is in communication with the receiving element and the stool sample container and is withdrawn or broken off for opening. The predetermined breaking point may in particular be a predetermined breaking line. Alternatively or additionally, the predetermined breaking point may be an area of lesser material thickness and / or recesses in a continuous material layer.

In a preferred embodiment of the second aspect of the spacer is in the delivery state by a one-time connection with the receiving element and the stool sample container in connection. In particular in each case a single connection between the spacer and the receiving element, and provided between the spacer and the stool sample container. In this case, the one-time connection is in turn designed to be material-locking and is broken open to disconnect the connection.

In one possible embodiment of the present invention, the spacer can be arranged between an end-side edge region of the stool sample container and the grip region of the receiving element. Alternatively or additionally, the spacer can be designed annular. Preferably, the spacer is withdrawn annular to open the one-time connection.

The stool sampling set according to the second aspect may be embodied in a possible embodiment without the further features of a stool sampling set according to the first aspect of the present invention. Preferably, however, the stool sample receiving set according to the second aspect has one or more of the features set forth above with respect to the stool sample taking set according to the first aspect.

Specifically, in the stool sample receiving set according to the second aspect, the receiving member can be locked in the inserted into the stool sample container position via a one-time lock with the stool sample container, the one-time locking locks after insertion of the receiving element in the stool sample container and prevents detachment of the receiving element from the stool sample container.

Alternatively or additionally, in the stool sample receiving set according to the second aspect, the chamber may be tightly sealed with preservative liquid in the delivery state via a sealing element, which is opened only by inserting the receiving element into the stool sample container. Preferably, it is provided in this case that the spacer prevents opening of the sealing element in the delivery state. In one possible embodiment, the spacer can hold the receiving element in the delivery state in a position in which the end face of the receiving element rests on the sealing element. By removing the spacer this can then be moved with a relatively short distance against the sealing element to open this and preferably to break through.

The stool sampling set according to the second aspect preferably has those features which have already been described in detail above with regard to the first aspect.

Preferred embodiments of a stool sampling set both according to the first and in the second aspect are shown in more detail below:

Preferably, the stool sample container in the form of a tube. In particular, the tube may have on a first end face an opening for insertion of the receiving element. Preferably, the one-time locking takes place in the region of this first end side, and more preferably with a grip region of the receiving element.

Alternatively or additionally, the stool sample container and preferably the tube on a second end face have a removal arrangement for removing the sample from the chamber. In a first embodiment, the removal arrangement may be formed by an injection point of an elastomeric material. In a second embodiment, the removal arrangement may be formed by a demolition nipple. This allows a quick test.

The receiving element may comprise a rod whose free tip forms the receiving area. Preferably, the outer surface of the rod is executed without depressions, so that there can accumulate no stool residues. Preferably, the rod is in communication with the grip area. The rod is preferably inserted into the stool sample container in the form of a tube.

The stool sample container according to the invention preferably has a single chamber filled with preservation liquid. The receiving area of the receiving element can be introduced directly into this chamber to solve the recorded in the receiving area chair in the preservative liquid. The removal arrangement preferably allows direct removal of the preservation liquid from the chamber.

For receiving a stool sample, the receiving element is separated from the stool sample container, in particular by pulling out of the receiving element from its partially inserted into the stool sample container position. In a stool sample receiving set according to the second aspect of the present invention, in this case, a release of the disposable connection and / or removal of the spacer takes place.

Then, the receiving area of the receiving element is brought into contact with the chair, for which purpose the receiving element gripped at its grip area and the receiving area is guided into the chair. As a result, a stool sample is received in the receiving area, in particular in a receiving cavity of the receiving area.

Next, the receiving member with the receiving portion is inserted into the stool sample container until the receiving portion is in the chamber. By shaking the stool sample taken in the receiving area can now be dissolved in the preservative liquid.

In addition to the stool sample collection kit, the present invention further includes a stool sample container for such a stool sample collection set as described above. Such a stool sample container can in a possible Embodiment be provided separately from the receiving element.

The present invention further encompasses the use of a stool sample receptacle of the present invention as described above for conducting a colon cancer test. The stool sampling kit can be used to take a stool sample.

Preferably, this stool sample is evaluated for performing a Darmkrebstestes. For this purpose, the preservative liquid with the stool sample contained therein is preferably removed from the chamber and analyzed. This can be done quantitatively in a special laboratory designed for this purpose, or qualitatively by means of a rapid test on site.

In particular, an immunological colon cancer test can be performed.

The present invention will now be described in more detail with reference to embodiments and drawings.

Showing:

1 shows an embodiment of a receiving element for a Stuhlprobenaufnahmeset invention,

Fig. 2: two variants of an embodiment of an inventive

Stool samples container,

Fig. 3: an embodiment of a in an inventive

Stool sample container arranged guide ring,

4 shows an embodiment of an invention in a

Stool sample container arranged sealing element, 5 shows an embodiment of a spacer according to the invention between stool sample container and receiving element and disposable connector,

Fig. 6: the embodiment of an inventive

Stool sample sets in delivery condition,

Fig. 7: the use of a receiving element according to the invention for

Recording a stool sample,

Fig. 8: the embodiment of an inventive

Stool sample sets in a state in which the stool sample was introduced into the chamber, and

Fig. 9: an embodiment of an inventive

Stool sample sets with a first alternative embodiment of the receiving area and the sealing element,

10 shows an embodiment of an inventive

Stool sampling sets with a second alternative embodiment of the receiving area and the sealing element, and

11a and 11b: the penetration of the sealing element through the

Receiving element in the embodiment shown in Fig. 10.

An embodiment of a Stuhlprobenaufnahmesets invention will now be described with reference to figures 1 to 8 in more detail. The stool sampling kit consists of the following parts:

The receiving element 2 shown in Fig. 1, with a formed by the tip 5 of a rod 3 receiving area for a stool sample and with an am The gripping region 4 and the receiving region 5 are shown enlarged again in FIG. 1 in each case.

The rod 3 has on its front side 5 a defined cavity 6, in which an exact amount of chair fits. In the embodiment, the cavity 6 is designed so that it can accommodate 10 milligrams chair. The cavity 6 is circumferentially enclosed by edge regions 7 of the end face 5 of the rod 3.

The outer surface of the rod 3 is executed in the embodiment completely smooth and without grooves. In the exemplary embodiment, the rod 3 and preferably the entire receiving element 2 is made of solid plastic.

The grip area 4 has a one-time lock 8, which can only be closed once and then locked. The one-time lock thus forms a single closure. In principle, such a one-time lock could also be combined with a screw thread. The Einzelarretierung would then prevent screwing. In the exemplary embodiment, however, a screw thread has been dispensed with. The receiving element 2 can therefore be connected by a pure sliding movement with the stool sample container.

FIG. 2 shows two variants of an exemplary embodiment of a stool sample container 1 or 1 'according to the invention. The receptacle 1, 1 'each has a chamber 18, in which a preserving liquid 16 is located. At one end, the stool sample container 1, 1 'has an opening 1 1, via which the rod 3 of the receiving element 2 can be inserted into the interior of the stool sample container 1, V and in particular into the chamber 18 with the preserving liquid 16. In the exemplary embodiment, the opening 11 is arranged on a neck element 13, which has a pawl 12 which cooperates with the pawl 8 of the receiving element 2 to provide the one-time detent.

At the other end, the stool sample container 1, 1 'has a removal arrangement. In the variant 1 shown on the left in FIG. 2, a pierceable silicone cover 14 is provided. This variant serves for a laboratory test. In the variant 1 'shown on the right in FIG. 2, on the other hand, a demolition nipple 15 with predetermined breaking point is provided as removal arrangement. This variant is used for a quick test.

In the exemplary embodiment, the stool sample container is designed as a tube, wherein the opening 11 is arranged on an upper end side, the removal arrangement 14 or 15 at a lower end side of the tube.

FIGS. 3 and 4 now show two elements which are arranged inside the stool sample container 1, 1 ':

3 shows a guide ring 17 with an opening 19, which is surrounded by a conical surface 18. The guide ring 17 serves as a guide for the rod 3 of the receiving element 2 when inserted into the receptacle 1, 1 '. The rod 3 can be accurately pushed through the opening 19, so that the conical surface 18 at the same time serves as a retaining mechanism for retaining excess, adhering to the outside of the rod 3 chair.

FIG. 4 shows a sealing element 20 which, when delivered, seals the chamber 18 with the preserving liquid 16. The sealing element 20 has a predetermined breaking point 22, which can be broken through by the rod 3 of the receiving element 2, so that the receiving region 5 can be pushed into the chamber 18 with the preserving liquid 16. In the exemplary embodiment, the sealing element 20 is designed as a plate sealing the chamber. The plate has a predetermined breaking point 22, which has the same or a slightly smaller diameter than the rod 3. The predetermined breaking point is designed as a region with a smaller thickness within the consisting of a continuous material layer plate. After piercing the predetermined breaking point 22, the plate part 21 located within the predetermined breaking point 22 is released from the sealing element 20, and the edges of the predetermined breaking point lie sealingly against the outer surface of the rod 3. The sealing element is preferably made of plastic and / or a rigid and / or an elastomeric material.

The sealing element 20 is in the delivery state materially connected to the stool sample container 1, 1 'and can be glued for example in this. The sealing element 20 is completely sealed in the delivery state and thus prevents leakage of the preservative liquid 16 in the upper region of the receptacle 1, 1 '.

Fig. 5 shows a spacer 23, which simultaneously serves as a one-time connection, and which in the delivery state, the receiving element 2 and the stool sample container 1, 1 'connects. The spacer 23 is annular and is connected via predetermined breaking points 25 and 24 respectively cohesively with the stool sample container 1 on the one hand and the handle portion 4 of the receiving element 2 on the other hand in combination.

To open the test, the spacer 3 must be pulled over the grip area 26 once completely around the stool sample container 1, 1 'and the receiving element 2. Thereafter, the receiving element 2 can be taken out of the stool sample container 1, 1 '. After the single opening of the spacer 23 is no longer needed, and also allows no reconnection between the receiving element 2 and the stool sample container 1, 1 '. FIG. 6 shows the delivery state of the stool sample receiving set according to the invention. The sealing element 20 is cohesively arranged in the stool sample container 1, V and preferably glued in this. The sealing element 20 thereby seals the chamber 18 with the preserving liquid 16 upwards.

In the stool sample container 1, 1 ', the guide ring 17 is arranged above the sealing element. In the embodiment shown in Fig. 6, the sealing member 20 and the guide ring 17 are spaced from each other. In a possible alternative embodiment, however, the guide ring 17 and the sealing element 20 could also follow one another directly, and possibly also be made in one piece.

The grip area 4 of the receiving element 2 is connected via the spacer 23 to the stool sample container 1, 1 '. The spacer 23 extends between a lower edge of the handle portion 4 and an upper edge of the housing of the stool sample container 1, 1 ', and therefore keeps them at a defined distance.

In the exemplary embodiment, the connection between the spacer 23, the handle portion 4 and the stool sample container 1, V respectively produced via cohesive predetermined breaking points, which must be torn open to remove the spacer.

As shown in Fig. 6 in the detail view above, the pawls are 8 and 12 on the receiving element and the stool sample container 1, V in the state of delivery disengaged. The rod 3 is partially inserted through the opening 1 1 in the upper half of the stool sample container 1, V. The spacer 3 prevents further insertion of the receiving element 2 in the stool sample container 1, V and thus locking the disposable detent, which is formed by the pawls 8 and 12, or opening of the sealing element 20th As shown in FIG. 6 in the lower detail view, the receiving area 5 of the rod 3 is in the delivery state on the sealing element 20. The predetermined breaking point 22 is closed. The preservation liquid 16 is located in the chamber 18 below the sealing element 20, which prevents leakage upwards.

For the use of the stool sampling set the patient triggers the spacers 23 designed as a spacer ring, which is attached via thin plastic connections 24 and 25 to receiving element 2 and stool sample containers 1, 1 '. Thus, as shown in Fig. 7, the receiving element 2 is released. The patient now takes the receiving element 2 by grasping it on the grip area 4 and takes a stool sample. This is done by pushing the receiving area formed by the tip 5 of the rod 3 into a larger amount of chair. As a result, the cavity 6 of the receiving area 5 is filled with chair.

Thereafter, the patient inserts the rod 3 through the opening 11 in the stool sample container 1, 1 'back. The guide ring ensures centering of the rod 3, and wipes excess chair, which adheres to the outside of the rod 3, from.

By inserting the rod 3, its tip 5 initially comes into contact again with the sealing element 20, as shown in detail view in FIG. 6. As a result, the edge regions 7 of the end face of the rod 3 together with the sealing element 20 enclose the cavity 6. Excess stool is thereby pushed aside.

By further pressure on the grip area 4 of the receiving element 2, two things now happen simultaneously:

1. The one-time lock locks. As a result, the receiving element 2 can no longer be removed from the stool sample container 1, 1 ', at least not without the use of force. In the embodiment, this is characterized achieved by the further pressure, the respective run-on slopes on the handle 4 and the stool sample container 1, V slide on each other until the locking edges 8 and 12 lock together.

2. The receiving portion 5 of the rod 3 breaks through the sealing element 20 and thereby passes into the chamber 18. The liberated by the cutting of the annular predetermined breaking point 22 from the sealing member 20 platelets 21 falls down into the chamber. The predetermined breaking point 22 is designed so that its edge bears sealingly on the outer circumference of the rod 3. This results in the inserted state, a seal of the chamber 18 upwards.

Due to the penetration of the sealing element 22, the stool sample received in the cavity 6 comes into contact with the preservation liquid 16 within the chamber 18.

The patient now only has to shake the stool sample container 1, 1 'with the receiving element 2 locked thereon in order to release the stool sample in the preservation liquid. The stool sample container 1 thus contains a precisely predetermined concentration stool.

This state is shown in FIG. 8, wherein the one-time lock is shown at the top in the detail view, and at the bottom the seal element 20 which is interrupted by the receiving area 5 of the rod 3.

9 shows a first alternative embodiment of the receiving area 5 and the sealing element 20 of a stool sample receiving set according to the invention.

As in the previously illustrated embodiment, the rod 3 has at its end face 5 forming the receiving region a defined cavity 6 into which an exact amount of chair fits. In the embodiment, the cavity 6 is again designed so that this 10 milligrams chair can record. The cavity 6 is circumferentially enclosed by edge regions 7 of the end face 5 of the rod 3.

Unlike in the first embodiment, the end face 5 of the rod 3 in the embodiment shown in FIG. 9, however, is not flat, but designed tapered. For this purpose, the edge regions 7 surrounding the cavity 6 have an outer bevel 27, which surrounds the cavity 6 in an annular manner. However, the front edge of the edge regions 7 continues to extend in a plane perpendicular to the extension of the rod.

Due to the pointed configuration of the front side 5 of the rod 3, this pierces the sealing element 20 when the rod is pressed against the sealing element. First, the front edge of the edge regions 7 comes into contact with the sealing element and thereby encloses the cavity 6 together with the sealing element. The edge regions 7 then pierce the material of the sealing element 20. This results, on the one hand, in adhering to the edge regions 7 of the front side Chair is safely stripped and does not enter the chamber 18. Furthermore, a secure seal of the chamber is also secured when the tip of the rod has been pushed through the sealing member into the chamber 18.

The sealing element 20 is preferably made of an elastomeric material, eg. Silicone, made. This allows on the one hand a piercing, and on the other hand a close concern of the pierced area on the outer surfaces of the rod 2. The area to be pierced portion 22 of the sealing element may have a predetermined breaking point. In the exemplary embodiment, this predetermined breaking point 22 is designed as a region of lesser material thickness. However, such a predetermined breaking point is not absolutely necessary depending on the thickness of the sealing element.

In one possible embodiment, the sealing element 20 made of an elastomeric material may also be connected to a ring element 28 made of a rigid material which seals the sealing element in an edge area supports and so simplifies a piercing. The sealing element can rest on such a ring element 28, for example.

10 shows a second alternative embodiment of the receiving area 5 and the sealing element 20 of a stool sample receiving set according to the invention.

As in the previously described exemplary embodiments, the rod 3 has a defined cavity 6 on its end face 5 forming the receiving region, into which an exact quantity of chair fits. In the embodiment, the cavity 6 is again designed so that it can accommodate 10 milligrams chair. The cavity 6 is circumferentially enclosed by edge regions 7 of the end face 5 of the rod 3.

The front edge of the cavity 6 surrounding edge regions 7 extends in the second alternative embodiment obliquely to the longitudinal axis of the rod and thereby forms a tip 29, which allows piercing of the sealing element 20.

Fig. 11 a) shows the penetration of the sealing element 20 through the tip 29. Unlike in the embodiments described above, the edge regions 7 are no longer here over the entire circumference of the cavity 6 on the sealing element. However, the front edge of the edge regions 7 slides along when piercing the sealing element, so that the sealing element strips off excess chair when piercing. This also ensures that the introduced into the chamber amount chair is defined solely by the volume of the cavity 6.

Also in the second alternative embodiment, the sealing element 20 is preferably made of an elastomeric material, eg. Silicone, made. This allows on the one hand a piercing, and on the other a close concern of the pierced area on the outer surfaces of the rod 2, as shown in Fig. 11 b). The region 22 to be pierced by the sealing element includes the embodiment shown in Fig. 10 and 11 no predetermined breaking point more. Rather, the sealing element 20 is so thin and the tip 29 designed so sharp that a penetration is possible even without a predetermined breaking point.

In the embodiment shown in FIGS. 10 and 11, the sealing element 20 made of an elastomeric material is in turn connected to a ring element 28 made of a rigid material, which supports the sealing element in an edge area and thus simplifies puncturing.

The alternative embodiments illustrated in FIGS. 9 to 11, except for the differences described above, correspond to the exemplary embodiment shown in FIGS. 1 to 8, so that with regard to the further features of the stool sampling set, reference may be made to the description there.

The Stuhlprobenaufnahmeset invention has the advantage that the recorded amount of stool can not be deliberately manipulated. In particular, a repeated Vollstopfen is prevented with chair. The guide ring also prevents the breakage of the predetermined breaking point by other aids. Only with a thin rod could break open the breaking point deliberately and then stuff the chair first in the chamber under the guide ring and then in the chamber 18 with the preservative liquid 16. This is a highly unlikely scenario.

Preferably, the sealing element 20 is also transparent, which further reduces the likelihood of such manipulation.

The inventive combination of the one-time locking and the sealing element is thus ensured that a patient in no case too much chair in the chamber 18 of the stool sample container 1, 1 'brings. The stool sampling kit according to the invention is preferably used for an immunological intestinal cancer test with a fixed amount of stool. Due to its easy handling, it is suitable for standard supply.

The stool sampling kit is suitable both for a quantitative laboratory test and for a qualitative rapid test.

The spacer according to the invention with a single closure allows a particularly simple handling, since the two elements of the Stuhlprobenaufnahmesets are delivered interconnected. The spacer prevents unintentional opening of the seal. On the other hand, it establishes a one-time connection between the two elements, so that it is immediately obvious whether it is a new, unused stool sample collection set, or whether it has already been used.

However, in an alternative embodiment, the stool sample receptacle of the invention could also be provided as two separate parts. In particular, the receiving element and the stool sample container could also be delivered separately. In this case, the stool sample container 1 preferably has a cover that closes off the opening 11 in the delivery state, which prevents contamination and unintentional opening of the sealing element 20.

However, the stool sample receiving set shown in the embodiment with a receiving element connected via a spacer and disposable with the stool sample container receiving element is easier to use.

Claims

Stool sample set claims

A stool sample receptacle comprising a stool sample container and a receptacle, the stool sample container having a chamber with preservative liquid, the receptacle having a handle portion and a receptacle for receiving a defined amount of stool, the receptacle being insertable into the stool sample receptacle such that the receptacle is in place the chamber is provided with preservative liquid, and wherein the receptacle is lockable in the stool sample container via a one-time lock with the stool sample container, wherein the disposable latch locks after insertion of the receptacle into the stool sample container and prevents detachment of the receptacle from the stool sample container, characterized that the chamber is sealed with preservative liquid in the delivery state via a sealing element, which only by inserting the receiving element in de n Stool sample container opened becomes.

2. Stool sample receiving set according to claim 1, wherein the relative movement between the receiving element and stool sample containers, through which the sealing element is opened, leading to a locking of the one-time latch.

3. Stuhlprobenaufnahmeset according to claim 1 or 2, wherein the receiving element closes the chamber after opening the sealing element, wherein the receiving element is preferably sealingly applied to the sealing element.

4. Stuhlprobenaufnahmeset according to any one of the preceding claims, wherein the sealing element cohesively closes the chamber with preservative liquid in the delivery condition and is penetrated to open by the receiving element, wherein preferably the material of the sealing element in the penetrated state sealingly against the receiving element and / or wherein the sealing element a Having predetermined breaking point and / or the receiving element has a tapered end face, wherein the predetermined breaking point preferably corresponds to the cross section of the receiving element and / or preferably wherein the predetermined breaking point surrounding region of the sealing element sealingly abuts the receiving element in the open state.

5. Stuhlprobenaufnahmeset according to any one of the preceding claims, wherein the receiving portion of the receiving element has a arranged on an end face of the receiving element receiving cavity, wherein preferably the surrounding the receiving cavity edge regions of the end face during opening of the sealing element rest on this, so that when opening the sealing element between receiving area and sealing element contained amount of feces is defined solely by the volume of the receiving cavity, and / or wherein the surrounding the receiving cavity edge regions of the front side are passed during penetration of the sealing element along this, so that excess chair is stripped.

6. Stool sample receiving set according to one of the preceding claims, wherein the stool sample container has a conical guide ring, through which the receiving element is guided during insertion in the direction of the sealing element.

7. Stool sampling set according to one of the preceding claims, wherein the

Once-locking is formed by latching elements, which are provided on the handle portion of the receiving element and a first end face of the chair sample container.

8. stool sample holder with a stool sample container and a receiving element,

wherein the stool sample container has a chamber with preservative liquid,

wherein the receiving member has a handle portion and a receiving portion for receiving a defined amount of chair, and

wherein the receiving element is insertable into the stool sample container such that the receiving region enters the chamber with preservative liquid, characterized

that a spacer between receiving element and stool sample container is provided in the delivery state and / or the receiving element is attached via a disposable connection to the stool sample container.

The stool sample containment set of claim 8, wherein the receptacle is partially inserted into the stool sample container when shipped, but the receptacle is disposed outside the preservation fluid chamber, preferably wherein the spacer prevents insertion of the receptacle into the preservation fluid chamber.

10. Stool sample receiving set according to claim 8 or 9, wherein the disposable connection is designed as a material-locking connection, which is broken to separate the connection, for which preferably a predetermined breaking point is provided is.

11. The stool sample receiving set according to claim 8, wherein the spacer in the delivery state is connected to the receiving element and the stool sample container by a one-time connection, and / or wherein the spacer is arranged between an end edge region of the stool sample container and the grip region of the receiving element and / or is annular.

The stool sample containment set of any one of claims 8 to 11, wherein the receptacle is lockable in the stool sample container position via a one-time lock with the stool sample container, the disposable lock after insertion of the receptacle locks into the stool sample container and prevents detachment of the receptacle from the stool sample container , And / or wherein the chamber is sealed with preservative liquid in the delivery state via a sealing element, which is opened only by inserting the receiving element into the stool sample container, wherein the spacer preferably prevents opening of the sealing element, and / or with the features of a stool sampling after one of claims 1 to 6.

13. stool sample receiving set according to one of the preceding claims, wherein the stool sample container has the shape of a tube, wherein preferably the tube on a first end face has an opening for insertion of the receiving element and / or preferably wherein the tube on a second end side of a removal assembly for taking the sample from the chamber, wherein the removal arrangement is further preferably formed by a puncture site of an elastomeric material and / or a demolition nipple, and / or wherein the receiving element has a rod whose free tip forms the receiving area and the outer surface is preferably designed without depressions. Stool sample container for a stool sampling set according to any preceding claim.

Use of a stool sampling kit according to any one of the preceding claims for conducting a gut cancer test.