WO2019072356A1 - Ensemble de réception d'échantillon de selles - Google Patents

Ensemble de réception d'échantillon de selles Download PDF

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Publication number
WO2019072356A1
WO2019072356A1 PCT/EP2017/001211 EP2017001211W WO2019072356A1 WO 2019072356 A1 WO2019072356 A1 WO 2019072356A1 EP 2017001211 W EP2017001211 W EP 2017001211W WO 2019072356 A1 WO2019072356 A1 WO 2019072356A1
Authority
WO
WIPO (PCT)
Prior art keywords
stool sample
receiving
sample container
receiving element
stool
Prior art date
Application number
PCT/EP2017/001211
Other languages
German (de)
English (en)
Inventor
Gregor Kern
Original Assignee
KME Kern Medical Engineering GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by KME Kern Medical Engineering GmbH filed Critical KME Kern Medical Engineering GmbH
Priority to PCT/EP2017/001211 priority Critical patent/WO2019072356A1/fr
Publication of WO2019072356A1 publication Critical patent/WO2019072356A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0038—Devices for taking faeces samples; Faecal examination devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples

Definitions

  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the receiving element can close the chamber after opening the sealing element.
  • the chamber is sealed even after the opening of the sealing element.
  • the receiving element preferably lies sealingly against the sealing element after opening.
  • the receiving element can also rest on a different sealing element than that which closes the chamber in the delivery state.
  • 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.
  • 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.
  • it may be provided a stopper, which is pushed through the receiving element into the chamber.
  • the sealing element closes the chamber with preservative liquid in the delivery state, a material fit.
  • the sealing element may have a continuous material layer which seals the chamber.
  • 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.
  • the receiving element thus penetrates the previously continuous material layer of the sealing element for opening the sealing element.
  • 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.
  • the material layer of the sealing element can bear sealingly against the outer circumference of the receiving element.
  • the sealing element has a predetermined breaking point, which is pierced by the receiving element.
  • 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.
  • the predetermined breaking point corresponds to the cross section of the receiving element, which pierces the sealing element.
  • 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.
  • the cross section of the predetermined breaking point for this purpose may be smaller than the frontal cross section of the receiving element.
  • the receiving element may have a tapered end face, which simplifies a penetration of the sealing element.
  • 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.
  • 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.
  • the edge regions can rest flat on the sealing element.
  • a region of the sealing element surrounded by the predetermined breaking point is preferably broken off during the breaking through of the sealing element.
  • the edge regions can taper to allow a piercing of the sealing element.
  • 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.
  • the tapered edge regions may surround the cavity in an annular manner.
  • the edge regions of the cavity run obliquely to the direction of movement of the receiving element, thus forming a tip.
  • 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.
  • a conical guide ring 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.
  • 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.
  • the rod has a round cross-section.
  • the conical guide ring and / or the predetermined breaking point of the sealing element also has a circular cross section.
  • 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.
  • the locking of the disposable latch is designed so that the receiving element can only be removed by force from the stool sample container.
  • 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.
  • 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.
  • the receiving element is inserted into the stool sample container so that the receiving area passes into the chamber with preservative liquid.
  • 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.
  • 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.
  • the two variants are realized in combination.
  • the spacer can simultaneously provide a one-time connection and / or the one-time connection comprise a spacer.
  • the receiving element is preferably partially introduced into the stool sample container, but the receiving region is arranged outside the chamber with preservative liquid.
  • 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.
  • a predetermined breaking point is provided for this purpose.
  • 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.
  • the predetermined breaking point may be an area of lesser material thickness and / or recesses in a continuous material layer.
  • the spacer is in the delivery state by a one-time connection with the receiving element and the stool sample container in connection.
  • a one-time connection with the receiving element and the stool sample container in connection.
  • the one-time connection is in turn designed to be material-locking and is broken open to disconnect the connection.
  • the spacer can be arranged between an end-side edge region of the stool sample container and the grip region of the receiving element.
  • the spacer can be designed annular.
  • 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.
  • 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.
  • 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.
  • 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.
  • a sealing element which is opened only by inserting the receiving element into the stool sample container.
  • the spacer prevents opening of the sealing element in the delivery state.
  • 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.
  • the stool sample container in the form of a tube.
  • the tube may have on a first end face an opening for insertion of the receiving element.
  • 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.
  • the stool sample container and preferably the tube on a second end face have a removal arrangement for removing the sample from the chamber.
  • the removal arrangement may be formed by an injection point of an elastomeric material.
  • 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.
  • the outer surface of the rod is executed without depressions, so that there can accumulate no stool residues.
  • 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.
  • the receiving element 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.
  • a release of the disposable connection and / or removal of the spacer takes place.
  • 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.
  • a stool sample is received in the receiving area, in particular in a receiving cavity of the receiving area.
  • the receiving member with the receiving portion is inserted into the stool sample container until the receiving portion is in the chamber.
  • the receiving portion is in the chamber.
  • the present invention further includes a stool sample container for such a stool sample collection set as described above.
  • 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.
  • this stool sample is evaluated for performing a Darmkrebstestes.
  • 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.
  • an immunological colon cancer test can be performed.
  • Fig. 2 two variants of an embodiment of an inventive
  • Fig. 3 an embodiment of a in an inventive
  • 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
  • Fig. 7 the use of a receiving element according to the invention for
  • Fig. 8 the embodiment of an inventive
  • Fig. 9 an embodiment of an inventive
  • the stool sampling kit consists of the following parts:
  • 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.
  • 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.
  • 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.
  • such a one-time lock could also be combined with a screw thread.
  • the Einzelarret ist would then prevent screwing.
  • 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.
  • 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.
  • 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.
  • the stool sample container 1, 1 ' has a removal arrangement.
  • a pierceable silicone cover 14 is provided in the variant 1 shown on the left in FIG. 2.
  • This variant serves for a laboratory test.
  • a demolition nipple 15 with predetermined breaking point is provided as removal arrangement. This variant is used for a quick test.
  • 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 ':
  • the 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.
  • 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.
  • 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.
  • 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.
  • the guide ring 17 is arranged above the sealing element.
  • the sealing member 20 and the guide ring 17 are spaced from each other.
  • 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.
  • 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.
  • 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
  • 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.
  • 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 '.
  • 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.
  • the guide ring ensures centering of the rod 3, and wipes excess chair, which adheres to the outside of the rod 3, from.
  • the one-time lock locks.
  • the receiving element 2 can no longer be removed from the stool sample container 1, 1 ', at least not without the use of force.
  • 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.
  • 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.
  • the stool sample received in the cavity 6 comes into contact with the preservation liquid 16 within the chamber 18.
  • the stool sample container 1 thus contains a precisely predetermined concentration stool.
  • FIG. 8 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.
  • FIG 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.
  • 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.
  • 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.
  • the end face 5 of the rod 3 in the embodiment shown in FIG. 9, is not flat, but designed tapered.
  • the edge regions 7 surrounding the cavity 6 have an outer bevel 27, which surrounds the cavity 6 in an annular manner.
  • the front edge of the edge regions 7 continues to extend in a plane perpendicular to the extension of the rod.
  • 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.
  • 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.
  • FIG. 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.
  • 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.
  • 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.
  • the edge regions 7 are no longer here over the entire circumference of the cavity 6 on the sealing element.
  • 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.
  • 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.
  • 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.
  • FIGS. 9 to 11 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 Guatemalaprobenamset 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.
  • 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 Guatemalaprobeningsets are delivered interconnected.
  • the spacer prevents unintentional opening of the seal.
  • 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.
  • the stool sample receptacle of the invention could also be provided as two separate parts.
  • the receiving element and the stool sample container could also be delivered separately.
  • 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.
  • 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.

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  • Sampling And Sample Adjustment (AREA)

Abstract

La présente invention concerne un ensemble de réception d'échantillon de selles, présentant un récipient d'échantillon de selles, qui présente une chambre pourvue d'un liquide de conservation, et un élément de réception pourvu d'une zone de préhension et d'une zone de réception destinée à recevoir une quantité définie de selles, l'élément de réception pouvant être introduit dans le récipient d'échantillon de selles de manière telle que la zone de réception arrive dans la chambre pourvue du liquide de conservation et l'élément de réception pouvant être verrouillé dans la position introduite dans le récipient d'échantillon de selles via un verrouillage à usage unique avec le récipient d'échantillons de selles, le verrouillage à usage unique se bloquant après l'introduction de l'élément de réception dans le récipient d'échantillon de selles et empêchant le détachement de l'élément de réception et du récipient d'échantillon de selles. L'invention est caractérisée en ce que la chambre pourvue du liquide de conservation, dans l'état de fourniture, est fermée de manière étanche via un élément de scellage qui n'est ouvert que par l'introduction de l'élément de réception dans le récipient d'échantillon de selles.
PCT/EP2017/001211 2017-10-13 2017-10-13 Ensemble de réception d'échantillon de selles WO2019072356A1 (fr)

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PCT/EP2017/001211 WO2019072356A1 (fr) 2017-10-13 2017-10-13 Ensemble de réception d'échantillon de selles

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PCT/EP2017/001211 WO2019072356A1 (fr) 2017-10-13 2017-10-13 Ensemble de réception d'échantillon de selles

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WO2019072356A1 true WO2019072356A1 (fr) 2019-04-18

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0520408A2 (fr) * 1991-06-25 1992-12-30 Saliva Diagnostic Systems, Inc. Dispositif d'échantillonnage et système d'adéquation d'échantillon
US20080034899A1 (en) * 2004-07-12 2008-02-14 Alfresa Pharma Corporation Feces Collection Container
WO2013107893A1 (fr) 2012-01-20 2013-07-25 Bühlmann Laboratories Ag Dispositif d'extraction , de dilution et de décharge d'un échantillon
FR3023614A1 (fr) * 2014-07-10 2016-01-15 Enterome Systeme de collecte d'echantillons de matiere fecale
DE102016004686A1 (de) * 2016-04-19 2017-10-19 KME Kern Medical Engineering GmbH Stuhlprobenaufnahmeset

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0520408A2 (fr) * 1991-06-25 1992-12-30 Saliva Diagnostic Systems, Inc. Dispositif d'échantillonnage et système d'adéquation d'échantillon
US20080034899A1 (en) * 2004-07-12 2008-02-14 Alfresa Pharma Corporation Feces Collection Container
WO2013107893A1 (fr) 2012-01-20 2013-07-25 Bühlmann Laboratories Ag Dispositif d'extraction , de dilution et de décharge d'un échantillon
FR3023614A1 (fr) * 2014-07-10 2016-01-15 Enterome Systeme de collecte d'echantillons de matiere fecale
DE102016004686A1 (de) * 2016-04-19 2017-10-19 KME Kern Medical Engineering GmbH Stuhlprobenaufnahmeset

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