WO2011144985A1

WO2011144985A1 - Pre-analytical medical device to collect a biological sample of feces

Info

Publication number: WO2011144985A1
Application number: PCT/IB2011/001058
Authority: WO
Inventors: Paolo Galiano
Original assignee: Alifax Holding Spa
Priority date: 2010-05-18
Filing date: 2011-05-17
Publication date: 2011-11-24
Also published as: IT1400004B1; ITUD20100096A1

Abstract

A pre-analytical medical device (10) to collect a biological sample of feces comprises a container (12) and at least a collection member (26) for the sample. The container (12) has inside a containing compartment (13) for the sample and is provided with an upper wall (14) having at least a first specialized aperture (16, 18, 20) with a shape and size mating with that of the collection member (26), for the introduction of the samples to be analyzed into the compartment (13). Said upper wall (14) also has at least a second specialized aperture (22), distinct from said first aperture (16, 18, 20), with a shape and size mating with that of a test tube (34) to transfer the sample outside the compartment (13) for subsequent analysis.

Description

"PRE-ANALYTICAL MEDICAL DEVICE TO COLLECT A BIOLOGICAL

SAMPLE OF FECES"

FIELD OF THE INVENTION

The present invention concerns a pre-analytical medical device of the disposable type, able both to collect and contain a biological sample of feces taken and to be analyzed, and also to dispose the sample for analysis.

BACKGROUND OF THE INVENTION

In the medical and veterinary field it is known that there is a need to take biological samples of feces from a patient, which will be subjected to one or more medical analyses. Usually, the sample is taken by the patient, at home or in a clinic, in the most disparate ways, depending on the type of sample, and inserted in a test tube. The test tube is closed with a stopper by the patient or a health worker and delivered to the laboratory. It is also known that, among the analyses that can generally be carried out, there is the verification of the presence of blood in the feces, or FOB ("fecal occult blood"). This test is recommended in the search for tumors of the colon. Another test that involves the collection and analysis of feces is the specific test for Helicobacter pylori.

The normal procedure provides to take a sample of feces, about 10 mg, by means of core sampling, repeated three times in three different points, with a single spatula or other collection member, having one end with collection loops.

Normally, the sample taken is inserted into a collection tube in which there is a device to limit the quantity that can be inserted, which standardizes the quantity of feces collected. At the end of this operation, the feces are normally dissolved in a solution that helps to detect the hemoglobin inside the collection tube. Subsequently, the dissolved feces are made to pass through a filter to eliminate the corpuscular part of the feces, in order to make an extract of the feces react with the appropriate anti-serums.

The sequential core sampling procedures, however, may not be very efficient, in order to show the possible presence of hemoglobin in the feces, since the sequential immersion of the spatula in the mass of feces supplies a poor collection of sample with hemoglobin, even though three immersions are made. In fact, already after the first immersion, the loops of the spatula could be saturated so that the other two immersions collect material only by scraping.

Another disadvantage is that the patient does not always respect the requirement to make three immersions or core samplings as recommended: if a higher number is made, this causes an excess of sample, which may give a false positivity on the test to be made.

Document WO-A-03/014705 describes a kit for the multiple collection of fecal matter for the purposes of laboratory analyses. The kit comprises three test tubes, each consisting of a tubular element having a closed bottom and an aperture into which a spatula is inserted which at the top has a closing element that cooperates with the upper aperture of the tubular element, and on the bottom a spatula element to collect the sample. The tubular element contains a preserving solution, into which the fecal matter is immersed after collection.

The kit described in WO-A-03/014705 also comprises a container for the concentration of the samples, having a closed truncated cone body on the bottom and an upper aperture to which a closing element is associated having three apertures sized to receive the test tubes. Inside the container a filtration chamber is provided comprising two sieves with different permeability. The user collects and inserts the three samples of fecal matter into the three respective test tubes and delivers them to the laboratory which opens them and inserts them, in an overturned position, into the three apertures of the container as above. The container is subjected to centrifugal force, forcing the fecal matter through the filtering chamber, until it is deposited onto the bottom of the truncated cone body where the material collected by the three test tubes is aggregated as a single quantity of filtered and concentrated material, forming a pellet which is examined. The solution described in WO-A-03/014705 does not allow a precise determination of the quantity of fecal matter taken and inserted into the concentration container. Furthermore, this solution needs a specially provided centrifuge apparatus to concentrate the filtered fecal matter on the bottom of the concentration container. Moreover, this solution does not supply a test tube containing the fecal matter already diluted and filtered and ready to carry out the test by immune-enzymatic or immune-turbidimetric methods with manual or automated methods, since the concentrated pellet must be taken from the container for the subsequent analyses. Document EP-A-1.366.715 describes an extraction test tube for the collection of fecal matter that comprises a hollow containing body into which it is possible to introduce a buffer solution and which is delimited at the lower part by a closing element. Furthermore, a pick-up element is provided that closes the hollow containing body at the upper part and which comprises a rod with loops for collecting the fecal matter. The hollow containing body has an intermediate dividing wall that has an aperture for the passage of the rod, at the same time with the function of retaining the excess fecal matter. The fecal matter is stirred to be dispersed in the buffer solution, the test tube is turned over and inserted in a housing of a machine for immunological analyses, the lower closing element, in this situation now facing upward, is removed to allow to pick up a portion of sample to be analyzed. This solution, however, does not allow to filter the fecal matter to be analyzed, which is particularly necessary to prevent interferences in turbidimetric analyses. Moreover, this solution also suffers from the disadvantage of sequential core samplings with a single pick-up member as discussed above, as well as not being an incentive for the patient to respect the desired sequence and standard number of samples.

Document EP-A-0.494.845 describes an analysis test tube for taking blood samples by means of vacuum suction, having a closing element made of perforatable rubber, which is used with collection devices of the double-needle type, where there is an external needle to insert into the patient's vein, and an internal needle to insert into the vacuum analysis test tube, after the rubber closing element has been perforated, so as to transfer the blood from the vein to the analysis test tube thanks to the vacuum suction effect of the analysis test tube. This solution, however, is not suitable, in particular with regard to filtration, for use in the collection of fecal matter which has morphological characteristics that are completely different from those of blood.

One purpose of the present invention is to achieve a pre-analytical medical device that overcomes the problems of collecting a small sample due to sequential core sampling and which increases the reliability and dependability of the analytical exams made on the biological sample contained therein, in particular the test for occult blood or the identification of Helicobacter pylori in feces. Another purpose is to achieve a medical device which is easy to use, used solely for the collection of the sample and separate from the test tube used for the test which, on the contrary, will be inserted into the manual or automatic instruments, in which the transfer into the test tube used for the test is guaranteed and reliable, whether performed by the patient or by specialized operators.

The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

SUMMARY OF THE INVENTION

The present invention is set forth and characterized in the independent claims, while the dependent claims describe other characteristics of the invention or variants to the main inventive idea.

In accordance with the above purposes, a pre-analytical medical device according to the present invention is used to collect a biological sample of feces, typically solid or semi-solid. In some forms of embodiment, the device according to the present invention is used to collect a sample of feces for the test for occult blood or the presence of Helicobacter pylori.

The device according to the present invention comprises a container that has inside it a compartment to contain the sample and which is provided with an upper wall.

The device according to the present invention comprises at least three collection members for the sample, distinct from each other, and at least three first specialized apertures, made on the upper wall and each having a shape and size mating with that of the collection members, for the sequential introduction of a correlated plurality of samples to be analyzed into the containing compartment. According to one feature of the present invention, the upper wall, in addition to the at least three first apertures dedicated to inserting the members for collecting the sample, also has at least a second specialized aperture, having a shape and size mating with that of a test tube, of the vacuum type, or the type in which the suction vacuum is created manually, to allow the test tube to be inserted into the containing compartment, so as to transfer the sample outside the containing compartment in order to effect the extraction of the sample of suitably filtered feces and then to carry out the subsequent analysis. According to the present invention, the second specialized aperture is associated at the lower part, advantageously in a coaxial direction, with a suction needle destined to cooperate with the vacuum test tube or the type in which the suction vacuum is created manually. The suction needle is connected to a filtering member located inside the containing compartment, so that the sample of diluted feces is filtered by the filtering member and is then transferred, through the suction needle, to the vacuum test tube, or "vacutainer", by suction.

In some forms of embodiment, the device according to the present invention comprises a connection member of the tubular type, disposed during use through the second aperture, having a first portion that protrudes during use from the upper wall of the container and into which the test tube is inserted, and a second portion that extends inside the compartment.

In variants of these forms of embodiment, the connection member has a tubular element disposed in the second portion, in which the filtering member is located. The tubular element has an aperture for the passage of the sample of feces, advantageously after a suitable liquefaction by means of the addition of extracting liquid, from the internal compartment toward the filtering member and then toward the test tube, so as to allow it to be removed from the container.

According to other forms of embodiment, at least one of the first apertures is provided with a standardization element conformed in correlation with the collection member and suitable to determine the introduction into the compartment of a desired portion of the sample collected by the collection member. This form of embodiment is advantageous, inasmuch as the standardization element is sized to limit and collimate the quantity of sample inserted, so as to satisfy to the requirements of the analytical protocol.

In some variant forms, the standardization element comprises a tubular element that extends from the second aperture toward the inside of the compartment into which the collection member is inserted. The tubular element of the standardization element has a lower portion with a section that narrows progressively toward the bottom so as to define a passage gap with a shape mating with that of the collection member.

In other forms of embodiment of the present invention, the upper wall also has at least a third specialized aperture, distinct from the at least three first apertures and also from the second aperture, through which a suitable extracting or diluent liquid can be introduced into the compartment, for example to dissolve the sample to be analyzed. The advantage of using a test tube for collecting the sample of feces without extracting liquid already inserted in the body of the test tube allows more flexibility in application to different tests, such as FOB or Helicobacter pylori, since different tests require specific extracting liquids.

In some forms of embodiment, each collection member has a gripping end and, in the opposite position, a pick-up end, connected by an oblong element or rod. The gripping end has a clamping body suitable to achieve a same-shape coupling with a corresponding one of the first apertures. In this way, the sample cannot be taken repeatedly by the patient or health worker using the same collection member already used.

A kit comprising a device as described above, and a test tube of the vacuum type, or the type in which a depression is created manually, also come within the spirit of the present invention.

Furthermore, the present invention also concerns a method for the collection of a biological sample of feces in a container that has inside it a containing compartment for the sample and provided with an upper wall.

Using at least three collection members for the sample, distinct from each other, the method provides to introduce in sequence at least three samples to be analyzed into the compartment through at least three first specialized apertures, made through the upper wall and each having shape and size mating with that of the collection members; to connect a test tube of the vacuum type, or in which the suction vacuum is created manually, to a second specialized aperture, distinct from the first apertures, made through the upper wall and sized so as to accommodate the test tube; and to determine a suction of the sample contained inside the compartment, transferring a desired quantity thereof into the test tube and, at the same time as said suction, to filter the sample that is transferred from the container to the test tube, before it enters into the test tube, by means of a filtering member located in the compartment, which cooperates with a suction needle associated with the test tube, so that the sample, filtered by the filtering member, is transferred through the suction needle into the test tube. Advantageously, the same test tube can be used directly, without further treatments and interventions by the operator or user, to perform the desired test by means of immune-enzymatic or immune-turbidimetric methods either manual or automated.

The present invention is particularly advantageous in the analysis of fecal samples to verify the presence of occult blood or Helicobacter pylori.

The use of a collection container that can be combined with the vacuum test tube used for the test gives a reduction in costs, simplification of the sample- taking, which can be carried out either by the patient or by the health worker, the opportunity to transfer the sample from the collection container to the test tube used for the test only at the moment of the test, since the collection container according to the present invention can easily be sent to the laboratory because it is not the test tube used for the test. These operations can be performed together by the patient and the laboratory technician, or separately, in different places and at different times. In particular, the filtration of the sample can be performed, if so desired, by the patient at the end of collection, or can be delayed and performed later by the laboratory technician. Furthermore, the test tube is filled using a traditional vacuum test tube, or with a test tube where the vacuum is created manually.

Since the test for occult blood or Helicobacter pylori is a mass screening test, and since the task of collecting the sample is normally given to the patient himself, according to approved procedures, the possibility of effecting the filtering step by the patient, using any vacuum test tube, allows the laboratory workers to receive a test tube already available to carry out the test by means of immune-enzymatic or immune-turbidimetric methods either manual or automated. From an economic point of view, it is also advantageous to use any vacuum test tube compared with dedicated test tubes which sometimes need specialized instrumentation able to squeeze, using pincers, the test tube for the collection of the sample in order to obtain diluted and filtered material before passing to the chemical or immune-enzymatic steps.

In some advantageous forms of embodiment, both the collection container of the device according to the present invention, and also the associated test tube, can be provided with bar codes to identify the patient, of the unrepeatable type, or RFID tags, in order to prevent errors of classification in the patient's sample. Moreover, with the present invention, providing a second autonomous aperture for the introduction of the extracting or diluent liquid, it is possible to select and introduce the specific liquid to perform different analyses separately, for example occult blood, or Helicobacter pylori, in this way personalizing the analysis to be made. This solution, with the second aperture dedicated to the introduction of the extracting or diluent liquid, provides the advantage that the final user or operator can introduce a precise and determinate quantity of liquid, possibly thanks to notches or other graduated or colored reference signals to indicate the quantity, provided on the container, even a short time before the analysis. In this way the problems of known containers are avoided, which are filled with extracting or diluent liquid during the production step and where the precise volumetric quantity cannot be guaranteed for the final user, due to erroneous filling, evaporation or other phenomena in which liquid is lost. And in fact, the possibility of pouring the liquid at the very moment of use reduces evaporation. Moreover, it is also advantageous to provide at least three collection members, generally conformed as spatulas or suchlike, because it guarantees greater reliability in the precision of the quantity of sample collected: since the spatula is irremovably constrained, there can be no erroneous repetitions on the part of the patient, and for every core sampling there is a real removal or collection of fecal matter, so as to perform the procedures suggested for the test. The present invention, since it provides three collection members, solves the problem of the known collection procedures where, always using the same collection member, after the first immersion the loops of the spatula are already saturated with the first sample, and do not contain a coherent sampling for the three core samplings even if effected in three distinct zones of the sample as the norms for the test require.

This is particularly advantageous in the configuration with three collection members which is suitable for the test for occult blood, which has a collection protocol that is internationally standardized, providing three distinct samples made by means of core sampling.

Furthermore, by carrying out a plurality of distinct immersions or core samplings, it is possible to take samples that significantly increase the percentage statistical probability of collecting samples with traces of hemoglobin in the feces. Core samplings with more than one collection member guarantee a sufficient and improved collection of sample containing hemoglobin compared with known procedures. The quantity collected with the present invention gives a better representation of the dispersion of the hemoglobin possibly present, compared with three sequential core samplings made with a single collection member, which already at the first core sampling saturate the loops, and do not supply a real and reliable dispersed quantity for the search to find hemoglobin.

Consequently, the collection procedure according to the present invention is different from the state of the art since it is performed with distinct collection members, in distinct positions of the sample to be analyzed, which are then introduced into the single container of the device according to the present invention.

According to variants of the invention, each of the collection members according to the present invention is also advantageously conformed and proportionate for a volumetric capacity suitable to collect a desired fraction of a sample, the sum of the fractions collected representing the overall quantity of sample to be collected according to the international standardized norms suggested.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other characteristics of the present invention will become apparent from the following description of a preferential form of embodiment, given as a non-restrictive example with reference to the attached drawings wherein:

- fig. 1 is a perspective view of a pre-analytical medical device for the collection of a biological sample of feces according to the present invention;

- fig. 2 is a perspective view of a container of the device in fig. 1 ;

- fig. 3 is a perspective view of a collection member of the device in fig. 1 ;

- fig. 4 is a perspective view of the device in fig. 1 in an operating condition;

- fig. 5 is a perspective view of the device in fig. 1 in an operating condition associated with a vacuum test tube;

- fig. 6 shows a section of the device in fig. 1 coupled with a vacuum test tube.

DETAILED DESCRIPTION OF A PREFERENTIAL FORM OF

EMBODIMENT

With reference to fig. 1, a pre-analytical medical device 10 according to the present invention is used for the collection of a biological sample of feces for the purposes of the test for occult blood (FOB). The sample of fecal matter, collected in the quantity prescribed by analytical protocols, is diluted in an appropriate liquid, filtered and transferred into a test tube, generally under vacuum, which functions as a cuvette for the analysis, and will be used directly in the test to identify any occult blood, typically by means of photometric analysis; otherwise, a portion will be taken from the test tube which in turn will be transferred into the analysis cuvette.

The medical device 10 comprises a container 12 which has inside it a compartment 13 into which the sample is introduced. The container 12 is for example cylindrical in shape and made of a suitable transparent plastic material. The container 12 is provided with an upper wall 14 which functions as a closure for the compartment 13, a lower wall 15 which defines the bottom and a lateral shell 17.

The upper wall 14 has a plurality of apertures 16, 18, 20, 22, 24 (figs. 1, 3 and 4) having different functions and specializations, as will be explained in more detail hereafter in the description.

In particular, first specialized apertures 16, 18, 20, at least three in number, have the function of allowing to insert, into each of them, a respective collection member or spatula 26 to collect the sample. The first apertures 16, 18, 20 have a shape and size mating with that of the collection member 26. Each collection member 26, in a traditional manner, has a gripping end 28 and, in an opposite position, a pick-up end 30, connected by an oblong element or rod 29.

Each pick-up end 30 is provided with a series of loops, cavities or other containing seatings 32, for example made as a threading on the terminal portion, in which, once the sample has been core sampled by means of an immersion of the collection end 30, the fecal matter is attached and retained.

Preferably, a standardization element 19 is associated with each of the apertures 16, 18 and 20, to limit and collimate the quantity of fecal matter taken, for example about 3.3 mg. In some forms of embodiment, the standardization element 19 is conformed as a tubular element 21 that extends from each aperture 16, 18 and 20 inside the compartment 13 and having a lower end 21a with a section that narrows progressively, in this case conformed as an upside-down truncated cone, like a funnel, so as to define a terminal passage gap 21b (fig. 3) having transverse form and size substantially mating with those of the pick-up end 30 of the collection member 26.

In this way, the insertion of the pick-up end 30, to the loops 32 of which the fecal matter is attached, causes the pick-up element 30 to slide in contact against the walls of the passage gap 21b, allowing to introduce into the compartment 13 only the desired quantity of sample that is actually contained in the loops 32. According to some forms of embodiment of the invention, the total collection volume of the loops 32, defined by their number, depth and reciprocal pitch, is commensurate with the necessary quantity of the sample to be standardized for the analysis.

According to some forms of embodiment of the present invention, the quantity that each collection member 26 is suitable to introduce into the compartment 13, due to the sizing of the relative loops 32 and the action to limit the quantity that is exerted by the standardization element, is equal to a fraction, in this case a third, of the quantity normally required by the specific analytical protocols for the test for occult blood. In this way, using one single time each of the three collection members 26, which are immersed in three different positions into the fecal matter, it is possible to introduce overall into the compartment 13 a quantity of sample equal to that required by the protocols.

Preferably, the gripping end 28 of the collection member 26 has a clamping body 28a (fig. 2), with a flared shape, for example like a truncated cone, by means of which a same-shape coupling can be made with the relative first aperture 16, 18 or 20, into which the collection member 26 is inserted. The same- shape coupling functions as an anti-repetition attachment, preventing any detachment of the collection member 26 once it has been introduced with the quantity of fecal sample taken. This guarantees that the sampling is not repeated by the patient or operator with the same collection member 26 already used, but using one of the remaining collection members 26, guaranteeing reliability and accuracy of the test.

The diameter of the first apertures 16, 18, 20 is for example about 3 cm, sufficiently wide to allow the collection members 26 to be manually inserted easily. A second specialized aperture 22 is used for coupling with a test tube 34 (figs. 5 and 6) of the vacuum type, or with a vacuum created manually, such as for example in the application for a patent of industrial invention UD2009A000228 filed on 15.12.2009 in the name of the present Applicant. The second specialized aperture 22, distinct from the first apertures 16, 18, 20, is mating in shape and size with that of the test tube 34, normally larger in size than that of the apertures 16, 18 and 20. In particular, located through the second aperture 22, a sleeve is provided, or equivalent collection member 36, hollow inside to allow the test tube 34 to be inserted.

Advantageously, as can be seen in fig. 6, the sleeve 36 is also made as a single piece with the upper wall 14, for example by means of a single molding operation of a suitable plastic material.

The sleeve 36 has a first portion 38, protruding toward the outside from the upper wall 14, and a second portion 40 that extends inside the compartment 13, substantially as far as in correspondence with the lower wall 15.

The second portion 40 has a bottom 42 from which a tubular element 44 extends toward the inside of the sleeve 36. The tubular element 44 is also hollow inside, in this case shaped like a raceway.

Preferably, as can be seen in fig. 6, the tubular element 44 is also in a single piece with the sleeve 36, for example made by the molding technique as above.

A filter 46 is located in the tubular element 44, and is normally used to filter the dissolved or diluted fecal matter. The filter 46 is for example made of paper, or other material with a porosity suitable for the sizes of the particles to be filtered, so as to allow only a selective passage of substances, filtering and holding the bodies and/or substances present in the biological sample that are not intended to take part in the analysis of the biological sample. The filter 46 allows to eliminate any disturbing material from the photometric measurement/reaction, both in optical terms, disturbances due to the alteration of the light radiation with scattering phenomena, and also in mechanical terms, with possible obstructions of the hydraulic path.

The tubular element 44 has an aperture 50, provided substantially in contact with the lower wall 15 of the container 12. In this way, by means of the aperture 50, the filter 46 located in the tubular element 44 is in fluid communication with the remaining part of the compartment 13.

On an upper portion 52 of the tubular element 44, in a position opposite the aperture 50, a suction needle 54 is provided, in normal use in a vertical position, communicating on one side with the inside of the tubular element 44, and on the other side suitable to hole and be inserted into the test tube 34, in particular to hole a cap 35 of the test tube 34. The suction needle 54 is then disposed below the second aperture 22, advantageously in a direction coaxial with the latter, inside the containing compartment 13 and above the filter 46 disposed in the tubular element 44, with which it communicates through the upper portion 52. In this way, the depression present, or created manually, inside the test tube 34 causes the liquid in which the fecal sample is dissolved to be drawn from inside the compartment 13 toward the inside of the test tube 34. The liquid is thus drawn through the aperture 50, forced through the filter 46 and finally, in the desired quantity, is sucked through the suction needle 54, directly into the test tube 34. From here, the sample is ready, in the necessary quantity and condition, to be subjected to the analysis required.

A third specialized aperture 24, distinct from the first apertures 16, 18, 20 and from the second aperture 22, is used to introduce a diluent or extracting liquid used to take the sample to the desired analysis conditions. For example, it is possible to use a concentration or dilution saline solution, a physiological solution, a culture broth, an anticoagulant, an extraction liquid, different according to the analysis requirements, or other substances known in the state of the art and suitable for the pre-analysis step of the biological sample, according to needs. For example, for the verification of the presence of occult blood, a specific extracting liquid is used for measuring the hemoglobin. For the verification of Helicobacter pylori, an extracting liquid suitable for the purpose can be used.

Advantageously, an introduction element 23 is associated with the third aperture 24, such as a funnel, a sleeve or other, which surrounds the third aperture 24 and extends outside the upper wall 14. Advantageously, the introduction element 23 also has a closing member or stopper 25 connected to it by means of a flexible tongue 27. The closing member 25 has a conformation mating with that of the introduction element 23, and can be rotated and inserted into the latter, allowing a substantially hermetic seal of the whole.

Preferably, the introduction element 23 and the relative closing member 25 are also made in a single piece with the upper wall 14, for example by means of a single molding operation of a suitable plastic material.

The device 10 is used as follows. Each collection member 26 is immersed in different points of the fecal mass, so as to have a good distribution of the presence of hemoglobin. Each collection member 26 is inserted, as shown by the arrow F in fig. 1, and constrained to the relative first aperture 16, 18 or 20, having a collimation effect of the quantity of sample thanks to the standardization element 19.

Subsequently, the desired extracting liquid is introduced through the third aperture 24, which is closed, as indicated by the arrow M in fig. 4, by the closing member 25. This step is totally innovative compared with known containers which contain the extracting liquid from the very beginning and, for this very reason, do not guarantee a sure volume of extracting liquid (due to evaporation, erroneous dosage or other). The step is performed by the patient or by the health worker, who can calibrate the precise quantity of liquid thanks to suitable notches or signs provided on the lateral shell 17 of the container 12.

Subsequently, as indicated by the arrow G in fig. 5, the test tube 34 is coupled with the container 12, inserting it into the sleeve 36, so that the suction needle 54 perforates the cap 35, causing the sample diluted in the liquid to be sucked in as indicated by the arrow L in fig. 6, through the filter 46 and from here into the test tube 34, in the quantity and conditions as laid down by the protocols for the analysis.

Claims

1. Pre-analytical medical device to collect a biological sample of feces, comprising a container (12) that has an internal compartment (13) to contain the sample and provided with an upper wall (14), said device comprising at least three collection members (26) for the sample, distinct from each other, and at least three first specialized apertures (16, 18, 20) made on said upper wall (14) and each with a shape and size mating with that of said collection members (26), for the sequential introduction of a correlated plurality of samples to be analyzed into the compartment (13), characterized in that said upper wall (14) also has at least a second specialized aperture (22), distinct from said first apertures (16, 18, 20), with a shape and size mating with that of a test tube (34) of the vacuum type, or the type in which the suction vacuum is created manually, to transfer the sample outside the compartment (13) for subsequent analysis, said second aperture (22) being associated at the lower part with a suction needle (54) intended to cooperate with the test tube (34), said suction needle (54) being connected to a filtering member (46) located inside said compartment (13), so that the sample, filtered by the filtering member (46), is transferred through said suction needle (54) into said test tube (34) by means of suction.

2. Device as in claim 1, characterized in that it comprises a connection member (36) of the tubular type, disposed, during use, through said second aperture (22), having a first portion (38) which protrudes, during use, from the upper wall (14) and in which the test tube (34) is inserted, and a second portion (40) which extends inside the compartment (13).

3. Device as in claim 2, characterized in that said at least one connection member (36) has a tubular element (52) disposed in said second portion (40), in which said filtering member (46) is located, said tubular element (52) having an aperture (50) for the passage of the sample to be analyzed from the internal compartment (13) toward the filtering member (46).

4. Device as in any claim hereinbefore, characterized in that at least one of said first apertures (16, 18, 20) is provided with a standardization element (19) conformed in correlation to the corresponding collection member (26) and suitable to determine the introduction into the compartment (13) of a desired portion of the sample collected by the collection member (26).

5. Device as in claim 4, characterized in that said standardization element (19) comprises a tubular element (21) which extends from said at least one first aperture (16, 18, 20) toward the inside of the compartment (13) and in which the collection member (26) is inserted, the tubular element (21) having a lower portion (21 a) with a section progressively narrowing downward so as to define a passage gap (21b) with a shape mating with that of the collection member (26).

6. Device as in any claim hereinbefore, characterized in that said upper wall (14) also has at least a third specialized aperture (24), distinct at least from said first aperture (16, 18, 20), through which a suitable extracting or diluting liquid is introduced into the compartment (13).

7. Device as in any claim hereinbefore, characterized in that each collection member (26) has a gripping end (28) and, in the opposite position, a pick-up end (30), connected by an oblong element or rod (29), said gripping element having a clamping body (28a) suitable to achieve a same-shape coupling with a corresponding one of said first apertures (16, 18 or 20).

8. Kit comprising a device as in any claim hereinbefore and a test tube (34) of the vacuum type, or of the type in which the suction vacuum is created manually.

9. Method to collect a biological sample of feces in a container (12), that has an internal compartment (13) to contain the sample, and provided with an upper wall (14), characterized in that it provides, using at least three collection members (26) for the sample, distinct from each other, to introduce in sequence a plurality of samples to be analyzed into said compartment (13) through at least three first specialized apertures (16, 18, 20), made through said upper wall (14) and each of a shape and size mating with that of said collection member (26), to connect a test tube (34) of the vacuum type, or the type in which the suction vacuum is created manually, to a second specialized aperture (22), distinct from said first apertures (16, 18, 20), made through said upper wall (14) and sized so as to accommodate said test tube (34), and to determine a suction of the sample contained inside the compartment (13), transferring a desired quantity thereof into the test tube (34), and, simultaneously with said suction, to filter the sample that is transferred from the container (12) to the test tube (34), before it enters into said test tube (34), by means of a filtering member (46) located in the compartment (13), which cooperates with a suction needle (54) associated with the test tube (34), so that the sample, filtered by the filtering member (46), is transferred through said suction needle (54) into said test tube (34).