WO2024127437A1

WO2024127437A1 - Collection device and method for the transport and processing of biological samples in a totally sterile supply chain

Info

Publication number: WO2024127437A1
Application number: PCT/IT2023/050270
Authority: WO
Inventors: Lorenzo Drago; Carlo Luca ROMANÒ; Marco MIGLIORI
Original assignee: Nova Health S.R.L.
Priority date: 2022-12-13
Filing date: 2023-12-04
Publication date: 2024-06-20

Abstract

Device (1 ) for medical-surgical use for the collection of biological samples or the like to be analyzed, which has at least one collection compartment (2) provided with a hermetically closable opening, intended to contain said biological samples or the like to be analyzed; at least one containment chamber (3) comprising at least one container (4), in turn containing a lyophilized and/or liquid product for the chemical detachment of bacteria and/or the desegregation of microbial biofilm from said biological samples or the like to be analyzed, and a solvent of said lyophilized and/or liquid product, wherein said containment chamber (3) is selectively communicating with said collection compartment (2); and wherein said at least one container (4) is configured to selectively open and dissolve said lyophilized and/or liquid product in said solvent. The present invention also concerns a method and a kit for the collection, transport and processing of biological samples or the like, using said device (1 ).

Description

Collection device and method for the transport and processing of biological samples in a totally sterile supply chain *****

The present invention concerns a collection device and method for the transport and processing of biological samples in a sterile supply chain, in particular a bag and a vehicle system for the biological material to be processed, hermetically closed and free from external contamination, for collection and transport of explanted samples and biological and non-biological materials for chemical-clinical and microbiological analyses.

A device and method of treatment in a sterile supply chain is also disclosed, in particular a test tube for laboratory applications in the clinical and biological field and a processing method associated with it.

Field of invention

More in detail, the invention concerns a sterile device for medical-surgical use suitable for the collection and transport from the surgical/ambulatory room to a clinical and microbiological analysis laboratory of biological samples (biological liquids, tissues, organs and portions thereof) and/or implantable or prosthetic materials explanted during surgical operations such as, by way of example but not limited to, joint prostheses or their parts or components, metal plates, metal wires, cerclages, screws, nails, bone cement, bone substitutes, catheters, heart valves, breast prostheses, urological prostheses, neurosurgical prostheses and osteosynthesis materials, dental or maxillofacial prostheses, etc., in such a way as to completely protect them from bacterial contamination.

The present invention can have, in addition to those mentioned, various applications in the laboratory and in the clinical field, comprising the preparation of PRP (Platelet-Rich Plasma) in the human and veterinary field, to the various forms of collection of pellets, supernatants, and intermediates in fields ranging from microbiology to biochemistry, to hematology; biopsies in microbiology and oncology and in all branches of medicine, in which biological and non-biological solutions are used, for medical devices or liquid dispensers, or collection systems that require centrifugation, comprising urine, respiratory materials, blood, synovial fluids, exudates, and pus, or liquid or semi-liquid biological materials, etc., which require a closed system for transport and processing.

In the following, the description will be aimed at the collection and transport of explanted biological samples for clinical and microbiological analyses, but it is clear that it should not be considered limited to this specific use.

According to another aspect, a test tube is provided designed, and manufactured in particular for medical-surgical and laboratory use in general, suitable for the conservation and analysis of fluids, homogenated tissues, cellular components, etc., obtained from samples collected and sent to a chemical-clinical and/or microbiological analysis laboratory. Such collected samples can be biological samples, for example, biological liquids, tissues, cellular extracts and their portions, organs and their portions, or liquids taken from solutions in which implantable or explanted prosthetic materials, synthesis media, cements, amalgams, morcels, suture threads, during surgical operations, in such a way as to protect them from bacterial contamination. The device of the mentioned type can be used to process samples in solution or suspension, regardless of the collection method and for which chemical, clinical, and microbiological analysis is required. In the following, the description will focus on the test tube for processing biological samples but it is clear that it should not be considered limited to this specific use.

Prior art

As is well known, prosthetic components, biological samples, and/or similar, collected in the surgical room for analysis, are subject to contamination by bacterial agents.

Furthermore, as it is known, even the transport and processing prior to the analysis of such biological and/or similar samples are subject to contamination, which can interfere with the analysis of the samples themselves, limiting their sensitivity and specificity.

Currently, the sensitivity and reproducibility of an in vitro analysis starting from biopsy material can be significantly reduced by the presence of contaminating agents, which comprise, but are not limited to biofilms, microorganisms, bacteria. Furthermore, antibiotic treatments previously applied, for example, to the subjects from whom these samples were taken, are a source of error for the analysis.

Although these factors cannot be excluded from the analysis, it is essential to exclude or at least reduce errors caused at the time of sampling, or the collection, transport, and processing of said samples and/or similar ones to be analyzed, in order to avoid incorrect diagnoses, definition of an unsuitable treatment and, consequently, undesired side effects. It seems clear that an incorrect diagnosis of an infection related to an implant, or one obtained in an excessively long time, entails an unsustainable social and financial impact, as well as exorbitant medical-legal risks and costs.

As is known, various procedures are known to extract bacteria from prostheses, mainly with physical or chemical action.

A first physically acting process is known as sonication and uses a mechanical instrument to remove bacteria from implants or prostheses. This system has proven effective in increasing the percentage of isolation of microorganisms when they are immersed and surrounded by biofilm and strongly adhered to prosthetic material.

However, this technology does not find application in biopsy material, liquid, or prosthetic materials that comprise polymethyl methacrylate or cements, especially if impregnated with antibiotics.

Furthermore, sonication requires long application times, and high costs, as well as specially trained and dedicated personnel (human cost). These limits imply its use only in a small number of hospital centers.

As is well known, there are chemical detachment systems based on thiols, for example, dithiothreitol, of bacteria present in prosthetic implants and in biological samples obtained from biopsies by in vitro culture. This technique has a low cost and is simple to use.

Relevant prior art also includes patent applications WO 96/14570 A1 and US 2017/136454 A1.

However, the storage of the chemical agent, prior to its use, is limited due to potential oxidation.

Therefore, the need for a system and/or method to increase the durability of the chemical agent before its use appears evident.

It is also known that test tubes are purely tubular-shaped devices intended for containing samples of various kinds, such as blood, urine, sputum, and solutions containing other samples to be analyzed in analysis and microbiology laboratories.

As is known, test tubes are currently on the market which have two internal dip tubes of different lengths.

Generally, tubes are made of materials that allow samples to be processed inside the tubes themselves. Commonly used materials include borosilicate glass (pyrex) or plastic material, such as PET. These materials allow the tubes to be inserted directly into a centrifuge in such a way as to facilitate the separation of the sample components, in particular the supernatant and precipitate.

A shorter-length dip tube is used to draw, or collect, the supernatant of the sample, while the longer-length dip tube is used to recover the sample to be analyzed, which has precipitated in the lower part of the test tube or pellet.

Therefore, it is known that following the centrifuge, the shorter draft tube is used to eliminate the suspended part, generally not of interest for the analysis, and the longer draft tube is used to recover the precipitate.

It is also known that since the density of the precipitate is often high, the drawing capacity from the bottom of the test tube is limited.

Furthermore, the precipitate is often very viscous or agglomerated, especially when subjected to centrifugal force, causing further difficulty in recovering the precipitate itself.

It is estimated that approximately 30% of the precipitate remains trapped inside the suction tube or inside the test tube due to obstruction of the tube itself.

It is therefore clear that there is a need to provide a device capable of facilitating the recovery of the precipitate, reducing the quantity of the same, which remains trapped in the suction tube used for its recovery.

Scope of the invention

In light of the above, it is, therefore, the scope of the present invention to reduce exogenous and endogenous contamination of the biological and/or similar samples to be analyzed during their collection.

Another scope of the invention is to reduce the contamination of biological and/or similar samples to be analyzed during transport from the surgical room to the analysis center and their processing.

Another scope of the invention is to guarantee the isolation of pathogenic microorganisms, dissolving and eliminating the biofilm, favoring their detachment or disintegration from the biological material, so as to facilitate their discovery and subsequent identification, and faithfully reproduce the actual microbial ecosystem responsible for infection in the sample taken.

A further purpose of the present invention is to provide the tools necessary for carrying out the method and the apparatus that carries out this method.

According to another aspect, a test tube is provided capable of extracting the precipitate to be analyzed, preventing the risk of contaminating the sample and with a low-cost and easy-to-use solution.

A method of operation of said tube for the collection of a sample and the extraction of the precipitate and/or the collection of the supernatant to be analyzed is also provided.

The tools necessary to carry out the method and the equipment that carries out this method are also provided.

Object of the invention

These and other results are obtained according to the invention with a device, which can be closed sterilely and hermetically, for medical-surgical use for the collection, transport, and processing of biological or similar samples to be analyzed.

The specific object of the present invention is therefore a device for medical- surgical use for the collection of biological or similar samples for analysis.

The device comprises at least one collection compartment and at least one containment chamber.

The collection compartment is provided with a hermetically closable opening, intended for the containment of said biological samples or the like to be analyzed.

Said containment chamber comprises at least one container, containing, in turn, a freeze-dried and/or liquid product for the chemical detachment of bacteria and/or microbial biofilm from said biological or similar samples to be analyzed.

Said containment chamber also comprises a solvent for dissolving said freeze-dried and/or liquid product.

Furthermore, said containment chamber is selectively communicating with the collection compartment, and said at least one container is configured to selectively open and dissolve said freeze-dried and/or liquid product in said solvent.

Still, according to the invention, a device can comprise a compressible containment chamber such that, when said containment chamber is compressed, said at least one container opens to dissolve said freeze-dried product in said solvent.

Preferably according to the invention, said lyophilized product may comprise lyophilized dithiothreitol (DTT) and/or N-acetylcysteine and/or glutathione, mercaptoethanesulfonate (MESNA) or other solutions capable of dissolving the biofilm and microbial aggregates.

Further according to the invention, said containment chamber may comprise a reagent capable of combining with said freeze-dried product to produce a liquid that can be used for the chemical detachment of bacteria and/or microbial biofilm from said biological samples and the like to be analyzed.

Still according to the invention, said collection compartment can be made of soft and/or compressible material.

Again according to the invention, said containment chamber may be communicating with said collection compartment so that said freeze-dried product, when in solution, can be conveyed from said containment chamber to said collection compartment for the chemical detachment of bacteria from said samples biological and the like to be analyzed.

Preferably according to the invention, said at least one container can be a bottle configured to open by breaking.

Still according to the invention, said containment chamber may comprise a valve to selectively communicate with said collection compartment.

Furthermore, said device may comprise an extraction means, wherein said collection compartment comprises a valve for selectively communicating with said extraction means.

Furthermore, it is specific object of the present invention a method of collection, transport and processing of biological samples or the like by means of a device for the collection, transport, and processing of biological samples or the like, which comprises the following steps: opening said device and positioning, at within said collection compartment, the samples to be stored, transported and/or analyzed; hermetically close said device; compressing a portion of said containment chamber to open said at least one container; dissolving a freeze-dried product contained in said at least one container in a solvent contained in said containment chamber; connecting the containment chamber with the collection compartment.

Preferably according to the invention, said method may also comprise the following steps: opening a valve to connect said collection compartment with said extraction means; and withdrawing a fraction of the solution containing said samplecontaining liquids or the like from the collection compartment.

Further, the step of closing the device may comprise removing the air from said collection compartment when the sample has been collected.

The specific object of the present invention is therefore a device as defined in claim 1 .

Preferred embodiments are defined in the dependent claims. According to another aspect, a device is provided, in particular a test tube, for medical-surgical use for the analysis of biological samples or the like. Said device comprises a containment casing for containing a sample to be analyzed in solution or in suspension, which extends predominantly along an said lower base for extracting said sample from said containment casing.

The test tube, preferably, may allow extraction while avoiding contamination from agents external to the device itself.

The test tube may comprise a separation means for selectively separating said sample from an internal wall of said casing and for extracting said sample through said outlet channel.

Said test tube may comprise a valve configured to prevent the accidental leakage of said sample through said channel.

Said valve can be placed in contact with said outlet channel, and be selfoccluding so as to allow the sample to flow out in a controlled manner and to avoid accidental leakage of said sample.

Preferably said separation means comprises a glass sphere.

Said test tube may comprise a suction and filling tube configured to withdraw and/or insert said sample in solution or suspension, having a proximal end and a distal end, in which said proximal end is in contact with said upper base of said containment casing and said distal end is arranged inside said containment envelope, configured to be immersed in said sample in suspension or in solution, and a sampling and filling port connected to said proximal end of said draft tube.

Advantageously, the test tube is suitable for the analysis of biological samples or the like in solution which has a supernatant portion and a precipitate portion, in which said draft tube can withdraw said supernatant portion, and said outlet channel can allow the extraction of said precipitated portion.

Said test tube can comprise a duct arranged in contact with said upper base and configured for air extraction.

Said output channel can be configured to couple to a syringe or a holder to take the sample.

Said outlet channel may comprise a narrowing of the internal walls.

This withdrawal and filling port can be configured to connect with a syringe and/or with a luer-lock system.

According to a further aspect, an operating method of a device, in particular a test tube, for medical-surgical use for the analysis of biological or similar samples to be analyzed, comprises the following steps of collecting, in a test tube as described above, a solution containing a sample to be analyzed, processing said solution containing the sample collected aseptically, and extracting, from said test tube, the sample contained in said processed solution. This method can avoid contamination from the external environment as the test tube separates the solution or suspension containing the sample from the external environment.

Advantageously, said step of processing said solution may comprise processing said solution to create a multiphase system, containing a supernatant portion and a precipitated portion; and said step of extracting the sample may comprise the step of selectively extracting said precipitated portion and/or taking said supernatant portion.

Said method may comprise operating a separation means to separate from the walls and selectively extract said sample to be analyzed deposited on the walls of said casing.

Said method may comprise extracting air from said test tube via a duct and/or withdrawing said supernatant portion via a withdrawal and filling port of said supernatant portion.

Brief description of the figures

The present invention will be now described, for illustrative but not limitative purposes, according to its preferred embodiments, with particular reference to the figures of the enclosed drawings, wherein: figure 1 shows a closed collection device for transport and processing in a sterile supply chain; figure 2 shows a biological sample collection compartment; figure 3 shows a system comprising the device shown in figure 1 and a container connected to it; figure 4 shows the device of figure 1 , which comprises a collection compartment and a containment chamber, which are in communication; figure 5 shows a closed circuit sampling system, which can be connected to the collection compartment, for the extraction of the liquids present there; figure 6 shows, in section and assembled, an embodiment of a test tube, which can be connected to a collection device, object of the present invention; figure 7 shows, in section and exploded view, an embodiment of a test tube that can be connected to a collection device, object of the present invention; and figure 8 shows, in section, an embodiment of the test tube in figure 6.

Detailed description

In the various figures the similar parts will be indicated with the same numerical references.

Referring to figure 1 , the device 1 essentially comprises a collection compartment 2 and a containment chamber 3.

Said containment chamber 3 contains, inside it, a solvent and a container 4 intended to contain, in turn, a freeze-dried product to be selectively combined with said solvent.

The device is preferably a sterile, hermetically resealable bag for medical- surgical use suitable for the collection and transport of biological samples from the surgical room to a clinical and microbiological analysis laboratory.

In some embodiments, the device 1 preferably has a structure made of polyvinyl chloride (PVC), which is a resistant, non-puncturable, and heat-sealable material.

In some embodiments, the device 1 is essentially a preferably transparent bag, made of polyethylene or polypropylene.

The collection compartment 2 has a hermetically closable opening 21 and is intended for containing biological or similar samples to be analyzed.

Said closable opening 21 can comprise a pressure-closable zip, for example, mini-grip®, zip, safety closing clamp, or a closure by applying vacuum.

Referring again to figure 1 , the collection compartment 2 can comprise a solution extraction system for collecting the sample to be analyzed.

In particular, said extraction system can comprise a filter 24 to facilitate, for example, the extraction of liquid from the collection compartment 2 to be transferred to test tubes, for example, a test tube 93, as described below, an extraction means 6 and a valve, to connect said extraction means and said collection compartment 2.

In some embodiments, the collection compartment 2 can include a one-way filter 24 to facilitate the passage of material from the collection compartment 2 to the extraction means 6, and at the same time to avoid contamination from said extraction means to the collection compartment 2.

In some embodiments, the device 1 can comprise said extraction means 6, to extract the liquid from the collection compartment and transport it, for example, to one or more dedicated test tubes for collection and analysis, which can allow, after centrifugation, the collection of the supernatant and the pellet deposited on the bottom of said one or more test tubes.

In some embodiments, said extraction means 6 can be included in said device 1 to obtain a closed circuit and avoid contamination.

In some embodiments, the collection of the supernatant and the pellet can take place via at least one specific connection, present on one or more tubes.

The containment chamber 3, always referring to figure 1 , is a portion of the collection compartment 2.

In some embodiments, the containment chamber 3 is electro-welded with the collection compartment 2.

Furthermore, the containment chamber 3 can include, as can be seen from figures 1 , 3, and 4, a valve 5 to selectively connect said containment chamber 3 and said collection compartment 2.

Said valve 5 can include a stem 51 configured to be broken, preferably as a result of compression of the containment chamber 3.

Consequently, breaking the stem 51 can put the containment chamber 3 in communication with the collection compartment 2, so that the sample collected in the device 1 is wetted by the solution, in which the freeze-dried product has previously dissolved.

In some embodiments, the valve 5 can comprise a cap, for example, which can be coupled to a thread, which allows the selective opening of the valve also from outside the containment chamber 3.

In this way, manipulation of the solvent and/or solute (freeze-dried product) is avoided.

The containment chamber 3 is configured to contain a freeze-dried product and a solvent to make said freeze-dried product liquid when necessary, i.e. , when it is necessary to preserve the biological samples to be collected, transported, and analyzed.

In particular, to prevent the freeze-dried product from coming into contact with the solvent before necessary, the freeze-dried product is contained in a container, for example, a bottle, a vial, or similar which separates the freeze-dried product from the environment surrounding it.

The numerical reference 4 indicates said container containing a freeze-dried product.

Referring to figure 1 , the container 4 is a polypropylene bottle.

The polypropylene bottle is preferably a bottle that can contain different quantities, for example, 50, 100, or 150 micrograms (pg) of rigid, lyophilized product, the opening of which occurs by twisting at the break.

Based on the size of the collection compartment 2, the quantity of freeze- dried product inside the container 4 can vary depending on the solution to be prepared. The 50 pg bottles can be rigid, having a twist opening system or a screw cap.

In fact, for devices having a containment chamber 3 with a volume of 50 ml, in the container 4 there may be 50 pg of freeze-dried product, while for a containment chamber 3 with a volume of 100 ml, in the container 4 there will be, for example, 100 pg of freeze-dried product and 150 pg in the bag having a containment chamber 3 with a volume of 150 ml.

In some embodiments, the bottles may contain an amount greater than 50 pg, for example, 75 pg, 100 pg, 200 pg, or 500 pg, for which closure may be ensured by rubber stoppers and/or sealed with external tamper-proof screw caps.

In alternative embodiments, one or more containers 4 may be present, for example, several propylene bottles containing a quantity of freeze-dried product equal to 50 pg each. In these embodiments, the number of containers 4 can vary depending on the volume of the containment chamber 3.

The container 4 can contain the lyophilized product, in the form of a powder to be dissolved in a solvent, in solid form, or in liquid form, and can include dithiothreitol (DTT), N-acecysteine, glutathione, MESNA, or any other solution capable of dissolve the biofilm and/or promote microbial detachment and/or isolation in a faithful and real way.

Further solutions capable of dissolving the biofilm and/or promoting microbial detachment and/or isolation include organic and inorganic chemicals with reducing activity, microbial, bacterial, or fungal extracts, and peptides having antibiofilm activity.

Furthermore, additional antibiofilm substances can be used such as bacterial peptidases, for example, serratio or pseudomonas peptidases, enzymes of various nature, such as, for example, proteases, amylases, lithiases, DNAses, glucosidases.

In some embodiments, the containment chamber 3 can include a plurality of containers 4 each containing a product capable of dissolving the biofilm and/or promoting microbial detachment and/or isolation.

The device 1 can also include an opening 22 to introduce the solvent inside the containment chamber 3.

Referring to figure 3, the device 1 may further comprise an additional container 8, which may be electro-welded, glued, or joined in a similar manner, with the collection compartment 2 and/or the containment chamber 3.

The additional container 8 can be used to report (writing, for example, using laser technique) the operating instructions to be carried out and/or a date by which using the device 1 or the freeze-dried product contained inside it.

The additional container 8 can also be configured to contain the devices for extracting and collecting the liquid to be analyzed (eluate) from the device 1 .

Referring again to figure 3, said additional container 8 joins the collection compartment 2 and/or the containment chamber 3 by means of a joining line 23 and a rhomboidal seal to join this container to the device 1 which includes it.

As can be seen from figure 3, the device 1 can include a fastening element 7, for example, a clamp, to hermetically close the collection compartment 2 and to reduce the movement of the biological samples collected inside said compartment.

Said fastening element 7 can include one or more hooking teeth 71 for fixing the fastening element 7 around the device.

Referring to figure 4, the device of figure 1 is shown, but in a different operational phase. In fact, as can be seen from figure 1 , the inside of the containment chamber 3 is isolated from the collection compartment 2, and the inside of the container 4 is isolated from the same containment chamber 3. From figure 4, however, it can be seen that the container 4 is open, therefore the freeze-dried product, contained inside the container, can come into contact with the solution present in the containment chamber 3.

Furthermore, from figure 4, it can be seen that the valve 5 is also open, therefore said containment chamber 3 is also in contact with said collection compartment 2. Furthermore, since the device 1 , before use, can be stored on a shelf or in a warehouse, a further closed conservation bag can contain the device, preventing external contamination before its use.

The operation of the device 1 described above is as follows.

When a biopsy, a surgical harvest, a removal of a limb or a prosthesis have been completed, it is necessary to preserve the samples of such surgical operations and collect said explanted samples to be able to transport them, using said device 1 , hermetically closed and sterile, to a laboratory where they can be analyzed.

Subsequently, said explanted samples (biomaterials and/or biopsy/biological samples) are inserted into the collection compartment 2, which must be hermetically closed.

In particular, the hinge 21 is opened, the sample is inserted inside it, and the hinge can be closed again.

The closure can be guaranteed by the hinge 21 , by the clamp 7, or by the combination of the two.

In some examples, to open the hinge 21 it is necessary to hold two edges of the device 1 , for example, with both hands, and perform a movement of the two edges along the direction of the closing axis, in which said hinge 21 extends in such a way by pushing one of the two flaps in one direction and the other flap in the opposite direction.

In some embodiments containing an external storage bag, before opening the hinge 21 , said storage bag can be opened by an operator.

Device 1 can be safely transported to the laboratory. In fact, the risk of contamination for the samples or for the operator can be minimized by the presence of a closed circuit for the transport and processing of the samples.

At this point, the containment chamber 3 can be compressed from the outside, in such a way as to open the container 4 inside it and allow the freeze-dried product contained therein to escape.

The opening of the container 4 can be caused by the breakage, for example, by twisting of one end of the container 4.

Once the freeze-dried product comes into contact and dissolves in the solvent of the containment chamber 3, said containment chamber 3 and/or said device 1 can be compressed or folded, so as to put the containment chamber 3 and the compartment collection 2 in communication, for example, by breaking valve 5. Furthermore, it is possible to further press the containment chamber 3 to allow the exit of the solution obtained, for example, containing DTT, N- acetylcysteine, or glutathione, MESNA, towards the collection compartment 2.

Once the samples have been collected, they are transported in sterile and safe conditions.

Referring to figures 1 and 5, the liquid (eluate) present in the collection compartment 2 can, therefore, be transferred by tapping or extraction. In particular, the transfer takes place through a closed circuit system that includes the connector 6, which is connected to a connector 91 , in turn in connection with a syringe 94, through which the extraction of the liquid takes place that, further, is transferred to the tube 93.

In some embodiments, a plurality of test tubes 93 may be present, depending on the size of the bag and the quantity of eluate to be extracted.

In some embodiments that provide for the presence of an extraction valve, it is possible to open said extraction valve, for example, frangible, to connect the collection compartment 2 with the extraction means 6.

Furthermore, referring to figure 5, it is possible to withdraw the liquid, or other material to be processed, for example, through a syringe 94 connected to the extraction means 6 by means of a connector 91 and/or a connection tube 95, and transfer it into one or more 93 tubes dedicated for processing.

Transfer to tube 93 occurs via a transfer duct 96.

The transfer duct 96 may include a transfer clamp 92 for selective switching from the syringe 94 to the tube 93.

When the sample is extracted from the device 1 and is transferred to the test tube 93, said transfer clamp 92 can be opened.

Once the transfer has been completed, said transfer clamp 92 can be closed to allow said test tube 93 to be disconnected from the device 1 and, therefore, processed, for example centrifuged.

In some embodiments, one or more test tubes 93 can comprise an access 932, for example, arranged on an upper end of said test tube 93, connectable to a syringe with a luer-lock system.

Therefore, it is possible to connect a syringe with a luer-lock system to the access 932 of the test tube 93, for example, to withdraw the supernatant from said test tube. Inside the test tube 93, as can be seen from figure 6, there may be a glass sphere 9306 placed near the lower base, for the removal by oscillation of the parts of pellets, which during the separation process have aggregated to the walls of the test tube 93.

In some embodiments, one or more test tubes 93 can include an access 934, which thanks to an automatic or safety closure, allows connection without the use of needles, for example, arranged on a lower end of said test tube 93, connectable to a syringe with luer-lock system.

Therefore, it is possible to connect a syringe with a luer-lock system to the access 934 of the test tube 93, for example, to withdraw the pellet from said test tube 93 or alternatively use a protection jacket 99 for connection to the test tube to perform a vacuum sampling.

Referring to figure 6, a test tube 93 for medical-surgical use for the analysis of biological samples or similar is shown.

The tube 93 is configured to collect biological samples to be processed, for example, by treatment with a centrifuge, and to facilitate the collection of at least a part of the sample.

In a preferred embodiment, the test tube 93 is configured for the collection and treatment of biological samples or the like. Nonetheless, this tube can be used for other types of samples, for example, for the collection and treatment of samples extracted from corpses or for waste water analysis.

Said test tube 93 substantially includes a containment casing 9301 to contain a sample to be analyzed in solution.

Said containment casing 9301 includes a surface that extends predominantly along an X axis, an upper base 9311 , and a lower base 9312.

In a preferred embodiment, the tube 93 may essentially be a tube where the containment casing 9301 is a cylinder, the side surface may be greater than the upper base surface 9311 and greater than the lower base surface 9312.

In some embodiments, said side surface may be much larger than the base surfaces.

According to some embodiments, the lower base 9312 can include a part that is removable from the test tube 93, substantially perpendicular to said X axis, to serve as a support base for the test tube 93 on a flat surface and which can be removed if necessary favoring the operations, for example, of extracting the precipitate from the test tube 93 itself.

The test tube 93 also comprises an outlet channel 9309 in contact with said lower base 9312 for sample extraction.

The outlet channel 9309 essentially comprises a sample outlet hole located at the bottom of the tube.

In particular, said outlet channel 9309 is configured to facilitate the exit of sediments, or precipitates, formed following a sedimentation process, which results in the separation from a liquid of solid particles suspended in it (supernatant), due to gravity or other forces, for example, centrifugal and/or electrical forces, resulting in the formation of a deposit or sediment or pellet.

The numerical reference 9302 indicates the portion of liquid in which the supernatant is suspended.

The numerical reference 9305 indicates the portion of the precipitate.

The presence of the outlet channel 9309, unlike what happens with existing state-of-the-art devices that use precipitate suction systems, in which a dip tube introduced from above with a length equal to the length of the test tube, favors a more efficient release of the precipitate.

In fact, since the outlet channel 9309 is in contact with the lower base 9312, it allows the precipitate to escape downstream of the test tube, for example, by gravity.

Furthermore, in some embodiments, the outlet channel 9309 may pass through the lower base and facilitate the connection of the tube 93 with a collection instrument, for example, a syringe or a holder 99.

In some embodiments, the outlet channel 9309 may have a first conical portion, in which the oblique walls 9307 may cause a determined narrowing of the surface of the outlet channel 9309, and a second cylindrical portion.

Referring to figure 6, said oblique walls 9307 extend from a portion of the internal wall of the containment casing 9301 , which they are in contact with, up to the lower base 9312. In particular, said oblique walls 9307 extend with an inclination such as to allow the passage of precipitate through the outlet channel 9309.

In this way, the sample to be extracted can be concentrated in the central area of a lower portion of the test tube 93 and promote better agglomeration of the precipitate 9305 to be collected.

In some embodiments, said second cylindrical portion of the exit channel can include an access with a safety closure 934.

In some embodiments, said output channel can be configured to avoid contamination from the external environment. In particular, the safety lock 934 can guarantee isolation from external agents.

In some embodiments, the test tube 93 may include a valve 9308, which allows said sample to be taken using an external sampling instrument, or through the insertion of the vacuum sampling instrument.

The use of the valve 9308 in combination with a vacuum sampling instrument can guarantee a sample collection that is not contaminated by external agents, such as other bacteria, fungi, or viruses.

Referring to figure 6, valve 9308 may be in contact with outlet channel 9309.

In some embodiments, the valve 9308 can be self-occluding so that, at the end of the sampling, using the external instrument, the self-occluding valve 9308 can automatically close, preventing accidental leakage of the sample present in the test tube 93.

This use is of particular relevance when it is necessary to obtain an aseptic analysis, for example, for samples of blood or other notoriously sterile biological fluids (cerebrospinal fluid, synovial fluid).

Referring again to figure 6, the test tube 93 can include a separation means 9306, for separating the precipitate deposited on the walls of the test tube 93 and then extracting said sample through the outlet channel 9309.

Furthermore, the separation means 9306 can have a spherical, parallelepiped, square, conical, or other shape, to detach the precipitate adhered to the walls of the test tube 93.

In some embodiments, the separation means 9306 may comprise a glass material. The separation means 6 may comprise other materials.

In some embodiments, the separation means 9306 is able to float on the liquid contained in the test tube 93 and, when the test tube 93 is mechanically shaken, capable of touching the internal walls of the same, in such a way as to facilitate the detachment of the particles of sample that adhere to (are deposited on) said internal walls.

Furthermore, referring to figure 7, the test tube 93 can include a drawing and filling tube 9321 to withdraw and/or infuse, from the upper base 9311 , the solution to be analyzed and/or the waste parts, or the parts of the sample in suspension (supernatant).

In some embodiments, as can be seen from figure 8, the drawing and filling tube 9321 can be in contact with the upper base 9311 , at one of its proximal ends 93211 , and have a distal end 93212 arranged inside the containment casing 9301 .

Said drawing and filling tube 9321 can have a length shorter than the length of the test tube 93, for example, between approximately 25% and 80% of the length of the test tube 93.

Consequently, the distal end 93212 of the drawing and filling tube 9321 can be immersed, at least partially, in said sample in solution, close to the particles of the sample in suspension.

In some embodiments, the containment casing 9301 can include a narrowing of the lateral surface near the lower base 9312, so as to form a portion of the tube 93 with a conical section.

This configuration is particularly advantageous for processing the solution inside the test tube itself, for example by inserting the test tube into a centrifuge or autoclave.

Referring to figures 6 and 7, the test tube 93 can include a sampling and filling port 932 to insert the sample to be analyzed and/or, in a second step, withdraw a portion of the sample in suspension (supernatant).

The sampling and filling port 932 can be coupled to the drawing and filling tube 9321 , and be in contact with the upper base 9311 .

In some embodiments, the sampling and filling port 932 may be partially integrated into the upper base 9311 , with a portion of the port protruding from the upper base 9311 , and which may connect via a luer-lock system or other connection system to a tube or to a filling or sampling tool.

In particular, said sampling and filling port 932 can be configured to insert the sample to be analyzed into said test tube 93 and/or to extract the supernatant 9302, for example, via a self-occluding valve, and to connect with syringes and/or luer- lock systems without using additional needles.

In some embodiments, the test tube 93 may further comprise a duct 931 having an air filter membrane used to avoid external contamination of the sample to be analyzed, and for the extraction of excess air in the test tube 93.

Referring again to figure 6, the duct 931 may comprise a tubular shape arranged to extend substantially perpendicular to said upper base 9311 . The presence of this duct 931 for the air extraction facilitates the insertion and the withdrawal of the sample to be analyzed from the test tube 93 and avoids contamination of the sample by external agents thanks to the filter membrane, which can include a preferably antimicrobial filter.

The combination of the air extraction duct 931 with the outlet channel 9309 and the sampling and filling port 932 facilitates the filling and the extraction of a plurality of components of the sample to be analyzed while maintaining the solution in a non-contaminated environment to preserve the integrity of the sample.

As can be seen from figure 8, a portion of a duct 93T for extracting excess air can be arranged inside the casing 9301.

The device 1 cooperates with the test tube 93 forming a kit for the collection, transport and processing of biological samples, as the liquid extracted from the bag 1 is transferred to the test tube 93, in which it is processed.

When the sample to be analyzed is collected, it can be placed in a solution contained inside the test tube 93 via the port 932.

The solution that has been collected inside test tube 93 is processed.

The way of processing the solution containing the sample can vary depending on the type of sample and the type of analysis to be conducted on the sample itself.

When processing the solution involves separating the sample into a plurality of phases, for example, creating a multiphase system, in which at least one supernatant 9302 is suspended in said solution and a precipitate 9305 settles at the bottom of the test tube 93, it is possible to stir the solution mechanically. A bi-phasic system is a non-limiting example of a multi-phasic system.

In some embodiments, said mechanical agitation may involve centrifugating the solution.

The operation of the test tube 93 also includes extracting, from said test tube, the sample contained in said solution after the latter has been processed.

This extraction can be selective, so as to extract exclusively the precipitate 9305 through the outlet channel 9309.

Selective extraction of the 9305 precipitate can be ensured by activating the separation means 9306 to separate the sample from the walls of the tube 93 by shaking the tube 93.

The separation means 9306, in fact, can be activated by shaking the test tube 93 and, by touching the walls of the test tube 93, push away the precipitate particles deposited on the walls, thus increasing the sample extraction capacity.

In some embodiments, extracting the sample may include taking the supernatant 9302, for example, from above, via the drawing and filling tube 9321 connected to the drawing and filling port 932. This allows the amount of material to be reduced in unwanted suspension inside the test tube, or to analyze a plurality of components (or phases) of the solution.

Advantages

The use of dithiothreitol (DTT) and/or N-acetyl-cysteine and/or glutathione, and/or Mesna or others facilitates the breakdown of the biofilm and the preservation of biological samples and the like from external contaminating agents.

The present invention allows the collection, conservation, and processing of the biological material to be analyzed through a closed circuit starting from the surgical/outpatient environment up to an analysis center, therefore increasing the sensitivity and above all the specificity of the analysis.

The preparation of the freeze-dried product prevents the risk of oxidation for the anti-contaminant agent, for example, DTT, so the freeze-dried product has a greater durability than the anti-contaminant agent in the liquid state.

Therefore, the freeze-dried and/or liquid product can be stored for longer, as said product being stored in the polypropylene container 4 does not allow air or liquid to migrate through the walls.

The need for highly qualified personnel and specific machinery is reduced.

This device allows processing types of samples that are excluded from processing by sonication.

The single doses present in container 4 act as a separation barrier from air and water, preventing the degradation of the freeze-dried product molecule, which can be sensitive to both air and water.

The device reduces external contamination, as it is not conditioned by further manipulations or by manual sampling, and/or passages or with a syringe or the like.

The device allows flexibility for sample processing. In fact, if it is necessary to process the samples on the same day as the collection, the solution can be prepared starting from the freeze-dried product in the laboratory (and open the valve to wet the samples). If the samples are processed within 48 hours after collection, it is possible to prepare this solution and store the device in the fridge at a temperature of, for example, 4°C. However, when the samples need to be processed between 48 and 72 hours after collection, it is possible to store the device in the freezer, between -40°C and 0°C, for example, -20°C while maintaining the solution separated from the freeze-dried product. At the time of processing, the device can be thawed and the solution can be prepared starting from the freeze-dried product and, if necessary, the valve can be opened to proceed with the analysis.

The present invention allows the samples to be analyzed, to be processed, increasing the efficiency of sample collection.

The test tube allows the extraction of the precipitate downstream of the test tube, reducing the complexity of collecting said precipitate from above and increasing the sampling speed.

The tube reduces external contamination, as it does not require opening the device to extract the sample or part of it.

A further advantage consists in favoring the selective release of the sample to be extracted, for example, based on the specific weight of the component to be analyzed.

The test tube also allows the sample to be extracted in a controlled manner. Therefore, the quantity necessary for the analysis can be extracted, avoiding sample losses or the risk of contamination due to the external environment.

Furthermore, the test tube allows the simultaneous collection of two components of the sample. This aspect is particularly advantageous when it is necessary to differentiate and analyze said two components.

The present invention has been described for illustrative but not limitative purposes, according to its preferred embodiments, but it is to be understood that modifications and/or changes can be introduced by those skilled in the art without departing from the relevant scope as defined in the enclosed claims.

Claims

1 . Device (1 ) for medical-surgical use for the collection of biological samples or the like to be analyzed, having: at least one collection compartment (2) provided with a hermetically closable opening, intended to contain said biological samples or the like to be analyzed; at least one containment chamber (3) comprising a solvent of said lyophilized and/or liquid product, and at least one container (4), in turn containing a lyophilized and/or liquid product for the chemical detachment of bacteria and/or the desegregation of microbial biofilm from said biological samples or the like to be analyzed, and wherein said containment chamber (3) is selectively communicating with said collection compartment (2); and wherein said at least one container (4) is configured to selectively open and dissolve said lyophilized and/or liquid product in said solvent.

2. Device (1 ) according to the preceding claim, wherein said containment chamber (3) is compressible in such a way that, when said containment chamber is compressed, said at least one container (4) opens to dissolve said lyophilized and/or liquid product in said solvent.

3. Device (1 ) according to any one of the preceding claims, wherein said lyophilized and/or liquid product comprises lyophilized dithiothreitol (DTT), N- acetylcysteine, glutathione, and/or MESNA, or other solution for the desegregation of microbial biofilm.

4. Device (1 ) according to any one of the preceding claims, wherein said containment chamber (3) comprises a reagent capable of combining with said lyophilized and/or liquid product to produce a liquid that can be used for the chemical detachment of bacteria and/or or disruption of microbial biofilm from said biological samples and the like to be analyzed.

5. Device (1 ) according to any one of the preceding claims, wherein said collection compartment (2) is made of soft and/or compressible material.

6. Device (1 ) according to any one of the preceding claims, wherein said containment chamber (3) communicates with said collection compartment (2) so that said lyophilized and/or liquid product, when in solution, can be transported by said containment chamber (3) to said collection compartment (2) for the chemical detachment of bacteria from said biological samples and the like to be analyzed.

7. Device (1 ) according to any one of the preceding claims, wherein said at least one container (4) is a vial configured to be opened by breaking the same.

8. Device (1 ) according to any one of the preceding claims, wherein said containment chamber (3) comprises a valve for selectively communicating with said collection compartment (2).

9. Device (1 ) according to any one of the preceding claims, comprising extraction means (6), wherein said collection compartment (2) comprises a valve for selectively communicating with said extraction means (6).

10. Method of collection, transport, and processing of biological samples or the like by means of a device (1 ) according to any one of the preceding claims, which comprises the following steps: opening said device (1 ) and positioning, within said collection compartment (2), the samples to be stored, transported and/or analyzed; hermetically closing said device (1 ); compressing a portion of said containment chamber (3) to open said at least one container (4); dissolving a lyophilized and/or liquid product contained in said at least one container (4) in a solvent contained in said containment chamber (3); and connecting the containment chamber (3) with the collection compartment (2).

11 . Method according to the preceding claim comprising the following steps: opening a valve to connect said collection compartment (2) with said extraction means (6); and withdrawing a fraction of said samples or the like from the collection compartment (2).

12. Method according to claim 10 or 11 , wherein the step of hermetically closing said device (1 ) comprises removing the air from said collection compartment (2).

13. Method according to claim 11 or 12, comprising the step of withdrawing a fraction of a solution containing said samples or the like from the collection compartment (2), wherein said step of withdrawing a fraction of a solution comprises the sub-step of releasing in an aseptic way said solution containing samples or the like, taken from the collection compartment (2), in a test tube (93) for the analysis of biological samples or the like.

14. Method according to the preceding claim comprising the steps of processing said solution released in said test tube (93) by activating a separation means (9306) comprised in said test tube (93) to separate the sample deposited on the internal walls of the test tube (93), and extracting, from said test tube (93), the sample contained in said processed solution, avoiding contamination from the external environment.

15. Kit for medical-surgical use for the collection, transport and processing of biological or similar samples to be analyzed, which includes a device (1 ) for the collection and transport of biological or similar samples to be analyzed according to any of the claims 1 -9, said device being equipped with extraction means (6) capable of withdrawing a fraction of a solution containing samples or similar from said collection compartment (2), and a test tube (93) connectable to said extraction means (6), said test tube (93) being suitable for collecting and processing said solution taken, and for extracting samples contained in said processed solution.