Collection device and method for transporting and processing biological samples in fully sterile supply chain

Abstract

Medical-surgical device (1) for collecting a biological sample or the like to be analyzed, having at least one collection compartment (2) provided with a sealingly closable opening intended to receive the biological sample or the like to be analyzed; at least one accommodation chamber (3) comprising at least one container (4) which in turn accommodates a lyophilized product and / or a liquid product for the chemical isolation of bacterial and / or microbial biofilms from said biological sample or analogue to be analyzed, and a solvent for said lyophilized product and / or liquid product, wherein the accommodating chamber (3) is selectively communicated with the collecting compartment (2); and wherein the at least one container (4) is configured to selectively open and dissolve the lyophilized product and / or liquid product in the solvent. The invention also relates to methods and kits for collecting, transporting and processing biological samples or the like using said device (1).

Description

[0001] The present invention relates to a collection device and method for transporting and processing biological samples in a sterile supply chain, in particular a bag and a carrier system for biological materials to be processed, which are hermetically closed and free from external contamination, for collecting and transporting transplant samples and biological and non-biological materials for chemical-clinical and microbiological analysis.

[0002] Also disclosed are apparatus and methods for handling in a sterile supply chain, in particular test tubes for laboratory applications in clinical and biological fields, and methods for handling the same. Technical Field

[0003] More specifically, the present invention relates to a sterile device for medical-surgical use, which is suitable for collecting and transporting biological samples (biological fluids, tissues, organs and parts thereof) and / or implantable or prosthetic materials (such as but not limited to joint prostheses or parts or components thereof, metal plates, metal wires, rings, screws, nails, bone cement, bone substitutes, cannulas, heart valves, breast prostheses, urological prostheses, neurosurgical prostheses and osteosuture materials, dental or maxillofacial prostheses, etc.) transplanted during surgical operations from surgical / ambulatory departments to clinical and microbiological analysis laboratories, in this way completely protecting them from bacterial contamination.

[0004] In addition to those mentioned, the present invention may have various applications in the laboratory and clinical fields, including the preparation of PRP (platelet rich plasma) in the human and veterinary fields, the collection of particles, supernatants and intermediates in various forms in fields ranging from microbiology to biochemistry to hematology; biopsies in microbiology and oncology and in all branches of medicine where biological and non-biological solutions are used, for use in medical devices or liquid dispensers, or collection systems requiring centrifugation, including urine, respiratory material, blood, synovial fluid, exudates and pus, or liquid or semi-liquid biological materials, etc., which require a closed system for transport and processing.

[0005] In the following, the description will be directed to the collection and transport of transplant biospecimens for clinical and microbiological analysis, but it should obviously not be considered limited to this specific use.

[0006] According to another aspect, a test tube is provided, which is designed and manufactured to be particularly suitable for general medical-surgical and laboratory purposes, suitable for protecting and analyzing fluids, homogenized tissues, cellular components, etc., obtained from collected samples, and sent to chemical-clinical and / or microbiological analysis laboratories. The sample collected can be a biological sample, such as a biological fluid, tissue, cell extract and their parts, organs and their parts, or a liquid extracted from a solution containing implantable or transplantable prosthetic materials, synthetic media, cements, amalgams, Moser (morcels), sutures during an operation to protect them from bacterial contamination. The device of the type mentioned can be used to process samples in solutions or suspensions, regardless of the collection method and the need for chemical, clinical and microbiological analysis thereof. Hereinafter, the description will focus on the test tube for processing biological samples, but it is obvious that it should not be considered to be limited to this specific use. Background Art

[0007] It is well known that prosthetic components, biological specimens and / or the like collected for analysis in the operating room can become contaminated with bacterial agents.

[0008] Furthermore, it is well known that even the transport and handling of such organisms and / or similar samples before analysis can lead to contamination, which can interfere with the analysis of the samples themselves, limiting their sensitivity and specificity.

[0009] Currently, the sensitivity and reproducibility of in vitro assays starting from biopsy material can be significantly reduced by the presence of contaminating agents, including but not limited to biofilms, microorganisms, and bacteria. In addition, previous antibiotic treatment, for example, on the subjects from whom these samples were collected, is a source of error for the assays.

[0010] Although these factors cannot be excluded from the analysis, in order to avoid erroneous diagnoses, inappropriate definition of treatment and the resulting undesirable side effects, it is necessary to eliminate or at least reduce errors caused during sampling, or collection, transportation and handling of the sample to be analyzed and / or similar samples.

[0011] Clearly, an incorrect diagnosis of an implant-related infection, or a diagnosis obtained over an extended period of time, carries unsustainable social and economic impacts, as well as excessive medico-legal risks and costs.

[0012] As is known, various methods are known to extract bacteria from prostheses, mainly through physical or chemical action.

[0013] The first physical process, called sonication, uses a mechanical instrument to remove bacteria from implants or prostheses. This system has been shown to effectively increase the percentage of microorganisms isolated when the microorganisms are immersed and surrounded by a biofilm and firmly attached to the prosthetic material.

[0014] However, this technique has no application with biopsy materials, liquids, or prosthetic materials containing polymethylmethacrylate or cement, especially when impregnated with antibiotics.

[0015] Furthermore, sonication requires long application times and high costs, as well as specially trained and dedicated personnel (manpower costs). These limitations mean that it can only be used in a few hospital centers.

[0016] Chemical separation systems based on bacterial thiols, such as dithiothreitol, are known to exist in prosthetic implants and in biological samples obtained from biopsies by in vitro culture. This technology is low-cost and simple to use.

[0017] Related prior art also includes patent applications WO 96 / 14570A1 and US2017 / 136454A1.

[0018] However, storage of chemical formulations prior to use is limited due to potential oxidation.

[0019] Therefore, there is a clear need for a system and / or method to improve the durability of chemical formulations prior to use.

[0020] Test tubes are also known as purely tubular devices for containing various samples, such as blood, urine, sputum and solutions containing other samples to be analyzed in analytical and microbiological laboratories.

[0021] As is known, test tubes currently on the market have two inner draw tubes of different lengths.

[0022] Typically, the tubes are made of a material that allows the sample to be processed inside the tube. Common materials include borosilicate glass (pyrex) or plastic materials such as PET. These materials allow the tubes to be inserted directly into a centrifuge to facilitate separation of sample components, particularly the supernatant and the sediment.

[0023] The shorter length of the dip tube is used to draw or collect the supernatant of the sample, while the longer length of the dip tube is used to recover the sample to be analyzed that has settled in the lower portion of the tube or pellet.

[0024] Thus, it is known that after a centrifuge, the shorter drain tube is used to eliminate the suspended fraction, which is usually not used for analysis, while the longer drain tube is used to recover the precipitate.

[0025] As is well known, the ability to remove the sediment from the bottom of the test tube is limited due to its typically high density.

[0026] Furthermore, the precipitate is often very viscous or agglomerated, especially when subjected to centrifugal forces, making recovery of the precipitate itself more difficult.

[0027] It is estimated that approximately 30% of the sediment remains trapped in the aspiration tubing or inside the test tube due to clogging of the test tube itself.

[0028] It is therefore apparent that there is a need to provide a device which facilitates the recovery of sediment and reduces the amount of sediment which remains in the suction tubing used to recover the sediment.

[0029] Scope of the Invention

[0030] Therefore, in light of the above, the scope of the present invention is to reduce exogenous and endogenous contamination of biological and / or similar samples to be analyzed during their collection.

[0031] Another scope of the present invention is to reduce the contamination of biological and / or similar samples to be analyzed during their transport from the operating room to the analysis center and during their processing.

[0032] Another scope of the invention is to ensure the isolation of pathogenic microorganisms, dissolve and eliminate biofilms, facilitate their separation or decomposition from biological materials, to facilitate their detection and subsequent identification, and to faithfully reproduce the actual microbial ecosystem causing the infection in the sample collected.

[0033] Another object of the present invention is to provide tools and equipment for implementing the method.

[0034] According to another aspect, a test tube is provided that enables the extraction of a precipitate to be analyzed, preventing the risk of contaminating the sample and providing a low-cost and easy-to-use solution.

[0035] Also provided is a method for operating the tube for collecting samples and extracting precipitates and / or collecting supernatant to be analyzed.

[0036] Also provided are tools and equipment required to implement the method. Summary of the Invention

[0037] These and other results are obtained according to the invention by a device which can be sterilely and hermetically closed for medical-surgical use in collecting, transporting and processing biological or analogous samples to be analyzed.

[0038] A particular object of the present invention is therefore a medical-surgical device for collecting biological or similar samples for analysis.

[0039] The device comprises at least one collecting compartment and at least one holding chamber.

[0040] The collecting compartment is provided with a hermetically closable opening and is intended for receiving said biological sample or the like to be analyzed.

[0041] The holding chamber comprises at least one container which in turn holds a freeze-dried and / or liquid product for chemically separating bacteria and / or microbial biofilms from the biological or similar sample to be analyzed.

[0042] The holding chamber also includes a solvent for dissolving the freeze-dried and / or liquid product.

[0043] Furthermore, the holding chamber is selectively in communication with the collection compartment, and the at least one container is configured to selectively open and dissolve the lyophilized and / or liquid product in the solvent.

[0044] Furthermore, according to the present invention, the device may comprise a compressible receiving chamber, such that when said receiving chamber is compressed, said at least one container opens to dissolve said freeze-dried product in said solvent.

[0045] Preferably, according to the present invention, the freeze-dried product may include freeze-dried dithiothreitol (DTT) and / or N-acetylcysteine ​​and / or glutathione, mercaptoethanesulfonate (MESNA) or other solutions capable of dissolving biofilms and microbial aggregates.

[0046] Furthermore, according to the present invention, the holding chamber may include a reagent capable of combining with the freeze-dried product to produce a liquid that can be used to chemically separate bacteria and / or microbial biofilms from the biological sample or the like to be analyzed.

[0047] Still according to the invention, the collecting compartment may be made of a soft and / or compressible material.

[0048] Again according to the invention, the holding chamber can be in communication with the collecting compartment so that the lyophilized product, when in solution, can be transferred from the holding chamber to the collecting compartment for chemical separation of bacteria from the biological sample or the like to be analyzed.

[0049] Preferably, according to the present invention, the at least one container may be a bottle configured to be opened by breaking.

[0050] Still according to the invention, the receiving chamber may comprise a valve to selectively communicate with the collecting compartment.

[0051] Furthermore, the apparatus may comprise an extraction device, wherein the collection compartment comprises a valve for selective communication with the extraction device.

[0052] In addition, a specific object of the present invention is a method for collecting, transporting and processing biological samples or the like by means of a device for collecting, transporting and processing biological samples or the like, the method comprising the following steps: opening the device and positioning the sample to be stored, transported and / or analyzed in the collecting compartment; sealingly closing the device; compressing a portion of the receiving chamber to open the at least one container; dissolving the freeze-dried product contained in the at least one container in a solvent contained in the receiving chamber; and connecting the receiving chamber and the collecting compartment.

[0053] Preferably, according to the present invention, the method may further comprise the steps of: opening a valve to connect the collection compartment and the extraction device; and withdrawing a portion of the solution containing the sample-containing liquid or the like from the collection compartment.

[0054] Furthermore, the step of closing the device may comprise removing air from the collection compartment when the sample has been collected.

[0055] A particular object of the invention is therefore the device defined in claim 1 .

[0056] Preferred embodiments are defined in the dependent claims.

[0057] According to another aspect, a device, in particular a test tube, is provided for medical-surgical use for the analysis of biological samples or the like. The device comprises a housing for containing the sample to be analyzed in solution or suspension, the housing extending primarily along the lower base for extracting the sample from the housing.

[0058] Preferably, the tube can allow extraction while avoiding contamination of the formulation from outside the device itself.

[0059] The test tube may comprise separation means for selectively separating the sample from the inner wall of the housing and for extracting the sample through the outlet channel.

[0060] The cuvette may include a valve configured to prevent accidental leakage of the sample through the channel.

[0061] The valve may be placed in contact with the outlet channel and be self-closing, thereby allowing the sample to flow out in a controlled manner and avoiding accidental leakage of the sample.

[0062] Preferably, the separation means comprises glass balls.

[0063] The test tube may include an aspiration and filling tube configured to aspirate and / or insert the sample into a solution or suspension, having a proximal end and a distal end, wherein the proximal end is in contact with the upper base of the containment shell and the distal end is arranged inside the containment envelope and configured to be immersed in the sample in suspension or solution, and a sampling and filling port connected to the proximal end of the drainage tube.

[0064] Advantageously, the test tube is suitable for analyzing a biological sample or the like in a solution having a supernatant portion and a sediment portion, wherein the drainage tube allows the withdrawal of the supernatant portion and the outlet channel allows the extraction of the sediment portion.

[0065] The tube may include a conduit disposed in contact with the upper base and configured for air extraction.

[0066] The output channel may be configured to couple to a syringe or holder to acquire a sample.

[0067] The outlet passage may comprise a narrowed portion of an interior wall.

[0068] The withdrawal and fill port may be configured to connect to a syringe and / or a Luer lock system.

[0069] According to another aspect, a method for operating a device, in particular a test tube, for medical-surgical analysis of biological or similar samples to be analyzed comprises the following steps: collecting a solution containing the sample to be analyzed in a test tube as described above, treating the solution containing the aseptically collected sample, and extracting the sample contained in the treated solution from the test tube. This method avoids contamination from the external environment because the test tube separates the solution or suspension containing the sample from the external environment.

[0070] Advantageously, the step of treating the solution may comprise treating the solution to produce a multiphase system comprising a supernatant portion and a precipitate portion; and the step of extracting a sample may comprise the step of selectively extracting the precipitate portion and / or obtaining the supernatant portion.

[0071] The method may include operating a partitioning device to partition and selectively extract the sample to be analyzed deposited on the wall of the housing from the wall.

[0072] The method may include extracting air from the tube via a conduit and / or withdrawing the supernatant portion via a withdrawal and fill port for the supernatant portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] The present invention will now be described, for illustrative and not limiting purposes, in accordance with preferred embodiments of the invention, with particular reference to the accompanying drawings, in which:

[0074] Figure 1 A closed collection device for transport and handling in a sterile supply chain is shown;

[0075] Figure 2 A biological specimen collection compartment is shown;

[0076] Figure 3 Shown include Figure 1 The system of the device shown and the container connected thereto;

[0077] Figure 4 Shown Figure 1 A device comprising a collecting compartment and a receiving chamber in communication;

[0078] Figure 5 A closed loop sampling system is shown which may be connected to the collection compartment for extracting the liquid present therein;

[0079] Figure 6 An embodiment of a test tube is shown in sections and assembled, which can be connected to a collecting device, the object of the present invention;

[0080] Figure 7 An embodiment of a test tube is shown in sections and exploded views, which can be connected to a collecting device, the object of the present invention; and

[0081] Figure 8 Shown in sections Figure 6 Example of a test tube. DETAILED DESCRIPTION

[0082] In different drawings, similar parts will be denoted by the same reference numerals.

[0083] Reference Figure 1 The device 1 mainly includes a collecting compartment 2 and a containing chamber 3.

[0084] Said containment chamber 3 contains inside it a solvent and a container 4 intended to contain in turn the freeze-dried product to be selectively combined with said solvent.

[0085] The device is preferably a sterile, hermetically resealable bag for medical-surgical use, suitable for collecting biological specimens from operating rooms and transporting them to clinical and microbiological analysis laboratories.

[0086] In some embodiments, the device 1 preferably has a construction made of polyvinyl chloride (PVC), which is a durable, non-puncturable, and heat-sealable material.

[0087] In some embodiments, the device 1 is essentially a preferably transparent bag made of polyethylene or polypropylene.

[0088] The collecting compartment 2 has a sealingly closable opening 21 and is intended for receiving a biological or similar sample to be analyzed.

[0089] The closable opening 21 may comprise a pressure-closable zipper, for example, by applying a vacuum. Zippers, safety closures or closures.

[0090] Reference again Figure 1 , the collection compartment 2 may include a solution extraction system for collecting the sample to be analyzed.

[0091] In particular, the extraction system may include a filter 24 to facilitate extraction of liquid from the collection compartment 2 , for example for transfer to a tube, for example tube 93 , as described below, an extraction device 6 and a valve to connect the extraction device and the collection compartment 2 .

[0092] In some embodiments, the collecting compartment 2 may comprise a one-way filter 24 to facilitate the passage of material from the collecting compartment 2 to the extraction device 6 while avoiding contamination from the extraction device to the collecting compartment 2 .

[0093] In some embodiments, the apparatus 1 may comprise said extraction means 6 to extract liquid from the collection compartment and transport it to, for example, one or more dedicated test tubes for collection and analysis, which may allow the collection of the supernatant and particles deposited at the bottom of said one or more test tubes after centrifugation.

[0094] In some embodiments, said extraction means 6 may be included in said apparatus 1 in order to obtain a closed circuit and avoid contamination.

[0095] In some embodiments, collection of supernatant and particles can be performed via at least one specific connection present on one or more tubings.

[0096] Always refer to Figure 1 , the receiving chamber 3 is part of the collecting compartment 2 .

[0097] In some embodiments, the receiving chamber 3 and the collecting compartment 2 are electrically welded together.

[0098] In addition, if Figure 1 、 Figure 3 and Figure 4 As shown, the receiving chamber 3 may include a valve 5 to selectively connect the receiving chamber 3 and the collecting compartment 2 .

[0099] The valve 5 may comprise a stem 51 configured to rupture, preferably due to compression of the containment chamber 3 .

[0100] Thus, rupturing the rod 51 makes it possible to put the containment chamber 3 in communication with the collecting compartment 2 , so that the sample collected in the device 1 is moistened with the solution in which the freeze-dried product has been previously dissolved.

[0101] In some embodiments, the valve 5 may comprise a cap, which may be coupled to a thread, for example, which allows the valve to be selectively opened also from outside the containing chamber 3 .

[0102] In this way, manipulation of the solvent and / or solute (lyophilized product) is avoided.

[0103] The receiving chamber 3 is configured to receive the freeze-dried product and a solvent to make the freeze-dried product liquid when necessary, ie, when it is necessary to preserve the biological sample to be collected, transported, and analyzed.

[0104] In particular, to prevent the freeze-dried product from coming into contact with solvents until necessary, the freeze-dried product is contained in a container, such as a bottle, vial, or the like, which separates the freeze-dried product from its surroundings.

[0105] Reference numeral 4 denotes the container containing the freeze-dried product.

[0106] refer to Figure 1 , container 4 is a polypropylene bottle.

[0107] The polypropylene bottles are preferably rigid bottles that can hold varying amounts, for example, 50, 100 or 150 micrograms (μg) of the lyophilized product and are opened by twisting at the rupture point.

[0108] The amount of lyophilized product in the container 4 can vary depending on the solution to be prepared, based on the size of the collecting compartment 2. The 50 μg bottle can be rigid, with a twist-open system or a screw cap.

[0109] In fact, for a device with a containing chamber 3 with a volume of 50 ml, there may be 50 μg of freeze-dried product in the container 4, while for a containing chamber 3 with a volume of 100 ml, there will be, for example, 100 μg of freeze-dried product in the container 4, and 150 μg of freeze-dried product in a bag with a containing chamber 3 with a volume of 150 ml.

[0110] In some embodiments, the vial can hold an amount greater than 50 μg, for example, 75 μg, 100 μg, 200 μg, or 500 μg, for which closure can be secured by a rubber stopper and / or sealed with an outer tamper-evident screw cap.

[0111] In alternative embodiments, there may be one or more containers 4 , for example several propylene bottles, each containing an amount equal to 50 μg of freeze-dried product. In these embodiments, the number of containers 4 may vary depending on the volume of the containment chamber 3 .

[0112] Container 4 can contain a freeze-dried product in powder, solid or liquid form to be dissolved in a solvent and can include dithiothreitol (DTT), N-acetylcysteine, glutathione, mesna or any other solution capable of dissolving biofilms and / or facilitating separation and / or isolation of microorganisms in a truly reliable manner.

[0113] Other solutions capable of dissolving biofilms and / or promoting separation and / or isolation of microorganisms include organic and inorganic chemicals with reducing activity, microbial, bacterial or fungal extracts, and peptides with antibiofilm activity.

[0114] Other solutions capable of dissolving biofilms and / or promoting the separation and / or isolation of microorganisms include organic and inorganic chemicals with reducing activity, microbial, bacterial or fungal extracts, and peptides with antibiofilm activity.

[0115] In some embodiments, the containment chamber 3 may include a plurality of containers 4, each container containing a product capable of dissolving biofilm and / or facilitating separation and / or isolation of microorganisms.

[0116] The device 1 may further include an opening 22 to introduce a solvent into the inside of the receiving chamber 3 .

[0117] refer to Figure 3 The device 1 may further comprise an additional container 8 which may be welded, glued or coupled to the collecting compartment 2 and / or the receiving chamber 3 in a similar manner.

[0118] The additional container 8 may be used to indicate (for example, written using laser technology) instructions for the operation to be performed and / or the date of use of the device 1 or the freeze-dried product contained therein.

[0119] An additional container 8 may also be configured to accommodate means for extracting and collecting liquid to be analyzed (eluate) from the device 1 .

[0120] Reference again Figure 3 , said additional container 8 is connected to the collecting compartment 2 and / or the containing chamber 3 by means of a connection line 23 and a diamond seal, in order to connect the container to the device 1 in which it is included.

[0121] from Figure 3 As can be seen in FIG. 1 , the device 1 may comprise a fastening element 7 , such as a clamp, to sealingly close the collecting compartment 2 and reduce movement of the biological sample collected inside said compartment.

[0122] The fastening element 7 may comprise one or more hook teeth 71 for securing the fastening element 7 around the device.

[0123] refer to Figure 4 , showing Figure 1 devices, but in different stages of operation. Figure 1 As shown, the inner side of the receiving chamber 3 is isolated from the collecting compartment 2, and the inner side of the container 4 is also isolated from the receiving chamber 3. Figure 4 As can be seen in FIG, the container 4 is open, so that the freeze-dried product contained inside the container can come into contact with the solution present in the containing chamber 3.

[0124] In addition, from Figure 4 As can be seen in FIG, valve 5 is also open, so that the receiving chamber 3 is also in contact with the collecting compartment 2.

[0125] Furthermore, since the device 1 may be stored on a shelf or in a warehouse prior to use, a further closed protective bag may contain the device, protecting it from external contamination prior to use.

[0126] The operation of the above-described apparatus 1 is as follows.

[0127] When a biopsy, surgical harvest, removal of a limb or prosthesis is completed, it is necessary to preserve samples of these surgical procedures and collect the transplanted samples so that they can be transported to a laboratory for analysis using the hermetically closed and sterile device 1 .

[0128] Subsequently, the transplant sample (biological material and / or biopsy / biological sample) is inserted into the collecting compartment 2 , which must be hermetically closed.

[0129] In particular, the hinge 21 is opened, the sample is inserted therein, and the hinge can be closed again.

[0130] Closure can be ensured by hinges 21, clamps 7 or a combination of both.

[0131] In some examples, in order to open the hinge 21, it is necessary to grasp the two edges of the device 1, for example with both hands, and to perform a movement of the two edges in the direction of the closed axis, wherein the hinge 21 is extended by pushing one of the two flaps in one direction and the other flap in the opposite direction.

[0132] In some embodiments that include an external storage pouch, the storage pouch may be opened by the operator prior to opening hinge 21 .

[0133] The device 1 can be safely transported to the laboratory. In fact, the closed circuit of transport and processing of samples can minimize the risk of contamination of samples or operators.

[0134] In this connection, the receiving chamber 3 can be compressed from the outside, in this way opening the container 4 inside it and allowing the freeze-dried product contained therein to escape.

[0135] The opening of the container 4 may be caused by breakage, for example by twisting of one end of the container 4 .

[0136] Once the freeze-dried product contacts and dissolves in the solvent of the receiving chamber 3 , the receiving chamber 3 and / or the device 1 can be compressed or folded so as to allow communication between the receiving chamber 3 and the compartment collection 2 , for example by rupturing the valve 5 .

[0137] Furthermore, the receiving chamber 3 can be further pressed to allow the obtained solution, for example containing DTT, N-acetylcysteine ​​or glutathione (mesna), to be discharged towards the collecting compartment 2 .

[0138] Once the sample is collected, it is transported under sterile and safe conditions.

[0139] Reference Figure 1 and Figure 5 The liquid (eluate) present in the collecting compartment 2 can thus be transferred by drawing or extraction. In particular, the transfer is carried out by a closed circuit system comprising a connector 6 connected to a connector 91 which in turn is connected to a syringe 94 through which the liquid is extracted and further transferred to a tubing 93.

[0140] In some embodiments, there may be multiple tubes 93 depending on the size of the bag and the amount of eluate to be extracted.

[0141] In some embodiments where an extraction valve is provided, the extraction valve can be opened, eg frangible, to connect the collection compartment 2 with the extraction device 6 .

[0142] In addition, refer to Figure 5 Liquid or other material to be treated can be drawn off, for example, by means of a syringe 94 connected to the extraction device 6 by means of a connector 91 and / or a connecting tube 95 and transferred into one or more tubes 93 dedicated to treatment.

[0143] Transfer to the pipe 93 via the transfer conduit 96.

[0144] The transfer catheter 96 may include a transfer fixture 92 for selective switching from the syringe 94 to the tubing 93 .

[0145] When the sample is extracted from the device 1 and transferred to the test tube 93, the transfer clamp 92 can be opened.

[0146] Once the transfer has been completed, the transfer clamp 92 can be closed to allow the test tube 93 to be detached from the device 1 and thus processed, for example centrifuged.

[0147] In some embodiments, one or more test tubes 93 may include an inlet 932 , for example, arranged at an upper end of said test tube 93 , connectable to a syringe having a Luer lock system.

[0148] Thus, a syringe with a Luer lock system can be connected to the inlet 932 of the test tube 93, for example, to withdraw supernatant from said test tube.

[0149] from Figure 6 As can be seen in the figure, inside the test tube 93, there may be a glass ball 9306 placed near the lower base for removing by oscillation some of the particles that have gathered to the wall of the test tube 93 during the separation process.

[0150] In some embodiments, one or more tubes 93 may comprise an inlet 934 allowing connection without a needle due to an automatic or safety closure, for example, arranged at the lower end of said tube 93 and connectable to a syringe with a Luer lock system.

[0151] Thus, a syringe with a Luer lock system can be connected to the inlet 934 of the test tube 93, for example, to withdraw particles from said test tube 93, or alternatively connected to the test tube using the protective sleeve 99 to perform vacuum sampling.

[0152] Reference Figure 6 , shows a test tube 93 for medical-surgical use for analysis of biological samples or the like.

[0153] Tubing 93 is configured to collect a biological sample to be processed, for example, by treatment with a centrifuge, and facilitates collection of at least a portion of the sample.

[0154] In a preferred embodiment, test tube 93 is configured to collect and dispose of biological samples or the like. Nevertheless, the tube may be used for other types of samples, for example, to collect and dispose of samples extracted from corpses or for wastewater analysis.

[0155] The test tube 93 basically includes a receiving shell 9301 to receive the sample to be analyzed in a solution.

[0156] The accommodating shell 9301 includes a surface mainly extending along the X-axis, an upper base 9311 and a lower base 9312 .

[0157] In a preferred embodiment, the tube 93 may be substantially a tube in which the housing 9301 is cylindrical, and the side surface may be larger than the upper base surface 9311 and larger than the lower base surface 9312 .

[0158] In some embodiments, the side surfaces may be substantially larger than the base surface.

[0159] According to some embodiments, the lower base 9312 may include a portion removable from the test tube 93, substantially perpendicular to the X-axis, to serve as a support base for the test tube 93 on a flat surface, and which portion may be removed if necessary to facilitate operations such as extracting the precipitate from the test tube 93 itself.

[0160] The test tube 93 further includes an outlet channel 9309 in contact with the lower base 9312 for sample extraction.

[0161] The outlet channel 9309 mainly includes a sample outlet hole located at the bottom of the tube.

[0162] In particular, the outlet channel 9309 is configured to facilitate the discharge of sediment or precipitate formed after the sedimentation process, which results in the separation of solid particulate matter suspended therein (in the supernatant) from the liquid due to gravity or other forces, such as centrifugal force and / or electricity, resulting in the formation of sediment or sediment or particles.

[0163] Numeral reference 9302 indicates a liquid portion in which the supernatant is suspended.

[0164] Numeral reference 9305 indicates a portion of the precipitate.

[0165] The presence of the outlet channel 9309, unlike what happens in state of the art devices using a sediment aspiration system, where a dip tube of length equal to the length of the test tube is introduced from above, facilitates a more effective release of the sediment.

[0166] In fact, since the outlet channel 9309 is in contact with the lower base 9312, it allows the sediment to escape downstream of the tube, for example by gravity.

[0167] Additionally, in some embodiments, an outlet channel 9309 may extend through the lower base and facilitate connection of the tubing 93 to a collection instrument (eg, a syringe or holder 99).

[0168] In some embodiments, the outlet channel 9309 can have a first conical portion and a second cylindrical portion, wherein the angled wall 9307 can result in a defined narrowing of the surface of the outlet channel 9309 .

[0169] Reference Figure 6, the inclined walls 9307 extend from a portion of the inner wall of the accommodating housing 9301 with which they contact to the lower base 9312. In particular, the inclined walls 9307 extend obliquely, thereby allowing sediment to pass through the outlet channel 9309.

[0170] In this way, the sample to be extracted can be concentrated in the central area of ​​the lower part of the test tube 93, and promote better aggregation of the precipitate 9305 to be collected.

[0171] In some embodiments, the second cylindrical portion of the exhaust passage may include an inlet with a safety closure 934 .

[0172] In some embodiments, the output channel can be configured to avoid contamination from the external environment. In particular, a safety lock 934 can ensure isolation from external agents.

[0173] In some embodiments, the tube 93 may include a valve 9308 that allows the sample to be obtained using an external sampling instrument or by inserting a vacuum sampling instrument.

[0174] Using valve 9308 in conjunction with a vacuum sampling instrument ensures that the sample collection is not contaminated by external agents, such as other bacteria, fungi, or viruses.

[0175] refer to Figure 6 , valve 9308 can be in contact with outlet channel 9309.

[0176] In some embodiments, valve 9308 can be self-closing, such that at the end of sampling, using an external instrument, self-closing valve 9308 can automatically close, preventing accidental leakage of the sample present in test tube 93.

[0177] This use is particularly important when sterility analysis is required, for example, when performing sterility analysis on samples of blood or other well-known sterile biological fluids (cerebral spinal fluid, synovial fluid).

[0178] Reference again Figure 6 , the test tube 93 may include a separator 9306 for separating the precipitates deposited on the wall of the test tube 93 and then extracting the sample through the outlet channel 9309.

[0179] In addition, the partition device 9306 can have a spherical, parallelepiped, square, conical or other shape to separate the precipitates attached to the wall of the test tube 93.

[0180] In some embodiments, the spacer 9306 may comprise a glass material. The spacer 6 may comprise other materials.

[0181] In some embodiments, the separator 9306 is capable of floating on the liquid contained in the test tube 93 and, when the test tube 93 is mechanically shaken, of touching the inner wall of the test tube, thereby promoting the separation of particulate matter of the sample attached to (deposited on) the inner wall.

[0182] In addition, reference Figure 7 The test tube 93 may include a removal and filling tube 9321 to withdraw and / or inject the solution and / or waste portion to be analyzed, or a portion of the sample in suspension (supernatant) from the upper base 9311.

[0183] In some embodiments, Figure 8 It can be seen that the withdrawal and filling tube 9321 can be in contact with the upper base 9311 at one of its proximal ends 93211 and has a distal end 93212 arranged inside the containing shell 9301.

[0184] The removal and filling tube 9321 can have a length that is shorter than the length of the test tube 93 , for example, between approximately 25% and 80% of the length of the test tube 93 .

[0185] Thus, the distal end 93212 of the retrieval and fill tube 9321 can be at least partially immersed in the sample in the solution, close to the pellet of sample in suspension.

[0186] In some embodiments, the containment housing 9301 may include a narrowing of the lateral surface proximate the lower base 9312 to form a portion of the tube 93 having a tapered section.

[0187] This configuration is particularly advantageous for processing the solution inside the test tube itself, such as by inserting the test tube into a centrifuge or autoclave.

[0188] Reference Figure 6 and Figure 7 The test tube 93 may include a sampling and filling port 932 for inserting the sample to be analyzed and / or, in a second step, withdrawing a portion of the sample in the suspension (supernatant).

[0189] The sampling and filling port 932 can be connected to the withdrawal and filling tube 9321 and contact the upper base 9311.

[0190] In some embodiments, the sampling and filling port 932 can be partially integrated into the upper base 9311, with a portion of the port protruding from the upper base 9311 and can be connected to tubing or a filling or sampling tool via a Luer lock system or other connection system.

[0191] In particular, the sampling and filling port 932 can be configured to insert a sample to be analyzed into the test tube 93 and / or extract the supernatant 9302, for example, via a self-closing valve and connect with a syringe and / or Luer lock system without using an additional needle.

[0192] In some embodiments, the test tube 93 may further include a conduit 931 having an air filter membrane for preventing external contamination of the sample to be analyzed and for extracting excess air in the test tube 93 .

[0193] Reference again Figure 6 , the conduit 931 may include a tubular shape, which is arranged to extend substantially perpendicular to the upper base 9311.

[0194] The presence of this duct 931 for air extraction facilitates the insertion and 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 may comprise a preferably antibacterial filter.

[0195] The combination of the air extraction conduit 931 with the outlet channel 9309 and the sampling and filling port 932 facilitates the filling and extraction of the various components of the sample to be analyzed while maintaining the solution in a contaminant-free environment to preserve the integrity of the sample.

[0196] from Figure 8 As can be seen in FIG, a portion of the duct 931 ′ for extracting excess air can be arranged inside the housing 9301.

[0197] When the liquid extracted from the bag 1 is transferred to the test tube 93 and processed therein, the device 1 cooperates with the test tube 93 to form a kit for collecting, transporting and processing biological specimens.

[0198] When a sample to be analyzed is collected, it may be placed into the solution contained inside tube 93 via port 932 .

[0199] The solution that has collected inside the test tube 93 is processed.

[0200] The manner in which the solution containing the sample is processed may vary depending on the type of sample and the type of analysis being performed on the sample itself.

[0201] The solution can be mechanically agitated when processing the solution includes separating the sample into multiple phases, for example, creating a multiphase system in which at least one supernatant 9302 is suspended in the solution and a precipitate 9305 sinks to the bottom of the tube 93. A two-phase system is a non-limiting example of a multiphase system.

[0202] In some embodiments, the mechanical agitation may include centrifuging the solution.

[0203] The operation of the test tube 93 also includes extracting the sample contained in the solution from the test tube after the solution has been processed.

[0204] This extraction can be selective so that the precipitate 9305 is extracted specifically through the outlet channel 9309.

[0205] 9305 Selective extraction of the precipitate can be ensured by activating the separation device 9306 to separate the sample from the wall of the tube 93 by shaking the tube 93.

[0206] In fact, the separation device 9306 can be activated by shaking the test tube 93 and, by touching the wall of the test tube 93, pushes away the sediment particles deposited on the wall, thereby increasing the sample extraction capacity.

[0207] In some embodiments, extracting the sample can include obtaining the supernatant 9302 from above, for example, via a withdrawal and fill tube 9321 connected to a withdrawal and fill port 932. This allows for reducing the amount of unwanted material in suspension inside the tube, or analyzing multiple components (or phases) of the solution.

[0208] Advantages

[0209] The use of dithiothreitol (DTT) and / or N-acetyl-cysteine ​​and / or glutathione, and / or mesna or other substances helps to disrupt the biofilm and protect the biological sample or the like from external contaminating agents.

[0210] The present invention allows the collection, protection and processing of biological material to be analyzed through a closed circuit starting from the surgical / outpatient environment up to the analytical center, thus increasing the sensitivity and especially the specificity of the analysis.

[0211] The preparation of lyophilized products avoids the risk of oxidation of anti-contamination agents such as DTT, so lyophilized products have better durability than anti-contamination agents in liquid state.

[0212] Thus, the freeze-dried and / or liquid product can be stored for a longer period of time because the product stored in the polypropylene container 4 does not allow air or liquid to migrate through the walls.

[0213] The need for highly qualified personnel and specialized machinery is reduced.

[0214] This device allows for processing of types of samples that are excluded by sonication.

[0215] The single dose present in the container 4 acts as a separation barrier to air and water, preventing degradation of the molecules of the lyophilized product, which may be sensitive to both air and water.

[0216] The device reduces external contamination because it does not require further manipulation or manual sampling and / or access or adjustment with a syringe or the like.

[0217] The device allows flexibility in sample handling. In fact, if the sample needs to be processed on the day of collection, the solution can be prepared starting from the lyophilized product in the laboratory (and the valve opened to wet the sample). If the sample is processed within 48 hours after collection, the solution can be prepared and the device can be stored in a refrigerator at a temperature of, for example, 4°C. However, when the sample needs to be processed within 48 to 72 hours after collection, the device can be stored in a refrigerator at a temperature between -40°C and 0°C, for example -20°C, while keeping the solution separate from the lyophilized product. At the time of processing, the device can be thawed, and the solution can be prepared starting from the lyophilized product and, if necessary, the valve can be opened for analysis.

[0218] The present invention allows for analysis and processing of samples, thereby improving the efficiency of sample collection.

[0219] The test tube allows extraction of sediment downstream of the test tube, reducing the complexity of collecting said sediment from above and increasing the speed of sampling.

[0220] The tubing reduces external contamination because it does not require opening the device to extract the sample or a portion thereof.

[0221] Another advantage is that selective release of the sample to be extracted is facilitated, for example, based on the specific gravity of the components to be analyzed.

[0222] The tubes also allow for controlled sample extraction. Thus, only the amount required for analysis can be extracted, without the risk of sample loss or contamination due to the external environment.

[0223] Furthermore, the test tube allows for the simultaneous collection of two components of a sample, which is particularly advantageous when the two components need to be differentiated and analyzed.

[0224] The present invention has been described according to its preferred embodiments for illustrative and not restrictive purposes, but it should be appreciated that modifications and / or variations may be introduced by those skilled in the art without departing from the scope of the invention as defined in the appended claims.

Claims

1. A medical-surgical device (1) for collecting a biological sample or the like to be analyzed, comprising: at least one collecting compartment (2) provided with a hermetically closable opening, intended to receive the biological sample or the like to be analyzed; At least one accommodating chamber (3), the accommodating chamber comprising a solvent for the freeze-dried product and / or liquid product, and at least one container (4) which in turn contains a freeze-dried product and / or a liquid product for chemically separating bacteria and / or decomposing microbial biofilms from said biological sample or the like to be analyzed, and wherein, The receiving chamber (3) is selectively in communication with the collecting compartment (2); and Wherein, the at least one container (4) is configured to selectively open and dissolve the freeze-dried product and / or liquid product in the solvent.

2. Device (1) according to the preceding claim, wherein The receiving chamber (3) is compressible, so that when the receiving chamber is compressed, the at least one container (4) opens to dissolve the freeze-dried product and / or liquid product in the solvent.

3. The device (1) according to any one of the preceding claims, wherein The freeze-dried product and / or liquid product includes freeze-dried dithiothreitol (DTT), N-acetylcysteine, glutathione and / or mesna, or other solutions for decomposing microbial biofilms.

4. The device (1) according to any one of the preceding claims, wherein The containing chamber (3) comprises a reagent capable of combining with the freeze-dried product and / or liquid product to produce a liquid, which can be used to chemically separate bacteria and / or disrupt microbial biofilms from the biological sample or the like to be analyzed.

5. The device (1) according to any one of the preceding claims, wherein The collecting compartment (2) is made of a soft and / or compressible material.

6. The device (1) according to any one of the preceding claims, wherein The receiving chamber (3) is in communication with the collecting compartment (2), so that the freeze-dried product and / or liquid product can be transported from the receiving chamber (3) to the collecting compartment (2) when in solution for chemically separating bacteria from the biological sample or the like to be analyzed.

7. The device (1) according to any one of the preceding claims, wherein The at least one container (4) is a medicine bottle, and the medicine bottle is configured to be opened by rupturing the medicine bottle.

8. The device (1) according to any one of the preceding claims, wherein The receiving chamber (3) comprises a valve for selectively communicating with the collecting compartment (2).

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

10. A method for collecting, transporting and processing biological samples or the like by means of a device (1) according to any one of the preceding claims, said method comprising the steps of: opening the device (1) and positioning a sample to be stored, transported and / or analyzed within the collection compartment (2); sealing the device (1); compressing a portion of the receiving chamber (3) to open the at least one container (4); dissolving the freeze-dried product and / or liquid product contained in the at least one container (4) in the solvent contained in the containing chamber (3); as well as The receiving chamber (3) is connected to the collecting compartment (2).

11. The method according to the preceding claim, comprising the steps of: opening a valve to connect the collection compartment (2) and the extraction device (6); and A portion of the sample or the like is withdrawn from the collection compartment (2).

12. The method according to claim 10 or 11, wherein: The step of hermetically closing the device (1) comprises removing air from the collecting compartment (2).

13. The method according to claim 11 or 12, comprising the step of withdrawing a portion of the solution containing the sample or the like from the collecting compartment (2), wherein The step of extracting a portion of the solution includes a sub-step of releasing the solution containing the sample or the like taken from the collection compartment (2) into a test tube (93) in a sterile manner for analysis of the biological sample or the like.

14. The method according to the preceding claim, comprising the following steps processing the solution released in the test tube (93) by activating a separation device (9306) contained in the test tube (93) to separate the sample deposited on the inner wall of the test tube (93), and The sample contained in the treatment solution is extracted from the test tube (93) to avoid contamination from the external environment.

15. A medical-surgical kit for collecting, transporting and processing biological or analogous samples to be analyzed, comprising a device (1) for collecting and transporting biological or analogous samples to be analyzed according to any one of claims 1 to 9, the device being equipped with an extraction device (6) capable of extracting a portion of a solution containing the sample or the like from the collection compartment (2), and a test tube (93) connectable to the extraction device (6), the test tube (93) being suitable for collecting and processing the obtained solution and for extracting the sample contained in the processed solution.

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