• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    device for collecting, transferring and/or preserving samples of biological material. device for collecting (1), transferring and/or preserving samples of biological material, wherein the device (1) comprises at least: a support body (2) provided with at least one housing plate (3) for an element storage (4) for samples of biological material, in particular a paper for preserving samples of biological material, wherein the housing plate (3) is configured to allow to releasably house the preserving element (4) for samples of biological material, the support body (2) is configured to keep at least a preservation portion (5) of the preservation element (4) accessible to deposit a sample of biological material when the preservation element (4) is housed in the housing plate (3); an operating part (6), movable between at least a first closed position in which it is arranged in the vicinity of said housing plate (3) and at least one open position in which it is placed in a position distanced from the housing plate ( 3); and engaging means (7) configured to selectively and detachably engage a sampling element (8) for samples of biological material, in particular a buccal sampling element or a buccal swab, to the holder (2) and/or the part. operational (6). (fig. 5)
    公开号:BR112014032484B1
    申请号:R112014032484-0
    申请日:2013-06-14
    公开日:2021-06-15
    发明作者:Daniele Triva
    申请人:Copan Italia S.P.A.；
    IPC主号:
    专利说明:

    [001] This invention concerns an application for the collection, transfer and/or conservation of samples of biological material.
    [002] The invention further relates to a method for collecting, transferring and/or preserving samples of biological material through the device and a use of the device for collecting, transferring and/or preserving samples of biological material. The invention is, in particular, applicable to the collection, transfer and/or conservation of oral or lingual samples.
    [003] The use is known of conventional sampling devices provided with at least a collection part capable of collecting biological samples and a support body allowing the manipulation of the collection element.
    [004] The pick-up devices are known to be provided with pick-up parts of several different types, for example consisting of cotton fibers wound on a rod, or an absorbent material of a spongy or foamy type placed on a rod, etc.
    [005] Also known are devices known as "flocculated swabs", comprising an elongated support body and a series of flocculated fibers at one end of the support body in order to define a collection part for the analyzes or biological samples. This type of device is known from patent EP1608268 (TRIVA).
    [006] It is still known, after having collected the sample of biological material, how to transfer the biological sample to a different support that can allow to conserve the biological sample even for a long period of time. For example, it is known to collect samples through the collection devices on matrix supports or chemically treated papers so as to allow the absorption and preservation of samples of biological material. This type of paper is known, for example, from patent application WO9003959 (BURGOYNE).
    [007] Also known are devices that allow the collection of the biological sample and its transfer to papers for conservation through a simple device, which comprises both the sample element and a support for the paper. This device, known for example from patent application W02008/099196 (HARVARY et al), comprises a connecting part between the collecting element and the paper support, which connecting part can be bent after executing the sample in order to place the collection part of the collection element in contact with the paper, and effecting the transfer of the sample of the collected biological material to the paper.
    [008] This solution allows to guarantee the traceability of the collected sample, as the collection element and the respective paper, housed in the support solidly enclosed to the device, can be kept together, without the possibility of transfer error.
    [009] The device described above exhibits, however, some drawbacks. In fact, as it is a single device, it is difficult to handle to use to collect the sample, as the operator has to constantly manipulate the entire device during sample collection, including the support body, not just the element. of pickup. This is especially difficult in the typical case of device use, i.e. where a buccal sample has to be collected inside a patient's mouth. Furthermore, this leads to the risk of contamination of the paper housed in the holder body during manipulation of the device for collecting the sample.
    [010] The main objective of this invention is to prevent one or more of the problems found in the prior art.
    [011] An objective of this invention is to provide a device and a method for collecting, transferring and/or preserving samples of biological material, easy to use and carry out.
    [012] Another objective of this invention is to provide a device and method for collecting, transferring and/or preserving samples of biological material that allows a reduction in the risk of contamination of the collected samples.
    [013] Another objective of this invention is to provide a device and a method for collecting, transferring and/or preserving samples of biological material that allows the traceability of the collected samples.
    [014] Another objective of this invention is to make available a device and a method for collecting, transferring and/or preserving samples of biological material of simple and economical execution.
    [015] These objectives and others in addition to these, which will appear in their entirety in the description that follows, are significantly achieved by a device and a method for collecting, transferring and/or preserving samples of biological material in accordance with the provisions of a or more of the accompanying claims, considered alone or in conjunction with one another, or in any combination with one or more of the additional aspects described below.
    [016] In another aspect, the invention further relates to a device for collecting, transferring and/or preserving samples of biological material according to any of the appended claims, and/or additional aspects indicated herein, further comprising at least an identification tag or other identifying element.
    [017] In a further aspect, the invention further relates to a device according to any of the accompanying claims, and/or the additional aspects indicated herein, in which a housing plate for a preservation element for sample biological material is configured as a lateral opening of a support body into which the preserving element in the form of paper is inserted by sliding.
    [018] In another aspect, the invention further relates to a method according to any of the accompanying claims, and/or additional aspects indicated herein, further comprising a step of distancing the collection part of the collection element of the preservation part of the preservation element in order to place the device for collecting and transferring samples of biological material in a preservation and/or transport position.
    [019] In another aspect, the invention further relates to a method according to any of the accompanying claims, and/or the additional aspects indicated herein, further comprise the step of preserving the sample of biological material in the part of storage of the preservation element for an extended period of time and/or with the device for collecting and/or preserving samples of biological material configured in a storage or transport position.
    [020] In a further aspect, the invention further relates to the use of a device according to any of the accompanying claims for collection, transfer and/or preservation of a sample of biological material and/or for oral collection, transport and preserving a sample of oral biological material.
    [021] Through a non-limiting example, a description of one or more preferred models of the invention follows, in which:
    [022] Figure 1 is a front perspective view of a support body and a mobile operating part of a device according to an embodiment of this invention, in an open configuration;
    [023] Figure 2 is a rear perspective view of the support body and the mobile operating part of Figure 1;
    [024] Figure 3 is a device according to an embodiment of this invention in an open position, with a recoil element not coupled with the engaging means of the operating part;
    [025] Figure 4 illustrates a device of Figure 3 with the pick-up element coupled with engaging means of the operating part;
    [026] Figures 5 and 6 illustrate a device of Figure 4 in two respective intermediate positions between an open position and a closed position;
    [027] Figure 7 is the device of Figure 4 in a closed position;
    [028] Figure 8 is a detail of the device of Figure 4 in a first closed position and/or contact and sample transfer position;
    [029] Figure 9 is a detail of the device of Figure 4 in a second closed position and/or storage and transport position of the device;
    [030] Figure 10 illustrates a variant of the device of Figure 3 in an open position, with a recoil element coupled to the engaging means of the operating part;
    [031] Figure 11 illustrates the device of Figure 10 in an intermediate position between an open position and a closed position;
    [032] Figure 12 illustrates an additional variant of the device of Figure 3 in an open position, with a recoil element coupled to the means of engagement of the support body;
    [033] Figure 13 illustrates the device of Figure 12 in a closed position.
    [034] Referring to the figures that accompany the drawings, 1 indicates in its entirety a device for collecting, transferring and/or preserving samples of biological material.
    [035] The device comprises at least one support body 2 provided with at least one housing plate 3 for a conservation element 4 of biological samples. The dish 3 is configured to allow the housing to releasably accommodate the preservation element 4 of the biological samples.
    [036] Preservative element 4 is preferably a chemically treated paper and is suitable for preserving samples of biological material, and is in particular a paper comprising at least one preserving substance for a particularly suitable sample of biological material for the conservation of an oral sample.
    [037] The housing plate 3 can thus be configured to releasably accommodate the chemically treated paper for the conservation of biological samples, and is preferably configured as a side opening of the support body 2 into which the paper is slidably inserted. .
    [038] The support body 2 is configured to keep at least a preservation part 5 of the preservation element 4 accessible to deposit a sample of biological material when the preservation element 4 is housed in the dish 3, for example through the front opening 12, in relation to the side opening.
    [039] The device 1 further comprises an operating part 6 removable at least between a first closed position in which it is placed in the vicinity of the housing plate 3 and at least one open position in which it is placed in a position distanced from the housing plate. accommodation 3.
    [040] Device 1 further comprises engaging means 7 configured to selectively and detachably engage a sample element 8 for samples of biological material to device 1 for the collection and transfer of samples of biological material, and, in particular, for support body 2 and/or operating part 6.
    [041] The sampling element 8 is provided with at least one collection part 9 suitable for sampling biological material, with an elongated body 11 to allow manipulation, and at least one coupling part 10 in which is selectively and detachably coupled 7 to engagement means 7.
    [042] In particular, the element 8 can be a collection device for a buccal sample, or a buccal swab. In this text, “buccal” is taken to mean a collection of an oral sample performed in a patient's mouth, and thus also includes a lingual or similar sample.
    [043] The invention can, however, find its application, in one or more of its aspects, for samples of a type other than the buccal, for example other body cavities, or for the collection of blood samples. In a further embodiment, illustrated in Figures 12 and 13, the engagement means 7 can be configured to selectively or detachably engage the sampling element 8 to the support body 2 and/or directly executed on the support body 2 in the vicinity of the housing plate 3, so that the collection part 9 is located in the conservation part 5.
    [044] Furthermore, the engagement means 7 can be used to define at least a first mounting position of the sampling element 8 in which contact occurs and a transfer of the biological material is made between the collection part 9 and the conservation 5. The engagement means 7 are also capable of defining at least a second mounting position of the collection element in which the collection part 9 is spaced apart from the conservation part 5 and, thus, there is no contact and transfer of the biological material between the collecting part 9 of the sampling element 8 and the preserving part 5, the second mounting position further defining a storage storage and/or storage transport position of the device 1.
    [045] In the models illustrated in Figures 1 to 11, the engaging means 7 are configured to selectively and detachably engage the collection element 8 for biological material samples to the operating part 6, so that the sampling element 8 is selectively portable, as a result of displacement of the operating part 6 in the housing 2 and the preserving part 5 in the first closed position and/or such that the collecting part 9 is selectively portable in the housing 3 and/or in contact with the conservation part 5 in the first closed position.
    [046] The device may further comprise closure means 13 to selectively close the device 1 at least in the first closed position, illustrated in detail in Figure 8, in which preferably a contact and transfer of biological material between the part occurs. 9 and the holding part 5. The closure means 13 can preferably also define at least a second closed position, illustrated in detail in Figure 9, in which the holding part 9 is distanced from the holding part 5 and, in this way, there is no contact and transfer of biological material between the two parts, the second closed position advantageously also defining a storage and/or transport position of the device 1.
    [047] The operating part 6 may comprise a closing element 14, or lid, capable of at least in the first closed position and/or in the second closed position to at least partially cover the housing plate 3 and/or at least partially cover and to protect the preservation element 4 for biological material samples housed in the housing plate 3 and/or to cover and protect the preservation part 5 for biological material samples during storage and/or transport of the device and/or at least in the second closing position and/or at least in the second mounting position.
    [048] The operating part 6 can be non-removably engaged with the support body 2, for example, it can be made in one piece with the support body 2. In a variant the operating part 6 can be releasably engaged to the support body 2.
    [049] In the models illustrated in the accompanying figures, the operating part 6 is joined to the support body 2 through an elastically deformable connecting part 15. In a variant, the connecting part 15 can be elastically deformable. At least the support body 2, the operating part 6, the engaging means 7, the connecting part 15, the sampling element 8 and/or the coupling part 10 are preferably made of plastic material. For example, the support body 2, the operating part 6, the engaging means 7 and the connecting part 15 can be of polypropylene, while the sampling element 8 and/or the coupling part 10 can be of polystyrene.
    [050] The engagement means 7 may for example include a support 16 into which the coupling part 10 of the sampling element 8 is selectively insertable by sliding and/or pressing and/or rotation, or in any other suitable way. to the end.
    [051] Also, and alternatively, a coupling bracket can be provided on the sampling device and a coupling pair 7 on the coupling means. The engagement means 13 can comprise at least one coupling part 7 built into the operating part 6 and at least one support with fastening 18 made on the support body 2. Also, and alternatively, a coupling support can be provided in the operating part 6 and an engaging part on the support body 2.
    [052] The closure means 13 may comprise at least two distinct engagement parts 17a, 17b selectively engageable in the bracket with fastening 18, so as to respectively define the first and second closed positions. The closing means 13 may comprise at least two separate fixing brackets 18a, 18b with the engaging part 17 to respectively define the first and second closed positions. In the embodiment of Figures 1-9, the attachment part 17 comprises at least two distinct attachment zones 17a, 17b, each designed to engage with its separate attachment bracket 18a, 18b so as to respectively define the first and second positions closed (shown respectively in figures 8 and 9). In the variant of Figures 10 and 11, the first closed position is defined by a fastening part 17 and a corresponding fastening bracket 18, while the second closed position is instead defined by additional closing elements 20 acting on the operating part 16 and/or on the connecting part 15, defining the second closed position mentioned above (in which the fixing part 17 is not engaged with the fixing bracket 18).
    [053] The device 1 may further comprise a projection element 21 of the operating part 6 capable of acting on the collection part 9 in order to force it into contact with the conservation part 5 and facilitate the transfer of biological material. The device 1 can further comprise at least one identification tag or other identification element 19 which can be provided for example on the support body 2 and/or on the mobile operating part 6, and/or on the preservation element 4, as illustrated. in Figure 2.
    [054] The invention further relates to a method for collecting, transferring and/or preserving samples of biological material through a device 1 of the type described above.
    [055] The method comprises at least the following steps: collecting a sample of biological material in at least a collecting part 9 of a sample element 8, preferably a buccal sample, subsequently selectively coupled to the sampling element 8 with a holder body 2 or with a mobile operating part 6 of the device 1, bringing a part 9 of the sampling element 8 collection in contact with a preservation part 5 of a biological samples preservation element 4 in a holder body 2 of the housing plate 3 in order to transfer a quantity of biological material from the collecting part 9 of the sampling element 8 to the preserving part 5.
    [056] The method may further comprise the step of subsequently distancing the gathering part 9 from the storage part 5 of the preservation element 4 in order to bring the device 1 into a preservation and/or transport position. The method may further comprise the step of keeping the sample of biological material in the preservation part 5 for a period of time, preferably with the device 1 configured in a preservation or transport position.
    [057] The invention also concerns the use of a device 1 of the type described above, for collection, transfer and/or preservation of a sample of biological material and/or for buccal collection, transport and preservation of a sample of oral material biological.
    [058] This invention allows to obtain at least one or more of the following advantages. First, the invention prevents one or more of the problems encountered in the prior art. The invention is also convenient to use and easy to implement, further simplifying the transfer and/or conservation of samples of biological material, especially in the case of oral and therefore lingual samples.
    [059] The invention also reduces the risk of contamination of the collected samples, as the collection element is handled independently and separately from the support body of the preserving element during sample collection. This invention also achieves full traceability of the collected samples, as the collection element can be coupled to the respective conservation element. Finally, the invention is simple and economical to perform.
    权利要求:
    Claims (10)
    [0001]
    1. Device for collecting (1), transferring and preserving samples of biological material, wherein the device (1) comprises at least: a support body (2) provided with at least one housing plate (3), a operating part (6), movable between at least a first closed position in which it is arranged in the vicinity of said housing plate (3) and at least one open position in which it is placed in a position distanced from said housing plate ( 3), engaging means (7) configured to selectively and detachably engage a sampling element (8) for samples of biological material, in particular an element for oral sampling or a buccal swab, to said support (2) and/ or to said operating part (6), characterized in that said housing plate (3) is a housing plate (3) for a preserving element (4) for samples of biological material, which is a role for preserving samples of material biological, being the ref A housing plate (3) configured to allow to releasably house said preservation element (4) for samples of biological material, said support body (2) being configured to hold at least a preservation part (5) of said element. storage (4) accessible for depositing a sample of biological material when the preserving element (4) is housed in said housing plate (3).
    [0002]
    Device according to claim 1, characterized in that it further comprises said sampling element (8) provided with at least one collecting part (9) suitable for collecting samples of biological material and with at least one coupling part (10) in correspondence with which it is selectively and removably coupled to said engagement means (7) and/or wherein said sampling element (8) is a buccal swab provided with an elongated shape comprising at least one body elongate (11) to which said collection part (9) is associated.
    [0003]
    Device according to any one of claims 1 or 2, characterized in that it further comprises said preserving element (4) for samples of biological material and/or wherein said preserving element (4) is a suitable chemically treated paper for preserving samples of biological material or is a paper comprising at least one preserving substance for a sample of biological material.
    [0004]
    Device according to any one of claims 1 to 3, characterized in that said engagement means (7) are configured to selectively or releasably engage said sampling element (8) for samples of biological material to said body of the support (2), in correspondence with said housing plate (3), and/or wherein said engagement means (7) are suitable for defining at least a first mounting position of said sampling element (8) at correspondence with which a contact occurs and a transfer of biological material is effected between a collecting part (9) of said sampling element (8) and said preserving part (5) and/or in which said engaging means (7) are suitable for defining at least a second mounting position of said sampling element (8) in correspondence with which said collecting part (9) is distanced from said preserving part (5) and thus not there is no contact or transfer of biological material between said collecting part (9) and said preserving part (5), said second mounting position further defining a preserving and/or transporting position of said device (1).
    [0005]
    Device according to any one of claims 1 to 4, characterized in that said engaging means (7) are configured to selectively or releasably engage said sampling element (8) for samples of biological material for said part. operational (6), so that said sampling element (8) can be selectively placed in correspondence with said housing plate (3) and said preserving part (5) in said first closed position and/or so that said collecting part (9) can be selectively placed in correspondence with said housing plate (3) and/or in contact with said preserving part (5) in said first closed position.
    [0006]
    Device according to any one of claims 1 to 5, characterized in that it further comprises closing means (13) suitable for selectively closing said device (1) at least in said first closed position and/or wherein, in said first closed position, a contact and transfer of biological material takes place between said collecting part (9) and said preserving part (5) and/or wherein said closing means (13) are suitable to further define at least a second closed position in which said collecting part (9) is distanced from said preserving part (5), thus there is no contact or transfer of biological material between said collecting part (9) and said preserving part (5 ), said second closure part further defining a storage and/or transport position of said device (1).
    [0007]
    Device according to any one of claims 1 to 6, characterized in that said operating part (6) comprises a closing element (14) or cover suitable for at least partially covering said housing plate (3), at least in said first closed position and/or in said second closed position, and/or to cover and protect said preservation part (5) for samples of biological material during preservation and transport of the device (1) at least in said second closed position .
    [0008]
    Device according to any one of claims 1 to 7, characterized in that said operating part (6) is non-removably engaged with said support body (2) or wherein said operating part (6) is executed in a single piece with said support body (2).
    [0009]
    Device according to any one of claims 1 to 8, characterized in that said engagement means (7) comprise a coupling support (16) on which said coupling part (19) of said sampling element (8) is selectively insertable by sliding and/or pressing and/or by rotation, or vice versa, and/or said closing means (13) comprise at least one fastening part (17) executed on said operating part (6) and at least one fastening plate (18) executed on said support body (2), or vice versa, and/or wherein said closing means (13) comprise two distinct fastening parts (17a,17b) selectively engageable to said clamping plate (18), so as to define respectively said first and said second closed positions and/or wherein said closing means (13) comprise at least two clamping plates (18a,18b) executed in the said support body (2) for cooperating with said fastening part (17) or for each cooperating respectively. with one of said fixing parts (17a, 17b), so as to define respectively said first and said second closed positions.
    [0010]
    10. Method for collecting, transferring and/or preserving samples of biological material through a device (1) for collecting, transferring and/or preserving samples of biological material as defined in any one of claims 1 to 9, the method characterized in that it comprises at least the following steps: collection, without surgical steps, of a sample of biological material in at least one collection part (9) of a sample element (8), subsequently selectively coupling the sampling element (8) with a support body (2) or with a mobile operating part (6) of said device (1), for collecting, transferring and/or preserving samples of biological material, subsequently causing a collection part ( 9) of said sampling element contacts a preserving part (5) of a preserving element (4) for samples of biological material housed in a housing plate (3) of the said support body (2) for transferring a quantity of said biological material from said collecting part (9) to said preserving part (5) of said preserving element (4).
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    同族专利:
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    ES2755768T3|2020-04-23|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-05-11| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-06-15| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/06/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    ITMI2012A001120|2012-06-26|
    IT001120A|ITMI20121120A1|2012-06-26|2012-06-26|DEVICE AND METHOD FOR THE COLLECTION, TRANSFER AND / OR CONSERVATION OF SAMPLES OF BIOLOGICAL MATERIAL|
    PCT/IB2013/054870|WO2014001940A1|2012-06-26|2013-06-14|A device for collecting, transferring and/or conserving samples of biological material|
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