• 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:
    System for the auto-collection of samples and associated procedure in which the system is made up of a certain case, a self-collection instrument of samples and a unit of drying material and absorbent of transfer of samples. In such a way that the associated procedure begins with the self-collection of a biological sample by means of the aforementioned self-collection instrument, then the extracted biological remains are conveniently deposited in a unit of drying material, which is introduced into a cabin. Enabled in the aforementioned box. Afterwards, this case is housed in a defined package, which transports the sample to the appropriate analysis department, in which they analyze the remains deposited in the drying material unit and return the results of the tests carried out to the sample taker. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2649029A1
    申请号:ES201630932
    申请日:2016-07-08
    公开日:2018-01-09
    发明作者:Jose Luis SUARES PASTOR
    申请人:Ampligen Diagnosticos S L U；Ampligen Diagnosticos SLU；
    IPC主号:
    专利说明:

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    SYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE
    DESCRIPTION
    System for the self-collection of samples and associated procedure.
    OBJECT OF THE INVENTION
    The invention is designed so that a person can take on their own any biological sample from their own body such that epithelial cells from the mouth, nostrils, cervix, urethra or anorectal cavity, through a system or set of elements adapted in each case for the self-collection of samples, in order to detect and identify the DNA itself or possible infectious microbial or microbial agents through an associated procedure by which once the sample is taken it is transported, examined and returned. results to the sample taker.
    The invention is made up of a system consisting of a specific case, a sample self-collection instrument and a unit of drying and absorbent material and unit for the transfer and transport of samples. In such a way that the procedure associated with the said system, starts with the self-taking of a biological sample by means of the mentioned self-collection instrument, then the extracted biological remains are conveniently deposited in the support that allows the transport of the samples , which is introduced in a room enabled in the aforementioned case. Subsequently, this case is housed in a defined package, which transports the sample to the appropriate analysis department, in which they analyze the remains deposited in the drying material unit and return the results of the tests performed to the policyholder.
    sample.
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    The field of application of the invention is comprised within the sector of self-sampling for the individual genetic study and the systematic detection of pathogenic agents for effective health control.
    BACKGROUND OF THE INVENTION
    Over the last few years, technological development and biomedical research has produced spectacular advances in the field of health. That is why, at present there is an increasing number of companies that offer testing services based on genetic and molecular techniques, such as diagnostic tests that indicate a predisposition to common disorders, tests of risk profiles to addiction. , nutrigenomic tests, pharmacogenomics and personal identification or ancestry tests.
    On the other hand, sexually transmitted diseases caused by bacteria or viruses such as papillomavirus are controlled by cervical cancer prevention programs. In all these cases, the sampling programs or processes for the detection and study of biological remains are carried out by qualified personnel trained for this purpose, and the speed of their detection is also essential for a correct and effective treatment. That is why there are many statistical studies carried out in order to verify that fast and efficient mechanisms could help to obtain a reliable diagnosis and at the same time efficient in comfort as is the case of the cars, so that it reaches the greatest number of possible people.
    The initial doubts that arose in this regard were about the quality of the sample obtained by the interested party, compared to the quality of the sample obtained by duly trained health personnel, but numerous scientific studies endorsed that this quality is similar in both scenarios and Importance lies in the conditions of manipulation of the sampling, conservation and transport of the sample.
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    After doing a study of the state of the art in this regard, different records have been found among which we have highlighted the patent registration ES2227864T3 entitled "Device for collecting and examining samples" and the patent registration ES2273715T3 entitled "Apparatus for obtaining biological samples". In both cases, a device or device is presented for the collection and inspection of biological samples for later study, but in these devices or devices the person who takes the biological sample is a trained doctor or professional, while with the device for self-examination. Collection of samples object of the present invention, the biological sample taker is the person who wishes to make the sample. Ace! therefore, the inconvenience of many people who for personal or work reasons do not have time or means to move to a medical center, disappears, since the necessary periodic or specific tests of study can be carried out, in a comfortable and efficient way in addition to the associated procedure from the taking to the information of the derived results.
    On the other hand, we also highlight the ES2568434T3 register entitled “Sampling system” because it is considered closer to the state of the art. In this case the sampling is carried out by means of an instrument or device that allows the person to take the biological sample, this instrument is roughly constituted by a flexible axis that has a handle at one end and that is composed of protrusions and some grooves where the gynecological sample is deposited. That is why this record is totally different from the device for the self-collection of samples and associated procedure object of the present invention, since with the device of the invention the biological samples are first collected by means of an element of sterile adhesive and / or exfoliating material. depending on the type of sample to be collected, and then transferred to a specific drying unit, which protects the integrity of the deposited nucleic acids, the existence of bumps and grooves for the deposit of the biological sample, as well as the object of the invention being nonexistent. the existence of an axis
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    flexible with a dimension such that it is necessary to use a handle at one end, among others.
    It is for all this, that with the system for the self-collection of samples and associated procedure object of the present invention, a further step is taken in the field of self-sampling for the individual identification and systematic detection of agents pathogens, since it presents a system capable of taking different types of biological samples in a simple and effective way, in addition to painless for the person who uses it, with a quality and characteristics different from what is known today.
    Next, a detailed description of the invention is completed that completes these general ideas introduced at this point.
    DESCRIPTION OF THE INVENTION
    The system of the invention is made up of a specific case, a sample self-collection instrument and a sample transfer unit. In such a way that the associated procedure begins with the self-taking of a biological sample by means of the aforementioned self-collection instrument, then the extracted biological remains are conveniently deposited in a unit of drying material, which is introduced into a room enabled in the mentioned case. Subsequently, this case is housed in a defined package, which transports the sample to the appropriate analysis department, in which they analyze the remains deposited in the drying material unit and return the results of the tests performed to the sample taker, as we will see then.
    The sample self-collection instrument is located inside a case, which contains it conveniently adjusted by tightening or similar in its contour so that said instrument or element does not suffer any type of
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    movement within it, thus being immovable. The aforementioned self-collection instrument is formed by a hollow cannula or short tube inside which there is a plunger that contains a stick topped by sterile adhesive and / or exfoliating material with which the different samples are properly collected.
    The types of biological samples that a person can perform as well! same with the system object of the invention and associated procedure, are samples from the mouth, throat, nose, eyelids, samples of anus, rectum, vagina, cervix and penis.
    That is why the self-collection instrument that constitutes the system can acquire different configurations to facilitate the collection of the different samples, depending on the area and pathogens to be analyzed; the preferred configurations of this self-collecting instrument being the so-called swab and the so-called convex, indicating that the convex configuration may have a hole or central cavity at its end for the adequate exit and subsequent entry of a liquid inside.
    As previously mentioned, this self-collection instrument is constituted by a cannula that, in the case of the so-called stick configuration, has its two open end planes and in the case of the convex configuration, one of the ends has a surface curved out and the other end is preferably closed.
    Specifically in the configuration of the swab, inside the said cannula there is a sample collection element, such as a swab of sterilized material and a suitable length, which is located inside such that this swab it moves longitudinally avoiding undue manipulation. In one of the ends that the aforementioned stick has, the sample is collected by friction with vertical movements, of
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    axial rotation or vibration. Thus, through the bristles of sterile material as a brush, swab, exfoliating material, adhesive or the like, it is impregnated with biological material.
    It is noted that the bristles indicated in solidarity with the movement of the so-called swab can be manual, through an element perpendicular to the swab or crossbar which is fixed at the opposite end of the sample and allows the extraction and movement of the bristles of sterile material over the sample collection area; or mechanically, through an electric or electronic motor located inside the cannula and that transmits the aforementioned movement of friction to the stick mechanically by an axis adjustable by a speed reducing device.
    Similarly, with the convex configuration of the self-collection instrument, the sample of biological material is also taken by friction through said sterile material, preferably exfoliating and / or adhesive material, which is located on the curved surface towards outside or convex of the cannula or similar, that is, in this case the zone of impregnation of biological material is located on the outer surface of the short or cannula tube. In this way the impregnation of the sample is obtained on the sterile material also by vertical movements, axial rotation or vibration, but on the outer surface of sterile material thereof. This action can also be manual or mechanical.
    As indicated above, the convex configuration of the biological material self-collection instrument admits a hole or central cavity at its end. In this configuration, the cannula collects the biological material on its inner surface, that is, inside the cannula or short tube, it is extracted by pressing a plunger through the aforementioned central gap, such that the area or cavity body from which the biological sample is obtained, it is filled with the aforementioned liquid to be later collected again inside
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    of the cannula, once the sterile liquid has been impregnated with biological remains. This introduction inside the cannula is done manually by the action of a spring or spring located between the plunger and one of the end faces of the cannula that is closed.
    Once the system for the self-collection of biological samples and the set of elements that make it up is described, it is necessary to define the different steps that make up the associated procedure for its correct use.
    As previously mentioned, the associated procedure begins with the self-taking of a biological sample by means of the self-collection instrument, according to the area of the body that is the object of the analysis. This collection is carried out by means of the smear or friction of the sterile material such as brush bristles, swabs, exfoliating, adhesive or similar material on the area that is susceptible to obtaining the sample. Once the biological material is collected by said sterile material, regardless of the configuration of the self-collection instrument, the extracted biological remains are conveniently deposited in a unit of drying and absorbent material. This unit that protects the integrity of the nucleic acids contained therein, is introduced into a room enabled in the aforementioned case that is part of the system of the invention.
    Another detail of the invention is that the said unit of drying material, due to its configuration and particularities, allows the manipulation and transport of a potentially infectious sample, reducing the health risks of the people who must handle it.
    Then, this case with the unit of drying and absorbent material inside, is housed inside a defined transport package. This package contains printed on its surface the shipping address of the analysis center, analysis department or similar, and also a unique identification
    Park an alphanumeric code, bar code or similar in such a way that the sample holder has a unique code with each auto-collection system used.
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    Finally, after transporting the shipping package as a whole, the biological remains deposited in the drying material unit are analyzed to obtain the individual genetic profile or for the identification of pathogenic agents contained in it or for its use in the genotyping of the same. taker Subsequently, the results obtained are returned to the sample taker, who has initially registered in a certain web portal with their data and the unique identification of their self-collection system. That is why the results of the tests carried out are sent to the policyholder by postal mail and / or through the aforementioned web portal.
    To complete the description that is being carried out and in order to help a better understanding of the characteristics of the invention, a set of drawings is attached as an integral part of it, where the following has been represented by way of illustration and not limitation:
    Figure 1 is a representation of the system set for the self-collection object of the invention.
    Figure 2 is a representation of the sample self-collection instrument of Figure 1, in its configuration of a hand swab, when it is protected inside the cannula.
    Figure 3 is a representation of Figure 2 with the stick coming out of one end of the cannula in the position of collecting the biological sample.
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    Figure 4 is a representation of the sample self-collection instrument of Figure 1, in its configuration of a stick for mechanical use in the position of collection of the biological sample.
    Figure 5 is a representation of the sample self-collection instrument of Figure 1, in a convex configuration.
    Figure 6 is a representation of the sample self-collection instrument of Figure 1, in a convex configuration with a hole or central cavity at its extraction end and collecting a sterile liquid inside.
    Figure 7 is a representation of a package where the case with the biological sample collected by the system of the invention is introduced.
    Figure 8 is an illustration of the mode of use suitable for using the sample self-collection system and associated method of the invention.
    DESCRIPTION OF THE DRAWINGS
    The system of the invention is made up of a specific case (1), a sample self-collection instrument (2) and a unit of drying material (3) and absorbent for the transport of samples (Fig. 1).
    This sample self-collection instrument (2) is located inside said case (1), which contains it conveniently adjusted by tightening or similar in its contour so that said instrument does not suffer any movement within it, being thus immovable. Said self-collection instrument (2) is formed by a cannula (21) or hollow short tube, a stick (22) plunger (221), and sterile material (23) adhesive and / or exfoliating with which they are properly collected The different samples.
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    The types of biological samples that a person can perform as well! same with the system object of the invention and associated procedure, are samples from mouth, nose, eyelids, anus, vagina, cervix and penis.
    That is why the self-collection instrument (2) that constitutes the system can acquire different configurations to facilitate the collection of the different samples, depending on the area to be analyzed; the preferred configurations of this self-collection instrument being the so-called stick (Fig. 2, 3 and 4) and the so-called convex (Fig. 5 and 6), indicating that the convex configuration may have a hole or central cavity (25 ) at its end for proper exit and subsequent entry of a liquid inside.
    In the case of the stick configuration (Fig. 2 and 3), the self-collection instrument (2) is constituted by a cannula (21) open in its two extreme planes (211 and 212) that collects the biological material object to analysis, by means of a certain swab (22) that is located inside it longitudinally, such that this swab (22) moves through the interior of said cannula (21) until it comes into contact with the analysis surface . At this end the swab (22) has bristles of sterile material (23) as a brush, swab, exfoliating, adhesive or similar material that is impregnated with biological material by means of a friction movement on the area to be analyzed such vertical movements, of axial rotation or vibration.
    It is noted that the bristles of sterile material (23) indicated in solidarity with the movement of the stick (22) can be manual (Fig. 2), through a crossbar (223) or element perpendicular to the stick (22) which is located fixed at the opposite end of the sample and allows the extraction and movement of the bristles of sterile material (23) over the sample collection area; or mechanical (Fig. 4), through an electric or electronic motor located inside the cannula (21) and transmitting said friction movement to the
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    stick (22) mechanically by an axis adjustable by a speed reducing device.
    Similarly, with the convex configuration of the self-collection instrument (2) (Fig. 5), the sample of biological material is also taken through friction through said sterile material, preferably exfoliating and / or adhesive material (231 ), which is located on the curved outward or convex surface (24) of the cannula or similar, that is, in this case the impregnation zone of biological material is located on the outer surface of the short or cannulated tube (21) . In this way the impregnation of the sample is obtained on the sterile material also by vertical movements, axial rotation or vibration, but on the curved or convex end (24) of the cannula. This action can also be manual or mechanical through an engine located inside the cannula (21).
    As previously mentioned, the convex configuration admits a hole (25) or central cavity at its end for the adequate exit and subsequent entry of a sterile liquid containing the cannula (21) inside its walls (Fig. 6) . In this configuration, the cannula (21) collects the biological material that has been suspended in the sterile liquid inside the cannula (21) or hollow short tube. This sterile liquid (26) has had to be previously expelled by pressing a plunger (221) through said central hole (25), so that the area or body cavity from which the biological sample is intended to be filled is filled with the aforementioned Sterile Liquid, so that later both the Liquid and the biological remains are collected again inside the cannula (21). This introduction to the interior of the cannula (21), is done manually by the action of a spring (27) or spring located between the plunger (221) and one of the external faces of the cannula that is closed. It is noted that said plunger (221) has the same arrangement of the rod (22) and the crossbar (223) previously mentioned, but an element perpendicular to the base is introduced
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    (222) closer to the convex zone, with equal section to the cylinder walls on which it travels longitudinally.
    Once the system for the self-collection of biological samples and the set of elements that make it up is described, it is necessary to define the different steps that make up the associated procedure for its correct use.
    As previously mentioned, the associated procedure begins with the self-taking of a biological sample by means of the appropriate self-collection instrument (2) according to the body area to be analyzed (step a). This collection is done by smear or friction of the sterile material (23) bristles by way of brush, swab, exfoliating material, adhesive (231) or the like on the area that is susceptible to obtaining the sample.
    Once the biological material is collected by said sterile material (23), regardless of the configuration of the self-collection instrument (2), the extracted biological remains are conveniently deposited by transfer in a unit of drying material (3) ( step b). This unit, which protects the integrity of the nucleic acids contained therein, is introduced into a room enabled in the case (1) previously mentioned that is part of the system of the invention.
    Then, this case (1) with the unit of drying and absorbent material (3) housed inside it, is introduced inside a defined transport package (4) (step c). This package (4) contains printed on its surface the shipping address of the analysis center (41), analysis department or the like, and also a unique identification (42) such as an alphanumeric code, bar code or similar in such a way that The sample holder has a unique code with each self-collection system used (Fig. 7).
    Finally, after transporting the shipping package (4) as a whole, the biological remains deposited in the drying material unit (3) are analyzed to obtain the genetic profile of the policyholder itself, or for the identification of pathogenic agents contained in it. for use in the genotyping of the taker himself (step d). For all this, and in order to facilitate the appropriate mode of use
    To carry out both the self-collection and the shipment of the sample obtained with biological remains, the system for the self-collection object of the present invention incorporates an illustration or leaflet with the indications for use inside of each case (Fig. 8) .
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    For all of which, and once each of the steps indicated has been followed, the results obtained are returned to the sample holder (step e) that initially has been registered in a certain web portal with its data and the unique identification of its system of self-collection. That is why the results 15 of the tests performed reach the policyholder by postal mail and / or through the
    cited web portal.
    Described sufficiently in what precedes the nature of the invention, taking into account that the terms that have been drafted in this specification should be taken in a broad and non-limiting sense, as! as the description of the mode
    of putting it into practice. And, demonstrating that it constitutes a positive technical advance, it is for which the patent registration is requested, being what constitutes the essence of the aforementioned invention what is specified below in the following claims.
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    权利要求:
    Claims (3)
    [1]
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    1- SYSTEM FOR SELF-COLLECTION OF SAMPLES so that a person can take any biological sample from their own body such as mouth, nostrils, anus, cervix or similar that is CHARACTERIZED by being made up of a case (1 ) containing a self-collection sample instrument (2) and a unit of drying material (3) that protects the integrity of nucleic acids, all being immovable inside, and in which the self-collection instrument (2) is constituted by a cannula (21) or hollow short tube, a swab (22) and sterile material (23) with which the different samples are collected.
    2- SYSTEM FOR SELF-COLLECTION OF SAMPLES according to claim 1 that is CHARACTERIZED because the self-collection instrument (2) has a stick configuration and is formed by a stick (22) that is located longitudinally inside a cannula ( 21) that travels along it longitudinally through the two open ends of said cannula (21), and at one end of said stick (22) there are bristles of sterile material (23) as a brush that it is impregnated with biological material by means of a friction movement on the analysis area in solidarity with the movement of the stick (22).
    3 - SYSTEM FOR SELF-COLLECTION OF SAMPLES in which the friction movement according to claim 1 and 2 is CHARACTERIZED because it is manual through the movement of a crossbar (223) or element perpendicular to the stick (22), which is located fixed at the opposite end of the sample.
    4 - SYSTEM FOR SELF-COLLECTION OF SAMPLES in which the friction movement according to claim 1 and 2 is CHARACTERIZED because it is
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    mechanically through an engine located inside the cannula (21) and that transmits the aforementioned friction movement to the stick (22) mechanically by an axis adjustable by a speed reducing device.
    5- SYSTEM FOR SELF-COLLECTION OF SAMPLES according to claim 1 that is CHARACTERIZED because the self-collection instrument (2) has convex configuration and is formed by a cannula (21) that at one of its ends has a convex shape (24) , the area of impregnation of biological material being the outer surface of the short tube or cannula (21) which is where the sterile material (23) is located.
    [6]
    6.- SYSTEM FOR SELF-COLLECTION OF SAMPLES in which the friction movement according to claim 1 and 5 is CHARACTERIZED because it is manual.
    7 - SYSTEM FOR SELF-COLLECTION OF SAMPLES in which the friction movement according to claim 1 and 5 is CHARACTERIZED because it is mechanical through an engine located inside the cannula (21).
    8- SYSTEM FOR SELF-COLLECTION OF SAMPLES according to
    claim 1 that is CHARACTERIZED because the self-collection instrument (2) has a hole (25) or central cavity on an outward or convex curved surface (24) that has the cannula at one of its ends, where it leaves and enters a sterile liquid that is contained inside the said cannula (21) by the action of a spring (27) located in a plunger (221) inside the cannula and that exerts pressure on the liquid.
    9- SYSTEM FOR SELF-COLLECTION OF SAMPLES according to
    claim 1, 2, 3 and 8 that is CHARACTERIZED because the plunger (221) has the configuration of a stick (22) as a central element, a crossbar (223)
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    configuration of a stick (22) as a central element, a crossbar (223) at one of its ends and an element perpendicular to the base (222) with equal section to the inner walls of the cannula (21) on which it travels.
    [10]
    10.- SYSTEM FOR SELF-COLLECTION OF SAMPLES according to claim 1, 2 and 5 that is CHARACTERIZED because the sterile material is a swab.
    11- SYSTEM FOR SELF-COLLECTION OF SAMPLES according to claim 1, 2 and 5 that is CHARACTERIZED because the sterile material is exfoliating.
    12 - SYSTEM FOR SELF-COLLECTION OF SAMPLES according to claim 1, 2 and 5 that is CHARACTERIZED because the sterile material is adhesive.
    13 - ASSOCIATED PROCEDURE FOR SELF-COLLECTION OF SAMPLES so that a person can pick up any biological sample from his own body and manipulate it in a way that protects the integrity of the sample that is CHARACTERIZED because it starts with the self- taking a biological sample by means of a self-collection instrument (2) by smear or friction of a sterile material (23) over the area is susceptible to obtaining the sample (step a); then, the biological material collected is deposited by transfer in a unit of drying and absorbent material (3) (step b), which is introduced into a room arranged in a case (1) which in turn is introduced into a package (4) transport (step c).
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    同族专利:
    公开号 | 公开日
    ES2649029B1|2018-07-30|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US4635488A|1984-12-03|1987-01-13|Schleicher & Schuell, Inc.|Nonintrusive body fluid samplers and methods of using same|
    WO1994004078A1|1992-08-25|1994-03-03|Epitope, Inc.|Oral collection device and kit|
    WO1996001890A1|1994-07-11|1996-01-25|Elias Hakalehto|A syringe comprising an adhering substrate for microbes|
    WO2005082254A2|2004-02-23|2005-09-09|Ethicon, Inc.|Diagnostic swab and biopsy punch systems, and diagnostic caps for use in such systems|
    WO2009073155A2|2007-11-29|2009-06-11|Ameditech, Inc.|Fluid sample collecting and analyzing apparatus|
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