JP2014083386A - Instrument for collecting and moving biological substance sample and method for using the same - Google Patents

Abstract

An object of the present invention is to provide a sampling device and a sampling device capable of avoiding undesired breakage of a shaft portion of a sampling device for collecting and moving a biological material sample and capable of cutting the shaft portion only under specific and limited conditions. Provide usage.
A collection device for collecting and moving a biological material sample, comprising a support having at least a first end and a gripping portion, and a flocking process suitable for collecting a large amount of biological material sample. A plurality of fibers arranged and attached to the first end of the support by flocking so as to form an applied collection part, the support comprising at least a polyamide (PA or nylon), in particular a polyamide 66 (PA66 or nylon 66). The support is provided with at least one fragile portion so as to selectively cut the support and to separate the collection portion from at least a part of the gripping portion.
[Selection] Figure 5

Description

  The present invention relates to a collection device for collecting and moving a biological material sample. Furthermore, the present invention relates to a method for manufacturing and using the sampling device, and a method for collecting and moving a biological material sample using the sampling device.

  This collection device is used, for example, to collect and move a biological material sample directly from an opening of a human body, specifically a human mouth or nostril, and after collecting and moving the biological material sample For example, it is used to enable storage, transportation, and / or analysis of biological material samples.

  2. Description of the Related Art Conventionally, various types of collection instruments for collecting and moving specimens such as organic substances or biological substances are known for use in clinical tests performed analytically or diagnostically as an example.

  For example, as is well known, there is a cotton swab configured to wrap a cotton fiber around the end of the rod to form a collection portion suitable for absorbing the sample collected therein. . While this type of instrument can hold a sample inside the collection section, only a small portion of the held sample is released during analysis.

  In addition, a flocked swab having a long and narrow support body, in which a large number of fibers are flocked so as to form a collection part for collecting a specimen or biological sample at the end of the support body is known (Patent Document). 1). This flocked swab can release a significantly higher proportion of absorbed biological sample.

Japanese Patent No. 4579902 JP 2012-164252 A

  However, since both the cotton swab and the flocked swab described above usually have an elongated rod formed of a flexible material such as polystyrene, they may be accidentally broken during use. It has been a problem that the sample is damaged when the sample is collected from the opening of the human body.

  Also, as a cotton swab that is easy to break the rod, it has a predetermined cutting point that allows the rod to be cut accurately at a predetermined position so that only the sampling part can be stored or transported without leaving the gripping part. Things are also known.

  On the other hand, in Patent Document 2, the shaft portion is provided so as to have greater flexibility and a radius of curvature of 4 mm, preferably 3 mm or 2 mm or less so that the problem of unexpected breakage can be prevented. A flocked swab made of a material that does not break when bent is disclosed.

  The main object of the present invention is to solve one or more of the problems found in the prior art described above.

Another object of the present invention is to provide a method and apparatus for collecting and moving a biological material sample as described below.
(1) Exhibit wide applicability and applicable to a wide variety of applications.
(2) Undesirable breakage of the rod can be avoided.
(3) The rod can be cut only under specific and limited conditions.
(4) Controlled cutting of the rod only at one or more precisely set positions is possible.
(5) Very easy to use and handle.
(6) High level of reliability and safety during use.
(7) Since it is simple, it can be implemented inexpensively.

  The objects set forth above and those arising from what is described below can be substantially achieved by methods and apparatus as defined in one or a combination of one or more claims of the present invention. it can.

  The collection device for collecting and moving the biological material sample of the present invention is provided with a support having at least a first end and a gripping part, and a flocking process suitable for collecting a large amount of biological material sample. A plurality of fibers arranged and attached to the first end of the support by flocking so as to form a collection part, the support comprising a polyamide (PA or nylon), in particular polyamide 66 ( PA66 or nylon 66).

  The support of the sampling device of the present invention can be bent without folding until the radius of curvature reaches at least 5 mm, 4 mm, 3 mm, 2 mm or 1 mm, and / or the support is at an ambient temperature of about 25 ° C. Thus, it is also preferable to be configured so that it can be bent without bending even if it is bent at 90 ° in the opposite direction at least 10, 20, 50, 100, or 200 times.

  The support of the sampling device of the present invention is provided with at least one weak part so that the support can be selectively cut and the sampling part can be separated from at least a part of the grip part. Configured to be selectively cut by bending the support to have a radius of curvature of at least 10 mm, 6 mm, 4 mm, 2 mm or 1 mm and / or 90 °, 60 °, 40 °, 20 ° Configured to be selectively cut by fully bending the support itself at least once or once at an angle of less than 10 ° or 5 °, or the weakened portion is 90 °, 60 ° Selective cutting is possible when the support is bent into a fully bent state at least once or once at an angle less than °, 40 °, 20 °, 10 ° or 5 ° The effect of lever As occurs, it is also preferred that two side walls formed by the fragile portion is configured to contact each other.

  The support of the sampling device of the present invention is provided with at least one weak part so that the support can be selectively cut and the sampling part can be separated from at least a part of the grip part. Configured to prevent selective cutting when the support is bent to a radius of curvature greater than 1 mm, 2 mm, 4 mm, 6 mm or 10 mm and / or 2 °, 5 °, 10 °, 20 ° or It is also preferable that a selective cutting is not caused when the support itself is fully bent at least once or once at an angle greater than 30 °.

  The support of the sampling device of the present invention is provided with at least one weak part so that the support can be selectively cut and the sampling part can be separated from at least a part of the grip part. The diameter of the cross section perpendicular to the longitudinal direction of the support is configured to be reduced by at least 0.1 mm, at least 0.2 mm, at least 0.4 mm, at least 0.8 mm, or at least 1 mm, and / or the weakened portion , Configured to reduce the diameter of the cross section perpendicular to the longitudinal direction of the support by at least 5%, at least 10%, at least 20%, at least 30%, at least 40% or at least 50%, and / or the weakened portion Exhibits a substantially circular shape with a radius of curvature of less than 2 mm, 1 mm or 0.5 mm, or the weakened portion has a concave shape to facilitate cutting. Or at least 0.6 times the width of the weakened portion on the surface of the support, at least 0.8 times its width, and at least equal to its width. Or at least 1.2 times its width or at least 1.5 times its width.

  The fragile part of the sampling device of the present invention is formed by injection molding of the support, or formed by cutting the material of the support after forming the support, and / or the fragile part is supported by the support, gripping Formed in the middle part between the part or the gripping part and the sampling part, and / or the weak part is formed in the vicinity of the sampling part, and / or the weak part is 10 mm to 100 mm from the end of the flocked part, It is also preferably formed at a position 15 mm to 90 mm or 20 mm to 80 mm apart.

  The longitudinal length of the support of the sampling device of the present invention is 50 mm to 200 mm, 100 mm to 200 mm, 145 mm to 155 mm, 148 mm to 152 mm, or 149 mm to 151 mm, and / or perpendicular to the longitudinal direction of the support. The diameter of the cross section is 0.8 mm to 5 mm, 1 mm to 4 mm, 2 mm to 3 mm, 2.3 mm to 2.7 mm or 2.4 mm to 2.6 mm, and / or the support, consistent with the gripping part Further comprises an intermediate connection, the diameter of the cross section perpendicular to the longitudinal direction is 0.5 mm to 3 mm, 1 mm to 2 mm, 1.1 mm to 1.5 mm or 1.2 mm to 1.4 mm, and / or The length of the flocked sampling part is 3 mm to 40 mm, 13 mm to 22 mm, 15 mm to 20 mm or 16 mm to 19 mm and / or The diameter of the cross section including the length of the fiber perpendicular to the longitudinal direction of the processed sampling part is 2 mm to 7 mm, 3 mm to 6 mm, or 4.5 mm to 5.5 mm, and / or the first end The diameter of the cross section perpendicular to the longitudinal direction of the part is also preferably 1 mm to 6 mm, 2 mm to 5 mm, or 3.5 mm to 4.5 mm.

The flocked collection part of the collection device of the present invention substantially collects a known amount of sample, or collects a sample in an amount of 5 μL to 1000 μL, 10 μL to 500 μL, 50 μL to 200 μL, or 80 μL to 120 μL. is configured to, and / or at least 0.5 [mu] L / mm ^2, at least 0.6μL / mm ^2, so obtaining a sample of at least 0.7μL / mm ² or at least 0.75μL / mm ² amount And / or the fibers are disposed substantially aligned on the first end of the support so as to form a substantially continuous layer on the harvesting portion, and / or Or it is also preferable that the fibers are arranged in the collection part so as to form a large number of capillary gaps that facilitate the absorption of the sample by capillary action.

The fiber fineness of the sampling device of the present invention is in the range of 1-7 Dtex or 1.7-3.3 Dtex, and / or the fiber length is in the range of 0.2 mm-3 mm or 0.6 mm-2 mm. And / or the material of the fiber is polyamide (PA or nylon), a material selected from the group consisting of rayon, polyester, carbon fiber, alginate and natural fiber, or a mixture of these materials And / or the fiber is attached to the first end using a vinyl adhesive and / or the support is formed by injection molding or extrusion and / or harvested The density of the fibers on the part is also preferably 50 to 500 or 100 to 200 per 1 mm ² .

  A method for collecting and moving a biological material sample using the sampling device of the present invention, wherein a sampling part flocked to the sampling device is inserted into an opening of a human body, and a sampling device having a support is provided. A step of collecting a biological material sample in the flocked collection unit, a step of holding the sample in the collection unit for a certain period, and / or a step of releasing the biological material sample from the collection unit so that the sample can be analyzed. It consists of.

  The invention in a further embodiment is a method for manufacturing a harvesting device according to any of the claims, which method comprises supporting a harvesting device comprising at least one first end. At least a step of manufacturing a body and a step of applying a large number of fibers to the first end portion by flocking. The method further comprises the step of forming at least one fragile portion in the support by injection molding of the support or forming the support and then cutting the material of the support.

  The invention in a further embodiment, as described in the claims, from the human body and / or openings of the human body, in particular the oral cavity, pharynx, nasal cavity, eyes, urethra, vagina, anus, rectum or skin etc. The present invention relates to a method of using a device for collecting a biological material sample.

According to the present invention, it is possible to provide a method and instrument for collecting and moving a biological material sample having excellent effects as described below.
(1) Exhibit wide applicability and applicable to a wide variety of applications.
(2) Undesirable breakage of the rod can be avoided.
(3) The rod can be cut only under specific and limited conditions.
(4) Controlled cutting of the rod only at one or more precisely set positions is possible.
(5) Very easy to use and handle.
(6) High level of reliability and safety during use.
(7) Since it is simple, it can be implemented inexpensively.

It is a front view of the collection instrument concerning a first embodiment of the present invention. It is a perspective view of the collection instrument shown in FIG. It is an expanded axial sectional view of the III-III part which shows the flock processing part and weak part in the extraction instrument shown in FIG. It is a perspective view of the collection instrument which abbreviate | omitted the flock processing part which concerns on 2nd embodiment of this invention. FIG. 5 is an enlarged view of (A) AA and BB portions and (B) an enlarged view of a fragile portion in the sampling device shown in FIG. 4. It is the front view of the extraction instrument which abbreviate | omitted the (A) flock processing part which concerns on 3rd embodiment of this invention, and (B) is an enlarged view of a weak part.

  One or more preferred embodiments of the present invention are described in detail below, but are not limited to the following examples.

  A collection tool 1 for collecting and moving a biological material sample in one or more embodiments of the present invention will be described. As shown in FIGS. 1 to 6, the collection device 1 for collecting and moving a biological material sample includes a support 2, and the support 2 has an elongated shape and / or a substantially rod-like shape. The cross-sectional shape of the support 2 may be any shape, and may be configured such that the cross-sectional shape changes along the longitudinal direction. Examples of the cross-sectional shape of the support 2 include a circle and an ellipse, or other shapes depending on the purpose.

  In the present invention, the support 2 is made of polyamide (PA or nylon), particularly polyamide 66 (PA66 or nylon 66). The support 2 can be bent without bending until at least the radius of curvature reaches 5 mm, 4 mm, 3 mm, 2 mm, or 1 mm. In addition, the support 2 can be bent without bending even if it is bent at 90 ° in the opposite direction at least 10, 20, 50, 100, or 200 times at an environmental temperature of about 25 ° C. .

  The support body 2 includes a first end 2a, an intermediate portion 2b, and a second end 2c. The first end 2a is, for example, an end that forms a sampling portion 3 for collecting a sample, the intermediate portion 2b is a substantially rod-shaped central portion, and the second end 2c is gripped by a user's hand. It can be connected to another gripping means such as a cap such as a test tube. The sampling unit 3 is configured to be suitable as a swab for wiping a sample.

  The sampling part 3 is formed by flocking (electrostatic flocking) a large number of fibers 6 on the first end 2a of the main body. Either the hydrophilic material or the non-hydrophilic material may be used for the fiber 6 that is flocked to the first end portion 2a. However, in either case, the sampling portion 3 has the characteristics of the fiber 6 and Hydrophilicity is exhibited by capillary action due to the distribution of the fibers 6 on the support 2. That is, the sampling unit 3 forms a continuous layer of fibers 6 made of a material that is substantially absorbable or non-absorbable with respect to the sample, and a large number of capillary gaps in which a predetermined amount of sample is aligned. The sample is absorbed and held in 9, and thereafter the sample can be quantitatively discharged at an appropriate time by pressing or rubbing the collection part 3 against an appropriate discharge surface.

  By the flocking coating, a continuous and uniform layer is formed at the end of the sampling device 1 by a number of regularly arranged fibers, and each fiber is located at any point of the first end 2a of the support 2. Are arranged substantially vertically and substantially parallel to the adjacent fibers 6. Due to the regular alignment of the plurality of capillary gaps 9 formed between the fibers 6, a predetermined amount of sample can be collected and held, including the absorption action due to capillary action. The layer of fiber by flocking can then be effectively removed from the sample collected by, for example, rubbing on an appropriate surface or dipping in an appropriate diluent to release the sample into the diluent. . The flocked sampling part 3 can be configured in a form and size so that an appropriate amount of sample, for example, 5 μL to 1000 μL, 10 μL to 500 μL, 50 μL to 200 μL or 80 μL to 120 μL of sample can be collected. .

The fibers 6 are arranged on the support 2 in a regular alignment so as to form a substantially continuous layer in the collection part 3 and / or a number of suitable for absorbing the sample by capillary action. It arrange | positions on the extraction | collection part 3 so that the capillary gap | interval 9 may be formed. The fineness of the fiber 6 is 1 to 7 Dtex or 1.7 to 3.3 Dtex, and / or the length of the fiber 6 can be in the range of 0.2 mm to 3 mm or 0.6 mm to 2 mm. As for the fiber density of the fiber arrange | positioned by the flock process on the extraction | collection part 3 of the support body 2, 50-500 or 100-200 is preferable per 1 mm < ² > of the surface of the 1st end part 2a of the support body 2. FIG. For example, the fiber 6 can be bonded to the support 2 using a vinyl adhesive 11.

Layer of fibers, for example, a surface 1 mm ² per support 2, at least 0.5 [mu] L / mm ^2, at least 0.6μL / mm ^2, at least 0.7μL / mm ² or at least 0.75μL / mm ² amount of It can be formed to have an absorption capacity. The fibers can be formed of a material that is substantially non-hydrophilic or non-absorbable to the sample and / or a material that is sufficiently hydrophilic or absorbent to the sample, and / or Alternatively, it can be formed of a material selected from the group consisting of polyamide (PA or nylon), rayon, polyester, carbon fiber, alginate and natural fiber, or a material obtained by mixing these materials. The fiber 6 is preferably made of nylon.

  The length in the longitudinal direction of the sampling device 1 or the support 2 is 50 mm to 200 mm, 100 mm to 200 mm, 145 mm to 155 mm, 148 mm to 152 mm or 149 mm to 151 mm, and / or the thickness of the sampling device 1 or the support 2. Alternatively, the diameter of the cross section perpendicular to the central axis is preferably 0.8 mm to 5 mm, 1 mm to 4 mm, 2 mm to 3 mm, 2.3 mm to 2.7 mm, or 2.4 mm to 2.6 mm. The support 2 further has an intermediate connection part 2b, and the diameter of the cross section perpendicular to the longitudinal direction is 0.5 mm to 3 mm, 1 mm to 2 mm, 1.1 mm to 1.5 mm, or 1.2 mm to 1.4 mm. It is preferable that

  The length of the sampling part 3 in the longitudinal direction is 3 mm to 40 mm, 13 mm to 22 mm, 15 mm to 20 mm, or 16 mm to 19 mm, and / or the diameter or thickness of the sampling part 3 including the fibers 6 is 2 mm to 7 mm. It is 3 mm-6 mm or 4.5 mm-5.5 mm, or the diameter of the cross section orthogonal to the longitudinal direction of the 1st end part 2a shall be 1 mm-6 mm, 2 mm-5 mm, or 3.5 mm-4.5 mm Can do. The sampling unit 3 can have an appropriate shape, for example, a round shape, or can have one or more live edges according to the state of the sample to be collected and the collection location.

  The support 2 can be provided with a weakened portion 4 or a break point for facilitating selective cutting of the support 2 in an intermediate portion 2b between the first end 2a and the second end 2c. . Accordingly, for example, the first end 2a and the second end 2b can be easily inserted into the transport container, or the sampling unit 3 can be easily inserted. Thus, by providing the weak part 4, it becomes easy to selectively cut | disconnect the support body 2 and isolate | separate the collection part 3 from at least one part of the holding part 2b.

  The weakened portion 4 can be configured to be selectively cut by bending the support 2 until it reaches a radius of curvature of at least 10 mm, 6 mm, 4 mm, 2 mm or 1 mm. Further, the weakened portion 4 is selectively formed by completely bending the support 2 itself at an angle smaller than 90 °, 60 °, 40 °, 20 °, 10 ° or 5 ° at least once or once. It can comprise so that it can cut | disconnect. Further, the fragile portion 4 is a support body in a state in which the support body 2 itself is completely bent at an angle smaller than 90 °, 60 °, 40 °, 20 °, 10 °, or 5 ° at least once or once. The two side walls 5 formed by the weakened portions 4 can be configured to contact each other so that when the 2 is bent, a lever effect that enables selective cutting is provided. Further, the fragile portion 4 can be configured such that selective cutting does not occur when the support 2 is bent to a radius of curvature greater than 1 mm, 2 mm, 4 mm, 6 mm, or 10 mm. Further, the weakened portion 4 is selected at least once or once when the support 2 is bent at an angle larger than 2 °, 5 °, 10 °, 20 ° or 30 ° and the support 2 itself is completely bent. It is possible to configure so that a typical cutting does not occur.

  The fragile portion 4 can be configured to reduce the diameter of the cross section perpendicular to the longitudinal direction of the support 2 by at least 0.1 mm, at least 0.2 mm, at least 0.4 mm, at least 0.8 mm, or at least 1 mm. . Moreover, the weak part 4 is comprised so that the diameter of the cross section orthogonal to the longitudinal direction of the support body 2 may be reduced by at least 5%, at least 10%, at least 20%, at least 30%, at least 40%, or at least 50%. be able to.

  In order to facilitate cutting, is the depth 8 of the fragile portion at least 0.6 times the width 10 of the fragile portion on the surface of the support 2, at least 0.8 times the width 10, and at least equal to the width 10? , At least 1.2 times the width 10 or at least 1.5 times the width 10. The weakened portion may have a substantially circular shape having a radius of curvature smaller than 2 mm, 1 mm, or 0.5 mm. Further, the fragile portion 4 may be formed in a concave shape to have at least one live edge 7 or at least two live edges 7 for facilitating cutting.

  The fragile portion 4 can be formed by, for example, injection molding of the support 2. Moreover, as another aspect, the weak part 4 can also be formed by the cutting process which cuts the material of the support body 2 after forming the support body 2, or can also be finished. The fragile portion 4 can be formed on the support 2, the gripping portion 2 c, the intermediate portion 2 b between the gripping portion 2 c and the sampling portion 3, and / or can be formed in the vicinity of the sampling portion 3. Moreover, the weak part 4 can be formed in the position spaced apart 10 mm-100 mm, 15 mm-90 mm, or 20 mm-80 mm from the edge part of a flock processing part.

  The sampling device 1 includes a plurality of supports 2, and each support 2 can have a sampling part 3 having a different structure or form so that a sample can be sampled on a special sampling receiving surface, or a certain amount. The sample can be configured to be collected. Furthermore, the sampling instrument 1 can also be provided with a sample transport container having an internal storage portion and an opening. This transport container (not shown because it has a known configuration) may be a test tube for carrying a biological material sample or a biological sample. Moreover, the collection instrument 1 can be provided with a closing lid that can be attached to and detached from the opening so that the container can be arbitrarily closed. The transport container and / or closing lid may be, for example, a resin material such as polystyrene, polystyrene, or polypropylene, and / or a material suitable for use for a specific sample to be collected, or a biological material sample or a biological sample. In general, it can be made of any suitable material for use in The transport container and / or closure cap and / or support 2 can be sterilized. Further, the sampling device 1 can be provided with a hermetic packaging container (not shown because it is a known configuration), whereby the support 2 and / or the transport container and the closing lid are placed in the hermetic packaging container before sampling. Can be stored. The support 2, the hermetic packaging container, the transport container, and the closing lid can be sterilized.

  The invention further relates to a method of using a collection device for collecting a biological material sample from a human body or an opening of a human body, in particular, the oral cavity, pharynx, nasal cavity, eye, urethra, vagina, anus, rectum or skin of the human body. A method of using an instrument for taking a sample from is provided. The present invention also provides a method for producing the sampling device 1 described above.

  Since the method for manufacturing the sampling device 1 according to the present invention includes the following known manufacturing steps, detailed description thereof is omitted. That is, the support 2 is formed by using, for example, injection molding or extrusion molding using polyamide (PA or nylon), particularly polyamide 66 (PA 66 or nylon 66), suitable for the first end 2a of the support 2 A step of applying an adhesive 11, a step of attaching fibers 6 to the first end 2 a by flocking in an electromagnetic field, and an adhesive with a suitable dryer to at least partially polymerize the adhesive The process consists of drying.

  The present invention further provides a method of collecting and moving a biological material sample using the collection device 1 having the above-described configuration. This method includes at least a step of collecting a sample on at least the flocked collection part 3 of the collection instrument 1 by inserting the flocked collection part 3 of the collection instrument 1 into an opening of a human body, for example. I have. This method can further include a step of holding the sample attached to the collection unit 3 for a predetermined time. Further, this method may include a step of dehydrating or drying at least the collection part 3 to which the collected sample is attached. The drying step is performed, for example, by a known method suitable for drying with a dryer, forced ventilation, or other sample processing. This method may further include a step of putting the collection unit 3 in a vacuum vessel (not shown because it has a known configuration) and making the inside of the vacuum vessel a substantially vacuum state. The process of making a vacuum state may be performed simultaneously with the drying process, or may be performed separately from the drying process. Further, this method includes a step of rehydrating the sample on the collection unit 3 by using, for example, a rehydration solution so that a predetermined amount of the rehydrated sample is obtained in the collection unit 3. Also good.

  In addition to this method, the step of inserting the sampling part 3 to which the sample is attached into a container such as a test tube, closing the container with a cap or a closing lid, and moving the container containing the sampling part 3 and / or the sample In order to liquefy / dissolve the sample in a predetermined amount of a substance suitable for liquefaction of the sample, and / or to liquefy / dissolve the sample, the container containing the sampling part 3 to which the sample is attached is stirred, shaken, or You may add the process to rotate.

  This method may further include a step of releasing the biological material sample from the collection unit 3 in order to enable analysis of the sample. This method comprises the step of releasing at least 80%, at least 85% or at least 90% of the collected biological material sample, in particular by using a dilution or dilution buffer in the liquid region to subject the sample to further processing. Can be provided. The sample can be easily released by rubbing the sampling part 3 as in the prior art.

  The present invention has the following advantageous effects. First, the present invention can provide a method for solving the problems of the prior art, a sampling device for practicing this method, and a method using this sampling device. In particular, according to the present invention, it is possible to realize a flox swab that can be widely used and can be easily applied to various types of applications. The present invention also avoids undesirable rod breakage in the swab and allows the rod to be cut only at very specific set conditions and at one or more precisely set positions. In addition, the sampling device 1 according to the present invention can be used very easily, and can enjoy high reliability and stability during use. Furthermore, since the present invention has a simple structure, it can be implemented at low cost.

  The present invention is not limited to the above-described embodiments and examples, but includes various modified designs within the technical scope without departing from the gist of the invention described in the claims. .

DESCRIPTION OF SYMBOLS 1 Sampling instrument 2 Support body 2a 1st end part 2b Middle part (intermediate connection part)
2c Gripping part (second end)
DESCRIPTION OF SYMBOLS 3 Sampling part 4 Fragile part 5 Side wall 6 Fiber 7 Live edge 8 Depth of weak part 9 Capillary gap 10 Width of weak part 11 Adhesive

Claims (10)

A collection device for collecting and moving a biological material sample,
A support having at least a first end and a gripping portion;
A plurality of fibers disposed and attached by flocking to the first end of the support so as to form a flocked sampling part suitable for collecting a large amount of biological material sample; Comprising at least
A sampling device characterized in that the support is made of polyamide (PA or nylon), in particular polyamide 66 (PA66 or nylon 66).   The support can be bent without folding until the radius of curvature reaches at least 5 mm, 4 mm, 3 mm, 2 mm or 1 mm, and / or the support is in the opposite direction at an ambient temperature of about 25 ° C. The sampling device according to claim 1, wherein the sampling device is configured so that it can be bent without bending even if it is bent at 90 ° at least 10, 20, 50, 100, or 200 times. . The support is provided with at least one fragile portion so as to selectively cut the support and to separate the sampling portion from at least a part of the gripping portion.
The weakened portion is configured to be selectively cut by bending the support to have a radius of curvature of at least 10 mm, 6 mm, 4 mm, 2 mm, or 1 mm, and / or 90 °, 60 °, Configured to be selectively cut by fully bending the support itself at least once or once at an angle of less than 40 °, 20 °, 10 ° or 5 °, or the fragile The support was bent in a state where the support itself was fully bent at least once or once at an angle smaller than 90 °, 60 °, 40 °, 20 °, 10 ° or 5 °. In this case, the two side walls formed by the weakened portions are configured to contact each other so as to produce a lever effect that enables selective cutting. Described Preparative instrument. The support is provided with at least one fragile portion so as to selectively cut the support and to separate the sampling portion from at least a part of the gripping portion.
The fragile portion is configured so that selective cutting does not occur when the support is bent to a radius of curvature greater than 1 mm, 2 mm, 4 mm, 6 mm, or 10 mm, and / or 2 °, 5 °, 10 ° A structure in which selective cutting does not occur when the support itself is fully bent at least once or once at an angle greater than °, 20 °, or 30 °. The collection instrument of any one of 1-3. The support is provided with at least one fragile portion so as to selectively cut the support and to separate the sampling portion from at least a part of the gripping portion.
The weakened portion is configured to reduce the diameter of a cross section perpendicular to the longitudinal direction of the support by at least 0.1 mm, at least 0.2 mm, at least 0.4 mm, at least 0.8 mm, or at least 1 mm, and / or Alternatively, the weakened portion is configured to reduce the diameter of a cross section perpendicular to the longitudinal direction of the support by at least 5%, at least 10%, at least 20%, at least 30%, at least 40%, or at least 50%. And / or the weakened portion has a substantially circular shape with a radius of curvature of less than 2 mm, 1 mm or 0.5 mm, or the weakened portion has a concave shape, at least for facilitating cutting. Have one live edge, or the depth of the weakened portion is at least 0.6 times the width of the weakened portion on the surface of the support. 5. The width according to claim 1, wherein the width is at least 0.8 times, at least equal to the width, at least 1.2 times the width, or at least 1.5 times the width. Collection tool.   The fragile portion is formed by injection molding of the support, or formed by cutting the material of the support after forming the support, and / or the fragile portion is the support, Formed in the gripping part or an intermediate part between the gripping part and the sampling part, and / or the weakened part is formed in the vicinity of the sampling part, and / or the weakened part is formed in the flocked part. The sampling device according to any one of claims 3 to 5, wherein the sampling device is formed at a position 10 mm to 100 mm, 15 mm to 90 mm, or 20 mm to 80 mm away from the end.   The longitudinal length of the support is 50 mm to 200 mm, 100 mm to 200 mm, 145 mm to 155 mm, 148 mm to 152 mm, or 149 mm to 151 mm, and / or the diameter of the cross section perpendicular to the longitudinal direction of the support is , 0.8 mm to 5 mm, 1 mm to 4 mm, 2 mm to 3 mm, 2.3 mm to 2.7 mm, or 2.4 mm to 2.6 mm, and / or the support further The diameter of the cross section provided with the intermediate connection portion and orthogonal to the longitudinal direction is 0.5 mm to 3 mm, 1 mm to 2 mm, 1.1 mm to 1.5 mm or 1.2 mm to 1.4 mm, and / or flocking The length of the collected portion is 3 mm to 40 mm, 13 mm to 22 mm, 15 mm to 20 mm, or 16 mm to 19 mm, and / or the flow. The diameter of the cross-section including the length of the fiber perpendicular to the longitudinal direction of the processed sampling portion is 2 mm to 7 mm, 3 mm to 6 mm, or 4.5 mm to 5.5 mm, and / or The diameter of the cross section orthogonal to the longitudinal direction of 1 edge part is 1 mm-6 mm, 2 mm-5 mm, or 3.5 mm-4.5 mm, The collection instrument of any one of Claims 1-6 characterized by the above-mentioned. . The flocked collection part substantially collects a known amount of the sample, or is configured to collect the sample in an amount of 5 μL to 1000 μL, 10 μL to 500 μL, 50 μL to 200 μL, or 80 μL to 120 μL. are, and / or at least 0.5 [mu] L / mm ^2, at least 0.6μL / mm ^2, configured to collect the sample of at least 0.7μL / mm ² or at least 0.75μL / mm ² amount And / or the fibers are disposed on the first end of the support in a substantially aligned manner to form a substantially continuous layer on the harvesting portion; And / or wherein the fibers are arranged in the sampling part so as to form a large number of capillary gaps that facilitate the absorption of the sample by capillary action. Collecting instrument according to 5. The fineness of the fibers is in the range of 1-7 Dtex or 1.7-3.3 Dtex, and / or the length of the fibers is in the range of 0.2 mm-3 mm or 0.6 mm-2 mm, and / or The fiber material is polyamide (PA or nylon), a material selected from the group consisting of rayon, polyester, carbon fiber, alginate and natural fiber, or a mixture of these materials. And / or the fibers are attached to the first end using a vinyl adhesive and / or the support is formed by injection molding or extrusion and / or The density of the said fiber on a collection part is 50-500 or 100-200 per 1 mm < ² >, The collection instrument of any one of Claims 4-6 characterized by the above-mentioned. A method for collecting and moving a biological material sample using the collection device according to any one of claims 1 to 9,
A step of collecting a biological material sample in the flocked sampling part of the sampling device having the support by inserting the flocked sampling part of the sampling device into an opening of a human body;
Holding the sample in the collection part for a certain period, and / or
And a step of releasing the biological material sample from the collection unit so that the biological material sample can be analyzed.

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