JP7408367B2 - Sample collection device, method for manufacturing the sample collection device, and measurement system - Google Patents

Description

The present application relates to a sample collection device, a method for manufacturing the sample collection device, and a measurement system.

Conventionally, for example, a sample collecting device has a plate-like part formed in a plate shape, and the plate-like part has an inner space part into which a liquid sample (e.g., blood) is transferred by capillary action. There is. The inner space section includes a collection port for collecting the specimen, a storage section for storing the specimen inside, and an open port for communicating the storage section with the outside of the plate-shaped section (for example, , Patent Document 1).

In the sample collection device according to Patent Document 1, the open port is connected to the distal end of the storage section. This causes the specimen to be transferred to the distal end of the reservoir. However, in such a configuration, the position of the opening is restricted by the distal end of the reservoir, so there is little freedom in designing the position of the opening.

Japanese Patent Application Publication No. 2009-175118

Therefore, an object of the present invention is to provide a sample collection device, a method for manufacturing the sample collection device, and a measurement system that allow flexibility in designing the position of the opening.

The specimen collection tool includes a main body formed in a plate shape, the main body includes an inner space into which a liquid specimen is transferred by capillary action, and the inner space has a space for collecting the specimen. a collection port, a storage section that stores the specimen inside, a deterrent section that is connected to the distal end of the reservoir section and that prevents the specimen from being transferred from the reservoir section, and an exterior of the deterrent section and the main body section. and an open opening for communicating with the main body, and in the thickness direction of the main body, the size of the restraining part is larger than the size of the distal end of the storage part.

Further, in the specimen collecting device, the internal space portion may be configured to include a step between the storage portion and the restraining portion.

Further, in the specimen collecting device, the inner space portion includes a buffer portion having the restraining portion and the open opening and capable of accommodating the specimen, and the main body portion includes a plate-shaped portion formed in a plate shape. , a protruding part that protrudes from the first surface of the plate-shaped part in the thickness direction and has the sampling port at the tip, and the internal space part is formed inside the protruding part from the sampling port in the thickness direction. A configuration may also be adopted in which an extending transfer section is provided, and the volume of the buffer section is larger than the volume of the transfer section.

Further, in the specimen collecting device, the inner space section includes a buffer section that has the restraining section and the open opening and can accommodate the specimen, and the main body section stores at least a portion of the specimen in the storage section. The device may include a transmitting portion that transmits the water, the transmitting portion is formed in a deformable membrane shape, and the volume of the buffer portion is 30% or more of the volume of the storage portion.

Further, in the sample collecting device, the hydrophilicity of the deterrent portion may be smaller than the hydrophilicity of at least a portion of the storage portion.

Further, the method for manufacturing a specimen collection device is the method for manufacturing the specimen collection device described above, comprising: a base member having a restraining recess that constitutes the restraining portion; a storage opening that constitutes the storage portion; and the restraining portion. preparing a layer member having a deterrent opening constituting the storage opening and a membrane member covering the reservoir opening and the deterrent opening, and so that the deterrent recess and the deterrent opening are connected; The method includes fixing the base member and the layer member, and fixing the layer member and the membrane member so that the membrane member covers the storage opening and the suppression opening.

Further, the measurement system includes the above-mentioned specimen collection device and a measuring device that measures the specimen collected with the specimen collection device.

FIG. 1 is an overall perspective view of a measurement system according to one embodiment. FIG. 2 is an internal view of region II in FIG. 1. FIG. 3 is an overall perspective view of the specimen collection device according to the same embodiment. FIG. 4 is a perspective view of a main part of the sample collection tool according to the same embodiment. FIG. 5 is an overall view of the sample collection device according to the same embodiment, in which (a) is a side view and (b) is a bottom view. FIG. 6 is an enlarged view of the VI region in FIG. FIG. 7 is a sectional view of a main part taken along line VII-VII in FIG. 6. FIG. 8 is an enlarged view of region VIII in FIG. 7. FIG. 9 is an enlarged sectional view taken along line IX--IX in FIG. 7. FIG. 10 is an enlarged cross-sectional view taken along line XX in FIG. 7. FIG. 11 is an enlarged view of the XI region in FIG. FIG. 12 is a cross-sectional view taken at the same position as FIG. 7, and shows the state in which the specimen was collected. FIG. 13 is a cross-sectional view taken at the same position as FIG. 9, and shows a state in which a specimen has been collected. FIG. 14 is a diagram illustrating an example of a method for collecting a sample using the sample collecting tool according to the present embodiment. FIG. 15 is a diagram illustrating another example of the sampling method using the specimen sampling tool according to the present embodiment. FIG. 16 is a diagram illustrating the method for manufacturing the specimen collection device according to the present embodiment, and is a perspective view seen from below. FIG. 17 is a diagram illustrating the method for manufacturing the specimen collection device according to the present embodiment, and is a perspective view seen from below. FIG. 18 is a sectional view of a main part of a sample collection device according to another embodiment. FIG. 19 is a sectional view of a main part of a specimen collecting device according to still another embodiment. FIG. 20 is a cross-sectional view of a main part of a sample collecting device according to still another embodiment. FIG. 21 is an enlarged sectional view taken along line XXI-XXI in FIG. 20.

Hereinafter, one embodiment of a measurement system and a sample collection device will be described with reference to FIGS. 1 to 17. In addition, in each figure (the same applies to Figures 18 to 21), the dimensional ratio in the drawing and the actual dimensional ratio do not necessarily match, and the dimensional ratio between each drawing does not necessarily match. do not have.

As shown in FIG. 1, the measurement system 100 includes a sample collection tool 1 that collects a sample, and a measuring device 101 that measures the sample collected with the sample collection tool 1. Then, the measuring device 101 measures, for example, the concentration of the component in the sample.

Note that the specimen is not particularly limited as long as it is liquid, and examples of the specimen include body fluids such as blood, serum, plasma, saliva, and urine. Furthermore, the components to be measured by the measuring device 101 are not particularly limited, but examples of the components to be measured include glucose, cholesterol, free fatty acids, neutral fats, uric acid, lactic acid, and the like.

As shown in FIGS. 1 and 2, the measuring device 101 includes a measuring device main body 102 having a mounting opening 102a into which the specimen collecting device 1 is attached, a measuring section 103 that measures the specimen, and a measuring device 102 that measures the position of the specimen collecting device 1. It includes a position detecting section 104 for detecting a position, and a specified sample amount detecting section 105 for detecting the amount of a sample (specified amount) in the sample collecting tool 1. Note that the measuring section 103, the position detecting section 104, and the specified sample amount detecting section 105 are each arranged inside the measuring instrument main body 102.

Although the configuration of the measurement section 103 is not particularly limited, in this embodiment, the measurement section 103 includes a contact section 103a that comes into contact with the sample collection tool 1 when measuring a sample, and the contact section 103a has a convex shape. It is formed into a spherical shape. Further, for example, when the specimen is blood and the component to be measured is glucose, the measurement unit 103 includes, for example, an electrode and a treatment membrane covering the electrode.

Specifically, after blood is separated into blood cells and plasma by a blood cell separation membrane provided in the sample collecting device 1, only the plasma that has passed through the blood cell separation membrane is transferred onto the electrode. After glucose in the plasma is converted to hydrogen peroxide by an enzyme reaction membrane coated on the electrode, the amount of hydrogen peroxide is measured on the electrode. That is, the specimen collection tool 1 according to the present embodiment is a specimen collection tool 1 that collects a specimen as a measurement sample through an electrochemical reaction.

The position detection unit 104 detects whether the position of the sample collection tool 1 is appropriate. Although the configuration of the position detection section 104 is not particularly limited, in this embodiment, the position detection section 104 includes a pair of electrodes 104a, 104a. Then, when the position of the specimen collecting device 1 with respect to the measuring device 101 is appropriate, conduction occurs between the pair of electrodes 104a, 104a.

Specimen prescribed amount detection unit 105 detects whether the amount of specimen collected by specimen collection tool 1 is appropriate. Although the configuration of the specified sample amount detection section 105 is not particularly limited, in this embodiment, the specified sample amount detection section 105 includes a pair of electrodes 105a, 105a. Then, when the amount of specimen collected by the specimen collecting device 1 is appropriate, conduction occurs between the pair of electrodes 105a, 105a.

As shown in FIGS. 3 to 6, the specimen collection tool 1 is formed into a long length. The specimen collecting tool 1 includes a main body 2 and a columnar part 3 connected to the main body 2. Further, the main body portion 2 includes a plate-shaped portion 4 formed in a plate shape and a protrusion portion 5 protruding from the plate-shaped portion 4.

In each figure and the following description, the first direction D1 is referred to as the longitudinal direction D1 (of the main body portion 2 and the plate-like portion 4), and the second direction D2 orthogonal to the first direction D1 is referred to as the longitudinal direction D1 (of the main body portion 2 and the plate-like portion 4). , of the plate-like portion 4), and a third direction D3 perpendicular to the first direction D1 and the second direction D2, respectively, is called the thickness direction D3 (of the main body portion 2 and the plate-like portion 4). Note that, depending on the shape of the specimen collection tool 1, the first direction D1 may be the lateral direction, and the second direction D2 may be the longitudinal direction.

The plate-like portion 4 has a first surface 4a facing the first side in the thickness direction D3 (the side facing the arrow in the thickness direction D3 in each figure) and a second side facing the thickness direction D3 (the side facing the arrow in the thickness direction D3 in each figure). and a side circumferential surface 4c that connects the first surface 4a and the second surface 4b. The protruding portion 5 protrudes from the first surface 4a of the plate-like portion 4 in the thickness direction D3. Further, the first surface 4a of the plate-shaped portion 4 is provided with a concave portion 4d around the protrusion portion 5.

The columnar portion 3 is connected to the side peripheral surface 4c of the plate-like portion 4. Specifically, the columnar portion 3 extends from the side peripheral surface 4c of the plate-like portion 4 in the longitudinal direction D1. Further, the dimension of the columnar portion 3 in the thickness direction D3 is larger than the dimension of the plate-like portion 4 in the thickness direction D3.

The columnar portion 3 protrudes from the first surface 4a of the plate-like portion 4 and also from the second surface 4b of the plate-like portion 4 in the thickness direction D3. As a result, the specimen collecting tool 1 has a step between the columnar part 3 and the first surface 4a of the plate-like part 4, and also has a step between the columnar part 3 and the second surface 4b of the plate-like part 4. There is a step in between.

Further, the main body section 2 includes a detected section 2a that is detected by the position detection section 104 (see FIG. 2). Although the configuration of the detected portion 2a is not particularly limited, in this embodiment, the detected portion 2a is a conductor disposed on the second surface 4b of the plate-like portion 4. When the position of the sample collection device 1 with respect to the measuring device 101 is appropriate, the detected part 2a is connected to the pair of electrodes 104a, 104a of the position detection part 104, and conduction is established between the pair of electrodes 104a, 104a. let

Further, the main body section 2 includes a detection circuit section 6 that constitutes a circuit detected by the specified sample amount detection section 105 (see FIG. 2). Although the configuration of the detection circuit section 6 is not particularly limited, in this embodiment, the detection circuit section 6 includes a pair of conductive sections 6a, 6a having electrical conductivity. The conductive portion 6a includes a first terminal 6b disposed in an inner space 7, which will be described later, and a second terminal 6c connected to an electrode 105a of the specified sample amount detection portion 105.

When the amount of the specimen collected by the specimen collecting device 1 is appropriate, the first terminals 6b, 6b of the pair of conductive parts 6a, 6a are electrically connected by the specimen. As a result, the pair of conductive parts 6a, 6a are electrically connected, so that the detection circuit part 6 brings electrical continuity between the pair of electrodes 105a, 105a of the specified sample amount detection part 105.

The main body 2 includes an inner space 7 into which a specimen is transferred by capillary action. The inner space 7 includes a collection port 7a that is open to the outside of the main body 2 to collect a specimen, and an opening 7b that is opened to the outside of the main body 2 to cause capillary action. Note that the inner space portion 7 is open to the outside of the main body portion 2 only through the sampling port 7a and the opening port 7b. Moreover, the inner space part 7 is a concept that includes a surface that constitutes the inner space.

The sampling port 7a is open in the thickness direction D3 of the plate-like portion 4. Specifically, the collection port 7a is arranged at the tip of the protrusion 5. Thereby, the position of the sampling port 7a can be easily recognized.

The opening 7b is arranged on the second surface 4b of the plate-like portion 4. Thereby, the second surface 4b on which the opening port 7b is arranged is a surface opposite to the first surface 4a on which the sampling port 7a is arranged. Therefore, it is possible to prevent the opening port 7b from being mistaken for the sampling port 7a.

The protruding portion 5 includes a truncated conical protruding main body portion 5a and a convex portion 5b that further protrudes in the thickness direction D3 from the tip of the protruding main body portion 5a. A pair of protrusions 5b are provided. The pair of convex portions 5b, 5b are spaced apart in the longitudinal direction D1 so as to form a gap, and are arranged to face each other in the longitudinal direction D1.

As a result, a gap is formed between the protrusions 5b, so that, for example, when the tip of the protrusion 5 comes into contact with the patient's skin, it is possible to prevent the skin from sealing the collection port 7a. can. Therefore, even when the tip of the protrusion 5, that is, the protrusion 5b, is in contact with the patient's skin, blood passes through the gap between the protrusions 5b and is introduced into the sampling port 7a. Note that the number of protrusions 5b is not particularly limited.

Note that the protrusion 5 is formed transparent. Furthermore, the region of the plate-shaped portion 4 that overlaps with the protruding portion 5 in the thickness direction D3 is formed transparent. Specifically, the plate-shaped portion 4 is formed transparent except for the detected portion 2a and the detection circuit portion 6. Thereby, the position of the sampling port 7a can be recognized from the second surface 4b side of the plate-shaped portion 4.

Here, the configuration of the inner space section 7 will be explained with reference to FIGS. 6 to 11.

As shown in FIGS. 6 and 7, the inner space part 7 is connected to a transfer part 7c extending in the thickness direction D3 from the collection port 7a inside the protrusion part 5, and a distal end (downstream end) of the transfer part 7c. , a storage section 7d for storing a sample inside the plate-like section 4, and a buffer section 7e connected to the distal end (downstream end) of the storage section 7d and capable of accommodating the sample. Note that the buffer section 7e includes an opening 7b, and the opening 7b opens the buffer section 7e to the outside of the main body section 2.

The plate-shaped portion 4 includes a first wall portion 4e and a second wall portion 4f that are separated in the thickness direction D3 to form a storage portion 7d. Note that the outer surface of the first wall portion 4e constitutes the first surface 4a of the plate-like portion 4, and the outer surface of the second wall portion 4f constitutes the second surface 4b of the plate-like portion 4. There is.

The second wall portion 4f is configured to allow a portion of the sample in the storage portion 7d (in this embodiment, plasma in blood) to pass therethrough. As a result, the plate-shaped portion 4 includes, on the second surface 4b, a transmitting portion 4g (ie, a second wall portion 4f) through which a portion of the sample in the storage portion 7d is transmitted. Note that the transmitting portion 4g is formed into a deformable membrane shape.

Although the structure of the permeation part 4g is not particularly limited, in this embodiment, the permeation part 4g is a blood separation membrane that allows only plasma to pass through in order to separate blood cells and plasma from blood. That is, although not particularly limited, the specimen collection tool 1 according to the present embodiment does not include a reagent in the internal space 7 that reacts with the specimen (blood).

Further, the transfer portion 7c is connected to the storage portion 7d by passing through the first wall portion 4e of the plate-like portion 4. That is, the first wall portion 4e of the plate-like portion 4 also constitutes the distal end (downstream end) of the transfer portion 7c. By the way, since the first wall part 4e is separated from the second wall part 4f in the thickness direction D3, when the specimen is transferred from the first wall part 4e to the second wall part 4f, for example, the specimen is Transfer speed becomes slower.

Therefore, as shown in FIG. 8, the plate portion 4 includes a guide portion 4h extending from the first wall portion 4e to the second wall portion 4f. The surface of the guide portion 4h is smoothly continuous with the surface of the transfer portion 7c without having any step. Thereby, the guide portion 4h guides the specimen from the first wall portion 4e to the second wall portion 4f, so that the specimen can be smoothly transferred from the transfer portion 7c to the storage portion 7d. Therefore, when the sample is transferred from the first wall portion 4e to the second wall portion 4f, it is possible to suppress the sample transfer speed from becoming slow.

Therefore, as shown in FIG. 9, the transfer section 7c is connected to one end (upstream end) of the storage section 7d when viewed in the thickness direction D3. The open opening 7b is connected to the other end (downstream end) of the reservoir 7d when viewed in the thickness direction D3. Specifically, the other end of the storage section 7d is connected to a buffer section 7e having an open section 7b. Thereby, the sample transferred from the transfer section 7c is transferred from one end of the storage section 7d to the other end, so that the sample can be transferred over the entire area of the storage section 7d.

In the present embodiment, by transferring the sample to the first side in the longitudinal direction D1 (the side in the direction of the arrow in the longitudinal direction D1 in each figure), the sample can be transferred throughout the storage section 7d. That is, there is no need to transfer the specimen to the second side in the longitudinal direction D1 (the side opposite to the direction of the arrow in the longitudinal direction D1 in each figure).

In addition, when viewed in the thickness direction D3, the dimension W1 of the storage portion 7d in the transverse direction D2 (direction orthogonal to the sample transfer direction) increases toward the sample transfer direction (first side in the longitudinal direction D1). It becomes small after that. Thereby, the sample can be transferred more reliably over the entire area of the storage section 7d. Note that the first terminal 6b of the conductive section 6a of the detection circuit section 6 is arranged at the end (downstream end) side of the storage section 7d.

Further, in the storage section 7d, a measurement region 7h where the specimen is measured is a region in contact with the measurement section 103 (see FIG. 2). Although not particularly limited, in the present embodiment, the maximum width W1 of the measurement area 7h is the maximum value of the dimension W1 in the transverse direction D2 of the storage portion 7d.

Further, it is preferable that the distance W2 between the transfer portion 7c and the measurement area 7h is smaller than the maximum width W1 of the measurement area 7h when viewed in the thickness direction D3. According to such a configuration, the amount of specimen required from the transfer section 7c to the measurement area 7h is reduced. Therefore, the amount of specimen required for measuring the specimen can be reduced.

Incidentally, the specimen is normally transported to the opening 7b by capillary action. At this time, since the open port 7b is far from the storage section 7d, a large amount of sample is required to transfer the sample to the open port 7b.

Therefore, as shown in FIGS. 10 and 11, the buffer section 7e includes a deterrent section 7f that prevents the sample from being transferred from the storage section 7d. The deterrent section 7f is connected to the distal end (downstream end) of the storage section 7d. In addition, in FIG. 11, a broken line indicates the boundary between the storage section 7d and the buffer section 7e (suppressing section 7f).

A dimension W3 in the thickness direction D3 of the restraining portion 7f is larger than a dimension W4 in the thickness direction D3 of the distal end portion of the storage portion 7d. Thereby, the inner space part 7 is provided with a step 7g between the restraining part 7f and the storage part 7d. Therefore, it is possible to prevent the sample from being transferred from the storage section 7d to the suppression section 7f due to capillary action. Note that, although not particularly limited, the dimension W3 of the restraining portion 7f is preferably 1.5 times or more, and preferably 2 times or more, the dimension W4 of the distal end of the storage portion 7d, with the step 7g as a boundary. is even more preferable.

Moreover, the hydrophilicity of the deterrent portion 7f is smaller than the hydrophilicity of at least a portion of the storage portion 7d. That is, the hydrophilicity of the deterrent portion 7f (specifically, the average hydrophilicity of the entire deterrent portion 7f) is higher than the hydrophilicity of the reservoir portion 7d (specifically, the average hydrophilicity of the entire reservoir portion 7d). , is getting smaller. Thereby, it is possible to further suppress the sample from being transferred to the deterrent section 7f, and therefore it is possible to effectively prevent the sample from being transferred from the storage section 7d to the deterrent section 7f.

Although not particularly limited, for example, the hydrophilicity of the deterrent portion 7f may be smaller than the hydrophilicity of the entire region of the storage portion 7d. Further, for example, the hydrophilicity of the deterrent section 7f may be smaller than the hydrophilicity of the upstream region of the storage section 7d and the same as the hydrophilicity of the downstream region of the storage section 7d. It is preferable that the hydrophilicity of the region of the storage portion 7d that overlaps with the transfer portion 7c is greater than the hydrophilicity of the restraining portion 7f when viewed in the thickness direction D3.

In this way, even if the opening 7b is located away from the distal end of the storage section 7d, the sample transfer can be stopped at the distal end of the storage section 7d. As a result, even in a configuration in which the sample is transferred only by capillary action without being centrifuged, the position of the open port 7b is not restricted by the end of the storage section 7d, so the design of the position of the open port 7b is It can have a degree of freedom. Note that the opening 7b allows the restraining portion 7f and the outside of the main body portion 2 to communicate with each other.

Next, the function of the buffer section 7e will be explained with reference to FIGS. 12 and 13.

The specimen transferred by capillary action (colored portions in FIGS. 12 and 13) fills the sampling port 7a, the transfer portion 7c, and the storage portion 7d, as shown in FIGS. 12 and 13. By the way, for example, there is a possibility that the sample in the transfer part 7c leaks into the storage part 7d due to the water head caused by the sample in the transfer part 7c.

Therefore, the volume of the buffer section 7e is larger than the volume of the transfer section 7c. Thereby, when the specimen in the transfer part 7c leaks into the storage part 7d, the buffer part 7e can accommodate the specimen leaked from the storage part 7d accordingly. Thereby, even if the sample in the transfer part 7c leaks into the storage part 7d due to the water head caused by the sample in the transfer part 7c, it is possible to suppress the sample from leaking from the open port 7b.

Further, the contact portion 103a (see FIG. 2) of the measuring portion 103 of the measuring device 101 comes into contact with the transparent portion 4g of the plate-like portion 4 of the sample collecting device 1. Since the transmission part 4g is formed in a deformable film shape, when the contact part 103a comes into contact with the transmission part 4g, the transmission part 4g may be deformed and the volume of the storage part 7d may be reduced. . In particular, in this embodiment, the contact portion 103a is formed in a convex spherical shape.

Therefore, the volume of the buffer section 7e is preferably 30% or more, and more preferably 50% or more, of the volume of the storage section 7d. As a result, when the permeable portion 4g is deformed and the volume of the storage portion 7d is reduced, and the sample leaks from the storage portion 7d, the buffer portion 7e is unable to accommodate the sample leaked from the storage portion 7d. can. Therefore, leakage of the sample from the opening 7b can be suppressed.

Next, a method for collecting a specimen using the specimen collecting tool 1 will be described with reference to FIGS. 14 and 15.

First, as shown in FIG. 14, by turning the sampling port 7a downward, a specimen on the surface, for example, blood on the skin, can be sucked up and collected from the sampling port 7a. A region of the plate-shaped portion 4 that overlaps with the protrusion 5 in the thickness direction D3 and the protrusion 5 are formed transparent. Thereby, the position of the sampling port 7a can be easily recognized from the second surface 4b side of the plate-shaped portion 4, and therefore the sample can be easily collected.

Note that the columnar portion 3 may be grasped when collecting the specimen. Since the columnar part 3 is connected to the side circumferential surface 4c of the plate-like part 4, the direction of the sampling port 7a (upward, upward, (downward) can be easily changed. Thereby, for example, it is possible to facilitate the work of collecting a specimen and the work of attaching the specimen collection tool 1 to the measuring machine 101 (see FIG. 1).

In addition, since the sampling port 7a is open in the thickness direction D3, as shown in FIG. etc.) can be collected by sucking it from the collection port 7a.

At this time, even if the sample leaks from the sampling port 7a, the plate-shaped portion 4 can receive the sample. Moreover, since the first surface 4a of the plate-shaped portion 4 includes a recess 4d (see FIG. 3) around the protrusion 5, that is, the sampling port 7a, leaked specimen can be retained in the recess 4d. . Therefore, dripping of the specimen from the specimen collecting tool 1 can be suppressed. In this way, a specimen can be reliably collected using any collection method.

Moreover, since the columnar part 3 protrudes beyond the second surface 4b of the plate-like part 4, the specimen collection tool 1 is placed on the mounting surface X2 with the second surface 4b of the plate-like part 4 facing downward. At this time, the end of the second surface 4b of the plate-like part 4 and the columnar part 3 are supported by the mounting surface X2. Thereby, since the transmission part 4g, which is important for measurement, is separated from the mounting surface X2, it is possible to suppress the transmission part 4g from coming into contact with the mounting surface X2. Note that a configuration may be adopted in which only the columnar part 3 is supported by the mounting surface X2, and the entire second surface 4b of the plate-shaped part 4 is separated from the mounting surface X2.

In addition, since the sampling port 7a is provided not on the first surface 4a of the plate-like part 4 but at the tip of the protruding part 5 that protrudes from the first surface 4a of the plate-like part 4, the area in contact with the specimen can be reduced. can do. Thereby, for example, it is possible to suppress contamination of the measuring device 101 (see FIGS. 1 and 2) with the specimen.

Next, a method for manufacturing the sample collection tool 1 will be described with reference to FIGS. 16 and 17.

Although the number of members constituting the specimen collecting tool 1 is not particularly limited, the specimen collecting tool 1 according to the present embodiment is comprised of three members 11 to 13, as shown in FIGS. 16 and 17. The three members 11 to 13 are a base member 11 that constitutes most of the columnar part 3 and plate-like part 4, a layer member 12 that constitutes a part of the storage part 7d and the restraining part 7f, and a transparent part 4g (the third part). 2 and a membrane member 13 constituting the second wall portion 4f).

The material of the base member 11 is not particularly limited, and may be, for example, synthetic resin (eg, polycarbonate). Further, the material of the membrane member 13 is not particularly limited, but may be, for example, a synthetic resin (eg, polycarbonate) that can permeate plasma from blood.

Note that the surface of the base member 11 that constitutes the transfer section 7c and the storage section 7d is subjected to a hydrophilic treatment, and the surface of the membrane member 13 that constitutes the storage section 7d is subjected to a hydrophilic treatment. Thereby, the transfer of the specimen in the transfer section 7c and the storage section 7d can be facilitated. Note that, although not particularly limited, examples of the hydrophilic treatment include surfactant agents (for example, 29-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-3,6,9,12, 15,18,21,24,27-nonaoxanonacosan-1-ol, polyoxyethylene sorbitan monolaurate, polyoxyethylene lauryl ether, polyvinylpyrrolidone, etc.) can be employed.

The base member 11 includes, for example, a buffer recess 11a forming the buffer section 7e and a guide protrusion 11b forming the guide section 4h on one side. Note that the buffer recess 11a is formed in a concave shape with a bottom, and includes a restraining recess 11c that constitutes the restraining part 7f. The base member 11 also includes a protrusion 5 (not shown in FIGS. 16 and 17) that protrudes from the other surface, and the protrusion 5 has a transfer opening that constitutes the transfer section 7c. 11d.

In addition, since the guide protrusion 11b is provided on the base member 11, regardless of the position of the layer member 12 with respect to the base member 11 (for example, even if the position of the layer member 12 deviates from the proper position), the guide portion The surface 4h continues smoothly with the surface of the transfer portion 7c without any step (see FIG. 8).

Further, the amount of protrusion of the guide protrusion 11b may be larger than the thickness of the layer member 12. Thereby, the guide portion 4h can be reliably brought into contact with the second wall portion 4f of the plate-like portion 4 constituting the storage portion 7d (see FIG. 8).

Furthermore, the layer member 12 includes a storage opening 12a that constitutes the storage section 7d, and a restraining opening 12b that constitutes the restraining section 7f. Note that the storage opening 12a and the suppression opening 12b each penetrate the layer member 12 in the thickness direction. Further, the storage opening 12a is connected to the restraining opening 12b. Further, the material of the layer member 12 is not particularly limited, but may be, for example, a resin having adhesive properties.

Therefore, first, the base member 11, the layer member 12, and the membrane member 13 are prepared (preparation step). Then, since the layer member 12 becomes an adhesive layer, as shown in FIG. 16, the base member 11 and the layer member 12 are fixed by bonding the layer member 12 to the base member 11 (first fixing step ).

At this time, the transfer opening 11d of the base member 11 is connected to the storage opening 12a of the layer member 12. Moreover, the restraining recess 11c of the base member 11 is connected to the restraining opening 12b of the layer member 12. Thereby, the deterrent opening 12b and the buffer opening 11a constitute the deterrent portion 7f, and a step 7g is formed between the deterrent portion 7f and the storage portion 7d. In addition, in FIG. 16, the broken line has shown the boundary between the storage opening 12a and the suppression opening 12b.

Thereafter, as shown in FIG. 17, the layer member 12 and the membrane member 13 are fixed by bonding the membrane member 13 to the layer member 12 (second fixing step). Thereby, the storage opening 12a and the suppression opening 12b of the layer member 12 are covered with the membrane member 13. In this way, the specimen collection tool 1 is manufactured.

Note that the method for manufacturing the sample collection tool 1 is not particularly limited. For example, the sample collection device 1 may be manufactured from one, two, or four or more members. Alternatively, a manufacturing method may be used in which the layer member 12 does not have adhesive properties and the members 11, 12, 13 are fixed to each other with, for example, an adhesive, or by, for example, thermal welding. A manufacturing method in which it is fixed may also be used. Further, for example, the order of fixing the base member 11 and layer member 12 and fixing the layer member 12 and membrane member 13 is not particularly limited.

As described above, the specimen collection device 1 according to the present embodiment includes a main body 2 formed in a plate shape, and the main body 2 includes an inner space 7 into which a liquid specimen is transferred by capillary action. The inner space 7 is connected to a collection port 7a for collecting a sample, a storage section 7d for storing the sample inside, and an end portion of the storage section 7d, and the sample is transferred from the storage section 7d. The size of the deterrent portion 7f in the thickness direction D3 of the main body portion 2 is provided with a deterrent portion 7f for inhibiting the above-mentioned deterrent portion 7f, and an open opening 7b for communicating the deterrent portion 7f with the outside of the main body portion 2. W2 is larger than the dimension W3 of the distal end of the storage portion 7d.

According to such a configuration, the inner space portion 7 includes a restraining portion 7f connected to the distal end portion of the storage portion 7d. In the thickness direction D3 of the main body part 2, the dimension W2 of the restraining part 7f is larger than the dimension W3 of the distal end of the storage part 7d, so that the sample is restrained from being transferred from the storing part 7d to the restraining part 7f. can do. As a result, the position of the opening 7b is not restricted by the distal end of the storage portion 7d, so that there is a degree of freedom in designing the position of the opening 7b.

Moreover, in the specimen collection device 1 according to the present embodiment, the inner space portion 7 is configured to include a step 7g between the storage portion 7d and the restraining portion 7f.

According to this configuration, since the step 7g exists between the storage section 7d and the deterrent section 7f, the step 7g effectively prevents the sample from being transferred from the storage section 7d to the deterrence section 7f. be able to.

Further, in the specimen collection device 1 according to the present embodiment, the inner space section 7 includes a buffer section 7e that has the restraining section 7f and the opening port 7b and can accommodate a specimen, and the main body section 2 , comprising a plate-shaped portion 4 formed in a plate shape, and a protrusion 5 that protrudes from the first surface 4a of the plate-shaped portion 4 in the thickness direction D3 and has the sampling port 7a at its tip, The portion 7 includes a transfer portion 7c extending from the sampling port 7a in the thickness direction D3 inside the protruding portion 5, and the volume of the buffer portion 7e is larger than the volume of the transfer portion 7c. be.

According to such a configuration, the inner space 7 includes the transfer portion 7c extending from the sampling port 7a in the thickness direction D3 inside the protrusion 5, whereas the volume of the buffer portion 7e is equal to or larger than the transfer portion 7c. It is larger than the volume of. Thereby, when the specimen in the transfer part 7c leaks into the storage part 7d, the buffer part 7e can accommodate the specimen leaked from the storage part 7d accordingly.

Further, in the specimen collection device 1 according to the present embodiment, the inner space section 7 includes a buffer section 7e that has the restraining section 7f and the opening port 7b and can accommodate a specimen, and the main body section 2 , a transmission section 4g that transmits at least a part of the sample in the storage section 7d, the transmission section 4g is formed in a deformable membrane shape, and the volume of the buffer section 7e is equal to the volume of the storage section 7d. The composition is 30% or more.

According to this configuration, the main body portion 2 includes a transmission portion 4g that allows at least a portion of the sample in the storage portion 7d to pass through, and the transmission portion 4g is formed in a deformable membrane shape. Since the volume of the buffer section 7e is 30% or more of the volume of the storage section 7d, when the transmission section 4g is deformed, the buffer section 7e can accommodate the sample leaked from the storage section 7d. .

Furthermore, the sample collecting device 1 according to the present embodiment is configured such that the hydrophilicity of the deterrent portion 7f is smaller than the hydrophilicity of at least a portion of the storage portion 7d.

According to such a configuration, since the hydrophilicity of the deterrent section 7f is smaller than the hydrophilicity of at least a portion of the storage section 7d, it is possible to further suppress the specimen from being transferred by the deterrence section 7f. Thereby, it is possible to effectively prevent the sample from being transferred from the storage section 7d to the suppression section 7f.

Further, the method for manufacturing the specimen collection device 1 according to the present embodiment includes a base member 11 having a deterrent recess 11c that constitutes the deterrence portion 7f, a storage opening 12a that constitutes the storage portion 7d, and the deterrence portion 7f. and a membrane member 13 that covers the storage opening 12a and the suppression opening 12b, and the suppression recess 11c and the suppression opening 12b. The base member 11 and the layer member 12 are fixed so that and fixing the membrane member 13.

Note that the sample collection device 1, the method for manufacturing the sample collection device 1, and the measurement system 100 are not limited to the configurations of the embodiments described above, and are not limited to the effects described above. Further, it goes without saying that the sample collection device 1, the method for manufacturing the sample collection device 1, and the measurement system 100 may be modified in various ways without departing from the gist of the present invention. For example, it goes without saying that one or more of the configurations, methods, etc. according to the various modification examples described below may be arbitrarily selected and adopted as the configurations, methods, etc. according to the above-described embodiments.

(1) The sample collection device 1 according to the above embodiment is configured such that the collection port 7a is open in the thickness direction D3 of the main body portion 2. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the sampling port 7a may be opened in directions D1 and D2 perpendicular to the thickness direction D3 of the main body portion 2. Specifically, the sampling port 7a may be arranged on the side circumferential surface 4c of the plate-like portion 4.

(2) Further, the sample collection device 1 according to the above embodiment includes a protrusion 5 that protrudes from the first surface 4a of the plate-shaped portion 4, and the sampling port 7a is arranged at the tip of the protrusion 5. The configuration is as follows. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, a configuration may be adopted in which the protruding portion 5 is not provided and the sampling port 7a is arranged on the first surface 4a of the plate-like portion 4.

(3) Furthermore, in the sample collection device 1 according to the above embodiment, the transfer portion 7c is connected to the end portion of the storage portion 7d when viewed in the thickness direction D3. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the transfer section 7c may be connected to a position away from the end of the storage section 7d (for example, the center of the storage section 7d) when viewed in the thickness direction D3.

(4) Further, in the sample collection device 1 according to the above embodiment, the plate-shaped portion 4 includes a guide portion 4h extending from the first wall portion 4e to the second wall portion 4f, and the surface of the guide portion 4h is The structure is such that it is smoothly continuous with the surface of the portion 7c. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the plate-shaped portion 4 may be configured without the guide portion 4h. Further, for example, the surface of the guide portion 4h may be continuous with the surface of the transfer portion 7c with a step.

(5) Furthermore, in the sample collection device 1 according to the above embodiment, the plate-shaped portion 4 is formed transparent except for the detected portion 2a and the detection circuit portion 6, and the protruding portion 5 is formed transparent. The structure is that However, the sample collection tool 1 is not limited to such a configuration. For example, the plate-shaped portion 4 may have a configuration in which only the region overlapping with the protruding portion 5 in the thickness direction D3 is formed transparent. Further, at least one of the plate-like portion 4 and the protruding portion 5 may be formed to be opaque.

(6) Furthermore, in the specimen collection device 1 according to the above embodiment, the first surface 4a of the plate-like portion 4 is configured to include a recess 4d around the protrusion 5. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the first surface 4a of the plate-shaped portion 4 may be flat over the entire area around the protrusion 5, that is, it may be configured to have no recess 4d.

(7) Furthermore, in the specimen collection device 1 according to the above embodiment, the first surface 4a of the plate-shaped portion 4 is provided with a recess 4d formed by recessing the area around the protrusion 5. However, the sample collection tool 1 is not limited to such a configuration. For example, as shown in FIG. 18, the plate-shaped portion 4 includes an annular convex portion 4i that annularly protrudes from the first surface 4a so as to surround the protrusion 5, and the concave portion 4d is located inside the annular convex portion 4i. It may also be configured such that it is formed of.

(8) Furthermore, in the sample collection device 1 according to the above embodiment, the open port 7b is arranged on the second surface 4b of the plate-shaped portion 4, that is, on the surface 4a opposite to the collection port 7a. The structure is that However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the opening 7b may be arranged on the first surface 4a of the plate-shaped portion 4, that is, the opening 7b may be arranged on the same side of the surface 4a as the sampling port 7a. Further, for example, the opening 7b may be arranged on the side circumferential surface 4c of the plate-like portion 4.

(9) Moreover, the specimen collection device 1 according to the above embodiment is configured to include the columnar portion 3 connected to the side circumferential surface 4c of the plate-like portion 4. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the sample collection device 1 may be configured such that it does not include the columnar portion 3 and is formed entirely in a plate shape.

(10) Furthermore, in the specimen collecting device 1 according to the above embodiment, the columnar portion 3 is configured to protrude beyond the second surface 4b of the plate portion 4 in the thickness direction D3. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the columnar portion 3 may be configured to be smoothly continuous with the second surface 4b of the plate-like portion 4 without any step in the thickness direction D3. Furthermore, for example, the columnar portion 3 may be configured to be recessed relative to the second surface 4b of the plate-like portion 4 in the thickness direction D3.

(11) Furthermore, in the sample collecting device 1 according to the above embodiment, the inner space portion 7 is configured to include a step 7g between the storage portion 7d and the restraining portion 7f. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, as shown in FIG. 19, the inner space part 7 does not have a step 7g between the storage part 7d and the restraining part 7f, and the dimension W3 in the thickness direction D3 of the restraining part 7f is the same as that of the storage part 7d. It may be configured such that the dimension W4 in the thickness direction D3 of the distal end portion is gradually increased.

(12) Furthermore, the sample collection device 1 according to the above embodiment is configured such that the volume of the buffer section 7e is larger than the volume of the transfer section 7c. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the volume of the buffer section 7e may be less than or equal to the volume of the transfer section 7c.

(13) Furthermore, the sample collection device 1 according to the above embodiment is configured such that the volume of the buffer section 7e is 30% or more of the volume of the storage section 7d. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the volume of the buffer section 7e may be less than 30% of the volume of the storage section 7d.

(14) Furthermore, in the specimen collecting device 1 according to the above embodiment, the transmission part 4g is formed in a deformable membrane shape. However, the sample collection tool 1 is not limited to such a configuration. For example, the transparent portion 4g may have a rigidity that cannot be deformed.

(15) Furthermore, in the specimen collecting device 1 according to the above embodiment, the transmitting section 4g is configured to transmit a part of the specimen in the storage section 7d. However, the sample collection tool 1 is not limited to such a configuration. For example, the transmitting section 4g may be configured to transmit all of the sample in the storage section 7d.

(16) Furthermore, in the sample collecting device 1 according to the above embodiment, the hydrophilicity of the deterrent portion 7f is smaller than the hydrophilicity of at least a portion of the storage portion 7d. However, although the sample collection device 1 preferably has such a configuration, it is not limited to this configuration. For example, the hydrophilicity of the deterrent portion 7f may be the same as the hydrophilicity of the storage portion 7d. Furthermore, for example, the hydrophilicity of the deterrent portion 7f may be greater than the hydrophilicity of the storage portion 7d.

(17) Moreover, in the specimen collection device 1 according to the above embodiment, the transfer portion 7c is separated from the measurement region 7h when viewed in the thickness direction D3. However, the sample collection tool 1 is not limited to such a configuration. For example, as shown in FIGS. 20 and 21, it is preferable to have a configuration in which the transfer portion 7c is connected to the measurement region 7h when viewed in the thickness direction D3. That is, it is preferable to have a configuration in which the distance W2 (see FIG. 9) between the transfer section 7c and the measurement area 7h is zero. According to such a configuration, the amount of specimen required for measuring the specimen can be extremely reduced.

DESCRIPTION OF SYMBOLS 1... Specimen collection tool, 2... Main body part, 2a... Detected part, 3... Column-shaped part, 4... Plate-shaped part, 4a... First surface, 4b... Second surface, 4c... Side peripheral surface, 4d... Recessed part, 4e...First wall part, 4f...Second wall part, 4g...Transmissive part, 4h...Guide part, 4i...Annular convex part, 5...Protrusion part, 5a...Protrusion main body part, 5b...Convex part, 6...Detection circuit 6a... Conductive part, 6b... First terminal, 6c... Second terminal, 7... Inner space part, 7a... Collection port, 7b... Opening port, 7c... Transfer part, 7d... Storage part, 7e... Buffer part, 7f... Suppressing portion, 7g... Step, 7h... Measurement area, 11... Base member, 11a... Buffering recess, 11b... Guiding projection, 11c... Suppressing recess, 11d... Transfer opening, 12... Layer member, 12a... Storage opening, 12b... Suppression opening, 13... Membrane member, 100... Measuring system, 101... Measuring device, 102... Measuring device main body, 102a... Mounting port, 103... Measuring part, 103a... Contact part, 104... Position detection Part, 104a... Electrode, 105... Specimen specified amount detection part, 105a... Electrode, D1... Longitudinal direction, D2... Short direction, D3... Thickness direction, X1... Syringe, X2... Placement surface

Claims (7)

Equipped with a main body formed in a plate shape,
The main body portion includes an inner space portion into which a liquid specimen is transferred by capillary action,
The inner space section includes a collection port for collecting a sample, a storage section for storing the sample inside, and a deterrent connected to an end portion of the storage section to prevent the sample from being transferred from the storage section. and an opening for communicating the restraint part with the outside of the main body part,
In the thickness direction of the main body part, the size of the restraining part is larger than the size of the distal end part of the storage part,
The main body portion includes a plate-shaped portion formed in a plate shape, and a protrusion portion that protrudes from the first surface of the plate-shaped portion in the thickness direction and has the collection port at its tip,
The inner space portion includes a transfer portion extending from the collection port in the thickness direction inside the protrusion. The specimen collection device according to claim 1, wherein the inner space section includes a step between the storage section and the restraining section. The inner space portion includes a buffer portion that has the deterrent portion and the open opening and is capable of accommodating a specimen ;
The sample collection device according to claim 1 or 2, wherein the volume of the buffer section is larger than the volume of the transfer section. The inner space portion includes a buffer portion that has the deterrent portion and the open opening and is capable of accommodating a specimen;
The main body section includes a transmission section that allows at least a portion of the sample in the storage section to pass through,
The transparent part is formed in a deformable membrane shape,
The specimen collection device according to any one of claims 1 to 3, wherein the volume of the buffer section is 30% or more of the volume of the storage section. The specimen collection device according to any one of claims 1 to 4, wherein the hydrophilicity of the deterrent portion is smaller than the hydrophilicity of at least a portion of the storage portion. A method for manufacturing a sample collection device according to any one of claims 1 to 5, comprising:
a base member having a deterrent recess that constitutes the deterrent section; a layer member that has a reservoir opening that constitutes the reservoir; and a deterrent opening that constitutes the deterrent section; and the reservoir opening and the deterrent opening. preparing a membrane member that covers the
fixing the base member and the layer member so that the deterrence recess and the deterrence opening are connected;
A method for manufacturing a specimen collection device, comprising fixing the layer member and the membrane member so that the membrane member covers the storage opening and the suppression opening. The specimen collecting device according to any one of claims 1 to 5,
A measuring system comprising: a measuring device that measures a specimen collected with the specimen collecting tool.

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