JP2005185377A - Manufacturing method for body fluid sampling tool and body fluid sampling tool - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a manufacturing method for a body fluid sampling tool with which the loss of body fluid to be sampled is reduced or prevented and the body fluid sampling tool manufactured by the manufacturing method for the body fluid sampling tool. <P>SOLUTION: The manufacturing method for the body fluid sampling tool can be applied to manufacture of a detection unit 7 (body fluid sampling tool) provided with a blood transfer path (body fluid transfer path) 74 for sampling and transferring blood (body fluid). When the detection unit 7 is manufactured, a cover (first member) 72 defining the blood transfer path 74 and a base (second member) 71 are joined by ultrasonic fusion. The cover 72 is provided with a recessed part 724 for receiving the base 71. In joining them, projection parts 712a and 712b projected forward ( sideward ) are provided on the wall surface 71c on the distal end side of the base 71, they are melted to interrupt a groove-like gap 75. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a method for producing a body fluid collecting device and a body fluid collecting device.

  In recent years, with the increase in the number of diabetic patients, self blood glucose measurement in which patients themselves monitor fluctuations in daily blood glucose levels has been recommended.

  Here, when blood glucose is measured at home or the like, a small wound is made on the skin with a needle, a blade edge, or the like, and blood that has bleed from the wound is used.

  However, creating a wound on the skin is painful even though it is a minor wound. In the case of diabetic patients, this must be done several times a day, which is a heavy burden on the patient.

  Therefore, a chip (body fluid collecting tool) capable of measuring a blood sugar level with a smaller amount of blood has been developed (for example, see Patent Document 1).

  In this chip, blood is collected through a blood passage (body fluid transfer path), supplied to a test paper that develops color according to the amount of glucose in the blood, developed, and colored, and the degree of coloration is optically measured. Measure (colorimetric) automatically. Thereby, the blood sugar level (the amount of glucose in the blood) is quantified.

  The blood passage of such a chip is preferably a finely designed fine passage, and can be efficiently manufactured by ultrasonically welding two injection molded members.

  Here, when two members are joined, a gap is inevitably formed between the two members due to their tolerances and the like. Among these, when a gap communicating with the blood passage is formed, a part of the collected blood flows into the gap instead of the blood passage, and there is a problem that the loss of blood (body fluid) increases.

JP 2001-314394 A

  An object of the present invention is to provide a method for manufacturing a body fluid sampling device that can reduce or prevent the loss of body fluid to be collected, and a body fluid sampling device manufactured by the method for manufacturing the body fluid sampling device.

Such an object is achieved by the present inventions (1) to (10) below.
(1) A method for manufacturing a body fluid sampling device in which a body fluid sampling device is manufactured by joining, by ultrasonic fusion, a first member and a second member that define a body fluid transfer path for collecting and transferring body fluid. There,
The first member has a recess for receiving at least a portion of the second member;
Protruding portions projecting sideways are provided on at least one of the wall surface of the recess of the first member and the wall surface of the portion of the second member that fits in the recess,
When joining the first member and the second member, the protrusion is melted by ultrasonic waves, whereby the wall surface of the recess and the wall surface of the portion of the second member that fits in the recess A method for manufacturing a bodily fluid collecting tool, wherein a groove-like gap formed between the two is cut off.

  (2) In the state in which the first member and the second member are joined, the second member is configured so that almost all of the second member is accommodated in the recess of the first member. A method for producing a body fluid collecting tool according to 1).

  (3) The method for manufacturing a body fluid sampling device according to (1) or (2), wherein the two protrusions are provided apart from each other.

  (4) The two projecting portions of the bodily fluid collecting tool according to (3), wherein the two projecting portions are provided in the vicinity of a portion serving as a bodily fluid inlet into which the bodily fluid flows in the bodily fluid transfer path. Production method.

  (5) The projecting portion according to any one of (1) to (4), wherein the protrusion is provided on any one of a wall surface of the recess and a wall surface of a portion of the second member that fits in the recess. A method for producing a body fluid collecting device.

  (6) A bodily fluid collecting tool manufactured by the method for producing a bodily fluid collecting tool according to any one of (1) to (5) above.

(7) A bodily fluid collecting tool formed by joining a first member and a second member that define a bodily fluid transfer path for collecting and transferring bodily fluid by ultrasonic fusion,
The first member has a recess for receiving the second member;
A groove-like gap formed between the wall surface of the recess of the first member and the wall surface of the second member is blocked in the vicinity of the body fluid inlet into which the body fluid flows in the body fluid transfer path. A body fluid collecting device characterized by the above.

  (8) The body fluid sampling device according to (7), wherein the gap is blocked by ultrasonic fusion between the first member and the second member.

  (9) The bodily fluid collecting tool according to any one of (6) to (8), wherein a volume of the bodily fluid transfer path is 0.05 to 10 μL.

(10) The bodily fluid collecting tool according to any one of (6) to (9), wherein a cross-sectional area of the bodily fluid transfer path is 0.05 to 10 mm ² .

  According to the body fluid collecting device of the present invention, it is possible to reduce or prevent the loss of body fluid to be collected.

  Moreover, according to the method for producing a body fluid collecting device of the present invention, such a body fluid collecting device can be produced in a short time and at low cost.

  Hereinafter, the manufacturing method of the bodily fluid collecting tool and the preferred embodiment of the bodily fluid collecting tool of the present invention will be described in detail.

  1 is a perspective view showing an embodiment of a chip to which the body fluid sampling device of the present invention is applied, FIG. 2 is a cross-sectional view taken along line AA in FIG. 1, and FIG. 3 is a cross-sectional view taken along line BB in FIG. FIG. 4 is a bottom view of the detection unit included in the chip shown in FIG.

  In the following, in FIGS. 1 to 4, the left side is “tip” and the right side is “base end”, and in FIGS. 1 and 3, the upper side is “up” or “upper”, and the lower side is “lower” or As “down”, the back side of the page in FIG. 2 is “down” or “down”, the front side of the page is “up” or “upper”, and the front side of the page in FIG. 4 is “down” or “down”. The description will be made assuming that the back side of the page is “up” or “up”. In FIG. 1, the test paper is omitted.

  The chip 1 shown in each figure has a puncture means and is loaded into a component measuring device (blood component measuring device) capable of measuring (detecting) a predetermined component in a body fluid collected through the surface of the living body (skin). (Attached) and used.

  The part (body fluid collection part) involved in the collection of body fluid on the surface of the living body (skin) is preferably a finger, but in addition, for example, the hand (palm, back of hand, side of hand), arm, thigh, earlobe, etc. It may be.

  Hereinafter, blood will be described as a representative body fluid, glucose as a predetermined component, and a fingertip (finger) as a body fluid collection site.

  The chip 1 includes a casing 3, a puncture needle 5, and a detection unit (a body fluid collecting tool of the present invention) 7. Hereinafter, each component will be sequentially described.

  The puncture needle 5 includes a needle body 51 and a hub 52 fixed (fixed) to the proximal end portion of the needle body 51. The hub 52 is fixed to the needle body 51 by, for example, fitting, adhesive bonding, fusion, caulking, or the like, or integrally formed by insert molding or the like.

  The needle body 51 is made of, for example, a metal such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy, and has a sharp needle tip (blade tip) 511 at the tip thereof. The needle tip 511 punctures the surface (skin) of the fingertip, which is the surface of the living body, and causes blood (body fluid) to come out (bleed) from the puncture site.

  In addition, as a constituent material of the needle body 51, for example, a ceramic material can be used.

  The needle body 51 may be a hollow needle, but is more preferably a solid needle. Thereby, it can be set as the needle body 51 of a smaller diameter. As a result, the patient's pain can be further reduced when the skin is punctured.

  The needle body 51 is provided with a hub 52 so that the needle tip 511 protrudes. In other words, the hub 52 is provided so as to cover the outer periphery of the needle body 51 on the proximal end side from the needle tip 511.

  The hub 52 includes a cylindrical portion 53 having a substantially cylindrical shape on the distal end side, and a rectangular parallelepiped portion 54 having a substantially rectangular parallelepiped shape on the proximal end side. The outer diameter (diameter) of the cylindrical portion 53 and the height of the rectangular parallelepiped portion 54 are set to be substantially equal.

  A fitting portion 531 having a diameter larger than the outer diameter of the columnar portion 53 is formed at the tip of the columnar portion 53. The fitting portion 531 is fitted to a fitting portion 35 of the casing 3 described later.

  A pair of protrusions 541 are formed at the tip of the rectangular parallelepiped portion 54 so as to protrude laterally. Each protrusion 541 comes into contact with a step 34 of the casing 3 described later.

  In addition, a connecting portion 542 having a shape corresponding to the shape of the distal end portion (holder portion) of the puncturing means included in the component measuring device is formed at the proximal end portion of the rectangular parallelepiped portion 54. In a state where the chip 1 is loaded in the component measuring device (hereinafter referred to as “chip loaded state”), the connecting portion 542 is fitted (inserted) into the holder portion, whereby the puncture needle 5 is connected to the puncturing means. The

  Such a puncture needle 5 is movably provided (stored) in a lumen 33 of the casing 3. The casing 3 is configured by a substantially rectangular parallelepiped member, and a distal end opening (opening) 31 and a proximal end opening 32 where the lumen portion 33 is opened are formed at the distal end and the proximal end, respectively. The needle body 51 (at least the needle tip 511) provided in the puncture needle 5 passes through the tip opening 31 and protrudes from the tip of the casing 3 (chip 1).

  As shown in FIG. 2, the lumen portion 33 includes a first lumen portion 331 on the distal end side and a second lumen portion 332 on the proximal end side.

  The first lumen portion 331 has a substantially cylindrical shape, and is set so that its cross-sectional area is substantially equal to or slightly larger than the cross-sectional area (maximum) of the fitting portion 531 of the hub 52. Further, the second lumen 332 has a substantially rectangular parallelepiped shape, and the cross-sectional area thereof is set to be substantially equal to or slightly larger than the cross-sectional area (maximum) of the rectangular parallelepiped portion 54 (protrusion 541). ing.

  When the puncture needle 5 moves relative to the casing 3, the fitting portion 531 of the hub 52 moves along the inner surface of the first lumen portion 331, and the portion of the projection 541 of the hub 52 is the second inner portion. It moves along the inner surface of the cavity 332.

  Thus, when the puncture needle 5 moves relative to the casing 3, the puncture needle 5 is supported at two locations of the fitting portion 531 and the protrusion 541 of the hub 52, so that it can move smoothly relative to the casing 3. In addition, it is possible to prevent the casing 3 from being shaken and to move in the distal direction with high straightness. Thereby, the increase in the patient's pain accompanying the blurring of the needle tip 511 of the needle body 51 can be suitably prevented.

  In the casing 3, a step 34 is formed at the boundary between the first lumen 331 and the second lumen 332. For this reason, when the puncture needle 5 moves in the distal direction, the protrusion 541 of the hub 52 contacts the stepped portion 34. Thereby, the movement of the puncture needle 5 is stopped, and the protruding length of the needle tip 511 of the puncture needle 5 from the casing 3 is regulated. Thereby, it is possible to prevent the finger (body fluid collection site) from being punctured more than necessary.

  In addition, a fitting portion 35 having a reduced diameter with respect to the inner diameter of the first lumen portion 331 is formed at the proximal end portion of the first lumen portion 331. The fitting portion 531 of the puncture needle 5 is fitted to the fitting portion 35. Thereby, the puncture needle 5 is fixed to the casing 3.

  In the chip 1 of this embodiment, the puncture needle 5 is fixed to the casing 3 before and after use. For example, in the chip 1 after use, if the puncture needle 5 is fixed to the casing 3, the puncture needle 5 after use may accidentally damage the skin or the like, or blood may scatter and surround the surroundings. Contamination can be prevented and safety is high.

  In addition, a pair of flanges 39 project from the front end of the casing 3 on both side surfaces thereof. Each flange 39 abuts on the component measuring device in a state where the chip is loaded. Further, when the chip 1 is removed from the component measuring device, if an eject mechanism provided in the component measuring device is operated, the eject pin provided therein moves in the distal direction, and the distal end presses the flange 39 in the distal direction. Thereby, the chip | tip 1 is removed from a component measuring apparatus.

  In addition, a pair of opposing wall portions 40, a wall portion 41, and a protrusion 42 are formed on the upper surface of the casing 3. The wall portion 40 is erected along both side portions on the front end side of the casing 3, and the wall portion 41 is erected in the middle of the casing 3 in the longitudinal direction so as to be substantially orthogonal to the longitudinal direction. A detection unit 7 described later is attached to a portion surrounded by these wall portions 40 and 41.

  Inside the wall portion 40, a pair of protrusions 42 are erected in contact with the wall portion 40. Each protrusion 42 is inserted into a recess 723 formed in the cover 72 of the detection unit 7. Thereby, the detection unit 7 is positioned and fixed with respect to the chip 1. In this state, the tip position of the detection unit 7 and the tip position of the casing 3 are substantially coincident.

  The detection unit 7 collects blood and detects glucose (predetermined component) in the blood. The detection unit 7 includes a base (second member) 71, a cover (first member) 72 joined to the base 71, and a test paper 73 provided on the cover 72.

The base 71 is composed of a flat plate member.
The cover 72 is composed of a substantially rectangular parallelepiped member. A recess 724 is formed in the lower surface of the cover 72 along the longitudinal direction thereof. The base 71 is fixed (fixed) in the recess 724.

  A groove 725 that opens to the lower surface (bottom surface) of the concave portion 724 is formed at a substantially central portion in the lateral direction (width direction). The groove 725 is formed substantially in a straight line and along the longitudinal direction of the cover 72. The groove 725 is open at the tip of the cover 72.

  Further, a recess (notch) 726 communicating with the groove 725 is formed at the tip of the cover 72. The recess 726 is formed along the thickness direction of the cover 72, and constitutes a blood collection unit (body fluid collection unit) that functions to collect blood that has come out on the surface of the finger and guide it to the blood transfer path 74 described later. To do.

  It is preferable that the inner surface of the recess 726, the inner surface of the groove 725, and the portion corresponding to the groove 725 on the upper surface of the base 71 (the inner surface of a bodily fluid transfer path 74 described later) are subjected to a hydrophilic treatment. Thereby, blood can be collected more reliably and transferred smoothly by the test paper 73.

  On the upper surface of the cover 72, a test paper setting portion 721 for forming a test paper 73 at the base end portion is formed. The test paper setting portion 721 is formed of a concave portion having a substantially circular shape (planar shape corresponding to the test paper 73) in plan view, and a through hole 722 communicating with the groove 725 is formed at the center of the bottom surface. Has been.

  The groove 725 is closed by the base 71 in a state where the base 71 is fixed (joined) in the recess 724 of the cover 72. Thus, the groove 725 and the through hole 722 define a blood transfer path (body fluid transfer path) 74 for collecting and transferring blood (body fluid).

  The blood transfer path 74 has a blood inlet 741 that opens to the tip of the detection unit 7 and a blood outlet 742 that opens to the upper part (above) of the detection unit 7.

  The blood that has contacted the blood inlet (contact part) 741 of the blood transfer path 74 is transferred through the blood transfer path 74 by capillary action, and the test paper 73 installed in the test paper installation part 721 via the blood outlet 742. Supplied in the center of

  The base 71 is formed with a convex portion 743 that protrudes into the blood transfer path 74. The convex portion 743 is provided in the vicinity of the blood outlet 742. Thereby, the cross-sectional area of the blood transfer path 74 on the blood outlet 742 side can be reduced with respect to the blood inlet 741 side, and blood transfer by capillary action in the blood transfer path 74 can be further promoted.

  Further, in a state where the cover 72 and the base 71 are joined (fixed) so that the base 71 is accommodated in the recess 724 of the cover 72, a gap other than the blood transfer path 74 is inevitably formed due to their tolerances and the like. The

  Among these, two blocking portions (blocking portions) 76 a and 76 b are provided so as to block a part of the gap 75 communicating with the blood transfer path 74. In this embodiment, the blocking portions 76 a and 76 b are provided in the vicinity of the blood inlet 741 with a blood transfer path 74 (blood inlet 741) therebetween, and between the wall surface 72 c of the recess 724 and the wall surface 71 c of the base 71. The groove-like gap 75 formed in the upper portion is blocked (see FIG. 4). As a result, it is possible to reliably reduce or prevent blood from wrapping around (diffusing) into unnecessary portions (gap 75) other than blood transfer path 74, that is, blood loss. As a result, the chip 1 can reliably measure the blood glucose level with a smaller amount of blood.

  In addition, since the blood sugar level can be measured with a smaller amount of blood in this way, a needle having a smaller diameter can be used as the needle body 51 of the puncture needle 5, and as a result, the patient's pain can be reduced. Can be reduced.

  In the present embodiment, in a state where the cover 72 and the base 71 are joined, almost all of the base 71 is configured to fit within the recess 724 of the cover 72. By adopting such a configuration, the detection unit 7 can be reduced in size (in particular, thinner).

  Further, in this configuration, when the blocking portion is not provided, the gap 75 communicating with the blood transfer path 74 is opened directly on the lower surface of the detection unit 7, so that the blood that has flowed into the gap 75 scatters around. It becomes easy. On the other hand, by providing the blocking portions 76a and 76b, it is possible to reduce or prevent the outflow of blood to the gap 75 and to prevent blood from scattering to the periphery. The present invention is suitable for application to the detection unit 7 having such a configuration, that is, the body fluid collecting tool having a configuration in which almost all the part of the other member is received in the recess of the one member.

  Further, the volume of the blood transfer path 74 is preferably about 0.05 to 10 μL, and more preferably about 0.05 to 5 μL.

The cross-sectional area of the blood transfer path 74 (cross-sectional area in a direction substantially perpendicular to the blood transfer direction) is preferably about 0.05 to 10 mm ² , and is preferably about 0.1 to ⁵ mm ^2. More preferred.

  As described above, in the detection unit 7 having the body fluid transfer path 74 with a small capacity, even a small amount of blood loss greatly affects the measurement accuracy of the blood glucose level. Therefore, it is particularly effective to apply the present invention to such a detection unit 7 to reduce or prevent blood loss.

  The test paper 73 can detect glucose in blood, and is formed, for example, by carrying (impregnating) a reagent (coloring reagent) on a carrier (absorber) capable of absorbing blood. This carrier is preferably composed of a porous membrane. In this case, the porous membrane preferably has a pore size that can filter out red blood cells in blood.

  Examples of the reagent impregnating the carrier (porous membrane) include glucose oxidase (GOD), peroxidase (POD), and 4-aminoantipyrine, N-ethyl N- (2-hydroxy-3) in the case of blood glucose measurement. -Sulfopropyl) -m-Toluidine and other color former (coloring reagent), etc., depending on the measurement component, for example, ascorbate oxidase, alcohol oxidase, alcohol dehydrogenase, galactose oxidase, fructose dehydrogenase, cholesterol oxidase, Examples thereof include those that react with blood components (predetermined components) such as cholesterol dehydrogenase, lactate oxidase, lactate dehydrogenase, bilirubin oxidase, and xanthine oxidase, and color formers (coloring reagents) similar to those described above.Further, a buffering agent such as a phosphate buffer may be included. Needless to say, the types and components of the reagents are not limited to these.

  In addition, as means for detecting glucose, instead of the test paper 73, one using an electrode can be adopted.

  Such a chip 1 has a lid 8 attached to the tip thereof so as to close the inner cavity 33 of the casing 3. The lid 8 is attached to the chip 1 before use (unused chip 1), and is removed when the chip 1 is used.

  As the constituent materials of the casing 3, the hub 52, the base 71, the cover 72, and the lid body 8 described above, for example, ABS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, respectively. And thermoplastic polyurethane, polymethyl methacrylate, polyoxyethylene, fluororesin, polycarbonate, acetal resin, acrylic resin, polyethylene terephthalate, and the like.

  Next, a method for manufacturing the detection unit (the body fluid sampling device of the present invention) 7 will be described with reference to FIGS.

  5A is a bottom view, FIG. 5B is a cross-sectional view taken along line XX in FIG. 5A, and FIG. 6 is a diagram illustrating the structure of the base. FIG. 7A is a top view, FIG. 7B is a cross-sectional view taken along line YY in FIG. 7A, and FIG.

  In the following, in FIGS. 5 to 7, the left side is “tip” and the right side is “base end”, and in FIG. 5A, the back side of the page is “up” or “upward”, and the front side of the page is “ As “down” or “down”, the upper side is “up” or “upward” in FIG. 5B, the lower side is “down” or “down”, and the front side of FIG. 6A is “up”. ”Or“ upper ”, the back side of the page as“ lower ”or“ lower ”, the lower side as“ upper ”or“ upper ”, and the upper side as“ lower ”or“ lower ”in FIGS. ,explain.

  As shown in FIG. 5, on the lower surface 724 b in the recess 724 of the cover 72, a protrusion 727 that protrudes in a U shape around the groove 725 is formed integrally with the cover 72.

Further, a tapered surface 728 is formed on the edge portion on the front end side of the concave portion 724 of the cover 72.
On the other hand, as shown in FIG. 6, a U-shaped groove 711 is formed on the upper surface 71 a of the base 71 so as to correspond to the ridges 727 of the cover 72.

  In addition, two protrusions 712 a and 712 b that protrude toward the cover 72 in a state where the cover 72 and the base 71 are overlapped are formed integrally with the base 71 on the wall surface 71 c on the distal end side of the base 71. ing. In the present embodiment, the protrusions 712a and 712b are provided so as to protrude laterally (forward).

  Each of the protrusions 712a and 712b is provided in the vicinity of the portion that becomes the blood inlet 741 of the blood transfer path 74 with the portion separated (separated). Each of the protrusions 712a and 712b has a shape (tapered shape) in which the thickness gradually decreases toward the outside.

  When joining the base 71 and the cover 72, first, as shown in FIG. 7A, the concave portion 724 of the cover 72 is disposed so that the convex portion 727 of the base 71 faces downward. Then, they are overlapped (positioned) so that the base 71 is positioned in the recess 724.

  Accordingly, the vicinity of the top of the ridge 727 is inserted into the groove 711 and comes into contact with the bottom surface of the groove 711. Further, the tip surfaces (tapered surfaces) of the protrusions 712 a and 712 b abut on the tapered surface 728 of the cover 72.

  Next, the flat pressing surface of the pressing member is brought into contact with the lower surface 71b of the base 71, the base 71 is pressed toward the cover 72, and in this state, ultrasonic waves are applied to the base 71 and the cover 72.

  This mainly melts the vicinity of the inner surface of the groove 711, the protrusions 712 a and 712 b, the protrusions 727, and the leading edge of the recess 724, and the base 71 is moved toward the cover 72 by the pressing force of the pressing member. Move closer.

  At this time, by forming the protrusions 712 a and 712 b in a tapered shape, the base 71 can be smoothly accommodated in the recess 724 of the cover 72, that is, the cover 72 and the base 71 can be joined. Can be performed smoothly.

  Then, when the positions in the thickness direction of the lower surface 71b of the base 71 and the lower surface 72b of the cover 72 substantially coincide with each other, the application of ultrasonic waves is finished.

  As a result, the melted portion is cured, the base 71 and the cover 72 are joined (integrated), and a blood transfer path 74 is formed as shown in FIG. 7B.

  At this time, the groove-like gap 75 formed between the cover 72 and the base 71 is blocked (blocked) by the blocking portions 76a and 76b formed by melting and curing the protrusions 712a and 712b. The Thereby, at the time of blood collection, it is possible to prevent blood from flowing into the gap 75 (unnecessary portion other than the blood transfer path 74), thereby reducing or preventing blood loss.

  In particular, since the closed portions 76a and 76b are formed in the vicinity of the blood inlet 741, blood loss can be more reliably reduced or prevented.

  The gap 75 may be configured to be closed at three or more locations, or may be configured to close almost all of the gaps 75. However, by adopting a configuration in which the gap 75 is closed at two locations, the concave portion 724 of the cover 72 is provided. It is possible to prevent the base 71 from becoming difficult to enter, and the cover 72 and the base 71 can be more easily and reliably joined.

  Further, in the present embodiment, the protrusion for forming the blocking portion that closes the gap communicating with the blood transfer path 74 is described as being provided on the base 71, but the protrusion is provided on the cover 72. Alternatively, both the base 71 and the cover 72 may be provided.

  Thus, in the present invention, the cover 72 and the base 71 are joined (integrated) by fusion bonding, so that no adhesive is required, and the drying time of the adhesive is omitted. Moreover, since the fusion time is short, work efficiency is greatly improved.

  In addition, according to ultrasonic fusion, only the joint portion is appropriately melted (dissolved) by ultrasonic vibration to be fused and integrated. The shape change is small. Thereby, it is possible to prevent the cover 72 and the base 71 from being deformed due to shrinkage accompanying heating and cooling after joining. Further, according to the ultrasonic fusion, there is an advantage that the cover 72 and the base 71 can be bonded with high bonding strength.

The conditions for performing ultrasonic fusion can be set as follows, for example.
That is, the frequency of the ultrasonic wave is preferably about 20 to 40 kHz, more preferably about 25 to 35 kHz.

  The pressing force by the pressing member is preferably about 0.2 to 0.25 MPa, more preferably about 0.22 to 0.24 MPa.

  The fusion time is preferably about 0.05 to 0.3 seconds, more preferably about 0.07 to 0.2 seconds.

  The holding time (time for applying only the pressing force) is preferably 2 seconds or less, more preferably about 0.5 to 1 second.

  Further, as in the present embodiment, the protrusions 712a and 712b are formed integrally with the base 71, so that the joining of the cover 72 and the base 71 and the formation of the blocking portions 76a and 76b are substantially the same. It can be done in a batch depending on conditions. Thereby, the manufacturing time of the detection unit 7 can be shortened.

  Furthermore, the constituent materials of the cover 72 and the base 71 are preferably the same. Accordingly, the constituent material of the cover 72 and the base 71 has the same melting point and good compatibility, so that the resin melted from the cover 72 and the resin melted from the base 71 are integrated with each other. The ultrasonic vibration can be applied most efficiently and reliable fusion without burrs can be performed.

  In this embodiment, the chip 1 is manufactured by closing the groove 75 when the cover 72 and the base 71 are joined. After joining the base 71, the gap 75 may be closed and manufactured.

  As mentioned above, although the manufacturing method and bodily fluid collection tool of the bodily fluid collection tool of this invention were demonstrated based on each embodiment of illustration, this invention is not limited to this.

  For example, the configuration of each part of the body fluid sampling device of the present invention can be replaced with any configuration that can exhibit the same function.

  Further, for example, in the bodily fluid collecting device of the present invention, the puncture needle and the casing may be omitted in the above embodiment, and the function of detecting the amount of a predetermined component in the blood is further omitted. It may be.

  In the above embodiment, blood is representatively described as the body fluid to be collected. However, in the present invention, the body fluid to be collected is not limited to this, for example, sweat, lymph fluid, interstitial fluid, spinal fluid, and the like. Also good.

  Moreover, in the said embodiment, glucose was represented as a representative component (predetermined component) for measurement, but the component for measurement is not limited to this, for example, protein, cholesterol, uric acid, creatinine, alcohol, etc. Organic compounds, inorganic ions such as sodium, potassium, calcium, chlorine, phosphoric acid, carbonic acid, pH, etc. may be used.

It is a perspective view which shows embodiment of the chip | tip to which the bodily fluid collection tool of this invention is applied. It is the sectional view on the AA line in FIG. It is the BB sectional view taken on the line in FIG. It is a bottom view of the detection unit with which the chip | tip shown in FIG. 1 is provided. It is a figure which shows the structure of a cover. It is a figure which shows the structure of a base. It is a figure (longitudinal section) showing the state where a cover and a base are joined.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Tip 3 Casing 31 Front end opening 32 Base end opening 33 Lumen part 331 1st lumen part 332 2nd lumen part 34 Step part 35 Fitting part 39 Flange 40, 41 Wall part 42 Projection 5 Puncture needle 51 Needle body 511 Needle tip 52 Hub 53 Cylindrical part 531 Fitting part 54 Rectangular body part 541 Projection part 542 Connection part 7 Detection unit 71 Base 71a Upper surface 71b Lower surface 71c Wall surface 711 Groove 712a, 712b Projection 72 Cover 72a Upper surface 72b Lower surface 72c Wall surface 72c Paper installation part 722 Through hole 723 Concave part 724 Concave part 724b Bottom surface 725 Groove 726 Concave part 727 Convex line 728 Tapered surface 73 Test paper 74 Blood transfer path 741 Blood inflow port 742 Blood outflow port 743 Convex part 75 Gap 76a, 76b Closure part 8 Lid

Claims (10)

A method for manufacturing a body fluid sampling device for manufacturing a body fluid sampling device by joining, by ultrasonic fusion, a first member and a second member that define a body fluid transfer path for collecting and transferring body fluid,
The first member has a recess for receiving at least a portion of the second member;
Protruding portions projecting sideways are provided on at least one of the wall surface of the recess of the first member and the wall surface of the portion of the second member that fits in the recess,
When joining the first member and the second member, the protrusion is melted by ultrasonic waves, whereby the wall surface of the recess and the wall surface of the portion of the second member that fits in the recess A method for manufacturing a bodily fluid collecting tool, wherein a groove-like gap formed between the two is cut off.   The said 2nd member is the state which joined the said 1st member and the said 2nd member, It is comprised so that substantially all may be settled in the said recessed part of the said 1st member. Manufacturing method for bodily fluid collection device.   The method for manufacturing a body fluid sampling device according to claim 1 or 2, wherein the two protrusions are provided apart from each other.   The method of manufacturing a bodily fluid collecting tool according to claim 3, wherein the two protrusions are provided in the vicinity of a portion of the bodily fluid transfer path that becomes a bodily fluid inflow port through which the bodily fluid flows.   5. The method for manufacturing a body fluid sampling device according to claim 1, wherein the protrusion is provided on any one of a wall surface of the recess and a wall surface of a portion of the second member that fits in the recess. .   A body fluid collecting device manufactured by the method for manufacturing a body fluid collecting device according to claim 1. A bodily fluid collecting tool formed by joining a first member and a second member that define a bodily fluid transfer path for collecting and transferring bodily fluid by ultrasonic fusion,
The first member has a recess for receiving the second member;
A groove-like gap formed between the wall surface of the recess and the wall surface of the second member of the first member is blocked in the vicinity of the body fluid inlet into which the body fluid flows in the body fluid transfer path. A body fluid collecting tool characterized by the above.   The bodily fluid collecting tool according to claim 7, wherein the gap is blocked by ultrasonic fusion between the first member and the second member.   The body fluid collecting device according to any one of claims 6 to 8, wherein a volume of the body fluid transfer path is 0.05 to 10 µL. Cross-sectional area of the fluid transfer channel is body fluid sampling tool according to any one of claims 6 to 9 is 0.05 to 10 mm ^2.

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