WO2010098339A1 - Système de mesure de composant in vivo, dispositif de collecte de fluide tissulaire et procédé de mesure de composant in vivo - Google Patents

Système de mesure de composant in vivo, dispositif de collecte de fluide tissulaire et procédé de mesure de composant in vivo Download PDF

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Publication number
WO2010098339A1
WO2010098339A1 PCT/JP2010/052826 JP2010052826W WO2010098339A1 WO 2010098339 A1 WO2010098339 A1 WO 2010098339A1 JP 2010052826 W JP2010052826 W JP 2010052826W WO 2010098339 A1 WO2010098339 A1 WO 2010098339A1
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WO
WIPO (PCT)
Prior art keywords
tissue fluid
skin
collection
contact
collecting
Prior art date
Application number
PCT/JP2010/052826
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English (en)
Japanese (ja)
Inventor
義裕 朝倉
利幸 佐藤
淳 樽谷
Original Assignee
シスメックス株式会社
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Publication date
Application filed by シスメックス株式会社 filed Critical シスメックス株式会社
Priority to JP2010538242A priority Critical patent/JP4643768B2/ja
Publication of WO2010098339A1 publication Critical patent/WO2010098339A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150977—Arrays of piercing elements for simultaneous piercing
    • A61B5/150984—Microneedles or microblades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood

Definitions

  • the present invention relates to an in-vivo component measurement system, a tissue fluid collection device, and an in-vivo component measurement method, and more particularly, to an in-vivo component measurement system, a tissue fluid collection device, and a living body using the tissue fluid collection device provided with a collection member that collects tissue fluid.
  • the present invention relates to a method for measuring internal components.
  • an in-vivo component measurement system including a collecting member for collecting tissue fluid is known (for example, see Patent Documents 1 and 2).
  • a skin permeation promoting process for facilitating extraction of tissue fluid is performed on a subject's skin to form a tissue fluid extraction site, and a collection member for collecting the tissue fluid is attached to the tissue fluid extraction site.
  • the tissue fluid is collected in the collecting member.
  • the in-vivo component is measured using the tissue fluid collected by the collection member.
  • a micropath tissue fluid extraction site
  • a gel collecting member
  • a micropore is formed in a test subject's skin using a micropore formation apparatus, and an extraction cartridge (collection member) is made to adhere to the micropore formation area
  • region tissue fluid extraction site
  • a belt part for wrapping around an arm of a subject, a main body part for holding an extraction cartridge, a receiving part provided with an opening, and a main body part with respect to the receiving part There is disclosed a blood sugar level analysis device including a hinge portion that rotatably supports the blood glucose level.
  • a micropore forming region is formed by a micropore forming device in the skin exposed in the opening through the opening of the receiving portion.
  • an extraction cartridge is set on the skin side surface of the main body part, and the main body part is rotated toward the opening part side of the receiving part, so that the extraction cartridge is formed with fine holes formed in the skin exposed in the opening part. It is comprised so that it may adhere to a formation area.
  • Patent Document 1 does not disclose how to attach the gel to the region where the micropath is formed. Since the micropath cannot be visually confirmed, it is considered that the subject has difficulty in accurately attaching the gel to the micropath. For this reason, if the test subject has attached the gel to a position deviated from the micropath, the tissue fluid cannot be collected normally, and the reliability of the measurement result of the in vivo component will be reduced. There is a problem.
  • Patent Document 2 the extraction cartridge is attached to the micropore formation area by rotating the main body through the hinge portion, so that the subject cannot visually confirm the micropore formation area.
  • Patent Document 2 not only the extraction cartridge necessary for collecting the tissue fluid but also the belt portion, the main body portion, the receiving portion, and the hinge portion that are not used during the collection of the tissue fluid while the tissue fluid is collected by the extraction cartridge. It is necessary to always wear a blood glucose analyzer including
  • the present invention has been made in order to solve the above-described problems, and one object of the present invention is to improve the reliability of the measurement result of the in-vivo component and to improve the reliability of the subject when collecting the tissue fluid.
  • An object of the present invention is to provide an in-vivo component measurement system, a tissue fluid collection device, and an in-vivo component measurement method capable of suppressing an increase in burden.
  • the in-vivo component measurement system includes an abutting member that abuts against the skin of a living body, and a tissue fluid of a living body with the abutting member abutting on the skin in advance and using the abutting member as a position reference.
  • Skin permeation enhancement processing for facilitating extraction of a predetermined portion of the skin, a skin permeation enhancement processing device that forms a tissue fluid extraction site, a collection member that collects tissue fluid, and holding the collection member, Using a contact member in contact with the skin as a position reference, a collection member holding member configured to allow the collection member to adhere to the tissue fluid extraction site and a component contained in the tissue fluid collected by the collection member are measured. And at least one of the contact member and the collection member holding member is configured to be able to be separated from the skin with the collection member attached to the tissue fluid extraction site.
  • tissue fluid extraction is performed by performing skin permeation enhancement processing using the contact member as a position reference in a state where the contact member is in contact with the skin in advance.
  • a collection member holding member configured to allow the collection member to adhere to the tissue fluid extraction site using the contact member in contact with the skin as a position reference.
  • At least one of the abutting member and the collecting member holding member is configured to be able to be separated from the skin in a state where the collecting member is attached to the tissue fluid extraction site.
  • a tissue fluid collection device forms a tissue fluid extraction site by performing a skin permeation enhancement process that facilitates extraction of tissue fluid to a predetermined site of the skin in a state of being in contact with the skin of a living body in advance.
  • a contact portion that functions as a position reference of the skin permeation enhancement processing apparatus, a collection member that collects tissue fluid, and a collection member that holds the collection member and uses the contact portion that is in contact with the skin as a position reference.
  • a collecting member holding portion configured to be able to adhere to the extraction site, and at least one of the contact portion and the collecting member holding portion is attached to the tissue fluid extraction site from the skin. It is configured to be able to be separated.
  • the position reference of the skin permeation enhancement processing device that forms the tissue fluid extraction site by performing the skin permeation enhancement processing in a state of being in contact with the skin of the living body in advance.
  • a collection member holding portion configured to be able to attach the collection member to the tissue fluid extraction site with the contact portion in contact with the skin as a position reference.
  • At least one of the contact portion and the collection member holding portion is configured to be able to be separated from the skin in a state where the collection member is attached to the tissue fluid extraction site, thereby making the collection member a tissue fluid extraction site.
  • both the contact portion and the collection member holding portion are configured to be able to be separated from the skin in a state where the collection member is attached to the tissue fluid extraction site. Yes.
  • both the contact portion and the collection member holding portion that are not used during the collection of the tissue fluid are removed from the skin, and only the collection member is attached to the skin. It can be left attached. This can minimize the number and weight of members attached to the subject's skin when collecting the tissue fluid, thereby further reducing the burden on the subject when collecting the tissue fluid.
  • the contact portion and the skin permeation enhancement processing device are a first positioning portion and a second positioning portion for positioning the skin permeation enhancement processing device with respect to the contact portion, respectively.
  • the skin permeation enhancement processing apparatus has a positioning part and performs skin permeation enhancement processing using the contact part as a position reference while being positioned with respect to the contact part by the first positioning part and the second positioning part.
  • the tissue fluid extraction site is formed. If comprised in this way, since a test subject can position a skin permeation enhancement processing apparatus in a predetermined position with respect to a contact part by a 1st positioning part and a 2nd positioning part, it is reliably with respect to a contact part.
  • the tissue fluid extraction site can be formed at the same position.
  • the collection member holding unit is configured to be able to be separated from the skin in a state where the collection member is attached to the tissue fluid extraction site.
  • the collecting member is adhered to the tissue fluid extraction site, and the collection member holding unit is When separated from the skin, the collecting member holding part and the collecting member are configured to be unbonded.
  • the collecting member can be left adhered and adhered to the tissue fluid extraction site only by a simple operation of pressing the collecting member holding portion against the skin and then separating it. Thereby, the test subject's burden at the time of collecting tissue fluid can further be reduced.
  • the collecting member collects and holds the tissue fluid, holds the collecting body, and is bonded to the skin, and the second bonding is bonded to the collecting member holding portion.
  • the adhesive strength of the first adhesive portion to the skin is greater than the adhesive strength of the second adhesive portion to the collection member holding portion.
  • the adhesion area between the first adhesive part of the collector holding part and the skin is the second adhesive of the collector holder. It is larger than the bonding area between the part and the collecting member holding part. If comprised in this way, the adhesive force with respect to the skin of a 1st adhesion part can be easily made larger than the adhesion force with respect to the collection member holding part of a 2nd adhesion part.
  • the collecting body holding portion is preferably formed in a film shape. If comprised in this way, since the collection body holding
  • the collecting body holding section preferably has moisture impermeability. If comprised in this way, since it can suppress that a water
  • the collecting body is preferably made of a gel member. If comprised in this way, a tissue fluid can be easily collected using a gel member.
  • the collection member holding portion and the contact portion are integrally formed. If comprised in this way, it can suppress that a number of parts increases. In addition, since it is possible to suppress an increase in the number of parts handled by the subject, the user can easily collect the tissue fluid.
  • the apparatus further includes a hinge portion formed integrally with the collection member holding portion and the contact portion, and the collection member holding portion has a first position where the hinge portion is folded with respect to the contact portion.
  • the tissue fluid extraction is performed by performing skin permeation enhancement processing by the skin permeation enhancement processing device in a state where the hinge portion is displaceable to the opened second position and the collecting member holding portion is located at the second position.
  • the collecting member held by the collecting member holding portion is configured to adhere to the tissue fluid extraction portion in a state where the portion is formed and the collecting member holding portion is located at the first position.
  • a test subject will form a tissue fluid extraction site
  • the subject can collect tissue fluid by attaching the collection member to the tissue fluid extraction site accurately by a simple operation.
  • the contact portion includes a third adhesive portion that contacts the skin and adheres to the skin.
  • the contact portion can be fixed to the skin by the third adhesive portion, and therefore, during the work such as forming the tissue fluid extraction site and attaching the collecting member to the tissue fluid extraction site. It can suppress that a contact part remove
  • the collection member is attached to the tissue fluid extraction site by the tissue fluid collection device having the above-described configuration, and at least one of the contact portion and the collection member holding portion is collected. While the member is attached to the tissue fluid extraction site, the component is separated from the skin, and components contained in the tissue fluid collected by the collection member attached to the tissue fluid extraction site for 1 hour or more are measured.
  • the tissue fluid collection device having the above-described configuration is used to attach the collection member to the tissue fluid extraction site, whereby the skin permeation enhancement process is performed using the contact portion as a position reference.
  • the tissue fluid extraction site is formed by the tissue fluid extraction site and attach the collection member to the skin using the contact portion as a position reference, so even if the subject cannot visually confirm the tissue fluid extraction site, It can be reliably attached to the tissue fluid extraction site.
  • it is possible to prevent the collection of the tissue fluid in a state where the collection member is attached to a position off the tissue fluid extraction site, so that the reliability of the measurement result of the in vivo component can be improved.
  • the collection member after attaching the collection member to the tissue fluid extraction site by separating at least one of the contact portion and the collection member holding unit from the skin in a state where the collection member is attached to the tissue fluid extraction site, Since at least one of the contact portion and the collection member holding portion that are not used during the collection of tissue fluid can be removed from the skin, the number and weight of members attached to the skin of the subject when collecting the tissue fluid is reduced. Can do. Thereby, the test subject's burden at the time of collecting tissue fluid can be reduced.
  • the component contained in the tissue fluid collected by the collecting member is glucose. If comprised in this way, while improving the reliability of the measurement result of glucose easily, the test subject's burden at the time of collecting the tissue fluid containing glucose can be reduced.
  • FIG. 1 is a perspective view showing an overall configuration of an in-vivo component measurement system according to a first embodiment of the present invention. It is a perspective view which shows the tissue fluid collection device of the in-vivo component measuring system by 1st Embodiment of this invention. It is a top view which shows the tissue fluid collection device of the in-vivo component measuring system by 1st Embodiment of this invention. It is a bottom view which shows the tissue fluid collection device of the in-vivo component measuring system by 1st Embodiment of this invention. It is a side view which shows the tissue fluid collection device of the in-vivo component measurement system by 1st Embodiment of this invention.
  • FIG. 4 is a cross-sectional view taken along line 100-100 in FIG.
  • FIG. 22 is a cross-sectional view taken along the line 400-400 in FIG.
  • the in-vivo component measurement system 1 collects tissue fluid that exits from a region (a micropore formation region 6b) in which a micropore 6a is formed in the skin 6 (see FIG. 14) of a subject.
  • a tissue fluid collecting device 2 for measuring a measuring device 3 for measuring the amount of a predetermined component (glucose in the first embodiment) in the tissue fluid collected by the tissue fluid collecting device 2, and a skin 6 of the subject.
  • a fine hole forming device 4 for forming the holes 6a.
  • the tissue fluid collecting device 2 includes a collecting member 21 for collecting the tissue fluid and a main body 22 for holding the collecting member 21.
  • the tissue fluid collecting device 2 is stored in a state of being packaged in a packaging member 23 (see FIG. 7), and is taken out from the packaging member 23 and used when collecting the tissue fluid.
  • the collecting member 21 is composed of a gel member 24 made of hygroscopic polyvinyl alcohol capable of holding tissue fluid extracted from the skin 6 of the subject, and a gel holding member 25 holding the gel member 24.
  • the gel holding member 25 includes a film-shaped dressing tape 25a having a small thickness T1 (for example, about 70 ⁇ m) and having elasticity, and a frame-shaped frame member 25b that supports the dressing tape 25a. Consists of.
  • the dressing tape 25a is impermeable to moisture.
  • the frame member 25b is configured to be harder than the dressing tape 25a and not easily deformed.
  • the frame member 25b is made of, for example, a PET resin having a thickness T2 larger than the thickness T1 of the dressing tape 25a.
  • the gel member 24 is hold
  • the surface on the skin contact side of the gel holding member 25 composed of the dressing tape 25a and the frame member 25b (the exposed surface in FIGS. 1 to 6 and the back surface of the exposed surface in FIG. 4) is the entire surface. It has adhesiveness and constitutes the bonding portion 21a.
  • the surface of the collecting member 21 on the non-skin contact side (the exposed surface in FIGS. 1 to 6 and the back surface of the exposed surface in FIG. 4) is partially sticky. And constitutes an adhesive portion 21b (see FIGS. 1 and 4).
  • the bonding area of the bonding portion 21a to the skin 6 is larger than the bonding area of the bonding portion 21b to the main body 22 (collecting member holding portion 27 described later). It is configured. That is, the adhesive force of the adhesive part 21a to the skin 6 is larger than the adhesive force of the adhesive part 21b to the collecting member holding part 27.
  • the main body 22 is in contact with the skin 6 and functions as a position reference for the puncture position of the micropore forming device 4 and the attachment position of the gel member 24, a collection member holding part 27 for holding the collection member 21, And a hinge portion 28 for rotating the collecting member holding portion 27 with respect to the abutting portion 26.
  • the contact part 26, the collecting member holding part 27, and the hinge part 28 are integrally formed by resin molding.
  • the abutting portion 26 is formed in a frame shape having an opening 26 a larger than the collecting member holding portion 27 in the central portion.
  • the surface on the skin contact side of the contact portion 26 (the lower surface in FIGS. 1 to 6) has adhesiveness and constitutes an adhesive portion 26b.
  • the main body 22 can be fixed to the skin 6 of the subject by the adhesive portion 26b.
  • Concave engagement portions 26c that engage with a micro-hole forming device 4 described later face each other on the non-skin contact surface (the upper surface in FIGS. 1 to 6) of the frame-shaped contact portion 26.
  • a pair is formed on two sides.
  • the collecting member holding part 27 is formed in a flat plate shape, and the skin contact side surface 27a of the collecting member holding part 27 and the non-skin contact side face (adhesive part 21b) of the collecting member 21 are bonded. As a result, the collecting member holding unit 27 holds the collecting member 21.
  • the collection member holding part 27 is in a first position P (see FIG. 7) where the hinge part 28 is folded and a second position Q (see FIG. 6) where the hinge part 28 is opened. It is configured to be displaceable. As shown in FIG. 7, in the first position P, the collection member holding portion 27 is disposed in the opening 26 a of the contact portion 26 and the gel member of the collection member 21 held by the collection member holding portion 27. 24 is configured to be located at the center of the opening 26a.
  • the collection member 21 adheres to the skin contact side surface of the collection member holding portion 27.
  • the surface 21b (see FIGS. 1 and 4) is adhered, and the surface (adhesive portion 21a) on the skin contact portion side of the collecting member 21 and the gel member 24 are covered with the release sheet 29a. Since the gel member 24 is covered with the release sheet 29a, the gel member 24 and the packaging member 23 are prevented from directly contacting each other. Further, the skin contact side surface (adhesive portion 26b) of the contact portion 26 is also covered with the release sheet 29b.
  • the measuring apparatus 3 includes a display unit 31, a recording unit 32, an analysis unit 33, a power supply 34, an installation unit 35 for installing the sensor chip 200 and the collecting member 21.
  • the electric circuit 36 connected to the sensor chip 200 installed in the installation unit 35, the operation button 37 for the user (subject) to operate the measuring device 3, and the timer unit 38 are provided.
  • the display unit 31 has a function of displaying the measurement result by the analysis unit 33 and the data recorded in the recording unit 32.
  • the recording unit 32 is provided for storing past data.
  • the analysis unit 33 has a function of calculating the glucose concentration and the electrolyte (NaCl) concentration based on the output value of the electric circuit 36.
  • the installation part 35 has a concave shape, and is configured such that the sensor chip 200 and the collection member 21 can be installed.
  • the electric circuit 36 includes a glucose measurement circuit 36a and an electrolyte measurement circuit 36b.
  • the glucose measurement circuit 36 a includes terminals 36 c and 36 d exposed in the installation part 35
  • the electrolyte measurement circuit 36 b includes terminals 36 e and 36 f exposed in the installation part 35.
  • the electric circuit 36 includes a switch 36g for switching between the glucose measurement circuit 36a and the electrolyte measurement circuit 36b.
  • the user can switch the glucose measurement circuit 36a and the electrolyte measurement circuit 36b by operating the operation button 37 to operate the switch 36g.
  • the operation button 37 is provided for operations such as switching of the switch 36g, switching of display of the display unit 31, and setting of the timer unit 38.
  • the timer unit 38 has a function of notifying the user of the extraction end time in order to end the collection at a predetermined time after the glucose collection is started.
  • the sensor chip 200 includes a plastic substrate 201, a pair of glucose measurement electrodes 202 provided on the upper surface of the substrate 201, and a pair of electrolyte measurement electrodes 203 provided on the upper surface of the substrate 201.
  • the glucose measuring electrode 202 is composed of a working electrode 202a in which a GOD enzyme film (GOD: glucose oxidase) is formed on a platinum electrode and a counter electrode 202b composed of a platinum electrode, and the electrolyte measuring electrode 203 is composed of silver / silver chloride.
  • a working electrode 203a and a counter electrode 203b made of silver / silver chloride.
  • the working electrode 202a and the counter electrode 202b of the glucose measuring electrode 202 are in contact with the terminals 36c and 36d of the glucose measuring circuit 36a, respectively. It is configured.
  • the working electrode 203a and the counter electrode 203b of the electrolyte measurement electrode 203 are in contact with the terminals 36e and 36f of the electrolyte measurement circuit 36b, respectively, in a state where the sensor chip 200 is installed on the installation unit 35 of the measurement device 3. Is configured to do.
  • the micropore forming device 4 is mounted with a sterilized microneedle chip 5 and the microneedle 5a of the microneedle chip 5 is attached to the epidermis of the living body (subject's skin). It is an apparatus for forming tissue fluid extraction holes (micropores 6a) in the skin 6 of a subject by being brought into contact with the skin 6).
  • tissue fluid extraction holes micropores 6a
  • the region in which the micro holes 6a are formed is referred to as a micro hole forming region 6b.
  • the micro-hole forming device 4 includes a housing 4a, a release button 4b provided on the surface of the housing 4a, an array chuck 4c and a spring member 4d provided inside the housing 4a. It has.
  • the spring member 4d has a function of urging the array chuck 4c downward.
  • the array chuck 4c can be mounted with a fine needle chip 5 at the lower end.
  • the micro-hole forming device 4 has a fixing mechanism (not shown) for fixing the array chuck 4c in a state where it is pushed upward against the urging force of the spring member 4d, and the user (subject) releases it. By pressing the button 4b, the array chuck 4c is fixed by the fixing mechanism.
  • a rib formed in a circumferential shape so as to protrude downward is formed on the lower surface of the skin guide 4e attached to the lower portion of the microhole forming device 4.
  • 4f is provided.
  • the shape of the rib 4f is formed to match the shape of the pair of concave engaging portions 26c provided on the non-skin contact surface of the contact portion 26 of the tissue fluid collecting device 2. That is, the skin guide 4e (micropore forming device 4) is positioned with respect to the contact portion 26 by engaging the circumferential rib 4f of the skin guide 4e with the engagement portion 26c of the pair of contact portions 26. It is possible.
  • the fine hole forming region 6b It is configured to be formed at the center position of the opening 26a.
  • the subject takes out the tissue fluid collecting device 2 from the packaging member 23 (see FIG. 7). Then, as shown in FIG. 15, the contact portion 26 of the main body 22 of the tissue fluid collection device 2 is attached to the skin 6 with the adhesive portion 26 b exposed by peeling the release sheet 29 b. At this time, the main body 22 is arranged and attached so that the part from which the tissue fluid is to be extracted is arranged in the center of the opening 26 a of the contact part 26. The subject also exposes the adhesive portion 21a of the gel member 24 and the collection member 21 by peeling off the release sheet 29a.
  • the subject opens the hinge portion 28 and rotates the collection member holding portion 27 so that the rib 4 f of the micropore forming device 4 is positioned at the second position Q.
  • the contact portion 26 is engaged with a concave engagement portion 26 c of the contact portion 26.
  • the fine hole forming device 4 is positioned with respect to the contact portion 26.
  • pressing the release button 4b releases the fixation of the array chuck 4c by a fixing mechanism (not shown).
  • the microneedle tip 5 collides with the skin 6, and a micropore forming region 6 b is formed in the skin 6.
  • the fine hole forming region 6 b is formed at the center position of the opening 26 a of the contact portion 26.
  • the subject removes the fine hole forming device 4 and the fine needle tip 5 from the skin 6.
  • the subject rotates the collection member holding portion 27 by folding the hinge portion 28 to the first position P.
  • the gel member 24 of the collecting member 21 held by the collecting member holding portion 27 is arranged on the micropore forming region 6b.
  • the release sheet 29a is peeled off before puncturing, but the release sheet 29a may be peeled off after puncturing.
  • the adhesive portion 21a of the collection member 21 is in a state where the gel member 24 is disposed on the micropore forming region 6b.
  • the gel member 24 is adhered to the skin 6 in a region around the gel member 24 (such as a portion of the frame member 25b).
  • the gel holding member is as much as the thickness of the gel member 24 with the edge of the gel holding member 25 adhered to the skin 6. Even when the height of the central portion 25 (the portion of the dressing tape 25a) rises, the gel member 24 can be held without difficulty by the dressing tape 25a extending.
  • the subject removes the main body 22 that is not used during the collection of the tissue fluid away from the skin 6.
  • the collecting member 21 is bonded to the surface 27a of the collecting member holding portion 27 by the bonding force of the bonding portion 21b (see FIGS. 1 and 4), but the bonding force of the bonding portion 21b to the collecting member holding portion 27 is the bonding portion 21a. It is smaller than the adhesive force to the skin 6. For this reason, when a force is applied to the main body 22 so as to separate the main body 22 from the skin 6, the collecting member 21 remains attached to the skin 6, and the adhesion between the collecting member 21 and the surface 27 a of the collecting member holding portion 27 is released. . Thereby, it is possible to remove the main body 22 which is not necessary for collecting the tissue fluid while the collecting member 21 which is necessary for collecting the tissue fluid is adhered to the skin 6.
  • the subject is left for a predetermined time (about 1 to 3 hours) in a state where the gel member 24 is accurately placed in the micropore formation region 6b. During this time, the tissue fluid extracted from the micropore formation region 6 b is collected in the gel member 24. Then, after a predetermined time has elapsed, the subject removes the collection member 21 from the skin 6.
  • the subject measures the in-vivo components collected by the collecting member 21 over a predetermined time using the measuring device 3 (measurement of glucose concentration).
  • the subject installs the sensor chip 200 on the installation unit 35 of the measuring apparatus 3 and installs the collection member 21 after extraction on the sensor chip 200.
  • the glucose measuring circuit 36a of the measuring device 3, the glucose measuring electrode 202 of the sensor chip 200, and the gel member 24 of the collecting member 21 constitute a first circuit
  • the electrolyte measurement electrode 203 of the sensor chip 200 and the gel member 24 of the collection member 21 constitute a second circuit.
  • the test subject When measuring the extracted glucose concentration, the test subject switches the switch 36g to the glucose measurement circuit 36a by the operation button 37 and instructs the start of measurement. As a result, a constant voltage having a predetermined value is applied to the first circuit, and the current value detected by the ammeter is input to the analysis unit 33.
  • the analysis unit 33 stores a function based on the relationship between the current value and the glucose concentration.
  • the analysis unit 33 calculates the glucose concentration in the gel member 24 based on the stored function and the input current value.
  • the electrolyte concentration contained in the gel member 24 can be measured by the measuring device 3.
  • the test subject switches the switch 36g to the electrolyte measurement circuit 36b by the operation button 37 and instructs the start of measurement.
  • the electromotive force derived from the electrolyte generated in the second circuit is detected by the voltmeter, and the voltage value detected by the voltmeter is input to the analysis unit 33.
  • the detected voltage value is proportional to the electrolyte concentration contained in the gel member 24, similarly to the glucose concentration. Therefore, the analysis unit 33 stores a function based on the relationship between the voltage value and the electrolyte concentration.
  • the analysis unit 33 stores the function in the gel member 24 based on the stored function and the input voltage value.
  • the electrolyte concentration is calculated.
  • the micropore formation region 6b is formed by the micropore forming device 4 with the contact portion 26 as a position reference in a state where the contact portion 26 is in contact with the skin 6 in advance.
  • a collection member holding portion 27 configured to allow the collection member 21 to adhere to the micropore forming region 6b is provided with the contact portion 26 in contact with the skin 6 as a position reference.
  • the collection member 21 can be made to adhere to the micropore formation area
  • At least one of the contact part 26 and the collection member holding part 27 that are not used during the collection of the tissue fluid can be removed from the skin 6.
  • the number and weight of members attached to the skin 6 can be reduced. Accordingly, the number and weight of members attached to the skin 6 of the subject when collecting the tissue fluid can be minimized, so that the burden on the subject when collecting the tissue fluid can be reduced.
  • the fine hole forming region 6b is formed in a state where the rib 4f of the fine hole forming device 4 and the concave engaging portion 26c of the contact portion 26 are engaged. It is configured. With this configuration, the subject engages the micropore forming device 4 with respect to the abutting portion 26 by engaging the rib 4f of the micropore forming device 4 with the concave engaging portion 26c of the abutting portion 26. Therefore, the minute hole forming region 6b can be easily and surely formed at the same position (center position of the opening 26a) with respect to the contact portion 26.
  • the collection member 21 when the collection member 21 is attached to the micropore formation region 6b, the collection member 21 is adhered to the micropore formation region 6b, and the collection member holding portion 27 is When separated from the skin 6, the collecting member holding part 27 and the collecting member 21 are configured to be unbonded. With this configuration, the collecting member 21 can be left adhered and adhered to the micropore forming region 6b only by a simple operation of pressing the collecting member holding portion 27 against the skin 6 and then separating it. . Thereby, the test subject's burden at the time of collecting tissue fluid can further be reduced.
  • the adhesive force with respect to the skin 6 of the adhesion part 21a of the collection member 21 is made larger than the adhesion force with respect to the collection member holding
  • the adhesive strength of the adhesive portion 21a is greater than the adhesive strength of the adhesive portion 21b. It can be left adhered to (micropore forming region 6b).
  • the adhesion area between the adhesion part 21 a of the collection member 21 and the skin 6 is larger than the adhesion area between the adhesion part 21 b of the collection member 21 and the collection member holding part 27.
  • the gel holding member 25 is formed in a film shape having a small weight and thickness by forming the gel holding member 25 in a film shape. Even when the state where the gel member 24 and the film-like gel holding member 25 are attached to the skin 6 continues, the burden on the subject can be reduced.
  • the collection member holding portion 27 and the abutting portion 26 are integrally formed, whereby an increase in the number of parts can be suppressed.
  • the user since it is possible to suppress an increase in the number of parts handled by the subject, the user can easily collect the tissue fluid.
  • the collecting member holding portion 27 is moved from the contact portion 26 to the first position P where the hinge portion 28 is folded and the second position where the hinge portion 28 is opened.
  • the microhole forming region 4b is formed by the microhole forming device 4 in a state where the collecting member holding portion 27 is located at the second position Q, and the collecting member holding portion 27 is in the first position.
  • the collecting member 21 held by the collecting member holding part 27 in a state positioned at P is configured to adhere to the micropore forming region 6b.
  • the test subject forms the micropore forming region 6b in a state where the collecting member holding portion 27 is positioned at the first position P, and then positions the collecting member holding portion 27 at the second position Q.
  • the gel member 24 of the collecting member 21 can be attached to the micropore forming region 6b.
  • the subject can collect tissue fluid by attaching the gel member 24 of the collection member 21 to the micropore formation region 6b accurately by a simple operation.
  • the tissue fluid is extracted from the skin 6 through the micropores 6 a by collecting the tissue fluid that exits from the micropore formation region 6 b formed in the skin 6 by the micropore forming device 4. Since it becomes easy to come out, the tissue fluid can be easily collected in the gel member 24.
  • the contact portion 26 by providing the contact portion 26 with the adhesive portion 26b that contacts the skin 6 and adheres to the skin 6, the contact portion 26 is attached to the skin 6 by the adhesive portion 26b. Since it can be fixed, it is possible to prevent the contact portion 26 from coming off the skin 6 during operations such as forming the micropore formation region 6b and attaching the collecting member 21 to the micropore formation region 6b. Can do. Accordingly, the subject can collect the tissue fluid by easily and reliably attaching the collecting member 21 to the micropore forming region 6b.
  • the collection member 301 is a gel member 24 and a gel holding member made of an aluminum film that holds the gel member 24. 302 and a sheet member 303 for preventing the gel holding member 302 from directly contacting the skin 6.
  • a part of the surface of the gel holding member 302 on the non-skin contact side has adhesiveness, and constitutes an adhesive portion 302a.
  • the gel holding member 302 is bonded to the surface 27a of the collecting member holding portion 27 by the adhesive force of the bonding portion 302a.
  • An opening 303a is provided at the center of the sheet member 303, and the gel member 24 protrudes to the surface of the sheet member 303 on the skin contact side through the opening 303a.
  • the entire surface of the sheet member 303 on the non-skin contact side (the gel holding member 302 side) has adhesiveness and constitutes an adhesive portion 303b.
  • the sheet member 303 is bonded to the gel holding member 302 by the bonding force of the bonding portion 303b. Further, the entire surface of the sheet member 303 on the skin contact side has adhesiveness, and constitutes an adhesive portion 303c.
  • the sheet member 303 can be attached to the skin 6 by the adhesive force of the adhesive portion 303c.
  • the release sheet 29a is adhered to the adhesive portion 303c so as to cover the adhesive portion 303c and the gel member 24 of the sheet member 303.
  • the adhesive force of the adhesive part 303c of the sheet member 303 to the skin 6 and the adhesive force of the sheet member 303 to the gel holding member 302 are larger than the adhesive force of the adhesive part 302a of the gel holding member 302 to the collecting member holding part 27.
  • the subject takes out the tissue fluid collecting device 300 from the packaging member 23 (see FIG. 7). Then, as shown in FIG. 25, the contact portion 26 of the main body 22 of the tissue fluid collecting device 300 is attached to the skin 6 with the adhesive portion 26 b exposed by peeling the release sheet 29 b (see FIG. 20). The subject also exposes the adhesive member 303c of the gel member 24 and the sheet member 303 by peeling off the release sheet 29a.
  • the subject engages the rib 4 f of the micropore forming device 4 with the engaging portion 26 c of the abutting portion 26 to bring the micropore forming device 4 to the abutting portion 26.
  • puncture is performed by the micropore forming device 4.
  • the fine hole forming region 6 b is formed at the center position of the opening 26 a of the contact portion 26.
  • the subject removes the fine hole forming device 4 and the fine needle tip 5 from the skin 6.
  • the subject rotates the collection member holding portion 27 by closing the hinge portion 28 so as to be positioned from the second position Q to the first position P.
  • the gel member 24 held by the collecting member holding portion 27 and protruding to the skin 6 side of the sheet member 303 through the opening 303a of the sheet member 303 is arranged on the micropore forming region 6b.
  • the adhesive portion 303c of the sheet member 303 is adhered to the skin 6 in a state where the gel member 24 is disposed on the micropore forming region 6b.
  • the subject removes the main body 22 that is not used during the collection of the tissue fluid while separating it from the skin 6.
  • the collecting member 301 is adhered to the collecting member holding part 27 by the adhesive force of the adhesive part 302a of the gel holding member 302.
  • the adhesive force of the adhesive part 302a to the collecting member holding part 27 is the adhesion of the adhesive part 303c of the sheet member 303. It is smaller than the adhesive force to the skin 6 and the adhesive force to the gel holding member 302 of the adhesive portion 303b of the sheet member 303.
  • the collecting member 301 and the collecting member holding unit 27 are attached in a state where the gel holding member 302 is adhered to the sheet member 303 and the sheet member 303 is attached to the skin 6. (Bonding by the bonding portion 302a) is released. Thereby, it is possible to remove the main body 22 that is not necessary for collecting the tissue fluid while the collecting member 301 is attached to the skin 6.
  • the subject holds the gel holding the gel member 24 among the collection members 301.
  • the member 302 is removed from the skin 6.
  • the sheet member 303 remains attached to the skin 6.
  • the subject measures the in-vivo components collected in the gel member 24 (measurement of glucose concentration) using the measuring device 3.
  • the measurement of the glucose concentration is the same as in the first embodiment.
  • the gel holding member 302 and the sheet member 303 may be removed from the skin 6 together, and then the sheet member 303 and the gel holding member 302 may be separated to perform measurement.
  • the gel holding member 302 is directly adhered to the skin 6 by providing the sheet member 303 for preventing the gel holding member 302 from directly contacting the skin 6. It is possible to prevent foreign substances such as keratin on the skin 6 from adhering to the holding member 302. Thereby, when the gel member 24 and the gel holding member 302 are collectively measured by the measuring device 3, it is possible to prevent the measurement result from being shifted due to the foreign matter attached to the gel holding member 302.
  • the tissue fluid collection device 500 includes a collection member 21 for collecting tissue fluid, a contact member 501 that contacts the skin 6, and a collection member holding that holds the collection member 21. Member 502.
  • the contact member 501 is a recess that engages with an opening 501a formed at the center, an adhesive portion 501b provided on the surface on the skin contact side, and a rib 4f (see FIG. 1) of the micropore forming device 4. And an engaging portion 501c having a shape.
  • the shape of the outer edge of the collection member holding member 502 is substantially the same as the shape of the inner edge of the opening 501a of the contact member 501, and the size of the opening 501a of the contact member 501 is larger. Is also configured to be slightly smaller.
  • the gel member 24 of the collection member 21 held by the collection member holding member 502 is positioned at the center position of the opening 501a. It is configured as follows.
  • the subject takes out the tissue fluid collecting device 500 from the packaging member 23 (see FIG. 7). Then, as in the first embodiment, the contact member 501 is attached to the skin 6 with the adhesive portion 501b exposed by peeling off the release sheet 29b (see FIG. 30) of the contact member 501.
  • the subject engages the rib 4f of the microhole forming device 4 and the engaging portion 501c of the contact member 501, and positions the microhole forming device 4 with respect to the contact member 501. Puncturing is performed by the forming device 4. Thereby, the fine hole forming region 6 b is formed at the center position of the opening 501 a of the contact member 501. Thereafter, the subject removes the fine hole forming device 4 and the fine needle tip 5 from the skin 6.
  • the test subject exposes the adhesive member 21 a of the gel member 24 and the collecting member 21 by peeling the release sheet 29 a of the collecting member holding member 502. Then, as shown in FIG. 31, the collection member holding member 502 is disposed in the opening 501a of the contact member 501 so that the outer edge of the collection member holding member 502 and the inner edge of the opening 501a of the contact member 501 are aligned. . As a result, the gel member 24 held by the collecting member holding member 502 is arranged on the micropore forming region 6b. When the subject presses the collection member holding member 502 further toward the skin 6, the adhesive portion 21a of the gel holding member 25 is adhered to the skin 6 in a state where the gel member 24 is disposed on the micropore forming region 6b. .
  • the test subject removes the contact member 501 and the collection member holding member 502 that are not used during the collection of the tissue fluid away from the skin 6.
  • the collecting member 21 is bonded to the collecting member holding member 502 by the bonding force of the bonding portion 21b, but the bonding force of the bonding portion 21b to the collecting member holding member 502 is smaller than the bonding force of the bonding portion 21a to the skin 6. Therefore, when the collecting member holding member 502 is separated from the skin 6, the collecting member 21 and the collecting member holding member 502 are detached from each other with the collecting member 21 attached to the skin 6. Further, the contact member 501 can be easily removed from the skin 6.
  • the collection member 21 that has collected the tissue fluid is subjected to the same measurement as in the first embodiment using the measurement device 3.
  • the collection member holding member 502 and the contact member 501 are formed separately, and the inner edge of the opening 501a of the contact member 501 is formed so as to correspond to the shape of the outer edge of the collection member holding member 502. Form a shape.
  • the collecting member holding member 502 and the contact member 501 are separate, the collecting member holding member 502 is collected so that the shape of the outer edge of the collecting member holding member 502 matches the shape of the inner edge of the opening 501a of the contacting member 501.
  • the collecting member holding member 502 is placed at a predetermined position with respect to the abutting member 501 (the gel member 24 of the collecting member 21 is placed in the micropore formation region 6b. Position). As a result, the subject can collect the tissue fluid by reliably attaching the collection member 21 to the micropore formation region 6b.
  • the micropore forming region 6b is formed using the micropore forming device 4 is shown.
  • passive diffusion may be promoted by irradiating the skin with ultrasonic waves to reduce the barrier function of the skin, and an enhancer for promoting percutaneous movement of the tissue fluid to the tissue fluid extraction site of the skin (Surfactant such as alcohol) may be added.
  • the tissue fluid is collected using the gel member 24.
  • the present invention is not limited to this, and the mesh sheet, the sheet-like piece of paper, or the non-sheet-like piece of paper is used. Or nylon may be used.
  • the present invention is not limited to this, and a gel made of cellulose or polyacrylic acid is used. Also good.
  • the present invention is not limited to this, and the amount of a substance other than glucose contained in the tissue fluid may be measured.
  • substances measured by the present invention include biochemical components and drugs administered to subjects.
  • biochemical components include proteins such as albumin, globulin, and enzymes, which are a kind of biochemical components.
  • biochemical components other than protein include creatinine, creatine, uric acid, amino acids, fructose, galactose, pentose, glycogen, lactic acid, pyruvic acid, and ketone bodies.
  • the drug include digitalis preparations, theophylline, arrhythmic agents, antiepileptic agents, amino acid saccharide antibiotics, glycopeptide antibiotics, antithrombotic agents, and immunosuppressive agents.
  • the shape of the inner edge of the opening 501a of the contact member 501 is formed so as to correspond to the shape of the outer edge of the collection member holding member 502. It was configured to be able to be positioned at a predetermined position with respect to 501 (a position where the gel member 24 is positioned in the micropore forming region 6b).
  • the present invention is not limited to this, and a contact member 601 is provided with a hole-like engaging portion 601a and a collecting member holding member, as in the tissue fluid collecting device 600 of the modified example of the third embodiment shown in FIG.
  • the member 602 may be provided with a boss-like engagement portion 602 a at a position corresponding to the engagement portion 601 a of the contact member 601.
  • the collecting member holding member 602 can be easily moved to a predetermined position with respect to the contacting member 601 by engaging the engaging portion 601a of the abutting member 601 with the engaging portion 602a of the collecting member holding member 602. It can be positioned at a position where the gel member 24 is located in the micropore forming region 6b.
  • the contact member and the collection member holding member are separate, a mark corresponding to each other is attached to each of the contact member and the collection member holding member so that the subject can collect the mark as a mark.
  • the member holding member may be configured to be positioned at a predetermined position with respect to the contact member (a position where the collecting member is located at the tissue fluid extraction site). Further, when the contact member and the collection member holding member are separate, after the collection member is attached to the skin, only one of the contact member and the collection member holding member may be removed from the skin.
  • the glucose concentration of the tissue fluid collected by the collecting member is directly measured.
  • the present invention is not limited to this, and glucose is replaced with another substance. Later, the concentration of the substance may be measured.
  • maintenance part 27 and the contact part 26 showed the example which does not engage in the 1st position P
  • this invention is not limited to this, 1st Embodiment shown in FIG.
  • the collection member holding unit 27 and the contact unit 26 may be engaged at the first position P where the hinge unit 28 is closed.
  • the collecting member holding portion 27 is provided with a convex engaging portion 701
  • the contact portion 26 is a position corresponding to the engaging portion 701 of the collecting member holding portion 27. Is provided with a notch-shaped engaging portion 702.
  • the length L1 from the bent portion of the hinge portion 28 to the distal end portion of the engaging portion 701 is configured to be slightly larger than the length L2 from the bent portion of the hinge portion 28 to the distal end portion of the engaging portion 702. Has been. Accordingly, when the collection member holding portion 27 is moved to the first position P by bending the hinge portion 28 at the bent portion, the distal end portion of the engaging portion 701 bends below the distal end portion of the engaging portion 702. The engaging portion 701 and the engaging portion 702 can be engaged with each other by entering. By configuring in this manner, the subject confirms that the engaging portion 701 and the engaging portion 702 are engaged with each other until the collecting member 24 held by the collecting member holding portion 27 comes into contact with the skin.
  • Tissue fluid collection apparatus 21 Collection member 21a Adhesion part (1st adhesion part) 21b Bonding part (second bonding part) 24 Gel member (collector) 25 Gel holding member (collector holding part) 26 Contact part (contact member) 26b Bonding part (third bonding part) 26c engagement part (first positioning part) 27 Collecting member holding part (collecting member holding member) 28 Hinge part 3 Measuring device 4 Micropore forming device (skin permeation enhancement processing device) 4f Rib (second positioning part) 6 Skin 6a Micropore 6b Micropore formation region (tissue fluid extraction site) 300 tissue fluid collection device 301 collection member 302 gel holding member (collecting body holding unit) 302a Bonding part (second bonding part) 303 Sheet member 303c Bonding part (first bonding part) 500 Tissue fluid collection device 501 Contact member 501b Adhesive part (third adhesive part) 502 Collection member holding member 600 Tissue fluid collection device 601 Contact member 602 Collection member

Abstract

Le système de mesure de composant in vivo met en œuvre un élément de contact qui se trouve en contact avec la peau d'un organisme; un dispositif de traitement pour faciliter la pénétration de la peau qui, lorsqu'un élément de contact est préalablement mis en contact avec la peau, forme un emplacement d'extraction de fluide tissulaire, utilisant l'élément de contact comme référence d'emplacement; un élément de collecte qui collecte du fluide tissulaire; un élément de collecte-élément de soutien, qui, tout en soutenant un élément de collecte, utilise comme référence d'emplacement l'élément de contact mis en contact avec la peau, et est structuré de façon à pouvoir faire adhérer l'élément de collecte à un emplacement d'extraction de fluide tissulaire; et un dispositif de mesure mesurant un composant contenu dans un fluide tissulaire collecté par l'élément de collecte. Soit l'élément de contact, soit l'élément de collecte-élément de soutien, soit chacun des deux, lorsqu'ils font adhérer l'élément de collecte à un emplacement d'extraction de fluide tissulaire, sont structurés de sorte à pouvoir être détachés de la peau.
PCT/JP2010/052826 2009-02-27 2010-02-24 Système de mesure de composant in vivo, dispositif de collecte de fluide tissulaire et procédé de mesure de composant in vivo WO2010098339A1 (fr)

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WO2014050290A1 (fr) * 2012-09-27 2014-04-03 シスメックス株式会社 Ruban de positionnement
JP2014163845A (ja) * 2013-02-26 2014-09-08 Sysmex Corp 体液収集体保持シートの支持キット、体液収集体の保護方法、及び体液収集体の取出方法
EP3932463A1 (fr) * 2013-01-08 2022-01-05 Kindeva Drug Delivery L.P. Applicateur pour appliquer un dispositif de micro-aiguille sur la peau
JP2022520812A (ja) * 2019-02-14 2022-04-01 ベクトン・ディキンソン・アンド・カンパニー 回転して接続する毛細管収集器
US11877848B2 (en) 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample
US11964121B2 (en) 2021-10-13 2024-04-23 Satio, Inc. Mono dose dermal patch for pharmaceutical delivery

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JPWO2014050290A1 (ja) * 2012-09-27 2016-08-22 シスメックス株式会社 位置決めテープ
EP3932463A1 (fr) * 2013-01-08 2022-01-05 Kindeva Drug Delivery L.P. Applicateur pour appliquer un dispositif de micro-aiguille sur la peau
JP2014163845A (ja) * 2013-02-26 2014-09-08 Sysmex Corp 体液収集体保持シートの支持キット、体液収集体の保護方法、及び体液収集体の取出方法
JP2022520812A (ja) * 2019-02-14 2022-04-01 ベクトン・ディキンソン・アンド・カンパニー 回転して接続する毛細管収集器
JP7244662B2 (ja) 2019-02-14 2023-03-22 ベクトン・ディキンソン・アンド・カンパニー 回転して接続する毛細管収集器
US11964121B2 (en) 2021-10-13 2024-04-23 Satio, Inc. Mono dose dermal patch for pharmaceutical delivery
US11877848B2 (en) 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample

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