JP4643768B2 - In vivo component measurement system, tissue fluid collection device, and in vivo component measurement method - Google Patents

In vivo component measurement system, tissue fluid collection device, and in vivo component measurement method Download PDF

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JP4643768B2
JP4643768B2 JP2010538242A JP2010538242A JP4643768B2 JP 4643768 B2 JP4643768 B2 JP 4643768B2 JP 2010538242 A JP2010538242 A JP 2010538242A JP 2010538242 A JP2010538242 A JP 2010538242A JP 4643768 B2 JP4643768 B2 JP 4643768B2
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義裕 朝倉
利幸 佐藤
淳 樽谷
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Description

この発明は、生体内成分測定システム、組織液収集装置および生体内成分測定方法に関し、特に、組織液を収集する収集部材を備えた生体内成分測定システム、組織液収集装置、および組織液収集装置を用いた生体内成分測定方法に関する。   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 for collecting tissue fluid The present invention relates to a method for measuring internal components.

従来、組織液を収集する収集部材を備えた生体内成分測定システムが知られている（たとえば、特許文献１および２参照）。これらの特許文献１および２では、被験者の皮膚に、組織液を抽出し易くする皮膚透過促進処理を行って組織液抽出部位を形成し、その組織液抽出部位に組織液を収集する収集部材を付着させることにより、収集部材に組織液を収集している。そして、収集部材に収集された組織液を用いて生体内成分を測定している。   Conventionally, an in-vivo component measurement system including a collecting member that collects tissue fluid is known (see, for example, Patent Documents 1 and 2). In these 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. And the in-vivo component is measured using the tissue fluid collected by the collection member.

上記特許文献１には、被験者の皮膚に粒子を衝突させることにより被験者の皮膚に微小経路（組織液抽出部位）を形成し、その微小経路にゲル（収集部材）を付着させることにより、微小経路を介して抽出した組織液をゲルに収集させる構成が開示されている。   In Patent Document 1, a micropath (tissue fluid extraction site) is formed in the subject's skin by colliding particles with the subject's skin, and a gel (collecting member) is attached to the micropath, thereby reducing the micropath. The structure which makes the gel collect | recover the tissue fluid extracted via is disclosed.

また、上記特許文献２では、微細孔形成装置を用いて被験者の皮膚に微細孔を形成し、その微細孔形成領域（組織液抽出部位）に抽出カートリッジ（収集部材）を付着させることにより、微細孔形成領域を介して抽出した組織液を抽出カートリッジに収集させることが開示されている。具体的には、上記特許文献２には、被験者の腕に巻きつけるためのベルト部と、抽出カートリッジを保持する本体部と、開口部が設けられた受け部と、受け部に対して本体部を回動可能に支持するヒンジ部とを含む血糖値分析装置が開示されている。上記特許文献２では、受け部の開口部を介して開口部内に露出した皮膚に微細孔形成装置により微細孔形成領域が形成される。また、本体部の皮膚側の面には抽出カートリッジがセットされており、本体部を受け部の開口部側に回動させることにより、抽出カートリッジが開口部内に露出した皮膚に形成された微細孔形成領域に付着するように構成されている。   Moreover, in the said patent document 2, 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 | part). It is disclosed that tissue fluid extracted through a formation region is collected in an extraction cartridge. Specifically, in the above-mentioned Patent Document 2, 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. In Patent Document 2, 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. In addition, 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.

特表２００５−５１３４２８号公報JP-T-2005-513428 特開２００７−２３６８４４号公報JP 2007-236844 A

しかしながら、上記特許文献１では、微小経路が形成された領域にどのようにしてゲルを付着させるかについては何ら開示していない。微小経路は目視では確認できないため、被験者は、正確にゲルを微小経路に付着させることが困難であると考えられる。このため、被験者がゲルを微小経路とずれた位置に付着してしまった場合には、組織液の収集を正常に行うことができないので、生体内成分の測定結果の信頼性が低下してしまうという問題点がある。   However, Patent Document 1 does not disclose how to attach a gel to a region where a 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.

その一方、上記特許文献２では、ヒンジ部を介して本体部を回動させれば抽出カートリッジが微細孔形成領域に付着されるので、被験者が目視により微細孔形成領域を確認できない場合であっても、正確に微細孔形成領域に抽出カートリッジを付着させることが可能である。しかしながら、上記特許文献２では、組織液を抽出カートリッジにより収集している間も、組織液の収集に必要な抽出カートリッジのみならず、組織液の収集中は使用されないベルト部、本体部、受け部およびヒンジ部を含む血糖値分析装置を常に装着している必要がある。   On the other hand, in Patent Document 2 described above, 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. However, it is possible to accurately attach the extraction cartridge to the micropore formation region. However, in 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

この発明は、上記のような課題を解決するためになされたものであり、この発明の１つの目的は、生体内成分の測定結果の信頼性を向上させるとともに、組織液を収集する際の被験者の負担が大きくなってしまうことを抑制することが可能な生体内成分測定システム、組織液収集装置および生体内成分測定方法を提供することである。   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.

課題を解決するための手段および発明の効果Means for Solving the Problems and Effects of the Invention

この発明の第１の局面による生体内成分測定システムは、生体の皮膚と当接する当接部材と、予め当接部材が皮膚に当接された状態で、当接部材を位置基準として生体の組織液を抽出し易くする皮膚透過亢進処理を皮膚の所定の部位に対して行うことにより、組織液抽出部位を形成する皮膚透過亢進処理装置と、組織液を収集する収集部材と、収集部材を保持するとともに、皮膚に当接された当接部材を位置基準として、収集部材を組織液抽出部位に付着させることが可能に構成された収集部材保持部材と、収集部材に収集された組織液に含まれる成分を測定する測定装置とを備え、当接部材および収集部材保持部材の少なくともいずれか一方は、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させることが可能に構成されている。   The in-vivo component measurement system according to the first aspect of the present invention 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. That.

この第１の局面による生体内成分測定システムでは、上記のように、予め当接部材が皮膚に当接された状態で、当接部材を位置基準として皮膚透過亢進処理を行うことにより、組織液抽出部位を形成する皮膚透過亢進処理装置と、皮膚に当接された当接部材を位置基準として、収集部材を組織液抽出部位に付着させることが可能に構成された収集部材保持部材とを設けている。このように構成することによって、当接部材を位置基準として皮膚透過亢進処理を行って組織液抽出部位を形成し、かつ、当接部材を位置基準として収集部材を皮膚に付着させることができるので、被験者が組織液抽出部位を目視により確認できない場合であっても、収集部材を確実に組織液抽出部位に付着させることができる。これにより、収集部材が組織液抽出部位から外れた位置に付着した状態で組織液の収集が行われることを防止することができるので、生体内成分の測定結果の信頼性を向上させることができる。また、当接部材および収集部材保持部材の少なくともいずれか一方を、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させることが可能に構成することによって、収集部材を組織液抽出部位に付着させた後は、組織液の収集中には使用されない当接部材および収集部材保持部材の少なくともいずれかを皮膚から取り外すことができるので、組織液を収集する際に被験者の皮膚に取り付けられる部材の数および重量などを減らすことができる。これにより、組織液を収集する際の被験者の負担を軽減することができる。   In the in vivo component measurement system according to the first aspect, as described above, 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. And 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. . By configuring in this way, the skin permeation enhancement process is performed using the contact member as a position reference to form a tissue fluid extraction site, and the collection member can be attached to the skin using the contact member as a position reference. Even when the subject cannot visually confirm the tissue fluid extraction site, the collecting member can be reliably attached to the tissue fluid extraction site. As a result, 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. Further, 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. After attachment, since at least one of the contact member and the collection member holding member that are not used during the collection of the tissue fluid can be removed from the skin, the number of members attached to the skin of the subject when collecting the tissue fluid And weight etc. can be reduced. Thereby, the test subject's burden at the time of collecting tissue fluid can be reduced.

この発明の第２の局面による組織液収集装置は、生体の皮膚に予め当接された状態で、皮膚の所定の部位に組織液を抽出し易くする皮膚透過亢進処理を行うことにより組織液抽出部位を形成する皮膚透過亢進処理装置の位置基準として機能する当接部と、組織液を収集する収集部材と、収集部材を保持するとともに、皮膚に当接された当接部を位置基準として、収集部材を組織液抽出部位に付着することが可能に構成された収集部材保持部とを備え、当接部および収集部材保持部の少なくともいずれか一方は、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させることが可能に構成されている。   A tissue fluid collection device according to a second aspect of the present invention 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.

この第２の局面による組織液収集装置では、上記のように、生体の皮膚に予め当接された状態で、皮膚透過亢進処理を行うことにより組織液抽出部位を形成する皮膚透過亢進処理装置の位置基準として機能する当接部と、皮膚に当接された当接部を位置基準として、収集部材を組織液抽出部位に付着することが可能に構成された収集部材保持部とを設けている。このように構成することによって、当接部を位置基準として皮膚透過亢進処理を行って組織液抽出部位を形成し、かつ、当接部を位置基準として収集部材を皮膚に付着させることができるので、被験者が組織液抽出部位を目視により確認できない場合であっても、収集部材を確実に組織液抽出部位に付着させることができる。これにより、収集部材が組織液抽出部位から外れた位置に付着した状態で組織液の収集が行われることを防止することができるので、生体内成分の測定結果の信頼性を向上させることができる。また、当接部および収集部材保持部の少なくともいずれか一方を、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させることが可能に構成することによって、収集部材を組織液抽出部位に付着させた後は、組織液の収集中には使用されない当接部および収集部材保持部の少なくともいずれかを皮膚から取り外すことができるので、組織液を収集する際に被験者の皮膚に取り付けられる部材の数および重量などを減らすことができる。これにより、組織液を収集する際の被験者の負担を軽減することができる。   In the tissue fluid collection device according to the second aspect, as described above, 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. And 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. By configuring in this way, the skin permeation enhancement process is performed using the contact portion as a position reference to form a tissue fluid extraction site, and the collection member can be attached to the skin using the contact portion as a position reference. Even when the subject cannot visually confirm the tissue fluid extraction site, the collecting member can be reliably attached to the tissue fluid extraction site. As a result, 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. Further, 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. After attachment, since at least one of the contact portion and the collection member holding portion that are not used during the collection of the tissue fluid can be removed from the skin, the number of members attached to the subject's skin when collecting the tissue fluid And weight etc. can be reduced. Thereby, the test subject's burden at the time of collecting tissue fluid can be reduced.

上記第２の局面による組織液収集装置において、好ましくは、当接部および収集部材保持部の両方は、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させることが可能に構成されている。このように構成すれば、収集部材を組織液抽出部位に付着させた後は、組織液の収集中には使用されない当接部および収集部材保持部の両方を皮膚から取り外して、収集部材のみを皮膚に付着させたまま残すことができる。これにより、組織液を収集する際に被験者の皮膚に取り付けられる部材の数および重量などを最小限にすることができるので、組織液を収集する際の被験者の負担をさらに軽減することができる。   In the tissue fluid collection device according to the second aspect, preferably, 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. With this configuration, after the collection member is attached to the tissue fluid extraction site, 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.

上記第２の局面による組織液収集装置において、好ましくは、当接部および皮膚透過亢進処理装置は、それぞれ、皮膚透過亢進処理装置を当接部に対して位置決めするための第１位置決め部および第２位置決め部を有しており、皮膚透過亢進処理装置は、第１位置決め部および第２位置決め部によって当接部に対して位置決めされた状態で当接部を位置基準として皮膚透過亢進処理を行うことにより、組織液抽出部位を形成するように構成されている。このように構成すれば、被験者は第１位置決め部および第２位置決め部によって皮膚透過亢進処理装置を当接部に対して所定の位置に位置決めすることができるので、確実に、当接部に対して同じ位置に組織液抽出部位を形成することができる。   In the tissue fluid collection device according to the second aspect, preferably, 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 portion and performs skin permeation enhancement processing using the contact portion as a position reference while being positioned with respect to the contact portion by the first positioning portion and the second positioning portion. Thus, 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.

上記第２の局面による組織液収集装置において、好ましくは、収集部材保持部は、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させることが可能に構成されており、収集部材は、収集部材保持部に接着されることにより収集部材保持部に保持されており、収集部材が組織液抽出部位に付着された場合に、収集部材が組織液抽出部位に接着されるとともに、収集部材保持部が皮膚から離間された場合に、収集部材保持部と収集部材との接着が外れるように構成されている。このように構成すれば、収集部材保持部を皮膚に押し付けてから離間させるという簡単な作業だけで、収集部材を組織液抽出部位に接着させて付着させたまま残すことができる。これにより、組織液を収集する際の被験者の負担をさらに軽減することができる。   In the tissue fluid collection device according to the second aspect, preferably, 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. When the collecting 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. With this configuration, 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.

この場合、好ましくは、収集部材は、組織液を収集して保持する収集体と、収集体を保持するとともに、皮膚と接着される第１接着部と、収集部材保持部と接着される第２接着部とを有する収集体保持部とを含み、第１接着部の皮膚に対する接着力は、第２接着部の収集部材保持部に対する接着力よりも大きい。このように構成すれば、収集部材保持部を皮膚に押し付けてから離間させた場合に、第１接着部の接着力が第２接着部の接着力よりも大きいので、収集部材を皮膚（組織液抽出部位）に接着させたまま残すことができる。   In this case, preferably, 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. And 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. According to this structure, when the collecting member holding part is pressed against the skin and then separated, the adhesive force of the first adhesive part is larger than the adhesive force of the second adhesive part. Can be left adhered to the part).

上記第１接着部の接着力が第２接着部の接着力よりも大きい構成において、好ましくは、収集体保持部の第１接着部と皮膚との接着面積は、収集体保持部の第２接着部と収集部材保持部との接着面積よりも大きい。このように構成すれば、容易に第１接着部の皮膚に対する接着力を第２接着部の収集部材保持部に対する接着力よりも大きくすることができる。   In the configuration in which the adhesive force of the first adhesive part is larger than the adhesive force of the second adhesive part, preferably, 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.

上記収集部材が、収集体と、第１接着部と第２接着部とを有する収集体保持部とを含む構成において、好ましくは、収集体保持部は、フィルム状に形成されている。このように構成すれば、収集体保持部が重量および厚みの小さいフィルム状に形成されているので、組織液の収集中に収集体およびフィルム状の収集体保持部が皮膚に付着した状態が継続した場合にも、被験者にかかる負担を軽減することができる。   In the configuration in which the collection member includes a collection body and a collection body holding section having a first bonding section and a second bonding section, the collection body holding section is preferably formed in a film shape. If comprised in this way, since the collection body holding | maintenance part was formed in the film form with small weight and thickness, the state which the collection body and the film-like collection body holding | maintenance part adhered to the skin continued during collection | recovery of a tissue fluid. Even in this case, the burden on the subject can be reduced.

上記収集部材が、収集体と、第１接着部と第２接着部とを有する収集体保持部とを含む構成において、好ましくは、収集体保持部は、不透湿性を有する。このように構成すれば、収集体保持部を水分が通過することを抑制することができるので、組織液の収集中に収集体に保持された水分が収集体保持部を通過して蒸発してしまうことを抑制することができる。   In the configuration in which the collection member includes a collection body and a collection body holding section having a first bonding section and a second bonding section, the collection body holding section preferably has impermeableness. If comprised in this way, since it can suppress that a water | moisture content passes a collection body holding | maintenance part, the water | moisture content hold | maintained at the collection body during the collection | collection of a tissue fluid will pass through a collection body holding | maintenance part and will evaporate. This can be suppressed.

上記収集部材が、収集体と、第１接着部と第２接着部とを有する収集体保持部とを含む構成において、好ましくは、収集体は、ゲル部材からなる。このように構成すれば、ゲル部材を用いて、容易に組織液を収集することができる。   In the configuration in which the collecting member includes a collecting body and a collecting body holding portion having a first bonding portion and a second bonding portion, 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.

上記第２の局面による組織液収集装置において、好ましくは、収集部材保持部と当接部とは、一体的に形成されている。このように構成すれば、部品点数が増加することを抑制することができる。また、被験者が扱う部品の数が増加することを抑制することができるので、使用者が容易に組織液の収集を行うことができる。   In the tissue fluid collection device according to the second aspect, preferably, 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.

この場合、好ましくは、収集部材保持部および当接部と一体的に形成されたヒンジ部をさらに備え、収集部材保持部は、当接部に対して、ヒンジ部が折りたたまれた第１位置と、ヒンジ部が開いた第２位置とに変位可能に構成されており、収集部材保持部が第２位置に位置する状態で、皮膚透過亢進処理装置によって皮膚透過亢進処理が行われることにより組織液抽出部位が形成され、収集部材保持部が第１位置に位置する状態で、収集部材保持部に保持された収集部材が組織液抽出部位に付着するように構成されている。このように構成すれば、被験者は、収集部材保持部を第１位置に位置させた状態で組織液抽出部位を形成し、その後に収集部材保持部を第２位置に位置させることにより、収集部材を組織液抽出部位に付着させることができる。このように、被験者は、簡単な作業で、正確に収集部材を組織液抽出部位に付着させて組織液の収集を行うことができる。   In this case, preferably, 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. If comprised in this way, a test subject will form a tissue fluid extraction site | part in the state which located the collection member holding | maintenance part in the 1st position, and a collection member holding part will be located in the 2nd position after that, It can be attached to the tissue fluid extraction site. Thus, the subject can collect tissue fluid by attaching the collection member to the tissue fluid extraction site accurately by a simple operation.

上記第２の局面による組織液収集装置において、好ましくは、当接部は、皮膚と当接して皮膚と接着される第３接着部を含む。このように構成すれば、第３接着部により当接部を皮膚に固定することができるので、組織液抽出部位を形成する際、および収集部材を組織液抽出部位に付着させる際などの作業中に当接部が皮膚から外れることを抑制することができる。これにより、被験者は、容易かつ確実に収集部材を組織液抽出部位に付着させて組織液の収集を行うことができる。   In the tissue fluid collection device according to the second aspect, preferably, the contact portion includes a third adhesive portion that contacts the skin and adheres to the skin. According to this configuration, 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 | deviates from skin. As a result, the subject can collect the tissue fluid easily and reliably by attaching the collecting member to the tissue fluid extraction site.

この発明の第３の局面による生体内成分測定方法は、上記構成を有する組織液収集装置によって、収集部材を組織液抽出部位に付着させ、当接部および収集部材保持部の少なくともいずれか一方を、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させ、１時間以上にわたって組織液抽出部位に付着された収集部材によって収集された組織液に含まれる成分を測定する。   In the in vivo component measuring method according to the third aspect of the present invention, 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.

この第３の局面による生体内成分測定方法では、上記のように、上記構成を有する組織液収集装置によって、収集部材を組織液抽出部位に付着させることにより、当接部を位置基準として皮膚透過亢進処理を行って組織液抽出部位を形成し、かつ、当接部を位置基準として収集部材を皮膚に付着させることができるので、被験者が組織液抽出部位を目視により確認できない場合であっても、収集部材を確実に組織液抽出部位に付着させることができる。これにより、収集部材が組織液抽出部位から外れた位置に付着した状態で組織液の収集が行われることを防止することができるので、生体内成分の測定結果の信頼性を向上させることができる。また、当接部および収集部材保持部の少なくともいずれか一方を、収集部材を組織液抽出部位に付着させた状態で、皮膚から離間させることによって、収集部材を組織液抽出部位に付着させた後は、組織液の収集中には使用されない当接部および収集部材保持部の少なくともいずれかを皮膚から取り外すことができるので、組織液を収集する際に被験者の皮膚に取り付けられる部材の数および重量などを減らすことができる。これにより、組織液を収集する際の被験者の負担を軽減することができる。   In the in-vivo component measurement method according to the third aspect, as described above, 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. To form 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. As a result, 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. In addition, 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.

上記第３の局面による生体内成分測定方法において、好ましくは、収集部材によって収集された組織液に含まれる成分が、グルコースである。このように構成すれば、容易に、グルコースの測定結果の信頼性を向上させるとともに、グルコースを含む組織液を収集する際の被験者の負担を軽減することができる。   In the in vivo component measurement method according to the third aspect, preferably, 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.

本発明の第１実施形態による生体内成分測定システムの全体構成を示す斜視図である。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. 本発明の第１実施形態による生体内成分測定システムの組織液収集装置を示す斜視図である。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. 本発明の第１実施形態による生体内成分測定システムの組織液収集装置を示す上面図である。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. 本発明の第１実施形態による生体内成分測定システムの組織液収集装置を示す下面図である。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. 本発明の第１実施形態による生体内成分測定システムの組織液収集装置を示す側面図である。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. 本発明の第１実施形態による生体内成分測定システムの組織液収集装置を示す図３の１００−１００線に沿った断面図である。It is sectional drawing along the 100-100 line of FIG. 3 which shows the tissue fluid collection device of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの包装状態の組織液収集装置を示す断面図である。It is sectional drawing which shows the tissue fluid collection device of the packaging state of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの収集部材の詳細構造を説明するための断面図である。It is sectional drawing for demonstrating the detailed structure of the collection member of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの測定装置を示す斜視図である。It is a perspective view which shows the measuring apparatus of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの測定装置を示す平面図である。It is a top view which shows the measuring apparatus of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの測定装置を示す側面図である。It is a side view which shows the measuring apparatus of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの微細孔形成装置のスキンガイドを示す斜視図である。It is a perspective view which shows the skin guide of the micropore formation apparatus of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの微細孔形成装置の微細針チップを示す斜視図である。It is a perspective view which shows the microneedle chip | tip of the micropore formation apparatus of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムの微細孔形成装置により形成された微細孔形成領域を示す断面図である。It is sectional drawing which shows the micropore formation area | region formed with the micropore formation apparatus of the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第１実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 1st Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムの組織液収集装置を示す斜視図である。It is a perspective view which shows the tissue fluid collection device of the in-vivo component measuring system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムの組織液収集装置を示す上面図である。It is a top view which shows the tissue fluid collection device of the in-vivo component measurement system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムの組織液収集装置を示す下面図である。It is a bottom view which shows the tissue fluid collection device of the in-vivo component measurement system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムの組織液収集装置を示す側面図である。It is a side view which shows the tissue fluid collection device of the in-vivo component measurement system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムの組織液収集装置を示す図２１の４００−４００線に沿った断面図である。It is sectional drawing along the 400-400 line | wire of FIG. 21 which shows the tissue fluid collection device of the in-vivo component measuring system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 2nd Embodiment of this invention. 本発明の第２実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための断面図である。It is sectional drawing for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measuring system by 2nd Embodiment of this invention. 本発明の第３実施形態による生体内成分測定システムの組織液収集装置を示す斜視図である。It is a perspective view which shows the tissue fluid collection device of the in-vivo component measurement system by 3rd Embodiment of this invention. 本発明の第３実施形態による生体内成分測定システムを用いた生体内成分の測定手順を説明するための平面図である。It is a top view for demonstrating the measurement procedure of the in-vivo component using the in-vivo component measurement system by 3rd Embodiment of this invention. 本発明の第３実施形態の変形例による生体内成分測定システムの組織液収集装置を示す斜視図である。It is a perspective view which shows the tissue fluid collection device of the in-vivo component measuring system by the modification of 3rd Embodiment of this invention. 本発明の第１実施形態の変形例による生体内成分測定システムの組織液収集装置を示す斜視図である。It is a perspective view which shows the tissue fluid collection device of the in-vivo component measuring system by the modification of 1st Embodiment of this invention.

以下、本発明を具体化した実施形態を図面に基づいて説明する。   DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments embodying the present invention will be described below with reference to the drawings.

（第１実施形態）
まず、図１〜図１４を参照して、本発明の第１実施形態による生体内成分測定システム１の全体構成について説明する。(First embodiment)
First, with reference to FIGS. 1-14, the whole structure of the in-vivo component measuring system 1 by 1st Embodiment of this invention is demonstrated.

図１に示すように、第１実施形態による生体内成分測定システム１は、被験者の皮膚６（図１４参照）の微細孔６ａが形成された領域（微細孔形成領域６ｂ）から出る組織液を収集するための組織液収集装置２と、組織液収集装置２によって収集された組織液内の所定の成分（第１実施形態では、グルコース）の量を測定するための測定装置３と、被験者の皮膚６に微細孔６ａを形成する微細孔形成装置４とを備えている。   As shown in FIG. 1, the in-vivo component measurement system 1 according to the first embodiment 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. And a fine hole forming device 4 for forming the holes 6a.

図１〜図７に示すように、組織液収集装置２は、組織液を収集するための収集部材２１と、収集部材２１を保持する本体２２とを含んでいる。組織液収集装置２は、包装部材２３（図７参照）に包装された状態で保管されており、組織液の収集を行う際に包装部材２３から取り出して使用される。   As shown in FIGS. 1 to 7, the tissue fluid collection device 2 includes a collection member 21 for collecting tissue fluid and a main body 22 that holds the collection 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.

収集部材２１は、被験者の皮膚６から抽出した組織液を保持可能な吸湿性を有するポリビニルアルコールからなるゲル部材２４と、ゲル部材２４を保持するゲル保持部材２５とから構成されている。図８に示すように、ゲル保持部材２５は、小さい厚みＴ１（たとえば、約７０μｍ）を有するとともに伸縮性を有するフィルム状のドレッシングテープ２５ａと、ドレッシングテープ２５ａを支持する枠状のフレーム部材２５ｂとからなる。ドレッシングテープ２５ａは、不透湿性を有する。フレーム部材２５ｂは、ドレッシングテープ２５ａよりも硬く、変形しにくいように構成されている。フレーム部材２５ｂは、たとえば、ドレッシングテープ２５ａの厚みＴ１よりも大きい厚みＴ２を有するＰＥＴ樹脂からなる。また、ゲル部材２４は、ドレッシングテープ２５ａの中央部に接着されることにより保持されている。   The collecting member 21 includes 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. As shown in FIG. 8, the gel holding member 25 includes a film-shaped dressing tape 25a having a small thickness T1 (for example, about 70 μm) 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. Moreover, the gel member 24 is hold | maintained by adhere | attaching on the center part of the dressing tape 25a.

ドレッシングテープ２５ａおよびフレーム部材２５ｂからなるゲル保持部材２５の皮膚当接側の面（図１〜図６では露出している側の面、図４では露出している側の面の背面）は全面的に粘着性を有しており、接着部２１ａを構成している。収集部材２１の皮膚非当接側の面（図１〜図６では露出している側の面、図４では露出している側の面の背面）は、部分的に粘着性を有しており、接着部２１ｂ（図１および図４参照）を構成している。これにより、収集部材２１を皮膚６に接着した場合に、接着部２１ａの皮膚６に対する接着面積は、接着部２１ｂの本体２２（後述する収集部材保持部２７）に対する接着面積よりも大きくなるように構成されている。すなわち、接着部２１ａの皮膚６に対する接着力は、接着部２１ｂの収集部材保持部２７に対する接着力よりも大きい。   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). Thereby, when the collecting member 21 is bonded to the skin 6, 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.

本体２２は、皮膚６と当接して微細孔形成装置４の穿刺位置およびゲル部材２４の付着位置の位置基準として機能する当接部２６と、収集部材２１を保持する収集部材保持部２７と、当接部２６に対して収集部材保持部２７を回動させるヒンジ部２８とを含んでいる。当接部２６、収集部材保持部２７およびヒンジ部２８は、樹脂成形により一体的に形成されている。   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.

当接部２６は、中央部に収集部材保持部２７よりも大きい開口部２６ａを有する枠形状に形成されている。当接部２６の皮膚当接側の面（図１〜図６では、下面）は、粘着性を有しており、接着部２６ｂを構成している。この接着部２６ｂにより、本体２２を被験者の皮膚６に固定することが可能である。枠形状の当接部２６の皮膚非当接側の面（図１〜図６では、上面）には、後述する微細孔形成装置４と係合する凹形状の係合部２６ｃが互いに対向する２辺に一対形成されている。   The contact portion 26 is formed in a frame shape having an opening 26 a larger than the collection member holding portion 27 at the center. 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 micropore forming device 4 described later face each other on the non-skin contact surface (upper surface in FIGS. 1 to 6) of the frame-shaped contact portion 26. A pair is formed on two sides.

収集部材保持部２７は平板状に形成されており、収集部材保持部２７の皮膚当接側の面２７ａと、収集部材２１の皮膚非当接側の面（接着部２１ｂ）とが接着されることにより、収集部材保持部２７が収集部材２１を保持している。収集部材保持部２７は、当接部２６に対して、ヒンジ部２８が折りたたまれた第１位置Ｐ（図７参照）と、ヒンジ部２８が開いた第２位置Ｑ（図６参照）とに変位可能に構成されている。図７に示すように、第１位置Ｐにおいては、収集部材保持部２７が当接部２６の開口部２６ａ内に配置されるとともに、収集部材保持部２７に保持された収集部材２１のゲル部材２４が開口部２６ａの中心位置に位置するように構成されている。   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.

図７に示すように、組織液収集装置２（収集部材２１および本体２２）が包装部材２３に包装されている状態においては、収集部材２１が収集部材保持部２７の皮膚当接側の面と接着部２１ｂ（図１および図４参照）により接着されており、かつ、収集部材２１の皮膚当接部側の面（接着部２１ａ）およびゲル部材２４が剥離シート２９ａにより覆われている。ゲル部材２４が剥離シート２９ａにより覆われていることにより、ゲル部材２４と包装部材２３とが直接接触することを防止している。また、当接部２６の皮膚当接側の面（接着部２６ｂ）も剥離シート２９ｂにより覆われている。   As shown in FIG. 7, in a state where the tissue fluid collection device 2 (collection member 21 and main body 22) is packaged in the packaging member 23, 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.

図９〜図１１に示すように、測定装置３は、表示部３１と、記録部３２と、解析部３３と、電源３４と、センサチップ２００および収集部材２１を設置するための設置部３５と、設置部３５に設置されたセンサチップ２００に接続される電気回路３６と、ユーザ（被験者）が測定装置３を操作するための操作ボタン３７と、タイマー部３８とを備えている。   As shown in FIGS. 9 to 11, the measuring device 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 collection 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.

表示部３１は、解析部３３による測定結果および記録部３２に記録されたデータなどを表示する機能を有する。記録部３２は、過去のデータを保存するために設けられている。解析部３３は、電気回路３６の出力値に基づいて、グルコース濃度および電解質（ＮａＣｌ）濃度を算出する機能を有する。設置部３５は、凹形状を有しており、センサチップ２００および収集部材２１を設置することが可能に構成されている。電気回路３６は、グルコース測定用回路３６ａと、電解質測定用回路３６ｂとを含んでいる。グルコース測定用回路３６ａは、設置部３５内に露出した端子３６ｃおよび３６ｄを含んでおり、電解質測定用回路３６ｂは、設置部３５内に露出した端子３６ｅおよび３６ｆを含んでいる。また、電気回路３６は、グルコース測定用回路３６ａと、電解質測定用回路３６ｂとを切り替えるためのスイッチ３６ｇを含んでいる。ユーザは、操作ボタン３７を操作することによりスイッチ３６ｇを操作して、グルコース測定用回路３６ａと、電解質測定用回路３６ｂとを切り替えることが可能である。操作ボタン３７は、スイッチ３６ｇの切換、表示部３１の表示の切換およびタイマー部３８の設定などの操作をするために設けられている。タイマー部３８は、グルコースの収集を開始してから所定の時間で収集を終了するために、ユーザに抽出の終了時間を通知する機能を有する。   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, and 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.

センサチップ２００は、プラスチック製の基板２０１と、基板２０１の上面上に設けられた一対のグルコース測定用電極２０２と、基板２０１の上面上に設けられた一対の電解質測定用電極２０３とを含んでいる。グルコース測定用電極２０２は、白金電極にＧＯＤ酵素膜（ＧＯＤ：グルコースオキシダーゼ）が形成された作用電極２０２ａと白金電極からなる対電極２０２ｂとからなり、電解質測定用電極２０３は、銀／塩化銀からなる作用電極２０３ａと銀／塩化銀からなる対電極２０３ｂとからなる。センサチップ２００が測定装置３の設置部３５に設置された状態で、グルコース測定用電極２０２の作用電極２０２ａおよび対電極２０２ｂは、それぞれ、グルコース測定用回路３６ａの端子３６ｃおよび３６ｄと接触するように構成されている。同様に、センサチップ２００が測定装置３の設置部３５に設置された状態で、電解質測定用電極２０３の作用電極２０３ａおよび対電極２０３ｂは、それぞれ、電解質測定用回路３６ｂの端子３６ｅおよび３６ｆと接触するように構成されている。   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. Yes. 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. In a state where the sensor chip 200 is installed on the installation unit 35 of the measuring device 3, 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. Similarly, 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.

図１および図１２〜図１４に示すように、微細孔形成装置４は、減菌処理された微細針チップ５を装着して、その微細針チップ５の微細針５ａを生体の表皮（被験者の皮膚６）に当接させることによって、被験者の皮膚６に組織液の抽出孔（微細孔６ａ）を形成する装置である。以後、微細孔６ａが形成された領域を微細孔形成領域６ｂと呼ぶ。微細針チップ５の微細針５ａは、微細孔形成装置４により微細孔６ａを形成した場合に、その微細孔６ａが皮膚６の角質層を貫通するとともに表皮内部と真皮との境界まで到達するが、真皮の深部までは到達しないような大きさを有する。図１に示すように、微細孔形成装置４は、筐体４ａと、筐体４ａの表面に設けられたリリースボタン４ｂと、筐体４ａの内部に設けられたアレイチャック４ｃおよびバネ部材４ｄとを備えている。バネ部材４ｄはアレイチャック４ｃを下方に付勢する機能を有する。アレイチャック４ｃは下端に微細針チップ５を装着することが可能である。微細針チップ５の下面には、複数の微細針５ａが形成されている。また、微細孔形成装置４は、アレイチャック４ｃをバネ部材４ｄの付勢力に逆らって上方に押し上げた状態で固定する固定機構（図示せず）を有しており、使用者（被験者）がリリースボタン４ｂを押下することにより、固定機構によるアレイチャック４ｃの固定が解除されるように構成されている。   As shown in FIG. 1 and FIGS. 12 to 14, the micropore forming device 4 is equipped with a microneedle chip 5 that has been sterilized, and the microneedle 5 a 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). Hereinafter, the region in which the micro holes 6a are formed is referred to as a micro hole forming region 6b. When the micropore 5a of the microneedle chip 5 is formed by the micropore forming device 4, the micropore 6a penetrates the stratum corneum of the skin 6 and reaches the boundary between the inside of the epidermis and the dermis. It has a size that does not reach the deep part of the dermis. As shown in FIG. 1, 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. A plurality of fine needles 5 a are formed on the lower surface of the fine needle chip 5. 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.

また、第１実施形態では、図１および図１２に示すように、微細孔形成装置４の下部に取り付けられたスキンガイド４ｅの下面には、下方に突出するように周状に形成されたリブ４ｆが設けられている。このリブ４ｆの形状は、組織液収集装置２の当接部２６の皮膚非当接側の面に設けられた凹形状の一対の係合部２６ｃの形状と合致するように形成されている。すなわち、スキンガイド４ｅの周状のリブ４ｆを一対の当接部２６の係合部２６ｃに係合させることにより、当接部２６に対してスキンガイド４ｅ（微細孔形成装置４）を位置決めすることが可能である。当接部２６を皮膚６に当接させた状態で、リブ４ｆと係合部２６ｃとを係合させて位置決めした状態で穿刺を行った場合、微細孔形成領域６ｂは、当接部２６の開口部２６ａの中央位置に形成されるように構成されている。   Further, in the first embodiment, as shown in FIGS. 1 and 12, 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. When puncture is performed in a state where the rib 4f and the engaging portion 26c are engaged and positioned while the contact portion 26 is in contact with the skin 6, the fine hole forming region 6b It is configured to be formed at the center position of the opening 26a.

次に、図１、図４、図７、図９〜図１１および図１５〜図１９を参照して、本発明の第１実施形態による生体内成分測定システム１による測定手順について説明する。   Next, a measurement procedure by the in-vivo component measurement system 1 according to the first embodiment of the present invention will be described with reference to FIGS. 1, 4, 7, 9, 11 and 15 to 19. FIG.

まず、被験者は、包装部材２３（図７参照）から組織液収集装置２を取り出す。そして、図１５に示すように、剥離シート２９ｂを剥がすことにより接着部２６ｂを露出させた状態で、組織液収集装置２の本体２２の当接部２６を皮膚６に付着させる。この時、組織液を抽出しようとする部位を当接部２６の開口部２６ａの中央に配置するように本体２２を配置させて付着させる。また、被験者は、剥離シート２９ａを剥がすことにより、ゲル部材２４および収集部材２１の接着部２１ａを露出させる。   First, 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 collecting device 2 is attached to the skin 6 in a state where the adhesive portion 26 b is exposed by peeling the release sheet 29 b. At this time, the main body 22 is arranged and attached so that the site from which the tissue fluid is to be extracted is arranged at the center of the opening 26 a of the contact portion 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.

次に、図１６に示すように、被験者は、ヒンジ部２８を開くことにより収集部材保持部２７を回動させて第２位置Ｑに位置させた状態で、微細孔形成装置４のリブ４ｆを当接部２６の凹形状の係合部２６ｃに係合させる。これにより、微細孔形成装置４が当接部２６に対して位置決めされる。そして、リリースボタン４ｂを押すことによって、固定機構（図示せず）によるアレイチャック４ｃの固定を解除する。これにより、微細針チップ５が皮膚６に衝突されて皮膚６に微細孔形成領域６ｂが形成される。この微細孔形成領域６ｂは、当接部２６の開口部２６ａの中央位置に形成される。この後、被験者は、微細孔形成装置４および微細針チップ５を皮膚６から取り外す。   Next, as shown in FIG. 16, 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. Thereby, the fine hole forming device 4 is positioned with respect to the contact portion 26. Then, pressing the release button 4b releases the fixation of the array chuck 4c by a fixing mechanism (not shown). As a result, 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. Thereafter, the subject removes the fine hole forming device 4 and the fine needle tip 5 from the skin 6.

次に、図１７に示すように、被験者は、ヒンジ部２８を折りたたむことにより収集部材保持部２７を回動させて第１位置Ｐに位置させる。これにより、収集部材保持部２７に保持された収集部材２１のゲル部材２４が微細孔形成領域６ｂ上に配置される。なお、上記した説明では、穿刺を行う前に剥離シート２９ａを剥がしたが、穿刺後に剥離シート２９ａを剥がしてもよい。   Next, as illustrated in FIG. 17, the subject rotates the collection member holding portion 27 by folding the hinge portion 28 to the first position P. As a result, 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. In the above description, the release sheet 29a is peeled off before puncturing, but the release sheet 29a may be peeled off after puncturing.

そして、被験者が収集部材保持部２７をさらに皮膚６側に押圧すると、図１８に示すように、ゲル部材２４が微細孔形成領域６ｂ上に配置された状態で、収集部材２１の接着部２１ａがゲル部材２４の周囲の領域（フレーム部材２５ｂの部分など）において皮膚６に接着される。この時、厚みの大きいゲル部材２４が伸縮性を有するドレッシングテープ２５ａに保持されているので、ゲル保持部材２５の縁部が皮膚６に接着された状態でゲル部材２４の厚み分だけゲル保持部材２５の中央部（ドレッシングテープ２５ａの部分）の高さが盛り上がった場合にも、ドレッシングテープ２５ａが伸びることにより、ゲル部材２４を無理なく保持することが可能である。   When the subject presses the collection member holding portion 27 further toward the skin 6 side, as shown in FIG. 18, 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 an area around the gel member 24 (such as the frame member 25b). At this time, since the thick gel member 24 is held by the stretchable dressing tape 25a, 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.

この後、図１９に示すように、被験者は、組織液の収集中には使用されない本体２２を皮膚６から離間させて取り除く。収集部材２１は収集部材保持部２７の面２７ａに接着部２１ｂ（図１および図４参照）の接着力により接着されているが、接着部２１ｂの収集部材保持部２７に対する接着力が接着部２１ａの皮膚６に対する接着力よりも小さい。このため、本体２２を皮膚６から離間させるように本体２２に力が加わった場合、収集部材２１が皮膚６に付着したまま、収集部材２１と収集部材保持部２７の面２７ａとの接着が外れる。これにより、組織液の収集に最低限必要な収集部材２１を皮膚６に付着させたまま、組織液の収集に必要のない本体２２を取り除くことが可能である。   Thereafter, as shown in FIG. 19, 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.

次に、ゲル部材２４が正確に微細孔形成領域６ｂに配置された状態で、被験者は、所定の時間（約１〜３時間）だけ放置する。この間に、微細孔形成領域６ｂから抽出された組織液がゲル部材２４に収集される。そして、所定の時間が経過した後、被験者は、収集部材２１を皮膚６から取り外す。   Next, the test subject is left for a predetermined time (about 1 to 3 hours) in a state where the gel member 24 is accurately disposed 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.

そして、被験者は、測定装置３を用いて所定の時間にわたって収集部材２１に収集された生体内成分の測定（グルコース濃度の測定）を行う。   Then, 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).

具体的には、図９〜図１１に示すように、被験者は、測定装置３の設置部３５にセンサチップ２００を設置するとともに、センサチップ２００の上に抽出終了後の収集部材２１を設置する。これにより、測定装置３のグルコース測定用回路３６ａ、センサチップ２００のグルコース測定用電極２０２および収集部材２１のゲル部材２４によって第１回路が構成されるとともに、測定装置３の電解質測定用回路３６ｂ、センサチップ２００の電解質測定用電極２０３および収集部材２１のゲル部材２４によって第２回路が構成される。   Specifically, as shown in FIGS. 9 to 11, the subject installs the sensor chip 200 on the installation unit 35 of the measuring device 3 and installs the collection member 21 after extraction on the sensor chip 200. . As a result, 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, and the electrolyte measuring circuit 36b of the measuring device 3; The electrolyte measurement electrode 203 of the sensor chip 200 and the gel member 24 of the collection member 21 constitute a second circuit.

抽出したグルコース濃度を測定する場合には、被験者は、操作ボタン３７によりスイッチ３６ｇをグルコース測定用回路３６ａに切り替えるとともに、測定開始を指示する。これにより、所定の値の一定電圧が第１回路に印加され、電流計により検出された電流値が解析部３３に入力される。解析部３３には、電流値とグルコース濃度との関係に基づく関数が記憶されている。解析部３３は、記憶されている関数と入力された電流値とに基づいて、ゲル部材２４内のグルコース濃度を算出する。   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.

さらに、第１実施形態においては、測定装置３によってゲル部材２４に含まれる電解質濃度を測定することができる。この場合、被験者は、操作ボタン３７によりスイッチ３６ｇを電解質測定用回路３６ｂに切り替えるとともに、測定開始を指示する。これにより、第２回路に発生する電解質由来の起電力を電圧計により検出し、電圧計により検出された電圧値が解析部３３に入力される。検出される電圧値は、グルコース濃度と同様に、ゲル部材２４に含まれる電解質濃度に比例する。そこで、解析部３３には、電圧値と電解質濃度との関係に基づく関数が記憶されており、解析部３３は、記憶されている関数と入力された電圧値とに基づいて、ゲル部材２４内の電解質濃度を算出する。   Furthermore, in the first embodiment, the electrolyte concentration contained in the gel member 24 can be measured by the measuring device 3. In this case, the test subject switches the switch 36g to the electrolyte measurement circuit 36b by the operation button 37 and instructs the start of measurement. Thereby, 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.

第１実施形態では、上記のように、予め当接部２６が皮膚６に当接された状態で、当接部２６を位置基準として微細孔形成装置４により微細孔形成領域６ｂを形成するとともに、皮膚６に当接された当接部２６を位置基準として、収集部材２１を微細孔形成領域６ｂに付着させることが可能に構成された収集部材保持部２７とを設けている。このように構成することによって、当接部２６を位置基準として微細孔形成領域６ｂを形成し、かつ、当接部２６を位置基準として収集部材２１を微細孔形成領域６ｂに付着させることができるので、被験者が微細孔形成領域６ｂを目視により確認できない場合であっても、収集部材２１を確実に微細孔形成領域６ｂに付着させることができる。これにより、収集部材２１が微細孔形成領域６ｂから外れた位置に付着した状態で組織液の収集が行われることを防止することができるので、生体内成分の測定結果の信頼性を向上させることができる。また、当接部２６および収集部材保持部２７の両方を、収集部材２１を微細孔形成領域６ｂに付着させた状態で、皮膚６から離間させることが可能に構成することによって、収集部材２１を微細孔形成領域６ｂに付着させた後は、組織液の収集中は使用されない当接部２６および収集部材保持部２７の少なくともいずれかを皮膚６から取り外すことができるので、組織液を収集する際に被験者の皮膚６に取り付けられる部材の数および重量などを減らすことができる。これにより、組織液を収集する際に被験者の皮膚６に取り付けられる部材の数および重量などを最小限にすることができるので、組織液を収集する際の被験者の負担を軽減することができる。   In the first embodiment, as described above, 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. By configuring in this way, the fine hole forming region 6b can be formed using the contact portion 26 as a position reference, and the collecting member 21 can be attached to the fine hole forming region 6b using the contact portion 26 as a position reference. Therefore, even if a test subject cannot confirm the micropore formation area | region 6b visually, the collection member 21 can be made to adhere to the micropore formation area | region 6b reliably. As a result, it is possible to prevent the collection of the tissue fluid in a state where the collection member 21 is attached at a position off the micropore formation region 6b, so that the reliability of the measurement result of the in vivo component can be improved. it can. Further, by configuring both the abutting portion 26 and the collecting member holding portion 27 so as to be separated from the skin 6 in a state where the collecting member 21 is attached to the micropore forming region 6b, the collecting member 21 can be separated. After adhering to the micropore formation region 6b, 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.

また、第１実施形態では、上記のように、微細孔形成装置４のリブ４ｆと当接部２６の凹形状の係合部２６ｃとを係合した状態で微細孔形成領域６ｂを形成するように構成している。このように構成することによって、被験者は微細孔形成装置４のリブ４ｆと当接部２６の凹形状の係合部２６ｃとを係合させることによって微細孔形成装置４を当接部２６に対して所定の位置に位置決めすることができるので、容易かつ確実に、当接部２６に対して同じ位置（開口部２６ａの中心位置）に微細孔形成領域６ｂを形成することができる。   In the first embodiment, as described above, 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.

また、第１実施形態では、上記のように、収集部材２１が微細孔形成領域６ｂに付着された場合に、収集部材２１が微細孔形成領域６ｂに接着されるとともに、収集部材保持部２７が皮膚６から離間された場合に、収集部材保持部２７と収集部材２１との接着が外れるように構成している。このように構成することによって、収集部材保持部２７を皮膚６に押し付けてから離間させるという簡単な作業だけで、収集部材２１を微細孔形成領域６ｂに接着させて付着させたまま残すことができる。これにより、組織液を収集する際の被験者の負担をさらに軽減することができる。   In the first embodiment, as described above, 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.

また、第１実施形態では、上記のように、収集部材２１の接着部２１ａの皮膚６に対する接着力を、収集部材２１の接着部２１ｂの収集部材保持部２７に対する接着力よりも大きくしている。このように構成することによって、収集部材保持部２７を皮膚６に押し付けてから離間させた場合に、接着部２１ａの接着力が接着部２１ｂの接着力よりも大きいので、収集部材２１を皮膚６（微細孔形成領域６ｂ）に接着させたまま残すことができる。   Moreover, in 1st Embodiment, as mentioned above, 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 | maintenance part 27 of the adhesion part 21b of the collection member 21. . With this configuration, when the collecting member holding portion 27 is pressed against the skin 6 and then separated, 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).

また、第１実施形態では、上記のように、収集部材２１の接着部２１ａと皮膚６との接着面積が、収集部材２１の接着部２１ｂと収集部材保持部２７との接着面積よりも大きくなるように構成することによって、容易に接着部２１ａの皮膚６に対する接着力を接着部２１ｂの収集部材保持部２７に対する接着力よりも大きくすることができる。   In the first embodiment, as described above, 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. With this configuration, the adhesive force of the adhesive portion 21a to the skin 6 can be easily made larger than the adhesive force of the adhesive portion 21b to the collecting member holding portion 27.

また、第１実施形態では、上記のように、ゲル保持部材２５をフィルム状に形成することによって、ゲル保持部材２５が重量および厚みの小さいフィルム状に形成されているので、組織液の収集中にゲル部材２４およびフィルム状のゲル保持部材２５が皮膚６に付着した状態が継続した場合にも、被験者にかかる負担を軽減することができる。   In the first embodiment, as described above, 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.

また、第１実施形態では、上記のように、ゲル保持部材２５を不透湿性を有する部材から構成することによって、ゲル保持部材２５を水分が通過することを抑制することができるので、組織液の収集中にゲル部材２４に保持された水分がゲル保持部材２５を通過して蒸発してしまうことを抑制することができる。   Moreover, in 1st Embodiment, since it can suppress that a water | moisture content passes the gel holding member 25 by comprising the gel holding member 25 from the member which has a moisture-impervious property as mentioned above, a tissue fluid It can suppress that the water | moisture content hold | maintained at the gel member 24 during collection passes the gel holding member 25 and evaporates.

また、第１実施形態では、上記のように、収集部材保持部２７と当接部２６とを一体的に形成することによって、部品点数が増加することを抑制することができる。また、被験者が扱う部品の数が増加することを抑制することができるので、使用者が容易に組織液の収集を行うことができる。   Moreover, in 1st Embodiment, as mentioned above, it can suppress that a number of parts increases by forming the collection member holding | maintenance part 27 and the contact part 26 integrally. 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.

また、第１実施形態では、上記のように、収集部材保持部２７を、当接部２６に対して、ヒンジ部２８が折りたたまれた第１位置Ｐと、ヒンジ部２８が開いた第２位置Ｑとに変位可能に構成するとともに、収集部材保持部２７が第２位置Ｑに位置する状態で、微細孔形成装置４によって微細孔形成領域６ｂを形成し、収集部材保持部２７が第１位置Ｐに位置する状態で、収集部材保持部２７に保持された収集部材２１を微細孔形成領域６ｂに付着させるように構成している。このように構成することによって、被験者は、収集部材保持部２７を第１位置Ｐに位置させた状態で微細孔形成領域６ｂを形成し、その後に収集部材保持部２７を第２位置Ｑに位置させることにより、収集部材２１のゲル部材２４を微細孔形成領域６ｂに付着させることができる。このように、被験者は、簡単な作業で、正確に収集部材２１のゲル部材２４を微細孔形成領域６ｂに付着させて組織液の収集を行うことができる。   In the first embodiment, as described above, 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. By configuring in this way, 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. By doing so, the gel member 24 of the collecting member 21 can be attached to the micropore forming region 6b. Thus, 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.

また、第１実施形態では、上記のように、微細孔形成装置４によって皮膚６に形成された微細孔形成領域６ｂから出る組織液を収集することによって、微細孔６ａを介して組織液が皮膚６から出やすくなるので、容易にゲル部材２４に組織液を収集することができる。   In the first embodiment, as described above, 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.

また、第１実施形態では、上記のように、皮膚６と当接して皮膚６と接着される接着部２６ｂを当接部２６に設けることによって、接着部２６ｂにより当接部２６を皮膚６に固定することができるので、微細孔形成領域６ｂを形成する際、および収集部材２１を微細孔形成領域６ｂに付着させる際などの作業中に当接部２６が皮膚６から外れることを抑制することができる。これにより、被験者は、容易かつ確実に収集部材２１を微細孔形成領域６ｂに付着させて組織液の収集を行うことができる。   In the first embodiment, as described above, 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.

（第２実施形態）
次に、図７および図２０〜図２４を参照して、本発明の第２実施形態による生体内成分測定システムについて説明する。この第２実施形態では、収集部材２１をゲル保持部材２５からなる１層構造とした上記第１実施形態と異なり、収集部材３０１をゲル保持部材３０２とゲル保持部材３０２を皮膚６に直接接触させないためのシート部材３０３との２層構造とした例について説明する。(Second Embodiment)
Next, with reference to FIG. 7 and FIGS. 20 to 24, the in-vivo component measurement system according to the second embodiment of the present invention will be described. In the second embodiment, unlike the first embodiment in which the collecting member 21 has a one-layer structure composed of the gel holding member 25, the collecting member 301 is not brought into direct contact with the skin 6 and the gel holding member 302 and the gel holding member 302. An example of a two-layer structure with a sheet member 303 for this purpose will be described.

図２０〜図２４に示すように、第２実施形態による生体内成分測定システムの組織液収集装置３００では、収集部材３０１は、ゲル部材２４と、ゲル部材２４を保持するアルミフィルムからなるゲル保持部材３０２と、ゲル保持部材３０２を皮膚６に直接接触させないためのシート部材３０３とから構成されている。   As shown in FIGS. 20 to 24, in the tissue fluid collection device 300 of the in vivo component measurement system according to the second embodiment, the collection member 301 is a gel holding member made of a gel member 24 and an aluminum film holding the gel member 24. 302 and a sheet member 303 for preventing the gel holding member 302 from directly contacting the skin 6.

ゲル保持部材３０２の皮膚非当接側の面の一部が粘着性を有しており、接着部３０２ａを構成している。ゲル保持部材３０２は、接着部３０２ａの接着力によって収集部材保持部２７の面２７ａに接着されている。シート部材３０３の中央部には、開口部３０３ａが設けられており、ゲル部材２４は、開口部３０３ａを介してシート部材３０３の皮膚当接側の面側に突出している。シート部材３０３の皮膚非当接側（ゲル保持部材３０２側）の面は全面が粘着性を有しており、接着部３０３ｂを構成している。シート部材３０３は、接着部３０３ｂの接着力によってゲル保持部材３０２に接着されている。また、シート部材３０３の皮膚当接側の面は全面が粘着性を有しており、接着部３０３ｃを構成している。シート部材３０３は、接着部３０３ｃの接着力によって皮膚６に付着することが可能である。   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.

組織液収集装置３００が包装部材２３（図７参照）に包装されている状態においては、シート部材３０３の接着部３０３ｃおよびゲル部材２４を覆うように、剥離シート２９ａが接着部３０３ｃに接着されている。シート部材３０３の接着部３０３ｃの皮膚６に対する接着力およびシート部材３０３のゲル保持部材３０２に対する接着力は、ゲル保持部材３０２の接着部３０２ａの収集部材保持部２７に対する接着力よりも大きい。   In a state where the tissue fluid collecting device 300 is packaged in the packaging member 23 (see FIG. 7), 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.

第２実施形態の上記した構造以外の構造は、上記第１実施形態と同様である。   Structures other than the above-described structure of the second embodiment are the same as those of the first embodiment.

次に、図７、図２０および図２５〜図２９を参照して、本発明の第２実施形態による生体内成分測定システムによる測定手順について説明する。   Next, with reference to FIG. 7, FIG. 20 and FIGS. 25-29, the measurement procedure by the in-vivo component measurement system by 2nd Embodiment of this invention is demonstrated.

まず、被験者は、包装部材２３（図７参照）から組織液収集装置３００を取り出す。そして、図２５に示すように、剥離シート２９ｂ（図２０参照）を剥がすことにより接着部２６ｂを露出させた状態で、組織液収集装置３００の本体２２の当接部２６を皮膚６に付着させる。また、被験者は、剥離シート２９ａを剥がすことにより、ゲル部材２４およびシート部材３０３の接着部３０３ｃを露出させる。   First, 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.

次に、図２６に示すように、被験者は、微細孔形成装置４のリブ４ｆと当接部２６の係合部２６ｃとを係合させて微細孔形成装置４を当接部２６に対して位置決めした状態で、微細孔形成装置４により穿刺を行う。これにより、微細孔形成領域６ｂが、当接部２６の開口部２６ａの中央位置に形成される。この後、被験者は、微細孔形成装置４および微細針チップ５を皮膚６から取り外す。   Next, as shown in FIG. 26, 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. In the positioned state, puncture is performed by the micropore forming device 4. Thereby, the fine hole forming region 6 b is formed at the center position of the opening 26 a of the contact portion 26. Thereafter, the subject removes the fine hole forming device 4 and the fine needle tip 5 from the skin 6.

次に、図２７に示すように、被験者は、ヒンジ部２８を閉じることにより収集部材保持部２７を回動させて第２位置Ｑから第１位置Ｐに位置させる。これにより、収集部材保持部２７に保持され、シート部材３０３の開口部３０３ａを介してシート部材３０３よりも皮膚６側に突出しているゲル部材２４が微細孔形成領域６ｂ上に配置される。   Next, as shown in FIG. 27, 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. As a result, 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.

そして、被験者が収集部材保持部２７をさらに皮膚６側に押圧すると、ゲル部材２４が微細孔形成領域６ｂ上に配置された状態で、シート部材３０３の接着部３０３ｃが皮膚６に接着される。   When the subject presses the collection member holding portion 27 further toward the skin 6, the adhesive portion 303 c 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 6 b.

この後、図２８に示すように、被験者は、組織液の収集中は使用されない本体２２を皮膚６から離間させて取り除く。収集部材３０１は収集部材保持部２７にゲル保持部材３０２の接着部３０２ａの接着力により接着されているが、接着部３０２ａの収集部材保持部２７に対する接着力が、シート部材３０３の接着部３０３ｃの皮膚６に対する接着力およびシート部材３０３の接着部３０３ｂのゲル保持部材３０２に対する接着力よりも小さい。このため、本体２２を皮膚６から離間させた場合、ゲル保持部材３０２がシート部材３０３に接着され、かつ、シート部材３０３が皮膚６に付着した状態で、収集部材３０１と収集部材保持部２７との接着（接着部３０２ａによる接着）が外れる。これにより、収集部材３０１を皮膚６に付着させたまま、組織液の収集に必要のない本体２２を取り除くことが可能である。   Thereafter, as shown in FIG. 28, the subject removes the body 22 that is not used during the collection of the tissue fluid away 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. However, 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. Therefore, when the main body 22 is separated from the skin 6, 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.

次に、図２９に示すように、微細孔形成領域６ｂから抽出された組織液を所定の時間にわたってゲル部材２４に収集した後、被験者は、収集部材３０１のうち、ゲル部材２４を保持するゲル保持部材３０２を皮膚６から取り外す。この時、シート部材３０３は皮膚６に付着したままである。   Next, as shown in FIG. 29, after collecting the tissue fluid extracted from the micropore formation region 6 b in the gel member 24 over a predetermined time, the subject holds the gel holding the gel member 24 among the collection members 301. The member 302 is removed from the skin 6. At this time, the sheet member 303 remains attached to the skin 6.

そして、被験者は、測定装置３を用いてゲル部材２４に収集された生体内成分の測定（グルコース濃度の測定）を行う。グルコース濃度の測定は、上記第１実施形態と同様である。なお、ゲル保持部材３０２とシート部材３０３とを一緒に皮膚６から取り外して、その後にシート部材３０３とゲル保持部材３０２とを分離させて測定を行ってもよい。   Then, the subject measures the in-vivo components collected in the gel member 24 using the measuring device 3 (measurement of glucose concentration). The measurement of the glucose concentration is the same as in the first embodiment. Note that 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.

第２実施形態では、上記のように、ゲル保持部材３０２を皮膚６に直接接触させないためのシート部材３０３を設けることによって、ゲル保持部材３０２が皮膚６に直接接着されることに起因してゲル保持部材３０２に皮膚６上の角質などの異物が付着することを抑制することができる。これにより、ゲル部材２４およびゲル保持部材３０２をまとめて測定装置３により測定を行う場合に、ゲル保持部材３０２に付着した異物に起因して測定結果がずれてしまうことを抑制することができる。   In the second embodiment, as described above, 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.

第２実施形態のその他の効果は、上記第１実施形態と同様である。   Other effects of the second embodiment are the same as those of the first embodiment.

（第３実施形態）
次に、図１および図３０および図３１を参照して、本発明の第３実施形態による生体内成分測定システムについて説明する。この第３実施形態では、当接部２６と収集部材保持部２７とが一体的に形成された上記第１実施形態と異なり、当接部（当接部材５０１）と収集部材保持部（収集部材保持部材５０２）とを別体として形成した例について説明する。(Third embodiment)
Next, an in-vivo component measurement system according to a third embodiment of the present invention will be described with reference to FIG. 1, FIG. 30, and FIG. In the third embodiment, unlike the first embodiment in which the contact portion 26 and the collection member holding portion 27 are integrally formed, the contact portion (contact member 501) and the collection member holding portion (collection member) An example in which the holding member 502) is formed separately will be described.

第３実施形態では、図３０に示すように、組織液収集装置５００は、組織液を収集するための収集部材２１と、皮膚６と当接する当接部材５０１と、収集部材２１を保持する収集部材保持部材５０２とを含んでいる。   In the third embodiment, as shown in FIG. 30, 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.

当接部材５０１は、中央部に形成された開口部５０１ａと、皮膚当接側の面に設けられた接着部５０１ｂと、微細孔形成装置４のリブ４ｆ（図１参照）と係合する凹形状の係合部５０１ｃとを含んでいる。また、図３１に示すように、収集部材保持部材５０２の外縁の形状は、当接部材５０１の開口部５０１ａの内縁の形状と略同じで、かつ、当接部材５０１の開口部５０１ａの大きさよりも若干小さくなるように構成されている。これにより、当接部材５０１の開口部５０１ａに収集部材保持部材５０２を嵌め込んだ場合に、収集部材保持部材５０２に保持された収集部材２１のゲル部材２４が開口部５０１ａの中央位置に位置するように構成されている。   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. Further, as shown in FIG. 31, 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. Thereby, when the collection member holding member 502 is fitted in the opening 501a of the contact member 501, 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.

次に、図７、図３０および図３１を参照して、第３実施形態による生体内成分測定システムによる測定手順について説明する。   Next, with reference to FIG. 7, FIG. 30, and FIG. 31, a measurement procedure by the in-vivo component measurement system according to the third embodiment will be described.

まず、被験者は、包装部材２３（図７参照）から組織液収集装置５００を取り出す。そして、上記第１実施形態と同様に、当接部材５０１の剥離シート２９ｂ（図３０参照）を剥がすことにより接着部５０１ｂを露出させた状態で、当接部材５０１を皮膚６に付着させる。   First, 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.

次に、被験者は、微細孔形成装置４のリブ４ｆと当接部材５０１の係合部５０１ｃとを係合させて微細孔形成装置４を当接部材５０１に対して位置決めした状態で、微細孔形成装置４により穿刺を行う。これにより、微細孔形成領域６ｂが、当接部材５０１の開口部５０１ａの中央位置に形成される。この後、被験者は、微細孔形成装置４および微細針チップ５を皮膚６から取り外す。   Next, 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.

次に、被験者は、収集部材保持部材５０２の剥離シート２９ａを剥がすことにより、ゲル部材２４および収集部材２１の接着部２１ａを露出させる。そして、図３１に示すように、収集部材保持部材５０２の外縁と当接部材５０１の開口部５０１ａの内縁とが合うように収集部材保持部材５０２を当接部材５０１の開口部５０１ａ内に配置する。これにより、収集部材保持部材５０２に保持されたゲル部材２４が微細孔形成領域６ｂ上に配置される。そして、被験者が収集部材保持部材５０２をさらに皮膚６側に押圧すると、ゲル部材２４が微細孔形成領域６ｂ上に配置された状態で、ゲル保持部材２５の接着部２１ａが皮膚６に接着される。   Next, the subject exposes the adhesive portion 21a of the gel member 24 and the collection member 21 by peeling off the release sheet 29a of the collection 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. .

この後、被験者は、組織液の収集中には使用されない当接部材５０１および収集部材保持部材５０２を皮膚６から離間させて取り除く。収集部材２１は収集部材保持部材５０２に接着部２１ｂの接着力により接着されているが、接着部２１ｂの収集部材保持部材５０２に対する接着力が接着部２１ａの皮膚６に対する接着力よりも小さい。このため、収集部材保持部材５０２を皮膚６から離間させた場合、収集部材２１が皮膚６に付着した状態で、収集部材２１と収集部材保持部材５０２との接着が外れる。また、当接部材５０１は簡単に皮膚６から外すことが可能である。   Thereafter, the 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.

この後、組織液を収集した収集部材２１について、測定装置３を用いて上記第１実施形態と同様の測定を行う。   Thereafter, the measurement member 3 that collects the tissue fluid is subjected to the same measurement as in the first embodiment using the measurement device 3.

第３実施形態では、収集部材保持部材５０２と当接部材５０１とを別体として形成するとともに、収集部材保持部材５０２の外縁の形状に対応するように当接部材５０１の開口部５０１ａの内縁の形状を形成している。これにより、収集部材保持部材５０２と当接部材５０１とが別体である場合にも、収集部材保持部材５０２の外縁の形状を当接部材５０１の開口部５０１ａの内縁の形状に合わせるように収集部材保持部材５０２を当接部材５０１の開口部５０１ａ内に配置すれば、収集部材保持部材５０２を当接部材５０１に対して所定の位置（収集部材２１のゲル部材２４が微細孔形成領域６ｂに位置するような位置）に位置決めすることができる。これにより、被験者は、確実に収集部材２１を微細孔形成領域６ｂに付着させて組織液の収集を行うことができる。   In the third embodiment, 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. Thus, even when 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. If the member holding member 502 is disposed in the opening 501a of the abutting 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.

第３実施形態のその他の効果は、上記第１実施形態と同様である。   Other effects of the third embodiment are the same as those of the first embodiment.

なお、今回開示された実施形態は、すべての点で例示であって制限的なものではないと考えられるべきである。本発明の範囲は、上記した実施形態の説明ではなく特許請求の範囲によって示され、さらに特許請求の範囲と均等の意味および範囲内でのすべての変更が含まれる。   The embodiment disclosed this time should be considered as illustrative in all points and not restrictive. The scope of the present invention is shown not by the above description of the embodiments but by the scope of claims for patent, and further includes all modifications within the meaning and scope equivalent to the scope of claims for patent.

たとえば、上記第１〜第３実施形態では、本発明の「皮膚透過亢進処理」の一例として、微細孔形成装置４を用いて微細孔形成領域６ｂを形成した例を示したが、本発明はこれに限らず、皮膚に超音波を照射して、皮膚のバリア機能を低下させることにより受動拡散を促進させてもよいし、皮膚の組織液抽出部位に組織液の経皮移動を促進するためのエンハンサー（アルコールなどの界面活性剤）を付与してもよい。   For example, in the first to third embodiments, as an example of the “skin permeation enhancement process” of the present invention, an example in which the micropore forming region 6b is formed using the micropore forming device 4 is shown. Not limited to this, 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.

また、上記第１〜第３実施形態では、ゲル部材２４を用いて組織液を収集した例を示したが、本発明はこれに限らず、メッシュシート、シート状の紙片、または、シート状でない紙片やナイロンなどを用いてもよい。   Moreover, in the said 1st-3rd embodiment, although the example which collected the tissue fluid using the gel member 24 was shown, this invention is not restricted to this, A mesh sheet, a sheet-like paper piece, or a non-sheet-like paper piece Or nylon may be used.

また、上記第１〜第３実施形態では、ゲル部材２４としてポリビニルアルコールからなるゲルを使用した例を示したが、本発明はこれに限らず、セルロースまたはポリアクリル酸からなるゲルを使用してもよい。   Moreover, although the example which used the gel which consists of polyvinyl alcohol as the gel member 24 was shown in the said 1st-3rd embodiment, this invention is not limited to this, The gel which consists of cellulose or polyacrylic acid is used. Also good.

また、上記第１〜第３実施形態では、組織液中のグルコース量を測定した例を示したが、本発明はこれに限らず、組織液中に含まれるグルコース以外の物質の量を測定してもよい。本発明により測定される物質としては、たとえば、生化学成分や被験者に投与された薬剤などが挙げられる。生化学成分としては、生化学成分の一種であるたんぱく質の、アルブミン、グロブリンおよび酵素などが挙げられる。また、たんぱく質以外の生化学成分として、クレアチニン、クレアチン、尿酸、アミノ酸、フルクトース、ガラクトース、ペントース、グリコーゲン、乳酸、ピルビン酸およびケトン体などが挙げられる。また、薬剤としては、ジギタリス製剤、テオフィリン、不整脈用剤、抗てんかん剤、アミノ酸糖体抗生物質、グリコペプチド系抗生物質、抗血栓剤および免疫抑制剤などが挙げられる。   Moreover, although the example which measured the glucose amount in a tissue fluid was shown in the said 1st-3rd embodiment, this invention is not restricted to this, Even if it measures the quantity of substances other than the glucose contained in a tissue fluid Good. Examples of substances measured by the present invention include biochemical components and drugs administered to subjects. Examples of biochemical components include proteins such as albumin, globulin, and enzymes, which are a kind of biochemical components. Examples of biochemical components other than protein include creatinine, creatine, uric acid, amino acids, fructose, galactose, pentose, glycogen, lactic acid, pyruvic acid, and ketone bodies. Examples of the drug include digitalis preparations, theophylline, arrhythmic agents, antiepileptic agents, amino acid saccharide antibiotics, glycopeptide antibiotics, antithrombotic agents, and immunosuppressive agents.

また、上記第３実施形態では、収集部材保持部材５０２の外縁の形状に対応するように当接部材５０１の開口部５０１ａの内縁の形状を形成することにより、収集部材保持部材５０２を当接部材５０１に対して所定の位置（ゲル部材２４が微細孔形成領域６ｂに位置するような位置）に位置決め可能なように構成した。ここで、本発明はこれに限らず、図３２に示す第３実施形態の変形例の組織液収集装置６００のように、当接部材６０１に孔状の係合部６０１ａを設けるとともに、収集部材保持部材６０２に当接部材６０１の係合部６０１ａに対応する位置にボス状の係合部６０２ａを設けてもよい。これにより、当接部材６０１の係合部６０１ａと収集部材保持部材６０２の係合部６０２ａとを係合させることにより、容易に、収集部材保持部材６０２を当接部材６０１に対して所定の位置（ゲル部材２４が微細孔形成領域６ｂに位置するような位置）に位置決めすることができる。   In the third embodiment, 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). Here, 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. As a result, the collecting member holding member 602 is easily positioned at 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.

また、当接部材と収集部材保持部材とが別体の場合に、当接部材および収集部材保持部材のそれぞれに互いに対応するマークを付しておくことにより、被験者がそのマークを目印として、収集部材保持部材を当接部材に対して所定の位置（収集部材が組織液抽出部位に位置するような位置）に位置決めするように構成してもよい。また、当接部材と収集部材保持部材とが別体の場合には、収集部材を皮膚に付着させた後に、当接部材および収集部材保持部材のいずれか一方を皮膚から取り外すだけでもよい。   In addition, when 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.

また、上記第１〜第３実施形態では、収集部材に収集された組織液のグルコース濃度を直接的に測定した例を示したが、本発明はこれに限らず、グルコースを他の物質に置換した後に、その物質の濃度を測定してもよい。   Moreover, in the said 1st-3rd embodiment, although the example which measured the glucose concentration of the tissue fluid collected by the collection member directly was shown, this invention is not restricted to this, The glucose was substituted with the other substance. Later, the concentration of the substance may be measured.

また、上記第１実施形態では、収集部材保持部２７と当接部２６とが第１位置Ｐにおいて係合しない例を示したが、本発明はこれに限らず、図３３に示す第１実施形態の変形例による組織液収集装置７００のように、収集部材保持部２７と当接部２６とがヒンジ部２８が閉じた第１位置Ｐにおいて係合するように構成してもよい。具体的には、組織液収集装置７００では、収集部材保持部２７に凸状の係合部７０１が設けられているとともに、当接部２６に収集部材保持部２７の係合部７０１に対応する位置に切欠形状の係合部７０２が設けられている。また、ヒンジ部２８の折り曲げ部分から係合部７０１の先端部までの長さＬ１がヒンジ部２８の折り曲げ部分から係合部７０２の先端部までの長さＬ２よりも僅かに大きくなるように構成されている。これにより、ヒンジ部２８を折り曲げ部分において折り曲げることにより収集部材保持部２７を第１位置Ｐに移動させた場合に、係合部７０１の先端部が係合部７０２の先端部の下側に撓みながら入り込むことによって係合部７０１と係合部７０２とを係合させることができる。このように構成することによって、被験者は、係合部７０１と係合部７０２とが係合したことを確認することによって、収集部材保持部２７に保持された収集部材２４が皮膚に接触するまで押さえつけられたことを確認することができる。また、係合部７０１と係合部７０２とが係合していることにより、収集部材保持部２７が第２位置Ｑに移動することを抑制することができるので、被験者は、本体２２を皮膚から離間させる際に、収集部材保持部２７を当接部２６側に押さえつけておく必要がなくなる。これにより、被験者が容易に本体２２を皮膚から離間させることができる。   Moreover, in the said 1st Embodiment, although the collection member holding | 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. As in the tissue fluid collection device 700 according to the modification of the form, 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. Specifically, in the tissue fluid collection device 700, the collection member holding portion 27 is provided with a convex engagement portion 701, and the contact portion 26 is a position corresponding to the engagement portion 701 of the collection member holding portion 27. Is provided with a notch-shaped engaging portion 702. Further, 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. Thereby, when the collecting 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. It can be confirmed that it has been pressed down. In addition, since the engaging member 701 and the engaging portion 702 are engaged, it is possible to suppress the collection member holding portion 27 from moving to the second position Q. It is not necessary to hold the collecting member holding part 27 against the abutting part 26 side when separating from the position. As a result, the subject can easily separate the main body 22 from the skin.

１ 生体内成分測定システム
２ 組織液収集装置
２１ 収集部材
２１ａ 接着部（第１接着部）
２１ｂ 接着部（第２接着部）
２４ ゲル部材（収集体）
２５ ゲル保持部材（収集体保持部）
２６ 当接部（当接部材）
２６ｂ 接着部（第３接着部）
２６ｃ 係合部（第１位置決め部）
２７ 収集部材保持部（収集部材保持部材）
２８ ヒンジ部
３ 測定装置
４ 微細孔形成装置（皮膚透過亢進処理装置）
４ｆ リブ（第２位置決め部）
６ 皮膚
６ａ 微細孔
６ｂ 微細孔形成領域（組織液抽出部位）
３００ 組織液収集装置
３０１ 収集部材
３０２ ゲル保持部材（収集体保持部）
３０２ａ 接着部（第２接着部）
３０３ シート部材
３０３ｃ 接着部（第１接着部）
５００ 組織液収集装置
５０１ 当接部材
５０１ｂ 接着部（第３接着部）
５０２ 収集部材保持部材
６００ 組織液収集装置
６０１ 当接部材
６０２ 収集部材保持部材
７００ 組織液収集装置DESCRIPTION OF SYMBOLS 1 Biological component measurement system 2 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 Collection member holding part (collection 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 holding member 700 Tissue fluid collection device

Claims (15)

生体の皮膚と当接する当接部材と、
予め前記当接部材が皮膚に当接された状態で、前記当接部材を位置基準として生体の組織液を抽出し易くする皮膚透過亢進処理を皮膚の所定の部位に対して行うことにより、組織液抽出部位を形成する皮膚透過亢進処理装置と、
組織液を収集する収集部材と、
前記収集部材を保持するとともに、皮膚に当接された前記当接部材を位置基準として、前記収集部材を前記組織液抽出部位に付着させることが可能に構成された収集部材保持部材と、
前記収集部材に収集された組織液に含まれる成分を測定する測定装置とを備え、
前記当接部材および前記収集部材保持部材の少なくともいずれか一方は、前記収集部材を前記組織液抽出部位に付着させた状態で、前記皮膚から離間させることが可能に構成されている、生体内成分測定システム。A contact member that contacts the skin of the living body;
Tissue fluid extraction is performed by performing skin permeation enhancement processing on a predetermined part of the skin to facilitate extraction of biological tissue fluid with the contact member as a position reference in a state where the contact member is in contact with the skin in advance. A skin permeation enhancer that forms a site;
A collecting member for collecting tissue fluid;
A collecting member holding member configured to hold the collecting member and to attach the collecting member to the tissue fluid extraction site with the contact member in contact with the skin as a position reference;
A measuring device for measuring a component contained in the tissue fluid collected in the collecting member,
In vivo component measurement, wherein at least one of the contact member and the collection member holding member is configured to be separated from the skin in a state where the collection member is attached to the tissue fluid extraction site. system. 生体の皮膚に予め当接された状態で、皮膚の所定の部位に組織液を抽出し易くする皮膚透過亢進処理を行うことにより組織液抽出部位を形成する皮膚透過亢進処理装置の位置基準として機能する当接部と、
組織液を収集する収集部材と、
前記収集部材を保持するとともに、皮膚に当接された前記当接部を位置基準として、前記収集部材を前記組織液抽出部位に付着することが可能に構成された収集部材保持部とを備え、
前記当接部および前記収集部材保持部の少なくともいずれか一方は、前記収集部材を前記組織液抽出部位に付着させた状態で、前記皮膚から離間させることが可能に構成されている、組織液収集装置。This function functions as a position reference for a skin permeation enhancement processing device that forms a tissue fluid extraction site by performing a skin permeation enhancement process that facilitates extraction of tissue fluid at a predetermined site on the skin while being in contact with the skin of a living body in advance. The tangent,
A collecting member for collecting tissue fluid;
A holding member configured to hold the collecting member, and to be configured to attach the collecting 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 part and the collection member holding part is a tissue fluid collection device 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. 前記当接部および前記収集部材保持部の両方は、前記収集部材を前記組織液抽出部位に付着させた状態で、前記皮膚から離間させることが可能に構成されている、請求項２に記載の組織液収集装置。  The tissue fluid according to claim 2, wherein both the contact portion and the collection member holding portion are configured to be separated from the skin in a state where the collection member is attached to the tissue fluid extraction site. Collection device. 前記当接部および前記皮膚透過亢進処理装置は、それぞれ、前記皮膚透過亢進処理装置を前記当接部に対して位置決めするための第１位置決め部および第２位置決め部を有しており、
前記皮膚透過亢進処理装置は、前記第１位置決め部および前記第２位置決め部によって前記当接部に対して位置決めされた状態で前記当接部を位置基準として皮膚透過亢進処理を行うことにより、前記組織液抽出部位を形成するように構成されている、請求項２または３に記載の組織液収集装置。The contact part and the skin permeation enhancement processing apparatus each have a first positioning part and a second positioning part for positioning the skin permeation enhancement processing apparatus with respect to the contact part,
The skin permeation enhancement processing apparatus performs the skin permeation enhancement processing using the contact portion as a position reference while being positioned with respect to the contact portion by the first positioning portion and the second positioning portion. The tissue fluid collection device according to claim 2 or 3, wherein the tissue fluid collection device is configured to form a tissue fluid extraction site. 前記収集部材保持部は、前記収集部材を前記組織液抽出部位に付着させた状態で、皮膚から離間させることが可能に構成されており、
前記収集部材は、前記収集部材保持部に接着されることにより前記収集部材保持部に保持されており、
前記収集部材が前記組織液抽出部位に付着された場合に、前記収集部材が前記組織液抽出部位に接着されるとともに、前記収集部材保持部が皮膚から離間された場合に、前記収集部材保持部と前記収集部材との接着が外れるように構成されている、請求項２〜４のいずれか１項に記載の組織液収集装置。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 held by the collecting member holding unit by being bonded to the collecting member holding unit,
When the collecting member is attached to the tissue fluid extraction site, the collecting member is adhered to the tissue fluid extraction site, and when the collecting member holding unit is separated from the skin, the collecting member holding unit and the The tissue fluid collection device according to any one of claims 2 to 4, wherein the tissue fluid collection device is configured to release adhesion to the collection member. 前記収集部材は、
組織液を収集して保持する収集体と、
前記収集体を保持するとともに、皮膚と接着される第１接着部と、前記収集部材保持部と接着される第２接着部とを有する収集体保持部とを含み、
前記第１接着部の皮膚に対する接着力は、前記第２接着部の前記収集部材保持部に対する接着力よりも大きい、請求項５に記載の組織液収集装置。The collecting member is
A collector that collects and holds tissue fluid; and
A collection body holding section that holds the collection body, and has a first bonding section that is bonded to the skin, and a second bonding section that is bonded to the collection member holding section,
The tissue fluid collection device according to claim 5, wherein an adhesive force of the first adhesive portion to the skin is larger than an adhesive force of the second adhesive portion to the collection member holding portion. 前記収集体保持部の第１接着部と前記皮膚との接着面積は、前記収集体保持部の第２接着部と前記収集部材保持部との接着面積よりも大きい、請求項６に記載の組織液収集装置。  The tissue fluid according to claim 6, wherein an adhesion area between the first adhesion part of the collection body holding part and the skin is larger than an adhesion area between the second adhesion part of the collection object holding part and the collection member holding part. Collection device. 前記収集体保持部は、フィルム状に形成されている、請求項６または７に記載の組織液収集装置。  The tissue fluid collection device according to claim 6 or 7, wherein the collection body holding unit is formed in a film shape. 前記収集体保持部は、不透湿性を有する、請求項６〜８のいずれか１項に記載の組織液収集装置。  The tissue fluid collection device according to any one of claims 6 to 8, wherein the collection body holding part has moisture permeability. 前記収集体は、ゲル部材からなる、請求項６〜９のいずれか１項に記載の組織液収集装置。  The tissue fluid collection device according to any one of claims 6 to 9, wherein the collection body is made of a gel member. 前記収集部材保持部と前記当接部とは、一体的に形成されている、請求項２〜１０のいずれか１項に記載の組織液収集装置。  The tissue fluid collection device according to any one of claims 2 to 10, wherein the collection member holding portion and the contact portion are integrally formed. 前記収集部材保持部および前記当接部と一体的に形成されたヒンジ部をさらに備え、
前記収集部材保持部は、前記当接部に対して、前記ヒンジ部が折りたたまれた第１位置と、前記ヒンジ部が開いた第２位置とに変位可能に構成されており、
前記収集部材保持部が前記第２位置に位置する状態で、前記皮膚透過亢進処理装置によって皮膚透過亢進処理が行われることにより前記組織液抽出部位が形成され、前記収集部材保持部が前記第１位置に位置する状態で、前記収集部材保持部に保持された前記収集部材が前記組織液抽出部位に付着するように構成されている、請求項１１に記載の組織液収集装置。A hinge part formed integrally with the collecting member holding part and the contact part;
The collection member holding part is configured to be displaceable with respect to the contact part between a first position where the hinge part is folded and a second position where the hinge part is opened,
The tissue fluid extraction site is formed by performing skin permeation enhancement processing by the skin permeation enhancement processing device in a state where the collection member holding portion is located at the second position, and the collection member holding portion is located at the first position. The tissue fluid collection device according to claim 11, wherein the collection member held by the collection member holding portion is configured to adhere to the tissue fluid extraction site in a state of being located at a position. 前記当接部は、皮膚と当接して皮膚と接着される第３接着部を含む、請求項２〜１２のいずれか１項に記載の組織液収集装置。  The tissue fluid collection device according to any one of claims 2 to 12, wherein the contact portion includes a third adhesive portion that contacts the skin and adheres to the skin. 請求項２〜１３のいずれか１項に記載の前記組織液収集装置によって、前記収集部材を前記組織液抽出部位に付着させ、
前記当接部および前記収集部材保持部の少なくともいずれか一方を、前記収集部材を前記組織液抽出部位に付着させた状態で、前記皮膚から離間させ、
１時間以上にわたって前記組織液抽出部位に付着された前記収集部材によって収集された組織液に含まれる成分を測定する、生体内成分測定方法。The tissue fluid collection device according to any one of claims 2 to 13, wherein the collection member is attached to the tissue fluid extraction site,
At least one of the contact part and the collection member holding part is separated from the skin in a state where the collection member is attached to the tissue fluid extraction site,
An in-vivo component measurement method for measuring a component contained in a tissue fluid collected by the collecting member attached to the tissue fluid extraction site for 1 hour or more. 前記成分が、グルコースである、請求項１４に記載の生体内成分測定方法。  The in vivo component measurement method according to claim 14, wherein the component is glucose.
JP2010538242A 2009-02-27 2010-02-24 In vivo component measurement system, tissue fluid collection device, and in vivo component measurement method Expired - Fee Related JP4643768B2 (en)

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PCT/JP2010/052826 WO2010098339A1 (en) 2009-02-27 2010-02-24 System for assaying in vivo component, device for collecting tissue fluid and method for assaying in vivo component

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