JPWO2019155688A1 - Indwelling device and base member - Google Patents

Indwelling device and base member Download PDF

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JPWO2019155688A1
JPWO2019155688A1 JP2019570294A JP2019570294A JPWO2019155688A1 JP WO2019155688 A1 JPWO2019155688 A1 JP WO2019155688A1 JP 2019570294 A JP2019570294 A JP 2019570294A JP 2019570294 A JP2019570294 A JP 2019570294A JP WO2019155688 A1 JPWO2019155688 A1 JP WO2019155688A1
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needle member
needle
living body
moving
insertion mechanism
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JP7117333B2 (en
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中西 勝
勝 中西
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Terumo Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter

Abstract

本開示に係る留置装置は、生体に装着される装着面を備える装置本体と、針部材と、を備え、前記装置本体は、前記針部材を前記装着面から突出させることで前記生体内に前記針部材を挿入する挿入機構を備え、前記挿入機構は、前記針部材に当接し、前記針部材の中心軸線を含む面内で前記針部材を回動させるガイド部を備える。The indwelling device according to the present disclosure includes a device main body having a mounting surface to be mounted on a living body and a needle member, and the device main body is said to be in the living body by projecting the needle member from the mounting surface. The insertion mechanism includes an insertion mechanism for inserting the needle member, and the insertion mechanism includes a guide portion that comes into contact with the needle member and rotates the needle member in a plane including the central axis of the needle member.

Description

本開示は留置装置及びベース部材に関する。 The present disclosure relates to an indwelling device and a base member.

従来から、患者などの被検者の体内にセンサ部を挿入又は埋め込み、被検者の血液又は体液中の被計測物質(例えば、グルコースやpH、生理活性物質、たんぱく質等)を該センサ部によって検出することが行われている。 Conventionally, a sensor unit is inserted or embedded in the body of a subject such as a patient, and a substance to be measured (for example, glucose, pH, a physiologically active substance, a protein, etc.) in the blood or body fluid of the subject is subjected to the sensor unit. It is being detected.

特許文献1には、連続グルコースモニタ(Continuous Glucose Monitoring、略称「CGM」)に用いられるモニタリング装置が開示されている。特許文献1に記載のモニタリング装置は、センサ及び穿刺刃部材を皮下に挿入し、穿刺刃部材をセンサから分離した状態で皮下から引き抜いて回収する。 Patent Document 1 discloses a monitoring device used for a continuous glucose monitor (Continuous Glucose Monitoring, abbreviated as "CGM"). In the monitoring device described in Patent Document 1, the sensor and the puncture blade member are inserted subcutaneously, and the puncture blade member is pulled out from the subcutaneous part in a state of being separated from the sensor and collected.

特許第5748595号公報Japanese Patent No. 5748595

特許文献1に記載のモニタリング装置のような留置装置では、その一部が生体表面上に留置される。生体表面からの突出量(厚み)が大きいと、被検者や患者などのユーザーの日常生活が阻害され易い。このようなユーザーの負担を軽減するため、留置装置は薄肉化されることが好ましい。 In an indwelling device such as the monitoring device described in Patent Document 1, a part thereof is indwelled on the surface of a living body. If the amount of protrusion (thickness) from the surface of the living body is large, the daily life of users such as subjects and patients is likely to be hindered. In order to reduce such a burden on the user, it is preferable that the indwelling device is thinned.

その一方で、留置装置を薄肉化すると、センサ及び穿刺刃部材を生体表面から生体内の所定の深さまで挿入する挿入機構を一体化した構成が実現し難くなる。 On the other hand, if the indwelling device is made thinner, it becomes difficult to realize a configuration in which an insertion mechanism for inserting the sensor and the puncture blade member from the surface of the living body to a predetermined depth in the living body is integrated.

そこで本開示は、針部材の生体内での挿入深さを確保しつつ、針部材の挿入機構を含む、生体表面上に留置される部分の厚みを薄肉化できる構成を備える留置装置及びベース部材を提供することを目的とする。 Therefore, the present disclosure discloses an indwelling device and a base member having a configuration capable of reducing the thickness of a portion to be indwelled on the surface of the living body, including an insertion mechanism of the needle member, while ensuring the insertion depth of the needle member in the living body. The purpose is to provide.

本開示の第1の態様としての留置装置は、生体に装着される装着面を備える装置本体と、針部材と、を備え、前記装置本体は、前記針部材を前記装着面から突出させることで前記生体内に前記針部材を挿入する挿入機構を備え、前記挿入機構は、前記針部材に当接し、前記針部材の中心軸線を含む面内で前記針部材を回動させるガイド部を備える。 The indwelling device as the first aspect of the present disclosure includes a device main body including a mounting surface to be mounted on a living body and a needle member, and the device main body projects the needle member from the mounting surface. An insertion mechanism for inserting the needle member into the living body is provided, and the insertion mechanism includes a guide portion that comes into contact with the needle member and rotates the needle member in a plane including the central axis of the needle member.

本開示の1つの実施形態として、前記挿入機構は、前記針部材を所定の一方向に移動させることが可能な移動部を備え、前記ガイド部は、前記移動部により移動している前記針部材に当接し、前記中心軸線を含む面内で前記針部材を回動させ、前記針部材の先端の進行方向を前記所定の一方向から変化させる。 As one embodiment of the present disclosure, the insertion mechanism includes a moving portion capable of moving the needle member in a predetermined direction, and the guide portion is the needle member moved by the moving portion. The needle member is rotated in a plane including the central axis, and the traveling direction of the tip of the needle member is changed from the predetermined one direction.

本開示の1つの実施形態として、前記針部材の基端部は、前記移動部により前記所定の一方向に移動しているときに、前記移動部に対して、前記所定の一方向と直交する方向に移動可能である。 As one embodiment of the present disclosure, the base end portion of the needle member is orthogonal to the predetermined one direction with respect to the moving portion when the base end portion of the needle member is moved in the predetermined one direction by the moving portion. It is movable in the direction.

本開示の1つの実施形態として、前記ガイド部は、前記所定の一方向と略直交し、前記装着面に向かう方向に、前記針部材の前記先端の進行方向を変化させる。 In one embodiment of the present disclosure, the guide portion is substantially orthogonal to the predetermined one direction and changes the traveling direction of the tip of the needle member in a direction toward the mounting surface.

本開示の1つの実施形態として、前記ガイド部は、前記中心軸線を含む断面において、前記所定の一方向に向かうにつれて前記装着面に近づくように延在する円弧状の湾曲面により構成されている。 As one embodiment of the present disclosure, the guide portion is composed of an arcuate curved surface extending toward the mounting surface in a cross section including the central axis in a predetermined direction. ..

本開示の1つの実施形態としての留置装置は、前記生体内に挿入され、前記生体内の被計測物質を検出可能な検出部材と、前記検出部材を支持する支持部材と、を備え、前記挿入機構の移動部は、前記針部材を前記所定の一方向とは逆方向に戻り移動させることが可能であり、前記針部材が前記挿入機構の前記移動部により前記所定の一方向に移動する場合に、前記検出部材及び前記支持部材は、前記検出部材が前記針部材の内部に延在する状態で、前記針部材と共に前記所定の一方向に移動し、かつ、前記針部材と共に前記挿入機構の前記ガイド部により回動することで、前記針部材が前記逆方向に戻り移動する際に追従して移動しない姿勢へと変化する。 The indwelling device as one embodiment of the present disclosure includes a detection member that is inserted into the living body and can detect the substance to be measured in the living body, and a support member that supports the detection member, and the insertion. The moving portion of the mechanism can return and move the needle member in a direction opposite to the predetermined one direction, and the needle member is moved in the predetermined one direction by the moving portion of the insertion mechanism. In addition, the detection member and the support member move in a predetermined direction together with the needle member in a state where the detection member extends inside the needle member, and together with the needle member, the insertion mechanism of the insertion mechanism. By rotating by the guide portion, the needle member changes to a posture in which the needle member does not move following the return movement in the opposite direction.

本開示の1つの実施形態として、前記挿入機構の前記移動部は、磁力又は弾性力を用いて前記針部材を移動させる。 As one embodiment of the present disclosure, the moving portion of the insertion mechanism uses magnetic force or elastic force to move the needle member.

本開示の1つの実施形態として、前記針部材は円弧状に湾曲して延在する円弧針である。 As one embodiment of the present disclosure, the needle member is an arc needle that is curved and extends in an arc shape.

本開示の第2の態様としての留置装置は、生体に装着される装着面を備える装置本体と、針部材と、を備え、前記装置本体は、前記針部材を前記装着面から突出させることで前記生体内に挿入する挿入機構を備え、前記挿入機構は、前記針部材を所定の一方向、及び、前記所定の一方向の逆方向、に移動させることが可能な移動部を備え、前記移動部は、引力及び斥力の一方の磁力により、前記針部材を前記所定の一方向に移動させ、他方の磁力により、前記針部材を前記逆方向に移動させる。 The indwelling device as the second aspect of the present disclosure includes a device main body including a mounting surface to be mounted on a living body and a needle member, and the device main body projects the needle member from the mounting surface. The insertion mechanism includes an insertion mechanism for inserting into the living body, and the insertion mechanism includes a moving portion capable of moving the needle member in a predetermined one direction and the opposite direction of the predetermined one direction. The unit moves the needle member in the predetermined one direction by one magnetic force of attractive force and repulsive force, and moves the needle member in the opposite direction by the other magnetic force.

本開示の第3の態様としてのベース部材は、通信装置を含むカバー部材を取り付け可能であると共に、生体に装着される装着面を備えるベース部材であって、針部材と、前記針部材を前記装着面から突出させることで前記針部材を前記生体内に挿入する挿入機構と、を備え、前記挿入機構は、前記針部材に当接し、前記針部材の中心軸線を含む面内で前記針部材を回動させるガイド部を備える。 The base member as the third aspect of the present disclosure is a base member to which a cover member including a communication device can be attached and has a mounting surface to be mounted on a living body, and the needle member and the needle member are attached to the needle member. An insertion mechanism for inserting the needle member into the living body by projecting from the mounting surface is provided, and the insertion mechanism abuts on the needle member and the needle member is in contact with the needle member in a plane including the central axis of the needle member. A guide portion for rotating the

本開示によれば、針部材の生体内での挿入深さを確保しつつ、針部材の挿入機構を含む、生体表面上に留置される部分の厚みを薄肉化できる構成を備える留置装置及びベース部材を提供することができる。 According to the present disclosure, an indwelling device and a base having a configuration capable of reducing the thickness of a portion to be indwelled on the surface of a living body, including an insertion mechanism of the needle member, while ensuring an insertion depth of the needle member in the living body. Members can be provided.

未使用状態の留置装置の上面側を示す斜視図である。It is a perspective view which shows the upper surface side of the indwelling apparatus in an unused state. 図1に示す留置装置の下面側を示す斜視図である。It is a perspective view which shows the lower surface side of the indwelling apparatus shown in FIG. 図2に示す状態から針部材を突出させた状態に状態変化させた留置装置の下面側を示す斜視図である。It is a perspective view which shows the lower surface side of the indwelling apparatus which changed the state from the state shown in FIG. 2 to the state which the needle member protruded. 図1に示す留置装置の上面図である。It is a top view of the indwelling device shown in FIG. 図4のI−I線に沿う断面図である。It is sectional drawing which follows the line I-I of FIG. 図3に示す留置装置についての、図5と同断面を示す断面図である。It is sectional drawing which shows the same cross section as FIG. 5 about the indwelling apparatus shown in FIG. 未使用状態の留置装置を生体表面に装着する装着工程を示す図である。It is a figure which shows the mounting process which mounts an unused indwelling apparatus on a living body surface. 図7Aに示す留置装置の針部材及び検出部材を生体内に挿入する挿入工程を示す図である。It is a figure which shows the insertion process which inserts the needle member and the detection member of the indwelling apparatus shown in FIG. 7A into a living body. 図7Bで挿入した検出部材を生体内に留置したまま、針部材を生体外に抜去する抜去工程を示す図である。FIG. 7B is a diagram showing a removal step of removing a needle member from the living body while keeping the detection member inserted in FIG. 7B in the living body. 図7Cに示す留置装置を生体から取り外す取り外し工程を示す図である。It is a figure which shows the removal process which removes the indwelling apparatus shown in FIG. 7C from a living body. 未使用状態の留置装置を分解した分解斜視図である。It is an exploded perspective view which disassembled the indwelling apparatus in an unused state. 図1に示す留置装置のベース部材を、台座カバー部材と、それ以外と、に分解した分解斜視図である。It is an exploded perspective view which disassembled the base member of the indwelling apparatus shown in FIG. 1 into a pedestal cover member and other parts. 図1に示す留置装置のベース部材を、台座カバー部材と、針部材、検出部材、スライダー、針保持部材及び支持部材を含む部材群と、駆動装置と、台座部材、駆動制御部材、回路基板及び操作部材を含む部材群と、の4つの部分に分解した分解斜視図である。The base member of the indwelling device shown in FIG. 1 includes a pedestal cover member, a group of members including a needle member, a detection member, a slider, a needle holding member, and a support member, a drive device, a pedestal member, a drive control member, a circuit board, and the like. It is an exploded perspective view disassembled into four parts of a member group including an operation member. 図8に示すベース部材及びカバー部材それぞれの、図5及び図6に示す断面と同位置での断面図である。It is sectional drawing of each of the base member and cover member shown in FIG. 8 at the same position as the cross section shown in FIGS. 5 and 6. 図8に示すベース部材のうち、針部材、検出部材、針保持部材及び支持部材のみを示す図である。Of the base members shown in FIG. 8, only the needle member, the detection member, the needle holding member, and the support member are shown. 図8に示すベース部材のうち、回動部の下面を示す図である。It is a figure which shows the lower surface of the rotating part among the base members shown in FIG. 未使用状態の留置装置におけるベース部材を示す図である。It is a figure which shows the base member in the indwelling apparatus in an unused state. 図13Aの状態から挿入機構を作動させ、針部材及び検出部材を装着面から最も突出させた状態のベース部材を示す図である。FIG. 13A is a diagram showing a base member in a state in which the insertion mechanism is operated from the state of FIG. 13A and the needle member and the detection member are most projected from the mounting surface. 図13Bの状態からスライダーを抜去移動方向に戻り移動させ、検出部材を装着面から突出させた状態のまま、針部材のみを引き戻して内部に収容した状態のベース部材を示す図である。FIG. 13B is a diagram showing a base member in a state in which the slider is pulled back from the state of FIG. 13B and moved back in the moving direction, and only the needle member is pulled back and housed inside while the detection member is projected from the mounting surface. 未使用状態の、変形例としての留置装置におけるベース部材を示す図である。It is a figure which shows the base member in the indwelling apparatus as a modification of an unused state. 図14Aの状態から挿入機構を作動させ、針部材及び検出部材を装着面から最も突出させた状態のベース部材を示す図である。FIG. 14 is a diagram showing a base member in a state in which the insertion mechanism is operated from the state of FIG. 14A and the needle member and the detection member are most projected from the mounting surface. 図14Bの状態からスライダーを抜去移動方向に戻り移動させ、検出部材を装着面から突出させた状態のまま、針部材のみを引き戻して内部に収容した状態のベース部材を示す図である。FIG. 14B is a diagram showing a base member in a state in which the slider is pulled back from the state of FIG. 14B and moved in the moving direction, and only the needle member is pulled back and housed inside while the detection member is projected from the mounting surface. 図14Aに示すベース部材の駆動装置の詳細を示す断面図である。It is sectional drawing which shows the detail of the drive device of the base member shown in FIG. 14A.

以下、本開示に係る留置装置及びベース部材の実施形態について、図1〜図15を参照して説明する。各図において共通する部材・部位には同一の符号を付している。 Hereinafter, embodiments of the indwelling device and the base member according to the present disclosure will be described with reference to FIGS. 1 to 15. The same reference numerals are given to common members and parts in each figure.

図1は、本実施形態の留置装置1の上面側を示す斜視図である。図2は、本実施形態の留置装置1の下面側を示す斜視図である。図3は、図1、図2に示す状態から針部材2を突出させた状態に状態変化させた留置装置1の下面側を示す斜視図である。 FIG. 1 is a perspective view showing the upper surface side of the indwelling device 1 of the present embodiment. FIG. 2 is a perspective view showing the lower surface side of the indwelling device 1 of the present embodiment. FIG. 3 is a perspective view showing the lower surface side of the indwelling device 1 in which the state of the needle member 2 is changed from the state shown in FIGS. 1 and 2 to a state in which the needle member 2 is projected.

図1〜図3に示すように、留置装置1は、針部材2と、装置本体3と、を備える。装置本体3は、挿入機構を備える。挿入機構により、針部材2を生体表面から生体内に挿入することができる。具体的に、挿入機構を動作させることにより、針部材2が装置本体3の外方に突出しない状態(図2参照)から、針部材2が装置本体3の外方に突出する状態(図3参照)へと、状態を変化させることができる。すなわち、挿入機構により、針部材2を、装置本体3の装着面3aから外方に突出させることができる。装置本体3の装着面3aとは、生体に装着される面である。より具体的に、装置本体3の装着面3aとは、留置装置1を生体へ装着する際に、生体表面に接触する接触面である。挿入機構による上述の突出動作により、針部材2を生体内に挿入することができる。 As shown in FIGS. 1 to 3, the indwelling device 1 includes a needle member 2 and a device main body 3. The device main body 3 includes an insertion mechanism. The insertion mechanism allows the needle member 2 to be inserted into the living body from the surface of the living body. Specifically, by operating the insertion mechanism, the needle member 2 does not project outward from the device body 3 (see FIG. 2), and the needle member 2 projects outward from the device body 3 (FIG. 3). The state can be changed to (see). That is, the insertion mechanism allows the needle member 2 to protrude outward from the mounting surface 3a of the device main body 3. The mounting surface 3a of the device main body 3 is a surface to be mounted on a living body. More specifically, the mounting surface 3a of the device main body 3 is a contact surface that comes into contact with the surface of the living body when the indwelling device 1 is mounted on the living body. The needle member 2 can be inserted into the living body by the above-mentioned protruding operation by the insertion mechanism.

装置本体3の装着面3aには、装置本体3の生体表面上での位置を維持可能にする装着部が設けられている。装着部は、例えば、接着剤、粘着剤等から構成される、生体表面に貼着可能な貼着部とすることができる。 The mounting surface 3a of the device main body 3 is provided with a mounting portion capable of maintaining the position of the device main body 3 on the surface of the living body. The attachment portion can be, for example, an attachment portion made of an adhesive, an adhesive, or the like and which can be attached to the surface of a living body.

図4は、図1、図2に示す留置装置1の上面図である。図5は、図4のI−I線に沿う断面図である。換言すれば、図5は、針部材2が外方に突出しない状態での断面図である。これに対して、図6は、図3に示す留置装置1についての、図5と同断面を示す断面図である。換言すれば、図6は、針部材2が外方に突出する状態での、図5と同断面を示す断面図である。 FIG. 4 is a top view of the indwelling device 1 shown in FIGS. 1 and 2. FIG. 5 is a cross-sectional view taken along the line II of FIG. In other words, FIG. 5 is a cross-sectional view in a state where the needle member 2 does not protrude outward. On the other hand, FIG. 6 is a cross-sectional view showing the same cross section as that of FIG. 5 for the indwelling device 1 shown in FIG. In other words, FIG. 6 is a cross-sectional view showing the same cross section as that of FIG. 5 in a state where the needle member 2 projects outward.

図5、図6に示すように、挿入機構は、針部材2に当接し、針部材2の中心軸線Oを含む面内で、針部材2を穿刺方向へ向かって回動させるガイド部61を備える。針部材2の中心軸線Oとは、針部材2の長手方向である延在方向Aに延びる中心軸線を意味する。また、針部材2の中心軸線Oを含む面とは、針部材2の中心軸線Oのうち、少なくとも装着面3aから突出可能な先端側の部分により特定される中心軸線、を全て含む平面を意味する。このようなガイド部61を備えることで、針部材2を回動させ、針部材2の延在方向Aを変化させることができる。針部材2の延在方向Aとは、針部材2の中心軸線Oに沿う方向である。そのため、留置装置1について、針部材2の生体内での挿入深さを確保しつつ、針部材2の挿入機構を含む、生体表面上に留置される部分の厚みの薄肉化を実現することができる。 As shown in FIGS. 5 and 6, the insertion mechanism abuts the guide portion 61 that abuts on the needle member 2 and rotates the needle member 2 in the puncture direction in the plane including the central axis O of the needle member 2. Be prepared. The central axis O of the needle member 2 means a central axis extending in the extending direction A, which is the longitudinal direction of the needle member 2. Further, the surface including the central axis O of the needle member 2 means a plane including all of the central axis O of the needle member 2 including at least the central axis specified by the portion on the tip side that can protrude from the mounting surface 3a. To do. By providing such a guide portion 61, the needle member 2 can be rotated and the extending direction A of the needle member 2 can be changed. The extending direction A of the needle member 2 is a direction along the central axis O of the needle member 2. Therefore, with respect to the indwelling device 1, it is possible to reduce the thickness of the portion to be indwelled on the surface of the living body, including the insertion mechanism of the needle member 2, while ensuring the insertion depth of the needle member 2 in the living body. it can.

また、針部材2自体を変形させずに回動させることで、針部材2の延在方向Aを変化させる構成とすれば、針部材自体を変形させて延在方向を変化させる構成と比較して、生体への挿入時または挿入途中において針部材2が折れ曲がり難い構成とすることができる。そのため、針部材2を生体内の所望の位置まで、より確実に挿入することができる。 Further, if the needle member 2 itself is rotated without being deformed to change the extending direction A of the needle member 2, the configuration is compared with a configuration in which the needle member itself is deformed to change the extending direction. Therefore, the needle member 2 can be hard to bend at the time of insertion into the living body or during the insertion. Therefore, the needle member 2 can be more reliably inserted to a desired position in the living body.

ガイド部61は、針部材2に当接し、針部材2の中心軸線Oを含む面内で針部材2を回動させる構成であれば特に限定されない。針部材2の中心軸線Oを含む面内のうち、留置装置1から生体内に向かう方向で、針部材2が回動する。換言すれば、針部材2の中心軸線Oを含む面と、装着面3aとが略直交する面内で、針部材2が回動する。詳細は後述するが、本実施形態のガイド部61は、針部材2が挿通する通路21c1を区画する湾曲面36により構成されている(図5、図6参照)。ガイド部61を含む本実施形態の挿入機構の詳細についても後述する。 The guide portion 61 is not particularly limited as long as it abuts on the needle member 2 and rotates the needle member 2 in a plane including the central axis O of the needle member 2. The needle member 2 rotates in the direction from the indwelling device 1 toward the living body in the plane including the central axis O of the needle member 2. In other words, the needle member 2 rotates in a plane in which the surface including the central axis O of the needle member 2 and the mounting surface 3a are substantially orthogonal to each other. Although details will be described later, the guide portion 61 of the present embodiment is composed of a curved surface 36 for partitioning the passage 21c1 through which the needle member 2 is inserted (see FIGS. 5 and 6). Details of the insertion mechanism of the present embodiment including the guide portion 61 will also be described later.

本実施形態において、上述の「生体表面上に留置される部分」とは、留置装置1の装置本体3を意味する。また、「厚み」とは、生体表面からの突出量を意味する。具体的に、本実施形態の装置本体3の厚みとは、装置本体3の平面状の装着面3aに対して略直交する方向の最大長さを意味する。以下、説明の便宜上、装着面3aに対して略直交する方向を「厚み方向B」と記載する。 In the present embodiment, the above-mentioned "part to be indwelled on the surface of the living body" means the device main body 3 of the indwelling device 1. Further, the "thickness" means the amount of protrusion from the surface of the living body. Specifically, the thickness of the device main body 3 of the present embodiment means the maximum length in a direction substantially orthogonal to the flat mounting surface 3a of the device main body 3. Hereinafter, for convenience of explanation, the direction substantially orthogonal to the mounting surface 3a will be referred to as “thickness direction B”.

また、本実施形態の挿入機構は、上述したガイド部61に加えて、針部材2を所定の一方向に移動させることが可能な移動部62を備える。本実施形態の移動部62は、針部材2を平面状の装着面3aと略平行な所定の一方向に移動させることができる。換言すれば、本実施形態の移動部62は、針部材2を厚み方向Bと略直交する所定の一方向に移動させることができる。 Further, the insertion mechanism of the present embodiment includes, in addition to the guide portion 61 described above, a moving portion 62 capable of moving the needle member 2 in a predetermined direction. The moving portion 62 of the present embodiment can move the needle member 2 in a predetermined direction substantially parallel to the flat mounting surface 3a. In other words, the moving portion 62 of the present embodiment can move the needle member 2 in a predetermined direction substantially orthogonal to the thickness direction B.

本実施形態のガイド部61は、移動部62により移動している針部材2に当接し、中心軸線Oを含む面内で針部材2を回動させ、針部材2の先端の進行方向を所定の一方向から変化させる。このような構成とすることで、針部材2を移動させながら回動させることで、針部材2の先端の進行方向を変化させることができる。そのため、針部材2が回動のみする構成と比較して、生体表面上に留置される部分の厚みを薄肉化しつつ、針部材2の生体内での挿入深さを、より深くすることができる。 The guide portion 61 of the present embodiment abuts on the needle member 2 moving by the moving portion 62, rotates the needle member 2 in a plane including the central axis O, and determines the traveling direction of the tip of the needle member 2. Change from one direction. With such a configuration, the traveling direction of the tip of the needle member 2 can be changed by rotating the needle member 2 while moving it. Therefore, the insertion depth of the needle member 2 in the living body can be made deeper while reducing the thickness of the portion placed on the surface of the living body as compared with the configuration in which the needle member 2 only rotates. ..

より具体的に、本実施形態のガイド部61は、所定の一方向と略直交し、装着面3aに向かう方向に、針部材2の先端の進行方向を変化させる。つまり、本実施形態のガイド部61は、針部材2の先端の進行方向を、装着面3aと略平行する一方向から、装着面3aと略直交する方向(本実施形態では厚み方向Bと同じ方向)へ、と変化させる。このような構成とすれば、生体表面上に留置される部分の厚みを薄肉化しつつ、針部材2の生体内での挿入深さを、より一層、深くすることができる。 More specifically, the guide portion 61 of the present embodiment is substantially orthogonal to a predetermined direction, and changes the traveling direction of the tip of the needle member 2 in the direction toward the mounting surface 3a. That is, in the guide portion 61 of the present embodiment, the traveling direction of the tip of the needle member 2 is from one direction substantially parallel to the mounting surface 3a to a direction substantially orthogonal to the mounting surface 3a (the same as the thickness direction B in the present embodiment). Change to direction). With such a configuration, the insertion depth of the needle member 2 in the living body can be further increased while reducing the thickness of the portion to be placed on the surface of the living body.

移動部62は、針部材2を所定の一方向に移動させることが可能であれば特に限定されない。詳細は後述するが、本実施形態の移動部62は、スライダー24により構成されている(図9A、図9B参照)。また、本実施形態において移動部62が針部材2を移動させる所定の一方向は、スライダー24の直線状の移動方向Cの一方側である、挿入移動方向C1である。移動部62を含む本実施形態の挿入機構の詳細についても後述する。 The moving portion 62 is not particularly limited as long as the needle member 2 can be moved in a predetermined direction. Although details will be described later, the moving portion 62 of the present embodiment is configured by the slider 24 (see FIGS. 9A and 9B). Further, in the present embodiment, the predetermined one direction in which the moving portion 62 moves the needle member 2 is the insertion moving direction C1, which is one side of the linear moving direction C of the slider 24. Details of the insertion mechanism of the present embodiment including the moving portion 62 will also be described later.

以下、本実施形態の留置装置1の更なる詳細について説明する。 Hereinafter, further details of the indwelling device 1 of the present embodiment will be described.

図1〜図6に示す本実施形態の留置装置1は生体情報検出装置である。本実施形態の留置装置1としての生体情報検出装置は、上述した針部材2及び装置本体3の他に、検出部材4を備える。図5、図6に示すように、本実施形態の検出部材4は、針部材2と共に生体内に挿入され、生体内の被計測物質を検出可能である。被検者に装着された状態の、留置装置1としての生体情報検出装置では、生体内に留置された検出部材4による被計測物質の検出結果の情報が、装置本体3に送信される。装置本体3は、受信した検出結果の情報を解析し、必要に応じて、解析結果を表示装置等の外部装置に送信する。留置装置1としての生体情報検出装置は、被検者に装着されている間、被検者の体液中の被計測物質を経時的に計測する。また、留置装置1としての生体情報検出装置が被検者に装着されている期間は、数時間、数日、1週間、1カ月など、医師等の判断で適宜決定される。 The indwelling device 1 of the present embodiment shown in FIGS. 1 to 6 is a biological information detection device. The biological information detection device as the indwelling device 1 of the present embodiment includes the detection member 4 in addition to the needle member 2 and the device main body 3 described above. As shown in FIGS. 5 and 6, the detection member 4 of the present embodiment is inserted into the living body together with the needle member 2 and can detect the substance to be measured in the living body. In the biological information detection device as the indwelling device 1 attached to the subject, information on the detection result of the substance to be measured by the detection member 4 indwelled in the living body is transmitted to the device main body 3. The device main body 3 analyzes the received detection result information, and transmits the analysis result to an external device such as a display device as needed. The biological information detection device as the indwelling device 1 measures the substance to be measured in the body fluid of the subject over time while being worn by the subject. Further, the period during which the biological information detection device as the indwelling device 1 is attached to the subject is appropriately determined by the judgment of a doctor or the like, such as several hours, several days, one week, and one month.

被計測物質は特に限定されない。検出部材は、被計測物質に応じて選択することができる。本実施形態の検出部材4は、間質液中のグルコース、酸素、pH、乳酸等を測定可能である。 The substance to be measured is not particularly limited. The detection member can be selected according to the substance to be measured. The detection member 4 of the present embodiment can measure glucose, oxygen, pH, lactic acid, etc. in the interstitial fluid.

まず、本実施形態の留置装置1としての生体情報検出装置の使用方法について説明する。図7Aは、図2等に示す未使用状態の留置装置1を生体表面BSに装着する装着工程を示す図である。「未使用状態の留置装置1」とは、針部材2及び検出部材4が装置本体3の装着面3aから突出していない状態を意味する。また、図7Aに示す留置装置1の断面は、図5に示す断面と同一である。操作者は、剥離紙(不図示)を剥離することで露出された装置本体3の装着面3aを、生体表面BS上に載置する。上述したように、装着面3aには貼着部が設けられている。そのため、装着面3aを生体表面BSに載置し貼着することで、留置装置1が生体表面BS上に装着される。 First, a method of using the biological information detection device as the indwelling device 1 of the present embodiment will be described. FIG. 7A is a diagram showing a mounting process of mounting the unused indwelling device 1 shown in FIG. 2 and the like on the biological surface BS. The “unused indwelling device 1” means a state in which the needle member 2 and the detection member 4 do not protrude from the mounting surface 3a of the device main body 3. Further, the cross section of the indwelling device 1 shown in FIG. 7A is the same as the cross section shown in FIG. The operator places the mounting surface 3a of the apparatus main body 3 exposed by peeling the release paper (not shown) on the biological surface BS. As described above, the mounting surface 3a is provided with a sticking portion. Therefore, the indwelling device 1 is mounted on the biological surface BS by placing and attaching the mounting surface 3a on the biological surface BS.

図7Bは、図7Aで生体表面BS上に装着された留置装置1を操作することで、針部材2及び検出部材4を生体内に挿入する挿入工程を示す図である。図7Aに示す状態で、後述する操作部材29が押圧される。これにより、図7Bに示すように、針部材2及び検出部材4が、装着面3aから突出する。検出部材4の先端側の部分は、針部材2の内部に収容されている。この突出動作により、針部材2及び検出部材4は、生体内に挿入される。換言すれば、留置装置1は図3、図6に示す状態となる。針部材2及び検出部材4の装着面3aからの突出動作は、上述した装置本体3の挿入機構により実現される。挿入機構の詳細は後述する。 FIG. 7B is a diagram showing an insertion step of inserting the needle member 2 and the detection member 4 into the living body by operating the indwelling device 1 mounted on the living body surface BS in FIG. 7A. In the state shown in FIG. 7A, the operation member 29 described later is pressed. As a result, as shown in FIG. 7B, the needle member 2 and the detection member 4 project from the mounting surface 3a. The portion on the tip end side of the detection member 4 is housed inside the needle member 2. By this protruding operation, the needle member 2 and the detection member 4 are inserted into the living body. In other words, the indwelling device 1 is in the state shown in FIGS. 3 and 6. The protruding operation of the needle member 2 and the detection member 4 from the mounting surface 3a is realized by the insertion mechanism of the device body 3 described above. The details of the insertion mechanism will be described later.

図7Cは、針部材2及び検出部材4を生体内に挿入した後で、検出部材4を生体内に留置したまま、針部材2を生体外に抜去する抜去工程を示す図である。これにより、針部材2は、生体表面BS上に留置されている装置本体3の内部に収容される。その一方で、検出部材4は生体内に留置される。この状態で、例えば1週間などの所定期間に亘って、検出部材4は、後述の通信装置42とともに、被計測物質の継続的な計測に用いられる。 FIG. 7C is a diagram showing a removal step in which the needle member 2 and the detection member 4 are inserted into the living body, and then the needle member 2 is removed from the living body while the detection member 4 is left in the living body. As a result, the needle member 2 is housed inside the device main body 3 indwelled on the biological surface BS. On the other hand, the detection member 4 is placed in the living body. In this state, the detection member 4 is used for continuous measurement of the substance to be measured together with the communication device 42 described later for a predetermined period such as one week.

図7Dは、被計測物質を計測する所定期間が経過した後、留置装置1を生体から取り外す取り外し工程を示す図である。例えば、図7Dに示すように、装置本体3の装着面3aを一端側から他端側に剥がし取るようにして、留置装置1を生体表面BSから取り外す(図7Dの白抜き矢印参照)。この取り外し動作により、検出部材4も生体外に抜去される。 FIG. 7D is a diagram showing a removal step of removing the indwelling device 1 from the living body after a predetermined period for measuring the substance to be measured has elapsed. For example, as shown in FIG. 7D, the indwelling device 1 is removed from the biological surface BS by peeling off the mounting surface 3a of the device main body 3 from one end side to the other end side (see the white arrow in FIG. 7D). By this removal operation, the detection member 4 is also removed from the living body.

以下、本実施形態の留置装置1としての生体情報検出装置の各部の詳細について説明する。 Hereinafter, details of each part of the biological information detection device as the indwelling device 1 of the present embodiment will be described.

図8は、図2等に示す未使用状態の留置装置1を分解した分解斜視図である。図8に示すように、本実施形態の留置装置1は、ベース部材11と、カバー部材12と、を備えている。換言すれば、ベース部材11に対してカバー部材12を取り付けることで、留置装置1が形成されている。詳細は後述するが、本実施形態の針部材2及び検出部材4は、ベース部材11に含まれている(図10参照)。また、本実施形態の装置本体3は、ベース部材11の針部材2及び検出部材4以外の部分、及び、カバー部材12の全部、により構成されている。更に、本実施形態の装置本体3の挿入機構は、ベース部材11に含まれている。図9A及び図9Bは、ベース部材11を分解した分解斜視図である。図10は、図8に示すベース部材11及びカバー部材12それぞれの断面図である。図10に示す断面は、図5及び図6に示す断面と同位置での断面である。 FIG. 8 is an exploded perspective view of the unused indwelling device 1 shown in FIG. 2 and the like. As shown in FIG. 8, the indwelling device 1 of the present embodiment includes a base member 11 and a cover member 12. In other words, the indwelling device 1 is formed by attaching the cover member 12 to the base member 11. Although details will be described later, the needle member 2 and the detection member 4 of the present embodiment are included in the base member 11 (see FIG. 10). Further, the apparatus main body 3 of the present embodiment is composed of a portion of the base member 11 other than the needle member 2 and the detection member 4, and the entire cover member 12. Further, the insertion mechanism of the apparatus main body 3 of the present embodiment is included in the base member 11. 9A and 9B are exploded perspective views of the base member 11. FIG. 10 is a cross-sectional view of each of the base member 11 and the cover member 12 shown in FIG. The cross section shown in FIG. 10 is a cross section at the same position as the cross section shown in FIGS. 5 and 6.

まず、主に図8〜図10を参照して、本実施形態の留置装置1としての生体情報検出装置のベース部材11及びカバー部材12それぞれの詳細について説明する。ここでは、特に説明しない限り、図2、図5等に示す未使用状態の留置装置1を構成するベース部材11及びカバー部材12について説明する。 First, details of each of the base member 11 and the cover member 12 of the biological information detection device as the indwelling device 1 of the present embodiment will be described mainly with reference to FIGS. 8 to 10. Here, unless otherwise specified, the base member 11 and the cover member 12 constituting the unused indwelling device 1 shown in FIGS. 2, 5 and the like will be described.

<ベース部材11>
図8〜図10に示すように、本実施形態のベース部材11は、針部材2、検出部材4、台座部材21、台座カバー部材22、駆動装置23、スライダー24、針保持部材25、支持部材26、駆動制御部材27、回路基板28、及び、操作部材29、を備える。図9Aは、ベース部材11を、台座カバー部材22と、それ以外と、に分解した分解斜視図である。図9Bは、ベース部材11を、台座カバー部材22と、針部材2、検出部材4、スライダー24、針保持部材25及び支持部材26を含む部材群と、駆動装置23と、台座部材21、駆動制御部材27、回路基板28及び操作部材29を含む部材群と、の4つの部分に分解した分解斜視図である。
<Base member 11>
As shown in FIGS. 8 to 10, the base member 11 of the present embodiment includes a needle member 2, a detection member 4, a pedestal member 21, a pedestal cover member 22, a drive device 23, a slider 24, a needle holding member 25, and a support member. 26, a drive control member 27, a circuit board 28, and an operation member 29. FIG. 9A is an exploded perspective view of the base member 11 disassembled into a pedestal cover member 22 and the rest. FIG. 9B shows the base member 11 as a member group including a pedestal cover member 22, a needle member 2, a detection member 4, a slider 24, a needle holding member 25 and a support member 26, a driving device 23, a pedestal member 21, and a drive. It is an exploded perspective view disassembled into four parts of a member group including a control member 27, a circuit board 28 and an operation member 29.

[針部材2]
図10に示すように、針部材2は検出部材4を内部に収容しており、検出部材4と共に生体内に挿入される。針部材2の先端部には刃面が形成されている。また、針部材2は、検出部材4と比較して折れ曲がり難い。そのため、針部材2内に検出部材4を収容した状態で針部材2を生体内に挿入することで、検出部材4を生体内に容易に挿入することができる。
[Needle member 2]
As shown in FIG. 10, the needle member 2 houses the detection member 4 inside, and is inserted into the living body together with the detection member 4. A blade surface is formed at the tip of the needle member 2. Further, the needle member 2 is less likely to bend than the detection member 4. Therefore, the detection member 4 can be easily inserted into the living body by inserting the needle member 2 into the living body with the detecting member 4 housed in the needle member 2.

本実施形態の針部材2は、上述したように、検出部材4と共に生体内に挿入された後で、検出部材4を生体内に留置したまま、生体外に抜去される。図11は、針部材2、検出部材4、針保持部材25及び支持部材26のみを示す図である。図11に示すように、本実施形態の針部材2は、延在方向Aに直交する断面で、周方向の一部に間隙が形成されているU字針である。換言すれば、本実施形態の針部材2には、針部材2の延在方向Aに沿って延びるスリット開口2aが形成されている。針部材2を生体外に抜去する際に、検出部材4は、スリット開口2aを通じて、針部材2の内部から外部に抜け出ることができる。 As described above, the needle member 2 of the present embodiment is inserted into the living body together with the detecting member 4, and then removed from the living body while the detection member 4 is left in the living body. FIG. 11 is a diagram showing only the needle member 2, the detection member 4, the needle holding member 25, and the support member 26. As shown in FIG. 11, the needle member 2 of the present embodiment is a U-shaped needle having a cross section orthogonal to the extending direction A and having a gap formed in a part in the circumferential direction. In other words, the needle member 2 of the present embodiment is formed with a slit opening 2a extending along the extending direction A of the needle member 2. When the needle member 2 is removed from the living body, the detection member 4 can escape from the inside of the needle member 2 to the outside through the slit opening 2a.

また、図10等に示すように、本実施形態の針部材2は、円弧状に湾曲して延在する円弧針である。本実施形態の針部材2は、後述する円柱状の針保持部材25に基端を支持されており、針保持部材25から厚み方向Bと略直交する方向に延在し、先端に向かうにつれて厚み方向Bで装着面3aに近づく方向に円弧状に湾曲している。 Further, as shown in FIG. 10 and the like, the needle member 2 of the present embodiment is an arc needle that is curved and extends in an arc shape. The needle member 2 of the present embodiment has a base end supported by a columnar needle holding member 25 described later, extends from the needle holding member 25 in a direction substantially orthogonal to the thickness direction B, and becomes thicker toward the tip. It is curved in an arc shape in the direction B toward the mounting surface 3a.

図5、図6に示すように、本実施形態の針部材2の進行方向は、針部材2の挿入時に変化する。より具体的に、本実施形態の針部材2は、装着面3aから突出させる生体への挿入時に、針部材2の厚み方向Bにおける長さが最も長くなるように、中心軸線Oを全て含む平面内で回動することで、延在方向Aを変化させる。 As shown in FIGS. 5 and 6, the traveling direction of the needle member 2 of the present embodiment changes when the needle member 2 is inserted. More specifically, the needle member 2 of the present embodiment is a plane including all the central axis O so that the length of the needle member 2 in the thickness direction B becomes the longest when the needle member 2 is inserted into a living body protruding from the mounting surface 3a. By rotating inside, the extending direction A is changed.

上述したスリット開口2a(図11参照)は、円弧状に湾曲する針部材2の周壁のうち、装着面3a側の部分(図10の下側の部分)に形成されている。 The slit opening 2a (see FIG. 11) described above is formed on a portion (lower portion of FIG. 10) on the mounting surface 3a side of the peripheral wall of the needle member 2 that is curved in an arc shape.

針部材2の太さは、例えば、最大外径が0.2mm〜1.2mm(33〜18ゲージの外径に相当)である。針部材2の長さは、1mm〜10mm、好ましくは3〜6mmである。また、針部材2の肉厚は、0.02mm〜0.15mmの範囲から設定される。 The thickness of the needle member 2 is, for example, a maximum outer diameter of 0.2 mm to 1.2 mm (corresponding to an outer diameter of 33 to 18 gauge). The length of the needle member 2 is 1 mm to 10 mm, preferably 3 to 6 mm. The wall thickness of the needle member 2 is set in the range of 0.02 mm to 0.15 mm.

針部材2の材料としては、例えば、ステンレス鋼、アルミニウム、アルミニウム合金、チタン、チタン合金等の金属材料が用いられる。 As the material of the needle member 2, for example, a metal material such as stainless steel, aluminum, aluminum alloy, titanium, or titanium alloy is used.

また、詳細は後述するが、本実施形態の針部材2は、移動部62としてのスライダー24により、所定の一方向としての挿入移動方向C1に移動可能である。本実施形態の針部材2の基端部は、針部材2が上記移動をしているときに、移動部62に対して、所定の一方向と直交する方向としての厚み方向Bに、移動可能である。 Further, as will be described in detail later, the needle member 2 of the present embodiment can be moved in the insertion moving direction C1 as a predetermined one direction by the slider 24 as the moving portion 62. The base end portion of the needle member 2 of the present embodiment can move in the thickness direction B as a direction orthogonal to a predetermined one direction with respect to the moving portion 62 when the needle member 2 is moving. Is.

[検出部材4]
図10に示すように、検出部材4は、針部材2の延在方向Aに沿って、針部材2内に延在する線状のワイヤ電極を備える。図11に示すように、本実施形態の検出部材4は、針部材2内に配置された3本の電極(作用電極50a、参照電極50b、対極50c)から構成されている。作用電極50aは、延在方向Aに延びる導電層を有する芯材と、この芯材の外壁上に、検体と接触して被計測物質を検出するよう構成された検出部と、干渉物質の透過を制限する保護部と、絶縁性の素材でコーティングされた絶縁部と、を備える。検出部により、被計測物質に対する電気的特性の変化を検出することができる。検出部は、芯材表面にスプレーコート、ディッピング、電解重合、スパッタリング等の薄膜形成手段を用いて形成される。検出部材4は、針部材2内に複数配置されてもよい。検出部材4は、被計測物質の測定方法によって適宜選択され、針部材2内に配置される電極の数も特に限定されない。
[Detection member 4]
As shown in FIG. 10, the detection member 4 includes a linear wire electrode extending in the needle member 2 along the extending direction A of the needle member 2. As shown in FIG. 11, the detection member 4 of the present embodiment is composed of three electrodes (working electrode 50a, reference electrode 50b, counter electrode 50c) arranged in the needle member 2. The working electrode 50a has a core material having a conductive layer extending in the extending direction A, a detection unit configured to detect a substance to be measured in contact with a sample on the outer wall of the core material, and transmission of an interfering substance. It is provided with a protective part for limiting the amount of the material and an insulating part coated with an insulating material. The detection unit can detect changes in electrical characteristics with respect to the substance to be measured. The detection unit is formed on the surface of the core material by using a thin film forming means such as spray coating, dipping, electrolytic polymerization, and sputtering. A plurality of detection members 4 may be arranged in the needle member 2. The detection member 4 is appropriately selected depending on the method for measuring the substance to be measured, and the number of electrodes arranged in the needle member 2 is not particularly limited.

検出部材4は、後述する回路基板28(図10等参照)に形成されている電気回路と接続されている。具体的に、本実施形態の検出部材4の基端側は、針部材2のスリット開口2aを通じて、針部材2外に延在しており、回路基板28に形成されている電気回路の後述する第1電気接点部28a(図9A参照)に接続されている。検出部材4が生体内で検出する被計測物質の量に対応した電気的信号が、回路基板28上の電気回路を通じて、後述するカバー部材12の通信装置42へ送信される。 The detection member 4 is connected to an electric circuit formed on a circuit board 28 (see FIG. 10 and the like) described later. Specifically, the proximal end side of the detection member 4 of the present embodiment extends outside the needle member 2 through the slit opening 2a of the needle member 2, and the electric circuit formed on the circuit board 28 will be described later. It is connected to the first electrical contact portion 28a (see FIG. 9A). An electric signal corresponding to the amount of the substance to be measured detected by the detection member 4 in the living body is transmitted to the communication device 42 of the cover member 12 described later through the electric circuit on the circuit board 28.

より具体的に、本実施形態の検出部材4は、針部材2の内部で針部材2の延在方向Aに沿って延在する先端側部4aと、この先端側部4aから屈曲し、先端側部4aの延在方向とは異なる方向に延在する基端側部4bと、を備える。基端側部4bは、スリット開口2aを通じて、針部材2の外部に延在している。また、基端側部4bは、後述する針保持部材25及び支持部材26の間を延在し、導線37(図9A参照。図9A、図13及び図14、以外では図示省略)を介して、回路基板28に形成されている電気回路の第1電気接点部28a(図9A参照)と接続されている。 More specifically, the detection member 4 of the present embodiment has a tip side portion 4a extending inside the needle member 2 along the extending direction A of the needle member 2 and a tip end portion 4a bent from the tip end side portion 4a. A base end side portion 4b extending in a direction different from the extending direction of the side portion 4a is provided. The base end side portion 4b extends to the outside of the needle member 2 through the slit opening 2a. Further, the base end side portion 4b extends between the needle holding member 25 and the support member 26, which will be described later, via a lead wire 37 (see FIG. 9A; not shown except for FIGS. 9A, 13 and 14). , Is connected to the first electric contact portion 28a (see FIG. 9A) of the electric circuit formed on the circuit board 28.

検出部材4を構成する各電極の外径は0.02mm〜0.2mmが好ましい。検出部材4を構成する各電極の外径が大きくなると生体内への挿入時の侵襲が大きくなる。 The outer diameter of each electrode constituting the detection member 4 is preferably 0.02 mm to 0.2 mm. As the outer diameter of each electrode constituting the detection member 4 becomes larger, the invasion at the time of insertion into the living body becomes larger.

[台座部材21]
図8〜図10に示すように、本実施形態の台座部材21は、底板部21aと、側板部21bと、を備える。底板部21aは、オーバル状の外縁を有する。側板部21bは、この底板部21aの外縁から底板部21aの厚み方向(本実施形態では厚み方向Bと同じ方向)の一方側に連続して突出している。底板部21aの厚み方向の一方側の面には、後述する駆動装置23、スライダー24等を含む挿入機構が取り付けられている。底板部21aの厚み方向の他方側の面は、留置装置1の装置本体3の装着面3aを構成する。装着面3aには、上述したように、生体に貼着するための貼着部が設けられている。以下、説明の便宜上、装着面3aを構成する底板部21aの厚み方向の他方側の面を「生体接触面」と記載し、生体接触面と反対側の面である、底板部21aの厚み方向の一方側の面を「取付面」と記載する。
[Pedestal member 21]
As shown in FIGS. 8 to 10, the pedestal member 21 of the present embodiment includes a bottom plate portion 21a and a side plate portion 21b. The bottom plate portion 21a has an oval-shaped outer edge. The side plate portion 21b continuously protrudes from the outer edge of the bottom plate portion 21a to one side in the thickness direction of the bottom plate portion 21a (in the present embodiment, the same direction as the thickness direction B). An insertion mechanism including a drive device 23, a slider 24, and the like, which will be described later, is attached to one surface of the bottom plate portion 21a in the thickness direction. The surface of the bottom plate portion 21a on the other side in the thickness direction constitutes the mounting surface 3a of the device main body 3 of the indwelling device 1. As described above, the mounting surface 3a is provided with a sticking portion for sticking to a living body. Hereinafter, for convenience of explanation, the surface on the other side of the bottom plate portion 21a constituting the mounting surface 3a in the thickness direction is referred to as a “biological contact surface”, and is the surface opposite to the biological contact surface in the thickness direction of the bottom plate portion 21a. One surface is referred to as the "mounting surface".

底板部21aの取付面側で、側板部21bに囲まれる空間には、針部材2、検出部材4、駆動装置23、スライダー24、針保持部材25、支持部材26、駆動制御部材27、及び、回路基板28、が配置されている。また、底板部21aの取付面側で、側板部21bに囲まれる空間は、台座カバー部材22により覆われている。図10に示すように、側板部21bの周方向の一部には開口部21b1が形成されている。後述する操作部材29は、この開口部21b1を通じて、側板部21bの内側から外側に突出している。 In the space surrounded by the side plate portion 21b on the mounting surface side of the bottom plate portion 21a, the needle member 2, the detection member 4, the drive device 23, the slider 24, the needle holding member 25, the support member 26, the drive control member 27, and the like. The circuit board 28 is arranged. Further, the space surrounded by the side plate portion 21b on the mounting surface side of the bottom plate portion 21a is covered with the pedestal cover member 22. As shown in FIG. 10, an opening 21b1 is formed in a part of the side plate portion 21b in the circumferential direction. The operation member 29, which will be described later, projects from the inside to the outside of the side plate portion 21b through the opening 21b1.

図9及び図10に示すように、台座部材21は、底板部21aの取付面から厚み方向の一方側に突出する突出部21cを更に備える。図10に示すように、この突出部21cには、側板部21bに囲まれている空間から底板部21aの生体接触面により構成される装着面3aまで通じる、針部材2が挿通可能な通路21c1が形成されている。この通路21c1を区画する内壁は、針部材2の中心軸線Oを含む断面(図10参照)において円弧状に延在する湾曲面36を備える。針部材2は、この湾曲面36に当接しながら、通路21c1に沿って移動可能である。この円弧状の湾曲面36は、厚み方向Bにおいて、移動部62としての後述するスライダー24の挿入移動方向C1に向かうにつれて、装着面3aに近づくように延在している。本実施形態のガイド部61は、上述の湾曲面36により構成されている。 As shown in FIGS. 9 and 10, the pedestal member 21 further includes a protruding portion 21c protruding from the mounting surface of the bottom plate portion 21a to one side in the thickness direction. As shown in FIG. 10, the protrusion 21c has a passage 21c1 through which the needle member 2 can be inserted, which leads from the space surrounded by the side plate 21b to the mounting surface 3a formed by the biological contact surface of the bottom plate 21a. Is formed. The inner wall that partitions the passage 21c1 includes a curved surface 36 that extends in an arc shape in a cross section (see FIG. 10) including the central axis O of the needle member 2. The needle member 2 can move along the passage 21c1 while abutting on the curved surface 36. The arc-shaped curved surface 36 extends so as to approach the mounting surface 3a in the thickness direction B toward the insertion movement direction C1 of the slider 24 described later as the moving portion 62. The guide portion 61 of the present embodiment is composed of the curved surface 36 described above.

また、図9A、図9Bに示すように、突出部21cの外面には係合凹部21c2が形成されている。この係合凹部21c2は、後述する支持部材26の係合凸部35(図11参照)と嵌合する。台座部材21は、係合凹部21c2に係合凸部35を嵌合させることで、後述する支持部材26を係止することができる。この詳細は後述する。 Further, as shown in FIGS. 9A and 9B, an engaging recess 21c2 is formed on the outer surface of the protruding portion 21c. The engaging recess 21c2 fits with the engaging convex portion 35 (see FIG. 11) of the support member 26 described later. The pedestal member 21 can lock the support member 26 described later by fitting the engaging convex portion 35 into the engaging concave portion 21c2. The details will be described later.

図9Bに示すように、底板部21aの取付面には、複数(本実施形態では2つ)の係止凸部21a1と、回動軸部21a2と、が設けられている。複数の係止凸部21a1は、後述する駆動装置23の固定部23aに挿通され、固定部23aの台座部材21に対する位置を固定する。回動軸部21a2は、後述する駆動装置23の回動部23b(図9B等参照)に挿通される。つまり、本実施形態の回動部23bは、回動軸部21a2の軸周りを回動可能に、台座部材21に対して取り付けられている。 As shown in FIG. 9B, a plurality of (two in this embodiment) locking convex portions 21a1 and a rotating shaft portion 21a2 are provided on the mounting surface of the bottom plate portion 21a. The plurality of locking convex portions 21a1 are inserted into the fixing portion 23a of the drive device 23 described later to fix the position of the fixing portion 23a with respect to the pedestal member 21. The rotating shaft portion 21a2 is inserted into the rotating portion 23b (see FIG. 9B and the like) of the drive device 23 described later. That is, the rotating portion 23b of the present embodiment is attached to the pedestal member 21 so as to be rotatable around the axis of the rotating shaft portion 21a2.

更に、図9Bに示すように、底板部21aの取付面には、回動制御凸部21a3が設けられている。回動制御凸部21a3は、後述する回動部23bの下面に形成されている弧状の長孔23b3(図12参照)に入り込む。回動制御凸部21a3は、台座部材21に対する回動部23bの回動方向、及び、回動範囲、を制限する。 Further, as shown in FIG. 9B, a rotation control convex portion 21a3 is provided on the mounting surface of the bottom plate portion 21a. The rotation control convex portion 21a3 enters the arc-shaped elongated hole 23b3 (see FIG. 12) formed on the lower surface of the rotation portion 23b described later. The rotation control convex portion 21a3 limits the rotation direction and rotation range of the rotation portion 23b with respect to the pedestal member 21.

また、図9A、図9Bに示すように、台座部材21の側板部21bの外面に沿って外面凸部21b2が設けられている。外面凸部21b2は、ベース部材11に対してカバー部材12を取り付ける際に、カバー部材12のハウジング44に形成されている内面凹部44b2(図8、図10参照)に嵌合する。これにより、ベース部材11に対してカバー部材12を係止することができる。 Further, as shown in FIGS. 9A and 9B, an outer surface convex portion 21b2 is provided along the outer surface of the side plate portion 21b of the pedestal member 21. When the cover member 12 is attached to the base member 11, the outer surface convex portion 21b2 fits into the inner surface concave portion 44b2 (see FIGS. 8 and 10) formed in the housing 44 of the cover member 12. As a result, the cover member 12 can be locked to the base member 11.

図9A、図9Bに示すように、側板部21bの内面には、後述するスライダー24の直線方向の移動をガイドする当接ガイド部21b3が設けられている。スライダー24は、当接ガイド部21b3と当接することで、直線状の移動方向Cに移動可能である。 As shown in FIGS. 9A and 9B, a contact guide portion 21b3 for guiding the movement of the slider 24 in the linear direction, which will be described later, is provided on the inner surface of the side plate portion 21b. The slider 24 can move in the linear moving direction C by coming into contact with the contact guide portion 21b3.

図8〜図10に示すように、台座部材21の側板部21bの先端面には、環状シール部材33が取り付けられている。環状シール部材33は、台座部材21と後述する台座カバー部材22との間をシールし、かつ、台座部材21とカバー部材12のハウジング44との間をシールする。環状シール部材33は、例えば、ゴムやエラストマ等の弾性を有する材料により形成することができる。また、環状シール部材33は、例えば二色成形などで、側板部21bの先端面に一体に成形することができる。 As shown in FIGS. 8 to 10, an annular seal member 33 is attached to the tip surface of the side plate portion 21b of the pedestal member 21. The annular seal member 33 seals between the pedestal member 21 and the pedestal cover member 22, which will be described later, and seals between the pedestal member 21 and the housing 44 of the cover member 12. The annular seal member 33 can be formed of, for example, an elastic material such as rubber or an elastomer. Further, the annular seal member 33 can be integrally molded on the tip surface of the side plate portion 21b by, for example, two-color molding.

台座部材21の材料としては、例えば樹脂材料が挙げられる。この樹脂材料としては、例えば、ABS樹脂、AS樹脂、ポリエチレン、ポリプロピレン、ポリスチレン、ポリ塩化ビニル、ポリ塩化ビニリデン樹脂、ポリフェニレンオキサイド、熱可塑性ポリウレタン、ポリメチレンメタクリレート、ポリオキシエチレン、フッ素樹脂、ポリカーボネート、ポリアミド、アセタール樹脂、アクリル樹脂、ポリエチレンテレフタレート等の射出成形で用いられる熱可塑性樹脂や、フェノール樹脂、エポキシ樹脂、シリコーン樹脂、不飽和ポリエステル等の熱硬化性樹脂等が挙げられる。 Examples of the material of the pedestal member 21 include a resin material. Examples of the resin material include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, and polyamide. , Acetal resin, acrylic resin, thermoplastic resin used in injection molding such as polyethylene terephthalate, and thermosetting resin such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.

[台座カバー部材22]
図8、図10に示すように、台座カバー部材22は、台座部材21の底板部21aの取付面との間に内部空間Xを保持した状態で、台座部材21を覆う。台座部材21と台座カバー部材22との間の内部空間Xには、上述したように、針部材2、検出部材4、駆動装置23、スライダー24、針保持部材25、支持部材26、駆動制御部材27、及び、回路基板28、が収容される。詳細は後述するが、針部材2及び検出部材4は、挿入機構により移動可能である。針部材2及び検出部材4は、台座部材21の通路21c1を通じて、装置本体3(図5等参照)の装着面3aとしての、台座部材21の底板部21aの生体接触面から突出可能である。また、底板部21aの生体接触面から突出した針部材2は、検出部材4を、底板部21aの生体接触面から突出した状態としたまま、台座部材21の通路21c1を通じて、内部空間Xに収容可能である。針部材2及び検出部材4の上述の動作を実現する構成の詳細は後述する。
[Pedestal cover member 22]
As shown in FIGS. 8 and 10, the pedestal cover member 22 covers the pedestal member 21 in a state where the internal space X is held between the pedestal member 21 and the mounting surface of the bottom plate portion 21a. In the internal space X between the pedestal member 21 and the pedestal cover member 22, as described above, the needle member 2, the detection member 4, the drive device 23, the slider 24, the needle holding member 25, the support member 26, and the drive control member 27 and the circuit board 28 are accommodated. Although the details will be described later, the needle member 2 and the detection member 4 can be moved by the insertion mechanism. The needle member 2 and the detection member 4 can project from the biological contact surface of the bottom plate portion 21a of the pedestal member 21 as the mounting surface 3a of the device main body 3 (see FIG. 5 and the like) through the passage 21c1 of the pedestal member 21. Further, the needle member 2 protruding from the biological contact surface of the bottom plate portion 21a is housed in the internal space X through the passage 21c1 of the pedestal member 21 with the detection member 4 protruding from the biological contact surface of the bottom plate portion 21a. It is possible. Details of the configuration for realizing the above-mentioned operations of the needle member 2 and the detection member 4 will be described later.

台座カバー部材22の材料としては、例えば、台座部材21の材料として例示した上述の材料と同一の材料を用いることができる。 As the material of the pedestal cover member 22, for example, the same material as the above-mentioned material exemplified as the material of the pedestal member 21 can be used.

[駆動装置23]
図9、図10に示すように、駆動装置23は、固定部23aと、回動部23bと、を備える。
[Drive device 23]
As shown in FIGS. 9 and 10, the drive device 23 includes a fixing portion 23a and a rotating portion 23b.

固定部23aは動力磁極部23a1を有する。本実施形態の固定部23aは、台座部材21の底板部21aに設けられた複数の係止凸部21a1が挿通されることで、台座部材21に対して位置が固定されている。本実施形態の固定部23aは、永久磁石により構成されている。また、本実施形態の固定部23aは、後述する回動部23bと対向する位置に、動力磁極部23a1としてのN極部を備える。 The fixed portion 23a has a power magnetic pole portion 23a1. The position of the fixing portion 23a of the present embodiment is fixed with respect to the pedestal member 21 by inserting a plurality of locking convex portions 21a1 provided on the bottom plate portion 21a of the pedestal member 21. The fixing portion 23a of the present embodiment is composed of a permanent magnet. Further, the fixed portion 23a of the present embodiment includes an N pole portion as the power magnetic pole portion 23a1 at a position facing the rotating portion 23b described later.

図9Bに示すように、回動部23bは、固定部23aの動力磁極部23a1と同一の磁極を有する第1磁極部23b1と、固定部23aの動力磁極部23a1と異なる磁極を有する第2磁極部23b2と、を備える。本実施形態の回動部23bは、台座部材21に対して回動可能に取り付けられている。具体的に、本実施形態の回動部23bは、台座部材21の底板部21aに設けられた回動軸部21a2が挿通されている状態で、回動軸部21a2の軸回りを回動可能である。また、本実施形態の回動部23bは、永久磁石により構成されており、第1磁極部23b1としてのN極部と、第2磁極部23b2としてのS極部と、を備える。 As shown in FIG. 9B, the rotating portion 23b has a first magnetic pole portion 23b1 having the same magnetic pole as the power magnetic pole portion 23a1 of the fixed portion 23a, and a second magnetic pole having a magnetic pole different from that of the power magnetic pole portion 23a1 of the fixed portion 23a. A unit 23b2 and the like. The rotating portion 23b of the present embodiment is rotatably attached to the pedestal member 21. Specifically, the rotating portion 23b of the present embodiment can rotate around the axis of the rotating shaft portion 21a2 in a state where the rotating shaft portion 21a2 provided in the bottom plate portion 21a of the pedestal member 21 is inserted. Is. Further, the rotating portion 23b of the present embodiment is composed of a permanent magnet, and includes an N pole portion as the first magnetic pole portion 23b1 and an S pole portion as the second magnetic pole portion 23b2.

固定部23aの動力磁極部23a1としてのN極部に対して、回動部23bの第1磁極部23b1としてのN極部を近接させれば、同極同士の斥力の磁力により、回動部23bを、台座部材21の回動軸部21a2の軸回りに回動させることができる。逆に、固定部23aの動力磁極部23a1としてのN極部に対して、回動部23bの第2磁極部23b2としてのS極部を近接させれば、異極同士の引力の磁力により、回動部23bは、回動軸部21a2の軸回りに回動しない。つまり、固定部23aの動力磁極部23a1としてのN極部と、回動部23bの第2磁極部23b2としてのS極部と、が近接して配置された状態を維持することができる。 If the N-pole portion as the first magnetic pole portion 23b1 of the rotating portion 23b is brought close to the N-pole portion as the power magnetic pole portion 23a1 of the fixed portion 23a, the rotating portion is caused by the magnetic force of the repulsive force between the same poles. The 23b can be rotated around the axis of the rotation shaft portion 21a2 of the pedestal member 21. On the contrary, if the S pole portion as the second magnetic pole portion 23b2 of the rotating portion 23b is brought close to the N pole portion as the power magnetic pole portion 23a1 of the fixed portion 23a, the magnetic force of the attractive force between the different poles causes. The rotating portion 23b does not rotate around the axis of the rotating shaft portion 21a2. That is, it is possible to maintain a state in which the N pole portion of the fixed portion 23a as the power magnetic pole portion 23a1 and the S pole portion of the rotating portion 23b as the second magnetic pole portion 23b2 are arranged close to each other.

本実施形態の回動部23bは、中央位置に回動軸部21a2が挿通可能な貫通孔が形成されている略円盤状の外形を有している。また、本実施形態の回動部23bは、第1磁極部23b1及び第2磁極部23b2のみで構成されている。より具体的に、本実施形態の回動部23bは、半円状の第1磁極部23b1と、半円状の第2磁極部23b2と、により構成されている。また、本実施形態の固定部23aの外面には、回動部23bの外周面に沿って延在する湾曲部23a2が設けられている。すなわち、固定部23aの外周面の少なくとも一部は、回動部23bの外周面に沿った形状である。この湾曲部23a2は、動力磁極部23a1としてのN極部に形成されている。このように、動力磁極部23a1としてのN極部に湾曲部23a2を形成することで、動力磁極部23a1を、回動部23bに近接配置し易くなる。 The rotating portion 23b of the present embodiment has a substantially disk-shaped outer shape in which a through hole through which the rotating shaft portion 21a2 can be inserted is formed at the center position. Further, the rotating portion 23b of the present embodiment is composed of only the first magnetic pole portion 23b1 and the second magnetic pole portion 23b2. More specifically, the rotating portion 23b of the present embodiment is composed of a semicircular first magnetic pole portion 23b1 and a semicircular second magnetic pole portion 23b2. Further, on the outer surface of the fixed portion 23a of the present embodiment, a curved portion 23a2 extending along the outer peripheral surface of the rotating portion 23b is provided. That is, at least a part of the outer peripheral surface of the fixed portion 23a has a shape along the outer peripheral surface of the rotating portion 23b. The curved portion 23a2 is formed in the N pole portion as the power magnetic pole portion 23a1. By forming the curved portion 23a2 on the north pole portion as the power magnetic pole portion 23a1 in this way, the power magnetic pole portion 23a1 can be easily arranged close to the rotating portion 23b.

図12は、本実施形態の回動部23bのうち、台座部材21の底板部21a(図9B等参照)の取付面と対向する下面を示す図である。図12に示すように、回動部23bの下面には、回動部23bの回動方向に沿って円弧状に延在する長孔23b3が形成されている。この長孔23b3には、上述の台座部材21の回動制御凸部21a3(図9B参照)が入り込む。回動部23bが台座部材21に対して回動すると、長孔23b3内での回動制御凸部21a3の相対的な位置が変化する。そして、回動制御凸部21a3が、長孔23b3の弧状に延在する延在方向の両端の壁(起点と終点)に突き当たることで、回動部23bのそれ以上の回動が規制される。 FIG. 12 is a diagram showing a lower surface of the rotating portion 23b of the present embodiment facing the mounting surface of the bottom plate portion 21a (see FIG. 9B and the like) of the pedestal member 21. As shown in FIG. 12, an elongated hole 23b3 extending in an arc shape along the rotation direction of the rotating portion 23b is formed on the lower surface of the rotating portion 23b. The rotation control convex portion 21a3 (see FIG. 9B) of the pedestal member 21 described above is inserted into the elongated hole 23b3. When the rotating portion 23b rotates with respect to the pedestal member 21, the relative position of the rotation control convex portion 21a3 in the elongated hole 23b3 changes. Then, the rotation control convex portion 21a3 abuts on the walls (starting point and ending point) at both ends in the extending direction extending in an arc shape of the elongated hole 23b3, so that further rotation of the rotating portion 23b is restricted. ..

また、図12に示すように、回動部23bは外周面の周方向の一部には、段差部23b4が形成されており、この段差部23b4には、周方向に対向する係合壁部31が形成せれている。この係合壁部31は、回動方向と同じ方向に向いた切欠き面により構成されている。係合壁部31は、後述する駆動制御部材27と当接することで、未使用状態の留置装置1において、駆動装置23の回動部23bが意図せずに回動することを抑制することができる。これにより、図2等に示す未使用状態の留置装置1において、針部材2及び検出部材4が、意図せずに装着面3aから飛び出すことを抑制することができる。駆動制御部材27の詳細は後述する。 Further, as shown in FIG. 12, the rotating portion 23b has a stepped portion 23b4 formed on a part of the outer peripheral surface in the circumferential direction, and the stepped portion 23b4 has an engaging wall portion facing the circumferential direction. 31 is formed. The engaging wall portion 31 is composed of a notch surface facing in the same direction as the rotation direction. By abutting the engaging wall portion 31 with the drive control member 27 described later, it is possible to prevent the rotating portion 23b of the drive device 23 from unintentionally rotating in the indwelling device 1 in the unused state. it can. As a result, in the unused indwelling device 1 shown in FIG. 2 and the like, it is possible to prevent the needle member 2 and the detection member 4 from unintentionally jumping out from the mounting surface 3a. Details of the drive control member 27 will be described later.

更に、図9A、図9Bに示すように、回動部23bには、後述するスライダー24と係合する係合軸部23b5が形成されている。本実施形態の係合軸部23b5は、回動部23bの下面とは反対側の上面に形成されている。また、係合軸部23b5は、回動軸部21a2の位置とは異なる位置、すなわち、回動部23bの回動中心から離れた位置、に形成されている。そのため、回動部23bが回動すると、回動部23bの回動平面内において、係合軸部23b5の位置も移動方向Cに移動する。後述するスライダー24は、この係合軸部23b5の移動に伴って移動方向Cに移動することができる。 Further, as shown in FIGS. 9A and 9B, the rotating portion 23b is formed with an engaging shaft portion 23b5 that engages with the slider 24 described later. The engaging shaft portion 23b5 of the present embodiment is formed on the upper surface opposite to the lower surface of the rotating portion 23b. Further, the engaging shaft portion 23b5 is formed at a position different from the position of the rotating shaft portion 21a2, that is, a position away from the rotation center of the rotating portion 23b. Therefore, when the rotating portion 23b rotates, the position of the engaging shaft portion 23b5 also moves in the moving direction C in the rotating plane of the rotating portion 23b. The slider 24, which will be described later, can move in the moving direction C as the engaging shaft portion 23b5 moves.

本実施形態の固定部23aは、動力磁極部23a1としてのN極部を備えるが、この構成に限らず、S極部により動力磁極部23a1を構成してもよい。かかる場合には、固定部23aの動力磁極部23a1と同一の磁極を有する第1磁極部23b1をS極部とし、固定部23aの動力磁極部23a1と異なる磁極を有する第2磁極部23b2をN極部とする。 The fixed portion 23a of the present embodiment includes an N-pole portion as the power magnetic pole portion 23a1, but the present invention is not limited to this configuration, and the power magnetic pole portion 23a1 may be configured by the S-pole portion. In such a case, the first magnetic pole portion 23b1 having the same magnetic pole as the power magnetic pole portion 23a1 of the fixed portion 23a is used as the S pole portion, and the second magnetic pole portion 23b2 having a magnetic pole different from that of the power magnetic pole portion 23a1 of the fixed portion 23a is N. The pole part.

[スライダー24]
スライダー24には、上述した台座部材21の側板部21bの当接ガイド部21b3(図9A、図9B参照)と当接することで直線状の移動方向Cに移動可能である。上述したように、本実施形態の移動部62は、スライダー24により構成されている。
[Slider 24]
The slider 24 can move in the linear moving direction C by contacting the contact guide portion 21b3 (see FIGS. 9A and 9B) of the side plate portion 21b of the pedestal member 21 described above. As described above, the moving portion 62 of the present embodiment is configured by the slider 24.

図9A、図9Bに示すように、本実施形態のスライダー24には、駆動装置23の回動部23bの円柱状の係合軸部23b5が嵌合する係合凹部24aが形成されている。本実施形態の係合凹部24aは、回動部23bの回動平面内において、スライダー24の直線状の移動方向Cと直交する方向に直線状に延在する長孔である。この係合凹部24aとしての長孔の移動方向Cにおける幅は、係合軸部23b5の最大径と略等しい。そのため、回動部23bが回動すると、係合軸部23b5は、係合凹部24aの移動方向Cの両側に位置する内壁24a1と、回動部23bの回動平面内で移動方向Cと直交する方向に当接する。このように当接しながら、係合軸部23b5は、係合凹部24aの内壁24a1をスライダー24の移動方向Cへと押圧する。これにより、スライダー24を移動方向Cに移動させることができる。また、本実施例では係合凹部24aはスライダー24の直線状の移動方向Cと直交する方向に直線状に延在する長孔で形成されている。ただし、係合凹部24aを湾曲した円弧状の長孔とすることで、スライダー24がC方向へ移動する際の移動量を増減することも可能である。 As shown in FIGS. 9A and 9B, the slider 24 of the present embodiment is formed with an engaging recess 24a into which the cylindrical engaging shaft portion 23b5 of the rotating portion 23b of the driving device 23 is fitted. The engaging recess 24a of the present embodiment is an elongated hole extending linearly in the rotation plane of the rotating portion 23b in a direction orthogonal to the linear moving direction C of the slider 24. The width of the elongated hole as the engaging recess 24a in the moving direction C is substantially equal to the maximum diameter of the engaging shaft portion 23b5. Therefore, when the rotating portion 23b rotates, the engaging shaft portion 23b5 is orthogonal to the inner walls 24a1 located on both sides of the engaging recess 24a in the moving direction C and the moving direction C in the rotating plane of the rotating portion 23b. Contact in the direction of While abutting in this way, the engaging shaft portion 23b5 presses the inner wall 24a1 of the engaging recess 24a in the moving direction C of the slider 24. As a result, the slider 24 can be moved in the moving direction C. Further, in this embodiment, the engaging recess 24a is formed by an elongated hole extending linearly in a direction orthogonal to the linear moving direction C of the slider 24. However, it is also possible to increase or decrease the amount of movement when the slider 24 moves in the C direction by forming the engaging recess 24a into a curved arc-shaped elongated hole.

スライダー24は、針保持部材25の自転する回動を規制しない。具体的には、針保持部材25は、針部材2の中心軸線Oを含む面に直交して延在している。この針保持部材25の延在する方向を軸方向とした場合に、スライダー24は、針保持部材25が軸方向周りに自転することを規制していない。つまり、針保持部材25は、軸方向周りに自転可能である。 The slider 24 does not regulate the rotation of the needle holding member 25. Specifically, the needle holding member 25 extends orthogonally to the surface of the needle member 2 including the central axis O. When the extending direction of the needle holding member 25 is the axial direction, the slider 24 does not restrict the needle holding member 25 from rotating around the axial direction. That is, the needle holding member 25 can rotate around the axial direction.

また、スライダー24は、針保持部材25の厚み方向Bの移動を規制しない。換言すれば、スライダー24は、針保持部材25の公転する回動を規制しない。具体的には、スライダー24は、針保持部材25を移動方向Cに押圧することで、針保持部材25を移動方向Cに移動させる。その一方で、スライダー24は、移動方向Cと直交する厚み方向Bにおいて、針保持部材25の移動を阻害しない。したがって、針保持部材25は、スライダー24に対して、厚み方向Bに移動可能である。これにより、針保持部材25は、針部材2の中心軸線Oを含む面と直交する所定の中心軸の周りを公転可能である。 Further, the slider 24 does not restrict the movement of the needle holding member 25 in the thickness direction B. In other words, the slider 24 does not regulate the revolving rotation of the needle holding member 25. Specifically, the slider 24 moves the needle holding member 25 in the moving direction C by pressing the needle holding member 25 in the moving direction C. On the other hand, the slider 24 does not hinder the movement of the needle holding member 25 in the thickness direction B orthogonal to the movement direction C. Therefore, the needle holding member 25 can move in the thickness direction B with respect to the slider 24. As a result, the needle holding member 25 can revolve around a predetermined central axis orthogonal to the surface including the central axis O of the needle member 2.

このように、スライダー24は、針保持部材25と係合して針保持部材25の移動方向Cへの移動を実現する。その一方で、スライダー24は、針保持部材25の軸方向周りの自転、及び、針保持部材25の、針部材2の中心軸線Oを含む面と直交する所定の中心軸の周りの公転、については規制しない。そのため、本実施形態の針部材2は、中心軸線Oを含む面内で、所定の2つの中心点の周りをそれぞれ回動する動きをする。針部材2の基端部を中心とした先端部の回動動作と、針部材2とは異なる位置の所定の中心軸の周りでの針部材2全体の回動動作である。前者の回動動作は、針保持部材25の上述した自転により引き起こされる。また、後者の回動動作は、針保持部材25の上述した公転により引き起こされる。 In this way, the slider 24 engages with the needle holding member 25 to realize the movement of the needle holding member 25 in the moving direction C. On the other hand, the slider 24 has a rotation around the axial direction of the needle holding member 25 and a revolution of the needle holding member 25 around a predetermined central axis orthogonal to the surface including the central axis O of the needle member 2. Does not regulate. Therefore, the needle member 2 of the present embodiment moves to rotate around two predetermined center points in the plane including the central axis O. The rotation operation of the tip portion around the base end portion of the needle member 2 and the rotation operation of the entire needle member 2 around a predetermined central axis at a position different from that of the needle member 2. The former rotational operation is caused by the above-mentioned rotation of the needle holding member 25. Further, the latter rotational operation is caused by the above-mentioned revolution of the needle holding member 25.

そのため、針部材2及び検出部材4を生体内に挿入する際、針部材2の外壁が台座部材21の通路21c1の湾曲面36(図10等参照)に当接する。これにより、針保持部材25の上述の自転及び/または公転が引き起こされる。その結果、針部材2の進行方向は、針部材2が回動することにより、変化する。 Therefore, when the needle member 2 and the detection member 4 are inserted into the living body, the outer wall of the needle member 2 comes into contact with the curved surface 36 (see FIG. 10 and the like) of the passage 21c1 of the pedestal member 21. This causes the above-mentioned rotation and / or revolution of the needle holding member 25. As a result, the traveling direction of the needle member 2 changes as the needle member 2 rotates.

つまり、本実施形態では、針部材2の外壁としての外周面が、台座部材21の通路21c1の内壁である湾曲面36に当接し、針保持部材25が上述の自転及び/または公転することにより、針部材2の中心軸線O(図5等参照)を含む面内での安定した回動が実現されている。以下、説明の便宜上、針部材2及び検出部材4が装着面3aから突出しない状態を、「第1状態」(図5、図7A、図10参照)と記載する。説明の便宜上、針部材2及び検出部材4が装着面3aから最も突出している状態を、「第2状態」(図6、図7B参照)と記載する。説明の便宜上、検出部材4のみが装着面3aから最も突出している状態を「第3状態」(図7C参照)と記載する。 That is, in the present embodiment, the outer peripheral surface of the needle member 2 as the outer wall abuts on the curved surface 36 which is the inner wall of the passage 21c1 of the pedestal member 21, and the needle holding member 25 rotates and / or revolves as described above. , Stable rotation in the plane including the central axis O (see FIG. 5 and the like) of the needle member 2 is realized. Hereinafter, for convenience of explanation, a state in which the needle member 2 and the detection member 4 do not protrude from the mounting surface 3a is referred to as a “first state” (see FIGS. 5, 7A, and 10). For convenience of explanation, the state in which the needle member 2 and the detection member 4 most protrude from the mounting surface 3a is referred to as a "second state" (see FIGS. 6 and 7B). For convenience of explanation, the state in which only the detection member 4 protrudes most from the mounting surface 3a is referred to as a "third state" (see FIG. 7C).

第1状態(図7A等参照)から第2状態(図7B等参照)に状態変化する際に、スライダー24は、検出部材4を支持する支持部材26を追従移動させることができる。図11に示すように、支持部材26には、第1状態から第2状態に形態変化する際に、スライダー24の一部に当接して係合する係合部34が設けられている。そのため、本実施形態の支持部材26は、第1状態から第2状態に状態変化する際に、図11に示す係合部34がスライダー24に係合することで、スライダー24と共に挿入移動方向C1に移動する。したがって、第1状態(図7A等参照)から第2状態(図7B参照)に状態変化する際に、支持部材26は、スライダー24の直線状の挿入移動方向C1への移動に追従して移動可能である。 When the state changes from the first state (see FIG. 7A or the like) to the second state (see FIG. 7B or the like), the slider 24 can follow-move the support member 26 that supports the detection member 4. As shown in FIG. 11, the support member 26 is provided with an engaging portion 34 that abuts and engages with a part of the slider 24 when the form changes from the first state to the second state. Therefore, when the support member 26 of the present embodiment changes state from the first state to the second state, the engaging portion 34 shown in FIG. 11 engages with the slider 24, so that the support member 26 is inserted together with the slider 24 in the insertion moving direction C1. Move to. Therefore, when the state changes from the first state (see FIG. 7A or the like) to the second state (see FIG. 7B), the support member 26 moves following the linear movement of the slider 24 in the insertion movement direction C1. It is possible.

これに対して、第2状態(図7B等参照)になると、スライダー24と支持部材26との係合は解除される。すなわち、本実施形態において、第2状態(図7B等参照)から第3状態(図7C参照)に状態変化する際、支持部材26は、スライダー24と共に抜去移動方向C2に移動しない。詳細は後述するが、第1状態(図7A等参照)から第2状態(図7B等参照)に状態変化する際に、針保持部材25が回動すると、支持部材26も針保持部材25及び針部材2に追従して、針部材2の中心軸線Oを含む断面(図5、図6等参照)において、回動する。この支持部材26の回動により、スライダー24の係合部34(図11参照)の厚み方向Bにおける位置が、スライダー24が直線状に移動する際に係合する位置から係合しない位置へと変化する。この詳細は後述する。 On the other hand, in the second state (see FIG. 7B and the like), the engagement between the slider 24 and the support member 26 is released. That is, in the present embodiment, when the state changes from the second state (see FIG. 7B or the like) to the third state (see FIG. 7C), the support member 26 does not move in the removal moving direction C2 together with the slider 24. Although the details will be described later, when the needle holding member 25 rotates when the state changes from the first state (see FIG. 7A or the like) to the second state (see FIG. 7B or the like), the support member 26 also becomes the needle holding member 25 and Following the needle member 2, it rotates in a cross section (see FIGS. 5, 6, etc.) including the central axis O of the needle member 2. Due to the rotation of the support member 26, the position of the engaging portion 34 (see FIG. 11) of the slider 24 in the thickness direction B changes from an engaging position when the slider 24 moves linearly to a non-engaging position. Change. The details will be described later.

また、本実施形態のスライダー24は、駆動装置23の磁力を用いて針部材2を移動させる構成である。より具体的に、本実施形態の移動部62としてのスライダー24は、引力及び斥力のうち、一方の磁力(本実施形態では斥力)により、針部材2を所定の一方向としての移動方向Cの一方側である挿入移動方向C1(図5、図6では左側)に移動させる。また、本実施形態の移動部62としてのスライダー24は、他方の磁力(本実施形態では引力)により、針部材2を移動方向Cの他方側である抜去移動方向C2(図5、図6では右側)に移動させる。このようにすることで、簡易な構成で針部材2の挿入動作及び抜去動作を実現できる。また、引力を利用すれば、本実施形態のように、抜去後の針部材2が衝撃等により再び飛び出すことを抑制することができる。この詳細については後述する(図13A、図13B、図13C参照)。 Further, the slider 24 of the present embodiment has a configuration in which the needle member 2 is moved by using the magnetic force of the driving device 23. More specifically, the slider 24 as the moving portion 62 of the present embodiment has a moving direction C in which the needle member 2 is set as a predetermined one direction by the magnetic force of one of the attractive force and the repulsive force (repulsive force in the present embodiment). It is moved in the insertion movement direction C1 (left side in FIGS. 5 and 6) on one side. Further, the slider 24 as the moving portion 62 of the present embodiment pulls out the needle member 2 on the other side of the moving direction C by the other magnetic force (attractive force in the present embodiment) and moves in the moving direction C2 (FIGS. 5 and 6). Move to the right side). By doing so, the insertion operation and the removal operation of the needle member 2 can be realized with a simple configuration. Further, if the attractive force is used, it is possible to prevent the needle member 2 after removal from popping out again due to an impact or the like, as in the present embodiment. The details will be described later (see FIGS. 13A, 13B and 13C).

スライダー24の材料としては、例えば、台座部材21の材料として例示した上述の材料と同一の材料を用いることができる。 As the material of the slider 24, for example, the same material as the above-mentioned material exemplified as the material of the pedestal member 21 can be used.

[針保持部材25]
図9〜図11に示すように、針保持部材25は、針部材2の基端部を保持している。本実施形態の針保持部材25は、針部材2の基端の位置で、針部材2の中心軸線Oを含む面と直交する方向に延在する棒状部材で構成されている。この針保持部材25は、上述したように、スライダー24に係合することで、スライダー24に追従して移動方向Cに移動する。また、針保持部材25は、上述したように、スライダー24に対して回動可能である。
[Needle holding member 25]
As shown in FIGS. 9 to 11, the needle holding member 25 holds the base end portion of the needle member 2. The needle holding member 25 of the present embodiment is formed of a rod-shaped member extending in a direction orthogonal to the surface including the central axis O of the needle member 2 at the position of the base end of the needle member 2. As described above, the needle holding member 25 moves in the moving direction C following the slider 24 by engaging with the slider 24. Further, the needle holding member 25 is rotatable with respect to the slider 24 as described above.

具体的に、針保持部材25は、スライダー24の直線状の移動方向Cの両側を、スライダー24の一部により挟まれている。したがって、スライダー24が直線状に移動方向Cに移動すると、針保持部材25は、スライダー24の一部と係合することで、移動方向Cに追従移動する。 Specifically, the needle holding member 25 is sandwiched by a part of the slider 24 on both sides of the slider 24 in the linear moving direction C. Therefore, when the slider 24 linearly moves in the moving direction C, the needle holding member 25 engages with a part of the slider 24 and moves following the moving direction C.

また、本実施形態の針保持部材25は、初期位置にあるとき、スライダー24に対して固定されていない。しかしながら、針保持部材25は、スライダー24が直線状に移動する際に、常に、スライダー24の一部に係合して追従移動できるように設計されている。具体的に、針保持部材25は、針保持部材25と係合するスライダー24の一部と、厚み方向Bで、スライダー24の移動方向Cに重なる位置、すなわち、スライダー24の移動時に常に干渉する(接触する)位置に、配置されている。これにより、針部材2が回動し、針保持部材25の厚み方向Bの位置が変動しても、針部材2及び針保持部材25を、スライダー24共に移動方向Cに追従移動させることができる。本実施形態では、針部材2の一部が常に通路21c1内に延在し、通路21c1の内壁により支持されている。このようにすることで、本実施形態の針保持部材25は、スライダー24の移動時に、常にスライダー24と干渉する位置に配置される。具体的に、本実施形態の針部材2は、針部材2の中心軸線Oを含む断面(図5等参照)において、ガイド部61としての湾曲面36と、台座部材21に設けられている受け部70と、により支持される。これにより、本実施形態の針部材2は、針部材2の中心軸線Oを含む面内での回動範囲が制限される。そのため、針保持部材25を、スライダー24の移動時に、常にスライダー24と干渉する位置に配置することができる。本実施形態の受け部70は、縁部を含む、湾曲面36と対向する通路21c1の内壁により構成されている。 Further, the needle holding member 25 of the present embodiment is not fixed to the slider 24 when it is in the initial position. However, the needle holding member 25 is designed so that when the slider 24 moves linearly, it is always engaged with a part of the slider 24 and can follow the movement. Specifically, the needle holding member 25 always interferes with a part of the slider 24 that engages with the needle holding member 25 at a position overlapping the moving direction C of the slider 24 in the thickness direction B, that is, when the slider 24 moves. It is placed at the (contact) position. As a result, even if the needle member 2 rotates and the position of the needle holding member 25 in the thickness direction B changes, both the needle member 2 and the needle holding member 25 can be moved following the moving direction C together with the slider 24. .. In the present embodiment, a part of the needle member 2 always extends in the passage 21c1 and is supported by the inner wall of the passage 21c1. By doing so, the needle holding member 25 of the present embodiment is always arranged at a position where it interferes with the slider 24 when the slider 24 is moved. Specifically, the needle member 2 of the present embodiment has a curved surface 36 as a guide portion 61 and a receiver provided on the pedestal member 21 in a cross section (see FIG. 5 and the like) including the central axis O of the needle member 2. Supported by section 70. As a result, the needle member 2 of the present embodiment is limited in the range of rotation in the plane including the central axis O of the needle member 2. Therefore, the needle holding member 25 can always be arranged at a position where it interferes with the slider 24 when the slider 24 is moved. The receiving portion 70 of the present embodiment is composed of an inner wall of the passage 21c1 facing the curved surface 36, including the edge portion.

針保持部材25の材料としては、例えば、台座部材21の材料として例示した上述の材料と同一の材料を用いることができる。 As the material of the needle holding member 25, for example, the same material as the above-mentioned material exemplified as the material of the pedestal member 21 can be used.

[支持部材26]
図11に示すように、支持部材26は、検出部材4を支持している。より具体的に、支持部材26は、検出部材4の先端側部4aが針部材2内で針部材2の延在方向Aに延在するように支持している。検出部材4のうち支持部材26に支持されている位置よりも基端側は、導線を介して回路基板28の第1電気接点部28aに接続されている基端側部4bにより構成されている。
[Support member 26]
As shown in FIG. 11, the support member 26 supports the detection member 4. More specifically, the support member 26 supports the tip side portion 4a of the detection member 4 so as to extend in the needle member 2 in the extending direction A of the needle member 2. The base end side of the detection member 4 from the position supported by the support member 26 is composed of a base end side portion 4b connected to the first electric contact portion 28a of the circuit board 28 via a conducting wire. ..

本実施形態の支持部材26は、針部材2が挿通される挿通孔26a1が形成されている板状の本体部26aと、この本体部26aから略平行に突出し、互いに対向する第1壁部26b及び第2壁部26cと、を備える。 The support member 26 of the present embodiment has a plate-shaped main body portion 26a in which an insertion hole 26a1 through which the needle member 2 is inserted is formed, and a first wall portion 26b that projects substantially parallel to the main body portion 26a and faces each other. And a second wall portion 26c.

図11に示すように、針部材2及び検出部材4は、支持部材26の本体部26aに形成されている挿通孔26a1に挿通されて延在している。換言すれば、支持部材26は、挿通孔26a1を貫通する針部材2の外壁上に支持されている。挿通孔26a1は、厚み方向Bに長尺な長孔であり、針部材2及び検出部材4が回動する際に、厚み方向Bに移動可能に形成されている。 As shown in FIG. 11, the needle member 2 and the detection member 4 are inserted into and extend through the insertion hole 26a1 formed in the main body portion 26a of the support member 26. In other words, the support member 26 is supported on the outer wall of the needle member 2 penetrating the insertion hole 26a1. The insertion hole 26a1 is a long hole elongated in the thickness direction B, and is formed so as to be movable in the thickness direction B when the needle member 2 and the detection member 4 rotate.

また、図11に示すように、第1壁部26bのうち、第2壁部26cと対向する内側面とは反対側の外側面には、スライダー24に係合する係合部34としての係合突起が形成されている。同様に、第2壁部26cのうち、第1壁部26bと対向する内側面とは反対側の外側面には、スライダー24に係合する係合部34としての係合突起が形成されている。スライダー24が移動する際は、スライダー24の一部が上述の係合部34に係合することで、支持部材26を移動方向Cに追従移動させることができる。 Further, as shown in FIG. 11, of the first wall portion 26b, the outer surface opposite to the inner surface facing the second wall portion 26c is engaged as an engaging portion 34 that engages with the slider 24. Synthetic protrusions are formed. Similarly, of the second wall portion 26c, an engaging projection as an engaging portion 34 that engages with the slider 24 is formed on the outer surface of the second wall portion 26c on the side opposite to the inner surface facing the first wall portion 26b. There is. When the slider 24 moves, a part of the slider 24 engages with the above-mentioned engaging portion 34, so that the support member 26 can be moved following the moving direction C.

更に、図11に示すように、第1壁部26bのうち、第2壁部26cと対向する内側面には、係合凸部35が形成されている。第1壁部26bの係合凸部35は、上述した第2状態(図7B等参照)になった場合に、台座部材21の突出部21cの外面に形成されている係合凹部21c2(図9A、図9B参照)に嵌合する。同様に、第2壁部26cのうち、第1壁部26bと対向する内側面においても、係合凸部35が形成されている。第2壁部26cの係合凸部35についても、上述した第2状態(図7B等参照)になった場合に、台座部材21の突出部21cの外面に形成されている係合凹部21c2に嵌合する。詳細は後述するが、上述した第2状態(図7B等参照)になると、支持部材26は、第1壁部26b及び第2壁部26cとで台座部材21の突出部21c(図9A、図9B等参照)を挟み込む。その際に、第1壁部26bの係合凸部35及び第2壁部26cの係合凸部35が、突出部21cの係合凹部21c2(図9A、図9B参照)に嵌り込み、突出部21cから支持部材26が離間し難い状態にすることができる。このようにすることで、生体内に挿入後の針部材2を生体外に抜去する際に、支持部材26が突出部21cに対して係止された状態を維持できる(図7C参照)。その結果、支持部材26に支持されている検出部材4が、針部材2と共に生体外に抜去されることを、抑制することができる。この詳細は後述する(図13A、図13B、図13C参照)。 Further, as shown in FIG. 11, of the first wall portion 26b, an engaging convex portion 35 is formed on the inner side surface facing the second wall portion 26c. The engaging convex portion 35 of the first wall portion 26b is an engaging concave portion 21c2 (FIG. 7B) formed on the outer surface of the protruding portion 21c of the pedestal member 21 when the above-mentioned second state (see FIG. 7B or the like) is reached. 9A, see FIG. 9B). Similarly, of the second wall portion 26c, the engaging convex portion 35 is also formed on the inner side surface facing the first wall portion 26b. The engaging convex portion 35 of the second wall portion 26c is also formed in the engaging concave portion 21c2 formed on the outer surface of the protruding portion 21c of the pedestal member 21 when the above-mentioned second state (see FIG. 7B or the like) is reached. Fit. Details will be described later, but in the second state described above (see FIG. 7B and the like), the support member 26 includes the first wall portion 26b and the second wall portion 26c, and the protruding portion 21c of the pedestal member 21 (FIG. 9A, FIG. (See 9B, etc.) is inserted. At that time, the engaging convex portion 35 of the first wall portion 26b and the engaging convex portion 35 of the second wall portion 26c are fitted into the engaging concave portion 21c2 (see FIGS. 9A and 9B) of the protruding portion 21c and protrude. The support member 26 can be made difficult to separate from the portion 21c. By doing so, when the needle member 2 after being inserted into the living body is removed from the living body, the support member 26 can be maintained in a state of being locked to the protruding portion 21c (see FIG. 7C). As a result, it is possible to prevent the detection member 4 supported by the support member 26 from being removed from the living body together with the needle member 2. The details will be described later (see FIGS. 13A, 13B and 13C).

支持部材26の材料としては、例えば、台座部材21の材料として例示した上述の材料と同一の材料を用いることができる。 As the material of the support member 26, for example, the same material as the above-mentioned material exemplified as the material of the pedestal member 21 can be used.

[駆動制御部材27]
駆動制御部材27は、駆動装置23による駆動動作を制御する。具体的に、本実施形態の駆動制御部材27は、駆動装置23の回動部23bが、固定部23aの動力磁極部23a1との間の斥力の磁力により回動することを、回動部23bに当接することで規制する回動規制部32を備える。回動規制部32は、回動部23bの段差部23b4(図12参照)に形成されている係合壁部31(図12参照)に当接することで、回動部23bの回動を規制することができる。
[Drive control member 27]
The drive control member 27 controls the drive operation by the drive device 23. Specifically, in the drive control member 27 of the present embodiment, the rotating portion 23b of the driving device 23 rotates by the magnetic force of the repulsive force between the rotating portion 23b and the power magnetic pole portion 23a1 of the fixed portion 23a. A rotation restricting unit 32 that regulates by contacting the magnet 32 is provided. The rotation restricting portion 32 restricts the rotation of the rotating portion 23b by contacting the engaging wall portion 31 (see FIG. 12) formed on the stepped portion 23b4 (see FIG. 12) of the rotating portion 23b. can do.

本実施形態の駆動制御部材27の回動規制部32は、回動部23bの周方向のうち一方向(図9A、図9Bで反時計回りの方向)の回動を規制しており、回動部23bの周方向の逆方向(図9A、図9Bで時計回りの方向)の回動を規制していない。回動部23bの逆方向への回動の規制については、上述の回動制御凸部21a3(図9B参照)が、回動部23bの下面に形成されている長孔23b3(図12参照)に入り込み、長孔23b3を区画する壁面に突き当たることで実現されている。 The rotation restricting portion 32 of the drive control member 27 of the present embodiment regulates the rotation of the rotating portion 23b in one of the circumferential directions (counterclockwise in FIGS. 9A and 9B). The rotation of the moving portion 23b in the opposite direction to the circumferential direction (clockwise in FIGS. 9A and 9B) is not restricted. Regarding the regulation of the rotation of the rotating portion 23b in the opposite direction, the above-mentioned rotation control convex portion 21a3 (see FIG. 9B) is formed in the lower surface of the rotating portion 23b with a long hole 23b3 (see FIG. 12). It is realized by entering and hitting the wall surface that partitions the elongated hole 23b3.

より具体的に、本実施形態の駆動制御部材27は、板状の本体部27aと、第1突出板部27bと、第2突出板部27cと、を備える。板状の本体部27aは、台座部材21の底板部21aの取付面上に配置されている。第1突出板部27bは、この本体部27aの一端に連続して形成され、本体部27aの厚み方向(本実施形態では厚み方向Bと同じ方向)に突出する。第2突出板部27cは、本体部27aの別の一端に連続して形成され、本体部27aの厚み方向に突出する。本実施形態の上述の回動規制部32は、第1突出板部27bにより構成されている。また、第2突出板部27cは、後述する操作部材29に係合している。したがって、操作部材29が押圧されると、第2突出板部27cが押圧される。これにより、本体部27a及び第1突出板部27bが移動し、回動規制部32としての第1突出板部27bによる回動部23bの回動規制が解除される。その結果、駆動装置23を作動することができる。すなわち、回動部23bを、図9A、図9Bの斜視で反時計回りに回動させることができる。 More specifically, the drive control member 27 of the present embodiment includes a plate-shaped main body portion 27a, a first protruding plate portion 27b, and a second protruding plate portion 27c. The plate-shaped main body 27a is arranged on the mounting surface of the bottom plate 21a of the pedestal member 21. The first protruding plate portion 27b is continuously formed at one end of the main body portion 27a, and projects in the thickness direction of the main body portion 27a (in the present embodiment, the same direction as the thickness direction B). The second protruding plate portion 27c is continuously formed at another end of the main body portion 27a and projects in the thickness direction of the main body portion 27a. The above-mentioned rotation restricting portion 32 of the present embodiment is composed of a first protruding plate portion 27b. Further, the second protruding plate portion 27c is engaged with an operation member 29 described later. Therefore, when the operating member 29 is pressed, the second protruding plate portion 27c is pressed. As a result, the main body portion 27a and the first protruding plate portion 27b move, and the rotation restriction of the rotating portion 23b by the first protruding plate portion 27b as the rotation restricting portion 32 is released. As a result, the drive device 23 can be operated. That is, the rotating portion 23b can be rotated counterclockwise from the perspective of FIGS. 9A and 9B.

図9A、図9Bに示すように、本実施形態の第2突出板部27cは、操作部材29を付勢する付勢部27c1としての板ばね部を備える。この付勢部27c1により、操作部材29の初期位置を維持すると共に、第1突出板部27bが回動部23bと当接して回動を規制する位置を維持することができる。 As shown in FIGS. 9A and 9B, the second protruding plate portion 27c of the present embodiment includes a leaf spring portion as an urging portion 27c1 for urging the operating member 29. The urging portion 27c1 can maintain the initial position of the operating member 29 and maintain the position where the first protruding plate portion 27b comes into contact with the rotating portion 23b to regulate the rotation.

駆動制御部材27の材料としては、例えば、ばね性をもった鉄や、ステンレスなどの金属板を用いることができる。 As the material of the drive control member 27, for example, a metal plate such as iron having a spring property or stainless steel can be used.

[回路基板28]
図9Aに示すように、回路基板28は、台座部材21の底板部21aの取付面上に配置されている。回路基板28には電気回路が形成されており、この電気回路は、第1電気接点部28aを介して、検出部材4(図11等参照)と電気的に接続されている。また、回路基板28は第2電気接点部28bを備えている。この第2電気接点部28bは、後述するカバー部材12の回路基板43の電気接点部43aに接続される端子により構成されている。これにより、検出部材4により検出される被計測物質の電気信号を、ベース部材11の回路基板28の電気回路、及び、カバー部材12の回路基板43の電気回路、を通じて、後述するカバー部材12の通信装置42に送信することができる。
[Circuit board 28]
As shown in FIG. 9A, the circuit board 28 is arranged on the mounting surface of the bottom plate portion 21a of the pedestal member 21. An electric circuit is formed on the circuit board 28, and the electric circuit is electrically connected to the detection member 4 (see FIG. 11 and the like) via the first electric contact portion 28a. Further, the circuit board 28 includes a second electrical contact portion 28b. The second electrical contact portion 28b is composed of terminals connected to the electrical contact portion 43a of the circuit board 43 of the cover member 12, which will be described later. As a result, the electric signal of the material to be measured detected by the detection member 4 is transmitted to the cover member 12 described later through the electric circuit of the circuit board 28 of the base member 11 and the electric circuit of the circuit board 43 of the cover member 12. It can be transmitted to the communication device 42.

[操作部材29]
操作部材29は、留置装置1としての生体情報検出装置の外部に露出する操作部を構成する。操作部材29を内部空間X(図10参照)に向かって押し込むことにより、上述の駆動制御部材27を移動させ、駆動装置23を作動させることができる。
[Operating member 29]
The operation member 29 constitutes an operation unit exposed to the outside of the biological information detection device as the indwelling device 1. By pushing the operating member 29 toward the internal space X (see FIG. 10), the drive control member 27 described above can be moved and the drive device 23 can be operated.

図10に示すように、本実施形態の操作部材29は、圧縮部29aと、外端部29bと、括れ部29cと、を備える。圧縮部29aは、未使用状態の留置装置1において、台座部材21の側板部21bの開口部21b1を区画する内壁に、厚み方向Bで圧縮されている部分である。また、外端部29bは、圧縮部29aよりも側板部21bの外側に位置し、開口部21b1よりも厚み方向Bの厚さが厚く、未使用状態の留置装置1において、操作する被検者等により押圧される部分である。更に、括れ部29cは、圧縮部29aと外端部29bとの間に位置し、厚み方向Bにおける厚さが、圧縮部29a及び外端部29bよりも薄い部分である。未使用状態の留置装置1において、操作部材29が押し込まれると、括れ部29cにより区画される凹部に、側板部21bの開口部21b1を区画する内壁が入り込む(図6参照)。これにより、押し込まれた操作部材29が、再び初期位置に復帰することを抑制できる。そのため、駆動制御部材27の回動規制部32が初期位置に復帰することが抑制される。その結果、回動部23bの回動動作が、初期位置に復帰しようとする回動規制部32との当接等により、阻害されることを抑制することができる。 As shown in FIG. 10, the operation member 29 of the present embodiment includes a compression portion 29a, an outer end portion 29b, and a constriction portion 29c. The compression portion 29a is a portion of the indwelling device 1 in the unused state that is compressed in the thickness direction B on the inner wall that partitions the opening 21b1 of the side plate portion 21b of the pedestal member 21. Further, the outer end portion 29b is located outside the side plate portion 21b with respect to the compression portion 29a, is thicker in the thickness direction B than the opening portion 21b1, and is operated by the indwelling device 1 in an unused state. It is a part that is pressed by such as. Further, the constricted portion 29c is located between the compression portion 29a and the outer end portion 29b, and the thickness in the thickness direction B is thinner than that of the compression portion 29a and the outer end portion 29b. When the operating member 29 is pushed in the indwelling device 1 in the unused state, the inner wall for partitioning the opening 21b1 of the side plate portion 21b enters the recess defined by the constricted portion 29c (see FIG. 6). As a result, it is possible to prevent the pushed operating member 29 from returning to the initial position again. Therefore, it is suppressed that the rotation restricting portion 32 of the drive control member 27 returns to the initial position. As a result, it is possible to prevent the rotational operation of the rotating portion 23b from being hindered by contact with the rotation restricting portion 32 that is about to return to the initial position.

操作部材29の材料としては、例えば、ゴムや、エラストマのような柔軟性をもった素材の材料を用いることができる。 As the material of the operating member 29, for example, a material having flexibility such as rubber or an elastomer can be used.

<カバー部材12>
図8、図10に示すように、カバー部材12は、蓄電部材41と、通信装置42と、回路基板43と、ハウジング44と、を備える。
<Cover member 12>
As shown in FIGS. 8 and 10, the cover member 12 includes a power storage member 41, a communication device 42, a circuit board 43, and a housing 44.

[蓄電部材41]
本実施形態の蓄電部材41はボタン電池であるが、通信装置42を動作させる電力を供給可能な蓄電部材41であればよく、ボタン電池に限られない。
[Power storage member 41]
The power storage member 41 of the present embodiment is a button battery, but it is not limited to the button battery as long as it is a power storage member 41 capable of supplying electric power for operating the communication device 42.

[通信装置42]
図10に示すように、通信装置42は、制御部42aと、送信部42bと、を備える。制御部42aは、プロセッサ、メモリ等により構成されており、検出部材4が検出した被計測物質の情報を取得し、解析する。送信部42bは、制御部42aの解析結果を、制御部42aからの命令により、例えばスマートフォンやコンピュータなどの外部装置に対して送信する。これにより、被検者本人や、医師等の医療従事者は、外部装置を通じて、留置装置1としての生体情報検出装置による計測結果を確認することができる。
[Communication device 42]
As shown in FIG. 10, the communication device 42 includes a control unit 42a and a transmission unit 42b. The control unit 42a is composed of a processor, a memory, and the like, and acquires and analyzes information on the substance to be measured detected by the detection member 4. The transmission unit 42b transmits the analysis result of the control unit 42a to an external device such as a smartphone or a computer by a command from the control unit 42a. As a result, the subject himself or a medical worker such as a doctor can confirm the measurement result by the biological information detection device as the indwelling device 1 through the external device.

[回路基板43]
図10に示すように、回路基板43には、通信装置42と接続されている電気回路が形成されている。また、図8に示すように、回路基板43上の電気回路には、カバー部材12が上述したベース部材11に対して装着される場合に、ベース部材11の回路基板28上の電気回路の第2電気接点部28bと接触する電気接点部43aが設けられている。したがって、ベース部材11及びカバー部材12が組み合わされた状態で、検出部材4は、回路基板28の電気回路、及び、回路基板43の電気回路、を通じて、通信装置42と導通する。電気接点部43aの数は、検出部材4を構成する電極の数(本実施形態では3本)に応じて増減する。
[Circuit board 43]
As shown in FIG. 10, an electric circuit connected to the communication device 42 is formed on the circuit board 43. Further, as shown in FIG. 8, in the electric circuit on the circuit board 43, when the cover member 12 is mounted on the base member 11 described above, the electric circuit on the circuit board 28 of the base member 11 is the first. 2 An electrical contact portion 43a that comes into contact with the electrical contact portion 28b is provided. Therefore, in a state where the base member 11 and the cover member 12 are combined, the detection member 4 conducts with the communication device 42 through the electric circuit of the circuit board 28 and the electric circuit of the circuit board 43. The number of electrical contact portions 43a increases or decreases depending on the number of electrodes constituting the detection member 4 (three in this embodiment).

[ハウジング44]
ハウジング44は、カバー部材12の外装部材であり、かつ、カバー部材12がベース部材11に取り付けられて形成される留置装置1としての生体情報検出装置における外装部材でもある。
[Housing 44]
The housing 44 is an exterior member of the cover member 12, and is also an exterior member of the biological information detection device as the indwelling device 1 formed by attaching the cover member 12 to the base member 11.

本実施形態のハウジング44は、上面視(図4参照)でオーバル形状の外形を有している。また、図10に示すように、本実施形態のハウジング44は、上面板部44aと、この上面板部44aの外縁から上面板部44aの厚み方向に突出する環状の周囲側板部44bと、を備える。周囲側板部44bの周方向の一部には、切欠部44b1が形成されている。カバー部材12をベース部材11に装着した場合に、ベース部材11の操作部材29のうち側板部21bの外側に突出する部分が、切欠部44b1の位置に収容される。これにより、ベース部材11にカバー部材12を装着した留置装置1の状態でも、操作部材29を外部から操作することができる。 The housing 44 of the present embodiment has an oval-shaped outer shape when viewed from above (see FIG. 4). Further, as shown in FIG. 10, the housing 44 of the present embodiment has an upper surface plate portion 44a and an annular peripheral side plate portion 44b protruding from the outer edge of the upper surface plate portion 44a in the thickness direction of the upper surface plate portion 44a. Be prepared. A notch 44b1 is formed in a part of the peripheral side plate portion 44b in the circumferential direction. When the cover member 12 is attached to the base member 11, the portion of the operating member 29 of the base member 11 that protrudes to the outside of the side plate portion 21b is accommodated at the position of the notch portion 44b1. As a result, the operating member 29 can be operated from the outside even in the state of the indwelling device 1 in which the cover member 12 is attached to the base member 11.

また、図8、図10に示すように、周囲側板部44bの内面には、内面凹部44b2が形成されている。カバー部材12は、内面凹部44b2に外面凸部21b2を嵌合することで、ベース部材11に装着される。 Further, as shown in FIGS. 8 and 10, an inner surface recess 44b2 is formed on the inner surface of the peripheral side plate portion 44b. The cover member 12 is attached to the base member 11 by fitting the outer surface convex portion 21b2 into the inner surface concave portion 44b2.

上面板部44aの下面側で、周囲側板部44bに囲まれる空間に、蓄電部材41と、通信装置42と、回路基板43と、が配置されている。 A power storage member 41, a communication device 42, and a circuit board 43 are arranged in a space surrounded by a peripheral side plate portion 44b on the lower surface side of the upper surface plate portion 44a.

ハウジング44の材料としては、例えば、台座部材21の材料として例示した上述の材料と同一の材料を用いることができる。 As the material of the housing 44, for example, the same material as the above-mentioned material exemplified as the material of the pedestal member 21 can be used.

[ベース部材11における挿入機構]
次に、本実施形態の挿入機構について説明する。本実施形態の挿入機構は、ベース部材11に含まれている。より具体的に、本実施形態の挿入機構は、台座部材21、駆動装置23、スライダー24、及び、針保持部材25、により構成されている。台座部材21の底板部21aに取り付けられている駆動装置23が作動することで移動部62としてのスライダー24が移動する。これにより、台座部材21の突出部21c内のガイド部61としての湾曲面36と当接する針部材2が、針保持部材25が回動することにより回動する。そのため、針部材2を装着面3aから突出させ、針部材2を生体内に挿入することができる。
[Insert mechanism in base member 11]
Next, the insertion mechanism of the present embodiment will be described. The insertion mechanism of the present embodiment is included in the base member 11. More specifically, the insertion mechanism of the present embodiment is composed of a pedestal member 21, a drive device 23, a slider 24, and a needle holding member 25. The slider 24 as the moving portion 62 moves by operating the driving device 23 attached to the bottom plate portion 21a of the pedestal member 21. As a result, the needle member 2 that comes into contact with the curved surface 36 as the guide portion 61 in the protruding portion 21c of the pedestal member 21 rotates as the needle holding member 25 rotates. Therefore, the needle member 2 can be projected from the mounting surface 3a and the needle member 2 can be inserted into the living body.

[ベース部材11における挿入機構のガイド部61]
上述したように、本実施形態の台座部材21は、通路21c1が形成されている突出部21cを備える(図10等参照)。そして、通路21c1を区画する内壁は、針部材2及び検出部材4の生体内への挿入動作時に、針部材2に当接し、中心軸線Oを含む面内で針部材2を回動させる。つまり、図10等に示すように、本実施形態のガイド部61は、通路21c1を区画する内壁の湾曲面36により構成されている。
[Guide portion 61 of the insertion mechanism in the base member 11]
As described above, the pedestal member 21 of the present embodiment includes a protruding portion 21c in which the passage 21c1 is formed (see FIG. 10 and the like). Then, the inner wall that partitions the passage 21c1 comes into contact with the needle member 2 during the insertion operation of the needle member 2 and the detection member 4 into the living body, and rotates the needle member 2 in the plane including the central axis O. That is, as shown in FIG. 10 and the like, the guide portion 61 of the present embodiment is composed of the curved surface 36 of the inner wall that partitions the passage 21c1.

[ベース部材11における挿入機構の移動部62]
また、上述したように、本実施形態のスライダー24は、直線状の移動方向Cに移動可能である。本実施形態のスライダー24は、針部材2及び検出部材4の生体内への挿入動作時において、針部材2を、所定の一方向として移動方向Cの一方側である挿入移動方向C1に移動させることが可能である。つまり、図10等に示すように、本実施形態の移動部62は、スライダー24により構成されている。
[Moving portion 62 of the insertion mechanism in the base member 11]
Further, as described above, the slider 24 of the present embodiment can move in the linear moving direction C. The slider 24 of the present embodiment moves the needle member 2 in the insertion moving direction C1 which is one side of the moving direction C as a predetermined direction when the needle member 2 and the detection member 4 are inserted into the living body. It is possible. That is, as shown in FIG. 10 and the like, the moving portion 62 of the present embodiment is configured by the slider 24.

ガイド部61としての湾曲面36は、針部材2及び検出部材4の挿入動作時において、移動部62としてのスライダー24により移動している針部材2に当接する。これにより、針部材2は、中心軸線Oを含む面内で回動する。このように、針部材2の先端の進行方向は、ガイド部61としての湾曲面36により、挿入移動方向C1から変化する。このとき、針部材2のスリット開口2aは、湾曲面36側に開口しない。湾曲面36と検出部材4が当接することがないため、検出部材4が保護される。 The curved surface 36 as the guide portion 61 comes into contact with the needle member 2 moving by the slider 24 as the moving portion 62 during the insertion operation of the needle member 2 and the detection member 4. As a result, the needle member 2 rotates in the plane including the central axis O. In this way, the traveling direction of the tip of the needle member 2 changes from the insertion moving direction C1 due to the curved surface 36 as the guide portion 61. At this time, the slit opening 2a of the needle member 2 does not open on the curved surface 36 side. Since the curved surface 36 does not come into contact with the detection member 4, the detection member 4 is protected.

より具体的に、ガイド部61としての湾曲面36は、針部材2及び検出部材4の挿入動作時において、移動方向C及び挿入移動方向C1、と略直交する厚み方向Bに、針部材2の先端の進行方向を変化させる。これにより針部材2及び検出部材4の挿入動作が安定化する。 More specifically, the curved surface 36 as the guide portion 61 is located in the thickness direction B substantially orthogonal to the moving direction C and the insertion moving direction C1 during the insertion operation of the needle member 2 and the detection member 4. Change the direction of travel of the tip. As a result, the insertion operation of the needle member 2 and the detection member 4 is stabilized.

ここで、本実施形態の挿入機構の移動部62は、針部材2を所定の一方向としての挿入移動方向C1とは逆方向に戻り移動させることが可能である。つまり、本実施形態の挿入機構の移動部62としてのスライダー24は、針部材2及び検出部材4の挿入動作時における挿入移動方向C1への移動のみならず、挿入移動方向C1の逆方向である抜去移動方向C2に移動することが可能である。つまり、スライダー24は、挿入移動方向C1に移動することで、針部材2及び検出部材4を装着面3aから突出させる挿入動作(図7Aの状態から図7Bの状態への状態変化)を実現する。更に、スライダー24は、抜去移動方向C2に戻り移動することで、針部材2を装着面3aから突出させないように移動する。すなわち、スライダー24の移動により、針部材2を留置装置1の装置本体3(図1等参照)の内部に収容する抜去動作(図7Bの状態から図7Cの状態への状態変化)が実現される。 Here, the moving portion 62 of the insertion mechanism of the present embodiment can return and move the needle member 2 in the direction opposite to the insertion moving direction C1 as a predetermined one direction. That is, the slider 24 as the moving portion 62 of the insertion mechanism of the present embodiment is not only moved in the insertion moving direction C1 during the insertion operation of the needle member 2 and the detection member 4, but also in the opposite direction of the insertion moving direction C1. It is possible to move in the removal moving direction C2. That is, the slider 24 realizes an insertion operation (state change from the state of FIG. 7A to the state of FIG. 7B) in which the needle member 2 and the detection member 4 are projected from the mounting surface 3a by moving in the insertion movement direction C1. .. Further, the slider 24 moves by returning to the removal moving direction C2 so that the needle member 2 does not protrude from the mounting surface 3a. That is, by moving the slider 24, the removal operation (state change from the state of FIG. 7B to the state of FIG. 7C) in which the needle member 2 is housed inside the device main body 3 (see FIG. 1 and the like) of the indwelling device 1 is realized. Ru.

図13A、図13B、図13Cは、台座カバー部材22(図9A等参照)を省略して描いたベース部材11を示す斜視図である。図13Aは、未使用状態の留置装置1におけるベース部材11を示す。図13Bは、図13Aの状態から挿入機構を作動させ、針部材2及び検出部材4を、装着面3a(図2等参照)から最も突出させた状態のベース部材11を示す。図13Cは、図13Bの状態からスライダー24を抜去移動方向C2に戻り移動させ、検出部材4を装着面3aから突出させた状態のまま、針部材2のみを引き戻して内部に収容した状態のベース部材11を示す。 13A, 13B, and 13C are perspective views showing a base member 11 drawn by omitting the pedestal cover member 22 (see FIG. 9A and the like). FIG. 13A shows the base member 11 in the indwelling device 1 in the unused state. FIG. 13B shows the base member 11 in a state in which the insertion mechanism is operated from the state of FIG. 13A and the needle member 2 and the detection member 4 are most projected from the mounting surface 3a (see FIG. 2 and the like). FIG. 13C shows a base in which the slider 24 is pulled out from the state of FIG. 13B and moved back to the moving direction C2, and while the detection member 4 is projected from the mounting surface 3a, only the needle member 2 is pulled back and housed inside. The member 11 is shown.

図5、図6、図13A、図13Bに示すように、針部材2が挿入機構の移動部62としてのスライダー24により挿入移動方向C1に移動する場合に、検出部材4及び支持部材26は、検出部材4の先端側部4a(図11参照)が針部材2の内部に延在する状態で、針部材2と共に挿入移動方向C1に移動する。 As shown in FIGS. 5, 6, 13A, and 13B, when the needle member 2 is moved in the insertion moving direction C1 by the slider 24 as the moving portion 62 of the insertion mechanism, the detection member 4 and the support member 26 are moved. The tip side portion 4a (see FIG. 11) of the detection member 4 moves in the insertion moving direction C1 together with the needle member 2 in a state of extending inside the needle member 2.

また、図6、図13Bに示すように、針部材2が挿入機構の移動部62としてのスライダー24により挿入移動方向C1に移動する場合に、検出部材4及び支持部材26は、針部材2と共に挿入機構のガイド部61としての通路21c1の湾曲面36により回動する。これにより、針部材2が抜去移動方向C2に戻り移動する際に、検出部材4が針部材2に追従して移動しない姿勢へと変化する。 Further, as shown in FIGS. 6 and 13B, when the needle member 2 is moved in the insertion moving direction C1 by the slider 24 as the moving portion 62 of the insertion mechanism, the detection member 4 and the support member 26 are together with the needle member 2. It is rotated by the curved surface 36 of the passage 21c1 as the guide portion 61 of the insertion mechanism. As a result, when the needle member 2 returns to the removal moving direction C2 and moves, the detection member 4 changes to a posture in which the detection member 4 follows the needle member 2 and does not move.

より具体的に、支持部材26は、スライダー24に係合する係合部34としての係合突起を備えている。係合部34としての係合突起は、図13Aの状態から図13Bの状態に変化するまで、スライダー24と移動方向Cで重なる位置にある。そのため、支持部材26は、図13Aの状態から図13Bの状態に変化するまで、スライダー24により係合部34としての係合突起が押圧されることで、スライダー24と共に挿入移動方向C1に追従移動する。 More specifically, the support member 26 includes an engaging projection as an engaging portion 34 that engages the slider 24. The engaging protrusion as the engaging portion 34 is in a position where it overlaps with the slider 24 in the moving direction C until the state of FIG. 13A changes to the state of FIG. 13B. Therefore, the support member 26 moves following the insertion movement direction C1 together with the slider 24 by pressing the engaging projection as the engaging portion 34 by the slider 24 until the state changes from the state of FIG. 13A to the state of FIG. 13B. To do.

しかしながら、係合部34としての係合突起は、図13Bの状態になると、スライダー24と係合する位置からスライダー24と係合しない位置へと、厚み方向B(図5、図6参照)の装着面3a側に移動する。この移動は、針保持部材25のスライダー24に対する回動により発生する。針保持部材25が回動すると針部材2も回動する。そのため、針部材2の外周面上に支持されている支持部材26もまた回動する。この支持部材26の回動により、支持部材26の係合部34としての係合突起と、スライダー24と、の干渉関係が変動する。すなわち、支持部材26及びこの支持部材26に支持されている検出部材4は、針部材2が抜去移動方向C2に戻り移動する際に追従移動しない姿勢へと変化する。 However, when the engaging protrusion as the engaging portion 34 is in the state of FIG. 13B, the engaging protrusion is in the thickness direction B (see FIGS. 5 and 6) from the position where it engages with the slider 24 to the position where it does not engage with the slider 24. Move to the mounting surface 3a side. This movement is generated by the rotation of the needle holding member 25 with respect to the slider 24. When the needle holding member 25 rotates, the needle member 2 also rotates. Therefore, the support member 26 supported on the outer peripheral surface of the needle member 2 also rotates. Due to the rotation of the support member 26, the interference relationship between the engaging protrusion as the engaging portion 34 of the support member 26 and the slider 24 changes. That is, the support member 26 and the detection member 4 supported by the support member 26 change to a posture in which the needle member 2 does not follow and move when the needle member 2 returns to the removal movement direction C2 and moves.

更に、支持部材26は、図13Bの状態になると、台座部材21の突出部21cを挟み込み、台座部材21に係止される。そのため、支持部材26及びこの支持部材26に支持されている検出部材4の抜去移動方向C2への戻り移動は、より確実に抑制される。 Further, when the support member 26 is in the state shown in FIG. 13B, the support member 26 sandwiches the protruding portion 21c of the pedestal member 21 and is locked to the pedestal member 21. Therefore, the return movement of the support member 26 and the detection member 4 supported by the support member 26 in the removal movement direction C2 is more reliably suppressed.

以上のように、移動部62としてのスライダー24が抜去移動方向C2に戻り移動し、図13Bの状態から図13Cの状態に変化しても、支持部材26及びこの支持部材26に支持されている検出部材4は、スライダー24に追従して戻り移動しない。したがって、生体内に検出部材4を留置した状態で、針部材2のみを生体外に抜去することができる。 As described above, even if the slider 24 as the moving portion 62 moves back to the removal moving direction C2 and changes from the state of FIG. 13B to the state of FIG. 13C, it is supported by the support member 26 and the support member 26. The detection member 4 follows the slider 24 and does not return and move. Therefore, only the needle member 2 can be removed from the living body with the detection member 4 indwelling in the living body.

ここで、図13A、図13B、図13Cの移動部62としてのスライダー24の移動は、駆動装置23の回動部23bを周方向の一方向(図13A、図13B、図13Cの斜視では反時計回りの方向)に回動することで実現される。特に、本実施形態の回動部23bは、図13Aの状態から図13Bの状態まで、同極同士の斥力の磁力により回動する。そして、回動部23bは、図13Bの状態まで回動すると、慣性力によりそのまま周方向の一方向(図13A、図13B、図13Cの斜視では反時計回りの方向)に回動する。この慣性力による回動部23bの回動により、異極同士の引力の磁力が大きくなり、回動部23bは、そのまま周方向の一方向(図13A、図13B、図13Cの斜視では反時計回りの方向)に回動し続け、図13Cの状態になる。このように、回動部23bを180度回動させることで、針部材2の挿入及び抜去を連続的に実行することができる。図13Cの状態になると、引力により、固定部23a及び回動部23bの位置関係が安定的に維持される。そのため、収容された針部材2が衝撃等により再び飛び出ることが抑制される。 Here, the movement of the slider 24 as the moving portion 62 of FIGS. 13A, 13B, and 13C is counterclockwise in the circumferential direction of the rotating portion 23b of the drive device 23 (in the perspective of FIGS. 13A, 13B, and 13C). It is realized by rotating in the clockwise direction). In particular, the rotating portion 23b of the present embodiment rotates from the state of FIG. 13A to the state of FIG. 13B by the magnetic force of the repulsive force between the same poles. Then, when the rotating portion 23b rotates to the state shown in FIG. 13B, it rotates in one direction in the circumferential direction (counterclockwise direction in the perspective of FIGS. 13A, 13B, and 13C) as it is due to the inertial force. Due to the rotation of the rotating portion 23b due to this inertial force, the magnetic force of the attractive force between the different poles becomes large, and the rotating portion 23b remains in one direction in the circumferential direction (counterclockwise in the perspective of FIGS. 13A, 13B, 13C). It continues to rotate in the clockwise direction) and reaches the state shown in FIG. 13C. By rotating the rotating portion 23b 180 degrees in this way, the needle member 2 can be continuously inserted and removed. In the state shown in FIG. 13C, the positional relationship between the fixed portion 23a and the rotating portion 23b is stably maintained by the attractive force. Therefore, it is possible to prevent the contained needle member 2 from popping out again due to an impact or the like.

本実施形態のベース部材11は、使い捨て部材である。これに対して、通信装置42を含むカバー部材12は、複数のベース部材11に対して使用される再利用部材である。つまり、ベース部材11は、同一の被検者に対して、所定期間(例えば1週間)だけ使用される。その後、同一被検者が継続して留置装置1を利用する場合には、使用済みのベース部材11は処分され、新たなベース部材11に取り替えられる。カバー部材12は、取り替え前のベース部材11と、取り替え後のベース部材11と、の両方に対して使用される。つまり、使用済みのベース部材11からカバー部材12を取り外し、取り外したカバー部材12を新たなベース部材11に装着することで、留置装置1を再び利用可能な状態にすることができる。 The base member 11 of this embodiment is a disposable member. On the other hand, the cover member 12 including the communication device 42 is a reusable member used for the plurality of base members 11. That is, the base member 11 is used for the same subject for a predetermined period (for example, one week). After that, when the same subject continues to use the indwelling device 1, the used base member 11 is disposed of and replaced with a new base member 11. The cover member 12 is used for both the base member 11 before replacement and the base member 11 after replacement. That is, by removing the cover member 12 from the used base member 11 and attaching the removed cover member 12 to the new base member 11, the indwelling device 1 can be made available again.

このようにすることで、生体内に挿入される針部材2及び検出部材4などの再利用が抑制できると共に、生体内に挿入されず、再利用すべき蓄電部材41、通信装置42などの再利用を実現できる。 By doing so, the reuse of the needle member 2 and the detection member 4 that are inserted into the living body can be suppressed, and the storage member 41, the communication device 42, etc. that are not inserted into the living body and should be reused can be reused. Can be used.

次に、本実施形態の留置装置1の変形例について説明する。図14、図15は、本実施形態の留置装置1の変形例としての留置装置101を示す図である。留置装置101は、上述した留置装置1と比較して、駆動装置の構成が相違しているが、その他の構成は同様である。そのため、ここでは留置装置101の駆動装置123について主に説明し、他の構成については説明を省略する。 Next, a modified example of the indwelling device 1 of the present embodiment will be described. 14 and 15 are views showing a detention device 101 as a modification of the detention device 1 of the present embodiment. The indwelling device 101 is different from the indwelling device 1 described above in the configuration of the driving device, but the other configurations are the same. Therefore, here, the driving device 123 of the indwelling device 101 will be mainly described, and the description of other configurations will be omitted.

図14A、図14B、図14Cは、台座カバー部材22を省略して描いたベース部材111を示す斜視図である。図14Aは、未使用状態の留置装置101におけるベース部材111を示す。図14Bは、図14Aの状態から挿入機構を作動させ、針部材2及び検出部材4を、装着面(留置装置1の装着面3aと同様であるため図2等参照)から最も突出させた状態のベース部材111を示す。図14Cは、図14Bの状態からスライダー24を戻り移動させ、検出部材4を装着面から突出させた状態のまま、針部材2のみを引き戻して内部に収容した状態のベース部材111を示す。 14A, 14B, and 14C are perspective views showing a base member 111 drawn by omitting the pedestal cover member 22. FIG. 14A shows the base member 111 in the indwelling device 101 in an unused state. FIG. 14B shows a state in which the insertion mechanism is operated from the state of FIG. 14A, and the needle member 2 and the detection member 4 are most projected from the mounting surface (see FIG. 2 and the like because they are the same as the mounting surface 3a of the indwelling device 1). The base member 111 of the above is shown. FIG. 14C shows a base member 111 in a state in which the slider 24 is returned and moved from the state of FIG. 14B, and only the needle member 2 is pulled back and housed inside while the detection member 4 is projected from the mounting surface.

図15は、ベース部材111の駆動装置123の詳細を示す図である。より具体的に、図15は、駆動装置123の断面を示す図である。図15に示すように、駆動装置123は、弾性部材123aと、弾性部材123aの弾性力により回動可能なカム部材123bと、を備える。図14A、図14B、図14Cでは、弾性部材123aがカム部材123bにより覆われている。 FIG. 15 is a diagram showing details of the driving device 123 of the base member 111. More specifically, FIG. 15 is a diagram showing a cross section of the drive device 123. As shown in FIG. 15, the drive device 123 includes an elastic member 123a and a cam member 123b that can be rotated by the elastic force of the elastic member 123a. In FIGS. 14A, 14B and 14C, the elastic member 123a is covered with the cam member 123b.

図15に示す弾性部材123aは、ゼンマイバネにより構成されているが、弾性部材123aは、カム部材123bの回動方向に弾性力を蓄えられるような構成であればよく、特に限定されない。図15に示す弾性部材123aとしてのゼンマイバネは、一端が台座部材21の回動軸部21a2に取り付けられ、他端がカム部材123bに係合している。図15に示す弾性部材123aとしてのゼンマイバネは、予め、絞り方向(図14の断面視では時計回り方向)に回動させることで、弾性変形させておく。これにより、弾性部材123aとしてのゼンマイバネには、緩み方向(図14の断面視では反時計回り方向)へカム部材123bを回動させる復元エネルギーが蓄えられる。この復元エネルギーを解放することで、カム部材123bを回動させ、図14A、図14B、図14Cの一連の動作を実現することができる。つまり、留置装置101は、スライダー24(図14A等参照)を、弾性部材123aとしてのゼンマイバネの弾性力により移動方向Cへ移動させる構成である。換言すれば、留置装置101における移動部62としてのスライダー24は、弾性力を用いて針部材2を移動させる。 The elastic member 123a shown in FIG. 15 is composed of a mainspring, but the elastic member 123a is not particularly limited as long as it can store elastic force in the rotation direction of the cam member 123b. One end of the spring as the elastic member 123a shown in FIG. 15 is attached to the rotating shaft portion 21a2 of the pedestal member 21, and the other end is engaged with the cam member 123b. The mainspring as the elastic member 123a shown in FIG. 15 is elastically deformed by rotating it in the drawing direction (clockwise in the cross-sectional view of FIG. 14) in advance. As a result, the mainspring spring as the elastic member 123a stores restoration energy for rotating the cam member 123b in the loosening direction (counterclockwise in the cross-sectional view of FIG. 14). By releasing this restoration energy, the cam member 123b can be rotated to realize a series of operations of FIGS. 14A, 14B, and 14C. That is, the indwelling device 101 is configured to move the slider 24 (see FIG. 14A and the like) in the moving direction C by the elastic force of the mainspring spring as the elastic member 123a. In other words, the slider 24 as the moving portion 62 in the indwelling device 101 moves the needle member 2 by using an elastic force.

本開示に係る留置装置及びベース部材は、上述した実施形態及び変形例に示す具体的な構成に限らず、特許請求の範囲の記載を逸脱しない限り、種々の変形・変更が可能である。 The indwelling device and the base member according to the present disclosure are not limited to the specific configurations shown in the above-described embodiments and modifications, and can be variously modified and modified as long as they do not deviate from the description of the claims.

本開示は留置装置及びベース部材に関する。 The present disclosure relates to an indwelling device and a base member.

1:留置装置
2:針部材
2a:スリット開口
3:装置本体
3a:装着面
4:検出部材
4a:先端側部
4b:基端側部
11:ベース部材
12:カバー部材
21:台座部材
21a:底板部
21a1:係止凸部
21a2:回動軸部
21a3:回動制御凸部
21b:側板部
21b1:開口部
21b2:外面凸部
21b3:当接ガイド部
21c:突出部
21c1:通路
21c2:係合凹部
21a3:回動制御凸部
22:台座カバー部材
23:駆動部材
23a:固定部
23a1:動力磁極部
23a2:湾曲部
23b:回動部
23b1:第1磁極部
23b2:第2磁極部
23b3:長孔
23b4:段差部
23b5:係合軸部
24:スライダー
24a:係合凹部
24a1:内壁
25:針保持部材
26:支持部材
26a:本体部
26a1:挿通孔
26b:第1壁部
26c:第2壁部
27:駆動制御部材
27a:本体部
27b:第1突出板部
27c:第2突出板部
27c1:付勢部
28:回路基板
28a:第1電気接点部
28b:第2電気接点部
29:操作部材
29a:圧縮部
29b:外端部
29c:括れ部
31:係合壁部
32:回動規制部
33:環状シール部材
34:係合部
35:係合凸部
36:湾曲面
37:導線
38:係合部
41:蓄電部材
42:通信装置
42a:制御部
42b:送信部
43:回路基板
43a:電気接点部
44:ハウジング
44a:上面板部
44b:周囲側板部
44b1:切欠部
44b2:内面凹部
50a:作用電極
50b:参照電極
50c:対極
61:ガイド部
62:移動部
70:受け部
101:留置装置
111:ベース部材
123:駆動装置
A:針部材の延在方向
B:厚み方向
C:スライダーの移動方向
C1:挿入移動方向
C2:抜去移動方向
O:針部材の中心軸線
X:内部空間
BS:生体表面
1: Indwelling device 2: Needle member 2a: Slit opening 3: Device main body 3a: Mounting surface 4: Detection member 4a: Tip side 4b: Base end side 11: Base member 12: Cover member 21: Pedestal member 21a: Bottom plate Part 21a1: Locking convex part 21a2: Rotating shaft part 21a3: Rotation control convex part 21b: Side plate part 21b1: Opening 21b2: Outer surface convex part 21b3: Contact guide part 21c: Protruding part 21c1: Passage 21c2: Engagement Recessed portion 21a3: Rotation control convex portion 22: Pedestal cover member 23: Drive member 23a: Fixed portion 23a1: Power magnetic pole portion 23a2: Curved portion 23b: Rotating portion 23b1: First magnetic pole portion 23b2: Second magnetic pole portion 23b3: Length Hole 23b4: Step portion 23b5: Engagement shaft portion 24: Slider 24a: Engagement recess 24a1: Inner wall 25: Needle holding member 26: Support member 26a: Main body portion 26a1: Insertion hole 26b: First wall portion 26c: Second wall Part 27: Drive control member 27a: Main body part 27b: First protruding plate part 27c: Second protruding plate part 27c1: Biasing part 28: Circuit board 28a: First electric contact part 28b: Second electric contact part 29: Operation Member 29a: Compressed portion 29b: Outer end portion 29c: Constricted portion 31: Engaging wall portion 32: Rotation restricting portion 33: Circular sealing member 34: Engaging portion 35: Engaging convex portion 36: Curved surface 37: Conducting wire 38 : Engagement part 41: Power storage member 42: Communication device 42a: Control part 42b: Transmission part 43: Circuit board 43a: Electrical contact part 44: Housing 44a: Top plate part 44b: Peripheral side plate part 44b1: Notch part 44b2: Inner surface recess 50a: Action electrode 50b: Reference electrode 50c: Counter electrode 61: Guide part 62: Moving part 70: Receiving part 101: Indwelling device 111: Base member 123: Drive device A: Needle member extending direction B: Thickness direction C: Slider Movement direction C1: Insertion movement direction C2: Removal movement direction O: Central axis of needle member X: Internal space BS: Living body surface

Claims (10)

生体に装着される装着面を備える装置本体と、
針部材と、を備え、
前記装置本体は、前記針部材を前記装着面から突出させることで前記生体内に前記針部材を挿入する挿入機構を備え、
前記挿入機構は、前記針部材に当接し、前記針部材の中心軸線を含む面内で前記針部材を回動させるガイド部を備える留置装置。
The main body of the device, which has a mounting surface to be mounted on the living body,
With a needle member,
The apparatus main body includes an insertion mechanism for inserting the needle member into the living body by projecting the needle member from the mounting surface.
The insertion mechanism is an indwelling device including a guide portion that comes into contact with the needle member and rotates the needle member in a plane including the central axis of the needle member.
前記挿入機構は、前記針部材を所定の一方向に移動させることが可能な移動部を備え、
前記ガイド部は、前記移動部により移動している前記針部材に当接し、前記中心軸線を含む面内で前記針部材を回動させ、前記針部材の先端の進行方向を前記所定の一方向から変化させる、請求項1に記載の留置装置。
The insertion mechanism includes a moving portion capable of moving the needle member in a predetermined direction.
The guide portion abuts on the needle member moving by the moving portion, rotates the needle member in a plane including the central axis, and sets the traveling direction of the tip of the needle member in the predetermined one direction. The indwelling device according to claim 1, which is changed from.
前記針部材の基端部は、前記針部材が前記移動部により前記所定の一方向に移動しているときに、前記移動部に対して、前記所定の一方向と直交する方向に移動可能である、請求項2に記載の留置装置。 The base end portion of the needle member can move in a direction orthogonal to the predetermined one direction with respect to the moving portion when the needle member is moving in the predetermined one direction by the moving portion. The indwelling device according to claim 2. 前記ガイド部は、前記所定の一方向と略直交し、前記装着面に向かう方向に、前記針部材の前記先端の進行方向を変化させる、請求項2又は3に記載の留置装置。 The indwelling device according to claim 2 or 3, wherein the guide portion is substantially orthogonal to the predetermined one direction and changes the traveling direction of the tip of the needle member in a direction toward the mounting surface. 前記ガイド部は、前記中心軸線を含む断面において、前記所定の一方向に向かうにつれて前記装着面に近づくように延在する円弧状の湾曲面により構成されている、請求項2乃至4のいずれか1つに記載の留置装置。 Any of claims 2 to 4, wherein the guide portion is formed of an arcuate curved surface extending so as to approach the mounting surface toward the predetermined one direction in a cross section including the central axis. The indwelling device according to one. 前記生体内に挿入され、前記生体内の被計測物質を検出可能な検出部材と、
前記検出部材を支持する支持部材と、を備え、
前記挿入機構の移動部は、前記針部材を前記所定の一方向とは逆方向に戻り移動させることが可能であり、
前記針部材が前記挿入機構の前記移動部により前記所定の一方向に移動する場合に、前記検出部材及び前記支持部材は、前記検出部材が前記針部材の内部に延在する状態で、前記針部材と共に前記所定の一方向に移動し、かつ、前記針部材と共に前記挿入機構の前記ガイド部により回動することで、前記針部材が前記逆方向に戻り移動する際に追従して移動しない姿勢へと変化する、請求項2乃至5のいずれか1つに記載の留置装置。
A detection member that is inserted into the living body and can detect the substance to be measured in the living body,
A support member that supports the detection member is provided.
The moving portion of the insertion mechanism can move the needle member back in a direction opposite to the predetermined one direction.
When the needle member is moved in the predetermined direction by the moving portion of the insertion mechanism, the detection member and the support member are in a state where the detection member extends inside the needle member. A posture in which the needle member moves in a predetermined direction together with the member and is rotated by the guide portion of the insertion mechanism together with the needle member so that the needle member does not follow and move when returning and moving in the opposite direction. The indwelling device according to any one of claims 2 to 5, which changes to.
前記挿入機構の前記移動部は、磁力又は弾性力を用いて前記針部材を移動させる、請求項2乃至6のいずれか1つに記載の留置装置。 The indwelling device according to any one of claims 2 to 6, wherein the moving portion of the insertion mechanism moves the needle member by using a magnetic force or an elastic force. 前記針部材は円弧状に湾曲して延在する円弧針である、請求項1乃至7のいずれか1つに記載の留置装置。 The indwelling device according to any one of claims 1 to 7, wherein the needle member is an arc needle that is curved in an arc shape and extends. 生体に装着される装着面を備える装置本体と、
針部材と、を備え、
前記装着本体は、前記針部材を前記装着面から突出させることで前記生体内に挿入する挿入機構を備え、
前記挿入機構は、前記針部材を所定の一方向、及び、前記所定の一方向の逆方向、に移動させることが可能な移動部を備え、
前記移動部は、引力及び斥力の一方の磁力により、前記針部材を前記所定の一方向に移動させ、他方の磁力により、前記針部材を前記逆方向に移動させる留置装置。
The main body of the device, which has a mounting surface to be mounted on the living body,
With a needle member,
The mounting body includes an insertion mechanism that inserts the needle member into the living body by projecting the needle member from the mounting surface.
The insertion mechanism includes a moving portion capable of moving the needle member in a predetermined one direction and the opposite direction of the predetermined one direction.
The moving portion is an indwelling device that moves the needle member in the predetermined one direction by one magnetic force of attractive force and repulsive force, and moves the needle member in the opposite direction by the other magnetic force.
通信装置を含むカバー部材を取り付け可能であると共に、生体に装着される装着面を備えるベース部材であって、
針部材と、
前記針部材を前記装着面から突出させることで前記針部材を前記生体内に挿入する挿入機構と、を備え、
前記挿入機構は、前記針部材に当接し、前記針部材の中心軸線を含む面内で前記針部材を回動させるガイド部を備えるベース部材。
A base member to which a cover member including a communication device can be attached and which has a mounting surface to be mounted on a living body.
Needle member and
An insertion mechanism for inserting the needle member into the living body by projecting the needle member from the mounting surface is provided.
The insertion mechanism is a base member including a guide portion that comes into contact with the needle member and rotates the needle member in a plane including the central axis of the needle member.
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