WO2012067115A1 - センサシステム、およびセンサシステムの使用方法 - Google Patents
センサシステム、およびセンサシステムの使用方法 Download PDFInfo
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- WO2012067115A1 WO2012067115A1 PCT/JP2011/076306 JP2011076306W WO2012067115A1 WO 2012067115 A1 WO2012067115 A1 WO 2012067115A1 JP 2011076306 W JP2011076306 W JP 2011076306W WO 2012067115 A1 WO2012067115 A1 WO 2012067115A1
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- Prior art keywords
- sensor
- needle
- needle assembly
- living body
- guide needle
- Prior art date
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
- A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
- A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- A—HUMAN NECESSITIES
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- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/15003—Source of blood for venous or arterial blood
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6832—Means for maintaining contact with the body using adhesives
- A61B5/6833—Adhesive patches
Definitions
- the present invention relates to a sensor system that continuously measures an analyte component in a living body and a method of using the sensor system.
- a sensor system that measures an analyte component (body fluid component) with a sensor placed in a living body is widely known.
- a sensor is inserted into a guide needle that is punctured into a living body, and the sensor is embedded in the body together with the puncture of the guide needle.
- a signal transmitted according to the analyte component detected by the sensor is received by an electronic circuit such as a transmitter, and information based on the received content can be transmitted to the user.
- Patent Document 1 discloses a sensor system in which a sensor system main body and an electronic device unit including an electronic circuit are provided separately (see Patent Document 1). A configuration is adopted in which the electronic device unit is attached to the sensor system main body after the guide needle is punctured, and the electronic device unit is attached while the user visually confirms the attachment position.
- the present invention has been made in order to solve the above-described problem, and improves the workability of installation work for installing a sensor on a living body, thereby improving user convenience, and a method of using the sensor system
- the purpose is to provide.
- a sensor system of the present invention includes a sensor that detects an analyte component of a living body and transmits a signal, a sensor member that includes a holding unit that holds the sensor, and is detachably attached to the sensor member.
- a signal processing circuit member including a needle assembly including a guide needle that is attached and guides insertion of the sensor into a living body, and an electronic circuit that is detachably attached to the sensor member and processes the signal from the sensor.
- a fixing member that fixes the sensor member to the skin of the living body, and the sensor is installed on the living body with the signal processing circuit member attached to the sensor member.
- a series of sensors are installed on a living body in a state where a signal processing circuit member including an electronic circuit for processing a signal is attached to the sensor member including the sensor. Since the operation can be performed, it is not necessary to perform the operation of attaching the signal processing circuit member after the puncturing operation of the guide needle. For this reason, even when the sensor is installed on the body surface portion that is difficult for the user to visually observe, the work of installing the signal processing circuit member is not complicated, and the workability of the sensor installation work is improved. Therefore, the convenience of the user who uses the sensor system can be improved.
- FIG. 1 is an external perspective view of a sensor system according to an embodiment.
- 2A and 2B are external perspective views of the signal processing circuit member, wherein FIG. 2A is a perspective view seen from the back side where the sensor members are arranged to face each other, and FIG. 2B is a perspective view seen from the front side. is there.
- 3A and 3B are external perspective views of the sensor member, in which FIG. 3A is a perspective view seen from the rear surface side facing the living body, and FIG. 3B is a perspective view seen from the front surface side.
- 4A and 4B are diagrams showing the sensor member in a simplified manner, where FIG. 4A is a plan view seen from the front surface side, FIG. 4B is a view seen from the direction of arrow 4B in FIG.
- FIG. 5A and 5B are diagrams for explaining the configuration of the sensor according to the embodiment, in which FIG. 5A is an enlarged plan view showing a broken line portion 5A in FIG. 4C, and FIG. It is a side view which shows an example.
- 6A and 6B are external perspective views of the needle assembly, wherein FIG. 6A is a perspective view showing a state before the sensor member is attached, and FIG. 6B is a perspective view showing a state after the sensor member is attached.
- . 7A and 7B are views for explaining the needle assembly, in which FIG. 7A is an arrow view seen from the direction of the arrow 7A in FIG. 6B, and FIG. 7B is a broken line portion in FIG.
- FIG. 8 is a diagram for explaining a procedure for housing the sensor in the internal space of the guide needle.
- FIG. 8A is a diagram illustrating a state before the sensor is housed in the guide needle.
- a partially enlarged view (B) is a partially enlarged view of the back side of the sensor member showing a state after the sensor is accommodated in the guide needle
- (C) is a view for explaining the function of the slit of the guide needle. It is a figure of this, and is the arrow line view seen from the arrow 8C direction of (B).
- FIG. 9 is a cross-sectional view taken along the line 9A-9A ′ in FIG.
- FIGS. 10A and 10B are cross-sectional views illustrating combinations of the cross-sectional shape of the guide needle and the cross-sectional shape of the sensor.
- FIGS. 11A to 11C are diagrams for explaining the angle adjustment structure of the movable part, and are simplified views of the arrow viewed from the direction of the arrow 11A in FIG.
- FIGS. 12A and 12B are views for explaining a procedure for separating the sensor member and the signal processing circuit member, and are diagrams showing the section taken along the line 12A-12A ′ in FIG. 1 in a simplified manner.
- It is. 13A and 13B are diagrams showing the sensor member and the cover material in a simplified manner, where FIG. 13A is a plan view seen from the front surface side, and FIG.
- FIG. 13B is an arrow view seen from the direction of arrow 14B in FIG. (C) is the top view seen from the back surface side.
- FIGS. 14A to 14C are views for explaining the adhesive portion and the peeling member, and are perspective views of the connected needle assembly and the sensor member as seen from the back side.
- 15A and 15B are diagrams for explaining the operation of the sensor system according to the embodiment.
- FIG. 15A is a perspective view for explaining the operation of attaching the signal processing circuit member to the sensor member
- FIG. It is a perspective view which shows the state after attaching a processing circuit member.
- 16A and 16B are diagrams for explaining the operation of the sensor system according to the embodiment, and FIG.
- FIG. 16A is a perspective view showing a state before removing a peeling member that covers an adhesive portion provided on the movable portion
- FIG. These are perspective views which show the state after removing the peeling member which covers the adhesion part provided in the movable part.
- 17A and 17B are diagrams for explaining the operation of the sensor system according to the embodiment.
- FIG. 17A is a perspective view for explaining the operation of rotating the movable portion
- FIG. (C) is a perspective view for demonstrating the operation
- 18A and 18B are views for explaining the operation of the sensor system according to the embodiment, in which FIG.
- FIG. 18A is a perspective view illustrating a state in which the fixation between the needle assembly and the sensor member is released, and FIG. It is a perspective view for demonstrating the operation
- 19A and 19B are diagrams for explaining the operation of the sensor system according to the embodiment.
- FIG. 19A is a perspective view illustrating a state after the needle assembly is detached from the sensor member, and
- FIG. 19B is a sensor member. It is a perspective view which shows the state which was fixed with respect to skin. It is sectional drawing which shows the sensor and guide needle
- sensor system 100 detects an analyte component in the living body over time by a sensor inserted and embedded in the living body, and detects the analyte component as signal processing circuit member 310.
- This is a sensor device that enables measurement and analysis by an electronic circuit 311 included in the communication device and allows a measurement result to be transmitted to a user.
- the analyte component is, for example, glucose contained in the interstitial fluid, and the sensor system 100 uses the glucose concentration as a measurement target, and enables the measurement result to be transmitted to a diabetic patient who is a user.
- Examples of the analyte component to be measured include biological components such as lactic acid in addition to glucose.
- the measurement target is not limited to components in the living body, and for example, the sensor system 100 can be applied as a sensor for indicating a physiological state such as a pH value.
- the sensor member 110 includes a sensor 120 that detects an analyte component of a living body and transmits a signal, and a holding unit 130 that holds the sensor 120. (See also FIG. 3), a needle assembly 210 that is detachably attached to the sensor member 110 and includes a guide needle 220 that guides the insertion of the sensor 120 into the living body (FIGS. 6 and 17B). 2), a signal processing circuit member 310 that is detachably attached to the sensor member 110 and includes an electronic circuit 311 that processes a signal from the sensor 120 (see also FIG. 2), and the sensor member 110 is attached to the living body skin s. And a fixing member 350 (see also FIG. 13 and FIG. 14).
- the sensor system 100 can install the sensor 120 on the living body with the signal processing circuit member 310 attached to the sensor member 110 (see also FIGS. 19A and 19B). ).
- the signal processing circuit member 310 includes a substantially rectangular case 313 in which an electronic circuit 311 is accommodated.
- the case 313 can be manufactured using, for example, hard plastic that can prevent liquid from penetrating and permeating, metal, ceramic, and the like.
- the hard plastic for example, ABS resin, polypropylene, polycarbonate, polystyrene, or the like can be used.
- the metal for example, titanium or SUS316 can be used, and as the ceramic, for example, zirconia can be used.
- the external dimensions can be designed in various sizes depending on the function to be added, but for example, those having a width of 10 mm to 50 mm, a depth of 10 mm to 50 mm, and a thickness of about 1 mm to 10 mm should be used. Is possible.
- Fitting ribs 315 a and 315 b for connecting to the sensor member 110 are provided on the back surface of the case 313.
- the back surface of the case 313 is a surface on the side where the sensor member 110 is arranged to face each other (see FIG. 12).
- the electronic circuit 311 provided in the signal processing circuit member 310 receives a signal transmitted from the sensor 120 provided in the sensor member 110 and performs a predetermined process based on the content of the signal.
- the signal transmitted from the sensor 120 is once taken into the electronic circuit 160 disposed in the main body 140 provided in the holding unit 130 that constitutes the housing of the sensor member 110, and then processed.
- the processed signal is transmitted to the electronic circuit 311 disposed in the processing circuit member 310 (see FIG. 3A).
- a conventionally known technique can be adopted for the communication method between the electronic circuit 311 on the signal processing circuit member 310 side and the electronic circuit 160 on the sensor member 110 side.
- a conventionally known technique can be adopted.
- electromagnetic induction using a dielectric coil
- radio waves an optical communication method using an LED and a photodiode installed so as to face the LED.
- An electrical connection method can be adopted when sufficient measures against electric leakage are taken.
- signals can be transmitted and received by a general communication method using electrical signals.
- the sensor member 110 includes a sensor 120, a holding unit 130 that holds the sensor 120, and an electronic circuit 160 that is accommodated in the holding unit 130.
- the sensor 120 is accommodated in a groove-shaped concave guide 131 provided in the holding unit 130.
- the concave guide 131 is formed along the longitudinal direction on the back surface 111 of the sensor member 110.
- the back surface 111 of the sensor member 110 is a surface on the side disposed facing the skin s of the living body when the sensor 120 is installed (see FIG. 17B).
- the sensor member 110 is prepared in a state of being connected to the needle assembly 210 prior to the installation of the sensor 120 on the living body (see FIG. 15A).
- the guide needle 220 for guiding the insertion of the sensor 120 and the sensor 120 are assembled (see FIG. 8B).
- the holding part 130 of the sensor member 110 includes a main body part 140 that covers and holds the proximal end part 221 side of the guide needle 220 and a movable part that covers and holds the needle part 225 formed on the distal end part 223 side of the guide needle 220.
- 150 and a hinge (corresponding to a connecting member) 133 that connects the main body 140 and the movable portion 150 so as to be rotatable about an axial direction intersecting the long axis direction of the guide needle 220.
- the holding unit 130 can be manufactured using, for example, the same material as that constituting the case 313 of the signal processing circuit member 310, and can be appropriately selected from hard plastic, metal, ceramic, and the like.
- the guide needle 220 is accommodated in the concave guide 131 of the sensor member 110, and the sensor 120 is accommodated in the guide needle 220 (FIGS. 8A and 8B). )).
- the base end 221 side of the guide needle 220 is held in the main body 140 provided in the holding unit 130.
- the needle portion 225 formed on the distal end portion 223 side of the guide needle 220 is held by the movable portion 150 provided in the holding portion 130.
- the needle portion 225 of the guide needle 220 can be exposed by rotating the movable portion 150 via the hinge 133 from the state where the guide needle 220 is held by the holding portion 130 (FIG. 3B and FIG. 3). 17 (A) shows rotation by an arrow r). Further, the needle portion 225 of the guide needle 220 is rotated from the state where the needle portion 225 of the guide needle 220 is exposed to the direction opposite to the direction of rotation when the guide needle 220 is exposed, thereby moving the needle portion 225 of the guide needle 220 to the movable portion 150. It is possible to cover and shield by.
- the main body 140 of the sensor member 110 is connected to the fitting ribs 141 a and 141 b for connecting to the signal processing circuit member 310, the slide rail 143 for connecting to the needle assembly 210, and the needle assembly 210. And a locking recess 145 for fixing.
- An electronic circuit 160 that transmits and receives signals to and from the sensor 120 is prepared by being accommodated in advance in the main body 140.
- the slide rail 143 is provided so as to be fitted into the slide guide 250 of the needle assembly 210.
- the sensor member 110 can be slid and connected to the needle assembly 210 (indicated by an arrow a in FIG. 6B).
- the shape and the number of installation of the slide rail 143 are not particularly limited, and are appropriately selected as long as the mounting operation of the sensor member 110 and the needle assembly 210 and the accommodation of the sensor 120 in the guide needle 220 can be smoothly performed. It is possible to change.
- the locking recess 145 is a portion into which the locking protrusion 261 of the needle assembly 210 is fitted (see FIGS. 4A and 6A).
- a lock member 260 is constituted by the lock recess 145 and the lock protrusion 261.
- the movable portion 150 is provided with a protrusion 151 for adjusting the rotation angle of the movable portion 150.
- the protrusion 151 is used in combination with the angle adjustment structure 270 provided on the needle assembly 210 (see FIG. 11).
- the sensor 120 has a long outer shape that can be accommodated in the concave guide 131 of the sensor member 110.
- the sensor 120 is held by the holding unit 130 in a state of being electrically connected to the electronic circuit 160 housed in the main body 140 via the circuit introduction unit 125 (see FIG. 8C).
- the sensor 120 when the sensor 120 performs communication without an electrical contact such as a magnetic field between the sensor member 110 and the signal processing member 310, the sensor 120 outputs a signal corresponding to the detected analyte component as necessary. Transmission to the electronic circuit 160 housed inside the member 110 is possible.
- the electronic circuit 160 includes a microcomputer as necessary, and after a predetermined process is performed by the microcomputer, a signal is transmitted to the signal processing circuit member 310 attached to the sensor member 110.
- the electronic circuit 311 included in the signal processing circuit member 310 processes the received signal and transmits a measurement result corresponding to the signal to the user.
- a method of transmitting the measurement result to the user a method of visually transmitting information using a display or the like, a method of transmitting information audibly by an alarm, or the like can be appropriately employed.
- the sensor probe 123 generates a signal corresponding to the presence of the analyte component of the living body and its concentration.
- the sensor probe 123 can be appropriately selected from various types according to the analyte component. For example, when measuring the glucose concentration using glucose oxidase (GOD), it is possible to use an oxidation-reduction electrode in which GOD is fixed to the electrode. In addition, it is possible to adopt a form using a fluorescent dye that emits fluorescence by binding to glucose or reduces fluorescence. In addition, it is possible to employ a configuration in which a physical quantity such as temperature is measured by an analysis semiconductor chip or the like and a predetermined signal is generated based on the measurement result.
- GOD glucose oxidase
- the size of the sensor probe 123 can be appropriately changed according to the analyte component to be measured and the means for extracting the signal.
- the cross-sectional dimension is preferably 3 mm ⁇ 3 mm or less.
- the cross-sectional dimension is more preferably 0.05 mm ⁇ 0.05 mm to 1 mm ⁇ 1 mm.
- the length is preferably about 0.1 mm to 20 mm, for example.
- a conductor for transmitting an electrical signal can be disposed inside the sensor 120.
- the conductor is wired from the sensor probe 123 to the electronic circuit 160 disposed inside the sensor member 110 via the sensor lead part 121 and the circuit introduction part 125.
- the conductor for example, a bundle of copper wires having a relatively small diameter can be used, or a conductor formed by printing on a flexible polyimide film can be used.
- FIG. 5B shows an optical waveguide core 126 made of glass, acrylic, cyclic polyolefin, etc., an optical waveguide clad 127 made of a fluororesin having a refractive index lower than that of the optical waveguide core 126, the optical waveguide core 126, and the optical waveguide cladding.
- diffused reflection surface 128 diffusely reflects light generated from the circuit portion and light generated from the dye, and is disposed so as to face the diffused reflection surface 128 with the optical waveguide cladding 127 interposed therebetween.
- a sensor 120 connected to a layer of dye 129 that interacts with a light component.
- the irregular reflection surface 128 is manufactured, for example, by scraping off the tip of the optical waveguide clad 127 so as to have irregularities, and sputtering or plating or adhering an irregular reflection member having a high light reflectance such as aluminum.
- the thickness t2 of the portion corresponding to the sensor probe portion can be made larger than the thickness t1 of the middle portion from the sensor lead portion to the circuit introduction portion.
- the needle assembly 210 is formed with a guide needle 220 and a notch 231 that accommodates the proximal end portion 221 side of the guide needle 220 and exposes a part of the guide needle 220.
- An angle adjustment structure 270 for performing adjustment, a lever 280 for releasing fixation between the fixed needle assembly 210 and the sensor member 110, and a process for releasing fixation can be performed smoothly.
- an elastically deformable flexible portion 281 provided.
- the guide needle 220 includes a needle portion 225 formed in a sharp end shape for smoothly performing a puncturing operation for inserting the guide needle 220 into the living body, an open end 226 formed in the distal end portion 223, and a sensor. It has an internal space 227 that accommodates 120 in a movable manner, and a slit 228 that extends from the opening end 226 along the long axis direction (see FIGS. 7B and 8).
- a general puncture needle made of stainless steel used for medical purposes and having a slit 228 formed is used as the guide needle 220.
- connection and separation between the sensor member 110 and the needle assembly 210 are performed by sliding both the members 110 and 210 relative to each other.
- slide rail 143 provided on the sensor member 110 side and the slide guide 250 provided on the needle assembly 210 side it is possible to easily and smoothly perform connection and separation operations by slide movement. Yes.
- connection between the sensor member 110 and the needle assembly 210 is performed by sliding the sensor member 110 with respect to the needle assembly 210 along the arrow a in FIG.
- the slide rail 143 of the sensor member 110 is fitted while being guided by the slide guide 250 of the needle assembly 210.
- the sensor 120 is accommodated in the internal space 227 through the open end 226 of the guide needle 220 while being held by the holding portion 130 of the sensor member 110 (see FIGS. 8A and 8B).
- the locking recess 145 provided on the main body 140 of the sensor member 110 and the locking protrusion 261 of the needle assembly 210 are fitted together, so that the sensor member 110 and the needle assembly 210 are fixed. .
- Separation of the sensor member 110 and the needle assembly 210 is performed by sliding the needle assembly 210 with respect to the sensor member 110 along the arrow a ′ in FIG. 6B (FIG. 18B). See also).
- the lever 280 is pushed in along the arrow b in FIG. 6B (see also FIG. 18A).
- the locking protrusion 261 provided on the needle assembly 210 is extracted from the inside of the locking recess 145 provided on the sensor member 110, and the sensor member 110 and the needle assembly.
- the fixation with 210 is released. By releasing the fixation, the needle assembly 210 can be slid relative to the sensor member 110.
- the sensor member 110 and the needle assembly 210 are separated, and the sensor 120 is pulled out from the internal space 227 of the guide needle 220.
- the separation operation of the needle assembly 210 is performed, so that only the sensor 120 is placed under the skin of the living body.
- the guide is provided when the sensor member 110 and the needle assembly 210 are connected or separated. It is possible to prevent the needle 220 and the sensor 120 from being bent or caught. It is possible to smoothly house the sensor 120 in the guide needle 220 and remove the guide needle 220 from the living body.
- the circuit introduction part 125 of the sensor 120 is inserted into a slit 228 formed in the guide needle 220 (see FIG. 8C).
- the sensor member 110 and the needle assembly 210 are slid while the circuit introduction part 125 is guided by the slit 228. Since the circuit introduction portion 125 of the sensor 120 and the guide needle 220 are prevented from interfering with each other during the slide movement, connection and separation work by the slide movement can be performed smoothly.
- An attached member 282 can be appropriately attached to the lever 280 as shown by a broken line in FIG.
- the user can perform the work of releasing the fixation using either one of the left and right hands, or both the left and right hands. Thereby, the workability
- separation work can be improved further.
- the needle portion 225 formed at the tip of the guide needle 220 is disposed so as to be exposed from the convex guide 230 of the needle assembly 210.
- the exposed length at which the guide needle 220 is exposed from the convex guide 230 is, for example, preferably about 1 mm to 30 mm, and more preferably about 5 mm to 10 mm. With the exposure length set in this way, the guide needle 220 can be inserted into the skin, under the skin, or the like, and the exposure length becomes the puncture depth of the guide needle 220 into the living body.
- FIG. 9 an enlarged cross-sectional view around the circuit introduction part 125 of the sensor 120 is shown.
- the state where the sensor 120 is accommodated in the guide needle 220 in which the slit 228 is formed is shown.
- the circuit introduction part 125 of the sensor 120 is led out from the slit 228 of the guide needle 220 and arranged.
- the electronic circuit 160 housed in the main body portion 140 of the holding portion 130 that constitutes the housing of the sensor member 110 and the circuit introduction portion 125 of the sensor 120 It is possible to maintain the electrical connection with.
- a return 229 is formed on the guide needle 220 at a portion where the sensor probe 123 of the sensor 120 is disposed.
- a return 229 is formed on the guide needle 220, and the thickness t2 of the sensor probe 123 is formed larger than the slit width h of the guide needle 220 (h ⁇ t2), thereby preventing the sensor 120 from falling out of the guide needle 220.
- the return 229 of the guide needle 220 is partially formed at a position where the sensor lead part 121 of the sensor 120 is arranged, a place where the circuit introduction part 125 of the sensor 120 is arranged, or in the major axis direction of the guide needle 220. It is also possible to form it over the entire length.
- the slit width h of the guide needle 220 can be appropriately changed according to the outer shape of the guide needle 220 and the like, but for example, it is preferably formed to about 0.04 mm to 2.9 mm.
- the thickness t2 of the sensor probe 123 is preferably formed to be, for example, about 0.05 mm to 3.0 mm.
- the thickness t1 of the sensor lead portion 121 is formed to about 0.01 mm to 2.8 mm, for example.
- the return 229 is formed only in the vicinity of the position where the sensor probe 123 is disposed in the guide needle 220, and the portion (t3 ⁇ It is possible to adopt a configuration in which h) is formed in the circuit introduction part 125 of the sensor 120. By adopting such a configuration, the circuit introduction part 125 can be led out of the guide needle 220 while preventing the sensor probe 123 from falling out of the guide needle 220. It is not necessary to form the return 229 along the entire length. For example, by using a combination of the sensor 120 having the size shown in FIG. 10B and the guide needle 220 having the shape shown in FIG. It is possible to suitably prevent the dropout.
- the movable unit 150 is lifted around the hinge 133 from the state before the movable unit 150 is rotated.
- the sensor member 110 and the signal processing circuit member 310 are formed in the signal processing circuit member 310 with respect to the fitting ribs 141 a and 141 b formed at a position sandwiching the concave guide 131 of the sensor member 110.
- the fitting ribs 315a and 315b are connected by fitting.
- the members 110 and 310 are difficult to separate from each other. That is, it is possible to suitably prevent the sensor member 110 and the signal processing circuit member 310 from being inadvertently separated in a state where the sensor system 100 is fixed to the living body skin s. .
- the sensor member 110 and the signal processing circuit member 310 are separated, the sensor member 110 is deformed so that a part of the sensor member 110 in the vicinity of the fitting ribs 141a and 141b is bent starting from the concave guide 131 of the sensor member 110 (see FIG. 12 (B)). Thereby, the signal processing circuit member 310 can be easily removed. Since the electronic circuit 160 for processing and transmitting the signal transmitted from the sensor 120 is built in the sensor member 110, it is difficult to greatly deform the entire sensor member 110. In the concave guide 131 formed in the main body 140 of the sensor member 110 and the movable portion 150 of the sensor member 110, the sensor 120 that can be flexibly deformed is disposed with a gap therebetween.
- the shape and the number of the fitting ribs 141a and 141b formed on the sensor member 110 and the fitting ribs 315a and 315b formed on the signal processing circuit member 310 are not particularly limited, and can be appropriately changed.
- two fitting ribs 141a, 141b, 315a, and 315b are prepared in pairs, respectively, so that the positional relationship at the time of connection of the sensor member 110 and the signal processing circuit member 310 is constant every time the connection is made, and Each shape is different.
- the fitting ribs 141a and 141b and the fitting ribs 315a and 315b are formed in different sizes.
- the arrow in FIG. As shown in the figure, if the signal processing circuit member 310 is peeled upward while pressing the end of the sensor member 110 downward, the separation work can be easily performed without taking time and effort.
- a fixing member 350 for fixing the sensor member 110 to the skin s of the living body includes a first adhesive portion 351 provided on the back surface of the main body portion 140 included in the sensor member 110.
- the back surface of the main body portion 140 and the back surface of the movable portion 150 are the surface on the side that faces the living body skin s when the sensor system 100 is installed, that is, the surface located on the back surface 111 side of the sensor member 110. (See FIG. 17B).
- the sensor-side peeling member 360 includes a first peeling piece 361 attached to the first bonding portion 351 and a second peeling piece 362 that is separated from the first peeling piece 361 and attached to the second bonding portion 352.
- the first adhesive portion 351 and the second adhesive portion 352 are configured by attaching a base material having an adhesive surface formed using a known adhesive capable of adhering to a living body to the back surface 111 of the sensor member 110. ing.
- the 1st peeling piece 361 and the 2nd peeling piece 362 are comprised by the well-known peeling member in which the peeling layer arrange
- the first adhesive part 351 is exposed by removing the first peeling piece 361.
- the main body part 140 is fixed to the living body by bringing the back surface of the main body part 140 into contact with the skin s of the living body in an exposed state (see FIG. 18B).
- the movable part 150 is fixed to the living body by removing the second peeling piece 362 and bringing the back surface of the movable part 150 into contact with the living body skin s with the second adhesive part 352 exposed. (See FIG. 17B).
- the peeling of the first peeling piece 361 and the peeling of the second peeling piece 362 can be performed independently.
- the movable portion 150 is pressed against the skin s (see FIG. 16B), so that the second strip 362 is stripped in advance prior to the puncturing operation.
- the movable portion 150 can be fixed to the skin s together with the puncturing operation.
- the second peeling piece 362 attached to the back surface of the movable portion 150 is disposed so as to cover the concave guide 131 provided on the back surface of the movable portion 150, the needle portion 225 of the guide needle 220 before the puncturing operation. Can be prevented from projecting from the inside of the concave guide 131, and safety during use can be improved. Further, it is possible to prevent the sensor 120 held in the concave guide 131 from being contaminated.
- the first peeling piece 361 has a sensor side tongue 363 for connecting the first peeling piece 361 to the needle assembly 210.
- the sensor-side tongue 363 is formed by extending a part of the peeling member, and one end thereof is attached to the needle assembly 210 (see FIG. 14A).
- the sensor side tongue 363 is pulled in the movement direction of the needle assembly 210 in conjunction with the sliding movement of the needle assembly 210 (arrow a 'in FIG. 14A). Indicates slide movement).
- the first peeling piece 361 is peeled from the first adhesive portion 351 through the sensor side tongue 363.
- the fixing member 350 includes an outer peripheral portion 371 disposed so as to protrude from the sensor member 110, and is provided on a cover material 370 that covers the outer surface of the sensor member 110, and a surface disposed facing the living body in the outer peripheral portion 371. It has a cover material side adhesive portion 372 and a cover material side peeling member 373 that covers the cover material side adhesive portion 372 and is detachably attached (see FIG. 14C).
- the cover member 370 is prepared in a state where it is adhered to the surface of the sensor member 110 in order to prevent the cover member 370 from being detached from the sensor member 110.
- a soft resinous film such as polyester, polyurethane, polyethylene, or nylon can be used.
- the cover material side adhesive portion 372 is formed of the same material as the first adhesive portion 351 and the second adhesive portion 352 described above.
- the cover material side peeling member 373 is formed of the same material as the sensor side peeling member 360 described above.
- the cover material side peeling member 373 has a cover material side tongue 374 for connecting the cover material side peeling member 373 to the needle assembly 210 (see FIG. 14C).
- the cover material side tongue 374 is formed by extending a part of the peeling member, and one end thereof is attached to the needle assembly 210.
- the cover material side tongue 374 is pulled in the movement direction of the needle assembly 210 in conjunction with the movement of the needle assembly 210 (arrow a 'in FIG. 14C). Indicates slide movement).
- the cover material side peeling member 373 is peeled from the cover material side adhesive portion 372 via the cover material side tongue 374.
- the first adhesive portion 351 provided in the main body 140, the second adhesive portion 352 provided in the movable portion 150, and the cover material side adhesive portion 372 provided in the cover material 370 are respectively provided. It functions as the fixing member 350.
- the sensor system 100 is distributed as a product in a state in which the first peeling piece 361, the second peeling piece 362, and the cover material-side peeling member 373 are attached in advance.
- sensor system 100 is prepared with sensor member 110 and needle assembly 210 attached.
- the signal processing circuit member 310 Prior to the puncturing operation of the guide needle 220, the signal processing circuit member 310 is attached to the sensor member 110.
- the sensor member 110, the needle assembly 210, and the signal processing circuit member 310 are integrated.
- the second peeling piece 362 covering the second adhesive portion 352 provided on the back surface of the movable portion 150 is removed (indicated by an arrow in the drawing). Since the needle part 225 of the guide needle 220 is held in a shielded state until the movable part 150 is rotated, the sensor system 100 can be handled safely.
- the movable portion 150 of the sensor member 110 is rotated using the hinge 133 (rotation is indicated by an arrow r in the figure).
- the needle part 225 of the guide needle 220 is exposed with the rotation.
- the puncture operation can be prepared by a simple operation of rotating the movable portion 150.
- the protrusion part 151 provided in the movable part 150 is arrange
- the movable part 150 can be caused to be perpendicular to the surface direction of the main body part 140 of the sensor member 110.
- the user punctures the skin s with the guide needle 220 while holding the sensor system 100 with the finger of one hand.
- the puncture operation can be performed by a simple operation of pressing the movable portion 150 against the skin s while visually observing the needle portion 225 and the puncture position of the guide needle 220.
- the sensor 120 can be installed in the target site.
- the movable part 150 is fixed to the skin s via the second adhesive part 352.
- the lock member 260 is released by pushing down the lever 280 in the direction of arrow b and lifting the locking projection 261 in the direction of arrow b ′ via the flexible portion 281 connected to the lever 280.
- the needle assembly 210 and the sensor member 110 are not fixed, and the needle assembly 210 can be slid relative to the sensor member 110.
- the user slides the needle assembly 210 while holding the needle assembly 210 with the finger of one hand (indicated by arrow a ′ in the figure).
- the guide needle 220 is removed from the skin s by the sliding movement of the needle assembly 210. Since the slide movement is performed along the long axis direction of the guide needle 220, there is no possibility that the guide needle 220 is bent and caught, and the guide needle 220 can be smoothly removed.
- the circuit introduction part 125 of the sensor 120 is guided by the slit 228 formed in the guide needle 220, the electrical connection between the sensor 120 and the electronic circuit 160 can be maintained before and after the sliding movement (FIG. 8 (C)).
- the sensor 120 is pulled out from the internal space 227 of the guide needle 220 and placed in the subcutaneous body of the living body. By placing the sensor 120 under the skin, it is possible to measure the analyte component in the living body over time.
- 1st peeling piece 361 which covers the 1st adhesion part 351 provided in the back side of body part 140 of sensor member 110 is peeled in conjunction with removing needle assembly 210 from sensor member 110.
- the cover material side peeling member 373 covering the cover material side adhesive portion 372 provided on the cover material 370 is peeled in conjunction with the removal of the needle assembly 210 from the sensor member 110. Since it is possible to perform the work of removing the first peeling piece 361 and the cover material side peeling member 373 in conjunction with the work of removing the needle assembly 210, the number of work steps required for installing the sensor 120 can be reduced. The sensor 120 can be installed in a simpler procedure.
- first peeling portion 361 and the cover material side peeling member 373 are peeled in advance before performing the work of fixing the sensor member 110 to the skin s.
- the entire sensor member 110 can be fixed to the skin s by a simple operation of bringing the cover 351 and the cover material side adhesive portion 372 into contact with the skin s.
- main body 140 of sensor member 110 is rotated using hinge 133 (rotation is indicated by arrow r 'in the figure).
- the sensor member 110 can be fixed by a simple operation of bringing the first adhesive portion 351 provided on the main body 140 of the sensor member 110 into contact with the skin s.
- the sensor member 110 may be bent by the rotation of the main body 140.
- the bending of the sensor member 110 may be prevented by setting the bent portion in a predetermined position in advance or using a soft material that allows bending.
- the sensor system 100 can be used without being affected.
- the cover material side adhesive portion 372 provided on the outer peripheral portion 371 of the cover material 370 is brought into contact with the skin s.
- the cover material 370 is fixed to the skin s through the cover material side adhesive portion 372.
- the sensor member 110 is fixed by the first and second adhesive portions 351 and 352 provided on the sensor member 110, and the sensor member 110 is fixed by the cover material-side adhesive portion 372 provided on the cover material 370.
- the sensor member 110 can be more firmly fixed to s.
- the portion of the cover material 370 bonded to the skin s functions as a seal portion, and the vicinity of the sensor 120 embedded in the subcutaneous body of the living body and the outside of the cover material 370 are separated in a liquid-tight manner. Become. Since it becomes possible to prevent the sensor member 110 and the sensor 120 from being immersed in water, it is possible to suitably prevent the malfunction of the sensor 120 due to the ingress of water. This makes it possible to continuously measure the analyte component with the sensor 120 installed on the living body.
- the signal processing circuit member 310 Since the signal processing circuit member 310 is attached to the sensor member 110 prior to the installation of the sensor system 100, it is not necessary to separately perform the work of attaching the signal processing circuit member 310 after the installation.
- the connection work of the signal processing circuit member 310 becomes complicated, and there is a possibility that a connection error between the sensor 120 and the signal processing circuit member 310 is induced.
- the sensor system 100 such a problem is not caused, and the sensor 120 can be installed on the living body more easily.
- the signal processing circuit member 310 detachably provided to the sensor member 110 can be shared by different sensor members 110.
- the sensor assembly 110 that is directly fixed to the skin s and the needle assembly 210 including the guide needle 220 that is punctured subcutaneously can be discarded every time it is used.
- the signal processing circuit member 310 including the electronic circuit 311 as a component is relatively expensive. However, since the signal processing circuit member 310 can be reused a plurality of times without being disposable, the cost of the user can be reduced. You can plan.
- the sensor 120 is attached to the living body in a state where the signal processing circuit member 310 including the electronic circuit 311 for processing the signal is attached to the sensor member 110 including the sensor 120. Since it is possible to perform a series of operations for installation, it is not necessary to perform the operation of attaching the signal processing circuit member 310 after the puncturing operation of the guide needle 220. For this reason, even when the sensor 120 is installed on a body surface portion that is difficult for the user to visually observe, the installation work of the signal processing circuit member 310 is not complicated, and the workability of the installation work of the sensor 120 is reduced. Can be improved. Thereby, the convenience of the user using the sensor system 100 can be improved.
- the sensor system 100 can be handled safely before the puncturing operation, while the movable part 150 is simply rotated.
- the puncture work can be prepared by the work.
- the guide needle 220 can be punctured by a simple operation of pressing the movable portion 150 toward the skin s while visually observing the needle portion 225 and the puncture position of the guide needle 220 exposed from the movable portion 150.
- the 1st adhesion part 351 provided in the back surface side of the main-body part 140 of the sensor member 110, and the 2nd adhesion part 352 provided in the back surface side of the movable part 150 of the sensor member 110 are only made to contact with skin s.
- the sensor member 110 can be fixed to the living body skin s by a simple operation.
- the second peeling piece 362 that covers the second adhesive portion 352 provided on the back surface side of the movable portion 150 of the sensor member 110 is peeled in advance prior to the puncturing operation, so that the movable portion 150 is skinned together with the puncturing operation. Can be fixed against. Furthermore, by disposing the second peeling piece 362 so as to cover the guide needle 220 held by the movable portion 150, it is possible to prevent the needle portion 225 of the guide needle 220 from protruding before the puncturing operation. And safety during use can be further improved.
- the first peeling piece 361 is peeled from the first adhesive portion 351 via the sensor side tongue 363, so that the number of work steps required for installing the sensor 120 is reduced.
- the sensor 120 can be installed by a simpler procedure.
- the main body 140 is rotated to remove the first assembly after the needle assembly 210 is removed.
- the sensor member 110 can be fixed by a simple operation of bringing the adhesive portion 351 into contact with the skin s.
- the sensor member 110 and the needle assembly 210 are provided so as to be connectable and separable along with the relative sliding movement along the longitudinal direction of the guide needle 220, the sensor member 110 and the needle assembly 210 are provided.
- the guide needle 220 and the sensor 120 can be prevented from being bent or caught at the time of connecting and disconnecting, and the sensor 120 can be accommodated in the guide needle 220 and the guide needle 220 can be smoothly removed from the living body. It can be carried out.
- the circuit introduction part 125 of the sensor 120 can be guided by the slit 228 formed in the guide needle 220, and the circuit introduction part 125 of the sensor 120 can be guided. And the guide needle 220 can be prevented from interfering with each other. Thereby, the connection by a slide movement and isolation
- the sensor member 110 can be more firmly fixed to the living body skin s.
- the portion of the cover material 370 bonded to the skin s functions as a seal portion, so that the sensor member 110 and the sensor 120 can be prevented from being immersed in water, and the sensor 120 is infused as water enters. It can prevent suitably that a malfunctioning generate
- the cover material side peeling member 373 is peeled from the cover material side adhesive portion 372 via the cover material side tongue 374, so that the work man-hour required for installing the sensor 120 is reduced. Therefore, the sensor 120 can be installed with a simpler procedure. Further, since the cover material side peeling member 373 is peeled in advance before the operation of fixing the sensor member 110 to the skin s, the cover material side peeling member 373 is removed from the skin s after the needle assembly 210 is removed. The sensor member 110 can be fixed by a simple operation of bringing the sensor member into contact with the sensor member 110.
- the cross-sectional shape of guide needle 220 is formed in a substantially C shape. Moreover, what converts the signal based on the analyte component of a biological body into an electrical signal is employ
- FIG. A conductive layer 392 that transmits an electrical signal to the electronic circuit 311 on the signal processing circuit member 310 side is sandwiched between two flexible substrates 391 in a liquid-tight manner.
- a holding layer 393 for adjusting the flexibility of the flexible substrate 391 is provided, and the sensor probe 123 of the sensor 120 is given a predetermined thickness to prevent the sensor probe 123 from falling out of the slit 228 of the guide needle 220. is doing.
- a flexible material such as polyimide, silicone rubber, nylon, fluorine resin, stainless steel, or the like similar to the flexible substrate 391 can be used.
- the holding layer 393 only needs to be installed in the vicinity of the sensor probe 123 at least at a predetermined position in the long axis direction of the sensor 120.
- the sensor 120 can have appropriate elasticity. By providing elasticity, it is possible to prevent the guide needle 220 from being caught by the sensor 120 when the needle assembly 210 is removed from the sensor member 110. Therefore, it is more preferable that the holding layer 393 is installed over the entire length of the sensor 120.
- the signal processing with the sensor 120 without using the electronic circuit 160 on the sensor member 110 side is performed. It is possible to employ a configuration in which signals are directly transmitted / received to / from the electronic circuit 311 on the circuit member 310 side. Since it is not necessary to install the electronic circuit 160, the sensor member can be downsized or simplified.
- the fixing member can be appropriately changed as long as the sensor member can be fixed on the surface of the skin.
- a configuration in which the first adhesive portion 351 and the second adhesive portion 352 are provided is desirable.
- a configuration in which a member for assisting fixation of a belt or the like provided with a hook-and-loop fastener is appropriately added may be used.
- the outer shape, the cross-sectional shape, and the material of the guide needle are not particularly limited to the forms shown in the embodiments, and can be appropriately changed as long as the insertion of the sensor into the living body skin can be guided. .
- the substantially U-shaped or substantially C-shaped cross-sectional shape shown in the embodiment it is possible to use, for example, an arc-shaped or polygonal cross-sectional shape.
- the method of guiding the sensor with the guide needle is not particularly limited to a mode in which the sensor is accommodated in the needle and guided, and for example, the sensor is assembled outside the guide needle and the sensor is attached along with the puncture of the guide needle. It is also possible to adopt a form in which the is inserted into the living body.
- 100 sensor system 110 sensor member, 111
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Abstract
Description
図20を参照して、改変例にあっては、ガイド針220の断面形状を略C字形に形成している。また、センサ120のセンサプローブ123には、生体のアナライト成分に基づく信号を電気信号に変換するものを採用している。電気信号を信号処理回路部材310側の電子回路311に伝える導電層392を、2枚のフレキシブル基板391によって液密に挟み込ませている。
110 センサ部材、
111 センサ部材の裏面、
120 センサ、
121 センサリード部、
123 センサプローブ、
125 回路導入部(接続部材)、
130 保持部、
131 凹ガイド、
133 ヒンジ(連結部材)、
140 本体部、
150 可動部、
210 針組立体、
220 ガイド針、
221 ガイド針の基端部、
223 ガイド針の先端部、
225 針部、
226 開口端、
227 内部空間、
228 スリット、
260 ロック部材、
310 信号処理回路部材、
311 電子回路、
350 固定部材、
351 第1接着部、
352 第2接着部、
360 センサ側剥離部材、
361 第1剥離片、
362 第2剥離片、
363 センサ側舌部、
370 カバー材、
371 外周部、
372 カバー材側接着部、
373 カバー材側剥離部材、
374 カバー材側舌部、
s 生体の皮膚。
Claims (10)
- 生体のアナライト成分を検知して信号を発信するセンサ、および前記センサを保持する保持部を備えるセンサ部材と、
前記センサ部材に着脱自在に取り付けられ、生体内への前記センサの挿入をガイドするガイド針を備える針組立体と、
前記センサ部材に着脱自在に取り付けられ、前記センサからの前記信号を処理する電子回路を備える信号処理回路部材と、
前記センサ部材を生体の皮膚に対して固定させる固定部材と、を有し、
前記センサ部材に前記信号処理回路部材を取り付けた状態で生体に対して前記センサが設置されることを特徴とするセンサシステム。 - 前記保持部は、前記ガイド針の基端部側を覆って保持する本体部と、
前記ガイド針の先端部側に形成された針部を覆って保持する可動部と、
前記本体部と前記可動部とを前記ガイド針の長軸方向と交わる軸方向を中心にして回動自在に連結する連結部材と、を有し、
前記可動部の回動によって前記針部の露出および遮蔽を切り替える、請求項1に記載のセンサシステム。 - 前記固定部材は、前記本体部の表面のうち前記生体に向かい合わせて配置される面に設けられた第1接着部と、
前記可動部の表面のうち前記生体に向かい合わせて配置される面に設けられた第2接着部と、
前記第1接着部および前記第2接着部を覆って剥離自在に取り付けられたセンサ側剥離部材と、を有する請求項2に記載のセンサシステム。 - 前記センサ側剥離部材は、前記第1接着部に取り付けられる第1剥離片と、前記第1剥離片から分離され前記第2接着部に取り付けられる第2剥離片と、を有し、
前記第2剥離片は、前記生体内への前記センサの挿入に先立って予め剥離される、請求項3に記載のセンサシステム。 - 前記第1剥離片は、当該第1剥離片を前記針組立体に連結するためのセンサ側舌部を有し、
前記センサ部材からの前記針組立体の取り外しに連動して前記センサ側舌部を介して前記第1剥離片が剥離される、請求項4に記載のセンサシステム。 - 前記センサ部材と前記針組立体とは、前記ガイド針の長軸方向に沿う相対的なスライド移動に伴って接続、分離可能に設けられており、
前記ガイド針は、先端部に形成された開口端と、前記センサを移動可能に収容する内部空間と、を有し、
前記センサ部材を前記針組立体に対して相対的にスライド移動させることにより、前記センサ部材と前記針組立体とが接続されるとともに、前記開口端を介して前記内部空間内に前記センサが収容され、
前記センサ部材と前記針組立体とが接続された状態から前記針組立体を前記センサ部材に対して相対的にスライド移動させることにより、前記センサ部材と前記針組立体とが分離されるととともに、前記内部空間から前記センサが引き出される、請求項1~5のいずれか1項に記載のセンサシステム。 - 前記センサは、接続部材を介して前記保持部に保持され、
前記ガイド針は、前記開口端から当該ガイド針の長軸方向に沿って伸びて形成され前記センサ部材および前記針組立体が相対的にスライド移動するときに前記接続部材をガイドするスリットを有する請求項6に記載のセンサシステム。 - 前記固定部材は、前記センサ部材からはみ出して配置される外周部を備えるとともに前記センサ部材の外表面を覆うカバー材と、
前記外周部における前記生体に向かい合わせて配置される面に設けられたカバー材側接着部と、
前記カバー材側接着部を覆って剥離自在に取り付けられたカバー材側剥離部材と、を有する請求項1~7のいずれか1項に記載のセンサシステム。 - 前記カバー材側剥離部材は、当該カバー材側剥離部材を前記針組立体に連結するためのカバー材側舌部を有し、
前記センサ部材からの前記針組立体の取り外しに連動して前記カバー材側舌部を介して前記カバー材側剥離部材が剥離される、請求項8に記載のセンサシステム。 - 請求項3に記載されたセンサシステムの使用方法であって、
前記可動部によって前記ガイド針の針部を覆わせた状態から前記可動部を回動させ、前記ガイド針の針部を露出させるステップと、
回動させた状態の前記可動部を前記第2接着部によって固定させるステップと、
前記センサの挿入を前記ガイド針によってガイドさせた後に、前記センサ部材から前記針組立体を取り外すステップと、
前記本体部を前記生体に向けて回動させるステップと、
前記本体部を前記第1接着部によって固定させるステップと、
を含むことを特徴とするセンサシステムの使用方法。
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JP7157055B2 (ja) * | 2017-07-05 | 2022-10-19 | テルモ株式会社 | センサ及びセンサの製造方法 |
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US20130281802A1 (en) | 2013-10-24 |
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