Sensing device

Abstract

According to one embodiment of the present invention, a sensing device includes: a substrate; a sensor unit, the sensor unit including an electrode arranged on the substrate and a connecting terminal arranged on the substrate and connected to the electrode; and a stretchable substrate, the stretchable substrate is connected to the sensor unit and includes a base and a wiring arranged on the base, wherein the connecting terminal of the sensor unit is connected to the wiring of the stretchable substrate.

Description

Technical Field

[0001] The present invention relates to a sensing device, and more particularly, to a sensing device including an in-vivo sensor to be inserted into a subject. Background Art

[0002] With the development of medical technology, research on medical bioinformatics measurement for real-time monitoring of body composition and physiological information is being actively carried out. During this period, interest in sensing devices for real-time and accurate measurement of body composition is increasing.

[0003] As an example, a sensing device including an in-vivo sensor may have a structure in which the sensor coated with a bioreactive material that reacts with body components in tissue fluid penetrates the skin and is inserted into the human body, and an electrical signal generated due to the electrochemical action between the body components and the bioreactive material is transmitted to a signal processing unit provided outside the body.

[0004] In this case, as the size of the in-vivo sensor inserted into the human body increases, the contact area with the body components increases, and thus the sensing accuracy increases. However, as the size of the in-vivo sensor increases, the irritation felt by the user may increase.

[0005] Furthermore, foreign matter, such as proteins flowing in interstitial fluid and body components to be detected, may be adsorbed onto in vivo sensors inserted into the human body. When foreign matter is adsorbed onto the sensor, sensing accuracy may be reduced, and the sensor's lifespan may be shortened.

[0006] At the same time, a transmitter that receives, processes, and transmits signals detected by the in-vivo sensor may be connected to the in-vivo sensor. Typically, the transmitter may include a hard printed circuit board (PCB) housed in a hard material housing, and when such a transmitter is attached to the skin, it may cause discomfort to the user. Summary of the Invention

[0007] Technical issues

[0008] The present invention aims to provide a sensing device that is accurate, has a long life, and minimizes user discomfort.

[0009] Technical Solution

[0010] According to an embodiment of the present invention, a sensing device includes: a sensor, which includes a substrate, an electrode arranged on the substrate, and a connecting terminal arranged on the substrate and connected to the electrode; and a stretchable substrate, which is connected to the sensor and includes a base and a wiring arranged on the base, wherein the connecting terminal of the sensor is connected to the wiring of the stretchable substrate.

[0011] The stretchable substrate may include a plurality of stacked wiring layers, and the connection terminal of the sensor may be provided between two wiring layers among the plurality of wiring layers.

[0012] The substrate may be provided between adjacent wiring layers among the plurality of wiring layers.

[0013] Each of the plurality of wiring layers may include a metal layer and a support layer.

[0014] At least a portion of the sensor may be inserted into the stretchable substrate, and a remaining portion of the sensor may be drawn out from the stretchable substrate.

[0015] The electrodes of the sensor drawn out from the stretchable substrate may be housed in a biodegradable sensor guide and may be injected into the body together with the biodegradable sensor guide.

[0016] A portion of the sensor guide may be inserted into the stretchable substrate, and a remaining portion of the sensor guide may be exposed outside the stretchable substrate.

[0017] The remaining portion of the sensor guide may have a length greater than a length of the portion of the sensor guide.

[0018] The substrate may be divided into an electrode region where the electrodes are provided and a connection terminal region where the connection terminals are provided, and a width of the connection terminal region may be greater than a width of the electrode region.

[0019] The width of the connection terminal region may be greater than 1 times and not greater than 5 times the width of the electrode region.

[0020] The wiring of the stretchable substrate may include a plurality of pads and a connector configured to connect the plurality of pads, and a width of the connection terminal may be different from a width of the pads.

[0021] The sensing device may further include an adhesive portion disposed between the connection terminal and the pad.

[0022] The adhesive portion may have a width between a width of the connection terminal and a width of the pad.

[0023] The multiple wiring layers may include a first wiring layer and a second wiring layer, the first wiring layer facing a first surface of the two surfaces of the substrate on which the connecting terminals of the sensor are provided, and the second wiring layer facing a second surface opposite to the first surface. The sensing device may also include at least one of a signal processing unit and a transmission unit connected to the first wiring layer and buried in the stretchable substrate.

[0024] The at least one of the signal processing unit and the transmission unit may include a hard printed circuit board (PCB) and a chip provided on the hard PCB.

[0025] A signal processing circuit pattern configured to process a signal received from the electrode through the connection terminal may be further provided on a first surface, on which the connection terminal of the sensor is provided, of both surfaces of the substrate.

[0026] The substrate may include a first surface and a second surface opposite to the first surface, at least one of a reference electrode, a working electrode, and a counter electrode may be arranged on the first surface and the second surface, and a plurality of connection terminals identical to the connection terminals may be arranged on at least one of the first surface and the second surface.

[0027] The substrate may include a first surface and a second surface opposite to the first surface, and may be wound in a spiral shape so that the first surface faces outward and the second surface faces inward, and at least one of a reference electrode, a working electrode, and an auxiliary electrode may be disposed on the first surface and the second surface.

[0028] The substrate may include a first surface and a second surface opposite to the first surface, and may be wound in a spiral shape so that the first surface faces outward and the second surface faces inward, at least one reference electrode may be disposed on the first surface, and at least one working electrode and at least one auxiliary electrode may be disposed on the second surface.

[0029] Beneficial effects

[0030] According to embodiments of the present invention, an in-vivo sensor with excellent sensing performance and a long lifespan can be obtained by minimizing the influence of foreign matter. According to embodiments of the present invention, a sensing device including an in-vivo sensor can be obtained, which can minimize discomfort such as irritation felt by a user. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A conventional continuous glucose monitoring system (CGMS) is shown;

[0032] Figure 2 yes Figure 1 A cross-sectional view of an example of a sensor in a CGMS;

[0033] Figure 3 is a block diagram of a sensing device according to an embodiment of the present invention;

[0034] FIG4( a ) is a cross-sectional view of a sensor according to an embodiment of the present invention, and FIG4( b ) is a top view of a sensor according to an embodiment of the present invention;

[0035] FIG5( a ) is a top view of a sensor according to another embodiment of the present invention, FIG5( b ) is a cross-sectional view taken along line AA′ of FIG5( a ), and FIG5( c ) is a cross-sectional view taken along line BB′ of FIG5( a );

[0036] FIG6( a ) is a top view of a sensor according to yet another embodiment of the present invention, FIG6( b ) is a cross-sectional view taken along line AA′ of FIG6( a ), and FIG6( c ) is a cross-sectional view taken along line BB′ of FIG6( a );

[0037] FIG7( a ) is a top view of a sensor according to another embodiment of the present invention, and FIG7( b ) is a bottom view of a sensor according to another embodiment of the present invention;

[0038] Figure 8 is a view showing a form in which a sensor is wound into a spiral shape according to one embodiment of the present invention;

[0039] Figure 9 is a view showing a form in which a sensor is wound into a spiral shape according to another embodiment of the present invention;

[0040] Figure 10 This is a diagram for explaining the principle of a sensor wound into a spiral shape;

[0041] Figure 11 A diagram for describing a process of manufacturing a sensor and a process of injecting the sensor into a body according to an embodiment of the present invention is shown;

[0042] Figure 12 is a top view of a stretchable substrate according to an embodiment of the present invention;

[0043] Figure 13 is a cross-sectional view of a sensing device according to one embodiment of the present invention;

[0044] Figure 14 is a cross-sectional view of a sensing device according to another embodiment of the present invention;

[0045] Figure 15 is an image of a sensing device according to one embodiment of the present invention. DETAILED DESCRIPTION

[0046] Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

[0047] However, the technical spirit of the present invention is not limited to the several embodiments disclosed below, but can be implemented in various forms. Without departing from the technical spirit of the present invention, one or more components can be selectively combined and replaced for use between embodiments.

[0048] In addition, unless otherwise defined, the terms (including technical and scientific terms) used herein can be interpreted as having the same meaning as commonly understood by those skilled in the art to which the present invention belongs. General terms such as those defined in dictionaries can be interpreted in light of the contextual meaning of the relevant technology.

[0049] Furthermore, the terminology used herein is intended to describe the embodiments and is not intended to limit the present invention.

[0050] In this specification, terms expressed in the singular may include plural forms unless otherwise specified. When it is expressed as "at least one (or one or more) of A, B and C", it may include one or more of all possible combinations of A, B and C.

[0051] Furthermore, terms such as “first,” “second,” “A,” “B,” “(a),” and “(b)” may be used herein to describe components of embodiments of the present invention.

[0052] These terms are not used to define the nature, order, or sequence of the corresponding components but are only used to distinguish the corresponding components from other components.

[0053] When a component is described as being “connected,” “coupled,” or “engaged” to another component, such description may include a case where one component is directly “connected,” “coupled,” or “engaged” to another component, as well as a case where one component is “connected,” “coupled,” or “engaged” to another component via another component disposed between the one component and the other component.

[0054] In addition, when any component is described as being formed or disposed “on (or under)” another component, such description includes a case where the two components are formed in direct contact with each other, and also includes a case where the two components are indirectly in contact with each other via one or more other components interposed therebetween. In addition, when a component is described as being formed “on (or under)” another component, such description includes a case where the one component is formed on the upper side or the lower side relative to the other component.

[0055] Figure 1 A conventional continuous glucose monitoring system (CGMS) is shown. Figure 2 yes Figure 1 A cross-sectional view of an example of a sensor within a CGMS.

[0056] refer to Figure 1 and Figure 2 , a general CGMS 10 includes an in-vivo sensor 12 and a transmitter 14. The in-vivo sensor 12 may be in the form of a needle that pierces the skin and is inserted into the body. The in-vivo sensor 12 may include an electrode 20, an enzyme layer 22 disposed on the electrode 20, and a semipermeable membrane 24 disposed on the enzyme layer 22. The CGMS 10 may be a system for measuring blood sugar, and the enzyme layer 22 may include glucose oxidase. When the in-vivo sensor 12 penetrates the skin and is inserted into the body, the glucose in the tissue fluid reacts with the glucose oxidase in the enzyme layer 22 and is converted into gluconic acid to release a certain charge. The certain charge reacts with the electrode 20 to generate an electric current, and the current flowing in the electrode 20 is transmitted along a wiring (not shown) to the transmitter 14 outside the body. The transmitter 14 sends data related to the current sent from the electrode 20 to the external terminal 30, so that the external terminal 30 can output the blood sugar information in the body.

[0057] Here, for convenience of description, an example of a general CGMS has been described, but the embodiments of the present invention are not limited thereto. The embodiments of the present invention are applicable to various in-vivo sensors that can penetrate into the body and detect body components in tissue fluid.

[0058] Figure 3 is a block diagram of a sensing device according to an embodiment of the present invention.

[0059] refer to Figure 3 , the sensing device 100 includes a sensor 110 , a signal processing unit 120 and a transmission unit 130 , and the transmission unit 130 communicates with the external terminal 200 .

[0060] Sensor 110 penetrates the skin and is inserted into the body to detect body components in interstitial fluid. To this end, sensor 110 may utilize an electrochemical reaction between a specific body component and a bioreactive material that reacts therewith. When ions and / or electrons are generated by the electrochemical reaction between the specific body component and the bioreactive material, the resulting current can be used to detect the presence or concentration of the specific body component. Because at least a portion of sensor 110 is implanted within the body, sensor 110 may be referred to as an in-vivo sensor in this specification. The specific structure of sensor 110 will be described below.

[0061] Here, the specific body component is not limited to blood glucose, and may be any of various biochemical materials or various biomarkers, such as blood glucose, lactate, cholesterol, dopamine, coral, Na, etc. present in blood or tissue fluid. + 、Ka +The bioreactive material may be a material that reacts with a specific body component and may be an enzyme, etc. For example, when the sensor 110 is to detect the glucose level in the body, the bioreactive material may be glucose oxidase.

[0062] Sensor 110 includes connecting wires and connecting terminals, and the electrodes of sensor 110 are connected to signal processing unit 120 via the connecting wires and connecting terminals. Here, the connecting wires can be connected to the electrodes of sensor 110, and the current flowing in the electrodes of sensor 110 disposed inside the body can be transmitted to signal processing unit 120 outside the body via the connecting wires and connecting terminals. Signal processing unit 120 uses the amount of current received from sensor 110 to calculate information about a specific body component. To this end, signal processing unit 120 can perform analog-to-digital conversion on the amount of current received from sensor 110, and then can calculate the concentration of the specific body component.

[0063] The signal processing unit 120 transmits the calculated information to the external terminal 200 through the transmission unit 130. In this case, the transmission unit 130 may communicate with the external terminal 200 wirelessly or by wire, and the external terminal 200 may output the information received from the transmission unit 130 to a display or the like.

[0064] Figure 4(a) is a cross-sectional view of a sensor according to one embodiment of the present invention, and Figure 4(b) is a top view of a sensor according to one embodiment of the present invention. Figure 5(a) is a top view of a sensor according to another embodiment of the present invention, Figure 5(b) is a cross-sectional view taken along line AA' of Figure 5(a), and Figure 5(c) is a cross-sectional view taken along line BB' of Figure 5(a). Figure 6(a) is a top view of a sensor according to yet another embodiment of the present invention, Figure 6(b) is a cross-sectional view taken along line AA' of Figure 6(a), and Figure 6(c) is a cross-sectional view taken along line BB' of Figure 6(a). Figure 7(a) is a top view of a sensor according to yet another embodiment of the present invention, and Figure 7(b) is a bottom view of a sensor according to yet another embodiment of the present invention.

[0065] 4 to 7 , the sensor 110 includes a substrate 300 , and a reference electrode 310 , a working electrode 320 , and an auxiliary electrode 330 disposed on the substrate 300 .

[0066] Here, the substrate 300 may be flexible and may include a first surface 302 and a second surface 304 opposite to the first surface 302. Here, the substrate 300 of the sensor 110 may be a flexible substrate. The flexible substrate may be a flexible substrate that is not easily broken, bendable, rollable, and foldable. To this end, the substrate 300 may be made of, for example, liquid crystal polymer (LCP), polyetheretherketone (PEEK), polyimide (PI), etc. Therefore, since the substrate 300 is biocompatible and can be flexibly bent according to the flow of tissue fluid in the body, the substrate 300 can minimize the user's irritation and can be thermoformed. In addition, the thickness of the substrate 300 may be 10 μm to 150 μm, preferably 30 μm to 130 μm, and more preferably 50 μm to 100 μm. Therefore, the shape of the thermoformed substrate 300 can be stably maintained.

[0067] The working electrode 320 may be an electrode that undergoes an electrochemical reaction and may be coated with a bioreactive material that reacts with a specific body component. Here, the specific body component may be a component to be detected by the sensor 110 and may be any of various biochemical materials or various biomarkers, such as blood glucose, lactate, cholesterol, dopamine, coral, Na, etc., present in blood or tissue fluid. + 、Ka + and urea. The bioreactive material may be a material that reacts with a specific body component, such as an enzyme. Although not shown, a semipermeable membrane may be further provided over the bioreactive material. Thus, only the specific body component to be detected can pass through the semipermeable membrane, thereby preventing the bioreactive material applied to working electrode 320 from separating from working electrode 320.

[0068] The reference electrode 310 is an electrode that forms a potential difference with the working electrode 320, and the auxiliary electrode 330 is an electrode used to measure the current signal of the working electrode 320. That is, a constant voltage can be maintained in the auxiliary electrode 330, and a current can flow in the working electrode 320 due to the reaction between the bioreactive material and a specific body component. The reference electrode 310 can be used to apply a constant voltage to the auxiliary electrode 330. The working electrode 320 can be referred to as an operating electrode, and the auxiliary electrode 330 can be referred to as a relative electrode.

[0069] 4(a) and 4(b), at least one reference electrode 310, at least one working electrode 320, and at least one auxiliary electrode 330 may be provided on the first surface 302 of the substrate 300, and the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may be connected to the connection terminals 351, 352, and 353 through wirings W1, W2, and W3, respectively. Here, the wirings W1, W2, and W3 and the connection terminals 351, 352, and 353 may transmit the current flowing in the electrodes 310, 320, and 330 of the sensor 110 to the signal processing unit 120 outside the body.

[0070] Alternatively, as shown in Figures 5(a) to 5(c), at least one of the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may be provided on each of the first surface 302 and the second surface 304 of the substrate 300. For example, the working electrode 320 and the auxiliary electrode 330 may be provided on the first surface 302 of the substrate 300, and the reference electrode 310 may be provided on the second surface 304. In this case, the connection terminal 351 connected to the reference electrode 310 may be provided on the first surface 302 of the substrate 300, and the wiring W1 connecting the reference electrode 310 and the connection terminal 351 may be provided on the second surface 304 together with the reference electrode 310 to connect to the connection terminal 351 through the through-hole 306. Therefore, since the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 are provided on both surfaces of the substrate 300, the number of electrodes provided per unit volume or unit area occupied by the sensor 110 increases, thereby improving measurement accuracy.

[0071] Alternatively, as shown in Figures 6(a) to 6(c), the reference electrode 310, the working electrode 320, the auxiliary electrode 330, and the connection terminal 350 can all be provided on one surface of the substrate 300, and some or all of the wirings W1, W2, and W3 used to connect the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 to the connection terminal 350 can be provided on another surface thereof. For example, the reference electrode 310, the working electrode 320, the auxiliary electrode 330, the connection terminal 350, and the wirings W2 and W3 can be provided on the first surface 302 of the substrate 300, while the wiring W1 used to connect the reference electrode 310 and the connection terminal 351 can be provided on the second surface 304 of the substrate 300. Therefore, since the electrodes 310, 320, and 330 and the wirings W1, W2, and W3 are distributed and provided on both surfaces of the substrate 300, the number of electrodes provided per unit volume or unit area occupied by the sensor 110 increases, thereby improving measurement accuracy.

[0072] To this end, at least one through-hole 306 may be formed in the substrate 300, through which at least one of the wiring W1 connected to the reference electrode 310, the wiring W2 connected to the working electrode 320, and the wiring W3 connected to the auxiliary electrode 330 may pass, and the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may be connected to the connection terminals 351, 352, and 353 through the wirings W1, W2, and W3, respectively. Here, the current flowing in the wirings W1, W2, and W3 and the connection terminals 351, 352, and 353 may be transmitted to the signal processing unit 120 outside the body. Therefore, since the connection terminals 350 are gathered on one side of both surfaces of the substrate 300 and then led out of the body, wiring is easy.

[0073] 7(a) and 7(b), a plurality of reference electrodes 310, a plurality of working electrodes 320, and a plurality of auxiliary electrodes 330 may be provided on each of the first surface 302 and the second surface 304 of the substrate 300. Therefore, since the plurality of reference electrodes 310, the plurality of working electrodes 320, and the plurality of auxiliary electrodes 330 are provided on both surfaces of the substrate 300, the number of electrodes provided per unit volume or unit area occupied by the sensor 110 increases, thereby improving measurement accuracy.

[0074] When the connection terminal 350 is set on the first surface 302 of the substrate 300, the wirings W1, W2 and W3 connected to the electrodes 310, 320 and 330 set on the second surface 304 of the substrate 300 can be connected to the connection terminal 350 set on the first surface 302 of the substrate 300 through the through hole 306.

[0075] Although not shown, a set of reference electrodes 310, working electrodes 320, and auxiliary electrodes 330 can be connected to a set of connection terminals 351, 352, and 353 via a set of wirings W1, W2, and W3. That is, when one sensor 110 includes multiple sets of reference electrodes 310, working electrodes 320, and auxiliary electrodes 330, a separate set of connection terminals 351, 352, and 353 can be provided for each set of reference electrodes 310, working electrodes 320, and auxiliary electrodes 330. Therefore, sensing accuracy can be improved.

[0076] 4( a), a seed layer 340 may be further provided between the substrate 300 and the reference electrode 310, the working electrode 320, and the auxiliary electrode 330, and the seed layer 340 may include at least one selected from titanium (Ti) and nickel (Ti). Thus, the bonding strength between the substrate 300 and the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may be improved.

[0077] Alternatively, the substrate 300 may be pre-treated before forming the seed layer 340 on the substrate 300. For example, when the surface of the substrate 300 is plasma-treated or coated with a hydrophilic primer, the seed layer 340 is advantageously formed on the surface of the substrate 300 because the surface of the substrate 300 becomes hydrophilic.

[0078] Therefore, adhesion between the substrate 300 , the seed layer 340 , and the electrodes 310 , 320 , and 330 may be improved.

[0079] At the same time, each of the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may include nanoparticles selected from at least one of gold (Au) and platinum (Pt), and the reference electrode 310 may further include silver chloride (AgCl), and each of the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may be provided on the substrate 300 by deposition, sputtering, electroplating, evaporation, coating, etc. The particle size of the nanoparticles constituting the electrodes 310, 320, and 330 may be changed according to the processing conditions of deposition, sputtering, electroplating, evaporation, coating, etc. According to an embodiment of the present invention, each of the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may include at least one selected from gold (Au) and platinum (Pt). In this case, each of the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 may be made of corrugated metal or porous metal. Therefore, the sensing accuracy can be improved. In this case, each of the reference electrode 310, the working electrode 320 and the auxiliary electrode 330 can be made of nanoparticles having a D50 of 5nm to 100nm, preferably a D50 of 5nm to 75nm, and more preferably a D50 of 5nm to 50nm. Therefore, since the surfaces of the electrodes 310, 320 and 330 are smooth, the possibility of adsorption of foreign matter can be reduced. Here, foreign matter can be substances such as proteins, platelets, cells, fibroblasts, immune substances or blood cells present in the blood or tissue fluid in addition to the body components to be detected. When foreign matter is adsorbed onto the surfaces of the electrodes 310, 320 and 330, the sensing function may be reduced and the life of the sensor may be shortened.

[0080] Alternatively, to reduce the possibility of foreign matter adsorbing onto the electrodes 310, 320, and 330, the surfaces of the electrodes 310, 320, and 330 may be coated with a hydrophobic material. When the surfaces of the electrodes 310, 320, and 330 are coated with the hydrophobic material, foreign matter is not adsorbed onto the surfaces of the electrodes 310, 320, and 330. Here, the hydrophobic material may be a biocompatible hydrophobic material, and its type is not particularly limited.

[0081] Meanwhile, according to an embodiment of the present invention, the sensor may be implemented in a spirally wound form.

[0082] Figure 8 FIG. 1 is a view showing a sensor wound into a spiral shape according to an embodiment of the present invention. Figure 9 FIG. 1 is a view showing a form in which a sensor is wound into a spiral shape according to another embodiment of the present invention.

[0083] refer to Figures 8 and 9 , the substrate 300 can be wound into a spiral shape so that the first surface 302 of the substrate 300 faces outward and the second surface 304 thereof faces inward. Here, the spiral shape can be a three-dimensional shape that repeatedly rotates with a certain curvature and extends in a certain direction (e.g., the Z direction), and can be a shape in which the substrate is continuous around the outer circumference of a cylinder. The spiral shape can be used interchangeably with the helical line shape, etc. When the substrate 300 is wound in a spiral shape as described above, since the stress applied to the substrate 300 can be dispersed, the substrate 300 can be more flexible than a flat substrate, thereby reducing the impact on the flow of tissue fluid and reducing the feeling of irritation.

[0084] In this case, the substrate 300 can be wound into a spiral shape with a width D ranging from 10 μm to 1000 μm, preferably from 100 μm to 800 μm, and more preferably from 300 μm to 600 μm. The width D can refer to the length in the X direction, perpendicular to the Z direction, of the spiral shape extending along the Z direction, and can refer to the maximum distance between the first surface 302 and the other first surface 302 at a specific position on the Z axis. When the width D of the substrate 300 meets this numerical range, certain body components can freely pass through the empty space formed by the second surface 304. Capillary action can act on the empty space formed by the second surface 304, and tissue fluid can be easily collected and drained.

[0085] In addition, the gap H between the spirals constituting the spiral shape of the substrate 300 may be in the range of 1 μm to 300 μm, preferably in the range of 5 μm to 200 μm, and more preferably in the range of 10 μm to 100 μm. When the gap H between the spirals satisfies such a numerical range, the possibility of foreign matter such as protein entering the spiral shape (i.e., the empty space formed by the second surface 304) can be reduced.

[0086] Meanwhile, according to one embodiment of the present invention, Figure 8As shown, the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 can be disposed on the first surface 302 of the substrate 300, and the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 can also be disposed on the second surface 304 of the substrate 300. When the reference electrode 310, the working electrode 320, and the auxiliary electrode 330 are disposed on both surfaces of the substrate 300, the contact area with the specific component to be measured is increased, thereby improving the sensing accuracy.

[0087] Alternatively, according to another embodiment of the present invention, Figure 9 As shown, the reference electrode 310 may be disposed on the first surface 302 of the substrate 300, and the working electrode 320 and the auxiliary electrode 330 may be disposed on the second surface 304. Here, the substrate 300 may be wound in a spiral shape such that the first surface 302 on which the reference electrode 310 is disposed faces outward, and the second surface 304 on which the working electrode 320 and the auxiliary electrode 330 are disposed faces inward. Figure 10 As shown, when the substrate 300 is wound in a spiral shape (the spiral shape has a width D in the range of 10μm to 1000μm, preferably in the range of 100μm to 800μm, more preferably in the range of 300μm to 600μm, and has a gap H in the range of 1μm to 300μm, preferably in the range of 5μm to 200μm, more preferably in the range of 10μm to 100μm), the specific body component to be detected can freely pass through the interior of the spiral, that is, the empty space formed by the second surface 304, and the possibility of foreign matter entering can be reduced. According to an embodiment of the present invention, when the first surface 302 on which the reference electrode 310 having less influence on the degradation of the sensing function is provided is set to face outward and the second surface 304 on which the working electrode 320 and the auxiliary electrode 330 on which the electrochemical reaction substantially occurs are provided is set to face inward, the accuracy and durability of the sensor can be improved.

[0088] Figure 11 A diagram for describing a process of manufacturing a sensor and a process of injecting the sensor into a body according to an embodiment of the present invention is shown. Since the sensor is injected into the body, the sensor may be referred to as an in-vivo sensor in this specification.

[0089] In order to manufacture a sensor according to an embodiment of the present invention, electrodes 310, 320 and 330 are formed on a substrate 300. Here, the substrate 300 can be made of LCP, PEEK, PI, etc. As described above, after the surface of the substrate is pretreated by plasma treatment or coating with a hydrophilic primer, a seed layer can be formed to form the electrodes. As described above, the electrodes 310, 320 and 330 can be formed by a method of depositing, sputtering, electroplating, evaporating or applying nanoparticles of at least one selected from gold (Au) and platinum (Pt). The surface pretreatment of the substrate 300, the formation of the seed layer and the formation of the electrodes can all be performed on both surfaces of the substrate.

[0090] Next, the substrate on which the electrodes 310, 320, and 330 are formed is thermoformed. Thus, the substrate on which the electrodes are formed may be wound in a spiral shape.

[0091] Next, the electrodes are coated with enzymes. To this end, dip casting can be performed on a spirally wound substrate on which the electrodes are formed. The enzyme solution can be sprayed onto the electrodes in an enzyme solution, or the substrate on which the electrodes are formed can be unfolded and fixed and then drop-casted into the enzyme solution. As described above, after the substrate on which the electrodes are formed is thermoformed, when the electrodes are coated with enzymes, the problem of enzyme denaturation due to heat can be prevented.

[0092] Next, the enzyme-coated sensor is inserted into the sensor guide.

[0093] refer to Figure 11 (a) The sensor guide 400 is needle-shaped with a pointed tip and may have an empty space formed in its interior 410. Although not shown, the end of the sensor guide 400 may be open. The sensor formed according to the above method is inserted into the sensor guide 400. In this case, the sensor may be thermoformed and wound in a spiral shape, or may be inserted into the sensor guide 400 in an unrolled flat shape.

[0094] like Figure 11 As shown in (b), the sensor deployed in a planar shape is surrounded by the sensor guide 400 and is injected into the body together with the sensor guide 400.

[0095] Thereafter, when the sensor guide 400 is independently withdrawn from the body, the sensor may be separated from the sensor guide 400 and may be rolled in the thermoformed shape again.

[0096] Alternatively, the sensor guide 400 may be made of a biodegradable material. Here, the biodegradable material may be a biodegradable polymer, and the biodegradable polymer may be, for example, a polylactide (PLA) or polyglycolic acid (PGA) based polymer.

[0097] Therefore, after the sensor is injected into the body together with the sensor guide 400 , the sensor can be rolled again in the thermoformed shape when the sensor guide 400 biodegrades in the body.

[0098] As described above, since the substrate 300 according to an embodiment of the present invention is made of LCP, PEEK or PI, the substrate 300 can be formed into a spiral shape by heating, and after the substrate 300 is inserted into the sensor guide 400 in a state in which it is unfolded by physical force and injected into the body, when the substrate 300 is separated from the sensor guide 400 or the sensor guide 400 is decomposed, the substrate 300 can be restored to the spiral shape again.

[0099] Therefore, the helically twisted sensor can be easily injected into the body without causing discomfort to the user or damaging the sensor.

[0100] At the same time, as described above, the current of the in-vivo sensor, that is, the current of the sensor 110, can be transmitted to the signal processing unit 130 outside the body through the connection unit 120, and the signal processing unit 130 can use the amount of current received from the sensor 110 through the connection unit 120 to calculate information about a specific body composition, and can send the calculated information to the external terminal 200 through the transmission unit 140. Figure 1 The transmitter 14 may include a connection unit 120, a signal processing unit 130, and a portion of a transmission unit 140, and may be attached to the outside of the body, typically to the user's skin.

[0101] In one embodiment of the present invention, Figure 1 The transmitter 14 can be implemented using a stretchable substrate. When the transmitter 14 is implemented using a stretchable substrate, the transmitter 14 is stretchable and directly attached to the skin, thereby minimizing irritation or discomfort felt by the user.

[0102] Figure 12 is a top view of a stretchable substrate according to an embodiment of the present invention.

[0103] refer to Figure 12 , the stretchable substrate 600 includes a base 610 and a wiring 620 disposed on the base 610.

[0104] The wiring 620 includes a first pad 622 , a second pad 624 , and a connector 626 for connecting the first pad 622 and the second pad 624 .

[0105] Here, the substrate 610 may have flexible properties that are not easily damaged, bendable, curlable, and foldable, and may also have stretchable or shrinkable properties. Therefore, the substrate 610 may be implemented as having a curved surface, which can be stretched in at least one direction by an external force, and can be restored to its original state when the external force is removed. Therefore, the substrate 610 may be a stretchable substrate. To this end, the substrate 610 may include a polymer resin having a certain elasticity. For example, the substrate 610 may include at least one selected from polyurethane (PU) and polydimethylsiloxane (PDMS). Therefore, the substrate 610 can be elastically stretched or shrunk according to the external force.

[0106] At the same time, the first pad 622 and the second pad 624 can be provided on the substrate 610. The first pad 622 and the second pad 624 can be made of the same material as the connector 626, or can be made of a material different from the material of the connector 626 and having conductivity. A semiconductor element is provided on the first pad 622 and the second pad 624, and the first pad 622 and the second pad 624 can be connected to the semiconductor element. Alternatively, the first pad 622 and the second pad 624 can be electrically connected to a component of the substrate 610 or can be connected to an external power supply. In this case, the first pad 622 and the second pad 624 can bend or stretch as the substrate 610 bends or stretches / contracts.

[0107] The first pad 622, the second pad 624, and the connector 626 may include a support layer and a metal layer disposed on the support layer. The metal layer may include at least one selected from gold (Au), copper (Cu), platinum (Pt), and silver (Ag), and the support layer may include at least one selected from LCP, PEEK, and PI. In this case, the support layer may be disposed in contact with the substrate 610. Therefore, the adhesion between the metal layer and the substrate 610 can be increased.

[0108] Meanwhile, the connector 626 may include a repeated bending pattern. For example, the repeated bending pattern may be a zigzag zigzag pattern, etc. Therefore, the wiring 620 may be a stretchable wiring, and as Figure 12 As shown in (b), the connector 626 can also stretch or shrink as the stretchable substrate 610 stretches or shrinks.

[0109] Alternatively, the connector 626 may be wound into a spiral shape between the first pad 622 and the second pad 624. The spiral shape may be a three-dimensional shape that repeatedly rotates with a certain curvature and extends in a certain direction, wherein the certain direction may be, for example, a direction parallel to the plane direction of the substrate 610, that is, a direction from the first pad 622 toward the second pad 624 or a direction from the second pad 624 toward the first pad 622. The spiral shape may be used interchangeably with a spiral line shape, etc. In this case, the diameter of the spiral shape may be in the range of 30 μm to 1 mm, preferably in the range of 50 μm to 500 μm, more preferably in the range of 100 μm to 300 μm, and the gap between the spirals of the spiral shape may be in the range of 1 μm to 5 mm, preferably in the range of 100 μm to 3 mm, more preferably in the range of 300 μm to 2 mm.

[0110] Therefore, the wiring 620 can also bend or stretch / contract without restriction as the substrate 610 bends or stretches / contracts, and the integration of the wiring 620 can be increased, so that the overall size of the stretchable substrate 600 can be miniaturized. In particular, even when the wiring 620 is made of an inorganic material that has no elasticity, since the wiring 620 can bend or stretch / contract along with the substrate 610 due to its spiral shape, the wiring 620 can be free from material restrictions. In addition, even when the wiring 620 is also bent or stretched / contracted as the substrate 610 bends or stretches / contracts, since the actual length of the wiring 620 does not increase, the change in resistance can be minimized, and a reliably stretchable substrate can be obtained.

[0111] According to an embodiment of the present invention, the sensor can be connected to a stretchable substrate, and the stretchable substrate can include the functions of a signal processing unit and a transmission unit. According to an embodiment of the present invention, the stretchable substrate included in the sensing device can be stretched by up to 30% to 50% by an external force.

[0112] Figure 13 is a cross-sectional view of a sensing device according to an embodiment of the present invention, Figure 14 is a cross-sectional view of a sensing device according to another embodiment of the present invention.

[0113] refer to Figures 13 and 14 , the sensing device 1000 includes a sensor and a stretchable substrate connected to the sensor. Here, the sensor can be Figure 11 Describe the sensor.

[0114] As described above, each stretchable substrate includes a base and wiring disposed on the base.

[0115] As an example, each stretchable substrate 600-1, 600-2, 600-3 and 600-4 can be manufactured by the following method, in which after the metal layer 620-2 and the support layer 620-1 are sequentially coated on a polyethylene terephthalate (PET) film, the metal layer 620-2 and the support layer 620-1 are patterned to form wiring, and then the wiring is buried in the base 610, and the PET film is peeled off.

[0116] The stretchable substrates 600-1, 600-2, 600-3 and 600-4 manufactured by this method can be stacked into multiple layers and thus can be stacked into multiple wiring layers. The wirings arranged on different layers can be electrically connected to each other through through-holes 630 formed in the wiring. For example, in the two-layer wiring included in different stretchable substrates 600-1, 600-2, 600-3 and 600-4, through-holes 630 can be formed, which can then be filled with a conductive material to form a via. The conductive material filling the through-hole can be any one of copper (Cu), silver (Ag), tin (Sn), gold (Au), nickel (Ni) and palladium (Pd), and the through-hole can be filled by any one of chemical plating, electrolytic plating, screen printing, sputtering, evaporation, inkjet and dispensing or a combination thereof. A passage can be formed by using palladium / nickel / chromium to form a seed layer by chemical plating and then filling the through-hole 630 with a metal material by electrolytic plating, screen printing, etc. Furthermore, after stacking a plurality of wiring layers (eg, a first layer, a second layer, a third layer, and a fourth layer), vias connecting the plurality of layers may be formed.

[0117] Although the following example is described here: the sensing device includes a total of four stretchable substrates 600-1, 600-2, 600-3 and 600-4 and includes a total of four wiring layers by forming a wiring layer on each stretchable substrate, the present invention is not limited to this. The sensing device may include a total of two or more stretchable substrates, preferably a total of three or more stretchable substrates, and therefore may include a total of two or more wiring layers, preferably a total of three or more wiring layers. According to an embodiment of the present invention, the total thickness of the four stretchable substrates 600-1, 600-2, 600-3 and 600-4 may be less than 2 mm. Therefore, the irritation and discomfort felt by the user can be minimized.

[0118] refer to Figure 13 and Figure 14As an example, the connection terminal 350 of the sensor may be provided between the wiring layer of the third stretchable substrate 600-3 and the wiring layer of the fourth stretchable substrate 600-4. At least a portion of the sensor may be inserted into the stretchable substrates 600-1, 600-2, 600-3, and 600-4, and the remaining portion thereof may be led out from the stretchable substrates 600-1, 600-2, 600-3, and 600-4. For example, the electrodes 310, 320, and 330 of the sensor may pass through some of the stretchable substrates 600-1, 600-2, and 600-3 among the plurality of stretchable substrates and may be led out from the stretchable substrates.

[0119] In this case, one of the two surfaces of the sensor substrate 300 may be arranged to face the fourth stretchable substrate 600-4, and the other surface thereof may be arranged to face the third stretchable substrate 600-3. The space between the third and fourth stretchable substrates 600-3 and 600-4 where the sensor is arranged may be filled with silicon (Si) or silicone resin.

[0120] The sensor's connection terminal 350 may be disposed between the third and fourth stretchable substrates 600-3 and 600-4, the sensor's wiring substrate 300 may pass through a total of three stretchable substrates 600-1, 600-2, and 600-3 and may be drawn out of the stretchable substrates 600-1, 600-2, and 600-3, and the sensor's electrodes 310, 320, and 330 may be inserted into the body while being housed in the sensor guide 400. In this case, a portion of the sensor guide 400 may be inserted into the stretchable substrates 600-1, 600-2, and 600-3, and the remaining portion of the sensor guide 400 may be exposed to the outside of the stretchable substrates 600-1, 600-2, and 600-3. Thus, the sensor's electrodes 310, 320, and 330 may be stably fixed to the stretchable substrates 600-1, 600-2, and 600-3. For example, the length of the sensor guide 400 exposed to the outside of the stretchable substrates 600-1, 600-2, and 600-3 may be greater than the length of the sensor guide 400 inserted into the stretchable substrates 600-1, 600-2, and 600-3. Therefore, the electrodes 310, 320, and 330 of the sensor can be inserted into the body, thereby increasing the contact area with the tissue fluid.

[0121] The connection terminal 350 of the sensor may be connected to a signal processing unit, and the signal processing unit may perform signal processing on the amount of current received from the electrodes 310, 320, and 330 of the sensor through the connection terminal 350. The signal processing unit may be connected to a transmission unit, and the signal processed by the signal processing unit may be transmitted to the outside through the transmission unit.

[0122] For this reason, Figure 13 As shown, the connection terminal 350 of the sensor can be connected to the wiring 620-1 and 620-2 of the stretchable substrate 600-3, and the wiring 620-1 and 620-2 can be directly or indirectly connected to the signal processing unit. As shown in Figures 4(b), 5(a), 6(a), 7(a), and 7(b), in the substrate 300 of the sensor 110, the width of the connection terminal area where the connection terminal 350 is provided can be greater than the width of the electrode area where the electrodes 310, 320, and 330 are provided. For example, in the substrate 300 of the sensor 110, the width of the connection terminal area where the connection terminal 350 is provided can be greater than 1 times and no greater than 5 times the width of the electrode area where the electrodes 310, 320, and 330 are provided, and can preferably be greater than 1.5 times and less than 4 times the width of the electrode area, and can more preferably be greater than 2 times and less than 3.5 times the width of the electrode area. Therefore, the connection terminal can be stably bonded to the stretchable substrate 600-3, and when the sensor is injected into the body, it can prevent the sensor from detaching. In the substrate 300 of the sensor 110, when the width of the connection terminal area where the connection terminal 350 is provided is greater than 5 times the width of the electrode area where the electrodes 310, 320 and 330 are provided, the user may feel irritation because the area of ​​the non-stretchable substrate 300 is too wide.

[0123] As mentioned above, Figure 13 As shown, the wiring 620 may include a plurality of pads and a connector for connecting the plurality of pads, and the connection terminal 350 of the sensor 110 may be provided between two wiring layers of the plurality of wiring layers. In this case, the connection terminal 350 may be bonded to the pad of the wiring 620-2 via an adhesive portion 640. The adhesive portion 640 may be a solder ball or a plating layer, and the plating layer may include at least one selected from gold (Au), silver (Ag), copper (Cu), nickel (Ni), palladium (Pd), and chromium (Cr). According to an embodiment of the present invention, the width of the connection terminal 350 may be different from the width of the pad of the wiring 620-2. For example, the width of the adhesive portion 640 may be between the width of the connection terminal 350 and the width of the pad of the wiring 620-2.

[0124] like Figure 13 As shown, the signal processing unit 120 (see Figure 3 ) and the transmission unit 130 (see Figure 3 ) chips 700 and 800 can be set on one of the stretchable substrates 600-1, 600-2, 600-3 and 600-4 stacked into multiple layers, for example, the fourth stretchable substrate 600-4.

[0125] That is, the signal processing unit and the transmission unit may be electrically connected to the layer of the wiring 620 - 2 connected to the connection terminal 350 .

[0126] Here, the signal processing unit 700 and the transmission unit 800 can be chips implemented as integrated circuits. In this case, the signal processing unit 700 can include a signal processing chip 720 provided on a hard printed circuit board (PCB) 710. Therefore, even when the stretchable substrate 600-4 is bent or stretched / contracted by an external force, it can still minimize the problem of damage to the signal processing chip 720 due to the bending or stretching / contraction of the stretchable substrate 600-4. Similarly, the transmission unit 800 can also be implemented in the form of a transmission chip provided on a hard PCB.

[0127] Alternatively, as Figure 14 As shown, the signal processing unit 700 can be formed on the substrate 300 of the sensor. For example, a signal processing circuit pattern for processing the signal received from the electrode through the connection terminal 350 can be further provided on the surface of the two surfaces of the substrate 300 on which the connection terminal 350 of the sensor is provided. That is, the signal processing unit 700 can be implemented in the form of a flexible PCB (FPCB) on the substrate 300 of the sensor. The signal processing unit 700 can be connected to the transmission unit 800 provided on the fourth layer of the stretchable substrate 600-4. Therefore, the signal processing unit 700 and the sensor can be easily connected.

[0128] Figure 15 is an image of a sensing device according to one embodiment of the present invention.

[0129] refer to Figure 15 It can be seen that the sensing device according to an embodiment of the present invention includes a sensor and a stretchable substrate, the connecting terminal of the sensor is connected to the stretchable substrate, and the electrode of the sensor is arranged together with the sensor guide on the outside of the stretchable substrate.

[0130] While the present invention has been described with reference to exemplary embodiments, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. A sensing device comprising: A sensor comprising a flexible substrate, electrodes disposed on the flexible substrate, and connection terminals disposed on the flexible substrate and connected to the electrodes; as well as a stretchable substrate connected to the sensor and comprising a stretchable base and wiring disposed on the stretchable base, wherein the connection terminal of the sensor is connected to the wiring of the stretchable substrate, Wherein, the wiring comprises a plurality of stacked wiring layers, wherein at least one of the plurality of wiring layers comprises a support layer embedded in the stretchable substrate and a metal layer disposed on the support layer, and Wherein, the connecting terminal is arranged on the metal layer.

2. The sensing device according to claim 1, wherein: The connection terminal of the sensor is provided between two wiring layers among the plurality of wiring layers.

3. The sensing device according to claim 2, wherein: The stretchable substrate is disposed between adjacent wiring layers among the plurality of wiring layers.

4. The sensing device according to claim 1, wherein At least a portion of the sensor is inserted into the stretchable substrate, and a remaining portion of the sensor is extended from the stretchable substrate.

5. The sensing device according to claim 4, wherein The electrodes of the sensor are led out from the stretchable substrate, housed in a biodegradable sensor guide, and injected into the body together with the biodegradable sensor guide.

6. The sensing device according to claim 5, wherein: A portion of the biodegradable sensor guide is inserted into the stretchable substrate, and a remaining portion of the biodegradable sensor guide is exposed outside the stretchable substrate.

7. The sensing device according to claim 1, wherein: The flexible substrate is divided into an electrode area where the electrodes are provided and a connection terminal area where the connection terminals are provided; and The width of the connection terminal region is greater than the width of the electrode region.

8. The sensing device according to claim 1, wherein: The wiring of the stretchable substrate includes a plurality of pads and a connector configured to connect the plurality of pads; and The width of the connection terminal is different from the width of the pad. 9 . The sensing device according to claim 8 , further comprising an adhesive portion provided between the connection terminal and the pad.

10. The sensing device according to claim 4, wherein: The plurality of wiring layers include a first wiring layer and a second wiring layer, the first wiring layer facing a first surface of the flexible substrate on which the connection terminals of the sensor are provided, and the second wiring layer facing a second surface opposite to the first surface; The sensing device further includes at least one of a signal processing unit and a transmission unit connected to the first wiring layer and buried in the stretchable substrate.

11. The sensing device according to claim 2, wherein: A signal processing circuit pattern configured to process a signal received from the electrode through the connection terminal is further provided on a first surface of the two surfaces of the flexible substrate where the connection terminal of the sensor is provided.

12. The sensing device according to claim 2, wherein: The flexible substrate includes a first surface and a second surface opposite to the first surface; At least one of a reference electrode, a working electrode, and an auxiliary electrode is disposed on the first surface and the second surface; and A plurality of connection terminals identical to the connection terminals are provided on at least one of the first surface and the second surface.

13. The sensing device according to claim 2, wherein: The flexible substrate includes a first surface and a second surface opposite to the first surface, and is wound in a spiral shape such that the first surface faces outward and the second surface faces inward; and At least one of a reference electrode, a working electrode, and an auxiliary electrode is disposed on the first surface and the second surface.

14. The sensing device according to claim 2, wherein: The flexible substrate includes a first surface and a second surface opposite to the first surface, and is wound in a spiral shape such that the first surface faces outward and the second surface faces inward; at least one reference electrode disposed on the first surface; and At least one working electrode and at least one auxiliary electrode are disposed on the second surface.

15. The sensing device according to claim 1, wherein The metal layer includes at least one of Au, Cu, Pt and Ag, and the support layer includes at least one of LCP (liquid crystal polymer), PEEK (polyetheretherketone) and PI (polyimide).

16. The sensing device according to claim 8, wherein The connector includes a repeating meander pattern.

17. The sensing device according to claim 10, wherein: At least one of the signal processing unit and the transmission unit includes a hard PCB and a chip disposed on the hard PCB.

Images