Sensor device, catheter, and system including the sensor device

By integrating pressure sensors and temperature sensors in the front end side member of the urethral catheter, the problem of increasing the outer diameter of the catheter to the patient is solved, and a miniaturized and high-precision sensor system is realized, reducing the burden on patients.

CN112261900BActive Publication Date: 2025-01-03SEMITEC
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Patent Information

Application Number
CN201980039765.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2018-07-13
Filing Date
2019-06-12
Publication Date
2025-01-03
Estimated Expiration
2039-06-12

AI Technical Summary

Technical Problem

When measuring deep body temperature and internal bladder pressure, existing urethral catheters need to use temperature sensors and pressure sensors separately, resulting in an increase in the outer diameter of the catheter, which is burdened to the patient and is difficult to miniaturize.

Method used

A miniaturized sensor device is designed, by integrating the pressure sensor and temperature sensor in the front-end member, and coating it with an integrated substrate configuration and polyamide resin to form a miniaturized tubular structure to reduce the outer diameter of the catheter. , improve suitability.

Benefits of technology

The miniaturized sensor devices and catheters are achieved, reducing the burden on patients, and improving measurement accuracy and comfort through integrated structures.

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Abstract

The present invention provides a miniaturized sensor device, a catheter, and a system including the sensor device. The sensor device (1) includes: a tubular front end member (23); a pressure sensor (4) and a temperature sensor (5), which are accommodated in the inner space of the front end member (23) and integrated; and a lead wire (6), which is connected to the pressure sensor (4) and the temperature sensor (5) and is led out toward the rear end. The pressure sensor (4) and the temperature sensor (5) are respectively formed with a sensor element (41) and a sensor element (51) on one side of a substrate (42) and a substrate (52), and are arranged in a manner that the other sides of their respective substrates (42) and substrates (52) face each other and are integrated.
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Description

Technical Field

[0001] The present invention relates to a sensor device, a catheter and a system comprising the sensor device. Background Art

[0002] Conventionally, for example, in the field of medical equipment, temperature sensors are used to measure deep body temperature, and pressure sensors are used to measure pressure in a body cavity. As a specific example, when a urethral catheter is applied to a patient, deep body temperature and bladder pressure are measured to monitor the biological environment.

[0003] Urethral catheters are generally used to insert the catheter from the patient's urethra into the bladder to discharge urine continuously. In this case, the intra-bladder pressure is roughly related to the intra-abdominal pressure, so the intra-abdominal pressure can be estimated by monitoring the intra-bladder pressure, and the postoperative complications caused by the rapid increase of the intra-abdominal pressure can be diagnosed. Furthermore, by analyzing the intra-bladder pressure, information such as urine output, respiratory rate, heart rate, and heart rate fluctuation can be obtained.

[0004] When measuring deep body temperature and intravesical pressure, there is a method of preparing different catheters to measure deep body temperature (temperature sensor) and intravesical pressure (pressure sensor). However, this method is a heavy burden on the patient, and an appropriate method with less burden is needed.

[0005] On the other hand, it is possible to install both a temperature sensor and a pressure sensor at the front end of the urethral catheter to simultaneously measure the deep body temperature and the intravesical pressure. However, according to the above structure, the outer diameter of the catheter becomes larger, which increases the burden on the patient, thus causing a problem of difficulty in practical adoption.

[0006] Prior art literature

[0007] Patent Literature

[0008] Patent Document 1: Japanese Patent Application Publication No. 2001-25461

[0009] Patent Document 2: Japanese Patent Publication No. 2000-502275

[0010] Patent Document 3: Japanese Patent Publication No. 2009-523463

[0011] Patent Document 4: Japanese Patent Publication No. 2017-536857 Summary of the invention

[0012] Problems to be solved by the invention

[0013] The present invention has been made in view of the above-mentioned problems, and an object of the present invention is to provide a sensor device, a catheter, and a system including the sensor device that can be miniaturized.

[0014] Technical means of solving problems

[0015] The sensor device of this embodiment includes: a tubular front end member; a pressure sensor and a temperature sensor, which are accommodated in the inner space of the front end member and integrated; and a lead wire, which is connected to the pressure sensor and the temperature sensor and led out toward the rear end. In addition, the pressure sensor and the temperature sensor each have a sensor element formed on one side of a substrate, are arranged in a manner that the other sides of the respective substrates face each other, and are integrated.

[0016] According to the structure, a miniaturized sensor device can be provided. Integration includes, for example, a configuration in which only the other side of each substrate is butted against each other, or a situation in which the other side is bonded. In other words, it means a state in which the pressure sensor and the temperature sensor are integrated. It is not particularly limited to be interpreted.

[0017] Effects of the Invention

[0018] According to the present invention, a sensor device, a catheter, and a system including the sensor device that can be miniaturized can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a front view showing a sensor device according to an embodiment of the present invention.

[0020] Figure 2 is a top view showing the sensor device.

[0021] Figure 3 It is a cross-sectional view for explaining the structure of the front end portion of the sensor device.

[0022] Figure 4 is a top view of the front end portion of the sensor device.

[0023] Figure 5 is a bottom view of the front end portion of the sensor device.

[0024] Figure 6 yes Figure 3 , a cross-sectional view along line YY.

[0025] Figure 7 1 is a schematic cross-sectional view showing a pressure sensor.

[0026] Figure 8 1 is a schematic cross-sectional view showing a temperature sensor.

[0027] Fig. 9 This is a bridge circuit diagram (half-bridge circuit) showing the connection state of the pressure sensor.

[0028] Fig.10 This is a bridge circuit diagram (full bridge circuit) showing the connection state of the pressure sensor.

[0029] Fig.11 This is a front view showing a state where the sensor device has been installed in the urethral catheter.

[0030] Fig.12 yes Fig.11 , a cross-sectional view along line YY.

[0031] Fig.13 It is a front view showing a system including a sensor device.

[0032] Fig.14 It is a front view showing a system including a sensor device.

[0033] Explanation of symbols

[0034] 1: Sensor devices

[0035] 2: Body part

[0036] 3: Connection terminal

[0037] 4: Pressure sensor

[0038] 5: Temperature sensor

[0039] 6: Lead wire

[0040] 7: Cover member

[0041] 10: Urethral catheter

[0042] 11: Base

[0043] 12: Axis

[0044] 15: Airbag

[0045] 21: Front end

[0046] 22: Lead-out

[0047] 23: Front end side member

[0048] 23a: Opening

[0049] 41: Sensor element (pressure sensor)

[0050] 42: Substrate (pressure sensor)

[0051] 51: Sensor element (temperature sensor)

[0052] 52: Substrate (temperature sensor)

[0053] 61: Resin tube

[0054] 71: Insulating materials

[0055] 72: Insulating materials

[0056] 100: System

[0057] 101: Control Devices

[0058] 111: Airbag funnel

[0059] 112: Cleaning water funnel

[0060] 113: Funnel for urination

[0061] 114: Sensor Funnel

[0062] 131: Urinary hole

[0063] 132: Hole for washing water outflow DETAILED DESCRIPTION

[0064] Below, refer to Figures 1 to 10 A sensor device according to an embodiment of the present invention will be described. Figure 1 This is a front view showing the sensor device. Figure 2 is a top view showing a sensor device. Figure 3 is a cross-sectional view for explaining the structure of the front end portion of the sensor device. Figure 4 is a top view of the front end of the sensor device, Figure 5 This is a bottom view of the front end of the sensor device. Figure 6 yes Figure 3 In the cross-section diagram along line YY, Figure 7 and Figure 8 It is a schematic cross-sectional view showing a pressure sensor and a temperature sensor. Fig. 9 and Fig.10 It is a bridge circuit diagram showing the connection state of the pressure sensor. In addition, in each figure, in order to make each component become a recognizable size, the scale of each component is appropriately changed.

[0065] The sensor device of this embodiment includes a miniaturized pressure sensor and a temperature sensor, and is configured to be appropriately incorporated into a catheter. The pressure sensor is a sensor for measuring the pressure in a body cavity, and the temperature sensor is a sensor for measuring deep body temperature.

[0066] like Figures 1 to 3As shown, the sensor device 1 includes: a main body portion 2 having a long strip shape and flexibility, and a connection terminal portion 3 connected to the main body portion 2. The main body portion 2 includes a front end portion 21 and a lead portion 22, and the pressure sensor 4 and the temperature sensor 5 described later are arranged at the front end portion 21. The lead portion 22 is a portion where a plurality of lead wires 6 connected to the pressure sensor 4 and the temperature sensor 5 extend. The lead wire 6 is a lead wire with a core wire covered with insulation, and further, the plurality of lead wires 6 are gathered into one by being covered with insulation by a resin tube 61. That is, the plurality of lead wires 6 are accommodated in the inner space of the resin tube 61. The material of the resin tube 61 is polyamide resin.

[0067] The length of the main body 2 is about 1000 mm, and the outer diameters φ of the front end 21 and the lead-out portion 22 are formed to be 1.5 mm or less, preferably 1 mm or less.

[0068] The connection terminal portion 3 is a portion to which the lead-out end portion of the lead wire 6 is connected, and is composed of a resin-made, substantially rectangular housing that contains electronic components such as a circuit substrate. Specifically, the connection terminal portion 3 is provided with a detection control circuit or an amplifier circuit of the pressure sensor 4 and the temperature sensor 5. In addition, a Universal Serial Bus (USB) terminal 31 as an input / output terminal is provided on one side of the connection terminal portion 3. By connecting the USB terminal 31 to a control device such as a monitor, the detection information output by the pressure sensor 4 and the temperature sensor 5 can be monitored.

[0069] Then, refer to Figures 3 to 8 , the structure of the front end portion 21 in the main body 2 in which the pressure sensor 4 and the temperature sensor 5 are arranged will be described. The front end portion 21 is provided with: a tubular front end side member 23, the pressure sensor 4 and the temperature sensor 5 arranged in the inner space of the tubular front end side member 23, and a plurality of lead wires 6 connected to the pressure sensor 4 and the temperature sensor 5 and led out toward the rear end side.

[0070] The front end side member 23 is made of stainless steel material, formed into a tubular shape, and has an opening 23a near the front end. The opening 23a is formed by cutting a part of the outer periphery of the tubular shape. The length dimension of the front end side member 23 is about 4mm, and the outer diameter φ is formed to be less than 1.5mm, preferably less than 1mm. Therefore, the inner diameter φ is formed to be at least less than 1.5mm, preferably less than 1mm.

[0071] The pressure sensor 4 and the temperature sensor 5 are arranged in the narrow inner space of the front end member 23. The pressure sensor 4 is a semiconductor pressure sensor, and has a sensor element 41 having a function of a strain gauge whose resistance value changes due to displacement when pressure is applied. The sensor element 41 is a piezoresistive element formed on one side of a substrate 42 made of silicon material.

[0072] The temperature sensor 5 is a thin film thermistor having a sensor element 51 whose resistance value changes with temperature. The sensor element 51 is a thermistor thin film including an oxide semiconductor having a negative temperature coefficient, and the thermistor thin film is formed on one surface of a substrate 52 including a ceramic material.

[0073] In addition, an electrode layer is formed on the substrate 42 of the pressure sensor 4 and the substrate 52 of the temperature sensor 5, and the lead wire 6 is connected to the electrode layer by welding or fusion. When the lead wire 6 is joined to the electrode layer by fusion, additional materials such as solder can be omitted compared to the case of welding, so the wall thickness of the joint can be reduced.

[0074] The pressure sensor 4 and the temperature sensor 5 as described above are arranged so that the other sides of the respective substrates 42 and 52 face each other and are integrated. Thus, the structure of the sensor group having the pressure sensor 4 and the temperature sensor 5 is miniaturized. Here, integration includes, for example, a configuration in which the other sides of the substrates 42 and 52 are merely butted against each other, or a case in which the other sides of the substrates 42 and 52 are bonded. In other words, it means a state in which the pressure sensor 4 and the temperature sensor 5 are integrated.

[0075] Specifically, the integrated pressure sensor 4 and temperature sensor 5 are inserted and arranged in the front end member 23 via a cap member 7 made of polyimide resin and in a tubular shape. In addition, an insulating material 71 is filled in the cap member 7, and the surroundings including the joints of the pressure sensor 4, the temperature sensor 5 and the lead wire 6 are insulated. The insulating material 71 filled in the cap member 7 can be preferably epoxy resin, but it is not limited to epoxy resin as long as the function is fully satisfied.

[0076] In more detail, the formation position of the sensor element 41 in the pressure sensor 4 and the formation position of the sensor element 51 in the temperature sensor 5 are staggered. The substrate 42 of the pressure sensor 4 protrudes toward the front end side more than the substrate 52 of the temperature sensor 5, and the area of ​​the formation position of the sensor element 41 in the pressure sensor 4 becomes a structure that is not covered with the insulating material 71. On the other hand, the area of ​​the formation position of the sensor element 41 in the pressure sensor 4 is covered with the insulating material 72 of the silicone rubber film through the silicone coating, thereby ensuring insulation. In addition, the sensor element 41 is arranged in a manner facing the opening 23a of the front end side member 23. In addition, the resin tube 61 accommodating a plurality of lead wires 6 is inserted into the inner periphery of the rear end side of the front end side member 23 and fixed by the adhesive material 62. As the adhesive material 62, for example, epoxy resin can be used.

[0077] The formation position of the sensor element 41 in the pressure sensor 4 and the formation position of the sensor element 51 in the temperature sensor 5 are staggered as described above to avoid the possibility of affecting each other's detection characteristics. In addition, the insulating material 72 covering the area where the sensor element 41 in the pressure sensor 4 is formed and the insulating material 71 covering the area where the sensor element 51 in the temperature sensor 5 is formed are different materials. The reason is that both the pressure sensor 4 and the temperature sensor 5 ensure insulation, while in the case of the pressure sensor 4, it is necessary to use the insulating material 72 with flexibility in order to detect pressure.

[0078] Furthermore, the pressure sensor 4 and the temperature sensor 5 are arranged in the cover member 7. Therefore, when the pressure sensor 4 and the temperature sensor 5 are inserted into the front end side member 23, the inner periphery of the front end side member 23 can be used as a guide to insert into the cover member 7, so it can be expected that the assembly process will become easier.

[0079] Then, refer to Figure 7 and Figure 8 , the schematic structure of the pressure sensor 4 and the temperature sensor 5 is described. Figure 7 As shown, the pressure sensor 4 is made by processing a silicon semiconductor material using a micro electromechanical system (MEMS) technology. A cavity 43 is formed on a silicon substrate 42, and a piezoresistive element as a sensor element 41 is formed on a silicon layer 44 on the cavity 43. When forming the piezoresistive element, an ion implantation method, which is a semiconductor process technology for implanting impurity ions into the silicon layer 44, is applied to implant boron into the silicon layer 44 to form the piezoresistive element.

[0080] In addition, a pair (two) of piezoresistive elements as sensor elements 41 are formed on the silicon layer 44. This is to form a bridge circuit in the connection of the pressure sensor 4 as described later to achieve high sensitivity. Furthermore, on the rear end side of the silicon substrate 42, electrode layers 45 (also referred to as Figure 4 ), these electrode layers 45 are electrically connected to the piezoresistive element through an internal wiring pattern not shown. In addition, the lead wires 6 are welded to the electrode layers 45 by welding or a so-called pulse heating method. The thickness dimension of the substrate 42 of the pressure sensor 4 is 100 μm or less, and the total thickness dimension including the electrode layer 45 is formed to be 150 μm or less.

[0081] The pressure sensor 4 is a sensor in which when pressure is applied to a piezoresistive element by utilizing the action of the cavity 43 as a diaphragm, the resistance value of the piezoresistive element changes due to displacement, and the pressure is detected by processing the change with an electronic circuit.

[0082] like Figure 8 As shown, the temperature sensor 5 is a surface mount type sensor, including a substrate 52, an electrode layer 53, a thermosensitive film as a sensor element 51, and a protective film 54. The temperature sensor 5 is a thin film thermistor, and the total thickness is 100 μm or less.

[0083] The substrate 52 is formed using insulating ceramic materials such as zirconium oxide, silicon nitride, aluminum oxide, or a mixture of at least one of them. The thickness dimension of the substrate 52 is thinned to less than 100 μm, preferably to 10 μm to 80 μm. In addition, the bending strength of the substrate 52 is above 690 MPa, and the average particle size of the ceramic material after calcination is 0.1 μm to 2 μm. By setting the range of the average particle size in this way, a bending strength of more than 690 MPa can be ensured, and breakage during the production of the thinned substrate 52 can be suppressed. In addition, since the thickness dimension of the substrate 52 is thin, the heat capacity can be reduced.

[0084] The electrode layer 53 is a pair of portions formed on the substrate 52 and electrically connected to the thermosensitive film. The pair of electrode layers 53 is formed by forming a metal thin film with a thickness of less than 1 μm using a thin film forming technique such as sputtering, and the metal material used is a precious metal such as gold (Au), silver (Ag), copper (Cu), platinum (Pt), palladium (Pd), or an alloy thereof, such as an Ag-Pd alloy.

[0085] In addition, the pair of electrode layers 53 is a portion joined to the lead wire 6 by welding, and as a low melting point metal, gold (Au: melting point 1064°C), silver (Ag: 961°C), copper (Cu: 1085°C) or an alloy containing at least one of them as a main component is preferably used. In addition, in this embodiment, the electrode layer 53 is formed under the film of the thermosensitive film, but it can also be formed on the film or in the film of the thermosensitive film.

[0086] The thermosensitive film is a heat-sensitive thin film and a thin film of a thermistor. The thermosensitive film is formed on the electrode layer 53 by a thin film forming technique such as sputtering, and is electrically connected to the electrode layer 53 .

[0087] The protective film 54 covers the area where the thermosensitive film is formed, and is formed so as to expose at least a portion of the electrode layer 53 and covers the electrode layer 53. The protective film 54 can be formed by forming a film of silicon dioxide, silicon nitride, etc. using a thin film forming technique such as a sputtering method, or can be formed by forming lead glass, borosilicate glass, lead borosilicate glass, etc. using a printing method.

[0088] The lead wire 6 is made of a low melting point metal, that is, a metal having a melting point of 1300° C. or less, such as a copper alloy containing copper as a main component, such as phosphor bronze, constantan, or manganese bronze.

[0089] When the electrode layer 53 of the temperature sensor 5 and the lead wire 6 are joined by laser welding, for example, the lead wire 6 has a melting point of 1300°C or less, and therefore, even if it is melted by heating with laser light or the like, the temperature does not reach a melting point of 1300°C or more. Therefore, the melting point of the ceramic substrate 52 of 1600°C to 2100°C does not exceed the temperature, and the lead wire 6 can be joined while suppressing damage to the electrode layer 53 of the temperature sensor 5 or the substrate 52 directly below the electrode layer 53. In addition, in this case, no additional material such as a bump is used, so that the connection is not performed in a state where the additional material is substantially added to the connection (joining) portion, and the heat capacity does not increase, and the thermal responsiveness can be made high.

[0090] In the past, the lead wires described above were made of iron-based metals such as stainless steel, Kovar, and nickel alloys. The iron-based metals have high melting points. For example, stainless steel and Kovar are both iron-based alloys, so the temperature sometimes rises to about 1538°C, which is the melting point of iron. If the lead wires made of such high-melting-point metals are irradiated with laser light for laser welding, the lead wires and their surroundings are heated to a high temperature, and the insulating substrate (such as an alumina substrate) is easily damaged. According to the structure of the present embodiment, this problem can be solved.

[0091] The temperature sensor 5 is a sensor whose resistance value changes due to a change in temperature, and the change is processed by an electronic circuit to detect the temperature.

[0092] On the other hand, in wearable devices for monitoring biological information and catheters as medical devices, when the risk of exposure of these devices to the living body is high, materials used are required to include materials that take biocompatibility into consideration. In this embodiment, stainless steel is used for the front end member 23, silicon substrate 42 is used for the pressure sensor 4, ceramic substrate 42 is used for the temperature sensor 5, polyimide resin is used for the cover member 7, epoxy resin is used for the insulating material 71 in the cover member 7, polyamide resin is used for the resin tube 61, and silicone rubber is used for the coating of the pressure sensor 4. These materials have been confirmed to be biocompatible and can ensure safety.

[0093] Then, refer to Fig. 9 and Fig.10 Describe the connection status of the pressure sensor. Fig. 9 As shown, the pressure sensor 4 and the power supply V + Specifically, it is a half-bridge circuit, in which the series circuit of the sensor element 41a and the reference resistor 46a of the pressure sensor 4 and the series circuit of the sensor element 41b and the reference resistor 46b are connected to the power supply V + In addition, an output terminal is connected in the middle of each series circuit, and the output terminal is connected to an amplifier Amp, and the differential output can be detected as an output voltage Vout. Therefore, a signal of a slight pressure change can also be detected.

[0094] In this connection state, the sensor elements 41 a and 41 b of the pressure sensor 4 are arranged on the front end member 23 , and the reference resistors 46 a and 46 b and the amplifier Amp are accommodated in the connection terminal portion 3 .

[0095] Fig.10 The bridge circuit is configured as a full bridge circuit. Four sensor elements of the pressure sensor 4 are provided, and a series circuit of sensor elements 41a and 41b and a series circuit of sensor elements 41c and 41d are connected to a power supply V + Connect in parallel. Therefore, higher sensitivity detection is possible.

[0096] In this connection state, the sensor elements 41 a , 41 b , 41 c , and 41 d of the pressure sensor 4 are arranged on the front end member 23 , and the amplifier Amp is accommodated in the connection terminal portion 3 .

[0097] In addition, it is also desirable to form a bridge circuit for the connection of the temperature sensor 5. In this case, although not shown in the figure, for example, a series circuit of the detection sensor element 51 and the detection resistor, and a series circuit of the compensation sensor element and the compensation resistor are connected to the power supply V + In addition, an output terminal is connected in the middle of each series circuit, and the output terminal is connected to an amplifier Amp, and the differential output is detected as an output voltage Vout. With this structure, a signal with a small temperature change can also be detected.

[0098] Then, refer to Figures 11 to 14 , a catheter in which the sensor device 1 is installed and a system including the sensor device 1 are described. Fig.11 is a front view showing a state where the sensor device has been installed in the urethral catheter. Fig.12 yes Fig.11 In the cross-section diagram along line YY, Fig.13 and Fig.14 Represents a system including a sensor device.

[0099] The catheter of this embodiment is a urethral catheter, which is inserted from the urethra of a patient into the bladder for the purpose of continuously draining urine, and includes a balloon, and is used with the front end of the catheter left in the bladder.

[0100] like Fig.11 and Fig.12 As shown, the urethral catheter 10 includes a base 11 and a shaft 12 extending continuously from the base 11. The catheter 10 is, for example, a four-way type, and has a total length of about 250 mm to 430 mm. The base 11 is provided with a balloon funnel 111, a washing water funnel 112, a urination funnel 113, and a sensor funnel 114.

[0101] The shaft 12 has four lumens corresponding to the funnels 111, 112, 113, and 114, and has appropriate rigidity and flexibility. In addition, the pressure sensor 4 and the temperature sensor 5 of the sensor device 1 are arranged at the front end 13 of the shaft 12, and a urination hole 131 and a washing water outflow hole 132 are formed. Furthermore, an air bag 15 is provided near the rear end of the front end 13 of the shaft 12.

[0102] A syringe is connected to the balloon funnel 111, and air or sterilizing water is injected to expand the balloon 15. A syringe is connected to the cleaning water funnel 112 as needed to supply cleaning water into the bladder to clean the bladder. A urine collection bag is connected to the urination funnel 113 to discharge urine in the bladder to the outside of the body and store urine in the urine collection bag. Lead wires 6 of the pressure sensor 4 and the temperature sensor 5 arranged at the front end 13 of the shaft 12 are led out from the sensor funnel 114.

[0103] Among the four lumens, the first lumen 121 is a lumen that serves as a flow path through which the air delivered from the balloon funnel 111 passes, and is connected to the balloon 15, and the balloon 15 is inflated by the air delivered through the first lumen 121. The second lumen 122 is a lumen that serves as a flow path through which the washing water delivered from the washing water funnel 112 passes, and is connected to the washing water outflow hole 132, and the washing water delivered through the second lumen 122 flows out from the washing water outflow hole 132. The third lumen 123 is connected to the urination hole 131, and serves as a lumen that serves as a flow path through which urine flowing out of the patient's bladder passes.

[0104] The fourth lumen 124 is a portion through which the lead wires 6 of the pressure sensor 4 and the temperature sensor 5 are inserted. The pressure sensor 4 and the temperature sensor are arranged at the front end 13 of the shaft 12. The lead wires 6 pass through the fourth lumen 124 and the connection terminal 3 is led out to the outside. In this way, the sensor device 1 is installed in the catheter 10.

[0105] The outer diameter of the shaft 12 is about 12 Fr to 24 Fr, and the shaft 12 may be made of a synthetic resin such as polyurethane, polyolefin, polyamide, polyether polyamide, or silicone rubber.

[0106] Fig.13 1 represents a system including a sensor device. The system 100 includes a catheter 10 in which a sensor device 1 is installed, and a control device 101. The control device 101 is a monitor suitable for the YSI-400 specification, and is equipped with a microcomputer, the microcomputer including a display unit, a central processing unit (CPU) having a calculation unit and a control unit, a read-only memory (ROM) and a random access memory (RAM) as a storage unit, and an input / output control unit, and can be connected to a USB terminal 31 of the connection terminal unit 3 in the sensor device 1. Therefore, by connecting the sensor device 1 to the control device 101, biological information including bladder pressure and body temperature can be displayed.

[0107] Fig.14 The structure in which the sensor device and the control device connected to the sensor device are connected via a wireless line. The control device 101a is provided with a wireless transceiver, and the connection terminal portion 3a is provided with a wireless module or a built-in battery. Therefore, biological information can be sent from the connection terminal portion 3a to the control device 101a via wireless, and the biological information can be displayed by the control device 101a.

[0108] Therefore, by wirelessly connecting the sensor device 1 and the control device 101a, there is an advantage that lead wires and the like do not become an obstacle during surgery, and handling becomes easy.

[0109] Next, the treatment of the urethral catheter 10 for the patient will be described. First, the urine collection bag is connected to the urination funnel 113, and the catheter 10 is inserted from the patient's urethral opening. After confirming that the balloon 15 has reached the bladder and urine has flowed out of the catheter 10, a syringe is connected to the balloon funnel 111, and air or sterile water is injected into the balloon 15 to expand the balloon 15. The catheter 10 is pulled out before the balloon 15 contacts the bladder neck, and the front end 13 of the catheter 10 is left in the bladder. Then, the USB terminal 31 of the connection terminal part 3 is connected to the control device 101. In this way, urine is continuously discharged to the outside of the body and stored in the urine collection bag.

[0110] Specifically, urine in the bladder flows from the urination hole 131 through the third lumen 123 and reaches the urine collection bag. In addition, since the pressure sensor 4 and the temperature sensor 5 disposed at the front end portion 13 of the shaft 12 of the sensor device 1 remain in the bladder, the pressure in the bladder is measured by the pressure sensor 4, and the deep body temperature is measured by the temperature sensor 5, and the detection signals of both are sent to the control device 101. In this case, since the opening 23a of the front end side member 23 faces the pressure sensor 4, the pressure in the bladder can be detected with high accuracy by the pressure sensor 4 through the urine flowing in from the urination hole 131. In this way, the control device 101 displays the pressure in the bladder and the deep body temperature, and biological information can be monitored.

[0111] Furthermore, if necessary, a syringe is connected to the cleaning water funnel 112, and the cleaning water is made to flow out from the cleaning water outflow hole 132 into the bladder to clean the inside of the bladder.

[0112] As described above, according to the present embodiment, it is possible to provide the sensor device 1 which can be miniaturized, and to realize a catheter which can reduce the burden on the patient.

[0113] In addition, the sensor device of the present invention can be suitably used in a catheter, but is not limited thereto. It can also be applied to other medical devices. Furthermore, it can be applied not only to the field of medical devices, but also to devices and apparatuses that require miniaturization, including pressure sensors and temperature sensors.

[0114] The present invention is not limited to the structure of the embodiment, and various modifications can be made within the scope of the subject matter of the invention. In addition, the embodiment is an embodiment presented as an example, and is not intended to limit the scope of the invention. These new embodiments can be implemented in various other forms, and various omissions, substitutions, and changes can be made. These embodiments or their modifications are included in the scope or subject matter of the invention, and are included in the invention described in the claims and their equivalents.

Claims

1. A sensor device, characterized in that: include: a tubular front end side member; A pressure sensor and a temperature sensor are housed in the inner space of the tube of the front end side member, wherein the pressure sensor and the temperature sensor are respectively formed with sensor elements on one side of a substrate, are arranged in a manner of butting against the other side of each substrate, and are integrated into an integrated structure, and when viewed along the axial direction of the front end side member, the integrated structure overlaps the center of the front end side member; as well as The lead wires are connected to the pressure sensor and the temperature sensor and are led out toward the rear end side.

2. The sensor device according to claim 1, characterized in that A formation position of the sensor element in the pressure sensor is shifted from a formation position of the sensor element in the temperature sensor.

3. The sensor device according to claim 1 or 2, characterized in that: The pressure sensor is made of semiconductor material, and the temperature sensor is a thin film thermistor.

4. The sensor device according to claim 1 or 2, characterized in that: The inner diameter of the front end side member is less than 1 mm.

5. The sensor device according to claim 1 or 2, characterized in that: The lead-out end portion of the lead wire is connected to a connection terminal portion having an input / output terminal.

6. The sensor device according to claim 1 or 2, characterized in that: The pressure sensor and the temperature sensor are housed in an inner space in the tube of the front end side member via a tubular cover member.

7. The sensor device according to claim 1 or 2, characterized in that: There are multiple lead wires, and the multiple lead wires are gathered into one by a resin tube for insulation coating.

8. The sensor device according to claim 1 or 2, characterized in that: The pressure sensor is a sensor for measuring the pressure in the body cavity, and the temperature sensor is a sensor for measuring the deep body temperature.

9. The sensor device according to claim 1 or 2, characterized in that: Biocompatible materials are used for the distal end member, the substrates included in the pressure sensor and the temperature sensor, and the insulating material covering the pressure sensor and the temperature sensor.

10. The sensor device according to claim 1 or 2, characterized in that: The pressure sensors are bridge-connected to form a bridge circuit.

11. The sensor device according to claim 10, characterized in that An amplifier is connected to the output end of the bridge circuit.

12. A catheter, characterized in that: A sensor device according to any one of claims 1 to 11 is incorporated.

13. A system comprising a sensor device, characterized in that: include: The sensor device according to any one of claims 1 to 11; as well as A control device is connected to the sensor device.

14. The system comprising a sensor device according to claim 13, characterized in that The sensor device is connected to the control device via a wireless link.