Catheter system

Abstract

To measure the behavior of a guide wire, and notify an operator of the measurement result.SOLUTION: A catheter system 200 comprises: a guide wire 10; a rod-like torquer 30 which is connected to the guide wire 10, and which is grasped by an operator when operating the guide wire 10; a strain gauge 70 provided to the torquer 30, for detecting the strain of the torquer 30; a notification unit for notifying the operator of the result of detection by the strain gauge 70; and a control unit for controlling operation by the notification unit. The control unit determines whether or not the result of detection by the strain gauge 70 exceeds a determination threshold. When it is determined that the detection result exceeds the determination threshold, the control unit makes comparison with the case where the detection result does not exceed the determination threshold, and causes the notification unit to issue a notification in an emphasized manner.SELECTED DRAWING: Figure 10

Description

[Technical field]

[0001] The present disclosure relates to a catheter system. [Background technology]

[0002] For example, a smart guidewire is known that includes a guidewire, a magnetic vector sensor grid, a position sensor data processing device, and a display device (see, for example, Patent Document 1). The magnetic vector sensor grid is provided on a diagnostic device placed outside the patient's body. The position sensor data processing device calculates the position and orientation of the tip of the guidewire using data measured by the magnetic vector sensor grid. The display device displays the measurement values ​​of the position and orientation calculated by the position sensor data processing device.

[0003] The smart guidewire also includes a strain gauge that measures the stress applied to the tip of the wire, and a stress sensor data processing device that calculates the contact pressure and bending stress at the tip of the wire, and displays the calculated values ​​of the contact pressure and bending stress on a display device.

[0004] The smart guidewire also includes a handle and a torquer. The handle is provided with a torque sensor that measures the torque applied to the handle. The torquer is provided with a torquer rotation amount measuring device that measures the amount of rotation of the torquer. The smart guidewire includes a rotation sensor data processing device that calculates the torque and the amount of rotation, and displays the calculated values ​​of the torque and the amount of rotation on a display device. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent Publication No. 2023-12701 Summary of the Invention [Problem to be solved by the invention]

[0006] In the conventional technology, torque sensors were attached to both the handle and the torquer to measure the wire feed amount and rotation amount. In addition, in the conventional technology, a distortion impedance (SI) was used as the torque sensor. This required a high-frequency pulse current, which inevitably increased the number of parts and made the circuit configuration complicated.

[0007] An object of the present disclosure is to provide a catheter system that includes a strain gauge with a simple configuration, measures the behavior of a guidewire, and notifies the operator of the measurement results. [Means for solving the problem]

[0008] The catheter system according to the present disclosure comprises a guidewire, a rod-shaped torquer connected to the guidewire and held by an operator when manipulating the guidewire, a strain gauge attached to the torquer and detecting strain in the torquer, an alarm unit that notifies the detection result by the strain gauge, and a control unit that controls the operation of the alarm unit, wherein the control unit determines whether the detection result by the strain gauge exceeds a judgment threshold, and if the detection result exceeds the judgment threshold, causes the alarm unit to notify the detection result in an emphasized manner compared to a case where the detection result does not exceed the judgment threshold. Effect of the Invention

[0009] The present disclosure can provide a catheter system that includes a strain gauge with a simple configuration, measures the behavior of a guidewire, and notifies the operator of the measurement results. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic diagram showing a catheter according to an embodiment. [Diagram 2] FIG. 1 is a cross-sectional view showing a torquer. [Diagram 3] An enlarged cross-sectional view of the tip of the torquer. [Figure 4] FIG. [Diagram 5]FIG. 1 is a side view (part 1) of the operating parts. [Figure 6] FIG. 2 is a side view (part 2) of the operating parts. [Figure 7] FIG. 3 is a side view (part 3) of the operating parts. [Figure 8] FIG. 4 is a side view of the operating parts. [Figure 9] FIG. [Figure 10] FIG. 2 is a block diagram showing the hardware configuration of the catheter system. [Figure 11] FIG. 2 is a functional block diagram of the catheter system. [Figure 12] FIG. 13 is a diagram showing an example of a display image in the catheter system. [Figure 13] FIG. 13 is a diagram showing an example of a display image in the catheter system. [Figure 14] 1 is a flowchart showing an example of a control processing procedure (part 1) in the catheter system. [Figure 15] 11 is a flowchart showing an example of a control processing procedure (part 2) in the catheter system. [Figure 16] FIG. 16(a) is a graph showing the relationship between the load and the absolute value of the output voltage, and FIG. 16(b) is a graph showing the relationship between the torque and the absolute value of the output voltage. [Figure 17] FIG. 2 is a diagram illustrating an example of a Wheatstone bridge circuit according to the first embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Hereinafter, a catheter according to an embodiment will be described with reference to the accompanying drawings. In this specification and the drawings, substantially the same components are designated by the same reference numerals, and redundant description may be omitted.

[0012] [Catheter 100 according to the embodiment] A catheter 100 according to an embodiment will be described. Fig. 1 is a schematic diagram showing a catheter according to an embodiment. Fig. 2 is a cross-sectional view showing a torquer 30. Fig. 3 is an enlarged cross-sectional view of the tip of the torquer. Fig. 4 is an exploded perspective view of the torquer 30. Figs. 5 to 8 are side views of the operating parts.

[0013] [Guidewire 10] As shown in Fig. 1, the catheter 100 includes a guidewire 10 and a torquer 30. The guidewire 10 has a predetermined length, and has a distal end 11 and a proximal end 12. Most of the guidewire 10 is covered by a cylindrical guiding catheter 13. The guidewire 10 is inserted through the guiding catheter 13. The catheter 100 is used when performing treatment on a blood vessel inside the body. The guidewire 10 is moved to a desired position in the blood vessel.

[0014] A tip portion 11 of the guidewire 10 is exposed from a guiding catheter 13. A balloon 14 is attached to a portion in the vicinity of the tip portion 11. The tip portion 11 protrudes from the balloon 14.

[0015] A Y connector 16, a balloon catheter 15, and a Y connector 17 are connected to the proximal end side of the guiding catheter 13. The guidewire 10 is inserted through the Y connector 16, the balloon catheter 15, and the Y connector 17, and then inserted into the guiding catheter 13.

[0016] An extension tube 21 and a triple cock 22 are connected to the Y connector 16. A tube for supplying saline, for example, is connected to the triple cock 22. A tube for monitoring arterial pressure is also connected to the triple cock 22. An extension tube 25 and an indeflator 26 are connected to the Y connector 17.

[0017] [Torquer 30] As shown in Figs. 2 to 4, a torquer 30 is connected to the base end 12 of the guidewire 10. The torquer 30 has through holes 55, 65 formed therein that penetrate the torquer 30 in the longitudinal direction. The guidewire 10 is inserted through the through holes 55, 65 of the torquer 30. The torquer 30 includes a center maintaining part 40, a holding part 50, and an operating part 60. The guidewire 10 is formed so that the movement of the catheter tip part follows the operation of the torquer 30. The "catheter tip part" refers to the tip part 11 of the guidewire 10.

[0018] [Operating parts 60] The operation part 60 is rod-shaped. A through hole 65 is formed in the operation part 60. The operation part 60 has a tip part 61 and a main body part 62. The outer diameter of the tip part 61 may be smaller than the outer diameter of the main body part 62. The main body part 62 is a part that is held by an operator. The operator can move the guidewire 10 in the longitudinal direction of the guidewire 10 and rotate the guidewire 10 about the axis line L1 by holding the main body part 62 and pushing or pulling it. The axis line L1 is an axis line along the longitudinal direction of the guidewire 10. The operation part 60 is an example of a cylindrical body.

[0019] [Holding parts 50] The holding part 50 is rod-shaped. A through hole 55 is formed in the holding part 50. The holding part 50 holds the guide wire 10 by inserting it through the through hole 55. The outer circumferential surface of the guide wire 10 may be in close contact with the inner circumferential surface of the through hole 55 of the holding part 50. The holding part 50 moves integrally with the guide wire 10.

[0020] The length of the holding part 50 in the axial direction is shorter than the length of the operating part 60 in the axial direction. The holding part 50 has a tip part 51 and a main body part 52. The tip part 51 is conical, and the main body part 52 is cylindrical. The main body part 52 is attached to a through hole 65 of the tip part 61 of the operating part 60. The outer peripheral surface of the main body part 52 of the holding part 50 is in close contact with the inner peripheral surface of the tip part 61 of the operating part 60. The main body part 52 of the holding part 50 may be formed in the axial direction up to a position that overlaps with the main body part 62 of the operating part 60.

[0021] The holding part 50 holds the guidewire 10 and is held by the operation part 60. The operation part 60 is connected to the guidewire 10 via the holding part 50. The operation part 60, the holding part 50, and the guidewire 10 can move as a unit.

[0022] The tip portion 51 is formed in a generally conical shape that continues from the main body portion 52 in the distal direction in the axial direction and has an apex in the distal direction. The distal direction is the side closer to the tip portion 11 in the axial direction. The outer diameter of the portion of the tip portion 51 closer to the main body portion 52 is larger than that of the main body portion 52. The outer diameter of the apex of the tip portion 51 is smaller than the outer diameter of the main body portion 52. In a cross section along the axial direction of the tip portion 51, the outer peripheral surface of the tip portion 51 is inclined with respect to the axis. The end face on the base end side of the tip portion 51 may abut against the end face of the tip portion 61 of the operating component 60 in the axial direction.

[0023] When the holding component 50 is attached to the operating component 60, the main body portion 52 is accommodated in the through hole of the operating component 60, and the tip portion 51 protrudes further toward the tip side than the operating component 60 in the axial direction.

[0024] [Center support parts 40] The center maintaining component 40 has a cylindrical shape. The center maintaining component 40 is formed so as to cover the tip portion 61 of the operation component 60 and the holding component 50. The holding component 50 and the tip portion 61 of the operation component 60 are inserted from an opening on the rear end side of the center maintaining component 40.

[0025] 3, the inner diameter of the opening on the rear end side of the center retention component 40 is larger than the inner diameter of the opening on the front end side. The front end side portion of the center retention component 40 is formed to extend further toward the front side than the front end portion 51 of the holding component 50 in the axial direction.

[0026] The center maintaining component 40 has an inner peripheral surface 41 that abuts against an outer peripheral surface 51a of the tip portion 51 of the holding component 50. In a cross section along the axial direction, the inner peripheral surface 41 is formed to be inclined with respect to the axis so that the inner diameter narrows toward the tip.

[0027] The center maintaining part 40 has an inner peripheral surface 42 that forms an opening on the tip side. In a cross section along the axial direction, the inner peripheral surface 42 is inclined with respect to the axis so that the inner diameter widens toward the tip side. The inner peripheral surface 42 may not be inclined, and may be a surface parallel to the axial direction. The inner diameter of the opening on the tip side is the same as or larger than the inner diameter of the boundary between the inner peripheral surface 41 and the inner peripheral surface 41, but may be the same. The outer peripheral surface of the guidewire 10 does not contact the inner peripheral surfaces 41, 42 of the center maintaining part 40, but may contact them. The center maintaining part 40 has a function of fixing the guidewire 10 to the holding part 50 by tightening the tip part 61 of the operation part 60 and the tip part 51 of the holding part 50 from the outside toward the inside.

[0028] [Strain detector 70] 3 to 8, the catheter 100 includes a strain detection unit 70. The strain detection unit 70 includes strain gauges 71 to 74. The strain detection unit 70 detects strain in the torquer 30 by attaching the strain gauges 71 to 74 to the torquer 30 at predetermined positions.

[0029] The strain gauges 71 to 74 are attached to the outer peripheral surface 61a of the tip portion 61 of the operation part 60 of the torquer 30, and are arranged at different positions from each other in the circumferential direction of the operation part 60. The circumferential direction of the operation part 60 is an example of the circumferential direction around the axis of the torquer 30. The circumferential direction around the axis may be the circumferential direction of a virtual circle centered on the axis.

[0030] The strain detection unit 70 has a first strain gauge that detects strain caused by rotation of the torquer 30 around the axis, and a second strain gauge that detects strain caused by movement of the torquer 30 in the axial direction. The strain gauges 71 and 72 are an example of a first strain gauge. The strain gauges 73 and 74 are an example of a second strain gauge. The strain gauges 71 to 74 are, for example, strain gauges of the same structure. The strain gauges 71 to 74 have different gauge directions. The arrangement direction of the strain gauges 71 to 74 will be described later.

[0031] The first strain gauges 71 and 72 are disposed facing each other in the radial direction of the guide wire 10. The strain gauges 71 and 72 are disposed at positions 180 degrees apart from each other in the circumferential direction of the operation component 60.

[0032] The second strain gauges 73 and 74 are disposed facing each other in the radial direction of the guide wire 10. The strain gauges 73 and 74 are disposed at positions 180 degrees apart from each other in the circumferential direction of the operation component 60. In the circumferential direction, for example, the strain gauges 71, 73, 72, and 74 are disposed in this order. These strain gauges 71, 73, 72, and 74 are disposed at positions shifted by 90 degrees each in the circumferential direction. The strain gauges 71 to 74 may be disposed at the same position in the axial direction.

[0033] As shown in Figs. 5 to 8, a protruding piece 63 is formed on the tip 61 of the operating part 60, protruding from the outer circumferential surface 61a in the radial direction. The protruding piece 63 is ring-shaped when viewed in the axial direction. The plate thickness direction of the protruding piece 63 is along the axial direction. The protruding piece 63 is formed in approximately the center of the tip 61 in the axial direction. The outer diameter of the protruding piece 63 may be the same as the outer diameter of the main body 62. Each of the strain gauges 71 to 74 is affixed to the outer circumferential surface 61a between the protruding piece 63 and the main body 62 in the axial direction.

[0034] 9 is a plan view showing a strain detecting film device which is an example of each of the strain gauges 71 to 74. The strain gauge element has a film substrate 81, a resistor 82, wiring 83, and a terminal 84. The film substrate 81 has, for example, a rectangular shape in a plan view. The film substrate 81 is formed from an insulator such as a film of polyimide or polyester.

[0035] The resistor 82 and the wiring 83 are formed of a thin film made of a conductor such as a copper-nickel alloy, chromium, or chromium nitride. The resistor 82 and the wiring 83 are made of the same material and are deposited on a film substrate 81. The resistor 82 includes a plurality of strip-shaped portions. The plurality of strip-shaped portions extend, for example, in a direction intersecting the gauge direction G1. The plurality of strip-shaped portions are arranged at predetermined intervals in the gauge direction G1. The plurality of strip-shaped portions are connected in the gauge direction G1.

[0036] The pair of terminals 84 are connected to the wiring 83. The pair of terminals 84 are formed at ends of the pair of wirings 83 that are farther from the resistor 82. The pair of terminals 84 are formed as a film on the pair of wirings 83. The terminals 84 are formed from a conductive material.

[0037] As shown in FIG. 3, a wire 75 is electrically connected to each of the strain gauges 71 to 74. The wire 75 is electrically connected to a terminal 84 shown in FIG. 9. The wire 75 is introduced from the outer peripheral surface of the operation component 60 into the inside of a through hole. The wire 75 is disposed inside the through hole inside the operation component 60 and is led out from an opening at the rear end. The wire 75 is connected to an AFE 211, which will be described later. Note that the path of the wire 75 is not limited to the through hole, and for example, the wire 75 may be laid on the surface of the main body 62, or a groove may be provided on the surface of the main body 62 and the wire 75 may be disposed in the groove.

[0038] 5, the gauge direction G1 of the strain gauge 71 is disposed so as to intersect with the axis L1 when viewed in the radial direction of the guide wire 10. The gauge direction G1 of the strain gauge 71 is inclined at 45 degrees with respect to the axis L1.

[0039] 7, the gauge direction G1 of the strain gauge 72 is disposed so as to intersect with the axis L1 when viewed in the radial direction of the guide wire 10. The gauge direction G1 of the strain gauge 72 is inclined at 45 degrees with respect to the axis L1 and intersects with the gauge direction G1 of the strain gauge 71 at 90 degrees. The gauge direction G1 of the strain gauge 72 is inclined in the opposite direction to the gauge direction G1 of the strain gauge 71 with respect to the axis L1.

[0040] As shown in FIG. 6, the gauge direction G1 of the strain gauge 73 is arranged in the same direction as the axis L1 when viewed in the radial direction of the guide wire .

[0041] 8, the gauge direction G1 of the strain gauge 74 is disposed so as to be perpendicular to the axis L1 when viewed in the radial direction of the guide wire 10. The gauge direction G1 of the strain gauge 74 is perpendicular to the gauge direction G1 of the strain gauge 73.

[0042] [Catheter system 200] Next, a catheter system 200 including the catheter 100 will be described. Fig. 10 is a block diagram showing a hardware configuration of the catheter system 200. The catheter system 200 includes the catheter 100 and a control device 210. The control device 210 is an example of a control unit. The control device 210 includes an AFE 211 and a microcomputer 212.

[0043] [AFE211] The AFE 211 converts an analog signal, which is a detection signal output from the strain detection unit 70, into a digital signal by an A / D conversion circuit. The AFE 211 can amplify the analog signal. The AFE 211 can perform linearity correction on the digital signal.

[0044] [Microcomputer 212] The microcomputer (MCU) 212 is a small computer for controlling electronic devices, and operates according to input signals. The microcomputer 212 has a CPU (Center Processing Unit) 213 and a storage unit 214. The storage unit 214 includes a ROM (Read Only Memory) 215 and a RAM (Random Access Memory) 216. The ROM 215 stores various programs for causing the CPU 213 to execute control processing, as well as various data necessary for the operation of the catheter 100. The RAM 216 temporarily stores data acquired from the strain detection unit 70. The AFE 211 is connected to the microcomputer 212.

[0045] [Alarm 217] The control device 210 has an alarm 217. The alarm 217 is connected to the microcomputer 212. The alarm 217 outputs an alarm sound in accordance with a command signal output from the CPU 213. The alarm 217 can output a plurality of types of alarm sounds, as will be described later.

[0046] [LDO218] The control device 210 is equipped with an LDO (Low Drop Out) 218. The LDO 218 is a linear regulator that can operate even when the input / output voltage difference is small. The LDO 218 is a type of power supply IC, and can output a constant voltage lower than the input voltage. By including the LDO 218, the control device 210 can operate even when the voltage difference between the input voltage and the output voltage is small. This allows the control device 210 to suppress heat generation and to effectively utilize energy.

[0047] [USB-serial conversion IC221] The control device 210 is equipped with a USB-serial conversion IC 221. The USB-serial conversion IC 221 is connected to the microcomputer 212. In addition, the USB-serial conversion IC 221 is connected to a PC 230 via a USB.

[0048] [Reset IC222] The control device 210 is equipped with a reset IC 222. The reset IC 222 is connected to the microcomputer 212. The reset IC is also called a "voltage detector" or a "power supply monitoring IC." The reset IC 222 can monitor the power supply voltage of the electronic device. The reset IC 222 can detect when the voltage falls below a threshold. The reset IC 222 may detect when the voltage reaches a certain value or higher. The reset IC can detect when the output voltage of the power supply IC reaches or exceeds the operating voltage of the microcomputer 212. The reset IC 222 can start up the microcomputer 212 by canceling a reset signal to the microcomputer 212.

[0049] [XTAL223] XTAL223 is a quartz crystal unit. XTAL223 is a type of passive element that can generate oscillations with high frequency accuracy by utilizing the piezoelectric effect of quartz.

[0050] [PC230] The catheter system 200 includes a PC 230. The PC 230 is connected to the control device 210. The PC 230 has a CPU and a memory unit. The memory unit includes a ROM and a RAM. A display unit 231 is connected to the PC 230. The display unit 231 may be, for example, a liquid crystal display device. The display unit 231 may be a touch panel that allows touch input. The display unit 231 may function as an input unit.

[0051] [Functional configuration of catheter system 200] The CPU of the PC 230 can execute various functions by executing programs stored in the storage unit. Fig. 11 is a functional block diagram of the catheter system 200. As shown in Fig. 11, the catheter system 200 includes strain amount analyzers 241 and 242, a determination unit 243, a notification control unit 244, and a storage unit 251.

[0052] The strain amount analysis unit 241 analyzes the amount of strain caused by the rotation of the torquer 30 about the axis based on the detection results by the strain gauges 71 and 72.

[0053] The strain amount analysis unit 242 analyzes the amount of strain caused by the movement of the torquer 30 in the axial direction based on the detection results by the strain gauges 73 and 74. The strain amount analysis unit 242 analyzes the amount of strain caused by the pushing and pulling of the torquer 30.

[0054] The determination unit 243 determines the behavior of the tip portion 11 of the guidewire 10 of the catheter 100 based on the analysis results by the strain amount analysis units 241, 242. The determination unit 243 may determine the magnitude of acceleration of the tip portion 11. The determination unit 243 can determine abrupt operation of the tip portion 11. The determination unit 243 may determine whether or not an excessive load acts on the tip portion 11. The determination unit 243 may determine whether or not the amount of strain acting on the torquer 30 exceeds a determination threshold, and determine that an excessive load acts on the tip portion 11 when the amount of strain exceeds the determination threshold.

[0055] The notification control unit 244 controls the contents to be displayed on the display unit 231. The notification control unit 244 can display the torque acting on the tip portion 11 and the force in the pushing and pulling directions on the display unit 231. The notification control unit 244 may change the display mode on the display unit 231 according to the magnitude of the torque and force acting on the tip portion 11.

[0056] The notification control unit 244 controls the contents of notification using an alarm sound. The notification control unit 244 can notify the torque acting on the tip portion 11 and the force in the pushing and pulling directions using an alarm sound. The notification control unit 244 can output an alarm sound from the alarm 217 by controlling the operation of the alarm 217 which is an audio output unit. The audio output unit is not limited to the alarm 217, and may be a speaker.

[0057] The storage unit 251 stores various programs. The storage unit 251 can temporarily store data acquired from the strain detection unit 70. The storage unit 251 includes an image information storage unit that stores image information displayed on the display unit 231.

[0058] [Operation of Microcomputer 212] The microcomputer 212 can transmit, for example, an AFE control command to the AFE 211. The microcomputer 212 can receive A / D converted data from the AFE 211. The microcomputer 212 can input an A / D conversion completion signal. The microcomputer 212 can detect a rising edge or a falling edge included in the A / D conversion completion signal.

[0059] [PC230 Operation] The PC 230 transmits an AFE control command to the microcomputer 212. The PC 230 receives the A / D converted data. The PC 230 can transmit an alarm command to the microcomputer 212. By transmitting the alarm command, the PC 230 can cause the alarm 217 to output an alarm sound.

[0060] [Operation of catheter system 200] The AFE 211 receives two types of analog signals from the catheter 100. The two types of analog signals include an analog signal related to rotation and an analog signal related to pushing and pulling. The strain gauges 71 and 72 output analog signals related to rotation.

[0061] The AFE 211 amplifies an analog signal. The AFE 211 converts the analog signal into a digital signal. The AFE 211 performs linearity correction on the digital signal as necessary. The AFE 211 is controlled by a general-purpose microcomputer 212. The AFE 211 is connected via a synchronous communication interface such as an Inter-Integrated Circuit (I2C) or a Serial Peripheral Interface (SPI).

[0062] The AFE 211 outputs an A / D conversion completion notification signal, and the A / D conversion completion notification signal is input to the microcomputer 212. The microcomputer 212 is connected between the AFE 211 and the PC 230.

[0063] The microcomputer 212 transmits a setting command for the AFE 211 to the AFE 211 using I2C communication. The microcomputer 212 receives the setting command for the AFE 211 from the PC 230 using UART (Universal Asynchronous Receiver Transmitter) communication. "UART" is one type of asynchronous serial communication, and is a method of communicating data according to predetermined start and end signals.

[0064] The microcomputer 212 receives the A / D converted value from the AFE 211 through I2C communication. The microcomputer 212 temporarily holds the A / D converted value. The microcomputer 212 transmits the A / D converted value to the PC 230 through UART communication.

[0065] The PC 230 performs catheter behavior measurement and operation assistance.

[0066] In the catheter system 200, an alarm sound is output from the alarm 217 as an operation assistance. The alarm 217 can output, for example, three types of alarm sounds. The PC 230 outputs a command to the microcomputer 212, and the microcomputer 212 causes the alarm 217 to output an alarm sound in accordance with this command. The three types of alarm sounds can notify, for example, "normal," "caution," and "danger."

[0067] [Display Image] Next, a display image 300 in the catheter system 200 will be described. Fig. 12 is a diagram showing an example of the display image 300 in the catheter system 200. The display unit 231 can display the display image 300. The notification control unit 244 functions as a display control unit that causes the display unit 231 to display the display image 300.

[0068] [Buttons 311-314] The display image 300 includes a display area for displaying various kinds of image information. The display image 300 includes a display area for displaying buttons 311 to 314. The button 311 includes text information "COM CONNECT" and a frame surrounding the text information. By operating the button 311, the user can instruct the catheter system 200 to establish a serial communication connection. The PC 230 establishes serial communication with the microcomputer 212.

[0069] The button 312 includes text information "AFE INIT" and a frame surrounding the text information. The user can instruct initialization of the AFE 211 by operating the button 312. The PC 230 transmits a setting command for the AFE 211 to the microcomputer 212 via UART communication. The microcomputer 212 initializes the AFE 211 in response to the setting command.

[0070] Button 313 includes the text information "START" and a frame surrounding the text information. By operating button 313, the user can instruct catheter system 200 to start measurement. PC 230 transmits a command to start A / D conversion in AFE 211 to microcomputer 212. Microcomputer 212 starts A / D conversion in response to the A / D conversion start command. This causes catheter system 200 to start measurement by strain detection unit 70.

[0071] Button 314 includes the text information "STOP" and a frame surrounding the text information. By operating button 314, the user can instruct catheter system 200 to end measurement. PC 230 transmits a command to end A / D conversion in AFE 211 to microcomputer 212. Microcomputer 212 ends A / D conversion in response to the A / D conversion end command. This causes catheter system 200 to end measurement by strain detection unit 70.

[0072] Display image 300 may also include a display area for displaying buttons for performing other operations.

[0073] [Value display section 321] The display image 300 includes a display area that displays a value display section 321. The value display section 321 includes text information that displays the torque value, and a frame that surrounds the text information. The value display section 321 can display text information such as "Rotation: 0.0 cm N". The display control section may change the color of the inside of the frame of the value display section 321 depending on the torque value.

[0074] [Value display section 322] Display image 300 includes a display area that displays value display section 322. Value display section 322 includes text information that displays the value of the pushing / pulling force, and a frame that surrounds the text information. Value display section 322 can display text information such as "Push / Pull: 0.0 N." The display control section may change the color of the inside of the frame of value display section 322 depending on the value of the pushing / pulling force (load).

[0075] [Display area 331] The display image 300 includes a display area 331. The display area 331 may be a circular display area. The color of the display area 331 changes depending on the detection result by the strain gauges 71 and 72.

[0076] [Display area 332] The display image 300 includes a display area 332. The display area 332 may be a circular display area. The color of the display area 332 changes depending on the detection result by the strain gauges 73, 74. The display area 332 is arranged inside the display area 331. The display area 331 may be a circle larger than the display area 332. The value display unit 322 is arranged in the center of the display area 332. The value display unit 321 is arranged outside the display area 331. The display area 331 may be arranged above the display area 331 in the display unit 231.

[0077] [Mark 341, 342] The display image 300 includes a display area that displays marks 341 and 342. The marks 341 and 342 may be figures forming a triangle, for example. The marks 341 and 342 may be figures of, for example, an arrow, a diamond, or other shapes. The mark 341 indicates, for example, a reference torque value. The mark 341 is disposed, for example, outside the circumference of the display area 331. The mark 341 is disposed directly above the display area 331 on the display unit 231. One of the vertices of the mark 341 is disposed facing downward. The position of one of the vertices of the mark 341 indicates a reference position. This reference position indicates that the torque value is 0.

[0078] Mark 342 indicates the torque value detected by strain gauges 71, 72. Mark 342 changes along the circumference of display area 331. Mark 342 is arranged inside the circumference of display area 331. The position of mark 342 indicates the magnitude of the torque value and the direction of the torque. When one of the vertices of mark 342 is at the same position as one of the vertices of mark 341 indicating the reference, it indicates that the torque value is 0 cm·N. When mark 342 is displayed to the right of mark 431, it indicates that the direction of the torque is clockwise. When mark 342 is displayed to the left of mark 431, it indicates that the direction of the torque is counterclockwise. When the rotation angle position of mark 342 is large, it indicates that the torque value is large compared to when the rotation angle position is small.

[0079] Fig. 13 is a diagram showing an example of a display image 300 in the catheter system 200. A mark 342 moves along the circumference of a circular display area 331. Although a plurality of marks 342 are shown in Fig. 13, only one mark 342 is displayed on the display unit 231. The mark 342 indicates the current torque value and the direction of the torque.

[0080] Marks 342A to 342G indicate marks 342 displayed at different positions. Mark 342A is located above display area 331 on display unit 231. The position where mark 342A is displayed is set to 0 degrees. The positions of marks 342 (342A to 342G) are indicated by rotation angles θ (θ1 to θ6) around center C of circular display area 331. When the torque value is 0 cm N, mark 342A is located at the 0 degree position.

[0081] When the torque direction is clockwise, the rotation angle θ is set to a value greater than 0 degrees. When the torque direction is counterclockwise, the rotation angle θ is set to a value smaller than 0 degrees. The rotation angle θ1 of mark 342B may be 45 degrees. The rotation angle θ2 of mark 342C may be -45 degrees. The rotation angle θ3 of mark 342D may be 90 degrees. The rotation angle θ2 of mark 342E may be -90 degrees. The rotation angle θ5 of mark 342F may be 135 degrees. The rotation angle θ6 of mark 342G may be -135 degrees. When the torque value is large, the absolute value of the rotation angle θ is larger than when the torque value is small.

[0082] [If the torque value is normal] When the torque value is normal, the notification control unit 244 displays the marks 342A, 342B, 342C within the range of the rotation angle θ (θ1, θ2) between -45 degrees and 45 degrees. When the torque value is normal, the notification control unit 244 may make the color of the display area 331 blue. The color of the display area 331 is not limited to blue, and may be, for example, green or another color. When the torque value is normal, the notification control unit 244 causes the alarm 217 to output an alarm sound once per second. The range in which the torque value is normal may be set arbitrarily by the user.

[0083] [If the torque value is abnormal] When the torque value is abnormal, the notification control unit 244 displays marks 342D, 342E when the rotation angle θ is within a range of more than 45 degrees and less than 90 degrees, or within a range of -90 degrees or more and less than -45 degrees. When the torque value is abnormal, the notification control unit 244 may change the color of the display area 331 to yellow. The color of the display area 331 is not limited to yellow and may be another color. When the torque value is abnormal, the notification control unit 244 causes the alarm 217 to output an alarm sound twice per second. The range in which the torque value is abnormal may be set arbitrarily by the user.

[0084] The number of times the alarm sounds when the torque value is abnormal is greater than the number of times the alarm sounds when the torque value is normal, and the absolute value of the torque value when the torque value is abnormal is greater than the absolute value of the torque value when the torque value is normal.

[0085] [When torque values ​​are dangerous] When the torque value is dangerous, the notification control unit 244 displays marks 342F, 342G when the rotation angle θ is in a range of more than 90 degrees and less than 180 degrees, or in a range of more than -180 degrees and less than -90 degrees. When the torque value is dangerous, the notification control unit 244 may change the color of the display area 331 to red. The color of the display area 331 is not limited to red and may be another color. When the torque value is dangerous, the notification control unit 244 causes the alarm 217 to output an alarm sound three times per second. The range in which the torque value is dangerous may be set arbitrarily by the user.

[0086] The number of times the alarm sounds when the torque value is dangerous is greater than the number of times the alarm sounds when the torque value is abnormal. The absolute value of the torque value when the torque value is dangerous is greater than the absolute value of the torque value when the torque value is abnormal.

[0087] [When the push and pull force values ​​are normal] When the pushing / pulling force value is normal, the notification control unit 244 may make the color of the display area 332 blue. The color of the display area 332 is not limited to blue, and may be, for example, green or another color. When the pushing / pulling force value is normal, the notification control unit 244 causes the alarm 217 to output an alarm sound once per second. The range in which the pushing / pulling force value is normal may be arbitrarily set by the user.

[0088] [If the push / pull force value is abnormal] When the pushing / pulling force value is abnormal, the notification control unit 244 may change the color of the display area 332 to yellow. The color of the display area 332 is not limited to yellow and may be another color. When the pushing / pulling force value is abnormal, the notification control unit 244 causes the alarm 217 to output an alarm sound twice per second. The range in which the pushing / pulling force value is abnormal may be arbitrarily set by the user.

[0089] The number of times an alarm sounds when the pushing / pulling force value is abnormal is greater than the number of times an alarm sounds when the pushing / pulling force value is normal. The absolute value of the pushing / pulling force value when the pushing / pulling force value is abnormal is greater than the absolute value of the pushing / pulling force value when the pushing / pulling force value is normal.

[0090] [When the push / pull force value is dangerous] When the pushing / pulling force value is dangerous, the notification control unit 244 may change the color of the display area 332 to red. The color of the display area 332 is not limited to red and may be another color. When the pushing / pulling force value is dangerous, the notification control unit 244 causes the alarm 217 to output an alarm sound three times per second. The range in which the pushing / pulling force value is dangerous may be arbitrarily set by the user.

[0091] The number of alarm sounds when the pushing / pulling force value is dangerous is greater than the number of alarm sounds when the pushing / pulling force value is abnormal. The absolute value of the pushing / pulling force value when the pushing / pulling force value is dangerous is greater than the absolute value of the pushing / pulling force value when the pushing / pulling force value is abnormal.

[0092] [Control Processing in Catheter System 200] Fig. 14 is a flowchart showing an example of a control processing procedure (part 1) in the catheter system 200. Fig. 15 is a flowchart showing an example of a control processing procedure (part 2) in the catheter system 200. The processing shown in Fig. 14 is executed by the CPU of the PC 230.

[0093] 14, the CPU of the PC 230 transmits a setting command to the microcomputer 212 to establish serial communication (step S11). Serial communication between the PC 230 and the microcomputer 212 is established.

[0094] The CPU of the PC 230 initializes the warning meter, that is, returns the color of the warning meter to normal for both rotation and pushing and pulling (step S12). The "warning meter" includes initializing a function for displaying the display image 300 shown in Fig. 12 and Fig. 13 on the display unit 231, for example.

[0095] The CPU of the PC 230 transmits an AFE initialization command to the microcomputer 212 (step S13). The microcomputer 212 initializes the AFE 211 in response to the AFE initialization command.

[0096] The CPU of the PC 230 transmits a measurement start command to the microcomputer 212 (step S14). In response to the measurement start command, the microcomputer 212 causes the strain detector 70 to start measurement.

[0097] In the catheter system 200, after executing the process shown in Fig. 14, the process shown in Fig. 15 is executed. The CPU of the PC 230 receives the A / D converted data (step S21). The CPU of the PC 230 receives the data A / D converted by the AFE 211 from the microcomputer 212.

[0098] The CPU of PC 230 converts the received A / D converted data into an output voltage value (step S22). The CPU of PC 230 converts the converted output voltage value into a load (step S23). The CPU of PC 230 converts the output voltage value based on the detection results by strain gauges 71, 72 into a load that is a torque value. The CPU of PC 230 converts the output voltage value based on the detection results by strain gauges 73, 74 into a load that is a pushing / pulling force value.

[0099] The CPU of the PC 230 executes the load evaluation (part 1) (step S24). The CPU of the PC 230 judges whether the load is equal to or less than the first judgment threshold Th1. As described above, the "load" is the "torque value" based on the detection results by the strain gauges 71 and 72, and the "push / pull force value" based on the detection results by the strain gauges 73 and 74. Here, the case where the "load" is the torque value will be described. Note that the CPU of the PC 230 also executes the case where the "load" is the push / pull force value. In addition, the judgment of whether the load is equal to or less than the first judgment threshold Th1 is made by comparing the magnitude of the absolute value. The first judgment threshold Th1 is a value for judging whether the load (torque value) is within a range of values ​​that are "normal".

[0100] If the CPU of the PC 230 determines that the load is equal to or less than the first determination threshold Th1 (step S24; YES), the CPU of the PC 230 executes the process of step S26. If the CPU of the PC 230 determines that the load is not equal to or less than the first determination threshold Th1 (step S24; NO), the CPU of the PC 230 executes the process of step S25.

[0101] In step S25, the CPU of the PC 230 executes load evaluation (part 2) (step S25). The CPU of the PC 230 judges whether the load is equal to or less than the second judgment threshold Th2. The absolute value of the "second judgment threshold Th2" is a value greater than the absolute value of the "first judgment threshold Th1". The second judgment threshold Th2 is a value for judging whether the load (torque value) is within a range of values ​​that are "abnormal". In the load evaluation in step S25, if the load is not "abnormal", it is judged to be "dangerous".

[0102] If the CPU of the PC 230 determines that the load is equal to or less than the second determination threshold Th2 (step S25; YES), the CPU of the PC 230 executes the process of step S27. If the CPU of the PC 230 determines that the load is not equal to or less than the second determination threshold Th2 (step S25; NO), the CPU of the PC 230 executes the process of step S28.

[0103] In step S26, the CPU of the PC 230 determines that the torque value is normal. The CPU of the PC 230 changes the color of the display area 331 to blue and displays it on the display unit 231. The CPU of the PC 230 sets an alarm sound change command so that the alarm sound is set to once per second.

[0104] In step S27, the CPU of the PC 230 determines that the torque value requires caution. The CPU of the PC 230 causes the color of the display area 331 to be yellow and displays it on the display unit 231. The CPU of the PC 230 sets an alarm sound change command so that the alarm sound is set to two times per second.

[0105] In step S28, the CPU of the PC 230 determines that the torque value is dangerous. The CPU of the PC 230 changes the color of the display area 331 to red and displays it on the display unit 231. The CPU of the PC 230 sets an alarm sound change command so that the alarm sound is set to three times per second.

[0106] In step S29, the CPU of the PC 230 transmits the alarm sound change command set in any one of steps S26 to S28 to the microcomputer 212. The microcomputer 212 causes the alarm 217 to output an alarm sound in response to the alarm sound change command.

[0107] The CPU of the PC 230 also processes the load, which is the value of the pushing and pulling force, in the same manner as the torque value.

[0108] [Correlation between load on catheter 100 and output of strain detection unit 70] Fig. 16(a) is a graph showing the relationship between the load and the absolute value of the output voltage. In Fig. 16(a), the horizontal axis shows the load (N) and the vertical axis shows the absolute value (mV / V) of the output voltage detected by the strain gauges 73, 74. In both the pushing and pulling cases, there was a correlation between the actual load and the absolute value of the output voltage.

[0109] Figure 16(b) is a graph showing the relationship between torque and the absolute value of the output voltage. In Figure 16(b), the horizontal axis shows torque (cN m), and the vertical axis shows the absolute value of the output voltage (mV / V) detected by strain gauges 71 and 72. There was a correlation between the actual torque and the absolute value of the output voltage in both clockwise and counterclockwise rotation.

[0110] [Effects of catheter 100] The catheter 100 of this embodiment comprises a guidewire 10, a cylindrical body through which the base end 12 of the guidewire 10 is inserted, a torquer 30 that holds the guidewire 10 within the cylindrical body and extends outside the cylindrical body on the side opposite the tip end 11 of the guidewire 10 and controls the movement of the guidewire 10 to a desired position together with the guidewire 10, and a strain detection unit 70 that is provided on the torquer 30 and detects strain in the torquer 30 that occurs when the guidewire 10 is operated and generates an analog signal corresponding to the strain.

[0111] According to the catheter 100 having this configuration, the catheter 100 is equipped with the strain detection unit 70, has a simple configuration, and is capable of detecting the strain of the torquer 30.

[0112] In the catheter 100, the strain detection unit 70 is attached to the outer peripheral surface 61a of the tip portion 61 of the torquer 30. According to the catheter 100 having this configuration, the strain of the torquer 30 can be detected with high accuracy by the strain detection unit 70 attached to the tip portion 61 of the torquer 30.

[0113] In the catheter 100, the torquer 30 is disposed within a cylindrical body and comprises a cylindrical holding part 50 which holds the guidewire 10, an operating part 60 which has a cavity extending in the longitudinal direction of the guidewire 10 and holds the holding part 50 within the cavity while allowing the guidewire 10 to be passed therethrough, and a cylindrical center maintaining part 40 which covers the holding part 50 and part of the operating part 60, and the strain detection unit 70 is affixed to the outer peripheral surface 61a of the operating part 60, and the center maintaining part 40 is disposed so as to cover the strain detection unit 70.

[0114] The catheter 100 of this embodiment comprises a guidewire 10, a cylindrical body through which the base end 12 of the guidewire 10 is inserted, a torquer 30 having a predetermined length in the longitudinal direction of the guidewire 10, holding the guidewire 10 within the cylindrical body, extending outside the cylindrical body on the side opposite the tip end of the guidewire 10 and movable together with the guidewire 10, strain gauges (first strain gauges) 71, 72 provided on the torquer 30 and detecting strain associated with rotation of the torquer 30 around an axis along the longitudinal direction of the guidewire 10, and strain gauges (second strain gauges) 73, 74 provided on the torquer 30 and detecting strain associated with movement of the torquer 30 along the longitudinal direction of the guidewire 10.

[0115] According to the catheter 100 having this configuration, the strain caused by the rotation of the torquer 30 can be detected based on the detection results by the strain gauges 71, 72, and the strain caused by the pushing and pulling of the torquer 30 can be detected based on the detection results by the strain gauges 73, 74.

[0116] The catheter 100 is provided with a plurality of first strain gauges 71, 72 arranged opposite each other in the radial direction of the guidewire 10, and the gauge directions G1 of the plurality of first strain gauges 73, 74 are arranged so as to intersect both a first direction along the longitudinal direction of the guidewire 10 and a second direction perpendicular to the first direction, when viewed in the radial direction of the guidewire 10, and are also arranged so as to be perpendicular to each other.

[0117] In the catheter 100, the second strain gauges 73, 74 are disposed between the multiple first strain gauges 71, 72 in the circumferential direction about the axis L1 along the longitudinal direction of the guidewire .

[0118] The catheter 100 is provided with a plurality of second strain gauges 73, 74 arranged opposite each other in the radial direction of the guidewire 10, and the gauge directions G1 of the plurality of second strain gauges 73, 74 are respectively arranged along a first direction along the longitudinal direction of the guidewire 10 and a second direction perpendicular to the first direction, when viewed in the radial direction of the guidewire 10.

[0119] According to the catheter 100 having such a configuration, the strain gauges 73 and 74 are arranged so as to be perpendicular to each other when viewed in the radial direction of the guidewire 10, so that it is possible to eliminate the influence of elongation caused by the temperature of the torquer 30. Therefore, it is possible to improve the detection accuracy.

[0120] The catheter 100 includes an AFE (analog-to-digital converter) 211 electrically connected to the strain detection unit 70, and the AFE 211 converts an analog signal, which is a detection signal output from the strain detection unit 70, into a digital signal.

[0121] In the catheter 100, the strain detection unit 70 is formed by forming an element on a film substrate made of polyimide, polyester, or the like using a conductive metal film containing, for example, a copper-nickel alloy, chromium, chromium nitride, or the like, and when chromium or chromium nitride, for example, is used, it has a high sensitivity of a gauge factor of 10 to 20.

[0122] In the catheter 100, the strain gauges (strain detection film devices) 71 to 74 are mounted on the operating part (torquer) via an adhesive. The adhesive is selected with an emphasis on material compatibility, strain transmission, and environmental characteristics.

[0123] The strain detector 70 is provided at a location capable of detecting strain of an operating part to which a load caused by the operation of the guide wire 10 is transmitted as strain via a clamper.

[0124] In the catheter 100, the strain gauges 71 to 74 are arranged facing each other. The number of strain gauges installed in the catheter 100 depends on the detection resolution. Although the catheter 100 includes a plurality of strain gauges, the catheter 100 may include only one strain gauge.

[0125] In catheter 100, the strain sensing portion of each of strain gauges 71-74 is arranged in accordance with the desired detection direction of strain. In catheter 100, each of strain gauges 71-74 is arranged in a direction corresponding to the strain component to be detected, so that the load on guidewire 10 can be measured by each of strain gauges 71-74 arranged on the operation part.

[0126] In catheter 100, a second strain gauge that detects strain associated with axial movement is disposed on the operating component while aligned with the insertion direction of guidewire 10, so that strain associated with pushing and pulling guidewire 10 can be measured.

[0127] In the catheter 100, the distortion caused by rotation of the guidewire 10 can be measured by aligning the sensing part with the desired angle (e.g., 45 degrees) relative to the insertion direction of the guidewire 10 to detect distortion caused by rotation and positioning a first strain gauge that detects distortion caused by rotation.

[0128] In the catheter 100, a pair of strain gauges 73, 74 rotated 90° from the detection direction are combined as a Wheatstone bridge circuit, which allows the catheter 100 to have a temperature compensation function.

[0129] The catheter 100 can measure the force (torque) applied to rotate the tip of the guidewire 10, and the force (load) applied to the tip of the guidewire 10 when it is pushed or pulled. The catheter 100 can quantify the behavior of the tip of the guidewire 10.

[0130] The operating parts are disposable products and may be low-cost products. By employing strain gauge elements (strain gauges 71 to 74) in catheter 100, a sensing system with a relatively low cost and simple circuit configuration can be provided.

[0131] [Effects of the catheter system 200] The catheter system 200 of this embodiment comprises a guidewire 10, a rod-shaped torquer 30 connected to the guidewire 10 and held by the operator when manipulating the guidewire 10, a strain detection unit 70 provided on the torquer 30 and detecting strain in the torquer 30, an alarm unit (display unit 231, alarm 217) that notifies the detection result by the strain detection unit 70, and a control unit (PC 230) that controls the operation of the alarm unit, and the control unit determines whether the detection result by the strain detection unit 70 exceeds a judgment threshold, and if the detection result exceeds the judgment threshold, causes the alarm unit to notify the result in an emphasized manner compared to a case where the detection result does not exceed the judgment threshold.

[0132] According to such a catheter system 200, the manner of notification can be changed according to the detection result by the strain detection unit 70. In the catheter system 200, the degree of danger is determined based on the detection result by the strain detection unit 70, and when the degree of danger is high, an alarm can be output with emphasis.

[0133] In the catheter system 200, the strain detection unit 70 has first strain gauges 71, 72 that detect strain associated with rotation of the torquer 30 around an axis along the longitudinal direction of the guidewire 10, the notification unit has a display unit 231 that displays the detection results, and the control unit causes the display unit 231 to display information according to the direction and magnitude of the torque, which is the detection result by the first strain gauges 71, 72.

[0134] According to such a catheter system 200, the operator can recognize the direction and magnitude of the torque by looking at the display unit 231. The operator can operate the catheter 100 while recognizing the direction and magnitude of the torque.

[0135] In the catheter system 200, the strain detection unit 70 has second strain gauges 73, 74 that detect strain associated with movement of the torquer 30 along the longitudinal direction of the guidewire 10, and the display unit 231 includes a first display area 331 that changes color depending on the magnitude of the detection result by the first strain gauges 71, 72, and a second display area 332 that changes color depending on the magnitude of the detection result by the second strain gauges 73, 74.

[0136] In such a catheter system 200, by changing the color of the display areas 331, 332 according to the detection result by the strain detection unit 70, it is possible to make the operator easily recognize the degree of danger.

[0137] In the catheter system 200, the notification unit has an audio output unit (alarm 217) that outputs sound according to the detection result, and the control unit determines whether or not the detection result by the strain detection unit 70 exceeds the judgment threshold, and when the detection result exceeds the judgment threshold, causes the audio output unit to output the sound with emphasis compared to when the detection result does not exceed the judgment threshold. The "emphasis" here may mean, for example, increasing the number of times the alarm sound is sounded per unit time, or increasing the volume of the alarm sound.

[0138] In the catheter system 200, when the detection result (amount of strain) by the strain detection unit 70 is large, the control unit can output an emphasized sound by increasing the number of times the warning sound (alarm sound) is output per unit time compared to when the detection result is small.

[0139] According to such a catheter system 200, the number of times an alarm sound is emitted per unit time is increased in accordance with the detection result by the strain detection section 70, thereby making it easier for the operator to recognize the degree of danger.

[0140] The catheter system 200 of this embodiment comprises a guidewire 10, a rod-shaped torquer 30 connected to the guidewire 10 and held by an operator when manipulating the guidewire 10, a strain detection unit 7070 provided on the torquer 30 and detecting strain in the torquer 30, an analog-to-digital converter (AFE211) that converts an analog signal, which is the detection signal output from the strain detection unit 70, into a digital signal, a processing unit (PC230) that measures the behavior of the guidewire 10 by processing the digital signal, and an output unit (display unit 231) that outputs information regarding the behavior of the guidewire 10.

[0141] Such a catheter system 200 can measure and output the behavior of the catheter 100. This allows the operator to understand the behavior of the catheter 100. The catheter system 200 can reduce the burden on the operator.

[0142] A doctor who is the user of the catheter system 200 operates the catheter 100 while viewing an X-ray image of the patient. In the catheter system 200, if there is any danger in operating the catheter 100, an alarm sound can be output using the alarm 217. By hearing the alarm sound, the user of the catheter system 200 can recognize that operating the catheter 100 is in a dangerous state.

[0143] The catheter system 200 may include an AFE 211 configured as one semiconductor chip. The AFE 211 can perform functions of A / D conversion, filtering, and linearity correction. Since the AFE 211 is configured as one semiconductor chip in the catheter system 200, the electrical circuit scale of the catheter system 200 can be reduced. With such a catheter system 200, a low-cost system can be constructed.

[0144] In the catheter system 200, the AFE 211 outputs an A / D conversion completion notification signal, and the microcomputer 212 inputs this A / D conversion completion notification signal. In such a catheter system 200, A / D conversion data can be acquired efficiently.

[0145] In the catheter system 200, a general-purpose microcomputer can be used as the microcomputer 212. In the catheter system 200, a general-purpose microcomputer that is inexpensive and easily available can be used. According to such a catheter system 200, it is possible to reduce development costs.

[0146] In the catheter system 200, the analog signal of the strain detector can be converted into a digital signal using an analog-to-digital converter of the ΔΣ type, successive approximation type, cyclic type, or the like.

[0147] [Bridge circuits 120A and 120B according to the first embodiment] Next, the bridge circuits 120A and 120B according to the first embodiment will be described. Fig. 17 is a diagram showing an example of the bridge circuits 120A and 120B. The bridge circuit 120A is an example of a first bridge circuit, and the bridge circuit 120B is an example of a second Wheatstone bridge circuit.

[0148] [Bridge circuit 120A] The bridge circuit 120A is a Wheatstone bridge circuit. The bridge circuit 120A includes resistors R1 to R4. The resistors 82 of the strain gauges 71 and 72 constitute one of the resistors R1 to R4 of the bridge circuit 120A. All of the resistors R1 to R4 of the bridge circuit 120A are constituted by the strain gauge 71 or the strain gauge 72. The bridge circuit 120A according to the first embodiment is an example of the case where "the resistors of the first strain gauge are connected to constitute the entire first bridge circuit."

[0149] Resistor R1 of bridge circuit 120A may be resistor 82 of strain gauge 71. Resistor R2 of bridge circuit 120A may be resistor 82 of strain gauge 72. Resistor R3 of bridge circuit 120A may be resistor 82 of strain gauge 71. Resistor R4 of bridge circuit 120A may be resistor 82 of strain gauge 72.

[0150] [Bridge circuit 120B] The bridge circuit 120B is a Wheatstone bridge circuit. The bridge circuit 120B includes resistors R1 to R4. The resistors 82 of the strain gauges 73 and 74 form one of the resistors R1 to R4 of the bridge circuit 120B. All of the resistors R1 to R4 of the bridge circuit 120B are formed by the strain gauge 73 or the strain gauge 74. The bridge circuit 120B according to the second embodiment is an example of the case where "the resistors of the second strain gauge are connected to form the entire second Wheatstone bridge circuit."

[0151] The strain detector can detect the amount of strain as an output voltage e0. The strain detector includes a bridge circuit 120A and a bridge circuit 120B.

[0152] The catheter 100 may include resistors R1 to R4 of a bridge circuit 120A and resistors R1 to R4 of a bridge circuit 120B. The resistors R1 to R4 of the bridge circuits 120A and 120B have the relationships (1) and (2) described below. This allows the catheter 100 to cancel output changes due to temperature without impairing resistance changes due to strain.

[0153] [Relationships for rotational components (1)] The rotational component is the strain component of the torquer 30 that accompanies the rotation around the axis L1. For example, in the bridge circuit 120A, when measuring the strain component detected by the resistor R1, the resistor R2 is arranged rotated 90 degrees with respect to the resistor R1 when viewed in the facing direction. As a result, the resistance changes due to the strain gauges 71 and 72 are added together and doubled, and the resistance change due to temperature is cancelled. The "facing direction" here refers to the direction in which the strain gauges 71 and 72 face each other.

[0154] [Relationship between push and pull components (2)] The push-pull component is a strain component that accompanies the movement of the torquer 30 along the axial direction. For example, in the bridge circuit 120B, when measuring the strain component detected by the resistor R1, the resistor R2 is arranged rotated 90 degrees with respect to the resistor R1 when viewed in the facing direction. This causes the resistance changes due to the strain gauges 73 and 74 to be added together and doubled, and the resistance change due to temperature is cancelled. The "facing direction" here refers to the direction in which the strain gauges 73 and 74 face each other.

[0155] [Bridge output voltage e] Next, the bridge output voltage e in the bridge circuits 120A and 120B will be described. The bridge output voltage e is the voltage between the contact a and the contact d. The contact a is the contact between the resistor R1 and the resistor R2. The contact d is the contact between the resistor R3 and the resistor R4.

[0156] The bridge output voltage e can be calculated using the following equation (1).

number

[0157] In the bridge circuits 120A and 120B, the resistance values ​​R1 to R4 are adjusted so that the following formula (2) holds.

number

[0158] When the resistors R1 to R4 of the bridge circuit 120A are all composed of the resistors 82 of the strain gauges 71 and 72, the resistance values ​​R1, R2, R3, and R4 are R1+ΔR1+ΔR 1T ,R2+ΔR2+ΔR 2T ,R3+ΔR3+ΔR 3T ,R4+ΔR4+ΔR 4T When the resistances R1 to R4 of the bridge circuit 120B are all configured with the resistors 82 of the strain gauge 73 or the strain gauge 74, the output voltage e can be expressed by the following formula (3).

number

[0159] The following formula (4) shows the resistance change due to strain. The resistance change due to strain is the change in the resistance value of resistor 82 that accompanies the strain generated in torquer 30.

number

[0160] The following formula (5) shows the change in resistance due to a change in temperature.

number

[0161] When the temperature change coefficients of "resistance value R1 and resistance value R2" and "resistance value R3 and resistance value R4" are the same, "ΔR 1T = ΔR 2T " and "ΔR 3T = ΔR 4T " At this time, the resistance change due to temperature is cancelled out.

[0162] Therefore, the following equation (6) holds.

number

[0163] The output voltage e of the bridge circuits 120A and 120B is converted to a digital value by the AFE 211. As described above, the AFE 211 converts the output voltage e of the bridge circuits 120A and 120B to a digital value in step S21. After transmitting the measurement start command, the PC 230 continues to receive the digital value from the microcomputer 212. The bridge circuits 120A and 120B output a value obtained by canceling the output change due to temperature as the output voltage e.

[0164] [Effects of the catheter 100 according to the embodiment] The catheter 100 of the embodiment includes a plurality of strain gauges (first strain gauges) 71, 72 that detect strain generated in the cylindrical body when the guidewire 10 is rotated, and a plurality of strain gauges (second strain gauges) 73, 74 that detect strain generated in the cylindrical body when the guidewire 10 is pushed and pulled, the plurality of strain gauges 71, 72 are arranged opposite each other along the radial direction of the guidewire 10, the gauge direction G1 of the plurality of strain gauges 71, 72 is arranged so as to intersect both a first direction along the longitudinal direction of the guidewire 10 and a second direction perpendicular to the first direction, when viewed in the radial direction of the guidewire 10, and is also arranged so as to be perpendicular to each other, and each resistor 82 of the plurality of strain gauges 71, 72 is connected to constitute resistors R1 to R4 of a bridge circuit (first bridge circuit) 120A.

[0165] 5 and 7, the gauge direction G1 of the strain gauge 71 and the gauge direction G1 of the strain gauge 72 are disposed so as to be perpendicular to each other when viewed in the radial direction of the guidewire 10. Moreover, when viewed in the radial direction of the guidewire 10, the gauge direction G1 intersects both a first direction along the axial direction (a first direction along the longitudinal direction of the guidewire 10) and a second direction perpendicular to the axial direction. Specifically, the gauge direction G1 is inclined at 45 degrees with respect to the axial direction when viewed in the radial direction of the guidewire 10.

[0166] In such a catheter 100, the temperature compensation function cancels the resistance change due to the temperature of the resistors 82 of the strain gauges 71, 72. Also, in such a catheter 100, the output voltage e of the bridge circuit 120A is increased. In the catheter 100, the influence of temperature change is suppressed, and the strain generated in the torquer 30 can be detected with high accuracy.

[0167] In addition, in the catheter 100, the multiple strain gauges (second strain gauges) 73, 74 are arranged opposite each other along the radial direction of the guidewire 10, and the gauge directions G1 of the multiple strain gauges 73, 74 are arranged, as viewed in the radial direction of the guidewire 10, along a first direction along the longitudinal direction of the guidewire 10 and a second direction perpendicular to the first direction, respectively, and each resistor 82 of the multiple strain gauges 73, 74 is connected to form resistors R1 to R4 of the bridge circuit (second Wheatstone bridge circuit) 120B.

[0168] In such a catheter 100, the temperature compensation function cancels the resistance change due to temperature of the resistors 82 of the strain gauges 73, 74. Also, in such a catheter 100, the output voltage e of the bridge circuit 120B is increased. In the catheter 100, the influence of temperature change is suppressed, and the strain generated in the torquer 30 can be detected with high accuracy.

[0169] [Bridge circuits 120A and 120B according to the second embodiment] Next, the bridge circuits 120A, 120B according to the second embodiment will be described. The bridge circuits 120A, 120B according to the second embodiment differ from the bridge circuits 120A, 120B according to the first embodiment in that the bridge circuits 120A, 120B according to the second embodiment include resistors R3, R4 that are fixed resistors instead of resistors R3, R4 that are resistors 82 of the strain gauges 71 to 74. In the description of the bridge circuits 120A, 120B according to the second embodiment, the same description as for the bridge circuit 120B according to the first embodiment will be omitted.

[0170] [Bridge circuit 120A] The resistors 82 of the strain gauges 71 and 72 of the bridge circuit 120A form the resistors R1 and R2 of the bridge circuit 120A. The bridge circuit 120A according to the second embodiment is an example of the case where "the resistors of the first strain gauge are connected to form a part of the first bridge circuit".

[0171] The resistor R1 of the bridge circuit 120A may be the resistor 82 of the strain gauge 71. The resistor R2 of the bridge circuit 120A may be the resistor 82 of the strain gauge 72. The resistor R3 of the bridge circuit 120A is a fixed resistor. The resistor R4 of the bridge circuit 120A is a fixed resistor. [Bridge circuit 120B] The resistors 82 of the strain gauges 73 and 74 of the bridge circuit 120B form the resistors R1 and R2 of the bridge circuit 120B. The bridge circuit 120A according to the second embodiment is an example of the case where "the resistors of the second strain gauge are connected to form a part of the second Wheatstone bridge circuit".

[0172] The resistor R1 of the bridge circuit 120B may be the resistor 82 of the strain gauge 71. The resistor R2 of the bridge circuit 120B may be the resistor 82 of the strain gauge 72. The resistor R3 of the bridge circuit 120B is a fixed resistor. The resistor R4 of the bridge circuit 120B is a fixed resistor.

[0173] [Bridge output voltage e] Next, the bridge output voltage e in the bridge circuits 120A and 120B will be described.

[0174] When the resistors R1 and R2 of the bridge circuit 120A are composed of strain gauges 71 and 72, and the resistors R3 and R4 are composed of fixed resistors, the resistance values ​​R1R2, R3, and R4 are R1+ΔR1+ΔR 1T ,R2+ΔR2+ΔR 2T , R3 + ΔR 3T , R4 + ΔR 4T When the resistances R1 and R2 of the bridge circuit 120B are configured with the strain gauges 73 and 74, and the resistances R3 and R4 are configured with fixed resistors, the same applies.

[0175]

number

[0176] The following formula (8) shows the resistance change due to strain. The resistance change due to strain is the change in the resistance value of resistor 82 that accompanies the strain generated in torquer 30.

number

[0177] The following formula (9) shows the change in resistance due to a change in temperature.

number

[0178] When the temperature change coefficients of "resistance value R1 and resistance value R2" and "resistance value R3 and resistance value R4" are the same, "ΔR 1T = ΔR 2T " and "ΔR 3T = ΔR 4T " At this time, the resistance change due to temperature is cancelled out.

[0179] Therefore, the following equation (10) holds.

number

[0180] [Effects of the catheter 100 according to the embodiment] The catheter 100 of the embodiment includes a plurality of strain gauges (first strain gauges) 71, 72 that detect strain generated in the cylindrical body when the guidewire 10 is rotated, and a plurality of strain gauges (second strain gauges) 73, 74 that detect strain generated in the cylindrical body when the guidewire 10 is pushed and pulled, the plurality of strain gauges 71, 72 are arranged opposite each other along the radial direction of the guidewire 10, the gauge directions G1 of the plurality of strain gauges 71, 72 are arranged so as to intersect both a first direction along the longitudinal direction of the guidewire 10 and a second direction perpendicular to the first direction, when viewed in the radial direction of the guidewire 10, and are also arranged so as to be perpendicular to each other, and each resistor 82 of the plurality of strain gauges 71, 72 is connected to form resistors R1, R2 of a bridge circuit (first Wheatstone bridge circuit) 120A.

[0181] In such a catheter 100, the temperature compensation function cancels the resistance change due to the temperature of the resistors 82 of the strain gauges 71, 72. Also, in such a catheter 100, the output voltage e of the bridge circuit 120A is increased. In the catheter 100, the influence of temperature change is suppressed, and the strain generated in the torquer 30 can be detected with high accuracy.

[0182] In addition, in the catheter 100, the multiple strain gauges (second strain gauges) 73, 74 are arranged opposite each other along the radial direction of the guidewire 10, and the gauge directions G1 of the multiple strain gauges 73, 74 are arranged, when viewed in the radial direction of the guidewire 10, along a first direction along the longitudinal direction of the guidewire 10 and a second direction perpendicular to the first direction, respectively, and each resistor 82 of the multiple strain gauges 73, 74 is connected to form resistors R1, R2 of the bridge circuit (second Wheatstone bridge circuit) 120B.

[0183] In such a catheter 100, the temperature compensation function cancels the resistance change due to temperature of the resistors 82 of the strain gauges 73, 74. Also, in such a catheter 100, the output voltage e of the bridge circuit 120B is increased. In the catheter 100, the influence of temperature change is suppressed, and the strain generated in the torquer 30 can be detected with high accuracy.

[0184] In addition, the present invention is not limited to the configuration shown here, and may be implemented in other embodiments in which other components are combined with the configurations and the like of the above-mentioned embodiment. In this regard, the present invention may be modified within the scope of the gist of the present invention, and may be appropriately determined according to the application form.

[0185] In the above embodiment, the case where the strain gauge is provided in the operation component 60 is exemplified, but the position where the strain gauge is provided is not limited to the operation component 60. The strain gauge may be provided, for example, in the center maintaining component 40 or the holding component 50. The strain gauge may be provided on the base end side of the operation component 60, or may be provided inside the operation component 60. The strain gauge may be attached to, for example, another component attached to the operation component 60. The strain gauge may be any one that can detect strain generated when operating the guidewire 10 and generates an analog signal corresponding to the strain. [Explanation of symbols]

[0186] 100: catheter, 10: guide wire, 11: tip portion, 12: base end portion, 30: torquer, 40: center maintaining part, 50: holding part, 60: operation part (cylinder), 61: tip portion (tip portion of torquer), 61a: outer circumferential surface (outer circumferential surface of tip portion of torquer), 70: strain detection part (multiple strain gauges), 71, 72: strain gauge (first strain gauge), 73, 74: strain gauge (second strain gauge), 82: resistor 82 (strain gauge resistor), 120A: bridge circuit (first Wheatstone bridge circuit), 120B: bridge circuit (second Wheatstone bridge circuit), 200: catheter system, 211: AFE (analog-to-digital converter), 230: PC (control unit, processing unit), 231: display unit (alarm unit, output unit), 217: buzzer (alarm unit, audio output unit), 331: display area (first display area), 332: display area (second display area), G1: gauge direction.

Claims

1. A guidewire; a rod-shaped torquer that is connected to the guide wire and is held by an operator when operating the guide wire; A strain gauge provided in the torquer for detecting a strain of the torquer; An alarm unit that alarms a detection result by the strain gauge; A control unit that controls an operation of the notification unit, The control unit determines whether the detection result by the strain gauge exceeds a judgment threshold, and if the detection result exceeds the judgment threshold, causes the alarm unit to notify the detection result in an emphasized manner compared to a case in which the detection result does not exceed the judgment threshold.

2. The strain gauge comprises: a first strain gauge for detecting a strain caused by rotation of the torquer around an axis along a longitudinal direction of the guide wire; The notification unit has a display unit that displays the detection result, The catheter system according to claim 1 , wherein the control unit causes the display unit to perform a display according to a direction and a magnitude of the torque that is a detection result by the first strain gauge.

3. The strain gauge comprises: a second strain gauge for detecting a strain caused by movement of the torquer along the longitudinal direction of the guide wire; The display unit is a first display area that changes color depending on the magnitude of the detection result by the first strain gauge; The catheter system according to claim 2 , further comprising: a second display area that changes color depending on the magnitude of the detection result by the second strain gauge.

4. The notification unit has a sound output unit that outputs a sound in response to the detection result, The catheter system according to claim 1, wherein the control unit determines whether or not the detection result by the strain gauge exceeds a judgment threshold, and when the detection result exceeds the judgment threshold, causes the audio output unit to output a voice that is emphasized compared to when the detection result does not exceed the judgment threshold.

5. The catheter system according to claim 4, wherein the control unit outputs an alarm sound in an emphasized manner by increasing the number of times per unit time when the detection result by the strain gauge is large compared to when the detection result is small.

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