Sensor-equipped medical device

Abstract

This sensor-equipped medical device comprises: a sensor; a core shaft; and wiring that has a cross-sectional shape in which the thickness direction is smaller than the width direction, the wiring being such that a conductive wire electrically connected to the sensor is disposed on the inner side thereof, and the wiring being wound around the core shaft in a state in which the thickness direction continuously extends along the radial direction of the core shaft within a prescribed range in the long axis direction of the core shaft.

Description

Sensor-equipped medical devices

[0001] The present disclosure relates to sensor-equipped medical devices.

[0002] Medical devices with sensors attached to their distal ends are known. For example, Patent Literature 1 discloses an intravascular device having a sensing element, a core member, multiple communication lines wound around the core member, and a polymer jacket. Hereinafter, the core member will also be referred to as a "core shaft." The communication lines will also be referred to as "wiring."

[0003] Special table 2018-516623 publication

[0004] When passing through a curved portion of a blood vessel, the sensor-equipped medical device is bent to follow the curve of the blood vessel. When bending stress is applied to the sensor-equipped medical device, the core shaft bends, causing problems such as twisting of the wiring or pulling of the wiring. The intravascular device described in Patent Document 1 does not take such problems into consideration at all.

[0005] The present disclosure has been made to solve at least some of the above-mentioned problems, and aims to reduce the load on wiring in a medical device with a sensor.

[0006] The present disclosure has been made to solve at least part of the above-mentioned problems, and can be realized in the following aspects.

[0007] (1) According to one aspect of the present disclosure, there is provided a medical device with a sensor, the medical device with a sensor comprising: a core shaft; and a wiring having a cross-sectional shape in which the thickness direction is smaller than the width direction, the wiring having a conductor electrically connected to the sensor disposed on the inside thereof, and the wiring wound around the core shaft within a predetermined range in the longitudinal direction of the core shaft with the thickness direction continuously aligned with the radial direction of the core shaft.

[0008] According to this configuration, the wiring is wound around the core shaft with its thickness continuously aligned along the radial direction of the core shaft. Therefore, even if bending stress is applied to the sensor-equipped medical device and the core shaft is bent, the wiring is less likely to rotate on its own axis on the outer circumferential surface of the core shaft, and twisting of the wiring is suppressed. As a result, the load on the wiring during use of the sensor-equipped medical device can be reduced.

[0009] (2) In the sensor-equipped medical device of the above embodiment, the core shaft may have a tapered section in at least a portion of the predetermined range, the outer diameter of which narrows from the base end to the tip. With this configuration, the tapered section allows the core shaft to gradually change in rigidity. The tapered section is provided in at least a portion of the predetermined range in which the wiring is wound around the core shaft. Therefore, even if the core shaft is bent, the wiring moves toward the tip of the tapered section, thereby reducing the tensile load on the wiring. As a result, the load on the wiring during use of the sensor-equipped medical device can be further reduced.

[0010] (3) In the sensor-equipped medical device of the above embodiment, the wiring may be wound around the tapered portion of the core shaft. With this configuration, even if the core shaft is bent, the wiring moves toward the distal end of the tapered portion, thereby reducing the tensile load on the wiring. As a result, the load on the wiring during use of the sensor-equipped medical device can be further reduced.

[0011] (4) The medical device with sensor of the above embodiment may further include a coil covering at least a portion of the core shaft in the longitudinal direction of the core shaft. According to this configuration, the inclusion of the coil can improve the torque transmission of the medical device with sensor.

[0012] (5) In the sensor-equipped medical device of the above embodiment, the coil and the wiring may be wound in opposite directions. With this configuration, when the sensor-equipped medical device is rotated, the coil and the wiring are compressed in opposite directions. This reduces bias in the rotational operation performance of the sensor-equipped medical device and improves the torque transmission performance of the sensor-equipped medical device.

[0013] (6) In the medical device with a sensor of the above aspect, the core shaft may be a first core shaft, and may further include a second core shaft disposed closer to the base end than the first core shaft, with a gap between the distal end of the second core shaft and the proximal end of the first core shaft. With this configuration, by including the first core shaft and the second core shaft, a medical device with a sensor having a complex structure can be easily manufactured. The first core shaft and the second core shaft can be manufactured using different materials.

[0014] (7) The sensor-equipped medical device of the above embodiment may further include a tube that covers a portion of the first core shaft and at least a portion of the second core shaft and connects the first core shaft and the second core shaft. According to this configuration, connecting the first core shaft and the second core shaft with the tube can improve torque transmission. The tube can block noise from outside the sensor-equipped medical device and improve the accuracy of signals transmitted by wiring.

[0015] (8) In the medical device with a sensor of the above aspect, the conductor may be a first conductor, and the wiring may have a second conductor bundled together with the first conductor. With this configuration, the wiring has the second conductor bundled together with the first conductor, and therefore can transmit two signals output from the sensor.

[0016] (9) In the medical device with sensor of the above aspect, the wiring may have a pair of opposing main surfaces and a pair of opposing side surfaces, and the wiring may be wound around the core shaft with a first main surface of the pair of main surfaces continuously facing the outer circumferential surface of the core shaft. According to this configuration, the wiring is wound around the core shaft with a first main surface of the pair of main surfaces continuously facing the outer circumferential surface of the core shaft. Therefore, even if the core shaft is bent, the wiring is less likely to rotate on its own axis on the surface of the core shaft, and twisting of the wiring is suppressed.

[0017] (10) In the medical device with sensor of the above aspect, the wire may be slidable relative to the core shaft in at least a part of the predetermined range. With this configuration, the wire is slidable relative to the core shaft in at least a part of the predetermined range in which the wire is wound around the core shaft. Therefore, the wire moves in accordance with bending of the core shaft, thereby reducing the tensile load on the wire.

[0018] (11) In the medical device with a sensor of the above aspect, the wiring may further have a covering portion that covers an outer circumferential surface of the conductor. According to this configuration, the covering portion can electrically insulate the conductor.

[0019] (12) In the medical device with a sensor of the above aspect, the core shaft may penetrate the sensor in the longitudinal direction. With this configuration, a rotational force or a pushing force applied to the medical device with a sensor can be easily transmitted to the sensor at the distal end.

[0020] (13) The medical device with a sensor of the above aspect may have an adhesive layer that bonds the core shaft and the wiring. According to this configuration, the adhesive layer can fix at least a portion of the wiring to the core shaft.

[0021] The present disclosure can be realized in various forms, such as a medical device with a sensor, a core shaft and wiring components of a medical device with a sensor, a catheter including a medical device with a sensor, and methods of manufacturing these.

[0022] 10. An explanatory diagram illustrating the configuration of a medical device with a sensor. An enlarged cross-sectional view of the distal end side of a medical device with a sensor. An explanatory diagram illustrating the configuration of a tubular member. An explanatory diagram illustrating the configuration of a sensor sheet. An explanatory diagram for explaining a method of manufacturing a sensor. An explanatory diagram illustrating the configuration of a wiring. An enlarged view of the proximal end side of a medical device with a sensor. An explanatory diagram illustrating the configuration of a connector. An explanatory diagram illustrating the configuration of the proximal end of a wiring. An enlarged view of wiring wound around a first core shaft. A diagram showing an example of a cross section taken along line A-A in FIG. 10. A diagram showing another example of a cross section taken along line A-A in FIG. 10. An explanatory diagram illustrating the configuration of a medical device with a sensor of a second embodiment. An explanatory diagram showing the configuration of a wiring of a third embodiment. An explanatory diagram illustrating the configuration of a medical device with a sensor of a fourth embodiment. An explanatory diagram illustrating the configuration of a medical device with a sensor of a fifth embodiment. An explanatory diagram illustrating the configuration of a medical device with a sensor of a sixth embodiment. An explanatory diagram illustrating the configuration of a medical device with a sensor of a seventh embodiment. A diagram showing an example of a cross section taken along line A-A in FIG. 10 in an eighth embodiment.

[0023] First Embodiment Fig. 1 is an explanatory diagram illustrating the configuration of a sensor-equipped medical device 1. In Fig. 1, a sensor 20 and a connector 40 are shown as external configurations, and the remaining portions are shown as longitudinal cross-sectional configurations. The sensor-equipped medical device 1 is a device that is inserted into, for example, a cerebral blood vessel and measures the electrical resistance of a body fluid such as blood flowing through the vessel. The sensor-equipped medical device 1 is a sensor-equipped guidewire. The electrical resistance detected by the sensor-equipped medical device 1 is used, for example, to determine the type of thrombus that has occurred in a cerebral blood vessel.

[0024] In FIG. 1, the axis passing through the center of the sensor-equipped medical device 1 is represented by axis O. Hereinafter, the central axes passing through the centers of at least the first core shaft 11, the second core shaft 12, the first coil 60, the second coil 70, the tube 80, and the first tube 41a to the sixth tube 41f among the components of the sensor-equipped medical device 1 will be described as coinciding with axis O. The central axes passing through the centers of the components of the sensor-equipped medical device 1 may differ from axis O. FIG. 1 illustrates X, Y, and Z axes that are orthogonal to each other. The X axis corresponds to the longitudinal direction of the sensor-equipped medical device 1, in other words, the long axis direction of the sensor-equipped medical device 1. The Y axis corresponds to the width direction of the sensor-equipped medical device 1. The Z axis corresponds to the height direction of the sensor-equipped medical device 1. The +X axis direction in FIG. 1 is referred to as the "distal side" of the sensor-equipped medical device 1 and each component. The -X axis direction in FIG. 1 is referred to as the "proximal side" of the sensor-equipped medical device 1 and each component. For the sensor-equipped medical device 1 and each of its components, one end located on the distal side is referred to as the "distal end," and the other end located on the proximal side is referred to as the "proximal end." For the sensor-equipped medical device 1 and each of its components, the distal end and its vicinity are referred to as the "distal portion," and the proximal end and its vicinity are referred to as the "proximal end portion." The distal side is inserted into the living body, and the proximal side is operated by an operator such as a doctor. These points are also common to Figure 2 and subsequent figures. In this embodiment, "same" and "equal" mean roughly the same, allowing for variations due to manufacturing errors, etc. In this embodiment, "substantially constant" means roughly constant, allowing for variations due to manufacturing errors, etc.

[0025] The medical device 1 with sensor comprises a first core shaft 11, a second core shaft 12, a sensor 20, wiring 30, a connector 40, a distal tip 50, a first coil 60, a second coil 70, and a tube 80.

[0026] The first core shaft 11 is a solid member having an elongated shape extending along the X-axis direction. The first core shaft 11 has, in order from the distal end 111 to the proximal end 112, a first portion 115, a second portion 116, a third portion 117, and a fourth portion 118. The outer circumferential surface of the first core shaft 11 is covered with a first insulating tube 15 having insulating properties. In other words, the first core shaft 11 includes the first insulating tube 15.

[0027] The first portion 115 is the portion located closest to the tip of the first core shaft 11. The first portion 115 is a portion obtained by pressing the portion of the first core shaft 11 with the smallest outer diameter. The number of times and degree of pressing for the first portion 115 may be determined as desired. The second portion 116 is a portion located between the first portion 115 and the third portion 117. The outer diameter of the tip of the second portion 116 is the same as the outer diameter of the base end of the first portion 115. The outer diameter of the base end of the second portion 116 is the same as the outer diameter of the tip of the third portion 117. The second portion 116 has a gently tapered shape in which the outer diameter gradually decreases from the base end to the tip. The third portion 117 is a portion located between the second portion 116 and the fourth portion 118. The outer diameter of the tip of the third portion 117 is the same as the outer diameter of the base end of the second portion 116. The outer diameter of the base end of the third portion 117 is the same as the outer diameter of the tip end of the fourth portion 118. The third portion 117 has a tapered shape in which the outer diameter gradually decreases from the base end to the tip end. The taper gradient of the third portion 117 is greater than the taper gradient of the second portion 116. The second portion 116 is a tapered portion. The third portion 117 is also a tapered portion. The fourth portion 118 is the portion of the first core shaft 11 provided closest to the base end. The fourth portion 118 is the portion of the first core shaft 11 with the largest outer diameter, and has a substantially cylindrical shape with a substantially constant outer diameter. The outer diameters, lengths in the direction of the axis O, and cross-sectional shapes of the first portion 115, second portion 116, third portion 117, and fourth portion 118 can be determined arbitrarily.

[0028] The second core shaft 12 is a solid member having an elongated shape extending along the X-axis direction. The second core shaft 12 is disposed coaxially with the first core shaft 11, closer to the base end than the first core shaft 11. A gap 13 is formed between the first core shaft 11 and the second core shaft 12. The gap 13 is formed by separating the base end surface of the first core shaft 11 from the tip end surface of the second core shaft 12. The second core shaft 12 has a fifth portion 125, a sixth portion 126, and a seventh portion 127, in that order from the tip end 121 to the base end 122. The outer circumferential surface of the second core shaft 12 is covered with a second insulating tube 16 having insulating properties. In other words, the second core shaft 12 includes the second insulating tube 16.

[0029] The fifth portion 125 is the portion located closest to the distal end of the second core shaft 12. The fifth portion 125 is the portion of the second core shaft 12 with the smallest outer diameter and has a generally cylindrical shape with a generally constant outer diameter. The sixth portion 126 is the portion located between the fifth portion 125 and the sixth portion 126. The outer diameter of the distal end of the sixth portion 126 is the same as the outer diameter of the proximal end of the fifth portion 125. The outer diameter of the proximal end of the sixth portion 126 is the same as the outer diameter of the distal end of the seventh portion 127. The sixth portion 126 has a tapered shape in which the outer diameter gradually decreases from the proximal end to the distal end. The seventh portion 127 is the portion located closest to the proximal end of the second core shaft 12. The seventh portion 127 has a tapered shape in which the outer diameter gradually increases from the proximal end to the distal end. The seventh portion 127 is exposed to the outside from the proximal end of the connector 40. The outer diameter, length in the direction of the axis O, and cross-sectional shape of the fifth portion 125, the sixth portion 126, and the seventh portion 127 can be determined arbitrarily.

[0030] The first coil 60 and the second coil 70 are flexible cylindrical coils having a substantially constant outer diameter from the proximal end to the distal end. The first coil 60 and the second coil 70 are multi-strand coils formed by winding a plurality of wires in a multi-strand configuration. The first coil 60 is disposed distally of the sensor 20. The first coil 60 surrounds the outer periphery of the first portion 115 of the first core shaft 11, which protrudes distally from the sensor 20. The second coil 70 is disposed proximally of the sensor 20. The second coil 70 surrounds the outer periphery of a portion of the distal side of the second portion 116, the third portion 117, and the fourth portion 118 of the first core shaft 11. The first coil 60 and the second coil 70 can be formed of any material. The first coil 60 and the second coil 70 can be formed using at least one of a stainless steel alloy, a superelastic alloy, a radiolucent alloy, and a radiopaque alloy. Examples of stainless steel alloys include SUS304 and SUS316. Examples of superelastic alloys include nickel titanium and nickel titanium alloys. Examples of radiolucent alloys include piano wire, nickel-chromium alloys, and cobalt alloys. Examples of radiopaque alloys include gold, platinum, tungsten, and alloys containing these elements.

[0031] The first coil 60 and the second coil 70 may be single-filament coils formed by winding a single strand of wire. The first coil 60 and the second coil 70 may be single-filament stranded coils formed by winding a strand of wire obtained by twisting multiple strands of wire together. The first coil 60 and the second coil 70 may be multi-filament stranded coils formed by using multiple strands of wires twisted together and winding each strand of wire together in multiple strands. The first coil 60 and the second coil 70 may be the same type of coil or different types of coils. The outer diameter and inner diameter of the first coil 60 and the second coil 70 can be determined arbitrarily.

[0032] The tube 80 has a substantially cylindrical shape. The tube 80 has a distal end portion 81 and a main body portion 82. The distal end portion 81 is a tapered portion whose outer diameter gradually decreases from the base end toward the tip. The main body portion 82 is a portion having a substantially constant outer diameter. The tube 80 has a lumen with a substantially constant inner diameter. A proximal portion of the first core shaft 11, a distal portion of the second core shaft 12, and the wiring 30 pass through the lumen of the tube 80. A gap 13 is provided in the lumen of the tube 80. The tube 80 is fixed to the first core shaft 11 and the second core shaft 12, thereby improving the rigidity of the sensor-equipped medical device 1. In other words, the tube 80 covers a proximal portion of the first core shaft 11 and a distal portion of the second core shaft 12, and connects the first core shaft 11 and the second core shaft 12. The tube 80 can be made of, for example, at least one of nickel titanium and a nickel titanium alloy.

[0033] The distal tip 50 is a member that joins the distal end 111 of the first core shaft 11 to the distal end of the first coil 60. The second joint 52 is a member that joins the base end of the first coil 60, the distal end of the tube 80, and a portion of the first core shaft 11. The third joint 53 is a member that joins the base end of the tube 80, the connector 40, and a portion of the second core shaft 12. The distal tip 50, the second joint 52, and the third joint 53 can be formed using any bonding agent. For example, at least one of silver brazing, gold brazing, zinc, metal solder such as Sn—Ag alloy, or Au—Sn alloy, and adhesives such as epoxy adhesives can be used as the bonding agent.

[0034] Figure 2 is an enlarged cross-sectional view of the distal end side of the sensor-equipped medical device 1. The sensor 20 shown in Figure 2 is disposed at the distal end of the sensor-equipped medical device 1. The sensor 20 is a structure including a sensor element that measures the electrical resistance of bodily fluids such as blood flowing through a blood vessel. The first part 115 of the first core shaft 11 passes through the inside of the sensor 20. In other words, the first core shaft 11 penetrates the sensor 20 in the X-axis direction. The sensor 20 includes a tubular member 22, a sensor sheet 24, spacers 26 and 28, and a first joint 51.

[0035] FIG. 3 is an explanatory diagram showing the configuration of the tubular member 22. The tubular member 22 has a base end tubular portion 22a, an intermediate connecting portion 22b, and a distal end tubular portion 22c. The base end tubular portion 22a is a substantially cylindrical portion located on the base end side of the tubular member 22. A linear slit 22s is formed on the side surface of the base end tubular portion 22a, penetrating the inside and outside of the cylinder. The intermediate connecting portion 22b is a portion provided between the base end tubular portion 22a and the distal end tubular portion 22c. The cross section of the intermediate connecting portion 22b is semicircular. In other words, the inner surface of the cylinder is exposed to the outside at the intermediate connecting portion 22b. The distal end tubular portion 22c is a substantially cylindrical portion located on the distal end side of the tubular member 22. No slit is formed on the side surface of the distal end tubular portion 22c. The tubular member 22 can be formed from any resin material.

[0036] 4 is an explanatory diagram showing the configuration of the sensor sheet 24. The sensor sheet 24 is a sheet-like member and includes a sensor array 24s, a microchip 24m, a wide portion 24a, a narrow portion 24b, and sensor wiring 24c.

[0037] The sensor array 24s includes nine sensor elements arranged in a grid pattern. The sensor elements measure the electrical resistance of bodily fluids such as blood flowing through blood vessels. The microchip 24m transmits a signal representing the measurement value obtained by the sensor array 24s. The widened portion 24a is a wide, strip-shaped sheet on which the sensor array 24s is disposed. The narrowed portion 24b is a strip-shaped sheet narrower than the widened portion 24a on which the microchip 24m is disposed. The sensor wiring 24c is a wiring that transmits the signal transmitted by the microchip 24m. The sensor wiring 24c is electrically connected to the tip of the wiring 30.

[0038] FIG. 5 is an explanatory diagram illustrating a method for fabricating the sensor 20. The worker can fabricate the sensor 20 in the following procedure. The worker prepares the tubular member 22, the sensor sheet 24, the spacer 26, and the spacer 28. The spacers 26 and 28 are annular members having an inner diameter slightly larger than that of the tubular member 22. The spacers 26 and 28 can be formed from any resin material. The worker inserts the sensor sheet 24 into the inside of the tubular member 22 through the slit 22s. As shown in FIG. 5, the widened portion 24a and the narrowed portion 24b of the sensor sheet 24 protrude outside the tubular member 22. The worker inserts the tip end of the first core shaft 11 into the inside of the tubular member 22. The worker fits the annular spacer 26 into the tubular member 22, starting from the end on the proximal cylindrical portion 22a side. The operator fits the annular spacer 28 into the tubular member 22, starting from the end near the distal end tubular portion 22c. Then, as shown in FIG. 5, the annular spacers 26, 28 hold the tubular member 22 and the sensor sheet 24 in the state shown in FIG. 5. The operator then wraps the sensor sheet 24 around the tubular member 22 and the spacers 26, 28. Then, the narrow portion 24b of the sensor sheet 24 is positioned to cover the outer periphery of the intermediate connection portion 22b. As shown in FIG. 2, when the sensor sheet 24 is wrapped around the tubular member 22, one microchip 24m on the narrow portion 24b is stacked on top of another microchip 24m. The wide portion 24a of the narrow portion 24b is wrapped around the outer periphery of the spacers 26, 28. As a result, the nine sensor elements of the sensor array 24s are positioned at the outermost periphery of the sensor 20. In other words, three sensor elements are arranged at intervals of 120° along the circumferential direction.

[0039] Returning to FIG. 2 , the explanation continues. The first joint 51 is a member that joins the sensor 20, the first core shaft 11, the first coil 60, and the second coil 70. The first joint 51 is disposed inside the tubular member 22 of the sensor 20 and joins the sensor 20 to the first core shaft 11. The first joint 51 is disposed on the outer periphery of the sensor 20, closer to the distal end than the spacer 28, and joins the sensor 20 to the first coil 60. The first joint 51 is disposed on the outer periphery of the sensor 20, closer to the proximal end than the spacer 26, and joins the sensor 20 to the second coil 70. The first joint 51 can be formed using any bonding agent. Examples of bonding agents that can be used include at least one of silver solder, gold solder, zinc, metal solder such as Sn—Ag alloy, and Au—Sn alloy, and adhesives such as epoxy adhesives. As shown in FIG. 2 , the outer diameter Φ60 of the first coil 60 is equal to the outer diameter Φ70 of the second coil 70. The outer diameter Φ20 of the sensor 20 is smaller than the outer diameter Φ60 of the first coil 60. The outer diameter Φ20 of the sensor 20 is smaller than the outer diameter Φ70 of the second coil 70.

[0040] FIG. 6 is an explanatory diagram showing the configuration of the wiring 30. The wiring 30 is a connecting wire that electrically connects the sensor 20 and the connector 40. As shown in FIG. 1, the tip end 31 of the wiring 30 is electrically connected to the sensor 20. The base end 36 of the wiring 30 is electrically connected to the connector 40. The wiring 30 transmits signals from the sensor 20 to an external device via the connector 40. As shown in FIG. 6, the wiring 30 includes conductors 301a to 301e, inner coverings 302a to 302e, and an outer covering 303. The conductors 301a to 301e are a first conductor 301a, a second conductor 301b, a third conductor 301c, a fourth conductor 301d, and a fifth conductor 301e. The wiring 30 includes a first conductor 301a. The wiring 30 includes a second conductor 301b. The wiring 30 includes a third conductive wire 301c. The wiring 30 includes a fourth conductive wire 301d. The wiring 30 includes a fifth conductive wire 301e. The inner coated portions 302a to 302e are coated portions. The outer coated portion 303 is a coated portion.

[0041] The conductors 301a to 301e are conductive metal conductors. The inner coverings 302a to 302e are tubes formed from insulating resin. The inner covering 302a covers the outer surface of the conductor 301a. Similarly, the inner coverings 302b to 302e cover the outer surfaces of the conductors 301b to 301e, respectively. The inner coverings 302a to 302e can be formed from insulating resin, such as polyimide resin. The five conductors 301a to 301e are arranged horizontally in a row, each covered by an inner covering 302a to 302e. The outer covering 303 covers the outer surfaces of the conductors 301a to 301e and the inner coverings 302a to 302e, holding them together. The outer covering 303 can be formed from insulating resin, such as urethane resin.

[0042] In the wiring 30, the direction in which the conductive wires 301a to 301e and the inner coating portions 302a to 302e are arranged is also referred to as the "width direction." In the wiring 30, the direction perpendicular to the length direction and width direction is also referred to as the "thickness direction." As shown in FIG. 6 , the wiring 30 has a length T30 in the thickness direction that is smaller than its length W30 in the width direction. The wiring 30 has a flat cross-sectional shape in which the thickness direction is smaller than the width direction. The cross-section of the wiring 30 is non-circular. Of the pair of main surfaces of the wiring 30 that have relatively large areas, one is also referred to as the "first main surface MF1" and the other is also referred to as the "second main surface MF2." The first main surface MF1 and the second main surface MF2 face each other. Of the pair of side surfaces of the wiring 30 that have relatively small areas, one is also referred to as the "first side surface SF1" and the other is also referred to as the "second side surface SF2." The first side surface SF1 and the second side surface SF2 face each other. The first main surface MF1 is sandwiched between the first side surface SF1 and the second side surface SF2. The second main surface MF2 is sandwiched between the first side surface SF1 and the second side surface SF2.

[0043] Returning to Figure 1, the explanation will continue. The tip 31 of the wiring 30 is electrically connected to the sensor wiring 24c of the sensor 20 with the inner covering portions 302a to 302e and the outer covering portion 303 removed. The tip 31 of the wiring 30 is linear. "Electrically connected" means that the connection is such that a current can flow, in other words, that the connection is such that electrical continuity is possible.

[0044] The wiring 30 is spirally wound around the outer peripheral surface of the first core shaft 11 in the first section P1. The first section P1 is located closer to the base end than the sensor wiring 24c of the sensor 20 and closer to the tip end than the second joint 52. The wiring 30 in the first section P1 has a first roll portion 32, a second roll portion 33, and a third roll portion 34. In the first roll portion 32, the wiring 30 is loosely wound around the second portion 116 of the first core shaft 11. In the first roll portion 32, the spacing between adjacent wiring 30 gradually decreases from the tip end toward the base end. In the second roll portion 33, the wiring 30 is tightly wound around the third portion 117 and the fourth portion 118 of the first core shaft 11. In the third roll portion 34, the wiring 30 is loosely wound around the fourth portion 118 of the first core shaft 11. In the third roll portion 34, the spacing between adjacent wires 30 gradually increases from the distal end toward the proximal end. In other words, in the first roll portion 32 and the third roll portion 34, the spacing between adjacent wires 30 decreases toward the second roll portion 33. By winding the wires 30 around the first core shaft 11, the central axis of the first core shaft 11 can be kept aligned with the central axis O of the sensor-equipped medical device 1. As a result, stress concentration on one portion of the first core shaft 11 can be suppressed when the sensor-equipped medical device 1 is in use.

[0045] In the second section P2, the wiring 30 extends linearly along the outer circumferential surfaces of the first core shaft 11 and the second core shaft 12. In other words, the wiring 30 is not spiral in the second section P2. The second section P2 is a section that is proximal to the second joint 52 and extends to the inside of the connector 40. The wiring 30 in the second section P2 has a straight section 35 and a proximal end section 36. In the straight section 35, the wiring 30 extends linearly along the fourth section 118 of the first core shaft 11 and the fifth section 125 of the second core shaft 12. The wiring 30 also extends in the longitudinal direction of the sensor-equipped medical device 1 in the gap 13. In the proximal end section 36, the wiring 30 is inserted into the connector 40 and is electrically connected to the connector 40.

[0046] FIG. 7 is an enlarged view of the proximal end side of the sensor-equipped medical device 1. In FIG. 7, the external appearance of the sensor-equipped medical device 1 is represented by solid lines, and the connector 40 and the second core shaft 12 and wiring 30 disposed in the lumen of the tube 80 are represented by dashed lines. FIG. 8 is an explanatory diagram illustrating the configuration of the connector 40. The connector 40 is disposed at the proximal end of the sensor-equipped medical device 1. The connector 40 is a terminal connected to an external device that processes the output signal from the sensor 20. The second core shaft 12 and wiring 30 pass through the inside of the connector 40. The connector 40 is joined to the proximal end of the tube 80 by a third joint 53. As shown in FIG. 8, the connector 40 includes six tubes 41a to 41f and five insulators 43a to 43e.

[0047] The tubes 41a to 41f are conductive, hollow electrodes. In this embodiment, the tubes 41a to 41f have a cylindrical shape. The tubes 41a to 41f can be formed of a conductive metal, such as a platinum-iridium alloy. The first tube 41a is located at the most distal end of the connector 40 and closer to the proximal end than the sensor 20. The distal end surface of the first tube 41a is perpendicular to the X-axis direction. The proximal end surface of the first tube 41a is inclined with respect to the X-axis direction. The second tube 41b is located closer to the proximal end than the first tube 41a. The distal end surface of the second tube 41b is inclined with respect to the X-axis direction. The proximal end surface of the second tube 41b is inclined with respect to the X-axis direction. The distal end surface and proximal end surface of the second tube 41b are inclined with the same direction and angle of inclination. The third tube 41c is located closer to the proximal end than the second tube 41b. The fourth tube 41d is located closer to the base end than the third tube 41c. The fifth tube 41e is located closer to the base end than the fourth tube 41d. The third tube 41c, the fourth tube 41d, and the fifth tube 41e have the same configuration as the second tube 41b. The sixth tube 41f is located closest to the base end of the connector 40 and closer to the base end than the fifth tube 41e. The distal end surface of the sixth tube 41f is inclined with respect to the X-axis direction. The proximal end surface of the sixth tube 41f is perpendicular to the X-axis direction.

[0048] The insulators 43a-43e are insulating members that insulate adjacent tubes 41a-41f from each other. The insulators 43a-43e can be formed using an insulating adhesive, such as polyimide resin. The first insulator 43a is disposed between the first tube 41a and the second tube 41b and is sandwiched between the first tube 41a and the second tube 41b. As shown in the figure, a portion of the first insulator 43a is exposed to the outside. "Exposed to the outside" means that it is visible from the outside. The second insulator 43b is disposed between the second tube 41b and the third tube 41c and is sandwiched between the second tube 41b and the third tube 41c. A portion of the second conductor 42b is exposed to the outside. The third insulator 43c is disposed between the third tube 41c and the fourth tube 41d and is sandwiched between the third tube 41c and the fourth tube 41d. A portion of the third insulator 43c is exposed to the outside. The fourth insulator 43d is disposed between the fourth tube 41d and the fifth tube 41e and is sandwiched between the fourth tube 41d and the fifth tube 41e. A portion of the fourth insulator 43d is exposed to the outside. The fifth insulator 43e is disposed between the fifth tube 41e and the sixth tube 41f and is sandwiched between the fifth tube 41e and the sixth tube 41f. A portion of the fifth insulator 43e is exposed to the outside.

[0049] FIG. 9 is an explanatory diagram illustrating the configuration of the base end 36 of the wiring 30. As shown in FIG. 7, the base end 36 of the wiring 30 is disposed inside the first to fifth tubes 41a to 41e of the connector 40. As shown in FIG. 9, the wiring 30 has a portion of the inner covering 302a and the outer covering 303 peeled off at a position corresponding to the first tube 41a, exposing the conductor 301a. The exposed conductor 301a is electrically connected to the first tube 41a. The wiring 30 has a portion of the inner covering 302b and the outer covering 303 peeled off at a position corresponding to the second tube 41b, exposing the conductor 301b. The exposed conductor 301b is electrically connected to the second tube 41b. The wiring 30 has a portion of the inner covering 302c and the outer covering 303 peeled off at a position corresponding to the third tube 41c, exposing the conductor 301c. The exposed conductor 301c is electrically connected to the third tube 41c. The wiring 30 has a portion of the inner covering 302d and a portion of the outer covering 303 peeled off at a position corresponding to the fourth tube 41d, exposing the conductor 301d. The exposed conductor 301d is electrically connected to the fourth tube 41d. The wiring 30 has a portion of the inner covering 302e and a portion of the outer covering 303 peeled off at a position corresponding to the fifth tube 41e, exposing the conductor 301e. The exposed conductor 301e is electrically connected to the fifth tube 41e. In FIG. 7 , the fifth portion 125 of the second core shaft 12 is disposed inside the first tube 41a to the fifth tube 41e of the connector 40. The sixth portion 126 of the second core shaft 12 is disposed inside the sixth tube 41f of the connector 40. A seventh portion 127 of the second core shaft 12 protrudes outward from the base end of the connector 40 .

[0050] FIG. 10 is an enlarged view of the wiring 30 wound around the first core shaft 11. As shown in FIG. 1, the wiring 30 is spirally wound around the outer peripheral surface of the first core shaft 11 in the first section P1. The first section P1 can be a predetermined range in the longitudinal direction of the sensor-equipped medical device 1. As shown in FIG. 10, the wiring 30 is wound around the first core shaft 11 with the first main surface MF1 of the pair of main surfaces MF1, MF2 continuously facing the outer peripheral surface 11o of the first core shaft 11. "Continuously" means that all of the wiring 30 lined up in the X-axis direction on the outer peripheral surface of the first core shaft 11 are in the same state. That is, in the first section P1, the second main surface MF2 of the wiring 30, which is located opposite the first main surface MF1 from an external perspective, continuously faces outward.

[0051] In the example of FIG. 1 , the first roll portion 32 of the wiring 30 is located at a position corresponding to a portion of the base end side of the second portion 116 of the first core shaft 11. The second roll portion 33 of the wiring 30 is located at a position corresponding to the range from the base end of the second portion 116 to the tip end of the fourth portion 118 of the first core shaft 11. In other words, the third portion 117 of the first core shaft 11 is covered by the second roll portion 33 of the wiring 30. The third roll portion 34 of the wiring 30 is located at a position corresponding to a portion of the tip end side of the fourth portion 118 of the first core shaft 11. The second portion 116 and the third portion 117 of the first core shaft 11 are "tapered portions." The wiring 30 is wound around the tapered portions of the first core shaft 11.

[0052] The wiring 30 is fixed to the first core shaft 11 at two locations: the tip end 321 of the first roll portion 32 and the base end 341 of the third roll portion 34. The wiring 30 and the first core shaft 11 can be fixed together using any bonding agent, such as an epoxy adhesive. The entire wiring 30, excluding the tip end 321 of the first roll portion 32, the entire second roll portion 33, and the base end 341 of the third roll portion 34, is not fixed to the first core shaft 11. Therefore, the wiring 30 is slidable relative to the first core shaft 11 in the range from the tip end 321 of the first roll portion 32 to the base end 341 of the third roll portion 34. In other words, the wiring 30 can move relative to the first core shaft 11 in the range from the tip end 321 of the first roll portion 32 to the base end 341 of the third roll portion 34, thereby changing the relative position of the wiring 30 and the first core shaft 11.

[0053] In the example of Fig. 1, the wiring 30 is S-wound in the first section P1. In this case, it is preferable that the second coil 70 is wound in the opposite direction to the winding direction of the wiring 30, i.e., Z-wound. Fig. 1 is merely an example, and the wiring 30 may be Z-wound and the second coil 70 may be S-wound.

[0054] FIG. 11 is a diagram showing an example of a cross section taken along line A-A in FIG. 10 . FIG. 12 is a diagram showing another example of a cross section taken along line A-A in FIG. 10 . In the first section P1, the wiring 30 is wound around the first core shaft 11 with its thickness direction continuously aligned with the radial direction DD of the first core shaft 11. The thickness direction of the wiring 30 is the direction indicated by T30 in FIG. 11 . The phrase "the thickness direction aligned with the radial direction DD" means that the thickness direction and an imaginary extension of the radial direction DD generally coincide with each other, allowing for deviations due to manufacturing errors. As shown in FIG. 11 , the first main surface MF1 of the wiring 30 may be in contact with the outer circumferential surface 11o of the first core shaft 11. As shown in FIG. 12 , the first main surface MF1 of the wiring 30 may be spaced apart from the outer circumferential surface 11o of the first core shaft 11. In other words, a gap GA may be provided between the first main surface MF1 of the wiring 30 and the outer peripheral surface 11o of the first core shaft 11. The gap GA does not need to be provided continuously. In the first section P1, the wiring 30 may have a mixture of a portion where the first main surface MF1 and the outer peripheral surface 11o are in contact with each other and a portion where the gap GA is present. As described above, the first core shaft 11 includes the first insulating tube 15 having insulating properties. For this reason, in FIGS. 11 and 12 , the outer peripheral surface of the first insulating tube 15 is referred to as the outer peripheral surface 11o of the first core shaft 11.

[0055] According to the sensor-equipped medical device 1 of the first embodiment, the wiring 30 is wound around the first core shaft 11 with its thickness direction continuously aligned with the radial direction DD of the first core shaft 11. In other words, the wiring 30 is wound around the first core shaft 11 with the first main surface MF1 of the pair of main surfaces MF1, MF2 continuously facing the outer circumferential surface 11o of the first core shaft 11. Therefore, even if bending stress is applied to the sensor-equipped medical device 1 and the first core shaft 11 is bent, the wiring 30 is less likely to rotate on its own axis on the outer circumferential surface 11o of the first core shaft 11, and twisting of the wiring 30 is suppressed. As a result, the load on the wiring 30 during use of the sensor-equipped medical device 1 can be reduced.

[0056] According to the sensor-equipped medical device 1 of the first embodiment, the first core shaft 11 has tapered portions 116, 117. Therefore, the tapered portions 116, 117 of the first core shaft 11 allow gradual change in the rigidity of the first core shaft 11. The tapered portions 116, 117 are provided in at least a portion of the predetermined range P1 in which the wiring 30 is wound around the core shaft. Therefore, even when the first core shaft 11 is bent, the wiring 30 moves toward the distal end of the tapered portions 116, 117, thereby reducing the tensile load on the wiring 30. In other words, when the first core shaft 11 is bent, the wiring 30 moves in the direction indicated by the white arrow in FIG. 10 . As a result, the spacing between adjacent wirings 30 narrows in the first roll portion 32, and the spacing between adjacent wirings 30 widens in the second roll portion 33. In the tapered portions 116, 117, the outer diameter of the first core shaft 11 decreases toward the distal end. Therefore, if the wiring 30 is moved toward the distal end, there is more room in the length of the wiring 30 relative to the outer diameter of the first core shaft 11, thereby reducing the tensile load on the wiring 30. As a result, the load on the wiring 30 when the sensor-equipped medical device 1 is in use can be further reduced.

[0057] According to the medical device with sensor 1 of the first embodiment, the wiring 30 is slidable relative to the first core shaft 11 in at least a part of the predetermined range P1 in which the wiring 30 is wound around the first core shaft 11. Therefore, the wiring 30 moves in accordance with the bending of the first core shaft 11, thereby reducing the tensile load on the wiring 30.

[0058] According to the medical device with sensor 1 of the first embodiment, the wiring 30 has a plurality of bundled conductors 301a to 301e, and therefore can transmit a plurality of signals output from the sensor 20. According to the medical device with sensor 1 of the first embodiment, the wiring 30 has inner covering portions 302a to 302e and an outer covering portion 303 that cover the outer peripheral surfaces of the conductors 301a to 301e. Therefore, the covering portions 302a to 302e, 303 can electrically insulate the conductors 301a to 301e.

[0059] According to the sensor-equipped medical device 1 of the first embodiment, the sensor-equipped medical device 1 includes a first coil 60 and a second coil 70 that cover at least a portion of the first core shaft 11, thereby improving the torque transmissibility of the sensor-equipped medical device 1. According to the sensor-equipped medical device 1 of the first embodiment, the winding direction of the second coil 70 is opposite to the winding direction of the wiring 30. Therefore, when the sensor-equipped medical device 1 is rotated, the direction in which the coil 70 is compressed can be opposite to the direction in which the wiring 30 is compressed. As a result, it is possible to reduce bias in the rotational operation performance of the sensor-equipped medical device 1 and improve the torque transmissibility of the sensor-equipped medical device 1.

[0060] According to the sensor-equipped medical device 1 of the first embodiment, the first core shaft 11 penetrates the sensor 20 in the X-axis direction, which makes it easier to transmit a rotational force or a pushing force applied to the sensor-equipped medical device 1 to the sensor 20 at the tip.

[0061] According to the sensor-equipped medical device 1 of the first embodiment, the sensor-equipped medical device 1 has a first core shaft 11 and a second core shaft 12. This makes it possible to separately manufacture the portion associated with the first core shaft 11 and the portion associated with the second core shaft 12, making it easy to manufacture a sensor-equipped medical device 1 with a complex structure. The first core shaft 11 and the second core shaft 12 can be manufactured using different materials. According to the sensor-equipped medical device 1 of the first embodiment, torque transmission can be improved by connecting the first core shaft 11 and the second core shaft 12 with a tube 80. The tube 80 blocks noise from outside the sensor-equipped medical device 1, improving the accuracy of signals transmitted by the wiring 30.

[0062] <Second embodiment> Figure 13 is an explanatory diagram illustrating the configuration of a sensor-equipped medical device 1A of a second embodiment. The sensor-equipped medical device 1A of the second embodiment has a wiring 30A instead of the wiring 30 in the configuration described in the first embodiment. The wiring 30A does not have the first rolled portion 32 and the third rolled portion 34 described in the first embodiment. In other words, the wiring 30A has, from the distal end to the proximal end, a distal end portion 31, a rolled portion 33A, a straight portion 35, and a proximal end portion 36. In other words, the entire wiring 30A in the first section P1 is the rolled portion 33A.

[0063] In the roll portion 33A, the wire 30A is loosely wound around the first core shaft 11. In other words, in the roll portion 33A, the wire 30A is wound around the first core shaft 11 with a gap between adjacent wires 30A. The spacing between adjacent wires 30A is generally uniform. However, the spacing between adjacent wires 30A may be uneven. Other aspects of the wire 30A are the same as those in the first embodiment. For example, the wire 30A is wound around the first core shaft 11 with its thickness direction continuously aligned along the radial direction of the first core shaft 11, similar to the first embodiment. The wire 30A is slidable relative to the first core shaft 11 between the tip end portion 321 and the base end portion 341, similar to the first embodiment. The winding directions of the wire 30A and the second coil 70 are the same as those in the first embodiment.

[0064] As described above, the configuration of the wiring 30A can be modified in various ways. The wiring 30A in the first section P1 may be loosely wound as a whole. The wiring 30A in the first section P1 may be tightly wound as a whole. The wiring 30A may be configured such that only one of the first roll portion 32 and the third roll portion 34 described in the first embodiment is omitted. The medical device with sensor 1A of the second embodiment as described above can also achieve the same effects as the first embodiment.

[0065] 14 is an explanatory diagram showing the configuration of a wiring 30B of a third embodiment. A medical device with sensor 1B of the third embodiment has a wiring 30B instead of the wiring 30 in the configuration described in the first embodiment. The wiring 30B does not have the outer covering portion 303 described in the first embodiment.

[0066] The wiring 30B is formed by fixing the conductor wires 301a to 301e covered with the inner covering portions 302a to 302e together with a bonding agent. Any bonding agent, such as an epoxy adhesive, can be used as the bonding agent. The wiring 30B may also be formed by bundling the conductor wires 301a to 301e covered with the inner covering portions 302a to 302e with a bundling member. In this embodiment, the inner covering portions 302a to 302e are the covering portions. Other aspects of the wiring 30B are the same as those of the first embodiment.

[0067] As described above, the configuration of the wiring 30B can be modified in various ways. In the wiring 30B, the covering covering the outer circumferential surfaces of the conductor wires 301a to 301e may be a single layer. In the wiring 30B, the covering covering the outer circumferential surfaces of the conductor wires 301a to 301e may be three or more layers. If the covering arranged on the outermost periphery of the wiring 30B is made of a material with a low coefficient of friction, the movement of the wiring 30B when the first core shaft 11 is bent can be made smoother. The medical device with sensor 1B of the third embodiment described above can also achieve the same effects as the first embodiment. If the wiring 30B has the configuration shown in FIG. 14 , the flexibility of the wiring 30B can be improved compared to the first embodiment.

[0068] 15 is an explanatory diagram illustrating the configuration of a sensor-equipped medical device 1C of a fourth embodiment. The sensor-equipped medical device 1C of the fourth embodiment has the configuration described in the first embodiment, but includes a first core shaft 11C instead of the first core shaft 11. The first core shaft 11C has a fourth portion 118C instead of the second portion 116, third portion 117, and fourth portion 118 described in the first embodiment.

[0069] The fourth portion 118C is a portion located adjacent to the first portion 115, closer to the base end than the first portion 115. The fourth portion 118C is the portion of the first core shaft 11C with the largest outer diameter, and has a generally cylindrical shape with a generally constant outer diameter. The first core shaft 11C does not have a tapered portion. In this embodiment, the first roll portion 32 of the wiring 30 is located in a portion on the tip side of the fourth portion 118C of the first core shaft 11C. The second roll portion 33 of the wiring 30 is located in a portion near the center of the fourth portion 118C of the first core shaft 11C. The third roll portion 34 of the wiring 30 is located in a portion on the base end side of the fourth portion 118C of the first core shaft 11C. In other words, the roll portions 32, 33, and 34 of the wiring 30 are all located on the fourth portion 118C and are not located in the tapered portion.

[0070] As described above, the configuration of the sensor-equipped medical device 1C can be modified in various ways. The first core shaft 11C does not have to have a tapered portion. The wiring 30 does not have to be wound around the tapered portion. The first core shaft 11C does not have to have the first portion 115. Even in the sensor-equipped medical device 1C of the fourth embodiment described above, when the first core shaft 11C is bent, the wiring 30 can move into the gap between the first roll portion 32 and the third roll portion 34. Therefore, the same effects as in the first embodiment can be achieved.

[0071] 16 is an explanatory diagram illustrating the configuration of a sensor-equipped medical device 1D according to a fifth embodiment. The sensor-equipped medical device 1D of the fifth embodiment includes a distal tube 70D instead of the second coil 70 in the configuration described in the first embodiment.

[0072] The distal tube 70D is disposed proximal to the sensor 20. The distal tube 70D surrounds the outer periphery of the distal portions of the second portion 116, the third portion 117, and the fourth portion 118 of the first core shaft 11. The distal tube 70D is preferably antithrombogenic, flexible, and biocompatible, and can be formed from a resin or metal material. Examples of the resin material include at least one of polyimide resin, polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of the metal material include at least one of stainless steel, nickel-titanium alloy, and cobalt-chromium alloy. The distal end of the distal tube 70D is fixed to the sensor 20 by a first joint 51. The proximal end of the distal tube 70D is fixed to the first core shaft 11 and the tube 80 by a second joint 52.

[0073] As described above, the configuration of the sensor-equipped medical device 1D can be modified in various ways. The sensor-equipped medical device 1D does not need to include the second coil 70 described in the first embodiment. The sensor-equipped medical device 1D may also be configured without the first coil 60 in addition to the second coil 70. When the first coil 60 is omitted, the first portion 115 of the first core shaft 11, which is located more distal than the sensor 20, may be omitted. The sensor-equipped medical device 1D of the fifth embodiment as described above can also achieve the same effects as the first embodiment.

[0074] 17 is an explanatory diagram illustrating the configuration of a sensor-equipped medical device 1E of a sixth embodiment. The sensor-equipped medical device 1E of the sixth embodiment has the configuration described in the first embodiment, but includes a second coil 70E instead of the second coil 70, and does not include the tube 80.

[0075] The second coil 70E surrounds the outer periphery of the second portion 116, the third portion 117, and the fourth portion 118 of the first core shaft 11. The second coil 70E further surrounds the outer periphery of a portion on the distal side of the fifth portion 125 of the second core shaft 12. The second coil 70E extends from the base end of the sensor 20 to the tip of the connector 40. The tip end of the second coil 70E is fixed to the sensor 20 by a first joint portion 51. The middle portion of the second coil 70E is fixed to the first core shaft 11 by a second joint portion 52. The base end of the second coil 70E is fixed to the connector 40 and the second core shaft 12 by a third joint portion 53. The second coil 70E covers a portion on the proximal side of the first core shaft 11 and a portion on the distal side of the second core shaft 12, and connects the first core shaft 11 and the second core shaft 12.

[0076] As described above, the configuration of the sensor-equipped medical device 1E can be modified in various ways. The sensor-equipped medical device 1E does not need to have the tube 80. In the sensor-equipped medical device 1E, the first core shaft 11 and the second core shaft 12 may be connected by the second coil 70E. The second coil 70E may be divided into two or more coils arranged side by side in the X-axis direction. In this case, the two or more coils may be made of different materials. The sensor-equipped medical device 1E of the sixth embodiment as described above can also achieve the same effects as the first embodiment.

[0077] 18 is an explanatory diagram illustrating the configuration of a sensor-equipped medical device 1F of a seventh embodiment. The sensor-equipped medical device 1F of the seventh embodiment includes a core shaft 10F instead of the first core shaft 11 and the second core shaft 12 in the configuration described in the first embodiment.

[0078] The core shaft 10F is a solid member having an elongated shape extending along the X-axis direction. The core shaft 10F has, in order from the distal end 111 to the proximal end 122, a first portion 115, a second portion 116, a third portion 117, a fourth portion 118F, a sixth portion 126, and a seventh portion 127. The configurations of the portions 115, 116, 117, 126, and 127, excluding the fourth portion 118F, are as described in the first embodiment. The fourth portion 118F of the core shaft 10F is a portion provided between the third portion 117 and the sixth portion 126. The fourth portion 118F is a generally cylindrical portion having a generally constant outer diameter.

[0079] As described above, the configuration of the sensor-equipped medical device 1F can be modified in various ways. The sensor-equipped medical device 1F may be configured to have only one core shaft 10F. In other words, the sensor-equipped medical device 1F may be configured so that there is no gap 13 between the first core shaft 11 and the second core shaft 12. The sensor-equipped medical device 1F of the seventh embodiment as described above can also achieve the same effects as the first embodiment. According to the sensor-equipped medical device 1F of the seventh embodiment, the absence of the gap 13 allows the rigidity of the sensor-equipped medical device 1F to be further improved.

[0080] Eighth Embodiment Figure 19 is a diagram showing an example of a cross section taken along line A-A in Figure 10 in the eighth embodiment. A medical device with sensor 1G of the eighth embodiment further includes an adhesive layer 90 in addition to the configuration described in the first embodiment. In the medical device with sensor 1G, the wire 30 is fixed to the first core shaft 11 by welding. An adhesive layer 90 is formed between the wire 30 and the first core shaft 11. The adhesive layer 90 fixes the wire 30 to the first core shaft 11. The adhesive layer 90 is formed by performing a heat treatment with the wire 30 wound around the first core shaft 11, whereby the adhesive layer for bonding the wires together melts toward the first core shaft 11 and then hardens. The axial range in which the adhesive layer 90 is formed is at least a part of the range in which the wire 30 is wound.

[0081] As described above, the configuration of the sensor-equipped medical device 1G can be modified in various ways. The sensor-equipped medical device 1G may have an adhesive layer 90. The adhesive layer 90 may be provided in one location within the area where the wiring 30 is wound, or in two or more locations. The sensor-equipped medical device 1G of the eighth embodiment as described above can also achieve the same effects as the first embodiment. According to the sensor-equipped medical device 1G of the eighth embodiment, the adhesive layer 90 can fix at least a portion of the wiring 30 to the first core shaft 11. The adhesive layer 90 is formed by dissolving an adhesive layer for bonding the wiring together toward the first core shaft 11 and then solidifying, so that the wiring 30 and the first core shaft 11 can be fixed without using a separate adhesive.

[0082] <Modifications of this embodiment> The present disclosure is not limited to the above-described embodiment, and can be implemented in various forms without departing from the gist thereof. For example, the following modifications are also possible.

[0083] [Variation 1] In the first to eighth embodiments, the configurations of the sensor-equipped medical devices 1, 1A-1G are illustrated. However, various modifications are possible to the configuration of the sensor-equipped medical device. For example, the sensor 20 is not limited to a sensor that measures the electrical resistance of bodily fluids such as blood flowing through a blood vessel. The sensor 20 may also be a sensor that measures blood pressure, i.e., intravascular pressure. The measured blood pressure can be used to derive the fractional flow reserve (FFR). The FFR is the pressure behind the stenosis relative to the pressure in front of the stenosis, and can be used as an indicator of the severity of the physiological stenosis. For example, the sensor 20 does not have to be formed using the sheet-like sensor sheet 24. The sensor 20 may be configured by fixing any number of sensor elements to the outer circumferential surface of the tubular member 22 using any method.

[0084] For example, in the medical device with sensor, at least a portion of the first coil 60, the second coil 70, the second coil 70E, the distal tube 70D, and the tube 80 may be covered with a resin coating. The entire medical device with sensor, except for the connector 40, may be covered with a resin coating. Either a hydrophilic resin or a hydrophobic resin can be used as the resin for the coating. For example, an inner coil may be provided inside the first coil 60.

[0085] For example, the first core shaft 11 and the second core shaft 12 may be arranged without a gap 13. In other words, the base end surface of the first core shaft 11 may be in contact with the base end surface of the second core shaft 12. For example, the first core shaft 11 does not have to pass through the sensor 20 in the X-axis direction. In this case, the tip end 111 of the first core shaft 11 may be fixed to the sensor 20 by the first joint portion 51.

[0086] For example, the base end surface of the first tube 41a and the tip end surface of the sixth tube 41f may be perpendicular to the X-axis direction, rather than inclined. For example, both end surfaces of the tubes 41b to 41e may be perpendicular to the X-axis direction, rather than inclined. For example, the seventh portion 127 of the second core shaft 12 may not protrude from the base end of the connector 40. For example, the second core shaft 12 may not penetrate the insulators 43a to 43e inside the connector 40. In this case, the base end 122 of the second core shaft 12 is located at the tip end of the connector 40. The third joint portion 53 joins the base end of the second core shaft 12 to the tip end of the connector 40.

[0087] [Variation 2] In the first to eighth embodiments, the configurations of the wiring 30, 30A, and 30B are illustrated. However, various modifications to the wiring configuration are possible. For example, the number of conductors 301a to 301e included in the wiring may be one, or any number of two or more. For example, the wiring does not have to be bundled. For example, the winding direction of the wiring and the winding direction of the second coil 70 may be the same.

[0088] 9 illustrates a configuration in which the inner covering portions 302a to 302e and the outer covering portion 303 are removed from the entire circumference of the conductors 301a to 301e. However, the inner covering portions 302a to 302e and the outer covering portion 303 may be removed from only a portion of the circumference of the conductors 301a to 301e.

[0089] For example, the wiring does not have to be fixed to the first core shaft 11 at the tip end 321 of the first roll portion 32. The wiring does not have to be fixed to the first core shaft 11 at the base end 341 of the third roll portion 34. The wiring may be fixed to the first core shaft 11 at a portion other than the tip end 321 and the base end 341. The number and positions of fixing points between the wiring and the first core shaft 11 may be determined arbitrarily.

[0090] [Modification 3] The configurations of the sensor-equipped medical devices 1, 1A-1G of the first to eighth embodiments and the configurations of Modifications 1 and 2 may be combined as appropriate. For example, the sensor-equipped medical device 1A of the second embodiment may be configured to include the wiring 30B described in the third embodiment. For example, a sensor-equipped medical device may be configured to include at least some of the wiring 30A described in the second embodiment, the wiring 30B described in the third embodiment, the first core shaft 11C described in the fourth embodiment, the distal tube 70D described in the fifth embodiment, the second coil 70E described in the sixth embodiment, the core shaft 10F described in the seventh embodiment, and the adhesive layer 90 described in the eighth embodiment.

[0091] This aspect has been described above based on embodiments and modifications. The above-described embodiments of the aspect are intended to facilitate understanding of this aspect and are not intended to limit this aspect. This aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents thereof are included in this aspect. If a technical feature is not described as essential in this specification, it may be deleted as appropriate.

Claims

1. A medical device with a sensor (1, 1A to 1G), comprising: a sensor (20); a core shaft (11, 11C); and a wiring (30, 30A, 30B) having a cross-sectional shape in which the thickness direction is smaller than the width direction, wherein conductive wires (301a to 301e) electrically connected to the sensor (20) are arranged inside, and within a predetermined range in the longitudinal direction of the core shaft (11, 11C), the wiring (30, 30A, 30B) is wound around the core shaft (11, 11C) in a state where the thickness direction continuously follows the radial direction of the core shaft (11, 11C).

2. The medical device with a sensor (1, 1A to 1B, 1D to 1G) according to claim 1, wherein the core shaft (11) has a tapered portion (116, 117) whose outer diameter becomes thinner from the proximal end to the distal end in at least a part of the predetermined range.

3. The medical device with a sensor (1, 1A to 1B, 1D to 1G) according to claim 2, wherein the wiring (30, 30A, 30B) is wound around the tapered portion (116, 117) of the core shaft (11).

4. The medical device with a sensor (1, 1A to 1C, 1E to 1G) according to any one of claims 1 to 3, further comprising a coil (60, 70) that covers at least a part of the core shaft (11, 11C) in the longitudinal direction of the core shaft (11, 11C).

5. The medical device with a sensor (1, 1A to 1C, 1E to 1G) according to claim 4, wherein the winding direction of the coil (70) and the winding direction of the wiring (30, 30A, 30B) are opposite.

6. The medical device with a sensor (1, 1A to 1E, 1G) according to any one of claims 1 to 5, wherein the core shaft is a first core shaft (11, 11C), and further includes a second core shaft (12) disposed closer to the proximal end than the first core shaft (11, 11C), and the second core shaft (12) is disposed with a gap (13) between the tip of the second core shaft (12) and the proximal end of the first core shaft (11, 11C). The medical device with a sensor (1, 1A to 1E, 1G).

7. The medical device with a sensor (1, 1A to 1D, 1G) according to claim 6, further comprising a tube (80) covering at least a part of the first core shaft (11, 11C) and at least a part of the second core shaft (12), and the tube (80) connecting the first core shaft (11, 11C) and the second core shaft (12). The medical device with a sensor (1, 1A to 1D, 1G).

8. The medical device with a sensor (1, 1A to 1G) according to any one of claims 1 to 7, wherein the conducting wire is a first conducting wire (301a), and the wiring (30, 30A, 30B) has a second conducting wire (301b) bundled with the first conducting wire (301a). The medical device with a sensor (1, 1A to 1G).

9. The medical device with a sensor (1, 1A to 1G) according to any one of claims 1 to 8, wherein the wiring (30, 30A, 30B) has a pair of opposing main surfaces and a pair of opposing side surfaces, and the wiring (30, 30A, 30B) is wound around the core shaft (11, 11C) with the first main surface of the pair of main surfaces continuously facing the outer peripheral surface of the core shaft (11, 11C). The medical device with a sensor (1, 1A to 1G).

10. The medical device with a sensor (1, 1A to 1G) according to any one of claims 1 to 9, wherein the wiring (30, 30A, 30B) is slidable relative to the core shaft (11, 11C) within at least a part of the predetermined range. The medical device with a sensor (1, 1A to 1G).

11. A medical device with a sensor (1, 1A to 1G) according to any one of claims 1 to 10, wherein the wiring (30, 30A, 30B) further has a covering portion (302a to 302e, 303) covering the outer peripheral surface of the conducting wire (301a to 301e).

12. A medical device with a sensor (1, 1A to 1G) according to any one of claims 1 to 11, wherein the core shaft (11, 11C) penetrates the sensor (20) in the long axis direction.

13. A medical device with a sensor (1G) according to any one of claims 1 to 12, further comprising an adhesive layer (90) that adheres the core shaft (11) and the wiring (30).

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