Medical device with sensor

Abstract

This medical device with a sensor comprises: a sensor; wiring that is electrically connected to the sensor; a conductive first tube that is positioned closer to the base end side than the sensor and is electrically connected to the wiring; a conductive second tube that is positioned closer to the base end side than the first tube and that is electrically connected to the wiring; and an insulator that is sandwiched between the first tube and the second tube and partially exposed to the outside, wherein the shape of the exposed portion in the case of being viewed from a first radial direction is different from the shape of the exposed portion in the case of being viewed from a second radial direction different from the first radial direction.

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 Documents 1 and 2 disclose devices having a sensor and a connector in which conductive and insulating portions are alternately arranged. Patent Document 3 discloses a multi-lumen catheter in which a thermocouple is inserted as a temperature sensor into the fourth lumen. Hereinafter, the insulating portion will also be referred to as an "insulator."

[0003] US Patent No. 9878142 Specification JP 2016-527963 A JP 2009-254423 A

[0004] In the devices described in Patent Documents 1 and 2, the hardness of the conductive part and the insulator are significantly different, so when connecting the connector to an external device, stress concentrates at the junction between the conductive part and the insulator, which may damage the insulator, which is less hard than the conductive part. Patent Document 3 does not take into consideration the structure of the connector at all.

[0005] The present disclosure has been made to solve at least some of the above-mentioned problems, and aims to suppress damage to the insulator 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 sensor; a wiring electrically connected to the sensor; a conductive first tube located proximal to the sensor and electrically connected to the wiring; a conductive second tube located proximal to the first tube and electrically connected to the wiring; and an insulator sandwiched between the first tube and the second tube, a portion of the insulator being exposed to the outside, the exposed portion having a different shape when viewed from a first radial direction than when viewed from a second radial direction different from the first radial direction.

[0008] According to this configuration, the shape of the exposed portion of the insulator when viewed from a first radial direction differs from the shape of the exposed portion when viewed from a second radial direction different from the first radial direction. In other words, the insulator is not a right cylinder. Therefore, even if bending occurs near the insulator when connecting the connector to an external device, stress is less likely to concentrate on the insulator. As a result, damage to the insulator can be suppressed.

[0009] (2) In the medical device with a sensor of the above aspect, the insulator may be an adhesive. With this configuration, the connector including the first and second tubes and the insulator can be easily manufactured.

[0010] (3) In the medical device with a sensor of the above aspect, the proximal end of the first tube may be located closer to the proximal end than the distal end of the second tube. With this configuration, stress on the insulator is more evenly distributed, thereby more effectively suppressing damage to the insulator.

[0011] (4) In the medical device with a sensor of the above aspect, an imaginary cylindrical surface formed by extending the outer circumferential surface of the first tube toward the proximal end may substantially coincide with the outer circumferential surface of the second tube. With this configuration, the first and second tubes can be configured to have the appearance of a single tube.

[0012] (5) The medical device with a sensor of the above embodiment may further include a core shaft that penetrates the insulator. This configuration improves the strength of the portion of the connector where the insulator is disposed. As a result, damage to the insulator is further suppressed, thereby improving safety.

[0013] (6) In the medical device with sensor of the above aspect, at least one of the proximal end surface of the first tube and the distal end surface of the second tube may include a portion that is inclined with respect to the longitudinal axis direction of the medical device with sensor. With this configuration, even if bending occurs near the insulator when connecting the connector to an external device, stress on the insulator is more evenly distributed, and damage to the insulator is more effectively suppressed.

[0014] (7) In the medical device with sensor of the above aspect, at least a portion of the base end surface of the first tube may be substantially parallel to at least a portion of the tip end surface of the second tube. With this configuration, there is no portion in the longitudinal direction that is made up solely of the insulator. Therefore, stress on the insulator is more evenly distributed, and damage to the insulator is more effectively suppressed.

[0015] (8) In the medical device with sensor of the above aspect, at least one of the first tube and the second tube may be joined to the insulator at an inner circumferential surface thereof. With this configuration, the joining strength between the first and second tubes and the insulator can be improved, thereby providing a connector that is less likely to break.

[0016] (9) In the medical device with a sensor of the above aspect, the insulator sandwiched between the first tube and the second tube may be a first insulator, and may further include: a conductive third tube located proximal to the second tube and electrically connected to the wiring; and a second insulator sandwiched between the second tube and the third tube and partially exposed to the outside, the exposed portion having a shape different from that of the exposed portion when viewed from the first radial direction. With this configuration, the first and second insulators are not right cylindrical, thereby preventing damage to the first and second insulators.

[0017] (10) In the medical device with sensor of the above aspect, the shape of the exposed portion of the first insulator and the shape of the exposed portion of the second insulator when viewed from the first radial direction may be substantially the same. With this configuration, the medical device with sensor that can suppress damage to the insulators can be easily manufactured.

[0018] The present disclosure can be realized in various forms, such as a medical device with a sensor, a connector component of a medical device with a sensor, a catheter including a medical device with a sensor, and a method of manufacturing these.

[0019] 10 is 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 view showing the configuration of a tubular member. An explanatory view showing the configuration of a sensor sheet. An explanatory view for explaining a method of manufacturing a sensor. An explanatory view showing the configuration of wiring. An enlarged view of the proximal end side of a medical device with a sensor. An explanatory view illustrating the configuration of a connector. An explanatory view illustrating the configuration of the proximal end part of wiring. A cross-sectional view of the connector taken along line A1-A1 of FIG. 8. A cross-sectional view of the connector taken along line A2-A2 of FIG. 8. A longitudinal cross-sectional view of the connector taken along line B-B of FIG. 10. A view explaining the relationship between a first tube and a second tube. An external view of the connector seen from a first radial direction D1. An external view of the connector seen from a second radial direction D2. An external view of the connector of a second embodiment seen from the second radial direction D2. An external view of the connector of a third embodiment seen from the second radial direction D2. An enlarged view of the proximal end side of a medical device with a sensor of a fourth embodiment. A longitudinal cross-sectional view of a connector of a fifth embodiment. An enlarged view of the proximal end side of a medical device with a sensor of a sixth embodiment.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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 with the largest outer diameter in the first core shaft 11 and has a substantially cylindrical shape with a substantially constant outer diameter. The outer diameters, lengths in the axial direction O, and cross-sectional shapes of the first portion 115, second portion 116, third portion 117, and fourth portion 118 can be determined arbitrarily.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] The tube 80 is a tubular body having 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. The tube 80 can be formed using, for example, at least one of nickel titanium and a nickel titanium alloy.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 6 is an explanatory diagram showing the configuration of the wiring 30. The wiring 30 is a connection line that electrically connects the sensor 20 and the connector 40. As shown in FIG. 1, a tip end 31 of the wiring 30 is electrically connected to the sensor 20. A 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 covering portions 302a to 302e, and an outer covering portion 303.

[0038] 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.

[0039] In the wiring 30, the direction in which the conductive wires 301a to 301e and the inner covering 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 side 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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 .

[0047] FIG. 10 is a cross-sectional view of the connector 40 taken along line A1-A1 in FIG. 8 . The second core shaft 12 and the wiring 30 are disposed inside the first tube 41a of the connector 40. The outer circumferential surface of the second core shaft 12 is covered with an insulating second insulating tube 16. The inner covering portion 302a and the outer covering portion 303 of the wiring 30 are partially peeled off, exposing the conductor 301a. The inside of the first tube 41a is filled with a conductive first conductor 42a. The first conductor 42a electrically connects the first tube 41a and the conductor 301a and secures the second core shaft 12 disposed inside the first tube 41a to the wiring 30. The first conductor 42a can be formed, for example, from a conductive adhesive containing metal powder. The first conductor 42a may also be formed from a conductive solder paste.

[0048] FIG. 11 is a cross-sectional view of the connector 40 taken along line A2-A2 in FIG. 8. At the position of the connector 40 where the first insulator 43a is provided, the second core shaft 12 and the wiring 30 are disposed inside the second tube 41b. The outer circumferential surface of the second core shaft 12 is covered with an insulating second insulating tube 16. No exposed portions of the conductors 301a-301e are present on the wiring 30. The inside of the second tube 41b is filled with an insulating first insulator 43a. The first insulator 43a electrically insulates the second tube 41b from the first tube 41a and secures the second core shaft 12 and the wiring 30 disposed inside the second tube 41b. The distal end surface of the second tube 41b is inclined with respect to the X-axis direction. Therefore, in a cross-section including the first insulator 43a, the second tube 41b has a circular shape with a circumferentially cut-out portion. The cutout portion of the second tube 41b is filled with a first insulator 43a, which is exposed to the outside.

[0049] FIG. 12 is a longitudinal cross-sectional view of the connector 40 taken along line B-B in FIG. 10. FIG. 13 illustrates the relationship between the first tube 41a and the second tube 41b. For ease of explanation, the first insulator 43a is not shown in FIG. 13. In FIG. 13, an imaginary cylindrical surface VC, which is an extension of the outer circumferential surface of the first tube 41a toward the base end, is shown by a two-dot chain line. The imaginary cylindrical surface VC coincides with the outer circumferential surface of the second tube 41b. "Coincidence" includes a general coincidence, allowing for slight differences due to manufacturing errors, etc. In other words, the first tube 41a and the second tube 41b are arranged with their respective outer circumferential surfaces coincident with the imaginary cylindrical surface VC, as if they were a single tube. The first tube 41a has a double ellipsoidal surface 412a at its base end, located toward the second tube 41b. The double ellipsoidal surface is formed by the outer periphery and inner periphery of the tube. The double ellipsoidal surface is a cross section of the tube wall. As shown in Figure 13, the double ellipsoid surface 412a is the base end surface of the first tube 41a. The entire double ellipsoid surface 412a is inclined with respect to the long axis direction of the sensor-equipped medical device 1. The second tube 41b has a double ellipsoid surface 411b at its tip located on the first tube 41a side. As shown in Figure 13, the double ellipsoid surface 411b is the tip end surface of the second tube 41b. The entire double ellipsoid surface 411b is inclined with respect to the long axis direction of the sensor-equipped medical device 1. The double ellipsoid surface 412a of the first tube 41a and the double ellipsoid surface 411b of the second tube 41b are parallel. In other words, the double ellipsoid surface 412a of the first tube 41a and the double ellipsoid surface 411b of the second tube 41b are inclined in the same direction at the same angle. The base end 41ap of the first tube 41a is located closer to the base end than the tip end 41bd of the second tube 41b.

[0050] As shown in FIG. 12 , a first insulator 43a is disposed between the double ellipsoidal surface 412a and the double ellipsoidal surface 411b. In other words, the first tube 41a is joined to the first insulator 43a at the double ellipsoidal surface 412a. The second tube 41b is joined to the first insulator 43a at the double ellipsoidal surface 411b. The double ellipsoidal surface 412a and the double ellipsoidal surface 411b are parallel. Therefore, the joint surface between the first tube 41a and the first insulator 43a is parallel to the joint surface between the second tube 41b and the first insulator 43a. At the base end of the first tube 41a, the first insulator 43a is also disposed on the inner circumferential surface 41ai of the first tube 41a. At the tip end of the second tube 41b, the first insulator 43a is also disposed on the inner circumferential surface 41bi of the second tube 41b. The second core shaft 12 passes through the first insulator 43a. The wiring 30 passes through the first insulator 43a.

[0051] FIG. 14 is an external view of the connector 40 as viewed from the first radial direction D1. FIG. 15 is an external view of the connector 40 as viewed from the second radial direction D2. As shown in FIG. 10, the first radial direction D1 is a direction from the outside of the sensor-equipped medical device 1 toward the center O along the Z-axis. The second radial direction D2 is a direction from the outside of the sensor-equipped medical device 1 toward the center O along the Y-axis. The first radial direction D1 and the second main surface MF2 shown in FIG. 10 are merely examples. The first radial direction D1 and the second radial direction D2 may be determined arbitrarily as long as they are different from each other. As shown in FIG. 14, the shape of the exposed portion of the first insulator 43a as viewed from the first radial direction D1 is approximately C-shaped. The shape of the exposed portion of the first insulator 43a as viewed from a certain radial direction is a two-dimensional shape obtained by projecting the outline of the portion of the exposed portion of the first insulator 43a that is visible from that radial direction onto a plane perpendicular to that radial direction. As shown in Fig. 15 , the shape of the exposed portion of the first insulator 43a when viewed from the second radial direction D2 is a parallelogram. Thus, the shape of the exposed portion of the first insulator 43a when viewed from the first radial direction D1 differs from the shape of the exposed portion of the first insulator 43a when viewed from the second radial direction D2. Figs. 14 and 15 illustrate the shapes of the exposed portion of the first insulator 43a when viewed from the first radial direction D1 and the second radial direction D2 illustrated in Fig. 10 . The shapes of the exposed portion of the first insulator 43a when viewed from different radial directions are not limited to the first and second radial directions D1 and D2 illustrated in Fig. 10 .

[0052] 10 to 15 have been described with respect to the first tube 41a and the second tube 41b joined by the first insulator 43a. The second tube 41b and the third tube 41c joined by the second insulator 43b have a similar configuration. The third tube 41c and the fourth tube 41d joined by the third insulator 43c have a similar configuration. The fourth tube 41d and the fifth tube 41e joined by the fourth insulator 43d have a similar configuration. The fifth tube 41e and the sixth tube 41f joined by the fifth insulator 43e have a similar configuration, except that the wiring 30 is not arranged inside the sixth tube 41f, and instead the sixth portion 126 of the second core shaft 12 is arranged therein. The sixth portion 126 and the seventh portion 127 of the second core shaft 12 are not covered by the second insulating tube 16. Therefore, inside the sixth tube 41f, the sixth tube 41f and the second core shaft 12 are electrically connected by a conductor arranged inside the sixth tube 41f.

[0053] The shape of the exposed portion of the second insulator 43b as viewed from the first radial direction D1 is different from the shape of the exposed portion of the second insulator 43b as viewed from the second radial direction D2. The shape of the exposed portion of the third insulator 43c as viewed from the first radial direction D1 is different from the shape of the exposed portion of the third insulator 43c as viewed from the second radial direction D2. The shape of the exposed portion of the fourth insulator 43d as viewed from the first radial direction D1 is different from the shape of the exposed portion of the fourth insulator 43d as viewed from the second radial direction D2. The shape of the exposed portion of the fifth insulator 43e as viewed from the first radial direction D1 is different from the shape of the exposed portion of the fifth insulator 43e as viewed from the second radial direction D2. As shown in FIG. 8 , the shapes of the exposed portions as viewed from the first radial direction D1 are all the same for the first to fifth insulators 43a to 43e. The shapes of the exposed portions as viewed from the second radial direction D2 are all the same for the first to fifth insulators 43a to 43e.

[0054] When an operator pushes the connector 40 into a terminal receptacle of an external device to connect the connector 40, a force acts on the connector 40 in the X-axis direction, causing the connector 40 to bend. In the connector 40, the resin insulators 43a-43e have lower rigidity than the metal tubes 41a-41f. Therefore, when connecting the connector 40 to an external device, bending stress is likely to act on the insulators 43a-43e, which have relatively low rigidity. According to the sensor-equipped medical device 1 of the first embodiment, the shape of the exposed portions of the insulators 43a-43e when viewed from the first radial direction D1 differs from the shape of the exposed portions when viewed from a second radial direction D2 different from the first radial direction D1. In other words, the insulators 43a-43e are not right cylindrical. Therefore, even if bending acts near the insulators 43a-43e when connecting the connector 40 to an external device, stress is less likely to concentrate on the insulators 43a-43e. As a result, the medical device with sensor 1 can prevent damage to the insulators 43a to 43e.

[0055] According to the medical device with sensor 1 of the first embodiment, the insulators 43a-43e are formed from an insulating adhesive, so the connector 40 including the first tube 41a, the second tube 41b, and the first insulator 43a can be easily manufactured. The medical device with sensor 1 of the first embodiment includes a second core shaft 12 that penetrates the insulators 43a-43e. This improves the strength of the portion of the connector 40 where the insulators 43a-43e are located. As a result, damage to the insulators 43a-43e is further suppressed, improving the safety of the procedure.

[0056] According to the sensor-equipped medical device 1 of the first embodiment, the base end 41ap of the first tube 41a is located closer to the base end than the tip 41bd of the second tube 41b. This more evenly distributes stress on the first insulator 43a, more effectively suppressing damage to the first insulator 43a. According to the sensor-equipped medical device 1 of the first embodiment, the imaginary cylindrical surface VC obtained by extending the outer circumferential surface of the first tube 41a toward the base end substantially coincides with the outer circumferential surface of the second tube 41b. This allows the first tube 41a and the second tube 41b to appear as a single tube.

[0057] According to the sensor-equipped medical device 1 of the first embodiment, at least one of the double ellipsoidal surface 412a of the first tube 41a and the double ellipsoidal surface 411b of the second tube 41b includes a portion that is inclined with respect to the longitudinal axis direction of the sensor-equipped medical device 1. Therefore, even if bending occurs near the first insulator 43a when connecting the connector 40 to an external device, stress on the first insulator 43a is more evenly distributed, and damage to the first insulator 43a is more effectively suppressed. This also applies to the insulators 43b to 43e.

[0058] According to the sensor-equipped medical device 1 of the first embodiment, at least a portion of the joint surface between the first tube 41a and the first insulator 43a is substantially parallel to at least a portion of the joint surface between the second tube 41b and the first insulator 43a. Therefore, there is no portion in the longitudinal direction of the sensor-equipped medical device 1 that is composed solely of the first tube 41a. In other words, in any cross section of the sensor-equipped medical device 1 along the longitudinal direction, the metal tubes 41a and 41b are included in at least a portion. Therefore, stress on the first insulator 43a is more evenly distributed, and damage to the first insulator 43a is more effectively suppressed. This also applies to the insulators 43b to 43e.

[0059] According to the first embodiment of the medical device with sensor 1, at least one of the first tube 41a and the second tube 41b is joined to the first insulator 43a at the inner circumferential surfaces 41ai, 41bi. This improves the joining strength between the first tube 41a and the second tube 41b and the first insulator 43a, thereby providing a connector 40 that is less susceptible to breakage. This also applies to the insulators 43b to 43e.

[0060] According to the sensor-equipped medical device 1 of the first embodiment, the second insulator 43b is sandwiched between the second tube 41b and the third tube 41c and is partially exposed to the outside, and the shape of the exposed portion when viewed from the first radial direction D1 is different from the shape of the exposed portion when viewed from the second radial direction D2. This makes it possible to suppress damage to the second insulator 43b. According to the sensor-equipped medical device 1 of the first embodiment, the shape of the exposed portion of the first insulator 43a when viewed from the first radial direction D1 is approximately the same as the shape of the exposed portion of the second insulator 43b. This makes it possible to easily manufacture the sensor-equipped medical device 1, which is capable of suppressing damage to the insulators 43a to 43e.

[0061] 16 is an external view of a connector 40A of a second embodiment as seen from the second radial direction D2. A medical device with sensor 1A of the second embodiment includes a connector 40A instead of the connector 40 in the configuration described in the first embodiment. The connector 40A includes a second tube 41bA instead of the second tube 41b and a first insulator 43aA instead of the first insulator 43a in the configuration described in the first embodiment.

[0062] The second tube 41bA has a double ellipsoidal surface 411bA at its tip located on the first tube 41a side. A first portion PA1 of the double ellipsoidal surface 411bA is inclined with respect to the major axis direction of the sensor-equipped medical device 1A. A second portion PA2 of the double ellipsoidal surface 411bA is perpendicular to the major axis direction of the sensor-equipped medical device 1A and is not inclined. Therefore, the double ellipsoidal surface 412a and the double ellipsoidal surface 411bA are parallel at the first portion PA1 of the double ellipsoidal surface 411bA. The double ellipsoidal surface 412a and the double ellipsoidal surface 411bA are not parallel at the second portion PA2 of the double ellipsoidal surface 411bA. A first insulator 43aA is disposed between the double ellipsoidal surface 412a and the double ellipsoidal surface 411bA, joining the first tube 41a and the second tube 41bA.

[0063] As described above, the configuration of the connector 40A can be modified in various ways. The double ellipsoidal surface 411bA of the second tube 41bA may include a second portion PA2 that is not inclined with respect to the longitudinal axis direction of the sensor-equipped medical device 1A. The position and size of the second portion PA2 may be determined arbitrarily. Similarly, the first tube 41a and the third tube 41c to the sixth tube 41f may also be configured to include a first portion PA1 and a second portion PA2. The sensor-equipped medical device 1A of the second embodiment described above can also achieve the same effects as the first embodiment.

[0064] 17 is an external view of a connector 40B of a third embodiment as seen from the second radial direction D2. A medical device with sensor 1B of the third embodiment includes a connector 40B instead of the connector 40 in the configuration described in the first embodiment. The connector 40B includes a second tube 41bB instead of the second tube 41b and a first insulator 43aB instead of the first insulator 43a in the configuration described in the first embodiment.

[0065] The second tube 41bB has a double circular surface 411bB at its tip located on the first tube 41a side. The double circular surface is formed by the outer and inner circumferences of the tube. The entire double circular surface 411bB is perpendicular to the longitudinal axis direction of the sensor-equipped medical device 1B and is not inclined. Therefore, the double elliptical surface 412a and the double circular surface 411bB are not parallel. The joint surface between the first tube 41a and the first insulator 43aB in the double elliptical surface 412a is not parallel to the joint surface between the second tube 41bB and the first insulator 43aB in the double circular surface 411bB. The base end 41ap of the first tube 41a is located more distal than the tip 41bd of the second tube 41bB. The first insulator 43aB is disposed between the double elliptical surface 412a and the double circular surface 411bB, joining the first tube 41a and the second tube 41bB. The first insulator 43aB has a trapezoidal shape when viewed from the second radial direction D2.

[0066] As described above, the configuration of the connector 40B can be modified in various ways. The end face of the second tube 41bB may be a double circular surface 411bB that is not inclined with respect to the longitudinal axis direction of the sensor-equipped medical device 1B. Similarly, some end faces of the first tube 41a and the third tube 41c to the sixth tube 41f may also be double circular surfaces that are not inclined with respect to the longitudinal axis direction of the sensor-equipped medical device 1B. The sensor-equipped medical device 1B of the third embodiment described above can also achieve the same effects as the first embodiment.

[0067] 18 is an enlarged view of the proximal end side of a medical device with sensor 1C according to a fourth embodiment. The medical device with sensor 1C according to the fourth embodiment has the same configuration as that described in the first embodiment, but includes a connector 40C instead of the connector 40. The connector 40C includes a second tube 41bC instead of the second tube 41b, a fourth tube 41dC instead of the fourth tube 41d, a fifth tube 41eC instead of the fifth tube 41e, and a sixth tube 41fC instead of the sixth tube 41f.

[0068] The second tube 41bC has the same outer diameter as the first tube 41a. The second tube 41bC is positioned circumferentially offset relative to the first tube 41a. An imaginary cylindrical surface formed by extending the outer circumferential surface of the first tube 41a toward the proximal end does not coincide with the outer circumferential surface of the second tube 41bC. The fourth tube 41dC has a larger outer diameter than the third tube 41c. The fifth tube 41eC has a larger outer diameter than the fourth tube 41dC. The sixth tube 41fC has a larger outer diameter than the fifth tube 41eC. An imaginary cylindrical surface formed by extending the outer circumferential surface of the first tube 41a toward the proximal end does not coincide with the outer circumferential surface of the fourth tube 41dC. An imaginary cylindrical surface formed by extending the outer circumferential surface of the first tube 41a toward the proximal end does not coincide with the outer circumferential surface of the fifth tube 41eC. An imaginary cylindrical surface formed by extending the outer circumferential surface of the first tube 41a toward the proximal end does not coincide with the outer circumferential surface of the sixth tube 41fC.

[0069] As described above, the configuration of the connector 40C can be modified in various ways. The imaginary cylindrical surface obtained by extending the outer circumferential surface of the first tube 41a toward the base end does not have to coincide with the outer circumferential surface of the second tube 41bC. As shown in FIG. 18, the outer diameter of at least some of the tubes 41a to 41f may gradually increase from the distal end to the proximal end. Contrary to FIG. 18, the outer diameter of at least some of the tubes 41a to 41f may gradually decrease from the distal end to the proximal end. The medical device with sensor 1C of the fourth embodiment described above can also achieve the same effects as the first embodiment.

[0070] Fifth Embodiment Fig. 19 is a longitudinal cross-sectional view of a connector 40D of a fifth embodiment. A medical device with sensor 1D of the fifth embodiment includes a connector 40D instead of the connector 40 in the configuration described in the first embodiment. The connector 40D includes a first insulator 43aD instead of the first insulator 43a in the configuration described in the first embodiment. The first insulator 43aD is disposed only between the opposing first tube 41a and second tube 41b, and is not disposed on the inner circumferential surface 41ai of the first tube 41a or the inner circumferential surface 41bi of the second tube 41b. In the illustrated example, the portion of the inner circumferential surface 41ai of the first tube 41a where the first conductor 42a is not disposed is hollow. The portion of the inner circumferential surface 41bi of the second tube 41b where the second conductor 42b is not disposed is hollow.

[0071] As described above, the configuration of the connector 40D can be modified in various ways. In the connector 40D, the first insulator 43aD does not have to be disposed on the inner circumferential surface 41ai of the first tube 41a or the inner circumferential surface 41bi of the second tube 41b. Similarly, the second insulator 43b to the fifth insulator 43e may be disposed only between adjacent tubes, and not on the inner circumferential surfaces of the tubes. The medical device with sensor 1D of the fifth embodiment described above can also achieve the same effects as the first embodiment.

[0072] 20 is an enlarged view of the proximal end side of a sensor-equipped medical device 1E of a sixth embodiment. The sensor-equipped medical device 1E of the sixth embodiment has a connector 40E instead of the connector 40 in the configuration described in the first embodiment. The connector 40E does not have the third tube 41c to the sixth tube 41f and the second insulators 43b to the fifth insulators 43e described in the first embodiment. The connector 40E only has the first tube 41a, the second tube 41b, the first insulator 43a, the first conductor 42a, and the second conductor 42b.

[0073] As described above, the configuration of the connector 40E can be modified in various ways. The number of conductive tubes included in the connector 40E may be two. The number of conductive tubes included in the connector 40E can be any number equal to or greater than two, and may be three or ten. The number of insulators included in the connector 40E is the number of conductive tubes minus one. The medical device with sensor 1E of the sixth embodiment as described above can also achieve the same effects as the first embodiment.

[0074] <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.

[0075] [Variation 1] In the first to sixth embodiments, the configurations of the sensor-equipped medical devices 1, 1A to 1E 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 may be used to derive the fractional flow reserve (FFR). The FFR is the pressure behind the stenosis relative to the pressure ahead 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.

[0076] For example, in the medical device with sensor, at least a portion of the first coil 60, the second coil 70, and the tube 80 may be covered with a resin coating. In the medical device with sensor, the entire device 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.

[0077] For example, the first core shaft 11 and the second core shaft 12 may be arranged without leaving the 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, a single core shaft may be used instead of the first core shaft 11 and the second core shaft 12. In this case, the tube 80 may be omitted.

[0078] For example, an inner coil body may be provided inside the first coil 60. For example, a tube may be used instead of the second coil 70. The tube may be a flexible resin tube or a metal tube with slits. For example, a coil may be used instead of the tube 80.

[0079] For example, the wiring 30 does not have to be bundled. In other words, the outer covering portion 303 of the wiring 30 may be omitted. The wiring 30 may be bundled by a bundling member different from the outer covering portion 303. A portion of the wiring 30 may be bundled, and the remaining portion may not be bundled. The number of conductive wires 301a to 301e included in the wiring 30 does not have to be five. The length T30 of the wiring 30 in the thickness direction does not have to be smaller than the length W30 of the wiring 30 in the width direction. The length T30 of the wiring 30 in the thickness direction may be the same as the length W30 of the wiring 30 in the width direction.

[0080] [Variation 2] In the first to sixth embodiments, the configurations of the connectors 40, 40A to 40E are illustrated. However, various modifications to the connector configuration are possible. For example, the shape of the exposed portion of the first insulator 43a as viewed from the first radial direction D1 shown in FIG. 14 and the shape of the exposed portion of the first insulator 43a as viewed from the second radial direction D2 shown in FIG. 15 are merely examples. The shape of the exposed portion of the first insulator 43a as viewed from the first radial direction D1 and the shape of the exposed portion as viewed from the second radial direction D2 can be any shape as long as they are different from each other.

[0081] 10 illustrates a configuration in which the inner covering portion 302a and the outer covering portion 303 are removed from the entire circumference of the conductor 301a. However, the inner covering portion 302a and the outer covering portion 303 may be removed only from a portion of the circumferential direction of the conductor 301a. This also applies to the conductors 301b to 301e.

[0082] For example, FIG. 10 illustrates a configuration in which the first conductor 42a fills the entire inside of the first tube 41a. However, the first conductor 42a may be disposed only partially inside the first tube 41a. This also applies to the conductors disposed inside the second tube 41b to the sixth tube 41f. For example, FIGS. 11 and 12 illustrate a configuration in which the first insulator 43a fills the entire inside of the first tube 41a and the entire inside of the second tube 41b. However, the first insulator 43a may be disposed only partially inside the first tube 41a. Alternatively, the first insulator 43a may be disposed only partially inside the second tube 41b. This also applies to the second insulators 43b to the fifth insulators 43e.

[0083] 12 illustrates a configuration in which the second core shaft 12 penetrates the insulators 43a to 43e inside the connector 40. However, the second core shaft 12 does not have to penetrate the insulators 43a to 43e. In this case, the base end 122 of the second core shaft 12 is located at the tip of the connector 40. The third joint portion 53 joins the base end of the second core shaft 12 and the tip of the connector 40.

[0084] [Modification 3] The configurations of the sensor-equipped medical devices 1, 1A to 1E of the first to sixth embodiments and the configurations of the modifications 1 and 2 may be appropriately combined. For example, a connector may be configured that combines at least some of the features of the connector 40A described in the second embodiment, the connector 40B described in the third embodiment, the connector 40C described in the fourth embodiment, the connector 40D described in the fifth embodiment, and the connector 40E described in the sixth embodiment.

[0085] 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 (1, 1A - 1E) with a sensor, comprising: a sensor (20); a wiring (30) electrically connected to the sensor (20); a conductive first tube (41a) located on the proximal side of the sensor (20) and electrically connected to the wiring (30); a conductive second tube (41b, 41bA - 41bC) located on the proximal side of the first tube (41a) and electrically connected to the wiring (30); and an insulator (43a, 43aA, 43aB, 43aD) sandwiched between the first tube (41a) and the second tube (41b, 41bA - 41bC) with a part thereof exposed to the outside, wherein the shape of the exposed part when viewed from a first radial direction is different from the shape of the exposed part when viewed from a second radial direction different from the first radial direction.

2. The medical device (1, 1A - 1E) with a sensor according to claim 1, wherein the insulator (43a, 43aA, 43aB, 43aD) is an adhesive.

3. The medical device (1, 1A, 1C - 1E) with a sensor according to claim 1 or claim 2, wherein the proximal end of the first tube (41a) is located on the proximal side of the distal end of the second tube (41b, 41bA, 41bC).

4. The medical device (1, 1A - 1B, 1D - 1E) with a sensor according to any one of claims 1 to 3, wherein a virtual cylindrical surface extending the outer peripheral surface of the first tube (41a) toward the proximal side substantially coincides with the outer peripheral surface of the second tube (41b, 41bA - 41bB).

5. The medical device (1, 1A - 1E) with a sensor according to any one of claims 1 to 4, further comprising a core shaft (12) passing through the insulator (43a, 43aA, 43aB, 43aD).

6. A medical device with a sensor (1, 1A to 1E) according to any one of claims 1 to 5, wherein at least one of the proximal end face (412a) of the first tube (41a) and the distal end faces (411b, 411bA, 411bB) of the second tubes (41b, 41bA to 41bC) includes a portion inclined with respect to the longitudinal axis direction of the medical device with a sensor (1, 1A to 1E).

7. A medical device with a sensor (1, 1A, 1C to 1E) according to any one of claims 1 to 6, wherein at least a part of the proximal end face (412a) of the first tube (41a) is substantially parallel to at least a part of the distal end faces (411b, 411bA) of the second tubes (41b, 41bA, 41bC).

8. A medical device with a sensor (1, 1A to 1C, 1E) according to any one of claims 1 to 7, wherein at least one of the first tube (41a) and the second tubes (41b, 41bA to 41bC) is joined to the insulator (43a, 43aA, 43aB) on the inner peripheral surface.

9. A medical device with a sensor (1, 1A to 1D) according to any one of claims 1 to 8, wherein the insulator sandwiched between the first tube (41a) and the second tubes (41b, 41bA to 41bC) is a first insulator (43a, 43aA, 43aB, 43aD), and further includes a conductive third tube (41c) located on the proximal side of the second tubes (41b, 41bA to 41bC) and electrically connected to the wiring (30), and a second insulator (43b) sandwiched between the second tubes (41b, 41bA to 41bC) and the third tube (41c), with a part of the second insulator (43b) exposed to the outside, and the shape of the exposed part when viewed from the first radial direction is different from the shape of the exposed part when viewed from the second radial direction.

10. A medical device (1, 1A to 1D) with a sensor according to claim 9, wherein the shape of the exposed portion of the first insulator (43a, 43aA, 43aB, 43aD) and the shape of the exposed portion of the second insulator (43b) are substantially the same when viewed from the first radial direction. The medical device (1, 1A to 1D) with a sensor.

Images