Sensored guidewire

Abstract

A sensor-equipped guide wire (1) comprises a core wire (10), a sensor (20) disposed in a first section (S1) located in a front-end portion of the core wire (10), an electrode disposed in a second section (S2) located in a base end portion of the core wire (10), and a cable having a first lead and a second lead extending along the core wire (10) to the base end portion of the core wire. The cable is electrically connected to a wiring line of the sensor (20) in the first section and is electrically connected to the electrode in the second section (S2). When a position between the base end of the first section (S1) and the front-end of the second section (S2) is defined as an intermediate position (MP), the first lead and the second lead are not integrated and are movable relative to each other where the cable (30) is disposed between the base end of the first section. The first lead and the second lead are integrated where the cable (30) is disposed between the intermediate position (MP) and the distal end of the second section.

Description

[Technical Field]

[0001] The present invention relates to a guidewire with a sensor. [Background technology]

[0002] Among guidewires used to guide catheters and the like inserted into biological lumens such as blood vessels, there are sensor-equipped guidewires with sensors attached to their distal ends. For example, Patent Document 1 discloses a sensor-equipped guidewire in which wiring for transmitting an output signal from a sensor is wound around a core wire. Patent Document 2 also discloses a sensor-equipped guidewire in which such wiring is connected to two lead wires that are part of the sensor and extends toward the proximal end. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2018-516623 [Patent Document 2] Special Publication No. 2014-507197 Summary of the Invention [Problem to be solved by the invention]

[0004] The sensor-equipped guidewires disclosed in Patent Documents 1 and 2 each include two or more wires. The configuration of such wiring can affect the ease of handling of the sensor-equipped guidewire. For example, a configuration in which two or more wires are integrated at the distal end of the guidewire reduces tangling of the wires, but reduces the flexibility of the guidewire compared to a configuration in which two or more wires are not integrated, thereby reducing the efficiency of insertion of the guidewire to the target site. However, Patent Documents 1 and 2 do not consider at all the influence of the wiring configuration on the ease of handling of the sensor-equipped guidewire, and therefore there is room for improvement in the wiring configuration of the sensor-equipped guidewire.

[0005] The present invention has been made to solve at least part of the above-mentioned problems, and aims to provide a technique for improving the ease of handling of a sensor-equipped guide wire. [Means for solving the problem]

[0006] The present invention 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 invention, there is provided a guidewire with a sensor, the guidewire with a sensor comprising a core wire, a sensor disposed in a first section located at the distal end of the core wire, an electrode disposed in a second section located at the proximal end of the core wire, and a cable having a first lead wire and a second lead wire extending along the core wire to the proximal end of the core wire, the cable being electrically connected to the wiring of the sensor in the first section and to the electrode in the second section, and when an arbitrary position between the proximal end of the first section and the distal end of the second section is defined as an intermediate position, the first lead wire and the second lead wire in the cable disposed between the proximal end of the first section and the intermediate position are not integrated and are relatively movable, while the first lead wire and the second lead wire in the cable disposed between the intermediate position and the distal end of the second section are integrated.

[0008] According to this configuration, in the cable arranged between the base end of the first section and the intermediate position, the first lead wire and the second lead wire are not integrated and are capable of relative movement. Therefore, between the base end of the first section and the intermediate position, the first lead wire and the second lead wire, which are wiring, can move freely without following each other's movement, thereby ensuring flexibility at the distal end side of the guidewire. Also, according to this configuration, in the cable arranged between the intermediate position and the distal end of the second section, the first lead wire and the second lead wire are integrated. Therefore, entanglement of the first lead wire and the second lead wire between the intermediate position and the distal end of the second section can be prevented, ensuring operability at the proximal end side of the guidewire from the intermediate position. Therefore, according to this configuration, flexibility at the distal end side and operability at the proximal end side can both be achieved, thereby providing a sensor-equipped guidewire with improved ease of handling.

[0009] (2) In the sensor-equipped guide wire of the above-described form, a flexible tubular member may further be provided surrounding the core wire and the cable, and in at least a portion of the cable arranged inside the tubular member, the first lead wire and the second lead wire may not be integrated and may be capable of relative movement. With this configuration, the flexible portion of the cable where the first lead wire and the second lead wire are not integrated is covered with a flexible tubular member, thereby providing a sensor-equipped guide wire with ensured flexibility at the tip end.

[0010] (3) In the sensor-equipped guidewire of the above aspect, the intermediate position may be located closer to the proximal end than the proximal end of the tubular member. According to this configuration, it is possible to provide a sensor-equipped guide wire that ensures flexibility from the proximal end of the tubular member to the proximal end side.

[0011] (4) In the sensor-equipped guide wire of the above aspect, the cable may be joined to the core wire at the intermediate position. This configuration can prevent the integrated first and second lead wires located closer to the base end than the intermediate position from being pulled apart by the unintegrated first and second lead wires located closer to the tip end than the intermediate position. In other words, it is possible to maintain, with the intermediate position as the boundary, an area where the first and second lead wires are not integrated and an area where the first and second lead wires are integrated.

[0012] (5) In the sensor-equipped guidewire of the above aspect, the length of the first lead wire and the length of the second lead wire may be equal between the base end of the first section and the intermediate position. For example, if the length of the first lead wire is longer than the length of the second lead wire between the base end and the intermediate position of the first section, the length of the first lead wire corresponds to the length of the second lead wire plus the excess length. The longer this excess length, the higher the possibility that the first lead wire will become entangled with the second lead wire or the core wire. Therefore, with this configuration, the lengths of the first lead wire and the second lead wire are equal between the base end and the intermediate position of the first section, reducing the possibility that the first lead wire and the second lead wire will become entangled with each other or with the core wire.

[0013] The present invention can be realized in various forms, for example, in the form of a medical device including a sensor-equipped guidewire, a catheter including a sensor-equipped guidewire, a method for manufacturing a sensor-equipped guidewire, etc. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is an explanatory diagram illustrating the configuration of a sensor-equipped guide wire according to a first embodiment. [Figure 2] FIG. 2 is an enlarged view of the connector assembly. [Figure 3] FIG. 2 is a detailed illustration of the connector assembly, core wire, and cable. [Figure 4] 1A and 1B are cross-sectional views showing cross sections of the proximal end portion of the sensor-equipped guide wire. [Figure 5] FIG. 2 is an enlarged cross-sectional view of the sensor assembly. [Figure 6] FIG. 4 is an explanatory diagram for explaining the details of the configuration of a tubular member. [Figure 7] FIG. 3 is an explanatory diagram for explaining the details of the configuration of a sensor sheet. [Figure 8] 10A to 10C are explanatory diagrams illustrating a process of winding a sensor sheet around a tubular member. [Figure 9] FIG. 2 is a detailed explanatory diagram of a cable disposed between a first section and a second section. [Figure 10] FIG. 10 is an explanatory diagram showing a schematic configuration of a sensor-equipped guide wire according to a second embodiment. [Figure 11] FIG. 2 is an enlarged view of the sensor assembly and its surroundings. [Figure 12] FIG. 10 is an explanatory diagram showing a schematic configuration of a sensor-equipped guide wire according to a third embodiment. [Figure 13] FIG. 10 is a cross-sectional view showing a cross section of a sensor-equipped guide wire according to a fourth embodiment. [Figure 14] FIG. 10 is an explanatory diagram showing a schematic configuration of a sensor-equipped guide wire according to a fifth embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0015] First Embodiment FIG. 1 is an explanatory diagram illustrating the cross-sectional configuration of a sensor-equipped guidewire 1 of the first embodiment. In FIG. 1, the sensor assembly 20 and connector assembly 40 are shown in external appearance. The sensor-equipped guidewire 1 of this embodiment is a device that is inserted into, for example, a cerebral blood vessel and is capable of measuring the electrical resistance of a bodily fluid such as blood flowing through the vessel. The electrical resistance detected by the sensor-equipped guidewire 1 is used, for example, to determine the type of thrombus that has occurred in the cerebral blood vessel.

[0016] In FIG. 1, the axis passing through the center of the sensor-equipped guidewire 1 is represented by axis O (dash line). Hereinafter, the central axes passing through the centers of at least the core wire 10, tubular member 22 (see FIG. 5), first coil body 60, and second coil body 70, which will be described later, among the components of the sensor-equipped guidewire 1, will be described as coinciding with axis O; however, the central axes passing through the centers of the other components may deviate from axis O. FIG. 1 also illustrates X, Y, and Z axes that are orthogonal to one another. The X axis corresponds to the axial direction of the sensor-equipped guidewire 1 (the insertion direction of the sensor-equipped guidewire 1), the Y axis corresponds to the width direction of the sensor-equipped guidewire 1, and the Z axis corresponds to the height direction of the sensor-equipped guidewire 1. The right side of FIG. 1 (the +X axis direction) is referred to as the "distal side" of the sensor-equipped guidewire 1 and each component, and the left side of FIG. 1 (the -X axis direction) is referred to as the "proximal side" of the sensor-equipped guidewire 1 and each component. Furthermore, with regard to the sensor-equipped guidewire 1 and each of its constituent members, the end located on the distal side and its vicinity will be referred to as the "distal portion" or simply the "distal portion," and the end located on the proximal side and its vicinity will be referred to as the "proximal portion" or simply the "proximal portion." The distal side of the sensor-equipped guidewire 1 is the portion that is inserted into the living body, and the proximal side is the portion that is operated by an operator such as a doctor. These points are also common to Figure 1 and subsequent figures.

[0017] The sensor-equipped guide wire 1 includes a core wire 10, a sensor assembly 20, a cable 30, and a connector assembly 40. The core wire 10 is an elongated member extending along the X-axis direction. The core wire 10 has, in order from the distal end to the proximal end, a distal thin-diameter section 11, a tapered section 12, a thick-diameter section 13, a reduced-diameter section 14, and a proximal thin-diameter section 15.

[0018] The distal thin section 11 is located at the distal end of the core wire 10 and has a generally cylindrical shape with a generally constant outer diameter, which is the smallest portion of the core wire 10. In this specification, "substantially constant" is synonymous with "generally constant" and means that the outer diameter is generally constant while allowing for variations due to manufacturing errors, etc. The tapered section 12 is located between the distal thin section 11 and the large diameter section 13 and has an outer diameter that gradually decreases from the base end to the distal end. The large diameter section 13 is located between the tapered section 12 and the reduced diameter section 14 and has a generally cylindrical shape with an outer diameter larger than those of the distal thin section 11 and the proximal thin diameter section 15. The reduced diameter section 14 is located between the large diameter section 13 and the proximal thin diameter section 15 and has an outer diameter that gradually decreases from the distal end to the proximal end. The proximal thin section 15 is provided adjacent to the reduced diameter section 14 from the proximal side, and is a generally cylindrical section with a generally constant outer diameter, where the outer diameter of the core wire 10 is smaller than that of the thick diameter section 13. The outer diameters, lengths in the axial direction O, and cross-sectional shapes of the distal thin diameter section 11, tapered section 12, thick diameter section 13, reduced diameter section 14, and proximal thin diameter section 15 can be determined arbitrarily.

[0019] The sensor assembly 20 is disposed at the distal end of the core wire 10. The sensor assembly 20 is a structure including a sensor array 24s (see FIG. 7) that measures the electrical resistance of body fluids such as blood flowing through blood vessels. The core wire 10 is inserted inside the sensor assembly 20. Details of the sensor assembly 20 will be described later with reference to FIGS. 5 to 8.

[0020] The cable 30 has five lead wires 32a-e (see FIGS. 3(C) and 9(A) and (B)) extending along the core wire 10 to the base end of the core wire 10, and electrically connects a sensor wiring 24c (see FIG. 5) included in the sensor assembly 20, which will be described later, and hollow electrodes 41a-e (see FIG. 2) included in the connector assembly 40, which will be described later. Details of the cable 30 will be described later with reference to FIGS. 3 and 9. Note that "electrically connected" means connected in a state in which current can flow (a conductive state).

[0021] The connector assembly 40 is disposed at the proximal end of the core wire 10. The connector assembly 40 is a structure for connecting to an external device that processes an output signal from a sensor array 24s (see FIG. 7), which will be described later. A part of the proximal thin-diameter portion 15 of the core wire 10 and the cable 30 are disposed inside the connector assembly 40. Details of the connector assembly 40 will be described later with reference to FIGS. 2 to 4.

[0022] Furthermore, as shown in FIG. 1, the sensor-equipped guide wire 1 includes a distal tip 50, a first coil body 60, a second coil body 70, an intermediate joint member 75, a tube 80, and a base-end joint member 85.

[0023] The distal tip 50 joins the distal end of the core wire 10 and the distal end of the first coil body 60. The distal tip 50 can be formed using any bonding agent, for example, metal solder such as silver solder, gold solder, zinc, Sn—Ag alloy, or Au—Sn alloy, or an adhesive such as an epoxy adhesive.

[0024] The first coil body 60 and the second coil body 70 are flexible, substantially cylindrical coil bodies having a substantially constant outer diameter from the base end side to the tip end side. The first coil body 60 is arranged to surround the tip end of the core wire 10. The second coil body 70 is arranged to surround the core wire 10 and the cable 30 on the base end side of the first coil body 60. Specifically, the second coil body 70 is arranged to surround the core wire 10 and the cable 30 on the base end side of the sensor assembly 20. The first coil body 60 and the second coil body 70 are joined to the sensor assembly 20. In this embodiment, the first coil body 60 and the second coil body 70 are single-strand coils formed by winding a single wire into a single strand. The first coil body 60 and the second coil body 70 may be multi-strand coils formed by winding multiple strands of multiple wires, single-strand stranded coils formed by winding a single strand of a stranded wire made by twisting multiple wires together, or multi-strand stranded coils formed by using multiple strands of wires made by twisting multiple wires together and winding each strand of wire multiple times. The outer diameter and inner diameter of the first coil body 60 and the second coil body 70 can be determined arbitrarily.

[0025] The tube 80 is a generally cylindrical tube having a generally constant outer diameter from the proximal end to the distal end. The tube 80 is disposed so as to surround the core wire 10 and the cable 30 on the proximal side of the second coil body 70. The tube 80 is preferably antithrombogenic, flexible, and biocompatible, and can be formed from a resin or metal material. Examples of resin materials that can be used include polyimide resin, polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of metal materials that can be used include stainless steel such as SUS304, nickel-titanium alloy, and cobalt-chromium alloy. The outer surface of the tube 80 and the outer surfaces of the first coil body 60 and second coil body 70 may be coated with a hydrophilic or hydrophobic resin.

[0026] The intermediate joint member 75 joins the core wire 10, the cable 30, the second coil body 70, and the tube 80. The proximal joint member 85 joins the core wire 10, the cable 30, the connector assembly 40, and the tube 80. As with the distal tip 50, any bonding agent can be used for the intermediate joint member 75 and the proximal joint member 85. The first section S1, the second section S2, the intermediate position MP, the portion P1, and the portion P2 shown in FIG. 1 will be described later.

[0027] Next, the configuration of the connector assembly 40 will be described in detail. Fig. 2 is an enlarged view of the connector assembly 40. The connector assembly 40, which is disposed at the proximal end of the sensor-equipped guide wire 1, contains the core wire 10 and the cable 30 inside, as shown in Fig. 2. The connector assembly 40 includes hollow electrodes 41a-e, inter-ring joining members 43a-e, and blocking members 45a-e.

[0028] FIG. 3 is an explanatory diagram illustrating the connector assembly 40 and the core wire 10 and the cable 30 contained therein in detail. FIG. 3(A) shows a structure 40p obtained by removing the blocking members 45a-e from the connector assembly 40. That is, the structure 40p includes hollow electrodes 41a-e and inter-ring connecting members 43a-e. Each of the hollow electrodes 41a-e is disposed at the proximal end of the core wire 10 and contains the core wire 10 and the cable 30 therein (see FIG. 2). The hollow electrodes 41a-e are disposed in the order of 41a, 41b, 41c, 41d, and 41e from the distal end to the proximal end. In this embodiment, the hollow electrodes 41a-e are annular electrodes. Each of the hollow electrodes 41a-e has a through-hole 42a-e formed therein. In the connector assembly 40, the through holes 42a to 42e are closed by closing members 45a to 45e, respectively, as shown in Fig. 2. The closing members 45a to 45e are insulating members made of polyimide resin or the like.

[0029] The inter-ring joint members 43a-e are insulating joint members made of polyimide resin or the like. The inter-ring joint member 43a is disposed adjacent to the hollow electrode 41a from the distal end side and joins the hollow electrode 41a to the tube 80 (see FIG. 1). The inter-ring joint members 43b-e are disposed between the hollow electrodes 41a-e and join the hollow electrodes 41a-e to each other. The inter-ring joint members 43a-e, made of resin, are relatively flexible and therefore represent low rigidity portions of the connector assembly 40. For this reason, when the connector assembly 40 is bent, a load is likely to be applied mainly to the inter-ring joint members 43a-e and is less likely to be applied to the hollow electrodes 41a-e, which have high rigidity.

[0030] Fig. 3(B) shows a portion of the core wire 10 that is disposed inside the connector assembly 40. As shown in Fig. 3(B), the portion of the core wire 10 that is disposed inside the connector assembly 40 is covered with an insulating tube 16 made of polyimide resin or the like.

[0031] FIG. 3(C) shows a portion of the cable 30 that is disposed inside the connector assembly 40. The five lead wires 32a-e that make up the cable 30 are disposed in the order of lead wires 32a, 32b, 32c, 32d, and 32e from the +Y-axis direction side to the −Y-axis direction side (from the top to the bottom of the drawing). Each of the lead wires 32a-e has a core wire 34a-e and an insulating tube 36a-e. The core wires 34a-e are formed of a conductor. The insulating tubes 36a-e cover each of the core wires 34a-e. The insulating tubes 36a-e are formed of a polyimide resin or the like, similar to the insulating tube 16 that covers the core wire 10. As shown in FIG. 3(C), the portions of the insulating tubes 36a-e that are disposed inside the connector assembly 40 are integrated by fusion-bonding their outer circumferential surfaces together. That is, in the portion of the cable 30 that is disposed inside the connector assembly 40, the lead wires 32a-e are integrated except for a small portion. Also, as shown in Fig. 3(C), in the portion of the cable 30 that is disposed inside the connector assembly 40, the entire circumference of each of the insulating tubes 36a-e is partially peeled off, exposing the core wires 34a-e. This exposed portion corresponds to the non-integrated portion.

[0032] Fig. 3(D) is an explanatory diagram illustrating a state in which the structure 40p contains the core wire 10 and the cable 30 inside. The state shown in Fig. 3(D) corresponds to the state shown in Fig. 2 with only the blocking members 45a-e removed. As shown in Fig. 3(D), the portions of the cable 30 where the insulating tubes 36a-e have been peeled off to expose the core wires 34a-e are disposed inside the through holes 42a-e. The state in which the through holes 42a-e are blocked by the blocking members 45a-e is the state shown in Fig. 2.

[0033] FIG. 4 is a cross-sectional view showing each cross section of the proximal end of the sensor-equipped guide wire 1. FIG. 4(A) shows a cross section taken along line F4A-F4A in FIG. 2. The cross section in FIG. 4(A) is a cross section of the cable 30 at a portion where the core wire 34d is exposed. FIG. 4(B) shows a cross section taken along line F4B-F4B in FIG. 2. The cross section in FIG. 4(B) is a cross section of the cable 30 at a portion where the core wire 34d is covered with the insulating tube 36d. FIG. 4(C) shows a longitudinal cross section taken along line F4C-F4C in FIGS. 4(A) and 4(B). The first region R1 shown in FIG. 4(C) is a region inside the hollow electrode 41d where the exposed core wire 34d is located in the X-axis direction. That is, the cross section in FIG. 4(A) is a cross section of the first region R1. In the longitudinal cross section shown in FIG. 4(C), the core wire 34d, which is hidden by the conductive connecting member 47c (described later) and therefore not visible, is represented by a dashed line. In the first region R1, the insulating tube 36d of the lead wire 32d is peeled off to expose the core wire 34d, so the lead wire 32d arranged in the first region R1 is composed only of the core wire 34d. The second region R2 shown in FIG. 4(C) is a region inside the hollow electrode 41d that is different from the first region R1 and is a region where the core wire 34d covered with the insulating tube 36d is arranged in the X-axis direction. In other words, the cross section of FIG. 4(B) is a cross section of the second region R2. The third region R3 shown in FIG. 4(C) is a region inside the hollow electrode 41d that is separated from the second region R2 by the first region R1 and is a region where the core wire 34d covered with the insulating tube 36d is arranged in the X-axis direction, similar to the second region R2.

[0034] As shown in FIGS. 4A to 4C, a connecting member 47 is disposed inside the hollow electrode 41d. The connecting member 47 connects the core wire 10, the lead wires 32a to 32e, and the hollow electrode 41d. The connecting member 47 includes a conductive connecting member 47c and an insulating connecting member 47i. The conductive connecting member 47c is an adhesive containing metal powder, and is disposed inside the hollow electrode 41d mainly around the exposed portion of the core wire 34d. As shown in FIG. 4A, in the first region R1, the conductive connecting member 47c covers at least a portion of the lead wire 32d (which in the first region R1 is composed only of the core wire 34d) and electrically connects the lead wire 32d (core wire 34d) and the hollow electrode 41d. In this embodiment, the conductive connecting member 47c covers at least half of the outer periphery of the cross section (YZ cross section) of the lead wire 32d (core wire 34d), more specifically, the entire periphery. The insulating connecting member 47i is a non-conductive adhesive and is arranged inside the hollow electrode 41d so as to fill the portion where the conductive connecting member 47c is not arranged. The connecting member 47 arranged in this manner connects the core wire 10, the core wire 34d, and the hollow electrode 41d in the first region R1. More specifically, as described in FIG. 3(B), the core wire 10 arranged inside the connector assembly 40 is covered with the insulating tube 16, and therefore the connecting member 47 connects the core wire 10 and the hollow electrode 41d, and the core wire 10 and the core wire 34d, in an electrically insulated state, in the first region R1. Furthermore, since the connecting member 47 is an adhesive and is filled in the first region R1, the connecting member 47 connects the core wire 10 and the hollow electrode 41d, and the core wire 10 and the core wire 34d, with their relative positions fixed.

[0035] As shown in Fig. 4(A), in the first region R1, the lead wires 32c and 32e are spaced apart from the lead wire 32d. Specifically, in the first region R1, as described above, the lead wire 32d is composed only of the core wire 34d, and the lead wires 32c and 32e are spaced apart from the core wire 34d (lead wire 32d). In the first region R1, the connecting member 47 connects the spaced lead wire 32d (core wire 34d) and the lead wires 32c and 32e to the core wire 10 and the hollow electrode 41d. Meanwhile, as shown in Fig. 4(B), in the second region R2, the lead wires 32c and 32e are integrated with the lead wire 32d. Specifically, in the second region R2, the insulating tubes 36c-e have their outer circumferential surfaces fused together as shown in FIG. 3C, so that the lead wire 32d is integrated with the lead wires 32c and 32e. In the second region R2, the connecting member 47 connects the integrated lead wires 32d and 32c and 32e to the core wire 10 and the hollow electrode 41d. The connection state in the second region R2 described here is similar in the third region R3. Specifically, in the third region R3, the lead wires 32c and 32e are also integrated with the lead wire 32d, and the connecting member 47 connects the integrated lead wires 32d and 32c and 32e to the core wire 10 and the hollow electrode 41d.

[0036] In a first region R1 inside the hollow electrode 41d, the core wire 34d is exposed, and the lead wire 32d electrically connected to the hollow electrode 41d corresponds to the "main lead wire." Furthermore, the lead wires 32c and 32e, which are separated from the lead wire 32d (main lead wire) in the first region R1 inside the hollow electrode 41d and are integrated with the lead wire 32d (main lead wire) in a second region R2 inside the hollow electrode 41d, correspond to the "secondary lead wire." Furthermore, inside the hollow electrodes 41a-c, e, there are first to third regions similar to those inside the hollow electrode 41d, and lead wires corresponding to the "main lead wire" and "secondary lead wire." Specifically, the "main lead wire" of the hollow electrode 41a is the lead wire 32a, and the "secondary lead wire" is the lead wire 32b. The "main lead wire" for hollow electrode 41b is lead wire 32b, and the "secondary lead wire" is lead wires 32a and 32c. The "main lead wire" for hollow electrode 41c is lead wire 32c, and the "secondary lead wire" is lead wires 32b and 32d. The "main lead wire" for hollow electrode 41e is lead wire 32e, and the "secondary lead wire" is lead wire 32d.

[0037] Next, a detailed description will be given of the configuration of the sensor assembly 20. Fig. 5 is an enlarged cross-sectional view of the sensor assembly 20. The sensor assembly 20 includes a tubular member 22, a sensor sheet 24, and spacers 26 and 28.

[0038] FIG. 6 is an explanatory diagram for describing the detailed configuration of the tubular member 22, which is a part of the sensor assembly 20. The tubular member 22 is composed of 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 the tubular portion on the base end side of the tubular member 22. A slit 22s is formed on the side surface of the base end tubular portion 22a, connecting the inside and outside of the base end tubular portion 22a. The intermediate connecting portion 22b is the portion of the tubular member 22 that connects the base end tubular portion 22a and the distal end tubular portion 22c, and its cross section (YZ cross section) is a semicircular portion that exposes the inner surface of the intermediate connecting portion 22b to the outside. The distal end tubular portion 22c is the tubular portion on the distal end side of the tubular member 22, and its cross section (YZ cross section) is approximately circular.

[0039] FIG. 7 is an explanatory diagram illustrating the detailed configuration of the sensor sheet 24, which is part of the sensor assembly 20. The sensor sheet 24 is a sheet-like member that is wound around the tubular member 22. The sensor sheet 24 is composed of a wide portion 24a, a narrow portion 24b, and sensor wiring 24c. The wide portion 24a is a strip-shaped portion that is wider than the narrow portion 24b. A sensor array 24s is arranged on the surface of the wide portion 24a. The sensor array 24s is composed of nine sensors arranged in a grid pattern. These sensors measure the electrical resistance of body fluids such as blood flowing through blood vessels. The narrow portion 24b is a strip-shaped portion that is narrower than the wide portion 24a and is connected to the wide portion 24a. Two microchips 24m connected to the sensor array 24s are arranged on the surface of the narrow portion 24b. The sensor wiring 24c is a wiring that transmits a signal sent from the microchip 24m, and is connected to the narrow portion 24b at a portion of the narrow portion 24b opposite to the side connected to the wide portion 24a.

[0040] FIG. 8 is an explanatory diagram illustrating the process of winding the sensor sheet 24 around the tubular member 22. The state shown in FIG. 8 is a state in which the sensor wiring 24c is arranged inside the tubular member 22 through a slit 22s (not shown in FIG. 8, see FIG. 6) formed in the proximal tubular portion 22a, causing the narrow portion 24b to protrude from the intermediate connection portion 22b to the outside of the tubular member 22, and then annular spacers 26, 28 are attached to the tubular member 22. Specifically, the annular spacers 26, 28 are attached to the ends of the proximal tubular portion 22a and the distal tubular portion 22c that are closer to the intermediate connection portion 22b. In FIG. 8, the portion of the sensor sheet 24 that is arranged inside the tubular member 22 is indicated by a dashed line. When the sensor sheet 24 is wound around the tubular member 22 from this state, the narrow portion 24b of the sensor sheet 24 is first wrapped around the intermediate connection portion 22b located between the spacers 26, 28. At this time, the two microchips 24m arranged on the surface of the narrow portion 24b are wound around the intermediate connector 22b so that one is stacked on top of the other (see FIG. 5). Thereafter, the wide portion 24a is wound around the outer peripheral surfaces of the narrow portion 24b wound around the intermediate connector 22b and the spacers 26 and 28, thereby completing the process of winding the sensor sheet 24 around the tubular member 22. After the sensor sheet 24 is wound, the nine sensors that make up the sensor array 24s are arranged on the outermost periphery of the tubular member 22. Furthermore, in the cross section (YZ cross section) of the tubular member 22, three sensors are arranged at 120° intervals along the circumferential direction.

[0041] Returning to the explanation of Figure 5, the tubular member 22, around which the sensor sheet 24 is provided after the winding process described in Figure 8, is disposed so as to surround the core wire 10. The sensor assembly 20 further includes a distal joint member 25. The distal joint member 25 joins the core wire 10, the tubular member 22, the sensor sheet 24, the spacers 26, 28, the first coil body 60, and the second coil body 70. As with the intermediate joint member 75 and the proximal joint member 85, any bonding agent can be used for the distal joint member 25.

[0042] In this embodiment, as shown in Fig. 5, the distal end portion (tip tubular portion 22c) of the tubular member 22 is disposed inside the proximal end portion of the first coil body 60, and the distal end portion (tip tubular portion 22c) of the tubular member 22 and the proximal end portion of the first coil body 60 are joined together. Also, as shown in Fig. 5, the outer diameter L1 of the proximal end portion of the first coil body 60 is larger than the outer diameter L2 of the tubular member 22 including the sensor sheet 24. The outer diameter L2 is the maximum outer diameter among the outer diameters of the tubular member 22 including the sensor sheet 24. For example, if the outer diameter at a position where the widened portion 24a is wound on the outer peripheral surfaces of the spacers 26, 28 corresponds to the outer diameter L2, the outer diameter L1 is larger than the outer diameter L2. 5, the base end (base end tubular portion 22a) of the tubular member 22 is disposed inside the tip end of the second coil body 70, and the base end (base end tubular portion 22a) of the tubular member 22 and the tip end of the second coil body 70 are joined together. Also, as shown in FIG. 5, the outer diameter L3 of the tip end of the second coil body 70 is larger than the outer diameter L2 of the tubular member 22 including the sensor sheet 24.

[0043] Next, a portion of the cable 30 disposed between the sensor assembly 20 and the connector assembly 40 will be described in detail. Before describing this portion of the cable 30, the first section S1 and the second section S2 shown in FIG. 1 will be described. The first section S1 is located at the distal end of the core wire 10, and is the section in which the sensor assembly 20 is disposed in the X-axis direction. The proximal end of the first section S1 is located at the proximal end of the sensor wiring 24c (see FIG. 5). The second section S2 is located at the proximal end of the core wire 10, and is the section in which the connector assembly 40 is disposed in the X-axis direction. The distal end of the second section S2 is located at the distal end of the inter-ring joint member 43a (see FIG. 2).

[0044] The cable 30 is electrically connected to the sensor wiring 24c in the first section S1 (see FIG. 5) and to each of the hollow electrodes 41a-e in the second section S2. Specifically, the electrical connections in the first section S1 are between the distal ends of the lead wires 32a-e of the cable 30, where a portion of the outer surface of each of the insulating tubes 36a-e is peeled away to expose the core wires 34a-e (not shown), and each of the five core wire connection portions (not shown) provided on the sensor wiring 24c. As described with reference to FIGS. 4A and 4C, the electrical connections in the second section S2 are between each of the lead wires 32a-e (core wires 34a-e) of the cable 30 and each of the hollow electrodes 41a-e via the conductive connecting member 47c.

[0045] 9 is an explanatory diagram illustrating the details of a portion of the cable 30 disposed between the first section S1 and the second section S2. As shown in FIG. 1, an arbitrary position between the base end of the first section S1 and the tip end of the second section S2 is defined as an intermediate position MP. In this case, in the cable 30 disposed between the base end of the first section S1 and the intermediate position MP, the entire lead wires 32a-e in this portion (between the base end of the first section S1 and the intermediate position MP) are not integrated and can move relative to each other, as shown in FIG. 9(A). In other words, in the portion of the cable 30 disposed between the base end of the first section S1 and the intermediate position MP, the lead wires 32a-e can move freely without following each other's movement because the outer circumferential surfaces of the insulating tubes 36a-e are not fused to each other but are separated. The length of the portions of the lead wires 32a-e located between the base end of the first section S1 and the intermediate position MP is longer than the length of that section (between the base end of the first section S1 and the intermediate position MP), and therefore the lead wires 32a-e are arranged in a bent state between those sections. Meanwhile, in the cable located between the intermediate position MP and the tip of the second section S2, the entire lead wires 32a-e in that section (between the intermediate position MP and the tip of the second section S2) are integrated as shown in Fig. 9(B). That is, in the portion of the cable 30 located between the intermediate position MP and the tip of the second section S2, the lead wires 32a-e are integrated by the outer circumferential surfaces of the insulating tubes 36a-e being fused to each other. As shown in Fig. 1, between the base end of the first section S1 and the tip end of the second section S2, the cable 30 is divided into a portion P1 where the lead wires 32a-e are not integrated and a portion P2 where the lead wires 32a-e are integrated, with the intermediate position MP as the boundary. Note that in the cable 30 electrically connected to the sensor wiring 24c from the base end to the tip end of the first section S1, the lead wires 32a-e are integrated. Also, in the cable 30 from the tip end of the second section S2 to the base end, the lead wires 32a-e are integrated except for a portion, as described in Fig. 3(C).

[0046] In this embodiment, as shown in FIG. 1 , the proximal end of the second coil body 70 of the sensor-equipped guide wire 1 corresponds to the intermediate position MP. Therefore, in the cable 30 arranged inside the second coil body 70, the lead wires 32a-e are not integrated and are relatively movable. Furthermore, since the intermediate position MP is a position included in the intermediate joint member 75, the cable 30 is joined to the core wire 10 at the intermediate position MP. Note that, between the sensor assembly 20 and the connector assembly 40, the cable 30 is joined to the core wire 10 at positions where the intermediate joint member 75 and the proximal joint member 85 are arranged, and is not joined to the core wire 10 at positions where the intermediate joint member 75 and the proximal joint member 85 are not arranged. Furthermore, between the sensor assembly 20 and the connector assembly 40, the cable 30 is not wound around the core wire 10 but extends along the core wire 10.

[0047] In this embodiment, the lead wires 32a-e have the same length between the base end of the first section S1 and the intermediate position MP. Note that the term "equal" here allows for manufacturing errors and the like, and even if the lengths of the lead wires 32a-e differ from one another within a predetermined error range, they are considered to be equal.

[0048] As described above, in this embodiment, the lead wires 32a-e are not integrated between the base end of the first section S1 and the intermediate position MP, but are integrated between the intermediate position MP and the tip of the second section S2. Therefore, if one of the lead wires 32a-e is designated as the "first lead wire," the remaining four lead wires correspond to the "second lead wire." In other words, the "first lead wire" is a lead wire that is not integrated with the "second lead wire" between the base end of the first section S1 and the intermediate position MP, and is integrated with the "second lead wire" between the intermediate position MP and the tip of the second section S2.

[0049] As described above, according to the sensor-equipped guidewire 1 of the first embodiment, the lead wire 32d and the hollow electrode 41d are electrically connected in the first region R1 as shown in FIGS. 4(A) and 4(C). Therefore, when the hollow electrode 41d is connected to an external device that processes an output signal from the sensor array 24s, the output signal from the sensor array 24s can be transmitted to the external device via the lead wire 32d and the hollow electrode 41d connected to the sensor wiring 24c. Furthermore, according to the sensor-equipped guidewire 1 of the first embodiment, as shown in FIGS. 4(A) and 4(C), the core wire 10 and the hollow electrode 41d, and the core wire 10 and the lead wire 32d, are connected in an insulated state in the first region R1. Specifically, as shown in FIGS. 4(A) and 4(C), the connecting member 47 covers the lead wire 32d spaced from the lead wires 32c and 32e, and connects the lead wire 32d not only to the hollow electrode 41d but also to the core wire 10. This can prevent the relative position of the hollow electrode 41d with respect to the core wire 10 from changing. This can prevent the lead wire 32d from being damaged by being pinched between the hollow electrode 41d and the core wire 10 whose relative position has changed. Furthermore, in the first region R1, the core wire 10 is insulated from the hollow electrode 41d and the lead wire 32d, which can prevent the output signal from the sensor array 24s from being transmitted to the core wire 10. The configuration and effects described here are also the same in the first region inside the hollow electrodes 41a-c, e.

[0050] For example, when the lead wire 32d is integrated with the lead wires 32c and 32e, the portions of the outer circumferential surface of the lead wire 32d and the outer circumferential surfaces of the lead wires 32c and 32e that are in contact with each other are not exposed to the outside. On the other hand, when the lead wire 32d is spaced apart from the lead wires 32c and 32e, the entire outer circumferential surfaces of the lead wire 32d and the lead wires 32c and 32e are exposed to the outside. In the sensor-equipped guide wire 1 of the first embodiment, as shown in FIGS. 4(A) and 4(B), the lead wire 32d is spaced apart from the lead wires 32c and 32e in the first region R1, and is integrated with the lead wires 32c and 32e in the second region R2. Therefore, the lead wire 32d and the lead wires 32c, 32e that are separated in the first region R1 can have a larger connection area on the outer peripheral surface of the lead wire 32d and the outer peripheral surfaces of the lead wires 32c, 32e that can be connected with the connecting member 47, compared to the integrated lead wire 32d and the lead wires 32c, 32e. Therefore, the connection strength between the lead wire 32d and the lead wires 32c, 32e and the core wire 10 and the hollow electrode 41d can be increased in the first region R1. On the other hand, in the second region R2, even if the connection between the lead wire 32d and the lead wires 32c, 32e and the core wire 10 and the hollow electrode 41d is severed due to peeling of the connecting member 47 or the like, entanglement of the lead wires 32d and the lead wires 32c, 32e can be suppressed. In the second region R2, the connecting member 47 connects the lead wire 32d to the core wire 10 and the hollow electrode 41d while the lead wires 32c and 32e are integrated together. This prevents the lead wire 32d from separating from the lead wires 32c and 32e in the first region R1 and progressing toward the second region R2. The configuration and effects described here also apply to the first and second regions inside the hollow electrodes 41a-c, e.

[0051] Furthermore, in the sensor-equipped guide wire 1 of the first embodiment, the lead wires 32c and 32e are also integrated with the lead wire 32d in the third region R3. Therefore, similar to the second region R2, when the connection between the lead wires 32d and 32c and 32e and the core wire 10 and the hollow electrode 41d is severed, entanglement of the lead wires 32d and 32c and 32e can be prevented in the third region R3. Furthermore, in the third region R3, the connecting member 47 connects the lead wire 32d to the core wire 10 and the hollow electrode 41d while the lead wires 32c and 32e are integrated with the lead wires 32c and 32e. Therefore, separation of the lead wire 32d from the lead wires 32c and 32e in the first region R1 can be prevented from progressing toward the third region R3. The configuration and effects described here also apply to the third region inside the hollow electrodes 41a-c and 41e.

[0052] 4(A), in the sensor-equipped guide wire 1 of the first embodiment, in the first region R1, the connecting member 47 covers the entire outer periphery of the cross section (YZ cross section) of the lead wire 32d. This makes it possible to make the connecting member 47 less likely to peel off from the lead wire 32d. This makes it possible to prevent the connection between the lead wire 32d and the core wire 10 and the connection between the lead wire 32d and the hollow electrode 41d from being severed due to the connecting member 47 being peeled off from the lead wire 32d. The configuration and effects described here also apply to the first region inside the hollow electrodes 41a-c, e.

[0053] Furthermore, in the sensor-equipped guidewire 1 of the first embodiment, as shown in FIG. 5 , the distal end (tip tubular portion 22c) of the tubular member 22 is disposed inside the proximal end of the first coil body 60, and the distal end (tip tubular portion 22c) of the tubular member 22 and the proximal end of the first coil body 60 are joined together. This prevents the central axis of the tubular member 22 from shifting from the central axis of the first coil body 60. Since the first coil body 60 forms the outer shape of the distal end of the sensor-equipped guidewire 1, the central axis of the first coil body 60 corresponds to the central axis of the distal end of the sensor-equipped guidewire 1. In other words, it is possible to prevent the central axis of the tubular member 22 from shifting from the central axis of the sensor-equipped guidewire 1. This improves torque transmissibility at the distal end of the sensor-equipped guidewire 1, thereby improving the operability of the sensor-equipped guidewire 1.

[0054] 5, in the sensor-equipped guidewire 1 of the first embodiment, the outer diameter L1 of the proximal end of the first coil body 60 is larger than the outer diameter L2 of the tubular member 22 including the sensor sheet 24. Therefore, when the sensor-equipped guidewire 1 is inserted into a biological lumen such as a blood vessel, the sensor sheet 24 provided around the tubular member 22 or the tubular member 22 is less likely to come into contact with biological tissue. As a result, the possibility of damage to the sensor sheet 24 can be reduced, and the safety of the sensor-equipped guidewire 1 with respect to biological tissue can be improved.

[0055] Furthermore, in the sensor-equipped guidewire 1 of the first embodiment, as shown in FIG. 5 , the proximal end (proximal end tubular portion 22 a) of the tubular member 22 is disposed inside the distal end of the second coil body 70, and the proximal end (proximal end tubular portion 22 a) of the tubular member 22 and the proximal end of the second coil body 70 are joined together. This prevents the central axis of the tubular member 22 from shifting from the central axis of the second coil body 70. Because the second coil body 70 constitutes part of the outer shape of the sensor-equipped guidewire 1, the central axis of the second coil body 70 corresponds to part of the central axis of the sensor-equipped guidewire 1. In other words, this prevents the central axis of the tubular member 22 from shifting from the central axis of the sensor-equipped guidewire 1. This improves torque transmissibility in the portion of the sensor-equipped guidewire 1 whose outer shape is formed by the second coil body 70, thereby further improving the operability of the sensor-equipped guidewire 1.

[0056] 5, in the sensor-equipped guidewire 1 of the first embodiment, the outer diameter L3 of the distal end of the second coil body 70 is larger than the outer diameter L2 of the tubular member 22 including the sensor sheet 24. Therefore, when the sensor-equipped guidewire 1 is inserted into a biological lumen such as a blood vessel, the sensor sheet 24 provided around the tubular member 22 or the tubular member 22 is less likely to come into contact with biological tissue. As a result, the possibility of damage to the sensor sheet 24 can be reduced, and the safety of the sensor-equipped guidewire 1 with respect to biological tissue can be improved.

[0057] In the sensor-equipped guidewire 1 of the first embodiment, the lead wires 32a-e are not integrated into the cable 30 (see FIG. 1) arranged between the base end of the first section S1 and the intermediate position MP, and are therefore relatively movable, as shown in FIG. 9(A). Therefore, the lead wires 32a-e can move freely between the base end of the first section S1 and the intermediate position MP without following each other's movements, ensuring flexibility at the distal end of the sensor-equipped guidewire 1. In the sensor-equipped guidewire 1 of the first embodiment, the lead wires 32a-e are integrated into the cable 30 (see FIG. 1) arranged between the intermediate position MP and the distal end of the second section S2, as shown in FIG. 9(B). Therefore, entanglement of the lead wires 32a-e can be prevented between the intermediate position MP and the distal end of the second section S2, ensuring operability at the proximal end of the sensor-equipped guidewire 1 relative to the intermediate position MP. Therefore, according to the sensor-equipped guide wire 1 of the first embodiment, it is possible to provide a sensor-equipped guide wire 1 that is easier to handle because it is possible to achieve both flexibility at the tip end and operability at the base end.

[0058] Furthermore, between the base end of the first section S1 and the intermediate position MP, the non-integrated lead wires 32a-e can be prevented from causing bending of the core wire 10 due to the lead wire 32a-e getting caught on the second coil body 70 pulling on the core wire 10. This is because, for example, even if one of the non-integrated lead wires 32a-e gets caught on the second coil body 70, it is unlikely to generate a pulling force strong enough to cause bending of the core wire 10. Furthermore, by being arranged in a bent state, the non-integrated lead wires 32a-e can be prevented from breaking due to rotation of the sensor-integrated guide wire 1 or insertion into a bent section.

[0059] Furthermore, in the sensor-equipped guidewire 1 of the first embodiment, the lead wires 32a-e are not integrated into the cable 30 arranged inside the second coil body 70 and are therefore relatively movable. Therefore, the flexible portion of the cable 30 where the lead wires 32a-e are not integrated is covered with the flexible second coil body 70, making it possible to provide a sensor-equipped guidewire 1 with secured flexibility on the distal end side.

[0060] Furthermore, in the sensor-equipped guide wire 1 of the first embodiment, the cable 30 is joined to the core wire 10 at the intermediate position MP. This prevents the integrated lead wires 32a-e on the proximal side from being pulled away by the unintegrated lead wires 32a-e on the distal side of the intermediate position MP. In other words, it is possible to maintain a boundary between a portion where the lead wires 32a-e are not integrated and a portion where the lead wires 32a-e are integrated, with the intermediate position MP as the boundary.

[0061] Furthermore, in the sensor-equipped guidewire 1 of the first embodiment, the lead wires 32a-e are all equal in length between the proximal end of the first section S1 and the intermediate position MP. For example, if the length of the lead wire 32d is longer than the lengths of the lead wires 32a-c, e between the proximal end of the first section S1 and the intermediate position MP, the length of the lead wire 32d corresponds to the length of the lead wires 32a-c, e plus an excess length. The longer this excess length is, the higher the possibility that the lead wire 32d will become entangled with the lead wires 32a-c, e or the core wire 10. Therefore, in the sensor-equipped guidewire 1 of the first embodiment, the lead wires 32a-e are all equal in length between the proximal end of the first section S1 and the intermediate position MP, which reduces the possibility that the lead wires 32a-e will become entangled with each other or with the core wire 10.

[0062] Second Embodiment 10 is an explanatory diagram showing the schematic configuration of a sensor-equipped guidewire 1A of the second embodiment. The sensor-equipped guidewire 1A of the second embodiment differs from the sensor-equipped guidewire 1 of the first embodiment (FIG. 1) in that it includes a sensor assembly 20a, an inner coil body 62, a first tip joint member 64, and a second tip joint member 66.

[0063] 11 is an enlarged view of the sensor assembly 20a and its surroundings. The sensor assembly 20a is the same as the sensor assembly 20 of the first embodiment, except that it includes a distal joint member 25a that is different from the distal joint member 25 of the first embodiment. The distal joint member 25a joins the core wire 10, the tubular member 22, the sensor sheet 24, the spacers 26 and 28, the first coil body 60, the second coil body 70, and the inner coil body 62.

[0064] The inner coil body 62 is disposed between the first coil body 60 and the core wire 10 and surrounds the distal end of the core wire 10. The proximal end of the inner coil body 62 is disposed inside the distal end (tip tubular portion 22c) of the tubular member 22. The first tip joining member 64 joins the first coil body 60 and the inner coil body 62. The second tip joining member 66 joins the proximal end of the inner coil body 62 and the core wire 10. As with the distal joining member 25, the intermediate joining member 75, and the proximal joining member 85, any joining agent may be used for the first tip joining member 64 and the second tip joining member 66. For example, a brazing material or adhesive made of silver, tin, copper, or the like may be used for the first tip joining member 64 and the second tip joining member 66.

[0065] The sensor-equipped guidewire 1A of the second embodiment as described above can also achieve the same effects as those of the first embodiment. Furthermore, according to the sensor-equipped guidewire 1A of the second embodiment, the proximal end of the inner coil body 62 is disposed between the distal end (distal tubular portion 22c) of the tubular member 22 and the core wire 10, and therefore, displacement of the relative position of the tubular member 22 with respect to the core wire 10 can be suppressed. In other words, displacement of the central axis of the tubular member 22 from the central axis of the core wire 10 can be suppressed. Therefore, the torque transmissibility of the sensor-equipped guidewire 1A is improved, and operability can be further improved.

[0066] <Third embodiment> Fig. 12 is an explanatory diagram showing the schematic configuration of a sensor-equipped guidewire 1B of the third embodiment. The sensor-equipped guidewire 1B of the third embodiment differs from the sensor-equipped guidewire 1A of the second embodiment (Fig. 10) in that the position of the intermediate position MP is different and that a first intermediate joining member 77 and a second intermediate joining member 79 are provided instead of the intermediate joining member 75 of the first and second embodiments.

[0067] As described in the first embodiment, the intermediate position MP corresponds to the boundary between the portion where the lead wires 32a-e are not integrated and the portion where the lead wires 32a-e are integrated. In the sensor-equipped guidewires 1 and 1A of the first and second embodiments, the intermediate position MP was located at the proximal end of the second coil body 70, but in the sensor-equipped guidewire 1B of the third embodiment, the intermediate position MP is located closer to the proximal end than the proximal end of the second coil body 70. A first intermediate joint member 77 joins the second coil body 70 and the tube 80. A second intermediate joint member 79 is disposed so as to include the intermediate position MP and joins the core wire 10, the cable 30, and the tube 80. That is, in the sensor-equipped guidewire 1B of the third embodiment, the cable 30 is also joined to the core wire 10 at the intermediate position MP.

[0068] The sensor-equipped guidewire 1B of the third embodiment as described above can also achieve the same effects as those of the first embodiment. Furthermore, the sensor-equipped guidewire 1B of the third embodiment can provide a sensor-equipped guidewire 1B that ensures flexibility from the proximal end of the second coil body 70 to the proximal end side.

[0069] <Fourth embodiment> Fig. 13 is a cross-sectional view showing a cross section of a sensor-equipped guidewire 1C of the fourth embodiment. The cross section of Fig. 13 corresponds to the cross section of the sensor-equipped guidewire 1 of the first embodiment shown in Fig. 4(C). The sensor-equipped guidewire 1C of the fourth embodiment is the same as the sensor-equipped guidewire 1 of the first embodiment, except that compared to the sensor-equipped guidewire 1 of the first embodiment, the sensor-equipped guidewire 1C of the fourth embodiment is different from the sensor-equipped guidewire 1 of the first embodiment mainly in the arrangement of the first region inside the hollow electrodes 41a-e (the region where the exposed core wires 34a-e are arranged in the X-axis direction) and that no through holes 42a-e are formed in the hollow electrodes 41a-e.

[0070] In the sensor-equipped guidewire 1 of the first embodiment, for example, using the hollow electrode 41d, as shown in FIG. 4C, the entire core wire 34d exposed in the X-axis direction is disposed inside the hollow electrode 41d. However, in the sensor-equipped guidewire 1C of the fourth embodiment, as shown in FIG. 13, a portion of the core wire 34d exposed in the X-axis direction is disposed inside the hollow electrode 41d, and the remaining portion is disposed inside the inter-ring joint member 43d. The portion of the core wire 34d exposed in the X-axis direction that is disposed inside the hollow electrode 41d corresponds to the first region R1. Due to the arrangement of the first region R1, the sensor-equipped guidewire 1C of the fourth embodiment has a second region R2 but no third region R3. Although the arrangement of the first region R1 is different, the conductive connecting member 47c is disposed around the core wire 34d exposed in the first region R1, as in the first embodiment. The conductive connecting member 47c is also arranged around the core wire 34d that is arranged inside the inter-ring joint member 43d.

[0071] The sensor-equipped guidewire 1C of the fourth embodiment as described above can also achieve the same effects as those of the first embodiment. Furthermore, according to the sensor-equipped guidewire 1C of the fourth embodiment, since no through-holes 42a-e are formed in the hollow electrodes 41a-e, it is possible to provide a sensor-equipped guidewire 1C equipped with a highly rigid connector assembly 40.

[0072] Fifth Embodiment 14 is an explanatory diagram showing the schematic configuration of a sensor-equipped guidewire 1D of the fifth embodiment. The sensor-equipped guidewire 1D of the fifth embodiment differs from the sensor-equipped guidewire 1 of the first embodiment (FIG. 1) in that it further includes a proximal tube 90 and a tube joint member 95.

[0073] In the sensor-equipped guidewire 1D of the fifth embodiment, the length of the tube 80 in the X-axis direction is shorter than that of the sensor-equipped guidewire 1A of the first embodiment (FIG. 1). A proximal tube 90 is disposed between the shortened tube 80 and the connector assembly 40. The proximal tube 90 is a substantially cylindrical tube having a substantially constant outer diameter from the proximal end to the distal end, similar to the tube 80. The proximal tube 90 is formed of a material having a higher strength than the tube 80. A tube connecting member 95 connects the tube 80 and the proximal tube 90.

[0074] The sensor-equipped guidewire 1D of the fifth embodiment described above can also achieve the same effects as those of Embodiment 1. Furthermore, according to the sensor-equipped guidewire 1D of the fifth embodiment, the proximal tube 90, which has greater strength than the tube 80, is disposed on the proximal side, so that the sensor-equipped guidewire 1D can be provided with improved operability on the proximal side.

[0075] <Modification of this embodiment> The present invention is not limited to the above-described embodiment, and can be embodied in various forms without departing from the spirit of the invention. For example, the following modifications are also possible.

[0076] [Variation 1] In the first to fifth embodiments, the configuration of the sensor-equipped guidewires 1, 1A to D has been exemplified. However, the configuration of the sensor-equipped guidewire can be modified in various ways. For example, the sensor-equipped guidewires 1, 1A to D have sensors that measure the electrical resistance of bodily fluids such as blood flowing in blood vessels, but this is not limiting. For example, the sensor-equipped guidewire may have a sensor that measures blood pressure (intravascular pressure). The blood pressure measured by such a sensor is used to derive the fractional flow reserve (FFR). Coronary flow reserve The volume ratio is the pressure behind the stenosis relative to the pressure in front of the stenosis, and can be used as an index of physiological stenosis severity.

[0077] [Variation 2] 3(C), in the above-described embodiment, in the portion of the cable 30 disposed inside the connector assembly 40, a portion of each of the insulating tubes 36a-e is an exposed portion where the core wires 34a-e are exposed by being peeled off the entire circumference, but this is not limited thereto. For example, each of the insulating tubes 36a-e may be an exposed portion where the core wires 34a-e are exposed by being peeled off the entire circumference (i.e., the insulating tubes 36a-e remain in the portions other than the peeled portions of the entire circumference).

[0078] [Variation 3] 4A to 4C, the connecting member 47 is disposed (filled) without gaps inside the hollow electrode 41d. However, this is not limited to this. That is, in the first region R1, the connecting member 47 may be disposed arbitrarily inside the hollow electrode 41d as long as it electrically connects the lead wire 32d (core wire 34d) and the hollow electrode 41d and also connects the core wire 10 and the hollow electrode 41d, and the core wire 10 and the core wire 34d, while maintaining electrical insulation. For example, inside the hollow electrode 41d, the connecting member 47 may be disposed with gaps, or the connecting member 47 may not be connected among the first to third regions R1 to R3, but may be disposed independently in each region. Furthermore, when the portion of the core wire 10 located inside the connector assembly 40 is covered with the insulating tube 16, the connecting member 47 may be formed only from the conductive connecting member 47c without including the insulating connecting member 47i. On the other hand, when the portion of the core wire 10 located inside the connector assembly 40 is not covered with the insulating tube 16, the connecting member 47 may be arranged inside the hollow electrode 41d so that the periphery of the core wire 10 is covered with the insulating connecting member 47i and the remaining portion is filled with the conductive connecting member 47c. Furthermore, in the first embodiment, the conductive connecting member 47c is arranged to cover the entire outer periphery of the cross section (YZ cross section) of the core wire 34d, but the present invention is not limited to this. The conductive connecting member 47c may be arranged in any manner as long as it is arranged to connect at least a portion of the outer periphery of the cross section (YZ cross section) of the core wire 34d to the hollow electrode 41d.

[0079] [Variation 4] 2, each of the hollow electrodes 41a-e has a through hole 42a-e, but each of the hollow electrodes 41a-e may have two or more through holes, not just one. When two or more through holes are formed, the insulating tubes 36a-e are peeled off to expose the core wires 34a-e, and the exposed portions may be formed in the same number as the number of through holes, and the exposed portions may be disposed inside the respective through holes.

[0080] [Variation 5] In addition, in the above-described embodiment, the sensor sheet 24, which is a sheet-like member, is wound around the periphery of the tubular member 22, but this is not limiting, and the sensor does not have to be a sheet-like member, and may be attached to the tubular member 22 in any manner as long as it is attached to the tubular member 22. For example, the sensor may be attached directly to the outer circumferential surface or inner circumferential surface of the tubular member 22, or may be attached indirectly via another member.

[0081] [Variation 6] Furthermore, in the above-described embodiment, as shown in Figures 5 and 11, the cable 30 and the sensor wiring 24c are connected outside the tubular member 22 (closer to the base end of the tubular member 22), but they may also be connected inside the tubular member 22.

[0082] [Variation 7] In the above-described embodiment, the second coil body 70 is disposed as a tubular member surrounding the core wire 10 and the cable 30 on the proximal side of the first coil body 60, but this is not limiting. For example, the tubular member surrounding the core wire 10 and the cable 30 on the proximal side of the first coil body 60 may be a substantially cylindrical tube, or a tube with a spiral slit formed on its outer circumferential surface, as long as it is flexible.

[0083] [Variation 8] In the above embodiment, in the cable 30 arranged between the base end of the first section S1 and the intermediate position MP, the lead wires 32a-e are not entirely integrated in that section (between the base end of the first section S1 and the intermediate position MP), but only some of the lead wires 32a-e in that section may not be integrated. For example, only the portions of the lead wires 32a-e in that section between a position more proximal than the base end of the first section S1 and the intermediate position MP may not be integrated, or the lead wires 32a-e in that section may have scattered portions that are not integrated.

[0084] [Variation 9] In the above-described embodiment, the lead wires 32a-e are not integrated between the base end of the first section S1 and the intermediate position MP (referred to as the distal section here), but are integrated between the intermediate position MP and the tip of the second section S2 (referred to as the proximal section here). However, this is not limited to this. For example, the lead wires 32a-e may not be integrated in the distal section, and among the lead wires 32a-e, a combination of lead wires 32a-b and a combination of lead wires 32c-e may be integrated separately in the proximal section. Furthermore, the lead wires 32a-b may not be integrated in the distal section but may be integrated in the proximal section, and the lead wires 32c-e may be integrated in both the distal section and the proximal section. In other words, as long as the number of lead wires integrated in the distal section is reduced compared to the proximal section, any number of lead wires may be integrated with other lead wires in the proximal section but not in the distal section.

[0085] [Variation 10] 3(C) and 9, the lead wires are integrated by fusing the outer circumferential surfaces of the insulating tubes together, but this is not limiting. For example, the lead wires may be integrated by bundling two or more lead wires with an expandable annular member, or by arranging the lead wires inside a tubular member that can accommodate two or more lead wires.

[0086] [Variation 11] In the first embodiment, the cable 30 (portion P2 where the lead wires 32a to 32e are integrated) and the core wire 10 are not joined between the intermediate joint member 75 and the base-end joint member 85. However, this is not limited to this. For example, the cable 30 (portion P2 where the lead wires 32a to 32e are integrated) and the core wire 10 may be joined with an adhesive or the like between the intermediate joint member 75 and the base-end joint member 85.

[0087] [Variation 12] In the first embodiment, the cable 30 is not wound around the core wire 10 but extends along the core wire 10 between the sensor assembly 20 and the connector assembly 40. However, this is not limited to this. For example, the portion P2 of the cable 30 where at least the lead wires 32a-e are integrated (the portion between the intermediate joint member 75 and the proximal joint member 85) may be wound around the core wire 10.

[0088] [Variation 13] In addition, in the first to third embodiments, a proximal tube 90 may be disposed instead of the tube 80. That is, the core wire 10 and the cable 30 between the intermediate joint member 75 and the proximal joint member 85 may be surrounded by the proximal tube 90.

[0089] [Variation 14] The configurations of the sensor-equipped guidewires 1 and 1A-D of the first to fifth embodiments and the configurations of the modifications 1-8 may be combined as appropriate. For example, in the sensor-equipped guidewire 1 of the first embodiment, the intermediate position MP may be located closer to the proximal end than the proximal end of the second coil body 70, as described in the third embodiment. Furthermore, in the sensor-equipped guidewires 1A and 1B of the second and third embodiments, the hollow electrodes 41a-e may not have through-holes 42a-e, as described in the fourth embodiment, and a proximal tube 90 and a tube joint member 95 may be provided, as described in the fifth embodiment.

[0090] This aspect has been described above based on embodiments and modifications. However, the above-described embodiments 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. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate. [Explanation of symbols]

[0091] 1, 1A~D...Guide wire 10...Core wire 11...Tip narrow part 12...Tapered section 13...Thick diameter part 14...Reduced diameter part 15...Proximal narrow diameter part 16...Insulating tube 20, 20a...Sensor assembly 22...Tubular member 22a...base end tubular portion 22b...Intermediate joint 22c...Tip cylindrical part 22s...Slit 24...Sensor sheet 24a...Wide section 24b…Narrow width part 24c...Sensor wiring 24m...microchip 24s...Sensor array 25, 25a... Tip side joining member 26...Spacer 30…Cable 32a~e...Lead wire 34a~e...Core wire 36a~e...Insulating tube 40...Connector assembly 40p…Structure 41a~e...Hollow electrode 42a~e...Through hole 43a to e... Inter-ring joint members 45a to 45e: Closing members 47...Connecting member 47c...Conductive connecting member 47i...Insulating connecting member 50...Tip 60...First coil body 62...Inner coil body 64...First tip joint member 66...Second tip joining member 70...Second coil body 75...Intermediate joint member 77...First intermediate joining member 79...Second intermediate joining member 80...Tube 85...Base end joining member 90...Base tube 95...Tube joint member

Claims

1. A sensor-equipped guidewire, A core wire; a sensor disposed in a first section located at a distal end of the core wire; an electrode disposed on a second section located at a proximal end of the core wire; a cable having first and second leads extending along the core wire to a proximal end of the core wire; Equipped with the cable is electrically connected to the wiring of the sensor in the first section and electrically connected to the electrode in the second section; When an arbitrary position between the base end of the first section and the tip end of the second section is defined as an intermediate position, In the cable disposed between the base end of the first section and the intermediate position, the first lead wire and the second lead wire are not integrated and are movable relative to each other, A sensor-equipped guide wire, wherein the first lead wire and the second lead wire are integrated in the cable arranged between the intermediate position and the tip of the second section.

2. The sensor-equipped guidewire according to claim 1, further comprising: a flexible tubular member surrounding the core wire and the cable; A sensor-equipped guide wire, wherein in at least a portion of the cable arranged inside the tubular member, the first lead wire and the second lead wire are not integrated and are capable of relative movement.

3. The sensor-equipped guidewire according to claim 2, The intermediate position is located closer to the proximal end than the proximal end of the tubular member.

4. The sensor-equipped guidewire according to claim 3, The sensored guidewire, wherein the cable is joined to the core wire at the intermediate location.

5. The sensor-equipped guide wire according to any one of claims 2 to 4, A sensor-equipped guidewire, wherein the length of the first lead wire and the length of the second lead wire are equal between the base end of the first section and the intermediate position.

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