Sensor-equipped guide wire

Abstract

A sensor-equipped guide wire equipped with a core wire, a sensor positioned at the tip end section of the core wire, a main lead wire which is electrically connected to the sensor and extends along the core wire to the base end section of the core wire, a hollow electrode which is positioned in the base end section of the core wire and includes the core wire and the main lead wire on the inside thereof, and a connecting member for connecting the core wire, the main lead wire and the hollow electrode inside the hollow electrode, wherein the connecting member covers at least part of the main lead wire in a first region inside the hollow electrode, electrically connects the main lead wire and the hollow electrode to one another, and connects the core wire and the hollow electrode to one another and the core wire and the main lead wire to one another in an insulated state.

Description

Sensored guidewire

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

[0002] Various guidewires have been proposed as guidewires to be inserted into biological lumens such as blood vessels. For example, Patent Document 1 discloses a sensor-equipped guidewire having a sensor attached to a distal end and a hollow connector at a proximal end for connection to an external device. At the proximal end of this sensor-equipped guidewire, wiring electrically connecting the sensor and the connector is disposed inside the connector and electrically connected to the connector.

[0003] Japanese Patent Application Laid-Open No. 2020-161223

[0004] At the proximal end of a sensor-equipped guidewire, the core wire and wiring constituting the guidewire may be disposed inside a hollow connector. In this case, if the relative position of the connector to the core wire changes and the wiring is repeatedly pinched between the outer circumferential surface of the core wire and the inner circumferential surface of the connector, there is a risk of damage to the wiring. For this reason, there has been a demand for a method to prevent damage to the wiring caused by being pinched between the core wire and the connector. Note that Patent Document 1 does not take into consideration the possibility of damage to the wiring caused by being pinched between the core wire and the connector.

[0005] The present invention has been made to solve at least some of the above-mentioned problems, and aims to provide a technology that prevents damage to wiring in a sensor-equipped guide wire caused by it being pinched between a core wire and a hollow electrode.

[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 comprising: a core wire, a sensor disposed at a distal end of the core wire, a main lead wire electrically connected to the sensor and extending along the core wire to a proximal end of the core wire, a hollow electrode disposed at the proximal end of the core wire and containing the core wire and the main lead wire, and a connecting member connecting the core wire, the main lead wire, and the hollow electrode inside the hollow electrode, wherein the connecting member covers at least a portion of the main lead wire in a first region inside the hollow electrode, electrically connecting the main lead wire and the hollow electrode and connecting the core wire and the hollow electrode in an insulated state.

[0008] According to this configuration, the main lead wire and the hollow electrode are electrically connected in the first region. Therefore, when the hollow electrode is connected to an external device that processes an output signal from the sensor, the output signal from the sensor can be transmitted to the external device via the main lead wire and the hollow electrode. Furthermore, according to this configuration, the core wire and the hollow electrode, and the core wire and the main lead wire, are connected in an insulated state in the first region. This prevents the relative position of the hollow electrode with respect to the core wire from changing. This prevents damage to the main lead wire caused by being pinched between the core wire and the hollow electrode whose relative positions have changed. Furthermore, since the core wire is insulated from the hollow electrode and the main lead wire in the first region, transmission of the output signal from the sensor to the core wire can also be prevented.

[0009] (2) The sensor-equipped guidewire of the above embodiment may further include an auxiliary lead wire electrically connected to the sensor, extending along the core wire to a proximal end of the core wire, with the proximal end located inside the hollow electrode, wherein the auxiliary lead wire is spaced from the main lead wire in the first region, and the connecting member connects the spaced-apart main lead wire and auxiliary lead wire to the core wire and the hollow electrode, and the auxiliary lead wire is integrated with the main lead wire in a second region inside the hollow electrode, different from the first region, and the connecting member connects the integrated main lead wire and auxiliary lead wire to the core wire and the hollow electrode. When the auxiliary lead wire is integrated with the main lead wire, the portions of the outer circumferential surfaces of the main lead wire and the auxiliary lead wire that are in contact with each other are not exposed to the outside. On the other hand, when the auxiliary lead wire is spaced from the main lead wire, the entire outer circumferential surfaces of the main lead wire and the auxiliary lead wire are exposed to the outside. Therefore, with this configuration, the main lead wire and the auxiliary lead wire separated in the first region can have a larger connection area on each of the outer surfaces of the main lead wire and the auxiliary lead wire, where the connecting member can be connected, compared to the integrated main lead wire and the auxiliary lead wire. Therefore, the connection strength between the main lead wire and the auxiliary lead wire and the core wire and the hollow electrode can be increased in the first region. Meanwhile, in the second region, even if the connection between the main lead wire and the auxiliary lead wire and the core wire and the hollow electrode is severed due to peeling of the connecting member or the like, the integrated main lead wire and the auxiliary lead wire can prevent the main lead wire and the auxiliary lead wire from becoming entangled.

[0010] (3) In the sensor-equipped guide wire of the above aspect, the auxiliary lead wire may be integrated with the main lead wire in a third region inside the hollow electrode, the third region being located on a side separated from the first region by the second region, and the connecting member may connect the integrated main lead wire and auxiliary lead wire to the core wire and the hollow electrode. With this configuration, as in the second region, in the third region as well, when the main lead wire and auxiliary lead wire are disconnected from the core wire and the hollow electrode, entanglement of the main lead wire and the auxiliary lead wire can be suppressed.

[0011] (4) In the sensor-equipped guidewire of the above embodiment, the connecting member may cover at least half of the outer circumference of the cross section of the main lead wire in the first region inside the hollow electrode. This configuration makes it difficult for the connecting member to peel off from the main lead wire. Therefore, it is possible to prevent the disconnection between the main lead wire and the core wire or the main lead wire and the hollow electrode due to the connecting member peeling off from the main lead wire.

[0012] 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.

[0013] FIG. 1 is an explanatory diagram illustrating the configuration of a sensor-equipped guidewire of a first embodiment; FIG. 2 is an enlarged view of a connector assembly; FIG. 3 is an explanatory diagram of details of a connector assembly, a core wire, and a cable; FIG. 4 is a cross-sectional view showing each cross section of a proximal end portion of a sensor-equipped guidewire; FIG. 5 is an enlarged cross-sectional view of a sensor assembly; FIG. 6 is an explanatory diagram for explaining details of the configuration of a tubular member; FIG. 7 is an explanatory diagram for explaining details of the configuration of a sensor sheet; FIG. 8 is an explanatory diagram for explaining the process of winding the sensor sheet around a tubular member; FIG. 9 is an explanatory diagram of details of a cable arranged between a first section and a second section; FIG. 10 is an explanatory diagram showing a schematic configuration of a sensor-equipped guidewire of a second embodiment; FIG. 11 is an enlarged view of the periphery of a sensor assembly; FIG. 12 is an explanatory diagram showing a schematic configuration of a sensor-equipped guidewire of a third embodiment; FIG. 13 is a cross-sectional view showing a cross section of a sensor-equipped guidewire of a fourth embodiment; FIG. 14 is an explanatory diagram showing a schematic configuration of a sensor-equipped guidewire of a fifth embodiment.

[0014] First Embodiment Fig. 1 is an explanatory diagram illustrating the cross-sectional configuration of a sensor-equipped guidewire 1 according to a first embodiment. In Fig. 1, a sensor assembly 20 and a connector assembly 40 are shown in external appearance. The sensor-equipped guidewire 1 according to 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.

[0015] 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. Also, FIG. 1 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 (+X axis direction) of FIG. 1 is referred to as the "distal side" of the sensor-equipped guidewire 1 and each component, and the left side (-X axis direction) of FIG. 1 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 portion located on the distal side and its vicinity will be referred to as the "distal portion" or simply the "distal portion," and the end portion 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.

[0016] 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 thin distal portion 11, a tapered portion 12, a thick portion 13, a reduced diameter portion 14, and a thin proximal portion 15.

[0017] 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 proximal 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 has a generally cylindrical shape with a generally constant outer diameter, where the outer diameter of the core wire 10 is smaller than that of the thick section 13. The outer diameters, lengths in the axial direction O, and cross-sectional shapes of the distal thin section 11, tapered section 12, thick section 13, reduced diameter section 14, and proximal thin section 15 can be determined arbitrarily.

[0018] 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 bodily 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.

[0019] The cable 30 has five lead wires 32a-e (see FIGS. 3C and 9A-B) extending along the core wire 10 to the proximal 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 in FIGS. 3 and 9. Note that "electrically connected" means connected in a state in which current can flow (conductive state).

[0020] 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.

[0021] Furthermore, as shown in Figure 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.

[0022] 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, a metal solder such as silver solder, gold solder, zinc, an Sn—Ag alloy, or an Au—Sn alloy, or an adhesive such as an epoxy adhesive.

[0023] The first coil body 60 and the second coil body 70 are flexible, generally cylindrical coil bodies having a generally constant outer diameter from the base end to the tip end. 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.

[0024] 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 preferably has antithrombogenicity, flexibility, and biocompatibility, and can be formed from a resin material or a 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 the second coil body 70 may be coated with a hydrophilic or hydrophobic resin.

[0025] 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.

[0026] 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, includes 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 connecting members 43a-e, and occlusion members 45a-e.

[0027] 3A and 3B are explanatory diagrams illustrating the connector assembly 40 and the core wire 10 and cable 30 contained therein in detail. FIG. 3A shows a structure 40p obtained by removing the blocking members 45a-e from the connector assembly 40. Specifically, 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 includes the core wire 10 and the cable 30 therein (see FIG. 2). The hollow electrodes 41a-e are arranged in the following order from the distal end to the proximal end: 41a, 41b, 41c, 41d, and 41e. 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.

[0028] 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. Therefore, when the connector assembly 40 is bent, the load is likely to be applied mainly to the inter-ring joint members 43a-e and is less likely to be applied to the highly rigid hollow electrodes 41a-e.

[0029] 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.

[0030] FIG. 3C shows the portion of the cable 30 disposed inside the connector assembly 40. The five lead wires 32a-e constituting the cable 30 are arranged in the order of lead wires 32a, 32b, 32c, 32d, and 32e from the +Y axis direction to the −Y axis direction (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 covering the core wire 10. As shown in FIG. 3C, the portions of the insulating tubes 36a-e disposed inside the connector assembly 40 are integrated by fusion-bonding their outer peripheries. That is, in the portion of the cable 30 that is disposed inside the connector assembly 40, the lead wires 32a-e are integrated with one another, with the exception of a small portion. Also, as shown in Figure 3C, 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 away, exposing the core wires 34a-e. This exposed portion corresponds to the non-integrated portion.

[0031] 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 these through-holes 42a-e are blocked by the blocking members 45a-e is the state shown in Fig. 2.

[0032] FIG. 4 shows cross-sectional views of the proximal end of the sensor-equipped guidewire 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, exposing the core wire 34d. Therefore, 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, different from the first region R1, where the core wire 34d covered with the insulating tube 36d is arranged in the X-axis direction. That is, the cross section shown in 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, separated from the second region R2 by the first region R1, where the core wire 34d covered with the insulating tube 36d is arranged in the X-axis direction, similar to the second region R2.

[0033] As shown in Figures 4(A) to 4(C), 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. Also, as shown in Figure 4(A), 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 consists 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. 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.

[0034] As shown in FIG. 4A, 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. 4B, 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 are fused together at their outer circumferential surfaces, as described 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 also the same 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.

[0035] In the 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 the second region R2 inside the hollow electrode 41d, correspond to the "secondary lead wire." Furthermore, inside the hollow electrodes 41a-c, 41e, there are first to third regions similar to the inside of 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.

[0036] 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.

[0037] FIG. 6 is an explanatory diagram illustrating 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.

[0038] 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 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 wider than the narrow portion 24b. A sensor array 24s is disposed 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 bodily fluids, such as blood, flowing through blood vessels. The narrow portion 24b is a strip-shaped portion narrower than the wide portion 24a and is connected to the wide portion 24a. Two microchips 24m connected to the sensor array 24s are disposed 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.

[0039] 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 slits 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). The wide portion 24a is then 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.

[0040] Returning to the description 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 bonding member 25. The distal bonding member 25 bonds 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 together. Similar to the intermediate bonding member 75 and the proximal bonding member 85, any bonding agent can be used for the distal bonding member 25.

[0041] In this 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. Also, as shown in Fig. 5 , 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. The outer diameter L2 is the maximum outer diameter of 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 (proximal end tubular portion 22a) of the tubular member 22 is disposed inside the distal end of the second coil body 70, and the base end (proximal end tubular portion 22a) of the tubular member 22 is joined to the distal end of the second coil body 70. Also, as shown in FIG. 5, 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.

[0042] 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).

[0043] 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 end portions 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.

[0044] FIG. 9 is an explanatory diagram illustrating the details of the 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 referred to as the 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 outer surfaces of the insulating tubes 36a-e are not fused to each other but are spaced apart, allowing the lead wires 32a-e to move freely without following each other's movements. 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), so the lead wires 32a-e are arranged in a bent state between the portions. On the other hand, 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 to the base end of the second section S2, the lead wires 32a-e are integrated except for a portion, as described in Fig. 3(C).

[0045] 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 included within the intermediate joint member 75, the cable 30 is joined to the core wire 10 at the intermediate position MP. 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, but 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 it.

[0046] In this embodiment, the lead wires 32a to 32e are all equal in 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 to 32e differ from one another within a predetermined error range, they are still considered to be equal.

[0047] 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 all 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.

[0048] As described above, according to the sensor-equipped guidewire 1 of the first embodiment, as shown in FIGS. 4A and 4C , the lead wire 32d and the hollow electrode 41d are electrically connected in the first region R1. Therefore, when the hollow electrode 41d is connected to an external device that processes the 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. 4A and 4C , 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. 4A and 4C , 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 prevents the relative position of the hollow electrode 41d with respect to the core wire 10 from changing. This prevents damage to the lead wire 32d caused 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 also prevents the output signal from the sensor array 24s from being transmitted to the core wire 10. The configuration and effects described here are the same in the first region inside the hollow electrodes 41a-c, e.

[0049] 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 that are in contact with the outer circumferential surfaces of the lead wires 32c and 32e 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 Figures 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 the lead wire 32d is integrated with the lead wires 32c and 32e in the second region R2. Therefore, in the first region R1, the separated lead wire 32d and the lead wires 32c, 32e have a larger connection area on the outer circumferential surface of the lead wire 32d and the outer circumferential 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, the integrated lead wires 32d and the lead wires 32c, 32e can be prevented from becoming entangled. 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 are also applicable to the first and second regions inside the hollow electrodes 41a-c and 41e.

[0050] Furthermore, in the sensor-equipped guidewire 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, in the third region R3, entanglement of the lead wires 32d and 32c and 32e can be prevented when the connection between the lead wires 32d and 32c and 32e and the core wire 10 and the hollow electrode 41d is severed. Also 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, the 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 are also applicable to the third region inside the hollow electrodes 41a-c and 41e.

[0051] 4A, in the sensor-equipped guide wire 1 of the first embodiment, the connecting member 47 covers the entire outer periphery of the cross section (YZ cross section) of the lead wire 32d in the first region R1. This makes it difficult for the connecting member 47 to peel off from the lead wire 32d. This prevents 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 are also applicable to the first region inside the hollow electrodes 41a-c and e.

[0052] 5 , in the sensor-equipped guidewire 1 of the first embodiment, the distal end (tip tubular portion 22 c) of the tubular member 22 is disposed inside the proximal end of the first coil body 60, and the distal end (tip tubular portion 22 c) 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. The first coil body 60 forms the outer shape of the distal end of the sensor-equipped guidewire 1, and therefore 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, 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 transmission at the distal end of the sensor-equipped guidewire 1, thereby improving the operability of the sensor-equipped guidewire 1.

[0053] 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.

[0054] 5 , in the sensor-equipped guidewire 1 of the first embodiment, 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 is joined to the proximal end of the second coil body 70. This prevents the central axis of the tubular member 22 from shifting from the central axis of the second coil body 70. The second coil body 70 constitutes part of the outer shape of the sensor-equipped guidewire 1, and therefore 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.

[0055] 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.

[0056] Furthermore, in the sensor-equipped guidewire 1 of the first embodiment, in the cable 30 (see FIG. 1) arranged between the proximal end of the first section S1 and the intermediate position MP, the lead wires 32a-e are not integrated and are capable of relative movement, as shown in FIG. 9A. Therefore, the lead wires 32a-e can move freely between the proximal end of the first section S1 and the intermediate position MP without following each other's movements, thereby ensuring flexibility at the distal end of the sensor-equipped guidewire 1. Furthermore, in the sensor-equipped guidewire 1 of the first embodiment, in the cable 30 (see FIG. 1) arranged between the intermediate position MP and the distal end of the second section S2, the lead wires 32a-e are integrated, as shown in FIG. 9B. 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 of the sensor-equipped guidewire 1 on the proximal side of 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, as it is possible to achieve both flexibility at the tip end and operability at the base end.

[0057] 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 being caught on the second coil body 70 and pulling on the core wire 10, thereby preventing the core wire 10 from becoming bent. This is because, for example, even if one of the non-integrated lead wires 32a-e is caught on the second coil body 70, it is unlikely to generate a pulling force strong enough to cause the core wire 10 to become bent. Furthermore, by being arranged in a bent state, the non-integrated lead wires 32a-e can be prevented from being broken when the sensor-equipped guide wire 1 is rotated or inserted into a bent section.

[0058] 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 capable of relative movement. 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 ensured flexibility on the distal end side.

[0059] 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 of the intermediate position MP from being pulled by the unintegrated lead wires 32a-e on the distal side of the intermediate position MP, causing the integrated lead wires 32a-e on the proximal side of the intermediate position MP to be pulled apart. In other words, the intermediate position MP serves as 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.

[0060] 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 and 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 sum of the lengths of the lead wires 32a-c and e and the excess length. The longer this excess length is, the higher the likelihood that the lead wire 32d will become entangled with the lead wires 32a-c and 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, thereby reducing the likelihood that the lead wires 32a-e will become entangled with each other or with the core wire 10.

[0061] 10 is an explanatory diagram showing the schematic configuration of a sensor-equipped guidewire 1A of a 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.

[0062] 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.

[0063] 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 bonding member 64 bonds the first coil body 60 to the inner coil body 62. The second tip bonding member 66 bonds the proximal end of the inner coil body 62 to the core wire 10. As with the distal bonding member 25, the intermediate bonding member 75, and the proximal bonding member 85, any bonding agent may be used for the first tip bonding member 64 and the second tip bonding member 66. For example, a brazing material or adhesive made of silver, tin, copper, or the like may be used for the first tip bonding member 64 and the second tip bonding member 66.

[0064] The sensor-equipped guidewire 1A of the second embodiment 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 (tip tubular portion 22c) of the tubular member 22 and the core wire 10, which can prevent the tubular member 22 from shifting relative to the core wire 10. In other words, it can prevent the central axis of the tubular member 22 from shifting from the central axis of the core wire 10. This improves the torque transmission of the sensor-equipped guidewire 1A, thereby further improving operability.

[0065] 12 is an explanatory diagram showing a schematic configuration of a sensor-equipped guidewire 1B of a 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.

[0066] 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. However, 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 positioned 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.

[0067] 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.

[0068] <Fourth Embodiment> Fig. 13 is a cross-sectional view showing a cross section of a sensor-equipped guidewire 1C of a 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 regions inside the hollow electrodes 41a-e (regions in which the exposed core wires 34a-e are arranged in the X-axis direction) and in that the hollow electrodes 41a-e do not have through holes 42a-e.

[0069] 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 located 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 located inside the hollow electrode 41d, and the remaining portion is located inside the inter-ring joint member 43d. The portion of the core wire 34d exposed in the X-axis direction that is located 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. Note that, although the arrangement of the first region R1 is different, the conductive connecting member 47c is arranged 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.

[0070] The sensor-equipped guidewire 1C of the fourth embodiment 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 the through-holes 42a-e are not formed in the hollow electrodes 41a-e, it is possible to provide a sensor-equipped guidewire 1C that includes a highly rigid connector assembly 40.

[0071] 14 is an explanatory diagram showing the schematic configuration of a sensor-equipped guidewire 1D of a 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.

[0072] 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, like the tube 80, is a substantially cylindrical tube having a substantially constant outer diameter from the proximal end to the distal end. The proximal tube 90 is formed of a material that is stronger than the tube 80. A tube connecting member 95 connects the tube 80 and the proximal tube 90.

[0073] The sensor-equipped guidewire 1D of the fifth embodiment described above can also achieve the same effects as those of the first embodiment. 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, and therefore it is possible to provide a sensor-equipped guidewire 1D with improved operability on the proximal side.

[0074] <Modifications of this embodiment> The present invention is not limited to the above-described embodiment, and can be implemented in various forms without departing from the spirit of the present invention. For example, the following modifications are also possible.

[0075] [Modification 1] In the first to fifth embodiments, the configurations of the sensor-equipped guidewires 1 and 1A to 1D have been illustrated. However, various modifications to the configuration of the sensor-equipped guidewire are possible. For example, while the sensor-equipped guidewires 1 and 1A to 1D each include a sensor that measures the electrical resistance of a bodily fluid such as blood flowing within a blood vessel, this is not limiting. For example, the sensor-equipped guidewire may include 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). The fractional flow reserve is the pressure behind the stenosis relative to the pressure ahead of the stenosis, and can be used as an index of physiological stenosis severity.

[0076] 3C , 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 in which the core wires 34a-e are exposed by being peeled off the entire circumference, but this is not limited to this. For example, each of the insulating tubes 36a-e may be an exposed portion in which 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).

[0077] 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, the connecting member 47 may be disposed with gaps inside the hollow electrode 41d, or the connecting member 47 may be disposed independently in each of the first to third regions R1 to R3, without being connected among them. 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 composed of only 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 (Y-Z cross section) of the core wire 34d, but the present invention is not limited to this, and 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 (Y-Z cross section) of the core wire 34d to the hollow electrode 41d.

[0078] 2, in the above-described embodiment, the hollow electrodes 41a-e are each formed with a through hole 42a-e, but the number of through holes is not limited to one, and two or more through holes may be formed in each of the hollow electrodes 41a-e. Furthermore, when two or more through holes are formed, the insulating tubes 36a-e may be peeled off to expose the core wires 34a-e in the same number as the number of through holes, and these may be arranged inside the respective through holes.

[0079] [Variation 5] 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. However, the present invention is not limited to this, and the sensor does not have to be a sheet-like member, and may be attached to the tubular member 22 by any method 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.

[0080] [Variation 6] 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 be connected inside the tubular member 22.

[0081] [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.

[0082] [Variation 8] In the above embodiment, 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 that section (between the base end of the first section S1 and the intermediate position MP) are not integrated, 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.

[0083] [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. Alternatively, 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.

[0084] [Modification 10] In the above-described embodiment, the lead wires are integrated by fusing the outer circumferential surfaces of the insulating tubes together as described with reference to Fig. 3C and Fig. 9, 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.

[0085] [Modification 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 proximal joint member 85. However, this is not limiting. 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 proximal joint member 85.

[0086] [Modification 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.

[0087] [Modification 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.

[0088] [Modification 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 to 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 through-holes 42a-e may not be formed in the hollow electrodes 41a-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.

[0089] 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.

[0090] DESCRIPTION OF SYMBOLS 1, 1A to 1D... Guide wire 10... Core wire 11... Distal end thin diameter section 12... Tapered section 13... Large diameter section 14... Reduced diameter section 15... Proximal end thin diameter section 16... Insulating tube 20, 20a... Sensor assembly 22... Tubular member 22a... Proximal end tubular section 22b... Intermediate connection section 22c... Distal end tubular section 22s... Slit 24... Sensor sheet 24a... Widened section 24b... Narrowed width section 24c... Sensor wiring 24m... Microchip 24s... Sensor array 25, 25a... Distal side joining member 26... Spacer 30... Cable 32a to e... Lead wire 34a to e... Core wire 36a to e... Insulating tube 40... Connector assembly 40p... Structure 41a to e... Hollow electrode 42a to e... Through hole 43a-e...Inter-ring connecting member 43a-e...Blocking member 45a-e...Closure member 47...Connecting member 47c...Conductive connecting member 47i...Insulating connecting member 50...Distal tip 60...First coil body 62...Inner coil body 64...First distal end connecting member 66...Second distal end connecting member 70...Second coil body 75...Intermediate connecting member 77...First intermediate connecting member 79...Second intermediate connecting member 80...Tube 85...Proximal end side connecting member 90...Proximal end tube 95...Tube connecting member

Claims

1. A sensor-equipped guidewire, A core wire; A sensor disposed at a distal end of the core wire; a main lead electrically connected to the sensor and extending along the core wire to a proximal end of the core wire; a hollow electrode disposed at a proximal end of the core wire and including the core wire and the main lead wire therein; a connecting member that connects the core wire, the main lead wire, and the hollow electrode inside the hollow electrode; Equipped with The connection member is provided in a first region inside the hollow electrode. a covering for covering at least a portion of the main lead wire, electrically connecting the main lead wire and the hollow electrode; The sensor-equipped guide wire comprises a core wire and a hollow electrode, and a core wire and a main lead wire, which are connected in an insulated state.

2. 2. The sensor-equipped guidewire according to claim 1, further comprising: a secondary lead wire electrically connected to the sensor, extending along the core wire to a proximal end of the core wire, the proximal end being disposed inside the hollow electrode; In the first region, the secondary lead is spaced apart from the primary lead, the connecting member connects the spaced apart main lead wire and sub-lead wire, the core wire, and the hollow electrode; In a second region different from the first region inside the hollow electrode, The secondary lead wire is integrated with the main lead wire, The connecting member connects the integrated main lead wire and auxiliary lead wire, the core wire, and the hollow electrode.

3. The sensor-equipped guidewire according to claim 2, In a third region on a side of the hollow electrode that is spaced apart from the second region by the first region, The secondary lead wire is integrated with the main lead wire, The connecting member connects the integrated main lead wire and auxiliary lead wire, the core wire, and the hollow electrode.

4. A sensor-equipped guidewire as described in claim 2 or claim 3, further comprising: a lead wire different from the main lead wire and the secondary lead wire, the lead wire being electrically connected to the sensor, extending along the core wire to a proximal end of the core wire, the proximal end being disposed inside the hollow electrode; In the first region, At least one of the lead wires is integrated with the secondary lead wire, The connecting member connects the integrated auxiliary lead wire and lead wire, the core wire, and the hollow electrode.

5. The sensor-equipped guidewire according to any one of claims 1 to 3, In the first region inside the hollow electrode, The connecting member covers at least half of the outer circumference of the cross section of the main lead wire.