Medical device

Abstract

A medical device has a long main body and a leading portion. The main body has a conductive wire, an electrical element having a first electrode and a second electrode, a signal line electrically connected to the first electrode, and a connecting portion electrically connecting the second electrode and the wire. The leading portion is connected to the front end of the main body and enters a lesion.

Description

Technical Field

[0001] The technology disclosed in this specification relates to medical devices. Background Technology

[0002] To treat narrowed or occluded sections of a blood vessel (hereinafter referred to as "lesions"), the surgeon inserts a guidewire into the blood vessel and guides it to the lesion within the vessel. Known guidewires have an ultrasound sensor at their tip, allowing the ultrasound sensor to monitor the condition of the blood vessel (see, for example, Patent Documents 1 and 2).

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Publication No. 2015-529522

[0006] Patent Document 2: Japanese Patent Application Publication No. 11-244248 Summary of the Invention

[0007] The problem that the invention aims to solve

[0008] The aforementioned known guidewires have a pair of signal lines connected to a pair of electrodes of an ultrasound sensor. Therefore, the presence of these signal lines can lead to reduced guidewire performance or limitations on the guidewire's structure. This issue is not limited to guidewires with ultrasound sensors inserted into blood vessels, but is a common problem in medical devices with electrical components inserted into the lumen of a living organism.

[0009] This specification discloses a technique that can solve the above-mentioned problems.

[0010] Solution for solving the problem

[0011] The medical device disclosed in this specification comprises an elongated main body and a leading portion. The main body has a conductive wire, an electrical component having a first electrode and a second electrode, a signal line electrically connected to the first electrode, and a connecting portion electrically connecting the second electrode to the conductive wire. The leading portion is connected to the front end of the main body and enters the lesion. Attached Figure Description

[0012] Figure 1 This is an explanatory diagram that schematically shows the structure of the guide wire 100 in this embodiment.

[0013] Figure 2 This is an explanatory diagram that schematically shows the structure of the guide wire 100 in this embodiment.

[0014] Figure 3 This is an explanatory diagram that schematically shows the structure of the guide wire 100 in this embodiment.

[0015] Figure 4 This is an explanatory diagram that schematically shows the structure of the guide wire 100 in this embodiment.

[0016] Figure 5 This is an explanatory diagram that schematically shows the structure of the guide wire 100 in this embodiment.

[0017] Figure 6 This is an explanatory diagram showing the peripheral structure of the ultrasonic sensor 70 in the guide wire 100.

[0018] Figure 7 This is an explanatory diagram showing the peripheral structure of the ultrasonic sensor 70 in the guide wire 100. Detailed Implementation

[0019] (Basic structure of guidewire 100)

[0020] Figures 1 to 5 This is an explanatory diagram that schematically illustrates the structure of the guidewire 100 in this embodiment. Figure 1 This indicates the appearance of the guidewire 100 when viewed from the X-axis direction. Figure 2 This indicates the appearance of the guidewire 100 when viewed from the Y-axis direction. Figure 3 This indicates the appearance of the guidewire 100 when viewed from the Z-axis direction. Figure 4 This is a three-dimensional view of the front end of guidewire 100. Figure 5 This shows the YZ longitudinal section of guidewire 100. In guidewire 100, the positive Z-axis side is the distal end (distal side) inserted into the body, and the negative Z-axis side is the proximal end (proximal side) manipulated by the surgeon. Sometimes, a portion of guidewire 100 is omitted from the illustrations. Figure 1 , 2 Figure 5 shows the guidewire 100 in a straight line parallel to the Z-axis. The guidewire 100 has a degree of flexibility capable of bending. These points are also shown in subsequent figures.

[0021] In this specification, regarding the guidewire 100 and its constituent components, the end on the front end side is referred to as the "front end," the front end and its vicinity as the "front end portion," the end on the base end side is referred to as the "base end," and the base end and its vicinity as the "base end portion." The cross-section of the guidewire 100 and its constituent components refers to a section orthogonal to the length direction. The longitudinal section of the guidewire 100 and its constituent components refers to a section parallel to the central axis of the length direction. Regarding the guidewire 100 and its constituent components, the direction orthogonal to the length direction is referred to as the radial direction. The outer diameter of the guidewire 100 and its constituent components refers to the width along the radial direction.

[0022] The guidewire 100 is a long, thin medical device that is inserted into a blood vessel. The total length of the guidewire 100 is, for example, more than 1000 mm and less than 3000 mm.

[0023] The guidewire 100 has a main body 10 and a leading part 20.

[0024] The main body 10 is an elongated section extending along the central axis Ax. In this embodiment, the central axis Ax of the main body 10 coincides with the central axis of the guide wire 100. The base end 15 of the main body 10 coincides with the base end of the guide wire 100. A spiral groove 18 is formed on a portion of the outer peripheral surface 17 of the front end of the main body 10.

[0025] The leading portion 20 is connected to the front end 16 of the main body 10. The leading portion 20 can function as a guide, drill bit, fragmentation section, peeling section, intrusion section, peeler, vibrator, etc. The front end 23 of the leading portion 20 coincides with the front end of the guide wire 100. The leading portion 20 is annular, surrounding the through hole 24 extending along the X-axis. The surface of the leading portion 20 may or may not have edges. An edge refers to the boundary (ridge line) between two surfaces. The leading portion 20 enters the lesion while rotating around the central axis Ax. The leading portion 20 crosses (passes through) the lesion. The leading portion 20 entering the lesion is drilling the lesion. The leading portion 20 entering the lesion means breaking up the lesion. The leading portion 20 entering the lesion is peeling the lesion. The leading portion 20 entering the lesion means separating the lesion. The leading portion 20 entering the lesion is penetrating the lesion. The lead portion 20 entering the lesion is considered an invasion of the lesion. The length L20 of the lead portion 20 along the central axis Ax is, for example, 0.2 mm or more and 2.0 mm or less. The length L20 of the lead portion 20 can be 0.3 mm or more and 1.5 mm or less, or 0.4 mm or more and 1.0 mm or less.

[0026] During treatment using guidewire 100, the leading portion 20 of guidewire 100 is inserted into the lesion within the blood vessel. The lesion may be, for example, a highly calcified lesion or a chronically obstructive lesion.

[0027] The surgeon inserts a guidewire 100 into a catheter inserted into a blood vessel, with the guidewire 100 at the tip 20, and advances the guidewire 100 to the proximal end of the lesion in the blood vessel. Then, the surgeon advances the guidewire 100 towards the anterior end while rotating it, thereby advancing the guidewire 100 into the lesion. If the surgeon holds the base of the guidewire 100 and rotates it about the central axis Ax, the guidewire 20 at the tip of the guidewire 100 also rotates about the central axis Ax. The rotating guidewire 20 excavates by cutting through the lesion. In this embodiment, the surgeon advances the guidewire 20 until it passes through the lesion. If the guidewire 20 has an edge, rotating the guidewire 20 about the axis with the edge against the lesion cuts through the lesion. The guidewire 20 penetrates the space formed by cutting through the lesion with the edge, thereby forming a through-hole in the lesion. As described above, a spiral groove 18 is formed on the outer peripheral surface 17 of the front end of the main body 10. Due to the presence of this groove 18, the main body 10 has the function of discharging small fragments of the lesion caused by the contact between the rotating guide portion 20 and the lesion from the front end side of the main body 10 toward the base end side (hereinafter referred to as "lesion discharge function"). When the guide portion 20 is inserted into the lesion, the surgeon can switch the rotation direction of the guidewire 100 to a first rotation direction RD1 and a second rotation direction RD2 opposite to the first rotation direction RD1. Alternatively, the surgeon can fix the rotation direction of the guidewire 100 to either the first rotation direction RD1 or the second rotation direction RD2. In this embodiment, the lesion passage when the guidewire 100 is rotated in the first rotation direction RD1 is different from the lesion passage when the guidewire 100 is rotated in the second rotation direction RD2. The surgeon can select the rotation direction of the guidewire 100 according to the desired lesion passage. After the guidewire 100's leading portion 20 passes through the lesion, the surgeon can use devices such as abdominal treatment equipment, balloon catheters, or stents to perform treatment.

[0028] (Detailed structure of guidewire 100)

[0029] like Figure 5 As shown, the guide wire 100 has a conductor 40, a first outer coil 50, a second outer coil 55, and an inner coil 90. Hereinafter, the first outer coil 50 and the second outer coil 55 will be collectively referred to as outer coils 50 and 55, and the outer coils 50 and 55 and the inner coil 90 will be collectively referred to as coils 50, 55, and 90.

[0030] Conductor 40 is a linear component. For example... Figure 5 As shown, the conductor 40 has a large diameter portion 41, a first tapered portion 42, an intermediate diameter portion 43, a second tapered portion 44, a first small diameter portion 47, and a second small diameter portion 48.

[0031] The thick-diameter portion 41 of the conductor 40 is a rod-shaped portion with a substantially constant outer diameter. The outer diameter (maximum width) of the thick-diameter portion 41 is, for example, approximately 0.2 mm to 3.0 mm. The intermediate-diameter portion 43 is located near the front end of the thick-diameter portion 41 and is a rod-shaped portion with a substantially constant outer diameter smaller than the outer diameter of the thick-diameter portion 41. The first tapered portion 42 is located between the thick-diameter portion 41 and the intermediate-diameter portion 43, and its diameter gradually decreases from the boundary with the thick-diameter portion 41 towards the boundary with the intermediate-diameter portion 43. The first thin-diameter portion 47 is located near the front end of the intermediate-diameter portion 43 and is a rod-shaped portion with a substantially constant outer diameter smaller than the outer diameter of the intermediate-diameter portion 43. The second tapered portion 44 is located between the intermediate-diameter portion 43 and the first thin-diameter portion 47, and its diameter gradually decreases from the boundary with the intermediate-diameter portion 43 towards the boundary with the first thin-diameter portion 47. In this embodiment, the second tapered portion 44 includes a base-end side second tapered portion 45 and a front-end side second tapered portion 46 located closer to the front end than the base-end side second tapered portion 45. The second narrow-diameter portion 48 is a rod-shaped portion having a substantially constant outer diameter.

[0032] The first narrow diameter portion 47 of the conductor 40 extends from the boundary with the second tapered portion 46 on the front end side toward the front end side to the front end 23 of the guide wire 100. The second narrow diameter portion 48 extends from the front end 23 of the guide wire 100 toward the base end side. That is, in the conductor 40, the second narrow diameter portion 48 is folded back toward the base end side. The position of the base end of the second narrow diameter portion 48 is, for example, closer to the front end side than the boundary between the second tapered portion 45 on the base end side and the second tapered portion 46 on the front end side, and closer to the base end side than the boundary between the second tapered portion 46 on the front end side and the first narrow diameter portion 47. Hereinafter, the portion of the conductor 40 that is folded back toward the base end side is referred to as the folded-back portion 40A, and the portion of the conductor 40 other than the folded-back portion 40A is referred to as the base portion 40B. The folded-back portion 40A is constituted by the second narrow diameter portion 48. The base portion 40B is constituted by the portion of the conductor 40 other than the second narrow diameter portion 48. In this embodiment, the fold-back portion 40A and the base portion 40B do not contact each other radially, and there is a gap between them.

[0033] The shape of the cross-section at each location of the conductor 40 can be any shape. The cross-section shape at each location of the conductor 40 can also be circular, partially circular (e.g., semicircular, incomplete circular, arc-shaped), elliptical, rectangular, parallelogram, trapezoidal, rhomboid, etc. The cross-section of the conductor 40 is not limited to the strictly described shapes, but can also be approximately the above shapes. The shape of the cross-section can also be different at each location along the length of the conductor 40.

[0034] The conductor 40 is formed of a conductive material. For example, a metal can be used as the material forming the conductor 40. More specifically, stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloy, piano wire, etc., can be used. The conductor 40 can be formed entirely of the same material, or each part can be formed of different materials.

[0035] Coils 50, 55, and 90 are cylindrical components formed by winding one or more wires into a spiral shape. The wires constituting coils 50, 55, and 90 can be made of a single wire or a stranded wire composed of multiple wires twisted together. Coils 50, 55, and 90 can have a constant outer diameter along their entire length, or they can be conical in shape with the outer diameter gradually decreasing from the base to the front end, or conical in shape with the outer diameter gradually decreasing from the front end to the base end.

[0036] The inner coil 90 is configured to cover a portion of the conductor 40 from the outside. For example, the inner coil 90 covers a portion of the second tapered portion 44 in the conductor 40.

[0037] The outer coils 50 and 55 are arranged radially outward from the inner coil 90, covering a portion of the conductor 40 from the outside. The front end 51 of the first outer coil 50 coincides with the front end 16 of the main body 10. The second outer coil 55 is arranged at a distance from the first outer coil 50 at the base end side. For example, the first outer coil 50 covers a portion of the first narrow diameter portion 47 and the second narrow diameter portion 48 in the conductor 40, and the second outer coil 55 covers a portion of the second tapered portion 44 in the conductor 40. Spiral grooves 53 and 57 are formed on the outer peripheral surfaces 52 and 56 of the outer coils 50 and 55. Due to the presence of the spiral grooves 53 and 57, a spiral groove 18 is formed on the outer peripheral surface 17 of the main body 10.

[0038] The materials used to form coils 50, 55, and 90 may be metals, for example. More specifically, materials such as stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloys, piano wire (radiotransmissive materials), platinum, gold, tungsten, and their alloys (radioimpermissive materials) may be used. Coils 50, 55, and 90 may be formed entirely of the same material, or each part may be formed of different materials. Coils 50, 55, and 90 may each be formed of the same material or different materials.

[0039] Coils 50, 55, and 90 are joined to conductor 40. For example, the first outer coil 50 is joined to conductor 40 via a front end-side joint 61 formed at the front end of the first outer coil 50. The second outer coil 55 is joined to conductor 40 via a base end-side joint 62 formed at the base end of the second outer coil 55. The inner coil 90 is joined to conductor 40 via a front end-side joint 91 formed at the front end of the inner coil 90 and a base end-side joint 92 formed at the base end of the inner coil 90. Coils 50, 55, and 90 may also be joined to conductor 40 via joints formed at other locations. Materials used for forming these joints include, for example, metal solder (Au-Sn alloy, Sn-Ag alloy, Sn-Pb alloy, Pb-Ag alloy, etc.), solder (aluminum alloy solder, silver solder, gold solder, etc.), and adhesives (epoxy adhesives, etc.).

[0040] In this embodiment, the front end joint 61 also enters the inner side of the first outer coil 50, and joins the folded-back portion 40A of the wire 40 with the base portion 40B. The front end joint 61 extends from the front end 51 of the first outer coil 50 toward the front end side, and in this extended portion, the folded-back portion 40A of the wire 40 is also joined with the base portion 40B.

[0041] The main body 10 of the guide wire 100 is composed of the coils 50, 55, and 90 as a whole and a portion of the wire 40. In this embodiment, the portion of the wire 40 that is inserted into the hollow portion of the first outer coil 50, including the coarse diameter portion 41, the first tapered portion 42, the intermediate diameter portion 43, the second tapered portion 44, the first fine diameter portion 47, and the second fine diameter portion 48, constitutes the main body 10.

[0042] The guide wire 100 has a leading portion 20 formed by a part of the wire 40. In this embodiment, the leading portion 20 is formed by the portion of the first narrow diameter portion 47 protruding from the front end 51 of the first outer coil 50 toward the front end side and the portion of the second narrow diameter portion 48 protruding from the front end 51 of the first outer coil 50 toward the front end side.

[0043] like Figure 1 As shown, when viewed along the X-axis, the outer diameter of the leading portion 20 varies along the central axis Ax. Specifically, the outer diameter of the leading portion 20 is approximately the same as the maximum outer diameter of the front end 16 of the main body 10 at the base 27 of the leading portion 20. The outer diameter of the leading portion 20 gradually decreases from the base 27 towards the front end, then gradually increases to reach its maximum outer diameter, and gradually decreases from the position of the maximum outer diameter to the front end 23 of the leading portion 20. The maximum outer diameter of the leading portion 20 is, for example, 0.2 mm or more and 1.0 mm or less. The maximum outer diameter of the leading portion 20 can be 0.3 mm or more and 0.8 mm or less, or 0.4 mm or more and 0.6 mm or less.

[0044] In this specification, the thickness of the leading portion 20 refers to the outer diameter of the leading portion 20 in a direction orthogonal to the direction of its maximum outer diameter. That is, the thickness of the leading portion 20 refers to the external dimension of the leading portion 20 in a direction orthogonal to both its maximum outer diameter and the central axis Ax. Figure 2 and Figure 3 As shown, in this embodiment, the thickness of the leading portion 20 is its outer diameter along the X-axis. The thickness of the leading portion 20 varies along the central axis Ax. Specifically, the thickness of the leading portion 20 is approximately the same as the maximum outer diameter of the front end 16 of the main body 10 at the base end 27 of the leading portion 20. The thickness of the leading portion 20 gradually decreases from the base end 27 towards the front end, and then remains approximately constant until the front end 23 of the leading portion 20.

[0045] The maximum outer diameter of the leading portion 20 is greater than its thickness. That is, the leading portion 20 is generally flat. The thickness of the leading portion 20 at the location of its maximum outer diameter is smaller than the maximum outer diameter of the front end 16 of the main body 10. The thickness of the leading portion 20 at the location of its maximum outer diameter is, for example, 0.02 mm or more and 0.3 mm or less. The thickness of the leading portion 20 at the location of its maximum outer diameter can be 0.04 mm or more and 0.2 mm or less, or 0.06 mm or more and 0.1 mm or less. The maximum outer diameter of the leading portion 20 is, for example, 1.2 times or more the thickness of the leading portion 20 at the location of its maximum outer diameter. The maximum outer diameter of the leading portion 20 can be 1.5 times or more the thickness of the leading portion 20 at the location of its maximum outer diameter, or 1.8 times or more.

[0046] The maximum outer diameter of the front end 16 of the main body 10 is smaller than the maximum outer diameter of the leading portion 20. The diameter of the hole in the lesion portion formed by the leading portion 20 is larger than the maximum outer diameter of the front end 16 of the main body 10. When the main body 10 passes through the hole formed in the lesion portion, a gap is created between the outer peripheral surface 17 of the main body 10 and the inner wall of the lesion portion. Small pieces of the lesion portion cut off by the leading portion 20 are discharged towards the base end side of the main body 10 through the gap between the outer peripheral surface 17 of the main body 10 and the inner wall of the lesion portion. The retention of small pieces of the lesion portion between the maximum outer diameter of the leading portion 20 and the front end 16 of the main body 10 is prevented. Thus, the main body 10 has a lesion discharge function that discharges small pieces of the lesion portion generated due to the contact between the rotating leading portion 20 and the lesion portion from the front end side of the main body 10 towards the base end side.

[0047] like Figure 1As shown, the guidewire 100 includes a first coating 31 and a second coating 32. The first coating 31 covers at least a portion of the leading portion 20. The first coating 31 may also cover a portion of the main body portion 10. In this embodiment, the first coating 31 covers region R31, which is formed by the entire leading portion 20 and the front end portion of the main body portion 10. The second coating 32 covers at least a portion of the main body portion 10. In this embodiment, the second coating 32 covers the middle portion of the main body portion 10, excluding the front end portion and the base end portion, i.e., region R32. Region R32 is located on the base end side of region R31. The sliding properties of the first coating 31 and the second coating 32 are different. For example, the sliding properties of the first coating 31 are lower than those of the second coating 32. The first coating 31 is, for example, hydrophobic and formed of silicone. The second coating 32 is, for example, hydrophilic and formed of polyvinylpyrrolidone, polyacrylic acid, polyacrylamide, polyvinyl alcohol, maleic anhydride copolymer, hyaluronic acid, etc.

[0048] The guidewire 100 also includes a third coating 33. The third coating 33 covers at least a portion of the main body 10. In this embodiment, the third coating 33 covers region R33, which is the base end of the main body 10. Region R33 is located on the base end side of region R32. The third coating 33 is formed, for example, from PTFE.

[0049] (Structure surrounding the ultrasonic sensor)

[0050] like Figure 2 and Figure 5 As shown, the main body 10 of the guidewire 100 includes an ultrasound sensor 70. The ultrasound sensor 70 transmits ultrasound waves based on transmitting electrical signals, receives ultrasound waves (echoes) reflected from inside and outside the blood vessel, and outputs an ultrasound probe (probe) that receives electrical signals. In other words, the guidewire 100 of this embodiment is an imaging guidewire that uses the ultrasound sensor 70 to visualize (image) the state of the blood vessel. The ultrasound sensor 70 is an example of an electrical component.

[0051] The ultrasonic sensor 70 can be composed of a single ultrasonic element, multiple ultrasonic elements arranged in a row, or multiple ultrasonic elements arranged in a two-dimensional configuration. In this embodiment, the ultrasonic transceiver surface of the ultrasonic sensor 70 is radially outward toward the main body 10 (in... Figure 5 In the example, it is configured in the positive Y-axis direction. That is, the guidewire 100 of this embodiment can realize side-view imaging.

[0052] Figure 6 and Figure 7 This is an explanatory diagram showing the structure surrounding the ultrasonic sensor 70 in the guide wire 100. Figure 6 express Figure 5 The XY cross section of the guide wire at position VI-VI is 100. Figure 7 This represents a portion of the YZ longitudinal section of guide wire 100. For example... Figure 6 and Figure 7 As shown, the ultrasonic sensor 70 has a piezoelectric element 72 as an ultrasonic oscillation section and a first electrode 73 and a second electrode 74 arranged in a manner that sandwiches the piezoelectric element 72. The ultrasonic sensor 70 may also have other layers such as an acoustic matching layer.

[0053] The piezoelectric element 72 is made of ceramics such as PZT (lead zirconate titanate) or polymers such as PVDF (polyvinylidene fluoride). As an ultrasonic oscillator, a MEMS device such as a CMUT (Capacitive Micro-machined Ultrasound Transducer) can be used instead of the piezoelectric element 72.

[0054] The first electrode 73 and the second electrode 74 are made of conductive materials such as copper. When the ultrasonic sensor 70 is composed of multiple ultrasonic elements, the first electrode 73 is disposed separately from each of the multiple ultrasonic elements. When the ultrasonic sensor 70 is composed of multiple ultrasonic elements, one second electrode 74 is shared by multiple ultrasonic elements. The second electrode 74 is a ground electrode, and its potential is set to a predetermined reference potential.

[0055] like Figure 7 As shown, the ultrasonic sensor 70 is disposed between the first outer coil 50 and the second outer coil 55 along the central axis Ax of the main body 10. The ultrasonic sensor 70 is disposed radially outward from the inner coil 90, and a surface (e.g., the surface where the first electrode 73 is located, hereinafter referred to as the "exposed surface") is exposed on the outer peripheral side.

[0056] The guide wire 100 also includes a cover 63, a first tube 81, a lead wire 83, an adhesive layer 84, a second tube 85, a first electrode terminal 86, and a second electrode terminal 87.

[0057] like Figure 7 As shown, the cover portion 63 is disposed between the first outer coil 50 and the second outer coil 55 along the central axis Ax of the main body portion 10. Figure 6 As shown, the cover 63 is configured to cover a portion of the inner coil 90 from the outside. The cover 63 covers the surface of the ultrasonic sensor 70 other than the exposed surface. The cover 63 is formed, for example, of a non-conductive resin material. The cover 63 may also cover the exposed surface of the ultrasonic sensor 70. In this case, the cover 63 may also function as an acoustic matching layer.

[0058] The first tube 81 is disposed between the first electrode 73 of the ultrasonic sensor 70 and the wire 40. The first tube 81 is formed of an insulating material such as polyimide. The first tube 81 is an example of an insulating component.

[0059] The second electrode 74 of the ultrasonic sensor 70 is electrically connected to the inner coil 90 via a conductive joint 82 (e.g., solder). The inner coil 90 is electrically connected to the wire 40 via a front-end joint 91 (e.g., solder). Therefore, the second electrode 74 of the ultrasonic sensor 70 is electrically connected to the wire 40 via the conductive joint 82, the inner coil 90, and the front-end joint 91. The conductive joint 82, the inner coil 90, and the front-end joint 91 are examples of a connection portion. The conductive joint 82 is an example of a first conductive joint. The front-end joint 91 is an example of a second conductive joint.

[0060] Lead 83 is, for example, enameled wire. The leading end of lead 83 is electrically connected to the first electrode 73 of ultrasonic sensor 70 via a conductive joint (e.g., solder). Lead 83 is configured to extend from the location of ultrasonic sensor 70 along wire 40 toward the base end side. Figure 7 As shown, at the front end of the main body 10, the lead wire 83 is positioned between the conductor 40 and the second outer coil 55. Figure 5 As shown, at the base end of the main body 10, a lead wire 83 is disposed between the outer peripheral surface of the conductor 40 and the adhesive layer 84 that covers the conductor 40 from the outside. Figure 5 The diagram of lead 83 is omitted. Lead 83 is an example of a signal line.

[0061] like Figure 1 , Figure 2 as well as Figure 5 As shown, the first electrode terminal portion 86 and the second electrode terminal portion 87 are cylindrical electrodes surrounding the outer periphery of the base end of the wire 40. The second electrode terminal portion 87 is electrically connected to the wire 40. As described above, the wire 40 is electrically connected to the second electrode 74 of the ultrasonic sensor 70. Therefore, the second electrode terminal portion 87 is electrically connected to the second electrode 74 of the ultrasonic sensor 70.

[0062] Lead 83 ( Figure 7 The base end of the lead wire 83 is electrically connected to the first electrode terminal portion 86. As described above, the front end of the lead wire 83 is electrically connected to the first electrode 73 of the ultrasonic sensor 70. Therefore, the first electrode terminal portion 86 is electrically connected to the first electrode 73 of the ultrasonic sensor 70. A second tube 85, formed of an insulating material such as polyimide, is sandwiched between the lead wire 40 and the first electrode terminal portion 86 to prevent short circuit between the lead wire 40 and the first electrode terminal portion 86.

[0063] The potential of the second electrode terminal 87 is set to a predetermined reference potential. Consequently, the potential of the second electrode 74 of the ultrasound sensor 70, which is electrically connected to the second electrode terminal 87, also becomes a reference potential, and the second electrode 74 functions as a ground electrode. When ultrasound is transmitted from the ultrasound sensor 70, the potential of the first electrode terminal 86 is set to a potential corresponding to the transmitted signal. Consequently, the potential of the first electrode 73 of the ultrasound sensor 70, which is electrically connected to the first electrode terminal 86, also becomes a potential corresponding to the transmitted signal, and a voltage is applied to the piezoelectric element 72 to transmit ultrasound. When the ultrasound sensor 70 receives the reflected wave of ultrasound, the potential of the first electrode 73 of the ultrasound sensor 70 becomes a potential corresponding to the ultrasound received by the piezoelectric element 72, and the potential of the first electrode terminal 86, which is electrically connected to the first electrode 73, also becomes a potential corresponding to the received ultrasound. Based on the electrical signals acquired via the first electrode terminal 86 and the second electrode terminal 87, the state of the blood vessels can be visualized (imaged).

[0064] (Effects of this implementation method)

[0065] As described above, the guidewire 100 of this embodiment has a long, narrow main body 10 and a leading portion 20. The main body 10 has a conductive wire 40, an ultrasonic sensor 70 having a first electrode 73 and a second electrode 74, a lead wire 83 electrically connected to the first electrode 73, a conductive joint 82 serving as a connection for electrically connecting the second electrode 74 to the wire 40, an inner coil 90, and a front-end joint 91. The leading portion 20 is connected to the front end 16 of the main body 10 and enters the lesion.

[0066] Thus, the guidewire 100 of this embodiment has a leading portion 20 and an ultrasound sensor 70. Therefore, when the surgeon inserts the leading portion 20 into the lesion, the ultrasound sensor 70 can image the condition around the lesion. Therefore, for example, the surgeon can immediately identify unwanted areas such as the guidewire 100 entering a false lumen, thereby improving the efficiency and safety of the surgery.

[0067] In the guidewire 100 of this embodiment, the second electrode 74 of the ultrasound sensor 70 is electrically connected to the wire 40 via a connecting portion. Therefore, the wire 40 functions as a signal transmission unit. Thus, a signal line connected to one electrode of the ultrasound sensor is not required, simplifying the wiring structure of the guidewire 100. Furthermore, since the guidewire 100 is made thinner, its vascular selectivity is improved. In the guidewire 100 of this embodiment, thinning of the wire 40 to ensure space for the signal line arrangement is suppressed, and the reduction in the rotational compliance of the guidewire 100 due to thinning of the wire 40 is also suppressed.

[0068] In this embodiment, the second electrode 74 is a ground electrode. According to this embodiment, electrical fluctuations in either the wire 40 or the portion electrically connected to the wire 40 can be suppressed.

[0069] In this embodiment, the main body 10 has an inner coil 90 arranged between the wire 40 and the ultrasonic sensor 70. The connection portion electrically connecting the second electrode 74 of the ultrasonic sensor 70 to the wire 40 includes: a conductive connection portion 82 that joins the second electrode 74 to the inner coil 90; and a front end connection portion 91 that joins the inner coil 90 to the wire 40. According to this embodiment, the rigidity and rotational transmission properties of the guidewire 100 are made to desired characteristics, and the front end connection portion 91 functions as an electrical connection portion, thus further simplifying the wiring structure in the guidewire 100.

[0070] In this embodiment, the main body 10 has a first tube 81 located between the first electrode 73 of the ultrasonic sensor 70 and the wire 40. According to this embodiment, short circuits between the first electrode 73 of the ultrasonic sensor 70 and the wire 40 can be prevented.

[0071] In this embodiment, the maximum outer diameter of the guide portion 20 is larger than the outer diameter (i.e., the thickness) of the guide portion 20 in the direction orthogonal to the direction of the maximum outer diameter. According to this embodiment, the guide portion 20 is flat and efficiently excavates the lesion, thus further improving the passability of the guidewire 100 relative to the lesion.

[0072] In this embodiment, the guide portion 20 has a portion whose outer diameter gradually increases from the base side toward the front side. According to this embodiment, the portion of the guide portion 20 whose outer diameter gradually increases from the base side toward the front side efficiently excavates the lesion, thus further improving the passability of the guidewire 100 relative to the lesion.

[0073] In this embodiment, the leading portion 20 is annular. According to this embodiment, the annular leading portion 20 can efficiently excavate the lesion, thereby improving the passability of the guidewire 100 relative to the lesion.

[0074] In this embodiment, the leading portion 20 is formed by a wire 40 integral with the wire 40 constituting the main body portion 10. According to this embodiment, the structure of the guide wire 100 can be simplified, and the leading portion 20 can be prevented from detaching from the main body portion 10.

[0075] In this embodiment, the main body 10 has a lesion discharge function. According to this embodiment, small pieces of the lesion generated by the contact between the guide portion 20 and the lesion are smoothly discharged from the front end side of the main body 10 toward the base end side, and the small pieces are prevented from obstructing the digging of the guide portion 20, thereby improving the passability of the guidewire 100 relative to the lesion.

[0076] In this embodiment, the lesion drainage function is achieved by a spiral groove 18 formed on the outer peripheral surface 17 of the main body 10. According to this embodiment, small pieces of the lesion are smoothly discharged from the front end side of the main body 10 toward the base end side along the groove 18, thereby improving the passability of the guidewire 100 relative to the lesion.

[0077] In this embodiment, the lesion drainage function is achieved by the maximum outer diameter of the front end 16 of the main body 10 being smaller than the maximum outer diameter of the guide portion 20. According to this embodiment, the small piece of the lesion is smoothly discharged from the front end side of the main body 10 toward the base end side along the outer peripheral surface of the main body 10, thereby improving the passability of the guidewire 100 relative to the lesion.

[0078] (Modified example)

[0079] The technology disclosed in this specification is not limited to the above-described embodiments, and can be modified in various ways without departing from its spirit, for example, the following modifications are also possible.

[0080] The structure of the guide wire 100 in the above embodiment is just one example and can be modified in various ways. For example, in the above embodiment, the first electrode 73 of the ultrasonic sensor 70 can also be a ground electrode.

[0081] In the above embodiments, the second electrode 74 of the ultrasonic sensor 70 can also be electrically connected to the wire 40 via a lead wire.

[0082] In the above embodiments, the guide wire 100 may also not have at least one of the first outer coil 50, the second outer coil 55, and the inner coil 90. For example, when the guide wire 100 does not have the inner coil 90, the second electrode 74 of the ultrasonic sensor 70 is electrically connected to the wire 40 via the conductive joint 82.

[0083] In the above embodiments, the electrical connection between the first electrode 73 and the first electrode terminal 86 of the ultrasonic sensor 70 is not limited to the lead 83, but can also be achieved by other means such as FPC (Flexible Printed Circuits).

[0084] In the above embodiments, the shape of the leading portion 20 is not limited to annular, but may be other shapes. For example, the shape of the leading portion 20 may be a generally flat paddle shape without a through hole, or a spoon shape without a through hole and with a recess formed on the surface.

[0085] In the above embodiments, the leading part 20 may also be formed by a component that is separate from the component constituting the main body part 10.

[0086] The materials used for the components in the above embodiments are merely one example and can be adapted to various conditions. The treatment method using the guidewire 100 in the above embodiments is also just one example and can be adapted to various conditions.

[0087] In the above embodiments, a guidewire 100 for treating lesions within blood vessels has been used as an example. The technology disclosed in this specification can generally be applied in the same way to medical devices used for treating lesions in the lumen of a living organism.

[0088] In the above embodiments, the electrical components may also be other sensor components, light-emitting components, camera components, etc.

Claims

1. A medical device (100), characterized in that, have: The elongated main body (10) includes a conductive wire (40), an electrical component (70) having a first electrode (73) and a second electrode (74), a signal line (83) electrically connected to the first electrode (73), and a connecting portion electrically connecting the second electrode (74) to the wire (40); and The leading part (20) is connected to the front end of the main body part (10) and enters the lesion.

2. The medical device (100) according to claim 1, characterized in that, The second electrode (74) mentioned above is a ground electrode.

3. The medical device (100) according to claim 1 or 2, characterized in that, The connection portion includes a conductive joint (82) that connects the second electrode (74) to the wire (40).

4. The medical device (100) according to claim 1 or 2, characterized in that, The main body (10) also has a coil (90) arranged between the wire (40) and the electrical component (70). The connection portion includes a first conductive joint (82) that connects the second electrode (74) to the coil (90), and a second conductive joint (91) that connects the coil (90) to the wire (40).

5. The medical device (100) according to any one of claims 1 to 4, characterized in that, The main body (10) also has an insulating component (81) between the first electrode (73) and the wire (40).

6. The medical device (100) according to any one of claims 1 to 5, characterized in that, The aforementioned electrical component (70) is an ultrasonic sensor (70).

7. The medical device (100) according to any one of claims 1 to 6, characterized in that, The maximum outer diameter of the aforementioned leading portion (20) is greater than the outer diameter, i.e., the thickness, of the aforementioned leading portion (20) in a direction orthogonal to the direction of the aforementioned maximum outer diameter.

8. The medical device (100) according to any one of claims 1 to 7, characterized in that, The aforementioned leading portion (20) has a portion whose outer diameter gradually increases from the base end side toward the front end side.

9. The medical device (100) according to any one of claims 1 to 8, characterized in that, The aforementioned leading part (20) is annular.

10. The medical device (100) according to any one of claims 1 to 9, characterized in that, The aforementioned leading part (20) is formed by a conductor (40) integral with the conductor (40) constituting the aforementioned main body part (10).

11. The medical device (100) according to any one of claims 1 to 10, characterized in that, The main body (10) has the function of lesion discharge.

12. The medical device (100) according to claim 11, characterized in that, The aforementioned lesion discharge function will discharge small pieces of the aforementioned lesion generated by the contact between the aforementioned leading part (20) and the aforementioned lesion from the front end side of the aforementioned main body (10) toward the base end side.

13. The medical device (100) according to claim 11 or 12, characterized in that, The aforementioned lesion discharge function is achieved through a spiral groove (18) formed on the outer peripheral surface (17) of the main body (10).

14. The medical device (100) according to claim 11 or 12, characterized in that, The aforementioned lesion discharge function is achieved by the fact that the maximum outer diameter of the aforementioned front end of the aforementioned main body (10) is smaller than the maximum outer diameter of the aforementioned leading part (20).

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