Guidewire with conductive element

Abstract

Methods of incorporating multiple conductors on a guidewire by building multiple conductor traces of variable size and material composition on separate insulating layers are described. The methods described in the present invention facilitate the assembly of sensors to guidewire or catheter elements. This method is particularly useful in situations where it is desirable to vary the electrical or mechanical properties of the device in a particular section to enhance the performance and reliability of the device (e.g., selective wear resistance) or to facilitate assembly (e.g., ease of soldering or connecting) or in some cases to achieve a desired electrical characteristic (e.g., impedance). Incorporating the desired properties into the same device requires an innovative approach to form the signal lines in an otherwise compact space without compromising the primary mechanical properties of the device.

Description

[0001] Cross-reference to related applications

[0002] This application filed with the United States Patent and Trademark Office with respect to the priority history of priority number 63 / 122,430, filed on December 7, 2020. The entire contents of that application are incorporated herein by reference. Technical Field

[0003] This invention relates to guidewires with sensors, and to methods and apparatus for assembling guidewires with multiple sensors integrated within or along the body of the guidewire. Specifically, this invention relates to guidewires with pressure sensors integrated within or along the body of the guidewire, and to methods and apparatus for assembling guidewires. Background Technology

[0004] Guidewires can have multiple sensors or sensor assemblies directly integrated into them. Such sensor-equipped guidewires can be adapted to measure a variety of physiological parameters within a patient. For example, sensors typically have one or more cables running through the guidewire, which are used to electrically couple the sensor element to electronic components.

[0005] A guidewire typically comprises a hyaluronic acid tube surrounding a core wire and a coil section, the core wire extending through the length or portion of the guidewire. The guidewire core can be made of stainless steel or nitinol, while the coil section is made of wire or braid, which provides the guidewire with flexibility, maneuverability, and kink resistance. Nitinol wire used on its own or in conjunction with stainless steel braids can also help increase flexibility and allow the wire to spring back into its shape.

[0006] Furthermore, guidewires have a standard diameter of 0.014 inches, so accommodating certain types of sensors, or multiple sensors, may be limited by the relatively small space provided by the guidewire. Additionally, guidewires are typically used to insert and advance through vascular systems, which can present extremely tortuous paths. Therefore, as the guidewire is pushed, pulled, or twisted through channels with numerous curves and bends, the guidewire and any sensors or electrodes along it may experience relatively large stresses.

[0007] A guidewire incorporating one or more electrodes along its length can present additional challenges to its construction and use. For example, the presence of multiple electrodes along the guidewire may require additional conductive wires extending along its length. Due to the limited space and flexibility required by the guidewire, it is desirable to construct any sensors and / or electrodes positioned along its length accordingly.

[0008] Therefore, guidewires need to be designed to provide an efficient configuration that integrates one or more electrodes and / or sensors along their length. Summary of the Invention

[0009] This disclosure provides a guidewire comprising: a guidewire core; a first insulating layer disposed on the surface of the guidewire core; a plurality of first conductive traces arranged to be spaced apart from each other in the lateral direction of the guidewire core and disposed on the surface of the first insulating layer along the length direction of the guidewire core; and a plurality of connecting segments disposed on at least one of two end sides of the plurality of first conductive traces in the length direction and electrically connected to an electronic component, wherein the ends of the plurality of first conductive traces having the plurality of connecting segments are arranged parallel to the length direction of the guidewire core, and the plurality of connecting segments are arranged in a straight line parallel to the longitudinal axis of the guidewire core.

[0010] In addition, a second insulating layer is provided that covers a plurality of first conductive traces and a first insulating layer, wherein the plurality of connecting segments may each be configured to include an internal opening that opens in the second insulating layer to reach the corresponding first conductive trace.

[0011] At least one conductive trace end may be formed to extend in the circumferential direction of the wire core so as to be positioned ahead of the ends of other adjacent conductive traces in the longitudinal direction of the wire core via a gap.

[0012] A conductive strip made of conductive material is arranged to cover at least a portion of the internal opening of the connecting section, and a conductive connecting member is provided on the internal opening. The connecting section is electrically connected to the conductive strip via the conductive connecting member, and the conductive strip and the conductive connecting member can be made of different conductive materials.

[0013] Each of the multiple conductive strips has an external opening that extends through the conductive strip in the thickness direction and is arranged to overlap with the internal opening. A conductive connecting member for electrically connecting the conductive strip to the connecting section can be disposed inside the external opening.

[0014] The external and internal openings can be arranged to overlap each other while being offset from each other along the length of the guidewire core.

[0015] The area of ​​an internal opening can be larger than the area of ​​an external opening.

[0016] External openings can be formed as rectangular shapes in a plan view.

[0017] The external opening can be formed as a notch in a plan view, wherein at least one of the two ends of the conductive strip in the width direction is open.

[0018] The external opening can be formed in a plan view as an inverted cone shape, which gradually widens from the position open at one of the two ends in the width direction of the conductive strip toward the side located off the width direction of the conductive strip.

[0019] Multiple connecting segments can each be disposed on the proximal side of two ends in the length direction of each of the multiple first conductive traces.

[0020] Each external opening can be formed on both ends of the conductive strip in the width direction.

[0021] Conductive strips and conductive connecting components can be made of conductive materials.

[0022] The conductive connection component can be made of anisotropic conductive material, which forms a conductive path in the thickness direction of the conductive strip by applying pressure in the thickness direction of the conductive strip, and the anisotropic conductive material is more elastically deformable than solder.

[0023] The conductive strip may include a conductive connecting member and a C-shaped member. The conductive connecting member is made of anisotropic conductive material and is arranged to fill the inside of the outer opening and the inside of the inner opening, and is covered with a second insulating layer. The C-shaped member is made of conductive material and is disposed on the outside of the conductive connecting member.

[0024] A conductive strip made of conductive material is arranged to cover at least a portion of the internal opening of a connecting section, the connecting section being electrically connected to the conductive strip via a conductive connecting member disposed inside the internal opening, and the conductive strip and the conductive connecting member can be integrally formed.

[0025] A conductive wire is provided that is wound around the outer circumferential surface of the second insulating layer, and the two ends of the conductive wire can be fixed to the first conductive trace through an internal opening.

[0026] In the first conductive trace, one end of the conductive wire is fixed to an area having a metal layer of gold or a gold alloy and a barrier metal layer to prevent diffusion between the metal layer and the conductive trace, and the conductive wire may be made of gold, a gold alloy or aluminum.

[0027] Multiple connecting segments can be disposed on the distal ends of two ends along the length direction of multiple first conductive traces.

[0028] Furthermore, the guidewire includes: a plurality of second conductive traces disposed on the surface of a second insulating layer; a third insulating layer arranged to cover the plurality of second conductive traces and the second insulating layer; a plurality of second connecting segments arranged in a straight line parallel to the longitudinal axis of the guidewire core on at least one of two end sides of the plurality of second conductive traces along the length direction and electrically connected to electronic components, and the plurality of second connecting segments being configured to include a second internal opening that opens in the third insulating layer to reach the corresponding second conductive trace; and a second conductive strip formed in the circumferential direction of the guidewire core to cover at least one of the plurality of second connecting segments, wherein the second connecting segment covered by the second conductive strip is electrically connected to the second conductive strip via a conductive connecting member disposed on the second internal opening.

[0029] Multiple connecting segments are disposed on the distal ends of two ends along the length of multiple first conductive traces. A conductive strip made of conductive material is arranged to cover at least a portion of the internal opening. The connecting segments are electrically connected to the conductive strip via conductive connecting members disposed in the internal opening. The conductive strip can be electrically connected to a printed circuit board equipped with electronic components via conductive connecting members for a substrate.

[0030] The printed circuit board has a flexible substrate member located on the conductive strip side and a rigid substrate member located on the distal side of the flexible substrate member, and electronic components can be disposed on the rigid substrate member.

[0031] The rigid substrate member has a receiving section for accommodating and mounting electronic components, and the rigid substrate member can be disposed on the distal side of the guide wire core.

[0032] The plurality of first conductive traces may include at least one group consisting of a plurality of first conductive traces of equal length.

[0033] Multiple first conductive traces constituting a group can form a point-symmetrical pair.

[0034] At least one of the plurality of first conductive traces constituting a group may have a meandering section so as to have the same length as the other first conductive traces in the group.

[0035] According to one aspect of this disclosure, a guidewire is provided, comprising: a guidewire core; a first insulating layer disposed on a surface of the guidewire core; a plurality of first conductive traces arranged to be spaced apart from each other in a lateral direction of the guidewire core and disposed on a surface of the first insulating layer in a length direction of the guidewire core; a second insulating layer covering the plurality of first conductive traces and the first insulating layer; a plurality of connecting segments disposed on at least one of two end sides of the plurality of first conductive traces in a length direction and electrically connected to an electronic component, the plurality of connecting segments including an internal opening that opens in the second insulating layer to reach a corresponding first conductive trace; a conductive strip formed in a circumferential direction to cover the plurality of connecting segments and the second insulating layer; an external opening penetrating the plurality of conductive strips in a thickness direction and arranged to overlap with the internal opening; and a conductive connecting member disposed inside the external opening and inside the internal opening to electrically connect the conductive strip to the connecting segments.

[0036] The external and internal openings can be arranged to overlap each other while being offset from each other along the length of the guidewire core.

[0037] The area of ​​an internal opening can be larger than the area of ​​an external opening.

[0038] External openings can be formed as rectangular shapes in a plan view.

[0039] The external opening can be formed as a notch in a plan view, wherein the end side of the conductive strip is open.

[0040] The external opening can be formed in a plan view as an inverted cone shape, which gradually widens from one of the two ends of the conductive strip in the width direction toward the side located away from the width direction of the conductive strip.

[0041] Each external opening can be formed on both ends of the conductive strip in the width direction.

[0042] Conductive strips and conductive connecting components can be made of conductive materials.

[0043] The conductive connection component can be made of anisotropic conductive material, which forms a conductive path in the thickness direction of the conductive strip by applying pressure in the thickness direction of the conductive strip.

[0044] Furthermore, the guidewire includes: a plurality of second conductive traces disposed on the surface of a second insulating layer; a third insulating layer arranged to cover the plurality of second conductive traces and the second insulating layer; a plurality of second connecting segments arranged in a straight line parallel to the longitudinal axis of the guidewire core at at least one of the two end sides along the length direction of the plurality of second conductive traces and electrically connected to electronic components, and the plurality of second connecting segments being configured to include a second internal opening that opens on the third insulating layer to reach the corresponding second conductive trace; and a second conductive strip formed in the circumferential direction of the guidewire core to cover at least one of the plurality of second connecting segments, wherein the second connecting segment covered by the second conductive strip is electrically connected to the second conductive strip via a conductive connecting member disposed on the second internal opening.

[0045] The plurality of first conductive traces includes at least one group consisting of a plurality of first conductive traces of equal length.

[0046] Multiple first conductive traces constituting a group can form point-symmetric pairs.

[0047] At least one of the plurality of first conductive traces constituting a group may have a curved segment so as to have the same length as the other first conductive traces in the group.

[0048] In another aspect of the invention, a guidewire is provided, comprising: a guidewire core; a first insulating layer disposed on a surface of the guidewire core; a plurality of first conductive traces arranged to be spaced apart from each other in a lateral direction of the guidewire core and disposed on a surface of the first insulating layer in a longitudinal direction of the guidewire core; a second insulating layer covering the plurality of first conductive traces and the first insulating layer; a plurality of connecting segments disposed on at least one of two ends of the plurality of first conductive traces in a longitudinal direction and including an internal opening that opens in the second insulating layer to access the plurality of first conductive traces; and a conductive member formed to cover the first conductive traces and the second insulating layer via at least one of the plurality of connecting segments, wherein a conductive path is formed in the thickness direction by applying pressure in the thickness direction.

[0049] Furthermore, an electronic component is provided that is electrically connected to multiple connecting segments, and the electrical connection component, as the electronic component, has multiple pressing segments corresponding to multiple first conductive traces, and the electrical connection component can be electrically connected to multiple first conductive traces by pushing each pressing segment against a conductive member.

[0050] The conductive component is made of anisotropic conductive material, which is more elastically deformable than solder.

[0051] Conductive strips can be provided to cover the surface of conductive components.

[0052] This disclosure can also be applied to long medical equipment that includes guidewires configured as described above.

[0053] According to another aspect of this disclosure, a method for manufacturing a guidewire is provided, the method comprising: providing a guidewire core; forming a first insulating layer on a surface of the guidewire core; forming a plurality of first conductive traces arranged along the length direction of the guidewire core on the surface of the first insulating layer; forming a plurality of connecting segments arranged in a straight line parallel to the longitudinal axis of the guidewire core at at least one of two ends along the length direction of the plurality of first conductive traces; placing an electronic component on the distal side of the guidewire core; and electrically connecting the first conductive traces to the electronic component via an internal opening of the connecting segments.

[0054] According to another aspect of this disclosure, a method for manufacturing a guidewire is provided, the method comprising: providing a guidewire core; forming a first insulating layer on a surface of the guidewire core; forming a plurality of first conductive traces arranged along the length direction of the guidewire core on the surface of the first insulating layer; forming a second insulating layer covering the plurality of first conductive traces and the first insulating layer; forming a plurality of connecting segments on at least one of two end sides of the plurality of first conductive traces along the length direction, the plurality of connecting segments including an internal opening in the second insulating layer to reach each of the plurality of first conductive traces; providing a conductive strip having an external opening on the surface of the second insulating layer such that the external opening and the internal opening overlap each other; forming conductive connecting members on the inside of the external opening and the inside of the internal opening for electrically connecting the conductive strip to a connecting segment corresponding to the conductive strip; disposing an electronic component on a distal end side of the guidewire core; and electrically connecting the electronic component to the conductive strip.

[0055] According to another aspect of this disclosure, a method for manufacturing a guidewire is provided, the method comprising: providing a guidewire core; forming a first insulating layer on a surface of the guidewire core; forming a plurality of first conductive traces arranged along the length direction of the guidewire core on the surface of the first insulating layer; forming a second insulating layer covering the plurality of first conductive traces and the first insulating layer; forming a plurality of connecting segments on at least one of two end sides of the plurality of first conductive traces along the length direction, the plurality of connecting segments including internal openings in the second insulating layer to reach each of the plurality of first conductive traces; forming a conductive member arranged to cover the first conductive traces and the second insulating layer located inside the internal openings of the connecting segments, wherein a conductive path is formed in the thickness direction by applying pressure in the thickness direction in the conductive member; disposing an electronic component on a distal end side of the guidewire core; and electrically connecting the electronic component to the conductive member.

[0056] The guidewire can incorporate multiple different sensors within or along its body. A particular variant, either along the guidewire body or at its distal end, can incorporate a pressure sensor optionally having one or more electrodes. A guidewire with one or more electrodes directly integrated along its body can have a proximal coil attached to an electrode fitting with one or more electrodes and a distal coil attached to the distal end of the electrode fitting. The guidewire core can extend through the length of the guidewire fitting and can extend partially or completely through the electrode fitting.

[0057] A variation for assembling guidewire fittings may typically include providing a core wire with a gradually decreasing distal section, securing a sensor package having one or more conductive wires to the core wire by passing the core wire through a wire receiving channel defined by or along the sensor package, securing one or more conductive wires to the core wire, and subsequently encapsulating one or more conductive wires and the core wire.

[0058] One embodiment of the method for forming a guidewire fitting may generally include providing a guidewire core, disposing an insulating layer on the surface of the guidewire core, and printing one or more conductive traces directly onto the surface of the insulating layer.

[0059] Another embodiment of the method for forming a guide wire fitting may generally include providing a guide wire core, disposing an insulating layer on the surface of the guide wire core, and disposing atomized conductive ink on the surface of the insulating layer to form one or more conductive traces.

[0060] Another embodiment of the method for forming a guidewire fitting may generally include providing a guidewire core, disposing an insulating layer on the surface of the guidewire core, disposing a conductive layer on the surface of the insulating layer, and removing a portion of the conductive layer such that one or more conductive traces are formed on the insulating layer.

[0061] In one variation of the guidewire assembly, the pressure sensor package may generally include a sensor housing that is formed as a cylindrical shell that surrounds or supports the pressure sensor assembly fixed therein. The sensor housing may define a sensing window along a side surface that exposes the pressure sensor to a fluid environment. A sensor core may be fixed within the sensor housing and connected to a flexible circuit extending from the proximal end of the sensor housing for connection to a controller or processor via one or more conductors extending through the length of the guidewire. Conductive traces or lines along the flexible circuit may be directly attached to one or more corresponding conductive lines that extend proximally through the guidewire body for electrical connection to the controller or processor.

[0062] Another variation includes the following configuration: instead of being directly attached to one or more conductive lines, the flexible circuitry extends proximally from the sensor housing. The flexible circuitry can be electrically connected to one or more conductive ring elements, which in turn are electrically connected to one or more conductive lines. The ring elements can be coaxially aligned and adjacent to each other, and the number of elements used can depend on the required number of electrical connections. One or more conductive lines can be selectively electrically coupled to specific disks or traces on the flexible circuitry, such that each ring element is electrically connected to a single disk or trace. Then, if desired, each ring element can be electrically coupled along its inner diameter to a selective conductive line, allowing the remainder of the ring element to be used for electrical connection to another conductor or assembly.

[0063] The sensor housing may define a longitudinal channel extending through the entire housing to allow the guidewire core to pass through the channel. The housing may also define a distal opening into which the distal end of the guidewire may be positioned and secured to extend from the distal end of the housing, wherein the guidewire core extends longitudinally through the housing adjacent to the flexible circuitry, pressure sensor, and sensing window, or extends longitudinally through the housing below the flexible circuitry, pressure sensor, and sensing window. The sensor core is shown secured within the housing, adjacent to the flexible circuitry extending proximally from the housing.

[0064] In another variation, used for electrical coupling elements within or along a guidewire, the guidewire fitting may have conductive ink printed on a polymer substrate to form a sub-fitting for transmitting signals from one end of a guidewire or conduit to the other. The need for conductive traces and their associated handling and manipulation is eliminated by using conductive traces directly on the device substrate and then insulating the traces with a dielectric material.

[0065] A polymer layer (e.g., PET, PTFE, etc.) can be heat-shrink coated onto the guidewire core to provide an insulating substrate. The polymer layer can be coated or deposited over the entire guidewire core, or a portion of the distal end can remain uncoated for securing pressure sensor fittings. One or more conductive traces (e.g., nano-silver, nano-gold, nano-copper, etc.) can then be directly printed onto the polymer layer, such that the traces extend from one or more corresponding distal disks to one or more corresponding proximal disks.

[0066] Because these one or more conductive traces are printed directly onto the polymer layer, they can be configured in a variety of different patterns. Once one or more conductive traces are printed onto the polymer layer, the traces can be insulated. One variation for insulating the traces may involve masking the ends of the traces that need to remain exposed to form a disk for electrical connection, and subsequently depositing another layer of polymer on the conductive traces. For example, another heat-shrink tubing or layer can be used, or another layer of polymer (e.g., PTFE, parylene, etc.) can be deposited on the exposed conductive traces using, for example, physical vapor deposition, dip coating, etc.

[0067] In another variation, the conductive coating can be applied to the dielectric coating via batch metallization processes such as physical vapor deposition (PVD) or by electroplating, electroless plating, or printing a wider metal layer on top of the dielectric layer using conductive ink. Metal layers, for example, can provide EM shielding and thus eliminate or reduce noise and increase the system signal-to-noise ratio (SNR).

[0068] Another variation for insulating the traces may involve printing a dielectric polymer directly onto the conductive traces using polymer ink. In the case of printing directly onto the conductive traces using polymer ink, the printing process can be used to selectively print the polymer ink to create an insulating layer while exposing portions of the conductive trace to form conductive pads for electrical coupling to a component.

[0069] Regardless of the method used, the resulting guidewire core and polymer layer can be coupled to the pressure sensor fitting. One or more ring elements can be electrically coupled along a portion of their inner diameter to a corresponding disk exposed along the flexible circuit, and a second portion of one or more ring elements can be electrically coupled to a corresponding disk of conductive traces disposed on the polymer layer to electrically couple the pressure sensor fitting (or any other component). The distal coil tip can then be attached to the distal end of the sensor housing, and polymer can be reflowed or molded over the guidewire core along the central section, the distal coil or along the tip of the distal section, and along the remaining portion of the guidewire core along the proximal section, and the portion between the electrodes (if used).

[0070] Another variation of the assembly method involves a polymer layer formed separately prior to being placed on the guidewire core. Conductive traces can be printed directly onto the outer layer of the polymer and extend along the length of the polymer layer along their corresponding exposed pads. An insulating layer can also be printed directly onto the conductive traces. In the case of a pre-printed polymer layer, the guidewire core can be inserted into the polymer layer and bonded with any number of suitable adhesives (e.g., cyanoacrylate, etc.). The pressure sensor fitting can then be secured to the guidewire core, and the flexible circuitry can be directly electrically coupled to the exposed pads at the attachment point to complete the electrical connection. In yet another variation for printing conductive traces, a polymer tube can be placed on the guidewire core, and one or more conductive traces can be printed on the outer layer of the tube. Conductive ink can then be used to print circular rings on the polymer tube such that the rings coincide with the exposed areas of the conductive traces, allowing the flexible circuitry of the pressure sensor fitting or any other component to be electrically coupled to the conductive traces via connection to the circular rings. Because the circular rings are printed around the circumference of the tube, the exposed areas can be longitudinally offset from each other to allow the rings to be printed around the entire circumference of the tube. Furthermore, there is preferably sufficient longitudinal spacing between the exposed areas to allow the rings to be printed coaxially with each other without interference. In other variations, partial circumferential rings may be printed instead of full circumferential rings.

[0071] Another variation for forming conductive traces can have a first insulating polymer layer (e.g., PARYLENE (Specialty Coating Systems, Inc., Indianapolis, . IN), TEFLON (DuPont (EIDu Pont De Nemours), Wilmington, . Delaware), polyimide, etc.) disposed on the outer surface of the guide wire core. A second conductive polymer layer of a conductive material (gold, silver, copper, etc.) is then coated onto the first polymer layer using any number of processes (e.g., chemical deposition, physical vapor deposition, etc.). The thickness of the conductive layer depends on the application and is typically determined by considering electrical requirements (current carrying capacity) and the mechanical requirements of the device (e.g., stiffness). This second conductive layer can be divided into discrete conductive elements using, for example, laser micromachining, photochemical etching, etc.

[0072] Then, depending on the application, the entire fitting can be insulated using a dielectric insulating polymer in the form of a coating or heat-shrinkable material (e.g., Teflon, PET, etc.). Depending on the application, several discrete conductive elements can be formed. Furthermore, depending on the application, various connection terminal sizes and shapes can be formed at either end to facilitate connection to the thus formed discrete conductive elements. This construction technique facilitates the direct realization of several discrete conductive elements on the device, eliminating the need to remove material to accommodate individual conductive wires or to hollow out the device to accommodate conductive wires or elements. Therefore, the expected device performance is greatly enhanced and manufacturing costs are reduced. Attached Figure Description

[0073] Figure 1 This is a front view of a guidewire with a sensor.

[0074] Figure 2 This is a front view of the guide wire core attached to the sensor.

[0075] Figure 3 It is a longitudinal cross-sectional view showing the state of conductive traces and conductive charged connections.

[0076] Figure 4 From Figure 3 The cross-sectional view observed in the direction of arrow IV-IV.

[0077] Figure 5 From Figure 3 The cross-sectional view observed in the direction of arrow VV.

[0078] Figure 6 It is a diagram showing the arrangement of multiple electrical connection segments aligned along a straight line.

[0079] Figure 7 From and Figure 5 The cross-sectional view viewed from the same direction shows the variation of the conductive band.

[0080] Figure 8A This is a schematic diagram showing the relationship between multiple conductive traces and multiple electrical connection segments.

[0081] Figure 8B This is a schematic diagram illustrating another relationship between multiple conductive traces and multiple electrical connection segments.

[0082] Figure 8C This is a schematic diagram illustrating yet another relationship between multiple conductive traces and multiple electrical connection segments.

[0083] Figure 9 This is a schematic diagram illustrating yet another relationship between multiple conductive traces and multiple electrical connection segments.

[0084] Figure 10It is a plan view showing the state of multiple electrical connection segments and multiple conductive links.

[0085] Figure 11A This is an enlarged plan view of an electrical connection section.

[0086] Figure 11B This is an enlarged planar view of a conductive band.

[0087] Figure 11C It is a plan view showing the arrangement of the notched section of the conductive strip and the opening of the insulating layer partially overlapping each other.

[0088] Figure 11D It is a plan view showing the state in which the notched section is electrically connected to the opening via a conductive connecting member.

[0089] Figure 12 This is a diagram showing the relationship between the notched section of the conductive strip and the opening of the insulating layer.

[0090] Figure 13 This is a diagram showing another relationship between the notched section of the conductive strip and the opening of the insulating layer.

[0091] Figure 14 This is a diagram showing yet another relationship between the notched section of the conductive strip and the opening of the insulating layer.

[0092] Figure 15 This is a diagram illustrating an embodiment in which the opening of the conductive strip is wider than the opening of the insulating layer.

[0093] Figure 16 yes Figure 15 A longitudinal cross-sectional view of an embodiment.

[0094] Figure 17 From Figure 16 The plan view is viewed in the direction of the arrow in the image.

[0095] Figure 18 This is a longitudinal cross-sectional view showing an embodiment where the opening in the insulating layer is wider than the opening in the conductive strip.

[0096] Figure 19 From Figure 18 The plan view is viewed in the direction of the arrow in the image.

[0097] Figure 20 This is a cross-sectional view showing an embodiment of anisotropic conductive material used as a conductive connection member.

[0098] Figure 21 This is a longitudinal cross-sectional view showing the distal end of a guidewire with multiple conductive trace layers.

[0099] Figure 22 This is a longitudinal cross-sectional view showing the proximal end of a guidewire with multiple conductive trace layers.

[0100] Figure 23 This is a diagram illustrating an embodiment in which a printed circuit board equipped with a sensor is attached to a conductive strip made of conductive lines.

[0101] Figure 24 This is a diagram illustrating an embodiment of a structure in which the sensor is attached to the distal side of the guidewire core.

[0102] Figure 25 This is a diagram illustrating an embodiment in which a sensor is mounted on a printed circuit board having a flexible substrate component and a rigid substrate component.

[0103] Figure 26 This is a diagram illustrating an embodiment in which a receiving section for accommodating a sensor is disposed on a rigid substrate member.

[0104] Figure 27 This is a diagram illustrating an embodiment in which the conductive strips are arranged corresponding to each conductive trace layer.

[0105] Figure 28 This is a diagram illustrating an embodiment where each conductive strip is electrically connected to the conductive traces of each layer.

[0106] Figure 29 This is a diagram illustrating an embodiment of using a flexible substrate comprising flexible substrate members and rigid substrate members, where the conductive strips correspond to each conductive trace layer.

[0107] Figure 30 This is a diagram illustrating an embodiment of the arrangement relationship between conductive strips, conductive traces, and electrical connection segments.

[0108] Figure 31 This is a diagram illustrating another embodiment of the arrangement relationship between conductive strips, conductive traces, and electrical connection segments.

[0109] Figure 32 This is a diagram illustrating another embodiment of the arrangement relationship between conductive strips, conductive traces, and electrical connection segments.

[0110] Figure 33 This is a diagram illustrating an embodiment of arranging corresponding conductive traces of different lengths.

[0111] Figure 34 This is a diagram illustrating an embodiment of arranging pairs of conductive traces of the same length.

[0112] Figure 35 This is a diagram illustrating another embodiment of setting up pairs of conductive traces of the same length.

[0113] Figure 36 This is a diagram illustrating an embodiment in which an anisotropic conductive elastomer is used as an anisotropic conductive material to electrically connect a conductive strip to a conductive trace.

[0114] Figure 37 This is a diagram illustrating an embodiment in which an anisotropic conductive elastomer is used as an anisotropic conductive material in a component that functions as both a conductive strip and an electrical connection segment.

[0115] Figure 38 From Figure 37 The cross-sectional view observed in the direction of arrow XXXVIII-XXXVIII.

[0116] Figure 39 This is an illustration schematically showing a connector component used to electrically connect a guidewire to an external device.

[0117] Figure 40A This is a plan view of the guidewire core.

[0118] Figure 40B It is a plan view of a wire core having a first insulating layer formed on its surface.

[0119] Figure 40C It is a plan view of the wire core, in which the conductive layer is formed on the surface of the first insulating layer.

[0120] Figure 40D It is a plan view of the guide wire core, in which multiple conductive traces are formed by selectively etching the conductive layer.

[0121] Figure 41 This is a diagram illustrating an embodiment of a method for connecting a sensor disk to an electrical connection segment.

[0122] Figure 42 From Figure 41 The front view is viewed in the direction of the arrow in the image.

[0123] Figure 43 This is a diagram illustrating an embodiment in which a conductive strip is used to connect the sensor disk to the electrical connection section.

[0124] Figure 44 This is a diagram illustrating an embodiment in which a marker segment having an area larger than the other portions can be formed on at least one of the distal and proximal sides of a conductive trace.

[0125] Figure 45 It is an external view of a wire core with conductive traces formed on its surface.

[0126] Figure 46 This is an external view of a wire core with conductive traces formed on its surface, viewed from another direction.

[0127] Figure 47 It is a plan view of the guide wire core, in which a second insulating layer is formed to cover the first insulating layer and the conductive trace.

[0128] Figure 48 It is a plan view of a wire core with electrical connection sections aligned in a straight line. Detailed Implementation

[0129] In this disclosure, conductive traces are formed on the guidewire core, and multiple electrical connection segments are individually provided at both ends along the length of the conductive traces. The multiple electrical connection segments are arranged in a straight line along the longitudinal axis of the guidewire core. The arrangement of the multiple electrical connection segments in a straight line includes not only the case where the multiple electrical connection segments are precisely aligned in a straight line, but also the case where the multiple electrical connection segments are arranged along substantially the same straight line. The case where the multiple electrical connection segments are arranged along substantially the same straight line includes, for example, the case where the multiple electrical connection segments are arranged in one direction within a predetermined rectangular area.

[0130] In this disclosure, multiple conductive traces are electrically connected to at least one sensor disposed on a guidewire via multiple electrical connection segments. For example, the sensor measures parameters such as pressure, temperature, and flow rate in body tissue in which the guidewire is inserted. The sensor measures these or other parameters physically or chemically. The signal measured by the sensor is output via the conductive traces to a measuring device placed outside the guidewire.

[0131] In this disclosure, guidewires will be interpreted as embodiments of long medical devices. However, this disclosure can be applied not only to guidewires but also to catheters. For example, this disclosure can also be applied to balloon catheters, microcatheters, cardiac catheters, pulmonary artery catheters, angiography catheters, urethral catheters, gastrointestinal catheters, etc.

[0132] It is worth noting that this disclosure includes not only the embodiments described below, but also variations. A portion of the configuration described in one embodiment can be replaced by a configuration described in another embodiment. A configuration of one embodiment can include a configuration of another embodiment.

[0133] Figure 1 The overall guidewire 10 is shown, with sensor 52 attached to the conductive trace. Figure 2 This is a front view of the guide wire core 20 with the sensor 52 attached. The guide wire 10 includes, for example, the guide wire core 20 and a sensor fitting 50 disposed on the distal side of the guide wire core 20. In this disclosure, in some cases, the proximal side of the guide wire 10 is referred to as the proximal side or mating side, and the distal side of the guide wire 10 is referred to as the distal side. This is achieved by assembling the coil bodies 41 and 42 and the corresponding annular electrodes 31 to... Figure 2The wire core 20 is formed on the wire core 20 shown. Coil bodies 41 and 42 are secured to the small-diameter segment 202 of the wire core 20 using a fixing material. The distal tip 43 located at the distal end of the wire core 20 is formed into an almost hemispherical shape by a fixing member that secures the distal end of the small-diameter segment 202 of the wire core 20 to the distal end of the coil body 42. For example, brazing material or adhesive can be used as the fixing material.

[0134] The guidewire core 20 is made of, for example, nitinol or stainless steel. The guidewire core 20 includes a large-diameter section 201 on the mating side, a small-diameter section 202 on the distal side of the large-diameter section 201, and a tapered section 203 located between the large-diameter section 201 and the small-diameter section 202. A sensor attachment section 2021 is formed on the distal side of the small-diameter section 202, such as... Figure 2 As shown. The external connection section 204 is formed on the proximal side of the large-diameter section 201. A plurality of ring electrodes 31 are provided on the external connection section 204 as embodiments of the conductive strip 30. The conductive strip 30 will be described below. The ring electrodes 31 are components for electrically connecting the guide wire 10 to an external circuit (not shown in the figure).

[0135] A tapered section 203 is formed to gradually reduce its diameter, allowing for a smooth connection from the distal end of the large-diameter section 201 to the proximal end of the small-diameter section 202. Multiple coil bodies 41 and 42 are disposed on the outer side of the small-diameter section 202. The sensor accessory 50 is disposed between the coil body 41 on the proximal side and the coil body 42 on the distal side. The coil bodies 41 and 42 are made of, for example, stainless steel, platinum (Pt), platinum-iridium alloy (Pt / Ir), etc. As described below, the guide wire core 20 may have one coil body. Another embodiment for the arrangement of the sensor accessory 50 will be described below.

[0136] As described below, from the sensor attachment section 2021 to the external connection section 204, along the lateral direction on the outer side of the guidewire core 20 ( Figure 1 Multiple conductive traces 22 are formed spaced apart from each other in the SD direction (in the sensor). The multiple conductive traces 22 have [features / features] on both the sensor attachment section 2021 and the external connection section 204. Figure 3 The multiple electrical connection segments 24 described herein. The lateral direction of the guidewire core 20 refers, for example, the circumferential direction of the guidewire core 20, as shown in the attached diagram. Figure 1 As shown in the SD direction. The cross-section of the guidewire core 20 is not only circular, but also elliptical or polygonal. For clarity, the cross-sectional shape of the guidewire core 20 is not limited to a circular shape, and the transverse direction of the guidewire core 20 is referred to as the lateral direction.

[0137] "The length direction of the guidewire core 20" refers to, for example... Figure 1The direction of the central axis OI-OI of the guidewire core 20 shown is illustrated. The central axis of the guidewire 10 is substantially coincident with the central axis of the guidewire core 20. Therefore, the length direction of the guidewire core 20 is substantially the same as the length direction of the guidewire 10. The longitudinal cross-sectional view refers to the cross-sectional view taken along the length direction of the guidewire 10.

[0138] Figure 3 It is a longitudinal cross-sectional view showing the state of conductive traces and conductive charged connections. Figure 3 The structure can be applied to the distal or proximal side of the guidewire 10. Figure 3 The structure shown can be installed on both the distal and proximal sides of the guidewire 10.

[0139] A first insulating layer 21 is disposed on the surface of the wire core 20. On the surface of the first insulating layer 21, a plurality of conductive traces 22 are formed spaced apart from each other in the lateral direction of the wire core 20. The following... Figure 6 The gap 28 described herein is formed between adjacent conductive traces 22. To form the gap 28, for example, a conductive layer formed on the surface of the first insulating layer 21 is etched into a predetermined shape using a laser beam or the like. The gap 28 having a desired width can be sized by controlling the output of the laser beam and / or the scanning trajectory, etc. Typically, the gap 28 is filled with an insulating material. The gap 28 may also be referred to as an insulating space segment.

[0140] Multiple electrical connection segments 24 are disposed on the distal or proximal ends, and / or both distal and proximal ends, of each conductive trace 22. The electrical connection segments 24 on the distal side of each conductive trace 22 are electrically connected to the sensor 52 via a printed circuit board 60. The electrical connection segments 24 on the proximal side of each conductive trace 22 are electrically connected to an external device (not shown), such as a measuring instrument. Each electrical connection segment 24 comprises an internal opening 231 and a conductive connection member 25. The internal opening 231 is formed on a second insulating layer 23 to reach the conductive trace 22. The conductive connection member 25 electrically connects a conductive strip 30 arranged to cover at least a portion of the internal opening 231 to the conductive trace 22. The conductive connection member 25 is disposed within the internal opening 231. In the following embodiment, the conductive connection member 25 is disposed within the internal opening 231. Figure 10 The internal opening 231 and the external opening 301 described in the text.

[0141] As shown below Figure 26 As described in the text, when the second conductive trace 26 is disposed outside the conductive trace 22 and the second insulating layer 23 is sandwiched therebetween, a predetermined portion of the third insulating layer 27 covering the second conductive trace 26 is opened to form an electrical connection segment 24. In this case, a second internal opening 271 is formed at a predetermined position in the third insulating layer 27, as will be described later. Figure 21As described in [the text]. In the electrical connection segment 24M, the electrical connection segment 24M to be connected to the first conductive trace 22 is electrically connected to the first conductive trace 22 via conductive connection members 25 provided on both the first internal opening 231 and the second internal opening 271. The electrical connection segment can be described as an opening (i.e., a through hole) formed at a predetermined location on the insulating layer for the purpose of electrical connection.

[0142] The conductive strip 30 is formed of conductive material in a cylindrical, annular, or C-shaped form. Each of the conductive strips 30 may be formed in the same shape, or the width of at least one of the conductive strips 30 may differ from the width of the other conductive strips. The thickness of at least one of the conductive strips 30 may differ from the thickness of the other conductive strips 30.

[0143] Corresponding to the corresponding electrical connection segment 24, a conductive strip 30 is disposed on the surface of the second insulating layer 23. Each conductive strip 30 is arranged to cover at least a portion of the internal opening 231 of the corresponding electrical connection segment 24. Each conductive strip 30 is electrically connected to each corresponding electrical connection segment 24 via a conductive connection member 25.

[0144] Figure 3 An embodiment is shown in which a predetermined area of ​​the inner circumferential surface of the conductive strip 30 is electrically connected to the electrical connection segment 24 via the conductive connecting member 25. This means that the conductive strip 30 and the conductive connecting member 25 are connected in a plane. More precisely, the conductive strip 30 and the conductive connecting member 25 are connected in a curved surface.

[0145] The conductive strip 30 and the conductive connecting member 25 may be made of different conductive materials or the same conductive material. The conductive strip 30 and the conductive connecting member 25 may be separately formed as individual components or integrally formed. Examples of conductive materials include conductive metallic materials such as copper, silver, and gold, conductive polymers, etc. Examples of conductive polymers include, but are not limited to, polypyrrole, polythiophene, polyacetylene, and polyaniline.

[0146] The wire core 20 can be made of a conductive material. When the wire core 20 is made of a conductive material such as stainless steel, the wire core 20 itself can be used as a ground electrode. A highly conductive metal layer (not shown) can be formed on the surface of the wire core 20. The highly conductive metal layer is not limited to metals such as copper, gold, and silver. The highly conductive metal layer can be made of a conductive polymer. Forming a highly conductive metal layer 29 on the surface of the wire core 20 ensures a return path for using the wire core 20 as a ground plane (GND). The wire core 20 alone can also be used as a ground electrode.

[0147] If the wire core 20 is not used as an electrical ground, any one of the plurality of conductive traces 22 may be used as an electrical ground. Either the wire core 20 or the conductive traces 22 may also be used as an electrical ground.

[0148] Figure 4 From Figure 3 The cross-sectional view observed in the direction of arrow IV-IV. Figure 5 From Figure 3 The image shows a cross-sectional view viewed in the direction of arrow VV. As described above, a first insulating layer 21 is formed over the entire circumference of the surface of the guide wire core 20. On the surface of the first insulating layer 21, a plurality of conductive traces 22 are formed spaced apart from each other in the lateral direction of the guide wire core 20. A second insulating layer 23 is formed to cover the first insulating layer 21 and the plurality of conductive traces 22. The first insulating layer 21, the conductive traces 22, and the second insulating layer 23 are formed in a stacked manner. For the first insulating layer 21 and the second insulating layer 23, materials with properties required according to the guide wire 10 can be used. These required properties of the insulating layers 21 and 23 include, for example, electrical insulation, core adhesion, dielectric properties (low ε), heat resistance, sterilization resistance, scratch resistance, abrasion resistance, chemical resistance, good slidability, water and moisture resistance, corrosion resistance, and adhesion to hydrophilic coating agents (hyaluronic acid, siloxanes, etc.).

[0149] The properties of the first insulating layer 21 may differ from those of the second insulating layer 23. In one embodiment, the first insulating layer 21 may be made of a material with a lower dielectric constant than the second insulating layer 23. When the dielectric constant of the first insulating layer 21 decreases, the parasitic capacitance between the conductive trace 22 and the wire core 20 can be reduced. This means that when the wire core 20 and the conductive trace 22 are used together as a wire, the mutual capacitance between the conductive trace 22 and the wire core 20 tends to be significantly higher than the mutual capacitance between the conductive traces. Effectively, the first insulating layer 21 sandwiched between the conductive trace 22 and the wire core 20 is made of a dielectric material with a lower dielectric constant when suppressing this increase in mutual capacitance. In another embodiment, the first insulating layer 21 may be made of a material with higher adhesion to the surface of the wire core 20 than to the surface of the second insulating layer 23. In yet another embodiment, the second insulating layer 23 may be made of a material with higher moisture resistance than the first insulating layer 21.

[0150] Examples of materials that can be used for the first insulating layer 21 and / or the second insulating layer 23 include epoxy resin, glass epoxy resin, bismaleimide triazine resin, BCB, polyimide, polyamide, polyamide-imide, polyurethane, LCP (liquid crystal polymer), PE (polyethylene), PET (polyethylene terephthalate), PFA (perfluoroalkoxy fluororesin), PTFE (polytetrafluoroethylene), ETFE (a copolymer of tetrafluoroethylene (C2F4) and ethylene (C2H4)), PEEK (polyetheretherketone), poly(p-xylene) resin, solder resist, etc.

[0151] As an embodiment, the first insulating layer 21 may be made of polyimide, and the second insulating layer 23 may be made of polyimide (including a reinforced grade containing filler). As another embodiment, the first insulating layer 21 may be made of LCP, and the second insulating layer 23 may be made of polyimide. As yet another embodiment, the first insulating layer 21 may be made of LCP, and the second insulating layer 23 may be made of PEEK. As yet another embodiment, the first insulating layer 21 may be made of polyimide, and the second insulating layer 23 may be made of PTFE. As yet another embodiment, the first insulating layer 21 may be made of polyimide, and the second insulating layer 23 may be made of parylene.

[0152] The width and thickness of each conductive trace 22 can be set according to the intended use of the conductive trace 22. The width and thickness of each conductive strip 30 can be set according to the intended use of the conductive strip 30.

[0153] Figure 6 This is a top view of one end of the guidewire 10A along its length, showing the arrangement of the conductive traces 22, the electrical connection segments 24, and the conductive strips 30. Although Figure 6 The example is explained with reference to two conductive traces 22(1) and 22(2), but the number of conductive traces 22 is not limited to two. The guide wire 10A may also include three or more conductive traces 22. Figure 6 The arrangement shown can be applied to both ends of the guidewire 10A along its length (i.e., at least one of the distal or proximal ends). Figure 6 The text explains the structure on the distal side of guidewire 10A. This means that... Figure 6The right side corresponds to the distal side of guidewire 10A. In this document, the numbers (1) and (2) in parentheses are accompanied by symbols indicating these configurations, used to distinguish the multiple conductive traces 22, the multiple electrical connection segments 24, and the multiple conductive strips 30.

[0154] One end 221(1) of a conductive trace 22(1) is formed as a straight line (rectangular shape) extending toward the distal end of the guide wire core 20. Compared to the end 221(1) of the conductive trace 22(1), the end 221(2) of another conductive trace 22(2) extends toward the distal end of the guide wire core 20 and bends toward the conductive trace 22(1) at an angle of approximately 90 degrees. Thus, the distal end of the conductive trace 22(2) is formed as an almost L-shape.

[0155] The trace width TW11 of conductive trace 22(1) and the trace width TW12 (trace width TW12 in the length direction) of conductive trace 22(2) excluding the end 221(2) are set to be substantially the same (TW11 = TW12). The trace width TW2 of the end 221(2) of conductive trace 22(2) may be greater than the trace width TW12 in the length direction (TW2 > TW12). The end 221(2) with a length width TW2 greater than the trace width TW12 may be referred to as, for example, a marking segment. Alternatively, the end 221(2) may be referred to as a large area segment or a land section. The terms marking segment, large area segment, etc., apply to other ends 221.

[0156] The ends 221(1) and 221(2) of multiple conductive traces 22(1) and 22(2) are arranged parallel to the length direction of the wire core 20. An electrical connection segment 24(1) is provided at the end 221(1) of one conductive trace 22(1). An electrical connection segment 24(2) is provided at the end 221(2) of another conductive trace 22(2). A line O2 passing through the center of each of the multiple electrical connection segments 24(1) and 24(2) is substantially parallel to the longitudinal axis O1 of the wire core 20. Each of the electrical connection segments 24(1) and 24(2) does not need to be precisely arranged in the straight line O2, and can be arranged slightly offset from the circumferential direction (minor axis direction) of the wire core 20. In other words, it is only necessary to place each of the electrical connection segments 24(1) and 24(2) within a predetermined range considering manufacturing tolerances, etc. Alternatively, the center position (centroid position) of the electrical connection segment 24(1) provided on a conductive trace 22(1) only needs to be within the range where the width dimension W1 of the conductive trace 22(1) and the circumferential width dimension W2 of the end 221(2) of the other conductive trace 22(2) overlap with each other.

[0157] The dimension L1 from the distal end of end 221(1) of conductive trace 22(1) to the proximal end of end 221(2) of conductive trace 22(2) can be greater than the dimension L2 of the circumferential gap 28 between conductive trace 22(1) and conductive trace 22(2) in the SD direction. Dimensions L1 and L2 can be substantially equal, or dimension L1 can be shorter than dimension L2. An example in which three or more electrical connection segments 24 are arranged in the longitudinal axis O1 of the guide wire core 20 will be described below.

[0158] Each of the electrical connection segments 24(1) and 24(2) has a conductive strip 30(1) and 30(2), respectively. The electrical connection segment 24(1) is connected via a conductive connecting member 25 (not in...). Figure 6 (As shown in the diagram) the conductive trace 22 (1) is electrically connected to the conductive strip 30 (1). The electrical connection segment 24 (2) is connected via the conductive connection member 25 (also not shown in the diagram). Figure 6 (As shown in the figure) the conductive trace 22(2) is electrically connected to the conductive strip 30(2).

[0159] Figure 7 It shows Figure 5 A variation thereof. The conductive strip 30A of the guide wire 10AA can be formed to have a C-shaped cross-section, which has a gap 30A1 in the circumferential direction. For example, the conductive strip 30A can be attached to the guide wire core 20 by externally covering the second insulating layer 23 with the conductive strip 30A having a C-shaped cross-section and then forging them.

[0160] Some relationships between the multiple conductive traces 22, the multiple electrical connection segments 24, and the multiple conductive strips 30 will be referred to Figures 8A to 8C and Figure 9 Let me explain. Figures 8A to 8C and Figure 9 This is a diagram showing the circumferential surface of the guide wire unfolded in a plane to understand the arrangement of the conductive traces 22 and the electrical connection segments 24, etc. Figures 8A to 8C and Figure 9 In order to distinguish the corresponding conductive traces 22 and the corresponding electrical connection segments 24 from each other, numbers are appended in parentheses to the accompanying symbols. Figures 8A to 8C and Figure 9 The guidewire core 20 and insulating layers 21 and 23 are not shown, but the arrangement of the corresponding conductive traces 22, corresponding electrical connection segments 24, and corresponding conductive strips 30 is schematically shown. In the following figures, large letter characters accompanying the guidewire symbol are also added to the conductive traces 22, electrical connection segments 24, etc., to distinguish them from the configurations described in other embodiments.

[0161] Figure 8AThree conductive traces 22B(1) to 22B(3) are shown as embodiments of multiple conductive traces. The conductive trace 22B(2) located at the center of the figure is formed in a straight line shape and has no marking segments. In contrast, marking segments 221B(1) and 221B(3) extending in the straight line O2 at the end of the conductive trace 22B(2) are formed on the distal side of the conductive traces 22B(1) and 22B(3), which are spaced apart from each other in the circumferential direction of the guide wire core 20 so as to sandwich the conductive trace 22B(2). No marking segments are formed on the proximal side of the respective conductive traces 22B(1) to 22B(3).

[0162] In the upper conductive trace 22B(1) of the figure, an electrical connection segment 24B(1) is provided on the distal end 221B(1), and an electrical connection segment 24B(4) is provided on the proximal end. In the center conductive trace 22B(2) of the figure, an electrical connection segment 24B(2) is provided on the distal end, and an electrical connection segment 24B(5) is provided on the proximal end. In the lower conductive trace 22B(3) of the figure, an electrical connection segment 24B(3) is provided on the distal end 221B(3), and an electrical connection segment 24B(6) is provided on the proximal end.

[0163] Conductive strips 30B are disposed on each of the electrical connection segments 24B(1) to 24B(6). Thus, conductive traces 22B(1) to 22B(6) are electrically connected to the corresponding conductive strips 30B via the electrical connection segments 24B(1) to 24B(6). The distal ends of the conductive traces 22B(1) to 22B(6) are electrically connected to the sensor 52 via the conductive strips 30B. Figure 8A and Figure 9 (Not shown in the image). The proximal ends of conductive traces 22B(1) to 22B(6) are electrically connected to an external device (not shown) via conductive strip 30. This description can also be applied to... Figure 8B , Figure 8C and Figure 9 The embodiment shown.

[0164] exist Figure 8A In the guidewire 10B shown, multiple electrical connection segments 24B(1) to 24B(3) on the distal side are arranged in a straight line O3 parallel to the longitudinal axis O1 (not shown) of the guidewire core 20 (not shown). Multiple electrical connection segments 24B(4) to 24B(6) on the proximal side are arranged along the SD direction (also called the lateral direction SD), which is the circumferential direction of the guidewire core 20. Therefore, only the electrical connection segments 24B(1) to 24B(3) on the distal side of the multiple first conductive traces 22B(1) to 22B(3) can be arranged along the straight line O3.

[0165] Figure 8BThe guidewire 10C shown has three conductive traces 22C(1) to 22C(3) as embodiments of multiple conductive traces. The conductive trace 22C(2) located at the center of the figure is formed in a straight line shape and has no marking segments. Marking segments 221C(1) and 221C(3) extending in the straight line O4 where the ends of the conductive trace 22C(2) are located are formed on the proximal and distal sides of the conductive traces 22C(1) and 22C(3), which are spaced apart from each other in the circumferential direction of the guidewire core 20 so as to sandwich the conductive trace 22C(2) therebetween. This means that the marking segments 221C(1) and 221C(3) extending in the case of bending at a right angle toward the central conductive trace 22C(2) are formed on the proximal and distal sides of the conductive traces 22C(1) and 22C(3). When the conductive trace 22C(2) is set to be parallel to the longitudinal axis O1 of the guide wire core 20, the straight line O4 connecting the centers of the two longitudinal ends of the conductive trace 22C(2) is substantially parallel to the longitudinal axis O1 of the guide wire core 20.

[0166] In conductive trace 22C(1), an electrical connection segment 24C(1) is provided on the distal end 221C(1), and an electrical connection segment 24C(4) is provided on the proximal end. In conductive trace 22C(2), an electrical connection segment 24C(2) is provided on the distal end, and an electrical connection segment 24C(5) is provided on the proximal end. In conductive trace 22C(3), an electrical connection segment 24C(3) is provided on the distal end 221C(3), and an electrical connection segment 24C(6) is provided on the proximal end 221C(6).

[0167] exist Figure 8B In the guidewire 10C shown, multiple electrical connection segments 24C(1) to 24C(3) located on the distal side and multiple electrical connection segments 24C(4) to 24C(6) located on the proximal side are arranged in a straight line O4 that is substantially parallel to the longitudinal axis O1 of the guidewire core 20.

[0168] Figure 8CThe guidewire 10D shown also has three conductive traces 22D(1) to 22D(3) as embodiments of multiple conductive traces. The conductive trace 22D(2) is formed in a straight line shape and does not have a marking segment. Marking segments 221D(1) and 221D(3) extending in the straight line O5 where the ends of the conductive trace 22D(2) are located are formed on the distal side of the conductive traces 22D(1) and 22D(3), and the conductive traces 22D(1) and 22D(3) are spaced apart from each other in the circumferential direction of the guidewire core 20 so as to sandwich the conductive trace 22D(2). Marking segments 221D(4) and 221D(6) extending in the straight line O5 where the ends of the conductive trace 22D(2) are located are formed on the proximal side of the conductive traces 22D(1) and 22D(3). Line O5 is a line connecting the centers of the two longitudinal ends of conductive trace 22D(2) located at the circumference center of guidewire 10D. When conductive trace 22D(2) is set to be parallel to the longitudinal axis O1 of guidewire core 20, line O5 is substantially parallel to axis O1.

[0169] When Figure 8C The guidewire 10D shown is Figure 8B When compared with the guide wire 10C shown, conductive traces 22D(1) and 22D(3) differ in length dimension from conductive traces 22C(1) and 22C(3). Figure 8B In the embodiment, compared to the two ends 221C(1) and 221C(4) of the conductive trace 22C(1), the two ends 221C(3) and 221C(6) of the conductive trace 22C(3) are located further outward in the longitudinal direction of the guide wire core 20. This means that the length dimension of the conductive trace 22C(3) is greater than the length dimension of the conductive trace 22C(1). Conversely, in Figure 8C In the embodiment, the length dimensions of conductive trace 22D(1) and conductive trace 22D(3) are substantially equal.

[0170] exist Figure 8B In the embodiment, the distal end 221C(3) of the conductive trace 22C(3) is located on the farthest side in the length direction of the guidewire core, and the proximal end 221C(6) of the conductive trace 22C(3) is located on the proximal side in the length direction of the guidewire core. The conductive trace 22C(2) is formed to have the shortest length dimension. The distal end 221C(1) of the conductive trace 22C(1) is located between the distal end 221C(3) of the conductive trace 22C(3) and the distal end of the conductive trace 22C(2). The proximal end 221C(4) of the conductive trace 22C(1) is located between the proximal end 221C(6) of the conductive trace 22C(3) and the proximal end of the conductive trace 22C(2).

[0171] Conversely, in Figure 8CIn this embodiment, on the distal side of the guidewire core 20, the distal end 221D(3) of the conductive trace 22D(3) is located on the farthest side of the guidewire core 20 in the length direction. The distal end 221D(1) of the conductive trace 22D(1) is located on the proximal side relative to the distal end 221D(3). The distal side of the conductive trace 22D(2) is located on the proximal side relative to the distal end 221D(1). On the proximal side of the guidewire core, the proximal end 221D(6) of the conductive trace 22D(1) is located on the proximal side in the length direction of the guidewire core 20. The proximal end 221D(4) of the conductive trace 22D(3) is located on the distal side relative to the proximal end 221D(6). The proximal end of the conductive trace 22D(2) is located on the distal side relative to the proximal end 221D(4).

[0172] like Figure 8C As shown, the lengths (wiring lengths) of conductive traces 22D(1) and 22D(3) are substantially equal, enabling the acquisition of wiring pairs for differential signals. An embodiment of equidistant wiring pairs will be further described below.

[0173] like Figure 9 As shown, the distal ends of conductive traces 22E(1) to 22E(3) can be bent at angles different from right angles. Figure 9 In the guidewire 10E, conductive traces 22E(1) and 22E(2) spaced apart from each other in the circumferential direction (SD direction) extend obliquely toward the straight line O6, such that the electrical connection segments 24E(1) to 24E(3) on the distal side of each of the conductive traces 22E(1) to 22E(3) are located in the straight line O6 which is substantially parallel to the longitudinal axis O1 of the guidewire core 20 (not shown).

[0174] The conductive trace 22E(3) is located in the straight line O6 and is formed in a linear (rectangular) shape. The electrical connection segment 24E(3) is provided on the distal side of the conductive trace 22E(3), and the electrical connection segment 24E(6) is provided on the proximal side of the conductive trace 22E(3).

[0175] Conductive trace 22E(2) is formed at a distance from conductive trace 22E(3) in the circumferential direction of the guide wire core 20. Compared to the distal end of conductive trace 22E(3), the distal end of conductive trace 22E(2) extends further toward the distal end of the guide wire core 20 and upwards to the position where it intersects with the straight line O6. Electrical connection segment 24E(2) is provided on the distal end of conductive trace 22E(2), and electrical connection segment 24E(5) is provided on the proximal end of conductive trace 22E(2).

[0176] Conductive trace 22E(1) is formed at a distance from conductive trace 22E(2) in the circumferential direction of the guide wire core 20. Compared to the distal end of conductive trace 22E(2), the distal end of conductive trace 22E(1) extends further toward the distal end of the guide wire core 20 and upwards to the position where it intersects with the straight line O6. Electrical connection segment 24E(1) is provided on the distal end of conductive trace 22E(1). Electrical connection segment 24E(4) is provided on the proximal end of conductive trace 22E(1).

[0177] Each of the electrical connection segments 24E(1) to 24E(6) has a conductive strip 30E. Each of the conductive traces 22E(1) to 22E(6) is electrically connected to the corresponding conductive strip 30E via a conductive connection member 25 (not shown) provided on the corresponding electrical connection segment 24E(1) to 24E(6).

[0178] Figure 10 It is a plan view showing the state of electrical connection between multiple electrical connection segments 24F and multiple conductive strips 30F. Figure 10 The proximal side of guidewire 10F (proximal side of guidewire core 20) is shown.

[0179] The conductive strip 30F is formed in a cylindrical, annular, or nearly C-shaped shape. In the following description, the width direction of the conductive strip refers to the direction along the longitudinal axis O1 of the guide wire core when the conductive strip is attached to the guide wire core. Therefore, the two ends in the width direction of the conductive strip 30F are the proximal end and the distal end of the guide wire core 20.

[0180] An external opening 301F is formed on the distal ends of both ends of the conductive strip 30F in the width direction (length direction of the guide wire). The external opening 301F is formed such that the distal ends of both ends of the conductive strip 30F in the width direction are etched into a rectangular shape. The external opening 301F is formed into a rectangular shape, in which the distal end side is open. The external opening 301F can also be referred to as a notch segment 301F.

[0181] The outer opening 301F of the conductive strip 30F is attached to the wire core 20 so as to partially overlap with the first inner opening 231F that opens on the second insulating layer 23 (not shown). A conductive connection member 25F (such as solder) fills the inner opening 231F from the outer opening 301F, such that the conductive strip 30F and the conductive trace 22 (in...) Figure 10 Electrical and mechanical connections (not shown). This means that the conductive strip 30F is bonded or fixed to the conductive trace 22 and electrically connected to the conductive trace 22 through conductive connecting members 25F disposed in the external opening 301F and the first internal opening 23IF.

[0182] Figure 10The state in which the conductive strip 30F is attached to the guide wire core 20 will be referred to Figures 11A to 11D To explain.

[0183] Figure 11A This is a plan view of the guide wire core 20. A rectangular first internal opening 231F is formed at a predetermined position in the second insulating layer 23. Since the first internal opening 231F is formed in a rectangular cylindrical shape to reach the surface of the first conductive trace 22, a portion of the conductive trace 22 is exposed within the first internal opening 231F.

[0184] Figure 11B This is a plan view of a conductive strip 30F. As described above, the distal ends of the two ends of the conductive strip 30F in the width direction are etched into rectangular shapes to form external openings 301F.

[0185] Figure 11C It shows Figure 11B The conductive strip 30F shown is attached to Figure 11A The state of the guidewire core 20 is shown. A conductive strip 30F is attached to the outside of the guidewire core 20 such that the outer opening 301F overlaps with the proximal side of the first inner opening 231F. The outer opening 301F can be attached to the guidewire core 20 so as to overlap, for example, almost half the area of ​​the first inner opening 231F.

[0186] Figure 11D The diagram illustrates a state where the conductive strip 30F is electrically and mechanically connected to the conductive trace 22 by injecting a conductive connection member 25F (e.g., solder) into the inner sides of the outer opening 301F and the first inner opening 231F. When the conductive strip 30F is formed of a metallic material and the conductive connection member 25F is made of a metallic material (such as solder), a wider area can be used for the metal used to form the conductive strip 30F and the metal used to form the conductive connection member 25F to join. This allows for improved reliability of the electrical and mechanical connections between the conductive strip 30F and the conductive trace 22.

[0187] like Figure 12 As shown, the opening size L5 of the outer opening 301FF of the conductive strip 30FF can also be set to be slightly smaller than the opening size L6 of the first inner opening 231FF. Opening sizes L5 and L6 refer to the circumferential (SD direction) lengths of the openings 301FF and 231FF, respectively. The outer opening 301FF can be attached to the guide wire core 20 so as to overlap with almost half or more of the area of ​​the first inner opening 231FF.

[0188] exist Figure 13In the conductor wire 10G shown, an external opening 301G, open on one side in the direction of axis O1, is formed on both ends of the conductive strip 30G in the width direction. A first internal opening 231G is formed to be longer than the width dimension L7 of the conductive strip 30G. The conductive strip 30G is attached to the conductor core 20 so as to be located almost at the center of the first internal opening 231G. Conductive connection members 25 (not shown), such as solder, fill the first internal opening 231G from the interior of the external opening 301G on both sides of the conductive strip 30G in the width direction.

[0189] exist Figure 13 In the illustrated embodiment, with Figures 11A-11D or Figure 12 Compared to the embodiment shown, the contact area between the conductive strip 30G and the conductive connecting member 25 can be increased. Therefore, in Figure 13 In the guide wire 10G shown, when both the conductive strip 30G and the conductive connecting member 25 are made of conductive metal material, the reliability of the electrical and mechanical connection between the conductive strip 30G and the conductive trace 22 can be further improved.

[0190] exist Figure 14 In the guide wire 10H shown, external openings 301H, etched into an almost trapezoidal shape, are formed on both sides of the conductive strip 30H in the width direction. The first internal opening 231H is formed to be longer than the width dimension L8 of the conductive strip 30H.

[0191] In the plan view, the external opening 301H is formed in a trapezoidal shape, which gradually widens from the open position 3011 at one of the two ends in the width direction of the conductive strip 30H toward the side 3012 located away from the width direction of the conductive strip 30H. The external opening 301H can also be represented as being formed in an inverted conical shape. An inverted conical shape refers to a shape in which the opening width WH gradually increases from the open position 3011 toward the center in the width direction of the conductive strip 30H. Conversely, each external opening 301H is formed in a conical shape, wherein the opening width WH gradually decreases from the side 3012 located near the middle in the width direction of the conductive strip 30H toward the end (open position 3011) of the conductive strip 30H.

[0192] When external openings 301H are formed on both sides in the width direction of the conductive strip 30H, the reliability of the electrical and mechanical connections between the conductive strip 30H and the conductive trace 22 is improved, such as in Figure 13As described in the embodiments. Furthermore, the external opening 301H is formed in an inverted conical or nearly trapezoidal shape, and therefore has a side 3013 inclined relative to the longitudinal axis O1 of the guidewire core 20. Thus, in a plan view, the conductive strip 30H can not only have a side 3012 orthogonal to the axis O1, but also sides 3013 and 3014 intersecting the axis O1 at angles different from 90 degrees. Thus, the conductive strip 30H is electrically and mechanically connected to the conductive trace 22 from multiple directions with different angles via the conductive connection member 25. Therefore, when the guidewire 10H is inserted into body tissue (such as a blood vessel) and moves through the body tissue, positional displacement of the conductive strip 30H can be prevented.

[0193] exist Figures 15 to 17 In the guide wire 10J shown, the area of ​​the outer opening 301J is larger than the area of ​​the first inner opening 231. The rectangular outer opening 30J is formed almost at the center of the conductive strip 30J. For example, the center of the outer opening 301J is almost located at the center of the conductive strip 30J in the width direction (axis O1 direction) and almost at the center of the conductive strip 30J in the circumferential direction (SD direction). However, the outer opening 301J may be located outside the center of the conductive strip 30J. Multiple outer openings 301J may be formed on the conductive strip 30J.

[0194] Figure 16 yes Figure 15 A longitudinal cross-sectional view of an embodiment. The width dimension (dimension in the direction of axis O1) of the outer opening 301J is longer than the width dimension of the first inner opening 231. A conductive connecting member 25J (such as solder) is disposed inside the outer opening 30J and the first inner opening 231J.

[0195] Figure 17 From Figure 16 The plan view is viewed in the direction of the arrow in the diagram. As described above, the area of ​​the outer opening 301J is larger than the area of ​​the first inner opening 231J. In other words, the outer opening 301J is formed in a rectangular shape that is larger than the first inner opening 231J. For example, the outer opening 301J is similar in shape to the first inner opening 231J. However, the scope of this disclosure also includes cases where the shape of the outer opening 301J differs from that of the first inner opening 231J. For example, the aspect ratio of the outer opening 301J may differ from that of the first inner opening 231J. Furthermore, the shape of the outer opening 301J may differ from that of the first inner opening 231J. For example, it is permissible for the outer opening 301J to be rectangular and the first inner opening 231J to be triangular, or for the outer opening 301J to be elliptical and the first inner opening 231J to be circular. The scope of this disclosure also includes combinations of shapes other than these combinations.

[0196] exist Figure 18 and Figure 19 In the guidewire 10K shown, the area of ​​the first internal opening 231K is larger than the area of ​​the external opening 301K. Therefore, compared with... Figure 16 Compared to the contact area in the embodiment, the contact area between the conductive connecting member 25K and the conductive trace 22 can be increased. Therefore, the reliability of the electrical and mechanical connections between the conductive strip 30K and the conductive trace 22 can be improved. The shapes of the external opening 301K and the first internal opening 231K can be similar to or different from each other.

[0197] Figure 19 From Figure 18 The plan view is viewed in the direction of the arrow in the diagram. The center of the outer opening 301K coincides with the center of the first inner opening 231K. The outer opening 301K is similar in shape to the first inner opening 231K. However, the scope of this disclosure also includes configurations in which the center of the outer opening 301K is offset from the center of the first inner opening 231K.

[0198] The conductive strip 30K is electrically connected to the conductive trace 22 using solder, conductive paste, or the like. An adhesive is then applied to the outer circumference of the conductive strip 30K or the adhesive is filled into the external opening 301K, allowing the conductive strip 30K to also be mechanically connected to the wire core 20. Similarly, in other embodiments described above, the conductive strip can be electrically connected to the conductive trace 22 of the wire 20 via a conductive material, and the conductive strip can be mechanically connected to the wire 20 via a non-conductive material. Alternatively, as described above, the conductive strip can be electrically and mechanically connected to the wire core 20 using a material with conductive and adhesive properties (such as solder).

[0199] Figure 20 This is a cross-sectional view of the guide wire 10L, showing an embodiment using an anisotropic conductive material as the conductive connection member. An anisotropic conductive layer 251 made of anisotropic conductive material is disposed between the second insulating layer 23 and the conductive strip 30L. The electrical connection segment 24L is composed of the first internal opening 231 that has entered the first internal opening 231 and the anisotropic conductive material layer 251.

[0200] An anisotropic conductive material is applied or bonded to the surface of the second insulating layer and the interior of the first internal opening 231, and the exterior of the anisotropic conductive material is covered with a conductive strip 30L, which is bonded by pressure bonding or thermocompression bonding, such that the conductive strip 30L can be electrically connected to the conductive trace 22 and mechanically attached to the guide wire core 20. Compared to the case where the conductive strip 30L is electrically connected to the conductive trace 22, this makes the electrical and mechanical connection between the conductive strip 30L and the guide wire core 20 more certain, and then the exterior of the conductive strip 30L is filled with adhesive for fixation.

[0201] Examples of anisotropic conductive materials include ACF (Anisotropic Conductive Film), ACP (Anisotropic Conductive Paste), and ACR (Anisotropic Conductive Rubber). ACF is an encapsulating resin formed by dispersing conductive particles in a thermosetting epoxy resin. ACP is a paste formed by dispersing conductive particles in a thermosetting epoxy resin.

[0202] When layer 251 is made of ACF or ACP, layer 251 is covered with conductive tape 30E and thermocompressed to form anisotropic conductive paths. These conductive paths are semi-permanent, allowing conductivity to be maintained even after the conductive tape 30E is removed. This enables reliable adhesion and increased strength between the conductive tape 30E and the polyimide constituting the insulating layer. In contrast, ACR only conducts electricity during pressurization, and conductivity disappears once pressurization ceases.

[0203] An anisotropic conductive layer 251 is disposed between the conductive strip 30L and the insulating layer 23 and conductive trace 22, allowing the conductive strip 30L to be electrically and mechanically connected to the insulating layer 23 and conductive trace 22, thereby creating a durable electrical and mechanical connection. For example, when the conductive strip 30L is connected to the conductive trace 22 using solder or conductive adhesive, cracks may be caused by externally applied mechanical stress. The electrical connection segment 24L is constructed of a flexible anisotropic conductive layer 251 to provide flexibility to the electrical connection segment 24L. Even if a crack is temporarily caused on the electrical connection segment 24L, the crack is naturally eliminated by the flexible anisotropic conductive layer 251. Therefore, even when external stress is applied, the electrical connection between the conductive strip 30L and the conductive trace 22 can be maintained, thereby improving the reliability of the lead 10L.

[0204] Figure 21 This is a longitudinal cross-sectional view of the distal side of the guide wire 10M, which has multiple conductive traces 22 and 26. Figure 22 This is a longitudinal cross-sectional view of the proximal side of the guide wire 10M, which has multiple conductive traces 22 and 26.

[0205] In the guidewire 10M, multiple conductive trace layers are formed on the guidewire core 20 in a stacked manner. The first conductive trace layer refers to the conductive layer in which the first conductive trace 22 is formed. The second conductive trace layer refers to the conductive layer in which the second conductive trace 26 is formed. Each of the conductive traces 22 and 26 can also be connected to different sensors (not shown) via different printed circuit boards (not shown).

[0206] The surface of the second conductive trace layer is covered by a third insulating layer 27. A second internal opening 271 is formed at a predetermined position in the third insulating layer 27. The electrical connection segment 24M(2) on the second conductive trace layer is composed of the second internal opening 271 and a conductive connection member 25. The electrical connection segment 24M(1) on the first conductive trace layer is composed of a first internal opening 231, a second internal opening 271, and a conductive connection member 25. Each of the electrical connection segments 24M(1) and 24M(2) is electrically and mechanically connected to each corresponding conductive strip 30 via the conductive connection member 25. For example, solder, conductive adhesive, ACF, ACP, etc. can be used as the conductive connection member 25.

[0207] Figure 23 The diagram shows the distal end of the guide wire 10N before the printed circuit board 60 equipped with sensor 52 is attached to the conductive strip 30N formed by conductive wires 32. The conductive wires 32 are fine-diameter wires or strips made of a conductive metallic material such as gold, silver, copper, or a gold alloy. The conductive wires 32 are wound around the guide wire core 20 from above the insulating layer 23 by a so-called wire bonding method and secured to the conductive trace 22 to form the conductive strip 30N. This means that the conductive wires 32 are wound around the guide wire core 20 from above the insulating layer 23 at the location of the first internal opening 231, and then the two ends of the conductive wires 32 are joined and secured to the conductive trace 22 within the first internal opening 231 to obtain the conductive strip 30N.

[0208] Conductive wire 32 is electrically and mechanically connected to the end 221 of conductive trace 22 (in Figure 23 (Not shown in the image). The marker end 221 can be formed as a multilayer metal film, for example, by plating gold or a nickel-gold alloy onto the surface of a copper-plated conductive trace. The conductive line 32 can be made of gold, a gold alloy, aluminum, etc. Since gold or a gold alloy is electrochemically stable, ion migration between adjacent conductive bands 30N can be suppressed by forming the conductive line 32 from gold or a gold alloy.

[0209] Sensor 52 is mounted on the distal side of printed circuit board 60. On the proximal side of printed circuit board 60, a plurality of pads 611 are configured to correspond to conductive strips 30N. Each pad 611 is electrically connected to a terminal (not shown) of sensor 52 via a wiring pattern (not shown). Each pad 611 is fixed to its corresponding conductive strip 30N using solder, conductive adhesive, etc., so that the conductive trace 22 is electrically connected to sensor 52.

[0210] Figure 24 The distal side of guidewire 10P is shown. Figure 24 In this configuration, sensor 52 is attached to the distal end of guide wire core 20 using conductive strip 30 and printed circuit board 60. Figure 24 This is a side view of the 10P guidewire.

[0211] Multiple conductive traces 22P are formed spaced apart from each other in the circumferential direction (SD direction or lateral direction) of the wire core 20. Each conductive trace 22P has an electrical connection segment 24P. Each conductive trace 22P is electrically connected to the conductive strip 30 via the electrical connection segment 24P. The positions of the corresponding electrical connection segments 24P are spaced apart from each other in the circumferential direction and in the axial direction O1 of the wire core 20. Each electrical connection segment 24P is electrically connected to each conductive strip 30. Therefore, the printed circuit board 60 can be electrically connected to the electrical connection segments 24P regardless of their positions. The disk of the printed circuit board 60 (in Figure 24 (Not shown) Electrically and mechanically connected to the conductive strip 30 via a conductive connecting member 612, such as solder.

[0212] Figure 25 The sensor portion of the guide wire 10Q is shown, but the configuration on the lead core side is not shown. The printed circuit board 60Q has a flexible substrate member 61 and a rigid substrate member 62, and the sensor 52 is mounted on the rigid substrate member 62. The printed circuit board 60Q for the guide wire 10Q includes a flexible substrate member 61 located on the proximal side and a rigid substrate member 62 disposed on the distal side of the flexible substrate member 61. With the corresponding conductive strip 30 (in... Figure 25 (Not shown in the image) Corresponding disk 611 is formed between the two surfaces of the guide wire core 20 facing the flexible substrate member 61. Figure 25 (Not shown in the image) The face of the guide wire core 20 refers to the surface of the guide wire core 20. Figure 25 The rigid substrate member 62 has a connecting segment 621 on the face facing the wire core 20, which is connected to other conductive strips (not shown) provided on a small diameter segment 202 (not shown) of the wire core 20 (not shown).

[0213] Figure 26 An embodiment is shown in which multiple sensors 52R1 and 52R2 are housed in a rigid substrate member 62R. The printed circuit board 60R used in the guide wire 10R includes a flexible substrate member 61 and a rigid substrate member 62R. The rigid substrate member 62R has multiple sensor housing sections 622R1 and 622R2. Sensors 52R1 and 52R2 are attached to the sensor housing sections 622R1 and 622R2, respectively. The rigid substrate member 62R with sensor housing sections 622R1 and 622R2 functions as a sensor housing. Figure 26An embodiment is shown in which multiple sensors 52R1 and 52R2 are housed within a rigid substrate member 62R; conversely, sensor 52R1 or sensor 52R2 may be housed within the rigid substrate member 62R. Three or more sensors may be housed within the rigid substrate member 62R. Sensors and electronic components other than sensors may be housed within the rigid substrate member 62R. Embodiments of electronic components other than sensors include signal processing circuitry, transmitting / receiving circuitry, etc. Each of the first conductive traces 22R is electrically connected to each corresponding conductive strip 30 via an electrical connection segment 24R.

[0214] Figure 27 An embodiment is shown in which conductive strips 30S1 and 30S2 are arranged to correspond to each layer of conductive traces 22S and 26S. Figure 27 The distal side of the guidewire 10S is shown. A plurality of first conductive traces 22S are formed extending to the distal side of the guidewire core 20. Each first conductive trace 22S is electrically connected to a first printed circuit board 60S1 via a conductive strip 30S1. A first sensor 52S is mounted on the first printed circuit board 60S1.

[0215] Compared to the distal end of the first conductive trace 22S, each of the second conductive traces 26S disposed outside the first conductive trace 22S is configured such that the distal end of the second conductive trace 26S extends to a position closer to the proximal end. Each second conductive trace 26S is electrically connected to the second printed circuit board 60S2 via a conductive strip 30S2. The second sensor 52S2 is mounted on the second printed circuit board 60S2. In this way, the printed circuit board can be connected to each conductive trace layer via the conductive strip.

[0216] Figure 28 An embodiment of the guide wire 10T is shown, in which a printed circuit board is connected to a plurality of conductive traces. The printed circuit board 60T1 is electrically connected to a first conductive trace 22T via a conductive strip 30T (1) and also electrically connected to a second conductive trace 26T via a conductive strip 30T (5). Although not shown, wiring patterns to be connected to the first conductive trace 22T and wiring patterns to be connected to the second conductive trace 26T are formed on the first printed circuit board 60T1.

[0217] The second printed circuit board 60T2 is electrically connected to the first conductive trace 22T via conductive strip 30T(2), and is also electrically connected to a plurality of second conductive traces 26T via conductive strips 30T(3) and 30T(4). Although not shown, wiring patterns to be connected to the first conductive trace 22T and wiring patterns to be connected to the second conductive traces 26T are formed on the second printed circuit board 60T2.

[0218] Figure 29An embodiment of a flexible substrate comprising flexible substrate members and rigid substrate members is shown, wherein the conductive strips correspond to each conductive trace layer. The printed circuit board 60T1 used in the guide wire 10T1 includes a flexible substrate member 61T and a rigid substrate member 62T. The flexible substrate member 61T is electrically connected to a plurality of second conductive traces 26T via conductive strips 30T1(3), 30T1(4), and 30T1(5). The rigid substrate member 62T is electrically connected to a plurality of first conductive traces 22T via conductive strips 30T1(1) and 30T1(2).

[0219] Multiple wiring patterns (not shown) are formed inside the rigid substrate member 62T, and a first conductive trace 22T is electrically connected to the sensor 52T via the wiring patterns. Multiple wiring patterns (not shown) are also formed inside the flexible substrate member 61T, and a second conductive trace 26T is electrically connected to the sensor 52T via the wiring patterns.

[0220] refer to Figures 30 to 32 This section will describe an embodiment of the arrangement of conductive traces, electrical connection segments, and conductive strips (or ring electrodes) on the proximal side of the guidewire. Figure 30 In the guidewire 10U shown, conductive traces 22U(1) and 22U(3) are arranged such that conductive trace 22U(2) located at the center of the guidewire core 20 (not shown) in the circumferential direction (SD direction) is sandwiched between the two sides in the circumferential direction. The ends 221U(1) of conductive trace 22U(1) and the ends 221U(3) of conductive trace 22U(3) are formed to bend at almost right angles toward the center in the circumferential direction of the guidewire core 20, such that the ends 221U(1) and 221U(3) are located closer to the proximal end of the guidewire core 20 than the proximal end of conductive trace 22U(2).

[0221] Each conductive strip 30 is attached to the surface of the second insulating layer 23 on the wire core to cover a portion of each corresponding electrical connection segment 24U. This means that a portion of the first internal opening 231U of each electrical connection segment 24U is exposed and not hidden by the conductive strip 30.

[0222] exist Figure 31 In the guidewire 10U1 shown, the corresponding electrical connection segments 24U1 are aligned in line O7. Line O7 is parallel to the longitudinal axis O1 of the guidewire 20. Both width-direction ends of the first internal opening segment 231U1 of each electrical connection segment 24U1 are exposed from the conductive strip 30. The width direction of the first internal opening segment 231U1 refers to the direction of axis O1.

[0223] The width of the first internal opening segment 231U1 is set to be longer than the width of the conductive strip 30. The conductive strip 30 is attached to a second insulating layer (not shown) covering the wire core 20, such that the center of the conductive strip 30 substantially coincides with the center of the first internal opening segment 231U1 in the width direction. Therefore, both ends of the first internal opening segment 231U1 protrude from the conductive strip 30. Conductive traces 22U1(1) to 22U1(4) are electrically connected to the conductive strip 30 via each corresponding electrical connection segment 24U1.

[0224] exist Figure 32 In the guidewire 10U2 shown, each electrical connection segment 24U2L and 24U2R is disposed on each of the two width-direction sides of each conductive strip 30. The electrical connection segment 24U2L on the proximal side is exposed from the proximal end of the two width-direction ends of the conductive strip 30. The electrical connection segment 24U2R on the distal side is exposed from the distal end of the two width-direction ends of the conductive strip 30. This means that each conductive strip 30 is attached to a second insulating layer (not shown) covering the guidewire core 20, such that the corresponding electrical connection segments 24U2L and 24U2R partially protrude. Conductive traces 22U2(1) to 22U2(4) are electrically connected to the conductive strip 30 via the corresponding electrical connection segments 24U2L and 24U2R.

[0225] Figure 33 An embodiment of the arrangement of conductive traces 22V is shown. In the conductor 10V, a plurality of first conductive traces 22V(1) to 22V(4) are formed spaced apart from each other in the circumferential direction (SD direction). The first conductive trace 22V(1) is the shortest, and the first conductive trace 22V(2) is longer than the first conductive trace 22V(1). The first conductive trace 22V(3) is longer than the first conductive trace 22V(2). The first conductive trace 22V(4) is the longest. As shown in the attached diagram. Figure 33 As shown, the first conductive traces 22V(1) to 22V(4) may be different in length from each other. The electrical connection segment 24V is provided on both ends of each of the first conductive traces 22V(1) to 22V(4).

[0226] Figure 34 Examples are shown of multiple first conductive traces 22V(1) to 22V(4) including at least one group of first conductive traces having the same length. Figure 34The diagram shows a wire 10V1 comprising a first group consisting of first conductive traces 22V1(1) and 22V1(4) and a second group consisting of first conductive traces 22V1(2) and 22V1(3). Each of the first and second groups consists of conductive traces having the same wiring length, which may also be referred to as an isometric wiring pair. Pairs consisting of conductive traces having the same wiring length can be used, for example, for wiring of differential signals.

[0227] The first conductive traces 22V1(1) and 22V1(4) constituting the first group are point-symmetric pairs. Furthermore, the first conductive traces 22V1(2) and 22V1(3) constituting the second group are also point-symmetric pairs. This means that when a first conductive trace belonging to a group rotates 180 degrees around its center of mass, the first conductive trace overlaps with other first traces belonging to the same group. Therefore, the lengths of the first conductive traces belonging to the same group are equal.

[0228] Electrical connection segment 24V1 is provided on both ends of each of the first conductive traces 22V1(1) to 22V1(4). Each of the first conductive traces 22V1(1) to 22V1(4) is electrically connected to the conductive strip 30 via the corresponding electrical connection segment 24V.

[0229] Figure 35 An embodiment is shown where at least one conductive trace belonging to the same group of first conductive traces has a bent segment 221V to have the same length as the other conductive traces. Figure 35 In the guide wire 10V2, a plurality of first conductive traces 22V2(1) to 22V2(4) have the same length and belong to the same group. Electrical connection segments 24V2 are provided on both ends of each of the conductive traces 22V2(1) to 22V2(4).

[0230] Compared to the two ends of the other first conductive traces 22V2(2) to 22V2(4), the two ends of the first conductive trace 22V2(1) are located at the innermost side in the direction of axis O1, and the two ends of the first conductive trace 22V2(2) are located outside the first conductive trace 22V2(1) in the direction of axis O1. The two ends of the first conductive trace 22V2(3) are located outside the first conductive trace 22V2(2) in the direction of axis O1. The two ends of the first conductive trace 22V2(4) are located outside the first conductive trace 22V2(3) in the direction of axis O1. Therefore, if Figure 35 The middle of each of the conductive traces 22V2(1) to 22V2(4) shown is a simple rectangle, then the arrangement of the conductive traces is similar to... Figure 33 The embodiments described herein are the same.

[0231] However, Figure 35 A portion of the plurality of first conductive traces shown includes a bend segment 221V2. This means that the first conductive traces 22V2(1) to 22V2(3) of the plurality of first conductive traces each have a bend segment 221(1) to 221V2(3) at approximately the middle portion of their length. The bend segment 221V2 may also be referred to as a bend wiring. The first conductive trace 22V2(4) does not have a bend segment 221V2 because both ends of the trace are located at the outermost point in the direction of axis O1. The other first conductive traces 22V2(1) to 22V2(3) whose two ends are located within the two ends of the first conductive trace 22V2(4) each include a bend segment 221V2(1) to 221V2(3) so as to have the same length as the first conductive trace 22V2(4) without a bend segment.

[0232] All first conductive traces 22V2(1) to 22V2(4) may have a curved segment 221V2, such that all first conductive traces 22V2(1) to 22V2(4) have the same length. Although Figure 35 The curved section 221V2 is shown as bending at a right angle, but the curved section 221V2 can also be formed to make a smooth turn.

[0233] exist Figure 36 In the guide wire 10W, the first conductive trace 22 and the conductive strip 30W are connected via an anisotropic conductive material layer 251. The anisotropic conductive material is, for example, ACR. Materials other than ACR can be used. For example, the anisotropic conductive material layer 251 is arranged to cover the entire surface of the end 221 (marking section) of the first conductive trace 22, which has a relatively large area.

[0234] An embodiment using an anisotropic conductive material layer 25IX instead of the electrical connection segment and conductive strip will be referred to the appendix. Figures 37 to 39 To illustrate. For example, ACR is used as an anisotropic conductive material. Figure 37 The proximal side of the guide wire 10X is shown. When using the guide wire 10X, the proximal side of the guide wire 10X is attached to the connector member 100. The connector member 100 is a component for electrically connecting an external device (not shown), such as a measuring device or controller, to the guide wire 10X. The connector member 100 includes a bottom section 104, a clamping section 101 rotatably attached to the bottom section 104, a plurality of pressing pins 102 protruding from the inner surface of the clamping section 101, and wiring 103 connected to each of the pressing pins 102. Each pressing pin 102 is arranged corresponding to a conductive trace 22.

[0235] The proximal end of the guide wire 10X is inserted into the connector member 100 to abut against the bottom section 104 of the connector member 100. Then, the clamping section 101 pinches the guide wire 10X, causing a pressing pin 102 provided on the inner surface of the clamping section 101 to press a predetermined position of the anisotropic conductive material layer 25IX. When the anisotropic conductive layer 25IX is pressed radially by the pressing pin 102, a conductive path is formed from the pressing pin 102 to the conductive trace 22. Thus, a sensor (not shown) on the distal end of the guide wire 10X is electrically connected to an external device via the conductive trace 22 and the connector member 100.

[0236] Figure 38 From Figure 37 The cross-sectional view shown is taken in the XXXVIII direction. An anisotropic conductive material layer 25IX is arranged to fill the interior of a first internal opening 231, which is formed on a second insulating layer 23 corresponding to the end 221 of the first conductive trace 22. Figure 38 Wiring 103 is not shown in the diagram.

[0237] Figure 39 This is a schematic perspective view of connector component 100.

[0238] Various methods are described to incorporate multiple conductors onto a guidewire by constructing multiple conductor traces of variable size and material composition on separate insulating layers. The methods described in this invention facilitate the assembly of sensors to guidewire or conduit elements. This approach is particularly useful in situations where it is necessary to modify the electrical or mechanical properties of a device in a specific section to enhance its performance and reliability (e.g., selective abrasion resistance), or to facilitate assembly (e.g., ease of soldering or connection), or in some cases to achieve desired electrical characteristics (e.g., impedance). Integrating desired performance into the same device requires an innovative method to form signal lines within an otherwise compact space without compromising the device's main mechanical properties.

[0239] Integrating conductive elements into the core of a typical 0.014” guidewire without compromising its required mechanical properties (such as tracking capability, torque response, etc.) can be challenging. Using layered manufacturing methods, such as those described in patent application 63 / 090,487 (incorporated herein), conductive elements can be formed directly on the core to maintain the basic mechanical properties of the guidewire device. However, integrating a larger number of conductive elements (e.g., more than four) into a core of a typical 0.014” or smaller guidewire diameter can be very challenging. Having more than four different signal-carrying elements on the same device can be advantageous when it is necessary to integrate more than one type of sensor or sensors requiring more than four discrete communication channels on the same device. This can be achieved using the layered method described below. It is worth noting that this disclosure applies not only to the 0.014” guidewire core 20 but also to other guidewires 10 with typical diameter dimensions.

[0240] Figure 40A A typical guidewire core 20 is shown. It comes in various diameters and tapers, with the diameter at the distal end of the device typically smaller than that of the rest of the device. The core material is typically stainless steel (SS) or nitinol or a combination thereof.

[0241] like Figure 40B As shown, an insulating layer 21 is formed on the metal core 20. The insulating layer 21 can be formed using various methods such as dip coating, spray coating, physical vapor deposition (PVD), chemical vapor deposition (CVD), printing, melt reflow, etc. The polymer can be polyimide, PET, nylon, polyetheramide (Pebax), etc.

[0242] Then, as Figure 40C As shown, a conductive layer is deposited on the insulating layer 21. One approach is to first apply a conductive layer (such as palladium or silver) as a seed, and then apply a layer of copper, gold, or other highly conductive metal using chemical plating or electroplating.

[0243] The conductive layer is then treated by selectively etching the conductor to form individual electrically isolated conductive elements 22. One way to achieve this is by using a laser to ablate the conductor to form individual traces.

[0244] Typically, the substrate on which conductive elements are bonded does not have a constant dimensional profile. For example, a typical coronary guidewire core is grounded, tapering distally to a smaller OD (outlet diameter), reducing device stiffness and making the distal end more trackable and non-invasive as it passes through blood vessels. Existing technology describes embedding conductive elements, such as flat strips, within a polymer insulating layer (US10791991 B1). This approach has limitations because it is difficult to change the conductor profile along the entire length of the device, which can vary from 180 cm to 300 cm.

[0245] Additionally, at the distal end of the conductor where it must be electrically connected to the sensor, conductive strips need to be formed or laminated on openings in the insulator to connect to the embedded conductor. (See below) Figures 41 to 43 This presents a challenge. The exposed sections are radially separated, making it impossible to connect them to a sensor disk that is typically in a single plane. Therefore, additional processes are required to form conductive strips so that the sensor can be connected to the traces. Figure 42 From Figure 41 The front view is viewed in the direction of the arrow in the image.

[0246] from Figure 41 and Figure 42 It is evident that because openings D1, D2, and D3 are radially separated, it is impossible to connect sensor disks S1, S2, and S3 to embedded conductors C1, C2, and C3 via exposed sections D1, D2, and D3. Forming conductive strips CB1, CB2, and CB3 on the exposed sections facilitates the connection of the sensor (…). Figure 43 ) connection.

[0247] One way to mitigate the above challenges is to apply a conductive layer over the insulating layer, such that the conductive layer conforms to the contour of the substrate as shown in Figure 40B. As described above and Figure 40D The individual conductive traces shown can be formed, for example, by laser ablation. In this method, the ablation pattern can be controlled to form "markers" at both the distal and proximal ends, such as... Figures 44 to 46 As shown.

[0248] Furthermore, in this method, the trace width can vary along the length of the device. Therefore, at the distal ends where the core wire length decreases significantly, the trace width can be correspondingly smaller. Thus, this method allows for a great deal of flexibility in the processing compared to other methods that embed the conductor in an insulating material. Additionally, the conductive material itself can vary along its length at specific locations to impart desired properties. For example, the conductive trace can be entirely copper along its length, and then gold flash can be added to both ends via electroplating to enhance the quality of the electrical connection.

[0249] Then a second insulating layer is applied over the currently electrically insulating conductive element, such as... Figure 47As shown. The insulating polymer can be polyimide, PET, nylon, Pebax, etc. This method allows for insulating layers different from the first base insulating layer to impart different desired properties. For example, the insulating layer can be impregnated with nano-sized silica to improve the abrasion resistance of the coating.

[0250] Then, openings in the second insulating layer 23 and the third insulating layer 27 are formed, for example, by etching and / or laser ablation, to form vias to access the corresponding conductive traces located directly beneath the insulating layers, such as... Figure 48 As shown. These through-holes form connection pads to connect or couple conductive elements thus formed to the outside of the guidewire, such as to one or more sensors on the distal end of the guidewire and connection terminals on the proximal end.

[0251] As can be seen, with Figure 41 Unlike other materials, all the through-holes or exposed surfaces on the external insulator for accessing the formed conductive elements are on a longitudinal axis, and therefore can be easily connected directly to the sensor disk or via flexible circuit elements.

Claims

1. A guidewire, the guidewire comprising: Guide wire core; A first insulating layer is disposed on the surface of the guide wire core; A plurality of first conductive traces are arranged to be spaced apart from each other in the lateral direction of the wire core and disposed on the surface of the first insulating layer along the length direction of the wire core, each of the plurality of first conductive traces having a distal end and a proximal end; as well as Multiple connecting segments are disposed on at least one of two ends along the length of the multiple first conductive traces and are electrically connected to electronic components. in: The ends of the plurality of first conductive traces having the plurality of connecting segments are arranged parallel to the length direction of the guide wire core. The plurality of connecting segments are arranged in a straight line parallel to the longitudinal axis of the guidewire core, and Between the nearest side of the distal end of the plurality of first conductive traces and the farthest side of the proximal end of the plurality of first conductive traces, the plurality of first conductive traces are arranged parallel to the longitudinal axis of the guidewire core. The guidewire further includes a second insulating layer covering the plurality of first conductive traces and the first insulating layer, wherein each of the plurality of connecting segments includes an internal opening that opens into the second insulating layer to reach the corresponding first conductive trace. A conductive strip made of conductive material is arranged to cover at least a portion of the internal opening of the connecting section. A conductive connecting member is disposed on the internal opening. The connecting section is electrically connected to the conductive strip via the conductive connecting member. The conductive strip and the conductive connecting member are made of different conductive materials. Each of the plurality of conductive strips has an external opening that extends through the conductive strip in the thickness direction and is arranged to overlap with the internal opening. The conductive connecting member for electrically connecting the conductive strip to the connecting segment is disposed inside the external opening.

2. The guidewire according to claim 1, wherein, At least one conductive trace has an end formed to extend in the circumferential direction of the guide wire core so as to be located ahead of the ends of other adjacent conductive traces in the longitudinal direction of the guide wire core via a gap.

3. The guidewire according to claim 1, wherein, The external opening and the internal opening are arranged to overlap each other while being offset from each other in the length direction of the guide wire core.

4. The guidewire according to claim 3, wherein, The area of ​​the internal opening is larger than the area of ​​the external opening.

5. The guidewire according to claim 4, wherein, The external opening is rectangular in plan view.

6. The guidewire according to claim 1, wherein, The external opening is formed as a notch in a plan view, wherein at least one of the ends of the conductive strip is open.

7. The guidewire according to claim 1, wherein, The external opening is formed in an inverted cone shape in a plan view, the inverted cone shape gradually widening from a position open at one of the two ends in the width direction of the conductive strip toward a side located off the width direction of the conductive strip.

8. The guidewire according to claim 1, wherein, The plurality of connecting segments are each disposed on the proximal side of two ends in the length direction of each of the plurality of first conductive traces.

9. The guidewire according to claim 5, wherein, Each external opening is formed on both end sides in the width direction of the conductive strip.

10. The guidewire according to claim 1, wherein, The conductive strip and the conductive connecting member are made of conductive material.

11. The guidewire according to claim 1, wherein, The conductive connection member is made of an anisotropic conductive material, which forms a conductive path in the thickness direction of the conductive strip by applying pressure thereon, and the anisotropic conductive material is more elastically deformable than solder.

12. The guidewire according to claim 1, wherein, The conductive strip includes: The conductive connection member, made of anisotropic conductive material and arranged to fill the inner side of the outer opening and the inner side of the inner opening, and covering the second insulating layer; and The C-shaped component is made of conductive material and is disposed on the outside of the conductive connection component.

13. The guidewire according to claim 1, wherein, The conductive strip and the conductive connecting member are integrally formed.

14. The guidewire according to claim 1, wherein, A conductive wire is provided that is wound around the outer circumferential surface of the second insulating layer, and the two ends of the conductive wire are fixed to the first conductive trace through the internal opening.

15. The guidewire according to claim 14, wherein, In the first conductive trace, one end of the conductive line is fixed to a region having a gold or gold alloy metal layer and a barrier metal layer, the barrier metal layer preventing diffusion between the metal layer and the conductive trace. and The conductive wire is made of gold, gold alloy or aluminum.

16. The guidewire according to claim 14, wherein, The plurality of connecting segments are disposed on the distal ends of the two ends along the length direction of the plurality of first conductive traces.

17. The guidewire according to claim 1, further comprising: A plurality of second conductive traces are disposed on the surface of the second insulating layer; A third insulating layer is arranged to cover the plurality of second conductive traces and the second insulating layer; A plurality of second connecting segments are arranged in a straight line parallel to the longitudinal axis of the guide wire core on at least one of two end sides along the length direction of the plurality of second conductive traces, and are electrically connected to the electronic component. Each of the plurality of second connecting segments includes a second internal opening that opens onto the third insulating layer to reach the corresponding second conductive trace. A second conductive strip is formed in the circumferential direction of the guide wire core to cover at least one of the plurality of second connecting segments, wherein The second connecting segment covered by the second conductive strip is electrically connected to the second conductive strip via a conductive connecting member disposed on the second internal opening.

18. The guidewire according to claim 1, wherein, The plurality of connecting segments are disposed on the distal ends of the two ends along the length direction of the plurality of first conductive traces. The conductive strip is electrically connected to the printed circuit board equipped with the electronic components via a conductive connection member for the substrate.

19. The guidewire according to claim 18, wherein, The printed circuit board has a flexible substrate member located on the conductive strip side and a rigid substrate member located on the distal side of the flexible substrate member; and The electronic components are mounted on the rigid substrate member.

20. The guidewire according to claim 19, wherein, The rigid substrate member has a receiving section for accommodating and mounting the electronic components, and the rigid substrate member is disposed on the distal side of the guide wire core.

21. The guidewire according to claim 1, wherein, The plurality of first conductive traces includes at least one group consisting of the plurality of first conductive traces of equal length.

22. The guidewire according to claim 21, wherein, The plurality of first conductive traces constituting the group are formed as point-symmetric pairs.

23. The guidewire according to claim 21, wherein, At least one of the plurality of first conductive traces constituting the group has a curved segment so as to have the same length as the other first conductive traces in the group.

24. A long medical device, the long medical device comprising the guidewire according to claim 1.

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