Physiological sensing intraluminal device and related methods

Abstract

An intraluminal sensing guidewire obtains physiological data within a body lumen of a patient. The guidewire includes a flexible elongate member configured to be positioned within the body lumen. The flexible elongate member includes a metallic core wire extending along a longitudinal axis. The guidewire further includes a sensing element at a distal portion of the flexible elongate member to obtain the physiological data, an electrical connector at a proximal portion of the flexible elongate member, and a wire bundle disposed between the sensing element and the electrical connector. The wire bundle includes a conductive wire in electrical communication with the sensing element and the electrical connector. The bundle further includes a reinforcing wire having a material strength greater than a material strength of the conductive wire.

Description

Technical Field

[0001] The subject matter described herein relates to apparatus and methods for improving the strength of fine-gauge multifilament conductor bundles in endovascular physiological sensing devices. This enhanced multifilament conductor bundle has specific, but not exclusive, utility for intravascular catheters and guidewires. Background Technology

[0002] The term "thread" is a noun referring to a thin wire, thread, or filament. Fine electrical wires can be called threads. Small-diameter medical devices such as intraluminal (e.g., intravascular) catheters and guidewires may contain sensors (e.g., pressure, temperature, flow, or imaging sensors), whose power and communication occur via bundles of multifilamentary conductors (e.g., bifilamentary, trifilamentary, etc.). The reduction in device size presents challenges related to the routing, winding, and securing of these multifilamentary conductor bundles during device manufacturing.

[0003] Current medical devices such as guidewires and catheters use a bundle of electrical wires, typically connected as two, three, or more conductive wires, to make electrical connections between electrical components, such as sensors or transducers and contacts. To make these connections, the wires can be wound or pulled along the length of the device from one end to the other. Because pure copper and many copper alloys have very low tensile and yield strengths, conventional wires have low mechanical strength. The manufacturing process for endoluminal catheters or guidewire devices may involve winding or stretching a multi-wire conductor bundle, which requires tensioning. Unfortunately, if this tension exceeds a threshold longitudinal force, it can cause plastic deformation of the conductive wires, which can lead to undesirable elongation and / or necking, for example, up to 100% elongation in some current processes. The associated narrowing of the conductors affects the mechanical and electrical properties of the wires, which can lead to manufacturing defects.

[0004] The information included in this background section of the specification, including any references recorded herein and any descriptions or discussions thereof, is included for technical reference purposes only and should not be considered as the subject matter to which the scope of this disclosure is to be limited. Summary of the Invention

[0005] What is disclosed is an in-lumen device comprising a reinforced multifilament conductor bundle with improved mechanical properties and characteristics. For example, during the manufacturing process of medical devices, the improved tensile strength can reduce elongation and necking of the fine-gauge filaments, thus reducing manufacturing defects. Including reinforcing filaments can reduce or eliminate plastic deformation of the multifilament conductor bundle while maintaining the required electrical properties.

[0006] In some currently used devices, a higher-strength alternative copper alloy (e.g., beryllium copper, abbreviated as BeCu) is sometimes used instead of pure copper in the wires of a multi-filament conductor bundle. However, these materials have only about 15-50% of the conductivity of pure copper, which may reduce the maximum current the wires can carry. Therefore, this disclosure addresses this problem by retaining pure copper, high-conductivity copper alloys, or other high-conductivity materials for most of the wires in the multi-filament conductor bundle, but adding reinforcing wires made of a high-strength material such as stainless steel (or replacing one of the low-strength conductive wires with it). The reinforcing wires may or may not have an insulating coating and may or may not be of a different specification than the other wires in the bundle. Any manufacturing or assembly process involving the tensioning of the multi-filament bundle can benefit from the reinforced multi-filament conductor bundle of this disclosure. Depending on the embodiment, the reinforcing wires may be used as conductors in a circuit or may extend alongside other electrical wires but not electrically connected.

[0007] The reinforced multifilament conductor bundles disclosed herein have specific, but not exclusive, utility for endoluminal medical catheters and guidewires. A general aspect of the reinforced multifilament conductor bundle includes an endoluminal sensing guidewire. The endoluminal sensing guidewire includes: a flexible elongated member configured for positioning within a patient's body lumen, wherein the flexible elongated member includes a metallic core wire extending along its longitudinal axis; a sensing element disposed at a distal portion of the flexible elongated member and configured to acquire physiological data when positioned within the body lumen; and an electrical connector disposed at a proximal portion of the flexible elongated member. The endoluminal sensing guidewire also includes a wire bundle disposed between the sensing element and the electrical connector, the wire bundle including: a first conductive wire having a first material strength, wherein the first conductive wire is in electrical communication with the sensing element and the electrical connector; and a first reinforcing wire having a second material strength greater than the first material strength.

[0008] Implementations may include one or more of the following features. In some embodiments, the first conductive wire and the first reinforcing wire extend side-by-side around the metal core wire in a helical manner. In some embodiments, the wire bundle further includes a second conductive wire that includes the first material strength, wherein the second conductive wire is in electrical communication with the sensing element and the electrical connector. In some embodiments, the wire bundle further includes a second reinforcing wire that includes the second material strength. In some embodiments, the first reinforcing wire includes an insulating coating. In some embodiments, the first conductive wire includes an insulating coating. In some embodiments, the wire bundle further includes an external coating that mechanically couples the first conductive wire to the first reinforcing wire along at least a portion of the length of the first conductive wire and the first reinforcing wire. In some embodiments, the first conductive wire includes copper. In some embodiments, the first reinforcing wire includes stainless steel. In some embodiments, the first reinforcing wire includes a cross-sectional diameter larger than the cross-sectional diameter of the conductive wire. In some embodiments, the length of the first reinforcing wire is less than the length of the first conductive wire. In some embodiments, the wire bundle includes a spiral portion and a non-spiral portion, wherein, in the non-spiral portion, at least the first conductive wire extends longitudinally along the length of the flexible elongated member toward at least one electrical contact, wherein the first conductive wire is electrically connected via the electrical contact to a conductive strip embedded in the flexible elongated member.

[0009] One general aspect includes a method for assembling an intraluminal sensing guidewire. The method includes: providing a flexible, elongated member configured for positioning within a patient's body lumen, wherein the flexible, elongated member includes a metal core wire extending along a longitudinal axis; attaching a sensing element to a distal portion of the flexible, elongated member, wherein the sensing element is configured to acquire physiological data when positioned within the body lumen; attaching an electrical connector to a proximal portion of the flexible, elongated member; assembling a wire bundle, wherein assembling the wire bundle includes coupling conductive wires to reinforcing wires, wherein the conductive wires have a first material strength, and wherein the reinforcing wires have a second material strength greater than the first material strength. The method further includes helically winding the wire bundle around the metal core wire. The method further includes coupling at least the conductive wires of the wire bundle to the sensing element and the electrical connector.

[0010] Implementations may include one or more of the following features. In some embodiments, the conductive wire comprises copper surrounded by an insulating coating. In some embodiments, the reinforcing wire comprises stainless steel. In some embodiments, the reinforcing wire comprises a cross-sectional diameter larger than the cross-sectional diameter of the conductive wire. In some embodiments, the reinforcing wire is shorter than the conductive wire. In some embodiments, assembling the wire bundle comprises attaching the conductive wire to the reinforcing wire. Attaching the conductive wire to the reinforcing wire comprises attaching the insulating coating of the conductive wire to the insulating coating of the conductive wire. In some embodiments, attaching the conductive wire to the reinforcing wire comprises forming an insulating layer around the conductive wire and the reinforcing wire. In some embodiments, winding the wire bundle around the metal core wire in the spiral manner comprises winding the wire bundle around a first portion of the metal core wire in the spiral manner, and wherein the method further comprises: coupling the wire bundle to the flexible elongated member such that the wire bundle extends linearly along different second portions of the metal core wire.

[0011] One general aspect includes an intravascular flow sensing guidewire. The intravascular flow sensing guidewire further includes: a flexible elongated member configured to be positioned within a blood vessel, wherein the flexible elongated member includes a metal core wire extending along a longitudinal axis; a flow sensor disposed at a distal portion of the flexible elongated member and configured to sense the velocity of blood flow within the blood vessel; and an electrical connector disposed at a proximal portion of the flexible elongated member. The intravascular flow sensing guidewire further includes: a wire bundle disposed between the flow sensor and the electrical connector, the wire bundle including: a first conductive wire comprising a first material having a first material strength; a second conductive wire comprising the first material, wherein the first and second conductive wires are in electrical communication with the flow sensor and the electrical connector; and a reinforcing wire comprising a different second material having a second material strength greater than the first material strength, wherein the first, second, and reinforcing wires extend side-by-side with each other in a helical manner around at least a portion of the length of the metal core wire.

[0012] This overview is provided as an option to introduce the concepts in a simplified form, as further described below in the detailed description. This overview is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A broader presentation of the features, details, utility, and advantages of the reinforced multifilament conductor bundles as defined in the claims is provided in the following written description of various embodiments of this disclosure and illustrated in the accompanying drawings. Attached Figure Description

[0013] Illustrative embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

[0014] Figure 1 This is a schematic side view of an intravascular sensing system including an intravascular device comprising a bundle of multifilament electrical conductors, according to aspects of this disclosure.

[0015] Figure 2 This is a perspective view of an example electronic component of an intravascular device according to aspects of this disclosure.

[0016] Figure 3 This is a perspective view of a multi-filament conductor bundle according to aspects of this disclosure.

[0017] Figure 4 This is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure.

[0018] Figure 5 This is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure.

[0019] Figure 6 This is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure.

[0020] Figure 7 This is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure.

[0021] Figure 8 This is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure.

[0022] Figure 9 This is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure.

[0023] Figure 10 This is a schematic side view of an intravascular device including a reinforced multifilament electrical conductor bundle according to at least one embodiment of the present disclosure.

[0024] Figure 11 This is a schematic side view of an intravascular device including a bundle of multifilament electrical conductors according to at least one embodiment of the present disclosure.

[0025] Figure 12 This is a schematic diagram of a processor circuit according to at least one embodiment of the present disclosure.

[0026] Figure 13 This is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. Detailed Implementation

[0027] The enhanced multifilament conductor bundle disclosed herein provides improved overall material strength for the wire assembly to reduce elongation and necking of fine-gauge wires during the manufacturing process for medical devices. For example, the fine-gauge wires may have a size of 40-54 American Wire Gauge (AWG) or a diameter of 0.0799-0.01575 mm. Improved tensile strength of the multifilament conductor bundle can reduce manufacturing defects in small electronic devices such as intravascular medical catheters and guidewire devices.

[0028] The introduction of reinforcing filaments can reduce or eliminate plastic deformation of multifilament conductor bundles while maintaining electrical properties and performance. This can be achieved by incorporating one or more higher-strength materials into one or more fine-gauge multifilament conductor bundles to optimize their handling and assembly into electromechanical devices. Often, these conductors are incorporated into medical devices solely for their electrical properties and high mechanical strength is not required. However, in exemplary cases of medical guidewires and catheters, there are manufacturing and assembly processes that could benefit from using conductor bundles (e.g., cables) with higher mechanical strength.

[0029] Aspects of this disclosure may include one or more features described in U.S. Patent Publications US 2014 / 0187874, 2015 / 0273187, 2015 / 0297138, 2016 / 0303354, 2016 / 0058977, and 2019 / 0059817, and U.S. Patent 9770225, each of which is incorporated herein by reference in its entirety as if fully set forth herein.

[0030] Therefore, this disclosure provides a multi-filament conductor bundle comprising pure copper or a highly conductive copper alloy for the majority of the filaments in the bundle, and (a) one or more non-conductive reinforcing filaments having high tensile strength and high yield strength without changing the number of conductive filaments, (b) conductive filaments made of a high-strength material (such as stainless steel), or (c) increasing the diameter of one of the filaments with or without alteration to its composition. Any of these methods will increase the overall strength of the multi-filament bundle while maintaining the desired electrical properties of at least the majority of the conductors. The reinforcing filaments may or may not have an insulating coating and may or may not have a diameter different from the other filaments in the bundle. For example, high-strength stainless steel may have a substantially low conductivity (e.g., 3-15% of the conductivity of pure copper). Including one or more filaments with lower conductivity and filaments with relatively higher conductivity may be suitable if not all filaments carry large currents or high-frequency signals (e.g., signal grounding).

[0031] The fabrication of multifilament conductor bundles can be performed by the supplier based on component or material specifications. Reinforced multifilament conductor bundles can advantageously improve the assembly workflow of endoluminal medical devices. Depending on the implementation, the reinforcing filaments can be used in circuits as signal-carrying conductors, grounding conductors, or as structural reinforcements extending to the termination point along with other electrical filaments, and then not used in electrical connections.

[0032] These descriptions are provided for illustrative purposes only and should not be construed as limiting the scope of reinforced multifilament conductor bundles. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0033] For the purpose of facilitating an understanding of the principles of this disclosure, reference will now be made to embodiments illustrated in the accompanying drawings, and these embodiments will be described using specific language. However, it should be understood that this is not intended to limit the scope of this disclosure. Any variations and other modifications to the described devices, systems, and methods, and any other applications of the principles of this disclosure, are fully contemplated and included within this disclosure, as would commonly conceive of by one skill in the art to which this disclosure pertains. Specifically, it should be fully appreciated that features, components, and / or steps described with respect to one embodiment can be combined with features, components, and / or steps described with respect to other embodiments of this disclosure. Furthermore, while the following description may relate to blood vessels, it will be understood that this disclosure is not limited to such applications. For example, the devices, systems, and methods described herein can be used in any body compartment or body lumen, including the esophagus, veins, arteries, intestines, ventricles, atria, or any other body lumen and / or compartment. However, for the sake of brevity, multiple iterations of these combinations will not be described separately.

[0034] Figure 1This is a schematic side view of an intravascular sensing system 100 including an intravascular device 102 comprising a multifilament conductor bundle 30, according to aspects of this disclosure. The intravascular device 102 may be an intravascular guidewire, sized and shaped for positioning within a patient's blood vessel. The intravascular device 102 may include a distal tip 108 and a sensing element 112. The sensing element 112 may be an electronic, electromechanical, mechanical, optical, and / or other suitable type of sensor. For example, the electronic element 112 may be a flow sensor configured to measure blood flow velocity within a patient's blood vessel, a pressure sensor configured to measure blood flow pressure within the blood vessel, or another type of sensor including, but not limited to, temperature or imaging sensors. For example, flow data obtained from the flow sensor may be used to calculate physiological variables such as coronary flow reserve (CFR). Pressure data obtained from the pressure sensor may be used, for example, to calculate physiological pressure ratios (e.g., FFR, iFR, Pd / Pa, or any other suitable pressure ratio). Imaging sensors may include intravascular ultrasound (IVUS), intracardiac echocardiography (ICE), optical coherence tomography (OCT), or intravascular photoacoustic (IVPA) imaging sensors. For example, an imaging sensor may include one or more ultrasound transducer elements, including an array of ultrasound transducer elements.

[0035] The intravascular device 102 includes a flexible elongated member 106. An electronic component 112 is disposed at a distal portion 107 of the flexible elongated member 106. In some embodiments, the electronic component 112 may be mounted within a housing 280 at the distal portion 107. A flexible tip coil 290 extends distally from the housing 280 at the distal portion 107 of the flexible elongated member 106. A connection portion 114 located at the proximal end of the flexible elongated member 106 includes conductive portions 132, 134. In some embodiments, the conductive portions 132, 134 may be conductive ink printed and / or deposited around the connection portion 114 of the flexible elongated member 106. In some embodiments, the conductive portions 132, 134 are conductive metal rings positioned around the flexible elongated member. A locking portion is formed by a collar 118, and a knob 120 is disposed at a proximal portion 109 of the flexible elongated member 106.

[0036] Figure 1 The intravascular device 102 includes a distal core 210 and a proximal core 220. The distal core 210 and proximal core 220 are metallic components forming the main body of the intravascular device 102. For example, the distal core 210 and proximal core 220 are flexible metallic rods providing structure for a flexible, elongated member 106. The diameters of the distal core 210 and proximal core 220 may vary along their length. The connector between the distal core 210 and proximal core 220 is surrounded and contained by a hypotube 215.

[0037] In some embodiments, the intravascular device 102 includes a distal and a proximal assembly electrically and mechanically connected together, providing electrical communication between the electronics 112 and the conductive portions 132, 134. For example, flow data obtained by the electronics 112 (in this example, the electronics 112 is a flow sensor) can be transmitted to the conductive portions 132, 134. Control signals (e.g., operating voltage, start / stop commands, etc.) from the processor system 306 communicating with the intravascular device 102 can be transmitted to the electronics 112 via a connector 314 attached to the conductive portions 132, 134. The distal subassembly may include a distal core 210. The distal subassembly may also include the electronics 112, a multifilament conductor bundle 230, and / or one or more layers of insulating polymer / plastic 240 surrounding the conductive member 230 and the core 210. For example, one or more polymer / plastic layers may insulate and protect the conductive member of the multifilament cable or conductor bundle 230. The proximal subassembly may include a proximal core 220. The proximal subassembly may also include one or more polymer layers 250 (hereinafter referred to as polymer layers 250) surrounding the proximal core 220 and / or embedded within one or more insulating and / or protective polymer layers 250. In some embodiments, the proximal and distal subassemblies may be manufactured separately. During the assembly process for the intravascular device 102, the proximal and distal subassemblies may be electrically and mechanically connected together. As used herein, a flexible elongated member may refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220, etc.), and / or one or more components of the distal subassembly 210 (e.g., including the distal core 210, etc.). The connector between the proximal core 220 and the distal core 210 is surrounded by a thiopanle 215.

[0038] In various embodiments, the intravascular device 102 may include one, two, three, or more core wires extending along its length. For example, in one embodiment, a single core wire extends substantially along the entire length of the flexible elongated member 106. In such an embodiment, locking portions 118 and 120 may be integrally formed at the proximal portion of the single core wire. Electronic components 112 may be secured at the distal portion of the single core wire. In other embodiments, such as Figure 1In the embodiment illustrated, locking portions 118 and 120 may be integrally formed at the proximal portion of the proximal core 220. Electronic component 112 may be secured at the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members in a multifilament conductor bundle 230 communicating with the electronic component 112. For example, the conductor bundle 230 may include one or more wires in direct communication with the electronic component 112. In some instances, the conductive member 230 is electrically and mechanically coupled to the electronic component 112, for example, by soldering. In some instances, the conductor bundle 230 includes two or three wires (e.g., a two-wire cable or a three-wire cable). Individual wires may include bare metal conductors or metal conductors surrounded by one or more insulating layers. The multifilament conductor bundle 230 may extend along the length of the distal core 210. For example, at least a portion of the conductive member 230 may be helically or spirally wound around the entire length of the distal core 210 or a portion of the length of the distal core 210.

[0039] The intravascular device 102 includes one or more conductive strips 260 at the proximal portion of a flexible elongated member 106. The conductive strips 260 are embedded within one or more polymer layers 250. The conductive strips 260 are in direct communication with conductive portions 132 and / or 134. In some instances, a multifilament conductor bundle 230 is electrically and mechanically coupled to electronic components 112, for example, by welding. In some instances, conductive portions 132 and / or 134 include conductive ink (e.g., metallic nano-inks, such as silver or gold nano-inks) directly deposited or printed onto the conductive strips 260.

[0040] As described herein, electrical communication between the conductive member 230 and the conductive strip 260 can be established at the connection portion 114 of the flexible elongated member 106. By establishing electrical communication between the conductor bundle 230 and the conductive strip 260, the conductive portions 132 and 134 can communicate with the electronic component 112.

[0041] In the Figure 1 In some embodiments shown, the intravascular device 102 includes a locking portion 118 and a portion 120. To form the locking portion 118, a machining process is required to remove the polymer layer 250 and the conductive strip 260 from the locking portion 118 and to shape the proximal core 220 in the locking portion 118 into the desired shape. Figure 1As shown, locking portion 118 includes a reduced diameter, while portion 120 has a diameter substantially similar to that of the proximal core 220 in connecting portion 114. In some instances, due to the removal of the conductive strip in locking portion 118 by a machining process, the proximal end of conductive strip 260 will be exposed to moisture and / or liquids, such as blood, saline solutions, disinfectants, and / or enzyme cleaning solutions. An insulating layer 158 is formed on the proximal end portion of connecting portion 114 to insulate the exposed conductive strip.

[0042] In some embodiments, connector 314 provides an electrical connection between conductive portions 132, 134 and the patient interface module or monitor 304. In some cases, the patient interface module (PIM) 304 may be connected to or communicate with a console or processing system 306, which includes or communicates with a display 308. In some embodiments, the patient interface module 304 includes signal processing circuitry, such as analog-to-digital converters (ADCs), analog and / or digital filters, signal conditioning circuitry, and any other suitable signal processing circuitry for processing signals provided by the electronics 112 for use by the processing system 306.

[0043] System 100 can be deployed in a catheter insertion laboratory with a control room. Processing system 306 can be located in the control room. Alternatively, processing system 306 can be located anywhere else, such as within the catheter insertion laboratory itself. The catheter insertion laboratory may include a sterile area, and its associated control room may or may not be sterile, depending on the procedure to be performed and / or the healthcare facility. In some embodiments, device 102 can be controlled from a remote location, such as a control room, so that the operator does not need to be in close proximity to the patient.

[0044] The intraluminal device 102, PIM 304, and display 308 can be directly or indirectly communicatively coupled to the processing system 306. These components can be communicatively coupled to the medical processing system 306 via wired connections such as a standard copper multifilament conductor bundle 230. The processing system 306 can be communicatively coupled to one or more data networks, such as a TCP / IP-based local area network (LAN). In other embodiments, different protocols, such as Synchronous Fiber Network (SONET), can be utilized. In these cases, the processing system 306 can be communicatively coupled to a wide area network (WAN).

[0045] The PIM 304 transmits the received signal to the processing system 306, where the information is processed and displayed on the display 308. The console or processing system 306 may include a processor and memory. The processing system 306 may be operable to facilitate the features of the intravascular sensing system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-transient tangible computer-readable medium.

[0046] PIM 304 facilitates signal communication between processing system 306 and in-lumen device 102. In some embodiments, PIM 304 performs preliminary data processing before relaying the data to processing system 306. In examples of such embodiments, PIM 304 performs data amplification, filtering, and / or aggregation. In embodiments, PIM 304 also supplies high and low voltage DC power via multifilament conductor bundle 230 to support the operation of in-lumen device 102.

[0047] Multifilament cable or transmission harness 230 may include multiple conductors, including one, two, three, four, five, six, seven, or more conductors. The multifilament conductor bundle 230 may be positioned along the outside of the distal core 210. The multifilament conductor bundle 230 and the distal core 210 may be coated with an insulating and / or protective polymer 240. Figure 1 In the example shown, the multifilament conductor bundle 230 includes: two straight portions 232 and 236, wherein the multifilament conductor bundle 230 extends linearly and parallel to the longitudinal axis of the flexible elongated member 106 outside the distal core 210; and a helical or spiral portion 234, wherein the multifilament conductor bundle 230 is wound around the outside of the distal core 210. In some embodiments, the multifilament conductor bundle 230 includes only the straight portions or only the helical or spiral portions. Typically, the multifilament conductor bundle 230 may extend in a linear, wound, non-linear, or unwound manner, or any combination thereof. Communication along the multifilament conductor bundle 230 (if any) may be carried out by a number of methods or protocols, including serial, parallel, and other methods, wherein one or more filaments in the bundle 230 carry signals. One or more filaments of the multifilament conductor bundle 230 may also carry direct current (DC) power, alternating current (AC) power, or be used as an electrical ground connection.

[0048] The display or monitor 308 may be a display device, such as a computer monitor, a touchscreen display, a television screen, or any other suitable type of display. The monitor 308 may be used to display selectable prompts, instructions, and visualizations of imaging data to the user. In some embodiments, the monitor 308 may be used to provide the user with a process-specific workflow for completing an intraluminal imaging procedure.

[0049] Before proceeding, it should be noted that the examples described above are provided for illustrative purposes and are not intended to be limiting. Other devices and / or device configurations can be used to perform the operations described herein.

[0050] Figure 2This is a side view of an example electronic component 112 of an intravascular device 102 according to an aspect of this disclosure. For example, the electronic component 112 may be a pressure sensor, a flow sensor, a temperature sensor, or other sensors configured to measure blood flow parameters within a patient's blood vessels. In an exemplary embodiment, the flow sensor is a single ultrasonic transducer element. The transducer element emits an ultrasonic signal and receives ultrasonic echoes reflected from anatomical structures, such as flowing fluids, like blood. The transducer element generates an electrical signal representing the echo. A signal-carrying filament carries this electrical signal from a sensor at a distal portion to a connector at a proximal portion. A processing system processes the electrical signal to extract the flow rate of the fluid. In other embodiments, the device 102 can be used to examine any number of anatomical locations and tissue types, including but not limited to organs including the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and valves, ventricles, or other parts of the heart within the bloodstream, and / or other systems of the body. In addition to natural structures, device 102 can be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices. In some embodiments, electronic components 112 may include imaging components (e.g., intravascular ultrasound imaging components), measurement components (e.g., pressure, flow, or temperature sensors), and / or treatment components (e.g., ablation components). In some embodiments, electronic components 112 may be wholly or partially enclosed within housing 280. In some embodiments, electronic components are located at or near the distal end of a flexible elongated member and may include a distal tip 108 (e.g., a non-invasive tip). In some embodiments, one or more electronic components may be located on the distal portion of the flexible elongated member. For example, one or more electronic components may be located at the distal tip (where the leading edge and / or distal portion of the flexible elongated member terminates) or proximally spaced from the distal end (e.g., 0.5 cm, 1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, and / or other suitable values ​​larger and smaller). Some embodiments of the intraluminal device 102 include multiple different electronic components (e.g., pressure sensors and flow sensors, or any other number or combination of sensors). In such embodiments, the first electronic component may be positioned at the distal tip of the flexible elongated member, and the second electronic component may be spaced apart from the distal tip and / or the first electronic component (e.g., 0.5 cm, 1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, and / or other suitable values ​​larger and smaller). In some embodiments, power, control signals, and electrical grounding or signal return may be provided by the multifilament conductor bundle 230. Figure 2 In the example, the multi-filament conductor bundle 230 is shown as a twin-filament bundle with two conductive filaments 310 and 330. The conductive filaments 310 and 330 can be made, for example, pure copper or a copper alloy such as BeCu or AgCu.

[0051] Figure 3 This is a perspective view of a multi-filament conductor bundle 230 according to an aspect of this disclosure. Figure 3 In the example shown, the multifilament conductor bundle 230 is a three-filament bundle comprising three conductors 310, 320, and 330, surrounded by insulating sheaths 315, 325, and 335, respectively. The insulating sheaths can be made, for example, of polyimide. An additional outer coating 340 can be applied, for example, by impregnation, although other methods may be used alternatively or additionally. In a conventional three-filament bundle, all three conductors can have the same or similar diameters and can be made of pure copper or a copper alloy such as BeCu. Although the multifilament conductor bundle 230 is shown here with the conductors arranged side-by-side in a planar manner, those skilled in the art will recognize that other arrangements may be used alternatively or additionally.

[0052] In the illustrated embodiment, the second wire 320 comprises a different material from the first wire 310 and the third wire 330. In this aspect, the second wire 320 may comprise a material having a relatively higher strength than the wires 310 and 330. For example, the second wire 320 may comprise stainless steel or a high-strength copper alloy, while the conductive wires 310 and 330 comprise other copper alloys or pure copper.

[0053] Figure 4 This is a cross-sectional view of a multi-filament conductor bundle 230 according to at least one embodiment of the present disclosure. Figure 4 In the example shown, the multi-filament conductor bundle 230 is a three-filament bundle comprising two conductive filaments 310 and 330, which are surrounded by insulating sheaths 315 and 335, respectively. Figure 4 In the example shown, the central filament of bundle 230 is a reinforcing filament 420, which may be, for example, made of a material (e.g., stainless steel) having a higher tensile strength and / or a higher yield strength than the conductive material (e.g., copper or BeCu) of conductive filaments 310 and 330. The reinforcing filament 420 may include an insulating sheath 425. In other embodiments, the reinforcing filament 420 does not include an insulating sheath 425. The multifilament conductor bundle 230 may or may not include an additional outer coating 340, such as nylon or polyurethane, which connects the separate insulators 315, 325, and 335 together, such that the filaments 310, 320, and 330 form a single connected conductor bundle 230. In some embodiments, the conductive filaments 310 and 330 (instead of the reinforcing filaments) are surrounded by insulating sheaths 315 and 335, and the multifilament conductor bundle 230 is covered with an outer coating 340.

[0054] Adding reinforcing wires 420 with high tensile strength or high yield strength can increase the overall tensile strength of the multi-filament bundle 230 while maintaining the desired electrical properties for the conductive wires 310 and 330. This can, for example, allow pure copper to be used instead of copper alloys (such as BeCu or AgCu) for the conductive wires 310 and 330 without compromising the mechanical strength of the multi-filament conductor bundle 230, and in which the risk of elongation and necking that could break the wires or limit their current-carrying capacity is greatly reduced.

[0055] In some embodiments, the reinforcing wire 420 is not connected to electrical terminals at one or both ends of the multi-wire conductor bundle. High-strength stainless steel can have a substantially low conductivity (e.g., 3-15% of the conductivity of pure copper), making it less desirable as an electrical conductor. However, in other instances, the reinforcing wire 430 can be used as a conductor for certain applications. For example, in wires that do not require carrying large currents or high-frequency signals (e.g., signal grounding wires), the low conductivity of the reinforcing material (e.g., stainless steel) may be acceptable.

[0056] Other materials, regardless of whether they are conductive, can be used as a substitute for or supplement to stainless steel. Figure 4 In the example shown, the multi-filament conductor bundle 230 is depicted as having three filaments arranged side-by-side in a planar manner. However, other arrangements and numbers of filaments, whether conductive or reinforcing, may be used alternatively or additionally. Furthermore, although the filaments are shown as circular in cross-section, some or all of the filaments may be elliptical, rectangular, or curved in cross-section to minimize the profile of the multi-filament conductor bundle against the guidewire, conduit, or other device.

[0057] In some embodiments, the insulating sheaths 315, 335, and 425 may be omitted. In such embodiments, the outer coating 340 may provide electrical isolation between the conductive wires 310, 330, and / or the reinforcing wires 420.

[0058] Figure 5 This is a cross-sectional view of a multi-filament conductor bundle 230 according to at least one embodiment of the present disclosure. Figure 5 In the example shown, the multi-filament conductor bundle 230 is a three-filament bundle, comprising two conductive wires 310 and 330 respectively surrounded by insulating sheaths 315 and 335. Figure 5 In the example shown, the left outer wire of bundle 230 may or may not include the reinforcing wire 420 of the insulating sheath 425. The reinforcing wire 420 can be located in any suitable position (e.g., left position, right position, outer position, center position, etc.). The multi-wire conductor bundle 230 may or may not include the additional outer coating 340 that connects the wires together to form a single conductor bundle 230. Figure 5In the example shown, the multi-filament conductor bundle 230 is depicted as having three filaments arranged side-by-side in a planar manner. However, other arrangements and numbers of filaments, whether conductive or reinforcing, may be used alternatively or additionally.

[0059] Figure 6 This is a cross-sectional view of a multi-filament conductor bundle 230 according to at least one embodiment of the present disclosure. Figure 6 In the example shown, the multi-filament conductor bundle 230 is a three-filament bundle, comprising two conductive wires 310 and 330 respectively surrounded by insulating sheaths 315 and 335. Figure 7 In the example shown, the center wire of bundle 230 may or may not include the reinforcing wire 420, which is an insulating sheath 425. In this example, the multi-wire conductor bundle 230 does not include the additional outer coating 340 that connects the wires together. However, the wires 310, 330, and 420 may be bundled, braided, or otherwise coupled to each other, or may simply be routed in a parallel but separate manner, wherein the reinforcing wire 420 helps prevent the conductive wires 310 and 330 from elongating or necking during tensioning. Figure 6 In the example shown, the multi-filament conductor bundle 230 is depicted as having three filaments arranged side-by-side in a planar manner. However, other arrangements and numbers of filaments, whether conductive or reinforcing, may be used alternatively or additionally.

[0060] Figure 7 This is a cross-sectional view of a multi-filament conductor bundle 230 according to at least one embodiment of the present disclosure. Figure 5 In the example shown, the multi-filament conductor bundle 230 is a three-filament bundle, comprising two conductive wires 310 and 330 respectively surrounded by insulating sheaths 315 and 335. Figure 7 In the example shown, the left outer wire of bundle 230 may or may not include reinforcing wire 420 with an insulating sheath 425. In this example, the multi-wire conductor bundle 230 does not include an additional outer coating 340 that connects the wires together. However, wires 310, 330, and 420 may otherwise be coupled to each other or routed in a parallel but separate manner, wherein reinforcing wire 420 helps prevent conductive wires 310 and 330 from elongating or necking. Figure 7 In the example shown, the multi-filament conductor bundle 230 is depicted as having three filaments arranged side-by-side in a planar manner. However, other arrangements and numbers of filaments, whether conductive or reinforcing, may be used alternatively or additionally.

[0061] Figure 8 This is a cross-sectional view of a multi-filament conductor bundle 230 according to at least one embodiment of the present disclosure. Figure 8In the example shown, the multi-filament conductor bundle 230 is a three-filament bundle, comprising two conductive wires 310 and 330 respectively surrounded by insulating sheaths 315 and 335. Figure 5 In the example shown, one of the wires in bundle 230 may or may not include reinforcing wire 420 with insulating sheath 425. Multi-wire conductor bundle 230 may or may not include additional outer coating 340 that joins the wires together to form a single connected conductor bundle 230. Figure 5 In the example shown, the multi-filament conductor bundle 230 is depicted as having three filaments arranged in a triangular pattern. However, other arrangements and numbers of filaments, whether conductive or reinforcing, may be used alternatively or additionally. While a flat (side-by-side) arrangement of conductors can minimize the profile of the conductor bundle against a conduit, guidewire, or other device, a stacked (e.g., triangular, rectangular, etc.) arrangement may be advantageous or desirable for other reasons, depending on the implementation.

[0062] Figure 9 This is a cross-sectional view of a multi-filament conductor bundle 230 according to at least one embodiment of the present disclosure. Figure 9 In the example shown, the multi-filament conductor bundle 230 is a three-filament bundle, comprising two conductive wires 310 and 330 respectively surrounded by insulating sheaths 315 and 335. Figure 9 In the example shown, the central filament of bundle 230 is a reinforcing filament 420 having a diameter larger than that of conductive filaments 310 and 330. In the illustrated embodiment, the reinforcing filament 420 comprises a different material having a relatively higher strength than the material used for conductive filaments 310 and 330, and is surrounded by an insulating sheath 425. In other embodiments, the reinforcing filament 420 is made of the same material as the conductive filaments 310 and 330. In some embodiments, the reinforcing filament 420 does not include the insulating sheath 425. The multi-filament conductor bundle 230 may or may not include an additional outer coating 340 that joins the filaments together to form a single conductor bundle 230.

[0063] The tensile strength or yield strength of the wire may depend on its composition. The total force required to elongate, neck, or otherwise deform the wire can depend on the wire diameter, and therefore the addition of a reinforcing wire 420 with a larger diameter than the conductive wires 310 and 330 can increase the total force on the multifilament bundle 230, which is required to elongate or neck the conductive wires of the multifilament bundle 230. Figure 9In the example shown, the multi-filament conductor bundle 230 is depicted as having three filaments arranged side-by-side in a planar manner. However, other arrangements and numbers of filaments, whether conductive or reinforcing, may be used alternatively or additionally. While a flat (side-by-side) arrangement of conductors of the same size can minimize the profile of the conductor bundle against the conduit or guidewire, for other reasons, one or more conductors with larger diameters may be advantageous or desirable, depending on the implementation.

[0064] Figure 10 This is a schematic side view of an intravascular device 102 including a reinforced multifilament conductor bundle 230 according to at least one embodiment of the present disclosure. Proximal core wire 220 and distal core wire 210 are visible, connected by a hypotube 215. At the distal end of the distal core wire is a coil 290, which terminates with an electronics 112 that can be completely or partially enclosed within a housing 280. Also visible is the reinforced multifilament conductor bundle 230 including conductive wires 310 and 330 and reinforcing wire 420.

[0065] Conductive wires 310 and 330 connect electronic component 112 to electrical contacts 1010 formed on conductive strip 260, which makes electrical contact with conductive regions 132 and 134. A reinforced multifilament conductor bundle 230 includes a straight region 232 passing through coil 290. The reinforced multifilament conductor bundle 230 also includes a helical region 234 wound around distal core wire 210 and coated with an insulating or protective polymer coating 240. In the helical region 234, the wires 310, 320, and 330 of the bundle extend parallel to each other around distal core wire 210, such that the helical shape formed by the wires 310, 320, and 330 is concentric with distal core wire 210. The wires 310, 320, and 330 are shown extending in contact with each other. In this respect, the wires 310, 320, and 330 may be attached to each other or not, such that the wires 310, 320, and 330 extend adjacent to each other. The reinforced multi-wire conductor bundle 230 additionally includes a straight region 236 passing through the hysteresis tube 215. Between the hysteresis tube 215 and the electrical contact 1010, the conductive wires are coated with a polymer coating 250. In some embodiments, the electrical contact 1010 is formed by removing (e.g., etching, ablating) portions of the outer insulating coating or layer covering the strip 260 and soldering the conductive wires 310 and 330 to the strip 260.

[0066] exist Figure 10In the example shown, the reinforcing wire 420 is present within the multi-wire conductor bundle 230 in the helical region 234, but not in the straight regions 232 and 236. The distal end of the reinforcing wire 420 terminates at position 1020. Position 1020 is proximal to the distal end of the distal core wire 210. Position 1020 can be aligned, for example, with the position of the tapered start at the distal portion of the distal core wire 210. The proximal end of the reinforcing wire 420 terminates at position 1030. Position 1030 is distal to the proximal end of the distal core wire 210. Position 1030 can be aligned, for example, with the position of the tapered start at the proximal portion of the distal core wire 210. The reinforcing wire can be clamped, shaving, or bent, for example, at positions 1020 and 1030, such that it is separated from the conductive wires 310 and 320 at these positions. This allows it to provide strength to the multi-wire conductor bundle 230 in densely processed areas (such as the spiral region 234) without interfering with the fine assembly operations at the electrical terminations and without adding unwanted stiffness to the coil 290. The multi-wire conductor bundle 230 can also be more easily fed via some coupling after the reinforcing wire 420 is removed.

[0067] Figure 11 This is a schematic side view of an intravascular device 102 including a multifilament conductor bundle 230 according to at least one embodiment of the present disclosure. Proximal core wire 220 and distal core wire 210 are visible, connected by a hypotube 215. At the distal end of the distal core wire is a coil 290, which terminates with an electronics 112 completely or partially enclosed in a housing 280. Also visible is a reinforced multifilament conductor bundle 230 including conductive wires 310 and 330 and reinforcing wire 420.

[0068] Conductive wires 310 and 330 connect electronic component 112 to electrical contact portion 1010 formed on conductive strip 260, which makes electrical contact with conductive regions 132 and 134. A reinforced multifilament conductor bundle 230 includes a straight region 232 passing through coil 290. The reinforced multifilament conductor bundle 230 also includes a spiral region 234 wound around distal core wire 210 and coated with polymer coating 240. The reinforced multifilament conductor bundle 230 additionally includes a straight region 236 passing through hysteresis tube 215. Between hysteresis tube 215 and electrical contact portion 1010, the conductive wires are coated with polymer coating 250.

[0069] exist Figure 11 In the example shown, the reinforcing wire 420 is present in the helical region 234 and also in the straight regions 232 and 236, but has no electrical termination at either end. In other embodiments, the reinforcing wire 420 may be used as a conductor and may be electrically terminated, for example, at an electronic device at its distal end and at an electrical connection 1010 at its proximal end.

[0070] Figure 12 This is a schematic diagram of a processor circuit 1250 according to at least one embodiment of the present disclosure. The processor circuit 1250 may be implemented in an intravascular sensing system 100, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as required for implementing the method. As shown, the processor circuit 1250 may include a processor 1260, a memory 1264, and a communication module 1268. These components may communicate directly or indirectly with each other, for example, via one or more buses.

[0071] Processor 1260 may include any combination of a central processing unit (CPU), digital signal processor (DSP), ASIC, controller, or general-purpose computing device, reduced instruction set computing (RISC) device, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other related logic device, including mechanical or quantum computers. Processor 1260 may also include another hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 1260 may also be implemented as a combination of computing devices (e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors incorporating a DSP core, or any other such configuration).

[0072] Memory 1264 may include cache memory (e.g., the cache memory of processor 1260), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In embodiments, memory 1264 includes a non-transient computer-readable medium. Memory 1264 may store instructions 1266. Instructions 1266 may include instructions that, when executed by processor 1260, cause processor 1260 to perform the operations described herein. Instructions 1266 may also be referred to as code. The terms “instruction” and “code” should be broadly interpreted to include any type of computer-readable statement(s). For example, the terms “instruction” and “code” may refer to one or more programs, routines, subroutines, functions, flows, etc. “Instruction” and “code” may include a single computer-readable description or many computer-readable descriptions.

[0073] Communication module 1268 may include any electronic and / or logic circuitry that facilitates direct or indirect data communication between processor circuitry 1250 and other processors or devices. In this respect, communication module 1268 may be an input / output (I / O) device. In some instances, communication module 1268 facilitates direct or indirect communication between various components of processor circuitry 1250 and / or the intravascular measurement system 100. Communication module 1268 may communicate within processor circuitry 1250 via a variety of methods or protocols. Serial communication protocols may include, but are not limited to, US SPI, I... 2 C. Serial and parallel communication may be carried out using methods or protocols such as RS-232, RS-485, CAN, Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communication may be bridged by UART, USART, or other suitable subsystems.

[0074] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and the central server, or readings from ultrasound equipment) can be implemented using any suitable wireless or wired communication technology, such as cable interfaces like USB, micro USB, Lightning, or FireWire, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections like 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G. For example, Bluetooth Low Energy (BLE) radio can be used to establish connectivity with cloud services, for data transfer, and for receiving software patches. The controller can be configured to communicate with remote servers or local devices (such as laptops, tablets, or handheld devices), or may include a display capable of showing status variables and other information. Information can also be transferred on physical media such as USB flash drives or memory sticks.

[0075] Figure 13 This is a cross-sectional view of a multi-filament conductor bundle 230 according to at least one embodiment of the present disclosure. Figure 13 In the example shown, the multi-filament conductor bundle 230 is a four-filament bundle, comprising two conductive wires 310 and 330 respectively surrounded by insulating sheaths 315 and 335. Figure 13 In the example shown, the two central wires of the bundle 230 are reinforcing wires 420, each of which may or may not include an insulating sheath 425. The multi-wire conductor bundle 230 may or may not include an additional outer coating 340 that connects the wires together to form a single conductor bundle 230.

[0076] Therefore, it can be seen that reinforced multifilament conductor bundles advantageously increase the strength of multifilament conductor bundles that can be used to manufacture small electronic devices such as intravascular medical catheters and guidewires. Several variations are possible with respect to the examples and embodiments described above. For example, multiple reinforcing filaments of the same or different types may be included in the multifilament conductor bundle, or all the filaments in the multifilament conductor bundle or cable may be reinforcing filaments.

[0077] The logical operations constituting embodiments of the technology described herein are referred to differently as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that, unless otherwise expressly claimed, these can be arranged or performed in any order or a specific order required by the language of the claims. It should also be understood that the described technology can be used in single-purpose and multi-purpose electrical and electronic devices for medical or non-medical purposes.

[0078] All directional references, such as up, down, inside, outside, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, near, and far, are used only for identification purposes to aid the reader's understanding of the claimed subject matter and do not impose any particular limitation on the location, orientation, or use of the reinforced multi-filament conductor bundle. Unless otherwise indicated, connection references, such as attachment, coupling, connection, and combination, are to be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. Thus, a connection reference does not necessarily imply that two elements are directly and in a fixed relationship connected to each other. The term "or" should be interpreted as meaning "and / or" rather than "exclusive." The word "comprising" does not exclude other elements or steps, and the words "a" or "an" do not exclude multiple. In the claims, unless otherwise indicated, state values ​​should not be interpreted merely as illustrative and should not be construed as restrictive.

[0079] The foregoing descriptions, examples, and data provide a complete description of the structure and the use of exemplary embodiments of the reinforced multifilament conductor bundle as defined in the claims. While various embodiments of the claimed subject matter have been described above with some degree of specificity or by reference to one or more individual embodiments, many modifications can be made to the disclosed embodiments by those skilled in the art without departing from the spirit or scope of the claimed subject matter.

[0080] However, other embodiments are still contemplated. It should be understood that all substances included in the above description and shown in the accompanying drawings should be interpreted as illustrative of particular embodiments only and not as limiting. Changes in detail or structure may be made without departing from the essential elements of the subject matter as defined in the claims.

Claims

1. An intraluminal sensing guidewire, comprising: A flexible elongated member configured to be positioned within a patient's body lumen, wherein the flexible elongated member includes a metal core wire extending along a longitudinal axis; A sensing element is disposed at the distal portion of the flexible elongated member and configured to acquire physiological data when positioned within the body lumen. An electrical connector is disposed on the proximal portion of the flexible elongated member; and A wire bundle, disposed between the sensing element and the electrical connector, the wire bundle comprising: A first conductive wire, comprising a first material strength, wherein the first conductive wire is in electrical communication with a sensing element and the electrical connector; and The first reinforcing filament includes a second material with a strength greater than that of the first material. The filament bundle includes a helical portion and a non-helical portion, wherein the first reinforcing filament crosses the helical portion and terminates at both the distal end and the proximal end located within the helical portion.

2. The intraluminal sensing guidewire according to claim 1, wherein, The first conductive wire and the first reinforcing wire extend side by side around the metal core wire in a spiral manner in the spiral portion.

3. The intraluminal sensing guidewire according to claim 1, wherein, The wire bundle also includes a second conductive wire, the second conductive wire having the same strength as the first material, wherein the second conductive wire is in electrical communication with the sensing element and the electrical connector.

4. The intraluminal sensing guidewire according to claim 1, wherein, The wire bundle also includes a second reinforcing wire, which has the second material strength.

5. The intraluminal sensing guidewire according to claim 1, wherein, The first reinforcing wire and / or the first conductive wire includes an insulating coating.

6. The intraluminal sensing guidewire according to claim 3, wherein, The sensing element is a flow sensor, and wherein the first conductive wire, the second conductive wire, and the reinforcing wire extend side by side with each other in a helical manner around at least a portion of the length of the metal core wire.

7. The intraluminal sensing guidewire according to claim 1, wherein, The wire bundle also includes an external coating that mechanically couples the first conductive wire to the first reinforcing wire along at least a portion of the length of the first conductive wire and the first reinforcing wire.

8. The intraluminal sensing guidewire according to claim 1, wherein, The first conductive wire comprises copper and / or the first reinforcing wire comprises stainless steel.

9. The intraluminal sensing guidewire according to claim 1, wherein, The first reinforcing wire has a cross-sectional diameter larger than that of the first conductive wire.

10. The intraluminal sensing guidewire according to claim 1, wherein, The length of the first reinforcing wire is less than the length of the first conductive wire.

11. The intraluminal sensing guidewire according to claim 1, wherein, In the non-spiral portion, the first conductive wire extends longitudinally along the length of the flexible elongated member toward at least one electrical contact, wherein the first conductive wire is electrically connected via the electrical contact to a conductive strip embedded within the flexible elongated member.

12. A method for assembling an intraluminal sensing guidewire, comprising: A flexible elongated member is provided, the flexible elongated member being configured to be positioned within a patient's body lumen, wherein the flexible elongated member includes a metal core wire extending along a longitudinal axis; A sensing element is attached to the distal portion of the flexible elongated member, wherein the sensing element is configured to acquire physiological data when positioned within the body lumen. The electrical connector is attached to the proximal portion of the flexible elongated member; Assemble a wire bundle, wherein assembling the wire bundle includes coupling a conductive wire to a reinforcing wire, wherein the conductive wire has a first material strength, and wherein the reinforcing wire has a second material strength greater than the first material strength; The wire bundle is wound in a spiral manner around the metal core wire; and At least the conductive wires of the wire bundle are coupled to the sensing element and the electrical connector. The filament bundle includes a helical portion and a non-helical portion, and the reinforcing filament crosses the helical portion and terminates at both the distal end and the proximal end located within the helical portion.

13. The method according to claim 12, wherein, Assembling the wire bundle includes attaching the conductive wires to the reinforcing wires.

14. The method according to claim 13, wherein, Attaching the conductive wire to the reinforcing wire includes attaching the insulating coating of the conductive wire to the insulating coating of the reinforcing wire, or forming an insulating layer around the conductive wire and the reinforcing wire.

15. The method according to claim 12, wherein, Winding the wire bundle around the metal core in the spiral manner includes winding the wire bundle around a first portion of the metal core in the spiral manner, and wherein the method further includes coupling the wire bundle to the flexible elongated member such that the wire bundle extends linearly along different second portions of the metal core.

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