Physiological sensing intracavitary devices with reinforced polyfilament bundles and related devices, systems and methods - Patent Application 20070122997

Abstract

An intraluminal sensing guidewire is provided for acquiring physiological data within a body lumen of a patient. The guidewire includes a flexible elongate member configured to be disposed within a body lumen. The flexible elongate member includes a metal core wire extending along a longitudinal axis. The guidewire also includes a sensing element for acquiring physiological data at a distal portion of the flexible elongate member, an electrical connector at a proximal portion of the flexible elongate member, and a filament bundle disposed between the sensing element and the electrical connector. The filament bundle includes conductive filaments in electrical communication with the sensing element and the electrical connector. The bundle also includes reinforcing filaments having a material strength greater than that of the conductive filaments.

Description

[Technical Field]

[0001] The subject matter described herein relates to an apparatus and method for improving the strength of fine gauge multifilament electrical wire bundles in physiological sensing intraluminal devices, the reinforced multifilament conductor bundles being particularly, but not exclusively, useful for intravascular catheters and guidewires. [Background technology]

[0002]

[0002] The term "filament" is a noun referring to a thin thread, wire, or fiber. Thin electrical wires may be referred to as filaments. Small diameter medical devices such as intraluminal (e.g., intravascular) catheters and guidewires incorporate sensors (e.g., pressure, temperature, flow, or imaging sensors) that are powered and communicate with the sensors via multifilamentary (e.g., bifilar, trifilar, etc.) electrical conductor bundles. The reduction in device dimensions poses challenges in the device manufacturing process related to routing, wrapping, and anchoring of multifilamentary electrical conductor bundles.

[0003] Current medical devices, such as guidewires and catheters, typically use bundles of electrical filaments, typically two, three, or more conductive filaments, to make electrical connections between electrical components, such as sensors or transducers, and contacts. To make these connections, the filaments may be wrapped or pulled along the length of the device from one end to the other. Pure copper and many copper alloys have very low tensile and yield strengths, so the mechanical strength of conventional filaments is low. The manufacturing process for intraluminal catheter or guidewire devices can involve wrapping or stretching multifilament conductor bundles, which requires tension. Unfortunately, when this tension exceeds a threshold longitudinal force, it plastically deforms the conductive filaments, which can result in undesirable stretching and / or necking, for example, up to 100% elongation in some current processes. The associated narrowing of the conductors affects both the mechanical and electrical performance of the filaments, which can lead to manufacturing defects.

[0004]

[0004] The information contained in the background section of this specification, including any references cited in this specification and their descriptions or discussions, is included for technical reference purposes only and should not be considered as a subject matter by which the scope of this disclosure should be bound. summary Summary of the Invention [Problem to be solved by the invention]

[0005]

[0005] Disclosed is an intraluminal device including a reinforced multifilamentary conductor bundle with improved mechanical characteristics and properties. For example, improved tensile strength can reduce stretching and necking of fine-gauge filaments during the medical device manufacturing process, thus reducing manufacturing defects. The inclusion of reinforcing filaments can reduce or eliminate plastic deformation of the multifilamentary conductor bundle while maintaining required electrical properties. [Means for solving the problem]

[0006] In some currently used devices, higher strength alternative copper alloys (e.g., beryllium copper, or BeCu) are sometimes used instead of pure copper for the filaments in multifilamentary conductor bundles. However, these materials have only about 15-50% of the conductivity of pure copper, which can reduce the maximum current the filaments can conduct. Therefore, the present disclosure addresses this issue by maintaining pure copper, high-conductivity copper alloys, or other high-conductivity materials for the majority of the filaments in the multifilamentary conductor bundle, but adding reinforcing filaments (or substituting one of the lower-strength conductive filaments) made of a high-strength material, such as stainless steel. The reinforcing filaments may or may not have an insulating coating and may or may not be of a different gauge than the other filaments in the bundle. Any manufacturing or assembly process involving tensioning of the multifilamentary conductor bundle will benefit from the reinforced multifilamentary conductor bundle of the present disclosure. Depending on the implementation, the reinforcing filaments may be used as conductors in an electrical circuit, or may run alongside but not electrically connect to other electrical filaments.

[0007] The reinforced multifilament conductor bundles disclosed herein are particularly, but not exclusively, useful for intraluminal medical catheters and guidewires. One general aspect of the reinforced multifilament conductor bundle includes an intraluminal sensing guidewire. The intraluminal sensing guidewire includes a flexible elongate member configured for placement within a body cavity of a patient, the flexible elongate member having a metal core wire extending along a longitudinal axis; a sensing element disposed at a distal portion of the flexible elongate member and configured to acquire physiological data while disposed within the body cavity; and an electrical connector (electrical contacts) disposed at a proximal portion of the flexible elongate member. The intraluminal sensing guidewire also includes a filament bundle disposed between the sensing element and the electrical connector, the filament bundle including first conductive filaments having a first material strength, the first conductive filaments in electrical communication with the sensing element and the electrical connector; and reinforcing filaments having a second material strength greater than the first material strength.

[0008]

[0008] The implementation may include one or more of the following features. In some embodiments, the first conductive filaments and the first reinforcing filaments extend side by side in a helical manner around the metal core wire. In some embodiments, the filament bundle further includes second conductive filaments having the first material strength, the second conductive filaments being in electrical communication with the sensing element and the electrical connector. In some embodiments, the filament bundle further includes second reinforcing filaments having the second material strength. In some embodiments, the first reinforcing filaments have an insulating coating. In some embodiments, the first conductive filaments have an insulating coating. In some embodiments, the filament bundle further includes an external (outer) coating mechanically coupling the first conductive filaments to the first reinforcing filaments along at least a portion of the length of the first conductive filaments. In some embodiments, the first conductive filaments comprise copper. In some embodiments, the first reinforcing filaments comprise stainless steel. In some embodiments, the first reinforcing filaments have a cross-sectional diameter larger than the cross-sectional diameter of the first conductive filaments. In some embodiments, the length of the first reinforcing filaments is shorter than the length of the first conductive filaments. In some embodiments, the filament bundle has a helical section and a non-helical section, and in the non-helical section, at least the first conductive filaments extend longitudinally along the length of the flexible elongate member toward at least one electrical connector (electrical contact), and the first conductive filaments are electrically connected via the electrical connector to a conductive ribbon embedded within the flexible elongate member.

[0009] One general aspect includes a method for assembling an intraluminal sensing guidewire, the method including the steps of providing a flexible elongate member configured to be placed within a body cavity of a patient, the flexible elongate member having a metal core wire extending along a longitudinal axis; attaching a sensing element to a distal portion of the flexible elongate member, the sensing element configured to acquire physiological data while the sensing element is placed within the body cavity; attaching an electrical connector to a proximal portion of the flexible elongate member; and assembling a filament bundle, the filament bundle coupling conductive filaments to reinforcing filaments, the conductive filaments having a first material strength and the reinforcing filaments having a second material strength greater than the first material strength. The method also includes helically wrapping the filament bundle around the metal core wire. The method also includes coupling at least the conductive filaments of the filament bundle to the sensing element and the electrical connector.

[0010]

[0010] Implementations may include one or more of the following features. In some embodiments, the conductive filaments comprise copper surrounded by an insulating coating. In some embodiments, the reinforcing filaments comprise stainless steel. In some embodiments, the reinforcing filaments have a cross-sectional diameter larger than a cross-sectional diameter of the conductive filaments. In some embodiments, the reinforcing filaments are shorter than the conductive filaments. In some embodiments, assembling the filament bundle comprises attaching the conductive filaments to the reinforcing filaments. Attaching the conductive filaments to the reinforcing filaments comprises attaching an insulating coating of the conductive filaments to the insulating coating of the reinforcing filaments. In some embodiments, attaching the conductive filaments to the reinforcing filaments comprises forming an insulating layer around the conductive filaments and the reinforcing filaments. In some embodiments, helically winding the filament bundle around the metal core wire comprises helically winding the filament bundle around a first section of the metal core wire, and the method further includes coupling the filament bundle to the flexible elongate member such that the filament bundle extends linearly along a different second section of the metal core wire.

[0011] One general aspect includes an intravascular flow sensing guidewire having a flexible elongate member configured for placement within a blood vessel, the flexible elongate member having a metal core wire extending along a longitudinal axis, a flow sensor disposed at a distal portion of the flexible elongate member and configured to sense a rate of blood flow within the blood vessel, and an electrical connector disposed at a proximal portion of the flexible elongate member. The intravascular flow sensing guidewire also includes a filament bundle disposed between the flow sensor and the electrical connector, the filament bundle including: a first conductive filament including a first material having a first material strength; a second conductive filament including the first material, the first conductive filament and the second conductive filament being in electrical communication with the flow sensor and the electrical connector; and a reinforcing filament including a second material having a different material strength greater than the first material strength; wherein the first conductive filament, the second conductive filament, and the reinforcing filament extend side by side in a helical manner around at least a portion of the length of the metal core wire.

[0012]

[0012] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of the features, details, utilities, and advantages of the reinforced multifilament conductor bundle defined in the claims is provided below in the description of various embodiments of the present disclosure and illustrated in the accompanying drawings.

[0013]

[0013] Exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a schematic side view of an intravascular sensing system including an intravascular device with a multifilamentary electrical conductor bundle according to an aspect of the present disclosure. [Figure 2]

[0015] FIG. 2 is a perspective view of an exemplary electronic component of an intravascular device according to an embodiment of the present disclosure. [Figure 3]

[0016] FIG. 3 is a perspective view of a multi-filament conductor bundle according to an embodiment of the present disclosure. [Figure 4]

[0017] FIG. 4 is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. [Figure 5]

[0018] FIG. 5 is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. [Figure 6]

[0019] FIG. 6 is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. [Figure 7]

[0020] FIG. 7 is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. [Figure 8]

[0021] FIG. 8 is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. [Figure 9]

[0022] FIG. 9 is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. [Figure 10]

[0023] FIG. 10 is a schematic side view of an intravascular device having a reinforced multifilamentary electrical conductor bundle in accordance with at least one embodiment of the present disclosure. [Figure 11]

[0024] FIG. 11 is a schematic side view of an intravascular device including a multifilamentary electrical conductor bundle in accordance with at least one embodiment of the present disclosure. [Figure 12]

[0025] FIG. 12 is a schematic diagram of a processor circuit in accordance with at least one embodiment of the present disclosure. [Figure 13]

[0026] FIG. 13 is a cross-sectional view of a multi-filament conductor bundle according to at least one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0015]

[0027] The reinforced (strengthened) multifilament conductor bundles of the present disclosure provide improved overall material strength of the filament assembly and reduce stretching and necking of fine-gauge filaments during the medical device manufacturing process. The fine-gauge wire can have dimensions of, for example, 40 to 54 American Wire Gauge (AWG), or a diameter of 0.0799 to 0.01575 millimeters. Improving the tensile strength of the multifilament conductor bundles can reduce manufacturing defects in miniature electronic devices, such as intravascular medical catheters and guidewire devices.

[0016]

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

[0017]

[0029] Aspects of the present disclosure may include one or more features described in U.S. Patent Application Publication Nos. 2014 / 0187874, 2015 / 0273187, 2015 / 0297138, 2016 / 0303354, 2016 / 0058977, and 2019 / 0059817, and U.S. Patent No. 9,770,225, each of which is incorporated by reference in its entirety as if fully set forth herein.

[0018]

[0030] Thus, the present disclosure provides a multifilamentary conductor bundle comprising pure copper or a high-conductivity copper alloy for the majority of the filaments in the bundle, and including either (a) one or more non-conductive reinforcing filaments with high tensile strength and high yield strength without changing the number of conductive filaments in the electrical conductor bundle, (b) conductive filaments formed from a high-strength material such as stainless steel, or (c) increasing the diameter of one of the filaments, with or without changing its composition. Any of these approaches will increase the overall strength of the multifilamentary bundle while maintaining desirable electrical properties for 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 different diameter from the other filaments in the bundle. For example, high-strength stainless steel may have a significantly lower electrical conductivity (e.g., 3-15% of that of pure copper). If not all of the filaments carry high current or high frequency signals (e.g., signal ground), it may be suitable to include one or more lower conductivity filaments along with relatively higher conductivity filaments.

[0019]

[0031] The multi-filament conductor bundle can be manufactured by a supplier based on part or material specifications. The reinforced multi-filament conductor bundle can advantageously improve the assembly workflow of intraluminal medical devices. Depending on the configuration, the reinforcing filaments can be used as signal-carrying conductors in an electrical circuit, as ground conductors, or as structural reinforcement that runs alongside other electrical filaments to a termination point but is not used for electrical connection.

[0020]

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

[0021]

[0033] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. Nevertheless, it will be understood that no limitation of the scope of the present disclosure is intended. Any changes and further modifications to the described devices, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one of ordinary skill in the art to which the present disclosure pertains, are fully contemplated and are intended to be included within the present disclosure. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. Furthermore, although the following description may refer to blood vessels, it will be understood that the present disclosure is not limited to such applications. For example, the devices, systems, and methods described herein may be used in any body cavity or lumen, including the esophagus, veins, arteries, intestines, ventricles, atria, or any other body cavity and / or cavities. However, for the sake of brevity, repeated descriptions of many of these combinations will not be provided.

[0022]

[0034] FIG. 1 is a schematic side view of an intravascular sensing system 100 according to an embodiment of the present disclosure, including an intravascular device 102 with a multifilamentary electrical conductor bundle 230. The intravascular device 102 may be an intravascular guidewire sized and shaped for placement within a patient's blood vessel. The intravascular device 102 includes a distal tip 108 and a sensing component 112. The sensing component 112 may be an electronic, electromechanical, mechanical, optical, and / or other suitable type of sensor. For example, the electronic component 112 may be a flow sensor configured to measure the velocity of blood flow within the patient's blood vessel, a pressure sensor configured to measure the pressure of blood flowing within the blood vessel, or other types of sensors, including, but not limited to, a temperature sensor or an imaging sensor. For example, flow data obtained by the flow sensor can be used to calculate physiological variables such as coronary flow reserve (CFR). Pressure data obtained by the pressure sensor can be used, for example, to calculate a physiological pressure ratio (e.g., FFR, iFR, Pd / Pa, or any other suitable pressure ratio). The imaging sensor may include an intravascular ultrasound (IVUS), intracardiac echocardiography (ICE), optical coherence tomography (OCT), or intravascular photoacoustic (IVPA) imaging sensor, for example, the imaging sensor includes one or more ultrasound transducer elements, including an array of ultrasound transducer elements.

[0023]

[0035] The intravascular device 102 includes a flexible elongate member 106. An electronic component 112 is disposed at a distal portion 107 of the flexible elongate 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 proximally from the housing 280 at the distal portion 107 of the flexible elongate member 106. A connecting portion 114 located at the proximal end of the flexible elongate 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 connecting portion 114 of the flexible elongate member 106. In some embodiments, the conductive portions 132, 134 are conductive metal rings disposed around the flexible elongate member. The locking portion is formed by a collar 118 and a knob 120 disposed on the proximal portion 109 of the flexible elongate member 106 .

[0024]

[0036] 1 includes a distal core wire 210 and a proximal core wire 220. The distal core 210 and the proximal core 220 are metal components that form part of the body of the intravascular device 102. For example, the distal core 210 and the proximal core 220 are flexible metal rods that provide structure for the flexible elongate member 106. The diameters of the distal core 210 and the proximal core 220 can vary along their lengths. The junction between the distal core 210 and the proximal core 220 is surrounded and contained by a hypotube 215.

[0025]

[0037] In some embodiments, the intravascular device 102 includes a distal (sub)assembly and a proximal (sub)assembly that are electrically and mechanically joined to provide electrical communication between the electronic component 112 and the conductive portions 132, 134. For example, flow data obtained by the electronic component 112 (in this example, the electronic component 112 is a flow sensor) is transmitted to the conductive portions 132, 134. Signals (e.g., operating voltage, start / stop commands, etc.) from a processing system 306 in communication with the intravascular device 102 are sent to the electronic component 112 via connectors 314 attached to the conductive portions 132, 134. The distal subassembly may include a distal core 210. The distal subassembly may include the electronic component 112, a multifilamentary conductor bundle 230, and / or one or more layers of insulating polymer / plastic 240 surrounding the conductive members 230 and core 210. For example, the polymer / plastic layer insulates and protects the conductive members of the multifilamentary 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 polymer layers 250) surrounding the proximal core 220 and / or conductive ribbons 260 embedded within the 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 of the intravascular device 102, the proximal and distal subassemblies may be electrically and mechanically coupled. As used herein, flexible elongate member may refer to one or more components along the length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220), and / or one or more components of the distal subassembly (e.g., including the distal core 210). The junction between the proximal core 220 and the distal core 210 is surrounded by a hypotube 215 .

[0026]

[0038] In various embodiments, intravascular device 102 includes one, two, three, or more core wires extending along its length. For example, in one embodiment, a single core wire extends along substantially the entire length of flexible elongate member 106. In such an embodiment, locking portion 118 and portion 120 may be integrally formed on a proximal portion of the single core wire. Electronic component 112 may be secured to a distal portion of the single core wire. In other embodiments, such as that shown in FIG. 1 , locking portion 118 and portion 120 may be integrally formed on a proximal portion of proximal core 220. Electronic component 112 may be secured to a distal portion of distal core 210. Intravascular device 102 includes one or more conductive members within multifilamentary conductor bundle 230 that communicate with electronic component 112. For example, conductor bundle 230 includes one or more electrical wires that communicate directly with electronic component 112. In some cases, the conductive member 230 is electrically and mechanically coupled to the electronic component 112, for example, by soldering. In some cases, the conductor bundle 230 has two or three electrical wires (e.g., a bifilar or trifilar cable). The individual electrical wires include bare metal conductors or metal conductors surrounded by one or more insulating layers. The multifilamentary conductor bundle 230 can extend along the length of the distal core 210. For example, at least a portion of the conductive member 230 is helically or spirally wrapped around the entire length of the distal core 210 or a portion of the length of the distal core 210.

[0027]

[0039] The intravascular device 102 includes one or more conductive ribbons 260 in a proximal portion of the flexible elongate member 106. The conductive ribbons 260 are embedded within the polymer layer 250. The conductive ribbons 260 are in direct communication with the conductive portions 132 and / or 134. In some cases, the multi-filament conductor bundle 230 is electrically and mechanically coupled to the electronic component 112, for example, by soldering. In some cases, the conductive portions 132 and / or 134 have a conductive ink (e.g., a metal nanoink, such as a silver or gold nanoink) deposited or printed directly on the conductive ribbons 260.

[0028]

[0040] As described herein, an electrical connection between the conductive member 230 and the conductive ribbon 260 may be established at the connection portion 114 of the flexible elongate member 106. By establishing an electrical connection between the conductor bundle 230 and the conductive ribbon 260, the conductive portions 132, 134 are electrically connected to the electronic component 112.

[0029]

[0041] 1, intravascular device 102 includes locking portion 118 and portion 120. To form locking portion 118, a machining process is required to remove polymer layer 250 and conductive ribbon 260 in locking portion 118 and to form proximal core 120 in locking portion 118. As shown in FIG. 1, locking portion 118 includes a reduced diameter, while portion 120 has a diameter substantially similar to that of proximal core 220 in connecting portion 114. In some cases, because the machining process removes the conductive ribbon in locking portion 118 and the end of conductive ribbon 260 will be exposed to moisture and / or liquids, such as blood, saline, disinfectant and / or enzymatic cleaner solutions, an insulating layer 158 is formed on the proximal end portion of connecting portion 114 to insulate the exposed conductive ribbon.

[0030]

[0042] In some embodiments, the connector 314 provides an electrical connection between the conductive portions 132, 134 and the patient interface module or monitor 304. The patient interface module (PIM) 304, in some cases, can be connected to a console or processing system 306, which includes or is in communication with a display 308. In some embodiments, the patient interface module 304 includes signal processing circuitry, such as an analog-to-digital converter (ADC), 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.

[0031]

[0043] The system 100 is deployed in a catheterization lab having a control room. The processing system 306 may be located in the control room. Optionally, the processing system 306 may be located elsewhere, such as in the catheterization lab itself. While the catheterization lab includes a sterile field, its associated control room may or may not be sterile depending on the procedure being performed and / or the medical facility. In some embodiments, the device 102 is controlled from a remote location, such as the control room, eliminating the need for an operator to be near the patient.

[0032]

[0044] The intraluminal device 102, PIM 304, and display 308 may be communicatively coupled directly or indirectly to the processing system 306. These elements may be communicatively coupled to the medical processing system 306 via a wired connection, such as a standard copper multifilament conductor bundle 230. The processing system 306 may 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 Optical Networking (SONET), may be utilized. In some cases, the processing system 306 may be communicatively coupled to a wide area network (WAN).

[0033]

[0045] The PIM 304 forwards the received signal to a processing system 306, where the information is processed and displayed on a 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 executes computer-readable instructions stored on a non-transitory, tangible, computer-readable medium.

[0034]

[0046] The PIM 304 facilitates signal communication between the processing system 306 and the intraluminal device 102. In some embodiments, the PIM 304 performs pre-processing of the data before relaying the data to the processing system 306. In an example of such an embodiment, the PIM 304 performs amplification, filtering, and / or aggregation of the data. In one embodiment, the PIM 304 provides high-voltage and low-voltage DC power via the multi-filament conductor bundle 230 to support operation of the intraluminal device 102.

[0035]

[0047] The multi-filament cable or transmission line bundle 230 includes multiple conductors, including one, two, three, four, five, six, seven, or more conductors. The multi-filament conductor bundle 230 may be disposed along the exterior of the distal core 210. The multi-filament conductor bundle 230 and the distal core 210 may be overcoated with an insulating and / or protective polymer 240. In the example shown in FIG. 1 , the multi-filament conductor bundle 230 includes two straight portions 232 and 236 where the multi-filament conductor bundle 230 extends linearly and parallel to the longitudinal axis of the flexible elongate member 106 on the exterior of the distal core 210, and a helical or spiral portion 234 where the multi-filament conductor bundle 230 is wrapped around the exterior of the distal core 210. In some embodiments, the multi-filament conductor bundle 230 includes only straight portions or only helical or spiral portions. In general, the multi-filament conductor bundle 230 can extend in a linear, wound, non-linear, or unwound manner, or any combination thereof. Communication (if any) along the multi-filament conductor bundle 230 can be by a number of methods or protocols, including serial, parallel, and others, where one or more filaments of the bundle 230 carry signals. One or more filaments of the multi-filament conductor bundle 230 can also transmit direct current (DC) power, alternating current (AC) power, or function as an electrical ground connection.

[0036]

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

[0037]

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

[0038]

[0050] 2 is a side view of an exemplary electronic component 112 of an intravascular device 102 according to an aspect of the present disclosure. For example, the electronic component 112 can be a pressure sensor, a flow sensor, a temperature sensor, or other sensor configured to measure parameters of blood flow within a patient's blood vessel. 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 an anatomical structure (e.g., a flowing fluid such as blood). The transducer element generates an electrical signal representative of the echo. The signal-carrying filament transmits the electrical signal from the sensor at the distal portion to a connector at the proximal portion. The processing system processes the electrical signal to extract the fluid flow rate. In other embodiments, the instrument 102 may be used to examine any number of anatomical locations and tissue types, including, without limitation, organs including the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures including the brain, thecal sac, spinal cord, and peripheral nerves; the urinary tract; and valves, ventricles, or other portions of the heart's blood vessels and / or other systems of the body. In addition to natural structures, the instrument 102 may also be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices. In some embodiments, the electronics 112 may include imaging components (e.g., intravascular ultrasound imaging components), measurement components (e.g., pressure, flow, or temperature sensors), and / or therapeutic components (e.g., ablation components). In some embodiments, the electronics 112 may be fully or partially enclosed within the housing 280. In some embodiments, the electronics may be disposed at or near the distal end of the flexible elongate member and may include a distal tip 108 (e.g., an atraumatic tip). In some embodiments, one or more electronic components are disposed at a distal portion of the flexible elongate member. For example, the one or more electronic components can be disposed at the distal tip (at the leading edge of the flexible elongate member and / or where the distal portion terminates) or can be spaced proximally 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 distances greater or less).Some embodiments of the intraluminal device 102 include multiple different electronic components (e.g., pressure and flow sensors, or any other number or combination of sensors). In such embodiments, a first electronic component is located at the distal tip of the flexible elongate member, and a second electronic component is spaced apart from the distal tip and / or the first electronic component (e.g., by 0.5 cm, 1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, and / or other suitable greater or lesser value). In some embodiments, power, control signals, and electrical ground or signal return are provided by a multifilamentary conductor bundle 230, shown in the example of FIG. 2 as bifilar having two conductive filaments 310 and 330. The conductive filaments 310 and 330 may be formed, for example, from pure copper or a copper alloy such as BeCu or AgCu.

[0039]

[0051] FIG. 3 is a perspective view of a multifilamentary conductor bundle 230 according to an embodiment of the present disclosure. In the example shown in FIG. 3, the multifilamentary conductor bundle 230 is a trifilar including three conductors 310, 320, and 330, each surrounded by an insulating sheath 315, 325, and 335. These insulating sheaths may be formed, for example, from polyimide. An additional overcoating 340 may be applied, for example, by dip coating, although other methods may alternatively or additionally be used. In a conventional trifilar, all three conductors are of the same or similar diameter and may be formed from pure copper or a copper alloy such as BeCu. While the multifilamentary conductor bundle 230 is shown here with the conductors arranged side-by-side in a planar configuration, those skilled in the art will recognize that other arrangements may alternatively or additionally be used.

[0040]

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

[0041]

[0053] FIG. 4 is a cross-sectional view of a multifilamentary conductor bundle 230 in accordance with at least one embodiment of the present disclosure. In the example shown in FIG. 4, the multifilamentary conductor bundle 230 is a trifilar including two conductive filaments 310 and 330, each surrounded by an insulating sheath 315 and 335. In the example shown in FIG. 4, the central filament of the bundle 230 is a reinforcing filament 420, which may be formed, for example, from a material having a higher tensile strength and / or a higher yield strength (e.g., stainless steel) than the conductive material (e.g., copper or BeCu) of the 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 multi-filament conductor bundle 230 may or may not include an additional overcoating 340, such as nylon or polyurethane, that bonds the separate insulators 315, 425, and 335 together so that the filaments 310, 420, and 330 form a single, combined conductor bundle 230. In some embodiments, the conductive filaments 310 and 330, but not the reinforcing filaments, are surrounded by the insulating sheaths 315, 335, and the multi-filament conductor bundle 230 is covered by the overcoating 340.

[0042]

[0054] The addition of reinforcing filaments 420 with high tensile strength or high yield strength increases the overall tensile strength of multifilamentary thin wire bundle 230 while maintaining the desirable electrical properties of conductive filaments 310 and 330. This configuration may allow pure copper to be used for conductive filaments 310 and 330 instead of copper alloys such as BeCu or AgCu, for example, without compromising the mechanical strength of multifilamentary conductor bundle 230 and while significantly reducing the risk of stretching and necking that could break the filaments or limit their current carrying capacity.

[0043]

[0055] In some embodiments, the reinforcing filaments 420 are not connected to electrical terminals at one or both ends of the multifilament conductor bundle. High-strength stainless steel can have significantly lower electrical conductivity (e.g., 3-15% of that of pure copper), making it less desirable for use as an electrical conductor. However, in other cases, the reinforcing filaments 420 can be used as conductors for specific applications. For example, for filaments that do not need to carry large currents or high-frequency signals (such as signal and ground wires), the low electrical conductivity of the reinforcing material (e.g., stainless steel) may be acceptable.

[0044]

[0056] Other materials, whether conductive or not, can be used in place of or in addition to stainless steel. In the example shown in FIG. 4, the multifilament conductor bundle 230 is shown with three filaments arranged side-by-side in a planar configuration. However, other configurations and numbers of filaments, whether conductive or reinforcing, can be used instead or in addition. Furthermore, while the filaments are shown as circular in cross section, some or all of the filaments may be oval, rectangular, or curved in cross section to minimize the profile of the multifilament conductor bundle relative to a guidewire, catheter, or other device.

[0045]

[0057] In some embodiments, insulating sheath 315, 335, 425 may be omitted. In such embodiments, overcoating 340 provides electrical insulation between conductive threads 310, conductive threads 330, and / or reinforcing threads 420.

[0046]

[0058] FIG. 5 is a cross-sectional view of a multifilamentary conductor bundle 230 in accordance with at least one embodiment of the present disclosure. In the example shown in FIG. 5, the multifilamentary conductor bundle 230 is a trifilar including two conductive filaments 310 and 330, each surrounded by an insulating sheath 315 and 335. In the example shown in FIG. 5, the left outer filament of the bundle 230 is a reinforcing filament 420, which may or may not include an insulating sheath 425. The reinforcing filament 420 may be positioned in any suitable location (e.g., left side, right side, outer, central, etc.). The multifilamentary conductor bundle 230 may or may not include an additional overcoating 340 that bonds the filaments to form a single conductor bundle 230. In the example shown in FIG. 5, the multifilamentary conductor bundle 230 is shown with three filaments arranged side-by-side in a planar configuration. However, other arrangements and other numbers of filaments, whether conductive or reinforcing, may alternatively or additionally be used.

[0047]

[0059] FIG. 6 is a cross-sectional view of a multifilamentary conductor bundle 230 in accordance with at least one embodiment of the present disclosure. In the example shown in FIG. 6, the multifilamentary conductor bundle 230 is a trifilar including two conductive filaments 310 and 330, each surrounded by an insulating sheath 315 and 335. In the example shown in FIG. 6, the central filament of the bundle 230 is a reinforcing filament 420, which may or may not include an insulating sheath 425. In this example, the multifilamentary conductor bundle 230 does not include an additional overcoating 340 that binds the filaments together. However, the filaments 310, 330, and 420 may be fastened, braided, or otherwise bound to one another, or may simply be routed in parallel but in a separate manner, in which case the reinforcing filament 420 helps prevent the conductive filaments 310 and 330 from stretching or necking during tensioning of the filaments. 6, the multifilamentary conductor bundle 230 is shown with three filaments arranged side-by-side in a planar configuration, however, other configurations and other numbers of filaments, either conductive or reinforcing, may alternatively or additionally be used.

[0048]

[0060] FIG. 7 is a cross-sectional view of a multifilamentary conductor bundle 230 in accordance with at least one embodiment of the present disclosure. In the example shown in FIG. 7, the multifilamentary conductor bundle 230 is a trifilar including two conductive filaments 310 and 330, each surrounded by an insulating sheath 315 and 335. In the example shown in FIG. 7, the left outer filament of the bundle 230 is a reinforcing filament 420, which may or may not include an insulating sheath 425. In this example, the multifilamentary conductor bundle 230 does not include an additional overcoating 340 that bonds the filaments together. However, the filaments 310, 330, and 420 may be otherwise bonded to one another or routed in parallel but separate fashion, in which case the reinforcing filament 420 helps prevent the conductive filaments 310 and 330 from stretching or necking. In the example shown in FIG. 7, the multifilamentary conductor bundle 230 is shown with three filaments arranged side-by-side in a planar configuration. However, other arrangements and numbers of threads, whether conductive or reinforcing, may be used instead or in addition.

[0049]

[0061] FIG. 8 is a cross-sectional view of a multi-filament conductor bundle 230 in accordance with at least one embodiment of the present disclosure. In the example shown in FIG. 8, the multi-filament conductor bundle 230 is a trifilar including two conductive filaments 310 and 330, each surrounded by an insulating sheath 315 and 335. In the example shown in FIG. 8, one filament in the bundle 230 is a reinforcing filament 420, which may or may not include an insulating sheath 425. The multi-filament conductor bundle 230 may or may not include an additional overcoating 340 to bond the filaments together to form a single, bonded conductor bundle 230. In the example shown in FIG. 8, the multi-filament conductor bundle 230 is shown with three filaments arranged in a triangular configuration. However, other arrangements and other numbers of filaments, whether conductive or reinforcing, may be used instead or in addition. While a flat (side-by-side) arrangement of the conductors minimizes the profile of the conductor bundle relative to the catheter, guidewire, or other device, a stacked (e.g., triangular, rectangular, etc.) arrangement may be advantageous or desirable for other reasons, depending on the implementation.

[0050]

[0062] FIG. 9 is a cross-sectional view of a multifilamentary conductor bundle 230 in accordance with at least one embodiment of the present disclosure. In the example shown in FIG. 9, the multifilamentary conductor bundle 230 is a trifilar including two conductive filaments 310 and 330, each surrounded by an insulating sheath 315 and 335. In the example shown in FIG. 9, the central filament of the bundle 230 is a reinforcing filament 420 having a larger diameter than the conductive filaments 310 and 330. In the illustrated embodiment, the reinforcing filament 420 comprises a different material with relatively higher strength than the material used for the conductive filaments 310 and 330 and is surrounded by an insulating sheath 425. In other embodiments, the reinforcing filament 420 is formed from the same material as the conductive filaments 310 and 330. In some embodiments, the reinforcing filament 420 does not include an insulating sheath 425. The multi-filament conductor bundle 230 may or may not include an additional overcoating 340 that bonds the filaments together to form a single conductor bundle 230 .

[0051]

[0063] The tensile strength or yield strength of a filament may depend on its composition. The total force required to stretch, neck, or otherwise deform a filament may depend on the diameter of the filament. Thus, the addition of reinforcing filaments 420 having a diameter larger than that of conductive filaments 310 and 330 may increase the total force required to stretch or neck the conductive filaments of multifilamentary wire bundle 230 relative to multifilamentary wire bundle 230. In the example shown in FIG. 9, multifilamentary conductor bundle 230 is shown with three filaments arranged in a planar, side-by-side configuration. However, other configurations and numbers of filaments, whether conductive or reinforcing, may be used instead or in addition. While a planar (side-by-side) arrangement of conductors of the same size minimizes the profile of the conductor bundle relative to a catheter or guidewire, having one or more conductors with a larger diameter may be advantageous or desirable for other reasons, depending on the implementation.

[0052]

[0064] 10 is a side view of an intravascular device 102 with a reinforced (reinforced) multifilamentary electrical conductor bundle 230, in accordance with at least one embodiment of the present disclosure. Shown are proximal core wire 220 and distal core wire 210 joined by hypotube 215. At the distal end of the distal core wire is coil 290, which terminates in electronic device 112, which may be fully or partially enclosed within housing 280. Also visible is reinforced multifilamentary conductor bundle 230, which includes conductive filaments 310 and 330 and reinforcing filaments 420.

[0053]

[0065] Conductive filaments 310 and 330 connect the electronic component 112 to electrical contacts 1010 formed on conductive ribbon 260, which are in electrical contact with conductive regions 132 and 134. The reinforced multi-filament conductor bundle 230 includes a straight region 232 that passes through coil 290. The reinforced multi-filament conductor bundle 230 also includes a helical region 234 that encases distal core wire 210 and is overcoated with an insulating or protective polymer coating 240. In the helical region, the bundle's filaments 310, 330, 420 extend parallel around distal core wire 210 such that the helical shape formed by the filaments 310, 330, 420 is concentric with the distal core wire 210. The filaments 310, 330, 420 are shown extending in contact with one another. In this regard, the threads 310, 330, 420 may be attached to one another or may be unattached to one another such that the threads 310, 330, 420 extend adjacent one another. The reinforced multi-filament conductor bundle 230 further includes straight sections 236 that extend through the hypotube 215. Between the hypotube 215 and the electrical contacts 1010, the conductive threads are overcoated with a polymer coating 250. In some embodiments, the electrical contacts 1010 are formed by removing (e.g., etching, ablation) a portion of the outer insulating coating or layer covering the ribbon 260 and soldering the conductive threads 310, 330 to the ribbon 260.

[0054]

[0066] 10 , reinforcing filaments 420 are present within the multifilamentary conductor bundle 230 in the helical region 234 but are absent from the straight regions 232 and 236. The distal ends of the reinforcing filaments 420 terminate at location 1020, which is proximal to the distal end of the distal core wire 210. Location 1020 may be aligned, for example, with the location where the tapering begins in the distal portion of the distal core wire 210. The proximal ends of the reinforcing filaments 420 terminate at location 1030, which is distal to the proximal end of the distal core wire 210. Location 1030 may be aligned, for example, with the location where the tapering begins in the proximal portion of the distal core wire 210. The reinforcing filaments may be cut, trimmed, or bent at locations 1020 and 1030, for example, to separate them from conductive filaments 310 and 330 at these locations, providing strength to multifilament conductor bundle 230 in challenging areas such as helical region 234, but without interfering with delicate assembly processes at the electrically terminated ends and without adding undesirable stiffness to coil 290. The multifilament conductor bundle 230 may also be easier to power through certain couplings in which reinforcing filaments 420 have been removed.

[0055]

[0067] 11 is a schematic side view of an intravascular device 102 with a multi-filament electrical conductor bundle 230, in accordance with at least one embodiment of the present disclosure. Shown are proximal core wire 220 and distal core wire 210 joined by hypotube 215. At the distal end of the distal core wire is coil 290, which terminates in electronic device 112, which is fully or partially enclosed within housing 280. Also shown is reinforced multi-filament conductor bundle 230, which includes conductive filaments 310 and 330 and reinforcing filaments 420.

[0056]

[0068] Conductive filaments 310 and 330 connect electronic component 112 to electrical contacts 1010 formed on conductive ribbon 260, which are in electrical contact with conductive regions 132 and 134. The reinforced multi-filament conductor bundle 230 also includes a straight region 232 that passes through coil 290. The reinforced multi-filament conductor bundle 230 also includes a helical region 234 that wraps around distal core wire 210 and is overcoated with polymer coating 240. The reinforced multi-filament conductor bundle 230 further includes a straight region 236 that passes through hypotube 215. Between hypotube 215 and electrical contacts 1010, the conductive filaments are overcoated with polymer coating 250.

[0057]

[0069] 11, reinforcement filaments 420 are present in helical region 234 and also in straight regions 232 and 236, but are not electrically terminated at either end. In other embodiments, reinforcement filaments 420 may be used as conductors and may be electrically terminated, for example, at an electronic device on the distal end and at electrical connection 1010 at the proximal end.

[0058]

[0070] 12 is a schematic diagram of a processor circuit 1250 in accordance with at least one embodiment of the present disclosure. Processor circuit 1250 may be implemented within intravascular sensing system 100 or another device or workstation (e.g., a third-party workstation, a network router, etc.), or in a cloud processor or other remote processing unit, as needed to perform the methods. As shown, processor circuit 1250 may include a processor 1260, a memory 1264, and a communication module 1268. These elements may communicate with each other directly or indirectly, for example, via one or more buses.

[0059]

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

[0060]

[0072] Memory 1264 may include cache memory (e.g., 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 a combination of different types of memory. In one embodiment, memory 1264 includes a non-transitory computer-readable medium. Memory 1264 stores instructions 1266. Instructions 1266 may include instructions that, when executed by processor 1260, cause processor 1260 to perform the processes described herein. Instructions 1266 may also be referred to as code. The terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement. For example, the terms “instructions” and “code” may refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" may include a single computer-readable statement or multiple computer-readable statements.

[0061]

[0073] The communications module 1268 may include any electronic and / or logic circuitry that facilitates the direct or indirect communication of data between the processor circuit 1250 and other processors or devices. In that regard, the communications module 1268 may be an input / output (I / O) device. In some instances, the communications module 1268 facilitates direct or indirect communication between the processor circuit 1250 and / or various elements of the intravascular measurement system 100. The communications module 1268 communicates within the processor circuit 1250 via a number of methods or protocols. Serial communications protocols include, but are not limited to, US SPI, I2C, and the like. 2 C, RS-232, RS-485, CAN, Ethernet, ARINC429, MODBUS, MIL-STD-1553, or other suitable methods or protocols. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Serial and parallel communications can be bridged, if desired, by UART, USART, or other suitable subsystems.

[0062]

[0074] External communication (including, but not limited to, software updates, firmware updates, sharing presets between the processor and a central server, or reading from the ultrasound device) can be achieved using any suitable wireless or wired communication technology, such as USB, micro USB, Lightning, FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or a cellular data connection such as 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G. For example, a Bluetooth Low Energy (BLE) radio can be used to establish a connection with a cloud service for transmitting data and receiving software patches. The controller is configured to communicate with a remote server or a local device such as a laptop, tablet, or handheld device, and may include a display capable of displaying status variables and other information. Information is transmitted on physical media such as a USB flash drive or memory stick.

[0063]

[0075] Figure 13 is a cross-sectional view of a multifilamentary conductor bundle 230 in accordance with at least one embodiment of the present disclosure. In the example shown in Figure 13, the multifilamentary conductor bundle 230 is a quadruple filer including two conductive filaments 310 and 330, each surrounded by an insulating sheath 315 and 335. In the example shown in Figure 13, the two central filaments of the bundle 230 are reinforcing filaments 420, each of which may or may not include an insulating sheath 425. The multifilamentary conductor bundle 230 may or may not include an additional overcoating 340 that bonds the filaments together to form a single conductor bundle 230.

[0064]

[0076] It can thus be seen that the reinforced multifilament conductor bundle advantageously increases the strength of multifilament conductor bundles that may be used in the manufacture of miniature electronic devices such as intravascular medical catheters and guidewires. Many variations on the examples and embodiments described above are possible. For example, a multifilament conductor bundle may include multiple reinforcing filaments of the same or different types, or all of the filaments in a multifilament conductor bundle or cable may be reinforced filaments.

[0065]

[0077] The logical operations making up the embodiments of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. It should be understood that these may be arranged or performed in any order unless expressly indicated otherwise or unless a particular order is inherently required by claim language. It should also be understood that the described technology may be used in medical or non-medical single-use and multi-use electrical and electronic devices.

[0066]

[0078] All directional references, such as top, bottom, inside, outside, upward, downward, left, right, lateral, front, rear, top, bottom, superior, lower, vertical, horizontal, clockwise, counterclockwise, proximal, and distal, are used for identification purposes only to aid the reader's understanding of the claimed subject matter and do not constitute limitations on the location, orientation, or use of the particular reinforced multifilament conductor bundle. References to connections, such as attached, coupled, connected, and coupled, should be interpreted broadly and may include intermediate members between and relative movement between elements, unless otherwise indicated. Thus, a reference to connections does not necessarily imply that two elements are directly connected and in a fixed relationship to one another. The term "or" should be interpreted to mean "and / or" rather than "exclusively or." The word "comprising" does not exclude other elements or steps, and the singular does not exclude a plurality. Unless expressly stated otherwise in the claims, listed values ​​should be interpreted as examples only, and not as limitations.

[0067]

[0079] The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the reinforced multifilament conductor bundles defined in the claims. While various embodiments of the claimed subject matter have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art may make numerous modifications to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter.

[0068]

[0080] Still other embodiments are contemplated. All matter contained in the above description and shown in the accompanying drawings is to be interpreted as merely illustrative of particular embodiments and is not intended to be limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter defined in the claims.

Claims

1. a flexible elongate member for placement within a body cavity of a patient, the flexible elongate member having a metal core wire extending along a longitudinal axis; a sensing element disposed on a distal portion of the flexible elongate member for acquiring physiological data while disposed within a body cavity; an electrical connector disposed on a proximal portion of the flexible elongate member; and an intraluminal sensing guidewire having a filament bundle disposed between the sensing element and the electrical connector, The filament bundles are a first conductive filament having a first tensile strength and / or yield strength, the first conductive filament in electrical communication with the sensing element and the electrical connector; and a first reinforcing filament having a second tensile strength and / or yield strength greater than the first tensile strength and / or yield strength; the filament bundle has a helical section and a non-helical section; the first reinforcing filaments are disposed only in the helical section; Intraluminal sensing guidewire.

2. The endoluminal sensing guidewire of claim 1 , wherein the first conductive filaments and the first reinforcing filaments extend side by side in a helical manner around the metallic core wire.

3. 10. The endoluminal sensing guidewire of claim 1, wherein the filament bundle further comprises a second conductive filament having the first tensile strength and / or yield strength, the second conductive filament being in electrical communication with the sensing element and the electrical connector.

4. The endoluminal sensing guidewire of claim 1 , wherein the filament bundle further comprises second reinforcing filaments having the second tensile strength and / or yield strength.

5. The endoluminal sensing guidewire of claim 1 , wherein the first reinforcing filaments and / or the first conductive filaments have an insulating coating.

6. 4. The endoluminal sensing guidewire of claim 3, wherein the sensing element is a flow sensor, and the first conductive filaments, the second conductive filaments, and the first reinforcing filaments extend side by side in a helical manner around at least a portion of the length of the metallic core wire.

7. 10. The endoluminal sensing guidewire of claim 1, wherein the filament bundle further comprises an outer coating that mechanically couples the first conductive filaments to the first reinforcing filaments along at least a portion of the length of the first conductive filaments and the first reinforcing filaments.

8. The endoluminal sensing guidewire of claim 1 , wherein the first conductive filaments comprise copper and / or the first reinforcing filaments comprise stainless steel.

9. The endoluminal sensing guidewire of claim 1 , wherein the first reinforcing filaments have a cross-sectional diameter greater than a cross-sectional diameter of the first conductive filaments.

10. The endoluminal sensing guidewire of claim 1 , wherein the length of the first reinforcing filaments is less than the length of the first conductive filaments.

11. An intraluminal sensing guidewire as described in claim 1, wherein in the non-helical section, the first conductive filament extends longitudinally along the length of the flexible elongated member toward at least one electrical connector, and the first conductive filament is electrically connected to a conductive ribbon embedded within the flexible elongated member via the electrical connector.

12. 1. A method of assembling an endoluminal sensing guidewire, the method comprising: providing a flexible elongate member disposed within a body cavity of a patient, the flexible elongate member having a metal core wire extending along a longitudinal axis; attaching a sensing element to a distal portion of the flexible elongate member for acquiring physiological data while positioned within a body cavity; attaching an electrical connector to a proximal portion of the flexible elongate member; assembling a thread bundle, the assembling comprising bonding conductive threads to reinforcing threads, the conductive threads having a first tensile strength and / or yield strength, and the reinforcing threads having a second tensile strength and / or yield strength greater than the first tensile strength and / or yield strength; helically wrapping the filament bundle around the metal core wire; and coupling at least the conductive filaments of the filament bundle to the sensing element and the electrical connector; the filament bundle has a helical section and a non-helical section; The reinforcing filaments are disposed only in the helical section. method.

13. The method of claim 12 , wherein assembling the thread bundle comprises attaching the conductive threads to the reinforcing threads.

14. 14. The method of claim 13, wherein the step of attaching the conductive threads to the reinforcing threads comprises either attaching an insulating coating of the conductive threads to an insulating coating of the reinforcing threads, or forming an insulating layer around the conductive threads and the reinforcing threads.

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