Intratubular physiological sensing device with implantable conformal conductor

Abstract

To improve the electrical and mechanical performance of intraluminal physiological sensing devices. [Solution] The intraluminal sensing device comprises a guidewire configured to be placed in a lumen of a patient's body. The guidewire comprises a core wire 220, a first insulating coating 850 covering at least a portion of the core wire, and at least two conductive traces 660 insulated from each other and extending longitudinally along at least a portion of the total length of the core wire, covering the outer surface of the first insulating coating. Each conductive trace conforms to the curvature of the first insulating coating. The guidewire also comprises a second insulating coating 1050 covering the conductive traces along at least a portion of the total length of the core wire, and a sensor configured to electrically communicate with the at least two conductive traces and to be placed in a lumen of the body to obtain physiological data. The guidewire also comprises a proximal connector that electrically communicates with the conductive traces.

Description

Technical Field

[0001]

[0001] The subject matter described herein relates to intravascular physiological sensing devices. For example, an intravascular catheter or guide wire may include an implanted conformal metal conductor, and associated systems and methods.

Background Art

[0002]

[0002] Intravascular physiological sensing devices are introduced into the lumen of a patient's body and, for example, include a physiological sensor at the tip of a catheter or guide wire. Wires are used to connect the sensing element at the tip of the catheter or guide wire to a connector at the proximal end of the catheter or guide wire. The thin wires are called filaments. Small-diameter medical devices such as intravascular (e.g., intracoronary) catheters and guide wires incorporate sensors (e.g., pressure, temperature, flow, or image sensors), and their output and communication are carried out through a multifilament (e.g., bifilament, trifilament, etc.) conductor bundle or a flat metal ribbon. In both cases, reducing the size of the device poses difficulties in the manufacturing process of the device regarding conductor wiring, winding, and fixation.

Summary of the Invention

Problems to be Solved by the Invention

[0003]

[0003] Guidewires and catheters are typically constructed of thin filers and / or flat ribbon wires that enable the transmission of electrical signals between electrical components within the device, such as sensors, transducers, and contacts. To make these connections, the filers and / or flat ribbon wires are embedded in a polymer along the entire length of the device via a winding or pulling process in a continuous reel-to-reel coating apparatus. Bundles of electrical filers are joined as two, three, or more thin conductive filers to make electrical connections between electrical components, such as between sensors or transducers near the tip of the device and electrical contacts near the proximal end of the device. To make these connections, the filers or ribbons are wound or pulled along the entire length of the device from one end to the other. The mechanical strength of conductive materials is typically low because copper and many copper alloys have low tensile and yield strengths. The manufacturing process of intraluminal catheters or guidewire devices involves winding or stretching ribbons or multifilament conductor bundles, which require the application of tension. Unfortunately, the application of this tension can cause plastic deformation of the conductive filer or ribbon, resulting in serious undesirable elongation and / or constriction, for example, elongation of up to 100% in some current processes. The associated constriction of the conductor affects both the mechanical strength and maximum current capacity of the filer, which can lead to manufacturing defects.

[0004]

[0004] Some currently used devices utilize flat conductive metal ribbons that have a wider width and lower height, and may have a current-tolerant capacity comparable to that of filers, which may allow for smaller diameter devices. These conductive ribbons can, in some cases, withstand tensioning better, but do not conform to the cylindrical shape of the core wire, and therefore require a thicker insulating layer to avoid conductor exposure at the edges of the ribbon. These ribbons often need to be manufactured separately and added to the device. However, arranging and maintaining them in a linear fashion is difficult.

[0005]

[0005] The information contained in this Technical Background section of this Specification, including any references and descriptions or discussions thereof cited herein, is provided for technical reference purposes only and should not be considered subject matter restricting the scope of this Disclosure. [Means for solving the problem]

[0006]

[0006] An intubular physiological sensing device comprising a metal ink conductor assembly is disclosed. In some embodiments, the metal ink conductor assembly may provide a single or multi-layer coating of conductive metal ink traces, enabling improved electrical / mechanical performance and mitigating or eliminating manufacturing challenges associated with conductive filers or ribbons. The use of nanometal ink traces allows for the use of conductive materials having lower tensile strength and larger conductor cross-section or surface area. This results in lower electrical resistance / impedance along the entire length of the electromechanical device, as well as improved straightness and torque responsiveness of the intubular device, reducing manufacturing defects and decreasing the complexity of the manufacturing process for the intubular device.

[0007]

[0007] The nanometal ink is applied as a direct liquid coating to the insulating polymer surrounding the core wire. Each layer of ink can then be sintered, thereby making the coating a solid metal with material properties equivalent to those of a bulk material. After sintering, an additional insulating layer is coated to a desired thickness. Once the desired thickness is achieved, one or more nanometal layers can then be individualized to create traces with a desired cross-sectional area.

[0008]

[0008] The metal ink conductor assemblies disclosed herein are particularly useful with respect to intraluminal medical catheters and guidewires, but do not exclude others.

[0009]

[0009] One general embodiment includes an intraluminal sensing device. The intraluminal sensing device is a guidewire configured to be placed in a lumen of a patient's body, the guidewire comprising: a core wire; a first insulating coating covering at least a portion of the periphery of the core wire along at least a portion of the total length of the core wire; at least two conductive traces each having a certain thickness and a certain width, covering the outer surface of the first insulating coating and extending longitudinally along at least a portion of the total length of the core wire, each conductive trace having a cross-sectional shape conforming to the curvature of the first insulating coating, and insulating at least two conductive traces and the core wire from each other; a second insulating coating covering the outer surface of at least two conductive traces along at least a portion of the total length of the core wire; a sensor located at the tip of the guidewire and electrically in contact with at least two conductive traces, configured to be placed in a lumen of the body and to obtain physiological data; and a connector located at the proximal end of the guidewire and electrically in contact with at least two conductive traces.

[0010]

[0010] In some embodiments, the in-tube sensing device further comprises a third insulating coating that covers the upper surface of the second insulating coating along at least a portion of the entire length of the core wire, enclosing the entire circumference of the core wire. In some embodiments, the third insulating coating covers at least one portion of the conductive trace, the first insulating coating, or the core wire. In some embodiments, at least two conductive traces include three conductive traces. In some embodiments, the conductive trace includes conductive ink. In some embodiments, the conductive ink is colloidal. In some embodiments, the conductive ink is sintered. In some embodiments, the conductive ink includes at least one particle of gold, copper, silver, or aluminum. In some embodiments, at least two of the first insulating coating, the second insulating coating, or the third insulating coating include the same insulating material. In some embodiments, at least two of the first insulating coating, the second insulating coating, and the third insulating coating include different insulating materials. In some embodiments, each conductive trace has a cross-sectional shape that conforms to the curvature of the first insulating coating, and at least two conductive traces, at least two additional conductive traces, and the core wire are all insulated from each other.

[0011]

[0011] One common embodiment includes an intraluminal sensing system. The system comprises an intraluminal sensing guidewire and a processor circuit in communication with the intraluminal sensing guidewire. The processor circuit is configured to receive physiological data obtained by the sensor, process the physiological data, and output a graphical representation of the physiological data to a display in communication with a processing system. In some embodiments, the system further comprises a patient interface module (PIM). Implementations include hardware, methods or processes, or computer software on a computer-accessible medium.

[0012]

[0012] One general embodiment includes a method for manufacturing an in-tube sensing guidewire. The method comprises the steps of: providing a core wire; coating the entire circumference of the core wire along at least a portion of its total length with a first insulating material; coating the entire circumference of the core wire along at least a portion of its total length with a conductive ink, covering the first insulating material; coating the entire circumference of the core wire along at least a portion of its total length with a second insulating material, covering the conductive ink; removing material from at least the second insulating material and at least two surrounding arcs of the conductive ink so that the conductive ink forms at least two longitudinal conductive traces along at least a portion of the core wire and the at least two longitudinal conductive traces are electrically isolated from each other and from the core wire; and coating the entire circumference of the core wire along at least a portion of its total length with a third insulating material, covering the second insulating material and the two surrounding arcs.

[0013]

[0013] In some embodiments, at least two longitudinal conductive traces include three conductive traces. In some embodiments, the method further comprises the step of sintering a conductive ink. In some embodiments, the conductive ink includes particles of gold, copper, silver, or aluminum. In some embodiments, at least two of the first insulating material, the second insulating material, or the third insulating material include the same insulating material. In some embodiments, at least two of the first insulating material, the second insulating material, and the third insulating material include different insulating materials.

[0014]

[0014] One general embodiment is a guidewire configured to be positioned with a patient's blood vessel, the guidewire comprising a core wire, a first insulating coating covering at least a portion of the periphery of the core wire along at least a portion of the total length of the core wire, and at least two conductive traces comprising sintered metal ink, each conductive trace having a certain thickness and a certain width, covering the outer surface of the first insulating coating and extending longitudinally along at least a portion of the total length of the core wire, each conductive trace having a cross-sectional shape that conforms to the curvature of the first insulating coating, and at least two conductive traces and the core wire being insulated from each other, and the core wire The intravascular sensing device includes a guidewire comprising: a second insulating coating covering the outer surfaces of at least two conductive traces along at least a portion of its total length; a third insulating coating covering the upper surface of the second insulating coating along at least a portion of the total length of the core wire, surrounding the entire circumference of the core wire and covering at least one portion of the conductive traces, the first insulating coating, or the core wire; at least one of a pressure sensor or a flow sensor positioned at the tip of the guidewire and electrically communicating with at least two conductive traces; and a connector positioned at the proximal end of the guidewire and electrically communicating with at least two conductive traces.

[0015]

[0015] This summary of the invention is provided to introduce conceptual selections in simplified forms, which are further described below in embodiments for carrying out the invention. This summary is not intended to identify basic 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, usefulness and advantages of the metal ink conductor assembly as defined in the claims is provided in the following written description of various embodiments of the disclosure and illustrated in the accompanying drawings.

[0016]

[0016] Exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings. [Brief explanation of the drawing]

[0017] [Figure 1]

[0017] Side view of an intravascular sensing system comprising an intravascular device comprising a conductive member and a conductive ribbon, according to an aspect of the present disclosure. [Figure 2]

[0018] Side view of another type of intravascular device, according to an aspect of the present disclosure. [Figure 3]

[0019] Perspective view of a multifilar conductor bundle, according to an aspect of the present disclosure. [Figure 4]

[0020] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to an aspect of the present disclosure. [Figure 5]

[0021] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to an aspect of the present disclosure. [Figure 6]

[0022] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to at least one embodiment of the present disclosure. [Figure 7]

[0023] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to at least one embodiment of the present disclosure. [Figure 8]

[0024] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to at least one embodiment of the present disclosure. [Figure 9]

[0025] [[ID=3�]] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to at least one embodiment of the present disclosure. [Figure 10]

[0026] ]> Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to at least one embodiment of the present disclosure. [Figure 11]

[0027] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to at least one embodiment of the present disclosure. [Figure 12]

[0028] Cross-sectional view of at least a portion of an exemplary proximal end wire assembly, according to at least one embodiment of the present disclosure. [Figure 13]

[0029] This is a cross-sectional view of at least a portion of an example base core wire assembly according to at least one embodiment of the present disclosure. [Figure 14]

[0030] This is a side view of an intravascular device comprising a reinforced multifilament conductor bundle and a conductive trace according to at least one embodiment of the present disclosure. [Figure 15]

[0031] Figure 14 is a side view of the intravascular device, showing that an additional coated longitudinal trace is embedded in the intravascular device within the tip core compartment. [Figure 16]

[0032] This is a schematic diagram of a processor circuit according to at least one embodiment of the present disclosure. [Figure 17]

[0033] This is a cross-sectional view of at least a portion of an example wire assembly according to at least one embodiment of the present disclosure. [Modes for carrying out the invention]

[0018]

[0034] A metal ink conductor assembly is disclosed that provides single-layer or multi-layer coating of conductive metal ink traces, enabling improved electrical / mechanical performance and resolving manufacturing challenges associated with conductive filers or ribbons. Manufacturing or assembly processes requiring tensioning and coating of multifilament bundles or one or more conductive ribbons may benefit from the metal ink conductor assembly of this disclosure.

[0019]

[0035] Replacing embedded filers and / or flat ribbon wires with coatable conductive traces (e.g., nanometallic ink traces) allows for greater utilization of available space within the insulating layer, enabling the use of conductive materials with lower tensile strength and larger conductor cross-sections or surface areas. This allows for lower resistance / impedance along the entire length of the electromechanical device. As the ribbon and / or multifilar conductor bundles impart rigidity and local torque to the guidewire or catheter, the straightness and torque responsiveness of intraluminal devices with coatable conductive traces are also improved, leading to a reduction in mechanical "whipping" responsiveness when the device is operated within anatomical structures within blood vessels. Whipping refers to, for example, the inability to rotate smoothly around curves, causing the guidewire to bounce or twist within the blood vessel.

[0020]

[0036] Other manufacturing challenges are also mitigated by using the metal-ink conductor assemblies of this disclosure. For example, the process of laying multiple filers and / or flat ribbon wires while keeping them under tension and overcoating them with an insulating layer is extremely difficult. Some current processes can only be performed with two flat ribbon wires or multi-filer conductor bundles per device. Conversely, this disclosure allows for the implementation of any desired number of traces along the entire length of the device. Eliminating stretching and necking of the filers and / or ribbon wires reduces the occurrence of blistering in the insulating layer. During device assembly, twisting of the filers, filer bundles, and flat ribbon wires can make the downstream laser ablation process more difficult in terms of alignment. Furthermore, the processes used to create the filers and flat ribbon wires, and to embed them along the entire length of the device, approach the physical limits of the material, depending on the electrical / mechanical specifications of the electromechanical device. This sets limits on design and sourcing. The metal-ink conductor assemblies of this disclosure reduce or eliminate these difficulties.

[0021]

[0037] In this disclosure, a conductive ink (e.g., a nanometallic ink) is applied directly to an insulating polymer layer (e.g., polyimide) as a liquid, allowing it to evenly coat and conform to the insulating surface. Each layer of ink is then sintered, thereby transforming the liquid into a substantial solid metal having material properties equivalent to those of a bulk material. After sintering, additional insulating layers are coated to a desired thickness. Once the desired thickness is achieved, one or more nanometallic layers may then be individualized to create traces having a desired cross-sectional area. After individualization, the traces are coated with additional insulating layers to electrically isolate them. This process is repeated to create any desired number of layers and metal traces.

[0022]

[0038] Examples of devices incorporating multifilar conductor bundles and / or conductive ribbons include, for example, intraluminal medical guidewire devices described in U.S. Patent No. 10,595,820(B2), U.S. Patent Application Publications 2014 / 0187874, 2016 / 0058977, and 2015 / 0273187, and U.S. Provisional Patent Application No. 62 / 552,993 (filed August 31, 2017), each of which is incorporated herein by reference in its entirety as if it were fully described herein.

[0023]

[0039] These descriptions are provided for illustrative purposes only and should not be considered to limit the scope of the metal ink conductor assembly. Certain features may be added, excluded, or modified without departing from the subject matter of the claims.

[0024]

[0040] For the purpose of facilitating understanding of the principles of this disclosure, embodiments illustrated in the drawings are referenced here, and specific technical terms are used to describe them. Nevertheless, it is understood that no limitation to the scope of this disclosure is intended. Any changes and further modifications to the devices, systems and methods described, and any further applications of the principles of this disclosure, are fully contemplated and included within this disclosure as would normally be conceived by those skilled in the art relating to this disclosure. In particular, features, components, and / or steps described in relation to one embodiment are fully contemplated to be combined with features, components, and / or steps described in relation to other embodiments of this disclosure. Furthermore, although embodiments of this disclosure are described in relation to blood vessels, it is understood that the devices, systems and methods described herein are configured for use in any suitable anatomical structure or lumen of the body, including blood vessels, vascular lumens, esophagus, Eustachian tube, urethra, fallopian tube, intestine, colon, and / or any other suitable anatomical structure or lumen of the body. In other embodiments, the devices, systems, and methods described herein are used to examine any number of anatomical regions and types of tissues, including, but not limited to, organs such as the liver, heart, kidneys, gallbladder, pancreas, and lungs; structures of the nervous system, including ducts, intestines, brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and valves in blood vessels, cardiac chambers or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 is used to examine artificial structures such as cardiac valves, stents, shunts, filters, and other devices, but not limited to these. However, for the sake of brevity, numerous iterations of these combinations are not described separately.

[0025]

[0041] Figure 1 is a side view of an intravascular (e.g., intravascular) sensing system 100 comprising an intravascular device 102 comprising a conductive member 230 (e.g., a multifilar conductive bundle) and a conductive ribbon 260, according to an aspect of the present disclosure. The intravascular device 102 may be an intravascular guidewire, sized and molded for placement within a patient's blood vessel. The intravascular device 102 comprises a tip 108 and an electronic component 112. For example, the electronic component 112 may include, but is not limited to, a pressure sensor and / or flow sensor configured to measure the pressure of blood flow within a patient's blood vessel, or a temperature or image sensor, or a combination sensor that measures multiple characteristics. For example, flow data obtained by a flow sensor may be used to calculate physiological variables such as coronary flow reserve (CFR). The intravascular device 102 comprises a flexible stretch member 106. The electronic component 112 is arranged on the tip portion 107 of the flexible stretch member 106. In some embodiments, the electronic component 112 may be mounted on the tip portion 107 within the housing 280. The flexible tip coil 290 extends from the housing 280 toward the tip at the tip portion 107 of the flexible stretch member 106. The connecting portion 114 located at the base end of the flexible stretch member 106 comprises conductive portions 132, 134. In some embodiments, the conductive portions 132, 134 may be conductive ink printed and / or vapor-deposited around the connecting portion 114 of the flexible stretch member 106. In some embodiments, the conductive portions 132, 134 are conductive metal bands or rings arranged around the flexible stretch member. A locking area is formed by a collar or locking section 118 and a knob or retaining section 120 arranged at the base end portion 109 of the flexible stretch member 106.

[0026]

[0042] The intravascular device 102 in Figure 1 comprises a core wire having an end core 210 and a proximal core 220. The end core 210 and the proximal core 220 are metal components that form the main body portion of the intravascular device 102. For example, the end core 210 and the proximal core 220 are flexible metal rods that form the structure for the flexible extension member 106. The end core 210 and / or the proximal core 220 may be made from metal or a metal alloy. For example, the end core 210 and / or the proximal core 220 may be made from stainless steel, nitinol, nickel-cobalt-molybdenum alloy (e.g., MP35N), and / or other suitable materials. In some embodiments, the end core 210 and the proximal core 220 are made from the same material. In some embodiments, the end core 210 and the proximal core 220 are made from different materials. The diameters of the end core 210 and the proximal core 220 may vary along their respective total lengths. The junction between the tip core 210 and the base core 220 is surrounded and enclosed by the hypotube 215. In some cases, the electronic component 112 may be located at the tip of the tip core 210.

[0027]

[0043] In some embodiments, the intravascular device 102 comprises an end subassembly and a proximal subassembly, which are electrically and mechanically joined together, thereby providing electrical communication between the electronic component 112 and the conductive parts 132, 134. For example, flow data obtained by the electronic component 112 (in this example, the electronic component 112 is a flow sensor) can be transmitted to the conductive parts 132, 134. In an exemplary embodiment, the flow sensor 112 is a single ultrasonic transducer element. The transducer element emits an ultrasonic signal and receives the echo. The transducer element generates an electrical signal representing the echo. A signal carrier filer transmits this electrical signal from the sensor at the end to the connector at the proximal end. A processing system 306 processes the electrical signal to extract the fluid velocity.

[0028]

[0044] Control signals from a processing system 306 (e.g., a processor circuit of the processing system 306) communicating with the intravascular device 102 can be transmitted to the electronic component 112 via a connector 314 attached to the conductive parts 132, 134. The tip subassembly may comprise a tip core 210. The tip subassembly may also comprise the electronic component 112, a conductive member 230, and / or one or more layers 240 of insulating polymer / plastic surrounding the conductive member 230 and the core 210. For example, the polymer / plastic layer may insulate and protect the conductive member of the multifilar cable or conductor bundle 230. The proximal subassembly may comprise a proximal core 220. The proximal subassembly may also comprise one or more polymer layers 250 (hereinafter, polymer layer 250) surrounding the proximal core 220, and / or a conductive ribbon 260 embedded within one or more insulating and / or protective polymer layers 250. In some embodiments, the proximal subassembly and the tip subassembly are manufactured separately. During the assembly process of the intravascular device 102, the proximal subassembly and the tip subassembly may be joined together electrically and mechanically. As used herein, the flexible stretch 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), and / or one or more components of the tip subassembly 410 (e.g., including the tip core 210). Thus, the flexible stretch member refers to the combined proximal and tip subassemblies. The joint between the proximal core 220 and the tip core 210 is surrounded by a hypotube 215.

[0029]

[0045] In various embodiments, the intravascular device 102 may comprise one, two, three, or more cores extending along its entire length. For example, a single core may extend substantially along the entire length of the flexible extension member 106. In such embodiments, locking compartments 118 and 120 may be integrally formed at the proximal end portion of the single core. The electronic component 112 may be fixed at the tip portion of the single core. In other embodiments, such as the embodiment illustrated in Figure 1, locking compartments 118 and 120 may be integrally formed at the proximal end portion of the proximal core 220. The electronic component 112 may be fixed at the tip portion of the tip core 210. The intravascular device 102 comprises one or more conductive members 230 (e.g., multifilar conductor bundles or cables) communicating with the electronic component 112. For example, the conductive members 230 may be one or more wires directly communicating with the electronic component 112. In some examples, the conductive member 230 is electrically and mechanically connected to the electronic component 112, for example, by soldering. In some examples, the conductor bundle 230 comprises two or three wires (e.g., a bifilar cable or a trifilar cable). The individual wires may include bare metal conductors surrounded by one or more insulating layers. The conductive member 230 may extend along the entire length of the tip core 210. For example, at least a portion of the conductive member 230 may be spirally wrapped around the tip core 210 to minimize or eliminate the whipping effect of the tip core within the winding anatomical structure.

[0030]

[0046] The intravascular device 102 comprises one or more conductive ribbons 260 at the proximal end of a flexible stretchable member 106. The conductive ribbons 260 are embedded within a polymer layer 250. The conductive ribbons 260 are in direct contact with conductive portions 132 and / or 134. In some examples, the multifilar conductor bundle 230 is electrically and mechanically connected to an electronic component 112, for example, by soldering. In some examples, the conductive portions 132 and / or 134 include conductive ink (e.g., metallic nanoink such as copper, silver, gold, or aluminum nanoink) which is oriented and deposited or printed across the conductive ribbons 260.

[0031]

[0047] As described herein, electrical communication between the conductive member 230 and the conductive ribbon 260 can be established at the connecting portion 114 of the flexible stretchable member 106. By establishing electrical communication between the conductive bundle 230 and the conductive ribbon 260, the conductive portions 132, 134 can be electrically connected to the electronic component 112.

[0032]

[0048] In some embodiments shown in Figure 1, the intravascular device 102 comprises a locking compartment 118 and a retaining compartment 120. To form the locking compartment 118, machining processes are used to remove the polymer layer 250 and conductive ribbon 260 in the locking compartment 118, and to shape the proximal core 220 in the locking compartment 118 into a desired shape. As shown in Figure 1, the locking compartment 118 has a reduced diameter, while the retaining compartment 120 has a diameter substantially similar to that of the proximal core 220 in the connecting portion 114. In some examples, the machining process removes the conductive ribbon in the locking compartment 118, exposing the proximal end of the conductive ribbon 260 to moisture and / or liquids such as blood, saline solution, disinfectant, and / or enzymatic cleaning solution, so an insulating layer 158 is formed to insulate the exposed conductive ribbon 260, covering the proximal portion of the connecting portion 114.

[0033]

[0049] In some embodiments, the connector 314 provides electrical connectivity between the conductive parts 132, 134 and the patient interface monitor 304. The patient interface monitor 304 connects, in some cases, to a console or processing system 306, which includes or communicates with a display 308.

[0034]

[0050] System 100 is deployed in a catheterization laboratory equipped with a control room. The processing system 306 is located in the control room. In some cases, the processing system 306 may be located elsewhere, such as in the catheterization laboratory itself. The catheterization laboratory includes a sterile field, but its associated control room may or may not be sterile, depending on the procedure performed and / or the medical facility. In some embodiments, the device 102 is controlled from a remote location, such as a control room, so that the operator does not need to be in the immediate vicinity of the patient.

[0035]

[0051] The intratubular device 102, PIM 304, and display 308 are communicated to the processing system 306 directly or indirectly. These elements are communicated to the medical processing system 306 via wired connections such as a standard copper multifilar conductor bundle 230. The processing system 306 is communicated to one or more data networks, such as a local area network (LAN) based on TCP / IP. In other embodiments, different protocols, such as a synchronous optical network (SONET), are used. In some cases, the processing system 306 is communicated to a wide area network (WAN).

[0036]

[0052] The PIM304 transfers the received signal to the processing system 306, where the information is processed and displayed on the display 308 (for example, as physiological data in graph, symbol, or alphanumeric format). The console or processing system 306 may comprise a processor and memory. The processing system 306 is operable to facilitate the features of the intravascular sensing system 100 described herein. For example, the processor may execute computer-readable instructions stored in a non-temporary tangible computer-readable medium.

[0037]

[0053] The PIM304 facilitates signal communication between the processing system 306 and the intraluminal device 102. The PIM304 can be configured to communicate between the processing system 306 and the intraluminal device 102. In some embodiments, the PIM304 performs preliminary processing on the data before relaying it to the processing system 306. In examples of such embodiments, the PIM304 performs data amplification, filtering, and / or aggregation. In one embodiment, the PIM304 also supplies high or low voltage DC power to assist the operation of the intraluminal device 102 via a conductive member 230.

[0038]

[0054] A multifilar cable or transmission line bundle 230 may comprise multiple conductors, including one, two, three, four, five, six, seven, or more conductors. In the example shown in Figure 1, the multifilar conductor bundle 230 includes two linear sections 232 and 236, where the multifilar conductor bundle is positioned parallel to the longitudinal axis of the flexible extension member 106, and a helical section 234, where the multifilar conductor bundle 230 is wound around the outside of the flexible extension member 106 and then overcoated with an insulating and / or protective polymer 240. If present, communication along the multifilar conductor bundle 230 is through a number of methods or protocols, including serial, parallel, and others, where one or more filers of the bundle 230 transmit signals. One or more filers of the multifilar conductor bundle 230 may also transmit direct current (DC) power, alternating current (AC) power, or act as an earth connection.

[0039]

[0055] The display or monitor 308 is a display device such as a computer monitor or other type of screen. The display or monitor 308 is used to show the user selectable prompts, instructions, and visualizations of image data. In some embodiments, the display 308 is used to provide the user with a procedure-specific workflow for completing intraluminal imaging.

[0040]

[0056] Before continuing, please note that the above examples are provided for illustrative purposes only and are not intended to be limiting. Other devices and / or device configurations may be used to perform the operations described herein.

[0041]

[0057] Figure 2 is a side view of another type of intravascular device 102 according to an aspect of the present disclosure. The intravascular device 102 may be an intravascular guidewire, which is sized and molded for placement within a patient's blood vessel. The intravascular device 102 may comprise an electronic component 112. For example, the electronic component 112 may be a pressure sensor, or another type of sensor, configured to measure the pressure of blood flow within a patient's blood vessel. Pressure data obtained by the pressure sensor is used, for example, to calculate a physiological pressure ratio (e.g., FFR, iFR, Pd / Pa, or any other suitable pressure ratio). However, the device 102 may be used in any suitable anatomical structure or body lumen, including blood vessels, vascular lumens, esophagus, Eustachian tube, urethra, fallopian tube, intestine, colon, and / or any other suitable anatomical structure or body lumen.

[0042]

[0058] The intravascular device 102 comprises a flexible, extendable member 106, such as a guidewire. Electronic components 112 are arranged on the tip portion 107 of the flexible, extendable member 106. In some embodiments, the electronic components 112 may be mounted on the tip portion 107 within a housing 280. A flexible tip coil 290 extends between the housing 280 and the tip portion 108. Connecting components 114 are arranged on the proximal end portion of the flexible, extendable member 106. The connecting components include conductive portions 132, 134, and 136. In some embodiments, the conductive portions 132, 134, and 136 may be conductive inks printed or vapor-deposited around the flexible, extendable member. In some embodiments, the conductive portions 132, 134, and 136 are conductive metal rings or bands arranged around the flexible, extendable member. Locking compartments 118 and retaining compartments 120 are arranged on the proximal end portion of the flexible, extendable member 106.

[0043]

[0059] In some embodiments, the intravascular device 102 comprises an end subassembly 410 and a proximal subassembly 400, which are electrically and mechanically connected, thereby providing electrical communication between an electronic component 112 and conductive parts 132, 134, and 136. For example, pressure data obtained by the electronic component 112 (in this example, the electronic component 112 is a pressure sensor) can be transmitted to the conductive parts 132, 134, and 136. Control signals from a processing system communicating with the intravascular device 102 can be transmitted to the electronic component 112 via the conductive parts 132, 134, and 136. The end subassembly 410 may comprise an end core 210. The end subassembly 410 may also comprise the electronic component 112, a conductive member 230, and / or one or more layers 240 of polymer / plastic surrounding the conductive member 230 and the core 210. For example, the polymer / plastic layer may protect the conductive member 230. The proximal subassembly 400 may comprise a proximal core 220. The proximal subassembly 400 may also comprise one or more polymer layers 250 surrounding the proximal core 220, and / or a conductive ribbon 260 embedded within one or more polymer layers 250. In some embodiments, the proximal subassembly 400 and the tip subassembly 410 may be manufactured separately. During the assembly process of the intravascular device 102, the proximal subassembly 400 and the tip subassembly 410 can be electrically and mechanically joined together, and the joint may be sealed in a hypotube 215. As used herein, a flexible stretchable 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 400 (including, for example, the proximal core 220), and / or one or more components of the tip subassembly 410 (including, for example, the tip core 210).

[0044]

[0060] In various embodiments, the intravascular device 102 comprises one, two, three, or more cores extending along its entire length. For example, a single core may extend substantially along the entire length of the flexible extension member 106. In such embodiments, the locking compartment 118 and the retaining compartment 120 may be integrally formed at the proximal end portion of the single core. The electronic component 112 may be fixed at the tip portion of the single core. In other embodiments, such as the embodiment illustrated in Figure 2, the locking compartment 118 and the retaining compartment 120 may be integrally formed at the proximal end portion of the proximal core 220. The electronic component 112 may be fixed at the tip portion of the tip core 210. The intravascular device 102 comprises one or more conductive members 230 in communication with the electronic component 112. For example, the conductive members 230 may be one or more wires in direct communication with the electronic component 112.

[0045]

[0061] The intravascular device 102 comprises one or more conductive ribbons 260 at the proximal end of a flexible, stretchable member 106. The conductive ribbons 260 are embedded within a polymer layer 250. The conductive ribbons 260 are in direct contact with conductive portions 132, 134, and / or 136. In some examples, the conductive members 230 are electrically and mechanically connected to the electronic component 112, for example, by soldering, welding, terminals, clamps, conductive adhesive, or other suitable methods. In some examples, the conductive portions 132, 134, and / or 136 include conductive ink (e.g., metallic nanoink such as silver or gold nanoink) which is oriented and deposited or printed across the conductive ribbon 260.

[0046]

[0062] As described herein, electrical communication between the conductive member 230 and the conductive ribbon 260 can be established in the connection area 270 of the flexible stretchable member 106. By establishing electrical communication between the conductive member 230 and the conductive ribbon 260, the conductive portions 132, 134, and 136 can be electrically connected to the electronic component 112.

[0047]

[0063] In some examples, the machining process that forms the locking section 118 removes the conductive ribbon 260, exposing the base end of the conductive ribbon 260 to moisture and / or liquids such as blood, saline solution, disinfectant, and / or enzyme cleaning solution. In these cases, the insulating layer 158 may be formed to insulate the exposed conductive ribbon 260 by covering the base end portion of the connection section 114.

[0048]

[0064] Figure 3 is a perspective view of a multifilar conductor bundle 230 according to an aspect of the present disclosure. In the example shown in Figure 3, the multifilar conductor bundle 230 is a trifilar comprising three conductors 310, 320, and 330, each surrounded by insulating sheaths 315, 325, and 335. The insulating sheaths 315, 325, and 335 may or may not be covered with an additional overcoating 340, such as nylon or polyurethane, which joins the separate insulating sheaths 315, 325, and 335 together so that the filers 310, 320, and 330 form a single joined conductor bundle 230. The additional overcoating 340 is applied, for example, through a dip coating, but other methods may be used instead or in addition. For example, the individual insulating sheaths 315, 325, and 335 are joined to each other by welding using an adhesive or by any other preferred method. In some examples, the insulating sheaths 315, 325, and 335 are formed or extruded to cover the conductors in a single processing step. In conventional trifilers, all three conductors are of the same or similar diameter and are made from pure copper or a copper alloy such as BeCu. The multifiler conductor bundle 230 is shown here with conductors arranged in a planar configuration, but those skilled in the art will recognize that other arrangements may be used instead or in addition.

[0049]

[0065] During the manufacturing process of intravascular devices, filers are wrapped or pulled along the entire length of the device, from one end to the other. Since pure copper and many copper alloys have low tensile and yield strengths, the mechanical strength of conductive materials is typically very low. The manufacturing process of intravascular devices involves wrapping or stretching multifilament conductor bundles, which involves the application of tension. Unfortunately, this application of tension causes plastic deformation of the conductive filers, thereby resulting in serious undesirable elongation and / or constriction, for example, elongation of up to 100% in some current processes, along with bulging of insulation around the constricted areas. The associated narrowing of the conductor affects the mechanical strength and maximum current capacity of the filer, which can lead to manufacturing defects. Therefore, it is desirable to replace the filers with other types of conductors and / or replace the manufacturing process with one that does not require the pulling, wrapping, or tensioning of the conductors.

[0050]

[0066] Figure 4 is a cross-sectional view of at least a portion of an example base-end conductor assembly 400 according to an aspect of the present disclosure. The base-end conductor 220, two conductive ribbons 260, and layers of insulator 250 are visible. In some examples, the conductive ribbon 260 may also be used in place of the multifilar conductor bundle 230 in a tip-end conductor assembly 410 in a manner similar to that shown herein in Figure 4. The examples shown herein are idealized, free from manufacturing defects, and with all components aligned in the intended manner. However, in this idealized case, the thickness T1 of the insulator 250 covering the left and right edges of the conductive ribbon 260 is less than the thickness T2 of the insulator 250 covering the central part of the conductive ribbon 260. This occurs because the ribbon 260 comes off the spool in a flat shape and does not conform to the curvature of the conductor 220. Similarly, the thickness of the insulator 250 under the left and right edges of the conductive ribbon 260 is greater than the thickness of the insulator 250 under the central part of the conductive ribbon 260. The inherent stiffness of the flat conductive ribbon 260 also increases the stiffness of the tip core assembly 410, increasing the likelihood of weakening related to insulation fatigue or other durability issues, particularly where the insulator 250 is thinnest. Another challenge associated with using the flat conductive ribbon 260 in this manner is that variations in tension also result in a straightness of the base core section that, in some cases, exceeds what is considered acceptable for clinical use.

[0051]

[0067] Figure 5 is a cross-sectional view of at least a portion of an example base-end core wire assembly 400 according to an aspect of the present disclosure. This figure is a photograph showing possible configurations of the elements of Figure 4 in an unidealized manufactured product. The core wire 220, conductive ribbon 260, inner insulating coating 250, and outer insulating coating 255 are visible. As can be seen in the image, the alignment or inclination of the flat ribbon 260 relative to the round core wire 220 can create gaps 510 and thin areas 520 in the insulating coating 250. Note that the ribbon 260 is substantially flat because they are unwound from the spool during the assembly process. Due to the small cross-section and relatively rigid nature of the ribbon 260, the ribbon 260 does not conform to the curvature of the core wire.

[0052]

[0068] Figure 6 is a cross-sectional view of at least a portion of an example base core wire assembly 400 according to at least one embodiment of the present disclosure. In this configuration, conformal metal traces 660 are used as conductors instead of the ribbon conductors shown, for example, in the embodiment of Figure 1. The metal traces 660 are made from a coated conductive ink, such as nanometal ink. As the traces 660 follow the curves of the core wire 220, the insulator 250 maintains a constant thickness T3 on the traces 660 regardless of its position. This allows the conductor 660 to have a larger cross-sectional area (and therefore a larger current capacity) than the ribbon 260 without being wider, without reducing the thickness of the insulation 250 at the edges, and without increasing or significantly increasing the thickness of the insulation 250 used to completely cover and insulate the traces 660. Furthermore, as the traces 660 conform to the shape of the core wire 220, they do not add much rigidity to the base core wire assembly 400, and therefore improve the durability and fatigue resistance of the insulator 250. Another important aspect of nanometal ink 660 is that it allows for much wider traces, and therefore thinner traces overall, resulting in the same electrical quality as a flat ribbon. This can be a significant feature when considering the requirements for the diameter of the base core. A larger core diameter can lead to better control of the wire by the operator, as the traces stacked on top of it are thinner, resulting in better indentation and torque transmission.

[0053]

[0069] Since the traces 660 are coated or vapor-deposited rather than wrapped or tensioned, they can be made from mechanically weak conductive materials such as pure metal copper, for example, without the risk of stretching or constricting during the manufacturing process. In addition, vapor-deposited traces 660 conform to the shape or curvature of the wire, which can help reduce the cross-sectional dimensions or contour of the device 102. Conductive nanometal inks are used for this production process. Conductive nanometal inks are applied in many ways, including but not limited to inkjet printing, aerosol jet printing, felt / foam pad applicators, or immersion coating. In some embodiments, the material is cured or dried, and the traces are formed from the cured or dried material. In some embodiments, the coated material is sintered, for example, heated until the small metal particles in the coated ink melt together. Sintering can be done by oven, laser, torch, or by other means. Once cured, sintered, or otherwise made into a solid metal, one or more coated metal layers can be individualized by laser ablation, mechanical cutting / skiving, or any other method capable of precisely removing the metal and / or polymer material. This process can be carried out in a continuous reel-to-reel type combination coater / oven machine. In one example, ink application is performed with an ink-impregnated pad made from felt or foam, and individualization is performed by mechanical cutting. In another example, ink application is performed with an ink-impregnated felt or foam pad, and individualization is performed via laser ablation. In yet another example, ink application is performed by immersion coating. This metal-ink conductor assembly can be applied to any product using a conductor embedded in a composite subassembly.

[0054]

[0070] Figures 7 to 12 illustrate processing, assembly, or manufacturing steps used to create, for example, the conformal conductive trace 660 shown in Figure 6.

[0055]

[0071] Figure 7 is a cross-sectional view of at least a portion of an example base-end core wire assembly 400 according to at least one embodiment of the present disclosure. The manufacturing process of the example begins with the core wire 220 shown in the cross-section. The core wire 220 is made from, for example, stainless steel, but other materials including Nitinol or MP35N may be used instead or in addition.

[0056]

[0072] Figure 8 is a cross-sectional view of at least a portion of an example base-end core wire assembly 400 according to at least one embodiment of the present disclosure. In a first step of the example manufacturing process, a polymer coating 850 is applied to at least a portion of the core wire 220. The polymer coating 850 includes, for example, polyimide, polyamide, or other polymers in practice. The polymer coating 850 is applied, for example, by spraying, dip coating, coating with a felt or foam-impregnated pad, or by any other preferred technique.

[0057]

[0073] Figure 9 is a cross-sectional view of at least a portion of an example base-end core wire assembly 400 according to at least one embodiment of the present disclosure. In a second step of the example's manufacturing process, a conductive ink layer 960 is coated on the exterior of at least a portion of the polymer coating 850. The conductive ink 960 contains extremely fine or nanoscale particles of a conductive polymer (e.g., polyacetylene, polypyrrole, or polyaniline) or a metal (e.g., copper, silver, gold, or aluminum) suspended or solvated in a liquid carrier material, which evaporates after the coating step, for example, spontaneously or with the help of a drying oven or other heating or drying equipment, leaving a colloidal film of conductive particles. The conductive nanometal ink is applied by a variety of different methods, including but not limited to inkjet printing, aerosol jet printing, felt / foam pad applicators, or immersion coating. In some embodiments, once the carrier material has evaporated and the conductive material has dried and / or cured, the deposited conductive material 960 can be used in its coated (colloidal) state. In some embodiments, the conductivity and mechanical strength of the conductive trace may be further improved through sintering, which involves heating all or part of the material until the small conductive particles in the coated ink melt together to form a substantially continuous solid having properties similar to those of a bulk material. Sintering may be performed by an oven, laser, torch, or any other suitable technique.

[0058]

[0074] In some embodiments, the conductive ink or material is applied only to the periphery, and not to the entire periphery. For example, a longitudinal strip is printed or coated such that only the periphery of the polymer coating is covered with conductive ink. In these embodiments, individual traces are applied to an insulated core using, for example, inkjet printing, a continuous reel-to-reel process, etc. Individual traces may be applied one by one or simultaneously. These embodiments may or may not use the manufacturing steps depicted in Figures 10 and 11.

[0059]

[0075] Figure 10 is a cross-sectional view of at least a portion of an example base-end core wire assembly 400 according to at least one embodiment of the present disclosure. In a third step of the example manufacturing process, a second polymer coating 1050 is applied to at least a portion of the conductive coating 960. The polymer coating 1050 is made of the same or different material as the first polymer coating 850 and is applied by the same or different coating process. The polymer coating 1050 advantageously protects the edges of conductive traces created during cutting or skiving processes (e.g., as described with reference to Figure 11), thereby preventing the metal / conductive material from lifting or bending if there is no coating covering the metal / conductive material.

[0060]

[0076] Figure 11 is a cross-sectional view of at least a portion of an example base-end core wire assembly 400 according to at least one embodiment of the present disclosure. In a fourth step of the example manufacturing process, two or more cuts 1110 are made on at least a portion of the base-end core wire assembly such that at least portions of the outer polymer coating 1050 and the coated conductive layer 960 are removed. By implementation, portions of the inner polymer coating 850 are also removed, and in some cases, the cuts 1110 also remove a small amount of material from the core wire 220, which is beneficial to prevent or minimize this from happening. Once the cuts 1110 are complete, the coated conductive layer 960 is divided into separate areas, thereby forming longitudinal traces 660a and 660b that conform to the curvature of the core wire 220 and / or the curvature of the inner polymer coating 850, as shown, for example, in Figure 6. In one example, the longitudinal traces 660a and 660b each have an arc-shaped contour that forms a cylindrical portion concentric with the core wire 220 and / or the first insulating coating 850.

[0061]

[0077] It should be noted that in some examples, the cutting 1110 is performed before the outer polymer coating 1050 is deposited. However, this tends to result in rougher edges and more irregular depths, whereas cutting or skiving of the metal layer 960 with the outer polymer coating tends to result in a smoother cut.

[0062]

[0078] Figure 12 is a cross-sectional view of at least a portion of an example root core assembly 400 according to at least one embodiment of the present disclosure. In the fifth step of the example manufacturing process, a third polymer coating 1250 is applied to the outer surface of the isolated root core assembly 400. In some coating steps, due to surface tension, this outer polymer coating 1250 is thicker in areas where the isolated root core assembly 400 has a lower profile and thinner in areas where the isolated root core assembly 400 has a larger profile. As a result, the cross-section of the root core assembly 400 including the outer polymer coating 1250 tends to be circular or nearly circular. However, other cross-sectional shapes are also intended, including elliptical, oval, rectangular, triangular, or any other preferred cross-sectional shape. The outer polymer coating 1250 insulates the cut edges 1210 of the longitudinal trace 660, thus ensuring that they are electrically insulated from contact with each other, together with the core wire 220 and with conductive objects on the outside of the base core wire assembly 400.

[0063]

[0079] In some embodiments, longitudinal traces 660 formed of conductive ink may be used in place of, or in addition to, conductive metal ribbons 260 in the base core assembly 400, or in place of multifilar conductor bundles 230 in the tip core assembly 410. In some embodiments, an outer polymer coating 1250 is applied directly over the conductive traces 660, and then no polymer coating 1050 is applied at all. In some embodiments, an additional coating is applied over the outer polymer coating 1250 to, for example, reduce friction, improve lubricity, or alter the wettability of the device.

[0064]

[0080] In practice, the structure shown in Figure 12 may be formed around a base core wire, a tip core wire, or a core wire formed from a base core wire and a tip core wire.

[0065]

[0081] Figure 13 is a cross-sectional view of at least a portion of an example base core wire assembly 400 according to at least one embodiment of the present disclosure. This figure is a photograph showing possible configurations of the elements of Figure 12 in an unidealized manufactured product. The core wire 220, the conductive trace 660, and the insulating coatings 850, 1050, and 1250 are visible. The conductive trace 660 is completely surrounded by the insulating coatings 850 and / or 1050 so that the conductive trace 660 is electrically insulated from the core wire 220. The core wire 220 is also completely surrounded by the insulating coatings 850, 1050, and 1250. For example, the outer surface of the core 220 may be in contact with the insulating coatings 850, 1050, and / or 1250. As can be seen in the image, the insulating coating 1250 is substantially free of the voids and thin areas visible in Figure 5.

[0066]

[0082] Figure 14 is a side view of an intravascular device 102 comprising a reinforced multifilar conductor bundle 230 and a coated conductive trace 660, according to at least one embodiment of the present disclosure. The proximal core wire 220 and the tip core wire 210, joined by a hypotube 215, are visible. A coil 290 is located at the tip of the tip core wire, terminated by an electronic device 112 which is fully or partially enclosed within a housing 280. The reinforced multifilar conductor bundle 230, comprising conductive filers 310 and 330, is also visible. In some embodiments, the electronic device 112 is located at the proximal end of the coil 290 instead of at the tip of the coil 290. In such embodiments, the conductive filers 310 and 330 do not extend into the coil 290, but rather the proximal end of the coil 290 is terminated at the electronic device 112. In some embodiments, one electronic device 112 may be located at the tip of the intravascular device 102, and different electronic devices 112 may be positioned at intervals from the tip.

[0067]

[0083] The conductive filers 310 and 330 connect the electronic component 112 to an electrical contact 1010 formed in coated conformal longitudinal traces 660 that electrically contact the conductive areas 132 and 134. The reinforced multifilar conductor bundle 230 includes a straight section 232 that penetrates or passes along the coil 290. The reinforced multifilar conductor bundle 230 also includes a helical section 234 that wraps around the lead core wire 210 and is overcoated with an insulating or protective polymer coating 240. In addition, the reinforced multifilar conductor bundle 230 includes a straight section 236 that penetrates the hypo tube 215. Between the hypo tube 215 and the electrical contact 1010, the conductive filer is overcoated with a polymer coating 250. The installation of multifilar conductor bundles in these areas 232, 234, and 236 involves applying tension to the multifilar conductor bundles, which carries the risk of unwanted stretching and / or constriction of the conductors 230.

[0068]

[0084] Device 102 may comprise any preferred number of conductors in the bundle 230, including two, three, four, five, or more. Device 102 may comprise any preferred number of conductive traces 660, including two, three, four, five, or more. In some embodiments, device 102 comprises the same number of conductors in the bundle 230 as the number of conductive traces 660. In some embodiments, the number of conductors in the bundle 230 is greater than or less than the number of conductive traces 660. In this respect, in some embodiments, the bundle 230 comprises multiple conductors, such as the number of conductive traces 660. One additional conductor in the bundle 230 may be electrically and mechanically terminated at the core wire 220 for electrical grounding. Device 102 may comprise any preferred number of conductive areas 132 and 134, including two, three, four, five, or more. In some embodiments, the device 102 includes conductive traces 660 in the same number as conductive areas 132 and 134.

[0069]

[0085] Figure 15 is a side view of the intravascular device 102 of Figure 14, in which the multifilar conductive bundle 230 has been replaced with an additional coated longitudinal trace 1560. The coated longitudinal trace 1560 connects the electronic component 112 to an electrical contact 1010 formed on the coated longitudinal conductive trace 660, which electrically contacts the conductive areas 132 and 134. The coated longitudinal trace 1560 includes an area that penetrates the coil 290 and then the tip core wire 210, which is overcoated with an insulating or protective polymer coating 240. The coated longitudinal trace 1560 also includes an area that penetrates the hypotube 215. Between the hypotube 215 and the electrical contact 1010, the conductive trace 1560 is overcoated with a polymer coating 250.

[0070]

[0086] The installation of coated conductive traces 1560 in these areas does not require the application of tension, which carries the risk of unwanted stretching and / or constriction, thus improving the usability of the multifilament conductor bundle.

[0071]

[0087] Figure 16 is a schematic diagram of a processor circuit 1650 according to at least one embodiment of the present disclosure. The processor circuit 1650 is implemented in an intravascular sensing system 100 (e.g., a processing system 306), or in other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to carry out the method. As shown, the processor circuit 1650 comprises a processor 1660, a memory 1664, and a communication module 1668. These elements communicate with each other directly or indirectly, for example, via one or more buses.

[0072]

[0088] The processor 1660 includes any combination of other related logic devices, including a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or a general-purpose computing device, a reduced instruction set computing (RISC) device, an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or a mechanical and quantum computer. The processor 1660 also includes other hardware devices, firmware devices, or any combination thereof configured to perform the operations described herein. The processor 1660 is also implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors connected to a DSP core, or any other such configuration.

[0073]

[0089] Memory 1664 includes cache memory (e.g., the cache memory of processor 1660), 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 one embodiment, memory 1664 includes a non-temporary computer-readable medium. Memory 1664 stores instructions 1666. Instructions 1666, when executed by processor 1660, include instructions that cause processor 1660 to perform the operations described herein. Instructions 1666 are also referred to as code. The terms “instruction” and “code” should be interpreted broadly to include any type of computer-readable statement. For example, the terms “instruction” and “code” refer to one or more programs, routines, subroutines, functions, processes, etc. “Instruction” and “code” may include a single computer-readable statement or a number of computer-readable statements.

[0074]

[0090] The communication module 1668 may include any electronic and / or logic networks to facilitate direct or indirect communication of data between the processor circuit 1650 and other processors or devices. In this respect, the communication module 1668 may be an input / output (I / O) device. In some examples, the communication module 1668 facilitates direct or indirect communication between various elements of the processor circuit 1650 and / or the intravascular measurement system 100. The communication module 1668 communicates within the processor circuit 1650 through a number of methods or protocols. Serial communication protocols include US SPI, I 2This includes, but is not limited to, C, 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. Serial and parallel communications are bridged by a UART, USART, or another suitable subsystem, as needed.

[0075]

[0091] External communications (including, but not limited to, software updates, firmware updates, preset sharing between the processor and a central server, or readings from intraluminal devices) are performed using any suitable wireless or wired communication technology, such as cable interfaces like USB, micro USB, Lightning, or FireWire interfaces, Bluetooth®, Wi-Fi®, ZigBee®, Li-Fi, or cellular data communications such as 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G. For example, Bluetooth® Low Energy (BLE) radiotelegraphy may be used to establish connectivity with a cloud server for data transmission and software patch reception. The controller is configured to communicate with a remote server or a local device such as a laptop, tablet, or portable device, or it may have a display capable of showing state variables and other information. Information may also be transferred to a physical medium such as a USB flash drive or memory stick.

[0076]

[0092] Figure 17 is a cross-sectional view of at least a portion of an example core wire assembly 1700 according to at least one embodiment of the present disclosure. A core wire 220, which is a base core wire, a tip core wire, or a core wire including both base and tip core wires, is visible. Two layers of trace 660 with a first insulating coating, a second insulating coating 1050, and a third insulating coating 1250 are also visible. By embodiment, the insulating coatings 850, 1050, and 1250 are all made of the same material, all made of different materials, or any two of the three insulating coatings are made of the same material.

[0077]

[0093] Therefore, metal ink conductor assemblies advantageously reduce or eliminate the need to apply tension to multifilar conductor bundles and / or conductive ribbons, which are used in the manufacture of small electronic devices such as intravascular medical catheters or guidewires. This tends to eliminate the risk of stretching and / or constriction, which can impair the mechanical and electrical properties of the conductor, and further reduces the risk of gaps or thin spots in the outer insulating coating. Several modifications are possible to the above examples and embodiments. For example, the conductive ink may be coated in the form of individual traces rather than a uniform coating that is subsequently individualized by cutting.

[0078]

[0094] Metal ink conductor assemblies can be applied to any product involving conductors embedded in a composite subassembly. This disclosure enables conductors having a cross-sectional area similar to that of flat conductive ribbons. However, unlike conductive ribbons, these conductors can conform to the curvature of the core wire. This disclosure also creates a detectable material migration layer in the area where individualization takes place.

[0079]

[0095] The logical practices constituting embodiments of the technology described herein are referred to in various ways as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may be arranged or performed in any order unless otherwise expressly claimed or unless a particular order is essentially required by the language of the claims. It should also be understood that the described technology is used in single-use and multi-use electrical and electronic devices for medical or non-medical applications.

[0080]

[0096] References to all directions, e.g., top, bottom, inside, outside, upward, downward, left, right, side, front, back, upper, lower, up, down, vertical, horizontal, clockwise, counterclockwise, base, and tip, are used solely for identification purposes to facilitate the reader's understanding of the claimed subject matter and are not limiting, particularly with respect to the position, orientation, or use of the metal ink conductor assembly. References to connections, e.g., joining, linking, connection, and joining, should be taken broadly and, unless otherwise indicated, include intermediate members between groups of elements and relative movement between elements. Thus, references to connections do not necessarily mean that two elements are directly connected to each other and in a fixed relationship. The term “or” is to be interpreted as “and / or” rather than “exclusive OR.” The word “equipped with” does not exclude other elements or steps, and the singular form does not exclude the plural. Unless otherwise stated in the claims, stated values ​​are to be interpreted only as illustrative and not as limiting.

[0081]

[0097] The specifications, examples, and data described above provide a complete description of the structure and use of the metal ink conductor assembly as defined in the claims, as an example of an embodiment. Various embodiments of the claimed subject matter have been described above, with a certain degree of specificity, or by reference to one or more individual embodiments, but those skilled in the art can make numerous modifications to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter.

[0082]

[0098] Further embodiments are contemplated. All matters included in the foregoing description and shown in the accompanying drawings are intended to be construed as illustrating, and not limiting, a particular embodiment. Modifications in detail or structure are made without departing from the basic elements of the subject matter as defined in the following claims.

Claims

1. An intraluminal sensing device comprising a guidewire positioned within a lumen of a patient's body, wherein the guidewire is Core wire and, A first insulating coating covering at least a portion of the periphery of the conductor along at least a portion of the entire length of the conductor, At least two conductive traces, each having a certain thickness and a certain width, covering the outer surface of the first insulating coating and extending longitudinally along at least a portion of the total length of the core wire, wherein each conductive trace has a cross-sectional shape that conforms to the curvature of the first insulating coating, and the at least two conductive traces and the core wire are insulated from each other. A second insulating coating covering the outer surface of at least two conductive traces along at least a portion of the entire length of the core wire, A sensor is positioned within the lumen of the body to acquire physiological data, and is positioned at the tip of the guidewire to electrically communicate with the at least two conductive traces. A connector is positioned at the base end of the guide wire and electrically communicates with the at least two conductive traces. An intraluminal sensing device equipped with the following features.

2. The intraluminal sensing device according to claim 1, further comprising a third insulating coating that covers the upper surface of the second insulating coating along at least a portion of the total length of the core wire, and surrounds the entire circumference of the core wire.

3. The intraluminal sensing device according to claim 2, wherein the third insulating coating covers at least one portion of the conductive trace, the first insulating coating, or the core wire.

4. The intraluminal sensing device according to claim 2, wherein the at least two conductive traces include three conductive traces.

5. The intratubular sensing device according to claim 2, wherein the conductive trace includes conductive ink.

6. The intratubular sensing device according to claim 5, wherein the conductive ink is colloidal.

7. The intratubular sensing device according to claim 5, wherein the conductive ink is sintered.

8. The intratubular sensing device according to claim 5, wherein the conductive ink comprises at least one particle selected from gold, copper, silver, or aluminum.

9. The intratubular sensing device according to claim 2, wherein at least two of the first insulating coating, the second insulating coating, or the third insulating coating include the same insulating material.

10. The intratubular sensing device according to claim 2, wherein at least two of the first insulating coating, the second insulating coating, and the third insulating coating comprise different insulating materials.

11. The present invention further comprises at least two additional conductive traces, each having a certain thickness and a certain width, each covering the outer surface of the second insulating coating and extending longitudinally along at least the portion of the total length of the core wire, Each conductive trace has a cross-sectional shape that conforms to the curvature of the first insulating coating, The at least two conductive traces, the at least two additional conductive traces, and all of the core wires are insulated from each other. The intraluminal sensing device according to claim 2.

12. A guide wire for the intraluminal sensing device according to claim 1, A processor circuit communicates with the aforementioned guide wire, receives physiological data obtained by the sensor, processes the physiological data, and outputs a graph of the physiological data to a display that communicates with the processing system. An intraluminal sensing system equipped with the following features.

13. The intraluminal sensing system according to claim 12, further comprising a patient interface module (PIM).

14. Steps include: The steps include coating the entire circumference of the core wire with a first insulating material along at least a portion of its total length, The steps include coating the entire circumference of the core wire with the first insulating material and then coating it with conductive ink, along at least a portion of the total length of the core wire, The steps include coating the entire circumference of the core wire with the conductive ink to coat it with a second insulating material, along at least a portion of the total length of the core wire, The steps include removing material from at least the second insulating material and at least two surrounding arcs of the conductive ink so that the conductive ink forms at least two longitudinal conductive traces along at least the portion of the entire length of the core wire, and the at least two longitudinal conductive traces are electrically isolated from each other and from the core wire, The steps include: coating the second insulating material and the third insulating material around the entire circumference of the core wire, along at least a portion of the total length of the core wire and covering the two surrounding arcs; A method for manufacturing an intraluminal sensing guidewire having the following characteristics.

15. The method according to claim 14, wherein the at least two longitudinal conductive traces include three conductive traces.

16. The method according to claim 14, further comprising the step of sintering the conductive ink.

17. The method according to claim 14, wherein the conductive ink contains particles of gold, copper, silver, or aluminum.

18. The method according to claim 14, wherein at least two of the first insulating material, the second insulating material, or the third insulating material include the same insulating material.

19. The method according to claim 14, wherein at least two of the first insulating material, the second insulating material, and the third insulating material include different insulating materials.

20. An intravascular sensing device comprising a guidewire positioned together with the patient's blood vessel, wherein the guidewire is Core wire and, A first insulating coating covering at least a portion of the periphery of the conductor along at least a portion of the entire length of the conductor, At least two conductive traces comprising a sintered metal ink, each conductive trace having a certain thickness and a certain width, covering the outer surface of the first insulating coating and extending longitudinally along at least the portion of the total length of the core wire, each conductive trace having a cross-sectional shape that conforms to the curvature of the first insulating coating, and the at least two conductive traces and the core wire being insulated from each other, A second insulating coating covering the outer surface of at least two conductive traces along at least a portion of the entire length of the core wire, A third insulating coating covers the upper surface of the second insulating coating along at least a portion of the entire length of the core wire, surrounding the entire circumference of the core wire, and covering the conductive trace, the first insulating coating, or at least one portion of the core wire. At least one of a pressure sensor or a flow sensor is positioned at the tip of the guide wire and is in electrical contact with the at least two conductive traces, A connector is positioned at the base end of the guide wire and electrically communicates with the at least two conductive traces. An intravascular sensing device equipped with the following features.

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