Intraluminal physiologic sensing device with embedded conformal conductor

Abstract

An intraluminal sensing device includes a guidewire configured to be positioned within a body lumen of a patient. The guidewire includes a core wire, a first insulating coating covering at least a portion of a circumference of the core wire, and at least two conductive traces insulated from each other and extending longitudinally on an outer surface of the first insulating coating along at least a portion of a length of the core wire. Each conductive trace conforms to a curvature of the first insulating coating. The guidewire further includes a second insulating coating covering the conductive traces along at least a portion of the length of the core wire, and a sensor in electrical communication with the at least two conductive traces and configured to obtain physiological data while positioned within the body lumen. The guidewire further includes a proximal connector in electrical communication with the conductive traces.

Description

Technical Field

[0001] The topics described herein relate to intraluminal physiological sensing devices. For example, intravascular catheters or guidewires may include embedded, conformal metallic conductors and associated systems and methods. Background Technology

[0002] Intraluminal physiological sensing devices can be introduced into a patient's body lumen and may include, for example, physiological sensors located at the distal end of a catheter or guidewire. Wires can be used to connect the sensing element at the distal end of the catheter or guidewire to a connector located at the proximal end. Fine-gauge wires may be referred to as filaments. Small-diameter medical devices, such as intraluminal (e.g., intravascular) catheters and guidewires, may include sensors (e.g., pressure, temperature, flow, or imaging sensors), with power supply and communication achieved via multi-filament (e.g., bifilament, trifilament, etc.) conductor bundles or flat metal strips. In both cases, the reduction in device size presents challenges in the device manufacturing process related to the placement, winding, and securing of the conductors.

[0003] Guidewires and conduits are typically constructed from fine-gauge filaments and / or flat strips, enabling the transmission of electrical signals between electrical components within the device, such as sensors, transducers, and contacts. To achieve these connections, the filaments and / or flat strips can be embedded in a polymer along the length of the device via a winding or pulling process on a continuous roll-to-roll coating apparatus. A bundle of filaments can be connected into two, three, or more fine-gauge conductive filaments to establish electrical connections between electrical components, such as sensors or transducers near the distal end of the device and electrical contacts near the proximal end. To establish these connections, the filaments or strips can be wound or pulled along the length of the device from one end to the other. Due to the low tensile and yield strength of copper and many copper alloys, the mechanical strength of electrical conductor materials is generally low. The fabrication process of intraluminal conduits or guidewire devices may involve the winding or pulling of strips or multi-filament conductor bundles, which requires tensioning. Unfortunately, this tension causes plastic deformation of the conductive wire or strip, which can lead to severe, undesirable elongation and / or necking, for example, up to 100% elongation in some current processes. The associated conductor narrowing affects the wire's mechanical strength and maximum current capacity, which can result in manufacturing defects.

[0004] Some devices currently in use employ flat conductive metal strips, which can have current-carrying capacity comparable to wires, but are wider and shorter, potentially enabling small-diameter devices. These conductive strips can withstand tension better in some cases, but they do not conform to the cylindrical shape of a core wire, thus requiring thicker insulation to prevent conductor exposure at the strip edges. These strips are typically manufactured separately and must be added to the device. However, positioning and maintaining them in a straight line is challenging.

[0005] The information contained in the Background section of this specification, including any references cited herein and any descriptions or discussions thereof, is included for technical reference purposes only and should not be considered as subject to limiting the scope of this disclosure.

[0006] WO 2014 / 106158 A1, according to its abstract, relates to an intravascular device in the form of a guidewire, wherein an electrical conductor is printed on a solid core wire. In one case, the electrical conductor is coupled to a conductive strip adjacent to a proximal portion of the guidewire. The guidewire includes a body having an inner core and an outer layer having one or more embedded conductors. The conductors are exposed at one or more locations along the body, and conductive material may be layered at the exposed locations. A sensor may also be coupled to the body via conductive material at one of the exposed locations. US 2014 / 005543 A1, according to its abstract, relates to an intravascular device comprising at least one electronic, optical, or electro-optical component positioned within a distal portion of the device, and one or more connectors positioned at the distal portion of the device. In some cases, the connector is a flexible coil, such as a strip coil, formed of a conductive material. The conductive coil is embedded within a polymer tube. Furthermore, the optical or electro-optical component is positioned within a flexible element at the distal portion of the device. In some cases, the flexible element is a coil. US 2019 / 328245 A1, according to its abstract, relates to an electrophysiological catheter system for diagnosis and treatment in the myocardium, and more specifically, to a wireless force sensor mounted on the outer surface of the catheter shaft to detect forces applied to the catheter tip and wirelessly transmit a signal indicating the sensed force to a nearby wireless transceiver. Summary of the Invention

[0007] The object of the invention is achieved by the subject matter of the independent claims; further embodiments are incorporated in the dependent claims.

[0008] Disclosed is an intraluminal physiological sensing device comprising a metallic ink conductor assembly. In some aspects, the metallic ink conductor assembly can provide a single layer or multiple layers of conductive metallic ink traces, which allows for improved electrical / mechanical properties and reduces or eliminates manufacturing problems associated with conductive filaments or strips. The use of nano-metallic ink traces enables the use of conductive materials with lower tensile strength and larger conductor cross-sectional area or surface area. This provides lower resistance / impedance along the length of the electromechanical device, as well as improved straightness and torque response of the intraluminal device, while reducing manufacturing defects and simplifying the manufacturing process of the intraluminal device.

[0009] Nanometallic inks can be applied directly as liquid coatings onto an insulating polymer surrounding a core filament. Each layer of ink can then be sintered, transforming the coating into a solid metal with material properties equivalent to a bulk material. After sintering, additional insulating layers can be applied until the desired thickness is achieved. Once the desired thickness is reached, the nanometallic layers (one or more) can be segmented to form traces with a desired cross-sectional area.

[0010] The metallic ink conductor assembly disclosed in this article has specific, but not unique, utility for intraluminal medical catheters and guidewires.

[0011] One general aspect includes an endoluminal sensing device. The endoluminal sensing device includes a guidewire configured for positioning within a patient's body lumen, wherein the guidewire includes: a core wire; a first insulating coating covering at least a portion of the circumference of the core wire along its length; at least two conductive traces, each conductive trace including a thickness and a width, and extending longitudinally along at least a portion of the length of the core wire on an outer surface of the first insulating coating, wherein each conductive trace includes a cross-sectional shape conforming to the curvature of the first insulating coating, wherein the at least two conductive traces and the core wire are insulated from each other; and a second insulating coating covering at least a portion of the length of the core wire on the outer surfaces of the at least two conductive traces; a sensor configured to acquire physiological data when positioned within a body lumen, wherein the sensor is positioned at a distal portion of the guidewire and electrically communicates with the at least two conductive traces; and a connector positioned at a proximal portion of the guidewire and electrically communicates with the at least two conductive traces.

[0012] In some embodiments, the in-lumen sensing device further includes a third insulating coating that surrounds the entire circumference of the core filament along at least a portion of the length of the second insulating coating on the top surface of the core filament. In some embodiments, the third insulating coating covers multiple portions of at least one of the conductive traces, the first insulating coating, and the core filament. In some embodiments, at least two conductive traces comprise three conductive traces. In some embodiments, the conductive traces comprise conductive ink. In some embodiments, the conductive ink is gel-like. In some embodiments, the conductive ink is sintered. In some embodiments, the conductive ink comprises particles of at least one of gold, copper, silver, and aluminum. In some embodiments, at least two of the first, second, or third insulating coatings comprise the same insulating material. In some embodiments, at least two of the first, second, and third insulating coatings comprise different insulating materials. In some embodiments, each conductive trace comprises a cross-sectional shape conforming to the curvature of the first insulating coating, and at least two conductive traces, at least two additional conductive traces, and the core filament are all insulated from each other.

[0013] One general aspect includes an endoluminal sensing system. The system includes an endoluminal sensing guidewire and processor circuitry in communication with the endoluminal sensing guidewire. The processor circuitry is configured to receive physiological data acquired by sensors, process the physiological data, and output a graphical representation of the physiological data to a display in communication with the processing system. In some embodiments, the system further includes a patient interface module (PIM). Implementations may include hardware, methods, or processes, or computer software on a computer-accessible medium.

[0014] One general aspect includes a method for manufacturing an in-lumen sensing guidewire. The method includes providing a core wire; coating a first insulating material around the entire circumference of the core wire along at least a portion of its length; coating a conductive ink onto the first insulating material along at least a portion of the core wire's length and around the entire circumference of the core wire; coating a second insulating material onto the conductive ink along at least a portion of the core wire's length and around the entire circumference of the core wire; removing material from at least two circumferential segments of at least the second insulating material and the conductive ink, such that the conductive ink forms at least two longitudinal conductive traces along at least a portion of the core wire's length, wherein the at least two longitudinal conductive traces are electrically isolated from each other and from the core wire; and coating a third insulating material onto the second insulating material and the two circumferential segments along at least a portion of the core wire's length and around the entire circumference of the core wire.

[0015] In some embodiments, the at least two conductive traces comprise three conductive traces. In some embodiments, the method further comprises sintering conductive ink. In some embodiments, the conductive ink comprises 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 comprise the same insulating material. In some embodiments, at least two of the first insulating material, the second insulating material, and the third insulating material comprise different insulating materials.

[0016] One general aspect includes an intravascular sensing device comprising 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 circumference of the core wire along its length; at least two conductive traces comprising sintered metallic ink, each conductive trace comprising a thickness and a width, and extending longitudinally along at least a portion of the length of the core wire on the outer surface of the first insulating coating, wherein each conductive trace comprises a cross-sectional shape conforming to the curvature of the first insulating coating, wherein the at least two conductive traces and the core wire are insulated from each other; a second insulating coating covering at least a portion of the outer surface of the at least two conductive traces along its length; a third insulating coating covering the top surface of the second insulating coating around the entire circumference of the core wire along at least a portion of its length, wherein the third insulating coating covers multiple portions of at least one of the conductive traces, the first insulating coating, or the core wire; at least one of a pressure sensor or a flow sensor disposed at a distal portion of the guidewire and in electrical communication with the at least two conductive traces; and a connector disposed at a proximal portion of the guidewire and in electrical communication with the at least two conductive traces.

[0017] This summary portion is provided to present selected concepts in a simplified form, which will be further described in the detailed description portion. The summary portion is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A broader description of the features, details, functions, and advantages of the metal ink conductor assembly, as defined in the claims, will be provided in the following written description of various embodiments of this disclosure, and illustrated in the accompanying drawings. Attached Figure Description

[0018] Illustrative embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

[0019] Figure 1 This is a schematic side view of an intravascular sensing system according to various aspects of the present disclosure, the intravascular sensing system including an intravascular device including a conductive member and a conductive strip.

[0020] Figure 2 This is a schematic side view of another type of intravascular device according to several aspects of this disclosure.

[0021] Figure 3 This is a perspective view of a multi-wire conductor bundle according to various aspects of this disclosure.

[0022] Figure 4 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to various aspects of this disclosure.

[0023] Figure 5This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to various aspects of this disclosure.

[0024] Figure 6 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0025] Figure 7 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0026] Figure 8 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0027] Figure 9 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0028] Figure 10 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0029] Figure 11 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0030] Figure 12 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0031] Figure 13 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly according to at least one embodiment of the present disclosure.

[0032] Figure 14 This is a schematic side view of an intravascular device according to at least one embodiment of the present disclosure, the intravascular device including a reinforced multifilament electrical conductor bundle and conductive traces.

[0033] Figure 15 yes Figure 14 A schematic side view of an intravascular device, wherein additional coated longitudinal traces are embedded in the distal core portion of the intravascular device.

[0034] Figure 16 This is a schematic diagram of a processor circuit according to at least one embodiment of the present disclosure.

[0035] Figure 17 This is a cross-sectional view of at least a portion of an exemplary core wire assembly according to at least one embodiment of the present disclosure. Detailed Implementation

[0036] What is disclosed is a metallic ink conductor assembly that provides single-layer or multi-layer application of conductive metallic ink traces, which allows for improved electrical / mechanical properties and eliminates manufacturing problems associated with conductive filaments or strips. Manufacturing or assembly processes that require tensioning and coating of multiple filament bundles or one or more conductive strips can benefit from the metallic ink conductor assembly disclosed herein.

[0037] Replacing embedded filaments and / or flat strips with coatable conductive traces (e.g., nano-metallic ink traces) allows the use of conductive materials with lower tensile strength and larger conductor cross-sections or surface areas, as more of the available space within the insulation layer can be utilized. This can result in lower resistance / impedance along the length of the electromechanical device. The straightness and torque response of in-luminal devices with coatable conductive traces are also improved because the increased stiffness and local torque of the guidewire or catheter with strips and / or multi-filament conductor bundles can lead to reduced mechanical "whipping" response when manipulating the device within the intravascular anatomy. For example, whipping might indicate a failure to rotate smoothly around a curve, causing the guidewire to jump or jerk within the vessel.

[0038] Other manufacturing problems can also be alleviated by using the metallic ink conductor assembly of this disclosure. For example, the process of holding multiple filaments and / or flat strips under tension while laying and covering them with an insulation layer is very difficult. Some current processes can only be performed using two flat strips or multi-filament conductor bundles per device. In contrast, this disclosure enables any desired number of traces along the length of the device. Eliminating the elongation and necking of the filaments and / or strips reduces the occurrence of blistering within the insulation layer. During device assembly, the twisting of filaments, bundles, and flat strips makes alignment more difficult in downstream laser ablation processes. Furthermore, due to the electrical / mechanical specifications of electromechanical devices, the processes used to form the filaments and flat strips and embed them along the length of the device approach the physical limits of the materials. This creates design and sourcing limitations. The metallic ink conductor assembly of this disclosure reduces or eliminates these difficulties.

[0039] In this disclosure, a conductive ink (such as a nano-metallic ink) is directly coated as a liquid onto an insulating polymer layer (such as polyimide), allowing it to uniformly coat and conform to the insulating surface. Each layer of ink is then sintered, transforming the liquid into a solid metal that substantially possesses material properties equivalent to a bulk material. After sintering, additional insulating layers can be coated up to a desired thickness. When the desired thickness is reached, the nano-metallic layers (one or more layers) can be segmented to form traces with a desired cross-sectional area. After segmentation, these traces are coated with additional insulating layers to electrically isolate them. This process can be repeated to form any desired number of layers and metallic traces.

[0040] Exemplary devices comprising multifilament conductor bundles and / or conductive strips include, for example, endoluminal medical guidewire devices described in U.S. Patent No. 10,595,820B2, U.S. Patent Publications Nos. 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 fully set forth herein.

[0041] These descriptions are provided for illustrative purposes only and should not be construed as limiting the scope of the metallic ink conductor assembly. Some features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0042] For the purpose of promoting an understanding of the principles of this disclosure, reference will now be made to the embodiments shown in the accompanying drawings, and the embodiments described above will be used in specific language. However, it should be understood that no limitation is intended on the scope of this disclosure. Any changes and further modifications to the described apparatus, systems, and methods, as well as any further application of the principles of this disclosure, are fully contemplated and included within the scope of this disclosure, as would typically occur to those skilled in the art relating to this disclosure. Specifically, 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 this disclosure. Furthermore, while embodiments of this disclosure may be described with respect to blood vessels, it is understood that the apparatus, systems, and methods described herein may be configured for any suitable anatomical structure or body lumen, including blood vessels, vascular lumens, esophagus, Eustachian tubes, urethra, fallopian tubes, intestines, colon, and / or any other suitable anatomical structure or body lumen. In other embodiments, the devices, systems, and methods described herein can be used to examine any number of anatomical locations and tissue types, including, but not limited to: organs, including the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures, including the brain, dura mater, spinal cord, and peripheral nerves; the urinary tract; and valves within the blood vessels, chambers, or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 can also be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices. However, for the sake of brevity, multiple repetitions of these combinations will not be described separately.

[0043] Figure 1This is a schematic side view of an intraluminal (e.g., intravascular) sensing system 100 according to various aspects of the present disclosure, including an intravascular device 102 comprising a conductive member 230 (e.g., a multifilament conductor bundle) and a conductive strip 260. The intravascular device 102 may be an intravascular guidewire, sized and shaped for positioning within a patient's blood vessel. The intravascular device 102 includes a distal end 108 and electronic components 112. For example, the electronic components 112 may be a pressure sensor and / or a flow sensor configured to measure blood flow pressure within a patient's blood vessel, or other types of sensors, including but not limited to temperature sensors or imaging sensors, or a combination of sensors measuring more than one characteristic. For example, flow data obtained from a flow sensor may be used to calculate physiological variables such as coronary flow reserve (CFR). The intravascular device 102 includes a flexible elongated member 106. The electronic components 112 are disposed at a distal portion 107 of the flexible elongated member 106. In some embodiments, the electronic component 112 may be mounted within the housing 280 at the distal portion 107. At the distal portion 107 of the flexible elongated member 106, a flexible end coil 290 extends distally from the housing 280. A connection portion 114 disposed at the proximal end of the flexible elongated member 106 includes conductive portions 132, 134. In some embodiments, the conductive portions 132, 134 may be conductive ink, printed and / or deposited around the connection portion 114 of the flexible elongated member 106. In some embodiments, the conductive portions 132, 134 are conductive metal strips or rings positioned around the flexible elongated member. A locking region is formed by a collar or locking portion 118 and a knob or retaining portion 120 disposed at the proximal portion 109 of the flexible elongated member 106.

[0044] Figure 1The intravascular device 102 includes a core wire comprising a distal core 210 and a proximal core 220. The distal core 210 and proximal core 220 are metallic components forming part of the body of the intravascular device 102. For example, the distal core 210 and proximal core 220 may be flexible metal rods providing structure for a flexible elongated member 106. The distal core 210 and / or proximal core 220 may be made of metal or metal alloy. For example, the distal core 210 and / or proximal core 220 may be made of stainless steel, Nitinol, nickel-cobalt-chromium-molybdenum alloy (e.g., MP35N), and / or other suitable materials. In some embodiments, the distal core 210 and proximal core 220 are made of the same material. In other embodiments, the distal core 210 and proximal core 220 are made of different materials. The diameters of the distal core 210 and proximal core 220 may vary along their respective lengths. The connector between the distal core 210 and the proximal core 220 is surrounded and housed by a hypotube 215. Electronic components 112 may, in some cases, be positioned at the distal end of the distal core 210.

[0045] In some embodiments, the intravascular device 102 includes a distal subassembly and a proximal subassembly, which are electrically and mechanically connected together, forming electrical communication between the electronics 112 and the conductive portions 132, 134. For example, flow data obtained by the electronics 112 (in this example, the electronics 112 is a flow sensor) can be transmitted to the conductive portions 132, 134. 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 transmission filament transmits this electrical signal from the sensor located in the distal portion to a connector located in the proximal portion. The processing system 306 processes the electrical signal to extract the fluid flow rate.

[0046] Control signals from a processing system 306 (e.g., processor circuitry of the processing system 306) communicating with the intravascular device 102 can be transmitted to the electronics 112 via connector 314 attached to conductive portions 132, 134. The distal subassembly may include a distal core 210. The distal subassembly may also include the electronics 112, conductive members 230, and / or one or more layers of insulating polymer / plastic 240 surrounding the conductive members 230 and the core 210. For example, the polymer / plastic layers may insulate and protect the conductive members of the multifilament cable or conductor bundle 230. The proximal subassembly may include a proximal core 220. The proximal subassembly may also include one or more polymer layers 250 (hereinafter referred to as polymer layers 250) surrounding the proximal core 220 and / or conductive strips 260 embedded within one or more insulating and / or protective polymer layers 250. In some embodiments, the proximal and distal subassemblies are manufactured separately. During the assembly of the intravascular device 102, the proximal and distal subassemblies can be electrically and mechanically connected together. As used herein, a flexible elongated member can refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220, etc.), and / or one or more components of the distal subassembly 410 (e.g., including the distal core 210, etc.). Thus, a flexible elongated member can refer to the combined proximal and distal subassemblies described above. The connector between the proximal core 220 and the distal core 210 is surrounded by a hypotube 215.

[0047] In various embodiments, the intravascular device 102 may include one, two, three, or more mandrels extending along its length. For example, a single mandrel may extend substantially along the entire length of the flexible elongated member 106. In such embodiments, locking portions 118 and 120 may be integrally formed at the proximal portion of the single mandrel. Electronic components 112 may be secured at the distal portion of the single mandrel. In other embodiments, such as Figure 1In the illustrated embodiment, locking portions 118 and 120 may be integrally formed at the proximal portion of the proximal core 220. Electronic component 112 may be secured at the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 (e.g., multifilament conductor bundles or cables) communicating with the electronic component 112. For example, conductive member 230 may be one or more wires communicating directly with the electronic component 112. In some cases, conductive member 230 is electrically and mechanically coupled to the electronic component 112, for example, by brazing. In some cases, conductor bundle 230 includes two or three wires (e.g., two-wire or three-wire cables). Individual wires may comprise bare metal conductors surrounded by one or more insulating layers. Conductive member 230 may extend along the length of the distal core 210. For example, at least a portion of conductive member 230 may be helically wound around the distal core 210 to minimize or eliminate whiplash of the distal core in tortuous anatomical structures.

[0048] The intravascular device 102 includes one or more conductive strips 260 located at the proximal portion of a flexible elongated member 106. The conductive strips 260 are embedded within a polymer layer 250. The conductive strips 260 communicate directly with conductive portions 132 and / or 134. In some cases, a multifilament conductor bundle 230 is electrically and mechanically coupled to electronic components 112 by, for example, brazing. In some cases, conductive portions 132 and / or 134 comprise conductive ink (e.g., metallic nano-inks, such as copper, silver, gold, or aluminum nano-inks) that is directly deposited or printed onto the conductive strips 260.

[0049] As described herein, electrical communication between the conductive member 230 and the conductive strip 260 can be established at the connection portion 114 of the flexible elongated member 106. By establishing electrical communication between the conductor bundle 230 and the conductive strip 260, the conductive portions 132 and 134 can communicate electrically with the electronic component 112.

[0050] In the Figure 1 In some representative embodiments, the intravascular device 102 includes a locking portion 118 and a retaining portion 120. To form the locking portion 118, a machining process is used to remove the polymer layer 250 and conductive strip 260 from the locking portion 118 and to shape the proximal core 220 in the locking portion 118 into the desired shape. Figure 1As shown, the locking portion 118 includes a reduced diameter, while the diameter of the retaining portion 120 is substantially similar to the diameter of the proximal core 220 located in the connecting portion 114. In some cases, due to the removal of the conductive strip in the locking portion 118 during machining, the proximal end of the conductive strip 260 will be exposed to moisture and / or liquids, such as blood, saline solution, disinfectant and / or enzyme cleaning solution. Therefore, an insulating layer 158 is formed on the proximal portion of the connecting portion 114 to insulate the exposed conductive strip 260.

[0051] In some embodiments, connector 314 provides an electrical connection between conductive portions 132, 134 and patient interface monitor 304. Patient interface monitor 304 may, in some cases, be connected to or communicate with a console or processing system 306, which includes or communicates with a display 308.

[0052] System 100 may be deployed in a catheterization laboratory with a control room. Processing system 306 may be located in the control room. Alternatively, processing system 306 may be located elsewhere, such as within the catheterization laboratory itself. The catheterization laboratory may include a sterile area, while its associated control room may be sterile or may not be sterile, depending on the operation to be performed and / or the healthcare facility. In some embodiments, device 102 may be controlled from a remote location (such as a control room), eliminating the need for operator access to the patient.

[0053] The intraluminal device 102, PIM 304, and display 308 can be directly or indirectly communicatively connected to the processing system 306. These components can be communicatively connected to the medical processing system 306 via wired connections (such as a standard copper multi-wire conductor bundle 230). The processing system 306 can be communicatively connected 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 Network (SONET), can be utilized. In some cases, the processing system 306 can be communicatively connected to a wide area network (WAN).

[0054] The PIM 304 transmits the received signal to the processing system 306, where the information is processed and displayed (e.g., as physiological data in graphical, symbolic, or alphanumeric form) on the display 308. The console or processing system 306 may include 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 on a non-transitory tangible computer-readable medium.

[0055] PIM 304 facilitates signal communication between processing system 306 and in-lumen device 102. PIM 304 may be communicatively positioned between processing system 306 and in-lumen device 102. In some embodiments, PIM 304 performs preliminary data processing before data is transferred to processing system 306. In examples of such embodiments, PIM 304 performs data amplification, filtering, and / or aggregation. In one embodiment, PIM 304 also provides high-voltage and low-voltage DC power via conductive member 230 to support the operation of in-lumen device 102.

[0056] Multi-wire cable or transmission harness 230 may include multiple conductors, including one, two, three, four, five, six, seven or more conductors. Figure 1 In the example shown, the multi-filament conductor bundle 230 includes two straight portions 232 and 236 and a helical portion 234. In the two straight portions, the multi-filament conductor bundle 230 is laid parallel to the longitudinal axis of the flexible elongated member 106. In the helical portion, the multi-filament conductor bundle 230 is wound around the outside of the flexible elongated member 106 and then covered with an insulating and / or protective polymer 240. Communication along the multi-filament conductor bundle 230, if applicable, can be achieved by various methods or protocols, including serial, parallel, and other means, in which one or more filaments of the multi-filament conductor bundle 230 transmit signals. One or more filaments of the multi-filament conductor bundle 230 can also transmit direct current (DC) power, alternating current (AC) power, or serve as a ground connection.

[0057] The display or monitor 308 may be a display device such as a computer monitor or other type of screen. The display or monitor 308 may be used to display selectable prompts, instructions, and a visual representation of imaging data to a user. In some embodiments, the display 108 may be used to provide a user with an operation-specific workflow for performing intraluminal imaging operations.

[0058] Before proceeding, it should be noted that the examples described above are provided for illustrative purposes and are not intended to be limiting. Other devices and / or device configurations may be used to perform the operations described herein.

[0059] Figure 2This is a side view of another type of endovascular device 102 according to various aspects of this disclosure. Endovascular device 102 may be an endovascular guidewire, sized and shaped for positioning within a patient's blood vessels. Endovascular device 102 may include electronic components 112. For example, electronic components 112 may be a pressure sensor configured to measure blood flow pressure within a patient's blood vessels, or other types of sensors. For example, pressure data obtained from a pressure sensor may be used to calculate physiological pressure ratios (e.g., FFR, iFR, Pd / Pa, or any other suitable pressure ratio). However, device 102 may be used with any suitable anatomical structure or body lumen, including blood vessels, vascular lumens, esophagus, Eustachian tubes, urethra, fallopian tubes, intestines, colon, and / or any other suitable anatomical structure or body lumen.

[0060] The intravascular device 102 includes a flexible elongated member 106, such as a guidewire. An electronic component 112 is disposed at a distal portion 107 of the flexible elongated member 106. In some embodiments, the electronic component 112 may be mounted within a housing 280 at the distal portion 107. A flexible end coil 290 extends between the housing 280 and the distal end 108. A connection portion 114 is disposed at a proximal portion of the flexible elongated member 106. The connection portion includes conductive portions 132, 134, and 136. In some embodiments, the conductive portions 132, 134, and 136 may be conductive ink printed and / or deposited around the flexible elongated member. In some embodiments, the conductive portions 132, 134, and 136 are conductive metal rings or strips positioned around the flexible elongated member. A locking portion 118 and a retaining portion 120 are disposed at the proximal portion of the flexible elongated member 106.

[0061] In some embodiments, the intravascular device 102 includes a distal subassembly 410 and a proximal subassembly 400, which are electrically and mechanically coupled, providing electrical communication between electronics 112 and conductive portions 132, 134, 136. For example, pressure data obtained by electronics 112 (in this example, electronics 112 is a pressure sensor) can be transmitted to conductive portions 132, 134, 136. Control signals from a processing system communicating with the intravascular device 102 can be transmitted to electronics 112 via conductive portions 132, 134, 136. The distal subassembly 410 may include a distal core 210. The distal subassembly 410 may also include electronics 112, a conductive member 230, and / or one or more layers of polymer / plastic 240 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 include a proximal core 220. The proximal subassembly 400 may also include one or more polymer layers 250 surrounding the proximal core 220 and / or conductive strips 260 embedded within one or more polymer layers 250. In some embodiments, the proximal subassembly 400 and the distal subassembly 410 may be manufactured separately. During assembly of the intravascular device 102, the proximal subassembly 400 and the distal subassembly 410 may be electrically and mechanically connected together, and the connection may be enclosed within the hypotube 215. As used herein, a flexible elongated member may refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly 400 (e.g., including the proximal core 220, etc.), and / or one or more components of the distal subassembly 410 (e.g., including the distal core 210, etc.).

[0062] In various embodiments, the intravascular device 102 may include one, two, three, or more mandrels extending along its length. For example, a single mandrel may extend substantially along the entire length of the flexible elongated member 106. In such embodiments, a locking portion 118 and a retaining portion 120 may be integrally formed at the proximal portion of the single mandrel. Electronic components 112 may be secured at the distal portion of the single mandrel. In other embodiments, for example... Figure 2 In the illustrated embodiment, a locking portion 118 and a retaining portion 120 may be integrally formed at the proximal portion of the proximal core 220. The electronic component 112 may be secured at the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 communicating with the electronic component 112. For example, the conductive member 230 may be one or more wires directly communicating with the electronic component 112.

[0063] The intravascular device 102 includes one or more conductive strips 260 located at the proximal portion of a flexible elongated member 106. The conductive strips 260 are embedded within a polymer layer 250. The conductive strips 260 communicate directly with conductive portions 132, 134, and / or 136. In some cases, the conductive member 230 is electrically and mechanically coupled to the electronic component 112 by means of, for example, soldering, welding, terminals, clamps, conductive adhesives, or other suitable methods. In some cases, the conductive portions 132, 134, and / or 136 comprise conductive ink (e.g., metallic nano-ink, such as silver or gold nano-ink) that is directly deposited or printed onto the conductive strips 260.

[0064] As described herein, electrical communication between the conductive member 230 and the conductive strip 260 can be established at the connection region 270 of the flexible elongated member 106. By establishing electrical communication between the conductive member 230 and the conductive strip 260, the conductive portions 132, 134, and 136 can communicate electrically with the electronic component 112.

[0065] In some cases, the machining process that forms the locking portion 118 may remove the conductive strip 260, exposing the proximal end of the conductive strip 260 to moisture and / or liquids, such as blood, saline solution, disinfectant, and / or enzyme cleaning solution. In these cases, an insulating layer 158 may be formed on the proximal portion of the connecting portion 114 to insulate the exposed conductive strip 260.

[0066] Figure 3 This is a perspective view of a multi-wire conductor bundle 230 according to various aspects of this disclosure. Figure 3In the example shown, the multi-filament conductor bundle 230 comprises three filaments, each surrounded by an insulating sheath 315, 325, and 335, of which three conductors 310, 320, and 330 are respectively surrounded by insulating sheaths 315, 325, and 335. The insulating sheaths 315, 325, and 335 may, for example, comprise polyimide and may or may not be covered by an additional sheathing layer 340, such as nylon or polyurethane, which connects the individual insulating sheaths 315, 325, and 335 together, such that the filaments 310, 320, and 330 form a single connected conductor bundle 230. The additional sheathing layer 340 may be applied, for example, by dip coating, but other methods may be used instead or as a supplement. For example, the individual insulating sheaths 315, 325, and 335 may be attached to each other using adhesives, by welding, or any other suitable method. In some embodiments, the insulating sheaths 315, 325, and 335 are formed or extruded onto the conductor in a single processing step. In a traditional three-wire configuration, all three conductors can have the same or similar diameters and can be made of pure copper or copper alloys (such as BeCu). Although the multi-wire tube conductor bundle 230 shown here is arranged side-by-side in a planar manner, those skilled in the art will understand that other arrangements can be used instead or as supplements.

[0067] During the fabrication of intravascular devices, filaments can be wound or pulled along the length of the device from one end to the other. Due to the low tensile and yield strengths of pure copper and many copper alloys, the mechanical strength of electrical conductor materials is typically very low. The fabrication process of intravascular devices may involve winding or pulling multi-filament conductor bundles, which may involve tensioning. Unfortunately, this tensioning causes plastic deformation of the conductive filaments, which can lead to severe, undesirable elongation and / or necking; for example, in some current processes, elongation can reach up to 100%, while the insulation around the necked areas can blister. The associated conductor narrowing affects the mechanical strength and maximum current capacity of the filaments, which can lead to manufacturing defects. Therefore, it may be desirable to replace the filaments with other types of conductors, and / or to replace the fabrication process with one that does not require pulling, winding, or tensioning the conductors.

[0068] Figure 4 This is a cross-sectional view of at least a portion of an exemplary proximal filament assembly 400 according to various aspects of this disclosure. Visible are the proximal filament 220, two conductive strips 260, and an insulator layer 250. In some embodiments, the conductive strips 260 may also be present in the distal filament assembly 410 in a manner similar to... Figure 4The arrangement shown is used in place of the multi-filament conductor bundle 230. The example shown here is idealized, with all components aligned in a predetermined manner and without manufacturing defects. However, even in this idealized case, the thickness T1 of the insulator 250 at the left and right edges of the conductive strip 260 is less than the thickness T2 of the insulator 250 at the center of the conductive strip 260. This occurs because the strip 260 descends from the spool in a flat shape and does not conform to the curvature of the core filament 220. Similarly, the thickness of the insulator 250 below the left and right edges of the conductive strip 260 is greater than the thickness of the insulator 250 below the center of the conductive strip 260. The inherent stiffness of the flat conductive strip 260 also increases the stiffness of the distal core filament assembly 410 and increases the chance of fatigue-related insulation weakening or other durability problems, especially where the insulator 250 is thinnest. Another problem with using the flat conductive strip 260 in this manner is that, in some cases, tension variations can also affect the straightness of the proximal core filament portion beyond what is clinically acceptable.

[0069] Figure 5 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly 400 according to various aspects of this disclosure. The view is a photograph showing... Figure 4 The possible configurations of the components in a non-ideal manufactured product. Visible are the core wire 220, conductive strip 260, inner insulating coating 250, and outer insulating coating 255. As can be seen from the image, aligning or tilting the flat strip 260 on the circular core wire 220 creates gaps 510 and thin spots 520 in the insulating coating 250. It should be noted that the strips 260 are essentially flat because they have been unrolled from the reel during assembly. Due to the small cross-section and relatively rigid nature of the strips 260, they do not conform to the curvature of the core wire.

[0070] Figure 6 This is a cross-sectional view of at least a portion of an exemplary proximal core wire assembly 400 according to at least one embodiment of the present disclosure. In this configuration, a conformal metal trace 660 is used as a conductor, instead of, for example... Figure 1The embodiment shows a strip conductor. The metallic trace 660 is made of coated conductive ink (e.g., nano-metallic ink). Because the trace 660 follows the curve of the core filament 220, the insulator 250 maintains a constant thickness T3 on the trace 660, regardless of position. This allows the conductor 660 to be wider than the strip 260 and have a larger cross-sectional area (and therefore greater current carrying capacity) without reducing the thickness of the insulator 250 at the edges, and without increasing or significantly increasing the thickness of the insulator 250 used to completely cover and insulate the trace 660. Furthermore, since the traces 660 conform to the shape of the core filament 220, they do not add as much stiffness to the proximal core filament assembly 400, and thus improve the durability and fatigue resistance of the insulator 250. Another important aspect of the nano-ink trace 660 is that it allows for wider traces, thus allowing for thinner overall traces that provide the same electrical quality as a flat strip. This can be an important feature when considering the diameter requirements of the proximal core. A larger core diameter, with thinner traces stacked on top, allows the operator better control over the filament by providing better push and torque characteristics.

[0071] Because the traces 660 are coated or deposited, rather than wound or tensioned, they can be made of mechanically weak conductive materials (such as pure copper) without the risk of elongation or necking during manufacturing. Furthermore, the deposited traces 660 conform to the shape or curvature of the filament, which can be used to reduce the cross-sectional dimensions or profile of the device 102. Conductive nanometal inks can be used in this production process. Conductive nanometal inks can be applied in various ways, including but not limited to inkjet printing, aerosol jet printing, felt / foam pad applicators, or dip 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 using an oven, laser, torch, or other methods. Once cured, sintered, or otherwise transformed into a solid metal, the coated metal layer (one or more layers) can be separated by laser ablation, mechanical cutting / scraping, or any other method capable of precisely removing the metal and / or polymer material. This process can be implemented on continuous roll-to-roll type combination coating / oven equipment. In one example, ink is applied using an ink-impregnated pad made of felt or foam, and then segmented by mechanical cutting. In another example, ink is applied using an ink-impregnated felt or foam pad, and then segmented by laser ablation. In yet another example, ink is applied by dip coating. This metallic ink conductor assembly can be applied to any product employing an electrical conductor embedded in a composite subassembly.

[0072] Figures 7 to 12The diagram illustrates what can be used to form, for example Figure 6 The processing, assembly, or manufacturing steps of the conformal conductive trace 660 shown.

[0073] Figure 7 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly 400 according to at least one embodiment of the present disclosure. The exemplary manufacturing process begins with core filament 220, shown herein in cross-section. Core filament 220 may be made of stainless steel, for example, but other materials may be used instead or as a supplement, including Nitinol or MP35N.

[0074] Figure 8 This is a cross-sectional view of at least a portion of an exemplary proximal core filament assembly 400 according to at least one embodiment of the present disclosure. In a first step of the exemplary manufacturing process, a polymer coating 850 is applied to at least a portion of the core filament 220. The polymer coating 850 may, for example, comprise polyimide, polyamide, or other polymers, depending on the implementation. The polymer coating 850 may be applied, for example, by spraying, spraying, dipping, coating with a soaked felt or foam pad, or any other suitable technique.

[0075] Figure 9 This is a cross-sectional view of at least a portion of an exemplary proximal filament assembly 400 according to at least one embodiment of the present disclosure. In a second step of the exemplary manufacturing process, a conductive ink layer 960 is coated onto the exterior of at least a portion of a polymer coating 850. The conductive ink 960 may, for example, comprise micro- or nano-particles of a conductive polymer (e.g., polyacetylene, polypyrrole, or polyaniline) or a metal (e.g., copper, silver, gold, or aluminum), suspended or dissolved in a liquid carrier material that evaporates spontaneously or with the aid of a drying oven or other heating or drying equipment after the coating step, thereby leaving a gel-like film of conductive particles. Conductive nano-metallic inks can be applied by a variety of different methods, including but not limited to inkjet printing, aerosol jet printing, felt / foam pad applicators, or dip 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 employed in its coated (gel-like) state. In some embodiments, the conductivity and mechanical strength of the conductive traces can be further improved by sintering, which may involve heating all or part of the material until the small conductive particles in the coated ink melt into a substantially continuous solid with properties similar to those of a bulk material. Sintering can be performed using an oven, laser, torch, or any other suitable technique.

[0076] In some embodiments, the conductive ink or material may be applied only to multiple portions of the circumference, rather than around the entire circumference. For example, longitudinal strips may be printed or coated on it, such that only multiple portions of the circumference of the polymer coating are covered by the conductive ink. In these embodiments, individual traces are applied to the insulating core using, for example, inkjet printing, continuous roll-to-roll processes, etc. Individual traces may be applied one at a time or simultaneously. These embodiments may or may not employ these methods. Figure 10 and Figure 11 The manufacturing steps are illustrated in the diagram.

[0077] Figure 10 This is a cross-sectional view of at least a portion of an exemplary proximal filament assembly 400 according to at least one embodiment of the present disclosure. In a third step of the exemplary manufacturing process, a second polymer coating 1050 is applied to at least a portion of the conductive coating 960. The polymer coating 1050 may be the same as or different from the first polymer coating 850 and may be applied by the same or different coating processes. The polymer coating 1050 advantageously protects the edges of conductive traces generated during cutting or scraping (as shown in the reference). Figure 11 (As mentioned above), this may cause the metal / conductive material to lift or bend when there is no coating on it.

[0078] Figure 11 This is a cross-sectional view of at least a portion of an exemplary proximal filament assembly 400 according to at least one embodiment of the present disclosure. In a fourth step of the exemplary manufacturing process, two or more cuts 1110 are formed in at least a portion of the proximal filament assembly, such that multiple portions of at least the outer polymer coating 1050 and the coated conductive layer 960 are removed. According to embodiments, multiple portions of the inner polymer coating 850 may also be removed, and in some cases, the cuts 1110 may also remove a small amount of material from the filament 220, but preventing or minimizing this may be beneficial. Once the cuts 1110 are complete, the coated conductive layer 960 is divided into monomeric regions, thus forming longitudinal traces 660a and 660b that conform to the curvature of the filament 220 and / or the curvature of the inner polymer coating 850, for example in… Figure 6 As shown in the figure. In one example, longitudinal traces 660a and 660b each have an arcuate profile that forms multiple portions of a cylinder concentric with the core wire 220 and / or the first insulating coating 850.

[0079] It should be noted that in some cases, the cut 1110 may be formed before the outer polymer coating 1050 is deposited. However, this may tend to result in rougher edges and more irregular depths, while cutting or scraping the metal layer 960 and the outer polymer coating may tend to result in a cleaner cut.

[0080] Figure 12 This is a cross-sectional view of at least a portion of an exemplary proximal filament assembly 400 according to at least one embodiment of the present disclosure. In a fifth step of the exemplary manufacturing process, a third polymer coating 1250 is applied to the outer surface of the proximal filament assembly 400 of the monomer. During some coating processes, due to surface tension, the outer polymer coating 1250 may be thicker in regions of the proximal filament assembly 400 of the monomer with a lower profile and thinner in regions of the proximal filament assembly 400 of the monomer with a larger profile. Therefore, the cross-section of the proximal filament assembly 400 (including the outer polymer coating 1250) may tend to be circular or approximately circular. However, other cross-sectional shapes are also contemplated, including elliptical, oblong, oval, rectangular, triangular, or any other suitable cross-sectional shape. The outer polymer coating 1250 insulates the cut edges 1210 of the longitudinal traces 660, thereby ensuring that they are electrically insulated from each other, from the filament 220, and from conductive objects outside the proximal filament assembly 400 to prevent contact.

[0081] In some embodiments, longitudinal traces 660 formed with conductive ink may be used to replace the multifilament conductor bundle 230 in the distal filament assembly 410, except in replacing the conductive metal strip 260 in the proximal filament assembly 400 or in addition to replacing the conductive metal strip 260 in the proximal filament assembly 400. In some embodiments, the outer polymer coating 1250 may be applied directly to the conductive traces 660, while the polymer coating 1050 may not be applied at all. In some embodiments, additional coatings may be applied to the outer polymer coating 1250 to, for example, reduce friction, improve lubricity, or alter the wetting characteristics of the device.

[0082] According to the implementation method, Figure 12 The structure shown can be formed around a proximal core filament, a distal core filament, or a core filament formed by a proximal core filament and a distal core filament.

[0083] Figure 13 This is a cross-sectional view of at least a portion of an exemplary proximal filament assembly 400 according to at least one embodiment of the present disclosure. The view is a photograph showing a non-idealized manufactured product. Figure 12 Possible configurations of the components. Visible are the core filament 220, the conductive trace 660, and the insulating coatings 850, 1050, and 1250. The conductive trace 660 is completely surrounded by the insulating coatings 850 and / or 1050, making the conductive trace 660 electrically insulated from the core filament 220. The core filament 220 is also completely surrounded by the insulating coatings 850, 1050, and 1250. For example, the outer surface of the core filament 220 may be in contact with the insulating coatings 850, 1050, and / or 1250. As can be seen from the image, the insulating coating 1250 is essentially non-existent. Figure 5Visible gaps and thin spots.

[0084] Figure 14 This is a schematic side view of an intravascular device 102 according to at least one embodiment of the present disclosure, comprising a reinforced multifilament conductor bundle 230 and coated conductive traces 660. A proximal core filament 220 and a distal core filament 210 are visible, connected via a thiopanle 215. At the distal end of the distal core filament is a coil 290 terminating in an electronics device 112, which may be wholly or partially enclosed within a housing 280. Also visible is the reinforced multifilament conductor bundle 230, comprising conductive filaments 310 and 330. In some embodiments, the electronics device 112 may be located proximal to the coil 290, rather than distally. In such embodiments, conductive filaments 310 and 330 do not extend into the coil 290 but terminate proximal to the coil 290 at the electronics device 112. In some embodiments, one electronics device 112 may be located distally to the intravascular device 102, while different electronics devices 112 may be spaced apart from this distal end.

[0085] Conductive wires 310 and 330 connect electronic component 112 to electrical contacts 1010 formed on conformal, coated longitudinal traces 660, which form electrical contact with conductive regions 132 and 134. The reinforced multifilament conductor bundle 230 includes a straight region 232 passing through or along coil 290. The reinforced multifilament conductor bundle 230 also includes a helical region 234 wound around the distal core wire 210 and coated with an insulating or protective polymer coating 240. The reinforced multifilament conductor bundle 230 further includes a straight region 236 passing through the hysteresis tube 215. Between the hysteresis tube 215 and the electrical contacts 1010, the conductive wires are coated with a polymer coating 250. Placing the multifilament conductor bundle in these regions 232, 234, and 236 may involve tensioning of the multifilament conductor bundle, with the risk of undesirable elongation and / or necking of the conductor 230.

[0086] The device 102 may include any suitable number of conductors in the bundle 230, including two, three, four, five, or more. The device 102 may include any suitable number of conductive traces 660, including two, three, four, five, or more. In some embodiments, the device 102 includes 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 regard, in some embodiments, the bundle 230 includes one more conductor than the number of conductive traces 660. An additional conductor in the bundle 230 may terminate electrically and mechanically at the core filament 220 to provide electrical grounding. The device 102 may include any suitable number of conductive regions 132 and 134, including two, three, four, five, or more. In some embodiments, the device 102 includes the same number of conductive traces 660 as the conductive regions 132 and 134.

[0087] Figure 15 yes Figure 14 A schematic side view of the intravascular device 102, wherein the multi-filament electrical conductor bundle 230 has been replaced by an additional coated longitudinal trace 1560. The coated longitudinal trace 1560 connects the electronic component 112 to electrical contacts 1010 formed on the coated longitudinal conductive trace 1560, which form electrical contacts with conductive regions 132 and 134. The coated longitudinal trace 1560 includes a region passing through the coil 290, then along the distal core filament 210, and covered with an insulating or protective polymer coating 240. The coated longitudinal trace 1560 further includes a region passing through the hypotube 215. Between the hypotube 215 and the electrical contacts 1010, the conductive trace 1560 is covered with a polymer coating 250.

[0088] The placement of the conductive traces 1560 coated in these areas does not require tension and carries the risk of unwanted elongation and / or necking, and therefore represents an improvement over the use of multi-filament conductor bundles.

[0089] Figure 16 This is a schematic diagram of a processor circuit 1650 according to at least one embodiment of the present disclosure. The processor circuit 1650 may be implemented in the intravascular sensing system 100 (e.g., 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 required to implement the method. As shown, the processor circuit 1650 may include a processor 1660, a memory 1664, and a communication module 1668. These components may communicate directly with each other or indirectly, for example, via one or more buses.

[0090] Processor 1660 may include any combination of a central processing unit (CPU), digital signal processor (DSP), ASIC, controller, or general-purpose computing device, simplified instruction set computing (RISC) device, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other related logic device, including mechanical and quantum computers. Processor 1660 may also include another hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 1660 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 cooperating with a DSP core, or any other such configuration.

[0091] Memory 1664 may include cache memory (e.g., 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 storage 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-transitory computer-readable medium. Memory 1664 may store instructions 1666. Instructions 1666 may include instructions that, when executed by processor 1660, cause processor 1660 to perform the operations described herein. Instructions 1666 may also be 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” may refer to one or more programs, routines, subroutines, functions, procedures, etc. “Instruction” and “code” may include a single computer-readable statement or a number of computer-readable statements.

[0092] The communication module 1668 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect data communication between the processor circuitry 1650 and other processors or devices. In this respect, the communication module 1668 may be an input / output (I / O) device. In some cases, the communication module 1668 facilitates direct or indirect communication between the processor circuitry 1650 and / or various components of the intravascular measurement system 100. The communication module 1668 can communicate within the processor circuitry 1650 via a variety of methods or protocols. Serial communication protocols may include, but are not limited to, US SPI, I... 2C. Serial and parallel communication may be carried out using methods or protocols such as RS-232, RS-485, CAN, Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communication may be bridged via UART, USART, or another suitable subsystem.

[0093] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and the central server, or readings from devices within the lumen) can be accomplished using any suitable wireless or wired communication technology, such as cable interfaces (e.g., USB, micro USB, Lightning, or FireWire), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections (e.g., 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G). For example, Bluetooth Low Energy (BLE) radio can be used to establish connections to cloud services for data transfer and for receiving software patches. The controller can be configured to communicate with remote servers or local devices (e.g., laptops, tablets, or handheld devices) and may include a display capable of showing status variables and other information. Information can also be transmitted over physical media, such as USB flash drives or memory sticks.

[0094] Figure 17 This is a cross-sectional view of at least a portion of an exemplary filament assembly 1700 according to at least one embodiment of the present disclosure. The filament 220 is visible, which can be a proximal filament, a distal filament, or a filament including both proximal and distal filaments. Also visible are two layers of traces 660, and a first insulating coating 850, a second insulating coating 1050, and a third insulating coating 1250. According to embodiments, insulating coatings 850, 1050, and 1250 can all be made of the same material, can all be made of different materials, or any two of the three insulating coatings can be made of the same material.

[0095] Therefore, it can be seen that metallic ink conductor assemblies advantageously reduce or eliminate the need for tensioning multi-filament conductor bundles and / or conductive strips that can be used to manufacture small electronic devices such as intravascular medical catheters and guidewires. This tends to eliminate the risk of elongation and / or necking (which can impair the mechanical and electrical properties of the conductor) and reduce the risk of gaps or thin spots in the outer insulating coating. Many variations are possible in the examples and embodiments described above. For example, the conductive ink may be applied as a single trace rather than a uniform coating that is later segmented by cutting.

[0096] Metallic ink conductor assemblies can be applied to any product involving electrical conductors to be embedded in composite subassemblies. This disclosure allows conductors to have a cross-sectional area similar to that of flat conductive strips. However, unlike conductive strips, these conductors can conform to the curvature of a core filament. This disclosure also forms a detectable material transition layer in the region where the segmentation occurs.

[0097] The logical operations constituting embodiments of the technology described herein are referred to differently as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these operations can be arranged or performed in any order unless explicitly required otherwise, or the language of the requirement inherently necessitates a specific order. It should also be understood that the technology can be employed in single-use or multiple-use electrical and electronic devices for medical or non-medical purposes.

[0098] All directional references, such as up, down, inside, outside, upward, downward, left, right, side, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, near, and far, are used only for identification purposes to aid the reader in understanding the claimed subject matter and do not impose limitations, particularly regarding the location, orientation, or use of the metallic ink conductor assembly. Terms of connection, such as attachment, coupling, joining, and joining, should be interpreted broadly and may include intermediate members located between assemblies of elements and relative movement between elements, unless otherwise stated. Therefore, the term "connection" does not necessarily imply that two elements are directly connected and mutually fixed. The term "or" should be interpreted as "and / or," not "exclusively or." The word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude multiple. Unless otherwise stated in the claims, numerical values ​​should be interpreted as illustrative only and not as limiting.

[0099] The foregoing specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the metallic ink conductor assembly as defined in the claims. Although various embodiments of the claimed subject matter have been described above with reference to certain features or individual examples, those skilled in the art can make many changes to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter.

[0100] Other embodiments are also contemplated. All matters contained in the above description and shown in the accompanying drawings should be interpreted as merely illustrative of particular embodiments and not as limiting. Changes in detail or structure may be made without departing from the essential elements of the subject matter as defined in the following claims.

Claims

1. An intraluminal sensing device (102), comprising: Guidewire (106), configured to be positioned within a patient's body lumen, wherein the guidewire comprises: Core wire (220); A first insulating coating (850) covers at least a portion of the circumference of the core wire along at least a portion of its length; At least two conductive traces (660a, 660b), each conductive trace comprising a thickness and a width, extending longitudinally along at least a portion of the length of the core filament on the outer surface of the first insulating coating, wherein each conductive trace comprises a cross-sectional shape conforming to the curvature of the first insulating coating, wherein the at least two conductive traces and the core filament are insulated from each other; and A second insulating coating (1050) covers the outer surface of the at least two conductive traces along at least a portion of the length of the core wire. Sensor (112), configured to acquire physiological data when positioned within the body lumen, wherein the sensor is positioned at a distal portion of the guidewire and in electrical communication with the at least two conductive traces; and A connector (314) is positioned at the proximal portion of the guidewire and is in electrical communication with the at least two conductive traces.

2. The intraluminal sensing device according to claim 1, wherein, The in-cavity sensing device further includes a third insulating coating (1250) that surrounds the entire circumference of the core wire on the top surface of the second insulating coating along at least a portion of the length of the core wire.

3. The intraluminal sensing device according to claim 2, wherein, The third insulating coating covers multiple portions of at least two conductive traces, the first insulating coating, and at least one of the core wires.

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

5. The intraluminal sensing device according to claim 2, wherein, The at least two conductive traces include conductive ink.

6. The intraluminal sensing device according to claim 5, wherein, The conductive ink is gel-like.

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

8. The intraluminal sensing device according to claim 5, wherein, The conductive ink comprises particles of at least one of gold, copper, silver, and aluminum.

9. The intraluminal sensing device according to claim 2, wherein, At least two of the first insulating coating, the second insulating coating, and the third insulating coating include: i) The same insulation material; or ii) Different insulating materials.

10. The intraluminal sensing device according to claim 2, wherein, The in-cavity sensing device further includes at least two additional conductive traces, each additional conductive trace having a thickness and a width, and each additional conductive trace extending longitudinally along at least a portion of the length of the core wire on the outer surface of the second insulating coating. Each additional conductive trace includes a cross-sectional shape conforming to the curvature of the second insulating coating, and The at least two conductive traces, the at least two additional conductive traces, and the core wire are all insulated from each other.

11. The intraluminal sensing device according to claim 1, wherein, The guidewire is configured to be positioned within the patient's blood vessels; Wherein, the at least two conductive traces comprise sintered metallic ink, The guide wire further includes a third insulating coating that surrounds the entire circumference of the core wire on the top surface of the second insulating coating along at least a portion of the length of the core wire, wherein the third insulating coating covers multiple portions of at least two conductive traces, the first insulating coating, and at least one of the core wire; and The sensor includes at least one of a pressure sensor and a flow sensor.

12. An intraluminal sensing system, comprising: The intracavitary sensing device according to claim 1; as well as A processor circuit that communicates with the intraluminal sensing device, wherein the processor circuit is configured to receive physiological data obtained by the sensors of the intraluminal sensing device, process the physiological data, and output a graphical representation of the physiological data to a display that communicates with the processor circuit.

13. The intraluminal sensing system according to claim 12, wherein, The intraluminal sensing system also includes a patient interface module.

14. A method for manufacturing an intraluminal sensing guidewire, comprising: Provide core wire; A first insulating material is coated around the entire circumference of the core wire along at least a portion of its length; Conductive ink is coated on the first insulating material along at least a portion of the length of the core wire, around the entire circumference of the core wire; A second insulating material is coated on the conductive ink along at least a portion of the length of the core wire, around the entire circumference of the core wire; Material is removed from at least two circumferential segments of at least the second insulating material and the conductive ink, such that the conductive ink forms at least two longitudinal conductive traces along at least a portion of the length of the core filament, wherein the at least two longitudinal conductive traces are electrically isolated from each other and from the core filament. as well as A third insulating material is coated on the second insulating material and the two circumferential arc segments along at least a portion of the length of the core wire, around the entire circumference of the core wire.

15. The method according to claim 14, wherein, The method further includes sintering the conductive ink.

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