Sensor mount for intravascular devices with integrated conductive pads for electrical connection to the sensor.

Abstract

An intraluminal device is provided. The intraluminal device includes a flexible elongated member configured to be placed in a patient's body cavity, and a sensor mount positioned distal to the flexible elongated member. The sensor mount includes a first plurality of conductive pads. The sensor mount additionally includes a sensor assembly. The sensor assembly includes a sensor and a second plurality of conductive pads. The second plurality of conductive pads are electrically and mechanically coupled to the first plurality of conductive pads.

Description

Technical Field

[0001] The present disclosure generally relates to intravascular measurement devices (e.g., intravascular catheters or guidewires). In particular, the sensor mount includes a plurality of conductive pads that enable electrical connection to a sensor (e.g., an intravascular pressure sensor) attached to the sensor mount.

Background Art

[0002] Intravascular measurement devices are commonly used in medical diagnosis to provide insights to physicians regarding a patient's health. For example, an intravascular measurement device can acquire pressure, flow, or image data from within a patient's lumen, such as a blood vessel. This data may be used by a physician to diagnose various conditions and develop treatment plans. In essence, intravascular measurement devices are designed to be small, flexible, and placed and moved through a patient's lumen. Thus, the assembly of such devices can be very complex.

[0003] Particularly, current methods of assembling intravascular measurement devices, such as intravascular pressure measurement devices designed to measure blood pressure within a blood vessel, involve manual processes. These include the use of tweezers to attach to a sensor mount. Typically, a set of conductive wires is passed through an opening in a housing and the sensor is placed within the opening of the housing. The wires must then be electrically and mechanically coupled to the sensor.

Summary of the Invention

Problems to be Solved by the Invention

[0004] This manual process frequently results in damage to wires and sensors. The components are so small and delicate that handling them with tweezers without causing damage can be difficult. Damage can occur during any step of the assembly process, from attaching the wires to the sensors to securing the sensors to the mounts. Furthermore, damage may not be immediately apparent in many cases. Damage may not be detected until the device is fully assembled and tested, which can be a time-consuming and costly process. If damage is detected at this stage, the device may need to be disassembled and the assembly process redone, which can further increase costs and delay time to market. [Means for solving the problem]

[0005] This disclosure introduces a sensor mount designed for the automated assembly of intravascular measuring devices (e.g., intravascular catheters or guidewires). An intravascular sensor is mounted on the sensor mount (e.g., an intravascular pressure sensor mounted on a pressure sensor mount). The sensor mount provides an electrical signal connection between a sensor located at the distal end of the intravascular device and a conductor extending from the distal to the proximal end of an intravascular guidewire. In this respect, the sensor mount is both a physical mount and an electrical interposer for the sensor. The sensor mount helps reduce manual assembly, lower the risk of damage, and increase assembly speed and efficiency. The mount includes two proximal conductive pads and three distal conductive pads, as well as an area for mechanically bonding the sensor assembly. Two of the distal pads transmit positive and negative signals, which are isolated but communicate electrically with the proximal pads. These pads are connected to conductors extending to a control system outside the patient's body. The third distal pad corresponds to a ground signal that communicates electrically and mechanically with the sensor mount and core wire. The device's components are configured to enable automated assembly, improving reliability, speed, and efficiency.

[0006] In an exemplary embodiment, an intraluminal device is provided. The intraluminal device includes a flexible elongated member configured to be positioned within a patient's body cavity; a sensor mount positioned distal to the flexible elongated member and having a first plurality of conductive pads; a sensor assembly positioned on the sensor mount and configured to acquire intraluminal medical data related to the body cavity; and a sensor assembly having a second plurality of conductive pads electrically coupled to the first plurality of conductive pads.

[0007] In some embodiments, the number of second plurality of conductive pads is equal to the number of first plurality of conductive pads. In some embodiments, the sensor mount further has a third plurality of conductive pads. In some embodiments, the third plurality of conductive pads includes a first conductive pad, a second conductive pad, and a third conductive pad. In some embodiments, one portion of the conductive pads among the first plurality of conductive pads forms a layer of the first conductive pad of the third plurality of conductive pads. In some embodiments, one portion of the conductive pads among the first plurality of conductive pads forms a layer of the third conductive pad of the third plurality of conductive pads. In some embodiments, the second conductive pad among the third plurality of conductive pads is electrically coupled to ground. In some embodiments, the first plurality of conductive pads are located within a cavity of the sensor mount. In some embodiments, a dielectric filler is located within the cavity of the sensor mount. In some embodiments, the dielectric filler electrically insulates the first plurality of conductive pads from the sensor mount. In some embodiments, the first plurality of conductive pads includes three conductive pads. In some embodiments, two of the first plurality of conductive pads are electrically coupled to corresponding cables extending along a flexible elongated member. In some embodiments, the sensor assembly is configured to be mechanically coupled to a sensor mount via an adhesive. In some embodiments, the sensor assembly is configured to be automatically mechanically coupled to a sensor mount by a machine. In some embodiments, a wire bond is mechanically placed between the first plurality of conductive pads and a second plurality of conductive pads. In some embodiments, the sensor mount is housed within a housing. In some embodiments, the housing includes an opening having a proximal end and a distal end, the proximal end being located adjacent to the first plurality of conductive pads of the sensor mount. In some embodiments, the width of the proximal end of the opening is wider than the width of the central portion of the opening.

[0008] In an exemplary embodiment, an apparatus is provided which includes an intravascular guidewire configured to be placed inside a blood vessel and having an intravascular pressure sensor which has a first plurality of conductive pads, a second plurality of conductive pads positioned distal to the first plurality of conductive pads, and a third plurality of conductive pads positioned on a sensor mount and electrically coupled to the second plurality of conductive pads, wherein the first plurality of conductive pads are electrically coupled to a plurality of corresponding conductors extending along the length of the intravascular guidewire.

[0009] In some embodiments, the number of the second plurality of conductive pads is greater than the number of the first plurality of conductive pads.

[0010] Further aspects, features, and advantages of this disclosure will become apparent from the following detailed description.

[0011] Exemplary embodiments of this disclosure will be described with reference to the accompanying drawings. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic diagram of an intravascular sensing system including an intravascular device according to an aspect of the present disclosure. [Figure 2] This is a schematic diagram of a processor circuit according to the embodiments of this disclosure. [Figure 3] This is a perspective view of a sensor mount for an intravascular device according to an aspect of this disclosure. [Figure 4A] This is a schematic diagram of a sensor assembly coupled to a sensor mount of an intravascular device according to an aspect of the present disclosure. [Figure 4B] This is an enlarged schematic top view of a sensor mount for an intravascular device according to an aspect of the present disclosure. [Figure 5] This is a schematic diagram of the signal path of an intravascular sensing system according to the embodiments of this disclosure. [Figure 6A] This is a cross-sectional perspective view of a sensor mount according to an aspect of this disclosure. [Figure 6B] This is a cross-sectional side view of a sensor mount according to an aspect of the present disclosure. [Figure 7A] This is a cross-sectional perspective view of a sensor mount according to an aspect of this disclosure. [Figure 7B] This is a cross-sectional side view of a sensor mount according to an aspect of the present disclosure. [Figure 8] This is a cross-sectional side view of an intravascular device according to an aspect of the present disclosure. [Figure 9A] This is a top view of the housing of an intravascular device according to an aspect of the present disclosure. [Figure 9B] This is a top view of the housing of an intravascular device according to an aspect of the present disclosure. [Figure 9C] This is a top view of the housing of an intravascular device according to an aspect of the present disclosure. [Figure 10A] This is a top view of a sensor assembly and housing for an intravascular device according to an aspect of the present disclosure. [Figure 10B] This is a top view of a sensor assembly and housing for an intravascular device according to an aspect of the present disclosure. [Figure 11] This is a flowchart of a method for assembling an intravascular device according to an aspect of this disclosure. [Modes for carrying out the invention]

[0013] For the purpose of facilitating the understanding of the principles of this disclosure, embodiments shown in the drawings are referenced herein, and specific language is used to describe them. Nevertheless, it is understood that no limitation of the scope of this disclosure is intended. Any changes and further modifications to the apparatus, systems, and methods described herein, as well as any further applications of the principles of this disclosure, are fully conscientious and included herein, as would be commonly conceived by those skilled in the art to whom this disclosure relates. In particular, it is fully conscientious that features, components, and / or steps described in relation to one embodiment may be combined with features, components, and / or steps described in relation to other embodiments of this disclosure. However, for the sake of brevity, numerous iterations of these combinations are not described separately.

[0014] Embodiments of the present disclosure are systems, devices, and methods for a sensor mount for automated assembly of an intravascular pressure measurement device. The sensor mount disclosed herein advantageously reduces the required manual assembly by enabling mechanical assembly of the sensor assembly. This advantageously reduces the risk of damage to components and increases the assembly speed and efficiency of the sensor assembly. Also, the disclosed sensor mount advantageously reduces the number of conductor wires extending along the flexible elongate member.

[0015] The sensor mount includes two proximal conductive pads and three distal conductive pads. The sensor mount includes an area to which a sensor assembly can be bonded, for example, via a pick-and-place machine process. The three distal conductive pads of the mount are positioned adjacent to the three corresponding conductive pads of the sensor assembly. The machine may form a wire bond that electrically connects the distal conductive pads of the sensor mount to the three corresponding conductive pads of the sensor assembly. In some embodiments, the wire bond may be alternatively referred to as a bond wire or conductive trace. Two of the three distal conductive pads may transmit positive and negative signals from the sensor assembly, respectively. These two distal conductive pads may be electrically isolated from the sensor mount. These two distal conductive pads electrically communicate with the two proximal conductive pads. The two conductors may be electrically and mechanically coupled to the proximal conductive pads and may extend along the interior of the intravascular device to an extrapatient control system. A third distal conductive pad may correspond to a ground signal. A third distal conductive pad may communicate electrically and mechanically with a sensor mount. The sensor mount may extend along the interior of the intravascular device and communicate electrically and mechanically with a core wire that transmits a ground signal from the device to a control system. The housing includes openings arranged around the device and sized and shaped to accommodate components of an automated machine used to assemble the device. In this way, the arrangement of the components of the disclosed device advantageously allows the device to be assembled according to an automated process by machine, significantly reducing or completely eliminating manual assembly and improving reliability, speed, and efficiency.

[0016] FIG. 1 is a schematic diagram of an intravascular sensing system 100 including an intravascular device 102 according to an aspect of the present disclosure. The intravascular device 102 can be an intravascular guide wire sized and shaped to be disposed within a patient's blood vessel. The intravascular device 102 includes a distal tip 108 and electronic components 112. For example, the electronic components 112 can include, but are not limited to, a pressure sensor and / or a flow sensor configured to measure the pressure of blood flow within a patient's blood vessel, or a temperature or imaging sensor, or a combination sensor that measures multiple characteristics. For example, the flow data obtained by the flow sensor can be used to calculate physiological variables such as coronary flow reserve (CFR). The intravascular device 102 includes a flexible elongate member 106. The electronic components 112 are disposed at a distal portion 107 of the flexible elongate member 106. In some embodiments, the electronic components 112 can be attached to the distal portion 107 within a housing 280. The flexible tip coil 290 extends distally from the housing 280 at the distal portion 107 of the flexible elongate member 106. A connection portion 114 disposed at the proximal end of the flexible elongate member 106 includes conductive portions 132, 134. In some embodiments, the conductive portions 132, 134 can be conductive ink printed and / or deposited around the connection portion 114 of the flexible elongate member 106. In some embodiments, the conductive portions 132, 134 are conductive metal bands or rings disposed around the flexible elongate member. The locking region is formed by a collar or locking section 118, and the knob or retaining section 120 is disposed at the proximal portion 109 of the flexible elongate member 106.

[0017] The intravascular device 102 in Figure 1 includes a core wire having a distal core 210 and a proximal core 220. The distal core 210 and the proximal core 220 are metal components that form part of the body of the intravascular device 102. For example, the distal core 210 and the proximal core 220 may be flexible metal rods that provide a structure for the flexible elongated member 106. The distal core 210 and / or the proximal core 220 can be made of metal or a metal alloy. For example, the distal core 210 and / or the proximal core 220 can 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 the proximal core 220 are made of the same material. In other embodiments, the distal core 210 and the proximal core 220 are made of different materials. The diameters of the distal core 210 and the proximal core 220 can vary along their respective lengths. The junction between the distal core 210 and the proximal core 220 is surrounded and housed by a hypotube 215. The electronic component 112 may optionally be located at the distal end of the distal core 210.

[0018] In some embodiments, the intravascular device 102 has a distal subassembly and a proximal subassembly that are electrically and mechanically joined together to generate electrical communication between an electronic component 112 and conductive parts 132, 134. For example, flow data acquired 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. In some embodiments, the transducer element emits an ultrasonic signal, receives an echo, and generates an electrical signal representing the echo. A processing system 306 processes the electrical signal to extract the fluid velocity. In some embodiments, the electronic component is a pressure transducer (e.g., based on piezoresistive technology) that generates an electrical signal representing the pressure in the blood vessel. Signal carrier filers carry these electrical signals from the sensor at the distal part to the connector at the proximal part.

[0019] 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 and 134. The distal subassembly may include a distal core 210. The distal subassembly may also include the electronic component 112, a conductive member 230, and / or one or more layers of insulating polymer / plastic 240 surrounding the conductive member 230 and the core 210. For example, the polymer / plastic layer can insulate and protect the conductive member of a multifilar cable or conductor bundle 230. The proximal subassembly may include a proximal core 220. The proximal subassembly may include one or more polymer layers 250 (hereinafter, polymer layer 250) surrounding the proximal core 220 and / or a conductive ribbon 261 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 process of the intravascular device 102, the proximal and distal subassemblies can be joined together electrically and mechanically. As used herein, the flexible elongated member may refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220), and / or one or more components of the distal subassembly 410 (e.g., including the distal core 210). Thus, the flexible elongated member may refer to the combined proximal and distal subassemblies described above. The joint between the proximal core 220 and the distal core 210 is surrounded by a hypotube 215.

[0020] In various embodiments, the intravascular device 102 may include one, two, three, or more core wires extending along its length. For example, a single core wire may extend substantially along the entire length of the flexible elongated member 106. In such embodiments, the locking sections 118 and 120 may be integrally formed with the proximal portion of the single core wire. The electronic component 112 may be fixed to the distal portion of the single core wire. In other embodiments, such as the embodiment shown in Figure 1, the locking sections 118 and 120 may be integrally formed with the proximal portion of the proximal core 220. The electronic component 112 may be fixed to the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 (e.g., a multifilar conductor bundle or cable) that communicate with the electronic component 112. For example, the conductive members 230 may be one or more electrical wires that communicate directly with the electronic component 112. In some examples, the conductive member 230 is electrically and mechanically coupled to the electronic component 112, for example, by soldering. In some examples, the conductor bundle 230 has two or three electrical wires (e.g., a bifilar cable or a trifilar cable). Each electrical wire may include a bare metal conductor surrounded by one or more insulating layers. The conductive member 230 may extend along the length of the distal core 210. For example, at least a portion of the conductive member 230 may be spirally wrapped around the distal core 210 to minimize or eliminate whipping of the distal core in a winding anatomical structure.

[0021] The intravascular device 102 includes one or more conductive ribbons 261 in the proximal portion of a flexible elongated member 106. The conductive ribbons 261 are embedded within a polymer layer 250. The conductive ribbons 261 communicate directly with conductive portions 132 and / or 134. In some examples, the multifilar conductor bundle 230 is electrically and mechanically coupled to an electronic component 112, for example, by soldering. In some examples, the conductive portions 132 and / or 134 have conductive ink (e.g., metallic nanoink such as copper, silver, gold, or aluminum nanoink) deposited or printed onto the conductive ribbons 261.

[0022] As described herein, electrical communication between the conductive member 230 and the conductive ribbon 261 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 ribbon 261, the conductive portions 132 and 134 can communicate electrically with the electronic component 112.

[0023] In some embodiments shown in Figure 1, the intravascular device 102 includes a locking section 118 and a retaining section 120. To form the locking section 118, a machining process is used to remove the polymer layer 250 and conductive ribbon 261 in the locking section 118 and to shape the proximal core 220 in the locking section 118 into a desired shape. As shown in Figure 1, the locking section 118 has a reduced diameter, and the retaining section 120 has a diameter substantially similar to the diameter of the proximal core 220 at the connecting section 114. In some examples, since the machining process removes the conductive ribbon in the locking section 118, the proximal end of the conductive ribbon 261 is exposed to moisture and / or liquids such as blood, saline solution, disinfectant, and / or enzyme washing solution, and an insulating layer 158 is formed on the proximal end portion of the connecting section 114 to insulate the exposed conductive ribbon 261.

[0024] In some embodiments, the connector 314 provides an electrical connection between the conductive parts 132, 134 and the patient interface module (PIM) 304. The PIM 304 may optionally be connected to a console or processing system 306 that includes or communicates with a display 308.

[0025] System 100 may be located in a catheterization chamber having a control room. The processing system 306 may be located in the control room. Optionally, the processing system 306 may be located elsewhere, such as in the catheterization chamber itself. The catheterization chamber may include a sterile field, while its associated control room may be sterile or not, depending on the procedure to be performed and / or the medical facility. In some embodiments, the device 102 may be controlled from a remote location, such as a control room, so that the operator does not need to be in close proximity to the patient.

[0026] The intraluminal device 102, PIM 304, and display 308 may be communicatively coupled directly or indirectly to the processing system 306. These elements may be communicatively coupled to the medical processing system 306 via wired connections such as a standard copper multifilar conductor bundle 230. The processing system 306 may be communicatively coupled to one or more data networks, for example, a TCP / IP-based local area network (LAN). In other embodiments, different protocols such as a synchronous optical network (SONET) may be utilized. In some cases, the processing system 306 may be communicatively coupled to a wide area network (WAN).

[0027] The PIM 304 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 graphic, symbolic, or alphanumeric format). The console or processing system 306 may include a processor and memory. The processing system 306 may be operable to facilitate the mechanism of the intravascular sensing system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-temporary tangible computer-readable medium.

[0028] The PIM 304 facilitates signal communication between the processing system 306 and the in-tube device 102. The PIM 304 can be configured to communicate between the processing system 306 and the in-tube device 102. In some embodiments, the PIM 304 performs preliminary processing of data before relaying it to the processing system 306. In examples of such embodiments, the PIM 304 performs data amplification, filtering, and / or aggregation. In one embodiment, the PIM 304 also supplies high-voltage and low-voltage DC power to support the operation of the in-tube device 102 via the conductive member 230.

[0029] A multifilar cable or transmission line bundle 230 may include 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 straight sections 232 and 236 that lie parallel to the longitudinal axis of a flexible elongated member 106, and a helical section 234 that is wrapped around the outside of the flexible elongated member 106 and then overcoated with an insulating and / or protective polymer 240. Communication along the multifilar conductor bundle 230 may be via a number of methods or protocols, including serial, parallel, and others, with one or more filers in the bundle 230 carrying signals. One or more filers in the multifilar conductor bundle 230 may also carry direct current (DC) power, alternating current (AC) power, or function as a ground connection.

[0030] 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 show the user selectable prompts, instructions, and visualizations of imaging data. In some embodiments, the display 308 may be used to provide the user with a procedure-specific workflow for completing an intraluminal imaging procedure.

[0031] Before proceeding, please note that the above examples are provided for illustrative purposes only and are not intended to limit the scope of this description. Other devices and / or device configurations may be used to perform the operations described herein.

[0032] In some embodiments, the device 102 is positioned within or related to an anatomical object to acquire data. The anatomical object may include any anatomical structure or feature, such as the kidneys, liver, and / or other anatomical structures of the subject. This disclosure can be implemented in the context of any number of anatomical locations and tissue types, including, but not limited to, organs including the liver, kidneys, gallbladder, pancreas, and lungs, tubules, intestines, brain, dural sac, spinal cord, and peripheral nerves, the urinary tract, and intravascular valves, blood, abdominal organs, and / or other systems of the body. In some embodiments, the anatomical object may include malignant tumors such as tumors, cysts, lesions, hemorrhages, or blood pools within any part of an anatomical structure of the human body. The anatomical structure may be a blood vessel as an artery or vein of the vascular system of the object, including the cardiovascular system, peripheral vascular system, neurovascular system, renal vascular system, and / or any other suitable lumens in the body. In addition to natural structures, this disclosure may be implemented in the context of artificial structures such as heart valves, stents, shunts, filters, implants, and other devices, but is not limited to these.

[0033] Figure 2 is a schematic diagram of a processor circuit 210 according to an aspect of this disclosure. The processor circuit 210 may be implemented in the control system 130, intravascular system 101, or any other suitable location shown in Figure 1. In one example, the processor circuit 210 may communicate with an intravascular device 102 and a display 308 within the system 100. One or more processor circuits 210 are configured to perform the operations described herein. As shown, the processor circuit 210 may include a processor 260, a memory 264, and a communication module 268. These elements may communicate with each other directly or indirectly, for example, via one or more buses.

[0034] The processor 260 may include a CPU, GPU, DSP, application-specific integrated circuit (ASIC), controller, FPGA, other hardware device, firmware device, or any combination thereof configured to perform the operations described herein. The processor 260 may be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0035] Memory 264 may include cache memory (e.g., the cache memory of processor 260), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In embodiments, memory 264 includes non-temporary computer-readable media. Memory 264 may store instructions 266. Instructions 266 may include instructions that, when executed by processor 260, cause processor 260 to refer to probe 110 and / or host 130 and perform the operations described herein (Figure 1). Instructions 266 may be referred to as code. The terms “instruction” and “code” should be broadly interpreted 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.

[0036] The communication module 268 may include any electronic and / or logic circuits to facilitate direct or indirect communication of data between the processor circuit 210, the device 102, and / or the display 308. In this respect, the communication module 268 may be an input / output (I / O) device. In some examples, the communication module 268 facilitates direct or indirect communication between various elements of the processor circuit 210 and / or the device 102 (Figure 1) and / or the connector 314, PIM 304, processing system 306, and / or the display 308 (Figure 1).

[0037] Figure 3 is a perspective view of a sensor mount for an intravascular device according to an aspect of the present disclosure. The sensor mount 300 is designed with multiple layers that provide support and protection for the pressure sensor. For example, the sensor mount 300 can be manufactured using additive manufacturing such that layers of the sensor mount are built on top of other layers. Examples of sensor mounts and / or sensor housings (such as those manufactured by additive manufacturing, 3D printing, or semiconductor manufacturing technologies) can be found in U.S. Patent No. 10,932,678 to Burket, U.S. Patent No. 9,974,446 to Burket, U.S. Provisional Patent Application No. 63 / 328,355, filed on 7 April 2022 and titled “Multi-Component Housing for Sensor in Intraluminal Device” (Agent Case No. 2021PF00898 / 44755.2271PV01), and U.S. Provisional Patent Application No. 63 / 330,380, filed on 13 April 2022 and titled “Sensor Housing for Improved Accuracy and Electrical Reliability.” The sensor mount 300 may include multiple layers stacked on top of each other, including 2, 10, 15, 20, 50, 100, and / or other suitable larger and smaller values. Depending on the application, the layers of the sensor mount 300 may include any suitable material (metal, conductive, polymer, non-conductive, and / or a combination thereof). The sensor mount 300 may function to maintain the position of the sensor and prevent movement or damage that could affect its performance.

[0038] Sensors positioned on the sensor mount 300 can acquire intraluminal (e.g., intravascular) medical data related to the body cavity in which an intraluminal device (e.g., a catheter or guidewire) is placed. For example, pressure data acquired by a pressure sensor mounted on the sensor mount 300 can be used by a processor to calculate physiological values ​​such as the hyperechoic or non-hyperechoic pressure ratio (e.g., coronary flow reserve ratio or FFR, instantaneous flow reserve ratio or iFR, and / or any other distal pressure or Pd / Pa relative to proximal / aortic pressure). While embodiments of the sensor mount 300 are described in reference to the pressure sensor, it is understood that these embodiments can also be described in relation to flow sensors, temperature sensors, and / or other types of intravascular / intraluminal sensors.

[0039] The sensor mount 300 can be made of a variety of materials, including conductive and / or non-conductive materials. In some embodiments, conductive materials may provide conduction / transmission of electrical signals, electrical shielding, or electrical grounding. In some embodiments, non-conductive materials may provide electrical insulation. The type of material used will depend on the application and the specific requirements of the sensor.

[0040] The sensor mount includes a distal region 305 terminating at the distal end and a proximal region 307 terminating at the proximal end. In one or more layers, the channel 322 includes a layer 315 extending from the distal region 305 and forming an opening 316. In some embodiments, the opening 316 may be configured to receive the proximal end of a molded ribbon. The proximal end of the molded ribbon may be coupled to the sensor mount inside the opening 316. In some embodiments, the molded ribbon may extend distally from the sensor mount in the coil 290. The opening can be any suitable shape and size depending on the type and application of the sensor.

[0041] The proximal region 307 includes layers 312 and 318. Layer 318 may be located on the upper surface of layer 312. An opening 309 is formed within layers 312 and 318 in the proximal region 307. Multiple conductive pads are located within the opening 309. Conductive pads may be referred to by any appropriate term, such as bonding pads. The conductive pads may include any appropriate number of conductive pads. For example, the conductive pads may include two proximal conductive pads, conductive pad 370 and conductive pad 372, and three distal conductive pads, conductive pad 380, conductive pad 382, ​​and conductive pad 384. Conductive pads 370 and 372 may be made of palladium. Conductive pads 380, 382, ​​and 384 may similarly be made of palladium, but may also be made of a thin layer or plate of gold located on the upper surface of the palladium layer.

[0042] In some embodiments, the heights of the conductive pads 380, 382, ​​and 384 may be greater than those of the conductive pads 370 and 372. In some embodiments, the heights of the conductive pads 380, 382, ​​and 384 may be the same as the height of the layer 315. In some embodiments, the heights of the conductive pads 380, 382, ​​and 384 may be the same as the heights of the corresponding conductive pads of the sensor assembly coupled to the sensor mount 300.

[0043] The intermediate region may be located between the distal region 305 and the proximal region 307. This intermediate region may include a region 313 in which a pressure sensor assembly may be located. As shown in the figure, the sensor assembly located within region 313 may be cantilevered so as to be mechanically coupled to the illustrated layer 312. The portion of the sensor assembly that hangs over the edge of layer 312 may include a pressure sensor. In this orientation, the fluid can be allowed to surround the pressure sensor by being located between the lower surface of the pressure sensor and the upper surface of the sensor mount 300.

[0044] While aspects of this disclosure describe sensor mounts for lateral pressure sensors, in some embodiments, the sensor mounts may be for different types of sensors (e.g., flow sensors / ultrasonic transducers for Doppler signals, temperature sensors, etc.). In some embodiments, the sensor mounts may be for forward-facing sensors or backward-facing sensors. For example, the sensor mount may be for a forward-facing flow sensor / ultrasonic transducer for Doppler signals. In some embodiments, an intravascular guidewire or catheter may each include two sensor mounts for two different sensors (e.g., one sensor mount for a flow sensor and one sensor mount for a pressure sensor). In some embodiments, an intravascular guidewire or catheter may include one sensor mount for multiple different sensors (e.g., one sensor mount for both flow sensors and pressure sensors).

[0045] Figure 4A is a schematic diagram of a sensor assembly 340 coupled to a sensor mount 300 of an intravascular device according to an aspect of the present disclosure. As shown in Figure 4A, the sensor mount 340 is coupled to the sensor mount 300 at position 313 (Figure 3). The sensor assembly 340 may include a pressure sensor 350 and a number of conductive pads. In some embodiments, the sensor assembly may include a number of conductive pads equal to the number of distal conductive pads of the sensor mount 300. For example, as shown in Figure 4A, the sensor assembly may include three conductive pads, including conductive pads 390, 392, and 394. In some embodiments, the sensor 350 of the sensor assembly 340 may be electrically coupled to any or all of the conductive pads 390, 392, and / or 394.

[0046] In some embodiments, the sensor mount 300 and sensor assembly 340 may facilitate the transmission of electrical signals, including pressure measurement results or data, from the sensor 350 to the connector 314, PIM 304, processing system 306, and / or display 308 (Figure 1) in the illustrated configuration. For example, conductive pads 390 and 394 may be electrically connected to the positive and negative terminals of the sensor 340. Conductive pad 392 may be grounded. Wire bonds may electrically couple the sensor assembly 340 to the sensor mount 300. In particular, conductor 395 may be coupled to conductive pads 390 and 380. In this way, conductor 395 can electrically couple conductive pads 390 and 380. Similarly, conductor 396 may be coupled to conductive pads 392 and 382. In this way, conductor 396 can electrically couple conductive pads 392 and 382. Conductor 397 may be coupled to conductive pads 394 and 384. In this way, conductor 397 can electrically couple conductive pads 394 and conductive pad 384. The number of conductors 395, 396, 397, the number of conductive pads 390, 390, 392 (of sensor assembly 340), and / or the number of conductive pads 380, 382, ​​384 (of sensor mount 300) can be equal.

[0047] Examples of conductors 395, 396, and 397 include wire bonds or bond wires, filers, wires or wire segments, conductive traces, conductive inks, electrodes, etc. Conductors 395, 396, and 397 provide signal / data communication between conductive pads. For example, conductive pads and conductors 395, 396, and 397 can transmit sensor data acquired by a sensor to the proximal end of an intravascular guidewire (e.g., PIM 304 and / or processing system 306). For example, conductive pads and conductors 395, 396, and 397 can transmit control signals to a sensor in order to acquire sensor data from the proximal end of an intravascular guidewire (e.g., PIM 304 and / or processing system 306).

[0048] In some embodiments, conductive pad 380 may be electrically coupled to conductive pad 370. For example, as shown in more detail with reference to Figure 7A, conductive pad 370 may extend distally to form a layer of conductive pad 380. In this way, a positive signal (or possibly a negative signal) may be transmitted from conductive pad 380 to conductive pad 370. Similarly, conductive pad 384 may be electrically coupled to conductive pad 372. For example, as shown in more detail with reference to Figure 7A, conductive pad 372 may extend distally to form a layer of conductive pad 384. In this way, a positive signal (or possibly a negative signal) may be transmitted from conductive pad 384 to conductive pad 372.

[0049] The conductive pad 382 may be electrically coupled to the sensor mount 300 and may function as a ground. For example, as shown in more detail with reference to Figure 7A, the conductive pad 382 may extend downward and be mechanically and electrically coupled to the sensor mount 300. As shown with reference to Figure 8, this ground signal may be transmitted via solder to a distal core wire that is electrically communicating with a proximal core wire that is electrically communicating with the ground pad of connector 314 (Figure 1).

[0050] The conductive pad 370 may extend along the flexible elongated member of the intravascular device 102 and be electrically coupled (e.g., via solder) to a lead wire of a flexible conductor that electrically communicates with the corresponding conductive pad of the connector 314 (Figure 1). Similarly, the conductive pad 372 may extend along the flexible elongated member of the intravascular device 102 and be electrically coupled (e.g., via solder) to a lead wire of an additional flexible conductor that electrically communicates with the corresponding conductive pad of the connector 314 (Figure 1).

[0051] Additional embodiments of the conductive pads 370, 372, 380, 382, ​​and 384 are described with reference to Figure 4B.

[0052] Figure 4B is an enlarged schematic top view of the sensor mount 300 of the intravascular device 102 according to an aspect of the present disclosure. As shown in Figure 4B, layers 312 and 318 form a cavity 309 within the sensor mount 300. The dielectric filler 400 may be placed within the cavity 309. In some embodiments, as shown and described in more detail with reference to Figures 6A and 7A, the dielectric material may electrically insulate the pads 370, 372, 380, and 384 from the sensor mount 300. As previously described, the conductive pad 382 is electrically coupled to the sensor mount 300. Therefore, the dielectric material 400 does not insulate the pad 382 from the sensor mount 300. In some embodiments, the material 400 may be any suitable non-conductive material.

[0053] Figure 5 is a schematic diagram of the signal path 500 of the intravascular sensing system 100 according to an aspect of the present disclosure. As shown in Figure 5, the pressure sensor assembly 340 includes conductive pads 390, 392, and 394. The pressure sensor mount 300 includes three conductive pads 380, 384, and 382. The conductive pads 380, 384, and 382 may be gold layers bonded to a palladium layer. For example, conductive pad 380 may be laminated on the upper surface of a palladium layer, which may be conductive pad 370 or electrically coupled to conductive pad 370; conductive pad 384 may be laminated on the upper surface of a palladium layer, which may be conductive pad 372 or electrically coupled to conductive pad 372; and conductive pad 382 may be laminated on the upper surface of a palladium layer 772 (Figure 7B). The conductive pads 390, 394, and 392 may communicate electrically with the conductive pads 380, 384, and 382 via one or more wire bonds 510. In some embodiments, the wire bonds 510 may be substantially similar to the wire bonds 395, 396, and 397 shown and described with reference to Figure 4A.

[0054] In some embodiments, the sensor mount 300 includes conductive pads 370 and / or 372 (which may constitute one set of conductive pads) and conductive pads 380, 382, ​​and / or 384 (which may constitute another set of conductive pads). In some embodiments, the sensor mount may not include conductive pads 370 and / or 372, but may include only conductive pads 380, 382, ​​and / or 384. In some embodiments, the sensor mount may not include conductive pads 380, 382, ​​and / or 384, but may include only conductive pads 370 and / or 372.

[0055] In embodiments where conductive pads 370 and / or 372 are omitted from the sensor mount, the distal ends of the conductors (e.g., conductor 230 in Figure 1, or 522 and 524 in Figure 5) may be directly coupled mechanically and electrically to conductive pads 380 and / or 384. In some embodiments, conductive pads 380 and / or 384 may extend further proximal to provide more space for coupling the distal ends of the conductors. In this regard, conductive pads 380 and / or 384 may be coupled to both the distal ends of the conductors and the proximal ends of the wire bonds 395, 396 and / or 397 (Figure 4A). When conductive pads 370 and / or 372 are omitted (compared to, for example, Figures 7A and 7B), the total number of layers stacked on top of each other can be reduced.

[0056] Alternatively, in embodiments where conductive pads 380, 382, ​​and / or 384 are omitted from the sensor mount, the total number of layers may be reduced. In such embodiments, the distal ends of conductors (e.g., conductor 230 in Figure 1, and / or conductors 522 and 524 in Figure 5) may be directly coupled mechanically and electrically to conductive pads 370 and / or 372. Conductive pads 370 and / or 372 may be coupled to both the distal ends of conductors (e.g., conductor 230 in Figure 1, and / or 522 and 524 in Figure 5) and the proximal ends of wire bonds 395, 396, and / or 397. In such embodiments, the total number of layers may be reduced if conductive pads 370 and / or 372 are omitted (e.g., compared to Figures 7A and 7B). For example, in some embodiments, any of layers 771, 770, and 380 (Figure 7A / 7B), layers 776, 775, and 384 (Figure 7A / 7B), and / or layers 774, 773, and 382 (Figure 7A / 7B) may be omitted.

[0057] In some embodiments, conductive pads 380, 384, and 382 and conductive pads 390, 394, and 392 may be made of gold. Similarly, wire bonds 395, 396, and 397 may be made of gold. In some embodiments, conductive pads 380, 384, and 382, ​​as well as conductive pads 390, 394, and 392 and wire bonds 395, 396, and 397, may all be formed of different materials. In some embodiments, conductive pads 380, 384, and 382 and conductive pads 390, 394, and 392 and wire bonds 395, 396, and 397, each formed of the same material, may advantageously increase the bonding strength of conductive pads 390, 394, and 392 and wire bonds 395, 396, and 397. In some embodiments, this also allows wire bonds 395, 396, and 397 to be formed by machine between conductive pads 390, 394, and 392 and wire bonds 395, 396, and 397, enabling the process to be automated rather than performed manually, which may lead to improved reliability, reduced error rates, and reduced manufacturing costs and time.

[0058] As shown in box 511 of Figure 5, the conductive pads 380, 370, 384, and 372 may be electrically insulated from the pressure sensor mount (for example, by the dielectric material 400 shown in Figure 4B). However, the conductive pad 382 may also be electrically communicating with the sensor mount 300 itself, at least through layer 772, allowing electrical signals to pass through the sensor mount 300 as shown in line 512.

[0059] As shown in Figure 5, the conductive pad 370 electrically communicates with the corresponding pad 550 of the connector 540 (e.g., connector 314 in Figure 1) via a conductor 522 extending along the flexible elongated member. The conductive pad 372 electrically communicates with the corresponding pad 550 of the connector 540 (e.g., connector 314 in Figure 1) via a conductor 524 extending along the flexible elongated member. Pad 382, ​​which transmits the ground signal, electrically communicates with layer 772, which is electrically communicating with the sensor mount 300. The signal may also pass from the sensor mount 300, through solder 800, and through the distal core wire 810, as shown in lines 514 and 516. The distal core wire 810 electrically communicates with the proximal core wire 830, which is electrically communicating with the corresponding pad 550 of the connector 540, as shown in lines 518 and 520. In this way, the ground signal communicates electrically with the corresponding ground pad at the connection 540. As a result, the number of conductors (e.g., conductors 522 and 524) within the flexible elongated member may be reduced by using existing distal and proximal core wires on which pads 392 and 382 are installed.

[0060] Figure 6A is a cross-sectional perspective view of a sensor mount 300 according to an aspect of the present disclosure. As shown in Figure 6A, the opening 309 includes a dielectric filer 400. Furthermore, the dielectric filer 400 is positioned beneath the conductive pads 370 and 372. In other words, the dielectric filer 400 is positioned between the conductive pads 370 and 372 and the sensor mount 300 itself. Because the dielectric filer 400 is non-conductive, the conductive pads 370 and 372 are electrically isolated from the sensor mount 300.

[0061] Figure 6A also shows layers 672 and 670 positioned beneath pads 372 and 370, respectively. In some embodiments, these layers 672 and 670 may be made of conductive or non-conductive material and may provide structural support for pads 370 and 372. For example, layers 672 and 670 may extend to the dielectric filer 400 to increase the structural strength of pads 372 and 370 and layers 670 and 672, while remaining in contact with the body of the sensor mount 300 to maintain electrical insulation.

[0062] Figure 6B is a cross-sectional side view of a sensor mount according to an aspect of the present disclosure. Figure 6B shows a more detailed view of the various layers forming the sensor mount 300. For example, layer 319 may be located between layers 312 and 318. Layer 312 and the dielectric filer 400 may be located on top of layer 610. Layers 612, 614, 616, 618, and 620 are also depicted. In some embodiments, layers 612, 614, 616, 618, and 620 may form a channel 622 extending along the longitudinal length of the sensor mount 300. Core wires, such as a distal core wire, may be placed within the channel 622 during assembly, as will be described in more detail with reference to Figure 8.

[0063] Figure 6B further shows pads 372 and 370, respectively, positioned on layers 672 and 670. In some embodiments, as illustrated, layers 672 and 670 may be positioned on layers 676 and 674, respectively. In some embodiments, these layers 676 and 674 may extend into a portion of the filler 400 to increase structural support.

[0064] Figure 7A is a cross-sectional perspective view of a sensor mount 300 according to an aspect of the present disclosure. As shown in Figure 7A, the conductive pad 370 may extend distally and form a layer of conductive pad 380, and the conductive pad 372 may extend distally and form a layer of conductive pad 384. For example, the conductive pad 380 may be laminated on a palladium layer 770, which is laminated on an additional palladium layer 771 located in the distal region of the conductive pad 370. The conductive pad 384 may similarly be laminated on a palladium layer 775, which is laminated on an additional palladium layer 776 located in the distal region of the conductive pad 372. In this regard, the conductive pad 370 may communicate electrically with the conductive pad 380. The conductive pad 372 may communicate electrically with the conductive pad 384.

[0065] Figure 7A further shows a conductive pad 382. The conductive pad 382 may be similar to conductive pads 380 and 384 in that the conductive pad 382 may be composed of the same or similar material. In some embodiments, the conductive pad 382 may be composed of gold. The conductive pad 382 is placed on a plurality of palladium layers, which will be described in more detail below with reference to Figure 7B.

[0066] Figure 7A also shows how the central conductive pad 382 is electrically coupled to ground by being connected to the sensor mount 300 itself beneath the central pad 382, ​​as will be described in more detail with reference to Figure 7B. The sensor mount is electrically and mechanically coupled to a core wire that extends along a flexible elongated member to the ground connection within a channel 622, for example, as illustrated and described with reference to Figure 6B.

[0067] Figure 7B is a cross-sectional side view of the sensor mount 300 according to the present disclosure. In some embodiments, the cross-sectional side view shown in Figure 7B may be similar to the cross-sectional side view shown in Figure 6B, but may be located at a more distal position than the position shown in Figure 6B, as described earlier in Figure 4A.

[0068] Figure 7B shows multiple layers associated with conductive pads 384, 382, ​​and 380, respectively. For example, conductive pad 384 may be laminated on a set of layers including layer 775, layer 776, and a portion of the aforementioned conductive pad 372. In some embodiments, layers 775 and 776, and conductive pad 372 may be made of palladium. Conductive pad 372 is located on layer 794, and layer 794 is located on layer 795. In some embodiments, layers 794 and 795 may be made of the same material as the sensor mount 300. In some embodiments, layers 794 and 795 may be conductive layers. Layer 795 is shown located on a dielectric filler material 400. In this respect, the layers associated with conductive pad 384 may be electrically insulated from the sensor mount 300. In some embodiments, layer 795 may extend alternately into the dielectric filler material 400 to enhance the structural stability of the conductive layer.

[0069] Similarly, the conductive pad 380 may be laminated on a set of layers including layer 770, layer 771, and a portion of the aforementioned conductive pad 370. In some embodiments, layers 770, 771, and 370 may be composed of palladium. The conductive pad 370 is placed on layer 790, and layer 790 is placed on layer 791. In some embodiments, layers 790 and 791 may be composed of the same material as the sensor mount 300. In some embodiments, layers 790 and 791 may be conductive layers. Layer 791 is shown placed on a dielectric filler material 400. In this respect, the layers associated with the conductive pad 380 may be electrically insulated from the sensor mount 300. In some embodiments, layer 791 may extend alternately into the dielectric filler material 400 to enhance the structural stability of the conductor.

[0070] The conductive pad 382 is placed on layer 772, which is placed on layer 773. Layer 773 is placed on layer 774. Each of layers 772, 773, and 774 may be a conductive layer. For example, layers 772, 773, and 774 may be made of palladium. In some embodiments, layer 774 is placed on layer 792, which is placed on layer 793. Layers 792 and 793 may be made of the same material as the sensor mount 300. In some embodiments, layer 793 is placed on layer 402. Layer 402 may be a layer of the sensor mount 300 and is placed on the aforementioned layer 610. In this respect, the conductive pad 382 electrically communicates with the sensor mount 300 via a stack of layers beneath the conductive pad 382, ​​including layers 772, 773, 774, 792, 793, and 402. As illustrated and described in more detail with reference to Figure 8, the sensor mount 300, and by extension, the conductive pad 382, ​​may extend along a flexible elongated member and electrically communicate with a distal core wire connected to a ground source.

[0071] Figure 8 is a cross-sectional side view of an intravascular device 102 according to an aspect of the present disclosure. The cross-sectional side view shown in Figure 8 may correspond to the same position as the cross-sectional side view in Figure 7B, but the cross-sectional side view shown in Figure 8 includes additional components of the device 102, including solder 800, distal core wire 810, and housing 880. The cross-sectional side view shown in Figure 8 may show a view of the device 102 at a stage of assembly or after assembly. As illustrated, during assembly, the channel 622 (Figures 6B, 7B) may be filled with solder 800 or other suitable conductive material. The distal core wire 810 may then be placed within the channel 622 such that the distal core wire 810 is coupled to the sensor mount 300 within the channel 622 via solder 800. This process brings electrical and mechanical communication between the distal core wire 810 and the sensor mount 300. After the distal core wire 810 is positioned within the channel 622 and coupled to the sensor mount 300, the housing 880 may be positioned around the assembly. This may be done by sliding the housing 880 onto the assembly from the distal end, or by any other suitable method. In some embodiments, as shown in Figure 5 and previously described, the distal core wire 810 may be electrically and mechanically coupled to a proximal core wire that is connected to a connection in the system.

[0072] Figure 9A is a top view of the housing 880A of the intravascular device 102 according to an aspect of the present disclosure. As shown, the housing 880A may be a cylindrical portion including a central lumen in which the assembly of the sensor mount 300 and the core wire 810 (Figure 8) may be housed. The housing 880A may include an opening 812A. The opening 812A may be sized and shaped so that various components attached to the sensor mount 300 are exposed to the surrounding environment. For example, the opening 812A may be sized and shaped so that the sensor 350, conductive pads 390, 392, and 394, conductive pads 380, 382, ​​and 384, and conductive pads 370 and 372 (Figure 4A) are exposed to the surrounding environment. Thus, the opening 812A may allow a fluid from the environment, such as blood, to come into contact with the sensor 350 and / or any suitable film placed around the sensor 350, and so that the sensor 350 may acquire fluid pressure data. The exposed conductive pads may allow for additional assembly after the housing 880A has been installed. For example, wire bonds 395, 396, and / or 397 may be created by machine or manually after the housing 880A has been positioned around the assembly. In this regard, the width 890 may be an appropriate width to allow each of these components to be exposed.

[0073] Figure 9B is a top view of the housing 880B of the intravascular device 102 according to an aspect of the present disclosure. In some embodiments, the housing 880B may be similar to the housing 880A described above. For example, the housing 880B may be a cylindrical portion including a central lumen in which the assembly of the sensor mount 300 and the core wire 810 (Figure 8) may be located. The housing 880B may also include an opening 812B. However, the shape of the opening 812B may differ from that of the opening 812A described above. In particular, the opening 812B may include a proximal region 814B with a width 892. The width 892 may be greater than the width 890, as shown in Figure 9B. The increased width 892 of region 814B may provide increased space for tool access during assembly. For example, the increased space provided by the increased width 892 may advantageously allow an automated machine to access the area of ​​the sensor mount 300 near the proximal region 814B to mount or assemble various components. For example, an automated machine may produce wire bonds 395, 396, and / or 397 (Figure 4A) by positioning the appropriate tools through area 814B. The additional space provided by the wider opening 814B provides more space for the wire bonding process. In some embodiments, the size of the wire bonding tip of the automated machine may be greater than the width 890. In that respect, a larger section of 814B can accommodate the tip.

[0074] Figure 9C is a top view of the housing 880C of the intravascular device 102 according to an aspect of the present disclosure. In some embodiments, the housing 880C may be similar to the housings 880A and / or 880B described above. For example, the housing 880C may be a cylindrical portion including a central lumen in which the assembly of the sensor mount 300 and the core wire 810 (Figure 8) may be placed. The housing 880C may include an opening 812C substantially similar to the proximal opening 814B described with reference to Figure 9B. For example, the region 814C may have a width of 892. However, the housing 880C may further include a distal region 816C. The region 816C may have a width of 894. In some embodiments, the width 894 may be substantially similar to the width 892. In some embodiments, the width 894 may be the same as the width 892. In some embodiments, the width 894 may be greater than or less than the width 892.

[0075] The increased width of the distal region 816C may favorably allow trapped air within the housing 880C to escape during assembly of the device 102. By allowing air to escape from the housing 880C, the structural integrity of the device 102 may be increased. This makes the device 102 more reliable and able to withstand the various forces applied to the device 102 during intravascular measurement procedures. In some embodiments, the length of the opening 812C may be the same width. In some embodiments, the width 890 may be selected to be smaller than the widths 892 and 894 to provide additional protection to the pressure sensor (e.g., sensor 350 in Figure 4A).

[0076] Figure 10A is a top view of the sensor assembly 340 and housing 880B of an intravascular device 102 according to an aspect of the present disclosure. For example, the view shown in Figure 10A may be of the device 102 after complete assembly. For example, the sensor mount 300 is located within the housing 880B. As shown, the opening 812B may be aligned with the sensor mount so as to expose the sensor 340 of the sensor assembly 340 and the conductive pads 390, 392, 394, 380, 382, ​​384, 370, and 372. Furthermore, the sensor mount 300 may be positioned relative to the housing 880B such that the conductive pads are located close to a proximal region 814B with increased width, allowing increased access to mechanical tools to perform additional assembly steps.

[0077] Figure 10B is a top view of the sensor assembly 350 and housing 880C of the intravascular device 102 according to an aspect of the present disclosure. For example, the view shown in Figure 10B may be of the device 102 after complete assembly. For example, the sensor mount 300 is located within the housing 880C. As shown, the opening 812C may be aligned with the sensor mount so as to expose the sensor 350 of the sensor assembly 340 and the conductive pads 390, 392, 394, 380, 382, ​​384, 370, and 372. Furthermore, the sensor mount 300 may be positioned relative to the housing 880C such that the conductive pads are located close to an increased-width region 814C, allowing increased access to mechanical tools to perform additional assembly steps. The distal region 816C may be located near the distal region of the sensor assembly 340 to facilitate the escape of trapped air in or near that region.

[0078] Figure 11 is a flowchart of a method 1100 for assembling an intravascular device 102 according to an aspect of the present disclosure. As shown, the method 1100 includes a number of enumerated steps, although aspects of the method 1100 may include additional steps before, after, or between the enumerated steps. In some aspects, one or more of the enumerated steps may be omitted, performed in a different order, or performed simultaneously. The steps of the method 1100 can be performed by any suitable component in the system 100, and not all steps need to be performed by the same component. In some aspects, one or more steps of the method 1100 can be performed by a processor circuit, including, for example, a processor 210, or at its direction.

[0079] In step 1110, method 1100 includes coupling the sensor assembly to the sensor mount. In some embodiments, step 1110 may be performed by an automated machine. In some embodiments, step 1110 may be performed via a pick-and-place process. Step 1110 may be performed by an automated machine. The process of coupling the sensor assembly to the sensor mount can be carried out using equipment specifically designed for this purpose. Such equipment may include a machine that uses an adhesive dispenser, a heat source, or other special tools to couple the sensor assembly to the mount. In other cases, step 1110 may be carried out via a pick-and-place process. This means that the sensor assembly is moved and positioned using a machine that can pick up the sensor assembly and place it precisely where it is needed on the sensor mount.

[0080] In step 1120, method 1100 includes coupling the distal core wire to the sensor mount. The distal core wire may be coupled to the sensor mount in any suitable way. For example, the distal core wire may be coupled to the sensor mount via solder. The distal core wire functions to transmit signals, such as a ground signal, from the sensor element to other components or processing units in the device or system. Multiple techniques or methods may be used to mount the wire depending on the specific requirements of the device or system being constructed. Some examples of coupling methods may include soldering, welding, and adhesive bonding. The distal core wire may be securely attached to the mount to ensure reliable signal transmission.

[0081] In step 1130, method 1100 includes positioning a housing around the sensor assembly and sensor mount. The housing may include any suitable type of housing, such as housing 880 described herein. The housing may be positioned in a suitable manner around the sensor assembly and sensor mount. For example, the housing may be a snap-on housing designed to fit snugly around the sensor mount and assembly and held in place by snapping onto the mount. In some embodiments, the housing may be positioned via fasteners such as screws, adhesives, or other processes such as overmolding.

[0082] In step 1140, method 1100 includes forming wire bonding between conductive pads. For example, step 1140 may include forming a wire bond 395 between conductive pads 390 of sensor assembly 340, forming a wire bond 396 between conductive pad 392 and conductive pad 382, ​​and forming a wire bond 397 between conductive pad 394 and conductive pad 384.

[0083] Those skilled in the art will understand that the apparatus, systems, and methods described above can be modified in various ways. Accordingly, those skilled in the art will understand that the embodiments contained herein are not limited to the specific exemplary embodiments described above. In this regard, while exemplary embodiments have been illustrated and described, a wide range of variations, alterations, and substitutions are contemplated in the foregoing disclosure. Such variations are understood to be made to those described above without departing from the scope of the foregoing disclosure. Accordingly, it is appropriate that the appended claims be interpreted broadly in a manner consistent with the foregoing disclosure.

Claims

1. A flexible, elongated member configured to be placed inside the patient's body cavity, A sensor mount having a plurality of first conductive pads is disposed at the distal end of the flexible elongated member, A sensor assembly disposed on the aforementioned sensor mount, A sensor configured to acquire intraluminal medical data related to the body cavity, and A second plurality of conductive pads electrically coupled to the first plurality of conductive pads, A sensor assembly having, An intraluminal device having

2. The intratubular device according to claim 1, wherein the number of the second plurality of conductive pads is equal to the number of the first plurality of conductive pads.

3. The intratubular device according to claim 1, wherein the sensor mount further comprises a third plurality of conductive pads.

4. The intraluminal device according to claim 3, wherein the third plurality of conductive pads include a first conductive pad, a second conductive pad, and a third conductive pad.

5. The intratubular device according to claim 4, wherein a portion of one of the first plurality of conductive pads forms a layer of the first conductive pad of the third plurality of conductive pads.

6. The intratubular device according to claim 3, wherein a portion of one of the first plurality of conductive pads forms a layer of the third plurality of conductive pads.

7. The intratubular device according to claim 3, wherein the second conductive pad among the third plurality of conductive pads is electrically coupled to a ground.

8. The intraluminal device according to claim 1, wherein the first plurality of conductive pads are arranged within the cavity of the sensor mount.

9. The intraluminal device according to claim 8, wherein the dielectric filler is disposed within the cavity of the sensor mount.

10. The intratubular device according to claim 9, wherein the dielectric filler electrically insulates the first plurality of conductive pads from the sensor mount.

11. The intraluminal device according to claim 1, wherein the first plurality of conductive pads include three conductive pads.

12. The intratubular device according to claim 11, wherein two of the first plurality of conductive pads are electrically coupled to corresponding cables extending along the flexible elongated member.

13. The intratubular device according to claim 1, wherein the sensor assembly is configured to be mechanically bonded to the sensor mount via an adhesive.

14. The intravascular device according to claim 1, wherein the sensor mount is located within the housing.

15. The intravascular device according to claim 1, wherein the housing includes an opening having a proximal end and a distal end positioned adjacent to the first plurality of conductive pads of the sensor mount.

16. The intravascular device according to claim 15, wherein the width of the proximal end of the opening is wider than the width of the central portion of the opening.

17. An intravascular guidewire configured to be placed inside a blood vessel, In a device having, The aforementioned intravascular guidewire is A first set of multiple conductive pads, and A second plurality of conductive pads positioned distal to the first plurality of conductive pads, A sensor mount having, An intravascular pressure sensor having a third plurality of conductive pads arranged on the sensor mount and electrically coupled to the second plurality of conductive pads, It has, The first plurality of conductive pads are electrically coupled to a plurality of corresponding conductors extending along the length of the intravascular guidewire. Device.

18. The apparatus according to claim 17, wherein the number of the second plurality of conductive pads is greater than the number of the first plurality of conductive pads.

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