Sensor mount with embedded conductors for different sensors

Abstract

The invention provides an intraluminal device. The endoluminal device includes a flexible elongate member positionable within a body lumen of a patient. A sensor mount, a first sensor, and a second sensor are positioned at a distal portion of the flexible elongate member. The first sensor is positioned on the sensor mount. The second sensor is spaced apart from the first sensor. The sensor mount includes a conductive material configured to transmit a signal associated with the second sensor.

Description

Technical Field

[0001] The subject matter described herein relates to intraluminal physiological sensing devices (e.g., intravascular pressure sensing and / or flow sensing guidewires). For example, an intraluminal device may include a sensor mount that supports a sensor and has embedded conductive pathways for transmitting electrical signals to and from different sensors. Background Art

[0002] Existing intravascular guidewires with sensors have thin gauge wires that provide electrical signal transmission for the sensors. These guidewires are small and have a small diameter in order to fit inside small blood vessels. In addition, the core wire and wires occupy separate spaces within the guidewire, and routing the wires through the sensor mount of one sensor toward a more distal second sensor presents design and manufacturing challenges.

[0003] The information contained in the background section of this specification (including any documents cited herein and any description or discussion thereof) is included for technical reference purposes only and should not be regarded as subject matter by which the scope of the present disclosure is limited. Summary of the invention

[0004] The present invention discloses an intraluminal physiological sensing device (e.g., an intravascular pressure sensing and / or flow sensing guidewire), which includes a sensor mount with an embedded conductive channel. The present application relates to a multi-sensor intraluminal physiological sensing device (e.g., a device including two pressure sensors, two flow sensors, a pressure sensor and a flow sensor, etc.). This may also be referred to as a combined or combined intraluminal physiological sensing device. The sensor mount of one of the sensors includes a conductive material that transmits a signal for another sensor. That is, the sensor mount that physically supports one of the sensors has a conductive material and also transmits a signal for a different sensor. The different sensors can be, for example, sensors that are not supported by the sensor mount, or sensors that are spaced apart from the sensor mount (e.g., on its distal side, proximal side), or sensors that are disposed on different (e.g., more distal, more proximal) parts of the sensor mount. The embedded conductive channel allows a microwire or wire located proximal to the sensor mount to be connected to a component located distal to the sensor mount (e.g., another sensor) without having to extend the wire beside the sensor mount and directly to the distal component. This arrangement can significantly simplify the assembly of the guide wire device, thereby reducing costs and the possibility of manufacturing defects, while also improving the robustness of the guide wire during operation and use. In addition, this arrangement can reduce or eliminate the need to position the wire between the sensor mount and the sensor housing surrounding the sensor mount. Generally speaking, the sensor mount can physically support a sensor or multiple sensors, and the sensor mount can include a conductive path to transmit signals associated with a sensor and / or multiple sensors.

[0005] The sensor mount with embedded conductor disclosed herein has specific but not exclusive utility for intraluminal medical catheters, guidewires or guide catheters. One general aspect includes an intraluminal device. The intraluminal device includes: a flexible, slender member configured to be positioned within a body lumen of a patient, wherein the flexible, slender member includes a proximal portion and a distal portion; a first sensor positioned at the distal portion of the flexible, slender member; a second sensor positioned at the distal portion of the flexible, slender member; and a sensor mount positioned at the distal portion of the flexible, slender member, wherein the first sensor is positioned on the sensor mount. The second sensor is spaced apart from the first sensor, and the sensor mount includes a first material that is conductive and configured to transmit an electrical signal associated with the second sensor.

[0006] Implementations may include one or more of the following features. In some embodiments, the first sensor includes a first intraluminal mode and the second sensor includes a second, different intraluminal mode. In some embodiments, the first sensor includes a pressure sensor and the second sensor includes a flow sensor. In some embodiments, the sensor mount includes a second material that forms an outer surface of the sensor mount, wherein, in cross-section, the second material completely surrounds the conductive first material. In some embodiments, the second material is conductive, the sensor mount includes a third material that is disposed between the first material and the second material, and the third material includes an electrically insulating material. In some embodiments, in cross-section, the third material completely surrounds the first material. In some embodiments, the sensor mount includes a proximal portion and a distal portion, and the first material extends between the proximal portion and the distal portion. In some embodiments, the first sensor overlaps the first material along the length of the sensor mount. In some embodiments, a majority of the first material is embedded within the sensor mount, and the first material includes a first exposed portion and a second exposed portion. In some embodiments, the intraluminal device further comprises: a connector region positioned at a proximal portion of the flexible elongated member; a first wire coupled to the first exposed portion and the second sensor; and a second wire coupled to the second exposed portion and the connector region such that the second sensor is electrically connected to the connector region. In some embodiments, the intraluminal device further comprises: a connector region positioned at a proximal portion of the flexible elongated member; a first wire coupled to the first exposed portion and the second sensor; a wire bond coupled to the second exposed portion and the first sensor; and a second wire coupled to the first sensor and the connector region such that the first sensor and the second sensor are electrically connected to the connector region. In some embodiments, the intraluminal device further comprises a third wire coupled to the first sensor and the connector region such that the first sensor is electrically connected to the connector region. In some embodiments, the first exposed portion and the second exposed portion are continuous with an outer surface of the sensor mount. Implementations of the technology may include hardware, methods or processes or computer software on a computer accessible medium.

[0007] A general aspect includes a device. The device includes: an intravascular guidewire configured to be positioned within a patient's blood vessel; a flow sensor positioned at a distal end of the intravascular guidewire; a pressure sensor positioned proximal to the flow sensor such that the pressure sensor is spaced apart from the distal end of the intravascular guidewire; a pressure sensor mount, wherein the pressure sensor is positioned on the pressure sensor mount; a connector region positioned at a proximal portion of the intravascular guidewire; and a flow signal path extending between the flow sensor and the connector region, wherein the flow signal path is configured to transmit an electrical signal associated with the flow sensor, wherein a portion of the flow signal path includes a conductive material that forms a portion of the structure of the pressure sensor mount. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each of which is configured to perform the actions of the method.

[0008] Implementations may include a device, the device also including: a pressure signal path extending between the pressure sensor and the connector area, and the pressure signal path is configured to transmit an electrical signal associated with the pressure sensor. Implementations of the technology may include hardware, methods or processes, or computer software on a computer-accessible medium.

[0009] This Summary introduces selected concepts in a simplified form that are further described in the Detailed Description below. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive introduction to the features, details, utilities, and advantages of a sensor mount with embedded conductors, as defined in the claims, will be provided in the following written description of various aspects of the disclosure and illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, in which:

[0011] Figure 1 is a schematic top view of an intravascular device according to aspects of the present disclosure.

[0012] Figure 2 is a schematic side view of an intravascular sensing system including an intravascular device according to aspects of the present disclosure.

[0013] Figure 3 is a schematic cross-sectional view of an example sensor assembly according to aspects of the present disclosure, which sensor assembly may be included in Figure 2 intravascular devices.

[0014] Figure 4 is a schematic cross-sectional view of an intraluminal sensing device including both a pressure sensor and a flow sensor according to aspects of the present disclosure.

[0015] Figure 5 is a schematic cross-sectional side view of a sensor mount having embedded signal transmitting conductive material according to aspects of the present disclosure.

[0016] Figure 6 is a schematic cross-sectional view of a detail area of ​​a sensor mount having embedded signal transmitting conductive material according to aspects of the present disclosure.

[0017] Figure 7 is a schematic top view of a sensor mount with embedded signal transmitting conductive material according to aspects of the present disclosure.

[0018] Figure 8 is a schematic cross-sectional view of a detail area of ​​an example sensor mount according to aspects of the present disclosure.

[0019] Fig. 9 is a wiring diagram of an intraluminal sensing device including both a pressure sensor and a flow sensor according to aspects of the present disclosure.

[0020] Fig.10 is a sensor mount according to various aspects of the present disclosure (its schematic wiring diagram is shown in Fig. 9 Schematic perspective view of the ).

[0021] Fig.11 According to various aspects of the present disclosure Fig.10 Schematic top view of a sensor mount.

[0022] Fig.12 is taken along cross-sectional line 12-12 according to various aspects of the present disclosure Fig.11 Schematic side cross-sectional view of a sensor mount.

[0023] Fig.13 is a wiring diagram of an intraluminal sensing device including both a pressure sensor and a flow sensor according to aspects of the present disclosure.

[0024] Fig.14 is a sensor mount according to various aspects of the present disclosure (its schematic wiring diagram is shown in Fig.13 Schematic perspective view of the ).

[0025] Fig.15 According to various aspects of the present disclosure Fig.14 Schematic perspective view of a detail area of ​​the sensor mount.

[0026] Fig.16 According to various aspects of the present disclosure Fig.14 Schematic top view of a detail area of ​​the sensor mount.

[0027] Fig.17 is a schematic diagram of a processor circuit according to at least one embodiment of the present disclosure. DETAILED DESCRIPTION

[0028] The present application discloses an intraluminal physiological sensing device (e.g., an intravascular pressure sensing and / or flow sensing guidewire or catheter) comprising a sensor mount having an embedded conductive channel. The present application relates to a multi-sensor intraluminal physiological sensing device or a combined intraluminal physiological sensing device (e.g., a device comprising two pressure sensors, two flow sensors, one pressure sensor and one flow sensor, etc.). The sensor mount for a first sensor includes a conductive material that transmits a signal for another sensor. That is, the sensor mount that physically supports the first sensor has a conductive material and also transmits a signal for a different sensor (e.g., a sensor that is not supported by the sensor mount or is spaced apart from the sensor mount and / or the first sensor).

[0029] The embedded conductive channel allows the microwire or wire located on the proximal side of the sensor mount to be electrically connected to a component (e.g., another sensor, such as a flow sensor) disposed on the distal side of the sensor mount without extending the wire next to the sensor mount and directly extending to the distal component. This arrangement can significantly simplify the design and assembly process of the guide wire device. This simplification can reduce the cost and the possibility of manufacturing defects, while also improving the robustness of the intraluminal sensing device during manipulation and use. In addition, this arrangement can reduce or eliminate the need to position the wire between the sensor mount and the sensor housing surrounding the sensor mount. This in turn can allow a tighter fit between the sensor mount and the sensor housing, or allow a larger sensor mount or a smaller sensor housing. A smaller sensor housing may be advantageous, for example, allowing a smaller outer diameter of the intraluminal sensing device. In some embodiments, this arrangement can even allow the sensor mount and the sensor housing to be combined into a single component, thereby further simplifying the design and manufacturing / assembly process.

[0030] Example devices containing multifilament conductor bundles and / or conductive ribbons include intraluminal medical guidewire devices, such as described in U.S. Patent No. 10,595,820B2, U.S. Patent Publication Nos. 2014 / 0187874, 2016 / 0058977, and 2015 / 0273187, and U.S. Provisional Patent Application No. 62 / 552,993 filed on August 31, 2017, each of which is incorporated herein by reference in its entirety as if fully set forth herein. Example devices containing both pressure sensors and flow sensors can be found, for example, in U.S. Patent No. 8,231,537, which is hereby incorporated herein by reference in its entirety as if fully set forth herein. Examples of flow sensor housings can be found, for example, in U.S. Provisional Patent Application No. 63 / 328,255 (Atty Dkt No. 2021PF00898 / 44755.2271PV01), filed on April 7, 2022, which is hereby incorporated by reference in its entirety as if fully set forth herein. Examples of pressure sensor housings and pressure sensor mounts (e.g., pressure sensor housings and / or pressure sensor mounts produced by additive manufacturing, 3D printing, or semiconductor manufacturing techniques) can be found in the following documents: U.S. Provisional Patent Application No. 63 / 330,380 (Atty Dkt No. 2021PF00908 / 44755.2268PV01), filed on April 13, 2022, U.S. Patent Application No. 17 / 188,012 (Atty Dkt No. 2021PF00908 / 44755.2268PV01), filed on March 1, 2021, and U.S. Patent Application No. 17 / 188,012 (Atty Dkt No. 2021PF00898 / 44755.2271 ... Dkt No. 2012P02343US03 / 44755.1227US03), U.S. Patent No. 10,932,678 to Burkett, filed May 22, 2018, U.S. Patent No. 9,974,446 to Burkett, and U.S. Provisional Patent Application No. 61 / 695,970 to Burkett, filed August 31, 2012, each of which is incorporated herein by reference in its entirety as if fully set forth herein. The pressure sensor can be secured within a pressure sensor housing using an adhesive and mounted to a pressure sensor mount such that a sensing element (e.g., a diaphragm disposed near a distal end of the sensor) is cantilevered, as described in U.S. Patent No. 6,167,763, which is incorporated herein by reference in its entirety as if fully set forth herein.

[0031] These descriptions are provided for exemplary purposes only and should not be considered to limit the scope of the metallic ink conductor assembly. Features may be added, deleted, or modified without departing from the spirit of the claimed subject matter.

[0032] For the purpose of promoting understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the accompanying drawings, and specific language will be used to describe the above aspects. However, it should be understood that there is no limitation on the scope of the present disclosure. Any changes and further modifications to the described devices, systems and methods, as well as any further applications of the principles of the present disclosure, are fully contemplated and included in the present disclosure, as would normally occur to a person skilled in the art in the field related to the present disclosure. Specifically, it is fully contemplated that the features, components and / or steps described in relation to one aspect may be combined with the features, components and / or steps described in relation to other aspects of the present disclosure. In addition, although aspects of the present disclosure are described with respect to blood vessels, it should be understood that the devices, systems and methods described herein may be configured for use in 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 aspects, 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, lungs; ducts; intestinal tract; nervous system structures including the brain, dural sac, spinal cord, and peripheral nerves; urethra; and valves within blood vessels, chambers or other parts of the heart and / or other systems of the body. In addition to natural structures, the devices can 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, the various repetitions of these combinations will not be described separately.

[0033] Figure 11 is a schematic top view of an intravascular device 102 according to aspects of the present disclosure. The intravascular device 102 can be an intravascular, intraluminal or intracavitary device, such as a guidewire, a catheter or a guide catheter, which is sized and shaped for positioning within a patient's blood vessel. The intravascular device 102 may include a sensor 112. For example, the sensor 112 can be a pressure sensor configured to measure the blood flow pressure within the patient's blood vessel. The intravascular device 102 includes a flexible, elongated member 106. The sensor 112 is disposed at a distal portion 107 (also referred to as a distal subassembly) of the flexible, elongated member 106. In some aspects, the sensor 112 can be mounted at the distal portion 107 and mounted within a housing 280. A flexible end coil 290 extends between the housing 280 and the distal end 108. The connecting portion 114 is disposed at a proximal portion 109 (also referred to as a proximal subassembly) of the flexible, elongated member 106. The connecting portion 114 includes conductive portions 132, 134, 136 separated by non-conductive portions 138, 140, 142, and 144. In some aspects, the conductive portions 132, 134, 136 can be conductive inks printed and / or deposited around the flexible elongated member 106. In some aspects, the conductive portions 132, 134, 136 can be conductive metal rings positioned around the flexible elongated member. The locking portion 118 and the knob or retaining portion 120 are disposed at the proximal portion 109 of the flexible elongated member 106.

[0034] Figure 1 The intravascular device 102 in the embodiment includes 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 are flexible metal rods that provide structure for the flexible slender member 106. The diameters of the distal core 210 and the proximal core 220 that electrically and mechanically connect the distal core 210 to the proximal core 220 may vary along their lengths. The joint between the distal core 210 and the proximal core 220 (which electrically and mechanically connects the distal core 210 to the proximal core 220) is surrounded and accommodated by a hypotube 215 (which is a tubular member).

[0035] In some aspects, the intravascular device 102 includes a distal component and a proximal component that are electrically and mechanically connected together, which results in electrical communication between the sensor 112 and the conductive portions 132, 134, 136. For example, pressure data obtained by the sensor 112 (in this example, the sensor 112 is a pressure sensor) can be transmitted to the conductive portions 132, 134, 136. Control signals from a computer in communication with the intravascular device 102 can be transmitted to the sensor 112 via the conductive portions 132, 134, 136. The distal subassembly may include a distal core 210. The distal subassembly may also include the sensor 112, a conductive member 230, and / or one or more layers of insulating polymer / plastic 240 surrounding the conductive member 230 and the distal core 210. For example, the polymer / plastic layer may protect the conductive member 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 layer 250) surrounding the proximal core 220 and / or a conductive tape 260 embedded in one or more layers of the polymer layer 250. In some aspects, the proximal subassembly and the distal subassembly can be manufactured separately. During the assembly process of the intravascular device 102, the proximal subassembly and the distal subassembly can be electrically and mechanically connected together. As used herein, a flexible, elongated member may refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220, etc.) and / or one or more components of the distal subassembly 210 (e.g., including the distal core 210, etc.).

[0036] In various aspects, the intravascular device 102 may include one, two, three, or more core wires, also referred to as core members, extending along its length. For example, a single core wire may extend substantially along the entire length of the flexible elongated member 106. In these aspects, the locking portion 118 and the knob or retaining portion 120 may be integrally formed at the proximal portion of the single core wire. The sensor 112 may be fixed at the distal portion of the single core wire. In other aspects, for example, Figure 1As shown in , the locking portion 118 and the knob or retaining portion 120 may be integrally formed at the proximal portion of the proximal core 220. The sensor 112 may be fixed at the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 in communication with the sensor 112. For example, the conductive member 230 may be one or more wires directly in communication with the sensor 112. In some cases, the conductive member 230 is electrically and mechanically connected to the sensor 112 and electrically connected thereto by, for example, soldering. In some cases, the conductive member 230 includes two or three wires (e.g., a two-wire cable or a three-wire cable). A single wire may include a bare metal conductor surrounded by one or more insulating layers. The conductive member or wire 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 wound around the distal core 210.

[0037] The intravascular device 102 includes one or more conductive strips 260 located at the proximal portion of the flexible elongated member 106. The conductive strips 260 are embedded in the polymer layer 250. The conductive strips 260 are in direct communication with the conductive portions 132, 134, and / or 136. In some cases, the conductive member 230 is electrically and mechanically coupled to the sensor 112 and in electrical communication therewith, for example, by soldering. In some cases, the conductive portions 132, 134, and / or 136 include conductive inks (e.g., metal nano-inks, such as silver or gold nano-inks) that are deposited or printed directly on the conductive strips 260.

[0038] As described herein, electrical communication between the conductive member 230 and the conductive ribbon 260 may 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 ribbon 260, the conductive portions 132, 134, 136 may be in electrical communication with the sensor 112.

[0039] exist Figure 1 In some aspects shown, the intravascular device 102 includes a locking portion 118 and a knob or retaining portion 120. To form the locking portion 118, the machining process can remove the polymer layer 250 and the conductive tape 260 in the locking portion 118 and form the proximal core 220 in the locking portion 118 into a desired shape. Figure 1 As shown, the locking portion 118 includes a reduced diameter, while the knob or retaining portion 120 has a diameter substantially similar to the diameter of the proximal core 220 in the connecting portion 114. In some cases, since the machining process removes the conductive tape in the locking portion 118, the proximal end of the conductive tape 260 will be exposed to moisture and / or liquids, such as blood, saline solution, disinfectant and / or enzymatic cleaning solutions, and thus the insulating layer 158 is formed on the proximal portion of the connecting portion 114 to insulate the exposed conductive tape.

[0040] Figure 2 1 is a schematic side view of an intraluminal (e.g., intravascular) sensing system 100 according to aspects of the present disclosure, the intraluminal sensing system 100 including an intravascular device 102, the intravascular device 102 including a conductive member 230 (e.g., a multi-filament conductor bundle) and a conductive band 260. The intravascular device 102 can be an intravascular guidewire that is sized and shaped for positioning within a patient's blood vessel. The intravascular device 102 includes a distal end 108 and a sensor 113. For example, the sensor 113 can be a pressure sensor and / or a flow sensor configured to measure blood flow pressure within a patient's blood vessel, or can be other types of sensors, including but not limited to temperature or imaging sensors, or a combination of sensors that measure more than one characteristic. For example, flow data obtained by the flow sensor can be used to calculate a physiological variable, such as coronary flow reserve (CFR). The intravascular device 102 includes a flexible, elongated member 106. The sensor 113 is disposed at a distal portion 107 of the flexible, elongated member 106. In some aspects, the sensor 113 can be mounted at the distal portion 107 and within the housing 282. The flexible end coil 290 extends proximally from the housing 282 at the distal portion 107 of the flexible elongated member 106. The connecting portion 114 disposed at the proximal end of the flexible elongated member 106 includes conductive portions 132, 134. In some aspects, the conductive portions 132, 134 can be conductive inks printed and / or deposited around the connecting portion 114 of the flexible elongated member 106. In some aspects, the conductive portions 132, 134 are conductive and can be metal bands or rings positioned around the flexible elongated member. The locking area is formed by a collar, or the locking portion 118 and the knob or retaining portion 120 are disposed at the proximal portion 109 of the flexible elongated member 106.

[0041] Figure 2The intravascular device 102 in the embodiment includes a core wire, which includes a distal core 210 and a proximal core 220. In some cases, the distal core 210 and the proximal core 220 are metal parts that form a part of the body of the intravascular device 102. For example, the distal core 210 and the proximal core 220 can be flexible metal rods that provide structure for the flexible elongated member 106. The distal core 210 and / or the proximal core 220 can be made of metal or metal alloy. For example, the distal core 210 and / or the proximal core 220 can be made of stainless steel, nitinol alloy, titanium, nickel-cobalt-chromium-molybdenum alloy (e.g., MP35N) and / or other suitable materials. In some cases, the distal core 210 and / or the proximal core 220 can be made of hard graphite or similar composite materials, such as carbon fiber, Kevlar fiber, etc. In some aspects, the distal core 210 and the proximal core 220 are made of the same material. In other aspects, 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 joint between the distal core 210 and the proximal core 220 is surrounded and contained by the hypotube 215. In some cases, the sensor 113 can be positioned at the distal end of the distal core 210.

[0042] In some aspects, the intravascular device 102 includes a distal subassembly and a proximal subassembly that are electrically and mechanically connected together so that electrical communication is established between the sensor 113 and the conductive portions 132, 134. For example, flow data obtained by the sensor 113 (in this example, the sensor 113 is a flow sensor) can be transmitted to the conductive portions 132, 134. In an exemplary aspect, the sensor 113 is a single ultrasonic transducer element. The transducer element transmits an ultrasonic signal and receives an echo. The transducer element generates an electrical signal representing the echo. The signal transmission wire transmits the electrical signal from the sensor located at the distal portion to the connector located at the proximal portion. The processing system 306 processes these electrical signals to extract the flow rate of the fluid.

[0043] Control signals from a processing system 306 (e.g., a processor circuit of the processing system 306) in communication with the intravascular device 102 may be transmitted to the sensor 113 via a connector 314 attached to the conductive portions 132, 134. The distal subassembly may include a distal core 210. The distal subassembly may also include the sensor 113, conductive members 230, and / or one or more insulating polymer / plastic layers 240 surrounding the conductive members 230 and the distal core 210. For example, the polymer / plastic layer may insulate and protect the conductive members in the conductive members 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 a conductive tape 260 embedded in one or more insulating and / or polymer layers 250. In some aspects, the proximal subassembly and the distal subassembly are manufactured separately. In the assembly process of the intravascular device 102, the proximal subassembly and the distal subassembly can be electrically and mechanically connected together. As used herein, the flexible slender member can refer to one or more parts along the entire length of the intravascular device 102, one or more parts of the proximal subassembly (e.g., including the proximal core 220, etc.) and / or one or more parts of the distal subassembly (e.g., including the distal core 210, etc.). Therefore, the flexible slender member can refer to the above-mentioned combined proximal and distal subassemblies. The joint between the proximal core 220 and the distal core 210 is surrounded by a hypotube 215 (which is a tubular member).

[0044] In various aspects, 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 aspects, the locking portion 118 and the knob or retaining portion 120 may be integrally formed at the proximal portion of the single core wire. The sensor 113 may be fixed at the distal portion of the single core wire. In other aspects, for example Figure 2, the locking portion 118 and the knob or retaining portion 120 may be integrally formed at the proximal portion of the proximal core 220. The sensor 113 may be fixed at the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 (e.g., a multifilament conductor bundle or cable) that are in communication with the sensor 113. For example, the conductive member or wire 230 may be one or more wires that are directly in communication with the sensor 113. In some cases, the conductive member 230 is electrically and mechanically coupled to the sensor 113 and electrically communicated with it by, for example, soldering. In some cases, the conductive member 230 includes two or three wires (e.g., a two-wire cable or a three-wire cable). A single 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 wound around the distal core 210, thereby minimizing or eliminating the swing of the distal core in a tortuous anatomical structure.

[0045] The intravascular device 102 may include one or more conductive strips 260 located at the proximal portion of the flexible elongated member 106. The conductive strips 260 are embedded in the polymer layer 250. The conductive strips 260 are directly connected to the conductive portions 132 and / or 134. In some cases, the conductive member 230 is electrically and mechanically coupled to the sensor 113 and electrically connected thereto by, for example, soldering. In some cases, the conductive portions 132 and / or 134 include conductive inks (e.g., metal nano-inks, such as copper, silver, gold, or aluminum nano-inks) deposited or printed directly on the conductive strips 260.

[0046] As described herein, electrical communication between the conductive member 230 and the conductive strip 260 may be established at the connecting portion 114 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 may be in electrical communication with the sensor 113.

[0047] exist Figure 1 In some aspects shown, the intravascular device 102 includes a locking portion 118 and a knob or retaining portion 120. To form the locking portion 118, a machining process is used to remove the polymer layer 250 and the conductive tape 260 in the locking portion 118 and to shape the proximal core 220 in the locking portion 118 into a desired shape. Figure 1As shown, the locking portion 118 includes a reduced diameter, while the knob or retaining portion has a diameter substantially similar to the diameter of the proximal core 220 in the connecting portion 114. In some cases, due to the machining process removing the conductive tape in the locking portion 118, the proximal end of the conductive tape 260 will be exposed to moisture and / or liquids, such as blood, saline solution, disinfectant and / or enzymatic cleaning solutions, forming an insulating layer 158 on the proximal portion of the connecting portion 114 to insulate the exposed conductive tape 260.

[0048] In some aspects, connector 314 provides an electrical connection between conductive portions 132, 134 and a patient interface monitor (PIM) 304. In some cases, PIM 304 may be connected to a console or processing system 306 that includes or communicates with a display 308. It should be noted that Figure 1 The pressure sensing guidewire may also similarly communicate with the same or different connector 314 , PIM 304 , processing system 306 , and display 308 .

[0049] The intraluminal sensing system 100 can be deployed in a catheterization lab having a control room. The processing system 306 can be located in the control room. Alternatively, the processing system 306 can be located elsewhere, such as in the catheterization lab itself. The catheterization lab can include a sterile area, and its associated control room can be sterile, or it can be non-sterile, depending on the procedure to be performed and / or depending on the medical facility. In some aspects, the intravascular device 102 can be controlled from a remote location such as a control room, so that the operator does not need to be close to the patient.

[0050] The intravascular device 102, PIM 304, and display 308 may be communicatively coupled to a processing system 306, either directly or indirectly. These elements may be communicatively coupled to the processing system 306 via a wired connection (e.g., conductive member 230, which is a standard copper multifilament conductor bundle). The processing system 306 may be communicatively coupled to one or more data networks, such as a TCP / IP-based local area network (LAN). In other aspects, different protocols may be used, such as a synchronous optical network (SONET). In some cases, the processing system 306 may be communicatively coupled to a wide area network (WAN).

[0051] The PIM 304 transmits the received signals to a processing system 306 where the information is processed and displayed (e.g., as physiological data in graphical, symbolic, or alphanumeric form) on a display 308. The console or processing system 306 may include a processor and memory. The processing system 306 may be operable to facilitate the functions of the intraluminal sensing system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-transitory tangible computer-readable medium.

[0052] The PIM 304 facilitates signal communication between the processing system 306 and the intravascular device 102. The PIM 304 can be communicatively positioned between the processing system 306 and the intravascular device 102. In some aspects, preliminary processing of the data is performed before forwarding the data to the processing system 306. In examples of such aspects, the PIM 304 performs amplification, filtering, and / or aggregation of the data. In one aspect, the PIM 304 also provides high and low voltage DC power through the conductive member 230 to support the operation of the intravascular device 102.

[0053] A multifilament cable or transmission harness, such as conductive member 230, may include multiple conductors, including one, two, three, four, five, six, seven, or more conductors. Figure 2 In the example shown, the conductive member 230 includes: two straight sections 232 and 236, where the conductive member 230 is parallel to the longitudinal axis of the flexible elongated member 106; and a spiral section 234, where the conductive member 230 is wrapped around the outside of the flexible elongated member 106 and then coated with an insulating polymer / plastic 240. Communication along the conductive member 230, if any, can be carried out through a variety of methods or protocols, including serial, parallel, and other ways, where one or more filaments of the conductive member 230 transmit signals. One or more filaments of the conductive member 230 can also transmit direct current (DC) power, alternating current (AC) power, or serve as a ground connection.

[0054] The display or monitor 308 can be a display device, such as a computer monitor or other type of screen. The display or monitor 308 can be used to display selectable prompts, instructions, and visual representations of imaging data to the user. In some aspects, the display 308 can be used to provide the user with a procedure-specific workflow to complete the intraluminal imaging procedure.

[0055] although Figure 1 and Figure 2 Details of specific intraluminal measurement devices are shown, but it should be understood that these examples are illustrative rather than limiting and that the present disclosure is applicable to other types of intravascular devices than those shown or described herein.

[0056] Figure 3 is a schematic cross-sectional view of an example sensor assembly 251 according to aspects of the present disclosure, which sensor assembly may be included in, for example, Figure 2 More specifically, Figure 3 A sensor assembly 251 including a sensing component 113, a housing 282, and an acoustic matching layer 252 is shown. Figure 2As shown in the positions of the sensing component 113 and the housing 282 shown in , the sensor assembly 251 can be included in a distal portion of the intravascular device 102 such that a surface 272 of the sensing component 113 faces distally.

[0057] like Figure 3 As shown, the sensing component 113 is positioned within the housing 280 and includes a proximal surface 271, an opposite distal surface 272, and a side surface 274. In some embodiments, one or more of the proximal surface 271, the distal surface 272, or the side surface 274 may be coated in an insulating layer 276. The insulating layer 276 may be formed, for example, of polyparaxylene, which may be deposited on one or more surfaces. The insulating layer 276 may additionally or alternatively be formed of any other suitable insulating material. In some embodiments, the insulating layer 276 may prevent short circuits (e.g., electrical faults) that may otherwise be caused by contact between the conductive portion of the sensing component 113 and the housing 282, which may be formed of metal. As used herein, unless otherwise noted, in embodiments where the distal end of the sensing component 113 is covered by the insulating layer 276, reference to the distal surface 272 encompasses the insulating layer 276, in embodiments where the proximal end of the sensing component 113 is covered by the insulating layer 276, reference to the proximal surface 271 encompasses the insulating layer, and in embodiments where the side of the sensing component 113 is covered by the insulating layer 276, reference to the side surface 274 encompasses the insulating layer.

[0058] In some embodiments, the sensing component 113 may include a transducer element, such as an ultrasonic transducer element on the distal surface 272, such that the transducer element faces distally and can be used by the sensing component 113 to obtain sensor data corresponding to structures distal to the sensing component 113. The sensing component 113 may additionally or alternatively include a transducer element located on the proximal surface 271, such that the transducer faces proximally and can be used to obtain sensor data corresponding to structures proximal to the sensing component. In some embodiments, the transducer element may additionally or alternatively be positioned on the side surface 274 of the sensing component 113 (e.g., on the periphery or circumference). In some embodiments, the transducer and its associated electrodes and electrical connection points may form the entire sensing component 113, such that all surfaces of the sensing component 113 include the transducer.

[0059] As further shown, the sensing component 113 is coupled to the multifilament conductor bundle 230, and at least a portion (e.g., a distal portion) of the multifilament conductor bundle 230 extends through the housing 282. In some embodiments, the multifilament conductor bundle 230 and the sensing component 113 may be physically (e.g., mechanically) coupled. In addition, one or more wires (e.g., conductive members) of the multifilament conductor bundle 230 may be electrically coupled (e.g., electrically connected) to the sensing component 113. Specifically, one or more wires of the multifilament conductor bundle 230 may be coupled to an element (e.g., a transducer (e.g., an ultrasonic transducer)) of the sensing component 113, and may provide power, control signals, electrical grounding, or signal return, etc. to the element. As described above, such an element may be positioned on the distal surface 272 of the sensor. In this regard, in some embodiments, one or more wires in the multifilament conductor bundle 230 may extend through a cutout or hole in the sensing component 113 (e.g., at least in the proximal surface 271) so as to establish electrical communication with an element on the distal surface 272 of the sensor. The wires may additionally or alternatively be wrapped around the side surface 274 to establish electrical communication with elements on the distal surface 272. Furthermore, in some embodiments, the wires of the multi-filament conductor bundle 230 may terminate at and / or electrically couple to the proximal surface 271 (e.g., elements on the proximal surface 271) of the sensing component 113. Furthermore, in some embodiments, for example, a subset of the wires of the multi-filament conductor bundle 230 may extend to and / or electrically couple to elements at the distal surface 272, while a different subset of the wires may be electrically coupled to elements at the proximal surface 271.

[0060] In some embodiments, the multi-filament conductor bundle 230 may be coated in an insulating layer 276. In some embodiments, for example, the multi-filament conductor bundle 230 and the sensing component 113 may be coupled together in a subassembly and then positioned in the housing 282. In such embodiments, the insulating layer 276 may be applied (e.g., coated and / or deposited) to the entire subassembly, thereby creating an insulating layer 276 on both the sensing component 113 and the multi-filament conductor bundle 230.

[0061] In some embodiments, the acoustic matching layer 252 may be positioned on (e.g., above) the distal surface 272 of the sensing component 113. Specifically, the acoustic matching layer 252 may be disposed directly on the sensing component 113, or the acoustic matching layer 252 may be disposed on an insulating layer 276 covering the sensing component 113. In addition, the acoustic matching layer 252 may be disposed on a transducer element (e.g., an ultrasonic transducer element) positioned on the sensing component (e.g., the distal surface 272) and / or on at least a portion of the conductive wires of the multi-filament conductor bundle 230 that communicate with the transducer element (e.g., a wire extending through a hole of the sensing component 113 or extending along a side of the sensing component 113). To this end, the acoustic matching layer 252 may contact and / or at least partially surround the portion of the conductive wires and / or the transducer element. In addition, the acoustic matching layer 252 may provide acoustic matching with the sensing component 113 (e.g., with an ultrasonic transducer of the sensing component 113). For example, the acoustic matching layer 252 can minimize the acoustic impedance mismatch between the ultrasonic transducer and the sensed medium (e.g., the fluid and / or lumen in which the intravascular device 102 is positioned). In this regard, the acoustic matching layer 252 can be formed of any suitable material (e.g., a polymer or adhesive) to provide acoustic matching with the sensing component 113. The portion of the acoustic matching layer 252 positioned on the distal surface 272 can include and / or be formed of the same material as a portion of the acoustic matching layer positioned on the side surface 274 and / or the proximal surface 271. In addition, during the assembly process of the sensor assembly 251, the acoustic matching layer 252 can be applied to the sensing component 113 before or after the sensing component 113 is positioned within the housing 282. In this regard, the portion of the acoustic matching layer 252 positioned on the distal surface 272 and the portion of the acoustic matching layer positioned on the side surface 274 and / or the proximal surface 271 can be included in the sensor assembly 251 in the same or different steps. Furthermore, the acoustic matching layer 252 may provide acoustic matching to the sensing component 113 through one or more dimensions of the acoustic matching layer 252 in addition to the material or materials from which the acoustic matching layer 252 is formed.

[0062] In some embodiments, the sensor assembly 251 may include an atraumatic tip, such as Figure 1. In some embodiments, the distal tip 108 may include the same material as the acoustic matching layer 252. In some embodiments, the distal tip may include a material different from the acoustic matching layer 252. Additionally or alternatively, the distal tip 108 may be formed of one or more layers of material. These layers may include different materials and / or different configurations (e.g., shapes and / or profiles, thicknesses, etc.). In addition, the distal tip 108 may be arranged to cover the distal surface 272 of the sensing component 113. In some embodiments, the distal tip 108 may also cover the distal end 272 of the shell 282. In addition, although the distal tip 108 is shown as having a dome shape, embodiments are not limited thereto. In this regard, the distal tip 108 may include a flat profile or any suitable shape. In some embodiments, the entire sensing component 113 may be positioned within the shell 282 (e.g., surrounded by a continuous surface of the shell 282).

[0063] Figure 4 is a schematic cross-sectional view of an intraluminal (eg, intravascular) sensing device 102 including both a pressure sensor 112 and a flow sensor 113 in accordance with aspects of the present disclosure. Figure 4 In the example shown, the intraluminal sensing device includes a flow sensor 113 positioned at the distal end of the flexible elongated member 106. The flow sensor 113 can be at least partially housed in a flow sensor housing 282. A coil 290 is disposed proximal to the flow sensor housing 282. Proximal to the coil is a pressure sensor housing 280, which can at least partially surround a pressure sensor mount 412, to which the pressure sensor 112 is attached. The proximal end of the flexible elongated member 106 is a connecting portion 114, which includes a plurality of conductive portions 432, such as conductive strips as described above. In one example, the pressure sensor 112 can be operated by three conductor paths, such as three conductive wires or filaments, or two conductive wires or filaments plus a conductive core wire. Thus, three conductive strips 432 can be electrically connected to the pressure sensor 112. It should be noted that the conductive wires or filaments can have a circular cross-section or a flat ribbon cross-section, or other cross-sections, and can include multiple segments with different cross-sections and / or different materials.

[0064] In one example, the flow sensor 113 can be operated by two conductor paths, such as two conductive wires or filaments, or one conductive wire or filament plus a conductive core wire. Therefore, two conductive strips 432 can be electrically connected to the flow sensor 113. Therefore, the connection portion 114 may include five conductive strips 432. In some cases, there may be four conductive strips 432. Two are used for the pressure sensor and two are used for the flow sensor. The pressure sensor can still be connected to 3 wires or filaments, but one of the wires or filaments will be grounded (e.g., grounded to the core wire) and therefore no conductive strip is required. However, in some embodiments, the two conductive paths for operating the flow sensor 113 can be shared by the pressure sensor (e.g., by operating the pressure sensor at some times and operating the flow sensor at other times). In such an embodiment, there can be three conductive strips 432 in the connection portion 114. In some cases, there can be two conductive strips 432 (both shared by the pressure sensor and the flow sensor). The pressure sensor can still be connected to 3 wires or filaments, but one of the wires or filaments can be grounded (e.g., grounded to the core wire) and therefore no conductive strip is required. Depending on the implementation, other numbers of conductive strips or conductive paths may alternatively or additionally be used.

[0065] Other numbers or arrangements of sensors may also be used. In an intraluminal sensing device comprising a first sensor and a second sensor, the first sensor may include any suitable sensing modality (e.g., pressure, flow, temperature, imaging, etc.). The second sensor may also be any suitable modality (e.g., pressure, flow, temperature, imaging, etc.), whether the same or different modality as the first sensor.

[0066] Figure 5 is a schematic cross-sectional side view of a sensor mount 412 (e.g., a pressure sensor mount) having an embedded signal transmission conductive material 510 according to aspects of the present disclosure. In one example, the sensor mount 412 includes a sensor mount body 520, which includes a sensor mount platform 530 and a sensor cantilever recess 540. The sensor mount body 520 can be made of, for example, a metallic material. In other embodiments, the sensor mount body 520 can be made of an electrically insulating material or a combination of electrically insulating and conductive (e.g., metallic) materials. As shown below Fig.12 As shown in FIG. , the sensor mount 412 may be attached to a core wire (e.g., Figure 1 The distal core wire 210 in the sensor housing (eg, Figure 1 The sensor housing 280 is located in the sensor housing 280.

[0067] The signal transmission conductive material 510 may be embedded in the sensor mount body 520 and may be surrounded by an insulating material 550, which may be in contact with the material of the sensor mount body 520 and may also be in contact with the signal transmission conductive material 510, for example, to prevent electrical contact between the sensor mount body 520 and the signal transmission conductive material 510. Figure 5 In the example shown, the signal transmission conductive material 510 includes one or more proximal terminals 560, one or more distal terminals 570, and one or more embedded conductors 580 that electrically connect the proximal terminals 560 to the distal terminals 570. Thus, the proximal terminals 560 and the distal terminals 570 form a portion of the outer surface of the sensor mount body 520, so that electrical signals can be routed from the proximal end to the distal end of the sensor mount 412 without having to have insulated wires or filaments running alongside the sensor mount 412 within the sensor housing 280. This can, for example, allow the sensor housing 280 to have a smaller size that more closely fits the sensor mount 412, or can allow the sensor mount 412 and the sensor housing 280 to be manufactured together as a single object.

[0068] Therefore, for some implementations, from the inside out, Figure 5 One or more channels formed of signal transmission conductive material 510 are shown, surrounded by electrically insulating (e.g., dielectric) material 550, and then surrounded by conductive material 590 (which may be the same or different material than signal transmission conductive material 510), thereby forming an outer surface 595 of sensor mount body 520, as well as an outer surface of sensor mount 412. Depending on the implementation, conductive material 590 may or may not transmit a signal. In the case of transmitting a signal, the signal transmitted by conductive material 590 may be different from any signal transmitted by signal transmission conductive material 510.

[0069] Depending on the implementation, the signal transmission conductive material 510 may constitute the structure of the sensor mount 412, or the signal transmission conductive material 510 may form a part of the structure of the sensor mount 412, or the signal transmission conductive material 510 may be positioned within the inner / outer perimeter of the sensor mount 412, such as Figure 5 and Fig.12 As shown. In some cases, the structure of sensor mount 412 is homogenous and used to transmit electrical signals. Other arrangements can also be used, including combinations of conductive and insulating materials (e.g., in alternating layers or other arrangements) that have the same or similar functions of transmitting signals to and from the distal component through sensor mount 412.

[0070] Thus, for a combined intraluminal physiological sensing device comprising two or more sensors, the sensor mount 412 includes a conductive pathway that transmits a signal for another sensor (e.g., a sensor disposed distally of the sensor mount 412 and / or physically separated from the sensor mount 412).

[0071] Below Figure 6 The detail area marked by the dashed rectangle is shown at a larger magnification.

[0072] One or more sensors may be mounted on a sensor mount (e.g., sensor mount 412) such that the sensor mount physically supports the one or more sensors. In some cases, housing 282 may also be the sensor mount. A first sensor (e.g., Figure 4 The pressure sensor 112) and the second sensor (eg, Figure 4 In some cases, the first sensor is mounted on the sensor mount and the second sensor is not mounted on the sensor mount (e.g., the second sensor is spaced apart from the sensor mount). In some cases, the second sensor is mounted on the sensor mount and the first sensor is not mounted on the sensor mount (e.g., the first sensor is spaced apart from the sensor mount 412). In some cases, the first sensor, the second sensor, and / or the other sensors are mounted on the sensor mount. In some cases, the sensor mount may include an embedded conductive pathway (e.g., forming part of the structure of the sensor mount) that transmits a signal for the second sensor. In some cases, the sensor mount may include an embedded conductive pathway that transmits a signal for the first sensor. In some cases, the sensor mount may include an embedded conductive pathway that transmits a signal for the first sensor, the second sensor, and / or the other sensors.

[0073] Figure 6 is a schematic cross-sectional view of a detail area of ​​a sensor mount 412 (e.g., a pressure sensor mount) having an embedded signal transmission conductive material 510 according to aspects of the present disclosure. Visible are a sensor mount body 520, signal transmission conductive material 510, proximal terminals 560, embedded conductors 580, and insulating material 550. In some embodiments, the sensor mount body 520 is at least partially made of insulating material 550.

[0074] Figure 7is a schematic top view of a sensor mount 412 (e.g., a pressure sensor mount) with embedded signal transmission conductive material according to aspects of the present disclosure. Visible are a sensor mount body 520, a sensor mount platform 530, a sensor cantilever recess 540, two proximal terminals 560 (each surrounded by insulating material 550), and two distal terminals 570 (each surrounded by insulating material 550). Depending on the implementation, instead of or in addition to Figure 7 Other numbers of terminals (and their associated embedded conductors) may be provided beyond those shown in FIG.

[0075] As shown, terminals 560 and 570 are proximal terminals and distal terminals, respectively. In other cases, the terminals may be located anywhere along the length of sensor mount 412. As shown, the terminals are exposed at the top surface of sensor mount 412. In other cases, one or more terminals may be exposed on any surface of sensor mount 412 (including proximal surface, distal surface, right side surface, left side surface, top surface, bottom surface, or a combination thereof).

[0076] Below Figure 8 The detailed area marked by the dashed rectangle is shown at a larger magnification.

[0077] Figure 8 is a schematic cross-sectional view of a detail area 790 of an example sensor mount 412 according to aspects of the present disclosure. Visible are the sensor mount body 520 and two proximal terminals 560, each of which is surrounded by insulating material 550. Depending on the implementation, alternatively or in addition to Figure 8 Other numbers of terminals (and their associated embedded conductors) may be provided beyond those shown in FIG.

[0078] Fig. 9 1 is a wiring schematic for an intraluminal (e.g., intravascular) sensing device 102 including both a pressure sensor 112 and a flow sensor 113 according to aspects of the present disclosure. A connecting portion 114 of the intraluminal device 102 includes a plurality of conductive portions 432 (e.g., conductive strips) to which wires, threads, or conductors 230f and 230p are electrically connected. Three wires or threads 230p extending from the connecting portion 114 are connected to electrical contacts 940 on the pressure sensor 112 to transmit power and signals between the connecting portion 114 and the pressure sensor 112. Two wires or threads 230f extending from the connecting portion 114 are connected to the proximal end of an embedded conductor 580 located within the sensor mount 412 (e.g., by connecting to a Figure 7 Two distal wires, threads or conductors 930f extend from the embedded conductor 580 of the sensor mount 412 (e.g., via Figure 7The distal terminal 570 of the pressure sensor 112 is connected to the electrical contact 950 of the flow sensor 113. In one example, the wires or filaments 230p, 230f and 930f are electrically joined (e.g., by solder, conductive adhesive, ultrasonic welding or other means) to the electrical contacts 940 and 950 or other terminals or contacts. It should be understood that the pressure sensor 112 can be positioned on the pressure sensor mount 412 and coupled thereto.

[0079] Thus, an electrical connection (e.g., for transmitting power and signals) can be provided between the connection portion 114 and the flow sensor 113 without requiring the wire or filament 230f to extend directly from the connection portion 114 to the flow sensor 113 by extending alongside the pressure sensor mount 412. This arrangement can reduce costs and manufacturing errors by allowing a simplified assembly process to be implemented while also allowing the pressure sensor mount 412 and the pressure sensor housing (e.g., Figure 4 The gap between the sensor housing 280) is smaller because the gap does not need to accommodate wires or wires. The resulting device can also be more stable during handling and use.

[0080] Fig. 9 One or more of the five wires, filaments or conductors 230p, 230f shown in the figure may be a continuous length, or may be multiple wires / conductors that are electrically and mechanically coupled. For example, a portion of the length may be a wire, such as extending along / wrapped around a distal core wire, and a portion of the length may be a ribbon conductor, such as extending along a proximal core wire / embedded in a polymer surrounding the proximal core wire. The wire or filament or a portion thereof may be surrounded by a polymer insulator (e.g., such as Figure 1 and 2 As shown, a bare metal conductor is provided at a proximal portion of the guidewire, or at other locations depending on the implementation. The exposed portion of the bare conductor at the end (e.g., the portion without the insulator) can make electrical contact.

[0081] exist Fig. 9 In the example shown, the embedded conductor 580 is shown as a rectangle, while the other wires, threads or conductors 230p, 230f, 930f are shown as flexible wires. For example, the wires can be wrapped around the distal core wire or routed around or adjacent to other components, while the embedded conductor 580 is fixed within the pressure sensor mount 412. Power and / or signals transmitted through the distal wire or thread 930f and / or the embedded conductor 580 may include, but are not limited to, power from the PIM 304 and / or the processing system 306 (see Figure 2) to the sensors, command or control signals from the PIM 304 and / or processing system 306 to the sensors, data obtained from the sensors and transmitted back to the PIM 304 and / or processing system 306, or electrical ground, for any suitable sensing modality, including, but not limited to, pressure, flow, temperature, imaging, etc. Sensors 112 and 113 can be different from each other (e.g., structurally / physically different sensors), can face in different directions (e.g., one facing forward and one facing sideways), can have different sensing modalities, etc. For example, sensor 112 can be a pressure sensor, while sensor 113 can be a flow sensor. In other respects, sensors 112 and 113 can be similar or identical to each other.

[0082] Replace or remove Fig.13 Other numbers or arrangements of wires, filaments, embedded conductors, or other conductive pathways may be provided in addition to those shown in the drawings without departing from the spirit of the present disclosure. In some aspects, the pressure sensor 112 may not be positioned on the pressure sensor mount 412. Thus, in a combined intraluminal physiological sensing device, a sensor mount for a first sensor includes a conductive material that transmits a signal for a different second sensor of the device (e.g., a sensor not supported by the sensor mount and / or a sensor spaced apart from the sensor mount and / or the first sensor).

[0083] The flow signal paths each include conductive segments 930f, 580, 230f, or a combination of other segments that extend between the flow sensor 113 and the connecting portion 114 to provide a continuous path for an electrical signal associated with the flow sensor 113 (e.g., from the flow sensor 113 to the connector 114). Figure 2 Some of the conductive segments may be wires, threads, ribbons, conductive inks, conductive tapes, or other. Importantly, one of the conductive segments in each flow signal path is a signal transmitting conductive material embedded in the sensor mount. There may be one or more flow signal paths (e.g., Fig. 9 The two flow signal paths shown in Figure ).

[0084] The pressure signal paths each include a combination of conductive segments 230p that extend between the pressure sensor and the connection portion to provide a continuous path for the electrical signal (e.g., from the pressure sensor 112 to the PIM 304 or processing system 306, from the PIM 304 or processing system 306 to the pressure sensor 112, or from the pressure sensor 112 to electrical ground). Some of the conductive segments may be wires, threads, wire strips, conductive inks, conductive tapes, conductive core wires, or other. There may be one or more pressure signal paths (e.g., Fig. 9 , but one of the three paths may be grounded before reaching the connecting portion 114).

[0085] Fig.10 is a sensor mount 412 (eg, a pressure sensor mount) according to aspects of the present disclosure (its schematic wiring diagram is shown in FIG. Fig. 9 1 and 1 . The sensor mount 412 includes a sensor mount body 520, which includes a sensor mount platform 530 and a sensor cantilever recess 540. The sensor 112 is attached to the outer surface of the sensor mount platform 530 (e.g., using an adhesive). Fig.10 In the example shown, Fig. 9 As in the example of FIG. 4 , three wires or threads 230p are connected to pads 1032 on sensor 112 and two wires or threads 230f are connected to proximal terminals 560 of sensor mount 412. Two distal wires or threads 930f are connected to distal terminals 570 of sensor mount 412 to provide electrical connection to the flow sensor located distal to pressure sensor mount 412. It should be noted that on the proximal side of sensor mount 412, wires or threads 230p and 230f are electrically coupled to and form an electrical path with connection portion 114, as shown above. Fig. 9 Similarly, at the distal side of the sensor mount 412, the distal wire or filament 930f is electrically connected to the flow sensor 113 and forms an electrical path with the flow sensor 113, as shown above. Fig. 9 as shown in .

[0086] The sensor mount 412 also includes a core wire lumen 1015 (which may also be described as a core wire groove, a core wire area, a core wire space, or a core wire opening), and an optional solder or glue hole 1017 to facilitate attaching the sensor mount 412 to the core wire and / or to a forming band coupled to the sensor mount 412 and extending distally of the sensor mount. The core wire lumen 1015 may, for example, be configured to receive the distal core wire 210 (see Figure 1). The pad 1032 of the sensor 112 is disposed on the fixed portion 214 of the sensor 112, and the diaphragm or other sensing element 1012 is disposed on the cantilever portion 1016 of the sensor 112, and the cantilever portion 1016 is spaced apart from and disposed above the sensor cantilever recess 540. In some embodiments, the bottom surface of the sensor cantilever recess 540 can be completely deleted so that the bottom of the sensor cantilever recess 540 is open to the core wire lumen 1015.

[0087] Fig.11 According to various aspects of the present disclosure Fig.10 4 is a schematic top view of a sensor mount 412. Visible are the sensor mount body 520, the sensor mount platform 530, the sensor cantilever recess 540, the sensor 112, the optional solder or glue hole 1017, the solder pad 1032 of the sensor 112, the fixed portion 214 of the sensor 112, and the sensing element 1012 located on the cantilever portion 1016 of the sensor 112, which is disposed above the sensor cantilever recess 540.

[0088] exist Fig.11 In the example shown, Fig. 9 and Fig.10 As shown, three wires or filaments 230p are connected to pads 1032 on the sensor 112, and two wires or filaments 230f are connected to the proximal terminals 560 of the sensor mount 412. Two distal wires 930f are connected to the distal terminals 570 of the sensor mount 412 to provide electrical connections for the flow sensor located distally of the pressure sensor mount 412.

[0089] Cross-sectional line 12-12 shows Fig.12 The location of the cross-sectional view.

[0090] Fig.12 A cross-sectional view taken along the cross-sectional line 12-12 (perpendicular to the longitudinal axis of the core wire) according to various aspects of the present disclosure Fig.11 Schematic side cross-sectional view of sensor mount 412. Figures 2 to 8 as well as Figure 10 to Figure 11 The arrangement of the components is shown vertically, but Fig.12 A lateral cross section shows the arrangement of components laterally or radially, which is perpendicular to the longitudinal view.

[0091] Visible is the pressure sensor housing 280, which forms the outermost surface of the intraluminal device at this location. Radially inward from the housing 280 is the cantilevered portion 1016 of the pressure sensor 112, which is disposed above the sensor mount body 520 and is partially surrounded by the sensor housing 280, which includes an upper opening 1210 located above the pressure sensor 112. The sensor mount body is positioned radially inward from the pressure sensor housing 280 and is partially surrounded by the pressure sensor housing 280. Within the sensor mount body 520 are two embedded conductors 580, each surrounded by a layer of insulating material 550. On the lower portion of the sensor mount body 520 is the core wire lumen 1015 (which may also be described as a groove, recess, depression, etc.), which partially surrounds the distal core wire 210 at the lowermost portion of the sensor mount body 520.

[0092] This configuration does not require a wire or thread to pass through the sensor housing 280 adjacent to the sensor mount 412, and thus may allow a smaller sensor housing 280, a larger sensor mount 412, and / or a tighter fit between the sensor housing 280 and the sensor mount 412, or may allow the sensor mount 412 and the sensor housing 280 to be combined into a single object.

[0093] In some cases, the housing and the mount are different components (e.g., they are connected to each other). In some cases, the housing and the mount are the same component (e.g., as shown in U.S. Provisional Patent Application No. 63 / 330,380 (Atty Dkt No. 2021PF00908 / 44755.2268PV01), filed on April 13, 2022, which is incorporated herein by reference above). That is, the same component defines the outermost surface of the intraluminal device, as well as space for the core wire and space for the pressure sensor. Signal transmission conductive material and electrically insulating (e.g., dielectric) material can be provided in this same component.

[0094] Fig.13 1 is a wiring diagram of an intraluminal (e.g., intravascular) sensing device 102 including both a pressure sensor 112 and a flow sensor 113 according to aspects of the present disclosure. A connecting portion 114 of the intraluminal device 102 includes a plurality of conductive portions 432 (e.g., conductive strips) to which wires, threads, or conductors 230a and 230p are electrically connected. Three wires or threads 230p and 230a extend from the connecting portion 114 and connect to electrical contacts 940 on the pressure sensor 112 to transmit power and signals between the connecting portion 114 and the pressure sensor 112. However, unlike Fig. 9Unlike the illustrated embodiment, there is no wire extending from the connection portion 114 connected to the proximal end of the embedded conductor 580 within the sensor mount 412. Instead, two bonding wires or jumpers 1330 connect the two electrical contacts 940 of the pressure sensor 112 to the proximal end of the embedded conductor 580 (e.g., by connecting to Figure 7 Two distal wires, threads or conductors 930f extend from the embedded conductor 580 of the sensor mount 412 (e.g., via Figure 7 The distal terminal 570 of the pressure sensor 112 is connected to the electrical contact 950 of the flow sensor 113. It should be understood that in most cases, the pressure sensor 112 will be positioned on the pressure sensor mounting base 412 and connected thereto.

[0095] Thus, an electrical connection (e.g., for transmitting power and signals) can be provided between the connection portion 114 and the flow sensor 113 without requiring a wire or thread to extend directly from the connection portion 114 to the flow sensor 113 by extending alongside the pressure sensor mount 412. In addition, the two electrical pathways defined by the wire or thread 230a are shared between the pressure sensor 112 and the flow sensor 113. This can be achieved, for example, by operating the pressure sensor 112 and the flow sensor 113 at different times, at different frequencies, using different digital sequences, or in other ways.

[0096] The wire, filament or conductor or a portion thereof may be a bare metal conductor surrounded by a polymer insulator. The electrical pathway shown may include multiple conductive elements comprising the same, similar or different materials. Fig.13 Other numbers of wires or filaments 230p, 230a or 950f, embedded conductors 580, jumpers 1330, or other conductive pathways may be provided in addition to those shown in FIG.

[0097] The flow signal paths each include conductive segments 930f, 580, 1330, 230a, or other combinations of segments that extend between the flow sensor 113 and the connecting portion 114 to provide a continuous path for electrical signals associated with the flow sensor 113 (e.g., from the flow sensor 113 to the connector 114). Figure 2 Some of the conductive segments may be wires, threads, ribbons, conductive inks, conductive tapes, or other. Importantly, one of the conductive segments in each flow signal path is a signal transmitting conductive material embedded in the sensor mount. There may be one or more flow signal paths (e.g., Fig.13 The two flow signal paths shown in Figure ).

[0098] The pressure signal paths each include a combination of conductive segments 230a, 230p that extend between the pressure sensor and the connection portion to provide a continuous path for the electrical signal (e.g., from the pressure sensor 112 to the PIM 304 or processing system 306, from the PIM 304 or processing system 306 to the pressure sensor 112, or from the pressure sensor 112 to electrical ground). Some of the conductive segments may be wires, threads, wire strips, conductive inks, conductive tapes, conductive core wires, or other. There may be one or more pressure signal paths (e.g., Fig.13 , but one of the three paths may be grounded before reaching the connecting portion 114).

[0099] Fig.14 is a sensor mount 412 (eg, a pressure sensor mount) according to aspects of the present disclosure (its schematic wiring diagram is shown in FIG. Fig.13 1 and 1 . The sensor mount 412 includes a sensor mount body 520, which includes a sensor mount platform 530 and a sensor cantilever recess 540. The sensor 112 is attached to the sensor mount platform 530. Fig.14 In the example shown, Fig.13 As shown, three wires or threads 230p, 230a are connected to pads 1032 on the sensor 112, and two bonding wires or jumpers 1330 are connected between the two pads 1032 on the sensor 112 and the two proximal terminals 560 of the sensor mount 412. Two distal wires or threads 930f are connected to the distal terminals 570 of the sensor mount 412 to provide electrical connection to a flow sensor disposed distally of the pressure sensor mount 412.

[0100] The sensor mount 412 also includes a core wire lumen 1015 and optional solder or glue holes 1017 to facilitate attaching the sensor mount 412 to a core wire or forming strip as described above. Also visible are the core wire lumen 1015, the fixed portion 214 of the sensor 112, the diaphragm or sensing element 1012, the cantilever portion 1016 of the sensor 112, and the sensor cantilever recess 540.

[0101] Thus, an electrical connection (e.g., for transmitting power and signals) can be provided between the wire or filament 230a and the flow sensor 113 without requiring the wire or filament 230a to extend directly from the connecting portion 114 to the flow sensor 113 by extending alongside the pressure sensor mount 412. In addition, as described above, the two electrical pathways defined by the wire or filament 230a are shared between the pressure sensor 112 and the flow sensor 113.

[0102] Also visible is the detail area marked by the dashed rectangle, which will be Fig.15and Fig.16 Shown at a larger magnification.

[0103] Fig.15 According to various aspects of the present disclosure Fig.14 Schematic perspective view of detail area 1490 of sensor mount 412. Visible are sensor 112, sensor pad 1032, bonding wire or jumper 1330, wire or wire 230p, shared wire or wire 230a, proximal terminal 560 and core wire lumen 1015.

[0104] Fig.16 According to various aspects of the present disclosure Fig.14 Schematic top view of detail area 1490 of sensor mount 412. Visible are sensor 112, sensor pad 1032, bond wire or jumper 1330, wire or filament 230p, shared wire or filament 230a, and proximal terminal 560.

[0105] Fig.17 17 is a schematic diagram of a processor circuit 1750 according to aspects of the present disclosure. The processor circuit 1750 may be implemented in the intravascular sensing system 100 (e.g., PIM 304, processing system 306) or other devices or workstations (e.g., third-party workstations, servers, etc.) as needed, or on a cloud processor or other remote processing unit to implement the method. As shown, the processor circuit 1750 may include a processor 1760, a memory 1764, and a communication module 1768. These elements may communicate directly with each other or indirectly, for example, via one or more buses.

[0106] The processor 1760 may include any combination of a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller or a general purpose computing device, a reduced instruction set computing (RISC) device, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other related logic devices (including mechanical and quantum computers). The processor 1760 may also include another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 1760 may also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in cooperation with a DSP core, or any other such configuration.

[0107] Memory 1764 may include cache memory (e.g., cache memory of processor 1760), 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 disk, solid-state memory device, hard disk drive, other forms of volatile and non-volatile memory, or a combination of different types of memory. In one embodiment, memory 1764 includes a non-transitory computer-readable medium. Memory 1764 may store instructions 1766. Instructions 1766 may include instructions that, when executed by processor 1760, cause processor 1760 to perform the operations described herein. Instructions 1766 may also be referred to as code. The terms "instructions" and "code" should be broadly interpreted to include any type of computer-readable statements. For example, the terms "instructions" and "code" may refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" may include a single computer-readable statement or many computer-readable statements.

[0108] The communication module 1768 may include any electronic circuit and / or logic circuit to facilitate direct or indirect communication of data between the processor circuit 1750 and / or other processors or devices. In this regard, the communication module 1768 may be an input / output (I / O) device. In some examples, the communication module 1768 facilitates direct or indirect communication between the processor circuit 1750 and / or various elements of the intraluminal sensing system 100. The communication module 1768 can communicate within the processor circuit 1750 through a variety of methods or protocols. Serial communication protocols may include, but are not limited to, United States Serial Protocol Interface (USSPI), Inter-Integrated Circuit Bus (I2C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio Equipment Company 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol. Parallel protocols may include, but are not limited to, Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), a Universal Synchronous Receiver Transmitter (USART), or other suitable subsystems.

[0109] External communications (including but not limited to software updates, firmware updates, or readings from the intraluminal device) can be accomplished using any suitable wireless or wired communication technology, such as a cable interface (such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or a cellular data connection (e.g., 2G / GSM (Global System for Mobile Communications), 3G / UMTS (Universal Mobile Telecommunications System), 4G, Long Term Evolution (LTE), WiMax, or 5G). For example, a Bluetooth low energy (BLE) radio can be used to establish a connection with a cloud service, transfer data, and receive software patches. The controller can be configured to communicate with a remote server or a local device (e.g., a laptop, tablet, or handheld device), or may include a display capable of displaying state variables and other information. Information can also be transferred to a physical medium (e.g., a USB flash drive or memory stick).

[0110] Thus, it can be seen that a sensor mount with embedded conductors advantageously enables electrical signals to be transmitted from a wire located proximal to the sensor mount to a wire or other conductor located distal to the sensor mount without requiring the wire to be laid adjacent to the sensor mount as is typically done. Thus, for a combined intraluminal physiological sensing device that includes more than one sensor, a sensor mount for one of the sensors may include conductive material that transmits signals for a different sensor. This arrangement can simplify the design, manufacturing, and assembly process of the intraluminal device, can reduce the likelihood of manufacturing defects, can reduce costs, can reduce device diameter, and can help make the intraluminal sensing device more stable during handling and use.

[0111] The logical operations that constitute aspects of the technology described herein are variously referred to as operations, steps, objects, elements, components, or modules. In addition, it should be understood that these operations can be arranged or performed in any order, unless explicitly required otherwise, or the required language inherently requires a specific order. It should also be understood that the technology can be used for electrical and electronic devices for disposable and multiple use medical or non-medical purposes.

[0112] All directional references, such as up, down, inside, outside, upward, downward, left, right, side, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal and distal, are used for identification purposes only to assist the reader in understanding the claimed subject matter and do not create limitations, especially with respect to the location, orientation or use of the metal ink conductor assembly. References to connection, such as attaching, coupling, connecting and joining, are to be interpreted broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise stated. Thus, references to connection do not necessarily mean that two elements are directly connected and in a fixed relationship to each other. The term "or" should be interpreted as "and / or" rather than "exclusively or". Unless otherwise stated in the claims, the numerical values ​​stated should be interpreted as merely illustrative and should not be regarded as limiting. The word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. Unless otherwise stated in the claims, the stated numerical values ​​should be interpreted as illustrative only and should not be regarded as limiting.

[0113] The above specification, examples, and data provide a complete description of the structure and use of exemplary aspects of the metal ink conductor assembly as defined in the claims. Although various aspects of the claimed subject matter have been described above with a certain degree of specificity, or with reference to one or more individual aspects, those skilled in the art may make numerous modifications to the disclosed aspects without departing from the spirit or scope of the claimed subject matter.

[0114] Other aspects are also contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular aspects and not limiting. Modifications may be made in detail or structure without departing from the essential elements of the subject matter as defined in the following claims.

Claims

1. An intraluminal device, comprising: a flexible, elongated member configured for positioning within a body lumen of a patient, wherein the flexible, elongated member comprises a proximal portion and a distal portion; a first sensor positioned at the distal portion of the flexible elongated member; a second sensor positioned at the distal portion of the flexible elongated member; as well as a sensor mount positioned at the distal portion of the flexible elongated member, Wherein, the first sensor is positioned on the sensor mounting seat, wherein the second sensor is spaced apart from the first sensor, and Wherein, the sensor mount includes a first material, the first material is electrically conductive and is configured to transmit an electrical signal associated with the second sensor.

2. The intraluminal device according to claim 1, in, The first sensor includes a first intraluminal modality, and Wherein, the second sensor comprises a second different intraluminal modality.

3. The intraluminal device according to claim 2, in, The first sensor includes a pressure sensor, and Wherein, the second sensor comprises a flow sensor.

4. The intraluminal device according to claim 1, in, The sensor mount includes a second material forming an outer surface of the sensor mount, Wherein, in a cross section, the second material completely surrounds the conductive first material.

5. The intraluminal device according to claim 4, in, the second material is electrically conductive, wherein the sensor mount comprises a third material disposed between the first material and the second material, Wherein, the third material includes an electrically insulating material.

6. The intraluminal device according to claim 5, wherein: In the cross section, the third material completely surrounds the first material.

7. The intraluminal device according to claim 1, in, The sensor mount includes a proximal portion and a distal portion, wherein the first material extends between the proximal portion and the distal portion.

8. The intraluminal device according to claim 7, wherein: The first sensor overlaps the first material along a length of the sensor mount.

9. The intraluminal device according to claim 1, in, A majority of the first material is embedded within the sensor mount, and The first material includes a first exposed portion and a second exposed portion.

10. The intraluminal device according to claim 9, wherein: The intraluminal device further comprises: a connector region positioned at the proximal portion of the flexible elongated member; a first wire coupled to the first exposed portion and the second sensor; and A second wire is coupled to the second exposed portion and the connector region so that the second sensor is in electrical communication with the connector region.

11. The intraluminal device according to claim 12, wherein: The intraluminal device also includes a third electrical wire coupled to the first sensor and the connector region such that the first sensor is in electrical communication with the connector region.

12. The intraluminal device according to claim 9, wherein: The intraluminal device further comprises: a connector region positioned at the proximal portion of the flexible elongated member; a first wire coupled to the first exposed portion and the second sensor; a bonding wire coupled to the second exposed portion and the first sensor; and A second electrical wire is coupled to the first sensor and the connector region so that the first sensor and the second sensor are in electrical communication with the connector region.

13. The intraluminal device according to claim 9, wherein: The first exposed portion and the second exposed portion are continuous with an outer surface of the sensor mount.

14. A device comprising: an intravascular guidewire configured to be positioned within a blood vessel of a patient; a flow sensor positioned at the distal end of the intravascular guidewire; a pressure sensor positioned proximal to the flow sensor such that the pressure sensor is spaced apart from the distal end of the intravascular guidewire; a pressure sensor mounting seat, wherein the pressure sensor is positioned on the pressure sensor mounting seat; a connector region positioned at a proximal portion of the intravascular guidewire; as well as A flow signal path extends between the flow sensor and the connector area, wherein the flow signal path is configured to transmit an electrical signal associated with the flow sensor, wherein a portion of the flow signal path includes a conductive material that forms part of the structure of the pressure sensor mount.

15. The device according to claim 14, wherein: The device also includes: A pressure signal path extends between the pressure sensor and the connector region, wherein the pressure signal path is configured to transmit an electrical signal associated with the pressure sensor.

Images