Spacer for sensor in intraluminal sensing device

Abstract

An endoluminal device includes a flexible elongate member configured for extension within a body lumen of a patient; and a sensor disposed at the distal region of the flexible elongate member and configured to obtain intraluminal data associated with the body lumen. The housing at least partially surrounds the sensor. The spacer is located between a portion of the sensor housing and the proximal side of the sensor, and includes: a base; a through hole extending through the base; a recess disposed distal to the base and at least partially surrounded by the sidewall; a plurality of support protrusions protruding from the side wall and configured to contact a proximal surface of the sensor; and at least one retention feature extending distally from at least one support tab of the plurality of support tabs and configured for contacting a side surface of the sensor.

Description

Technical Field

[0001] The subject matter described herein relates to a spacer that fits within a sensor housing for a physiological sensing intraluminal device. The sensor spacer has particular, but not exclusive, utility for intravascular catheters and guidewires. Background Art

[0002] Coronary artery disease (CAD) is one of the leading causes of death in the world. To address this problem, image-guided therapy (IGT) utilizes various imaging modalities (e.g., coronary angiography) and in vivo diagnostic devices (e.g., pressure sensing guidewires or intravascular ultrasound catheters). Small-diameter medical devices such as intraluminal (e.g., intravascular) catheters and guidewires may contain sensors (e.g., pressure, temperature, flow, or imaging sensors), and the power and communication of these sensors are achieved by electrical conductor bundles. However, recent guidewire devices may have a diameter of 360 microns or less in some cases. The current construction of such devices may require manual welding / joining of micro cables / wires to the sensors. In addition, the subassemblies consisting of sensors and wires may be quite fragile, and if not installed correctly, there may be a risk of electrical short circuits against the conductive sensor housing. Even at high magnifications, manually assembling these components may also be extremely challenging, resulting in a high scrap rate.

[0003] The information included in this background section of the 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 to be limited. Summary of the invention

[0004] Blood velocity sensing guidewires can be used, for example, to assess non-obstructive coronary artery disease (NOCAD) and microvascular disease (MVD). The present disclosure provides a spacer mounted within a sensor housing and located between a sensor and a tapered region within the sensor housing. For example, microscale 3D printing can be used to create a spacer to be placed between the proximal side of the sensor and the distal side of the sensor housing to control the position and orientation of the sensor relative to the sensor housing. The sensor spacer (1) limits the depth to which the sensor can travel within the sensor housing; (2) helps align the sensor so that the distal surface of the sensor is orthogonal to the longitudinal axis of the sensor housing; (3) centers the sensor within the sensor housing; and (4) prevents the proximal end of the sensor from electrically shorting against the conductive material of the sensor housing. Therefore, the sensor spacer facilitates a more robust assembly process with less risk of scrapping. The sensor spacer described herein has specific but non-exclusive utility for intraluminal medical catheters and guidewires (e.g., intravascular catheters and multiple catheters).

[0005] One general aspect includes an intraluminal device. The intraluminal device includes: a flexible, elongated member configured to extend in a longitudinal direction within a body lumen of a patient; a sensor disposed at a distal region of the flexible, elongated member, wherein the sensor is configured to obtain intraluminal data associated with the body lumen; a housing at least partially surrounding the sensor; and a spacer disposed between a portion of the sensor housing and a proximal side of the sensor. The spacer includes: a base; a through hole extending through the base; a recess disposed distally of the base and at least partially surrounded by a sidewall extending distally from the base, wherein the sidewall is configured to not contact a proximal surface of the sensor; a plurality of support protrusions protruding radially inwardly from the sidewall and configured to contact a proximal surface of the sensor; and at least one retaining feature extending distally from at least one of the plurality of support protrusions and configured to contact a side surface of the sensor.

[0006] Embodiments may include one or more of the following features. In some embodiments, the spacer is configured to center the sensor within the sensor housing relative to the longitudinal axis of the sensor housing. In some embodiments, the spacer is configured to control the depth of the sensor within the sensor housing along the longitudinal axis of the sensor housing. In some embodiments, the spacer is configured to control the alignment of the sensor relative to the longitudinal axis of the sensor housing. In some embodiments, the spacer includes a first polymer material. In some embodiments, the sensor is attached to the spacer by a second polymer material at least partially positioned in the recess. In some embodiments, the spacer is attached to the sensor housing by a third polymer material in contact with the proximal surface of the spacer. In some embodiments, the intraluminal device also includes at least two wires that extend distally through the through hole and are fixedly attached to the sensor and electrically connected to the sensor. In some embodiments, at least one retaining feature includes a plurality of lugs, wherein each lug in the plurality of lugs extends distally from one of the plurality of support lobes. In some embodiments, the retaining feature includes a sidewall or a countersunk hole of the sidewall.

[0007] One general aspect includes a method for assembling an intraluminal device. The method includes: obtaining a flexible, elongated member configured to extend in a longitudinal direction within a body lumen of a patient; positioning a sensor housing at a distal region of the flexible, elongated member; positioning a spacer within the sensor housing; positioning a sensor at least partially within the sensor housing, distal to the spacer, wherein the sensor is configured to obtain intraluminal data associated with the body lumen, wherein the spacer includes: a base; a through hole extending through the base; a recess disposed above the base and at least partially surrounded by a sidewall extending distally from the base, wherein the sidewall is configured to not contact a proximal surface of the sensor; a plurality of support protrusions projecting radially inwardly from the sidewall and configured to contact a proximal surface of the sensor; and at least one retaining feature extending distally from at least one of the plurality of support protrusions and configured to contact a side surface of the sensor.

[0008] Embodiments may include one or more of the following features. In some embodiments, the spacer is configured to center the sensor within the sensor housing relative to the longitudinal axis of the sensor housing. In some embodiments, the spacer is configured to control the depth of the sensor within the sensor housing along the longitudinal axis of the sensor housing. In some embodiments, the spacer is configured to control the alignment of the sensor relative to the longitudinal axis of the sensor housing. In some embodiments, the spacer includes a first polymer material. In some embodiments, the method further includes attaching the sensor to the spacer by a second polymer material at least partially positioned in the recess. In some embodiments, the method further includes attaching the spacer to the sensor housing by a third polymer material in contact with the proximal surface of the spacer. In some embodiments, at least two wires are fixedly attached to the sensor and electrically connected to the sensor. In some embodiments, at least one retaining feature includes a plurality of protrusions, wherein each of the plurality of protrusions extends distally from one of the plurality of supporting protrusions. In some embodiments, the retaining feature includes a sidewall or a countersunk hole of the sidewall. Implementations of the described technology may include hardware, methods or processes, or computer software on a computer-accessible medium. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of these methods.

[0009] This Summary is provided to introduce in a simplified form a selection of concepts that will be further described in the Detailed Description section 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 presentation of features, details, utilities, and advantages of the flow measurement system as defined in the claims is provided in the following written description of various embodiments of the present disclosure and illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0011] Figure 1 is a diagrammatic side view of an intravascular sensing system including an intravascular device including a multi-filar electrical conductor bundle according to aspects of the present disclosure.

[0012] Figure 2 is a perspective view of an example sensor for an intravascular device according to aspects of the present disclosure.

[0013] Figure 3 is a perspective view of an example sensor assembly 300 in accordance with at least one embodiment of the present disclosure.

[0014] Figure 4 is a perspective view of at least some components of an example sensor assembly in accordance with at least one embodiment of the present disclosure.

[0015] Figure 5 is a perspective cross-sectional view of at least a portion of a sensor assembly 300 according to at least one embodiment of the present disclosure.

[0016] Figure 6 is a side cross-sectional view of at least a portion of an example sensor assembly 300 in accordance with at least one embodiment of the present disclosure.

[0017] Figure 7 is a perspective view of an example sensor mounted within an example sensor spacer in accordance with at least one embodiment of the present disclosure.

[0018] Figure 8 is a perspective view of an example sensor spacer in accordance with at least one embodiment of the present disclosure.

[0019] Fig. 9 is a top view of an example sensor spacer in accordance with at least one embodiment of the present disclosure.

[0020] Fig.10 is a side cross-sectional view of an example sensor spacer in accordance with at least one embodiment of the present disclosure.

[0021] Fig.11is a perspective view of an alternative embodiment of a sensor spacer in accordance with at least one embodiment of the present disclosure.

[0022] Fig.12 According to at least one embodiment of the present disclosure Figure 6 A perspective cross-sectional view of a second polymer material.

[0023] Fig.13 is a schematic diagram of a processor circuit according to at least one embodiment of the present disclosure.

[0024] Fig.14 is a schematic diagram in the form of a flow chart of an example method 1400 for assembling an intraluminal sensing device in accordance with at least one embodiment of the present disclosure. DETAILED DESCRIPTION

[0025] Coronary artery disease (CAD) is one of the leading causes of death in the world. To address this problem, image-guided therapy (IGT) imaging systems (e.g., for coronary angiography) and physical diagnostic devices (e.g., pressure sensing guidewires or intravascular ultrasound catheters) can be used. One such diagnostic device is a blood velocity sensing guidewire, which can be used, for example, to assess non-obstructive coronary artery disease (NOCAD) and microvascular disease (MVD). These guidewires are equipped with a single-element ultrasonic transducer at their distal end. The transducer can transmit ultrasonic waves in a forward-looking direction and receive corresponding pulse-echo signals. By pulsed wave (PW) Doppler analysis, the blood velocity distribution in a specific sample volume can be derived.

[0026] Existing sensor assemblies may include multiple manual assembly steps that require high dexterity and skill to perform, even at high magnifications. Currently, the location at which the transducer is positioned within the housing depends on the volume and shape of the adhesive backing layer on the proximal side of the transducer. These adhesive volumes may be too small to be consistently controlled, and therefore the depth and angle of the transducer relative to the housing may vary. This results in the transducer requiring plasma cleaning and parylene coating to prevent electrical shorts, and difficulty in achieving a specified matching layer thickness, which may require a re-grinding process. Inconsistencies in the matching layer may ultimately lead to greater variations in the sensitivity and electrical performance of the sensor.

[0027] The disclosed sensor spacer includes: a base for limiting the depth of the transducer in the housing, the base having a through hole for the conductive lead to pass through; a recessed portion for allowing a backing adhesive of known thickness to be applied to the transducer; a protrusion for mounting the transducer while limiting the contact area between the transducer and the spacer to reduce the possibility of negatively affecting the acoustic performance; and a centering feature for controlling the concentricity between the transducer and the housing.

[0028] The disclosed sensor spacer may improve the consistency of the transducer's position within the housing during assembly.A 3D printing method known as two-photon polymerization is known from academic research, and its ability to produce parts with sub-micron precision is well suited for applications with tight tolerances.

[0029] The present disclosure provides a spacer that fits between a cavity within a sensor housing and a distal surface of a sensor. The sensor spacer (1) limits the depth to which the sensor can travel within the sensor housing; (2) helps align the sensor so that the distal surface of the sensor is orthogonal to the longitudinal axis of the sensor housing; (3) centers the sensor within the sensor housing; and (4) prevents the proximal end of the sensor from electrically shorting against the conductive material of the sensor housing. As a result, this improved sensor assembly design can be significantly more robust than existing systems, with components more difficult to damage during assembly, handling, or use. The sensor spacer can be produced, for example, by single-component or multi-component additive manufacturing (e.g., 3D printing) and can include retaining features to receive a sensing element (e.g., an ultrasonic transducer) while minimizing the contact area between the sensor and the sensor spacer (e.g., limited to 5-10% of the surface area of ​​the sensor).

[0030] The present disclosure greatly facilitates the manufacture and assembly of intraluminal sensing systems. When implemented on an ultrasonic guidewire that communicates with a processor, the sensor housing or sensor assembly disclosed herein provides spacers between multiple parts of the sensor and multiple parts of the sensor housing. This improved design converts the cumbersome, skill-intensive guidewire assembly process into a process that can be performed in less time with less knowledge, less training, less manual dexterity, and less error, without the need to check each finished assembly to properly position and align the sensor in the sensor housing. The conventional routine. This unconventional approach improves the function of the flow sensing guidewire by reducing the possibility of manufacturing errors.

[0031] These descriptions are provided for exemplary purposes only and should not be considered to limit the scope of the sensor spacer.Some features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0032] In order to promote the 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 these embodiments. However, it should be understood that it is not intended to limit the scope of the present disclosure. Any changes and further modifications to the described devices, systems and methods and any further applications of the principles of the present disclosure are fully contemplated and included in the present disclosure, as would be normally expected by a person skilled in the art in the field to which the present disclosure relates. Specifically, it is fully contemplated that the features, components and / or steps described for one embodiment can be combined with the features, components and / or steps described for other embodiments of the present disclosure. In addition, although the following description may involve blood vessels, it should be understood that the present disclosure is not limited to such applications. For example, the devices, systems and methods described herein can be used in any body chamber or body lumen, including the esophagus, vein, artery, intestine, ventricle, atrium or any other body lumen and / or chamber. However, for the sake of brevity, multiple repetitions of these combinations will not be described separately.

[0033] Figure 1 1 is a schematic side view of an intravascular sensing system 100 according to aspects of the present disclosure, the intravascular sensing system including an intravascular device 102 including a multi-wire electrical conductor bundle 230. The intravascular device 102 may be an intravascular guidewire that is sized and shaped for positioning within a patient's blood vessel. The intravascular device 102 may include a distal tip 108 and a sensing component or sensor 112. The sensor 112 may be an electronic sensor, an electromechanical sensor, a mechanical sensor, an optical sensor, and / or other suitable types of sensors. For example, the sensor 112 may be a flow sensor configured to measure blood flow velocity within a patient's blood vessel, a pressure sensor configured to measure the pressure of blood flowing within the blood vessel, or another type of sensor including but not limited to a temperature sensor or an imaging sensor. For example, the flow data obtained by the flow sensor may be used to calculate a physiological variable, such as a coronary flow reserve (CFR). The pressure data obtained by the pressure sensor may be used, for example, to calculate a physiological pressure ratio (e.g., FFR, iFR, Pd / Pa, or any other suitable pressure ratio). The imaging sensor may include an intravascular ultrasound (IVUS), intracardiac echocardiography (ICE), optical coherence tomography (OCT), or intravascular photoacoustic (IVPA) imaging sensor. For example, the imaging sensor may include one or more ultrasound transducer elements, including an array of ultrasound transducer elements.

[0034] The intravascular device 102 includes a flexible elongated member 106. A sensor 112 is disposed at a distal portion 107 of the flexible elongated member 106. In some embodiments, the sensor 112 may be mounted at the distal portion 107 and within a housing 280. A flexible end coil 290 extends distally from the housing 280 at the distal portion 107 of the flexible elongated member 106. A connecting portion 114 located at the proximal end of the flexible elongated member 106 includes conductive portions 132, 134. In some embodiments, the conductive portions 132, 134 may be conductive inks printed and / or deposited around the connecting portion 114 of the flexible elongated member 106. In some embodiments, the conductive portions 132, 134 are conductive metal rings positioned around the flexible elongated member. A locking section is formed by a neck 118, and the neck 118 and a knob 120 are disposed at a proximal portion 109 of the flexible elongated member 106.

[0035] Figure 1 The intravascular device 102 in the embodiment includes a distal core wire 210 and a proximal core wire 220. The distal core 210 and the proximal core 220 are metal components that form part of the body of the intravascular device 102. For example, the distal core 210 and the proximal core 220 are flexible metal rods that provide structure to the flexible slender member 106. The diameter of the distal core 210 and the proximal core 220 can vary along their length. The joint between the distal core 210 and the proximal core 220 is surrounded and contained by a hypotube 215.

[0036] In some embodiments, the intravascular device 102 includes a distal assembly and a proximal assembly electrically and mechanically connected together, which provide electrical communication between the sensor 112 and the conductive portions 132, 134. For example, flow data obtained by the sensor 112 (in this example, the sensor 112 is a flow sensor) can be transmitted to the conductive portions 132, 134. Control signals (e.g., operating voltages, start / stop commands, etc.) from a processor system 306 in communication with the intravascular device 102 can be transmitted to the sensor 112 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 112, a multi-wire conductor bundle 230, and / or one or more layers of insulating polymer / plastic 240 surrounding the conductive members 230 and the core 210. For example, the polymer / plastic layer can insulate and protect the conductive members of the multi-wire cable or conductor bundle 230. The proximal subassembly may include a proximal core 220. The proximal subassembly may also include one or more polymer layers 250 (hereinafter referred to as polymer layers 250) surrounding the proximal core 220 and / or a conductive tape 260 embedded in one or more insulating and / or protective polymer layers 250. In some embodiments, 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, the flexible elongated member may refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220, etc.) and / or one or more components of the distal subassembly (e.g., including the distal core 210, etc.). The joint between the proximal core 220 and the distal core 210 is surrounded by a hypotube 215.

[0037] In various embodiments, the intravascular device 102 may include one, two, three, or more core wires extending along its length. For example, in one embodiment, a single core wire extends substantially along the entire length of the flexible elongated member 106. In such embodiments, the locking segment 118 and the segment 120 may be integrally formed at a proximal portion of the single core wire. The sensor 112 may be secured at a distal portion of the single core wire. In other embodiments, such as Figure 1In the illustrated embodiment, the locking segment 118 and the segment 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 in a multi-wire conductor bundle 230 that communicates with the sensor 112. For example, the conductor bundle 230 may include one or more wires that are directly connected to the sensor 112. In some cases, the conductive member 230 is electrically and mechanically coupled to the sensor 112 by, for example, welding. In some cases, the conductor bundle 230 includes two or three wires (e.g., a two-wire cable or a three-wire cable). The individual wires may include a bare metal conductor or a metal conductor surrounded by one or more insulating layers. The multi-wire conductor bundle 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 or helically wrapped around the entire length of the distal core 210 or a portion of the length of the distal core 210.

[0038] Intravascular device 102 includes one or more conductive strips 260 at the proximal portion of flexible elongated member 106. Conductive strips 260 are embedded within polymer layer 250. Conductive strips 260 are in direct communication with conductive portions 132 and / or 134. In some cases, multi-wire conductor bundle 230 is electrically and mechanically coupled to sensor 112 by, for example, welding. In some cases, conductive portions 132 and / or 134 include conductive ink (e.g., metal nano-ink, such as silver or gold nano-ink) deposited or printed directly on conductive strips 260.

[0039] As described herein, electrical communication between the conductive member 230 and the conductive ribbon 260 may be established at the connection portion 114 of the flexible elongated member 106. By establishing electrical communication between the conductor bundle 230 and the conductive ribbon 260, the conductive portions 132, 134 may be in electrical communication with the sensor 112.

[0040] In by Figure 1 In some embodiments shown, the intravascular device 102 includes a locking segment 118 and a segment 120. To form the locking segment 118, a machining process is required to remove the polymer layer 250 and the conductive tape 260 in the locking segment 118 and to shape the proximal core 220 in the locking segment 118 into a desired shape. Figure 1 As shown, locking segment 118 includes a reduced diameter, while segment 120 has a diameter substantially similar to the diameter of proximal core 220 in connection portion 114. In some cases, because the machining process removes the conductive tape in locking segment 118, the proximal end of conductive tape 260 will be exposed to moisture and / or liquids, such as blood, saline solution, disinfectant, and / or enzymatic cleaning solution, and thus an insulating layer 158 is formed on the proximal portion of connection portion 114 to insulate the exposed conductive tape.

[0041] In some embodiments, connector 314 provides an electrical connection between conductive portions 132, 134 and a patient interface module or patient interface monitor 304. In some cases, patient interface monitor (PIM) 304 may be connected to a console or processing system 306 that includes or communicates with a display 308. In some embodiments, patient interface monitor 304 includes signal processing circuitry, such as analog-to-digital converters (ADCs), analog and / or digital filters, signal conditioning circuitry, and any other suitable signal processing circuitry for processing signals provided by sensor 112 for use by processing system 306.

[0042] System 100 can be deployed in a catheterization lab having a control room. Processing system 306 can be located in the control room. Alternatively, processing system 306 can be located elsewhere, such as in the catheterization lab itself. The catheterization lab can include a sterile field, and its associated control room may or may not be sterile, depending on the operation to be performed and / or the medical facility. In some embodiments, device 102 can be controlled from a remote location such as a control room, thereby not requiring an operator to be in close proximity to the patient.

[0043] The intraluminal device 102, PIM 304, and display 308 may be communicatively coupled to a processing system 306, directly or indirectly. These elements may be communicatively coupled to the medical processing system 306 via a wired connection, such as a standard copper multi-wire conductor bundle 230. The processing system 306 may be communicatively coupled to one or more data networks, such as a TCP / IP-based local area network (LAN). In other embodiments, different protocols may be utilized, such as a synchronous optical network (SONET). In some cases, the processing system 306 may be communicatively coupled to a wide area network (WAN).

[0044] The PIM 304 transmits the received signals to a processing system 306 where the information is processed and displayed on a display 308. The console or processing system 306 may include a processor and a memory. The processing system 306 may be operable to facilitate the features of the intravascular sensing system 100 described herein. For example, the processor may execute computer readable instructions stored on a non-transitory tangible computer readable medium.

[0045] The PIM 304 facilitates signal communication between the processing system 306 and the intraluminal device 102. In some embodiments, the PIM 304 performs preliminary processing of the data before relaying the data to the processing system 306. In examples of such embodiments, the PIM 304 performs amplification, filtering, and / or aggregation of the data. In one embodiment, the PIM 304 also supplies high-voltage and low-voltage DC power via the multi-wire conductor bundle 230 to support the operation of the intraluminal device 102.

[0046] The multi-wire cable or transmission bundle 230 may include multiple conductors, including one, two, three, four, five, six, seven or more conductors. The multi-wire conductor bundle 230 may be positioned along the exterior of the distal core 210. The multi-wire conductor bundle 230 and the distal core 210 may be coated with an insulating and / or protective polymer 240. Figure 1 In the example shown, the multi-wire conductor bundle 230 includes: two straight sections 232 and 236, where the multi-wire conductor bundle 230 extends linearly and parallel to the longitudinal axis 103 of the flexible slender member 106 on the outside of the distal core 210; and a spiral or convoluted section 234, where the multi-wire conductor bundle 230 is wound around the outside of the distal core 210. In some embodiments, the multi-wire conductor bundle 230 includes only straight sections or only spiral or convoluted sections. In general, the multi-wire conductor bundle 230 can extend in a linear, winding, non-linear or non-winding manner or any combination thereof. Communication along the multi-wire conductor bundle 230 (if any) can be carried out by a variety of methods or protocols (including serial, parallel and other methods), wherein one or more wires of the bundle 230 carry signals. One or more wires of the multi-wire conductor bundle 230 can also carry direct current (DC) power, alternating current (AC) power, or serve as an electrical ground connection.

[0047] The display or monitor 308 can be a display device such as a computer monitor, a touch screen display, a television screen, or any other suitable type of display. The monitor 308 can be used to display selectable prompts, instructions, and visual representations of imaging data to the user. In some embodiments, the monitor 308 can be used to provide the user with an operation-specific workflow to complete the intraluminal imaging operation.

[0048] Before continuing, it should be noted that the above examples are provided for purposes of illustration and are not intended to be limiting. Other devices and / or device configurations may be utilized to perform the operations described herein.

[0049] Figure 2 is a schematic cross-sectional view of an example sensor assembly 251, which may be included, for example, in Figure 1 In the intravascular device 102. More specifically, Figure 2A sensor assembly 251 is shown, which includes a sensing component or sensor 112, a housing 280, and an acoustic matching layer 252. Figure 1 As shown in the illustrated positions of the sensing component 112 and the housing 280, 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 112 faces distally.

[0050] like Figure 2 As shown, the sensing component 112 is positioned within the housing 280 and includes a proximal surface 270, an opposite distal surface 272, and a side surface 274. In some embodiments, one or more of the proximal surface 270, the distal surface 272, or the side surface 274 may be covered in an insulating layer 276. The insulating layer 276 may be formed, for example, of polyparaxylene that 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 112 and the housing 280, which may be formed of metal. As used herein, unless otherwise noted, in embodiments where the distal end of the sensing component 112 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 112 is covered by the insulating layer 276, reference to the proximal surface 270 encompasses the insulating layer, and in embodiments where the side of the sensing component 112 is covered by the insulating layer 276, reference to the side surface 274 encompasses the insulating layer. As described herein, aspects of the sensor spacer advantageously position the sensor 112 relative to the housing 280 such that the possibility of shorting is minimized or eliminated. In some aspects, as a result of using the sensor spacer described herein, the insulating layer 276 can be omitted.

[0051] In some embodiments, the sensing component or sensor 112 may include a transducer element, such as an ultrasonic transducer element, located on a distal surface 272, such that the transducer element faces distally and can be used by the sensing component 112 to obtain sensor data corresponding to structures distal to the sensing component 112. The sensing component 112 may additionally or alternatively include a transducer element located on a proximal surface 270, 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 a side surface 274 of the sensing component 112 (e.g., on a perimeter or circumference). In some embodiments, the transducer and its associated electrodes and electrical connection points may form the entire sensing component 112, such that all surfaces of the sensing component 112 include the transducer.

[0052] As further shown, the sensing component 112 is coupled to the multi-wire conductor bundle 230, and at least a portion (e.g., a distal portion) of the multi-wire conductor bundle 230 extends through the housing 280. In some embodiments, the multi-wire conductor bundle 230 and the sensing component 112 can be physically (e.g., mechanically) coupled. In addition, one or more wires (e.g., conductive members) of the multi-wire conductor bundle 230 can be electrically coupled (e.g., in electrical communication) with the sensing component 112. Specifically, one or more wires of the multi-wire conductor bundle 230 can be coupled to an element of the sensing component 112, such as a transducer (e.g., an ultrasonic transducer), and can provide power, control signals, electrical grounding or signal return, etc. to the element. As described above, such an element can be positioned on the distal surface 272 of the sensor. In this regard, in some embodiments, one or more wires of the multi-wire conductor bundle 230 can extend through a cutout or hole in the sensing component 112 (e.g., at least in the proximal surface 270) 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-wire conductor bundle 230 may terminate at and / or be electrically coupled to the proximal surface 270 of the sensing component 112 (e.g., coupled to elements on the proximal surface 270). Furthermore, in some embodiments, for example, a subset of the wires of the multi-wire conductor bundle 230 may extend to the distal surface 272 and / or be electrically coupled to elements located at the distal surface 272, while a different subset of the wires may be electrically coupled to elements at the proximal surface 270.

[0053] In some embodiments, the multi-filar conductor bundle 230 may be covered in an insulating layer 276. In some embodiments, for example, the multi-filar conductor bundle 230 and the sensing component 112 may be coupled together to be presented as a subassembly and then positioned in the housing 280. In such embodiments, the insulating layer 276 may be applied (e.g., coated and / or deposited) over the entire subassembly, thereby creating an insulating layer 276 on both the sensing component 112 and the multi-filar conductor bundle 230.

[0054] In some embodiments, the acoustic matching layer 252 may be positioned on (e.g., above) the distal surface 272 of the sensing component 112. Specifically, the acoustic matching layer 252 may be disposed directly on the sensing component 112, or the acoustic matching layer 252 may be disposed on an insulating layer 276 covering the sensing component 112. 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 at least a portion of a conductive wire of a multi-wire conductor bundle 230 in communication with the transducer element (such as a wire extending through a hole or along a side of the sensing component 112). To this end, the acoustic matching layer 252 may contact and / or at least partially surround that portion of the conductive wire and / or transducer element. In addition, the acoustic matching layer 252 may provide acoustic matching to the sensing component 112 (e.g., to an ultrasonic transducer of the sensing component 112). For example, the acoustic matching layer 252 can minimize the acoustic impedance mismatch between the ultrasonic transducer and the sensed medium, such as 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, such as a polymer or adhesive, to provide acoustic matching with the sensing component 112. 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 270. In addition, the acoustic matching layer 252 can be applied to the sensing component 112 during assembly of the sensor assembly 251 before or after the sensing component 112 is positioned within the housing 280. 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 270 can be included in the sensor assembly 251 in the same or different steps. Furthermore, in addition to the one or more materials forming the acoustic matching layer 252 , the acoustic matching layer 252 may provide an acoustic match to the sensing component 112 via one or more dimensions of the acoustic matching layer 252 .

[0055] In some embodiments, the sensor assembly 251 may include an atraumatic tip such as Figure 1The distal tip 108 shown. 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 by 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 112. In some embodiments, the distal tip 108 may also cover the distal end 272 of the shell 280. 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 112 may be positioned within the shell 280 (e.g., surrounded by a continuous surface of the shell).

[0056] Figure 3 is a perspective view of an example sensor assembly 300 according to at least one embodiment of the present disclosure. The sensor assembly includes a sensor housing 280, a cable or conductor bundle 230, and a sensor, sensing component or transducer 112. Figure 3 In the example shown, the sensor housing 280 includes a helical cutout region 360 that facilitates threading the coil 290 onto the proximal end of the sensor housing 280 (see Figure 1 The cable or conductor bundle 230 includes insulated wires, conductors or leads 310, 320 and 330. The lead 320 extends through a central lumen 340 in the sensor 112 to form a distal connection 350 with a distal face of the sensor 112.

[0057] Figure 4 is a perspective view of at least some components of an example sensor assembly according to at least one embodiment of the present disclosure. Visible are sensor housing 280 and sensor electrical subassembly 440. Sensor housing 280 is formed by a hypotube 410 including a central lumen 420. Sensor housing 280 also includes a sensor cavity 412 connected to central lumen 420 by a tapered region 430. The sensor electrical subassembly (which may be colloquially referred to as a "tadpole" in some cases) includes electrical conductors 310, 320, and 330 and sensor or transducer 112. As previously described in Figure 3 As seen in FIG. 1 , the guide wire 320 extends through the sensor central lumen 340 to form a distal connection 350 with the distal surface of the sensor or transducer 112 .

[0058] In order to form Figure 3For example, the assembly technician may place a polymer material 460 (e.g., an adhesive or potting material) on the proximal side of the sensor 112 and / or in the sensor cavity 412 of the sensor housing 280. The assembly technician may then pull the wires 310, 320, and 330 through the sensor cavity 412, the tapered region 430, and the central lumen 420 of the housing 280 until the sensor 112 is seated in the sensor cavity 412.

[0059] During this process, it may be difficult to control the amount of polymer material 460, the depth of the sensor 112 within the sensor cavity 412, the centering of the sensor 112 within the sensor cavity 412, and the alignment of the sensor 112. Variations in these parameters may result in corresponding variations in the performance of the finished device. For example, if the sensor 112 is positioned too deep within the sensor cavity 412, the acoustic matching layer 252 (see Figure 2 ) may be thicker, resulting in a weaker output from the sensor and a weaker return echo into the sensor. Similarly, if the sensor 112 is misaligned within the sensor cavity 412, the acoustic pulses emitted by the sensor 112 may also be misaligned, resulting in reduced accuracy of the flow measurement. In extreme cases, if the proximal side of the sensor 112 contacts the hypotube 410 within the tapered region 430, or if the side of the sensor 112 contacts the hypotube 410 within the sensor cavity 412, the sensor 112 may form an electrical short circuit with the conductive material of the hypotube 410, which may degrade the performance of the sensor 112 or prevent the sensor 112 from functioning at all.

[0060] As shown below Figures 5 to 12 As shown, the introduction of a spacer between the sensor 112 and the housing 280 can significantly reduce the risk and / or occurrence of these problems.

[0061] Figure 5 is a perspective cutaway view of at least a portion of sensor assembly 300 according to at least one embodiment of the present disclosure. Visible are hypotube 410, hypotube central lumen 420, wires 310, 320, and 330, sensor 112, sensor central lumen 340, acoustic matching layer 252, and distal sensor connection 350. However, in Figure 5In the example shown, the sensor spacer 510 is positioned within the sensor cavity 412 and between the proximal side of the sensor 112 and the proximal end 520 of the sensor cavity 412. The sensor spacer 510 limits the depth to which the sensor 112 can be pulled into the sensor cavity 412 during the assembly process and thus prevents the proximal side of the sensor 112 from shorting against the proximal end of the sensor cavity 412. In addition, as shown below, the features of the sensor spacer 510 help center the sensor 112 within the sensor cavity 412, thereby preventing the sides of the sensor 112 from shorting against the inner wall 530 of the sensor cavity 412. Because the spacer centers the sensor and prevents physical contact between the sensor and the housing, the process of coating the sensor / wire assembly with parylene, which is used in part for electrical insulation, can also be eliminated, so similar electrically insulating coatings can also be eliminated. In addition, controlling the depth of the sensor in the housing can result in an improved ability to achieve a consistent thickness of the acoustic matching layer on the distal side of the sensor in a later manufacturing process, which can improve or make the electrical and acoustic performance of the finished product more consistent. This improved consistency can reduce or eliminate the need to calibrate individual guidewires relative to individual connectors, which can advantageously reduce the risk of a medical procedure in which a surgeon may replace a guidewire without replacing the connector (and thereby invalidate or defeat the calibration between the guidewire and the connector, and potentially result in unacceptably high power output to / from a sensor in the body). The sensor spacer 510 can be made, for example, of a polymer (e.g., a photopolymer material such as Nanoscribe IP-S) or another electrically insulating material, and can be selected to have an acoustic impedance within a range that will reflect or absorb ultrasonic energy emitted by the sensor 112 so as not to interfere with the normal acoustic performance of the sensor 112.

[0062] Figure 6is a side cross-sectional view of at least a portion of an example sensor assembly 300 according to at least one embodiment of the present disclosure. Visible are hypotube 410, hypotube central lumen 420, wires 310, 320, and 330, sensor 112, sensor central lumen 340, acoustic matching layer 252, distal sensor connection 350, and sensor spacer 510. Also visible is a proximal sensor connection 610 formed between the wire 310 and the proximal side of sensor 112. Sensor 112 can be a transducer, such as a single transducer element. Sensor 112 can obtain ultrasound data representing blood flow velocity. In some aspects, the ultrasound data obtained by sensor 112 does not provide an image of a blood vessel. In one example, sensor 112 is made of a piezoelectric material such as lead zirconate titanate (PZT), such that when a voltage is applied between distal sensor connection 350 and proximal sensor connection 610, the piezoelectric material compresses, and when the voltage is released, the piezoelectric material expands. This expansion can generate an acoustic pulse. Similarly, when an acoustic wave impinging on the sensor electronics 112 briefly compresses the piezoelectric material, a voltage is generated between the distal sensor connection 350 and the proximal sensor connection 610. In this manner, the sensor electronics 112 can send and receive pulses of ultrasonic energy. However, it should be understood that the sensor electronics can be of different types, including but not limited to capacitive micromachined ultrasonic transducers (CMUTs), piezoelectric micromachined ultrasonic transducers (PMUTs), optical transceivers, or others.

[0063] The sensor spacer may be made, for example, of a first polymer material. The sensor 112 is held in place within the sensor spacer 510 by a second polymer material 620, such as an adhesive or potting compound. The second polymer material may be or include an acoustic backing material, such as Nuvasil acoustic backing adhesive, but other example materials may include, but are not limited to, Dymax 1184, Dymax 9001, or similar photopolymers, parylene, etc., and may be selected, for example, to have an acoustic impedance in a range that will reflect or absorb ultrasonic energy emitted by the sensor electronics 112 so as not to interfere with the operation of the sensor electronics 112. In general, the acoustic backing material attenuates ultrasonic energy, thereby preventing ultrasonic propagation in undesirable directions (e.g., from the sensor proximally in this example). In some embodiments, the second polymer material 620 may be selected for mechanical and adhesive properties, as it may be used to provide strain relief to the wires or conductive leads 310, 320 and secure the transducer assembly (e.g., sensor electronics 112 and spacer 510) into the housing 280, and may also be selected as a suitable acoustic matching layer distal to the transducer or sensor electronics 112. Figure 6In the example shown, the second polymer material 620 fills the space between the sensor electronics 112 and the sensor spacer 510 , as well as fills a portion of the sensor central lumen 340 not occupied by the wire 320 .

[0064] The third polymer material 460 contacts the proximal side 640 of the sensor spacer 510 and at least partially fills the tapered region 430 of the hypotube 410 to attach the sensor spacer 510 to the sensor housing 280. Figure 6 In the example shown, the third polymer material 460 also at least partially fills the space between the sides of the sensor element 112 and the inner wall of the sensor cavity 412. Example materials may include, but are not limited to, Loctite Nuva-Sil silicone potting compound or other potting compounds, and may be selected, for example, to have an acoustic damping effect on ultrasonic energy emitted by the sensor electronics 112 so as not to interfere with the operation of the sensor electronics 112. Depending on the implementation, the third polymer material 460 may be the same or different from the second polymer material 620, and may be the same or different from the material of the acoustic matching layer 252. In general, an acoustic matching layer is used to promote ultrasonic propagation in a desired direction (in this example, distally from the sensor).

[0065] Figure 7 is a perspective view of an example sensor electronics 112 assembled within an example sensor spacer 510 in accordance with at least one embodiment of the present disclosure. Visible are the sensor or sensor electronics 112, the sensor spacer 510, and the sensor central lumen 340. Figure 7 In the example shown, the sensor spacer 510 includes three retention tabs 710 evenly spaced around the perimeter of the sensor spacer 510. The retention tabs 710 extend vertically along a portion of the side of the sensor electronics 112 to center the sensor electronics 112 within the sensor spacer 510, and therefore also within the sensor cavity of the sensor housing.

[0066] Figure 8 is a perspective view of an example sensor spacer 510 according to at least one embodiment of the present disclosure. The disclosed sensor spacer 510 includes: a base 810, which is used to limit the depth of the transducer in the housing and has a through hole 890 for the wire 320 to pass through (see Figure 6 ); a recess 870 for allowing a backing adhesive of known thickness to be applied to the transducer; a plurality of support protrusions 840 for mounting the transducer while limiting the contact area between the transducer and the spacer to reduce the possibility of negatively affecting acoustic performance; and a protrusion 710 that serves as a centering feature to control the concentricity between the transducer and the housing.

[0067] A 3D printing method known as two-photon polymerization is known to be able to produce components with sub-micron precision. Thus, the sensor spacer 510 may be made at least in part from a cured photopolymer formed on a two-photon polymerization 3D printer (e.g., a Nanoscribe GT2 or UpNanoNanoOne), but may also be produced, for example, on a high-resolution ultraviolet digital light processing (UV DLP) 3D printer (e.g., a Boston Micro Fabrication microArch 230) or by micromachining or other semiconductor manufacturing techniques or by other means. For example, if made via microinjection molding, the sensor spacer 510 may be made of alternative materials and have a higher volume. Such a sensor spacer 510 may be implemented in other small ultrasound devices to improve consistency and manufacturability without negatively affecting performance.

[0068] Some existing sensor assemblies include a polymer material (e.g., adhesive) surrounding the sensor 112. Once cured, the polymer material can be solid. However, the precise shape and size of such a cured adhesive mass is difficult to control, resulting in inconsistent depth, centering, and alignment of the sensor 112 within the sensor housing 280. The sensor spacer 510 differs from this technology at least in that it is manufactured as a solid object with sub-micron precision.

[0069] exist Figure 8 In the example shown, the tab 710 includes a stress relief chamfered area 820 at the lower corner. The tab 710 protrudes vertically from the edge 830 of the side wall 850. The widened portion of the edge 830 forms a support protrusion 840. The sensor spacer 510 is configured so that the sensor 112 (see Figure 7 ) rests on the support protrusion 840 and by keeping the tab 710 centered without contacting other portions of the edge 830. Thus, the contact between the sensor 112 and the sensor spacer 510 can be limited to only 5-10% of the surface area of ​​the sensor. This can limit the impact of the sensor spacer 510 on the acoustic performance of the sensor.

[0070] In one example, the floor or distal surface 880 of the recess 870 (which is also the top or distal surface of the base 810) is bonded to the backing adhesive 620 (see Figure 6 ) is in contact with the backing adhesive 620, which is also in contact with the proximal surface of the sensor 112 to secure the sensor 112 within the sensor spacer 510. Similarly, the bottom or proximal surface 640 of the sensor spacer 510 is in contact with the adhesive 460 (see Figure 6 ) to secure the sensor spacer 510 to the sensor housing 280 (see Figure 6 )Inside.

[0071] Fig. 9 8 is a top view of an example sensor spacer 510 in accordance with at least one embodiment of the present disclosure. Visible are tab 710, edge 830 of sidewall 850, support protrusion 840, backing adhesive recess 870, recess floor 880, and through hole 890. Fig. 9 In the example shown, the recess 870 has a generally triangular shape so that the support protrusion 840 is radially inward of the rest of the sidewall edge 830. Therefore, the sensor spacer 510 (see Figure 8 ) has a diameter D such that the sensor electronics 112 (see Figure 7 ) is supported by the support protrusion 840, but does not contact other portions of the sidewall edge 830. It should be understood that other shapes of the recess 870 and / or other numbers, sizes or shapes of the protrusions 710 may be used instead without departing from the spirit of the present disclosure. Fig. 9 those shown in or as Fig. 9 A supplement to those shown in .

[0072] Fig.10 According to at least one embodiment of the present disclosure, Fig. 9 10. A side cross-sectional view of an example sensor spacer 510 taken along section line 10-10 of FIG. Visible are tab 710, rim 830 of side wall 850, support protrusion 840, backing adhesive recess 870, recess floor 880, through hole 890, and bottom or proximal surface 640. In one example, the diameter D of sensor spacer 510 is between 250 and 350 microns ± 1 micron, and the height H of the sensor spacer is between 50 and 100 microns ± 1 micron, although other heights and diameters, both larger and smaller, may be used alternatively or additionally. In one example, diameter D may be selected to be approximately 5 microns less than the nominal width of sensor cavity 412, leaving a circumferential gap of approximately 2.5 microns between sensor spacer 510 and sensor cavity 412, although other gaps may be sized. Both larger and smaller sizes may be used alternatively or additionally. Also important is the longitudinal distance between the proximal side 640 of the sensor spacer 510 and the support protrusion 840, as this controls the depth of the transducer or sensor electronics within the sensor housing.

[0073] Fig.11 is a perspective view of an alternative embodiment of a sensor spacer 510 in accordance with at least one embodiment of the present disclosure. Fig.11 In the example shown, there is no tab, and the edge 830 of the side wall 850 has been raised to the height of the tab, or raised enough to hold the sensor 112 (see Figure 7) and centered at different heights while maintaining the contact area between the sensor spacer 510 and the sensor 112 below a desired threshold (e.g., below 5% or 10% of the surface area of ​​the sensor 112). Also visible are the recess 870, the recess floor 880, the through hole 890, and the bottom or proximal surface 860. In some embodiments, the retaining feature can be a counterbore in the sidewall, rather than the sidewall itself. For example, the distal portion of the sidewall can be counterbored to thin the sidewall, and the thinned portion of the sidewall can serve as a retaining feature. Other retaining features that contact the side of the sensor 112 may alternatively or additionally be used without departing from the spirit of the present disclosure.

[0074] Fig.12 According to at least one embodiment of the present disclosure Figure 6 A perspective cross-sectional view of the second polymer material 620. When the sensor spacer 510 and the sensor 112 (see Figure 6 ), the second polymer material 620 may flow between the sensor spacer 510 and the sensor 112 so that the first portion 1210 of the second polymer material 620 fills the through hole 890 of the sensor spacer 510 (see Figure 8 ), the second portion 1220 of the second polymer material 620 fills the recess 870 of the sensor spacer 510 (see Figure 8 ), and the third portion 1230 of the second polymer material 620 fills the central lumen 340 of the sensor 112 (see Figure 7 ). When the second polymer material surrounds the wire 320 (see Figure 6 ) flows through the first region 1210, the second region 1220, and the third region 1230 of the second polymer material 620 to form a longitudinal axis 103 (see Figure 1 ) through hole.

[0075] Fig.13 1 is a schematic diagram of a processor circuit 1350 according to at least one embodiment of the present disclosure. The processor circuit 1350 can be implemented in the intravascular sensing system 100, the processing system 306, or other devices or workstations (e.g., third-party workstations, network routers, etc.) or on a cloud processor or other remote processing unit as needed to implement the devices, systems, and methods disclosed herein. As shown, the processor circuit 1350 may include a processor 1360, a memory 1364, and a communication module 1368. These elements can communicate directly with each other or indirectly, for example, via one or more buses.

[0076] The processor 1360 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 1360 may also include another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 1360 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 combined with a DSP core, or any other such configuration.

[0077] Memory 1364 may include cache memory (e.g., cache memory of processor 1360), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In one embodiment, memory 1364 includes a non-transitory computer-readable medium. Memory 1364 may store instructions 1366. Instructions 1366 may include instructions that, when executed by processor 1360, cause processor 1360 to perform the operations described herein. Instructions 1366 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, processes, etc.

[0078] The communication module 1368 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect data communication between the processor circuit 1350 and other processors or devices. In this regard, the communication module 1368 may be an input / output (I / O) device. In some cases, the communication module 1368 facilitates direct or indirect communication between the processor circuit 1350 and / or various elements of the intravascular measurement system 100. The communication module 1368 may communicate within the processor circuit 1350 via a variety of methods or protocols. Serial communication protocols may include, but are not limited to, US SPI, I / O, and SPI. 2C, RS-232, RS-485, CAN, Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a UART, USART, or other appropriate subsystem.

[0079] External communications (including but not limited to software updates, firmware updates, preset sharing between the processor and the central server, or readings from the ultrasound device) can be implemented using any suitable wireless or wired communication technology, such as a cable interface (such as a USB, micro-USB, Lightning, or FireWire interface), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or a cellular data connection (such as 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G). For example, a Bluetooth low energy (BLE) radio can be used to establish a connection with a cloud service for transmitting data and for receiving software patches. The controller can be configured to communicate with a remote server or a local device (such as a laptop, tablet, or handheld device), or may include a display capable of showing state variables and other information. Information can also be transmitted on a physical medium such as a USB flash drive or memory stick.

[0080] Fig.14 is a schematic diagram in the form of a flow chart of an example method 1400 for assembling an intraluminal sensing device in accordance with at least one embodiment of the present disclosure. It should be understood that the steps of method 1400 may be performed in the same manner as described above. Fig.14 The steps shown may be performed in different orders, additional steps may be provided before, during, or after the steps, and / or some of the steps described may be replaced or eliminated in other embodiments. Flowcharts and block diagrams are provided herein for exemplary purposes; those of ordinary skill in the art will recognize numerous variations that still fall within the scope of the present disclosure.

[0081] At step 1410 , the method includes obtaining a flexible elongate member, such as a catheter or guidewire, configured for insertion into a body lumen of a patient.

[0082] At step 1420, the method includes positioning a sensor housing at or near a distal end of the flexible elongated member.

[0083] At step 1430, the method includes placing the sensor spacer 510 (see Figure 8 ) is positioned within a sensor housing as described above.

[0084] At step 1440 , the method includes positioning a polymer material, such as an adhesive or potting compound, on the distal surface of the sensor spacer, as described above.

[0085] At step 1450 , the method includes positioning the sensor within the sensor housing such that a proximal surface of the sensor is in contact with the sensor spacer.

[0086] Therefore, it can be seen that the present disclosure improves the operation and assembly process of flow sensing guidewire devices and systems by providing components that center, align and control the depth of the sensor within the sensor housing, while preventing the sensor from being electrically shorted against the conductive material of the sensor housing.

[0087] The present disclosure may, for example, be implemented as a flow sensing guidewire for providing simultaneous pressure and flow information, such as the Philips FloWire (Doppler guidewire) or the Philips ComboWire TM It may also be applied to new flow modalities being developed, both for existing devices and for devices developed hereafter, with a single transducer or multiple transducers, and including flow sensors only or in combination with pressure sensors or with other sensing modalities.

[0088] The spacer can be detected non-destructively by using high resolution CT scanning, or destructively by precise sectioning of the device and observing the cross section of the sensor area under a microscope. Due to the small size and location within the housing, the sensor is unlikely to be detected by less technical methods. The sensor spacer can be incorporated into devices such as flow sensing guidewires, other guidewires (e.g., pressure sensing guidewires), or other small scale transducer applications or ultrasound devices.

[0089] Many variations on the above examples and embodiments are possible. For example, one or more surfaces of the sensor spacer may include a coating, such as a hydrophobic, hydrophilic, scratch resistant or other coating. The surface of the sensor spacer may be plasma treated to increase adhesion. Some components shown as conductive may also function if made of an insulator, and vice versa. Figure 6 and Fig.12 The polymer material 620 shown in can be introduced as a curable liquid or gel, or can be a solid material component that is assembled in place as part of the assembly process. The adhesive or potting compound can be selected based on their mechanical, electrical, or acoustic properties. The acoustic matching layer can be replaced with an optically transparent or translucent material or a material that is transparent to other types of radiation, the acoustic backing layer can be replaced with an optically reflective or optically absorptive material or a material that is reflective or absorptive to other types of radiation, and the sensor can be replaced with an optical transmitter, an optical sensor, or other type of sensor.

[0090] The logical operations that make up the embodiments of the technology described herein are variously referred to as operations, steps, objects, elements, components, or modules. It should be understood that these can be arranged or performed in any order unless otherwise explicitly stated or the claim language inherently requires a specific order or arrangement. It should also be understood that the described technology can be used in single-use and multiple-use electrical and electronic devices for medical or non-medical use.

[0091] All directional references (e.g., up, down, inside, outside, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal and distal) are used for identification purposes only to help the reader understand the claimed subject matter and do not create limitations, especially with respect to the location, orientation or use of sensor spacers. Connection references (e.g., attachment, connection, connection and engagement) should be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements, unless otherwise specified. Therefore, connection references do not necessarily mean that two elements are directly connected and are in a fixed relationship to each other. The term "or" should be interpreted as meaning "and / or" rather than "exclusive or". The word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. Unless otherwise indicated in the claims, the values ​​stated should be interpreted as merely illustrative and should not be considered restrictive.

[0092] The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the sensor spacer as defined in the claims. Although various embodiments of the claimed subject matter have been described above with a certain degree of specificity or with reference to one or more individual embodiments, those skilled in the art may make numerous changes to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter.

[0093] Other embodiments 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 the particular embodiments and not limiting. Changes may be made in detail or structure without departing from the essential elements of the subject matter defined in the appended claims.

Claims

1. An intraluminal device, comprising: a flexible, elongated member configured to extend in a longitudinal direction within a body lumen of a patient; a sensor disposed at a distal region of the flexible elongated member, wherein the sensor is configured to obtain intraluminal data associated with the body lumen; a housing at least partially surrounding the sensor; as well as a spacer disposed between a portion of the sensor housing and a proximal side of the sensor, wherein the spacer comprises: base; a through hole extending through the base; a recess disposed distally of the base and at least partially surrounded by a sidewall extending distally from the base, wherein the sidewall is configured to not contact a proximal surface of the sensor; and A plurality of support protrusions project radially inwardly from the sidewall and are configured to contact a proximal surface of the sensor.

2. The intraluminal device according to claim 1, wherein: The spacer includes at least one retention feature extending distally from at least one support protrusion of the plurality of support protrusions and configured to contact a side surface of the sensor.

3. The intraluminal device according to claim 1, wherein: The spacer is configured to center the sensor within the sensor housing relative to a longitudinal axis of the sensor housing.

4. The intraluminal device according to claim 1, wherein: The spacer is configured to control a depth of the sensor within the sensor housing along a longitudinal axis of the sensor housing or an alignment of the sensor relative to the longitudinal axis of the sensor housing.

5. The intraluminal device according to claim 1, wherein: The spacer includes a first polymer material.

6. The intraluminal device according to claim 1, wherein: The sensor is attached to the spacer by a second polymer material at least partially positioned within the recess.

7. The intraluminal device according to claim 1, wherein: The spacer is attached to the sensor housing by a third polymer material in contact with a proximal surface of the spacer.

8. The intraluminal device according to claim 1, wherein: The intraluminal device also includes at least two wires extending distally through the through-hole and fixedly attached to and electrically coupled with the sensor.

9. The intraluminal device according to claim 2, wherein: The at least one retention feature includes a plurality of tabs, each tab of the plurality of tabs extending distally from one of the plurality of support protrusions.

10. The intraluminal device according to claim 2, wherein: The at least one retaining feature comprises the sidewall or a counterbore in the sidewall.

11. A method for assembling an intraluminal device, the method comprising: obtaining a flexible elongated member configured to extend in a longitudinal direction within a body lumen of a patient; positioning a sensor housing at a distal region of the flexible elongated member; positioning a spacer within the sensor housing; as well as Positioning a sensor at least partially within the sensor housing distal to the spacer, wherein the sensor is configured to obtain intraluminal data associated with the body lumen, wherein the spacer comprises: base; a through hole extending through the base; a recess disposed on the base and at least partially surrounded by a sidewall extending distally from the base, wherein the sidewall is configured to not contact a proximal surface of the sensor; and A plurality of support protrusions project radially inwardly from the sidewall and are configured to contact the proximal surface of the sensor.

12. The method according to claim 11, wherein: The spacer also includes at least one retention feature extending distally from at least one support protrusion of the plurality of support protrusions and configured to contact a side surface of the sensor.

13. The method according to claim 11, wherein: The spacer is configured to center the sensor within the sensor housing relative to a longitudinal axis of the sensor housing.

14. The method according to claim 11, wherein: The spacer is configured to control a depth of the sensor within the sensor housing along a longitudinal axis of the sensor housing or an alignment of the sensor relative to the longitudinal axis of the sensor housing.

15. The method according to claim 11, wherein: The spacer includes a first polymer material.

16. The method according to claim 11, wherein: The method also includes attaching the sensor to the spacer via a second polymer material at least partially positioned within the recess.

17. The method according to claim 11, wherein: The method also includes attaching the spacer to the sensor housing via a third polymer material in contact with a proximal surface of the spacer.

18. The method according to claim 11, wherein: The method also includes proximally drawing at least two wires through the through-hole prior to positioning the spacer within the sensor housing, wherein the at least two wires are fixedly attached to and electrically coupled to the sensor.

19. The method according to claim 12, wherein: The at least one retention feature includes a plurality of tabs, each tab of the plurality of tabs extending distally from one of the plurality of support protrusions.

20. The method according to claim 12, wherein: The at least one retaining feature comprises the sidewall or a counterbore in the sidewall.

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