Continuous electrical tracing in endoluminal devices and related devices, systems and methods - Patents.com

Abstract

The device includes an intravascular guidewire including a flexible elongate member configured to be disposed within a patient's blood vessel. The flexible elongate member includes a proximal portion and a distal portion. The proximal portion includes a proximal corewire and the distal portion includes a distal corewire. The intravascular guidewire includes a sensor disposed on the distal portion of the flexible elongate member. The sensor is configured to acquire medical data related to the blood vessel while the flexible elongate member is disposed within the blood vessel. The intravascular guidewire includes a connector disposed on the proximal portion of the flexible elongate member. The intravascular guidewire includes a conductive member that establishes electrical communication between the sensor and the connector. The conductive member is continuous between the sensor and the connector.

Description

[Technical field]

[0001] The subject matter described herein relates to an intraluminal physiological sensing device (e.g., an intravascular pressure sensing and / or flow sensing guidewire). For example, the intraluminal device may include a continuous electrical trace between a distal sensor and a proximal electrical connector. [Background technology]

[0002] Existing intravascular guidewires with sensors have fine gauge electrical wires that provide the transmission of electrical signals for the sensors. The manufacture of such devices can include many steps that involve a human operator or machine contacting the fine gauge electrical wire. Due to its delicate nature, the fine gauge electrical wire is susceptible to damage as a result of such contact. For example, the conductor itself may break and the insulation may be damaged. This reduces or eliminates the electrical connectivity of the sensor. In addition, the fine gauge electrical wire typically has a circular cross-section that occupies a space with a very small outer diameter of the guidewire. Furthermore, existing intravascular guidewires may require soldering to make electrical connections between different conductors that extend along different portions of the length. This creates an opportunity for failure at these connections and prevents the electrical signal from the sensor from being received at the proximal connector.

[0003] The information contained in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included solely for technical reference purposes and should not be considered as subject matter on which the scope of the present disclosure should be limited. Summary of the Invention [Problem to be solved by the invention]

[0004] An opportunity for failure is presented in the connection that may prevent the electrical signal from the sensor from being received at the proximal connector. [Means for solving the problem]

[0005] An intraluminal physiological sensing device (e.g., intravascular pressure sensing and / or flow sensing guidewire) is disclosed that includes a conductive member for power and signal communication. Examples of conductive members include electrical traces formed with conductive ink, metal deposition, electroplating, three-dimensional printed conductive polymers or metals, and / or extruded conductive materials. The conductive member may be applied in a thinner layer that reduces the size (thickness) of the electrical connection, facilitating central placement of the distal core within the wire body and eliminating surface irregularities. The sensor is electrically connected using a bonding process and additional bonding material. The conductive member may be directly connected to the sensor or sensor mount without the need for an additional bonding process that requires additional force on the sensor. This advantageously provides a more robust electrical connection since there are no solder joints between multiple electrical conductors. This ensures that the electrical signal from the sensor is received at the proximal connector, allowing medical professionals to have intravascular pressure and / or flow information to make decisions about the patient's health care, resulting in improved health outcomes for the patient. Additionally, because ribbons and / or multifilamentary conductor bundles can cause uneven storage of energy and uneven stiffness, resulting in localized torque during use of the guidewire or catheter, the straightness, flexibility, and torque response of intraluminal devices having conductive members can be improved as well.

[0006] The electrically conductive member assemblies disclosed herein have particular utility for, but are not limited to, intraluminal medical catheters, guidewires, or guide catheters.

[0007] In an exemplary aspect, a device is provided that includes an intravascular guidewire having a flexible elongate member configured to be disposed within a patient's blood vessel, the flexible elongate member having a proximal portion and a distal portion, the proximal portion having a proximal corewire and the distal portion having a distal corewire, a sensor disposed on the distal portion of the flexible elongate member, the sensor configured to acquire medical data related to the blood vessel while the flexible elongate member is disposed within the blood vessel, a connector disposed on the proximal portion of the flexible elongate member, and a conductive member establishing electrical communication between the sensor and the connector, the conductive member being continuous between the sensor and the connector.

[0008] In some aspects, the distal portion of the conductive member is directly coupled to the sensor. In some aspects, the connector comprises a conductive band, and the proximal portion of the conductive member is directly coupled to the conductive band. In some aspects, the intravascular guidewire comprises a plurality of conductive members that establish electrical communication between the sensor and the connector, and each conductive member of the plurality of conductive members is continuous between the sensor and the connector. In some aspects, the distal portion of the proximal core wire is coupled to the proximal portion of the distal core wire at a location along the length of the flexible elongate member, and the conductive member is continuous across the location. In some aspects, the location comprises a tubular member, and the distal portion of the proximal core wire and the proximal portion of the distal core wire are disposed inside the tubular member, and the conductive member is disposed outside the tubular member. In some aspects, the flexible elongate member further comprises a first polymer layer disposed over the proximal and distal core wires, and the first polymer layer is configured to provide insulation of the conductive member from the proximal and distal core wires. In some aspects, the intravascular guidewire further comprises a sensor mount, the sensor coupled to the sensor mount, and the first polymer layer disposed over the sensor mount. In some aspects, the first polymer layer has an opening exposing the sensor. In some aspects, the flexible elongate member further comprises a second polymer layer disposed over the conductive member. In some aspects, the flexible elongate member further comprises a hydrophilic coating disposed over the second polymer layer. In some aspects, in cross section, the conductive member is completely surrounded by at least one of the first polymer layer or the second polymer layer. In some aspects, the conductive member comprises electrical traces. In some aspects, the electrical traces comprise at least one of a conductive ink, metal deposition, electroplating, three-dimensional printing conductive polymer or metal, or extruded conductive material. In some aspects, the sensor comprises at least one of a pressure sensor or a flow sensor.

[0009] In an exemplary aspect, a device is provided that includes an intravascular guidewire having a flexible elongate member configured to be disposed within a patient's blood vessel, the flexible elongate member having a proximal portion and a distal portion, the proximal portion having a proximal core wire and the distal portion having a distal core wire, the proximal core wire being coupled to the distal core wire at a location along the length of the flexible elongate member, at least one of a pressure sensor or a flow sensor disposed at a distal portion of the flexible elongate member configured to obtain at least one of pressure data or flow data, respectively, while the flexible elongate member is disposed within the blood vessel, a connector disposed at a proximal portion of the flexible elongate member, and a conductive ink trace establishing electrical communication between the sensor and the connector, the conductive ink trace being continuous between the sensor and the connector including traversing said location.

[0010] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. 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 the features, details, utilities, and advantages of the metallic ink conductor assembly as defined in the claims is provided in the following written description of various aspects of the disclosure and illustrated in the accompanying drawings.

[0011] Exemplary aspects of the present invention will now be described with reference to the accompanying drawings. [Brief description of the drawings]

[0012] [Figure 1] 1 is a schematic top view of an intravascular device, according to aspects of the present disclosure. [Diagram 2] 1 is a schematic side view of an intravascular sensing system including an intravascular device, according to an aspect of the present disclosure. [Figure 3A] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 3B] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 3C] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 3D] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 3E] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 3F] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 3G] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 3H] 1 is a schematic cross-sectional top view of an intravascular device according to aspects of the present disclosure. [Figure 4] 1 is a schematic diagram of an intravascular device according to an aspect of the present disclosure. [Diagram 5] 1 is a schematic diagram of a sensor mount / housing coupled to a distal core of an intravascular device, according to an aspect of the present disclosure. [Figure 6] 1 is a schematic diagram of a first polymer coating applied to an intravascular device according to an embodiment of the present disclosure. [Figure 7] 1 is a schematic diagram of an intravascular device exposing a portion of a sensor mount / housing according to an aspect of the present disclosure. [Figure 8] 1 is a schematic diagram of mounting a sensor to a sensor mount / housing of an intravascular device, according to an aspect of the present disclosure. [Figure 9] 1 is a schematic top view of a sensor of an intravascular device according to aspects of the present disclosure. [Figure 10] 1 is a schematic diagram of applying one or more conductive layers along the length of an intravascular device 102, according to an embodiment of the present disclosure. [Figure 11] 1 is a schematic diagram of one or more conductive layers coupled to one of one or more electrical contact pads and a sensor of an intravascular device according to an embodiment of the present disclosure. [Figure 12] 12 shows a cross-sectional view of the intravascular device of FIG. 11 as seen along section line AA taken therein, according to an embodiment of the present disclosure. [Figure 13]1 is a schematic diagram of applying a second polymer coating applied to an intravascular device, according to an embodiment of the present disclosure. [Figure 14] 1 is a schematic diagram of a second polymer coating applied to a distal core of an intravascular device, according to an embodiment of the present disclosure. [Figure 15] 1 is a schematic diagram of applying a conductive portion to an intravascular device, according to an aspect of the present disclosure. [Figure 16] 16 shows a cross-sectional view of the intravascular device of FIG. 15 as seen along section line BB taken therein, according to an embodiment of the present disclosure. [Figure 17] 16 shows a cross-sectional view of the intravascular device of FIG. 15 as seen along line of section CC taken therein, according to an embodiment of the present disclosure. [Figure 18] 12 shows a cross-sectional view of the intravascular device of FIG. 11 as seen along section line AA taken therein, according to an embodiment of the present disclosure. [Figure 19] 1 illustrates a cross-sectional view of an intravascular device according to an aspect of the present disclosure. [Figure 20] 1 illustrates a cross-sectional view of an intravascular device according to an aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] A conductive member assembly is disclosed that provides improved electrical / mechanical performance for an endoluminal sensing device in an endoluminal system and eliminates manufacturing issues associated with conductive fillers. A multi-filler bundle (e.g., bi-filler or tri-filler) is a grouping or multiple (e.g., two or three) conductors, each surrounded by an insulating coating. During the manufacturing or assembly process of the endoluminal sensing device, the multi-filler bundle passes inside the hypotube in the hypotube joint area of ​​the endoluminal sensing device. The hypotube joint area includes five main elements / components, namely, the hypotube, the proximal core, the distal core, the multi-filler bundle, and the adhesive. Assembling the hypotube joint requires significant competence and skill from the worker assembling the hypotube joint. Having many components and parts to handle / assemble increases the chances of component damage and defective electrical signals. The multi-filler bundle is a very delicate component that is easily damaged during assembly since the multi-filler bundle needs to be fed through the inside of the hypotube.

[0014] Replacing the embedded filler with a conductive member that is placed outside of the hypotube and / or replaces the hypotube entirely allows for the use of conductive material applied in a thinner layer, which reduces the size (thickness) of the electrical connection, facilitates centering of the distal core within the wire body, and removes surface irregularities. The sensor is electrically connected using a bonding process and additional bonding material. The conductive member may be directly connected to the sensor or sensor mount without the need for an additional bonding process that requires additional force on the sensor. The straightness and torque response of an intraluminal device having a conductive member may also be improved, since the ribbon and / or multi-filler conductor bundle adds stiffness and local torque to the guidewire or catheter, which may lead to a reduction in mechanical whipping response when the device is manipulated within an intravascular anatomy. In some cases, whipping may also be referred to as jump torquing. Whipping occurs when the distal portion of the guidewire does not rotate smoothly relative to the proximal portion of the guidewire (e.g., controlled by the user), and instead, the distal portion of the guidewire rotates rapidly inside the blood vessel, releasing stored energy all at once to catch up with the rotational position of the proximal portion of the guidewire.

[0015] Other manufacturing issues may also be alleviated by using the conductive member assembly of the present disclosure. For example, in current manufacturing processes, the proximal end of the distal core and the distal end of the proximal core are reduced in diameter so that the multi-filar bundle fits inside the hypotube and allows enough space for the multi-filar bundle. This reduction in diameter makes this area of ​​the wire more likely to kink during bending / manipulation. By applying a conductive member to the outside of the hypotube or replacing the hypotube entirely with such a conductive member, the conductive member assembly reduces or eliminates these difficulties.

[0016] Example devices incorporating multi-filar conductor bundles and / or conductive ribbons include intraluminal medical guidewire devices such as those described in U.S. Pat. No. 10,595,820 B2, U.S. Patent Application Publication Nos. 2014 / 0187874, 2016 / 0058977, and 2015 / 0273187, and U.S. Provisional Patent Application No. 62 / 552,993 (filed Aug. 31, 2017), each of which is incorporated by reference herein as if fully set forth in its entirety.

[0017] These descriptions are provided for illustrative purposes only and should not be considered as limiting the scope of the metallic ink conductor assemblies. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0018] For purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the present disclosure is intended. Any changes and further modifications to the described devices, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one of ordinary skill in the art to which the present disclosure pertains, are fully contemplated and included within the present disclosure. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. Furthermore, although embodiments of the present disclosure may be described with respect to blood vessels, it will 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 tube, urethra, fallopian tube, intestine, colon, and / or any other suitable anatomical structure or body lumen. In other aspects, the devices, systems, and methods described herein may be used to inspect any number of anatomical locations and tissue types, including, but not limited to, organs including the liver, heart, kidneys, gallbladder, pancreas, lungs, ducts, intestines, brain, dural sac, spinal cord, and nervous system structures including peripheral nerves, urinary tract, and valves in blood vessels, ventricles, or other parts of the heart, and / or other tissues of the body. In addition to natural structures, the devices may be used to inspect artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices. However, for the sake of brevity, the numerous iterations of these combinations will not be described separately.

[0019] FIG. 1 is a schematic top view of an intravascular device 102 according to an embodiment of the present disclosure. The intravascular device 102 may be an intravascular, intraluminal, or intraluminal device, such as a guidewire, catheter, or guide catheter, sized and shaped for placement within a patient's blood vessel. The intravascular device 102 may include a sensor 112. For example, the sensor 112 may be a pressure sensor configured to measure the pressure of blood flow within the patient's blood vessel. The intravascular device 102 includes a flexible elongate member 106. The sensor 112 is disposed at a distal portion 107, also referred to as a distal subassembly, of the flexible elongate member 106. The sensor 112 may be attached to the distal portion 107 within a housing 280 in some embodiments. A flexible tip 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 elongate member 106. The connecting portion includes conductive portions 132, 134, 136. In some aspects, the conductive portions 132, 134, 136 may be conductive ink printed and / or deposited around the flexible elongate member 106. In some aspects, the conductive portions 132, 134, 136 may be conductive metal rings disposed around the flexible elongate member. The locking section 118 and the knob or retention section 120 are disposed on the proximal portion 109 of the flexible elongate member 106.

[0020] The intravascular device 102 of FIG. 1 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 elongate member 106. The diameters of the distal core 210 and the proximal core 220 that electrically and mechanically couple the distal core 210 to the proximal core 220 may vary along their lengths. The junction between the distal core 210 and the proximal core 220 that electrically and mechanically couples the distal core 210 to the proximal core 220 is surrounded and contained by a hypotube 215, which is a tubular member.

[0021] In some aspects, the intravascular device 102 includes a distal assembly and a proximal assembly that are electrically and mechanically joined together to provide electrical communication between the sensor 112 and the conductive portions 132, 134, 136. For example, pressure data acquired by the sensor 112 (in this example, the sensor 112 is a pressure sensor) may be transmitted to the conductive portions 132, 134, 136. Control signals from a computer in communication with the intravascular device 102 may 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, the conductive member 230, and / or one or more layers of insulating polymer / plastic 240 that surround the conductive member 230 and the 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 layers of polymer layer 250 (hereinafter polymer layer 250) surrounding proximal core 220 and / or conductive ribbons 260 embedded within one or more layers of polymer layer 250. In some aspects, the proximal subassembly and the distal subassembly may be manufactured separately. During the assembly process for intravascular device 102, the proximal subassembly and the distal subassembly may be electrically and mechanically joined together. As used herein, a flexible elongate member may refer to one or more components along the length of intravascular device 102, one or more components of the proximal subassembly (e.g., including proximal core 220), and / or one or more components of the distal subassembly (e.g., including distal core 210).

[0022] 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 along substantially the entire length of the flexible elongate member 106. In such aspects, the locking section 118 and the knob or retaining section 120 may be integrally formed on a proximal portion of the single core wire. The sensor 112 may be secured to a distal portion of the single core wire. In other aspects, such as illustrated in FIG. 1, the locking section 118 and the knob or retaining section 120 may be integrally formed on a proximal portion of the proximal core 220. The sensor 112 may be secured to a 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 members 230 may be one or more electrical wires in direct communication with the sensor 112. In some examples, the conductive member 230 is electrically and mechanically coupled to and in electrical communication with the sensor 112, for example, by soldering. In some examples, the conductive member 230 includes two or three electrical wires (e.g., a bifilar or trifilar cable). The individual electrical wires 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 helically wrapped around the distal core 210.

[0023] The intravascular device 102 includes one or more conductive ribbons 260 on a proximal portion of the flexible elongate member 106. The conductive ribbons 260 are embedded within the polymer layer 250. The conductive ribbons 260 are in direct communication with the conductive portions 132, 134, and / or 136. In some examples, the conductive member 230 is electrically and mechanically coupled to and in electrical communication with the sensor 112, for example, by soldering. In some examples, the conductive portions 132, 134, and / or 136 include a conductive ink (e.g., a metal nano-ink, such as a silver or gold nano-ink) that is deposited or printed on the conductive ribbons 260.

[0024] As described herein, electrical communication between the conductive member 230 and the conductive ribbon 260 may be established at a connection region 270 of the flexible elongate 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.

[0025] In some embodiments, as depicted by FIG. 1 , the intravascular device 102 includes a locking section 118 and a knob or retaining section 120. To form the locking section 118, a machining process is required to remove the polymer layer 250 and the conductive ribbon 260 in the locking section 118 and to shape the proximal core 220 in the locking section 118 into a desired shape. As shown in FIG. 1 , the locking section 118 includes a proposed diameter and the knob or retaining section 120 has a diameter substantially similar to the diameter of the proximal core 220 in the connecting portion 114. In some examples, since the machining process removes the conductive ribbon in the locking section 118, the proximal end of the conductive ribbon 260 is exposed to moisture and / or liquids, such as blood, saline, disinfectant, and / or enzymatic cleaning solutions, and an insulating layer 158 is formed over the proximal end portion of the connecting portion 114 to insulate the exposed conductive ribbon.

[0026] FIG. 2 is a schematic side view of an intraluminal (e.g., intravascular) sensing system 100 including an intravascular device 102 including a conductive member 230 (e.g., a multifilar conductor bundle) and a conductive ribbon 260, according to an embodiment of the present disclosure. The intravascular device 102 may be an intravascular guidewire sized and shaped for placement within a patient's blood vessel. The intravascular device 102 includes a distal end 108 and a sensor 113. For example, the sensor 113 may be a pressure sensor and / or a flow sensor configured to measure the pressure of blood flow within the patient's blood vessel, or another type of sensor including, but not limited to, a temperature sensor or an imaging sensor, or a combination sensor measuring more than one characteristic. For example, flow data acquired by the flow sensor may be used to calculate a physiological variable, such as coronary flow reserve (CFR). The intravascular device 102 includes a flexible elongate member 106. The sensor 113 is disposed at a distal portion 107 of the flexible elongate member 106. The sensor 113 may be mounted at the distal portion 107 within the housing 282 in some aspects. A flexible tip coil 290 extends distally from the housing 282 at the distal portion 107 of the flexible elongate member 106. A connecting portion 114 disposed at the proximal end of the flexible elongate member 106 includes conductive portions 132, 134. In some aspects, the conductive portions 132, 134 may be conductive ink printed and / or deposited around the connecting portion 114 of the flexible elongate member 106. In some aspects, the conductive portions 132, 134 may be metal bands or rings that are conductive and disposed around the flexible elongate member. A locking region is formed by a collar or locking section 118 and a knob or retaining section 120 disposed at the proximal portion 109 of the flexible elongate member 106.

[0027] The intravascular device 102 of FIG. 2 includes a core wire including a distal core 210 and a proximal core 220. In some examples, the distal core 210 and the proximal core 220 are metal components that form part of the body of the intravascular device 102. For example, the distal core 210 and the proximal core 220 may be flexible metal rods that provide structure for the flexible elongate member 106. The distal core 210 and / or the proximal core 220 may be made of a metal or metal alloy. For example, the distal core 210 and / or the proximal core 220 may be made of stainless steel, nitinol, titanium, nickel-cobalt-chromium-molybdenum alloy (e.g., MP35N), and / or other suitable materials. In some examples, the distal core 210 and / or the proximal core 220 may be made of hard graphite or a similar composite material. In some aspects, the distal core 210 and the proximal core 220 are made of the same material. In other embodiments, the distal core 210 and the proximal core 220 are made of different materials. The diameters of the distal core 210 and the proximal core 220 may vary along their respective lengths. The junction between the distal core 210 and the proximal core 220 is surrounded and housed by a hypotube 215. The sensor 113 may optionally be disposed at the distal end of the distal core 210.

[0028] In some aspects, the intravascular device 102 includes a distal subassembly and a proximal subassembly that are electrically and mechanically joined together to create electrical communication between the sensor 113 and the conductive portions 132, 134. For example, flow data acquired by the sensor 113 (in this example, the sensor 113 is a flow sensor) may be transmitted to the conductive portions 132, 134. In an exemplary aspect, the sensor 113 is a single ultrasonic transducer element. The transducer element emits an ultrasonic signal and receives echoes. The transducer element creates an electrical signal representative of the echo. A signal carrying filter carries this electrical signal from the sensor in the distal portion to a connector in the proximal portion. A processing system 306 processes the electrical signal to extract the fluid flow rate.

[0029] 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 sent 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, the conductive members 230, and / or one or more layers of insulating polymer / plastic 240 surrounding the conductive members 230 and the distal core 210. For example, the polymer / plastic layer may insulate and protect the conductive members of 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 polymer layers 250) surrounding the proximal core 220 and / or the conductive ribbons 260 embedded within one or more insulating layers and / or polymer layers 250. In some aspects, the proximal and distal subassemblies are manufactured separately. During the assembly process for the intravascular device 102, the proximal and distal subassemblies may be electrically and mechanically joined together. As used herein, a flexible elongate member may refer to one or more components along the length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220), and / or one or more components of the distal subassembly (e.g., including the distal core 210). Thus, a flexible elongate member may refer to the above-mentioned proximal and distal subassemblies combined. The joint between the proximal core 220 and the distal core 210 is surrounded by a hypotube 215, which is a tubular member.

[0030] 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 along substantially the entire length of the flexible elongate member 106. In such aspects, the locking section 118 and the knob or retaining section 120 may be integrally formed on a proximal portion of the single core wire. The sensor 113 may be secured to a distal portion of the single core wire. In other aspects, such as illustrated in FIG. 2, the locking section 118 and the knob or retaining section 120 may be integrally formed on a proximal portion of the proximal core 220. The sensor 113 may be secured to a distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 (e.g., a multifilar conductor bundle or cable) in communication with the sensor 113. For example, the conductive members 230 may be one or more electrical wires in direct communication with the sensor 113. In some examples, the conductive member 230 is electrically and mechanically coupled to and in electrical communication with the sensor 113, for example, by soldering. In some examples, the conductive member 230 includes two or three electrical wires (e.g., a bifilar or trifilar cable). The individual electrical wires may include bare metal conductors 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 helically wrapped around the distal core 210 to minimize or eliminate whipping of the distal core in tortuous anatomical structures.

[0031] The intravascular device 102 includes one or more conductive ribbons 260 on a proximal portion of the flexible elongate member 106. The conductive ribbons 260 are embedded within the polymer layer 250. The conductive ribbons 260 are in direct communication with the conductive portions 132 and / or 134. In some examples, the conductive member 230 is electrically and mechanically coupled to and in electrical communication with the sensor 113, for example, by soldering. In some examples, the conductive portions 132 and / or 134 include a conductive ink (e.g., a metal nano-ink, such as a copper, silver, gold, or aluminum nano-ink) that is deposited or printed on the conductive ribbon 260.

[0032] As described herein, electrical communication between the conductive member 230 and the conductive ribbon 260 may be established at the connecting portion 114 of the flexible elongate member 106. By establishing electrical communication between the conductive member 230 and the conductive ribbon 260, the conductive portions 132, 134 may be in electrical communication with the sensor 113.

[0033] In some embodiments depicted by FIG. 1 , the intravascular device 102 includes a locking section 118 and a knob or retaining section 120. To form the locking section 118, a machining process is used to remove the polymer layer 250 and the conductive ribbon 260 at the locking section 118 and to shape the proximal core 220 into a desired shape at the locking section 118. As shown in FIG. 1 , the locking section 118 includes a reduced diameter and the knob or retaining portion has a diameter substantially similar to the diameter of the proximal core 220 at the connecting portion 114. In some examples, since the machining process removes the conductive ribbon at the locking section 118, the proximal end of the conductive ribbon 260 is exposed to moisture and / or liquids, such as blood, saline, disinfectant, and / or enzymatic cleaning solutions, and an insulating layer 158 is formed over the proximal end portion of the connecting portion 114 to insulate the exposed conductive ribbon 260.

[0034] In some aspects, a connector 314 provides electrical connectivity between the conductive portions 132, 134 and the patient interface monitor 304. The patient interface monitor (PIM) 304 may optionally connect to a console or processing system 306 that includes or communicates with a display 308.

[0035] The endoluminal sensing system 100 may be located in a catheterization lab having a control room. The processing system 306 may be located in the control room. Optionally, the processing system 306 may be located elsewhere, such as in the catheterization lab itself. A catheterization lab may include a sterile field, while its associated control room may or may not be sterile depending on the procedure to be performed and / or the medical facility. In some aspects, the intravascular device 102 may be controlled from a remote location, such as a control room, such that an operator need not be in close proximity to the patient.

[0036] The intravascular device 102, PIM 304, and display 308 may be communicatively coupled directly or indirectly to the processing system 306. These elements may be communicatively coupled to the processing system 306 via wired connections, such as conductive members 230, which are standard copper multifilar conductor bundles. The processing system 306 may be communicatively coupled to one or more data networks, for example, a TCP / IP-based local area network (LAN). In other aspects, a different protocol, such as Synchronous Optical Network (SONET), may be utilized. In some cases, the processing system 306 may be communicatively coupled to a wide area network (WAN).

[0037] The PIM 304 forwards the received signals to a processing system 306 where the information is processed and displayed on a display 308 (e.g., as physiological data in graphical, symbolic, or alphanumeric format). The console or processing system 306 may include a processor and memory. The processing system 306 may be operable to facilitate features of the endoluminal sensing system 100 described herein. For example, the processor may execute computer readable instructions stored on a non-transitory tangible computer readable medium.

[0038] The PIM 304 facilitates communication of signals between the processing system 306 and the intravascular device 102. The PIM 304 may be communicatively disposed between the processing system 306 and the intravascular device 102. In some aspects, the PIM 304 performs pre-processing of the data before relaying the data to the processing system 306. In an example of such an aspect, 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 to support operation of the intravascular device 102 via the conductive members 230.

[0039] A multi-filar cable or transmission line bundle, such as the conductive member 230, may include multiple conductors, including one, two, three, four, five, six, seven, or more conductors. In the example shown in FIG. 2, 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 elongate member 106, and a helical section 234, where the conductive member 230 is wrapped around the exterior of the flexible elongate member 106 and then overcoated with an insulating polymer / plastic 240. Communication along the conductive member 230, if any, may be via a number of methods or protocols, including serial, parallel, and others, with one or more fillers of the conductive member 230 carrying signals. One or more fillers of the conductive member 230 may carry direct current (DC) power, alternating current (AC) power, or may function as a ground connection.

[0040] The display or monitor 308 may be a display device such as a computer monitor or other type of screen. The display or monitor 308 may be used to display selectable prompts, instructions, and visualization of imaging data to the user. In some aspects, the display 308 may be used to provide a procedure-specific workflow to the user for completing an endoluminal imaging procedure.

[0041] Before proceeding, 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.

[0042] 3A-3H are schematic cross-sectional top views of an intravascular device 102 according to an embodiment of the present disclosure. In FIG. 3A, the proximal core 220 and the distal core 210 are visible. In some examples, the proximal core 220 and the distal core 210 may be a single core wire. In some examples, the proximal core 220 and the distal core 210 are separate core wires. In some embodiments, 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 elongate member 106. In some examples, the distal core 210 and the proximal core 220 are electrically conductive. In some examples, the distal core 210 is electrically and mechanically coupled to the proximal core 220. That is, in some examples, at a location along the length of the flexible elongate member 106, the distal portion of the proximal core 220 is coupled to the proximal portion of the distal core 210. In some examples, the location may be multiple locations along the length of the flexible elongate member 106. In some examples, one of the multiple locations may be a junction between the distal core 210 and the proximal core 220, electrically and mechanically coupling the distal core 210 to the proximal core 220 and surrounded and contained by the hypotube 215, which is a tubular member. In some examples, the diameters of the distal core 210 and the proximal core 220 may vary along their lengths. The sensor mount / housing 320 is coupled to the distal core 210 a length from the distal end of the distal core 210 (see, e.g., FIGS. 4 and 5).

[0043] In the embodiment of FIG. 3B, a first polymer coating 322 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210 surrounding the proximal core 220 and the distal core 210 (see, e.g., FIG. 6). In this regard, the first polymer layer 322 is disposed over, e.g., directly contacting and / or partially / completely surrounding in cross section, the proximal core 220 and the distal core 210. The first polymer coating 322 may be an insulating material disposed between the core wire and one or more conductive layers 324. In the embodiment of FIG. 3C, the one or more conductive layers 324 may then be applied along the length of the intravascular device 102 on top of the first polymer coating 322 from the proximal end of the proximal core 220 to the distal end of the distal core 210 (see, e.g., FIGS. 10, 11, and 12). In some embodiments, the one or more conductive layers 324 may be, for example, electrical traces, conductive inks, metal deposition, electroplating, three-dimensional printed conductive polymers or metals, extruded conductive materials, etc. In some embodiments, the one or more conductive layers 324 are disposed on the hypotube 215 that joins the proximal core 220 to the distal core 210, such that the one or more conductive layers 324 are disposed on the outside of the hypotube 215, i.e., the tubular member. In some embodiments, the one or more conductive layers 324 are different from the proximal core 220 and the distal core 210. For example, the proximal core 220 and the distal core 210 provide structure for the intravascular device 102. The proximal core 220 and the distal core 210 provide different mechanical properties for the intravascular device 102. The one or more conductive layers 324 provide electrical communication. In some embodiments, the proximal core 220 and the distal core 210 also provide electrical communication with the two core wires, and the electrical pathways of the proximal core 220 and the distal core 210 are not continuous between the sensor and the conductive portion due to the interconnection between the proximal core 220 and the distal core 210. The one or more conductive layers 324 are of continuous length, uninterrupted, and without electrical interconnection, and thus each (e.g., each single) conductive member extends continuously and uninterrupted. In some instances, the one or more conductor layers 324 may include one, two, three, four, five, six, seven, or more conductor layers.In some aspects, the one or more conductive layers 324 are formed parallel to the longitudinal axis 326. In some aspects, the one or more conductive layers 324 are uniformly separated from one another. In some aspects, the one or more conductive layers 324 are separated from one another by a predetermined space. For example, in some example embodiments, 5 μm conductive layers 324 are separated by a 5 μm space. In some aspects, the one or more conductive layers 324 are a uniform distance away from the sensor mount / housing 320.

[0044] In the embodiment of Figure 3D, the second polymer coating 328 is applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding exposed portions of the proximal and distal cores 220 and 210 where the one or more conductive layers 324 are not formed and portions where the one or more conductive layers 324 are formed (see, e.g., Figure 13). Thus, in cross section, the periphery of the one or more conductive layers 324 is completely surrounded by at least one of the first polymer coating 322 or the second polymer coating 328. In the embodiment of Figure 3E, a portion 330 of the first polymer coating 322, the one or more conductive layers 324, and / or the second polymer coating 328 on the distal end of the distal core 210 is ablated and / or grounded to receive a tip coil. In the embodiment of FIG. 3E, the first polymer coating 322, the one or more conductive layers 324, and / or a portion 332 of the second polymer coating 328 on the proximal end of the proximal core 220 are ablated and / or ground to form the locking section 118 and the knob or retention section 120. In the embodiment of FIG. 3F, the first polymer coating 322, the one or more conductive layers 324, and / or a portion 334 of the second polymer coating 328 are ablated and / or ground to expose a portion of the sensor mount / housing 320, i.e., an opening, window, etc., to form a sensor shape such that the sensor 112 may be coupled to the sensor mount / housing 320. (See, e.g., FIG. 7). In the embodiment of FIG. 3G, a tip coil 336 may be coupled to the intravascular device 102 at the distal end of the distal core 210. In the embodiment of FIG. 3G, the sensor 112 may be coupled to the sensor mount / housing 320 at portion 334 (see, e.g., FIGS. 8 and 9). In some examples, the sensor 112 may be a flow sensor or a pressure sensor. In some examples, the sensor 112 may be a piezoresistive sensor or a piezoelectric sensor. In the embodiment of FIG. 3H, a hydrophilic coating 340 is applied to the second polymer coating 328 and / or all or some portions of the sensor 112.In some embodiments, the hydrophilic coating 340 may not be applied to the sensor 112, i.e., the distal portion, and the hydrophilic coating 340 begins just proximal to the sensor 112. In some embodiments, the hydrophilic coating 340 may not be applied to the proximal connector, i.e., the proximal portion, and the hydrophilic coating 340 begins just distal to the conductive portion 132.

[0045] FIG. 4 is a schematic diagram of an intravascular device 102 according to an embodiment of the present disclosure. In FIG. 4, the proximal core 220 and the distal core 210 are visible. In some examples, the distal core 210 is electrically and mechanically coupled to the proximal core 220. That is, in some examples, a distal portion of the proximal core 220 is coupled to a proximal portion of the distal core 210 at a location along the length of the flexible elongate member 106. In some examples, the location may be multiple locations along the length of the flexible elongate member 106. In some examples, one of the multiple locations may be a junction between the distal core 210 and the proximal core 220, which electrically and mechanically couples the distal core 210 to the proximal core 220 and is surrounded and contained by a tubular member, hypotube 215. As shown, in some examples, the diameter of the distal core 210 may vary along its length. The sensor mount / housing 320 is coupled to the distal end of the distal core 210 and is shown in an expanded view in FIG. 5. FIG. 5 is a schematic diagram of a sensor mount / housing 320 coupled to the distal core 210 of an intravascular device 102 according to an embodiment of the present disclosure. In some embodiments, the sensor mount / housing 320 is coupled to the distal core 210 a length from the distal end of the distal core 210. In some examples, the sensor mount / housing 320 surrounds the entire diameter of the distal core 210. In some examples, the sensor mount / housing 320 surrounds only a portion of the diameter of the distal core 210, such as three-quarters of the diameter.

[0046] 6 is a schematic diagram of a first polymer coating 322 applied to an intravascular device 102 according to an embodiment of the present disclosure. In some embodiments, the first polymer coating 322 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210 to surround the proximal core 220 and the distal core 210. In this regard, the first polymer layer 322 may be disposed over, directly contacting, and / or partially / completely surrounding in cross section the proximal core 220 and the distal core 210, for example. In some examples, a portion 334 of the first polymer coating 322 is ablated and / or ground to form a sensor shape such that the sensor 112 may be coupled to the sensor mount / housing 320, shown in a close-up view in FIG. 7. The portion 334 may be movable and / or may be referred to as an opening or window. 7 is a schematic diagram of exposing a portion of the sensor mount / housing 320 of an intravascular device 102 according to an embodiment of the present disclosure. In some embodiments, a portion 334 of the first polymer coating 322 is ablated and / or ground to form a sensor shape such that the sensor 112 may be coupled to the sensor mount / housing 320.

[0047] FIG. 8 is a schematic diagram of mounting a sensor 112 to a sensor mount / housing 320 of an intravascular device 102 according to an embodiment of the present disclosure. In some cases, the sensor 112 may be coupled such that a distal end of the sensor 112 having an active sensing element 802 is disposed toward the distal end of the distal core 210 and a proximal end of the sensor 112 having electrical contact pads 804 and 806 for the sensor 112 is disposed toward the proximal end of the distal core 210. The active sensing element 802 may be movable and / or may be referred to as a diaphragm or membrane. The sensor 112 may be coupled to the sensor mount / housing 320 by, for example, soldering, ultrasonic welding, conductive adhesive, or the like. FIG. 9 is a schematic top view of a sensor 112 of an intravascular device 102 according to an embodiment of the present disclosure. In some examples, the sensor 112 includes an active sensing element 802 disposed toward a distal end of the sensor 112 and one or more electrical contact pads 804 and 806 at a proximal end of the sensor 112 .

[0048] 10 is a schematic diagram of applying one or more conductive layers 324 along the length of an intravascular device 102, according to aspects of the present disclosure. In some examples, one or more conductive layers 324 may then be applied along the length of the intravascular device 102 over the first polymer coating 322 from the proximal end of the proximal core 220 to the distal end of the distal core 210 (FIG. 4). In some examples, the one or more conductive layers 324 may wrap partially around a diameter of the distal core 210 such that a first end 1102 of the partial wrap of the one or more conductive layers 324 is coupled to the one or more conductive layers 324 applied along the length of the intravascular device 102, and a second end 1104 of the partial wrap is coupled to one of the one or more electrical contact pads 804 and 806 of the sensor 112, shown in a close-up view in FIG. Thus, in some examples, one or more conductive layers 324 include longitudinal segments that extend along the length and circumferential segments that extend circumferentially from the longitudinal segments to the sensor. In some examples, these segments may be considered to form a completely continuous / uninterrupted length since the segments are all conductive members, and therefore when the segments are applied, they become part of each other and therefore all form the same whole (e.g., no soldering, ultrasonic welding, conductive adhesive, or other third component establishes electrical communication between the segments). The material of the segments themselves establishes the electrical communication. In some aspects, the longitudinal segments themselves have no interconnections / interruptions.

[0049] In some embodiments, the one or more conductive layers 324 may be, for example, electrical traces, conductive inks, metal deposition, electroplating, three-dimensional printed conductive polymers or metals, extruded conductive materials, etc. In some embodiments, the one or more conductive layers 324 are disposed on the hypotube 215 that joins the proximal core 220 to the distal core 210, such that the one or more conductive layers 324 are disposed on the outside of the hypotube 215, i.e., the tubular member. In some embodiments, the one or more conductive layers 324 are different from the proximal core 220 and the distal core 210. For example, the proximal core 220 and the distal core 210 provide structure to the intravascular device 102. The proximal core 220 and the distal core 210 provide different mechanical properties to the intravascular device 102. The one or more conductive layers 324 provide electrical communication. In some aspects, the proximal core 220 and the distal core 210 also provide electrical communication with the two core wires, and the electrical pathways of the proximal core 220 and the distal core 210 are not continuous between the sensor 112 and the conductive portions 132, 134, 136 due to the interconnection between the proximal core 220 and the distal core 210. The conductive layer or layers 324 are of continuous length, uninterrupted and without electrical interconnections, and thus each individual single conductive member extends continuously and uninterrupted.

[0050] FIG. 11 is a schematic diagram of one or more conductive layers 324 coupled to one of one or more electrical contact pads 804 and 806 of a sensor 112 of an intravascular device 102 according to an embodiment of the present disclosure. In some examples, a first end 1102 of a partial wrap of one or more conductive layers 324 coupled to one or more conductive layers 324 is applied along the length of the intravascular device 102. In some examples, a second end 1104 of a partial wrap of one or more conductive layers 324 may be coupled to one of one or more electrical contact pads 804 and 806 of the sensor 112 by, for example, soldering, ultrasonic welding, conductive adhesive, etc. FIG. 12 illustrates a cross-sectional view of the intravascular device 102 of FIG. 11 according to an embodiment of the present disclosure as seen along the line of section AA taken therein. In the embodiment of FIG. 12, a sensor mount / housing 320 is coupled to a distal end of a distal core 210. A first polymer coating 322 may then be applied to the distal core 210 and the sensor mount / housing 320 to surround the distal core 210 and the sensor mount / housing 320 and fill any gaps between the distal core 210 and the sensor mount / housing 320. A portion 334 of the first polymer coating 322 is ablated and / or ground to form a sensor shape such that the sensor 112 may be coupled to the sensor mount / housing 320. One or more conductive layers 324 may then be applied to the intravascular device 102 over the first polymer coating 322. In some examples, the one or more conductive layers 324 wrap partially around a diameter of the distal core 210 such that a first end 1102 of the partial wrap of the one or more conductive layers 324 couples to the one or more conductive layers 324 applied along the length of the intravascular device 102 and a second end 1104 of the partial wrap couples to the electrical contact pad 804 of the sensor 112.

[0051] 13 is a schematic diagram of a second polymer coating 328 applied to an intravascular device 102 according to an embodiment of the present disclosure. In some embodiments, the second polymer coating 328 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the proximal core 220 and the distal core 210. Thus, in cross section, the periphery of the one or more conductive layers 324 is completely surrounded by at least one of the first polymer coating 322 or the second polymer coating 328. In some examples, the second polymer coating 328 may be applied such that the sensor 112 remains exposed, which is shown in an expanded view in FIG. 14. FIG. 14 is a schematic diagram of a second polymer coating 328 applied to the distal core 210 of an intravascular device 102 according to an embodiment of the present disclosure. 13, the second polymer coating 328 may be applied such that the sensor 112 remains exposed. In some examples, the hydrophilic coating 340 may be applied over all or a portion of the length of the second polymer coating 328. In some embodiments, the hydrophilic coating 340 may not be applied to the sensor 112, i.e., the distal portion, and the hydrophilic coating 340 begins just proximal to the sensor 112.

[0052] 15 is a schematic diagram of applying conductive portions 132, 134, 136 to an intravascular device 102 according to an embodiment of the present disclosure. In some embodiments, one or more conductive portions 132, 134, 136 are applied to a proximal end of the proximal core 220. In some embodiments, the conductive portions 132, 134, 136 may be conductive inks printed and / or deposited around the flexible elongate member 106. In some embodiments, the conductive portions 132, 134, 136 may be conductive metal rings disposed around the flexible elongate member. In some examples, the conductive portions 132, 134, 136 are formed directly on the second polymer coating 328. In some cases, each of the one or more conductive layers 324 is in direct communication with one of the conductive portions 132, 134, and / or 136, respectively. In some examples, the one or more conductive layers 324 are electrically and mechanically coupled to and in electrical communication with the sensor 112, for example, by soldering, ultrasonic welding, conductive adhesive, etc. In some examples, the hydrophilic coating 340 may be applied over all or a portion of the length of the second polymer coating 328. In some aspects, the hydrophilic coating 340 may not be applied to the proximal connector, i.e., the proximal portion, and the hydrophilic coating 340 begins just distal to the conductive portion 132. In some examples, the hydrophilic coating 340 may be provided between the second polymer coating 328 and the conductive portions 132, 134, and 136. In this regard, ablation passes through the hydrophilic coating 340 and the second polymer coating 328 to establish electrical communication between each of the conductive portions 132, 134, and 136 and each of the conductive members 324.

[0053] 16 shows a cross-sectional view of the intravascular device 102 of FIG. 15 as viewed along line of section BB taken therein, according to an embodiment of the present disclosure. In the embodiment of FIG. 16, a first polymer coating 322 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the proximal and distal cores 220 and 210. In some embodiments, one or more conductive layers 324 may then be applied along the length of the intravascular device 102 over the first polymer coating 322 from the proximal end of the proximal core 220 to the distal end of the distal core 210. In some embodiments, a second polymer coating 328 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the proximal and distal cores 220 and 210. Prior to applying the conductive portion 132 to the proximal end of the proximal core 220, the portion 1602 of the second polymer coating 328 may be ablated to expose the conductive layer 324. The conductive portion 132 may then be applied to the proximal end of the proximal core 220 such that the conductive portion 132 is electrically and mechanically coupled to and in electrical communication with the conductive layer 324, for example, by soldering, ultrasonic welding, a conductive adhesive, or the like.

[0054] 17 illustrates a cross-sectional view of the intravascular device 102 of FIG. 15 taken along line CC, according to an embodiment of the present disclosure. In the embodiment of FIG. 17, a first polymer coating 322 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the proximal and distal cores 220 and 210. In some embodiments, one or more conductive layers 324 may then be applied along the length of the intravascular device 102 over the first polymer coating 322 from the proximal end of the proximal core 220 to the distal end of the distal core 210. In some embodiments, a second polymer coating 328 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the one or more conductive layers 324 and the first polymer coating 322.

[0055] FIG. 18 illustrates a cross-sectional view of the intravascular device 102 of FIG. 11 as viewed along the line of section AA taken therein, according to an embodiment of the present disclosure. FIG. 18 includes similar features as described in FIG. 12. In addition to the elements shown in FIG. 12, FIG. 18 further illustrates a second polymer coating 328 that may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the proximal core 220 and the distal core 210. In some examples, a hydrophilic coating 340 may be applied over all or a portion of the length of the second polymer coating 328. In some embodiments, the hydrophilic coating 340 may not be applied to the sensor 112, i.e., the distal portion, and the hydrophilic coating 340 begins just proximal to the sensor 112.

[0056] 19 illustrates a cross-sectional view of an intravascular device 102 according to an embodiment of the present disclosure. In the embodiment of FIG. 19, a sensor mount / housing 320 is coupled to a distal end of a distal core 210. A first polymer coating 322 may then be applied to the distal core 210 and the sensor mount / housing 320 to surround the distal core 210 and the sensor mount / housing 320 and fill any gaps between the distal core 210 and the sensor mount / housing 320. One or more portions 334 of the first polymer coating 322 are ablated and / or ground to form a sensor shape such that a sensor 112 may be coupled to the sensor mount / housing 320. One or more conductive layers 324 may then be applied to the intravascular device 102 over the first polymer coating 322. In some examples, the one or more conductive layers 324 wrap partially around the diameter of the distal core 210 such that a first end 1102 of the partial wrap of the one or more conductive layers 324 couples to the one or more conductive layers 324 applied along the length of the intravascular device 102 and a second end 1104 of the partial wrap couples to electrical contact pads 804 or 806 of the sensor 112, respectively. In some examples, the sensor 112 may include a conductive bottom 1902 that may be mechanically and electrically coupled to the sensor mount / housing 320. In some examples, all or a portion of the sensor mount housing 320 may be conductive to couple to conductive material within the body of the sensor 112, thereby providing a conductive path. In such examples, an electrical path is provided between the sensor 112 and the conductive portions 132, 134, or 136, i.e., from the sensor 112 to the sensor mount / housing 320, the distal core 210, the proximal core 220, the conductive portions 132, 134, or 136 (and vice versa). In some examples, the sensor 112 may include a conductive bottom portion 1902 that may be mechanically and electrically coupled to the distal core 210. For example, a portion of the sensor mount / housing 320 may be omitted between the conductive bottom portion 1902 and the distal core 210, such that the conductive bottom portion 1902 directly contacts the distal core 210, such that the sensor 112 is mechanically and electrically coupled directly to the distal core 210.In such examples, an electrical path is provided between the sensor 112 and the conductive portions 132, 134, or 136, i.e., from the sensor 112 to the distal core 210, the proximal core 220, to the conductive portions 132, 134, or 136 (or vice versa). In such cases, the sensor mount / housing 320 may be non-conductive.

[0057] 20 shows a cross-sectional view of an intravascular device 102 according to an embodiment of the present disclosure. In the embodiment of FIG. 17, a first polymer coating 322 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the proximal and distal cores 220 and 210. In some embodiments, a first conductive layer 324a may then be applied along the length of the intravascular device 102 over the first polymer coating 322 from the proximal end of the proximal core 220 to the distal end of the distal core 210. In some embodiments, a second polymer coating 323 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210, surrounding the first conductive layer 324a. In some aspects, a second conductive layer 324b may then be applied along the length of the intravascular device 102 over the second polymer coating 323 from the proximal end of the proximal core 220 to the distal end of the distal core 210. In some cases, the shape of the first conductive layer 324a and the second conductive layer 324b may be fully circular or partially circular. In some examples, the second polymer coating 323 between the first conductive layer 324a and the second conductive layer 324b provides electrical insulation between the two conductive layers. In some aspects, a third polymer coating 328 may be applied along the length of the intravascular device 102 from the proximal end of the proximal core 220 to the distal end of the distal core 210 and surround the second conductive layer 324b. In some examples, the first conductive layer 324a and the second conductive layer 324b provide two electrical paths between the sensor 112 and two of the conductive portions 132, 134, or 136. In such cases, the distal core 210 and the proximal core 220, which may be electrically and mechanically coupled to one another, provide a third electrical path between the sensor 112 and a third of the conductive portions 132, 134, or 136.

[0058] It may thus be seen that the electrical trace assembly advantageously allows for the use of conductive materials that may be applied in thinner layers, reducing the dimensions (thickness) of the electrical connection, facilitating centering of the distal core within the wire body, and eliminating surface irregularities. The sensor is electrically connected using a bonding process and additional bonding material. The ink (3D) traces can be directly connected to the sensor or sensor mount, and do not require an additional bonding process that requires additional force on the sensor. The straightness and torque response of the endoluminal device may also be improved, as ribbons and / or multi-filar conductor bundles are reduced or eliminated, adding stiffness and local torque to the guidewire or catheter. Many variations are possible to the examples and embodiments described above.

[0059] The logical operations making up aspects of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Moreover, it should be understood that they may be arranged or performed in any order unless expressly claimed or a particular order is inherently necessitated by the language of the claims. Moreover, it should be understood that the described technology may be used in single-use and multi-use electrical and electronic devices for medical or non-medical uses.

[0060] All orientation references, e.g., top, bottom, 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 aid the reader's understanding of the claimed subject matter and do not create limitations, particularly with respect to the location, orientation, or use of the metallic ink conductor assembly. Connection references, e.g., attached, coupled, connected, joined, should be interpreted broadly and may include intermediate members between a collection of elements and relative movement between the elements, unless otherwise specified. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. The term "or" should be interpreted to mean "and / or" and not "exclusive or". The term "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude a plurality. Unless otherwise stated in the claims, the values ​​recited are to be interpreted only as examples and not as limiting.

[0061] The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the metallic ink conductor assembly as defined in the claims. Although various 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, one skilled in the art could make numerous modifications to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter.

[0062] Further embodiments are contemplated. All subject matter contained in the above description and shown in the accompanying drawings is intended to be interpreted only as illustrative of particular embodiments and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter defined in the following claims.

Claims

1. a flexible elongate member configured to be placed within a patient's blood vessel, the flexible elongate member having a proximal portion and a distal portion, the proximal portion having a proximal corewire and the distal portion having a distal corewire; a sensor disposed on the distal portion of the flexible elongate member, the sensor configured to acquire medical data related to the blood vessel while the flexible elongate member is disposed within the blood vessel; and a connector disposed on the proximal portion of the flexible elongate member; a conductive member for establishing electrical communication between the sensor and the connector, the conductive member being continuous between the sensor and the connector; 1. An intravascular guidewire having An apparatus having the above configuration.

2. The device of claim 1 , wherein a distal portion of the conductive member is directly coupled to the sensor.

3. The connector has a conductive band; a proximal portion of the conductive member is directly coupled to the conductive band; 2. The apparatus of claim 1.

4. 2. The device of claim 1, wherein the intravascular guidewire has a plurality of conductive members that establish electrical communication between the sensor and the connector, and each conductive member of the plurality of conductive members is continuous between the sensor and the connector.

5. a distal portion of the proximal core wire is coupled to a proximal portion of the distal core wire at a location along the length of the flexible elongate member; the conductive member is continuous across the location; 2. The apparatus of claim 1.

6. the location includes a tubular member; the distal portion of the proximal core wire and the proximal portion of the distal core wire are disposed inside the tubular member; The conductive member is disposed on the outside of the tubular member.

6. The apparatus of claim 5.

7. the flexible elongate member further comprising a first polymer layer disposed over the proximal and distal core wires; the first polymer layer is configured to provide insulation of the conductive member from the proximal core wire and the distal core; 2. The apparatus of claim 1.

8. the intravascular guidewire further comprising a sensor mount; the sensor is coupled to the sensor mount; the first polymer layer is disposed over the sensor mount; 8. The apparatus of claim 7.

9. The apparatus of claim 8 , wherein the first polymer layer has an opening exposing the sensor.

10. The device of claim 7 , wherein the flexible elongate member further comprises a second polymer layer disposed over the conductive member.

11. The device of claim 10 , wherein the flexible elongate member further comprises a hydrophilic coating disposed on the second polymer layer.

12. The device of claim 10 , wherein in cross section, the conductive member is completely surrounded by at least one of the first polymer layer or the second polymer layer.

13. The apparatus of claim 1 , wherein the conductive members comprise electrical traces.

14. 12. The apparatus of claim 11, wherein the electrical traces comprise at least one of a conductive ink, a metal deposition, electroplating, a three-dimensional printed conductive polymer or metal, or an extruded conductive material.

15. The apparatus of claim 1 , wherein the sensor comprises at least one of a pressure sensor or a flow sensor.

16. a flexible elongate member configured to be placed within a patient's blood vessel, the flexible elongate member having a proximal portion and a distal portion, the proximal portion having a proximal corewire, the distal portion having a distal corewire, the proximal corewire being coupled to the distal corewire at a location along the length of the flexible elongate member; at least one pressure or flow sensor disposed on a distal portion of the flexible elongate member, the at least one pressure or flow sensor configured to acquire at least one pressure or flow data, respectively, associated with a blood vessel while the flexible elongate member is disposed within the blood vessel; and a connector disposed on a proximal portion of the flexible elongate member; a conductive member for establishing electrical communication between the sensor and the connector, the conductive member being continuous between the sensor and the connector, including across the location; 1. An intravascular guidewire having An apparatus having the above configuration.

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