Patent Description:
The word "filar" is a noun referring to a thin thread, line, or filament. Fine electrical wires may be referred to as filars. Small-diameter medical devices such as intraluminal (e.g., intravascular) catheters and guidewires may incorporate sensors (e.g., pressure, temperature, flow, or imaging sensors) whose power and communications occur through multi-filar (e.g., bifilar, trifilar, etc.) electrical conductor bundles. Decreases in device size drive challenges in the device manufacturing process related to routing, wrapping, and securing of multi-filar electrical conductor bundles.

Current medical devices such as guidewires and catheters use a bundle of electrical filars, usually joined as two, three, or more conductive filars, to make electrical connections between electrical components, e.g. sensors or transducers and contacts. In order to make these connections, the filars may be wrapped or pulled along the length of the device, from one end of the device to the other end. Because pure copper and many copper alloys have a very low tensile and yield strength, the mechanical strength of conventional filars is low. The manufacturing process for an intraluminal catheter or guidewire device may involve wrapping or stretching of the multi-filar conductor bundle, which requires tensioning. Unfortunately, if this tensioning exceeds a threshold longitudinal force, it can cause the conductive filars to plasticly deform, which can result in undesirable elongation and/or necking, e.g., up to <NUM>% elongation in some current processes. The associated narrowing of the conductor affects both the mechanical performance and the electrical performance of the filar, which can lead to manufacturing defects.

The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound.

Disclosed are intraluminal devices that include reinforced multi-filar conductor bundles having improved mechanical characteristics and properties. For example, improved tensile strength may reduce elongation and necking of fine-gauge filars during the manufacturing process for medical devices, thus reducing manufacturing defects. The inclusion of a reinforcing filar can reduce or eliminate plastic deformation of the multi-filar conductor bundle, while maintaining the required electrical properties.

In some presently used devices, alternate copper alloys with higher strength (e.g. beryllium copper, abbreviated as BeCu) are sometimes employed in place of pure copper in the filars of a multi-filar conductor bundle. However, these materials may have only about <NUM>-<NUM>% of the electrical conductivity of pure copper, which may decrease the maximum current the filars can carry. The present disclosure therefore addresses this issue by retaining pure copper, high-conductivity copper alloys, or other high-conductivity materials for a majority of the filars in a multi-filar conductor bundle, but adds (or replaces one of the low-strength conducting filars with) a reinforcing filar made of a high-strength material such as stainless steel. The reinforcing filar may or may not have an insulative coating, and may or may not be a different gauge than the other filars in the bundle. Any manufacturing or assembly process that involves tensioning of the multi-filar bundle may benefit from the reinforced multi-filar conductor bundle of the present disclosure. Depending on the implementation, the reinforcing filar may be used in the electrical circuit as a conductor, or may run alongside the other electrical filars but not be electrically connected.

The reinforced multi-filar conductor bundle disclosed herein has particular, but not exclusive, utility for intraluminal medical catheters and guidewires. One general aspect of the reinforced multi-filar conductor bundle includes an intraluminal sensing guidewire. The intraluminal sensing guidewire includes a flexible elongate member configured to be positioned within a body lumen of the patient, where the flexible elongate member includes a metallic core wire extending along a longitudinal axis; a sensing element disposed at a distal portion of the flexible elongate member and configured to obtain physiological data while positioned within the body lumen, and an electrical connector disposed at a proximal portion of the flexible elongate member. The intraluminal sensing guidewire also includes a filar bundle disposed between the sensing element and the electrical connector, the filar bundle including: a first conductive filar including a first material strength, where the first conductive filar is in electrical communication with sensing element and the electrical connector; and a first reinforcement filar including a second material strength greater than the first material strength.

Implementations may include one or more of the following features. In some embodiments, the first conductive filar and the first reinforcement filar extend alongside one another in a helical manner around the metallic core wire. In some embodiments, the filar bundle further includes a second conductive filar including the first material strength, where the second conductive filar is in electrical communication with sensing element and the electrical connector. In some embodiments, the filar bundle further includes a second reinforcement filar including the second material strength. In some embodiments, the first reinforcement filar includes an insulative coating. In some embodiments, the first conductive filar includes an insulative coating. In some embodiments, the filar bundle further includes an outer coating that mechanically couples the first conductive filar to the first reinforcement filar along at least a portion of a length of the first conductive filar and the first reinforcement filar. In some embodiments, the first conductive filar includes copper. In some embodiments, the first reinforcement filar includes stainless steel. In some embodiments, the first reinforcement filar includes a cross-sectional diameter larger than a cross-sectional diameter of the first conductive filar. In some embodiments, the length of the first reinforcement filar is less than the length of the first conductive filar. In some embodiments, the filar bundle includes a helical section and a non-helical section, where, in the non-helical section, at least the first conductive filar extends longitudinally along a length of the flexible elongate member toward at least one electrical contact, where the first conductive filar is electrically connected to a conductive ribbon embedded within the flexible elongate member via the electrical contact.

One general aspect includes a method for assembling an intraluminal sensing guidewire. The method includes providing a flexible elongate member configured to be positioned within a body lumen of a patient, where the flexible elongate member includes a metallic core wire extending along a longitudinal axis; attaching a sensing element at a distal portion of the flexible elongate member, where the sensing element is configured to obtain the physiological data while positioned within the body lumen; attaching an electrical connector at a proximal portion of the flexible elongate member; assembling a filar bundle, where assembling a filar bundle includes coupling a conductive filar to a reinforcement filar, where the conductive filar includes a first material strength, and where the reinforcement filar includes a second material strength greater than the first material strength. The method also includes wrapping the filar bundle in a helical manner around the metallic core wire. The method also includes coupling at least the conductive filar of the filar bundle to the sensing element and the electrical connector.

Implementations may include one or more of the following features. In some embodiments, the conductive filar includes copper surrounded by an insulative coating. In some embodiments, the reinforcement filar includes stainless steel. In some embodiments, the reinforcement filar includes a cross-sectional diameter that is larger than a cross-sectional diameter of the conductive filar. In some embodiments, the reinforcement filar is shorter than the conductive filars. In some embodiments, assembling the filar bundle includes attaching the conductive filar to the reinforcement filar. Attaching the conductive filar to the reinforcement filar includes attaching an insulating coating of the conductive filar to an insulating coating of the conductive filar. In some embodiments, attaching the conductive filar to the reinforcement filar includes forming an insulating layer around the conductive filar and the reinforcement filar. In some embodiments, wrapping the filar bundle in the helical manner around the metallic core wire includes wrapping the filar bundle in the helical manner around a first section of the metallic core wire, and where the method further includes coupling the filar bundle to the flexible elongate member such that the filar bundle extends along a different second section of the metallic core wire in a linear manner.

One general aspect includes an intravascular flow-sensing guidewire. The intravascular flow-sensing guidewire also includes a flexible elongate member configured to be positioned within a blood vessel, where the flexible elongate member includes a metallic core wire extending along a longitudinal axis; a flow sensor disposed at a distal portion of the flexible elongate member and configured to sense a velocity of blood flow within the blood vessel, an electrical connector disposed at a proximal portion of the flexible elongate member. The intravascular flow-sensing guidewire also includes a filar bundle disposed between the flow sensor and the electrical connector, the filar bundle including: a first conductive filar including a first material having a first material strength; a second conductive filar including the first material, where the first conductive filar and the second conductive filar are in electrical communication with the flow sensor and the electrical connector; and a reinforcement filar including a different, second material of a second material strength greater than the first material strength, where the first conductive filar, the second conductive filar, and the reinforcement filar extend alongside one another in a helical manner around at least a portion of a length of the metallic core wire.

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 reinforced multi-filar conductor bundle, as defined in the claims, is provided in the following written description of various embodiments of the disclosure and illustrated in the accompanying drawings.

The reinforced multi-filar conductor bundle of the present disclosure provides an improved overall material strength of a filar assembly, to reduce elongation and necking of fine-gauge filars during the manufacturing process for medical devices. The fine gauge wires may, for example, have a size of <NUM>-<NUM> American Wire Gauge (AWG) or a diameter of <NUM> - <NUM> millimeters. Improving the tensile strength of the multi-filar conductor bundle can reduce manufacturing defects in small electronic devices, such as intravascular medical catheter and guidewire devices.

The introduction of a reinforcing filar can reduce or eliminate plastic deformation of the multi-filar conductor bundle, while maintaining electrical properties and performance. This may be accomplished by including one or more higher-strength materials into one or more of the fine gauge multi-filar electrical conductor bundles to optimize their processing and assembly into electro-mechanical devices. Often these electrical conductors are incorporated into medical devices for their electrical properties only, and do not require high mechanical strength. However, in the exemplary case of medical guidewires and catheters, there are manufacturing and assembly processes that could benefit from using electrical conductor bundles (e.g., cables) with higher mechanical strength.

Aspects of the present disclosure can include one or more features described in <CIT>,<CIT>, <CIT>, <CIT>, <CIT>, and <CIT>, and <CIT>.

The present disclosure therefore provides multi-filar conductor bundles that include pure copper or high-conductivity copper alloys for a majority of the filars in the bundle, and either (a) one or more non-conducting reinforcing filar with high tensile and high yield strength to the electrical conductor bundle without changing the number of conductive filars, (b) a conductive filar made of a high-strength material such as stainless steel, or (c) increasing the diameter of one of the filars, with or without changing its composition. Any of these approaches will increase the overall strength of the multi-filar bundle, while maintaining desirable electrical properties for at least a majority of the conductors. The reinforcing filar may or may not have an insulative coating and may or may not have a different diameter than the other filars in the bundle. For example, high-strength stainless steel may have a substantially lower electrical conductivity (e.g., <NUM>-<NUM>% of the conductivity of pure copper). Including one or more lower-conductivity filars along with relatively higher-conductivity filars may be suitable for use if not all filars carry large currents or high-frequency signals (e.g., a signal ground).

The fabrication of the multi-filar conductor bundle may be performed by a supplier, based on a component specification or material specification. The reinforced multi-filar conductor bundle may advantageously improve assembly workflows of intraluminal medical devices. Depending on the implementation, the reinforcing filar may be used in the electrical circuit as a signal-carrying conductor, as a ground conductor, or as a structural reinforcement that runs alongside the other electrical filars up to the point of termination and then not used in the electrical connections.

These descriptions are provided for exemplary purposes only, and should not be considered to limit the scope of the reinforced multi-filar conductor bundle. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

Additionally, while the description below may refer to blood vessels, it will be understood that the present disclosure is not limited to such applications. For example, the devices, systems, and methods described herein may be used in any body chamber or body lumen, including an esophagus, veins, arteries, intestines, ventricles, atria, or any other body lumen and/or chamber.

<FIG> is a diagrammatic side view of an intravascular sensing system <NUM> that includes an intravascular device <NUM> comprising a multi-filar electrical conductor bundle <NUM>, according to aspects of the present disclosure. The intravascular device <NUM> can be an intravascular guidewire sized and shaped for positioning within a vessel of a patient. The intravascular device <NUM> can include a distal tip <NUM> and a sensing component <NUM>. The sensing component <NUM> can be an electronic, electromechanical, mechanical, optical, and/or other suitable type of sensor. For example, the electronic component <NUM> can be a flow sensor configured to measure the velocity of blood flow within a blood vessel of a patient, a pressure sensor configured to measure a pressure of blood flowing within the vessel, or another type of sensor including but not limited to a temperature or imaging sensor. For example, flow data obtained by a flow sensor can be used to calculate physiological variables such as coronary flow reserve (CFR). Pressure data obtained by a pressure sensor may for example be used to calculate a physiological pressure ratio (e.g., FFR, iFR, Pd/Pa, or any other suitable pressure ratio). An 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 can include one or more ultrasound transducer elements, including an array of ultrasound transducer elements.

The intravascular device <NUM> includes a flexible elongate member <NUM>. The electronic component <NUM> is disposed at the distal portion <NUM> of the flexible elongate member <NUM>. The electronic component <NUM> can be mounted at the distal portion <NUM> within a housing <NUM> in some embodiments. A flexible tip coil <NUM> extends distally from the housing <NUM> at the distal portion <NUM> of the flexible elongate member <NUM>. A connection portion <NUM> located at a proximal end of the flexible elongate member <NUM> includes conductive portions <NUM>, <NUM>. In some embodiments, the conductive portions <NUM>, <NUM> can be conductive ink that is printed and/or deposited around the connection portion <NUM> of the flexible elongate member <NUM>. In some embodiments, the conductive portions <NUM>, <NUM> are conductive, metallic rings that are positioned around the flexible elongate member. A locking section is formed by collar <NUM> and knob <NUM> are disposed at the proximal portion <NUM> of the flexible elongate member <NUM>.

The intravascular device <NUM> in <FIG> includes a distal core wire <NUM> and a proximal core wire <NUM>. The distal core <NUM> and the proximal core <NUM> are metallic components forming part of the body of the intravascular device <NUM>. For example, the distal core <NUM> and the proximal core <NUM> are flexible metallic rods that provide structure for the flexible elongate member <NUM>. The diameter of the distal core <NUM> and the proximal core <NUM> can vary along its length. A joint between the distal core <NUM> and proximal core <NUM> is surrounded and contained by a hypotube <NUM>.

In some embodiments, the intravascular device <NUM> comprises a distal assembly and a proximal assembly that are electrically and mechanically joined together, which provides for electrical communication between the electronic component <NUM> and the conductive portions <NUM>, <NUM>. For example, flow data obtained by the electronic component <NUM> (in this example, electronic component <NUM> is a flow sensor) can be transmitted to the conductive portions <NUM>, <NUM>. Control signals (e.g., operating voltage, start/stop commands, etc.) from a processor system <NUM> in communication with the intravascular device <NUM> can be transmitted to the electronic component <NUM> via a connector <NUM> that is attached to the conductive portions <NUM>, <NUM>. The distal subassembly can include the distal core <NUM>. The distal subassembly can also include the electronic component <NUM>, the multi-filar conductor bundle <NUM>, and/or one or more layers of insulative polymer/plastic <NUM> surrounding the conductive members <NUM> and the core <NUM>. For example, the polymer/plastic layer(s) can insulate and protect the conductive members of the multi-filar cable or conductor bundle <NUM>. The proximal subassembly can include the proximal core <NUM>. The proximal subassembly can also include one or more layers of polymer layer(s) <NUM> (hereinafter polymer layer <NUM>) surrounding the proximal core <NUM> and/or conductive ribbons <NUM> embedded within the one or more insulative and/or protective polymer layer(s) <NUM>. In some embodiments, the proximal subassembly and the distal subassembly can be separately manufactured. During the assembly process for the intravascular device <NUM>, the proximal subassembly and the distal subassembly can be electrically and mechanically joined together. As used herein, flexible elongate member can refer to one or more components along the entire length of the intravascular device <NUM>, one or more components of the proximal subassembly (e.g., including the proximal core <NUM>, etc.), and/or one or more components the distal subassembly <NUM> (e.g., including the distal core <NUM>, etc.). The joint between the proximal core <NUM> and distal core <NUM> is surrounded by the hypotube <NUM>.

In various embodiments, the intravascular device <NUM> can 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 elongate member <NUM>. In such embodiments, a locking section <NUM> and a section <NUM> can be integrally formed at the proximal portion of the single core wire. The electronic component <NUM> can be secured at the distal portion of the single core wire. In other embodiments, such as the embodiment illustrated in <FIG>, the locking section <NUM> and the section <NUM> can be integrally formed at the proximal portion of the proximal core <NUM>. The electronic component <NUM> can be secured at the distal portion of the distal core <NUM>. The intravascular device <NUM> includes one or more conductive members in a multi-filar conductor bundle <NUM> in communication with the electronic component <NUM>. For example, the conductor bundle <NUM> can include one or more electrical wires that are directly in communication with the electronic component <NUM>. In some instances, the conductive members <NUM> are electrically and mechanically coupled to the electronic component <NUM> by, e.g., soldering. In some instances, the conductor bundle <NUM> comprises two or three electrical wires (e.g., a bifilar cable or a trifilar cable). An individual electrical wire can include a bare metallic conductor, or a metallic conductor surrounded by one or more insulating layers. The multi-filar conductor bundle <NUM> can extend along a length of the distal core <NUM>. For example, at least a portion of the conductive members <NUM> can be helically, or spirally, wrapped around an entire length of the distal core <NUM>, or a portion of the length of the distal core <NUM>.

The intravascular device <NUM> includes one or more conductive ribbons <NUM> at the proximal portion of the flexible elongate member <NUM>. The conductive ribbons <NUM> are embedded within polymer layer(s) <NUM>. The conductive ribbons <NUM> are directly in communication with the conductive portions <NUM> and/or <NUM>. In some instances, the multi-filar conductor bundle <NUM> is electrically and mechanically coupled to the electronic component <NUM> by, e.g., soldering. In some instances, the conductive portions <NUM> and/or <NUM> comprise conductive ink (e.g., metallic nano-ink, such as silver or gold nano-ink) that is deposited or printed directed over the conductive ribbons <NUM>.

As described herein, electrical communication between the conductive members <NUM> and the conductive ribbons <NUM> can be established at the connection portion <NUM> of the flexible elongate member <NUM>. By establishing electrical communication between the conductor bundle <NUM> and the conductive ribbons <NUM>, the conductive portions <NUM>, <NUM> can be in electrically communication with the electronic component <NUM>.

In some embodiments represented by <FIG>, intravascular device <NUM> includes a locking section <NUM> and a section <NUM>. To form locking section <NUM>, a machining process is necessary to remove polymer layer <NUM> and conductive ribbons <NUM> in locking section <NUM> and to shape proximal core <NUM> in locking section <NUM> to the desired shape. As shown in <FIG>, locking section <NUM> includes a reduced diameter while section <NUM> has a diameter substantially similar to that of proximal core <NUM> in the connection portion <NUM>. In some instances, because the machining process removes conductive ribbons in locking section <NUM>, proximal ends of the conductive ribbons <NUM> would be exposed to moisture and/or liquids, such as blood, saline solutions, disinfectants, and/or enzyme cleaner solutions, an insulation layer <NUM> is formed over the proximal end portion of the connection portion <NUM> to insulate the exposed conductive ribbons.

In some embodiments, a connector <NUM> provides electrical connectivity between the conductive portions <NUM>, <NUM> and a patient interface module or monitor <NUM>. The patient interface module (PIM) <NUM> may in some cases connect to a console or processing system <NUM>, which includes or is in communication with a display <NUM>. In some embodiments, the patient interface module <NUM> includes signal processing circuitry, such as an analog-to-digital converter (ADC), analog and/or digital filters, signal conditioning circuitry, and any other suitable signal processing circuitry for processing the signals provided by the electronic component <NUM> for use by the processing system <NUM>.

The system <NUM> may be deployed in a catheterization laboratory having a control room. The processing system <NUM> may be located in the control room. Optionally, the processing system <NUM> may be located elsewhere, such as in the catheterization laboratory itself. The catheterization laboratory 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 on the health care facility. In some embodiments, device <NUM> may be controlled from a remote location such as the control room, such than an operator is not required to be in close proximity to the patient.

The intraluminal device <NUM>, PIM <NUM>, and display <NUM> may be communicatively coupled directly or indirectly to the processing system <NUM>. These elements may be communicatively coupled to the medical processing system <NUM> via a wired connection such as a standard copper multi-filar conductor bundle <NUM>. The processing system <NUM> may be communicatively coupled to one or more data networks, e.g., a TCP/IP-based local area network (LAN). In other embodiments, different protocols may be utilized such as Synchronous Optical Networking (SONET). In some cases, the processing system <NUM> may be communicatively coupled to a wide area network (WAN).

The PIM <NUM> transfers the received signals to the processing system <NUM> where the information is processed and displayed on the display <NUM>. The console or processing system <NUM> can include a processor and a memory. The processing system <NUM> may be operable to facilitate the features of the intravascular sensing system <NUM> described herein. For example, the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.

The PIM <NUM> facilitates communication of signals between the processing system <NUM> and the intraluminal device <NUM>. In some embodiments, the PIM <NUM> performs preliminary processing of data prior to relaying the data to the processing system <NUM>. In examples of such embodiments, the PIM <NUM> performs amplification, filtering, and/or aggregating of the data. In an embodiment, the PIM <NUM> also supplies high- and low-voltage DC power to support operation of the intraluminal device <NUM> via the multi-filar conductor bundle <NUM>.

The multi-filar cable or transmission line bundle <NUM> can include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors. The multi-filar conductor bundle <NUM> can be positioned along the exterior of the distal core <NUM>. The multi-filar conductor bundle <NUM> and the distal core <NUM> can be overcoated with an insulative and/or protective polymer <NUM>. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> includes two straight portions <NUM> and <NUM>, where the multi-filar conductor bundle <NUM> extends linearly and parallel to a longitudinal axis of the flexible elongate member <NUM> on the exterior of the distal core <NUM>, and a helical or spiral portion <NUM>, where the multi-filar conductor bundle <NUM> is wrapped around the exterior of the distal core <NUM>. In some embodiments, the multi-filar conductor bundle <NUM> only includes a straight portion or only includes a helical or spiral portion. In general, the multi-filar conductor bundle <NUM> can extend in a linear, wrapped, non-linear, or non-wrapped manner, or any combination thererof. Communication, if any, along the multi-filar conductor bundle <NUM> may be through numerous methods or protocols, including serial, parallel, and otherwise, wherein one or more filars of the bundle <NUM> carry signals. One or more filars of the multi-filar conductor bundle <NUM> may also carry direct current (DC) power, alternating current (AC) power, or serve as an electrical ground connection.

The display or monitor <NUM> may 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 <NUM> may be used to display selectable prompts, instructions, and visualizations of imaging data to a user. In some embodiments, the monitor <NUM> may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure.

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

<FIG> is a side view of an example electronic component <NUM> of an intravascular device <NUM> in accordance with aspects of the present disclosure. For example, the electronic component <NUM> can be a pressure sensor, flow sensor, temperature sensor, or other sensor configured to measure a parameter of blood flow within a vessel of a patient. In an exemplary embodiment, the flow sensor is a single ultrasound transducer element. The transducer element emits ultrasound signals and receives ultrasound echoes reflected from anatomy (e.g., flowing fluid, such as blood). The transducer element generates electrical signals representative of the echoes. The signal-carrying filars carry this electrical signal from the sensor at the distal portion to the connector at the proximal portion. The processing system processes the electrical signals to extract the flow velocity of the fluid. In other embodiments, the device <NUM> may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord and peripheral nerves; the urinary tract; as well as valves within the blood, chambers or other parts of the heart, and/or other systems of the body. In addition to natural structures, the device <NUM> may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices. In some embodiments, the electronic component <NUM> may include an imaging component (e.g., an intravascular ultrasound imaging component), a measurement component (e.g., a pressure, flow, or temperature sensor) and/or a treatment component (e.g., an ablation component). In some embodiments the electronic component <NUM> may be fully or partially enclosed within a housing <NUM>. In some embodiments, the electronic component is located at or near the distal end of a flexible elongate member, and may include a distal tip <NUM> (e.g., an atraumatic tip). In some embodiments, one or more electronic components can be located at the distal portion of the flexible elongate member. For example, the one or more electronic components can be located at the distal tip (a leading edge of the flexible elongate member and/or where the distal portion terminates) or proximally spaced from the distal end (by, e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and/or other suitable values both larger and smaller). Some embodiments of the intraluminal device <NUM> include multiple, different electronic components (e.g., a pressure sensor and a flow sensor, or any other quantity or combination of sensors). In such embodiments, a first electronic component can be positioned at the distal tip of the flexible elongate member and the second electronic component can be spaced from the distal tip and/or from the first electronic component (by, e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and/or other suitable values both larger and smaller). In some embodiments, power, control signals, and electrical ground or signal return may be provided by the multi-filar conductor bundle <NUM>, which in the example of <FIG> is shown as a bifilar with two conductive filars <NUM> and <NUM>. The conductive filars <NUM> and <NUM> may for example be made of pure copper, or of a copper alloy such as BeCu or AgCu.

<FIG> is a perspective view of a multi-filar conductor bundle <NUM> in accordance with aspects of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a trifilar that includes three conductors <NUM>, <NUM>, and <NUM>, surrounded by insulating sheaths <NUM>, <NUM>, and <NUM>, respectively. The insulating sheaths may for example be made of polyimide. The additional overcoating <NUM> may for example be applied through dip coating, although other methods may be used instead or in addition. In a conventional trifilar, all three conductors may be of the same or similar diameter, and may be made of pure copper, or of a copper alloy such as BeCu. Although the multi-filar conductor bundle <NUM> is shown here with the conductors arranged side-by-side in a planar fashion, a person of ordinary skill in the art will appreciate that other arrangements may be employed instead or in addition.

In the illustrated embodiment, the second filar <NUM> comprises a different material than the first and third filars <NUM>, <NUM>. In this regard, the second filar <NUM> may comprise a material with a relatively higher strength than the filars <NUM>, <NUM>. For example, the second filar <NUM> may comprise stainless steel or a high-strength copper alloy, while the conductive filars <NUM>, <NUM> comprise other copper alloys or pure copper.

<FIG> is a cross-sectional view of a multi-filar conductor bundle <NUM> in accordance with at least one embodiment of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a trifilar that includes two conductive filars <NUM> and <NUM>, surrounded by insulating sheaths <NUM> and <NUM>, respectively. In the example shown in <FIG>, the center filar of the bundle <NUM> is a reinforcement filar <NUM>, which may for example be of a material (e.g., stainless steel) that has a higher tensile strength and/or higher yield strength than the conductive material (e.g., copper or BeCu) of the conductive filars <NUM> and <NUM>. The reinforcement filar <NUM> may include an insulating sheath <NUM>. In other embodiments, the reinforcement filar <NUM> does not include an insulating sheath <NUM>. The multi-filar conductor bundle <NUM> may or may not include an additional overcoating <NUM>, such as nylon or polyurethane, that joins the separate insulators <NUM>, <NUM>, and <NUM> together such that the filars <NUM>, <NUM>, and <NUM> form a single joined conductor bundle <NUM>. In some embodiments, the conductive filars <NUM> and <NUM>, but not the reinforcement filar, are surrounded by insulating sheaths <NUM>, <NUM>, and the multi-filar conductor bundle <NUM> is covered with the overcoating <NUM>.

The addition of a reinforcing filar <NUM> with a high tensile or high yield strength may increase the overall tensile strength of the multi-filar fine wire bundle <NUM>, while maintaining desirable electrical properties for the conductive filars <NUM> and <NUM>. This may for example permit pure copper to be used for the conductive filars <NUM> and <NUM> in place of copper alloys such as BeCu or AgCu, without compromising the mechanical strength of the multi-filar conductor bundle <NUM>, and with greatly reduced risk of elongation and necking that can break filars or limit their current-carrying capacity.

In some embodiments, the reinforcing filar <NUM> is not connected to electrical terminals at one or both ends of the multi-filar conductor bundle. High-strength stainless steel may have a substantially lower electrical conductivity (e.g., <NUM>-<NUM>% of the conductivity of pure copper), making it less desirable for use as an electrical conductor. However, in other instances, the reinforcing filar <NUM> may be employed as a conductor for certain applications. For example, in a filar that does not need to carry large currents or high-frequency signals (e.g., a signal ground wire), the lower conductivity of a reinforcing material (e.g., stainless steel) may be acceptable.

Other materials, whether conductive or not, may be employed instead of or in addition to stainless steel. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is shown with three filars arranged side-by-side in a planar fashion. However, other arrangements and other numbers of filars, whether conductive or reinforcing, may be employed instead or in addition. Furthermore, while the filars are shown as being circular in cross-section, some or all filars may be oval, rectangular, or curved in cross-section so as to minimize the profile of the multi-filar conductor bundle against a guidewire, catheter, or other device.

In some embodiments, the insulating sheaths <NUM>, <NUM>, <NUM> can be omitted. In such embodiments, the overcoating <NUM> can provide electrical isolation between the conductive filar <NUM>, the conductive filar <NUM>, and/or the reinforcing filar <NUM>.

<FIG> is a cross-sectional view of a multi-filar conductor bundle <NUM> in accordance with at least one embodiment of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a trifilar that includes two conductive filars <NUM> and <NUM>, surrounded by insulating sheaths <NUM> and <NUM>, respectively. In the example shown in <FIG>, the left outer filar of the bundle <NUM> is a reinforcement filar <NUM> that may or may not include an insulating sheath <NUM>. The reinforcement filar <NUM> can be located in any suitable position (e.g., the left position, the right position, the outer position, the central position, etc.). The multi-filar conductor bundle <NUM> may or may not include an additional overcoating <NUM> that joins the filars together to form a single conductor bundle <NUM>. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is shown with three filars arranged side-by-side in a planar fashion. However, other arrangements and other numbers of filars, whether conductive or reinforcing, may be employed instead or in addition.

<FIG> is a cross-sectional view of a multi-filar conductor bundle <NUM> in accordance with at least one embodiment of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a trifilar that includes two conductive filars <NUM> and <NUM>, surrounded by insulating sheaths <NUM> and <NUM>, respectively. In the example shown in <FIG>, the center filar of the bundle <NUM> is a reinforcement filar <NUM> that may or may not include an insulating sheath <NUM>. In this example, the multi-filar conductor bundle <NUM> does not include an additional overcoating <NUM> that joins the filars together. However, the filars <NUM>, <NUM>, and <NUM> may be tied, braided, or otherwise coupled to one another, or may simply be routed in a parallel but separate manner, wherein the reinforcement filar <NUM> helps to prevent the conductive filars <NUM> and <NUM> from elongating or necking during tensioning of the filars. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is shown with three filars arranged side-by-side in a planar fashion. However, other arrangements and other numbers of filars, whether conductive or reinforcing, may be employed instead or in addition.

<FIG> is a cross-sectional view of a multi-filar conductor bundle <NUM> in accordance with at least one embodiment of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a trifilar that includes two conductive filars <NUM> and <NUM>, surrounded by insulating sheaths <NUM> and <NUM>, respectively. In the example shown in <FIG>, the left outer filar of the bundle <NUM> is a reinforcement filar <NUM> that may or may not include an insulating sheath <NUM>. In this example, the multi-filar conductor bundle <NUM> does not include an additional overcoating <NUM> that joins the filars together. However, the filars <NUM>, <NUM>, and <NUM> may be otherwise coupled to one another, or routed in a parallel but separate manner, wherein the reinforcement filar <NUM> helps to prevent the conductive filars <NUM> and <NUM> from elongating or necking. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is shown with three filars arranged side-by-side in a planar fashion. However, other arrangements and other numbers of filars, whether conductive or reinforcing, may be employed instead or in addition.

<FIG> is a cross-sectional view of a multi-filar conductor bundle <NUM> in accordance with at least one embodiment of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a trifilar that includes two conductive filars <NUM> and <NUM>, surrounded by insulating sheaths <NUM> and <NUM>, respectively. In the example shown in <FIG>, the one filar of the bundle <NUM> is a reinforcement filar <NUM> that may or may not include an insulating sheath <NUM>. The multi-filar conductor bundle <NUM> may or may not include an additional overcoating <NUM> that joins the filars together to form a single joined conductor bundle <NUM>. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is shown with three filars arranged in a triangular fashion. However, other arrangements and other numbers of filars, whether conductive or reinforcing, may be employed instead or in addition. Although a flat (side-by-side) arrangement of conductors may minimize the profile of the conductor bundle against a catheter, guidewire, or other device, a stacked (e.g., triangular, rectangular, etc.) arrangement may be advantageous or desirable for other reasons, depending on the implementation.

<FIG> is a cross-sectional view of a multi-filar conductor bundle <NUM> in accordance with at least one embodiment of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a trifilar that includes two conductive filars <NUM> and <NUM>, surrounded by insulating sheaths <NUM> and <NUM>, respectively. In the example shown in <FIG>, the center filar of the bundle <NUM> is a reinforcement filar <NUM> with a larger diameter than the conductive filars <NUM> and <NUM>. In the illustrated embodiment, the reinforcement filar <NUM> comprises a different material with a relatively higher strength than the materials used for the conductive filars <NUM>, <NUM> and is surrounded by an insulating sheath <NUM>. In other embodiments, the reinforcement filar <NUM> is made of the same material as the conductive filars <NUM> and <NUM>. In some embodiments, the reinforcement filar <NUM> does not include the insulating sheath <NUM>. The multi-filar conductor bundle <NUM> may or may not include an additional overcoating <NUM> that joins the filars together to form a single conductor bundle <NUM>.

The tensile strength or yield strength of a filar may be dependent on its composition. The total force required to elongate, neck, or otherwise deform a filar may be dependent on the diameter of the filar, and therefore the addition of a reinforcing filar <NUM>, with a larger diameter than that of the conductive filars <NUM> and <NUM>, may increase the total force on the multi-filar fine wire bundle <NUM> that is required to elongate or neck the conductive filars of the multi-filar fine wire bundle <NUM>. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is shown with three filars arranged side-by-side in a planar fashion. However, other arrangements and other numbers of filars, whether conductive or reinforcing, may be employed instead or in addition. Although a flat (side-by-side) arrangement of same-size conductors may minimize the profile of the conductor bundle against a catheter, guidewire, having one or more conductors of larger diameter may be advantageous or desirable for other reasons, depending on the implementation.

<FIG> is a diagrammatic side view of an intravascular device <NUM> comprising a reinforced multi-filar electrical conductor bundle <NUM>, in accordance with at least one embodiment of the present disclosure. Visible are the proximal core wire <NUM> and distal core wire <NUM>, joined by a hypotube <NUM>. At the distal end of the distal core wire is a coil <NUM> that terminates with an electronic device <NUM> that may be fully or partially enclosed within a housing <NUM>. Also visible is a reinforced multi-filar conductor bundle <NUM> that includes conductive filars <NUM> and <NUM>, and a reinforcement filar <NUM>.

The conductive filars <NUM> and <NUM> connect the electronic component <NUM> with electrical contacts <NUM> formed on the conductive ribbons <NUM> that make electrical contact with the conductive regions <NUM> and <NUM>. The reinforced multi-filar conductor bundle <NUM> includes a straight region <NUM> that passes through the coil <NUM>. The reinforced multi-filar conductor bundle <NUM> also includes a helical region <NUM> that wraps around the distal core wire <NUM> and is overcoated with an insulative or protective polymer coating <NUM>. In the helical region <NUM>, the filars of <NUM>, <NUM>, <NUM> of the bundle extend in parallel around the distal core wire <NUM> such that the helical shape formed by the filars <NUM>, <NUM>, <NUM> is concentric with the distal core wire <NUM>. The filars <NUM>, <NUM>, <NUM> are shown extending in contact with one another. In this regard, the filars <NUM>, <NUM>, <NUM> may be attached to one another, or unattached to one another such that the filars <NUM>, <NUM>, <NUM> extend adjacent to one another. The reinforced multi-filar conductor bundle <NUM> additionally includes a straight region <NUM> that passes through the hypotube <NUM>. Between the hypotube <NUM> and the electrical contacts <NUM>, the conductive filars are overcoated with a polymer coating <NUM>. In some embodiments, the electrical contacts <NUM> are formed by removing (e.g., etching, ablating) a portion of an outer insulating coating or layer covering the ribbons <NUM>, and soldering the conductive filars <NUM>, <NUM> to the ribbons <NUM>.

In the example shown in <FIG>, the reinforcement filar <NUM> is present within the multi-filar conductor bundle <NUM> in the helical region <NUM>, but not in the straight regions <NUM> and <NUM>. A distal end of the reinforcement filar <NUM> ends at a location <NUM>. Location <NUM> is proximal of a distal end of the distal core wire <NUM>. Location <NUM> can be aligned for example with a location where a tapering at a distal portion of the distal core wire <NUM> begins. A proximal end of the reinforcement filar <NUM> ends at a location <NUM>. Location <NUM> is distal of a proximal end of the distal core wire <NUM>. Location <NUM> can be aligned for example with a location where a tapering at a proximal portion of the distal core wire <NUM> begins. The reinforcement filar may for example be clipped, skived, or bent at locations <NUM> and <NUM> such that it is separated from the conductive filars <NUM> and <NUM> at these locations, such that it provides strength to the multi-filar conductor bundle <NUM> in processing-intensive regions such as the helical region <NUM>, but does not interfere with fine assembly operations at the electrically terminated ends, and does not add unwanted stiffness to the coil <NUM>. The multi-filar conductor bundle <NUM> may also be easier to feed through certain couplings with the reinforcement filar <NUM> removed.

<FIG> is a is a diagrammatic side view of an intravascular device <NUM> comprising a multi-filar electrical conductor bundle <NUM>, in accordance with at least one embodiment of the present disclosure. Visible are the proximal core wire <NUM> and distal core wire <NUM>, joined by a hypotube <NUM>. At the distal end of the distal core wire is a coil <NUM> that terminates with an electronic device <NUM> that is fully or partially enclosed in a housing <NUM>. Also visible is a reinforced multi-filar conductor bundle <NUM> that includes conductive filars <NUM> and <NUM>, and a reinforcement filar <NUM>.

The conductive filars <NUM> and <NUM> connect the electronic component <NUM> with electrical contacts <NUM> formed on the conductive ribbons <NUM> that make electrical contact with the conductive regions <NUM> and <NUM>. The reinforced multi-filar conductor bundle <NUM> includes a straight region <NUM> that passes through the coil <NUM>. The reinforced multi-filar conductor bundle <NUM> also includes a helical region <NUM> that wraps around the distal core wire <NUM> and is overcoated with a polymer coating <NUM>. The reinforced multi-filar conductor bundle <NUM> additionally includes a straight region <NUM> that passes through the hypotube <NUM>. Between the hypotube <NUM> and the electrical contacts <NUM>, the conductive filars are overcoated with a polymer coating <NUM>.

In the example shown in <FIG>, the reinforcement filar <NUM> is present in the helical region <NUM>, and also in the straight regions <NUM> and <NUM>, but is not electrically terminated at either end. In other embodiments, the reinforcement filar <NUM> may be employed as a conductor, and may be electrically terminated for example at the electronic device on its distal end, and at an electrical connection <NUM> at its proximal end.

<FIG> is a schematic diagram of a processor circuit <NUM>, according to at least one embodiment of the present disclosure. The processor circuit <NUM> may be implemented in the intravascular sensing system <NUM>, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to implement the method. As shown, the processor circuit <NUM> may include a processor <NUM>, a memory <NUM>, and a communication module <NUM>. These elements may be in direct or indirect communication with each other, for example via one or more buses.

The processor <NUM> may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general-purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. The processor <NUM> may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein.

The memory <NUM> may include a cache memory (e.g., a cache memory of the processor <NUM>), 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 device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, the memory <NUM> includes a non-transitory computer-readable medium. The instructions <NUM> may include instructions that, when executed by the processor <NUM>, cause the processor <NUM> to perform the operations described herein. Instructions <NUM> may also be referred to as code. The terms "instructions" and "code" should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms "instructions" and "code" may refer to one or more programs, routines, sub-routines, functions, procedures, etc. "Instructions" and "code" may include a single computer-readable statement or many computer-readable statements.

The communication module <NUM> can include any electronic circuitry and/or logic circuitry to facilitate direct or indirect communication of data between the processor circuit <NUM>, and other processors or devices. In that regard, the communication module <NUM> can be an input/output (I/O) device. In some instances, the communication module <NUM> facilitates direct or indirect communication between various elements of the processor circuit <NUM> and/or the intravascular measurement system <NUM>. The communication module <NUM> may communicate within the processor circuit <NUM> through numerous methods or protocols. Serial communication protocols may include but are not limited to US SPI, I<NUM>C, RS-<NUM>, RS-<NUM>, CAN, Ethernet, ARINC <NUM>, MODBUS, MIL-STD-<NUM>, or any other suitable method or protocol. Parallel protocols include but are not limited to ISA, ATA, SCSI, PCI, IEEE-<NUM>, IEEE-<NUM>, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a UART, USART, or other appropriate subsystem.

External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the ultrasound device) may be accomplished 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 cellular data connections such as <NUM>/GSM, <NUM>/UMTS, <NUM>/LTE/WiMax, or <NUM>. For example, a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches. The controller may 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 status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.

<FIG> is a cross-sectional view of a multi-filar conductor bundle <NUM> in accordance with at least one embodiment of the present disclosure. In the example shown in <FIG>, the multi-filar conductor bundle <NUM> is a quadrufilar that includes two conductive filars <NUM> and <NUM>, surrounded by insulating sheaths <NUM> and <NUM>, respectively. In the example shown in <FIG>, the center two filars of the bundle <NUM> are reinforcement filars <NUM>, each of which may or may not include an insulating sheath <NUM>. The multi-filar conductor bundle <NUM> may or may not include an additional overcoating <NUM> that joins the filars together to form a single conductor bundle <NUM>.

Accordingly, it can be seen that the reinforced multi-filar conductor bundle advantageously increases the strength of multi-filar conductor bundles that may be used in the manufacture of small electronic devices such as intravascular medical catheters and guidewires. A number of variations are possible on the examples and embodiments described above. For example, multiple reinforcing filars, of the same or different types, may be included in a multi-filar conductor bundle, or all of the filars in a multi-filar conductor bundle or cable may be reinforcement type filars.

The logical operations making up the embodiments of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may be arranged or performed in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language. It should further be understood that the described technology may be employed in single-use and multi-use electrical and electronic devices for medical or nonmedical use.

All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader's understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the reinforced multi-filar conductor bundle. Connection references, e.g., attached, coupled, connected, and joined are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term "or" shall be interpreted to mean "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 noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

Claim 1:
An intraluminal sensing guidewire, comprising:
a flexible elongate member (<NUM>) configured to be positioned within a body lumen of a patient, wherein the flexible elongate member comprises a metallic core wire extending along a longitudinal axis;
a sensing element (<NUM>) disposed at a distal portion of the flexible elongate member and configured to obtain physiological data while positioned within the body lumen;
a conductive ribbon (<NUM>) disposed at a proximal portion of the flexible elongate member; and
a filar bundle (<NUM>) comprising:
a first conductive filar (<NUM>) comprising a first material strength, wherein the first conductive filar is configured for electrical communication with the sensing element;
a first reinforcement filar (<NUM>) comprising a second material strength greater than the first material strength.