Patent Description:
Diagnostic and therapeutic ultrasound catheters have been designed for use inside many areas of the human body. In the cardiovascular system, a common diagnostic ultrasound methods is intraluminal ultrasound imaging with intra-cardiac echocardiography (ICE) being a specific example of intraluminal imaging. Typically, a single rotating transducer or an array of transducer elements is used to transmit ultrasound at the tips of the catheters. The same transducers are used to receive echoes from the tissue. A signal generated from the echoes is transferred to a console which allows for the processing, storing, display, or manipulation of the ultrasound-related data.

Intraluminal imaging catheters, such as ICE catheters (e.g., Siemens Acunav, St. Jude ViewFlex), are generally used to image heart and surrounding structures, for example, to guide and facilitate medical procedures, such as transseptal lumen punctures, left atrial appendage closures, atrial fibrillation ablation, and valve repairs. Commercially-available ICE catheters have distal ends which can be articulated by a steering mechanism located in a handle at the proximal end of the catheter. For example, an intraluminal imaging catheter such as an ICE catheter may be inserted through the femoral or jugular vein when accessing the anatomy, and steered in the heart to acquire images necessary to the safety of the medical procedures.

An ICE catheter may include electrical wires that are connected to an imaging assembly at the distal portion of the catheter and that transmit electrical signals representative of commands or ultrasound data. Generally, the imaging assembly is larger than an internal cavity of the catheter, such that the imaging core cannot be passed or sneaked through the internal cavity. Therefore, the electrical wires are sneaked through the catheter before the imaging core is attached to the catheter wire. However, the catheter may be damaged during handling after the imaging assembly is attached. For example, manufacturing steps on the imaging assembly (such as precise alignment, bonding, wirebonding, and overcoating) may cause damage the delicate catheter. Furthermore, the electrical wires and imaging assembly may require multiple testing steps after being assembled to ensure quality.

<CIT> and <CIT> disclose known ultrasound intraluminal devices having a cable assembly for forming a connection with a ultrasonic transducer housed in a catheter.

An ultrasound imaging system is provided by the present disclosure. The ultrasound imaging system can include a catheter assembly. The catheter assembly may include a distal portion, a proximal portion, and a cable extending between the distal and proximal portions. The cable includes a plurality of electrical wires that facilitate electrical signal communication between the ultrasound imaging assembly at the distal portion and an electronic component, such as a printed circuit board (PCB), at the proximal distal. The PCB can be part of a low profile proximal connector that is sized and shaped for passing through a catheter body after the electrical wires are attached. In that regard, the electrical wires can be attached to the connector at an angle relative to the orientation of the connector. The angled connection advantageously allows a more robust interconnection that is less prone to breaking while the PCB and electrical wires are passed through the entire length of the catheter body during manufacturing. This may reduce waste and help to alleviate manufacturing problems. The interconnection also allows for testing of the electrical connections during assembly of the catheter.

A system is provided by the present disclosure, which may include: an intraluminal device configured to be positioned within a body lumen of a patient, the intraluminal device comprising a proximal portion and a distal portion, wherein the intraluminal device further comprises: a sensor disposed at the distal portion; a proximal connector comprising a printed circuit board assembly (PCBA) configured to interface with a user console and disposed at the proximal portion; and a plurality of electrical wires connecting the sensor and the proximal connector, wherein the plurality of electrical wires are terminated at an angle on the PCBA such that the PCBA and electrical wires terminated thereon together are configurable to form a cross-section of <NUM><NUM> or less.

In some aspects, the intraluminal device further comprises a sheath disposed around at least a portion of the plurality of wires and terminating on the PCBA. In some aspects, the sheath is braided. In some aspects, a length of the sheath prior to terminating at the PCBA is not disposed around the plurality of wires such that the length of the sheath runs parallel to a length of the wires. In some aspects, the sheath is terminated on the PCBA at a position distal to the termination of the plurality of electrical wires. In some aspects, the plurality of electrical wires are arranged to be foldable when the intraluminal device is passed through a catheter body. In some aspects, the angle is between <NUM> degrees and <NUM> degrees with respect to an orientation of the PCBA. In some aspects, the angle is between <NUM> and <NUM> degrees with respect to an orientation of the PCBA. In some aspects, each of the plurality of electrical wires is soldered onto a contact of the PCBA. In some aspects, the plurality of electrical wires are soldered along one or more lines extending a length of the PCBA. In some aspects, the wires are soldered along single line along a length of the PCBA. In some aspects, the plurality of electrical wires pass through an opening distal of the proximal portion of the intraluminal device. In some aspects, the intraluminal device comprises a knitted outer portion, wherein the opening is in the knitted outer portion. In some aspects, a proximal end of the knitted outer portion is coupled to a distal end of the PCBA.

A cabling assembly for a catheter is provided by the present disclosure. The cabling assembly defines a length between proximal and distal portions of the cabling assembly. The cabling assembly may include a sensor disposed at the distal portion; a printed circuit board assembly (PCBA) disposed at the proximal portion; and a cable connecting the sensor and the PCBA and comprising a plurality of electrical wires, wherein the plurality of electrical wires are angled with respect to the PCBA such that the PCBA and electrical wires together form a cross-section of <NUM><NUM> or less.

In some aspects, the electrical wires are configured to move from a first position when placed in a shaft of the catheter to a second position when extending out of the shaft of the catheter.

A method of assembling an intraluminal ultrasound imaging device is provided by the present disclosure, which may include: coupling a distal portion of cable to an ultrasound transducer configured to obtain imaging data of a body lumen of a patient, the cable comprising a plurality of electrical wires; and coupling a proximal portion of the cable to a printed circuit board assembly (PCBA), wherein the plurality of electrical wires are terminated at an angle with respect to an orientation of the PCBA; and after attaching the cable to the ultrasound transducer and the PCBA, passing the PCBA and the cable through a catheter shaft; and coupling the PCBA to a proximal connector configured to interface with a patient interface module (PIM).

In some aspects, attaching the PCBA to the proximal connector comprises connecting the PCBA to a further PCBA within the proximal connector. In some aspects, passing the PCBA and the cable through the catheter shaft includes folding the electrical wires towards the PCBA. In some aspects, the angle is between <NUM> degrees and <NUM> degrees with respect to the orientation of the PCBA. In some aspects, the angle is between <NUM> and <NUM> degrees with respect to the orientation of the PCBA. In some aspects, coupling the proximal portion of the cable to the PCBA includes soldering each of the plurality of electrical wires onto a contact of the PCBA. In some aspects, coupling the proximal portion of the cable to the PCBA includes soldering the plurality of electrical wires along a single line extending across the PCBA. In some aspects, the method further includes passing the plurality of electrical wires through an opening distal of a proximal end of the cable. In some aspects, the cable comprises a knitted outer portion, and wherein passing the plurality of electrical wires through the opening includes passing the plurality of electrical wires through an opening in the knitted outer portion. In some aspects, the method further includes attaching a proximal end of the knitted outer portion of the cable to a distal end of the PCBA.

Reference is done to imperial units in some passages of the following description, where the conversion table to the corresponding SI/metric units is:.

For example, while the ICE system is described in terms of intraluminal imaging, it is understood that it is not intended to be limited to this application.

<FIG> is a schematic diagram of an imaging system <NUM> according to embodiments of the present disclosure. The system <NUM> may include an intraluminal ultrasound imaging device <NUM>, a control and processing system <NUM> (for example, a console including a computer), and a patient interface module (PIM) <NUM> extending between the device <NUM> and the control and processing system <NUM>.

The ultrasound imaging device <NUM> may include a catheter <NUM>, which is shown in more detail in <FIG>. The catheter <NUM> may include one or more flexible elongate members sized and shaped, structurally arranged, and/or otherwise configured to be positioned within a body lumen of a patient. In some embodiments, the catheter <NUM> includes an ultrasound imaging assembly <NUM>, a catheter body or shaft <NUM>, a catheter cable <NUM>, a handle <NUM>, a conduit <NUM>, a connector <NUM>, and one or more printed circuit board assemblies (PCBAs) <NUM>. The catheter cable <NUM> may have a small diameter configuration and a low profile that is sized to be passed or sneaked through a catheter shaft <NUM>, the handle <NUM>, and/or the conduit <NUM>. The cable <NUM> may be electrically and/or mechanically coupled to the ultrasound imaging assembly <NUM> at the distal portion of the catheter shaft <NUM>, as well as the PCBA <NUM> at the proximal portion of the catheter <NUM>.

In some embodiments, one or both of the catheter body/shaft <NUM> and catheter cable <NUM> may be referred to as a flexible elongate member. The catheter shaft <NUM> is sized and shaped, structurally arranged and/or otherwise configured to be positioned within a body lumen of a patient (e.g., vasculature such as blood vessels or chambers of the heart). Respective portions of the catheter cable <NUM> extend within the catheter shaft <NUM>, the handle <NUM>, the conduit <NUM>, and the connector <NUM>. The imaging assembly <NUM> may be attached it a distal end of the catheter shaft <NUM>. The catheter shaft <NUM> may include a lumen that the catheter cable <NUM> may pass through. The proximal end <NUM> of the catheter shaft <NUM> may be attached to the handle <NUM>, for example, by a resilient strain reliever. The handle <NUM> may be used for manipulation of the ultrasound imaging device <NUM> and manual control of the ultrasound imaging device <NUM>. The ultrasound imaging device <NUM> may include an imaging assembly <NUM> with ultrasound transducer elements and associated circuitry. The handle <NUM> may include actuators <NUM>, a clutch <NUM>, and other steering control components for steering the ultrasound imaging device <NUM>. The steering may include deflecting the distal end of the catheter cable <NUM>, as described in greater details herein.

The catheter cable <NUM> may pass through one or more of the catheter shaft <NUM>, handle <NUM>, conduit <NUM>, and connector <NUM>. In some embodiments, during assembly, the catheter cable <NUM> is sneaked through a lumen within the catheter body <NUM>, handle <NUM>, and conduit <NUM>. In some embodiments, the conduit <NUM> is a component distinct from the cable <NUM>. For example, the conduit can be a tubing within which the cable <NUM> extends. In other embodiments, the conduit <NUM> can be a coating defining an exterior surface of the cable <NUM>. The coating can strengthen the cable <NUM> for exposure to direct contact and/or handling by an operator of the catheter <NUM>. The catheter cable <NUM> may be terminated at a PCBA <NUM> within the connector <NUM>. The catheter cable <NUM> may be electrically and mechanically coupled to the imaging assembly <NUM> and may include a plurality of electrical wires.

The handle <NUM> may be connected to the conduit <NUM> via another strain reliever. The conduit <NUM> may be configured to provide suitable configurations for interconnecting the control and processing system <NUM> and the monitor <NUM> to the imaging assembly <NUM>. The control and processing system <NUM> may be used for processing, storing, analyzing, and manipulating data, and the monitor <NUM> may be used for displaying obtained signals generated by the imaging assembly <NUM>. The control and processing system <NUM> can include one or more processors, memory, one or more input devices, such as keyboards and any suitable command control interface device. The control and processing system <NUM> may be operable to facilitate the features of the intraluminal imaging system <NUM> described herein. For example, a processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium. The monitor <NUM> may be any suitable display device, such as liquid-crystal display (LCD) panel or the like.

In operation, a physician or a clinician may advance the catheter <NUM> into a lumen, such as a blood vessel, body lumen, or portion of a heart anatomy. By controlling actuators <NUM> and/or the clutch <NUM> on the handle <NUM>, the physician or clinician may steer the catheter <NUM> to a position near the area of interest to be imaged. For example, one actuator may deflect the imaging assembly <NUM> and a distal end of the catheter cable <NUM> in a left-right plane and the other actuator may deflect the imaging assembly <NUM> and the distal end of the catheter cable <NUM> in an anterior-posterior plane. The clutch <NUM> may provide a locking mechanism to lock the positions of the actuators <NUM> and in effect lock the deflection of the imaging assembly <NUM> while imaging the area of interest.

The imaging process may include activating the ultrasound transducer elements on the imaging assembly <NUM> to produce ultrasonic energy. A portion of the ultrasonic energy is reflected by the area of interest and the surrounding anatomy, and the ultrasound echo signals are received by the ultrasound transducer elements. The conduit <NUM> may be used to transfer the received echo signals to the control and processing system <NUM> where the ultrasound image is reconstructed and displayed on the monitor <NUM>. In some embodiments, the processing system <NUM> can control the activation of the ultrasound transducer elements and the reception of the echo signals. In some embodiments, the control and processing system <NUM> and the monitor <NUM> may be part of a same system.

While some embodiments of the present disclosure refer to an imaging device, an ultrasound imaging device, or an intraluminal imaging device, it is understood that the ultrasound imaging device <NUM> and the system <NUM> generally may be used to image vessels, structures, lumens, and/or any suitable anatomy/tissue within a body of a patient including 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 imaging device <NUM> may be may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices. For example, the ultrasound imaging device <NUM> can be positioned within fluid filled or surrounded structures, both natural and man-made, such as within a body of a patient. The vessels, structures, lumens, and anatomy/tissue can include a blood vessel, as an artery or a vein of a patient's vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or any suitable lumen inside the body.

The system <NUM> can be referenced as an imaging system, ultrasound imaging system, intraluminal imaging system, and/or combinations thereof. Although the present disclosure refers to ICE catheters, any suitable intraluminal imaging device is contemplated, such as an intravascular ultrasound (IVUS) device, an optical coherence tomography (OCT) device, an intracardiac echocardiography (ICE) device, a transesophageal echocardiography (TEE) device, an intravascular photoacoustic (IVPA) imaging device, and/or any suitable internal imaging device. Intraluminal devices with flexible elongate members such as catheters, guide wires, and/or guide catheter are contemplated.

The system <NUM> may be utilized in a variety of applications such as transseptal punctures, left atrial appendage closures, atrial fibrillation ablation, and valve repairs and can be used to image vessels and structures within a living body. Although the system <NUM> is described in the context of intraluminal imaging procedures, the system <NUM> is suitable for use with any catheterization procedure. In addition, the imaging assembly <NUM> may include any suitable physiological sensor or component for diagnostic, treatment, and/or therapy. For example, the imaging assembly can include an imaging component, an ablation component, a cutting component, a morcellation component, a pressure-sensing component, a flow-sensing component, a temperature-sensing component, and/or combinations thereof. In some embodiments, the intraluminal imaging system <NUM> is used for generating two-dimensional and three-dimensional images.

Referring back to <FIG>, the PIM <NUM> may provide a physical and electrical connection between the ultrasound imaging device <NUM> and the control and processing system <NUM>. Some embodiments of the present disclosure omit the PIM <NUM>. In other embodiments, the PIM <NUM> is communicatively interposed between the ultrasound imaging device <NUM> and the processing system <NUM>. In some instances, the PIM <NUM> can be referenced as a patient interface cable. For example, a proximal connector <NUM> of the ultrasound imaging device <NUM>, a distal connector of the PIM, and/or a proximal connector of the PIM may be configured to couple the ultrasound imaging device <NUM>, the PIM <NUM>, and the control and processing system together mechanically and electrically. The system <NUM> may include may include a connector junction <NUM> comprising a proximal connector <NUM> of the ultrasound imaging device <NUM> and the distal connector of the PIM <NUM>.

In some embodiments, the control and processing system <NUM> may include one or more computers, processors, and/or computer systems. The control and processing system <NUM> may also be referred to as a console. In some embodiments, the PIM <NUM> is in mechanical and electrical communication with the control and processing system <NUM>, such that the electrical signals are transmitted the ultrasound imaging device <NUM> through the PIM <NUM> and to the control and processing system <NUM>. The control and processing system <NUM> may include one or more processors and/or memory modules forming a processing circuit that may process the electrical signals and output a graphical representation of the imaging data on the monitor <NUM>. One or more electrical conductors of the ultrasound imaging device <NUM> and PIM <NUM> may facilitate communication between the control and processing system <NUM> and the ultrasound imaging device <NUM>. For example, a user of the control and processing system <NUM> may control imaging using the ultrasound imaging device <NUM> via a control interface <NUM> of the control and processing system <NUM>. Electrical signals representative of commands from the control and processing system <NUM> may be transmitted to the ultrasound imaging device <NUM> via connectors and/or cables in the PIM <NUM> and the ultrasound imaging device <NUM>. The control and processing system <NUM> may be transportable and may include wheels or other devices to facilitate easy transportation by a user.

In some embodiments, the one or more components of the ultrasound imaging device <NUM> may be disposable components. For example, a user, such as a physician, may obtain the catheter <NUM> and/or the ultrasound imaging device <NUM> in a sterilized packaging. In some embodiments, the ultrasound imaging device <NUM> may be disposed after a single use. In other embodiments, the ultrasound imaging device <NUM> can be sterilized and/or re-processed for more than one use. The PIM <NUM> may be a re-usable component that is used in multiple procedures. For example, the PIM <NUM> can be cleaned between individual procedures, such as being treated with disinfectants to kill bacteria. In some embodiments, the PIM <NUM> may not be required to be sterilized before a medical procedure. For example, the PIM <NUM> can be sufficiently spaced from the patient such that use of a non-sterile PIM <NUM> is safe for the patient. The sterile-nonsterile connection at the connector assembly <NUM> between the ultrasound imaging device <NUM> and the PIM <NUM> may allow for a safe operating environment while saving costs by allowing expensing equipment to be reused.

<FIG> is a perspective view of the catheter cable <NUM> described above with respect to <FIG>. The catheter cable <NUM> is flexible elongate body <NUM> including a plurality of communication cables allow communication of imaging data and/or command signals between the processing system <NUM> and the catheter <NUM>. The communication cables can be electrical wires. An individual electrical wire can include a bare conductor surrounded by one or more insulating layer(s) and/or shielding layer(s). The plurality of electrical wires collectively can be surrounded by one or more insulating layers(s) and/or shielding layer(s). An insulating layer may be formed of any suitable materials, such as a plastic or a polymer in some instances. A shield layer may be formed of any suitable material, such as a metal in some instances. For example, a woven layer <NUM>, such as an RFI braid can surround the electrical wires. The cable <NUM> extends between the ultrasound imaging assembly <NUM> disposed at a distal portion <NUM> and PCBA <NUM> at a proximal portion <NUM>. The flexible elongate body <NUM> extends between the distal end <NUM> and the proximal end <NUM>. In some embodiments, the imaging assembly <NUM> is electrically and/or mechanically coupled (e.g., adhered or bonded) to distal end <NUM>. During manufacturing, the imaging assembly <NUM> may be coupled to the catheter cable <NUM>, prior to the cable <NUM> be sneaked through the catheter body or shaft. In some embodiments, the catheter cable <NUM> is about <NUM> feet long. In other embodiments, the catheter cable <NUM> is between <NUM> and <NUM> feet long or between <NUM> and <NUM> feet long, and/or other suitable values both larger and smaller.

<FIG> shows a cross-sectional view of a catheter shaft <NUM>. The catheter shaft <NUM> is sized and shaped, structurally arranged, and/or otherwise configured to be positioned within the body lumen of a patient during the imaging procedure. The catheter cable <NUM> (as shown in <FIG> and <FIG>) may be configured to be disposed within an internal lumen <NUM> of the catheter shaft <NUM>. The catheter shaft <NUM> may include a number of pullwire lumens <NUM> disposed within the catheter shaft <NUM>. Pull wires positioned within the lumens <NUM> control movement (deflection of the distal tip) of the distal portion of the catheter shaft and/or the imaging assembly <NUM>. In some embodiments, the catheter shaft <NUM> has an outer diameter between approximately <NUM> and approximately <NUM>, including values both larger and smaller. In an exemplary embodiment, the catheter shaft <NUM> has an outer of about <NUM> (+/- <NUM>).

<FIG> shows a cross-sectional view of a catheter cable <NUM>. The catheter cable <NUM> (e.g., the PCBA <NUM> and the flexible elongate body <NUM>) may sneaked or passed through the catheter shaft <NUM> during assembly. The PCBA <NUM> can be configured to directly or indirectly interface with a user console. For example, the PCBA <NUM> can be in direct or indirect communication with the console or processing system <NUM> and/or the PIM <NUM> (<FIG>). In some embodiments, the catheter cable <NUM> has a diameter between approximately <NUM> and approximately <NUM>, including values both larger and smaller. In an exemplary embodiment, the catheter cable <NUM> has a diameter of about <NUM> (+/- <NUM>). In some embodiments, the catheter cable <NUM> may include a polymer layer <NUM>, a shielding layer <NUM>, and a number of electrical wires <NUM>. The electrical wires <NUM> may be disposed within the shielding layer <NUM> which may be disposed within the polymer layer <NUM>. The electrical wires <NUM> may be used to communicate signals from the imaging assembly to the proximal end <NUM>, and ultimately to the processing system <NUM>. In some embodiments, the shield layer <NUM> can be the woven layer <NUM> disposed around the polymer layer <NUM>, as shown in <FIG>. The electrical wires <NUM> connect the imaging assembly <NUM> and the proximal connector <NUM> (e.g., PCBA <NUM>).

<FIG> is a perspective view of the imaging assembly <NUM> according to embodiments of the present disclosure. The imaging assembly <NUM> is positioned at the distal portion of the catheter shaft <NUM> after assembly. The imaging assembly <NUM> is also positioned at the distal portion of the cable <NUM>. The imaging assembly <NUM> may include an ultrasound transducer array <NUM> that includes a number of transducer elements and a micro-beam-former IC <NUM> that can be coupled to the transducer array <NUM>. The electrical wires <NUM> of the cable <NUM> are mechanically and/or electrical coupled to the imaging assembly <NUM>. In some examples, the electrical cable <NUM> is further coupled through an interposer <NUM> to the micro-beam-former IC <NUM>. In some examples the interposer <NUM> is connected to the micro-beam-former IC <NUM> through wire bonding <NUM>. The wires <NUM> of the cable <NUM> are directly or indirectly in communication with the transducer array <NUM>, the IC <NUM>, and/or the interposer <NUM>.

In some embodiments, the transducer array <NUM> includes ultrasound imaging transducers that are directly flip-chip mounted to the micro-beam-former IC <NUM>. The transmitters and receivers of the ultrasound imaging transducers are on the micro-beam-former IC <NUM> and are directly attached to the transducers. In some examples, a mass termination of the acoustic elements is done at the micro-beam-former IC <NUM>.

In some examples, the transducer array <NUM> includes more than <NUM> imaging elements and the electrical cable <NUM> includes a total of <NUM> signal lines or less. In some examples, the electrical cable <NUM> includes a total of <NUM> lines or less that includes the signal lines, power lines, and control lines. In some examples, the transducer array <NUM> includes a one-dimensional or two-dimensional array from between <NUM> to <NUM> imaging elements. For example, the array can include <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or any other suitable number of imaging elements. For example, a one-dimensional array may have <NUM> imaging elements. A two-dimensional array may have <NUM>, <NUM>, or more imaging elements. In some examples, the number of signal lines is between <NUM> and <NUM>, for example, <NUM> signal lines, <NUM> signal lines, or any other suitable number of signal lines. A one-dimensional array can be configured to generate two-dimensional images. A two-dimensional array can be configured to generate two-dimensional and/or three-dimensional images.

In some examples, the electrical cable <NUM> of the imaging assembly <NUM> is directly coupled to the micro-beam-former IC <NUM> of the imaging assembly <NUM>. In some embodiments, the micro-beam-forming IC <NUM> lies directly underneath the transducer array <NUM> and is electrically connected to them. The elements of the transducer array <NUM> may be piezoelectric or micromachined ultrasonic transducer (MUT) elements. In some examples, piezoelectric elements are attached to the IC <NUM> by flip-chip mounting of an assembly of acoustic layers that include sawing into individual elements. MUT elements may be flip-chip mounted as a unit or grown directly on top of the micro-beam-forming IC <NUM>. In some examples, the cable bundle may be terminated directly to the micro-beam-forming IC <NUM>, or may be terminated to an interposer <NUM> of suitable material such as a rigid or flexible printed circuit assembly. The interposer <NUM> may then be connected to the micro-beam-forming IC <NUM> via any suitable means such as wire bondings <NUM>.

<FIG> is a perspective view of the proximal portion <NUM> of the catheter cable <NUM>. In some embodiments, the proximal portion <NUM> includes a proximal portion <NUM> of the flexible elongate body <NUM> in communication with the PCBA <NUM> and a transition portion <NUM> connecting the proximal portion <NUM> and the connector <NUM>. The connector <NUM> can be in the form of PCBA <NUM>. The transition portion <NUM> may include a plurality of electrical wires <NUM> that are attached to a substrate <NUM> of the connector <NUM>. In some embodiments, the substrate <NUM> may have a length L1 of approximately <NUM> inches. The length L1 may be between <NUM> and <NUM> inches, between <NUM> and <NUM> inches, or between <NUM> and <NUM> inches, and/or other values both larger and smaller. The substrate <NUM> may have a width W1 of approximately <NUM> inches. The width W1 may be between <NUM> and <NUM> inches, between <NUM> and <NUM> inches, or between <NUM> and <NUM> inches, and/or other values both larger and smaller. The substrate <NUM> generally extends lengthwise or longitudinally, without a large width. The small size of the substrate <NUM> and fine electrical wires <NUM> may provide for a smaller PCBA <NUM> within the connector <NUM> and allow the proximal end <NUM> to be sneaked through a catheter after assembly.

<FIG> is a magnified view <NUM> of the transition portion <NUM> shown in <FIG>. The electrical wires <NUM> may be seen extending from the flexible elongate body <NUM> to the substrate <NUM>. In some embodiments, the transition portion <NUM> includes <NUM> electrical wires <NUM>. In other embodiments, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, and/or other quantities of electrical wires <NUM> are included in the transition portion <NUM>. The electrical wires <NUM> may be passed through the body <NUM> from imaging assembly <NUM> to the PCBA <NUM>. In some embodiments, the electrical wires <NUM> are attached to the substrate <NUM> at an angle.

For example, <FIG> shows a further magnified view of the electrical wires <NUM> attached to the substrate <NUM>. In some embodiments, the electrical wires <NUM> are attached at an angle α with reference to the orientation of the substrate <NUM>. For example, angle α may measure between <NUM> and <NUM> degrees, between <NUM> and <NUM> degrees, between <NUM> and <NUM> degrees, between <NUM> and <NUM> degrees, between <NUM> and <NUM> degrees, or between <NUM> and <NUM> degrees, including values such as <NUM> degree, <NUM> degrees, <NUM> degrees, and/or other values both larger and smaller. The electrical wires <NUM> may be attached at the angle α to allow the electrical wires <NUM> to fold when the proximal end <NUM> is sneaked through the catheter shaft <NUM>. The electrical wires <NUM> are configured to move from a first position when placed in the shaft <NUM> to a second position when extending out of the shaft <NUM>. In particular, the electrical wires <NUM> may fold up in the direction of substrate <NUM> during compression (e.g., inside the shaft <NUM>), such that they are not damaged or detached from the substrate <NUM>. When the electrical wires <NUM> can fold down, away from the PCBA, when the assembly is positioned outside of the shaft <NUM>. The plurality of electrical wires <NUM> can be soldered along one or more lines extending a length of the PCBA <NUM>. For example, the plurality of electrical wires <NUM> can be soldered along a single line extending across the substrate <NUM> of the PCBA <NUM>. Each electrical wire <NUM> is soldered or adhered to a corresponding conductive portion (e.g., a contact) of the substrate <NUM> at a bond <NUM>. The electrical wire <NUM> can include a bare conductor that is soldered at the bond <NUM>, a first insulating layer <NUM>, and a second insulating layer <NUM>. The electrical wire <NUM> can be may be connected to ground on the substrate <NUM>, such as a ground strip <NUM> of the substrate <NUM>. The ground strip <NUM> can be formed of any suitable metal, such as silver, copper, gold, or aluminum. For example, the electrical wire <NUM> can be soldered or adhered to the ground strip <NUM> along the first insulating layer <NUM>. The insulating layer <NUM> and/or <NUM> may include a polymer material. In some embodiments, the substrate <NUM> includes an isolation portion <NUM> that is not populated with bonds <NUM>. This may allow room for the electrical wires <NUM> to fold up during sneaking procedures. In some embodiments, the electrical wires <NUM> are terminated on the substrate <NUM> such that the electrical wires <NUM> extend out from the substrate <NUM> at distance of <NUM> or less. In other embodiments, the electrical wires <NUM> extend out from the substrate with a distance of <NUM>, <NUM>, <NUM>, <NUM>, or other distances. In some embodiments, the PCBA <NUM> and electrical wires <NUM> terminated thereon together are configurable to form a cross-sectional area of <NUM><NUM> or less. In other embodiments, the electrical wires <NUM> extending out from the substrate <NUM> form a cross-sectional area of <NUM><NUM>, <NUM><NUM>, <NUM><NUM>, <NUM><NUM>, or less.

<FIG> shows another view of the transition portion <NUM>. The catheter cable <NUM> can include a knitted outer portion (or sheath) surrounded the plurality of electrical wires. For example, the knitted outer portion can be a radio frequency immunity (RFI) braid. In some embodiments, the RFI braid <NUM> extends from the flexible elongate body <NUM> to the substrate <NUM> of the PCBA <NUM>. The RFI braid <NUM> may include a woven material formed from one or more fibers <NUM>. The fibers <NUM> comprise a metal in some instances. The RFI braid <NUM> may provide electrical shielding for the connector <NUM> as well as strengthening the connection between the flexible elongate body <NUM> and substrate <NUM>.

As shown in <FIG>, a portion of the RFI braid <NUM> is not disposed around the electrical wires <NUM> before they are terminated on the substrate <NUM>, such that a portion of the RFI braid <NUM> runs parallel to a portion of the length of the electrical wires <NUM>. In some embodiments, the RFI braid <NUM> surrounds a portion of the electrical wires <NUM> and the electrical wires <NUM> are passed through an enlarged hole or opening <NUM> in the braid weaving of the RFI braid <NUM>. The opening <NUM> is located distal of the proximal end of the flexible elongate body <NUM>. A proximal end of the RFI braid <NUM> that does not enclose the electrical wires <NUM> may be attached to the distal end of the substrate <NUM> at bond <NUM>. The sheath or RFI braid <NUM> is terminated on the PCBA <NUM> at a position distal to the termination of the electrical wires <NUM>. The RFI braid <NUM> may be soldered, adhered, or otherwise bonded to the substrate <NUM>. For example, during a sneaking operation in assembly, the substrate <NUM> may be subjected to forces pulling the proximal end <NUM> (e.g., pulling at the opening <NUM> of <FIG>) through the catheter shaft <NUM>. These forces may be transferred to the flexible elongate body <NUM> and/or the RFI braid <NUM> at bond <NUM>, such that force is not transferred to the electrical wires <NUM> at the bonds <NUM>, thereby protecting the electrical wires <NUM> and/or their interconnection to the substrate <NUM> during assembly. In some embodiments, the RFI braid <NUM> may be configured to withstand <NUM> lbs of force applied to the proximal end <NUM>. In other embodiments, the RFI braid <NUM> may be configured to withstand <NUM>, <NUM>, <NUM>, <NUM> lbs of force, and/or other values both larger and smaller.

<FIG> shows a magnified view of a proximal portion <NUM> of the substrate <NUM> shown in <FIG>. The proximal portion <NUM> may be attached to a connector after the proximal end <NUM> is sneaked through a catheter. In some embodiments, the proximal portion <NUM> includes a low profile surface mount connector <NUM> which may include a number of miniaturized connectors <NUM> on the substrate <NUM>. The miniaturized connectors <NUM> may be attached to corresponding connectors without requiring soldering or adhesive, as shown in <FIG>. In some embodiments, the proximal portion <NUM> may include a row of pads suitable for use with a male type connector (which may also be mounted to the substrate <NUM>) and/or an elastomeric type connector. The proximal portion <NUM> may include an opening <NUM> that may be used during a sneaking operation. For example, an instrument may be passed through the opening <NUM> and used to pull the substrate <NUM> through the length of the catheter body <NUM>.

<FIG> shows the proximal portion <NUM> of the catheter cable <NUM> attached to a connector <NUM> at the proximal portion of the catheter <NUM>. The cable <NUM> may pass through an opening <NUM> at the distal portion of the connector <NUM>. The connector <NUM> includes a PCBA <NUM> including one or more electronic components. The PCBA <NUM> at the proximal portion of the cable <NUM> is electrically and mechanically coupled to the PCBA <NUM>. For example, the surface mount connector <NUM> at the proximal portion <NUM> of the PCBA <NUM> is engaged with a corresponding connector on the PCBA <NUM>. The connector <NUM> is configured to be mechanically and electrically in communication with the PIM <NUM> (<FIG>). In this manner, electrical signals can be communicated between the processing system <NUM> and the ultrasound imaging assembly <NUM> via the cable <NUM> and the PIM <NUM>.

<FIG> provides a flow diagram illustrating a method <NUM> of assembling an ultrasound imaging device, such as the ultrasound imaging device <NUM> as shown in <FIG>. As illustrated, the method <NUM> includes a number of enumerated steps, but embodiments of the method <NUM> may include additional steps before, after, and in between the enumerated steps. In some embodiments, one or more of the enumerated steps may be omitted, performed in a different order, or performed concurrently.

At step <NUM>, the method <NUM> may include attaching a distal portion of a catheter cable to an ultrasound imaging assembly. In some embodiments, the catheter cable is similar to the flexible elongate body <NUM> (<FIG>). The catheter cable may include one or more electrical wires as well as an outer layer. The electrical wire(s) of the catheter cable can be mechanically and/or electrically coupled to the ultrasound imaging assembly after attachment. The ultrasound imaging assembly can be disposed at the distal portion of the catheter cable. The attachment can be direct or indirect. For example, the cable can be directly coupled to an interposer, which is coupled to the ultrasound transducer array and/or IC. The catheter cable may be soldered, bonded, adhered, or otherwise attached to the imaging assembly.

At step <NUM>, the method <NUM> may include attaching a proximal portion of a catheter cable to PCBA(s). In some embodiments, the proximal portion of the catheter cable and the PCBA are illustrated, e.g., in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>. In some embodiments, electrical wires of the catheter cable are terminated at corresponding conductive portions of a PCBA substrate. In some embodiments, one or more portions of the PCBA can be a flexible substrate. In some embodiments, one or more portions of the PCBA can be a rigid substrate. The proximal connector may be configured to be attached to a PIM or cable that is ultimately connected to a processing system. In some embodiments, the electrical wires of the catheter cable are attached to the PCBA substrate via a foldable connection such as that shown in <FIG>. The electrical wires may be attached to the substrate at an angle. In some embodiments, the catheter cable includes an RFI braid which is mechanically connected to the substrate (e.g., soldered, bonded, adhered, and/or otherwise attached). The electrical wires may be passed through a hole in the RFI braid such that they extend between the RFI braid and the substrate. The portion of the RFI braid without the electrical wires is attached to the substrate. This structural arrangement advantageously allows the PCBA and the attached catheter cable to pulled through a catheter body (step <NUM>) during assembly without such that the substrate may be sneaked through a catheter without damaging the electrical interconnection between the wires and the PCBA. For example, the electrical wires can fold in towards the substrate to minimize the outer profile, size, and/or diameter of the proximal portion of the catheter cable. Additionally, the mechanical attachment between the RFI braid and the substrate allows for pulling forces to the transferred to the RFI braid rather than to the electrical wire interconnections. The PCBA substrate may include a low profile surface mount connector.

At step <NUM>, the method <NUM> may optionally include testing the catheter assembly including the electrical wires of the catheter cable, the ultrasound imaging assembly (e.g., the transducer array and/or IC), and the proximal PCBA. For example, the testing can ensure that electrical signals representative of commands from the console are being transmitted from the proximal PCBA to the ultrasound transducer array at the distal portion via the electrical wires. The testing can also ensure that the electrical signals representative of ultrasound imaging data are being transmitted from the ultrasound transducer array to the proximal PCBA. The testing may include checking the alignment of the electrical wires, the PCBA, and the ultrasound imaging assembly, and the quality of soldering, bonding, wirebonding, and/or overcoating of the constituent parts. The step <NUM> can be performed at any point during the assembly process and can be repeated as needed to ensure that electrical communication has not be damaged as a result of manufacturing steps. The testing of the catheter assembly may avoid waste by preventing faulty components from being paired with expensive components before detection. The ability to test the entire catheter assembly before shipping and installation may further simplify manufacturing steps.

At step <NUM>, the method <NUM> may include passing or sneaking the catheter cable through the length of the catheter shaft. In some embodiments, the proximal PCBA is also sneaked through the catheter shaft. For example, the proximal PCBA at the proximal portion of the cable can be inserted into the lumen at the distal end of the catheter shaft. An instrument can be used to connect to the proximal PCBA (e.g., at the opening <NUM> of <FIG>). The proximal PCBA and the catheter cable can be pulled, within the lumen, through the length of the catheter shaft from the distal portion of the catheter shaft to the proximal portion of the catheter shaft. In some embodiments, the cable can be passed from the proximal portion of the catheter shaft to the distal portion of the catheter shaft. Step <NUM> may include folding electrical wires of the cable towards the substrate to reduce the diameter of the proximal portion of the cable (e.g., the electrical wires connected to the PCBA). Step <NUM> can also include transferring pulling forces on the proximal PCBA to the RFI braid, rather than to the electrical wires. The method <NUM> can also include pass the catheter cable through the handle of the catheter and/or through a conduit that extends from the handle to the proximal connector.

At step <NUM>, the method <NUM> may include attaching the PCBA at the proximal portion of the catheter cable to a PCBA within the proximal connector. In some embodiments, a low profile surface mount connector of the proximal connector is attached to a corresponding connector on the PCBA within the proximal connector. In other embodiments, the PCBA at the proximal portion of the catheter cable and/or the electrical wires are soldered, adhered, and/or otherwise coupled to one or more electronic components within the proximal connector.

Claim 1:
A system (<NUM>), comprising:
an intraluminal device (<NUM>) configured to be positioned within a body lumen of a patient, the intraluminal device comprising a proximal portion (<NUM>) and a distal portion (<NUM>), , wherein the intraluminal device further comprises:
a catheter shaft (<NUM>) and a catheter cable (<NUM>) configured to be sneaked or passed through the catheter shaft during assembly;
a sensor (<NUM>) disposed at the distal portion (<NUM>);
a proximal connector (<NUM>) comprising a printed circuit board assembly (PCBA) (<NUM>), the PCBA being configured to interface with a user console and disposed at the proximal portion (<NUM>), wherein a substrate (<NUM>) of the PBCA (<NUM>) has a length (L1); and
a plurality of electrical wires (<NUM>) connecting the sensor (<NUM>) and the proximal connector (<NUM>), wherein the plurality of electrical wires (<NUM>) are attached to the substrate of the PCBA at an angle with respect to the length orientation of the substrate to allow the electrical wires (<NUM>) to fold up in the direction of the substrate during compression inside the catheter shaft, such
that the PCBA (<NUM>) and electrical wires (<NUM>) terminated thereon together are configurable to form a cross-section of <NUM><NUM> or less.