Patent Publication Number: US-2020275909-A1

Title: Connectors for patient interface module and ultrasound imaging device

Description:
RELATED APPLICATION 
     This application claims the benefit of and priority to U.S. Provisional Ser. No. 62/557,270, filed Sep. 12, 2017, which is incorporated by reference herein. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to ultrasound imaging devices. 
     BACKGROUND 
     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 (or separate 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 typically includes imaging transducers for ultrasound imaging that generates and receives acoustic energy. The imaging core may include a lined array of transducer elements or transducer elements arranged in any suitable configuration. The imaging core is encased in an imaging assembly located at a furthest distal tip of the catheter. The imaging assembly is covered with acoustic adhesive materials. An electrical cable is soldered to the imaging core and extends through the core of the body of the catheter. The electrical cable may carry control core signals and echo signals to facilitate imaging of the heart anatomy. 
     ICE catheters utilize electronics in the tip, which is manipulated inside the heart for imaging. To operate the electronics, there are signal lines that connect the electronics at the tip to an external console. To ensure the device does not pass excess leakage current from the console, through the catheter, and to the patient, electrical isolation networks are used to eliminate the risk of sending the patient into cardiac arrest. The components required for these isolation networks tend to be heavy and large in size. They also require electromagnetic interference (EMI) protection (components must be surrounded by a metal cage). The bulk and weight of these components requires large and heavy interface components used with ICE catheters. These components may be unwieldy and may ultimately require placement or mounting on the surgical bed during operation. This can be intrusive and is unappealing visually. Thus, needs exist for interface components with a reduced size and weight that do not include isolation circuitry. 
     SUMMARY 
     An ultrasound imaging system is provided by the present disclosure. The ultrasound imaging system can include a patient interface module (PIM) communicatively positioned between the intra-cardiac echocardiography (ICE) catheter and a console or control/processing system configured to receive and display imaging information from the imaging device. The PIM includes a proximal connector, a distal connector, and a cable extending between the connectors. The proximal connector of the PIM couples to the console, while the distal connector of PIM couples to a proximal connector of the ICE catheter. The PIM, PIM connectors, and the ICE catheter connector are advantageously smaller, lighter, and more easily to handle in clinical environment. 
     Technical advancements described herein include a PIM with reduced size and weight that is operable to support two- and three-dimensional imaging catheters. Furthermore, a PIM is provided that does not require a separate isolation box. For example, isolation components may be integrated directly into a PIM connector. A connector that connects the PIM and a catheter is also provided that does not require isolation components. 
     An ultrasound imaging system is provided by the present disclosure, which may include: a patient interface module communicatively positioned between an ultrasound imaging device and a console, the patient interface module comprising: a proximal connector configured to interface with the console; a distal connector configured to interface with a connector of the ultrasound imaging device; and a cable extending between the proximal connector and the distal connector, wherein the proximal connector comprises a plurality of transformers. 
     In some embodiments, the system further comprises the ultrasound imaging device. The ultrasound imaging device may include an intra-cardiac echocardiography (ICE) catheter. The ultrasound imaging device may be configured to output signals via a plurality of channels, wherein a quantity of the plurality of transformers equals a quantity of the plurality of channels. The system may further include the console, wherein the console may be configured to process the signals output by the ultrasound imaging device and display an ultrasound image based on the processed signals. 
     In some embodiments, the distal connector has a width of approximately 2 inches and a length of approximately 4.75 inches. In some embodiments, the proximal connector has a width of approximately 3 inches and a length of approximately 4.36 inches. In some embodiments, the distal connector has a weight of approximately 0.2 lbs. and the proximal connector has a weight of approximately 0.6 lbs. The distal connector may include one or more electronic components. The one or more electronic components may include a memory configured to facilitate communications between the ultrasound imaging device and the console. The one or more electronic components may include a plurality of integrated circuits configured to increase signal integrity. The one or more electronic components may include a plurality of amplifiers configured to strengthen signals output by the ultrasound imaging device. 
     An ultrasound imaging system is provided by the present disclosure, which may include: an ultrasound imaging device in communication with a console, comprising: a flexible elongate member comprising a proximal portion and a distal portion; an ultrasound transducer at the distal portion; a plurality of conductive wires extending along the flexible elongate member; and a connector at the proximal portion, wherein the connector comprises: a printed circuit board assembly (PCBA) configured to transmit imaging data obtained by the ultrasound transducer. 
     In some embodiments, the plurality of conductive wires extends from the ultrasound transducer to the connector and provides an electrical connection between the ultrasound transducer and the connector. The connector may include a first substrate at which the plurality of conductive wires terminates and a second substrate in communication with the first substrate, wherein the PCBA is disposed on the second substrate. The first substrate may be attached to a coupling module on the second substrate. 
     In some embodiments, the proximal connector has a width of approximately 3 inches and a length of approximately 4.36 inches. In some embodiments, the first substrate has a width of approximately 0.01 inch and a length of approximately 0.5 inch. Each conductive wire may serve as a data channel to transmit data from the ultrasound transducer to the connector. In some embodiments, the imaging data is stored in an EEPROM within the PCBA. 
     Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which: 
         FIG. 1  is a schematic diagram of an intraluminal imaging system according to embodiments of the present disclosure. 
         FIG. 2  is a perspective view of an imaging assembly according to embodiments of the present disclosure. 
         FIG. 3  is a top view of a tip member according to embodiments of the present disclosure. 
         FIG. 4  is a schematic diagram illustrating the beam-forming of an intraluminal imaging device according to embodiments of the present disclosure. 
         FIG. 5  is a schematic diagram illustrating aspects of an intraluminal imaging device according to embodiments of the present disclosure. 
         FIG. 6  is a flow diagram of a method of performing intraluminal imaging with an intraluminal device according to aspects of the disclosure. 
         FIG. 7  is a schematic diagram of an ultrasound imaging system according to embodiments of the present disclosure. 
         FIG. 8A  is an illustration of a patient interface module (PIM) according to embodiments of the present disclosure. 
         FIG. 8B  is a perspective view of a proximal connector of the PIM of  FIG. 8A  according to embodiments of the present disclosure. 
         FIG. 9A  is a perspective view of a connector assembly including a proximal connector of an ultrasound imaging device and a distal connector of the PIM of  FIG. 8A  according to embodiments of the present disclosure. 
         FIG. 9B  is a perspective view illustrating components of the proximal connector of the ultrasound imaging device and the distal connector of the PIM of  FIG. 9A  according to embodiments of the present disclosure. 
         FIG. 10  is a perspective view of a proximal connector of an ultrasound imaging device according to embodiments of the present disclosure. 
         FIG. 11  is a perspective view of a connector substrate according to embodiments of the present disclosure. 
         FIG. 12  is another perspective view of a connector substrate according to embodiments of the present disclosure. 
         FIG. 13  is a perspective view of a prior art PIM. 
         FIG. 14  illustrates the prior art connecter interface and a connector assembly according to embodiments of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. 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. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately. 
     To illustrate some of the advantages of the present disclosure,  FIG. 13  illustrates an existing patient interface module (PIM)  1300 . This PIM  1300  includes large and heavy electronic components such as a larger power converter  1320 , an isolation box  1310 , and a cable  1330  between the power converter and converter box. In some embodiments, the isolation box alone may weigh over 2 lbs, and the combined weight of the cable assembly may be over 3 lbs. The isolation box  1310  typically includes a number of bulky components, including an array of transformers, and a large port  1340 . For example, when the ICE transducer transmits imaging data via 64 channels, an isolation box along the cable between the ICE catheter and the signal processing system can include 64 transducers. The large port  1340  is configured to receive a large connector  1350  as shown in  FIG. 14 . Accordingly, existing connectors include large components and are not easily removable or accessible. Because the size and weight of these components, they can be difficult to maneuver in the clinical environment and take up valuable space in a procedure. 
     The embodiments of the present disclosure provide for a PIM with reduced weight and size that supports two- and three-dimensional imaging catheters. One advantage is that the PIM of the present disclosure may not require a separate isolation box (such as isolation box  1310 ) as is required by the existing PIM  1300 . Furthermore, connectors between the PIM and a catheter are not required to include isolation circuitry. Instead, isolation circuitry may be included in one or more connectors between the PIM and processing systems. 
       FIG. 1  is a schematic diagram of an intraluminal imaging system  100  according to embodiments of the present disclosure. The system  100  may include an ultrasound imaging device  110 , a connector  124 , a control and processing system  130  (for example, a console and a computer), and a monitor  132 . The ultrasound imaging device  110  includes an imaging assembly  102  at the tip of a flexible elongate member  108 , and a handle  120 . The flexible elongate member  108  includes a distal portion  104  and a proximal portion  106 . The distal end of the distal portion  104  is attached to the imaging assembly  102 . The proximal end of the proximal portion  106  is attached to the handle  120 , for example, by a resilient strain reliever  112 . The handle  120  may be used for manipulation of the ultrasound imaging device  110  and manual control of the ultrasound imaging device  110 . The imaging assembly  102  can include an imaging core with ultrasound transducer elements and associated circuitry. The handle  120  can include actuators  116 , a clutch  114 , and other steering control components for steering the ultrasound imaging device  110 . The steering may include deflecting the imaging assembly  102  and the distal portion  104 , as described in greater details herein. 
     The handle  120  is connected to the connector  124  via another strain reliever  118  and a connection cable  122 . The connector  124  may be configured to provide suitable configurations for interconnecting the control and processing system  130  and the monitor  132  to the imaging assembly  102 . The control and processing system  130  may be used for processing, storing, analyzing, and manipulating data, and the monitor  132  may be used for displaying obtained signals generated by the imaging assembly  102 . The control and processing system  130  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  130  can be operable to facilitate the features of the intraluminal imaging system  100  described herein. For example, a processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium. The monitor  132  can 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 flexible elongate member  108  into a vessel within a heart anatomy. By controlling the actuators  116  and the clutch  114  on the handle  120 , the physician or clinician can steer the flexible elongate member  108  to a position near the area of interest to be imaged. For example, one actuator  116  may deflect the imaging assembly  102  and the distal portion  104  in a left-right plane and the other actuator  116  may deflect the imaging assembly  102  and the distal portion  104  in an anterior-posterior plane, as discussed in greater details herein. The clutch  114  provides a locking mechanism to lock the positions of the actuators  116  and in effect lock the deflection of the flexible elongate member while imaging the area of interest. 
     The imaging process may include activating the ultrasound transducer elements on the imaging assembly  102  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 connector  124  transfers the received echo signals to the control and processing system  130  where the ultrasound image is reconstructed and displayed on the monitor  132 . In some embodiments, the processing system  130  can control the activation of the ultrasound transducer elements and the reception of the echo signals. In some embodiments, the control and processing system  130  and the monitor  132  may be part of a same system. 
     The system  100  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  100  is described in the context of intraluminal imaging procedures, the system  100  is suitable for use with any catheterization procedure, e.g., ICE. In addition, the imaging assembly  102  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 embodiment, the ultrasound imaging device  110  includes a flexible elongate member  108  that can be positioned within a vessel. The flexible elongate member  108  may have a distal portion  104  and a proximal portion  106 . The ultrasound imaging device  110  includes an imaging assembly  102  that is mounted within the distal portion  104  of the flexible elongate member  108 . 
     In some embodiments, the intraluminal imaging system  100  is used for generating two-dimensional and three-dimensional images. In some examples, the intraluminal imaging system  100  is used for generating X-plane images at two different viewing directions perpendicular to each other. 
       FIG. 2  is a perspective view of the imaging assembly  102  described above with respect to  FIG. 1 . The imaging assembly  102  may include the imaging core  262  that is positioned within a tip member  200 . The imaging core  262  is coupled to an electrical cable  266  via an electrical interconnection  264 . The electrical cable  266  extends through the alignment portion  244  and the interface portion  246  of the inner cavity  250 . The electrical cable  266  can further extend through the flexible elongate member  108  as shown in  FIG. 1 . 
     The configuration and structure of the tip member  200  described above provide several benefits. The benefits include providing safe and easy delivery of the catheter, providing improved tensile strength for steering and navigation, providing consistent alignment, and providing improved image quality. For example, the outer geometry of the tip member  200  is configured to provide smooth surfaces and smooth edges with small radii. The smooth edges reduce friction when the tip member  200  traverses a vessel during insertion. The smooth surfaces prevent tears and/or damages to tissue structures during the insertion. In addition, the smooth edges and smooth surfaces can facilitate crossing of a septum or other anatomical feature during a catheterization procedure. In some embodiments, the material type and the wall thickness of the tip member  200  are selected to minimize acoustic distortion, attenuation, and/or reflection. The internal geometry of the tip member  200  is configured to facilitate alignment during manufacturing. The tip member  200  can also include other features, for example, a guidewire lumen, one or more holes, or other geometry to accommodate additional devices or features such as pressure sensors, drug delivery mechanisms, and/or any suitable interventional features. 
       FIG. 3  is a top view of the imaging assembly  102  according to embodiments of the present disclosure. The imaging assembly  102  may include the imaging core  262  having an array of imaging elements  302  and micro-beam-former IC  304  that can be coupled to the array of imaging elements  302 . The imaging assembly  102  also shows the electrical cable  266  coupled to the electrical interconnection  264 . In some examples, the electrical cable  266  is further coupled through an interposer  310  to the micro-beam-former IC  304 . In some examples the interposer  310  is connected to the micro-beam-former IC  304  through wire bonding  320 . 
     In some embodiments, the array of imaging elements  302  is an array of ultrasound imaging transducers that are directly flip-chip mounted to the micro-beam-former IC  304 . The transmitters and receivers of the ultrasound imaging transducers are on the micro-beam-former IC  304  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  304 . 
     In some examples, the imaging assembly  102  includes an array of imaging elements  302  in the form of an array of more than 800 imaging elements and the electrical cable  266  includes a total of 12 signal lines or less. In some examples, the electrical cable  266  includes a total of 30 lines or less that includes the signal lines, power lines, and control lines. In some examples, an array of imaging elements, for example a one-dimensional or two-dimensional array, may include between 32 to 1000 imaging elements. For example, the array can include 32, 64, 128, 256, 512, 640, 768, or any other suitable number of imaging elements. For example, a one-dimensional array may have 32 imaging elements. A two-dimensional array may have 32, 64, or more imaging elements. In some examples, the number of signal lines are between 10 and 20, for example, 12 signal lines, 16 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 embodiments, the imaging assembly  102  includes an ultrasound transducer array with fewer than 30 wires connecting to the processing system  130 . In certain embodiments, the 30 wires or less include 6-12 signal lines, preferably include 8 signal lines. In some examples, the transducer array is capable of two-dimensional and three-dimensional imaging. Additional aspects of the intraluminal imaging system includes a micro-beam-forming IC  304  with enough signal processing power to reduce the number of required ultrasound signal lines to a fraction of the total wires that include power and control lines. 
     In some examples, the electrical cable  266  of the imaging assembly  102  is directly coupled to the micro-beam-former IC  304  of the imaging assembly  102 . 
     In some embodiments, the micro-beam-forming IC  304  lies directly underneath the array of acoustic elements  302  and is electrically connected to them. The array acoustic elements  302  may be piezoelectric or micromachined ultrasonic transducer (MUT) elements. In some examples, piezoelectric elements are attached to the IC  304  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  304 . In some examples, the cable bundle may be terminated directly to the micro-beam-forming IC  304 , or may be terminated to an interposer  310  of suitable material such as a rigid or flexible printed circuit assembly. The interposer  310  may then be connected to the micro-beam-forming IC  304  via any suitable means such as wire bondings  320 . 
       FIG. 4  is a schematic diagram  400  illustrating the beam-forming of an intraluminal imaging device according to embodiments of the present disclosure. The diagram  400  includes the imaging assembly  102  that includes the array of imaging elements  302  and micro-beam-former IC  304 . The micro-beam-former IC  304  can be coupled to the array of imaging elements  302  at the distal portion of an ultrasound intraluminal imaging device (e.g., ultrasound imaging device  110 ). As shown, the array of imaging elements  302  is divided into one or more subarrays of imaging elements  420 . For example, the array of imaging elements  302  are divided into 9 subarrays of imaging elements  420  that each has 16 imaging elements arranged as 4 by 4. The imaging assembly  102  also has the micro-beam-former IC  304  that includes a plurality of microchannels  430  that each can separately beam-form the signals received from imaging elements  420 . As shown in  FIG. 4 , for example, the microchannels  430  each comprise a delay for alignment of the signals received from the imaging elements  420  of a subarray. As shown the microchannels delay lines  430  of each subarray of imaging elements  420  are separately coupled to one coaxial cable  410  such that the received signals of each subarray of imaging elements  420  are transferred through a separate channel, e.g., coaxial cable  410 , to the control and processing system  130 . 
     In some embodiments, the imaging assembly  102  includes an array of imaging elements  302 . The array of imaging elements  302  can include two or more subarrays of imaging elements  420  of imaging elements. The imaging assembly  102  includes a micro-beam-former integrated circuit (IC)  304  coupled to the array of imaging elements. 
     In some examples, the micro-beam-former integrated circuit (IC)  304  can control the array of imaging elements  302  and can perform beam forming for a plurality of imaging elements of each subarrays of imaging elements  420  of the array of imaging elements  302 . 
     In some embodiments, the imaging assembly  102  includes a cable  266  that includes two or more signal lines that are coupled to the micro-beam-former IC  304 . Each of signal lines is associated with one of the subarrays of imaging elements  420  of the array of imaging elements  302  to transfer beam formed imaging signals of the associated subarray. For example, each signal line corresponds to an imaging element  420  and is configured to receive the beam-formed signals specific to the corresponding subarray. 
     In some embodiments, the electrical cable  266  further includes one or more power lines for feeding power to the micro-beam-former IC  304  and one or more control lines for communicating control signals to the micro-beam-former IC  304 . 
     In some examples, imaging assembly  102  includes an array of imaging elements  302  in the form of an array of more than 800 imaging elements such that the array of imaging elements is divided into no more than 12 subarrays of imaging elements  420  and the cable  410  includes no more than 12 signal lines, each signal line associated with one subarray of imaging elements  420 . 
     In some embodiments, the array of imaging elements  302  is a two dimensional array. In some examples, the array of imaging elements  302  is symmetric such that it has equal number of rows of imaging elements and columns of imaging elements. In some other examples, the array of imaging elements  302  is asymmetric such that it has different number of rows of imaging elements and columns of imaging elements. 
     In some embodiments, the micro-beam-former IC  304  includes multiple microchannel delay lines  430 . The microchannel delay lines  430  are used to perform the beam forming for the plurality of imaging elements of each of the two or more subarrays of imaging elements  420 . In some examples, the multiple microchannel delay lines  430  include at least one of a charge coupled device, an analog random access memory, or a tapped analog delay line. 
     In some examples, the first beam-formed signals and the second beam-formed signals are transmitted via a connection cable to a control and processing system  130  of  FIGS. 1 and 4 . 
       FIG. 5  is a schematic diagram illustrating aspects of an intraluminal imaging device according to embodiments of the present disclosure. The diagram  500  is consistent with the imaging assembly  102  of  FIGS. 1-4  that includes the array of imaging elements  302  and micro-beam-former IC  304 . As shown, the array of imaging elements  302  is divided into subarrays of imaging elements  420 . For example, the array of imaging elements  302  is divided into eight subarrays of imaging elements  420 . The diagram  500  also shows the cable  530  which is consistent with the cables  410  and  266  in  FIGS. 3 and 4  and includes 8 signal lines  505 , two control lines  510  and 2 power lines  520 . As shown there are 8 subarrays of imaging elements  420  and one signal line for each subarray of imaging elements  420  such that each signal line is associated with on subarray of imaging elements  420  such that the received signals of each subarray of imaging elements  420  are transferred through a separate signal lines  505  that can be consistent with the coaxial cable  410  of  FIG. 4  to the control and processing system  130 . As shown the power lines  520 /control lines  510  can be coupled to one or more subarray of imaging elements  420  and can provide power/control one or more subarray of imaging elements  420 . 
     In some embodiments, as shown in  FIGS. 4 and 5 , the overall aperture is divided into subarrays of imaging elements  420  each of which is independently beam-formed. A two-dimensional array of imaging elements  302  is shown which can also be used for three-dimensional imaging. The essential element in the micro-beam-former IC  304  is the delay in each microchannel  430 . The delay is used to time-align the echoes received by each element in the subarray of imaging elements  420  so that the signals add constructively in the desired beam direction, but destructively in other directions. The delay may be of any convenient sort of controlled variable delay, such as charge coupled devices (CCD&#39;s), analog RAM, tapped analog delay lines, etc. The amount of delay τ required depends on the size of the subarray of imaging elements  420  and the maximum steering angle θ: 
       τ= d  sin θ/ v  
 
     where d is the maximum dimension of the subarray and θ is the maximum beam steering angle, and v is the speed of sound in the object that is being imaged. In some examples, the area of a subarray of imaging elements  420  is proportional to the square of its dimension, so the maximum subarray area A is proportional to the square of the available delay: 
     
       
      
       A∝τ 
       2  
      
     
     The larger the area of each individual subarrays of imaging elements  420 , the fewer of them are needed to cover the entire acoustic aperture, the entire array of imaging elements  302 . In some examples, each subarray of imaging elements  420  feeds one signal line through a single wire, thus, the number N of ultrasound signal wires required in the cable is inversely proportional to the square of the available delay: 
         N ∝1/τ 2  
 
     In some embodiments, the delay elements in use consist of a number of repeated elements, and the number of these elements determines the maximum available delay. Since the acoustic array is flip-chip mounted to the micro-beam-former IC  304 , all of the processing, including the delay, for any given element can reside in the area occupied by that one element. In some examples, an ultrasound imaging catheter two-dimensional array may have 1000 or more elements, so the number of ultrasound signal wires required would be in the range of 30 to 50, and 15 to 20 power and control lines might also be needed. This number of wires is typical in existing one-dimensional ultrasound imaging catheters that use unshielded single wires rather than coaxial, and are individually attached to the acoustic elements. In some examples, the use of single wires rather than coax degrades the image due to noise susceptibility and crosstalk between the unshielded wires. In some examples, when using an IC within the catheter tip, the connections typically can be made to one narrow end of 2.5 mm, and so are limited to about 30 at most, including all of the ultrasonic signal lines, power lines, and control lines. 
     In some embodiments, newer IC processing equipment is now available which can approximately double the available amount of delay for the imaging signals, e.g., transducer signals. By the relations given above then the number of ultrasound signal wires could be reduced by about a factor of 4, to e.g., between 8 and 12. The total number of wires required is then in the range of 20 to 30, which is in the range of what that can be connected to the micro-beam-former IC  304 , and allows the use of coaxial cables. In some examples, the reduced wire count has a number of advantages that include: having fewer interconnects in the flexible elongate member  108  tip, e.g., the catheter tip, decreases manufacturing cost and increases yield, and larger subarrays can track the depth of the received focal point in time. 
     In some examples, a possibly digital second beam-forming stage can be used that would further reduce the channel count. In some examples, cable count can further be reduced by implementing on-chip power regulation, sharing functions of wires, and using programmable autonomous IC controllers to reduce the number of power lines and control lines. 
       FIG. 6  provides a flow diagram illustrating a method  600  of intraluminal imaging of a vessel. As illustrated, the method  600  includes a number of enumerated steps, but embodiments of the method  600  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. The method  600  can be performed with reference to  FIGS. 1, 2, 3, and 4 . At step  602 , ultrasound signals are received at an array of imaging elements, e.g., the array of imaging elements  302 . The array of imaging elements  302  can be positioned within the distal portion  104  of an ultrasound imaging device  110 . In some examples, a micro-beam-former IC  304  is directly coupled to the array of imaging elements  302  and transmits and receives imaging signals, e.g., ultrasound signals. 
     At step  604  of the method  600  the ultrasound signals received by the first subarray of the array of imaging elements  302  are beam-formed. The beam-forming can be performed with reference to  FIGS. 3 and 4 . In some embodiments, the micro-beam-former IC  304  is coupled, e.g., from beneath, to the array of imaging elements  302 . The micro-beam-former IC  304  can command the array of imaging elements  302  and can transmit and receive signals, e.g., ultrasound signals. In some examples, the array of imaging elements  302  are divided into a plurality of subarrays of imaging elements  420  including the first subarray. The micro-beam-former IC  304  can also include a plurality microchannels delay lines  430 . The micro-beam-former IC  304  can supply the required delays for beam-forming from one of the microchannels delay lines  430  to the first subarray to provide beam-forming for the first subarray such that the beam-forming is provided by applying the required delays to the signals of each of the plurality of the imaging elements of the first subarray. In some examples, the beam-forming is performed during both transmitting and receiving. In some other examples, the beam-forming is performed during the receiving. In some examples, the ultrasound signals received by the plurality of imaging elements of the first subarray of the array of imaging elements are beam-formed by applying the required delays to construct a first beam-formed signal. 
     At step  606  of the method  600  the ultrasound signals received by the second subarray of the array of imaging elements  302  are beam-formed. The beam-forming can be performed with reference to  FIGS. 3 and 4 . The micro-beam-former IC  304  can supply the required delays for beam-forming from one of the microchannels delay lines  430  to the second subarray to provide beam-forming for the second subarray such that the beam-forming is provided by applying the required delays to the signals of each of the plurality of the imaging elements of the second subarray. In some examples, the ultrasound signals received by the plurality of imaging elements of the second subarray of the array of imaging elements are beam-formed by applying the required delays to construct a second beam-formed signal. 
     At step  608  of the method  600 , the first beam-formed signal is transmitted over a first signal line of a cable of the intraluminal imaging device. This step can be performed with reference to  FIG. 4 . The beam-formed signal is constructed by applying the required beam-forming delays provided by a microchannels delay line  430  of the micro-beam-former IC  304  to the received signals of the first subarray of imaging elements  420  and then transmitting a collection of the received and delayed signals of the first subarray of imaging elements  420  through the cable, e.g., coaxial cable  410  to the control and processing system  130 . 
     At step  610  of the method  600 , the second beam-formed signal is transmitted over a second signal line of a cable of the intraluminal imaging device. Likewise, this step can be performed with reference to  FIG. 4 . The beam-formed signal is constructed by applying the required beam-forming delays provided by a microchannels delay line  430  of the micro-beam-former IC  304  to the received signals of the second subarray of imaging elements  420  and then transmitting a collection of the received and delayed signals of the imaging elements  420  through a cable, e.g., a coaxial cable to the control and processing system  130 . In some examples, the control and processing system  130  receives a plurality of the beam-formed signals from a plurality of the subarrays and constructs two-dimensional and three-dimensional images. 
     In some embodiments, the largest number of connections to a typical micro-beam-former IC  304  are the analog channel lines which carry the micro-beam-formed received signals back to the imaging system, and possibly transmit signals from the system  100  to the micro-beam-former IC. In some embodiments, large micro-beam-forming delays are produced on micro-beam-former IC  304  to reduce the number of analog channel lines compared to the existing micro-beam-former technology, thereby reducing the number of connections to the micro-beam-former IC  304  and the number of wires required to connect the imaging assembly  102  to the control and processing system  130 . The reduced wire count has a number of advantages that include: reduced materials and assembly cost, reducing manufacturing cost and increasing yield, use of coaxial cables for transferring the signals and thus decreasing susceptibility to noise and crosstalk between channels that can degrade the image, ability to use larger wire size due to smaller number of wires and thus increasing reliability, providing three-dimensional imaging capability, simplifying interconnect from the cable to the micro-beam-forming IC, and providing the potential for automating the interconnect processes. 
     ICE transducers may use a phased array sensor comprising many small individual transducers, each with a separate wire connecting the catheter to the imaging console. Up to 128 wires may be needed, leading to high cost, difficult manufacturing, and compromised image quality. In phased array ICE transducers large number of wires can be brought up the catheter from the ICE transducer to the imaging system. A typical ICE transducer might have 128 transducers and 128 wires individually coupled to the transducers. These wires can all fit inside a catheter with a typical outer diameter of about 3 mm. The requirement to have so many wires in such a small diameter effectively precludes the use of coaxial cables for the wires as used in larger ultrasound imaging transducers. Without coaxial cables there is more crosstalk between signal channels and more interference from external noise sources, both of which will degrade the ultrasound image. Additionally, the wires can be individually connected to the elements of the transducer in a compact configuration to fit within the catheter tip. This difficult interconnect operation raises the cost of the transducer and is prone to errors and damage. Once assembled, the fine wires are prone to breaking due to flexure in normal use, decreasing the overall reliability of the transducer. 
     Another problem with the current art ICE transducers is that most of them create only two-dimensional images while clinicians would like to have the possibility of three-dimensional images. The only three-dimensional ICE transducer currently available has only a small field of view and compromised image quality. Micro-beam-forming is a technology that is used in larger ultrasound imaging transducers (e.g., Philips xMatrix, Clearvue, and Lumify transducer lines) both to create three-dimensional images and to reduce the number of wires required. 
     The demand for higher quality intraluminal images for ICE procedures requires the development of miniaturized imaging elements and catheter components. One of the challenges is to create an imaging assembly configured to fit into a catheter that is also capable of high-throughput processes, such as micro-beam-forming. 
     The present disclosure may offer solutions to these problems by providing an ultrasound assembly that includes an integrated circuit (IC) with a small number of channels. Particularly, the integrated circuit is configured to perform beam-forming processes, but is designed so that the number of wires required is less than for typical micro-beam-formed transducers. The reduction in wire count enables three-dimensional imaging, use of coaxial cable, higher manufacturing yield, reduced materials cost, and simpler, more easily manufactured electrical interconnect. 
     In some embodiments, the micro-beam-forming connections to the ultrasonic elements are simplified, e.g. by flip-chip mounting of the elements directly to the IC. This is advantageous for two-dimensional imaging transducers and nearly essential for three-dimensional imaging. Also, the number of wires required is reduced. Signal processing gains, especially for three-dimensional imaging come from having the micro-beam-former&#39;s transmitters and receivers directly attached to the transducer elements rather than at the end of a long cable. However, the IC requires digital control lines, electrical power, and a number of discrete capacitors for noise decoupling and energy storage for those power supplies. This creates a new interconnect problem to connect all of the signal wires, capacitors, and power supply lines to the IC. In larger micro-beam-formed transducers a combination of flexible and rigid printed circuits is typically used to connect to I/O pads along one or more edges of the IC. In an ICE transducer, the entire assembly may fit inside of the catheter tip which typically has a diameter of only 3 mm compared to the 2-5 cm diameter of the larger transducers. Additionally, due to the small diameter of the catheter, it is desirable to have the short dimension of the acoustic aperture fill the diameter as much as possible, so it is not desirable to use any of that dimensions (the long sides of the IC) for interconnect. This limits the interconnect to be at the ends of the IC which are short, typically no more than 2.5 mm. Additionally, it may be impossible to use both ends of the IC due to difficulties of routing the wires to both ends simultaneously. The limitation of using only one edge of less than 2.5 mm severely limits the number of connections that can be made. Due to size restrictions inside the catheter, probably only one row of I/O pads could be connected along that edge, so a maximum of about 30 connections could be made with modern bonding equipment. Practical considerations related to processing the catheter can force even a smaller number. 
     Embodiments of the present disclosure, such as the beam-forming applications of the present disclosure, may include features similar to those described in U.S. Provisional App. No. 62/403,479, filed Oct. 3, 2016, U.S. Provisional App. No. 62/434,517, filed Dec. 15, 2016, U.S. Provisional App. No. 62/403,311, filed Oct. 3, 2016, U.S. Provisional App. No. 62/437,778, filed Dec. 22, 2016, U.S. Provisional App. No. 62/401,464, filed Oct. 29, 2016, U.S. Provisional App. No. 62/401,686, filed Oct. 29, 2016, and/or U.S. Provisional App. No. 62/401,525, filed Oct. 29, 2017, the entireties of which are hereby incorporated by reference herein. 
       FIG. 7  is a schematic diagram of an ultrasound imaging system  100  according to embodiments of the present disclosure. One or more components of the system  100  of  FIG. 7  can include features similar to those shown and described with respect to  FIGS. 1-6 . The system  100  may include the ultrasound imaging device  110 , the control and processing system  130 , and a patient interface module (PIM)  131  extending between the device  110  and the processing system  130 . For example, the PIM  131  may provide a physical and electrical connection between the ultrasound imaging device  110  and the control and processing system  130 . Some embodiments of the present disclosure omit the PIM  131 . In other embodiments, the PIM  131  is communicatively interposed between the ultrasound imaging device  110  and the processing system  130 . In some instances, the PIM  131  can be referenced as a patient interface cable. For example, a proximal connector of the ultrasound imaging device  110 , a distal connector of the PIM, and/or a proximal connector of the PIM may be configured to couple the ultrasound imaging device  110 , the PIM  131 , and the control and processing system together mechanically and electrically. The system  100  may include may include a connector assembly  1000  comprising a connector of the ultrasound imaging device  110  and the PIM  131  that is discussed in more detail in reference to  FIGS. 9A and 9B . 
     In some embodiments, the control and processing system  130  may include one or more computers, processors, and/or computer systems. The control and processing system  130  may also be referred to as a console. In some embodiments, the PIM  131  is in mechanical and electrical communication with the control and processing system  130 , such that the electrical signals are transmitted the ultrasound imaging device  110  through the PIM  131  and to the control and processing system  130 . The control and processing system  130  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  132 . One or more electrical conductors of the ultrasound imaging device  110  and PIM  131  may facilitate communication between the control and processing system  130  and the ultrasound imaging device  110 . For example, a user of the control and processing system  130  may control imaging using the ultrasound imaging device  110  via a control interface  134  of the control and processing system  130 . Electrical signals representative of commands from the control and processing system  130  may be transmitted to the ultrasound imaging device  110  via connectors and/or cables in the PIM  131  and the ultrasound imaging device  110 . The control and processing system  130  may be transportable and may include wheels or other devices to facilitate easy transportation by a user. 
     In some embodiments, the PIM  131  includes a distal connector  730  and a proximal connector  750  (as shown in, e.g.,  FIG. 8A ) that are removably connectable to the ultrasound imaging device  110  and control and processing system  130 , respectively. In particular, the ultrasound imaging device  110  and PIM  131  may be connected at a connector assembly  1000  which is discussed in more detail in reference to  FIGS. 9A and 9B . In some embodiments, the one or more components of the ultrasound imaging device  110  may be disposable components. For example, a user, such as a physician, may obtain the ultrasound imaging device  110  in a sterilized packaging. In some embodiments, the ultrasound imaging device  110  may be disposed after a single use. In other embodiments, the ultrasound imaging device  110  can be sterilized and/or re-processed for more than one use. The PIM  131  may be a re-usable component that is used in multiple procedures. For example, the PIM  131  can be cleaned between individual procedures, such as being treated with disinfectants to kill bacteria. In some embodiments, the PIM  131  may not be required to be sterilized before a medical procedure. For example, the PIM  131  can be sufficiently spaced from the patient such that use of a non-sterile PIM  131  is safe for the patient. The sterile-nonsterile connection at the connector assembly  1000  between the ultrasound imaging device  110  and the PIM  131  may allow for a safe operating environment while saving costs by allowing expensing equipment to be reused. 
     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  110  and the system  100  generally can 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  110  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  110  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&#39;s vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or any suitable lumen inside the body. 
       FIG. 8A  is an illustration of the patient interface module (PIM)  131 , according to aspects of the present disclosure. The PIM  131  includes a proximal connector  750 , a distal connector  730 , and a cable  740  extending between the proximal connector  750  and the distal connector  730 . The distal connector  730  is configured to be mechanically and/or electrically coupled to the imaging device  110 . The proximal connector  750  is configured to be mechanically and/or electrically couple to the control and processing system  130 . For example, the proximal connector  750  is configured to be inserted into one a slot  136  on the control and processing system  130  ( FIG. 7 ). The proximal connector  750  and the slots  136  may include any suitable connections that are configured to mechanically and/or electrically couple to one another. In some embodiments, the conduit or cable  740  can be referenced as a flexible elongate member. The cable  740  includes one or more electrical conductors to facilitate electrical communication between the proximal connector  750  and the distal connector  730 . As a result, the PIM  131  facilitates electrical communication between the ultrasound imaging device  110  and the processing system  130 . 
       FIG. 8B  is a perspective view of the proximal connector  750  of the PIM  131 , according to embodiments of the present disclosure. The proximal connector  750  can include one more electronic component to facilitate communication with the processing system  130 . For example, the proximal connector  750  includes a connector module  920 . The connector module  920  may be disposed on a side surface of the proximal connector  750 . In some embodiments, the connector module  920  can include one or more male or female zero insertion force (ZIF) connectors. In such embodiments, the slots  136  of the processing system  130  may include corresponding female or male ZIF connectors. As such, when the proximal connector  750  of the PIM  131  is inserted into the one or more slots  136  ( FIG. 7 ), the male/female connectors in the PIM  131  are electrically connected to the female/male connectors in the slots  136 . Generally, the connector module  920  can be any suitable type of male or female electrical connector. For example, electrical connectors can include one or more types of connectors, such as low insertion force (LIF) connectors, flat flexible connectors (FFC), ribbon cable connectors, and serial advanced technology attachment (SATA) connectors. 
     In some embodiments, the proximal connector  750  includes a number of electrical transformers  930 . These transformers  930  facilitate electrical isolation of the high voltage signals associated with the imaging assembly  102  of the ultrasound imaging device  110 . In that regard, the patient safety is facilitated by providing electrical isolation. At the same time, a minimal number of transformers  930  can provide such safety while being positioned in the relatively smaller and less heavy body of the proximal connector  750 . In some embodiments, the number of transformers  930  in the proximal connector  750  is equal to the number of data channels output by the ultrasound imaging device  110 . For example, there may be 8 data channels and 8 transformers  930  in the proximal connector  750 . In other embodiments, there may be 10 data channels and transformers, 6 data channels and transformers, or other suitable numbers of channels and transformers. 
     Advantageously, the PIM  131  is configured with features to avoid the bulky components of existing systems (as described, e.g., with respect  FIGS. 13 and 14 ). For example, the ultrasound imaging device  110  may include one or more Application Specific Integrated Circuits (ASICs) which may be configured to provide signal generation (whereas existing systems generated signals at the console and transmitted the signal to the imaging device). The ASICs may also provide beam-forming such that the number of distinct channels or communication lines along the cable  740  is reduced. For example, the ASICs of the ultrasound imaging system  100  may sum about 850 channels and reduce this number to about 8 channels. Prior art systems needed a PIM with completely separate isolation box to house large number of isolation transformers, e.g., sixty-four transformers because of the larger number of channel/communication lines. The ultrasound imaging device  110  allows for the proximal connector  750  of the PIM  131  to include, e.g., eight transformers in a relatively small and low-weight package. 
       FIGS. 9A and 9B  are perspective views of a connector assembly  1000  including a proximal connector  124  of the ultrasound imaging device  110  and the distal connector  730  of the PIM  131 , according to embodiments of the present disclosure.  FIG. 9B  illustrates exemplary interior and exterior components of the connector assembly  1000 . The proximal connector  124  and the distal connector  730  can be connected to establish mechanical and/or electrical communication between the ultrasound imaging device  110  and the PIM  131 . In the illustrated embodiment, the distal connector  730  includes a male type connector module  1020  while the connector  124  includes a female type connector module  1022 . In other embodiments, the connector  124  includes a male type connector and the connector  730  includes a female type connector. 
     Referring to  FIGS. 8A, 8B, 9A, and 9B , generally, the connectors of the PIM  131  (e.g., the proximal connector  750  and the distal connector  730 ) and the proximal connector  124  of the ultrasound imaging device  110  may include any suitable connections that are configured to mechanically and/or electrically couple to other connections or devices. In some embodiments, the connectors  124 ,  730 , and  750  may also be configured to be water resistant or waterproof, such as being designed for an IPX4 rating, as well as other ratings. 
     One or more of the connectors  124 ,  730 , and  750  can include various electronic components to facilitate transmission of signals between the ultrasound imaging device  110  and the control and processing system  130 . In some embodiments, the distal connector  730 , the proximal connector  750 , and the connector  124  are configured to include one or more PCB boards. These PCB boards may include one or more electronic components, including memory, buffers, amplifiers, other integrated circuits, and other components. For example, the distal connector  730  and the proximal connector  750  may include one or more memories to store data, for example, a cache memory (e.g., a cache memory of the processor), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), a solid state memory device, or other forms of volatile and non-volatile memory. In some embodiments, one or more of the distal connector  730  and the proximal connector  750  include an EEPROM that allows the ultrasound imaging device  110  to be able to interact in real time with the control and processing system  130 . For example, a memory device of the proximal connector  124  of the imaging device  110  can store identifying information about the imaging assembly  102 , such as the frequency of the ultrasound transducers, the date of manufacture, the date of first/last use, the number of permissible uses, etc. The identifying information can be queried by the processing system  130 , and the system  130  can control operation of the ultrasound imaging device  110  based on the identifying information, including allowing operation of the imaging assembly  102 , processing the ultrasound imaging data obtained by the imaging assembly  102 , etc. 
     The connectors  124 ,  730 , and/or  750  may also include one or more integrated circuits configured to increase the stability and/or integrity of signals transmitted from the ultrasound imaging device. These integrated circuits may include one or more buffers, including an array of buffers. The connectors  124 ,  730 , and/or  750  may also include one or more amplifiers to strengthen signals transmitted from the ultrasound imaging device to provide for better image quality. In some embodiments, the connectors  124 ,  730 , and/or  750  are long and very small in diameter, which may cause a loss in signal amplitude when signals traverse the connectors  124 ,  730 , and/or  750 . An amplifier integrated circuit may be inserted into each connector  124 ,  730 , and/or  750  to restore the amplitude of signals. For digital signals passing through the connectors  730 ,  124  to the imaging assembly  102 , signal amplitude levels may be restored with digital buffer amplifiers inserted into each digital line in the PIM  131 . Furthermore, the connectors  124 ,  730 , and/or  750  may include PCBs for other design parameters. For example, conductive wires extending from the imaging assembly  102  of the ultrasound imaging device  110  may terminate directly onto a PCB within proximal connector  124 . 
     In some embodiments, the connector assembly  1000  includes a connector  124  of the ultrasound imaging device  110  that is configured to connect to a distal connector  730  of the PIM  131 . The connectors  124 ,  730  may include one or more PCB boards  1010 ,  1012  with electronic components, as well as connector modules  1020 ,  1022 . The PCB boards  1010 ,  1012  may include one or more substrates (such as substrate  1016 ), flexible PCB boards, connectors, cables, and other components. The connector modules  1020 ,  1022  may include a number of pins or other electrical connections that are operable to provide electrical connections between the connectors  124 ,  730 . The PCB boards  1010 ,  1012  within the connectors  124 ,  730  may be electrically connected through the connector modules  1020 ,  1022  such that data may be transmitted through the connector assembly  1000  when the connector modules  1020 ,  1022  are in contact. 
     In some embodiments, connector  124  may include a first PCB board  1010  as well as a substrate  1016  configured to serve as a termination point for a number of wires  1014  extending through the ultrasound imaging device  110 . In some embodiments, the wires  1014  may be similar to the electrical cables  266  discussed in reference to  FIG. 3 , and may extend from an imaging device through the ultrasound imaging device  110 . In some embodiments, the substrate  1016  is attached to the PCB board  1010  at a port  1018 , as further shown in  FIG. 10 . The wires  1014  may be routed through the ultrasound imaging device, such as bundled together or through one or more twists or loops, such as the loop shown in  FIG. 9B . The shape and size of the wires  1014  may allow the ultrasound imaging device to be articulable while allowing for the transfer of large amounts of imaging data. The connectors  124 ,  730  may also include cables  1030 ,  1040  extending out from the connectors  124 ,  730 . The cables  1030 ,  1040  may serve as anchor points for the PCB boards  1010 ,  1012  as well as providing stability for electrical wires or connections extending through the ultrasound imaging device  110  and the PIM  131 . 
     With reference to  FIGS. 8B, 9A, and 9B , the proximal connector  750  of the PIM  131 , the distal connector  730  of the PIM  131 , and the proximal connector  124  of the imaging device  110  advantageously have a relatively smaller profile and relatively lighter weight than prior art devices. Accordingly, a user in a clinical environment is advantageously able to connect the ultrasound imaging device  110 , PIM  131 , and/or processing system  130  using connectors  124 ,  730 , and  750  that are easier to handle because they are smaller and lighter than prior art devices. In some embodiments, the proximal connector  750  of the PIM  131  weighs approximately 275 grams or 0.6 lbs. In other embodiments, the proximal connector  750  of the PIM  131  weighs approximately 0.8 lbs, between 0.5 lbs and 0.6 lbs, between 0.7 and 0.9 lbs, between 0.75 lbs and 1 lb, or between 0.5 and 1.2 lbs. A connector module  1020  may be included on a distal end of the distal connector  730 . In some embodiments, the connector module  1020  is smaller than the connector module  920 . In some embodiments, the distal connector  730  of the PIM  131  weighs approximately 95 grams or 0.2 lbs, between 0.1 and 0.3 lbs, between 0.15 lbs and 0.25 lbs, or between 0.05 and 0.3 lbs. In some embodiments, the combined weight of the PIM  131  is approximately 460 grams or 1 lb. In other embodiments, the combined weight of the PIM  131  is less than 1 lb, about 1 lb, between 0.8 and 1.2 lbs, or between 0.75 and 1.25 lbs. 
     In some embodiments, the proximal connector  750  has a length L 1  of approximately 4.36 inches, a width W 1  of approximately 3 inches, and a height H 1  of approximately 1.1 inches. In other embodiments, length L 1  may be between 4 and 4.5 inches, between 3 and 5 inches, or between 4.3 and 4.4 inches, as well as other lengths. The width W 1  may be between 2 and 4 inches, between 1 and 5 inches, or between 2.5 and 3.5 inches, as well as other widths. The height H 1  may be between 1 and 2 inches, between 0.5 and 1.5 inches, or between 1.1 and 1.2 inches, as well as other heights. 
     In some embodiments, the distal connector  730  has a length L 2  of approximately 4.75 inches, a width W 2  of approximately 2 inches, and a height H 2  of approximately 1 inch. In other embodiments, length L 2  may be between 4.5 and 5 inches, between 4.6 and 4.9 inches, or between 4.7 and 4.8 inches, as well as other lengths. The width W 2  may be between 1.9 and 2.1 inches, between 1.75 and 2.25 inches, or between 1.9 and 2.1 inches, as well as other widths. The height H 2  may be between 0.75 and 1.25 inches, between 0.95 and 1.05 inches, or between 0.9 and 1.1 inches, as well as other heights. 
     In some embodiments, the connector  124  has a length L 3  of approximately 4 inches, a width W 3  of approximately 2 inches, and a height H 3  of approximately 1 inch. In other embodiments, length L 3  may be between 3.9 and 4.1 inches, between 3.75 and 4.25 inches, or between 3.95 and 4.05 inches, as well as other lengths. The width W 3  may be between 1.75 and 2.25 inches, between 1.9 and 2.1 inches, or between 1.95 and 2.05 inches, as well as other widths. The height H 3  may be between 0.75 and 1.25 inches, between 0.95 and 1.05 inches, or between 0.9 and 1.1 inches, as well as other heights. 
       FIG. 10  is an overhead perspective view of a connector  124  of the ultrasound imaging device  110 , showing the PCB board  1010 , connector module  1022 , and strain relief or cable inlet  1040 . The PCB board  1010  may include a number of electrical components, including integrated circuits and vias. The PCB board  1010  may include one or more ports  1118  that may provide a connection to other substrates, such as substrate  1016  shown in  FIGS. 9, 11, and 12 . The PCB board  1010  may include one or more memory modules, amplifiers, buffers, or other integrated circuits. 
       FIG. 11  is a perspective view of the substrate  1016  and wires  1014 . The wires  1014  may be bundled into a cable  1032  as shown in the example of  FIG. 11 . Furthermore, the substrate  1016  may include a connector portion  1034  including a number of electrical connectors  1036 . These electrical connectors  1036  may connect to other connectors within the port  1018  as shown in  FIGS. 9 and 10 . The substrate  1016  may serve as a termination point for the wires  1014  and may include converters (such as analog-to-digital or digital-to-analog converters) to transfer the data from the wires  1014  to other electrical components, including various integrated circuits. In some embodiments, the substrate  1016  ( FIGS. 11 and 12 ) may be a flexible substrate, while the PCB  1010  ( FIG. 10 ) and/or other PCBs are rigid substrates. 
       FIG. 12  is a comparison  1200  of an exemplary substrate  1016  and a dime  1210  to show the approximate size of the substrate  1016 . In some embodiments, the substrate  1016  may have a length L 4  of approximately 1.2 inches. The length L 4  may be between 1 and 1.25 inches, between 0.5 and 1.5 inches, or between 1.2 and 1.3 inches, as well as other lengths. The substrate  1016  may have a width W 4  of approximately 0.08 inches. The width W 4  may be between 0.05 and 0.10 inches, between 0.075 and 0.085 inches, or between 0.07 and 0.09 inches, as well as other widths. The small size of the substrate  1016  and fine wires  1014  may provide for a smaller PCB board within the connector  124  of the ultrasound imaging device  110 . 
     As described above,  FIG. 13  illustrates a prior art patient interface module (PIM) that is large, heavy, and can be cumbersome to use. For example, as illustrated in  FIG. 14 , the large connector  1350  of an imaging device is connected to the isolation box  1310 . In contrast, embodiments, of the present disclosure provide a PIM  131 , and connectors  124 ,  730 , and/or  750  that are smaller, lighter, and easier to use. For example, the PIM  131  does not require a distinct isolation box  1310  because electrical isolation transformers can be provided in proximal connector  750  of the PIM  131 . Because the transformers are disposed in the proximal connector  750  of the PIM  131 , the connector assembly  1000  between the PIM  131  and the ultrasound imaging device  110  (including the connectors  124  and  730 ) can provide a much smaller footprint by including smaller PCB boards and significant weight savings (i.e., two or more lbs.). As shown in the comparison of  FIG. 14 , the connector assembly  1000  provides a much smaller cross section, weighs less, and is more easily transported in a medical environment. This may also allow for easier storage of the connector. For example, the PIM  131  may be stored within the processing system  130 , such as in a bay beneath the slots  136 . The reduced size and weight of the connector assembly may also allow the addition of accessories to the connector assembly  1000  that would not be possible with the existing obtrusive and heavy PIM shown in  FIG. 13 . For example, bed rail hooks, EPIQ holders, bedside interfaces, and other accessories may be added to the PIM. Furthermore, the connector assembly  1000  may provide substantial cost and time savings by including a disposable portion (connector  124 ) and a non-disposable portion (distal connector  730 ). Additionally, PIM  131  may provide improved flexibility of design over existing PIMs. For example, by incorporating PCBAs inside each connector of the connector assembly  1000 , a designer may be able to redesign the circuitry, add/remove current electrical designs/components, and/or adapt connectors to other devices so long as the required electrical changes can fit on the defined board. In this way, the same connectors can be used across various situations or projects by only changing the internal PCBA in the connectors. Thus, the connectors within the connector assembly are more adaptable than existing connectors. 
     Persons skilled in the art will recognize that the apparatus, systems, and methods described above can be modified in various ways. Accordingly, persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.