Digital rotary patient interface module

Abstract

Systems, devices, and methods for intraluminal ultrasound imaging are provided. An intraluminal ultrasound imaging system may include a patient interface module (PIM) in communication with an intraluminal device that includes an ultrasound imaging component and is positioned within a body lumen of a patient. The PIM may receive an ultrasound echo signal from the intraluminal device, transmit the ultrasound echo signal along a differential signal path, and digitize the ultrasound echo signal. The PIM may transmit the ultrasound echo signal to a processing system over an Ethernet connection.

Description

Technical Field

[0001] The present disclosure generally relates to intravascular imaging and, more particularly, to receiving and converting imaging signals using a patient interface module (PIM). The PIM may be configured to send ultrasonic echo signals along a differential signal path. The PIM may also be configured to support Ethernet communication. Background Art

[0002] Intravascular ultrasound (IVUS) imaging is widely used as a diagnostic tool in interventional cardiac imaging to evaluate diseased blood vessels (e.g., arteries) within the human body to determine the need for treatment, guide interventions, and / or evaluate their effectiveness. An IVUS device including one or more ultrasonic transducers is delivered into the blood vessel and guided to the area to be imaged. The transducer emits ultrasonic energy having a frequency higher than 2 MHz to create an image of the blood vessel of interest. The ultrasonic waves are partially reflected by discontinuities caused by tissue structures (e.g., the various layers of the blood vessel wall), red blood cells, and other features of interest. The echoes from the reflected waves are received by the transducer and transmitted to the IVUS imaging system. The imaging system processes the received ultrasonic echoes to generate a cross-sectional image of the blood vessel in which the device is placed.

[0003] The IVUS catheter may include a rotating device. For a typical rotating IVUS catheter, the ultrasonic transducer element is located at the tip of a flexible drive shaft that rotates inside a plastic sheath inserted into the blood vessel of interest. The transducer element is oriented such that the ultrasonic beam propagates into the tissue and returns. The transducer then monitors the returning echoes reflected from various tissue structures. The returning echoes are generally sent along a single analog channel to the IVUS processing system. These transmissions may be susceptible to electrical noise and electromagnetic coupling interference associated with the transmission that degrades the IVUS image quality. In addition, existing IVUS systems typically require expensive and complex custom cables to send signals between the ultrasonic transducer element and the processing system. Accordingly, there is a need for improvements to IVUS imaging systems. Summary of the Invention

[0004] Systems, devices, and methods for intravascular ultrasound imaging are provided. An intravascular ultrasound imaging system may include a patient interface module (PIM) in communication with an intravascular device positioned within a body lumen of a patient. The PIM may receive ultrasonic echo signals, send the ultrasonic echo signals along a differential signal path, and digitize the ultrasonic echo signals. The ultrasonic echo signals may also be configured to be sent via an Ethernet connection to a processing system connected to the PIM.

[0005] Embodiments of the present disclosure provide an intravascular ultrasound imaging system, which may include: a patient interface module (PIM) communicatively disposed between a processing system and an intravascular ultrasound device configured to be positioned within a body lumen of a patient, the PIM including a transmitter, an analog-to-digital converter (ADC), and a communication device including a communication cable, wherein the PIM is configured to: transmit a first signal to the intravascular ultrasound device using the transmitter; receive an ultrasound echo signal associated with the first signal from the intravascular ultrasound device; digitize the ultrasound echo signal using the ADC; convert the digitized ultrasound echo signal into a second signal capable of being conveyed via the communication device; and transmit the second signal to the processing system via the communication cable of the communication device.

[0006] In some embodiments, the processing system is configured to generate an intravascular ultrasound image representing the ultrasound echo signal based on the second signal and display the intravascular ultrasound image on a display device communicatively coupled to the processing system. The communication cable may be an Ethernet cable or a USB cable. The PIM may further include a controller communicatively coupled to the transmitter, the ADC, and the communication device. The controller may be a field-programmable gate array (FPGA).

[0007] In some embodiments, the intravascular ultrasound device includes: a rotatable flexible elongate drive cable including a proximal portion and a distal portion; and an ultrasound element disposed at the distal portion of the drive cable and configured to acquire imaging data of the body lumen while rotating. The intravascular ultrasound device may be an intravascular ultrasound (IVUS) device configured to be positioned within a blood vessel. The ultrasound echo signal may travel on a differential signal path to the ADC within the PIM. In some embodiments, the differential signal path includes one or more amplifiers and bandpass filters.

[0008] Also provided is a method of intravascular ultrasound imaging, which may include: transmitting a first signal using an intravascular ultrasound device positioned within a body lumen of a patient; receiving an ultrasound echo signal associated with the first signal from the intravascular ultrasound device using a patient interface module (PIM) communicatively disposed between the intravascular ultrasound device and a processing system; digitizing the ultrasound echo signal using the ADC in the PIM; converting the digitized ultrasound echo signal into a second signal capable of being conveyed via a communication device using a controller in the PIM; and transmitting the second signal to the processing system via the communication device.

[0009] The method may further include displaying, using a display device communicatively coupled to the processing system, an intravascular ultrasound image representative of the ultrasound echo signals. The method may include formatting, by the PIM, the ultrasound echo signals according to an image display format of the display device. The communication device may be an Ethernet cable or a USB cable. The controller may be a field programmable gate array (FPGA).

[0010] In some embodiments, the method further includes converting, using an Ethernet physical layer (PHY) device, the digitized ultrasound echo signals into a second signal. The method may include sending the ultrasound echo signals along a differential signal path to the ADC within the PIM. The intravascular ultrasound device may include: a rotatable flexible elongate drive cable including a proximal portion and a distal portion; and an ultrasound element disposed at the distal portion of the drive cable and configured to acquire imaging data of the body lumen while rotating. The intravascular ultrasound device may be an intravascular ultrasound (IVUS) device configured to be positioned within a blood vessel.

[0011] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, in which:[[]]END]]

[0013] Figure 1 is a diagrammatic schematic view of an intravascular ultrasound imaging system in accordance with some embodiments of the present disclosure.

[0014] Figure 2 is a diagrammatic schematic view of an intravascular ultrasound imaging system in accordance with some embodiments of the present disclosure.

[0015] Figure 3 is a diagrammatic schematic view of a rotational ultrasound device in accordance with some embodiments of the present disclosure.

[0016] Figure 4 is a diagrammatic view of a rotational ultrasound device in situ within a patient's anatomy in accordance with some embodiments of the present disclosure.

[0017] Figure 5 is a diagrammatic perspective view of a patient interface module (PIM) in accordance with some embodiments of the present disclosure.

[0018] Figure 6 is a flow chart of an ultrasound imaging method in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION

[0019] For purposes of promoting an understanding of the principles of the present disclosure, reference is now made to the embodiments illustrated in the drawings and specific language will be used to describe them. However, it is to be understood that no limitation of the scope of the present disclosure is thereby intended. As would be readily appreciated by one of ordinary skill in the art to which the present disclosure pertains, any changes and further modifications to the described devices, systems and methods, and any further applications of the principles of the present disclosure are fully anticipated and included within the present disclosure. For example, it is fully anticipated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, numerous iterations of these combinations will not be described separately.

[0020] Figure 1 FIG. 4 is a schematic diagrammatic illustration of an ultrasound system 100 in accordance with some embodiments of the present disclosure. The ultrasound system 100 can be used to perform intravascular ultrasound imaging of a lumen of a patient. The system 100 can include an ultrasound device 110, a patient interface module (PIM) 150, an ultrasound processing system 160, and / or a monitor 170. The ultrasound device 110 is structurally arranged (e.g., sized and / or shaped) to be positioned within the anatomy 102 of a patient. The ultrasound device 110 obtains ultrasound imaging data from within the anatomy 102. The ultrasound processing system 160 is capable of controlling the acquisition of ultrasound imaging and can be used to generate an image of the anatomy 102 that is displayed on the monitor 170 (using the ultrasound imaging data received via the PIM 150).

[0021] In some embodiments, system 100 and / or PIM 150 can include features similar to those described in U.S. Patent Application No. US62 / 574655, titled "WIRELESS DIGITAL PATIENT INTERFACE MODULE USING WIRELESS CHARGING," filed on October 19, 2017; U.S. Patent Application No. US62 / 574687, titled "INTRALUMINAL DEVICE REUSE PREVENTION WITH PATIENT INTERFACE MODULE AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS," filed on October 19, 2017; U.S. Patent Application No. US62 / 574835, titled "INTRALUMINAL MEDICAL SYSTEM WITH OVERLOADED CONNECTORS," filed on October 20, 2017; and U.S. Patent Application No. US62 / 574610, titled "HANDHELD MEDICAL INTERFACE FOR INTRALUMINAL DEVICE AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS," filed on October 19, 2017, each of which is hereby incorporated by reference in its entirety.

[0022] Typically, the ultrasound device 110 can be a catheter, guiding catheter, or guide wire. The ultrasound device 110 includes a flexible elongate member 116. As used herein, an "elongate member" or "flexible elongate member" includes at least any slender flexible structure that is structurally arranged (e.g., sized and / or shaped) to be positioned within the lumen 104 of an anatomical structure 102. For example, the distal portion 114 of the flexible elongate member 116 is positioned within the lumen 104, while the proximal portion 112 of the flexible elongate member 116 is positioned outside the patient's body. The flexible elongate member 116 can include a longitudinal axis LA. In some instances, the longitudinal axis LA can be the central longitudinal axis of the flexible elongate member 116. In some embodiments, the flexible elongate member 116 can include one or more polymer / plastic layers formed from various grades of nylon, nylon elastomer, polymer compositions, polyimide, and / or polytetrafluoroethylene. In some embodiments, the flexible elongate member 116 can include one or more layers of braided metal and / or polymer strands. The (one or more) braided layers can be braided tightly or loosely in any suitable configuration (including any suitable per-in-count (pic)). In some embodiments, the flexible elongate member 116 can include one or more metal and / or polymer coils. All or part of the flexible elongate member 116 can have any suitable geometric cross-sectional profile (e.g., circular, oval, rectangular, square, elliptical, etc.) or non-geometric cross-sectional profile. For example, the flexible elongate member 116 can have a generally cylindrical profile with a circular cross-sectional profile that defines the outer diameter of the flexible elongate member 116. For example, the outer diameter of the flexible elongate member 116 can be any suitable value for positioning within the anatomical structure 102, including between about 1 Fr (0.33 mm) and about 15 Fr (5 mm), including values such as 3.5 Fr (1.16 mm), 5 Fr (1.67 mm), 7 Fr (2.33 mm), 8.2 Fr (2.73 mm), 9 Fr (3 mm), and / or other suitable larger and smaller values.

[0023] The ultrasound device 110 may or may not include one or more lumens that extend along all or a portion of the length of the flexible elongate member 116. The lumens of the ultrasound device 110 may be structurally arranged (e.g., sized and / or shaped) to receive and / or guide one or more other diagnostic and / or therapeutic instruments. If the ultrasound device 110 includes the lumen(s), the lumen(s) may be centered or offset relative to the cross-sectional profile of the device 110. In the illustrated embodiment, the ultrasound device 110 is a catheter and includes a lumen at the distal portion 114 of the flexible elongate member 116. A guidewire 140 extends through the ultrasound device 110 lumen between the in / out port 142 and the out / in port at the distal end 118 of the flexible elongate member 116. Generally, the guidewire 140 is a slender flexible structure that is structurally arranged (e.g., sized and / or shaped) to be disposed within the lumen 104 of the anatomical structure 102. During a diagnostic and / or therapeutic procedure, a medical professional typically first inserts the guidewire 140 into the lumen 104 of the anatomical structure 102 and moves the guidewire 140 to a desired location within the anatomical structure 102, e.g., adjacent to an obstruction 106. The guidewire 140 facilitates the introduction and positioning of one or more other diagnostic and / or therapeutic instruments (including the ultrasound device 110) at a desired location within the anatomical structure 102. For example, the ultrasound device 110 is moved along the guidewire 140 through the lumen 104 of the anatomical structure 102. In some embodiments, the lumen of the ultrasound device 110 may extend along the entire length of the flexible elongate member 116. In the illustrated embodiment, the out / in port 142 is positioned proximal to the component 30 of the ultrasound device 110. In some embodiments, the out / in port 142, the out / in port at the distal end 118, and / or the lumen of the ultrasound device 110 are positioned distal to the component 30. In some embodiments, the ultrasound device 110 is not used with a guidewire, and the out / in port 142 may be omitted from the ultrasound device 110.

[0024] The anatomical structure 102 can represent any fluid-filled or surrounding structure, natural or artificial. For example, the anatomical structure 102 can be within a patient's body. Fluid can flow through the lumen 104 of the anatomical structure 102. In some instances, the ultrasound device 110 can be referred to as an intraluminal device. The anatomical structure 102 can be a vasculature (e.g., a blood vessel), where blood flows through the lumen 104. In some instances, the ultrasound device 110 can be referred to as an intravascular device. In various embodiments, the blood vessel is an artery or vein of the patient's vascular system, including the cardiac vasculature, the peripheral vasculature, the neurovascular system, the renal vasculature, and / or any other suitable anatomical structure / lumen within the body. In some instances, the anatomical structure 102 can be tortuous. For example, the device 110 can be used to examine any number of anatomical locations and tissue types, including but not limited to: organs including the liver, heart, kidney, gallbladder, pancreas, lungs, esophagus; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and valves within the blood, chambers or other parts of the heart, and / or other systems of the body. In addition to natural structures, the device 110 can be used to examine artificial structures such as but not limited to heart valves, stents, shunts, filters, and other devices.

[0025] An occlusion 106 of the anatomical structure 102 generally represents any blockage or other structural arrangement that results in a restriction of the flow of fluid through the lumen 104, for example, in a manner that is detrimental to the health of the patient. For example, the occlusion 106 narrows the lumen 104 such that the cross-sectional area of the lumen 104 and / or the available space for fluid to flow through the lumen 104 is reduced. In the case where the anatomical structure 102 is a blood vessel, the occlusion 106 can be the result of plaque accumulation, including but not limited to plaque components such as, for example, fibrous, fibro-lipid (fibro-fatty), necrotic core, calcification (dense calcium), blood, fresh thrombus, and / or mature thrombus. In some instances, the occlusion 106 can be referred to as a thrombus, stenosis, and / or lesion. Generally, the composition of the occlusion 106 will depend on the type of anatomical structure being evaluated. A healthier portion of the anatomical structure 102 can have a uniform or symmetric profile (e.g., a cylindrical profile with a circular cross-sectional profile). The occlusion 106 can not have a uniform or symmetric profile. Thus, the reduced portion of the anatomical structure 102 with the occlusion 106 will have an asymmetric and / or other irregular profile. Although the anatomical structure 102 is Figure 1 illustrated as a single occlusion 106, it should be understood that the devices, systems, and methods described herein have similar applications for anatomical structures with multiple occlusions.

[0026] The ultrasonic device 110 may include an ultrasonic imaging component 130 disposed at the distal portion 114 of the flexible elongate member 116. The ultrasonic imaging component 130 may be configured to emit ultrasonic energy into the anatomical structure 102 while the device 110 is positioned within the lumen 104. In some embodiments, the component 130 may include various numbers and configurations. For example, some of the components 130 may be configured to transmit ultrasonic pulses, while other components may be configured to receive ultrasonic echoes. The component 130 may be configured to emit ultrasonic energy of different frequencies into the anatomical structure 102 depending on the type of tissue being imaged and the type of imaging being used.

[0027] In some embodiments, the component 130 includes one or more ultrasonic transducers. For example, the component 130 may be configured to generate and emit ultrasonic energy into the anatomical structure 102 in response to being activated by an electrical signal. In some embodiments, the component 130 includes a single ultrasonic transducer. In some embodiments, the component 130 includes an ultrasonic transducer array, including more than one ultrasonic transducer. For example, the ultrasonic transducer array may include any suitable number of individual transducers between 2 transducers and 1000 transducers, including, for example, 2 transducers, 4 transducers, 36 transducers, 64 transducers, 128 transducers, 500 transducers, 812 transducers, and / or other values, larger and smaller. The ultrasonic transducer array including the component 130 may be any suitable configuration, for example, a phased array, including a planar array, a curved array, a circumferential array, an annular array, etc. For example, in some instances, the ultrasonic transducer array including the component 130 may be a one-dimensional array or a two-dimensional array.

[0028] In some instances, the ultrasonic imaging component 130 may be part of a rotational ultrasonic device. The active area of the ultrasonic imaging component 130 may include one or more segments (e.g., one or more rows, one or more columns, and / or one or more orientations) of one or more transducer materials and / or ultrasonic elements that may be uniformly and / or independently controlled and activated. The active area of the component 130 may be patterned or structured in various basic or complex geometries. The component 130 may be disposed in a side-view orientation (e.g., ultrasonic energy emitted perpendicular and / or orthogonal to the longitudinal axis LA) and / or a forward-view observation orientation (e.g., ultrasonic energy emitted parallel to and / or along the longitudinal axis LA). In some instances, the component 130 is structurally arranged to emit and / or receive ultrasonic energy at an angle of inclination with respect to the longitudinal axis LA in the proximal or distal direction. In some embodiments, the ultrasonic energy emission may be electronically steered by selective triggering of the ultrasonic imaging component 130 in the array.

[0029] The ultrasonic transducer(s) of component 130 can be piezoelectric micromachined ultrasonic transducers (PMUTs), capacitive micromachined ultrasonic transducers (CMUTs), single crystals, lead zirconate titanate (PZT), PZT composites, other suitable transducer types, and / or combinations thereof. Depending on the transducer material, the manufacturing process for the ultrasonic transducer(s) can include cutting, grooving, grinding, sputtering, wafer technology (e.g., SMA, sacrificial layer deposition), other suitable processes, and / or combinations thereof.

[0030] In some embodiments, component 130 is configured to obtain ultrasonic imaging data associated with anatomical structure 102 (e.g., obstruction 106). The ultrasonic imaging data obtained by ultrasonic imaging component 130 can be used by medical professionals to diagnose a patient, including evaluating obstruction 106 of anatomical structure 102. For imaging, component 130 can be configured to emit ultrasonic energy into lumen 104 and / or anatomical structure 102, and receive ultrasonic echoes representing reflections from the fluid and / or tissue of lumen 104 and / or anatomical structure 102. As described herein, component 130 can include ultrasonic imaging elements, e.g., ultrasonic transducers and / or ultrasonic transducer arrays. For example, component 130 generates ultrasonic energy and emits the ultrasonic energy into anatomical structure 102 in response to sending an electrical signal to component 130. For imaging, component 130 can generate and send an electrical signal (e.g., sent to PIM 150 and / or processing system 160) representing the received reflections from anatomical structure 102. In various embodiments, ultrasonic imaging component 130 can obtain imaging data associated with intravascular ultrasound (IVUS) imaging, forward-looking intravascular ultrasound (FL-IVUS) imaging, intravascular photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and / or other suitable imaging modalities. In some embodiments, device 110 can include imaging components for any suitable imaging modality (e.g., optical imaging, optical coherence tomography (OCT), etc.). In some embodiments, device 110 can include any suitable sensing components, including pressure sensors, flow sensors, temperature sensors, optical fibers, reflectors, mirrors, prisms, ablation elements, radio frequency (RF) electrodes, conductors, and / or combinations thereof. The imaging and / or sensing components can be implemented in device 110 instead of or in addition to ultrasonic component 130.

[0031] For diagnosis and / or imaging, the center frequency of component 130 can be between 2 MHz and 75 MHz, for example, including values such as 2 MHz, 5 MHz, 10 MHz, 20 MHz, 40 MHz, 45 MHz, 60 MHz, 70 MHz, 75 MHz, and / or other suitable values greater and smaller. For example, lower frequencies (e.g., between 2 MHz and 10 MHz) can advantageously penetrate further into anatomical structure 102 such that multiple in the anatomical structure 102 are visible in the ultrasound image. Higher frequencies (e.g., 50 MHz, 75 MHz) can be better suited for generating a more detailed ultrasound image of the anatomical structure 102 and / or the fluid within lumen 104. In some embodiments, the frequency of the ultrasound imaging component 130 is tunable. For imaging, in some instances, component 130 can be tuned to receive wavelengths associated with the center frequency and / or one or more harmonics of the center frequency. In some instances, the frequency of the emitted ultrasound energy can be modified by the voltage of the applied electrical signal and / or by applying a bias voltage to the ultrasound imaging component 130.

[0032] In some embodiments, the ultrasound imaging component 130 is positioned at the distal portion of the flexible elongate member 116. The ultrasound imaging component 130 can include one or more electrical conductors extending along the length from the flexible elongate member 116. The (one or more) electrical conductors communicate with the ultrasound imaging component 130 at the distal portion 114 and the interface 156 at the proximal portion 112. The electrical conductors convey electrical signals between the ultrasound processing system 160 and the ultrasound imaging component 130. For example, activation and / or control signals can be sent from the processing system 160 to the ultrasound imaging component 130 via the electrical conductors. Electrical signals representing reflected ultrasound echoes can be sent from the ultrasound imaging component 130 to the processing system 160 via the electrical conductors. In some embodiments, the same electrical conductors can be used for communication between the processing system 160 and the ultrasound imaging component 130.

[0033] The ultrasound device 110 includes an interface 156 at the proximal portion 112 of the flexible elongate member 116. In some embodiments, the interface 156 may include a handle. For example, the handle may include one or more actuation mechanisms for controlling the movement of the device 100 (e.g., deflection of the distal portion 114). In some embodiments, the interface 156 may include a retractable mechanism that allows the device 110 to be pulled back through the lumen. In some embodiments, the interface 156 may include a rotational mechanism that rotates one or more components of the device 110 (e.g., the flexible elongate member 116 and the ultrasound imaging component 130). In some embodiments, the interface 156 includes user interface components (e.g., one or more buttons, switches, etc.) for a medical professional to selectively activate the ultrasound imaging component 130. In other embodiments, the user interface components of the PIM 150, the processing system 160, and / or the monitor 170 allow the medical professional to selectively activate the ultrasound imaging component 130. A conduit (including, for example, electrical conductors) extends between the interface 156 and the connector 108. The connector 108 may be configured to mechanically and / or electrically couple the device 110 to the PIM 150.

[0034] The ultrasound processing system 160, the PIM 150, and / or the intravascular ultrasound device 110 (e.g., the interface 156, the ultrasound imaging component 130, etc.) may include one or more controllers. In some embodiments, the controller may be an integrated circuit, e.g., an application specific integrated circuit (ASIC). The controller may be configured to select the specific transducer element(s) to be used for transmitting and / or receiving, provide a transmit trigger signal to activate the transmitter circuit to generate electrical pulses to excite the selected transducer element(s), and / or receive the amplified echo signals received from the selected transducer element(s) via an amplifier of the controller. Multiple ASIC configurations with various numbers of master and slave circuits may be used to create a single ultrasound or multi-transmit ultrasound device.

[0035] In some embodiments, the PIM 150 performs preliminary processing of the ultrasound echo data before relaying the data to the console or the processing system 160. In an example of such an embodiment, the PIM 150 performs amplification, filtering, and / or summarization of the data. In embodiments, the PIM 150 also supplies high and low voltage DC power to support the operation of the device 110 including circuits associated with the ultrasound transducer 130. The PIM 150 may be an isolated device because patient safety requirements enforce physical and electrical isolation of the patient from one or more high voltage components in various surgical settings.

[0036] The ultrasound processing system 160 receives imaging data (e.g., an electrical signal representing ultrasound echo data) from the ultrasound imaging component 130 via the PIM 150. The processing system 160 may include processing circuitry, e.g., a processor and / or a memory. The processing system 160 processes the data to reconstruct an image of the anatomical structure. The processing system 160 outputs image data such that an image of the anatomical structure 102 (e.g., a cross-sectional IVUS image of a blood vessel) is displayed on the monitor 170. The processing system 160 and / or the monitor 170 may include one or more user interface elements (e.g., a touch screen, a keyboard, a mouse, virtual buttons on a graphical user interface, physical buttons, etc.) to allow a medical professional to control the device 110, including one or more parameters of the ultrasound imaging component 130.

[0037] Figure 2 is a schematic diagrammatic illustration of an ultrasound system 100 in accordance with an embodiment of the present disclosure. Figure 3 is a schematic diagrammatic partial cross-sectional perspective view of an ultrasound device 110 in accordance with an embodiment of the present disclosure. Figure 4 is a schematic view of the ultrasound device 110 in situ within the anatomical structure 102.

[0038] Specifically referring to Figure 2 In some embodiments of the present disclosure, the ultrasound system 100 is a rotational IVUS imaging and therapeutic ultrasound system. The rotational ultrasound system 100 can include an ultrasound device 110, a console or processing system 160, and a monitor 170. As discussed in more detail herein, the ultrasound device 110 includes an ultrasound transducer 130 for imaging. The ultrasound device 110 can also include circuitry associated with the ultrasound transducer 130 mounted near the distal tip of a catheter, an electrical cable having one, two, three, four, or more conductors, and appropriate connectors that support mechanical and / or electrical interconnections at a rotational interface at the proximal portion 112. The body of the ultrasound device 110 can be referred to as a flexible elongate member 116. The distal portion 114 of the ultrasound device 110 is positioned within the patient's anatomical structure 102. The proximal portion 112 of the ultrasound device 110 is mechanically and / or electrically coupled to the mobile device 180 of the system 100. The mobile device includes one or more motors, associated circuitry, and / or other suitable components structurally arranged to apply rotational and / or longitudinal movement to one or more components of the ultrasound device 110 (e.g., the drive cable 211). In some instances, the mobile device 180 can be referred to as a pullback device and / or a sled.

[0039] In some embodiments, the mobile device 180 and the PIM 150 can be combined in a single device. In other embodiments, the system 100 includes a PIM 150 that is different from the mobile device 180. The PIM 150 generates a sequence of required transmit trigger signals and controls the waveforms to regulate the operation of the circuits associated with the ultrasound imaging component 130 and processes the amplified echo signals received through the conductors of the cable. The PIM 150 also supplies DC high and low voltages to support the operation of the ultrasound imaging component 130. In this regard, the PIM 150 is structurally arranged to supply DC voltage across the rotary interface to the circuits of the ultrasound device 110 using a slip ring and / or an implementation of the active rotary transformer technology described in U.S. Patent US8403856, which is hereby incorporated by reference in its entirety. In some embodiments, the PIM 150 supplies AC voltage to the ultrasound imaging component 130 using, for example, a resolver.

[0040] Figure 3 and Figure 4 Illustrates additional details regarding the structure of the rotary ultrasound device 110. Figure 4 The ultrasound device 110 in situ within the anatomical structure 102 is also shown. In some aspects, the ultrasound device 110 is similar to a rotary IVUS catheter, such as those available from Volcano Corporation and described in U.S. Patent US8104479 catheters, or those described in U.S. Patents US5243988 and US5546948, each of the above patents being hereby incorporated by reference in its entirety. In this regard, the ultrasound device 110 includes an imaging core 210 and an outer catheter / sheath assembly 212. The imaging core 210 includes a flexible drive cable or shaft terminated at the proximal end of the proximal portion 112 by a rotary interface 214 that provides a mechanical and electrical coupling to the PIM 150. The imaging core 210 can also include one, two, three, four, five or more electrical conductors that communicate with the ultrasound imaging component 130. The distal portion 114 of the flexible drive shaft of the imaging core 210 is mechanically coupled to the proximal portion of a transducer housing 216 that contains the ultrasound imaging component 130 and associated circuits, as described in more detail herein.

[0041] The catheter / sheath assembly 212 includes a hub 218 that supports a rotary interface 214 and provides a bearing surface and fluid seal between the rotating and non-rotating elements of the ultrasound device 110. The hub 218 includes a Luer lock flush port 220 through which saline is injected to flush air out of the sheath 212 and fill the inner lumen of the sheath 212 with an ultrasound-compatible fluid when using the ultrasound device 110. Flushing with saline or other similar fluids is typically required because air does not readily conduct ultrasound. The saline also provides biocompatible lubrication for the rotary drive cable of the imaging core 210. The hub 218 is coupled to a telescope 222 that includes nested tubular elements and sliding fluid seals that allow the catheter / sheath assembly 212 to be lengthened or shortened to facilitate axial or longitudinal movement of the transducer housing within the acoustically transparent window 224 in the distal portion of the ultrasound device 110. In some embodiments, the window 224 is formed of a thin-walled plastic tube made of a material(s) that readily conducts ultrasonic waves with minimal attenuation, reflection, or refraction between the transducer and the vascular tissue. The proximal shaft 226 of the catheter / sheath assembly 212 bridges the segment between the telescope 222 and the window 224 and is formed of a material and / or composite material that provides a lubricated internal lumen and optimal stiffness but does not conduct ultrasound. In the illustrated embodiment, a guide wire in / out port 142 is provided at the distal portion of the ultrasound device 110.

[0042] The mobile device 180 rotates the drive cable 211 of the imaging core 210 (e.g., in a clockwise or counterclockwise direction 230) that is inserted inside a polymer / plastic sheath 212 that is inserted into the lumen 104 of the anatomical structure 102. Rotation of the drive cable 211 causes a corresponding rotation of the housing 216, which is mechanically coupled to the drive cable. The ultrasound imaging component 130 is fixedly secured to the housing 216 and rotates correspondingly with the drive cable 211. The ultrasound imaging component 130 is oriented such that the respective ultrasonic beam 124 propagates generally perpendicular to the longitudinal axis LA of the ultrasound device 110. The fluid-filled sheath 212 protects the tissue of the anatomical structure from the rotating ultrasound imaging component 130 and drive cable 211 while allowing the ultrasound signals to propagate freely. When the drive shaft rotates (e.g., at 30 revolutions per second), the ultrasound imaging component 130 is selectively and / or periodically excited with high voltage pulses to emit a burst of ultrasonic energy. The ultrasound imaging component 130 monitors the return ultrasound echoes 126 reflected from various tissue structures (e.g., obstruction 106) of the anatomical structure 102. Based on the IVUS imaging data obtained by the ultrasound imaging component 130, the IVUS imaging system 160 aggregates two-dimensional images of the vascular cross-section according to a series of several hundred such ultrasound pulse / echo acquisition sequences that occur during a single revolution of the ultrasound imaging component 130.

[0043] The ultrasonic imaging component 130 can be mechanically coupled to the housing 216 using any suitable attachment mechanism (e.g., adhesive, welding, brazing, etc.). The ultrasonic imaging components 130 can be positioned adjacent to each other along the longitudinal axis LA. In some instances, the ultrasonic imaging components 130 can be referred to as being aligned in series. In some embodiments, the ultrasonic imaging components 130 are positioned side by side along an axis perpendicular to the longitudinal axis LA. In some embodiments, the ultrasonic imaging components 130 are disposed on opposite sides of the housing 216. For example, in the orientation of the housing 216 illustrated in Figure 6 one of the ultrasonic imaging components 130 can be disposed on one side of the housing 216 (e.g., face up), while the other ultrasonic imaging component 130 can be disposed on the opposite side of the housing 216 (e.g., face down). For example, the ultrasonic imaging components 130 can be configured to transmit ultrasonic energy in opposite directions. In the illustrated embodiment, the ultrasonic imaging components 130 are individual ultrasonic elements. In other embodiments, the ultrasonic imaging components 130 can be a one-dimensional or two-dimensional ultrasonic array including two or more ultrasonic transducers.

[0044] Figure 5 is a schematic diagram of the PIM 150. In some embodiments, the PIM 150 is communicatively disposed between the ultrasonic device 110 and the processing system 160. The PIM 150 can be used to send commands and signals to the ultrasonic device 110, and to receive, process, and send ultrasonic echo signals from the ultrasonic device 110. In some embodiments, these ultrasonic echo signals are sent along differential signal paths in the PIM 150 and are digitized and formatted for Ethernet transmission to the ultrasonic processing system 160.

[0045] The PIM 150 can include an outer housing 304. The housing 304 can be suitable for use in a sterile environment (i.e., water resistant) and can be sized to fit on an operating table. In some embodiments, the housing 304 includes an interior section that houses various components. For example, the housing 304 can include a particular housing section that houses a power system 340, a signal chain 350, and a controller 310 and associated components.

[0046] The controller 310 of the PIM 150 can be configured to send signals to other elements of the PIM 150 as well as external devices, such as the ultrasonic device 110, the processing system 160, and the monitor 170. In some embodiments, the controller 310 is a field programmable gate array (FPGA). In other embodiments, the controller 310 is configured to execute the reference herein as above Figure 5The central processing unit (CPU), digital signal processor (DSP), application specific integrated circuit (ASIC), another hardware device, firmware device, or any combination thereof that performs the operations described by the controller 310 shown therein.

[0047] The controller 310 may be connected to a memory 318. In some embodiments, the memory is a random access memory (RAM). In other embodiments, the memory 318 is a cache memory (e.g., the cache memory of the controller 310), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid state memory device, hard disk drive, other forms of volatile and non-volatile memory, or a combination of different types of memory. In some embodiments, the memory 318 may include a non-transitory computer-readable medium. The memory 318 may store instructions. The instructions may include instructions that, when run by the processor, cause the processor to perform the operations described herein with reference to the controller 310 in connection with embodiments of the present disclosure.

[0048] The controller 310 may be connected to a catheter motor 326, EEPROM 324, transmitter 322, and time gain compensation (TGC) control 320. In some embodiments, the catheter motor 326 is configured to move the ultrasound device 110 within a lumen. The catheter motor 326 may include a rotating component for rotating a portion of the ultrasound device 110. The catheter motor 326 may also include a motor for moving the ultrasound device 110 along a lumen within a patient's body.

[0049] The transmitter 322 may be any type of transmitting device for transmitting signals to the ultrasound device 110. In some embodiments, the controller 310 is configured to control the ultrasound device 110 by transmitting signals via the transmitter 322. In this way, the controller 310 may be configured to drive the transmission of ultrasound signals through the ultrasound device 110. The direction of transmission and signal intensity of the ultrasound signals may be controlled by the controller 310. The transmitter 322 may be connected to a transmit / receive (T / R) switch 328. In some embodiments, the T / R switch 328 may be configured to change between a transmit mode and a receive mode. For example, when the T / R switch 328 is in the transmit mode, the controller 310 may transmit signals to the ultrasound device 110. Data (e.g., ultrasound echo signals) may be transmitted back from the ultrasound device 110 to the PIM 150. This data may be stored by the EEPROM 324. When the ultrasound echo signals are transmitted back from the ultrasound device 110 to the PIM 150, the T / R switch 328 may be set to the receive mode to receive the ultrasound echo signals and direct the ultrasound echo signals along the correct signal path.

[0050] The ultrasonic echo signal can be received by the PIM 150 and guided along a differential signal path. In some embodiments, the differential signal path can include a signal chain 350 that includes one or more elements 352, 354, 356, 358, 360, 362. The differential signal path can help eliminate common-mode noise and in particular the "white noise / flicker" that can occur in existing image processing systems. The differential signal path and the associated signal chain 350 can result in a more noise-free signal and improved image quality. The signal chain 350 can provide filtering and programmable gain functions. In some embodiments, the TGC control 320 is a time-varying gain that is adjusted for signal loss as the distance between the PIM 150 and the ultrasound device 110 increases. For near reflections, the gain is typically reduced, while for far reflections, it is gradually increased. The amount of gain with distance can be controlled, for example, by the controller 310 of the PIM 150. In some embodiments, the TGC control can be configured to control the signal amplification of the received ultrasonic echo signal. The TGC control 320 can also be configured to set the reception path for the ultrasonic echo signal along the signal chain 350. The signal chain 350 can include bandpass filters 352, 360 and amplifiers 354, 356, 358, 362. For example, the ultrasonic echo signal from the ultrasound device 110 can be sequentially passed through a first bandpass filter 352, a first fixed amplifier 354, a variable gain amplifier 356, a first buffer amplifier 358, a second bandpass filter 360 and a second buffer amplifier 362. In some embodiments, the bandpass filters 352, 360 allow signals between 20 and 40 MHz. In other embodiments, the bandpass filters allow other ranges of signals, such as 10 to 50 MHz, 5 to 60 MHz and other ranges.

[0051] After the signals are passed through the signal chain 350, they can be sent to the analog-to-digital converter (ADC) 330. The ADC 330 can digitize the ultrasound echo signals for processing by the controller 310. The signals can then be prepared for sending to the ultrasound processing system 160. In some embodiments, the signals from the ultrasound device 110 can be sent to the ultrasound processing system 160 via an Ethernet connection. In this case, the signals from the ultrasound device 110 (which have been digitized by the ADC 330) are sent to the Ethernet physical layer (PHY) 316. The Ethernet PHY can be configured to transform the signals from the ultrasound device 110 for the Ethernet connection. The transformed signals can then be transmitted to the isolation transformer 314. In some embodiments, the isolation transformer 314 meets the IEC-60601 requirements for Ethernet-based transformers. The signals are then transmitted to the Ethernet connection 312 for sending to the ultrasound processing system 160. The Ethernet connection 312 can include one or more Ethernet cables and associated ports.

[0052] In other embodiments, the PIM 150 can be configured to send data from the ultrasound device 110 to the ultrasound processing system 160 via a standard other than Ethernet (e.g., USB (and particularly USB3.0)). In this case, the PIM 150 can include a USB connector, and the signals from the ultrasound device 110 can be configured for use with USB.

[0053] The PIM 150 can include a pull-back motor 332 that can be used to pull the ultrasound device 110 through the lumen to collect imaging data. The pull-back motor 332 can be configured to pull the ultrasound device 110 at a constant speed. The pull-back motor 332 can be connected to an external pull-back skid 334.

[0054] The PIM 150 can include a power system 340. In some embodiments, the PIM 150 is powered by Power over Ethernet (PoE). In this case, power can be input via the Ethernet connection 312 or via another Ethernet connection on the PIM 150. In other embodiments, the PIM 150 is powered by a power input 342 within the power system 340. The power input 342 can be AC / DC power. The power input 342 can be connected to an isolation power module 344 that can convert the power to DC / DC. The power can then be distributed throughout the PIM 150 via a power distributor 346.

[0055] Figure 6A flowchart of a method 600 for intravascular ultrasound imaging is provided. As illustrated, method 600 includes a plurality of enumerated steps, but embodiments of method 600 may include additional steps before, after, and between the enumerated steps. In some embodiments, one or more of the enumerated steps may be omitted, performed in a different order, or performed simultaneously. Method 600 may be performed using any of the systems and devices mentioned in Figures 1 - 5 to execute.

[0056] At step 602, method 600 may include positioning an ultrasound device within a body lumen of a patient. The ultrasound device may be similar to the ultrasound device 110 shown in Figure 1 , Figure 4 and Figure 5 . In particular, the ultrasound device may be an intravascular rotational ultrasound device having one or more imaging ultrasound transducer elements at a distal portion of a rotatable drive cable. Step 602 may include placing a sheath and an imaging core / drive cable within the lumen of an anatomical structure. The drive cable may be disposed within the sheath of the ultrasound device.

[0057] At step 604, method 600 may include transmitting a first ultrasound signal into the lumen using the ultrasound device. The first ultrasound signal may be transmitted using one or more ultrasound elements of the ultrasound device. In some embodiments, the transmission of the first ultrasound signal may be controlled by a patient interface module (PIM) (e.g., PIM 150 as shown in Figure 1 and Figure 5 ). For example, a controller of the PIM may be used to send a signal to the ultrasound device, which in turn may be transmitted into the lumen through one or more ultrasound elements of the ultrasound device. Step 604 may be performed while the drive cable and one or more ultrasound elements of the ultrasound device are rotating within a sheath positioned inside the lumen. In this regard, method 600 may include connecting the ultrasound device and / or the drive cable to a mobile device (e.g., a pullback device) configured to rotate and / or longitudinally translate the ultrasound device. The first ultrasound signal may be reflected off anatomical structures (e.g., tissue, blood vessels, plaque, etc.) within the lumen in the form of ultrasound echoes, some of which may travel back towards the first ultrasound element. These ultrasound echo signals may be received by the ultrasound device, for example, using one or more transducer elements.

[0058] At step 606, the ultrasound echo signal associated with the first ultrasound signal may be sent to the PIM. In some embodiments, the ultrasound echo signal is received by a transmit / receive (T / R) switch (e.g., T / R switch 328 as shown in Figure 5 ). The ultrasound echo signal may be processed by the PIM in preparation for its use in generating an ultrasound image of the lumen.

[0059] At step 608, the ultrasound echo signal can be sent on a differential signal path within the PIM. In some embodiments, the differential signal path can help reduce noise. The differential signal path can include a signal chain having one or more amplifiers and buffers. In some embodiments, the differential signal path sequentially includes a first band-pass filter, a first fixed amplifier, a variable gain amplifier, a first buffer amplifier, a second band-pass filter, and a second buffer amplifier. In other embodiments, the differential signal path includes other combinations of components.

[0060] At step 610, the ultrasound echo signal can be digitized. In some embodiments, after being transmitted along the differential signal path, the ultrasound echo signal is sent to an ADC within the PIM. The ADC can be used to digitize the ultrasound echo signal. The digitized ultrasound echo signal can then be sent to a controller within the PIM.

[0061] At step 612, the digitized ultrasound echo signal can be configured for an Ethernet connection. In some embodiments, this includes using the controller of the PIM to send the digitized ultrasound echo signal to an Ethernet physical layer (PHY). Step 612 can also include transmitting the ultrasound echo signal through an isolation transformer and to an Ethernet connector.

[0062] At step 614, the digitized ultrasound signal can be sent to a processing system via an Ethernet connection. The processing system can be the processing system 160 as Figure 1 shown. Step 614 can be performed by using one or more Ethernet cables connected between the PIM and the processing system. The processing system can be used to further process the digitized ultrasound echo signal to generate an ultrasound image of a patient's lumen.

[0063] At step 616, an ultrasound image representing the ultrasound echo signal can optionally be displayed on a display device. The display device can be similar to the monitor 170 as Figure 1 shown. For example, the image can be an IVUS image of a blood vessel.

[0064] Those skilled in the art will realize that the above-described apparatus, systems, and methods can be modified in various ways. Accordingly, those of ordinary skill in the art will recognize that the embodiments covered by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, although illustrative embodiments have been shown and described, a wide range of modifications, changes, and substitutions are envisioned in the foregoing disclosure. It should be understood that such changes can be made to the foregoing without departing from the scope of this disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with this disclosure.

Claims

1. An intravascular ultrasound imaging system, comprising: A patient interface module (PIM) communicatively disposed between a processing system and an intravascular ultrasound device configured to be positioned within a body lumen of a patient, the PIM including a transmitter, an analog-to-digital converter (ADC), an isolation transformer, and a communication device including a communication cable, wherein the PIM is configured to: Transmit a first signal to the intravascular ultrasound device using the transmitter; Receive an ultrasound echo signal associated with the first signal from the intravascular ultrasound device; Digitize the ultrasound echo signal using the ADC; Convert the digitized ultrasound echo signal into a second signal capable of being conveyed via the communication device; Transfer the second signal to the isolation transformer to generate a transformed second signal; and Transmit the transformed second signal to the processing system via the communication cable of the communication device.

2. The intravascular ultrasound imaging system according to claim 1, wherein, The processing system is configured to generate an intravascular ultrasound image representing the ultrasound echo signal based on the second signal and display the intravascular ultrasound image on a display device communicative with the processing system.

3. The intravascular ultrasound imaging system according to claim 1, wherein, The communication cable is an Ethernet cable.

4. The intravascular ultrasound imaging system according to claim 1, wherein, The communication cable is a USB cable.

5. The intravascular ultrasound imaging system according to claim 1, wherein The PIM further includes a controller communicative with the transmitter, the ADC, and the communication device.

6. The intravascular ultrasound imaging system according to claim 5, wherein, The controller is a field programmable gate array (FPGA).

7. The intravascular ultrasound imaging system according to claim 1, wherein The intravascular ultrasound device includes: A rotatable flexible elongate drive cable including a proximal portion and a distal portion; and An ultrasound element disposed at the distal portion of the drive cable and configured to obtain imaging data of the body lumen while rotating.

8. The intravascular ultrasound imaging system according to claim 1, wherein, The intravascular ultrasound device is an intravascular ultrasound (IVUS) device configured to be positioned within a blood vessel.

9. The intravascular ultrasound imaging system according to claim 1, wherein, The ultrasound echo signal travels on a differential signal path to the ADC within the PIM.

10. The intravascular ultrasound imaging system according to claim 9, wherein, The differential signal path includes a bandpass filter.

11. A method of intravascular ultrasound imaging, comprising: Transmitting a first signal using an intravascular ultrasound device positioned within a body lumen of a patient; Receiving an ultrasound echo signal associated with the first signal from the intravascular ultrasound device using a patient interface module (PIM) communicatively disposed between the intravascular ultrasound device and a processing system; Digitizing the ultrasound echo signal using the ADC in the PIM; Converting the digitized ultrasound echo signal into a second signal capable of being conveyed via a communication device using a controller in the PIM; Transferring the second signal to an isolation transformer in the PIM to generate a transformed second signal; and And Transmitting the transformed second signal to the processing system via the communication device.

12. The method according to claim 11, further comprising displaying an intravascular ultrasound image representing the ultrasound echo signal using a display device communicative with the processing system.

13. The method according to claim 12, further comprising formatting the ultrasound echo signal by the PIM according to an image display format of the display device.

14. The method according to claim 11, wherein, The communication device is an Ethernet cable.

15. The method according to claim 11, wherein The communication device is a USB cable.

16. The method according to claim 11, wherein, The controller is a field programmable gate array (FPGA).

17. The method according to claim 11, further comprising converting the digitized ultrasound echo signal into a second signal using an Ethernet physical layer (PHY) device.

18. The method according to claim 11, further comprising sending the ultrasound echo signal along a differential signal path to the ADC within the PIM.

19. The method according to claim 11, wherein, The intravascular ultrasound device comprises: a rotatable flexible elongate drive cable including a proximal portion and a distal portion; and an ultrasound element disposed at the distal portion of the drive cable and configured to acquire imaging data of the body lumen while rotating.

20. The method according to claim 11, wherein, The intravascular ultrasound device is an intravascular ultrasound (IVUS) device configured to be positioned within a blood vessel.

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