Disposable intraluminal sensing device with use tracking

Abstract

An intraluminal imaging catheter includes a flexible elongate member configured to be positioned within a body lumen of a patient, an ultrasound transducer array coupled to the flexible elongate member and configured to obtain imaging data while positioned within the body lumen, and a memory including a plurality of regions configured to store one or more values of one or more fields, wherein the plurality of regions includes a first region, wherein the one or more fields in the first region include a device identification, a serial number, and / or a manufacture date, wherein the plurality of regions includes at least a second region, wherein the one or more fields in the at least second region include a current use count of the intraluminal imaging catheter, a maximum number of uses, and a status. Associated devices, systems, and methods are also disclosed.

Description

Technical Field

[0001] This disclosure generally relates to instrumented intraluminal sensing devices, and more particularly to intraluminal imaging catheters, such as intracardiac echocardiography (ICE) catheters, equipped with tracking hardware. Background Technology

[0002] Diagnostic and therapeutic ultrasound catheters have been designed for use in many areas of the human body. In the cardiovascular system, a common diagnostic ultrasound method is intraluminal ultrasound imaging, with intracardiac echocardiography (ICE) being a specific example. Typically, a single rotating transducer or an array of transducer elements is used to emit ultrasound at the distal end of the catheter. The same transducer is used to receive the echo from the tissue. The signal generated from the echo is transmitted to a control console, which allows for the processing, storage, display, or manipulation of ultrasound-related data.

[0003] Intraluminal imaging catheters, such as ICE catheters (e.g., Siemens Acunav, St. Jude ViewFlex), are commonly used to image the heart and surrounding structures, for example, to guide and facilitate medical procedures such as transseptal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair. Commercially available ICE catheters have a distal end that can be hinged via a steering mechanism in a handle located proximal to the catheter. For example, intraluminal imaging catheters such as ICE catheters can be inserted via the femoral or jugular vein to access anatomical structures and can be steered within the heart to obtain the images needed for the safety of medical procedures.

[0004] Intraluminal imaging catheters can be reusable or disposable. Technically, reusing disposable intraluminal catheters is possible, and manufacturers have little control over this process. Multiple uses can degrade catheter performance. This can adversely affect the images clinicians use to make diagnostic and / or treatment decisions, thus jeopardizing patient health. Care must also be taken to ensure appropriate sterilization and aseptic repackaging techniques are used before reuse, as patient health may also be at risk. Clinicians may not know that a catheter has been used rather than being new, or they may know that a catheter has been used before but are unaware of the number of times it was previously used or the conditions under which it was used or reused. Summary of the Invention

[0005] Disclosed is an ultrasound imaging system comprising a disposable endovascular catheter with a non-volatile memory for use tracking. The endovascular catheter communicates with a manufacturer's workstation capable of writing data to the non-volatile memory, a clinical workstation operating the catheter to retrieve medical data from the patient while the catheter is positioned within the patient, and a reprocessor's workstation capable of writing encrypted data to a region of the non-volatile memory. The system tracks the number of authorized uses, the number of times the catheter has been used, and the maximum allowed duration of use for a given catheter to ensure proper reprocessing between uses. The catheter's memory is subdivided such that the reprocessor's workstation has the ability to modify only a limited portion of the memory. The system relies on data stored within the catheter itself, as well as information and software stored on and operated on a remote server accessible via web applications, mobile applications, or similar remote access architectures. This disclosure advantageously provides a mechanism for accurately tracking the use, reprocessing, and reuse of catheters, thus providing a solution to the aforementioned problems.

[0006] One general aspect includes an endoluminal imaging catheter comprising: a flexible elongated member configured to be positioned within a patient's body lumen; an ultrasound transducer array coupled to the flexible elongated member and configured to acquire imaging data when positioned within the body lumen; and a memory comprising a plurality of regions, each of the plurality of regions being configured to store one or more values ​​for one or more fields, wherein the plurality of regions include a first region, wherein one or more fields in the first region include at least one of a device identifier, a serial number, or a manufacturing date, wherein the plurality of regions include at least a second region, wherein one or more fields in the at least second region include a current usage count, maximum number of uses, and status of the endoluminal imaging catheter.

[0007] A system may include an intraluminal imaging catheter and one or more processor circuits communicatively coupled to the intraluminal imaging catheter. The one or more processor circuits may be part of one or more computers. The processor circuits and / or the computer may be configured to perform specific operations or actions because software, firmware, hardware, or combinations thereof are installed that, in operation, cause or result in the processor circuits and / or the computer performing these actions. One or more computer programs may be configured to perform specific operations or actions because they include instructions that, when executed by a data processing device, cause the device to perform these actions. Embodiments of the technology may include hardware, methods, or processes, or computer software on a computer-accessible medium.

[0008] The implementation may include one or more of the following features. One or more fields in the second region include a single use period and a timestamp indicating the start of current use. One or more fields in the first region include two or more of a device identifier, serial number, or manufacturing date. The multiple regions also include a third region, wherein one or more fields in the third region include the status of the endoluminescent catheter, and one or more fields in the second region include a current use count and a maximum number of uses. One or more values ​​in the second region and one or more values ​​in the third region are encrypted in different ways. One or more values ​​in the second region and one or more values ​​in the third region are encrypted based on one or more values ​​in the first region. One or more values ​​in the third region for the status of the endoluminescent catheter include: an unlocked value representing authorized use of the endoluminescent catheter when it is connected to a clinical console; a value representing use during the initial connection of the endoluminescent catheter to the clinical console; or a locked value representing a subsequent connection of the endoluminescent catheter to the clinical console. One or more values ​​in the third region for the status of the endoluminescent catheter include: a permanently locked value representing the connection of the endoluminescent catheter to the clinical console when its use exceeds the maximum number of uses. The intraluminal imaging catheter may include: a communication cable terminating at a connector, wherein a memory is disposed within the connector; and a handle configured to control at least one of the positions or orientations of an ultrasound transducer array within a body lumen, wherein the handle is coupled to the communication cable and a flexible elongated member, and the ultrasound transducer array is configured for intracardiac echocardiography (ICE).

[0009] One general aspect includes an endoluminal imaging system comprising: an endoluminal imaging catheter including: a flexible elongated member configured to be positioned within a patient's body lumen; an ultrasound transducer array coupled to the flexible elongated member and configured to acquire imaging data when positioned within the body lumen; a non-volatile memory; and one or more processor circuits communicating with the endoluminal imaging catheter and configured to operate the ultrasound transducer array to acquire imaging data; and writing information including: the number of times the endoluminal imaging catheter can be used; the number of times the endoluminal imaging catheter has been used; and the state of the endoluminal imaging catheter, including at least one of locked, unlocked, or in use, wherein the one or more processor circuits will not operate the ultrasound transducer array when the endoluminal imaging catheter is locked, or when the number of times the endoluminal imaging catheter has been used is equal to or greater than the number of times the endoluminal imaging catheter has been used. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform these actions.

[0010] Implementations may include one or more of the following features: An intraluminal imaging catheter, wherein one or more processor circuits are configured to: set the state of the intraluminal imaging catheter to "in use" while the intraluminal imaging catheter is being used; set the state of the intraluminal imaging catheter to "locked" after use; or set the state of the intraluminal imaging catheter to "unlocked" during reprocessing of the intraluminal imaging catheter. An intraluminal imaging catheter, wherein information written to non-volatile memory by one or more processor circuits further includes a checksum. An intraluminal imaging catheter, wherein at least a portion of the information written to non-volatile memory by one or more processor circuits is encrypted. An intraluminal imaging catheter, wherein the information written to non-volatile memory by one or more processor circuits further includes: a maximum duration of use of the intraluminal imaging catheter per instance; and a timestamp indicating the start time of use of the intraluminal imaging catheter. An intraluminal imaging catheter, wherein one or more processor circuits include a timer. An intraluminal imaging catheter, wherein once the difference between the timer and the timestamp equals or exceeds the maximum duration, one or more processor circuits are configured to change the state of the intraluminal imaging catheter to "locked". An endoluminal imaging catheter, wherein when the endoluminal imaging catheter is in use and the difference between a timer and a timestamp is less than a maximum duration, the endoluminal imaging catheter will be configured to repeatedly connect to and disconnect from a clinical workstation without triggering one or more processor circuits to change the state of the endoluminal imaging catheter from in use to locked. Implementations of the technology may include hardware, methods or processes, or computer software on a computer-accessible medium.

[0011] One general aspect includes an endoluminal imaging system comprising: an endoluminal imaging catheter including: a flexible elongated member configured to be positioned within a patient's body lumen; an ultrasound transducer array coupled to the flexible elongated member and configured to acquire imaging data when positioned within the body lumen; and a non-volatile memory configured to communicate with a manufacturer's workstation including first processor circuitry, a clinical workstation including second processor circuitry, and a reprocessor's workstation including third processor circuitry, such that: the manufacturer's workstation writes an unlocked status value and the number of times the endoluminal imaging catheter can be used to the non-volatile memory, while the clinical workstation operates the endoluminal imaging catheter and writes to the non-volatile memory. The endoluminal imaging system further includes: a usage counter that increments each time the endoluminal imaging catheter is operated; a usage status value that replaces the unlocked status value while the endoluminal imaging catheter is being operated; and a locked status value that replaces the usage status value after a given time has elapsed since the endoluminal imaging catheter was first operated. The reprocessor's workstation writes an unlocked status value to the endovascular imaging catheter, replacing one or both of the in-use or locked status values. If the locked status value is in non-volatile memory, or if the usage counter contains a value greater than the number of times the endovascular imaging catheter can be used, the clinical workstation will not operate the endovascular imaging catheter. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of this method.

[0012] Implementations may include one or more of the following features: The intraluminal imaging system also includes a manufacturer's workstation. The intraluminal imaging system also includes a clinical workstation. The intraluminal imaging system also includes a reprocessor's workstation, wherein the reprocessor's workstation also includes a license status value selected from licensed or unlicensed. The intraluminal imaging system also includes a remote server communicating with the reprocessor's workstation, wherein the remote server is configured to be accessed via an application executed by a third processor circuitry of the reprocessor's workstation. Implementations of the technology may include hardware, methods, or processes, or computer software on a computer-accessible medium.

[0013] This ultrasound imaging system has specific, but not exclusive, applications in intracardiac echocardiography. Other aspects, features, and advantages of this disclosure will become apparent from the following detailed description. Attached Figure Description

[0014] Exemplary embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

[0015] Figure 1 This is a schematic diagram of an exemplary imaging system according to an embodiment of the present disclosure.

[0016] Figure 2 This is a perspective view of an example imaging assembly positioned for coupling to a catheter according to an embodiment of the present disclosure.

[0017] Figure 3 An exemplary proximal portion of a catheter cable is shown, with a connector attached to the proximal portion of the catheter.

[0018] Figure 4 This is a schematic diagram of an exemplary reprocessing workstation according to at least one embodiment of the present disclosure.

[0019] Figure 5 This is a schematic diagram of an exemplary information flow between a manufacturing workstation, a clinical workstation, and a reprocessing workstation according to at least one embodiment of the present disclosure.

[0020] Figure 6 This is a flowchart illustrating exemplary motion according to at least one embodiment of the present disclosure, indicating the use of a tracked disposable intraluminal imaging catheter and device information stored thereon.

[0021] Figure 7 A more detailed flowchart is provided, indicating exemplary processing steps for a single-use intraluminal imaging catheter that has undergone multiple use and reprocessing cycles, according to at least one embodiment of this disclosure.

[0022] Figure 8 An exemplary initial state of the non-volatile memory of a disposable intraluminal catheter leaving the manufacturer according to at least one embodiment of the present disclosure is shown.

[0023] Figure 9 An exemplary state of a non-volatile memory for a disposable intraluminal catheter with use tracking according to at least one embodiment of the present disclosure is shown.

[0024] Figure 10 An exemplary state of a non-volatile memory for a disposable intraluminal catheter with use tracking according to at least one embodiment of the present disclosure is shown.

[0025] Figure 11 An exemplary state of a non-volatile memory for a disposable intraluminal catheter with use tracking, according to at least one embodiment of the present disclosure, is shown.

[0026] Figure 12 An exemplary state of a non-volatile memory for a disposable intraluminal catheter with use tracking, according to at least one embodiment of the present disclosure, is shown.

[0027] Figure 13 An exemplary state of a non-volatile memory for a disposable intraluminal catheter with use tracking according to at least one embodiment of the present disclosure is shown.

[0028] Figure 14 An exemplary state of a non-volatile memory for a disposable intraluminal catheter with use tracking according to at least one embodiment of the present disclosure is shown.

[0029] Figure 15 This is a schematic diagram of a processor circuit according to an embodiment of the present disclosure. Detailed Implementation

[0030] The disclosed invention is an ultrasound imaging system comprising an intraluminal imaging catheter, a non-volatile memory, a manufacturer's console or workstation capable of writing encrypted or unencrypted data to three different regions of the non-volatile memory, a clinical console or workstation capable of writing encrypted data to two of the three regions of the non-volatile memory, and a reprocessor's console or workstation capable of writing encrypted data to one of the three regions of the non-volatile memory. The system tracks the number of times a given catheter has been authorized for use, the number of times it has been used, the maximum allowed duration of use, and other necessary relevant information to prevent unauthorized reuse and to ensure proper reprocessing between uses.

[0031] Dividing non-volatile memory into at least two regions (e.g., three distinct regions: a common read-only region and two encrypted and potentially checksumable read-write regions) allows for secure reprocessing / reuse techniques. This is because reprocessors can modify a portion of the memory (e.g., changing a status variable from "in use" or "locked" to "unlocked") to advantageously allow reuse, but can only modify specific parts of the memory, thus advantageously ensuring security such that the device can be reused no more times than the manufacturer-determined safe number. Encryption and checksumming of the read / write regions prevent unauthorized users from accessing or altering information, thereby ensuring that the device cannot be reused if properly reprocessed by an unauthorized party. When implemented on the manufacturer's workstation, clinical workstation, reprocessor's workstation, and the sensor device itself, this system allows for convenient, secure, traceable, and verifiable reuse of medical sensors.

[0032] Generally, encouraging clinical users to update the software on clinical intraluminal imaging workstations is challenging, as the system relies on data stored within the catheter itself, as well as information and software stored on and operated on remote servers accessible via web applications, mobile applications, or similar remote access architectures.

[0033] For the purpose of facilitating an understanding of the principles of this disclosure, reference will now be made to the embodiments shown in the accompanying drawings, and the embodiments described therein will be used in specific language. However, it should be understood that there is no limitation on the scope of this disclosure. Any changes and further modifications to the described apparatus, systems, and methods, as well as any further application of the principles of this disclosure, are fully contemplated and included within the scope of this disclosure, as would typically be apparent to those skilled in the art to which this disclosure relates. For example, although the ICE system is described in the manner of intraluminal imaging, it should be understood that it is not intended to be limited to this application. Specifically, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the invention. However, for the sake of brevity, various repetitions of these combinations will not be described separately.

[0034] Figure 1 This is a schematic diagram of an exemplary imaging system 100 according to an embodiment of the present disclosure. System 100 may include an intraluminal ultrasound imaging device 110, a control and processing system 130 (e.g., a console including a computer), and a patient interface module (PIM) 131 extending between the device 110 and the control and processing system 130.

[0035] The ultrasound imaging device 110 may include a catheter 101. The catheter 101 may include one or more flexible elongated members that are sized and shaped, structurally arranged, and / or otherwise configured to be positioned within a patient's body lumen. In some embodiments, the catheter 101 includes an ultrasound imaging assembly 102, a catheter body or shaft 101a, a communication cable 103, a handle 120, and a connector 125. In some embodiments, the catheter body / shaft 101a and the catheter communication cable 103 may be referred to as flexible elongated members. The catheter shaft 101a is sized and shaped, structurally arranged, and / or otherwise configured to be positioned within a patient's body lumen (e.g., a vascular system such as a blood vessel or heart chamber). A corresponding portion of the catheter communication cable 103 extends within the catheter shaft 101a, the handle 120, and the connector 125. An imaging assembly or probe tip 102 may be attached to the distal end of the catheter shaft 101. The catheter shaft 101a may include a lumen through which a catheter communication cable 103 may pass. The proximal end of the catheter shaft 101a may be attached to a control handle 120, for example, via an elastic strain relief section. The control handle 120 may be used to manipulate and manually control the ultrasound imaging device 110. The ultrasound imaging device 110 may include an imaging assembly 102 with ultrasound transducer elements and associated circuitry. The handle 120 may include actuators, clutches or brakes, and other steering control components for steer the ultrasound imaging device 110.

[0036] The catheter communication cable 103 may pass through one or more of the catheter shaft 101a, handle 120, and connector 125. In some embodiments, during assembly, the catheter communication cable 103 may be electrically and mechanically coupled to the imaging assembly 102 and may include multiple wires.

[0037] Cable 103 can be configured to provide a suitable configuration for interconnecting the clinical control and processing system 130 and monitor 132 with the imaging component 102. The clinical control and processing system 130 can be used to process, store, analyze, and manipulate data, while the monitor 132 can be used to display acquired signals generated by the imaging component 102. The clinical control and processing system 130 (also referred to herein as a control and processing system, processing system, clinical workstation, or base station) may include one or more processors, memory, one or more input devices such as a keyboard, and any suitable command and control interface device. The control and processing system 130 is operable to facilitate the features of the endoluminal imaging system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-transitory tangible computer-readable medium. The monitor 132 may be any suitable display device, such as an organic light-emitting diode (OLED), liquid crystal display (LCD) panel, etc., and may include a touchscreen interface.

[0038] During operation, a physician or clinician may advance catheter 101 into a lumen, such as a blood vessel, body cavity, or part of the heart's anatomy. By manipulating controls on handle 120, the physician or clinician can steer catheter 101 to a position near the area of ​​interest to be imaged. The imaging process may include activating an ultrasound transducer element on imaging assembly 102 to generate ultrasound energy. A portion of the ultrasound energy is reflected by the area of ​​interest and surrounding anatomical structures, and the ultrasound transducer element receives ultrasound echo signals. Cable 103 can be used to transmit the received echo signals to control and processing system 130, where the ultrasound image is reconstructed and displayed on monitor 132. In some embodiments, processing system 130 may control the activation of ultrasound transducer elements and the reception of echo signals. In some embodiments, control and processing system 130 and monitor 132 may be part of the same system.

[0039] While some embodiments of this disclosure refer to imaging devices, ultrasound imaging devices, or intraluminal imaging devices, it should be understood that ultrasound imaging device 110 and system 100 can generally be used to image blood vessels, structures, lumens, and / or any suitable anatomical structures / tissues within a patient's body, including any number of anatomical locations and tissue types, including but not limited to: organs, including the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures, including the brain, dura mater, spinal cord, and peripheral nerves; urinary tracts; and valves within the blood, chambers, or other parts of the heart, and / or other systems of the body. In addition to natural structures, imaging device 110 can also be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices. For example, ultrasound imaging device 110 can be positioned within a fluid-filled or enclosed structure, including both natural and artificial ones, such as within a patient's body. Blood vessels, structures, lumens, and anatomical structures / tissues can include blood vessels that are arteries or veins as part of the patient's vascular system, including cardiac vessels, peripheral vessels, neurovascular vessels, renal vessels, and / or any suitable lumens within the body.

[0040] System 100 may be referred to as an imaging system, an ultrasound imaging system, an intraluminal imaging system, and / or combinations thereof. Although this disclosure refers to ICE catheters, any suitable intraluminal imaging device or intraluminal sensing device is contemplated, such as intravascular ultrasound (IVUS) devices, optical coherence tomography (OCT) devices, intracardiac echocardiography (ICE) devices, transesophageal echocardiography (TEE) devices, intraluminal photoacoustic (IVPA) imaging devices, pressure-sensing guidewires or catheters, flow-sensing guidewires or catheters, and / or any suitable internal imaging or sensing device. Intraluminal devices with flexible, elongated components, such as catheters, guidewires, and / or guiding catheters, are contemplated.

[0041] System 100 can be used in a variety of applications, such as transseptal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair, and can be used to image blood vessels and structures in vivo. Although System 100 is described in the context of an intraluminal imaging procedure, System 100 is suitable for any catheterization procedure. Furthermore, the imaging assembly 102 may include any suitable physiological sensors or components for diagnosis, treatment, and / or therapy. For example, the imaging assembly may include imaging components, ablation components, cutting components, fragmentation components, pressure sensing components, flow sensing components, temperature sensing components, and / or combinations thereof. In some embodiments, the intraluminal imaging system 100 is used to generate two-dimensional and three-dimensional images.

[0042] refer to Figure 1The PIM 131 provides physical and electrical connectivity between the ultrasound imaging device 110 and the clinical control and processing system 130. Some embodiments of this disclosure omit the PIM 131. In other embodiments, the PIM 131 is communicatively inserted between the ultrasound imaging device 110 and the processing system or clinical workstation 130. In some cases, the PIM 131 may be referred to as a patient interface cable. For example, the proximal connector 209 of the ultrasound imaging device 110, the distal connector of the PIM, and / or the proximal connector of the PIM may be configured to mechanically and electrically connect the ultrasound imaging device 110, the PIM 131, and the control and processing system. System 100 may include a connector joint 111 comprising the proximal connector 125 of the ultrasound imaging device 110 and the distal connector of the PIM 131.

[0043] 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 mechanically and electrically connected to the control and processing system 130, such that electrical signals are transmitted through the PIM 131 to the ultrasound imaging device 110 and to the control and processing system 130. The control and processing system 130 may include one or more processors and / or storage modules forming processing circuitry that processes the electrical signals and outputs a graphical representation of the imaging data on a monitor 132. One or more electrical conductors in the ultrasound imaging device 110 and the 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 through a control interface 134 of the control and processing system 130. Electrical signals representing commands from the control and processing system 130 may be transmitted to the ultrasound imaging device 110 through 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 user transport.

[0044] In some embodiments, one or more components of the ultrasound imaging device 110 may be disposable. For example, a user (e.g., a physician) may receive the catheter 101 and / or the ultrasound imaging device 110 in sterilized packaging. In some embodiments, the ultrasound imaging device 110 may be discarded or disposed of after a single use. In other embodiments, the ultrasound imaging device 110 may be sterilized and / or reprocessed for more than one use. The PIM 131 may be a reusable component used in multiple operations. For example, the PIM 131 may be cleaned between operations, such as by treating it with a disinfectant to kill bacteria. In some embodiments, the PIM 131 may not need to be sterilized before a medical procedure. For example, the PIM 131 may be adequately spaced from the patient, making it safe for the patient to use a non-sterilized PIM 131. A sterile-non-sterile connection at the connector assembly 111 between the ultrasound imaging device 110 and the PIM 131 allows for a safe operating environment while saving costs by allowing expensive equipment to be reused.

[0045] Figure 2 This is a perspective view of an exemplary imaging assembly 102 according to an embodiment of the present disclosure, positioned for coupling to a conduit 101. The imaging assembly 102 is shown as an imaging core 262, positioned appropriately within the end member 200. The imaging core 262 is coupled to a cable 266 via an electrical interconnect 264. The cable 266 passes through an alignment portion 244 and an interface portion 246 of the lumen 250. The cable 266 may further extend through a flexible elongated member 101, such as... Figure 1 As shown.

[0046] Imaging core 262 may include an array of ultrasound transducers. Imaging core 262 and / or the ultrasound transducer array are configured to acquire imaging data of a patient's anatomy when positioned within a body lumen. The ultrasound transducer array may be an array of acoustic elements configured to emit ultrasound energy and receive echoes corresponding to the emitted ultrasound energy. In some cases, the array may include any number of ultrasound transducer elements. For example, the array may include values ​​between 2 and 10,000 acoustic elements, including values ​​such as 2, 4, 64, 128, 500, 812, 3,000, 9,000, and / or other values ​​larger and smaller. In some cases, the transducer elements of the array can be arranged in any suitable configuration, such as linear arrays, planar arrays, arc arrays, curved arrays, circular arrays, ring arrays, phased arrays, matrix arrays, one-dimensional (1D) arrays, 1.x-dimensional arrays (such as 1.5D arrays), or two-dimensional (2D) arrays. The array of transducer elements (e.g., one or more rows, one or more columns, and / or one or more orientations) can be controlled and activated uniformly or independently. The array can be configured to acquire one-dimensional, two-dimensional, and / or three-dimensional images of the patient's anatomy.

[0047] The ultrasonic transducer elements may include piezoelectric / piezoresistive elements, piezoelectric micromechanical ultrasonic transducer (PMUT) elements, capacitive micromechanical ultrasonic transducer (CMUT) elements, and / or any other suitable type of ultrasonic transducer element. The ultrasonic transducer elements in the array communicate with (e.g., are electrically connected to) electronic circuitry. For example, the electronic circuitry may include one or more transducer control logic chips. The electronic circuitry may include one or more integrated circuits (ICs), such as application-specific integrated circuits (ASICs). In some embodiments, one or more ICs may include a microwave beamformer (μBF). In other embodiments, one or more ICs include a multiplexer circuit (MUX).

[0048] The configuration and structure of the aforementioned distal end member 200 offer several benefits, such as safe and easy delivery for catheterization, improved tensile strength for steering or navigation, consistent or automatic alignment, and improved image quality. For example, the external geometry of the distal end member 200 is configured to provide smooth surfaces and smooth edges with small radii. Smooth edges reduce friction as the distal end member 200 passes through a blood vessel during insertion. Smooth surfaces prevent tearing and / or damage to tissue structures during insertion. Furthermore, smooth edges and smooth surfaces can facilitate perforation of septa or other anatomical features during catheterization. The material type and wall thickness of the distal end member 200 are selected to minimize acoustic distortion, attenuation, and / or reflection. The internal geometry of the distal end member 200 is configured to facilitate alignment during manufacturing. The distal end member 200 may also include other features, such as guidewire lumens, orifices, or other geometries, to accommodate additional devices or features, such as pressure sensors, drug delivery mechanisms, and / or any suitable interventional features.

[0049] Figure 3 An exemplary catheter cable proximal to a connector 125 attached to the proximal portion of catheter 101 is shown. Connector 125 includes a housing 310, a printed circuit board assembly (PCBA) 320 including one or more electronic components, and non-volatile memory 330, such as read-only memory (ROM), programmable read-only memory (PROM), electrically erasable read-only memory (EEPROM), magnetic or electronic random access memory (RAM), flash memory, etc. The non-volatile memory 330 stores state variables that can be written to by one or more of the manufacturer's, clinical workstation 130's, or reprocessor's workstations. In other embodiments, the EEPROM 330 may be located in other portions of catheter 101, such as handle 120 and / or end member 200. Generally, memory 330 may be coupled to catheter 101, such as a flexible elongated member of catheter 101 (e.g., catheter shaft and / or cable 103).

[0050] Figure 4This is a schematic diagram of an exemplary reprocessing workstation 450 according to at least one embodiment of the present disclosure. Cable 103 and connector 125 of conduit 101 are visible, connected to conduit connector 425 and workstation connector 435 of adapter 410. In some embodiments, connectors 125 and 425 are both proprietary interfaces designed to interconnect, while workstation connector 435 is a standard connector, such as a USB, micro USB, Lightning, or FireWire connector, which connects to the reprocessing workstation or reprocessor's workstation 450, thereby enabling the reprocessing workstation 450 to read from and write to non-volatile memory 330 within connector 125 of conduit 101. In other embodiments, adapter 410 is a wireless adapter. In still other embodiments, conduit connector 425 is directly integrated into the reprocessing workstation 450, eliminating the need for adapter 410.

[0051] In some embodiments, the reprocessing workstation 450 runs a local application that interacts with data on non-volatile memory 330. In other embodiments, the reprocessing workstation runs a remote application (e.g., a web application) that enables the remote server 455 to interact with data in non-volatile memory 330. In still other applications, the reprocessing workstation 450 runs a local application but exchanges data with the remote server (e.g., a license confirmation status value of "licensed" or "unlicensed"). The reprocessing workstation 450 can communicate with the remote server via a wired or wireless connection. Wireless connection protocols may include Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, 5G, or other suitable services or protocols. For example, a Bluetooth Low Energy (BLE) radio may be used to establish a connection to a cloud service.

[0052] According to embodiments, the reprocessing workstation 450 may be a server, cloud computer, desktop computer, laptop computer, tablet computer, or handheld device, and may include any combination of general-purpose computing devices, simplified instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. In some embodiments, the reprocessing workstation includes memory storing instructions or information upon which the processor operates. The memory may reside on the same board or chip as the processing elements, or it may be located outside the board or chip containing the processing elements. The memory may include any combination of read-only memory (ROM), programmable read-only memory (PROM), electrically erasable read-only memory (EEPROM), magnetic or electronic random access memory (RAM), flash memory, disk or tape drives, or other related memory types.

[0053] In some embodiments, the reprocessing workstation is operated by a licensed or otherwise authorized reprocessing entity. For example, the license may cover a specific number of devices (e.g., 100 devices), a specific number of reprocessing sessions (e.g., 100 reprocessing sessions), a specific time window (e.g., October), or may be continuously or automatically updated. In some embodiments, the reprocessing entity may also be an authorized reseller. In other embodiments, the reprocessing workstation is operated by the manufacturer or by the clinical user of catheter 101. In some embodiments, reprocessing may involve physical sterilization of the catheter (e.g., chemical, heat, or steam sterilization, or any combination thereof). In some embodiments, reprocessing may involve functional testing of catheter 101 to ensure its proper operation.

[0054] Figure 5 This is a schematic diagram of an exemplary information flow between manufacturing workstation 550, clinical workstation 130, and reprocessing workstation 450. Each of these workstations 550, 130, and 450 may include processor circuitry, a computer, a display, an input device (e.g., one or more of a keyboard, mouse, touchscreen, hard keys, soft keys, etc.), a console, or a mobile device. A traceable, single-use endoluminal imaging catheter 101 is manufactured, and its EEPROM 330 is written to by manufacturing workstation 550. From there, catheter 101 can be shipped directly to the clinical environment, where it is inserted into clinical workstation 130, which is also capable of reading and writing EEPROM 330, such that the use of catheter 101 is recorded in EEPROM 330, as described below. Alternatively, catheter 101 may be shipped to a distributor / reprocessor, who then ships it to the clinical environment. Once catheter 101 has been used, it is disconnected from clinical workstation 130 and shipped to the distributor / reprocessor for reprocessing. The distributor / reprocessor connects catheter 101 to reprocessing workstation 450, which updates the information in EEPROM 330, making catheter 101 reusable. Catheter 101 is then transported back to the clinical environment (or a different clinical environment) where it can be reused (e.g., inserted into clinical workstation 130). Catheter 101 can be transported back and forth between the clinical and reprocessing environments multiple times, the same number of times the manufacturer specifies that catheter 101 can be used. For example, the manufacturer may specify that a particular use-tracking disposable endoluminal imaging catheter 101 is a single-use device, a multiple-use device (e.g., 5 uses), or a substantially reusable device (e.g., 100 or more uses).

[0055] Figure 6This refers to a flowchart illustrating exemplary movement of a disposable intraluminal imaging catheter 101 with use tracking according to at least one embodiment of the present disclosure, and changes to device information stored thereon.

[0056] In step 610, the user connects catheter 101 to a clinical workstation or base station 130, such as an ultrasound system. Catheter 101 may be a new device shipped from a manufacturer or distributor, or it may be a reprocessed device shipped from a reprocessor.

[0057] In step 620, the clinical workstation or base station 130 updates the information stored in the non-volatile memory 330 of the catheter 101 to indicate the start of new use of the catheter 101. In one example, use is limited to a certain duration or period of use (e.g., 8 hours), which is specified by a value stored in the non-volatile memory 330 of the catheter 101, as described below, and within this duration, the catheter 101 can be connected to and disconnected from the clinical workstation or base station as needed or desired multiple times.

[0058] In step 630, if catheter 101 is connected to or remains connected to clinical workstation or base station 130 for a specified period of time, clinical workstation or base station 130 causes catheter 101 to be "locked". The locked state is specified by a value stored in non-volatile memory 330 of catheter 101, as described below. In one example, when catheter 101 is in a locked state, clinical workstation or base station 130 will not operate catheter 101 and may display error messages or user instructions for reprocessing catheter 101.

[0059] In step 640, the clinical user transports catheter 101 to a reprocessor for reprocessing. According to embodiments, the device may be given, sold, lent, leased, or otherwise transferred. In one example, the information stored in the non-volatile memory 330 of catheter 101 includes a serial number, thus allowing easy tracking of the device's identity and ownership.

[0060] In step 650, the reprocessor connects catheter 101 to reprocessing workstation 450, which reads a status variable stored in non-volatile memory 330. If the status variable indicates catheter 101 is “locked” or “in use”, but has more uses available (e.g., it has been used 3 times out of a maximum of 5 allowed uses), reprocessing workstation 450 writes new information to the status variable to unlock the device, as described below. The reprocessor can then give, sell, lend, rent, or lease catheter 101 to a clinical user, or a different clinical user. In some examples, the reprocessor cleans or sterilizes the catheter (e.g., using heat, chemicals, autoclave, pressure, steam, or boiling water) and / or tests the catheter’s proper functioning before returning it to clinical use. The operation of catheter 101 then returns to step 610 until all uses of catheter 101 have been exhausted.

[0061] Figure 7 The flowchart is more detailed and indicates exemplary steps in method 700 according to at least one embodiment of the present disclosure for use tracking of a disposable intraluminal imaging catheter 101 through multiple use and reprocessing cycles.

[0062] In step 710, the conduit 101 is manufactured, at which point certain initial information is written into its non-volatile memory 330, as described below.

[0063] In step 720a, catheter 101 is received by the clinical user. The catheter may have been shipped directly from the manufacturer or may have passed through one or more distributors or dealers before reaching the clinical user.

[0064] In step 730a, the clinical user connects catheter 101 to clinical workstation 130. From this initial connection, the clinical workstation then increments a usage counter (e.g., from 0 to 1) within the non-volatile memory 330 of catheter 101. Catheter 101 then begins its first use, wherein clinical workstation 130 marks it as "in use" by writing status information to the non-volatile memory 330 of catheter 101, and also writes a timestamp value indicating the date and time of the start of use to the non-volatile memory 330, as described below.

[0065] In step 740a, the clinical user employs the device in a clinical procedure (e.g., an intraluminal ultrasound imaging procedure for assessing anatomical structures). For example, using catheter 101 may include the processor circuitry of clinical workstation 130 controlling catheter 101 to emit ultrasound energy and receive echoes reflected from anatomical structures. The processor circuitry of clinical workstation 130 may process imaging data representing the received echoes and generate and display ultrasound images based on the imaging data. Throughout the period of use (including one or more disconnections and reconnections of catheter 101 and clinical workstation 130), clinical workstation 130 compares the current date and time with a timestamp and a maximum usage duration. If the current date and time exceeds the sum of the timestamp and the maximum usage duration, clinical workstation 130 disables the use of catheter 101 and writes a status message indicating that catheter 101 is now locked to non-volatile memory 330, as described below. In some embodiments, this locking or disabling of the catheter is not enforced during use to prevent interruption of ongoing medical procedures, but only after the catheter is disconnected from and reconnected to the system.

[0066] In step 750a, if catheter 101 is locked and will not be operated by clinical workstation 130, clinical workstation 130 displays an error message and instructs the clinical user to disconnect catheter 101 from clinical workstation 130 and send catheter 101 to a reprocessor for reprocessing before it can be reused. Alternatively, if the clinical operation is completed and the maximum use duration has not expired, catheter 101 can be disconnected while still marked as in use, as described below. Catheter 101 can also be sent to a reprocessor in this state, and in some examples this may be the normal result. It should be noted that if the disconnected catheter 101 in use is reconnected to clinical workstation 130 after its maximum use duration has expired, clinical workstation 130 will mark catheter 101 as locked by writing appropriate status information to non-volatile memory 330. In this case, clinical workstation 130 will allow catheter 101 to also be sent to a reprocessor for reprocessing before it can be reused.

[0067] In step 760a, catheter 101 is received by a reprocessing entity. In this case, catheter 101 will typically be marked as in use or locked by clinical workstation 130. In one example, upon receiving catheter 101 and before connecting it to reprocessing workstation 450, the reprocessing entity (e.g., a company) will clean or disinfect catheter 101 (e.g., with heat, chemicals, steam, or boiling water) and test its normal function.

[0068] In step 770a, the reprocessing entity connects catheter 101 to reprocessing workstation 450, which reads status information stored in non-volatile memory 330. If catheter 101 is marked as unlocked (e.g., authorized for use), the reprocessor has mistakenly received it and may return it to the clinical user or a different clinical user for normal clinical use. If catheter 101 is marked as in use or locked, reprocessing workstation 450 checks if catheter 101 has any remaining uses. In the case of a single-use catheter, reprocessing is not permitted (e.g., the allowed number of uses is one), the reprocessing workstation marks catheter 101 as locked and may instruct the reprocessor to discard catheter 101. If catheter does have remaining uses, the reprocessing workstation may mark catheter 101 as unlocked so that it can be shipped back to the clinical user or a different clinical user. (Then, the clinical workstation will increment the use counter in non-volatile memory 330 of catheter 101 the next time the catheter is reconnected to the clinical workstation).

[0069] Method 700 further includes steps 720b-770b, which are similar to steps 720a-770a, and are applicable to the subsequent connection, use, and reprocessing of catheter 101. Clinical workstation 130 and reprocessing station 450 will allow these steps to be repeated multiple times, as long as there is a permitted number of uses of catheter 101.

[0070] Step 770d represents the last permitted reprocessing of catheter 101 (in this example, the fourth reprocessing, but it could be any number of reprocessings depending on the maximum number of uses specified in the state variable within non-volatile memory 330). Next is step 770e, where the clinical user finally receives catheter 101, and step 770e, where the catheter is finally connected to the clinical workstation 130. In step 740e, catheter 101 is used for the last time and disconnected at step 750e, its status being either in use or locked.

[0071] In step 760e, the reprocessor receives catheter 101 for the last time. When the device is connected to the reprocessing workstation 450, the reprocessing workstation detects that catheter 101 has no remaining uses, marks it as locked, and may set the number of uses equal to the maximum number of uses. In one example, the reprocessing workstation 450 may recommend discarding catheter 101. In step 780, the used, single-use intraluminal catheter is discarded (e.g., as trash or medical waste).

[0072] Figure 8An exemplary initial state of fields or status values ​​within the non-volatile memory 330 is shown when the traced disposable intraluminal catheter 101 leaves the manufacturer, according to at least one embodiment of the present disclosure. In some embodiments, the non-volatile memory 330 is divided into three regions: an unencrypted public data region 810 (also referred to as region 1), an encrypted private manufacturer information region 820 (also referred to as region 2), and a private reprocessor information region 830 (also referred to as region 3). It should be understood that regions 810, 820, and 830 refer to data that can be accessed by one or more processors and stored according to the storage structure (e.g., memory cells, bits, data blocks, etc.) within the memory 330. Regions 810, 820, and 830 may, but do not necessarily, refer to physical space within the memory 330. Accordingly, while data may belong to regions 810, 820, and 830, they may be written to various physical spaces within the memory 330. In one example, the public data area 810 includes fields containing fixed, immutable information such as device ID or type, device serial number, device calibration date, manufacturing date, and other relevant information required depending on the implementation. The information stored in area 810 can be public because the data can be read by any workstation, including clinical workstation 130 and reprocessor workstation 450. In some embodiments, the information is unencrypted, although in other embodiments it can be encrypted using appropriate methods.

[0073] In some embodiments, the manufacturer manufactures all of the imaging device 101, clinical workstation 130, and reprocessing workstation 450. In other embodiments, the manufacturer manufactures the imaging device 101 such that it is configured for use with a clinical workstation 130 from another manufacturer.

[0074] The proprietary manufacturer information area 820 (e.g., area 2) includes fixed, immutable information specified by the manufacturer and cannot be changed by the clinical workstation 130 or the reprocessor workstation 450. This information may include a usage counter, the maximum allowed number of uses (e.g., 5, 100, or 1000 times), the maximum allowed elapsed time per use, and other relevant information as required by the implementation. The proprietary manufacturer information area 820 also includes variable information whose initial value is set by the manufacturer but can be dynamically updated by the clinical workstation 130. This information may include a current device usage count (e.g., the number of times catheter 101 has been used in clinical procedures) and a timestamp indicating the start of the current use (e.g., the date and time catheter 101 was connected to the clinical workstation, as described above in steps 730a and 730b). In one example, both variables are set to zero by default. This information may also include other necessary variables, depending on the implementation. In some embodiments, the proprietary manufacturer information area 820 is encrypted using appropriate methods to prevent unauthorized parties from attempting to tamper with the information (e.g., falsifying information or allowing additional uses beyond the manufacturer-specified maximum).

[0075] The private reprocessing information area 830 (also referred to as area 3) is the only portion of the non-volatile memory 330 that the reprocessor workstation 450 can write to. This provides the necessary security, allowing the manufacturer to control reuse. The clinical workstation 130 can write to both the private manufacturing information area 820 (area 2) and the private reprocessing information area 830 (area 3). This provides access to variables in the non-volatile memory 330 that the manufacturer can use to control reuse.

[0076] The private reprocessing information area 830 contains a status variable indicating whether the conduit 101 is unlocked, in use, or locked. In one example, this status variable is set to unlocked by default at manufacturing time. In some embodiments, the status variable may hold additional values, including but not limited to permanent lock, recall, damage, experimentation, demonstration, permanent unlock, error, or other values ​​required according to the implementation. In some embodiments, the private reprocessing information area 830 is encrypted using appropriate methods to prevent unauthorized parties from attempting to tamper with the information (e.g., falsifying information or allowing additional uses beyond the maximum value specified by the manufacturer).

[0077] Generally, memory 330 may include two or more regions. In some embodiments, data is stored in two regions of memory 330. For example, a first region stores public data, and a second region stores private, secure, and / or encrypted data. In some embodiments, the first region may be similar to region 810 and store information such as device ID or type, device serial number, device calibration date, manufacturing date, and / or other necessary related information, depending on the implementation. In some embodiments, the second region may be similar to regions 820 and 830 and store a usage counter, the maximum allowed number of uses (e.g., 5 uses, 100 uses, or 1000 uses), the maximum allowed elapsed time per use, a status value representing the state of the device, and / or other relevant information indicating what is required according to the implementation.

[0078] Figure 9 An exemplary state of the nonvolatile memory 330 during step 740a (e.g., when catheter 101 is used by clinical workstation 130) according to at least one embodiment of the present disclosure is shown.

[0079] Clinical workstation 130 reads non-volatile memory 330 to verify whether catheter 101 is permitted for use. For example, clinical workstation 130 may compare the current usage count with the maximum number of uses to ensure that the current usage value is less than the maximum (e.g., the catheter has at least one remaining amount of permitted use). The clinical workstation also sees that the value 830 of region 3 is set to "unlocked" (e.g., catheter 101 is new or has been correctly reprocessed by an authorized reprocessor). For example, if the number of uses of catheter 101 exceeds the maximum permitted number of uses, then clinical workstation 130 will refuse to operate on catheter 101, and reprocessor workstation 450 will refuse to reprocess catheter 101. If the time elapsed during the current use exceeds the maximum permitted duration, the clinical workstation will stop operating on catheter 101. If the value 830 of region 3 of the catheter is set to "locked," then clinical workstation 130 will refuse to operate on it, but reprocessor workstation 450 will allow it to be reprocessed. Therefore, after permitted use, if a customer attempts to reuse catheter 101 without it being reprocessed by an authorized reprocessor, one or more of the following will notify clinical workstation 130 not to operate the device: (a) the usage count exceeds the maximum permitted number of uses, (b) the time elapsed since activation exceeds the permitted single-use time period, or (c) the lock / unlock status is set to "locked". In each of these cases, the system will issue an error message to the user, instructing the user to disconnect catheter 101 and dispose of it as appropriate or return it to an authorized reprocessor.

[0080] Figure 9 The third column shows the data from... Figure 8 The previous values ​​(e.g., initial values ​​set by the manufacturer) are displayed in the first column, while the fourth column shows the values ​​set during step 740a, with changed values ​​highlighted and unchanged values ​​not highlighted. In this example, the current device usage count has been incremented from 0 to 1, the timestamp has been updated to the date and time of the start of current use (e.g., GMT time), and the reprocessing information status variable has been updated from unlocked to in use. Only storage areas 820 and 830 (e.g., areas 2 and 3) are shown in the figure because in most implementations, the information in the common data storage area 810 (e.g., area 1) cannot be changed by the clinical workstation 130. If catheter 101 is disconnected from clinical workstation 130 before the end of a single use period (e.g., the maximum allowed use period), the non-volatile memory 330 may be in the state shown in this figure when the device is sent to the reprocessor.

[0081] Figure 10 The state of the non-volatile memory 330 at step 750a is shown according to at least one embodiment of the present disclosure. The third column shows the state from... Figure 9 The previous values ​​(e.g., values ​​during the first clinical use of catheter 101) are shown in the first column, while the fourth column shows the values ​​that occur while catheter 101 remains connected to clinical workstation 130 until the single-use period has elapsed. In this case, clinical workstation 130 updates the reprocessing information state variable to locked. This is then the configuration that non-volatile memory 330 will have when catheter 101 is sent to the reprocessor.

[0082] Figure 11 The state of the non-volatile memory 330 after the processing in step 770a according to at least one embodiment of this disclosure is shown. The third column shows the state of the non-volatile memory 330 after the processing in step 770a according to at least one embodiment of this disclosure. Figure 10 The previous values ​​(e.g., values ​​after the first clinical use of catheter 101) are displayed in the first column, while the fourth column shows the values ​​after reprocessing. As highlighted, the only change is that the reprocessing information status variable 830 is updated from a value of "in use" or "locked" to a value of "unlocked".

[0083] Figure 12 The state of the non-volatile memory 330 during step 740b (e.g., during the second clinical use of catheter 101) according to at least one embodiment of the present disclosure is shown. As can be seen from the figure, the clinical workstation 130 updates the current device usage count from 1 to 2, updates the timestamp to the time when catheter 101 was connected to the clinical workstation 130, and updates the reprocessing information status variable 830 from unlocked to in use.

[0084] Figure 13The state of the non-volatile memory 330 after step 770d (e.g., after final reprocessing of catheter 101 with a maximum of 5 permitted uses) according to at least one embodiment of the present disclosure is shown. In the example shown in the figure, the current device usage count is 5, the maximum number of uses is 5, the single use time period is 8 hours, the timestamp holds the time and date of the start of the fourth clinical use of the catheter, and the reprocessing information status variable 830 has been changed from a used or locked value to an unlocked value by the reprocessing workstation 450.

[0085] Figure 14 The state of the non-volatile memory 330 during step 740e (e.g., during the last use of catheter 101 with 5 permitted uses in this laboratory example) according to at least one embodiment of the present disclosure is shown. In the example shown in the figure, clinical workstation 130 has updated the current device usage count from 4 to 5 and updated the timestamp to the date and time when the current clinical use began (e.g., when catheter 101 was first connected to clinical workstation 130 for that use). Clinical workstation 130 will also reprocess the information status variable 830 from unlocked to in use.

[0086] As described above, once the current system time displays a single use period of 8 hours from the start of use, the clinical workstation 130 will stop the operation of catheter 101 and may recommend disposal of catheter 101, or otherwise transport catheter 101 to a reprocessing center for disposal. In some embodiments, to prevent interruption of ongoing medical procedures, the catheter is not forcibly locked or otherwise disabled during use, but only after the catheter has been disconnected from and reconnected to the system.

[0087] Figure 15 This is a schematic diagram of a processor circuit 150 according to an embodiment of the present disclosure. The processor circuit 150 can be located in the clinical workstation 130, catheter 101, ... Figure 1 PIM 131, Figure 3 Connector 125, or Figure 4 Adapter 410, or Figure 5 The method may be implemented in any of the manufacturer's workstation 550 or reprocessor's workstation 450, or other devices or workstations required to implement the method (e.g., third-party workstations). As shown, the processor circuitry 150 may include a processor 160, a memory 164, and a communication module 168. These components may communicate directly or indirectly with each other, for example, via one or more buses.

[0088] Processor 160 may include a central processing unit (CPU), digital signal processor (DSP), ASIC, controller, FPGA, another hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 160 may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0089] Memory 164 may include cache memory (e.g., the cache memory of processor 160), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In one embodiment, memory 164 includes a non-transitory computer-readable medium. Memory 164 may store instructions 166. Instructions 166 may include instructions that, when executed by processor 160, cause processor 160 to perform the operations described herein with reference to workstations 130, 450, and 550 and / or imaging apparatus 101. Instructions 166 may also be referred to as code. The terms “instruction” and “code” should be interpreted broadly to include any type of computer-readable statement. For example, the terms “instruction” and “code” may refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "codes" can include a single computer-readable statement or many computer-readable statements.

[0090] Communication module 168 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between processor circuitry 150, imaging device 102, and / or display 108. In this respect, communication module 168 may be an input / output (I / O) device. In some cases, communication module 168 facilitates direct or indirect communication between processor circuitry 150 and / or various components of workstations 130, 450, or 550. Communication module 168 may communicate via a variety of methods or protocols. Serial communication protocols may include, but are not limited to, US SPI, I... 2 C. Serial and parallel communication may be carried out using methods or protocols such as RS-232, RS-485, CAN, Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communication may be bridged via UART, USART, or other suitable subsystems.

[0091] Many variations are possible with respect to the examples and embodiments described above. For example, according to an implementation, the incrementing of the current device usage count within the proprietary manufacturer region 820 of the nonvolatile memory 330 may be performed by the clinical workstation 130 during use, by the reprocessor's workstation 450 after use, within the adapter 410 after use, within the remote server 455 during or after use, within the catheter 101 itself before, during, or after use, or at any other location or step in achieving the disclosed results.

[0092] As another example, the encryption of the non-volatile memory 330 can be a hash function (e.g., the hash value of the device serial number), a symmetric key or public key encryption function, a one-time ciphertext, or any other suitable encryption method to achieve the disclosed effect. Furthermore, the non-volatile memory 330 may include a checksum value such that if any value in the non-volatile memory 330 is corrupted, hacked, incorrectly written to or altered, or changed in any way other than through the operations, steps, methods, and apparatus described above, such alteration will be revealed by a mismatch in the checksum. In some embodiments, it may be advantageous to checksum the unencrypted version of the data in the non-volatile memory 330 and / or encrypt the checksum itself to prevent unauthorized users from reverse engineering the checksum algorithm. While encryption is mentioned as a way to protect data on the memory 330, it should be understood that any suitable security techniques to prevent unauthorized access to specific data are contemplated. For example, password protection and / or software key-based security can be implemented.

[0093] The logical operations constituting embodiments of the technology described herein are referred to differently as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these operations may be performed, assembled, or arranged in any order unless expressly asserted otherwise, or the language of the assertion inherently requires a specific order.

[0094] It should be further understood that the technology can be used with other types of intraluminal instruments, including imaging and non-imaging sensors designed to study blood vessels, lumens, or organs of the body. Furthermore, the technology can be applied to fields completely separate from imaging / medicine. For example, it can be applied to household items, construction tools, or any other reusable devices that are connected to an underlying system for use and have a limited expected lifespan. Examples may include, but are not limited to, light bulbs, electric toothbrush heads, electric damper heads, and chainsaw blades.

[0095] All directional references, such as up, down, inside, outside, upward, downward, left, right, side, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal, are for identification purposes only to aid the reader in understanding the claimed subject matter and do not impose limitations, particularly regarding the location, orientation, or use of traceable single-use intraluminal catheters, clinical workstations, manufacturer's workstations, or reprocessor's workstations. The terms "connection," such as attachment, coupling, connection, and engagement, should be interpreted broadly and may include intermediate members located between component sets and relative movement between components, unless otherwise stated. Therefore, the term "connection" does not necessarily imply that two components are directly connected and mutually fixed. The term "or" should be interpreted as "and / or," not "exclusively or." Unless otherwise stated in the claims, numerical values ​​should be interpreted as illustrative only and not as limiting.

[0096] Those skilled in the art will recognize that the above-described devices, systems, and methods can be modified in various ways. Therefore, those skilled in the art will appreciate 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, extensive modifications, variations, and substitutions are contemplated in the foregoing disclosure. It should be understood that such variations can be made to the foregoing without departing from the scope of this disclosure. Therefore, a broad interpretation of the appended claims, consistent with this disclosure, is appropriate.

Claims

1. An intraluminal imaging catheter, comprising: A flexible, slender member configured to be positioned within a patient's body cavity; An ultrasonic transducer array is coupled to the flexible elongated member and configured to acquire imaging data when positioned within the body lumen. as well as A memory comprising multiple regions, each of which is configured to store one or more values ​​for one or more fields; The plurality of regions includes a first region, wherein the one or more fields in the first region include immutable information that can be read by any workstation adapted to connect to the intraluminal imaging catheter, which includes at least one of device identification, serial number or manufacturing date; The plurality of regions includes a second region, wherein one or more fields in the second region include immutable information specified by the manufacturer's workstation, containing at least one of the maximum allowed number of uses of the endovascular imaging catheter and the maximum allowed elapsed time per use, and the one or more fields in the second region also include variable information whose initial value is set by the manufacturer's workstation and which can be updated by at least one of the endovascular imaging catheter, a clinical workstation adapted to connect to the endovascular imaging catheter, and a reprocessor's workstation, the variable information containing at least one of the current number of uses and the start timestamp of the current use; and The plurality of regions further includes a third region, wherein one or more fields in the third region contain the status of the endoluminal imaging catheter written by at least one of the reprocessor's workstation, the clinical workstation, and the manufacturer's workstation, the status of the endoluminal imaging catheter including at least one of locked, unlocked, or in use.

2. The intraluminal imaging catheter according to claim 1, wherein, The one or more values ​​in the second region and the one or more values ​​in the third region are encrypted in different ways.

3. The intraluminal imaging catheter according to claim 2, wherein, The one or more values ​​in the second region and the one or more values ​​in the third region are encrypted based on the one or more values ​​in the first region.

4. The intraluminal imaging catheter according to claim 1, wherein, The one or more values ​​for the state of the intraluminal imaging catheter in the third region include: The unlock value represents the authorization to use the endoluminal imaging catheter when it is connected to the clinical console; The value in use represents the initial connection between the endoluminal imaging catheter and the clinical console; or The locked value represents the subsequent connection between the endoluminal imaging catheter and the clinical console.

5. The intraluminal imaging catheter according to claim 4, wherein, The one or more values ​​for the state of the intraluminal imaging catheter in the third region include: A permanently locked value, representing the connection between the intraluminal imaging catheter and the clinical console when the use of the intraluminal imaging catheter exceeds the maximum number of uses.

6. The intraluminal imaging catheter according to claim 1, wherein, The intraluminal imaging catheter also includes: The communication cable terminates at the connector, wherein the memory is disposed within the connector; and A handle configured to control at least one of the position or orientation of the ultrasonic transducer array within the body lumen, wherein the handle is coupled to the communication cable and the flexible elongated member, and The ultrasonic transducer array is configured for intracardiac echocardiography.

7. An intraluminal imaging system, comprising: The intraluminal imaging catheter according to any one of claims 1 to 6, and One or more processor circuits that communicate with the intraluminal imaging catheter and are configured to: Operate the ultrasonic transducer array to obtain the imaging data; and Write the following information into the non-volatile memory: The number of times the intraluminal imaging catheter can be used. The number of times the intraluminal imaging catheter has been used; and The state of the intraluminal imaging catheter. When the intraluminal imaging catheter is locked, or when the intraluminal imaging catheter has been used a number of times equal to or greater than the maximum number of uses, the one or more processor circuits will not operate the ultrasonic transducer array.

8. The intraluminal imaging system according to claim 7, wherein, The one or more processor circuits are configured to: When the intraluminal imaging catheter is being used within the lumen, its state is set to "in use". After the intraluminal imaging catheter has been used, its state is set to locked. The state of the intraluminal imaging catheter is set to unlocked during reprocessing of the intraluminal imaging catheter.

9. The intraluminal imaging system according to claim 7, wherein, The information written into the non-volatile memory by the one or more processor circuits also includes a checksum.

10. The intraluminal imaging system according to claim 7, wherein, At least a portion of the information written into the non-volatile memory by the one or more processor circuits is encrypted.

11. The intraluminal imaging system according to claim 7, in, The information written into the non-volatile memory by the one or more processor circuits further includes: The maximum duration of each use of the intraluminal imaging catheter; and A timestamp indicating the start time of use of the intraluminal imaging catheter. The one or more processor circuits include a timer, and Wherein, once the difference between the timer and the timestamp is equal to or exceeds the maximum duration, the one or more processor circuits are configured to change the state of the intraluminal imaging catheter to locked.

12. The intraluminal imaging system according to claim 11, wherein, When the endovascular imaging catheter is in use and the difference between the timer and the timestamp is less than the maximum duration, the endovascular imaging catheter is configured to repeatedly connect to and disconnect from the clinical workstation without triggering the one or more processor circuits to change the state of the endovascular imaging catheter from in use to locked.

13. An intraluminal imaging system, comprising: The intraluminal imaging catheter according to any one of claims 1 to 6, The memory includes A non-volatile memory configured to communicate with a manufacturer's workstation including a first processor circuit, a clinical workstation including a second processor circuit, and a reprocessor's workstation including a third processor circuit, such that: The manufacturer's workstation writes the unlock status value and the number of times the intraluminal imaging catheter can be used into the non-volatile memory. The clinical workstation operates the intraluminal imaging catheter and writes the following items into the non-volatile memory: A counter is used, which increments each time the intraluminal imaging catheter is operated; The status value in use, which replaces the unlocked status value when the intraluminal imaging catheter is being operated; and A locked state value replaces the in-use state value after a given time has elapsed since the intraluminal imaging catheter was first operated on. The reprocessor's workstation writes the unlocked status value into the intraluminal imaging catheter, replacing one or both of the in-use status value and the locked status value. The clinical workstation will not operate the endovascular imaging catheter if the locked state value is in the non-volatile memory, or if the usage counter contains a value greater than the number of times the endovascular imaging catheter can be used.

14. The intraluminal imaging system according to claim 13, wherein, The intraluminal imaging system also includes: The manufacturer's workstation.

15. The intraluminal imaging system according to claim 13, wherein, The intraluminal imaging system also includes: The clinical workstation.

16. The intraluminal imaging system according to claim 13, wherein, The intraluminal imaging system also includes: The reprocessor's workstation, wherein the reprocessor's workstation also includes a license status value selected from licensed or unlicensed.

17. The intraluminal imaging system according to claim 13, wherein, The intraluminal imaging system also includes: A remote server that communicates with the reprocessor's workstation, wherein the remote server is configured to be accessed via an application executed by the third processor circuitry of the reprocessor's workstation.

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