Systems and methods related to catheter-based procedures

Abstract

Methods and systems related to catheter-based procedures are provided. An aspect of the method of an embodiment of the present invention includes performing a catheter-based procedure and communicating data related to the catheter-based procedure to and / or from a catheter-based procedure information module. Also, an aspect of the system of an embodiment of the present invention includes a catheter-based procedure information module, a catheter-based system, and an operable connection between the catheter-based procedure information module and the catheter-based system, wherein the catheter-based procedure information module and the catheter-based system transmit and receive procedures and conditions for catheter-based treatment to and from each other.

Description

Technical Field

[0001] Cardiovascular tissue is prone to the accumulation of atherosclerotic plaques through a mechanism called atherosclerosis. The accumulation of atherosclerotic plaques is the accumulation of fatty and calcified substances that cause stenosis, narrowing of the arterial lumen, or heart valve insufficiency. Catheter-based procedures, such as deploying a catheter-based system, such as an angioplasty balloon, through a catheter, are important techniques for addressing such disease states in cardiovascular tissue or other tissues affected by disease states that cause narrowing of the lumen tissue.

[0002] Certain catheter-based procedures include, for example, deploying a catheter-based system configured to apply pulsatile energy to tissue, such as cardiovascular tissue, via a balloon. Such procedures and systems can be configured based on several different parameters, including, for example, the frequency of the pulsatile energy applied to the tissue, the amount of pressure applied to the tissue by the pulsatile energy, the number of pulses of pulsatile energy applied to the tissue, the duty cycle of applying pulsatile energy to the tissue, the duration of the treatment, an increase or decrease in frequency or pressure, the rate of such increase or decrease, synchronizing different aspects of the treatment to physiological conditions, such as the cardiac cycle, or alternating the application of pulsatile energy to the tissue with the application of static pressure to the tissue. Existing treatments, including such catheter-based procedures and systems, may rely exclusively on the operator's decision or judgment in connection with configuring such a procedure or system, and thus may lack the ability to easily and fully take into account past performance and past learning from similar or analogous catheter-based procedures performed, for example, at different treatment centers and / or on different subjects.

Summary of the Invention

[0003] Accordingly, there remains a need for improved configuration and control of catheter-based therapeutic procedures and methods of performing catheter-based procedures in connection with initiating treatment (i.e., automatically generating an initial configuration setting) or dynamically adjusting a treatment scenario (i.e., automatically generating a modified configuration setting for immediately adjusting settings during treatment based on feedback obtained during treatment in real-time or near real-time). For example, methods and systems for identifying and presenting for operator approval and / or correction (i.e., enabling an operator of a catheter-based system to accept an automatically generated configuration as presented, or alternatively, enabling the operator to adjust one or more aspects of the automatically generated configuration before applying such a configuration setting), the configuration settings of catheter-based procedures can improve the effectiveness of such procedures, including, for example, the effectiveness of such procedures among multiple different subjects at multiple different treatment sites. Further, such methods and systems can improve the safety of performing catheter-based procedures, for example, by terminating a catheter-based procedure before device or tissue damage occurs.

[0004] The methods and systems of the present invention can function to identify the configuration settings of catheter-based procedures by leveraging data regarding past catheter-based procedures such that subsequent catheter-based procedures are informed based on such past procedures. The methods and systems of the present invention can be configured to provide a centralized repository of such procedure-based data, such that catheter-based procedures occurring at multiple diverse locations for multiple diverse subjects can obtain access to the same extensive dataset of the historical results of catheter-based procedures. The methods and systems of the present invention can directly configure a catheter-based procedure or system based on automatically generated configuration settings, or can interface with an operator of a catheter-based system by, for example, proposing an initial or corrected configuration of the catheter-based procedure or system for approval or correction by the operator prior to application to the catheter-based procedure or catheter-based system.

[0005] Aspects of the method of embodiments of the present invention include performing a catheter-based procedure and communicating data regarding the catheter-based procedure to and / or from a catheter-based procedure information module. The catheter-based procedure information module may be a remote module. Also provided is a system comprising a first processor, the first processor comprising a memory operably coupled to the first processor, the memory including instructions stored thereon that, when executed by the first processor, cause the first processor to receive data regarding a catheter-based procedure from a catheter-based system and transmit data regarding the catheter-based procedure to the catheter-based system. The system of embodiments of the present invention also includes a catheter-based system, the catheter-based system comprising a catheter-based device and a second processor, the second processor comprising a memory operably coupled to the second processor, the memory including instructions stored therein that, when executed by the second processor, cause the second processor to transmit data regarding a catheter-based procedure to a catheter-based procedure information module, receive data regarding the catheter-based procedure from the catheter-based procedure information module, and configure the catheter-based device based at least in part on the data regarding the catheter-based procedure received from the catheter-based procedure information module. The system of embodiments of the present invention also includes an operable connection between the catheter-based procedure information module and the catheter-based system. Further provided is a non-transitory computer-readable storage medium configured to perform the methods described herein. The method, system, and non-transitory computer-readable storage medium are utilized in a variety of different applications including balloon angioplasty applications or other catheter-based procedures, therapies, or treatments.

Brief Description of the Drawings

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[0007] A method related to catheter-based treatment is provided. An aspect of the method of embodiments of the present invention includes performing a catheter-based treatment and communicating data related to the catheter-based treatment to and / or from a catheter-based treatment information module. The catheter-based treatment information module may be a remote module. Also, a system is provided, the system comprising a first processor, the first processor comprising a memory operably coupled to the first processor, the memory comprising instructions stored thereon, the instructions, when executed by the first processor, causing the first processor to receive data related to a catheter-based treatment from a catheter-based system and to transmit data related to the catheter-based treatment to the catheter-based system. The system of embodiments of the present invention also includes a catheter-based system, the catheter-based system comprising a catheter-based device and a second processor, the second processor comprising a memory operably coupled to the second processor, the memory comprising instructions stored therein, the instructions, when executed by the second processor, causing the second processor to transmit data related to a catheter-based treatment to a catheter-based treatment information module, to receive data related to the catheter-based treatment from the catheter-based treatment information module, and to configure the catheter-based device based at least in part on the data related to the catheter-based treatment received from the catheter-based treatment information module. The system of embodiments of the present invention also includes an operable connection between the catheter-based treatment information module and the catheter-based system. Further, a non-transitory computer-readable storage medium configured to implement the methods described herein is provided. The methods, systems, and non-transitory computer-readable storage media are utilized in a variety of different applications including balloon angioplasty applications or other catheter-based treatments, therapies, or procedures.

[0008] Before the present invention is described in detail, it should be understood that the present invention is not limited to the specific embodiments described, and thus can of course be modified. Also, since the scope of the present invention is limited only by the appended claims, it should also be understood that the terms used in this specification are for the purpose of describing specific embodiments only and are not intended to be limiting.

[0009] Where a range of values is provided, unless the context clearly dictates otherwise, each intermediate value between the upper and lower limits of that range, to one tenth of the unit of the lower limit, as well as any other stated value or intermediate value within the stated range of this description, is understood to be included in the present invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are likewise included in the present invention, subject to any specifically excluded limits in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the present invention.

[0010] In this specification, numerical values are preceded by the term "about" to present a specific range. The term "about" is used in this specification to provide literal support for the exact number that the term precedes, as well as for a number that is close to or approximates the number that the term precedes. When determining whether a number is close to or approximates a specifically listed number, the unlisted number that is close to or approximates may be a number that provides a substantial equivalent of the specifically listed number in the context in which it is presented.

[0011] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Any methods and materials similar or equivalent to those described in this specification may also be used in the practice or testing of the present invention, but representative, exemplary methods and materials are described below.

[0012] All publications and patents cited in this specification are hereby incorporated by reference as if each individual publication or patent was specifically and individually indicated to be incorporated by reference, and are incorporated by reference herein to disclose and describe the methods and / or materials for which they are cited in connection with those methods and / or materials. Any citation of a publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention has no right to antedate such publication on the basis of prior invention. Further, the provided publication dates may be different from the actual publication dates and may need to be individually verified.

[0013] Note that, as used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Further note that the claims may be drafted to exclude any optional element. Accordingly, this description is intended to serve as antecedent basis for use of exclusive terms, such as "solely" and "only" in connection with the recitation of claim elements, or for use of "negative" limitations.

[0014] As will be apparent to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with any of the features of some other embodiments without departing from the scope or spirit of the present invention. Any of the described methods may be performed in the order of events described or in any other logically possible order.

[0015] Devices and methods have been, or will be, described with functional descriptions for purposes of grammatical fluidity, but unless expressly recited under 35 U.S.C. § 112, claim terms should not necessarily be construed as limited by an interpretation of "means" or "step" limitations, but should be accorded the full scope of the meaning ascribed by the claim terms and equivalents thereof under the doctrine of equivalents, and it should be clearly understood that where claim terms are expressly recited under 35 U.S.C. § 112, full statutory equivalents under 35 U.S.C. § 112 should be accorded.

[0016] In further describing various aspects of the present invention, first, method embodiments will be described in more detail, followed by system embodiments, and a non-transitory computer-readable storage medium for implementing the subject method will be considered.

[0017] Method As summarized above, methods related to catheter-based procedures are provided. Embodiments of the methods of the present invention include performing a catheter-based procedure, communicating data related to the catheter-based procedure to a catheter-based procedure information module, and / or communicating data related to the catheter-based procedure from the catheter-based procedure information module. In an embodiment, the catheter-based procedure information module is a remote module. For example, the catheter-based procedure information module can be located in a different room, city, or country from where the catheter-based procedure is performed. In other embodiments, the data related to the catheter-based procedure communicated to and / or from the catheter-based procedure information module includes one or more of pre-treatment data, intra-treatment data, or post-treatment data, as described below.

[0018] The system of the present invention is used in a variety of applications, including angioplasty applications or other catheter-based therapies or treatments, such as the treatment of heart valve diseases. In some examples, the system is used to disrupt cardiovascular tissue, such as heart valve leaflets or commissures, or hardened deposits, such as calcium deposits, embedded within other cardiovascular tissue. Specifically, the methods of embodiments of the present invention are applied when performing subsequent catheter-based procedures, including, for example, catheter-based procedures on the same or different subjects at the same or different treatment sites, to better inform the configuration applied when performing the subsequent catheter-based procedure, including leveraging the results of previously performed catheter-based procedures. The present disclosure describes embodiments related to the treatment of tissue, such as cardiovascular tissue, related to calcification and / or deposits within the tissue, such as in a heart valve, or the characteristics thereof or calcification and / or deposits within cardiovascular tissue, such as tissue supporting the heart valve. However, the system and teachings are not limited to catheter-based procedures for addressing cardiovascular tissue in relation to cardiovascular tissue calcifications and can generally be applied to other uses determined by those skilled in the art.

[0019] This method can be used in connection with performing catheter-based procedures on any number of different subjects. In many embodiments, the subject is a "mammal" or "mammalian," terms used to broadly describe organisms within the class of mammals, including carnivores (e.g., dogs and cats), rodents (e.g., mice, guinea pigs, and rats), and primates (e.g., humans, chimpanzees, and monkeys). In some examples, the subject is a human.

[0020] Catheter-based treatment information module: Embodiments of the method of the present invention include communicating data related to a catheter-based procedure to a catheter-based procedure information module and / or communicating data related to a catheter-based procedure from a catheter-based procedure information module. Thus, in an embodiment, the catheter-based procedure information module may function in a manner similar to a controller, receive data related to a catheter-based procedure, and / or transmit a configuration or setting for performing a catheter-based procedure, such as a configuration or setting selected to automate a catheter-based procedure or improve the effectiveness of a catheter-based procedure.

[0021] In an embodiment, the catheter-based information module may comprise a processor having a memory configured to communicate data related to a catheter-based procedure. While no particular processor (or other computer hardware) is required to implement the present invention, nevertheless, the processor of interest may include a general-purpose processor, a graphics processing unit, a system-on-chip, a microcontroller, etc., such as those commercially available from AMD, ARM, Broadcom, Intel, Motorola, Nvidia, Qualcomm, Texas Instruments, etc. In some cases, the catheter-based information module may include a plurality of processors interconnected via an interconnect network, etc. The memory may be any suitable device, such as a magnetic, optical, or solid-state storage device (including a magnetic or optical disk, or tape, or RAM, or any other suitable device, either fixed or portable), in which the processor can store and retrieve data.

[0022] In an embodiment, any convenient means of communicating with and / or from a catheter-based treatment information module may be used. In some cases, the catheter-based treatment information module is operably connected to a catheter-based system for performing a catheter-based treatment. That is, the catheter-based treatment information module may be directly or indirectly coupled to a catheter-based system for performing a catheter-based treatment. In other cases, the catheter-based treatment information module and / or the catheter-based system for performing a catheter-based treatment may be configured to include any convenient communication interface. In some embodiments, the communication interface includes a receiver and / or a transmitter for communicating with a network and / or another device.

[0023] The communication interface may be configured for wired or wireless communication, including but not limited to radio frequency (RF) communication (e.g., radio frequency identification (RFID), Zigbee communication protocol, WiFi, infrared, wireless universal serial bus (USB), ultra-wideband (UWB), Bluetooth® communication protocol, and cellular communication such as code division multiple access (CDMA) or global system for mobile (GSM) communication for mobile communication). In some cases, the I2C communication protocol, i.e., the inter-integrated circuit communication protocol, may be used by the communication interface via a bus such as its serial bus. In some cases, the communication interface of interest may be a communication interface designed to reduce or minimize the number of wirings, such as the number of wirings between integrated circuits or the number of wirings of a catheter-based system for performing a catheter-based treatment.

[0024] In one embodiment, the communication interface is configured for data communication to and / or from an external device such as a catheter-based treatment information module and a catheter-based system for performing a catheter-based treatment or a computer terminal (e.g., a computer terminal in a control room) for similar complementary data communication, and includes one or more communication ports such as physical ports or interfaces such as a USB port, an RS-232 port, or any other suitable electrical connection port.

[0025] In one embodiment, the communication interface is configured for infrared communication, Bluetooth® communication, or any other suitable wireless communication protocol to enable the catheter-based treatment information module to communicate with other devices such as a catheter-based system for performing a catheter-based treatment, a computer terminal and / or network, a communicable mobile phone, a personal digital assistant, or any other communication device that can be used in conjunction with the catheter-based treatment information module.

[0026] In one embodiment, the communication interface is configured to provide a connection for data transfer using the Internet Protocol (IP) via a mobile phone network, Short Message Service (SMS), a wireless connection to a personal computer (PC) on a local area network (LAN) connected to the Internet, or a WiFi connection to the Internet at a WiFi hotspot.

[0027] In one embodiment, the catheter-based treatment information module is configured to wirelessly communicate with a server device via a communication interface using a common standard such as, for example, the 802.11 or Bluetooth® RF protocol, or the IrDA infrared protocol. Such a server device can be a portable device such as a smartphone, a personal digital assistant (PDA), or a notebook computer, or a larger device such as a desktop computer, an appliance, etc. In some embodiments, the server device has a display such as a liquid crystal display (LCD), and input devices such as buttons, a keyboard, a mouse, or a touch screen.

[0028] In some embodiments, the communication interface is configured to automatically or semi-automatically communicate data stored within the catheter-based treatment information module, for example, within an optional data storage unit, with a network or a server device using one or more of the communication protocols and / or mechanisms described above.

[0029] In an embodiment, the catheter-based treatment information module is a remote module. The term "remote module" means that the catheter-based treatment information module is separated by a distance from the location where the catheter-based treatment is performed. That is, the catheter-based information module can be separated from the catheter-based treatment, i.e., the catheter device involved in performing a separate physical and / or logical device. For example, the catheter-based treatment information module can be a module separate from the catheter device (catheter-based system) used in connection with the performance of the catheter-based treatment, and the catheter-based treatment information module can be located, for example, in a different part of the treatment room or procedure room where the catheter-based treatment is performed, such as a different compartment, beyond the sterile field or behind a barrier such as a curtain or lead shield. In other examples, the catheter-based treatment information module can be located in a different room of the same building, such as a control room of a hospital or treatment center. In other cases, the catheter-based treatment information module can be located in a different building or city or country from the location where the catheter-based treatment is performed, i.e., at any convenient distance as required by, for example, the constraints and / or configuration of the catheter-based treatment information module and the catheter-based treatment.

[0030] In an embodiment, the catheter-based treatment information module is configured to store data related to catheter-based treatment. The catheter-based treatment information module can be configured to store any data related to catheter-based treatment, such as pre-treatment data, during-treatment data, and post-treatment data, as described herein. Such data can be stored in a manner or format that enables the data to be easily accessible, for example, for analysis or as input to an algorithm, such as an artificial intelligence algorithm, for example, a machine learning algorithm or a neural network algorithm or a deep learning algorithm or a convolutional neural network algorithm, and is configured to generate settings and / or configurations for catheter-based treatment, as described herein. Such data can be stored in a database format or other data structure format, or in a manner or format that facilitates such analysis, such that data related to different catheter-based treatments is stored in a uniform and / or predictable manner that can be accessed immediately as needed. For example, data related to catheter-based treatment can be stored in a manner (such as stored in distributed storage or cloud-based storage, etc.) that enables such data to be accessed by different catheter-based treatment information modules, for example, different catheter-based treatment information modules existing in different control rooms of different treatment centers.

[0031] In some embodiments, the memory of the catheter-based treatment information module can be configured to store such data, and / or the catheter-based treatment information module can be configured to store such data in a separate external storage, including, for example, storing in an external storage attached via a network connection such as distributed data storage or cloud-based storage. That is, the data is stored in multiple nodes of a computer network and / or is distributed across physically separated storage devices, including physically separated storage devices at separate locations interconnected, for example, via a computer network, in a logically continuous manner. Any convenient distributed data storage and / or cloud-based storage technology can be applied, including, for example, commercially available cloud-based storage such as cloud storage services available from Amazon, Box, Dropbox, Google, or Microsoft. In an embodiment, the data storage including network-based external storage and / or cloud-based storage can be configured to comply with applicable security and privacy-related laws, regulations, rules, standards, and best practices, such as the Health Insurance Portability and Accountability Act (HIPPA) of 1996 related to the storage of medical data in the United States.

[0032] In some embodiments, the catheter-based treatment information module can be configured to receive and / or transmit data regarding a plurality of catheter-based treatments. In some cases, the catheter-based treatment information module can be configured to receive and / or transmit data regarding a first catheter-based treatment at a first time and a second catheter-based treatment at a second time. Thus, the catheter-based treatment information module can be configured to receive and / or transmit data regarding catheter-based treatments occurring over any desired period, such as treatments occurring over a period of one day or more, such as over a period of one month or more or one year or more.

[0033] In other cases, the catheter-based treatment information module can be operably connected to a plurality of catheter-based systems, i.e., systems for performing catheter-based treatment, via, for example, a computer network as described above. In such a case, the catheter-based treatment information module can receive and / or transmit data regarding two or more catheter-based treatments substantially simultaneously. In an embodiment, different catheter-based treatments are performed at different locations, i.e., different treatment locations such as different treatment rooms or procedure rooms in a treatment center or hospital, or different buildings such as different treatment centers or different hospitals, or different cities or different countries.

[0034] In an embodiment, the catheter-based treatment information module is configured to receive, store, and / or analyze data regarding any convenient number of catheter-based treatments (i.e., data derived from any number of catheter-based treatments), as desired, for example, one or more, for example, 10 or more, such as 100 or more, such as 1,000 or more, such as 10,000 or more, such as 100,000 or more catheter-based treatments.

[0035] Catheter-based treatment data: In an embodiment, the data regarding catheter-based treatment communicated to the catheter-based treatment information module and / or the data regarding catheter-based treatment communicated from the catheter-based treatment information module includes any available data related to the catheter-based treatment and can vary as desired. In some cases, the data regarding catheter-based treatment is, for example, data related to generating configuration settings for subsequent catheter-based treatments, such as the catheter-based treatment or subsequent catheter-based treatments performed on different subjects, and / or for analyzing the effectiveness of such catheter-based treatments.

[0036] In some embodiments, the data related to catheter-based treatment communicated to the catheter-based treatment information module and / or the data related to catheter-based treatment communicated from the catheter-based treatment information module includes pre-treatment data or during-treatment data or post-treatment data. "Pre-treatment data" refers to information available before performing a catheter-based treatment, "during-treatment information" refers to information available during a catheter-based treatment, i.e., data available while performing a catheter-based treatment, and "post-treatment data" refers to information available after performing a catheter-based treatment. Thus, in an embodiment, the pre-treatment data communicated to and / or from the catheter-based treatment information module includes data collected before performing a catheter-based treatment, the during-treatment data communicated to and / or from the catheter-based treatment information module includes data collected during a catheter-based treatment, and the post-treatment data communicated to and / or from the catheter-based treatment information module includes data collected after performing a catheter-based treatment.

[0037] Data related to catheter-based treatments communicated to a catheter-based treatment information module and / or data related to catheter-based treatments communicated from a catheter-based treatment information module may include imaging data such as pre-treatment imaging, intra-treatment imaging, and / or post-treatment imaging. Imaging data such as pre-treatment imaging, intra-treatment imaging, and / or post-treatment imaging may include images showing one or more characteristics of the tissue in which the catheter-based treatment is being performed. Such characteristics may include characteristics of diseased tissue, such as the presence, location, or extent of calcium deposits within cardiovascular tissue, such as cardiac valve commissure or leaflet calcification, or other atherosclerotic tissue such as occlusion within a lumen tissue such as a stenotic artery with chronic total occlusion. In embodiments, imaging data such as pre-treatment imaging, intra-treatment imaging, and / or post-treatment imaging may include the results of any convenient imaging technique, and such imaging data may vary, for example, as angiographic imaging, computed tomography imaging, optical coherence tomography, intravascular ultrasound imaging, cardiac echo imaging, and the like. In other embodiments, the imaging data is titled "Systems and Methods for Treating Cardiovascular Tissue", filed on the same day as this specification (Attorney Docket No.: AVSI-004PRV), and the disclosure of which is incorporated herein by reference, and is described in U.S. Patent Application No. 63346703, and includes images of aspects of a system for performing catheter-based treatment, such as an image of a catheter balloon present in a lumen tissue or a cardiac tissue conforming element present in a cardiac valve. In some cases, the imaging data includes, for example, an annotated image of the tissue, such as an annotation indicating the location or extent of a lesion, such as an image of a catheter near cardiovascular tissue, such as an image of a balloon attached to a cardiac valve having calcium deposits on the leaflet, and / or an annotated image of a component used in connection with a catheter-based treatment, and / or an annotated image such as an image of a balloon attached to a catheter near cardiovascular tissue.

[0038] Data related to catheter-based procedures communicated to the catheter-based procedure information module, and / or data related to catheter-based procedures communicated from the catheter-based procedure information module may also include vital signs such as pre-treatment vital signs, during-treatment vital signs, or post-treatment vital signs. Vital signs such as pre-treatment vital signs, during-treatment vital signs, or post-treatment vital signs may include any available physiological characteristics of the subject, and such vital signs may vary, for example, according to the nature of the diseased tissue, the subject's baseline condition, or the catheter-based procedure. The target vital signs include body temperature, heart rate, and / or respiratory rate. Vital signs may also include other physiological characteristics such as blood pressure measurements including systolic and / or diastolic measurements, blood oxygenation measurements (i.e., pulse oximeter readings), height or weight measurements, body composition information, the distance between the catheter entry point (e.g., the catheter entry point via the femoral artery) and the treatment site (e.g., the aortic heart valve), and other measurements such as other measurements.

[0039] Data related to catheter-based procedures communicated to the catheter-based procedure information module, and / or data related to catheter-based procedures communicated from the catheter-based procedure information module may also include other measurements such as pre-treatment measurements, during-treatment measurements, and / or post-treatment measurements. For example, such measurements may include the results of ventricular pressure, aortic pressure, electrocardiogram, or blood volume measurements, or measurements of blood perfusion, for example, perfusion through the lumen tissue across an occlusion such as arterial stenosis.

[0040] Data regarding a catheter-based procedure communicated to a catheter-based procedure information module, and / or data regarding a catheter-based procedure communicated from a catheter-based procedure information module, may also include catheter system sensor data. Catheter system sensor data may include data collected via aspects of the catheter system used in connection with the performance of a catheter-based procedure. In embodiments, catheter system sensor data may include data collected from sensors attached to or integrated with such a catheter system. In some cases, catheter system sensor data may include pressure measurements such as catheter or balloon pressure, or volume measurements such as changes in fluid volume. For example, catheter system sensor data may include balloon position, balloon deployment rate, valve opening amount, valve eccentricity, perivalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure, or the position of the valve within the valve annulus.

[0041] Data related to catheter-based procedures communicated to a catheter-based treatment information module, and / or data related to catheter-based procedures communicated from a catheter-based treatment information module, may also include outcome information. Outcome information may refer to the outcome of a catheter-based procedure and, in each case upon completion of the catheter-based procedure, may include any aspect of an outcome or result, such as a change resulting as a consequence of tissue characteristics, e.g., a post-treatment extensibility measurement or a post-treatment measure of cardiac valve function. In embodiments, outcome information includes data related to acute valve orifice, valve extensibility (or other extensibility metrics based on measurements of pressure and volume changes, e.g., vascular extensibility), intravascular or external pressure. In some cases, the associated pressure data includes, for example, blood pressure measurements via a blood pressure cuff for measuring systolic and diastolic pressures, or a ratio of blood pressure measurements obtained via a blood pressure cuff from a subject's leg region (e.g., ankle) and arm region. In other cases, the associated pressure data includes pressure measurements obtained within the coronary artery and aorta or left ventricle, and includes appropriate ratios of various pressures, e.g., diastolic pressure gradient, non-wave instantaneous diastolic pressure gradient, or coronary flow reserve ratio. Outcome information may include data collected from aspects of a catheter system used to perform a catheter-based procedure, such as, for example, a pressure or volume sensor integrated into the catheter system, e.g., a volume sensor integrated into a connector of the catheter system (such as a Hall sensor and a magnet configured to measure changes in fluid volume). In other cases, outcome information may include data collected from sensors that are separate from and external to the catheter system used to perform the catheter-based procedure, such as, for example, imaging results or electrocardiogram results or cardiac echo results or metrics of fluid perfusion in a particular tissue region. In embodiments, such sensors may be invasive or non-invasive. In some cases, outcome information may include data collected from a mechanism configured to measure pressure across a lesion, such as, for example, measurements obtained via a wire attached to the distal region of a catheter configured to measure proximal and distal pressures across the lesion. In other cases, outcome information may include fractional flow reserve (FFR) data.In an embodiment configured to treat the aortic valve, outcome information may be obtained using a pressure sensor (e.g., a catheter balloon present within a blood vessel) configured to measure pressure across a treatment zone. In an embodiment, the sensor used to obtain outcome information may include an optical fiber wire attached to the distal region of a catheter. In yet other embodiments, the outcome information may include data collected via an ultrasound or magnetic resonance imaging (MRI) or optical imaging system configured to indicate a change in the position of a heart structure or heart function or flow.

[0042] Data regarding a catheter-based procedure that is pre-treatment data, such as pre-treatment imaging or pre-treatment vital signs or pre-treatment measurements, may include pre-treatment data collected, for example, as part of a pre-operative workup of a subject performed on the day of the catheter-based procedure or substantially immediately prior to performing the catheter-based procedure, or data obtained more than one day prior to performing the catheter-based procedure, such as the results of an echocardiogram obtained at an earlier time at a separate, specific treatment site, i.e., data available prior to performing the catheter-based procedure.

[0043] Data regarding a catheter-based procedure that is intra-treatment data, such as intra-treatment imaging or intra-treatment vital signs or intra-treatment measurements, may include data available at any point during the catheter-based procedure, for example, data substantially collected when the catheter-based procedure is initiated, such as when treatment is first applied via the catheter-based procedure, or later when treatment is continued via the catheter-based procedure. Examples of intra-treatment data include imaging data collected at regular intervals throughout a catheter-based procedure depicting the location or orientation of aspects of the catheter-based system used in the catheter-based procedure, or measurements of tissue extensibility, i.e., measurements of tissue extensibility indicating the degree of disruption of calcium deposits, collected at regular intervals throughout the catheter-based procedure or at the occurrence of a specific event (e.g., a change in pressure or volume exceeding a specific threshold).

[0044] Data regarding catheter-based procedures that are post-treatment data, such as post-treatment imaging, post-treatment vital signs, or post-treatment measurements, can include data that is available at any time after the completion of the catheter-based procedure, for example, immediately after the catheter-based procedure has ended, such as immediately after treatment has ceased being applied via the catheter-based procedure, or more than 1 minute, more than 1 hour, more than 1 day, more than 1 week, etc. after the catheter-based procedure has been completed. Examples of post-treatment data include imaging data collected at regular intervals depicting the position or orientation of aspects of the catheter-based system used in the catheter-based procedure, or measurements of tissue extensibility, i.e., measurements of tissue extensibility indicating the degree of destruction of calcium deposits in each instance collected at regular intervals throughout the catheter-based procedure, or other measurements intended to measure aspects of the subject's physiological function that are affected by the disease state.

[0045] Composition of catheter-based procedures: The method according to the present invention may further include configuring a catheter-based treatment based at least in part on data communicated to and / or from a catheter-based treatment information module. For example, the catheter-based treatment information module can communicate, i.e., transmit, settings to a catheter system used in connection with performing a catheter-based treatment, and the settings reflect a particular configuration of the catheter system for applying the catheter-based treatment in a particular manner. Any potential settings or configurations can include, but are not limited to, catheter balloon pressures such as maximum pressure, balloon inflation frequency or duty cycle, total treatment time, total number of balloon pulses, specifications of changes, i.e., changes over time in any configuration (e.g., a configuration in which the catheter balloon pressure increases over time at a specified rate before decreasing at a specified rate over time), etc., that can be transmitted from the catheter-based treatment information module. In other cases, potential settings or configurations can include settings related to the hardware type, such as what type (e.g., size or other features or characteristics) of catheter balloon or distal crossing unit or heart tissue conforming element or catheter should be applied when performing a catheter-based treatment, or other aspects of the catheter-based system for use when performing a catheter-based treatment. That is, the configuration or settings communicated from the catheter-based treatment information module can include at least specifications of aspects of the catheter system used to perform the catheter-based treatment, as well as settings for how to operate or control or manipulate such a catheter system in connection with performing the catheter-based treatment.

[0046] In an embodiment, by "constructing a catheter-based treatment based at least in part on data communicated to and / or from a catheter-based treatment information module", it is meant that the catheter-based information module is configured to first receive information regarding a catheter-based treatment and, based on such information, communicate information regarding constructing a catheter-based treatment. For example, the catheter-based treatment information module may receive information indicating that a catheter-based treatment is to be performed to address a heart valve having a disease with specific tissue characteristics, and the catheter-based information module may transmit a configuration (i.e., a configuration setting) that includes applying pulsatile energy to a diseased tissue at a specific frequency and / or duty cycle and / or duration (e.g., time or total number of pulses) such that the catheter-based treatment is constructed at least in part based on such a configuration generated and received by the catheter-based information module. Continuing with such an example, the catheter-based treatment information module may subsequently receive information indicating a change in tissue extensibility (e.g., heart valve extensibility), and the catheter-based information module may transmit a further, i.e., revised or updated, configuration setting that includes applying pulsatile energy to the diseased tissue at a different specified frequency and / or pressure and / or duty cycle and / or duration (e.g., time or total number of pulses) or other settings such that the catheter-based treatment is reconfigured at least in part based on such a subsequent configuration from the catheter-based information module. In some cases, information regarding perfusion beyond an aspect of the catheter-based system used to perform a catheter-based treatment (e.g., an angioplasty balloon or a heart tissue conforming element) may be communicated to and / or from the catheter-based information module, and as a result, a revised treatment plan may relate to improving perfusion beyond such an aspect of the catheter-based system, e.g., preventing tissue damage resulting from a decrease in perfusion beyond the catheter-based system.

[0047] The catheter-based information module of an embodiment of the present invention can be configured to generate a treatment plan. In an embodiment, the catheter-based treatment information module is configured to implement a treatment plan generation algorithm. In some cases, the treatment plan generation algorithm is configured to generate a treatment plan based at least in part on data related to a catheter-based treatment communicated to the catheter-based treatment information module. In other cases, the data communicated from the catheter-based treatment information module includes a treatment plan.

[0048] "Treatment plan" means any potential configuration related to the implementation of a catheter-based treatment, i.e., setting any configurable aspect of the implementation of a catheter-based treatment. In an embodiment, the treatment plan includes one or more configurations, i.e., settings, for a catheter system for implementing a catheter-based treatment. For example, the treatment plan may specify a device type such as a catheter device capable of delivering pulsatile energy, e.g., a device capable of delivering high volume, low frequency, and low pressure pulses, or a device capable of delivering low volume, high frequency, and high pressure pulses. In other examples, the treatment plan may specify a balloon type, e.g., the size or shape of a catheter balloon, or the degree of expansion volume or stretchability, or similar aspects of other related devices, e.g., the type of heart tissue conforming element (e.g., the aspect of a catheter system configured to deliver pulsatile energy to a heart valve such as a heart valve commissure or cusp), or a distal crossing unit (e.g., the aspect of a catheter system configured to cross a chronic total occlusion). In other cases, the treatment plan may specify other aspects of a catheter system for implementing a catheter-based treatment, such as specifying a potential source, e.g., a potential source containing pressurized carbon dioxide, or specifying an oscillator type, e.g., an oscillator configured to generate pressure oscillations at a specific frequency, or specifying a connector type, e.g., a connector configured to convert a first pulse energy into a second pulse energy at a specific fluid displacement amount.

[0049] In other embodiments, the treatment plan includes the configuration of a catheter-based treatment. That is, in some cases, the treatment plan may specify how the catheter system is to be used to perform a catheter-based treatment. In some cases, the configuration of the catheter-based treatment includes the treatment type, treatment duration, treatment intensity, or treatment frequency. The treatment type may include any desired catheter-based treatment, such as the application of pulsatile energy using a balloon catheter system, or the application of pulsatile energy to a heart valve using a heart tissue conforming element. Other examples of treatment types include static energy, such as applying a static pressure to tissue, or any desired combination of static and dynamic energy, such as a combination of static and pulsatile pressure. Still other examples of treatment types include, for example, forms of electrical impulses such that cavitation bubbles, ultrasound, plasma bubbles or other high-pressure impulses are generated, or forms of optical pulses or laser pulses such that cavitation bubbles, ultrasound, plasma bubbles or other high-pressure impulses are generated, or forms of thermal energy or energy for cryotherapy, i.e., energy that applies heat or cooling to tissue, including other treatments performed using catheter-based treatments known in the art that involve applying energy to tissue. The treatment intensity may include any desired characteristic of how the treatment type is applied, such as, for example, the pressure applied via pulsatile energy, or a duration such as the total time for which pulsatile energy is applied. The treatment frequency may include the pulse frequency or duty cycle at which pulsatile energy is applied.

[0050] In some cases, the treatment plan may relate to the manner of a device deployed or implanted in tissue, such as a stent (i.e., it may be at least partially based on and / or may provide guidance such as configuration settings). The treatment plan information relates to the deployment of the stent within the relevant tissue, the behavior of the stent present within the relevant tissue, the response of the stent within the relevant tissue, the response of the relevant tissue to the placement of the stent, and / or the orientation of the stent within the relevant tissue. In other embodiments, a catheter-based procedure may include implanting a replacement heart valve, such as an artificial heart valve or a donor heart valve. In such embodiments, the treatment plan may include guidance intended to affect and / or predict the desired behavior of a device, such as the implanted device. For example, in the case of a catheter-based procedure to deploy a stent, the treatment plan information may relate to predictions regarding how such a stent will respond upon deployment, such as whether the stent will jump forward when using a self-expanding stent, or how the stent and the vascular tortuosity will respond when the stent is deployed, or whether the stent will cause edge dissociation, or whether the stent will fully expand, or whether the blood vessel will require more preparation. In the case of a catheter-based procedure to deploy a replacement heart valve, the treatment plan information may relate to predictions regarding how the replacement heart valve will seat and function.

[0051] In some cases, the goal of a catheter-based treatment, and thus the corresponding treatment plan for such a catheter-based treatment, is, for example, to apply a specific peak pulsatile force to the tissue surrounding a balloon or a heart tissue conforming element involved in the implementation of the catheter-based treatment. Such pulsatile forces can vary, for example, based on stenosis locations and radial calcium locations within the tissue. The smaller the diameter of the tissue, the greater the force and the lower the pressure / energy that needs to be applied for the same effect. For tissue being treated, such as calcium located far from the center of the lumen, higher pressures are required to achieve the same force and stress within the calcium. In embodiments, it is desirable to measure this diameter in situ via volume / diameter measurements (i.e., measurements via a balloon), optical coherence tomography (OCT), or other imaging techniques such as ultrasonic imaging or fluoroscopic imaging or other external imaging techniques. After measurement, a peak pressure is applied, and then a treatment plan can be developed based at least in part on such measurements such that the force / energy applied to the calcium, for example, via a balloon or a heart tissue conforming element, is adjusted during the implementation of the catheter-based treatment to be consistent. Such examples illustrate how embodiments of the present invention can be used to improve the safety of treatment, i.e., to improve the safety of performing a catheter-based treatment. For example, embodiments of the present invention include providing guidance and / or determining and / or controlling when to terminate a treatment. In some embodiments, a catheter-based treatment information module or a controller of a catheter-based system can monitor the catheter-based treatment and can terminate such a treatment. For example, an embodiment can stop a catheter-based treatment if a catheter-based treatment information module or a controller of a catheter-based system determines that the balloon of the catheter-based system is likely to rupture.In some cases, the embodiment is configured to reduce pressure, e.g., pressure applied to a balloon of a catheter-based procedure or a heart tissue conforming element, prior to calcium disruption to minimize tissue damage when not in contact with calcium.

[0052] In an embodiment, the treatment plan generation algorithm can be configured to generate a treatment plan, i.e., a configuration setting for performing a catheter-based treatment, in any convenient manner, and such configuration settings can be changed. For example, the treatment plan generation algorithm can include a lookup algorithm that accesses, e.g., queries, a database based on any relevant aspect of the catheter-based treatment, such as measurements of lumen thickness or the presence of calcification. In some embodiments, the treatment plan generation algorithm is configured to compare at least a subset of data related to the catheter-based treatment with data from previous catheter-based treatments. That is, the catheter-based information module can receive information related to the catheter-based treatment, such as, for example, characteristics of the diseased tissue (e.g., tissue extensibility), or measurements of the acute valve opening, or the age or blood pressure measurements of the subject undergoing the catheter-based treatment, and the treatment plan generation algorithm can compare at least a subset of such received information with data from previously performed catheter-based treatments. For example, the treatment plan generation algorithm can compare at least a subset of such received information with similar data from previously performed catheter-based treatments to examine previously applied configurations or settings. In some embodiments, the treatment plan generation algorithm is configured to access a set of data related to a plurality of previous catheter-based treatments. Such a set of data can include data received by the catheter-based information module related to the catheter-based treatment, as well as the configuration settings applied to the previously performed catheter-based treatments. Such a set of data can be organized such that data received by the catheter-based information module related to the catheter-based treatment (e.g., data including measurements of tissue extensibility or imaging data or evaluation of the diseased tissue, etc.) can function as a key or index for accessing the corresponding configuration data of the corresponding catheter-based treatment.In such an embodiment, the treatment planning algorithm can be configured to search for previously used configuration data using at least a subset of data related to catheter-based procedures. Embodiments that utilize such a configuration can reapply the configuration for a catheter-based procedure that was successful in a previously performed catheter-based procedure.

[0053] In some cases, the embodiment can include a treatment planning algorithm configured to extrapolate relevant configuration data if the data received by the catheter-based information module is not identical to the data available in the set of data related to a plurality of previous catheter-based procedures. A method based on any convenient extrapolation, such as linear extrapolation, can be applied. For example, if a data measurement (e.g., a tissue extensibility measurement) collected in relation to a predicted or ongoing catheter-based procedure is at an intermediate point between the tissue extensibility measurements of two previously performed catheter-based procedures, the treatment planning algorithm can generate a configuration setting for the predicted or ongoing catheter-based procedure that reflects an intermediate point between the corresponding settings of the two previously performed catheter-based procedures.

[0054] In an embodiment, the treatment plan generation algorithm may be configured to utilize a non-linear method for generating a treatment plan for catheter-based treatment. In some cases, the treatment plan generation algorithm includes a machine learning algorithm. That is, in an embodiment, the treatment plan algorithm may receive information regarding catheter-based treatment, and at least a subset of that information may include an input to a machine learning algorithm configured to generate a treatment plan. A "machine learning" algorithm means a convenient computer algorithm designed to automatically learn through experience. In an embodiment, the relevant machine learning algorithm may generate a treatment plan using a supervised learning, unsupervised learning, or reinforcement learning approach. The relevant machine learning algorithm may reach a treatment plan using regression and classification techniques. In an embodiment, the relevant experience used to train such a learning algorithm may include, for example, specifically constructed training data or previously collected configurations (i.e., configuration settings) and / or data (i.e., tissue stretchability measurements or outcome information). That is, the training data may include any amount of available pre-treatment data, during-treatment data, and / or post-treatment data from any catheter-based treatment, such as one or more previously performed catheter-based treatments. In some cases, the machine learning algorithm includes a statistical model, a tree-based model, a deep learning model, an artificial neural network, a convolutional neural network, a deep learning model, etc., and such models and algorithms are known in the art. In other cases, for example, a Gaussian algorithm such as a Gaussian differential filtering algorithm is applied to detect changes, such as changes in measurements transmitted to a catheter-based treatment information module, and to set thresholds for occurrences, such as occurrences of measurements exceeding a threshold value. Such an algorithm is described in detail, for example, in U.S. Patent No. 11,464,949B2, the disclosure of which is incorporated herein by reference.

[0055] Embodiments of a method in which a treatment planning algorithm includes a machine learning algorithm may further include training the machine learning algorithm with data regarding catheter-based treatments. In some cases, data regarding one or more previously performed catheter-based treatments may be used to train the machine learning algorithm. For example, tissue characteristics (e.g., initial or intermediate valve extensibility) and / or outcome information (e.g., resulting valve extensibility), and corresponding treatment plans, i.e., configuration settings (e.g., device type or pulsatile energy pressure, frequency, duty cycle or treatment duration (i.e., the duration or total number of balloon pulses applied to the tissue)) may be provided to the machine learning algorithm for training the machine learning algorithm to make predictions regarding optimal or effective treatment plans. In an embodiment, the data used to train the machine learning algorithm may include data from a plurality of previous catheter-based treatments. In some embodiments, such training data, i.e., data regarding previous catheter-based treatments, may include data from catheter-based treatments performed at a plurality of different locations including 2, 3, 4, 5, 6, 7, 8, 9, 10, 100, 1000, 10000, or more different locations. That is, the catheter-based information module may be interconnected, for example, to receive data regarding catheter-based treatments from a plurality of different locations. For example, the catheter-based information module may be configured at a plurality of different treatment locations such as different treatment locations within a treatment center or different treatment centers such as a plurality of hospitals, and may be interconnected, for example. In an embodiment, such training data, i.e., data regarding previous catheter-based treatments, may include data from catheter-based treatments performed on one or more different subjects including 2, 3, 4, 5, 6, 7, 8, 9, 10, 100, 1000, 10000, or more different subjects. In other cases, synthetic data, i.e., data generated by catheter-based treatments other than data generated by previously performed catheter-based treatments, may be used to train the machine learning algorithm.Such synthetic data can be generated in any convenient manner, and such data can be modified.

[0056] Application of a treatment plan: Embodiments of the method according to the present invention further include constituting a catheter-based treatment at least partially based on a treatment plan. That is, in an embodiment, the treatment plan includes settings or configurations for performing a catheter-based treatment. Constituting a catheter-based treatment plan includes applying such settings or configurations in relation to performing a catheter-based treatment. For example, the treatment plan may include a frequency setting for applying pulsatile energy to tissue. In such an example, applying such a treatment plan includes applying pulsatile energy to the tissue at the frequency setting specified in the treatment plan. In some cases, constituting a catheter-based treatment includes applying an initial configuration for the catheter-based treatment. That is, the treatment plan may specify one or more configurations or settings in which a catheter-based treatment can first be performed. Such settings for a catheter-based treatment can be maintained as such during the course of the catheter-based treatment, or modified based on information obtained thereafter, such as a response caused by the catheter-based treatment, such as a change in tissue extensibility (or, in some cases, the absence of an expected change) when the treatment plan was first applied when performing the catheter-based treatment.

[0057] In some cases, configuring a catheter-based procedure can include reconfiguring the catheter-based procedure while the catheter-based procedure is being performed. That is, the treatment plan can specify one or more configurations or settings in which the catheter-based procedure can be performed after the catheter-based procedure has been initiated. In some cases, the initial treatment plan specifies a first set of configuration settings that are applied when initiating the catheter-based treatment, and subsequent treatment plans specify a second set of configuration settings that are applied while the catheter-based procedure is being performed. For example, the configuration for a catheter-based procedure can be changed or updated based on information obtained after initiating the catheter-based procedure, such as a response caused by the catheter-based procedure, such as a change in tissue extensibility (or the absence of an expected change) after initially applying the initial treatment plan when performing the catheter-based procedure.

[0058] In embodiments, configuring a catheter-based treatment may include, for example, selecting a treatment type, treatment duration, treatment intensity, or treatment frequency. Such configuration may be applied with respect to an initial configuration or a subsequent reconfiguration of a catheter-based treatment. In some embodiments, the treatment type may include any desired catheter-based treatment, for example, application of pulsatile energy using a balloon catheter system, or application of pulsatile energy to a heart valve using a heart tissue conforming element, or application of pulsatile energy to a chronic total occlusion using a distal crosser unit. Other examples of treatment types include static energy, for example, applying a static pressure to tissue, or any desired combination of static and dynamic energies, for example, a combination of static and pulsatile pressures. Still other examples of treatment types include, for example, forms of electrical impulses such that cavitation bubbles, ultrasound, plasma bubbles or other high-pressure impulses are generated, or forms of optical or laser pulses such that cavitation bubbles, ultrasound, plasma bubbles or other high-pressure impulses are generated, or applying energy to tissue in the form of thermal energy or, for example, energy for cryotherapy, i.e., energy that applies heat or cooling to tissue, including other treatments implemented using catheter-based treatments known in the art.

[0059] In embodiments, the treatment duration includes the amount of time that the treatment is applied to tissue. In an example, the treatment duration specifies the total treatment time and / or the amount of time that different aspects of the treatment are applied to tissue. For example, in some cases, the treatment duration specifies the amount of time that static energy is applied to tissue, and / or the amount of time that the tissue is allowed to rest, and / or the amount of time that pulsatile energy is applied to tissue. In some cases, the treatment duration includes one or more specific times corresponding to the duration of one or more aspects of the treatment or a range of potential treatment durations, for example, a minimum and / or maximum treatment duration. In other cases, the treatment duration includes, for example, the number of pulses applied from a balloon to tissue.

[0060] In an embodiment, treatment intensity includes a measure of the intensity of treatment applied to tissue. For example, if the treatment includes applying pulsatile energy or static energy to tissue, the treatment intensity is such a measure of the static or pulsatile energy applied to the tissue, such as the amplitude or magnitude of the treatment energy, or another measure of the intensity of the energy so applied to the tissue, for example, the root mean square measure of the intensity of the pulsatile energy applied to the tissue, which is known in the art. In other cases, the treatment intensity includes the minimum amount and / or maximum amount of energy applied to the tissue. For example, in an embodiment where pulsatile pressure is applied to tissue, the treatment intensity may include the minimum and maximum amounts of pressure applied to the tissue. By way of example, the treatment intensity includes the overall treatment intensity and / or the treatment intensity corresponding to an aspect of the treatment. In some cases, the treatment intensity includes one or more specific intensity values corresponding to the intensity of one or more aspects of the treatment or the range of potential treatment intensities, for example, the minimum and / or maximum treatment intensity.

[0061] In an embodiment, treatment frequency includes the frequency and / or duty cycle at which the treatment is applied. In some embodiments where a catheter-based treatment includes applying pulsatile energy, for example, to cardiovascular tissue such as a heart valve, or to tissue such as a stenosed artery or chronic total occlusion, the treatment frequency includes the frequency at which the pulsatile energy is applied to the tissue and / or the duty cycle for applying the pulsatile energy to the tissue. In some cases, the treatment frequency includes one or more specific frequency and / or duty cycle values corresponding to the frequency and / or duty cycle of one or more aspects of the treatment or the range of potential treatment frequencies and / or duty cycles, for example, the minimum and / or maximum treatment frequency and / or duty cycle. In some cases, the treatment frequency may relate to a physiological aspect of the subject being treated, such as a frequency synchronized with the cardiac cycle of the subject.

[0062] In an embodiment, configuring a catheter-based treatment includes automatically adjusting the configuration of a catheter-based system. In some cases, when communicating a configuration from a catheter-based information module for a catheter-based treatment, e.g., a treatment plan including configuration settings for a catheter-based treatment, the catheter-based treatment may automatically reflect such configuration settings. For example, when the catheter-based information module communicates a treatment plan including configuration settings (initial configuration or reconfiguration) for a catheter-based treatment, the catheter-based treatment may be automatically configured to apply such configuration settings (in the case of an initial configuration, configured when starting the treatment, or in the case of reconfiguring the catheter-based treatment during treatment, configured when continuing the treatment). In some embodiments, a catheter-based treatment includes presenting a change in the configuration of the catheter-based system for operator approval. That is, the operator of the catheter-based treatment may need to approve the configuration before the catheter-based treatment is configured according to the changed or initial configuration. For example, the catheter-based information module may generate a treatment plan including proposed treatment settings, but the operator needs to approve such a change to the configuration settings before applying such configuration settings to the catheter-based treatment. In some cases, the change to the configuration includes a range of potential configuration settings, and the operator approval includes selecting a specific configuration setting, such as a setting included within the range of potential configuration settings. Typically, the operator is a treatment provider present in the treatment room or present in a control room who controls, monitors, evaluates, or performs other operations during the catheter-based treatment, such as a treatment provider who remotely monitors one or more treatments.

[0063] In an embodiment, an operator of a catheter-based system, such as a physician, sets a configuration such as the number of pulses applied by a balloon catheter. In such an embodiment, the operator may configure such a setting by directly entering this setting into the catheter-based system or based on recommendations or suggestions received from a catheter-based treatment information module. Such recommendations or suggestions may be generated by the catheter-based treatment information module based on imaging results or other input information, i.e., information received by the catheter-based treatment information module based on, for example, imaging results of a relevant tissue or aspects of the catheter-based system.

[0064] In some embodiments, after access is obtained (i.e., for example, in the context of a catheter-based system, for example, the distal region of the catheter has access to the relevant tissue of the subject, i.e., the treatment is initiated such that it is introduced into the subject), the location of the catheter is set (i.e., the catheter or the heart tissue conforming element or the distal crosser unit, or other relevant aspects of the catheter-based system are positioned at a relevant location of the subject, such as proximal to the heart valve), primed (i.e., the fluid present in the catheter-based system is primed), and otherwise prepared to apply treatment to the relevant tissue of the subject. The operator, for example, a physician, controls the catheter-based system (e.g., taps a treatment button) to initiate the treatment. Once initiated, the catheter-based system collaborates with the catheter-based treatment information module (i.e., based at least in part on the treatment plan information provided by the catheter-based treatment information module) to control the treatment administration, including, for example, delivering an appropriate number of energy pulses at an appropriate (potentially variable) energy to the relevant tissue of the subject. As the treatment continues, the catheter-based system collaborates with the catheter-based treatment information module (i.e., based at least in part on the information transmitted to the catheter-based treatment information module) to check for any extensibility changes in calcium rupture, check for rupture status or other failure modes, and continue the treatment administration until the pre-described pulse cycle is delivered. In some cases, the treatment plan information or one or more configuration settings are transmitted to the catheter-based treatment information module and are updated periodically or continuously from the catheter-based treatment information module to the catheter-based system based on the information received from the catheter-based treatment information module.

[0065] Some embodiments are configured to support treatment continuity. For example, for treatment continuity, an operator or a catheter-based system, together with a catheter-based treatment information module, can in any case check, for example, using imaging results, whether a previously treated lesion is being treated again or, instead, whether a new lesion is being treated with the same balloon. In such embodiments, if the same lesion is being treated, the catheter-based system, together with the catheter-based treatment information module, can be configured to continue a treatment that was interrupted during a previous treatment (i.e., generate a treatment plan that reflects the configuration settings corresponding to the location where the treatment was interrupted during the previous treatment) by the catheter-based treatment information module. In such embodiments, instead, if different lesions are being treated, the treatment plan (e.g., the treatment plan generated by the catheter-based treatment information module) can start from the beginning or be reset to another configuration.

[0066] Catheter-based treatment: Embodiments of the present invention may include any desired catheter-based treatment, as is known in the art. In some cases, the catheter-based treatment includes a method of applying pulsatile energy to a location of intraluminal tissue, including, for example, applying a pulsatile balloon catheter system. Further details regarding such catheter-based treatments that may be used in connection with the methods and systems described herein are provided in U.S. Application No. 63274832, the disclosure of which is incorporated herein by reference. In other cases, the catheter-based treatment includes a method of crossing a total occlusion, including, for example, applying a microcatheter system for crossing the total occlusion. Further details regarding such catheter-based treatments that may be used in connection with the methods and systems described herein are provided in U.S. Application No. 63238381, the disclosure of which is incorporated herein by reference. In still other cases, the catheter-based treatment includes a method of applying pulsatile energy to cardiovascular tissue, including, for example, applying a system for applying pulsatile energy to cardiac valve tissue. Further details regarding such catheter-based treatments that may be used in connection with the methods and systems described herein are described in U.S. Patent Application No. 63346703, entitled "Systems and Methods for Treating Cardiovascular Tissue," filed on the same date as this application (Attorney Docket No.: AVSI-004PRV), the disclosure of which is incorporated herein by reference. Embodiments of the present invention may include catheter-based treatments for implanting devices. For example, embodiments may include catheter-based treatments for implanting devices such as stents, such as self-expanding stents, or replacement heart valves, such as artificial heart valves or donor heart valves. Such embodiments may be applied such that the treatment plan relates to guidance intended to affect and / or predict the desired behavior of a device, such as the implanted device.For example, in the case of a catheter-based procedure for deploying a stent, the treatment planning information may relate to predictions about how such a stent will respond upon deployment, e.g., whether the stent will jump forward when using a self-expanding stent, or how the stent and the vascular tortuosity will respond when the stent is deployed, or whether the stent will cause edge dissociation, or whether the stent will fully expand, or whether the blood vessel will require more preparation. In the case of a catheter-based procedure for deploying a replacement heart valve, the treatment planning information may relate to predictions about how the replacement heart valve will seat and function.

[0067] Sensor: In certain embodiments, a catheter-based system configured to perform aspects of a catheter-based treatment according to embodiments of the present invention (e.g., a system including a heart tissue conforming element or an angioplasty balloon or a catheter) may comprise one or more sensors (e.g., pressure, temperature, volume sensors, etc.) configured to acquire data from one or more locations throughout the catheter-based system before, during, and / or after performing the catheter-based treatment. Such data may include information communicated to and / or from a catheter-based treatment information module in embodiments of the present invention. In such embodiments, since the sensors are configured to transmit and / or receive information to / from a controller or another aspect of the catheter-based system, in any case, such information can be communicated to and / or from a catheter-based information module, or in other cases, the sensors may be configured to communicate information directly to and / or from a catheter-based treatment information module. In such examples, data collected from the sensors may be fused to evaluate the behavior of the catheter-based system or tissue, e.g., cardiovascular tissue, and the catheter-based treatment may be performed on the cardiovascular tissue at different frequencies or amplitudes of pressure applied by aspects of the catheter-based system such as an angioplasty balloon or a heart tissue conforming element or an angioplasty balloon or a catheter. A controller or other aspect of the catheter-based system or a catheter-based treatment information module may be configured to read data from the sensors and adjust the treatment applied via a treatment provided to the cardiovascular tissue in the form of, e.g., feedback and / or feedforward loops.The controller of the catheter-based system or other aspects or the catheter-based treatment information module may also be configured to determine a more optimal treatment profile or treatment plan (i.e., a system configuration such as pressure, frequency, and / or duty cycle configuration for implementation by a catheter-based system to address a disease state, e.g., calcification present in cardiovascular tissue or other disease states in related tissues). That is, the catheter-based treatment information module may generate a revised treatment plan based on information collected during the performance of a catheter-based treatment, i.e., sensor data. Other aspects of the controller or catheter-based system or catheter-based treatment information module may be configured to adjust the treatment profile so that the treatment is performed according to a previously determined optimal treatment profile. Any convenient commercially available sensor (e.g., pressure, temperature, volume sensor, etc.) may be utilized when performing a catheter-based treatment, i.e., when utilized in a catheter-based system and integrated into aspects of the system as needed based on the sensor. Any convenient commercially available means for communicating the data collected by the sensor to the controller or directly to the catheter-based treatment information module may be utilized in connection with embodiments of the present invention, e.g., wired or wireless data connections such as network connections, dedicated communication lines or buses, etc.

[0068] Robot aspect: Another aspect of an embodiment of the present invention relates to robotic treatment of diseased tissue, such as cardiovascular tissue. In one configuration, a catheter-based system for performing a catheter-based procedure in connection with the implementation of an embodiment of the present invention is placed at a treatment location, i.e., a location such as a treatment room or operating room where such a system is used to treat a subject. Connected to the treatment location is a control room that includes access to system control and / or system results, such as data collected by sensors of the catheter-based system, and an embodiment of a catheter-based treatment information module, or a connection to the catheter-based treatment information module of the present invention, such as a network connection. The control room can be operably connected to components of the catheter-based system present at the treatment location via any convenient connection, such as a wired or wireless data connection. The control room can include various displays for displaying information related to the catheter-based procedure using the catheter-based system, such as an imaging sensor or a device sensor. Additionally, the control room can include a treatment controller such that an operator can control various aspects of the treatment, such as the start of treatment and the positioning of the device, i.e., the position of a catheter or angioplasty balloon or a heart tissue conforming element with respect to the tissue, i.e., the cardiovascular tissue of the subject present in the treatment room. Such a treatment controller can be operably connected to the catheter-based treatment information module, and as a result, the catheter-based information module can interface with the controller and control, for example, the aspects of the catheter-based system for performing the catheter-based procedure, either directly or via operator approval, i.e., generate, store, and / or transmit treatment plan information related to the control of the aspects of the catheter-based system when performing a catheter-based procedure related to the cardiovascular tissue of the subject. As described above, the treatment profile or treatment plan can include system configurations such as pressure, frequency, and / or duty cycle configurations for implementation by a catheter-based system for addressing calcifications present in the cardiovascular tissue.Other aspects of the control room may include information about the subject, such as the display of a patient's vital signs, or other pre-treatment and / or during-treatment and / or post-treatment information.

[0069] In some cases, the control room can be several feet away from the operating table, such as behind a lead curtain or other form of shielding, or located in a different geographical location, such as a different building or a different city or country. One or more operators may be able to communicate in the control room and can transmit information to the subject or other operators at the treatment location.

[0070] Visualization: Performing the catheter-based procedure of the present invention may further include using a system that includes marker bands present in aspects of the system, such as a catheter or an angioplasty balloon or a cardiac tissue conforming element. The marker bands can be fixed to different components of the system, such as at various locations on a catheter, a cardiac tissue conforming element, or a guidewire screwed through the catheter. The marker bands can be used to visualize the position of the system or component when the system, or a component of the system such as a cardiac tissue conforming element, is applied to the subject via any convenient fluoroscopy technique. The results of the visualization technique, such as the location, configuration, or orientation of the catheter-based system for performing the catheter-based procedure of the present invention, can include data communicated to the catheter-based information module and / or data communicated from the catheter-based information module. In an example, the catheter-based information module can be configured to evaluate the visualization information, such as by performing image processing to evaluate any relevant aspects of the catheter-based procedure, such as changes in tissue characteristics resulting from performing the catheter-based procedure, or changes in the location of the catheter-based system relative to the subject during the performance of the catheter-based procedure.

[0071] The marker bands used in the embodiments are any convenient and readily available marker bands that can be, for example, crimped, or pressure-bonded, or thermally bonded, or welded, or attached to the components of the catheter-based system. The marker band of interest can be a polymer band loaded with gold or platinum or tungsten, or another material that facilitates visualization such as visualization by fluoroscopy. The marker band can be visualized via visualization techniques of fluoroscopy or radioscopy.

[0072] Embodiments of the present invention can be configured to take into account the anatomical location of catheter-based procedures in order to fuse imaging data with treatment data (e.g., fuse imaging data with other data acquired before, during, or after treatment). Such embodiments can overlay pre-treatment and post-treatment results and be used to determine the results. Such embodiments can include registration of pre-treatment and post-treatment imaging data.

[0073] Certain embodiments of the present invention may apply imaging techniques such as, for example, optical coherence tomography (OCT) or intravascular ultrasound (IVUS) imaging or fluoroscopy or other imaging modalities. In some examples, such embodiments may further use techniques at least partially based on such imaging to automatically measure calcium structures (i.e., calcium eccentricity, calcium thickness and / or calcium length) present in the associated tissue, assign a score representing such aspects of calcium present in the associated tissue, and generate a treatment plan, which may include, for example, peak pressure, frequency and / or intravascular lithotripsy energy, at least partially based on such score. For example, any available technique for scoring based on imaging results may be used, including an OCT / IVUS scoring system based on Zhang et al., Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial, J Am Coll Cardiol. 2018 Dec 18;72(24):3126 -3137, doi:10.1016 / j.jacc.2018.09.013, Epub 2018 Sep 24, PMID:30261237, or an angiography scoring system based on Rocha-Singh, et al., Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications, Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20, doi:10.1002 / ccd.25387, Epub 2014 Feb 10, PMID:24402839; PMCID:PMC4262070. Each reference is incorporated herein by reference in its entirety. In embodiments, such a scoring system may be applied for pre-treatment planning, and additional measurements may be made during or after treatment to measure the amount of cracking of the calcium structure.To ensure that optimal treatment energy is delivered, embodiments may include counting cracks generated in a calcium structure and, in some cases, may further include notifying the clinician whether sufficient energy has been applied to treat the lesion. Such processes may be performed on a per-patient basis or may rely on a learning algorithm such as a cloud-based learning algorithm (i.e., OCT or IVUS images before, during, and / or after treatment may be fused with treatment data to estimate the number of calcium cracks and lumen dilations that occur). Based on such results, future treatments, i.e., treatment plans generated later using such data, output an appropriate amount of energy to ensure that sufficient cracking occurs to achieve the most optimal lumen gain in the safest manner.

[0074] Various aspects of the method of embodiments of the present invention have been outlined above, and aspects of the method of the present invention are further considered in the context of specific embodiments.

[0075] Specific embodiments Aspects of the claimed invention are described in connection with such embodiments without limiting the invention to the embodiments of the methods described in the figures below, which are for illustrative purposes only.

[0076] An exemplary catheter-based system for use in performing catheter-based procedures in connection with embodiments of the present invention is schematically illustrated in FIG. 1. In the embodiment depicted in FIG. 1, the system is configured to impart pulsatile energy to cardiovascular tissue. In some examples, the system can include a console assembly having a potential energy source, such as a high voltage or pressure source, e.g., a regulator for adjusting the output of the pressure source, and a controller, e.g., for controlling aspects of the system. The system can also include a manifold assembly operably connected to the output of the console assembly, the manifold assembly comprising an oscillator for converting the output of the potential source into pulsed energy. The system can also include a catheter assembly operably connected to the output of the manifold assembly for converting the output of the manifold assembly (i.e., the first pulsatile energy) into, e.g., hydraulic vibrations or other forms of oscillatory potential energy (i.e., the second pulsatile energy) and transmitting the second pulsed energy through a catheter (i.e., the fluid passage of the catheter) to a heart tissue conforming element. The heart tissue conforming element can be configured to receive the oscillatory potential energy and apply pulsatile energy to the cardiovascular tissue. In an embodiment, the oscillatory potential energy acts to drive aspects of the heart tissue conforming element, such as balloon angioplasty vibrations or the movement of a radial member, to bend or flex the cardiovascular tissue, for example. The controller can control the frequency, duty cycle, and / or amplitude of the energy output from the potential source of the console assembly and the oscillator of the manifold assembly. The connector of the catheter assembly can convert the energy output by the manifold assembly into, e.g., hydraulic vibrations, thereby generating vibrations in the aspects of the heart tissue conforming element.

[0077] FIG. 1 depicts a schematic diagram of an exemplary embodiment of a system 100 for imparting pulsatile energy to cardiovascular tissue in accordance with the present invention. An exemplary system 100 for performing a catheter-based procedure depicted in FIG. 1 can include a console assembly (i.e., a console subsystem) 110 that can include one or more console units 120, a manifold assembly (i.e., a manifold subsystem) 140 that can include one or more sub-units including an oscillator 141, and a catheter assembly (i.e., a catheter and balloon subsystem) 150 that can include one or more connectors 151, a fluid passage (not shown), and a catheter 154 with a heart tissue conforming element 165. Each connector 151 of the catheter assembly 150 is connected to an oscillator 141 of the manifold assembly 140 and one or more connector catheter transition hubs 153 for transmitting pulsatile energy (i.e., a second pulse energy) to the heart tissue conforming element 165 via the catheter 154.

[0078] The console assembly 110 may comprise one or more console units 120. When the console assembly includes a plurality of console units, such console units may be combined in a single physical component (i.e., housing) or separated into a plurality of housings, e.g., one housing per console unit. In each case, the console units are configured to operate independently of each other, i.e., they can be controlled independently whether the console units are present within a single housing or within a plurality of housings. The console unit 120 includes a potential source 121 for generating energy that is transmitted to the manifold assembly 140, a potential regulator (not shown), and a controller 130. The output from the potential source 121 may include regulated potential energy 122 or unregulated potential energy, such as from a high-pressure fluid or voltage. The potential regulator may be used to modify the potential energy output from the potential source 121 into a form that can be transmitted and further manipulated by the manifold assembly 140, i.e., the oscillator 141 can generate pulsed energy from the energy transmitted from the potential source 121. A plurality of console units 120 (i.e., console units numbered from 1 to n) may be included in the console assembly 110 and can operate substantially in parallel (i.e., independently) to generate a plurality of potential outputs 122 that are transmitted to the plurality of oscillators 141. In some examples, the plurality of console units 120 may be configured to generate a plurality of potential outputs 122 when the treatment of cardiovascular tissue involves applying pulsatile energy of different configurations to the cardiovascular tissue, e.g., the cardiac tissue conforming element includes a plurality of balloons configured to potentially expand independently at different frequencies, duty cycles, and / or amplitudes.In such examples, the different potential outputs 122 can be applied separately to the cardiovascular tissue, for example, via different balloons or other aspects of the heart tissue conforming element, or over different times (i.e., one potential output is operably connected to the balloon at a first time and then another potential output is operably connected to the balloon at a second time). In other examples, potential outputs 122 from multiple console units 120 can be combined. In still other examples, when the treatment of the cardiovascular tissue requires the application of different forms of energy, the multiple console units 120 can be configured to generate multiple potential outputs 122 that include different forms of potential energy (e.g., high pressure or voltage).

[0079] The console assembly 110 further includes a controller 130 configured to receive inputs from at least one of the console assembly 110, the manifold assembly 140, and the catheter assembly 150. The controller 130 is further configured to be operably connected to a catheter-based treatment information module 199 such that data regarding catheter-based treatments performed by the system 100 can be communicated to and / or from the catheter-based treatment information module 199. In FIG. 1, the controller 130 is shown receiving an input from the catheter assembly 150, i.e., from the sensor 152 of the catheter assembly 150. The sensor 152 can comprise any sensor configured to detect any relevant characteristic of the detectable catheter assembly 150. For example, the sensor 152 can comprise a pressure transducer configured to measure pressure within the catheter assembly 150, such as, for example, the pressure of a fluid channel of the catheter 154 or the pressure of an aspect of a heart tissue conforming element 165 such as an angioplasty balloon. Alternatively, the sensor 152 can include a volume sensor configured to measure, for example, the volume of fluid present in a balloon. In the example, the controller 130 can be configured to receive inputs from a plurality of sensors including sensors (such as pressure sensors, temperature sensors, volume sensors, etc.) configured to measure any relevant aspect of the system 100 or the environment to which the system 100 is applied, and can be configured to capture data from any location throughout the system 100, including, for example, one or more locations of the system 100 such as the heart tissue conforming element 165, the catheter 154, the connector catheter-to-catheter transition hub 153, the connector 151, the oscillator 141, or a location on the console unit 120. Generally, in embodiments, sensors can be configured at any desired location of the system 100 to collect any desired information regarding the use of the system, for example, in relation to a treatment procedure.In other examples, the controller 130 may be configured to receive input from a user input such as a button or switch to specify treatment options (e.g., system pressure, frequency, duty cycle, etc.), or to correct or update treatment options or configurations, and to verify or revise aspects of a treatment plan generated and then communicated by, for example, the catheter-based treatment information module 199. In FIG. 1, the controller 130 receives input from the pressure transducer 152 of the catheter assembly 150 and generates a control signal for controlling aspects of the console assembly 110, such as, for example, the magnitude of the potential output 122, based at least in part on such input, i.e., generates via an active regulator (not shown) that is used to adjust the magnitude of the potential output 122 (e.g., output pressure).

[0080] In the embodiment schematically illustrated in FIG. 1, the output of the console assembly 110 is operably connected to the manifold assembly 140, and the energy transmitted from the potential source 121 of the console unit 120 (i.e., the regulated potential output 122) is transmitted to the oscillator 141 of the manifold assembly 140. The oscillator 141 is configured to generate pulsating energy or static energy from the energy transmitted from the potential source 121 (i.e., the regulated potential output 122). In an example, the oscillator 141 may include a solenoid valve (not shown) configured to enable or interrupt the transmission of energy to the catheter assembly 150. In other examples, the oscillator 141 may include any applicable electrical, e.g., an electrical solenoid, optical, or mechanical switch, as is well known in the art.

[0081] In FIG. 1, a controller 130 connected to the manifold assembly 140 is shown. In an example, the oscillator 141 may be configured such that the oscillation frequency and / or duty cycle can be controlled by the controller 130, such that, for example, the controller 130 controls the position or other aspects of the solenoid behavior of the oscillator 141.

[0082] In the embodiment schematically illustrated in FIG. 1, the output of oscillator 141 of manifold assembly 140 is operably connected to catheter assembly 150. In particular, the output of oscillator 141 is connected to the input of connector 151. Connector 151 is configured to convert potential energy, such as pneumatic pressure (i.e., the first pulse energy) generated by oscillator 141, into a second potential energy, such as hydraulic pressure (i.e., the second pulse energy). The system 100 shown in FIG. 1 includes a plurality of connectors 151 (connectors 1 to n), where one connector 151 corresponds to each oscillator 141. The output of connector 151 is operably connected to a connector-catheter transition hub 153 configured to allow the potential energy output of connector 151 (i.e., the second pulse energy) to be input into catheter 154, such as one or more fluid channels (not shown) of catheter 154. In some cases, catheter assembly 150 includes two or more catheters 154, or catheter 154 includes two or more fluid channels inside or outside catheter 154, i.e., different aspects of heart tissue conforming element 159 can be operated independently (e.g., different angioplasty balloons or radial members constituting heart tissue conforming element 159 can be pressurized or inflated and deflated independently).

[0083] In the catheter assembly 150 of the system 100, the catheter 154 includes a dedicated guidewire channel such that the catheter 154 and the heart tissue conforming element 159 can be navigated to the cardiovascular tissue treatment site via a standard over-the-wire guidewire technique. The connector catheter-to-catheter transition hub 153 is configured to include a guidewire exit port 161 for the proximal region of the guidewire threaded through the guidewire channel of the catheter 154. The guidewire exit port 161 is opposed to a guidewire inlet port 157 present in a relatively distal region of the heart tissue conforming element 165. For purposes of illustration only, and to emphasize the location of the guidewire exit port 161 relative to other components of the system 100, the guidewire exit port 161 is depicted as being oriented away from the longitudinal axis of the catheter 154. In an embodiment, the guidewire exit port 161 is oriented in a manner parallel to the longitudinal axis of the catheter 154 (and thus parallel to the longitudinal axis of the guidewire channel within the catheter 154) to avoid unnecessary bending of the guidewire present in the system 100. As described above, the system 100 can be configured with respect to the guidewire to be a system such as an over-the-wire, rapid exchange, monorail, etc. system.

[0084] In the system schematically illustrated in FIG. 1, the heart tissue conforming element 165 is present in the distal region of the catheter 154. In system 100, the heart tissue conforming element 165 is configured to conform to cardiovascular tissue including the aortic heart valve so as to span the leaflets of the aortic valve and have a distal region of the heart tissue conforming element 165 that is present on the ventricular side of the aortic valve and a proximal region that is present on the aortic side of the aortic valve. The heart tissue conforming element 165 includes a plurality of angioplasty balloons and other features (e.g., positioning elements or protrusions, etc.) configured to engage the configuration of the aortic heart valve. The angioplasty balloons of the heart tissue conforming element 165 include one or more outer cross-linking balloons (e.g., wing balloons) 158 and one or more inner valve-forming balloons (e.g., intermediate radius balloons) 159. The angioplasty balloons 158, 159 of the heart tissue conforming element 165 can be operable independently (i.e., pressurization and depressurization are possible regardless of whether other balloons are pressurized or depressurized).

[0085] The outer cross-linking balloon 158 is present at a relatively outer radial distance from the longitudinal axis of the heart tissue conforming element 165 sufficient to engage (i.e., apply pulsatile energy to) the aortic valve commissure, for example, to split a calcium layer within the aortic valve commissure that inhibits proper valve function. The outer cross-linking balloon 158 can include a non-stretchable / stretchable composite material. The heart tissue conforming element 165 can comprise a plurality of outer cross-linking balloons 158 configured such that the outer cross-linking balloon 158 engages each commissure of the aortic valve, for example, three outer cross-linking balloons 158 for engaging each aortic valve commissure.

[0086] The outer cross-linked balloon (e.g., a winged balloon) 158 is operable independently of the second outer cross-linked balloon and the inner valve-forming balloon 159, i.e., can be configured to be independently pressurized and depressurized, by being pressurized, for example, by hydraulic pressure transmitted through a separate fluid chamber of the catheter 154. Alternatively, the outer cross-linked balloon 158 can be configured to be pressurized and simultaneously depressurized by hydraulic pressure transmitted through a single fluid channel of the catheter 154 that supplies hydraulic pressure to, for example, a plurality of outer cross-linked balloons 158.

[0087] The inner valve-forming balloon (e.g., an intermediate radius balloon) 159 is present at a relatively inner radial distance from the longitudinal axis of the heart tissue conforming element 165 sufficient to allow the inner valve-forming balloon 159 to engage (i.e., apply pulsatile energy) the aortic valve leaflets to, for example, split a calcium layer of the aortic valve leaflets that inhibits proper valve function. The heart tissue conforming element 165 can comprise a plurality of inner valve-forming balloons 159 configured such that the inner valve-forming balloon 159 engages each leaflet of the aortic valve. For example, the heart tissue conforming element 165 can comprise three inner valve-forming balloons 159 for engaging each aortic valve leaflet or a single inner valve-forming balloon 159 configured such that different surfaces of the single balloon engage each aortic valve leaflet.

[0088] The inner valve-forming balloon 159 is operable independently of the second inner valve-forming balloon and the outer cross-linked balloon 158, i.e., can be configured to be independently pressurized and depressurized, by being pressurized, for example, by hydraulic pressure transmitted through a separate fluid chamber of the catheter 154. Alternatively, the inner valve-forming balloon 159 can be configured to be pressurized and simultaneously depressurized by hydraulic pressure transmitted through a single fluid channel of the catheter 154 configured to supply hydraulic pressure to a plurality of balloons such that all are pressurized and depressurized simultaneously.

[0089] In system 100, schematically illustrated in FIG. 1, catheter 154 and cardiac tissue conforming element 165 are configured to allow fluid, such as blood, to perfuse across cardiac tissue conforming element 165 even while pulsatile energy is being applied to cardiovascular tissue at the treatment site. For example, in system 100, catheter 154 and cardiac tissue conforming element 165 allow blood to be moved from perfusion inflow zone 156 to perfusion outflow zone 155 via one or more passageways (not shown), i.e., to perfuse, for example, by fluidly connecting perfusion inflow zone 156 to perfusion outflow zone 155 and allowing blood received from the distal region (i.e., the ventricular region) to flow out from the proximal region of cardiac tissue conforming element 165 (i.e., the aortic region). Perfusion inflow zone 156 and perfusion outflow zone 155 comprise perforations or ports (not shown) in catheter 154 or cardiac tissue conforming element 165 through which blood can flow. Such a configuration allows blood flow through cardiac tissue conforming element 165 and allows for an extended treatment time. Such a perfusion mechanism may further comprise a structure (e.g., a valve or oscillating balloon mechanism) within catheter 154 or cardiac tissue conforming element 165 that allows fluid to flow in only one direction. Catheter 154 comprises a proximal catheter section 163 and a distal catheter perfusion section 162. Distal catheter perfusion section 162 comprises a perfusion inflow zone 156, a perfusion outflow zone 155, and, for example, one or more passageways (not shown) fluidly connecting perfusion inflow zone 156 to perfusion outflow zone 155. Proximal catheter section 163 and distal catheter perfusion section 162 may be connected by a connector (not shown).

[0090] Any convenient perfusion mechanism may be used in catheter 154 and heart tissue conforming element 165 to direct the flow of fluid, e.g., blood, through a perfusion zone, i.e., from perfusion inflow zone 156 across heart tissue conforming element 165 to perfusion outflow zone 155, i.e., the flow of blood is moved from the distal region to the proximal region of heart tissue conforming element 165 such that heart tissue conforming element 165 does not completely block the flow of blood when the fluid, e.g., blood, is present, e.g., within a blood vessel. As described above, a passive perfusion mechanism may be used to direct the flow of fluid from perfusion inflow zone 156 to perfusion outflow zone 155 based on an existing pressure gradient, i.e., an existing pressure differential caused, e.g., by ventricular contraction, or an active perfusion mechanism may be used that includes a syringe, e.g., a barrel syringe configured to move fluid through a perfusion zone from perfusion inflow zone 156 across heart tissue conforming element 165 to perfusion outflow zone 155.

[0091] For example, aspects of system 100, such as console assembly 110 (e.g., controller 130), manifold assembly 140 (e.g., oscillator 141), and catheter assembly 150 (e.g., connector 151 and interconnector transition hub 153), may be configured to be reusable. In an example, aspects of system 100, such as catheter 154 or heart tissue conforming element 159, may be configured to be single-use (e.g., disposable). The terms "reusable" and "disposable" as used herein and elsewhere in the description are used for convenience in describing catheter-based systems, such as exemplary system 100 illustrated in FIG. 1. However, systems for use in catheter-based procedures are not so limited. Accordingly, any portion of a system used in connection with a catheter-based procedure of the present invention may be configured for single use or multiple uses, as desired.

[0092] FIG. 2 illustrates a flow diagram 200 for implementing a method according to some aspects of the present disclosure for performing a catheter-based procedure on a subject and communicating data regarding the catheter-based procedure to and / or from a catheter-based procedure information module. An exemplary catheter-based procedure implemented in connection with flow diagram 200 may include, for example, applying pulsatile energy to cardiovascular tissue using a catheter-based system, such as catheter-based system 100 described in FIG. 1.

[0093] The process begins at block 205 of flowchart 200 to initiate treatment, i.e., the method according to some aspects of the present disclosure is initiated. From step 205, the workflow continues to step 210. At block 210, pre-treatment data regarding the subject is collected before performing a catheter-based procedure on the subject. The pre-treatment data collected at block 210 may include, for example, imaging data, vital sign data, or other measurements related to any relevant aspect of the catheter-based procedure, such as other measurements related to the subject or the catheter-based system used to perform the procedure. Imaging data as described above may include, for example, one or more of angiographic imaging, computed tomography, optical coherence tomography, intravascular ultrasound imaging, cardiac echo imaging, or any other desired imaging technique that may be used in relation to a catheter-based procedure. In some cases, the imaging data is used to visualize aspects of the diseased tissue that the catheter-based procedure is intended to address. In other cases, the imaging data is used to visualize aspects of the subject, such as the subject's anatomical structure, or aspects of the catheter system. Vital sign information as described above may include, for example, body temperature, heart rate, respiratory rate, or any other physiological measurement of the subject related to the catheter-based procedure, as is known in the art. Other measurements as described above, i.e., pre-treatment measurements, may include, for example, ventricular pressure, aortic pressure, coronary artery pressure, electrocardiogram results, or any other relevant measurement related to the subject or the catheter-based procedure, such as measurements of aspects of the catheter-based system used to perform the catheter-based procedure. The pre-treatment information as described above collected at block 210 may be collected by a catheter-based system used in relation to performing a catheter-based procedure, such as system 100 of FIG. 1, or may be collected using another device or system capable of either or both collecting relevant pre-treatment data and communicating the collected pre-treatment data to such a catheter-based system for performing a catheter-based procedure or directly to the catheter-based procedure information module 299.From step 210, the workflow continues to step 215.

[0094] In block 215, the pre-treatment data collected in block 210 is communicated to a catheter-based treatment information module 299 (290a). The pre-treatment data is communicated to the catheter-based treatment information module 299 so that the pre-treatment data can be read, stored, and analyzed by the catheter-based treatment information module 299 (290a). The catheter-based information module 299 is available at a remote location, for example, on a cloud-based configuration on a cloud cluster that is accessible via any convenient Internet connection such as a network connection, for example, a wired or wireless connection. However, in other cases, the catheter-based treatment information module 299 may be integrated into the catheter-based system used to perform the catheter-based treatment. In an embodiment, analyzing the pre-treatment data by the catheter-based treatment information module 299 includes applying a treatment planning algorithm configured to generate a treatment plan (i.e., a potential configuration of the manner of performing the catheter-based treatment as described above) (in this case, an initial treatment plan) based at least in part on the pre-treatment data communicated to the catheter-based treatment information module 299. As described above, the treatment planning algorithm applied by the catheter-based information module 299 may include a lookup algorithm, for example, an algorithm used to access a data store (e.g., a database) of previously performed catheter-based treatment data, and in some cases, having equivalent pre-treatment data so that a corresponding treatment plan can be applied. In other cases, the treatment planning algorithm applied by the catheter-based information module 299 may include one or more machine learning algorithms trained to generate a treatment plan based at least in part on at least a portion of the pre-treatment data collected in block 210.At block 215, the treatment planning algorithm further configures the pre-treatment data received at block 210 to be stored in a data store, such as a cloud-based data store, for subsequent access (i.e., lookup) by, for example, the treatment planning algorithm or for use in training or improving or further training the machine learning algorithm of the treatment planning algorithm. At block 215, a treatment plan (i.e., treatment profile) is generated based on at least a portion of the pre-treatment data collected at block 210. The resulting treatment plan includes one or more initial configuration settings of a catheter-based system used to perform a catheter-based procedure.

[0095] Any convenient technique can be applied in relation to a catheter-based information module 299 that receives (290a) and processes pre-treatment data collected at block 210 (similarly, receives (290c) and processes in-treatment data collected at blocks 240 and 245, and receives (290d) and processes post-treatment data collected at blocks 265 and 270). That is, any convenient technique can be applied such that the data received by the catheter-based information module 299 is meaningful with respect to, for example, updating a database of catheter-based treatment information such as generating a treatment plan and / or configuring settings. In some cases, such techniques include tagging relevant data by a physician and performing database comparison and / or look-up in relation to the data received by the catheter-based information module 299. In some cases, the treatment data can be presented to other trained personnel such as clinicians or medically trained staff for tagging, classifying, or identifying relevant features or aspects of the collected data. In some cases, such data identification processes can be gamified to receive rewards such as in the form of payment or credit in exchange for processing the data (e.g., tagging, classifying, or identifying relevant features of data collected in relation to catheter-based treatment). Other techniques can be applied to leverage the accumulated expertise of trained personnel for building a set of well-tagged / classified / identified data, such as a peer review program for group-based evaluation of techniques such as those based on S. Spehar, et al., Blinded Cross-Institutional Peer Review Across Michigan: An Innovative Initiative for Improving Percutaneous Coronary Intervention (PCI) Appropriateness and Quality, J Am Coll Cardiol. 2022 Mar, 79(9_Supplement)615. This document is incorporated herein by reference.

[0096] From step 215, the workflow proceeds to step 220.

[0097] In block 220, the pre-treatment data is analyzed by the catheter-based information module 299, i.e., the results of applying the treatment planning algorithm are displayed. For example, such results may be displayed on a monitor or screen configured for review by an operator or treatment provider. In particular, in block 220, information regarding the treatment plan, i.e., the optimal treatment profile, is communicated (290b) from the catheter-based treatment information module 299 and displayed for review by the operator. Such a treatment plan communicated (290b) from the catheter-based treatment information module 299 is displayed on a display operably connected to the catheter-based system, i.e., for approval by the operator in order to perform the catheter-based treatment. Such an operator may be a treatment provider or a person assisting in the performance of the catheter-based treatment present in a control location transferred from the treatment location or the catheter-based treatment location, e.g., a control room. The elements of the treatment plan communicated (290b) from the catheter-based treatment information module 299 in block 220 may include the device type, which, as known to those skilled in the art, includes balloon type (i.e., size, shape, stretchability characteristics, material, other features such as positioning knobs), treatment type (i.e., pulsatile energy, electrostatic energy, application of pressure or other forms of energy), treatment duration (i.e., the amount of time for which the catheter-based treatment, or that aspect thereof, is applied), treatment intensity (i.e., the minimum and / or maximum magnitude of the energy applied via the catheter-based treatment), treatment frequency (i.e., the frequency of the pulsatile energy applied via the catheter-based treatment or the duty cycle of the catheter-based treatment), or any other configuration setting related to the catheter-based treatment. From step 220, the workflow proceeds to step 225.

[0098] At block 225, the treatment plan (i.e., the initial treatment plan) or aspects thereof generated by the catheter-based treatment information module 299 are presented for approval to an operator or treatment provider responsible for controlling aspects of the catheter-based treatment, e.g., a clinician near the treatment location, e.g., a control room or treatment room. The catheter-based system for performing the catheter-based treatment may include any convenient display or monitor for presenting the treatment plan to the operator. The catheter-based system for performing the catheter-based treatment may further include one or more input devices for the operator to confirm agreement with the proposed treatment plan, e.g., by clicking a confirmation button using a touchpad device such as a mouse or touch screen.

[0099] From block 225, if the operator confirms agreement with the treatment plan, the process moves to block 235. Alternatively, if the operator indicates a desire to change aspects of the treatment plan, the process proceeds to block 230 where the operator may enter an alternative treatment plan, e.g., one or more alternative configurations or settings including the treatment plan, referred to as the treatment determined by the clinician (e.g., the operator may indicate that a different balloon type is to be used during the catheter-based treatment). That is, from block 225, if the operator enters an alternative configuration, the process moves to block 230. Any relevant aspects of the treatment plan may be reconfigured at block 230, i.e., the catheter-based system may be configured to have the ability for the operator to overwrite any configuration settings of the catheter-based treatment, such that the treatment plan effectively includes the initially proposed configuration. Entering an alternative configuration setting at block 230 causes the process to proceed to block 235.

[0100] In block 235, the initial treatment plan, i.e., the initial configuration of the catheter-based treatment, is finalized via operator confirmation or correction in blocks 225 and 230, i.e., the initial treatment plan is ready to be applied to the catheter-based treatment and includes either the treatment plan generated by the catheter-based treatment information module 299 or the treatment plan corrected or otherwise updated by the operator, i.e., the clinician, in block 230. When the configurations (e.g., device type, balloon type, etc.) included in the treatment plan are applied, the catheter-based treatment is initiated in block 235. Initiating the catheter-based treatment in block 235 means, as known to those skilled in the art, that a catheter-based device, i.e., a catheter and a balloon, or other treatment device fixed to the distal end of the catheter, is selected and prepared for treatment, i.e., application to the subject. Initiating the catheter-based treatment further includes, for example, accessing the treatment site via insertion of the catheter and the catheter device into the subject. For example, if the catheter device includes a heart tissue conforming element, a heart tissue conforming element configured in an appropriate size, e.g., a heart tissue conforming element with a winged balloon for addressing calcification of the heart valve commissure, is selected and the heart tissue conforming element is positioned near the diseased heart valve of the subject. When the treatment is initiated in block 235, the process proceeds to block 240.

[0101] In block 240, the catheter-based treatment proceeds such that the treatment is deployed by configuring the catheter-based treatment to deliver energy, e.g., pulsatile energy, to the tissue, i.e., the cardiovascular tissue of the subject. That is, in block 240, the catheter-based treatment delivers the treatment in a form that delivers energy to the tissue (e.g., to break up calcification in the tissue of the subject). For example, if in block 240 the catheter-based treatment includes applying pulsatile energy to the tissue, such pulsatile energy is applied to and delivered to the tissue.

[0102] Furthermore, in block 240, in-treatment data (i.e., during-treatment data) regarding catheter-based procedures is collected. For example, sensors, including internal and external sensors of a catheter-based system for performing catheter-based procedures, are configured to collect data regarding the treatment and / or the subject. As described above, the in-treatment data can include device sensor data (e.g., pressure or volume measurements), imaging data (e.g., ultrasound images showing the position of the catheter device aspect relative to tissue or an image of the tissue), the subject's vital signs (e.g., pulse, respiratory rate, blood pressure, etc.), or information derived from other measurements related to the catheter-based procedure. Depending on the type of procedure applied, the in-treatment data can include an estimate of the change in tissue extensibility for evaluating the effectiveness of the catheter-based procedure, or other measurements that can be used to evaluate the effectiveness of the catheter-based procedure. Once the in-treatment data is collected, the process proceeds to block 245.

[0103] In block 245, the in-treatment data is communicated (290c) to the catheter-based treatment information module 299, whereby such in-treatment data can be read, stored and / or analyzed by the catheter-based treatment information module 299, which in some cases is integrated into a catheter-based system used to apply a catheter-based treatment and is located locally at the treatment site, or near the treatment site, or remotely, for example, in a distributed system accessible via a network connection, such as a cloud-based configuration. The analysis of the in-treatment data performed by the catheter-based treatment information module 299 can include calculations or lookups against reference data or historical data for evaluating the effectiveness of the catheter-based treatment. In some cases, the analysis of the in-treatment data performed by the catheter-based treatment information module 299 includes comparing the in-treatment data in real time with historical in-treatment data, or applying a machine learning algorithm to evaluate the in-treatment data to assess the effectiveness of the catheter-based treatment based on aspects of the in-treatment data. When the catheter-based treatment information module 299 analyzes the in-treatment data, the result of such analysis of the in-treatment data by the catheter-based treatment information module 299 is communicated (290c) to the catheter-based system, and the process proceeds to block 250.

[0104] In block 250, at least a subset of the analysis results of the in-treatment data by the catheter-based treatment information module 299 is presented to the operator of the catheter-based treatment or the treatment provider to confirm whether the result of applying the catheter-based treatment is satisfactory and thus complete, or unsatisfactory and thus whether it is necessary to continue the catheter-based treatment to apply further treatment. Such results can be presented to the operator using, for example, any convenient display or monitor, and the operator can indicate whether the treatment is satisfactory using any convenient input device such as a mouse or touchpad or touch screen.

[0105] If the operator indicates that the result of the treatment is satisfactory, the process proceeds to block 255 where the treatment is completed, i.e., the catheter-based treatment stops applying energy to the tissue, e.g., the target cardiovascular tissue, and the process proceeds to block 265. If the operator indicates that the treatment is not satisfactory (i.e., the catheter-based treatment should continue to be applied to the diseased tissue), the process proceeds to block 260.

[0106] In block 260, regardless of whether the operator corrects the configuration settings related to the treatment plan, which is the revised treatment plan by the catheter-based treatment information module 299 and / or the operator of the catheter-based treatment, the application of the treatment, i.e., the catheter-based treatment, continues under the same or revised treatment plan generated by the catheter-based treatment information module 299, i.e., the catheter continues to deliver energy to the tissue.

[0107] In some cases, at block 260, additional in-treatment data is collected and communicated to the catheter-based treatment information module, similar to the steps shown in blocks 240 and 245. Further, at block 260, in some cases, a revised treatment plan is communicated from the catheter-based treatment information module 299 to revise the configuration of the catheter-based treatment, i.e., the treatment modality (e.g., treatment type, device type, balloon type, treatment duration, treatment intensity, treatment frequency, etc.) can be modified in relation to the continuation of the catheter-based treatment. Further, at block 260, subsequent in-treatment data can be collected and analyzed such that an operator can indicate whether the treatment is satisfactory based on such results. In response to an indication that the treatment is satisfactory, or in response to the occurrence of another treatment end signal such as the completion of the treatment period, the process proceeds to block 265.

[0108] At block 265, post-treatment data (i.e., post-procedure data) regarding the catheter-based treatment is collected. For example, sensors including internal and / or external sensors to the catheter-based device are configured to collect data regarding the catheter-based treatment. As described above, the post-treatment data can include information from device sensors (e.g., pressure or volume measurements), imaging data (e.g., ultrasound images indicating the position of the catheter device with respect to the tissue or an image of the tissue), the subject's vitals (e.g., pulse, respiratory rate, blood pressure, etc.), or other measurements related to the catheter-based treatment. The post-treatment data also includes outcome information regarding the catheter-based treatment. That is, the post-treatment data can include outcome information including, for example, data regarding tissue extensibility such as acute valve opening, valve extensibility, etc., intravascular pressure or external pressure, etc., at the completion of the catheter-based treatment in each case. Depending on the type of treatment applied, the post-treatment data can include an estimated value of the change in tissue extensibility to evaluate the effectiveness of the catheter-based treatment, or any other measured value related to the catheter-based treatment used to evaluate the effectiveness of the catheter-based treatment. After collecting the post-treatment data, the process proceeds to block 270.

[0109] In block 270, post-treatment data is communicated (290d) to a catheter-based treatment information module 299, whereby such post-treatment data can be read, stored, and / or analyzed by the catheter-based treatment information module 299, which in some cases is integrated into a catheter-based system used to apply a catheter-based treatment and which is either locally present at or near the treatment site or remotely present, for example, in a distributed system, such as a cloud-based configuration, that is accessible via a network connection.

[0110] The analysis of post-treatment data performed by the catheter-based treatment information module 299 can include calculations or lookups against reference or historical data (i.e., generating outcome information, such as conclusions regarding the effectiveness of treatment based on the final data collected from the catheter-based treatment) to evaluate the effectiveness of the catheter-based treatment. In some cases, the analysis of post-treatment data performed by the catheter-based treatment information module 299 includes comparing the immediate post-treatment data to historical post-treatment data or applying a machine learning algorithm to evaluate the post-treatment data to assess the effectiveness of the catheter-based treatment based on aspects of the post-treatment data. When the catheter-based treatment information module 299 analyzes the post-treatment data, the results of such analysis of the post-treatment data by the catheter-based treatment information module 299 are communicated (290d) to the catheter-based system for display and further analysis, for example, by an operator or treatment provider. The process described in the exemplary flowchart 200 ends at block 270.

[0111] FIG. 3 shows, for illustrative purposes, a schematic diagram of a control loop for controlling a catheter-based system while performing a catheter-based procedure, such as a catheter-based procedure for treating a diseased cardiovascular tissue such as a diseased valve, using a catheter-based system such as the system 100 depicted in FIG. 1. In this embodiment, the controller includes receiving a treatment plan (i.e., a set of configurations of a catheter-based procedure, including the configuration of the catheter-based system) supplied to the controller subsystem. The treatment plan can be an initial treatment plan (i.e., a set of configuration settings of a catheter-based procedure specified prior to starting the catheter-based procedure) or a revised treatment plan (i.e., a set of configuration settings of a catheter-based procedure specified some time after starting the catheter-based procedure, e.g., a revised treatment plan updated based on in-treatment data collected while performing the catheter-based procedure), and in either case, is generated by a catheter-based procedure information module, such as the catheter-based procedure information module 299 shown in the embodiment of FIG. 2 or the catheter-based procedure information module 199 depicted as communicating with the catheter-based system 100 of FIG. 1.

[0112] In the embodiment of the controller shown in FIG. 3, based at least in part on the treatment plan input to the controller from the catheter-based procedure information module, the controller subsystem sends a signal in the form of a voltage or data to a potential source (regulated or unregulated potential source) to control the amount of potential output from the potential source to an oscillator. The controller subsystem also determines the frequency (f), i.e., the oscillation frequency, and the duty cycle (t on and t off)Send signals such as to the oscillator to control the periodic energy transmitted by the oscillator. The feed-forward model of individual subsystems (e.g., console assembly, manifold assembly, catheter assembly) or the entire system can be injected into the controller signal (i.e., the controller signal can be enhanced with such data regarding the feed-forward model) to improve the convergence of the controller (i.e., the control algorithm) to the correctly supplied energy.

[0113] Therapeutic energy (i.e., potential energy) is transmitted to the oscillator, and a sensor can be used to track the magnitude of the potential energy transmitted to the oscillator. The sensor signal can be fed back to the controller (and ultimately to the catheter-based treatment information module (not shown) used to generate one or more treatment plans) so that it can be used to converge the output of the system (i.e., the pulsatile energy applied to the cardiovascular tissue) to the desired output. The oscillator is turned on and off at an appropriate frequency and duty cycle so that energy is transmitted to the distal location (i.e., the heart tissue conforming element and ultimately the cardiovascular tissue) in an appropriate manner, taking into account any attenuation, heat conduction, bubble formation, tissue relaxation, etc. The sensor measures system attributes and the characteristics of the tissue, such as cardiovascular tissue, such as pressure, volume, temperature, flow rate, etc. The sensor data from the catheter assembly is fed back to the controller so that such measurements can be used to converge the output of the system (i.e., the pulsatile energy applied to the cardiovascular tissue) to the desired output, such as the desired output specified in the treatment plan input to the controller.

[0114] The catheter assembly sensor can be located at any convenient location of the catheter assembly that can be configured to generate appropriate measurements for controlling the system. For example, the sensor can be a pressure sensor or a volume sensor located on the connector. In other examples, such a sensor can be a sensor located within the catheter or a heart tissue conforming element (e.g., within the balloon of the heart tissue conforming element) or within the angioplasty balloon and is connected to a wire configured to pass through the catheter. In other cases, such a sensor can include the results of an X-ray image of the catheter or a heart tissue conforming element or an angioplasty balloon, or another fluoroscopic imaging technique, which is used to determine the position or expansion of one or more balloons such as the catheter, the heart tissue conforming element or the angioplasty balloon.

[0115] The catheter assembly can include one or more sensors configured to measure information at one location as a means for determining the state at another location. For example, pressure and flow transducers can be configured to measure pressure and flow at the connector, but in combination with, for example, a fluid model of the system and X-ray or CT imaging, the sensor data can be used to measure, for example, the pressure and / or volume of the angioplasty balloon or the balloon of the heart tissue conforming element. In addition, the sensor data can be provided to a clinician feedback transfer function, and such sensor feedback can be combined with feedback generated from potential conduction plant or imaging data for processing by a feedback mechanism plant that provides feedback regarding the system behavior to a provider, i.e., the operator of the system.

[0116] In other examples, pressure and flow sensors can be used to measure the expandability or change in expandability of an angioplasty balloon or a balloon of a heart tissue conforming element. Considering that diseased tissue resists the expansion of the balloon, the amount of volume pushed into the balloon at a particular pressure is an indirect indicator of the expandability of the tissue surrounding the balloon. In this way, a measure of expandability or change in expandability can be used as a treatment metric or goal, and such a measure can be specified in the treatment plan input to the controller.

[0117] FIG. 4 depicts a schematic diagram of a system configuration 400 for use with an embodiment of the method of the present invention. The system configuration 400 can be configured to provide a catheter-based treatment using a catheter-based system such as the system 100 depicted in FIG. 1, and can further be used in connection with robotics for delivering treatment energy to diseased tissue such as a diseased valve operated from a control room. In configuration 400, the catheter-based system can be divided into a physically separated control room 410 and a treatment location 420, and the treatment location 420 can be separated, for example, in an adjacent room or a different city or state or country.

[0118] The control room 410 may include a connection to a treatment database 499, which is a catheter-based treatment information module that exists on or is remotely accessible via a computer network connected to a console display, an imaging display, a treatment controller, a device position controller, patient information, and a computer system present in the control room 410. The console display can be used to provide important information regarding catheter-based treatment and the state of the catheter-based system related to the ongoing treatment, such as pressure or volume measurements, or other information regarding cardiac tissue conforming elements, such as the type of cardiac tissue conforming elements used. The information provided on the console display can be updated periodically, for example, substantially in real-time during the treatment. The imaging display can be used to provide imaging information, such as fluoroscopic imaging results, indicating the position of the cardiac tissue conforming elements with respect to cardiac tissue, such as a heart valve. The fluoroscopic imaging results can also provide information regarding the state of the aspect of the cardiac tissue conforming elements, such as whether the balloon is inflated and to what extent. The treatment controller can be used to adjust the manner in which the catheter-based system is applied, for example, to apply pulsatile energy to cardiovascular tissue, such as by adjusting the pressure or frequency or duty cycle settings. In an embodiment, the treatment controller can adjust the configuration of the catheter-based system at least in part based on a treatment plan, such as an initial treatment plan generated by the treatment database 499 (e.g., an initial treatment plan generated based on pre-treatment data collected in the treatment room 420 and transmitted to the control room 410 for communication with the treatment database 499), or an intermediate or revised treatment plan generated by the treatment database 499 (e.g., an intermediate or revised treatment plan generated based on pre-treatment data and / or in-treatment data collected in the treatment room 420 and transmitted to the control room 410 for communication with the treatment database 499).

[0119] The device position controller can be used to adjust the position of the device relative to the cardiovascular tissue being treated, i.e., one or more aspects of the catheter-based system, for example, to adjust the catheter position to move a angioplasty balloon or a heart tissue conforming element more proximally or distally. Patient information can include the display of any important patient data relevant to the treatment, such as information regarding vital measurements for the clinician or operator to consider, e.g., the treatment site, the patient's age, disease state, blood pressure or pulse oximeter measurements.

[0120] The treatment database 499 (catheter-based treatment information module) includes information regarding past treatment plans (i.e., information related to the system configuration for treating cardiovascular tissue such as oscillation frequency, duty cycle, and / or amplitude, as well as corresponding details regarding the underlying cardiovascular tissue such as the degree of calcification), and this information can be accessed to identify potential treatment plans related to a new treatment. The treatment database 499 can be configured to generate a treatment plan using any convenient technique, i.e., a treatment plan algorithm, such as a lookup-based algorithm that uses matching of the current treatment scenario to past treatments recorded in the treatment database 499, or a model-based approach for estimating an optimal treatment plan including a machine learning model such as a statistical model or, for example, a neural network model, or a deep learning model including a convolutional neural network model, of the configuration of the catheter-based system. In an embodiment, such a treatment generation algorithm including a machine learning algorithm can be trained using catheter-based past data and treatment results. In some cases, such a treatment generation algorithm can be configured to be continuously trained based on the data collected and the results from catheter-based treatments as such treatments are performed step by step. The treatment database 499 (i.e., the catheter-based treatment information module) can be implemented on a computer system present in the control room 410 or can be present at a remote location and implemented on a computer system accessed via the computer system present in the control room 410.

[0121] The treatment location 420 may comprise a system such as the catheter-based system 100 depicted in FIG. 1, i.e., embodiments of the system comprise a console assembly having a potential source, a manifold assembly, and a catheter assembly, and the catheter assembly includes a connector, a connector-to-catheter transition hub, a catheter, and a heart tissue conforming element. The treatment room 420 can be, for example, a procedure room or an operating room in a hospital or a treatment center. Any convenient operable connection can be used to transmit data and control signals between the treatment room 420 and the control room 410, such as a wired connection or a wireless connection, such as an Internet connection or a connection via a private dedicated network.

[0122] Measurement value of extensibility: As will be described in detail below, the extensibility of a tissue, e.g., cardiovascular tissue or a blood vessel, is a measurable property of a blood vessel or a tissue such as cardiovascular tissue including a heart valve, and is calculated based on the ratio of the change in tissue volume to a given pressure change. Since improving blood vessel extensibility is a prerequisite for definitive treatment of certain underlying disease states such as atherosclerosis and the presence of calcifications in cardiovascular tissue, blood vessel extensibility is an important feature to be observed. Changes in blood vessel extensibility are seen in the different pressure-volume curves depicted in FIG. 5. In FIG. 5, volume is plotted on the x-axis and pressure is plotted on the y-axis. The pressure-volume, i.e., blood vessel extensibility, is characteristic of an uninhibited balloon (i.e., a balloon that is not present within the cardiovascular tissue or, otherwise, is not inhibited from expanding its volume with an increase in balloon pressure) and untreated (i.e., pre-treatment) cardiovascular tissue, i.e., untreated blood vessels, and treated (i.e., post-treatment) cardiovascular tissue, i.e., treated blood vessels.

[0123] As shown in FIG. 5, when treating using an embodiment of a catheter-based system such as the system 100 depicted in FIG. 1, for example, applying pulsatile energy to cardiovascular tissue, the pressure-volume curve shifts to the right, i.e., shifts near the curve of the unconstrained balloon. That is, during treatment, the same change in tissue volume corresponds to a reduced tissue pressure, i.e., less pressure on the tissue is required to expand the tissue volume by a similar amount.

[0124] The method and system according to the present invention can be configured to evaluate the distensibility of blood vessels by obtaining in vivo measurements of volume changes at different pressures (or different changes in pressure) applied to cardiovascular tissue such as blood vessels. FIGS. 6A and 6B provide examples of measurements of changes in tissue distensibility obtained during treatment, including catheter-based procedures using a catheter-based system such as the system 100 depicted in FIG. 1, for example, during intracardiac valvulotripsy. FIG. 6A demonstrates obtaining measurements of tissue distensibility, i.e., the pressure applied to the tissue and the corresponding changes in volume over time, using dynamic changes in pressure. FIG. 6A shows that the trend of the peak volume change is upward while the peak applied pressure remains constant. That is, as the treatment progresses, while the same change in pressure is applied, the tissue volume increases to a greater extent, providing an indication of improved tissue distensibility.

[0125] In an embodiment of the method according to the present invention, the pre-treatment data, during-treatment data, and post-treatment data may include tissue extensibility measurements (or data that can be processed together to generate extensibility measurements). In an embodiment, the information communicated to and / or from the catheter-based information module may include tissue extensibility data. In such an embodiment, the catheter-based treatment information module may include a treatment plan generation algorithm that generates a treatment plan, such as a revised treatment plan, based on the during-treatment data, or based on extensibility measurements or changes in extensibility measurements obtained during the application of the catheter-based treatment, or based on a target extensibility goal or a target change in extensibility. In some cases, the catheter-based treatment information module may be configured to communicate a stop or termination command such that the catheter-based treatment is stopped when the associated tissue reaches a specified extensibility value or a specified change in extensibility. For example, the treatment plan may include a command to cycle the pressure applied to the balloon as shown in FIG. 6A, and a further command that if the corresponding balloon volume behaves as depicted in FIG. 6A, such behavior indicates a desired change in tissue extensibility and the catheter-based treatment should be terminated.

[0126] FIG. 6B shows obtaining measurements of tissue extensibility, i.e., the corresponding changes in the pressure applied to the tissue and the volume over time, using a dynamic change in pressure as well as a static pressure (i.e., in the third pressure oscillation, the pressure applied to the tissue remains for about half of the period). FIG. 6B shows that the trend of the peak volume change is upward while the peak applied pressure remains constant. That is, as the treatment progresses, while the same change in pressure is applied, the tissue volume increases to a greater extent, and an indicator of improved tissue extensibility is obtained.

[0127] Embodiments of the method of the present invention enable the measurement of relative extensibility changes of cardiovascular tissue (i.e., blood vessels) in real time during the application of the catheter-based treatment of the present invention to provide pulsatile energy to the cardiovascular tissue. The system for the purpose used in performing the catheter-based treatment of the present invention can be configured to measure and update treatment parameters based on changes in the extensibility of the cardiovascular tissue. For example, after calcium cracking (i.e., crushing of calcified plaque tissue), as measured by the system, the cardiovascular tissue and the angioplasty balloon or heart tissue conforming element, or its balloon, etc., expand significantly and contribute to a large gain in extensibility. However, after the blood vessel is fully expanded, the change in extensibility measured by the system may subside. The identification of such a state (i.e., different degrees of change in extensibility) is defined in the treatment plan or identified by the catheter-based treatment information module, and may indicate that the treatment can be stopped because no further recognizable benefit has occurred.

[0128] The catheter-based system for use in the catheter-based treatment of the present invention can be configured to measure pressure in any convenient manner. In some examples, such a system can include a pressure gauge as described herein for measuring pressure in, for example, a fluid passage and / or an angioplasty balloon or heart tissue conforming element or catheter. In some examples, the pressure gauge can be installed so as to be configured to measure the pressure present at a connector such as connector 151 in FIG. 1.

[0129] A catheter-based system for use in catheter-based procedures of the present invention can be configured to measure changes in the volume of cardiovascular tissue, such as blood vessels, in any convenient manner. In some examples, an embodiment of the system according to the present invention is such that a change in the position of a membrane separating, for example, a proximal chamber and a distal chamber of a connector (such as connector 151 in FIG. 1) reflects a change in the aspect of a cardiac tissue conforming element, such as the volume of a balloon. A change in the volume of the balloon reflects a change in the cross-sectional area of cardiovascular tissue, such as a blood vessel, and thus reflects a change in the volume of the cardiovascular tissue. Such a catheter-based system can further include a Hall sensor for measuring such a change in the position of such a membrane and a permanent magnet. A Hall sensor refers to a sensor configured to sense the presence or change of a magnetic field, i.e., by using the Hall effect. The permanent magnet can be composed of any convenient magnetic material or an electromagnet, as desired, such that a relative change in the position of the Hall sensor with respect to the permanent magnet is detected by the Hall sensor. Sensors such as the Hall sensor described above and the permanent magnet are related to embodiments of the present invention for measuring changes in the volume of a catheter-based system for performing catheter-based procedures, such as an angioplasty balloon or a cardiac tissue conforming element, or one or more of them, such as a balloon, and aspects of such an angioplasty balloon or cardiac tissue conforming element, such as the rate at which one or more of the balloons expand, i.e., the corresponding change in the cardiovascular tissue volume change rate and stretchability.

[0130] System As summarized above, aspects of the present disclosure include a system configured to implement the subject method. A system according to a particular embodiment includes a catheter-based treatment information module, the catheter-based treatment information module including a first processor, the first processor including a memory operably coupled to the first processor, the memory including instructions stored therein, the instructions, when executed by the first processor, causing the first processor to receive data regarding catheter-based treatment from a catheter-based system and to transmit data regarding catheter-based treatment to the catheter-based system. A system according to a particular embodiment further includes a catheter-based system, the catheter-based system including a catheter-based device and a second processor, the second processor including a memory operably coupled to the second processor, the memory including instructions stored therein, the instructions, when executed by the second processor, causing the second processor to transmit data regarding catheter-based treatment to the catheter-based treatment information module, to receive data regarding catheter-based treatment from the catheter-based treatment information module, and to configure the catheter-based device based at least in part on the data regarding catheter-based treatment received from the catheter-based treatment information module. A system according to a particular embodiment further includes an operable connection between the catheter-based treatment information module and the catheter-based system. Any convenient processor and memory may be used in embodiments of the present invention as described above. Any convenient operable connection between the catheter-based treatment information module and the catheter-based system may be used in embodiments of the present invention, such as a wired or wireless computer network connection as described above.

[0131] Catheter-based treatment information module: In an embodiment of the system of the present invention, the catheter-based treatment information module is remote from the catheter-based system. "Remote" means that the catheter-based treatment information module is distinguished from and separated from the catheter-based system, for example, on a different side of a room partition, or in a different room of a building, a different building, a different city, or a different country. In other cases, the catheter-based treatment information module is integrated with the catheter-based system.

[0132] In some cases, the catheter-based treatment information module is configured to store data related to catheter-based treatment. For example, the catheter-based treatment information module can be configured to store pre-treatment information, during-treatment information, or post-treatment information, i.e., outcome information related to catheter-based treatment. In other cases, the catheter-based treatment information module is configured to store data related to catheter-based treatment in a distributed data storage. "Distributed data storage" means that data related to catheter-based treatment can be stored in multiple storage locations or nodes of a computer network, and such nodes can include separate physical locations, for example, cloud-based data storage. Embodiments of the system of the present invention can include multiple catheter-based systems, and the catheter-based treatment information module is configured to interface with each of the catheter-based systems. That is, in an example, the catheter-based system is a first catheter-based system, and the catheter-based treatment information module is configured to receive data from and transmit data to multiple catheter-based systems. In some cases, in such an example, at least two of the multiple catheter-based systems are located in different locations, for example, different catheter-based treatment sites.

[0133] Treatment information: In an embodiment of the system according to the present invention, the data related to the catheter-based treatment transmitted to the catheter-based treatment information module includes, in each case, pre-treatment data, during-treatment data, and / or post-treatment data, as described above. In certain embodiments, the catheter-based device comprises a sensor, and the pre-treatment or during-treatment or post-treatment data includes catheter-based device sensor data. In some cases, the catheter-based device sensor data is the balloon position, balloon deployment rate, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure, or the position of the valve within the valve annulus, or any other measurement detectable via a sensor associated with the catheter-based treatment and integrated into the catheter-based system.

[0134] Treatment plan In an embodiment of the system according to the present invention, the first processor memory further includes instructions that, when executed by the first processor, cause the first processor to apply a treatment plan generation algorithm. In some embodiments, the treatment plan generation algorithm is configured to generate a treatment plan based at least in part on data related to the catheter-based treatment received from the catheter-based system. In other embodiments, the data transmitted by the catheter-based treatment information module includes a treatment plan.

[0135] As described above, the treatment plan may include, for example, device type, balloon type, treatment type, treatment duration, treatment intensity, or treatment frequency. In an embodiment, the treatment plan generation algorithm is configured to compare at least a subset of data regarding catheter-based procedures with data from previous catheter-based procedures. In other embodiments, the treatment plan generation algorithm is configured to access a set of data regarding a plurality of previous catheter-based procedures. In some cases, the treatment plan generation algorithm includes a machine learning algorithm component, and the machine learning algorithm component can be trained using data from one or more catheter-based procedures, such as catheter-based procedures previously completed on the same or different subjects performed at one or more locations.

[0136] Regarding the application of the treatment plan, in some embodiments, configuring a catheter-based device at least partially based on data regarding a catheter-based procedure received from a catheter-based procedure information module includes configuring the catheter-based device at least partially based on the treatment plan. In some cases, configuring the catheter-based device includes applying an initial configuration for the catheter-based procedure. In other cases, configuring the catheter-based device includes reconfiguring the catheter-based device.

[0137] Regarding configuring a catheter-based device, in an embodiment, configuring a catheter-based device includes, for example, selecting a treatment type, treatment duration, treatment intensity, or treatment frequency. In some cases, configuring a catheter-based device includes automatically adjusting the configuration of the catheter-based device. In other cases, configuring a catheter-based device includes presenting a change in the configuration of the catheter-based device for operator approval. Presenting a change for operator approval means, for example, displaying the proposed configuration on an output device such as a monitor or display, such as a touch screen display, and receiving an input indicating approval or modification (i.e., a change to an aspect of the treatment plan), such as touching one or more keys on the touch screen display.

[0138] Catheter-based treatment: In an embodiment of the system of the present invention, the catheter-based system may comprise any convenient catheter-based device for use in interventional treatment of cardiovascular tissue, such as, for example, a balloon catheter device, and such device may be modified as desired. In some embodiments, the catheter-based device comprises a pulsatile balloon catheter system. Further details regarding such catheter-based devices that may be used in connection with the method systems described herein are provided in U.S. Application No. 63274832, the disclosure of which is incorporated herein by reference. In other embodiments, the catheter-based device comprises a microcatheter system for crossing total occlusions. Further details regarding such catheter-based procedures that may be used in connection with the methods and systems described herein are provided in U.S. Application No. 63238381, the disclosure of which is incorporated herein by reference. In yet other embodiments, the catheter-based device comprises a system for delivering pulsatile energy to heart valve tissue. Further details regarding such catheter-based procedures that may be used in connection with the methods and systems are described in U.S. Patent Application No. 63346703, filed on the same date as this application (Attorney Docket No.: AVSI-004PRV) and entitled "Systems and Methods for Treating Cardiovascular Tissue", the disclosure of which is incorporated herein by reference.

[0139] Computer-readable storage medium Aspects of the present disclosure further include a non-transitory computer-readable storage medium having instructions for implementing the methods of the subject matter. The computer-readable storage medium can be used on one or more computers for the complete or partial automation of a system for implementing the methods described herein. In certain embodiments, the instructions according to the methods described herein can be encoded in a computer-readable medium in the form of a "programming", where the term "computer-readable medium", as used herein, refers to any non-transitory storage medium involved in providing instructions and data to a computer for implementation and processing. Any suitable non-transitory storage medium such as a floppy disk, hard disk, optical disk, magneto-optical disk, CD-ROM, CD-R, magnetic tape, non-volatile memory card, ROM, DVD-ROM, Blu-ray disk, solid state disk, and network-connected storage device (NAS) can be used, whether such devices are internal or external to the computer. A file containing information can be "stored" on a computer-readable medium, where "storing" means recording the information such that it is accessible and searchable by the computer at a later date.

[0140] The following examples are provided by way of illustration and not by way of limitation.

Example

[0141] Using system characteristics measured in relation to a model of a catheter-based system, embodiments of the present invention are utilized to control a catheter-based procedure in real-time (e.g., using negative feedback control and / or feedforward control) to ensure that pressure amplitude, duty cycle, and frequency are appropriately set during such a catheter-based procedure. Two examples of experimentally measured pressures within a balloon of a catheter-based system used to perform a catheter-based procedure, and the force output from such a balloon, are shown in FIG. 7. The system model can be used to accurately predict experimental measurements. Using feedback from such a prediction model and system measurements (e.g., in-treatment data such as sensor data as described above), treatment characteristics (frequency, pressure input, and duty cycle) can be adjusted to maximize the treatment effect. Utilizing such features of embodiments of the present invention, for example, in addition to facilitating a more effective catheter-based procedure by optimizing changes in balloon pressure, such features can also be utilized to improve the safety of catheter-based procedures. For example, if a significant change in the pressure and / or volume of the balloon is detected by a sensor within the catheter-based system or by a sensor associated with the catheter-based system, a catheter-based information module or another controller, which is an embodiment of the present invention, can automatically shut down the catheter-based system to prevent a safety hazard.

[0142] An exemplary use for controlling a catheter-based procedure is shown in FIG. 8. During a catheter-based procedure in which the balloon of a catheter-based system is periodically pressurized over time, the decompression pressure of the balloon deviates from the desired range. When this occurs, the catheter-based information module (i.e., the control algorithm of the catheter-based system for controlling the catheter-based procedure) operates to reduce the frequency of the vibration (i.e., the periodic balloon pressurization) such that the balloon has sufficient time to decompress and reach an appropriate pressure range.

[0143] Figure 9 shows exemplary images of calcification in luminal tissue before and after applying a catheter-based treatment (before and after treatment). The effect of applying an optimal treatment plan for controlling the catheter-based treatment can be seen in the post-treatment image, and as a result of applying the catheter-based treatment according to an embodiment of the present invention, calcification has been disrupted at several locations.

[0144] Figure 10 shows a table summarizing the effectiveness of a catheter-based treatment approach based on a peripheral intravenous line (PIVL) under different conditions. The four quadrants of the table present metrics based on different situations regarding when to perform the treatment, i.e., the catheter-based treatment, and when such treatment is most likely to be effective. Embodiments of the catheter-based information module can be configured to apply such metrics when generating a treatment plan. In some cases, the thickness of cracks in calcium deposits can be treated as a treatment objective, and the treatment plan generated by the catheter-based information module may be at least partially based on such an objective. The crack thickness can be, for example, a function of the treatment time and pulse energy applied via the catheter-based treatment.

[0145] FIG. 11 depicts an exemplary X-ray image showing calcium deposits in tissue. Such X-ray imaging may include information communicated to and / or from a catheter-based information module. That is, such an image, or an annotated version thereof, may include pre-treatment, during-treatment, or post-treatment data as described herein. Images such as the X-ray image shown in FIG. 11 provide information regarding the density of calcium deposits such that a catheter-based information module may respond accordingly in a treatment plan generated thereby. That is, the calcium density or hardness of the calcium deposits may be shown in an X-ray image as seen in FIG. 11 based on the gray-scale output of the X-rays. Based on one or more images such as those shown in FIG. 11, a catheter-based information module may determine, i.e., modify, or optimize, the energy applied to such calcium deposits. For example, the catheter-based information module may generate a treatment plan to apply a lower pressure in a catheter-based procedure based on an image depicting smaller diameter calcium deposits. Similarly, ultrasound images may be used to measure vascular strain, and such strain measurements may be applied by a catheter-based information module to help configure, e.g., the magnitude of the force applied during a catheter-based procedure or some other treatment configuration. In some cases, intravascular ultrasound images may be used to determine differences in strain across different locations within a blood vessel. Such differences in the characteristics of different locations of the blood vessel may be applied by a catheter-based information module to help configure, e.g., the magnitude of the force applied during a catheter-based procedure or some other treatment configuration.

[0146] Notwithstanding the appended claims, the present disclosure also is defined by the following clauses. 1. Performing a catheter-based procedure and communicating data regarding the catheter-based procedure to and / or from a catheter-based procedure information module, a method comprising. 2. The method according to clause 1, wherein the catheter-based treatment information module is a remote module. 3. The method according to any one of the preceding clauses, wherein the catheter-based treatment information module is configured to store data related to catheter-based treatment. 4. The method according to clause 3, wherein the catheter-based treatment information module comprises distributed data storage. 5. The method according to clause 3 or 4, wherein the catheter-based treatment information module comprises cloud-based data storage. 6. The method according to any one of the preceding clauses, wherein the catheter-based treatment information module is configured to receive and / or transmit data related to a plurality of catheter-based treatments. 7. The method according to clause 6, wherein at least two of the plurality of catheter-based treatments are performed at different locations. 8. The method according to clause 7, wherein the different locations include different catheter-based treatment locations. 9. The method according to any one of the preceding clauses, wherein the data related to catheter-based treatment communicated to the catheter-based treatment information module includes pre-treatment data. 10. The method according to clause 9, wherein the pre-treatment data includes data collected before performing the catheter-based treatment. 11. The method according to clause 9 or 10, wherein the pre-treatment data includes pre-treatment imaging. 12. The method according to clause 11, wherein the pre-treatment imaging includes angiography imaging, computed tomography imaging, optical coherence tomography, intravascular ultrasound imaging, or echocardiogram imaging. 13. The method according to any one of clauses 9 to 12, wherein the pre-treatment data includes pre-treatment vital signs. 14. The method according to clause 13, wherein the pre-treatment vital signs include body temperature, pulse rate, or respiratory rate. 15. The method according to any one of clauses 9 to 14, wherein the pre-treatment data includes pre-treatment measurements. 16. The method according to clause 15, wherein the pre-treatment measurements include ventricular pressure, aortic pressure, or electrocardiogram. 17. The method according to any of the preceding clauses, wherein data regarding a catheter-based treatment communicated to a catheter-based treatment information module includes in-treatment data. 18. The method according to clause 17, wherein the in-treatment data includes data collected during a catheter-based treatment. 19. The method according to clause 17 or 18, wherein the in-treatment data includes catheter system sensor data. 20. The method according to clause 19, wherein the catheter system sensor data includes balloon position, balloon deployment rate, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure above the valve, proximal pressure, distal pressure, or position of the valve within the annulus. 21. The method according to any of clauses 17 to 20, wherein the in-treatment data includes in-treatment imaging. 22. The method according to clause 21, wherein the in-treatment imaging includes angiographic imaging, computed tomography imaging, magnetic resonance imaging, optical coherence tomography, intravascular ultrasound imaging, or echocardiogram imaging. 23. The method according to any of clauses 17 to 22, wherein the in-treatment data includes in-treatment vital signs. 24. The method according to clause 23, wherein the in-treatment vital signs include body temperature, heart rate, or respiratory rate. 25. The method according to any of clauses 17 to 24, wherein the in-treatment data includes in-treatment measurements. 26. The method according to clause 25, wherein the in-treatment measurements include ventricular pressure, atrial pressure, aortic pressure, pressure within the coronary artery, or arterial pressure within another blood vessel, or an electrocardiogram. 27. The method according to any of the preceding clauses, wherein data regarding a catheter-based treatment communicated to a catheter-based treatment information module includes post-treatment data. 28. The method according to clause 27, wherein the post-treatment data includes data collected after performing a catheter-based treatment. 29. The method according to clause 27 or 28, wherein the post-treatment data includes catheter system sensor data. 30. The method according to clause 29, wherein the catheter system sensor data includes balloon position, balloon deployment rate, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure, or the position of the valve within the valve annulus. 31. The method according to any one of clauses 27 - 30, wherein the post-treatment data includes post-treatment imaging. 32. The method according to clause 31, wherein the post-treatment imaging includes angiographic imaging, computed tomography imaging, optical coherence tomography, magnetic resonance imaging, intravascular ultrasound imaging, or echocardiogram imaging. 33. The method according to any one of clauses 27 - 32, wherein the post-treatment data includes post-treatment vital signs. 34. The method according to clause 32, wherein the post-treatment vital signs include body temperature, heart rate, or respiratory rate. 35. The method according to any one of clauses 27 - 34, wherein the post-treatment data includes post-treatment measurements. 36. The method according to clause 34, wherein the post-treatment measurements include ventricular pressure, aortic pressure, or electrocardiogram. 37. The method according to any one of clauses 27 - 34, wherein the post-treatment data includes outcome information. 38. The method according to clause 37, wherein the outcome information includes data regarding acute valve opening, valve extensibility, intravascular pressure, or external pressure. 39. The method according to any of the preceding clauses, further comprising configuring a catheter-based treatment at least partially based on data communicated from a catheter-based treatment information module. 40. The method according to any of the preceding clauses, wherein the catheter-based treatment information module is configured to implement a treatment plan generation algorithm. 41. The method according to clause 40, wherein the treatment plan generation algorithm is configured to generate a treatment plan at least partially based on data regarding the catheter-based treatment communicated to the catheter-based treatment information module. 42. The method according to clause 41, wherein the data communicated from the catheter-based treatment information module includes a treatment plan. 43. The method according to any one of clauses 40 to 42, wherein the treatment plan includes the configuration of a catheter-based system for performing a catheter-based treatment. 44. The method according to clause 43, wherein the configuration of the catheter-based system includes a device type or a balloon type. 45. The method according to any one of clauses 40 to 44, wherein the treatment plan includes the configuration of a catheter-based treatment. 46. The method according to clause 45, wherein the configuration of the catheter-based treatment includes a treatment type, a treatment period, a treatment intensity, or a treatment frequency. 47. The method according to any one of clauses 40 to 46, wherein the treatment plan generation algorithm is configured to compare at least a subset of the data related to the catheter-based treatment with the data from a previous catheter-based treatment. 48. The method according to clause 47, wherein the treatment plan generation algorithm is configured to access a set of data related to a plurality of previous catheter-based treatments. 49. The method according to any one of clauses 40 to 46, wherein the treatment plan generation algorithm includes a machine learning algorithm. 50. The method according to clause 49, further comprising training the machine learning algorithm using the data related to the catheter-based treatment. 51. The method according to clause 49 or 50, further comprising training the machine learning algorithm using the data related to a plurality of previous catheter-based treatments. 52. The method according to clause 51, wherein the data related to the previous catheter-based treatments includes the data from the catheter-based locations where the treatments are performed at a plurality of locations. 53. The method according to any one of clauses 38 to 52, further comprising configuring a catheter-based treatment at least partially based on the treatment plan. 54. The method according to clause 53, wherein configuring the catheter-based treatment includes applying an initial configuration for the catheter-based treatment. 55. The method according to clause 53 or 54, wherein configuring the catheter-based treatment includes reconfiguring the catheter-based treatment during the performance of the catheter-based treatment. 56. The method according to any one of clauses 53 to 55, wherein configuring the catheter-based treatment includes selecting a treatment type, treatment duration, treatment intensity, or treatment frequency. 57. The method according to clause 56, wherein configuring the catheter-based treatment includes automatically adjusting the configuration of the catheter-based system. 58. The method according to clause 57, wherein configuring the catheter-based treatment includes presenting a change in the configuration of the catheter-based system for operator approval. 59. The method according to any of the preceding clauses, wherein the catheter-based treatment includes a method of applying pulsatile energy to a location of intraluminal tissue. 60. The method according to clause 59, wherein the catheter-based treatment includes applying a pulsatile balloon catheter system. 61. The method according to any one of clauses 1 to 58, wherein the catheter-based treatment includes a method of crossing a total occlusion. 62. The method according to clause 61, wherein the catheter-based treatment includes applying a microcatheter system for crossing a total occlusion. 63. The method according to any one of clauses 1 to 58, wherein the catheter-based treatment includes a method of applying pulsatile energy to heart valve tissue. 64. The method according to clause 63, wherein the catheter-based treatment includes applying a system for applying pulsatile energy to heart valve tissue. 65. The method according to any of the preceding clauses, wherein the catheter-based treatment is performed on a subject. 66. The method according to clause 65, wherein the subject is a mammal. 67. The method according to clause 66, wherein the subject is a human. 68. Comprising a catheter-based treatment information module, a catheter-based system, and an operable connection between the catheter-based treatment information module and the catheter-based system. The catheter-based treatment information module, comprises a first processor, the first processor comprising a memory operably coupled to the first processor, the memory including instructions stored therein which, when executed by the first processor, cause the first processor to receive data regarding catheter-based treatment from a catheter-based system, send data regarding catheter-based treatment to a catheter-based system, The catheter-based system comprises a catheter-based device and a second processor, the second processor comprising a memory operably coupled to the second processor, the memory including instructions stored therein which, when executed by the processor, cause the second processor to send data regarding catheter-based treatment to the catheter-based treatment information module, receive data regarding catheter-based treatment from the catheter-based treatment information module, and configure the catheter-based device based at least in part on data regarding catheter-based treatment received from the catheter-based treatment information module. A system. 69. The system according to clause 68, wherein the catheter-based treatment information module is remote from the catheter-based system. 70. The system according to clause 68 or 69, wherein the catheter-based treatment information module is configured to store data regarding catheter-based treatment. 71. The system according to clause 70, wherein the catheter-based treatment information module is configured to store data regarding catheter-based treatment in a distributed data storage. 72. The system according to clause 70 or 71, wherein the catheter-based treatment information module is configured to store data regarding catheter-based treatment in a cloud-based data storage. 73. The catheter-based system is a first catheter-based system, The catheter-based treatment information module is configured to receive data from a plurality of catheter-based systems and transmit data to the plurality of catheter-based systems, the system according to any one of clauses 68 to 72. 74. The system according to clause 73, wherein at least two of the plurality of catheter-based systems are located at different locations. 75. The system according to clause 74, wherein the different locations include different catheter-based treatment locations. 76. The system according to any one of clauses 68 to 75, wherein the data related to the catheter-based treatment transmitted to the catheter-based treatment information module includes pre-treatment data. 77. The system according to clause 76, wherein the pre-treatment data includes data collected before performing the catheter-based treatment. 78. The system according to clause 76 or 77, wherein the pre-treatment data is pre-treatment imaging. 79. The system according to clause 78, wherein the pre-treatment imaging includes angiography imaging, computed tomography imaging, optical coherence tomography, intravascular ultrasound imaging, or echocardiogram imaging. 80. The system according to any one of clauses 76 to 79, wherein the pre-treatment data includes pre-treatment vital signs. 81. The system according to clause 80, wherein the pre-treatment vital signs include body temperature, heart rate, or respiratory rate. 82. The system according to any one of clauses 76 to 81, wherein the pre-treatment data includes pre-treatment measurements. 83. The system according to clause 82, wherein the pre-treatment measurements include ventricular pressure, aortic pressure, or electrocardiogram. 84. The system according to any one of clauses 68 to 83, wherein the data related to the catheter-based treatment transmitted to the catheter-based treatment information module includes in-treatment data. 85. The system according to clause 84, wherein the in-treatment data includes data collected during the catheter-based treatment. 86. The catheter-based device includes a sensor, The system according to clause 84 or 85, wherein the data during treatment includes catheter-based device sensor data. 87. The system according to clause 86, wherein the catheter-based device sensor data includes balloon position, balloon deployment rate, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure above the valve, proximal pressure, distal pressure, or position of the valve within the annulus. 88. The system according to any one of clauses 84 to 87, wherein the data during treatment includes imaging during treatment. 89. The system according to clause 88, wherein the imaging during treatment includes angiographic imaging, computed tomography imaging, magnetic resonance imaging, optical coherence tomography, intravascular ultrasound imaging, or echocardiogram imaging. 90. The system according to any one of clauses 84 to 89, wherein the data during treatment includes vital signs during treatment. 91. The system according to clause 90, wherein the vital signs during treatment include body temperature, heart rate, or respiratory rate. 92. The system according to any one of clauses 84 to 91, wherein the data during treatment includes measured values during treatment. 93. The system according to clause 92, wherein the measured values during treatment include ventricular pressure, atrial pressure, aortic pressure, pressure within the coronary artery, or arterial pressure within another blood vessel, or an electrocardiogram. 94. The system according to any one of clauses 68 to 93, wherein the data related to the catheter-based treatment communicated to the catheter-based treatment information module includes post-treatment data. 95. The system according to clause 94, wherein the post-treatment data includes data collected after performing the catheter-based treatment. 96. The catheter-based device includes a sensor, The system according to clause 94 or 95, wherein the post-treatment data includes catheter-based device sensor data. 97. The system according to clause 96, wherein the catheter-based device sensor data includes balloon position, balloon deployment rate, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure above the valve, proximal pressure, distal pressure, or position of the valve within the annulus. 98. The system according to any one of clauses 94 to 97, wherein the post-treatment data includes imaging after treatment. 99. The system according to clause 98, wherein the post-treatment imaging includes angiographic imaging, computed tomography imaging, optical coherence tomography, magnetic resonance imaging, intravascular ultrasound imaging, or echocardiogram imaging. 100. The system according to any one of clauses 94 to 99, wherein the post-treatment data includes post-treatment vital signs. 101. The system according to clause 99, wherein the post-treatment vital signs include body temperature, heart rate, or respiratory rate. 102. The system according to any one of clauses 94 to 101, wherein the post-treatment data includes post-treatment measurement values. 103. The system according to clause 102, wherein the post-treatment measurement values include ventricular pressure, aortic pressure, or electrocardiogram. 104. The system according to any one of clauses 94 to 103, wherein the post-treatment data is outcome information. 105. The system according to clause 104, wherein the outcome information includes data related to acute valve opening, valve extensibility, intravascular pressure, or external pressure. 106. The system according to any one of clauses 68 to 105, wherein when the first processor memory is executed by the first processor, it further includes instructions for causing the first processor to apply a treatment plan generation algorithm. 107. The system according to clause 106, wherein the treatment plan generation algorithm is configured to generate a treatment plan based at least in part on data related to a catheter-based procedure received from a catheter-based system. 108. The system according to clause 107, wherein the data transmitted by the catheter-based treatment information module includes a treatment plan. 109. The system according to any one of clauses 106 to 108, wherein the treatment plan includes device type, balloon type, treatment type, treatment duration, treatment intensity, or treatment frequency. 110. The system according to any one of clauses 106 to 109, wherein the treatment plan generation algorithm is configured to compare at least a subset of the data related to the catheter-based procedure with data from a previous catheter-based procedure. 111. The system according to clause 110, wherein the treatment plan generation algorithm is configured to access a set of data regarding a plurality of previous catheter-based treatments. 112. The system according to any one of clauses 106 to 111, wherein the treatment plan generation algorithm includes a machine learning algorithm component. 113. The system according to clause 112, wherein the treatment plan generation algorithm further includes training the machine learning algorithm component using data regarding catheter-based treatments. 114. The system according to clause 112 or 113, wherein the treatment plan generation algorithm further includes training the machine learning algorithm component using data regarding a plurality of previous catheter-based treatments. 115. The system according to clause 114, wherein the data regarding previous catheter-based treatments includes data from catheter-based treatments performed at a plurality of locations. 116. The system according to any one of clauses 106 to 115, wherein configuring the catheter-based device at least partially based on the treatment plan includes configuring the catheter-based device at least partially based on data regarding catheter-based treatments received from the catheter-based treatment information module. 117. The system according to clause 116, wherein configuring the catheter-based device includes applying an initial configuration for the catheter-based treatment. 118. The system according to clause 116 or 117, wherein configuring the catheter-based device includes reconfiguring the catheter-based device. 119. The system according to any one of clauses 116 to 118, wherein configuring the catheter-based device includes selecting a treatment type, treatment duration, treatment intensity, or treatment frequency. 120. The system according to clause 119, wherein configuring the catheter-based device includes automatically adjusting the configuration of the catheter-based device. 121. The system of clause 120, wherein configuring the catheter-based device includes presenting a change in the configuration of the catheter-based device for operator approval. 122. The system of any one of clauses 68 - 121, wherein the catheter-based device comprises a pulsatile balloon catheter system. 123. The system of any one of clauses 68 - 121, wherein the catheter-based device comprises a microcatheter system for crossing total occlusions. 124. The method of any one of clauses 68 - 121, wherein applying the catheter-based device includes applying a system for imparting pulsatile energy to cardiac valve tissue. 125. A non-transitory computer-readable storage medium including instructions stored on the storage medium for communicating data regarding a catheter-based procedure to and / or from a catheter-based procedure information module, the instructions including an algorithm for receiving data regarding a catheter-based procedure from a catheter-based system, and an algorithm for transmitting data regarding a catheter-based procedure to a catheter-based system. 126. The non-transitory computer-readable storage medium of clause 125, further including an algorithm for storing data regarding a catheter-based procedure. 127. The non-transitory computer-readable storage medium of clause 125 or 126, wherein the algorithm for receiving data regarding a catheter-based procedure includes an algorithm for receiving data from a plurality of catheter-based systems, and the algorithm for transmitting data regarding a catheter-based procedure includes an algorithm for transmitting data to a plurality of catheter-based systems. A non - transitory computer - readable storage medium according to any one of clauses 125 - 127, wherein data related to a catheter - based treatment communicated from a catheter - based system includes pre - treatment data. A non - transitory computer - readable storage medium according to clause 128, wherein the pre - treatment data includes data collected before performing a catheter - based treatment. A non - transitory computer - readable storage medium according to clause 128 or 129, wherein the pre - treatment data includes pre - treatment imaging. A non - transitory computer - readable storage medium according to clause 130, wherein the pre - treatment imaging includes angiographic imaging, computed tomography imaging, optical coherence tomography, intravascular ultrasound imaging, or echocardiogram imaging. A non - transitory computer - readable storage medium according to any one of clauses 128 - 131, wherein the pre - treatment data includes pre - treatment vital signs. A non - transitory computer - readable storage medium according to clause 132, wherein the pre - treatment vital signs include body temperature, heart rate, or respiratory rate. A non - transitory computer - readable storage medium according to any one of clauses 128 - 133, wherein the pre - treatment data includes pre - treatment measurements. A non - transitory computer - readable storage medium according to clause 134, wherein the pre - treatment measurements include ventricular pressure, aortic pressure, or electrocardiogram. A non - transitory computer - readable storage medium according to any one of clauses 125 - 135, wherein data related to a catheter - based treatment communicated from a catheter - based system includes during - treatment data. A non - transitory computer - readable storage medium according to clause 136, wherein the during - treatment data includes data collected during a catheter - based treatment. A non - transitory computer - readable storage medium according to clause 136 or 137, wherein the pre - treatment data includes catheter system sensor data. 139. The non - transitory computer - readable storage medium according to clause 138, wherein the catheter system sensor data includes balloon position, balloon deployment rate, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure, or the position of the valve within the annulus. 140. The non - transitory computer - readable storage medium according to any one of clauses 136 - 139, wherein the during - treatment data includes during - treatment imaging. 141. The non - transitory computer - readable storage medium according to clause 140, wherein the during - treatment imaging includes angiographic imaging, computed tomography imaging, magnetic resonance imaging, optical coherence tomography, intravascular ultrasound imaging, or echocardiogram imaging. 142. The non - transitory computer - readable storage medium according to any one of clauses 136 - 141, wherein the during - treatment data includes during - treatment vital signs. 143. The non - transitory computer - readable storage medium according to clause 142, wherein the during - treatment vital signs include body temperature, heart rate, or respiratory rate. 144. The non - transitory computer - readable storage medium according to any one of clauses 136 - 143, wherein the during - treatment data includes during - treatment measurements. 145. The non - transitory computer - readable storage medium according to clause 144, wherein the during - treatment measurements include ventricular pressure, atrial pressure, aortic pressure, pressure in the coronary artery or arterial pressure in another blood vessel, or electrocardiogram. 146. The non - transitory computer - readable storage medium according to any one of clauses 125 - 145, wherein the data related to catheter - based treatment communicated from a catheter - based system includes post - treatment data. 147. The non - transitory computer - readable storage medium according to clause 146, wherein the post - treatment data includes data collected after performing a catheter - based treatment. 148. The non - transitory computer - readable storage medium according to clause 146 or 147, wherein the post - treatment data includes catheter system sensor data. 149. The non - transitory computer - readable storage medium according to clause 148, wherein the catheter system sensor data includes balloon position, balloon deployment rate, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure, or the position of the valve within the annulus. 150. A non - transitory computer - readable storage medium according to any one of clauses 146 - 149, wherein the post - treatment data includes post - treatment imaging. 151. A non - transitory computer - readable storage medium according to clause 150, wherein the post - treatment imaging includes angiography imaging, computed tomography imaging, optical coherence tomography, magnetic resonance imaging, intravascular ultrasound imaging, or echocardiogram imaging. 152. A non - transitory computer - readable storage medium according to any one of clauses 146 - 151, wherein the post - treatment data includes post - treatment vital signs. 153. A non - transitory computer - readable storage medium according to clause 152, wherein the post - treatment vital signs include body temperature, heart rate, or respiratory rate. 154. A non - transitory computer - readable storage medium according to any one of clauses 146 - 153, wherein the post - treatment data includes post - treatment measurement values. 155. A non - transitory computer - readable storage medium according to clause 154, wherein the post - treatment measurement values include ventricular pressure, aortic pressure, or electrocardiogram. 156. A non - transitory computer - readable storage medium according to any one of clauses 146 - 155, wherein the post - treatment data includes outcome information. 157. A non - transitory computer - readable storage medium according to clause 156, wherein the outcome information includes data related to acute valve opening, valve extensibility, intravascular pressure, or external pressure. 158. including stored instructions A non - transitory computer - readable storage medium according to any one of clauses 125 - 157, wherein the instructions further include an algorithm for generating a treatment plan. 159. A non - transitory computer - readable storage medium according to clause 158, wherein the algorithm for generating a treatment plan is configured to generate a treatment plan based at least in part on data related to a catheter - based procedure received from a catheter - based system. 160. A non - transitory computer - readable storage medium according to clause 159, wherein the algorithm for transmitting data related to a catheter - based procedure includes transmitting a treatment plan. 161. The non - transitory computer - readable storage medium according to any one of clauses 158 to 160, wherein the treatment plan includes the configuration of a catheter - based system for performing a catheter - based procedure. 162. The non - transitory computer - readable storage medium according to clause 161, wherein the configuration of the catheter - based system includes a device type or a balloon type. 163. The non - transitory computer - readable storage medium according to any one of clauses 158 to 162, wherein the treatment plan includes the configuration of a catheter - based procedure. 164. The non - transitory computer - readable storage medium according to clause 163, wherein the configuration of the catheter - based procedure includes a treatment type, a treatment period, a treatment intensity, or a treatment frequency. 165. The non - transitory computer - readable storage medium according to any one of clauses 158 to 164, wherein the algorithm for generating a treatment plan is configured to compare at least a subset of data related to a catheter - based procedure with data from a previous catheter - based procedure. 166. The non - transitory computer - readable storage medium according to clause 165, wherein the algorithm for generating a treatment plan is configured to access a set of data related to a plurality of previous catheter - based procedures. 167. The non - transitory computer - readable storage medium according to any one of clauses 158 to 166, wherein the algorithm for generating a treatment plan includes a machine - learning algorithm. 168. The non - transitory computer - readable storage medium according to clause 167, wherein the algorithm for generating a treatment plan is configured to train a machine - learning algorithm using data related to a catheter - based procedure. 169. The non - transitory computer - readable storage medium according to clause 167 or 168, wherein the algorithm for generating a treatment plan is configured to train a machine - learning algorithm using data related to a plurality of previous catheter - based procedures. 170. The non - transitory computer - readable storage medium according to clause 169, wherein the data related to a previous catheter - based procedure includes data from catheter - based procedures performed at a plurality of locations.

[0147] In at least some of the above embodiments, one or more elements used in one embodiment may be used interchangeably in another embodiment as long as replacement is technically feasible. Those skilled in the art should understand that various other omissions, additions, and modifications can be made to the above methods and structures without departing from the scope of the claimed subject matter. It is intended that all such modifications and changes fall within the scope of the subject matter defined by the appended claims.

[0148] Generally, the terms used in this specification and, in particular, in the appended claims (e.g., the body of the appended claims) are generally intended to be open terms (e.g., the term "including" should be construed as "including but not limited to", the term "having" should be construed as "having at least", the term "includes" should be construed as "includes but not limited to", etc.), as will be understood by those skilled in the art. Where a specific number of introduced claim recitations is intended, such intent will be expressly recited within the claims, and where no such recitation is present, it will be further understood by those skilled in the art that no such intent exists. For example, by way of illustration, the following appended claims may include the use of introductory phrases such as "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to mean that the introduction of a claim recitation by the indefinite article "a" or "an" limits a particular claim scope that includes such introduced claim recitation to embodiments that include only one such recitation. The same claim may include an introductory phrase such as "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" means "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim recitations. Additionally, even where a specific number of introduced claim recitations is expressly recited, those skilled in the art will recognize that such recitation should be construed to mean at least the recited number (e.g., a bare recitation of "two recitations" without other modifiers means at least two recitations, or two or more recitations).Furthermore, when a convention similar to "at least one of A, B, and C, etc." is used, generally, such a configuration is intended in the sense that a person skilled in the art would understand the convention (e.g., a system having at least one of A, B, and C includes, but is not limited to, a system having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C). When a convention similar to "at least one of A, B, or C, etc." is used, generally, such a configuration is intended in the sense that a person skilled in the art would understand the convention (e.g., a system having at least one of A, B, or C includes, but is not limited to, a system having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C). Regardless of the specification, claims, or drawings, it will be further understood by those skilled in the art that substantially any disjunctive and / or phrase presenting two or more alternative terms is to be understood as contemplating the possibility of including one of the terms, any of the terms, or both terms. For example, the phrase "A or B" would be understood to include the possibility of "A" or "B" or "A and B".

[0149] In addition, when a feature or aspect of the present disclosure is described from the perspective of a Markush group, thus, it will be recognized by those skilled in the art that the present disclosure is also described from the perspective of any individual member of the Markush group or any subgroup of the members.

[0150] As will be understood by those skilled in the art, for any and all purposes, including providing a written description, all ranges disclosed herein also include any and all possible sub-ranges, as well as combinations of such sub-ranges. Any recited range can be readily recognized as being such as to enable and provide for the range to be broken down into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, a middle third, and an upper third, etc. As will also be understood by those skilled in the art, all terms such as "greatest", "at least", "greater than", "less than", etc. include the recited number and refer to ranges that can later be broken down into sub-ranges as described above. Finally, as will be understood by those skilled in the art, a range includes each individual member. Thus, for example, a group having 1 to 3 articles refers to a group having 1, 2, or 3 articles. Similarly, a group having 1 to 5 articles refers to a group having 1, 2, 3, 4, or 5 articles, and so on.

[0151] While the above invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art that certain changes and modifications may be made to the inventions without departing from the spirit or scope of the appended claims in light of the teachings of the invention.

[0152] Accordingly, the foregoing merely illustrates the principles of the present invention. Those skilled in the art will appreciate that, although not explicitly described or illustrated herein, various arrangements embodying the principles of the present invention and falling within its spirit and scope can be devised. Further, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the present invention and the concepts contributed by the inventors to further the art and are to be construed as not being limited to such specifically recited examples and conditions. Moreover, all descriptions herein of the principles, aspects, and embodiments of the present invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, such equivalents are intended to include both currently known equivalents and equivalents developed in the future, i.e., any elements developed to perform the same function regardless of structure. Further, nothing disclosed herein is intended to be dedicated to the public whether or not such disclosure is explicitly recited in the claims.

[0153] Accordingly, it is not intended that the scope of the present invention be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the present invention are embodied by the appended claims. In the claims, 35 U.S.C. § 112(f) or 35 U.S.C. § 112(6) is expressly defined as being cited for a limitation in the claims only when the exact phrase "means for" or the exact phrase "step for" is recited at the beginning of such limitation in the claims, and 35 U.S.C. § 112(f) or 35 U.S.C. § 112(6) is not cited when such exact phrase is not used for a limitation in the claims.

[0154] Cross - Reference to Related Applications This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 63 / 346,704, filed May 27, 2022, under 35 U.S.C. § 119(e), and the entire disclosure of that application is incorporated herein by reference.

Claims

Claim 1 Performing a catheter-based procedure; and Communicating data regarding the catheter-based procedure to and / or from a catheter-based procedure information module, A method. Claim 2 The method according to claim 1, wherein the catheter-based procedure information module is a remote module. Claim 3 The method according to any one of the preceding claims, wherein the catheter-based procedure information module is configured to store data regarding the catheter-based procedure. Claim 4 The method according to any one of the preceding claims, wherein the catheter-based procedure information module is configured to receive and / or transmit data regarding a plurality of catheter-based procedures. Claim 5 The method according to claim 4, wherein at least two of the plurality of catheter-based procedures are performed at different locations. Claim 6 The method according to any one of the preceding claims, wherein the data regarding the catheter-based procedure communicated to the catheter-based procedure information module includes pre-treatment data. Claim 7 The method according to any one of the preceding claims, wherein the data regarding the catheter-based procedure communicated to the catheter-based procedure information module includes during-treatment data. Claim 8 The method according to any one of the preceding claims, wherein the data regarding the catheter-based procedure communicated to the catheter-based procedure information module includes post-treatment data. Claim 9 The method according to any one of the preceding claims, further comprising configuring the catheter-based procedure at least partially based on data communicated from the catheter-based procedure information module. Claim 10 The method according to any one of the preceding claims, wherein the catheter-based procedure information module is configured to implement a treatment plan generation algorithm. Claim 11 The method according to claim 10, wherein the treatment plan generation algorithm is configured to generate a treatment plan at least partially based on data regarding the catheter-based procedure communicated to the catheter-based procedure information module. Claim 12 The method of claim 11, wherein the treatment plan includes a configuration for a catheter-based system for performing the catheter-based procedure.

13. The method of claim 11 or 12, wherein the treatment plan generation algorithm is configured to compare at least a subset of data regarding the catheter-based procedure with data from previous catheter-based procedures.

14. The method of claim 13, wherein the treatment plan generation algorithm is configured to access a set of data regarding a plurality of previous catheter-based procedures.

15. A catheter-based treatment information module, a catheter-based system, and an operable connection between the catheter-based treatment information module and the catheter-based system, wherein the catheter-based treatment information module comprises a first processor, the first processor comprises a memory operably coupled to the first processor, the memory contains instructions stored therein, and when the instructions are executed by the first processor, the first processor is caused to receive data regarding a catheter-based procedure from the catheter-based system, send data regarding a catheter-based procedure to the catheter-based system, wherein the catheter-based system comprises a catheter-based device and a second processor, the second processor comprises a memory operably coupled to the second processor, the memory contains instructions stored therein, and when the instructions are executed by the second processor, the second processor is caused to send data regarding the catheter-based procedure to the catheter-based treatment information module, receive data regarding the catheter-based procedure from the catheter-based treatment information module, configure the catheter-based device based at least in part on the data regarding the catheter-based procedure received from the catheter-based treatment information module, system.

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