Systems and methods related to catheter-based procedures

Abstract

Methods and systems related to catheter-based procedures are provided. Aspects of a 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. Further, aspects of the systems of embodiments of the present invention include a catheter-based surgical information module, a catheter-based system, and an operable connection between the catheter-based surgical information module and the catheter-based system, wherein the catheter-based surgical information module and the catheter-based system transmit and receive surgery and conditions for catheter-based therapy to and from each other.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority under 35 USC § 119(e) to the filing date of U.S. Provisional Patent Application Serial No. 63 / 346,704, filed on May 27, 2022, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Cardiovascular tissue is susceptible to atherosclerotic plaques formed by a mechanism known as atherosclerosis, which is a buildup of fat and calcified material that can lead to stenosis, narrowing of the arterial lumen, or malfunction of heart valves. Catheter-based procedures, such as deployment of catheter-based systems (such as angioplasty balloons) via a catheter, are important techniques for addressing such disease conditions in cardiovascular tissue or other tissues affected by disease conditions that result in narrowing of the lumen of tissue. Certain catheter-based procedures involve deployment of catheter-based systems that are configured to apply pulsed energy to tissue (such as cardiovascular tissue), such as via a balloon. Such procedures and systems may be configured based on a number of different parameters, including the frequency of the pulsed energy applied to the tissue, the amount of pressure applied to the tissue by the pulsed energy, the number of pulses of the pulsed energy applied to the tissue, the duty cycle of the pulsed energy applied 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 with physiological conditions (e.g., the cardiac cycle), or, for example, staggering the application of pulsed energy and static pressure to the tissue. Existing treatments involving such catheter-based procedures and systems may rely solely on operator decisions or judgment regarding configuration of such procedures or systems, and as such may lack the ability to easily and adequately account for past performance and prior learning from similar or similar catheter-based procedures (e.g., procedures performed at different treatment centers and / or on different subjects). Summary of the invention

[0004] Thus, there remains a need for improved configuration and control of catheter-based therapeutic procedures and methods of performing catheter-based procedures, including configuration and control related to initiating treatment (i.e., automatically generating initial configuration settings) or dynamically adjusting aspects of treatment (i.e., automatically generating revised configuration settings for adjusting settings on the fly during treatment based on feedback obtained in real time or near real time during treatment). For example, methods and systems for identifying and presenting for operator approval and / or modification (i.e., enabling an operator of a catheter-based system to accept the presented automatically generated configuration, or, alternatively, to adjust one or more aspects of the automatically generated configuration prior to applying such configuration settings), configuration settings for catheter-based procedures may improve the effectiveness of such procedures, including, for example, between multiple different subjects at multiple different treatment locations. In addition, such methods and systems may improve the safety of performing catheter-based procedures, for example, by terminating catheter-based procedures prior to device or tissue failure.

[0005] The methods and systems of the present invention can identify configuration settings for catheter-based surgeries by utilizing data about historical catheter-based surgeries, so that subsequent catheter-based surgeries are informed based on such previous surgeries. The methods and systems of the present invention can be configured to provide a centralized repository of such surgery-based data, so that catheter-based surgeries performed on multiple different subjects at multiple different locations can access the same extensive data set of historical results of catheter-based surgeries. The methods and systems of the present invention can directly configure a catheter-based surgery or system based on automatically generated configuration settings, or can interact with an operator of a catheter-based system by, for example, presenting a suggested initial or revised configuration of a catheter-based surgery or system for approval or modification by the operator of the catheter-based system before applying the catheter-based surgery or catheter-based system.

[0006] Aspects of the method of an embodiment of the present invention include performing a catheter-based surgery and transmitting data about the catheter-based surgery to and / or from a catheter-based surgery information module. The catheter-based surgery information module may be a remote module. A system including a first processor is also provided, the first processor including a memory operably coupled to the first processor, wherein the memory includes instructions stored thereon, which when executed by the first processor causes the first processor to: receive data about the catheter-based surgery from the catheter-based system; and transmit data about the catheter-based surgery to the catheter-based system. The system of an embodiment of the present invention also includes a catheter-based system, the catheter-based system including: a catheter-based device; a second processor, the second processor including a memory operably coupled to the second processor, wherein the memory includes instructions stored thereon, which when executed by the second processor causes the second processor to: transmit data about the catheter-based surgery to the catheter-based surgery information module; receive data about the catheter-based surgery from the catheter-based surgery information module; and configure the catheter-based device based at least in part on the data about the catheter-based surgery received from the catheter-based surgery information module. The system of an embodiment of the present invention also includes an operable connection between the catheter-based surgery information module and the catheter-based system. In addition, a non-transitory computer-readable storage medium configured to perform the method described herein is provided. The method, system, and non-transitory computer-readable storage medium are used in a variety of different applications, including balloon angioplasty applications or other catheter-based surgeries, therapies, or treatments. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 A schematic diagram of a catheter-based system for applying pulsed energy to cardiovascular tissue for use in conjunction with embodiments of the methods and systems of the present invention is provided.

[0008] Figure 2 A flow chart illustrating a method associated with catheter-based surgery according to an embodiment of the present invention is provided.

[0009] Figure 3 Schematic diagrams of a control system for a catheter-based system and an interface with outputs of a catheter-based surgical information module, the outputs including a treatment plan, are provided.

[0010] Figure 4 A schematic diagram depicting a robotic approach for delivering therapeutic energy to diseased tissue from a control room.

[0011] Figure 5 Pressure-volume curves of tissue before and after catheter-based surgery are depicted.

[0012] Fig. 6A and Figure 6B Examples of measurements of changes in tissue compliance obtained during catheter-based procedures are provided.

[0013] Figure 7 Two examples of experimentally measured pressures in balloons used in catheter-based procedures and the forces output from such balloons are provided.

[0014] Figure 8 is a graph illustrating control of a catheter-based procedure to ensure the balloon is deflated to within a desired pressure range as the oscillation frequency (or pressure differential) of a balloon used in the catheter-based procedure is changed in accordance with principles of the present teachings.

[0015] Fig. 9 Exemplary images of calcification in luminal tissue before and after application of the catheter-based procedure of the present invention are presented.

[0016] Fig.10 Tables summarizing the expected effects of certain catheter-based procedures in different settings are presented.

[0017] Fig.11 X-ray images of calcium deposits are provided. DETAILED DESCRIPTION

[0018] Methods related to catheter-based surgery are provided. Aspects of the methods of embodiments of the present invention include performing a catheter-based surgery and transmitting data about the catheter-based surgery to and / or from a catheter-based surgery information module. The catheter-based surgery information module may be a remote module. A system including a first processor is also provided, the first processor including a memory operably coupled to the first processor, wherein the memory includes instructions stored thereon, which when executed by the first processor causes the first processor to: receive data about the catheter-based surgery from a catheter-based system; and transmit data about the catheter-based surgery to the catheter-based system. The system of an embodiment of the present invention also includes a catheter-based system, the catheter-based system including: a catheter-based device; a second processor, the second processor including a memory operably coupled to the second processor, wherein the memory includes instructions stored thereon, which when executed by the second processor causes the second processor to: transmit data about the catheter-based surgery to the catheter-based surgery information module; receive data about the catheter-based surgery from the catheter-based surgery information module; and configure the catheter-based device based at least in part on the data about the catheter-based surgery received from the catheter-based surgery information module. The system of the embodiment of the present invention also includes an operable connection between the catheter-based surgery information module and the catheter-based system. In addition, a non-transitory computer-readable storage medium configured to perform the method described herein is provided. The method, system and non-transitory computer-readable storage medium are used in a variety of different applications, including balloon angioplasty applications or other catheter-based surgeries, therapies or treatments.

[0019] Before describing the present invention in more detail, it should be understood that the present invention is not limited to the specific embodiments described, as such may of course vary. It should also be understood that the terminology used herein is for the purpose of describing specific embodiments only, and is not intended to be limiting, as the scope of the present invention is limited only by the appended claims.

[0020] Where a numerical range is provided, it is understood that unless the context clearly indicates otherwise, each intermediate value to the tenth lower limit unit between the upper and lower limits of the range and any other stated value or intermediate value in the range is encompassed within the present invention. The upper and lower limits of these smaller ranges may be independently included in the smaller ranges and are also encompassed within the present invention, but are subject to any explicitly excluded limitations in the ranges. Where the range includes one or both of the limitations, ranges excluding either or both of those included limitations are also encompassed within the present invention.

[0021] Certain ranges are presented herein with numerical values ​​preceded by the term "about." The term "about" is used herein to provide literal support for the exact number that follows it, as well as a number that is close to or approximately the number that follows the term. In determining whether a number is close to or approximately a specifically recited number, a close or approximate unrecited number may be a number that, in the context in which the number is given, provides a substantial equivalence to the specifically recited number.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described.

[0023] All publications and patents cited in this specification are incorporated herein by reference as if each individual publication or patent was specifically and individually indicated to be incorporated by reference and is incorporated herein by reference to disclose and describe the methods and / or materials related to the cited publication. The citation of any publication is due to its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

[0024] It should be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should also be noted that the claims can be drafted to exclude any optional elements. As such, this statement is intended to serve as antecedent basis for use of special terminology such as "solely," "only," etc. in connection with the recitation of claim elements, or use of a "negative" limitation.

[0025] It will be apparent to those skilled in the art after reading this disclosure that each of the various embodiments described and illustrated herein has discrete components and features that can be easily separated or combined with the features of any of the other several embodiments without departing from the scope or spirit of the invention. Any enumerated method can be performed in the order of the enumerated events or in any other order that is logically possible.

[0026] Although the apparatus and methods have been or will be described using functional interpretations for grammatical fluency, it should be clearly understood that unless expressly stated pursuant to 35 USC §112, the claims should not be interpreted as necessarily being limited in any way to constructions of “means” or “step” limitations, but should be given the full meaning and scope of the definitions set forth in the claims under the doctrine of judicial equivalents, and to the extent the claims are expressly set forth pursuant to 35 USC §112, they should be given the full legal equivalent meaning pursuant to 35 USC §112.

[0027] In further describing various aspects of the present invention, embodiments of methods are first described in more detail, followed by a review of embodiments of systems and non-transitory computer-readable storage media for practicing the subject methods.

[0028] method

[0029] As described above, methods related to catheter-based surgery are provided. Embodiments of the methods of the present invention include performing a catheter-based surgery and transmitting data about the catheter-based surgery to and / or from a catheter-based surgery information module. In an embodiment, the catheter-based surgery information module is a remote module. For example, the catheter-based surgery information module may be located in a different room, city, or country than where the catheter-based surgery is performed. In other embodiments, the data about the catheter-based surgery transmitted to and / or from the catheter-based surgery information module includes one or more of pre-treatment data, treatment period data, or post-treatment data, as described below.

[0030] The methods of the present invention are used for a variety of applications, including angioplasty applications or other catheter-based therapies or treatments, such as the treatment of heart valve disease. In some instances, the methods can be used to disrupt hardened material (e.g., calcium deposits) embedded in cardiovascular tissue (e.g., heart valve leaflets or heart valve commissures or other cardiovascular tissue). Specifically, the methods of embodiments of the present invention can be used to perform catheter-based procedures, including, for example, using the results of previously performed catheter-based procedures to better inform the configuration applied when performing subsequent catheter-based procedures, including performing on the same or different subjects at the same or different treatment locations. The present disclosure describes the application of embodiments related to treating tissue (such as cardiovascular tissue), related to, for example, calcification and / or deposits within tissue (such as cardiovascular tissue, such as a heart valve or features thereof or tissue supporting a heart valve). However, the present systems and teachings are not limited to catheter-based procedures for treating cardiovascular tissue associated with calcification, and can generally be applied to other applications determined by those skilled in the art.

[0031] The method can be used in conjunction with performing catheter-based procedures on any number of different subjects. In some instances, the subject is a "mammal" or "mammal," where these terms are broadly used to describe organisms in the class Mammalia, including the order Carnivora (e.g., dogs and cats), the order Rodents (e.g., mice, guinea pigs, and rats), and primates (e.g., humans, chimpanzees, and monkeys). In some instances, the subject is a human.

[0032] Catheter-based surgery information module:

[0033] Embodiments of the methods of the present invention include transmitting data regarding a catheter-based procedure to and / or from a catheter-based procedure information module. As such, in embodiments, the catheter-based procedure information module may function in a manner similar to a controller, thereby receiving data regarding a catheter-based procedure and / or transmitting configurations or settings for performing a catheter-based procedure, such as configurations or settings selected to automate or improve the effectiveness of a catheter-based procedure.

[0034] In an embodiment, the catheter-based information module may include a processor with a memory configured to transmit data about the catheter-based surgery. Although a specific processor (or other computer hardware) is not required to practice the present invention, the processor of interest may include a general-purpose processor, a graphics processing unit, a system on a chip, a microcontroller, etc., such as processors commercially available from AMD, ARM, Broadcom, Intel, Motorola, Nvidia, Qualcomm, Texas Instruments, etc. In some cases, the catheter-based information module may include more than one processor interconnected via an interconnection network, etc. The memory may be any suitable device in which the processor can store and retrieve data, such as a magnetic, optical or solid-state storage device (including a magnetic disk or optical disk or tape or RAM, or any other suitable fixed or portable device).

[0035] In an embodiment, any convenient means of communicating with or from a catheter-based surgery information module may be employed. In some cases, the catheter-based surgery information module is operably connected to a catheter-based system for performing a catheter-based surgery. That is, the catheter-based surgery information module may be directly or indirectly coupled to a catheter-based system for performing a catheter-based surgery. In other cases, the catheter-based surgery information module and / or the catheter-based system for performing a catheter-based surgery 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.

[0036] 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 communications (GSM)). In some cases, the communication interface may employ an I2C communication protocol, i.e., an inter-integrated circuit communication protocol, for example, over a bus (such as a serial bus thereof). In some cases, the communication interface of interest may be a communication interface designed to reduce or minimize wire count, such as wire count between integrated circuits or wire count of a catheter-based system for performing catheter-based surgery.

[0037] In one embodiment, the communications interface is configured to include one or more communications ports, such as physical ports or interfaces (such as a USB port, an RS-232 port, or any other suitable electrical connection port) to allow data communications to and / or from the catheter-based surgery information module and other external devices, such as a catheter-based system for performing catheter-based surgery or a computer terminal configured for similar supplemental data communications (e.g., at a control room).

[0038] 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 surgery information module to communicate with other devices, such as a catheter-based system for performing catheter-based surgery, a computer terminal and / or network, a communication-enabled mobile phone, a personal digital assistant, or any other communication device that may be used in conjunction with the catheter-based surgery information module.

[0039] In one embodiment, the communication interface is configured to provide a data transfer connection using Internet Protocol (IP) through a cellular telephone network, a 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.

[0040] In one embodiment, the catheter-based surgical information module is configured to communicate wirelessly with a server device via a communication interface, for example, using a common standard such as 802.11 or Bluetooth® RF protocol or IrDA infrared protocol. Such a server device can be a portable device such as a smart phone, a personal digital assistant (PDA), or a laptop; 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 an input device (such as a button, a keyboard, a mouse, or a touch screen).

[0041] In some embodiments, the communication interface is configured to automatically or semi-automatically communicate data stored in the catheter-based surgical information module, such as data stored in an optional data storage unit, with a network or server device using one or more of the above-described communication protocols and / or mechanisms.

[0042] In an embodiment, the catheter-based surgery information module is a remote module. "Remote module" means that the catheter-based surgery information module is removed at a distance from the location where the catheter-based surgery is performed. That is, the catheter-based information module can be separated from the catheter device involved in performing the catheter-based surgery, that is, a separate physical and / or logical device. For example, the catheter-based surgery information module can be a module separated from the catheter device (catheter-based system) used in conjunction with performing the catheter-based surgery, and the catheter-based surgery information module can be located in different parts of different partitions of, for example, a treatment room or an operating room, such as outside the sterile area where the catheter-based surgery is performed or behind a barrier (such as a curtain or lead shielding, etc.). In other examples, the catheter-based surgery information module can be located in different rooms of the same building, such as, for example, a control room of a hospital or treatment center. In other cases, the catheter-based surgery information module can be located in a building or city or country different from the one where the catheter-based surgery is performed, that is, at any convenient distance, for example, as required by the constraints and / or configuration of the catheter-based surgery information module and the catheter-based surgery.

[0043] In an embodiment, the catheter-based surgery information module is configured to store data about catheter-based surgery. The catheter-based surgery information module can be configured to store any data related to catheter-based surgery, such as, for example, pre-treatment data, treatment period data, and post-treatment data as described herein. Such data can be stored in a manner or format that makes the data easily accessible, such as for analysis or as input to an algorithm, such as an artificial intelligence algorithm, such as a machine learning algorithm or a neural network algorithm or a deep learning algorithm or a convolutional neural network algorithm, which is configured to generate settings and / or configurations for catheter-based surgery, as described herein. Such data can be stored in a manner or format that facilitates such analysis, such as in a database format or other data structure format, so that data about different catheter-based surgeries are stored in a unified and / or predictable manner, so that they can be accessed at any time as needed. For example, data about catheter-based surgery can be stored in a manner that enables such data to be accessed by more than one catheter-based surgery information module, for example, different catheter-based surgery information modules present in different control rooms of different treatment centers, such as, for example, stored in a distributed memory or a cloud-based memory, etc.

[0044] In some embodiments, the memory of the catheter-based surgery information module can be configured to store such data, and / or the catheter-based surgery information module can be configured to store such data in a separate external memory, including, for example, an external memory attached via a network connection, such as a distributed data memory or a cloud-based memory, i.e., where the data is stored at more than one node of a computer network and / or distributed in a logically continuous manner on physically separate storage devices, including, for example, separate locations interconnected via a computer network. 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, 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, for example, the Health Insurance Portability and Accountability Act of 1996 (HIPPA) related to the storage of medical data in the United States.

[0045] In an embodiment, the catheter-based surgery information module may be configured to receive and / or transmit data about a plurality of catheter-based surgeries. In some cases, the catheter-based surgery information module may be configured to receive and / or transmit data about a first catheter-based surgery at a first time and a second catheter-based surgery at a second time. As such, the catheter-based surgery information module may be configured to receive and / or transmit data about catheter-based surgeries occurring within any desired time span, such as surgeries occurring within a day or more, such as surgeries occurring within a month or more, or within a year or more.

[0046] In other cases, the catheter-based surgery information module may be operably connected to more than one catheter-based system, i.e., a system for performing a catheter-based surgery, e.g., via a computer network as described above, etc. In these cases, the catheter-based surgery information module may receive and / or transmit data about more than one catheter-based treatment substantially simultaneously. In an embodiment, different catheter-based procedures are performed at different locations (i.e., different treatment locations, such as different treatment rooms or operating rooms in a treatment center or hospital) or in different buildings (such as different treatment centers or different hospitals or in different cities or different countries).

[0047] In an embodiment, the catheter-based surgery information module is configured to receive, store and / or analyze data regarding any convenient number of catheter-based surgeries (i.e., data originating from any number of catheter-based surgeries) as desired, such as one or more, such as ten 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 surgeries.

[0048] Catheter-Based Procedure Data :

[0049] In embodiments, the data regarding the catheter-based surgery transmitted to and / or from the catheter-based surgery information module includes any available data related to the catheter-based surgery, and may vary as desired. In some cases, the data regarding the catheter-based surgery is data related to the purpose of, for example, generating configuration settings for the catheter-based surgery or other, for example, subsequently performed catheter-based surgery (including subsequent catheter-based surgery performed on different subjects) and / or analyzing its effectiveness.

[0050] In some embodiments, the data regarding the catheter-based surgery transmitted to and / or from the catheter-based surgery information module includes pre-treatment data or treatment period data or post-treatment data. "Pre-treatment data" refers to information available before the catheter-based surgery is performed; "treatment period information" refers to information available during the catheter-based surgery, i.e., data available when the catheter-based surgery is performed; and "post-treatment data" refers to information available after the catheter-based surgery is performed. As such, in embodiments, the pre-treatment data transmitted to and / or from the catheter-based surgery information module includes data collected before the catheter-based surgery is performed; the treatment period data transmitted to and / or from the catheter-based surgery information module includes data collected during the catheter-based surgery; and the post-treatment data transmitted to and / or from the catheter-based surgery information module includes data collected after the catheter-based surgery is performed.

[0051] Data about the catheter-based surgery transmitted to and / or from the catheter-based surgery information module may include imaging data, such as pre-treatment imaging, treatment imaging, and / or post-treatment imaging. The imaging data (such as pre-treatment imaging, treatment imaging, and / or post-treatment imaging) may include images showing one or more characteristics of the tissue on which the catheter-based surgery was performed. Such characteristics may include characteristics of diseased tissue, such as the presence, location, or extent of calcium deposits in cardiovascular tissue, such as calcification of heart valve commissures or leaflets, or other atherosclerotic tissue, such as blockages in luminal tissue, such as stenotic arteries, including chronic total occlusions. In embodiments, the imaging data (such as pre-treatment imaging, treatment imaging, and / or post-treatment imaging) include the results of any convenient imaging technique, and these may vary, such as, for example, angiographic imaging, computed tomography imaging, optical coherence tomography imaging, intravascular ultrasound imaging, echocardiography imaging, and the like. In other embodiments, the imaging data includes images of aspects of a system for performing catheter-based treatments, such as images of a catheter balloon present in luminal tissue or a cardiac tissue compliant element present in a heart valve, as described in U.S. Application Serial No. 63,346,703, entitled “Systems and Methods for Treating Cardiovascular Tissue” and filed on the same day (Attorney Docket No. AVSI-004PRV); the disclosure of which is incorporated herein by reference. In some cases, the imaging data includes annotated images of tissue, such as annotations indicating the location or extent of diseased tissue, and / or annotated images of components used in conjunction with the catheter-based procedure, such as, for example, images of a balloon attached to a catheter present in proximity to cardiovascular tissue, such as a heart valve having calcium deposits on its leaflets.

[0052] Data about the catheter-based surgery transmitted to and / or from the catheter-based surgery information module may also include vital signs, such as pre-treatment vital signs, treatment period vital signs, or post-treatment vital signs. Vital signs (such as pre-treatment vital signs, treatment period vital signs, or post-treatment vital signs) may include any available physiological characteristics of the subject, and this may vary, for example, depending on the nature of the diseased tissue, the subject's underlying condition, or the catheter-based surgery. Vital signs of interest include body temperature, pulse rate, and / or respiratory rate. Vital signs of interest may also include other physiological characteristics, such as blood pressure measurements, including systolic and / or diastolic blood pressure measurements, blood oxygen measurements (i.e., pulse oximeter readings), height or weight measurements, body composition information, other measurements, such as the distance between the catheter entry point (e.g., via the femoral artery) and the treatment site (e.g., the aortic heart valve), etc.

[0053] Data regarding the catheter-based procedure transmitted to and / or from the catheter-based procedure information module may also include other measurements, such as pre-treatment measurements, treatment period measurements, and / or post-treatment measurements. For example, such measurements may include results of ventricular pressure, aortic pressure, electrocardiogram, or blood volume measurements, or measurements of blood perfusion, such as perfusion of luminal tissue through an obstruction such as an arterial stenosis.

[0054] Data about catheter-based surgery transmitted to and / or from the catheter-based surgery information module may also include catheter system sensor data. Catheter system sensor data may include data collected by an aspect of a catheter system used in conjunction with performing catheter-based surgery. In an embodiment, the catheter system sensor data may include data collected from a sensor attached to or integrated with such a catheter system. In some cases, the 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, the catheter system sensor data may include balloon position, balloon deployment percentage, valve opening amount, valve eccentricity, perivalvular leakage, peripheral pressure on the valve, proximal pressure, distal pressure, or the position of the valve in the valve annulus.

[0055] Data about the catheter-based surgery transmitted to and / or from the catheter-based surgery information module may also include outcome information. Result information may refer to the outcome of the catheter-based surgery, and may include the outcome or any aspect of the outcome, such as the outcome changes in tissue properties in each case where the catheter-based surgery is completed, such as post-treatment compliance measurements or post-treatment measurements of heart valve function. In an embodiment, the outcome information includes data about acute valve opening, valve compliance (or other compliance metrics, such as vascular compliance based on measurements of pressure and volume changes), intravascular pressure, or external pressure. In some cases, the relevant 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 from a leg region (e.g., ankle) and an arm region of a subject via a blood pressure cuff. In other cases, the relevant pressure data includes pressure measurements obtained in the coronary arteries and aorta or left ventricle, including, for example, appropriate ratios of various pressures, such as diastolic gradients, waveless transient diastolic gradients, or hyperemic flow reserve fractions. The result information may include data collected from various aspects of the catheter system used to perform the catheter-based surgery, such as pressure or volume sensors integrated into the catheter system, such as volume sensors integrated into the connector of the catheter system (such as Hall sensors and magnets configured to measure changes in fluid volume). In other cases, the result information may include data collected from sensors and the like that are separate from and external to the catheter system used to perform the catheter-based surgery, such as, for example, imaging results or electrocardiogram results or echocardiogram results or measurements of fluid perfusion in certain tissue regions, etc. In embodiments, such sensors may be invasive or non-invasive. In some cases, the result information may include data collected from a mechanism configured to measure pressure across a lesion, such as, for example, measurements obtained by attaching a line to a distal region of a catheter configured to measure proximal and distal pressures across a lesion. In other cases, the result information may include fractional flow reserve (FFR) data. In embodiments configured to treat an aortic valve, the result information may be obtained using a pressure sensor configured to measure pressure on a treatment region (e.g., a catheter balloon present in a blood vessel). In embodiments, the sensor used to obtain the result information may include an optical fiber line attached to a distal region of the catheter. In yet other embodiments, the result information may include data collected by ultrasound or magnetic resonance imaging (MRI) or an optical imaging system configured to display the location of cardiac structures or changes in cardiac function or flow.

[0056] Data relating to a catheter-based procedure that is pre-treatment data, such as pre-treatment imaging or pre-treatment vital signs or pre-treatment measurements, can include data available at any time prior to the performance of the catheter-based procedure, such as, for example, pre-treatment data collected as part of a subject's pre-procedural workup that occurs, for example, on the day of the catheter-based procedure or substantially immediately prior to the performance of the catheter-based procedure, or data obtained one or more days prior to the performance of the catheter-based procedure, such as the results of an echocardiogram obtained at an earlier time at a separate, specialized treatment site.

[0057] Data relating to the catheter-based procedure is treatment period data, such as treatment period imaging or treatment period vital signs or treatment period measurements, including data available at any time during the catheter-based procedure, such as, for example, data collected substantially at the beginning of the catheter-based procedure, for example, when treatment is first applied through the catheter-based procedure, or at a later time as treatment continues through the catheter-based procedure. Examples of treatment period data include imaging data collected at regular intervals through the catheter-based procedure throughout the catheter-based procedure that depicts the position or orientation of an aspect of the catheter-based system used for the catheter-based procedure, or measurements of tissue compliance, i.e., indicating the extent of disruption of calcium deposits, collected at regular intervals, or collected upon the occurrence of a specified event (e.g., a change in pressure or volume greater than a specified threshold).

[0058] Data regarding the catheter-based procedure as post-treatment data, such as post-treatment imaging or post-treatment vital signs or post-treatment measurements, can include data available at any time after the catheter-based procedure is completed, such as, for example, data collected substantially immediately after the catheter-based procedure is completed, for example, after treatment is no longer being applied via the catheter-based procedure, or at a later time, such as one minute or more, one hour or more, one day or more, one week or more, after the catheter-based procedure is completed. Examples of post-treatment data include imaging data collected at regular intervals that depicts the position or orientation of an aspect of a catheter-based system used for the catheter-based procedure, or measurements of tissue compliance, i.e., indicating the extent of disruption of calcium deposits, or other measurements intended to measure an aspect of the subject's physiology affected by the disease condition, in each case collected at regular intervals throughout the catheter-based procedure.

[0059] Catheter-based surgical configuration :

[0060] Methods according to the present invention may also include configuring a catheter-based procedure based at least in part on data transmitted to and / or transmitted from a catheter-based procedure information module. For example, a catheter-based procedure information module may transmit (i.e., transfer) settings to a catheter system used in conjunction with performing a catheter-based procedure, wherein the settings reflect a specified configuration of the catheter system for applying the catheter-based procedure in a specified manner. Any potential settings or configurations may be transmitted from the catheter-based procedure information module, including but not limited to catheter balloon pressure, such as maximum pressure, balloon inflation frequency or duty cycle, total treatment time, total number of balloon pulses, specifications of any configuration change (i.e., change) over time (e.g., a configuration that the catheter balloon pressure will increase over time at a specified rate before decreasing over time at a specified rate), etc. In other cases, potential settings or configurations include settings related to hardware types, such as what type (e.g., size or other features or characteristics) of a catheter balloon or distal traverser unit or cardiac tissue compliance element or other aspects of a catheter or catheter-based system used to perform a catheter-based procedure should be applied when performing a catheter-based procedure. That is, the configurations or settings transmitted from the catheter-based surgery information module may include at least specifications for various aspects of a catheter system for performing catheter-based surgery, as well as settings regarding how to operate or control or manipulate such a catheter system in conjunction with performing the catheter-based surgery.

[0061] In embodiments, by "configuring the catheter-based procedure based at least in part on data transmitted to and / or from the catheter-based procedure information module" is meant that the catheter-based information module is configured to first receive information about the catheter-based procedure, and transmit information about configuring the catheter-based procedure based on such information. For example, the catheter-based procedure information module may receive information indicating that a catheter-based procedure is to be performed to address a diseased heart valve having certain tissue characteristics, and the catheter-based information module may transmit a configuration (i.e., configuration settings) that includes applying pulsed energy to the diseased tissue at a specified frequency and / or duty cycle and / or duration (e.g., time or total number of pulses), such that the catheter-based procedure is configured at least in part based on such configuration generated by and received from the catheter-based information module. Continuing with this example, the catheter-based procedure information module may subsequently receive information indicating a change in tissue compliance (e.g., heart valve compliance), and the catheter-based information module may further transmit (i.e., revised or updated) configuration settings, including applying pulsed 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 procedure is reconfigured based at least in part on such subsequent configuration from the catheter-based information module. In some cases, information regarding perfusion through an aspect of a catheter-based system used to perform a catheter-based procedure (e.g., an angioplasty balloon or a cardiac tissue compliant element, etc.) may be transmitted to and / or from the catheter-based information module such that a revised treatment plan is associated with improving perfusion through that aspect of the catheter-based system, for example, to prevent tissue damage due to reduced perfusion through the catheter-based system.

[0062] The catheter-based information module of an embodiment of the present invention may be configured to generate a treatment plan. In an embodiment, the catheter-based surgery 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 about the catheter-based surgery transmitted to the catheter-based surgery information module. In other cases, the data transmitted from the catheter-based surgery information module includes the treatment plan.

[0063] A "treatment plan" refers to any potential configuration associated with performing a catheter-based procedure, i.e., a setting for any configurable aspect of performing a catheter-based procedure. In an embodiment, a treatment plan includes one or more configurations, i.e., settings, of a catheter system for performing a catheter-based procedure. For example, a treatment plan may specify a device type, such as a type of catheter device, such as a catheter device capable of delivering pulsed energy, such as 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, a treatment plan may specify a balloon type, such as, for example, the size or shape or expansion volume or degree of compliance of a catheter balloon, or similar aspects of other related devices, such as a type of cardiac tissue compliance element (e.g., an aspect of a catheter system that is configured to deliver pulsed energy to a heart valve, such as a heart valve commissure or leaflet) or a distal crosser unit (e.g., an aspect of a catheter system that is configured to pass through a chronic total occlusion). In other cases, the treatment plan may specify other aspects of the catheter system used to perform the catheter-based procedure, such as specifying an electrical potential source, such as an electrical potential source comprising pressurized carbon dioxide, or specifying an oscillator type, such as an oscillator configured to produce pressure oscillations at a specified frequency, or specifying a connector type, such as a connector configured to convert a first pulse of energy into a second pulse of energy having a specified fluid displacement amount.

[0064] In other embodiments, the treatment plan includes a configuration for a catheter-based procedure. That is, in some cases, the treatment plan may specify how to use a catheter system to perform a catheter-based procedure. In some cases, the configuration for a catheter-based procedure includes a treatment type, a treatment duration, a treatment intensity, or a treatment frequency. The treatment type may include any desired catheter-based procedure, such as, for example, applying pulsed energy using a balloon catheter system, or applying pulsed energy to a heart valve using a cardiac tissue compliant element. Other examples of treatment types include applying static energy, such as static pressure, or any desired combination of static and dynamic energy, such as a combination of static pressure and pulsed pressure, to the tissue. Still other examples of treatment types include other treatments performed using catheter-based procedures known in the art, including, for example, applying energy to the tissue in the form of electrical pulses to generate cavitation bubbles, ultrasound, plasma bubbles, or other high-voltage pulses, or applying energy in the form of light or laser pulses to generate cavitation bubbles, ultrasound, plasma bubbles, or other high-voltage pulses, or applying energy in the form of heat or energy, such as for cryotherapy, i.e., applying heat or cold to the tissue. Treatment intensity may include any desired characteristics of how the type of treatment is applied, such as, for example, the pressure applied by the pulsed energy or the duration, such as the total time, that the pulsed energy is applied. Treatment frequency may include the pulse frequency or duty cycle at which the pulsed energy is applied.

[0065] In some cases, a treatment plan may be related to (i.e., may be based at least in part on and / or may provide guidance, such as configuration settings) aspects of a device deployed or implanted in a tissue, such as a stent. Treatment plan information is related to the deployment of the stent in the relevant tissue, the behavior of the stent in the relevant tissue, the response of the stent in the relevant tissue, the response of the relevant tissue to the placement of the stent, and / or the orientation of the stent in the relevant tissue. In other embodiments, a catheter-based procedure may include the installation of 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 influence and / or predict the desired behavior of a device (such as an implanted device). For example, in the case of a catheter-based procedure for deploying a stent, the treatment plan information may be related to predictions about how such a stent will respond when deployed, for example, whether it will jump forward when a self-expanding stent is used, or how the stent and vessel tortuosity will respond when the stent is deployed, or whether the stent will cause edge peeling, or whether the stent will expand completely or whether the vessel needs more preparation. In the case of a catheter-based procedure for deploying a replacement heart valve, treatment planning information may be related to predictions about how the replacement heart valve will position itself and function.

[0066] In some cases, the goal of a catheter-based procedure and therefore the corresponding treatment plan for such a catheter-based procedure is to apply a certain peak impulse force to the tissue around, for example, a balloon or cardiac tissue compliance element involved in performing the catheter-based procedure. Such impulse force can be varied based on, for example, the location of stenosis and radial calcium location within the tissue. The smaller the diameter of the tissue, the greater the force required to be applied to achieve the same effect, and the lower the pressure / energy. For calcium away from the center of the treated tissue (e.g., the lumen), a higher pressure is required to achieve the same force and stress in the calcium. In an embodiment, it is desirable to measure the diameter in situ by volume / diameter measurement (i.e., by a balloon), by optical coherence tomography (OCT), or by other imaging techniques (such as ultrasound imaging or fluorescence imaging or other external imaging techniques). Once measured, a treatment plan can be deployed based at least in part on such measurements so that a peak pressure is applied during the performance of the catheter-based procedure, and then adjusted so that the force / energy applied to the calcium by, for example, a balloon or cardiac tissue compliance element is always consistent. This example illustrates how embodiments of the present invention can be used to improve the safety of treatment, i.e., improve the safety of performing catheter-based surgery. For example, embodiments of the present invention include providing guidance and / or determining and / or controlling when to stop treatment. In some embodiments, a catheter-based surgery information module or a controller of a catheter-based system monitors a catheter-based surgery and can cause the termination of such surgery. For example, in the event that a catheter-based surgery information module or a controller of a catheter-based system determines that a balloon of a catheter-based system may rupture, an embodiment can stop the catheter-based surgery. In some cases, an embodiment is configured to reduce pressure, such as pressure applied to a balloon or cardiac tissue compliance element of a catheter-based surgery before calcium ruptures, so as to reduce peeling or reduce the energy of a pulse crossover, thereby minimizing tissue damage when not in contact with calcium.

[0067] In embodiments, the treatment plan generation algorithm may be configured to generate a treatment plan, i.e., a configuration setting for performing a catheter-based procedure, in any convenient manner, and this may vary. For example, the treatment plan generation algorithm may include a lookup algorithm, for example, similar to accessing a database, for example, querying the database based on any relevant aspects of the catheter-based procedure, such as, for example, 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 about the catheter-based procedure with data from previous catheter-based procedures. That is, the catheter-based information module may receive information about the catheter-based procedure, such as, for example, characteristics of the diseased tissue (e.g., tissue compliance) or acute valve opening or age or blood pressure measurements of the subject receiving the catheter-based treatment, and the treatment plan generation algorithm may compare at least a subset of such received information with data from previously performed catheter-based procedures. For example, the treatment plan generation algorithm may compare at least a subset of such received information with similar data from previously performed catheter-based procedures in order to find previously applied configurations or settings. In some embodiments, the treatment plan generation algorithm is configured to access data sets about multiple previous catheter-based procedures. Such a data set may include data received by the catheter-based information module regarding catheter-based surgeries and configuration settings applied in previously performed catheter-based surgeries. Such a data set may be organized so that data received by the catheter-based information module regarding previously performed catheter-based surgeries (including data such as measurements of tissue compliance or imaging data or assessments of diseased tissue, etc.) may be used as a key or index to access corresponding configuration data for the corresponding catheter-based surgery. In such embodiments, the treatment plan generation algorithm may be configured to use at least a subset of the data regarding the catheter-based surgery to look up previously used configuration data. Embodiments utilizing such a configuration may reapply a configuration that was successful in a previously performed catheter-based surgery for a catheter-based surgery.

[0068] In some cases, embodiments may include a treatment planning algorithm that is configured to extrapolate relevant configuration data, i.e., when data received by the catheter-based information module is not identical to data available in a data set regarding multiple prior catheter-based procedures. Any convenient extrapolation-based approach may be applied, such as linear extrapolation. For example, where data measurements (e.g., tissue compliance measurements) collected in conjunction with an anticipated or ongoing catheter-based procedure are at a midpoint between, for example, tissue compliance measurements of two previously performed catheter-based procedures, the treatment planning algorithm may generate a configuration setting for the anticipated or ongoing catheter-based procedure that reflects, for example, a midpoint between the corresponding settings of the two previously performed catheter-based procedures.

[0069] In an embodiment, a treatment plan generation algorithm may be configured to utilize a nonlinear approach to generate a treatment plan for a catheter-based procedure. In some cases, the treatment plan generation algorithm comprises a machine learning algorithm. That is, in an embodiment, the treatment plan algorithm may receive information about a catheter-based procedure, at least a subset of which may include input to a machine learning algorithm configured to generate a treatment plan. A "machine learning" algorithm refers to any convenient computer algorithm designed to automatically learn through experience. In an embodiment, a relevant machine learning algorithm may employ supervised learning, unsupervised learning, or reinforcement learning methods to generate a treatment plan. A relevant machine learning algorithm may employ regression and classification techniques to arrive at a treatment plan. In an embodiment, relevant experience for training such a learning algorithm may include, for example, specially constructed training data or previously collected configuration (i.e., settings) and / or data about (i.e., tissue compliance measurements or outcome information); that is, the training data may include any number of available pre-treatment data, treatment period data, and / or post-treatment data from any catheter-based procedure (such as one or more previously performed catheter-based procedures). 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., as such models and algorithms are known in the art. In other cases, a Gaussian algorithm (such as, for example, a Gaussian derivative filter algorithm) is applied to detect changes, such as changes in the measured values ​​transmitted to the catheter-based surgical information module, and a threshold limit is set for the occurrence (e.g., the occurrence of the measured value exceeding the threshold limit). Such an algorithm is described in detail in, for example, U.S. Patent No. 11,464,949 B2, the disclosure of which is incorporated herein by reference.

[0070] Embodiments of the method in which the treatment planning algorithm comprises a machine learning algorithm may further comprise training the machine learning algorithm with data regarding catheter-based procedures. In some cases, data regarding one or more previously performed catheter-based procedures may be used to train the machine learning algorithm. For example, tissue characteristics (e.g., initial or intermediate valve compliance) and / or outcome information (e.g., resulting valve compliance) and a corresponding treatment plan, i.e., configuration settings (e.g., device type or pulse energy pressure, frequency, duty cycle, or treatment duration (i.e., the time period or total number of balloon pulses applied to the tissue)) may be provided to the machine learning algorithm for use in training the machine learning algorithm to make predictions regarding an optimal or effective treatment plan. In embodiments, the data used to train the machine learning algorithm may comprise data from a plurality of previous catheter-based procedures. In some embodiments, such training data, i.e., data regarding previous catheter-based procedures, comprises data from catheter-based procedures performed at a plurality of locations, including two, three, four, five, six, seven, eight, nine, ten, 100, 1,000, 10,000, or more different locations. That is, the catheter-based information module can be configured (e.g., interconnected) to receive data about catheter-based surgery from multiple different locations. For example, the catheter-based information module can be configured (e.g., interconnected) to multiple different treatment locations, such as different treatment locations within a treatment center or different treatment centers, such as multiple hospitals. In an embodiment, such training data (i.e., data about previous catheter-based surgery) includes data from catheter-based surgery performed on multiple different subjects, such as one or more subjects, including two, three, four, five, six, seven, eight, nine, ten, 100, 1,000, 10,000 or more subjects. In other cases, synthetic data (i.e., data generated in addition to previously performed catheter-based surgery) can be used to train a machine learning algorithm. Such synthetic data can be generated in any convenient manner and can vary.

[0071] Applying treatment plans :

[0072] Embodiments of methods according to the present invention also include configuring a catheter-based surgery based at least in part on a treatment plan. That is, in an embodiment, the treatment plan includes settings or configurations for performing the catheter-based surgery. Configuring the catheter-based treatment plan includes applying such settings or configurations in conjunction with performing the catheter-based surgery. For example, the treatment plan may include frequency settings for applying pulsed energy to tissue. In such an example, applying such a treatment plan includes applying pulsed energy to tissue at a frequency setting specified in the treatment plan. In some cases, configuring the catheter-based surgery includes applying an initial configuration for the catheter-based surgery. That is, the treatment plan may specify one or more configurations or settings at which the catheter-based surgery may be initially performed. Such settings for the catheter-based surgery may remain unchanged throughout the duration of the catheter-based surgery, or may change based on subsequently obtained information, such as a response caused by the catheter-based treatment, such as a change in tissue compliance (or, in some cases, a lack of expected change) when the treatment plan is initially applied when performing the catheter-based surgery.

[0073] In some cases, configuring the catheter-based procedure includes reconfiguring the catheter-based procedure while the catheter-based procedure is being performed. That is, a treatment plan may specify one or more configurations or settings under which the catheter-based procedure may be performed after the catheter-based procedure has been initiated. In some cases, an initial treatment plan specifies a first set of configuration settings to be applied when the catheter-based therapy is initiated, and a subsequent treatment plan specifies a second set of configuration settings to be applied when the catheter-based procedure is performed. For example, the configuration of the catheter-based procedure may be changed or updated based on information obtained after the catheter-based procedure is initiated, such as a response caused by the catheter-based therapy, such as a change in tissue compliance (or the lack of an expected change), after the initial treatment plan was initially applied when the catheter-based procedure was performed.

[0074] In an embodiment, configuring a catheter-based procedure includes selecting, for example, a treatment type, a treatment duration, a treatment intensity, or a treatment frequency. Such configurations may be applied to the initial configuration or subsequent reconfiguration of a catheter-based procedure. In some embodiments, the treatment type may include any desired catheter-based procedure, such as, for example, the application of pulsed energy, for example, using a balloon catheter system or using a cardiac tissue compliance element to apply pulsed energy to a heart valve, or using a distal crossover unit to apply pulsed energy to a chronic total occlusion. Other examples of treatment types include applying static energy (e.g., static pressure) or any desired combination of static energy and dynamic energy (e.g., a combination of static pressure and pulsed pressure) to tissue. Still other examples of treatment types include other treatments performed using catheter-based procedures known in the art, including, for example, applying energy to tissue in the form of electrical pulses to generate cavitation bubbles, ultrasound, plasma bubbles, or other high-voltage pulses, or applying energy in the form of light or laser pulses to generate cavitation bubbles, ultrasound, plasma bubbles, or other high-voltage pulses, or applying energy in the form of heat or energy, for example, for cryotherapy (i.e., applying heat or cold to tissue).

[0075] In embodiments, treatment duration includes the amount of time that treatment is applied to tissue. In instances, treatment duration specifies the total treatment time and / or the amount of time that different aspects of treatment are applied to tissue. For example, in some cases, treatment duration specifies the amount of time static energy is applied to tissue and / or the amount of time tissue is allowed to rest and / or the amount of time pulsed energy is applied to tissue. In some cases, treatment duration includes one or more specific times corresponding to the duration of one or more aspects of treatment or a range of potential treatment durations, such as minimum and / or maximum treatment durations. In other cases, treatment duration includes the number of pulses applied to tissue from, for example, a balloon.

[0076] In embodiments, the treatment intensity comprises a measure of the intensity of the treatment applied to the tissue. For example, where the treatment comprises applying pulsed or static energy to the tissue, the treatment intensity comprises a measurement of such static or pulsed energy applied to the tissue (such as the amplitude or magnitude of the treatment energy) or another measurement of the intensity of energy applied to the tissue known in the art (such as, for example, a root mean square measurement of the intensity of the pulsed energy applied to the tissue). In other cases, the treatment intensity comprises a minimum and / or maximum energy applied to the tissue. For example, in embodiments where pulsed pressure is applied to the tissue, the treatment intensity may comprise a minimum and maximum amount of pressure applied to the tissue. In some instances, the treatment intensity comprises an overall treatment intensity and / or treatment intensities corresponding to various aspects of the treatment. In some cases, the treatment intensity comprises one or more specific intensity values ​​(e.g., minimum and / or maximum treatment intensities) corresponding to the intensity or range of potential treatment intensities for one or more aspects of the treatment.

[0077] In an embodiment, the treatment frequency includes the frequency and / or duty cycle at which the treatment is applied. In some embodiments, where the catheter-based procedure includes the application of pulsed energy, for example, applying the pulsed energy to tissue (such as cardiovascular tissue, such as a heart valve) or a stenotic artery or a chronic total occlusion, the treatment frequency includes the frequency at which the pulsed energy is applied to the tissue and / or the duty cycle for applying the pulsed 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 or a range of potential treatment frequencies and / or duty cycles for one or more aspects of the treatment, such as a minimum and / or maximum treatment frequency and / or duty cycle. In some cases, the treatment frequency can be related to a physiological aspect of the subject being treated, such as a frequency that is synchronized with the subject's cardiac cycle.

[0078] In an embodiment, configuring the catheter-based surgery includes automatically adjusting the configuration of the catheter-based system. In some cases, when a configuration for the catheter-based surgery (e.g., a treatment plan including configuration settings for the catheter-based surgery) is transmitted from the catheter-based information module, the catheter-based surgery can automatically reflect such configuration settings. For example, in the case where the catheter-based information module transmits a treatment plan including configuration settings for the catheter-based surgery (initial configuration or reconfiguration), the catheter-based surgery can be automatically configured to apply such configuration settings (at the start of treatment in the case of the initial configuration, or at the continuation of treatment in the case of reconfiguring the catheter-based surgery during treatment). In some embodiments, the catheter-based surgery includes submitting changes to the configuration of the catheter-based system to an operator for approval. That is, before the catheter-based surgery is configured accordingly, the operator of the catheter-based surgery may be required to approve the changed configuration or the initial configuration. For example, the catheter-based information module can generate a treatment plan including the proposed treatment settings; however, before such configuration settings are applied to the catheter-based surgery, the operator is required to approve such changes to the configuration settings. In some cases, the change to the configuration includes a range of potential configuration settings, and the operator approval includes selecting a particular configuration setting, such as a setting included in the range of potential configuration settings. Typically, an operator includes a person who controls, monitors, evaluates, or is otherwise present during a catheter-based procedure, such as a treatment provider in a treatment room or a treatment provider in a control room, e.g., remotely monitoring one or more treatments.

[0079] In embodiments, an operator of the catheter-based system (e.g., a physician) sets a configuration, such as the number of pulses applied by the balloon catheter. In such embodiments, the operator may configure such settings by inputting the settings directly into the catheter-based system, or may configure such settings based on a recommendation or suggestion received from a catheter-based surgery information module. Such a recommendation or suggestion may be generated by the catheter-based surgery information module based on imaging results or other input information, i.e., information received by the catheter-based surgery information module based on, for example, imaging results of relevant tissue or aspects of the catheter-based system.

[0080] In some embodiments, after obtaining access (i.e., initiating a procedure such that, for example, aspects of a catheter-based system (e.g., a distal region of a catheter) are enabled to access (i.e., be introduced into) a subject's tissue of interest, setting a catheter position (i.e., the catheter or cardiac tissue compliant element or distal crosser unit or other relevant aspects of a catheter-based system are located at a relevant location of the subject, such as proximate to, for example, a heart valve), priming (i.e., fluid present in the catheter-based system is primed), and otherwise preparing to apply treatment to the subject's tissue of interest, an operator (e.g., a physician) controls the catheter-based system (e.g., taps a treatment button once) to initiate treatment. Once initiated, the catheter-based system, in conjunction with a catheter-based procedure information module (i.e., based at least in part on treatment planning information provided by the catheter-based procedure information module), controls treatment delivery, including, for example, delivering an appropriate number of energy pulses at an appropriate (potentially variable) energy to the subject's tissue of interest. As treatment continues, the catheter-based system checks for compliance changes for any calcium ruptures in conjunction with the catheter-based procedure information module (i.e., based at least in part on information transmitted to the catheter-based procedure information module), checks for rupture conditions or other failure modes, and continues delivery of treatment until the aforementioned pulse cycle is delivered. In some cases, treatment plan information or one or more configuration settings are periodically or continuously updated from the catheter-based procedure information module to the catheter-based system based on information transmitted to and received from the catheter-based procedure information module.

[0081] Some embodiments are configured to support continuity of treatment. For example, for continuity of treatment, an operator or a catheter-based system in conjunction with a catheter-based surgical information module (in either case, utilizing, for example, imaging results) may be relied upon to confirm whether a previously treated lesion is being treated again, or 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 in conjunction with the catheter-based surgical information module may be configured to continue treatment where treatment was previously stopped during a previous treatment (i.e., a treatment plan may be generated by the catheter-based surgical information module that reflects configuration settings corresponding to where treatment was previously stopped during a previous treatment). In such embodiments, if a different lesion is instead being treated, the treatment plan (e.g., generated by the catheter-based surgical information module) may start from scratch, or may be reset to another configuration.

[0082] Catheter-based surgery :

[0083] Embodiments of the present invention may include any desired catheter-based surgery, as known in the art. In some cases, catheter-based surgery includes a method of applying pulsed energy to an internal luminal tissue location, including, for example, the application of a pulsed balloon catheter system. Further details on such catheter-based surgery that can be used in conjunction 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, catheter-based surgery includes a method of passing through a complete occlusion, including, for example, the application of a microcatheter system to pass through a complete occlusion. Further details on such catheter-based surgery that can be used in conjunction 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 cases, catheter-based surgery includes a method of applying pulsed energy to cardiovascular tissue, including, for example, the application of a system for applying pulsed energy to heart valve tissue. Further details regarding such catheter-based procedures that may be used in conjunction with the methods and systems described herein are described in U.S. Patent Application Serial No. 63,346,703, entitled “Systems and Methods for Treating Cardiovascular Tissue,” filed on the filing date of the present application (Attorney Docket No. AVSI-004PRV); the disclosure of which is incorporated herein by reference. Embodiments of the present invention may include catheter-based procedures for implanting a device. For example, embodiments may include catheter-based procedures for implanting a device, such as a stent (such as a self-expanding stent) or a replacement heart valve (such as an artificial heart valve or a donor heart valve). Such embodiments may be applied such that a treatment plan is associated with guidance intended to influence and / or predict a desired behavior of a device such as an implanted device. For example, in the case of a catheter-based procedure for deploying a stent, the treatment planning information may be related to predictions about how such a stent will respond when deployed, such as whether it will jump forward when a self-expanding stent is used, or how the stent and vessel tortuosity will respond when the stent is deployed, or whether the stent will cause edge peeling, or whether the stent will fully expand or whether the vessel requires more preparation. In the case of a catheter-based procedure for deploying a replacement heart valve, the treatment planning information may be related to predictions about how the replacement heart valve will position itself and function.

[0084] sensor :

[0085] In certain embodiments, a catheter-based system (e.g., including, for example, a cardiac tissue compliant element or angioplasty balloon or catheter) configured to perform various aspects of a catheter-based procedure according to embodiments of the present invention may include 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 the catheter-based procedure is performed. In embodiments of the present invention, such data may include information transmitted to and / or transmitted from a catheter-based procedure information module. In such embodiments, in each case, the sensor is configured to transmit information to and / or receive information from a controller or another aspect of the catheter-based system, such that such information may be transmitted to and / or transmitted from the catheter-based information module, or in other cases, the sensor may be configured to transmit information directly to and / or transmit information from the catheter-based procedure information module. In such instances, data collected from sensors may be fused to assess the behavior of a catheter-based system or tissue (e.g., cardiovascular tissue), for example, on which a catheter-based procedure is performed, which occurs at different frequencies or amplitudes of pressure applied to various aspects of the catheter-based system (such as, for example, an angioplasty balloon or cardiac tissue compliance element or angioplasty balloon or catheter). A controller or other aspects of a catheter-based system or catheter-based surgery information module may be configured to read data from sensors and adjust the treatment applied via the catheter-based procedure, such as the treatment provided to the cardiovascular tissue, in the form of a feedback and / or feedforward loop. A controller or other aspects of a catheter-based system or catheter-based surgery information module may also be configured to determine a more optimized treatment profile or treatment plan (i.e., a system configuration, such as a pressure, frequency, and / or duty cycle configuration, for implementation by a catheter-based system to address a disease condition, such as calcification present on the cardiovascular tissue or other disease conditions in the associated tissue). That is, the catheter-based surgery information module may generate a revised treatment plan based on information (i.e., sensor data) collected while performing the catheter-based procedure. A controller or other aspect of the catheter-based system or catheter-based procedure information module may also be configured to adjust the treatment profile so that treatment is performed according to a previously determined optimal treatment profile. When performing a catheter-based procedure, any convenient commercially available sensor (e.g., pressure, temperature, volume sensor, etc.) may be utilized, i.e., utilized in the catheter-based system and integrated into aspects of the system as needed for the sensor.In conjunction with practical aspects of the present invention, any convenient commercially available means of transmitting data collected by the sensors to a controller or directly to a catheter-based surgical information module may be utilized, such as a wired or wireless data connection, such as a network connection, a dedicated communication line or bus, etc.

[0086] Robotics:

[0087] Another aspect of embodiments of the present invention relates to robotic treatment of diseased tissue (e.g., cardiovascular tissue). In one configuration, a catheter-based system for performing a catheter-based procedure in conjunction with implementing embodiments of the present invention is located at a treatment location (i.e., a location where such a system is used to treat a subject), such as an operating room or a treatment room or a procedure room. Connected to the treatment location is a control room that includes system controls and / or system results, such as data collected by sensors of the catheter-based system, and embodiments of a catheter-based procedure information module, or access to a connection such as a catheter-based procedure information module of the present invention, such as a network connection. The control room can be operably connected to the 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 a catheter-based procedure using a catheter-based system, such as for imaging or device sensors. In addition, the control room can include a treatment controller that enables an operator to control various aspects of the treatment, such as treatment initiation and device positioning, i.e., the position of a catheter or angioplasty balloon or cardiac tissue compliance element, etc. relative to tissue (e.g., cardiovascular tissue of a subject present in the treatment room). Such a treatment controller can be operably connected to a catheter-based procedure information module such that the catheter-based information module can interface with the controller to, for example, directly or via operator approval, configure aspects of a catheter-based system for performing a catheter-based procedure, i.e., be configured to generate, store and / or transmit treatment plan information related to controlling various aspects of the catheter-based system when performing a catheter-based procedure associated with, for example, cardiovascular tissue of a subject. As described above, a treatment profile or treatment plan can include system configurations, such as pressure, frequency and / or duty cycle configurations, for implementation by the catheter-based system to address, for example, calcification present on cardiovascular tissue. Other aspects of the control room can include information about the subject, for example, displaying the patient's vital signs or other pre-treatment and / or treatment period and / or post-treatment information.

[0088] In some cases, the control room may be several feet away from the operating table (such as behind a lead curtain or other form of shielding) or may be located in a different geographic location (such as in another building or another city or country). One or more operators can interact in the control room and can communicate with the subject or other operators at the treatment location.

[0089] Visualization :

[0090] Performing the catheter-based surgery of the present invention may also include using a system including a marker band present in various aspects of the system, such as, for example, a catheter or angioplasty balloon or a cardiac tissue compliant element, etc. The marker band can be fixed to different parts of the system, such as, for example, different positions on a catheter, a cardiac tissue compliant element, or a guidewire passing through the catheter. When applied to a subject by, for example, any convenient fluoroscopic technique, the marker band can be used to visualize the position of the system or its components, such as a cardiac tissue compliant element. The results of the visualization technique (such as the position or configuration or orientation of the catheter-based system used to perform the catheter-based surgery of the present invention) may include data transmitted to and / or transmitted from the catheter-based information module. In an example, the catheter-based information module can be configured to evaluate the visualization information, for example, it can be configured to perform image processing to evaluate any relevant aspects of the catheter-based surgery, such as, for example, changes in tissue properties caused by performing the catheter-based surgery, or changes in the position of the catheter-based system relative to the subject when performing the catheter-based surgery.

[0091] The marker band used in conjunction with performing a catheter-based procedure can be any convenient, readily available, off-the-shelf marker band that can be secured to a component of a catheter-based system, for example, by forging, crimping or heat bonding or welding or bonding. The marker band of interest can be a polymer band loaded with gold or platinum or tungsten or another material that aids in visualization, such as visualization by fluoroscopy. The marker band can be visualized by fluoroscopic or radioscopic visualization techniques.

[0092] Embodiments of the present invention may be configured to take into account the anatomical location of a catheter-based procedure in order to fuse imaging data with treatment data (e.g., fuse imaging data with other data obtained before, during, or after treatment). Such embodiments may be used to overlay pre-treatment and post-treatment results and determine results. Such embodiments may include registration of pre-treatment and post-treatment imaging data.

[0093] 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 instances, such embodiments may also employ techniques based at least in part on such imaging to automatically measure calcium structures present in the tissue of interest (i.e., calcium eccentricity, calcium thickness, and / or calcium length), assign a score representing an aspect of such calcium present in the tissue of interest, and generate a treatment plan, wherein the treatment plan includes, for example, peak pressure, frequency, and / or intravascular lithotripsy energy based at least in part on such scores. Any available imaging-based scoring technique can be used, including, for example, 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 angiographic 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:PMC 4262070; each reference is incorporated herein by reference. In embodiments, such a scoring system can be applied to pre-treatment planning, and additional measurements can 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 can include counting the cracks produced in the calcium structure, and in some cases, can also include notifying the clinician whether enough energy has been applied to treat the injury.Such procedures may occur on a patient-by-patient basis, or may rely on a learning algorithm, such as a cloud-based learning algorithm (i.e., fusing pre-treatment, during-treatment, and / or post-treatment OCT or IVUS images with treatment data to estimate the amount of calcium cracking and lumen dilation that occurred). Based on such results, future treatments (i.e., subsequently generated treatment plans) utilize such data to output the appropriate amount of energy to ensure that sufficient cracking occurs to achieve optimal lumen gain in the safest manner.

[0094] Having generally described various aspects of the method of embodiments of the present invention above, various aspects of the method of the present invention are now further reviewed in the context of specific embodiments. Specific embodiments

[0095] Aspects of the claimed invention are described in conjunction with the embodiments of the methods illustrated in the figures described below for ease of illustration only and without limiting the invention to such embodiments.

[0096] exist Figure 1 An exemplary catheter-based system for performing a catheter-based procedure in conjunction with an embodiment of the present invention is schematically illustrated in FIG. Figure 1 In the embodiments set forth in, the system is configured to apply pulsed energy to cardiovascular tissue. In some instances, the system may include a console assembly having a potential energy source (such as a high voltage or pressure source), a regulator (e.g., for regulating the output of the pressure source, etc.), and a controller (e.g., for controlling various aspects of the system). The system may also include a manifold assembly operably connected to the output of the console assembly, the manifold assembly including an oscillator for converting the output of the potential source into pulsed energy. The system may also include a catheter assembly operably connected to the output of the manifold assembly for converting the output of the manifold assembly (i.e., a first pulsed energy) into, for example, hydraulic oscillations or other forms of oscillating potential energy (i.e., a second pulsed energy) and transmitting the second pulsed energy to a cardiac tissue compliance element via a catheter (i.e., a fluid channel of the catheter). The cardiac tissue compliance element may be configured to receive the oscillating potential energy and apply the pulsed energy to the cardiovascular tissue. In embodiments, the oscillating potential energy is used to drive various aspects of the cardiac tissue compliance element, such as, for example, one or more balloon angioplasty oscillations or the movement of radial members to bend or flex the cardiovascular tissue. The controller can control the frequency, duty cycle and / or amplitude of the output energy from the potential source of the console assembly and the oscillator of the manifold assembly, for example based on the configuration settings included in the treatment plan. The connector of the catheter assembly can convert the energy output by the manifold assembly into, for example, hydraulic oscillations, thereby generating oscillations in various aspects of the cardiac tissue compliant element.

[0097] Figure 1A schematic diagram of an exemplary embodiment of a system 100 for applying pulsed energy to cardiovascular tissue according to the present invention is depicted. Figure 1 The depicted exemplary system 100 for catheter-based surgery includes three components: a console assembly (i.e., console subsystem) 110, which may include one or more console units 120; a manifold assembly (i.e., manifold subsystem) 140, which may include one or more subunits, including an oscillator 141; and a catheter assembly (i.e., catheter and balloon subsystem) 150, which may include one or more connectors 151 and a catheter 154 having a fluid channel (not shown) and a cardiac tissue compliant element 165. Each connector 151 of the catheter assembly 150 is connected to the oscillator 141 and one or more connector-catheter transition hubs 153 of the manifold assembly 140 for transmitting pulse energy (i.e., second pulse energy) to the cardiac tissue compliant element 165 via the catheter 154.

[0098] The console assembly 110 may include one or more console units 120. When the console assembly includes multiple console units, such console units may be combined into a single physical component (i.e., a housing) or divided into multiple housings, such as one housing for each console unit. In each case, the console units are configured to operate independently of each other, i.e., to be independently controlled, whether the console units are present in a single housing or in multiple housings. The console unit 120 includes a potential source 121, a potential regulator (not shown), and a controller 130 for generating energy transmitted to the manifold assembly 140. The output from the potential source 121 may include regulated potential energy 122 or unregulated potential energy, such as potential energy from a high-pressure fluid or voltage. The potential regulator may be used to change 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., so that the oscillator 141 can generate pulse energy according to the energy transmitted from the potential source 121. A plurality of console units 120 (i.e., console units numbered 1 to n) may be included in the console assembly 110 and may be operated substantially in parallel (i.e., independently) to generate a plurality of potential outputs 122 for transmission to a plurality of oscillators 141. In some instances, the plurality of console units 120 may be configured to generate a plurality of potential outputs 122 in the case where treatment of cardiovascular tissue includes applying pulsed energy of different configurations to the cardiovascular tissue, for example, in the case where the cardiac tissue compliant element includes a plurality of balloons configured to expand independently at potentially different frequencies, duty cycles, and / or amplitudes. In such instances, the different potential outputs 122 may be applied to the cardiovascular tissue separately, for example, via different balloons or other aspects of the cardiac tissue compliant element or at different times (i.e., where one of the potential outputs 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 instances, the potential outputs 122 from the plurality of console units 120 may be combined. In still other examples, where treatment of cardiovascular tissue requires application of different forms of energy, multiple console units 120 may be configured to generate multiple potential outputs 122 that include different forms of potential energy (eg, high voltage or voltage).

[0099] The console assembly 110 also includes a controller 130 configured to receive input from at least one of the console assembly 110, the manifold assembly 140, and the catheter assembly 150. The controller 130 is also configured to be operably connected to a catheter-based surgery information module 199 so that data regarding a catheter-based surgery performed by the system 100 can be transmitted to and / or from the catheter-based surgery information module 199. Figure 1, controller 130 is shown receiving input from catheter assembly 150 (i.e., sensor 152 of catheter assembly 150). Sensor 152 may include any sensor configured to sense any relevant characteristic of catheter assembly 150 that can be detected. For example, sensor 152 may include a pressure transducer configured to measure the pressure within catheter assembly 150, such as, for example, the pressure of a fluid channel of catheter 154 or the pressure of one aspect of cardiac tissue compliance element 165, such as an angioplasty balloon; alternatively, sensor 152 may include a volume sensor configured to measure, for example, the volume of fluid present in the balloon. In an example, the controller 130 can be configured to receive input from a plurality of sensors, including sensors configured to measure any relevant aspect of the system 100 or the environment in which the system 100 is applied (e.g., pressure sensors, temperature sensors, volume sensors, etc.), 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 cardiac tissue compliance element 165, the catheter 154, the connector-catheter transition hub 153, the connector 151, the oscillator 141, 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, information related to a therapeutic procedure. In other examples, the controller 130 can be configured to receive input from a user input, such as a button or switch for specifying a treatment option (e.g., system pressure, frequency, duty cycle, etc.) or to modify or update a treatment option or configuration, for example, to confirm or modify aspects of a treatment plan generated by and transmitted from the catheter-based procedure information module 199. In Figure 1 , the controller 130 receives input from the pressure transducer 152 of the catheter assembly 150 and generates control signals for controlling various aspects of the console assembly 110 based at least in part on such input, such as, for example, the magnitude of the potential output 122, i.e., via an active regulator (not shown) for regulating the magnitude of the potential output 122 (e.g., the output pressure).

[0100] exist Figure 1In the embodiment schematically shown in FIG. 1 , the output of the console assembly 110 is operably connected to the manifold assembly 140, so that 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 pulsed 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 allow or interrupt the transmission of energy to the catheter assembly 150. In other examples, the oscillator 141 may include any applicable electrical switch as known in the art, such as an electromagnetic coil, an optical or mechanical switch.

[0101] exist Figure 1 , the controller 130 is shown connected to the manifold assembly 140. In an example, the oscillator 141 can be configured so that the oscillation frequency and / or duty cycle can be controlled by the controller 130, for example, so that the controller 130 controls the position of the solenoid of the oscillator 141 or other aspects of the behavior.

[0102] exist Figure 1 In the embodiment schematically shown in FIG. 1 , the output of the oscillator 141 of the manifold assembly 140 is operably connected to the conduit assembly 150. Specifically, the output of the oscillator 141 is connected to the input of the connector 151. The connector 151 is configured to convert the potential energy generated by the oscillator 141, such as, for example, pneumatic pressure (i.e., the first pulse energy), into a second potential energy, such as, for example, hydraulic pressure (i.e., the second pulse energy). Figure 1 The illustrated system 100 includes a plurality of connectors 151 (connectors 1 to n), one connector 151 corresponding to one oscillator 141. The output of the connector 151 is operably connected to a connector-catheter transition hub 153, which is configured to enable the potential energy output of the connector 151 (i.e., the second pulse energy) to be input into the catheter 154, for example, one or more fluid channels (not shown) of the catheter 154. In some cases, the catheter assembly 150 includes more than one catheter 154, or the catheter 154 includes more than one fluid channel located inside or outside the catheter 154, that is, so that different aspects of the cardiac tissue compliant element 159 can be independently operated (e.g., so that different angioplasty balloons or radial members including the cardiac tissue compliant element 159 can be independently pressurized or expanded and deflated).

[0103] In the catheter assembly 150 of the system 100, the catheter 154 includes a channel dedicated to the guidewire so that the catheter 154 and the cardiac tissue compliant element 159 can be guided to the cardiovascular tissue treatment site by a standard over-the-wire guidewire method. The connector-catheter transition hub 153 is configured to include a guidewire outlet 161 at the proximal region of the guidewire for spiraling through the guidewire channel of the catheter 154. The guidewire outlet 161 is opposite to the guidewire inlet 157, which is located at the relatively distal region of the cardiac tissue compliant element 165. For illustrative purposes only, in order to highlight the position of the guidewire outlet 161 relative to other components of the system 100, the guidewire outlet 161 is depicted as being oriented away from the longitudinal axis of the catheter 154. In an embodiment, the guidewire outlet 161 is oriented in a manner parallel to the longitudinal axis of the catheter 154 (and therefore parallel to the longitudinal axis of the guidewire channel in the catheter 154) to avoid any unnecessary bending of the guidewire present in the system 100. As described above, the system 100 can be configured relative to a guidewire such that the system 100 is an over-the-wire, rapid exchange, monorail, or similar system.

[0104] exist Figure 1 In the system schematically shown in , a cardiac tissue compliant element 165 is present at a distal region of a catheter 154. In system 100, the cardiac tissue compliant element 165 is configured to adapt to cardiovascular tissue including an aortic heart valve, such that the cardiac tissue compliant element 165 spans the leaflets of the aortic valve, wherein the distal region of the cardiac tissue compliant element 165 is present on the ventricular side of the aortic valve and the proximal region is present on the aortic side of the aortic valve. The cardiac tissue compliant element 165 includes a plurality of angioplasty balloons and other features (e.g., positioning elements or nubs, etc.) configured to engage various aspects of the aortic heart valve. The angioplasty balloons of the cardiac tissue compliant element 165 include one or more outer commissure balloons (e.g., wing-shaped balloons) 158 and one or more inner valvuloplasty balloons (e.g., mid-radius balloons) 159. The angioplasty balloons 158, 159 of the cardiac tissue compliant element 165 may be independently operable (ie, capable of being pressurized and depressurized independent of whether the other balloon is pressurized or depressurized).

[0105] The outer commissure balloon 158 is present at a relatively outer radial distance sufficiently far from the longitudinal axis of the cardiac tissue compliant element 165 so that the outer commissure balloon 158 can engage with the aortic valve commissures (i.e., apply pulse energy thereto), for example, to disrupt calcium formation in the aortic valve commissures that inhibits normal valve function. The outer commissure balloon 158 can include non-compliant / compliant materials. The cardiac tissue compliant element 165 can include a plurality of outer commissure balloons 158 configured such that the outer commissure balloon 158 engages each valve commissure of the aortic valve, for example, including three outer commissure balloons 158 to engage each aortic valve commissure.

[0106] The outer commissure balloons (e.g., wing-shaped balloons) 158 can be configured to be independently operable, i.e., independently pressurized and depressurized from a second outer commissure balloon and from the inner valvuloplasty balloon 159, e.g., by being pressurized by hydraulic pressure transmitted via separate fluid chambers of the catheter 134. Alternatively, the outer commissure balloons 158 can be configured so that they are pressurized and depressurized simultaneously, e.g., by being pressurized by hydraulic pressure transmitted via a single fluid channel of the catheter 134 that supplies multiple outer commissure balloons 158.

[0107] The endovalvuloplasty balloon (e.g., a mid-radius balloon) 159 is present at a sufficient relative inner radial distance from the longitudinal axis of the cardiac tissue compliant element 165 so that the endovalvuloplasty balloon 159 can engage with (i.e., apply pulsed energy to) the aortic valve leaflets, for example, to disrupt calcium formation in the aortic valve leaflets that inhibits normal valve function. The cardiac tissue compliant element 165 can include a plurality of endovalvuloplasty balloons 159 configured such that the endovalvuloplasty balloon 159 engages each leaflet of the aortic valve. For example, the cardiac tissue compliant element 165 can include three endovalvuloplasty balloons 159 to engage each aortic valve leaflet, or include a single endovalvuloplasty balloon 159 configured such that a different surface of the single balloon engages each aortic valve leaflet.

[0108] The inner valvuloplasty balloon 159 can be configured to be independently operable, i.e., independently pressurized and depressurized from the second inner valvuloplasty balloon and from the outer commissure balloon 158, e.g., by being pressurized by hydraulic pressure transmitted via separate fluid channels of the catheter 134. Alternatively, the inner valvuloplasty balloons 158 can be configured so that they are pressurized and depressurized together simultaneously, e.g., by being pressurized by hydraulic pressure transmitted via a single fluid channel of the catheter 134 configured to supply multiple balloons.

[0109] exist Figure 1In the system 100 schematically shown in FIG. 1 , the catheter 154 and the cardiac tissue compliant element 165 are configured to allow fluid (e.g., blood) to perfuse through the cardiac tissue compliant element 165 even when pulsed energy is applied to the cardiovascular tissue at the treatment site. For example, in the system 100, the catheter 154 and the cardiac tissue compliant element 165 are configured to enable blood to be transferred (i.e., perfused) from the perfusion inlet region 156 to the perfusion outlet region 155 via one or more channels (not shown), for example, the perfusion inlet region 156 is fluidly connected to the perfusion outlet region 155, allowing blood received from the distal region (i.e., the ventricular region) to exit at the proximal region (i.e., the aortic region) of the cardiac tissue compliant element 165. The perfusion inlet region 156 and the perfusion outlet region 155 include perforations or ports (not shown) in the catheter 154 or the cardiac tissue compliant element 165 through which blood can flow. This configuration enables blood to flow through the cardiac tissue compliant element 165, thereby extending the treatment time. Such a perfusion mechanism may also include a structure (e.g., a valve or an oscillating balloon mechanism) in the catheter 154 or the cardiac tissue compliant element 165 that allows fluid to flow in only one direction. The catheter 154 includes a proximal catheter portion 163 and a distal catheter perfusion portion 162. The distal catheter perfusion portion 162 includes a perfusion inlet region 156, a perfusion outlet region 155, and one or more channels (not shown), such as fluidly connecting the perfusion inlet region 156 with the perfusion outlet region 155. The proximal catheter portion 163 and the distal catheter perfusion portion 162 may be connected by a connector (not shown).

[0110] Any convenient perfusion mechanism may be employed in the catheter 154 and the cardiac tissue compliant element 165 to direct the flow of fluid (e.g., blood) through the perfusion region, i.e., from the perfusion inlet region 156 to the perfusion outlet region 155, past the cardiac tissue compliant element 165, i.e., moving from the distal region to the proximal region of the cardiac tissue compliant element 165, such that the cardiac tissue compliant element 165 does not completely obstruct the flow of fluid (e.g., blood) when present, for example, in a blood vessel. As described above, a passive perfusion mechanism may be used to direct the flow of fluid from the perfusion inlet region 156 to the perfusion outlet region 155 based on an existing pressure gradient (i.e., an existing pressure difference caused, for example, by ventricular contraction), or an active perfusion mechanism, including, for example, a syringe, such as a barrel-shaped syringe, configured to move fluid from the perfusion inlet region 156 to the perfusion outlet region 155 through the perfusion region and past the cardiac tissue compliant element 165.

[0111] Various aspects of system 100, such as, for example, console assembly 110 (e.g., controller 130), manifold assembly 140 (e.g., oscillator 141), and various aspects of catheter assembly 150 (e.g., connector 151 and connector-catheter transition hub 153) can be configured to be reusable. In an example, various aspects of system 100, such as, for example, catheter 154 or cardiac tissue compliant element 159 can be configured to be used once (e.g., such that it is disposable). The terms "reusable" and "disposable" are used here and elsewhere in the specification for convenience in describing, for example, catheter-based systems such as Figure 1 The exemplary system 100 shown. However, the system for catheter-based surgery is not limited thereto. As such, any portion of the system used in conjunction with the catheter-based surgery of the present invention may be configured for single use or multiple use, as desired.

[0112] Figure 2 A flowchart 200 is shown for performing a method according to some aspects of the present disclosure, the method involving performing a catheter-based procedure on a subject and transmitting data about the catheter-based procedure to and / or from a catheter-based procedure information module. An exemplary catheter-based procedure performed in conjunction with flowchart 200 may include using a catheter-based system, such as, for example Figure 1 The catheter-based system 100 described in the claims is used, for example, to apply pulsed energy to cardiovascular tissue.

[0113] The process begins at box 205 of flowchart 200, where treatment is started, i.e., a method according to some aspects of the present disclosure is initiated. The process continues from box 205 to box 210. At box 210, before a catheter-based surgery is performed on a subject, pre-treatment data about the subject is collected. The pre-treatment data collected at box 210 may include, for example, imaging data, vital sign data, or other measurements of any relevant aspects of the catheter-based surgery, such as measurements of the subject or a catheter-based system used to perform the surgery. As described above, the imaging data may include, for example, one or more of angiographic imaging, computed tomography, optical coherence tomography, intravascular ultrasound imaging, echocardiography, or any other desired imaging technology that may be used in conjunction with a catheter-based surgery, as known in the art. In some cases, the imaging data is used to visualize aspects of the diseased tissue that the catheter-based surgery is intended to address. In other cases, the imaging data is used to visualize aspects of the subject, such as aspects of the anatomical structure of the subject or a catheter system. As described above, the vital sign information may include, for example, body temperature, pulse rate, respiratory rate, or any other physiological measurement of the subject relevant to the catheter-based procedure, as is known in the art. As described above, other measurements (i.e., pre-treatment measurements) may include, for example, measurements of ventricular pressure, aortic pressure, coronary pressure, results of an electrocardiogram, or any other relevant measurement related to the subject or the catheter-based procedure, such as measurements of an aspect of a catheter-based system used to perform the catheter-based procedure. The pre-treatment information (such as the above-described information) collected at block 210 may be used by a catheter-based system (e.g., such as a catheter-based system) used in conjunction with performing the catheter-based procedure. Figure 1 The system 100 of FIG. 200 may be used to collect the relevant pre-treatment data, or may be collected using other devices or systems capable of collecting relevant pre-treatment data and transmitting the collected pre-treatment data to either or both of such catheter-based systems for performing catheter-based procedures or directly to the catheter-based information module 299. The process continues from block 210 to block 215.

[0114] At box 215, the pre-treatment data collected at box 210 is transmitted 290a to a catheter-based surgery information module 299. The pre-treatment data is transmitted 290a to the catheter-based surgery information module 299 so that the pre-treatment data can be read, stored, and analyzed by the catheter-based surgery information module 299. The catheter-based information module 299 is depicted as being located at a remote location, for example, a cloud-based configuration, such as on a cloud cluster that is available and accessible via a network connection, for example, via any convenient Internet connection, such as a wired or wireless connection; however, in other cases, the catheter-based surgery information module 299 can be integrated into a catheter-based system for performing a catheter-based surgery. In this embodiment, analyzing the pre-treatment data by the catheter-based surgery information module 299 includes applying a treatment planning algorithm that is configured to generate a treatment plan (i.e., a potential configuration for performing one aspect of the catheter-based surgery as described above) based at least in part on the pre-treatment data transmitted to the catheter-based surgery information module 299, in this case, generating an initial treatment plan. As described above, the treatment planning algorithm applied by the catheter-based information module 299 may include a lookup algorithm, for example, an algorithm in which pre-treatment data is used to access a data store (e.g., a database) of previously performed catheter-based procedures, in some cases with comparable 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 that are trained to generate a treatment plan based at least in part on the pre-treatment data collected in box 210. At box 215, the treatment planning algorithm is also configured to store the pre-treatment data received in box 210 to a data storage device, such as a cloud-based data storage device, for subsequent access (i.e., lookup) by the treatment planning algorithm or for training or refining or further training the machine learning algorithm of the treatment planning algorithm. At box 215, a treatment plan (i.e., a treatment profile) is generated based at least in part on the pre-treatment data collected in box 210. The resulting treatment plan includes one or more initial configuration settings for the catheter-based system for performing the catheter-based procedure.

[0115] Any convenient technique may be applied in conjunction with the catheter-based information module 299 receiving 290a and processing the pre-treatment data collected at block 210 (as well as receiving 290c and processing the pre-treatment data collected at blocks 240 and 245, and receiving 290d and processing the post-treatment data collected at blocks 265 and 270). That is, any convenient technique may be applied so that the data received by the catheter-based information module 299 is meaningful, for example, for generating a treatment plan and / or updating a database of catheter-based surgical information (such as configuration settings). In some cases, such techniques include a physician marking relevant data, performing a database comparison and / or lookup in conjunction with the data received by the catheter-based information module 299. In some cases, the treatment data may be presented to a clinician or other trained personnel, such as a medically trained personnel, for marking or classifying or identifying relevant features or aspects of the collected data. In some cases, such data identification processes may be gamified so that rewards, such as some form of payment or points, are received in exchange for processing the data (e.g., marking or classifying or identifying relevant features of the data collected in conjunction with the catheter-based treatment). Other techniques for leveraging the collective expertise of trained personnel to establish well-labeled / classified / identified data populations may be applied, such as, for example, peer review programs for group-based surgical skill assessment, such as 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. Mar 2022, 79(9_Suppl)615, which is incorporated herein by reference.

[0116] From block 215 , the process continues to block 220 .

[0117] At box 220, the result of analyzing the pre-treatment data by the catheter-based information module 299, i.e., applying the treatment plan algorithm, is displayed. For example, such a result can be displayed on a monitor or screen that is configured to be viewed by an operator or treatment provider. Specifically, at box 220, information about the treatment plan, i.e., the optimal treatment profile, is transmitted 290b from the catheter-based surgery information module 299 and displayed for the operator to view. Such a treatment plan transmitted 290b from the catheter-based surgery information module 299 is displayed on a display operably connected to the catheter-based system for the operator to approve, i.e., for performing a catheter-based surgery. Such an operator can be a treatment provider, or a person who assists in performing a catheter-based surgery at a treatment location or a control location (e.g., a control room) away from the catheter-based surgery location. Elements of the treatment plan transmitted 290b from the catheter-based procedure information module 299 at box 220 may include device type, including balloon type (i.e., size, shape, compliance properties, material, other features such as positioning blocks, etc.), treatment type (i.e., pulsed energy, static energy, applied pressure or other form of energy), treatment duration (i.e., the amount of time the catheter-based procedure or an aspect thereof is applied), treatment intensity (i.e., the minimum and / or maximum energy amplitude applied via the catheter-based procedure), treatment frequency (i.e., the frequency of pulsed energy applied via the catheter-based procedure or the duty cycle of the catheter-based procedure), or any other configuration settings related to the catheter-based procedure, as known to those skilled in the art. The process continues from box 220 to box 225.

[0118] At box 225, the treatment plan (i.e., the initial treatment plan) or aspects thereof generated by the catheter-based surgery information module 299 is presented to an operator or treatment provider responsible for controlling aspects of the catheter-based surgery, such as a clinician at or near the treatment location (e.g., a control room or treatment room) for approval. The catheter-based system for performing catheter-based surgery can include any convenient display or monitor for presenting the treatment plan to the operator. The catheter-based system for performing catheter-based surgery can also include one or more input devices for the operator to confirm agreement with the proposed treatment plan, such as by clicking a confirmation button using a mouse or a touch pad device such as a touch screen.

[0119] If the operator confirms agreement with the treatment plan, the process moves from box 225 to box 235. Optionally, in the event that the operator indicates a desire to change an aspect of the treatment plan, the process moves to box 230, where the operator can enter an alternative treatment plan, for example, including one or more alternative configurations or settings of the treatment plan, referred to as a clinician-determined treatment (e.g., the operator can indicate that a different balloon type will be used in performing the catheter-based procedure). That is, in the event that the operator enters an alternative configuration, the process moves from box 225 to box 230. At box 230, the operator can reconfigure any relevant aspects of the treatment plan; that is, the catheter-based system can be configured to enable the operator to override any configuration settings for the catheter-based procedure so that the treatment plan effectively includes the initially suggested configuration. When an alternative configuration setting is entered at box 230, the process moves to box 235.

[0120] At box 235, the initial treatment plan (i.e., the initial configuration for the catheter-based procedure) has been finalized (i.e., the initial treatment plan is ready to be applied to the catheter-based procedure) by the operator's confirmation or modification at boxes 225 and 230 and includes the treatment plan generated by the catheter-based procedure information module 299 or the treatment plan modified or otherwise updated by the operator, i.e., the clinician, at box 230. The catheter-based procedure is initiated at box 235 using the configuration (e.g., device type, balloon type, etc.) included in the treatment plan. By initiating the catheter-based procedure at box 235, it is meant that the catheter-based device, i.e., the catheter and balloon or other treatment device fixed to the distal end of the catheter, is selected and prepared for treatment, i.e., applied to the subject, as known to those skilled in the art. Initiating the catheter-based procedure also includes accessing the treatment site, for example, by inserting the catheter and catheter device into the subject. For example, where the catheter device includes a cardiac tissue compliant element, a cardiac tissue compliant element of appropriate size and configuration is selected, such as a cardiac tissue compliant element having a winged balloon for addressing calcification in the heart valve commissures, and the cardiac tissue compliant element is positioned adjacent to the diseased heart valve of the subject. After initiating the procedure at block 235, the process moves to block 240.

[0121] At block 240, the catheter-based procedure continues such that therapy is deployed by, for example, configuring the catheter-based procedure to deliver energy (such as pulsed energy) to tissue (i.e., cardiovascular tissue of the subject). That is, at block 240, the catheter-based procedure delivers therapy (e.g., for destroying calcifications within the subject's tissue), for example, in the form of energy delivered to the tissue. For example, at block 240, where the catheter-based procedure includes applying pulsed energy to the tissue, such pulsed energy is applied and delivered to the tissue.

[0122] Additionally, at block 240, treatment period data (i.e., procedure period data) regarding the catheter-based procedure is collected. For example, sensors, including sensors internal and external to the catheter-based system used to perform the catheter-based procedure, are configured to collect data regarding the treatment and / or the subject. As described above, the treatment period data may include information derived from device sensors (e.g., pressure or volume measurements), imaging data (e.g., ultrasound images indicating the position of the catheter device relative to the tissue or tissue images), subject vital signs (e.g., pulse, respiratory rate, blood pressure, etc.), or other measurements related to the catheter-based procedure. Depending on the type of treatment applied, the treatment period data may include estimates of changes in tissue compliance for evaluating the effectiveness of the catheter-based procedure, or other measurements that may be used to evaluate the effectiveness of the catheter-based procedure. After collecting the treatment period data, the process moves to block 245.

[0123] At box 245, the treatment session data is transmitted 290c to the catheter-based surgery information module 299 so that such treatment session data can be read, stored and / or analyzed by the catheter-based surgery information module 299, presented locally at or near the treatment location, including in some cases integrated into a catheter-based system for applying the catheter-based surgery, or presented remotely, for example, including a distributed system available through a network connection, such as a cloud-based configuration. The analysis of the treatment session data performed by the catheter-based surgery information module 299 can include calculating or looking up reference or historical data for evaluating the effectiveness of the catheter-based surgery. In some cases, the analysis of the treatment session data performed by the catheter-based surgery information module 299 includes comparing the instantaneous treatment session data with historical treatment session data, or applying a machine learning algorithm to evaluate the treatment session data, such as evaluating the effectiveness of the catheter-based surgery based on aspects of the treatment session data. When the catheter-based surgery information module 299 analyzes the treatment session data, the results of such analysis of the treatment session data by the catheter-based surgery information module 299 are transmitted 290c to the catheter-based system, and the process moves to box 250.

[0124] At box 250, at least a subset of the results of the analysis of the treatment session data by the catheter-based surgery information module 299 is presented to the operator of the catheter-based surgery or the treatment provider for confirmation as to whether the results of applying the catheter-based surgery are satisfactory, and therefore complete, or unsatisfactory, and therefore the catheter-based surgery should continue to apply further treatment. Such results can be presented to the operator using, for example, any convenient display or monitor, and the operator can use any convenient input device, such as, for example, a mouse or touch pad or touch screen, to indicate whether the treatment is satisfactory.

[0125] In the event that the operator indicates that the treatment results are satisfactory, the process moves to block 255 where the treatment is complete, i.e., the catheter-based procedure stops applying energy to the tissue (e.g., cardiovascular tissue of the subject), and the process moves to block 265. In the event that the operator indicates that the treatment is not satisfactory (i.e., the catheter-based procedure should continue to apply treatment to the diseased tissue), the process moves to block 260.

[0126] At box 260, treatment (i.e., application of the catheter-based surgery) continues, i.e., the catheter-based surgery continues to deliver energy to the tissue under the same or a modified treatment plan generated by the catheter-based surgery information module 299, with or without operator modifications to configuration settings related to the catheter-based surgery, i.e., the treatment plan is a treatment plan modified by the catheter-based surgery information module 299 and / or by an operator of the catheter-based surgery.

[0127] In some cases, at box 260, additional treatment session data is collected and transmitted to the catheter-based surgery information module, similar to the steps shown in boxes 240 and box 245. In addition, at box 260, in some cases, a revised treatment plan is transmitted from the catheter-based surgery information module 299 to revise the configuration of the catheter-based surgery; that is, the treatment mode (e.g., treatment type, device type, balloon type, treatment duration, treatment intensity, treatment frequency, etc.) can be modified in conjunction with continuing the catheter-based surgery. In addition, at box 260, subsequent treatment session data can be collected and analyzed so that the operator can indicate whether the treatment is satisfactory based on such results. Based on the indication that the treatment is satisfactory, or based on the occurrence of another end of treatment signal, such as completion of the treatment duration, the process moves to box 265.

[0128] At box 265, post-treatment data (i.e., post-procedure data) about the catheter-based procedure is collected. For example, sensors (including internal and / or external sensors) of the catheter-based device are configured to collect data about the catheter-based treatment. As described above, the post-treatment data may include information from device sensors (e.g., pressure or volume measurements), imaging data (e.g., ultrasound images indicating the orientation of the catheter device relative to the tissue or tissue images), subject vital signs (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 about the catheter-based procedure. That is, in each case, upon completion of the catheter-based procedure, the post-treatment data may include outcome information including, for example, data about acute valve opening, tissue compliance (such as valve compliance), intravascular pressure, or external pressure. Depending on the type of treatment applied, the post-treatment data may include an estimate of changes in tissue compliance for evaluating the effectiveness of the catheter-based procedure, or any other measurement related to the catheter-based procedure for evaluating the effectiveness of the catheter-based procedure. After collecting post-treatment data, the process moves to box 270.

[0129] At box 270, the post-treatment data is transmitted 290d to a catheter-based surgery information module 299 so that such post-treatment data can be read, stored and / or analyzed by the catheter-based surgery information module 299, which can be presented locally at or near the treatment location, including in some cases being integrated into a catheter-based system for applying catheter-based surgery, or remotely, for example including a distributed system available via a network connection, such as a cloud-based configuration.

[0130] The analysis of the post-treatment data performed by the catheter-based surgery information module 299 may include calculating or looking up reference or historical data for evaluating the effectiveness of the catheter-based surgery (i.e., generating result information such as a conclusion about the effectiveness of the treatment based on the final data collected from the catheter-based surgery). In some cases, the analysis of the post-treatment data performed by the catheter-based surgery information module 299 includes comparing the immediate post-treatment data with historical post-treatment data, or applying a machine learning algorithm to evaluate the post-treatment data, such as evaluating the effectiveness of the catheter-based surgery based on aspects of the post-treatment data. When the catheter-based surgery information module 299 analyzes the post-treatment data, the results of such analysis of the post-treatment data by the catheter-based surgery information module 299 are transmitted 290d to the catheter-based system, for example, for display and further analysis by an operator or treatment provider. The process set forth in the exemplary flowchart 200 ends at box 270.

[0131] Figure 3A schematic diagram of a control circuit for controlling a catheter-based system when performing a catheter-based procedure, such as a catheter-based procedure for treating diseased cardiovascular tissue (such as a diseased valve), is depicted. For illustrative purposes, a catheter-based system such as Figure 1 The system 100 is depicted. In this embodiment, the controller includes a subsystem that receives a treatment plan (i.e., a set of configurations for a catheter-based procedure, including configurations of a catheter-based system) fed into the controller. The treatment plan can be an initial treatment plan (i.e., a set of configuration settings for the catheter-based procedure that is specified prior to initiating the catheter-based procedure) or a revised treatment plan (i.e., a set of configuration settings for the catheter-based procedure that is specified at some time after initiating the catheter-based procedure, e.g., a revised treatment plan that is updated based on treatment session data collected while performing the catheter-based procedure), in each case generated by a catheter-based procedure information module, such as in Figure 2 The catheter-based surgical information module 299 depicted in the illustrated embodiment, or the depicted Figure 1 The catheter-based system 100 communicates with the catheter-based surgical information module 199 .

[0132] exist Figure 3 In the illustrated controller embodiment, based at least in part on the treatment plan input to the controller from the catheter-based surgery information module, the controller subsystem sends a signal, such as a voltage or data, to the potential source (regulated or unregulated) to control the amount of potential output by the potential source to the oscillator. The controller subsystem also sends signals to the oscillator, such as the frequency (f), i.e., the oscillation frequency, and the duty cycle (t 打开 and t 关闭 ) to control the circulating energy delivered by the oscillator. Feedforward models of individual subsystems (e.g., console assembly, manifold assembly, conduit assembly) or the system as a whole can be injected into the controller signal (i.e., the controller signal can be enhanced with such data about the feedforward model) to improve the controller's (i.e., control algorithm's) convergence on the correct supplied energy.

[0133] Treatment energy (i.e., potential energy) is delivered to the oscillator, but sensors can be used to track the magnitude of the potential energy delivered to the oscillator. Sensor signals can be fed back into the controller (and ultimately into a catheter-based surgical information module (not shown) used to generate one or more treatment plans) so that they can be used to converge the output of the system (i.e., the pulsed 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 delivered to the distal location (i.e., to the cardiac tissue compliance element and ultimately to the cardiovascular tissue) in an appropriate manner, which accounts for any attenuation, heat transfer, bubble formation, tissue relaxation, etc. The sensors measure system properties and characteristics of the tissue (e.g., cardiovascular tissue), such as pressure, volume, temperature, flow, etc. The sensor data from the catheter assembly is fed back into the controller so that such measurements can be used to converge the output of the system (i.e., the pulsed energy applied to the cardiovascular tissue) to the desired output, for example, as specified in the treatment plan input to the controller.

[0134] The catheter assembly sensor may be located at any convenient position of the catheter assembly, where they can be configured to produce appropriate measurements that can be used for the control system. For example, the sensor may be a pressure or volume sensor located on a connector. In other instances, such a sensor may be a sensor located in a catheter or a cardiac tissue compliant element (e.g., a balloon of a cardiac tissue compliant element) or an angioplasty balloon, etc., and connected to a guide wire configured to pass through the catheter. In other instances, such a sensor may include an X-ray image of a catheter or a cardiac tissue compliant element or an angioplasty balloon, etc., or the result of another fluoroscopic imaging technique, which is used to determine the position or expansion of one or more balloons of a catheter, a cardiac tissue compliant element, or an angioplasty balloon, etc.

[0135] The catheter assembly may include one or more sensors configured to measure information at one location as a means for determining conditions at other locations. For example, pressure and flow transducers may be configured to measure pressure and flow at a connector, but, for example, in conjunction with a fluid model of the system and pre-treatment data or treatment period data including, for example, X-ray or CT imaging, the sensor data may be used to measure pressure and / or volume of, for example, an angioplasty balloon or a balloon of a cardiac tissue compliance element. In addition, the sensor data may be provided to a clinician feedback transfer function, wherein such sensor feedback may be combined with feedback generated from a potential transfer facility or imaging data for processing into a feedback mechanism facility to provide feedback to a provider (i.e., an operator of the system) regarding the behavior of the system.

[0136] In other examples, pressure and flow rate sensors may be used to measure the compliance or change in compliance of an angioplasty balloon or a balloon of a cardiac tissue compliance element, etc. Assuming that the diseased tissue offers resistance to balloon expansion, the amount of volume forced into the balloon at a certain pressure is an indirect indication of the compliance of the tissue surrounding the balloon. In this way, a measure of compliance or a change in compliance may be used as a treatment metric or target, and this may be specified in a treatment plan input to a controller.

[0137] Figure 4 A schematic diagram of a system configuration 400 for an embodiment of the method of the present invention is depicted. The system configuration 400 may be configured to use a catheter-based system such as Figure 1 The depicted system 100 can be used to provide catheter-based procedures and, in addition, can be used in conjunction with robotics operated from a control room for delivering therapeutic energy to diseased tissue, such as a diseased valve. In configuration 400, the catheter-based system is divided into physically separate control room 410 and treatment location 420, which can be separated, for example, in different partitions of one room or in the next room or in a different city or state or country.

[0138] The control room 410 may include a console display, an imaging display, a treatment controller, a device position controller, patient information, and a connection to a surgical database 499, which is a catheter-based surgical information module, present on a computer system in the control room 410, or remotely accessed through a computer network connected to the computer system. The console display may be used to provide important information about the status of the catheter-based surgery and the catheter-based system associated with the ongoing treatment, such as, for example, pressure or volume measurements or other information about, for example, the cardiac tissue compliant element, such as the type of cardiac tissue compliant element employed. The information provided on the console display may be updated periodically during the treatment, such as substantially in real time. The imaging display may be used to provide imaging information, such as fluoroscopic imaging results, such as showing the position of the cardiac tissue compliant element relative to the cardiovascular tissue (e.g., heart valve). The fluoroscopic imaging results may also provide information about the status of various aspects of the cardiac tissue compliant element, such as, for example, whether the balloon is inflated and to what extent. The treatment controller may be used to adjust aspects of how the catheter-based system is applied to provide treatment, such as, for example, applying pulsed energy to the cardiovascular tissue, such as, for example, adjusting the pressure or frequency or duty cycle settings. In embodiments, the treatment controller can adjust the configuration of the catheter-based system based at least in part on a treatment plan, such as, for example, an initial treatment plan generated by the surgical database 499 (which is then based on pre-treatment data collected, for example, in the treatment room 420, and transmitted to the control room 410 for communication with and / or from the surgical database 499) or an intermediate or modified treatment plan generated by the surgical database 499 (which is then based on pre-treatment data and / or treatment session data collected, for example, in the treatment room 420, and transmitted to the control room 410 for communication with and / or from the surgical database 499).

[0139] The device position controller can be used to adjust the position of the device, i.e., one or more aspects of the catheter-based system, relative to the cardiovascular tissue being treated, e.g., adjusting the catheter position to move an angioplasty balloon or cardiac tissue compliant element, etc., more proximally or more distally. The patient information can include a display of any important patient data related to the treatment, such as, for example, information regarding the treatment site, patient age, disease state, vital sign measurements (such as blood pressure or pulse oximeter readings), for review by a clinician or operator.

[0140] The surgery database 499 (i.e., the catheter-based surgery information module) includes relevant information about past treatment plans (i.e., information related to the configuration of the catheter-based system for treating cardiovascular tissue, such as oscillation frequency, duty cycle and / or amplitude and corresponding details about the underlying cardiovascular tissue, such as the degree of calcification), which can be accessed to identify potential treatment plans related to new treatments. The surgery database 499 can be configured to generate treatment plans using any convenient technique, i.e., a treatment planning algorithm, such as, for example, a lookup-based algorithm that employs matching aspects of the current surgery with past surgeries recorded in the surgery database 499, or a model-based approach for estimating an optimal treatment plan including a system-based configuration, such as, for example, a statistical model or a machine learning model, including, for example, a neural network model or a deep learning model, including, for example, a convolutional neural network model. In embodiments, such a treatment generation algorithm including a machine learning algorithm can be trained using past data and results of catheter-based surgeries. In some cases, such a treatment generation algorithm can be configured to continuously train such a surgery on a rolling basis as such a surgery is performed, based on data and results collected from the catheter-based surgery. The surgical database 499 (ie, the catheter-based surgical information module) may be implemented on a computer system present in the control room 410 , or may be implemented on a computer system present at a remote location and accessed via the computer system present in the control room 410 .

[0141] Treatment locations 420 may include, for example, Figure 1 , i.e., an embodiment of a system of a catheter-based system 100 as depicted in FIG. 4, i.e., a system including a console assembly having an electrical potential source, a manifold assembly, and a catheter assembly having a connector, a connector-catheter transition hub, a catheter, and a cardiac tissue compliant element. Treatment room 420 may be, for example, an operating room or a procedure room of a hospital or treatment center. Any convenient operable connection capable of transmitting data and control signals between treatment room 420 and control room 410 may be employed, such as a wired or wireless connection, such as via the Internet or via a private, dedicated network.

[0142] Compliance measurement :

[0143] As described in detail below, the compliance of a tissue (e.g., cardiovascular tissue or blood vessel) is a measurable property of a tissue (such as a blood vessel or cardiovascular tissue, such as cardiovascular tissue including a heart valve) that is calculated based on the ratio of tissue volume change for a given pressure change. Vascular compliance is an important property to observe because improving vascular compliance is a prerequisite for the ultimate treatment of certain underlying disease conditions, such as atherosclerosis or the presence of calcification in tissue such as cardiovascular tissue. In Figure 5 Changes in vascular compliance can be seen in the different pressure-volume curves depicted. Figure 5 In FIG, volume is plotted on the x-axis and pressure is plotted on the y-axis. Pressure-volume (i.e., vascular compliance), a characteristic of an unconstrained balloon (i.e., a balloon that is not present in the tissue or otherwise constrained from expanding its volume when balloon pressure is increased) relative to untreated (i.e., pre-treatment) tissue (i.e., an untreated vessel) relative to treated (i.e., post-treatment) tissue (e.g., a treated vessel).

[0144] like Figure 5 As shown, in treatment, for example, using an embodiment of a catheter-based system such as Figure 1 The depicted system 100 applies pulsed energy to cardiovascular tissue and the pressure-volume curve shifts to the right, closer to the curve for an unconstrained balloon. That is, during treatment, the same change in tissue volume corresponds to a reduced tissue pressure; that is, applying less pressure to the tissue can expand the tissue volume by a similar amount.

[0145] Methods and systems according to the present invention may be configured to assess the compliance of a cardiovascular tissue (eg, a blood vessel) by obtaining in vivo measurements of volume changes at different pressures (or different changes in pressure) applied to the tissue (eg, a blood vessel). Fig. 6A and Figure 6B Examples of measurements of changes in tissue compliance obtained during treatments including catheter-based procedures using catheter-based systems, such as e.g. Figure 1 The system 100 is depicted during pulse lithotripsy within a heart valve. Fig. 6A The use of dynamic changes in pressure to obtain a measure of tissue compliance, ie, the pressure applied to the tissue and the corresponding volume change over time, is demonstrated. Fig. 6A It is shown that the peak volume change trends upward while the peak applied pressure remains constant. That is, as treatment progresses, when the same pressure change is applied, the tissue volume increases to a greater extent, which is a sign of increased tissue compliance.

[0146] In an embodiment of a method according to the present invention, the pre-treatment data, the treatment period data, and the post-treatment data may include compliance measurements of the tissue (or data that may be processed together to produce compliance measurements). In an embodiment, the information transmitted to and / or transmitted from the catheter-based information module may include tissue compliance data. In such embodiments, the catheter-based surgery information module may include a treatment plan generation algorithm that generates a treatment plan, such as a revised treatment plan, based on the treatment period data, based on compliance measurements or changes in compliance measurements obtained during the application of the catheter-based surgery, or based on a target compliance target or target compliance change. In some cases, the catheter-based surgery information module may be configured to transmit a stop or end instruction so that the catheter-based surgery stops when the relevant tissue reaches a specified compliance value or a specified change in compliance. For example, the treatment plan may include, for example, Fig. 6A The instructions for applying cyclic pressure to the balloon are shown, and further instructions that if the corresponding balloon volume behaves as shown Fig. 6A As depicted, such behavior indicates a desired change in tissue compliance and the catheter-based procedure should be concluded.

[0147] Figure 6B It is demonstrated that dynamic changes in pressure as well as static pressure (i.e., at the third pressure oscillation, the pressure applied to the tissue is maintained for approximately half a cycle) are used to obtain a measure of tissue compliance, i.e., the pressure applied to the tissue and the corresponding volume change over time. Figure 6B It is shown that the peak volume change trends upward while the peak applied pressure remains constant. That is, as treatment progresses, when the same pressure change is applied, the tissue volume increases to a greater extent, which is a sign of increased tissue compliance.

[0148] Embodiments of the methods of the present invention may include transmitting in real time a measurement of a relative change in compliance of cardiovascular tissue (e.g., a blood vessel) during application of a catheter-based procedure to provide, for example, pulsed energy to the cardiovascular tissue. A system of interest for performing a catheter-based procedure of the present invention may be configured to measure and update treatment parameters based on changes in compliance of the cardiovascular tissue. For example, after a calcium rupture (i.e., a rupture of calcified plaque tissue), the cardiovascular tissue and angioplasty balloon or cardiac tissue compliance element or its balloon, etc. may expand significantly, as measured by the system, contributing to a greater increase in compliance. However, after the vessel is fully dilated, the change in compliance measured by the system may diminish. As defined in the treatment plan or identified by the catheter-based surgery information module, identification of such a condition (i.e., a change of varying degrees of compliance) may indicate that treatment may be stopped because no further significant gain occurs.

[0149] The catheter-based system used in the catheter-based procedures 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 channel and / or a balloon or catheter of an angioplasty balloon or cardiac tissue compliant element. In some examples, the pressure gauge can be installed so that it is configured to measure pressure at a connector (such as Figure 1 The pressure present in the connector 151).

[0150] The catheter-based system used in the catheter-based surgery of the present invention can be configured to measure volume changes of cardiovascular tissue (e.g., blood vessels) in any convenient manner. In some examples, embodiments of the system according to the present invention can be configured so that a separator, such as a connector (such as Figure 1 The change in the position of the membrane of the proximal chamber and the distal chamber of the connector 151 in the catheter-based system (such as the connector 151 in the catheter-based system) reflects the volume change of one aspect of the cardiac tissue compliance element (such as a balloon). The change in the volume of the balloon reflects the change in the cross-sectional area of ​​the cardiovascular tissue (such as a blood vessel), and therefore reflects the change in the volume of the cardiovascular tissue. Such a catheter-based system may also include a Hall sensor and a permanent magnet for measuring the position change of such a membrane. A Hall sensor refers to a sensor configured to sense the presence or change of a magnetic field, that is, by using the Hall effect. As required, the permanent magnet may include any convenient magnetic material or electromagnet so that the relative position change of the Hall sensor relative to the permanent magnet can be detected by the Hall sensor. Sensors such as the above-mentioned Hall sensors and permanent magnets can be used to measure the volume change of an angioplasty balloon or a cardiac tissue compliance element or one or more balloons of a catheter-based system for performing a catheter-based surgery in combination with an embodiment of the present invention, as well as the rate at which such angioplasty balloon or cardiac tissue compliance element (such as one or more balloons thereof) expands, that is, the rate of change in the volume of the cardiovascular tissue and the corresponding compliance change.

[0151] system

[0152] As described above, aspects of the present disclosure include systems configured for practicing the subject methods. According to some embodiments, the system includes a catheter-based surgery information module, which includes: a first processor, including a memory operably coupled to the first processor, wherein the memory includes instructions stored thereon, which instructions, when executed by the first processor, cause the first processor to: receive data about the catheter-based surgery from the catheter-based system, and transmit the data about the catheter-based surgery to the catheter-based system. According to some embodiments, the system also includes a catheter-based system, which includes: a catheter-based device; a second processor, including a memory operably coupled to the second processor, wherein the memory includes instructions stored thereon, which instructions, when executed by the second processor, cause the second processor to: transmit data about the catheter-based surgery to the catheter-based surgery information module, receive data about the catheter-based surgery from the catheter-based surgery information module, and configure the catheter-based device based at least in part on the data about the catheter-based surgery received from the catheter-based surgery information module. According to some embodiments, the system also includes an operable connection between the catheter-based surgery information module and the catheter-based system. As described above, any convenient processor and memory can be used in embodiments of the present invention. In embodiments of the present invention, any convenient operable connection between the catheter-based surgical information module and the catheter-based system may be employed, such as a wired or wireless computer network connection as described above.

[0153] Catheter-based surgery information module :

[0154] In an embodiment of the system of the present invention, the catheter-based surgical information module is remote from the catheter-based system. "Remote" means that the catheter-based surgical information module is different from the catheter-based system and is separate from the catheter-based system, for example, on a different side of a partition in a room or in a different room of a building, a different building, a different city, or a different country. In other cases, the catheter-based surgical information module is integrated into the catheter-based system.

[0155] In some cases, the catheter-based surgery information module is configured to store data about the catheter-based surgery. For example, the catheter-based surgery information module can be configured to store pre-treatment information, during-treatment information, or post-treatment information, i.e., outcome information related to the catheter-based surgery. In other cases, the catheter-based surgery information module is configured to store data about the catheter-based surgery in a distributed data storage. "Distributed data storage" means that data about the catheter-based surgery can be stored in more than one storage location or node of a computer network, where the nodes can include separate physical locations, including, for example, cloud-based data storage.

[0156] Embodiments of the system of the present invention may include more than one catheter-based system and be configured such that the catheter-based surgical information module interfaces with each catheter-based system. That is, in an example, the catheter-based system is a first catheter-based system, and the catheter-based surgical information module is configured to receive data from and transmit data to the plurality of catheter-based systems. In some cases, in such examples, at least two of the plurality of catheter-based systems are located at different locations, such as, for example, different catheter-based surgical treatment locations.

[0157] Treatment Information :

[0158] In an embodiment of the system according to the present invention, in each case, the data about the catheter-based surgery transmitted to the catheter-based surgery information module includes pre-treatment data, treatment period data and / or post-treatment data, as described above. In certain embodiments, the catheter-based device includes 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 includes balloon position, balloon deployment percentage, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure or position of the valve in the valve annulus, or any other measurement value related to the catheter-based surgery and capable of being detected by a sensor integrated into the catheter-based system.

[0159] Treatment plan :

[0160] In an embodiment of the system according to the invention, the first processor memory further comprises instructions that, when executed by the first processor, further 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 received from the catheter-based system regarding the catheter-based procedure. In other embodiments, the data transmitted by the catheter-based procedure information module comprises the treatment plan.

[0161] As described above, the treatment plan can 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 the data about the catheter-based procedure with data from a previous catheter-based procedure. In other embodiments, the treatment plan generation algorithm is configured to access data sets about multiple previous catheter-based procedures. In some cases, the treatment plan generation algorithm includes a machine learning algorithm component that can be trained using data from one or more catheter-based procedures, such as catheter-based procedures previously performed on the same or different subjects at one or more locations.

[0162] With respect to applying the treatment plan, in some embodiments, configuring the catheter-based device based at least in part on the data regarding the catheter-based surgery received from the catheter-based surgery information module includes configuring the catheter-based device based at least in part on the treatment plan. In some cases, configuring the catheter-based device includes applying an initial configuration for the catheter-based surgery. In other cases, configuring the catheter-based device includes reconfiguring the catheter-based device.

[0163] With respect to configuring the catheter-based device, in embodiments, configuring the catheter-based device includes, for example, selecting a treatment type, treatment duration, treatment intensity, or treatment frequency. In some cases, configuring the catheter-based device includes automatically adjusting the configuration of the catheter-based device. In other cases, configuring the catheter-based device includes presenting changes to the configuration of the catheter-based device for operator approval. By presenting the changes for operator approval, it is meant, for example, displaying the proposed configuration on an output device, such as a monitor or display, such as a touch screen display, and receiving input indicating approval or modification (i.e., a change in an aspect of the treatment plan), such as touching one or more keys on a touch screen display.

[0164] Catheter-based surgery :

[0165] In an embodiment of the system of the present invention, the catheter-based system may include any convenient catheter-based device, such as, for example, a catheter-based device used in conjunction with an interventional treatment of cardiovascular tissue, such as, for example, a balloon catheter device, and this may vary as desired. In some embodiments, the catheter-based device includes a pulse balloon catheter system. More details about this catheter-based device that can be used in conjunction with the method system described herein are provided in U.S. Patent Application No. 63274832, the disclosure of which is incorporated herein by reference. In other embodiments, the catheter-based device includes a microcatheter system for passing through a complete occlusion. Further details about this catheter-based surgery that can be used in conjunction with the method and system described herein are provided in U.S. Application No. 63238381, the disclosure of which is incorporated herein by reference. In other embodiments, the catheter-based device includes a system for applying pulsed energy to heart valve tissue. Further details regarding such catheter-based procedures that may be used in conjunction with the methods and systems are described in U.S. application serial number 63,346,703, entitled “SYSTEMS AND METHODS FOR TREATING CARDIOVASCULAR TISSUE,” and filed on the same date as the present application (Attorney Docket No. AVSI-004PRV); the disclosure of that application is incorporated herein by reference.

[0166] Computer readable storage medium

[0167] Aspects of the present disclosure also include non-transitory computer-readable storage media with instructions for practicing the subject method. Computer-readable storage media can be used on one or more computers for full or partial automation of the system for practicing the method described herein. In some embodiments, instructions according to the method described herein can be encoded on a computer-readable medium in the form of "programming", where the term "computer-readable medium" used herein refers to any non-transitory storage medium that participates in providing instructions and data to a computer for execution and processing. Any suitable non-transitory storage medium can be used, such as a floppy disk, a hard disk, an optical disk, a magneto-optical disk, a CD-ROM, a CD-R, a tape, a non-volatile memory card, a ROM, a DVD-ROM, a Blu-ray disc, a solid-state disk, and a network-attached storage (NAS), whether these devices are inside or outside the computer. Files containing information can be "stored" on a computer-readable medium, where "storage" means recording information so that it can be accessed and retrieved by a computer later.

[0168] The following examples are offered by way of illustration and not by way of limitation.

[0169] Example

[0170] Using the measured system characteristics in conjunction with a model of a catheter-based system, embodiments of the present invention may be used 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. Figure 7 Two examples of experimentally measured pressures in a balloon of a catheter-based system for performing catheter-based surgery and forces output from such a balloon are shown in FIG. A system model can be used to accurately predict experimental measurements. Using such a predictive model and feedback from system measurements (e.g., treatment period data such as sensor data as described above), surgical characteristics (frequency, pressure input, and duty cycle) can be adjusted to ensure maximized treatment effects. In addition to utilizing these features of embodiments of the present invention to promote more effective catheter-based surgery by, for example, optimizing changes in balloon pressure, these features can also be used to improve the safety of catheter-based surgery. For example, a significant change in the pressure and / or volume of the balloon detected by a sensor in or associated with a catheter-based system can cause a catheter-based information module or another controller as an embodiment of the present invention to automatically shut down the catheter-based system to prevent a safety hazard.

[0171] Figure 8An example application for controlling a catheter-based surgery is shown. During a catheter-based surgery, the balloon of the catheter-based system is periodically pressurized over time, and the balloon decompression pressure falls outside a desired range. When this occurs, the catheter-based information module (i.e., a control algorithm for a catheter-based system for controlling a catheter-based surgery) works to reduce the oscillation frequency (i.e., periodic balloon pressurization) so that the balloon has enough time to decompress and reach a suitable pressure range.

[0172] Fig. 9 Exemplary images of calcification in luminal tissue before and after application of a catheter-based procedure (pre-treatment and post-treatment) are presented. The effect of applying an optimal treatment plan for controlling the catheter-based procedure can be seen in the post-treatment image, where calcification has been destroyed in several locations due to application of the catheter-based procedure according to an embodiment of the present invention.

[0173] Fig.10 A table summarizing the effectiveness of a catheter-based surgical approach based on a peripheral intravenous line (PIVL) under different conditions is shown. The four quadrants of the table present metrics for different situations based on when treatment (i.e., catheter-based surgery) is administered and when such treatment may be most effective. Embodiments of the catheter-based information module may be configured to apply such metrics when generating a treatment plan. In some cases, the thickness of a crack in a calcium deposit may be considered a treatment target, and a treatment plan generated by the catheter-based information module may be based at least in part on this target. For example, crack thickness may be a function of treatment time and pulse energy applied via the catheter-based surgery.

[0174] Fig.11 An exemplary X-ray image showing calcium deposits in tissue is depicted. Such X-ray imaging may include information transmitted 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. Fig.11 The X-ray images shown provide information about the density of calcium deposits so that the catheter-based information module can respond accordingly in the generated treatment plan; that is, the calcium density or hardness of the calcium deposits can be indicated in the X-ray image, such as in the grayscale output based on the X-ray. Fig.11 Based on Fig.11Based on one or more images shown, the catheter-based information module can determine (i.e., modify or optimize) the energy to be applied to such calcium deposits. For example, the catheter-based information module can generate a treatment plan for applying lower pressures during a catheter-based procedure based on images depicting smaller diameter calcium deposits. Similarly, ultrasound images can be used to measure vascular strain, and such strain measurements can be applied by the catheter-based information module to help configure, for example, the amount of force applied during a catheter-based procedure or some other treatment configuration. In some cases, intravascular ultrasound images can be used to determine differences in strain at different locations within a vessel. The catheter-based information module can apply such characteristic differences at different locations of the vessel to help configure, for example, the amount of force applied during a catheter-based procedure or some other treatment configuration.

[0175] Notwithstanding the appended claims, the present disclosure is defined by the following clauses:

[0176] 1. A method comprising:

[0177] Perform catheter-based procedures; and

[0178] Data regarding the catheter-based procedure is communicated to and / or from a catheter-based procedure information module.

[0179] 2. The method of clause 1, wherein the catheter-based surgical information module is a remote module.

[0180] 3. The method according to any of the preceding clauses, wherein the catheter-based procedure information module is configured to store data regarding the catheter-based procedure.

[0181] 4. The method of clause 3, wherein the catheter-based surgical information module comprises a distributed data store.

[0182] 5. A method according to any one of clauses 3 to 4, wherein the catheter-based surgical information module comprises a cloud-based data storage.

[0183] 6. The method according to any of the preceding clauses, wherein the catheter-based procedure information module is configured to receive and / or transmit data regarding a plurality of catheter-based procedures.

[0184] 7. The method of clause 6, wherein at least two of the plurality of catheter-based procedures are performed at different locations.

[0185] 8. The method of clause 7, wherein the different locations comprise different catheter-based surgical treatment locations.

[0186] 9. The method according to any of the preceding clauses, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises pre-treatment data.

[0187] 10. The method of clause 9, wherein the pre-treatment data comprises data collected prior to performing the catheter-based procedure.

[0188] 11. A method according to any one of clauses 9 to 10, wherein the pre-treatment data comprises pre-treatment imaging.

[0189] 12. The method of clause 11, wherein the pre-treatment imaging comprises angiography, computed tomography, optical coherence tomography, intravascular ultrasound, or echocardiography.

[0190] 13. A method according to any one of clauses 9 to 12, wherein the pre-treatment data comprises pre-treatment vital signs.

[0191] 14. The method of clause 13, wherein the pre-treatment vital signs include body temperature, pulse rate or respiratory rate.

[0192] 15. A method according to any one of clauses 9 to 14, wherein the pre-treatment data comprises pre-treatment measurements.

[0193] 16. The method of clause 15, wherein the pre-treatment measurements include ventricular pressure, aortic pressure, or an electrocardiogram.

[0194] 17. A method according to any preceding clause, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises treatment session data.

[0195] 18. The method of clause 17, wherein the treatment session data comprises data collected during the catheter-based procedure.

[0196] 19. A method according to any of clauses 17 to 18, wherein the treatment session data comprises catheter system sensor data.

[0197] 20. The method of clause 19, wherein the catheter system sensor data includes balloon position, balloon deployment percentage, valve opening, valve eccentricity, paravalvular leakage, peripheral pressure on the valve, proximal pressure, distal pressure, or position of the valve in the valve annulus.

[0198] 21. A method according to any of clauses 17 to 20, wherein the treatment session data comprises treatment session imaging.

[0199] 22. The method of clause 21, wherein the treatment period imaging comprises angiography, computed tomography, magnetic resonance imaging, optical coherence tomography, intravascular ultrasound, or echocardiography.

[0200] 23. A method according to any one of clauses 17 to 22, wherein the treatment session data comprises treatment session vital signs.

[0201] 24. The method of clause 23, wherein the vital signs measured during treatment include body temperature, pulse rate or respiratory rate.

[0202] 25. A method according to any one of clauses 17 to 24, wherein the treatment session data comprises treatment session measurements.

[0203] 26. A method according to clause 25, wherein the treatment period measurements include ventricular pressure, atrial pressure, aortic pressure, pressure in a coronary artery or arterial pressure in another vessel or an electrocardiogram.

[0204] 27. The method according to any of the preceding clauses, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises post-treatment data.

[0205] 28. The method of clause 27, wherein the post-treatment data comprises data collected after performing the catheter-based procedure.

[0206] 29. A method according to any of clauses 27 to 28, wherein the post-treatment data comprises catheter system sensor data.

[0207] 30. The method of clause 29, wherein the catheter system sensor data includes balloon position, balloon deployment percentage, valve opening, valve eccentricity, paravalvular leakage, peripheral pressure on the valve, proximal pressure, distal pressure, or position of the valve in the valve annulus.

[0208] 31. A method according to any one of clauses 27 to 30, wherein the post-treatment data comprises post-treatment imaging.

[0209] 32. The method of clause 31, wherein the post-treatment imaging comprises angiography, computed tomography, optical coherence tomography, magnetic resonance imaging, intravascular ultrasound, or echocardiography.

[0210] 33. A method according to any one of clauses 27 to 32, wherein the post-treatment data comprises post-treatment vital signs.

[0211] 34. The method of clause 32, wherein the post-treatment vital signs include body temperature, pulse rate, or respiratory rate.

[0212] 35. A method according to any one of clauses 27 to 34, wherein the post-treatment data comprises post-treatment measurements.

[0213] 36. The method of clause 34, wherein the post-treatment measurements include ventricular pressure, aortic pressure, or an electrocardiogram.

[0214] 37. A method according to any one of clauses 27 to 34, wherein the post-treatment data comprises outcome information.

[0215] 38. The method of clause 37, wherein the result information includes data regarding acute valve opening, valve compliance, intravascular pressure, or external pressure.

[0216] 39. The method of any of the preceding clauses, further comprising configuring the catheter-based procedure based at least in part on data transmitted from the catheter-based procedure information module.

[0217] 40. The method of any of the preceding clauses, wherein the catheter-based surgery information module is configured to implement a treatment plan generation algorithm.

[0218] 41. The method of clause 40, wherein the treatment plan generation algorithm is configured to generate a treatment plan based at least in part on data regarding the catheter-based procedure transmitted to the catheter-based procedure information module.

[0219] 42. The method of clause 41, wherein the data transmitted from the catheter-based surgical information module includes a treatment plan.

[0220] 43. A method according to any of clauses 40 to 42, wherein the treatment plan comprises configuration of a catheter-based system for performing the catheter-based procedure.

[0221] 44. The method of clause 43, wherein the configuration of the catheter-based system comprises a device type or a balloon type.

[0222] 45. A method according to any one of clauses 40 to 44, wherein the treatment plan comprises configuration of the catheter-based procedure.

[0223] 46. ​​The method of clause 45, wherein the configuration of the catheter-based procedure comprises treatment type, treatment duration, treatment intensity, or treatment frequency.

[0224] 47. A method according to any of clauses 40 to 46, wherein the treatment plan generation algorithm is configured to compare at least a subset of the data relating to the catheter-based procedure with data from previous catheter-based procedures.

[0225] 48. The method of clause 47, wherein the treatment plan generation algorithm is configured to access a data set regarding a plurality of previous catheter-based procedures.

[0226] 49. A method according to any one of clauses 40 to 46, wherein the treatment plan generation algorithm comprises a machine learning algorithm.

[0227] 50. The method of clause 49, further comprising training the machine learning algorithm with data regarding the catheter-based procedure.

[0228] 51. A method according to any of clauses 49 to 50, further comprising training the machine learning algorithm with data relating to a plurality of previous catheter-based procedures.

[0229] 52. The method of clause 51, wherein the data regarding previous catheter-based procedures comprises data from catheter-based procedures performed at a plurality of locations.

[0230] 53. The method of any one of clauses 38 to 52, further comprising configuring the catheter-based procedure based at least in part on the treatment plan.

[0231] 54. The method of clause 53, wherein configuring the catheter-based procedure comprises applying an initial configuration for the catheter-based procedure.

[0232] 55. The method of any one of clauses 53 to 54, wherein configuring the catheter-based procedure comprises reconfiguring the catheter-based procedure while performing the catheter-based procedure.

[0233] 56. A method according to any of clauses 53 to 55, wherein configuring the catheter-based procedure comprises selecting a treatment type, treatment duration, treatment intensity or treatment frequency.

[0234] 57. The method of clause 56, wherein configuring the catheter-based procedure comprises automatically adjusting a configuration of a catheter-based system.

[0235] 58. The method of clause 57, wherein configuring the catheter-based procedure comprises presenting changes to the configuration of the catheter-based system for operator approval.

[0236] 59. The method of any preceding clause, wherein the catheter-based procedure comprises a method of applying pulsed energy to an intraluminal tissue site.

[0237] 60. The method of clause 59, wherein the catheter-based procedure comprises use of a pulsatile balloon catheter system.

[0238] 61. A method according to any one of clauses 1 to 58, wherein the catheter-based procedure comprises a method of traversing a total occlusion.

[0239] 62. The method of clause 61, wherein the catheter-based procedure comprises applying a microcatheter system to penetrate the total occlusion.

[0240] 63. A method according to any one of clauses 1 to 58, wherein the catheter-based procedure comprises a method of applying pulsed energy to heart valve tissue.

[0241] 64. The method of clause 63, wherein the catheter-based procedure comprises applying a system for applying pulsed energy to heart valve tissue.

[0242] 65. A method according to any of the preceding clauses, wherein the catheter-based procedure is performed on a subject.

[0243] 66. The method of clause 65, wherein the subject is a mammal.

[0244] 67. The method according to clause 66, wherein the subject is a human.

[0245] 68. A system comprising:

[0246] Catheter-based procedure information module, including:

[0247] a first processor comprising a memory operatively coupled to the first processor, wherein the memory comprises instructions stored thereon that, when executed by the first processor, cause the first processor to:

[0248] receiving data regarding the catheter-based procedure from the catheter-based system; and

[0249] transmitting data regarding the catheter-based procedure to the catheter-based system;

[0250] Catheter-based systems, including:

[0251] catheter-based devices;

[0252] a second processor comprising a memory operatively coupled to the second processor, wherein the memory comprises instructions stored thereon that, when executed by the second processor, cause the second processor to:

[0253] transmitting data regarding the catheter-based procedure to the catheter-based procedure information module;

[0254] receiving data regarding the catheter-based procedure from the catheter-based procedure information module; and

[0255] configuring the catheter-based device based at least in part on data regarding the catheter-based procedure received from the catheter-based procedure information module; and

[0256] An operable connection between the catheter-based surgical information module and the catheter-based system.

[0257] 69. The system of clause 68, wherein the catheter-based surgical information module is remote from the catheter-based system.

[0258] 70. The system of any of clauses 68 to 69, wherein the catheter-based procedure information module is configured to store data regarding the catheter-based procedure.

[0259] 71. The system of clause 70, wherein the catheter-based surgery information module is configured to store data regarding the catheter-based surgery in a distributed data store.

[0260] 72. The system of any of clauses 70 to 71, wherein the catheter-based procedure information module is configured to store data regarding the catheter-based procedure in a cloud-based data storage.

[0261] 73. A system according to any one of clauses 68 to 72, wherein

[0262] The catheter-based system is a first catheter-based system; and

[0263] The catheter-based surgical information module is configured to receive data from and transmit data to a plurality of catheter-based systems.

[0264] 74. The system of clause 73, wherein at least two of the plurality of catheter-based systems are located at different locations.

[0265] 75. The system of clause 74, wherein the different locations comprise different catheter-based surgical treatment locations.

[0266] 76. The system of any of clauses 68 to 75, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises pre-treatment data.

[0267] 77. The system of clause 76, wherein the pre-treatment data comprises data collected prior to performing the catheter-based procedure.

[0268] 78. A system according to any of clauses 76 to 77, wherein the pre-treatment data comprises pre-treatment imaging.

[0269] 79. The system of clause 78, wherein the pre-treatment imaging comprises angiographic imaging, computed tomography imaging, optical coherence tomography imaging, intravascular ultrasound imaging, or echocardiographic imaging.

[0270] 80. A system according to any of clauses 76 to 79, wherein the pre-treatment data comprises pre-treatment vital signs.

[0271] 81. The system of clause 80, wherein the pre-treatment vital signs include body temperature, pulse rate, or respiratory rate.

[0272] 82. A system according to any of clauses 76 to 81, wherein the pre-treatment data comprises pre-treatment measurements.

[0273] 83. The system of clause 82, wherein the pre-treatment measurements include ventricular pressure, aortic pressure, or an electrocardiogram.

[0274] 84. The system of any of clauses 68 to 83, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises treatment session data.

[0275] 85. The system of clause 84, wherein the treatment session data comprises data collected during the catheter-based procedure.

[0276] 86. A system according to any one of clauses 84 to 85, wherein

[0277] The catheter-based device includes a sensor, and

[0278] The treatment session data includes catheter-based device sensor data.

[0279] 87. The system of clause 86, wherein the catheter-based device sensor data comprises balloon position, balloon deployment percentage, valve opening, valve eccentricity, paravalvular leakage, paravalvular pressure, proximal pressure, distal pressure, or valve position in the valve annulus.

[0280] 88. A system according to any of clauses 84 to 87, wherein the treatment session data comprises treatment session imaging.

[0281] 89. The system of clause 88, wherein the treatment period imaging comprises angiography, computed tomography, magnetic resonance imaging, optical coherence tomography, intravascular ultrasound, or echocardiography.

[0282] 90. A system according to any of clauses 84 to 89, wherein the treatment session data comprises treatment session vital signs.

[0283] 91. The system of clause 90, wherein the therapeutic vital signs include body temperature, pulse rate, or respiratory rate.

[0284] 92. A system according to any of clauses 84 to 91, wherein the treatment session data comprises treatment session measurements.

[0285] 93. The system of clause 92, wherein the treatment period measurements include ventricular pressure, atrial pressure, aortic pressure, coronary pressure, or arterial pressure in another vessel or an electrocardiogram.

[0286] 94. A system according to any of clauses 68 to 93, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises post-treatment data.

[0287] 95. The system of clause 94, wherein the post-treatment data comprises data collected after performing the catheter-based procedure.

[0288] 96. A system according to any one of clauses 94 to 95, wherein

[0289] The catheter-based device includes a sensor, and

[0290] The post-treatment data includes catheter-based device sensor data.

[0291] 97. The system of clause 96, wherein the catheter-based device sensor data comprises balloon position, balloon deployment percentage, valve opening amount, valve eccentricity, paravalvular leakage, peripheral pressure on the valve, proximal pressure, distal pressure, or position of the valve in the valve annulus.

[0292] 98. A system according to any of clauses 94 to 97, wherein the post-treatment data comprises post-treatment imaging.

[0293] 99. The system of clause 98, wherein the post-treatment imaging comprises angiography, computed tomography, optical coherence tomography, magnetic resonance imaging, intravascular ultrasound, or echocardiography.

[0294] 100. A system according to any of clauses 94 to 99, wherein the post-treatment data comprises post-treatment vital signs.

[0295] 101. The system of clause 99, wherein the post-treatment vital signs include body temperature, pulse rate, or respiratory rate.

[0296] 102. A system according to any of clauses 94 to 101, wherein the post-treatment data comprises post-treatment measurements.

[0297] 103. The system of clause 102, wherein the post-treatment measurements include ventricular pressure, aortic pressure, or an electrocardiogram.

[0298] 104. A system according to any of clauses 94 to 103, wherein the post-treatment data includes outcome information.

[0299] 105. The system of clause 104, wherein the result information includes data regarding acute valve opening, valve compliance, intravascular pressure, or external pressure.

[0300] 106. A system according to any of clauses 68 to 105, wherein the first processor memory further comprises instructions which, when executed by the first processor, further cause the first processor to apply a treatment plan generation algorithm.

[0301] 107. The system of clause 106, wherein the treatment plan generation algorithm is configured to generate a treatment plan based at least in part on data regarding the catheter-based procedure received from the catheter-based system.

[0302] 108. The system of clause 107, wherein the data transmitted by the catheter-based surgical information module comprises a treatment plan.

[0303] 109. A system according to any of clauses 106 to 108, wherein the treatment plan includes device type, balloon type, treatment type, treatment duration, treatment intensity, or treatment frequency.

[0304] 110. A system according to any of clauses 106 to 109, wherein the treatment plan generation algorithm is configured to compare at least a subset of the data regarding the catheter-based procedure with data from previous catheter-based procedures.

[0305] 111. The system of clause 110, wherein the treatment plan generation algorithm is configured to access a data set regarding a plurality of previous catheter-based procedures.

[0306] 112. A system according to any of clauses 106 to 111, wherein the treatment plan generation algorithm includes a machine learning algorithm component.

[0307] 113. The system of clause 112, wherein the treatment plan generation algorithm further comprises training the machine learning algorithm component with data regarding the catheter-based procedure.

[0308] 114. A system according to any of clauses 112 to 113, wherein the treatment plan generation algorithm further comprises training the machine learning algorithm component with data regarding a plurality of previous catheter-based procedures.

[0309] 115. The system of clause 114, wherein the data regarding previous catheter-based procedures comprises data from catheter-based procedures performed at a plurality of locations.

[0310] 116. The system of any of clauses 106 to 115, wherein configuring the catheter-based device based at least in part on data regarding the catheter-based procedure received from the catheter-based procedure information module comprises configuring the catheter-based device based at least in part on the treatment plan.

[0311] 117. The system of clause 116, wherein configuring the catheter-based device comprises initial configuration for the catheter-based surgical application.

[0312] 118. The system of any of clauses 116 to 117, wherein configuring the catheter-based device comprises reconfiguring the catheter-based device.

[0313] 119. A system according to any of clauses 116 to 118, wherein configuring the catheter-based device comprises selecting a type of treatment, a duration of treatment, an intensity of treatment, or a frequency of treatment.

[0314] 120. The system of clause 119, wherein configuring the catheter-based device comprises automatically adjusting a configuration of the catheter-based device.

[0315] 121. The system of clause 120, wherein configuring the catheter-based device comprises presenting changes to the configuration of the catheter-based device for operator approval.

[0316] 122. A system according to any one of clauses 68 to 121, wherein the catheter-based device comprises a pulsatile balloon catheter system.

[0317] 123. A system according to any one of clauses 68 to 121, wherein the catheter-based device comprises a microcatheter system for crossing a total occlusion.

[0318] 124. A system according to any of clauses 68 to 121, wherein the catheter-based device comprises a system for applying pulsed energy to heart valve tissue.

[0319] 125. A non-transitory computer readable storage medium comprising instructions stored thereon for transmitting data regarding a catheter-based procedure to and / or from a catheter-based procedure information module, the instructions comprising:

[0320] an algorithm for receiving data regarding a catheter-based procedure from a catheter-based system; and

[0321] An algorithm for transmitting data regarding a catheter-based procedure to the catheter-based system.

[0322] 126. The non-transitory computer-readable storage medium of clause 125, comprising instructions stored thereon, the instructions further comprising:

[0323] An algorithm for storing data related to the catheter-based procedure.

[0324] 127. A non-transitory computer-readable storage medium according to any one of clauses 125 to 126, wherein

[0325] The algorithm for receiving data regarding the catheter-based procedure includes an algorithm for receiving data from a plurality of catheter-based systems, and

[0326] Algorithms for transmitting data regarding a catheter-based procedure include algorithms for transmitting data to a plurality of catheter-based systems.

[0327] 128. The non-transitory computer-readable storage medium of any of clauses 125 to 127, wherein the data transmitted from the catheter-based system regarding the catheter-based procedure comprises pre-treatment data.

[0328] 129. The non-transitory computer-readable storage medium of clause 128, wherein the pre-treatment data comprises data collected prior to performing the catheter-based procedure.

[0329] 130. The non-transitory computer-readable storage medium of any of clauses 128 to 129, wherein the pre-treatment data comprises pre-treatment imaging.

[0330] 131. The non-transitory computer-readable storage medium of clause 130, wherein the pre-treatment imaging comprises angiographic imaging, computed tomography imaging, optical coherence tomography imaging, intravascular ultrasound imaging, or echocardiographic imaging.

[0331] 132. The non-transitory computer-readable storage medium of any one of clauses 128 to 131, wherein the pre-treatment data comprises pre-treatment vital signs.

[0332] 133. The non-transitory computer-readable storage medium of clause 132, wherein the pre-treatment vital signs include body temperature, pulse rate, or respiratory rate.

[0333] 134. The non-transitory computer-readable storage medium of any one of clauses 128 to 133, wherein the pre-treatment data comprises pre-treatment measurements.

[0334] 135. The non-transitory computer-readable storage medium of clause 134, wherein the pre-treatment measurement comprises ventricular pressure, aortic pressure, or an electrocardiogram.

[0335] 136. The non-transitory computer-readable storage medium of any of clauses 125 to 135, wherein the data transmitted from the catheter-based system regarding the catheter-based procedure comprises treatment session data.

[0336] 137. The non-transitory computer-readable storage medium of clause 136, wherein the treatment session data comprises data collected during the catheter-based procedure.

[0337] 138. The non-transitory computer-readable storage medium of any of clauses 136 to 137, wherein the treatment session data comprises catheter system sensor data.

[0338] 139. The non-transitory computer-readable storage medium of clause 138, wherein the catheter system sensor data comprises balloon position, balloon deployment percentage, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure, or position of the valve in the valve annulus.

[0339] 140. The non-transitory computer-readable storage medium of any one of clauses 136 to 139, wherein the treatment session data comprises treatment session imaging.

[0340] 141. The non-transitory computer-readable storage medium of clause 140, wherein the treatment period imaging comprises angiographic imaging, computed tomography imaging, magnetic resonance imaging, optical coherence tomography imaging, intravascular ultrasound imaging, or echocardiographic imaging.

[0341] 142. The non-transitory computer-readable storage medium of any one of clauses 136 to 141, wherein the treatment session data comprises treatment session vital signs.

[0342] 143. The non-transitory computer-readable storage medium of clause 142, wherein the during-treatment vital signs include body temperature, pulse rate, or respiratory rate.

[0343] 144. The non-transitory computer-readable storage medium of any one of clauses 136 to 143, wherein the treatment session data comprises treatment session measurements.

[0344] 145. The non-transitory computer-readable storage medium of clause 144, wherein the therapy session measurements include ventricular pressure, atrial pressure, aortic pressure, pressure in a coronary artery, or arterial pressure in another vessel, or an electrocardiogram.

[0345] 146. The non-transitory computer-readable storage medium of any of clauses 125 to 145, wherein the data transmitted from the catheter-based system regarding the catheter-based procedure comprises post-treatment data.

[0346] 147. The non-transitory computer-readable storage medium of clause 146, wherein the post-treatment data comprises data collected after performing the catheter-based procedure.

[0347] 148. The non-transitory computer-readable storage medium of any one of clauses 146 to 147, wherein the post-treatment data comprises catheter system sensor data.

[0348] 149. The non-transitory computer-readable storage medium of clause 148, wherein the catheter system sensor data comprises balloon position, balloon deployment percentage, valve opening amount, valve eccentricity, paravalvular leakage, ambient pressure on the valve, proximal pressure, distal pressure, or position of the valve in the valve annulus.

[0349] 150. The non-transitory computer-readable storage medium of any one of clauses 146 to 149, wherein the post-treatment data comprises post-treatment imaging.

[0350] 151. The non-transitory computer-readable storage medium of clause 150, wherein the post-treatment imaging comprises angiographic imaging, computed tomography imaging, optical coherence tomography imaging, magnetic resonance imaging, intravascular ultrasound imaging, or echocardiographic imaging.

[0351] 152. The non-transitory computer-readable storage medium of any one of clauses 146 to 151, wherein the post-treatment data comprises post-treatment vital signs.

[0352] 153. The non-transitory computer-readable storage medium of clause 152, wherein the post-treatment vital signs include body temperature, pulse rate, or respiratory rate.

[0353] 154. The non-transitory computer-readable storage medium of any one of clauses 146 to 153, wherein the post-treatment data comprises post-treatment measurements.

[0354] 155. The non-transitory computer-readable storage medium of clause 154, wherein the post-treatment measurement comprises ventricular pressure, aortic pressure, or an electrocardiogram.

[0355] 156. The non-transitory computer-readable storage medium of any one of clauses 146 to 155, wherein the post-treatment data comprises outcome information.

[0356] 157. The non-transitory computer-readable storage medium of clause 156, wherein the outcome information comprises data regarding acute valve opening, valve compliance, intravascular pressure, or external pressure.

[0357] 158. A non-transitory computer-readable storage medium according to any one of clauses 125 to 157, comprising instructions stored thereon, the instructions further comprising:

[0358] Treatment plan generation algorithm.

[0359] 159. The non-transitory computer-readable storage medium of clause 158, wherein the algorithm for treatment plan generation is configured to generate a treatment plan based at least in part on data regarding the catheter-based procedure received from the catheter-based system.

[0360] 160. The non-transitory computer-readable storage medium of clause 159, wherein the algorithm for transmitting data related to a catheter-based procedure comprises transmitting a treatment plan.

[0361] 161. The non-transitory computer-readable storage medium of any of clauses 158 to 160, wherein the treatment plan comprises a configuration of the catheter-based system for performing the catheter-based procedure.

[0362] 162. The non-transitory computer-readable storage medium of clause 161, wherein the configuration of the catheter-based system comprises a device type or a balloon type.

[0363] 163. The non-transitory computer-readable storage medium of any one of clauses 158 to 162, wherein the treatment plan comprises a configuration of the catheter-based procedure.

[0364] 164. The non-transitory computer-readable storage medium of clause 163, wherein the configuration of the catheter-based procedure comprises a treatment type, a treatment duration, a treatment intensity, or a treatment frequency.

[0365] 165. The non-transitory computer-readable storage medium of any of clauses 158 to 164, wherein the algorithm for treatment plan generation is configured to compare at least a subset of the data regarding the catheter-based procedure with data from a previous catheter-based procedure.

[0366] 166. The non-transitory computer-readable storage medium of clause 165, wherein the algorithm for treatment plan generation is configured to access a data set regarding a plurality of previous catheter-based procedures.

[0367] 167. The non-transitory computer-readable storage medium of any of clauses 158 to 166, wherein the algorithm for treatment plan generation comprises a machine learning algorithm.

[0368] 168. The non-transitory computer-readable storage medium of clause 167, wherein the algorithm for treatment plan generation is configured to train the machine learning algorithm with data regarding the catheter-based procedure.

[0369] 169. The non-transitory computer-readable storage medium of any of clauses 167 to 168, wherein the algorithm for treatment plan generation is configured to train the machine learning algorithm with data regarding a plurality of previous catheter-based procedures.

[0370] 170. The non-transitory computer-readable storage medium of clause 169, wherein the data regarding previous catheter-based procedures comprises data from catheter-based procedures performed at a plurality of locations.

[0371] In at least some of the previously described embodiments, one or more elements used in one embodiment may be used interchangeably in another embodiment, unless such replacement is technically infeasible. It will be appreciated by those skilled in the art that various other omissions, additions, and modifications may be made to the above methods and structures without departing from the scope of the claimed subject matter. All of these modifications and variations are intended to fall within the scope of the subject matter defined by the appended claims.

[0372] Those skilled in the art will understand that, in general, the terms used herein, and particularly in the appended claims (e.g., the bodies of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "including but not limited to," etc.). Those skilled in the art will further understand that if a specific number of claim recitations is intended to be introduced, such intent will be explicitly recited in the claim, and if no such recitation is present, no such intent is present. For example, to aid understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be interpreted as implying that a claim recitation introduced by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim recitations. Furthermore, even if a specific number of introduced claim recitations is explicitly recited, one skilled in the art will recognize that such recitation should be interpreted as meaning at least the number of recitations (e.g., the simple recitation of "two recitations" without other modifiers means at least two recitations, or two or more recitations). In addition, in those cases similar to the convention of "at least one of A, B, and C, etc.", in general, such construction is intended to make the convention understood by those skilled in the art (e.g., "a system having at least one of A, B, and C" will include but is not limited to systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In the case of the convention of "at least one of A, B, or C, etc.", in general, such construction is intended to make the convention understood by those skilled in the art (e.g., "a system having at least one of A, B, or C" will include but is not limited to systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will further understand that, whether in the specification, claims, or drawings, virtually any disjunctive word and / or phrase indicating two or more optional terms should be understood to contemplate the possibility of including one term, one term, or both terms. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B".

[0373] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0374] As will be understood by those skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also include any and all possible sub-ranges and combinations of sub-ranges thereof. Any listed range can be easily considered to fully describe and be able to divide the same range into at least equal halves, one-third, one-quarter, one-fifth, one-tenth, etc. As a non-limiting example, each range discussed herein can be easily decomposed into the last third, the middle third, and the first third, etc. It will also be understood by those skilled in the art that all languages ​​(such as "at most", "at least", "greater than", "less than", etc.) include the numbers listed, and refer to the ranges that can be subsequently decomposed into sub-ranges as described above. Finally, as will be understood by those skilled in the art, the range includes each individual member. Therefore, for example, a group with 1 to 3 items refers to a group with 1, 2 or 3 items. Similarly, a group with 1 to 5 items refers to a group with 1, 2, 3, 4 or 5 items, etc.

[0375] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be apparent to one skilled in the art that certain changes and modifications may be made thereto in light of the teachings of the invention without departing from the spirit or scope of the appended claims.

[0376] Therefore, the above merely illustrates the principle of the present invention.It should be understood that those skilled in the art will be able to design a variety of arrangements, although such arrangements are not explicitly described or shown here, but embody the principle of the present invention and be included in the spirit and scope of the present invention.In addition, all examples and conditional language recorded herein are mainly intended to help readers understand the principles of the present invention and the concepts that the inventors contribute to advance the prior art, and should be interpreted as not being limited to these specifically described examples.In addition, all statements of the principles, aspects, and embodiments of the present invention and its specific examples recorded herein are intended to cover the equivalents of their structures and functions.In addition, it is intended that such equivalents include currently known equivalents and equivalents developed in the future, that is, any element of the development that performs the same function, regardless of the structure.In addition, anything disclosed herein is not intended to be disclosed to the public, regardless of whether such disclosure is clearly described in the claims.

[0377] Therefore, the scope of the present invention is not intended to be limited to the exemplary embodiments shown and described herein. Instead, the scope and spirit of the present invention are embodied by the appended claims. In the claims, 35 USC §112(f) or 35 USC §112(6) is expressly defined to be invoked for limitation in the claims only when the exact phrase "means" or the exact phrase "step" is cited at the beginning of such limitation in the claim; if such exact phrase is not used in the limitation of the claim, 35 USC §112(f) or 35 USC §112(6) is not invoked.

Claims

1. A method comprising: performing catheter-based procedures; as well as Data regarding the catheter-based procedure is communicated to and / or from a catheter-based procedure information module.

2. The method of claim 1, wherein the catheter-based surgical information module is a remote module. 3 . The method of any one of the preceding claims, wherein the catheter-based surgery information module is configured to store data regarding the catheter-based surgery. 4 . The method of any 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.

5. The method of claim 4, wherein at least two of the plurality of catheter-based procedures are performed at different locations.

6. The method of any of the preceding claims, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises pre-treatment data.

7. The method of any of the preceding claims, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises treatment session data.

8. The method of any of the preceding claims, wherein the data regarding the catheter-based procedure transmitted to the catheter-based procedure information module comprises post-treatment data.

9. The method of any of the preceding claims, further comprising configuring the catheter-based procedure based at least in part on data communicated from the catheter-based procedure information module.

10. The method of any of the preceding claims, wherein the catheter-based surgery information module is configured to implement a treatment plan generation algorithm.

11. The method of claim 10, wherein the treatment plan generation algorithm is configured to generate a treatment plan based at least in part on data regarding the catheter-based procedure transmitted to the catheter-based procedure information module.

12. The method of claim 11, wherein the treatment plan includes a configuration of a catheter-based system for performing the catheter-based procedure.

13. The method of any one of claims 11 to 12, wherein the treatment plan generation algorithm is configured to compare at least a subset of the 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 data set regarding a plurality of previous catheter-based procedures.

15. A system comprising: Catheter-based procedure information module, including: a first processor comprising a memory operatively coupled to the first processor, wherein the memory comprises instructions stored thereon that, when executed by the first processor, cause the first processor to: receiving data regarding the catheter-based procedure from the catheter-based system; and transmitting data regarding the catheter-based procedure to the catheter-based system; Catheter-based systems, including: catheter-based devices; a second processor comprising a memory operatively coupled to the second processor, wherein the memory comprises instructions stored thereon that, when executed by the second processor, cause the second processor to: transmitting data regarding the catheter-based procedure to the catheter-based procedure information module; receiving data regarding the catheter-based procedure from the catheter-based procedure information module; and configuring the catheter-based device based at least in part on data regarding the catheter-based procedure received from the catheter-based procedure information module; and An operable connection between the catheter-based surgical information module and the catheter-based system.

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