Systems and methods for controlled delivery of energy by a catheter system based on a heartbeat cycle

Abstract

Systems and method are directed to an ability to provide greater control to the firing of IVL emitters based upon feedback data of the heartbeat of a subject patient. Preferably, the feedback data will allow for automated control of the actual high voltage pulse and thus the firing of one or more of the emitters. A specific purpose of controlling the emitter firing is to avoid firing the emitters at time where the heart is more vulnerable to altering the heartbeat of the patient. During a procedure in accordance with one aspect of the present invention, an electro-cardiogram (ECG or EKG) can be used to monitor the heartbeat of the patient. Another aspect is based on a timing of emitter firing based upon whether the particular valve being treated is moving toward the closed position or is in the closed position. Systole and diastole are two phases of the cardiac cycle that occur as the heart beats. Systole occurs when the heart contracts, pumping blood out, while diastole takes place when the heart relaxes after contraction.

Description

CSI0053WO (16037WOO3)SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLECross-Reference to Related Applications

[0001] This application claims priority to and the benefit of U. S. Provisional Application No. 63 / 754,798, filed February 6, 2025, and entitled SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLE, and U. S. Provisional Application No. 63 / 856,958, filed August 4, 2025, and entitled SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLE, the entire contents of which are incorporated herein by reference in their entireties.TECHNICAL FIELD

[0002] The present disclosure is directed to a catheter system for treating a calcified heart valve.BACKGROUND

[0003] The four chambers of a heart 10 (see FIG. 1) include two upper chambers that collect blood flowing into the heart and two lower chambers that pump blood out of the heart to the lungs or other parts of the body. Each chamber has a corresponding valve. Each valve has a set of flaps or leaflets which act as one-way inlets, when open, for letting blood into the corresponding chamber of the heart and when closed, for preventing backflow.

[0004] A tricuspid valve 12 is located between a right atrium 14 and a right ventricle 16 to allow blood to flow from the right atrium 14 into the right ventricle 16. A pulmonary valve 18 is located between the right ventricle 16 and a pulmonary artery 20 and regulates flow of oxygen-poor blood from the heart to the lungs. A mitral valve 22 (also known as a bicuspid or left atrioventricular valve) is located between a left atrium 24 and a left ventricle 26 to allow blood to flow from the left atrium 24 into the left ventricle 26. Lastly, an aortic valve 28 is located between the left ventricle 26 and an aorta 30, which is the largest blood vessel in the body for delivering oxygenated blood from the heart to the rest of the body. The aortic valve 28 opens to allow blood flow from the left ventricle 26 to the aorta 30.

[0005] FIG. 2 is a top view showing the four valves 12, 18, 22 and 28. The mitral valve 22 has two leaflets (or flaps) 32a and 32b. Each of the remaining valves has threeleaflets (or flaps) - specifically, the tricuspid valve 12 has leaflets 34a, 34b and 34c; the pulmonary valve 18 has leaflets 36a, 36b and 36c; and the aortic valve 28 has leaflets 38a, 38b and 38c.

[0006] Over time, a heart valve can become calcified, meaning that a large amount of calcium can be deposited on or around the valve. A calcified heart valve can become stiff and narrowed (stenotic), thereby resulting in increased resistance of blood flowing through the heart and overall increased load on the heart. More commonly, it is the left sided valves that calcify, relative to the valves on the right side of the heart. FIG. 3 shows the left side of the heart and more specifically, shows an uncalcified aortic valve 28 in an open position such that there is a sufficient opening for blood to flow from the left ventricle 26 into the aorta 30. By contrast, FIG. 4 shows a calcified aortic valve 28’ in an open position. Due to calcium lesions (or calcifications) 40 on and surrounding the leaflets of the aortic valve 28’, the valve 28’, when open, has a significantly narrower opening, compared to an uncalcified valve. This narrowing can lead to symptoms ranging from mild to severe, including chest pain, shortness of breath, fatigue etc.

[0007] The most common valve in patients needing repair is the aortic valve.Depending on the extent of the calcification, the aortic valve may be replaced with a synthetic valve, a tissue valve or other alternatives. For many patients, repair of the valve, particularly if non-invasive, may be preferable to valve replacement.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] These drawings are exemplary illustrations of certain embodiments and, as such, are not intended to limit the disclosure.

[0009] FIG. 1 is a schematic of a heart showing the chambers, valves and direction of blood flow.

[0010] FIG. 2 is a top view schematic of the heart of FIG. 1 showing the four heart valves.

[0011] FIG. 3 is a schematic of the left side of the heart of FIG. 1 showing the aortic valve in an open position.

[0012] FIG. 4 is a schematic of the left side of the heart showing a calcified aortic valve in an open position.

[0013] FIG. 5 illustrates a heart valve catheter system for performing high energy acoustic lithotripsy, according to one or more embodiments of the present disclosure.

[0014] FIG. 6 illustrates the heart valve catheter system of FIG. 5 in an inflated state inside the calcified aortic valve of FIG. 4 for providing valve repair, according to one or more embodiments of the present disclosure.

[0015] FIG. 7 illustrates another example of a heart valve catheter system inserted inside the heart for performing high energy acoustic lithotripsy, according to one or more embodiments of the present disclosure.

[0016] FIG. 8 is a graphical illustration of a typical ECG waveform for one heartbeat cycle of the heart;

[0017] FIG. 9 is a flowchart of a method and system in accordance with the present invention for controlling a firing of one or more emitters;

[0018] FIG. 10 is a schematic diagram of an electrical circuit and connection of the high voltage pulse generator to the emitters of a catheter system in accordance with the present invention.

[0019] FIG. 11 is a schematic diagram of another electrical circuit including shorting relays and connection of the high voltage pulse generator to the emitters of a catheter system in accordance with the present invention.

[0020] FIG. 12 is a chart indicating the positions of the relays of the circuit of FIG.11 to achieve all combinations of selective firing of the five emitters.

[0021] FIG. 13 is yet another electrical circuit including plural high voltage sources and connection of the high voltage pulse generator to the emitters of a catheter system in accordance with the present invention.

[0022] FIG. 14 is another chart indicating the positions of the relays of the circuit of FIG. 11 and the connections with plural high voltage sources to achieve all combinations of selective firing of the five emitters.

[0023] FIG. 15 is a view of a graphical user interface showing how a user can select emitters from plural emitters for selective firing, along with a high energy acoustic lithotripsy balloon and emitters and a heart showing a blood flow pattern through the heart.

[0024] FIG. 16 is a schematic cross-sectional view of the heart with an undersized inflatable balloon positioned within an aortic valve and with the valve leaflets in a closed state and in contact with the outer surface of the balloon.

[0025] FIG. 17 is a similar schematic view as FIG. 16 but showing valve leaflets spaced from the outer surface of the balloon with the valve leaflets in an open state while allowing blood flow around the balloon.DETAILED DESCRIPTION

[0026] The present disclosure is directed to a catheter system for treating a calcified heart valve. The heart valve catheter system includes an inflatable balloon that can be inflated with a conductive medium, such as saline, and one or more emitter, as each emitter comprises a pair of spaced electrodes, with at least one emitter electrically connected to a high voltage pulse generator. Such a high voltage pulse generator preferably can create one or a series of high voltage pulses of 2000 thousand volts or more. When a high voltage pulse is generated, a spark is created across the one or more pairs of electrodes that can be connected in series or parallel through the conductive medium to perform high energy acoustic lithotripsy of a heart valve region. In accordance with one aspect of the present invention, the spark in the inflated balloon results in an energy wave for breaking up calcifications on or around the calcified heart valve. The high energy acoustic lithotripsy catheter system described herein can be used as a less invasive alternative to valve replacement and at lower relative pressures than balloon valvuloplasty procedures. It may be used to break up calcified leaflets of a heart valve. It may be used on any of the four valves of a patient's heart. It may be used to prepare a heart valve region of a patent for a subsequent transcatheter heart valve replacement procedure. The use of the present invention is believed to reduce the chances of paraval ular leakage after a transcatheter heart valve replacement procedure.

[0027] Catheter systems having an angioplasty balloon have been commonly used to apply a physical force by expansion of the balloon against a calcified lesion within vasculature to force the calcification back into and against the blood vessel wall. Certain such calcified lesions and thrombi are not effectively broken up by the use of an angioplasty balloon alone. More recently, catheter systems have been developed that include a balloon similar to an angioplasty balloon that is filled with a conductive liquid medium, such as a saline solution, for expanding: the balloon in position at the lesion or thrombus, wherein the catheter system includes one or more pairs of electrodes (emitters) operatively positioned within the conductive liquid medium. The electrodes are pulsed with high voltage direct current so as to create a spark that jumps over a gap between the two electrodes of each emitter at each pulse. The spark within the conductive medium creates an energy wave that propagates through the liquid medium causing the balloon to physically provide a force against the lesion or thrombus. The energy propagation includes the creation of microbubbles that also facilitate the physical force. Such intravascular lithotripsy (high energy acoustic lithotripsy) devices can be provided in different designs and sizes, and utilize areusable power source such as a high energy pulse generator. Examples of IVL devices and systems can be found in the following patent applications: US Patent Application Pub. Nos.2024 / 0156478, 2024 / 0180569, and 2024 / 0307081; International Publication Numbers WO 2023 / 015047, WO 2024 / 138212, and WO 2024 / 107470, the entire contents of which are hereby incorporated by reference. Examples of power sources or generators or controllers useful for IVL procedures are described in published U. S. Patent Application Nos. 2024- 0180569 and 2025-0000532. The present invention is preferably compatible with or used with a high voltage energy source or generator (e.g. a high voltage pulse generator and controller) that is also able to provide energy for an IVL procedure and its associated catheters. The present invention may also be used with an energy source or generator or controller that is bespoken for procedures in the heart valve region of a patient.

[0028] The present disclosure focuses on using high energy acoustic lithotripsy for heart valves rather than a vascular application. As an example, one such device comprises a 0.014-inch guidewire-compatible, fluid-filled balloon catheter with two lithotripsy emitters incorporated into the shaft of a 12-mm-long balloon segment. A fluid filled balloon (e.g. a 50 / 50 saline contrast medium) is inflated to about 4 atm and then electrical pulses are provided to the emitters that create high voltage sparks to provide the therapy against the lesion. Acoustic waves (also referred to herein as high energy acoustic waves) are created and the calcium is fractured.

[0029] FIG. 5 shows a heart valve catheter system 100 for performing high energy acoustic lithotripsy according to the present invention and comprising a high voltage power source that is provided as a console 112 (in the form of a high voltage electrical pulse generator, but alternatively in the form of a laser system), a controller 113 (within the console 112), a handle 114 with a therapy delivery switch 115, a catheter 120 having a central tube 126 with two lithotripsy emitters 122, and a balloon 124. FIG. 6 shows the catheter 120 inserted inside the heart, with the balloon 124 in an inflated state in proximity to a calcified aortic valve 28’ of FIG. 4. As shown in FIG. 5, each emitter 122 represents a pair of arcing electrodes, but alternatively they could comprise optical or laser emitters. The controller 113 can be housed in the same unit as the power source 112 (as shown in FIG. 5). In other embodiments, the power source 112 and controller 113 can be in separate units. Optional marker bands B may be provided to afford visualization and proper positioning by use of known imaging techniques. A catheter sheath 128 is connected at its distal end to a proximal end of the balloon 124. A proximal end of the sheath 128 is connected to a hub 117.

[0030] The balloon 124 can be filled with a conductive medium in order to inflate the balloon 124 and as such, the catheter 120 can be connectable to a source for providing the conductive fluid or medium. The conductive fluid or medium can be supplied to the balloon 124 by a lumen within the catheter sheath 128 for controlling the balloon inflation and desired pressure therein.

[0031] The balloon 124 can be formed of a compliant or semi-complaint balloon material. In some embodiments, the balloon 124 comprises material that is less than 0.0009 inches thick in an unstretched state prior to inflation. The material for the balloon 124 can also be referred to as a “thin-walled balloon material.” One such material comprises a polyamide having repeating units linked by amide links. Some Nylon and PEBAX materials are suitable. Such materials may also include materials such as a composite or multilayer structure. Compliant materials include silicone, polyurethane, or nitinol materials. In some embodiments, thin-walled balloon materials may comprise multi-layer balloon designs and the fluids filling the inner balloon may be dissimilar to the fluid filling the outer balloon to exploit differences in electrical insulative properties, speeds of sound of materials, etc.Compliant, semi-compliant, and non-compliant materials may include nylon, polyurethanes, silicones, polyethylene terephthalate (PET) and other biocompatible materials. In one embodiment, a burst pressure of thin-walled balloons is typically between about 4 and 20 atm, more preferably between 8 and 12 atm. In one example, a Nylon 12 material is used with a rated burst pressure of between about 9 and 12 atm.

[0032] The central tube 126 preferably defines a guide wire lumen 127 through which a guide wire G passes for delivering the balloon 124 at the desired location along the guide wire G. The sheath 128 preferably surrounds the central tube 126 and defines a delivery lumen 129 through which saline can be controllably delivered for balloon inflation. The lumen 129 can provide a concentric space around the central tube 126 within which electrode wires 130 can be run from the switch 115 to the emitters 122. The hub 117 can include any number of ports allowing the electrode wires 130 to pass into the lumen 129 along with saline for inflation, the guide wire G, and any number of other components as desired.

[0033] During insertion into a subject or patient, the balloon 124 may be placed in a deflated position to more readily be advanced through the patient’s vasculature and into the heart and ultimately into the respective heart chamber(s) to arrive in proximity to a region of calcification.

[0034] Once in position with the balloon 124 inflated (as shown in FIG. 6), the lithotripsy emitters 122 may be “fired” to disrupt the calcium lesions. While two electrodepair emitters 122 are shown in FIGs. 5 and 6, in other embodiments the number of electrode pair emitters can comprise only one emitter or more than two emitters (3, 4, 5, 6 or more emitters). The terms “electrode pair” and “emitter” or “electrode pair emitter” are used interchangeably in the present disclosure.

[0035] A high voltage pulse is provided to one of the two emitters 122 and, in accordance with the illustrated embodiment, then in series to the second of the two emitters 122. The high voltage pulse is a minimum voltage of at least 2000 volts and in some embodiments, a voltage of at least 3000 volts. The high voltage pulse causes a spark across the electrodes in the first emitter 122, then or also across the electrodes in the second emitter 122. The somewhat conductive saline solution within the balloon 124 permits the high voltage spark across each electrode pair, thus creating an energy wave that propagates within the balloon 124 toward the calcification 40, resulting in a force that breaks up the calcification 40.

[0036] As described above, the controller 113 of FIG. 5 is used to deliver voltage pulses as described above. The controller 113 can thus regulate delivery of such voltage pulses (high energy acoustic lithotripsy) in terms of pressure and frequency.

[0037] Control by the controller 1 13 can be done including manual manipulation by an operator. Alternatively, some or all of the steps of each operation can be automated. The controller 1 13 can include any number of control modules, such as utilizing electronic switches, or for controlling part or all of sizing and / or high energy acoustic lithotripsy delivery system operation. The controller 113 can also assist in automating the inflation and deflation of the ballon through an internal fluid pump or compressor and pressure gauge, monitored and controlled by programmed electronics. Such a control system can include any number of data processors, memory, and programming provided as software or firmware.

[0038] Although a focus herein is on repair of the calcified aortic valve, the present disclosure and heart valve catheter system is applicable to any of the heart valves. The balloon 124 can be inflated to a typical angioplasty pressure, such as 4 atm, or it may be inflated to a higher pressure, such as, for example, 6 atm, to aid in engaging the heart valve calcifications. In some embodiments, the pressure may range between about 4 and about 6 atm, as additional pressure may be required, as compared to that commonly used for a vessel wall.

[0039] FIG. 7 shows another example of a heart valve catheter system 200 in position inside the heart 10. The heart valve catheter system 200 can be similar in design to the system 100 of FIGs. 5 and 6, and can include a catheter 220, a central tube 226 with emitters 222and marker bands B2, and a balloon 224. FIG. 7 provides a general position of where the catheter 220 would be placed in the heart 10 in order to perform repair of the aortic valve 28. In some embodiments, the system 200 can include an atraumatic tip at the distal end of the catheter 220 for passage through the valve 28 and anchoring of the catheter 220 once in position.

[0040] hi the embodiment of FIG. 7, there are six emitters 222. As provided above, in other embodiments, the catheter 220 can include more or less emitters than the six shown in FIG. 7.

[0041] The system 200 can include catheters 220 in a range of sizes, including a range of sizes for the balloon 224, such that the system 200 can accommodate variability in patient anatomy and / or differences in size of the ventricles / atriums and heart valve annuli. For example, an annulus of the aortic valve 28 may be larger than an annulus of the mitral valve 22. Thus, a catheter designed for repair of the aortic valve 28 may have a bigger balloon than a catheter designed for repair of the mitral valve.

[0042] Given the larger size of the valves 12, 18, 22 and 28 in the heart 10, relative to other vessels in the vascular system, including coronaries and peripheral blood vessels, the balloons for repair of a heart valve may be greater in diameter than blood vessel angioplasty balloons. With larger diameter size balloons, more energy may be needed in order to create a higher energy spark for creating energy waves that propagate to the balloon walls (a comparatively greater distance) and ultimately, the legion or calcification on the heart valve. As such, the high voltage pulse may be greater than the voltages provided above, which include a preferred range of about 2700V and about 3700V. In an example, the high voltage pulse for heart valve repair can be between about 2000V and about 5000V and preferably between 3500V and 4500V. Higher voltages are also contemplated. Moreover, the pressure may be greater than the inflation pressures provided above, which include a range from about 4 atm to about 6 atm. Likewise, the pressure can be lower. It is preferred that the pressure cause a balloon inflation to minimally have the outer balloon surface provide contact with the valve leaflets around the balloon so that one or more high energy acoustic waves are effectively transferred to the valve leaflets to break up a lesion. In an example, the inflation pressure for a balloon for heart valve repair can be between about 2 atm and about 10 atm. The pressure requirement can depend on factors such as the size and type of the balloon, the specific valve being treated, and the patient’s anatomy. This procedure can be guided by imaging techniques like fluoroscopy to ensure proper placement and inflation of the balloon.

[0043] In some embodiments, one or both of the high voltage pulse and the inflation pressure can be greater for a high energy acoustic lithotripsy system than the values used within an intravascular lithotripsy (IVL) system. One or both of the voltage and pressure can be determined based, in part, on a size of the balloon, the size of the particular valve it is to be implanted in, and the size of the lesion or calcification. More specifically, considerations for determining balloon sizing and inflation pressure include the patients valve anatomy and size. Accurate measurement of the valve annulus (the ring-like structure where the valve leaflets attach) is desirable. This can be done using imaging techniques such as echocardiography, computed tomography (CT), or magnetic resonance imaging (MRI). Patient specific consideration can also include the patient’s overall anatomy, including the size and shape of the heart chambers and the presence of any calcifications or other abnormalities. The specific procedure being performed (high energy acoustic lithotripsy procedures with different numbers of emitters, balloon lengths, number of high voltage pulses, and the like can also influence the choice of balloon size. Different procedures may require different balloon diameters and lengths. Additionally, the compliance (flexibility) of the balloon affects how it expands within the valve. Non-compliant balloons expand to a fixed size and are used for precise dilations, while compliant balloons can expand more variably and are used for more flexible applications.

[0044] A method for performing a medical procedure on a subject to modify (i.e. remove or reduce) calcifications on a heart valve of the subject can begin by positioning the high energy acoustic lithotripsy balloon catheter within a calcified heart valve. Then, the bal loon can be then inflated for engaging the external surface of the balloon with the surrounding calcium, and thereby disrupting the calcium. If the operator(s) decides to conduct a further high energy acoustic lithotripsy treatment, the operator can activate one or more, or a series of high voltage pulses to further break up the calcium. Thereafter, the operator(s) can make a determination as to whether there is additional calcium on the heart valve to treat. Such determination can include using fluoroscopy or any available imaging techniques, including echocardiography, CT, MRI, PET and SPECT, to view the heart valve and extent of calcification.

[0045] It should be understood that, depending on the example, certain acts or events of any of the methods described herein can be performed in a different sequence, may be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the method). Moreover, in certain examples, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multipleprocessors, rather than sequentially. In addition, while certain aspects of this disclosure are described as being performed by a single circuit or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or circuits associated with, for example, a medical device.

[0046] In one or more examples, the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium or memory and executed by a hardware-based processing unit or microprocessor. Computer-readable media may include computer-readable storage media or memory, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0047] Thus, instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry'. Accordingly, the term “microprocessor” or “processor,” as used herein may refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0048] The present invention is directed to an ability to provide greater control to the firing of the emitters based upon feedback data of the heartbeat of a subject patient.Preferably, the feedback data will allow for automated control of the actual high voltage pulse and thus the firing of one or more of the emitters. A specific purpose of controlling the emitter firing is to avoid firing the emitters at time where the heart is more vulnerable to altering the heartbeat of the patient.

[0049] During a procedure in accordance with one aspect of the present invention, an electro-cardiogram (ECG or EKG) can be used to monitor the heartbeat of the patient.Specifically, an ECG checks the heart’s rate and rhythm and is typically done during any heart surgery to monitor how well the heart muscle is functioning. This is done by attaching electrodes to the chest, arms and legs of the patient and by connecting such electrodes to an ECG machine by wires. The ECG machine typically includes a display or other graphing device and records and shows the electrical activity of the heart as a graph of voltage versus time.

[0050] As graphed during an ECG and shown in Fig 8, the upper heart chambers (atria) is where your heartbeats start, creating a first wave, called the " P wave.” The P wave is indicated as a positive deviation of the ECG graph. The lower heart chambers (ventricles) create the next wave, called a QRS complex. The next wave, is called the " T wave," which shows your heart at rest or recovering after beating. The QRS complex is representation of a ventricular contraction, known as “systole” and comprises the Q wave, which is a first negative deviation, followed by the R wave, which is a positive deviation. A negative deflection following immediately after the R wave is known as the S wave. The QRS complex represents a depolarization of the ventricles.

[0051] The contraction of the muscles of the heart is referred to as systole, while the relaxation of the heart muscles is referred to as diastole. Systole and diastole are two phases of the cardiac cycle that occur as the heart beats. Systole occurs when the heart contracts, pumping blood out, while diastole takes place when the heart relaxes after contraction. In accordance with preferred aspects of the present invention, it is preferred to avoid high energy acoustic lithotripsy during systole to prevent interference with ventricular contraction and the e jection of blood. Moreover, it is also preferred to avoid high energy acoustic lithotripsy during early diastole so as to prevent disruption of ventricular filling. Thus, it is an aspect of the present invention to deliver high voltage pulses during a mid to late diastole, which is when the ventricles are relaxed and there is minimal movement of the heart valves. The mid to late diastole, or diastolic interval, occurs after the T wave and prior to the next P wave, which period typically lasts approximately for 0.4 - 0.8 seconds at a resting heart rate (typically 60-100 beats per minute). Over the diastolic interval, the heart’s ventricles are relaxing and filling with blood. The diastolic interval may be shorter with a faster heart rate or longer with a slower heart rate.

[0052] Based upon the above considerations for the timing of high voltage pulses to any of the valve leaflets of a patient’s heart, an algorithm for using high energy acoustic lithotripsy for heart valves can be as follows.Algorithm for High Energy Acoustic Lithotripsy in Heart ValvesPatient Assessment

[0053] Indications: Severe calcification in heart valves causing significant stenosis or dysfunction.

[0054] Contraindications: Presence of active infection, severe comorbidities, or contraindications to high energy acoustic lithotripsy.Pre-Procedure Planning

[0055] Imaging: Use echocardiography, CT, or MRI to assess the extent and location of calcification.

[0056] Rhythm Monitoring: Continuous ECG monitoring to detect any arrhythmias during the procedure.

[0057] Hemodynamic Support: Ensure availability of hemodynamic support and pacing capabilities.Procedure TimingAvoid During Specific Cardiac Cycles:

[0058] Systole: Avoid high energy acoustic lithotripsy during systole to prevent interference with ventricular contraction and ejection of blood.

[0059] Early Diastole: Avoid high energy acoustic lithotripsy during early diastole to prevent disruption of ventricular filling.Optimal Timing:

[0060] Mid to Late Diastole: Perform high energy acoustic lithotripsy during mid to late diastole when the ventricles are relaxed, and there is minimal movement of the heart valves.High Energy Acoustic Lithotripsy Delivery

[0061] Energy Settings: Use the lowest effective energy settings to minimize the risk of arrhythmias.

[0062] Pulse Monitoring: Monitor the number and frequency of pulses delivered to avoid excessive mechanical stress on the heart.Intra-Procedure Monitoring

[0063] ECG Monitoring: Continuous ECG monitoring to detect any arrhythmias or conduction disturbances.

[0064] Hemodynamic Monitoring: Continuous monitoring of blood pressure and cardiac output.Post-Procedure Care

[0065] Rhythm Monitoring: Continue ECG monitoring for at least 24 hours postprocedure to detect any delayed arrhythmias.

[0066] Follow-Up Imaging: Perform follow-up imaging to assess the effectiveness of high energy acoustic lithotripsy and check for any complications.Key Considerations

[0067] Avoid high energy acoustic lithotripsy in Patients with Pacemakers / implantable cardioverter defibrillator (ICDs): high energy acoustic lithotripsy may interfere with the sensing capabilities of pacemakers and ICDs.Emergency Preparedness: Be prepared to manage any acute arrhythmias or hemodynamic instability during the procedure.ECG Cycle Specifics

[0068] P-Wave: Represents atrial depolarization.

[0069] Q-Wave: The initial negative deflection produced by ventricular depolarization.

[0070] R-Wave: The first positive deflection produced by ventricular depolarization.

[0071] S -Wave: The negative deflection following the R-wave, completing the QRS complex.

[0072] T-Wave: Represents ventricular repolarization.High Energy Acoustic Lithotripsy and Potentially Sensitive Areas of the Heart, such as the Sinoatrial Node or the AV Node

[0073] Potential Effects: the high energy acoustic lithotripsy can potentially affect the SA node, which is responsible for initiating the heart’s electrical impulses. Disruption of the SA node can lead to arrhythmias. Disruption of the AV node is also to be avoided.

[0074] Timing Considerations: To minimize the risk of affecting the SA node and disturbing the heart’s rhythm, high energy acoustic lithotripsy should be controllably timed:

[0075] Avoid During P-Wave: This is when the atria are depolarizing, and any disruption could affect atrial contraction.

[0076] Avoid During QRS Complex: This is when the ventricles are depolarizing, and interference could lead to ventricular arrhythmias.

[0077] Optimal Timing: Mid to late diastole, when the heart is in a more relaxed state, is generally the preferred period for high energy acoustic lithotripsy.High Energy Acoustic Lithotripsy and Bundle Branch Block (BBB)

[0078] Potential Causes of BBB from high energy acoustic lithotripsy:

[0079] Mechanical Stress: The mechanical stress from high energy acoustic lithotripsy can potentially affect the conduction pathways, particularly if the calcification is near the bundle branches.

[0080] Energy Delivery: The energy from the shock waves used in high energy acoustic lithotripsy could disrupt the electrical conduction system if not controlled, leading to a delay or blockage in the electrical impulses.Specifics on high energy acoustic lithotripsy and BBB:

[0081] Right Bundle Branch Block (RBBB): If high energy acoustic lithotripsy is performed near the right bundle branch, there is a potential of causing RBBB. As such, the positioning of the high energy acoustic lithotripsy balloon and its emitter may be taken into account, with the possibility to move the high energy acoustic lithotripsy balloon or to only selectively fire certain emitters to distance the high energy acoustic lithotripsy effect from the right bundle branch. A system or method of the present invention preferably avoidscontributing to RBBB as it may require further intervention or treatment such as cardiac resynchronization therapy or pacing.

[0082] Left Bundle Branch Block (LBBB): Similarly, if high energy acoustic lithotripsy affects the left bundle branch, it could result in LBBB. As above, the positioning of the high energy acoustic lithotripsy balloon and it’s emitter may be taken into account, with the possibility' to move the high energy' acoustic lithotripsy balloon or to only selectively fire certain emitters to distance the high energy' acoustic lithotripsy effect from the left bundle branch. A system or method of the present invention preferably avoids contributing to LBBB as it may require further intervention or treatment such as cardiac resynchronization therapy or pacing.Timing and Monitoring:

[0083] Avoid During QRS Complex: To minimize the risk of causing BBB. avoid delivering high energy acoustic lithotripsy during the QRS complex.

[0084] Continuous ECG Monitoring: Continuous ECG monitoring is important to detect any immediate signs of BBB during the procedure.

[0085] Fig. 9 is a flowchart of a specific method of use of a high energy acoustic lithotripsy system in accordance with the present invention as may be performed by an interventional cardiologist or other operator. It is a purpose of the present invention to preferably automatically control when the high voltage is delivered, such as based upon the considerations above when monitoring a patient's ECG during a procedure. More specifically, it is preferred to prevent a high voltage pulse and thus prevent the emitters from firing during certain periods of the patient’s heartbeat. The result of which could be to delay a pulse until a desired timing of the heartbeat, such as the mid to late diastole period of the heartbeat. As such, a cardiologist or physician can activate the high energy acoustic lithotripsy system to provide a pulse, or a series of pulses, such as by pressing and / or holding down a button, and such pulse or pulses can be controlled to actually pulse the high voltage and fire the emitters at the desired timing. Also in this regard, the high energy acoustic lithotripsy control system can monitor the heartbeat data during the procedure to closely predict when a next appropriate time will occur, but still make sure that the timing only allows the pulse when the desired timing in the heartbeat occurs.

[0086] An initial step in the method illustrated in Fig. 9 of a high energy acoustic lithotripsy system of the present invention is shown at step 500 and comprises a check as towhether an ECG monitoring system is monitoring the heart of a patient and that the ECG system is operatively connected to the high energy acoustic lithotripsy controller. If it is determined that the ECG is operating and connected with the high energy acoustic lithotripsy controller, the system makes a number of checks regarding the patient for determining whether to proceed. For example, at step 502, the ECG is looked at to see if an arrhythmia is present. Step 504 similarly looks at the ECG to determine if a pacemaker is present. A pacemaker’s presence can in many cases be identified on an ECG by looking for specific characteristics, such as:1. Pacing Spikes: Small, sharp vertical lines (spikes) that appear before the P wave, QRS complex, or both. These spikes represent the electrical impulses generated by the pacemaker.2. Regular Rhythm: Pacemakers often create a very regular heart rhythm, especially if the patient’s natural heart rhythm is irregular.3. Absence of Normal P Waves: In some cases, especially with atrial pacing, the normal P waves may be absent or replaced by paced P waves.4. Wide QRS Complex: If the pacemaker is ventricular, the QRS complexes may appear wider than normal due to the way the electrical impulse spreads through the ventricles.

[0087] At step 506, a check is made as to whether the ECG indicates any conduction block in the heart, such as whether a right branch or left branch bundle block is present. Any number of similar patient-disqualifying checks can similarly be made. If the answer to any of these checks is YES, as indicated at step 508, the method proceeds to step 510, which is a lock-out function that makes the high energy acoustic lithotripsy system inoperative thus preventing the high energy acoustic lithotripsy system from delivering a high voltage pulse.

[0088] If the answer to each of the patient disqualifying checks is NO, as shown as step 512, and if the operator has energized the high energy acoustic lithotripsy system to deliver a high voltage pulse, the method proceeds to step 514 and looks to the ECG in real time to see where the present time is within the patient’s heartbeat. Specifically, the query is whether the ECG is showing the present time an end of the T-wave and before the start of the P-wave. If the answer is YES, as indicated at step 516, the method proceeds to step 518 to allow a high voltage pulse to fire the emitters and apply the generated energy to the calcifiedvalve, as above. If the answer at step 514 is NO, as shown at step 520, the method proceeds to step 522. At step 522, a temporary lock out is done and the ECG is monitored until the end of the T-wave occurs and prior to the start of the P-wave (the mid to late diastole). When that point is reached, the method proceeds to step 518 to allow a high voltage pulse to fire the emitters at that time. In this manner, firing of the emitters and subsequent application of energy to the calcified valve leaflets is controlled to occur specifically at a point of the real time ECG that is deemed the desired point for the high energy acoustic lithotripsy function. Accordingly, a method and system of the present invention can preferably include both a lock out function if the patient has a disqualifying condition and a temporary lock out function to hold the high voltage pulse and emitter firing until the desired. Preferably, the timing for firing is at the mid to late diastole when the heart and its valves are relaxed.

[0089] As utilized within the method just described, the ECG monitoring system is preferably operatively connected with the high energy acoustic lithotripsy system so as to provide feedback of data for allowing a controlled firing of the high energy acoustic lithotripsy system emitters at a desired point based upon a real time ECG. As also noted above, a controller can be provided as part of or independent of the high energy acoustic lithotripsy system that is electronically operatively connected with the ECG system to receive output signals from the ECG system as the feedback of current heartbeat parameters. The controller would preferably include a microprocessor and memory for the microprocessor to use and for storage of software instructions to effectively control the high energy acoustic lithotripsy system operation as described above. Alternatively, specific firmware can be used to control the high energy acoustic lithotripsy operation. If the ECG system is operatively connected with a controller of the high energy acoustic lithotripsy system, data lines can transfer data signals of the real time ECG events directly to the high energy acoustic lithotripsy system. If the controller is provided as a separate unit, such as by a general purpose computer or the like, the computer can include the microprocessor, memory and software instructions with data connectivity similar to the high energy acoustic lithotripsy controller, and with further data connectivity to the high energy acoustic lithotripsy system providing at least a signal to the high energy acoustic lithotripsy system when the real time ECG is at the desired point to fire the high energy acoustic lithotripsy emitters.

[0090] Another aspect of the present invention is a timing of emitter firing based upon whether the particular valve being treated is open or closed. As above, the contractionof the muscles of the heart is referred to as systole, while the relaxation of the heart muscles is referred to as diastole. Systole and diastole are two phases of the cardiac cycle that occur as the heart beats. Systole occurs when the heart contracts, pumping blood out, while diastole takes place when the heart relaxes after contraction.

[0091] Figures 16 and 17 relate to another aspect of the present invention that relates to the use of a steerable, undersized IVL valvuloplasty catheter as described in provisional applications serial numbers 63 / 754,970, filed February 6, 2025, and 63 / 816785, filed June 3,2025, each entitled, “High Acoustic Energy Catheter System for Heart Valve Calcium Modification.”

[0092] Another aspect of the present invention is a timing of emitter firing based upon whether the particular valve being treated is moving toward the closed position or is in the closed position. As above, the contraction of the muscles of the heart is referred to as systole, while the relaxation of the heart muscles is referred to as diastole. Systole and diastole are two phases of the cardiac cycle that occur as the heart beats. Systole occurs when the heart contracts, pumping blood out, while diastole takes place when the heart relaxes after contraction.|0093] Referring back to Fig. 1, blood flow through the heart starts at the right atrium. Blood flows from the right atrium to the right ventricle by way of the tricuspid valve.Similarly, oxygenated blood flows into the left atrium as it returns from the lungs. Blood flows from the left atrium into the left ventricle by way of the mitral valve. Blood flow through the tricuspid and mitral valves is primarily driven by the pressure gradient between the atria and ventricles. During diastole, when the ventricles are relaxed, the pressure in the atria exceeds that in the ventricles, causing the valves to open and allowing passive blood flow. Atrial contraction (atrial systole) contributes to the final 20-30% of ventricular filling, especially important during increased heart rates or in patients w'ith diastolic dysfunction. So, both passive pressure-driven flow and active atrial contraction contribute to ventricular filling. Each of these blood flows occurs during the P wave portion of the ECG indication the filling of both the right and left ventricles. During the QRS portion of the ECG, the heart muscles create ventricular contractions, thereby pushing blood flow from the right ventricle through the pulmonary valve and to the lungs to be oxygenated, and pushing blood flow from the left ventricle through the aortic valve to supply oxygenated blood to the rest of the body.As such, the ventricular contractions occur within systole and as can be tracked as the QRS portion of an ECG wave.

[0094] As to the aortic valve, as a specific example, the aortic valve would be in a closed orientation of the valve leaflets, such as illustrated in Fig. 1, during diastole and as indicated on an ECG as during the T wave through the next P wave. The tricuspid and pulmonary valves would also be closed over this same period. The aortic and pulmonary valves are closed during diastole, which spans from the end of the T wave to the beginning of the next P wave. This closure prevents backflow of blood into the ventricles after systolic ejection. During this time, the ventricles are relaxing and filling, and the AV valves (the mitral and the tricuspid valves) are open, as discussed above.

[0095] This would include the mid to late diastole as discussed above regarding a preferred timing aspect of firing of the IVL emitters. The mitral and tricuspid valves would be closed during the QRS period indicated by an ECG. This prevents backflow into the atria during ventricular contractions. During diastole, the mitral and tricuspid valves are open, as above, allowing the passive blood flow from the atria to the ventricles. Although it is contemplated that an IVL treatment can be done during the QRS period, it would be preferable to do the IVL treatment during diastole so as not to potentially interfere with ventricular contractions or to potentially allow blood backflow through the mitral or tricuspid valve.

[0096] Each of the heart's four valves open and close in coordination with specific phases of the cardiac cycle, which can be tracked using the ECG waveform. The mitral and tricuspid valves open during diastole, after the T wave and before the next P wave, thus allowing blood to flow from the atria into the ventricles. These valves then close at the onset of the QRS complex, marking the beginning of systole, to prevent backflow during ventricular contraction. Conversely, the aortic and pulmonary valves open during systole, following the QRS complex, to allow ejection of blood from the ventricles. They close at the end of the T wave, initiating diastole. This timing ensures unidirectional blood flow and optimal coordination between electrical and mechanical cardiac activity. Aligning high energy acoustic lithotripsy with a desired timing within a heartbeat, such as the mid to late diastole when the heart is relaxed and valve motion is minimal can help minimize the risk of disrupting normal cardiac function.

[0097] As shown in Fig. 16, a catheter 820 can be provided with a deflectable distal tip 580 that can articulate to place the catheter in a desired location within a patient’s heart. Although not shown, it is contemplated that catheter 820 can utilize a guide wire during movement to a desired location (or part of the way to a desired location), after which the guide wire may or may not be removed. In either case, the deflectable distal tip 880 can be used either for large-scale movements or fine tuning of the system 800 within the patient.

[0098] With catheter 820, it is further contemplated that its balloon may be designed to be “undersized” when in its inflated condition relative to the location to which it will be delivered. In an exemplary embodiment, the balloon can be inflatable to a diameter of between 4mm and 6mm for use in the aortic valve, although larger or smaller balloons are contemplated, depending on the size of the valve in which the balloon will be positioned.

[0099] In practice, a size of a calcified heart valve is determined, and then an appropriately sized balloon is guided or steered to a desired location within a subject’s heart to modify (i.e. remove or reduce) calcifications on a heart valve. The balloon can then be inflated so that it does not fill the entire valve space in which it is positioned, such as less than 85 percent or less than 65 percent or less than 60 percent of the area in which it is positioned. Because the undersized balloon can provide relatively low pressure to the leaflets of the valve in which it is positioned, the balloon can continue to be manipulated and repositioned by movement of a distal tip of the catheter even after it is in a generally desired location for treatment of calcification. In addition, when the balloon only partially fills the valve space, it is possible for blood to move past the balloon during the procedure, which is less disruptive to the patient.

[0100] Fig. 16 illustrates the balloon 824 in an inflated state and thus in contact with the leaflets of the aortic valve, for example, so that the leaflets and the balloon 824 close the left ventricle and prevent blood flow from the left atrium back into the left ventricle. During contraction of the left ventricle, blood flow can pass around the undersized balloon 824 into the aorta, as shown in Fig. 17. To be effective for breaking up calcium on the valve leaflets, it is preferable that the leaflets be in contact with the outer surface of the balloon or moving toward a closed position so as to receive the energy wave forces from an IVL treatment. This type of IVL treatment may be more effective for breaking up calcification at the leaflet tips and adjacent tissue as compared with calcification at a leaflets root portion.

[0101] Valves other than the aortic valve can by treated similarly. In each case, the undersized balloon 824 can work with the valve leaflets to close the right and left atriums orthe right ventricle at the times each of the valve is in a closed state and can allow blood flow around the undersized balloon 824 when such flow is initiated.

[0102] Another aspect of the present invention is the controlled selective firing of emitters along the axis of the balloon of a high energy acoustic lithotripsy catheter, such as the high energy acoustic lithotripsy catheter shown in Fig. 7. The balloon 224 is illustrated as it would be positioned within the aortic valve. The balloon 224 can be long enough axially to extend through the aortic valve 28 with portions thereof distal to and proximal to the aortic valve. The illustrated high energy acoustic lithotripsy catheter includes six emitters 222, as an example, where one or more emitter(s) may be positioned distal or proximal to the valve leaflets for a high energy acoustic lithotripsy treatment. As such, it may be desirable to inactivate one or more of the emitters 222, such as those positioned distal to the valve leaflets. Also, it may be desirable to inactivate one or more emitters 222 if they are positioned close to an area of the heart where it is undesirable to generate a high voltage charge and / or to apply pressure and energy. For example, the relatively thick wall between the right and left ventricle includes the right and left bundle branches. It may be undesirable to fire emitters 222 that are in close proximity to this heart wall portion. Similarly, it may be undesirable to fire emitters 22 that are in close proximity to the AV node or the sinoatrial node. In these examples, it may be desirable to selectively inactivate emitters 222 while being able to fire the remaining emitters 222.

[0103] Fig. 10 is a schematic of an electrical circuit 600 allowing for selective firing of emitters 622 using relays K1, K2, K3, K4, K5, and K6 that are preferably provided in the console 612 (shown in dashed lines in Fig. 10). Illustrated is a balloon 624 with three emitters 622. Each one has two contacts with a corresponding wire in the catheter. The console 612 preferably has a capacitor bank 601 that can be charged to a desired high voltage HV, a trigger circuit 602, and the several relays K 1 - K6 that connect the wires (A-F) to either a high voltage rail 603 or a return common ground 604 (the transistor circuit 602 going to ground). The trigger circuit 602 can comprise a transistor 605 provided along a wire 606 running to ground from the common ground 604 for selective firing of the emitters, and the transistor 605 can be operatively connected with a trigger (electrical, mechanical, or otherwise) that is operable by a user of the high energy acoustic lithotripsy catheter system. Wires A, B, C, D, E, and F are schematically noted as connected with the electrode pairs comprising each emitter 622 as basically three circuits in parallel. The electrode pairsproviding the gap for a spark to be generated, as described above. A high voltage circuit is created by wire 607 connectable to the high voltage HV, the high voltage rail 603, the relays K1, K3, and K5 (as in the illustrated embodiment of Fig 10), wires A, C, and E, the emitters 622, wires B, D, and F, relays K2, K4, and K6, the common ground 604, the trigger circuit 602, and the wire to ground 606. As above, the capacitor bank 601 is charged and then can discharge a high voltage pulse under control of the trigger circuit 602 when the trigger circuit 602 closes the high voltage circuit.

[0104] It is noted above that voltage can be increased as one aspect of compensating for a larger diameter balloon. In this regard, the voltage provided as the high voltage pulse is as a result of the capacitor bank 601. So for each pulse generated, the capacitor bank needs sufficient time to fully reenergize for a next firing. If a higher voltage is desired, it will take longer to fully energize the capacitor bank 601. The time to energize the capacitor bank 601 will be a factor in a determination of the frequency of pulses that can be provided. In the present case, where emitter firing is preferably only done at a specific time of and ECG cycle, that timing is also a factor in determining the frequency of pulses.

[0105] As an example of selective connecting of emitters 622 to fire, if prior to triggering a high voltage pulse, relays K1 and K2 are closed connecting wires A and B through the proximal emitter 622, the proximal emitter 622 alone would fire. This same single emitter 622 firing could occur similarly through the middle emitter 622 as connected by wires C and D and by closing relays K3 and K4. Likewise, the distal emitter 622 can connect wires E and F by closing relays K5 and K6. It is also contemplated that any plurality of emitters 622 could be fired at the same time by controlling the appropriate relays between select wire pairs and the emitters, as in the present example, each emitter is fired as a separate parallel electrical circuit. This can be done with any number of emitters connected in parallel, although potentially with more than one high voltage pulse generator, as described below.

[0106] It is also contemplated that one or more additional relays, and wiring can be added to the circuit 600 at a point distal to the relays K1 – K6. For example, a relay K7 can be connected between wires B and C in the console 613, and when the relay K7 is closed along with relays K1 and K4, but with relay K3 open, the proximal and middle emitters 622 would be connected in series. Both the proximal and middle emitters 622 would fire at the same time.

[0107] In another example, connecting distal ends of wires B and C can be done to arrange the proximal and middle emitter in series. Like the parallel circuits described above, you could close relays K1 and K2 to fire emitter 1 only. Likewise, closing relays K3 and K4 will fire the middle emitter 2 alone. However, closing just relays KI and K4 would fire both the proximal and middle emitters in series.

[0108] It is also contemplated that connecting wire ends B to C and B to E and C to E, etc. could be done, for example, in the balloon 624. and then select relays can be closed to fire each emitter by itself, all three together, or certain pairs.

[0109] Other combinations can also be created by adding relays to the console, whereby the high voltage current will travel to an emitter and back and then back out to another emitter, etc. to fire them simultaneously. Other permutations, including the making of additional cross-connections at the distal end, would also be possible and may be preferred.

[0110] With the schematic shown in Fig. 10, based on the use of two-position relays for relays K1 – K7, you can cover all combinations of contiguous emitters. As shown, noncontiguous emitter combinations (e.g. the proximal emitter and the distal emitter) would not both fire because the emitters would be in parallel. In one example, the HV and ground can be connected across the proximal emitter using the first two relays, and HV and ground can be connected across distal emitter using the last two relays. A breakdown of the fluid in a given emitter is a stochastic and non-repeatable process. Each time it takes a slightly different amount of time and the dynamics are slightly different. However, once the plasma channel forms, the voltage across the emitter drops very close to zero. This means that once one emitter (such as the proximal emitter) breaks down, the voltage across a parallel connected emitter (such as the distal emitter) will drop very low, and the parallel connected distal emitter will now fail to break down. In such an example, it would be somewhat random whether the proximal or the distal emitter will fire, depending on other conditions, such as which emitter has a slightly narrower gap, or the like.

[0111] In order to fire non-contiguous emitters, the schematics shown in Figs. 11 and 13 provide circuit arrangement options to do so. In Fig. 11, adding plural "shorting relays" are also provided that can be open or closed. The other relays can be set to various combinations of +HV, GND, or open. According to the schematic of Fig. 1 1, any of the 15 combinations of 4 emitters can be set to fire, and they will fire while being connected inseries. Such a circuit arrangement preferably uses 3-position relays (HV, GND, or open) in all or most of the relays K1 – K5 along with single pole, single throw (just open / closed) shorting relays S1 and S2.

[0112] Another example circuit is schematically illustrated in Fig. 13. In this circuit, two independent high-voltage sources are provided. This circuit uses three-position relays for K2 and K4 and two-position relays for KI and K5. The K3 relay is eliminated; that node can just be connected to the switched ground for all cases. Having two separate HV sources has the disadvantages of greater cost and complexity and size, but has the advantage of not needing to be adjustable over such a wide range. To fire four emitters in series would require higher voltage than to fire two. But according to this example circuit, only one or two (or zero) emitters are fired from a given capacitor bank. This arrangement also has an advantage over the "shorting relay" arrangement of Fig. 11 because the spark current only goes proximal to distal and back. In the shorting arrangement of Fig. 11, with a shorting relay closed, current makes two round trips (out, back through one or both shorting relays, and out and back again).

[0113] Figs. 12, and 14 show how any combination of emitters El - E4 can be fired by controlling the position of the relays KI - K5, respectively for the Figs. 11 and 13 circuit versions, along with the shorting relays SI and S2 for the shorting relay circuit and the plural high voltage circuits HV1 and HV2 for the plural high voltage supply circuit.

[0114] According to a further aspect of the present invention, a graphical user interface (GUI) 700 is shown in Fig. 15 that can be used to control a five-emitter high energy acoustic lithotripsy system 702, as such can be used in any valvular location within a heart 704. The GUI 500 can include an indicator light, such as an LED, for each emitter of the high energy acoustic lithotripsy system. Preferably, an indicator light would be provided for each emitter. Each indicator light can include a designation identifier for one of the emitters. A cardiologist or other physician can select specifically each emitter that is desired to be fired as such GUI 700 is operatively electrically connected with a control circuit, such as those described above and shown in Figs. 10, 11, and 13. As above, the selection of which emitters to be fired can be based on the position of the high energy acoustic lithotripsy balloon within a valvular location within the heart 704, which specific location can be determined by any of the imaging techniques discussed above as known or developed. The GUI can comprise atouchscreen, or independent buttons, switches, or the like. Different colors can indicate whether a particular emitter is “on” so as to be fired at a next high voltage pulse or “off".

[0115] Other aspects of high energy acoustic lithotripsy systems of the present invention and other related features thereof are described in U.S. provisional application number 63 / 754,970 titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION” that was filed on February 6, 2025. U.S., provisional application number 63 / 816,785 titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION”, that was filed on June 3, 2025, provisional application number 63 / 904,986 titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION”, that was filed on October 24. 2025, and U.S. provisional application number 63 / 754,811 titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION”, that was filed on February 6, 2025. Each of which provisional applications are fully incorporated herein in their entirety by reference.

[0116] The description of the invention and its applications as set forth herein is illustrative and is not intended to limit the scope of the invention. Features of various embodiments may be combined with other embodiments within the contemplation of this invention. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives to and equivalents of the various elements of the embodiments would be understood to those of ordinary skill in the art upon study of this patent document. These and other variations and modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the invention.

Claims

ClaimsWhat is claimed is:

1. A heart valve catheter for repairing a calcified heart valve of a subject, the catheter comprising:an inflatable balloon at a distal portion of the catheter, the inflatable balloon connectable at a proximal portion of the catheter to a source for providing a conductive medium inside the balloon;first and second electrodes located inside the balloon to form a first emitter, the first and second electrodes connectable at the proximal portion of the catheter to a high voltage pulse generator to generate a high voltage pulse, thereby creating a spark across the first emitter through the conductive medium to perform a first high energy acoustic lithotripsy operation on calcification lesions of the calcified heart valve;a controller in operative connection with the high voltage pulse generator and for operative connection with an electrocardiogram (ECG) system for receiving real time data of a patient’s heartbeat cycle, the controller including a microprocessor, memory, and programmed instructions to monitor the heartbeat cycles and to only allow the generation of a high voltage pulse at a predetermined time of the heartbeat cycle.

2. The heart valve catheter of claim 1, wherein the predetermined time of the heartbeat cycle is a time period as indicated by the ECG system within the mid to late diastole of the heartbeat cycles.

3. The heart valve catheter of claim 2, wherein an initial lock out of the generation of a high voltage pulse is determined by the programmed instructions if the ECG indicates at least one of a heart arrhythmia, the presence of a pacemaker or ICD within the patient’s heart, and a conduction block, so that the emitters cannot be fired.

4. The heart valve catheter of claim 3, wherein the programmed instructions for controlling the generation of a high voltage pulse at a predetermined time of the heartbeatcycle provides a temporary lock out of the emitter from being fired until the predetermined time of the heartbeat cycle occurs.

5. A heart valve catheter system for repairing a calcified heart valve of a subject, the catheter system comprising:an inflatable balloon at a distal portion of the catheter, the inflatable balloon connectable at a proximal portion of the catheter to a source for providing a conductive medium inside the balloon;first and second electrodes located inside the balloon to form a first emitter, the first and second electrodes connectable at the proximal portion of the catheter to a high voltage pulse generator to generate a high voltage pulse, thereby creating a spark across the first emitter through the conductive medium to perform a first high energy acoustic lithotripsy operation on calcification lesions of the calcified heart valve;a trigger circuit for selective opening or closing of a high voltage circuit;an electrocardiogram (ECG) system for receiving real time data of a patient’s heartbeat cycles; anda controller in operative connection with and for controlling the high voltage pulse generator and in operative connection with the ECG system, the controller including a microprocessor, memory, and programmed instructions to monitor the heartbeat cycle and to only allow the generation of a high voltage pulse at a predetermined time of at least one heartbeat cycle.

6. The heart valve catheter system of claim 5, wherein the predetermined time of the heartbeat cycle is a time period as indicated by the ECG system within the mid to late diastole of the one or more of the heartbeat cycle.

7. The heart valve catheter system of claim 6, wherein an initial lock out of the generation of a high voltage pulse is determined by the programmed instructions if the ECG indicates at least one of a heart arrhythmia, the presence of a pacemaker or ICD within the patient’s heart, and a conduction block, so that the emitters cannot be fired.

8. The heart valve catheter system of claim 7, wherein the programmed instructions for controlling the generation of a high voltage pulse at a predetermined time of the heartbeat cycles provides a temporary lock out of the emitter from being fired until the predetermined time of the heartbeat cycle occurs.

9. A method of treatment of a heart valve with a calcified heart valve catheter system for repairing the calcified heart valve of a subject, the catheter system comprising:inserting an inflatable balloon of the catheter system within a patient’s heart at the location of the calcified heart valve leaflet, the inflatable balloon provided at a distal portion of the catheter and including first and second electrodes located inside the balloon to form a first emitter, the first and second electrodes connected at the proximal portion of the catheter to a high voltage pulse generator to generate a high voltage pulse;connecting an electrocardiogram (ECG) system to the patient for receiving real time data of a patient’s heartbeat cycle;inflating the balloon to an expanded state in contact with at least one leaflet of the calcified heat valve from a conductive medium source provided at the proximal portion of the catheter;activating a trigger circuit for closing a high voltage circuit and generating the high voltage pulse thereby creating a spark across the first emitter through the conductive medium to perform a high energy acoustic lithotripsy operation on calcification lesions of the at least one calcified heart valve leaflet under control of a controller in operative connection with and for controlling the high voltage pulse generator and in operative connection w'ith the ECG system, the controller including a microprocessor, memory, and programmed instructions; monitoring the heartbeat cycle by the ECG system to only allow the generation of a high voltage pulse at a predetermined point of one or more of the heartbeat cycle.

10. The method of claim 9, further comprising the generation of a high voltage pulse and thus a spark at the at least one emitter after determining that the timing of the generation of the high voltage pulse is at the predetermined time of at least one of the heartbeat cycle indicated by the ECG system within the mid to late diastole of the one or more of the heartbeat cycle.

11. The method of claim 9, further comprising determining from the ECG that at least one of a heart arrhythmia, the presence of a pacemaker or ICD within the patient’s heart, and a conduction block, and locking out the generating of a high voltage pulse so that the emitters cannot be fired.

12. The method of claim 9, further comprising determining from the ECG that a heartbeat cycle is not at the predetermined point when the trigger is activated, and thus temporarily locking out the generating of a high voltage pulse, and delaying the generating of the high voltage pulse and firing the at least one emitter when the predetermined point of the at least one heartbeat cycle occurs.

13. The method of claim 9, wherein the step of activating the trigger is done by the controller based upon an automated determination of performing the high energy acoustic lithotripsy operation.

14. The heart valve catheter system of claim 5, wherein the controller is operatively connected with a plurality of relays for selectively connecting any number of emitters with the high voltage pulse generator and for selectively disconnected any one of more of the emitters from the high voltage pulse generator.

15. The method of claim 9, further comprising the generation of a high voltage pulse and thus a spark at the at least one emitter after determining that the timing of the generation of the high voltage pulse is at the predetermined time of at least one of the heartbeat cycle indicated by the ECG system of when a select heart valve is in a closed state or moving toward a closed state.

16. The heart valve catheter of claim 1, wherein the predetermined time of the heartbeat cycle is a time period as indicated by the ECG system of when a select heart valve is in a closed state or moving toward a closed state.

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