High acoustic energy catheter system for heart valve calcium modification

Abstract

A system and method for modifying calcifications on a heart valve includes a catheter for providing high energy acoustic waves. The catheter includes a tip portion located distal to an inflatable balloon and the tip portion can include an atraumatic flexible tip for anchoring the catheter and / or deterring movement of the catheter when the catheter is temporarily placed inside a chamber of the heart. The atraumatic flexible tip includes a curved shape at a distal end portion of the tip. A shape and length of the atraumatic flexible tip can be adjusted to accommodate different sized hearts and ventricles within the heart and / or to sufficiently anchor the catheter.

Description

CSI0052WO (16037WOO2)HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATIONCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 754,811, filed February 6, 2025, and entitled HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION, the entire contents of which is incorporated herein by reference in its entirety.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 three leaflets (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.SUMMARY

[0008] A heart valve catheter can be used for providing high energy acoustic waves to a heart valve region of a subject. The heart valve catheter can include an inflatable balloon at a distal portion of the catheter, the inflatable balloon adapted to receive fluid to move the balloon from a radial extended position for providing therapy to a radial retracted position for traversing a vessel of a subject. The heart valve catheter can also include first and second electrodes within the inflatable balloon to form a first emitter and spaced axially along a longitudinal axis of the catheter, a conductive pathway for supplying energy to the first and second electrodes to produce a spark between the electrodes to generate high energy acoustic waves within the fluid inflating the balloon, and a tip portion located distal to the inflatable balloon. The tip portion can include an atraumatic flexible tip for deterring movement of the catheter when the catheter is temporarily placed inside a chamber of the heart, the atraumatic flexible tip having a curved shape at a distal portion of the atraumatic flexible tip.

[0009] A system for performing high energy acoustic lithotripsy of a calcified heart valve of a subject can include a high voltage pulse generator and a catheter having a distal portion provided with an inflatable ballon, the inflatable balloon connectable to a source for providing a conductive medium to inflate the balloon. First and second electrodes of thesystem can be located inside the balloon to form a first emitter, the first and second electrodes electrically connected to the high voltage pulse generator such that when a high voltage pulse is generated, a spark is created across the first emitter through the conductive medium to perform high energy acoustic lithotripsy treatment of calcified lesions of the calcified heart valve to break up and / or remove calcifications from the heart valve region. A curved tip on a distal portion of the catheter can temporarily anchor the catheter in position for performing the high energy acoustic lithotripsy treatment.

[0010] A method of performing a medical procedure on a subject to modify calcifications on a heart valve can use a catheter having an inflatable balloon and an atraumatic tip on a distal end of the catheter. The method can include inserting the inflatable balloon into a chamber of a heart of the subject in proximity to a heart valve, the inflatable balloon comprising a conductive medium inside the balloon, and using the atraumatic tip to position the catheter inside the chamber and limit or prevent movement of the catheter in an axial direction, the atraumatic tip having a curved portion. The method can also include inflating the balloon such that an exterior surface of the balloon is in contact with one or more leaflets of the heart valve to break up calcifications on the one or more leaflets, and providing a high voltage pulse from a high voltage pulse generator to create a spark from an emitter for creating an energy wave for propagation through the fluid within the balloon to provide force from the balloon to break up the calcifications.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] These drawings are exemplary illustrations of certain embodiments and, as such, are not intended to limit the disclosure.

[0012] FIG. 1 is a schematic of a heart showing the chambers, valves and direction of blood flow.

[0013] FIG. 2 is a top view schematic of the heart of FIG. 1 showing the four heart valves.

[0014] FIG. 3 is a schematic of the left side of the heart of FIG. 1 showing the aortic valve in an open position.

[0015] FIG. 4 is a schematic of the left side of the heart showing a calcified aortic valve in an open position.

[0016] FIG. 5 illustrates a heart valve catheter system for performing high energy acoustic lithotripsy of a heart valve region of a patient, according to one or more embodiments of the present disclosure.

[0017] 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.

[0018] FIG. 7 illustrates another example of a heart valve catheter system inserted inside the heart for performing high energy acoustic lithotripsy of a heart valve region, according to one or more embodiments of the present disclosure.

[0019] FIG. 8 is a schematic of the catheter of the heart valve catheter system of FIG. 7, which includes an atraumatic tip, according to one or more embodiments of the present disclosure.

[0020] FIG. 9A is a perspective view of the atraumatic tip of FIG. 8, according to one or more embodiments of the present disclosure.

[0021] FIG. 9B is a side view of the atraumatic tip of FIG. 9A.

[0022] FIG. 9C is side view of the atraumatic tip of FIGS. 9A and 9B after the tip is cut to length but before it is assembled to have a curved portion.

[0023] FIG. 10 illustrates another example of a heart valve catheter system for performing high energy acoustic lithotripsy of a calcified heart valve, according to one or more embodiments of the present disclosure.

[0024] FIG. 11 is an end view of another example of an atraumatic tip for use in a heart valve catheter system, according to one or more embodiments of the present disclosure.

[0025] FIG. 12A is a perspective view of the atraumatic tip of FIG. 11 with a push-pull wire inserted into the atraumatic tip, according to one or more embodiments of the present disclosure.

[0026] FIG. 12B is a perspective view of the atraumatic tip and the push-pull wire of FIG. 12A with the atraumatic tip in an extended position, according to one or more embodiments of the present disclosure.

[0027] FIG. 12C is a perspective view of the atraumatic tip and the push-pull wire of FIG. 12A with the atraumatic tip in a coiled position, according to one or more embodiments of the present disclosure.

[0028] FIG. 13 illustrates another example of a heart valve catheter system for performing high energy acoustic lithotripsy of a calcified heart valve, according to one or more embodiments of the present disclosure.DETAILED DESCRIPTION

[0029] The present disclosure is directed to a catheter system for treating a calcified heart valve. More specifically, the present disclosure is directed to a heart valve catheter system that includes an atraumatic tip at a distal end of the catheter, the atraumatic tip having a curved portion which can be flexible and / or deformable. During placement of the catheter in a chamber of the heart, it can be important to avoid injury to the valve and / or avoid piercing the ventricle wall. The atraumatic tip is designed to aid in proper placement of the catheter, without injury, and can additionally be used to anchor the catheter once at the desired location within the heart.

[0030] The heart valve catheter system includes an inflatable balloon that can be inflated with a conductive medium, such as saline, and one or more emitters, 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.

[0031] The high energy acoustic lithotripsy of a heart valve region catheter system described herein can be used as a less invasive alternative to valve replacement. 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 patient for a subsequent transcatheter heart valve replacement procedure. The use of the present invention is believed to reduce the chances of paravalvular leakage after a transcatheter heart valve replacement procedure.

[0032] 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 positionedwithin 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 (IVL) devices can be provided in different designs and sizes, and utilize a reusable power source such as an IVL 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 entire contents of which are hereby incorporated by reference. The present invention is preferably compatible with or used with an energy source or generator (e.g. a 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. Reference is made to U.S. Provisional Application Serial No. 63 / 754,798 filed on February 6, 2025 and titled “SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLE” and U.S. Provisional Application Serial No.63 / 856,958 filed on August 4, 2025 and titled “SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLE”, which disclose methods and systems for timing and selective firing of emitters.

[0033] The present disclosure focuses on using high energy acoustic lithotripsy of a heart valve region 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.

[0034] FIG. 5 shows a heart valve catheter system 100 for performing high energy acoustic lithotripsy of a heart valve region 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.

[0035] 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.

[0036] 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 20atm, 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.

[0037] 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.

[0038] 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.

[0039] 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 electrode pair 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.

[0040] 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.

[0041] 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 in terms of pressure and frequency.

[0042] Control by the controller 113 can be done including manual manipulation by an operator. Alternatively, some or all of the steps of each operation can be automated. Thecontroller 113 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 system operation. The controller 113 can also assist in automating the inflation and deflation of the balloon 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.

[0043] 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.

[0044] 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 222 and 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. (The atraumatic tip is described further below in reference to FIGs. 8-10.)

[0045] In the embodiment of FIG. 7, there are six emitters 222. As provided above, in other embodiments, the catheter 220 can include more or fewer emitters than the six shown in FIG. 7.

[0046] 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.

[0047] 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 ahigher 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.

[0048] 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.

[0049] 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 balloon catheter within a calcified heart valve. Then, the balloon can be then inflated, engaging the externally surface of the balloon with the surrounding calcium, 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 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.

[0050] 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 necessaiy 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 multiple processors, 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.

[0051] 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).

[0052] 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 gate 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.

[0053] FIG. 8 is a schematic of the catheter 200 of FIG. 7. The catheter 200 includes an atraumatic tip 230 that can be integral with or removably attached to a distal portion of the central tube 226. The atraumatic tip 230 can also be referred to herein as a flexible tip or a deformable tip. The atraumatic tip 230 can include a curved portion 232 and a straight portion 234. In some embodiments, the curved portion 232 is generally circular and / or the tip 230 has a pig tail shape. It is recognized that other shapes that are curved (and do not have sharp ends) can be used as alternatives to the pig tail shape of FIG. 8.

[0054] Referring back to FIG. 7, the catheter device 200 can be sized such that when the atraumatic tip 230 makes contact with the ventricle wall (as shown in FIG. 7), the catheter 220 is positioned properly in the heart, meaning the balloon 224 is in proximity to or touching the leaflets that form the aortic valve. Once the catheter 220 is in the proper position, the atraumatic tip 230, which is generally fixed against the ventricle well, can function as an anchoring mechanism to anchor the balloon 224 in the valve annulus of the aortic valve and prevent or deter the balloon 224 (and the catheter 220) from moving, particularly in an axial direction. As described further below, at least a portion of the tip 230 can be formed of a deformable material. When the tip 230 makes contact with the ventricle wall, the tip 230 deforms or bends and spreads the resulting force over a larger surface area, as compared to a tip with a sharp end and / or a stiff material without any deformability.

[0055] In some embodiments, the atraumatic tip 230 is removably attached to the catheter tube 226 and thus the tip 230 can be separable from the rest of the catheter system 200. A proximal end 238 of the tip 230 can be removably connected to a distal end of the catheter 220. In such a design, the tip 230 can be replaceable as needed, and different size tips can be used interchangeably with the catheter 220.

[0056] In some embodiments, the atraumatic tip is integral with the catheter 220, specifically with the catheter tube 226. In some embodiments, the atraumatic tip 230 can be bonded or otherwise attached at the proximal end 238 to a distal end of the catheter tube 226. In some embodiments, a portion or all of the atraumatic tip 230 can be formed of the same material as the catheter tube 226. In some embodiments, the atraumatic tip 230 can be formed of a different material than the catheter tube 226 and / or formed of more than one material at different portions of the tip 230.

[0057] In some embodiments, the atraumatic tip 230 can be generally hollow and can include a central passageway (described below) that can align with the guide wire lumen defined by the central tube 226 of the catheter 220. In some embodiments, the atraumatic tip 230 can include a second passageway 236 located on a side of the tip 230 that permits someamount of blood flow into the tip 230 (via the central passageway) and into the lumen of the central tube 226 of the catheter 200. The passageway 236 can also be referred to herein as a bypass line 236.

[0058] FIG. 9A is a perspective view of the atraumatic tip 230; FIG. 9B is a side view of the atraumatic tip 230 rotated about 90 degrees counter-clockwise relative to FIG.9A; and FIG. 9C shows a total length of the atraumatic tip 230 in an unassembled position (i.e. before the tip is assembled into the pig tail shape). The curved portion 232 and the straight portion 234 are clear from FIGs. 9A and 9B, and a transition point 233 (or a transition region / portion 233) can generally indicate where the tip 230 changes from the curved portion 232 to the straight portion 234. The tip 230 includes the proximal end 238 (also referred to as a first end 238) and a second end 240. A central passageway P can extend through at least a portion of the tip 230 starting at the proximal end 238.

[0059] In some embodiments, a design of the tip 230 can include a cap that can be placed over the second end 240 such that the tip 230 has a closed distal end. Such a cap can be used to prevent blood flow backwards into the tip 230 and ultimately into the catheter 220. If the tip 230 is used with a guide wire (see FIG. 10), the tip 230 is hollow.

[0060] As seen by FIG. 9B, the curved portion 232 can be generally circular shaped. A size of the curved portion 232 can be defined by a diameter D. In some embodiments, the diameter D is between about 1 and about 7 centimeters (cm). In some embodiments, the diameter is between about 2 and about 4 cm. It is recognized that the diameter D can be larger or smaller than the ranges and values provided herein. The diameter D can depend, in part, on how flexible the curved portion 232 is and / or what valve the catheter 220 is intended for repair of.

[0061] In some embodiments, the circular shape is not a closed circle; rather, there is a gap or space 242 between the second end 240 and the straight portion 233 such that the second end 240 can curl inward (towards a center of the circle defined by the curved portion 232) as the curved portion 232 deforms more when a force is applied to the curved portion 232. The curved portion 232 and a small part of the straight portion 234 (starting in proximity to the gap / space 242 and to the transition point 233) can be defined as a distal portion of the tip 230 and can be opposite a proximal portion of the tip 230, which includes the first / proximal end 238.

[0062] A length LI of the tip 230 in an assembled position with the pig tail shape (see FIG. 9B) can be defined as a distance between the first / proximal end 238 and a distal-most end 244 of the tip 230. The distal-most end 244 can also be referred to herein as a distal-mostportion 244 of the tip 230. In some embodiments, the length LI is between about 2 and about 9 cm. In some embodiments, the length LI is between about 3 and about 6 cm.

[0063] An overall length L2 of the tip 230 in an unassembled, linear position (see FIG. 9C) can be defined as a distance between the first / proximal end 238 and the second end 240. Clearly the length L2 is greater than the length LI. In some embodiments, the length L2 is between about 4 and about 24 cm. In some embodiments, the length L2 is between about 7 and about 15 cm.

[0064] In some embodiments, the passageway P is configured such that a guide wire can be passed through the tip 230. In some embodiments, a diameter of the passageway P is between about 0.014” and about 0.040”. A wall thickness WT of the tip 230 can be based in part on the material used to form the tip 130, the desired material properties and desired performance of the tip 230, as well as the size and properties of the catheter 220. In some embodiments, the wall thickness WT is between about 0.001” and about 0.10”.

[0065] It is recognized that the size ranges provided herein for the tip 230 can vary depending, for example, on catheter sizing, balloon sizing and guidewire sizing, including a diameter and a length of each of these components of the system. Thus, the dimensions provided herein for the tip 230 can be larger or smaller depending in part on the other components and the design of the system overall.

[0066] The tip 230 can be formed or one or more materials that are deformable or flexible. In some embodiments, the tip 230 is formed of materials that can undergo elastic or plastic deformation. Such materials can include, for example, polymers (including plastics) and elastics (including elastic metals). In some embodiments, the tip 230 can be formed of at least one of nylon, polyether block amide, polyurethane elastomer, HDPE, LDPE, or similar materials.

[0067] In some embodiments, different parts of the tip 230 can be formed of different materials. In some embodiments, the tip 230 can be formed of one material but a property of the material (for example, stiffness) can vary on the tip 230. In some embodiments, all or a portion of the tip 230 can include reinforcements, such as braids or coils with various patterns to achieve a desired stiffness or flexibility.

[0068] In some embodiments, the stiffness can vary along the length L2 of the tip 230. In an example, the tip 230 can become less stiff from the proximal end 238 to the second end 240. In some embodiments, the straight portion 234 can be stiffer than the curved portion 232. In some embodiments, the stiffness can be generally uniform along the length L2 of the tip 230.

[0069] FIG. 10 is a schematic of another example of a heart valve catheter system 300 for use in performing a high energy acoustic lithotripsy operation. The heart valve catheter system 300 can be similar to the heart valve catheter system 200 of FIGS. 7 and 8, and can include a catheter 320 that has an atraumatic tip 330 that is generally similar to the atraumatic tip 230. The catheter 320 can include a guide wire G2 that is configured to pass through a central tube 326 and through the atraumatic tip 330. The guide wire G2 can exit the atraumatic tip 330 via a second end 340. The guide wire G2 can be used in positioning of the catheter 320 inside the heart and then can be retracted. The atraumatic tip 300 can help anchor the catheter 320 in position as described above.

[0070] FIGs. 11 and 12A-12C illustrate another example of an atraumatic tip 430 configured for use in a heart valve catheter system. FIG. 11 shows a proximal end of the atraumatic tip 430. The tip 430 includes a central lumen 450 (for receiving a guide wire like the guide wire G2 of FIG. 10) and a side slot 452 (or side passageway 452), both of which can extend from a proximal end of the atraumatic tip 430 towards a distal end of the tip 430. The side slot 452 can receive a push-pull wire 454 (see FIGs. 12A-12C) that is designed for changing a shape or configuration of the curved portion of the tip 430. Because the side slot 452 is offset from a center of the passageway through the tip 430, the push-pull wire 454 can be used in combination with and / or independent of a guide wire that is received through the central lumen 450.

[0071] FIG. 12A shows the tip 430 in a relaxed position. The tip 430 can be similar in design to the tips 230 and 330 and can include a straight portion and a curved portion, the curved portion generally having a pig tail shape. In the relaxed state, the tip 430 can have a length T3, as measured from a proximal end 456 of the tip 430 to a distal most point on the tip 430. It is noted that the distal most point on the tip 430 may not be the same as the transition point on the tip 430 (where the straight portion changes into the curved portion of the tip 430). As shown in FIG. 12A, the push-pull wire 454 (or pull wire 454) extends into the proximal end 456 of the tip 430 and through the straight portion of the tip 430. Although not shown in FIG. 12A, the pull wire 454 can extend from a central tube of the catheter (see for example, the central tube 226 of FIG. 8).

[0072] FIG. 12B shows the tip 430 in an extended position in which the curved portion of the tip 430 has partially straightened out or uncoiled from the pig tail position of FIG. 12A. When the push-pull wire 454 is extended further or advanced into the curved portion of the tip 430 (as compared to its position in FIG. 12 A), the pull wire 454 can cause the tip 430 to straighten out or uncoil at a region of the tip 430 in proximity to the transitionpoint and / or the curved portion of the tip 430. As a result of this uncoiling or straightening, a length L4 of the tip 430 (measured from the proximal end 456 of the tip 430 to a distal most point on the tip 430) can be greater than the length L3 of the tip 430 in the relaxed position.

[0073] FIG. 12C shows the tip 430 in a coiled or compact position in which a second end 440 of the tip 430 (opposite to the proximal end 456) curls inward to form a more compact circular shape or a tighter curl. The coiled position of FIG. 12C can be achieved by retracting the pull wire 454 from the passageway 452 such that the pull wire 454 no longer extends into the curved portion of the tip 430. This coiling of the curved portion of the tip 430 results in a reduced length of the tip 430 such that a length L5 is less than the length L3 in the relaxed position (and less than the length L4). The length L5 is measured from the proximal end 456 to the distal most point on the tip 430.

[0074] Note that the distal most point on the tip 430 changes as a result of the change in shape and this leads to the change in a length of the tip as measured from the proximal end 456 to the distal most point on the tip 430. An overall length of the tip 430 (see L2 of FIG.9C) as measured from the proximal end 456 to the second end 440 does not change as the shape of the curved portion changes.

[0075] The slot 452 and pull wire 454 can be used to change where on the tip 430 the curved shape starts and the extent of the curl of the curved portion, thereby lengthening or shortening the tip 430. This is an example of how the shape of the tip 430 can be changed, but it is recognized that different features or methods can be used for changing the shape of the tip 430. In other examples, the natural or relaxed state of the tip 430 can be different than that shown in FIG. 12A - the relaxed state could be more curled or less curled, relative to the shape in FIG. 12A. The particular stiffness of the material used in forming an atraumatic tip can be selected based, for example, on the relaxed state and the particular shape the tip forms (or returns to via shape memory) in the relaxed state.

[0076] The adjustable or deformable shape of the distal portion of the tip 430 allows the specific shape to be optimized or fine-tuned during the procedure so that the tip 430 sufficiently engages with the ventricle to temporarily hold or lock the catheter in place. The adjustable or deformable shape of the tip 430 also results in lengthening or shortening of the tip 430 overall and can be done during placement of the heart valve catheter system in the appropriate ventricle, thus allowing the catheter to be adjusted to the size (length) needed for a particular subject.

[0077] Even though FIG. 7 shows the heart valve catheter system 200 removably implanted in the aortic valve, the heart valve catheter systems described herein can be used inany of the other heart valves in addition to the aortic valve. The overall size of the catheter selected for use in a particular subject can depend on at least the size of the subject, the size of the subject’s heart and corresponding ventricles, and the particular heart valve to be repaired. A variety of catheter sizes can be provided, including a variety of balloon sizes, and a variety of atraumatic tips can be provided for use with the different catheters. The variety of atraumatic tips can include tips having differing lengths (for example, differing lengths LI and / or L2 - see FIGs. 9B and 9C), differing shapes or dimensions for the curved portion of the tip, and differing material properties of the tip.

[0078] Each atraumatic tip can be designed for use over an acceptable range of subjects (based on at least one of overall patient size, heart size or ventricle size) for repair of one or more valves. For example, patient anatomical data and / or empirical data can be used to determine a typical distance from the annulus of a specific valve to the apex or wall of a specific ventricle. This data can be used to determine which catheter size and which atraumatic tip is best suited for a particular valve repair for a particular patient. By providing various atraumatic tip sizes and designs, the heart valve catheter systems described herein can be semi-customizable.

[0079] The atraumatic tips 230, 330 and 430 include pig tail shapes for the curved portion 232. In other embodiments, a curved portion of the atraumatic tip can have an alternative shape (with some curvature) that allows anchoring of the catheter, without risk of perforating anatomy of the patient.

[0080] The atraumatic tips 230, 330 and 430 can be used in combination with a deflectable tip, such as is disclosed in another provisional application, U.S. Application Serial No. 63 / 754,970 filed on February 6, 2025 and titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION”. Such deflectable tip is shown here in FIG. 13 in combination with an atraumatic tip that can be similar to the tips 230, 330 and 430 described above. FIG. 13 shows a heart valve catheter system 500 that is similar in design to those described above and can include a catheter 520, a central tube with emitters, and a balloon. As shown in FIG. 13, the catheter system 500 includes an atraumatic tip 530 which can extend or be connected to a distal portion of the catheter 520.

[0081] The catheter 520 can include a deflectable distal tip 580 (or deflectable distal portion 580) that can articulate such that a guide wire is not needed to place the catheter 520 in a desired location within a patient’s heart. The deflectable distal portion 580 can be used either for large-scale movements or fine tuning of the system 500 within the patient. One ormore push / pull wires 560 can be used in combination with at least one push / pull ring 564 to control movement of the deflectable tip 580. The atraumatic tip 530 can extend from or be connected to the distal tip 580.

[0082] The atraumatic tips 230, 330, 430 and 530 can include a radiopaque material in the tip 230 / 330. The atraumatic tips 230, 330, 430 and 530 can be used with existing marker bands on the catheters (see the bands B2 in FIG. 7). In addition to or as an alternative, the tips 230, 330, 430 and 530 can use other known imaging techniques for visualization and tracking of the tip 230 / 330 / 430 / 530 during placement in the heart and proper anatomical positioning.

[0083] Other aspects of high energy acoustic lithotripsy systems of the present invention and other related features thereof are described in U.S. Provisional Application Serial No. 63 / 754,970 filed on February 6, 2025 and titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION”, Application Serial No. 63 / 754,798 filed on February 6, 2025 and titled “SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLE”, Application Serial No. 63 / 816,785 filed on June 3, 2025 and titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION”, Application Serial No. 63 / 856,958 filed on August 4, 2025 and titled “SYSTEMS AND METHODS FOR CONTROLLED DELIVERY OF ENERGY BY A CATHETER SYSTEM BASED ON A HEARTBEAT CYCLE”, and Application Serial No. 63 / 904,986 filed on October 24, 2025 and titled “HIGH ACOUSTIC ENERGY CATHETER SYSTEM FOR HEART VALVE CALCIUM MODIFICATION”. The disclosures of each of these provisional applications are fully incorporated herein in their entirety by reference.

[0084] 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

CLAIMS:

1. A heart valve catheter for providing high energy acoustic waves to a heart valve region of a subject, the catheter comprising:an inflatable balloon at a distal portion of the catheter, the inflatable balloon adapted to receive fluid to move the balloon from a radial extended position for providing therapy to a radial retracted position for traversing a vessel of a subject;first and second electrodes within the inflatable balloon to form a first emitter and spaced axially along a longitudinal axis of the catheter;a conductive pathway for supplying energy to the first and second electrodes to produce a spark between the electrodes to generate high energy acoustic waves within the fluid inflating the balloon; anda tip portion located distal to the inflatable balloon, the tip portion comprising an atraumatic flexible tip for deterring movement of the catheter when the catheter is temporarily placed inside a chamber of the heart, the atraumatic flexible tip having a curved shape at a distal portion of the atraumatic flexible tip.

2. The heart valve catheter of claim 1, wherein the high energy acoustic waves are adapted to break up and / or remove calcification from calcified heart valve leaflets.

3. The heart valve catheter of claim 1 , wherein the high energy acoustic waves are adapted to break up and / or remove calcification from the heart valve region.

4. The heart valve catheter of any of claims 1-3, wherein the curved shape of the atraumatic flexible tip is a circular shape and the distal portion of the atraumatic flexible tip is connected to or integral with a straight portion of the atraumatic tip.

5. The heart valve catheter of claim 4, wherein the circular shape is adjustable such that a length of the atraumatic flexible tip as measured from a proximal end to a distal end is adjustable.

6. The heart valve catheter of claim 5, wherein the atraumatic flexible tip includes an offset passageway extending lengthwise through the atraumatic flexible tip, and the offset passageway is separate from a central lumen through the atraumatic flexible tip for receivinga guide wire, and the offset passageway is configured to receive a pull wire for adjusting the circular shape of the atraumatic flexible tip.

7. The heart valve catheter of any of claims 4-6, wherein a diameter of the circular shape is between about 1.0 and about 7.0 centimeters.

8. The heart valve catheter of claim 7, wherein the diameter is between about 2.0 and about 4.0 centimeters.

9. The heart valve catheter of any of claims 4-8, wherein the straight portion of the atraumatic tip is integral with a central tube of the catheter, and the first and second electrodes are located on the central tube.

10. The heart valve catheter of any of claims 1-3, wherein the atraumatic tip includes a straight portion located proximal to the curved portion and the straight portion is removably connectable to a central tube of the catheter.

11. The heart valve catheter of any of claims 1-10, wherein the atraumatic tip is hollow and configured to receive a guide wire.

12. The heart valve catheter of any of claims 1-11, wherein a material that forms the atraumatic tip has a decreasing stiffness in a distal direction along at least a portion of the atraumatic tip.

13. The heart valve catheter of any of claims 1-12, wherein the curved portion of the atraumatic tip is deformable.

14. The heart valve catheter of any of claims 1-3, wherein the atraumatic tip includes a straight portion having a passageway to permit blood blow through the atraumatic tip and a central tube of the catheter.

15. The catheter of any of claims 1-14, further comprising a third electrode and a fourth electrode located inside the balloon that form a second emitter, the third and fourth electrodes connectable at the proximal portion of the catheter to the electrical source to generate a highvoltage pulse, thereby creating a spark across the second emitter through the conductive medium to perform a second high energy acoustic lithotripsy operation in parallel with the first high energy acoustic lithotripsy of a heart valve region operation.

16. A system for performing high energy acoustic lithotripsy of a calcified heart valve of a subject, the system comprising:a high voltage pulse generator; anda catheter having a distal portion provided with an inflatable ballon, the inflatable balloon connectable to a source for providing a conductive medium to inflate the balloon;first and second electrodes located inside the balloon to form a first emitter, the first and second electrodes electrically connected to the high voltage pulse generator such that when a high voltage pulse is generated, a spark is created across the first emitter through the conductive medium to perform high energy acoustic lithotripsy treatment of calcified lesions of the calcified heart valve to break up and / or remove calcifications from the heart valve region; anda curved tip on a distal portion of the catheter to temporarily anchor the catheter in position for performing the high energy acoustic lithotripsy treatment.

17. The system of claim 16, wherein the curved tip comprises a straight portion and a curved portion distal to the straight portion, and a stiffness of the curved portion is less than a stiffness of the straight portion.

18. The system of claim 17, wherein the curved portion of the curved tip is a deformable pig tail shape.

19. The system of claim 18, wherein the pig tail shape is deformed to adjust a length of the curved tip from a proximal end to a distal end of the curved tip.20 The system of any of claims 16-19, wherein the catheter comprises a central tube that runs through the balloon and the first and second electrodes are located on the central tube inside the ballon, and the curved tip is removably attached to a distal end of the central tube.

21. The system of any of claims 16-19, wherein the catheter comprises a central tube that runs through the balloon and the first and second electrodes are located on the central tube inside the ballon, and the curved tip is integral to a distal portion of the central tube.

22. The system of any of claims 16-21, further comprising a control system for controlling the high voltage pulse from the high voltage pulse generator, and the generated high voltage pulse is between about 3000 and about 5000 volts.

23. The system of claim 22, wherein the control system controls deflating and inflating the balloon, and the balloon is inflated to a pressure between about 4 and about 10 atm.

24. A method of performing a medical procedure on a subject to modify calcifications on a heart valve using a catheter having an inflatable balloon and an atraumatic tip on a distal end of the catheter, the method comprising:inserting the inflatable balloon into a chamber of a heart of the subject in proximity to a heart valve, the inflatable balloon comprising a conductive medium inside the balloon; using the atraumatic tip to position the catheter inside the chamber and limit or prevent movement of the catheter in an axial direction, the atraumatic tip having a curved portion;inflating the balloon such that an exterior surface of the balloon is in contact with one or more leaflets of the heart valve to break up calcifications on the one or more leaflets; and providing a high voltage pulse from a high voltage pulse generator to create a spark from an emitter for creating an energy wave for propagation through the fluid within the balloon to provide force from the balloon to break up the calcifications.

25. The method of claim 24, wherein using the atraumatic tip to position the catheter inside the chamber includes contacting an interior wall of the chamber with the curved portion of the atraumatic tip.

26. The method of claim 25, wherein the curved portion of the tip deforms when it contacts the interior wall.

27. The method of any of claims 24-26, wherein inserting the inflatable balloon into the heart includes inserting the inflatable balloon in a deflated state and inflating the balloon once the balloon is inside the interior of the heart.

28. The method of any of claims 24-27, wherein the valve is an aortic valve.

29. The method of any of claims 24-28, further comprising: controlling the high voltage pulse generator to control an amount and frequency of the high voltage pulse from the high voltage pulse generator.

30. The method of any of claims 24-29, further comprising: controlling an inflation and deflation of the balloon.

31. The method of claim 30, inflating the balloon includes inflating the balloon to pressures between about 4 atm and about 10 atm.

Images