Dual-function balloon and catheter system for coronary calcium modification

Abstract

A system and method for modifying calcifications on a heart valve includes a dual-function heart valve catheter for performing a cutting operation and an intravascular lithotripsy (IVL) operation. The dual-function heart valve catheter includes an inflatable balloon having a cutting feature on an outer surface of the balloon such that, when the balloon is inflated, the cutting feature cuts or abrades calcification regions on the heart valve. The dual-function heart valve catheter includes first and second electrodes inside the balloon for generating a high voltage pulse from an electrical source, thereby creating a spark through a conductive medium inside the balloon to perform IVL on the calcification regions. The cutting and IVL operations can be repeated as appropriate to effectively treat the calcium legions, including moving and repositioning the catheter within the heart.

Description

DUAL-FUNCTION BALLOON AND CATHETER SYSTEM FOR CORONARY CALCIUM MODIFICATIONPRIORITY CLAIM

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 71 1 ,901), filed on October 25, 2024, which is incorporated by reference herein 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. I) 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 narro wed (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 thatcalcify, 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 front 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 alternati ves. For many patients, repair of the val ve, particularly if non-mvasive, may be preferable to valve replacement.SUMMARY

[0008] A. dual- function heart valve catheter can be used for repairing a calcified heart valve of a subject. The dual-function heart valve catheter can include 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. The dual-function heart valve catheter can also include first and second electrodes located inside the balloon to form a fust emitter, and one or more cutting features on an outer surface of the balloon to create cuts or abrasions in the calcification regions of one or more valve leaflets when the balloon is inflated within the calcified heart valve. The first and second electrodes can be connectable at the proximal portion of the catheter to an electrical source to generate a high voltage pulse, thereby creating a spark across the first emitter through the conductive medium to perform a first in travascular lithotripsy (IVL) operation on calcification lesions of the calcified heart valve. The first IVL operation and the one or more cutting features can function to break up and / or remove calcification from the heart valve.

[0009] A. system for performing an 1 VL operation and a cutting operation within a calcified heart valve of a subject can include a high, voltage pulse generator and a catheter having a distal end 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 the system can be located inside the balloon to form a first emitter, the first and second electrodes can be 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 theconductive medium to perform an IVL operation on calcification lesions of the calcified heart valve. At least one of a cutting blade or an abrasive feature on an outer surface of the balloon can perform a cutting operation to create cuts or abrasions in the calcification lesions of one or more valve leaflets when the balloon is inflated within the calcified heart valve. The IVL operation and the cutting operation can be used in combination to break up and / or remove calcification from the heart valve.

[0010] A method o f p erforming a medical procedure on a subj ec t to modify calcifications on a heart valve can use a catheter having an inflatable balloon. 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 inflating the balloon such that an exterior surface of the balloon is in contact with one or more leaflets of the heart valve and a cutting feature on the exterior surface of the balloon breaks up calcifications on the one or more leaflets. The method can also include 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. The cutting feature and the high voltage pulse generator can function together for efficacy in reducing and removing calcifications from the heart valve.BRIEF DESCRIPTION OF THE DRAWINGS

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

[0012] FIG. 1 is a schematic of a heart showing the chambers, valves and direction of blood flow.[0013j FIG. 2 is a top vi ew 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. I showing the aortic valve in an open position.

[0015] FIG. 4 is a schematic of the left side of the heart showi ng a calci fied aortic valve in an open position.

[0016] FIG. 5 illustrates a catheter system including a dual-function balloon for performing intravascular lithotripsy (IVL) and cutting, according to one or more embodiments of the present: disclosure.

[0017] FIG. 6 illustrates the dual-function balloon of FIG. 5 in an inflated state inside the heart for providing valve repair to a calcified heart valve, according to one or more embodiments of the present disclosure.

[0018] FIG. 7 illustrates a catheter system including a dual-function balloon for performing IVL and cutting, according to one or more embodiments of the present disclosure.

[0019] FIG. 8 illustrates a process flow chart of a method of reducing calcifications on a heart valve, according to one or more embodiments of the present disclosure.DETAILED DESCRIPTION

[0020] The present disclosure is directed to a dual-function (or dual-action) catheter system for treating a calcified heart valve. The dual-function heart valve catheter system includes an inflatable balloon that can be inflated with a conductive medium, such as saline, and one or more pairs of spaced electrodes with at least one electrode 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 genera ted, a spark is created across the one or more pairs of electrodes that can be connected in series or parallel through the conducti ve medium to perform intravascular lithotripsy (IVL). 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 dual-function heart valve catheter system preferably also includes one or more cutting features on an outside of the balloon such that when the balloon is inflated the cutting features can create cuts or abrasions for at least partially breaking up calcification regions on and around the calcified heart valve. Such cutting features can include an abrasive or roughened surface on the exterior of the balloon. The catheter sy stem facili ties combined use of an IVL opera tion and a cutting or abrading operation, thus providing improved functionality in removing / reducing calcifications to repair a calcified heart valve. The dual-function or dual-action catheter system described herein can be used as a less invasive alternative to valve replacement.

[0021] 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 asaline solution, for expanding the balloon in position at the lesion or thrombus, wherein the catheter system includes one or more pairs of electrodes 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 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 micro-bubbles that also facilitate the physical force. Such intra vascular 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 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 systems and methods of the present invention may include or be used with an energy source or generator or controller that is bespoken for procedures in the heart valve region of a patient.

[0022] The present disclosure focuses on using IVL for heart valves rather than a vascular application. By combining IVL with cutting or abrading, the dual-function heart valve catheter system described herein can effectively reduce and remove calcifications on an aortic valve or other valves in the heart. 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-iong 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 emiters that create high voltage sparks to provide the therapy against the lesion. Acoustic waves are created and the calcium is fractured. Multiple blades or other cutting / abrasive features on an exterior or outer surface of the balloon are designed to contact and cut or abrade into the calcifications when the balloon is inflated.

[0023] The blades or abrasive features on the balloon are configured to cu t Into or abrade a calcification or lesion as a result of the balloon being inflated and in proximity to / touching the calcium lesions. Thus, cuting and / or abrading occurs when the balloon isinflated. As described below, additional steps may be taken in furtherance of the cutting / abrading step - for example, rotating or repositioning the balloon, such as after a partial or full deflation of the bal loon, for subsequent engagement of the bl ades with the calcium lesions. Cutting / abrading can be performed simultaneously with IVL or separately. If the cutting and IVL operations do not adequately break up the calcium, the operations can be repeated, as described below.

[0024] FIG. 5 shows a system 100 according to the present invention comprising a power source 1 12 (in the form of an electrical generator, but alternati vely in the form of a laser system), a controller 113, a handle 1 14 with a therapy delivery switch 115, a catheter 120 having a central tube 126 with two lithotripsy emitters 122, and a balloon 124, 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 1 13 can be housed in the same unit as the power source 1 12 (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 posi tioning by use of known imaging techniques. In this illustrated embodiment, an exterior or outer surface of the balloon 124 includes multiple microblades (or cutting blades) 125 that are spaced apart from one another. A 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.

[0025] The balloon 124 can be filled with a conductive medium in order to inflate the balloon 124 and as such, the catheter I 20 can be connectable to a source for providing the conductive fluid or medium.

[0026] 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 oneembodiment, 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 1.2 atm.

[0027] FIG. 6 shows the balloon 124 in an inflated state and inside the heart in proximity to a calcified aortic valve 28’ of FIG. 4. .Although the focus herein is on repair of the calcified aortic valve, the present disclosure and dual function 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.

[0028] The central tube 126 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 surrounds the central tube 126 and defines a delivery lumen 129 through which saline can be controllably delivered for balloon inflation. The lumen 129 provides a concentric space around the central tube 126 within which electrode wires 130 can be run from the switch 1 15 to the emitters 122. The hub 1 17 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 .

[0029] 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.

[0030] Once in position with the balloon 124 inflated, 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.

[0031] 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 maximum 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 thesecond 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.

[0032] To aid or enhance tire 1VL operation in breaking up the calcifications 40. the balloon 124 preferably includes one or more cutting features on the exterior of the balloon 124. As shown in FIGs. 5 and 6, the cutting features can include the plurality of microblades 125 on the exterior of the balloon 124 to create small cuts or abrasions in one or more of the calcium lesions 40, The microblades 125 can extend from the exterior surface of the balloon124 such that when the balloon 124 is inflated in proximity to the calcium lesions 40, the microblades 125 cut into and at least partially break up the calcium. Upon inflation of the balloon 124, the microblades 125 in contact with the surrounding calcium provide a focused point of contact, creating elevated stress levels in the calcium . This increased stress in the calcium created by the microblades 125 facilitates the breaking up of the calcifications 40.

[0033] In some embodiments, the microblades 125 are spaced apart from one another in both a radial and an axial direction. The posi tion of the microblades 125 on the balloon 124, as well as the type and number of blades T25, can be varied and controlled for different catheter configurations. Such microblades 125 can extend axially or transversely along an exterior surface of the balloon 124. As such, the microblades 125 can cut into the calcium lesions 40 when the balloon is inflated and thereby comes into contact with the lesions 40.

[0034] Microbiades 125 can he pla ced on the balloon 124 irrespective of the location of the emitters 122, as the generated pulses from the emitters 122 disrupt calcium found between the microblades 125 and in areas where the microbiades 125 do not contact the calcium. In this way, the dual-action method (microblades and IVL pulse-generation) is able to break up a larger amount of calcium than either method independently. The microbiades125 can be formed from a variety of biocompatiblc metals, including, but not limited to, stainless-steel or titanium.

[0035] Other designs of the cutting features can be used in addition to or as an alternative to the microbiades 125 of FIGs. 5 and 6. FIG. 7 shows a portion of a system 200 according to the present invention comprising a catheter 220. The catheter 220 includes a balloon 224 which has cutting features or microbiades 227 on the exterior of the balloon 224 and extending along the length of the balloon 224 in the axial direction. In the example shown in FIG. 7. the microblades 227 cover the majority of the length of the balloon 224. although the microbiades 227 may only extend partially along the balloon 224 in the axialdirection. This design is an alternative to the shorter microblades 125 of FIG. 5 which are spaced apart along the length of the balloon 124.

[0036] As shown, in FIG. 7. there are plural microblades 227 spaced apart from one another, and additional microblades 227 can be included around a circumference of the balloon 224. In an example, the balloon 124 can include three microblades 227 equally spaced apart from one another, each microblade 227 extending along at least pan of the length of the balloon 224. In other designs, the balloon 224 can include shorter microblades relative to the microblades 227 of FIG. 7. In some designs, the balloon 224 can include shorter and longer microblades used in combination.

[0037] Although not shown in FIG. 7, the system 200 can opera te similar to the system 100 of FIG. 5 and can include a power source, controller, etc.

[0038] The use of blades 125 or 227 in combination wi th IVL can reduce the amount of energy required to treat the calcium lesions 40 with lithotripsy pulses. For example, fewer total pulses may be needed to achieve sufficient de-ealcification, thus extending the life of the device and / or increasing the likelihood of procedural success in valve repair. In some embodiments, a balloon 124 or 224 can be inflated causing a. cutting or abrading action followed by an I VL treatment and then deflated at least partially to be repositioned in respect to the treated valve or leaflet and reinflated at a new location to cause another cutting or abrading action. Such cuting or abrading actions can be done a plurality of times in the same location or in different locations with one or any plurality of I VL treatments. In some embodiments, the balloon 124 or 224 is deflated and then repositioned or rotated, followed by inflation and repeated steps of cutting and IVL. In other embodiments, the balloon 124 or 224, once inflated, is static.

[0039] As provided above, any type of microbiade that is attachable to the balloon 124 / 224 and suitable for use on a catheter can be used here. As an alternative or in addition to the microblades 125 or 227, a portion of the exterior of the balloon can be roughened or otherwise abrasive for engagement with and disruption of the calcium lesions.

[0040] As described above, the controller 1 13 of FIG. 5 is used to deliver voltage pulses as described above. The controller 113 can thus regulate delivery of such voltage pulses (IVL) in terms of pressure and frequency. The controller 113 can also regulate operation of the cutting blades 125. In some embodiments, the regulation or control of each operation is done independently of the other. In some embodiments, the two operations (IVL and cutting) are not performed at the same time. In some embodiments, the two operations are performed sequentially and repeatedly, in an example, the cutting operation is performedfirst, followed by IVL and then the steps can be repeated, (See further details below in reference to FIG. 8.) Control of the cutting and IVL operations is a function, in part, of the extent of calcification. The dual-action method described herein provides options for treatment,

[0041] Control of each system by the controller 1 13 can be done including manual manipulation by an operator, such as to switch from an IVL operation to a cutting operation and vice versa. Alternatively, some or all of the steps of each operation and / or switching from one to another operation can be automated. The controller 1 13 can include any number of control modules for switching from one operation to another, such as utilizing electronic switches, or for controlling part or al l of each sizing and / or IVL system operation. The controller 1 13 can also assist in automating the inflation and deflation of the ballon through an internal air 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.

[0042] The systems 100 and 200 can include catheters 120, 220 in a range of sizes, including a range of sizes for the balloons 124, 224, such that the systems 100, 200 can accommodate variabi lity in patient anatomy and / or differences in size of the ventricles / atriums and heart valve anmtli. 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.

[0043] Gi ven 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 aim 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 thevalve 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.

[0044] 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 atach) 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 ean 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,

[0045] FIG. 8 shows a method 300 for performing a medical procedure on a subject to modify (i.e. remove or reduce) calcifications on a heart valve of the subject. At step 310, the procedure begins by positioning the dual-action balloon catheter within a calcified heart valve. At step 312, the balloon is then inflated, engaging the externally positioned cutting features (microblades or abrasive surface) with the surrounding calcium, disrupting the calcium. If the operator(s) decides at step 314 to conduct IVL treatment, the operator can activate one or more, or a series of IVL pulses at step 316 to further break up the calcium. At step 318, the operator! s) determines 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.

[0046] If additional locations of calcium require treatment, the ballon can then, be deflated or partially deflated at step 320 -- this allows the operator to reposition and / or rotate the balloon at step 322. Such repositioning can include, for example, moving an axial position of the balloon in the heart. The process then repeats until die operator determines at step 318 that the calcium has been fully or adequately treated. If no iurthci treatment is needed at step 318, then at step 324 the balloon is deflated and the balloon can be removed, thus ending the procedure at step 326.

[0047] 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, internipt 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.

[0048] 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, EEPR.OM, 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).

[0049] 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.

[0050] 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 wi thin 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 dual-function heart valve catheter for repairing a calci fied 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 an electrical source to generate a high voltage pulse, thereby creating a spark across the first emitter through the conductive medium to perform a first intravascular lithotripsy (IVL) operation on calcificat ion lesions of the calcified heart val ve; and one or more cutting features on an outer surface of the balloon to create cuts or abrasions in the calcification regions of one or more valve leaflets when the balloon is inflated within the calcified heart valve, wherein the first I VI, operation and the one or more cutting features function to break up and / or remove calcification from the heart valve.

2. The system of claim 1 , wherein the catheter further comprises 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 high voltage pulse, thereby creating a spark across the second emitter through the conductive medium to perform a second I VL operation in. parallel with the first 1VL operation.

3. The system of claim 1 , wherein the one or more cutting features comprise a plurality of microblades attached to the outer surface of the balloon.

4. The system of claim 3, wherein each microblade in the plurality of microblades extends along a length of the balloon.

5. The system of claim 4, wherein the plurality of microb lades is three microblades, each microblade equally spaced around a circumference of the balloon.

6. The system of claim 3, w herein the one or more cutting features comprises a roughened surface on at least a portion of the outer surface of the balloon.

7. The system of claim I, wherein the conductive medium is acoustic energy conductive.

8. A system for performing an intravascular lithotripsy (IVL) operation and a cutting operation within a calcified heart valve of a subject, the system comprising: a high voltage pulse generator; and a catheter having a distal end 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 an IVL operation on calcification lesions of the calcified heart valve; and at least one of a cu tting blade or an abrasive feature on an outer surface of the bal loon to perform a cutting operation to create cuts or abrasions in the calcification lesions of one or more valve leaflets when the balloon is inflated within the calcified heart valve, wherein the IVL operation and the cutting operation arc used in combination to break up and / or remove calcification from the heart valve.

9. The system of claim 8, wherein the cutting blade comprises a plurality of microblades spaced apart radially and longitudinally on the outer surface of the balloon.

10. The system of claim 8, wherein the cutting blade comprises a plurality of microblades equally spaced apart around a circumference of the outer surface of the balloon, each microblade extending along a length of the balloon.11 . The system of claim 8, wherein the catheter further comprises a third electrode and a fourth electrode located inside the balloon that form. a second emitter, the third and fourth electrodes electrically connected to the high voltage pulse generator such that when a high voltage pulse is generated, a spark is created across rhe second emitter through the conductivemedium and an IVL operation is performed by the second emitter in parallel with an IVL operation of the first emitter.12, The sys tem of claim 8 , further comprising a control system for controlling the high voltage pulse from the high voltage puise generator.13, The system of claim 12, wherein the control system controls the one or more cutting blades,14, The system of claim 12, wherein the control system controls deflating and inflating the balloon.15, A method of performing a medical procedure on a subject to modify calcifications on a heart valve using a catheter having an inflatable balloon, the method comprising: inserting the inflatable balloon into a chamber of a heart of the subjec t hi proximi ty to a heart valve, the inflatable balloon comprising a conductive medium inside the balloon; inflating the balloon such that an exterior surface of the balloon is in contact with one or more leaflets of the heart valve and a cutting feature on the exterior surface of the balloon breaks 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, wherein the cutting feature and the high voltage pulse generator function together for efficacy in reducing and removing calcifications from the heart valve.16, The method of claim 15, 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.17, The method of claim 15, wherein the valve is an aortic valve.18, The method of claim 15, 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.19, The method of claim 15, further comprising: after providing the high voltage pulse, determining whether additional treatment is appropriate.

20. The method of claim 19, wherein if addi tional treatment is determined to be appropriate, the method further comprises: at least partially deflating the balloon and moving the deflated balloon to a second position in the chamber; and repeating the inflating and providing steps, wherein deflating and inflating of the balloon is controlled via a control system.

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