Integrated balloon system for hemodynamically stable valvuloplasty and in-SITU lithotripsy

Abstract

An integrated balloon system is provided for performing hemodynamically stable valvuloplasty and in-situ lithotripsy. A hollow cylindrical balloon with a central lumen open at both ends and a surrounding annular inflation chamber. Valve-like leaflets within the central lumen permit unidirectional blood flow from the left ventricle to the aorta, maintaining forward flow during balloon inflation. The balloon is mounted on a double-lumen catheter shaft one lumen for a guidewire and the other for contrast delivery and aspiration. Circumferentially arranged lithotripsy energy-emitting elements within the annular chamber are connected to an external power generator. Upon inflation, these elements come in close proximity to the calcified valve tissue and deliver energy pulses to disrupt calcium and improve valve compliance. The system enables effective valve dilation without requiring rapid pacing and supports simultaneous lithotripsy and blood flow maintenance. Useful in prosthetic aortic valve implantation with prolonged inflation as required, without hemodynamic compromise.

Description

INTEGRATED BALLOON SYSTEM FOR HEMODYNAMICALLY STABLE VALVULOPLASTY AND IN-SITU LITHOTRIPSYTECHNICAL FIELD

[0001] The disclosed subject matter relates generally to interventional medical devices used in the treatment of valvular heart diseases. More particularly, the present invention pertains to an integrated balloon system featuring a hollow cylindrical design with internal valve leaflets and embedded lithotripsy energy emitting elements, which enables hemodynamically stable valvuloplasty procedures while simultaneously facilitating in-situ modification of valvular and annular calcifications.BACKGROUND

[0002] Aortic valve stenosis is a progressive cardiac condition in which the aortic valve becomes thickened and exhibits restricted mobility. As the valve narrows, it limits the outflow of blood from the left ventricle (LV) into the aorta, increasing cardiac workload and leading to clinical symptoms such as shortness of breath, chest discomfort, or syncope. In severe cases, if left untreated, the condition can result in heart failure or sudden cardiac death. Management of severe aortic stenosis typically involves aortic valve replacement, either through surgical means or minimally invasive transcatheter techniques. In select cases, balloon aortic valvuloplasty is performed to temporarily relieve stenosis by mechanically dilating the narrowed valve. However, these procedures are often complicated by the presence of heavy calcification on the valve leaflets and annulus, especially in elderly patients, those with congenital bicuspid valves, or individuals with chronic kidney disease.

[0003] Calcified valves present multiple procedural challenges. During balloon valvuloplasty or transcatheter valve implantation, the rigid calcium deposits may hinder complete balloon expansion or cause asymmetric deployment of prosthetic valves. These technical failures can lead to serious complications such as paravalvular leakage, coronary obstruction, conduction abnormalities like complete heart block, or in rare cases, annular rupture.

[0004] Another challenge encountered during the Aortic Valvuloplasty procedure arises when the balloon is inflated across the aortic valve. At this stage, the inflated balloon fully obstructs the flow of blood from the left ventricle to the aorta. As a result, the left ventricle generates significantly elevated pressure in an attempt to overcome the obstruction and eject blood into the aorta. This sudden surge of force can displace the balloon from its intended position, thereby preventing effective dilatation of the aortic valve.

[0005] The problem of maintaining balloon stability across the aortic valve during inflation is currently managed by rapid ventricular pacing. This technique temporarily reduces cardiac output to counteract the pressure exerted by the LV against the balloon, thereby allowing short-duration inflation. However, rapid pacing itself is an additional invasive intervention requiring temporary pacemaker insertion. It carries inherent risks such as cardiac perforation, intractable arrhythmias, and overall procedural complexity. Furthermore, rapid pacing does not address the hemodynamic instability caused by complete obstruction of blood flow from the LV to the aorta during balloon inflation. Even brief periods of complete outflow occlusion can result in hypotension, decreased perfusion to vital organs, and life-threatening cardiovascular compromise.

[0006] Another set of limitations arises in the context of calcium modification during valvuloplasty. The problems posed by calcified aortic valves are currently addressed using balloon dilation alone, which typically displaces the calcium to permit partial valve opening. However, this method does not fracture or remodel the calcium effectively. Persistent valvular or annular calcification may impair full prosthetic valve expansion, leading to suboptimal clinical outcomes including valve dysfunction, paravalvular leakage, and increased likelihood of complications such as complete heart block or the often fatal annular rupture. Adequate modification of the calcium is therefore essential for safer and more durable valve interventions.

[0007] In addition to dilation, modification of calcific burden using lithotripsy has gained attention. Lithotripsy employs shockwaves to fracture calcium deposits and improve valve compliance. However, current catheter designs position lithotripsy energy emitting elements along a central shaft, which may be too distant from the calcified structures in patients with largeaortic annuli. This reduces the effectiveness of energy delivery. Compounding the problem is the need for prolonged balloon inflation to deliver adequate pulses — yet such inflation obstructs blood flow entirely, leading to dangerous hypotension.

[0008] In light of the existing problems and limitations, the invention provides a novel solution that enables hemodynamically stable aortic valvuloplasty with in-situ effective lithotripsy, enhancing both procedural safety and therapeutic outcomes.SUMMARY

[0009] The following invention presents a simplified summary of the disclosure in order to provide a basic understanding to the reader. This summary is not an extensive overview of the disclosure and it does not identify key / critical elements of the invention or delineate the scope of the invention. Its sole purpose is to present some concepts disclosed herein in a simplified form as a prelude to the more detailed description that is presented later.

[0010] The exemplary embodiments of the present disclosure pertain to integrated balloon system for hemodynamically stable valvuloplasty and in-situ lithotripsy.

[0011] The objective of the present disclosure is to provide an integrated balloon system for valvuloplasty that maintains forward blood flow from the left ventricle to the aorta during balloon inflation, thereby ensuring hemodynamic stability throughout the procedure.

[0012] Another objective of the present disclosure is to reduce the risk of complications such as cardiac perforation, arrhythmias, and hemodynamic compromise associated with temporary pacemaker insertion during current valvuloplasty procedures.

[0013] Another objective of the present disclosure is to facilitate prolonged balloon inflation without obstructing blood flow, thus allowing extended and effective treatment durations without inducing hypotension or ischemia.

[0014] Another objective of the present disclosure is to prevent aortic regurgitation during balloon inflation by incorporating valve-like leaflet structures within the central lumen of the balloon to maintain unidirectional blood flow.

[0015] Another objective of the present disclosure is to enable efficient and targeted modification of calcified aortic valve and annular tissues by positioning lithotripsy energyemitting elements circumferentially around the balloon. This circumferential placement of energy emitting elements brings them close to the calcified tissues ensuring adequate energy delivery for proper calcium modification.

[0016] Another objective of the present disclosure is to improve procedural outcomes of transcatheter aortic valve implantation (TAVI) by allowing adequate calcium modification, thereby reducing the risks of prosthetic valve under-expansion, paravalvular leak, complete heart block, and annular rupture.

[0017] Another objective of the present disclosure is to offer a dual-purpose interventional device capable of performing both valvuloplasty and in-situ lithotripsy using a single, integrated system.

[0018] Another objective of the present disclosure is to provide a balloon device that can be mounted either eccentrically or centrally on a catheter shaft, offering versatility in clinical use and compatibility with various anatomical scenarios.

[0019] In an exemplary aspect of the present disclosure, the integrated balloon system is configured to maintain continuous forward blood flow from the left ventricle (LV) to the aorta during balloon inflation. This is achieved by employing a hollow cylindrical balloon design with a central lumen that remains open even when the balloon is fully inflated. This aspect addresses the hemodynamic instability traditionally encountered during valvuloplasty procedures, allowing uninterrupted cardiac output throughout the intervention.

[0020] In another exemplary aspect of the present disclosure, the central lumen of the balloon includes valve-like leaflet structures attached to its inner wall. These mobile leaflet componentspermit unidirectional blood flow during systole while preventing regurgitation during diastole. This functional aspect provides a physiological flow profile during balloon inflation and minimizes the risk of hypotension or pulmonary edema caused by retrograde blood flow into the LV.

[0021] In another exemplary aspect of the present disclosure, the system is designed to eliminate the need for rapid ventricular pacing — a currently practiced method to stabilize the balloon during inflation. The disclosed balloon maintains its position across the aortic valve without requiring pacing by virtue of its shape, internal flow design, and thereby avoiding complications such as cardiac perforation and arrhythmias associated with temporary pacemaker insertion.

[0022] In another exemplary aspect of the present disclosure, the balloon allows for prolonged and effective dilation of the aortic valve. The continuous flow through the central lumen and stability of the balloon enable longer inflation times, ensuring adequate mechanical dilatation without life-threatening compromise of systemic circulation.

[0023] In another exemplary aspect of the present disclosure, the balloon system incorporates lithotripsy capability by carrying a series of energy emitting elements circumferentially around the peripheral chamber of the balloon. These energy emitting elements such as electrodes are in close proximity to the calcified aortic valve leaflets and annular structures when the balloon is inflated. This placement allows for efficient and focused delivery of energy pulses, enhancing calcium modification and ensuring better expansion of prosthetic valves.

[0024] In another exemplary aspect of the present disclosure, the balloon system comprises a dual-lumen catheter shaft — one lumen to accommodate a guidewire and another to transmit diluted contrast fluid into the peripheral chamber of the balloon. The shaft further accommodates energy-carrying elements for lithotripsy, including but not limited to electrodes or optical fibers, enabling targeted disruption of calcified lesions during the procedure. The contrast inflation lumen is connected to a proximal port, which allows for expansion or deflation of the balloon using a syringe or indeflator. This setup provides precise control during balloon deployment,inflation, and retraction, while integrating multifunctional capabilities for enhanced therapeutic outcomes.

[0025] In an exemplary embodiment of the present disclosure, the hollow cylindrical balloon is eccentrically mounted at the distal end of the catheter shaft. This eccentric configuration allows free flow of blood through the central lumen of the balloon during balloon inflation, thereby maintaining hemodynamic stability while facilitating effective dilation of the stenosed aortic valve.

[0026] In another exemplary embodiment of the present disclosure, the balloon is centrally mounted and supported by spoke-like structures that connect the peripheral chamber of the balloon to a central catheter shaft. These spokes provide structural support to the balloon while simultaneously allowing blood to flow through the gaps between the spokes. This configuration provides symmetrical radial expansion and evenly distributed force around the valve annulus, which may be particularly advantageous in anatomically symmetric or heavily calcified valve scenarios.

[0027] Both embodiments are compatible with standard guidewire-based navigation techniques. During aortic valvuloplasty or pre- / post-dilatation in transcatheter aortic valve implantation (TAVI), the device is advanced over a guidewire already positioned across the aortic valve. Once in position, diluted contrast is injected into the peripheral chamber to inflate the balloon to the desired pressure. The inflation of the balloon, while maintaining central flow and preventing regurgitation, facilitates safe and effective dilation without requiring rapid pacing.

[0028] In cases requiring calcium modification, lithotripsy pulses are delivered through the circumferential energy emitting elements carried within the annular balloon chamber, providing effective treatment to calcified regions. Following completion of the procedure, the contrast is aspirated to deflate the balloon, which is then withdrawn safely over the guidewire.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG. 1 illustrates an exemplary anatomical view of the aortic arch and ascending aorta showing the deployment of the integrated balloon system across the aortic valve region. The figure demonstrates the positioning of the hollow cylindrical valved balloon connected to a catheter shaft within the vascular anatomy, emphasizing its orientation relative to the aortic valve and ascending aorta.

[0030] FIG. 2A illustrates another exemplary perspective view of a variant of the integrated balloon system, also with an eccentrically mounted balloon. This version includes a doublelumen shaft configuration with a central lumen for guidewire passage and a side port connected to an inflation lumen, enabling independent control of balloon inflation and functional deployment.

[0031] FIG. 2B illustrates an exemplary perspective view of the integrated balloon system featuring a hollow cylindrical balloon with an eccentrically positioned catheter shaft. The figure shows key components such as the shaft, fill ports, central lumen, annular enclosed space, and internal balloon valve leaflets, highlighting the internal flow and directional control structure.

[0032] FIG. 2C illustrates a cross-sectional view of the hollow cylindrical balloon showing the configuration of the internal balloon valve leaflets emphasizing the directional blood flow mechanism. The figure also shows the catheter shaft extending eccentrically into the structure.

[0033] FIG. 2D illustrates a sectional side view of the balloon, depicting the internal anatomy including the central lumen, surrounding annular enclosed space, and the balloon valve leaflets. The figure highlights the structural arrangement enabling one-way flow during systole.

[0034] FIG. 2E illustrates a perspective view of the balloon incorporating a lithotripsy system. The figure shows the arrangement of energy emitting elements or optical fibers for lithotripsy in the annular inflatable enclosed space of the balloon and supported by conducting materials and structural elements for effective calcium modification.

[0035] FIG. 3 illustrates an exemplary anatomical view of the integrated balloon system featuring a centrally mounted balloon supported by spoke-like structures. The figure shows the orientation of the system within the aorta and left ventricle, highlighting components such as the catheter shaft, hollow cylindrical shaped balloon with central shaft, balloon valve leaflets, guidewire, and the thickened aortic valve across which the balloon is deployed.

[0036] FIG. 4A illustrates a perspective view of the integrated balloon system featuring a centrally mounted balloon supported by spoke-like connectors extending from a central shaft. The figure highlights the internal valve leaflets, annular enclosed space, fill ports, and double lumen shaft configuration.

[0037] FIG. 4B illustrates a partial sectional view of the balloon system showing the integration of lithotripsy components. It depicts the internal arrangement of the central lumen, inflation lumen, lithotripsy conducting elements, arranged longitudinally within the annular enclosed space.

[0038] FIG. 4C illustrates a cross-sectional view of the centrally mounted integrated balloon system, showing the central lumen with internal valve leaflets, a centrally placed shaft with guidewire lumen. Also seen are inflation fluid channel and lithotripsy energy conduction channels positioned within the annular space.

[0039] FIG. 5 A illustrates a schematic representation of the integrated balloon system connected to a power generator for lithotripsy functionality. The figure shows the hollow cylinder shaped balloon mounted on central shaft supported by spokes on both ends proximally and distally, energy emitting elements for lithotripsy and a double lumen catheter shaft, highlighting the electrical setup used to power and control the lithotripsy energy emitting elements integrated within the system.

[0040] FIG. 5B illustrates a sectional view of the balloon system showing the internal structural arrangement for lithotripsy functionality. The figure depicts the spokes, lithotripsy conducting elements, inflation lumen, fill ports, and the annular enclosed space, along with longitudinally positioned lithotripsy energy emitting elements in the annular enclosed space for targeted calcium modification.

[0041] FIG. 6 A illustrates a perspective view of the integrated balloon system configured for transcatheter aortic valve implantation (TAVI), showing the central shaft, hollow cylinder shaped balloon with prosthetic aortic valve crimped / mounted on it, supporting spokes, and the double lumen shaft.

[0042] FIG. 6B illustrates a cross-sectional view of the integrated balloon system with an aortic prosthetic valve mounted on it, showing the central shaft hollow cylinder balloon, central lumen, valve leaflets, surrounding annular space, and channels for inflation fluid.

[0043] FIG. 7 illustrates an exemplary procedural flow diagram for using the integrated balloon system in aortic valvuloplasty. The flow outlines the steps involved in positioning, inflating, and deflating the balloon across the stenotic aortic valve, enabling mechanical dilation while maintaining forward blood flow.

[0044] FIG. 8 illustrates an exemplary procedural flow diagram for using the integrated balloon system with lithotripsy functionality. The flow represents the steps required to deliver lithotripsy pulses in conjunction with balloon dilation for effective modification of calcified aortic valve tissue.DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0045] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0046] The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms “first”, “second”, and “third”, and so forth, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

[0047] Referring to FIG. 1, it illustrates an exemplary anatomical view of the aortic arch and ascending aorta showing the deployment of the integrated balloon system across the aortic valve region. The figure demonstrates the positioning of the hollow cylindrical valved balloon connected to a catheter shaft within the vascular anatomy, emphasizing its orientation relative to the aortic valve and ascending aorta.

[0048] In this view, the overall image is denoted by reference numeral 100. The catheter shaft 102 with a distensible balloon 108 at the distal end, may be introduced through the vascular system and advanced into the aorta 104 to reach the aortic valve. The thickened aortic valve 106, which may be stenosed and calcified, is shown in a constricted state that requires dilation for improved blood flow. Positioned across the thickened aortic valve is the balloon 108, which may be of a hollow cylindrical configuration allowing for inflation while preserving a central lumen. Within this balloon, balloon valve leaflets 110 may be present, which are oriented to allow unidirectional flow of blood from the left ventricle to the aorta, and to prevent regurgitation during diastole. A guidewire 112 is shown traversing the catheter shaft and passing through the balloon and valve region with its distal tip placed in left ventricle 114, which may aid in the accurate navigation and placement of the balloon system.

[0049] This arrangement may provide hemodynamic stability during balloon inflation and enable simultaneous valvuloplasty and in-situ lithotripsy, addressing challenges typically associated with conventional balloon dilation techniques.

[0050] Referring to FIG. 2 A, it illustrates another exemplary perspective view of a variant of the integrated balloon system, also with an eccentrically mounted balloon. This version includes a double-lumen shaft configuration with a central lumen for guidewire passage and an inflation lumen connected to a side port, enabling independent control of balloon inflation and functional deployment.

[0051] The overall image 200A depicts a configuration in which the balloon 210A is mounted eccentrically with respect to the double lumen shaft 208A. The central lumen 202A, which may be designated for the passage of a guidewire 212A, runs through the shaft and the balloon, assisting in proper device navigation and alignment during valvuloplasty or lithotripsy. The side port 204A may be configured to deliver fluid into the inflation lumen 206A, which in turn communicates with the annular enclosed space 216A of the balloon through fill ports 218A. This allows the balloon to be selectively inflated to exert radial force on the valve.

[0052] Additionally, the central lumen 214A within the balloon may remain open during inflation to maintain forward blood flow, while the surrounding annular enclosed space 216A may provide circumferential expansion. This arrangement, together with the eccentric positioning, allows for the unobstructed flow of blood from left ventricle to Aorta through the central lumen of balloon during balloon inflation.

[0053] Referring to FIG. 2B, it illustrates an exemplary perspective view of the integrated balloon system featuring a hollow cylindrical balloon with an eccentrically positioned catheter shaft. The figure shows key components such as the shaft, fill ports, central lumen, annular enclosed space, and internal balloon valve leaflets, highlighting the internal flow and directional flow control structure.

[0054] The overall image 200B represents the configuration of the balloon system as a standalone device component. The shaft 202B with the balloon attached in the distal end may serve as the primary body for introducing and positioning the balloon within the cardiovascular anatomy. The balloon is hollow cylindrical shaped with a central lumen 206B extending longitudinally through the balloon, remaining open even during inflation to allow forward flow of blood from the left ventricle to the aorta. Surrounding this central passage, the annular enclosed space 208B may act as the inflatable chamber, which upon expansion, may exert the necessary radial pressure on the stenotic aortic valve for dilation purposes. Within the central lumen, balloon valve leaflets 21 OB may be positioned and configured to enable unidirectional blood flow during systole while preventing backflow during diastole, thereby maintaining hemodynamic stability during the procedure.

[0055] This configuration may enable the balloon to perform both valvuloplasty and support in-situ lithotripsy while preserving physiological blood flow dynamics, addressing limitations associated with conventional balloon-based interventions.

[0056] Referring to FIG. 2C, it illustrates a cross sectional view of the hollow cylindrical balloon showing the configuration of the internal balloon valve leaflets. The figure also shows the catheter shaft positioned eccentrically into the structure.

[0057] The overall image 200C represents a front cross-sectional perspective of the balloon assembly. Within the central lumen, the balloon valve leaflets 202C are clearly depicted, which may be designed to function as unidirectional flow controllers. These leaflets may open during systole to allow forward ejection of blood from the left ventricle into the aorta and may close during diastole to prevent retrograde flow, thus supporting physiological hemodynamics even during balloon inflation. The shaft 204C is shown entering the balloon eccentrically, which may aid in maneuverability and optimal alignment during insertion. This configuration may provide a clear path for blood to flow through the central lumen of the balloon while maintaining control over flow direction, ultimately enhancing procedural safety and stability.

[0058] Referring to FIG. 2D, it illustrates a longitudinal section view of the balloon, depicting the internal anatomy including the balloon central lumen, surrounding annular enclosed space, and the balloon valve leaflets. The figure highlights the structural arrangement enabling one-way flow during systole through the central lumen balloon.

[0059] The overall image 200D shows a longitudinal cross-section of the hollow cylindrical balloon structure. At the core of the design, the central lumen 204D may remain open during balloon inflation to permit continuous blood flow from the left ventricle to the aorta. Positioned within this lumen, the balloon valve leaflets 202D may be configured to open during systole, allowing forward blood flow, and to close during diastole, thereby preventing regurgitation into the ventricle. Surrounding this lumen, the annular enclosed space 206D may serve as the inflatable chamber that exerts radial force for valve dilation when filled with contrast or other suitable fluid. This sectional view underscores the functional integration of the central flow pathway and leaflet valves within an expandable peripheral chamber, which together may contribute to maintaining hemodynamic stability during interventional procedures.

[0060] Referring to FIG. 2E, it illustrates a perspective view of the balloon incorporating a lithotripsy system. The figure shows the arrangement of energy emitting elements or optical fibers for lithotripsy passing through the annular enclosed space and supported by conducting materials and structural elements for calcium modification.

[0061] The overall image 200E presents a design in which the lithotripsy functionality is integrated into the balloon architecture. The conducting material 202E may be used to transmit energy — such as electrical pulses or laser — from an external power source to the treatment site. These conducting elements may run along or within the balloon structure to ensure uniform distribution of energy. The supporting element 204E may provide mechanical stability and positional accuracy for the energy delivery components. Embedded within this configuration, the energy emitting elements or optical fibers 206E run through the annular enclosed space and may be strategically spaced as required, enabling targeted disruption of calcific deposits during valvuloplasty. This arrangement allows for the lithotripsy energy emitting elements to come in close proximity to the annular and valvular calcium resulting in an efficient in-situ lithotripsywithout impeding forward blood flow, offering both mechanical dilation and calcium modification within a single device platform.

[0062] Referring to FIG. 3, it illustrates an exemplary anatomical view of the integrated balloon system featuring a centrally mounted balloon supported by spoke-like structures. The figure shows the orientation of the system within the aorta and left ventricle, highlighting components such as the catheter shaft, hollow cylindrical shaped balloon, balloon valve leaflets, guidewire, and the thickened aortic valve across which the balloon is deployed.

[0063] The overall image 300 demonstrates the positioning of the balloon system during a transcatheter procedure. The catheter shaft 302 with the balloon attached to its distal end, may be advanced through the aorta 304 and navigated to the aortic valve 316 with the aid of a guidewire 310, whose tip is positioned in the left ventricle 312. The central shaft balloon 314 is mounted in line with the catheter shaft and may be supported by spokes 308, which help maintain the balloon’s axial alignment and stability during inflation while simultaneously allowing blood flow through the gaps between spokes. Within the balloon, balloon valve leaflets 306 may be configured to allow unidirectional blood flow from the left ventricle to the aorta, minimizing regurgitation and preserving hemodynamic stability.

[0064] This central mounting configuration may provide symmetrical radial force for valve dilation while maintaining a central flow lumen, supporting both mechanical expansion and physiological circulation during the intervention.

[0065] Referring to FIG. 4A, it illustrates a perspective view of the integrated balloon system featuring a centrally mounted hollow cylinder shaped balloon supported by spoke-like connectors extending from a central shaft. The figure highlights the internal valve leaflets, annular enclosed space, fill ports, and double lumen shaft configuration.

[0066] The overall image 400A represents the structural layout of the balloon system configured for stable central deployment. The central shaft 402A may serve as the primary structural support and guiding element for the balloon, which is represented as the central shaft balloon 404A. Theballoon may be concentrically aligned with the shaft and connected via multiple spokes 414A, which may provide symmetrical support and maintain the balloon’s central positioning during deployment at the same time allowing blood to flow between spokes. Within the balloon, valve leaflets 406A may be positioned to allow one-way blood flow during systole while preventing backflow during diastole, thereby promoting physiological circulation throughout the procedure.

[0067] The annular enclosed space 408A may surround the central lumen and function as the inflatable chamber, which can be expanded by injecting fluid through fill ports 412A. These fill ports may be linked to the inflation lumen in the double lumen shaft 410A through spokes, The double lumen shaft may house separate channels — one for guidewire passage and another for inflation fluid. This configuration may provide enhanced control over balloon positioning and inflation, supporting safe and effective dilation of the stenotic aortic valve while preserving hemodynamic stability.

[0068] Referring to FIG. 4B, it illustrates a partial sectional view of the balloon system showing the integration of lithotripsy components. It depicts the internal arrangement of the central lumen, inflation lumen, lithotripsy conducting elements, and longitudinally positioned lithotripsy energy emitting elements within the annular enclosed space.

[0069] The overall image 400B presents a cross-sectional perspective that may help visualize the internal functional layout of the balloon assembly. The central lumen 402B may be configured to facilitate continuous forward blood flow during balloon inflation. The balloon may be supported structurally by a spoke 404B, which extends from the central shaft to maintain the balloon’s position and integrity.

[0070] The lithotripsy conducting element 406B may serve as a pathway for delivering energy — such as electrical or laser or any other suitable form of energy — from an external power source to the site of calcification. The inflation lumen 408B may allow fluid to be introduced into the balloon, while the fill ports 410B may provide way for the entry and exit of this fluid to expand or deflate the balloon as required, with the fluid passing from the central shaft to the annular expandable space of the balloon through the spokes. The annular enclosed space 412B surroundsthe central lumen and may house the lithotripsy energy emitting elements 414B, which are arranged longitudinally to ensure close proximity to the calcified valve leaflets or annulus. This arrangement may enhance the efficiency of calcium modification while maintaining structural balance and hemodynamic stability during the procedure.

[0071] Referring to FIG. 4C, it illustrates a front cross-sectional view of the centrally mounted integrated balloon system, showing the internal valve leaflets, central shaft, guidewire, and fluid / energy channels positioned within the annular space. The overall image is designated as 400C, representing a top-down view of the balloon system in its inflated and operational configuration. The central shaft 404C may serve as the structural and functional core of the device, extending through the balloon and accommodating the guidewire 410C, which may aid in navigation and positioning across the aortic valve. Surrounding the central shaft is a set of leaflets 408C, which may be positioned within the central lumen of the balloon and configured to function as unidirectional valves, thereby permitting forward blood flow during systole and preventing regurgitation during diastole. The annular space 406C may surround the central lumen and serve as the inflatable chamber of the balloon, exerting radial pressure against the stenotic valve upon expansion. Embedded within this annular region are channels 402C, which may be used to carry both inflation fluid and lithotripsy energy emitting elements, enabling controlled expansion of the balloon as well as targeted delivery of energy for calcium modification. This configuration may support simultaneous valvuloplasty and in-situ lithotripsy while maintaining physiological blood flow through the central lumen.

[0072] Referring to FIG. 5A, it illustrates a schematic representation of the integrated balloon system connected to a power generator for lithotripsy functionality. The figure shows the central shaft balloon mounted via spokes, with fill ports and a double lumen shaft, highlighting the electrical setup used to power and control the lithotripsy energy emitting elements integrated within the system.

[0073] The overall image 500A presents the layout of the balloon device as part of a functional system incorporating energy delivery for in-situ lithotripsy. A power generator 502A may be shown connected to the system, which may supply the required energy — such as electrical pulsesor lasers or any other suitable energy form to the lithotripsy components incorporated within the balloon. The central shaft 504A may serve as the structural and functional core of the system, allowing for guidewire passage, inflation fluid passage and transmission of lithotripsy energy conduction system.

[0074] The central shaft balloon 510A is depicted as mounted concentrically around the shaft and may be held in place by spokes 506A, which can provide mechanical support and maintain alignment. The spokes also provide a path for lithotripsy conduction system from catheter shaft to energy emitting elements in the balloon. The energy emitting elements are arranged longitudinally in the annular balloon space, connected to the lithotripsy conduction system. Additionally, the double lumen shaft 512A may include one channel for balloon inflation and another for guidewire access and additionally lithotripsy energy conduction wiring. This configuration may allow the operator to independently control balloon expansion and lithotripsy activation, providing a comprehensive solution for both mechanical dilation and targeted calcium disruption.

[0075] Referring to FIG. 5B, it illustrates a sectional view of the balloon system showing the internal structural arrangement for lithotripsy functionality. The figure depicts the spokes, lithotripsy conducting elements, inflation lumen, fill ports, and the annular enclosed space, along with longitudinally arranged lithotripsy energy emitting elements positioned for targeted calcium modification.

[0076] The overall image 500B provides a cross-sectional representation of the balloon structure, offering insight into how various internal components may be arranged to support lithotripsy during valvuloplasty procedures. The spoke 502B may structurally connect the balloon to a central shaft, providing both support and alignment for the central flow lumen. Integrated within the structure, the lithotripsy conducting element 504B may function as a conduit for transmitting electrical energy or pulses from an external power source to the therapeutic site.

[0077] The inflation lumen 506B may be used to channel contrast media or fluid into the balloon, enabling radial expansion, which is facilitated through fill ports 508B. Surrounding thecentral lumen, the annular enclosed space 51 OB may act as the inflatable chamber and simultaneously house the lithotripsy energy-emitting elements 512B, which are arranged longitudinally from proximal to distal. These energy emitting elements may be strategically positioned to ensure close proximity to the calcified aortic valve leaflets or annulus, thereby allowing effective energy delivery for calcium disruption. This integrated arrangement may allow clinicians to perform controlled and lithotripsy while maintaining balloon inflation and stable hemodynamics.

[0078] Referring to FIG. 6A, it illustrates a perspective view of the integrated balloon system configured for transcatheter aortic valve implantation (TAVI), showing the central shaft, hollow cylinder shaped balloon, mounted aortic prosthetic valve, supporting spokes, and the double lumen shaft. The overall image is denoted by 600A, depicting the arrangement of components in a centrally aligned deployment configuration. The central shaft 602A may extend vertically through the system and act as the primary structural element, providing support and alignment for the balloon and associated components. Surrounding the shaft is a balloon 604A, which may be configured in a hollow cylindrical form and adapted to expand radially to facilitate dilation of the stenosed aortic valve during the TAVI procedure.

[0079] Mounted on the balloon is an aortic prosthetic valve 606A, which may be mounted circumferentially and delivered to the implantation site along with the balloon system. The prosthetic valve may be designed to expand in coordination with the balloon inflation, allowing for secure placement at the target site. Spokes 608A may extend radially from the central shaft to the interior of the balloon structure, providing mechanical support and maintaining the central alignment of the shaft and prosthetic components during deployment. The double lumen shaft 610A may serve as a conduit for both guidewire navigation and the delivery of inflation fluid. This configuration may enable precise positioning and stable deployment of the prosthetic valve while maintaining controlled expansion and central flow during TAVI procedures.

[0080] Referring to FIG. 6B, it illustrates a cross-sectional view of the integrated balloon system with a mounted aortic prosthetic valve, showing the central lumen, central shaft, valve leaflets, balloon leaflets, surrounding annular space, and channels for fluid. The overall image isdesignated as 600B, representing the axial view of the balloon assembly during a transcatheter valve implantation procedure. At the center, the central shaft 608B may extend longitudinally through the system and function as a structural core that also provides a passageway for guidewire navigation and inflation fluid.

[0081] Surrounding the shaft is the hollow cylindrical balloon with prosthetic aortic valve mounted on it, which may be integrated into the system for deployment during balloon expansion. The prosthetic valve may be mounted in a way that allows it to unfold symmetrically when the balloon is inflated, aligning with the aortic annulus for proper placement. The annular space 606B may serve as the inflatable chamber of the balloon, capable of exerting outward radial pressure to both dilate the stenosed native valve and secure the prosthetic valve in position. Embedded within this annular space are channels 604B, which may be configured to carry inflation fluid. This hollow cylinder balloon design with internal valve leaflets for unidirectional flow of blood during balloon inflation and valve implantation may facilitate controlled and stable delivery of the prosthetic valve while preserving hemodynamic integrity during the procedure.

[0082] Referring to FIG. 7, it illustrates an exemplary procedural flow diagram for using the integrated balloon system in aortic valvuloplasty. The flow outlines the steps involved in positioning, inflating, and deflating the balloon across the stenotic aortic valve, enabling mechanical dilation while maintaining forward blood flow.

[0083] The overall flow 700 represents a sequential method that may be followed during the clinical use of the balloon system. The process may begin with introducing the guidewire 702 across the stenosed aortic valve and advancing it into the left ventricle. This guidewire may serve as a navigational aid for the catheter-based system. Once in place, the next step involves advancing the integrated balloon catheter 704 over the guidewire, allowing for controlled delivery of the device to the target site.

[0084] Upon reaching the aortic valve, the system proceeds with positioning the hollow cylindrical balloon 706 accurately across the stenotic valve. Proper alignment may be critical to ensure effective and symmetric dilation. Following positioning, the operator may connect theinflation port 708 of the balloon to a syringe or indeflator filled with diluted contrast medium, enabling pressurized delivery of fluid to the balloon’s inflation chamber.

[0085] Subsequently, inflating the annular enclosed space 710 of the balloon may initiate mechanical dilation of the stenosed valve. During this inflation process, the system is uniquely designed to allow continuous forward blood flow 712 through its central lumen, thereby preventing interruption of cardiac output. Simultaneously, the valve leaflets within the balloon 714 may function to prevent retrograde flow into the left ventricle, promoting stable and unidirectional circulation.

[0086] With the balloon in place and physiological flow preserved, the method continues by maintaining balloon inflation 716 for a clinically suitable duration without requiring rapid ventricular pacing, thus reducing procedural risks. Upon achieving sufficient dilation, the next step involves deflating the balloon 718 by aspirating the contrast through the inflation port. Finally, the operator may complete the process by retracting the balloon catheter 720 over the guidewire and removing it from the patient’s vasculature. This procedural flow may provide a hemodynamically stable approach to balloon valvuloplasty, reducing the reliance on pacing and improving safety and efficacy in patients with aortic valve stenosis.

[0087] Referring to FIG. 8, it illustrates an exemplary procedural flow diagram for using the integrated balloon system with embedded lithotripsy functionality. The flow represents the steps required to deliver focused lithotripsy pulses in conjunction with balloon dilation for effective modification of calcified aortic valve tissue.

[0088] The overall flow 800 outlines a step-by-step method that may be followed during the combined application of valvuloplasty and lithotripsy. The procedure may begin with inserting the guidewire 802 across the heavily calcified aortic valve and into the left ventricle. This step establishes a path for safely navigating the balloon catheter through the aortic anatomy. Once the guidewire is secured in position, the operator may proceed with tracking the balloon catheter 804 — which includes embedded lithotripsy energy emitting elements — over the guidewire until the target region is reached.

[0089] Following this, positioning the balloon 806 with its energy emitting elements directly at the aortic valve may ensure optimal alignment for both mechanical dilation and energy delivery. Next, the system setup is completed by connecting the inflation port and power generator 808 to the balloon catheter system. The inflation port may allow fluid-based expansion of the balloon, while the power generator may be configured to activate the lithotripsy components.

[0090] Once the setup is complete, the operator may initiate inflating the balloon 810 so that the outer surface of the annular enclosed space comes into contact with the calcified valve leaflets or annular structures. After confirming stable contact, the next step involves activating the lithotripsy system 812 to deliver precisely controlled energy pulses to the calcified tissue. These pulses modify the calcium structure 814, improving tissue compliance and enabling a more effective mechanical expansion.

[0091] To maintain treatment efficiency, the procedure may involve continuing balloon inflation 816 during the lithotripsy process. Due to the open central lumen design, blood flow may not be interrupted, supporting stable hemodynamics throughout the energy delivery phase. Upon completion of the desired calcium modification, the operator may proceed with deflating the balloon 818 by aspirating the contrast fluid through the inflation port. Finally, the system may be withdrawn safely over the guidewire 820, marking the end of the procedure. This combined lithotripsy-assisted valvuloplasty technique may enhance the success of valve dilation in cases with severe calcification while preserving physiological flow and minimizing procedural risks.

[0092] According to the non-limiting exemplary aspect of the present invention, the integrated balloon system may comprise a hollow cylindrical-shaped balloon designed for valvuloplasty and / or valvular lithotripsy. The balloon may be constructed from a compliant or non-compliant medical-grade material to accommodate varying procedural requirements. Structurally, the balloon may include a central lumen that is open at both ends and surrounded by a closed peripheral annular space. This annular enclosed space may be in fluid communication with an inflation lumen of a catheter shaft, allowing the introduction of a contrast agent or other inflation fluid to expand the balloon during use.

[0093] Upon inflation, the peripheral annular space may exert radial pressure outwardly against the stenotic aortic valve while simultaneously maintaining the central lumen open, thereby permitting forward blood flow through the balloon. This configuration may preserve hemodynamic stability during the procedure and eliminate the need for rapid pacing.

[0094] According to the non-limiting exemplary aspect of the present invention, the central lumen may also include valve-like leaflets attached to the inner luminal wall. These leaflets may facilitate unidirectional blood flow from the left ventricle (LV) to the aorta while preventing backflow during diastole. This feature may be observed in reference to FIG. 2A and FIG. 2D, where the valve leaflets (210A, 202D) are depicted functionally oriented within the central lumen.

[0095] According to the non-limiting exemplary embodiment of the present invention, the balloon may be mounted in two distinct configurations: in one embodiment, the balloon may be eccentrically attached to the distal end of a catheter shaft, as illustrated in FIG. 2A and FIG. 2B (210A, 210B). In another embodiment, the balloon may be centrally aligned and supported by spoke-like structures extending from the central catheter shaft, as shown in FIG. 3 and FIG. 4A (308, 414A).

[0096] According to another non-limiting exemplary embodiment of the present invention, the catheter shaft may be formed from a suitable biocompatible material and may include a doublelumen design. One lumen may allow for the passage of a guidewire, while the second lumen may be connected to the peripheral enclosed space of the balloon for inflation and deflation. The proximal end of the inflation lumen may terminate in a side port (e.g., 204A, 508A), which may be interfaced with a syringe or indeflator containing diluted contrast or similar media for balloon expansion. The shaft also serves as conduit for lithotripsy energy conduction system from power source to energy emitting points in the balloon.

[0097] According to the non-limiting exemplary aspect of the present invention, the balloon system may be used for aortic valvuloplasty, including pre-dilatation or post-dilatation duringTranscatheter Aortic Valve Implantation (TAVI). In this use case, the balloon may be passed over a guidewire that has already crossed the aortic valve and is positioned within the LV. Upon proper positioning, the balloon may be inflated with contrast to exert therapeutic pressure against the stenotic valve without obstructing forward blood flow. Because of its open central lumen and valve leaflet configuration, the system may allow sustained inflation without requiring high-rate pacing to maintain position or prevent hemodynamic collapse.

[0098] According to the non-limiting exemplary aspects of the present invention, the same balloon may also be used for transcatheter aortic valve implantation (TAVI) by mounting a prosthetic valve onto the balloon. When the balloon is inflated in the desired aortic position, the prosthetic valve may be expanded and implanted securely at the target site. The balloon may be kept inflated for a prolonged duration to ensure proper positioning and deployment of the valve. Since the balloon is designed with a central lumen that allows continuous blood flow from the left ventricle (LV) to the aorta, the inflation does not obstruct forward flow and hence may not cause hemodynamic compromise during valve implantation.

[0099] According to another non-limiting exemplary embodiment of the present invention, the same eccentrically or centrally mounted hollow cylindrical balloon may further incorporate a valvular lithotripsy mechanism. This may involve enabling a series of circumferentially spaced energy emitting elements or optical fibers within the balloon’s peripheral annular space wall, as shown in FIG. 2E, FIG. 4B, and FIG. 5B (206E, 414B, 512B). These energy emitting elements may be connected to a power generator (e.g., 502A in FIG. 5A) via conducting elements (406B, 504B), and may emit focused electrical or acoustic pulses for calcium modification. Once the balloon is inflated across the calcified aortic valve, these impulses may be delivered to fracture or soften the calcific deposits, improving balloon efficacy and prosthetic valve expansion.

[0100] According to the non-limiting exemplary aspects of the present invention, the peripheral annular space may house a series of lithotripsy energy emitting elements, which may be strategically positioned to he in close proximity to the valvular and annular calcium deposits. This spatial arrangement may enable focused energy delivery directly to the calcified structures,thereby leading to effective calcium modification and improved procedural outcomes during valvuloplasty or transcatheter valve implantation.

[0101] The system may be kept inflated for a suitable duration to allow for complete delivery of lithotripsy pulses without causing obstruction to forward flow. After the completion of balloon dilation and / or lithotripsy, the contrast medium may be aspirated, deflating the balloon, which may then be withdrawn over the guidewire. This integrated configuration, offering both mechanical dilation and calcium modification within a hemodynamically stable design, may provide a significant improvement over conventional balloon valvuloplasty systems.

[0102] According to the non-limiting exemplary aspects of the present invention, the balloon may be cylindrical in shape and not tapered at either end, thereby allowing unobstructed flow of blood through the central lumen during inflation. This geometric configuration may be particularly advantageous for maintaining continuous forward cardiac output throughout the procedure, minimizing the risk of hemodynamic instability. Furthermore, the balloon material may be selected from compliant, semi-compliant, or any other suitable biocompatible materials, depending on the desired expansion characteristics and procedural requirements.

[0103] The description provided herein does not limit the use of this balloon design to the specified context alone; it may also be applicable in other clinical scenarios involving different valves, such as the mitral or pulmonary valve, or in critical intravascular sites where continuous forward blood flow is essential — for example, in cases of calcified stenosis of the left main coronary artery requiring lithotripsy-assisted angioplasty.

[0104] Reference throughout this specification to “one embodiment”, “an embodiment”, or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, appearances of the phrases “in one embodiment”, “in an embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0105] Although the present disclosure has been described in terms of certain preferred embodiments and illustrations thereof, other embodiments and modifications to preferred embodiments may be possible that are within the principles and spirit of the invention. The above descriptions and figures are therefore to be regarded as illustrative and not restrictive.

[0106] Thus the scope of the present disclosure is defined by the appended claims and includes both combinations and sub-combinations of the various features described hereinabove as well as variations and modifications thereof, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

CLAIMSWe Claim:

1. An integrated balloon system for hemodynamically stable valvuloplasty and in-situ lithotripsy comprising:a hollow cylindrical balloon having a central lumen open at both ends and an annular enclosed space surrounding the central lumen, wherein the annular enclosed space is configured to receive inflation fluid via a catheter-connected inflation lumen to expand the balloon and exert radial force on a stenotic aortic valve, and wherein the central lumen includes valve-like leaflets attached to its inner surface to permit unidirectional flow of blood from the left ventricle to the aorta and prevent regurgitation, thereby maintaining forward cardiac output and hemodynamic integrity and stability during balloon inflation;a catheter shaft comprising a double-lumen structure with a first lumen for receiving a guidewire and a second lumen in fluid communication with the balloon’s annular space for contrast delivery and aspiration;a plurality of lithotripsy energy emitting elements placed circumferentially within the annular balloon space and configured to be in close proximity to the calcified valve or annular tissue upon inflation;a power generator operably connected to the energy emitting elements via conducting elements extending through or along the catheter shaft, whereby the energy emitting elements are adapted to deliver controlled energy pulses to disrupt calcific deposits, thereby enabling effective dilation of the aortic valve while preserving hemodynamic stability and eliminating the need for rapid ventricular pacing.

2. The system of claim 1, wherein the valve-like leaflets within the central lumen are integrally formed or attached to the balloon’s inner surface and are configured to open during systole and close during diastole.

3. The system of claim 1, wherein the balloon is eccentrically mounted to the catheter shaft to allow free flow of blood through the central lumen.

4. The system of claim 1, wherein the balloon is centrally mounted around the catheter shaft via a plurality of spoke-like support structures extending radially between the shaft and annular inflatable enclosed space of the balloon.

5. The system of claim 1, wherein the catheter shaft and the balloon are operably connected via a plurality of spokes, the spokes being configured to serve as conduits for the passage of inflation fluid from the inflation lumen and conduction material for lithotripsy energy delivery to the annular space of the balloon.

6. The system of claim 1, wherein the lithotripsy energy emitting elements are arranged in a circular manner circumferentially within the annular enclosed space in eccentrically mounted balloon to ensure uniform and close proximity to calcified valve tissue during inflation.

7. The system of claim 1, wherein lithotripsy energy emitting elements are arranged in longitudinal manner circumferentially in the balloon annular space in the centrally mounted hollow cylinder balloon.

8. The system of claim 1, wherein the system is configured for use in pre-dilatation or post-dilatation during transcatheter aortic valve implantation (TAVI) or aortic valvuloplasty for as much duration as required without hemodynamic compromise.

9. The system of claim 1, wherein the balloon is configured to remain inflated for a prolonged duration while maintaining forward blood flow through the central lumen, thereby enabling extended lithotripsy or dilation without hemodynamic compromise.

10. The system of claim 1, wherein the balloon is further configured for use in Transcatheter Aortic Valve Implantation (TAVI) by mounting the valve on the balloon and inflating the balloon at a target site for a suitable duration to secure the valve during implantation without hemodynamic compromise.

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