System and method for guided balloon therapy with pressure-volume monitoring and automated therapeutic delivery

Abstract

A system for guided balloon therapy in interventional cardiology is provided, configured to insert and operate an inflatable balloon (10) within a blood vessel of a patient. The system comprises means for measuring pressure and volume of the balloon in real time during inflation. A main piston (110) is configured to move liquid from a first liquid reservoir (115) to the balloon, inject liquid into the balloon via a catheter (155), and control inflation based on measured pressure-volume characteristics to optimize vessel compliance. A second piston (120) is configured to move liquid from a second liquid reservoir (125) to the balloon and deliver therapeutic interventions in response to deviations in the pressure-volume relationship. This enables precise, real-time control of balloon inflation and targeted therapy delivery, improving procedural accuracy and therapeutic outcomes.

Description

[0001] Title: System and Method for Guided Balloon Therapy with Pressure-Volume Monitoring and Automated Therapeutic Delivery

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to systems and methods for guided balloon therapy. The prevent disclosure also relates to a special connector.

[0004] BACKGROUND

[0005] Coronary artery disease remains one of the leading causes of morbidity and mortality globally, with over 5 million patients undergoing interventions annually. Among the available treatment options, Percutaneous Coronary Intervention (PCI) has gained widespread acceptance due to its minimally invasive approach. However, the management of calcified lesions, a common complication in up to 25% of PCI cases, continues to present significant challenges. These calcifications, located in the arterial media or around the adventitia, reduce vessel compliance and impede stent expansion, leading to complications such as target lesion failure, under-expansion, and mal-apposition.

[0006] The indeflator, also known as a balloon inflator / deflator device, is a critical tool in interventional cardiology procedures such as angioplasty. This device is designed to precisely control the inflation and deflation of balloon catheters used to dilate stenotic or blocked arteries. Typically equipped with a pressure gauge, the indeflator allows clinicians to monitor and adjust the pressure applied to the balloon, often measured in atmospheres (atm), ensuring optimal vessel expansion while minimizing the risk of complications. Modern indeflators are lightweight and ergonomically designed to facilitate ease of use during complex procedures. However, traditional indeflators often rely solely on pressure readings and lack the ability to monitor volume changes. This approach introduces significant limitations:

[0007] • Operators often work with pressure only and ignore the volume of fluid injected into the balloon, limiting the ability to detect obstacles or calcifications during inflation. • Balloons may be compliant or non-compliant, and their behavior varies significantly under different conditions.

[0008] • The tactile feedback required to discern calcified regions is often missing in modern systems, especially when operating remotely.Air bubbles within the balloon create false pressure readings, increasing the risk of complications such as embolism or under-expansion of the stent.

[0009] Several existing systems and methods have attempted to address these challenges; however, they remain limited in scope:

[0010] W02023039310A1: Describes an angioplasty system with pre-programmed inflation profiles and drug-coated balloons.

[0011] W02023039309A1 / EP4398967A1: Focuses on pressure pulse.

[0012] WO 2025 / 016782 Al describes an inflation device for an intravascular balloon catheter comprising pressure sensing and processing means configured to determine balloon compliance and to provide a visual representation of compliance data.

[0013] US 2023 / 0106928 Al describes systems and methods for localized drug delivery using drug-coated balloons, including balloon structures capable of generating controlled oscillatory movement to influence drug release characteristics.

[0014] US 2021 / 0008354 Al describes a medical device including a balloon catheter provided with an internal mechanical spring structure configured to generate pressure impulses within the balloon fluid.

[0015] WO 01 / 010491 A2 describes a method and device for operating a balloon dilation catheter in which the balloon is subjected to oscillatory pressure supplied by a pressure generator in order to achieve less invasive dilation.

[0016] CN 116570824 A describes a balloon-related medical device including structural features for therapeutic application.

[0017] Existing PCI strategies involve a range of heterogeneous techniques, including high-pressure dilatation, cutting or scoring balloons, atherectomy devices, and shockwave therapy. While these methods have shown efficacy in certain cases, they remain limited in scope and are dependent on operator expertise. Shockwave therapy, for example, uses piezoelectric elements embedded in balloons to generate shockwaves that fracture calcifications. However, this approach is costly, lacks real-time feedback, and requires devicespecific setups, making it inaccessible for widespread use.There is a clear need for a method and system that provides guided therapy with real-time feedback, addressing the limitations of current systems and offering a universal solution adaptable to various balloon types and clinical scenarios.

[0018] SUMMARY

[0019] In order to overcome the problems of the prior art, there is provided a system for guided balloon therapy in interventional cardiology, configured to insert and operate an inflatable balloon within a blood vessel of a patient, the system comprising:

[0020] o means to measure the pressure and volume of the balloon in real time during balloon inflation,

[0021] o a main piston configured to:

[0022] ■ move liquid from a first liquid reservoir to the inflatable balloon, ■ inject liquid into the inflatable balloon through a catheter locked in a Colibri Connector, and

[0023] ■ inflate the balloon to its optimal size based on the measured pressurevolume (P / V) characteristics, ensuring precise vessel compliance and preparation;

[0024] o a second piston configured to move liquid from a second liquid reservoir to the inflatable balloon and to deliver therapeutic interventions based on detected deviations in pressure-volume relationships.

[0025] This has the benefit that the system enables precise inflation of the balloon while continuously monitoring pressure and volume, allowing real-time adjustments to optimize vessel compliance and ensure effective treatment.

[0026] Preferably, the system further comprises a purge piston configured to move liquid from a third liquid reservoir to the inflatable balloon and to purge residual air from the inflatable balloon, directing purged air and liquid back to the third liquid reservoir.

[0027] This has the benefit that removing residual air ensures accurate pressure-volume readings and minimizes the risk of embolism, enhancing procedural safety.

[0028] Advantageously, the Colibri Connector comprises a coaxial Luer lock system, including an outer (or inner) lumen configured for liquid delivery to the inflatable balloon andan inner (or outer) lumen configured for air aspiration from the inflatable balloon. The outer (or inner) lumen is fluidly connected to the first and second liquid reservoirs, and the inner (or outer) lumen is fluidly connected to the third liquid reservoir.

[0029] This has the benefit that the coaxial Luer lock system facilitates simultaneous air aspiration and liquid delivery, ensuring efficient debubbling and optimal balloon compliance.

[0030] Even more preferably, the second liquid reservoir and the first liquid reservoir are the same.

[0031] This has the benefit that reducing the number of reservoirs simplifies the system while maintaining functionality.

[0032] Preferably, the system further comprises a fourth liquid reservoir connected to at least one of the first, second, and third liquid reservoirs.

[0033] This has the benefit that the fourth reservoir provides additional fluid capacity, enabling extended therapeutic delivery or backup fluid supply.

[0034] It is an advantage that the main piston, the second piston, and the first and second liquid reservoirs are provided by a manual indeflator.

[0035] This has the benefit that the manual indeflator allows precise control over inflation and therapy applications without requiring a robotic system, making it suitable for various clinical settings.

[0036] Preferably, the second piston is inserted inside the main piston.

[0037] This has the benefit that a nested piston configuration reduces the overall footprint of the system while enabling integrated therapeutic delivery.

[0038] Advantageously, the second piston is further connected to a spring configured to store mechanical energy, wherein the spring is compressed during the piston's movement and subsequently released to generate pressure waves, enabling the delivery of therapeutic interventions such as shockwaves or pulsatile fluid delivery to the inflatable balloon.

[0039] This has the benefit that the spring-loaded mechanism provides controlled shockwave delivery, enhancing calcification treatment without requiring additional external energy sources.Even more preferably, the second piston is configured to generate acoustic waves by creating rapid oscillations or vibrations through controlled mechanical or hydraulic movements, enabling targeted therapeutic interventions within the inflatable balloon.

[0040] This has the benefit that acoustic wave therapy allows for non-invasive vessel compliance modulation and improved therapeutic efficacy.

[0041] Preferably, the second piston further comprises a toothed gear mechanism configured to:

[0042] • gradually store mechanical energy through engagement of interlocking teeth, and • suddenly disengage to produce a controlled impulse for generating therapeutic shockwaves.

[0043] This has the benefit that the controlled gear mechanism ensures precise energy release for shockwave therapy, improving lesion modification and vessel preparation.

[0044] The system further comprises a processor configured to receive the pressure and volume measurements in real time.

[0045] This has the benefit that real-time data acquisition allows automated adjustments to optimize inflation and therapy delivery.

[0046] Advantageously, the system further comprises a display to show the pressure and volume measurements.

[0047] This has the benefit that a real-time display provides immediate feedback to the operator, enhancing procedural control and reducing the risk of overinflation.

[0048] Even more preferably, the main piston, second piston, and purge piston are provided by a robotic system, wherein the robotic system is configured to operatively connect to a disposable cassette comprising the first, second, and third liquid reservoirs. The robotic system further comprises a robotic unit comprising piston actuators configured to engage with the pistons reservoirs within the cassette, enabling automated activation of the liquid reservoirs for controlled fluid delivery, therapeutic interventions, and air purging.

[0049] This has the benefit that automation reduces manual variability, ensuring reproducible procedures and enhancing operator efficiency.

[0050] It is an advantage that the processor is configured to:• monitor and analyze real-time pressure-volume (P / V) curves,

[0051] • control fluid delivery, therapeutic interventions, and air purging dynamically based on deviations or specific patterns in the P / V curves, and

[0052] • adaptively adjust inflation sequences based on vessel compliance.

[0053] This has the benefit that adaptive control improves treatment precision, allowing real-time adjustments based on vessel characteristics.

[0054] Preferably, the robotic system comprises an automated calibration function to adjust piston actuation profiles based on detected variations in catheter resistance.

[0055] This has the benefit that automated calibration optimizes inflation pressure, reducing the risk of vessel trauma.

[0056] Advantageously, the system further comprises a display unit configured to visually present real-time pressure-volume (P / V) curves, providing actionable feedback for vessel preparation and therapeutic intervention.

[0057] This has the benefit that visual representation of P / V curves allows clinicians to optimize treatment strategies and detect vessel abnormalities.

[0058] Even more preferably, the system further comprises a handheld controller configured to:

[0059] • manually control the main piston for liquid delivery, and

[0060] • activate the second piston to deliver therapeutic interventions such as shockwaves or drug delivery.

[0061] This has the benefit that the handheld controller provides a user-friendly interface for manual operation, ensuring procedural flexibility.

[0062] Preferably, the handheld controller further comprises tactile feedback, the feedback being indicative of at least one of:

[0063] resistance encountered during balloon inflation,

[0064] detection of calcified lesions based on deviations in P / V curves, and

[0065] operator alerts for critical adjustments.This has the benefit that tactile feedback enhances procedural awareness, allowing for precise control over inflation and therapy delivery.

[0066] It is an advantage that the system further comprises a second purge mechanism, the second purge piston operating in coordination with the first purge piston to:

[0067] • maintain a neutral system volume, and

[0068] • generate controlled pressure waves, ensuring optimized therapeutic energy transfer.

[0069] This has the benefit that volume-neutral operation prevents unintended pressure fluctuations while enabling effective shockwave therapy.

[0070] Preferably, the first liquid reservoir comprises a cavitation zone, wherein the cavitation zone is a narrowed region that accelerates fluid flow, generating cavitation bubbles that collapse to produce localized mechanical stress for lesion treatment.

[0071] This has the benefit that the cavitation mechanism enhances vessel preparation by breaking down calcifications.

[0072] Advantageously, the system further comprises an identification module configured to detect and retrieve parameters of the inflatable balloon, wherein the identification module comprises at least one of:

[0073] • An RFID reader,

[0074] • A QR code scanner, or

[0075] • An optical recognition system.

[0076] This has the benefit that automatic balloon identification ensures optimized inflation pressure and compliance settings, reducing procedural errors.

[0077] There is further provided a Colibri Connector configured to integrate with the system, wherein the Colibri Connector comprises:

[0078] • a coaxial Luer lock system,

[0079] • an outer lumen (or inner lumen) for liquid delivery and an inner lumen (or outer lumen) for air aspiration, and

[0080] • a sealed design, enabling simultaneous liquid delivery and air aspiration without leakage.This has the benefit that the sealed design prevents leakage while facilitating efficient fluid exchange.

[0081] Preferably, the Colibri Connector further comprises an adaptive-length mechanism, ensuring secure engagement with varying catheter geometries.

[0082] This has the benefit that the adaptive mechanism allows compatibility with multiple catheter designs.

[0083] Even more preferably, the Colibri Connector comprises a solid-core shaft mechanism, configured to:

[0084] • facilitate precise fluid displacement within the balloon, and

[0085] • transmit vibratory energy for shockwave therapy or calcification treatment.

[0086] This has the benefit that the solid-core shaft enhances precision and therapeutic effectiveness.

[0087] Preferably, there is provided a manual indeflator for controlled inflation and therapeutic intervention in an inflatable balloon within a blood vessel, wherein the manual indeflator comprises:

[0088] • a main piston configured to move liquid from a first liquid reservoir to the inflatable balloon via a catheter,

[0089] • a second piston positioned within the main piston, configured to generate therapeutic interventions in the form of pressure waves, shockwaves, or acoustic waves,

[0090] • a trigger mechanism configured to control the actuation of the main piston and the second piston, allowing precise fluid delivery and therapy application,

[0091] • a turning knob connected to a gearbox and a rotary encoder, wherein rotation of the knob actuates the main piston via a rack-and-pinion mechanism, ensuring controlled displacement of liquid,

[0092] • a linear encoder configured to measure the absolute volume of fluid delivered based on piston displacement,

[0093] • a pressure sensor integrated within the fluid pathway, configured to continuously monitor real-time pressure variations and provide feedback for therapeutic interventions, anda wireless communication module integrated within the handle, configured to transmit real-time pressure-volume data to an external display unit for procedural monitoring and operator feedback.

[0094] Advantageously, there is provided a disposable cassette for use with a robotic system for balloon inflation and therapy delivery, wherein the cassette comprises:

[0095] • a first liquid reservoir for supplying inflation fluid,

[0096] • a second liquid reservoir for storing therapeutic agents,

[0097] • a third liquid reservoir for air removal and recirculation,

[0098] • a fluid interface configured to connect to a Colibri Connector for bidirectional fluid management, and

[0099] • a piston interface area configured to engage with robotic actuators, allowing for precise control of piston movements within the cassette.

[0100] Even more preferably, there is provided a robotic system for automated inflation, therapeutic intervention, and air removal, wherein the system comprises:

[0101] • a processor configured to monitor and analyze real-time pressure-volume curves, control fluid delivery and therapeutic interventions dynamically, and adjust inflation sequences automatically,

[0102] • a display unit configured to present real-time procedural data,

[0103] • a plurality of piston actuators configured to engage with a disposable cassette, enabling automated fluid management,

[0104] • a handheld controller for manual activation of pistons and therapeutic delivery, • a wireless communication module configured to transmit real-time procedural data to external monitoring systems.

[0105] This system enhances procedural efficiency, ensures consistent fluid delivery, and optimizes therapeutic interventions while allowing for both manual and automated operation.

[0106] Key features include:

[0107] 1. Pressure-Volume Monitoring: Continuous tracking of P / V curves to detect calcifications and guide therapy.2. Colibri Connector: A coaxial luer lock system with an inner tube for air removal, ensuring accurate and consistent balloon preparation.

[0108] 3. Guided Shockwave Therapy: Utilizes water column cavitation to deliver tailored shockwaves based on real-time P / V feedback.

[0109] 4. Automation and Compatibility: A robotic system with universal compatibility, supporting all balloon types and reducing reliance on operator expertise.

[0110] Advantages of the Invention

[0111] 1. Real-Time Feedback: Provides continuous monitoring of P / V curves, enabling guided therapy and improved procedural precision.

[0112] 2. Automation: Eliminates manual errors in balloon preparation and therapy delivery. 3. Compatibility: Supports all balloon types and manufacturers, reducing costs and increasing utility.

[0113] 4. Safety: Removes air bubbles and minimizes the risk of embolism or arterial damage.

[0114] 5. Efficacy: Enhances lesion preparation and stent deployment outcomes, particularly in calcified lesions.

[0115] 6. Cost Efficiency: Reduces reliance on specialized tools, lowering overall procedural expenses.

[0116] Further benefits and advantages of the present invention will become apparent after a careful reading of the detailed description with appropriate reference to the accompanying drawings.

[0117] BRIEF DESCRIPTION OF DRAWINGS

[0118] These and other features, aspects, and advantages of the apparatus, systems and methods of the present disclosure will become better understood from the following description, appended claims, and accompanying drawing wherein:

[0119] Figure 1 shows a system for guided balloon therapy, illustrating the integration of multiple pistons, liquid reservoirs, and a Colibri Connector for real-time pressure-volume (P / V) monitoring, inflation control, and therapeutic delivery.Figure 2 shows a detailed view of the Colibri Connector, showing its coaxial duallumen structure and functionality in air aspiration and liquid injection.

[0120] Figure 3 shows an embodiment of a manual indeflator configured with a spring-loaded therapy piston for pulsatile shockwave therapy.

[0121] Figure 4 shows an alternative embodiment of the manual indeflator, utilizing a therapy piston that generates acoustic waves instead of mechanical shockwaves.

[0122] Figure 5 illustrates an improved manual indeflator design incorporating real-time pressure and volume monitoring, along with an integrated wireless communication module.

[0123] Figure 6 illustrates additional views of the manual indeflator with electronic components, including the activation button, rotary encoder, wireless communication module, battery bay, connector plate, linear encoder, and fluid-contact pressure sensor.

[0124] Figure 7 illustrates the manual indeflator integrated within an operating room system, showcasing real-time data transmission to an external display unit.

[0125] Figure 8 illustrates the mechanically-actuated therapy piston, including a spring mechanism, half-tooth gear engagement, and shockwave generation process.

[0126] Figure 9 is a close-up view of the half-tooth mechanism regulating controlled energy release for manual shockwave therapy.

[0127] Figure 10 shows an embodiment of the manual indeflator featuring a cavitation zone, purge chamber, and bidirectional fluid exchange for improved air removal and therapeutic control.

[0128] Figure 11 illustrates the robotic system, illustrating a cassette-based fluid management system for automated inflation, air purging, and therapy delivery.

[0129] Figure 12 illustrates an embodiment of the robotic system comprising a disposable cassette configured to be operatively connected to a robotic unit.

[0130] Figure 13 illustrates a manual inflation module comprising an inclined purge piston arranged within a cylindrical chamber for automatic air evacuation and reproducible initial liquid volume control.Figure 14 illustrates the manual inflation module of Figure 13 further comprising an ergonomic handle configured to promote a substantially vertical operating orientation during use.

[0131] Figure 15 shows an embodiment of a manual indeflator configured with a spring-loaded therapy piston for pulsatile shockwave therapy.

[0132] DESCRIPTION OF EMBODIMENTS

[0133] Terminology used for describing particular embodiments is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "and / or" includes any and all combinations of one or more of the associated listed items. It will be understood that the terms "comprises" and / or "comprising" specify the presence of stated features but do not preclude the presence or addition of one or more other features. It will be further understood that when a particular step of a method is referred to as subsequent to another step, it can directly follow said other step or one or more intermediate steps may be carried out before carrying out the particular step, unless specified otherwise. Likewise it will be understood that when a connection between structures or components is described, this connection may be established directly or through intermediate structures or components unless specified otherwise.

[0134] The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims. The drawings described are only schematic and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn on scale for illustrative purposes. Where the term "comprising" is used in the present description and claims, it does not exclude other elements or steps.

[0135] Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.The terms "about" or "approximate" and the like are synonymous and are used to indicate that the value modified by the term has an understood range associated with it, where the range can be +20%, +15%, +10%, +5%, or +1%. The term "substantially" is used to indicate that a result (e.g., measurement value) is close to a targeted value, where close can mean, for example, the result is within 80% of the value, within 90% of the value, within 95% of the value, or within 99% of the value.

[0136] Guided Balloon Therapy System

[0137] The guided balloon therapy system is a novel interventional cardiology system designed to precisely control the inflation of an inflatable balloon while simultaneously monitoring realtime pressure-volume (P / V) relationships. It enables vessel compliance modulation, calcification treatment, and optimized therapeutic delivery through advanced fluid control mechanisms and automated therapeutic interventions.

[0138] Main Piston

[0139] The main piston is the primary fluid displacement component of the system, responsible for moving liquid from a designated liquid reservoir into the balloon catheter. It ensures controlled inflation while enabling real-time volume monitoring to provide accurate feedback on balloon expansion and vessel compliance.

[0140] Therapy Piston

[0141] The therapy piston is a secondary piston which can be positioned within the main piston or separately, configured to generate therapeutic pressure waves. It can operate using various mechanisms, including a spring-loaded pulsatile therapy system for shockwave generation or controlled oscillations to produce acoustic waves for resonance-based therapy.

[0142] Purge Piston

[0143] The purge piston is dedicated to removing residual air from the system before balloon inflation, ensuring consistent and reproducible balloon preparation. By eliminating air pockets, it enhances the accuracy of pressure-volume measurements and prevents procedural complications associated with trapped air.

[0144] Liquid Reservoirs

[0145] The system includes multiple liquid reservoirs for managing different fluid functions. The first reservoir supplies inflation fluid to the main piston, the second reservoir stores therapeutic agents or additional liquid, and the third reservoir is dedicated to air removal and recirculation.An optional fourth reservoir may serve as a backup fluid supply or additional therapeutic agent storage.

[0146] Colibri Connector

[0147] The Colibri Connector is a coaxial luer lock system specifically designed for automated balloon preparation in interventional cardiology. It features an inner tube that allows simultaneous fluid injection and air aspiration, ensuring thorough removal of residual air bubbles from the balloon. Its adaptive-length mechanism ensures compatibility with various catheter designs, optimizing procedural reproducibility.

[0148] Pressure-Volume (P / V) Monitoring

[0149] The system incorporates real-time pressure-volume monitoring, continuously tracking both pressure and volume within the inflatable balloon. This enables the detection of calcified lesions, adaptive inflation sequences, and dynamic therapeutic adjustments to enhance treatment precision.

[0150] Cavitation Zone

[0151] The cavitation zone is a narrowed section within the first chamber that accelerates fluid flow, generating cavitation bubbles. These bubbles collapse to induce localized mechanical stress, improving vessel compliance modulation and enhancing shockwave-based therapy.

[0152] Automated Air Removal and Debubbling

[0153] The system integrates a fully automated air-removal mechanism that eliminates residual air between therapy applications. The Colibri Connector working with the purge piston facilitates bidirectional aspiration, preventing trapped air from interfering with pressure-volume measurements or therapeutic delivery.

[0154] Resonance-Based Therapy

[0155] Resonance-based therapy is a therapeutic approach that leverages controlled piston movements to generate standing pressure waves within the balloon. This enhances vessel compliance modulation and calcification treatment without requiring significant fluid displacement.

[0156] Wireless Communication Module

[0157] The wireless communication module is an integrated component within the manual or robotic indeflator, enabling real-time data transmission to an external display. It allows continuousprocedural monitoring, providing the operator with live feedback on pressure-volume curves and system performance.

[0158] Handheld Controller

[0159] The handheld controller serves as an interface for manual or hybrid or fully robotic control of the robotic system. It allows for manual activation of inflation and therapy pistons, provides tactile feedback to detect vessel resistance, and integrates with real-time P / V monitoring for enhanced procedural accuracy.

[0160] Robotic System with Prefilled Cassette

[0161] The robotic system automates balloon inflation, therapeutic delivery, and air purging through a sterile, prefilled cassette. It features processor-controlled piston actuation for dynamic therapy adjustments and is connected to a display unit for real-time procedural visualization.

[0162] Second Purge Mechanism

[0163] The second purge mechanism is an additional purge system designed to maintain a neutral system volume while generating controlled pressure waves. This allows for volume-stable shockwave therapy without significant fluid displacement, ensuring enhanced air-removal efficiency and improved therapeutic outcomes.

[0164] Solid-Core Shaft Mechanism

[0165] The solid-core shaft mechanism is an optional feature that enables targeted fluid displacement within the balloon system. It also facilitates the transmission of vibratory energy for calcification treatment and enhances precision in pressure wave modulation.

[0166] Hybrid Operation Mode

[0167] The hybrid operation mode allows the system to function in three configurations: manual mode for operator-controlled inflation and therapy, automated mode for processor-driven piston actuation based on real-time P / V curves, and hybrid mode, combining automated monitoring with manual therapeutic interventions.

[0168] Balloon Identification System

[0169] The balloon identification system is an automated detection mechanism that identifies the specific type of balloon being used. It optimizes inflation pressure, compliance settings, and therapeutic parameters using RFID tags, QR code scanners, or optical recognition technology.

[0170] Display Unit

[0171] The display unit provides real-time monitoring of pressure-volume curves, inflation pressure,and therapeutic interventions. It offers procedural feedback to the operator, enabling precise adjustments during balloon inflation and therapy.

[0172] Half-Tooth Gear Mechanism

[0173] The half-tooth gear mechanism is a mechanically-actuated system that enables controlled energy release for manual shockwave therapy. It allows adjustable amplitude modulation for tailored therapeutic intensity and ensures consistent and repeatable energy delivery across multiple applications.

[0174] Prefilled Cassette-Based System

[0175] The prefilled cassette-based system is a disposable, sterile unit that houses liquid reservoirs and pistons. It is designed for seamless robotic integration, enabling reproducible and contamination-free fluid management in single-use applications.

[0176] Adaptive-Length Colibri Connector

[0177] The adaptive-length Colibri Connector features a spring-loaded extension mechanism that ensures a secure and fluid-tight engagement with varying catheter designs. This feature optimizes procedural reproducibility by eliminating variability in catheter connections.

[0178] Acoustic Therapy

[0179] The system utilizes an oscillating therapy piston to generate acoustic pressure waves with the therapy piston. This enables vessel compliance modulation and enhances calcification treatment through resonance-based energy transmission.

[0180] Tactile Feedback System

[0181] The tactile feedback system is an operator-alert mechanism within the handheld controller that provides real-time sensory feedback. It detects balloon inflation resistance, calcified lesion presence, and therapy effectiveness, assisting the operator in adjusting therapeutic parameters.

[0182] Coaxial Tubing

[0183] Coaxial tubing is a fluid conduit that connects the cassette or the fluid reservoirs to the Colibri Connector. It consists of an inner lumen directly connected to the third reservoir for air aspiration and an external lumen connected to the first chamber for precise liquid delivery. The functions of the inner and external lumen can be reversed as well.

[0184] The invention is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. In the drawings,the absolute and relative sizes of systems, components, layers, and regions may be exaggerated for clarity. Embodiments may be described with reference to schematic and / or cross-section illustrations of possibly idealized embodiments and intermediate structures of the invention. In the description and drawings, like numbers refer to like elements throughout. Relative terms as well as derivatives thereof should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the system be constructed or operated in a particular orientation unless stated otherwise.

[0185] As mentioned above, standard angioplasty systems primarily measure inflation pressure but do not account for volume dynamics, resulting in a lack of direct feedback on vessel compliance, calcification resistance, or balloon expansion efficiency.

[0186] A key challenge arises in cases involving calcified or non-compliant lesions, where the balloon may reach its target pressure yet fail to expand symmetrically or effectively dilate the vessel. Without continuous monitoring of both pressure and volume, operators are unable to detect whether the balloon is fully expanding, encountering resistance, or behaving unpredictably within the artery. This limitation can lead to suboptimal vessel preparation, inadequate lesion modification, or even excessive pressure application, increasing the risk of vessel injury.

[0187] To address these challenges, the present invention introduces a novel system for guided balloon therapy in interventional cardiology.

[0188] Figure 1 illustrates a system for guided balloon therapy in interventional cardiology 100, which is configured to insert and operate an inflatable balloon 10 within a blood vessel of a patient. The system is designed to precisely control balloon inflation and therapeutic delivery using multiple pistons and fluid reservoirs.

[0189] The system integrates real-time pressure-volume (P / V) curve monitoring by providing means to measure the pressure and volume of the balloon in real time during balloon inflation, ensuring optimal vessel compliance and preparation. These means will be explained in further details below.

[0190] Unlike conventional systems that rely solely on pressure readings, the proposed system tracks both pressure and volume simultaneously, in order to allow precise assessment of the behavior of a balloon within the vessel of a patient. By continuously monitoring P / Vcharacteristics, the system can detect calcified lesions, optimize inflation sequences, and dynamically adjust therapeutic interventions, which comprise controlled shockwave impulses or drug delivery.

[0191] A main piston 110 is provided to move liquid from a first liquid reservoir 115 to the inflatable balloon 10 via a first connector 166 and a catheter 155, which can be secured in place using a Colibri Connector 150 (described further below). The main piston 110 is configured to inject liquid into the balloon and dynamically control inflation based on measured pressure-volume (P / V) characteristics, using the means to measure the pressure and volume of the balloon. A pressure sensor 1250 can be provided inside the first liquid reservoir 115 to measure the pressure in real time.

[0192] A second piston 120 is arranged to move liquid from a second liquid reservoir 125 to the inflatable balloon 10, delivering therapeutic interventions in response to deviations in pressure-volume relationships. This functionality enables precise vessel treatment, such as drug delivery or shockwave therapy, when necessary. The second piston is usually smaller in size and can share the same liquid reservoir as the main piston, as illustrated in Figure 1. These interventions are initiated either automatically, based on deviations in the P / V curve, or manually by the operator. This capability ensures targeted therapy to address calcifications or other obstacles in real time.

[0193] The system may also provide a purge mechanism to eliminate residual air from the balloon before inflation, ensuring consistent and reproducible vessel preparation.

[0194] Additionally, the system's Colibri Connector, a coaxial Luer lock interface, facilitates precise fluid management, bidirectional aspiration, and compatibility with various balloon catheters. The Colibri Connector is optional, but needs to be used when the system is to perform purging, as described further below.

[0195] A purge piston 130 is thus provided to move liquid from a third liquid reservoir 135 and is responsible for purging the air of the balloon during inflation. The purge piston 130 ensures that residual air is removed from the balloon and directs the purged air and liquid back into the third liquid reservoir 135, maintaining a fluid-tight and air-free system.

[0196] The Colibri Connector 150 is illustrated as a coaxial Luer lock system 152, which facilitates efficient liquid delivery and air removal. The Colibri Connector 150 can fluidly connect to:An outer (or inner) lumen 156 configured for liquid delivery to the inflatable balloon 10.

[0197] • An inner (or outer) lumen 158 configured for continuous air aspiration from the balloon.

[0198] • Fluid connections between the outer (or inner) lumen 156 and the first and second liquid reservoirs 115, 125, and between the inner (or outer) lumen 158 and the third liquid reservoir 135.

[0199] As depicted in Figure 1, a fourth liquid reservoir 145 can also be provided, the fourth reservoir being in fluid communication with at least one of the first, second, and third reservoirs, serving as an additional supply of fluids. This reservoir can be used to store and deliver supplementary therapeutic agents. However, this additional reservoir is optional.

[0200] In Figure 1, the fourth reservoir 145 is connected to the first and second reservoir via connector 160. The fourth reservoir 145 is also connected to the third reservoir via connector 162. In addition, the third reservoir 135 is in communication with the colibri connector 150 via connector 164.

[0201] In addition to the primary purge mechanism, the system can further comprise a second purge mechanism, which includes a piston and a reservoir arranged in series with the first purge mechanism. This second purge piston is configured to operate in a synchronized manner with the first purge mechanism to maintain a constant fluid volume within the system while inducing controlled pressure waves. By alternately generating positive and negative pressure variations, this mechanism enables precise modulation of fluid dynamics within the inflatable balloon, thereby optimizing vessel compliance during inflation and enhancing the controlled delivery of shockwave therapy.

[0202] The second purge mechanism (not illustrated in the Figure) is designed to work in conjunction with the first, ensuring that pressure waves are introduced without altering the overall volume (neutral volume) within the system. This functionality enables automated shockwave therapy by synchronizing piston movements to create localized oscillations within the balloon. In particular, the system is configured to generate predefined cavitation bubbles based on the pressure-volume (P / V) curve by actuating an additional piston. This piston, operating in conjunction with the primary purge mechanism, moves in an opposing manner to the first purge piston, ensuring that the total system volume remains constant whilefacilitating the controlled formation of cavitation bubbles within the fluid. The two pistons may be arranged in series or coaxially, with one piston positioned inside the other, depending on the system configuration. Regardless of their arrangement, their synchronized opposing movements induce rapid pressure variations, allowing for controlled cavitation bubble formation without any net displacement of liquid.

[0203] This volume-neutral displacement is critical for generating reproducible pressure waves, ensuring that energy is efficiently transferred to the vessel without causing unwanted fluid movement. By precisely modulating the timing and amplitude of these piston movements, the system enables the creation of pressure waves optimized for vessel compliance modulation, calcification treatment, and other therapeutic applications. The ability to generate controlled cavitation within a neutral volume displacement framework allows for highly targeted energy delivery, which can be used to break down calcified lesions, improve vessel compliance, and facilitate drug delivery within the vessel lumen.

[0204] Beyond cavitation bubble formation, the system can also provide the generation of resonance-based pressure wave therapy. Through precise piston actuation, standing pressure waves can be generated within the balloon, creating localized high-amplitude oscillations while maintaining a stable overall volume. This ensures that energy is effectively delivered to the treatment site without requiring large-scale fluid displacement. By leveraging this resonance effect, the system provides an advanced therapeutic solution for improving vessel preparation, optimizing therapeutic delivery, and enhancing procedural consistency in interventional cardiology. The ability to modulate resonance amplitude dynamically allows for tailored energy delivery depending on vessel characteristics, ensuring that therapeutic interventions remain both effective and safe.

[0205] Additionally, the system may incorporate a solid-core shaft mechanism, which enhances precision by generating controlled pressure variations without requiring significant fluid displacement.

[0206] The purging mechanism described above is very important. Indeed, as highlighted in the study by Marrero et al. (Marrero HGD, et al. Role of Autophagy in Pulmonary Fibrosis. Journal of Clinical Medicine. 2020;9(l):172), proper balloon preparation is critical to the success of percutaneous coronary interventions (PCI). The research emphasizes that incomplete preparation of angioplasty balloons— such as the presence of residual airbubbles— can compromise the accuracy of pressure readings, increase the risk of procedural complications, and reduce therapeutic efficacy. Air bubbles trapped within the balloon can lead to false pressure-volume (P / V) readings, potentially resulting in under-expansion, embolism, or poor stent deployment. These findings underscore the importance of ensuring that balloons are adequately purged of air before inflation.

[0207] Before any intervention, it is thus crucial to prepare the balloon to ensure accurate pressure-volume readings and effective therapy delivery.

[0208] The system includes a purging mechanism integrated in a Colibri Connector according to the present invention. This coaxial luer lock system is designed to:

[0209] • Inject liquid into the balloon while simultaneously aspirating residual air through an inner (or external) tube.

[0210] • Ensure consistent and thorough air removal, eliminating variability caused by manual purging methods.

[0211] By removing all air bubbles, the system guarantees reliable P / V measurements and optimal balloon compliance. This allows simultaneous aspiration and liquid injection, ensuring an efficient and highly reproducible debubbling process.

[0212] The concept of a coaxial Luer lock system with an inner tube for simultaneous fluid injection and air aspiration represents a significant advancement over traditional Luer lock designs. Standard Luer lock connectors are widely used in medical devices but are primarily configured to provide a single fluid pathway for secure and leak-proof connections. While prior patents, such as EP0869826B1 and US4294250A, address enhancements in sealing and engagement mechanisms, none describe a coaxial configuration that enables dual functionality for air removal and fluid injection within the same system.

[0213] The Colibri Connector 150, illustrated in Figure 2, is a specialized coaxial Luer lock system designed to facilitate efficient fluid management and air removal. The connector comprises a dynamic, adaptive-length mechanism, allowing it to adjust to different Luer lock geometries while maintaining a secure and fluid-tight engagement. This adaptability ensures compatibility across a wide range of catheter and balloon systems, optimizing procedural reproducibility and eliminating manual variability.The Colibri Connector 150 comprises an elongated aspiration lumen, or "tongue" 158 , which extends deep into the corresponding male Luer lock 157 and beyond the female Luer lock 154. The system comprises a coaxial dual-lumen structure, wherein the inner lumen 158 is configured for air aspiration and fluid displacement, while the outer lumen 156 facilitates liquid injection. Depending on the procedural requirements, the system can also function in reverse, with the inner lumen delivering liquid and the outer lumen aspirating residual air.

[0214] At the distal end, the Colibri Connector 150 interfaces with the catheter and inflatable balloon. The balloon can be first attached via a standard Luer lock system. The external portion of the connector 154 incorporates threading to ensure a secure fit, while the male Luer lock 157 houses the Colibri tongue 158. Upon connection, the Colibri tongue extends into a chamber that initially contains air. During the purging process, liquid is injected through the outer lumen 156, forcing the trapped air into the aspiration lumen 158. The tongue's extended reach ensures that all residual gas is evacuated, creating a fully air-free system.

[0215] The negative pressure created within the Colibri Connector 150 enhances the purging process. As liquid flows through the external lumen 156, it displaces trapped air, which is drawn into the aspiration lumen 158 and expelled from the system. This continuous application of negative pressure guarantees the removal of air pockets, preventing fluctuations in the pressure-volume (P / V) relationship that could compromise balloon inflation accuracy.

[0216] When a catheter is secured to the female Luer lock 154 of the Colibri Connector 150, the system maintains a constant negative pressure, allowing the catheter and balloon to move freely while ensuring continuous fluid exchange. This capability is critical in interventional cardiology procedures, where maintaining an air-free environment is essential for accurate pressure monitoring and vessel preparation. The coaxial lumen structure of the connector significantly enhances procedural reliability by allowing simultaneous aspiration and liquid injection, optimizing the inflation process.

[0217] The Colibri Connector 150, in addition to its primary function as a fluid management system, is configured to cooperate with a metallic shaft (or solid core shaft) or wire that extends through its inner lumen 158 into the connected balloon system.Furthermore, the metallic shaft can transmit vibrations, facilitating therapeutic interventions such as shockwave therapy or targeted lesion modification.

[0218] In certain embodiments, the Colibri Connector 150 is further adapted to dynamically modulate internal balloon pressure. A small volume of liquid is initially injected into the balloon, followed by the insertion of a metallic shaft or wire through the inner lumen 158. This metallic shaft interacts with the liquid inside the balloon, allowing for precise pressure modulation without requiring significant fluid displacement. By controlling the movement of the metallic shaft within the balloon, it generates controlled pressure variations, which can be leveraged for therapeutic applications, including vessel compliance modulation and calcification treatment.

[0219] By oscillating or vibrating within the balloon, the metallic shaft effectively acts as an internal piston, generating localized mechanical waves that enhance therapeutic outcomes. The coaxial lumen design of the Colibri Connector 150 ensures that while the solid-core shaft is inserted, fluid displacement remains controlled, preventing unintended volume changes while allowing for precise pressure regulation.

[0220] Pressure-Volume Monitoring

[0221] In addition, the invention continuously monitors the P / V relationship during balloon inflation. This enables the system to:

[0222] • Detect calcified lesions by identifying abrupt increases in pressure relative to volume changes.

[0223] • Provide real-time feedback to operators, allowing precise adjustments to inflation pressure and therapy delivery.

[0224] • Differentiate between compliant and non-compliant balloon behavior, adapting dynamically to vessel conditions.

[0225] If we were to follow the volume simultaneously to the pressure, we would be able to identify obstacles or calcifications as the balloon inflates. For example, a sudden increase in pressure with minimal volume change may indicate a calcified region. The system uses this information to guide therapy and ensure proper vessel preparation.In angioplasty, nominal pressure and rated burst pressure (RBP) are critical parameters for balloon catheter performance. Nominal pressure refers to the pressure at which the balloon achieves its intended diameter, typically ranging between 6-10 atmospheres (atm), ensuring safe and effective vessel dilation. Rated burst pressure, on the other hand, represents the maximum pressure the balloon can withstand without bursting, usually ranging from 14-20 atm. While nominal pressure is used during standard inflations, RBP is approached cautiously in cases requiring high-pressure inflations to treat resistant or calcified lesions. These parameters are essential for balancing procedural safety and efficacy.

[0226] In the system, the means to monitor the pressure and volume of the balloon during inflation can be achieved through a combination of sensors and controlled fluid delivery mechanisms:

[0227] A pressure sensor 1250 can be integrated within the fluid pathway, preferably positioned inside the syringe assembly, near the Colibri Connector or within the catheter system. This placement ensures direct and precise measurement of the pressure applied by the fluid as it is delivered to the inflatable balloon. The sensor continuously monitors real-time pressure variations and transmits data to a processor for analysis. Sudden changes in pressure can indicate resistance within the vessel, such as contact with a calcified lesion, allowing for immediate therapeutic adjustments to optimize vessel compliance and treatment efficacy.

[0228] The volume of the balloon can be determined by tracking the precise amount of liquid injected into the balloon. This can be achieved using a high-precision piston system, which can control and measure the displacement of liquid from the reservoirs into the catheter. By monitoring piston movement, the system can calculate the exact volume of fluid delivered to the balloon. By simultaneously tracking pressure and volume, the system can generate real-time P / V curves. These curves can allow the system to detect obstacles, assess vessel compliance, and adapt inflation strategies dynamically. For example, a steep rise in pressure with minimal volume change can suggest a rigid, calcified area, and a gradual increase in both pressure and volume can indicate normal vessel expansion. Means to measure the volume will be further described in accordance with different embodiments of the invention.

[0229] The system can use this information to adjust therapy, optimize inflation sequences, and ensure controlled vessel preparation.

[0230] Guided Shockwave TherapyThe system provides the use of guided shockwave therapy using water column cavitation instead of traditional piezoelectric elements. Key advantages include:

[0231] • Targeted delivery of shockwaves to fracture calcifications without damaging surrounding tissues.

[0232] • Modulation of therapy parameters (e.g., frequency, amplitude, duration) based on real-time P / V feedback.

[0233] • Compatibility with all balloon types, eliminating the need for specialized devices.

[0234] The cavitation process involves creating implosive bubbles that generate localized mechanical stress, breaking down calcifications effectively. By utilizing the P / V data, the system can deliver shockwaves precisely where needed.

[0235] Traditional balloon inflation systems rely on measuring inflation pressure alone, lacking the ability to dynamically track volume changes during inflation. This limitation prevents real-time assessment of vessel compliance, balloon expansion efficiency, and lesion resistance. In cases involving calcified or non-compliant lesions, a balloon may reach its target pressure but fail to expand symmetrically, leading to suboptimal vessel preparation or even vascular injury.

[0236] Moreover, conventional systems do not account for air removal (debubbling) with precision. Residual air in the system alters pressure readings, reduces procedural accuracy, and increases the risk of embolism. The present invention addresses these challenges by providing different approaches, all based on the same functionalities: from a manual indeflator for precise operator-controlled inflation and therapy, a hybrid or semi-automatic system to a robotic system with a cassette-based architecture for fully automated balloon inflation and therapy administration.

[0237] The system described in Figure 1 can be fully automated and integrated into a robotic-assisted system, as further described in relation to Figure 12. Such a system can provide real-time control over balloon inflation and therapeutic delivery. The system of Figure 1 can also be implemented in a manual version, or semi-automatic version, as will be further described below.

[0238] The system can be provided with a manual indeflator, as illustrated in Figure 3. The indeflator 300 is configured to precisely control the inflation and deflation of an inflatableballoon within a blood vessel while simultaneously monitoring pressure-volume (P / V) relationships in real time. The means to measure pressure and volume are not shown in the Figure. As in the other embodiments, the manual indeflator 300 comprises: a main piston 310 configured to move liquid from a first liquid reservoir 315 to the inflatable balloon, controlling inflation. The manual indeflator also comprises a second piston 320, positioned inside the main piston 310, configured to deliver therapeutic interventions by generating pressure or acoustic waves. In a first version as illustrated in Figure 3, the second piston 320 uses a spring mechanism 522 that stores mechanical energy during piston movement, releasing it to produce pulsatile pressure waves, facilitating shockwave therapy.

[0239] The system can also be provided in an alternative embodiment with a manual indeflator, as illustrated in Figure 4. As in the other embodiments, the manual indeflator 400 comprises a main piston 410 configured to move liquid from a first liquid reservoir 415 to the inflatable balloon, thereby controlling inflation. In this second embodiment, the manual indeflator further comprises a second piston 420, positioned inside the main piston 410, which is configured to deliver therapeutic interventions by generating acoustic waves rather than pulsatile pressure waves. Unlike the first embodiment, where the second piston operates with a spring mechanism to store and release mechanical energy, the second piston 420 in this embodiment is configured to generate controlled oscillations or vibrations. These oscillations produce localized acoustic waves that propagate within the fluid-filled system, enabling targeted therapy within the vessel.

[0240] The acoustic wave generation is achieved through precisely controlled movement of the second piston 420, which oscillates at predetermined frequencies to induce mechanical pressure waves. This mechanism allows the system to modulate vessel compliance, facilitate calcification treatment, or enhance drug penetration in a more controlled and continuous manner compared to shockwave therapy. By integrating acoustic wave generation into the manual indeflator, this embodiment provides an improved therapeutic approach, expanding the versatility of the system while maintaining real-time pressure-volume monitoring and precise fluid management.

[0241] To enable pressure and volume monitoring, as in the other embodiments, the indeflator integrates a pressure sensor within the fluid pathway (not shown), allowing realtime monitoring of inflation pressure. A volume measurement mechanism is linked to the piston's displacement, ensuring precise calculation of the fluid volume delivered to the1

[0242] balloon. This dual monitoring capability provides immediate feedback on balloon expansion, allowing the operator to detect resistance, calcifications, or incomplete inflation.

[0243] Beyond inflation control, the indeflator supports therapeutic interventions, including shockwave therapy and drug delivery. The system is capable of generating targeted pressure waves through a water column, enabling the fracturing of calcifications. Additionally, it facilitates the infusion of liquid-based medication or the controlled operation of drug-coated balloons (DCB) to enhance therapeutic outcomes.

[0244] An improved version of the manual indeflator is illustrated in Figures 5 and 6. The indeflator system is designed to provide controlled balloon inflation, pressure-volume measurement, and therapeutic intervention. It incorporates a dual-piston mechanism housed within a syringe-based device, allowing the operator to manually regulate inflation pressure, volume displacement, and the application of shockwave therapy or pulsatile therapy waves. The system provides real-time feedback via pressure-volume monitoring and can be equipped with a wireless communication module for data transmission to an external display.

[0245] The manual indeflator 500 is designed for precise fluid delivery, pressure-volume (P / V) monitoring, and therapeutic intervention through controlled shockwave generation. The system comprises a main piston 510, a therapy piston 520, a turning knob 560, a trigger mechanism 580, and a syringe assembly 570.

[0246] The main piston 510, similar to the main piston 110 of Figure 1, is responsible for inflating the balloon and is operated via the turning knob 560, which is connected to a gearbox and a rotary encoder. This configuration ensures precise control over the movement of the main piston 510, allowing the operator to accurately regulate the volume of fluid delivered to the balloon catheter. The piston is actuated through a rack-and-pinion mechanism, which enables smooth linear displacement. A linear encoder is attached to the main piston 510 to provide absolute volume measurement, ensuring more accurate fluid control compared to conventional systems that infer volume from piston movement.

[0247] Inside the main piston 510, the therapy piston 520 (similar to the therapy piston 120 of Figure 1) is provided for generating shockwaves to facilitate therapeutic intervention. The therapy piston 520 can operate using three distinct working principles: automatic tremulation through continuous oscillations, pull-and-release shockwave generation for controlled impact delivery, and full manual activation through direct operator-applied force.The amplitude and intensity of the shockwaves can be adjusted based on the retraction force applied to the therapy piston 520, allowing for precise modulation of therapeutic energy. The therapy piston 520 can be arranged coaxially within the main piston 510 or integrated via a side port, depending on the system configuration.

[0248] The trigger mechanism 580 allows for three distinct control states. In the distal position, the system is disengaged, preventing unintended actuation. In the mid-position, the gear system is engaged without activating the measurement system, allowing for piston positioning before measurement begins. When fully pulled, the trigger 580 resets the volume measurement to zero, providing a relative reference point for real-time tracking and engaging the measurement function.

[0249] The syringe assembly 570 is equivalent to the first fluid reservoir of Figure 1, and is configured to contain a predefined liquid volume and can be implemented in two configurations: a pre-installed fixed unit or a cartridge-based system. The cartridge system allows for rapid syringe replacement and sterile operation, ensuring efficient procedural workflow.

[0250] The manual indeflator 500 can be further equipped with a purging mechanism to eliminate residual air from the system before balloon inflation. The operator manually purges air by pushing liquid through the system. In some embodiments, a secondary reservoir can be provided to separate air from liquid, ensuring that only air-free liquid enters the balloon catheter, as described further in reference to Figure 10. Additionally, the Colibri Connector can be integrated as an optional component to automate the purging process, enhancing consistency and reproducibility between multiple balloon inflations.

[0251] The system also includes advanced pressure and volume measurement capabilities. Unlike prior-art indeflators that estimate volume based on piston displacement, the manual indeflator 500 integrates rotary and linear encoders to provide relative position and absolute position depending on the starting point of inflation. A pressure sensor is positioned within the fluid pathway to continuously monitor real-time pressure variations, ensuring accurate control over inflation dynamics and providing feedback for therapeutic interventions.

[0252] Beyond standard inflation control, the system enables cavitation-based therapy by utilizing rapid fluid acceleration to form predefined cavitation bubbles. These bubblesgenerate secondary shockwaves, facilitating precise lesion treatment. The therapy piston 520, through controlled mechanical actuation, allows the operator to manually induce cavitation and shockwave effects within the liquid-filled chamber, enhancing the efficacy of vessel preparation and calcification treatment.

[0253] Figure 6 illustrates an embodiment of the manual indeflator 500, similar to Figure 5 but providing additional views on key electronic components and measurement systems that enhance operator control and procedural monitoring. This embodiment integrates advanced sensing, communication, and control features to improve precision and usability.

[0254] The manual indeflator 500 includes a button 680, which serves as the activation control for the system, allowing the operator to power on and engage the electronic monitoring and therapy components. A rotary encoder 685 is connected to the turning knob 560, ensuring accurate rotational tracking of the main piston 510. This encoder provides high-resolution feedback, enabling precise volume control based on piston displacement.

[0255] To facilitate real-time data monitoring and connectivity, the system may comprise a wireless communication module 690, which can be housed within a battery insertion bay 692. This battery is reusable and provides power to the electronic components of the indeflator, ensuring continuous operation across multiple procedures. The connector plate 693 interfaces with the battery and communication module, establishing stable electrical connections for power supply and data transmission.

[0256] For accurate fluid control, the system integrates a linear encoder 618, which operates as a caliper-based measurement device to track the linear displacement of the main piston 510. This encoder ensures absolute volume measurement, enhancing accuracy over conventional piston-displacement-based estimations. Additionally, a fluid-contact pressure sensor 1250 can be included within the fluid pathway (not shown in the figure), providing continuous real-time pressure monitoring. This sensor enables precise assessment of balloon inflation, detecting resistance variations, and ensuring controlled therapeutic delivery.

[0257] To further improve operator control and procedural monitoring, the manual indeflator 500 can utilize the wireless communication module 690 to transmit real-time pressure-volume (P / V) data to an external display system. This feature allows the operator to visualize live pressure fluctuations, track therapy progression, and receive alerts for procedural adjustments. By integrating these electronic and communication enhancements, the manualindeflator 500 ensures a high level of precision in fluid delivery, therapeutic interventions, and real-time monitoring, making it a highly effective tool for interventional cardiology procedures.

[0258] To ensure precise operation, the manual indeflator integrates a highly responsive trigger mechanism, which allows the operator to control piston engagement and measurement with three distinct positions: disengaged (for free movement), mid-position (for precise piston positioning without measurement activation), and fully engaged (for zeroing volume and pressure measurement). Additionally, the system incorporates rotary and linear encoders, ensuring absolute volume measurement rather than inferred displacement tracking, significantly improving procedural accuracy. The ergonomic, ambidextrous design enables left-and right-handed use, enhancing operator control. Furthermore, the system can function in manual, hybrid, or fully automated modes, allowing the physician to intervene when necessary or rely entirely on pre-programmed inflation sequences. Whether operating in a physician-assisted or fully automated mode, the system ensures real-time pressure-volume monitoring, optimizing vessel compliance during balloon inflation. Moreover, the integration of the Colibri Connector across both manual and robotic systems guarantees reproducible debubbling, eliminating residual air and ensuring precise, controlled inflation. These features collectively enhance safety, procedural efficiency, and therapeutic outcomes in interventional cardiology.

[0259] Figure 7 illustrates an embodiment of the indeflator 500 integrated within the operating room system, facilitating real-time monitoring and procedural control during interventional cardiology procedures. The indeflator 500 is designed to provide precise balloon inflation control, continuous pressure-volume monitoring, and therapeutic intervention while wirelessly or physically communicating with an external display unit.

[0260] Prior to use, the system undergoes a purging process according to the instructions for use, ensuring the removal of residual air and preparing the system for inflation. Once the purging is completed, the communication module is inserted into the indeflator 500, enabling data transmission to the external display unit 700. The operator then pulls the trigger, setting the current piston position and pressure to zero, thereby establishing a baseline for volume and pressure measurements.

[0261] Following activation, the indeflator 500 begins continuous recording of piston positions and pressure data. This data is wirelessly transmitted to the display unit 700, where key procedural information is presented. The display 700 provides real-time feedback,including target values for a given balloon size, specifying the recommended volume and pressure for optimal inflation. Additionally, the current values of the procedure are displayed, incorporating real-time pressure readings from the pressure sensor and volume measurements derived from encoders tracking piston displacement.

[0262] The real-time display of pressure-volume data allows the physician 750 to assess procedural progress and determine whether additional therapeutic intervention is necessary. Based on the displayed information, the physician 750 can manually adjust inflation parameters or activate therapeutic features, such as shockwave therapy or additional fluid modulation.

[0263] In alternative embodiments, the system can operate in a fully automated mode, wherein the indeflator 500 autonomously adjusts inflation parameters and triggers therapeutic interventions based on real-time pressure-volume analysis.

[0264] The communication between the indeflator 500 and the display unit 700 is preferably wireless, ensuring seamless data transmission and allowing flexible placement of equipment within the operating room. However, the system may also be configured for a wired connection.

[0265] By integrating real-time monitoring, wireless data transmission, and precise control over inflation parameters, the system enhances procedural safety, improves therapeutic precision, and supports efficient decision-making in interventional cardiology.

[0266] Figures 8 and 9 illustrate an implementation of how the therapy piston 520 in manual mode can generate shockwaves manually. The system incorporates a mechanically-actuated spring mechanism that enables controlled energy release, allowing the operator to apply shockwaves in a precise and repeatable manner. The therapy piston 520 is housed within a primary chamber and operates in conjunction with a rack and pinion system, which serves to displace fluid, measure volume, and apply controlled pressure.

[0267] The mechanism includes a spring 830 with adjustable pretension, which can be compressed and then suddenly released to generate high-energy impulses. The spring operates between two states: a decompressed state 830a and a compressed state 830b. When compressed, the therapy piston 520 moves upward, storing mechanical energy. The system utilizes a half-tooth gear mechanism 840, which enables controlled engagement and disengagement of the piston. As the outer sleeve is turned, it compresses the spring. Once thehalf-tooth gear 840 reaches its highest point, the spring 830 rapidly decompresses, resulting in a sudden downward release of the piston 520, generating a high-intensity impact force.

[0268] Additionally, the therapy piston 520 can be manually actuated in multiple ways, allowing for different therapeutic applications. The operator can engage the system through:

[0269] Rotational actuation (automatic tremulation): By continuously turning the outer sleeve 840, the system generates rapid, repetitive oscillations, producing a controlled vibratory effect.

[0270] Pull and release (shock-peak impact): The operator manually pulls back on the therapy piston 520, compressing the spring 830. Upon release, the stored energy is suddenly discharged, delivering a high-intensity shockwave.

[0271] Direct impact (manual strike): The operator applies a physical impact to the therapy piston, triggering a high-energy release.

[0272] The rack and pinion mechanism ensures fluid displacement in a controlled manner. Within the main piston chamber, an internal cavity houses the therapy piston 520, which interacts with the toothed surface of the mechanism. The half-tooth gear configuration allows the teeth to slide against each other during compression and suddenly disengage at the peak of the cycle, ensuring a sharp and precise energy release. The engagement of the gear teeth ensures uniform amplitude across multiple shockwave applications, typically engaging 4 to 6 teeth at the point of maximum compression.

[0273] To allow for amplitude modulation, the system enables the operator to control the degree of compression. Pulling back further on the piston generates larger shockwaves, while rotating the outer sleeve results in smaller, rapid oscillations, allowing for a range of therapeutic intensities. The design ensures that regardless of the method used, the applied shockwave energy remains controlled and does not exceed a predetermined pressure threshold. For instance, if the balloon is inflated to 15 atm, all shockwaves generated remain within the safe pressure limits, preventing overexpansion.

[0274] Figure 9 provides a close-up view of the half-tooth mechanism 840. The mechanism consists of interlocking gear teeth, which engage and slide against each other as the outer sleeve is turned, gradually compressing the spring 830. Once the maximum compression is reached, the engagement suddenly disengages, allowing the spring todecompress instantaneously and causing the therapy piston 520 to be rapidly propelled downward, generating a high-intensity impact force.

[0275] The half-tooth gear mechanism is designed to enable up to a predefined number of shockwaves per turn, typically ranging from 2 to 6 impacts, depending on the selected configuration. The operator can adjust the amplitude of the generated shockwaves by modifying the level of compression applied to the spring 830. By increasing or decreasing the engagement depth of the half-teeth, the system allows for fine-tuned control over the intensity of each shockwave, ensuring optimal therapeutic effectiveness while maintaining procedural safety.

[0276] This adjustable amplitude feature is particularly beneficial in tailoring therapy to patient-specific needs, as it allows operators to deliver varying levels of mechanical energy depending on lesion characteristics. The system ensures that shockwave impulses remain controlled and reproducible, offering an efficient and user-friendly solution for manual shockwave therapy in interventional cardiology applications.

[0277] The manual shockwave therapy mechanism, as illustrated in Figures 8 and 9, is fully compatible with all embodiments described in the present invention. This includes both the manual indeflator system and the robotic system utilizing a cassette-based configuration. The adaptable nature of the mechanism allows it to be seamlessly integrated into different implementations without requiring significant modifications.

[0278] In the manual system, the therapy piston 520, in combination with the half-tooth gear mechanism 840 and adjustable spring 830, enables the operator to generate shockwaves manually by either turning, pulling, or releasing the actuator.

[0279] In the robotic system, the same mechanical shockwave principle can be replicated through motorized control, where actuators replace manual input to regulate piston movement and generate controlled pressure waves. The half-tooth mechanism can be adapted to function within the cassette-based system, where the shockwave amplitude and frequency are automatically adjusted based on real-time pressure-volume (P / V) monitoring.

[0280] Figure 10 illustrates another embodiment of a manual indeflator 1000 configured for balloon inflation, therapeutic intervention, and controlled fluid management. The indeflator comprises a manually actuated main piston 1010, which is responsible for controlling the inflation of the balloon by displacing liquid from the system. The main piston1010 is designed to operate in conjunction with a coaxial, manually actuated therapy piston 1020, which enables the application of targeted mechanical impulses or pressure waves within the system for therapeutic interventions.

[0281] The system includes a first liquid reservoir 1015, which supplies liquid for inflation and therapeutic applications. Within the first chamber, a cavitation zone 1060 can optionally be provided, comprising a narrowing inside the first liquid reservoir 1015. This narrowing accelerates the fluid flow, thereby generating pressure variations that lead to the formation of cavitation bubbles. The controlled collapse of these bubbles induces secondary shockwaves, which can be used for targeted treatments such as calcification modification. Additionally, when therapy is applied, cavitation zone 1060 further enhances bubble formation, optimizing the energy transfer for shockwave therapy.

[0282] A purge chamber 1035 is also provided into the system and comprises a purge piston 1030. The purge piston 1030 is equipped with unidirectional flow valves, allowing repetitive purging cycles, similar to the function of a bicycle pump. The purge mechanism operates in a closed-loop system, ensuring that liquid is continuously recirculated into fluid reservoir 1045, which is fluidly connected to the first liquid reservoir 1015. This configuration ensures a consistent liquid supply for the procedure.

[0283] To ensure precise pressure regulation, a pressure sensor 1250 can be positioned within the fluid pathway, continuously monitoring pressure variations. The pressure sensor 1250 can also be provided inside the first liquid reservoir 1015 to measure the pressure in real time.

[0284] Liquid flows either from the first reservoir 1015 or the fluid reservoir 1045 through liquid lumen 166, the external coaxial pathway of the lumen 165 connected to the colibri connector 150. During purging, the fluid is recirculated inside the system via the Colibri tongue 158, which directs it into the air lumen 164. The purge piston 1030 generates negative pressure to aspirate air, ensuring an effective debubbling process. If liquid is present in the aspiration pathway, it is redirected into fluid reservoir 1045, maintaining a stable and efficient system operation.

[0285] The therapy piston 1020 is capable of performing shockwave therapy as described in the present application. It generates controlled impulses, facilitating vessel preparation by modulating vessel compliance or aiding in calcification treatment.Robotic system

[0286] The various systems described above can be seamlessly adapted into a fully robotic system 1200, incorporating the same features while automating their operation. The robotic system is illustrated in Figure 12 and is specifically designed to enhance balloon inflation, therapeutic delivery, and air purging in interventional cardiology procedures by eliminating manual variability and ensuring precise, reproducible performance. It comprises a robotic unit 1160 that autonomously controls multiple motor-driven pistons, enabling accurate fluid management and dynamic therapeutic interventions with minimal operator input. The system further integrates a sterile, prefilled cassette 1150 containing multiple liquid reservoirs facilitating efficient and standardized procedures.

[0287] The cassette 1150 is fluidly connected to the Colibri Connector 150 via lumen 165, ensuring efficient bidirectional aspiration and liquid delivery during operation. In the robotic system, both the cassette and the Colibri Connector are designed as disposable components, allowing for single-use applications to maintain sterility and eliminate cross-contamination risks. However, the robotic unit 1160 itself is a reusable component, engineered for durability and long-term operation across multiple procedures.

[0288] In the robotic unit 1160, a main piston is configured to move liquid from a first liquid reservoir to the inflatable balloon 10, providing controlled inflation. A second piston is responsible for delivering therapeutic interventions, such as drug infusion or shockwave therapy, by directing liquid from a second reservoir into the balloon. Additionally and optionally, a purge piston removes residual air from the balloon by channelling liquid and air into a third reservoir, ensuring precise pressure-volume (P / V) monitoring and optimal balloon compliance.

[0289] The cassette 1150 serves as a disposable, sterile unit that connects to the robotic unit 1160 and contains the first, second, and third liquid reservoirs. It is designed to facilitate efficient and contamination-free fluid handling while integrating seamlessly with the robotic system. The cassette is fluidly connected via lumen 165 to the Colibri Connector 150, which acts as an interface for liquid injection and aspiration, further optimizing air removal and fluid management.

[0290] A processor is integrated into the system to control and monitor the robotic operations, including the movement of the main, second, and purge pistons. The processoranalyzes real-time P / V curves, detecting abrupt pressure changes indicative of vessel resistance or calcified lesions. The robotic unit 1160 can operate in a fully automated mode, adjusting inflation and therapy parameters based on real-time data, or in a hybrid mode, where the operator can manually intervene using a handheld controller 1650.

[0291] The system further comprises a display unit 700 that provides a continuous visual representation of P / V curves, enabling real-time procedural feedback. This allows for precise monitoring of balloon behavior, supporting clinical decision-making regarding inflation pressure, vessel compliance, and therapeutic interventions. The handheld controller allows manual activation of the main and second pistons for controlled fluid delivery and therapy application. The controller 1650 can also include tactile feedback to alert the operator of resistance encountered during balloon inflation or variations in the P / V curves, indicating the presence of calcified lesions.

[0292] To ensure adaptability across different balloon types, the system may include identification means such as RFID readers or QR code scanners. These technologies allow automatic recognition of the specific balloon model, retrieving its parameters for optimized inflation pressure, compliance characteristics, and nominal diameter specifications. This feature ensures compatibility with various balloon types while improving procedural efficiency and safety.

[0293] For pressure and volume measurement, the system incorporates a pressure sensor integrated into the fluid pathway to provide real-time monitoring. Volume measurement can be achieved using position sensors or step counters associated with piston movement, allowing for precise liquid displacement tracking. Additionally, direct volume measurement methods can be implemented for enhanced accuracy.

[0294] The robotic system is further configured to support cavitation-based therapy and resonance-based pressure wave therapy. By synchronizing piston movements, the system can generate controlled cavitation bubbles within the liquid, enhancing the therapeutic impact without altering the system's overall volume. This capability allows for targeted shockwave therapy with optimized energy transfer to the treatment site. Additionally, the system can create standing pressure waves within the balloon, leveraging resonance effects to generate high-amplitude oscillations while maintaining a stable volume.Figure 11 illustrates an embodiment of the robotic system, designed to automate balloon inflation, air purging, and therapy delivery using a sterile, prefilled cassette 1150. The cassette integrates multiple components to ensure efficient and precise fluid management, enabling seamless operation in conjunction with the Colibri Connector.

[0295] The cassette 1150 is configured to be operatively connected to a robot system, where robotic unit 1160 facilitates the mechanical connection between the pistons and the robot's actuators, allowing precise control over fluid dynamics. Within the cassette, a purge chamber 1035 is configured to apply negative pressure via the Colibri Connector 150 or, alternatively, to operate in reverse, expelling air and ensuring complete air removal while maintaining a fluid-tight system. The purge chamber 1035 can communicate via a valve 1005 directly with the first chamber or an external fluid reservoir, ensuring a continuous supply of liquid without introducing air into the system.

[0296] The first chamber 1015 houses the main piston 1010, which is responsible for applying volume and pressure during balloon inflation. Coaxially arranged within the main piston is the therapy piston 1020, which is configured to generate therapeutic effects such as tremulation, pressure fluctuations, or controlled cavitation bubble formation. The coordinated actuation of these pistons ensures a smooth inflation process while enabling advanced therapeutic applications, such as shockwave therapy or vessel compliance modulation.

[0297] The purge chamber 1035 and the first chamber 1015 are fluidly connected via conduit 1005, ensuring efficient recirculation of liquid throughout the system. The system further incorporates coaxial tubing 165, which serves as the primary conduit for bidirectional fluid movement. The tubing 165 consists of an inner lumen 164 dedicated to air aspiration and an external coaxial lumen 166 for liquid insertion, ensuring efficient debubbling and precise liquid delivery, as already described in reference to the other embodiments. The inner lumen 164 is fluidly connected to the third reservoir 1035, facilitating continuous air removal from the system, while the external lumen 166 is fluidly connected to the first chamber 1015, enabling controlled liquid delivery into the inflatable balloon. This configuration optimizes air removal and prevents the introduction of unwanted air into the balloon.

[0298] A second purge mechanism can be integrated alongside the first to maintain a neutral system volume while generating controlled pressure waves. This volume-stable approach enables efficient shockwave therapy without requiring significant fluid displacement,ensuring both precision and safety. The robotic system further enhances procedural consistency by automating the debubbling process, continuously eliminating residual air between therapy applications to achieve precise and repeatable inflation cycles. The Colibri Connector plays a key role in this functionality by enabling bidirectional aspiration, effectively preventing trapped air from disrupting pressure measurements. By coordinating the operation of the secondary purge piston with the primary system, controlled pressure oscillations can be generated, facilitating energy transmission for shockwave therapy while minimizing risks associated with excessive pressure fluctuations.

[0299] Pressure-Volume (P / V) Monitoring and Therapy Adjustments

[0300] The robotic system provides automated real-time monitoring of pressure-volume (P / V) curves, allowing for continuous detection of calcifications and dynamic therapy adjustments. The processor precisely controls piston operations to optimize fluid delivery, pressure modulation, and therapeutic application, ensuring consistent and reproducible balloon inflation.

[0301] Shockwave and Resonance-Based Therapy

[0302] The system can also be configured to provide automated shockwave therapy, by synchronizing different piston movements to generate localized, high-amplitude oscillations within the balloon while maintaining constant system volume. This enables controlled pressure variations without unintended fluid displacement. Additionally, resonance-based therapy can be generated by the system by creating standing pressure waves within the balloon, optimizing therapeutic energy delivery for enhanced vessel compliance modulation and calcification treatment. The ability to generate controlled resonance improves the efficacy of vessel preparation by enabling non-invasive modulation of calcified lesions, ensuring more effective and predictable therapeutic outcomes.

[0303] It is to be noted that the first, second, and third liquid reservoirs can be provided as separate reservoirs or may be combined into a single reservoir. Additionally, any two of these reservoirs can be merged, depending on the specific system configuration and fluid management requirements.

[0304] In certain embodiments, the robotic system is configured to include an automated calibration function, which dynamically adjusts the actuation profiles of the pistons based on detected variations in catheter resistance. This feature ensures that the system adapts tochanges in fluid dynamics, vessel compliance, or catheter stiffness, optimizing inflation precision and therapeutic delivery.

[0305] The system continuously monitors real-time pressure-volume (P / V) relationships during balloon inflation. If the processor detects unexpected resistance variations— for example, due to catheter positioning, vessel compliance changes, or partial obstructions— the calibration function modifies piston actuation parameters to compensate accordingly. This adjustment may involve:

[0306] Modifying piston stroke length to deliver precise fluid volumes. Adjusting actuation force based on resistance feedback, ensuring smooth and controlled inflation.

[0307] Altering pulse frequency in shockwave therapy mode to optimize therapeutic energy transfer without excessive pressure buildup.

[0308] By dynamically tuning piston operation, the automated calibration function enhances procedural accuracy, prevents catheter-induced pressure spikes, and ensures consistent performance across different catheter and vessel conditions. This feature is particularly advantageous in cases where real-time adjustments are necessary to maintain safe and effective therapeutic outcomes.

[0309] The calibration process can be performed automatically by the robotic processor, reducing operator intervention and ensuring standardized inflation and therapy delivery protocols. Additionally, the system may store historical calibration data, allowing for adaptive learning across multiple procedures, further refining its performance based on previous interventions.

[0310] The system may include an identification module configured to detect and retrieve parameters of the inflatable balloon. This identification module can comprise at least one of an RFID reader, a QR code scanner, or an optical recognition system. The module is designed to automatically recognize the specific balloon model, optimizing inflation pressure, compliance characteristics, and nominal diameter settings accordingly. This ensures compatibility with various balloon types while improving procedural efficiency and safety.

[0311] Furthermore, the robotic system may include an emergency stop mechanism, allowing for the immediate cessation of all piston operations in response to unexpectedpressure deviations or system malfunctions. This ensures patient safety by preventing excessive inflation pressure or unintended therapeutic application.

[0312] In contrast to systems in which pressure-volume measurements are used primarily for visualization, compliance estimation, or diagnostic interpretation, the present system utilizes real-time pressure-volume curve evolution as an active control variable governing piston actuation.

[0313] Specifically, the system detects deviations, non-linearities, discontinuities, or slope variations in the P / V curve and automatically adjusts inflation sequences and / or therapeutic piston activation accordingly.

[0314] Thus, the P / V relationship is not merely displayed or calculated but constitutes a closed-loop control parameter structurally integrated into the inflation and therapy architecture.

[0315] Manual Ergonomic Purge-Controlled Inflation Module

[0316] In a further embodiment of the system, illustrated schematically in Figures 13 and 14, the therapy system comprises a manually actuated inflation and therapy module configured to ensure automatic air purging, a predefined initial liquid volume, and reproducible operating conditions independent of repeated inflation and deflation cycles.

[0317] As illustrated in Figure 13, the system comprises a piston assembly (210) slidably arranged within a cylindrical chamber (215) containing an inflation liquid.

[0318] The piston (210) can be arranged with a slight inclination relative to the longitudinal axis (L) of the chamber (215). Due to buoyancy effects, any residual gas present in the chamber naturally accumulates in an upper region of the chamber.

[0319] The piston (210) comprises at least one purge opening or lateral slot (212) formed in a wall portion of the piston. When the piston (210) is advanced distally during an inflation movement, the inclined configuration causes accumulated air to be forced toward the purge slot (212). The air is thereby evacuated from the chamber before liquid is delivered toward the balloon catheter.

[0320] As a consequence, the liquid volume delivered to the balloon is substantially free of air, thereby improving pressure-volume measurement accuracy, safety, and repeatability.In the event that excess liquid is present in the chamber 215, the inclined geometry allows excess liquid to migrate above the piston 210, following an overflow path 213 (indicated schematically in Figure 13). Liquid located above the piston does not contribute to balloon inflation and is hydraulically excluded from the active inflation volume.

[0321] This configuration ensures that the system always starts from a predefined and reproducible initial liquid volume, regardless of whether the balloon has previously been inflated, deflated, or re-inflated.

[0322] As a result:

[0323] • injected volume can be calculated more accurately,

[0324] • pressure-volume (P / V) curves remain consistent,

[0325] • and repeated inflation cycles begin from identical initial conditions.

[0326] As illustrated in Figure 14, the manual inflation module comprises an handle assembly (1400). The handle assembly is preferably ergonomic and / or configured to enforce or naturally promote a substantially vertical operating orientation of the device during use.

[0327] The handle 1400 preferably comprises a grip portion 1402 shaped to align with the operator's hand in such a manner that the longitudinal axis (L) of the cylindrical chamber 215 is oriented vertically when the device is held in a natural gripping position. The handle may include a widened upper region and a narrowed lower region to bias the center of gravity downward, thereby stabilizing vertical orientation during actuation.

[0328] In the enforced vertical configuration:

[0329] • the liquid outlet 1420 can be positioned at the lower distal end of the chamber 215, • residual air migrates upward toward the purge region above the inclined piston 210, • liquid is delivered downward toward the balloon catheter under gravitational assistance.

[0330] The ergonomic geometry may further include:

[0331] a base support surface permitting temporary upright placement of the device on a sterile field,

[0332] an asymmetric mass distribution to discourage horizontal use,and optionally a tactile orientation marker indicating correct operating alignment. Unlike conventional indeflators that may be operated in arbitrary orientations, the present embodiment structurally guides the operator toward correct use. Air separation and purge efficiency are therefore achieved through mechanical design rather than reliance on operator technique.

[0333] The ergonomic handle 1400 cooperates functionally with the inclined piston (210) described in Figure 13. When the chamber is vertically aligned, buoyancy-driven gas migration is optimized, ensuring that residual air accumulates adjacent the lateral purge slot 212 prior to inflation.

[0334] The module may further comprise multiple manually operable control elements integrated into the handle structure, including:

[0335] • a first actuation element 1430, such as a rotatable knob or linear plunger, configured to advance the main piston 210 for controlled balloon inflation;

[0336] • a second actuation element 1430, configured to preload a mechanical energy storage mechanism for therapeutic pulse generation; The second actuation element is preferably the first actuation element. In this case, the first actuation element is configured for pushing and pulling by a user such that:

[0337] o when the first actuation element is pushed, the main piston advances, and o when the first actuation element is pulled, mechanical energy is stored in the compression spring 1470 such that, upon the release of the first actuation element by the user, the main piston advances.

[0338] • a release actuator 1450, configured to release stored mechanical energy and / or depressurize the system;

[0339] • a measurement actuator 1460, configured to activate, zero, or reset pressure-volume measurement.

[0340] The actuation elements may be arranged concentrically or axially within the handle assembly to permit single-hand operation.

[0341] In the present disclosure, the inclined piston or inclined configuration of the piston mean that a surface of a piston head of the piston is not normal to the longitudinal axisof the chamber. In other words, the longitudinal axis of the chamber is oblique with respect to the surface of the piston head. The surface of the piston head is the surface of the piston facing the interior of the chamber when the piston and chamber are assembled.

[0342] Preferably, an angle measured between a normal to the surface of the piston head and the longitudinal axis of the chamber is greater than 1°, more preferably greater than 5°. Preferably, this angle is comprised between 10° and 40°.

[0343] In this case, the piston and the chamber are preferably configured such that, when the longitudinal axis of the chamber is vertical, any residual gas present in the chamber moves towards a purge slot comprised in a lateral wall of the chamber under the effect of buoyancy .The internal mechanical shock generation mechanism integrated into the manual module is illustrated in Figure 15.

[0344] The module comprises a therapeutic piston assembly 1465 arranged within or adjacent to the main piston 210. The therapeutic piston assembly 1465 can be mechanically coupled to a compression spring 1470 forming a mechanical energy storage element.

[0345] During a charging phase, mechanical energy can be stored by manually compressing the spring 1470 via the second actuation element 1430. The second actuation element may comprise a sliding lever, rotary selector, or axial pull mechanism mechanically linked to the therapeutic piston.

[0346] The degree of compression of the spring 1470 may determine the amplitude of the therapeutic impulse.

[0347] A mechanical amplitude selector 1475 may be provided to define discrete preload levels of the spring 1470. The selector may comprise:

[0348] • a stepped indexing ring,

[0349] • a detent-based rotational mechanism,

[0350] • or a ratchet-type adjustment structure.

[0351] The amplitude selector 1475 can be configured to provide predefined therapeutic intensity levels, for example from level 1 to level 10.

[0352] A stepped indexing mechanism 1476 ensures that each selected level corresponds to a reproducible compression distance of the spring 1470, thereby guaranteeing consistenttherapeutic pulse amplitude across repeated activations. In the embodiment of the figure 15, the stepped indexing mechanism 1476 is configured for displacing the sub-assembly comprising the main piston actuation element 1430 and the amplitude selector 1475 with respect to the cylindrical chamber 215. This provides discrete preload levels of pressure in the cylindrical chamber 215. For example, the stepped indexing mechanism 1476 is configured for applying a constant offset pressure on the liquid in the cylindrical chamber 215.

[0353] In certain embodiments, the energy storage and release mechanism further comprises a half-tooth gear mechanism 840.

[0354] The half-tooth gear mechanism 840 can be configured to:

[0355] • gradually engage and store mechanical energy during spring compression, and

[0356] • suddenly disengage upon reaching a predefined release threshold.

[0357] The sudden disengagement may cause rapid decompression of the spring 1470, driving the therapeutic piston assembly 1465 to generate a transient high-pressure pulse within the inflation liquid.

[0358] The geometry of the half-tooth engagement may be configured to permit a predefined number of impulses per rotation or per compression cycle, ensuring reproducible pulse frequency.

[0359] Release of the stored mechanical energy can be triggered by the release actuator 1450, which in one embodiment comprises a first button (for example a blue button).

[0360] Actuation of the release actuator causes instantaneous disengagement of the spring-retaining mechanism.

[0361] The module may further comprise a measurement actuator 1460, which in one embodiment comprises a second button (for example a red button). The measurement actuator can be configured to activate or reset pressure-volume monitoring prior to or during therapeutic delivery.

[0362] The separation of charging, release, and measurement functions enhances operator control and procedural safety.

[0363] Importantly, the therapeutic piston assembly may operate relative to a constant activation reference volume.The geometry of the therapeutic piston and its fluid coupling may be configured such that generation of pressure oscillations does not produce net displacement of inflation liquid relative to the baseline volume established by the main piston 210.

[0364] Accordingly:

[0365] • shock pulses are generated in a volume-neutral manner,

[0366] • balloon inflation diameter is preserved during pulse delivery,

[0367] • and unintended overinflation is avoided.

[0368] This purely mechanical configuration provides:

[0369] • operation independent of electronic components or external power sources;

[0370] • reproducible amplitude-controlled shock generation;

[0371] • predefined selectable therapeutic levels;

[0372] • safe impulse delivery within preset pressure limits;

[0373] • mechanical fallback capability in case of electronic failure;

[0374] • compatibility with disposable or semi-disposable implementations;

[0375] • precise and repeatable manual therapeutic control.

[0376] The mechanical amplitude selector combined with indexed spring preload ensures that therapeutic pulses remain consistent across multiple activations and between operators.

[0377] This embodiment is particularly advantageous in interventional environments requiring tactile control, robustness, and procedural independence from external control systems.Here is a simple table with reference numbers and corresponding features:

[0378] Reference Feature Description

[0379] Number

[0380] 10 Inflatable balloon

[0381] 100 System for guided balloon therapy in interventional cardiology 110, 510, 1010 Main piston for liquid displacement and inflation control

[0382] 115, 515, 1015 First liquid reservoir for supplying inflation fluid, e.g. first chamber for inflation fluid and cavitation zone

[0383] 120, 520, 1020 Second piston for therapeutic interventions such as shockwave therapy 125, 525, 1015 Second liquid reservoir for therapeutic agents or additional fluid 130, 1030 Purge piston for air removal and liquid recirculation

[0384] 135, 1035 Third liquid reservoir for air removal and fluid recirculation, e.g. purge chamber for air removal and fluid recirculation

[0385] 145 Fourth liquid reservoir for additional fluid supply or therapeutic agents 150 Colibri Connector for fluid management and air removal

[0386] 152 Coaxial Luer lock system integrated into the Colibri Connector 155 Catheter for delivering liquid into the inflatable balloon

[0387] 156, 166 Outer (or inner) lumen for liquid delivery

[0388] 158, 164 Inner (or outer) lumen for air aspiration

[0389] 160 Connector between the fourth reservoir and the first / second reservoirs 162 Connector between the fourth reservoir and the third reservoir 165 Coaxial tubing for bidirectional fluid movement

[0390] 500, 1000 Manual indeflator for precise inflation and therapy control

[0391] 560 Turning knob for operating the main piston in the manual indeflator 570 Syringe assembly containing predefined liquid volume

[0392] 580 Trigger mechanism with multiple control states

[0393] 685 Rotary encoder for absolute volume measurement

[0394] 690 Wireless communication module for real-time data transmission 700 Display unit for visualizing pressure-volume curves and therapy parameters

[0395] 830 Spring mechanism for controlled shockwave generation

[0396]

[0397] 840 Half-tooth gear mechanism for regulated mechanical energy release 1150 Disposable cassette containing liquid reservoirs and pistons for robotic system

[0398] 1160 Robotic unit configured to connect to the disposable cassette

[0399] 1200 Robotic system for automated inflation, therapy, and air removal 1220 Robotic processor for monitoring P / V curves and controlling therapy delivery

[0400] 1250 Pressure sensor integrated into the fluid pathway for real-time monitoring 1650 Handheld controller for manual activation of pistons and therapeutic interventions

[0401] Ref. No. Feature Description

[0402] 210 Inclined piston

[0403] 212 Lateral purge slot

[0404] 213 Overflow path

[0405] 215 Cylindrical chamber

[0406] 1400 Ergonomic handle

[0407] 1420 Liquid outlet

[0408] 1430 Main piston actuation element

[0409] 1450 Release actuator (blue button)

[0410] 1460 Measurement actuator (red button)

[0411] 1465 Therapeutic piston assembly

[0412] 1470 Compression spring

[0413] 1475 Amplitude selector

[0414] 1476 Indexing mechanism

[0415]

[0416] The present invention encompasses various embodiments that can be implemented separately or in combination. The invention is defined by the claims, but additional support is provided by the following clauses, which outline different inventive aspects:Aspects of the Invention (Structured as Clauses)

[0417] The present invention encompasses various embodiments that can be implemented separately or in combination. The following clauses provide additional support for various aspects of the invention:

[0418] 1. A method for inflating an inflatable balloon (10) within a blood vessel of a patient using a guided balloon therapy system, the method comprising at least one of:

[0419] o (a) Providing a system for guided balloon therapy, the system comprising:

[0420] ■ A main piston (110, 510, 1010) fluidly connected to a first liquid reservoir (115, 515, 1015) and an inflatable balloon (10) via a catheter (155) locked in a Colibri Connector (150);

[0421] ■ A second piston (120, 520, 1020) fluidly connected to a second liquid reservoir (125, 525, 1015) for delivering therapeutic interventions; ■ A purge piston (130, 1030) fluidly connected to a third liquid reservoir (135, 1035) for air removal; and

[0422] ■ A processor configured to analyze pressure-volume (P / V) curves in real time and adjust inflation parameters accordingly.

[0423] o (b) Priming the system by actuating the purge piston (130, 1030) to remove residual air from the balloon (10), directing air and liquid back to the third liquid reservoir (135, 1035) via the Colibri Connector (150).

[0424] o (c) Inflating the balloon (10) by actuating the main piston (110, 510, 1010), moving liquid from the first liquid reservoir (115, 515, 1015) into the balloon (10) while continuously monitoring real-time pressure and volume data. o (d) Adjusting inflation parameters dynamically based on detected P / V characteristics, wherein:

[0425] ■ The processor detects abrupt pressure changes, indicating possible vessel resistance or calcifications.

[0426] ■ If calcifications are detected, the processor adjusts the inflation sequence to apply gradual inflation pressure or initiate shockwave therapy.

[0427] o (e) Delivering therapeutic intervention, wherein:■ If therapeutic intervention is required, the second piston (120, 520, 1020) moves liquid from the second liquid reservoir (125, 525, 1015) into the balloon (10).

[0428] ■ The second piston is actuated to generate targeted pressure waves, shockwaves, or acoustic waves for calcification treatment or vessel compliance modulation.

[0429] o (f) Maintaining volume neutrality during therapy, wherein:

[0430] ■ The purge piston (130, 1030) operates in coordination with the second piston (120, 520, 1020) to maintain a constant fluid volume while generating controlled pressure oscillations inside the balloon (10). o (g) Completing the procedure, wherein:

[0431] ■ The processor analyzes final P / V data to confirm adequate vessel dilation.

[0432] ■ The balloon (10) is deflated by reversing the main piston (110, 510, 1010), returning liquid to the first liquid reservoir (115, 515, 1015). ■ The purge piston (130, 1030) is optionally actuated to remove remaining fluid and air, ensuring a controlled deflation. o (h) Providing procedural feedback, wherein:

[0433] ■ The processor transmits real-time inflation data to a display unit (700).

[0434] ■ The operator receives visual and / or tactile feedback via the handheld controller (1650) regarding balloon behavior and vessel response.

[0435] A manual indeflator (1000) for controlled inflation and therapeutic intervention in an inflatable balloon (10) within a blood vessel, the manual indeflator comprising at least one of:

[0436] o A main piston (510, 1010) configured to move liquid from a first liquid reservoir (1015) to the inflatable balloon (10) via a catheter (155);

[0437] o A second piston (120, 520,1020) positioned within the main piston (510,

[0438] 1010), configured to generate therapeutic interventions in the form of pressure waves, shockwaves, or acoustic waves;

[0439] o A trigger mechanism (580) configured to control the actuation of the main piston (510, 1010) and the second piston (520, 1020), allowing precise fluid delivery and therapy application;o A turning knob (560) connected to a gearbox and a rotary encoder (685), wherein rotation of the knob (560) actuates the main piston (510, 1010) via a rack-and-pinion mechanism, ensuring controlled displacement of liquid; o A linear encoder (618) configured to measure the absolute volume of fluid delivered based on piston displacement;

[0440] o A pressure sensor (1250) integrated within the fluid pathway, configured to continuously monitor real-time pressure variations and provide feedback for therapeutic interventions; and

[0441] o A wireless communication module (690) integrated within the handle, configured to transmit real-time pressure-volume (P / V) data to an external display unit (700) for procedural monitoring and operator feedback.

[0442] 3. A disposable cassette (1150) for use with a robotic system (1200) for balloon inflation and therapy delivery, the cassette comprising at least one of:

[0443] o A first liquid reservoir (1015) for supplying inflation fluid to an inflatable balloon (10);

[0444] o A second liquid reservoir (1015) for storing therapeutic agents or additional fluid;

[0445] o A third liquid reservoir (1035) for air removal and recirculation;

[0446] o A fluid interface configured to connect to a Colibri Connector (150) for bidirectional fluid management, including liquid delivery and air aspiration; o A piston interface area (1160) configured to engage with robotic actuators, allowing for precise control of piston movements within the cassette; and o A sealed structure to maintain sterility and prevent cross-contamination during procedures.

[0447] 4. A robotic system (1200) for automated inflation, therapeutic intervention, and air removal in an inflatable balloon (10), the system comprising at least one of:

[0448] o A processor (1220) configured to:

[0449] ■ Monitor and analyze real-time pressure-volume (P / V) curves;

[0450] ■ Control fluid delivery, therapeutic interventions, and air purging dynamically based on vessel compliance and detected deviations in P / V relationships;■ Adjust inflation sequences automatically based on detected calcifications or vessel stiffness.

[0451] o A display unit (700) configured to present real-time P / V curves, inflation pressure, liquid volume, and therapy parameters.

[0452] o A plurality of piston actuators configured to engage with a disposable cassette (1150), the cassette (1150) comprising:

[0453] ■ A first liquid reservoir (1015) for inflation fluid;

[0454] ■ A second liquid reservoir (1015, 525) for therapeutic agents;

[0455] ■ A third liquid reservoir (1035) for air removal;

[0456] ■ A fluid interface configured to connect to a Colibri Connector (150) for liquid injection and air aspiration;

[0457] ■ A robotic interface area (1160) configured to operatively connect the cassette (1150) to the robotic system (1200), enabling automated fluid management.

[0458] o A handheld controller (1650) configured to:

[0459] ■ Manually activate the main piston (1010) for controlled fluid delivery;

[0460] ■ Activate the second piston (1020) to deliver therapeutic interventions such as shockwaves or drug delivery;

[0461] ■ Provide tactile feedback indicative of vessel compliance and calcification detection.

[0462] o A wireless communication module (690) configured to transmit real-time procedural data to external monitoring systems for enhanced precision and operator feedback.

[0463] For the purpose of clarity and a concise description, features are described herein as part of the same or separate embodiments. However, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described.

[0464] For example, while embodiments were shown for a manual indeflator, a robotic-assisted system, and a cassette-based fluid management system, alternative ways may be envisaged by those skilled in the art having the benefit of the present disclosure for achieving a similar function and result.E.g., the main piston and the therapy piston may be combined into a single integrated unit, or the purge mechanism may be split into multiple stages for enhanced fluid control. The various elements of the embodiments as discussed and shown offer certain advantages, such as improved precision in pressure-volume monitoring, enhanced therapeutic delivery, and more efficient air removal.

[0465] Of course, it is to be appreciated that any one of the above embodiments or processes may be combined with one or more other embodiments or processes to provide even further improvements in fluid control, therapeutic efficiency, and operator feedback.

[0466] It is appreciated that this disclosure offers particular advantages to interventional cardiology procedures, particularly in angioplasty, vessel preparation, and treatment of calcified lesions and, in general, can be applied for any application wherein controlled fluid displacement, pressure modulation, or automated therapeutic intervention is required.

[0467] It will be understood by a person skilled in the art that the various features and elements described in the different embodiments of the present invention are not limited to any single embodiment but may be combined or interchanged in different configurations, as appropriate for a given application. Unless explicitly stated otherwise, no feature is restricted to a particular embodiment, and all described components, functionalities, and configurations may be adapted, substituted, or integrated into other embodiments without departing from the scope of the invention. The disclosed system is intended to be flexible and modular, allowing for variations and modifications that would be evident to a skilled person based on the teachings provided herein.

[0468] In interpreting the appended claims, it should be understood that the word "comprising" does not exclude the presence of other elements or acts than those listed in a given claim; the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements; any reference signs in the claims do not limit their scope; several "means" may be represented by the same or different item(s) or implemented structure or function; any of the disclosed devices or portions thereof may be combined together or separated into further portions unless specifically stated otherwise. Where one claim refers to another claim, this may indicate synergetic advantage achieved by the combination of their respective features. But the mere fact that certain measures are recited in mutually differentclaims does not indicate that a combination of these measures cannot also be used to advantage. The present embodiments may thus include all working combinations of the claims wherein each claim can in principle refer to any preceding claim unless clearly excluded by context.

Claims

54CLAIMS1. A system for guided balloon therapy in interventional cardiology (100), configured to insert and operate an inflatable balloon (10) within a blood vessel of a patient, the system comprising:- means to measure the pressure and volume of the balloon (10) in real time during balloon inflation;- a main piston (110, 510, 1010) configured to move liquid from a first liquid reservoir (115, 515, 1015) to the inflatable balloon (10), to inject liquid into the inflatable balloon (10) through a catheter (155), and to inflate the balloon (10) under closed-loop control based on real-time analysis of pressure-volume (P / V) curve evolution, wherein the pressure-volume relationship is used as an active control parameter for dynamically adjusting piston actuation; and- a second piston (120, 520, 1020) configured to move liquid from a second liquid reservoir (125, 525, 1015) to the inflatable balloon (10), and to deliver therapeutic interventions by actuation of the second piston in response to detected non-linearities, discontinuities, or compliance variations in the realtime pressure-volume curve.

2. The system according to claim 1, wherein the main piston and the second piston are configured to operate under functional separation, the main piston being dedicated to inflation volume control and the second piston being dedicated exclusively to therapeutic pulse generation without altering net inflation volume.

3. The system according to claim 1 or 2, wherein the catheter is locked in a Colibri Connector (150), and wherein the system further comprises a purge piston (130, 1030) configured to move liquid from a third liquid reservoir (135, 1035) to the inflatable balloon (10), to purge residual air from the inflatable balloon (10), and to direct purged air and liquid back to the third liquid reservoir (135, 1035), the Colibri Connector (150) comprising a coaxial Luer lock system (152) including an outer lumen (156, 166) configured for liquid delivery and an inner55lumen (158, 164) configured for air aspiration, the outer lumen being fluidly connected to the first and second liquid reservoirs and the inner lumen being fluidly connected to the third liquid reservoir.

4. The system according to any of claims 1 to 3, wherein the second liquid reservoir (125, 525, 1015) and the first liquid reservoir (115, 515, 1015) are the same.

5. The system according to any of claims 1 to 4, further comprising a fourth liquid reservoir (145) connected to at least one of the first, second, and third liquid reservoirs.

6. The system according to any of claims 1 to 5, wherein the main piston, the second piston, and the first and second liquid reservoirs are provided by a manual indeflator (500, 1000).

7. The system according to any of the preceding claims, wherein the main piston (210) is arranged with a predefined inclination relative to a longitudinal axis (L) of a cylindrical chamber (215) and comprises at least one lateral purge opening (212) positioned at an upper region of the inclined piston such that residual gas accumulates toward the purge opening during piston advancement.

8. The system according to claim 7, wherein excess liquid migrates above the inclined piston along an overflow path (213) and is hydraulically excluded from an active inflation volume.

9. The system according to any of the preceding claims, wherein the system comprises an ergonomic handle (1400) configured to promote a substantially vertical operating orientation of the cylindrical chamber (215) such that gas rises toward a purge region during use and liquid is delivered from a lower outlet (1420).

10. The system according to any of claims 1 to 9, wherein the second piston (120, 520) is inserted inside the main piston (110, 510).

11. The system according to any of claims 1 to 10, wherein the second piston (120, 520, 1020) is operatively coupled to a mechanical energy storage element comprising at least one spring (522, 1470), the spring being configured to store56mechanical energy during a charging phase and to release the stored energy to generate a therapeutic pressure pulse.

12. The system according to claim 11, further comprising a mechanical adjustment mechanism (1475) configured to define selectable preload levels of the spring (522, 1470).

13. The system according to claim 12, wherein the mechanical adjustment mechanism comprises a stepped indexing mechanism (1476) configured to provide discrete preload levels.

14. The system according to any of claims 11 to 13, wherein the spring (522, 1470) is associated with a controlled release mechanism (840) configured to permit gradual energy accumulation and rapid release of stored energy to produce a transient pressure impulse.

15. The system according to any of the preceding claims, wherein therapeutic actuation of the second piston (120, 520, 1020) is performed relative to a substantially constant activation reference volume such that pressure oscillations are generated without net displacement of inflation liquid.

16. The system according to any of claims 11 to 15, wherein the second piston is configured to generate acoustic waves by rapid oscillatory movement.

17. The system according to any of claims 11 to 16, wherein the second piston (120, 520) further comprises a toothed engagement mechanism (840) configured to gradually store mechanical energy through engagement of interlocking teeth and to suddenly disengage to produce a controlled impulse.

18. The system according to any of the preceding claims, further comprising a processor configured to receive the pressure and volume measurements in real time.

19. The system according to claim 18, wherein the processor is configured to monitor and analyze real-time pressure-volume curves and to control fluid delivery and / or therapeutic interventions based on deviations in the pressurevolume curves.5720. The system according to claim 18 or 19, further comprising a display unit (700) configured to visually present real-time pressure-volume curves.

21. The system according to any of the preceding claims, wherein the main piston (1010), the second piston (1020), and the purge piston (130, 1030) are provided by a robotic system configured to operatively connect to a disposable cassette (1150).

22. The system according to claim 21, wherein the robotic system comprises an automated calibration function configured to adjust piston actuation profiles based on detected variations in catheter resistance.

23. The system according to claim 21 or 22, further comprising a handheld controller (1650) configured to control the main piston and to activate the second piston.

24. The system according to claim 23, wherein the handheld controller further comprises tactile feedback indicative of resistance encountered during balloon inflation and / or deviations in pressure-volume curves.

25. The system according to any of the preceding claims, further comprising a second purge mechanism operating in coordination with the purge piston to maintain a neutral system volume and / or generate controlled pressure waves.

26. The system according to any of the preceding claims, wherein the first liquid reservoir comprises a cavitation zone (1060) configured to accelerate fluid flow for generating cavitation bubbles.

27. The system according to any of the preceding claims, further comprising an identification module configured to detect and retrieve parameters of the inflatable balloon (10).

28. A Colibri Connector (150) configured to integrate with the system of any of claims 1 to 27, the Colibri Connector comprising a coaxial Luer lock system (152) including an outer lumen for liquid delivery and an inner lumen for air aspiration.

29. The Colibri Connector according to claim 28, further comprising an adaptive- length mechanism.

30. The Colibri Connector according to claim 28 or 29, further comprising a solidcore shaft mechanism.

31. A manual inflation module for inflating an inflatable balloon (10), comprising:- a cylindrical chamber (215) containing inflation liquid;- a piston (210) slidably arranged within the chamber, the piston being arranged at an inclination relative to a longitudinal axis of the chamber and comprising at least one lateral purge opening (212); and-an ergonomic handle (1400) configured to promote a substantially vertical operating orientation of the chamber,whereby residual air is automatically evacuated and a predefined initial liquid volume is reproducibly maintained.

32. The manual inflation module according to claim 31, wherein excess liquid migrates above the piston and is hydraulically excluded from an active inflation volume.

33. The manual inflation module according to claim 31 or 32, further comprising manual actuation elements including a piston actuation element, a therapeutic charging element, a release actuator, and a measurement actuator.

34. The manual inflation module according to any of claims 31 to 33, wherein therapeutic pulse amplitude is manually adjustable by selectable preload levels.

35. The system according to any of claims 1 to 27, wherein the main piston is provided by a manual inflation module according to any of claims 31 to 34.

36. A method for preparing an inflatable balloon, comprising holding a manual inflation module in a substantially vertical orientation, advancing an inclined piston within a chamber containing liquid, evacuating residual air through a lateral purge opening prior to balloon inflation, and delivering a predefined air- free liquid volume to the balloon.

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