Flexible Electrode Balloons for More Stable Energy Delivery: Intelligent Catheter Design and Process
Balloons are one of the few most commonly used consumables in interventional procedures, and their main uses include:
Vascular/luminal dilation: e.g. PTCA and PTA balloons for direct dilation of the lesion area using balloons, anterior and posterior dilation balloons for stent/valve procedures;
Vessel/lumen sealing: e.g. temporary sealing of the ureter to prevent stone escape in lithotripsy procedures, temporary sealing of vessels to prevent embolus escape in TACE procedures;
Device delivery: e.g. using balloon catheters to deliver implants such as stents and valves;
With the high-speed development of smart catheters, the characteristics of balloons make it easier to fit stably in specific lesions and assist in energy delivery, so they are increasingly used, such as cryo-balloon catheters for treating atrial fibrillation and renal artery ablation balloon catheters for treating hypertension.
And when the sensor/transducer is designed on the surface of the balloon, no matter it is for temperature and pressure measurement or energy ablation, because it can be more stably close to the target site, its application will be more enhanced, such as cardiac surgery, urological surgery, ENT surgery, neurosurgery, gynaecological surgery and so on. However, at the same time, the design and process of catheters, balloons, and electrodes also pose greater challenges.
Requirements for sensors/transducers
Biocompatibility & Sterilisation Compatibility: The material must meet the biocompatibility and stand up to disinfection and sterilisation methods.
Compliance: Sensors/transducers need to comply with medical device regulations and industry standards, ISO standards.
Protection and durability: Must be able to withstand external interference encountered during surgery, such as the use of coatings or housings.
Size and shape: small, thin and flexible to ensure smooth access to the target lesion with minimal trauma.
Sensitivity and range: the delay should be short to allow real-time measurements; the sensitivity should be high to detect small changes, and the range should be large to allow monitoring under various physiological conditions.
Transmission reliability: stable signal/energy transmission with external devices, wired/wireless solutions, wireless solutions need to consider power consumption and battery life.
Requirements for balloon catheters
Overall design: The choice of catheter size, lumen design, lead wire connection, electrode distribution, capsule compliance, coating protection, braiding and other enhancement processes is an overall one, requiring comprehensive decision-making on clinical needs and engineering realisability.
Multi-lumen tube and tip processing technology: Multi-lumen tube is the cornerstone of the catheter, which needs to meet the smooth passage of guidewires, wires, water and other mating devices, and at the same time to ensure that the minimum size of the multi-lumen tube and the catheter tip design and processing of the catheter are determined by the catheter's traceability.
Capsule processing technology: the balloon of the energy delivery catheter is generally compliant, whether it is delivering devices or bonding electrodes to deliver energy, the balloon inflation and deflation time should be as short as possible, and its capsule material in the process of folding and propping up always need to maintain and device/electrode fit, capsule material selection, braiding and other enhancement of the process of choosing the process of processing stability are critical.
Electrode layout design and bonding process: due to the interference effect of the electric field between the electrodes, the electrode layout needs to be professionally designed. At the same time, the electrode bonded to the outer surface of the balloon must be a flexible electrode, the bonding process does not affect the performance of the electrode and the balloon, the bonding effect needs to be strong enough.
Coating process: unlike ordinary balloons, the surface of the balloon with flexible electrodes bonded to it is coated with hydrophilic or other coatings, which needs to consider both the resistance of the electrodes and the effectiveness of the coating.
Salt Solutions
Salt Medical has extensive experience in the design, development and manufacture of catheters for a wide range of interventional diagnostic and therapeutic applications. We have the ability to integrate a variety of diagnostic and therapeutic components such as precision braids and coils for catheter reinforcement, adjustable bend technology, and integrated intelligence platforms for delivery, diagnostics, and therapeutics to fulfil a wide range of clinical needs.
Salt's team has assisted a number of RF ablation, cryoablation, ultrasound ablation, and IVUS catheter customers with such tasks as transducer co-development and supply chain management, multi-lumen design and production, balloon capsule design and production, overall catheter design and production, and ancillary delivery system design and production, which has led to the successful entry of a number of products into the clinical and commercialisation stages.
