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.
Solutions Offered at Salt Medical
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.