Design and Development of Atherectomy Device

Background

Peripheral artery disease (PAD) is a common circulatory condition where narrowed or blocked arteries reduce blood flow to the limbs, often due to the build-up of fatty deposits or calcified plaque (calcium lesions). Atherectomy, a procedure involving the removal of this plaque, is an essential treatment for PAD. The challenge lies in the precision required to remove calcified plaque without damaging healthy tissue, and the ability to do so in an efficient, reliable manner using specialized atherectomy devices.
Fontierz was approached by a leading medical device manufacturer to assist in the design and development of an advanced atherectomy device, capable of performing orbital and rotational plaque removal. The device needed to meet strict regulatory standards, be durable in the challenging operating environment, and offer optimal performance under demanding conditions.

Challenges Faced

1. Precision and Control in Challenging Environments
The primary challenge was ensuring the atherectomy device could cut and grind through calcified plaque (calcium lesions) without damaging the arterial walls or causing undue harm to surrounding tissue. This required a high degree of precision and control in the motion system of the device, which needed to operate in a small, confined, and highly sensitive environment.

2. High-Speed, Reliable Motor Integration
The motor used in the device had to deliver high-speed rotation and precision while maintaining power density and reliability. Given the demanding nature of atherectomy procedures, the motor needed to operate without failure, even in the presence of challenging conditions such as fluid exposure, vibration, and high operational temperatures.

3. Miniaturization and Ergonomics
The device needed to be compact, lightweight, and easy for clinicians to use, ensuring it could be maneuvered with precision during minimally invasive procedures. The challenge was to design the components to be small and ergonomic without compromising functionality or durability.

4. Compliance with Regulatory Standards
Meeting the rigorous medical device standards for safety, performance, and sterility was critical. The device had to comply with ISO 13485, FDA regulations, and other healthcare standards, including ensuring the materials used could withstand sterilization processes like autoclaving and exposure to corrosive chemicals (e.g., saline and Cidex).

Solution: Fontierz Approach to Overcoming Challenges

1. Innovative Motion Control Systems
Fontierz leveraged its expertise in motion solutions to design a high-precision, high-performance motion control system for the atherectomy device. By integrating advanced motion controllers and custom firmware, we ensured the device could precisely grind or cut through calcified plaque with minimal vibration and optimal efficiency. This approach allowed the device to provide the necessary power to tackle tough calcium lesions while preserving surrounding tissue.

2. Brushless DC Motor Technology
To address the motor requirements, Fontierz developed the 16 mm Ultra EC Brushless DC Motor, which offered unparalleled speed and power density. This motor was critical in providing the high-speed rotation needed for plaque removal while maintaining reliability in a compact form factor. The motor was also designed to operate in harsh medical environments, ensuring durability during the repeated sterilization cycles required for clinical use.

3. Miniaturization and Ergonomic Design
Fontierz’s design team focused on creating a device that was both compact and ergonomically designed, ensuring ease of use for clinicians during delicate procedures. The miniaturized components did not compromise the performance of the atherectomy device, making it possible for healthcare providers to carry out precision procedures in tight and challenging environments.

4. Rigorous Testing and Validation
Fontierz conducted comprehensive testing to ensure the device met both functional and safety requirements. We validated the performance of the motor, motion control system, and device ergonomics through extensive simulations and in-lab testing. Additionally, we rigorously tested the materials used in the device to ensure they could withstand sterilization methods and the exposure to harsh chemicals like saline, Cidex, and formalin.

5. Regulatory Compliance and Documentation
Fontierz worked closely with the client to ensure that all design and development processes adhered to the necessary regulatory frameworks. We supported the documentation process, ensuring that the device met FDA, ISO 13485, and CE standards, including biocompatibility and quality management system (QMS) requirements.

Outcome and Results

By overcoming these significant challenges, Fontierz successfully delivered a state-of-the-art atherectomy device that met the client’s stringent requirements. The device offered:

Precision and Reliability: A high-speed, reliable motor with advanced motion control, ensuring the precise removal of calcified plaque without damage to surrounding tissue.

Ergonomics: A compact, lightweight design that made the device easy to handle and maneuver during complex, minimally invasive procedures.

Durability: The device was able to withstand harsh sterilization processes and the demanding clinical environment.

Compliance: Full adherence to regulatory standards, ensuring that the device could be marketed and used globally.

The successful design and development of this atherectomy device resulted in an effective solution for treating PAD and significantly improved patient outcomes. Fontierz’s collaboration with the medical device manufacturer helped them bring a high-quality product to market that met the needs of both clinicians and patients.

Conclusion

This case study highlights Fontierz’s ability to solve complex challenges in the medical device domain. Our innovative approach to motion systems, component miniaturization, and regulatory compliance helped our client bring a cutting-edge atherectomy device to market. By combining deep technical expertise and a patient-centric focus, Fontierz continues to provide impactful solutions in the medical device industry.

Why FONTIERZ?

Fontierz has successfully worked in the past on various medical projects and product designs. Fontierz’s diverse background in technology, industry, and processes allow us to bring the best practices from many areas. We deliver solutions not available from singularly-focused organizations. Further, we offer:

• Our in-house engineering team has the full range of expertise required for the project including Medical electronics design, firmware development, PC software tool development, and production testing.
• Fontierz has designed systems involving motor control, closed-loop (PID) control, lithium-ion batteries, and medical regulation compliance.
• Fontierz has experience writing low level embedded firmware for 3 phase BLDC motors for both medical and industrial applications
• Fontierz has worked with manufacturers of medical equipment and has developed custom firmware for a custom driver used in medical devices for Orthopedic and arthroscopic surgeries
• Fontierz has developed the following products – Arthroscopic shaver, High Speed spine systems, Orthopedic drill/saw & reamers, Micro drills/saws, Dermatomes, Motion & control electronics for Medical applications and Motion solutions for Aerospace and defense applications
• Fontietz & team has a history of implementing complex motion control solutions involving DC brushless servo motors and control electronics
• Fontierz has developed the control electronics and motion solution for 2k to 80k rpm with no vibration and heating
• Fontierz has expertise in Medical regulatory and design aspects to ensure compliance to various requirements like EN ISO 13485:2016, EN ISO 14971:2019, EN ISO 15223-1:2021, EN 62366-1:2015 + AC:2015 + AC:2016 + A1:2020, EN ISO 17665-1:2006, ISO 20417:2021, IEC 60601-1 :2005+AMD1: : 2012+AMD2:2020, IEC 60601-1-2-2014, IEC 62304:2006+A1:2015, ISO 10993-1:2018