Lecture 11 : A Collaborative Excellence by Prof. B. Ravi & Prof. B. K. Chakravarthy Part 2

Summary

The script details the development of a 3D-printed knee joint prosthesis, enhancing surgical accuracy through CT scans and CAD simulations. It discusses the transition from casting to machining for manufacturing, rigorous clinical trials involving ethical approvals and government clearances, and the first successful surgeries in India. The collaborative effort between designers, engineers, and medical professionals is highlighted, emphasizing the importance of cross-disciplinary teamwork and government support in achieving medical innovation.

Takeaways

• 🔧 The development of surgical planning software allows for 3D modeling of patient's anatomy from CT scans to plan surgery more accurately.
• 🛠️ Technologies like CAD, kinematic simulation, dynamic simulation, stress simulation, and manufacturing simulation are utilized in the development of knee joints.
• 🏥 Clinical trials are conducted with rigorous protocols, including patient selection criteria, hospital and doctor selection, procedure guidelines, and insurance considerations.
• 👨‍⚕️ Training manuals are created to instruct surgeons on the use of the new prosthesis, ensuring proper implementation during surgery.
• 🏢 The Drugs Controller General of India (DCGI) and hospital Ethical Institutional Committees must approve the clinical trials.
• 📸 Post-surgery, patients are able to walk without crutches within days, indicating the success of the prosthesis.
• 🔄 The prosthesis is designed to allow for a range of motion up to 150 degrees, surpassing the flexibility of some imported knee joints.
• ⚙️ The prosthesis components are customizable and can be mixed and matched to fit different patient needs.
• 📦 The packaging and armamentarium are designed to be user-friendly for doctors, with clear distinctions between 'On table' and 'Off table' tools.
• 👥 A multidisciplinary team, including designers, engineers, and medical professionals, collaborated to develop and refine the prosthesis.
• 🏥 The project was supported by significant funding from the Principal Scientific Advisors Office, reporting directly to the Prime Minister.

Q & A

What is the significance of using 3D models in planning surgeries?

Using 3D models in surgery planning allows for precise cuts and placement, which increases the accuracy and success rate of surgeries.

How does the integration of CAD and simulation contribute to the development of prosthetic joints?

CAD and various simulations, including kinematic, dynamic, and stress simulations, contribute to the precise design and testing of prosthetic joints, ensuring their reliability and functionality.

Why did the team switch from casting to machining processes in manufacturing prosthetic joints?

The team switched from casting to machining processes because they found the casting method to be unreliable in terms of consistency and quality.

What is the role of 3D scanning in the final inspection of prosthetic joints?

3D scanning is used to inspect and compare the manufactured prosthetic joints with the original CAD models to ensure accuracy and quality.

What are the clinical trials mentioned in the script, and why are they important?

Clinical trials refer to the process of testing the prosthetic joints in actual human surgeries. They are important because they validate the effectiveness and safety of the technology in real-world medical applications.

What are the challenges faced in conducting human clinical trials for prosthetic joints?

Challenges include obtaining necessary permissions, developing detailed study protocols, defining patient inclusion and exclusion criteria, and preparing for potential complications and insurance matters.

How does the design team support the surgical team in the operation theater?

The design team supports the surgical team by creating user-friendly armamentarium, designing packaging for easy access to tools, and providing training through mock surgeries using dummies.

Why is the armamentarium and its design important for the surgical process?

The armamentarium, which includes the tools and instruments for fitting the prosthesis, is crucial as it aids the surgical team in efficiently and accurately performing the operation.

What is the significance of the patent-pending design innovation mentioned in the script?

The patent-pending design innovation refers to a unique feature of the prosthetic joint that enhances its functionality and durability, which is a significant advancement in the field of prosthetics.

How does the design team ensure that the packaging and handling of prosthetic components meet medical approval standards?

The design team ensures medical approval by considering usability, packaging, and handling in their design process, creating clear divisions for 'Off table' and 'On table' tools, and providing comprehensive manuals and training for surgeons.

What is the role of the principal scientific advisors office in the development of the prosthetic joint project?

The principal scientific advisors office, reporting directly to the Prime Minister, played a critical role by providing constant support and substantial funding, which was essential for the project's success.