Worrell Design, Inc.
Heart valves are held in place with string-like tendons that can often stretch or break leading to serious heart conditions. Before the NeoChord DS1000, surgeons had to put the heart on bypass to manually place sutures in a very invasive and dangerous procedure. The DS1000 is a single-use, hand-held solution for a minimally invasive technique to repair a damaged heart valve on a beating heart through a small incision. The device consists of an ergonomic handle with a clamping tip that grabs the damaged valve. Fiber optics in the DS1000 confirm the placement before a preloaded surgical suture is deployed.2. The Brief: Summarize the problem you set out to solve. What was the context for the project, and what was the challenge posed to you?
Many patients suffer from the symptoms and long-term effects of mitral valve regurgitation because their symptoms are too minimal to justify the invasive procedure or their symptoms are too severe and the procedure would be too dangerous. Traditional repair requires a 3-10 inch chest incision, cutting through the sternum, opening the rib cage, stopping the heart, and placing the patient on bypass while the surgeon manually places a suture to act as an artificial tendon. Due to the seriousness of the procedure, approximately only 20% of the 250,000 Americans with mitral valve regurgitation get treatment, creating a need for a minimally invasive solution for repair. The NeoChord technology is a novel surgical technique that was developed by cardiac surgeons at the Mayo Clinc. The first proof of concept prototype was made from stainless steel, which caused shadowing under imaging and provided the surgeon with little tactile feedback. The instrument was complex to use, uncomfortable to operate, and expensive to produce. The early device connected to an external monitor to validate placement requiring surgery centers to invest in capital equipment. The challenge was to take the Mayo Clinic concept and develop a low-cost, disposable design solution that was commercially viable. The design team had to improve ergonomics and feel for the surgeon, reduce per unit costs, and allow one device to deploy multiple sutures should a valve repair require more than one suture. The system needed to be self-contained in one package and able to be shipped pre sterilized.3. The Intent: What point of view did you bring to the project, and were there additional criteria that you added to the brief?
The NeoChord technique was developed in a clinical setting and licensed to an entity that was formed to build a business. We were the product development team that took the proof of concept prototype and made it into a marketable product. Our team consisted of ethnographic researchers, industrial designers, engineers, graphic designers, and prototyping specialists. Our ethnographic research identified unnecessary steps to the surgical procedure that design solutions were able to eliminate. Our team developed a simple, low-cost monitor utilizing built in fiber optics that eliminated the need to interface with an external display. The tip design was crucial in improving surgeon accuracy and simplifying the procedure. The canted, or angular, tip design of the final product deploys a suture with a simple and intuitive push and pull motion. The technology from Mayo Clinic did effectively prove the minimally invasive technique but was not commercially viable. Our research, design, and engineering capabilities led to a low-cost, disposable solution utilizing plastics that were engineered to withstand the forces of surgery while maintaining tight tolerances for all functional requirements.4. The Process: Describe the rigor that informed your project. (Research, ethnography, subject matter experts, materials exploration, technology, iteration, testing, etc., as applicable.) What stakeholder interests did you consider? (Audience, business, organization, labor, manufacturing, distribution, etc., as applicable)
The project began with Dr. Giovanni Speziali and Dr. Richard Daly from the Mayo Clinic in Rochester, MN. We worked closely with them and used ethnographic research methods to gain a deep understanding of the physiology of the disease and the minimally invasive surgical technique they had developed to treat it. The team met with patients to gain empathy for the end user and the impact this procedure could have on them. A multidisciplinary team of researchers, designers, and engineers developed early concepts that were prototyped in house and tested for ergonomics and surgeon preferences. This process was highly interactive and iterative. Engineers took refined design concepts and created individual components for assembly and production. Materials exploration, performance attributes, disposability, and manufacturability were important considerations to keep the device low-cost. Usability testing was performed on two functional prototypes to verify initial design, performance, materials and assembly intent. Feedback from usability testing and surgeon observations lead to further revisions and improvements to the device, such as using injection molded plastic to achieve tactile feedback during surgery, while also lowering costs. An exchangeable cartridge was the solution for a disposable device that can place multiple sutures on one patient. The Leaflet Capture Verification Monitor allows the surgeon to confirm the proper capture of the leaflet without connecting to any external monitors and it can be easily placed in the surgeon’s line of vision to optimize operating room efficiency. The DS1000 was created to benefit the surgeon, patient, NeoChord, Inc., and the health care industry broadly. Our main objective was to create a simple to use, highly effective and reliable device for the surgeon, to ultimately lead to improved patient outcomes. We created a low-cost disposable device that was all-inclusive improving the sales potential for the exclusive NeoChord system. With a reliable minimally invasive procedure as an option, hospitals can treat more patients with minimal risk, leading to higher profitability. All stakeholders benefit but the patient receives the greatest benefit with reduced risk from surgery, less scaring, a shorter hospital stay, and faster recovery time.5. The Value: How does your project earn its keep in the world? What is its value? What is its impact? (Social, educational, economic, paradigm-shifting, sustainable, environmental, cultural, gladdening, etc.)
An estimated 4 million people in the United States have significant (>2+) Mitral Valve Regurgitation, with an annual incidence of 250,000 newly diagnosed patients. The NeoChord DS1000 creates a significantly less invasive surgery to treat a wider range of affected patients. Approximately 80% of the 250,000 Americans diagnosed do not get treatment because they have minimal or no symptoms. The American Heart Association has recently updated their guidelines to recommend mitral valve repair if the patient presents no symptoms because harmful effects on the heart have already occurred and waiting for symptoms to develop puts the patient at a higher risk. NeoChord brings these asymptomatic or early stage patients a less invasive option for repair for improved quality of life. Offering a minimally invasive procedure before symptoms develop improves the delivery of healthcare through decreased risk of stroke, fewer complications, lower infection rate, and a shorter recovery period. The device introduces a new surgical technique, in turn broadening the capabilities of Cardiac Surgeons by providing an opportunity to change traditional medical practices for mitral valve regurgitation. The NeoChord surgical method is predicted to reduce hospital stays for mitral valve, in turn increasing patient throughput, which will represent a profit opportunity for hospitals. NeoChord DS1000 provides a solution for treatment for a population of patients in need of a minimally invasive surgery and NeoChord, Inc. has exclusive right to this surgery, representing a large value to our client.