FedDev Ontario`s ARC Initiatives OCAD University Project # 5 – Heal.X
Transcription
FedDev Ontario`s ARC Initiatives OCAD University Project # 5 – Heal.X
FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X How can we design a new casting design and methodology that can revolutionize the way fractures are treated that reduces healing time, reduces muscle atrophy, prevents skin irritations and infections, is waterproof, can be easily removed for medical check-ups, customized to the injury and size of the patient and is affordable? Introduction Casts and splints have been used as immobilizing devices since 15 century BC. Even with the advancement of science and technology, these ancient methods are still used as the preferred method of treatment to immobilize bone fractures. The current treatment for fractures, after ensuring that the bones are aligned, is immobilization of the limb to let the body heal naturally, which can take 4-24 weeks. Current casting systems have negative effects such as muscle atrophy, infection, nerve damage, skin irritation, lack of hygiene, psychological impact, and unpleasant experience for the patient. As well, the patient is required to visit the hospital every other week—a high cost for the hospital and extremely inconvenient for the patient There have been many advancements in the technology of materials suitable for casting. Also, there are no casting systems on the market that can provide the proper support without causing a number of negative effects to the patient which may become long-term disabilities for children and adults. Many of the casting products available, which are not affordable nor are they very effective. One solution to this problem requires attending numerous physiotherapy sessions, which can be time consuming, uncomfortable for patients, and expensive. Ultimately, the results of traditional casts do not ensure full recovery of the injured limb or account for the psychological impact on children. SME HEAL.X wanted to test its research assumptions in actual situations and on real subjects. To support business development, Heal.X sought to acquire skills in strategic planning, business strategy and foresight, and specifically understand the mergence of design thinking and systemic technology solutions. For OCAD University, project HEAL.X presented an opportunity to explore an industrial design, health & wellness product that develops systemic value. Heal.X Innovations was accommodated on campus in the Imagination Catalyst incubation space, which enabled peer to peer networking with other incubator occupants. Heal.X Innovations wanted to access industry collaborators and market intelligence, to support proof of concept development for the project, and protect the resulting intellectual property (IP). Heal.X - June 2013 1 FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X PROJECT BACKGROUND Play is a key aspect of human development. Play is simultaneously calming, relaxing and stimulating for the brain and body. However, unintentional falls are the leading cause of nonfatal injury in children younger than 14 years of age in the United States and Canada. Each year, 2.8 million children are treated in emergency rooms for fall-related injuries such as bone fractures. Although children’s bones have an amazing capacity to heal, broken bones in children must receive appropriate treatment due to frequent growth plate injury. The growth plate is a part of the bone that is actively growing and injuries can cause long-term problems if not appropriately treated. Therefore, doctors watch children closely as they heal. CT SCAN The most common treatment of fractures in children is a simple cast. The most common type of broken bone treated in a cast is called a buckle fracture. There are several side effects that casts cause during the recovery process. Muscle atrophy, infection, nerve damage, and psychological impact can have long term effects on children. CT SCAN RP Image 1: User Scenario Flow Chart Heal.X - June 2013 RP 2 FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X Market Review The current selection of products available range from $20–$1200 for just the cost of immobilization. Additional costs such as physiotherapy are $150– $300 per session with a minimum of 3 sessions to enhance recovery. In Canada the cost of treatment is covered by Health Canada. However, the patient or personal insurance company pays the cost of the casts or splints used. A patient with a fractured bone needs to visit the orthopedic doctor several times to ensure the proper progress of healing. This may take anywhere from 2 to 20 visits, which would be of additional cost to Health Canada. Depending on the injury and the method used to immobilize the injured limb, the patient’s daily routine can suffer and cause a lack of productivity that can cost money and negative psychological impact. Project HEAL.X is the future of casting that will revolutionize the way fractures are treated - with 5 novel ideas that make the system unique. 75mm 200mm 75mm Image 2: Preliminary Prototype Sketch Models75mm 200mm 40mm 200mm 40mm Image 3: Technical Sketch Models Image 4: 3D CAD Experiment Models 40mm Heal.X - June 2013 3 FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X Prototype This example is based on a radial distal fracture (wrist) and HEAL.X first product. he HEAL.X Cast is designed and made up of two T parts that are placed on the wrist based on immobilizations points. The cast immobilization rate is 85%, which is 35% higher than other devices. The cast is formed in a way that immobilizes the whole hand and gives support to ensure the hand is stabilized. Image 5: Process of finding immobilization points Each part is attached to the hand with a silicon based medical adhesive which is breathable, waterproof and can be removable with medical adhesive spray. The design of the splints is inspired by bone structures, which are porous yet very strong. The unique structure of the splint makes it breathable and lighter. The Heal.X cast is customized using a unique system flow. CT-Scan machines are used at the beginning of the diagnosis process, to acquire a 3D Image 6: Final HEAL.X prototype; Final Kit: Attachments with silicone base adhesive model of the injured limb and also a complete series of x-rays to determine the fracture type. emplate software that has a 3D model of the cast T is used to customize the cast to the 3D arm model created by the CT SCAN. he manufacturing of parts is done at the hospital T where a rapid prototyping department would print the cast in medical grade resin with antibacterial properties. Image 7: Final HEAL.X prototype Heal.X - June 2013 4 FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X Benefits OBJECTIVES OF Heal.X The 5 methods used in HEAL.X casting system have many benefits for the patients and the health system. Affordable Affordable for the budgets available to fracture clinics in the United States and Canada. 1. Reduce healing time by allowing the patient to exercise while wearing the cast Customizable Allows the final product to be customized individually ensuring quality treatment and comfortable setting for a child with fractured wrist. 2. R educe the cost for patient and insurance companies by reducing the need for physiotherapy sessions to regain full recovery 3. R eduction in operational cost for hospitals and healthcare systems Image 8: 3D CAD Models of final designs Radiolucent Enables x-rays of the broken part to be taken while wearing the cast. This process should not interrupt the function of a cast. Indication Of Healing Progress A cast design that gives feedback to the user showing the progress rate of healing and as an indicator of time needed to fully recover from a buckle fracture in the wrist. 4. Customized exactly to the body part for maximum comfort and support 5. Waterproof 6. T he structure of the cast is porous, making it lightweight and breathable Breathable Allows air circulation throughout the cast to eliminate problems such as infection and rashes. 7. Easy application and removal method 8. Prevents skin irritation and infection 9. Ease of use while wearing clothing Image 9: Heal.X user benefits Heal.X - June 2013 5 FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X RESEARCH Methods A number of activities were undertaken to complete this research such as, literature reviews, competitive analysis and user hierarchy. During this research, traditional methods of orthopedic bracing were re-evaluated and advanced technologies available in Canada were used to design a new system to prevent side effects, promote healing and reduce the cost for both patient and health care system. The research of bone fracture immobilization started with Mandad Tabrizi’s background in Kinesiology and secondary research. An in-depth review of medical journals and several studies on bone fracture treatments provided insights about the common results for immobilization devices. Furthermore, these insights were evaluated with the help of Dr. Javad Sattarian, Orthopedic Surgeon at the Scarborough Hospital. Out of more than ten reviewed studies that compared the benefits of the cast and splint as a method of immobilization, 85 percent of the studies showed a better recovery rate with the splints. prototypes were made to test the insights from these brainstorming sessions. These findings were then compared with the insights of Dr. Sattarian. Not only did these prototypes allow for a better understanding, they also helped tremendously in the advancements of the Computer Aided Design (CAD) models of the final designs. These designs were then fabricated using Additive Fabrication Technology (AFT) also known as 3D printing. Further information was gained through stakeholder analysis and user experience flow charts. Based on the overall need of the patients and brainstorming sessions with OCAD University Industrial Design thesis advisors, more than 100 The CAD models and the 3D printed prototypes would not have been possible if it were not for OCAD University and FedDev Ontario grant supports. Image 10: Heal.X product customization methods Heal.X - June 2013 6 FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X PROJECT summary injuries are treated from the moment a patient walks into a hospital to the point that the patient fully recovers. The start of this project was based on a sport-related injury. It was through the research process that remarkable potential was found for the use of technology advancements such as 3D scanning and 3D printing in a more elaborate way to treat musculoskeletal injuries and bone fractures. This research also led to a number of new discoveries and data that will be used in the next steps of this research. Results The result of this research project created a solid foundation for future research projects around injuries and the use of technology to design a human friendly solution which, is also sustainable. Heal.X Innovation’s final design is a complete system that customizes a two part brace for immobilization of the injured limb. Its first product is called MANU.X and has been designed for a wrist buckle fracture. Along with MANU.X, a patent pending system has been designed which uses a 3D scanner to obtain an image of the arm and using the Heal.X proprietary software to customize the brace to patient’s size. The customized brace is fabricated by a 3D printer and is secured to a patient’s wrist with a silicone-based medical adhesive, which is waterproof and can last up to a month. Due to the extensive research of this design and the tremendous support from OCAD University and FedDev Ontario, project Heal.X is moving to the next level by strategically entering the orthopedic rehabilitation market. Heal.X project is in its final stages of prototyping and will start clinical testing in early 2014. Process and design of the cast and manufacturing process of the casts have patent pending status in US and Canada. The Patent filing number: 27871 The purpose of this project was not only to design a new product for bracing fractures and sprains but to also design a new platform and system that can fundamentally change the way musculoskeletal Image 11: Final Heal.X prototype Heal.X - June 2013 7 FedDev Ontario’s ARC Initiatives OCAD University Project # 5 – Heal.X Research Team SME Dianne Croteau Principal Investigator, Associate Professor, Faculty of Design, OCAD University Mandad Tabrizi Heal.X Innovation, SME, Founder, Design Strategist Richard Bozzato Ph.D., Life Sciences & Healthcare, MaRS Thomas Gehring Business Development Manager, OCE Pranay Gupta B.Tech (polymer) MBA, U of T Rotman Heal.X Innovation http://healxinnovation.net OCAD University: http://www.ocadu.ca MaRS: http://marsdd.com OCAD University Research: http://www.ocadu.ca/research Toronto Rehabilitation Institute http://uhn.ca/TorontoRehab Dr. Javad Sattarian Orthopaedic Surgeon Babak Taati Ph.D., P.Eng, 3D Visualization, Toronto Rehab Heal.X - June 2013 8