BabyHipCare, innovative orthosis for treatment of developmental hip dysplasia

• Grant number: 20/00977-8
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: August 01, 2022
• End date: November 30, 2024
• Field of knowledge: Engineering - Biomedical Engineering - Medical Engineering
• Principal Investigator: Natália Aurora dos Santos
• Grantee: Natália Aurora dos Santos
• Company: 3DTime Soluções Tridimensionais Ltda. - ME
• CNAE: Atividades de atenção ambulatorial executadas por médicos e odontólogos ; Atividades de serviços de complementação diagnóstica e terapêutica ; Atividades de atenção à saúde humana não especificadas anteriormente
• City: São Paulo
• Pesquisadores principais: Ellen de Oliveira Goiano ; Maria Elizete Kunkel
• Associated scholarship(s): 24/03226-4 - BabyHipCare, innovative orthosis for the treatment of developmental dysplasia of the child's hip, BP.TT; 23/01663-5 - BabyHipCare, innovative orthosis for the treatment of childhood developmental dysplasia, BP.TT; 22/10915-5 - BabyHipCare, innovative orthosis for treating developmental dysplasia of the infant's hip: 3D modeling and structural analysis of the orthosis., BP.TT; 22/11187-3 - BabyHipCare, innovative orthosis for the treatment of developmental dysplasia of the infant hip, BP.TT; 22/11098-0 - BabyHipCare, innovative orthosis for the treatment of infantile developmental dysplasia of the hip, BP.PIPE

Abstract

Development hip dysplasia (DDH) is a common orthopedic condition that if left untreated can cause sequelae in adulthood. The DDH occurs in 5 for every 1,000 births compromising the femoral head fitting in the acetabulum. In babies over six months old, DDH treatment consists of immobilizing the hip joint and legs with pelvipodalic cast for up to 120 days. Prolonged use of plaster does not allow adequate ventilation of the skin, and hygiene limitations promote several complications that are difficult to overcome in daily life. Despite the emergence of several innovative products in medicine, few innovations have been developed in this subject. This research began in 2017 at the Institute of Science and Technology of the Federal University of São Paulo to meet a demand from pediatric orthopedics at Dr. José de Carvalho Florence Municipal Hospital (São José dos Campos, SP), which has DDH as the most frequent cause of hip immobilization with plaster. Phase 1 of the research was carried out with the support of 3DTime and resulted in a prototype of children's hip orthosis, produced by 3D printing with polymeric material deposition process. A virtual baby corresponding to the age of 4 months was modeled and manufactured in the Salter position that is required for hip immobilization in the treatment of DDH. From this model, several hip closure prototypes were developed, manufactured and evaluated. After performing clinical trials of fitting and changing diapers with volunteer babies using the orthosis, the design of an innovative, lightweight, resistant, hygienic and ergonomic model was defined. Phase 1 confirmed the feasibility of producing a hip abductor orthosis that will be further evaluated in plaster replacement in the treatment of infant DDH and resulted in the creation of Startup BabyHipCare as a branch of 3DTime. In Phase 2 of the research will be investigated several scientific and technical challenges that need to be solved to obtain the final product. Mechanical tests, computational simulation and structural optimization will be used to evaluate the mechanical strength of the orthosis by redefining the model. An injection mold manufacturing process will ensure a product with better quality and cost to the consumer. A special BabyHip Care Diaper will be developed and evaluated in clinical trials in infants during the treatment of DDH. A smart version of the orthosis will be investigated using sensors to assess baby's biological signals and movement. It is hoped to develop a product that can solve a relevant problem of child orthopedics by improving the quality of life of the baby and his caregiver in the treatment of DDH. The BabyHipCare orthosis will be an innovative product that will serve the Brazilian market with the possibility of expanding to the international market as DDH is a problem that affects babies worldwide. (AU)