Calavera Surgical Design
Calavera Surgical Design (Calavera) is a startup out of Sunnybrook Health Sciences Centre in Toronto, Ontario with a team comprising leading professionals in surgery, imaging research, and design. Specializing in craniomaxillofacial (CMF) implants, Calavera has developed several innovations in pre-operative planning for facial reconstructions.
Calavera’s unique process integrates the most sophisticated computer modeling and rapid prototyping technology with specific expertise in CMF surgery, 3D imaging, and 3D design. A three-dimensional rendering of a patient’s anatomy is created using computerized tomography (CT) scans. Then, specialized software, an anatomical reference database, and expert knowledge are used to create a patient-specific surgical solution. Rapid prototyping technology is subsequently employed in manufacturing custom shaping tools, skull bio-models, and implants for a wide range of surgical tasks.
Calavera is using CIMTEC’s engineering expertise to develop a mechanical press that can apply the required force to mold various materials such as titanium mesh, porous polyethylene, poly methyl methacrylate (PMMA), and bone into custom implants while in the operating room. The company has also contracted CIMTEC to provide a regulatory assessment for entry into the US and European markets
Need or Opportunity:
Craniomaxillofacial injuries, traumas, and birth defects have immense physical and psychological impacts on the lives of sufferers. In North America, annually there are over 24,000 surgeries to correct these defects, including 3,500 in Canada alone. Complications of reconstructive surgery are related to pre-operative planning limitations, ensuring fidelity to recognizable anatomic features, and post-operative susceptibility to infection among other things.
Surgeons want access to a faster, simpler, and more accurate method of restoring normal anatomy. Currently, cranial and orbital reconstructions are performed with a variety of materials that are shaped prior to surgery based on CT scans and reference skulls. Pre-operatively prepared implants do not allow for surgeons to make important discretionary changes after assessing a patient’s specific anatomy in the operating room. The lack of customization using current methods can result in decreased post-operative health outcomes for patients.
Calavera’s process, procedures and technology have already been applied in over 50 skull and orbital reconstructions. Clinical application of Calavera’s technology improves surgical outcomes and quality of life for patients, and substantially diminishes operating time. With CIMTEC’s help, Calavera will soon be in a position to sell its device around the world to other hospitals with specialized operating rooms.
Understanding that floor space within operating rooms is very limited, Calavera’s goal is to provide surgeons with one compact, fully sterilizable delivery system that includes a suite of integrated technology for customized, on-demand shaping of implant materials for any patient’s need.
CIMTEC designed and built a press that can exert the required pressure to precisely mold a variety of materials in a wide span of sizes and anatomical locations, which will allow surgeons to customize the implant and optimize post-operative outcomes for patients.
In addition to the mechanical engineering of a press, CIMTEC also provided a regulatory assessment and assistance developing standard operating procedures (SOPs) and a quality assurance program for the new technology to prepare Calavera to enter a global market.
With eventual patents in Canada, the United States, Europe, and China, Calavera’s custom molding system has the potential to be used by plastic surgeons, maxillofacial surgeons, otolaryngologists, and neurosurgeons around the world within the next five years ensuring restoration of thousands of patients’ premorbid anatomy.