ASR
ASR
surgical device
The TITAN CSR™ is a lightweight titanium surgical retractor that combines the speed of self-retaining retractors and the exposure of traditional table-mounted systems, all without a table attachment.
Surgical retractors are medical instruments used during a surgical procedure to keep an incision in the body open while a surgical procedure is being performed. They provide better visibility for the surgeon so the procedure can be performed easily and quickly.
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development
ASR
development
ideation |
Link worked with the team at Advanced Surgical Retractors Inc to realize Dr Ramon Cestero’s vision: a lightweight, rapidly deployable, self-retaining abdominal surgical retractor that could provide the same tissue exposure as the cumbersome table-mounted state-of-the-art retractor systems. The Link team began to generate ideas through brainstorming, market research, product tear-downs, and concept sketching. Concept downselection was based on product cost, weight, manufacturing/assembly complexity, sterilizability, ease of use, and ergonomics.
From concept sketches, concept CAD models were created to facilitate rapid prototyping and initial FEA simulations. 3D printed prototypes were evaluated and iterated upon over a process of months, with surgeon feedback received at each step of the way.
| PROCESS
EXPANSION
The Titan CSR expands to provide exposure and visibility to the entire abdominal cavity. The ratcheting system can be easily expanded by one or two surgeons, without the need for button actuation.
EXPOSURE
Once expanded to the desired position, the ratchets hold the incision open to provide access to abdominal organs and tissues, withstanding forces over 140lbs. The perimeter ring is compatible with other existing surgical accessories, allowing for specific exposures as required by the surgeon during specialized procedures.
HEIGHT ADJUSTMENT
Titan blades can be adjusted along the perimeter of the ring to fit in incisions from 13cm to 37+cm in length. They can also be adjusted vertically to position the perimeter ring in the desired position above the patient.
Robust prototypes were needed to evaluate performance of design concepts. Initial inexpensive and easily machined aluminum and steel prototypes helped further refine the conceptual design, until a fully functional like-material unit was needed. Ti prototypes allowed for complete, reliable, and realistic evaluation of the design.
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PRODUCT VISUALS
The LINK design team was also responsible for creating renders, animations, and instructional graphics. These images are used in marketing materials and instructional documentation. The animations detail the mechanisms, adjustability, and overall use of the product.
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TESTING
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TESTING
TESTING |
At each prototyping phase, extensive testing was performed to ensure that the retractor met reliability, durability, fit and function requirements.
FEA simulations were conducted on individual components to ensure that the device would be able to withstand the high forces seen during surgical procedures.
Cleaning verification and validation was performed with an FDA regulatory partner to ensure that the design could be easily sterilized under existing hospital and field sterilization protocols.
Prototypes developed in house were used to conduct use and abuse testing, on both components and assemblies. Link PD developed a test fixture to simulate the resistance of human tissues in order to evaluate the ease of expansion and contraction, as well as the performance of all other subassemblies.
In-depth performance evaluation of prototypes was conducted in partnership with the Centre for Emergency Health Sciences, a medicine and health-sciences educational facility in Spring Branch, TX. The Titan CSR prototypes were tested in cadaver labs to provide simulation of performance and use in live patients. In these sessions, feedback was gathered from surgeons, surgical fellows, operating room technicians, and military field surgical technicians. After each cadaver lab, the design was iterated based on quantitative performance results as well as qualitative feedback.
| FIELD TESTING
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PRODUCTION
After prototyping, TITAN CSR design was transitioned into production manufacturing. With their expertise in precision machining and assembly, Reata Engineering (located in Englewood, CO) has been a perfect partner for Link PD and Advanced Surgical Retractor Systems. Link worked extensively on-site with Reata and their subcontractors to dial-in design for manufacturability (DFM) prior to ramping up to full-scale production. More information about ASR and the TITAN CSR can be found by following the link below.