Our skin plays a huge role in our lives, it protects us from invading microorganisms and foreign substances, eliminates harmful toxins, helps to regulate our core body temperature, and is in charge of receiving both tactile and thermal stimulation. This amazing “shield” has a weakness though, it’s fragile and open wounds can get infected. But a paper by a group of Costa Rican researcher, Michelle Orozco-Brenes, José A. Jiménez-Chavarría, and Dagoberto Arias-Aguilar, titled “Design of a medical device for superficial suturing upper and lower extremities,” talks about their suturing device.
“This work presents the design for a class 2 medical device that meets the basic requirements of the current and known suturing methods in Costa Rica,” the abstract states. “The design process was achieved in three main stages, (i)Research on similar technologies, e.g. The operation principles of a sewing machine, materials used; (ii) The study of types of skin traumas; (iii) General approach toward the suturing device, including device functionality, integration with the human body and manufacturing process. The device model was designed and fabricated using 3D printing technology, this allowed the team to analyze ergonomics, the assembly of the parts and the equipment’s motion. The printed prototype made it possible for potential users to provide feedback on the design and suggestions for improvement.”
To save you a trip to google or a dictionary, suturing means to connect blood vessels with a specific material, such as thread, when tissue is torn in a way that halts natural healing. There are many suturing devices, but Costa Rican hospitals don’t use them because of expensive or complexity.
“The idea for a medical device to suture arose for three main reasons,” the researchers wrote. “First, physicians were noticing poorly sutured wounds that would result in large scars. These in some cases required further procedures like plastic surgery. Also, time consumption, making the search for a device that would make the method faster a necessity. Finally, sutures stitched by hand are sometimes left too loose or too tight, causing bleeding from the wound.”
The Class 2 FDA specifications for this device were functionality, cost, durability, modularity, and reliability. The team had additional specifications of stabilize the skin, rotate the needle on its axis to join tissue sections, and initiate and finish with the least amount of user interference.
“The final design was oriented to have the area and volume of the shell as similar as possible for the needle to rotate 360° without any problem,” the researchers explained.
The team made a prototype out of AISI 316L for its durability and low friction coefficient.
“After the prototype was assembled and design functions checked, the final step required a survey,” the team wrote. “The study contained questions about the medical device presented via prototype and they were asked to elaborate on their answers regarding their opinion as health professionals.”
A group of doctors, Dr. Stephanie Gómez Najéra, Dr. Pamela Villareal Valverde, and Dr. Tatiana Piedra Chacón, were given the device and asked to fill out a survey with the Likert scale, goes from 1-5, with 1 being strongly disagree and 5 being strongly agree.
“The comments reference that the usefulness depends on the context of where it would be applied, for example a jail or emergency room,” the researchers wrote of the doctors’ opinions on their device.
“One main drawback is that the device may not be suitable for all types of wounds. Other concerns raised by the physicians were related to the price and size of the device.”
With the results from the survey the team added a holder to the top for stability.
Saunders, Sarah. “Costa Rica: Researchers Design 3D Printed Medical Device for Suturing Extremities – 3DPrint.Com: The Voice of 3D Printing / Additive Manufacturing.” 3DPrint.Com | The Voice of 3D Printing / Additive Manufacturing, 7 Feb. 2020, 3dprint.com/262773/costa-rica-researchers-design-3d-printed-suturing-device/.