Each preform is injection molded with a distal base that is connected to the modular suspension system and alignment base. Xtremity offers seven sizes in standard and conical profiles. (Image: xtremity.com)

With the goal of tackling the need for prosthetic devices and their associated care, Denver-based medical device company Xtremity has developed thermoformable socket technology and cost-efficient fabrication processes that aim to have an impact on individuals with transtibial limb loss/difference, as well as the prosthetists who help them.

While prosthetic technology has seen incredible advancements over the past three decades, the socket, one of the device’s most important parts, has remained relatively unchanged, Xtremity’s Clinical Director Tres Wright told Tech Briefs. The socket — the part of the prosthesis that surrounds and supports the patient’s residual limb — is responsible for maintaining the comfort and function of the artificial appendage.

“Because it is such an integral part of a prosthesis, it’s also generally the source of any discomfort or inconvenience that amputees have with their prostheses,” he added. “Our team set out to alleviate this pain by establishing an innovative approach to an antiquated process. Our socket technology dramatically shortens the delivery time for the prosthesis and allows for rapid adjustments as the limb changes.”

(Image: xtremity.com)

Wright also told Tech Briefs that Xtremity, founded in 2017, developed the new transtibial-prosthetic-device-building method by using thermoformable socket preforms, which was made possible by using a proprietary, carbon-infused polymer designed specifically for such a unique application.

The thermoformable functionality of the XtremityTT socket, he said, allows a prosthesis to be built in mere hours, as opposed to weeks. “It also allows for the same socket to be reshaped or modified, rather than having to construct a new one from scratch, providing easy adjustments and fewer time-consuming prosthetists appointments.”

The traditional process requires highly skilled professionals to handcraft prosthetic sockets using toxic chemicals and large lab spaces with specialized equipment. Also, it requires multiple steps and, typically, each clinic or prosthetist has a slightly different method. Normally, to deliver a prosthesis it takes 4-7 appointments and at least 20-30 hours of labor over the course of several weeks. With this new method, a prosthesis can be completed in just hours.

But the XtremityTT socket wasn’t an overnight sensation. The team spent over six years in the research and development phase before commercially releasing the product.

“During that time, we faced many challenges,” Wright said. “The most difficult aspect was ensuring that the XtremityTT socket was tested thoroughly to a standard that would survive scrutiny from the academic community. Prosthetic sockets have always been handmade by individual prosthetists, meaning that there has never been an international testing standard.

“So, in essence, our product is so innovative that testing guidelines and regulations have not yet caught up. For that reason, we not only had to test our product, but also design a test while proving the methods were both accurate and rigorous. Our team spent several years on these efforts,” he added.

The XtremityTT socket is currently used by civilians and prosthetists throughout the country. However, due to its ability to get soldiers quickly equipped, it has also found a use by charities like The Protez Foundation, whose mission is to “provide state-of-the-art prosthetics with personalized training and support in the U.S. and follow-up care in Ukraine.”

“While the Xtremity socket system is meant for all people with transtibial limb loss, our core mission is to develop an innovative prosthetic device that could easily be fabricated in remote, war-torn, or underserved locations with minimal equipment or expertise, so it’s very rewarding to see that come to life in our ongoing work with Protez.”

Andrew Corselli is Digital Content Editor at SAE Media Group. For more information, visit here .