The original concept designed in Solidworks featured four sets of telescoping poles surrounding the healing leg and supporting a seat to transfer loads to the ischium of the pelvis. Body attachments and adjustable loading features were yet to be fully determined, but cuffs were designed to attach future straps to the upper poles, and hinges were incorporated to allow a more natural gait pattern. Nearly every feature on this version of the device would see drastic changes by the end of the year!
Fully assembled in early December 2021, the first physical prototype of the device featured aluminum and plastic components, all machined or 3D printed by the team members. This first prototype was intended to verify several aspects of the design before moving forward with the development of an adjustable loading system. Thus, this iteration did not incorporate the capacity for adjustable loading and instead served as proof of concept for the other features of the device and the system as a whole. The obvious weak link in the system was the prototyped plastic hinge, which failed (as anticipated) during initial testing. Team members noted little to no loading occurring in the front poles, and planned a redesign eliminating much of the anterior portion of the device to slim down the product. The adjustable height telescoping poles proved to work as intended, but would require shortening. The seat was unable to be fully tested due to poor alignment once the device was secured to the body, a problem that would be remedied in subsequent iterations. The first prototype also indicated that the team would need to create a custom harness attachment system, as the elasticity of the off-the-shelf version used here added slack to the system and made walking difficult as the device lagged behind the user's movement (see video below).
Sam takes the team's first step using the initial prototype device
Based on lessons learned from the initial prototype, the device was slimmed down to only two supports on the posterior (back) side of the device. Not only was very little force being transferred to the front poles, but the removal of the poles also allowed for easier donning and better compatibility with the IROM leg brace typically worn post-surgery. A new "horseshoe" style foot plate was designed to allow the user's foot to contact the floor and minimize the height differential between the two legs. This iteration as shown here was short-lived, as parts were quickly updated, iterated, and traded out from week to week.
With the seat mostly untestable up until this point due to excessively posterior placement, the next iteration featured a new 3D printed seat mounted further forward on the device. This finally allowed us to effectively 'sit' on the device while wearing it. The upward pointing harness brackets were traded out for slots milled directly into the semicircular frame to decrease risk of injury from the protruding metal. The angled cross brace reinforcing the footplate and the telescoping poles was never fabricated using pipe stock as originally designed (seen in the photo render above) and was instead created with a cheaper and more easily manufacturable flat bar stock.
After much trial and error, testing, and receiving feedback from clinical experts, we arrived at our final design. Hinges were removed for stability and ease of control, and the seat was extended and made more concave to better support the user without sliding off. The semicircular seat mount was altered to feature belt loops for a new belt-like attachment harness. The telescoping poles were given a second line of holes offset from the first, to allow for higher resolution height adjustment. This feature also doubles as the loading adjustment, since the amount of load transferred to the femur increases as the patient's leg is lowered and the foot is allowed to make more contact with the ground. Schematics for all parts as shown here were sent off to be professionally machined, while the horseshoe-shaped footplate would remain 3D printed in-house and the seat would be cast from expanding polyurethane foam in a 3D printed mold.
Our nearly final iteration of the device was constructed using professionally machined aluminum parts in combination with our in-house 3D printed foot plate and custom cast foam seat. All verification and validation testing was conducted using this prototype, details of which can be viewed on the testing information page. For the safety of the team members, our first trials utilized a cane in conjunction with the device. The device in the photo was assembled from a combination of new and old parts for customer validation, because the upper semicircular frame was unavailable due to machinist error. For physical testing, the updated frame was added and the upper hook and loop strap shown in the photo was exchanged for an easy release canvas belt.
Fully assembled, this prototype weighed less than 5 pounds!
The final device was nearly identical to the prototype used for verification testing, with two small adjustments for comfort and stability. The seat was recast out of a new stiffer foam, because the previous version was noted to compress so much that the metal bracket inside become significantly noticeable and uncomfortable. An additional rubber-like TPU segment was designed and added to the bottom "heel" of the foot plate in order to cushion the heel strike, add stability during standing, and increase the traction of the plate against the ground.