Leg Up
Project undertaken in course year 2022-23 with the Stanford School of Medicine
Project Goal
To develop a lower-leg prosthesis socket that tightens and loosens automatically to match loads required by the current stage of the walking cycle. The focus of this class project is to develop a mechanism to apply pressures needed to hold the prosthesis in place while staying below pressures that cause pain.
Project Motivation
Among over 2.1 million individuals in the US who have undergone amputation, 80-90% are lower leg amputees. For many of them, prostheses are crucial in enabling them to carry out regular activities and perform their jobs. We aim to improve quality of life for lower-limb amputees by designing a socket that is simultaneously comfortable and safe.
Background
Current prostheses on the market often have issues with comfort and stability, which reduces the efficacy of the device. A prosthesis socket that is too loose causes instability; one that is too tight causes skin irritation and pressure sores. A socket that can adjust automatically would be the best of both worlds.
When walking, the need for the tightness of fit varies through the walking gait, with the tightest fit needed just before heel strike, and the loosest fit between heel off and toe off.
ME170 teams in previous years have developed a system that can determine the current phase of walking, which can be used in this project as input for when to tighten/loosen the prosthesis fit.
The distal tip of the limb should not take on the load of the body weight, so pressures holding the prosthesis need to be sufficent to keep distal tip loads constant.
High Priority Requirements
Pressure on the residual limb may never reach the user pain threshold while loaded with 2250 N axial load.
Pressure on the Distal Tip shall stay below 0.45 MPa
Ethical Considerations
Accessibility: Device should be accessible to people of any financial situation
Environmental Cost: Device should be durable and repairable to reduce waste
Limited User Input: The design team on this project are all able-bodied, device should be designed with direct input from amputees
Solution
A nylon socket with a tightening mechanism made of steel cable and four pulley hardpoints. Tightening mechanism is actuated by applying tension to the cable, which acts like a shoelace to tighten the socket.
System hardware
Image on the left shows the CAD model of the socket with pulleys and attachments. Image on the right shows the final 3D printed design of the nylon socket with pulleys and cable. As tension is applied to the wire rope, the sides of the socket will be pulled together to apply pressure to the socket inside.
Casting the limb model
To conduct testing, a model of the amputated limb is needed. The team developed a 3D mold, and filled with concrete to prepare a model for the limb, and covered it with a layer of silicone gel to simulate muscle/skin.
Inside of socket
Placement of pressure sensors inside the socket. The sensor in the center of the figure, at the bottom of the socket, measures pressure at the distal tip.
Test setup
System used to apply tension in wire rope, tightening the socket around the concrete limb. A load is applied to the top of the limb - shown with brick under an Instron tester - to determine how pressure on the distal tip of the is affected by increasing load and pressure
Compressive pressure at popliteal muscle location
As the wire rope is tightened, the gap in the socket opening decreases, which is a measure of tightening the socket.
At varying downward loads up to 1700N, the compressive pressure to keep the limb from slipping in the socket, is seen to level off at 0.35 MPa, which is below the max pain threshold of 0.44MPa.
Test results for pressure on Distal Tip
As higher downward force is applied to the socket (up to 1700 N), the load on the distal tip *decreases* or stays constant. All values are below the max pain threshold of 0.45MPa
Test Observations
Some of the silicone from the limb can be seen to leak out of the socket during testing. This may have skewed pressure reading results since some pressure was being relieved by the loss of silicone.
Other testing conducted
Compressive pressure at anterolateral tibia, medial tibial flare. All also stayed below 0.44 MPa pressure
Student team
Future Work
Test up to 2250N downward load
Determine ability to loosen fit
Achieve desired tightness and looseness within 0.05ms
Integrate motor into socket design to apply appropriate tension to wire rope
Integrate gait detection software to synchronize tightening and loosening when needed
Finalize materials for socket