Osseointegrated Interface Device With Sealing Flange
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Solution Overview
Problem
Current prosthetic interface devices for amputees face issues such as weak coupling, discomfort, risk of infection, and the need for multiple surgeries due to inadequate mechanical robustness and long-term skin-implant viability.
Innovation Solution
An osseointegrated interface device with a cap portion and stem portion, featuring a surrounding flange that receives the skin at a distance from the osseointegrated device, and a stem portion that can be osseointegrated, along with a prosthesis connector and ports for biosensors, cables, and fluid access, utilizing biocompatible materials and designs to enhance integration and reduce surgical requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a cup/socket arrangement is used to connect prosthetics to amputated limbs, then aesthetic concerns are addressed, but the coupling interface is weak and functional strength is insufficient
Solution Approach 1:
The prosthetic system is divided into separate components: an osseointegrated implant anchored in the bone, a socket interface that connects to the prosthesis, and a sealing element. This segmentation allows the coupling strength to be dramatically improved through direct bone anchorage while keeping the external interface simple and manageable.
Solution Approach 2:
An osseointegrated implant serves as an intermediary element between the patient's bone and the prosthetic device. This intermediary provides a strong, stable anchor point within the bone, eliminating the need for weak soft-tissue attachments while maintaining a simple external interface.
2Strength
If percutaneous osseointegrated interface devices are used to improve functionality, then functional strength is improved, but the risk of infection at the transcutaneous site increases
Solution Approach 1:
The harmful transcutaneous penetration is extracted and replaced with a subcutaneous osseointegrated implant. The implant is anchored entirely within the bone below the skin surface, eliminating the open wound channel that allows bacterial entry while maintaining strong functional coupling.
Solution Approach 2:
The sealing element (O-ring) is designed as a simple, replaceable component that provides infection protection. This disposable-like element can be easily replaced if degraded, providing continuous protection without compromising the permanent osseointegrated implant.
3Object-affected harmful factors
If a seal is formed between the skin and the implant to reduce infection risk, then infection risk is reduced, but long-term skin-implant viability and mechanical robustness are not demonstrated
Solution Approach 1:
The sealing function is assigned to a simple, replaceable O-ring element rather than relying on the permanence of the implant-se skin interface. This allows the seal to be easily replaced if it degrades, ensuring continuous protection without compromising the long-term viability of the osseointegrated implant.
Solution Approach 2:
The sealing mechanism transitions from relying on tissue ingrowth and biological integration to using a mechanical elastomeric seal. This parameter change from biological to mechanical sealing provides immediate, reliable infection protection while the osseointegrated implant maintains long-term structural integrity.
4Reliability
If multiple surgeries are performed to fit threaded bars and corrective procedures, then proper osseointegration is achieved, but the treatment time and patient burden increase significantly
Solution Approach 1:
The osseointegrated implant is designed to be installed in a single surgical procedure with preliminary preparation of the bone site. The implant includes pre-formed threading and integration features that eliminate the need for subsequent corrective surgeries, reducing total treatment time while ensuring reliable osseointegration.
Solution Approach 2:
The osseointegrated implant serves multiple functions simultaneously: it provides structural anchorage, enables prosthetic attachment, and creates a sealed interface. This multi-functionality consolidates what would otherwise require multiple separate surgical procedures into a single intervention, reducing patient burden and treatment time.
Data Source
AI summary
Herein described is an osseointegrated interface device for engagement with an amputated limb including the skin comprising: a cap portion engageable with an osseointegrated device; wherein the cap portion comprises a surrounding flange; and wherein in use the surrounding flange receives the skin of the amputated limb at a distance spaced from the osseointegrated device.