Superelastic Orthopedic Implants for Low-Profile Bone Fixation
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Solution Overview
Problem
Existing bone implants for osteotomy procedures are difficult to install and can cause patient discomfort due to their prominence and soft tissue irritation, particularly in foot surgeries, necessitating a more comfortable and easier-to-install solution.
Innovation Solution
A bone implant with a spacer portion and an integral staple portion made of a superelastic material, such as Nitinol, that applies a compressive biasing force when installed under tension, providing ancillary support and preventing dislodgment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If plates with threaded openings and bone screws are used to secure spacers, then fixation reliability is improved, but device complexity and ease of operation deteriorate due to difficult installation and multiple components
Solution Approach 1:
The patent combines the spacer and fixation staple into a single integrated implant component. The spacer body includes directly formed staple structures with legs that penetrate bone surfaces, eliminating the need for separate plates and screws. This merging maintains fixation reliability while significantly reducing device complexity and simplifying the overall implant structure.
Solution Approach 2:
The integrated implant serves multiple functions simultaneously: the spacer body provides bone gap maintenance and structural support, while the incorporated staples provide fixation by penetrating and anchoring into the bone. This multi-functionality eliminates the need for separate fixation devices, reducing the number of components while maintaining both spacing and fixation capabilities.
2Reliability
If plates are used to secure spacers, then fixation stability is improved, but patient comfort deteriorates due to soft tissue and nerve irritation from prominent plates
Solution Approach 1:
The patent extracts the harmful prominent plate structure from the implant design and replaces it with low-profile staple structures that penetrate only the necessary bone depth. The staples have legs that engage the bone surface without requiring a large external plate, thereby maintaining fixation stability while eliminating soft tissue and nerve irritation caused by prominent plates.
Solution Approach 2:
The implant uses localized staple structures at specific attachment points rather than a continuous prominent plate across the entire bone surface. The staples provide fixation only where needed at the bone interface, while the majority of the implant profile remains low and conforming to the bone, minimizing soft tissue irritation in areas where fixation is not required.
3Object-affected harmful factors
If spacers are installed without ancillary fixation, then patient comfort is improved by eliminating plate irritation, but reliability deteriorates due to potential spacer dislodgment
Solution Approach 1:
The patent merges the spacer function with fixation function in a single integrated structure. The spacer body directly incorporates staple elements that penetrate the bone, providing retention without requiring separate ancillary fixation devices. This eliminates the need for prominent external plates while maintaining reliable spacer retention through the integrated staple anchoring mechanism.
4Reliability
If multiple separate components (plate, screws, spacer) are used, then fixation reliability is improved, but ease of operation deteriorates due to difficult installation procedures
Solution Approach 1:
The patent merges multiple separate components (spacer, staples, and fixation elements) into a single monolithic or pre-assembled integrated implant. This eliminates the need for multiple separate implantation steps involving separate plates and screws, significantly simplifying the surgical procedure while maintaining all necessary fixation and spacing functions in one device.
Solution Approach 2:
The integrated implant provides multiple functions (spacing, support, and fixation) in a single component that can be implanted in one procedure. The device simultaneously maintains bone gap spacing and provides secure fixation through incorporated staples, eliminating the need for sequential implantation of multiple separate components and reducing surgical complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The implant offers improved comfort and stability by minimizing soft tissue irritation and ensuring secure fixation without the need for additional fixation devices, enhancing patient recovery.
Implementation Method 1
at least the staple portion comprised of a material that has superelastic properties when at the temperature of the human body
Data Source
AI summary
Disclosed in an orthopedic implant that comprises a spacer portion having a superior portion and an inferior portion, and a staple portion. The staple portion is integral with the spacer portion and comprises a crown portion and first and second leg portions, the first and second leg portions having distal end that converge from the crown portion and that are composed of a material that has superelastic properties at body temperatures, whereby the first and second leg portions are configured to impart a compressive biasing force when the implant is installed with the legs under tension.