Self-aligning Shape Memory Alloy Spinal Staple
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Solution Overview
Problem
Existing surgical staple systems for orthopedic procedures, particularly in spinal fusion, are cumbersome and prone to dislodgment due to external alignment apparatuses, which can cause patient discomfort and inefficiency in spatially constrained environments.
Innovation Solution
A compression and fixation system comprising staples with a semi-rigid base member and deformable legs that can transition between unconstrained and constrained states, allowing for efficient stacking and application of compressive forces between bone segments, along with specialized insertion tools for precise placement and stabilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If external alignment apparatuses are used to maintain inserted position and arrangement of compressive implants, then implant positioning accuracy is improved, but device complexity and patient discomfort increase
Solution Approach 1:
The patent removes the external alignment apparatus from the system entirely. Instead, the staple itself incorporates alignment features (aligned legs and insertion path) that enable self-alignment during insertion, eliminating the need for separate external alignment devices and reducing overall system complexity while maintaining positioning accuracy
Solution Approach 2:
The staple is designed to be self-aligning through its structural features (parallel legs, defined insertion path) that guide its own placement into the bone. The insertion tool simply provides the forcing action while the staple's geometry ensures proper orientation and positioning without requiring external alignment apparatuses
2Stability of the object's composition
If external alignment apparatuses are used to maintain inserted position of compressive implants, then implant stability is improved, but patient discomfort and risk of dislodgment increase
Solution Approach 1:
The external alignment apparatus is removed from the system. The staple achieves stability through its own structural features (legs that engage bone, compression force application) without requiring external support structures, thereby eliminating the discomfort and dislodgment risks associated with bulky external devices
Solution Approach 2:
The staple self-stabilizes through its design: the legs are configured to engage the bone surfaces, the compression force is applied directly at the target site, and the structure maintains its position without external apparatuses, reducing patient discomfort and eliminating dislodgment risks from external device failure
3Force
If multiple staples are inserted into spatially constrained spinal column, then compression effectiveness is improved, but spatial efficiency decreases
Solution Approach 1:
The patent describes that staples can be nested within one another when not in use, with smaller staples fitting inside larger ones. This nesting capability allows multiple staples to be stored in a compact manner, improving spatial efficiency during storage and transport while maintaining the ability to deploy multiple staples for effective compression when needed
Solution Approach 2:
The staple incorporates a shape memory alloy that allows it to dynamically change its configuration. The staple can be inserted in a compressed state and then expand to its functional shape after insertion, enabling compact storage of multiple staples while maintaining their full compression capability when deployed in the spinal column
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 system provides improved spatial efficiency, reduced patient discomfort, and enhanced stability of implants by allowing for precise alignment and application of compressive forces, promoting bone fusion and healing while minimizing the risk of implant dislodgment.
Implementation Method 1
the staple includes a shape memory alloy and the staple transitions from a constrained state to an unconstrained state by heating the shape memory alloy above a transformation temperature of the shape memory alloy
Implementation Method 2
the staple transitions from a constrained state to an unconstrained state by heating the shape memory alloy above a transformation temperature of the shape memory alloy
Implementation Method 3
the insertion tool includes a heating element and the heating element heats the shape memory alloy to transform the staple from the constrained state to the unconstrained state
Data Source
AI summary
A staple apparatus can include a base member substantially coplanar to a first axis and a second axis perpendicular to the first axis. The base member can include a trapezoidal shape including two substantially equal length sides and two unequal length sides, the two unequal length sides comprising a first side and a second side with the first side being shorter than the second side and the first side being parallel with the second side on the first axis. The base member can include an aperture passing through a center point of the base member, a first indentation in the first side, and a second indentation in the second side. The staple apparatus can include a first pair of legs protruding from the first side of the base member and a second pair of legs protruding from the second side of the base member.