Bone Staple Insertion Tool Fulcrum Expansion Mechanism
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Solution Overview
Problem
Traditional bone staples are often supplied in a pre-sterilized, expanded format, which can lead to damage during shipping and storage, reducing their ability to return to a compressed state for optimal compression force application, and existing insertion tools can apply unwanted forces on the staples and patient's bones during implantation and removal.
Innovation Solution
A bone staple insertion tool with a body, bone staple mount, and force applicator that allows the staple to be expanded just before implantation, featuring a gripping portion and staple pin portion that bend the staple across a fulcrum, enabling the staple to be inserted in a sterilized, unexpanded state and expanded only briefly for optimal compression.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If bone staples are supplied in a pre-sterilized, expanded format, then they are ready for immediate use, but the staple may be damaged or its elasticity may be reduced during shipping and storage
Solution Approach 1:
The staple is pre-sterilized and pre-mounted to the insertion tool, but the expansion action is performed immediately before implantation by the surgeon actuating the force applicator. This preliminary preparation maintains sterility and readiness while avoiding premature expansion that would cause damage during shipping and storage.
Solution Approach 2:
The insertion tool incorporates a force applicator with a gripping portion that can dynamically expand the staple from a compressed delivery state to an expanded implantation state. This dynamic mechanism allows the staple to transition from a compact, protected state during shipping to an expanded, functional state immediately before use, resolving the contradiction between readiness and reliability.
2Reliability
If rigid insertion devices are used to deliver pre-sterilized staples, then sterility is maintained, but additional forces are applied to the staple and patient's bone during removal
Solution Approach 1:
The insertion tool uses a force applicator with a gripping portion that can be actuated to expand the staple and then de-actuated to release it. This dynamic design allows the staple to be held securely during insertion while enabling easy release after implantation, avoiding the unwanted forces associated with rigid fixed devices during removal.
Solution Approach 2:
The force applicator acts as an intermediary mechanism between the surgeon's manual actuation and the staple. It provides controlled force application for expansion and controlled release for removal, mediating the interaction to minimize harmful forces on both the staple and patient's bone during the removal process.
3Productivity
If staples are expanded during shipping and storage, then they are ready for implantation, but compression forces are reduced due to damage and loss of elasticity
Solution Approach 1:
The sterilization and mounting actions are performed in advance, but the expansion action that generates compression force is performed immediately before implantation. This timing ensures the staple maintains full elasticity and compression capability while being ready for use, as the expansion occurs just moments before the staple is needed rather than days or weeks earlier during shipping and storage.
4Reliability
If multiple sterilization steps are required for non-sterilized staples and insertion tools, then sterility is achieved, but surgical time and complexity increase
Solution Approach 1:
The staple is pre-mounted to the insertion tool in a factory setting and both are sterilized together as a single assembled unit. This merging of components before sterilization eliminates the need for separate sterilization steps for the staple and tool, reducing surgical preparation time while maintaining sterility. The combined sterilization process is more efficient than multiple separate steps.
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 tool ensures the staple is delivered in a sterilized, unexpanded state, minimizing damage and allowing for precise expansion just before use, reducing the risk of unwanted forces on the patient's bones during implantation and removal, while maintaining the staple's compression capabilities.
Implementation Method 1
Many bone staples are made of Nitinol and take advantage of the superelastic property of this material. The implant is formed with the legs in a compressed or inwardly biased state, which is expanded prior to implantation so that there is material bias to return to the compressed state to impart compression at the bone interface when implanted.
Data Source
AI summary
A bone staple insertion tool for inserting a bone staple into a patient includes a body having a proximal portion, a distal surface and a fulcrum. The body defines a longitudinal axis and the fulcrum is positioned on the distal surface. The distal surface has a first end and a second end. A bone staple mount is fixed to the body and extends from the body proximate the first end. A force applicator is movably attached to the body. The force applicator has a gripping portion and a staple pin portion. The staple pin portion is positioned proximate the second end. The force applicator is configured to receive the bone staple. Upon actuation of the gripping portion, the staple pin portion bends the inter-axis of the bone staple across the fulcrum to an expanded state, wherein the first and second legs are positioned substantially parallel to the longitudinal axis.