Rotator Cuff Graft Deployment Device with Nitinol Expansion
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Solution Overview
Problem
Current graft deployment technologies for rotator cuff repair and reconstruction are complex and costly, requiring multiple steps and often necessitating suture preparation, which can complicate surgical procedures and increase the risk of errors.
Innovation Solution
A single-use graft deployment device featuring a handle, trigger, collapsing insertion mechanism with an outer sheath and expansion mechanism, allowing for simplified graft loading and deployment, which includes a nitinol wire for selective pressure application and visualization, reducing the need for sutures and simplifying the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If traditional graft deployment technologies are used, then graft deployment can be achieved, but the procedures become complex and costly requiring multiple steps and suture preparation
Solution Approach 1:
The patent combines multiple separate components (outer sheath, inner sheath, expansion mechanism, graft) into a single integrated deployment device. The graft is loaded onto the expansion mechanism which is nested within the sheaths, allowing all components to be deployed simultaneously in one procedure rather than requiring multiple separate steps and suture preparations.
Solution Approach 2:
The deployment device is segmented into distinct functional components: the outer sheath for protection and positioning, the inner sheath for graft containment, the expansion mechanism for graft deployment, and the graft itself. This segmentation allows each component to perform its specific function while working together as a unified system, simplifying the overall procedure.
2Ease of operation
If traditional deployment devices are used, then graft deployment is possible, but multiple steps and suture preparation are required increasing the risk of errors
Solution Approach 1:
The graft is pre-loaded onto the expansion mechanism during manufacturing, and the entire assembly is pre-packaged within the sheaths. This preliminary preparation eliminates the need for intraoperative graft preparation and suture handling, allowing the surgeon to simply activate the deployment sequence without time-consuming setup steps.
Solution Approach 2:
The expansion mechanism is designed to automatically expand and deploy the graft when activated by the delivery system, without requiring manual manipulation or additional suture work. The mechanism self-activates the graft deployment process, reducing the surgical steps required and minimizing the time needed for the procedure.
3Strength
If the expansion mechanism maintains rigidity after expansion, then compression against target tissues is enabled, but the mechanism becomes difficult to manipulate
Solution Approach 1:
The expansion mechanism transitions from a flexible, easily manipulated state during delivery to a rigid, compression-capable state after expansion. This dynamic transformation allows the mechanism to be easily positioned and deployed while maintaining the ability to apply strong compression against target tissues once expanded, resolving the contradiction between manipulation ease and compression strength.
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 device enables streamlined surgical procedures by minimizing the need for suture preparation, allowing for precise graft placement and fixation with reduced complexity and cost, while maintaining rigidity for effective compression against target tissues.
Implementation Method 1
the wire is made of or includes nitinol
Data Source
AI summary
Systems, devices, and methods for deploying a graft to a treatment site of a patient. Exemplary systems include a device body and an insertion mechanism. The device body can have a handle and a trigger, and a controller. The insertion mechanism can be in operative association with the device body, and can have an outer sheath, a central shaft disposed at least partially within the outer sheath, an expansion mechanism in operative association with the central shaft, and a graft that can be deployed by the expansion mechanism.