Preloaded Graft Deployment System with Expansion Mechanism
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Solution Overview
Problem
Current graft deployment technologies for rotator cuff repair and reconstruction are cumbersome, requiring manual preparation and suture, and lack efficient mechanisms for graft placement and fixation, leading to longer surgical times and increased costs.
Innovation Solution
A single-use graft deployment system with a handle, trigger, and insertion mechanism featuring a preloaded graft and expansion mechanism, such as a balloon or shape memory expansion mechanism, that simplifies the deployment process by allowing for controlled graft placement and fixation without the need for separate graft preparation or suturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual graft preparation and separate loading are used, then graft deployment can be performed, but surgical time and complexity increase
Solution Approach 1:
The patent combines the graft preparation, loading, and deployment functions into a single integrated device. The graft is pre-loaded onto the deployment device in a controlled manufacturing process, eliminating the need for separate manual preparation and loading steps during surgery. This merging of functions directly addresses the contradiction by improving surgical efficiency while reducing procedure time.
Solution Approach 2:
The graft is prepared and loaded onto the deployment device in advance during manufacturing, before the surgical procedure begins. This preliminary action transfers the complex preparation and loading tasks from the surgical setting to the manufacturing setting, thereby improving intraoperative productivity and reducing surgical time.
2Ease of operation
If multiple separate devices are used for graft deployment, then graft placement can be achieved, but device complexity increases
Solution Approach 1:
The patent integrates multiple previously separate devices and functions into a single unified deployment device. This includes combining the graft storage, loading mechanism, deployment structure, and fixation elements into one integrated system. This merging reduces device complexity and simplifies the surgical procedure by eliminating the need to manage multiple separate devices.
Solution Approach 2:
The deployment device is designed with multi-functional capabilities, serving as both the graft carrier, deployment mechanism, and fixation tool. This universal design allows a single device to perform multiple functions that previously required separate devices, thereby reducing overall system complexity while maintaining ease of operation.
3Manufacturing precision
If traditional deployment methods are used, then graft can be placed, but control over graft positioning is limited
Solution Approach 1:
The deployment device incorporates localized features such as positioning ribs, guide channels, and targeted expansion zones that provide precise control over graft placement at specific locations. These local structural qualities enable accurate positioning control without requiring complex overall device design, thereby improving manufacturing precision while maintaining ease of operation.
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 reduces surgical complexity, shortens procedure time, and enhances graft placement control, enabling efficient and cost-effective rotator cuff repairs and reconstructions by eliminating the need for manual graft preparation and minimizing suturing requirements.
Implementation Method 1
an expansion mechanism, such as a balloon or shape memory expansion mechanism
Implementation Method 2
an expansion mechanism, such as a balloon or shape memory expansion mechanism
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, a trigger, and a controller. The insertion mechanism can be in operative association with the device body, and can have an outer sheath, a support shaft disposed at least partially within the outer sheath, an expansion mechanism coupled with the support shaft, and a graft in contact with the expansion mechanism.