Modular Surgical Clip Applier for Precise Vessel Ligation
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Solution Overview
Problem
Existing surgical clip appliers for laparoscopic and endoscopic procedures face challenges in precise and secure control, leading to potential damage to blood vessels or interference with the surgical site due to slippage or imprecise clip application.
Innovation Solution
A surgical clip applier with a reusable handle and disposable cartridge assembly, featuring a trigger mechanism that moves through multiple positions to control a drive mechanism, allowing precise application and ligation of surgical clips, including a cinch rod and clip pusher to open, load, and close the jaws accurately.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a surgical clip applier is designed with a single integrated component, then control precision and security are improved, but device complexity and cost increase
Solution Approach 1:
The surgical clip applier is divided into two separate components: a reusable handle assembly and a disposable cartridge assembly. This segmentation allows the complex drive mechanism to be contained within the disposable cartridge, while the reusable handle provides ergonomic control. The modular design maintains control precision through precise mechanical coupling between components while reducing overall system complexity and cost by allowing independent optimization of each component.
Solution Approach 2:
The cartridge assembly containing the drive mechanism, surgical clips, and delivery components is designed as a single-use disposable component that is discarded after one application. The expensive and complex drive mechanism, along with the surgical clips and sterile components, are contained in the disposable cartridge. The reusable handle assembly can be sterilized and used multiple times, reducing overall cost while maintaining control precision during the critical surgical application.
2Ease of manufacture
If a disposable cartridge assembly is used, then cross contamination is minimized and ease of manufacture is improved, but control precision may deteriorate
Solution Approach 1:
The disposable cartridge assembly is pre-loaded with a precise array of surgical clips in the correct orientation and spacing before sterilization. The drive mechanism is pre-calibrated during manufacturing to ensure precise actuation of the cinch rod and clip pusher. This preliminary preparation ensures that control precision is maintained while simplifying the manufacturing process, as the cartridge can be assembled and tested independently of the reusable handle assembly.
Solution Approach 2:
The cartridge assembly is designed as a low-cost disposable component that can be manufactured using inexpensive materials and processes. The disposable nature allows for simplified manufacturing without the need for high-precision machining or expensive materials, while the precise mechanical design ensures that control precision is maintained during use. The cartridge is discarded after one use, eliminating the need for complex sterilization and maintenance procedures.
3Measurement precision
If a trigger mechanism with multiple positions is implemented, then surgical precision is improved, but device complexity increases
Solution Approach 1:
The trigger mechanism is designed with multiple discrete positions (first, second, third, and fourth positions) that correspond to different stages of the surgical clip application process. As the trigger is squeezed, it progresses through these positions sequentially, activating different functions: opening the jaws, loading the clip, closing the jaws, and ligating the vessel. This dynamic progression through discrete positions provides surgical precision while keeping the mechanism relatively simple, as each position activates a specific function through the existing drive mechanism rather than requiring separate control systems for each action.
Data Source
AI summary
A surgical clip applier with a disposable surgical cartridge assembly and a non-disposable handle with a trigger for controlling the placement of surgical clips from the surgical cartridge assembly. The trigger moves an internal cinch to open surgical jaws to consecutively receive and hold surgical clips from a internal linear array of clips. Further movement of the trigger on handle moves the internal cinch to close the jaws and the surgical clip contained within over the ligation site.