Stapling Device with Recessed Introducer for Tissue Perforation Closure
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Solution Overview
Problem
Existing visceral staples face challenges in ensuring proper tension and closure of tissue perforations, especially in delicate areas like the gastrointestinal tract, and are often cumbersome for endoscopic and laparoscopic procedures.
Innovation Solution
A stapling device with an introducer member and a holding mechanism that allows for controlled deployment of staples, enabling precise alignment and tensioning of staples to close tissue perforations effectively, featuring a recessed design and various holding mechanisms for versatile use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a series of staples are placed around a perforation using existing devices, then the perforation can be closed, but it becomes difficult to properly tension each individual suture to ensure proper approximation of tissue and complete closure
Solution Approach 1:
The device divides the stapling function into modular components: individual staples are separately loaded into the introducer member, allowing each staple to be independently positioned and tensioned. The holding mechanism with movable holding surface enables separate control of each staple's deployment, facilitating proper tissue approximation for each staple location around the perforation.
Solution Approach 2:
The introducer member acts as an intermediary device that holds multiple staples in a controlled manner before deployment. The holding mechanism with movable holding surface serves as a mediator between the staples and the tissue, allowing precise control over when and how each staple is released and tensioned during the closing process.
2Reliability
If bulky staple delivery devices are used to ensure reliable staple placement, then closure reliability improves, but the devices become difficult to use in endoscopic and laparoscopic procedures
Solution Approach 1:
The device employs a nested structure where multiple staples are individually housed within recesses of the introducer member, which itself is contained within the delivery device. This nesting allows multiple functional elements to be compactly arranged, reducing the overall device bulk while maintaining the capability for reliable, controlled staple placement in confined endoscopic and laparoscopic environments.
Solution Approach 2:
The introducer member features recesses that extend in a direction transverse to the longitudinal axis, creating a three-dimensional arrangement of staples within the delivery device. This spatial organization allows multiple staples to be compactly stored and sequentially deployed, reducing device bulk while maintaining placement reliability in minimally invasive procedures.
3Device complexity
If a simple holding mechanism is used to release the staple, then device complexity is reduced, but control over staple deployment may be insufficient
Solution Approach 1:
The holding mechanism employs a movable holding surface that can dynamically transition between engaged and disengaged positions. This dynamic capability allows the simple-looking mechanism to provide precise control over staple deployment: the holding surface moves to engage and retain the staple during delivery, then moves away to release the staple for controlled deployment, achieving both simplicity and control.
Data Source
AI summary
Medical devices and related methods for closing a perforation in a bodily wall are provided. The medical device generally includes an introducer device having a base defining a plurality of recesses formed therein. Visceral staples are disposed within the recesses in a delivery state and are biased toward a deployed state. A holding mechanism retains the staples in the delivery state, and the holding mechanism is moveable relative to the base to allow the staples to extend out of the recesses. The biased nature of the staples will cause them to transition into the deployed state after the staples have been released, such that the staples will thereby pierce adjacent tissue and remain closed. The holding mechanism can be retractable or pivotable out of engagement with the staples. The introducer device can include upper and lower jaws or a slidable cover relative to the base.