Flexible Endoscopic Stapler with Clearance Cutouts
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Solution Overview
Problem
Current medical procedures for treating abdominal and gastrointestinal issues require invasive open or laparoscopic surgery due to the lack of a reliable method for stapling tissue using flexible endoscopes, leading to increased morbidity, mortality, and lengthy recovery times.
Innovation Solution
A medical device comprising an actuator handle, a flexible inner tubular member with pivotable jaws, and an outer tubular member with cutouts that allows for the deployment of a staple through a flexible endoscope, enabling secure tissue closure with minimal invasiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open or laparoscopic surgery is used to perform stapling procedures, then reliable tissue stapling can be achieved, but the surgery becomes more invasive with longer recovery times and higher morbidity
Solution Approach 1:
The stapling device is nested within the flexible endoscope, with the stapler mechanism contained inside the endoscope's working channel. The outer tubular member and inner tubular member are nested concentrically, allowing the entire stapling apparatus to be delivered through the minimally invasive endoscope while maintaining full stapling functionality.
Solution Approach 2:
The device transitions from a compact delivery configuration to an expanded working configuration. The outer tubular member and inner tubular member are flexible and can be deployed to provide structural support and mechanical advantage during stapling, then retracted for removal. The jaws pivot from an open to closed position dynamically during the stapling operation.
2Object-affected harmful factors
If a flexible endoscope is used to deliver the stapling device, then the procedure becomes less invasive, but the mechanical complexity of delivering and deploying the staple increases
Solution Approach 1:
The device is divided into distinct functional segments: the outer tubular member for delivery and structural support, the inner tubular member for jaw actuation, the pivotable jaws for tissue grasping, and the staple for tissue approximation. This segmentation allows each component to be optimized independently and simplifies the overall delivery mechanism.
Solution Approach 2:
The inner tubular member acts as an intermediary between the operator's manual actuation and the jaw closing mechanism. By pushing the inner tubular member distally, the operator indirectly actuates the jaw closure through the pivot mechanism, providing mechanical advantage and precise control without requiring complex direct actuation mechanisms.
3Manufacturing precision
If the jaws are made rigid to ensure precise staple placement, then stapling accuracy improves, but the device cannot navigate the flexible endoscope's working channel
Solution Approach 1:
The outer tubular member and inner tubular member are flexible during delivery to navigate the endoscope's working channel, then provide rigid structural support when deployed. The pivotable jaws transition from a compact flexible state during delivery to a rigid closed position during stapling, ensuring both deliverability and precision.
Solution Approach 2:
The tubular members are constructed with flexible materials that allow bending and navigation through curved anatomical pathways and the endoscope's working channel, while maintaining sufficient structural integrity to transmit actuation forces and support the rigid jaws during the stapling operation.
4Strength
If the staple is designed to penetrate deeply into tissue to ensure secure closure, then the strength of tissue approximation improves, but the risk of tissue damage and complications increases
Solution Approach 1:
The jaws are designed with differentiated local properties: the distal tips are sharp and rigid for precise penetration and secure tissue grasping, while the proximal portions are more flexible for safe navigation and actuation. The staple itself has localized sharp edges for tissue penetration and broader flanges for secure approximation, concentrating the invasive action only where needed.
Data Source
AI summary
A medical device includes an actuator handle, an elongate flexible inner tubular member operatively connected at one end to the handle, two jaws pivotably mounted to a distal end of the inner tubular member and biased to an open configuration, and an elongate flexible outer tubular member operatively connected at one end to the handle and slidably surrounding the inner tubular member. The outer tubular member is provided at a distal end with two cutouts or open slots opposed to one another to define a pair of longitudinally extending opposed fingers. The fingers are engageable with respective ones of the jaws to pivot the jaws towards one another during a distally directed stroke of the outer tubular member so that the jaws assume a closed configuration. The cutouts or open slots are disposed alongside the jaws in the closed configuration thereof to provide clearance for tissue material grasped in and protruding laterally from the jaws.