Endcap with Nested Needles for Perforation Closure
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Solution Overview
Problem
Existing tissue anchor deployment methods face challenges in evenly tensioning individual sutures around a perforation, particularly in the gastrointestinal tract, where improper closure can lead to infection due to bacterial contamination.
Innovation Solution
A medical device comprising an endcap with circumferentially spaced needles, a stylet cap, and stylets, which allows for the controlled deployment of tissue devices through an endoscope, enabling precise piercing and ejection of tissue anchors with adjustable suture tensioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If individual sutures are manually tensioned to close perforations, then tissue approximation can be achieved, but it becomes difficult to properly tension each suture evenly and completely close the perforation
Solution Approach 1:
The patent combines multiple suture tensioning functions into a single integrated device that deploys multiple tissue anchors simultaneously. The device integrates needle insertion, tissue anchor deployment, and suture tensioning into one unified system, allowing all sutures to be tensioned together through a single operational mechanism rather than requiring separate manual manipulation of each suture.
Solution Approach 2:
The device segments the tissue closure function into multiple independently deployable tissue anchors arranged circumferentially around the perforation. Each anchor can be independently positioned and deployed through its own needle lumen, allowing precise local control while maintaining overall system integration for simultaneous tensioning.
2Reliability
If multiple tissue anchors are deployed around a perforation, then complete closure can be achieved, but the complexity of collecting and connecting all individual sutures increases
Solution Approach 1:
The device merges the function of multiple suture management operations into a single integrated structure. All tissue anchors are pre-connected to the device framework, and their sutures are routed through integrated channels that converge at the proximal end, eliminating the need for separate collection and connection steps for each suture.
Solution Approach 2:
The sutures and tissue anchors are pre-positioned and pre-connected to the device structure before deployment. The sutures are pre-routed through the device's internal channels and pre-tensioned in a relaxed state, so that when the device is deployed, the tissue anchors are immediately ready for simultaneous tensioning without requiring post-deployment assembly or connection steps.
3Measurement precision
If needles are used to deploy tissue anchors through an endoscope, then precise piercing capability is achieved, but the risk of accidental needle exposure and injury increases
Solution Approach 1:
The device employs a nested protective structure where retractable protective tips are inserted within the needle lumens. These protective tips can be extended to cover the sharp distal ends of the needles when not in use, and retracted when tissue piercing is required. The protective tips are themselves nested within the main device body, creating multiple layers of protection and integration.
Solution Approach 2:
The protective tips are designed to be dynamically adjustable, transitioning between extended (protected) and retracted (exposed) states. This dynamic protection mechanism allows the device to adapt its safety profile based on operational requirements - providing maximum protection during transport and storage, and enabling precise piercing when needed.
Data Source
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AI summary
Medical systems, devices and methods are provided for manipulating tissue, such as for closing a perforation in an internal bodily lumen. One embodiment of a medical system generally includes an endoscope, an endcap attached to the distal end of the endoscope, a plurality of needles attached to the endcap, a stylet cap slidably disposed of the endcap, a plurality of stylets attached to the stylet cap, and a plurality of tissue devices. The plurality of needles define a plurality of needle lumens and the plurality of stylets project distally into the needle lumens. The plurality of tissue devices are positioned within the needle lumens, whereby translation of the stylet cap relative to the endcap causes the plurality of stylets to engage the plurality to tissue devices and eject them from the plurality of needles. The medical system may further include a protective tip slidably attached to the plurality of needles.