Helical Suture Anchor Deployment for Precise Endoscopic Tissue Approximation
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Solution Overview
Problem
Existing endoscopic procedures for treating gastrointestinal bleeding and perforations lack a less complex solution that allows precise placement of hemostasis clips or sutures without requiring modification of standard endoscopes, and current systems are bulky, difficult to maneuver, and prone to misalignment or unintended tissue damage.
Innovation Solution
A suture anchor deployment system with helical portions that pierce and engage tissue, allowing precise placement and repositioning of suture anchors through a conventional endoscope's working channel, using a deployment system that includes a delivery member with a rotatable shaft and sheath for controlled deployment and repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a suturing device is used to control GI bleeding and perforations, then hemostasis and tissue closure can be achieved, but the system becomes complex and requires a specialized two channel therapeutic endoscope which is not widely available
Solution Approach 1:
The device is divided into separate functional modules: a delivery system for deploying individual T-fasteners, and a separate cinching system for tightening sutures. This segmentation allows each module to be simpler and more specialized, reducing overall system complexity while maintaining effective hemostasis control capability
Solution Approach 2:
The T-fastener delivery system can be used for multiple purposes: controlling GI bleeding, closing perforations, and performing tissue reconfiguring procedures. This multi-functionality eliminates the need for specialized two-channel endoscopes, as a single standard endoscope can support all these applications
2Reliability
If hemostasis clips are used to achieve hemostasis, then compressive force can be applied to the bleed site, but the clips are difficult to precisely position with respect to a lesion and once fired they lack the ability to be removed and repositioned
Solution Approach 1:
The T-fastener delivery system allows dynamic adjustment and repositioning before deployment. The operator can position the T-fastener, evaluate placement accuracy, and if needed, remove and reposition it without committing to a fixed placement, unlike traditional fired clips
Solution Approach 2:
The T-fastener acts as an intermediary device that combines features of both clips and sutures. It provides immediate compressive force like a clip but maintains flexibility for adjustment, serving as a mediator between the need for immediate hemostasis and the need for precise positioning
3Reliability
If a belt with multiple T-fasteners is rotated to deploy fasteners sequentially, then tissue approximation can be achieved, but the instrument becomes bulky and less maneuverable in tight spaces
Solution Approach 1:
The T-fastener is extracted from the rotating belt configuration and deployed individually through a slender delivery catheter. This extraction eliminates the need for a bulky rotating mechanism, allowing the instrument to navigate tight spaces while still achieving effective tissue approximation through sequential deployment of individual fasteners
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
Enables precise and flexible deployment of suture anchors for tissue approximation and reconfiguration without modifying the endoscope, improving maneuverability and reducing the risk of unintended tissue damage, while allowing for various therapeutic treatments.
Implementation Method 1
The suture anchor includes a distal helical coil portion... Rotation of the delivery system causes the helical coil portion to engage the tissue
Data Source
Figure 1~2
Figure 3~4A
Figure 4B~4C
AI summary
A deployment system includes a sheath, a torque able shaft having a handle positioned at its proximal end, a detachable helical first suture anchor positioned at the shafts distal end and an elongate suture fixedly coupled to the suture anchor. The deployment system can he positioned at a first tissue, and the shaft rotated to advance the helical first suture anchor into engagement with the first tissue. The shaft is detached from the first suture anchor thereby deploying it at the first tissue location. Then, the deployment system is removed from the patient, and a second suture anchor is coupled to the distal end of the shaft. The deployment system is re-inserted into the patient and the distal end of the system is moved adjacent a second tissue location, and the process is repeated for a second suture anchor at the second tissue location. A suture extends between the first and second fasteners, and tension is applied to the suture to draw the first and second tissues toward each other to reconfigure the tissue.