Helical Tissue Anchor Delivery System for Endoscopic Defect Closure
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Solution Overview
Problem
Current endoscopic clipping devices are limited in their ability to close defects of varying sizes and angles due to fixed prong distances and relationships, and they often fail to penetrate deep tissue layers, leading to sub-therapeutic closure and tissue damage.
Innovation Solution
A delivery system deploying two or more helical tissue anchors through an endoscope, with independent control and rotational manipulation, allowing for full-thickness tissue capture and closure of defects of any size, using a multi-lumen catheter with a handle assembly for precise deployment and suture mechanism to close the treatment area.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If metallic clipping devices with fixed prong distance are used, then the device structure is simple, but the ability to close defects of varying sizes is limited
Solution Approach 1:
The device divides the single clip into multiple independent anchors (first anchor, second anchor, third anchor) that can be deployed and positioned separately. Each anchor operates independently with its own deployment mechanism, allowing the system to adapt to defects of varying sizes and configurations without requiring a completely different device structure.
Solution Approach 2:
The device transitions from a static fixed-prong clip to a dynamic system where anchors can be deployed, repositioned, and adjusted independently. The handles allow for controlled advancement and release of each anchor, enabling adaptive positioning based on the specific defect characteristics during the procedure.
2Adaptability or versatility
If metallic clipping devices with fixed prong relationship are used, then the device is easy to operate, but the ability to position clips appropriately in relation to the area needing treatment is limited
Solution Approach 1:
The single clip unit is segmented into multiple independent anchors, each with its own handle control. This allows the operator to position and deploy each anchor independently at optimal locations relative to the defect, rather than being constrained by a fixed relationship between prongs.
Solution Approach 2:
The device allows for preliminary positioning and deployment of anchors before final closure is achieved. Each anchor can be advanced and positioned in advance, then secured independently, allowing the operator to plan and adjust the overall configuration based on real-time visualization of the defect.
3Reliability
If metallic clipping devices are used, then the device structure is simple, but the legs cannot be actuated and anchored at different times, resulting in sub-therapeutic closure or tissue damage
Solution Approach 1:
The single actuation mechanism is segmented into multiple independent actuation controls (first handle, second handle, third handle), each capable of advancing and anchoring its corresponding anchor at different times and in different sequences. This independent actuation allows for controlled, staged closure that improves reliability while avoiding tissue damage from simultaneous or forced anchoring.
4Adaptability or versatility
If present clipping devices are used, then the device is simple, but the legs must be actuated and anchored simultaneously, limiting the ability to apply unequal pressure
Solution Approach 1:
The actuation system is segmented into independent handle mechanisms for each anchor, allowing the operator to apply different forces, timing, and sequences to each anchor based on the specific tissue characteristics and defect requirements. This enables unequal pressure application to optimize closure quality.
Solution Approach 2:
The system allows for dynamic adjustment of actuation timing and force application for each anchor independently. The operator can advance and anchor anchors in any sequence, applying different pressures as needed, rather than being constrained by simultaneous actuation of all legs.
5Strength
If present clipping devices are used, then the device structure is simple, but the clips cannot penetrate into deeper wall layers (submucosa and muscular propria layers)
Solution Approach 1:
The single clip structure is segmented into multiple anchors with independent deployment capabilities. Each anchor can be advanced and positioned to engage with deeper tissue layers independently, allowing for full-thickness penetration and secure anchoring in the submucosa and muscular propria layers without requiring a completely redesigned overall device structure.
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 effective repair of large perforations and lesions with precise control, facilitating full-thickness tissue closure and plication under endoscopic visualization, overcoming the limitations of existing devices by allowing independent deployment and adjustment of anchors.
Implementation Method 1
rotational manipulation, allowing for full-thickness tissue capture and closure of defects of any size
Implementation Method 2
suture mechanism to close the treatment area
Data Source
AI summary
A delivery system for delivering a plurality of helical tissue anchors to repair a wall defect. Coaxially contained within the outer sheath are inner tubular members. The first inner tubular member designed to deploy a first helical tissue anchor, a second inner tubular member designed to deploy a second helical tissue anchor, and a centered inner tubular member contains a cinching mechanism. The two helical tissue anchors are connected to a suture or strap that pull the two helical tissue anchors together to close a tissue defect. A cinching mechanism holds the anchors and tissue defect together and cut the suture or strap.