Flexible Endoscopic Tissue Fastening for Tortuous Anatomy
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Solution Overview
Problem
Existing medical staplers, particularly those used in laparoscopic and endoscopic procedures, face challenges in navigating tortuous anatomy without causing tissue trauma due to their rigid structure.
Innovation Solution
A flexible and modular stapling mechanism integrated with an endoscope, featuring a coupling body, cartridge holder, and anvil, which allows for the deployment of staples and optional cutting of tissue, with components that can be easily replaced through the endoscope's working channel, minimizing tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a rigid stapler is used for tissue closure, then the stapling function is effective, but the device cannot navigate tortuous anatomy without causing tissue trauma
Solution Approach 1:
The stapler is divided into modular components including a handle assembly, a flexible shaft, and replaceable cartridges. The flexible shaft is segmented into multiple articulation sections that can bend independently, allowing the device to navigate tortuous anatomy while maintaining stapling functionality at the distal end.
Solution Approach 2:
The stapler incorporates a flexible shaft constructed from multiple flexible segments that can bend and articulate to follow the contours of body lumens. This flexible construction allows the device to navigate complex anatomical pathways without causing tissue trauma, while the distal end maintains sufficient rigidity to perform stapling operations.
2Length of moving object
If a long rigid stapler is used to reach distant tissue, then the stapling reach is extended, but the device causes trauma to tissue during navigation
Solution Approach 1:
The long device is segmented into multiple flexible sections along its length, allowing each section to articulate independently. This enables the device to reach distant tissue targets while bending to follow anatomical pathways, preventing the tissue trauma that would result from forcing a rigid long device through tortuous anatomy.
Solution Approach 2:
The flexible shaft is designed with curved articulation capabilities, allowing the device to follow the natural curves and bends of body lumens. This curved navigation capability enables the device to reach distant targets without causing trauma, as it can adapt to the existing anatomical curvature rather than forcing a straight path.
3Ease of manufacture
If reusable staplers are used, then the device cost is reduced, but the device cannot be easily sterilized and may harbor contaminants
Solution Approach 1:
The stapler incorporates disposable cartridges containing staples and cutting blades that are replaced after each use. These single-use cartridges can be sterilized or disposed of, eliminating the risk of contamination from previous procedures. The reusable handle assembly can be sterilized between uses, combining the cost benefits of reusability with the safety of disposable components.
Solution Approach 2:
The potentially contaminating components (staple cartridges and cutting blades) are extracted as separate replaceable units from the handle assembly. This allows the critical sterilization function to be applied to the disposable cartridges through sterilization processes or single-use disposal, while the expensive handle assembly can be thoroughly sterilized and reused without risk of harboring contaminants.
4Adaptability or versatility
If the entire stapler is removed and reinserted to replace cartridges, then fresh cartridges are available, but the procedure time increases and patient irritation increases
Solution Approach 1:
The cartridge replacement mechanism is nested within the existing device structure, allowing cartridges to be exchanged through the working channel of the endoscope or through a access port. The replacement process utilizes the existing device lumen and mechanisms, eliminating the need for complete removal and reinsertion of the stapler, thus reducing procedure time and patient irritation.
Solution Approach 2:
An intermediary access mechanism is provided that allows cartridge replacement without complete device removal. This may include a side-port access system or a working channel-based replacement mechanism that serves as an intermediary pathway for cartridge exchange, maintaining the benefits of fresh cartridges while avoiding the time loss and patient irritation associated with full device removal.
Data Source
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Figure 4A~6B
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AI summary
Accord ing to one aspect, a fastening device may include a coupling body having (1) a portion configured to couple to a distal end of a medical device, (2) a cartridge holder, and (3) an anvil pivotably coupled to the cartridge holder. The cartridge holder and the anvil may extend distally from the portion and may be configured to extend distally of a distalmost face of the medical device when the portion is coupled to the distal end of the medical device. A flexible member may be configured to extend through a channel of the medical device. A fastener cartridge may be coupled to a distal end of the flexible member, including at least one fastener, and may be configured for releasable coupling to the cartridge holder.