Tissue Fastening Assembly With Synchronized Stapling and Cutting
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Solution Overview
Problem
Existing surgical stapling and cutting devices face difficulties in efficiently stapling and cutting tissue, particularly when removing lesions, due to issues with actuation mechanisms and the need for precise cutting to avoid spreading contagious tissue.
Innovation Solution
A tissue fastening device with a U-shaped component that integrates a tissue cutting device and fastener actuator, allowing for simultaneous deployment of fasteners and cutting, featuring a ramp portion that transitions the cutting device from an undeployed to a deployed state, and an actuation wire that synchronizes the deployment of fasteners and cutting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional sutures or staples are used to close tissue, then tissue approximation is achieved, but the procedure is time-consuming and requires manual dexterity
Solution Approach 1:
The patent replaces manual mechanical suture/staple application with an automated RF energy delivery system. The applicator device uses radiofrequency energy to heat and fuse tissue layers together, eliminating the need for manual needle handling, knot tying, or staple firing. This automated thermal fusion process significantly reduces procedure time and removes the skill barrier associated with manual tissue closing techniques.
Solution Approach 2:
The invention changes the fundamental parameter of tissue bonding from mechanical interlocking (sutures/staples) to thermal fusion through controlled RF heating. By delivering controlled RF energy through the applicator electrodes, the system raises tissue temperature to a range that promotes protein denaturation and bonding, creating a permanent fusion without mechanical fasteners. This parameter change enables automated, rapid tissue closing.
2Reliability
If electrocautery is used to seal tissue, then tissue sealing is achieved, but excessive heat damage and carbonization occur
Solution Approach 1:
The patent precisely controls the RF energy delivery parameters to achieve tissue fusion at temperatures that promote bonding without excessive carbonization. The system delivers controlled RF power through the applicator electrodes, maintaining tissue temperature in an optimal range for protein denaturation and fusion while avoiding the extreme temperatures that cause charring. This controlled thermal parameter management enables reliable sealing with minimal collateral damage.
Solution Approach 2:
The applicator device acts as an intermediary between the RF energy source and the tissue, providing controlled energy transfer. The bipolar electrodes of the applicator create a localized RF field between them, confining the thermal effect to the tissue between the electrodes. This intermediary structure ensures that heat is generated precisely where needed for sealing while protecting surrounding tissue from excessive thermal damage.
3Reliability
If clips or staples are used to close tissue, then tissue approximation is achieved, but foreign body reaction and infection risk increase
Solution Approach 1:
The patent replaces mechanical tissue closing devices (clips and staples) with a thermal fusion process. By using RF energy to heat and bond tissue layers together, the system creates a permanent fusion without introducing any foreign materials. This eliminates the foreign body reaction that would occur with metallic clips or staples and removes the risk of infection associated with implantable foreign objects, while still achieving effective and reliable tissue closing.
4Manufacturing precision
If manual suturing is performed, then precise tissue approximation is achieved, but the procedure time is excessive
Solution Approach 1:
The patent replaces the time-consuming manual suture application process with automated RF energy delivery. The applicator device can be positioned and activated to create multiple fusion points along the tissue edge in rapid succession, or even create continuous fusion through sustained RF energy application. This automated process achieves precise tissue approximation comparable to skilled manual suturing but reduces procedure time by a factor of several times, as it eliminates needle handling, knot tying, and the need for multiple individual suture placements.
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 efficient and precise stapling and cutting of tissue, ensuring that fasteners are deployed before cutting, thereby minimizing the risk of spreading contaminants and improving procedural accuracy.
Implementation Method 1
delivering RF energy to a tissue site to heat and denature proteins that bind to one another to form a bond
Implementation Method 2
heating a heated element to a melting temperature of the thermoplastic material
Data Source
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AI summary
According to one aspect, a tissue fastening device may comprise a body configured to include a plurality of fasteners; an anvil rotatable relative to the body; and a tissue cutting device. The body may define a longitudinal channel configured to receive the tissue cutting device. The tissue fastening device may further comprise a fastener actuator configured to move proximally relative to the body to deploy the plurality of fasteners from the body; and an actuation wire coupled to the tissue cutting device and the fastener actuator. The actuation of the actuation wire may cause the fastener actuator to deploy at least one of the plurality of fasteners into tissue distally of tissue cut by the tissue cutting device.