Electrosurgical Lumen-Apposing Stent for Tissue Ingrowth Control
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Solution Overview
Problem
Existing stents face challenges such as tissue ingrowth, overgrowth, and migration, making removal difficult and increasing the risk of bleeding during placement, with current medical devices and methods failing to adequately address these issues.
Innovation Solution
A lumen-apposing stent system with a polymeric inner and outer liner, featuring anchor members and an electrosurgical generator that energizes the stent to modify tissue at specific portions devoid of the outer liner, allowing for tissue cutting or coagulation modes to facilitate removal and improve anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If electrosurgical cutting is used to open a pathway between body lumens, then a pathway can be created, but bleeding occurs
Solution Approach 1:
The patent applies electrosurgical energy to create a sealed pathway through tissue. The electrosurgical generator delivers controlled electrical energy that simultaneously cuts through tissue and coagulates blood vessels, converting the harmful effect of cutting (bleeding) into a beneficial effect (hemostasis). The stent system with electrosurgical capabilities allows the same device that creates the pathway to seal it, eliminating the need for separate cutting and sealing instruments.
2Reliability
If tissue ingrowth into stent openings occurs, then stent stability improves, but stent removal becomes more difficult
Solution Approach 1:
The patent employs a stent system where the relationship between the stent and surrounding tissue can be dynamically changed. Initially, the stent allows tissue ingrowth for stability, but when removal is needed, electrosurgical energy is applied to reverse the tissue-stent integration. The system transitions from a state of strong tissue attachment to a state where the stent can be easily removed, providing dynamic adaptability throughout the device lifecycle.
Solution Approach 2:
The electrosurgical stent system changes the physical and chemical parameters of the tissue-stent interface. By applying controlled electrical energy, the system modifies tissue properties at the stent-tissue boundary, allowing transition between states of strong attachment (for stability) and easy separation (for removal). This parameter change enables the same stent to provide both long-term stability and removable capability.
3Ease of operation
If insufficient lumen apposing force is provided, then stent placement is easier, but stent migration occurs
Solution Approach 1:
The electrosurgical stent system performs preliminary tissue modification during the placement procedure. As the stent is deployed, electrosurgical energy is applied to create immediate tissue sealing and adhesion at the stent-tissue interface. This preliminary action of energy delivery during placement ensures strong initial anchoring, preventing migration while the stent is being positioned and immediately after deployment.
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
The system effectively modifies tissue to ease stent removal, prevent migration, and enhance anchoring by selectively altering tissue properties through electrosurgical energy, improving hemostasis and reducing complications.
Implementation Method 1
an electrosurgical generator configured to energize the lumen-apposing stent to modify tissue adjacent the at least one portion of the outer surface of the lumen-apposing stent that is devoid of the polymeric outer liner
Data Source
AI summary
An electrosurgical stent system includes a lumen-apposing stent including a tubular body, a proximal anchor member adjacent the proximal end, a distal anchor member adjacent the distal end, a polymeric inner liner, and a polymeric outer liner, wherein at least one portion of the outer surface of the stent is devoid of the outer liner, and an electrosurgical generator configured to energize the stent to modify tissue adjacent the at least one portion of the outer surface of the stent. The electrosurgical generator is configured to selectively operate in a tissue cutting mode and a tissue coagulation mode. A method of modifying tissue includes implanting the stent, positioning a probe adjacent the tubular body, wherein the probe is electrically coupled to the electrosurgical generator, and activating the electrosurgical generator to energize the stent to modify tissue adjacent the at least one portion of the outer surface of the stent.