Cryogenic Catheter Probe for Selective GI Mucosal Ablation
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Solution Overview
Problem
Existing medical treatments for conditions like Type 2 diabetes and obesity, such as gastric-bypass surgery and endoscopic interventions, carry significant risks and adverse events, while current ablative techniques like radiofrequency ablation and laser ablation cause unintended tissue damage and high inflammatory responses.
Innovation Solution
A cryogenic catheter probe and system that selectively ablates mucosal and submucosal tissues in the gastrointestinal tract using cryogenic fluid delivery channels and sprayers, preserving critical microvasculature and nerve structures for tissue regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high-temperature ablation (RFA, microwave, laser) is used to ablate tissue, then ablation effectiveness is improved, but unintended tissue damage and inflammatory response increase
Solution Approach 1:
The patent changes the fundamental parameter of ablation from high temperature to low temperature (cryogenic) range. By using temperatures below freezing point instead of high temperatures, the method achieves effective tissue ablation while avoiding the coagulative denaturation and severe inflammatory responses associated with thermal ablation methods.
Solution Approach 2:
The patent utilizes phase transitions of water (freezing and thawing cycles) as the mechanism for tissue ablation. The freeze-thaw process creates intracellular ice crystals that damage cellular structures while preserving the extracellular matrix, enabling effective ablation with minimal unintended damage to surrounding tissue.
2Reliability
If gastric-bypass surgery is performed to treat diabetes and obesity, then glycemic control is improved, but surgical morbidity and mortality increase
Solution Approach 1:
The patent replaces the mechanical/surgical intervention of gastric-bypass surgery with a minimally invasive endoscopic procedure. Instead of performing major surgical anastomosis, the invention uses endoscopic delivery of cryogenic ablation to achieve similar metabolic benefits through tissue remodeling, thereby eliminating surgical morbidity and mortality risks.
Solution Approach 2:
The patent introduces an endoscopic delivery system as an intermediary between the treatment goal and the patient's anatomy. This intermediary allows for precise delivery of cryogenic ablation therapy to target tissues without requiring open surgery, bridging the gap between effective treatment and patient safety.
3Object-affected harmful factors
If cryoablation is used to ablate tissue, then inflammatory response is minimized, but ablation depth control becomes challenging
Solution Approach 1:
The patent segments the ablation process into multiple controlled freeze-thaw cycles, each targeting specific tissue depths. By dividing the treatment into discrete stages and using multiple applicators with different contact pressures and durations, precise depth control is achieved while maintaining the low inflammatory response benefit of cryoablation.
Solution Approach 2:
The patent implements feedback control mechanisms to monitor and adjust the cryogenic ablation process in real-time. Temperature sensors and pressure monitoring provide feedback that allows dynamic adjustment of ablation parameters, ensuring precise depth control while maintaining minimal inflammatory response.
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
Minimizes tissue damage and inflammatory response, enabling effective glycemic control and tissue remodeling with reduced adverse events, mimicking the benefits of bariatric surgery without surgical morbidity.
Implementation Method 1
The application of freezing temperature to tissue or cryoablation forms intracellular ice crystals which result in damage to cellular organelles and plasma membrane
Implementation Method 2
A cryogenic catheter probe and system that selectively ablates mucosal and submucosal tissues in the gastrointestinal tract using cryogenic fluid delivery channels and sprayers
Data Source
AI summary
Disclosed is a cryogenic catheter probe, cryogenic ablation system, and use thereof for performing cryogenic ablation of mucosal tissue and/or of both mucosal tissue and submucosal tissue in the gastrointestinal tract of a subject. The cryogenic catheter probe includes a chamber and a channel assembly housed within the chamber. The channel assembly includes a central rail, at least one cryogenic fluid delivery channel, a delivery channel guide, and a sprayer guide. The at least one cryogenic fluid delivery channel has a fluid delivery channel portion and a sprayer connected to the fluid delivery channel portion, and is mounted on the central rail for longitudinal movement along the central rail. The sprayer is configured to release cryogenic spray in at least one treatment zone along the hollow body portion of the chamber.