Gallbladder Cryoablation Catheter for Controlled Defunctionalization
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Solution Overview
Problem
Existing medical ablation technologies are ineffective for large, high-surface area tissue targets like the gallbladder, leading to complications such as ice build-up and injury during procedures, and lack a definitive, minimally invasive treatment for gallstone disease in high-risk patients.
Innovation Solution
A catheter-based cryoablation system with pressure and temperature control mechanisms, including a control unit, outer and inner shafts, and sensors, to safely disperse a cryogenic ablation medium within the gallbladder lumen, maintaining intraluminal pressure and evacuating excess medium to prevent complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If a generic cryogen spray is used for high-surface area tissue ablation, then ablation coverage is improved, but safety and effectiveness are worsened due to ice build-up and complications
Solution Approach 1:
The device segments the ablation process by separating cryogen delivery (inner shaft) from evacuation (outer shaft), allowing independent control of each function. This segmentation enables precise management of cryogen distribution and removal, preventing ice build-up while maintaining effective ablation coverage of the gallbladder lumen.
Solution Approach 2:
The device incorporates pressure sensors that provide real-time feedback on intraluminal pressure conditions. This feedback mechanism allows the system to monitor and adjust cryogen delivery and evacuation rates dynamically, preventing harmful ice accumulation while ensuring effective ablation throughout the treatment area.
2Reliability
If cryogen is delivered into a closed lumen like the gallbladder, then ablation effectiveness is improved, but harmful ice build-up occurs worsening safety
Solution Approach 1:
The device extracts excess cryogen and ice formations from the gallbladder lumen through the outer shaft evacuation system. This continuous removal process prevents harmful ice build-up while maintaining the cryogenic conditions necessary for effective ablation of the target tissue.
Solution Approach 2:
The device changes the physical parameters of the cryogen by controlling temperature, pressure, and phase transitions. Pressure sensors monitor these parameter changes in real-time, allowing the system to adjust cryogen delivery and evacuation to maintain optimal ablation conditions while preventing ice accumulation.
3Manufacturing precision
If existing ablation technologies are used for gallbladder treatment, then some tissue ablation is achieved, but the treatment is ineffective for large high-surface area targets
Solution Approach 1:
The device transitions from traditional point-by-point ablation to a distributed multi-orifice approach, delivering cryogen through multiple openings along the inner shaft. This dimensional change enables simultaneous treatment of large surface areas while maintaining precise depth control through regulated cryogen flow and pressure management.
4Reliability
If surgical removal of gallbladder is performed, then definitive treatment is achieved, but surgical complications and risks occur
Solution Approach 1:
The device replaces mechanical surgical removal with a minimally invasive cryoablation system. This substitution delivers definitive treatment through controlled freezing and destruction of gallbladder tissue via the catheter system, eliminating the need for open surgery and associated surgical complications while achieving the same therapeutic goal.
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 ablates and defunctionalizes the gallbladder, reducing health risks and healthcare costs by providing a minimally invasive, long-term solution for gallstone disease without surgical complications.
Implementation Method 1
the nozzle configured to distribute the ablation medium throughout the body lumen such that the ablation medium contacts and ablates tissue within the body lumen
Implementation Method 2
the first pressure lumen configured to couple a first pressure sensor disposed proximal to the shaft to the body lumen such that the first pressure sensor can measure an intraluminal pressure of the body lumen
Implementation Method 3
a second pressure lumen having a distal opening that terminates in an evacuation lumen configured to evacuate a portion of the ablation medium from the body lumen
Data Source
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AI summary
Provided herein are catheter devices, systems, and methods to ablate a tissue location. The devises, systems, and methods disclosed herein include ablation systems including a catheter system with inner and outer shafts that deliver an ablation medium (e.g., a cryogenic ablation medium) to a body lumen and evacuate the ablation medium from the body lumen. In some embodiments, devices, systems, and methods disclose herein relate to monitoring and regulating pressure, temperature, or other conditions within a body lumen during an ablation procedure.