Endoluminal Cryoballoon with Dynamic Inflation Control
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Solution Overview
Problem
Existing medical devices, such as balloon catheters, face challenges in effectively treating tissue regions due to varying thermal loads and dimensions in vascular environments, limiting their applicability across different patients and procedures.
Innovation Solution
A system with an expandable balloon element that allows for controlled size, shape, and dimension modification during use, along with real-time monitoring and regulation of fluid delivery to achieve target pressures, temperatures, and flow rates, ensuring safe and effective tissue treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a balloon catheter is manufactured with fixed dimensions for a specific application, then the device can be effectively used for that particular procedure, but it cannot be suitable for similar applications in patients with different tissue dimensions
Solution Approach 1:
The balloon catheter incorporates an expandable balloon that can be inflated to different volumes during the procedure. The balloon is constructed with materials and structural features that allow dynamic expansion from a compressed delivery state to various expanded treatment states, enabling a single device to adapt to different patient anatomies and treatment requirements
Solution Approach 2:
The device allows modification of the balloon's dimensional parameters (volume, shape, expansion ratio) during use through controlled fluid or gas delivery. This enables the same catheter to be adjusted for different patient sizes and treatment needs, replacing the need for multiple fixed-size catheters
2Adaptability or versatility
If thermally-based procedures are performed in blood vessels with varying thermal loads, then the treatment can reach different tissue locations, but the unpredictable thermal load greatly alters the efficacy of the device and its ability to deliver desired therapy
Solution Approach 1:
The system incorporates temperature sensors that continuously monitor the thermal environment within the balloon and along the catheter shaft. This feedback information is used to adjust the thermal delivery parameters in real-time, compensating for variations in blood flow and tissue thermal properties to maintain reliable and effective treatment across different anatomical locations
Solution Approach 2:
The balloon acts as a thermal intermediary that isolates the thermal treatment zone from the flowing blood. By occluding the vessel and creating a contained environment, the balloon mediates between the thermal energy source and the target tissue, reducing the influence of varying blood flow thermal loads on treatment efficacy
3Reliability
If the balloon is inflated to substantially occlude the blood vessel, then effective thermal treatment can be delivered, but the varying dimensions of blood vessels and endoluminal tissues make it difficult to achieve proper occlusion without knowing the vessel size in advance
Solution Approach 1:
The balloon is designed with dynamic expandability, allowing it to be inflated progressively to match the dimensions of the host vessel. This dynamic adaptation enables reliable occlusion across a range of vessel sizes using a single catheter platform, eliminating the need for multiple pre-specified size catheters
Solution Approach 2:
The catheter system is designed with universal applicability through the expandable balloon that can accommodate different vessel diameters. The same catheter can be used across multiple patient populations and vessel types by adjusting the inflation volume, providing a universal solution rather than requiring size-specific devices
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 precise and adaptable thermal treatment of tissue regions by correlating measured parameters with inflated dimensions, ensuring effective occlusion and ablation while minimizing the risk of complications from varying environmental conditions.
Implementation Method 1
delivering a fluid to the expandable element such that the expandable element is inflated to substantially occlude the blood vessel
Implementation Method 2
thermally affecting the blood vessel with the expandable element... ablating a portion of the blood vessel
Data Source
AI summary
A method of ablating tissue is provided, including positioning an expandable element of a catheter in a blood vessel; inflating the expandable element with a volume of refrigerant to substantially occlude the blood vessel; measuring the volume of refrigerant used to inflate the expandable element; correlating the measured volume to an inflated dimension of the expandable element; defining at least one of a target pressure within the expandable element and a target flow rate for refrigerant delivery to the expandable element based at least in part on the inflated dimension; regulating refrigerant delivery to the expandable element to attain the at least one defined target pressure within the expandable element or defined target flow rate for fluid delivery to the expandable element; and ablating at least a portion of the blood vessel with the expandable element.