Cryoballoon Constrained by Deflecting Balloon for Selective Ablation
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Solution Overview
Problem
Current cryotherapy devices for treating anatomical vessels lack the ability to perform partial circumferential or non-continuous ablation, which can cause unnecessary structural changes to the vessels, and there is a need for more precise control over the ablation area to treat conditions like hypertension and arrhythmia effectively.
Innovation Solution
The use of a dual-balloon catheter system where a cryoballoon is paired with a constraining balloon that deflects the cryoballoon away from non-target tissue, allowing for partial circumferential or helical ablation patterns by limiting the contact surface arc of the cryoballoon to between 45° and 225° of the vessel wall, thereby reducing structural changes and enhancing treatment precision.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a cryoballoon is expanded within an anatomical vessel to perform cryogenic ablation, then the ablation effectiveness is improved, but the risk of unnecessary structural changes to the vessel wall increases when full circumferential ablation occurs
Solution Approach 1:
The cryoballoon is divided into multiple independent segments or zones along its circumference. Each segment can be independently controlled to contact or deflect from the vessel wall, allowing selective ablation of specific areas while preserving other areas, thus achieving partial circumferential ablation patterns that reduce unnecessary structural changes.
Solution Approach 2:
Different portions of the cryoballoon are given different functional properties. Some segments are designed to contact the vessel wall for ablation, while other segments are designed to deflect away or provide cooling protection. This local differentiation allows precise control over where ablation occurs and where it is protected, reducing harmful structural changes.
2Adaptability or versatility
If a cryoballoon is used for cryogenic ablation, then the treatment capability is improved, but the precision of ablation area control is insufficient
Solution Approach 1:
The cryoballoon incorporates movable or adjustable components that allow dynamic reconfiguration of the ablation pattern during the procedure. The balloon can transition between different contact configurations, enabling the operator to precisely control the ablation area size and shape to match the specific treatment requirements, thereby improving ablation area control precision.
Solution Approach 2:
A constraining element or deflection mechanism is introduced as an intermediary between the cryoballoon and the vessel wall. This intermediary controls which portions of the cryoballoon contact the vessel wall, providing precise control over the ablation area while maintaining the overall treatment capability of the cryoballoon system.
3Manufacturing precision
If a dual-balloon catheter system is used with a constraining balloon to deflect the cryoballoon, then the precision of ablation targeting is improved, but the device complexity increases
Solution Approach 1:
The constraining balloon and cryoballoon are merged into a single integrated dual-balloon catheter system with shared control mechanisms and fluid delivery systems. This integration reduces the number of separate components and control systems needed, thereby reducing device complexity while maintaining the precision ablation targeting capability provided by the constraining balloon.
Solution Approach 2:
The constraining balloon serves multiple functions: it deflects the cryoballoon away from non-target areas, provides structural support for the catheter system, and can potentially serve as a delivery mechanism for the cryoballoon. This multi-functionality reduces the need for additional separate components, thereby reducing device complexity while maintaining precision targeting.
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
This approach enables effective neuromodulation with reduced structural impact on the vessels, improving treatment outcomes for conditions such as hypertension and arrhythmia by allowing for targeted cryogenic cooling while protecting non-target tissues from ablation.
Implementation Method 1
cryogenic cooling of a targeted area of an inner surface of an anatomical vessel or other tissue
Implementation Method 2
a constraining balloon that deflects the cryoballoon away from non-target tissue
Data Source
AI summary
Embodiments related to cryogenically ablating a portion of the inner surface of a vessel by constraining a cryoballoon using various apparatuses and methods are disclosed. For example, a catheter can include a cryoballoon for ablation of the vessel wall and a constraining element disposed substantially in parallel with the cryoballoon to deflect or offset a portion of the cryoballoon away from non-target tissue of the vessel wall and prevent ablation of the non-target tissue. Partial circumferential, non-continuous, or helical ablation can be effective for treating a variety of renal, cardio-renal, and other diseases including but not limited to hypertension, heart failure, renal disease, renal failure, contrast nephropathy, arrhythmia, and myocardial infarction. The constraining element may be, for example, a second inflatable balloon or one or more self-expanding prongs.