Multi-Lobe Cryoballoon Adaptation for Pulmonary Vein Morphologies
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Solution Overview
Problem
Existing cryoballoon catheters fail to accommodate the wide variability in pulmonary vein morphologies, necessitating additional focal or RF catheter ablation, which poses safety risks and increases procedure time.
Innovation Solution
A cryotreatment catheter with an adjustable balloon treatment element featuring multiple radially arranged lobes, allowing independent inflation and deflation, and an inner elongate body that can obstruct or unobstruct apertures for precise fluid delivery and ablation, accommodating various pulmonary vein morphologies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a one-size-fits-all cryoballoon catheter is used, then the device structure is simple, but it cannot accommodate the wide variability in pulmonary vein morphologies, requiring additional focal or RF catheter ablation
Solution Approach 1:
The balloon is divided into multiple independent lobes (typically 3-6 lobes) that can be selectively inflated or deflated. Each lobe can be independently controlled through separate inflation lumens, allowing the balloon to adapt to various pulmonary vein morphologies including asymmetric shapes, without requiring a completely different device design.
Solution Approach 2:
The balloon transitions from a static, fixed-shape design to a dynamic, adjustable configuration. The inner elongate body can rotate and translate within the outer elongate body, enabling selective engagement of different lobe sets (first set vs. second set) to match different vein orientations and shapes during the procedure.
2Reliability
If additional focal or RF catheter ablation is performed after cryoablation, then complete ablation coverage is achieved, but procedure time increases and safety risks are posed to the patient
Solution Approach 1:
The multi-lobe balloon is designed to achieve complete circumferential ablation coverage in a single procedure by selectively inflating appropriate lobes before the ablation process begins. The ability to pre-position and shape the balloon to match the specific pulmonary vein morphology ensures that the initial cryoablation pass achieves complete coverage, eliminating the need for subsequent touch-up procedures.
3Reliability
If additional focal or RF catheter ablation is performed after cryoablation, then complete ablation coverage is achieved, but safety risks are increased due to multiple catheter interventions
Solution Approach 1:
The balloon is pre-configured with multiple lobe sets that can be selectively engaged to match different pulmonary vein morphologies before the ablation procedure begins. This preliminary adaptation ensures complete coverage is achieved during the single cryoablation pass, avoiding the need for additional catheter interventions that expose patients to repeated vascular access risks, endocardial trauma, and procedural complications.
4Adaptability or versatility
If a fixed-balloon design is used, then manufacturing is simple, but it cannot accommodate various pulmonary vein diameters, cross-sectional areas, and shapes
Solution Approach 1:
The balloon is constructed as an assembly of multiple modular lobes that can be manufactured using standardized techniques and then combined. Each lobe can be produced independently and then assembled into the final multi-lobe structure, simplifying the manufacturing process while enabling greater adaptability to different vein morphologies.
Solution Approach 2:
The multi-lobe balloon is nested within an inner elongate body that rotates within an outer elongate body. This nested configuration allows the complex multi-lobe structure to be delivered through standard catheter access routes and then deployed in the target location, maintaining ease of delivery and deployment while achieving complex adaptive shapes.
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 tissue ablation without the need for additional catheters, reducing procedure time and safety risks by adapting to diverse vein shapes and sizes.
Implementation Method 1
A cryotreatment catheter may generally include an elongate body including a distal portion, a proximal portion, and lumen therebetween, and a balloon treatment element coupled to the distal portion of the elongate body... adapting to diverse vein shapes and sizes for precise tissue ablation
Data Source
AI summary
A cryotreatment catheter for treating tissue. The catheter may include an outer elongate body, a balloon treatment element coupled to the distal portion of the elongate body with a plurality of balloon lobes radially arranged around the outer elongate body, an inner elongate body rotatably movable within the lumen of the outer elongate body, and a fluid delivery lumen located within the lumen of the outer elongate body and at least partially within the lumen of the inner elongate body. The fluid delivery lumen may be branched at a distal portion into a plurality of linear segments, each linear segment being in fluid communication with one of the plurality of balloon lobes. Each of the balloon lobes may be inflated independently of each other by the linear segments of the fluid delivery lumen.