Triple Balloon Catheter for Left Atrium Cryoablation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing minimally invasive cardiovascular treatment methods face challenges in maintaining device position and achieving uniform tissue contact due to the irregular topography of the heart's chambers and the difficulty in creating large, unbroken lesion areas, especially in the left atrium, where the risk of injury to surrounding tissues is high.
Innovation Solution
A cryotherapy device with a catheter body and expandable ablation elements, including balloons with varying elastic moduli, allows for secure placement and large-area tissue ablation in the left atrium, minimizing the risk of injury by conforming to uneven surfaces and enabling the creation of non-annular lesions without the need for precise alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a loop-shaped ablation element is used to create uniform lesions, then the intended result is a substantially uniform circle of ablated tissue, but uniform, unbroken lesion lines are hard to create and precise alignment is very difficult to achieve due to moving tissue and flowing blood
Solution Approach 1:
The patent employs a flexible balloon catheter that can be inflated to conform to the irregular surfaces of cardiac tissue. The balloon's flexibility allows it to adapt to the moving tissue and flowing blood environment, maintaining contact without requiring precise alignment, thereby solving the contradiction between lesion uniformity and ease of positioning
Solution Approach 2:
The patent changes the physical state of the ablation element from a rigid loop structure to an inflatable balloon that can change its shape and size. By controlling the inflation parameter, the balloon can be expanded to match the tissue surface geometry, achieving uniform tissue contact and lesion creation without requiring precise initial positioning
2Manufacturing precision
If a laser or RF catheter is used to ablate tissue, then a narrow lesion is formed corresponding to the width of the catheter, but precise alignment is very important and very difficult to achieve due to the narrow ablation width
Solution Approach 1:
The patent transitions from a one-dimensional narrow catheter tip ablation to a two-dimensional surface ablation using an inflatable balloon. The balloon expands in the radial dimension, creating a broader contact surface with the tissue, which allows for larger lesion areas without requiring the same level of alignment precision as narrow-catheter methods
3Area of stationary object
If cryogenic ablation is used to create large area lesions, then large contiguous lesions can be created, but the device must conform to uneven surface topography to ensure uniform contact
Solution Approach 1:
The patent uses a flexible balloon that can be inflated to conform to the uneven surface topography of the cardiac tissue. The balloon's ability to deform and adapt to the irregular surface ensures uniform contact across large areas, enabling creation of large contiguous lesions while maintaining surface conformity
Solution Approach 2:
The patent employs a dynamically adjustable balloon that can be inflated or deflated as needed. This dynamic capability allows the balloon to adapt to different tissue geometries and maintain optimal contact pressure across varying surface topographies, ensuring uniform cryogenic ablation over large areas
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 device effectively modifies electrophysiological properties of cardiac tissue by creating large, contiguous lesions in the left atrium, reducing the risk of tissue injury and improving treatment outcomes for conditions like atrial fibrillation without the need for heart arrest.
Implementation Method 1
a first balloon (150) disposed on the elongate body of the catheter (34)... suitable for cooling the ablation element (38) to a temperature sufficient to freeze tissue
Implementation Method 2
the first balloon (150)... having a first elastic modulus... suitable for cooling the ablation element (38) to a temperature sufficient to freeze tissue
Implementation Method 3
a second balloon (152) located distal to the first balloon (150)... having a second elastic modulus... when inflated, the second balloon (152) occludes a pulmonary vein (142)
Implementation Method 4
a third balloon (164) surrounding the first and second balloons to define an interstitial region therebetween... having a third elastic modulus
Data Source
AI summary
The present invention advantageously provides a method and system for cryogenically ablating large areas of tissue within the left atrium. In an exemplary embodiment a cryotherapy device includes a catheter body, a proximal end and a distal end; a first lumen; a second lumen; and an ablation element expandable from a first diameter to a second diameter, the ablation element having a surface portion that conforms to the uneven surface topography of the cardiac tissue. The ablation element can include one or more deformable balloon and/or flexible elements. The surface of the balloon can further be shaped by regulation of pressure within the one or more balloons. In an exemplary method, a tissue ablation device is provided and tissue in the left atrium is ablated with the device, whereby the ablation is created by freezing tissue.