Left Atrial Appendage Closure With Balloon Ablation and External Sealing
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Solution Overview
Problem
Existing methods for closing the left atrial appendage, such as suturing or occluding, are invasive, risky, or ineffective in preventing thrombus formation, and there is a need for minimally invasive techniques to address this issue.
Innovation Solution
The use of a balloon catheter and closure device system that includes guide elements, a closure assembly, and electrodes for ablating or abrading tissue, allowing for minimally invasive closure and electrical isolation of the left atrial appendage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery is used to close the left atrial appendage, then the closure is effective, but the procedure is invasive and carries significant surgical risks
Solution Approach 1:
The patent replaces the mechanical open-heart surgery approach with an intravascular device-based system. A catheter is inserted through a vein (femoral or jugular) and advanced to the left atrial appendage, where a closure device is deployed. This substitutes the traditional surgical incision and direct manipulation with a minimally invasive percutaneous approach, eliminating the need for sternotomy and cardiopulmonary bypass while achieving the same closure function.
Solution Approach 2:
The patent introduces a guide wire and catheter as intermediary tools to facilitate the closure procedure. The guide wire serves as a conduit to navigate from the peripheral access site to the target location in the left atrial appendage, while the catheter delivers the closure device. These intermediaries enable the minimally invasive delivery of the closure mechanism without requiring direct surgical access to the heart.
2Ease of operation
If a closure device is deployed through a catheter, then the procedure becomes minimally invasive, but the device complexity increases
Solution Approach 1:
The patent divides the closure system into separate functional components: a delivery catheter, a guide wire, and a closure device. The catheter serves as a temporary delivery vehicle that can be removed after deployment, while the closure device remains in place. This segmentation allows each component to be optimized independently - the catheter for ease of delivery and the closure device for effective sealing - while reducing overall system complexity compared to an all-in-one design.
Solution Approach 2:
The patent extracts the closure function from a complex surgical system and concentrates it into a dedicated closure device that can be delivered through a simple catheter. By separating the delivery mechanism (catheter) from the therapeutic function (closure device), the system achieves minimal invasiveness without requiring the entire system to be overly complex. The catheter is a standard, well-understood device, while the closure device contains the specialized sealing mechanism.
3Ease of operation
If traditional occlusion devices are used, then the procedure is less invasive, but they do not effectively prevent all blood flow into the appendage
Solution Approach 1:
The patent applies local quality by concentrating the closure mechanism at the ostium (opening) of the left atrial appendage rather than attempting to occlude the entire appendage structure. The closure device creates a localized seal at the base where the appendage joins the atrium, which is the critical point for preventing blood flow. This localized approach at the ostium is more effective than distributed occlusion methods while maintaining minimal invasiveness.
Solution Approach 2:
The patent performs preliminary actions by first positioning the guide wire and catheter accurately at the ostium of the left atrial appendage before deploying the closure device. The guide wire is advanced under fluoroscopic guidance to the precise target location, and the catheter is positioned to deliver the closure device at the optimal site. This preliminary positioning ensures that when the closure device is deployed, it creates an effective seal at the critical ostial region, preventing residual blood flow while maintaining the minimally invasive approach.
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 method effectively closes the left atrial appendage, reducing thrombus formation risk while minimizing invasiveness and avoiding complications associated with traditional surgical procedures.
Implementation Method 1
inflating the balloon at least partially within the interior of the atrial appendage, and partially closing the closure assembly to pull interior tissue of the atrial appendage into contact with the inflated balloon
Implementation Method 2
ablating the interior tissue of the atrial appendage with the inflated balloon
Implementation Method 3
The ablation element may be an electrode configured to ablate the interior tissue of the atrial appendage
Implementation Method 4
closing the atrial appendage with the closure assembly
Data Source
AI summary
Described here are devices, systems, and methods for closing the left atrial appendage. The methods described here utilize a closure device for closing the left atrial appendage and guides or expandable elements with ablation or abrading elements to ablate or abrade the left atrial appendage. In general, these methods include positioning a balloon at least partially within the atrial appendage, positioning a closure assembly of a closure device around an exterior of the atrial appendage, inflating the balloon, partially closing the closure assembly, ablating the interior tissue of the atrial appendage with the inflated balloon, removing the balloon from the atrial appendage, and closing the atrial appendage with the closure assembly.