LAA Ablation Catheter With Occlusive Implant Against Dislodgement
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Solution Overview
Problem
The left atrial appendage (LAA) in patients with atrial fibrillation experiences stagnant blood pooling, leading to thrombi formation, which can break loose and cause stroke or heart attack, and existing medical devices for closing off the LAA are not sufficiently effective or may become dislodged due to electrical contractions.
Innovation Solution
A catheter-based ablation and implant system with expandable members and electrodes delivers energy to ablate the LAA and deploys an occlusive implant to close off the LAA, using direct current energy and potentially pharmacological agents to facilitate endothelization and prevent thrombi formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an occlusive implant is deployed to close off the LAA, then thrombi formation is reduced, but the device may become dislodged due to electrical contractions
Solution Approach 1:
Ablation of the LAA is performed before deploying the occlusive implant to eliminate electrical contractions that would otherwise dislodge the device. The ablation creates a barrier to electrical conduction, preventing the LAA from contracting and moving the implant.
Solution Approach 2:
The patent removes the problematic electrical conduction capability from the LAA through ablation, separating the electrical function from the structural function. This extraction of electrical activity prevents the harmful contractions while the implant provides the occlusive function.
2Reliability
If the LAA is ablated to prevent thrombi formation, then thromboembolic events are reduced, but the procedure complexity increases
Solution Approach 1:
The patent combines ablation and occlusive implant deployment into a single integrated procedure performed through one catheter access. The ablation catheter and implant delivery system are combined, allowing both functions to be performed sequentially without requiring separate procedures or additional vascular access.
Solution Approach 2:
The system performs multiple functions (ablation and occlusion) through a single integrated device platform. The same catheter access and delivery system is used for both ablation energy delivery and implant deployment, making the system multi-functional and reducing overall procedural complexity despite the added therapeutic capability.
3Reliability
If direct current energy is delivered to ablate the LAA, then thrombi formation is prevented, but energy delivery precision must be controlled to avoid damage to surrounding tissue
Solution Approach 1:
The ablation energy is delivered locally to the LAA tissue through contact with the ablation catheter tip or expandable member. The energy application is concentrated at the specific target site (LAA ostium or wall) rather than being distributed broadly, allowing precise ablation of the intended tissue while sparing surrounding structures.
Solution Approach 2:
The ablation catheter or expandable member acts as an intermediary between the energy source and the LAA tissue. This intermediary controls the energy delivery, concentrating it at the tissue interface while providing a barrier that prevents energy from affecting deeper or surrounding tissues. The intermediary structure allows controlled energy transfer to achieve localized ablation.
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 system effectively reduces thrombi formation by ablating the LAA and deploying an occlusive implant, minimizing the risk of thromboembolic events by integrating with the patient's circulatory system through endothelization.
Implementation Method 1
a first set of one or more electrodes arranged within the first expandable member and configured to deliver energy to the tissue region
Implementation Method 2
the system may further comprise a direct current source electrically coupled to the first set of one or more electrodes. the direct current source may be configured to deliver pulses of voltage in the range of about 1000 to about 5000 volts
Data Source
AI summary
An example medical system for ablating and occluding the left atrial appendage is disclosed. The example system includes a catheter sized and shaped for vascular access and including an elongate body extending between a proximal end and a distal end. A first expandable member may be positioned near the distal end of the elongate body and have a first region configured to permeate a liquid therethrough. A first set of one or more electrodes may be arranged within the first expandable member and may be configured to deliver energy to the tissue region. An occlusive implant may be releasably secured to the distal end of the elongate body.