Leadless Pacemaker Retrieval Device with Wire Loops
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Solution Overview
Problem
Existing medical devices and delivery systems for leadless cardiac pacing devices face challenges in efficient implantation and retrieval, particularly in engaging and disengaging the devices from cardiac tissue without causing damage.
Innovation Solution
A device comprising a first elongate shaft, a second elongate shaft slidably disposed within the first, an end cap assembly with an insert and outer housing, and a plurality of wires extending from the end cap assembly to engage the proximal hub of the leadless cardiac pacing device, facilitating its implantation and retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a catheter-based delivery system is used for implantation and retrieval, then the leadless cardiac pacing device can be delivered to and retrieved from the heart, but the complexity of the delivery system increases and manipulation difficulty arises
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery catheter for advancement, a retrieval device with snare assembly for capture, and a hub structure on the leadless pacemaker for engagement. This segmentation allows each component to be optimized independently, reducing overall system complexity while maintaining ease of operation.
Solution Approach 2:
A hub structure is introduced as an intermediary component between the leadless pacemaker and the delivery/retrieval devices. The hub includes engagement features that interface with both the delivery catheter and retrieval device, simplifying the interaction mechanisms and reducing manipulation difficulty.
2Reliability
If a snare assembly with multiple snare legs is used to capture the leadless pacemaker, then capture functionality is improved, but the device complexity and potential for tissue damage increase
Solution Approach 1:
The snare assembly utilizes flexible, thin-walled structures that can conform to the leadless pacemaker geometry while applying gentle capture forces. The flexibility of the snare legs allows them to adapt to the device shape without causing mechanical damage, while still providing reliable capture through distributed contact points.
3Ease of operation
If the delivery catheter is made deflectable to improve manipulation, then ease of operation improves, but the risk of tissue damage and loss of control increases
Solution Approach 1:
The delivery catheter incorporates deflectable elements that can be dynamically adjusted during the procedure. The catheter includes a deflectable tip and adjustable curvature mechanisms that allow real-time modification of the catheter shape to navigate cardiac structures while maintaining control to prevent tissue damage.
Data Source
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AI summary
An implantation and/or retrieval device for a leadless cardiac pacing device may include a first elongate shaft including a lumen; a second elongate shaft slidably disposed within the lumen of the first elongate shaft; an end cap assembly fixedly attached to a distal end of the first elongate shaft; and a plurality of wires attached to the second elongate shaft and extending distally from the end cap assembly, the plurality of wires being movable relative to the end cap assembly. The plurality of wires is configured to engage a proximal hub of the leadless cardiac pacing device. The plurality of wires forms a plurality of wire loops extending distally from the end cap assembly.