Leadless Dual-Chamber Pacemaker Implantation via Sheath Retraction
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Solution Overview
Problem
Current implantable cardiac medical devices with leads outside the heart are prone to infections, Twiddler's syndrome, and limited functional capabilities, particularly lacking dual-chamber pacing and sensing capabilities, and face challenges with wireless communication power consumption and reliability.
Innovation Solution
A leadless intra-cardiac medical device assembly that includes a housing and electrode with anchoring members, deployed using a sheath and push rod/stylet system, allowing for dual-chamber pacing and sensing without external leads, ensuring the device is entirely within the heart, reducing infection risk and improving functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pacemakers with external leads are used, then dual-chamber pacing and sensing capabilities can be achieved, but the device is prone to infections and Twiddler's syndrome
Solution Approach 1:
The patent removes the external pacemaker can and leads from the system, extracting only the necessary pacing and sensing functions into a leadless intra-cardiac device. This eliminates the infection pathway through leads and skin penetration while maintaining dual-chamber functionality through wireless communication between device components.
Solution Approach 2:
The patent employs a nested structure where the electrode is contained within the sheath during delivery, and the leadless device is implanted within the heart chambers. The sheath protects the electrode during insertion, then retracts to allow the electrode to deploy and anchor independently, creating a compact nested delivery system.
2Reliability
If leadless intra-cardiac devices are used, then infection risk is reduced, but dual-chamber pacing and sensing capabilities are limited
Solution Approach 1:
The patent divides the pacemaker system into separate functional components: a leadless housing with electronics implanted in one chamber, and a separate electrode deployed to another chamber. These segments communicate wirelessly, enabling dual-chamber pacing without requiring physical lead connections, thus maintaining versatility while eliminating infection risks.
Solution Approach 2:
The leadless housing contains universal pacing and sensing circuitry that can function in multiple chambers. The device is designed to provide both atrial and ventricular pacing capabilities through a single implantable unit, with the ability to sense and pace in the chamber where it is implanted, combined with wireless communication to another chamber.
3Adaptability or versatility
If multiple separate leadless devices are used for dual-chamber pacing, then wireless communication power consumption increases
Solution Approach 1:
The patent combines multiple functions into a single leadless housing unit that includes both the pulse generator electronics and the ability to communicate wirelessly. By merging the control electronics and communication transceiver into one device rather than using multiple separate leadless devices, the system reduces total power consumption while maintaining dual-chamber capability.
Data Source
AI summary
A method of implanting a leadless intra-cardiac medical device. An introducer assembly is introduced into one of an inferior vena cava or a superior vena cava of a heart and maneuvered into a first chamber of the heart. A housing is pushed out of a sheath of the introducer toward a first implant location within the first chamber, and the housing is anchored to the first implant location. The sheath is moved away from the anchored housing, and an electrode is urged to a distal end of the sheath due to the pushing, anchoring, and moving. The sheath is maneuvered to a second chamber of the heart, and the electrode is forced into a second implant location with the second chamber. The electrode is anchored to the second implant location. The sheath is moved away from the electrode after the anchoring, and the sheath is removed from the heart.