Reusable Leadless Pacemaker Delivery System with Reset Mechanism
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Solution Overview
Problem
Current leadless pacemaker delivery systems are single-use, requiring multiple systems for multiple implants, leading to increased costs and waste, as they cannot be reused for successive deliveries and implantations.
Innovation Solution
A reusable medical leadless pacemaker delivery system with a reset mechanism that allows the attachment mechanism to transition predictably between engaged and disengaged states, using a tether snare or parallel tethers to secure and release leadless pacemakers, enabling multiple implantations with a single system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-use delivery system is used for each implant, then the attachment and delivery process is simple and reliable, but the cost increases and waste is generated when multiple pacemakers need to be implanted
Solution Approach 1:
The delivery system incorporates a dynamic attachment mechanism with tethers that can transition between engaged and disengaged states. The tethers include retrieval features that allow the system to securely attach the leadless pacemaker during delivery, then reliably release it after implantation. This dynamic capability enables the same system to be reused for multiple implantations without compromising attachment reliability.
Solution Approach 2:
The system is designed to recover and retain the leadless pacemaker during the delivery process, then deliberately discard it at the target site through controlled release. The reset mechanism allows the delivery system to return to its initial state after each implantation, enabling recovery of the system for subsequent uses rather than single-use disposal.
2Reliability
If multiple separate delivery systems are used for multiple pacemaker implants, then each implantation can be performed independently and reliably, but the cost to manufacturer and end user increases significantly
Solution Approach 1:
The delivery system is designed as a universal platform capable of delivering multiple leadless pacemakers through successive implantations. The system includes reusable components such as the catheter shaft, handle, and reset mechanism that can be used across multiple procedures. The attachment mechanism with retrievable tethers provides consistent reliable attachment and release functionality for each implantation using the same system.
Solution Approach 2:
The system employs periodic action through its reset mechanism that returns the attachment mechanism to its initial state after each implantation. This allows the system to perform the attachment-delivery-release cycle repeatedly for multiple pacemakers, reducing the quantity of delivery systems needed while maintaining implantation reliability through consistent periodic operation.
3Loss of substance
If a reusable delivery system is implemented, then costs are reduced and waste is minimized, but the system complexity increases with the need for reset mechanisms and attachment control
Solution Approach 1:
The delivery system is segmented into distinct functional modules: the catheter shaft for navigation, the handle for operator control, the attachment mechanism with tethers for securing the pacemaker, and the reset mechanism for returning to initial state. This segmentation allows the complex reusable system to be managed through modular components, where each segment performs a specific function and can be independently controlled or replaced if needed.
Solution Approach 2:
The tethers with retrieval features serve as intermediaries between the delivery system and the leadless pacemaker. These tethers provide the attachment and release functionality, acting as a mediator that enables the reset mechanism to control the attachment state without requiring direct complex interaction between the handle and pacemaker. This intermediary simplifies the overall system control architecture.
Data Source
AI summary
Disclosed herein is a medical leadless pacemaker delivery system adapted to engage and disengage with leadless pacemakers to allow for the repeated use of the leadless pacemaker delivery system in delivering and implanting multiple leadless pacemakers into a patient heart in a serial or repeated manner. The leadless pacemaker delivery system includes a handle, an attachment mechanism, a torque portion, and a rotation limiter. The handle includes a housing. The attachment mechanism is operably coupled to the housing and configured to actuate between a released state and an engaged state. The torque portion is operably coupled to the housing and rotatable relative to the housing to transition the attachment mechanism between the released and engaged states. The torque portion includes a shaft. The rotation limiter is in sliding engagement with the shaft between a first stop and a second stop. The rotation limiter includes a first helical thread. The leadless pacemaker delivery system also includes a second helical thread in threaded engagement with the first helical thread and operably coupled to the housing. Rotation of the torque portion rotates the rotation limiter such that the first helical thread is rotated against the second helical thread, thereby driving the rotation limiter along the shaft between the first stop and the second stop.