Leadless Pacemaker Delivery Tool with Grasping Mechanism
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Solution Overview
Problem
Traditional implantable cardiac pacemakers face mechanical complications and MRI compatibility issues due to elongate lead wires, prompting the need for compact devices that can be deployed closer to the pacing site with efficient deployment and fixation tools.
Innovation Solution
Development of delivery tools that contain the entire compact implantable medical device, with a grasping mechanism to deploy and secure the device at the target site, and conductive features for evaluating sensing functions without withdrawing the tool, allowing for precise placement and testing of fixation members within the venous system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If traditional implantable cardiac pacemakers with elongate lead wires are used, then the device can be implanted remotely from the heart, but mechanical complications and MRI compatibility issues occur
Solution Approach 1:
The invention extracts and removes the elongate lead wires from the traditional pacemaker system, eliminating the source of mechanical complications and MRI incompatibility. The pacemaker device is reconfigured to be leadless, with electrodes integrated directly into the device housing, allowing implantation without long lead wires extending to the heart.
Solution Approach 2:
The compact leadless pacemaker device is designed to be contained within a delivery catheter during implantation. The device nests within the catheter structure, which provides a confined space that protects the device during navigation through the venous system to the heart, enabling precise placement without requiring long lead wires.
2Reliability
If compact implantable devices are deployed closer to the pacing site, then mechanical complications and MRI issues are reduced, but efficient deployment and fixation tools are required
Solution Approach 1:
The delivery system combines multiple functions into an integrated tool: the delivery catheter simultaneously provides navigation, device containment, and fixation capabilities. The fixation member is integrated into the delivery tool, allowing deployment and securing of the pacemaker device in a single coordinated action, reducing the need for separate complex tools.
Solution Approach 2:
The delivery tool is designed as a multi-functional device that can navigate the venous system, contain the compact pacemaker, deploy the fixation member, and secure the device at the pacing site. This universal tool eliminates the need for multiple separate instruments, simplifying the overall procedure despite the compact device size.
3Manufacturing precision
If the entire device is contained within the delivery tool, then precise placement is enabled, but the tool must be navigated through the venous system to the target site
Solution Approach 1:
The compact pacemaker device is nested within the delivery catheter, which itself is navigable through the venous system. This nested configuration allows the entire device to be contained within a relatively short delivery tool that can be advanced through the body's natural vasculature to the precise implantation site near the heart.
Solution Approach 2:
The delivery tool incorporates flexible and articulating sections that allow it to dynamically navigate the tortuous path of the venous system. The tool can bend and articulate to follow the anatomical pathways, enabling precise delivery of the compact device to the target site while maintaining a manageable overall length.
4Strength
If fixation member is deployed at the target site, then secure fixation is achieved, but the grasping mechanism must apply tug force to test holding force
Solution Approach 1:
The delivery tool incorporates a grasping mechanism that maintains contact with the pacemaker device after fixation member deployment. This allows real-time feedback through the operator, enabling testing of the fixation holding force by applying gentle tug forces. The operator can feel the resistance and determine whether the fixation is secure or needs adjustment.
Solution Approach 2:
The fixation member is deployed in advance while the device remains contained within the delivery tool. This preliminary fixation allows the operator to test the holding force before fully releasing the device, ensuring secure attachment to the pacing site before completing the implantation procedure.
Data Source
AI summary
Delivery tools of interventional medical systems facilitate deployment of relatively compact implantable medical devices that include extensions, for example, cardiac pacing devices that include an extension for atrial sensing, wherein an entirety of the device is contained within the delivery tool while a distal-most portion of the tool is navigated to a target implant site. Once at the implant site, a device fixation member may be exposed out from a distal opening of the tool, for initial deployment, while the extension remains contained within the delivery tool. The tool includes a grasping mechanism, operable, within and without a lumen of the tool, to alternately grip and release the device extension, for example, to position a distal end of the extension after the tool has been withdrawn from over an entirety of the initially deployed device.