Compact Implantable Pacemaker Delivery Tool for In-Situ Sensing
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Solution Overview
Problem
Traditional implantable cardiac pacemakers with elongate lead wires face mechanical complications and MRI compatibility issues, prompting the need for compact devices that can be deployed closer to the pacing site with efficient sensing and fixation capabilities.
Innovation Solution
A delivery tool system that contains the entire compact implantable medical device, featuring a handle, elongate inner member, and deployment tube with conductive features for creating a pathway between the sense electrode and the outside environment, allowing for initial deployment and evaluation without withdrawing the tool, enabling secure fixation and effective pacing and sensing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
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 patent extracts and eliminates the elongate lead wires from the traditional pacemaker system, removing the source of mechanical complications and MRI incompatibility. The device is reconfigured to be wholly contained within a compact housing with electrodes positioned at the pacing site without requiring separate lead wires to extend to remote implant locations.
Solution Approach 2:
The entire pacemaker device including electrodes is nested within a compact housing structure that can be implanted in close proximity to the pacing site. The delivery system employs nested catheters and sheaths that guide the compact device through vasculature to the implant location, with the device itself being a nested integration of electronic components within the housing.
2Ease of operation
If the delivery tool is withdrawn from over the device to evaluate sensing, then the sensing extension can be accessed, but the tool must be removed from the implant site
Solution Approach 1:
The delivery system is configured with a retractable inner catheter that can be preliminarily positioned to expose the sensing extension for evaluation while the outer sheath remains in place at the implant site. This preliminary action allows sensing evaluation to be performed without requiring complete withdrawal of the delivery system, saving time and maintaining device positioning.
Solution Approach 2:
The delivery system employs dynamic, movable components including a retractable inner catheter that can be advanced and retracted relative to the outer sheath. This dynamic configuration allows the operator to expose or cover the sensing extension as needed for evaluation or protection, providing flexible access without tool withdrawal.
3Reliability
If the sensing extension is covered by the delivery tool during navigation, then the device is protected, but sensing evaluation requires tool withdrawal
Solution Approach 1:
The delivery system is segmented into distinct functional components: an outer sheath for navigation and protection, an inner retractable catheter for selective exposure of the sensing extension, and the implanted device itself. This segmentation allows each component to perform its specific function independently, providing protection during delivery while enabling controlled access for evaluation without requiring complete system withdrawal.
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
Enables the deployment and evaluation of compact implantable medical devices with enhanced sensing capabilities, ensuring secure fixation and effective pacing without the need for tool withdrawal, addressing mechanical and MRI compatibility challenges.
Implementation Method 1
an inner conductive feature, which is formed in the inner member, in proximity to the distal end thereof, and an outer conductive feature, which is formed in the deployment tube... the inner conductive feature is configured to provide a conductive pathway between the sense electrode of the aforementioned sensing extension of the device and the outer conductive feature, and the outer conductive feature is configured to provide a conductive pathway between the inner conductive feature and a location outside the deployment tube
Implementation Method 2
wherein a saline flush through the lumen of the inner member and through the apertures can create the conductive pathway
Data Source
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AI summary
Delivery tools of interventional medical systems facilitate deployment of relatively compact implantable medical devices that include sensing extensions, for example, right ventricular cardiac pacing devices that include a sensing extension for atrial sensing. An entirety of such a device is contained within a delivery tool while a distal-most portion of the tool is navigated to a target implant site; the tool is configured to expose, out from a distal opening thereof, a distal portion of the device for initial deployment, after which sensing, via a sense electrode of the aforementioned sensing extension of the device, can be evaluated without withdrawing the tool from over the remainder of the device that includes the sensing extension.