Compact Dual-Chamber Pacing Device With Integrated Leadlet
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
There is a need for improved interventional medical systems that facilitate the implantation of relatively compact intra-cardiac dual chamber pacing devices, addressing mechanical complications and MRI compatibility issues associated with traditional elongate lead wires.
Innovation Solution
An implantable medical device with a ventricular portion and an atrial portion, featuring a hermetically sealed housing, an electrode, and elastically deformable fixation tines, along with a flexible leadlet that connects the two portions, allowing for secure tissue contact and deployment using a delivery tool.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional elongate lead wires are used to connect pacemaker to electrodes, then electrical connection is achieved, but mechanical complications and MRI compatibility issues occur
Solution Approach 1:
The patent removes the traditional elongate lead wires from the system and replaces them with a hermetically sealed compact package containing all necessary components (pulse generator, electrodes, and short leadlets). This extraction eliminates the source of mechanical complications and MRI incompatibility while preserving electrical connection functionality through integrated leadlets that are shorter and more robust.
Solution Approach 2:
The patent combines the pulse generator, electrodes, and leadlets into a single hermetically sealed compact package. This merging eliminates the need for separate lead wire connections, reducing mechanical failure points and improving MRI compatibility while maintaining reliable electrical connection between the pacemaker and cardiac tissue.
2Object-affected harmful factors
If compact intra-cardiac device is implanted, then mechanical complications and MRI compatibility are improved, but device complexity increases
Solution Approach 1:
The patent employs a nested structure where the leadlet is folded over on itself and received within an open channel formed along the core of the atrial portion. This nesting allows the compact device to accommodate the necessary electrical connections within a small footprint, managing complexity through spatial organization rather than increasing overall device size.
Solution Approach 2:
The device is divided into distinct functional segments: ventricular portion with electrode, atrial portion with core and open channel, and leadlet connecting them. This segmentation allows each component to be optimized independently while maintaining overall compactness, managing complexity through modular design within the hermetically sealed package.
3Volume of moving object
If leadlet is folded over on itself and received in open channel, then device compactness is achieved, but leadlet accessibility for implantation becomes challenging
Solution Approach 1:
The leadlet is pre-folded and pre-positioned within the open channel of the atrial portion during manufacturing. This preliminary action ensures that during implantation, the leadlet is already in its final compact configuration, eliminating the need for complex intra-procedural folding or manipulation and simplifying the implantation process despite the compact design.
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
The solution enables secure and efficient implantation of the dual chamber pacing device without perforating the visceral pericardium, ensuring effective pacing and sensing while minimizing mechanical complications and MRI incompatibility issues.
Implementation Method 1
a plurality of elastically deformable fixation tines form a fixation mechanism of the atrial portion
Implementation Method 2
a proximal, spring portion being fixedly attached to the atrial portion core and having a spring-biased pre-formed curvature
Data Source
Figure 1
Figure 2A
Figure 2B
AI summary
An implantable medical device includes ventricular and atrial portions, and a flexible leadlet that extends therebetween. An open channel of the atrial portion, formed along a core thereof, is sized to receive the leadlet therein, when the leadlet is folded over on itself. An interventional medical system includes the device and a delivery tool; a tubular sidewall of the tool defines a lumen and has a tether extending therein. A slot formed in the sidewall extends proximally from an open end thereof, coincident with a distal opening of the lumen. When the atrial portion is contained within the lumen, a segment of the leadlet extends alongside the atrial portion; another segment of the leadlet, being folded over on itself, proximal to the atrial portion, has the tether engaged therewith. The slot may allow passage of the leadlet therethrough, when the atrial portion is positioned for deployment through the distal opening.