Leadless Intra-Cardiac Device Feed-Thru Reduction

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Solution Overview

Problem

Current leadless implantable medical devices (LIMDs) face limitations due to multiple components within the housing, which increase cost and size, primarily due to the use of multiple feed-thrus for conductors and electrodes, leading to complications such as venous stenosis and device-related infections.

Innovation Solution

A leadless implantable medical device design that reduces the number of feed-thrus by integrating the battery and electronics module within a single housing, using a non-conductive coupler to separate the battery case and end cap electrically while allowing a single feed-thru for both atrial and ventricular pacing and sensing, with an intra-cardiac device extension for remote electrode placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple feed-thrus are used to connect electrodes and conductors in LIMD, then electrical connectivity for pacing and sensing is achieved, but device size and cost increase

Engineering Contradiction:
Improveelectrical connectivityVSAvoiddevice size
Core Design Contradiction:
ReliabilityVSVolume of moving object

Solution Approach 1:

The patent combines multiple electrical connection functions into a single feed-thru structure. The housing serves as a common electrical connection point that integrates the functions of multiple separate feed-thrus, allowing multiple electrodes and conductors to be connected through one unified interface, thereby reducing device size while maintaining electrical connectivity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The housing is designed to perform multiple functions: it serves as both the structural enclosure and as an electrical connection component. By making the housing electrically conductive and using it as a common electrode, the design eliminates the need for separate feed-thru structures for each electrode connection, achieving multi-functionality that reduces overall device complexity and size.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If multiple feed-thrus are used in LIMD housing, then electrical connectivity is maintained, but manufacturing complexity and cost increase

Engineering Contradiction:
Improveelectrical connectivityVSAvoidhousing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple separate feed-thru components into a single integrated housing structure. Instead of having multiple discrete feed-thrus that each require separate manufacturing and assembly, the housing itself is designed to provide all necessary electrical connections, significantly simplifying the manufacturing process and reducing assembly steps.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention extracts the feed-thru function from separate components and integrates it directly into the housing structure. By removing the need for distinct feed-thru elements and incorporating electrical connectivity directly into the housing, the design reduces component count and simplifies the overall device architecture.

Inventive Principle:
Principle #2Taking out (Extraction)

3Adaptability or versatility

If multiple feed-thrus are used for electrode connections, then pacing and sensing functionality is achieved, but risk of venous stenosis and infection increases

Engineering Contradiction:
Improvepacing and sensing functionalityVSAvoidvenous stenosis and infection risk
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the electrical connection function from multiple separate feed-thrus and consolidates it into a single housing-based connection system. This reduction in the number of feed-thrus directly translates to fewer potential sources of infection and less mechanical trauma to surrounding tissues, thereby reducing the risk of venous stenosis and device-related infections while maintaining full pacing and sensing functionality.

Inventive Principle:
Principle #2Taking out (Extraction)

4Device complexity

If battery and end cap are electrically connected, then simplified circuitry is achieved, but loss of electrical isolation between battery components increases

Engineering Contradiction:
Improvecircuitry simplicityVSAvoidelectrical isolation
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent applies local quality by providing electrical insulation only at specific critical interfaces where needed. The non-conductive coupler insulates the battery terminals from the housing at the connection point, while allowing the battery case to be electrically connected to the housing for common electrode functionality. This localized insulation approach maintains circuit simplicity while preserving necessary electrical isolation.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS9265962B2Leadless intra-cardiac medical device with reduced number of feed-thrus
Publication Date: 2016.02.23 PACESETTER INC
  • US9265962B2 patent drawing
  • US9265962B2 patent drawing
  • US9265962B2 patent drawing

AI summary

A leadless implantable medical device (LIMD) includes a housing formed from a battery and an end cap. A proximal end of the end cap forms an LIMD proximal end and a distal end of the battery case forms an LIMD distal end. A non-conductive coupler mechanically secures a terminal end of the battery case to a mating end of the end cap, while maintaining the battery case and end cap electrically separated. A first electrode projects from the proximal end of the end cap. An intra-cardiac (IC) device extension projects from the distal end of the battery case. The extension includes a second electrode that is electrically connected to the battery case. The second electrode is located remote from the LIMD distal end. An electronics module is located within an internal cavity of the end cap and communicates with the first and second electrodes.