Leadless Pacemaker Module with Detachable Fixation Connector

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Solution Overview

Problem

Implantable medical devices, such as leadless cardiac pacemakers, often face challenges in removal due to tissue overgrowth, making it difficult to replace them when the power source reaches the end of its life, as the fixation portion becomes entangled or captured by significant tissue growth.

Innovation Solution

The design incorporates a releasable connector system between the device module and the fixation module, allowing for secure attachment and detachment, with features like fluoroscopic markers for alignment, locking tabs and slots, and a silicone spring seal for secure engagement, enabling easy removal and replacement of the device module while leaving the fixation module in place.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the fixation portion is designed to be permanently fixed to the heart, then the device provides stable long-term anchoring, but the device cannot be removed or replaced when the power source reaches end of life

Engineering Contradiction:

Improvestable anchoringVSAvoidremovability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The device is divided into two separable modules: a fixation portion that remains anchored to the heart and a device portion containing the power source that can be removed and replaced. The fixation portion includes fixation elements (tines or helix) that provide stable anchoring, while the device portion houses the battery and electronics. A releasable connector with locking tabs and slots maintains secure connection during operation but allows intentional separation when replacement is needed.

Inventive Principle:

Principle #1Segmentation

2Device complexity

If the device module is made as a single integrated unit, then the structure is simple and robust, but the device cannot be easily removed due to tissue overgrowth

Engineering Contradiction:

Improvestructural simplicityVSAvoidease of removal

Core Design Contradiction:

Device complexityVSEase of operation

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

3Strength

If the fixation elements are designed to strongly anchor the device, then the device remains securely positioned, but the fixation portion becomes difficult to remove due to tissue overgrowth

Engineering Contradiction:

Improveanchoring strengthVSAvoidease of removal

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device portion containing the power source and electronics is extracted as a separate removable module from the fixation portion. This allows the fixation elements to remain strongly anchored in the heart tissue while the device portion can be easily detached and replaced without removing the fixation elements.

Inventive Principle:

Principle #2Taking out (Extraction)

4Ease of operation

If the device is designed for easy removal, then replacement is simple, but the device may not remain securely anchored during normal operation

Engineering Contradiction:

Improveease of replacementVSAvoidsecure anchoring

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Data Source

PatentEP3573708B1Leadless implantable device with detachable fixation

Publication Date: 2021.03.10 CARDIAC PACEMAKERS INC

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AI summary

An implantable medical device (IMD) may include a fixation module, and a device module that is configured to be releasably connected to the fixation module. The device module may have a proximal end and a distal end, and may include a power source and a controller that is operably coupled to the power source. The controller may be configured to sense cardiac electrical activity via two or more electrodes and/or deliver pacing pulses via two or more electrodes. The device module may include a first part of a releasable connector while the fixation module may include a second part of the releasable connector, wherein the first part of the releasable connector and the second part of the releasable connector cooperate to releasably connect the device module with the fixation module.