Modular Electrode Assembly for Epicardial Stimulation

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Solution Overview

Problem

Ambulatory medical devices face challenges in consistently stimulating cardiac tissue due to elevated capture thresholds caused by fibrous tissue growth and trauma, leading to increased energy consumption and reduced device longevity, especially in epicardial stimulation where proper lead and electrode placement is uncertain, and vulnerable tissues like coronary arteries or nerves may be damaged.

Innovation Solution

A modular electrostimulation electrode assembly with a fixation support member and an electrostimulation electrode that can be securely attached and detached, allowing for precise placement and reduced trauma, featuring a centrally located open portal for visualization and tissue ingrowth promotion, and an untethered electrostimulation device for chronic stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrodes are affixed to cardiac tissue for chronic stimulation, then therapeutic effect is achieved, but tissue trauma and fibrous tissue growth occur causing elevated capture threshold

Engineering Contradiction:

Improvecapture threshold consistencyVSAvoidtissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into separate modules: a fixation support member that remains affixed to the heart and an electrostimulation electrode module that can be detached and replaced. This segmentation allows the fixation element to stay in place (avoiding repeated trauma) while the electrode module can be exchanged if needed.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The electrostimulation electrode is extracted as a separate, removable module from the fixation support member. This allows the electrode to be taken out and replaced independently without removing the entire fixation assembly, reducing trauma associated with complete removal and reattachment.

Inventive Principle:

Principle #2Taking out (Extraction)

2Reliability

If device output energy is increased to compensate for elevated capture threshold, then stimulation reliability is improved, but battery power consumption increases reducing device longevity

Engineering Contradiction:

Improvestimulation reliabilityVSAvoidbattery power consumption

Core Design Contradiction:

ReliabilityVSUse of energy by moving object

Solution Approach 1:

The fixation support member is affixed to the heart in advance and remains in place, establishing a stable baseline position. This preliminary action ensures consistent electrode-to-tissue contact, maintaining reliable capture thresholds without requiring increased energy output.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If lead and electrode replacement is performed due to fracture or malfunction, then device functionality is restored, but trauma to patient increases

Engineering Contradiction:

Improvedevice functionalityVSAvoidpatient trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is segmented into a permanent fixation support member and a replaceable electrode module. When replacement is needed, only the electrode module is detached and replaced, leaving the fixation support member in place. This minimizes surgical trauma compared to removing and reattaching the entire assembly.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The electrode module is extracted as a separate replaceable component. This allows malfunctioning electrodes to be replaced without disturbing the fixation support member, reducing the scope of surgical intervention and associated patient trauma.

Inventive Principle:

Principle #2Taking out (Extraction)

4Ease of operation

If epicardial stimulation is used for patients with compromised venous system, then stimulation is achieved, but uncertainty in proper lead and electrode placement occurs

Engineering Contradiction:

Improvepatient eligibilityVSAvoidplacement accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The fixation support member is designed to self-align and self-secure to the epicardial surface through its geometric features (flat surface, peripheral flange, engagement protrusions). This self-service mechanism eliminates the need for complex placement procedures or precise manual positioning, ensuring accurate and reproducible placement while expanding eligibility to patients with compromised venous systems.

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS9694172B2Implantable medical devices with separate fixation mechanism

Publication Date: 2017.07.04 CARDIAC PACEMAKERS INC

AI summary

Devices or methods such as for stimulating excitable tissue or sensing physiologic response or other signals that can use separate fixation mechanism is described. An implantable apparatus can include a modular electrostimulation electrode assembly that can include a first module and a second module that can be end user-attachable to each other and end user-detached from each other. The first module can include an electrostimulation electrode fixation support member that can be laid flat against or otherwise conform to a surface of a heart, and can define a centrally located open portal such as for permitting electrode access to the surface of the heart. The second module can include an electrostimulation electrode that can be inserted through the portal of the fixation support member such as to contact the surface of the heart such as to deliver chronic electrostimulation to the heart.