Transappendage Cardiac Lead Placement for Stroke Prevention

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Solution Overview

Problem

Current methods for preventing stroke in atrial fibrillation patients, such as oral anticoagulants and surgical removal of the left atrial appendage, have limitations including side effects, invasive procedures, and risks of thrombosis due to foreign devices or incomplete ligation.

Innovation Solution

A method and system for placing an electrical lead into the heart that secures a tool to the atrial appendage, pierces it to create an aperture, and inserts the lead into the ventricle, while using an abutment member to prevent direct contact and potentially inhibit thrombosis, along with a minimally invasive approach to occlude the left atrial appendage using a ring or clip applicator.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If an electrical lead is placed through the left atrial appendage, then access to the left side of the heart is achieved, but the risk of thrombosis formation increases due to foreign device presence

Engineering Contradiction:
Improveaccess to left side of heartVSAvoidthrombosis risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the electrical lead from the traditional transvenous pathway and routes it through the left atrial appendage, removing it from the harmful environment of the venous system and positioning it in a more favorable anatomical location that reduces thrombosis risk while maintaining electrical functionality

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an intermediary device or method that facilitates lead placement through the left atrial appendage while minimizing direct contact between the lead and thrombogenic surfaces, thereby reducing the harmful thrombosis effect while maintaining the beneficial access capability

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the left atrial appendage is removed via open chest surgery, then stroke prevention is achieved, but patient trauma and bleeding increase

Engineering Contradiction:
Improvestroke preventionVSAvoidpatient trauma and bleeding
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-chest surgical approach with a less invasive method, substituting the traumatic physical removal procedure with an alternative technique that achieves the same stroke prevention outcome while minimizing patient trauma and bleeding through non-surgical or minimally invasive means

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If the left atrial appendage is occluded with a barrier device, then clot formation is prevented, but the risk of thrombosis on the foreign device increases

Engineering Contradiction:
Improveclot formation preventionVSAvoiddevice-related thrombosis
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts or removes the foreign barrier device from the left atrial appendage after it has served its purpose of preventing clot formation during the initial healing phase, thereby maintaining the beneficial clot prevention outcome while eliminating the ongoing harmful effect of device-related thrombosis risk

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs a temporary occlusion device that is discarded after serving its protective function, allowing the native tissue to heal and assume the protective role permanently, thus achieving sustained clot prevention without the long-term thrombosis risk associated with permanent foreign devices

Inventive Principle:
Principle #34Discarding and recovering

Data Source

PatentUS9656063B2Method and system for placement of electrical lead inside heart
Publication Date: 2017.05.23 MEDTRONIC INC
  • US9656063B2 patent drawing
  • US9656063B2 patent drawing
  • US9656063B2 patent drawing

AI summary

A method of placing an electrical lead of an implantable cardiac device inside a heart of a patient. The method includes securing a tool to an atrial appendage of the heart to hold onto the atrial appendage, piercing the atrial appendage, and creating an aperture in the atrial appendage while holding the atrial appendage with the tool. The method also includes moving a distal end of the electrical lead into the heart through the aperture in the atrial appendage and into a ventricle of the heart. Furthermore, the method includes coupling the distal end of the electrical lead to cardiac tissue in the ventricle and delivering an electrical signal to the cardiac tissue in the ventricle of the heart to maintain a predetermined heartbeat of the heart.