Heart Valve Prosthesis Predefined Passage for Pacemaker Lead

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Solution Overview

Problem

The implantation of a replacement heart valve prosthesis in patients with pre-existing pacemakers often results in paravalvular leakage due to the pacemaker lead being positioned between the natural heart valve wall and the replacement heart valve, leading to exclusion of such patients from receiving lifesaving treatment.

Innovation Solution

A replacement heart valve prosthesis with predefined passages, such as lead gateways, that allow for the secure passage of accessory means like pacemaker leads without interfering with the sealing function, using sealing materials and hemostatic valves to prevent leakage and maintain the prosthesis's functionality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a replacement heart valve prosthesis is implanted in a patient with a pre-existing pacemaker lead, then the patient receives lifesaving heart valve replacement treatment, but paravalvular leakage occurs due to the pacemaker lead being positioned between the natural heart valve wall and the replacement prosthesis

Engineering Contradiction:

Improvesealing functionVSAvoidcompatibility with pre-existing pacemaker

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The sealing element is segmented to include a predefined passage that accommodates the pacemaker lead. The sealing element is divided into regions: a first region for sealing against the natural valve annulus, a second region forming the predefined passage for the lead, and a third region for sealing against the prosthesis frame. This segmentation allows the sealing element to simultaneously seal around the lead and maintain the sealing function.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The predefined passage acts as an intermediary structure that mediates between the sealing requirement and the pacemaker lead presence. The passage provides a dedicated pathway for the lead through the sealing element, allowing the lead to pass through without creating paravalvular leakage. The passage may include hemostatic valves or sealing mechanisms that close around the lead to prevent leakage.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Adaptability or versatility

If the pacemaker lead is positioned between the natural heart valve wall and the replacement heart valve prosthesis, then the pacemaker can remain implanted, but paravalvular leakage occurs in the area of the pacemaker lead

Engineering Contradiction:

Improvepacemaker lead positioningVSAvoidparavalvular leakage

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The predefined passage is prepared in advance during prosthesis manufacturing, creating a predetermined pathway for the pacemaker lead. This preliminary action ensures that when the prosthesis is implanted, the lead can be positioned through the pre-formed passage without causing leakage. The passage may include pre-positioned hemostatic valves or sealing structures that are ready to seal around the lead.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The sealing element has different local qualities: a first sealing region for sealing against the natural valve annulus, a passage region for accommodating the lead, and a second sealing region for sealing against the prosthesis frame. Each region is optimized for its specific function, with the passage region allowing lead passage while the sealing regions prevent leakage.

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If a predefined passage is incorporated into the sealing material for accessory means passage, then patients with pre-existing pacemakers can receive heart valve replacement without paravalvular leakage, but the prosthesis structure becomes more complex

Engineering Contradiction:

Improvecompatibility with pacemaker and accessoriesVSAvoidprosthesis structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The predefined passage is designed to be universal, accommodating various types of accessory means including pacemaker leads, defibrillator leads, and other catheters. The passage structure and hemostatic valves are configured to seal around different sized and shaped accessories, making the prosthesis compatible with multiple device types without requiring separate designs for each accessory.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentEP4287991B1Replacement heart valve prosthesis with a predefined passage

Publication Date: 2026.04.01 TRICARES SAS

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AI summary

The present disclosure concerns a replacement heart valve prosthesis with a predefined passage, a system comprising same and a method for implantation of said system and a method for introducing an accessory means through the predefined passage of a replacement heart valve prosthesis or a method for implanting a pacemaker lead or electrode or any other cable into a heart.