Active-Fixation Lead Deployment for Near-Heart Anchoring

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Solution Overview

Problem

Existing implantable medical leads face challenges in securely positioning electrodes close to the heart, leading to increased energy requirements for therapy delivery, reduced longevity of devices, and inconsistent therapy due to distance from the heart, especially when electrodes are distributed along the lead's length.

Innovation Solution

A delivery system with a sheath having apertures and structural weaknesses allows fixation mechanisms to anchor the lead near the heart, ensuring proximity and secure implantation by deploying through the sheath apertures and tearing along structural weaknesses for removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fixation mechanisms are deployed to anchor the lead near the heart, then therapy consistency and device longevity are improved, but device complexity increases

Engineering Contradiction:

Improvetherapy consistencyVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The fixation mechanisms are nested within the delivery sheath during implantation. The sheath provides a protective pathway that contains the fixation elements until they reach the target location, at which point the fixation mechanisms are deployed from the sheath to anchor the lead near the heart, ensuring therapy consistency while managing device complexity through staged deployment

Inventive Principle:

Principle #7Nested doll (Nesting)

2Duration of action of stationary object

If fixation mechanisms are deployed to anchor the lead near the heart, then device longevity is improved, but device complexity increases

Engineering Contradiction:

Improvedevice longevityVSAvoiddevice complexity

Core Design Contradiction:

Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

Inventive Principle:

Principle #7Nested doll (Nesting)

3Use of energy by moving object

If electrodes are positioned closer to the heart, then energy requirements for therapy are reduced, but procedural safety risks increase

Engineering Contradiction:

Improveenergy requirementsVSAvoidprocedural safety risks

Core Design Contradiction:

Use of energy by moving objectVSObject-affected harmful factors

Solution Approach 1:

The delivery sheath is advanced to the target location near the heart before the lead and fixation mechanisms are deployed. This preliminary positioning allows the operator to establish the correct anatomical location and orientation before committing the lead to position, enabling safer placement closer to the heart while minimizing procedural risks through pre-positioning and controlled deployment

Inventive Principle:

Principle #10Preliminary action

4Reliability

If electrodes are positioned closer to the heart, then therapy consistency is improved, but procedural safety risks increase

Engineering Contradiction:

Improvetherapy consistencyVSAvoidprocedural safety risks

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20250242162A1Delivery system for active-fixation lead deployment

Publication Date: 2025.07.31 MEDTRONIC INC

AI summary

In some examples, a system includes a sheath including an elongated shaft defining a lumen. The sheath also includes a distal portion with one or more apertures in the shaft, and an implantable medical lead configured to be delivered through the sheath to an implant site in a patient. The lead includes one or more fixation mechanisms, wherein the one or more fixation mechanisms, when deployed, are configured to extend through the one or more apertures in the sheath and engage with patient tissue at the implant site.