Torque Limiter for Leadless Medical Device Anchoring

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Solution Overview

Problem

Existing implantable medical devices face challenges in securely anchoring to heart tissue without causing tissue damage, particularly in thin walls like the atrial septum or apical region of the right ventricle, and require a safe and effective method for implantation, removal, and repositioning, while minimizing the risk of migration and ensuring quick procedure times.

Innovation Solution

A delivery system with a torque limiter mechanism that limits radial torque transmission to prevent excessive rotation and potential tissue damage, using a catheter with a handle and torque shaft coupled to a torque limiter at the distal end, which secures the leadless capsule to the heart wall without further rotation after anchoring, employing a deformable elastic component like a helical spring for radial compression and secure attachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a helical screw anchoring mechanism is used to securely anchor the medical device to heart tissue, then the anchoring strength is improved, but the risk of tissue damage increases

Engineering Contradiction:

Improveanchoring strengthVSAvoidtissue damage

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by modifying the torque transmission characteristics through a torque limiter mechanism. The torque limiter changes the torque parameter from uncontrolled to controlled, allowing sufficient torque for anchoring while preventing excessive torque that would cause tissue damage. This resolves the contradiction by adjusting the torque parameter to an optimal range that achieves both secure anchoring and tissue protection.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The torque limiter acts as an intermediary component between the delivery system and the anchoring mechanism. It mediates the torque transmission, allowing controlled torque transfer during anchoring while blocking excessive torque that would cause tissue damage. This intermediary mechanism enables both strong anchoring and tissue protection simultaneously.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If the delivery system allows continuous rotation during implantation, then the implantation speed is improved, but the risk of excessive rotation and tissue damage increases

Engineering Contradiction:

Improveimplantation speedVSAvoidexcessive rotation

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The torque limiter serves as an intermediary that allows continuous rotation during implantation while automatically limiting the torque transmitted to the anchoring mechanism. This enables the operator to rotate the delivery system continuously for efficient implantation without risking excessive rotation, as the torque limiter blocks any torque beyond the safe threshold.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The torque limiter implements preliminary anti-action by pre-establishing a torque threshold that prevents excessive rotation before it can occur. The mechanism is designed to automatically resist and block any torque exceeding the predetermined limit, thereby preventing harmful excessive rotation while allowing safe continuous rotation for efficient implantation.

Inventive Principle:

Principle #9Preliminary anti-action

3Reliability

If a secure coupling between the delivery system and medical device is used, then the reliability of delivery is improved, but the ease of release decreases

Engineering Contradiction:

Improvedelivery reliabilityVSAvoidrelease ease

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The coupling mechanism employs dynamic characteristics with a torque limiter that provides different torque transmission characteristics in different operational phases. During delivery, the coupling is secure with high torque transmission. During release, the mechanism becomes easier to disengage through a different torque regime, allowing the delivery system to be rotated in the opposite direction to overcome the coupling and achieve release.

Inventive Principle:

Principle #15Dynamics

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The torque limiter system effectively prevents tissue damage by limiting radial torque after anchoring, ensuring secure fixation and safe operation, allowing for quick and efficient implantation and potential repositioning of the leadless capsule, while maintaining the integrity of the heart tissue.

Implementation Method 1

employing a deformable elastic component like a helical spring for radial compression and secure attachment

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

employing a deformable elastic component like a helical spring for radial compression and secure attachment

Methodology Applied

Scientific EffectRadial compression: Compression

Data Source

PatentUS12151115B2Torque limiting mechanism between a medical device and its implantation accessory

Publication Date: 2024.11.26 SORIN CRM

AI summary

A torque limiter for a delivery system of a leadless active implantable medical device includes a first interface for coupling to a docking feature of the delivery system, the docking feature secured in rotation with respect to the leadless active implantable medical device and a second interface for coupling to a distal end of a torque shaft of the delivery system, the torque limiter limiting the torque transmission from the torque shaft to the docking feature when radial torque is applied to the torque shaft.