Subcutaneous Lead Anchoring Device for Minimally Invasive Implantation

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Solution Overview

Problem

The existing subcutaneous implantable cardiac defibrillator systems require multiple incisions for anchoring the lead, which can lead to complications such as infection and inappropriate shocks, and there is a need for a more efficient anchoring mechanism that reduces the number of incisions while avoiding interference with sensing electrodes.

Innovation Solution

An anchoring device with flexible arms and a snap-fit or suture attachment feature is designed for the distal tip of the subcutaneous lead, allowing secure anchoring without covering the sensing electrode, and can be introduced through a collapsed configuration for easier implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple incisions are used for anchoring the lead, then secure anchoring is achieved, but the risk of infection and inappropriate shocks increases

Engineering Contradiction:

Improvesecure anchoringVSAvoidinfection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The anchoring device is divided into multiple arms that can be independently deployed to engage with tissue at different locations, providing secure anchoring through distributed attachment points rather than requiring multiple separate incisions

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The anchoring device acts as an intermediary element between the lead and the tissue, providing a secure connection while minimizing direct tissue disruption and reducing infection risk compared to multiple incisions

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If multiple incisions are used for anchoring the lead, then secure anchoring is achieved, but the number of visible scars increases

Engineering Contradiction:

Improvesecure anchoringVSAvoidvisible scars

Core Design Contradiction:

ReliabilityVSShape

Solution Approach 1:

The anchoring device uses multiple arms that can be deployed from a single access point, distributing the anchoring function across multiple tissue engagement points while maintaining a single external incision, thereby reducing visible scarring

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The anchoring device transitions from a two-dimensional planar structure to a three-dimensional deployed configuration, allowing multiple anchoring arms to engage tissue at different spatial locations while accessing through a single incision site

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Ease of manufacture

If the anchoring mechanism covers the sensing electrode, then anchoring is facilitated, but sensing is interfered with

Engineering Contradiction:

Improveanchoring facilitationVSAvoidsensing accuracy

Core Design Contradiction:

Ease of manufactureVSMeasurement precision

Solution Approach 1:

The anchoring device is designed with differentiated regions where the arms are configured to engage tissue without contacting or covering the sensing electrode, ensuring that anchoring and sensing functions occur in spatially separated zones

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The anchoring arms are asymmetrically positioned and oriented to provide effective tissue engagement while maintaining clear separation from the sensing electrode, allowing each component to perform its function without interference

Inventive Principle:

Principle #4Asymmetry

4Reliability

If a rigid anchoring device is used, then stable anchoring is achieved, but implantation difficulty increases

Engineering Contradiction:

Improvestable anchoringVSAvoidimplantation ease

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The anchoring device incorporates flexible arms that can be compressed into a compact configuration for easy implantation through small incisions, then expand to a stable deployed configuration to provide reliable anchoring, transitioning from a low-profile to a high-stability state

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The anchoring arms are constructed from flexible materials that allow the device to be collapsed into a small profile for implantation, then recover their shape to provide stable anchoring, combining ease of insertion with reliable fixation

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS11253696B2Fixation device for a subcutaneous electrode

Publication Date: 2022.02.22 CARDIAC PACEMAKERS INC

AI summary

An illustrative anchoring mechanism is provided for attachment to an implantable subcutaneous lead to facilitate anchoring at the distal tip of the lead. The anchoring mechanism is attached to an opening in a distal portion of a subcutaneous lead prior to implantation. The anchoring mechanism may be designed to avoid covering the sensing electrode of the subcutaneous lead, to prevent interference with sensing. Use of such an apparatus may reduce the number of incisions needed to perform implantation.