Suture Sleeve Lead Stabilizer for Implantable Medical Devices

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Solution Overview

Problem

Existing implantable medical leads require secure anchoring methods to ensure proper positioning and stability during implantation, as current methods can be inefficient and require manual placement by medical professionals, potentially leading to inaccuracies.

Innovation Solution

A suture sleeve with an interior lumen and exterior suture receiving tracks, combined with engagement features like radial projections or adhesive layers, is designed to non-removeably secure the sleeve to the implantable lead, allowing for pre-assembly during manufacturing and facilitating efficient implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If manual placement methods are used during implantation, then flexibility in positioning is maintained, but implantation efficiency decreases and inaccuracies may occur

Engineering Contradiction:

Improveimplantation efficiencyVSAvoidmanual placement requirement

Core Design Contradiction:

ProductivityVSEase of operation

Solution Approach 1:

The suture sleeve is pre-assembled and non-removeably secured to the implantable lead during manufacturing, creating a pre-configured assembly that eliminates the need for manual placement during implantation surgery, thereby improving efficiency while maintaining positioning accuracy

Inventive Principle:

Principle #10Preliminary action

2Reliability

If removable attachment methods are used, then adjustability during implantation is maintained, but anchoring stability decreases

Engineering Contradiction:

Improveanchoring stabilityVSAvoidadjustability during implantation

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The mechanical removable attachment system is replaced with a non-removeable engagement feature that provides permanent anchoring stability, ensuring reliable fixation of the suture sleeve to the lead while maintaining the necessary positioning capabilities through precise manufacturing tolerances

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If complex engagement features are used to secure the suture sleeve, then anchoring reliability improves, but device complexity increases

Engineering Contradiction:

Improvesuture sleeve anchoringVSAvoidengagement feature structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Rather than making the entire suture sleeve complex, the patent applies a localized engagement feature at a specific position on the lead, providing the necessary anchoring reliability only where needed while keeping the rest of the device simple and maintainable

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS10286208B2Fully integrated lead stabilizer for medical electrical leads and methods of attachment

Publication Date: 2019.05.14 CARDIAC PACEMAKERS INC

AI summary

Various aspects of the present disclosure are directed toward methods, apparatuses, and systems that include an implantable medical device comprising an implantable lead, a suture sleeve having an interior surface defining a lumen of the suture sleeve that receives the implantable lead, and an engagement feature configured to non-removeably secure the suture sleeve to the implantable lead.