Implantable Lead Connection with Vent Hole for Pressure Relief

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Solution Overview

Problem

Existing implantable lead connections face challenges in achieving a sealed and secure connection between a lead terminal and a lead channel without increasing the complexity of the surgical procedure, as they often result in pressurization issues and potential leakage due to trapped air, which can lead to dislodgment or electrical feedback, especially in devices requiring high fidelity signal processing.

Innovation Solution

A lead connection design featuring a vent hole located on the distal side of the sealing gasket allows for air to escape during initial insertion, reducing internal pressure and eliminating the need for additional venting or securing mechanisms, enabling a secure and sealed connection with a single pushing step.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a sealing gasket is used to create a sealed connection between lead terminal and lead channel, then fluid leakage is prevented, but air becomes trapped and causes pressurization that may dislodge the lead terminal

Engineering Contradiction:

Improveseal integrityVSAvoidpressurization effect

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The lead channel is segmented into two regions by the vent hole: a vented region allowing air escape during insertion and a sealed region maintaining fluid barrier integrity. This segmentation enables simultaneous achievement of sealing and pressure relief.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The vent hole acts as an intermediary pathway that temporarily allows air to escape during the insertion process, mediating between the sealing requirement and the pressure buildup problem. After insertion, the vent hole's position ensures it does not compromise the seal.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If additional venting mechanisms are added to relieve pressurization, then lead terminal dislodgment is prevented, but device complexity and surgical procedure complexity increase

Engineering Contradiction:

Improveconnection securityVSAvoidventing mechanism complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The venting function is merged into the lead channel structure itself through the vent hole, eliminating the need for separate venting mechanisms. The seal and vent are integrated into a single unified structure, reducing device complexity while maintaining reliability.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The lead connection structure provides its own venting capability through the vent hole, making the system self-sufficient. No external venting devices or additional surgical steps are required, as the structure automatically relieves pressure during insertion.

Inventive Principle:

Principle #25Self-service

3Reliability

If multiple surgical steps are required for venting and securing the connection, then connection security is improved, but ease of operation during surgery deteriorates

Engineering Contradiction:

Improveconnection securityVSAvoidsurgical procedure simplicity

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The vent hole is pre-positioned in the lead channel during manufacturing, so that venting capability is already prepared before surgery. This preliminary action eliminates the need for intraoperative venting steps, simplifying the surgical procedure while maintaining connection security.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The venting function is extracted from the complex multi-step surgical process and built into the device structure itself. This extraction eliminates unnecessary surgical steps, making the procedure simpler while maintaining the same level of connection security.

Inventive Principle:

Principle #2Taking out (Extraction)

4Reliability

If the lead channel is completely sealed during insertion, then fluid leakage is prevented, but air compression increases insertion force

Engineering Contradiction:

Improveseal integrityVSAvoidinsertion force

Core Design Contradiction:

ReliabilityVSForce

Solution Approach 1:

The seal quality varies locally along the lead channel: the vent hole region allows air escape with minimal resistance, while the gasket region provides strong sealing. This local differentiation of seal quality enables low insertion force while maintaining overall seal integrity.

Inventive Principle:

Principle #3Local quality

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

This design reduces the risk of lead terminal dislodgment and electrical leakage, providing a reliable and easy-to-use sealed connection suitable for sensitive medical implants by minimizing pressurization and eliminating the need for complex venting or securing procedures during surgery.

Implementation Method 1

a vent to equalize pressure during insertion of a lead terminal into the lead channel

Methodology Applied

Scientific EffectPressure equalization: Pressure Gradient

Data Source

PatentUS9682226B2Electronic lead connection and related devices

Publication Date: 2017.06.20 ENVOY MEDICAL CORP

AI summary

Described are lead connections for electrically connecting a lead terminal and a lead channel; the lead connection can be useful in an electronic device such as an implantable electronic device, such as a hearing implant.