Threaded Ferrule Locking Mechanism for Implantable Leads

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Solution Overview

Problem

Existing locking mechanisms for implantable medical devices, such as set screws, lead to contamination, leakage, and increased complexity due to metal shavings, lack of visual inspection, and require additional sealing and tool usage, which can result in disconnection and loss during surgery.

Innovation Solution

A locking and sealing mechanism using a sleeve with a first threaded member and a lead with a ferrule or molded bead, where a second threaded member engages to secure and seal the lead within the device, eliminating the need for set screws and allowing visual inspection without additional tools.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a set screw is used to secure the lead, then the lead can be restrained and connected, but metal shavings enter the lead cavity causing contamination and the device requires additional sealing and tool usage

Engineering Contradiction:
Improvelead connection securityVSAvoidmetal shavings contamination
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the set screw component entirely from the system. Instead of using a set screw that creates metal shavings, the invention uses a lead end cap with a push-button release mechanism that secures the lead without threaded fasteners, thereby eliminating the source of metal shavings and contamination

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a lead end cap as an intermediary component between the lead and the connector housing. This end cap with its push-button mechanism serves as a mediator that provides secure lead retention without requiring metal threaded fasteners, thus preventing contamination while maintaining connection security

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a set screw is used to secure the lead, then the lead can be locked in place, but there is no opportunity for visual inspection and the connection security cannot be ensured

Engineering Contradiction:
Improvelead connection securityVSAvoidvisual inspection capability
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent incorporates visual indicators into the lead end cap assembly. The push-button mechanism and its position relative to the connector housing provide visible cues that indicate whether the lead is properly secured. The transparent or translucent portions of the end cap allow visual inspection of the lead position and connection status

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent divides the lead end cap into separable components including the push-button and the cap body. This segmentation allows the button to be pressed to release the lead while providing visual access to the internal components, enabling inspection of the connection security without requiring disassembly

Inventive Principle:
Principle #1Segmentation

3Reliability

If a set screw hole is created in the device, then the lead can be secured, but the hole becomes a potential leakage source requiring silicone filler sealing

Engineering Contradiction:
Improvelead connection securityVSAvoidbody fluid leakage
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent eliminates the set screw hole entirely by removing the set screw mechanism. The lead is secured through friction fit and the push-button retention mechanism within the end cap, which does not require penetrating the connector housing, thereby eliminating the leakage pathway that would require sealing

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent combines the lead retention function and the sealing function into a single integrated lead end cap component. The end cap secures the lead while simultaneously maintaining the integrity of the connector housing, eliminating the need for separate sealing operations with silicone filler

Inventive Principle:
Principle #5Merging (Combining)

4Reliability

If a set screw assembly is used, then the lead can be secured, but the device complexity increases and additional tools are required for operation

Engineering Contradiction:
Improvelead connection securityVSAvoiddevice structure and operation
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent removes the set screw assembly entirely from the device. The lead retention function is achieved through the integrated end cap with push-button mechanism, eliminating the need for separate set screws, threaded holes, and sealing components, thereby reducing device complexity

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The push-button mechanism on the lead end cap allows the user to secure and release the lead using only their fingers. The button presses against a spring-loaded or friction-based retention mechanism, providing tool-free operation and simplifying the user interface without compromising connection security

Inventive Principle:
Principle #25Self-service

5Reliability

If a set screw is used to secure the lead, then the lead can be restrained, but the screw can become accidentally disconnected and lost in the body

Engineering Contradiction:
Improvelead connection securityVSAvoiddisconnection and loss of components
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent combines the lead retention function and the release mechanism into a single integrated lead end cap assembly. The push-button is part of the end cap structure, and when pressed, it releases the lead in a controlled manner. This integration ensures that no separate small components can become disconnected and lost in the body

Inventive Principle:
Principle #5Merging (Combining)

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 solution provides a secure, leak-proof connection with improved visibility and reduced complexity, preventing contamination and ensuring the lead is properly locked in place without the risk of disconnection during surgery.

Implementation Method 1

The inserted set screw radially engages the side of the lead, applying a force or mechanical interference between the end of the screw and the lead, thereby securing the position of the lead within the medical device

Methodology Applied
Scientific EffectFriction: Friction

Implementation Method 2

a first threaded member extending externally of the medically implantable device, and an opening running longitudinally from an end of the first threaded member into the medically implantable device

Methodology Applied
Scientific EffectThreading: Screw

Implementation Method 3

wherein the locking mechanism also seals the opening from the outside environment

Methodology Applied
Scientific EffectSealing:

Data Source

PatentUS8092260B2Device for securing leads into in-line connector devices
Publication Date: 2012.01.10 BAL SEAL ENG CO INC
  • US8092260B2 patent drawing
  • US8092260B2 patent drawing
  • US8092260B2 patent drawing

AI summary

A locking device for connectors is provided that uses a threaded seal latch application using a ferrule. The locking device secures leads in electrical connectors, particularly connectors involved in medically implantable devices. The locking device utilizes a threaded nut, pre-assembled onto a lead cable with a ferrule. The lead cable is inserted into and engages with a threaded sleeve, the threaded sleeve serves as an opening for the in-line stack inside a housing. The threaded nut engages the threaded sleeve, and the ferrule along the lead cable is encased therebetween. The ferrule is pushed into and against the inner surface of the threaded sleeve by the threaded nut, tightly securing the ferrule in place, and thereby locking the lead cable in the desired position.