Pacemaker Lead Extraction Device with Anchoring and Vibration

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Solution Overview

Problem

Current methods for extracting pacemaker or implantable cardioverter defibrillator leads from the body lack effective mechanisms to prevent movement and securely remove the leads without causing damage or complications.

Innovation Solution

A device with a lead receiving element and a coil engaging element that allows anchoring and vibration to securely lock the lead in place, featuring a retaining mechanism that can switch between retaining and non-retaining states to facilitate extraction, utilizing a deformable element and clamping members to maintain the lead's position during removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a lead is extracted from the body using conventional methods, then the lead can be removed, but the lead may move during extraction causing damage or complications

Engineering Contradiction:
Improveextraction safetyVSAvoidlead movement damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device performs preliminary actions by first receiving the lead in a controlled manner through the lead receiving element, then securing it with the retaining mechanism before extraction begins. The coil engaging element is positioned in advance to engage the coil, and the anchoring element is pre-placed within the lead lumen, ensuring the lead is fully secured before any extraction force is applied.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The device introduces an intermediary structure between the extraction force and the lead. The lead receiving element acts as an intermediary that captures and secures the lead, while the retaining mechanism serves as a mediator that controls the lead's position throughout extraction. This intermediary system prevents direct movement of the lead during extraction.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a retaining mechanism is added to prevent lead movement, then extraction safety is improved, but device complexity increases

Engineering Contradiction:
Improvelead retentionVSAvoidmechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is segmented into distinct functional elements: the lead receiving element for capturing the lead, the coil engaging element for securing the coil, the retaining mechanism for controlling lead position, and the anchoring element for internal lead anchoring. Each segment performs a specific function, allowing the complex retention task to be divided into manageable, independent components that work together.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The retaining mechanism is designed to be dynamic rather than static, allowing it to switch between retaining and non-retaining states. This dynamic capability enables the mechanism to adapt during different phases of extraction - securely holding the lead when needed and allowing controlled movement when appropriate - without requiring an overly complex fixed structure.

Inventive Principle:
Principle #15Dynamics

3Object-affected harmful factors

If the lead is securely retained during extraction, then damage is prevented, but the device structure becomes more complex

Engineering Contradiction:
Improveextraction damageVSAvoiddevice structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The device employs a nested structure where the anchoring element is positioned within the lead lumen, the coil engaging element surrounds and engages the coil, and the lead receiving element encompasses the entire lead assembly. This nested arrangement allows multiple retention functions to be integrated in a compact, space-efficient manner, reducing overall structural complexity while maintaining secure lead retention.

Inventive Principle:
Principle #7Nested doll (Nesting)

4Adaptability or versatility

If a deformable element is used for retention, then the retaining mechanism can switch states, but manufacturing precision requirements increase

Engineering Contradiction:
Improvestate switching capabilityVSAvoiddeformation control
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The deformable element utilizes parameter changes in its physical state to achieve state switching. By changing parameters such as applied force, temperature, or material phase, the element can transition between retaining and non-retaining states. This approach allows versatile state switching while relying on well-understood material properties rather than requiring extreme manufacturing precision.

Inventive Principle:
Principle #35Parameter changes

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

Enables safe and effective extraction of pacemaker or ICD leads by preventing movement and ensuring secure retention, reducing the risk of damage during the extraction process.

Implementation Method 1

at least a portion of the lead receiving element is deformable upon external application of force thereon resulting in at least one of: (i) a reduction of at least a portion of the lumen cross section or (ii) an increase of pressure on a lead received in the lumen

Methodology Applied
Scientific EffectDeformation: Deformation

Implementation Method 2

The first end of the coil engaging element is configured to engage a coil of a lead of a pacemaker or ICD that is disposed within the lumen of the lead. The engagement of the coil engaging element is intended to engage the end of said coil and to compress it upon application of force along a common axis defined by the lumen and the coil engaging element.

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 3

The device is designed to prevent any movement of the lead and/or the coil of the pacemaker or ICD and allowing to extract the lead by an anchoring member (e.g. a stylet that is designed to be introduced into that lead and to anchor in a certain portion within the lumen of the lead) and/or applying vibrations thereto through the anchoring member.

Methodology Applied
Scientific EffectVibration: Vibration

Data Source

PatentUS20240252208A1Lead retaining device
Publication Date: 2024.08.01 XTRAC O S LTD
  • US20240252208A1 patent drawing
  • US20240252208A1 patent drawing
  • US20240252208A1 patent drawing

AI summary

The present disclosure provides a device for assisting in the extraction of a lead of a pacemaker or implantable cardioverter defibrillator (ICD) from a subject. The device is therefore capable of correcting most life-threatening cardiac arrhythmias. The device is designed to prevent any movement of the lead and/or the coil of the pacemaker or ICD and allowing to extract the lead by an anchoring member (e.g. a stylet that is designed to be introduced into that lead and to anchor in a certain portion within the lumen of the lead) and/or applying vibrations thereto through the anchoring member. The device is configured to allow the anchoring member to pass therethrough such that it is locked to a certain position within the lumen of the lead at a first end thereof and the second end is available for applying vibrations thereto and pulling it to extract the lead.