Leadless Pacemaker Tether Holder Deployment Mechanism

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Solution Overview

Problem

Current interventional medical systems face challenges in efficiently deploying compact implantable medical devices due to mechanical complications and MRI compatibility issues associated with elongate lead wires, necessitating improved tools for percutaneous transvenous deployment.

Innovation Solution

The development of an interventional medical system featuring a tether management system with a tether assembly, handle assembly, and inner assembly, including a deployment tube with a movable distal portion and a tether holder with locking and flushing subassemblies, to facilitate secure and controlled deployment of implantable medical devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If elongate lead wires are used in traditional pacemakers, then electrical connection to the heart is achieved, but mechanical complications and MRI compatibility issues occur

Engineering Contradiction:
Improveelectrical connection reliabilityVSAvoidmechanical complications and MRI compatibility issues
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes the elongate lead wires from the pacemaker system, replacing them with a leadless architecture where the pulse generator is implanted directly in the heart chamber. This eliminates the harmful mechanical complications and MRI compatibility issues associated with lead wires while maintaining electrical connection functionality through direct contact electrodes.

Inventive Principle:
Principle #2Taking out (Extraction)

2Object-affected harmful factors

If a compact leadless pacemaker is deployed, then mechanical complications are reduced, but deployment precision and control become more challenging

Engineering Contradiction:
Improvemechanical complicationsVSAvoiddeployment precision
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The patent employs a dynamic deployment mechanism where the compact pacemaker is initially contained within a deployable catheter structure that can be manipulated and positioned with precision. The device transitions from a constrained state within the catheter to a deployed state in the heart chamber, allowing precise placement while maintaining compact form factor.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent uses a deployable catheter as an intermediary tool to facilitate precise deployment of the compact pacemaker. The catheter serves as a mediator that enables controlled delivery and positioning of the device, overcoming the challenges of deploying a compact device with high precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If tether management features are added to the deployment tool, then device positioning control is improved, but device complexity increases

Engineering Contradiction:
Improvedevice positioning controlVSAvoidtool structure complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent segments the deployment tool into distinct functional modules including a tether management feature, a deployable catheter, and a positioning mechanism. Each segment performs a specific function, allowing the tether to be independently managed for device positioning control while keeping the overall system organized and manageable despite increased complexity.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3049149B1Interventional medical systems, tools, and assemblies
Publication Date: 2018.01.03 MEDTRONIC INC
  • EP3049149B1 patent drawingFigure 1
  • EP3049149B1 patent drawingFigure 2A~2B
  • EP3049149B1 patent drawingFigure 3A~3B

AI summary

A tether holder has a locking portion, for securing a proximal end of a tether, and a pin portion that fits within a receptacle of a handle assembly of a tool. A distal member of an inner assembly of the tool engages an implantable medical device, from which the tether extends through at least one lumen of the inner assembly and out through a proximal port of the handle assembly, which is located in proximity to the receptacle. An enlarged distal-most portion of a deployment tube of the tool contains the distal member and the device, and is moveable, relative to the inner assembly and the device, to deploy the device out through a distal opening of the tool. The handle assembly may also include a flush lumen and a tether engaging conduit, both in fluid communication with the at least one lumen of the inner assembly.