Flexible Necked Tunneling Tool for Atraumatic Lead Pathway
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Solution Overview
Problem
Current subcutaneous implantable cardioverter-defibrillator (ICD) systems are large, uncomfortable for patients, prone to skin erosion, and unable to deliver anti-tachycardia pacing, while existing tunneling tools lack maneuverability and risk damaging sensitive tissues during medical lead insertion.
Innovation Solution
A medical device with an elongate shaft and a necked portion that is resiliently movable, allowing for atraumatic pathway creation from the xiphoid process to the sternum or pericardium, using a flexible and malleable design to minimize tissue damage and facilitate energy-efficient defibrillation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a SubQ ICD system is used to deliver electrical impulses subcutaneously, then defibrillation can be achieved, but the device size becomes large requiring high energy output (around 80J) which compromises patient comfort and causes skin erosion
Solution Approach 1:
The implantable device is divided into two separate components: a small implantable pulse generator (IPG) and an external wearable controller. The IPG contains only the essential defibrillation functionality with minimal battery and circuitry, while the external controller houses the majority of the processing, sensing, and high-voltage generation capabilities. This segmentation allows the implanted portion to be small and comfortable while maintaining full defibrillation effectiveness through the external unit.
Solution Approach 2:
An external wearable controller acts as an intermediary between the patient and the implantable device. This external unit communicates with the IPG via wireless or wired connection, providing the necessary high-energy output for defibrillation without requiring the implanted device to be large. The external controller serves as a mediator that delivers the high power needed while keeping the implanted portion small and comfortable.
2Reliability
If a SubQ ICD system is used, then defibrillation can be delivered, but the system is incapable of delivering anti-tachycardia pacing (ATP) therapy
Solution Approach 1:
The external wearable controller is designed to provide multiple therapeutic functions including defibrillation, anti-tachycardia pacing (ATP), and cardioversion. By consolidating these diverse therapeutic capabilities in the external unit while maintaining a simple implantable generator, the system achieves universal functionality without requiring the implanted device to be complex or large. This allows delivery of both high-energy defibrillation and low-energy pacing therapies through a unified system.
3Ease of manufacture
If fixed configuration tunneling tools are used to create subcutaneous pathway, then lead implantation can be performed, but the tools provide limited maneuverability through tough tissues and risk damaging sensitive tissues
Solution Approach 1:
The tunneling tool incorporates a dynamic, flexible shaft design that can bend and adapt to the anatomical pathway rather than following a fixed rigid configuration. The shaft includes segments that can flex and rotate, allowing the operator to navigate around obstacles and through tough tissues while maintaining control. This dynamic design enables the tool to conform to the natural curvature of the subcutaneous space from the xiphoid process to the sternum without risking damage to sensitive underlying structures.
Solution Approach 2:
The tunneling tool employs a flexible shaft constructed from layered materials or memory alloy components that provide controlled flexibility. This flexible construction allows the shaft to bend and follow the natural anatomical pathway while maintaining structural integrity. The flexibility enables safe navigation through the subcutaneous space without puncturing sensitive tissues such as the heart or lungs, while still providing sufficient rigidity to effectively create the implantation pathway.
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 minimally traumatic implantation of medical leads with reduced energy output, avoiding damage to sensitive tissues and improving patient comfort by providing a flexible and efficient pathway for medical lead insertion.
Implementation Method 1
the necked portion being at least resiliently movable in a direction normal to the major longitudinal axis
Data Source
AI summary
A method and device for implanting a medical lead. The device includes an elongate shaft defining a major longitudinal axis and including a proximal end and a distal end. A necked portion coupled to and extending from the distal end is included, the necked portion defines a first thickness and a substantially planar surface, the necked portion being at least resiliently movable in a direction normal to the major longitudinal axis. A tip disposed at the distal end of the necked portion is included, the tip defining a second thickness greater than the first thickness.