Blunt-Tip Lead Delivery Sheath for Minimally Invasive Cardiac Implantation
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Solution Overview
Problem
Existing methods for implanting cardiac leads, such as those used in pacemakers and defibrillators, often cause damage to surrounding tissues due to sharp tips and require invasive surgical incisions, posing risks to critical structures like the pericardium and vascular structures.
Innovation Solution
A method and system involving an insertion dilator and sheath that facilitate minimally invasive insertion of leads by using blunt tips and a delivery system with controlled deployment, reducing tissue damage and allowing precise positioning without surgical incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If sharp tips are used to penetrate skin and tissue, then lead insertion is achieved, but tissue damage occurs
Solution Approach 1:
Instead of using a sharp tip to penetrate tissue, the patent uses a blunt tip that pushes tissue aside. The insertion dilator has a blunt distal end that separates tissue planes through mechanical displacement rather than cutting, thereby achieving lead insertion while avoiding tissue damage
Solution Approach 2:
The insertion sheath acts as an intermediary device that guides the blunt-tipped insertion dilator through the tissue. The sheath provides a protected pathway, allowing the blunt dilator to separate tissue planes without direct exposure of sharp edges to surrounding structures
2Ease of operation
If surgical incisions are made to implant leads, then lead placement is achieved, but invasive procedures and risks to critical structures increase
Solution Approach 1:
The insertion dilator with blunt tip is used to pre-separate tissue planes before lead insertion. By creating a pathway through tissue displacement rather than incision, the system enables lead placement without surgical cutting, thereby reducing risks to critical structures like the pericardium and vascular structures
Solution Approach 2:
The insertion sheath is a flexible tubular structure that allows the blunt-tipped dilator to navigate through tissue planes. The flexible nature of the sheath accommodates tissue movement while maintaining a protected pathway, enabling minimally invasive lead placement
3Object-affected harmful factors
If blunt tips are used to separate tissue, then tissue damage is reduced, but insertion capability must be enhanced
Solution Approach 1:
The insertion system is divided into multiple functional components: the insertion dilator with blunt tip for tissue separation, the insertion sheath for guidance and protection, and the delivery system for controlled lead deployment. This segmentation allows each component to be optimized for its specific function, enhancing overall insertion capability while maintaining tissue safety
Solution Approach 2:
The insertion dilator is inserted within the insertion sheath, which itself is part of the larger delivery system. This nested configuration allows the blunt-tipped dilator to be delivered through the sheath to the target site, then removed, leaving the sheath in place for controlled lead deployment through the insertion tip
Data Source
AI summary
Systems and methods are disclosed that include inserting an insertion dilator into an insertion sheath such that the insertion dilator extends out from a distal end of an insertion sheath, penetrating patient skin with the insertion dilator to push the insertion sheath through the skin to reach a particular depth, removing the insertion dilator from the insertion sheath, inserting a delivery system into the insertion sheath, and deploying a lead by advancing the lead through an insertion tip of the delivery system.