Single-site S-ICD Implantation via Intercostal Tunneling
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Solution Overview
Problem
Conventional subcutaneous implantable cardioverter-defibrillators (S-ICDs) require multiple incisions for implantation, increasing the risk of infection and other complications, and may not deliver sufficient energy for defibrillation effectively.
Innovation Solution
A method for implanting S-ICDs using a single incision site, where the pulse generator and leads are positioned through tunnels extending over or along intercostal gaps, with the pulse generator positioned subcutaneously or submuscularly, and leads anchored to the deep fascia, allowing for efficient energy delivery for defibrillation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple incisions are used for implanting S-ICD leads and pulse generator, then complete implantation is achieved, but the risk of infection and other complications increases
Solution Approach 1:
The patent combines multiple implantation procedures (lead insertion and pulse generator placement) into a single incision site. The retrograde approach allows both the lead and pulse generator to be introduced through one incision in the subxiphoid region, eliminating the need for separate incisions at the axilla and sternum, thereby reducing infection risk while maintaining complete implantation functionality
Solution Approach 2:
The patent introduces a tunneling tool as an intermediary device to facilitate the retrograde passage of leads and pulse generator through subcutaneous tissue. This intermediary tool enables navigation from the single incision site to the required electrode positions without requiring additional incisions, thus reducing complication risks while achieving proper device placement
2Use of energy by moving object
If conventional S-ICD configuration is used, then implantation is simpler, but sufficient energy delivery for defibrillation cannot be achieved
Solution Approach 1:
The patent repositions the pulse generator in the subxiphoid region rather than the conventional axillary position, and routes leads through intercostal spaces to achieve optimal electrode positioning. This spatial reconfiguration in multiple dimensions enables improved defibrillation energy delivery through better current distribution across the heart while maintaining a streamlined single-incision implantation approach
3Reliability
If transvenous leads are used in ICD, then defibrillation capability is achieved, but venous access difficulties and lead dislodgement risks increase
Solution Approach 1:
The patent extracts the leads from the venous system and places them entirely in the subcutaneous space, eliminating the need for venous access. The retrograde subcutaneous approach allows leads to be positioned without entering veins, thereby avoiding venous access difficulties, lead dislodgement, and other complications associated with transvenous placement while maintaining defibrillation capability
Data Source
AI summary
Methods and devices include making an incision at a single site of a patient. The single site located at an anterior of a chest or abdomen. The method also includes inserting a tunneling tool through the incision at the single site and preparing a first tunnel to a subcutaneous posterior location. A path of the first tunnel at least one of i) extends over a plurality of Intercostal gaps of the chest or ii) extends along and within one of the intercostal gaps. The method also includes positioning a first lead having an electrode within the first tunnel and preparing a second tunnel to a subcutaneous parasternal location along the chest. The method also includes positioning a second lead having an electrode within the second tunnel and positioning a pulse generator within a subcutaneous pocket and operatively coupling the first and second leads to the pulse generator.