Pacemaker Lead Anchoring via Ferrule Holders and Anchor Sutures
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Solution Overview
Problem
Current pacemaker lead placement methods in pediatric patients face challenges such as the need for sternotomy or thoracotomy, higher chronic stimulation thresholds, lead failures, and risks associated with endocardial implantation, including dislodgment and endocarditis.
Innovation Solution
A surgical device and method for pacemaker lead placement that uses a pediatric scope port, anchor sutures, and ferrule holders to secure the lead without the need for sternotomy or thoracotomy, allowing for minimally invasive placement and anchoring to the heart tissue using a minimally invasive surgical suturing device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional epicardial lead placement is performed via sternotomy or thoracotomy, then the lead can be secured to the heart, but the procedure causes significant patient trauma, longer recovery time, and higher chronic stimulation thresholds
Solution Approach 1:
The surgical approach is segmented into two distinct routes: epicardial access through a small subxiphoid incision and endocardial access through venous catheterization. This segmentation allows the surgeon to choose the appropriate access method based on patient size and anatomy, avoiding the need for large sternotomy or thoracotomy incisions while still achieving secure lead placement
Solution Approach 2:
The device employs nested components including the lead tip fitting within the anchoring device, and the anchoring device being delivered through a catheter system. This nesting allows minimally invasive delivery of the anchoring mechanism through venous access, avoiding external incisions while enabling secure attachment to the heart tissue
2Reliability
If endocardial (transvenous) lead placement is used, then venous access is avoided and pacing thresholds are lower, but the risk of lead dislodgment, venous occlusion, embolic vascular events, and endocarditis increases
Solution Approach 1:
The device performs preliminary anchoring of the lead tip to the endocardial surface before final lead deployment. The expandable anchoring structure is deployed first to secure attachment points on the heart tissue, then the lead is advanced and secured to these pre-established anchors, preventing dislodgment while maintaining a closed system that reduces infection risk
Solution Approach 2:
The expandable anchoring device serves as an intermediary between the lead and the heart tissue. It provides a secure mechanical connection point that distributes forces evenly across the endocardial surface, reducing the risk of lead dislodgment and tissue damage while maintaining a barrier that reduces infection risk
3Adaptability or versatility
If epicardial lead placement is performed, then venous access is preserved for future use, but the procedure requires sternotomy or thoracotomy and is associated with higher lead failures and fractures
Solution Approach 1:
The procedure segments the access routes, allowing venous access to be used for lead delivery while a separate small subxiphoid incision provides access for the anchoring device. This segmentation enables the lead to be delivered through veins (preserving future venous access) while the anchoring mechanism is applied through a different route, reducing mechanical stress on the lead and improving lead integrity
Solution Approach 2:
The expandable anchoring structure acts as an intermediary that secures the lead to the heart tissue without requiring the lead itself to bear the full mechanical load of attachment. This reduces stress on the lead, minimizing the risk of lead fractures and failures while preserving venous access
4Ease of operation
If minimally invasive approach is used, then patient pain and recovery time are reduced, but the complexity of the device and procedure increases
Solution Approach 1:
The anchoring device employs dynamic, shape-memory alloy components that automatically change shape in response to temperature changes or mechanical stimulation. The lead tip expands from a compressed delivery configuration to an expanded anchoring configuration once deployed, providing secure attachment without requiring complex mechanical actuation systems, thus balancing minimally invasive delivery with reliable anchoring
Data Source
AI summary
A device for pacemaker lead placement is disclosed. The device has a device tip having a tissue bite area, ferrule holders, and needle tips. The device also has a lead end rest at the distal end, with a pacemaker lead end situated on the lead end rest, the pacemaker lead end having first and second anchor suture holes. The device further has an anchor suture with ferrules at respective ends of the anchor suture, wherein the ferrules of the anchor suture are passed through the anchor suture holes and into communication with the ferrule holders. The device further has one or more tube guides configured to organize and manage sutures during a minimally invasive surgical procedure.