Expandable Fixator for Cardiac Lead Delivery
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Solution Overview
Problem
Existing methods for implanting cardiac leads require slitting of catheters during lead delivery, which is skill-intensive, prone to user error, and restricts catheter design, making the process inefficient and error-prone.
Innovation Solution
A lead delivery device with a removably anchorable guidewire and an expandable fixator that temporarily anchors the guidewire in a blood vessel, allowing the catheter to be removed without slitting, and enables the electrically conductive lead to be advanced over the guidewire in a zip-line manner without moving the guidewire, using a fixator that transitions from a compact to an expanded configuration to exert a holding force of 0.89 to 4.45 N.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If catheter slitting is used for lead delivery, then lead delivery can be achieved, but the process becomes skill-intensive and prone to user error
Solution Approach 1:
The invention extracts the problematic slitting step from the lead delivery process by using a separate guidewire delivery system. The guidewire is delivered through the catheter lumen and then used to pull the lead through the catheter without requiring the catheter to be slit, thereby eliminating the skill-intensive and error-prone slitting operation.
Solution Approach 2:
The guidewire acts as an intermediary element that facilitates lead delivery through the catheter. Instead of directly manipulating the catheter structure (slitting), the guidewire serves as a mediator that the lead can be pulled along, simplifying the operator's task and reducing errors.
2Ease of operation
If catheter slitting is performed, then lead delivery is enabled, but catheter design is restricted
Solution Approach 1:
The invention removes the requirement for catheter slitting from the lead delivery mechanism. By extracting this constraint, catheter designers are free to optimize catheter design for other performance parameters such as flexibility, durability, and delivery characteristics without being limited by the need to incorporate slitting features.
3Productivity
If traditional lead delivery methods are used, then leads can be delivered, but the process is inefficient and error-prone
Solution Approach 1:
The guidewire is delivered and positioned in the vessel before the lead is pulled through the catheter. This preliminary action establishes a secure pathway and anchor point, making the subsequent lead delivery straightforward and reducing the likelihood of errors during the actual lead insertion process.
Data Source
AI summary
A medical apparatus includes an electrically conductive lead for a medical device, the lead having an internal bore terminating at a distal lead opening, and a lead delivery device for delivering the distal end of the lead to a blood vessel during implantation of the lead. The lead delivery device includes a removably anchorable guidewire, and a fixator attached to a distal portion of the guidewire for anchoring the guidewire. The fixator is movable between a compact configuration and an expanded configuration. The fixator is capable of passing through the distal lead opening of the lead in the compact configuration. The fixator is capable of exerting a holding force in the range of about 0.89 to 4.45 N in the lumen of the blood vessel in the expanded configuration.