Cardiac Lead Wire Protector Sheath Segmentation
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Solution Overview
Problem
Intracardiac pacemaker and implantable cardiac defibrillator leads are prone to fractures, particularly at the clavicle and first rib site, due to external stresses and body movement, which can lead to catastrophic results, despite the subclavian approach being a popular method for implantation.
Innovation Solution
A detachable sheath tip and body are designed to remain around the lead wire as a protector tube, providing additional support and protection by being made of biocompatible materials like silicone, with a grommet and optional plug for anchoring and preventing back bleeding, allowing for the sheath to be partially torn away post-implantation to reduce fracture risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard sheath is used for subclavian vein access and completely removed after lead placement, then the implantation procedure is simple and fast, but the lead wire is vulnerable to fracture and crush at the clavicle and first rib site
Solution Approach 1:
The sheath is divided into two distinct segments: a removable proximal portion containing the valve and side port, and a permanent distal tip/body portion that remains as a protector tube. This segmentation allows the sheath to provide ongoing fracture protection while still enabling complete removal of the non-essential components, directly resolving the contradiction between reliability and device complexity
Solution Approach 2:
The sheath tip/body is pre-configured as a protective tube during manufacturing, before implantation. This preliminary preparation ensures that the protective function is already in place and requires no additional steps during the implantation procedure, maintaining procedural simplicity while establishing reliable fracture protection
2Reliability
If a protector tube is left in place around the lead wire, then fracture risk is reduced, but the intravascular space requirements increase
Solution Approach 1:
The protector tube is designed to provide protection only at the specific critical location where the lead passes under the clavicle and through the first rib, rather than enclosing the entire lead length. This localized protection approach minimizes the volume occupied within the intravascular space while concentrating protective function where it is most needed, resolving the contradiction between reliability and space requirements
3Reliability
If the entire sheath is removed after lead placement, then the implantation procedure is straightforward, but additional protection at the tie-down site is lost
Solution Approach 1:
The sheath is segmented into a removable proximal portion and a permanent distal tip/body portion. The permanent portion remains positioned to protect the lead at the tie-down site and clavicular region, while the removable portion can be easily detached and removed. This segmentation resolves the contradiction by maintaining protection where needed while simplifying the removal of non-essential components
Solution Approach 2:
The permanent sheath tip/body acts as an intermediary protective structure that remains between the lead wire and the external environment at critical locations. This intermediary element provides ongoing protection at the tie-down site without requiring the entire sheath to remain in place, balancing reliability with ease of operation
Data Source
AI summary
A lead wire associated with a pacemaker, implantable cardiac defibrillator or other cardiac electric signal source is provided with a protector tube overlying at least a portion of the lead wire. In one embodiment, this protector tube is provided as a sheath tube portion of a sheath assembly along with a valve body. The valve body of the sheath assembly is fracturable and removable away from the sheath tube, leaving the sheath tube upon the lead wire as a protector tube. In other embodiments, a separate protector tube is provided and fed over the lead wire and through a sheath assembly until placed where desired. A grommet and/or plug can be provided at a proximal end of the protector tube for anchoring of the protector tube in a desired location and for plugging the protector tube, while also accommodating the lead wire passing therethrough.