Deflectable Peelable Mapping Sheath for Bundle of His Pacing
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Solution Overview
Problem
Current cardiac resynchronization therapy (CRT) devices face challenges in locating and accurately implanting electrode leads in the small and faintly signaling bundle of His, due to conventional lead delivery methods' limitations, which prolong procedure times and often result in unsuccessful His pacing lead placement.
Innovation Solution
A deflectable and peelable mapping guide sheath with a handle, elongated design, flexible sections, and splitable construction, equipped with a pull wire and mapping electrodes, allows for precise positioning and fixation of pacing leads within the bundle of His, facilitating easier access and removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional lead delivery methods are used to locate the bundle of His, then the procedure becomes simpler in terms of device structure, but the procedure time increases significantly and placement accuracy decreases
Solution Approach 1:
The delivery device is divided into distinct functional segments: a mapping guide sheath with mapping electrodes for locating the bundle of His, and a separate pacing lead delivery mechanism. This segmentation allows the mapping function to be performed efficiently before lead implantation, reducing overall procedure time while maintaining high localization accuracy.
Solution Approach 2:
The mapping guide sheath acts as an intermediary device between the conventional delivery system and the bundle of His. It carries mapping electrodes that can detect electrical signals from the bundle of His, enabling precise localization without requiring complex imaging or navigation systems, thus reducing procedure time while improving accuracy.
2Reliability
If conventional lead delivery devices are used, then device complexity is reduced, but the ability to maintain lead position during affixation deteriorates
Solution Approach 1:
The mapping guide sheath and pacing lead delivery function are merged into a single integrated device. The sheath provides both mapping capability and a stable platform for lead affixation, ensuring lead position stability while avoiding the need for multiple separate complex devices.
Solution Approach 2:
The mapping guide sheath is used to preliminarily locate and stabilize the bundle of His position before the pacing lead is fully implanted. This preliminary action ensures that the lead is positioned accurately and stably from the beginning, reducing the need for adjustments and improving overall reliability.
3Strength
If a delivery sheath is used to protect the pacing lead, then lead protection is improved, but sheath removal becomes more difficult and risks lead dislodgement
Solution Approach 1:
The mapping guide sheath is constructed as a flexible, thin-walled device that can be easily manipulated and removed. The sheath maintains sufficient strength to protect the pacing lead during insertion and positioning, but its flexible nature allows for smooth removal without risking lead dislodgement, improving ease of operation while maintaining protection.
Data Source
AI summary
A delivery device for delivering a pacing lead to a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal end face, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position exposed on or spaced from the distal end face. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a substantially straight configuration to a dual hinged curved configuration that maneuvers and positions the electrodes in the vicinity of the bundle of His. The sheath may include a PTFE liner having axially oriented, platelet-like fibril features that enable the sheath to be split along its length from a proximal end to the distal end.