Magnetic Navigation Sheath for Cardiac Conduction Bundle Pacing
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Solution Overview
Problem
Current sheaths for cardiac conduction bundle pacing lack precision and adjustability, leading to low success rates, long procedure times, and risks of myocardial perforation due to limited adjustment ranges and low precision in controlling the angle and depth of pacemaker lead insertion.
Innovation Solution
A magnetic navigation-guided tear-away sheath with a flexible section equipped with half-ring magnets for adjustable bending, integrated electrodes for potential recording, and an incision guidewire for precise cutting, facilitating stable attachment and precise positioning of pacemaker leads within the cardiac conduction bundle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a conventional fixed or bendable sheath is used for pacemaker lead implantation, then the sheath can provide basic support and guidance, but the adjustment range is limited and positioning precision is low
Solution Approach 1:
The sheath incorporates a flexible section with magnetic particles that can be dynamically adjusted in real-time through external magnetic fields. This allows the sheath to transition from a static structure to a dynamically controllable one, enabling precise positioning and angle adjustment during the procedure while maintaining overall structural simplicity.
Solution Approach 2:
The patent replaces traditional mechanical adjustment mechanisms with magnetic field control. Instead of requiring complex mechanical hinges, joints, or manual manipulation tools, the sheath uses magnetic particles responsive to external magnetic fields for positioning and orientation, significantly simplifying the mechanical structure while enhancing positioning precision.
2Reliability
If the pacemaker lead is screwed deeply into the heart wall to ensure stable pacing, then the pacing stability improves, but the risk of myocardial perforation increases
Solution Approach 1:
The sheath incorporates electrodes that can record intracardiac potentials and provide real-time feedback on the position and depth of the pacemaker lead. This feedback mechanism allows the operator to monitor lead placement accuracy and adjust the insertion depth accordingly, ensuring stable pacing while avoiding excessive depth that could cause myocardial perforation.
Solution Approach 2:
The magnetic navigation system allows preliminary positioning and angle adjustment of the sheath and pacemaker lead before final implantation. By pre-positioning the lead at the optimal angle and depth using magnetic guidance, the system ensures stable pacing attachment while preventing overly deep insertion that could lead to perforation.
3Ease of operation
If the sheath structure is made more complex to improve positioning precision and adjustability, then the control over insertion angle and depth improves, but the device complexity increases
Solution Approach 1:
The patent replaces complex mechanical adjustment systems with magnetic field control. The flexible section containing magnetic particles can be precisely positioned and oriented using external magnetic fields, achieving high control precision without adding mechanical complexity to the sheath structure.
Solution Approach 2:
The sheath utilizes changes in magnetic field parameters (strength, direction, gradient) to control the orientation and position of the flexible section. By varying magnetic field parameters rather than mechanical configurations, the system achieves precise control over insertion angle and depth while maintaining structural simplicity.
4Adaptability or versatility
If multiple adjustment mechanisms are added to the sheath to accommodate anatomic variations and improve positioning accuracy, then the adaptability to different cardiac anatomies improves, but the device complexity and procedure time increase
Solution Approach 1:
The magnetic navigation system provides dynamic, real-time adjustment capabilities that adapt to various cardiac anatomies without requiring multiple pre-configured mechanical mechanisms. The flexible section with magnetic particles can be continuously repositioned and reoriented during the procedure to accommodate anatomical variations, reducing the need for time-consuming trial-and-error adjustments.
Solution Approach 2:
The sheath design with magnetic particles and integrated electrodes serves multiple functions: positioning, angle adjustment, and electrical recording. This multi-functionality within a single integrated structure improves adaptability to different anatomies without requiring multiple separate adjustment mechanisms, thereby reducing procedure time.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enhances precision and stability of pacemaker lead placement, reduces the risk of myocardial perforation, and improves procedure success rates by allowing flexible adjustment and accurate positioning within the cardiac conduction bundle, while enabling imaging and safe removal of the sheath.
Implementation Method 1
an outer surface near a head end of the front flexible section is provided with a plurality of pairs of half-ring magnets, two half-ring magnets in each pair of half-ring magnets are symmetrically disposed and form a ring
Implementation Method 2
the head end of the front flexible section is further provided with three electrodes uniformly disposed in a circumferential direction, the three electrodes can be freely combined two by two, to form three electrode pairs, the three electrode pairs are capable of recording three local double-electrode potentials of the heart and are used to record and position an intracardiac potential
Data Source
AI summary
The present invention relates to a magnetic navigation-guided tear-away sheath for cardiac conduction bundle pacing, including a sheath body and a joint fixedly connected to a rear end of the sheath body. The sheath body includes a front flexible section and a rear fixed section, and the front flexible section is freely bendable. An outer surface near a head end of the front flexible section is provided with a plurality of pairs of half-ring magnets, two half-ring magnets in each pair of half-ring magnets are symmetrically disposed and form a ring, and a gap is kept between the two half-ring magnets. The head end of the front flexible section is provided with three electrodes uniformly disposed in a circumferential direction, and the three electrodes can be freely combined two by two, to form three electrode pairs used to record and position an intracardiac potential.