Out of Plane Deflectable Catheters for His Bundle Pacing
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Solution Overview
Problem
Current medical electrical lead implantation techniques, particularly for His bundle pacing, face challenges in accurately locating and stabilizing the lead at the target site due to the complexity of cardiac anatomy and limited visualization, leading to inefficient procedures and potential misplacement.
Innovation Solution
A steerable catheter with an articulating segment and preformed curve segments allows for three-dimensional deflection and precise positioning, equipped with radiopaque markers and an electrode array for fluoroscopic guidance and ECG signal detection to identify and stabilize the His bundle, facilitating the implantation of medical electrical leads.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a medical electrical lead is implanted using conventional catheter techniques, then the procedure can be performed with simpler equipment, but the precision of lead placement at the His bundle target site is insufficient
Solution Approach 1:
The catheter is divided into multiple functional segments: a steerable distal portion with articulating segments for navigation, a mid-portion with preformed curves for positioning, and a proximal portion for operator control. This segmentation allows each portion to be optimized for its specific function while working together to achieve precise lead placement at the His bundle
Solution Approach 2:
The catheter incorporates multiple articulating segments that enable deflection in multiple geometric planes (at least two planes), transforming a simple linear insertion tool into a three-dimensionally controllable device. This multi-planar articulation allows the operator to navigate the complex cardiac anatomy and position the lead precisely at the His bundle target site
2Manufacturing precision
If the catheter includes multiple articulating segments for three-dimensional deflection, then the positioning precision is improved, but the difficulty of operating the catheter increases
Solution Approach 1:
Radiopaque markers are incorporated as visual intermediaries that allow the operator to see the catheter's position and orientation within the fluoroscope field. These markers serve as mediators between the complex multi-planar articulation system and the operator's ability to control it, providing real-time visual feedback for precise positioning at the His bundle
Solution Approach 2:
The complex mechanical articulation system is complemented by fluoroscopic imaging and radiopaque markers, replacing the need for direct tactile or visual feedback. The operator controls the multi-planar articulation based on two-dimensional fluoroscopic images showing the radiopaque markers, translating mechanical control into precise three-dimensional positioning
3Productivity
If conventional catheters are used for lead implantation, then the procedure setup is simpler, but the procedure duration and resource consumption increase
Solution Approach 1:
The catheter integrates multiple functions into a single device: navigation through complex anatomy via multi-planar articulation, positioning using preformed curves, visualization through radiopaque markers, and lead delivery through an integrated lumen. This multi-functionality eliminates the need for multiple separate devices and procedures, reducing overall procedure time and resource consumption despite the increased complexity of individual catheter components
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
This approach enables more precise and efficient implantation of medical electrical leads at the His bundle, reducing procedure duration, hospital resource consumption, and patient radiation exposure, while promoting physiologically correct pacing.
Implementation Method 1
the pull wire, by actuation of the control member, is configured to controllably bend the articulating segment in a first curve in a first geometric plane
Implementation Method 2
the preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane
Implementation Method 3
at least one radiopaque marker on each of the geometric planes... The at least one radiopaque marker and/or at least one electrode array may be used to determine a target implantation location
Implementation Method 4
at least one electrode array to map the His bundle... at least one electrode array configured to sense an electrical signal indicative of a His bundle of a heart of a patient
Data Source
Figure 1A
Figure 1B
Figure 2A
AI summary
An example catheter includes a handle assembly having a control member, an elongate body, a pull wire, and at least one radiopaque marker. The elongate body defines a lumen configured to receive an medical electrical lead including at least one electrode array. The elongate body includes a proximal portion coupled to the handle assembly and a distal portion that includes an articulating segment and a preformed curve segment. The at least one radiopaque marker is positioned on the distal portion. The pull wire extends from the control member and is anchored to the elongate body distal to the articulating segment such that actuation of the control member controllably bends the articulating segment in a first curve in a first geometric plane. The preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane.