Leadless Pacing Device Delivery Catheter with Deflectable Proximal Section
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Solution Overview
Problem
Conventional medical devices, such as leadless cardiac pacemakers, face challenges in secure anchoring within the heart due to dislodgment during heart function, and existing delivery systems lack efficient navigation and control for precise placement.
Innovation Solution
A delivery device with a distal holding section designed to receive a leadless pacing device, featuring a proximal section with deflection mechanisms, a push member, and a deformable distal tip for atraumatic engagement, allowing for precise navigation and anchoring within the heart using conductive pathways for testing and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a leadless pacing device is implanted in the heart, then it provides cardiac pacing function, but it may become dislodged during heart function
Solution Approach 1:
The delivery device is divided into distinct functional sections: a proximal section with deflection mechanisms for navigation, and a distal holding section for device retention. This segmentation allows each section to be optimized for its specific function while working together as an integrated system.
Solution Approach 2:
The distal holding section is pre-configured with a cavity designed to receive and securely hold the leadless pacing device before implantation. This preliminary preparation ensures that the device is properly positioned and anchored before being deployed into the heart.
2Measurement precision
If existing delivery systems are used, then device delivery is possible, but navigation and control for precise placement is insufficient
Solution Approach 1:
The proximal section of the delivery device includes deflection mechanisms that allow dynamic adjustment of the device's orientation and position during navigation. This enables the operator to precisely control the placement of the leadless pacing device within the heart chamber.
Solution Approach 2:
The delivery device incorporates features that provide feedback during the implantation process, allowing the operator to assess device positioning and make real-time adjustments to achieve precise placement.
3Strength
If a rigid delivery system is used, then structural strength is maintained, but tissue trauma increases
Solution Approach 1:
The distal holding section features a deformable distal tip with different mechanical properties than the proximal section. The distal tip is designed to be softer and more compliant to minimize tissue trauma during insertion and deployment, while the proximal section maintains sufficient rigidity for navigation and control.
Solution Approach 2:
The distal tip of the delivery device incorporates flexible or deformable materials that allow the structure to adapt to tissue contours and reduce mechanical stress on surrounding tissues during the implantation process.
Data Source
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AI summary
Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include a proximal section including a deflection mechanism for deflecting the proximal section, and a distal holding section extending distally of a distal end of the proximal section and defining a cavity therein for receiving an implantable leadless pacing device. The delivery device may include more than one deflection mechanism for deflecting the proximal section at multiple deflection regions. The delivery device may include more than one tubular member that are translatable relative to one another, and the one or more tubular members may include fixed curve portions. The delivery device may include an atraumatic or bumper tip at the distal end of the holding section.