Telescopic Hub Delivery Device for Leadless Pacemaker
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Solution Overview
Problem
Current medical devices for delivering leadless cardiac pacemakers face challenges in navigating tortuous anatomy and ensuring precise placement without causing tissue trauma, and there is a need for improved delivery systems that facilitate easier navigation and control during deployment.
Innovation Solution
A delivery device with a multi-stage deployment mechanism, including a telescoping arrangement of hub portions and a locking mechanism, allows for precise control and navigation through the vasculature, featuring a softer distal tip and articulation mechanisms for atraumatic delivery and secure anchoring of the pacemaker.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a delivery device is designed to navigate tortuous anatomy, then navigation capability is improved, but device complexity increases
Solution Approach 1:
The delivery device is divided into multiple hub portions (first hub portion, second hub portion, third hub portion) that can move relative to each other along the longitudinal axis. This segmentation allows each segment to perform specific functions (navigation, deployment, anchoring) independently, improving adaptability while managing overall device complexity through modular design
Solution Approach 2:
The hub portions are designed to be dynamically movable relative to one another through the multi-stage deployment mechanism. The ability to extend and retract hub portions allows the device to adapt its configuration during navigation and deployment, enhancing versatility without requiring a completely complex fixed structure
2Manufacturing precision
If a multi-stage deployment mechanism is implemented, then deployment precision is improved, but device complexity increases
Solution Approach 1:
The deployment process is segmented into multiple distinct stages controlled by separate mechanisms (first multi-stage deployment mechanism for hub portions, second multi-stage deployment mechanism for anchoring). This segmentation allows each stage to be precisely controlled independently, achieving high deployment precision while organizing complexity into manageable functional modules
Solution Approach 2:
The hub portions and anchoring features are pre-configured in a compressed delivery state within the delivery device. The multi-stage mechanisms enable preliminary positioning and preparation before final deployment, ensuring precision by establishing correct configurations in advance rather than relying on single-step actions
3Object-affected harmful factors
If a softer distal tip is used, then tissue trauma is reduced, but device strength is worsened
Solution Approach 1:
The delivery device employs different material properties at different locations: the distal tip is made of softer material to minimize tissue trauma during navigation and deployment, while proximal portions maintain stronger, more rigid materials to provide structural support and force transmission. This local differentiation of material quality resolves the contradiction between softness for tissue protection and strength for device functionality
4Reliability
If a locking mechanism is added, then anchoring security is improved, but device complexity increases
Solution Approach 1:
The locking mechanism is nested within the multi-stage deployment mechanism structure. The anchoring features are integrated into the hub portions that are already part of the deployment system. This nesting approach allows the locking function to be achieved without adding completely separate external mechanisms, thereby improving anchoring security while minimizing the increase in overall device complexity
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 an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may further include a handle assembly including at least an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member and a proximal hub portion affixed adjacent to the proximal end of the inner tubular member. A longitudinally extending groove having a proximal end and a distal end may be disposed in the intermediate hub portion. A first locking mechanism may be configured to releasably couple the intermediate hub portion and the proximal hub portion.