Shuttle Introducer for Over-the-Wire Implant Navigation
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Solution Overview
Problem
The large outer diameter of conventional dilator/introducer systems used for implanting medical devices like leadless pacemakers can make navigation through patient vasculature difficult, especially in cases of distorted or tortuous vessels, increasing the risk of vascular damage and limiting the use of over-the-wire implantation procedures.
Innovation Solution
A shuttle apparatus that replaces the dilator/introducer system, comprising a tapered semiconical introducer member and a frustoconical plug member, which engages a delivery catheter to reduce the overall diameter and facilitate navigation, allowing for over-the-wire implantation of medical devices by releasably engaging a container on the delivery catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a conventional dilator/introducer system with large outer diameter is used, then the structural strength and stability of the implantation system is improved, but the ease of navigation through patient vasculature deteriorates and vascular damage risk increases
Solution Approach 1:
The implantation system is divided into separate functional components: a guidewire for navigation, a delivery catheter for device transport, and a delivery cup for device deployment. This segmentation allows each component to be optimized independently - the guidewire can be thin and flexible for navigation, while the delivery cup provides structural support for device deployment, eliminating the need for a single large-diameter rigid structure.
Solution Approach 2:
The delivery cup is positioned within the delivery catheter, which in turn is positioned over the guidewire. This nested arrangement allows the system to achieve the necessary structural strength at the delivery cup while maintaining a small outer diameter at the guidewire interface, enabling easy navigation through vasculature without requiring a large external diameter throughout the entire system.
2Stability of the object's composition
If a dilator/introducer system with large outer diameter is used, then the stability of the implantation system is improved, but the risk of vascular damage increases
Solution Approach 1:
By separating the stability function (delivery cup) from the navigation function (guidewire and delivery catheter), the system maintains stability where needed for device deployment while using thin, flexible components for vascular navigation, thereby minimizing vascular damage risk.
Solution Approach 2:
The delivery catheter acts as an intermediary between the guidewire and the delivery cup, providing a flexible yet structurally adequate pathway that protects the vasculature from direct contact with rigid structures while maintaining system stability for successful device implantation.
3Ease of operation
If a dilator/introducer system is used for over-the-wire implantation, then the ability to navigate through vessels is improved, but the overall device complexity increases
Solution Approach 1:
The system is segmented into three distinct components (guidewire, delivery catheter, delivery cup) with specific functions, replacing the complex integrated dilator/introducer system. This segmentation simplifies the overall design by eliminating unnecessary components while maintaining navigation capability through the specialized guidewire and delivery catheter assembly.
Data Source
Figure 1
Figure 2A~2G
Figure 3A~3D
AI summary
A shuttle apparatus configured to detachably engage a delivery system for an implantable medical device. The shuttle apparatus includes a distal portion having a generally semiconical introducer member with a proximal base and a distal apex, a proximal portion having a hollow, generally frustoconical plug member with a base adjacent to the base of the introducer member, and a collar member with a distal end on the introducer member and a proximal end on the plug member, wherein the proximal end of the collar member includes a cantilevered arm.