Over-the-Wire Delivery Shuttle for Smaller-Profile Implantation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The implantation of medical devices like leadless pacemakers is challenging due to the large outer diameter of conventional dilator/introducer systems, which can cause difficulty in navigating through distorted or tortuous patient vasculature and increase the risk of vascular damage.
Innovation Solution
A shuttle apparatus is introduced that replaces the dilator/introducer system, comprising a semiconical introducer member and a frustoconical plug member, allowing for over-the-wire implantation with a reduced outside diameter and enhanced flexibility, featuring a collar member for guidewire engagement and a cantilevered arm for easy extraction.
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 are improved, but the ease of navigation through patient vasculature deteriorates and the risk of vascular damage increases
Solution Approach 1:
The delivery system is divided into separate functional components: a flexible catheter for navigation, a dilator for vascular access, and an introducer for device delivery. This segmentation allows each component to be optimized independently - the catheter can be highly flexible for navigation while the dilator provides structural strength when needed.
Solution Approach 2:
The system transitions from a static, rigid dilator/introducer structure to a dynamic, flexible catheter-based system. The catheter can be advanced through tortuous vasculature due to its flexibility, then a rigid dilator can be deployed over it when vascular access is needed, providing structural strength only when required.
2Stability of the object's composition
If a conventional dilator/introducer system with large outer diameter is used, then the structural stability is improved, but the risk of vascular damage increases
Solution Approach 1:
A flexible catheter is advanced through the vasculature first to establish a stable pathway and position. This preliminary action allows the system to navigate tortuous vessels without causing damage, and provides a safe track for subsequent device delivery through the same catheter.
Solution Approach 2:
The flexible catheter acts as an intermediary between the operator and the target site. It can be advanced through distorted vasculature without causing damage, and serves as a protective conduit for delivering the medical device, reducing direct trauma to the vascular wall.
3Ease of operation
If a small outer diameter system is used, then the ease of navigation through patient vasculature is improved, but the structural strength and stability deteriorate
Solution Approach 1:
The system separates navigation functions (flexible catheter) from delivery functions (introducer with dilator). The flexible catheter maintains small diameter for easy navigation, while the introducer provides structural strength when the device needs to be delivered through the vascular system.
Solution Approach 2:
The system dynamically adjusts its structural properties based on the operational phase. During navigation, the flexible catheter provides ease of maneuverability with minimal diameter. During delivery, the introducer is advanced over the catheter to provide the necessary structural strength and stability.
4Productivity
If a conventional dilator/introducer system is used, then the device delivery capability is improved, but the device complexity increases
Solution Approach 1:
The delivery system is segmented into distinct functional components: a flexible catheter for navigation and positioning, a dilator for creating vascular access, and an introducer for device delivery. This segmentation allows each component to perform its specific function efficiently while reducing overall system complexity compared to integrated conventional systems.
Solution Approach 2:
The dilator is designed to be inserted over the flexible catheter, and the introducer is inserted over the dilator, creating a nested configuration. This nesting allows all components to be delivered through a single vascular access point while maintaining their individual functions, simplifying the delivery process.
Data Source
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.