Inline Introducer Sheath for Low-Profile Heart Valve Delivery
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Solution Overview
Problem
Existing introducer systems for transcatheter medical devices have a large profile that limits their use in patients with smaller vessel sizes, necessitating a smaller profile to minimize vascular trauma and expand the patient population eligible for minimally invasive procedures.
Innovation Solution
A delivery system with an integrated introducer that includes a handle, delivery capsule, and an inner lumen, where the integrated introducer has a smaller inner diameter than the delivery system, allowing for a reduced overall profile and a smooth transition, and features a hemostatic valve and a rigid ring to prevent displacement during delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a traditional introducer system is used, then the delivery system can accommodate standard-sized devices, but the profile is too large for patients with smaller vessel sizes
Solution Approach 1:
The introducer is designed to nest within the delivery system components. The introducer sheath fits inside the delivery catheter, and the entire assembly is contained within the introducer hub, creating a nested configuration that minimizes the overall profile while maintaining all necessary functional components
Solution Approach 2:
The introducer hub integrates multiple functions into a single component: it serves as both the introducer sheath anchor and the delivery system interface. The hemostatic valve is integrated directly into the hub structure, eliminating the need for separate components and reducing the overall profile
2Volume of moving object
If the introducer profile is reduced, then suitability for small-vessel patients improves, but structural stability during delivery may be compromised
Solution Approach 1:
The introducer exhibits different structural qualities at different locations: the distal portion features a rigid tip for stability and positioning, while the proximal portion is more flexible to accommodate the reduced profile. The hub structure provides localized rigidity where needed for stability while maintaining overall compactness
Solution Approach 2:
The introducer is constructed using composite materials that combine rigidity and flexibility in a single structure. The shaft incorporates reinforced sections with higher structural integrity for stability, while other sections use more flexible materials to reduce the overall profile, creating a composite structure that satisfies both requirements
3Object-affected harmful factors
If the introducer profile is minimized, then vascular trauma is reduced, but the hemostatic seal effectiveness may be compromised
Solution Approach 1:
The hemostatic valve utilizes a flexible membrane structure that can deform to create an effective seal within the compact hub. The flexible shell conforms to the internal geometry of the hub, maintaining seal integrity despite the reduced overall size of the introducer assembly
Solution Approach 2:
The hemostatic valve design incorporates parameter optimization where the valve opening size, membrane thickness, and sealing surface area are specifically tuned to achieve effective hemostasis within the minimized profile. The parameters are adjusted to maximize sealing effectiveness while minimizing the space required
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
The integrated introducer reduces the overall diameter of the delivery system, increasing the suitability for patients with smaller vessels and minimizing vascular trauma while maintaining a secure seal and stability during deployment.
Implementation Method 1
a hub having a hemostatic valve to prevent blood loss from the lumen of the introducer sheath
Data Source
Figure 1A~1B
Figure 2~3B
AI summary
Systems and methods for delivering and implanting heart valves are disclosed. The delivery systems (100) can include an integrated introducer (110). The integrated introducer can include a sheath (112) having an inner diameter that is smaller than the outer diameter of a delivery capsule (104) of the delivery system and an outer diameter that is approximately equal to the outer diameter of the delivery capsule. The integrated introducer can include a hub (120) having a hemostatic seal. The hub can have a locking mechanism configured to fix the integrated introducer in place on the delivery system.