Large-Bore Sheath Coupling for Flexible Vessel Access Alignment
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Solution Overview
Problem
Current sheaths for large bore access in vessels like the femoral artery, axillary artery, and common carotid artery suffer from flexibility issues, unfavorable tip shapes, and lack of axial or radial alignment, leading to vascular trauma, embolic events, and suboptimal deployment of devices such as prosthetic heart valves.
Innovation Solution
A sheath device with a flexible design featuring varying flexibility along its length, including a proximal section with higher stiffness and a distal section with greater flexibility, an atraumatic tip, and a coupling device for secure alignment of delivery devices, along with a sheath hub that supports deairing and fluid management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sheath is designed with uniform flexibility along its length, then manufacturing is simpler, but it cannot provide optimal navigation through tortuous vessels and may cause vascular trauma
Solution Approach 1:
The sheath body is divided into multiple sections with different flexibility characteristics: a proximal section with first flexibility, a distal section with second flexibility greater than the first, and optionally a transition section with intermediate flexibility. This segmentation allows each section to be optimized for its specific function while navigating complex vascular anatomy.
Solution Approach 2:
Different sections of the sheath are assigned different flexibility properties tailored to their functional requirements. The distal section has higher flexibility to navigate tortuous vessels, while the proximal section maintains lower flexibility for stability during device deployment. This local differentiation resolves the contradiction between navigation capability and structural simplicity.
2Reliability
If a sheath has a rigid tip for structural support, then it provides better stability during device delivery, but it causes vascular trauma and embolic events
Solution Approach 1:
The sheath incorporates an atraumatic tip with rounded distal end that is void of support structure, creating a localized soft region at the tip. This allows the tip to be flexible and non-traumatic while the proximal section maintains rigidity for stability, resolving the contradiction between stability and trauma prevention.
Solution Approach 2:
The atraumatic tip design provides pre-cushioning at the distal end of the sheath, preventing direct contact between rigid structures and vascular tissue before potential trauma can occur. This protective feature is built into the sheath structure itself to prevent embolic events and vascular injury.
3Adaptability or versatility
If a sheath is designed for percutaneous femoral access, then it works well for that specific application, but it has unfavorable flexibility profiles and tip shapes for other vessels like carotid or axillary arteries
Solution Approach 1:
The sheath is designed with a multi-section flexibility profile and atraumatic tip that can be optimized for different vessel types (femoral, carotid, axillary). This universal design allows a single sheath structure to adapt to various access sites and vessel anatomies, improving versatility without requiring multiple specialized sheath designs.
Solution Approach 2:
The sheath incorporates dynamic flexibility characteristics through its multi-section construction, allowing it to adapt its bending and conformability based on the specific vessel anatomy encountered. This dynamic response enables the sheath to optimize its performance for different vessels while maintaining structural integrity.
4Manufacturing precision
If a delivery system lacks alignment features, then the device structure is simpler, but it cannot achieve proper axial and radial alignment for device deployment
Solution Approach 1:
The coupling device acts as an intermediary component between the delivery system and the sheath, providing axial and radial alignment features. This separate alignment mechanism can be integrated into existing delivery systems without fundamentally redesigning the entire device, achieving precision alignment while managing complexity through modular addition.
Data Source
AI summary
Various embodiments of a sheath device and related methods are described herein. In some embodiments, the sheath device can include a sheath hub and a sheath body extending from the sheath hub. The sheath body can include an inner passageway and a proximal section having a first length and a first flexibility along the first length. The sheath body can further include a distal section having a second length and a second flexibility along the second length, and the second flexibility can be greater than the first flexibility. The sheath body can further include an atraumatic tip positioned at a distal end of the sheath body, and the atraumatic tip can include a rounded distal end.