Guide Sheath Seal Stack for Non-Coaxial Hemostasis
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Solution Overview
Problem
Existing guide sheath assemblies in medical devices face challenges in preventing blood loss during insertion and withdrawal, particularly when non-coaxial insertion paths are used, leading to potential hemostasis loss and increased risk of cardiogenic shock.
Innovation Solution
A seal stack for a guide sheath assembly comprising a cross-plane seal with perpendicular slits and cutouts, a self-centering seal with flexible curves, a funnel seal for visual guidance, a cinched seal for centering, and a collapsible seal for expansion and retraction, which collectively provide effective sealing and retention of medical devices during insertion and withdrawal, regardless of alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional seal design is used in guide sheath assembly, then the structure is simple, but hemostasis loss occurs during non-coaxial insertion
Solution Approach 1:
The seal is divided into multiple functional segments including a cross-plane seal with perpendicular slits, a self-centering seal with radial curves, and a collapsible seal. Each segment performs a specific function: the cross-plane seal prevents hemostasis loss, the self-centering seal guides non-coaxial insertion, and the collapsible seal adapts to device passage. This segmentation allows the complex seal structure to effectively address hemostasis prevention while managing the complexity through functional specialization.
Solution Approach 2:
The seal components are nested within each other in a layered configuration. The cross-plane seal is positioned distally, with the self-centering seal intermediate, and the collapsible seal proximally. This nested arrangement allows each seal component to work in sequence during insertion and withdrawal, with the outer guide sheath containing all seal elements. The nesting principle enables multiple sealing functions within a compact structure, improving hemostasis prevention without excessive complexity.
2Adaptability or versatility
If a seal stack is designed to handle both coaxial and non-coaxial insertions, then hemostasis prevention is improved, but the device complexity increases
Solution Approach 1:
The self-centering seal incorporates asymmetric radial curves that are strategically positioned to guide non-coaxial insertion paths. These curves create asymmetric forces that naturally center the medical device during insertion, accommodating both coaxial and non-coaxial approaches. The asymmetric design allows the seal to adapt to varying insertion angles while maintaining hemostasis, enhancing versatility without requiring completely separate sealing mechanisms for different insertion types.
Solution Approach 2:
The collapsible seal is designed to dynamically change its configuration during device passage. It can collapse to accommodate the medical device during insertion and withdrawal, then return to its original sealing configuration. This dynamic behavior allows the seal stack to adapt to both coaxial and non-coaxial insertions, as well as different device sizes and shapes, while maintaining hemostasis prevention. The dynamic特性 reduces the need for multiple static sealing structures, managing complexity through functional adaptability.
3Reliability
If multiple seal components are used in the seal stack, then sealing effectiveness is improved, but manufacturing complexity increases
Solution Approach 1:
Each seal component is designed with multi-functionality to reduce the overall number of parts needed. The cross-plane seal not only prevents hemostasis but also provides structural support for the other seal components. The self-centering seal simultaneously guides device insertion and maintains sealing. The collapsible seal both accommodates device passage and restores hemostasis. This multi-functionality reduces manufacturing complexity by eliminating the need for separate components for each function, while still achieving effective sealing through the combination of specialized components.
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 seal stack minimizes hemostasis loss by maintaining seals during both coaxial and non-coaxial insertions, reducing the risk of blood loss and transfusions, and enhancing procedural success with a variety of medical devices.
Implementation Method 1
a flexible membrane connected to the first ring and the second ring
Implementation Method 2
The disc includes a plurality of raised curves extending axially from the distal end of the self-centering seal to the proximal end of the self-centering seal
Data Source
AI summary
A cross-plane seal having a distal end and a proximal end includes a disc at the distal end. The disc includes a distal face at a distal side, a proximal face at a proximal side, a plurality of cut outs in the distal face forming a raised X-shape on the distal face, a first slit having a partial through-cut into the distal face and aligned with a first leg of the raised X-shape, the through-cut extending more than halfway through the thickness of the disc, a second slit having a partial through-cut into the proximal face and aligned with a second leg of the raised X-shape, the through-cut extending more than halfway through the thickness of the disc, and an intersection formed by the first slit and the second slit. An annular portion is connected to and extends proximally away from the disc.