Modular Hemostasis Valve Assembly for Wide Catheter Diameter Sealing
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Solution Overview
Problem
Existing hemostasis valve assemblies are limited to a small range of medical material diameters and lack cost-effective solutions for larger diameters, such as those required for transcatheter aortic valve implantation and transaortic mitral valve replacement, necessitating a more adaptable and robust design.
Innovation Solution
A modular hemostasis valve assembly with a modular design comprising a hollow body, distal and proximal seals, a spacer element, and an end cap, allowing for a wide range of inner diameters through exchangeable components, fabricated using standardized production methods and snap-fit connections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If existing hemostasis valve assemblies are designed for specific diameters, then they provide reliable sealing for those specific sizes, but they cannot accommodate a wide range of medical material diameters
Solution Approach 1:
The hemostasis valve assembly is divided into modular components: a reusable hollow body and exchangeable seal assemblies. Each seal assembly includes a distal seal, proximal seal, and spacer element that can be pre-assembled and replaced as a unit. This segmentation allows the same hollow body to accommodate different medical material diameters by simply changing the seal assembly, thereby increasing adaptability without significantly increasing overall device complexity.
Solution Approach 2:
The hollow body is designed as a universal component that can work with multiple seal assemblies of different sizes. The standardized interface between the hollow body and seal assemblies allows a single hollow body design to serve multiple functions across different Fr sizes (e.g., 12 Fr, 14 Fr, 16 Fr, 18 Fr), enabling one component to accommodate a wide range of medical material diameters.
2Reliability
If custom hemostasis valve assemblies are manufactured for each diameter size, then they provide optimal performance for specific applications, but they increase manufacturing costs and reduce cost-effectiveness
Solution Approach 1:
By segmenting the valve assembly into a reusable hollow body and replaceable seal assemblies, the design allows standardization of the expensive-to-manufacture hollow body component while the simpler seal assemblies can be manufactured more economically in various sizes. This reduces overall manufacturing costs compared to producing completely custom assemblies for each diameter.
Solution Approach 2:
The seal assemblies are designed as disposable or limited-life components that can be replaced rather than repaired. This allows the expensive hollow body to be recovered and reused multiple times, while only the less expensive seal assemblies are discarded after use, significantly reducing long-term manufacturing and operational costs.
3Adaptability or versatility
If larger Fr size hemostasis valve assemblies are designed, then they accommodate larger diameter medical material for procedures like TAVI and TAMVR, but they become more expensive and less economically viable
Solution Approach 1:
The separation of the hollow body from the seal assemblies allows the hollow body to be optimized for large diameters once, and then reused with different seal assemblies. This amortizes the high manufacturing cost of large-diameter hollow bodies across multiple procedures and seal assemblies, improving cost-effectiveness for large Fr size applications.
Solution Approach 2:
A single large-diameter hollow body can serve multiple procedures (TAVI, TAMVR, etc.) and work with various seal assemblies of different sizes, making the expensive large-diameter component economically viable by maximizing its utilization across different applications.
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 assembly provides secure sealing and support for a broad range of medical material diameters with low insertion and retraction forces, ensuring effective blood prevention during procedures while being cost-effective and easy to manufacture.
Implementation Method 1
a distal seal arranged at the distal opening of the hollow body and comprising an elastic valve, which is sealed when idle
Data Source
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AI summary
The present invention relates to a hemostasis valve assembly and to a method for assembling a hemostasis valve handle assembly, for instance for a structural heart catheter based delivery system. The hemostasis valve assembly (100) comprises a hollow body (110) delimiting an inner passage for inserting a medical material extending between a proximal opening (104) and a distal opening (102) of the hollow body (110), a distal seal (106) arranged at the distal opening (102) of the hollow body (110) and comprising an elastic valve, which is sealed when idle, a spacer element (112), which is arranged between the distal seal (106) and the proximal seal (108), and an end cap (114), wherein the end cap (114) has fixing means (118) engaging with support means (120) provided at the hollow body (110), so that the stacked assembly comprising the distal seal (106), the spacer element (112), and the proximal seal (108) is fixed inside the hollow body (110).