Hemostatic Valve Circumferential Grooves Seal Leakage
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Solution Overview
Problem
Existing hemostatic valve systems in medical devices often experience leakage and damage when inserting or withdrawing medical interventional devices of varying diameters, due to the inherent design flaws in slitted valves, which lead to incomplete seals and potential tearing of valve disks.
Innovation Solution
A hemostatic valve system comprising a plurality of elastomeric valve members with circular holes, aligned such that each hole is sequentially penetrable by the interventional device and covered by an adjoining member, providing a tight seal and minimizing the risk of damage through the use of offset holes and notched portions for alignment and elasticity to accommodate devices of different sizes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If slitted hemostatic valves are used to enable device passage, then the valve allows interventional devices to pass through, but leakage occurs due to incomplete seals and gap formation
Solution Approach 1:
The patent replaces linear slits with circumferential grooves that extend around the entire perimeter of the valve disk. This curved, continuous groove configuration allows the valve to form a complete seal around the interventional device, eliminating the gap formation that occurs with linear slits. The circumferential grooves conform to the cylindrical shape of the device, ensuring uniform contact and preventing leakage.
Solution Approach 2:
The patent changes the geometric parameters of the valve opening from linear slits to circumferential grooves with specific depth and width dimensions. The grooves are designed with controlled cross-sectional areas that allow them to deform elastically around devices of varying diameters while maintaining seal integrity. This parameter optimization enables both device passage and reliable sealing.
2Adaptability or versatility
If larger slitted valves are used to accommodate larger devices, then device passage is enabled, but valve disk tearing occurs upon insertion
Solution Approach 1:
The patent employs a flexible elastomeric valve disk with circumferential grooves that can elastically deform to accommodate interventional devices of various sizes. The grooves act as stress distribution channels that prevent concentration of forces at specific points, thereby preventing tearing while allowing the valve to flex open for device passage. The material properties and groove geometry are optimized to provide both flexibility and structural integrity.
3Reliability
If multiple valve members are used to reduce leakage, then sealing is improved, but device passage becomes more difficult and additional equipment is required
Solution Approach 1:
The patent segments the sealing function into multiple circumferential grooves on a single valve disk rather than using multiple separate valve members. Each groove provides a portion of the overall seal, and together they create a comprehensive sealing barrier. This segmentation approach maintains reliable leakage control while allowing straightforward device passage through the combined groove structure without requiring additional equipment or complex multi-valve assemblies.
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 system achieves a reliable, leak-free passage of medical devices through the introducer, reducing the risk of valve damage and ensuring effective sealing across a range of device diameters, with improved pressure resistance and ease of use by distributing pressure evenly around the device.
Implementation Method 1
elastomeric hemostatic valves are provided in an attempt to minimize leakage of blood back through the introducer. Such valves are dependent upon the elasticity of the valve body, and its ability to draw back upon itself to seal any gap created upon insertion or withdrawal of a device through the valve
Data Source
AI summary
A medical introducer apparatus for use in inserting an interventional device into a body vessel of a patient. The apparatus includes a housing having a proximal opening, a distal opening, and a chamber positioned between the proximal and distal openings. A sheath, defining a conduit for the interventional device, extends distally from the housing distal opening. A hemostatic valve system is provided in the housing chamber. The valve system includes a plurality of generally elastomeric valve members axially arranged in the chamber. The valve members each have a generally circular hole extending therethrough, which hole is sized for substantially leak-free passage of the interventional device. The valve members are aligned in the chamber to be sequentially penetrable by the interventional device, such that the hole in one valve member is covered by an adjoining valve member.