Hemostatic Valve Seal Using Shape Memory Polymer Phase Transition
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Solution Overview
Problem
Current hemostatic valve systems in medical introducers often fail to provide a reliable seal, leading to leakage of body fluids during the insertion and removal of medical devices, and can cause damage to delicate devices due to their design and material properties.
Innovation Solution
The introduction of a hemostatic valve system using shape memory polymers with distinct phase transition temperatures, which self-configures from a temporary opening configuration at room temperature to a sealed configuration above a specific temperature, reducing fluid leakage and minimizing device damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional elastomeric valve members with center holes are used, then device passage is enabled, but fluid leakage occurs when devices are removed due to incomplete retraction of the hole
Solution Approach 1:
The patent changes the material parameter from traditional elastomer to shape memory polymer, which exhibits temperature-dependent shape transformation. The valve member transitions from an open configuration at room temperature (allowing device passage) to a closed configuration at body temperature (providing reliable sealing), thus resolving the contradiction between ease of operation and seal integrity
Solution Approach 2:
The patent utilizes the phase transition properties of shape memory polymers, which undergo a reversible shape change at specific transition temperatures. The valve member is designed to be in an austenitic phase at body temperature (closed state for sealing) and transforms to a martensitic phase at room temperature (open state for device passage), eliminating fluid leakage while maintaining operational ease
2Ease of operation
If larger hole opening valves are utilized to facilitate device insertion, then device passage is improved, but valve disk tearing occurs beyond the hole upon insertion
Solution Approach 1:
The patent changes the material parameters of the valve member from traditional elastomer to shape memory polymer with enhanced mechanical properties. This material can be engineered to have greater tensile strength and elasticity, allowing larger opening configurations that facilitate device insertion without risking disk tearing or structural failure during the insertion process
3Reliability
If smaller hole opening valves are utilized to improve sealing, then fluid leakage is reduced, but device insertion becomes difficult and device damage may occur
Solution Approach 1:
The patent employs phase transition of shape memory polymer to create a temperature-dependent opening mechanism. At room temperature, the valve member is in a martensitic phase with a large opening that facilitates easy device insertion. Upon contact with body temperature, it transforms to an austenitic phase with a closed configuration that provides excellent sealing, thus resolving the contradiction between seal performance and ease of insertion
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 use of shape memory polymers in the hemostatic valve system ensures a leak-free passage of medical devices and reduces the risk of device damage by effectively sealing the opening when heated, enhancing the overall efficiency and reliability of medical device insertion and removal processes.
Implementation Method 1
The seal is formed of shape memory polymers and has a first phase transition temperature, which is higher than about body temperature, and a second phase transition temperature, which is less than the first phase transition temperature but is greater than about room temperature
Implementation Method 2
When at a temperature of at least the second phase transition temperature, the seal self-configures to a second configuration for obstructing body fluid from flowing through the opening of the seal
Data Source
AI summary
In at least one embodiment of the present invention, an introducer for use in inserting a medical device into a body vessel of a patient is provided. The introducer comprises a housing having a proximal opening, a distal opening and a chamber extending therebetween. A seal in diaphragm form is disposed in the chamber. The seal is formed of polymeric material having a first phase transition temperature higher than about body temperature and a second phase transition temperature that is less than the first phase transition temperature but is greater than about room temperature. The seal is in a first configuration and has an opening formed therethrough when at about room temperature for advancing the medical device through the seal. The seal self-configures to a second configuration when at a temperature of at least the second phase transition temperature for obstructing the body fluid from flowing through the opening of the seal.