Deployment-Constraining Sheath for Staged Expandable Device Release
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Solution Overview
Problem
Existing methods for creating anastomoses between tissue structures, such as in coronary artery bypass graft surgery, often rely on suturing, which can be cumbersome and prone to misdeployment or failure, particularly when deploying expandable medical devices endoscopically.
Innovation Solution
An expandable medical device with a first and second constraining mechanism that allows staged deployment, where the first mechanism releases the flanges to a deployed configuration while the second mechanism maintains the intermediate portion in an intermediate configuration, ensuring controlled expansion and secure connection between tissue structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suturing is used to create anastomoses, then the connection between tissue structures can be established, but the procedure becomes cumbersome and prone to misdeployment or failure
Solution Approach 1:
The patent replaces the manual suturing mechanical system with a self-expanding medical device system that uses elastic memory alloys to automatically expand and secure tissue connections, eliminating the need for complex manual suturing operations while improving deployment reliability
Solution Approach 2:
The self-expanding device utilizes the elastic memory properties of the alloy material to automatically expand to its predetermined shape upon deployment, without requiring external manipulation or complex deployment mechanisms, thereby simplifying the operational process while ensuring reliable tissue connection
2Ease of operation
If an expandable medical device is deployed endoscopically, then the procedure can be performed minimally invasively, but control over deployment timing and positioning becomes difficult
Solution Approach 1:
The device is pre-formed with a specific expanded shape and dimensions during manufacturing, so that when deployed, it automatically assumes the correct configuration for precise tissue connection without requiring complex real-time adjustment mechanisms during the minimally invasive procedure
Solution Approach 2:
The device exploits the temperature-dependent phase transformation properties of elastic memory alloys, where the material transitions between austenite and martensite phases to enable controlled expansion and locking at specific temperatures, ensuring precise deployment positioning during endoscopic procedures
3Strength
If a self-expanding framework is used to facilitate secure connection, then the connection strength is improved, but the risk of premature expansion or misdeployment increases
Solution Approach 1:
The device is divided into distinct functional segments including the self-expanding framework, covering material, and attachment mechanisms, allowing the framework to provide connection strength while other segments control the deployment timing and prevent premature expansion through constrained delivery catheter integration
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
Facilitates secure and controlled deployment of medical devices, reducing the risk of misdeployment and ensuring a stable, durable connection between tissue structures, thereby enhancing the effectiveness of anastomotic procedures.
Implementation Method 1
The framework is formed from an elastic memory alloy that is radiopaque and that transforms from an austenite phase to a martensite phase in response to a decrease in temperature
Implementation Method 2
The framework is formed from an elastic memory alloy that self-expands to a larger diameter configuration
Data Source
Figure 1
Figure 2
AI summary
Various aspects of the present disclosure are directed toward medical devices, systems, and methods. The medical devices may include a portion having a radially expansive force greater than a radially expansive force other portions of the device. In addition, the medical device may include one or more constraining mechanisms for deployment of the medical devices.