Anastomotic Device with Shape Memory Alloy Connector
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Solution Overview
Problem
Current anastomotic techniques face challenges in securely connecting synthetic grafts to vessels with significant calcium deposition or friable tissue, leading to sub-optimal anastomosis and increased blood loss during major open-heart surgeries.
Innovation Solution
A vascular connector system comprising a tubular sleeve graft with a semi-rigid cylindrical connector body and a compressive band, which includes expandable designs and grooves for secure placement, allowing for a rapid and stable attachment to the native vessel, reducing the need for excessive tension and minimizing bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a running suture technique is used to connect synthetic graft to native vessel, then the anastomosis can be completed with standard surgical tools, but the connection is sub-optimal when vessel tissue has calcium deposition or is friable, leading to increased blood loss
Solution Approach 1:
The patent introduces a specialized anastomotic device as an intermediary component between the synthetic graft and native vessel. This device includes a proximal portion that interfaces with the graft and a distal portion that interfaces with the native vessel, providing a reliable connection mechanism that overcomes the limitations of direct suture attachment to compromised vessel tissue.
Solution Approach 2:
The anastomotic device utilizes shape memory alloy materials that change their mechanical properties in response to temperature changes. The device transitions from a compressed low-profile state during insertion to an expanded stable state upon heating in the body, enabling reliable attachment without requiring excessive tension on friable or calcified vessel tissue.
2Stability of the object's composition
If excessive tension is applied during anastomosis to ensure secure connection, then the connection stability improves, but tissue damage increases and blood loss worsens
Solution Approach 1:
The anastomotic device incorporates dynamic elements including shape memory alloy components that actively change their configuration in response to environmental conditions. The device transitions from a flexible compressed state during insertion to a rigid expanded state after deployment, providing stability without requiring excessive tension on the native vessel tissue.
Solution Approach 2:
The device is divided into multiple functional segments: a proximal portion for graft attachment, a distal portion for native vessel attachment, and intermediate connection elements. This segmentation allows each portion to be optimized for its specific function and enables the device to achieve stable attachment through distributed forces rather than concentrated tension on the vessel wall.
3Device complexity
If traditional running suture method is used, then the surgical procedure uses simple tools and techniques, but the surgical time increases and productivity decreases
Solution Approach 1:
The anastomotic device combines multiple functions into a single integrated component: it provides structural support, creates the anastomotic connection, and ensures hemostasis. This merging of functions into one device reduces the number of separate surgical steps and tools required, thereby improving surgical efficiency without significantly increasing overall procedural complexity.
4Strength
If the connector body is made rigid to provide structural support, then the connection strength improves, but the ability to navigate through the vessel and expand at the target site decreases
Solution Approach 1:
The connector body utilizes shape memory alloy materials that undergo parameter changes in response to temperature. During insertion, the device maintains a flexible compressed state that allows easy navigation through the vessel. Upon reaching the target site and exposure to body temperature, the material undergoes a phase transition to become rigid, providing the necessary structural strength for stable attachment.
Solution Approach 2:
The connector transitions from a static compressed configuration during delivery to a dynamic expanded configuration at the implantation site. This dynamic transformation allows the device to adapt its mechanical properties to the different requirements of each phase: flexibility during navigation and rigidity during function.
Data Source
AI summary
A vascular connector includes a tubular sleeve graft having a first layer and a second layer and a cylindrical connector body positioned within the tubular sleeve graft between the first layer and the second layer. The cylindrical connector body is more rigid than the tubular sleeve graft and is configured to slide longitudinally within the tubular sleeve graft between the first layer and the second layer.