Articulating Suture Device for Vascular Puncture Closure
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Solution Overview
Problem
Current methods for achieving hemostasis after vascular procedures, such as manual compression and bioabsorbable fasteners, are inefficient, risky, and prone to complications like hematoma, pseudoaneurysm formation, and vascular occlusion, especially in larger sheath sizes and anticoagulated patients.
Innovation Solution
A tissue closure device with a shaft and hingedly attached arms that deploy laterally to facilitate the placement of sutures through the vascular wall, allowing for secure closure of vascular punctures with pre-tied knots, reducing tissue trauma and procedural time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to achieve hemostasis, then bleeding is stopped, but the procedure is time-consuming and requires prolonged patient recumbency
Solution Approach 1:
The device divides the hemostasis function into separate components: an introducer sheath for access, a closure device with deployable arms for mechanical closure, and a suture system for secure attachment. This segmentation allows each component to perform its specific function efficiently, eliminating the need for prolonged manual compression while achieving reliable hemostasis
Solution Approach 2:
The closure device is self-actuating through a pull-wire mechanism that automatically deploys the arms and tensions the suture when the introducer sheath is removed. This self-service mechanism eliminates the need for continuous manual compression and prolonged patient observation, reducing procedural time while maintaining hemostasis reliability
2Reliability
If manual compression is applied to stop bleeding, then hemostasis is achieved, but patient comfort deteriorates and analgesics are frequently required
Solution Approach 1:
The device automatically performs the hemostasis function through its self-actuating mechanism, eliminating the need for manual compression that causes patient discomfort. The device serves itself by deploying its closure mechanism and tensioning the suture without requiring external manual pressure, thereby improving patient comfort while maintaining hemostasis reliability
Solution Approach 2:
The invention replaces the manual mechanical compression system with an automated mechanical closure system. Instead of applying external compressive force through manual pressure, the device uses an internal mechanical mechanism with deployable arms and pre-tied knots to achieve closure, eliminating the discomfort associated with manual compression
3Reliability
If excessive compression pressure is applied to ensure hemostasis, then bleeding is stopped, but vascular occlusion and thrombosis may occur
Solution Approach 1:
The closure device automatically achieves hemostasis through its self-actuating mechanism, eliminating the need for excessive compression pressure. The device self-regulates the closure force through its mechanical design, achieving reliable hemostasis without applying harmful excessive pressure that could cause vascular occlusion or thrombosis
Solution Approach 2:
The invention changes the pressure parameter from high compression force to controlled mechanical closure force. Instead of applying excessive compression pressure, the device uses a controlled mechanical mechanism with pre-tied knots and deployable arms to achieve hemostasis at appropriate pressure levels, eliminating the risk of vascular occlusion and thrombosis
4Reliability
If bioabsorbable fasteners are used to stop bleeding, then hemostasis is achieved, but the risk of hematoma and pseudoaneurysm formation increases
Solution Approach 1:
The device segments the closure function into separate components: deployable arms that position the closure mechanism precisely at the puncture site, and pre-tied knots that secure the suture. This segmentation allows for controlled mechanical closure without the need for bioabsorbable fasteners, reducing the risk of hematoma and pseudoaneurysm formation while achieving reliable hemostasis
Solution Approach 2:
The invention uses a disposable closure device with pre-tied knots and deployable arms that performs the hemostasis function and is then removed. This single-use mechanical system replaces bioabsorbable fasteners, achieving reliable hemostasis without the complications of hematoma and pseudoaneurysm formation associated with bioabsorbable materials
Data Source
AI summary
A method and apparatus for positioning a locator. The method includes inserting a tissue locator through an opening in a tissue wall, and advancing an engagement member to move a portion of the first arm from a first position to a second position that is separated from a longitudinal axis of the tissue locator by a greater distance than the first position.