Needle Removal Device for Secure Extraction
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Solution Overview
Problem
Current methods for achieving hemostasis after vascular procedures, such as manual compression and bioabsorbable sealing bodies, are inefficient, uncomfortable for patients, and prone to complications like bleeding and thrombosis, especially when using larger sheaths or anticoagulants, and existing suture applying devices struggle with efficiently removing needles from the suturing system.
Innovation Solution
A needle removal device with a base member and needle receptacles that can be positioned adjacent to the suturing system, allowing for the secure grasping and removal of needles from the system, reducing the force required for extraction and minimizing complications.
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 patent extracts the hemostasis function from manual compression by introducing a self-expanding closure device that autonomously achieves vessel closure. The device is deployed at the puncture site and automatically expands to occlude the vessel, eliminating the need for prolonged manual compression and reducing patient recumbency time while maintaining reliable hemostasis.
Solution Approach 2:
The closure device is designed to be self-expanding and self-positioning once deployed. It automatically expands to the correct size and shape to occlude the vessel without requiring continuous manual intervention. The device performs the hemostasis function autonomously, freeing the patient from prolonged recumbency while ensuring reliable bleeding cessation.
2Adaptability or versatility
If larger introducer sheaths are used for vascular access, then better catheter delivery is achieved, but the risk of complications during manual compression increases
Solution Approach 1:
The patent removes the dependency on manual compression for achieving hemostasis in large-bore access. By deploying a self-expanding closure device that independently occludes the vessel, the system eliminates the harmful effects associated with manual compression of large puncture sites, such as vessel occlusion, ischemia, and thrombosis, while preserving the ability to use large introducer sheaths for catheter delivery.
Solution Approach 2:
The self-expanding closure device acts as an intermediary between the large puncture site and the vessel lumen. It provides a controlled, gradual occlusion mechanism that prevents the complications associated with direct manual compression of large vessels, mediating the closure process to ensure safety while maintaining the benefits of large-bore access.
3Reliability
If bioabsorbable sealing bodies are used to achieve hemostasis, then bleeding is controlled, but the sealing bodies may wander or move out of position causing late bleeds
Solution Approach 1:
The closure device is segmented into multiple functional components: an expandable frame structure, radial struts, and attachment mechanisms. This segmentation provides multiple points of contact and anchoring with the vessel wall, distributing the securing force and preventing the device from wandering or migrating, thereby maintaining stable positioning while controlling bleeding.
Solution Approach 2:
The device is designed to be deployed in a constrained state and then self-expand to its functional configuration. This preliminary action of controlled expansion ensures that the device assumes its stable, anchored position immediately upon deployment, preventing migration or wandering that could lead to late bleeding complications.
4Reliability
If excessive pressure is applied during manual compression, then hemostasis is achieved, but vessel occlusion and thrombosis occur
Solution Approach 1:
The closure device provides dynamic, adjustable compression through its self-expanding frame structure. The radial struts can be positioned to apply controlled pressure at multiple points around the puncture site, distributing the force evenly and preventing excessive localized pressure that would cause vessel occlusion or thrombosis while still achieving effective hemostasis.
Solution Approach 2:
The device incorporates flexible radial struts and a conformable frame structure that adapt to the vessel geometry. These flexible components distribute compression forces uniformly across the puncture site, preventing concentrated excessive pressure that could lead to vessel occlusion or thrombosis while maintaining effective hemostasis control.
Data Source
AI summary
A medical device including an elongate member extending from a proximal end toward a distal end, the elongate member having a lumen with a longitudinal axis, a hub portion towards the proximal end of the elongate member and configured for a user to hold and manipulate a position of the elongate member, a base portion including a first groove and a second groove separated by an opening, and two wings disposed towards a distal end of the medical device, the two wings being opposite each other across the longitudinal axis and on opposite sides of the base portion, wherein, the two wings are configured to move in relation to the longitudinal axis and wherein each wing has an elongate slot having a closed first end at a location between the base portion and a peripheral end of the wing.