Articulating Suture Foot 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, time-consuming, and can lead to complications like hematoma, pseudo-aneurysm formation, and vascular occlusion due to difficulties in accurately placing sutures or fasteners at the vascular puncture site.
Innovation Solution
A device with an articulatable foot and laterally deflecting needles that minimizes tissue tract dilation, allowing for precise placement of sutures across the vascular puncture site, forming a pre-tied knot for secure closure with reduced friction and trauma to the vessel.
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 suture is pre-formed and positioned within the device before insertion. The device is advanced to the puncture site and deployed to secure the suture in place, eliminating the need for prolonged manual compression and accelerating hemostasis achievement
2Reliability
If bioabsorbable fasteners are used for vascular closure, then hemostasis is achieved, but accurate placement is difficult leading to complications
Solution Approach 1:
The device serves as an intermediary delivery system that guides and positions the suture and fastener components precisely at the vascular puncture site. The articulated foot and needle mechanisms enable accurate placement while minimizing tissue trauma
Solution Approach 2:
The device features localized functional elements including an articulated foot for precise positioning, needles for targeted tissue penetration, and a suture delivery mechanism that concentrates the closure action exactly at the puncture site, ensuring accurate placement
3Ease of operation
If a traditional suturing device is used, then suture placement is possible, but the device cross-section causes tissue tract dilation and trauma
Solution Approach 1:
The device is divided into functional segments including a shaft, an articulatable foot, needles, and suture components. This segmentation allows each element to perform its specific function while maintaining a compact overall profile that minimizes tissue tract dilation
Solution Approach 2:
The foot is designed to be articulatable, allowing it to move between a retracted position (minimizing device cross-section and tissue trauma during insertion) and a deployed position (enabling suture placement). This dynamic configuration reduces harmful effects while maintaining operational capability
Data Source
AI summary
Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot of the device can be inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot can carry suturing attachment cuffs with one end of the cuff adapted to receive a needle, while the other end receives suture. A portion of the foot and/or lumen of the shaft can receive a portion of the suture and can include friction reducing structure that aid with movement of the sutured during removal of the cuffs from within the penetration.