Vascular Closure Device Balloon and Suture Mechanism
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Solution Overview
Problem
Current methods for achieving hemostasis after vascular procedures, such as manual compression, are time-consuming, uncomfortable for patients, and associated with risks like ischemia, thrombosis, and increased complications, especially in anticoagulated patients or with larger introducer sheaths.
Innovation Solution
A closure device comprising an elongate member with needle lumens and a closure element with a foot portion and needle guide portion, which can be deployed to facilitate suturing of the puncture site by guiding needles through the vessel wall and attaching sutures to cuffs, thereby securing the closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If manual compression is used for hemostasis, then the procedure can be performed with simple equipment, but the procedure is time-consuming and requires prolonged patient recumbency
Solution Approach 1:
The patent replaces the manual compression mechanical system with an automated closure device that uses a balloon catheter and suturing mechanism. The device automatically secures the puncture site through balloon inflation and suture attachment, eliminating the need for prolonged manual compression and extended recumbency periods while maintaining hemostasis effectiveness.
Solution Approach 2:
The closure device performs hemostasis through self-contained mechanisms including self-inflating balloons and automated suture attachment. The device independently achieves closure without requiring continuous external compression force or prolonged patient positioning, thereby reducing the time loss associated with manual compression methods.
2Ease of manufacture
If manual compression is used for hemostasis, then no specialized equipment is needed, but the procedure is uncomfortable for patients and may require analgesics
Solution Approach 1:
The patent substitutes the uncomfortable manual compression mechanism with a minimally invasive closure device that uses balloon inflation and suturing. This replacement significantly improves patient comfort by eliminating the need for prolonged pressure application and associated analgesic requirements, while the device itself remains a relatively simple mechanical system.
3Adaptability or versatility
If manual compression is used for hemostasis, then the procedure can be performed anywhere, but excessive pressure can occlude the blood vessel causing ischemia and thrombosis
Solution Approach 1:
The patent replaces the uncontrolled manual compression system with a precision-controlled closure device featuring a balloon catheter and suturing mechanism. This substitution maintains the procedural portability while dramatically reducing the risk of vascular occlusion, ischemia, and thrombosis through controlled, distributed pressure application that prevents excessive force on the vessel wall.
Solution Approach 2:
The closure device controls pressure parameters through balloon inflation to achieve uniform, distributed compression rather than excessive localized pressure. This parameter control maintains the ability to perform the procedure in various locations while preventing the harmful effects of over-compression such as vessel occlusion and thrombus formation.
4Adaptability or versatility
If the size of the introducer sheath is increased, then more complex procedures can be performed, but the incidence of complications from manual compression increases
Solution Approach 1:
The patent replaces the manual compression system with a closure device specifically designed to handle larger puncture sites from bigger introducer sheaths. The device uses balloon inflation and suturing mechanisms that provide reliable hemostasis even at larger vessel access points, thereby maintaining procedure versatility while reducing complication risks associated with manual compression of larger sites.
Data Source
AI summary
A device for positioning suture through tissue, the device including a proximal elongate member having a longitudinal axis, the proximal elongate member being configured to receive a needle, and a tissue locator disposed distal the proximal elongate member, the tissue locator being coupled to an elongate member extending through the proximal elongate member and including a leg with a needle receiving opening configured to accommodate the needle. Proximal movement of the elongate member compresses the tissue locator and folds the leg of the tissue locator, the leg transitioning from extending longitudinally to extending outwardly in relation to a position of the leg in a pre-compressed state.


