Articulating Suturing Device Actuation and Alignment
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Solution Overview
Problem
Current methods for achieving hemostasis after vascular procedures, such as manual compression and bioabsorbable fasteners, are time-consuming, risky, and often result in complications like hematoma, pseudo-aneurysm formation, and vascular occlusion, especially when anticoagulants are used or larger sheaths are employed.
Innovation Solution
A device with an articulatable foot and laterally deflecting needles that form a suture loop across the puncture site, minimizing tissue tract dilation and allowing for pre-tied knot delivery, which enhances ease and speed of vascular closure with reduced trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used for hemostasis, then bleeding is stopped, but the procedure is time-consuming and requires extensive patient observation
Solution Approach 1:
The suture is pre-tied and loaded onto the device shaft before insertion. The needle penetrates the vessel wall and draws the pre-tied suture through, allowing immediate closure without requiring time-consuming on-site knot tying or compression procedures.
Solution Approach 2:
The patent replaces the mechanical compression system with a suturing system that uses a needle and pre-tied suture to mechanically close the vessel puncture site, eliminating the need for prolonged manual compression and subsequent observation periods.
2Reliability
If bioabsorbable fasteners are used for vascular closure, then hemostasis is achieved, but there is risk of vascular occlusion and thrombus formation
Solution Approach 1:
The patent extracts the thrombogenic sealing body from the closure mechanism and replaces it with a suturing system that closes the vessel wall without intruding into the lumen. The suture passes through the vessel wall and is tied outside, eliminating the risk of thrombus formation on intravascular surfaces.
Solution Approach 2:
The needle acts as an intermediary that carries the suture through the vessel wall, allowing closure without direct contact between the closure material and the blood flow path. This mediates the interaction between the closure system and the vascular system, preventing harmful thrombus formation.
3Object-affected harmful factors
If the shaft cross-section is reduced for minimal tissue tract dilation, then trauma is minimized, but needle lateral deflection becomes more difficult
Solution Approach 1:
The patent employs a flexible needle that can dynamically deflect laterally from the shaft axis during penetration. The needle is designed with flexibility to accommodate lateral deflection while maintaining connection to the shaft, allowing minimal cross-section design without compromising needle positioning control.
Solution Approach 2:
The patent addresses the dimensional constraint by allowing the needle to move in a lateral dimension relative to the shaft axis. This lateral deflection capability provides the necessary positioning adjustment within the constrained shaft cross-section, enabling both minimal trauma and operational ease.
4Measurement precision
If multiple repositioning actions are required for device operation, then precise positioning is achieved, but procedure complexity and time increase
Solution Approach 1:
The device incorporates self-aligning features such as alignment markings on the shaft and foot that automatically orient the components relative to each other. The foot can be deployed and positioned without requiring multiple manual repositioning actions, as the device structure itself guides precise alignment during the single insertion and deployment sequence.
Data Source
AI summary
A vessel closure device that includes improved activation and alignment mechanisms that result in greater control and ease of use for the user.