Suturing Device Split Arms 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, uncomfortable for patients, and prone to complications like hematoma and pseudoaneurysm formation, especially when large sheaths are used or patients are anticoagulated.
Innovation Solution
A suturing device with deployable arms that can be positioned at non-perpendicular angles to the shaft, allowing for precise placement of needles and a pre-tied knot, minimizing tissue damage and ensuring effective closure of vascular punctures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to achieve hemostasis, then bleeding can be stopped, but the procedure is time-consuming and requires prolonged patient observation
Solution Approach 1:
The device segments the hemostasis function into distinct components: a puncture closure element for sealing the vessel and a suture element for reinforcing closure. This segmentation allows each component to perform its specific function efficiently, achieving reliable hemostasis without the prolonged compression time required by manual methods
Solution Approach 2:
The device performs preliminary action by pre-positioning the closure element and suture within the introducer sheath before vascular access is established. The closure element is already prepared at the puncture site, eliminating the need for time-consuming manual compression and prolonged observation periods
2Reliability
If bioabsorbable fasteners are used to stop bleeding, then hemostasis can be achieved, but there is risk of complications such as hematoma and pseudoaneurysm formation
Solution Approach 1:
The device uses a suture as an intermediary element that bridges the puncture closure element and the surrounding tissue. This suture mediator distributes forces evenly and reinforces the closure, reducing the risk of complications such as hematoma and pseudoaneurysm formation that can occur with bioabsorbable fasteners alone
Solution Approach 2:
The device combines different materials with complementary properties: a non-bioabsorbable puncture closure element for immediate and durable sealing, and a bioabsorbable suture for temporary support and tissue integration. This composite approach leverages the advantages of both material types while minimizing their individual disadvantages
3Adaptability or versatility
If large introducer sheaths are used for vascular access, then interventional procedures can be performed, but the risk of complications from compression increases
Solution Approach 1:
The device segments the closure function into a dedicated closure element and suture system, allowing effective sealing of large puncture sites created by large introducer sheaths. This segmented approach provides reliable hemostasis for large accesses without the excessive compression risks associated with manual techniques
4Ease of operation
If needles are deployed through the shaft wall, then suturing can be performed, but precise positioning is required to avoid complications
Solution Approach 1:
The device employs dynamic, deployable arms that can be positioned at non-perpendicular angles to the shaft. These arms provide movable needle support structures that accommodate various vessel orientations and depths, achieving precise needle placement without requiring extremely tight manufacturing tolerances on the shaft itself
Data Source
AI summary
A device for suturing an opening in a tissue, having an elongated shaft, at least two arms movable to a deployed positioning which the arms are non-perpendicular to the shaft, the arms having needle receiving portions; and needles advanceable longitudinally along the shaft toward the needle receiving portions, the needles exiting through side walls of the shaft at a location proximal to the arms.