Asynchronous Needle Capture for Suture Delivery
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Solution Overview
Problem
Existing methods for closing vascular punctures require significant manual effort and can be uncomfortable for patients, with risks of unintended occlusion and thrombosis, and existing suture delivery devices require high actuation force to deploy needles accurately.
Innovation Solution
A suture delivery device with an elongated deployment shaft, needle deployment assembly, stabilizer, catcher tube, and sheath that allows asynchronous engagement of needles, reducing the actuation force required to deploy and capture multiple needles by engaging subsets of needles at different times.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If multiple needles are captured simultaneously by the suture delivering device, then accurate positioning and robust suture location are achieved, but high actuation force is required
Solution Approach 1:
The needle capture process is segmented into multiple phases using a multi-component catcher assembly. The catcher assembly includes a catcher tube with first catching elements and a catcher disk with second catching elements, allowing needles to be captured in sequential groups rather than simultaneously. This segmentation reduces the actuation force required at any given moment while maintaining accurate needle positioning through controlled engagement at different stages of the retraction process.
Solution Approach 2:
The catcher assembly is designed with dynamic engagement characteristics where different components engage needles at different times during the needle retraction process. The first catching elements engage needles at an initial position, and the second catching elements engage needles at a subsequent position as the needle deployment assembly retracts further. This dynamic, staged engagement reduces peak actuation force while ensuring accurate needle capture and positioning.
2Reliability
If manual compression is used to achieve hemostasis, then clot formation is allowed, but significant time is required and patient discomfort increases
Solution Approach 1:
The patent replaces the manual compression mechanical system with an automated suture delivery system. The device uses a needle deployment assembly that can be actuated to deliver sutures through the vessel wall, creating secure closure much faster than manual compression. This mechanical substitution eliminates the need for prolonged manual compression while achieving reliable hemostasis through precise suture placement.
3Adaptability or versatility
If suture delivery device is introduced through the same opening, then minimal invasiveness is maintained, but accurate needle positioning relative to vessel wall is challenging
Solution Approach 1:
The needle deployment assembly is nested within the deployment shaft, which is introduced through the same vascular opening as the access device. The catcher tube and catching elements are nested within the deployment shaft, allowing the entire assembly to be delivered through a single puncture site. This nested configuration maintains minimal invasiveness while enabling accurate needle positioning through controlled deployment and capture mechanisms that ensure proper orientation relative to the vessel wall.
Data Source
AI summary
An elongated deployment shaft carrying a needle deployment assembly with needles carrying sutures and a stabilizer. A catcher tube over the shaft having a catcher assembly at a distal end may retain a portion of the needles when passed through the tissue into engagement with catcher assembly. The catcher and needle deployment assemblies are configured to asynchronously engage the plurality of needles when moved distally beyond the catcher assembly. A sheath over the catcher tube may sandwich the tissue against the stabilizer when expanded. A first actuator may move catcher tube distally to decrease distance between proximal and distal ends of the stabilizer expand it and may move the sheath distally to sandwich the tissue. A second actuator may deflect the needles outward to move proximally through the tissue and engage the catcher and return a portion of each not retained by the catcher to a distal position.