Tissue Anchor Deployment via Needle Lumen and Suture Lock
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Solution Overview
Problem
Existing medical devices face challenges in efficiently deploying multiple tissue anchors due to premature deployment of proximally arranged anchors during the deployment of distally arranged anchors, and the complexity of manually tying sutures, especially in endoscopic or laparoscopic procedures.
Innovation Solution
A medical device with a needle lumen that slidably receives tissue anchors, an over-the-needle suture lock with a plug and retaining sleeve for securing sutures, and a resorbable spacer member to maintain anchor positioning, allowing for sequential deployment and secure suture fixation without the need for frequent reloading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If multiple tissue anchors are deployed sequentially using a single needle, then the number of needle reloads is reduced, but the risk of premature deployment of proximally arranged anchors increases
Solution Approach 1:
Multiple tissue anchors are nested within the single needle lumen in a serial arrangement, with each anchor contained within the needle until its designated deployment moment. This nesting allows multiple anchors to be transported and positioned without premature deployment, resolving the contradiction between deploying multiple anchors efficiently and maintaining control over their sequential deployment.
Solution Approach 2:
The tissue anchors are pre-loaded and pre-positioned within the needle lumen before the procedure begins. This preliminary action allows the operator to prepare multiple anchors in advance, enabling efficient sequential deployment without repeated needle reloads while maintaining precise control over when each anchor is deployed.
2Manufacturing precision
If tissue anchors are held in place during reloading, then deployment accuracy is maintained, but device positioning stability becomes difficult to maintain
Solution Approach 1:
The device is segmented into distinct functional components: the needle for anchor delivery, the suture lock mechanism for securing anchors, and the introduction catheter for navigation. This segmentation allows each component to perform its specific function independently, maintaining device stability during anchor reloading while enabling precise anchor deployment when needed.
3Manufacturing precision
If manual suture tying is performed to close perforations, then closure precision can be achieved, but procedural time and complexity increase significantly
Solution Approach 1:
The suture lock mechanism is designed to automatically secure the suture and maintain tension without requiring manual tying by the operator. The anchor's own suture feeds through the lock mechanism, which self-secures upon deployment, eliminating the time-consuming manual suture tying step while maintaining precise perforation closure.
Solution Approach 2:
The complex manual suture tying operation is replaced by a simplified mechanical suture lock mechanism. This mechanism uses the anchor's own suture and a locking structure to achieve secure closure, substituting the skill-intensive manual tying process with a more efficient mechanical system that reduces procedural time and complexity.
Data Source
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AI summary
Medical devices, systems and related methods for delivering a plurality of tissue anchors. The medical devices generally comprise a needle and an over-the-needle suture lock, employed via inner and outer sheaths. The medical systems include a plurality of tissue anchors and at least one biodegradable or resorbable spacer member positioned between adjacent tissue anchors in conjunction with the medical devices.