Barbed Suture Implant for Incidental Durotomy Closure
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Solution Overview
Problem
Incidental durotomy during spinal surgeries, where a tear in the dura mater occurs, poses challenges in timely and effective closure, leading to complications like CSF leaks, prolonged surgery, and increased costs due to the complexity of suturing and potential need for reoperation.
Innovation Solution
A barbed suture-based implant system with two discs, where one disc is statically coupled to the suture and the other is moveably coupled, allowing for rapid deployment and sealing of tissue openings, including durotomies, using a delivery device to extend and retract the discs for secure closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If primary closure with suture is used to close incidental durotomy, then the dura can be closed, but the repair procedure becomes lengthy and complicated
Solution Approach 1:
The patent extracts the complex suturing process and replaces it with a simplified implant system consisting of a closure device and sealant that can be quickly deployed without traditional needle passage through the dura, thereby reducing repair time while maintaining closure efficacy
Solution Approach 2:
The patent introduces a sealant as an intermediary substance between the dural edges to achieve closure without direct suturing. The sealant fills and seals the dural defect, providing a alternative mechanism for closure that avoids the time-consuming suturing process
2Reliability
If primary closure with suture is used to close incidental durotomy, then the tear can be closed, but the procedure becomes complicated requiring careful avoidance of spinal cord injury
Solution Approach 1:
The patent removes the needle and suture thread from the closure process, replacing them with a deployable closure device that mechanically approximates dural edges without penetrating the spinal cord, thereby reducing procedure complexity while maintaining closure efficacy
Solution Approach 2:
The patent employs a disposable single-use implant system that is pre-packaged and deployed in one action, eliminating the need for complex suturing techniques and reducing the skill barrier and procedural complexity associated with traditional suture-based closure
3Adaptability or versatility
If secondary closure with patch and sealant is used when primary closure is not feasible, then closure can be attempted, but it is only attempted with hopes that the dural patch and sealant will be sufficient
Solution Approach 1:
The patent merges the primary closure function (dural edge approximation) and secondary closure function (sealing) into a single integrated implant system where the closure device and sealant work together as a unified mechanism, providing both adaptability to inaccessible locations and reliable closure efficacy
Data Source
AI summary
The disclosure provides an example implant, surgical systems, and methods for closing a tissue opening. The implant includes a barbed suture having a first end and a second end. A first disc statically coupled to the first end of the barbed suture at a center of the first disc. And a second disc having a through-hole arranged in a center of the second disc, where the second disc is moveably coupled to the barbed suture via the through-hole.