Interdigitating Dural Clip Closure for CSF Leak Prevention
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Solution Overview
Problem
Dural openings during surgical procedures can lead to cerebrospinal fluid leakage, causing health complications such as headache and meningitis, and existing methods often involve piercing or perforating the dural tissue, leading to inflammation and scarring.
Innovation Solution
The development of devices like forceps, nerve hooks, and clips with polymer tips and retractable tips for dural closure, which facilitate grasping and retaining tissue without piercing, along with clip delivery systems and kits for sealing dural openings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing methods are used to close dural openings, then the dural tissue can be secured, but the tissue is pierced or perforated causing inflammation and scarring
Solution Approach 1:
A polymer tip acts as an intermediary between the forceps blades and the dural tissue. The polymer tip grasps the tissue without the metal blades piercing it, eliminating direct mechanical trauma while maintaining secure tissue holding for closure procedures
Solution Approach 2:
The forceps with polymer tips are designed as disposable single-use instruments. This eliminates the risk of cross-contamination and ensures each instrument is sterile and pristine for its intended use, while the polymer tip is replaced with each new instrument rather than reused and re sterilized
2Object-affected harmful factors
If forceps with polymer tips are used, then tissue grasping is improved without piercing, but the device complexity increases
Solution Approach 1:
A flexible polymer tip is attached to the rigid forceps blades. The polymer tip conforms to the tissue surface and provides gentle grasping pressure distribution, preventing penetration while maintaining adequate holding force for dural closure maneuvers
3Reliability
If clips with multiple digits are used for dural closure, then the sealing effectiveness is improved, but the device complexity increases
Solution Approach 1:
The clip is segmented into multiple digits (typically three) that can independently engage with the dural tissue. This segmentation allows the digits to conform to the tissue surface and provide distributed compression, creating an effective seal while maintaining a relatively simple overall clip structure
Solution Approach 2:
The clip combines rigid structural elements for mechanical strength with softer contact surfaces that conform to tissue. This composite approach provides both the structural integrity needed for closure and the tissue-friendly characteristics for effective sealing without excessive complexity
Data Source
AI summary
A clip for dural closure can include a base, a first leg extending distally from the base and including a first tip, the first tip including a first plurality of digits, and a second leg extending distally from the base and including a second tip, the second tip including a second plurality of digits. The clip can include a sealant positioned on an underside of the base and configured to provide a fluid seal along at least a portion of a dural opening. The clip is transformable between an open configuration and a closed configuration, wherein the first plurality of digits of the first tip of the first leg are configured to interdigitate with the second plurality of digits of the second tip of the second leg in the closed configuration.