Biopsy Cap Internal Seal With Helical Flaps for Passive Leakage Control
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Solution Overview
Problem
Existing endoscope assemblies, biopsy caps, and seals face challenges in providing effective sealable access to the working channel, leading to leakage of bodily fluids and air, and require active clinician intervention for sealing.
Innovation Solution
A seal design for endoscopes featuring a main body with circumferentially and angularly offset projections or helical flaps that spiral inward, forming a monolithic structure to create a passive seal, allowing medical devices to pass through while preventing fluid leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing seals are used, then medical devices can pass through the working channel, but fluid leakage occurs and active clinician intervention is required for sealing
Solution Approach 1:
The seal member is designed to automatically seal the working channel when a medical device is inserted. The projections on the seal member engage with the device and passively prevent fluid leakage without requiring any active sealing action from the clinician. The system serves itself by using the presence of the medical device to trigger the sealing mechanism.
Solution Approach 2:
The seal member features a dynamic structure with projections that can flex and adapt to the medical device inserted through the working channel. The projections are positioned to engage with the device and create a seal that adjusts to the device's presence, transforming the static seal into a dynamic response system.
2Reliability
If a passive seal mechanism is implemented, then fluid leakage is prevented, but the complexity of the seal structure increases
Solution Approach 1:
The seal member is segmented into multiple projections arranged in circumferentially and angularly offset layers. Each projection acts as an independent sealing element that can engage with the medical device. This segmentation allows the complex sealing function to be achieved through multiple simple, identical components rather than a single complex structure.
Solution Approach 2:
The projections are arranged in a spiral configuration around the central lumen, creating a curved, three-dimensional sealing surface. This spiral arrangement of projections provides effective sealing in multiple directions and planes, using curvature to enhance the passive sealing capability without requiring additional complex mechanisms.
3Extent of automation
If multiple projections in offset layers are used, then passive sealing is achieved, but manufacturing complexity increases
Solution Approach 1:
The seal member integrates multiple functional features into a single molded component. The projections, circumferential wall, and central lumen are all formed in one injection molding process rather than being assembled from separate parts. This merging of features into a monolithic structure simplifies manufacturing despite the complex geometry of the spiral projections.
Solution Approach 2:
The molding process parameters are optimized to accommodate the spiral projection geometry. By adjusting the molding parameters such as injection pressure, temperature, and cycle time, the complex multi-layered projection structure can be manufactured efficiently in a single shot, transforming a potentially complex assembly into a straightforward molding operation.
Data Source
AI summary
Biopsy caps and seals, and methods for making and using the same may be provided in conjunction with an endoscope assembly. A seal may include a main body including a circumferential outer wall surrounding a central lumen. The seal may include at least one support wall extending radially from the outer wall towards a center of the lumen, and at least one helical flap extending from the support wall helically downward along an inner surface of the outer wall, where the at least one helical flap defines an opening at the center of the lumen. The seal may alternatively include a plurality of projections extending radially inward from the outer wall towards a center of the lumen, where the plurality of projections are arranged in a series of circumferentially and angularly offset layers.