Biliary Access Endcap Assembly for Secure Medical Device Delivery
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Solution Overview
Problem
Existing medical devices face challenges in efficiently delivering and deploying medical devices, such as expandable stents, through biliary access devices, particularly in navigating complex anatomical structures and ensuring secure and controlled delivery.
Innovation Solution
A biliary access device with a delivery endcap assembly that includes a securement portion, a tapered portion, a rotation hub, and a valve, allowing for the secure attachment of medical devices and enabling their advancement through the device, along with a lumen for accommodating medical devices like expandable stents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a biliary access device is used to deliver medical devices through complex anatomical structures, then the ability to access difficult sites is improved, but the device complexity increases
Solution Approach 1:
The biliary access device is divided into multiple functional segments including a delivery endcap assembly, securement portion, tapered portion, rotation hub, valve, and electrosurgical sheath. Each segment performs a specific function and can be independently manipulated or removed, allowing the device to navigate complex anatomical structures while maintaining manageable complexity through modular design
Solution Approach 2:
The delivery endcap assembly serves multiple functions: it secures the medical device for delivery, provides a pathway through the electrosurgical sheath, and can be removed after delivery. The rotation hub enables both rotation and securement functions. This multi-functionality reduces the need for separate devices, improving adaptability while controlling overall system complexity
2Reliability
If a delivery endcap assembly with securement portion is used to secure medical devices, then the securement reliability is improved, but the device complexity increases
Solution Approach 1:
The securement portion is integrated directly into the delivery endcap assembly, combining the functions of securing the medical device and providing the delivery pathway in a single component. This merging reduces the number of separate parts needed for securement, improving reliability through better integration while minimizing the increase in device complexity
Solution Approach 2:
The medical device is nested within the delivery endcap assembly during the delivery phase. The delivery endcap assembly itself is nested within the electrosurgical sheath. This nested configuration ensures securement through tight integration while maintaining a compact overall structure that doesn't excessively increase device complexity
3Ease of operation
If multiple removable components are used in the biliary access device, then the ease of operation for device delivery is improved, but the device complexity increases
Solution Approach 1:
The delivery endcap assembly is pre-assembled with the securement portion, tapered portion, and rotation hub in their correct configurations before use. The access cannula and stylet are pre-positioned within the electrosurgical sheath. This preliminary preparation simplifies the operator's task during the procedure, improving ease of operation while the modular nature of these pre-assembled components keeps the overall device complexity manageable
Solution Approach 2:
The device incorporates dynamic elements including the rotation hub that can rotate and lock into position, the electrosurgical sheath that can be advanced and retracted, and the delivery endcap assembly that can be secured and removed. These dynamic components allow the device to adapt during the procedure, improving ease of operation through flexible manipulation while the defined mechanical interfaces control the increase in device complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Facilitates the secure and controlled delivery of medical devices, such as expandable stents, through complex anatomical pathways, enhancing the effectiveness and precision of medical procedures.
Implementation Method 1
an electrosurgical sheath that is movable relative to the handle, the electrosurgical sheath including an electrosurgical tip
Data Source
AI summary
A delivery endcap assembly is adapted for use with a biliary access device and is adapted to permit a medical device to be delivered through the biliary access device. The delivery endcap assembly includes a securement portion adapted to be releasably securable to a proximal end of the handle after the one or more removable components have been removed from the handle, a tapered portion extending proximally from the securement portion, a rotation hub adapted to be coupled to the securement portion, a valve adapted to be coupled to the rotation hub and a lumen extending through the delivery endcap assembly, wherein the lumen extending through the delivery endcap assembly is adapted to permit a medical device within an introducer sheath to be advanced through the biliary access device.