Delivery Endcap Assembly for Precise Biliary Stent Placement

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Solution Overview

Problem

Existing medical devices face challenges in efficiently accessing and delivering medical devices, such as expandable stents, to biliary and pancreatic ducts, particularly due to limitations in design and functionality for precise placement and deployment.

Innovation Solution

A biliary access device with a handle, electrosurgical sheath, and a delivery endcap assembly that allows for the removable components like a sharp stylet and access cannula, enabling precise puncture, guidewire placement, and deployment of medical devices like expandable stents through a combination of mechanical and electrosurgical mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a biliary access device is used to deliver medical devices to biliary and pancreatic ducts, then precise placement and deployment is improved, but device complexity increases due to multiple removable components and assembly requirements

Engineering Contradiction:
Improveplacement precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The biliary access device is divided into multiple separable components including a handle, electrosurgical sheath, access cannula, sharp stylet, and interchangeable endcap assemblies. This segmentation allows each component to be optimized for specific functions while enabling modular assembly and disassembly, resolving the contradiction between placement precision and device complexity by allowing the operator to assemble only the necessary components for each procedure step

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates universal features such as a standardized handle that can accept different endcap assemblies (access endcap and delivery endcap), and an electrosurgical sheath that can accommodate various medical devices for delivery. This multi-functionality allows a single base device to perform multiple procedures, improving placement precision across different applications while managing complexity through standardized interfaces

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Ease of operation

If removable components like sharp stylet and access cannula are used, then ease of operation is improved for guidewire placement, but device complexity increases due to component removal and replacement steps

Engineering Contradiction:
Improveease of operationVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The sharp stylet and access cannula are pre-assembled with the appropriate endcap assembly before the procedure. The stylet is inserted through the cannula, and the cannula is secured to the handle, creating a ready-to-use configuration that simplifies the operator's task during the procedure while consolidating the complexity into the preliminary assembly phase

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sharp stylet and access cannula are designed as removable components that can be extracted from the device after serving their purpose. The stylet is removed after puncture, and the access cannula is removed after guidewire placement, allowing the base device to be reused for delivery functions without the access components, thus managing complexity through selective component removal

Inventive Principle:
Principle #2Taking out (Extraction)

3Adaptability or versatility

If a delivery endcap assembly is added to the handle, then adaptability is improved for medical device delivery, but device complexity increases due to assembly and configuration steps

Engineering Contradiction:
ImproveadaptabilityVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The handle is designed with a universal interface that can accommodate both access endcap assemblies and delivery endcap assemblies. This allows the same handle to be used for both access procedures (puncture and guidewire placement) and delivery procedures (stent and other device deployment), improving adaptability while managing complexity through standardized mounting mechanisms

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The endcap assemblies are designed to be dynamically interchangeable on the handle during the procedure. The operator can remove the access endcap and replace it with a delivery endcap as the procedure progresses, allowing the device configuration to adapt to different procedural phases without requiring multiple complete devices, thus improving versatility while controlling complexity

Inventive Principle:
Principle #15Dynamics

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 precise access and delivery of medical devices to biliary and pancreatic ducts, enhancing the ability to place and deploy stents accurately, thereby improving treatment efficacy.

Implementation Method 1

an electrosurgical sheath that is movable relative to the handle, the electrosurgical sheath including an electrosurgical tip

Methodology Applied
Scientific EffectElectrosurgical effect: Joule Heating

Data Source

PatentUS20250325301A1Device delivery via biliary access device
Publication Date: 2025.10.23 BOSTON SCIENTIFIC SCIMED INC
  • US20250325301A1 patent drawing
  • US20250325301A1 patent drawing
  • US20250325301A1 patent drawing

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.