EUS-Guided Access Sheath for Controlled Duct Puncture and Dilation
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Solution Overview
Problem
Existing endoscopic procedures for draining fluid-filled ducts, such as the bile or pancreatic ducts, are inefficient and lack effective methods for accessing and dilating obstructed ducts to facilitate drainage, particularly in cases of blockages due to cancer, gallstones, or scarring.
Innovation Solution
An endoscopic ultrasound (EUS) guided drainage system comprising a sharp for puncturing the duct, an access sheath for insertion, and a dilating sheath for dilation, equipped with a handle assembly for control and electrosurgical capabilities, allowing precise access and dilation under ultrasound guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sharp needle is used to puncture the duct, then puncture effectiveness is improved, but safety and control during insertion deteriorate
Solution Approach 1:
The sharp needle is nested within the access sheath, which itself is nested within the dilating sheath. This nested configuration allows the sharp needle to be safely contained during insertion and only exposed when needed for puncture, resolving the contradiction between puncture effectiveness and control/safety during insertion.
Solution Approach 2:
The access sheath is pre-positioned within the dilating sheath before the procedure begins. This preliminary arrangement allows the operator to first establish safe access through the dilating sheath, then introduce the sharp needle only when ready to puncture, improving both safety during insertion and puncture effectiveness.
2Adaptability or versatility
If multiple separate devices are used for puncture and dilation, then functional versatility is improved, but device complexity and procedural efficiency deteriorate
Solution Approach 1:
The patent combines the puncture function (sharp needle) and dilation function (dilating sheath) into a single integrated system where both components are nested within each other. This merging allows both functions to be performed using one device assembly, improving procedural efficiency while maintaining functional versatility.
Solution Approach 2:
The access sheath serves multiple functions: it protects the sharp needle during insertion, provides a pathway for the needle, and remains in place to guide subsequent dilation. This multi-functionality reduces the need for separate devices while maintaining versatility.
3Strength
If a rigid structure is used for the access sheath, then structural strength is improved, but flexibility and maneuverability deteriorate
Solution Approach 1:
The access sheath is designed with flexible materials and structures that allow it to bend and conform to anatomical structures during insertion, while maintaining sufficient strength to protect the sharp needle and support the dilation function. This flexibility improves maneuverability without sacrificing essential structural strength.
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
Enables efficient and controlled drainage of fluid-filled ducts by ensuring accurate puncture and dilation, reducing procedural complexity and enhancing the visibility and maneuverability of the system for effective duct access and treatment.
Implementation Method 1
a flexible tip coupled to the distal end of the elongated tube, the flexible tip biased to a curved configuration
Implementation Method 2
equipped with a handle assembly for control and electrosurgical capabilities
Data Source
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AI summary
The present invention discloses a system for endoscopic ultrasound guided drainage, comprising: an access sheath including an elongated tube extending longitudinally from a proximal end to a distal end and including an access lumen extending therethrough from the proximal end to the distal end, the distal end of the access sheath forming a flexible tip biased toward a curved configuration; a sharp slidably received within the access lumen, the sharp extending longitudinally from a proximal end to distal end and including a fluid channel extending therethrough to at least one opening in a distal end of the sharp, the sharp being configured so that, when the sharp is received within the distal end of the access sheath, the flexible tip of the access sheath is straightened; and a dilating sheath extending longitudinally from a proximal end to a distal end and including a dilating lumen extending therethrough, the dilating lumen sized and shaped to slidably receive the access sheath.