Stent Delivery System with Deployable Sealing Membrane

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Solution Overview

Problem

Standard endoscopic retrograde cholangiopancreatography (ERCP) procedures are limited in accessing bile ducts when obstructions are large or difficult to pass, and may cause pancreatitis due to repeated prodding of the major duodenal papilla, necessitating an alternative antegrade approach like the 'Rendezvous' procedure, which is time-consuming and prone to guide wire placement issues.

Innovation Solution

A stent delivery system with a deployable member that deploys from the stent body to cover the access hole after withdrawal, preventing bile leakage into surrounding tissue, and includes various designs such as flaps, accordion tubes, and self-sealing membranes to ensure effective sealing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If standard retrograde ERCP approach is used, then biliary obstruction can be treated, but the procedure causes pancreatitis due to repeated prodding of the major duodenal papilla

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidpancreatitis risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent inverts the traditional retrograde approach by using an antegrade approach through EUS-guided access. Instead of advancing the guide wire and stent from the duodenum upward through the papilla, the system accesses the bile duct from the liver side and deploys the stent downward, eliminating the need to repeatedly probe the papilla and reducing pancreatitis risk

Inventive Principle:
Principle #13The other way round (Inversion)

2Reliability

If antegrade Rendezvous procedure is used, then biliary access is achieved, but the procedure is time consuming and requires complex scope exchange

Engineering Contradiction:
Improvebiliary access successVSAvoidprocedural time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent performs preliminary actions by pre-positioning the access needle and guide wire through EUS guidance before stent deployment. The delivery system is pre-loaded with the stent and positioned ready for deployment, eliminating the need for complex scope exchanges and multiple procedural steps required in traditional Rendezvous procedures

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent combines the EUS access needle, guide wire, and stent delivery system into an integrated system. The needle serves dual purposes for both access and as a delivery mechanism, merging multiple functions into a single unified approach that reduces procedural complexity and time

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If access hole is left open after stent deployment, then stent delivery is simple, but bile leaks into surrounding tissue causing complications

Engineering Contradiction:
Improvestent delivery simplicityVSAvoidbile leakage
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The patent employs a flexible membrane seal that conforms to the access tract and seals around the delivery system. This thin film barrier prevents bile leakage while allowing the delivery system to pass through, maintaining ease of operation while eliminating the harmful effect of bile leakage into surrounding tissues

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentUS11207172B2Stent designs to cover catheter access site
Publication Date: 2021.12.28 COVIDIEN LP
  • US11207172B2 patent drawing
  • US11207172B2 patent drawing
  • US11207172B2 patent drawing

AI summary

Methods, apparatuses and systems are described for delivering a stent through an access hole of a body lumen and covering up the access hole after deploying the stent, Stents are described that include a stent body defining a body lumen contact surface area and a deployable member configured to deploy from the stent body and increase the body lumen contact surface area of the stent. Deployable members that hinge, unroll, extend, expand, and coaxially translate with respect to the stent body are described. A system for delivering a stent into a body lumen are described that may include a coverage member configured to at least partially cover the hole in the wall of the stent upon withdrawing a tubular member through the hole in the wall of the stent. Coverage members may include a self-sealing membrane, a flap valve, or a hinged valve.