Bi-directional Stent Delivery via Shuttle Sheath Coupling

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Solution Overview

Problem

Current stent delivery systems face challenges in precise deployment, particularly for self-expanding stents, which can 'jump' away from the delivery catheter during deployment, and lack bi-directional deployment capabilities, limiting accurate placement in complex anatomical regions like the venous system, where exact positioning is critical for successful clinical outcomes.

Innovation Solution

A bi-directional stent delivery system featuring an inner and outer elongate shaft with a middle shaft and a shuttle sheath, allowing for both distal and proximal stent expansion directions, enabling precise control and deployment in various anatomical orientations, including the venous system, through a distal or proximal release mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a conventional stent delivery system with single-direction release is used, then the deployment process is simple, but the placement precision in complex anatomical regions is insufficient

Engineering Contradiction:
Improvestent placement precisionVSAvoiddelivery system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The delivery system employs dynamic coupling mechanisms that allow the shuttle sheath to be selectively coupled to either the inner shaft or outer shaft during deployment. This dynamic reconfiguration enables the system to adapt between different deployment directions (proximal or distal release) based on anatomical requirements, thereby improving placement precision without requiring multiple fixed systems

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The delivery system integrates both proximal and distal release capabilities into a single unified device through the shuttle sheath mechanism. The same delivery system can be used for different anatomical configurations by simply changing the coupling state, eliminating the need for separate delivery systems for different deployment directions and reducing overall device complexity

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

2Manufacturing precision

If self-expanding stents are deployed with conventional delivery systems, then the deployment process is straightforward, but the stents may jump away from the delivery catheter causing inaccurate placement

Engineering Contradiction:
Improvestent placement precisionVSAvoiddeployment control
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The shuttle sheath acts as an intermediary component between the stent and the delivery shafts. It provides a controlled interface that maintains stent positioning during deployment while allowing precise release when needed. The coupling mechanisms (proximal and distal) serve as intermediaries to control the shuttle sheath's movement, enabling accurate stent placement without the stent jumping away

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system performs preliminary coupling of the shuttle sheath to the appropriate shaft (inner or outer) based on the desired deployment direction before actual stent release. This preliminary configuration ensures that the stent remains securely positioned until the exact moment of deployment, preventing premature jumping while maintaining ease of operation

Inventive Principle:
Principle #10Preliminary action

3Productivity

If multiple stents are deployed with conventional single-direction systems, then each stent requires a separate delivery system, but this increases procedural complexity and time

Engineering Contradiction:
Improveprocedural efficiencyVSAvoidnumber of delivery systems
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The delivery system is designed with universal coupling mechanisms that allow the same device to deploy multiple stents in different directions. By selectively coupling the shuttle sheath to either the inner or outer shaft, the system can handle various stent deployment scenarios (proximal or distal release) with a single device, improving procedural efficiency without increasing the number of delivery systems needed

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

Solution Approach 2:

The delivery system is segmented into distinct functional components (inner shaft, outer shaft, shuttle sheath, coupling mechanisms) that can be independently controlled. This segmentation allows flexible configuration for deploying multiple stents with different release directions, enabling complex multi-stent procedures to be performed with one delivery system rather than requiring multiple separate systems

Inventive Principle:
Principle #1Segmentation

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

The system ensures accurate and controlled deployment of stents in complex anatomical regions, reducing the risk of understenting, overstenting, or inaccurate placement, and allows for flexible deployment strategies to accommodate different anatomical features and access sites, enhancing clinical outcomes.

Implementation Method 1

Self-expanding stents are made from a material that is resiliently biased to return to a pre-set shape. These materials may include superelastic and shape memory materials that can expand to an implanted configuration upon delivery or through a change in temperature.

Methodology Applied
Scientific EffectElastic recovery: Elasticity

Implementation Method 2

Self-expanding stents are made from a material that is resiliently biased to return to a pre-set shape. These materials may include superelastic and shape memory materials that can expand to an implanted configuration upon delivery or through a change in temperature.

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentEP2579822B8Bi-directional stent delivery system
Publication Date: 2019.09.04 BOSTON SCIENTIFIC SCIMED INC

AI summary

A bi-directional stent delivery system includes an inner elongate shaft, a radially expandable prosthesis disposed over the inner elongate shaft, an outer elongate shaft, and a shuttle sheath disposed over the radially expandable prosthesis. The distal portion of the inner shaft is releasably coupled to the distal portion of the shuttle sheath, and the distal portion of the outer shaft is releasably coupled the proximal portion of the shuttle sheath. Distal advancement of the inner shaft advances the shuttle sheath distally when the outer shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a proximal end to a distal end. Proximal retraction of the outer shaft retracts the shuttle sheath proximally when the inner shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a distal end to a proximal end thereof.