Introducer Sheath Bypass Flap for Continuous Blood Perfusion

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Solution Overview

Problem

Existing introducer sheaths disrupt blood flow for extended periods, increasing the risk of critical limb ischemia when medical devices are left in place for prolonged durations.

Innovation Solution

Incorporation of a fluid bypass mechanism in the introducer sheath, such as a movable flap or door, that can be actuated to allow blood flow through the sheath while maintaining hemostasis, using a pull wire or shape memory materials to control the flap's position.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a sheath is inserted into a blood vessel to deliver medical devices, then the medical device can be introduced and removed easily, but blood flow is disrupted and ischemia risk increases

Engineering Contradiction:

Improvemedical device introduction and removalVSAvoidblood flow disruption and ischemia

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The sheath wall is segmented by forming a flap that can be independently actuated to create a bypass opening, allowing blood to flow around the sheath while maintaining the sheath's structural integrity and sealing function

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A pull wire is introduced as an intermediary element to transmit actuation force from the proximal end of the sheath to the flap mechanism at the distal end, enabling remote control of the bypass opening without direct manipulation at the insertion site

Inventive Principle:

Principle #24Intermediary (Mediator)

2Duration of action of stationary object

If the sheath remains in place for extended periods to facilitate medical device use, then continuous access is maintained, but blood flow disruption persists and patient comfort decreases

Engineering Contradiction:

Improvesheath retention timeVSAvoidprolonged blood flow disruption

Core Design Contradiction:

Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The sheath transitions from a static, fully occlusive structure to a dynamic system with a controllable bypass opening, allowing blood flow to be restored while the sheath remains in place for extended periods

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The bypass mechanism enables continuous blood flow through the flap opening while the sheath maintains its position and function for prolonged durations, eliminating the need for frequent removal and reinsertion

Inventive Principle:

Principle #20Continuity of useful action

3Object-affected harmful factors

If a fluid bypass mechanism is added to the sheath, then blood flow disruption is minimized, but device complexity increases

Engineering Contradiction:

Improveblood flow disruptionVSAvoidsheath structure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The bypass flap is constructed from flexible materials that allow it to be integrated into the sheath wall while maintaining the sheath's overall flexibility and ease of insertion, avoiding rigid complex mechanisms

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The bypass function is extracted as a separate, independently actuated flap mechanism rather than being integrated into the main sheath body, allowing simplified control through the pull wire system

Inventive Principle:

Principle #2Taking out (Extraction)

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

Minimizes blood flow disruption by enabling continuous blood perfusion around the sheath, reducing the risk of ischemia and enhancing patient comfort during prolonged medical device procedures.

Implementation Method 1

a pull wire coupled to the fluid bypass mechanism... actuation of the actuation mechanism may be configured to move the fluid bypass mechanism between a generally closed configuration and an open configuration

Methodology Applied

Scientific EffectMechanical force transmission: Mechanical Force

Implementation Method 2

the biasing mechanism may comprise a shape memory material

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 3

the movable flap may be configured to be deflected radially inwards... configured to selectively fluidly couple the lumen of the elongate shaft with an exterior thereof

Methodology Applied

Scientific EffectFluid flow through opening:

Data Source

PatentUS20250319284A1Introducer sheath with blood bypass mechanism

Publication Date: 2025.10.16 BOSTON SCIENTIFIC SCIMED INC

AI summary

A hub and sheath assembly configured to selectively fluidly couple a lumen of the sheath with an exterior thereof. The hub and sheath assembly may comprise a valve hub including a lumen extending therethrough. An elongate shaft may extend from a proximal end region to a distal end region and include a lumen extending therebetween. The elongate shaft may be coupled to the valve hub. A fluid bypass mechanism may extend through a sidewall of the elongate shaft. The fluid bypass mechanism may be configured to selectively fluidly couple the lumen of the elongate shaft with an exterior thereof.