Steerable Sheath Handle with Threaded Slider Position Indicator

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Solution Overview

Problem

Existing steerable sheaths lack a clear indication of the amount and direction of deflection of the distal tip, relying on fluoroscopy which increases radiation exposure and complicates procedures like transseptal crossing.

Innovation Solution

A steerable sheath with a handle that includes a rotatable knob, a slider with raised and inverted threads, and a position ring with bevel gears connected to a position indicator, providing a visual cue of the deflectable distal tip's curve direction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopy is used to indicate distal tip position, then the user can see the sheath position, but radiation exposure to user and patient increases

Engineering Contradiction:

Improvedistal tip position indicationVSAvoidradiation exposure

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent creates a visual copy of the distal tip position and orientation on the handle through the position indicator mechanism. The position indicator displays the curve direction and degree of the distal tip without requiring fluoroscopy, thus eliminating radiation exposure while maintaining position awareness capability.

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The patent introduces an intermediary mechanical linkage system (slider, threads, bevel gears, position ring) that translates the distal tip's physical position and orientation into a visual indication on the handle. This intermediary mechanism allows the user to perceive distal tip status without direct radiation exposure.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If multiple steerable sheaths are used simultaneously, then more procedures can be performed, but the sheaths cannot be distinguished based on their curve positions

Engineering Contradiction:

Improvenumber of proceduresVSAvoidcurve position distinction

Core Design Contradiction:

ProductivityVSLoss of information

Solution Approach 1:

The patent employs color-coded position indicators on the handle to distinguish multiple sheaths by their curve positions. Different colors or color variations indicate different curve directions or degrees, allowing operators to quickly identify and differentiate between multiple sheaths during complex procedures.

Inventive Principle:

Principle #32Color changes

3Duration of action of moving object

If more than one rotation of the knob is required to fully deflect the sheath, then the deflection range is increased, but it is difficult to correlate the amount of knob rotation with the amount of distal portion sheath deflection

Engineering Contradiction:

Improvedeflection rangeVSAvoidcorrelation between knob rotation and deflection amount

Core Design Contradiction:

Duration of action of moving objectVSLoss of information

Solution Approach 1:

The patent implements a feedback mechanism where the position indicator continuously displays the current deflection state of the distal tip in relation to knob rotation. This visual feedback allows the operator to directly correlate the amount of knob rotation with the resulting sheath deflection, improving control precision without limiting the deflection range.

Inventive Principle:

Principle #23Feedback

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 solution allows for precise control and visualization of the steerable sheath's deflection, reducing radiation exposure and improving the accuracy of procedures by providing a clear indication of the distal tip's position and direction.

Implementation Method 1

the position ring and the position indicator each having one or more bevel gears connecting the position ring to the position indicator

Methodology Applied

Scientific EffectGear mechanism: Gear

Implementation Method 2

a slider running through a portion of the handle having a raised thread and an inverted thread, a first direction of the raised thread being inverse to a second direction of the inverted thread

Methodology Applied

Scientific EffectScrew mechanism: Screw

Data Source

PatentUS20250127564A1Deflectable sheath with indicator

Publication Date: 2025.04.24 BOSTON SCI MEDICAL DEVICE LTD

AI summary

A steerable sheath is disclosed. The steerable sheath includes an elongate member, the elongate member having a proximal portion and a distal portion terminating in a deflectable distal tip. The steerable sheath further includes a handle having a handle proximal portion and a handle distal portion that is connected to the proximal portion of the elongate member. The handle of the steerable sheath includes a knob positioned at the distal portion of the handle; a slider running through a portion of the handle having a raised thread and an inverted thread; and a position ring located proximate a position indicator, wherein rotation of the knob acts upon the raised thread to cause a linear movement of the slider which acts upon the inverted thread to cause a rotational movement of the position ring.