Deflectable Stylet With Bend-Enhancing Region For Catheter Control

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Solution Overview

Problem

Existing cardiac catheters face difficulties in maneuvering their distal parts to awkwardly situated areas of the heart wall, requiring improved flexibility and control for precise tissue contact during procedures.

Innovation Solution

A deflectable stylet with a bend-enhancing region, actuator, control member, and deflection control mechanism, allowing adjustable deflection and torsional stiffness, is integrated into a catheter system. The stylet features an elongate deflectable member with longitudinally spaced slots and a pull wire actuator, enabling variable curvature and positioning within the catheter's lumen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a flexible catheter is used to access awkwardly situated heart wall areas, then the catheter can reach difficult positions, but the catheter lacks sufficient control for precise tissue contact

Engineering Contradiction:
Improveability to reach awkwardly situated areasVSAvoidcontrol for precise tissue contact
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The catheter is divided into multiple sections with different flexibility characteristics. The proximal section has higher flexural rigidity for stable control, while the distal section has lower flexural rigidity for navigation into awkward areas. This segmentation allows each section to perform its specific function optimally.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter incorporates a deflectable stylet with adjustable deflection characteristics. The stylet can be dynamically repositioned within the catheter lumen using a control mechanism, allowing the operator to adjust the catheter's curvature and orientation in real-time to achieve precise tissue contact while maintaining the ability to reach difficult positions.

Inventive Principle:
Principle #15Dynamics

2Measurement precision

If a deflectable stylet with multiple control elements is added to the catheter, then control precision is improved, but device complexity increases

Engineering Contradiction:
Improvepositioning accuracy of distal catheterVSAvoidnumber of control mechanisms
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The deflectable stylet is nested within the catheter lumen, with the stylet's control mechanism integrated into the catheter's existing structure. The stylet's distal end is fastened to the catheter wall, creating a compact nested arrangement that provides enhanced control without significantly increasing overall device complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The deflectable stylet serves multiple functions: it provides structural support to the flexible catheter, enables navigation into awkwardly situated areas, and allows precise positioning through deflection control. This multi-functionality reduces the need for separate control mechanisms that would otherwise be required.

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

3Ease of manufacture

If low-cost materials are used for the deflectable stylet, then manufacturing cost is reduced, but material performance may be compromised

Engineering Contradiction:
Improvemanufacturing costVSAvoidperformance consistency
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent specifies particular parameter ranges for the low-cost materials used in the deflectable stylet, including flexural rigidity (10^-6 to 10^-3 Nm), tensile strength (50-200 MPa), and elongation at break (10-50%). By controlling these parameters, the patent ensures that inexpensive materials meet the necessary performance requirements for reliable catheter operation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The deflectable stylet is constructed from composite materials that combine low-cost components with enhanced mechanical properties. This composite approach allows the use of inexpensive base materials while achieving the required performance characteristics through material composition and structural design.

Inventive Principle:
Principle #40Composite materials

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 stylet enhances the catheter's ability to accurately position the distal part, providing greater flexibility and versatility for accessing hard-to-reach heart areas, while being cost-effective for one-time use due to low-cost materials.

Implementation Method 1

an actuator having a distal end fast with a distal end of the deflectable member, relative displacement between the actuator and the deflectable member causing deflection of the distal part of the deflectable member at the bend-enhancing region

Methodology Applied
Scientific EffectTension: Tension

Implementation Method 2

an elongate deflectable member with a bend-enhancing region defined at a distal part of the deflectable member

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP2002859B1A deflectable stylet
Publication Date: 2019.09.18 CATHRX LTD
  • EP2002859B1 patent drawingFigure 1
  • EP2002859B1 patent drawingFigure 2
  • EP2002859B1 patent drawingFigure 3~4

AI summary

A deflectable stylet 10 for a catheter includes an elongate deflectable member 12 with a bend-enhancing region 20 defined at a distal part of the deflectable member 12. An actuator 16 has a distal end 16. 1 fast with a distal end 12.1 of the deflectable member 12, relative displacement between the actuator 16 and the deflectable member 12 causing deflection of the distal part of the deflectable member 12 at the bend-enhancing region 20. A control member 18 is displaceably arranged relative to the deflectable member 12, the control member 18 interacting with the bend-enhancing region 20 of the deflectable member 12 for controlling the extent of deflection of the distal part of the deflectable member 12.