Catheter Strain Relief and Flexible Stylet Tip Design

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Solution Overview

Problem

Catheters used in medical procedures often experience kinking and pinching due to angular constraints, leading to reduced fluid flow and potential tissue irritation, and stiff stylets can cause damage to medical devices or patients.

Innovation Solution

The development of a fluid delivery system with a strain relief member that increases the stiffness of the catheter to prevent kinking and a stylet with a flexible tip to reduce damage, featuring a strain relief component that maintains a bend radius above a critical radius and a stylet with a compliant tip to prevent injury.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a strain relief component is added to eliminate catheter pinching or kinking, then catheter reliability is improved, but device complexity increases

Engineering Contradiction:
Improvecatheter reliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter is divided into distinct segments with different stiffness characteristics. A flexible tip portion is separated from the main catheter body, allowing the tip to bend and conform to anatomical structures while the main body maintains structural integrity and resists kinking. This segmentation resolves the contradiction by providing both flexibility where needed and rigidity where required, improving reliability without adding complex external components.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the catheter are given different mechanical properties. The tip region is made highly flexible to prevent tissue damage and allow navigation, while the proximal portion maintains higher stiffness to prevent kinking and maintain fluid flow. This local differentiation of material properties addresses the contradiction by optimizing each region's characteristics for its specific function.

Inventive Principle:
Principle #3Local quality

2Ease of operation

If a stiff stylet is used to push the catheter into position, then ease of operation is improved, but object-affected harmful factors increase

Engineering Contradiction:
Improveease of operationVSAvoidtissue damage risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The stylet is designed with a flexible tip portion that differs from the rigid shaft. The flexible tip reduces the risk of tissue damage and device injury during insertion, while the rigid shaft maintains sufficient pushing capability to advance the catheter into position. This local differentiation resolves the contradiction between ease of operation and safety.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The flexible tip on the stylet acts as a cushioning element before contact with delicate tissues or devices. This pre-engineered flexibility protects against inadvertent damage during the insertion process, allowing the operator to maintain pushing force without risking tissue injury or device damage.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Manufacturing precision

If the catheter is constrained to enter the device at a fixed angle, then manufacturing precision is improved, but object-generated harmful factors increase

Engineering Contradiction:
Improveentry angle precisionVSAvoidkinking and pinching
Core Design Contradiction:
Manufacturing precisionVSObject-generated harmful factors

Solution Approach 1:

The catheter entry region is segmented into a fixed-angle interface portion and a flexible transition portion. The fixed-angle portion ensures precise alignment with the device entrance port during manufacturing and insertion, while the flexible transition portion accommodates angular variations and prevents kinking when the device rotates or moves relative to the catheter axis.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter design incorporates a gradual change in flexibility parameters along its length. Near the entrance port, the catheter has higher flexibility to accommodate angular variations, while maintaining the required entry angle precision. This parameter gradient allows the catheter to adapt to device movement without kinking, while still achieving precise angular alignment during insertion.

Inventive Principle:
Principle #35Parameter changes

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 effectively reduces kinking and pinching, ensuring consistent fluid flow and minimizing the risk of tissue damage or device injury during medical procedures.

Implementation Method 1

a strain relief member supporting a portion of a length of the catheter at the delivery end, where the strain relief member increases a stiffness of the length to reduce kinking at the length when a force is applied on the catheter that deflects the catheter relative to the medical device

Methodology Applied
Scientific EffectStiffness: Elasticity

Implementation Method 2

a stylet configured to fit within a lumen of the catheter... where a flexibility of the stylet tip is greater than a remainder of the stylet such that the stylet tip forms a flexible contact interface wherein the flexibility of the stylet contact interface reduces damage to the reservoir or the catheter

Methodology Applied
Scientific EffectFlexibility: Elasticity

Data Source

PatentUS11497900B2Enhanced fluid delivery system
Publication Date: 2022.11.15 ALLURION TECHNOLOGIES INC
  • US11497900B2 patent drawing
  • US11497900B2 patent drawing
  • US11497900B2 patent drawing

AI summary

Methods and devices related to fluid delivery catheters and more particularly relates to catheters used to deliver fluid to medical devices and/or position medical devices.