Passive Catheter Dilation for Precise Skin-Site Insertion

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Solution Overview

Problem

Current catheter insertion techniques require multiple instruments and manual dilation, leading to increased complexity, time, risk of infection, and undesired tissue deflection, often resulting in over-dilation.

Innovation Solution

A catheter with a distal section featuring a tapered junction and dilation structures, such as protrusions or helices, that dilate the skin insertion site minimally and accurately, reducing the need for additional instruments and minimizing tissue deflection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual dilation techniques using separate hardened components and skin nick are used, then tissue dilation can be achieved, but device complexity increases, insertion time increases, and risk of infection increases

Engineering Contradiction:
Improverisk of infectionVSAvoidnumber of instruments
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the dilation function with the catheter insertion device itself by incorporating dilation structures (protrusions or helices) directly onto the distal section of the catheter. This eliminates the need for separate dilation instruments, reducing device complexity and the number of instruments required while maintaining effective tissue dilation capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The catheter is designed to perform multiple functions: the distal section with dilation structures serves both as the insertion point and as the dilation mechanism. The same catheter structure that enters the tissue also performs the dilation function, making the device multi-functional and eliminating the need for separate specialized instruments.

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

2Productivity

If manual dilation techniques with separate instruments are used, then tissue dilation can be achieved, but insertion time increases

Engineering Contradiction:
Improveinsertion timeVSAvoidnumber of instruments
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The dilation function is merged into the catheter insertion device, allowing dilation and insertion to occur in a single continuous action rather than requiring separate steps with different instruments. This integration directly reduces insertion time while simplifying the overall procedure.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The dilation structures are pre-configured on the catheter before insertion begins. As the catheter is inserted, the dilation structures automatically perform the dilation action in advance of the main catheter body, preparing the tissue pathway without requiring separate preliminary dilation steps.

Inventive Principle:
Principle #10Preliminary action

3Manufacturing precision

If increased pushing forces are used to dilate tissue, then dilation can be achieved, but tissue deflection increases and over-dilation occurs

Engineering Contradiction:
Improvedilation precisionVSAvoidpushing forces
Core Design Contradiction:
Manufacturing precisionVSForce

Solution Approach 1:

The dilation structures are localized to the distal section of the catheter, concentrating the dilation action at the precise insertion point. This localized approach allows controlled, precise dilation without requiring excessive force, preventing tissue deflection and over-dilation of surrounding areas.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The helical or protrusion-based dilation structures provide a curved, progressive dilation mechanism that distributes force more evenly through the tissue. This curved geometry allows the catheter to dilate tissue gradually and controlledly rather than through abrupt forceful insertion, improving precision and preventing over-dilation.

Inventive Principle:
Principle #14Spheroidality (Curvature)

4Reliability

If separate hardened components are used for dilation, then dilation can be achieved, but the necessity of skin nick increases

Engineering Contradiction:
Improvenecessity of skin nickVSAvoidnumber of instruments
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The dilation function is combined with the catheter insertion device, eliminating the need for separate hardened dilation components. This integration reduces the number of instruments required and decreases the necessity for skin nick procedures while maintaining effective tissue dilation capability.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12403286B2Passive dilation in catheter insertion systems
Publication Date: 2025.09.02 BARD ACCESS SYSTEMS INC
  • US12403286B2 patent drawing
  • US12403286B2 patent drawing
  • US12403286B2 patent drawing

AI summary

Disclosed herein is a catheter, which in some embodiments includes a distal section configured to enter a skin insertion site. The distal section can include a tapered junction having one or more dilation structures configured to dilate the skin insertion site. The distal section can further include a distal portion extending from a distal end of the tapered junction, the distal portion having a diameter smaller than a proximal portion of the catheter. In combination, the tapered junction, the one or more dilation structures, and the specific actions of the user urging the catheter into the insertion site can result in an improved fit of the catheter in the insertion site.