Retractable-Blade Tissue Dilator for Safe Catheter Site Entry

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Solution Overview

Problem

Existing methods for integrating skin nicking and tissue dilation at an insertion site for catheter placement are unsafe due to uncontrolled spring-loaded blades, leading to procedural inefficiencies and errors.

Innovation Solution

A tissue-cutting dilator with retractable or rotatable blades integrated into the dilator design, allowing for safe and controlled tissue cutting and dilation using a cap mechanism to retract blades during insertion, ensuring proper alignment and preventing blade jams.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If spring-loaded blades are used to integrate skin nicking and tissue dilation, then procedural time is reduced, but safety deteriorates due to uncontrolled blade operation

Engineering Contradiction:
Improveprocedural timeVSAvoidsafety
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The blade is designed to be dynamically controllable, transitioning from a static fixed blade to a dynamically adjustable blade that can be deployed and retracted as needed. The blade carrier moves along the dilator body, allowing the blade to extend through the side wall for cutting and then retract for safe dilation, providing both speed and control.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates feedback through the controlled deployment mechanism where the blade is only exposed when intentionally advanced by the operator. The blade carrier system provides tactile and visual feedback, allowing the clinician to control blade exposure precisely, thus maintaining safety while achieving integrated nicking and dilation in one device.

Inventive Principle:
Principle #23Feedback

2Productivity

If blades are integrated into the dilator for simultaneous nicking and dilation, then procedural efficiency is improved, but device complexity increases

Engineering Contradiction:
Improveprocedural efficiencyVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The device is segmented into distinct functional components: the dilator body for dilation, the blade carrier for blade control, the blade itself for cutting, and the cap for protection. This segmentation allows each component to perform its specific function efficiently while maintaining overall system manageability and reducing operational complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The blade is nested within the blade carrier, which is in turn nested within or attached to the dilator body. The cap covers the entire assembly for protection during storage and transport. This nested structure consolidates multiple functions into a compact integrated device without significantly increasing operational complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Productivity

If the blade extends through the dilator side wall for tissue cutting, then cutting effectiveness is improved, but risk of tissue damage increases

Engineering Contradiction:
Improvecutting effectivenessVSAvoidtissue damage
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The blade is designed to extend only partially through the side wall, exposing just the necessary portion for effective cutting. This partial exposure provides sufficient cutting capability for skin nicking while limiting the blade's exposed length to minimize the risk of excessive tissue damage or accidental injury during the procedure.

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentEP4426213B1Tissue-cutting dilators
Publication Date: 2025.12.24 BARD ACCESS SYSTEMS INC
  • EP4426213B1 patent drawingFigure 1~3
  • EP4426213B1 patent drawingFigure 4~5
  • EP4426213B1 patent drawingFigure 6~7

AI summary

A tissue-cutting dilator can include an elongate dilator body (102), a dilator tip (104), a plurality of retractable blades (122, 124), and a cap (108). The dilator body can include a plurality of longitudinal guide slots along a distal portion of the dilator body. The dilator tip can be formed in the distal portion of the dilator body or coupled to a distal end of the dilator body. The dilator tip can include a plurality of blade slots. The blades can be disposed in the dilator body. The blades can be configured to extend through the blade slots in a ready-to-dilate state of the dilator to cut tissue around an insertion site upon insertion into the insertion site. The cap can be slidably disposed over the dilator body. The cap can cover the dilator tip in at least the ready-to-dilate state of the dilator.