Introducer Sheath Transition to Prevent Tissue Catching

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Solution Overview

Problem

The Seldinger technique for introducing central venous catheters is time-consuming and involves multiple medical devices, leading to potential patient trauma and infection risks due to device handling and tissue catching on the introducer sheath, especially with slotted needles that excise a portion of the bevel, requiring additional insertion force.

Innovation Solution

Introducers with tissue-easing transitions, featuring a longitudinal recess and taper in the sheath tip to ease tissue over the distal end without catching, reducing insertion force and minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a slotted needle is used to rapidly deploy an access guidewire, then venous access is established quickly, but tissue bridges over the slot and catches on the distal end of the introducer sheath, requiring additional insertion force

Engineering Contradiction:

Improvespeed of venous accessVSAvoidinsertion force

Core Design Contradiction:

ProductivityVSForce

Solution Approach 1:

The patent removes the slot entirely from the needle structure. Instead of having a longitudinal slot that excises the heel portion of the bevel, the needle is formed as a solid, continuous structure without any slot, thereby eliminating the source of tissue catching while maintaining the ability to deploy the guidewire through the introducer mechanism

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent incorporates a tapered distal end on the introducer sheath that is designed to ease tissue over it during insertion. This taper acts as a cushioning feature that prevents tissue from catching on the sheath edge, reducing the insertion force required before the needle even penetrates the tissue

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Ease of operation

If the heel portion of the bevel is excised to allow slot extension through the needle tip, then guidewire deployment is facilitated, but tissue catching occurs on the distal end of the introducer sheath

Engineering Contradiction:

Improveguidewire deploymentVSAvoidtissue catching and damage

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent removes the slot and the associated heel portion excision entirely. The needle is constructed as a solid structure without any longitudinal opening, eliminating the geometric discontinuity that causes tissue to bridge and catch on the introducer sheath during insertion

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs a composite introducer assembly where the solid needle structure works in conjunction with a tapered sheath design. The combination of the solid needle (without slot) and the tapered sheath creates a synergistic effect that facilitates both guidewire deployment and smooth tissue penetration without catching

Inventive Principle:

Principle #40Composite materials

3Reliability

If multiple medical devices are used in the Seldinger technique, then venous access can be established, but the number of steps increases and patient trauma risk increases

Engineering Contradiction:

Improvevenous access establishmentVSAvoidnumber of medical devices and steps

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple functions into a single integrated introducer device. The introducer integrates the needle, the introducer sheath, and the guidewire deployment mechanism into one unified device, eliminating the need for separate handling of multiple devices and reducing the number of procedural steps while maintaining reliable venous access

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The introducer device is designed with multi-functionality, serving as both the puncture instrument, the introducer for the catheter, and the guidewire deployment mechanism. This universal design reduces device complexity by consolidating functions that traditionally required separate devices into a single multi-functional unit

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20250375594A1Introducers and Assemblies Thereof with Tissue-Easing Transitions

Publication Date: 2025.12.11 BARD ACCESS SYSTEMS INC

AI summary

An introducer can include an introducer needle and an introducer sheath having a transition therebetween that eases tissue over a distal end of the introducer sheath without catching tissue thereon tissue despite an excised portion of the introducer needle. The introducer needle can include a needle shaft having a longitudinal needle slot extending from a proximal portion of the needle shaft through a distal needle tip, which results in an excised portion of a heel of a bevel of the needle tip. The introducer sheath can include a sheath body and a tapered sheath tip. The sheath body can be over the needle shaft sealing the needle slot thereunder but for a sheath-body opening in a proximal portion of the sheath body for an access guidewire. The introducer can include the transition from the bevel of the needle tip to at least the taper of the sheath tip.