Coiled Surgical Device Packaging for Sterile Dilator Insertion

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Solution Overview

Problem

Existing packaging for surgical devices like sheaths and dilators often requires separate sterile packaging, which can lead to deformation, damage, and contamination risks due to their length, making it cumbersome and increasing the likelihood of becoming non-sterile during preparation for procedures.

Innovation Solution

A coiled package design that allows the dilator to be inserted into the sheath without removing the sheath from its packaging, maintaining both in a protected coiled state within a sterile package, reducing the risk of damage and contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If separate sterile packaging is used for long dilators and sheaths, then the devices can be individually protected, but the package sizes become very long and hard to handle, and the devices risk becoming non-sterile during preparation

Engineering Contradiction:

Improvesterility maintenanceVSAvoidpackage handling

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The packaging system nests the dilator within the sheath, both contained within a single sterile package. The dilator is positioned inside the sheath lumen, allowing both devices to be stored compactly while maintaining individual sterility. This nested configuration eliminates the need for separate long packages while preventing contamination during the insertion procedure.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If separate sterile packaging is used for long dilators and sheaths, then individual protection is provided, but the devices risk deformation or damage to the valve during handling

Engineering Contradiction:

Improvedevice protectionVSAvoidpackaging configuration

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The sheath is nested within the dilator packaging structure, with the dilator positioned inside the sheath. This nested arrangement provides mechanical support and protection for both devices, preventing valve deformation while maintaining a relatively simple single-package configuration rather than multiple separate packages.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The packaging system transitions from linear separate packages to a three-dimensional nested configuration. The dilator and sheath are arranged concentrically within the package, utilizing vertical and radial space rather than only linear length, thereby reducing overall package length while maintaining device protection.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Reliability

If the dilator and sheath are combined in separate packaging, then sterility is maintained, but the insertion process becomes cumbersome and time-consuming

Engineering Contradiction:

Improvesterility maintenanceVSAvoidpreparation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The dilator is pre-positioned inside the sheath within the sterile package before sterilization. This preliminary arrangement eliminates the need for separate manipulation and insertion steps during the procedure. The medical practitioner simply needs to remove the combined assembly from the package, and the dilator is already in its final position within the sheath, ready for immediate use.

Inventive Principle:

Principle #10Preliminary action

4Ease of operation

If long dilators and sheaths are laid out for preparation, then insertion is facilitated, but contact with non-sterile surfaces increases the risk of contamination

Engineering Contradiction:

Improveinsertion facilitationVSAvoidcontamination risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The dilator remains nested within the sheath throughout the preparation process, with both devices contained within the sterile package until the moment of use. This nested configuration prevents contact with non-sterile surfaces while still allowing the practitioner to access and insert the combined assembly easily, eliminating the need to lay out separate long devices.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS10507073B2Package assembly for sterile and convenient insertion of dilator into sheath

Publication Date: 2019.12.17 TERUMO MEDICAL CORP

AI summary

A package assembly for an elongate surgical device in which two or more elongate surgical devices are secured and oriented in a coiled configuration so that a distal end of a first elongate surgical device may be inserted into a proximal end of a second elongate surgical device. In this assembly, the elongate surgical devices remain in a protected coiled state in the package while in the sterile field and so that a medical professional may prep the elongate surgical devices without removing from the package prior to use. In this package assembly, the elongate surgical devices reduce space required and eliminate the risk of damage to the devices and/or the chance of the elongate surgical devices become unsterile prior to use.