Medical Device Holder for Rotational Orientation Control
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Solution Overview
Problem
Elongate medical devices such as catheters often become twisted or kinked during sterilization and storage, rendering them unusable due to non-uniform shape changes caused by processes like ethylene gas sterilization and heat application, which existing packaging systems fail to prevent.
Innovation Solution
A packaging system that includes an elongate holder with a lumen to align and maintain the rotational orientation of the medical device's shaft, preventing radial rotation and twisting by aligning specific cross-sectional areas of the shaft within the holder.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the medical device is packaged in a coiled configuration to save space for sterilization and storage, then the packaging compactness is improved, but the device becomes twisted or kinked during sterilization or storage
Solution Approach 1:
The holder is inserted inside a sterilization pouch, creating a nested structure where the holder protects the medical device while the pouch provides sterilization containment. This nested arrangement allows the device to maintain its orientation during sterilization and storage without requiring excessive packaging volume.
Solution Approach 2:
The holder is designed with alignment features (flats, ridges, grooves) that preliminarily orient the medical device in the correct rotational position before sterilization. This preliminary action ensures the device maintains proper orientation throughout the sterilization process and storage, preventing twisting or kinking while allowing compact packaging.
2Productivity
If automated feeding is used to insert the medical device into the package, then the packaging efficiency is improved, but the device becomes twisted or kinked due to improper handling
Solution Approach 1:
The holder acts as an intermediary device between the automated feeding system and the medical device. The holder's structural features (flats, ridges, grooves) guide and constrain the device during automated insertion, ensuring proper orientation is maintained throughout the feeding process without requiring complex automated handling mechanisms.
Solution Approach 2:
The holder incorporates localized structural features (flats at specific positions, ridges, grooves) that provide orientation control at critical locations along the device. These localized features ensure proper rotational orientation during automated feeding while maintaining overall packaging efficiency.
3Reliability
If ethylene gas sterilization and heat application are used to sterilize the medical device, then the sterilization effectiveness is improved, but the device material relaxes and twists causing non-uniform shape changes
Solution Approach 1:
The holder is designed with alignment features that preemptively counteract the twisting forces that will occur during ethylene gas sterilization and heat treatment. The flats, ridges, and grooves create mechanical constraints that oppose the material's natural tendency to relax and twist, maintaining device geometry throughout the sterilization process.
Solution Approach 2:
The holder serves as a protective intermediary between the sterilization environment (ethylene gas and heat) and the medical device. It shields the device from the deforming effects of sterilization while still allowing the sterilization process to effectively treat the device.
4Adaptability or versatility
If the device shaft is allowed to rotate radially during packaging, then the packaging flexibility is improved, but the lumen alignment is lost making wire guide insertion difficult
Solution Approach 1:
The holder incorporates asymmetric features (flats, ridges, grooves) that break the rotational symmetry of the device shaft. This asymmetric design prevents radial rotation by creating a unique fit between the holder's asymmetric features and the shaft's corresponding features, ensuring lumen alignment is maintained while still allowing flexible packaging.
Data Source
AI summary
Methods of packaging a medical device to orient at least a portion of the medical device and a medical device packaging assembly are provided. A method includes providing an elongate holder having a lumen extending through at least a portion of the holder and providing the medical device including an elongate shaft where the shaft includes a first cross-sectional area having a rotational orientation and a second cross-sectional area having a second rotational orientation. The method further includes aligning the first and second areas so that the first and second rotational orientations are aligned along a longitudinal region of the shaft and inserting at least a portion of the medical device into the lumen of the holder Radial rotation of the first area with respect to the second area is substantially prevented.