Multi-dose fluid path sterility via segmentation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional medical connectors and fluid path elements face challenges in maintaining sterility during use, as they can become contaminated upon removal from pre-sterilized packages and during connection processes, especially in non-sterile environments, posing risks to multi-patient systems.
Innovation Solution
A multi-dose disposable system featuring a multi-use fluid path set and a series of single-use fluid path sets, with a foldable casing and a manifold with check valves, ensures sterility by maintaining a sterile fluid path from fluid containers to the patient, allowing for sequential use and minimizing exposure to non-sterile surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional medical connectors are removed from pre-sterilized packages for use, then they can be connected and used in medical procedures, but they become contaminated by airborne particles and non-sterile surfaces
Solution Approach 1:
The fluid path system is divided into multiple segments: a multi-use fluid path set that remains connected to the injector, and multiple single-use fluid path sets that are sequentially connected and disconnected. Each single-use set is sterile when removed from packaging, used for one patient, then discarded, preventing cross-contamination while maintaining ease of operation
Solution Approach 2:
The system employs disposable single-use fluid path sets that are discarded after one use. These inexpensive, single-use components eliminate the need to sterilize connectors between patients, as each new patient receives a fresh, sterile fluid path set, solving the contamination problem while maintaining operational simplicity
2Productivity
If a single fluid path set is reused across multiple patients, then resource utilization improves, but sterility cannot be maintained between patients
Solution Approach 1:
The fluid path system is segmented into a reusable multi-use portion and disposable single-use portions. The multi-use fluid path set remains connected to the injector and is reused across multiple patients, while the single-use fluid path sets are discarded after each patient, maintaining sterility without sacrificing resource utilization of the expensive injector components
Solution Approach 2:
The single-use fluid path sets act as intermediaries between the multi-use fluid path set and the patient. These disposable intermediaries transfer the fluid while maintaining sterility, allowing the multi-use portion to be reused without direct contact with multiple patients, thus preserving both sterility and resource utilization
3Adaptability or versatility
If connections are made in non-sterile environments, then operational flexibility improves, but sterility of the fluid path is compromised
Solution Approach 1:
The single-use fluid path sets are pre-sterilized and packaged in sterile containers before use. The sterile packaging maintains sterility during transport and storage, and the connection process is designed to maintain sterility until the moment of use, allowing connections to be made in non-sterile environments while preserving sterility of the fluid path
Solution Approach 2:
The disposable single-use fluid path sets eliminate the need for sterile environments during connection, as each set is sterile when removed from packaging and discarded after one use. This allows operational flexibility in non-sterile environments while maintaining sterility through the use of fresh, sealed, single-use components for each patient
Data Source
Figure 1
Figure 2
Figure 3
AI summary
A multi-dose disposable fluid delivery system includes at least one fluid container, a multi-use fluid path set, and a plurality of single-use fluid path sets. The at least one fluid container has a connection port configured for fluidly connecting with a first end of the multi-use fluid path set. The second end of the multi-fluid path set is configured for fluidly connecting to a fluid injection apparatus. The plurality of single-use fluid path sets is connected in sequence to define a fluid path extending from a first single-use fluid path set to a last single- use fluid path set. Each of the plurality single-use fluid path sets has a first end and a second end. The first end of the first single-use fluid path set is configured for connecting to a delivery line. The second end of the last single-use fluid path set is configured for connecting to the injection apparatus.