Two-Part Fluid Dispenser Gamma Sterilization Segmentation
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Solution Overview
Problem
Existing medicament dispensers for ambulatory patients face challenges in sterilizing fluid flow channels without affecting the medicament in the reservoir, and there is a need for a device that can initiate infusion therapy quickly and easily without medical professional assistance, with the ability to control fluid flow rates and be user-friendly and cost-effective.
Innovation Solution
A two-part fluid dispensing apparatus comprising a fluid reservoir assembly and a separate fluid delivery and control assembly, where the fluid flow passageways can be sterilized using gamma ray techniques without affecting the medicament, utilizing a compressible, expandable stored energy source, such as a constant force spring, and a flow control mechanism to manage the medicament delivery at a uniform rate.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional gamma ray sterilization is applied to the entire device including the reservoir, then the fluid flow channels are effectively sterilized, but the medicament in the reservoir is adversely affected
Solution Approach 1:
The device is divided into two separate assemblies: a sterilizable delivery assembly containing the fluid flow channels, and a non-sterilizable reservoir assembly containing the medicament. This segmentation allows the delivery assembly to undergo gamma ray sterilization while the reservoir with medicament is excluded from the sterilization process, preventing medicament degradation while ensuring sterilization effectiveness.
Solution Approach 2:
The reservoir containing the medicament is extracted and separated from the delivery assembly before sterilization. The reservoir is removed from the sterilization field, allowing the delivery assembly to be sterilized without exposing the medicament to harmful gamma rays. The two parts are then connected just before use.
2Ease of manufacture
If the device is designed as a single integrated unit, then manufacturing is simpler, but sterilization cannot be performed without affecting the medicament
Solution Approach 1:
The device is segmented into two separately manufacturable assemblies: a reservoir assembly and a delivery assembly. Each can be manufactured independently using standard processes, and then connected through a simple interface. This segmentation enables the delivery assembly to be sterilized separately while maintaining manufacturing simplicity through modular design.
3Device complexity
If the fluid delivery assembly is integrated with the reservoir, then the device structure is simplified, but the fluid flow channels cannot be sterilized independently
Solution Approach 1:
The device structure is segmented into a reservoir assembly and a delivery assembly that can be disconnected. The delivery assembly containing the fluid flow channels is separated from the reservoir, allowing independent sterilization of the delivery assembly through gamma ray irradiation while the reservoir remains unsterilized to protect the medicament.
4Reliability
If the device requires professional medical assistance for initiation, then safety is improved, but ease of operation deteriorates
Solution Approach 1:
The device is prepared in advance with the reservoir filled and sealed, and the delivery assembly pre-sterilized and connected to the reservoir through a simple patient-activated mechanism. This preliminary preparation allows the patient to initiate infusion therapy quickly and easily at home without requiring professional medical assistance, while maintaining safety through pre-engineered safety features.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables effective sterilization of fluid flow channels, allows for quick and easy initiation of infusion therapy, provides precise control over fluid flow rates, and is compact, lightweight, reliable, and inexpensive to manufacture, making it suitable for home care use by ambulatory patients.
Implementation Method 1
a stored energy source that is provided in the form of a substantially constant-force, compressible-expandable wave spring that provides the force necessary to continuously and uniformly expel fluid from the device reservoir
Implementation Method 2
the fluid flow passageways of the fluid delivery and control assembly can be effectively sterilized using conventional gamma ray sterilization techniques without adversely affecting the medicament contained within the fluid reservoir
Data Source
AI summary
A dispensing device for dispensing medicaments to a patient that is made up of first and second stand-alone, interconnectable assemblies. The first of these assemblies comprises a fluid reservoir assembly that houses a fluid reservoir defining component while the second assembly comprises a fluid delivery and control assembly that includes a novel flow control means that functions to control the flow of medicinal fluid from the fluid reservoir of the first assembly toward the patient via a plurality of fluid flow control passageways. Because the stand-alone fluid delivery and control assembly is initially totally separate from the fluid reservoir assembly of the apparatus, the fluid flow passageways of the fluid delivery and control assembly can be effectively sterilized using conventional gamma ray sterilization techniques without adversely affecting the medicament contained within the fluid reservoir of the apparatus.