Cartridge Dispensing Device Sterile Interface Assembly
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Solution Overview
Problem
Current medical substance dispensing devices require costly and time-consuming sterilization and assembly processes in a sterile environment, which increases production costs and time, especially when assembling thousands of units daily.
Innovation Solution
A sterilization and assembly apparatus and method that selectively sterilize only the contact portions of the cartridge and dispensing device, using a UV sterilizing device and form-fitting interfaces to maintain sterility while reducing the need for a fully sterile assembly environment, allowing pre-assembly of the cartridge to the device before packaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the cartridge and dispensing device are sterilized in a sterile environment before assembly, then sterility of the medical substance is guaranteed, but assembly time and production costs increase significantly
Solution Approach 1:
The system is divided into sterile and non-sterile zones separated by a sterile barrier. The sterile cartridge is assembled in a non-sterile environment by connecting through a sterile interface (needle piercing seal), eliminating the need for a fully sterile assembly chamber while maintaining sterility where required.
Solution Approach 2:
A sterile barrier (seal) acts as an intermediary between the sterile cartridge and the non-sterile dispensing device. The needle pierces this barrier to establish fluid connection, allowing assembly in non-sterile environment while preserving sterility of the medical substance pathway.
2Reliability
If a fully sterile environment is used for assembly, then sterility is maintained, but production costs and assembly time increase
Solution Approach 1:
Sterility is applied locally only where medically necessary (inside the sealed chamber and cartridge) rather than throughout the entire assembly environment. The sterile barrier confines sterility to the fluid pathway, allowing rapid assembly outside this zone.
Solution Approach 2:
The cartridge is pre-filled and pre-sterilized separately before assembly. This preliminary sterilization allows the assembly process itself to occur rapidly in a non-sterile environment without compromising the pre-established sterility of the medical substance.
3Reliability
If the cartridge is pre-filled with medical substance, then sterility must be maintained, but assembly becomes more complex and time-consuming
Solution Approach 1:
The sterilization and filling process is extracted and performed separately on the cartridge before assembly. The completed sterile cartridge is then simply connected to the dispensing device through the sterile interface, simplifying the assembly process while maintaining sterility.
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
Significantly reduces sterilization and assembly time and costs by sterilizing only necessary components, maintaining sterility within the sealed chamber, and enabling a compact, pre-assembled dispensing device for efficient medical substance delivery.
Implementation Method 1
a UV sterilizing device (80) configured to sterilize said sealed chamber (56)
Data Source
AI summary
An apparatus (4) for sterilizing and assembling a cartridge (8) containing a medical substance to a device (12) for dispensing said medical substance, comprising: a cartridge (8) containing the medical substance to be dispensed, the cartridge being provided with a cap (24), a device (12) for dispensing said medical substance, the device being provided with at least one needle (28) configured to pierce the cap (24) of the cartridge (8) and allow the withdrawal of the medical substance from the cartridge (8), a first interface (32) that may be sealingly joined to the cap (24) of the cartridge (8) by means of the interposition of a first gasket (36), a second interface (40) joined to the dispensing device (12) near said needle (28), wherein the second interface (40) has a seal (44) that isolates the needle (28) from the external environment in a sterile volume (48), and is provided with a second gasket (52) which may be sealingly joined to the first interface (32) in order to identify a sealed chamber (56) delimited between a portion of the cap (24) facing said needle (28) and said seal (44), the second gasket (52) being external to said sterile volume (48), and a sterilizing device (80) configured to irradiate and sterilize said sealed chamber (56).