Sterile Patch Pump Segmentation and Thermal Isolation
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Solution Overview
Problem
Commercially available wearable patch pumps for biologic medication delivery are expensive, require proprietary cartridges, and cause patient discomfort due to refrigeration needs.
Innovation Solution
A cost-effective, self-contained patch pump that allows for the use of standard off-the-shelf drug cartridges, minimizes refrigeration-related discomfort, and includes features like user-controlled flow, visual indicators, and wireless communication for monitoring and safety mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If proprietary biologic cartridges are used in patch pumps, then manufacturing precision and reliability are improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The device is divided into two distinct modules: a sterile disposable cartridge containing the biologic and needle, and a reusable pump body. This segmentation allows the complex sterile components to be pre-packaged and sealed, improving reliability while reducing the complexity of the reusable pump system.
Solution Approach 2:
A sterile barrier membrane acts as an intermediary between the non-sterile pump body and the sterile cartridge contents. This intermediary allows fluid transfer while maintaining sterility, enabling the use of standard manufacturing processes for the pump body without compromising biologic delivery reliability.
2Adaptability or versatility
If manual transfer of biologic is required in patch pump, then adaptability is improved, but loss of time and manufacturing precision are worsened
Solution Approach 1:
The biologic is pre-filled into the cartridge under sterile conditions during manufacturing, and the needle is pre-attached. This preliminary action eliminates the need for manual transfer during patient use, reducing time loss while maintaining adaptability through the universal cartridge design that can accommodate different biologic types.
3Temperature
If refrigeration is implemented in patch pump, then temperature control is improved, but object-generated harmful factors increase
Solution Approach 1:
The refrigeration function is extracted from the wearable patch pump and placed in an external portable refrigerator. This separation allows the patch pump to maintain a comfortable temperature against the skin while the external device provides necessary refrigeration, eliminating patient discomfort from cold.
Solution Approach 2:
An adhesive liner acts as an intermediary thermal barrier between the refrigerated cartridge and the patient's skin. This intermediary insulates the cold components, allowing temperature control functionality while preventing harmful cold contact with the patient.
4Reliability
If sterilized needle insertion mechanism is used, then reliability is improved, but ease of manufacture is worsened
Solution Approach 1:
The needle insertion mechanism is segmented into a sterile disposable cartridge assembly and a reusable pump body. The sterile components are pre-assembled and sealed together, maintaining sterility reliability while simplifying manufacturing by separating sterile and non-sterile assembly processes.
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 affordable, self-administered biologic delivery with reduced patient discomfort and improved operational safety and monitoring, using a sterilized needle insertion mechanism and thermal isolation to manage cold storage effectively.
Implementation Method 1
a base that affixes to a patient's skin
Implementation Method 2
thermal isolation to manage cold storage effectively
Data Source
AI summary
An apparatus and method for the aseptic delivery of a biologic medication in a wearable form factor. The apparatus and method allow for standard off-the-shelf drug cartridges to be utilized without compromising the sterility of the biologic. Further, by utilizing a two part assembly, manufacturing costs are minimized.