Subcutaneous Medicament Delivery With Modular Pump and Cannula Insertion
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Solution Overview
Problem
Current infusion pumps are inadequate for delivering liquid formulations of levodopa/carbidopa, which are necessary for treating Parkinson's Disease and other CNS disorders, due to differences in drug dosage and symptom profiles compared to diabetes treatment, requiring a specialized device for effective subcutaneous delivery.
Innovation Solution
A medicament delivery device with a reusable part containing a drive component and control unit, and a disposable part with a reservoir and cannula insertion mechanism, designed for easy use, featuring a filling station, vial adapter, and various delivery modes, including subcutaneous, intravenous, and intramuscular, to accommodate different medicaments and patient needs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If current infusion pumps designed for diabetes treatment are used, then liquid medicament delivery is achieved, but the device is inappropriate and ineffective for Parkinson's Disease due to different dosage volumes and symptom profiles
Solution Approach 1:
The device modifies key parameters including reservoir capacity (larger than diabetes pumps), drive mechanism force output (higher for viscous levodopa formulations), and dosing control algorithms (adjusted for Parkinson's dosage volumes and intermittent bolus delivery patterns). These parameter changes enable the pump to effectively deliver Parkinson's medications while maintaining reliability for the specific patient population.
2Reliability
If a specialized device for Parkinson's Disease is developed, then effectiveness for CNS disorders is improved, but device complexity increases compared to standard infusion pumps
Solution Approach 1:
The device is divided into modular components: a reusable pump unit containing the drive mechanism and control electronics, and disposable infusion sets including reservoirs and cannulas. This segmentation allows the complex specialized features (drive mechanism, control unit) to be confined to the reusable portion while simplifying the disposable portion, thereby managing overall device complexity while maintaining effectiveness.
Solution Approach 2:
The reusable pump unit is designed with universal interfaces and adjustable parameters that can accommodate different reservoir types and medication formulations (both continuous and intermittent dosing). This multi-functionality reduces the need for multiple specialized devices while maintaining reliability for Parkinson's treatment.
3Device complexity
If manual delivery by patient or medical personnel is used, then device simplicity is maintained, but medicament delivery precision and control are reduced compared to infusion pumps
Solution Approach 1:
The pump incorporates automatic dosing algorithms that calculate and deliver precise medication volumes based on programmed parameters, eliminating the need for manual measurement and administration. The device self-regulates flow rates, handles reservoir priming, and manages dosing schedules, thereby maintaining simplicity of operation while achieving high delivery precision required for Parkinson's treatment.
4Stability of the object's composition
If infusion pumps deliver continuous flow (basal dose), then steady medicament administration is achieved, but flexibility for intermittent dosing (bolus dose) is reduced
Solution Approach 1:
The drive mechanism and control system are designed to dynamically switch between continuous basal dosing mode and intermittent bolus dosing mode. The system can adjust flow rates in real-time, transitioning from steady continuous flow to controlled intermittent pulses, thereby maintaining stability during basal delivery while providing flexibility for bolus doses when needed for Parkinson's symptom management.
Data Source
AI summary
An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson's Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station.