Subcutaneous Infusion Pump With Low-Force Cannula Insertion
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Solution Overview
Problem
Current infusion pumps designed for diabetes treatment are inadequate for patients with Parkinson's Disease and other CNS disorders due to differences in drug dosage and symptom profiles, lacking appropriate devices for subcutaneous delivery of liquid levodopa/carbidopa formulations.
Innovation Solution
Development of a medicament delivery device with a reusable part and disposable part, featuring a cannula insertion mechanism that reduces insertion force, multiple cannula configurations, and automated delivery modes for precise and controlled subcutaneous delivery of fluid medicaments, including levodopa/carbidopa, suitable for Parkinson's Disease treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional infusion pumps are used for subcutaneous delivery, then delivery precision is improved, but device complexity and inappropriateness for Parkinson's Disease increases
Solution Approach 1:
The device is divided into a reusable pump unit and a disposable infusion set, allowing the complex pump mechanism to be reused while the disposable portion handles patient-specific requirements. This segmentation resolves the contradiction by concentrating precision delivery mechanics in the reusable unit while simplifying the disposable interface for Parkinson's patients.
Solution Approach 2:
The pump unit is designed to handle multiple medicament types and delivery modes (continuous and intermittent), making it universally applicable to different patient needs. This multi-functionality allows a single device to address various Parkinson's treatment requirements without increasing overall system complexity for the user.
2Device complexity
If manual delivery by patient or medical personnel is used, then device complexity is reduced, but delivery precision and control deteriorates
Solution Approach 1:
The device enables patient self-administration through simplified controls and automatic delivery mechanisms. The pump automatically calculates and delivers precise doses based on pre-programmed parameters, eliminating the need for manual measurement while keeping the interface simple enough for patients with Parkinson's to operate independently.
Solution Approach 2:
Manual mechanical delivery actions are replaced with automated electronic control systems that precisely regulate medicament flow. The electronic pump mechanism substitutes for manual syringe operation, providing consistent precision delivery while maintaining ease of use through automated dose calculation and administration.
3Measurement precision
If infusion pumps with multiple components are used, then delivery precision is improved, but ease of operation deteriorates for patients with Parkinson's Disease
Solution Approach 1:
The device separates complex pump mechanics into a reusable unit from simple patient interface components. The disposable infusion set requires minimal manipulation (attachment/detachment), while the reusable pump handles all complex dosing calculations and delivery precision, resolving the contradiction between precision and ease of operation.
Solution Approach 2:
Dosing parameters, delivery schedules, and precision calibration are pre-configured in the pump unit before patient use. The device is pre-programmed with treatment protocols, eliminating the need for patients to manually adjust settings during operation, thus maintaining precision while simplifying patient interaction.
4Adaptability or versatility
If standalone pump units with remote positioning are used, then device functionality is improved, but patient mobility and convenience deteriorates
Solution Approach 1:
The pump unit and infusion set are designed to work as an integrated portable system that can be worn close to the patient's body. The combination maintains full pump functionality while enabling patient mobility through flexible positioning options, resolving the contradiction between device capability and patient convenience.
Solution Approach 2:
The device transitions from fixed remote positioning to flexible wearable positioning, allowing the pump to be placed in multiple locations on or near the patient's body. This dimensional flexibility maintains full functionality while adapting to patient mobility needs and comfort preferences.
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.