Subcutaneous Infusion Pump for Precise Levodopa Delivery
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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, as they are designed for conditions like diabetes and do not accommodate the unique dosage and symptom requirements of these patients.
Innovation Solution
A medicament delivery device with a reusable part and disposable part, featuring a cannula insertion mechanism that reduces the force required for skin puncture, multiple cannulas for simultaneous delivery, and a simple attachment scheme, allowing for both basal and bolus delivery modes, and equipped with sensors for physiological monitoring and automatic operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional infusion pumps designed for diabetes treatment are used, then the delivery mechanism is established, but the device is inappropriate and ineffective for Parkinson's Disease dosage and symptom requirements
Solution Approach 1:
The device enables parameter changes in delivery volume and dosage configuration to accommodate different disease requirements. The reservoir and drive mechanism can be adjusted to deliver the specific volumes and dosages needed for Parkinson's Disease patients, unlike fixed-parameter diabetes pumps
Solution Approach 2:
The infusion pump is designed with multi-functionality to serve different patient needs. It can deliver both continuous basal doses and intermittent bolus doses, and the system can be configured for different medicament volumes and delivery rates, making it adaptable across different therapeutic requirements
2Measurement precision
If manual delivery by patient or medical personnel is used, then device complexity is reduced, but delivery precision and control are insufficient
Solution Approach 1:
The device incorporates automatic drive mechanisms that eliminate the need for manual operation. The pump system self-regulates medicament delivery through integrated drive components, sensors, and control mechanisms, providing precise delivery without requiring manual intervention while maintaining manageable complexity through automation
Solution Approach 2:
The infusion pump includes sensors and control systems that monitor delivery parameters and provide feedback to maintain precision. This feedback mechanism ensures accurate dosage delivery while the system automatically adjusts to maintain control, reducing the need for complex manual monitoring
3Ease of operation
If high force is applied for skin puncture, then cannula insertion is achieved, but patient effort and discomfort increase
Solution Approach 1:
The device performs preliminary actions to facilitate smooth cannula insertion. The insertion mechanism is designed to prepare the delivery path and reduce resistance before the cannula contacts the skin, minimizing the force needed during actual insertion and reducing patient discomfort
Solution Approach 2:
The device uses an intermediary mechanism between the drive system and the cannula insertion point. This intermediary component mediates the insertion process by distributing and reducing the insertion force, making the process easier and more comfortable for the patient while still achieving effective penetration
4Adaptability or versatility
If single cannula delivery is used, then device simplicity is maintained, but delivery flexibility for basal and bolus modes is limited
Solution Approach 1:
The delivery system is segmented into multiple cannulas that can operate independently or in coordination. This segmentation allows the device to deliver different medicament types or dosages through separate pathways, enabling both continuous basal delivery and intermittent bolus delivery modes without requiring a completely complex reconfiguration
Data Source
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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 reusable 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.