Delayed Drug Delivery Lockout Mechanism
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Solution Overview
Problem
Patients undergoing chemotherapy, particularly those receiving chemotherapy agents like fludarabine, mitoxantrone, and cyclophosphamide, face challenges in self-administering colony stimulating factors such as G-CSF due to timing constraints, requiring separate medical visits which are inconvenient and burdensome, especially when experiencing acute side effects.
Innovation Solution
A drug delivery system with a lockout mechanism that prevents use until a preselected time period has elapsed, combined with an output element to notify the patient when the system is ready for use, allowing for delayed and timely administration of drugs like G-CSF as a single bolus, reducing the need for additional medical visits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a syringe is used for self-administration, then the patient can deliver the drug manually, but the patient requires manual needle insertion and plunger advancement which is challenging for individuals with limited experience or dexterity
Solution Approach 1:
The device enables self-service by allowing the patient to automatically insert the needle and deliver the drug through automated mechanisms. The automated injector performs needle insertion and plunger advancement without requiring manual dexterity or experience from the patient, while still maintaining patient autonomy in administering their own medication.
Solution Approach 2:
The patent replaces manual mechanical operations (needle insertion by hand, plunger advancement by hand) with automated mechanical systems. The automated injector uses motorized or spring-loaded mechanisms to perform these tasks automatically, reducing the skill requirement while maintaining the same functional outcome.
2Ease of operation
If automated drug delivery devices are used, then manual needle insertion and plunger movement are automated, but the devices are limited in their ability to assist the patient with complying with a prescribed treatment regimen
Solution Approach 1:
The device achieves multi-functionality by combining automated injection capabilities with treatment regimen management features. The automated injector not only performs the physical injection but also includes features to track dosing schedules, remind patients of upcoming injections, and monitor compliance with the prescribed treatment regimen, making it a versatile tool for both automation and regimen management.
Solution Approach 2:
The patent incorporates feedback mechanisms that monitor and communicate with the patient about their treatment progress. The device can provide feedback through reminders, dosing tracking, and compliance monitoring, creating a closed-loop system that actively assists the patient in following their treatment regimen while maintaining automation of the injection process.
3Reliability
If patients return to healthcare facility for drug administration, then professional administration is ensured, but separate medical visits are inconvenient and burdensome
Solution Approach 1:
The device enables patients to perform self-administration at home, eliminating the need to return to healthcare facilities for routine injections. The automated injector provides reliable administration comparable to professional administration while allowing patients to perform the procedure independently in the comfort of their own environment, saving time and reducing burden.
4Reliability
If a lockout system is added to ensure timely drug delivery, then the drug is delivered at the optimal time, but the device complexity increases
Solution Approach 1:
The lockout system implements preliminary action by preventing device operation until a predetermined time window has elapsed. The system is pre-configured with the appropriate timing parameters, and the lockout mechanism automatically engages to prevent premature use. This ensures timely drug delivery at the optimal post-chemotherapy interval while using a relatively simple timing-based control mechanism rather than complex monitoring systems.
Data Source
AI summary
Systems and methods for delayed delivery of a drug are disclosed. A drug delivery system may include a delivery member for insertion into a patient and a reservoir configured to receive a volume of a drug. An energy source may be activatable by the patient to actuate the reservoir to deliver the drug to the patient as a single bolus. A lockout system may be configured to have a locked state, wherein the lockout system prevents movement of the delivery member and/or activation of the energy source, and an unlocked state, wherein the lockout system permits movement of the delivery member and/or activation of the energy source. The lockout system may be configured to automatically change from the locked state to the unlocked state after a preselected time period has elapsed. An output element may generate a detectable output after the preselected time period has elapsed for notifying the patient.