Bistable Member Manual Drug Release Control
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Solution Overview
Problem
Conventional implantable drug delivery devices lack the ability for patients to actively control drug release, requiring removal and reinsertion for on-off functionality, and often rely on complex electronic systems that are costly and difficult to manufacture.
Innovation Solution
An implantable drug delivery device with a bistable member that allows manual control of drug release through a reversible fluidic pathway, enabling patients to turn drug delivery on and off without electronic power, using a bistable member that can switch between open and closed states to permit or prevent drug diffusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If passive continuous drug release is used (e.g., Nexplanon), then the device structure is simple and manufacturing is easy, but the patient cannot activate or deactivate drug release without physician intervention
Solution Approach 1:
The device transitions from a static passive release system to a dynamic controllable system by incorporating a bistable member that can switch between open and closed states. This mechanical switch allows the fluidic pathway to be dynamically controlled, enabling the patient to activate or deactivate drug release as needed while maintaining overall device simplicity.
Solution Approach 2:
The device enables self-service operation by allowing the patient to control drug release independently without requiring physician intervention. The manual activation mechanism empowers the patient to make decisions about their own treatment, switching the bistable member between states to start or stop drug delivery as desired.
2Ease of operation
If device removal and reinsertion is required for on-off functionality, then active control capability is achieved, but the procedure is not trivial and requires physician services
Solution Approach 1:
The device separates the control function from the implantation/removal procedure by incorporating a distinct bistable member that can be manually actuated. This segmentation allows the on-off control to be achieved through a simple mechanical action rather than requiring the complex procedure of device removal and reinsertion, maintaining ease of manufacture while providing active control.
Solution Approach 2:
The device transitions from a static passive release system to a dynamic controllable system by incorporating a bistable member that can switch between open and closed states. This mechanical switch allows the fluidic pathway to be dynamically controlled, enabling the patient to activate or deactivate drug release as needed while maintaining overall device simplicity.
3Adaptability or versatility
If actively controlled drug release with power and electronics is used, then on-demand and programmed schedule release is achieved, but the design is complicated and manufacturing is expensive
Solution Approach 1:
The device replaces complex electronic control systems with a simple mechanical bistable member that switches between open and closed states. This mechanical substitution eliminates the need for power sources, electronics, and associated complexity while still providing controllable drug release capability. The bistable member's mechanical nature makes the device simpler to manufacture and more reliable.
Solution Approach 2:
The device uses a simple, inexpensive mechanical bistable member instead of expensive electronic components. This approach prioritizes simplicity and manufacturability over advanced programmable features, creating a cost-effective solution that provides basic on-demand control without the complexity and expense of electronic systems.
4Device complexity
If manual control without electronic power is implemented, then cost and complexity are reduced, but active control capability must be achieved
Solution Approach 1:
The device transitions from a static passive release system to a dynamic controllable system by incorporating a bistable member that can switch between open and closed states. This mechanical switch allows the fluidic pathway to be dynamically controlled, enabling the patient to activate or deactivate drug release as needed while maintaining overall device simplicity.
Solution Approach 2:
The device enables self-service operation by allowing the patient to control drug release independently without requiring physician intervention. The manual activation mechanism empowers the patient to make decisions about their own treatment, switching the bistable member between states to start or stop drug delivery as desired.
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 patients to manually control drug release over extended periods without electronic power, providing a cost-effective and user-friendly solution for managing drug delivery, allowing for extended periods of drug release without the need for physician intervention.
Implementation Method 1
drug can diffuse to release the drug from the device
Data Source
AI summary
Abstract of the Disclosure Implantable drug delivery devices and methods of making and using the same are provided. The implantable drug delivery devices permit selective activation and deactivation of drug delivery while subcutaneously implanted in a patient without the use of electronic equipment or power. The devices include a bistable member that has two stable states. In a first stable state, the bistable member does not close off a fluidic pathway between a drug reservoir and a drug release aperture, thereby allowing drug release from the device. In a second stable state, the bistable member closes off or narrows the fluidic pathway, thereby reducing or preventing drug release from the device. A patient or another person can reversibly change the bistable member between the first and second stable states by applying pressure on the patient's skin over the site of implantation and/or manipulating the device through the patient's skin at the site of implantation.