Fluid Delivery Apparatus Two-Stage Force Profile Microneedle
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Solution Overview
Problem
Current methods for administering triptans, such as sumatriptan, for migraines and cluster headaches face challenges including variable delivery rates, air bubbles, and difficulty in self-administration, leading to inconsistent pharmacokinetic parameters like Tmax, AUC, and Cmax.
Innovation Solution
A fluid delivery apparatus with a controller assembly featuring a two-stage force profile, utilizing a microneedle array and a cartridge assembly to ensure consistent delivery of sumatriptan, allowing for precise control of pharmacokinetic parameters by changing the force profile during administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If conventional needle delivery is used, then a large quantity of medicine can be delivered at one time, but it creates a spike in bioavailability and causes pain
Solution Approach 1:
The patent segments the medicine delivery process into multiple microneedles (array of needles) that deliver medicine simultaneously but in distributed amounts, converting a single large spike into multiple smaller deliveries. This segmentation approach maintains total delivery quantity while stabilizing bioavailability by distributing the load across multiple penetration points.
Solution Approach 2:
The patent employs a bias assembly with biasing members that dynamically adjust force applied to the plunger during medicine delivery. This dynamic force application controls the rate and pattern of medicine flow through the microneedles, preventing abrupt spikes in bioavailability while ensuring complete delivery of the prescribed quantity.
2Reliability
If transdermal delivery apparatus is used, then medicine can be delivered at a substantially constant rate, but placement and force variation affects microneedle penetration consistency
Solution Approach 1:
The bias assembly acts as a self-service mechanism that automatically compensates for variations in placement and applied force. The biasing members generate the necessary force to drive the plunger and maintain consistent medicine flow rates regardless of external force variations, making the system self-regulating and reducing operator skill requirements.
Solution Approach 2:
The system incorporates implicit feedback through the bias assembly's force-profile control mechanism. The biasing members are configured to apply force in a controlled manner that responds to resistance changes during penetration, automatically adjusting to maintain consistent delivery rates even when initial placement conditions vary.
3Reliability
If air bubbles are present in the medicine, then delivery through microneedles is affected, but eliminating air bubbles completely is difficult
Solution Approach 1:
The cartridge assembly design incorporates preliminary anti-action measures against air bubble interference. The sealed cartridge construction and fluid pathway design prevent air bubble formation and entrapment before delivery begins, addressing the air bubble problem proactively rather than requiring complex post-formation removal mechanisms.
Solution Approach 2:
The system extracts or removes air bubbles from the delivery pathway through the cartridge assembly design. The sealed construction and fluid flow path configuration actively exclude air bubbles from entering the microneedle array, effectively taking out the harmful element before it can interfere with delivery consistency.
4Manufacturing precision
If variable pressure is supplied to the medicine, then delivery quantity through each microneedle is not constant, but maintaining constant pressure reduces delivery adaptability
Solution Approach 1:
The bias assembly enables controlled parameter changes in the force profile applied to medicine delivery. By configuring the biasing members with specific force profiles, the system can adjust delivery parameters to achieve uniform quantity distribution across microneedles while maintaining the capability to adapt to different delivery requirements through parameter modification.
Solution Approach 2:
The system applies local quality control by ensuring each microneedle receives appropriate force and flow conditions for uniform delivery. The bias assembly's force profile is distributed across the microneedle array in a manner that optimizes individual needle performance while maintaining overall system adaptability for different delivery scenarios.
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
The apparatus achieves faster Tmax, higher Cmax, and AUC, providing quicker and more effective relief for migraines and cluster headaches while allowing for self-administration.
Implementation Method 1
The bias assembly includes a first biasing member having a first force profile and a second biasing member having a second force profile
Data Source
AI summary
A method for administering a medicament suitable for treating a migraine or cluster headache to a patient in need thereof includes placing a mounting surface of a fluid delivery apparatus with the medicament in contact with at least a portion of the skin of said patient. A flow rate of the medicament from the fluid delivery apparatus is adjusted such that the medicament is delivered to the patient for at least a predetermined time period. The fluid delivery apparatus includes a controller assembly having a body component defining an axis and a plunger component slidably coupled to the body component. The plunger is positionable between a first position in which the plunger is nearest to the body component and a second position in which the plunger component is furthest from the body component. A bias assembly is positioned between the body component and the plunger component. The bias assembly is configured to apply a two stage force profile to the plunger component. Also disclosed is a method for administering sumatriptan to a patient in need thereof such that the Cmax, Tmax and AUC are within predetermined, therapeutically effective values.