Breath-Actuated Dry Powder Inhaler with Bistable Flap and Piercer Blade

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Solution Overview

Problem

Current dry powder inhalers face challenges such as bulkiness, complexity in assembly, non-robust structures, and inconsistent dose delivery across varying inspiratory capacities, making them difficult to use, especially for pediatric and geriatric patients, and often result in inefficient treatment due to coordination requirements and erratic dose emission.

Innovation Solution

A breath-actuated dry powder inhaler with a dose-ring subassembly, breath-actuated mechanism, and dose opening mechanism that includes a piercer blade with tangs to cut slits in foil packets, allowing for easy inhalation of accurate doses, featuring a bistable biasing spring and latch system for controlled dose release, and an audible signal for dosage indication, ensuring consistent and hygienic use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If traditional pMDI is used, then drug delivery speed is high, but patient coordination difficulty increases and treatment effectiveness decreases

Engineering Contradiction:
Improvedrug delivery speedVSAvoidpatient coordination
Core Design Contradiction:
SpeedVSEase of operation

Solution Approach 1:

The DPI device performs the actuation function automatically when the patient generates sufficient inspiratory flow, eliminating the need for manual coordination between hand and lung. The device self-activates through the patient's own breathing effort, making it self-serving and significantly easier to operate for pediatric and geriatric patients.

Inventive Principle:
Principle #25Self-service

2Manufacturing precision

If DPI requires high inspiratory effort for activation, then dose emission quality improves, but ease of operation decreases for patients with limited inspiratory capacity

Engineering Contradiction:
Improvedose emission qualityVSAvoidinspiratory effort requirement
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The device incorporates a flow sensor that detects inspiratory flow rate and triggers dose emission at optimized flow thresholds. This parameter-based control ensures accurate dose delivery while accommodating patients with varying inspiratory capacities, including pediatric and geriatric populations who may not generate high flow rates.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The breath-actuated mechanism with flow sensing provides real-time feedback on patient inspiratory effort, automatically adjusting the timing and triggering of dose emission. This feedback loop ensures that the device responds appropriately to the patient's actual breathing capacity, maintaining dose accuracy while reducing the required inspiratory effort.

Inventive Principle:
Principle #23Feedback

3Ease of manufacture

If refillable DPI device is developed, then cost effectiveness improves, but device complexity increases

Engineering Contradiction:
Improvecost effectivenessVSAvoidrefillable mechanism
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The DPI device is divided into modular components: a reusable main body containing the motor, flow sensor, and control electronics, and replaceable drug reservoirs or cartridges. This segmentation allows the expensive electronic components to be reused while only the consumable drug supply is replaced, significantly improving cost-effectiveness while keeping the refill mechanism relatively simple.

Inventive Principle:
Principle #1Segmentation

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 inhaler provides a simple, robust, and cost-effective solution for delivering accurate doses across different inspiratory capacities, improving treatment efficacy by ensuring consistent drug delivery and reducing waste, while being reusable and easy to assemble.

Implementation Method 1

the BAM being primed by rotation of the mouthpiece cover from a substantially closed to a substantially open position such that breath induced low pressure opens the BAM flap

Methodology Applied
Scientific EffectPressure drop: Pressure Drop

Implementation Method 2

a bistable biasing spring holding the BAM flap in the substantially closed position, the BAM being primed by rotation of the mouthpiece cover from a substantially closed to a substantially open position such that breath induced low pressure overcomes the bistable biasing spring to allow opening of the BAM flap wherein the bistable spring acts to move the BAM flap to the open position

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3086829B1A dry powder inhaler
Publication Date: 2020.03.25 GLENMARK PHARMACEUTICALS LTD
  • EP3086829B1 patent drawingFigure 1
  • EP3086829B1 patent drawingFigure 2~3
  • EP3086829B1 patent drawingFigure 4~5

AI summary

The present invention relates to a breath-actuated dry powder inhaler, wherein a breath actuated mechanism comprises a flap (11) movable from a substantially closed position to a substantially open position and a bistable biasing spring (10) holding the flap in the substantially closed position. The breath actuated mechanism is primed by rotation of a mouthpiece cover (17) from a substantially closed to a substantially open position such that on inhalation breath induced low pressure overcomes the bistable biasing spring to allow opening of the flap wherein the bistable spring acts to move the flap to the open. During the flap travel from the closed to the open position, the movement of the flap forces a latch (21) retaining an energized dose opening mechanism to be disengaged, thereby triggering dose opening by the piercer blade (3), wherein the dose opening mechanism is energized by the opening of the mouthpiece cover and is held in a latched position until disengaged by movement of the flap. The piercer blade which cuts a slit in the sealed foil packet moves through a lower foil, the dose pocket and an upper foil.