Piercing Device Asymmetric Tip Blister Puncture Flap Control
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Solution Overview
Problem
Existing dosage forms for delivering pharmaceuticals via spray or mist often face challenges in ensuring precise delivery and maintaining sterility, with issues such as puncture flaps interfering with the spray pattern and potential contamination.
Innovation Solution
A crushable blister dosage form with an internal piercing mechanism, featuring a dome-shaped design and a piercing nozzle with an oval cross-section and nipple-shaped tip, which minimizes puncture flap formation and ensures controlled spray geometry and sterility until use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a piercing device is used to deliver pharmaceuticals through a crushable blister, then precise delivery and sterility are achieved, but puncture flaps may form and interfere with spray pattern
Solution Approach 1:
The piercing device employs an asymmetric tip geometry with a rounded leading edge and a tapered trailing edge. This asymmetric design causes the blister material to deform and split in a controlled manner, with the rounded leading edge initiating the puncture and the tapered trailing edge guiding the material away from the delivery channel, thereby minimizing puncture flap formation that would otherwise interfere with the spray pattern
Solution Approach 2:
The piercing tip features a rounded or curved leading edge rather than a sharp angular point. This curvature allows the tip to gradually deform the blister material during penetration, creating a cleaner puncture path and reducing the formation of large flaps. The curved geometry distributes stress more evenly during insertion, resulting in less material interference with the subsequent spray delivery
2Productivity
If the blister is crushed with sufficient force to drive the dosage form against the piercing mechanism, then the contents are forced out through the piercing device, but control of spray geometry becomes challenging
Solution Approach 1:
The piercing device incorporates a flexible or resilient delivery channel that can dynamically adjust to the forces applied during blister crushing. The channel maintains its structural integrity under high pressure while allowing controlled deformation, ensuring that the spray geometry remains consistent even as the blister is crushed with varying forces. This dynamic responsiveness enables both high delivery speed and precise spray control
Solution Approach 2:
The device design allows for optimization of spray parameters such as droplet size, spray angle, and flow rate by adjusting the geometry of the piercing tip and delivery channel. By carefully selecting parameters like tip diameter, channel length, and wall thickness, the system can achieve desired spray characteristics while maintaining the ability to deliver contents rapidly under crushing forces
3Reliability
If an internal piercing mechanism is used within the dome-shaped blister, then sterility is maintained until use, but the device complexity increases
Solution Approach 1:
The piercing device integrates the piercing tip and delivery channel into a single monolithic component that is directly embedded within the dome-shaped blister. This merged design eliminates the need for separate piercing mechanisms or additional assembly steps, maintaining sterility by keeping all components sealed within the blister until use, while simultaneously reducing overall device complexity through component consolidation
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 solution enables precise and controlled delivery of pharmaceuticals in a desired volume and spray pattern, maintaining sterility and maximizing the therapeutic benefit while minimizing contamination risks.
Implementation Method 1
a measured amount of a pharmaceutical composition contained in a crushable ampoule, blister or other dosage form that is forced against a penetrating device during use, to pierce the dosage form and release the contents
Implementation Method 2
crushed by a plunger with sufficient force to drive the dosage form against a piercing mechanism, piercing the dosage form and forcing the liquid or solid contents from the dosage form
Implementation Method 3
delivering a stream, drops, particles, spray or mist in a desired volume and spray geometry to a human or non-human animal
Data Source
AI summary
Devices for delivery of medical compositions in either liquid or powder form include a piercing device for piercing a flexible sheet material in which when contained in a flexible blister dosage form, the piercing device serves as a delivery channel for compositions contained in the blister. The device is configured to reduce or inhibit puncture flap interference with the delivered spray or mist by forming a substantial non-contact drape in the material prior to puncture.