Enhanced Three-Position Plungers for Improved Syringe Assemblies
Legal Citation
Summary of the Inventive Concept
The present inventive concept discloses direct improvements and enhancements to three-position plungers, film-coated plungers, and related syringe assemblies, focusing on increased safety, efficiency, and sterility.
Background and Problem Solved
The original patent disclosed three-position plungers for pre-filled syringes, but these plungers had limitations, such as friction, sticking, and potential contamination. The new inventive concept addresses these limitations by introducing self-lubricating coatings, protective coatings, integrated locking mechanisms, tapered surfaces, and sterilizing coatings, ensuring improved shelf-life, ease of use, and safety.
Detailed Description of the Inventive Concept
The enhanced three-position plunger features a self-lubricating coating, reducing friction and sticking between the plunger and barrel. Additionally, a protective coating prevents corrosion and maintains container closure integrity. An integrated locking mechanism ensures the plunger remains in a predetermined position, preventing accidental movement. A tapered surface facilitates smooth plunger movement, reducing the risk of jamming. Furthermore, a sterilizing coating provides an additional layer of protection against contamination. These enhancements enable improved syringe assemblies with enhanced safety, efficiency, and sterility.
Novelty and Inventive Step
The new claims introduce novel and non-obvious improvements to the original three-position plunger design, including self-lubricating coatings, protective coatings, integrated locking mechanisms, tapered surfaces, and sterilizing coatings. These enhancements provide a significant inventive step over the original patent, addressing specific limitations and providing improved performance, safety, and efficiency.
Alternative Embodiments and Variations
Alternative embodiments may include varying the material and thickness of the coatings, adjusting the locking mechanism's design, or incorporating additional features, such as sensors or indicators, to further enhance the syringe assembly. Variations may also include adapting the enhanced plunger design for use in other drug delivery devices, such as cartridges or auto-injectors.
Potential Commercial Applications and Market
The enhanced three-position plunger has significant commercial potential in the pharmaceutical and medical device industries, particularly in the development of pre-filled syringes, cartridges, and auto-injectors. The improved safety, efficiency, and sterility of these devices will appeal to manufacturers and users seeking reliable and high-quality products.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical device engineering, specifically drug delivery systems and syringe component design, focusing on plunger mechanisms and surface treatments for medical syringes
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer with expertise in medical device design, materials science, and pharmaceutical packaging, possessing knowledge of polymer coatings, friction reduction techniques, and syringe assembly optimization
Obviousness Rationale
A person of ordinary skill would recognize that the PTD's variations represent predictable engineering improvements to the source patent's three-position plunger design. The disclosed enhancements such as self-lubricating coatings, integrated locking mechanisms, and protective surfaces are logical extensions of existing syringe technology. These modifications address known limitations in plunger performance and would be considered routine design optimization for a skilled practitioner in medical device engineering.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,771 |
|---|---|
| Title | Three-position plungers, film coated plungers and related syringe assemblies |
| Assignee(s) | SIO2 MEDICAL PRODUCTS, LLC |