United States Patent 7,284,474: A Detailed Analysis
Overview of the Patent
United States Patent 7,284,474, titled "Piston-pumping system having o-ring seal properties," was granted to address specific needs in the field of medical devices, particularly in the precise measurement and pumping of pharmaceutical liquids. Here is a detailed analysis of the scope, claims, and patent landscape surrounding this invention.
Scope of the Invention
Purpose and Objectives
The patent describes a piston-pumping system designed to ensure substantially gas-free measurement and pumping of predetermined quantities of liquids, especially pharmaceutical liquids containing oxidation-prone ingredients. The primary objectives include:
- Preventing gas from entering the measuring chamber to maintain the accuracy of the liquid quantity.
- Ensuring the pharmaceutical liquid is not mixed with oxygen, air, or other gases during the measuring or pumping process.
- Overcoming the disadvantages of existing pumping systems in medical devices[1].
Key Components and Functionality
Piston Pumping System
The system consists of a chamber with a liquid inlet and outlet, and a piston connected to the chamber. The piston moves in a stroke-like manner along its longitudinal axis to draw in and deliver liquid in predetermined quantities. The chamber is designed to have a fill volume ranging from 1 microliter to 1 ml, with preferred volumes between 5 microliters to 100 microliters[1].
Sealing Mechanism
The system utilizes sealing materials, such as o-rings, suitable for food or drug use to improve the sealing of the piston against the diffusion of air or other gases from the outer environment into the liquid. This ensures that the liquid remains uncontaminated by external gases[1].
Intake System
The intake system, which includes the liquid inlet and the supply system connected to it, is designed to bring liquid from a storage system into the chamber. The supply system may include pipes or tubes with cross-sections less than 1 mm and a non-return valve to prevent backflow into the storage container[1].
Claims of the Patent
Main Claims
The patent includes several claims that define the scope of the invention:
- A piston pumping system for substantially gas-free measurement and/or pumping of liquids.
- A system with a chamber and a piston connected to it, allowing for the precise measurement and delivery of liquid.
- The use of sealing materials to prevent gas diffusion into the liquid.
- The integration of an intake system with a non-return valve to ensure one-way flow of the liquid[1].
Dependent Claims
Dependent claims further specify the details of the system, such as:
- The preferred fill volumes of the chamber.
- The construction of the storage system as a flexible container that collapses as liquid is removed.
- The optional integration of the intake system within the pump piston[1].
Patent Landscape
Related Patents
The patent is part of a broader landscape of patents related to medical devices and pharmaceutical delivery systems. For example, patents like US7896264 and US9027967, which are associated with similar medical devices, highlight the complexity and innovation in this field[4].
Litigation and Infringement
The '474 patent has been involved in several legal disputes, particularly regarding generic versions of pharmaceutical products. Defendants in these cases have sought to assert that their products do not infringe on the '474 patent, while plaintiffs argue for infringement and seek injunctive relief to prevent the commercial manufacture, use, or sale of these generic products before the patent expires[2][5].
Expiration and Maintenance
The '474 patent has already expired, with its maintenance fees last paid in 2019. This expiration marks the end of the exclusive rights granted to the patent holder, allowing for the potential development of generic or similar products without infringement concerns[4].
Impact on Medical Devices
Application in Medical Devices
The piston-pumping system described in the '474 patent is crucial for medical devices such as transdermal therapeutic systems, which require precise and gas-free delivery of pharmaceutical formulations. This technology ensures the integrity of the pharmaceutical liquid, which is essential for patient safety and the efficacy of the treatment[1].
Industry Standards
The invention sets a standard for the design and functionality of mini- or micropumps in medical devices, emphasizing the importance of gas-free environments in pharmaceutical delivery. This standard influences the development of subsequent medical devices and pumping systems[1].
Conclusion
The United States Patent 7,284,474 addresses a critical need in the medical device industry by providing a piston-pumping system that ensures the accurate and gas-free measurement and delivery of pharmaceutical liquids. The patent's scope, claims, and involvement in litigation highlight its significance and the ongoing innovations in this field.
Key Takeaways
- The patent describes a piston-pumping system for gas-free measurement and pumping of pharmaceutical liquids.
- It uses sealing materials like o-rings to prevent gas diffusion.
- The system is designed for precise delivery in medical devices such as transdermal therapeutic systems.
- The patent has been involved in litigation regarding generic pharmaceutical products.
- The patent has expired, allowing for the development of similar products.
FAQs
Q: What is the primary purpose of the United States Patent 7,284,474?
A: The primary purpose is to provide a piston-pumping system for substantially gas-free measurement and pumping of predetermined quantities of pharmaceutical liquids.
Q: How does the sealing mechanism in the patent work?
A: The sealing mechanism uses materials like o-rings to prevent the diffusion of air or other gases into the liquid being measured or pumped.
Q: What types of medical devices can this patent be applied to?
A: This patent can be applied to medical devices such as transdermal therapeutic systems and other devices requiring precise and gas-free delivery of pharmaceutical formulations.
Q: Is the '474 patent still in effect?
A: No, the '474 patent has expired, with its last maintenance fees paid in 2019.
Q: Why is preventing gas diffusion important in this context?
A: Preventing gas diffusion is crucial to maintain the integrity and safety of the pharmaceutical liquid, ensuring it does not contain appreciable amounts of gas that could endanger patient health.
