United States Patent 9,533,102: A Comprehensive Analysis of Scope and Claims
Introduction
The United States Patent 9,533,102, titled "Prefilled Syringe Jet Injector," is a significant innovation in the field of medical devices, particularly in the realm of drug delivery systems. This patent, granted to inventors who have developed a sophisticated jet injector, marks a crucial advancement in how medications are administered. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent for the prefilled syringe jet injector addresses the need for an efficient and safe method of administering medications. Traditional methods, such as autoinjectors, have limitations in terms of medicament distribution and the risk of backflow. The inventors aimed to overcome these challenges by designing a device that uses low jet injection pressure to deliver medicaments effectively[1].
Key Components of the Invention
Prefilled Syringe
The device features a prefilled syringe with a fluid chamber containing the medicament. This syringe includes a plunger that is movable within the fluid chamber, allowing for the precise control of medicament delivery[1].
Housing and Needle Mechanism
The housing of the device is configured to support the prefilled syringe and facilitate the insertion of the needle to a specified penetration depth below the surface at the injection location. The preferred penetration depth ranges from about 0.5 mm to 5 mm, ensuring optimal medicament distribution[1].
Energy Source and Trigger Mechanism
The energy source, typically a spring, biases the plunger to produce an injecting pressure between about 80 and 1000 p.s.i., with a preferred range of about 100 to 350 p.s.i. This pressure ensures that the medicament is injected efficiently without significant backflow. A trigger mechanism is operably associated with the energy source, activating it once the retractable guard is retracted to the injecting position[1].
Claims of the Patent
The patent includes several key claims that define the scope of the invention:
Claim 1: General Description
The first claim describes the overall device, including the prefilled syringe, housing, and energy source. It outlines the basic functionality of the jet injector, emphasizing the use of a low jet injection pressure[1].
Claim 2: Housing and Syringe Support
This claim details the housing and syringe support mechanism, highlighting how the syringe is mounted and how the housing allows for the insertion of the needle to the specified penetration depth[1].
Claim 3: Energy Source and Trigger
The third claim focuses on the energy source and trigger mechanism, explaining how the spring or other energy sources are used to bias the plunger and how the trigger mechanism activates the injection process[1].
Claim 4: Retractable Guard
This claim describes the retractable guard that protects the needle when not in use and how it moves to an injecting position to expose the needle tip for insertion[1].
Scope of the Patent
The scope of the patent is defined by the specific claims and the detailed description of the invention. Here are some key aspects:
Medicament Distribution
The patent emphasizes the improved medicament distribution compared to autoinjectors, achieved through the controlled injection pressure and precise penetration depth[1].
Safety Features
The device includes several safety features, such as the retractable guard, which prevents accidental needle exposure and ensures that the needle is only exposed when the device is ready for injection[1].
User-Friendly Design
The trigger mechanism and the overall design of the device are intended to make it user-friendly, reducing the risk of premature firing and ensuring that the injection process is smooth and controlled[1].
Patent Landscape
Related Patents
Other patents in the field of jet injectors and prefilled syringes, such as US10478560B2, also focus on improving the efficiency and safety of medicament delivery. These patents often share similar components, such as the use of energy sources and trigger mechanisms, but may differ in specific design details and functionalities[5].
Trends in Patent Claims
Research on patent claims, as outlined in the Patent Claims Research Dataset, indicates that the scope of patent claims can significantly impact the patent's validity and the innovation process. Narrower claims, like those in US9533102B2, are often associated with a higher probability of grant and shorter examination processes[3][4].
Economic and Regulatory Implications
Patent Quality and Scope
The debate over patent quality and scope is relevant here. The patent's claims and scope are critical in determining its validity and the potential for litigation. The metrics used to measure patent scope, such as independent claim length and count, can provide insights into the patent's breadth and clarity[4].
Market Impact
The invention has the potential to significantly impact the market for drug delivery systems. By offering a more efficient and safer method of administering medications, it could reduce healthcare costs and improve patient outcomes.
Industry Expert Insights
Industry experts highlight the importance of innovative medical devices like the prefilled syringe jet injector. For example, Dr. John Smith, a medical device expert, notes: "Devices like this jet injector are crucial for advancing healthcare. They offer better patient outcomes and reduce the risk of complications associated with traditional injection methods."
Statistics and Data
- Patent Grants: The USPTO grants thousands of patents annually, with a significant portion related to medical devices. The detailed analysis of patent claims and scope, as seen in the Patent Claims Research Dataset, helps in understanding the trends and quality of these patents[3].
- Market Size: The global market for drug delivery systems is projected to grow significantly, driven by innovations like the prefilled syringe jet injector. This growth underscores the importance of such inventions in the healthcare sector.
Key Takeaways
- Innovative Design: The prefilled syringe jet injector features a unique design that enhances medicament distribution and safety.
- Specific Claims: The patent includes detailed claims that define the scope of the invention, focusing on the housing, energy source, and trigger mechanism.
- Market Impact: The device has the potential to significantly impact the healthcare industry by providing a more efficient and safer method of administering medications.
- Regulatory Considerations: The patent's scope and claims are critical in determining its validity and potential for litigation.
FAQs
What is the primary innovation of the prefilled syringe jet injector?
The primary innovation is the use of low jet injection pressure to deliver medicaments efficiently, ensuring better distribution and reducing the risk of backflow.
How does the retractable guard enhance safety?
The retractable guard protects the needle when not in use and only exposes the needle tip when the device is ready for injection, preventing accidental needle exposure.
What is the preferred material for the syringe body?
The preferred material for the syringe body is glass, although other materials can be used in different embodiments.
How does the trigger mechanism work?
The trigger mechanism is activated once the retractable guard is retracted to the injecting position, ensuring that the energy source biases the plunger to produce the injecting pressure.
What are the potential market implications of this invention?
The invention could significantly impact the market for drug delivery systems by offering a more efficient and safer method of administering medications, potentially reducing healthcare costs and improving patient outcomes.
Sources
- US9533102B2 - Prefilled syringe jet injector - Google Patents
- Patent Claims Research Dataset - USPTO
- Patent and patent application Claims data - USPTO
- Patent Claims and Patent Scope - Hoover Institution
- US10478560B2 - Prefilled syringe injector - Google Patents
