Enhanced Drive Assembly for Real-Time Fluid Delivery Feedback
Legal Citation
Summary of the Inventive Concept
An improved drive assembly for drug delivery systems that provides real-time feedback on fluid delivery, enabling safer and more efficient injections.
Background and Problem Solved
The original patent disclosed a drive assembly for a drug delivery system, which, while effective, lacked real-time feedback on fluid delivery. This limitation can lead to inaccurate dosing and potential patient harm. The new inventive concept addresses this limitation by integrating a sensor to detect the plunger member's position, enabling real-time feedback and improved injection safety.
Detailed Description of the Inventive Concept
The enhanced drive assembly comprises a plunger member having a first position and a second position axially spaced from the first position. The plunger member is configured to engage and move a stopper within a container. A sensor, such as an optical sensor, is integrated into the drive assembly to detect the position of the plunger member. This sensor enables real-time feedback on the delivery of the fluid, allowing for adjustments to be made during the injection process. The drive assembly can be configured to provide real-time feedback on the delivery of the fluid to the patient, and the speed of delivery can be adjusted based on the position of the plunger member.
Novelty and Inventive Step
The integration of a sensor to detect the plunger member's position and provide real-time feedback on fluid delivery is a novel and non-obvious improvement over the original patent. This inventive step enables safer and more efficient injections, addressing a critical limitation of the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different types of sensors, such as capacitive or inductive sensors, or the integration of the sensor into the plunger member itself. Variations could also include the use of different materials or designs for the plunger member and sensor.
Potential Commercial Applications and Market
The enhanced drive assembly has significant commercial potential in the medical device industry, particularly in the area of drug delivery systems. The real-time feedback capability can improve patient safety and reduce the risk of inaccurate dosing, making it an attractive solution for pharmaceutical companies and healthcare providers.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical device engineering, specifically drug delivery systems and injection device mechanisms, focusing on precision fluid transfer and mechanical actuation
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer with expertise in mechanical design, sensor integration, and medical device development, typically holding a master's degree with 3-5 years of experience in medical device design and fluid delivery technologies
Obviousness Rationale
A PHOSITA would recognize that integrating a sensor into a drive assembly to monitor plunger position is a predictable solution for improving injection precision and safety. The source patent's drive assembly provides a clear mechanical foundation that naturally suggests adding feedback mechanisms. The technical implementation of a position-detecting sensor represents an incremental improvement using standard engineering techniques available in the medical device field.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,769 |
|---|---|
| Title | Drive assembly and spacer for drug delivery system |
| Assignee(s) | Becton, Dickinson and Company |