Enhanced Fluid Control Devices for Reduced Contamination in Bodily Fluid Sampling
Legal Citation
Summary of the Inventive Concept
An improved fluid control device and method for procuring bodily fluid samples with reduced contamination, featuring a primary and secondary chamber design that minimizes mixing of contaminants and enables more efficient sampling.
Background and Problem Solved
The original patent described a fluid diversion, sequestration, and/or isolation device for procuring bodily fluid samples with reduced contaminants. However, the existing design may still allow for some level of contamination due to turbulence and mixing in the sequestration chamber. The new inventive concept addresses this limitation by introducing a primary and secondary chamber design that reduces turbulence and minimizes the risk of contamination in the subsequent volume of bodily fluid.
Detailed Description of the Inventive Concept
The enhanced fluid control device features a primary chamber for receiving an initial volume of bodily fluid and a secondary chamber for receiving a subsequent volume of bodily fluid. A flow controller is configured to selectively direct the initial volume to the primary chamber and the subsequent volume to the secondary chamber, thereby reducing turbulence and minimizing the risk of contamination in the subsequent volume. The flow controller is adapted to respond to a suction force created by a negative pressure source, ensuring efficient and controlled sampling. The device may also include a valve to regulate the flow of bodily fluid between the primary and secondary chambers, further reducing the risk of backflow and contamination.
Novelty and Inventive Step
The new inventive concept introduces a novel primary and secondary chamber design that reduces turbulence and minimizes the risk of contamination in the subsequent volume of bodily fluid. This design is not obvious from the original patent and provides a significant improvement over existing fluid control devices.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include variations in the chamber design, such as using different materials or shapes to optimize flow control and minimize turbulence. Additional features, such as sensors or alarms, could be integrated into the device to enhance its functionality and user experience.
Potential Commercial Applications and Market
The enhanced fluid control device has significant commercial potential in the healthcare industry, particularly in the fields of diagnostic testing and medical research. The device's ability to reduce contamination and improve sampling efficiency could lead to increased adoption and revenue growth in these markets.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical device engineering, specifically fluid sampling and contamination control technologies for diagnostic and clinical applications. Requires expertise in fluid dynamics, medical device design, and microbial contamination prevention strategies
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device designer with advanced degree, 3-5 years professional experience, familiar with fluid control mechanisms, sterile sampling techniques, and medical device design principles
Obviousness Rationale
A PHOSITA would recognize that the PTD's primary and secondary chamber design represents a predictable variation of the source patent's fluid sequestration approach. The core technical problem of reducing contamination during fluid sampling remains consistent, with the PTD offering a straightforward engineering solution using known fluid control principles. The modifications represent incremental design improvements that would be apparent to a skilled practitioner seeking to optimize bodily fluid sampling techniques.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,321 |
|---|---|
| Title | Fluid control devices and methods of using the same |
| Assignee(s) | Magnolia Medical Technologies, Inc. |