Surgery – Means and methods for collecting body fluids or waste material
Reexamination Certificate
2001-06-15
2004-05-11
Huson, Gregory L. (Department: 3751)
Surgery
Means and methods for collecting body fluids or waste material
C604S319000, C141S059000, C141S007000
Reexamination Certificate
active
06733481
ABSTRACT:
INTRODUCTION
Bodily fluids, at one time considered to pose no significant hazards, are now understood to be biohazardous. The hazards extend to care providers as well as patients since the fluids can transfer pathogenic compounds such as viruses and bacteria. In response to this heightened awareness of risk, mitigation of such biohazards is becoming a standard of care in the medical profession.
Mitigation schemes depend on the mode or manner of possible exposure. In the context of medical surgery, for example, the exposure may occur from contact with a patient's undiluted bodily fluids or from contact with bodily fluids diluted in irrigation liquids that are used during surgery. The fluids are typically in macroscopic form. However, exposure may also occur from contact with small aerosols containing bodily fluids. Aerosols may be generated during the surgery by, for example, the action of surgical tools. Other seemingly risk-free actions, such as pouring liquid waste into drains during or after surgery, may also produce aerosols. Once an aerosol is generated, small droplets of fluid migrate throughout the surgery environment and pose a distributed hazard.
The most advanced surgery facilities may be well equipped to mitigate many modes of exposure to biohazardous fluids. However, many environments in which surgery is performed are not well equipped. In fact, many surgeries are performed in an environment that is more like an office than a hospital. For example, arthroscopic surgery on the shoulder or knee is commonly performed outside of a hospital in a medical practitioner's office. During such a surgery, irrigation fluid is infused into the joint by a gravity-feed system. A resulting mixture of irrigation fluid and the patient's bodily fluids is commonly drained from the surgery site and collected in an open bucket or receptacle placed on the floor. Eventually, the contents of the receptacle are poured into a sewer drain.
Such common practices can and should be improved according to a higher standard of care that includes mitigation of biohazard exposure modes. However, prior art containment systems that might be used are not simple and economical since they typically include expensive, bulky vacuum pumps and other hardware. Thus, many medical practitioners continue procedures that expose both patients and care providers to biohazards. To transition to a higher standard of care, simple, economical, closed containment systems for biohazardous fluids are needed. Such systems are complementary alternatives to more elaborate and expensive prior art devices in the marketplace.
SUMMARY
This invention is a containment system for biohazardous fluids. In an embodiment, the containment system includes a container having a first membrane and a second membrane coupled together to enclose a containment volume. The first membrane has a characteristic property of being permeable to gases and impermeable to liquids and aerosols. Differing embodiments have a first membrane impermeable to objects having a size greater than 10 micrometers, or 1 micrometer, or 0.1 micrometer. Suitable materials for the first membrane include polymers such as polytetrafluoroethylene (PTFE).
The second membrane has a characteristic property of being impermeable to gasses and liquids and includes an inlet port configured to receive a tube. In certain embodiments, the second membrane may be transparent to visible light. The inlet port may have several membranes that self-seal about the surface of a member piercing through the elastic membrane. In other embodiments, the inlet port includes a diaphragm, which may be fabricated from a silastic material. The diaphragm may be formed from a plurality of leaves, or overlapping semi-circular disk portions.
Other embodiments include a single-use liner assembly and a rigid, reusable receptacle coupled to and substantially enclosing the liner assembly. The single-use liner assembly includes a biohazard container. In certain embodiments, the second membrane of the container may have an outlet port and the liner assembly may include an elastic band. Both the reusable receptacle and the liner assembly may be transparent to visible light. Further embodiments include a lid that is securable to the reusable receptacle to completely enclose the liner assembly.
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Huson Gregory L.
Huynh Khoa
Ow Melody
Wilson Sonsini Goodrich & Rosati
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