Smoke evacuation apparatus

Details Smoke evacuation apparatus Smoke evacuation apparatus

2001-10-05

2003-02-25

Peffley, Michael (Department: 3739)

Surgery

Instruments

Electrical application

C606S049000, C604S022000, C604S035000

Reexamination Certificate

active

06524307

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a smoke evacuation apparatus shaped to receive a surgical device which may create smoke, and which can be connected to a vacuum source for evacuation of smoke. More particularly, the present invention relates to a combined smoke evacuation and filter apparatus which may be disposed of after up to four hours of use, the apparatus including a unitary holder formed of elastic silicone adapted to receive surgical device which may create smoke, a suction tube carrying the power source of the device, a tubular back end piece connecting the holder to the suction tube, and a filter housing at an end of the suction tube, the filter housing containing a four stage filter and a casual liquid collector.
BACKGROUND OF THE INVENTION
Surgical smoke and aerosol, or plume, is created when energy is imparted to tissue cells during surgery. For example, when laser or electrosurgical energy is delivered to a cell, heat is created. The heat vaporizes the intracellular fluid, which increases the pressure inside the cell and eventually causes the cell membrane to burst. When this happens, a plume of smoke containing mostly water vapor is released into the atmosphere of the operating room or doctor's office. At the same time, the intense heat created chars the protein and other organic matter within the cell, and causes thermal necrosis in adjacent cells. The charring of cells, like grilling on a barbecue, releases other harmful contaminants, such as carbonized cell fragments and gaseous hydrocarbons.
Surgical smoke and aerosol is typically produced during procedures utilizing lasers and electrosurgical equipment. Other sources of smoke may be dental drill or harmonic tools. The power sources for these devices are typically electrical leads or air lines.
Research shows that both laser and electrosurgical smoke and aerosol have very similar makeup. These small particles and gases are potentially hazardous if inhaled. If they are not evacuated, they become airborne and can be inhaled.
Reports of health care workers becoming infected with HIV through injuries with sharp objects and exposure to blood and other body fluids have sparked concern about the possibility of the transmission of HIV or other bloodborne pathogens through the aerosols produced by powered surgical instruments.
Surgical smoke and aerosol generated in an open operating room environment is absorbed primarily via the respiratory tract, but the harmful components of surgical smoke and aerosol can also be absorbed by the skin and mucous membranes.
Exactly what is in surgical smoke and aerosol? The potential hazards can vary, depending primarily upon what energy source is used to create the smoke and the tissue or substance being altered or aerosolized. Generally, the composition of surgical smoke and aerosol generated by a laser or electrosurgical procedure is 95% water vapor and 5% other matter. It is this “other matter” that is potentially hazardous to the health of surgical personnel and their patients. The hazards fall into two broad categories: biological and chemical.
Potentially harmful biological components include infectious bacteria and viruses, either intact or fragmented. The potentially toxic chemicals in surgical smoke and aerosol include proven toxins, mutagens, carcinogens, and allergens. The average size of the particles contained in surgical smoke and aerosol is 0.31 microns (&mgr;m), with a range of 0.10 to 0.80 &mgr;m. This is also the most dangerous particle size, because it is the optimal size to be deposited in the lower respiratory tract. The sizes of some of the most significant human pathogens are as follows:
Hepatitis B virus, 0.042 &mgr;m
Human Immunodeficiency Virus, 0.180 &mgr;m
Human Papilloma Virus, 0.045 &mgr;m
Mycobacterium tuberculosis, 0.500 &mgr;m
The actual number of particles present in surgical smoke and aerosol can vary depending on the type of surgery and its duration, but generally range from 1,000,000 to 1,000,000,000 particles. Researchers have collected intact cells, cell parts, and intact viral DNA from the plume. Viable bacteria have been cultured from surgical plume. Mycobacteria have also been isolated in smoke plume and aerosols, including Mycobacterium tuberculosis. The viruses of greatest concern to users of lasers, electrosurgery, and powered surgical instruments are the Human Immunodeficiency Virus (HIV) and Human Papilloma Virus (HPV).
Surgical smoke and aerosol has been shown to contain a wide variety of toxic chemical byproducts. An example is toluene. This industrial solvent is irritating to the eyes, nose, and respiratory tract. Inhalation of high concentrations produces a narcotic effect, sometimes leading to coma as well as liver and kidney damage.
There seems to be no doubt that potentially harmful biological and chemical materials are contained in surgical smoke and aerosol.
Surgical smoke and aerosol occludes the vision of the surgeon and the rest of the team in both open and minimally invasive surgical procedures. This lack of visibility can lengthen the procedure, adding to costly operating room time and subjecting the patient to increased time under anesthesia. Furthermore, the smoke will hamper the performance of laser devices.
Aesthetically, the odor of surgical smoke and aerosol is extremely offensive to surgeons, nurses, patients, and others in the operating room. It attaches to hair, surgical attire, and any exposed skin surfaces. It can irritate the eyes and cause nausea and vomiting. There is also evidence that the unpleasant smell heightens patient anxiety.
Increasing recognition of the potentially infectious and toxic effects of surgical smoke and aerosol exposure has led to the development and implementation of smoke evacuation systems. Thus, the most effective way of protecting personnel and patients from inhaling the harmful components of surgical smoke and aerosol is to use a system for suctioning the smoke, which system preferably is provided with a high-efficiency filter.
A smoke evacuator is basically a vacuum pump with one or more filters designed to evacuate surgical smoke and aerosol from the operative site, filter out essentially all of the contaminants, and return the filtered air to the operating room.
The smoke evacuator's filter system removes particles from the suctioned airstream at the surgical site. The different types of filters that may be found in hospital-grade smoke evacuators are as follows:
Prefilter. Prefilters made of sponge or wire grating are used to capture objects (e.g., cotton), fluid, or gross particulates that can be accidentally sucked into the airstream and subsequently damage the high-efficiency filter or the evacuator pump.
A HEPA or ULPA filter. A High Efficiency Particulate Air (HEPA) filter captures 99.97% of dioctylphthalate particles 0.3 &mgr;m in diameter. Three particles out of 10,000 may pass through the filter. An Ultra Low Penetration Air (ULPA) filter is designed to capture very small particles and organisms. Research has shown that pathogens such as HIV, HPV, and HBV particles are found attached to droplet nuclei, and that the total size of the particle is significantly larger than the 0.1 &mgr;m particles that an ULPA filter is designed to capture.
Activated charcoal filter. Activated charcoal filters adsorb odors and gaseous hydrocarbons from the waste exhaust. Activated charcoal filters are a carbon-based compound that is baked at high temperatures without the presence of oxygen. This process “activates” the charcoal by removing the organic compounds and leaving only the carbon matrix behind. Through this process, the carbon granules become full of active sites where organic molecules may be captured without changing the carbon structure. The largest user of active sites in activated charcoal is water vapor.
Finally, a final filter is typically employed to remove activated carbon “fines.”
Research confirms the effectiveness of these filter media in screening out harmful contaminants. To extend their use, filters may be impregnated with an antimi

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