Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
1998-10-23
2001-05-08
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S027000, C604S500000
Reexamination Certificate
active
06228048
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to an apparatus for performing colon hydrotherapy, or colonic irrigation, and specifically to a colon hydrotherapy apparatus having precise water temperature control.
BACKGROUND OF THE INVENTION
Colonic irrigation is a process of cleansing the tissues of the lower intestine with water for purposes of removing impacted fecal material and other potentially toxic waste. Colonics are performed both as a preventive measure to sustain healthy digestion, peristalsis, and bowel tissue, and as a treatment for specific diseases such as colitis. Many of the problems addressed by colon hydrotherapy are associated with the typical “western” diet which is low in fiber, centered on meat, dairy, and processed foods, and which is poorly suited for the human digestive tract.
Medical devices have been employed in colonic irrigation for many years. For example, in 1935, U.S. Pat. No. 2,024,967 was issued for an apparatus to rehabilitate peristalsis of the colon. Over the years, colonic lavaging devices have evolved to include certain controls such as water temperature and pressure regulating devices, which ease administration of the colonic while insuring the comfort and safety of the patient. In the typical hydrotherapy procedure, the patient lies on her back or side, and a tube is inserted into the rectum. Fresh water flows into the bowel, loosening waste material from the walls of the colon and allowing the loosened waste material to flow out of the colon.
In the past two decades, colonic machines have reached a relatively high degree of refinement, as has the growing practice of colon hydrotherapy. More recent examples of prior art mechanisms and systems employed in colonic lavage may be seen in U.S. Pat. Nos. 4,190,059, 4,626,239, 4,682,979, and 4,842,580. While most devices are intended for professional use by a licensed colon hydrotherapist, devices have also been designed for home use, such as U.S. Pat. No. 4,645,497. Throughout the continuing evolution in hydrotherapy devices, two variables have remained key in delivering quality colonic treatment: water temperature and water pressure. Precise temperature control is important, not only for safety and comfort of the patient, but also because temperature can affect the peristaltic action of the bowel. Selecting the proper temperature, or alternating the temperature between warm and cool during the colonic, heightens the benefits of the procedure. Precise pressure control is important as excessive water pressure can cause pain and even injury.
Early colonic machines used hot and cold water from a building's plumbing system and simply used gravity to provide safe water pressure. The hot and cold water are passed through a mixing valve to achieve the desired temperature. Water is then delivered into an elevated tank or reservoir. From there, the water flows down naturally into a speculum and to the patient.
By the late 1970s, several problems had become apparent with this type of system. First, the reservoir, which may hold five or more gallons, makes the machine bulky and a more or less permanent installation. Second, precise temperature control is extremely difficult. If the reservoir is inadvertently filled with water that is too hot or too cold, the patient must wait either for the water to adjust on its own, or for the tank to be drained and refilled. Third, once the temperature in the reservoir is established, it cannot be easily varied during the course of the colonic. Fourth, the only way the pressure can be varied is by raising or lowering either the patient or the entire reservoir.
Later colonic machines, starting with U.S. Pat. No. 4,190,059, have addressed these problems by employing regulating valves to control water pressure. In such machines, hot and cold water still come from a building's plumbing system and are mixed through a thermostatically controlled mixing valve to achieve the desired temperature. However, one or more pressure regulating valves then keep the water pressure controlled within a certain range. While this method represents a major improvement over the earlier reservoir method, it too has several shortcomings. First, while temperature is certainly more controllable, water temperature through the mixing valve may still vary by a factor of several degrees. Second, the temperature of the water delivered during the procedure is vulnerable to pressure variances within the building's hot and cold water supply lines. Third, after nearly two decades of using such devices, a number of colon hydrotherapists and patients have come to perceive the earlier, gravity-pressure system as an inherently safer method. Their preference for this more natural type of pressure control is evidenced in part by continued sales and usage of the older reservoir systems, despite their numerous limitations. The present invention, therefore, is directed at alleviating all of these problems and limitations that are associated with both types of colonic irrigation machines of the prior art.
SUMMARY OF THE INVENTION
Objectives of the present invention include providing a colonic irrigation apparatus and method that provides for precise control of the temperature of the water to be delivered to the patient; that offers the benefits and safety of gravity pressurization without the disadvantages associated with machines that rely on bulky reservoirs or tanks; that is easy to set up, use, and adjust; that is highly compact and portable; that is versatile in that it may be used by professional colon hydrotherapists or by home users; and/or that can be used as a subcomponent of, or an attachment to, an existing colonic machine or as a complete system requiring only a colonic table or board. Related objectives include providing a hydrotherapy apparatus and method that provides a method of converting pressurized water from a building's plumbing system into a gravity pressurized flow, easily and conveniently, and provides a new method of controlling a temperature of water mixed from separate hot and cold water inflows, which is extremely precise, within 1° F., even at flow rates as low as 0.1 gallons per minute.
Further objects and advantages of the present invention will become apparent from a consideration of the drawings and ensuing description.
An apparatus for colonic irrigation is disclosed which features a new method of precisely regulating water temperature that far surpasses the technology used in any of the prior art and allows for gravity-pressurization, without the aforementioned limitations and bulk of a reservoir system. In one embodiment, the hydrotherapy apparatus includes:
determining means for determining a predetermined temperature for the lavaging liquid (e.g., a central processor, a user actuated control, etc.);
a temperature sensor (e.g., a thermister, a thermocouple, an RTD,etc.;
comparing means for comparing a first temperature of a first portion of a liquid with the predetermined temperature (e.g., a central processor, a comparator circuit, etc.), the comparing means being in communication with the determining means and the temperature sensor;
control means for generating a control signal (e.g., a central processor, a suitable electrical circuit, etc.) to contact second and/or third portions of the liquid with the first portion;
mixing means for mixing the first portion of the liquid with at least one of the second and third portions of the liquid to form an orifice irrigation liquid (e.g., a water filter, a baffled in line mixer, an impeller, etc.); and
introducing means for introducing the orifice irrigation liquid into the bodily orifice (e.g., a speculum). When the first temperature is less than the predetermined temperature (e.g., the first portion is cold water), a second portion of the liquid having a second temperature more than the predetermined temperature (e.g., the second portion is hot water) is contacted with the temperature sensor. When the first temperature is more than the predetermined temperature (e.g., the first portion is cold wate
CM Robbins Company Inc.
Mendez Manuel
Sheridan & Ross P.C.
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