Apparatus and method for debilitating or killing microorganisms within the body

#This invention relates to an apparatus and method for the destruction of micro-organisms on or within a body cavity of a patient through the use of radiation.

#Infections involving the human gastrointestinal tract are extremely common, involving many millions of people on an annual basis. These infections include bacteria, viruses, and fungi, and are responsible for significant illness, morbidity and, in many cases, death. While the invention has utility in destroying microorganisms in various parts of the body, e.g., the stomach, bowel, lungs, peritoneal cavity, urinary tract, etc., it is particularly useful in the treatment of gastrointestinal infections.

#It has recently been shown that the most common gastrointestinal infection in the world is due to Helicobacter pylori, a bacterial pathogen that infects the stomach and duodenum. In the United States, for example, Helicobacter pylori is found in approximately 20% of the adult population. It is a chronic gut infection and, once acquired, is notoriously difficult to cure. Most infectious bacteria can be readily destroyed by the human immune system; however, Helicobacter pylori lives in the lumen of the stomach and on the surfaces of the stomach and duodenal cells, making it relatively resistant to a host immune response, even if vigorous. Its position has, however, been taken advantage of in the treatment method and apparatus employed in the present invention.

#FIG. 1 is a vertical cross-sectional view showing the use of the invention in the stomach.

#FIG. 2 is a view similar to FIG. 1 showing an elliptical balloon in use for positioning a radiation source in the stomach.

#FIG. 3 is a diagrammatic, longitudinal, cross-sectional view of an instrument and supporting equipment in accordance with one form of the invention.

#The therapeutic method in accordance with the present invention is suited for use in various body cavities including, but not limited to, the stomach, the bowel, the lungs, the peritoneal cavity, the urinary tract, and can also be used with various devices, fabrication methods, arrangements, systems and methods of employment which irradiate the walls of various body cavities or interior sites within the body of a patient by means of radiation in sufficient amount to debilitate or kill microorganisms lining the body cavity in which the invention is used.

#In one preferred form of the invention, an x-ray device is provided which includes components for producing localized x-ray radiation within a vacuum housing or tube and, optionally, including an inflatable balloon surrounding the vacuum housing and preferably connected near the distal end of the device for positioning the source of radiation as well as for expanding the walls of the body cavity. While the invention can be employed for killing or debilitating various pathogenic microorganisms, it can be used to advantage in treating Helicobacter pylori infections of the gastrointestinal system and other ailments in which radiation is to be delivered to portions of the body that are not easily accessible. In order to provide a better understanding, the present invention will be described by way of example in the treatment of Helicobacter pylori infections within the stomach. It should be understood, however, that the invention is not limited to specific apparatus or methods described.

#Helicobacter pylori is an infection of the stomach and duodenum and the major cause of stomach ulcers. Various forms of radiation, including x-rays, radiation from isotopes, radio waves, microwaves, or light radiation, e.g., ultraviolet light in accordance with the invention provide an advantageous method of treating such infections. The x-ray device, for example, produces radiation that penetrates the lining of the body cavity, in this case the columnar epithelial lining of the walls of the stomach, or the epithelium of any other passage or lumen that is being treated. During this treatment, the radiation produces apoptosis or programmed cell death in which the DNA of the microorganism is rendered unable to divide. The apoptosis that occurs in the microorganisms is different from necrosis, another type of cell death. In apoptosis produced by the radiation, a disruption of the gene structure of the microorganism prevents it from further replication. Consequently, the microorganisms die by mutation and, in some cases, by the disruption of metabolic processes at the cellular level. Some fraction of the microorganisms may also be killed immediately by the radiation. An important advantage of the invention lies in the fact that many organisms, such as bacteria, are exquisitely sensitive to radiation, sensitive to a much greater degree than the surrounding human cells. Accordingly, the bacteria can be killed or debilitated by apoptosis without serious destruction of the host cells.