THERAPEUTIC METHOD AND APPARATUS FOR DEBILITATING OR KILLING MICROORGANISMS WITHIN THE BODY

• US 20010049464A1
• Filed: 06/23/1999
• Published: 12/06/2001
• Est. Priority Date: 06/23/1999
• Status: Active Grant

• Current Assignee: Sterilight, Inc.
• Original Assignee: Robert A. Ganz
• Inventors: GANZ, ROBERT A.
• Granted Patent: US 6,464,625 B2
• Time in Patent Office: Days
• US Class Current: 600/1
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61N 2005/0609 Stomach and/or esophagus
• CPC Class Codes: A61N 2005/0651 Diodes
• CPC Class Codes: A61N 2005/0654 Lamps
• CPC Class Codes: A61N 2005/0661 ultraviolet
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy
• CPC Class Codes: H01J 2235/164 Small cross-section, e.g. for entering in a body cavity
• CPC Class Codes: H01J 35/32 Tubes wherein the X-rays are produced at or near the end of the tube or a part thereof which tube or part has a small cross-section to facilitate introduction into a small hole or cavity

Abstract

A treatment method and apparatus for debilitating or killing Helicobacter pylori or other microorganisms within the body of a patient is especially suited for treating stomach or duodenal ulcers. The present therapeutic method involves the use of ionizing radiation for eliminating pathogenic microorganisms within or supported upon the lining of a body cavity of a patient, e.g., the stomach. An elongated flexible shaft is provided for insertion into the body in any of various ways selected by the surgeon. It can be placed endoscopically, e.g., through the esophagus, placed surgically, placed laparoscopically or by CAT scan-guided percutaneous insertion. A radiant energy distribution head is provided at the end of the flexible shaft to transmit ionizing radiation for destroying microorganisms within the body. Radiant energy, e.g., x-ray, ultraviolet light, beta radiation, gamma radiation, radio waves, microwaves, or infrared energy, is then transferred from the head of the instrument to the epithelium around the head of the instrument in an amount sufficient to debilitate or kill the Helicobacter pylori or other microorganisms in the lining of the body cavity.

Claims

1. A therapeutic method for killing or debilitating Helicobacter pylori or other microorganisms within the body of a patient, said method comprising:

providing an ionizing radiation source for inactivating the microorganism,

providing an elongated shaft for insertion into a body cavity of the patient,

providing an ionizing radiation distribution head at a distal end of the shaft for supplying the ionizing radiation from the source to the body,

inserting the distribution head into a body cavity of the patient,

causing the ionizing radiation to be transferred from the head to the body cavity surrounding the head of the instrument in an amount sufficient to debilitate or kill Helicobacter pylori or other microorganisms supported by the epithelium lining the body cavity being treated.

2. The method of

claim 1

including irradiating the body cavity with ionizing radiation selected from the group consisting of x-ray radiation, beta radiation, gamma radiation, ultraviolet radiation, infrared radiation, radio waves, and microwaves.

3. The method of

claim 1

wherein the radiation source is a radioactive isotope.

4. The method of

claim 3

wherein the radioactive isotope emits ionizing radiation selected from the group consisting of beta radiation and gamma radiation.

5. The method of

claim 1

including providing x-ray radiation from a vacuum tube located within the distribution head at the distal end of the shaft.

6. The method of

claim 1

wherein the distribution head is positioned as required to accomplish treatment of the stomach for debilitating or killing Helicobacter pylori, and the distribution head is repositioned as required to treat different areas of the stomach until all of the infected areas in which treatment is desired are exposed to the ionizing radiation.

7. The method of

claim 1

including the steps of securing a positioning balloon to a distal portion of the shaft to enclose the head, and introducing an inflation fluid into the balloon to expand the balloon for stretching the body cavity being treated so as to distend the wall of the body cavity and thereby smooth out the epithelium lining the body cavity and enhance uniform treatment of the cavity wall.

8. The method of

claim 7

wherein the body cavity comprises the stomach and including inflating the balloon to a sufficient size so as to contact a wall of the stomach on each side of the balloon for locating the head of the instrument substantially equidistant from all of the wall portions of the stomach that are in contact with the positioning balloon.

9. A therapeutic method for denaturing or killing Helicobacter pylori within the body of a patient, said method comprising:

providing an ionizing radiation source for inactivating the H. pylori,

providing an elongated flexible shaft for transesophageal insertion into the stomach of the patient,

providing an ionizing radiation distribution head at a distal end of the flexible shaft for supplying the ionizing radiation from the source to the stomach,

inserting the distribution head into the stomach,

causing the ionizing radiation to be transferred from the head to the epithelium of the stomach surrounding the head of the instrument in an amount sufficient to debilitate or kill Helicobacter pylori carried on the epithelium of the stomach.

10. The method of

claim 9

wherein the ionizing radiation is selected from the group consisting of x-ray radiation, beta radiation, gamma radiation, ultraviolet radiation, infrared radiation, radio waves, and microwaves.

11. The method of

claim 9

including the step of producing x-ray radiation between an anode and a cathode located within the distribution head.

12. The method of

claim 9

wherein the distribution head is placed within a means for positioning the head equidistant from surrounding tissue.

13. The method of

claim 12

wherein the means for positioning comprises an inflatable balloon having a free distal end spaced apart from the distribution head, and including inflating the balloon after inserting the distribution head into a body cavity of the patient to spread and flatten the walls of the body cavity and to maintain the distribution head a selected distance from the walls of the body cavity for enhancing uniform distribution of the radiation to the surrounding cavity walls.

14. An apparatus for killing or debilitating Helicobacter pylori or other microorganisms within a body cavity of a patient, said apparatus comprising:

an elongated shaft for insertion into a body cavity of a patient,

an ionizing radiation source connected to the shaft for destroying the microorganisms,

an ionizing radiation distribution head at a distal end of the shaft for supplying ionizing radiation from the source to the body,

whereby the ionizing radiation transferred from the distribution head to the body cavity surrounding the head of the apparatus is adapted to kill or debilitate Helicobacter pylori or other microorganisms supported on or within the epithelium lining the body cavity that is being treated.

15. The apparatus of

claim 14

wherein the ionizing radiation is selected from the group consisting of x-ray radiation, beta radiation, gamma radiation, ultraviolet radiation, infrared radiation, radio waves, and microwaves.

16. The apparatus of

claim 14

wherein the radiation source comprises an anode and a cathode positioned within a vacuum tube contained in the distribution head.

17. The apparatus of

claim 14

wherein the radiation is ultraviolet radiation and the shaft includes an optically transparent element for transferring ultraviolet light from a source of ultraviolet radiation through the shaft to the distribution head whereby the radiation is projected onto the wall of the body cavity that is being treated.

18. The apparatus of

claim 14

wherein the radiation source comprises a radioactive isotope contained in the distribution head.

19. The apparatus of

claim 14

wherein the shaft includes a means for conveying microwave or radio wave energy through the shaft to the distribution head for transferring the radiant energy to the lining of the body cavity surrounding the distribution head in a sufficient amount to kill or debilitate microorganisms supported on or within the lining of the body cavity.

20. The apparatus of

claim 14

wherein an expandable balloon is connected to the shaft to surround the distribution head and the balloon has a free unsupported end spaced apart distally from the distribution head.

21. The apparatus of

claim 20

wherein radially extending positioning members are connected between the distribution head and the balloon for holding the balloon in a predetermined position surrounding the distribution head.

22. The apparatus of

claim 17

wherein the radiation source is a mercury vapor or arc lamp.

23. The apparatus of

claim 14

wherein the radiation source comprises an infrared laser.