Control of halitosis-generating and other microorganisms in the non-dental upper respiratory tract

• US 20060047329A1
• Filed: 02/25/2005
• Published: 03/02/2006
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: Valent Medical Incorporated
• Original Assignee: Valam, Inc.
• Inventors: Krespi, Yosef, Kacker, Ashutosh
• Granted Patent: US 7,544,204 B2
• Time in Patent Office: Days
• US Class Current: 607/86
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2005/0606 Mouth
• CPC Class Codes: A61N 2005/0607 Nose
• CPC Class Codes: A61N 2005/0644 Handheld applicators
• CPC Class Codes: A61N 2005/0651 Diodes
• CPC Class Codes: A61N 2005/0654 Lamps
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/0603 for treatment of body cavities
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

Disclosed are safe, simple and effective broad-spectrum treatments for halitosis and other microbial infections of the nondental upper respiratory tract useful to treat bacterial and other microorganism species, including anaerobic bacteria. Electromagnetic radiative energy including visible, and optionally, thermal, RF and/or microwave wavelengths, is topically applied to internal surfaces of the upper respiratory tract to destroy or incapacitate superficial microorganisms without the use of antibiotics. One useful apparatus is a handheld energy applicator having a light output head suitable for treating the back of the tongue and the tonsils and which may be interchangeably provided with extensions to reach the sinuses. The energy applicator can be supported and guided by a mounting device held between the subject'"'"'s teeth, if desired. Useful embodiments of the invention include preparative treatment of the target surfaces with a photosensitizing agent such as an oxidizing agent or a complementary stain. Optionally a pre-treament procedure may be employed to remove detritus and microfloral overgrowths that may mask more deeply resident target microorganisms. Novel treatments include treatment of halitosis by destruction of bacterial species associated with halitosis, such as Atopobium parvulum, by application of non-ionizing radiative energy to the tonsils and the back of the tongue. Another embodiment comprises a candy bar incorporating a halitosis treatment lamp disposed within the candy.

Claims

1. A method of controlling microorganisms infecting the nondental upper respiratory tract comprising applying electromagnetic energy to infected mucous tissues at a target site in the nondental upper respiratory tract in a manner effective to obtain a desired control of the microorganisms wherein the electromagnetic energy is pulsed and comprises light and optionally heat.

2. A method according to claim 1 wherein the electromagnetic energy comprises pulses of photothermal energy rich in blue light wherein at least 70 percent of the pulse energy in the visible spectrum is polychromatic and is contained in a blue-green waveband of from about 400 to about 600 nm.

3. A method according to claim 1 wherein the electromagnetic energy comprises pulses of photothermal energy rich in blue light wherein at least 70 percent of the pulse energy in the visible spectrum is polychromatic and is contained in a blue waveband of from about 400 to about 500 nm.

4. A method according to claim 1 wherein the electromagnetic energy comprises pulses of photothermal energy wherein the light energy in the visible spectrum is orange or red.

5. A method according to claim 1 wherein the electromagnetic energy has a pulse width of not more than about 200 msec and an interval between pulses of from about 10 to about 2000 msec.

6. A method according to claim 1 wherein the energy application is performed from one to five times per week for a period of from about two to about sixteen weeks.

7. A method according to claim 1 wherein the energy application comprises sufficient photothermal energy to effect a microorganism count reduction of at least about 80 percent.

8. A method according to claim 1 wherein the energy application is effected to raise the temperature of the target tissue to from about 50°

C. to about 70°

C.

30. A method according to claim 1 comprising applying a photosensitizing agent to the target site to sensitize the microorganisms to light prior to applying the electromagnetic energy wherein the photosensitizer is selected from the group consisting of arianor steel blue, toluidine blue, tryptan blue, crystal violet, azure blue cert, azure B chloride, azure 2, azure A chloride, azure B tetrafluoroborate, thionin, azure A eosinate, azure B eosinate, azure mix sicc., azure II eosinate, haematoporphyrin HCl, haematoporphyrin ester, aluminum disulfonated phthalocyanine, chlorines and mixtures of the foregoing photosensitizing agents.

31. A method according to claim 1 comprising a pretreatment effected prior to the application of electromagnetic radiation wherein superficial microorganisms are removed from the target areas and optionally also from the vicinity of the target areas to facilitate access of the electromagnetic radiation to organisms resident beneath the target surfaces.

32. A method according to claim 31 wherein the pretreatment is selected from the group of pretreatments comprising:

superficial cleansing to remove microorganisms;

superficial cleansing to remove microorganisms with desquamation;

application of an effective quantity of broad spectrum antibiotic;

application of an effective quantity of a chemical antibiotic;

application of an effective quantity of chlorhexidine;

mechanical treatment of the surfaces to remove superficial materials optionally using a surgical scraper;

use of an ablation device to mechanically remove superficial organisms, and optionally a layer or layers of epithelial tissue cells;

use of a manual scraper;

use of a brush;

use of a a powered vibrating or oscillating scraper, brush or other suitable abrading device;

use of an ultrasonic vibrating or oscillating scraper, brush or abrasion device and use of controlled laser ablation.

33. A method according to claim 1 of treating microorganisms infecting the nondental upper respiratory tract comprising:

a) applying micromolar concentrations of a photosensitizer to a mucous membrane in the nondental upper respiratory tract to sensitize microorganisms harbored by the mucous membrane to photic energy; and

b) applying nonionizing photic radiation including at least one intensity peak in the orange-red wavelength range of from about 500 to about 700 nm to the mucous membrane and the sensitized microorganisms populating the mucous membrane.

34. A method according to claim 33 comprising employing the photosensitizer and the photic radiation at combined dosages effective to combat target microorganisms and such as to avoid damaging healthy tissue or causing pain or discomfort.

35. A method according to claim 33 comprising employing a molar concentration of from about 1 to about 50 μ

M of photosensitizer.

36. A method according to claim 33 wherein the photosensitizer has a dark-to-light ratio, being the ratio of the minimum concentration required to provide a dosage lethal to a given organism in darkness to the lethal concentration when illuminated of at least 2, at least 3, at least 4 or more than 4.

37. A method according to claim 33 comprising employing as photic energy source photic energy transmitted through a light guide from a continuously operative high energy halogen lamp provided with a broadband filter passing a desired intensity peak of nonionizing photic radiation, the lamp having an output power density measured at 3 cm distance from the end of the light guide with filter of from about 10 to about 20 milliwatts/cm2, optionally from about 10 to about 20 milliwatts/cm2.

38. A method according to claim 1 wherein the longer wavelength energy comprises radiant, convective or conductive heat, RF or microwave energy or combinations of two or more of same.

39. A method according to claim 38 wherein the heat energy is provided by an infrared radiative source, a convective source, a conductive source or by in situ induction by RF or microwave energy.

40. A method according to claim 1 comprising applying a combination of two or more of light energy, heat energy, radio frequency (“

RF”

) and microwave energy.

41. A method according to claim 38 wherein the RF energy is in a range of from about 300 kHz to about 100 MHz and optionally the output power is from about 5 to about 200 W, the pulse duration from about 1 to about 500 msec and the pulse rate is from about 0.1 to about 10 pulse per second.

42. A method according to claim 38 wherein the microwave energy has a frequency or frequencies in the range of from about 100 MHz to about 50,000 MHz,

9. A method for the treatment of halitosis comprising applying light energy to a tonsillar or lingual location determined to harbor a colony of microorganisms generating malodorous gas at a wavelength and intensity and for a duration effective to control the colony of microorganisms.

10. A method of treating halitosis produced by Gram-negative bacteria resident in the pharyngo-oral cavity comprising applying a Gram-negative bacterial sensitizing agent to target tissue ambient to the bacteria and applying photothermal energy to raise the temperature of the ambient tissue to a level sufficient to weaken the sensitized bacteria without causing tissue damage.

11. A method of selectively destroying halitosis bacteria located at the back of the tongue without damaging the surrounding tissue, comprising:

employing a light source and a light directing member to direct the light to the back of the tongue wherein said light directing member is constructed to avoid contact with areas responsible for activating a gagging reflex.

12. A method according to claim 11 wherein the destruction process comprises staining the halitosis bacteria with a photodynamic stain, said photodynamic stain being attached to an antibody which is selectively attachable to at least one type of halitosis bacteria and not to the tongue tissue and comprising selecting the wavelength of the light source so that said wavelength matches said photodynamic stain sensitive wavelength.

13. A method of treating halitosis comprising spraying a photodynamically bactericidal compound on to a target tissue surface harboring bacteria causing halitosis and controlling harmful side effects by preventing the photodynamically active bactericidal compound from diffusing into deeper layers of tissue.

14. A method according to claim 13 wherein the method comprises spraying followed by photoactivating followed by rinsing the treated area.

15. A method according to claim 14 wherein the method is repeated for a duration long enough to reduce bacteria load to a desired value.

16. A method according to claim 13 wherein the method is performed without touching the back of the tongue and creating a gagging reflex.

18. Apparatus for selectively destroying halitosis bacteria located at the back of the tongue without damaging the surrounding tissue, the apparatus comprising a light source, and a light directing member to direct the light to the back of the tongue wherein the light directing member can be operated while avoiding contact with anatomy responsible for activating the gagging reflex.

17. Treatment apparatus according to claim 18 useful for the treatment of a person suffering from halitosis comprising:

a) a handle gripped in proximity to the person;

b) a light output head stably supported on the handle and positioned in the person'"'"'s posterior oral cavity or pharynx in a location juxtaposed to a tonsil or the back of the tongue to output light to the tonsil or the back of the tongue; and

c) a light source to provide light for output from the light output head;

wherein the treatment instrument can be actuated to apply light from the light source to the tonsil or the back of the tongue.

19. Apparatus according to claim 18 wherein said apparatus can emit radiation at a wavelength capable of activating a stain which when applied to the back of the tongue is selectively attached to halitosis-causing bacteria and not to the tongue tissue.

20. Apparatus according to claim 19 wherein said stain is a photodynamic stain which becomes toxic when irradiated at specific wavelength.

21-29. -29. (canceled)

44-51. -51. (canceled)