CONTROL OF MICROORGANISMS IN THE SINO-NASAL TRACT

• US 20090018485A1
• Filed: 09/16/2008
• Published: 01/15/2009
• Est. Priority Date: 10/15/2003
• Status: Abandoned Application

• Current Assignee: Valam Corp
• Original Assignee: Valam Corp
• Inventors: KACKER, Ashutosh, KRESPI, Yosef
• Application Number:
  US12/211,295
• Publication Number:
  US 20090018485A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• 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 2005/0654 Lamps
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/0624 for eliminating microbes, germs, bacteria on or in the body

Abstract

Disclosed are methods and apparatus for safe, simple and effective broad-spectrum treatments of chronic rhinosinusitis and other common and less common infections of the sino-nasal tract which may implicate not only a wide range of bacterial species but also fungi and viruses. Electromagnetic radiative energy including visible, and optionally, thermal RF, microwave or other longer wavelengths, is applied to target internal surfaces of the sino-nasal tract to destroy or incapacitate superficial microorganisms without the use of antibiotics. The treatment can be controlled to permit regrowth of healthy microflora. A handheld energy applicator has a light output head receivable into, or engageable with, the treatment subject'"'"'s nostril which may be provided with extensions to reach the sinuses. Useful embodiments of the invention include pretreatment of target sino-nasal surfaces with a photosensitizing agent such as an oxidizing agent or a complementary stain. For example methylene blue can be used with orange or red light. The combination treatment of photosensitizer and application of visual wavelength energy provides a flexible treatment regimen which enables low concentrations of stains to be employed, minimizing aesthetic problems.

Claims

1-9. -9. (canceled)

12-25. -25. (canceled)

28-41. -41. (canceled)

42. A method of controlling microorganisms in the sino-nasal tract of a subject, the method comprising:

applying visible spectrum light, optionally diffused, to a microorganism-infected target site in the sino-nasal tract in a dosage effective to control the microorganisms without physiological damage;

applying a photosensitizing stain to the target site to sensitize the microorganisms to the laser light prior to applying the laser light wherein the laser light dosage comprises an energy density at the target site of from about 0.5 to about 3 Joule/cm² and a duration of from about 20 seconds to about 2 minutes; and

repeating the application of laser light with a frequency of from about one to about twenty times per month, optionally from about two to about ten times per month, for a period of from about two weeks to about six months.

10. A method according to claim 42 conducted by employing a handheld applicator instrument to apply the light wherein the handheld applicator instrument comprises a handholdable body accommodating a light source a light output head comprising the light energy output port and a light transmitting neck supporting the light output head on the handholdable body.

11. A method according to claim 10 wherein the handheld applicator instrument comprises a sinus extension for sinus treatment the sinus extension comprising an extended light transmitting neck supporting the light output port to be passed through a nostril of the treatment subject and to be positioned to address a selected sinus area, the method comprising applying the treatment energy when the light output port is addressing the selected sinus area, the handheld applicator instrument optionally comprising a handholdable body accommodating a light source and a light output head comprising the light energy output port wherein the light transmitting neck supports the light output head on the handholdable body.

43. A method of treating a persistent chronic rhinitis or sinusitis or rhinosinusitis condition comprising infection of the sino-nasal tract by at least one species of microorganism selected from the group consisting of Staphylococcus aureus, alpha-hemolytic streptococci, Streptococcus pneumoniae, Haemophilus influenzae and coagulase-negative Staphylococci by controlling the microorganisms in the sino-nasal tract of the subject, the method comprising applying visible spectrum light to a microorganism-infected mucosal surfaced target site in the sino-nasal tract in a dosage effective to control the microorganisms without physiological damage to the subject, optionally by reducing the microorganism population by about 50-90%, wherein the method is performed to leave a residual population of at least 10 percent of the pretreatment microorganism population.

44. A treatment system for use in controlling microorganisms infecting the sino-nasal tract of a subject, wherein the treatment system comprises:

a handheld light applicator instrument, the applicator instrument comprising;

(a) a handholdable body;

(b) a light output head having a light output port insertable into a nostril of the subject to output light into the sino-nasal tract of the subject;

(c) a user-controllable light source to deliver visible laser or LED light to the light output port; and

(d) a diffuser to spread the laser light for application to the target site.

26. A treatment system according to claim 44 wherein the applicator instrument comprises a light transmitting neck supporting the light output head on the handholdable body.

27. A treatment system according to claim 44 wherein the applicator instrument comprises a sinus extension for sinus treatment the sinus extension comprising an extended light transmitting neck supporting the light output port to be passed through a nostril of the treatment subject and to be positioned to address a selected sinus area.