US2009018485A1PendingUtilityA1

Control of microorganisms in the sino-nasal tract

48
Assignee: VALAM CORPPriority: Oct 15, 2003Filed: Sep 16, 2008Published: Jan 15, 2009
Est. expiryOct 15, 2023(expired)· nominal 20-yr term from priority
A61N 2005/0654A61N 5/0624A61N 2005/0607A61N 5/062A61B 18/1815A61N 2005/0606A61N 2005/0644A61N 5/0601A61B 18/18
48
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Claims

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

exact text as granted — not AI-modified
1 - 9 . (canceled) 
     
     
         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. 
     
     
         12 - 25 . (canceled) 
     
     
         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. 
     
     
         28 - 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/cm 2  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.   
     
     
         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.

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