Method and apparatus for the ultrasonic cleaning of biofilm coated surfaces

• US 20060069343A1
• Filed: 10/24/2005
• Published: 03/30/2006
• Est. Priority Date: 10/03/2003
• Status: Active Grant

• Current Assignee: Dr. Michael Rontal
• Original Assignee: Dr. Michael Rontal
• Inventors: Rontal, Michael
• Granted Patent: US 7,522,955 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/00761 Removing layer of skin tissue, e.g. wrinkles, scars or cancerous tissue
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61L 2/0005 for pharmaceuticals, biologicals or living parts

Abstract

To treat body surfaces, such as the sinuses, which are coated with biofilms, the surface is irrigated and suctioned with a fluid which may contain a biocide or other chemical agent for disrupting the biofilm while ultrasonic energy is applied to either the fluid barrier formed over the biofilm or a body surface proximal to the biofilm. Action of the fluid enhanced by the ultrasonic energy tends to remove sections of biofilm which are suctioned out of the site. An electrical field may also be applied to the biofilm to enhance the disruptive action. Apparatus for practicing this method to treat chronic rhinosinusitis comprises an elongated tube adapted to be inserted into sinus cavities through the nose or mouth. The tube includes a first lumen which feeds an irrigating fluid containing biocides and/or biofilm-disruptive chemicals to the treatment site and a second lumen which suctions fluid from the site. An ultrasound horn extends through the tube and its distal end introduces ultrasonic energy into the fluid layer overlying the biofilm. Alternatively, an ultrasound probe may be applied to an adjacent body surface, such as the face over a sinus cavity. In an alternative embodiment, the tube includes a pair of electrodes which establish an electric field across the biofilm, accelerating degradation.

Claims

1. The method of reducing a biofilm formed on a substrate, comprising:

irrigating the biofilm with a fluid containing a biofilm-reducing agent;

suctioning the fluid from the biofilm, so as to maintain a fluid layer of the fluid in contact with the biofilm; and

inducing ultrasonic energy into the biofilm.

2. The method of claim 1 wherein the ultrasonic energy is induced into the biofilm by application of ultrasonic energy into the substrate.

3. The method of claim 1 wherein the substrate is the surface of human tissue.

4. The method of claim 3 where the human tissue comprises a body cavity.

5. The method of claim 4 wherein the body cavity constitutes a sinus cavity within a human head and the biofilm is disposed in a mucus layer on the sinus lining.

6. The method of claim 5 further comprising introducing and removing the fluid through an elongated tube having its distal end disposed within the body cavity and its proximal end exterior of the body.

7. The method of claim 6 further comprising introducing the ultrasonic energy into the fluid layer through said elongated tube.

8. The method of claim 6 further comprising inducing the ultrasonic energy into the biofilm by applying ultrasonic energy onto the exterior of the human head.

9. The method of claim 8 wherein the ultrasonic energy is introduced through a bag of an ultrasonic-transparent fluid maintained in pressured contact with the exterior of the head.

10. The method of claim 1, further comprising:

establishing an electric field across the biofilm directly or through the fluid layer.

11. The method of claim 5 wherein the biofilm-reducing agent is chosen from the group consisting of guaifenesin, dornase alfa or N-acetylcysteine or a derivative thereof to simultaneously attack the biofilm and reduce the mucus layer on the sinus lining.

12. The method of reducing biofilm resident on human tissue comprising:

surrounding a section of the tissue coated with biofilm by a cavity having an open edge with a resilient gasket formed thereon;

introducing fluid containing a biofilm-reducing agent into the cavity;

suctioning excess fluid and biofilm residue from the cavity; and

applying ultrasonic energy into the fluid contained within the cavity to produce mechanical forces on the biofilm.

13. The method of claim 12 further comprising establishing an electric field across the biofilm or the fluid layer in contact with the biofilm to further enhance biofilm-reductive action.

14. The method of claim 13 further comprising mechanically agitating the biofilm surface in contact with the fluid within the cavity by a mechanical instrument introduced into the cavity.

15. Apparatus for treating biofilm covered tissue forming part of a cavity within a living body comprising:

an elongated tube adapted to be inserted into the body so that its distal end is disposed within the cavity and its proximal end is exterior of the body, the tube containing a first lumen for introducing fluid into the cavity and a second lumen for suctioning fluid from the cavity;

a first port for introducing fluid containing biofilm treatment reducing agents into the proximal end of the first lumen;

a second port at the proximal end of the tube for applying a suction force to the second lumen to suction fluid from the cavity; and

an ultrasonic generator operative to introduce ultrasonic energy into the biofilm.

16. The apparatus of claim 15 further including a pair of electrodes extending along the tube between the distal and the proximate end, and an electric generator for applying an electric potential to the proximal ends of the electrodes so as to create a field across the biofilm or the fluid in contact with the biofilm within the cavity.

17. The apparatus of claim 15 wherein the ultrasonic energy is introduced into the biofilm through a third lumen in said tube.

18. The apparatus of claim 17 wherein the tube is manually deformable.

19. The apparatus of claim 15 further including:

a source of mechanical motion connected to the proximal end of the tube;

a biofilm abrading device supported on the distal end of the tube; and

an elongated member extending through the tube connecting said source of mechanical motion to said biofilm abrading device to impart motion to the abrading device relative to the tube.

20. The apparatus of claim 19 in which the mechanical motion is rotational.

21. The apparatus of claim 19 in which the mechanical motion is vibratory.

22. The apparatus of claim 15 in which the ultrasonic generator introduces energy into the proximal end of the first lumen.

23. The apparatus of claim 15 in which the distal end of the elongated tube is manually deformable.

24. The apparatus of claim 15 in which the distal end of the elongated tube is removable from the proximal end for replacement purposes.

25. Apparatus for treating biofilm covered tissue forming part of a cavity within a living body comprising:

an elongated tube adapted to be inserted into the body so that its distal end is disposed within the cavity and its proximal end is exterior of the body, the tube containing a first lumen for introducing fluid into the cavity and a second lumen for suctioning fluid from the cavity;

a first port for introducing fluid containing biofilm treatment reducing agents into the proximal end of the first lumen;

a second port at the proximal end of the tube for applying a suction force to the second lumen to suction fluid from the cavity; and

an ultrasonic generator supported on the distal end of the elongated tube operative to introduce ultrasonic energy into fluid contained within the cavity.

26. The apparatus of claim 25 further including an electric power source for said ultrasonic generator.

27. The apparatus of claim 26 wherein the electric power source is connected to the ultrasonic generator by electrical conductors passing through the elongated tube.

28. The method of reducing a biofilm disposed on human tissue, comprising:

irrigating the biofilm with a fluid;

suctioning the fluid from the biofilm so as to remove material separated from the biofilm; and

inducing ultrasonic energy into the biofilm.

29. The method of claim 28 wherein the human tissue is disposed on the interior of a human body and the ultrasonic energy is induced into the biofilm by applying an ultrasonic probe against the exterior of the body, proximate the biofilm.

30. The method of claim 29 wherein the ultrasonic energy from the probe is introduced into the body through a fluid-filled bag supported in pressured contact with the exterior of the body.

31. The method of claim 30 in which the human tissue constitutes the surface of a patient'"'"'s sinus and the fluid-filled bag is applied to the patient'"'"'s head.