Method and apparatus for the ultrasonic cleaning of biofilm coated surfaces

• US 8,992,460 B2
• Filed: 04/21/2009
• Issued: 03/31/2015
• Est. Priority Date: 10/03/2003
• Status: Active Grant

• Current Assignee: Dr. Michael Rontal
• Original Assignee: Dr. Michael Rontal
• Inventors: Rontal, Michael
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US12/427,257
• Publication Number:
  US 20090247937A1
• Time in Patent Office: 2,170 Days
• Field of Search: 604 19- 22, 604 39- 40, 604/43, 604 46- 48, 604/93.01, 604/95.01, 604/506, 604/516, 604/131, 604/264, 604/523, 604/540, 604/317, 606 27- 28, 601/2
• US Class Current: 604/22
• 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. Medical treatment apparatus, comprising:

an elongated tube having a proximal end and a distal end adapted to be inserted into a cavity within a living body having a biofilm coating so that the distal end of the tube 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 physically separate from the elongated tube, disposed externally of the body and operative to introduce ultrasonic energy through an external wall of the body and into the biofilm at a power level below the level which will destroy the tissue underlying the biofilm.

2. The apparatus of claim 1 wherein the tube is manually deformable.

3. The apparatus of claim 1 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.

4. The apparatus of claim 3 in which the mechanical motion is rotational.

5. The apparatus of claim 3 in which the mechanical motion is vibratory.

6. The apparatus of claim 1 in which the distal end of the elongated tube is manually deformable.

7. The apparatus of claim 1 in which the distal end of the elongated tube is removable from the proximal end for replacement purposes.

8. The medical treatment apparatus of claim 1 wherein the elongated tube is adapted to be inserted into a sinus cavity in a human living body and said external wall of the body is the head of the human.