Surgical systems and methods for biofilm removal, including a sheath for use therewith

Abstract

Systems, methods, and apparatuses for one or more of reducing, removing, or preventing growth of bacterial biofilms are provided, including an endoscopic procedure using a surgical instrument adapted to dispense a pressurized flow of irrigant through a nozzle to substantially remove a layer of bacterial biofilm.

1 . A system for removal of bacterial biofilm from a target site of a human patient, the system comprising:
 an irrigation duct in communication with a fluid source;   a nozzle communicating with the irrigation duct, the nozzle positioned to dispense the fluid directly at a target site;   an aspiration duct in communication with a vacuum source, the aspiration duct terminating at a distal inlet for aspirating fluid dispensed from the nozzle;   an endoscope having an elongated insertion tube defining a working end adapted to facilitate imaging the target site; and   a removable endoscope sheath for providing a barrier over at least a portion of the insertion tube during imaging;   wherein at least one of the irrigation duct and the aspiration duct is associated with the endoscope sheath.   
     
     
         2 . The system of  claim 1 , wherein the endoscope insertion tube defines a substantially rigid proximal portion and a selectively bendable distal portion, and further wherein the endoscope includes a control assembly for actuating bending of the distal portion to aim the working end in a desired direction. 
     
     
         3 . The system of  claim 2 , wherein the nozzle is secured relative to the working end of the insertion tube such that the nozzle can be selectively aimed with selective bending of the insertion tube. 
     
     
         4 . The system of  claim 2 , wherein the distal end of the aspiration duct is secured relative to the working end of the insertion tube such that the aspiration duct can be selectively aimed with selective bending of the insertion tube. 
     
     
         5 . The system of  claim 1 , wherein the aspiration duct further includes a reinforcement member proximate the inlet to reinforce the distal end of the aspiration duct against collapsing. 
     
     
         6 . The system of  claim 1 , wherein the aspiration duct is substantially flexible and further wherein the reinforcement member is a bendable spring. 
     
     
         7 . The system of  claim 1 , wherein the irrigation duct is in communication with the pressurized fluid via a tubing set for conveying a flow of the pressurized fluid from a fluid source to the irrigation duct, the tubing set having an auxiliary inlet for introducing a medicament into the flow of pressurized fluid from the fluid source to the irrigation duct. 
     
     
         8 . The system of  claim 1 , wherein the aspiration duct is formed by:
 an outer tube defining a distal end and a bend proximal the distal end; and   a flexible inner tube slidably received within the outer tube, such that the inner tube extends curvilinearly from the distal end of the outer tube upon extension of the inner tube from the distal end of the outer tube.   
     
     
         9 . The system of  claim 1 , wherein the aspiration duct is formed by:
 an outer tube defining a distal end and a proximal end, the outer tube comprising a body defining an inner lumen and a retainer proximate the distal end; and   an inner tube defining a first portion and a second portion with a naturally-curved and flexible section between the first portion and the second portion,   wherein the inner tube naturally defines a deployed state characterized by a first distance between the first portion and the second portion and is elastically deflectable to a collapsed state characterized by a second, smaller relative distance between the first portion and the second portion;   wherein the first portion of the inner tube is slidably received in the inner lumen of the outer tube and the second portion is received in the retainer of the outer tube to maintain the inner tube in the collapsed state.   
     
     
         10 . An endoscope sheath for use in removing bacterial biofilm from a target site of a human patient, the sheath comprising:
 an elongated, flexible outer sleeve adapted to receive an insertion tube of an endoscope, the outer sleeve defining a distal end maintaining a viewing window; and   an irrigation duct formed as an elongated tube having a distal end maintaining a nozzle, the nozzle being secured adjacent the viewing window and oriented to direct a pressurized stream of fluid away from the viewing window and directly against a layer of bacterial bio film to mechanically remove the bacterial biofilm without substantially damaging an underlying structure of the target site.   
     
     
         11 . A method of removing bacterial biofilm from a target site of a human patient, comprising:
 providing a system for removal of bacterial biofilm from a target site, the system including an endoscope having an insertion tube defining a working end, an irrigation duct connected to a nozzle, an aspiration duct having an inlet, and a removable endoscope sheath for covering the insertion tube, wherein at least one of the irrigation duct and the aspiration duct is part of the removable endoscope sheath;   disposing the working end of the endoscope, the inlet of the aspiration duct, and the nozzle, respectively, proximate the target site, the target site including a layer of bacterial biofilm;   imaging the target site with the working end of the endoscope;   dispensing a flow of fluid through the nozzle, via the irrigation duct, toward the target site to mechanically remove a substantial portion of the layer of bacterial biofilm; and   collecting the removed bacterial biofilm and the dispensed fluid with the inlet end of the aspiration duct.   
     
     
         12 . The method of  claim 11 , wherein the bacterial biofilm is characterized by an adhesion force, and further wherein the fluid is adapted to chemically reduce the adhesion force. 
     
     
         13 . The method of  claim 11 , wherein substantially all the layer of bacterial biofilm is removed with the dispensed fluid. 
     
     
         14 . The method of  claim 11 , further comprising applying a medicament to the target site through the irrigation duct, the medicament adapted to interfere with bacterial biofilm re-growth. 
     
     
         15 . The method of  claim 11 , further comprising delivering a medicament to the target site through the irrigation duct, the medicament selected from the group consisting of a surfactant, a gel, an antimicrobial, a steroid, a growth hormone, and combinations thereof. 
     
     
         16 . The method of  claim 11 , wherein the flow of fluid is directed through the nozzle at a flow rate from about 2 ml/s to about 12 ml/s. 
     
     
         17 . The method of  claim 11 , wherein the target site is within a sinus cavity. 
     
     
         18 . The method of  claim 11 , wherein the target site includes ciliated epithelium. 
     
     
         19 . The method of  claim 11 , wherein the inlet end of the aspiration duct is non-concurrently disposed proximate the structure relative to disposing the nozzle of the irrigation duct proximate the structure. 
     
     
         20 . The method of  claim 11 , wherein the method is performed in treating chronic rhino sinusitis.