Wound irrigation and debriding system

Abstract

A method and device for use as a non-invasive pre-filled, self contained, single use, disposable, sterile wound irrigation and debriding system, comprising a pre-filled unit of USP saline solution or sterile water, preferably 120-200 cc. The unit is a flexible, free standing, chamber containing the saline solution and affixed to a nozzle, which may be straight or angled, having a delivery tip and optional return air filter. The device of the present invention is provided in two embodiments, the first being one in which the nozzle is screwed onto the chamber, and the second being a single molded unit. In both configurations, the device is pre-filled, fully assembled, sterilized and packaged at point of manufacturing and delivered in a no-assembly required, ready to use state. The material need for the device is flexible, preferably plastic.

1 . A one piece, non-invasive, sterile dispenser for the irrigation/debriding of wounds and incisions in a human or animal body, which is disposable in any container, comprising: 
 a flexible chamber having an internal volume containing a sterile solution of a composition compatible with and the osmotic characteristics of the body's organs, said chamber having two ends, the first end being closed, and having a flat base, and the second end having an outlet orifice; a nozzle having a first end and a second end, both of said ends being open, said first end being affixed to said orifice of said chamber.    a removable protective tip affixed to said second end of said nozzle, thereby maintaining said solution in a sterile state prior to and after use; and    a removable packaging band around said protective tip for transport and storage;    wherein, when said protective tip and said packaging band are removed and pressure is applied to said chamber, said solution is dispensed from said first end through the opening of said second end into the wound being irrigated and debrided.    
   
   
       2 . The dispenser of  claim 1  wherein said nozzle contains a filter at said first end.  
   
   
       3 . The dispenser of  claim 1  wherein said nozzle has a screw-on cap affixing said first end to said orifice of said chamber.  
   
   
       4 . The dispenser of  claim 1  wherein said nozzle is molded to said chamber.  
   
   
       5 . The dispenser of  claim 1  wherein said sterile solution contains 0.9 percent USP sodium chloride.  
   
   
       6 . The dispenser of  claim 1  wherein said sterile solution contains sterile water.  
   
   
       7 . The dispenser of  claim 1  wherein said chamber is tapered.  
   
   
       8 . The dispenser of  claim 1  wherein the first end of said nozzle is affixed to said orifice of said chamber at an angle between zero degrees (0°) and forty five degrees (45°).  
   
   
       9 . The dispenser of  claim 1  wherein said nozzle is curved towards said second end such that said second end of said nozzle is at an angle from 10 degrees (10°) to thirty degrees (30°) relative to said second end of said chamber.  
   
   
       10 . A method for the irrigation and debriding of wounds in the human or animal body, utilizing a non-invasive, one-piece sterile unit consisting of a flexible tapered chamber having an internal volume containing a sterile solution of a composition compatible with the osmotic characteristics of the body's organs, said chamber having two ends, one end being closed and having a flat base, and the other end having an outlet orifice at one end thereof and being tapered towards said outlet orifice; a nozzle having a first end and a second end, both of said ends being open, said first end having an optional filter, and being affixed to said orifice of said chamber by a screw-on cap or by being molded thereto. said nozzle being affixed to said orifice of said chamber at an angle between zero degrees (0°) and forty-five degrees (45°) and being curved toward the tip of said second end such that said second end is at an angle of from 10 degrees to 30 degrees relative to said first end; a removable protective tip cover affixed to said second end of said nozzle, thereby maintaining said solution in a sterile state prior to and after use; and a removable packaging band around said protective tip cover for transport and storage; said method comprising the following steps: 
 First, retrieve a packaged sterile pad and said one-piece sterile unit;    Second, remove said sterile pad from its packaging, open it, and place said pad in the working area;    Third, remove the packaging and protective tip cover from said one-piece sterile unit and place said unit in an upright position;    Fourth, hold said one-piece sterile unit, point said tip of said unit at the area of the wound to be irrigated, and squeeze said flexible chamber of said unit thereby dispensing said sterile solution through the second end of said unit into the wound;    Fifth, repeat step four as often as needed;    Sixth, after finally completing the irrigation/debriding process, discard said sterile pad and said one-piece sterile unit into any wastebasket, after use.