Method and system for detecting leaks and/or verifying adequate closure following a medical procedure

Abstract

System for detecting leaks and/or verifying adequate closure following a medical procedure, on a hollow or tubular organ of a subject, wherein a leak test is performed by injecting or insufflating, in the concerned organ, a specific test gas which is not commonly produced or naturally present within the body of the subject, or which is present or produced in a precisely known amount or concentration, and by analyzing percutaneously the gas or gas mixture present locally within the body cavity in which the organ is situated, and then verifying the presence, and preferably determining the concentration, of the injected or insufflated test gas in the local gas or gas mixture of the body cavity and indicating whether the concerned organ or a lumen defined by the latter is leak-free or not.

1 . A system for detecting a presence or absence of a leak in a hollow organ of a human or animal subject, comprising:
 an injection module; a detection module; and a computational module;   wherein:   a test gas is injected or insufflated in a controlled manner into a hollow organ by means of said injection module, wherein said test gas is not a gas that is naturally present within said body cavity, or wherein said test gas is naturally present within said body cavity in a precisely known amount or concentration;   said detection module and said computational module are configured to cooperate, simultaneously with or immediately after the injection module starts operating, in a synchronized manner to determine whether the test gas is present in a body cavity in which the hollow organ is located, and thereby indicate, after computing, whether the hollow organ is leak-free; and   the injection and detection modules operate in a synchronized manner under the operative management of the computational module, which communicates with said injection and detection modules.   
     
     
         2 . The system according to  claim 1 , wherein said detection module determines a concentration of said test gas in said body cavity. 
     
     
         3 . The system according to  claim 1 , further comprising a user interface that communicates with the computational module, said user interface comprising a control that receives information entered by a user of the system, and a display that displays information to the user. 
     
     
         4 . The system according to  claim 1 , wherein:
 said injection module is configured to control injection of the test gas and measure or standardize at least one of a volume, concentration, detected test gas pressure in the hollow organ, or rate of injection of the test gas delivered from a corresponding source; and   said injection module comprises a pressure gauge.   
     
     
         5 . The system according to  claim 4 , wherein said pressure gauge determines a pressure within at least one of an injection tubing of said injection module or inside said hollow organ. 
     
     
         6 . The system according to  claim 1 , wherein said detection module comprises:
 an access component, configured to provide percutaneous fluidic access inside said body cavity, adjacent said hollow organ; and   a transferring component that transfers at least one sample of a gas or gas mixture inside the body cavity to an external analyzing module that makes a real time presence or concentration measurement of the test gas within the at least one sample.   
     
     
         7 . The system according to  claim 3 , wherein said computational module:
 stores and treats data provided by said injection module, said detection module, and said user interface,   communicates with and operatively manages said injection module and said detection module,   retrieves information from said user interface and from a local or remote data storage, and   sends information to a user interface.   
     
     
         8 . The system according to  claim 1 , wherein said injection module, said detection module, and said computational module are part of a pre-existing medical system. 
     
     
         9 . The system according to  claim 8 , wherein said pre-existing medical system is an anaesthesia apparatus. 
     
     
         10 . The system according to  claim 3 , wherein said injection module, said detection module, said computational module, and said user interface are all integrated in a same independent housing, said housing being configured to cooperate with a medical setting. 
     
     
         11 . The system according to  claim 3 , wherein said injection module, said detection module, said computational module, and said user interface are physically located in at least two separate housings, each of said at least two separate housings or each of said modules being configured for mutual wireless communication or for mutual communication through a physical link. 
     
     
         12 . The system according to  claim 11 , wherein said injection module is incorporated within a separate independent housing from said detection module, said computational module, and said user interface, and comprises a handheld instrument. 
     
     
         13 . The system according to  claim 12 , wherein said handheld instrument is a flexible endoscope. 
     
     
         14 . The system according to  claim 11 , wherein said injection module and said detection module are located in one or more housings separate from a housing incorporating said computational module, each of the housings being configured for wireless communication and comprising said injection and detection modules and said user interface, said user interface comprising a control and a display. 
     
     
         15 . The system according to  claim 3 , wherein the user interface is a smartphone with a corresponding software application that communicates at least with the computational module.