# US 2014/0196721 A1 · Pressure release means and placement indicator for inflatable catheter or respiratory gas supply retention means > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0196721 A1 - Document ID: US20140196721A1 - Status: Published application - Kind: A1 - Application number: 13/740,183 - Filed: 2013-01-12 - Published: 2014-07-17 - Earliest claimed: 2013-01-12 - Inventors: Terence Gilhuly - Web page: https://patentgrep.com/patent/US20140196721A1 ## CPC - A61M 16/044: {External cuff pressure control or supply, e.g. synchronisation with respiration} - A61M 16/209: {Relief valves} - A61M 16/0409: {with mean for closing the oesophagus} - A61M 16/0434: {Cuffs} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Under- and overinflation of retention balloons and cuffs for catheters including Foley catheters, and for endotracheal tubes, tracheostomy tubes, laryngeal mask airways and similar devices is correlated with hospital acquired infections and with patient injury. In this patent, a solution that correctly inflates inflatable retention devices is taught, whereby a pressure release means is incorporated into the inflation pathway from the fluid input syringe to the retention means while inflating. This pressure release means can be set to open at or near the optimal fluid pressure so that overinflation can be prevented by releasing any pressure above the optimal pressure and underinflation can be prevented by a user pressurizing the cuff until the valve is noticed to open. As well, observation of fluid leaked through the pressure relief means can indicate misplacement of the retention means, allowing the user to reposition it before patient injury occurs. The invention is presented as a standalone part and in a format whereby the invention is integrated into existing airway cuff inflation designs. ## Claims ### Claim 1 An adaptor to connect the inflatable retention means of a catheter or a respiratory gas supply means to an inflation mechanism, where said catheter or respiratory gas supply retention means comprises a retention means to secure the catheter including an inflatable cuff or balloon, an inflation line to said retention means and an inflation port with a one-way valve through which an inflation fluid is injected to enter said inflation line and to fill said inflation line and said retention means, where said adaptor comprises a main body with proximal and distal ends and containing a cavity connecting the proximal and distal ends, and a pressure release means set to open when the internal pressure of said main body cavity reaches a defined pressure, where said proximal end has a connection means to receive an inflation means such as a syringe; and said distal end has a connection means to connect with said inflation port of said catheter or respiratory gas supply retention means. ### Claim 2 (depends on 1) The adaptor of claim 1 where said catheter or respiratory gas supply means includes one of a Foley catheter, an endotracheal tube, a tracheostomy tube or a laryngeal mask airway. ### Claim 3 (depends on 1) The adaptor of claim 1 where the pressure release means is one of an umbrella valve, a rubber flap, a spring-loaded trap and a duckbill valve. ### Claim 4 (depends on 1) The adaptor of claim 1 where the pressure release means opens at or above a pressure of 20 cmH2O. ### Claim 5 A method of inflating a catheter or respiratory gas supply retention means to prevent over-inflation and under-inflation where said catheter or respiratory gas supply retention means comprises an inflatable retention means to secure the catheter including a cuff or balloon, an inflation line to said retention means and an injection port with a one-way valve through which an inflation fluid is injected to enter said inflation line and to fill said line and said retention means, including the steps: a) the catheter or respiratory gas supply means is inserted into a patient; b) a syringe containing a fluid including air, water or saline is connected to an adaptor, said adaptor comprising a main body with proximal and distal ends and containing a cavity connecting the proximal and distal ends, and a pressure release means set to open when the internal pressure of said main body cavity reaches a defined pressure, where i. said proximal end has a connection means to receive an inflation means such as a syringe; and ii. said distal end has a connection means to connect with said inflation port of said catheter or respiratory gas supply retention means c) said adaptor is connected to said inflation port of catheter or respiratory gas supply retention means d) said syringe is compressed to inject said fluid into said adaptor and into said inflation cuff; and e) said compression of said syringe continues until said pressure release means is activated causing said pressure release means to open with or without fluid escaping through said pressure release means or said cuff is judged to be properly inflated. ### Claim 6 (depends on 5) The method of claim 5 where said catheter or respiratory gas supply means includes one of a Foley catheter, an endotracheal tube, a tracheostomy tube or a laryngeal mask airway. ### Claim 7 (depends on 5) The method of claim 5 where said pressure release means is one of an umbrella valve, a rubber flap, a spring-loaded trap and a duckbill valve. ### Claim 8 (depends on 5) The method of claim 5 where the pressure release means opens at or above 20 cmH2O. ### Claim 9 A catheter or respiratory gas supply retention means comprising: i. an inflatable retention means to secure the catheter including an inflatable cuff or balloon; ii. an inflation line to said inflatable retention means; iii. an injection port with a proximal end having an interface to accept input of a fluid, a one-way non-return valve, and a distal end in fluid connection with said inflation line, to allow input of fluid to inflate said retention means including inflatable cuff or balloon; and iv. a pressure release means to prevent inflation of said inflatable retention means beyond a defined pressure. ### Claim 10 (depends on 9) The catheter or respiratory gas supply means of claim 9 where said injection port further comprises said pressure release means. ### Claim 11 (depends on 10) The catheter or respiratory gas supply means of claim 10 where said pressure release means is located outside of the fluid cavity defined by said cuff, inflation line and non-return valve. ### Claim 12 (depends on 9) The catheter or respiratory gas supply means of claim 9 where the pressure release means is one of an umbrella valve, a rubber flap, a spring-loaded trap and a duckbill valve. ### Claim 13 (depends on 9) The catheter or respiratory gas supply means of claim 9 where the pressure release means opens at or above a pressure of 20 cmH2O. ### Claim 14 (depends on 9) The catheter or respiratory gas supply means of claim 9 where said catheter or respiratory gas supply means includes one of a Foley catheter, an endotracheal tube, a tracheostomy tube or a laryngeal mask airway. ### Claim 15 A method of preventing overinflation of an inflatable catheter or respiratory gas supply retention means when applying a catheter or respiratory gas supply to a patient, a catheter or respiratory gas supply retention means including said inflatable catheter or respiratory gas supply retention means comprising: i. an inflatable retention means to secure the catheter including an inflatable cuff or balloon; ii. an inflation line to said inflatable retention means; iii. an injection port with a proximal end including an interface to accept input of a fluid, a one-way non-return valve, and a distal end in fluid connection with said inflation line, to allow input of fluid to inflate said retention means including inflatable cuff or balloon; and iv. a pressure release means to prevent inflation of said inflatable retention means beyond a defined pressure. including the steps: a) The catheter or respiratory gas supply means is inserted into said patient; b) a syringe containing a fluid is connected to said injection port; c) said syringe is compressed to cause said fluid to inject into said adaptor and into said inflation cuff; and d) said compression of said syringe continues until said pressure release means is activated or the user is satisfied said cuff is properly inflated. ### Claim 16 (depends on 15) The method of claim 15 where said pressure release means is one of an umbrella valve, a rubber flap, a spring-loaded traps and a duckbill valve. ### Claim 17 (depends on 15) The method of claim 15 where the pressure release means opens at or above 20 cmH2O. ### Claim 18 (depends on 15) The method of claim 15 where said catheter or respiratory gas supply means includes one of a Foley catheter, an endotracheal tube, a tracheostomy tube or a laryngeal mask airway. ### Claim 19 A method for assessing proper insertion into a space in a body by a user, of a catheter or respiratory gas supply means including an inflatable retention means, an inflation line connecting to said inflatable retention means and an inflation port, said inflation port comprising a proximal end including an interface to accept input of a fluid, a one-way non-return valve, and a distal end in fluid connection with said inflation line, to allow input of fluid to inflate said retention means including inflatable cuff or balloon; and a pressure release means to prevent inflation of said inflatable retention means beyond a defined pressure, including the steps: a) the user inserts said catheter or respiratory gas supply means; b) the user attempts to inflate retention means with fluid injection source, injecting a known amount of fluid, less than an amount required to adequately fill the retention means; c) the user observes said pressure release means while inflating; d) should the user observe fluid to leak out or said pressure release means to open, the catheter or respiratory gas supply means is judged not to have been positioned properly and said inflatable retention means is deflated, said catheter or respiratory gas supply means is repositioned and the steps are repeated. ### Claim 20 (depends on 19) The method of claim 19 where said catheter or respiratory gas supply means includes one of a Foley catheter, an endotracheal tube, a tracheostomy tube or a laryngeal mask airway.