Patent Publication Number: US-2022218890-A1

Title: Urinary Drainage System with Air Pressure Apparatus

Description:
PRIORITY 
     This application claims the benefit of priority to U.S. Provisional Application No. 63/135,458, filed Jan. 8, 2021, which is incorporated by reference in its entirety into this application. 
    
    
     BACKGROUND 
     Urine transport from a patient to a urine collection bag may be facilitated by gravity. In some configurations, the collection bag and drainage tubing connecting to the patient must be sloped downward with the bag at a lower height than the patient&#39;s bladder. However due to normal patient movement over time, the drainage tubing may incur tubing loops that lead to a volume of urine that is retained within the tubing and does not reach the bag. The retained urine within the tubing can lead to inaccurate urine output measurements and increased pressure on the patients&#39; bladder to expel the urine into the bag. The increased pressure can lead to injury if the pressure is not alleviated in a timely manner. Current methods to clear the retained urine within the tubing require clinicians to lift the tubing to push the fluid towards the bag. It would be beneficial to the patient and the clinician to have a system that ensures all urine from the bladder gets transported to the collection bag within additional steps. Disclosed herein is an apparatus, a system and method of use that address the foregoing. 
     SUMMARY 
     Disclosed herein is a urinary drainage system including an air pressure apparatus having a connector having an elongate connector body, including a proximal end having a proximal opening, a distal end including a distal opening and a connector lumen. The connector lumen includes a larger proximal lumen diameter and a smaller distal lumen diameter. The air pressure apparatus includes an air intake adapter having an elongate adapter body, including a proximal end having a proximal opening configured to be coupled to the distal end of the connector, a distal end having a distal opening, the adapter body having an adapter lumen and an air intake port. The air intake port is in fluid communication with the adapter lumen, the adapter lumen having a larger proximal lumen diameter and a smaller distal lumen diameter. 
     In some embodiments, the urinary drainage system includes a catheter in fluid communication with a fluid collecting bag. 
     In some embodiments, the catheter is coupled to the proximal end of the connector. 
     In some embodiments, the catheter is coupled to the proximal end of the connector by a first drainage tube. 
     In some embodiments, the fluid collecting bag is coupled to the distal end of the adapter. 
     In some embodiments, the fluid collecting bag is coupled to the distal end of the adapter by a second drainage tube. 
     In some embodiments, the connector lumen is in fluid communication with the adapter lumen when the distal end of the connector is coupled to the proximal end of the adapter. 
     In some embodiments, the proximal lumen diameter of the adapter is larger than the distal lumen diameter of the connector. 
     In some embodiments, the coupling of the adapter to the connector generates a luminal space within the adapter, the luminal space being in fluid communication with the air intake port. 
     In some embodiments, the air intake port is perpendicular to the distal end of the connector. 
     In some embodiments, a volume of positive pressurized air is received through the air intake port, creating a vortex of positive air pressure within the luminal space. 
     In some embodiments, the distal end of the connector includes external threads thereon and the proximal end of the adapter includes internal threads therein, the external threads and internal threads configured to couple the connector to the adapter. 
     In some embodiments, the connector includes one or more lateral ports perpendicular to the connector lumen, the one or more lateral ports being in fluid communication with the connector lumen and being configured to draw fluid. 
     In some embodiments, the proximal end of the connector includes a catheter attachment. 
     In some embodiments, the connector lumen is in fluid communication with the catheter or the first drainage tube. 
     In some embodiments, the proximal end of the connector is configured to slidably receive the catheter or the first drainage tube. 
     In some embodiments, the adapter lumen is in fluid communication with the second drainage tube. 
     In some embodiments, the distal end of the adapter is configured to slidably receive the second drainage tube. 
     In some embodiments, the connector and the adapter are disposable or reusable. 
     Also disclosed herein is a method for clearing a fluid column from a drainage tube including coupling an air pressure apparatus of a urinary drainage system to a catheter and to a fluid collecting bag, the air pressure apparatus maintaining fluid communication between the catheter and the fluid collecting bag, the air pressure apparatus having a connector including a connector lumen, the connector coupled to an adapter having an adapter lumen, an air intake port and a luminal space. The method further includes passing an acquired volume of fluid from the catheter to the fluid collecting bag, providing a volume of positive air pressure into the luminal space of the adapter, and clearing a first drainage tube of a residual volume of fluid. 
     In some embodiments, coupling the air pressure apparatus of the urinary drainage system to the catheter and to the fluid collecting bag includes a proximal end of the connector slidably receiving a first drainage tube coupled to the catheter and a distal end of the adapter slidably receiving a second drainage tube coupled to the fluid collecting bag. 
     In some embodiments, coupling the air pressure apparatus of the urinary drainage system to the catheter and to the fluid collecting bag includes the proximal end of the connector slidably receiving the catheter and the distal end of the adapter slidably receiving the second drainage tube. 
     In some embodiments, the connector lumen and the adapter lumen are in fluid communication with the catheter and the fluid collecting bag. 
     In some embodiments, passing the acquired volume of fluid includes passing by gravity flow. 
     In some embodiments, providing a volume of positive air pressure includes coupling an air hose connected to a motor to the air intake port of the adapter. 
     In some embodiments, providing a volume of positive air pressure includes providing a volume of positive air pressure through the air intake port. 
     In some embodiments, providing a volume of positive air pressure includes creating a vortex of positive air pressure around the distal end of the connector. 
     In some embodiments, clearing the first drainage tube of the residual volume of fluid includes using the vortex of positive air pressure to draw the volume of fluid into the connector lumen and push the entire volume of fluid out of a distal end of the adapter. 
     These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail. 
    
    
     
       DRAWINGS 
       A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates a side view of a urinary drainage system including an air pressure apparatus, in accordance with some embodiments. 
         FIG. 2  illustrates a perspective view of the air pressure apparatus, in accordance with some embodiments. 
         FIG. 3  illustrates a cross sectional view of the air pressure apparatus, in accordance with some embodiments. 
         FIG. 4  illustrates an exemplary method of transporting an entirety of a volume of fluid through the air pressure apparatus, in accordance with some embodiments. 
         FIG. 5  illustrates a side view of the air pressure apparatus, in accordance with some embodiments. 
         FIG. 6  illustrates a flow chart of an exemplary method of clearing a volume of fluid from a drainage tube, in accordance with some embodiments. 
     
    
    
     DESCRIPTION 
     Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. 
     Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. 
     With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, an apparatus disclosed herein includes a portion of the apparatus intended to be near a clinician when the apparatus is used on a patient. Likewise, a “proximal length” of, for example, the apparatus includes a length of the apparatus intended to be near the clinician when the apparatus is used on the patient. A “proximal end” of, for example, the apparatus includes an end of the apparatus intended to be near the clinician when the apparatus is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the apparatus can include the proximal end of the apparatus; however, the proximal portion, the proximal-end portion, or the proximal length of the apparatus need not include the proximal end of the apparatus. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the apparatus is not a terminal portion or terminal length of the apparatus. 
     With respect to “distal,” a “distal portion” or a “distal-end portion” of, for example, an apparatus disclosed herein includes a portion of the apparatus intended to be near or in a patient when the apparatus is used on the patient. Likewise, a “distal length” of, for example, the apparatus includes a length of the apparatus intended to be near or in the patient when the apparatus is used on the patient. A “distal end” of, for example, the apparatus includes an end of the apparatus intended to be near or in the patient when the apparatus is used on the patient. The distal portion, the distal-end portion, or the distal length of the apparatus can include the distal end of the apparatus; however, the distal portion, the distal-end portion, or the distal length of the apparatus need not include the distal end of the apparatus. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the apparatus is not a terminal portion or terminal length of the apparatus. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. 
       FIG. 1  illustrates a side view of a urinary drainage system  100  including an air pressure apparatus  110 , in accordance with some embodiments. In some embodiments, the urinary drainage system  100  may include a catheter  102  in fluid communication with an air pressure apparatus  110  and a fluid collecting bag  104 . In some embodiments, the catheter  102  may be configured to be coupled to the air pressure apparatus  110  by a first drainage tube  160 . In some embodiments, the air pressure apparatus  110  may be configured to be coupled to the fluid collecting bag  104  by a second drainage tube  162 . In some embodiments, the urinary drainage system  100  may be configured to drain a volume of fluid from a patient and allow fluid flow from the catheter  102  into the fluid collecting bag  104 . For example, the catheter  102  may be configured to be inserted into an orifice within the body of a patient to drain body fluid from the catheter  102  to the fluid collecting bag  104 . Exemplary catheters include indwelling catheters, Foley catheters, balloon catheters, peritoneal drainage catheters, or the like. Exemplary body fluids can include urine, blood, interstitial fluid, peritoneal fluid, saliva, mucus, or the like. 
       FIG. 2  illustrates a perspective view of the air pressure apparatus  110 , in accordance with some embodiments. In some embodiments, the air pressure apparatus  110  includes a connector  120  and an air intake adapter  140  (“adapter”) configured to be coupled together. In some embodiments, the air pressure apparatus  110  may be configured to clear a volume of fluid from a drainage tube. In some embodiments, the connector  120  and the adapter  140  may be coupled together in a press fit, a snap fit, an interference fit or the like. In some embodiments, the connector  120  includes a connector body  122 , having a proximal end  124 , a distal end  126  and a connector lumen  128  therethrough. The connector body  122  may include an elongate body. In some embodiments, the proximal end  124  includes a catheter attachment  130 , configured to couple to a catheter  102 . In some embodiments, the catheter attachment  130  may be configured to slidably receive a catheter  102  thereon. In some embodiments, the catheter attachment  130  may be configured to slidably receive the first drainage tube  160  thereon. 
     The adapter  140  includes an adapter body  142 , having a proximal end  144 , a distal end  146  and an adapter lumen  148  therethrough. In some embodiments, the adapter body  142  may include an elongate body. In some embodiments, the distal end  146  may be configured to couple with the second drainage tube  162 . In some embodiments, the distal end  146  may be configured to slidably receive the second drainage tube  162 , the second drainage tube  162  in fluid communication with the fluid collection bag. The proximal end  144  of the adapter body  142  may be configured to couple to the distal end  126  of the connector body  122 . In some embodiments, the proximal end  144  of the adapter body  142  may be configured to detachably couple to the distal end  126  of the connector body  122 . In some embodiments, the proximal end  144  of the adapter body  142  may be configured slidably receive the distal end  126  of the connector body  122 . In some embodiments, wherein the connector  120  is slidably engaged by the adapter  140 , the connector lumen  128  and the adapter lumen  148  maintain fluid communication between the catheter  102  and the fluid collecting bag  104 . In some embodiments, the adapter body  142  may include an air intake port  150  in fluid communication with the adapter lumen  148 , that will be described in more detail herein. The air intake port  150  is perpendicular to the adapter lumen  148 , advantageously preventing backward airflow into the connector  120  and the first drainage tube  160 . 
     In some embodiments, as illustrated in  FIG. 2 , the connector body  122  may include one or more lateral ports  132  in fluid communication with the connector lumen  128 . The one or more lateral ports  132  may be configured to extend laterally from the connector body  122 . The one or more lateral ports  132  may be configured to allow a clinician to withdraw a fluid sample from the connector lumen  128  as a volume of fluid sample passes therethrough. The one or more lateral ports  132  may be configured to be perpendicular to the connector lumen  128 . In some embodiments, the one or more lateral ports  132  may be configured to detachably couple with a Luer lock syringe, other medical devices or the like. 
       FIG. 3  illustrates a cross sectional view of the air pressure apparatus  110 , in accordance with some embodiments. In some embodiments, a portion of the distal end  126  of the connector body  122  may include external threads  134  and a portion of the proximal end  144  of the adapter body  142  may include internal threads  152  configured to receive the external threads  134  configured to couple the connector body  122  to the adapter body  142 . In some embodiments, the coupling of the distal end  126  of the connector body  122  to the proximal end  144  of the adapter body  142  creates an airtight and fluid seal between the connector body  122  and the adapter body  142 , configured to allow a volume of fluid to pass through the connector lumen  128  and the adapter lumen  148 . 
     In some embodiments, the connector lumen  128  has a proximal lumen diameter  129  and a distal lumen diameter  131 . In some embodiments, the proximal lumen diameter  129  may be greater than or equal to the distal lumen diameter  131 . In some embodiments, the adapter lumen  148  includes a proximal lumen diameter  154  and a distal lumen diameter  156 . In some embodiments, the proximal lumen diameter  154  may be greater than or equal to the distal lumen diameter  156 . In some embodiments, the proximal lumen diameter  156  of the adapter  140  is greater than the distal lumen diameter  131  of the connector  120 . When the connector  120  is coupled to the adapter  140 , the difference between the proximal lumen diameter  156  of the adapter  140  and the distal lumen diameter  131  of the connector  120  creates a luminal space  158  within the adaptor body  142 , around the distal end  126  of the connector  120 . The luminal space  158  is in fluid communication with the air intake port  150  and the adapter lumen  148 . In some embodiments, the air intake port  150  may be configured to receive a volume of pressurized air therein and form a vortex of positive pressure air around the distal end  126  of the connector  120  within the luminal space  158 , configured to push a volume of fluid from the distal end  126  of the connector  120 , through the adapter  140  to the second drainage tube  162 . In some embodiments, the proximal lumen diameter  154  and the distal lumen diameter  156  of the adapter  140  may be configured to be increased or decreased to ensure adequate fluid output into the fluid collecting bag  104 . 
       FIG. 4  illustrates an exemplary method of transporting an entirety of a volume of fluid through the air pressure apparatus  110 , in accordance with some embodiments. In some embodiments, a patient may void a volume of fluid through the catheter  102  in fluid communication with the air pressure apparatus  110  and the fluid collecting bag  104 . In some embodiments, the catheter  102  may be in fluid communication with the first drainage tube  160  while the first drainage tube  160  is coupled to the proximal end of the connector  120 . The connector  120  is coupled to the adapter  140 , maintaining fluid communication between the first drainage tube  160  and the distal end of the adapter  140 . The distal end of the adapter  140  is coupled to the second drainage tube  162 . An air hose  180 , configured to provide the volume of pressurized air through the air intake port  150  may be coupled to the air intake port  150 . A volume of fluid may flow from the catheter  102 , through the first drainage tube  160 , through the connector lumen  128  and the adapter lumen  148  to the fluid collecting bag  104  by gravity flow. It can be appreciated that fluid flow may occur from the catheter  102  to the fluid collecting bag  104  by other mechanisms, all of which are considered. However, a portion of the volume of fluid may remain within the first drainage tube  160 . The portion of the volume of fluid remaining within the first drainage tube  160  will be referred herein as the residual volume of fluid. 
     As illustrated in  FIG. 4 , to remove the residual volume of fluid remaining within the first drainage tube  160 , a volume of pressurized air may be received through the air intake port  150  into the luminal space  158 . The volume of pressurized air may be configured to create a positive pressure vortex around the distal end  126  of the connector  120 . The positive pressure vortex may be configured to draw the residual volume of fluid from the first drainage tube  160  into the connector lumen  128 , through the adapter lumen  148  into the second drainage tube  162 . The positive pressure vortex ensures that the entirety of the volume of fluid, including the residual volume of fluid, passes from the distal end  126  of the connector  120 , through the adapter  140  to the second drainage tube  162 . Advantageously, the positive pressure vortex pushes the residual volume of fluid through the adapter  140  and into the second drainage tube  162 , preventing fluid backflow into the first drainage tube  160 . 
       FIG. 5  illustrates a side view of the air pressure apparatus  110 , in accordance with some embodiments. In some embodiments, the connector body  122  and the adapter body  142  may be made from plastic such as polypropylene, polystyrene or the like. In some embodiments, the connector body  122  and adapter body  142  may be injection molded, extruded, 3D printed or the like. In some embodiments, the proximal end  144  of the adapter  140  may be configured to be coupled to the distal end  126  of the connector  120  through snap fit, press fit, interference fit, magnetic fit or the like. In some embodiments, the adapter  140  may be configured to have a locking mechanism configured to lock the connector  120  to the adapter  140  when the proximal end  144  of the adapter  140  slidably receives the distal end  126  of the connecter  120 . In some embodiments, the connector  120  and the adapter  140  may be configured to be disposable or reusable. 
       FIG. 6  illustrates a flow chart of an exemplary method of clearing a volume of fluid from a drainage tube, in accordance with some embodiments. The method  200  includes coupling a catheter  102  to the proximal end of an air pressure apparatus  110  of the urinary drainage system  100  and coupling a fluid collecting bag  104  to the distal end of the air pressure apparatus  110  wherein fluid communication occurs between the catheter  102  and the fluid collecting bag  104  (block  202 ). In some embodiments, the catheter  102  may be coupled to the proximal end of the air pressure apparatus  110  by the first drainage tube  160 . In some embodiments, the fluid collecting bag  104  may be coupled to the distal end of the air pressure apparatus  110  by the second drainage tube  162 . In some embodiments, the air pressure apparatus  110  includes the connector  120  being coupled to the adapter  140 . In some embodiments, the connector  120  includes the connector lumen  128  and the adapter  140  includes the adapter lumen  148  wherein the connector lumen  128  and the adapter lumen  148  are in fluid communication with the catheter  102  and the fluid collecting bag  104 . In some embodiments, the adapter  140  may be configured to slidably receive the connector  120  so that the luminal space  158  within the adapter  140  is around the distal end  126  of the connector  120  when the distal end  126  of the connector  120  is received by the adapter  140 . In some embodiments, the adapter  140  further includes the air intake port  150  in fluid communication with the luminal space  158 , the air intake port  150  configured to receive therein a volume of positive air pressure configured to create the vortex of positive air pressure within the luminal space  158 . 
     The method  200  includes passing an acquired volume of fluid from the catheter  102  to the fluid collecting bag  104  (block  204 ). In some embodiments, passing includes passing an acquired volume of fluid by gravity flow. The method  200  includes providing a positive volume of air pressure through the air intake port  150  around the luminal space in the adapter (block  206 ). In some embodiments, providing includes creating a vortex of positive air pressure within the luminal space  158  around the distal end  126  of the connector  120 . In some embodiments, providing includes providing the volume of positive air pressure until the entire acquired volume of fluid is contained within the fluid collecting bag  104 . The method  200  includes clearing the first drainage tube  162  of the residual volume of fluid (block  208 ). In some embodiments, clearing includes using the vortex of positive air pressure to draw the residual volume of fluid through the connector lumen  148  and the adapter lumen  128  into the fluid collecting bag  104 . 
     While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.