Patent Publication Number: US-2022218974-A1

Title: Connector for Selective Occlusion of Drainage Tube

Description:
PRIORITY 
     This application claims the benefit of priority to U.S. Provisional Application No. 63/135,447, filed Jan. 8, 2021, which is incorporated by reference in its entirety into this application. 
    
    
     SUMMARY 
     Briefly summarized, embodiments disclosed herein are directed to a valved connector for selective occlusion of a drainage lumen to prevent pressure reflux during active clearance of dependent loops within fluid drainage systems. 
     Fluid drainage systems generally include a flexible drainage tube configured to provide fluid communication with a collection container. Due to the flexibility of the drainage tube, and/or normal patient movements, sections of positive incline can form, where drainage fluid can accumulate, termed “dependent loops.” Fluid caught in these dependent loops can lead to various problems. For example, fluid caught in the drainage tube fails to reach the collection container leading to inaccurate fluid output measurements and misdiagnosis of patients or mis-prescribing of drugs. For dependent loops in urine drainage systems, the bladder must push against the pressure of the dependent loop to further excrete urine. This can be uncomfortable for the patient and can lead to injury if the pressure is not alleviated in a timely manner. Further, stagnant fluid within the drainage tube can be a source of pathogens leading to an increased risk of catheter associated urinary tract infections (CAUTI). CAUTI can be highly detrimental to the patient as well as incurring increased costs for additional treatment. 
     Current practice is for clinicians to manipulate the tubing to urge the fluid caught in the dependent loop towards the collection container. If performed incorrectly, fluid reflux can occur causing infections and complications. Further, there is also an added responsibility on the clinician to perform the manipulation correctly and in a timely manner. Active drainage systems have been developed that introduce a positive air flow to a distal end of the drainage tube to urge fluid through the system to the collection container, clearing these dependent loops. However, the air pressure within the system can cause increased pressure within the patient bladder leading to reflux, increased discomfort and potentially introducing infections to the patient. 
     Disclosed herein is a connector for a fluid drainage system including, a body defining a drainage lumen extending along a longitudinal axis from a distal portion to a proximal portion, a piston housing including an inlet in fluid communication with a source of pressurized air, a piston slidably engaged with the piston housing along a transverse axis between a first position and a second position. In the first position, the piston provides fluid communication between the distal portion and the proximal portion of the drainage lumen, and occludes fluid communication between the inlet and the proximal portion of the drainage lumen. In the second position, the piston occludes fluid communication between the distal portion and the proximal portion of the drainage lumen, and provides fluid communication between the inlet and the proximal portion of the drainage lumen. 
     In some embodiments, the piston includes a piston lumen extending along the longitudinal axis and configured to provide fluid communication between the distal portion and the proximal portion of the drainage lumen when the piston is in the first position. In some embodiments, the connector further includes a pneumatic lumen providing fluid communication between the inlet and the proximal portion of the drainage lumen. In some embodiments, the connector further includes a biasing member configured to bias the piston towards the first position. In some embodiments, the connector further includes a distal coupling disposed at a distal end of the body and configured to releasably engage a proximal end of a catheter to provide fluid communication between the catheter and the distal portion of the drainage lumen. The distal coupling is one of a luer slip fit, threaded, spin-nut, interference fit, press-fit, or snap-fit coupling. 
     In some embodiments the catheter is a Foley catheter configured to drain urine from a bladder of a patient. In some embodiments, the connector further includes a proximal coupling disposed at a proximal end of the body and configured to engage a distal end of a drainage tube, the drainage tube in fluid communication with a collection container. The proximal coupling is one of a luer slip fit, threaded, spin-nut, interference fit, press-fit, or snap-fit coupling. In some embodiments, the connector further includes a guide rail configured to engage a groove to maintain alignment of an axis of the piston channel with the longitudinal axis, the guide rail disposed on one of the piston or an inner surface of the piston housing. 
     Also disclosed is a method of draining a fluid from a catheter to a collection container including, draining a fluid along a longitudinal axis of a connector, from a distal drainage lumen to a proximal drainage lumen, applying a pressurized fluid to an inlet of the connector, sliding a piston along an axis extending perpendicular to the longitudinal axis from a first position to a second position, occluding fluid flow between the distal drainage lumen and the proximal drainage lumen, and providing fluid communication between the inlet and the proximal drainage lumen. 
     In some embodiments, the distal drainage lumen is in fluid communication with a lumen of a catheter and the proximal drainage lumen is in fluid communication with a lumen of a drainage tube, the drainage tube coupled to a collection container. The catheter is a Foley catheter. The piston includes a piston lumen extending from a first side to a second side and configured to provide fluid communication between the distal drainage lumen and the proximal drainage lumen when the piston is in the first position. In some embodiments, the method further includes a pneumatic lumen providing fluid communication between the inlet and the proximal drainage lumen. In some embodiments, the method further includes a biasing member configured to bias the piston towards the second position. 
     In some embodiments, the method further includes a distal coupling disposed at a distal end of the connector and a proximal coupling disposed at a proximal end of the connector. The distal coupling or the proximal coupling is one of a luer slip fit, threaded, spin-nut, interference fit, press-fit, or snap-fit coupling. The piston is disposed within a piston housing of the connector, the piston includes one of a facet, guiderail, or groove configured to engage an inner surface of the piston housing to prevent rotational movement about the axis extending perpendicular to the longitudinal axis. 
    
    
     
       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  shows an exemplary fluid drainage system, in accordance with embodiments disclosed herein. 
         FIG. 2  shows a perspective view of a connector shown in wire frame, in accordance with embodiments disclosed herein. 
         FIG. 3  shows a side view of a connector, in accordance with embodiments disclosed herein. 
         FIG. 4  shows an exploded view of a connector, in accordance with embodiments disclosed herein. 
         FIG. 5  shows a cross-section view of a connector, in accordance with embodiments disclosed herein. 
         FIG. 6  shows a cross-section view of a connector in a first position, in accordance with embodiments disclosed herein. 
         FIG. 7  shows a cross-section view of a connector in a second position, in accordance with embodiments disclosed herein. 
     
    
    
     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, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter. 
     With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter. 
     To assist in the description of embodiments described herein, as shown in  FIG. 2 , a longitudinal axis extends substantially parallel to an axial length of the drainage lumen. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes. 
     As used herein, the term “fluid” can include a gas, liquid, or combination thereof. 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  shows an exemplary drainage system (“system”)  10 , configured to drain a fluid from a patient. The system  10  generally includes a catheter  12 , a drainage tube (“tube”)  20 , and a collection container (“container”)  30 . Exemplary catheters  12  include indwelling catheters, Foley catheters, balloon catheters, peritoneal drainage catheters, or the like, and are configured to be inserted into an orifice within the body of a patient to drain a fluid therefrom. Exemplary fluids can include water, blood, plasma, urine, interstitial fluid, saliva, mucus, pus, or the like. In an embodiment, the catheter  12  can be inserted through the urethra and into a bladder of a patient to drain a fluid, e.g. urine, therefrom. However, it will be appreciated that embodiments disclosed herein can be used with various fluid drainage systems. The catheter  12  includes an eyelet  16  that provides fluid communication with a lumen  14  of the catheter  12 , and is configured to drain a fluid, e.g. urine, from a patient. 
     The drainage tube  20  extends from a distal end  26  to a proximal end  28  to define an axial length, and defines a lumen  24 . The distal end  26  of the tube  20  can be in fluid communication with a proximal  18  end of the catheter  12 . The proximal end  28  of the tube  20  can be in fluid communication with a collection container  30 , to provide fluid communication between the lumen  14  of the catheter  12  and the collection container  30 . The tube  20  can be formed of rubber, plastic, polymer, silicone, or similar suitable material. The collection container  30  can include a rigid container, a flexible collection bag, or similar suitable container for receiving a fluid, e.g. urine, drained from the catheter  12 . 
     As shown in  FIG. 1 , the flexibility of the drainage tube  20  can result in sections of the tube  20  providing a positive incline relative to the direction of fluid flow therethrough. These positive incline portions allow dependent loops  22  to form, which can lead to fluid pooling within the tube  20 . The fluid caught within the dependent loop  22  can result in various problems, including acting as a source for CAUTI causing agents and pathogens, inaccurate fluid output measurements, mis-diagnoses of patients, or the like. 
     In an embodiment, a pump or similar device can introduce a positive air pressure  40  into the tube lumen  24  to urge the residual fluid of the dependent loop  22  through the tube lumen  24  and into the collection container  30 . Exemplary pumps can include peristaltic pumps, diaphragm pumps, solenoid pumps, compressors, medical air lines, piston pumps, syringes, bellows, reciprocating pumps, combinations thereof, or the like. Before the positive air pressure  40  is introduced, the lumen  14  of the catheter  12  must be isolated to prevent the positive air pressure  40  flowing distally through the catheter  12  and into the patient, causing discomfort or trauma. 
       FIGS. 2-7  show various details of an embodiment of a connector piece (“connector”)  100  disposed between the catheter  12  and the drainage tube  20 , and configured to automatically isolate a fluid path communicating with a catheter  12 , when a positive air pressure  40  is applied, to clear dependent loops  22 . The connector  100  generally includes a body  110  defining a substantially cylindrical shape extending along a longitudinal axis between from a distal end  112  to a proximal end  114 . The body  110  can define a central drainage lumen  120  extending along a longitudinal axis and providing fluid communication between a distal end  112  and a proximal end  114 . 
     The distal end  112  of the body  110  can include a distal coupling  116  configured to releasably engage a proximal end of the catheter  12  and provide fluid communication between the lumen  14  of the catheter  12  and the drainage lumen  120 . The proximal end  114  of the body  110  can include a proximal coupling  118  configured to releasably engage a distal end  26  of a drainage tube  20 , and provide fluid communication between the drainage lumen  120  of the connector  100  and the lumen  24  of the drainage tube  20 . One of the distal coupling  116  or the proximal coupling  118  can include luer slip fit, threaded connector, spin-nut, interference fit, press-fit, snap-fit, or similar connector configured to releasably couple the connector  100  to one of the catheter  12  or the drainage tube  20  with a fluid tight fitting. 
     In an embodiment, the body  110  further includes a piston housing  130  that defines a substantially cylindrical shaped piston cavity  142  extending along an axis that extends perpendicular to the axis of the drainage lumen  120 . In an embodiment the piston cavity  142  extends along a transverse axis, although other axes extending perpendicular to the longitudinal axis are also contemplated. The piston cavity  142  can communicate with the drainage lumen  120 . The piston cavity  142  can define a substantially circular cross-sectional shape, however it will be appreciated that other cross-sectional shapes are also contemplated. 
     The body  110  can further include an inlet  140  configured to provide fluid communication between a pump, or similar source of positive air pressure  40  and the piston cavity  142 . The inlet  140  can include a threaded connector  138 , or similar connector, configured to couple with a positive air pressure fluid line, or the like. Exemplary positive air pressure fluid lines can include, medical air lines, pumps, syringes, or the like. 
     In an embodiment, the piston housing  130  can further include a recess  144 , communicating with the drainage lumen  120 , and extending perpendicular therefrom. The recess  144  can define a substantially circular cross-sectional shape, however it will be appreciated that other cross-sectional shapes are also contemplated. An axis of the piston cavity  142  can align with an axis of the recess  144 , disposed opposite the piston cavity  142  across the drainage lumen  120 . In an embodiment, the piston cavity  142  can align with the recess  144  along a transverse axis, although it will be appreciate that other axes are contemplated. 
     In an embodiment, the body  110  can further include a pneumatic lumen  146  that extends between the piston cavity  142  and a proximal portion  120 B of the drainage lumen  120  and provides fluid communication therebetween. The pneumatic lumen  146  can extend at an angle of 45° relative to the axis of the drainage lumen  120 . However, greater or lesser angles are also contemplated. Advantageously, the angle of the pneumatic lumen  146  can direct the positive air pressure  40  towards the proximal portion  120 B of the drainage lumen  120  and into the drainage tube  20 , as described in more detail herein. 
     In an embodiment, the body  110  can further include a sample port  148  communicating with the drainage lumen  120  and extending perpendicular therefrom. In an embodiment, the sample port  148  can include a valve configured to control an access or a fluid flow therethrough. Exemplary valves can include check valves, one way valves, flap valves, duckbilled valves, combinations thereof, or the like. The sample port  148  can be configured to allow a clinician to sample a fluid disposed within the drainage lumen  120 . In an embodiment, a pressure sensor can be disposed within the drainage lumen  120  by way of the sample port  148  to detect a fluid pressure disposed within the distal portion  120 A of the drainage lumen  120 . 
     In an embodiment, as shown for example in  FIGS. 2, 4-5 , the connector  100  can further include a piston  150 . The piston  150  can define a cylindrical shape extending along a length and define a substantially circular cross-sectional shape configured to match an inner cross-sectional shape defined by the piston cavity  142 . However, it will be appreciated that other cross-sectional shapes are also contemplated. A diameter of the cross-section of the piston  150  can be the same as, or slightly less than, the diameter of the piston cavity  142  or the recess  144 . As such, the piston  150  can be slidably engaged with the piston cavity  142  or the recess  144 , of the body  110 , along a transverse axis, i.e. an axis that extends perpendicular to the drainage channel  120 . The piston  150  can be slidably engaged with the piston cavity  142  and the recess  144  in a fluid tight engagement, as such a fluid cannot pass between an outer surface of the piston  150  and an inner surface of the piston cavity  142  or the recess  144 . 
     In an embodiment, the piston  150  can slide along an axis extending perpendicular to the longitudinal axis, e.g. a transverse axis, between a first position, as shown in  FIG. 6  and a second position, as shown in  FIG. 7 . In the first position, the piston  150  can be configured to allow a fluid flow between a distal portion  120 A and a proximal portion  120 B of the drainage lumen  120  and to prevent a fluid flow from the inlet  140  from entering the drainage lumen  120 . More specifically a portion of the piston can occlude an opening to the pneumatic lumen  146 , preventing fluid flow therethrough. In the second position, the piston  150  can be configured to prevent a fluid flow between the distal portion  120 A and the proximal portion  120 B of the drainage lumen  120 , and to allow a fluid flow from the inlet  140  to enter the drainage lumen  120  by way of the pneumatic lumen  146 . 
     In an embodiment, the piston  150  can further include a piston lumen  152  extending through the piston  150  from a first side to a second side, and aligning with an axis of the drainage channel, i.e. substantially with a longitudinal axis. In the first position, the piston lumen  152  can align with the drainage lumen  120  to allow a fluid flow between the distal portion  120 A and the proximal portion  120 B. In the second position the piston channel  152  can be disposed within the recess  144  and the piston can occlude fluid flow between the distal portion  120 A and the proximal portion  120 B of the drainage channel  120 . 
     In an embodiment, the connector  100  can include a biasing member  160 , for example a compression spring, rubber grommet, or similar biasing member. The biasing member can bias the piston  150  towards the first position ( FIG. 6 ). In an embodiment, an inner surface of the piston cavity  142  or the recess  144  can include one of a facet (not shown), guiderail  162 , or groove  164  configured to engage a corresponding facet, guiderail or groove disposed on the piston  150  and designed to allow the piston  150  to slide between the first position and the second position but to prevent rotational movement of the piston  150  within the piston cavity  142 , about the transverse axis. Advantageously, this can maintain alignment of the piston lumen  152  with the longitudinal axis. 
     In an exemplary method of use, a connector  100  can be provided, as described herein. A catheter  12  can be fluidly coupled with a distal coupling  116  and a drainage tube  20  can be fluidly coupled with a proximal coupling  118 . A proximal end of the drainage tube  20  can be fluidly coupled with a collection container  30 . 
     The biasing member  160  of the connector  100  can maintain the piston  150  in a first position ( FIG. 6 ) where a fluid can flow freely through the drainage lumen  120 . In the first position, the piston lumen  152  aligns with the drainage lumen  120  to allow a fluid to flow therethrough from the catheter  12  at the distal end  112  to the drainage tube  20  at the proximal end  114 . Also in the first position, a portion of the piston  150  extends through the piston cavity  142  to occlude the pneumatic lumen  146  that extends between the piston cavity  142  and the proximal portion  120 B of the drainage lumen  120 . 
     A user can introduce a pressurized fluid  40  to the connector  100  at the inlet  140 . The force of the pressurized fluid  40  can urge the piston  150  from the first position ( FIG. 6 ) to the second position ( FIG. 7 ), compressing the biasing member  160  within the recess  144 . In the second position, the piston lumen  152  is disposed within the recess  144  and a portion of the piston  150  occludes the drainage lumen  120 . Further, in moving to the second position, the piston  150  moves downward, away from the entrance to the pneumatic lumen  146 , allowing the pressurized air  40  to flow from the inlet  140 , through the pneumatic lumen  146  and into the proximal portion  120 B of the drainage lumen  120 . As such, the pressurized fluid  40  can then enter the drainage lumen  24  and urge fluid through the drainage tube  20  and into the container  30 , clearing any dependent loops  22 . Once the dependent loop  22  is cleared, the pressurized fluid  40  provided at the inlet  140 , can be shut off. The reduced pressure acting on the piston  150  allows the biasing member  160  to transition the piston  150  from the second position to the first position. In the first position, the pressurized fluid  40  is prevented from entering the drainage lumen  120  and patency is restored between the distal portion  120 A and the proximal portion  120 B of the drainage lumen  120 . 
     Advantageously, the piston  150  transitioning between the first position and the second position automatically isolates the catheter lumen  14  from the pressurized fluid  40 , preventing any pressurized fluid  40  from entering the catheter lumen  14 , causing trauma or discomfort. Further, ceasing the pressurized fluid  40  allows the biasing member  160  to automatically restore patency to the drainage lumen  120 , preventing drainage fluid build-up distally of the piston  150 . As such, the connector  100  is configured to prevent accidental fluid communication between the pressurized fluid  40  and the catheter lumen  14 . Similarly, the connector  100  is configured to re-establish fluid communication between the catheter lumen  14  and the drainage tube  20  when the flow of pressurized fluid  40  is ceased. This prevents accidentally leaving the catheter lumen  14  isolated which would quickly lead to fluid buildup and discomfort for the patient. This is important where the patient is incapacitated and cannot notify nursing staff or where the lack of fluid output may go unnoticed. 
     Further, the connector  100  does not require any active control inputs to operate the change in fluid flow paths, only requiring the introduction of a positive air pressure  40  to the pneumatic input  140 . Advantageously, the connector can be used with various positive air pressure dependent loop clearance systems without requiring any communications coupling therebetween, facilitating automation of the dependent loop clearance systems. 
     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.