WO2021150338A1

WO2021150338A1 - Adjustable drainage tubing and collection container to assist drainage of urine

Info

Publication number: WO2021150338A1
Application number: PCT/US2020/066371
Authority: WO
Inventors: Ashley Johannes; Michelle TOURCHAK
Original assignee: C. R. Bard, Inc.
Priority date: 2020-01-21
Filing date: 2020-12-21
Publication date: 2021-07-29

Abstract

Embodiments disclosed herein are directed to a fluid collection system that can relax dependent loops. The system includes a drainage tube and a container, the tube is slidably engaged with an aperture of the container to allow a portion of the tube to be inserted therein. Embodiments can include a seal to prevent fluids or gases escaping, and a sleeve to mitigate introducing CATTTI causing agents into the system. Embodiments can also include a slide assembly to pull a proximal portion of the tube into the collection container. Shortening a communication length of the tube relaxes dependent loops, which can provide a substantially continuous negative incline between the distal end and the proximal end of the drainage tube. Relaxing dependent loops in this way can mitigate urine pooling within the drainage tube that can harbor CAETTI causing agents.

Description

ADJUSTABLE DRAINAGE TUBING AND COLLECTION CONTAINER TO

ASSIST DRAINAGE OF URINE

PRIORITY

[0001] This application claims the benefit of priority to U.S. Patent Application No.

62/963,998, filed January 21, 2020, which is incorporated by reference in its entirety into this application.

SUMMARY

[0002] Briefly summarized, embodiments disclosed herein are directed to a fluid collection system that can relax dependent loops, provide a consistent negative incline along a communication length of a drainage tube, and mitigate urine pooling within the drainage tube. Dependent loops that cause urine to pool within the drainage tube can be a source of catheter associated urinary tract infection (“CAUTI”) causing agents such as bacteria, microbes, and the like. Hospital Acquired Infections (“HAT’), such as CAUTI, are detrimental to the patient, and also incur extra costs in treating these additional complications.

[0003] Disclosed herein is a fluid collection system for collecting a fluid from a patient, including a collection container and a drainage tube having a distal end designed for connection to a catheter, and a proximal end in fluid communication with the collection container, wherein a proximal portion of the drainage tube is slidably engaged with the container.

[0004] In some embodiments, the fluid collection system further includes a seal configured to maintain contact between an outer surface of the proximal portion of the drainage tube and an inner surface of an aperture of the container. In some embodiments, the seal prevents the introduction of microbes into the collection container between the outer surface of the proximal portion of the drainage tube and the inner surface of the aperture. The seal prevents one of a fluid or a gas escaping from the collection container between the outer surface of the proximal portion of the drainage tube and the inner surface of the aperture. The seal is one of an O-ring or a grommet. The seal is retained within a recess disposed within the inner surface of the aperture. The catheter is configured to be inserted through a urethra and into a bladder of the patient. The catheter is one of an indwelling catheter, Foley catheter, a balloon catheter, and a peritoneal catheter. [0005] In some embodiments, an axial length of the drainage tube between the proximal end and the distal end is greater than a longest dimension of the collection container. In some embodiments, the fluid collection system further includes a sleeve slidably engaged with drainage tube between the collection container and the distal end. In some embodiments, the sleeve defines a lumen configured to receive a second portion of the drainage tube disposed therethrough. The sleeve is formed of a compliant material, and configured to allow a user to apply a pressure to an outer surface of the sleeve to grip a portion of the drainage tube disposed therein.

[0006] In some embodiments, the fluid collection system further includes a slide assembly configured to pull the portion of the drainage tube through the aperture of the collection container. The slide assembly includes a tab, a button, and a collar, the button coupled with a first end of the tab, the tab extending through a slot disposed in a side wall of the collection container, a second end of the tab coupled with the collar. The collar is coupled with a proximal portion of the drainage tube disposed within the collection container. The button is disposed on an outer surface of the collection container and configured to be urged along an axial length of the slot. In some embodiments, the fluid collection system further includes a slot seal configured to maintain contact between an outer surface of the tab and an inner surface of the slot. The slot seal prevents the introduction of CAUTI causing agents into the collection container between the outer surface of the tab and the inner surface of the slot. The slot seal prevents one of a fluid or a gas escaping from the collection container between the outer surface of the tab and the inner surface of the slot. The slot extends between 10%- 90% of a length of the side wall of the collection container.

[0007] Also disclosed is a method of relaxing dependent loops from a fluid collection system, including providing a collection container, a drainage tube, and a sleeve, the drainage tube extending from a distal end to a proximal end and in fluid communication with the collection container, the drainage tube slidably engaged with an aperture of the collection container, and the sleeve slidably engaged with the drainage tube and disposed between the collection container and the distal end, grasping an outer surface of the sleeve, gripping a portion of the drainage tube within a lumen of the sleeve, urging a proximal portion of the drainage tube proximally through the aperture and into the collection container, and shortening a communication length of the drainage tube between the collection container and the distal end. [0008] In some embodiments, the method further includes providing a continuous negative incline between the distal end and the aperture of the collection container. The distal end of the drainage tube is configured to engage a proximal end of a catheter. In some embodiments, the method further includes mitigating the introduction of CAUTI causing agents between an outer surface of the drainage tube and an inner surface of the aperture using a seal.

[0009] Also disclosed is a medical method, including providing a collection container including a slot disposed in a side wall thereof, a drainage tube extending from a distal end to a proximal end, the drainage tube in fluid with the collection container and slidably engaged with an aperture of the collection container, and a slide assembly including a button, a tab, and a collar, sliding the button along a longitudinal axis of the slot, and pulling a portion of the drainage tube through the aperture and into the collection container to shorten the communication length of the drainage tube.

[0010] In some embodiments, the method further includes providing a continuous negative incline between the distal end of the drainage tube and the aperture of the collection container. The button is disposed on an outer surface of the collection container, the tab extends through the slot disposed in the side wall of the collection container, and the collar is coupled with a proximal end of the drainage tube. In some embodiments, the method further includes a slot seal configured to maintain contact between an outer surface of the tab and an inner surface of the slot. The slot seal prevents the introduction of CAUTI causing agents into the collection container between the outer surface of the tab and the inner surface of the slot. The slot seal prevents one of a fluid or a gas escaping from the collection container between the outer surface of the tab and the inner surface of the slot. The slot extends between 10%-90% of a length of the side wall of the collection container.

DRAWINGS

[0011] 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: [0012] FIGS. 1A-1B show an exemplary catheter and fluid collection system, in accordance with embodiments disclosed herein.

[0013] FIG. 1C shows close up detail of the fluid collection system of FIGS. 1A-1B, in accordance with embodiments disclosed herein.

[0014] FIGS. 2A-2B show a fluid collection system, in accordance with embodiments disclosed herein.

[0015] FIGS. 3A-3B show a fluid collection system, in accordance with embodiments disclosed herein.

[0016] FIG. 3C shows close up detail of the fluid collection system of FIGS. 3A-3B, in accordance with embodiments disclosed herein.

DESCRIPTION

[0017] 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.

[0018] 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. [0019] 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.

[0020] 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.

[0021] 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.

[0022] FIGS. 1 A-1B show various details of a fluid collection system (“system”) 100, generally including a catheter 110, a drainage tube (“tube”) 120, and a collection container (“container”) 130. Exemplary catheters 110 include indwelling catheters, Foley catheters, balloon catheters, peritoneal drainage catheters, or the like, and are configured to be inserted into an orifice with the body of a patient to drain a fluid therefrom. In an embodiment, the catheter 110 can be inserted through the urethra and into a bladder of a patient. The catheter 110 includes an eyelet 112 that provides fluid communication with a lumen of the catheter 110, and is configured to drain a fluid, e.g. urine. [0023] The tube 120 extends from a distal end 128 to a proximal end 126 to define an axial length, and defines a lumen. The distal end 128 of the tube 120 is configured to engage a proximal 116 end of the catheter 110. The tube 120 provides fluid communication between the lumen of the catheter 110 and the collection container 130. The tube 120 can be formed of rubber, plastic, polymer, silicone, or similar suitably compliant material. The collection container 130 can include a rigid container, a flexible collection bag, or similar suitable container for receiving a fluid, e.g. urine, drained from the catheter 110. In an embodiment, the container 130 includes graduated markings 102 for measuring a fluid disposed therein.

[0024] As shown in FIG. 1C, in an embodiment, a portion of the tube 120 can be slidably engaged with an aperture 132 disposed in the container 130. In an embodiment, the system 100 includes a seal 134 configured to maintain contact between an outer surface 124 of the tube 120 and an inner surface 136 of the aperture 132 to provide a barrier. In an embodiment, the seal 134 is configured to prevent the introduction of microbes, or similar CAUTI causing agents, into the collection container 130, between the outside surface of the tube 120 and the inside surface of the aperture 132. In an embodiment, the seal 134 is configured to prevent fluids and/or gases escaping from the collection container 130 between the outside surface of the tube 120 and the inside surface of the aperture 132. According to one embodiment (not shown), tube 120 can be inserted into collection container 130 and any excess length of tube 120 can be coiled or otherwise arranged within container 130. (see email 1/21/20)

[0025] FIG. 1C shows a close-up, cross-sectional view of an exemplary seal 134 disposed within the aperture 132, between an inside surface 136 of the aperture 132 and an outside surface 124 of the tube 120. In an embodiment, the seal 134 can be an O-ring or grommet, formed of rubber, silicone or similar suitable material. The seal 134 can be secured within a recess disposed within the inner surface 136 of the aperture 132 and fits securely between the collection container 130 and the tube 120. In an embodiment, the tube 120, the seal 134, or combinations thereof can include a coating configured to mitigate the CAUTI causing agents, improve the contact between the tube 120 and the seal 134, or reduce friction between the tube 120 and the seal 134, or combinations thereof.

[0026] As shown in FIG. 1A, a communication length of tube 120 provides fluid communication between the catheter 110 and the collection container 130. A communication length of the tube 120 can be defined as the length of tube 120 extending from the distal end portion of the tube 120 can be urged into the collection container which shortens the communication length of the tube from (x), as shown in FIG. 1 A, to a second communication length (y), shown in FIG. IB. Shortening the communication length relaxes dependent loops 122 that can form when the tube 120 is relatively too long, e.g. communication length (x). As such, the shorter communication length (y) of tube 120 maintains a consistent negative incline between the distal end 128 of the tube 120 and the aperture 132 and prevents urine from pooling within the tube 120.

[0027] As shown in FIGS. 2A-2B, in an embodiment, the system 100 includes a sleeve

140. In an embodiment, the sleeve 140 can define a substantially cylindrical shape extending along an axial length, parallel to an axis of the tube 120. The sleeve 140 can define a sleeve lumen 142, the tube 120 extends through the sleeve lumen 142 and is slidably engaged therewith. The sleeve 140 can be disposed on the tube 120 between the container 130 and the distal end 128 of the tube 120. The sleeve 140 can be formed of a compliant material, e.g. plastic, polymer, rubber, silicone, or the like.

[0028] In an embodiment, a user can grasp an outer surface 144 of the sleeve 140 and compress the sleeve to grip the portion of the tube 120 disposed within the sleeve lumen 142, as shown by the arrows in FIG. 2 A. The user can then urge a proximal portion of the tube 120 through aperture 132, in to or out of the collection container 130, as shown by the arrows in FIG. 2B. In an embodiment, the user can relax the grip of the sleeve 140 on the tube 120, and slide the sleeve 140 distally along the tube 120. The user can then grasp a second portion of the tube 120, and continue to urge the tube 120 through the aperture 132, as described herein. Advantageously, the sleeve 140 allows the user to grasp and manipulate the tube 120 without directly contacting the tube 120. This prevents contaminating the portion of tube 120 urged through the aperture 132 and into the collection container 130 that could in turn introduce CAUTI causing agents into the system 100.

[0029] As shown in FIGS. 3A-3C, in an embodiment, the system 100 includes a slide assembly 150, comprising a tab 152, a button 154, and a collar 156. The tab 152 can extend through, and be slidably engaged with, an elongate slot 160 disposed in a side wall of the container 130. The tab 152 can be coupled with a button 154 disposed on an outer surface of the side wall of the container 130. The button 154 can be configured to allow a user to urge the slide assembly 150 along the elongate slot 160. The tab 152 can also be coupled with a collar 156. The collar 156 can be configured to couple the slid assembly 150 with a proximal portion of the tube 120, disposed within the container 130. In an embodiment, a user can urge the slide assembly 150, using button 154, from a first position, e.g. a top position shown in FIG. 3 A, to a second position, e.g. a bottom position shown in 3B. Accordingly, the proximal portion of the tube 120, coupled with the slide assembly 150 is pulled through the aperture 132 and into the collection container 130. This in turn shortens the communicative length of the tube 120, as described herein.

[0030] In an embodiment, the slot 160 extends from a first edge of the collection container 130, to a second edge that is opposite the first edge. In an embodiment, the slot 160 extends from a top edge to a bottom edge. In an embodiment, the slot 160 extends along a portion of a side wall of the container 130. In an embodiment, the slot 160 extends between 10%-90% of a length of a side wall of the container 130. In an embodiment, the slot further includes a slot seal 162 configured to maintain a barrier between the tab 152 and an inner surface of the slot 160. In an embodiment, the slot seal 162 is configured to prevent the introduction of microbes, or similar CAUTI causing agents, into the collection container 130, between the outside surface of the tab 152 and the inside surface of the slot 160. In an embodiment, the slot seal 162 is configured to prevent fluids and/or gases escaping from the collection container 130 between the outside surface of the tab 152 and the inside surface of the slot 160.

[0031] In an exemplary method of use, a method of relaxing dependent loops from a fluid collection system is provided. The method includes providing a fluid collection system 100 as described herein, the system 100 including a tube 120 extending from a distal end 128 to a proximal end 126. The distal end 128 of the tube 120 can be in fluid communication with the collection container 130 and slidably engaged with an aperture 132 of the collection container 130. The system 100 can further include a sleeve 140, slidably engaged with the tube 120 and disposed between the collection container 130 and the distal end 128.

[0032] A user can then grasp an outer surface 144 of the sleeve 140 and compress the outer surface 144 to grip a portion of the tube 120 that is disposed within a lumen 142 of the sleeve. The user can then urge a proximal portion of the tube 120 proximally through the aperture 132 and into the collection container 130. Optionally, a user can release the grip on the portion of the tube 120 and slide the sleeve 140 along the tube 120 to a second portion of the tube 120 and repeat the process to urge an additional portion of the tube 120 through the aperture 132. As such, the communication length of the tube 120, between the aperture 132 and the distal end 128 is shortened, as described herein. This relaxes any dependent loops 122 disposed in the tube 120 to provide a substantially continuous negative incline between the distal end 128 of the tube 120 and the aperture 132 of the collection chamber 130.

[0033] In an exemplary method of use, a method of shortening a communication length of tube between a catheter and a collection container is provided including, providing a fluid collection system 100, as described herein, including a tube 120 extending from a distal end 128 to a proximal end 126, the tube 120 in fluid with the collection container 130 and slidably engaged with an aperture 132 of the collection container 130. The system 100 further including a sliding assembly 150 including a button 154, a tab 152, and a collar 156, the button 154 disposed on an outer surface of the collection container 130, the tab 152 extending through an elongate slot 160 disposed in a side wall of the collection container 130, and the collar 156 coupled with the proximal end of the tube. The method includes sliding the button 154 along an axis of the elongate slot 160, pulling a portion of the tube 120 through the aperture 132 and into the collection container 130, which reduces a communication length between a distal end of the tube 120 and the aperture 132 of the collection chamber 130. The method further includes providing a continuous negative incline between the distal end of the tube 120 and the aperture 132 of the collection container 130.

[0034] 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.

Claims

CLAIMS What is claimed is:

1. A fluid collection system for collecting a fluid from a patient, comprising: a collection container; and a drainage tube having a distal end designed for connection to a catheter, and a proximal end in fluid communication with the collection container, wherein a proximal portion of the drainage tube is slidably engaged with the container.

2. The fluid collection system according to claim 1, further including a seal configured to maintain contact between an outer surface of the proximal portion of the drainage tube and an inner surface of an aperture of the container.

3. The fluid collection system according to claim 2, wherein the seal prevents the introduction of microbes into the collection container between the outer surface of the proximal portion of the drainage tube and the inner surface of the aperture.

4. The fluid collection system according to claim 2 or claim 3, wherein the seal prevents one of a fluid or a gas escaping from the collection container between the outer surface of the proximal portion of the drainage tube and the inner surface of the aperture.

5. The fluid collection system according to any claim of claims 2-4, wherein the seal is one of an O-ring or a grommet.

6. The fluid collection system according to any claim of claims 2-5, wherein the seal is retained within a recess disposed within the inner surface of the aperture.

7. The fluid collection system according to any claim of claims 1-6, wherein the catheter is configured to be inserted through a urethra and into a bladder of the patient.

8. The fluid collection system according to any claim of claims 1-7, wherein the catheter is one of an indwelling catheter, Foley catheter, a balloon catheter, and a peritoneal catheter.

9. The fluid collection system according to any claim of claims 1-8, wherein an axial length of the drainage tube between the proximal end and the distal end is greater than a longest dimension of the collection container.

10. The fluid collection system according to any claim of claims 1-9, further including a sleeve slidably engaged with drainage tube between the collection container and the distal end.

11. The fluid collection system according to claim 10, wherein the sleeve defines a lumen configured to receive a second portion of the drainage tube disposed therethrough.

12. The fluid collection system according to claim 10 or claim 11, wherein the sleeve is formed of a compliant material, and configured to allow a user to apply a pressure to an outer surface of the sleeve to grip a portion of the drainage tube disposed therein.

13. The fluid collection system according to any claim of claims 1-12, further including a slide assembly configured to pull the portion of the drainage tube through the aperture of the collection container.

14. The fluid collection system according to claim 13, wherein the slide assembly includes a tab, a button, and a collar, the button coupled with a first end of the tab, the tab extending through a slot disposed in a side wall of the collection container, a second end of the tab coupled with the collar.

15. The fluid collection system according to claim 14, wherein the collar is coupled with a proximal portion of the drainage tube disposed within the collection container.

16. The fluid collection system according to claim 14 or claim 15, wherein the button is disposed on an outer surface of the collection container and configured to be urged along an axial length of the slot.

17. The fluid collection system according to any claim of claims 14-16, further including a slot seal configured to maintain contact between an outer surface of the tab and an inner surface of the slot.

18. The fluid collection system according to claim 17, wherein the slot seal prevents the introduction of CAUTI causing agents into the collection container between the outer surface of the tab and the inner surface of the slot.

19. The fluid collection system according to claim 17 or claim 18, wherein the slot seal prevents one of a fluid or a gas escaping from the collection container between the outer surface of the tab and the inner surface of the slot.

20. The fluid collection system according to any claim of claims 14-19, wherein the slot extends between 10%-90% of a length of the side wall of the collection container.

21. A method of relaxing dependent loops from a fluid collection system, comprising: providing a collection container, a drainage tube, and a sleeve, the drainage tube extending from a distal end to a proximal end and in fluid communication with the collection container, the drainage tube slidably engaged with an aperture of the collection container, and the sleeve slidably engaged with the drainage tube and disposed between the collection container and the distal end; grasping an outer surface of the sleeve; gripping a portion of the drainage tube within a lumen of the sleeve; urging a proximal portion of the drainage tube proximally through the aperture and into the collection container; and shortening a communication length of the drainage tube between the collection container and the distal end.

22. The method according to claim 21, further including providing a continuous negative incline between the distal end and the aperture of the collection container.

23. The method according to claim 21 or claim 22, wherein the distal end of the drainage tube is configured to engage a proximal end of a catheter.

24. The method according to any claim of claims 21-23, further including mitigating the introduction of CAUTI causing agents between an outer surface of the drainage tube and an inner surface of the aperture using a seal.

25. A medical method, comprising: providing: a collection container including a slot disposed in a side wall thereof; a drainage tube extending from a distal end to a proximal end, the drainage tube in fluid with the collection container and slidably engaged with an aperture of the collection container; and a slide assembly including a button, a tab, and a collar; sliding the button along a longitudinal axis of the slot; and pulling a portion of the drainage tube through the aperture and into the collection container to shorten the communication length of the drainage tube.

26. The method according to claim 25, further including providing a continuous negative incline between the distal end of the drainage tube and the aperture of the collection container.

27. The method according to claim 25 or claim 26, wherein the button is disposed on an outer surface of the collection container, the tab extends through the slot disposed in the side wall of the collection container, and the collar is coupled with a proximal end of the drainage tube.

28. The method according to claim 27, further including a slot seal configured to maintain contact between an outer surface of the tab and an inner surface of the slot.

29. The method according to claim 28, wherein the slot seal prevents the introduction of CAUTI causing agents into the collection container between the outer surface of the tab and the inner surface of the slot.

30. The method according to claim 28 or claim 29, wherein the slot seal prevents one of a fluid or a gas escaping from the collection container between the outer surface of the tab and the inner surface of the slot.

31. The method according to any claim of claims 25-30, wherein the slot extends between 10%-90% of a length of the side wall of the collection container.