Drainage systems including reposable containers for draining and collecting bodily fluids

Abstract

A fluid-receiving container assembly configured for use in collecting bodily fluid during a drainage procedure includes a reusable, relatively rigid external shell comprising an outer wall configured to extend around a disposable, relatively flexible container. The outer wall forms an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall. A disposable, relatively flexible container is located in the opening. The rigid external shell includes a first releasable locking structure located on an interior surface of the outer wall and the flexible container comprises a second releasable locking structure located on an exterior surface of a sidewall of the flexible container that is configured to releasably mate with the first releasable locking structure. The second locking structure is engaged with the first locking structure.

Description

DRAINAGE SYSTEMS INCLUDING REPOSABLE CONTAINERS FOR DRAINING AND COLLECTING BODILY FLUIDSTECHNICAL FIELD

[0001] The present specification generally relates to drainage systems and methods for draining bodily fluid from body cavities and, more specifically, to drainage systems and methods including reposable containers for draining and collecting bodily fluids.BACKGROUND

[0002] The pleural cavity is the thin, fluid-filled space between the two pulmonary pleurae (known as visceral and parietal) of each lung. A pleura is a serous membrane that folds back onto itself to form a two-layered membranous pleural sac. The pleural space is normally filled with approximately five to 20 mL of serous fluid. A pleural effusion is a build-up of fluid in the pleural space. A pleural effusion may also be referred to as effusion or pulmonary effusion. The type of fluid that forms a pleural effusion may be categorized as transudate or exudate.

[0003] Peritoneal effusion or ascites refers to an excess collection of fluid in the abdominal cavity. The most common cause of such excess fluid collection is liver cirrhosis and other causes include cancer and pancreatitis.

[0004] There are a number of drainage systems for managing recurrent pleural effusions and ascites at home. Two such systems are the PleurX™ and PeritX™ drainage systems, commercially available from Becton, Dickinson and Company. These systems utilize a catheter and drainage bottles that collect fluid. The catheter is inserted, typically as a simple outpatient procedure, in the chest for draining pleural effusions or in the abdomen for ascites. An end of the catheter stays outside of the body, protected by a dressing. To drain, the end of the catheter is connected to a drainage line on the bottle that is pre-evacuated to provide a negative pressure, and the negative pressure inside the bottle is used to draw out the bodily fluid. However, plastic or glass bottles can take up space for shipping, storage and disposal.SUMMARY

[0005] According to a first embodiment, a fluid-receiving container assembly configured for use in collecting bodily fluid during a drainage procedure includes a reusable, relatively rigidexternal shell comprising an outer wall configured to extend around a disposable, relatively flexible container. The outer wall forms an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall. A disposable, relatively flexible container is located in the opening. The rigid external shell includes a first releasable locking structure located on an interior surface of the outer wall and the flexible container comprises a second releasable locking structure located on an exterior surface of a sidewall of the flexible container that is configured to releasably mate with the first releasable locking structure. The second locking structure is engaged with the first locking structure.

[0006] According to another embodiment, a reusable rigid external shell including an outer wall configured to extend around a disposable, flexible container. The outer wall forming an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall. The rigid external shell includes a plurality of first releasable locking structures located on an interior surface of the outer wall. The plurality of first releasable locking structures is configured to releasably mate with a plurality of second releasable locking structures located on an exterior surface of a sidewall of the flexible container.

[0007] According to another embodiment, a flexible container configured for use in collecting bodily fluid during a drainage procedure includes a sidewall formed of a flexible material. The sidewall forms a body having a fluid-receiving volume. A plurality of second releasable locking structures located on an exterior surface of the sidewall of the container. The plurality of second releasable locking structures is configured to releasably mate with a plurality of first releasable locking structures located on an interior surface of an outer wall of a reusable rigid external shell having a container holding volume that is surrounded by the outer wall.

[0008] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0010] FIG. 1 schematically depicts a drainage system including a fluid-receiving container assembly, according to one or more embodiments shown and described herein;

[0011] FIG. 2 schematically depicts the fluid-receiving container assembly of FIG. 1, according to one or more embodiments shown and described herein;

[0012] FIG. 3A schematically depicts a rigid external shell of the fluid-receiving container assembly of FIG. 1, according to one or more embodiments shown and described herein;

[0013] FIG. 3B schematically depicts a locking structure of the rigid external shell of FIG. 3A, according to one or more embodiments shown and described herein;

[0014] FIG. 4A schematically depicts a flexible container of the fluid-receiving container assembly of FIG. 1, according to one or more embodiments shown and described herein;

[0015] FIG. 4B schematically depicts a locking structure of the flexible container of FIG. 4A, according to one or more embodiments shown and described herein; and

[0016] FIG. 5 depicts a method of using the fluid-receiving container assembly of FIG. 1, according to one or more embodiments shown and described herein.DETAILED DESCRIPTION

[0017] Embodiments described herein are generally directed to fluid-receiving container assemblies that are configured for use in collecting bodily fluid during a drainage procedure. The container assemblies include a reusable, relatively rigid external shell comprising an outer wall configured to extend around a disposable, relatively flexible container. The outer wall forms an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall. A disposable, relatively flexible container is located in the opening. The rigid external shell comprises a first releasable locking structure located on an interior surface of the outer wall and the flexible container comprises a second releasable locking structure located on an exterior surface of a sidewall of the flexible container that is configured to releasably mate with the first releasable locking structure, the second locking structure being engaged with the first locking structure.

[0018] As used herein, the term 0 reposableO refers to a medical product, in this case, a fluidreceiving container assembly that includes a disposable component and a reusable component.The term 0 disposableO refers to the component that is formed with the intention to be used only once and then discarded.

[0019] Referring to FIG. 1, a drainage system 10 for use in draining bodily fluids from body cavities includes a conduit 12 (e.g., an indwelling drainage catheter) that may be partially implanted in a patientOs body and a fluid-receiving container assembly 14 that can be connected to the conduit 12. The fluid-receiving container assembly 14 may be connected to the conduit 12 by a drainage line 16 that extends from the fluid-receiving container assembly 14 to the conduit 12. In some embodiments, the drainage line 16 may include a connector 18 that connects to a one-way valve 20. As an example, the one-way valve 20 may be a valve that is normally closed, but that opens with insertion of the connector 18 to allow bodily fluid to flow through the drainage line 16. A distal end portion 22 of the conduit 12 may be implanted in the patientOs body for pleural or peritoneal drainage or other body location for draining a bodily fluid. In some embodiments, the distal end portion 22 may include a cuff 24 for retention and fenestrations 26 through which the bodily fluid may enter the conduit 12 and be carried from the pleural, peritoneal or other cavity space.

[0020] A suction pump 28 is used to supply negative pressure to the fluid-receiving container assembly 14 to create a vacuum. When the pre-evacuated fluid-receiving container assembly 14 is connected to the drainage line 14 and the conduit 12 a suction is provided to automatically draw bodily fluid from the cavity in which the conduit 12 is inserted toward the fluid-receiving container assembly 14. In some embodiments, the suction pump 28 may be used to provide a constant vacuum through the fluid-receiving container assembly 14 rather than pre-evacuating the fluidreceiving container assembly 14. As used herein, the terms 0 negative pressure^ 0 suction, 0 vacuumO and 0 partial vacuumO may be used interchangeably and refer to a force over an area produced by a difference in pressure. Pressure may be referred to as 0 negativeO in reference to atmospheric pressure (i.e., gauge pressure). It should be noted that while using the fluid-receiving container assembly 14 for draining bodily fluids from body cavities is described primarily herein, the fluid-receiving container assembly 14 may be used to drain bodily fluids from other locations, such as wounds.

[0021] FIG. 2 illustrates a more detailed view of the fluid-receiving container assembly 14 that includes a reusable, relatively rigid external shell 30 comprising an outer wall 32 configured to extend around a disposable, relatively flexible container 34 forming a reposable fluid-receivingcontainer assembly 14. The outer wall 32 forms an opening 36 that is sized and configured to receive the flexible container 34 within a container holding volume 38 surrounded by the outer wall 32. The rigid external shell 30 may or may not be provided with a bottom wall 35 that spans the opening 36 at an end 37. The external shell 30 may be formed of any suitable material, such as a hard plastic (e.g., polyethylene terephthalate glycol), metal (e.g., stainless steel), etc.

[0022] The disposable, relatively flexible container 34 is located in the opening 36 and container holding volume 38. It should be noted that while the rigid external shell 30 and flexible container 34 are illustrated as being round in cross-section (e.g., circular), they may be any suitable cross-sectional shape, such as polygonal (e.g., square, rectangular, etc.), oval, irregular shapes. The flexible container 34 may be formed of any suitable flexible material that is configured to be disposable, such as a plastic (e.g., silicone, polyvinyl chloride, etc.), paper, etc. As used herein, the term 0 flexibleO means configured to easily bend with a manual force without breaking. The term I rigid means configured to not easily bend with a manual force relative to the term 0 flexible.O In some embodiments, the flexible container 34 may be flexible, but not resilient so that the flexible container can be folded and / or crushed and remain folded and / or crushed to reduce a footprint of the flexible container 34 when being discarded and to reduce the footprint when shipping to the user. In some embodiments, the flexible material forming the flexible container 34 may be biodegradable, or capable of decaying through action of living organisms.

[0023] Referring also to FIGS. 3A-4B, the rigid external shell 30 includes a first releasable locking structure 40 located on an interior surface 42 of the outer wall 32 and the flexible container 34 includes a second releasable locking structure 44 located on an exterior surface 46 of a sidewall 48 of the flexible container 34 that is configured to releasably mate with the first releasable locking structure 40. In the illustrated example, the first and second locking structures 40 and 44 are dovetail-type locking structures, where the first locking structure 40 is a female locking structure comprising a bracket, also represented by element 40, having a tapered slot 50 and the second locking structure 44 is a male locking structure having a correspondingly tapered projection or locking tab 52 that is sized and configured to be matingly received within the tapered slot 50 by sliding the locking tab 52 into the slot 50 from the top. Any suitable interlocking structures may be used rather than the illustrated dovetail-type locking structures. The rigid external shell 30 includes a plurality of the first releasable locking structures 40 forming an array of the locking structures that may be evenly spaced along an internal periphery 41 of the outer wall 32. Similarly,the flexible container 34 includes a plurality of the second releasable locking structures 44 forming an array of the locking structures that may be evenly spaced along an external periphery 45 of the sidewall 48. The first and second locking structures 40 and 44 are aligned in a plane that is perpendicular to a central axis A of the opening 36. The first and second locking structures 40 and 44 inhibit the flexible container 34 from completely collapsing so that the flexible container 34 can maintain a negative pressure without completely collapsing.

[0024] Referring to FIGS. 1-5, a method 100 of providing a negative pressure using the fluidreceiving container assembly 14 (FIG. 2) includes securing the flexible container 34 to the rigid external shell 30 using the first and second releasable locking structures 40 and 44, as discussed above, at step 102. At step 104, the suction pump 28 is connected to the flexible container 34 at a valve 60 using a connector 62 (FIG. 4A) and a conduit 64 (FIG. 1). The valve 60 may be configured to prevent air from entering the flexible container 34 to generate negative pressure when the valve 60 is closed. The drainage line 16 may be closed using a clamp device 66, such as a roller clamp while the flexible container 34 is being evacuated using the suction pump 28 at step 106. A pressure gauge 68 (FIG. 1) on the suction pump 28 can provide real-time feedback for when a predetermined negative pressure amount is reached at step 108. At step 110, once the flexible container 34 is evacuated, the suction pump 28 can be disconnected from the flexible container 34 and the valve 60 closed. At step 112, the drainage line 16 may be connected to the conduit 12, and drainage initiated be opening the clamp device 66 and / or by puncturing a foil seal between the flexible container 34 and the drainage line 16. At step 114, when the drainage operation is complete, the first and second locking structures 40 and 44 can disengage and the flexible container 34 can be removed from the external shell 40 and discarded.

[0025] The above-described fluid-receiving container assemblies may be suitable for drainage operations and include a reusable outer shell and a disposable flexible container that connects to the outer shell to maintain structure or volume to generate negative pressure in the flexible container. The flexible container can be disposed of after use and can be folded or crushed to take up less area in a landfill and also to take up less space to provide more flexible containers per case for shipping compared to pre-evacuated bottles.

[0026] Embodiments can be described with reference to the following numbered clauses, with certain features laid out in the dependent clauses:

[0027] Clause 1 : A fluid-receiving container assembly configured for use in collecting bodily fluid during a drainage procedure includes a reusable, relatively rigid external shell comprising an outer wall configured to extend around a disposable, relatively flexible container. The outer wall forms an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall. A disposable, relatively flexible container is located in the opening. The rigid external shell includes a first releasable locking structure located on an interior surface of the outer wall, and the flexible container comprises a second releasable locking structure located on an exterior surface of a sidewall of the flexible container that is configured to releasably mate with the first releasable locking structure. The second locking structure is engaged with the first locking structure.

[0028] Clause 2: The container assembly of clause 1, wherein the first locking structure and the second locking structure are configured to disengage as the flexible container is removed from the container holding volume.

[0029] Clause 3: The container assembly of clause 2, wherein the first locking structure comprises a bracket with a slot that extends parallel to a central axis of the opening.

[0030] Clause 4: The container assembly of clause 3, wherein the second locking structure comprises a locking tab that is sized and configured to be received within the slot in an engaged configuration.

[0031] Clause 5: The container assembly of any of clauses 1-4, wherein the first locking structure is one of a plurality of first locking structures that are located on the interior surface of the inner sidewall, spaced-apart around a perimeter of the container holding volume.

[0032] Clause 6: The container assembly of clause 5, wherein the first locking structures of the plurality of first locking structures are aligned in a plane that is perpendicular to a central axis of the opening.

[0033] Clause 7: The container assembly of clause 6, wherein the second locking structure is one of a plurality of second locking structures that are located on the exterior surface of the sidewall of the flexible container, wherein each of the plurality of second locking structures are arranged and positioned to engage each of the plurality of first locking structures.

[0034] Clause 8: The container assembly of claim 1, wherein the rigid external shell comprises a bottom wall located at an end of the outer wall and that spans the opening.

[0035] Clause 9: A reusable rigid external shell including an outer wall configured to extend around a disposable, flexible container. The outer wall forming an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall. The rigid external shell includes a plurality of first releasable locking structures located on an interior surface of the outer wall. The plurality of first releasable locking structures is configured to releasably mate with a plurality of second releasable locking structures located on an exterior surface of a sidewall of the flexible container.

[0036] Clause 10: The rigid external shell of clause 9 further comprising a bottom wall located at an end of the outer wall and that spans the opening.

[0037] Clause 11: The rigid external shell of clause 9 or 10, wherein the outer wall extends continuously about the opening.

[0038] Clause 12: The rigid external shell of any of clauses 9-11, wherein the first locking structures of the plurality of first locking structure are configured to disengage the second locking structures of the plurality of second locking structures as the flexible container is removed from the container holding volume.

[0039] Clause 13: The rigid external shell of claim 12, wherein the first locking structures of the plurality of first locking structures each comprise a bracket with a slot that extends parallel to a central axis of the opening.

[0040] Clause 14. The container assembly of any of clauses 9-13, wherein the first locking structures of the plurality of first locking structures are spaced apart around a perimeter of the container holding volume.

[0041] Clause 15: The rigid external shell of clause 14, wherein the first locking structures of the plurality of first locking structures are aligned in a plane that is perpendicular to a central axis of the opening.

[0042] Clause 16: A flexible container configured for use in collecting bodily fluid during a drainage procedure includes a sidewall formed of a flexible material. The sidewall forms a bodyhaving a fluid-receiving volume. A plurality of second releasable locking structures located on an exterior surface of the sidewall of the container. The plurality of second releasable locking structures is configured to releasably mate with a plurality of first releasable locking structures located on an interior surface of an outer wall of a reusable rigid external shell having a container holding volume that is surrounded by the outer wall.

[0043] Clause 17: The flexible container of clause 16, wherein the second locking structures of the plurality of second locking structures are configured to disengage the first locking structures of the plurality of first locking structures as the flexible container is removed from the container holding volume.

[0044] Clause 18: The flexible container of clause 16 or 17, wherein the plurality of second releasable locking structures lie in the same plane.

[0045] Clause 19: The flexible container of any of clauses 16-18, wherein the second locking structures of the plurality of second locking structures comprise a locking tab that is sized and configured to be received within a slot of the first locking structures of the plurality of first locking structures.

[0046] Clause 20: The flexible container of any of clauses 16-19, wherein the sidewall comprises a silicone, polyvinyl chloride or paper material.

[0047] It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments described herein without departing from the spirit and scope of the claimed subject matter. Thus it is intended that the specification cover the modifications and variations of the various embodiments described herein provided such modification and variations come within the scope of the appended claims and their equivalents.

Claims

CLAIMS1. A fluid-receiving container assembly configured for use in collecting bodily fluid during a drainage procedure, the container assembly comprising: a reusable, relatively rigid external shell comprising an outer wall configured to extend around a disposable, relatively flexible container, the outer wall forming an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall; and a disposable, relatively flexible container located in the opening; wherein the rigid external shell comprises a first releasable locking structure located on an interior surface of the outer wall and the flexible container comprises a second releasable locking structure located on an exterior surface of a sidewall of the flexible container that is configured to releasably mate with the first releasable locking structure, the second locking structure being engaged with the first locking structure.

2. The container assembly of claim 1, wherein the first locking structure and the second locking structure are configured to disengage as the flexible container is removed from the container holding volume.

3. The container assembly of claim 2, wherein the first locking structure comprises a bracket with a slot that extends parallel to a central axis of the opening.

4. The container assembly of claim 3, wherein the second locking structure comprises a locking tab that is sized and configured to be received within the slot in an engaged configuration.

5. The container assembly of claim 1, wherein the first locking structure is one of a plurality of first locking structures that are located on the interior surface of the inner sidewall, spaced apart around a perimeter of the container holding volume.

6. The container assembly of claim 5, wherein the first locking structures of the plurality of first locking structures are aligned in a plane that is perpendicular to a central axis of the opening.

7. The container assembly of claim 6, wherein the second locking structure is one of a plurality of second locking structures that are located on the exterior surface of the sidewall of the flexible container, wherein each of the plurality of second locking structures are arranged and positioned to engage each of the plurality of first locking structures.

8. The container assembly of claim 1, wherein the rigid external shell comprises a bottom wall located at an end of the outer wall and that spans the opening.

9. A reusable rigid external shell comprising: an outer wall configured to extend around a disposable, flexible container, the outer wall forming an opening that is sized and configured to receive the flexible container within a container holding volume surrounded by the outer wall; wherein the rigid external shell comprises a plurality of first releasable locking structures located on an interior surface of the outer wall; wherein the plurality of first releasable locking structures is configured to releasably mate with a plurality of second releasable locking structures located on an exterior surface of a sidewall of the flexible container.

10. The rigid external shell of claim 9 further comprising a bottom wall located at an end of the outer wall and that covers the opening.

11. The rigid external shell of claim 9, wherein the outer wall extends continuously about the opening.

12. The rigid external shell of claim 9, wherein the first locking structures of the plurality of first locking structures are configured to disengage the second locking structures of the plurality of second locking structures as the flexible container is removed from the container holding volume.

13. The rigid external shell of claim 12, wherein the first locking structures of the plurality of first locking structures each comprise a bracket with a slot that extends parallel to a central axis of the opening.

14. The container assembly of claim 9, wherein the first locking structures of the plurality of first locking structures are spaced apart around a perimeter of the container holding volume.

15. The rigid external shell of claim 14, wherein the first locking structures of the plurality of first locking structures are aligned in a plane that is perpendicular to a central axis of the opening.

16. A flexible container configured for use in collecting bodily fluid during a drainage procedure, the flexible container comprising: a sidewall formed of a flexible material, the sidewall forming a body having a fluidreceiving volume; and a plurality of second releasable locking structures located on an exterior surface of the sidewall of the container; wherein the plurality of second releasable locking structures is configured to releasably mate with a plurality of first releasable locking structures located on an interior surface of an outer wall of a reusable rigid external shell having a container holding volume that is surrounded by the outer wall.

17. The flexible container of claim 16, wherein the second locking structures of the plurality of second releasable locking structures are configured to disengage the first locking structures of the plurality of first locking structures as the flexible container is removed from the container holding volume.

18. The flexible container of claim 16, wherein the plurality of second releasable locking structures lie in a plane.

19. The flexible container of claim 16, wherein the second releasable locking structures of the plurality of second releasable locking structures comprise a locking tab that is sized and configured to be received within a slot of the first locking structures of the plurality of first locking structures.

20. The flexible container of claim 16, wherein the sidewall comprises a silicone, polyvinyl chloride material or paper material.

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