The present specification generally relates to drainage systems and methods for draining bodily fluid and, more specifically, to drainage systems and methods including a displacement body for introducing a negative pressure for draining and collecting bodily fluids.
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. The turnover of fluid in the pleural space is normally quite rapid—roughly 35 to 75% of the total fluid per hour, so that 5 to 10 L of fluid moves through the pleural space each day. 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.
Peritoneal effusion or ascites refers to an excess collection of fluid in the abdominal cavity, such as more than 25 mL of fluid. The most common cause of such excess fluid collection is liver cirrhosis and other causes include cancer and pancreatitis.
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, hidden under a bandage when not in use. 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.
According to a first embodiment, a drainage system for draining bodily fluid includes a fluid-receiving container having a fluid-receiving volume located therein that is configured to receive a bodily fluid. The fluid-receiving container includes an inlet and a drainage conduit communicatively coupled to the inlet of the fluid-receiving container. The drainage conduit is communicatively coupled to a connector that connects to a drainage catheter. A first one-way valve is along the drainage conduit that provides a one-way fluid flow direction through the drainage conduit into the fluid-receiving volume. A displacement body is out-of-line with the drainage conduit and fluidly connected to the drainage conduit. The displacement body is configured to be actuated and released to provide a negative pressure to a fluid-receiving passageway through the drainage conduit. The first one-way valve inhibits air from being drawn from the fluid-receiving volume of the fluid-receiving container due to the negative pressure. A second one-way valve is along the fluid-receiving passageway at a location between the displacement body and the connector that inhibits fluids from passing in a direction toward the connector. Actuation of the displacement body displaces air within the fluid-receiving passageway, the air being forced into the fluid-receiving volume by the second one-way valve and inhibited from escaping the fluid-receiving volume by the first one-way valve.
According to a second embodiment, a method of forming a drainage system for draining a bodily fluid from a body cavity is provided. The method includes fluidly connecting an outlet end of an drainage conduit to an inlet of a fluid-receiving container and fluidly connecting a first one-way valve to the drainage conduit. The one-way valve provides a one-way fluid flow direction through the drainage conduit into a fluid-receiving volume of the fluid-receiving container. A displacement body is fluidly connected to the drainage conduit in an out-of-line fashion. A connector is fluidly connected to an inlet end of the drainage conduit, the connector configured to connect to a drainage catheter. The displacement body is configured to be actuated manually to provide a negative pressure to a fluid-receiving passageway through the drainage conduit, the one-way valve inhibiting air from being drawn from the fluid-receiving volume of the fluid-receiving container due to the negative pressure.
According to a third embodiment, a drainage system for draining bodily fluid includes a fluid-receiving container having a fluid-receiving volume located therein that is configured to receive a bodily fluid, the fluid-receiving container comprising an inlet. A drainage conduit is communicatively coupled to the inlet of the fluid-receiving container. The drainage conduit is communicatively coupled to a connector that connects to a drainage catheter. A first one-way valve provides a one-way fluid flow direction through the drainage line and into the fluid-receiving volume. A displacement body is out-of-line with the drainage conduit and fluidly connected to the drainage conduit. The displacement body is configured to be actuated and released to provide a negative pressure to a fluid-receiving passageway through the drainage conduit. The displacement body is located between the first one-way valve and a second one-way valve. Compressing the displacement body displaces air within the displacement body. The second one-way valve prevents air from entering the displacement body. The first one-way valve allows a negative pressure to be communicated from the displacement body, through the drainage conduit and to the connector.
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.
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:
Embodiments described herein are generally directed to drainage systems for draining bodily fluids. The drainage systems include a fluid-receiving container having a fluid-receiving volume that receives a bodily fluid therein through an inlet. The fluid-receiving container is in fluid communication with a drainage conduit connected to the fluid-receiving container at the inlet. The drainage conduit is fluidly connected to a connector that connects to a drainage catheter. A displacement body is fluidly connected to the drainage conduit by a connecting conduit such that the displacement body is out-of-line with the drainage conduit. The displacement body is configured to be actuated and released to provide a negative pressure to a fluid-receiving passageway through the drainage conduit. A one-way valve is located along the drainage conduit downstream of the connecting conduit. The one-way valve inhibits air from being drawn from the fluid-receiving volume of the fluid-receiving container due to the negative pressure. Another one-way valve is located along the drainage conduit at a location between the connecting conduit and the connector that inhibits fluids from passing in a direction toward the connector. Actuation of the displacement body displaces air within the fluid-receiving passageway, the air being forced into the fluid-receiving volume by the another one-way valve and inhibited from escaping the fluid-receiving volume by the one-way valve downstream of the connecting catheter.
Referring to
A displacement body 28 includes a squeeze bulb 31 that is used to supply negative pressure through the drainage conduit 16 and the drainage catheter 12. The negative pressure provides a suction to automatically draw bodily fluid from the cavity in which the drainage catheter 12 is inserted toward the fluid-receiving container 14. As used herein, the terms “negative pressure,” “suction,” vacuum” and “partial vacuum” may be used interchangeably and refer to a force over an area produced by a difference in pressure. Pressure may be referred to as “negative” in reference to atmospheric pressure (i.e., gauge pressure). It should be noted that while using the displacement body for draining bodily fluids from body cavities is described primarily herein, the displacement bodies may be used to drain bodily fluids from other locations, such as wounds.
The displacement body 28 includes a resiliently flexible outer wall 30 that forms a bulb-shape having an internal volume that is filled with a gas, such as air. The flexible outer wall 30 can be formed of any suitable compliant material, such as silicone. The flexible outer wall 30 can be constricted (e.g., squeezed) and, when released, used to generate the negative pressure differential relative to pressure within the body cavity to initiate fluid drainage from the body cavity. The displacement body 28 is fluidly connected to a connecting conduit 32 that is fluidly connected to the drainage conduit 16. In some embodiments, the drainage conduit 16 and the connecting conduit 32 may be part of a same T or Y-shaped tubing. In other embodiments, a connection, such as a T or Y-shaped connector may be used to fluidly connect the drainage conduit 16 and the connecting conduit 32. A flow blocking member 36, such as a filter (e.g., hydrophobic or hydrophilic) or one-way valve may be located in the connecting conduit 32 between the displacement body 28 and the drainage conduit 16. The flow blocking member 36 can allow the gas (air) to pass therethrough and through the connecting conduit 32, at least until being wetted by bodily fluid, and block drainage fluid from passing therethrough and entering the displacement body 28 during a drainage operation. In this regard, the displacement body 28 may be considered “out-of-line” with or branched-off from the drainage conduit 16 as bodily fluid does not pass through the displacement body 28 on its way to the fluid-receiving container 14. The displacement body 28 is not fluidly connected directly to the drainage conduit 16 and fluid is blocked from the displacement body 28 and does not pass through the displacement body 28.
A one-way valve 40 is located along the drainage conduit 16 downstream of the displacement body 28. The terms “downstream” and “upstream” are with reference to drainage flow during a drainage operation with a downstream direction being toward the fluid-receiving container 14 and upstream direction being away from the fluid-receiving container. In the illustrated example, the one-way valve 40 is a flutter valve that is located at an inlet 42 to a fluid-receiving volume 44 of the fluid-receiving container 14. An end 46 of the drainage conduit 16 may be fluidly connected to the one way valve 40 at the inlet 42. In some embodiments, the end 46 may be connected to a stub tube. While the one-way valve 40 is located at the inlet 42, a one way valve may be located anywhere along the drainage conduit 16 between the fluid-receiving volume 44 and the connecting conduit 32. For example, it may be desirable to provide the one way valve 40 closer to the connecting conduit 32 to reduce a distance between the connector 18 and the one-way valve 40 thereby reducing an air-filled volume in the drainage conduit 16 when providing negative pressure, as will be described in greater detail below.
Another one-way valve 50 is located along the drainage conduit 16 upstream of the connecting conduit 32. The one-way valve 50 may be located anywhere along the drainage conduit 16 between the displacement body 28 and the connector 18. During a drainage operation, the one-way valve 50 prevents the flow of fluids (i.e., gases and liquids) upstream toward the body cavity. Further, a flow control device 35 may be used to constrict or release the drainage conduit 16, which can be used to decrease or increase fluid flow rate as desired by the user.
Referring also to
In some instances, it may be desirable to introduce a lower pressure within the fluid-receiving passageway 17 of the drainage catheter 12 to initiate or increase bodily fluid flow. To this end, the displacement body 28 may be manually squeezed thereby reducing its internal volume and forcing air out of the displacement body 28, through the flow blocking member 36 and into the fluid-receiving passageway 17 at step 60 (
At step 62, the displacement body 28 is manually released (
At step 64, some of the bodily fluid may travel toward the displacement body 28 along the connecting conduit 32 (
While
A one-way valve 84 is located along the connecting conduit 76 at the inlet 74 between the displacement body 72 and the flow blocking member 82. Another one-way valve 86 is located at an outlet 88 of the displacement body 72, between the displacement body 72 and the environment. In operation, manually constricting the displacement body 72 reduces the volume inside the displacement body 72. As the volume decreases, the one-way valve 84 prevents the air, represented by arrow 90, from passing therethrough and through the connecting conduit 76. The one-way valve 86 allows air, represented by arrow 92, to escape from the volume of the displacement body 72 and into the surroundings.
Referring now to
The above-described drainage systems may be suitable for pleural and peritoncal drainage operations and include a displacement body that can be used to enhance flow of bodily fluid from a body cavity and into a fluid-receiving container, such as a bag formed of a clear plastic film that has printed volume markings. Once the drainage conduit is attached to the drainage catheter, fluid may begin to flow without assistance from the displacement body, which is considered gravity drainage. When the displacement body is compressed manually, the displacement body pushes air out of its volume. The air may be pushed into the fluid-receiving container or into the surroundings depending on the configuration of the system. In either case, the displacement body provides a suction to the fluid-receiving passageway that passes through the drainage conduit. A flow control device may be provided that allows for manual control of the drainage rate, which can improve patient comfort during the drainage operation.
Embodiments can be described with reference to the following numbered clauses, with certain features laid out in the dependent clauses:
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.
Filing Document | Filing Date | Country | Kind |
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PCT/US21/62633 | 12/9/2021 | WO |