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WO2024172840A1 - Drainage systems including biased displacement pump for providing a negative pressure for draining and collecting bodily fluids - Google Patents

Drainage systems including biased displacement pump for providing a negative pressure for draining and collecting bodily fluids Download PDF

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Publication number
WO2024172840A1
WO2024172840A1 PCT/US2023/062644 US2023062644W WO2024172840A1 WO 2024172840 A1 WO2024172840 A1 WO 2024172840A1 US 2023062644 W US2023062644 W US 2023062644W WO 2024172840 A1 WO2024172840 A1 WO 2024172840A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
piston
drainage
volume
displacement pump
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2023/062644
Other languages
French (fr)
Inventor
Erin L. Schaus
Katherine DONIEC
Amy A. MASON
Michael Plishka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bard Peripheral Vascular Inc
Original Assignee
Bard Peripheral Vascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bard Peripheral Vascular Inc filed Critical Bard Peripheral Vascular Inc
Priority to PCT/US2023/062644 priority Critical patent/WO2024172840A1/en
Publication of WO2024172840A1 publication Critical patent/WO2024172840A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80Suction pumps
    • A61M1/81Piston pumps, e.g. syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/60Containers for suction drainage, adapted to be used with an external suction source
    • A61M1/63Containers for suction drainage, adapted to be used with an external suction source with means for emptying the suction container, e.g. by interrupting suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/74Suction control
    • A61M1/741Suction control with means for varying suction manually
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/60Containers for suction drainage, adapted to be used with an external suction source
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/74Suction control
    • A61M1/741Suction control with means for varying suction manually
    • A61M1/7413Suction control with means for varying suction manually by changing the cross-section of the line
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/07General characteristics of the apparatus having air pumping means
    • A61M2205/071General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/073Syringe, piston type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/101Pleural cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1017Peritoneal cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston

Definitions

  • the present specification generally relates to drainage systems and methods for draining bodily fluid and, more specifically, to drainage systems and methods including a biased displacement pump 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.
  • 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.
  • a drainage system for draining bodily fluid includes a fluid-receiving body having a fluid-receiving volume located therein that is configured to receive a bodily fluid.
  • the fluid-receiving body includes an inlet.
  • a drainage conduit is communicatively coupled to the inlet of the fluid-receiving body.
  • the drainage conduit is communicatively coupled to a connector that connects to a drainage catheter.
  • a displacement pump is fluidly connected to the drainage conduit.
  • the displacement pump includes a barrel including an outer wall and having a fixed internal volume.
  • a piston is sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber.
  • a spring is engaged with the barrel and the piston within the fixed internal volume.
  • the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume.
  • a release member is connected to the piston through the barrel that moves relative to the outer wall.
  • the release member has an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit.
  • a method of forming a drainage system for draining a bodily fluid from a body cavity includes fluidly connecting an outlet end of a drainage conduit to an inlet of a fluid-receiving body.
  • a displacement pump is fluidly connected to the drainage conduit.
  • the displacement pump includes a barrel including an outer wall and having a fixed internal volume.
  • a piston is sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber.
  • a spring is engaged with the barrel and the piston within the fixed internal volume. The spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume.
  • a release member is connected to the piston through the barrel that moves relative to the outer wall.
  • the release member has an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit.
  • a connector is fluidly connected to an inlet end of the drainage conduit. The connector is configured to connect to a drainage catheter.
  • FIG. 1 schematically depicts a drainage system including a displacement pump, according to one or more embodiments shown and described herein;
  • FIG. 2 schematically depicts the displacement pump of FIG. 1 in a collapsed configuration, according to one or more embodiments shown and described herein;
  • FIG. 3 schematically depicts the displacement pump of FIG. 1 in an expanded configuration, according to one or more embodiments shown and described herein;
  • FIG. 4A schematically depicts the drainage system of FIG. 1 in operation, according to one or more embodiments shown and described herein;
  • FIG. 4B schematically depicts the drainage system of FIG. 1 in operation, according to one or more embodiments shown and described herein;
  • FIG. 4C schematically depicts the drainage system of FIG. 1 in operation, according to one or more embodiments shown and described herein.
  • 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 pump is fluidly connected to the drainage conduit.
  • the displacement pump includes a barrel including an outer wall and has a fixed internal volume.
  • a piston is sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber.
  • a spring is engaged with the barrel and the piston within the fixed internal volume.
  • the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume.
  • a release member is connected to the piston through the barrel that moves relative to the outer wall.
  • the release member has an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit.
  • a drainage system 10 for use in draining bodily fluids from body cavities includes a drainage catheter 12 that may be partially implanted in a patient’s body and a fluid-receiving container 14 that can be fluidly connected to the drainage catheter 12.
  • the fluidreceiving container 14 may be connected to the drainage catheter 12 by a drainage conduit 16 that extends from the fluid-receiving container 14 to the drainage catheter 12 providing a fluidreceiving passageway 17 therebetween.
  • the drainage conduit 16 may include a connector 18 that connects to a valve 20.
  • the valve 20 may be a two- piece valve that is normally closed, but that opens with insertion of the connector 18 to allow bodily fluid to flow through the drainage conduit 16.
  • a distal end portion 22 of the drainage catheter 12 may be implanted in the patient’s body for pleural or peritoneal drainage or other body location for draining a bodily fluid.
  • the distal end portion 22 may include a sealing cuff 24 and fenestrations 26 through which the bodily fluid may enter the drainage catheter 12 and be carried from the pleural, peritoneal or other cavity space.
  • a displacement pump 28 is used to supply negative pressure through the drainage conduit 16 and the drainage catheter 12.
  • the negative pressure provides a suction to draw bodily fluid from the cavity in which the drainage catheter 12 is inserted toward the fluid-receiving container 14.
  • 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 pump 28 for draining bodily fluids from body cavities is described primarily herein, the displacement pump 28 may be used to drain bodily fluids from other locations, such as wounds.
  • the displacement pump 28 includes a barrel 30 including an outer wall 32 and has a fixed internal volume 34.
  • a piston 36 is sealingly engaged with the outer wall within the fixed internal volume 34 (e.g., using an O-ring seal) thereby dividing the fixed internal volume 34 and providing a pump chamber 38.
  • a spring 40 is engaged with the barrel 30 and the piston 36 within the pump chamber 38. The spring 40 biases the piston 36 away from an initial, collapsed position of decreased pump chamber 38 volume (FIG. 2) to an expanded position of increased pump chamber 38 volume (FIG. 3).
  • a release member 42 is connected to the piston 36 using a piston rod 43 that extends through the barrel 30 that moves relative to the outer wall 32.
  • the release member 42 has an initial, locked position interlocked with a lock structure 44 to prevent movement of the piston 36 from the collapsed position and a release position disengaged with the lock structure 44.
  • the piston 36 In the release position, the piston 36 is free to move toward the expanded position due to a spring force provided by the spring 40 increasing the volume in the pump chamber 38 and providing a negative pressure to the drainage conduit 16.
  • the displacement pump 28 is fluidly connected to a connecting tube 46 that is fluidly connected to the drainage conduit 16.
  • the drainage conduit 16 and the connecting tube 46 may be part of a same T or Y-shaped tubing.
  • a connection such as a T or Y-shaped connector 47 may be used to fluidly connect the drainage conduit 16 and the connecting tube 46.
  • a flow blocking member 48 such as a filter (e.g., hydrophobic or hydrophilic) or one-way valve may be located in the connecting tube 46 between the displacement pump 28 and the drainage conduit 16.
  • the flow blocking member 48 can allow the gas (air) to pass therethrough and through the connecting tube 46, at least until being wetted by bodily fluid, and block drainage fluid from passing therethrough and entering the displacement pump 28 during a drainage operation.
  • the displacement pump 28 may be considered “out-of-line” with or branched-off from the drainage conduit 16 as bodily fluid may not pass through the displacement pump 28 on its way to the fluid-receiving container 14.
  • the displacement pump 28 may not be fluidly connected directly to the drainage conduit 16 and fluid may be blocked from the displacement pump 28 and may not pass through the displacement pump 28.
  • a one-way valve 50 may be located along the drainage conduit 16 downstream of the displacement pump 28.
  • the one-way valve 50 is a flutter valve that is located at an inlet 52 to a fluidreceiving volume 54 of the fluid-receiving container 14.
  • An end 56 of the drainage conduit 16 may be fluidly connected to the one-way valve 50 at the inlet 52.
  • the end 56 may be connected to a stub tube.
  • a oneway valve may be located anywhere along the drainage conduit 16 between the fluid-receiving volume 54 and the connecting tube 46. For example, it may be desirable to provide the one-way valve 50 closer to the connecting tube 46 to reduce a distance between the connector 18 and the one-way valve 50 thereby reducing an air-filled volume in the drainage conduit 16 when providing negative pressure.
  • Another one-way valve 60 may optionally be located along the drainage conduit 16 upstream of the connecting tube 46.
  • the one-way valve 60 may be located anywhere along the drainage conduit 16 between the displacement pump 28 and the connector 18.
  • the one-way valve 60 prevents the flow of fluids (i.e., gases and liquids) upstream toward the body cavity.
  • the one-way valve 60 may not be used.
  • a flow control device 62 e.g., a tubing clamp
  • a drainage operation may be initiated with the drainage catheter 12 already implanted within a body cavity represented by element C.
  • the fluid-receiving container 14 e.g., a bag
  • the drainage conduit 16 may be placed on a floor such that it is lower than the body cavity C.
  • drainage flow may begin or continue without actuation of the displacement pump 28 (FIG. 4A). This is considered gravity flow.
  • the displacement pump 28 includes the release member 42 that is connected to the piston 36 through the barrel 30 and moves relative to the outer wall 32.
  • the release member 42 may be, for example, a switch that can be rotated relative to or along with the piston shaft 43 between the initial, locked position interlocked with the lock structure 44 to prevent movement of the piston 36 from the collapsed position and the release position disengaged with the lock structure 44.
  • the piston 36 In the release position, the piston 36 is free to move toward the expanded position due to the spring force provided by the spring 40 thereby providing a negative pressure to the drainage conduit 16.
  • the lock structure 44 comprises a notch 68 that is formed in the outer wall 32 of the barrel 30.
  • the release member 42 includes a catch projection 70 that engages the outer wall 32 at the notch 68 in the locked position.
  • the notch 68 may be formed by the outer wall 32 having an overhang portion 71 and a release opening 73 (FIG. 3).
  • the overhang portion 71 can extend over the catch projection 70 with the catch projection 70 received within the notch 68.
  • the notch 68 may be open at one end to allow the catch projection 70 to move out of the notch 68 into the release opening 73 thereby releasing the piston 36.
  • Other suitable lock structures and release members may be used, such as tabs, latches, buttons, etc.
  • the displacement pump 28 may be provided to a user with the release member 42 in the locked position.
  • a movement inhibiting structure such as a tear tab, plastic wrap, etc. may be placed on and/or around the release member 42 to inhibit unintended movement of the release member 42 and unintended operation of the displacement pump 28.
  • the release member 42 may be manually rotated (FIG. 4B) by twisting the release member 42 relative to the outer wall 32 from the locked position to the release position. With the release member 42 in the release position, the catch projection 70 is moved out of the notch and clear of the overhang portion 71. Once the catch projection 70 is aligned with the release opening 70, the release member 42, piston rod 43 and piston 46 are free to move relative to the barrel 30 by the spring 40 to the expanded position of increased pump chamber 38 volume, as represented by arrow 75 of FIG. 4C. The pump chamber 38 expands in volume thereby creating a suction that is communicated through the connecting tube 46 and to the fluid-receiving passageway 17.
  • the one-way valve 50 prevents the air from being drawn from the fluid-receiving volume 54 and back into the displacement pump 28.
  • the other one-way valve 60 allows the negative pressure to be communicated therethrough to the drainage catheter 12.
  • some of the bodily fluid may travel toward the displacement pump 28 along the connecting tube 46 (FIG. 4C).
  • the flow blocking member 48 may prevent the flow of liquid into the displacement pump 28.
  • the drainage of the bodily fluid may occur under the influence of gravity without negative pressure being introduced to the fluid-receiving passageway 17 by the displacement pump 28.
  • the flow control device 62 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.
  • the fluid-receiving container 14 may be formed of a plastic sheet material that includes a line of weakness 104 that facilitates tearing of the fluid-receiving container 14 and pouring out of the contents.
  • the above-described drainage systems may be suitable for pleural and peritoneal drainage operations and include a displacement pump 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.
  • a displacement pump 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.
  • a drainage system for draining bodily fluid comprising: a fluid-receiving body having a fluid-receiving volume located therein that is configured to receive a bodily fluid, the fluid-receiving body comprising an inlet; a drainage conduit communicatively coupled to the inlet of the fluid-receiving body, the drainage conduit being communicatively coupled to a connector that connects to a drainage catheter; and a displacement pump fluidly connected to the drainage conduit, the displacement pump comprising: a barrel including an outer wall and having a fixed internal volume; a piston sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber; a spring engaged with the barrel and the piston within the fixed internal volume; wherein the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume; and a release member connected to the piston through the barrel that moves relative to the outer wall, the release member having an initial
  • Clause 2 The drainage system of clause 1, wherein the lock structure comprises a notch that is formed in the outer wall, the release member is configured to rotate out of the notch as the lock structure rotates from the locked position to the release position.
  • Clause 3 The drainage system of clause 2, wherein the release member includes a catch that is received by the notch.
  • Clause 4 The drainage system of any of clauses 1-3, wherein the release member is connected to the piston by a piston rod that extends through the internal volume of the barrel.
  • Clause 5 The drainage system of any of clauses 1-4, wherein the displacement pump is out-of-line with the drainage conduit.
  • Clause 6 The drainage system of any of clauses 1-5 further comprising a one-way valve at the inlet of the fluid-receiving body that provides a one-way fluid flow direction through the inlet and into the fluid-receiving volume, the one-way valve at the inlet inhibiting air from being drawn from the fluid-receiving volume of the fluid-receiving body due to the negative pressure.
  • Clause 7 The drainage system of clause 6 further comprising another one-way valve along a fluid-receiving passageway at a location between the displacement pump and the connector that inhibits fluids from passing in a direction toward the connector.
  • Clause 8 The drainage system of clause 7 further comprising a flow control device located along the drainage conduit.
  • Clause 9 The drainage system of clause 8, wherein the flow control device is located between the another one-way valve and the connector.
  • Clause 10 The drainage system of any of clauses 1-9, wherein the release member moves with the piston relative to the sidewall.
  • Clause 11 The drainage system of any of clauses 1-10, wherein the fluid-receiving body is a bag comprising a line of weakness that facilitates tearing the bag.
  • a method of forming a drainage system for draining a bodily fluid from a body cavity comprising: fluidly connecting an outlet end of a drainage conduit to an inlet of a fluid-receiving body; fluidly connecting a displacement pump to the drainage conduit, the displacement pump comprising: a barrel including an outer wall and having a fixed internal volume; a piston sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber; a spring engaged with the barrel and the piston within the fixed internal volume; wherein the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume; and a release member connected to the piston through the barrel that moves relative to the outer wall, the release member having an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing
  • Clause 13 The method of clause 12, wherein the lock structure comprises a notch that is in the outer wall, the release member is configured to rotate out of the notch as the lock structure rotates from the locked position to the release position.
  • Clause 14 The method of clause 13, wherein the release member includes a catch that is received by the notch.
  • Clause 15 The method of any of clauses 12-14, wherein the release member is connected to the piston by a piston rod that extends through the internal volume of the barrel.
  • Clause 16 The method of any of clauses 12-15, wherein the displacement pump is out- of-line with the drainage conduit.
  • Clause 17 The method of any of clauses 12-16 further comprising fluidly connecting a one-way valve within a fluid-receiving volume of the fluid-receiving body to the outlet end of the drainage conduit, the one-way valve providing a one-way fluid flow direction through the inlet.
  • Clause 18 The method of clause 17, wherein the one-way valve is at the inlet and inhibiting air from being drawn from the fluid-receiving volume of the fluid-receiving body due to the negative pressure
  • Clause 19 The method of any of clauses 12-18 further comprising placing another oneway valve along a fluid-receiving passageway at a location between the displacement pump and the connector that inhibits fluids from passing in a direction toward the connector.
  • Clause 20 The method of clause 19 further comprising placing a flow control device along the drainage conduit that adjusts a diameter of the fluid-receiving passageway.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

A drainage system for draining bodily fluid includes a fluid-receiving body having a fluid-receiving volume located therein that is configured to receive a bodily fluid. The fluid-receiving body includes an inlet. A drainage conduit is communicatively coupled to the inlet of the fluid-receiving body. The drainage conduit is communicatively coupled to a connector that connects to a drainage catheter. A displacement pump is fluidly connected to the drainage conduit. The displacement pump includes a barrel including an outer wall and having a fixed internal volume. A piston is sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber. A spring is engaged with the barrel and the piston within the fixed internal volume. The spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume.

Description

DRAINAGE SYSTEMS INCLUDING BIASED DISPLACEMENT PUMP FOR PROVIDING A NEGATIVE PRESSURE FOR DRAINING AND COLLECTING BODILY FLUIDS
TECHNICAL FIELD
[0001] The present specification generally relates to drainage systems and methods for draining bodily fluid and, more specifically, to drainage systems and methods including a biased displacement pump for introducing a negative pressure 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. The turnover of fluid in the pleural space is normally quite rapid - roughly 35 to 75% of the total fluid per hour. 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, 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.
[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, 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. A need exists for other drainage systems without pre-evacuated bottles. SUMMARY
[0005] According to a first embodiment, a drainage system for draining bodily fluid includes a fluid-receiving body having a fluid-receiving volume located therein that is configured to receive a bodily fluid. The fluid-receiving body includes an inlet. A drainage conduit is communicatively coupled to the inlet of the fluid-receiving body. The drainage conduit is communicatively coupled to a connector that connects to a drainage catheter. A displacement pump is fluidly connected to the drainage conduit. The displacement pump includes a barrel including an outer wall and having a fixed internal volume. A piston is sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber. A spring is engaged with the barrel and the piston within the fixed internal volume. The spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume. A release member is connected to the piston through the barrel that moves relative to the outer wall. The release member has an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit.
[0006] According to another 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 a drainage conduit to an inlet of a fluid-receiving body. A displacement pump is fluidly connected to the drainage conduit. The displacement pump includes a barrel including an outer wall and having a fixed internal volume. A piston is sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber. A spring is engaged with the barrel and the piston within the fixed internal volume. The spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume. A release member is connected to the piston through the barrel that moves relative to the outer wall. The release member has an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit. A connector is fluidly connected to an inlet end of the drainage conduit. The connector is configured to connect to a drainage catheter.
[0007] 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
[0008] 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:
[0009] FIG. 1 schematically depicts a drainage system including a displacement pump, according to one or more embodiments shown and described herein;
[0010] FIG. 2 schematically depicts the displacement pump of FIG. 1 in a collapsed configuration, according to one or more embodiments shown and described herein;
[0011] FIG. 3 schematically depicts the displacement pump of FIG. 1 in an expanded configuration, according to one or more embodiments shown and described herein;
[0012] FIG. 4A schematically depicts the drainage system of FIG. 1 in operation, according to one or more embodiments shown and described herein;
[0013] FIG. 4B schematically depicts the drainage system of FIG. 1 in operation, according to one or more embodiments shown and described herein; and
[0014] FIG. 4C schematically depicts the drainage system of FIG. 1 in operation, according to one or more embodiments shown and described herein.
DETAILED DESCRIPTION
[0015] 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 pump is fluidly connected to the drainage conduit. The displacement pump includes a barrel including an outer wall and has a fixed internal volume. A piston is sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber. A spring is engaged with the barrel and the piston within the fixed internal volume. The spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume. A release member is connected to the piston through the barrel that moves relative to the outer wall. The release member has an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit.
[0016] Referring to FIG. 1, a drainage system 10 for use in draining bodily fluids from body cavities includes a drainage catheter 12 that may be partially implanted in a patient’s body and a fluid-receiving container 14 that can be fluidly connected to the drainage catheter 12. The fluidreceiving container 14 may be connected to the drainage catheter 12 by a drainage conduit 16 that extends from the fluid-receiving container 14 to the drainage catheter 12 providing a fluidreceiving passageway 17 therebetween. In some embodiments, the drainage conduit 16 may include a connector 18 that connects to a valve 20. As an example, the valve 20 may be a two- piece valve that is normally closed, but that opens with insertion of the connector 18 to allow bodily fluid to flow through the drainage conduit 16. A distal end portion 22 of the drainage catheter 12 may be implanted in the patient’s 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 sealing cuff 24 and fenestrations 26 through which the bodily fluid may enter the drainage catheter 12 and be carried from the pleural, peritoneal or other cavity space.
[0017] A displacement pump 28 is used to supply negative pressure through the drainage conduit 16 and the drainage catheter 12. The negative pressure provides a suction to 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 pump 28 for draining bodily fluids from body cavities is described primarily herein, the displacement pump 28 may be used to drain bodily fluids from other locations, such as wounds.
[0018] Referring to FIGS. 2 and 3, the displacement pump 28 includes a barrel 30 including an outer wall 32 and has a fixed internal volume 34. A piston 36 is sealingly engaged with the outer wall within the fixed internal volume 34 (e.g., using an O-ring seal) thereby dividing the fixed internal volume 34 and providing a pump chamber 38. A spring 40 is engaged with the barrel 30 and the piston 36 within the pump chamber 38. The spring 40 biases the piston 36 away from an initial, collapsed position of decreased pump chamber 38 volume (FIG. 2) to an expanded position of increased pump chamber 38 volume (FIG. 3). A release member 42 is connected to the piston 36 using a piston rod 43 that extends through the barrel 30 that moves relative to the outer wall 32. The release member 42 has an initial, locked position interlocked with a lock structure 44 to prevent movement of the piston 36 from the collapsed position and a release position disengaged with the lock structure 44. In the release position, the piston 36 is free to move toward the expanded position due to a spring force provided by the spring 40 increasing the volume in the pump chamber 38 and providing a negative pressure to the drainage conduit 16.
[0019] Referring again to FIG. 1 , the displacement pump 28 is fluidly connected to a connecting tube 46 that is fluidly connected to the drainage conduit 16. In some embodiments, the drainage conduit 16 and the connecting tube 46 may be part of a same T or Y-shaped tubing. In other embodiments, a connection, such as a T or Y-shaped connector 47 may be used to fluidly connect the drainage conduit 16 and the connecting tube 46. A flow blocking member 48, such as a filter (e.g., hydrophobic or hydrophilic) or one-way valve may be located in the connecting tube 46 between the displacement pump 28 and the drainage conduit 16. The flow blocking member 48 can allow the gas (air) to pass therethrough and through the connecting tube 46, at least until being wetted by bodily fluid, and block drainage fluid from passing therethrough and entering the displacement pump 28 during a drainage operation. In this regard, the displacement pump 28 may be considered “out-of-line” with or branched-off from the drainage conduit 16 as bodily fluid may not pass through the displacement pump 28 on its way to the fluid-receiving container 14. The displacement pump 28 may not be fluidly connected directly to the drainage conduit 16 and fluid may be blocked from the displacement pump 28 and may not pass through the displacement pump 28. [0020] A one-way valve 50 may be located along the drainage conduit 16 downstream of the displacement pump 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 14. In the illustrated example, the one-way valve 50 is a flutter valve that is located at an inlet 52 to a fluidreceiving volume 54 of the fluid-receiving container 14. An end 56 of the drainage conduit 16 may be fluidly connected to the one-way valve 50 at the inlet 52. In some embodiments, the end 56 may be connected to a stub tube. While the one-way valve 50 is located at the inlet 52, a oneway valve may be located anywhere along the drainage conduit 16 between the fluid-receiving volume 54 and the connecting tube 46. For example, it may be desirable to provide the one-way valve 50 closer to the connecting tube 46 to reduce a distance between the connector 18 and the one-way valve 50 thereby reducing an air-filled volume in the drainage conduit 16 when providing negative pressure.
[0021] Another one-way valve 60 may optionally be located along the drainage conduit 16 upstream of the connecting tube 46. The one-way valve 60 may be located anywhere along the drainage conduit 16 between the displacement pump 28 and the connector 18. During a drainage operation, the one-way valve 60 prevents the flow of fluids (i.e., gases and liquids) upstream toward the body cavity. In other embodiments, the one-way valve 60 may not be used. Further, a flow control device 62 (e.g., a tubing clamp) 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.
[0022] Referring also to FIGS. 2-4C, operation of the drainage system 10 is illustrated. Once the connector 18 is fluidly connected to the drainage catheter 12 through the valve 20, a drainage operation may be initiated with the drainage catheter 12 already implanted within a body cavity represented by element C. To initiate the drainage operation, the fluid-receiving container 14 (e.g., a bag) may be placed on a floor such that it is lower than the body cavity C. Depending on locations and orientations of the body cavity C, the drainage conduit 16, the fluid-receiving container 14 and a pressure difference between the body cavity C and outside atmosphere, drainage flow may begin or continue without actuation of the displacement pump 28 (FIG. 4A). This is considered gravity flow.
[0023] In some instances, it may be desirable to introduce a lower pressure within the fluidreceiving passageway 17 of the drainage conduit 16 to initiate or increase bodily fluid flow. To this end, the displacement pump 28 includes the release member 42 that is connected to the piston 36 through the barrel 30 and moves relative to the outer wall 32. The release member 42 may be, for example, a switch that can be rotated relative to or along with the piston shaft 43 between the initial, locked position interlocked with the lock structure 44 to prevent movement of the piston 36 from the collapsed position and the release position disengaged with the lock structure 44. In the release position, the piston 36 is free to move toward the expanded position due to the spring force provided by the spring 40 thereby providing a negative pressure to the drainage conduit 16. In the illustrated example, the lock structure 44 comprises a notch 68 that is formed in the outer wall 32 of the barrel 30. The release member 42 includes a catch projection 70 that engages the outer wall 32 at the notch 68 in the locked position. In particular, the notch 68 may be formed by the outer wall 32 having an overhang portion 71 and a release opening 73 (FIG. 3). The overhang portion 71 can extend over the catch projection 70 with the catch projection 70 received within the notch 68. The notch 68 may be open at one end to allow the catch projection 70 to move out of the notch 68 into the release opening 73 thereby releasing the piston 36. Other suitable lock structures and release members may be used, such as tabs, latches, buttons, etc.
[0024] The displacement pump 28 may be provided to a user with the release member 42 in the locked position. In some embodiments, a movement inhibiting structure, such as a tear tab, plastic wrap, etc. may be placed on and/or around the release member 42 to inhibit unintended movement of the release member 42 and unintended operation of the displacement pump 28.
[0025] At step 100, the release member 42 may be manually rotated (FIG. 4B) by twisting the release member 42 relative to the outer wall 32 from the locked position to the release position. With the release member 42 in the release position, the catch projection 70 is moved out of the notch and clear of the overhang portion 71. Once the catch projection 70 is aligned with the release opening 70, the release member 42, piston rod 43 and piston 46 are free to move relative to the barrel 30 by the spring 40 to the expanded position of increased pump chamber 38 volume, as represented by arrow 75 of FIG. 4C. The pump chamber 38 expands in volume thereby creating a suction that is communicated through the connecting tube 46 and to the fluid-receiving passageway 17. Presence of the one-way valve 50 prevents the air from being drawn from the fluid-receiving volume 54 and back into the displacement pump 28. The other one-way valve 60 allows the negative pressure to be communicated therethrough to the drainage catheter 12. [0026] At step 102, some of the bodily fluid may travel toward the displacement pump 28 along the connecting tube 46 (FIG. 4C). The flow blocking member 48 may prevent the flow of liquid into the displacement pump 28. At this point, the drainage of the bodily fluid may occur under the influence of gravity without negative pressure being introduced to the fluid-receiving passageway 17 by the displacement pump 28. The flow control device 62 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. The fluid-receiving container 14 may be formed of a plastic sheet material that includes a line of weakness 104 that facilitates tearing of the fluid-receiving container 14 and pouring out of the contents.
[0027] The above-described drainage systems may be suitable for pleural and peritoneal drainage operations and include a displacement pump 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 pump, which is considered gravity drainage. When the piston of the displacement pump is released, the pump chamber expands and a suction is provided to the fluid-receiving passageway that passes through the drainage conduit. A flow control device (e.g., a clamp) may be provided that allows for manual control of the drainage rate, which can improve patient comfort during the drainage operation.
[0028] Embodiments can be described with reference to the following numbered clauses, with certain features laid out in the dependent clauses:
[0029] Clause 1 : A drainage system for draining bodily fluid, the drainage system comprising: a fluid-receiving body having a fluid-receiving volume located therein that is configured to receive a bodily fluid, the fluid-receiving body comprising an inlet; a drainage conduit communicatively coupled to the inlet of the fluid-receiving body, the drainage conduit being communicatively coupled to a connector that connects to a drainage catheter; and a displacement pump fluidly connected to the drainage conduit, the displacement pump comprising: a barrel including an outer wall and having a fixed internal volume; a piston sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber; a spring engaged with the barrel and the piston within the fixed internal volume; wherein the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume; and a release member connected to the piston through the barrel that moves relative to the outer wall, the release member having an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit.
[0030] Clause 2: The drainage system of clause 1, wherein the lock structure comprises a notch that is formed in the outer wall, the release member is configured to rotate out of the notch as the lock structure rotates from the locked position to the release position.
[0031] Clause 3: The drainage system of clause 2, wherein the release member includes a catch that is received by the notch.
[0032] Clause 4: The drainage system of any of clauses 1-3, wherein the release member is connected to the piston by a piston rod that extends through the internal volume of the barrel.
[0033] Clause 5: The drainage system of any of clauses 1-4, wherein the displacement pump is out-of-line with the drainage conduit.
[0034] Clause 6: The drainage system of any of clauses 1-5 further comprising a one-way valve at the inlet of the fluid-receiving body that provides a one-way fluid flow direction through the inlet and into the fluid-receiving volume, the one-way valve at the inlet inhibiting air from being drawn from the fluid-receiving volume of the fluid-receiving body due to the negative pressure.
[0035] Clause 7: The drainage system of clause 6 further comprising another one-way valve along a fluid-receiving passageway at a location between the displacement pump and the connector that inhibits fluids from passing in a direction toward the connector.
[0036] Clause 8: The drainage system of clause 7 further comprising a flow control device located along the drainage conduit.
[0037] Clause 9: The drainage system of clause 8, wherein the flow control device is located between the another one-way valve and the connector.
[0038] Clause 10: The drainage system of any of clauses 1-9, wherein the release member moves with the piston relative to the sidewall. [0039] Clause 11 : The drainage system of any of clauses 1-10, wherein the fluid-receiving body is a bag comprising a line of weakness that facilitates tearing the bag.
[0040] Clause 12: A method of forming a drainage system for draining a bodily fluid from a body cavity, the method comprising: fluidly connecting an outlet end of a drainage conduit to an inlet of a fluid-receiving body; fluidly connecting a displacement pump to the drainage conduit, the displacement pump comprising: a barrel including an outer wall and having a fixed internal volume; a piston sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber; a spring engaged with the barrel and the piston within the fixed internal volume; wherein the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume; and a release member connected to the piston through the barrel that moves relative to the outer wall, the release member having an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit; and fluidly connecting a connector to an inlet end of the drainage conduit, the connector configured to connect to a drainage catheter.
[0041] Clause 13: The method of clause 12, wherein the lock structure comprises a notch that is in the outer wall, the release member is configured to rotate out of the notch as the lock structure rotates from the locked position to the release position.
[0042] Clause 14: The method of clause 13, wherein the release member includes a catch that is received by the notch.
[0043] Clause 15: The method of any of clauses 12-14, wherein the release member is connected to the piston by a piston rod that extends through the internal volume of the barrel.
[0044] Clause 16: The method of any of clauses 12-15, wherein the displacement pump is out- of-line with the drainage conduit.
[0045] Clause 17: The method of any of clauses 12-16 further comprising fluidly connecting a one-way valve within a fluid-receiving volume of the fluid-receiving body to the outlet end of the drainage conduit, the one-way valve providing a one-way fluid flow direction through the inlet. [0046] Clause 18: The method of clause 17, wherein the one-way valve is at the inlet and inhibiting air from being drawn from the fluid-receiving volume of the fluid-receiving body due to the negative pressure
[0047] Clause 19: The method of any of clauses 12-18 further comprising placing another oneway valve along a fluid-receiving passageway at a location between the displacement pump and the connector that inhibits fluids from passing in a direction toward the connector.
[0048] Clause 20: The method of clause 19 further comprising placing a flow control device along the drainage conduit that adjusts a diameter of the fluid-receiving passageway.
[0049] 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

1. A drainage system for draining bodily fluid, the drainage system comprising: a fluid-receiving body having a fluid-receiving volume located therein that is configured to receive a bodily fluid, the fluid-receiving body comprising an inlet; a drainage conduit communicatively coupled to the inlet of the fluid-receiving body, the drainage conduit being communicatively coupled to a connector that connects to a drainage catheter; and a displacement pump fluidly connected to the drainage conduit, the displacement pump comprising: a barrel including an outer wall and having a fixed internal volume; a piston sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber; a spring engaged with the barrel and the piston within the fixed internal volume, wherein the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume; and a release member connected to the piston through the barrel that moves relative to the outer wall, the release member having an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit.
2. The drainage system of claim 1, wherein the lock structure comprises a notch that is formed in the outer wall, the release member is configured to rotate out of the notch as the lock structure rotates from the locked position to the release position.
3. The drainage system of claim 2, wherein the release member includes a catch projection that is received by the notch.
4. The drainage system of claim 1, wherein the release member is connected to the piston by a piston rod that extends through the internal volume of the barrel.
5. The drainage system of claim 1, wherein the displacement pump is out-of-line with the drainage conduit.
6. The drainage system of claim 1 further comprising a one-way valve at the inlet that provides a one-way fluid flow direction through the inlet of the fluid-receiving body and into the fluid-receiving volume, the one-way valve at the inlet of the fluid-receiving body inhibiting air from being drawn from the fluid-receiving volume of the fluid-receiving body due to the negative pressure.
7. The drainage system of claim 6 further comprising another one-way valve along a fluidreceiving passageway at a location between the displacement pump and the connector that inhibits fluids from passing in a direction toward the connector.
8. The drainage system of claim 7 further comprising a flow control device located along the drainage conduit.
9. The drainage system of claim 8, wherein the flow control device is located between the another one-way valve and the connector.
10. The drainage system of claim 1 , wherein the release member moves with the piston relative to the sidewall.
11. The drainage system of claim 1, wherein the fluid- receiving body is a bag comprising a line of weakness that facilitates tearing the bag.
12. A method of forming a drainage system for draining a bodily fluid from a body cavity, the method comprising: fluidly connecting an outlet end of a drainage conduit to an inlet of a fluid-receiving body; fluidly connecting a displacement pump to the drainage conduit, the displacement pump comprising: a barrel including an outer wall and having a fixed internal volume; a piston sealingly engaged with the outer wall within the fixed internal volume thereby dividing the fixed internal volume and providing a pump chamber; a spring engaged with the barrel and the piston within the fixed internal volume; wherein the spring biases the piston away from an initial, collapsed position of decreased pump chamber volume to an expanded position of increased pump chamber volume; and a release member connected to the piston through the barrel that moves relative to the outer wall, the release member having an initial, locked position interlocked with a lock structure to prevent movement of the piston from the collapsed position and a release position disengaged with the lock structure such that the piston moves to the expanded position due to a spring force provided by the spring thereby providing a negative pressure to the drainage conduit; and fluidly connecting a connector to an inlet end of the drainage conduit, the connector configured to connect to a drainage catheter.
13. The method of claim 12, wherein the lock structure comprises a notch that is in the outer wall, the release member is configured to rotate out of the notch as the lock structure rotates from the locked position to the release position.
14. The method of claim 13, wherein the release member includes a catch projection that is received by the notch.
15. The method of claim 12, wherein the release member is connected to the piston by apiston rod that extends through the internal volume of the barrel.
16. The method of claim 12, wherein the displacement pump is out-of-line with the drainage conduit.
17. The method of claim 12 further comprising fluidly connecting a one-way valve within a fluid-receiving volume of the fluid-receiving body to the outlet end of the drainage conduit, the one-way valve providing a one-way fluid flow direction through the inlet of the fluid-receiving body.
18. The method of claim 17, wherein the one-way valve is at the inlet and inhibiting air from being drawn from the fluid-receiving volume of the fluid-receiving body due to the negative pressure
19. The method of claim 12 further comprising placing another one-way valve along a fluidreceiving passageway at a location between the displacement pump and the connector that inhibits fluids from passing in a direction toward the connector.
20. The method of claim 19 further comprising placing a flow control device along the drainage conduit that adjusts a diameter of the fluid-receiving passageway.
PCT/US2023/062644 2023-02-15 2023-02-15 Drainage systems including biased displacement pump for providing a negative pressure for draining and collecting bodily fluids Ceased WO2024172840A1 (en)

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CN108744075A (en) * 2018-04-13 2018-11-06 中国人民解放军陆军军医大学第附属医院 A kind of syringe drainage fixing device
WO2022271155A1 (en) * 2021-06-22 2022-12-29 Bard Peripheral Vascular, Inc. Drainage system including fluid collection apparatus having a selectable negative pressure for draining and collecting bodily fluids from a body cavity

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