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WO2025059092A1 - Rotatable flow indicator - Google Patents

Rotatable flow indicator Download PDF

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Publication number
WO2025059092A1
WO2025059092A1 PCT/US2024/046064 US2024046064W WO2025059092A1 WO 2025059092 A1 WO2025059092 A1 WO 2025059092A1 US 2024046064 W US2024046064 W US 2024046064W WO 2025059092 A1 WO2025059092 A1 WO 2025059092A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
fluid
fluid communication
flow indicator
indicator device
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.)
Pending
Application number
PCT/US2024/046064
Other languages
French (fr)
Inventor
Gene E. Mason
Jason Andrew WINE
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.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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 Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of WO2025059092A1 publication Critical patent/WO2025059092A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16822—Flow controllers by controlling air intake into infusion reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16809—Flow controllers by repeated filling and emptying of an intermediate volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • A61M5/38—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
    • A61M5/385—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters using hydrophobic filters

Definitions

  • the present disclosure relates generally to a flow indication device and, more particularly, to a flow indicator for use in fluid delivery systems.
  • Fluid delivery systems are widely used to intravenously deliver therapeutics to patients. When a therapeutic is delivered intravenously, it is critical that the amount of air in the delivery line be minimized. While some existing systems are designed to control or allow for the release of air from the fluid delivery system, such as those described in U.S. Patent Nos. 8,282,608 and 10,413,662, a preferable alternative is to minimize the amount of air that can possibly be introduced. In terms of detecting flow rate within a fluid flow system, delivery of a small, precise, amount of air and use of straightforward devices is advantageous. Accordingly, there is a need in the art for improved flow indicator devices for use in fluid delivery systems.
  • a flow indicator device for a fluid delivery system, including a housing defining a chamber, the chamber configured to receive a liquid therein, an inlet in fluid communication with the chamber, an outlet in fluid communication with the chamber, a flow restrictor arranged at the inlet, and a compressible bulb comprising a hydrophobic material, the compressible bulb in fluid communication with the chamber.
  • a fluid delivery system a fluid pump, a fluid conduit having a proximal end and a distal end, the proximal end in fluid communication with the fluid pump, and a flow indicator device for a fluid delivery system, including a housing defining a chamber, the chamber configured to receive a liquid therein, an inlet in fluid communication with the chamber, an outlet in fluid communication with the chamber, a flow restrictor arranged at the inlet, and a compressible bulb comprising a hydrophobic material, the compressible bulb in fluid communication with the chamber, the flow indicator device arranged at the distal end of the fluid conduit and in fluid communication with the pump.
  • FIG. 1 is a cross-sectional view of a flow indicator device according to non-limiting embodiments described herein;
  • FIG. 2 is a cross-sectional view of a flow indicator device according to non-limiting embodiments described herein.
  • a range of “1 to 10” is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
  • devices and systems for fluid delivery including delivery of therapeutic compositions.
  • the devices described herein allow for detection of flow in a fluid delivery system, with minimum amounts of air generated and thus potentially introduced into the fluid conduits.
  • Advantages conferred by the described devices include minimal air generation and introduction into the fluid delivery system and quick and easy detection of flow rate in the fluid delivery system.
  • Flow indicator device 100 may include a housing 110, which may be formed of any suitable material, such as, for example, plastics. As shown in both FIG.l and FIG. 2, housing 110 may be formed in any suitable shape, for example spherical, frustoconical, and/or dual diameter arrangements. In non-limiting embodiments, housing 110 is at least partially translucent, and, in non-limiting embodiments, is at least partially transparent, allowing for a user to see a chamber 111 defined by housing 110. Housing 110 may include one or more inlets 112 and one or more outlets 114 therethrough, such inlet(s) and outlet(s) being in fluid communication with chamber 111.
  • one or more inlets 112 may be in fluid communication with a fluid conduit 130, which may itself be in fluid communication with a pump, such as an intravenous pump.
  • one or more inlets 112 may include a flow restriction 132. Suitable flow restrictors 132 may include those configured to produce droplets from a fluid source, such as a fluid conduit and/or intravenous pump that is in fluid communication with one or more inlets 112.
  • one or more outlets 114 may include a proximal end 116 and a distal end 118.
  • One or more outlets 114 may be in fluid communication with a fluid conduit 140.
  • a useful fluid conduit 140 may include a proximal end 142 arranged within chamber 111, which may be aligned with proximal end 116 of one or more outlets 114, and having an opening 143 therein.
  • a distal end 144 of conduit 140 may extend from one or more outlets 114, may be aligned with distal end 118 of one or more outlets 114, and may, for example, be connected to an indwelling catheter for delivery of fluids to a patient.
  • housing 110 may have a diameter (x) and a distance that proximal end 116 of one or more outlets 114 and/or proximal end 142 of fluid conduit 140 extends into chamber 111 may be at least x/2. In non-limiting embodiments, proximal end 116 of one or more outlets 114 and/or proximal end 142 of fluid conduit 140 extends at least into the center of chamber 111.
  • flow indicator device 100 includes a bulb 120, which may be formed of a compressible and, optionally, resilient, material, for example a rubber material.
  • bulb 120 includes a hydrophobic membrane separating chamber 111 from an interior of bulb 120, such that any fluid within chamber 111 cannot enter the interior of bulb 120.
  • a membrane prevents air introduced into chamber 111 by depressing bulb 120 from re-entering the interior of bulb 120.
  • bulb 120 is arranged at a specific height relative to opening 143.
  • bulb 120 may function, by being compressed, to introduce air into chamber 111. By introducing air into chamber 111 , a bubble may be formed, and may be visible to a user.
  • a user may rotate flow indicator device 100, and by doing so may position an air bubble introduced by compression of bulb 120, so as to allow a user to visualize fluid flow through flow restriction 132. In this way, a flow rate through restriction 132 can be determined, which may permit a user to determine flow from an intravenous pump and/or fluid conduit 130.
  • proximal end 142 of fluid conduit 140 and/or proximal end 116 of one or more outlets 114 air used to aid in visualization of flow rate does not enter fluid conduit 140 through opening 143.
  • orientation of housing 110 does not matter in terms of fluid flow through chamber 111.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Provided herein is a flow indicator device for a fluid delivery system, including a housing defining a chamber, the chamber configured to receive a liquid therein, an inlet in fluid communication with the chamber, an outlet in fluid communication with the chamber, a flow restrictor arranged at the inlet, and a compressible bulb comprising a hydrophobic material, the compressible bulb in fluid communication with the chamber.

Description

ROTATABLE FLOW INDICATOR
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to United States Provisional Patent Application No. 63/581,783 entitled “Rotatable Flow Indicator” filed September 11, 2023, the disclosure of which is hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present disclosure relates generally to a flow indication device and, more particularly, to a flow indicator for use in fluid delivery systems.
Description of Related Art
[0003] Fluid delivery systems are widely used to intravenously deliver therapeutics to patients. When a therapeutic is delivered intravenously, it is critical that the amount of air in the delivery line be minimized. While some existing systems are designed to control or allow for the release of air from the fluid delivery system, such as those described in U.S. Patent Nos. 8,282,608 and 10,413,662, a preferable alternative is to minimize the amount of air that can possibly be introduced. In terms of detecting flow rate within a fluid flow system, delivery of a small, precise, amount of air and use of straightforward devices is advantageous. Accordingly, there is a need in the art for improved flow indicator devices for use in fluid delivery systems.
SUMMARY OF THE INVENTION
[0004] Provided herein is a flow indicator device for a fluid delivery system, including a housing defining a chamber, the chamber configured to receive a liquid therein, an inlet in fluid communication with the chamber, an outlet in fluid communication with the chamber, a flow restrictor arranged at the inlet, and a compressible bulb comprising a hydrophobic material, the compressible bulb in fluid communication with the chamber.
[0005] Also provided herein is a fluid delivery system a fluid pump, a fluid conduit having a proximal end and a distal end, the proximal end in fluid communication with the fluid pump, and a flow indicator device for a fluid delivery system, including a housing defining a chamber, the chamber configured to receive a liquid therein, an inlet in fluid communication with the chamber, an outlet in fluid communication with the chamber, a flow restrictor arranged at the inlet, and a compressible bulb comprising a hydrophobic material, the compressible bulb in fluid communication with the chamber, the flow indicator device arranged at the distal end of the fluid conduit and in fluid communication with the pump.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is a cross-sectional view of a flow indicator device according to non-limiting embodiments described herein; and
[0007] FIG. 2 is a cross-sectional view of a flow indicator device according to non-limiting embodiments described herein.
DESCRIPTION OF THE INVENTION
[0008] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
[0009] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. [0010] It should be understood that any numerical range recited herein is intended to include all values and sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
[0011] Provided herein are devices and systems for fluid delivery, including delivery of therapeutic compositions. The devices described herein allow for detection of flow in a fluid delivery system, with minimum amounts of air generated and thus potentially introduced into the fluid conduits. Advantages conferred by the described devices include minimal air generation and introduction into the fluid delivery system and quick and easy detection of flow rate in the fluid delivery system.
[0012] Turning to FIGS. 1 and 2, shown is a flow indicator device 100 for use with a fluid delivery system. Flow indicator device 100 may include a housing 110, which may be formed of any suitable material, such as, for example, plastics. As shown in both FIG.l and FIG. 2, housing 110 may be formed in any suitable shape, for example spherical, frustoconical, and/or dual diameter arrangements. In non-limiting embodiments, housing 110 is at least partially translucent, and, in non-limiting embodiments, is at least partially transparent, allowing for a user to see a chamber 111 defined by housing 110. Housing 110 may include one or more inlets 112 and one or more outlets 114 therethrough, such inlet(s) and outlet(s) being in fluid communication with chamber 111. In non-limiting embodiments, one or more inlets 112 may be in fluid communication with a fluid conduit 130, which may itself be in fluid communication with a pump, such as an intravenous pump. In non-limiting embodiments, one or more inlets 112 may include a flow restriction 132. Suitable flow restrictors 132 may include those configured to produce droplets from a fluid source, such as a fluid conduit and/or intravenous pump that is in fluid communication with one or more inlets 112.
[0013] In non-limiting embodiments, one or more outlets 114 may include a proximal end 116 and a distal end 118. One or more outlets 114 may be in fluid communication with a fluid conduit 140. A useful fluid conduit 140 may include a proximal end 142 arranged within chamber 111, which may be aligned with proximal end 116 of one or more outlets 114, and having an opening 143 therein. A distal end 144 of conduit 140 may extend from one or more outlets 114, may be aligned with distal end 118 of one or more outlets 114, and may, for example, be connected to an indwelling catheter for delivery of fluids to a patient. In nonlimiting embodiments, housing 110 may have a diameter (x) and a distance that proximal end 116 of one or more outlets 114 and/or proximal end 142 of fluid conduit 140 extends into chamber 111 may be at least x/2. In non-limiting embodiments, proximal end 116 of one or more outlets 114 and/or proximal end 142 of fluid conduit 140 extends at least into the center of chamber 111.
[0014] With continuing reference to FIG. 1, flow indicator device 100 includes a bulb 120, which may be formed of a compressible and, optionally, resilient, material, for example a rubber material. In non-limiting embodiments, bulb 120 includes a hydrophobic membrane separating chamber 111 from an interior of bulb 120, such that any fluid within chamber 111 cannot enter the interior of bulb 120. In non-limiting embodiments, such a membrane prevents air introduced into chamber 111 by depressing bulb 120 from re-entering the interior of bulb 120. In non-limiting embodiments, bulb 120 is arranged at a specific height relative to opening 143.
[0015] In non-limiting embodiments, bulb 120 may function, by being compressed, to introduce air into chamber 111. By introducing air into chamber 111 , a bubble may be formed, and may be visible to a user. In non-limiting embodiments, a user may rotate flow indicator device 100, and by doing so may position an air bubble introduced by compression of bulb 120, so as to allow a user to visualize fluid flow through flow restriction 132. In this way, a flow rate through restriction 132 can be determined, which may permit a user to determine flow from an intravenous pump and/or fluid conduit 130. In non-limiting embodiments, due to arrangement of proximal end 142 of fluid conduit 140 and/or proximal end 116 of one or more outlets 114, air used to aid in visualization of flow rate does not enter fluid conduit 140 through opening 143. Moreover, due to the arrangement of one or more inlets 112 and one or more outlets 114, orientation of housing 110 does not matter in terms of fluid flow through chamber 111.
[0016] Having described this invention, it will be understood to those of ordinary skill in the art that the same can be performed within a wide and equivalent range of conditions, formulations and other parameters without affecting the scope of the invention or any embodiment thereof.

Claims

THE INVENTION CLAIMED IS
1. A flow indicator device for a fluid delivery system, comprising: a housing defining a chamber, the chamber configured to receive a liquid therein; an inlet in fluid communication with the chamber; an outlet in fluid communication with the chamber; a flow restrictor arranged at the inlet; and a compressible bulb comprising a hydrophobic material, the compressible bulb in fluid communication with the chamber.
2. The flow indicator device of claim 1, wherein the flow restrictor is configured to create droplets of a fluid passing therethrough.
3. The flow indicator device of claim 1, wherein the outlet is arranged within the chamber.
4. The flow indicator device of claim 3, wherein the outlet protrudes inward into the chamber from a first location on the housing opposite a second location on the housing where the input is arranged.
5. The flow indicator device of claim 4, wherein the outlet protrudes into the chamber at least halfway to the input.
6. A fluid delivery system comprising: a fluid pump; a fluid conduit comprising a proximal end and a distal end, the proximal end in fluid communication with the fluid pump; and the flow indicator device arranged at the distal end of the fluid conduit and in fluid communication with the pump, the flow indicator device comprising: a housing defining a chamber, the chamber configured to receive a liquid therein; an inlet in fluid communication with the chamber; an outlet in fluid communication with the chamber; a flow restrictor arranged at the inlet; and a compressible bulb comprising a hydrophobic material, the compressible bulb in fluid communication with the chamber.
7. The fluid delivery system of claim 6, wherein the flow restrictor is configured to create droplets of a fluid passing therethrough.
8. The fluid delivery system of claim 6, wherein the outlet is arranged within the chamber.
9. The fluid delivery system of claim 8, wherein the outlet protrudes inward into the chamber from a first location on the housing opposite a second location on the housing where the input is arranged.
10. The fluid delivery system of claim 9, wherein the outlet protrudes into the chamber at least halfway to the input.
PCT/US2024/046064 2023-09-11 2024-09-11 Rotatable flow indicator Pending WO2025059092A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363581783P 2023-09-11 2023-09-11
US63/581,783 2023-09-11

Publications (1)

Publication Number Publication Date
WO2025059092A1 true WO2025059092A1 (en) 2025-03-20

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4271014A (en) * 1977-08-25 1981-06-02 Extracorporeal Medical Specialties, Inc. Dialysis apparatus and technique
US5074839A (en) * 1989-08-24 1991-12-24 Hemotrans, Inc. Blood transfer apparatus
US20030040709A1 (en) * 2001-08-22 2003-02-27 Mason Jeffrey T. Medication delivery system having selective automated or manual discharge
US6640649B1 (en) * 1999-01-14 2003-11-04 S.F.M. Sophisticated Flow Meters Ltd. Droplet counter for low flow rates
US20100063445A1 (en) * 2008-09-09 2010-03-11 Baxter International Inc. Device to Indicate Priming of an Infusion Line
US20170216516A1 (en) * 2016-01-28 2017-08-03 Deka Products Limited Partnership Apparatus for monitoring, regulating, or controlling fluid flow
US10737023B2 (en) * 2016-08-24 2020-08-11 Avent, Inc. Flow indicator for an infusion pump
US20200316279A1 (en) * 2019-04-02 2020-10-08 Fresenius Medical Care Holdings, Inc. Air management device for dialysis machines

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4271014A (en) * 1977-08-25 1981-06-02 Extracorporeal Medical Specialties, Inc. Dialysis apparatus and technique
US5074839A (en) * 1989-08-24 1991-12-24 Hemotrans, Inc. Blood transfer apparatus
US6640649B1 (en) * 1999-01-14 2003-11-04 S.F.M. Sophisticated Flow Meters Ltd. Droplet counter for low flow rates
US20030040709A1 (en) * 2001-08-22 2003-02-27 Mason Jeffrey T. Medication delivery system having selective automated or manual discharge
US20100063445A1 (en) * 2008-09-09 2010-03-11 Baxter International Inc. Device to Indicate Priming of an Infusion Line
US20170216516A1 (en) * 2016-01-28 2017-08-03 Deka Products Limited Partnership Apparatus for monitoring, regulating, or controlling fluid flow
US10737023B2 (en) * 2016-08-24 2020-08-11 Avent, Inc. Flow indicator for an infusion pump
US20200316279A1 (en) * 2019-04-02 2020-10-08 Fresenius Medical Care Holdings, Inc. Air management device for dialysis machines

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