WO2021092284A1 - Système d'administration de fluide à pression différentielle - Google Patents

Système d'administration de fluide à pression différentielle Download PDF

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Publication number
WO2021092284A1
WO2021092284A1 PCT/US2020/059278 US2020059278W WO2021092284A1 WO 2021092284 A1 WO2021092284 A1 WO 2021092284A1 US 2020059278 W US2020059278 W US 2020059278W WO 2021092284 A1 WO2021092284 A1 WO 2021092284A1
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WO
WIPO (PCT)
Prior art keywords
pressure
chamber
medication
delivery
fluid
Prior art date
Application number
PCT/US2020/059278
Other languages
English (en)
Inventor
Paul Lambert
Cesar Perez
Carlos Gutierrez
Neal DE BEER
Travis F. SCHRAEDER
Original Assignee
Bio Health Frontiers, 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 Bio Health Frontiers, Inc. filed Critical Bio Health Frontiers, Inc.
Priority to BR112022008891A priority Critical patent/BR112022008891A2/pt
Priority to EP20816780.9A priority patent/EP4054675A1/fr
Priority to AU2020380930A priority patent/AU2020380930A1/en
Priority to US17/774,100 priority patent/US20230109668A9/en
Priority to CA3159565A priority patent/CA3159565A1/fr
Publication of WO2021092284A1 publication Critical patent/WO2021092284A1/fr

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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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14526—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons the piston being actuated by fluid pressure
    • 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
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A—HUMAN NECESSITIES
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    • 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
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A61M5/16881—Regulating valves
    • 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
    • A61M5/16886—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 for measuring fluid flow rate, i.e. flowmeters
    • A61M5/16895—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 for measuring fluid flow rate, i.e. flowmeters by monitoring weight change, e.g. of infusion container
    • 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
    • A61M5/178—Syringes
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    • 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
    • A61M5/48—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 having means for varying, regulating, indicating or limiting injection pressure
    • A61M5/484—Regulating injection pressure
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M2005/14513—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons with secondary fluid driving or regulating the infusion
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M2005/14573—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for quick connection/disconnection with a driving system
    • 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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M2005/16863—Occlusion detection
    • A61M2005/16868—Downstream occlusion sensors
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3351—Controlling upstream pump pressure
    • A—HUMAN NECESSITIES
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    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3355—Controlling downstream pump pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3389—Continuous level detection
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3393—Masses, volumes, levels of fluids in reservoirs, flow rates by weighing the 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards

Definitions

  • the disclosure relates generally to medicament delivery devices and, in particular, to a closed-loop infusion pump apparatus that can be reusable or partly reusable which utilizes differential pressure measurements.
  • a medicinal fluid is required to be administered to the patient at a certain fluid flow rate and fluid volume to be optimized therapeutically. For example, in some applications, if the medicinal fluid is infused too slowly, the intended therapeutic effect may be diminished or totally non-existent. In other applications, infusion of a medicinal fluid into the body at too high a rate can create unintended side effects. Thus, in a number of infusion therapy applications it is important for the user to be able to quickly and accurately determine the rate of fluid flow through an infusion system, so that the flowrate can be monitored and adjusted as needed.
  • a system for delivering a medicinal fluid to a patient includes a variable volume pressure delivery chamber, a variable volume medication chamber, a movable delivery element, a pressure source, and a control sub-system.
  • the variable volume pressure delivery chamber is configured to store pressure controllably.
  • the variable volume medication chamber is fluidically isolated from the pressure delivery chamber and is configured to store medicinal fluid and having an outlet forming a fluid communication path to the patient.
  • the movable delivery element is disposed between the medication chamber and the pressure delivery chamber.
  • the pressure source is coupled (either directly or indirectly) to the pressure delivery chamber.
  • the control system is configured to selectively cause the pressure source to deliver pressure to the pressure delivery chamber causing the movable delivery element to apply pressure to the medicinal fluid in the medication chamber thereby causing the medicinal fluid to exit the medication chamber at the outlet along the fluid communication path to the patient.
  • the movable delivery element can take many forms.
  • the movable delivery element can be at least partially movable within at least a portion of the medication chamber.
  • the movable delivery element can be at least partially deformable.
  • the movable delivery element can include one or more of a gasket, a syringe plunger, an elastomeric element, a bellows element with collapsible sides, a membrane, or a balloon.
  • a volume of the pressure delivery chamber can vary based on an amount of pressure delivered by the pressure source or an amount of pressure within the medication chamber.
  • the medication chamber can include at least a portion of a medication container such as a syringe (e.g., pre-filled syringe, etc.).
  • a medication container such as a syringe (e.g., pre-filled syringe, etc.).
  • the medication container can be detachably secured to the medication chamber (and forming part of the medication chamber when secured).
  • a valve manifold can be disposed between the pressure source and the pressure delivery chamber for selectively delivering (i.e., increasing pressure and/or decreasing pressure, etc.) pressure from the pressure source to the pressure delivery chamber in response to receiving a signal from the control sub-system.
  • a position sensor can be coupled or adjacent to the medication chamber which is in communication with the control sub-system.
  • the position sensor can generate data indicative of a volume of medicinal fluid within the medication chamber.
  • the control sub system can calculate a flow rate and/or volume of the medicinal fluid exiting the outlet of the medication chamber based on the data generated by the position sensor.
  • a flow sensor can be coupled or adjacent to the medication chamber which is in communication with the control sub-system.
  • the flow sensor can generate data indicative of a rate of flow of medicinal fluid exiting the medication chamber.
  • the control sub-system can calculate a flow rate and/or volume of the medicinal fluid exiting the outlet of the medication chamber based on the data generated by the flow sensor.
  • a mass sensor can be coupled or adjacent to the medication chamber which is in communication with the control sub-system.
  • the mass sensor can generate data indicative of a mass of medicinal fluid within the medication chamber.
  • the control sub-system calculates a flow rate and/or volume of the medicinal fluid exiting the outlet of the medication chamber based on the data generated by the mass sensor.
  • a medication chamber pressure sensor can be coupled or adjacent to the medication chamber which is in communication with the control sub-system.
  • the medication chamber pressure sensor can generate data indicative a level of pressure in the medication chamber.
  • the control sub-system can calculate a volume and/or a flow rate of the medicinal fluid exiting the outlet of the medication chamber based on the data generated by the medication chamber pressure sensor.
  • a pressure delivery chamber pressure sensor can be coupled to or adjacent to the pressure delivery chamber which is in communication with the control sub-system and can generate a first pressure value characterizing a level of pressure within a pressure delivery chamber.
  • a reference pressure chamber pressure sensor can be coupled to or adjacent to the reference pressure chamber which is in communication with the control sub system and can generate a second pressure value characterizing a level of pressure within the reference pressure chamber.
  • the control sub-system can calculate an amount of medical fluid amount within the medication chamber based on a differential pressure measurement using the first pressure values and the second pressure value. In some variations, the control sub-subsystem can further calculate occlusions within the fluid communication path using the first pressure values and the second pressure values.
  • a medication chamber pressure sensor can be coupled to or adjacent to the medication chamber which is in communication with the control sub-system and which generates a pressure value characterizing a level of pressure within the medication chamber.
  • the control sub-system can calculate an amount of medical fluid amount within the medication chamber based on a differential pressure measurement using the first pressure values and the second pressure value.
  • the pressure source can take various forms including an elastomeric balloon, a pressurized chamber, an electromechanical air pump, a piezoelectric air pump, and the like.
  • the fluid delivery system can be configured to couple or otherwise include a medication reservoir coupled to the medication chamber holding additional medicinal fluid.
  • the control sub-system in turn, can be configured to automatically extract the additional medicinal fluid from the medication reservoir to the medication chamber.
  • a bubble detection sensor can be coupled to or adjacent to the medication chamber which is in communication with the control sub-system which is configured to identify bubbles within the medicinal fluid.
  • a bubble elimination system can be coupled to or adjacent to the medication chamber which is in communication with the control sub- system which is configured to selectively remove bubbles within the medicinal fluid identified by the bubble detection sensor.
  • An occlusion detection sensor can be coupled to or adjacent to the medication chamber which is in communication with the control sub-system configured to identify an occlusion within the fluid communication path.
  • a user interface can be included which has a display and at least one input element configured to alter a parameter associated with delivery of the medicinal fluid to the patient.
  • the form factor of the fluid delivery system can vary depending on the application.
  • the fluid delivery system is handheld such that a housing can be held in one hand by a user and the at least one input element can be activated by the other hand of the user.
  • the housing can encapsulate each of the pressure delivery chamber, the medication chamber, the movable delivery element, the pressure source, and the control sub-system.
  • Other components described herein can also be within the housing unless otherwise specified.
  • the form factors may include pole mounted, ambulatory or wearable devices.
  • the control sub-system can include or otherwise connect to a communications interface configured to bi-directionally exchange data over a communications network with a remote computing device (e.g., cloud system, a mobile phone, another medical device, etc.) associated with delivery of the medicinal fluid.
  • a remote computing device e.g., cloud system, a mobile phone, another medical device, etc.
  • medicinal fluid is delivered to a patient using a fluid delivery system having a pressure delivery chamber, a medication chamber, and a reference chamber.
  • pressure is monitored within the pressure delivery chamber, the medication chamber housing the medicinal fluid or a reference chamber having a known pressure level.
  • a pressure source coupled to the pressure delivery chamber is selectively activated to increase or decrease a level of pressure within the pressure delivery chamber based on the respective monitoring.
  • the increase in pressure in the pressure delivery chamber causes a movable delivery element between the pressure delivery chamber and the medication chamber to apply pressure to the medication chamber thereby causing medicinal fluid to be delivered along a fluid communication path to the patient.
  • FIG. l is a block diagram of an infusion pump system for delivering a medicine or drug to a patient
  • FIG. 2 is a first diagram illustrating an infusion pump system as in FIG. 1;
  • FIG. 3 is a second diagram illustrating an infusion pump system as in FIG. 1;
  • FIG. 4 is a third diagram illustrating an infusion pump system as in FIG. 1.
  • FIG. 1 is block diagram 100 illustrating components that form part of a fluid delivery system 102 which can be configured to provide medicinal fluid to a patient 104 over a fluid communication path 146.
  • the fluid delivery system 102 can include a control sub system 108 which is in electrical communication with various other components as described below.
  • the control sub-system 108 can include a communications 110 which allows for bi directional transfer of data to a remote computing device such as a cloud communication server, a proximate computing device (e.g., via a BLUETOOTH connection, etc.) and /or to a wireless network (e.g., cellular, WiFi, etc.).
  • the control sub-subsystem 108 can include software which can be loaded into memory 118 for execution by a processor 116 (e.g., a microprocessor, a multi-core CPU, multi-core GPU, system on a chip (SoC), etc.).
  • the memory can be used to implement programming instructions received either via the communications interface 110 or, in some variations, a user interface 124.
  • control sub-system 110 can be embedded in firmware 114.
  • the control sub-system includes sensor controls 120 which provide communication interfaces with a plurality of on-board sensors forming part of the fluid delivery system 102.
  • Software 112 and/or the firmware 114 can be executed by the processor 116 to cause the sensor controls 120 to, in turn, perform a particular action and/or to receive measurement data from such sensors.
  • the control sub-system 108 can include a power source 122 such as battery and, optionally, in some variations, on-board recharging circuitry.
  • control sub-system 108 such as the power source 122 can be external to the control sub-system 108 but within a housing forming part of the fluid delivery system 102 or, alternatively, components such as the power source 122 can be external and separate from the fluid delivery system 102 (e.g., a hard-wired electricity connection, etc.).
  • the user interface 124 can comprise an electronic visual display 126 to convey certain information relating to the delivery of fluid.
  • the electronic visual display 126 is a touch-screen interface allowing for selection of displayed graphical user interface elements associated with the operation of the fluid delivery system 102.
  • there can be dedicated physical elements such as a LED indicator 128 which can, convey a status of the fluid delivery system 102 such as on / off, operating, error, etc.
  • An alarm element 130 can display a visual indicator associated with the operation of the fluid delivery system 102.
  • the alarm element 130 can convey an audio signal and in other variations the alarm can convey both a visual indicator and convey an audio signal.
  • Various physical buttons 132 can also be provided to allow a user (such as the patient 104 when medicinal fluid is self-administered, etc.) to obtain information associated with the operation and control of the fluid delivery system 102.
  • One of the major functions of the control sub-system 108 is to control and drive a pressure source 134 in combination with a valve manifold 136 which can cause pressure originating from the pressure source 134 to be selectively delivered to other components within the fluid delivery system.
  • the pressure source 134 can be an elastomeric device that is pressurized with water or another impelling fluid, but the impelling fluid is fluidly isolated from the medicinal fluid contained within a medication chamber 144.
  • the pressure source 134 is an air pump (e.g., a piezoelectric air pump, etc.) that includes an air chamber adapted to be pressurized with air.
  • the pressure source 134 can be utilized multiple times.
  • the pressure source 134 can serve as an engine that propels the medicinal fluid out of a separate, fluidly isolated medication chamber 144 so that the medicinal fluid does not contact the pressure delivery chamber 140 but instead flows directly into the patient propelled by the pressure in the pressure delivery chamber 140 (which reduces costs of any single use components / disposables and/or the medication chamber 144).
  • the valve manifold 136 can be an electro-mechanical valve system that is controlled by the control sub-system 108 (either integrated into a single unit as illustrated or distributed across multiple electro-mechanical valves). Each individual valve, can for example, be a solenoid valve.
  • the pressure source 134 in combination with the valve manifold 136 can cause a variable volume pressure delivery chamber 140 to be selectively pressurized.
  • the addition of pressurized fluid (e.g., air or other gas, fluid, etc.) from the pressure source 134 can cause the pressure delivery chamber 140 to apply pressure to a medication chamber 144.
  • the medication chamber 144 can comprise a dedicated container for housing a fluid such as a medicinal fluid or, in other variations, the medication chamber 144 can have a shape and size to receive an external medication container such as a pre-filled syringe (without a plunger, etc.) or vial. Because the fluid delivery system 102 can use pre-filled syringes and vials there is no need to transfer the drug or medicine from a manufacturing format container to a subsequent delivery reservoir.
  • a movable delivery element 142 can be disposed between the pressure delivery chamber 140 and the medication chamber 144 which fluidically isolates (thus preserving sterility, etc.) such chambers 140, 144 while, at the same time, imparting pressure on the medication chamber 144 which, in turn, causes fluid disposed therein to be delivered to the patient 104 along a fluid communication path 146.
  • the movable delivery element 142 can take different forms including an elastomeric membrane which is at least partially fixed and has movable and/or deformable elements, an expandable balloon (which expands into the medication chamber 144 when pressure is delivered to the pressure delivery chamber 140), a plunger-like element, a gasket, a bellows element with collapsible sides and the like.
  • Isolating fluidic contact between the medication chamber 144 and the pressure source 134 / pressure delivery chamber eliminates any drug incompatibility issue or leaching issue with the medicinal fluid and the impelling fluid and the medicine and the first chamber, respectively, because the medicinal fluid does not come into contact with the impelling fluid or gas.
  • the medication chamber 144 can be selectively coupled to a medication reservoir 168.
  • the medication reservoir 168 can hold additional medicinal fluid (or the first fill for the patient) for delivery to the patient via the medication chamber 144 and the fluid communication path 146.
  • the medication reservoir 168 can take various forms including a pre-filled syringe, a vial, a bag and the like.
  • the medication reservoir 168 is selectively attachable to the fluid delivery system 102 for example, by a Luer lock or other physical connection system / tubing set.
  • pressure applied from the pressure delivery chamber 140 can cause a suction effect when an opening between the medication reservoir 168 and the medication chamber 144 is open thereby drawing fluid from the medication reservoir 168 into the medication chamber 144.
  • the fluid delivery system 102 can optionally include a fixed volume reference chamber 160 and/or an atmospheric port 164 each of which may have a corresponding pressure sensor 162, 166. These pressure sensors 162, 166 can generate pressure measurements which are then provided to the control sub-system 108 can take various forms including, for example absolute pressures, gauge pressures, or differential pressures between different pressure sensors.
  • the pressure delivery chamber 140 can also include a dedicated pressure sensor 138.
  • the medication chamber 144 can also include an additional pressure sensor 150. In some cases, an additional pressure sensor 148 is present along the fluid communication path 146.
  • the outputs of two or more of the pressure sensors 138, 148, 150, 162, and 166 can be used by the control sub-system 108 to determine one or more parameters relating to delivery of fluid to the patient 104 including, for example, algorithms to derive from pressure measurements, flow rate and/or volume of fluid remaining, etc.
  • Pressure sensor 148 at the patient 104 is helpful to monitor the pressure of the medicinal fluid that is applied to the patient 104 which is a direct way to control the pressure profile.
  • the outputs of pressure sensor 138 and pressure sensor 162 provide an indirect way to control the volume without using other sensors including pressure sensor 148.
  • the control sub-system 108 by way of the data processor 116 can cause the pressure source 134 in concert with the valve manifold 136 to selectively deliver pressurized air / fluid to the pressure delivery chamber 140 to effect a desired output (e.g., flow rate, volume, refill, etc.) of fluid in the medication chamber 144.
  • a desired output e.g., flow rate, volume, refill, etc.
  • a dedicated flow sensor 152 can monitor a rate of flow of fluid (e.g., medicinal fluid) exiting the medication chamber 144 and/or entering the medication chamber 144 from the medication reservoir.
  • a mass sensor 154 can be used to determine a mass and/or density of fluid in the medication chamber 144 which, in turn, can be used by the sub-control sub system 108 to determine a change of volume of fluid within the medication chamber 144 which can be used to determine flow rate and/or volume, etc.
  • a position sensor 168 can be utilized which can identify a position of one or more of the movable delivery element 142 within the medication chamber 144, a level of fluid within the medication chamber 144 and/or a position of a movable element such as a pre-filled syringe plunger forming part of the medication chamber 144. Still further, an air bubble system 158 can be provided that identifies whether there are any bubbles within medication chamber 144 but at least within communication path 146 which, in turn, could pose problems for the patient 104.
  • a priming routine or other air bubble removal technique may be initiated by the control sub-system 108 in concert with the pressure source 134, one or more of the pressure sensors 138, 148, 150, 162, 166, and the valve manifold 136.
  • the control sub-system 108 can generate signals that cause the pressure source 134 in concert with the valve manifold 136 to dispense medicinal fluid out of the medication chamber 144 at a desired steady flow rate, or in a stepped manner (i.e., changing a pressure level at certain intervals for specific periods of time) to deliver a series of discrete medicinal fluid volumes.
  • the operation used often depends on the drug regimen. For instance, diabetes patients usually need a continuous, low "basal" rate of insulin, in addition to high-rate, short- duration "bolus" deliveries before or after meals.
  • the patient 104 or caregiver can use the user interface 124 to enter at least one parameter for controlling the delivery of the medicinal fluid to the patient 104, corresponding to either a rate of fluid flow, a volume of fluid flow, a time of fluid flow, and/or a duration of fluid flow.
  • the fluid delivery system 102 can control flow rate and/or volume and/or pressure profiles independently and as such, improve therapy mode control and optimization of clinical benefits.
  • FIGs. 2-4 are diagrams illustrating one implementation of a hand-held fluid delivery system in which the medication chamber 144 comprises a lid 210 which may be opened so that a container such as a pre-filled syringe 220 can be inserted therein.
  • the pre filled syringe can, in some variations, be mechanically and fluidically coupled to the fluid delivery system 102 using a mechanical connector 230 (such as a Luer lock compatible with threads on a tip of the pre-filled syringe or a proprietary connector) thus forming part of the medication chamber 144.
  • the medical container such as the pre-filled syringe does not form part of the medication chamber 144.
  • FIG. 1 is illustrating one implementation of a hand-held fluid delivery system in which the medication chamber 144 comprises a lid 210 which may be opened so that a container such as a pre-filled syringe 220 can be inserted therein.
  • the pre filled syringe can, in some variations, be mechanically and fluid
  • the pre-filled syringe is connected to coupler 240 which is configured to interconnect hermetically with connector 230.
  • the lid 210 may be opened so that the pre-filled syringe 220 may be secured to the connector 230 with a leak-proof connection. Further, the lid 210 can then be closed. In some variations, the lid 210 completely covers the pre-filled syringe 220 when closed. In some other variations, the lid 210 may be replaced by a reservoir entirely.
  • One or more aspects or features of the subject matter described herein can be realized in digital electronic circuitry, integrated circuitry, specially designed application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) computer hardware, firmware, software, and/or combinations thereof.
  • ASICs application specific integrated circuits
  • FPGAs field programmable gate arrays
  • These various aspects or features can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.
  • the programmable system or computing system may include clients and servers.
  • a client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.
  • machine-readable signal refers to any signal used to provide machine instructions and/or data to a programmable processor.
  • the machine-readable medium can store such machine instructions non- transitorily, such as for example as would a non-transient solid-state memory or a magnetic hard drive or any equivalent storage medium.
  • the machine-readable medium can alternatively or additionally store such machine instructions in a transient manner, such as for example as would a processor cache or other random access memory associated with one or more physical processor cores.
  • phrases such as “at least one of’ or “one or more of’ may occur followed by a conjunctive list of elements or features.
  • the term “and/or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features.
  • the phrases “at least one of A and B;” “one or more of A and B;” and “A and/or B” are each intended to mean “A alone, B alone, or A and B together.”
  • a similar interpretation is also intended for lists including three or more items.
  • the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.”
  • use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

Landscapes

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

Abstract

Système d'administration d'un fluide médical à un patient comprenant une chambre de distribution de pression à volume variable, une chambre de médicament à volume variable, un réservoir de médicament facultatif, un élément de distribution mobile, une chambre à volume de référence fixe, une source de pression et un sous-système de commande. La chambre de distribution de pression à volume variable est conçue pour stocker une pression de manière contrôlée. La chambre de médicament à volume variable est isolée fluidiquement de la chambre de distribution de pression et est conçue pour stocker un fluide médical. L'élément de distribution mobile est disposé entre la chambre de médicament et la chambre de distribution de pression. La source de pression est couplée à la chambre de distribution de pression. Le système de commande est conçu pour amener sélectivement la source de pression à délivrer une pression en direction de la chambre de distribution de pression, ce qui amène l'élément de distribution mobile à appliquer une pression sur le fluide médical présent dans la chambre de médicament, avec pour résultat que le fluide médical sort de la chambre de médicament au niveau d'un orifice de sortie le long du trajet de communication fluidique jusqu'au patient.
PCT/US2020/059278 2019-11-08 2020-11-06 Système d'administration de fluide à pression différentielle WO2021092284A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
BR112022008891A BR112022008891A2 (pt) 2019-11-08 2020-11-06 Sistema de distribuição de fluido de pressão diferencial
EP20816780.9A EP4054675A1 (fr) 2019-11-08 2020-11-06 Système d'administration de fluide à pression différentielle
AU2020380930A AU2020380930A1 (en) 2019-11-08 2020-11-06 Differential pressure fluid delivery system
US17/774,100 US20230109668A9 (en) 2019-11-08 2020-11-06 Differential Pressure Fluid Delivery System
CA3159565A CA3159565A1 (fr) 2019-11-08 2020-11-06 Systeme d'administration de fluide a pression differentielle

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962933233P 2019-11-08 2019-11-08
US62/933,233 2019-11-08

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AU (1) AU2020380930A1 (fr)
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Publication number Priority date Publication date Assignee Title
WO2023150141A1 (fr) * 2022-02-02 2023-08-10 Becton, Dickinson And Company Appareils et procédés de détection de volume de remplissage utilisateur dans un dispositif d'administration de médicament

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US20080139996A1 (en) * 2006-12-09 2008-06-12 Bowman Sam W Ambulatory Infusion Devices and Methods
US7654127B2 (en) * 2006-12-21 2010-02-02 Lifescan, Inc. Malfunction detection in infusion pumps
US20100262078A1 (en) * 2009-03-31 2010-10-14 Smiths Medical Asd, Inc. Systems and methods to address air, leaks and occlusions in an insulin pump system
WO2013075109A2 (fr) * 2011-11-18 2013-05-23 Minipumps, Llc Commande d'écoulement précis dans dispositifs de pompe à médicaments
WO2017123703A2 (fr) * 2016-01-14 2017-07-20 Bigfoot Biomedical, Inc. Résolution d'occlusion dans des dispositifs, des systèmes et des procédés d'administration de médicaments
EP3278825A2 (fr) * 2012-11-29 2018-02-07 Becton, Dickinson and Company Commande sélective d'un é?coulement de fluide à? travers un passage de fluide

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Publication number Priority date Publication date Assignee Title
US20080139996A1 (en) * 2006-12-09 2008-06-12 Bowman Sam W Ambulatory Infusion Devices and Methods
US7654127B2 (en) * 2006-12-21 2010-02-02 Lifescan, Inc. Malfunction detection in infusion pumps
US20100262078A1 (en) * 2009-03-31 2010-10-14 Smiths Medical Asd, Inc. Systems and methods to address air, leaks and occlusions in an insulin pump system
WO2013075109A2 (fr) * 2011-11-18 2013-05-23 Minipumps, Llc Commande d'écoulement précis dans dispositifs de pompe à médicaments
EP3278825A2 (fr) * 2012-11-29 2018-02-07 Becton, Dickinson and Company Commande sélective d'un é?coulement de fluide à? travers un passage de fluide
WO2017123703A2 (fr) * 2016-01-14 2017-07-20 Bigfoot Biomedical, Inc. Résolution d'occlusion dans des dispositifs, des systèmes et des procédés d'administration de médicaments

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023150141A1 (fr) * 2022-02-02 2023-08-10 Becton, Dickinson And Company Appareils et procédés de détection de volume de remplissage utilisateur dans un dispositif d'administration de médicament

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EP4054675A1 (fr) 2022-09-14
CA3159565A1 (fr) 2021-05-14

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