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NL2026585B1 - Fluid resuscitation device - Google Patents

Fluid resuscitation device Download PDF

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Publication number
NL2026585B1
NL2026585B1 NL2026585A NL2026585A NL2026585B1 NL 2026585 B1 NL2026585 B1 NL 2026585B1 NL 2026585 A NL2026585 A NL 2026585A NL 2026585 A NL2026585 A NL 2026585A NL 2026585 B1 NL2026585 B1 NL 2026585B1
Authority
NL
Netherlands
Prior art keywords
fluid
patient
container
delivery device
temperature
Prior art date
Application number
NL2026585A
Other languages
Dutch (nl)
Inventor
Gerhardus Kritzinger Hendrik
Stefanus Meyer Johannes
Original Assignee
Stefanus Meyer Johannes
Gerhardus Kritzinger Hendrik
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 Stefanus Meyer Johannes, Gerhardus Kritzinger Hendrik filed Critical Stefanus Meyer Johannes
Priority to NL2026585A priority Critical patent/NL2026585B1/en
Application granted granted Critical
Publication of NL2026585B1 publication Critical patent/NL2026585B1/en

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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
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • 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
    • A61M5/44Devices 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 cooling or heating the devices or media
    • 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
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3334Measuring or controlling the flow rate
    • 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
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3344Measuring or controlling pressure at the body treatment site
    • 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
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • 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
    • A61M2205/35Communication
    • 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
    • A61M2205/36General characteristics of the apparatus related to heating or cooling
    • A61M2205/366General characteristics of the apparatus related to heating or cooling by liquid heat exchangers
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407Infusion of two or more substances
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14212Pumping with an aspiration and an expulsion action
    • A61M5/14232Roller pumps
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/155Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by gas introduced into the reservoir
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/172Means 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 electrical or electronic
    • A61M5/1723Means 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 electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure

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

This invention relates to a fluid resuscitation device comprising a housing, a fluid feed line having an inlet which is connectable to a container holding a fluid and an outlet connectable to a cannula to administer the fluid to a patient, and a peristaltic pump configured to act on a portion of the fluid feed line transfuse the fluid from the container to the patient via the fluid feed line. The fluid resuscitation device further includes regulating means which operatively regulate the temperature and pressure at which the fluid is transfused to the patient and a controller for controlling the pressure and temperature of the fluid being transfused to the patient.

Description

P34794NL0O0/JV Title: FLUID RESUSCITATION DEVICE
INTRODUCTION AND BACKGROUND This invention relates to a fluid resuscitation device and a method of treating a patient who has entered or who is at a risk of entering haemorrhagic and/or or hypovolaemic shock. More specifically, the invention relates to a portable fluid resuscitation device which can deliver essential fluids with controlled high pressure and high flow delivery to a patient. These essential fluids are required rapidly during treatment of haemorrhagic and/or hypovolaemic shock. Haemorrhagic shock is the result of rapid blood loss, and often results in a medical condition called hypovolaemic shock, which is the result of a sudden severe drop of 20% or more in blood volume of a patient, predominantly due to a traumatic event such as a motor vehicle accident. The effects of a traumatic injury are generally referred to as the “deadly triad”, or the “trauma triad of death”, comprising hypothermia, acidosis and coagulopathy. The sudden decrease in blood volume prohibits the heart from pumping a sufficient amount of blood to the body and organs. This condition disrupts physiological homeostasis, which may lead to hypothermia, or a core body temperature below 35°C. Hypothermia affects the ability of blood to clot, and continued blood loss may lead to metabolic acidosis, wherein the pH of the body drops below 7.35. This may result in tissue death of organs, often resulting in serious additional and permanent medical complications for the patient.
Hypovolaemic shock is generally treated with a method known as intravenous fluid resuscitation, which can range from replacement of a relatively low volume of blood products or intravenous fluid, to what is referred to as “Massive blood transfusion”, during which high volumes of whole blood and/or packed red blood cells and/or fresh frozen plasma and/or platelets and/or other intravenously administered fluids such as saline are introduced into the body to counter a sudden decrease in blood volume. The method generally comprises passive infusion of volumizing fluid by gravitational force, where a fluid containing sachet or other container is elevated above the patient and connected to the patient by way of an intravenous line, and with fluid then flowing from the container into the bloodstream of the patient under the force of gravity. Alternatively, the fluid may be transfused to the patient by manually drawing blood from a container using a syringe of adequate size and then injecting the drawn blood into the patient's bloodstream. Further alternatively, fluids may be infused to patients by infusion pumps in a specialized medical setting. These methods demand time and effort of a medical practitioner during a crucial period within which the medical practitioner has to make complex decisions and also has to tend to potentially life-threatening injuries of the patient. The main purpose of intravenous fluid resuscitation is to restore intravascular fluid volume in order to improve cardiac preload of the patient which ultimately improves oxygenated blood flow to essential organs. The primary objective of intravenous fluid resuscitation is therefore to delay detrimental cellular metabolism and subsequent tissue death, to restore homeostasis and furthermore, to extend a brief window of opportunity for a successful resuscitation without permanent tissue damage.
Further disadvantages include limitations to the rate and efficacy of the transfusion of fluids to the patient due to constraints of having to administer fluid manually. Transfusion fluids, and in particular blood products, are generally stored in controlled storage, which regulates storage temperatures between 1°C to 6°C. In accordance with best practice and in ideal circumstances, transfusion fluids need to be transfused to a patient at room temperature within four hours from removal from the controlled storage to prevent denaturation of the blood products. However, during emergency fluid resuscitation, it is desirable to increase the temperature of blood being transfused to a patient to a temperature level that is closer to a normal temperature of 36,6°C (+/- 0,5°C). This higher temperature is required in order to prevent the patient from becoming hypothermic due to the sudden influx of fluid that is significantly cooler than normal body temperature.
Patients who have suffered blood loss which is significant enough to result in hypovolaemic shock are often at remote locations that are not in the immediate vicinity of medical facilities, such as on roads, or at work sites such as construction sites and mines where heavy machinery is operated, or even during conflict situations.
When hypovolaemic shock sets in, fast and effective balanced volume fluid resuscitation is essential, especially in a situation of continuous blood loss.
Known methods of fluid resuscitation have the disadvantage that it is laborious for the medical practitioner during a period in which the time and effort of the medical practitioner can be spent much more effectively towards addressing the patient's injuries, in order to save the patient's life, or to minimise long term effect of blood loss following a traumatic incident.
OBJECT OF THE INVENTION
Accordingly, it is an object of the present invention to provide a fluid resuscitation device, with which the applicant believes the aforementioned disadvantages may at least partially be alleviated or which may provide a useful alternative for the known systems and methods.
SUMMARY OF THE INVENTION According to a first aspect of the invention there is provided a fluid resuscitation device comprising: 10- a housing; - a fluid feed line having an inlet which is connectable to a container containing a fluid and an outlet which is connectable to a cannula to administer the fluid to a patient; - a peristaltic pump configured to act on at least a portion of the fluid feed line to transfuse the fluid from the container to the patient via the fluid feed line; 15- temperature regulating means through which the fluid feed line extends and configured to operatively regulate the temperature of the fluid being transfused to the patient; - regulating means for operatively regulating the flow rate and the pressure at which the fluid is transfused to the patient; and - a controller, for controlling the flow rate, pressure and temperature of the fluid being transfused to the patient. There is provided for the temperature regulating means to include a receptacle into which at least a portion of the fluid feed line is receivable. The temperature regulating means may include heating elements, connected to an electrical power source, which are placed proximate the receptacle to heat the fluid in the fluid feed line. There is further provided for the fluid feed line to include a heating arrangement which is receivable into the receptacle of the temperature regulating means. The heating arrangement may include a heat exchanger disposed in a heating compartment, with the heating compartment being shaped and dimensioned to be received into the receptacle. The housing may include a line receiving formation which is configured to receive the portion of the fluid feed line allowing the peristaltic type pump to operatively pump the fluid in the feed line from the container towards the patient.
The fluid may be selected from the group comprising blood products, coagulation agents, anti-coagulation agents, intravenous crystalloids, colloids and other fluids suitable for intravenous transfusion, including pharmaceutical products. The blood products may include whole blood, plasma including fresh frozen plasma (FFP), platelets, packed red blood cells and the like. The intravenous crystalloids may include saline, sodium lactate solutions and glucose solutions. The saline concentration may be 0.9% saline solution, or normal saline. The fluid feed line may be a disposable part. There is provided for the fluid resuscitation device to include at least a first fluid feed line which is connectable to a first container containing a first fluid. There is further provided for a second fluid feed line, having an inlet which is connectable to a second container containing a second fluid. A second pump may be configured to transfuse the second fluid, from the second container to the patient via the fluid feed line. There is further provided for a third fluid feed line, having an inlet which is connectable to a third container containing a third fluid. A third pump may be configured to transfuse the third fluid, from the third container to the patient via the fluid feed line.
The first, second and third fluids may be selected from the group comprising blood products, coagulation agents, anti-coagulation agents, intravenous crystalloids, colloids and other fluids suitable for intravenous transfusion, including pharmaceutical products. The blood products may include whole blood, plasma including fresh frozen plasma (FFP), platelets, packed red blood cells and the like. The intravenous crystalloids may include saline, sodium lactate solutions and glucose solutions. The saline concentration may be 0.9% saline solution, or normal saline. The first-, second- and third pumps may be peristaltic-type pumps.
The container may be a flexible collapsible blood bag or a bag which is specifically designed for use within a fluid resuscitation device. The container may be a high-pressure syringe. The high-pressure syringe may be spring loaded and equipped with an actuator. A spring biased member may urge a plunger of the high-pressure syringe towards a discharged configuration. The high-pressure syringe being configured to discharge its contents under a bias of the spring biased member and upon actuation of the actuator. The fluid resuscitation device may further comprise a flow meter for registering the amount of 5 fluid transfused to the patient. The first, second and third fluid feed lines may be disposable parts. The temperature regulating means may be in thermal communication with the first fluid feed line. The thermal communication between the temperature regulating means and the first fluid feed line may comprise one of conduction; convection; and radiation.
The temperature regulating means may be configured to change the temperature of the fluid to be transfused to one of a calculated temperature and a set temperature.
The temperature regulating means may be configured to ensure that the temperature of the fluid to be discharged will be at a physiologically safe temperature, ranging between 30°C to 42°C.
The temperature regulating means may be configured to ensure that the temperature of the first fluid is raised at a relatively high rate, but remains at a level at which proteins in the first fluid will not denaturise.
The temperature regulating means may be configured to ensure that the temperature of the first fluid remains below 42 degrees Celsius.
The fluid resuscitation device may further comprise at least one sensing means for sensing device parameters, which may be any one of pressure, altitude, fluid quantity, temperature and orientation associated with the fluid resuscitation device.
The sensing means for sensing orientation may comprise an accelerometer.
The fluid resuscitation device may further comprise at least a second sensing means for monitoring essential patient parameters associated with the patient to which the fluid will be transfused.
The essential patient parameters associated with the patient may comprise blood pressure, heartrate, oxygenation levels and core body temperature.
The second sensing means may comprise at least one of: a thermometer for monitoring core body temperature; an electrocardiogram sensor; and a peripheral capillary oxygen saturation sensor. The thermometer may be in the form of an ear thermometer, and the electrocardiogram sensor may be wireless.
The fluid resuscitation device may accommodate a blood filter between the container and the patient. The blood filter may have apertures ranging between 50 to 250 microns in diameter. The controller may be in communication with a user input means, the first- and second sensing means and the electrical loads of the device.
The user input means may be configured to allow a user to send instructions to the controller The user input means may comprise any of a keyboard, a screen, a touch screen or any other user input devices known in the art.
The controller may be connected to the flow meter and may utilise data received from the flow meter to control the quantity of fluid being transfused to the patient.
The controller may also be capable of controlling a flow rate of the fluid during administration of the fluid to the patient.
The resuscitation device may be capable of administering the first fluid at a flow rate between 0,1ml/s and 5ml/s.
The controller may also be capable of controlling the pressure of the fluid during administration of the fluid to the patient.
The resuscitation device may be capable of transfusing the first fluid within a range of 1 to 5 kpa.
The controller may be configured to receive data from the pressure sensor, and the temperature sensor.
The controller may be capable of changing parameters of power supplied to a motor of the pump in order to change the pressure and the flow rate of the fluid being transfused to the patient. The controller may be configured to calculate the pressure and the flow rate at which the fluid is transfused to the patient.
The controller may be configured to actuate the actuator. The housing may define at least a first compartment for accommodating the container with some fluid contained in the container.
The first compartment may be thermally insulated. The first compartment may be provided with a second temperature sensor and a second temperature regulating means for maintaining the first fluid at a desired temperature. The second temperature sensor and regulating means may be in communication with the controller.
The first compartment may be a pressure tight sealable compartment. There is also provided for a compressed gas container and a gas regulating means for regulating the amount of gas departing the compressed gas container.
The compressed gas container and the gas regulating means may be carried by the housing. A gas within the compressed gas container may be used to provide additional pressure to the fluid being transfused to the patient.
The gas may be conveyed from the compressed gas cylinder to the compartment within which the container containing the first fluid is situated. The gas may exert a uniform pressure on a surface of the container containing the first fluid.
The controller may be configured to control the gas regulating means. The fluid resuscitation device may further comprise a first receiver of a satellite-based navigation system configured to receive a signal transmitted from a satellite in the Global Navigation Satellite System network and to generate location data. The first receiver may be in communication with the controller.
There is further provided for a remote monitoring station and a wireless receiver in communication with the controller. The wireless receiver may be configured to receive signals via a first wireless communication path utilising GSM or any other suitable communication protocol or standard, from the remote monitoring station. The wireless receiver may form part of a transceiver. The transceiver may transmit data associated with the fluid resuscitation device via the wireless communication path utilising GSM or any other suitable communication protocol or standard, for reception by the remote monitoring station. There is provided for an electrical power source, which may comprise a power electronic circuit and a rechargeable battery. The power electronic circuit may be supplied with power by the rechargeable battery or by an external power source. The power electronic circuit may have multiple power outputs, which outputs may each supply an electrical load at a pre- determined voltage. There is further provided for an electrical charging circuit for charging the rechargeable battery. The electrical charging circuit may utilise AC power from an external source to charge the rechargeable battery or DC power from an external source, such as a photo voltaic source.
BRIEF DESCRIPTION OF THE ACCOMPANYING DIAGRAMS The present invention will now further be described, by way of example only, with reference to the accompanying diagrams wherein: Figure 1 is a first diagram illustrating the functionality of the fluid resuscitation device; Figure 2 is a diagram illustrating the functionality of the fluid resuscitation device; Figure 3 is a diagrammatic perspective view of an example embodiment of a fluid resuscitation device from a first angle; Figure 4 is a schematic representation of an alternative example embodiment of a fluid resuscitation device; Figure 5 is a further schematic representation of the example embodiment of figure 4; and
Figure 6 is a schematic representation of the example embodiment of figures 4 and 5 in use.
DETAILED DESCRIPTION OF THE INVENTION A fluid resuscitation device is generally represented by reference numeral 10 in the accompanying diagrams. Figures 1 and 2 are diagrammatic illustrations of the fluid resuscitation device 10. The fluid resuscitation device 10 comprises a housing 12, peristaltic pump(s) 20, (and 22, 24 in figure 2), an electrical power source (not shown), flow meter(s) 30, (and 32, 34 in figure 2), pressure sensor(s} 40, (and 42, 44 in figure 2), 50, (and 52, 54 in figure 2), temperature sensor(s) 60, (and 62, 64 in figure 2), 70, (and 72, 74 in figure 2), temperature regulating means 80, {and 82, 84 in figure 2}, 90, (and 92, 94 in figure 2) and fluid feed line(s) 100, {and 102, 104 in figure 2), through which fluid are transfused to a patient (not shown). The housing 12 has a first compartment 110, (and second- and third compartment 112, 114 in figure 2) for receiving a first container 120, (and second and third container 122, 124 in figure 2) respectively. The compartment(s) 110, (and 112, 114 in figure 2) are pressure tight sealable compartment(s). Each container 120, (and 122, 124 in figure 2) contains a different type of fluid. The first container 120 typically contains blood, the second container 122 typically contains saline and the third container 124 typically contains medication. The housing 12 carries pressurised gas container(s) 130, (and 132, 134 in figure 2), which each has a valve 140, (and 142, 144 in figure 2) connected to thereto. The housing also carries a controller 150.
The controller 150 is connected to and receives data from the peristaltic pump(s) 20, (and 22, 24, in figure 2) flow meter(s) 30, (and 32, 34 in figure 2) pressure sensors 40, (and 42, 44 in figure 2), 50, (and 52, 54 in figure 2) temperature sensors 60, (and 62, 64, in figure 2) 70, (and 72, 74 in figure 2), temperature regulating means 80, (and 82, 84, in figure 2) 90, (and 92, 94 in figure 2), valve(s) 140, (and 142, 144 in figure 2), an accelerometer 152, a GPS receiver 154, a patient parameter sensor 156, a GSM or WiFi module 158 and a user input means 160. The controller 150 controls the peristaltic pump(s) 20, (22, 24 in figure 2) temperature regulating means 80, (and 82, 84 in figure 2), 90, (and 92, 94 in figure 2) and valve(s) 140, (and 142, 144 in figure 2) based on the received data.
The controller 150 utilises the data received from temperature sensor(s) 70, (and 72, 74 in figure 2) to control the temperature regulating means 90, (and 92, 94 in figure 2) so that the temperature of the fluid(s) within the container(s) 120, (and 122, 124 in figure 2) are maintained at a temperature specified by the user.
During use of the fluid resuscitation device 10 the user specifies quantities (by using the user input means 160) of fluid which must be transfused to the patient as well as the rate at which administration must be executed. The controller 150 then sends instruction signals to the peristaltic pump(s) 20, (and 22, 24 in figure 2) and valves 140, (and 142, 144 in figure 2) to operate.
The valves 140, (and 142, 144 in figure 2) operate by allowing compressed gas from the compressed gas cylinder(s) 130, (132, 134 in figure 2) to flow from the compressed gas cylinders. the compressed gas is then channelled to the compartment(s) 110, (and 112, 114 in figure 2) resulting in an increase in pressure within the compartment(s) 110, (and 112, 114 in figure 2). The gas inside the compartment(s) 110, (and 112, 114 in figure 2) exert a uniform pressure on the container(s) 120, (and 122, 124 in figure 2) to prevent the container(s) 120, (and 122, 124 in figure 2) from bursting or rupturing. The increase in pressure causes the fluids within the container(s) 120, (and 122, 124 in figure 2) to flow from the container(s) 120, (and 122, 124 in figure 2) via tubes which connects the container(s) 120 (and 122, 124 in figure 2) to the fluid feed line(s) 100, (and 102, 104 in figure 2). The fluid(s) are then pumped by the peristaltic pump(s) 20, (and 22, 24 in figure 2) via the fluid feed line(s) 100, (and 102, 104 in figure 2} to a patient (not shown). The fluid feed line(s) 100, (and 102, 104 in figure 2) comprise the flow meter(s) 30, (and 32 34 in figure 2), pressure sensor(s) 40, (and 42, 44 in figure 2) temperature sensor(s) 60, (and 82, 64 in figure 2) and temperature regulating means 80, (and 82, 84 in figure 2) respectively.
When the fluid(s) flow(s) through the fluid feed line(s) 100, (and 102, 104 in figure 2) the flow meter(s} 30, (and 32, 34 in figure 2) register(s) the quantity of fluid transfused to the patient. Once a specified quantity of fluid is transfused to the patient, the controller 150 stops the flow of fluid by sending appropriate signals to the peristaltic pump(s) 20, (and 22, 24 in figure 2) and valve(s) 140, (and 142, 144 in figure 2).
The pressure sensor(s) 40, (and 42, 44 in figure 2) register(s) the pressure of the fluid being transfused to the patient. If a pressure measured by the pressure sensor(s) 40, (and 42, 44 in figure 2) is too low or too high the controller 150 sends the appropriate signals to the peristaltic pump(s) 20, (and 22, 24 in figure 2) and valve(s) 140, (and 142, 144 in figure 2) to increase or decrease the pressure of the fluid.
The temperature sensor(s) 60, (and 62, 64 in figure 2) register(s) a temperature of the fluid being transfused to the patient. If the temperature is below or above a specified value, the controller 150 sends the appropriate signals to the temperature regulating means 80, (and 82, 84 in figure 2) to regulate the temperature(s) of the fluid(s) by increasing or decreasing the temperature(s) of the fluid(s). The accelerometer 152 provides data to the controller 150 regarding the orientation of, and accelerations which, the fluid resuscitation device 10, is subjected to. The controller 150 is capable of using the data provided by the accelerometer 152 in order to determine, whether it is safe for the fluid resuscitation device 10 to administer fluid(s) to the patient. The GSM or WiFi module 158 also allows for data to be exchanged between the controller 150 and the remote monitoring station via a wireless communication path. The user of the fluid resuscitation device 10 is therefore able to specify the quantity of fluid which must be transfused to the patient as well as the rate at which administration must be executed from the remote monitoring station. The GPS receiver 154 provides data relating to the position of the fluid resuscitation device
10. The fluid resuscitation device 10 is capable of sending the data received by the GPS receiver 154 via the wireless communication path to the remote monitoring station. The patient parameter sensor 158 provides data associated with the patient to the controller
150. The data associated with the patient includes the oxygen saturation levels, heart rate, blood pressure and temperature of the patient. The data associated with the patient is utilised by the controller 150 to determine when the peristaltic pump(s) 20, (and 22, 24 in figure 2) and the valve(s) 140, (and 142, 144 in figure 2) are to be switched on and to control the amount of power provided to the peristaltic pump(s) 20, (and 22, 24 in figure 2) and the valve(s) 140, (and 142, 144 in figure 2). Figure 3 is a diagrammatic perspective view of an example embodiment of a fluid resuscitation device 10.. Figure 3 shows the housing 12 with the compartments 110, 112, 114, the compressed gas containers 130, 132, 134, the valves 140, 142, 144 and the user input means 160. A container 124 containing fluid can be inserted into any one of the compartments 110, 112, 114.
Figures 4 to 6 are schematic representations of an alternative embodiment of the fluid resuscitation device described hereinabove.
Housing 170 houses a peristaltic pump 178 and fluid heating elements 186 adjacent to a receptacle 184. Fluids, typically whole blood or blood products, are contained within container 172, with fluid line 174 extending from it.
Fluid line 174 is engaged with the peristaltic pump by placing fluid line 174 into a line receiving formation 176, from where peristaltic pump 178 pumps fluid through fluid line 174 into a heat exchanger 182, disposed within the fluid heating compartment 180. Fluid heating compartment 180 is then placed into complementary shaped receptacle 184, wherein the fluid heating elements 186 transfer heat to a fluid in the fluid heating compartment 180 increasing the temperature of the fluid, which in turn causes an increase the temperature of the fluid inside heat exchanger 182 to a predetermined level.
The peristaltic pump 178 is calibrated such that the fluid is pumped at a velocity or flow rate which allows the fluid to flow through the heat exchanger 182 at a predetermined rate to allow sufficient exposure of the fluid to heating element 186, before being pumped from the heat exchanger 182 into fluid line 190 and towards canula 192 for administration to a patient 194. The flow rate is foreseen to be between 0,1ml/s and 5ml/s, with pressure of the fluid infused to the patient not exceeding 4,5kPa so as to prevent rupturing of fluid lines of the device, or cause damage to the patient by rupturing arteries or veins.
Fluid container 172, fluid line 174, heating compartment 180, heat exchanger 182, fluid line 190 and canula 192 (collectively referred to as disposable fluid administration unit 200) is provided as a separate sterile unit which can be connected to the housing 170 in such a way that the peristaltic pump 176 pumps the fluid from the container 172 via the heat exchanger 182 and into the fluid line 190 for administration such that fluids never come into contact with the fluid resuscitation device, and hence the fluid administration unit can be removed from the fluid resuscitation device and discarded as per requirements for medical waste disposal, which obviates the need for sterilisation of the fluid resuscitation device between different patients.
It will be understood that all of the other components referred to in the first example embodiment, including but not limited to the controller, temperature and pressure sensors, patient parameter sensors, GPS receiver, GSM or Wifi communication module, electrical power source and all other related parts will also be provided in fluid resuscitation device 196 as described in this alternative embodiment of the second embodiment.
The disadvantages experienced with the prior approaches to fluid resuscitation is accordingly overcome by providing a fluid resuscitation device that can provide appropriately heated fluid at increased flow velocity and pressure so as to rapidly infuse fluid into a patient in a controlled and measured fashion, which would drastically halt the effects of hypovolaemic shock, and increase the chances of survival of the patient. It would also allow medical practitioners the ability to reliably infuse fluids at the optimal fluid velocity and pressure so as to increase the odds of survival of trauma and other patients requiring resuscitation.
It will be appreciated by those skilled in the art that the invention is not limited to the precise details as described herein and that many variations are possible without departing from the scope and spirit of the invention.
The description is presented in the cause of providing what is believed to be the most useful and readily understandable description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show and/or describe structural details of the invention in more detail than is necessary for a fundamental understanding of the invention. The words used should therefore be interpreted as words of description rather than words of limitation.

Claims (1)

-14 --14 - CONCLUSIESCONCLUSIONS 1. Inrichting voor het toedienen van fluidum, omvattende: - een behuizing; - een fluidumtoevoerleiding met een inlaat die kan worden verbonden met een houder die een fluïdum bevat en een uitlaat die kan worden aangesloten op een canule om hrt fluïdum aan een patiënt toe te dienen; - een pomp die is geconfigureerd om in te werken op ten minste een deel van de fluidumtoevoerleiding om het fluïdum van de houder naar de patiënt over te brengen via de fluidumtoevoerleiding; - een temperatuurregelmiddel waardoorheen de fluidumtoevoerleiding zich uitstrekt, die is geconfigureerd om de temperatuur van het naar de patiënt overgebrachte fluidum werkzaam te regelen; - regelmiddelen voor het werkzaam regelen van het debiet en de druk waarmee de fluïdum naar de patiënt wordt overgebracht; en - een regelaar voor het regelen van het debiet en de temperatuur van het fluïdum dat naar de patiënt wordt overgebracht.A device for administering fluid, comprising: - a housing; a fluid supply line having an inlet connectable to a container containing a fluid and an outlet connectable to a cannula for delivering the fluid to a patient; - a pump configured to act on at least a portion of the fluid supply line to transfer the fluid from the container to the patient through the fluid supply line; a temperature control means through which the fluid supply conduit extends, configured to operatively control the temperature of the fluid transferred to the patient; - control means for operatively controlling the flow rate and the pressure with which the fluid is transferred to the patient; and - a controller for controlling the flow rate and temperature of the fluid transferred to the patient. 2. Toedieningsinrichting volgens conclusie 1, waarbij het temperatuurregelmiddel een verwarmingshouder en verwarmingselementen omvat die zich nabij de houder bevinden en geconfigureerd zijn om de temperatuur te regelen van het fluidum dat wordt overgebracht vanuit de houder naar de patiënt.The administration device of claim 1, wherein the temperature control means comprises a heating container and heating elements located adjacent the container and configured to control the temperature of the fluid transferred from the container to the patient. 3. Toedieningsinrichting volgens conclusie 2, waarbij de fluidumtoevoerleiding een verwarmingsopstelling omvat in de vorm van een warmtewisselaar die kan worden opgenomen in de verwarmingshouder, waarbij de verwarmingselementen zijn geconfigureerd om de temperatuur van het fluidum dat door de warmtewisselaar stroomt, werkzaam te regelen.The dispensing device of claim 2, wherein the fluid supply conduit includes a heating arrangement in the form of a heat exchanger that may be received in the heating container, the heating elements configured to operatively control the temperature of the fluid flowing through the heat exchanger. 4. Toedieningsinrichting volgens een van de voorgaande conclusies, waarbij de behuizing een toevoerleiding opnemende formatie omvat. die zich dichtbij de pomp van het peristaltische type bevindt.A delivery device according to any one of the preceding claims, wherein the housing comprises a supply conduit receiving formation. which is close to the peristaltic type pump. 5. Toedieningsinrichting volgens conclusie 4, waarbij de toevoerleiding opnemende formatie is geconfigureerd om de fluidumtoevoerleiding op te nemen waarbij de peristaltische pomp werkzaam is om de toevoerleiding samen te drukken en te ontspannen die de fluidum van de houder naar de patiënt pompt.The administration device of claim 4, wherein the supply conduit receiving formation is configured to receive the fluid supply conduit wherein the peristaltic pump is operable to compress and relax the supply conduit which pumps the fluid from the container to the patient. -15--15- 8. Toedieningsinrichting volgens conclusie 1, waarbij de fluidumtoevoerleiding de vorm heeft van een eerste fluidumtoevoerleiding en de houder de vorm heeft van een eerste houder die een eerste fluidum bevat.The administering device of claim 1, wherein the fluid supply conduit is in the form of a first fluid supply conduit and the container is in the form of a first container containing a first fluid. 7. Toedieningsinrichting volgens conclusie 6, waarbij de fluidumtoevoerleiding, pomp, temperatuurregelmiddel zich binnen de behuizing bevinden.The dispensing device of claim 6, wherein the fluid supply line, pump, temperature control means are located within the housing. 8. Toedieningsinrichting volgens conclusie 7, die een tweede fluidumtoevoerleiding omvat die kan worden verbonden met een tweede houder die een tweede fluidum bevat.The administering device of claim 7, comprising a second fluid supply conduit connectable to a second container containing a second fluid. 9. Toedieningsinrichting volgens conclusie 8, die een tweede pomp omvat die is geconfigureerd om het tweede fluidum van de tweede houder naar de patiént over te brengen.The delivery device of claim 8, comprising a second pump configured to transfer the second fluid from the second container to the patient. 10. Toedieningsinrichting volgens conclusie 9, die een derde fluidumtoevoerleiding omvat die kan worden verbonden met een derde houder die een derde fluidum bevat.The administering device of claim 9, comprising a third fluid supply conduit connectable to a third container containing a third fluid. 11. Toedieningsinrichting volgens conclusie 10, die een derde pomp omvat die is geconfigureerd om het derde fluidum van de derde houder naar de patiént over te brengen.The delivery device of claim 10, comprising a third pump configured to transfer the third fluid from the third container to the patient. 12. Toedieningsinrichting volgens een van de voorgaande conclusies, waarbij het fluidum is gekozen uit de groep bestaande uit bloedproducten, stollingsmiddelen, antistollingsmiddelen, intraveneuze kristalloiden, colloiden en voor intraveneuze transfusie geschikte fluida, waaronder farmaceutische producten.A delivery device according to any one of the preceding claims, wherein the fluid is selected from the group consisting of blood products, coagulants, anticoagulants, intravenous crystalloids, colloids and intravenous transfused fluids, including pharmaceuticals. 13. Toedieningsinrichting volgens conclusie 12, waarbij de bloedproducten volbloed, plasma inclusief vers ingevroren plasma (FFP), bloedplaatjes, verpakte rode bloedcellen en dergelijke omvatten.The delivery device of claim 12, wherein the blood products comprise whole blood, plasma including fresh frozen plasma (FFP), platelets, packaged red blood cells and the like. 14. Toedieningsinrichting volgens conclusie 12, waarbij de intraveneuze kristalloiden zoutoplossing, natriumlactaatoplossingen en glucoseoplossingen kunnen omvatten.The delivery device of claim 12, wherein the intravenous crystalloids may comprise saline, sodium lactate solutions, and glucose solutions. 15. Toedieningsinrichting volgens conclusie 14, waarbij de concentratie van de zoutoplossing een 0,9% zoutoplossing of normale zoutoplossing is.The delivery device of claim 14, wherein the concentration of the saline is 0.9% saline or normal saline. 16. Toedieningsinrichting volgens een van de voorgaande conclusies, waarbij de houder een flexibele opvouwbare zak is.A delivery device according to any one of the preceding claims, wherein the container is a flexible collapsible pouch. -16 --16 - 17. Toedieningsinrichting volgens een van de voorgaande conclusies, waarbij de houder een hogedruk injectiespuit is die veerbelast is en is voorzien van een actuator.A dispensing device according to any one of the preceding claims, wherein the container is a high pressure syringe which is spring loaded and includes an actuator. 18. Toedieningsinrichting volgens conclusie 17, waarbij de hogedruk injectiespuit is geconfigureerd om de inhoud ervan af te geven onder een voorspanning van een veerbelast orgaan en bij activering van de actuator.The delivery device of claim 17, wherein the high pressure syringe is configured to deliver its contents under a bias from a spring loaded member and upon actuation of the actuator. 19. Toedieningsinrichting volgens een van de voorgaande conclusies, die een stromingsmeter omvat, in fluidumverbinding met de fluidumtoevoerleiding, voor het registreren van de hoeveelheid naar de patiënt overgebracht fluïdum.A delivery device according to any one of the preceding claims, comprising a flow meter, in fluid communication with the fluid supply line, for sensing the amount of fluid transferred to the patient. 20. Toedieningsinrichting volgens een van de voorgaande conclusies, waarbij het temperatuurregelmiddel is geconfigureerd om ervoor te zorgen dat de temperatuur van het naar de patiënt over te brengen fluidum een fysiologisch veilige temperatuur is, in het bereik van 30 °C tot 42 °C.The administration device of any preceding claim, wherein the temperature control means is configured to ensure that the temperature of the fluid to be transferred to the patient is a physiologically safe temperature, in the range of 30°C to 42°C. 21. Toedieningsinrichting volgens een van de voorgaande conclusies, die aftastmiddelen omvat voor het aftasten van inrichtingsparameters waaronder druk, hoogte, fluidumhoeveelheid, temperatuur en oriëntatie behorende bij de fluidumtoedieningsinrichting.A dispensing device according to any one of the preceding claims, comprising sensing means for sensing device parameters including pressure, elevation, fluid amount, temperature and orientation associated with the fluid dispensing device. 22. Toedieningsinrichting volgens conclusie 21, die tweede aftastmiddelen omvat voor het bewaken van essentiële patiëntparameters die verband houden met de patiënt waarnaar het fluidum zal worden overgebracht, die bloeddruk, hartslag, zuurstofniveaus en kerntemperatuur van het lichaam omvatten.The delivery device of claim 21, comprising second sensing means for monitoring essential patient parameters associated with the patient to which the fluid is to be transferred, including blood pressure, heart rate, oxygen levels and core body temperature. 23. Toedieningsinrichting volgens conclusie 22, waarbij de tweede aftastmiddelen ten minste één omvatten van: een thermometer voor het bewaken van de kerntemperatuur van het lichaam; een elektrocardiogramsensor; en een perifere capillaire zuurstofverzadigingssensor.The administering device of claim 22, wherein the second sensing means comprises at least one of: a thermometer for monitoring core body temperature; an electrocardiogram sensor; and a peripheral capillary oxygen saturation sensor. 24. Toedieningsinrichting volgens een van de voorgaande conclusies, die een bloedfilter omvat dat zich tussen de houder en de patiënt bevindt.A delivery device according to any one of the preceding claims, comprising a blood filter located between the container and the patient. 25. Toedieningsinrichting volgens conclusie 25, waarbij de regelaar in verbinding staat met de eerste aftastmiddelen, de tweede afstandsmiddelen en een gebruikersinvoermiddel.The administering device of claim 25, wherein the controller communicates with the first sensing means, the second remote means and a user input means. 26. Toedieningsinrichting volgens conclusie 25, waarbij de regelaar is verbonden met de stromingsmeter en is geconfigureerd om gegevens te gebruiken die worden ontvangenThe delivery device of claim 25, wherein the controller is connected to the flow meter and configured to use data it receives -17 - van de stromingsmeter om de hoeveelheid en snelheid van het fluidum dat wordt overgebracht naar de patiént te regelen.-17 - of the flow meter to control the amount and rate of fluid transferred to the patient. 27. Toedieningsinrichting volgens conclusie 26, waarbij de regelaar is geconfigureerd om de parameters van het aan een motor van de pomp geleverde vermogen te veranderen om de druk en het debiet van het naar de patiént overgebrachte fluidum te veranderen.The delivery device of claim 26, wherein the controller is configured to alter the parameters of the power supplied to a motor of the pump to alter the pressure and flow rate of the fluid transferred to the patient. 28. Toedieningsinrichting volgens een van de voorgaande conclusies, waarbij de behuizing ten minste een eerste compartiment definieert voor het opnemen van de houder die het fluidum bevat.A delivery device according to any one of the preceding claims, wherein the housing defines at least a first compartment for receiving the container containing the fluid. 29. Toedieningsinrichting volgens conclusie 28, waarbij het eerste compartiment thermisch geïsoleerd is en een tweede temperatuursensor en een tweede temperatuurregelmiddel omvat om het eerste fluïdum op de gewenste temperatuur te houden.The delivery device of claim 28, wherein the first compartment is thermally insulated and comprises a second temperature sensor and a second temperature control means for maintaining the first fluid at the desired temperature. 30. Toedieningsinrichting volgens conclusie 28, waarbij het eerste compartiment een drukdicht afsluitbaar compartiment is met een houder voor gecomprimeerd gas en gasregelmiddelen in verbinding met het eerste compartiment.A dispensing device according to claim 28, wherein the first compartment is a pressure-tight sealable compartment having a compressed gas container and gas control means in communication with the first compartment. 31. Toedieningsinrichting volgens conclusie 30, waarbij gas wordt getransporteerd van de houder voor gecomprimeerd gas naar het eerste compartiment om aanvullende druk te geven aan de houder en het fluïdum dat wordt overgebracht naar de patiënt.The delivery device of claim 30, wherein gas is conveyed from the compressed gas container to the first compartment to provide supplemental pressure to the container and the fluid being transferred to the patient. 32. Toedieningsinrichting volgens een van de voorgaande conclusies, die een eerste ontvanger van een op satellieten gebaseerd navigatiesysteem omvat, die is geconfigureerd om een signaal te ontvangen dat wordt uitgezonden vanaf een satelliet in een Global Navigation Satellite System-netwerk en om locatiegegevens te genereren.A delivery device according to any preceding claim, comprising a first satellite-based navigation system receiver configured to receive a signal broadcast from a satellite in a Global Navigation Satellite System network and to generate location data. 33. Toedieningsinrichting volgens een van de voorgaande conclusies, die een zendontvanger omvat die is geconfigureerd om gegevens te verzenden die verband houden met de fluidumtoedieningsinrichting via het draadloze communicatiepad dat GSM gebruikt voor ontvangst door een op afstand gelegen bewakingsstation.A delivery device according to any one of the preceding claims, comprising a transceiver configured to transmit data related to the fluid delivery device over the wireless communication path using GSM for reception by a remote monitoring station. 34. Toedieningsinrichting volgens een van de voorgaande conclusies, die een elektrische voedingsbron omvat die een vermogenselektronisch circuit en een oplaadbare batterij omvat, waarbij het vermogenselektronische circuit wordt gevoed door de oplaadbare batterij of een externe voedingsbron.A delivery device according to any one of the preceding claims, comprising an electrical power source comprising a power electronic circuit and a rechargeable battery, wherein the power electronic circuit is powered by the rechargeable battery or an external power source.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4678460A (en) * 1985-02-11 1987-07-07 Rosner Mark S Portable rapid massive parenteral fluid warming and infusion apparatus
US20130197437A1 (en) * 2012-01-20 2013-08-01 Medical Solutions, Inc. Method and Apparatus for Controlling Temperature of Medical Liquids
WO2018144951A1 (en) * 2017-02-02 2018-08-09 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4678460A (en) * 1985-02-11 1987-07-07 Rosner Mark S Portable rapid massive parenteral fluid warming and infusion apparatus
US20130197437A1 (en) * 2012-01-20 2013-08-01 Medical Solutions, Inc. Method and Apparatus for Controlling Temperature of Medical Liquids
WO2018144951A1 (en) * 2017-02-02 2018-08-09 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control

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