WO2020208532A1 - Appareil pour dialyse péritonéale - Google Patents

Appareil pour dialyse péritonéale Download PDF

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Publication number
WO2020208532A1
WO2020208532A1 PCT/IB2020/053332 IB2020053332W WO2020208532A1 WO 2020208532 A1 WO2020208532 A1 WO 2020208532A1 IB 2020053332 W IB2020053332 W IB 2020053332W WO 2020208532 A1 WO2020208532 A1 WO 2020208532A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
medical apparatus
conduit
cassette
fluid conduit
Prior art date
Application number
PCT/IB2020/053332
Other languages
English (en)
Inventor
Toh Chen HOU
Original Assignee
Lucenxia Ltd
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
Priority claimed from AU2019903777A external-priority patent/AU2019903777A0/en
Application filed by Lucenxia Ltd filed Critical Lucenxia Ltd
Priority to BR112021020210A priority Critical patent/BR112021020210A2/pt
Priority to JP2021560615A priority patent/JP2022527717A/ja
Priority to CN202080027159.6A priority patent/CN113825532A/zh
Publication of WO2020208532A1 publication Critical patent/WO2020208532A1/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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/281—Instillation other than by gravity
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/153—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
    • A61M1/1561—Constructional details of the cassette, e.g. specific details on material or shape at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
    • A61M1/1562—Details of incorporated reservoirs
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
    • A61M1/1565—Details of 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/159—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit specially adapted for peritoneal dialysis
    • 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
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/127—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • 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
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling

Definitions

  • the present disclosure relates to a medical apparatus, such as an apparatus for use in treating end stage renal disease, and in particular an improved automated peritoneal dialysis (APD) apparatus.
  • a medical apparatus such as an apparatus for use in treating end stage renal disease, and in particular an improved automated peritoneal dialysis (APD) apparatus.
  • APD automated peritoneal dialysis
  • the present disclosure also relates to associated control systems and methods.
  • Dialysis is used to support a patient with end stage renal disease where the kidneys no longer function to remove waste products, toxins and excessive water from the blood.
  • a common form of dialysis is haemodialysis.
  • Peritoneal dialysis (PD) is a form of dialysis used to treat patients with kidney failure.
  • Peritoneal dialysis uses the peritoneum in a patient’s abdomen as the membrane though which fluid and dissolved substances are exchanged with the patient’s blood. Peritoneal dialysis can be beneficial over haemodialysis in some situations, such as allowing greater flexibility for patients, potentially improved outcomes in the first few years of use and potentially improved tolerability for patients with heart disease.
  • Peritoneal dialysis may take place at regular intervals through the day, in a process commonly known as continuous ambulatory peritoneal dialysis (CAPD).
  • CCAPD continuous ambulatory peritoneal dialysis
  • APD automated peritoneal dialysis
  • the APD machine may be used on a patient through the night while the patient is asleep.
  • Automated Peritoneal dialysis comprises: a cycler (the automated peritoneal dialysis machine); dialysate fluid (typically a sterile aqueous dextrose solution with some essential minerals); and consumables, including a cassette and drainage bag.
  • a catheter Before a patient can undertake PD treatment, a catheter must be inserted into the patient’s abdominal cavity, specifically the peritoneum, via a surgical procedure.
  • the cycler delivers dialysate into patient’s peritoneum in an infusion process. If necessary, medication can be included with the fluid before infusion.
  • the dialysate fluid remains in the abdomen of the patient and waste products, including solutes, toxins and excessive water, are absorbed into the fluid via diffusion and osmosis across a concentration gradient.
  • the cycler will then remove the effluent/waste from the patient’s body.
  • This cycle of infusion, diffusion and drainage can be according to a set program. During an overnight program, the cycler can go through 3 to 10 fill-dwell-drain cycles per night. A physician may oversee the process to decide when sufficient cycles are completed and the patient has clearance.
  • the cycler will pre-warm the dialysate to a desired temperature (close to human body temperature) before infusing the fluid into the patient. This warming of the fluid can prevent potential temperature shock in the patient that can be caused when cold fluid is infused.
  • a cassette will be used as the device which controls the flow of dialysate fluid and effluent in the infusion and drainage processes.
  • some conventional APD cyclers will measure the initial weight of the drainage bag, such as by using a load cell. The weight of this bag will be monitored throughout the process of effluent draining. The cycler will stop draining when the measured weight of the bag corresponds to a desired target volume. This manner of calculating the volume drained from a patient may not be as accurate as desired, for example by measuring weight there may be differences between the calculated and actual volumes.
  • Other conventional APD cyclers may estimate the drainage volume through a calculation involving the number of pump strokes of drainage according to the fixed shape and volume of the cycler’s cassette. For an example, if 20 ml of effluent is pumped out for each stroke on average, then 100 strokes of pumps will drain 2000 ml of effluent. This calculation method may not be as accurate as desired, i.e. the volume calculated may not match the actual volume. A reason for this inaccuracy may be that the pumping stroke is dependent on: (i) air pressure that drives the pumping action; (ii) the stiffness of the elastic membrane and the operating temperature of the membrane which will vary the stiffness of any polymer membrane.
  • dialysate to be heated In order to warm the dialysate to a desired temperature, some conventional APD cyclers will have an external heater to warm a whole bag of dialysate. This bag to be heated is commonly known as a heating bag. Dialysate to be used will be pumped into the heating bag to be warmed until a desired temperature is reached. Once at the desired temperature, the dialysate can be delivered to the patient’s body. A period of time, generally a few minutes, must elapse for the bag of dialysate to be heated before the cycler can begin infusing dialysate to a patient. This method of heating may be more time consuming than desired and due to heating an entire bag of fluid before use the method may also be less energy efficient than is desirable.
  • APD cyclers may warm the dialysate using an internal heater in the cycler.
  • the cassette may contain a number of heating lines/channels.
  • the dialysate will be pumped into the cycler through the cassette and the internal heater will warm the dialysate while it flows through the heating channels before delivery to a patient.
  • This method of heating may not allow the temperature of the fluid to be controlled as desired because the fluid passes through the channels for a set period of time.
  • the only way to control the temperature in these systems would be to increase the heat of the heater, which would cause an increase in the energy consumption of the machine as well as a higher variance in the delivered temperature.
  • APD cyclers may utilise mechanical actuators to physically open and close gates/valves to the various channels in the cassette.
  • the flow can be controlled by mechanical manipulation of the correct gates/valves into the open or closed positions using the actuators.
  • the use of mechanical actuators in conventional systems may be more complex and use more parts than is desirable.
  • Conventional APD cyclers may include a single pump to move the dialysate to a patient.
  • the single pump will generate a single fixed positive pressure to pump the dialysate into the patient during the fill process.
  • these cyclers will use the force of gravity to drain effluent from the patient.
  • the single pump and drainage using gravity can place limitations on the placement, such as requiring the machine to be placed at a certain height, which may be undesirable.
  • APD cyclers may move the dialysate and effluent in or out of the patient using two separate pumps.
  • One pump is used to generate positive pressure to move dialysate into the patient and the other generates negative pressure or a vacuum to withdraw effluent from the patient.
  • the pressure of each pump is fixed. The use of two pumps may make the APD machine bulky, heavy, more costly and less energy efficient than is desirable.
  • APD peritoneal dialysis
  • a medical apparatus comprising: a housing; a cassette adapted to be received in a receiving region of the housing, the cassette including at least one membrane; at least one gas conduit; and a pressure source; wherein the at least one membrane is in fluid communication with at least one of the at least one gas conduit, and wherein the pressure source is adapted to apply a positive and/or negative pressure through the at least one gas conduit to control a movement of the at least one membrane.
  • the present invention provides a medical apparatus, comprising: a fluid conduit; a ultrasound sensor positioned adjacent to the fluid conduit and adapted to emit and detect soundwaves through the fluid conduit; and a means for pumping a fluid through the fluid conduit, wherein the ultrasound sensor is adapted to detect a flow rate of the fluid passing through the fluid conduit to be used to calculate a volume of fluid that is pumped through the fluid conduit, wherein the medical apparatus is an automated peritoneal dialysis (APD) machine.
  • APD automated peritoneal dialysis
  • a medical apparatus wherein the medical apparatus is preferably an automated peritoneal dialysis (APD) machine, the medical apparatus comprising: a housing; a cassette adapted to be received in a receiving region of the housing, the cassette including at least one membrane; at least one gas conduit; and a pressure source; wherein the at least one membrane is in fluid communication with at least one of the at least one gas conduit, wherein the pressure source is adapted to apply a positive and/or negative pressure through the at least one gas conduit to control a movement of the at least one membrane, and wherein the cassette includes an internal cavity adapted to receive a fluid, wherein the internal cavity is bordered on at least one side by a membrane of the at least one membranes, and wherein the application of positive and/or negative pressure to said membrane causes the fluid to move into or out of the internal cavity.
  • APD automated peritoneal dialysis
  • the movement of the at least one membrane is towards or away from an opening of the at least one gas conduit, depending on whether the pressure applied is positive or negative.
  • the medical apparatus may further comprise a fluid gate having an open position and a closed position.
  • the movement of the membrane towards or away from the gas conduit may determine whether the fluid gate is in the open position or the closed position.
  • the medical apparatus comprises a plurality of the gas conduits, a plurality of the membranes and a plurality of the gates.
  • Each of the gates may have a respective open position and a respective closed position, and the application of the positive and/or negative pressure may control a respective movement of the membranes to determine which of said gates are in said respective open and closed position.
  • each conduit includes a valve which is adapted to determine whether the pressure source can apply the positive and/or negative pressure through said conduit to the respective membrane.
  • the medical apparatus may comprises at least one first gate to control a flow of a fluid from a fluid source; a second gate to control a flow of the fluid to a patient and a third gate to control a flow of a fluid to a drain or receptacle.
  • the cassette comprises said gate or gates.
  • the cassette includes an internal cavity adapted to receive a fluid.
  • the internal cavity may be bordered on at least one side by a membrane of the at least one membranes. The application of positive and/or negative pressure to said membrane may cause the fluid to move into or out of the internal cavity.
  • the medical apparatus may further comprise: at least one first fluid conduit adapted to transfer a first fluid from a fluid source to the internal cavity of the cassette; a second fluid conduit adapted to transfer the first fluid from the internal cavity to a patient and/or a second fluid from a patient to the internal cavity; and a third fluid conduit adapted to transfer the second fluid from the internal cavity to a drain or receptacle.
  • the at least one first gate is adapted to control the flow of the first fluid through the at least one first conduit
  • the second gate is adapted to control the flow of the first and/or second fluid through the second fluid conduit
  • the third gate is adapted to control the flow of the second fluid through the third fluid conduit.
  • the housing includes a heater located adjacent to the receiving region.
  • the heater may be adapted to heat a fluid within the internal cavity of the cassette.
  • the heater is a heater plate, preferably cylindrical in shape or disc shaped.
  • a duration that the fluid is heated by the heater in the internal cavity of the cassette is adjusted based on an ambient temperature.
  • the application of positive and/or negative pressure to said membrane pumps the fluid into and out of the internal cavity via a pumping action, and wherein the pumping action is performed simultaneously with heating the fluid.
  • the heater is made from a material comprising one or more of a ceramic, a ceramic oxide, a metal, a metallic oxide, and a metal coated with a ceramic or ceramic oxide.
  • the gas conduit passes through an aperture in the heater to control a movement of the membrane towards or away from the heater.
  • the pressure source is a pump.
  • the pump is preferably a twin head pump adapted to provide both the positive pressure and the negative pressure.
  • the same pump controls actuation of the gate or gates.
  • the movement of fluid into or out of the internal cavity of the cassette is actuated.
  • the medical apparatus further comprises a soundwave sensor adapted to emit or detect soundwaves through a conduit in order to detect a flow rate of the fluid passing through the conduit for use in calculating a volume of the fluid passing through the conduit.
  • the soundwave sensor is an ultrasound sensor that emits and detects ultrasonic waves of a frequency of at least 20MHz.
  • the soundwave sensor preferably includes a recessed region adapted to receive the conduit.
  • a means to securely retain the conduit is within the recessed region.
  • the soundwave sensor is adapted to measure a volume of the first fluid and/or second passing through the second conduit.
  • the medical apparatus is a dialysis machine.
  • the dialysis machine is an automated peritoneal dialysis (APD) machine.
  • the first fluid may be a dialysate and/or the second fluid may be an effluent.
  • the medical apparatus further comprises: a plurality of ports including at least a first port and a second port; and a plurality of tubes including at least a first tube and a second tube, wherein the first port includes a first indicator and the first tube includes a corresponding first indicator, and the second port includes a second indicator and the second tube includes a corresponding second indicator, and wherein the first and second indicators and corresponding first and corresponding second indicators are selected such that a user is guided to connect the first tube to the first port and is guided to connect the second tube to the second port.
  • the first and second indicators and corresponding first and corresponding second indicators are visual indicators.
  • the visual indicators include a colour coding which guides a user to connect a tube of a first colour to a port of the first colour and to connect a tube of a second colour to a port of the second colour.
  • each indicator is provided in the form of a coloured light.
  • the first indicator may be a first colour light and the corresponding first indicator may be a corresponding first colour.
  • the second indicator may be a second colour light and the corresponding second indicator may be a corresponding second colour.
  • the cassette comprises each of the ports.
  • the plurality of tubes comprises the first, second and third fluid conduits.
  • a method for detecting a flow of fluid through a conduit of a medical apparatus comprising: providing a medical apparatus having a conduit; providing a soundwave sensor adjacent to said conduit; passing a fluid through the conduit; measuring a flow rate of fluid passing through the conduit using said soundwave sensor; and calculating the total amount of the fluid passing through the conduit using the measured flow rate.
  • the soundwave sensor includes a soundwave emitter and a soundwave detector.
  • the method may include emitting a soundwave from the soundwave emitter such that the soundwave passes through the conduit and is transmitted through fluid in the conduit and is received by the soundwave detector.
  • the soundwave emitter is located on a first side of the conduit and the soundwave detector is located on a second side of the conduit opposite to the first side such that the fluid passes through the conduit between the soundwave emitter and the soundwave detector.
  • the soundwave emitter and soundwave detector are piezoelectric elements.
  • the soundwave sensor is an ultrasound sensor.
  • the ultrasound sensor preferably emits and detects ultrasonic waves.
  • the frequency of the ultrasonic waves is preferably at least 20kHz, more preferably at least 1 MHz, and optionally at least 20MHz
  • the method further comprises halting the passage of the fluid through the conduit when the calculated total amount of fluid reaches or exceeds a predetermined value.
  • the medical apparatus comprises an automated peritoneal dialysis (APD) machine.
  • the fluid is a dialysate.
  • the method may comprise delivering the dialysate to a patient through the conduit, and wherein the calculated total amount of fluid passing through the conduit is related to a total amount of dialysate delivered to the patient.
  • the fluid is an effluent and the method may comprise draining the effluent from a patient though the conduit, and the calculated total amount of fluid passing through the conduit is related to a total amount of effluent drained from the patient.
  • a medical apparatus comprising: a conduit; a soundwave sensor positioned adjacent to the conduit and adapted to emit and detect soundwaves through the conduit; and a means for pumping a fluid through the conduit, wherein the soundwave sensor is adapted to detect a flow rate of the fluid passing through the conduit to be used to calculate a volume of fluid that is pumped through the conduit.
  • the soundwave sensor is an ultrasound sensor that emits and detects ultrasonic waves of a frequency at least 20MHz.
  • the medical apparatus comprises an automated peritoneal dialysis (APD) machine.
  • the conduit is adapted to connect between the APD machine and a patient.
  • the soundwave sensor is adapted to calculate the volume of fluid delivered to the patient and/or the volume of fluid drained from the patient.
  • the soundwave sensor includes a recessed region adapted to receive the conduit.
  • the medical apparatus comprises a means to securely retain the conduit within the recessed region.
  • the conduit may be secured to the soundwave sensor using a clamp or similar device.
  • a medical apparatus comprising: a housing; a cassette having an internal cavity adapted to receive a fluid; a heater located within the housing adjacent to a receiving region adapted to receive the cassette; at least one pump adapted to move a fluid into the internal cavity of the cassette and subsequently to move the fluid out of the internal cavity of the cassette; and a plurality of conduits connected to the cassette, wherein the apparatus is adapted such that, when the cassette is positioned in the receiving region of the housing, fluid contained within the internal cavity can be heated by the heater.
  • the apparatus is adapted such that the fluid is stationary in the internal cavity while being heated by the heater.
  • the fluid is moved into the internal cavity using a negative pressure.
  • the fluid is moved out of the internal cavity using a positive pressure.
  • the pump is a twin head pump.
  • the medical apparatus includes a controller adapted to control the amount of time the fluid is contained in the internal cavity while being heated.
  • the fluid is contained in the cavity for about 1 second.
  • the fluid is contained in the cavity for about 2 seconds.
  • the fluid is contained in the cavity for about 3 seconds.
  • the fluid is contained in the cavity for about 4 seconds.
  • the fluid is contained in the cavity for about 5 seconds.
  • the fluid is contained in the cavity for about 1 to 10 seconds.
  • the fluid is contained in the cavity for about 10 seconds.
  • the fluid is contained in the cavity for about 1 to 20 seconds.
  • the heater is cylindrical. According to preferred embodiments, the heater includes a mica cover.
  • the heater includes a plate and the plate includes an aperture adapted for installation of a pneumatic fitting.
  • the heater is made from one or more of a ceramic, a ceramic oxide, a metal and/or a metallic oxide.
  • the heater may be formed from a metal which is at least partially coated with a ceramic or ceramic oxide.
  • the heater may be formed from a material such that it emits infrared radiation in the range from about 1 pm to 100pm.
  • the infrared radiation may heat up a fluid in the internal cavity of the cassette.
  • the infrared heating may be the only source of heat or alternatively the infrared radiation may heat the fluid in combination with another type of heater, such as a conductive heater.
  • the use of more than one source of heat may improve the heating efficiency and/or reduce the time to heat a fluid compared to the use of a single heat source.
  • the cassette includes a membrane.
  • the apparatus is adapted such that, when the cassette is positioned at the receiving region, the actuation of a pressure via the pneumatic fitting causes the membrane of the cassette to be pulled towards the heater plate.
  • a single pump is used to pump the fluid and to actuate the pneumatic fitting.
  • the single pump is a twin head pump.
  • the medical apparatus is an automated peritoneal dialysis (APD) machine, and the fluid is a dialysate.
  • APD automated peritoneal dialysis
  • cassette adapted for use in the medical apparatus as described above, wherein the cassette comprises an internal cavity configured to receive a fluid, and wherein the cassette comprises a plurality of ports to connect to a plurality of conduits.
  • a further aspect the present disclosure provides, a medical apparatus, comprising: a housing including a receiving region adapted to receive the above cassette; and a heater located within the housing adjacent to the receiving region, wherein the heater is adapted to heat a fluid contained within a cassette received within the receiving region.
  • a medical apparatus comprising: a cassette; a gas conduit; a source of pressure; wherein the cassette includes a membrane in communication with the gas conduit, and wherein the source of pressure is adapted to apply a positive or negative pressure through the gas conduit to control a movement of the membrane towards or away from the gas conduit.
  • the medical apparatus comprises a fluid gate having an open position and a closed position.
  • movement of the membrane towards or away from the gas conduit determines whether the fluid gate is in the open position or the closed position.
  • movement of the membrane away from the gas conduit determines that the fluid gate is in the closed position.
  • the medical apparatus comprises a plurality of said gas conduits, a plurality of said membranes and a plurality of said gates.
  • Each of said gates may have a respective open position and a respective closed position.
  • the application of the positive or negative pressure may control a respective movement of the one or more of the membranes to determine which of said gates are in said respective open and closed position.
  • each conduit includes a valve which is adapted to determine whether the source of pressure can apply the positive or negative pressure through said conduit to the respective membrane.
  • the medical apparatus comprises a first gate to control a flow of fluid to a patient, a second gate to control a flow of fluid to a drain or receptacle, and at least one third gate to control a flow of fluid from a fluid source.
  • the medical apparatus comprises a heater plate.
  • the movement of the membrane towards or away from the gas conduit relates to a movement of the membrane towards or away from the heater plate.
  • the gas conduit passes through an aperture in the heater plate.
  • the cassette comprises an internal cavity bordered on at least one side by said membrane, and wherein the internal cavity of the cassette is adapted to receive a fluid to be heated by said heater plate.
  • the pressure source is a twin head pump.
  • the medical apparatus is an automated peritoneal dialysis (APD) machine and wherein the cassette is adapted to receive a dialysate fluid.
  • APD automated peritoneal dialysis
  • the twin head pump as used in any one of the above aspects and embodiments provides a supply of positive and negative pressure to control each of said gates and to control heating the flow of dialysate fluid in the cassette to be heated by the heater plate.
  • a further aspect of the present disclosure provides a method for controlling a membrane of a cassette of a medical apparatus, comprising: providing the medical apparatus as described above; actuating the source of pressure to apply a positive or negative pressure through the gas conduit; and controlling the movement of the membrane of the cassette via the application of the positive or negative pressure.
  • a medical apparatus comprising: a plurality of ports including at least a first port and a second port; and a plurality of tubes including at least a first tube and a second tube, wherein the first port includes a first indicator and the first tube includes a corresponding first indicator, and the second port includes a second indicator and the second tube includes a corresponding second indicator, and wherein the first and second indicators and corresponding first and corresponding second indicators are selected such that a user is guided to connect the first tube to the first port and is guided to connect the second tube to the second port.
  • the first and second indictors and corresponding first and corresponding second indicators are visual indicators.
  • the visual indicators may include a colour coding which guides a user to connect a tube of a first colour to a port of the first colour and to connect a tube of a second colour to a port of the second colour.
  • the medical apparatus includes a plurality of indicators and corresponding indicators.
  • Each tube preferably corresponds to at least one port.
  • each indicator is provided in the form of a light.
  • the first indicator may be a first light, and the corresponding first indicator is a corresponding first light.
  • the second indicator may be a second light and the corresponding second indicator is a corresponding second light.
  • the medical apparatus is a dialysis machine.
  • the medical apparatus may be an automated peritoneal dialysis apparatus.
  • the plurality of ports are preferably part of a cassette, and the cassette may comprise an internal cavity adapted to receive a fluid.
  • the first indicator and second indicator may be positioned on the cassette.
  • the medical apparatus comprises a housing adapted to receive the cassette. The first indicator and second indicator may be positioned in the housing of the medical apparatus adjacent to a location of the related first and second ports when the cassette is received in the housing.
  • the first tube is adapted to deliver a fluid to or from a patient.
  • the second tube may be adapted to transmit an effluent or waste fluid to a drain or receptacle.
  • the medical apparatus comprises at least one third port and at least one third tube adapted to deliver a fluid from a container to the medical apparatus via the at least one third port.
  • Each third port preferably includes a third indicator and each third tube includes a corresponding third indicator.
  • Figure 1 shows a perspective view of an automated peritoneal dialysis (APD) cycler
  • Figure 2 shows a bottom view of a cassette
  • Figure 3 shows a partial cross-sectional view of a cassette within an automated peritoneal dialysis cycler
  • Figure 4 shows pneumatic circuit adapted for use in an automated peritoneal dialysis cycler
  • Figure 5 shows an automated peritoneal dialysis (APD) apparatus in use.
  • a preferred embodiment of the present disclosure is shown in the automated peritoneal dialysis (APD) apparatus 10 as shown in accompanying figure 5.
  • the APD apparatus 10 includes a cycler 20, shown in figure 1 , which is a machine that controls the APD process.
  • the cycler 20 has a housing 21 which contains a controller.
  • the cycler 20 includes a switch 22 which a user of the cycler 20 may actuate to turn the cycler on or off.
  • the cycler 20 further includes a display screen 23 on which the user may view information and data relating to the control and usage of the APD apparatus 10.
  • the display screen 23 may include a touch sensitive screen which the user may use to input commands.
  • the cycler 20 includes a front facing camera 24, which can be used to monitor the use of the apparatus 10 remotely or to communicate visually between the cycler 20 and a remote location.
  • the cycler 20 includes a slot 25 into which a cassette 40 can be inserted.
  • a plurality of tubes may extends from the slot 25, as shown in figure 5.
  • the cycler 20 shown in figure 1 includes a front plate 26.
  • the front plate 26 is attached to the cycler housing 21 by hinges 27. In use, the front plate 26 will be folded downwards to a use position when the cycler 20 is placed on a flat working surface.
  • the front plate 26 can be folded upwards towards the housing, when the cycler 20 is not in use.
  • the cassette slow 25 and/or the switch 22 may be obscured to prevent unwanted use of the apparatus.
  • the front plate 26 could be locked into the use position or folded up position, for example to prevent the front plate 26 from being folded up when the cycler 20 is in use or from being folded down when the cycler 20 is being transported.
  • Other embodiments of the present invention may include a different arrangement than the cycler 20 shown in figures 1 and 5, which may or may not include a front plate 26.
  • the cycler 20 further includes a rotating arm 28 extending from one side of the housing 21.
  • the rotating arm 28 includes a user actuatable handle 29.
  • the rotating arm 28 is configured such that rotation of the arm 28 via the handle 29 causes a clamping block 30 to move towards or away from an opposing block 31 , shown in figure 3.
  • the clamping block 30 and opposed block 31 are located inside the housing 21 and are at least partially aligned with the cassette slot 25.
  • the cassette slot 25 and clamping block 30 and opposed block 31 are configured such that a cassette 40 (see figures 3 and 4) can be inserted into the slot 25 and between the clamping block 30 and opposed block 31.
  • the cycler 20 may include internal guides to ensure that the cassette 40 is aligned correctly when inserted into the cassette slot 25 within the cycler housing 21.
  • the cassette 40 includes a body 41.
  • the cassette body 41 is formed of an at least partially rigid plastic material, such polyethylene, high density polyethylene (HDPE), polyurethane, poly vinyl chloride or polypropylene or materials containing these materials or their combination.
  • the cassette body 41 includes a peripheral flange region 42 and a convex surface 43.
  • the convex surface 43 may appear partially hemispherical.
  • the convex surface 43 extends outwardly from the peripheral flange region 42 to define an internal cavity 44.
  • Surrounding the internal cavity 44 on the peripheral flange region 42 is a lip 46.
  • a membrane 45 extends over the internal cavity 44. The membrane 45 being permanently attached to the lip 46 to create an airtight seal over the internal cavity 44.
  • the cassette 40 further includes four conduits 47 which extend from the internal cavity 44 towards a first end 48 of the cassette 40.
  • the conduits 47 extend beyond an edge 49 of the flange region 42 at the first end 48.
  • Each conduit 47 includes a gate 50.
  • Each gate 50 includes an opening 51 in the flange region 42 and each opening 51 is bordered on the flange region by a lip 53.
  • a membrane 52 extends over each opening 51. The membrane 52 is permanently attached to the lip 53 to create a seal over the opening 51.
  • the cavity membrane 45 and each gate membrane 52 are formed from a continuous sheet of material.
  • the material is bonded to the surface of the flange region and to the lips.
  • the bonding could be though a heat bonding process.
  • the material of the membrane may be any thin flexible material which serves the purpose of the membrane.
  • the membrane material may be a plastic material or a rubber or silicon material.
  • the membrane material is selected such that a predetermined force may be applied to the membrane without the membrane breaking or tearing.
  • the cavity membrane 45 and gate membranes can be formed of distinct sections of material.
  • the membrane(s) serve the purpose of providing an airtight seal and are formed of a suitable flexible material.
  • the conduits 47 each include a port 55.
  • the port 55 includes the section of the conduit 47 which extends beyond the edge 49 of the flange region 42.
  • the port 55 is located at the first end 48 of the conduit 47.
  • the port 55 is used to connect the cassette 40 to tubing, such as the tubing extending from the slot 25 in the cycler housing 21 as shown in figure 5.
  • the cassette 40 includes four ports 55.
  • One port 55 is adapted to connect to a tube 60 that is connected between the cassette 40 and a patient.
  • Another port 55 is adapted to connect to a tube 61 that is connected between the cassette 40 and a drain or container 68.
  • the remaining two ports 55 are adapted to each connect to tubes 62, 63 that are connected between the cassette and respective solution bags 65, 66.
  • Each solution tube 62, 63 includes an adapter at one end which is configured to connect to a corresponding port on the respective solution bag 65, 66.
  • a guidance system is provided to ensure that the correct tube 60, 61 , 62, 63 is connected to the correct corresponding port 55A, 55B, 55C, 55D of the cassette.
  • the guidance system is preferably a visual guidance system.
  • a colour coding system is used to ensure that the correct tube 60, 61 , 62, 63 is connected to the corresponding port 55A, 55B, 55C, 55D.
  • a specific colour may be assigned to the tube 60 to connect to the patient, a different colour may be assigned to the tube that connects 61 to the drain or container 68, and another colour may be assigned to the tubes 62, 63 that connect to solution bags 66, 67.
  • the colour coding could take the form of coloured ends or coloured stripes on the tubes 60, 61 , 62, 63.
  • a corresponding colour to the desired purpose, ie to connect to patient or drain/container 68 or solution bag 66, 67 could be provided on the corresponding port 55A, 55B, 55C, 55D.
  • the cassette may include colouring at or adjacent to the corresponding port 55A, 55B, 55C, 55D.
  • the colour coding on the cassette ports is provided by coloured lights.
  • LED lights could be provided adjacent to one or each port of the cassette.
  • the coloured light could shine through the port 55 if the cassette is formed from a substantially transparent or translucent material, such as that shown in figure 3.
  • the coloured lights could be provided in the cycler housing 21 adjacent to the slot 25, where the ports 55 would be located when the cassette 40 is inserted into the cycler 20.
  • the ports 55A, 55B, 55C, 55D and their corresponding tubes 60, 61 , 62, 63 include or are associated with an indicator to ensure that the correct tube is connected to the correct port for its desired purpose.
  • FIG 4 shows a schematic layout of a pneumatic control system used by the APD apparatus.
  • the pneumatic system uses a pump 70 to control a flow of positive or negative air pressure.
  • the pump 70 is preferably a twin head pump or double head pump, which is able to produce both a positive pressure and a negative pressure.
  • other types of pump could be used in combination with various other features as described herein.
  • a twin head pump is preferred since it can reduce the number of components and size of the apparatus.
  • a twin head pump includes advantages over a single pump and over the use of two separate pumps, such as the advantages discussed in the background section above.
  • the pneumatic system includes a number of lines to convey the positive and negative pressure from the pump 70 to the membrane 52 over the gates 50 and membrane 45 over the cassette cavity 44.
  • the system includes a filter 71 and a silica gel 72.
  • the filter 71 is used to remove any particulate matter in the air and can protect the pneumatic device from damage that could be caused by particulate matter contaminants.
  • the silica gel 72 is used to dry the air in the system by absorbing moisture. The drying of the air can also prevent damage to the elements of the system. Other manners of drying the air could be used in place of silica gel 72, however silica gel 72 is relatively inexpensive compared to some other methods.
  • the pump 70 creates a positive pressure and a negative pressure which is applied to the membrane 45.
  • a line 34 conveys the positive or negative pressure from the pump 70 to the membrane 45 of the cassette 40.
  • the membrane 45 is drawn towards the end of the line 34.
  • the line 34 passes through the opposed block 31.
  • a positive or negative pressure applied through line 34 will be translated into a motion of the membrane 45.
  • a negative pressure through line 34 will cause the membrane 45 to move towards the line 34, in other words towards the opposed block 31.
  • a positive pressure applied through the line 34 will cause the membrane 45 to be pushed away from the end of the line 34 and inwardly into the internal cavity 44 of the cassette 40.
  • a pumping action within the cassette 40 is created. Therefore, when one or more cassette port 55C, 55D is connected to a source of fluid 66, 67, such as via a tube 62, 63, the pumping action will cause the fluid to be drawn into the internal cavity 44 of the cassette 40 when a negative pressure is applied to line 34.
  • a subsequent positive pressure applied through line 34 will push the membrane 45 inwardly towards the internal cavity 44 and cause the fluid therein to be pumped out of a port 55.
  • the pump 70 of the pneumatic system is also utilised to actuate the gates 50 of the cassette 40.
  • the operation of the gates 50 according to the current preferred embodiment will now be discussed.
  • the cassette 40 includes four gates 50A, 50B, 50C, 50D, which control the flow of a fluid through the corresponding ports 55A, 55B, 55C, 55D.
  • the patient tube 60 which delivers fluid to and from a patient, connects to port 55A and flow of fluid therethrough is dictated by gate 50A.
  • the drain tube 61 which delivers fluid to and from the drain/container 68, connects to port 55B and flow of fluid therethrough is dictated by gate 50B.
  • the solution tubes 62, 63 which deliver fluid from bags 66, 67, connect to port 55C, 55D, respectively, and flow of fluid therethrough is dictated by gates 50C, 50D.
  • the same positive pressure and negative pressure supplied by the pump 70 can be used to control each of the gates 50A, 50B, 50C, 50D.
  • the gates 50 function in a similar manner as described above in relation to the pumping of fluid into and out of the internal cavity 44 of the cassette 40.
  • Each gate 50A, 50B, 50C, 50D is supplied with a positive or negative air pressure by a respective line 35A, 35B, 35C, 35D.
  • the lines 35 pass through the opposed block 31 with an end of the lines 35 located adjacent to a corresponding gate 50.
  • a negative pressure is applied through a line 35 the membrane 51 or the corresponding gate 50 will be drawn towards the end of the line 35, in other words towards the opposed block 31.
  • the gate lips 53 create an airtight seal around the opening at the end of the line 35 on the opposed block.
  • a positive pressure is applied via the line 35
  • the membrane 51 will be pushed away from the end of the line inwardly of the gate 50.
  • the internal shape of the gate 50 is selected to correspond to the inward movement of the membrane 51 , such that the membrane 51 can form a fluid tight seal in the gate 50 when a positive pressure is applied.
  • the application of an appropriate positive pressure via the line 35 will therefore cause the corresponding gate 50 to be closed through the membrane 51 forming a seal within the gate 50 to prevent the passage of any fluid therethrough.
  • Each of the gates 50A, 50B, 50C, 50D will function in a similar manner as one another through the application of positive or negative air pressure through their corresponding line 35A, 35B, 35C, 35D.
  • the corresponding lines 35A, 35B, 35C, 35D each include a valve 79A, 79B, 79C, 79D.
  • Each of the valves 79 will either allow or prevent the positive or negative air pressure supplied by the pump 70 to be transmitted via the line 35 to the corresponding gate membrane 51.
  • valves 79A, 79B, 79C, 79D Through the use of the valves 79A, 79B, 79C, 79D and application of either positive or negative pressure from the pump 70, the gates 50A, 50B, 50C, 50D can be individually controlled such that, when required, any gate 50A, 50B, 50C, 50D can be held in an open or closed position to allow or prevent the passage of a fluid therethrough.
  • the control of valves 79A, 79B, 79C, 79D will allow independent control of each of the gates 50A, 50B, 50C, 50D.
  • a controller within the cycler 20 will be used to control the operation of the gates and simultaneously control the pumping of fluid by internal cavity 44 of the cassette 40.
  • One advantage of the apparatus described herein, is that the same pump 70 can be used to provide positive and negative air pressure to control the functioning of the gates as well as the pumping of fluid to and from the cassette. This creates an simpler apparatus with fewer components.
  • the lines from pump 70 also include a positive regulator 73 and a negative regulator 74. These regulators 73, 74 are used to ensure that the positive and negative pressure applied through the lines are controlled and kept at desired levels.
  • the regulators 73, 74 may include sensors or regulators.
  • the pneumatic system shown in figure 4 also includes pressure sensors 75, 76. The regulators 73, 74 and pressure sensors 75, 76 may all be monitored and controlled by the controller of the cycler 20. [00113]
  • the discussion herein of a pneumatic system makes reference to application or flow of air pressure. It will be understood that systems which use gases other than air could be used to achieve the same effect.
  • the negative pressure supplied by the pump 70 may also be referred to as a vacuum pressure.
  • the cycler 20 includes an internal heater 32.
  • the heater 32 is located adjacent to the cassette 40 and, in particular, adjacent to the internal cavity 44 of the cassette 40. In this manner, an application of heat by the heater 32 may be used to directly heat any fluid which is in the internal cavity 44 of the cassette 40.
  • the heater 33 is located within the opposed plate 31 at or near to its surface.
  • the heater 32 is a disc or a flattened cylindrical plate.
  • the heater is preferably at least partly made from a ceramic material.
  • the heater plate may include a ceramic or ceramic oxide.
  • the heater may include a metal, such as a metal oxide.
  • the heater may include a metal material coated with a ceramic material.
  • the heater may be formed from a material such that it emits infrared radiation in the range from about 1 pm to 100pm.
  • the infrared radiation may heat up a fluid in the internal cavity of the cassette.
  • the infrared heating may be the only source of heat.
  • the infrared radiation may heat the fluid in combination with another type of heater, such as a conductive heater.
  • the use of more than one sources of heat may improve the heating efficiency and/or reduce the time to heat a fluid compared to the use of a single heat source.
  • the controller of the cycler 20 can be used to adjust the heating time and sequence of the pumping and gate action within the cassette 40 such that an optimised sequence may be achieved.
  • the heater plate 32 is coated with a ceramic material 32a which is adapted to increase the strength of the infrared heating that can be applied to a fluid in the cassette cavity 44.
  • a ceramic material 32a which is adapted to increase the strength of the infrared heating that can be applied to a fluid in the cassette cavity 44.
  • an ultrasound sensor 80 is provided.
  • the ultrasound sensor may be a miniature ultrasound sensor that detects a flow rate of the fluid.
  • the ultrasound sensor 80 is position adjacent or around the patient tube 60. As shown in figure 5, the tube 60 may be held in place through the centre of the ultrasound sensor 80.
  • a clamp (not shown) can be provided to keep the tube 60 in the correct position relative to sensor 80. The clamp may be part of the ultrasound sensor 80 housing.
  • the ultrasound sensor 80 functions by emitting an acoustic or sound wave from an emitter 81.
  • the soundwave is then detected by a detector 82 of the ultrasound sensor 80.
  • the soundwave emitted and detected is an ultrasound wave, also known as an ultrasonic wave.
  • the ultrasonic wave transmitting emitter may comprise a piezoelectric element.
  • the ultrasonic wave detecting detector may comprise a piezoelectric element. In the embodiment shown in figure 5, when tube 60 is in place through the sensor 80, the emitter 81 of the ultrasound sensor 80 is located on one side of the tube 60 and the detector 82 will be located on the other side of the tube.
  • the emitter and detector may be located on the same side of the tube, wherein the emitted soundwave will be reflected from an opposite side of the tube or a plate located at the opposite side and reflected back towards the detector.
  • a soundwave emitted by emitter 81 is transmitted directly through the tube 60 until it is detected by detector 82.
  • the characteristics of the soundwave are detected by the detector 82 and differences in the characteristics, such as frequency, direction or time between emission and detection, can be determined.
  • the ultrasound sensor 80 and any related control or detection elements can be adjusted to take into consideration the properties of the tube, such as wall thickness, transparency, material from which the tube is made, and inner and/or out diameter.
  • the ultrasound sensor 80 may also take into consideration the properties of the substance flowing through the tubing, such as viscosity and the type of substance. [00121 ]
  • the ultrasound sensor 80 is located externally of the patient tube 60. Therefore, the ultrasound sensor 80 does not affect the flow of fluid through tube 60. The location of the sensor outside the tube 60 will also ensure that no contamination of the fluid by the sensor housing can take place.
  • the ultrasound sensor 80 When a fluid, such as solution or dialysate, flows through the patient tube 60 towards the patient, the ultrasound sensor 80 will detect a flow rate of the fluid. The cumulative flow rate or a total amount of fluid having passed through tube 60 is calculated based on the flow rate measurements taken by the sensor 80.
  • the cycler 20 can be programmed such that, once a desired amount of fluid has passed through the tube 60 as measured by the ultrasound sensor, the cycler can stop any further fluid from being pumped towards the patient. The stopping action can be accomplished through a combination of stopping the pumping of the cassette 40 and closing the gate 50A.
  • a dwell period will follow.
  • the substance/dialysate within the peritoneal cavity of the patient will be exchanged with waste fluids (diffusion process).
  • the cycler 20 will act to begin pumping the waste fluid or effluent away from the patient.
  • the process for pumping the effluent from the patient is similar to that used to deliver a solution to the patient.
  • the pump 70 will provide a negative pressure to the membrane 45 via line 34 with gate 50A in an open position, such that effluent from the patient will be drawn into the internal cavity 44 of the cassette. No heating of the fluid (effluent) within the internal cavity 44 is required during this part of the cycle.
  • the pump 70 will introduce a positive pressure through line 34 to cause the effluent to be pumped out through gate 50B and port 55B through tube 61 and into the drain/container 68.
  • a cycle of repetitions of introduction of negative and positive pressure and pumping of effluent into and out of the cassette 40 can take place until the desired amount of effluent fluid has been withdrawn from the patient.
  • the ultrasound sensor 80 can be utilised to detect the amount of effluent that has been drained out of the patient through the patient line 60.
  • the manner of detecting a flow rate of effluent through the tube 60 is similar to that for detecting the amount of fluid that has been delivered to the patient.
  • the emitter 81 will emit an appropriate soundwave and the detector 82 will detect the soundwave with the signal generated indicative of the flow rate of effluent.
  • the emitter 81 emits a soundwave of at least 20 kHz, which is above the detectable range of the human ear.
  • the cumulative flow rate values can be converted into a total amount of effluent drained from the patient. Once a desired total amount of effluent is calculated from the flow rate values, the cycler 60 will stop the draining process.
  • the ultrasound sensor emits soundwaves in the frequency range above 20kHz. This range is above the range that is detectable by human ears and the sound waves will therefore not provide any discomfort to a patient using the machine.
  • the ultrasound sensor may emit and detect soundwaves above 1 MHz.
  • the ultrasound sensor can emit and detect soundwaves above 20MHz.
  • the use of an ultrasound sensor may be more accurate than previously used methods of detecting how much fluid has been delivered to or drained from a patient.
  • the apparatus may have an rpm sensor which monitors the revolutions per minute of the motor of the pump 70.
  • There may also be provide a voltage control to control the voltage supplied to the pump, which can be used to adjust the speed of the pump motor.
  • the speed of the pump may be adjusted to a desired level to achieve a desired positive or negative pressure. For example, if a higher amount of positive pressure is required (such as to close a gate to block a flow of fluid), the voltage control could increase the voltage supplied to increase the positive pressure applied to the pneumatic system.
  • the pressure generated is preferably controllable to adjust the usage requirements or environment of the cycler apparatus. As an example, in locations of greater height above see level, the ambient pressure may be lower, therefore the pressure required by the pump by be adjusted accordingly.
  • the cycler makes use of sensors to keep track of the usage requirements and to self-adjust the voltage supplied to the pump 70 without requiring a user input.
  • the cycler 20 preferably has an internal controller/computer which will control and track the usage of the cycler 20 and its peripheral components.
  • the cycler 20 will include a communication link, such as a mobile, cellular, Wi-Fi, broadband or other internet connection which communicates through a modem or similar device.
  • the tracking of device usage can be used in a process of self-diagnosis within the cycler 20.
  • the communication link could be used by a technician or other individual to remotely communicate with cycler 20.
  • the remote link could order a self-diagnosis process to assess that the cycler is functioning correctly, in other words the sensors, pump, pneumatic lines, heater etc. are functional.
  • the cycler controller/computer will automatically track the functioning and can cause a remote message to be sent in the event of a problem.
  • problems could be that a part needs replacing or is soon going to need to be replaced, alternatively, more critical problems such as failure of any components can be automatically and quickly communicated to a remote technician or expert.
  • the lifetime of each of the parts of the cycler apparatus can be calculated based on known values and calculations of usage status and time active.
  • the sound generated by the cycler 20 when in operation can be detected.
  • the tubes and lines in the apparatus can be kept under watch to locate any leaks and to issue an appropriate warning.
  • a status report can be sent to a remote centre to advise of maintenance requirements, part replacement schedules or any problems located and a technician can accordingly roster a suitable time to service the cycler.
  • the cycler 20 will be located within the home of the patient or user of the machine, therefore an advance warning to a technician is preferable.
  • the present disclosure relates to medical apparatus and methods of controlling said apparatus.
  • the preferred embodiments described herein relate to an automated peritoneal dialysis apparatus and related methods and systems.
  • the various aspects of the present invention may be applied more broadly for use in apparatus and methods beyond the preferred embodiments described herein.

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Abstract

La présente invention concerne un appareil médical, en particulier un appareil de dialyse péritonéale automatisée (APD) (10), comprenant un boîtier ayant une région de réception et une cassette (40) conçue pour être reçue dans la région de réception. Une pompe (70), telle qu'une pompe à double tête, peut être utilisée pour appliquer une pression positive ou négative à travers un ou plusieurs conduits (47) afin de provoquer un mouvement d'une membrane (45) pour déplacer un fluide dans ou hors d'une cavité de la cassette (40). Un procédé d'utilisation ou de commande de l'appareil médical consiste à mesurer un volume de fluide à l'aide d'un capteur d'onde sonore ; à chauffer le fluide contenu à l'intérieur de la cassette (40) ; à actionner des portes (50) à l'aide d'une pression positive et négative appliquée par une pompe (70) ; et à fournir des indicateurs visuels pour guider le raccordement d'un tube à un orifice correspondant (55).
PCT/IB2020/053332 2019-04-08 2020-04-08 Appareil pour dialyse péritonéale WO2020208532A1 (fr)

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BR112021020210A BR112021020210A2 (pt) 2019-04-08 2020-04-08 Aparelho médico e método para detectar um fluxo de fluido através de um conduto de fluido de um aparelho médico
JP2021560615A JP2022527717A (ja) 2019-04-08 2020-04-08 腹膜透析装置
CN202080027159.6A CN113825532A (zh) 2019-04-08 2020-04-08 腹膜透析设备

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MYPI2019001934 2019-04-08
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AU2019903777A AU2019903777A0 (en) 2019-10-08 Peritoneal dialysis apparatus

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