TWI859211B - A medical apparatus and a method for detecting a flow of fluid through a fluid conduit of a medical apparatus - Google Patents

Abstract

The present disclosure relates to a medical apparatus, in particular an automated peritoneal dialysis (APD) apparatus. Also provided are associated methods of use or control of the medical apparatus. A medical apparatus as described herein may include a housing having a receiving region and a cassette adapted to be received in the receiving region. A pump, such as a twin head pump, may be used to apply a positive or negative pressure through one or more conduits in order to cause a motion of a membrane to move a fluid into or out of a cavity of the cassette. Other aspects and embodiments of the present disclosure relate to: measuring a volume of fluid using a soundwave sensor; heating fluid contained within the cassette; actuating gates using positive and negative pressure applied by a pump; and providing visual indicators to guide connecting a tube to a corresponding port.

Description

A medical device and a method for detecting the flow of fluid through a fluid conduit of the medical device

The present invention relates to a medical device, such as a device for treating end-stage renal disease, and in particular to an improved automated peritoneal dialysis (APD) device. The present invention also relates to associated control systems and methods.

Dialysis is used to support patients with end-stage kidney disease, in which the kidneys no longer function to remove waste products, toxins, and excess water from the blood. The most common form of dialysis is hemodialysis. Peritoneal dialysis (PD) is a form of dialysis used to treat patients with kidney failure.

Peritoneal dialysis uses the peritoneum in the patient's abdomen as a membrane by which fluid and dissolved substances are exchanged with the patient's blood. In some cases, peritoneal dialysis may have advantages over hemodialysis, such as allowing greater flexibility in the use of patients, potentially improved outcomes during the first few years of use, and potentially improved tolerability in patients with heart disease.

Peritoneal dialysis can be performed at regular intervals throughout the day in a process generally known as continuous ambulatory peritoneal dialysis (CAPD). Alternatively, another form of peritoneal dialysis known as automated peritoneal dialysis (APD) utilizes a machine also known as a loop machine. An APD machine can be used on a patient throughout the night while the patient is asleep.

Automated peritoneal dialysis (APD) consists of: a looper (automated peritoneal dialysis machine); dialysate fluid (usually a sterile dextrose-water solution with some essential minerals); and consumables including cassettes and drainage bags. Before a patient can undergo PD treatment, a catheter must be surgically inserted into the patient's abdominal cavity (specifically the peritoneum). The looper delivers the dialysate into the patient's peritoneum during an infusion. If necessary, medications can be included with the fluid prior to the infusion.

During a period of time called the dwell period, the dialysate fluid remains in the patient's abdomen and waste products including solutes, toxins, and excess water are absorbed into the fluid via diffusion and osmosis across the concentration gradient. The circuit meter then removes the effluent/waste products from the patient's body. This cycle of infusion, diffusion, and drain (often called fill-dwell-drain) can be performed according to a set program. During an overnight program, the circuit meter can complete 3 to 10 fill-dwell-drain cycles per night. The physician can monitor this process to determine when enough cycles have been completed and the patient has clearance.

In some APD machines, a loop pre-warms the dialysate to a desired temperature (close to human body temperature) before the fluid is infused into the patient. This warming of the fluid prevents potential temperature shock in the patient that could be induced when infusing cold fluid.

Typically, the cassette will be used as a device to control the flow of dialysate fluid and effluent during infusion and drain procedures.

In order to deliver the desired amount of dialysate (volume) into the patient's peritoneum, a conventional APD loop meter will weigh the entire bag of dialysate, for example by using a weighing sensor. The weight change will be monitored throughout the dialysate filling process. When the measured weight difference equals the desired volume, the loop meter will stop the dialysate infusion/filling process into the patient. This way of calculating the volume delivered to the patient may not be as accurate as desired, for example, there may be a difference between the calculated volume and the actual volume due to changes in the density of the dialysate/effluent.

Similarly, when draining or removing effluent, some conventional APD loop meters will measure the initial weight of the drain bag, such as by using a load cell. The weight of the bag will be monitored throughout the process of draining the effluent. When the measured weight of the bag corresponds to the desired target volume, the loop meter will stop draining. This manner of calculating the volume drained from the patient may not be as accurate as desired, for example, by measuring weight, there may be a difference between the calculated volume and the actual volume.

Other conventional APD cyclers can estimate the drainage volume by calculation involving the number of pump strokes that drain, based on a fixed shape and volume of the cycler's cassette. For example, if on average 20 ml of effluent is pumped per stroke, then 100 pump strokes will drain 2000 ml of effluent. This calculation method may not be as accurate as desired, i.e., the calculated volume may not match the actual volume. The reason for this inaccuracy may be that the pumping stroke depends on: (i) the air pressure driving the pumping action; (ii) the stiffness of the elastomeric membrane and the operating temperature of the membrane, which will change the stiffness of any polymer membrane.

In order to warm the dialysate to the desired temperature, some conventional APD loops will have an external heater to warm an entire bag of dialysate. This bag to be heated is often referred to as a heating bag. The dialysate to be used will be pumped into the heating bag to be heated until the desired temperature is reached. Once at the desired temperature, the dialysate can be delivered to the patient. Before the loop begins to deliver dialysate to the patient, a period of time, typically several minutes, must elapse in order for the dialysate bag to be heated. This heating method may be more time consuming than desired, and since the entire bag of fluid is heated prior to use, the method may also be less energy efficient than desired.

Other APD loops may use an internal heater in the loop to warm the dialysate. In these loops, the cassette may contain multiple heating lines/channels. The dialysate will be pumped into the loop with the cassette and the internal heater will warm the dialysate as it flows through the heating channels before being delivered to the patient. This heating method may not allow for the desired control of the temperature of the fluid since the fluid travels through the channels for a set period of time. The only way to control the temperature in these systems would be to add heat to the heater, which would result in increased energy consumption of the machine and higher variability in the delivered temperature.

To direct the flow of dialysate and effluent to and from the patient, traditional APD loopers may utilize mechanical actuators to physically open and close gates/valves to the various channels in the cassette. The flow may be controlled by mechanically manipulating the correct gate/valves to an open or closed position using an actuator. The use of mechanical actuators in traditional systems may be more complex and use more parts than desired.

Traditional APD loops may include a single pump to move dialysate to the patient. The single pump will generate a single fixed positive pressure to pump dialysate into the patient during the fill process. For effluent outflow, these loops will use gravity to drain the effluent from the patient. A single pump and a gravity-driven drain may impose placement restrictions, such as requiring the machine to be placed at a specific height, which may not be desirable.

Other APD loops may use two separate pumps to move dialysate and effluent to and from the patient. One pump is used to create positive pressure to move dialysate into the patient, and the other pump creates negative pressure or vacuum to remove effluent from the patient. In this APD loop, the pressure of each pump is fixed. Using two pumps can make the APD machine larger, heavier, more expensive, and less energy efficient than desired.

If any malfunction or problem occurs with the APD loop, a qualified technician must personally inspect the loop to evaluate if the malfunction exists in the loop, which is typically located in the patient’s home.

Existing APD machines include Baxter's HomeChoice APD machine and Fresenius's Medical Care SleepSafe APD loop. These machines include one or more of the features described above and include similar disadvantages.

It would be desirable to provide an automated peritoneal dialysis (APD) device that overcomes one or more problems associated with conventional APD loopers, such as those discussed above.

Provided herein is a medical device comprising: a housing; a box adapted to be received in a receiving area of the housing, the box comprising at least one membrane; at least one gas conduit; and a pressure source; wherein the at least one membrane is in communication with at least one fluid in the at least one gas conduit, and wherein the pressure source is adapted to apply positive and/or negative pressure through the at least one gas conduit to control the movement of the at least one membrane.

According to a preferred aspect, the present invention provides a medical device comprising: a fluid conduit; an ultrasound sensor positioned adjacent to the fluid conduit and adapted to emit and detect sound waves passing through the fluid conduit; and a device for pumping fluid through the fluid conduit, wherein the ultrasound sensor is adapted to detect a flow rate of the fluid passing through the fluid conduit, the flow rate being used to calculate a volume of fluid pumped through the fluid conduit, wherein the medical device is an automated peritoneal dialysis (APD) machine.

Also described herein is a medical device, wherein the medical device is preferably an automated peritoneal dialysis (APD) machine, the medical device comprising: a housing; a cassette adapted to be received in a receiving area of the housing, the cassette comprising at least one membrane; at least one gas conduit; and a pressure source; wherein the at least one membrane is in communication with at least one fluid in the at least one gas conduit, wherein the pressure source is adapted to apply positive and/or negative pressure through the at least one gas conduit to control movement of the at least one membrane, and wherein the cassette comprises an inner cavity adapted to receive the fluid, wherein the inner cavity is adjacent to a membrane in the at least one membrane on at least one side, and wherein application of positive and/or negative pressure to the membrane causes the fluid to move into or out of the inner cavity.

According to an embodiment, at least one membrane moves toward or away from the opening of at least one gas duct, depending on whether the applied pressure is positive or negative.

The medical device may also include a fluid gate having an open position and a closed position. Movement of the membrane toward or away from the gas conduit may determine whether the fluid gate is in the open position or the closed position.

According to an embodiment, the medical device includes multiple gas tubes, multiple membranes, and multiple gates. Each gate can have a corresponding open position and a corresponding closed position, and the application of positive pressure and/or negative pressure can control the corresponding movement of the membrane to determine which of the gates are in the corresponding open and closed positions.

According to an embodiment, each conduit includes a valve adapted to determine whether a pressure source can apply positive and/or negative pressure to the corresponding membrane through the conduit.

The medical device may include at least one first gate to control the flow of fluid from a fluid source; a second gate to control the flow of fluid to a patient; and a third gate to control the flow of fluid to a drainage tube or container.

According to an embodiment, the box includes one or more gates.

According to an embodiment, the box includes an inner cavity suitable for receiving a fluid. The inner cavity can be adjacent to a membrane in at least one membrane on at least one side. Application of positive pressure and/or negative pressure to the membrane can cause the fluid to move into or out of the inner cavity.

The medical device may also include: at least one first fluid conduit, the at least one first fluid conduit is suitable for transferring a first fluid from a fluid source to an inner cavity of the box; a second fluid conduit, the second fluid conduit is suitable for transferring a first fluid from the inner cavity to a patient and/or transferring a second fluid from a patient to the inner cavity; and a third fluid conduit, the third fluid conduit is suitable for transferring a second fluid from the inner cavity to a drainage tube or a container.

According to an embodiment, at least one first gate is adapted to control the flow of a first fluid through at least one first conduit, a second gate is adapted to control the flow of a first fluid and/or a second fluid through a second fluid conduit, and a third gate is adapted to control the flow of a second fluid through a third fluid conduit.

According to an embodiment, the housing includes a heater positioned adjacent to the receiving area. The heater may be adapted to heat the fluid within the inner cavity of the cartridge. According to an embodiment, the heater is a heating plate, preferably cylindrical or disc-shaped.

According to an implementation, the duration of the fluid being heated by the heater in the inner cavity of the cartridge is regulated based on the ambient temperature.

According to an embodiment, the application of positive and/or negative pressure to the membrane pumps the fluid into and out of the inner cavity via a pumping action, and wherein the pumping action is performed simultaneously with heating the fluid.

According to an embodiment, the heater is made of a material including one or more of the following: ceramic, ceramic oxide, metal, metal oxide, and metal coated with ceramic or ceramic oxide.

Depending on the implementation, a gas duct is passed through a hole in the heater to control the movement of the membrane toward or away from the heater.

According to an embodiment, the pressure source is a pump. The pump is preferably a double-headed pump suitable for providing both positive pressure and negative pressure.

Depending on the implementation, the same pump controls the actuation of one or more gates. Preferably, the movement of fluid into or out of the inner cavity of the box is controlled.

According to an embodiment, the medical device further includes an acoustic sensor adapted to emit or detect acoustic waves passing through the catheter so as to detect the flow rate of the fluid passing through the catheter, which flow rate is used to calculate the volume of the fluid passing through the catheter. Preferably, the acoustic sensor is an ultrasonic sensor that emits and detects ultrasonic waves with a frequency of at least 20 MHz. The acoustic sensor preferably includes a recessed area adapted to receive the catheter. According to an embodiment, the device for firmly holding the catheter is in the recessed area. Preferably, the acoustic sensor is adapted to measure the volume of the first fluid and/or the second fluid passing through the second catheter.

According to a preferred embodiment, the medical device is a dialysis machine. Preferably, 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.

According to an embodiment, the medical device further includes: a plurality of ports, the ports including at least a first port and a second port; and a plurality of tubes, the tubes including at least a first tube and a second tube, wherein the first port includes a first indicator, the first tube includes a corresponding first indicator, the second port includes a second indicator, and the second tube includes a corresponding second indicator, and wherein the first indicator and the second indicator and the corresponding first indicator and the corresponding second indicator are selected so as to guide a user to connect the first tube to the first port, and guide a user to connect the second tube to the second port.

According to an embodiment, the first indicator and the second indicator and the corresponding first indicator and the corresponding second indicator are visual indicators. Preferably, the visual indicator includes a color code that guides the user to connect the tube of the first color to the port of the first color and to connect the tube of the second color to the port of the second color.

According to an embodiment, each indicator is provided in the form of a colored light. The first indicator may be a first color light, and the corresponding first indicator may be a corresponding first color. The second indicator may be a second color light, and the corresponding second indicator may be a corresponding second color.

According to an embodiment, the box includes various ports. According to an embodiment, the plurality of tubes include a first fluid conduit, a second fluid conduit, and a third fluid conduit.

According to aspects of the present invention, a method for detecting the flow of a fluid through a catheter of a medical device is provided, the method comprising the steps of: providing a medical device having a catheter; providing an acoustic wave sensor adjacent to the catheter; allowing the fluid to pass through the catheter; using the acoustic wave sensor to measure the flow rate of the fluid passing through the catheter; and using the measured flow rate to calculate the total amount of the fluid passing through the catheter.

According to a preferred embodiment, the acoustic wave sensor includes an acoustic wave transmitter and an acoustic wave detector. The method may include the following steps: emitting acoustic waves from the acoustic wave transmitter so that the acoustic waves pass through the conduit and are transmitted through the fluid in the conduit and are received by the acoustic wave detector.

According to a preferred embodiment, the acoustic wave transmitter is located on a first side of the conduit, and the acoustic wave detector is located on a second side of the conduit opposite to the first side, so that the fluid passes through the conduit between the acoustic wave transmitter and the acoustic wave detector.

According to a preferred embodiment, the sound wave transmitter and the sound wave detector are piezoelectric elements.

According to a preferred embodiment, the acoustic sensor is an ultrasonic sensor. The ultrasonic sensor preferably emits and detects ultrasonic waves. The frequency of the ultrasonic waves is preferably at least 20kHz, more preferably at least 1MHz, and optionally at least 20MHz.

According to a preferred embodiment, the method further comprises the following step: when the calculated total amount of fluid reaches or exceeds a predetermined value, the fluid is stopped from passing through the conduit.

According to an embodiment, the medical device includes an automated peritoneal dialysis (APD) machine. Optionally, the fluid is a dialysate. The method may include the steps of delivering the dialysate to a patient via a catheter, and wherein the calculated total amount of fluid passing through the catheter is related to the total amount of dialysate delivered to the patient. According to an embodiment, the fluid is an effluent, and the method may include the steps of draining the effluent from the patient via the catheter, and wherein the calculated total amount of fluid passing through the catheter is related to the total amount of effluent drained from the patient.

According to another aspect of the present invention, a medical device is provided, the medical device comprising: a catheter; an acoustic wave sensor positioned adjacent to the catheter and adapted to emit and detect acoustic waves passing through the catheter; and a device for pumping fluid through the catheter, wherein the acoustic wave sensor is adapted to detect a flow rate of the fluid passing through the catheter, the flow rate being used to calculate a volume of the fluid pumped through the catheter.

According to a preferred embodiment, the ultrasonic sensor is an ultrasonic sensor that emits and detects ultrasonic waves with a frequency of at least 20 MHz.

According to an embodiment, the medical device includes an automated peritoneal dialysis (APD) machine. According to a preferred embodiment, the catheter is adapted to be connected between the APD machine and the patient. Preferably, the acoustic wave sensor is adapted to calculate the volume of fluid delivered to the patient and/or the volume of fluid drained from the patient.

According to a preferred embodiment, the acoustic wave sensor includes a recessed area suitable for receiving a catheter. Preferably, the medical device includes a device for firmly holding the catheter in the recessed area. For example, the catheter can be fixed to the acoustic wave sensor using a clamp or similar device.

According to another aspect of the present invention, a medical device is provided, the medical device comprising: a housing; a box having an inner cavity adapted to receive a fluid; a heater located within the housing adjacent to a receiving area adapted to receive the box; at least one pump adapted to move the fluid into the inner cavity of the box and subsequently move the fluid out of the inner cavity of the box; and a plurality of conduits connected to the box, wherein the device is adapted such that when the box is positioned in the receiving area of the housing, the fluid contained in the inner cavity can be heated by the heater.

According to a preferred embodiment, the apparatus is adapted to allow the fluid to remain stationary in the inner chamber while being heated by the heater.

According to a preferred embodiment, negative pressure is used to move the fluid into the inner cavity. According to a preferred embodiment, positive pressure is used to move the fluid out of the inner cavity.

According to a preferred embodiment, the pump is a double-head pump.

According to a preferred embodiment, the medical device includes a controller adapted to control the amount of time the fluid is contained in the inner cavity while being heated. According to an embodiment, the fluid is contained in the cavity for approximately 1 second. According to an embodiment, the fluid is contained in the cavity for approximately 2 seconds. According to an embodiment, the fluid is contained in the cavity for approximately 3 seconds. According to an embodiment, the fluid is contained in the cavity for approximately 4 seconds. According to an embodiment, the fluid is contained in the cavity for approximately 5 seconds. According to an embodiment, the fluid is contained in the cavity for approximately 1 to 10 seconds. According to an embodiment, the fluid is contained in the cavity for approximately 10 seconds. According to an embodiment, the fluid is contained in the cavity for approximately 1 to 20 seconds.

According to a preferred embodiment, the heater is cylindrical. According to a preferred embodiment, the heater includes a mica cover.

According to a preferred embodiment, the heater comprises a plate, and the plate comprises an orifice suitable for mounting a pneumatic accessory.

According to a preferred embodiment, the heater is made of one or more of a ceramic, a ceramic oxide, a metal and/or a metal oxide. According to an embodiment, the heater may be formed of a metal at least partially coated with a ceramic or a ceramic oxide. The heater may be formed of a material that causes it to emit infrared radiation in the range of about 1 μm to 100 μm. The infrared radiation may heat the fluid in the inner cavity of the box. Infrared heating may be the only heat source, or alternatively, infrared radiation may be combined with another type of heater (such as a conductive heater) to heat the fluid. Using more than one heat source may increase heating efficiency and/or reduce the time to heat the fluid compared to using a single heat source.

According to a preferred embodiment, the box comprises a membrane. Preferably, the device is adapted so that when the box is positioned at the receiving area, pressure actuation by the pneumatic fitting causes the membrane of the box to be pulled towards the heating plate.

According to a preferred embodiment, a single pump is used to pump the fluid and actuate the pneumatic accessories. According to a preferred embodiment, the single pump is a dual-head pump.

According to a preferred embodiment, the medical device is an automated peritoneal dialysis (APD) machine, and the fluid is a dialysate.

Another aspect of the invention provides a box suitable for use in a medical device as described above, wherein the box includes an inner cavity configured to receive a fluid, and wherein the box includes a plurality of ports connected to a plurality of catheters.

Another aspect of the present invention provides a medical device, which includes: a housing, the housing including a receiving area suitable for receiving the above-mentioned box; and a heater, the heater is located in the housing and adjacent to the receiving area, wherein the heater is suitable for heating the fluid contained in the box received in the receiving area.

According to another aspect of the present invention, a medical device is provided, the medical device comprising: a box; a gas catheter; a pressure source; wherein the box comprises a membrane connected to the gas catheter, and wherein the pressure source is suitable for applying positive pressure or negative pressure through the gas catheter to control the movement of the membrane toward or away from the gas catheter.

According to a preferred embodiment, the medical device includes a fluid gate having an open position and a closed position. Preferably, movement of the membrane toward or away from the gas conduit determines whether the fluid gate is in the open position or in the closed position. Preferably, movement of the membrane away from the gas conduit determines whether the fluid gate is in the closed position.

According to a preferred embodiment, the medical device includes a plurality of the gas tubes, a plurality of the membranes, and a plurality of the gates. Each of the gates may have a corresponding open position and a corresponding closed position. The application of positive or negative pressure may control the corresponding movement of one or more membranes to determine which of the gates are in the corresponding open and closed positions.

According to a preferred embodiment, each conduit includes a valve adapted to determine whether a pressure source can apply positive and/or negative pressure to the corresponding membrane through said conduit.

According to a preferred embodiment, the medical device includes a first gate that controls the flow of fluid to the patient, a second gate that controls the flow of fluid to the drainage tube or container, and at least one third gate that controls the flow of fluid from the fluid source.

According to a preferred embodiment, the medical device includes a heating plate. According to a preferred embodiment, the movement of the membrane toward or away from the gas conduit is related to the movement of the membrane toward or away from the heating plate. According to a preferred embodiment, the gas conduit passes through a hole in the heating plate.

According to a preferred embodiment, the box includes an inner cavity, which is adjacent to the membrane on at least one side, and wherein the inner cavity of the box is suitable for receiving a fluid to be heated by the heating plate.

According to a preferred embodiment, the pressure source is a double-head pump.

According to a preferred embodiment, the medical device is an automated peritoneal dialysis (APD) machine, and wherein the cassette is adapted to receive a dialysate fluid.

According to a preferred embodiment, a dual head pump as used in any of the above aspects and embodiments provides a supply of positive and negative pressures to control each of the gates and control the heating of the flow of dialysate fluid in the box to be heated by the heating plate.

Another aspect of the present invention provides a method for controlling a membrane of a box of a medical device, the method comprising the steps of: providing a medical device as described above; actuating a pressure source to apply positive pressure or negative pressure via a gas conduit; and controlling the movement of the membrane of the box by applying the positive pressure or negative pressure.

Another aspect of the present invention relates to a medical device comprising: a plurality of ports, the ports comprising at least a first port and a second port; and a plurality of tubes, the tubes comprising at least a first tube and a second tube, wherein the first port comprises a first indicator, the first tube comprises a corresponding first indicator, the second port comprises a second indicator, and the second tube comprises a corresponding second indicator, and wherein the first indicator and the second indicator and the corresponding first indicator and the corresponding second indicator are selected so as to guide a user to connect the first tube to the first port, and guide the user to connect the second tube to the second port.

According to an embodiment, the first indicator and the second indicator and the corresponding first indicator and the corresponding second indicator are visual indicators. The visual indicator may include a color code that guides the user to connect the first color tube to the first color port and the second color tube to the second color port.

According to a preferred embodiment, the medical device includes multiple indicators and corresponding indicators. Each tube preferably corresponds to at least one port.

Optionally, each indicator is provided in the form of a lamp. The first indicator may be a first lamp, and the corresponding first indicator is the corresponding first lamp. The second indicator may be a second lamp, and the corresponding second indicator is the corresponding second lamp.

According to an embodiment, the medical device is a dialysis machine. The medical device may be an automated peritoneal dialysis device. The plurality of ports are preferably part of a cassette, and the cassette may include an inner cavity adapted to receive a fluid. The first indicator and the second indicator may be positioned on the cassette. Optionally, the medical device includes a housing adapted to receive the cassette. When the cassette is received in the housing, the first indicator and the second indicator may be positioned in the housing of the medical device adjacent to the location of the associated first port and the second port.

Depending on the implementation, the first tube is adapted to convey fluid to or from a patient. The second tube may be adapted to convey effluent or waste fluid to a drain or container.

According to an embodiment, the medical device includes at least one third port and at least one third tube, wherein the at least one third tube is suitable for delivering fluid from the container to the medical device via the at least one third port. Each third port preferably includes a third indicator, and each third tube includes a corresponding third indicator.

It will be understood that any one of the above aspects or embodiments or features described herein may be used in combination with any of the other described aspects and embodiments.

10: Equipment

20: Loop Meter

21: Loop instrument housing

22: Switch

23: Display screen

24: Camera

25: Slot

26: Front panel

27: Hinge

28: Rotating arm

29: Handle

30: Clamping block

31:Relative block

32: Heater/heating plate

32a: Ceramic materials

33: Heating hole

34: Pipeline

35: Pipeline

35A: Pipeline

35B: Pipeline

35C: Pipeline

35D: Pipeline

40: Box

41:Box body

42: flange area

43: Convex

44: Inner cavity

45: Cavity membrane

46: Lip rim

47: Catheter

48: First end

49:Edge of the flange area

50: Gate

50A: Gate

50B: Gate

50C: Gate

50D: Gate

51: Open mouth

52: Membrane

53: Gate lip edge

55: Port

55A: Port

55B: Port

55C: Port

55D: Port

60: Patient management

61: Drainage tube

62: First solution tube

63: Second solution tube

64: First adapter

65: Second adapter

66: First solution bag

67: Second solution bag

68: Drainage tube/container

70: Pump

71: Air filter program

72:Silicone

73: Positive regulator

74: Negative regulator

75: First pressure sensor

76: Second pressure sensor

77: Positive pressure valve

78: Negative pressure valve

79: Gate valve

80:Ultrasonic sensor

81: Transmitter

82: Detector

The present invention may be better understood by reference to preferred embodiments as shown in the accompanying drawings, wherein: [FIG. 1] shows a perspective view of an automated peritoneal dialysis (APD) cycler; [FIG. 2] shows a bottom view of a cassette; [FIG. 3] shows a partial cross-sectional view of a cassette within an automated peritoneal dialysis cycler; [FIG. 4] shows a pneumatic circuit suitable for use in an automated peritoneal dialysis cycler; and [FIG. 5] shows an automated peritoneal dialysis (APD) apparatus in use.

A preferred embodiment of the present invention is shown in an automated peritoneal dialysis (APD) device 10 as shown in Figure 5. The APD device 10 includes a loop meter 20 as shown in Figure 1, which is a machine that controls the APD process. The loop meter 20 has a housing 21 that houses a controller. The loop meter 20 includes a switch 22, which a user of the loop meter 20 can actuate to turn the loop meter on or off. The loop meter 20 also includes a display screen 23, on which the user can view information and data related to the control and use of the APD device 10. The display screen 23 may include a touch screen that the user can use to enter commands. Alternatively, a separate input device such as a mouse, keyboard or other input device may be used to input commands or control the device. The loop meter 20 includes a front camera 24 that may be used to remotely monitor the use of the device 10 or to provide visual communication between the loop meter 20 and a remote location.

The looper 20 includes a slot 25 into which the box 40 can be inserted. When the box 40 is inserted into the slot 25, a plurality of tubes can extend from the slot 25, as shown in FIG. 5.

The cycler 20 shown in FIG. 1 includes a front plate 26. The front plate 26 is attached to the cycler housing 21 by a hinge 27. In use, when the cycler 20 is placed on a flat work surface, the front plate 26 will be folded down to a use position. When the cycler 20 is not in use, the front plate 26 can be folded up toward the housing. When the front plate 26 is folded up, the box slot 25 and/or the switch 22 can be obscured to prevent undesired use of the device. In an embodiment (not shown), the front plate 26 can be locked into the use position or the 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 transported. Other embodiments of the present invention may include different arrangements of the circuit meter 20 than those shown in FIGS. 1 and 5 , which arrangements may or may not include the front plate 26 .

The cycler 20 also includes a swivel arm 28 extending from one side of the housing 21. The swivel arm 28 includes a handle 29 that can be actuated by a user. The swivel arm 28 is configured so that the arm 28 causes the clamping block 30 to move toward or away from the opposing block 31 via rotation of the handle 29, as shown in FIG. 3. The clamping block 30 and the opposing block 31 are located inside the housing 21 and are at least partially aligned with the box slot 25. The box slot 25 and the clamping block 30 and the opposing block 31 are configured so that the box 40 (see FIGS. 3 and 4) can be inserted into the slot 25 and between the clamping block 30 and the opposing block 31. Actuation of the handle 29 in a first direction when the cartridge 40 is between the blocks 30, 31 will cause the clamping block 30 to move toward the opposing block 31 until a final position is reached where the cartridge 40 will be held in a desired position by the clamping block 30 against the opposing block 31. Subsequent actuation of the handle 29 in a second direction will cause the clamping block 30 to move away from the opposing block 31 so that the cartridge 40 can be removed from its position. In some embodiments (not shown), the looper 20 may include internal guides that ensure that the cartridge 40 is properly aligned when inserted into the cartridge slot 25 within the looper housing 21.

An embodiment of the box 40 is shown in FIG. 3 . The box 40 includes a body 41 . Preferably, the box body 41 is formed of an at least partially rigid plastic material, such as polyethylene, high-density polyethylene (HDPE), polyurethane, polyvinyl chloride or polypropylene or a material containing these materials or a combination thereof. The box body 41 includes a peripheral flange area 42 and a convex surface 43. The convex surface 43 may be partially hemispherical. The convex surface 43 extends outward from the peripheral flange area 42 to define an inner cavity 44. Surrounding the inner cavity 44 on the peripheral flange area 42 is a lip 46. A membrane 45 extends over the inner cavity 44. The membrane 45 is permanently attached to the lip 46 to form an airtight seal over the inner cavity 44.

The box 40 also includes four conduits 47 extending from the inner cavity 44 toward the first end 48 of the box 40. The conduits 47 extend beyond the edge 49 of the flange area 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 adjacent to a lip 53 on the flange region. A membrane 52 extends over each opening 51. The membrane 52 is permanently attached to the lip 53 to form a seal over the opening 51.

In the embodiment shown in FIG. 3 , the cavity membrane 45 and each membrane 52 are formed of a continuous sheet of material. The material is bonded to the surface of the flange area and the lip. For example, the bonding can be performed by a thermal bonding process. The material of the membrane can be any thin flexible material used for the purpose of the membrane. For example, the membrane material can be a plastic material or a rubber or silicone material. Preferably, the membrane material is selected so that a predetermined force can be applied to the membrane without breaking or tearing the membrane. According to other embodiments, the cavity membrane 45 and the membrane 52 can be formed of different material parts. The membrane is used for the purpose of providing an airtight seal and is formed of a suitable flexible material.

The conduits 47 each include a port 55. The port 55 includes a portion of the conduit 47 that extends beyond the edge 49 of the flange area 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 a conduit, such as a conduit extending from the slot 25 in the loop housing 21, as shown in FIG. 5.

In the embodiment shown in the accompanying drawings, the box 40 includes four ports 55. One port 55 is adapted to connect to a tube 60 connected between the box 40 and the patient. Another port 55 is adapted to connect to a tube 61 connected between the box 40 and a drain tube or container 68. The remaining two ports 55 are adapted to each connect to a tube 62, 63 connected between the box and a corresponding solution bag 65, 66. Each solution tube 62, 63 includes an adapter at one end that is configured to connect to a corresponding port on a corresponding solution bag 65, 66.

According to a preferred embodiment of the APD device (not shown in the figure), a guidance system is provided to ensure that the correct tubes 60, 61, 62, 63 are connected to the correct corresponding ports 55A, 55B, 55C, 55D of the box. The guidance system is preferably a visual guidance system. In one embodiment, a color coding system is used to ensure that the correct tubes 60, 61, 62, 63 are connected to the corresponding ports 55A, 55B, 55C, 55D. For example, a tube 60 connected to the patient can be assigned a specific color, a tube 61 connected to a drain or container 68 can be assigned a different color, and a tube 62, 63 connected to a solution bag 66, 67 can be assigned another color. The color coding can take the form of colored ends or colored stripes on the tubes 60, 61, 62, 63. Colors corresponding to the desired purpose (i.e., connection to a patient or drain tube/container 68 or solution bag 66, 67) may be provided on the corresponding ports 55A, 55B, 55C, 55D. In embodiments, the cassette may include colors at or near the corresponding ports 55A, 55B, 55C, 55D. In certain embodiments, the color coding on the cassette ports is provided by colored lights. For example, LED lights may be provided adjacent to one or each of the ports of the cassette. If the cassette is formed of a substantially transparent or translucent material (such as the cassette shown in FIG. 3), the colored lights may shine through the ports 55. Depending on the embodiment, the colored lights may be provided in the loop housing 21 adjacent to the slot 25, where the ports 55 will be located when the cassette 40 is inserted into the loop 20. In a broader context, ports 55A, 55B, 55C, 55D and their corresponding tubes 60, 61, 62, 63 include or are associated with indicators to ensure that the correct tube is connected to the correct port for its intended purpose.

FIG4 shows a schematic layout of a pneumatic control system used by an APD device. The pneumatic system uses a pump 70 to control the flow of positive or negative air pressure. Pump 70 is preferably a dual-head pump capable of generating both positive and negative pressures. For certain aspects of the invention, other types of pumps may be used in combination with various other features described herein. However, a dual-head pump is preferred because it reduces the number of components and the size of the device. A dual-head pump includes advantages over a single pump and over using two separate pumps, such as those discussed in the background section above.

The pneumatic system includes a number of lines that carry positive and negative pressures from a pump 70 to a membrane 52 above a gate 50 and a membrane 45 above a cassette chamber 44. To ensure that the air pumped around the system is clean and suitable for use, the system includes a filter 71 and silicone 72. The filter 71 is used to remove any particulate matter from the air and can protect the pneumatics from damage that may be caused by particulate matter contamination. The silicone 72 is used to dry the air in the system by absorbing moisture. Drying the air can also prevent damage to system components. Other ways of drying the air can be used instead of silicone 72, however, silicone 72 is relatively inexpensive compared to some other methods.

To enable pumping of the fluid within the inner cavity 44 of the cassette 40, the pump 70 generates positive and negative pressures that are applied to the membrane 45. The line 34 seen in FIGS. 3 and 4 delivers the positive or negative pressure from the pump 70 to the membrane 45 of the cassette 40. When negative pressure is applied, the membrane 45 is pulled toward one end of the line 34. In this embodiment, the line 34 passes through the opposing block 31. When the user actuates the handle 29, the cassette 40 will be held in place between the clamping block 30 and the opposing block 31. When the cassette 40 is held in place, the lip 46 forms a seal around one end of the line 34 against the opposing block 31. Through this seal, positive or negative pressure applied through the line 34 will be converted into movement of the membrane 45. Negative pressure through the line 34 will cause the membrane 45 to move toward the line 34 (in other words, toward the relative block 31). Positive pressure applied through the line 34 will cause the membrane 45 to be pushed away from one end of the line 34 and inwardly into the inner cavity 44 of the cassette 40. By this action of applying positive and negative pressure through the line 34, a pumping action within the cassette 40 is generated. Therefore, when one or more of the cassette ports 55C, 55D are connected to a fluid source 66, 67, for example via tubes 62, 63, the pumping action will cause fluid to be drawn into the inner cavity 44 of the cassette 40 when negative pressure is applied to the line 34. Positive pressure applied via line 34 will then push membrane 45 inwardly toward lumen 44 and cause the fluid therein to be pumped out of port 55.

The pump 70 of the pneumatic system is also used to actuate the gates 50 of the cassette 40. The operation of the gates 50 according to the presently preferred embodiment will now be discussed. The cassette 40 includes four gates 50A, 50B, 50C, 50D that control the flow of fluid through corresponding ports 55A, 55B, 55C, 55D. A patient tube 60 that delivers fluid to and from a patient is connected to port 55A, and the flow of fluid through the tube is regulated by gate 50A. A drain tube 61 that delivers fluid to and from a drain tube/container 68 is connected to port 55B, and the flow of fluid through the tube is regulated by gate 50B. Solution tubes 62, 63 conveying fluid from bags 66, 67 are connected to ports 55C, 55D respectively, and the flow of fluid through these tubes is regulated by gates 50C, 50D.

The same positive and negative pressure supplied by pump 70 can be used to control each of gates 50A, 50B, 50C, 50D. Gate 50 functions in a similar manner to that described above with respect to pumping fluid into and out of chamber 44 of box 40. Each gate 50A, 50B, 50C, 50D is supplied with positive or negative air pressure by a corresponding pipeline 35A, 35B, 35C, 35D. In the embodiment shown in FIG. 3 , pipelines 35A-D pass through relative block 31, with one end of pipelines 35A-D positioned adjacent to the corresponding gate 50. When negative pressure is applied through the pipeline 35, the membrane 52 or corresponding gate 50 will be pulled toward one end of the pipeline 35, in other words, toward the opposing block 31. The gate lip 53 creates an airtight seal around the opening of the pipeline 35 at one end on the opposing block. When positive pressure is applied through the pipeline 35, the membrane 52 will be pushed inwardly from the gate 50 away from one end of the pipeline. Preferably, the internal shape of the gate 50 is selected to correspond to the inward movement of the membrane 52 so that when positive pressure is applied, the membrane 52 can form a liquid-tight seal in the gate 50. Therefore, the application of an appropriate positive pressure through the pipeline 35 will cause the corresponding gate 50 to close with the membrane 52, which forms a seal within the gate 50 to prevent any fluid from passing through. Each of the gates 50A, 50B, 50C, 50D will function in a similar manner to one another by applying positive or negative air pressure via its corresponding line 35A, 35B, 35C, 35D.

To further control the opening and closing of the gates 50A, 50B, 50C, 50D, the corresponding pipelines 35A, 35B, 35C, 35D each include a valve 79A, 79B, 79C, 79D. Each valve 79 will allow or prevent the positive or negative air pressure supplied by the pump 70 from being transmitted to the corresponding membrane 52 via the pipeline 35. By using the valves 79A, 79B, 79C, 79D and applying positive or negative pressure from the pump 70, the gates 50A, 50B, 50C, 50D can be independently controlled so that any gate 50A, 50B, 50C, 50D can be maintained in an open or closed position to allow or prevent fluid from passing through when necessary. Control of valves 79A, 79B, 79C, 79D will allow independent control of each of gates 50A, 50B, 50C, 50D.

A controller within the looper 20 will be used to control the operation of the gate and simultaneously control the pumping of fluid into the interior chamber 44 of the cassette 40. One advantage of the apparatus described herein is that the same pump 70 can be used to provide both positive and negative air pressures to control the function of the gate and the pumping of fluid to and from the cassette. This results in a simpler apparatus with fewer components.

As shown in FIG4 , the pipeline from the pump 70 also includes a positive regulator 73 and a negative regulator 74. These regulators 73, 74 are used to ensure that the positive and negative pressures applied through the pipeline are controlled and maintained at the desired level. The regulators 73, 74 may include sensors or regulators. The pneumatic system shown in FIG4 also includes pressure sensors 75, 76. The regulators 73, 74 and the pressure sensors 75, 76 can all be monitored and controlled by the controller of the loop meter 20.

The discussion of pneumatic systems herein refers to the application or flow of air pressure. It will be understood that systems using gases other than air may also be used to achieve the same effect. The negative pressure supplied by pump 70 may also be referred to as vacuum pressure. It is also noted that the application of positive pressure is used for certain actions, while the application of negative pressure generally performs the opposite function. It is within the scope of the present invention to switch one or more actions performed by positive and negative pressures by changing the internal layout of the box or the placement of the box membrane. The specific embodiments described herein and shown in the accompanying drawings are merely preferred embodiments, and the scope of the resulting patent application should not be limited to these precisely described embodiments.

As shown in FIG3 , the looper 20 includes an internal heater 32. The heater 32 is positioned adjacent to the box 40, and in particular, adjacent to the inner cavity 44 of the box 40. In this way, the heat applied by the heater 32 can be used to directly heat any fluid in the inner cavity 44 of the box 40. In the embodiment shown in FIG3 , the heater 32 is located within the relative block 31, at or near its surface. The heater 32 is a disc or a flat cylindrical plate, i.e., a heating plate 32.

The line 34 passes through the heating plate 32. Thus, when negative pressure is applied via the line 34, the membrane 45 is pulled toward the heating plate 32, which will result in more efficient heating of the fluid in the inner cavity 44 of the box 40.

The heater is preferably at least partially made of a ceramic material. For example, the heating plate may include a ceramic or a ceramic oxide. Additionally or alternatively, 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 of a material that causes it to emit infrared radiation in the range of approximately 1 μm to 100 μm. The infrared radiation may heat the fluid in the inner cavity of the box. Infrared heating may be the only heat source. Alternatively, infrared radiation may be combined with another type of heater (such as a conductive heater) to heat the fluid. Using more than one heat source can improve heating efficiency and/or reduce the time to heat the fluid compared to using a single heat source. The controller of the looper 20 can be used to adjust the heating time and the sequence of pumping and gate action within the box 40 so that an optimized sequence can be achieved.

As shown in FIG3 , the heating plate 32 is coated with a ceramic material 32a that is suitable for increasing the intensity of infrared heating that can be applied to the fluid in the box cavity 44. By heating the fluid in the inner cavity 44 of the box 40, the efficiency of the device can be improved because the heating and pumping actions can occur sequentially or simultaneously and in the same location. This arrangement makes the design of the device simpler with reduced components and associated cost savings. The desired heat of the fluid, such as dialysate, can be achieved by selecting the appropriate time to maintain the fluid in the inner cavity 44. For example, the fluid can be maintained for 2 seconds, 3 seconds, 4 seconds, 5 seconds, or any desired amount of time. Once the fluid is heated to the desired temperature, it can be pumped out of the box 40 toward the patient with the help of the selected gate 50A.

The above-mentioned pumping action and gate actuation are generated by the pump 70. Thus, in the APD apparatus shown in FIG. 5 , the solution or dialysate held in one of the bags 66, 67 can be pumped into and out of the inner cavity 44 of the box 40. Specifically, the pump 70 will cause a negative pressure so that the solution from one bag 66 or 67 is drawn into the inner cavity 44 of the box 40, and the appropriate selection of the gate occurs, in other words, the corresponding gate 50C, 50D is opened according to the bag 66, 67 used. The solution will then be heated in the box by the heater 32. Once heated to the desired temperature, the pump 70 generates a positive pressure to push the solution from the box toward the patient through the tube 60. In this case, the gate 50A will be opened to allow the solution to be transferred to the patient. Multiple cycles of drawing the solution into the cartridge 40 and pumping the solution out to the patient may be performed until the desired amount of solution is delivered.

In order to measure the amount of solution delivered to the patient through the tube 60, an ultrasound sensor 80 is provided. The ultrasound sensor may be a miniature ultrasound sensor that detects the flow rate of the fluid. The ultrasound sensor 80 is positioned adjacent to or around the patient tube 60. As shown in FIG5 , the tube 60 may be held in place through the center of the ultrasound sensor 80. A clamp (not shown) may be provided to hold the tube 60 in the correct position relative to the sensor 80. The clamp may be part of the housing of the ultrasound sensor 80.

The ultrasonic sensor 80 works by emitting sound waves from an emitter 81. The sound waves are then detected by a detector 82 of the ultrasonic sensor 80. The sound waves emitted and detected are ultrasonic waves. The ultrasonic transmission emitter may include a piezoelectric element. Similarly, the detector of the ultrasonic detection may include a piezoelectric element. In the embodiment shown in FIG. 5 , when the tube 60 is in a position to pass through the sensor 80, the emitter 81 of the ultrasonic 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. According to other possible embodiments, the emitter and the detector may be located on the same side of the tube, wherein the emitted sound waves will be reflected from the opposite side of the tube or a plate located at the opposite side and reflected back toward the detector. The sound waves emitted by the emitter 81 are transmitted directly through the tube 60 until they are detected by the detector 82. The characteristics of the sound waves are detected by the detector 82, and the difference in characteristics (such as frequency, direction or time) between emission and detection can be determined. The ultrasonic sensor 80 and any associated control or detection elements can be adjusted to take into account the properties of the tube, such as wall thickness, transparency, the material from which the tube is made, and the inner and/or outer diameter. The ultrasonic sensor 80 can also take into account the characteristics of the material flowing through the pipe, such as the viscosity and type of material.

The ultrasound sensor 80 is located outside of the patient tube 60. Therefore, the ultrasound sensor 80 does not affect the flow of fluid through the tube 60. The location of the sensor outside of the tube 60 will also ensure that the fluid will not be contaminated by the sensor housing.

As fluid (such as a solution or dialysate) flows through patient tube 60 toward the patient, ultrasound sensor 80 detects the flow rate of the fluid. The cumulative flow rate or total amount of fluid that has passed through tube 60 is calculated based on the flow rate measurement obtained by sensor 80. The loop meter 20 can be programmed so that once the ultrasound sensor measures that the desired amount of fluid has passed through tube 60, the loop meter can stop any additional fluid from being pumped toward the patient. The stopping action can be achieved by a combination of stopping the pumping of box 40 and closing gate 50A.

When the desired amount of fluid has been delivered to the patient, a dwell period will follow. During the dwell period, the material/dialysate in the patient's peritoneal cavity will be exchanged with waste fluid (diffusion process).

After the dwell period, the looper 20 will be used to begin pumping waste fluid or effluent away from the patient. The process for pumping effluent from the patient is similar to the process for delivering solutions to the patient. The pump 70 will provide negative pressure to the membrane 45 through the pipeline 34 with the gate 50A in the open position so that the effluent from the patient will be drawn into the inner cavity 44 of the box. During this part of the cycle, it is not necessary to heat the fluid (effluent) in the inner cavity 44. Once the inner cavity 44 is filled with effluent, the pump 70 will introduce positive pressure through the pipeline 34 to pump the effluent through the gate 50B and the port 55B through the pipe 61 and into the drainage tube/container 68. Repeated cycles of introducing negative and positive pressures and pumping effluent into and out of the cassette 40 may be performed until a desired amount of effluent fluid is withdrawn from the patient.

The ultrasonic sensor 80 can be used to detect the amount of effluent drained from the patient through the patient line 60. The flow rate of effluent through the tube 60 is detected in a manner similar to that used to detect the amount of fluid that has been delivered to the patient. The emitter 81 will emit appropriate sound waves, and the detector 82 will detect the sound waves using the generated signal indicating the flow rate of the effluent. Optionally, the emitter 81 emits sound waves of at least 20kHz, which is above the detectable range of the human ear. The accumulated flow value can be converted into the total amount of effluent drained from the patient. Once the desired total amount of effluent is calculated from the flow value, the loop meter 20 will stop the drainage process.

The ultrasound sensor emits sound waves in a frequency range above 20kHz. This range is above the range detectable by the human ear, so the sound waves do not cause any discomfort to the patient using the machine. The ultrasound sensor can emit and detect sound waves above 1MHz. Alternatively, the ultrasound sensor can emit and detect sound waves above 20MHz. The use of ultrasound sensors can be more accurate than previously used methods of detecting how much fluid has been delivered to or drained from a patient.

The device can have a speed sensor that monitors the speed of the motor of the pump 70. A voltage controller that controls the voltage supplied to the pump can also be provided, which can be used to adjust the speed of the pump motor. The speed of the pump can be adjusted to the desired level to achieve the desired positive or negative pressure. For example, if a higher amount of positive pressure is required (such as to close a gate to block the flow of fluid), the voltage controller can increase the supplied voltage to increase the positive pressure applied to the pneumatic system. The pressure generated is preferably controllable to adjust the use requirements or environment of the loop device. As an example, in a greater altitude position above sea level, the ambient pressure may be lower, so the pressure required by the pump can be adjusted accordingly. According to a preferred embodiment, the looper utilizes sensors to track usage requirements and self-regulates the voltage supplied to the pump 70 without requiring user input.

As described above, the looper 20 preferably has an internal controller/computer that will control and track the use of the looper 20 and its peripheral components. Depending on the implementation, the looper 20 will include a communication link, such as a mobile, cellular, Wi-Fi, broadband or other Internet connection, which communicates via a modem or similar device. The tracking of device usage can be used for self-diagnostic processes within the looper 20. A technician or other individual can use the communication link to communicate remotely with the looper 20. The remote link can command a self-diagnostic process to evaluate whether the looper is functioning correctly, in other words, whether the sensors, pumps, pneumatic lines, heaters, etc. are functioning. Alternatively, the looper controller/computer will automatically track the operation and can send a remote message if a problem occurs. Such a problem may be that a part needs to be replaced or will need to be replaced soon, alternatively, more serious problems such as failure of any component can be automatically and quickly communicated to a remote technician or expert. The life of various parts of the loop equipment can be calculated based on known values and calculations of usage status and effective time. The sounds generated by the looper 20 when in operation can be detected. In addition, the pipes and pipelines in the equipment can be kept monitored to locate any leaks and issue appropriate warnings. Status reports can be sent to the remote center to notify maintenance requirements, parts replacement schedules or any localized problems, and the technician can accordingly log in the appropriate time to service the looper. In most cases, the looper 20 will be located in the patient or machine user's home, so advance warning to the technician is preferred.

The present invention relates to medical devices and methods of controlling the devices. The preferred embodiments described herein relate to automated peritoneal dialysis devices and related methods and systems. However, it will be clear to those skilled in the art that various aspects of the present invention may be more broadly applicable to devices and methods beyond the preferred embodiments described herein.

10:APD equipment

20: Loop Meter

22: Switch

23: Display screen

24: Camera

26: Front panel

27: Hinge

28: Rotating arm

29: Handle

60: Patient management

61: Drainage tube

62: First solution tube

63: Second solution tube

64: First adapter

65: Second adapter

66: First solution bag

67: Second solution bag

68: Drainage tube/container

80:Ultrasonic sensor

81: Transmitter

82: Detector

Claims (40)

A medical device comprising: a fluid conduit; an ultrasound sensor positioned adjacent to the fluid conduit and adapted to emit and detect sound waves passing through the fluid conduit; and a device for pumping fluid through the fluid conduit, wherein the ultrasound sensor is adapted to detect a flow rate of the fluid passing through the fluid conduit, the flow rate being used to calculate a volume of fluid pumped through the fluid conduit, wherein the medical device is an automated peritoneal dialysis (APD) machine. The medical device according to claim 1, wherein the ultrasonic sensor includes an ultrasonic transmitter and an ultrasonic detector, and the ultrasonic transmitter is suitable for transmitting ultrasonic waves so that the ultrasonic waves pass through the fluid conduit and are transmitted through the fluid in the fluid conduit, and the ultrasonic detector is suitable for receiving the ultrasonic waves. The medical device according to claim 2, wherein the ultrasonic emitter is located on a first side of the fluid conduit, and the ultrasonic detector is located on a second side of the fluid conduit opposite to the first side, so that the fluid can pass through the fluid conduit between the ultrasonic emitter and the ultrasonic detector. The medical device according to claim 2, wherein the ultrasonic transmitter and the ultrasonic detector each include a piezoelectric element. A medical device according to claim 1, wherein the ultrasonic sensor emits and detects ultrasonic waves with a frequency of at least 20 MHz. The medical device of claim 1, wherein the fluid conduit is adapted to be connected between the APD machine and the patient, and wherein the ultrasound sensor is adapted to calculate the volume of fluid delivered to the patient and/or the volume of fluid drained from the patient. The medical device of claim 1, wherein the ultrasound sensor is part of an element including a recessed area adapted to receive the fluid conduit. The medical device according to claim 7 includes a device for firmly holding the fluid conduit in the recessed area. The medical device according to claim 1 comprises: a housing; a box adapted to be received in a receiving area of the housing, the box comprising at least one membrane; at least one gas conduit; and a pressure source; wherein the at least one membrane is in communication with at least one fluid in the at least one gas conduit, wherein the pressure source is adapted to apply positive and/or negative pressure through the at least one gas conduit to control the movement of the at least one membrane, wherein the box comprises an inner cavity adapted to receive the fluid, wherein the inner cavity is adjacent to the membrane in the at least one membrane on at least one side, and wherein the application of positive and/or negative pressure to the membrane causes the fluid to move into or out of the inner cavity, which provides a means for pumping the fluid through the fluid conduit. A medical device according to claim 9, wherein the movement of the at least one membrane comprises movement toward or away from the opening of the at least one gas conduit, depending on whether the applied positive pressure and/or negative pressure is positive or negative. The medical device of claim 9 further comprises a fluid gate having an open position and a closed position, wherein the movement of the membrane toward or away from the gas conduit determines whether the fluid gate is in the open position or in the closed position. The medical device according to claim 11 comprises a plurality of the gas conduits, a plurality of the membranes and a plurality of the gates, wherein each of the gates has a corresponding open position and a corresponding closed position, and wherein the application of the positive pressure and/or negative pressure controls the corresponding movement of the membrane to determine which of the gates are in the corresponding open position and the corresponding closed position. A medical device according to claim 12, wherein each conduit includes a valve adapted to determine whether the pressure source is able to apply the positive pressure and/or negative pressure to the corresponding membrane through the conduit. The medical device according to claim 12 comprises: at least one first gate to control the flow of fluid from a fluid source; a second gate to control the flow of the fluid to a patient; and a third gate to control the flow of the fluid to a drainage tube or a container. A medical device according to claim 11, wherein the box includes the one or more gates. The medical device according to claim 9 further comprises: at least one first fluid conduit, which is suitable for transferring a first fluid from a fluid source to the inner cavity of the box; a second fluid conduit, which is suitable for transferring the first fluid from the inner cavity to a patient and/or transferring a second fluid from a patient to the inner cavity; and a third fluid conduit, which is suitable for transferring the second fluid from the inner cavity to a drainage tube or a container. The medical device according to claim 16, wherein the at least one first gate is suitable for controlling the flow of the first fluid through the at least one first conduit, the second gate is suitable for controlling the flow of the first fluid and/or the second fluid through the second fluid conduit, and the third gate is suitable for controlling the flow of the second fluid through the third fluid conduit. The medical device of claim 9, wherein the housing includes a heater positioned adjacent to the receiving area, the heater being adapted to heat the fluid within the inner cavity of the box. The medical device according to claim 18, wherein the heater is a heating plate, preferably cylindrical or disc-shaped. The medical device according to claim 18, wherein the duration for which the fluid in the inner cavity of the box is heated by the heater is adjusted based on the ambient temperature. The medical device of claim 18, wherein the application of positive and/or negative pressure to the membrane pumps the fluid into and out of the inner cavity via a pumping action, and wherein the pumping action is performed simultaneously with heating the fluid. The medical device according to claim 18, wherein the heater is made of one or more of the following materials: ceramic, ceramic oxide, metal, metal oxide, and metal coated with ceramic or ceramic oxide. The medical device of claim 18, wherein the gas conduit passes through a hole in the heater to control movement of the membrane toward or away from the heater. A medical device according to claim 9, wherein the pressure source is a dual-head pump suitable for providing both the positive pressure and the negative pressure. A medical device according to claim 24, wherein the dual-head pump controls the actuation of a gate or gates according to any one of claims 3 to 7, and the movement of fluid into and out of the inner cavity of the box according to any one of claims 9 to 24. The medical device according to claim 16, wherein the ultrasound sensor is suitable for measuring the volume of the first fluid and/or the second fluid passing through the second conduit. The medical device according to claim 16, wherein the first fluid is dialysate and the second fluid is effluent. The medical device according to claim 1 further comprises: a plurality of ports, the ports comprising at least a first port and a second port; and a plurality of tubes, the tubes comprising at least a first tube and a second tube, wherein the first port comprises a first indicator, the first tube comprises a corresponding first indicator, the second port comprises a second indicator, and the second tube comprises a corresponding second indicator, and wherein the first indicator and the second indicator and the corresponding first indicator and the corresponding second indicator are selected so as to guide the user to connect the first tube to the first port, and guide the user to connect the second tube to the second port. A medical device according to claim 28, wherein the first indicator and the second indicator and the corresponding first indicator and the corresponding second indicator are visual indicators. The medical device of claim 29, wherein the visual indicator includes a color code that guides a user to connect a tube of a first color to a port of the first color and to connect a tube of a second color to a port of the second color. A medical device according to claim 28, wherein each indicator is provided in the form of a colored light, and wherein the first indicator is a first color light, wherein the corresponding first indicator is a corresponding first color, wherein the second indicator is a second color light, and wherein the corresponding second indicator is a corresponding second color. A medical device according to claim 28, wherein the box includes each of the ports. The medical device according to claim 28 further comprises: a housing; a box adapted to be received in a receiving area of the housing, the box comprising at least one membrane; at least one gas duct; and a pressure source; wherein the at least one membrane is in communication with at least one fluid in the at least one gas duct, wherein the pressure source is adapted to apply positive and/or negative pressure through the at least one gas duct to control the movement of the at least one membrane, wherein the box comprises an inner cavity adapted to receive the fluid, wherein the inner cavity is adjacent to the membrane in the at least one membrane on at least one side, and wherein the positive and negative pressures are applied to the membrane by the positive and/or negative pressures. The application of pressure and/or negative pressure to the membrane causes the fluid to move into or out of the lumen, which provides a means for pumping fluid through the fluid conduit and wherein the plurality of conduits include at least one first fluid conduit adapted to transfer a first fluid from a fluid source to the lumen of the cassette; a second fluid conduit adapted to transfer the first fluid from the lumen to a patient and/or a second fluid from a patient to the lumen; and a third fluid conduit adapted to transfer the second fluid from the lumen to a drain or container. A method for detecting the flow of fluid through a fluid conduit of a medical device, the method comprising the following steps: providing a medical device according to any one of claims 1 to 33; providing an ultrasonic sensor adjacent to the fluid conduit; allowing fluid to pass through the fluid conduit; using the ultrasonic sensor to measure the flow rate of the fluid passing through the fluid conduit; and using the measured flow rate to calculate the total amount of the fluid passing through the fluid conduit, wherein the medical device is an automated peritoneal dialysis machine. The method according to claim 34, wherein the ultrasonic sensor includes an ultrasonic transmitter and an ultrasonic detector, and wherein the method includes the following steps: emitting ultrasonic waves from the ultrasonic transmitter so that the ultrasonic waves pass through the fluid conduit and are transmitted through the fluid in the fluid conduit and are received by the ultrasonic detector. The method according to claim 35, wherein the ultrasonic emitter is located on a first side of the fluid conduit, and the ultrasonic detector is located on a second side of the fluid conduit opposite to the first side, so that the fluid passes through the fluid conduit between the ultrasonic emitter and the ultrasonic detector. The method according to claim 35, wherein the ultrasonic transmitter and the ultrasonic detector each include a piezoelectric element. The method according to claim 34 further includes the following step: stopping the flow of the fluid through the fluid conduit when the calculated total amount of fluid reaches or exceeds a predetermined value. A method according to any one of claims 34 to 38, wherein the fluid is a dialysate, wherein the method comprises the steps of delivering the dialysate to a patient via the fluid conduit, and wherein the calculated total amount of fluid passing through the fluid conduit is related to the total amount of dialysate delivered to the patient. The method of any one of claims 34 to 38, wherein the fluid is an effluent, wherein the method comprises the steps of draining the effluent from the patient through the fluid conduit, and wherein the calculated total amount of fluid passing through the fluid conduit is related to the total amount of effluent drained from the patient.

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