Patent ID: 12259268

DETAILED DESCRIPTION

Unless defined otherwise, all technical and scientific terms used have the same meaning as commonly understood by one of ordinary skill in the art.

The articles “a” and “an” are used to refer to one to over one (i.e., to at least one) of the grammatical object of the article. For example, “an element” means one element or over one element.

To “associate” means to identify one piece of information as related to a second piece of information.

A “capacitor” is an arrangement of elements within an electric circuit that hold an electric charge. Each capacitor includes a pair of conductive plates and has a characteristic capacitance.

The terms “communication,” “communicate,” “communicating,” and the like can refer to the ability to transmit electronic data, instructions, information wirelessly, via direct electrical connection, or any other electrical transmission means between one or more components.

The term “compare” means to determine whether two files or data are the same or different.

The term “comprising” includes, but is not limited to, whatever follows the word “comprising.” Use of the term indicates the listed elements are required or mandatory but that other elements are optional and may be present.

A “conductive plate” is any element that acts as a capacitor within a circuit. No particular limits or thresholds to conductance are required for a component to be a “conductive plate,” provided that the element acts as a capacitor.

The term “consisting of” includes and is limited to whatever follows the phrase “consisting of.” The phrase indicates the limited elements are required or mandatory and that no other elements may be present.

The term “consisting essentially of” includes whatever follows the term “consisting essentially of” and additional elements, structures, acts or features that do not affect the basic operation of the apparatus, structure or method described.

The term “device,” as used herein, refers to any device that can authenticate a user or USB authentication device.

The term “determining” or to “determine” refers to ascertaining a particular state of a component or system.

The term “device” is to be interpreted in the broadest and can include anything made for a particular purpose, a contrivance of any type, particularly a mechanical or electrical component or hardware. Some examples of devices can include a medical device such as a dialysis machine, laptop, computer, computer peripherals of any type, computer terminals, portable devices, smart phones, and smart watches.

A “dialysis system” is a collection of medical devices used to provide dialysis treatment of any type including hemodialysis, peritoneal dialysis, ultrafiltration and hemodiafiltration and the like to one or more patients.

The term “execute” means to perform a step or series of steps.

The term “fluid communication” means that two chambers are connected, either directly or indirectly, with or without intervening elements such as valves, membranes, stoppers, or the like, so that fluid flows from one chamber into another. Chambers are in “fluid communication” whether or not the fluid flows in both directions.

A component is “intrusive” if the component is positioned within a chamber for holding or transporting liquid such that the component will come in physical contact with the liquid.

The term “medical device” refers to a device used to perform medical treatment or diagnosis of any type.

To “measure” is to determine a quantifiable property of a component or system via a sensor.

The term “non-intrusive” describes any system, device, or component if any feature of the system, device, or component used to implement the method are positioned outside of the chambers where liquid is transported and stored so that none of the components come in physical contact with the measurand, such as a liquid.

A “peritoneal dialysis system” is a collection of medical devices used to provide peritoneal dialysis treatment to a patient.

The term “peritoneal dialysis fluid” refers to the mixture that is injected into a patient during peritoneal dialysis treatment. When properties of peritoneal dialysis fluid are described herein, such as its dielectric properties and permittivity, they refer to the properties of the fluid before its use in treatment.

The term “programmed” can mean a series of instructions that cause a device or system to perform certain steps.

The term “receiving” refers to the process of obtaining electronic information by any means.

An “RF transmission line” is a path between an RF transmitter and an RF receiver over which a radio frequency signal is transmitted. The path need not be a straight line between the components. Reflection, refraction, induction, and other effects that modify the RF signal during its transmission are part of the RF transmission line.

The term “sending” refers to the process of transmitting electronic information to be received.

A “sensor” is a device configured to determine a particular state of a component, substance, or component whether in a system or not. For example, a sensor can measure a liquid, a flow rate, and the like.

A “signal” is a distinct arrangement of data, matter, and/or energy sent over a medium by a transmitter that is recognized by a receiver. Transmitted energy is a “signal” regardless of whether the energy includes any particularized data.

Non-Intrusive Flow Sensor

FIG.1shows a container101disposed within a flow path for a liquid102. Liquid moves from an inlet103to an outlet104; the outlet is blocked by a valve105that can be selectively opened to allow the liquid102to be dispensed or held in the container. To measure the volume of liquid102in the container101, a pair of conductive plates106and107can be placed adjacent the container101but outside the walls so as not to contact the liquid102. The conductive plates106and107are non-intrusive with respect to the flow of the liquid102in the container101: they do not physically contact the liquid102or divert the fluid path. The plates106and107can form a capacitor within a circuit which has additional components such that the capacitance between the two plates106,107, can be accurately measured; for instance, the circuit can include a resistor and/or inductor of known electrical properties. When a known quantity of current is passed through the circuit, the change in voltage will be proportional to the capacitance between the plates, thus providing that measurement to the circuit.

FIG.2illustrates a sensor embodiment in which the conductive plates206and207forms the RF waveguide which act as a level sensor, The RF transmitter, receiver, and wave guide and liquid medium filled between the waveguide plates form parts of a circuit capable of generating an RF signal and then measuring the loss when the signal is received, thus allowing measurement of the impedance across the RF transmission line.

FIG.3illustrates a sensor embodiment in which a single RF wave guide made of parallel conductor plates306acts as a level sensor, measuring a reflected signal by means of reflectometry included in the sensor circuit. As with the two-conductor waveguide system above, the circuit generates an RF signal and then measures the loss when the signal is received, thus allowing measurement of the impedance across the RF transmission line.

Because water and aqueous solutions have significantly different dielectric properties than air, the measured capacitance or impedance can be used to calculate the volume of liquid found in the container through which the signal is transmitted. For example, parallel conductive plates have a characteristic capacitance of:
C=ε0*εr*A/d

Where A and d are the area of and distance between the plates and ε0is the permittivity of the free space between the plates and εr is the permittivity of water. Since εrof water is >>ε0, the capacitance of the level sensor can be approximated to capacitance formed because of level of water.

Knowing the geometry of the sensor elements and the dielectric properties of the liquid, the change in the volume of the liquid can be determined based on detecting a change in the capacitance:
ΔVliquid=ΔC

The impedance of an RF wave can be similarly determined wherein impedance depends on the permittivity of the medium as well, particularly:
Z2=μ/ε

For the impedance Z of a wave travelling through a non-conductive medium of permeability μ and permittivity ε. For water and other aqueous substances with negligible magnetic properties (those that have a relative permeability μ of approximately 1), the permeability of free space can be used. For a change in the volume of liquid in the container, then, the change of impedance would be:
ΔZ=√(μ0(εair−εliquid)ΔV[ε2−(εair−εliquid)ΔV])

which, in cases where the change in permittivity due to the change in volume would represent a small portion of the overall permittivity of the space, approximates to:
ΔZ=√(μ0(εair−εliquid)ΔV)/ε

Therefore, if the overall permittivity ε of the transmission line is known, as well as the difference in permittivity between the liquid in the container and the air, a change in volume can be calculated as proportional to the square of the change in impedance:
ΔV=ΔZ2*ε2/(μ0(εair−εliquid))

These equations can therefore be used to find V, the amount of liquid in the container, or ΔV, the amount of water entering or leaving the container. If measurements are recorded and taken over time, a rate of change of the volume, representing a flow rate either into or out of the container, could also be calculated.

FIGS.4and5are component diagrams showing a dialysis system400that includes a non-intrusive flow sensor as described herein. Components can be connected by double lines to show fluid communication. A dialysis system controller's electronic communication connection is illustrated by dotted lines; the dialysis system controller401sends control signals to many components as well as receiving data from a sensor circuit402.

As shown, water passes from a water source403to a water purifier404. The water source403can represent pretreated water, and part of the function of the water purifier404can be assuring that water received from the water source403is suitable for purification by the system. In some embodiments, the water source403can be a commercially or residentially available water supply, such as tap water. The dialysis system controller401can send control signals to the water purifier404and can also receive signals when certain operations, such as a water purification process, have completed.

Purified water can be held in a water container405, which as described above can include an outlet valve406to regulate when and at what rate the water is dispensed. The water container405can be made of any appropriate material and can be rigid or deformable. In some embodiments, the container405can be a fully modular component of the system400, so that a user can swap a damaged or malfunctioning container with a similar container.

Water dispensed from the container405enters a mixer407where the water is combined with additives from an additives source408to form a dialysis fluid. Where the dialysis system400is used for peritoneal dialysis, the fluid mixer407is calibrated to produce a peritoneal dialysis fluid appropriate for injection into a patient as part of a peritoneal dialysis procedure. The dialysis system controller401sends instructions to the mixer407to create fluid, which can depend on the rate at which water is dispensed from the water container405.

The peritoneal dialysis fluid is stored in a fluid container409, which can again have an outlet valve410controlled by the dialysis system controller401to determine when and at what rate the fluid is dispensed. The properties of the fluid container409can be similar to those of the water container405or can vary according to the different needs of the two steps in the treatment process; for instance, the overall capacity of the containers can be different, they can be of different geometries to accommodate other components of the device, or they can be made of the different materials to best hold their associated liquid. Upon operation of the valve410by the dialysis system controller401, the peritoneal dialysis fluid is dispensed to injection components411in accordance with the dialysis treatment.

As shown inFIG.4, the sensor circuit402can be in communication with a transmitter element412and receiver element413for sending a signal414through the water container405to measure the dielectric properties of the container. The measurements taken by the sensor circuit402(which can include capacitance and/or impedance, as described above, but may also include further quantities depending on the specific construction of the circuit, such as inductance, voltage, current, resistance, signal strength, signal frequency, and/or others) are communicated to the dialysis system controller401to determine the volume of the water container405.

Many components of electrical circuits known in the art can be included in the sensor circuit402. For example, a bandpass filter415can be included in the sensor circuit402, isolating the signal414from signals outside the passband permitted by the filter. Furthermore, any suitable operational amplifier416can be used to boost the received signal to ensure that a usable measurement reaches the dialysis system controller401.

Similar elements are shown inFIG.5, except that the sensor circuit402is shown around the fluid container409. The permittivity and other dielectric properties of peritoneal dialysis fluid, rather than of water, will be used to calculate the volume of water available in the container409. Any of the circuitry components discussed above can be used to support the measurement process for the sensor circuit402. The volume of fluid in the container, and/or the flow rate into and out of the container, can be used in determining when and at what rate to dispense the peritoneal dialysis fluid to the injection components411.

AlthoughFIGS.4and5illustrate alternative embodiments in which a sensor circuit402is deployed at one of two containers, in another embodiment, multiple sensor circuits could be used to measure multiple containers within the same system. The sensors could be the same or could vary one from another, including any of the variations described herein or understood in the art. Any number of sensor circuits could be in communication with the same or multiple different controllers of a medical treatment system to best monitor and operate the devices.

Usage of Non-Intrusive Flow Sensor

FIG.6is a flow chart showing a method for controlling a dialysis system in conjunction with non-intrusive flow sensors as described herein. As briefly described above, this method describes steps in which both a water container and a fluid container are measured by flow sensors; either of these steps could be taken without the others in the case where only one of the sensor circuits is employed or currently active.

In step601, the water purifier is activated. This can involve receiving water from a water source, which can be pumped or otherwise controlled. The purifier dispenses water into a water container, where the water is held for controlled dispensation during subsequent steps.

In step602, a first signal is sent and received from a sensor circuit positioned to monitor the water container. Then, in step603, the system controller calculates the volume of the water from the measurements associated with the sent/received signals. In some embodiments, this monitoring process can begin as soon as the dialysis system begins and can continue if there is water left to purify and/or store in the water container. The calculated water volume can include, not only the approximate total volume in the container, but also the rate at which the container is gaining water from the purifier.

In step604, the system dispenses water from the container. The timing and flow rate of the water dispensed from the water container can depend on the quantities calculated in steps603, above. When sufficient water is dispensed, in step605, the system can activate the mixer. Properly mixed dialysis fluid, produced from rates regulated by the system controller, enters the dialysis fluid container from the mixer during this step.

Steps606and607comprise a second set of monitoring steps positioned at the fluid container. These steps can begin with the original activation of the device or with activation of the mixer and can continue if sufficient fluid remains in the fluid container to measure the volume and/or flow. Again, the calculated volume can include flow quantities as well as total volume of fluid available, and the calculations of step607consider the dielectric properties of the fluid mixture as they differ from water.

In step608, the system dispenses fluid from the dialysis fluid container, which can depend on the calculated rates of flow and/or total volume available in the container. In step609, the quantity and rate of available fluid can also determine when and how the injection components are operated by the system controller. For example, injection rates can be limited based on how much fluid is calculated to be ready for injection, and the system cannot begin certain steps of treatment at all until sufficient quantities of fluid are available.

One skilled in the art will understand that various combinations and/or modifications and variations can be made in the described systems and methods depending upon the specific needs for operation. Various aspects disclosed herein can be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. Moreover, features illustrated or described as being part of an aspect of the disclosure can be used in the aspect of the disclosure, either alone or in combination, or follow a preferred arrangement of one or more of the described elements. Depending on the example, certain acts or events of any of the processes or methods described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., certain described acts or events cannot be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as performed by a single module or unit for purposes of clarity, the techniques of this disclosure can be performed by a combination of units or modules associated with, for example, a device.