Smart peritoneal dialysis device

Abstract

An apparatus for monitoring and / or modifying peritoneal dialysis treatment is provided. [Solution] The device includes a memory that stores at least one treatment protocol and a control circuit connected to the memory, the control circuit generating a report and / or modifying the treatment if the results of the treatment are not the desired results of the treatment protocol.

Description

Technical Field

[0001] Related Applications This application claims the benefit of priority of PCT Patent Application No. PCT / IL2017 / 050117, filed on February 1, 2017, the entire content of which is incorporated herein by reference.

[0002] In addition, this application claims the benefit of priority under 35 USC § 119(e) of U.S. Provisional Patent Application No. 62 / 488,944, filed on April 24, 2017, the entire content of which is incorporated herein by reference.

[0003] The present invention, in some of its embodiments, relates to an apparatus for dialysis treatment, and more specifically, but not exclusively, to an apparatus for monitoring peritoneal dialysis treatment.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Peritoneal dialysis is a life-saving technique for removing waste products and excess water from the blood. It is mainly used to maintain the health of patients with kidney failure. Although peritoneal dialysis may seem like a simple process, many of its effects on the body are not fully understood. This lack of knowledge translates into questions about whether the therapy a patient receives is being delivered in an optimal manner.

[0005] Peritoneal dialysis uses the peritoneum as a natural semi-permeable membrane to remove waste products and excess water from the blood in the body. The waste products and excess water move from the blood through the peritoneum into the abdominal cavity, and more specifically, into a special dialysis solution called dialysate in the peritoneal cavity. The waste products to be removed include uremic waste products, excess water, and excess minerals. Urea clearance is a major indicator of the adequacy of dialysis. The urea level in the used dialysate gives a good estimate of the performance of the dialysis session.

Means for Solving the Problems

[0006] Some examples of some embodiments of the present invention are listed below.

[0007] Example 1. An apparatus for monitoring and / or modifying peritoneal dialysis treatment, a memory storing at least one treatment protocol, a control circuit connected to the memory, comprising, wherein the control circuit generates a report and / or modifies the treatment when the result of the treatment is not the desired result of the treatment protocol.

[0008] Example 2. The apparatus according to Example 1, further comprising an interface, wherein the interface delivers a warning to a patient and / or a caregiver based on the report.

[0009] Example 3. The apparatus according to Example 2, further comprising tubing shaped and sized to flow fluid to a catheter, wherein the control circuit modifies the treatment based on the flow of the fluid and / or based on the fluid contents within the tubing.

[0010] Example 4. The apparatus according to Example 3, comprising a pump rotor associated with the tubing, the pump rotor being configured to move the fluid, wherein the control circuit modifies the treatment by modifying the rotation of the pump rotor.

[0011] Example 5. The apparatus according to Examples 3 and 4, comprising at least one test path fluidly connected to the tubing, the test path being shaped and sized to flow at least a portion of the fluid from the tubing to the test path.

[0012] Example 6. The apparatus according to Example 5, comprising at least one optical sensor connected to the control circuit for measuring the characteristics of light passing through the fluid within the test path.

[0013] Example 7. The apparatus according to Example 5, comprising at least one color scale proximal to the test path for visually analyzing the color of the fluid within the test path.

[0014] Example 8. The apparatus according to Example 2, comprising at least one clinical sensor connected to the control circuit for sensing at least one patient clinical parameter, wherein the result of the treatment is a clinical result indicated by the patient clinical parameter.

[0015] Example 9. The apparatus according to Example 8, wherein the patient clinical parameter is selected from the list consisting of heart rate, blood pressure, and / or body weight.

[0016] Example 10. The apparatus according to Example 8 or Example 9, wherein when the patient clinical parameter is not within a desired range of values, the control circuit issues a signal to the interface to generate a warning to the patient and / or caregiver.

[0017] Example 11. The apparatus according to any one of Examples 8 to 10, further comprising a communication circuit for transmitting an instruction to a physician when the patient clinical parameter is not within a desired range of values.

[0018] Example 12. The apparatus according to any one of Examples 8 to 11, wherein the memory stores the values of the patient clinical parameters.

[0019] Example 13. The apparatus according to any one of Examples 8 to 12, wherein when the patient clinical parameter is not within a desired range of values, the control circuit modifies the treatment, or modifies at least one treatment parameter, or selects a different treatment protocol stored in the memory.

[0020] Example 14. The apparatus according to Example 13, wherein the at least one modified treatment parameter includes the dwell time of the dialysate to be infused, the treatment duration, and / or the composition.

[0021] Example 15. The apparatus according to any one of Examples 8 to 14, wherein the control circuit issues a signal to the interface to indicate which dialysate bag to select or which dialysate bag to provide to the user.

[0022] Example 16. The apparatus according to Example 3, further comprising at least one clinical sensor connected to the control circuit for measuring the chemical composition of the dialysate fluid in the tubing.

[0023] Example 17. The apparatus according to Example 16, wherein the clinical sensor measures the ionic strength of the dialysate fluid and / or the dextrose level and / or the urea level and / or the creatinine level in the dialysate fluid.

[0024] Example 18. The apparatus according to any one of Example 16 or Example 17, wherein when the chemical composition is not within the desired value range, the control circuit issues a signal to the interface to generate a warning indication.

[0025] Example 19. The apparatus according to any one of Examples 16 to 18, further comprising a communication circuit for transmitting an instruction to a physician when the chemical composition is not within the desired value range.

[0026] Example 20. The apparatus according to any one of Examples 16 to 19, wherein when the chemical composition is not within the desired value range, the control circuit modifies the treatment, or modifies at least one treatment parameter, or selects a different treatment protocol.

[0027] Example 21. The apparatus according to Example 20, wherein the at least one modified parameter of the treatment includes the dwell time of the dialysate to be infused, the treatment duration, and / or the composition.

[0028] Example 22. The apparatus according to Example 1, further comprising at least one sensor for measuring the biological and / or chemical and / or physical properties of the dialysate discharged during the discharge process, and the control circuit detects peritonitis based on the measured properties of the discharged dialysate.

[0029] Example 23. The device according to Example 22, further comprising an interface for delivering instructions to a patient and / or a caregiver, wherein when the peritonitis is detected, the control circuit issues a signal to the interface to generate a warning instruction.

[0030] Example 24. The device according to Example 23, further comprising a communication circuit, wherein the communication circuit transmits the warning instruction to a doctor.

[0031] Example 25. The device according to any one of Examples 22 to 24, wherein when the peritonitis is detected, the control circuit modifies at least one parameter of the treatment protocol or selects an alternative treatment protocol stored in the memory.

[0032] Example 26. The device according to any one of Examples 22 to 25, wherein the biological characteristic includes the number of white blood cells in the drained dialysate.

[0033] Example 27. The device according to any one of Examples 22 to 26, wherein the physical characteristic includes the turbidity level of the drained dialysate.

[0034] Example 28. The device according to any one of Examples 22 to 27, wherein the sensor is an optical sensor configured to measure the optical density of the drained dialysate at at least one wavelength.

[0035] Example 29. A method for modifying peritoneal dialysis treatment based on the content of the drained dialysate using a device, comprising: measuring, by at least one sensor or a manual indicator of the device, at least one parameter related to the content of the drained dialysate; modifying the treatment based on the at least one parameter of the measurement; and including.

[0036] Example 30. The method according to Example 29, comprising detecting peritonitis based on the at least one parameter of the measurement.

[0037] Example 31. The method according to Example 30, comprising treating the peritonitis based on the detection.

[0038] Example 32. The method according to Example 31, wherein the treating comprises instructing a user of the device to add an antibiotic to a dialysate bag.

[0039] Example 33. The method according to Example 32, wherein the treating comprises switching the dialysate bag to a bag containing an antibiotic.

[0040] Example 34. The method according to any one of Examples 29 to 33, wherein the at least one parameter is a parameter related to inflammation.

[0041] Example 35. The method according to Example 34, wherein the parameter related to inflammation comprises a turbidity level of the discharged dialysate.

[0042] Example 36. The method according to Example 34, wherein the parameter related to inflammation comprises a level of white blood cells and / or bacteria in the discharged dialysate.

[0043] Example 37. The method according to Example 34, wherein the parameter related to inflammation comprises a level of pro-inflammatory cytokines in the discharged dialysate.

[0044] Example 38. The method according to any one of Examples 31 to 37, wherein the modifying comprises injecting an antibiotic solution into the peritoneal cavity.

[0045] Example 39. The method according to Example 30, wherein the modifying comprises ending the treatment.

[0046] Example 40. The method according to Example 29, comprising determining a peritoneal dialysis treatment effect based on a value of the at least one parameter measured.

[0047] Example 41. The method according to Example 40, wherein the at least one parameter includes the dextrose level of the drained dialysate.

[0048] Example 42. The method according to Example 40 or 41, wherein the at least one parameter includes the creatinine level of the drained dialysate.

[0049] Example 43. The method according to any one of Examples 40 to 42, wherein the at least one parameter includes the urea level of the drained dialysate.

[0050] Example 44. The method according to any one of Examples 40 to 43, wherein modifying includes increasing the dwell time of the dialysate in the peritoneal cavity when the effect is lower than the desired effect.

[0051] Example 45. The method according to any one of Examples 40 to 44, wherein modifying includes decreasing the dwell time of the dialysate in the peritoneal cavity when the effect is greater than the desired effect.

[0052] Example 46. The method according to any one of Examples 40 to 45, wherein modifying includes increasing the dextrose level of the injected dialysate.

[0053] Example 47. The method according to any one of Examples 40 to 46, wherein when the effect is not the desired effect, delivering an instruction to the patient and / or caregiver is included.

[0054] Example 48. The method according to any one of Examples 40 to 46, wherein when the effect is not the desired effect, sending an instruction to a physician is included.

[0055] Example 49. A method for modifying a peritoneal dialysis treatment protocol having at least one parameter using a device, measuring at least one result of the peritoneal dialysis treatment during the treatment by the device; determining whether the at least one result is a desired result; modifying, by the apparatus, the at least one treatment parameter when the result is not a desired result according to the determination; A method comprising:

[0056] Example 50. The method according to Example 49, wherein the at least one result includes a clinical result.

[0057] Example 51. The method according to Example 50, wherein the at least one clinical result includes the volume of the dialysate discharged, and the modifying includes modifying the dwell time of the dialysate and / or the content of the dialysate based on the volume of the dialysate discharged.

[0058] Example 52. The method according to Example 50, wherein the at least one clinical result includes the chemical and / or biological content of the dialysate discharged, and the modifying includes modifying the dwell time of the dialysate and / or the content of the dialysate based on the content of the dialysate discharged.

[0059] Example 53. The method according to Example 50, wherein the at least one clinical result includes the ionic strength of the dialysate discharged, and the modifying includes modifying the dwell time of the dialysate and / or the dextrose level of the dialysate based on the ionic strength of the dialysate discharged.

[0060] Example 54. The method according to any one of Examples 49 to 53, further comprising receiving an input related to a user of the apparatus, the input including the user's clinical input and / or an input related to the operation of the apparatus by the user.

[0061] Example 55. The method according to Example 54, wherein the input includes an input related to the operation of the apparatus by the user.

[0062] Example 56. The method according to Example 55, wherein the determining includes determining whether the operation of the apparatus based on the input conforms to a determined treatment protocol.

[0063] Example 57. The method according to Example 56, comprising generating a treatment compliance report based on the determination.

[0064] Example 58. The method according to Example 57, comprising transmitting the treatment compliance report to a physician or an expert.

[0065] Example 59. The method according to any one of Examples 56 to 58, comprising warning the user when the operation of the device does not conform to the determined treatment protocol.

[0066] Example 60. A removable unit of a peritoneal dialysis device, a removable housing, and tubing having two openings shaped and dimensioned to be partially associated with a pump rotor within the housing, and at least two connectors, wherein each of the two connectors is connected to the tubing at one of the two openings, and the two connectors are fixed to the same side of the housing.

[0067] Example 61. The unit according to Example 60, wherein at least one of the two connectors is a disinfection connector, and the tubing comprises a disinfection fluid proximal to the disinfection connector.

[0068] Example 62. The unit according to Example 61, wherein the disinfection connector comprises at least one foil shaped and dimensioned to be broken by an external connector.

[0069] Example 63. The unit according to any one of Examples 60 to 62, comprising at least two flow regulators surrounding the tubing near the connectors, the flow regulators being shaped and dimensioned to allow fluid to flow between the tubing and the connectors.

[0070] The following are some further examples of some embodiments of the present invention.

[0071] Example 1. An apparatus for monitoring and / or modifying peritoneal dialysis treatment, a memory storing at least one treatment protocol, a control circuit connected to the memory, comprising, wherein the control circuit generates a report and / or modifies the treatment when the result of the treatment is not the desired result of the treatment protocol.

[0072] Example 2. The apparatus according to Example 1, further comprising an interface, wherein the interface delivers a warning to a patient and / or a caregiver based on the report.

[0073] Example 3. The apparatus according to Example 2, further comprising tubing shaped and sized to flow fluid to a catheter, wherein the control circuit modifies the treatment based on the flow of the fluid and / or based on the fluid contents within the tubing.

[0074] Example 4. The apparatus according to Example 3, comprising a pump rotor associated with the tubing, the pump rotor being configured to move the fluid, wherein the control circuit modifies the treatment by modifying the rotation of the pump rotor.

[0075] Example 5. The apparatus according to any one of Examples 3 and 4, comprising at least one test path fluidly connected to the tubing, the test path being shaped and sized to flow at least a portion of the fluid from the tubing to the test path.

[0076] Example 6. The apparatus according to any one of Examples 3 to 5, comprising at least one optical sensor connected to the control circuit for measuring the characteristics of light passing through the fluid within the tubing.

[0077] Example 7. The apparatus according to Example 5, comprising at least one color scale proximal to the test path for visually analyzing the color of the fluid within the test path, the color scale including the color of the dialysate or an indication thereof.

[0078] Example 8. The apparatus according to Example 2, comprising at least one clinical sensor connected to the control circuit for sensing at least one patient clinical parameter, the result of the treatment being a clinical result indicated by the patient clinical parameter.

[0079] Example 9. The apparatus according to Example 8, wherein the patient clinical parameter is selected from the list consisting of heart rate, blood pressure, and / or body weight.

[0080] Example 10. The apparatus according to any one of Example 8 or Example 9, wherein when the patient clinical parameter is not within a desired range of values, the control circuit issues a signal to the interface to generate a warning to the patient and / or caregiver.

[0081] Example 11. The apparatus according to any one of Example 8 to Example 10, further comprising a communication circuit for transmitting an instruction to a physician when the patient clinical parameter is not within a desired range of values.

[0082] Example 12. The apparatus according to any one of Example 8 to Example 11, wherein the memory stores the values of the patient clinical parameters.

[0083] Example 13. The apparatus according to any one of Example 8 to Example 12, wherein when the patient clinical parameter is not within a desired range of values, the control circuit modifies the treatment, or modifies at least one treatment parameter, or selects a different treatment protocol stored in the memory, the at least one treatment parameter to be modified including the dwell time of the dialysate to be infused, the treatment duration, and / or the composition.

[0084] Example 14. The apparatus according to Example 3, comprising at least one clinical sensor connected to the control circuit for measuring the chemical composition of the dialysate fluid within the tubing.

[0085] Example 15. The apparatus according to example 14, wherein the clinical sensor measures the ionic strength of the dialysate fluid and / or the dextrose level and / or urea level and / or creatinine level in the dialysate fluid.

[0086] Example 16. The apparatus according to any one of example 14 or example 15, wherein when the chemical composition is not within the desired value range, the control circuit signals the interface to generate a warning indication.

[0087] Example 17. The apparatus according to any one of example 14 to example 16, wherein when the chemical composition is not within the desired value range, the control circuit modifies the treatment, or modifies at least one treatment parameter, or selects a different treatment protocol, and the at least one modified parameter of the treatment includes the residence time of the dialysate to be infused, the treatment duration, and / or the composition.

[0088] Example 18. The apparatus according to example 1, further comprising at least one sensor for measuring the biological and / or chemical and / or physical properties of the dialysate discharged during the discharge process, and the control circuit detects peritonitis based on the measured properties of the discharged dialysate.

[0089] Example 19. The apparatus according to example 18, further comprising an interface for delivering instructions to the patient and / or caregiver, and when the peritonitis is detected, the control circuit signals the interface to generate a warning indication.

[0090] Example 20. The apparatus according to example 19, further comprising a communication circuit, and the communication circuit transmits the warning indication to a doctor.

[0091] Example 21. The apparatus according to any one of example 18 to example 20, wherein when the peritonitis is detected, the control circuit modifies at least one parameter of the treatment protocol or selects an alternative treatment protocol stored in the memory.

[0092] Example 22. The apparatus according to any one of Examples 18 to 21, wherein the physical property includes the turbidity level of the discharged dialysate.

[0093] Example 23. The apparatus according to any one of Examples 18 to 22, wherein the at least one sensor is an optical sensor configured to measure at least one optical parameter of the discharged dialysate at one or more wavelengths.

[0094] Example 24. The apparatus according to Example 23, wherein the at least one sensor is configured to measure absorption and / or scattering of light passing through the discharged dialysate at one or more wavelengths within the range of 500 to 650 nm and / or within the range of 150 to 350 nm.

[0095] Example 25. The apparatus according to Example 18, comprising a first sensor configured to measure absorption and / or scattering of light passing through the discharged dialysate at one or more wavelengths within the wavelength range of 500 to 650 nm, and a second sensor configured to measure absorption and / or scattering of light passing through the discharged dialysate at one or more wavelengths within the wavelength range of 150 to 350 nm.

[0096] Example 26. The apparatus according to Example 18, comprising a first sensor configured to measure absorption and / or scattering of light passing through the discharged dialysate within the wavelength range of 500 to 650 nm, and a second sensor configured to measure absorption and / or scattering of light passing through the discharged dialysate at visible light wavelengths.

[0097] Example 27. The apparatus according to any one of Examples 24 to 26, wherein the control circuit detects peritonitis based on the light absorption and / or light scattering measurement.

[0098] Example 28. The apparatus according to any one of the preceding examples, comprising a battery electrically connected to the control circuit.

[0099] Example 29. A peritoneal dialysis system, A durable unit comprising an electric motor and a battery electrically connected to the electric motor and configured to provide power to the electric motor, A removable unit configured to be attached to the durable unit, comprising a rotor connectable to the motor and tubing in at least partial contact with the rotor, A system comprising the above and having a system weight of less than 4000 gr.

[0100] Example 30. The system according to Example 29, wherein the system does not comprise a dialysate heater.

[0101] Example 31. A method for detecting a physiological state with the drained dialysate, comprising: Measuring at least one parameter related to the content of the drained dialysate by at least one sensor or manual indicator of a peritoneal dialysis device; Detecting a physiological state based on the at least one parameter. A method comprising the above.

[0102] Example 32. The method according to Example 31, wherein the physiological state includes peritonitis, pre-peritonitis, or post-peritonitis.

[0103] Example 33. The method according to Example 31, further comprising indicating a treatment related to the physiological state based on the detecting.

[0104] Example 34. The method according to Example 33, wherein the indicating includes indicating to a user of the device to add an antibiotic to a dialysate bag.

[0105] Example 35. The method according to any one of Example 33 or Example 34, wherein the indicating includes indicating to switch a dialysate bag to a bag containing an antibiotic.

[0106] Example 36. The method according to any one of Examples 32 to 35, wherein the at least one parameter is a parameter related to inflammation, and the physiological state includes inflammation.

[0107] Example 37. The method according to Example 36, wherein the parameter related to inflammation includes the turbidity level of the discharged dialysate.

[0108] Example 38. The method according to Example 36, wherein the parameter related to inflammation includes the level of white blood cells and / or bacteria in the discharged dialysate.

[0109] Example 39. The method according to any one of Examples 32 to 38, wherein the indicating includes injecting an antibiotic solution into the peritoneal cavity.

[0110] Example 40. The method according to any one of Examples 31 to 39, further comprising determining the peritoneal dialysis treatment effect based on the value of the at least one parameter measured.

[0111] Example 41. The method according to Example 40, wherein the at least one parameter includes the dextrose level of the discharged dialysate.

[0112] Example 42. The method according to either Example 40 or Example 41, wherein the at least one parameter includes the creatinine level of the discharged dialysate.

[0113] Example 43. The method according to any one of Examples 40 to 42, wherein the at least one parameter includes the urea level of the discharged dialysate.

[0114] Example 44. The method according to any one of Examples 40 to 43, wherein the indicating includes increasing the retention time of the dialysate in the peritoneal cavity when the effect is lower than the desired effect.

[0115] Example 45. The method according to any one of Examples 40 to 44, comprising indicating to the patient and / or caregiver when the effect is not the desired effect or when peritonitis is detected.

[0116] Example 46. The method according to any one of Examples 40 to 45, comprising transmitting an instruction to a physician when the effect is not the desired effect or when peritonitis is detected.

[0117] Example 47. A removable unit of a peritoneal dialysis device, a removable housing for receiving the removable unit, tubing having two openings shaped and dimensioned to be partially associated with a pump rotor within the housing, at least two connectors, wherein each of the two connectors is connected to the tubing at one of the two openings, and the two connectors are fixed to the same side of the housing.

[0118] Example 48. The unit according to Example 47, wherein at least one of the two connectors is a disinfection connector, and the tubing comprises a disinfection fluid proximal to the disinfection connector.

[0119] Example 49. The unit according to Example 48, wherein the disinfection connector comprises at least one foil shaped and dimensioned to be broken by an external connector.

[0120] Example 50. The unit according to any one of Examples 47 to 49, comprising at least two flow regulators surrounding the tubing near the connector, the flow regulators being shaped and dimensioned to allow fluid to flow between the tubing and the connector.

[0121] Unless otherwise defined, all technical and / or scientific terms used herein shall have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice and testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0122] As will be appreciated by one of ordinary skill in the art, some embodiments of the present invention may be embodied as a system, method, or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects that may all generally be referred to herein as a "circuit," "module," or "system." Further, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer-readable media having computer-readable program code embodied therein. The implementation of the methods and / or systems of some embodiments of the present invention can include performing and / or completing selected tasks manually, automatically, or a combination thereof. Further, according to the actual instrumentation and equipment of some embodiments of the methods and / or systems of the present invention, some selected tasks can also be implemented by hardware, software, firmware, and / or a combination thereof, for example, using an operating system.

[0123] For example, the hardware for performing selected tasks according to some embodiments of the present invention can also be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention can also be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are performed by a data processor such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is similarly provided. Optionally, a display and / or a user input device such as a keyboard or mouse are similarly provided.

[0124] Any combination of one or more computer-readable media can be used with some embodiments of the present invention. A computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of computer-readable storage media would include an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. A computer-readable storage medium, as relevant in the context of this specification, can be any tangible medium that can store or retain a program for use by or in connection with an instruction execution system, apparatus, or device.

[0125] A computer-readable signal medium may include a propagated data signal having computer-readable program code embodied therein, for example, at baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including but not limited to electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium that is not a computer-readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0126] The program code embodied on a computer-readable medium and / or the data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, fiber optic cable, RF, or any suitable combination of the foregoing.

[0127] The computer program code for performing operations regarding some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages such as Java (registered trademark), Smalltalk, C++, and conventional procedural programming languages such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, partly on the user's computer as a stand-alone software package, partly on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (e.g., through the Internet using an Internet service provider).

[0128] Some embodiments of the present invention may be described below with reference to the flowchart diagrams and / or block diagrams of methods, apparatuses (systems), and computer program products according to embodiments of the present invention. It will be understood that each block of the flowchart diagrams and / or block diagrams, and combinations of blocks in the flowchart diagrams and / or block diagrams, can be implemented by computer program instructions. These computer program instructions are provided to the processor of a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to produce a machine that, when executed by the processor of the computer or other programmable data processing apparatus, creates means for implementing the functions / operations specified in one or more blocks of the flowchart diagrams and / or block diagrams.

[0129] These computer program instructions can also be stored in a computer-readable medium that can direct a computer, other programmable data processing apparatus, or other device to function in a particular manner so as to produce a product that includes instructions stored in the computer-readable medium that implement the functions / operations specified in one or more blocks of the flowchart diagrams and / or block diagrams.

[0130] The computer program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other device so that a series of operational steps are performed on the computer, other programmable apparatus, or other device to produce a process implemented on the computer that provides a process for implementing the functions / operations specified in one or more blocks of the flowchart diagrams and / or block diagrams.

[0131] Some of the methods described herein are generally designed for use by a computer and may not be feasible or practicable to perform manually by a human expert. A human expert who wishes to perform a similar task manually, such as monitoring peritoneal dialysis treatment, is expected to use a completely different method, for example, by leveraging expertise and / or the pattern recognition ability of the human brain, which would be much more efficient than manually proceeding through the steps of the methods described herein.

[0132] Some embodiments of the present invention are described herein by way of example only with reference to the accompanying drawings. Referring specifically and in detail to the drawings, it is emphasized that what is specifically shown is merely an example for the purpose of illustratively explaining embodiments of the present invention. In this regard, the description taken together with the drawings will make it clear to those skilled in the art how embodiments of the present invention may be implemented.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0134] In some embodiments, the present invention relates to an apparatus for monitoring a treatment, and more specifically, but not exclusively, to an apparatus for monitoring peritoneal dialysis treatment.

[0135] In a broad aspect of some embodiments, it relates to adjusting various parameters of peritoneal dialysis treatment based on at least one effect of the treatment. Optionally, the correction of the treatment parameters is applied by a peritoneal dialysis device. In some embodiments, the adjustment includes modifying the duration of the infusion process and / or the duration of the drainage process and / or the dwell time of the dialysate in the peritoneal cavity. In some embodiments, the adjustment includes, for example, modifying the composition of the dialysate to be infused and / or selecting a different protocol plan to treat peritonitis. In some embodiments, the adjustment includes modifying at least one parameter of the treatment protocol according to an undesirable treatment effect. In some embodiments, the treatment is postponed or proposed. In some embodiments, the amount of dialysate per day is modified. In some embodiments, the treatment schedule and / or treatment type are modified.

[0136] One aspect of some embodiments relates to modifying peritoneal dialysis treatment during a treatment session. In some embodiments, the treatment is automatically modified based on feedback or input from the user during the treatment session. In some embodiments, the input includes changes in treatment duration and / or treatment start timing. Alternatively or in addition, the treatment is modified based on measurements taken during the treatment session. In some embodiments, the treatment is modified based on measurements taken between treatment sessions, for example, clinical measurements of the patient.

[0137] According to some exemplary embodiments, the treatment is modified if the treatment is not safe. In some embodiments, the treatment is modified if at least one parameter value results in a treatment that is not safe. In some embodiments, the treatment is modified or delayed when the contents of the dialysate bag and / or the identification information of the dialysate bag and / or the expiration date of the dialysate bag are not valid. Alternatively or in addition, the treatment is modified based on information received prior to the treatment session, for example, regarding the validity of the contents of the dialysate bag.

[0138] In some embodiments, the treatment is modified based on the measurement of parameters indicating inflammation, for example, body temperature measurement and / or turbidity level of the dialysate discharged. In some embodiments, the parameter indicating inflammation includes the level of white blood cells (WBC) in the discharged dialysate. In some embodiments, a white blood cell count higher than a determined level, for example, 40 WBC / ml, for example, 50, 55, 60, 65 WBC / ml, or any intermediate value or a value greater than that indicates inflammation. In some embodiments, the WBC count is relative to, for example, a baseline or reference count before the treatment. Alternatively, the WBC count is compared to known clinical criteria, for example, to detect clinical variations, or in some embodiments, the treatment is modified based on measurements providing an indication regarding the patient's general clinical condition, for example, heart pulse, blood pressure, and / or body temperature, and / or body weight, or change in body weight. In some embodiments, the treatment is modified based on measurements providing an indication regarding the treatment effect, for example, dextrose level, creatinine level, urea level, potassium level, phosphorus level, or any chemical, mineral, or biological substance in the discharged dialysate. In some embodiments, the amount of fluid in the discharged dialysate is also an indicator regarding the treatment effect. In some embodiments, after food intake, the expected amount of dialysate to be discharged is calculated, and optionally, the treatment effect is determined based on the relationship between the actual volume and the expected volume of the discharged dialysate.

[0139] In some embodiments, the measurement is relative to a baseline or reference measurement. In some embodiments, the measured value is compared to a known standard, for example, to determine clinical variability. In some embodiments, the level of dextrose, creatinine, urea, potassium, phosphorus, or any chemical, mineral, or biological substance in the dialysate being drained is related to a specific dwell time of the dialysate in the peritoneal cavity. In some embodiments, the memory of the device stores a range of values for chemical and / or biological parameters measured within a specific dwell time.

[0140] One aspect of some embodiments relates to compensating for variations in a planned peritoneal dialysis treatment during therapy. In some embodiments, the peritoneal dialysis device changes the peritoneal dialysis treatment protocol in accordance with a modification of the treatment introduced by the patient and / or caregiver or by the computer itself, for example, when the dialysate bag is not a valid bag. In some embodiments, the treatment is modified by the device, for example, when a treatment session is terminated prematurely, or when the catheter is disconnected or prematurely disconnected, or upon any action that does not conform to a pre-determined treatment protocol. Alternatively or in addition, the peritoneal dialysis treatment device changes the peritoneal dialysis treatment protocol according to the measurement of at least one clinical parameter.

[0141] One aspect of some embodiments relates to monitoring a peritoneal dialysis treatment during therapy. In some embodiments, the device delivers instructions and / or warnings to the patient based on the monitoring of the treatment. In some embodiments, the peritoneal dialysis device monitors different steps of the treatment, such as the creation and / or disinfection of the fluid path to the patient catheter, and the pumping and / or draining of the dialysate. In some embodiments, the device measures the patient's clinical parameters, such as pulse, blood pressure, and / or body temperature. In some embodiments, the device determines whether the actual treatment conforms to a pre-determined treatment plan.

[0142] One aspect of some embodiments relates to the detection and / or treatment of peritonitis, and / or monitoring the progression of peritonitis. In some embodiments, peritonitis is detected and / or treated during a peritoneal dialysis treatment session. In some embodiments, peritonitis is detected by analyzing the dialysate drained during the treatment session. Optionally, the contents of the drained dialysate are continuously analyzed during the treatment session. Alternatively, the contents of the drained dialysate are analyzed at least twice during the drainage procedure of the dialysis treatment. In some embodiments, for example, the levels of white blood cells and / or pro-inflammatory cytokines and / or levels of live or dead bacteria and / or fungal levels in the drained dialysate are measured to enable the detection of peritonitis. In some embodiments, after the detection of peritonitis, the patient receives an instruction to inject an antibiotic into a fresh dialysate bag at a specific number of exchange cycles.

[0143] In some embodiments, peritonitis is detected based on the measurement of the patient's clinical parameters. In some embodiments, the clinical parameters are measured during the treatment session. Optionally, peritonitis is detected based on a combination of the measurement of the clinical parameters and the analysis of the contents of the drained dialysate. In some embodiments, an instruction is provided when peritonitis is detected based on the measured clinical parameters and / or the analysis of the drained dialysate. In some embodiments, the instruction is delivered to the patient and / or the physician and / or the caregiver.

[0144] In some embodiments, the measured values of the clinical parameters and / or the analysis results of the drained dialysate are delivered to a decision maker, such as a physician or a device or a remote computer, for detecting peritonitis. In some embodiments, the measured values of the clinical parameters and / or the analysis results of the drained dialysate are delivered to a decision maker for monitoring the progression of peritonitis.

[0145] In some embodiments, peritonitis or a peritonitis indication is determined based on the turbidity level or change in turbidity of the drained dialysate. In some embodiments, the turbidity level of the drained dialysate is an indicator of the level of inflammation. In some embodiments, the turbidity level of the drained dialysate is an indicator of the level of bacteria and / or fungi in the peritoneal space. In some embodiments, when the measured turbidity level exceeds a desired turbidity threshold, an indication is provided to the patient and / or the physician and / or the caregiver.

[0146] In some embodiments, when peritonitis is detected, peritoneal dialysis treatment is terminated or modified. In some embodiments, when peritonitis is detected, a peritonitis treatment plan is proposed. In some embodiments, the peritonitis treatment plan includes at least one wash of the peritoneal cavity with an antibiotic or anti-inflammatory solution. Alternatively or in addition, the peritonitis treatment plan includes the infusion of a dialysate solution containing an antibiotic and / or an anti-inflammatory agent.

[0147] According to some embodiments, to reduce the risk of peritonitis, the peritoneal dialysis device connects and disinfects the flow path to and / or from the patient's catheter. In some embodiments, to detect peritonitis, optionally early detection, the device measures and detects particles in the drained dialysate solution. In some embodiments, for example, a white or monochromatic light source is placed near the fluid flow path through which the drained dialysate flows. Optionally, a sensor, for example, an optical sensor, measures one or more optical parameters, such as the light absorption, light scattering of light moving through the drained dialysate at one or more wavelengths. Optionally, the optical sensor measures the decrease in the intensity of light while the light moves through the drained dialysate. In some embodiments, the device measures the absorption and / or scattering of light moving through the drained dialysate. In some embodiments, the spectrophotometer of the device identifies the presence of particles in the drained dialysate.

[0148] According to some embodiments, peritonitis is detected by measuring a shunt portion of the drained dialysate. In some embodiments, the drained dialysate is shunted to a test path, such as a test tube. In some embodiments, within the test tube, the drained dialysate reacts with a reagent housed in the device to produce a chemical reaction that, for example, generates a human-detectable indication regarding the presence of bacteria or WBC or particles in the drained dialysate. In some embodiments, the human-detectable indication is a color indication that is optionally detected by measuring the absorbance at a specific wavelength or within a wavelength range. In some embodiments, a color change is detected by a colorimeter of the device. Optionally, the tube is removable or is part of a removable unit of a PPDD device, also referred to herein as a disposable unit. In some embodiments, the tube comprises a test strip or reagent. In some embodiments, the peritoneal dialysis device comprises a mechanism to prevent backflow, for example, when the test tube is reused.

[0149] One aspect of some embodiments relates to optimizing peritoneal dialysis treatment during treatment. In some embodiments, the treatment is optimized during treatment based on an analysis of the drained dialysate. In some embodiments, the drained dialysate is an indicator of the functional level of the peritoneum. In some embodiments, when the function of the peritoneum falls below a desired threshold, at least one parameter of the dialysis treatment and / or the content of the dialysate solution is modified.

[0150] In some embodiments, the levels of chemical and / or biological compounds in the drained dialysate, such as dextrose, creatinine, and / or urea, are measured. In some embodiments, the dextrose level in the drained dialysate is compared to the dextrose level in fresh dialysate. In some embodiments, when the functional level of the peritoneum is lower than a threshold level, the dwell time of the dialysate in the peritoneal cavity is increased. In some embodiments, when the functional level of the peritoneum is higher than a threshold level, the dwell time is decreased.

[0151] In some embodiments, the level of dextrose in the drained dialysate is an indicator of the level of peritoneal degradation. In some embodiments, a high level of dextrose in the drained dialysate indicates that the peritoneum is undergoing apoptosis or sclerosis. In some embodiments, the peritoneum deteriorates due to, optionally, collagen denaturation (blockade) caused by membrane infection and / or inflammatory processes.

[0152] According to some embodiments, the level of creatinine in the drained dialysate is measured. In some embodiments, the creatinine level provides an indication regarding the effectiveness of peritoneal dialysis treatment. In some embodiments, a lower creatinine level, e.g., a creatinine level within the range of 0 - 7 mg / dcl, indicates that the treatment has a low effectiveness.

[0153] In some embodiments, the creatinine level is measured by diverting the flow of the drained dialysate to a specific region of the device outside the flow path of the drained dialysate. In some embodiments, in this region, the drained dialysate fluid reacts with at least one reagent housed in the device. In some embodiments, the reaction produces a color, and the intensity of the produced color is proportional to the amount of creatinine in the drained dialysate. In some embodiments, a white or single - color light source and at least one light sensor array of the device are disposed near the flow path of the drained dialysate. In some embodiments, the light sensor senses the intensity of the light traveling through the drained dialysate from the light source. In some embodiments, the device measures the decrease in the intensity of the light.

[0154] In some embodiments, for example, the measurement of the color reaction, which is the Jaffe reaction of a calorimetric technique where creatinine forms an orange complex with picric acid in an alkaline solution, indicates the amount of creatinine removed during the last dialysis session. This colored complex is determined by spectrophotometry. In some embodiments, the intensity of the produced color is directly proportional to the amount of creatinine in the sample. Alternatively, an enzyme housed in the device produces a colorimetric reaction that is an indicator of the creatinine level.

[0155] According to some embodiments, the level of urea in the drained dialysate is measured. In some embodiments, the urea level provides an indication regarding the effectiveness of the peritoneal dialysis treatment. In some embodiments, a lower urea level, e.g., a urea level within the range of 0 to 15 mg / dcl, indicates that the treatment has a low effectiveness.

[0156] In some embodiments, the urea level is measured by diverting the flow of the drained dialysate to a specific region of the device outside the flow path of the drained dialysate. In some embodiments, in this region, the drained dialysate fluid reacts with at least one reagent housed in the device. In some embodiments, the reaction produces a color, and the intensity of the produced color is proportional to the amount of creatinine in the drained dialysate.

[0157] In some embodiments, the diacetyl monoxime colorimetric method and the Berthelot reaction are used to measure the urea level. In some embodiments, in this method, urea is converted to ammonia by an enzyme called urease. The resulting ammonia is combined with 2-oxoglutarate and NADH in the presence of glutamate dehydrogenase (GDH) to produce L-glutamine and NAD. The decrease in NADH absorbance is proportional to the urea concentration.

[0158] According to some embodiments, the level of dextrose in the drained dialysate is measured. In some embodiments, the dextrose level provides an indication regarding the effectiveness of the peritoneal dialysis treatment. In some embodiments, a high dextrose level, e.g., a dextrose level exceeding 30% of the original concentration in a “fresh” dialysate solution, indicates that the treatment has a low effectiveness.

[0159] In some embodiments, the dextrose level is measured by diverting the flow of the drained dialysate to a specific region of the device outside the flow path of the drained dialysate. In some embodiments, in this region, the drained dialysate fluid reacts with at least one reagent housed in the device. In some embodiments, the reaction produces a color, and the intensity of the resulting color is proportional to the amount of dextrose in the drained dialysate.

[0160] In some embodiments, a white or single-color light source and at least one light sensor array of the device are disposed near the flow path of the drained dialysate. In some embodiments, the light sensor senses the intensity of the light traveling through the drained dialysate from the light source. In some embodiments, the device measures the decrease in the intensity of the light. In some embodiments, the measurement of the color reaction indicates the amount of dextrose in the drained dialysate. In some embodiments, the level of dextrose in the drained dialysate is compared to the dextrose level in the fresh dialysate, for example, to determine the treatment effect and / or the absorption of dextrose by the peritoneum.

[0161] One aspect of some embodiments relates to automatically determining patient compliance with peritoneal dialysis treatment. In some embodiments, the patient is treated at home. In some embodiments, patient compliance with the treatment is measured during the treatment session. In some embodiments, a compliance report is generated after each treatment session and optionally stored in memory. In some embodiments, a compliance instruction is delivered to the patient upon request or within a specific time period. In some embodiments, the compliance instruction is delivered to a physician or caregiver. Optionally, the compliance report is transmitted to the physician's remote computer.

[0162] According to some embodiments, the peritoneal dialysis device provides an exchange reminder, reduces patient errors, and increases patient compliance with the treatment by automatically disinfecting the flow paths to and from the patient catheter. In some embodiments, the exchange reminder includes a reminder regarding the infusion process and / or the drainage process. In some embodiments, the exchange procedure is performed within a predetermined time during the day. In some embodiments, the reminder is provided by a timer of the device. In some embodiments, for example, a predetermined exchange schedule is input into the device by medical staff or the patient. In some embodiments, based on this schedule, the device warns the patient of a scheduled exchange, and / or a delayed exchange (if predefined) and / or a missed exchange. In some embodiments, the device warns the medical staff by communication regarding a delayed and / or missed exchange. Optionally, the warning sent to the medical staff includes the patient ID and the missed exchange information, (e.g.) John Smith, ID, date, number of exchanges per day - delayed and time. Optionally, additional information is displayed upon request from the medical staff or other requirements. In some embodiments, if an exchange cycle is missed, for example, an alternative treatment plan is selected or at least one treatment parameter is modified to compensate for non-compliance.

[0163] According to some embodiments, the peritoneal dialysis device increases patient compliance and safety with the treatment by reducing patient errors. In some embodiments, the device guides the patient through the correct procedure. In some embodiments, the patient interacts with the device, for example, to confirm compliance with the process at each step. In some embodiments, the device activates automatic cycle control. In some embodiments, the device activates a treatment protocol that includes, for example, the type of dialysis solution the patient is instructed to use. In some embodiments, when a different type of solution is used, for example, a solution with an incorrect dextrose level, the device delivers a warning and / or ends the process or prevents the start of the process. In some embodiments, the dextrose level is measured by using a spectrophotometer, or by using a reagent housed in a device that interacts with the solution to change the light absorption at at least one wavelength, or by reading a label on the bag, such as a barcode.

[0164] According to some embodiments, the peritoneal dialysis device automatically connects and disinfects the flow path. Additionally, the device uses a controller and pumps to automatically perform the drainage process, the flushing process, and the dialysis solution filling process. In some embodiments, the device monitors the progress of the exchange process. In some embodiments, a predetermined exchange volume is input into the device memory by the medical staff. In some embodiments, the device calculates the volume of drained dialysis solution and / or the volume of infused dialysis solution and / or the remaining time until the completion of the process based on the measured flow rate. In some embodiments, the device delivers an indication to the patient or caregiver regarding the time and / or volume expected to complete the process and optionally displays the status, such as the percentage of process completion and / or the remaining time.

[0165] According to some embodiments, the device measures the flow of the dialysate using a sensor arranged outside the flow path, for example, using the ultrasonic transit time principle. In some embodiments, the principle is that an ultrasonic pulse moving in the fluid flow direction is accelerated, while an ultrasonic pulse moving in the direction opposite to the flow direction is decelerated. In some embodiments, at least four piezoelectric elements are arranged in an x-pattern near the flow path. In some embodiments, at least one transmitter transmits pulsed ultrasonic waves of a predetermined frequency from one side to the other side through the dialysate fluid flowing through the dialysate flow path. In some embodiments, the difference in transit time is proportional to the average fluid velocity. In some embodiments, using this technique, a sensor accuracy of + / -2% or higher, for example, + / -1% is achieved. Alternatively, the fluid flow is measured by counting the rotations of the pump during fluid injection and optionally subtracting the gas volume.

[0166] According to some exemplary embodiments, the device measures the temperature of the dialysate solution to be injected before the solution is injected into the patient's catheter. In some embodiments, if the measured temperature is not within the desired temperature range, for example, 37 + / - 2 °C, an indication is sent and / or the treatment is terminated. In some embodiments, the temperature sensor is arranged outside the fluid flow path, for example, by an IR sensor. Alternatively, the sensor is in contact with the outer wall of the fluid flow path tubing. In some embodiments, the device communicates with a heating device and / or an external temperature sensor to enable, for example, closed-loop control of the temperature of the dialysate solution.

[0167] According to some embodiments, the device comprises a scale for measuring the amount of dialysate discharged. In some embodiments, the device comprises a tilt mechanism to, for example, enable the release of air bubbles from the fluid flow path. In some embodiments, the device comprises a thermal insulation container to, for example, keep the dialysate bag warm during movement.

[0168] One aspect of some embodiments relates to automatically switching between different fluids. In some embodiments, different fluid bags are connected to a patient catheter through a fluid switching device. In some embodiments, the fluid switching device switches between different fluid bags without the need to connect or disconnect the bags from the patient catheter. In some embodiments, the fluid switching device switches between different fluids according to a treatment plan or after modification of an existing treatment plan. In some embodiments, a peritoneal dialysis device activates at least one fluid bag, for example, for later use.

[0169] In some embodiments, upon detection of peritonitis, the dialysate fluid is switched to an antibiotic or anti-inflammatory solution. Alternatively, the dialysate bag is switched to a dialysate bag containing dialysate and an antibiotic solution. In some embodiments, the fluid switching device is switched between dialysate fluids of various dextrose concentrations after analysis of peritoneal function. In some embodiments, the fluid switching device is switched between the dialysate fluid and a storage bag for the drained dialysate during a treatment session. In some embodiments, when peritonitis is detected and optionally the dialysate bag is switched, at least one protocol parameter is modified based on the medical condition and the treatment applied. In some embodiments, the protocol parameters that are modified include the duration of treatment or dwell time and / or the number of exchanges per day.

[0170] One aspect of some embodiments relates to a removable unit of a peritoneal dialysis device or system having at least two connectors on the same side, also referred to herein in some embodiments as a disposable unit. In some embodiments, the at least two connectors include a catheter connector and a dialysate bag connector. Optionally, the dialysate bag connector is a Y-connector. In some embodiments, the two connectors are disinfection connectors having a disinfection fluid near each of the connectors. In some embodiments, each of the connectors comprises a foil shaped and sized to allow penetration of an external connector and / or release of a disinfection fluid. In some embodiments, each of the connectors comprises a flow regulator, such as a removable clip, to control the flow between the disinfection connector and the external connector.

[0171] Possible advantages of using a device for monitoring and / or modifying peritoneal dialysis treatment include early detection of peritonitis, better compliance, and flexibility based on experience and knowledge in monitoring fluid extraction and dietary information related to fluid uptake into the peritoneal cavity and further fluids expected based thereon. Further advantages include optimizing treatment based on actual measurements (in-line), optionally based on urea, creatinine, and dextrose levels in the drained solution, and protecting (enhancing) peritoneal function over a longer period of time. The device enables detecting and optionally treating processes that reduce the treatment effect, for example, by early detection of inflammation of peritonitis and / or early detection of peritoneal dysfunction.

[0172] As described above, a possible advantage of the device is to enable early detection and optional treatment of peritonitis. The goals of peritonitis treatment include rapid resolution of inflammation by eradicating the causative bacteria and protection of peritoneal function. A single episode of peritonitis did not have a significant impact on long-term peritoneal function, but recurrence or clustering of infections has been demonstrated to cause an increase in the dialysate / plasma ratio of creatinine and a decrease in ultrafiltration, with the severity increasing with the number of episodes, so early detection and rapid resolution are important. Additionally, it has been demonstrated that solute transport increases over time with PD and ultrafiltration decreases. This process is worsened and accelerated by peritonitis and appears to be proportional to the degree of associated inflammation and the number of recent infections.

[0173] Persistent and severe PD peritonitis with a catheter remaining can lead to peritoneal dysfunction and is the most common factor for technical withdrawal from PD (transfer to HD). Using the peritoneal dialysis device described herein, peritonitis caused by PD can be detected and optionally treated during treatment, although it is not empirically treated while waiting for the results of the dialysate culture. Antibiotics are preferentially delivered via the peritoneal route where the maximum concentration is reliably delivered to the site of infection. However, it should be noted that drugs administered intraperitoneally may be absorbed into the systemic circulation.

[0174] As described above, a possible advantage of the device is an increase in treatment efficiency (effect). Treatment efficiency is related to (1) the patient's health status, among other indications, particularly vital signs, namely, pulse, BP, and weight, (2) waste products extracted from the blood, namely, urea, creatinine, and (3) removal of excess water from the blood.

[0175] According to some embodiments, a patient is connected to a dialysis system, such as a portable peritoneal dialysis system (PPDS), during one or more treatment cycles. In some embodiments, a treatment cycle includes the infusion of fresh dialysate, the dwell of the dialysate within the patient's peritoneal cavity, and the drainage of the dialysate, or the drainage of the dialysate, the infusion of fresh dialysate, and the dwell of the dialysate within the peritoneal cavity. Alternatively, the PPDS is disconnected from the patient during the dwell time. In some embodiments, when the PPDS is connected to the patient, a portion of the dialysate is drained, for example, to monitor the patient's physiological state and / or treatment efficacy. In some embodiments, a partial replacement of the dialysate is performed during the dwell time, for example, 10%, 20%, 30%, 50%, 60%, 70%, or any intermediate percentage, a smaller percentage, or a larger percentage of the dialysate within the peritoneum is drained and optionally replaced with fresh dialysate.

[0176] According to some embodiments, the dialysis system is portable and configured to be secured to a body part of the patient by a belt, harness, or any adapter. In some embodiments, the dialysis system comprises a durable unit that includes a motor, such as an electric motor, and a battery, optionally a rechargeable battery electrically connected to the rotor. In some embodiments, the durable unit comprises a control circuit electrically connected to the motor and to the battery. In some embodiments, the control unit controls the operation of the motor according to the power level of the battery. In some embodiments, the durable unit comprises an interface connected to the control circuit configured to provide at least one human-detectable indication, such as a warning signal by a light indication and / or a sound indication. In some embodiments, when the power level of the battery is lower than a predetermined value, the control circuit signals the interface to generate a warning signal, such as a signal indicating to charge the battery or replace the battery. Alternatively or in addition, when the power level of the battery is lower than a predetermined value, the control circuit stops the operation of the motor.

[0177] According to some embodiments, the control circuit operates the motor in a power-saving mode, for example, when the power level of the battery is lower than a predetermined value. In some embodiments, when the control circuit optionally operates the motor in a power-saving mode, it modifies at least one operating parameter of the motor, such as the rotational speed and / or the rotation duration. In some embodiments, the control circuit prevents the operation of the motor when the power level of the battery is lower than a predetermined value.

[0178] According to some embodiments, the power level of the battery when fully charged is sufficient for at least one dialysis treatment session, such as two treatment sessions, three treatment sessions, four treatment sessions, or any smaller number, intermediate number, or larger number of treatment sessions. In some embodiments, a treatment session includes at least partially draining dialysis fluid from the peritoneal cavity and at least partially injecting fresh dialysis fluid into the peritoneal cavity. Alternatively, a treatment session includes at least partially draining dialysis fluid from the peritoneal cavity, at least partially injecting fresh dialysis fluid into the peritoneal cavity, and the dwell time of the dialysis fluid in the peritoneal cavity.

[0179] Optionally, the dialysis system does not include a heater, such as a dialysis fluid heater. In some embodiments, the dialysis system does not include a heater, for example, to conserve battery power and / or to reduce the total weight of the dialysis system.

[0180] According to some embodiments, the weight of the dialysis system is in the range of 500 gr to 5 kg (5000 gr), for example, 1 kg, 1.5 kg, 2 kg, 2.5 kg, or any intermediate weight, a smaller weight, or a larger weight. Optionally, the weight of the dialysis system is less than 4000 gr. In some embodiments, the length of the device is in the range of 100 mm to 450 mm, for example, 100 mm, 150 mm, 170 mm, 200 mm, or any intermediate value, a smaller value, or a larger value. In some embodiments, the width of the device is in the range of 80 mm to 300 mm, for example, 100 mm, 130 mm, 150 mm, or any intermediate value, a smaller value, or a larger value.

[0181] According to some embodiments, the dialysis system comprises at least one connecting member, such as a harness, belt, or adapter, configured to secure the system to at least one body part of the patient, such as the waist, leg, shoulder, or thigh.

[0182] Before explaining in detail at least one embodiment of the present invention, it is understood that the present invention is not necessarily limited to the configurations and arrangements of the components described in the following description and / or shown in the drawings and / or examples and / or to the details of their application to the methods. The present invention is capable of other embodiments or of being practiced or carried out in various ways.

[0183] Exemplary device Reference is now made to FIG. 1, which illustrates a system or device for peritoneal dialysis treatment according to some embodiments of the present invention.

[0184] According to some exemplary embodiments, system 100 comprises device 102, a dialysis fluid bag 124 or a drainage bag, and a patient catheter connected to patient 130. In some embodiments, device 102 is connectable to dialysis fluid bag 124 and / or to the drainage bag so as to optionally form a sterilized flow path between the bag and patient 130.

[0185] According to some exemplary embodiments, the apparatus 102 comprises a controller 104 and a fluid treatment module 112 optionally including a pump. In some embodiments, the controller 104 controls the operation of the fluid treatment module, for example, when the fluid treatment module is activated to inject dialysate into the peritoneal cavity or when the fluid treatment module is activated to drain the peritoneal cavity. In some embodiments, the controller 104 controls the connection of the dialysate bag 124 and / or the drain bag to the apparatus 102. Additionally, the controller 104 controls the connection of the patient catheter to the apparatus 102.

[0186] According to some exemplary embodiments, the controller 104 monitors and controls the automatic connection and disinfection of different components connected to the flow path. In some embodiments, it delivers an indication, for example, an indication detectable by a human, when a component is connected to the flow path and / or when the flow path is disinfected. Alternatively or in addition, the controller stores the indication in a memory.

[0187] According to some exemplary embodiments, the controller 104 monitors the flow within the flow path by different sensors of the apparatus 102, such as the hydrodynamic sensor 116. In some embodiments, the hydrodynamic sensor comprises at least one volume sensor for monitoring, for example, the volume of the fluid padding passing through the flow path. Additionally, the hydrodynamic sensor includes at least one temperature control sensor for monitoring and controlling, for example, the temperature of the fluid passing through the flow path.

[0188] According to some exemplary embodiments, the apparatus 102 includes at least one clinical sensor 114 for sensing changes in clinical parameters, for example. In some embodiments, the at least one clinical sensor senses the chemical and / or biological content of the dialysate drained, for example, using a creatinine sensor and / or a urea sensor. In some embodiments, the at least one clinical sensor 114 includes, for example, a dextrose sensor 132 for sensing the dextrose level in the dialysate drained. Optionally, the dextrose sensor 132 senses the dextrose level in the dialysate infused. In some embodiments, the clinical state of the subject is based on a comparison of the dextrose level in the dialysate drained and the dextrose level in the dialysate infused, in addition to the measurement time and / or the subject's body mass.

[0189] According to some exemplary embodiments, the apparatus 102 includes at least one sensor for detecting urea level, for example, a urea sensor 134. In some embodiments, the clinical state of the patient is determined based on the measured urea level, in combination with the measurement time and / or the subject's body mass.

[0190] According to some exemplary embodiments, the apparatus 102 comprises at least one glucose sensor 132 configured to measure the glucose level in the dialysate. In some embodiments, in addition to the measurement time and / or the patient's body mass, the clinical state of the patient is determined based on a comparison between the level of glucose in the drained dialysate and the glucose level in the fresh dialysate. Alternatively, the glucose level in the drained dialysate, optionally compared to the dialysate being infused or a stored value, indicates the dialysis effect and / or the state of the peritoneum. In some embodiments, the apparatus 102 comprises at least one sensor for detecting the creatinine level in the dialysate. In some embodiments, the level of creatinine in the drained dialysate, optionally compared to the creatinine level in the fresh dialysate, indicates the clinical state of the subject. Alternatively, the creatinine level indicates the dialysis effect and / or the state of the peritoneum. In some embodiments, the clinical sensor 114 is actuated during a treatment session, for example, during the infusion and / or drainage of the dialysate.

[0191] According to some exemplary embodiments, the controller delivers instructions and / or warnings to a patient in the vicinity of the apparatus 102 or to a caregiver. Alternatively or in addition, the controller transmits instructions and warnings to a remote computer, such as a physician's computer. In some embodiments, the physician transmits information to the apparatus 102, for example, to modify at least one treatment parameter or to select a different treatment plan.

[0192] According to some exemplary embodiments, the device 102 delivers time reminders and / or instructions to the patient to perform treatment steps. In some embodiments, a user of the device, such as a patient or caregiver, optionally provides user input through a user interface comprising at least one button, such as an activation button or a treatment end button. In some embodiments, the input received from the user and additional user data are stored in the device 102. In some embodiments, the stored user data is transmitted to a physician, for example, to enable remote monitoring of the user's condition throughout the treatment process. Additionally, an operation log file of the device 102 is also stored and optionally used to generate a patient compliance report after a treatment session.

[0193] According to some exemplary embodiments, the device 102 further comprises a battery 106, such as a rechargeable battery, to enable the operation of an electric pump optionally connected to the controller 104 and / or the fluid processing module 112. Alternatively, the battery is electrically connected to an electric motor optionally connected to the fluid processing module 112. In some embodiments, the device 102 comprises a charging socket or plug electrically connected to the battery to enable charging of the battery by an external power source, for example. Alternatively, the battery is a replaceable battery.

[0194] According to some exemplary embodiments, the device 102 is connected to a computer server, such as server 105. In some embodiments, the server 105 stores treatment protocols and / or device operation log files. In some embodiments, the controller 104 writes measurements of parameters related to the operation of the device and / or parameters related to the clinical condition of the patient to the server 105. Optionally, a physician communicates with the server 105, for example, to receive the device's log file and / or to deliver treatment orders or modifications. In some embodiments, the server 105 transmits information to a caregiver, such as a nurse or a warehouse, for example, to supply a new dialysis fluid bag.

[0195] According to some exemplary embodiments, the device 102 communicates with the caregiver 103, for example, to provide the caregiver with clinical information of the patient and / or other information related to the treatment. In some embodiments, the device 102 communicates with the physician 109. In some embodiments, the device 102 delivers a warning to the physician 109 if the actual treatment is different from the pre-determined treatment. Alternatively or in addition, the device 102 delivers a warning to the physician 109 if the desired result of the treatment has not been achieved. In some embodiments, the physician 109 communicates with the patient through the device 102, for example, to deliver instructions and / or to receive more information from the patient.

[0196] According to some exemplary embodiments, the device 102 is connected to or comprises a bag switcher 107. In some embodiments, the device 102, optionally a removable and / or portable device, is attached to the bag switcher 107 during a peritoneal dialysis treatment, for example, during an exchange process. In some embodiments, at least one dialysis fluid bag, for example, bag 124, is connected to the bag switcher 107. In some embodiments, the bag switcher 107 verifies that the correct bag is connected, optionally using a bar code or different ID of the bag. In some embodiments, the bag switcher 107 monitors the temperature of the bag and optionally heats the bag using a heating mechanism. In some embodiments, when the exchange session ends, the removable device is disconnected from the bag switcher 107.

[0197] According to some exemplary embodiments, the apparatus comprises a warmer, e.g., warmer 111. Alternatively, the warmer is part of system 100 and / or part of bag switcher 107. In some embodiments, the warmer is used to monitor and / or control the temperature of the dialysis fluid bag. In some embodiments, controller 104 receives a signal from warmer 111 or from a temperature sensor regarding the temperature of the dialysis fluid. In some embodiments, controller 104 issues a signal to warmer 111 to heat the dialysis fluid, e.g., by heating the dialysis fluid bag. Alternatively, controller 104 issues a signal to bag switcher 107 to switch the dialysis fluid bag to a bag at a desired dialysis fluid temperature.

[0198] According to some exemplary embodiments, apparatus 102 communicates with a hand-held device 123, e.g., a cellular phone. In some embodiments, apparatus 102 transmits warnings and / or instructions and / or information to hand-held device 123. Optionally, apparatus 102 communicates with hand-held device 123 using an application program installed on the device. In some embodiments, apparatus 102 delivers a time warning or any time warning to hand-held device 123 prior to the start of treatment. In some embodiments, the hand-held device optionally uses an application program to at least partially control the operation of apparatus 102. In some embodiments, apparatus 102 receives information from a hand-held device 123, e.g., a smart watch or any other device connected to a wearable sensor.

[0199] Reference is now made to FIG. 2, showing components of an apparatus for monitoring and modifying peritoneal dialysis treatment, according to some embodiments of the present invention.

[0200] According to some exemplary embodiments, the apparatus 202 includes a controller 204 that optionally functions as the controller 104. In some embodiments, the controller 204 is connected to a fluid control unit 208 that monitors and / or controls the flow of fluid through the apparatus 202. In some embodiments, the fluid control unit 208 monitors the connection of different bags, such as a dialysate bag or a drainage bag, to the flow path leading to the patient catheter. Optionally, the fluid control unit 208 monitors the connection of the patient catheter to the flow path. In some embodiments, the fluid control unit monitors and / or controls the disinfection of the flow path between the patient catheter.

[0201] According to some exemplary embodiments, the apparatus 202 includes at least one sensor 206 connected to the controller 204 and / or the fluid control unit 208. In some embodiments, the sensor 206 monitors flow parameters of the fluid in the flow path, such as the temperature, pressure, and / or volume of fluid passing through the flow path over a selected period of time. Alternatively, the sensor 206 senses the contents of the dialysate discharged during the drainage process. In some embodiments, the sensor 206 senses the chemical and / or mineral and / or biological contents of the discharged dialysate, such as creatinine levels, dextrose levels, and / or urea levels.

[0202] According to some exemplary embodiments, the sensor 206 senses at least one parameter related to the inflammatory process. In some embodiments, the sensor 206 senses the turbidity level of the discharged dialysate. In some embodiments, the turbidity level is an indicator of the bacterial level and the inflammation level in the discharged dialysate and the peritoneal cavity. Alternatively or additionally, the sensor 206 senses at least one biological parameter, such as the level of white blood cells, such as neutrophils, and / or the level of pro-inflammatory cytokines.

[0203] According to some exemplary embodiments, at least one sensor, e.g., sensor 206, comprises an optical sensor for measuring one or more optical parameters, e.g., light absorption and / or light scattering of light passing through fresh dialysate and / or drained dialysate. In some embodiments, the at least one optical sensor is configured to measure light absorption and / or light scattering at one or more wavelengths within a range of 500 - 650 nm, e.g., within a range of 500 - 600 nm, within a range of 550 - 620 nm, within a range of 530 - 630 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range. Additionally or alternatively, the at least one additional sensor is configured to measure absorption and / or scattering of light passing through fresh dialysate and / or drained dialysate at one or more wavelengths within a wavelength range of 150 - 350 nm, e.g., within a range of 150 - 250 nm, 200 - 300 nm, 250 - 350 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range. In some embodiments, the at least one sensor includes a sensor for measuring absorption and / or scattering within the visible light spectrum. In some embodiments, a combination of at least two sensors is used, e.g., to determine the level of white blood cells and / or to detect peritonitis. In some embodiments, at least one sensor configured to measure light absorption and / or light scattering is used to detect air bubbles in the dialysate fluid and / or to determine the quality and / or flow rate of the fluid.

[0204] According to some exemplary embodiments, the controller is connected to at least one external sensor 218 via a wired or wireless connection. In some embodiments, the external sensor 218 measures at least one clinical parameter of the patient, e.g., blood pressure, body temperature, heart rate, or other clinical parameters of the patient. In some embodiments, the external sensor 218 is a wearable sensor, e.g., a sensor connected to the patient's wrist. In some embodiments, the sensor 206 is configured to measure the same clinical parameters of the patient as the external sensor 218.

[0205] According to some exemplary embodiments, the controller 204 is connected to the interface 214, for example, to receive input from a patient or caregiver. In some embodiments, the interface 214 includes at least one button, such as an activation button or a treatment end button. In some embodiments, the device 202 uses the interface 214 to deliver instructions and warnings to a patient and / or caregiver present in the vicinity of the device. In some embodiments, the interface 214 delivers a human-detectable instruction, such as a light instruction. In some embodiments, the interface includes a display 216, for example, to visually deliver information to a patient. In some embodiments, the instructions and / or data delivered by the interface 214 include treatment-related reminders, treatment-related commands, and warnings, such as safety warnings.

[0206] According to some exemplary embodiments, the device 202 includes a communication module 210, for example, to transmit and receive information with a remote device. In some embodiments, the communication module 210 includes a wireless receiver and a wireless transmitter. In some embodiments, the communication module 210 wirelessly transmits instructions, warnings, and treatment-related information to a remote computer or a remote handheld device. In some embodiments, the communication module receives wireless transmissions from different devices, such as a remote computer, optionally at least one sensor attached to a patient, or a remote handheld device. In some embodiments, the communication module 210 is configured to transmit and receive Wi-Fi signals, infrared signals, and / or Bluetooth® signals.

[0207] According to some exemplary embodiments, the device 202 comprises a power source 220, e.g., a power supply unit. In some embodiments, the power source 220 comprises at least one rechargeable battery, e.g., a lithium-ion battery that is optionally removable from the device 202. In some embodiments, the device 202 is connected to a base unit or disposed within a cradle between treatment sessions, e.g., to charge the battery and / or to download or upload information from the memory storage inside the base unit. In some embodiments, the device 202 comprises a charging socket or charging plug, e.g., to enable charging of the battery by an external power source.

[0208] According to some exemplary embodiments, the device 202 comprises a memory 212 for storing a treatment plan, information related to the patient, a log file of the device, or any other information related to the patient, treatment, and / or the device. In some embodiments, the controller 204 writes information to or reads information from the memory 212 during and / or between treatment sessions.

[0209] Exemplary process for modifying treatment during a treatment session According to some exemplary embodiments, peritoneal dialysis treatment is modified during a treatment session, for example, during the infusion of dialysate into the peritoneal cavity or during the drainage of dialysate. In some embodiments, the treatment is modified according to measurements during the treatment session and / or inputs received during the treatment session. A possible advantage of modifying the treatment during the treatment session is that, for example, the pre-determined treatment can be adjusted to the patient's clinical condition during the treatment session itself in order to enable a more individualized treatment. Here, reference is made to FIG. 3 showing a process for modifying the treatment during a treatment session according to some embodiments of the present invention. In some embodiments, the treatment is modified, for example, during a peritoneal dialysis exchange cycle used to refresh the fluid in the peritoneal cavity. In some embodiments, the treatment is modified during the dwell time of the dialysate in the peritoneal cavity. In some embodiments, a peritoneal dialysis filtration process is performed during the dwell time of the dialysate, and waste products and excess water are extracted from the blood.

[0210] According to some exemplary embodiments, at 302, peritoneal dialysis treatment is initiated. In some embodiments, the treatment is a pre-determined treatment, for example, a treatment selected by a physician based on the patient's previous clinical condition. In some embodiments, at 302, a dialysate infusion process or a dialysate drainage process is initiated.

[0211] According to some exemplary embodiments, different parameters are measured at step 304 during the treatment session. In some embodiments, the parameters are measured by a peritoneal dialysis device, for example, device 202. In some embodiments, at 304, the device measures parameters related to the treatment, for example, the duration of fluid flow, fluid pressure, and / or fluid volume. Optionally, the device measures the contents of the fluid, for example, the chemical contents, mineral contents, and / or biological contents of the fluid. Alternatively or in addition, the device measures the patient's clinical parameters, for example, heart rate, body temperature, blood pressure, weight, or any other clinical parameter related to the treatment.

[0212] According to some exemplary embodiments, at 306, an input is received. In some embodiments, the input includes, for example, an input received from the user when the user desires to end the current treatment session and / or when the user is not feeling well during the treatment session. Alternatively or in addition, the input received at 306 includes an input from a physician or a remote expert.

[0213] According to some exemplary embodiments, at 308, the treatment is modified. In some embodiments, the treatment is modified based on the parameters measured at 304 and / or based on the input received at 306. In some embodiments, the treatment is modified by modifying the treatment parameters or by selecting a different treatment plan. In some embodiments, the treatment, which is a pre-determined treatment, is modified to faithfully match the patient's current clinical condition. Alternatively or in addition, the pre-determined treatment is modified to adapt to the current treatment state. In some embodiments, after the treatment is modified at 308, the treatment modified at 302 is initiated.

[0214] Exemplary process for modifying treatment between treatment sessions According to some exemplary embodiments, the peritoneal dialysis treatment is modified between treatment sessions, for example, between the infusion of dialysis fluid into the peritoneal cavity and the drainage of the dialysis fluid. Alternatively or in addition, the treatment is modified between the cycles of infusion and drainage. In some embodiments, the treatment is modified according to measurements between treatment sessions and / or according to an input received between treatment sessions. A possible advantage of modifying the treatment between treatment sessions is, for example, that during the actual treatment, the pre-determined treatment can be adjusted to the patient's clinical condition in order to enable a more individualized treatment. Here, reference is made to FIG. 4 showing a process for modifying treatment between treatment sessions according to some embodiments of the present invention.

[0215] According to some exemplary embodiments, at 402, peritoneal dialysis treatment is determined. In some embodiments, the treatment and / or treatment parameters are determined based on the patient's clinical condition during a pre-treatment examination.

[0216] According to some exemplary embodiments, at 404, the patient is treated according to pre-determined treatment parameters. In some embodiments, at 404, dialysis fluid is infused into the peritoneal cavity. Alternatively or in addition, at 404, the dialysis fluid is drained.

[0217] According to some exemplary embodiments, when the treatment is over, at 406, parameters are measured. In some embodiments, the parameters are measured by a peritoneal dialysis device, such as device 202. In some embodiments, the device measures, at 406, parameters related to the treatment, such as the duration of fluid flow, fluid pressure, and / or fluid volume. Optionally, the device measures the contents of the fluid, such as the chemical contents, mineral contents, and / or biological contents of the fluid. Alternatively or in addition, the device measures the patient's clinical parameters, such as heart rate, body temperature, blood pressure, weight, or any other clinical parameter related to the treatment.

[0218] According to some exemplary embodiments, at 408, an input is received. In some embodiments, the input includes an input received from the user after the treatment, for example, when the user desires to change the schedule of the next treatment session or an event related to another treatment and / or when the user does not feel well after the treatment session. Alternatively or in addition, the input received at 406 includes an input from a physician or a remote expert. In some embodiments, the physician or expert transmits an input based on the patient's treatment compliance or the parameter measurement at 406.

[0219] According to some exemplary embodiments, at 410, the treatment is modified. In some embodiments, the treatment is modified based on the measurements at 406 and / or based on the input received at 408. In some embodiments, at least one treatment session, e.g., a dialysate infusion session or a dialysate drainage session, is modified. In some embodiments, the treatment session is modified after the measurement. Alternatively, an alternative treatment or a different treatment plan is selected. In some embodiments, at 404, the modified treatment is initiated.

[0220] Exemplary process for modifying treatment due to treatment variations According to some exemplary embodiments, a peritoneal dialysis device, e.g., device 202, monitors and controls a peritoneal dialysis treatment. In some embodiments, pre-determined treatment parameters are automatically modified by the device during the treatment. In some embodiments, pre-determined treatment parameters are modified when a variation between the actual treatment and the pre-determined treatment is identified. Reference is now made to FIG. 5, which shows a process for modifying treatment due to treatment variations. In some embodiments, the pre-determined treatment is modified based on variations detected, e.g., in a peritoneal dialysis exchange cycle used to refresh the fluid in the peritoneal cavity. In some embodiments, the pre-determined treatment is modified based on variations detected during the dwell time of the dialysate in the peritoneal cavity. As described herein, the peritoneal dialysis filtration process occurs during the dwell time of the dialysate, and waste products and excess water are extracted from the blood.

[0221] According to some exemplary embodiments, at 502, a treatment plan is determined. In some embodiments, treatment parameters, e.g., the duration of dialysate infusion and / or the duration of dialysate drainage, are determined. Additionally, the volume of dialysate to be infused and the dialysate contents are determined. In some embodiments, at 502, the time interval between dialysate infusions and the dialysate are also determined.

[0222] According to some exemplary embodiments, treatment is initiated at 504. In some embodiments, treatment is initiated according to the treatment parameters determined at 502.

[0223] According to some exemplary embodiments, treatment variations are identified at 506. In some embodiments, a peritoneal dialysis device, such as device 202, identifies variations between a pre-determined treatment and an actual treatment.

[0224] According to some exemplary embodiments, an instruction is delivered at 508. In some embodiments, when treatment variations are identified at 506, an instruction is delivered at 508. In some embodiments, the instruction is delivered to a user of the device, such as a patient or a caregiver. Alternatively, the instruction is delivered to a physician or an expert.

[0225] According to some exemplary embodiments, treatment is modified at 510. In some embodiments, the pre-determined treatment and / or the pre-determined treatment parameters are modified at 510. In some embodiments, the timing parameters of the treatment, such as the duration of dialysate infusion or dialysate drainage, are modified. In some embodiments, the volume of the dialysate to be infused and / or the volume of the dialysate to be drained are modified. In some embodiments, the treatment and / or the treatment parameters are modified automatically or semi-automatically by the device.

[0226] According to some exemplary embodiments, an alternative treatment plan is selected at 512. In some embodiments, the alternative treatment plan is stored in the memory of the device, such as memory 212. In some embodiments, the alternative treatment plan is selected using an algorithm stored in the memory of the device, such as memory 212. In some embodiments, when treatment is modified at 510, the modified treatment is initiated at 504. In some embodiments, when an alternative treatment plan is selected at 512, the alternative treatment plan is initiated at 504.

[0227] Exemplary Process for Monitoring Treatment Compliance According to some exemplary embodiments, for example, to enable better disease management and treatment management, a patient's compliance with peritoneal dialysis treatment is monitored. In some embodiments, treatment compliance is monitored by a peritoneal dialysis device, such as device 202. Reference is now made to FIG. 6, which shows a process for monitoring treatment compliance according to some embodiments of the present invention.

[0228] According to some exemplary embodiments, after treatment is initiated at 504 as described above, it is monitored at 602. In some embodiments, treatment is monitored by a peritoneal dialysis device, such as device 202. In some embodiments, the device monitors treatment using at least one sensor, such as a sensor related to fluid flow or a clinical sensor. Alternatively or in addition, the device monitors the connection of a dialysis fluid bag and / or a drainage bag to the patient's catheter through at least one connector of the device. In some embodiments, the device monitors the formation of a sterilized fluid path connected to the patient's catheter. In some embodiments, the device monitors the interaction between the user and the device, such as the operation of the device, the operation and / or termination of the device. In some embodiments, the device monitors the disconnection of the dialysis fluid bag and / or the drainage bag and / or the drainage catheter from the device. Optionally, the device monitors the connection and disconnection to the fluid processing module 112.

[0229] According to some exemplary embodiments, the device monitors the duration of the treatment and / or the duration of each treatment session and the interval between consecutive treatment sessions. In some embodiments, the device records and stores at least some of the monitored data in the device's memory, such as memory 212.

[0230] According to some exemplary embodiments, the device monitors for any variations from pre-determined treatment parameters and, at 604, records such variations if detected. Optionally, if a variation is detected, the device delivers an instruction and / or report to the user and / or physician.

[0231] According to some exemplary embodiments, at 606, a treatment, e.g., a treatment session, is terminated. In some embodiments, at 608, a compliance report is generated. In some embodiments, the compliance report includes a summary of at least some of the events monitored during the treatment. Alternatively or in addition, the compliance report includes events monitored before and / or after the treatment, e.g., delivery of treatment instructions to the patient and the patient's response to these instructions.

[0232] According to some exemplary embodiments, at 610, the compliance report is stored. In some embodiments, the compliance report is stored in the device's memory. Alternatively, the compliance report is stored in an external memory, e.g., a removable memory or an Internet network remote memory.

[0233] According to some exemplary embodiments, at 612, the compliance report is delivered. In some embodiments, the compliance report is delivered to the patient or caregiver. Alternatively or in addition, the compliance report is delivered to the physician or specialist. In some embodiments, the compliance report is delivered during a scheduled update. Alternatively, the compliance report is delivered on demand.

[0234] According to some exemplary embodiments, at 614, the treatment and / or at least one treatment parameter is modified. In some embodiments, the treatment is modified when the patient is not compliant with the treatment and / or treatment parameters. In some embodiments, the treatment is modified according to the compliance report when the delivered treatment or treatment session is different from the pre-determined treatment. In some embodiments, at 504, the modified treatment is initiated.

[0235] Exemplary process for determining a clinical state based on the drained dialysate contents According to some exemplary embodiments, the dialysate is drained from the subject's peritoneum after a defined dwell time. In some embodiments, the drained dialysate contents are measured, optionally analyzed, for example, to determine the subject's clinical state. In some embodiments, the subject's clinical state is determined based on the drained dialysate contents, the subject's body mass, and optionally, the analysis of the measurement time.

[0236] Reference is now made to FIG. 7A, which shows a general process for determining a subject's clinical state based on drained dialysate, according to some exemplary embodiments of the present invention.

[0237] According to some exemplary embodiments, at 701, the dialysate is drained. In some embodiments, the dialysate is optionally drained from the subject's peritoneal cavity after a desired dwell time. In some embodiments, the dialysate is drained from the peritoneum through a catheter into the tubing of the peritoneal dialysis system.

[0238] According to some exemplary embodiments, at 703, the contents of the drained dialysate are analyzed. In some embodiments, the contents of the drained dialysate are measured by at least one sensor, such as an optical sensor, an electrical sensor, or any other sensor capable of measuring at least one parameter related to the contents of the drained dialysate. In some embodiments, the contents of the drained dialysate are measured over a predetermined time period. In some embodiments, the at least one parameter includes the turbidity level of the drained dialysate, light absorption and / or light scattering at a selected wavelength, the number of white blood cells in the drained dialysate, the level of cytokines, the level of metal ions, the level of chemical or biological compounds, such as dextrose or urea, and / or the level of bioactive compounds. In some embodiments, the measurements are analyzed by a controller of the dialysis system.

[0239] According to some exemplary embodiments, at 705, fresh dialysate is infused into a body cavity of a subject, such as the peritoneum. In some embodiments, the fresh dialysate is infused by connecting a fresh dialysate bag to a peritoneal dialysis system that infuses the fresh dialysate into the peritoneum via a catheter.

[0240] According to some exemplary embodiments, at 707, the contents of the fresh dialysate are analyzed. In some embodiments, the contents of the fresh dialysate passing through the tubing of the peritoneal dialysis tubing are analyzed. Alternatively or in addition, the fresh dialysate in the fresh dialysate bag is analyzed. In some embodiments, at least some of the data related to the contents of the fresh dialysate are downloaded from a website, cloud memory storage, a remote server to the memory of the dialysis system. Optionally, the data is downloaded to the memory by scanning a code, such as a barcode, QR code (registered trademark), or any other code printed on the fresh dialysate bag, bag package, or any document attached to the fresh dialysate bag.

[0241] According to some exemplary embodiments, the content of the fresh dialysate is measured by at least one sensor, e.g., an optical sensor, an electrical sensor, or any other sensor capable of measuring at least one parameter related to the content of the fresh dialysate. In some embodiments, the at least one parameter includes turbidity of the dialysate solution, light absorption and / or light scattering at a selected wavelength, white blood cell count, cytokine levels, metal ion levels, levels of chemical or biological compounds, e.g., dextrose or urea, and / or levels of bioactive compounds.

[0242] According to some exemplary embodiments, at 709, the analysis results and / or measurements of the discharged dialysate content are compared with values or instructions stored in the memory of the dialysis system. In some embodiments, the analysis results and / or measurements of the discharged dialysate content are compared with stored values of at least one parameter of the infused dialysate content. Alternatively, the analysis results and / or measurements of the discharged dialysate content are compared with stored analysis results and / or measurements of previously discharged dialysate, e.g., to determine the progression of the body's symptoms.

[0243] According to some exemplary embodiments, at 711, the physiological state of the subject is determined. In some embodiments, the physiological state of the subject is determined based on the analysis results. In some embodiments, the analysis results and / or measurements of the drained dialysate content are compared with the analysis results and / or measurements of the fresh dialysate. In some embodiments, the physiological state of the subject is determined based on the comparison results. In some embodiments, the physiological state of the subject is determined based on stored instructions, optionally, in comparison with instructions related to different clinical states. Alternatively, the physiological state of the subject is determined based on the identified variations in the analysis results and / or measurements of the drained dialysate. In some embodiments, the variations are between the analysis results and / or measurements and at least one reference value or its indication stored in the previously determined baseline and / or memory of the dialysis system. Additionally, the physiological state is determined based on the body mass or weight of the subject and / or the time at which the measurement was taken.

[0244] According to some exemplary embodiments, the physiological state includes one or more of peritonitis, pre-peritonitis, post-peritonitis, inflammation, pre-inflammation, diabetes, pre-diabetes, and pathological states caused by deficiencies of chemical and / or biological compounds.

[0245] Exemplary process for detection of peritonitis According to some exemplary embodiments, one of the risks of peritoneal dialysis treatment is an inflammatory process also known as peritonitis. In some embodiments, peritonitis is caused by bacteria that enter the peritoneal cavity through the patient's catheter from outside the body. Since peritonitis affects peritoneal dialysis treatment, it is important to attempt to detect and detect peritonitis as early as possible, for example, to enable more efficient treatment of peritonitis. Here, reference is made to FIG. 7B showing a process for detecting and optionally treating peritonitis according to some embodiments of the present invention.

[0246] According to some exemplary embodiments, at 702, clinical parameters of a patient are measured. In some embodiments, the clinical parameters include body temperature, and / or white blood cell count, or any clinical parameter indicative of an inflammatory process. In some embodiments, the clinical parameters of the patient are measured between treatment sessions, during a treatment session, or prior to a dialysate drainage process.

[0247] According to some exemplary embodiments, at 704, dialysate is drained. In some embodiments, for example, a portion of the dialysate is drained during the dwell time to monitor the progress of the filtration process. In some embodiments, a portion of the dialysate is drained at least twice during the dwell time. Optionally, a portion of the dialysate is drained at a predetermined point during the dwell time.

[0248] According to some exemplary embodiments, at 706, dialysate contents are analyzed. In some embodiments, the dialysate contents are analyzed while draining the dialysate. In some embodiments, the dialysate contents are analyzed continuously or at least at two points while draining the dialysate. In some embodiments, the dialysate contents are analyzed by directing a portion of the dialysate into a test tube or a test channel.

[0249] According to some exemplary embodiments, at 706, the chemical and / or biological composition of the drained dialysate is analyzed. In some embodiments, the drained dialysate is analyzed for the amount of white blood cells exceeding a predetermined threshold. Alternatively or in addition, the number of neutrophils or any other white blood cells, which are indicators for peritonitis, is analyzed. Optionally, the presence and / or amount of pro-inflammatory cytokines in the drained dialysate is analyzed.

[0250] According to some exemplary embodiments, at 708, physical characteristics of the drained dialysate are analyzed, such as the turbidity of the drained dialysate. In some embodiments, an increase in cloudiness or haziness of the drained dialysate is an indication of the presence of bacteria and peritonitis. In some embodiments, the turbidity level is measured by a turbidity sensor that measures, for example, the amount of light scattered by solids suspended in the fluid. Optionally, at 708, the light absorption, light scattering, and / or color of the drained dialysate are analyzed.

[0251] According to some exemplary embodiments, if peritonitis is not detected at 710, the draining process ends at 712. According to some exemplary embodiments, if peritonitis is detected at 710, instructions are sent to the patient and / or caregiver and / or physician at 714.

[0252] According to some exemplary embodiments, the draining process ends at 716. In some embodiments, an expert receives instructions at 718. In some embodiments, the expert sends instructions to treat peritonitis and / or modify the dialysis treatment.

[0253] According to some exemplary embodiments, the dialysis treatment is modified at 720. In some embodiments, the dialysis treatment is terminated or postponed after detection of peritonitis. Alternatively, at least one treatment parameter is modified. In some embodiments, the dwell time of the dialysate in the peritoneal cavity is modified. In some embodiments, the patient is instructed to take a sample of the infected drained dialysate to a clinic or laboratory, for example, for analysis by microbial culture. In some embodiments, the dialysis treatment is automatically terminated or automatically postponed by the dialysis device after detection of peritonitis. Alternatively, at least one treatment parameter is automatically modified by the dialysis device.

[0254] According to some exemplary embodiments, at 722, peritonitis is treated. In some embodiments, peritonitis is treated by infusion of a solution containing an antibiotic into the peritoneal cavity. Optionally, the antibiotic is introduced into the dialysate solution prior to the infusion. In some embodiments, for example, peritonitis is treated by flushing the peritoneal cavity at least once with a cleansing solution prior to the dialysate infusion. In some embodiments, peritonitis is automatically treated by a dialysis device, for example, by automatically flushing the peritoneal cavity and / or automatically injecting an antibiotic into the peritoneal cavity.

[0255] Reference is now made to FIG. 7C showing a process for detecting peritonitis by measuring optical parameters, such as light absorption and / or light scattering, according to some exemplary embodiments of the present invention.

[0256] According to some exemplary embodiments, the dialysate is drained from the peritoneal cavity at 740. In some embodiments, the dialysate is drained through the tubing of the dialysis device.

[0257] According to some exemplary embodiments, at 742, the absorption and / or scattering of light passing through the drained dialysate is measured. In some embodiments, the absorption and / or scattering of light passing through the drained dialysate within the tube is measured. Alternatively, the absorption and / or scattering of light passing through the drained dialysate within the drained dialysate storage compartment is measured. Optionally, the measured absorption value and / or scattering value or indication of value of the drained dialysate is stored in a memory, such as memory 212. In some embodiments, the light absorption and / or light scattering is measured by at least one sensor disposed within the PPDS. Optionally, the at least one sensor is part of a durable unit. Alternatively, the at least one sensor is part of a disposable unit. In some embodiments, the at least one sensor measures the absorption and / or scattering of light passing through the drained dialysate within a wavelength range of 500 - 650 nm, such as within a range of 500 - 600 nm, within a range of 550 - 620 nm, within a range of 530 - 630 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range. Additionally or alternatively, at least one additional sensor measures the absorption and / or scattering of light passing through the drained dialysate within a wavelength range of 150 - 350 nm, such as 150 - 250 nm, 200 - 300 nm, 250 - 350 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range. In some embodiments, the additional sensor is configured to measure the absorption and / or scattering of light within the visible light spectrum. In some embodiments, the absorption and / or scattering of light for each wavelength within the wavelength range or for at least one selected wavelength within the wavelength range is measured. In some embodiments, the absorption and / or scattering of light passing through the drain bag of the drained dialysate is measured.

[0258] According to some exemplary embodiments, at 744, a variation in the measured value is identified. In some embodiments, the identified variation is a variation between the measured value and a predetermined baseline, at least one reference value, or an indication thereof optionally stored in the memory of the dialysis system or device.

[0259] According to some exemplary embodiments, at 746, fresh dialysate is introduced into the peritoneum. In some embodiments, the fresh dialysate passes through the tubing of a peritoneal dialysis system, optionally a portable peritoneal dialysis system (PPDS).

[0260] According to some exemplary embodiments, at 750, optical parameters, such as the absorption and / or scattering of light passing through the fresh dialysate, are measured. In some embodiments, the absorption and / or scattering of light is measured by at least one sensor disposed within the PPDS. Optionally, the at least one sensor is part of a durable unit of the PPDS. Alternatively, the at least one sensor is part of a disposable unit of the PPDS. In some embodiments, the at least one sensor measures the absorption and / or scattering of light passing through fresh dialysate within a wavelength range of 500 - 650 nm, such as within a range of 500 - 600 nm, within a range of 550 - 620 nm, within a range of 530 - 630 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range. Additionally or alternatively, at least one additional sensor measures the absorption and / or scattering of light passing through fresh dialysate within a wavelength range of 150 - 350 nm, such as 150 - 250 nm, 200 - 300 nm, 250 - 350 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range. In some embodiments, the additional sensor is configured to measure the absorption and / or scattering of light within the visible light spectrum. In some embodiments, the absorption and / or scattering of light is measured for each wavelength within the wavelength range or for at least one selected wavelength within the wavelength range. In some embodiments, the absorption and / or scattering of light passing through a fresh dialysate bag is measured.

[0261] According to some exemplary embodiments, the absorption value and / or scattering value measured at 744 is stored in memory at 751. Alternatively or in addition, an indication of the value is stored in memory. In some embodiments, the memory is part of the PPDS, for example, the memory 212 of the device 202 shown in FIG. 2. In some embodiments, the light absorption value and / or light scattering value is provided by the manufacturer of the fresh dialysate solution. Optionally, the value is downloaded to memory from the manufacturer's website, for example, by scanning a code on the fresh dialysate bag / box or a code within the package.

[0262] According to some exemplary embodiments, at 752, the measured light absorption value and / or light scattering value or an indication of the dialysate drained is compared with the fresh dialysate. Alternatively or in addition, the measured light absorption value and / or light scattering value or an indication of the value of the drained dialysate is compared with the indication and / or table stored in memory. Optionally, the measured value or indication of the drained dialysate is compared with the stored value or indication of the previously drained dialysate. Comparing the measured parameter value of the drained dialysate with the measured parameter value of the fresh dialysate allows, for example, self-calibration, for example, to minimize variations due to different batches of fresh dialysate.

[0263] According to some exemplary embodiments, at 754, at least one differential parameter value is calculated based on the comparison result. In some embodiments, the differential parameter includes the deviation and / or average deviation of the absorption value and / or scattering value of the fresh dialysate and the absorption value and / or scattering value of the drained dialysate.

[0264] According to some exemplary embodiments, at 756, a score is generated. In some embodiments, the score is generated based on at least one differential parameter value. Alternatively or in addition, the score is generated based on the measured light absorption value and / or light scattering value of the dialysate discharged. In some embodiments, the score is generated based on a combination of the differential parameter value or the measured light absorption value and / or light scattering value and an indication related to at least one clinical parameter of the subject, such as body temperature, treatment regimen, administered drug, age, blood pressure, underlying disease, and / or white blood cell count. In some embodiments, the generated score indicates the level of contamination of the dialysate fluid. Alternatively or in addition, the generated score indicates the number of white blood cells found in the discharged dialysate or in a selected volume of the discharged dialysate, for example, in 1 ml, 10 ml, 100 ml, 1 liter of the discharged dialysate, or in any intermediate volume, smaller volume, or larger volume of the discharged dialysate. In some embodiments, the score is generated individually for each wavelength or for each wavelength range.

[0265] According to some exemplary embodiments, at 758, an indication is delivered. In some embodiments, the indication, for example, an indication detectable by a human, is delivered to the user of the PPDS. Alternatively or in addition, the indication is delivered to a caregiver or an expert, such as a physician. Optionally, the indication is delivered to a remote computer or a handheld device by a wireless signal. In some embodiments, the indication is based on the score generated at 756 and / or the differential value calculated at 754. In some embodiments, the indication is based on the measured light absorption value and / or light scattering value of the discharged dialysate or on an indication of the value.

[0266] According to some exemplary embodiments, at 758, an indication is delivered when the generated score or the calculated differential value is optionally higher than a predetermined value stored in the memory 212 or not within a range of predetermined values.

[0267] According to some exemplary embodiments, at 760, at least one parameter value of the treatment is modified. Alternatively, at 760, at least a part of the treatment protocol is modified. In some embodiments, the parameter value and / or the treatment protocol are modified based on the generated score. Alternatively or in addition, the parameter value and / or the treatment protocol are modified based on the calculated difference value. In some embodiments, the treatment is modified, for example, by including a step of washing the peritoneal cavity. Alternatively or in addition, the treatment is modified by shortening or lengthening the dwell time of the dialysate in the peritoneal cavity. In some embodiments, the treatment is modified by changing the composition of the fresh dialysate used in the process, for example, to a dialysate containing an antibiotic, or to a dialysate containing an antibacterial or antiviral bioactive component or agent.

[0268] According to some exemplary embodiments, at 762, a treatment is selected. In some embodiments, the treatment is selected based on the generated score or based on the calculated difference value. In some embodiments, an antibacterial and / or antiviral drug treatment is selected. In some embodiments, for example, by administering an antibiotic or a bioactive agent, treatment is provided without changing the dialysis treatment regimen.

[0269] According to some exemplary embodiments, with respect to the selection of the treatment at 762 and / or with respect to the modification of the treatment at 760, the light absorption and / or light scattering values are measured within two wavelength ranges, within the range of 500 - 650 nm and within the range of 150 - 350 nm, as shown above. Alternatively, with respect to the selection of the treatment at 762 and / or with respect to the modification of the treatment at 760, the light absorption and / or light scattering values are measured within two wavelength ranges, between 500 - 650 nm and within the visible light spectrum. In some embodiments, the absorption values and / or scattering values within the two wavelength ranges are measured by one, two, or more sensors.

[0270] Exemplary process for optimizing dialysis According to some exemplary embodiments, it is possible to determine the dialysis treatment effect by measuring the chemical composition and / or biological composition of the drained dialysate. In some embodiments, if the dialysis treatment is not effective, at least one treatment parameter, for example, the content of the infused dialysate, is modified. Here, reference is made to FIG. 8 showing a process for optimizing a dialysis treatment according to some embodiments of the present invention.

[0271] According to some exemplary embodiments, at 704, the dialysate is drained from the peritoneal cavity. According to some exemplary embodiments, at 802, the content of the drained dialysate is measured. In some embodiments, at 802, the chemical and / or mineral and / or biological properties of the drained dialysate are measured, for example, the creatinine level, urea level, and ionic strength of the drained dialysate. In some embodiments, the ionic strength of the drained dialysate is a measure of the concentration of ions in the drained solution. In some embodiments, the level or concentration of dextrose in the drained dialysate compared to the optionally infused dialysate is an indicator of ionic strength.

[0272] According to some exemplary embodiments, the content of the drained dialysate is measured by at least one sensor of a peritoneal dialysis device, for example, device 202. In some embodiments, the content of the drained dialysate is measured during the drainage procedure or at least two points during the procedure.

[0273] According to some exemplary embodiments, at 804, a dialysis effect is determined. In some embodiments, the dialysis effect is determined based on the measurement results of the discharged dialysis contents. In some embodiments, if the levels of creatinine and / or urea in the discharged dialysate are below the desired thresholds, the dialysis treatment is not effective. Alternatively or in addition, if the dextrose concentration in the discharged dialysate exceeds the desired threshold compared to the concentration in the optionally infused dialysate, the dialysis treatment has a low effect. In some embodiments, if the levels of creatinine and / or urea in the discharged dialysate are higher than the desired thresholds, the dialysis treatment is effective. Alternatively or in addition, if the dextrose concentration in the discharged dialysate is lower than the desired threshold compared to the concentration in the optionally infused dialysate, the dialysis treatment is effective.

[0274] According to some exemplary embodiments, if the treatment effect is low, at 808, an instruction is delivered. In some embodiments, the instruction is delivered to the patient and / or the caregiver. Alternatively or in addition, the instruction is delivered to the physician.

[0275] According to some exemplary embodiments, to enhance the dialysis treatment effect, the composition of the infused dialysate is modified, for example, by increasing the ion concentration of the infused dialysate. Optionally, the ion concentration is increased by using a dialysate with a higher dextrose concentration. In some embodiments, the number of daily dialysate exchanges for a patient treated with continuous ambulatory peritoneal dialysis (CAPD) or the number of nightly dialysate exchanges for a patient treated with automated peritoneal dialysis (APD) is increased. In some embodiments, the volume of the dialysate in each exchange in CAPD is increased. In some embodiments, to enhance the effect, an additional nocturnal dialysate exchange is added to the CAPD treatment schedule. In some embodiments, to enhance the effect, an additional daytime dialysate exchange is added to the APD treatment schedule.

[0276] According to some exemplary embodiments, the dwell time is increased to enhance the dialysis treatment effect. In some embodiments, the dwell time is the time that the infused dialysate remains in the peritoneal cavity until it is drained. In some embodiments, when the filtration rate through the peritoneum is low, the increase in dwell time enables the filtration process to be extended, for example, to increase the concentration of creatinine or urea in the drained dialysate.

[0277] According to some exemplary embodiments, if the treatment effect is higher than the desired effect, at 814, an instruction is delivered. In some embodiments, the instruction is delivered to the patient and / or caregiver. Alternatively or in addition, the instruction is delivered to the physician.

[0278] According to some exemplary embodiments, the composition of the infused dialysate is modified, for example, by lowering the ion concentration of the infused dialysate, to reach the desired effect. In some embodiments, removing excess water from the body of an end-stage renal disease (ESRD) patient is performed by ultrafiltration. In some embodiments, a high glucose (dextrose) concentration in the dialysate creates an osmotic pressure that causes water to migrate from the blood to the dialysate fluid. Optionally, during this process, the glucose concentration in the dialysate is decreased and increased in the blood.

[0279] According to some exemplary embodiments, the dwell time is shortened to reach the desired effect of the dialysis treatment. In some embodiments, the dwell time is the time period that the infused dialysate remains in the peritoneal cavity until it is drained.

[0280] According to some exemplary embodiments, when the dialysis effect is within the desired range, for example, when the concentration of creatinine and / or urea is within the desired range, at 806, an instruction is delivered to the patient and / or caregiver and / or physician.

[0281] According to some exemplary embodiments, the change in the composition and / or dwell time of the dialysate being infused is based on an alternative treatment plan stored in the memory of device 202. In some embodiments, the device automatically determines a modification of at least one treatment parameter and / or treatment plan to optimize the dialysis treatment. Alternatively, the device proposes a modification of at least one parameter or an alternative treatment plan to the patient and / or caregiver.

[0282] According to some exemplary embodiments, the peritoneal dialysis effect is determined based on a function of Kt / V, where K is the dialyzer clearance of urea, t is the dialysis time, and V is the volume of distribution of urea. Optionally, the volume of distribution of urea is equal to the total body fluid volume of the patient. In some embodiments, the function and / or the values or ranges of values of different function variables are stored in the memory of the device, such as memory 212 of FIG. 2. In some embodiments, the dialysis effect is optionally determined by the controller of the device using a table, or different thresholds of function variables, or machine learning based on the Kt / V function or function result.

[0283] According to some exemplary embodiments, the dialysis effect is determined using software programming and / or device programming and / or device circuitry and / or using a neural network. Alternatively or in addition, the dialysis effect is optionally determined based on a table and / or function and / or rule stored in the memory of the device.

[0284] Exemplary Dialysis Treatment Device Operation Process Reference is now made to FIG. 9A, which shows a process for the operation of a peritoneal dialysis system according to some embodiments of the present invention.

[0285] According to some exemplary embodiments, at 910, the cap of the twin bag 908 is removed. In some embodiments, for example, a manual clamp 902 is added to the twin bag to control the flow into and out of the twin bag. Optionally, two clamps, one for each bag of the twin bag, are added. In some embodiments, a disposable pump tubing 904 is connected to the twin bag. In some embodiments, the twin bag is connected to a device, such as device 202 or device 102. In some embodiments, when the twin bag is connected to the device, a disinfection process is initiated, for example, to disinfect the flow path between the twin bag and the pump tubing.

[0286] According to some exemplary embodiments, at 214, the catheter cap is removed and at 916, a catheter, such as a patient's catheter, is connected to the device. In some embodiments, during the connection of the catheter, a disinfection process is initiated, for example, to disinfect the flow path between the catheter and the pump tubing. In some embodiments, at 918, the clamp on the drain side of the twin bag is closed. In some embodiments, at 920, the disinfection unit is stopped. In some embodiments, at 922, the catheter flow valve is opened. In some embodiments, at 924, the clamp on the drain side is opened, for example, to allow the drained dialysate to enter the drain bag.

[0287] According to some exemplary embodiments, at 926, the pump is activated. In some embodiments, the pump, such as a peristaltic pump, rotates the rotor in the direction towards the drain bag. In some embodiments, the pump remains activated if the drained dialysate flows into the drain bag. In some embodiments, if the drained dialysate does not flow, the pump is stopped at 930.

[0288] According to some exemplary embodiments, at 932, the catheter clamp is closed. In some embodiments, at 934, the seal is broken. In some embodiments, for example, the seal is broken to enable flushing of the dialysate drained from the pump tubing. In some embodiments, at 936, the pump is activated. In some embodiments, the pump is activated for a desired time to flush the pump tubing. In some embodiments, when the desired time has elapsed, at 940, the pump is stopped. In some embodiments, at 942, the drain side clamp is closed. In some embodiments, for example, at 944, the catheter flow valve is opened to enable the flow path between the fresh dialysate bag and the catheter.

[0289] According to some exemplary embodiments, at 946, the pump is activated. In some embodiments, the pump remains activated as long as dialysate is flowing into the catheter. In some embodiments, when the dialysate stops flowing, at 950, the pump is stopped. In some embodiments, for example, at 952, the catheter clamp is closed to separate the catheter from the pump tubing. In some embodiments, at 954, the dialysate clamp is closed. In some embodiments, for example, at 956, the catheter flow valve is closed to prevent any flow to and from the catheter.

[0290] According to some exemplary embodiments, at 958, the catheter clamp is released. In some embodiments, at 960, the catheter is detached or disconnected. In some embodiments, at 962, a cap is attached over the opening of the catheter. In some embodiments, at 964, the disinfection unit is stopped.

[0291] According to some exemplary embodiments, at 966, the drain side clamp is closed. In some embodiments, at 968, the twin bag is removed. In some embodiments, at 970, the drain bag is drained. In some embodiments, at 972, the drain bag is discarded.

[0292] According to some exemplary embodiments, the disposable pump tubing 904 is also disconnected from the device. In some embodiments, a new disposable pump tubing is added to the device between the infusion process and the drainage process.

[0293] Reference is now made to FIG. 9B showing the operation process of a peritoneal dialysis system according to some embodiments of the present invention.

[0294] According to some exemplary embodiments, at 901, the portable peritoneal dialysis disposable part (PPDD) is taken out of the packing. In some embodiments, at 903, the sterility of the PPDD packing is inspected and / or determined. In some embodiments, at 903, the sterility of the packing is determined by inspecting the integrity of the packing. In some embodiments, if the packing is sterile, at 905, the PPDD is taken out of the packing.

[0295] According to some exemplary embodiments, at 907, the PPDD is loaded into the portable peritoneal dialysis machine (PPDM). In some embodiments, the PPDM is the durable part of the device and the PPDD is the disposable part of the device. In some embodiments, at 909, the tubing is taken out of the packing, optionally, the disposable packing. In some embodiments, at 911, the tubing is inspected. In some embodiments, at 913, the "pull ring" is removed from the sterile packing. In some embodiments, the tubing is loaded into the PPDD. Optionally, the tubing is arranged in relation to the pump rotor of the PPDD.

[0296] According to some exemplary embodiments, at 915, the tubing is loaded into the PPDD. In some embodiments, at 917, a catheter cap, e.g., a patient catheter cap, is removed. In some embodiments, at 919, the catheter is loaded into the PPDD. Optionally, during loading of the catheter, the catheter is disinfected by a disinfection connector of the PPDD.

[0297] According to some exemplary embodiments, at 921, the lid of the PPDM is closed. Optionally, closing the lid starts the catheter disinfection process. In some embodiments, at 923, the catheter flow valve is opened. In some embodiments, at 925, a seal, e.g., a "green" seal, is broken. Optionally, breaking the seal releases the disinfection solution to the catheter.

[0298] According to some exemplary embodiments, at 927, the disinfection timer is started. In some embodiments, at 929, the disinfection timer is stopped. In some embodiments, the disinfection timer sets a desired time sufficient to disinfect the flow path between the tubing and the catheter. In some embodiments, at 931, the drain side clamp is opened. In some embodiments, at 933, a pump is activated, e.g., to drain dialysate from the peritoneal cavity. In some embodiments, if fluid is being drained at 935, the pump remains activated. In some embodiments, if there is no fluid to drain, at 937, the pump is stopped.

[0299] According to some exemplary embodiments, at 939, the catheter clamp is closed. In some embodiments, for example, at 941, the pump is activated to sweep out any drained dialysate remaining from the tubing. In some embodiments, at 943, the pump is optionally activated by a timer for at least 2 seconds, such as 2, 3, 4, 5, 6, 7 seconds and / or intermediate times, or for a longer time. Alternatively, the pump is activated until no residual fluid remains in the tubing. In some embodiments, at 945, the pump is stopped. In some embodiments, at 947, the drain side clamp is closed.

[0300] According to some exemplary embodiments, the catheter clamp is released. In some embodiments, the dialysate clamp is released. In some embodiments, for example, at 949, the pump is activated to allow infusion of dialysate into the catheter. In some embodiments, at 951, dialysate flows into the catheter. In some embodiments, the pump remains activated as long as dialysate is flowing into the catheter. In some embodiments, at 953, the pump is stopped when no dialysate is flowing into the catheter. Optionally, the pump is stopped according to the operating parameters of the treatment protocol. In some embodiments, at 955, the catheter clamp is closed. In some embodiments, at 957, the dialysate clamp is closed. In some embodiments, at 959, the catheter flow valve is closed.

[0301] According to some exemplary embodiments, at 961, the lid of the PPDM is opened. In some embodiments, at 963, all clamps are opened. In some embodiments, at 965, the catheter is released from the PPDD. In some embodiments, a cap is attached over the opening of the catheter.

[0302] According to some exemplary embodiments, at 969, the PPDD is removed from the PPDM. In some embodiments, at 971, the rotor is removed from the PPDD. In some embodiments, at 973, the drainage bag is drained. In some embodiments, at 975, the drainage bag is discarded. Optionally, at 975, only the PPDD or the tubing is discarded.

[0303] Interaction and functions of exemplary devices Reference is now made to FIG. 10, showing the interaction and functions of a peritoneal dialysis device according to some embodiments of the present invention.

[0304] According to some exemplary embodiments, the peritoneal dialysis system 1002 comprises a PPDM unit, such as a durable unit 1004, and a PPDD disposable unit 1006. In some embodiments, the durable unit 1004 comprises a case, a power unit, such as a battery, a pump motor, such as an electric pump motor, and a motor interface. In some embodiments, the durable unit further comprises at least one sensor, a communication module, and a controller for controlling, for example, the dialysis treatment process and the motor.

[0305] According to some exemplary embodiments, the disposable unit 1006 comprises a carrier, a connection module, and optionally, an automatic connection module. In some embodiments, the connection module is also a disinfection module. Additionally, the disposable unit 1006 comprises a pump rotor that is shaped and dimensioned to fit the motor interface of the durable unit 1004. In some embodiments, the disposable unit 1006 comprises at least one sensor, such as a clinical sensor for measuring clinical parameters of the treatment and / or clinical parameters of a patient connected to the device 1002.

[0306] According to some exemplary embodiments, device 1002 measures a patient's clinical parameters, such as weight 1008, blood pressure 1010, and / or heart rate 1009. In some embodiments, device 1002 writes the measured parameter values and other information to the device's memory or to remote memory 1012. In some embodiments, device 1002 reads treatment plans and treatment parameters from remote memory 1012. Additionally, the device transmits the stored information to physician 1016 and / or patient 1018. In some embodiments, physician 1016 transmits information, such as a proposed treatment protocol or a proposed protocol modification, to remote memory 1012 or directly to the memory of device 1002.

[0307] Exemplary system Reference is made to FIG. 11 showing a system for the delivery of peritoneal dialysis treatment according to some embodiments of the present invention.

[0308] According to some exemplary embodiments, a portable peritoneal dialysis system (PPDS), such as system 1100, includes at least one bag, such as a dialysate bag 1103, and a bag 1104 for the drained dialysate connected to a connector of device 1102. In some embodiments, different patient catheter tubes 1106 are connected to different connectors of device 1102.

[0309] Reference is made to FIG. 12 showing a system for monitoring and / or controlling peritoneal dialysis treatment according to some embodiments of the present invention.

[0310] According to some exemplary embodiments, a storage compartment 1202 for a new dialysate solution is connected to a connector 1205, such as a y-connector, via a flow breaker 1208. In some embodiments, a storage compartment for used dialysate is connected to the connector 1205 via a flow breaker 1206. In some embodiments, the flow breakers 208 and 1205 are used to close the flow paths between the storage compartments and the connector 1205. In some embodiments, the connector 1205 automatically disinfects the flow paths to each compartment.

[0311] According to some exemplary embodiments, the connector 1205 is disposed at the distal end of pump tubing associated with a rotor of a peristaltic pump 1210. In some embodiments, at least one pressure sensor, such as a pressure sensor 1212, senses the pressure of fluid within the pump tubing. In some embodiments, at least one flow sensor, such as a flow sensor 1214, senses the flow rate and / or fluid volume within the pump tubing. In some embodiments, at least one peritonitis sensor, such as a peritonitis sensor 1216, senses the occurrence of peritonitis within the peritoneal cavity as described above. In some embodiments, the fluid within the pump tubing passes through a heating unit 1218. In some embodiments, the heating unit 1218 heats fresh dialysate fluid within the pump tubing to a desired temperature before being injected into the patient's catheter.

[0312] According to some exemplary embodiments, a patient catheter 1221 is connected to a patient's peritoneal cavity 1222 with a connector 1120. In some embodiments, the connector 1120 is connected to the proximal end of the pump tubing. In some embodiments, the connector 1120 automatically or semi-automatically connects the patient catheter to the proximal end of the pump tubing. Additionally or optionally, the connector 1120 automatically or semi-automatically disinfects the flow path between the patient's catheter and the pump tubing.

[0313] Exemplary Dialysate Test Module Reference is now made to FIGS. 13A-13G, showing dialysis fluid testing means according to some embodiments of the present invention.

[0314] According to some exemplary embodiments, a PPDD unit, e.g., a disposable unit 1301, comprises pump tubing and at least one connector at the tubing ends, e.g., a disinfection connector. In some embodiments, the pump tubing 1302 is associated with a rotor 1308 and comprises at least one connector, e.g., connectors 1304 and 1314 at two ends of the tubing 1302. In some embodiments, flow regulators, e.g., clamps, e.g., flow regulators 1306 and 1312, are disposed on the tubing 1302 adjacent to the connectors. In some embodiments, when the flow regulator is closed, fluid does not flow into or out of the pump tubing. In some embodiments, fluid can flow into and out of the pump tubing only when the flow regulator is at least half open. In some embodiments, at least one flow regulator enables control of the flow of fresh dialysis fluid, e.g., to and / or from a patient's catheter to a drain bag.

[0315] According to some exemplary embodiments, at least one test path, e.g., tubes 1310 and 1309, is fluidly connected to the pump tubing to direct fluid, e.g., from the pump tubing 1302 to at least one of the tubes 1310 or 1309. In some embodiments, some of the test paths are used to test the drained dialysis fluid and some of the test paths, e.g., tube 1309, are used to test the fresh dialysis fluid. In some embodiments, the flow to one of the test paths is controlled by a valve or a flow regulator. Optionally, the valve or flow regulator is automatically or semi-automatically controlled by a peritoneal dialysis device, e.g., device 202.

[0316] According to some exemplary embodiments, for example, as shown in FIGS. 13D and 13E, each of the test paths, for example, tubes 1326 and 1328 of the disposable unit 1316, comprises a scale, for example, scales 1330 and 1331. In some embodiments, a scale, for example, a color scale, is used to visually estimate the level of a chemical substance and / or a biological element in a fluid using a color reaction. In some embodiments, the color scale includes the color or color indication of the dialysate.

[0317] According to some exemplary embodiments, for example, as shown in FIGS. 13F and 13G, the fluid contents within the test path are analyzed by at least one sensor. In some embodiments, a PPDD unit, for example, the disposable unit 1334 of the device 1332, includes at least one test path, for example, tubes 1337 and 1338. In some embodiments, the disposable unit 1334 is disposed inside a PPDM unit, for example, the durable unit 1336. In some embodiments, the durable unit 1336 comprises at least one sensor such that when the disposable unit 1334 is disposed inside the durable unit 1336, the sensor 1340 is proximal and optionally aligned with at least one test path. In some embodiments, the sensor 1340 optionally measures the absorbance of light at a specific wavelength. In some embodiments, the sensor 1340 is a spectrophotometer. In some embodiments, at least one sensor 1340 measures the absorption and / or scattering of light passing through a test path within a wavelength range of 500 - 650 nm, for example, within a range of 500 - 600 nm, within a range of 550 - 620 nm, within a range of 530 - 630 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range. Additionally or alternatively, the sensor 1340 or at least one additional sensor measures the absorption and / or scattering of light passing through a test path within a wavelength range of 150 - 350 nm, for example, within a range of 150 - 250 nm, 200 - 300 nm, 250 - 350 nm, or within any intermediate wavelength range, within a smaller wavelength range, or within a larger wavelength range.

[0318] According to some exemplary embodiments, at least one sensor or test element is connected to a test path to measure, for example, the chemical and / or biological properties of a fluid flowing into a pump tubing.

[0319] Exemplary disposable unit of a portable peritoneal dialysis device According to some exemplary embodiments, a portable peritoneal dialysis system (PPDS) comprises a portable peritoneal dialysis machine (PPDM), for example, a durable unit, and a portable peritoneal dialysis disposable part (PPDS), for example, a disposable unit. Optionally, the PPDS comprises a portable peritoneal patient management (PPPM) system. In some embodiments, the durable unit comprises a motor, optionally, an electric motor and electrical wiring. In some embodiments, the disposable unit comprises at least one tubule with a connector. In some embodiments, the disposable unit is shaped and dimensioned as a single unit that keeps at least most of the disposable elements, for example, the tubule and at least one connector, enclosed in a housing separate from the durable unit. In some embodiments, the separate housing enables easy assembly of the disposable unit and the durable unit while protecting, for example, the disposable elements of the system. Additionally, the separate housing enables the disposable unit to be sold as a product that can be used immediately without further assembly of the disposable elements by the user.

[0320] Reference is now made to FIGS. 13H - 13M showing a disposable unit of a PPDS with a separate housing according to some exemplary embodiments of the present invention.

[0321] According to some exemplary embodiments, a disposable unit of the PPDS device, for example, the disposable unit 1350, includes a tube 1356 and at least one connector, for example, a Y-set connector 1358 and a catheter connector 1360 present at two ends of the tube 1356. Optionally, at least one of the connectors is a self-sterilizing connector where a sterilizing material interacts with the interface between the two connectors when connected to, for example, an external connector. Additionally, the disposable unit 1350 includes a rotor 1362 having at least one cylindrical contact member, for example, a cylindrical contact member 1363, located at the distal end of the rotor blade. In some embodiments, at least one cylindrical contact member, optionally a rollable cylindrical contact member, is in direct contact with at least a portion of the tube 1356. In some embodiments, the disposable element is disposed within a shaped groove or recess formed in the inner surface of the housing of the disposable unit, for example, a two-piece housing. In some embodiments, the groove or recess is formed in the inner surface of at least one part of the two-piece housing, for example, the base part 1352. In some embodiments, the two-piece housing includes a complementary cover part 1354 shaped and dimensioned to fit the base part 1352. In some embodiments, the cover part 1354 includes a groove or recess that fits at least a portion of the three-dimensional shape or outer profile of the disposable element within the base part 1352.

[0322] According to some exemplary embodiments, as shown in FIG. 13I for example, the base part 1352 and the cover part are assembled to the housing 1352 of the disposable unit 1350. In some embodiments, the axial length 1366 of the housing 1352 is at least 10 cm, for example, 12 cm, 15 cm, 19 cm, 20 cm, 25 cm, or any intermediate value, smaller value, or larger value. In some embodiments, the width 1364 of the housing 1351 is at least 1 cm, for example, 1.5 cm, 2 cm, 2.5 cm, or any intermediate value, smaller value, or larger value.

[0323] According to some exemplary embodiments, the housing is shaped so that it can be easily assembled to the durable unit and / or can be easily assembled to at least one connector of the disposable unit using an external tube. In some embodiments, for example, as shown in FIG. 13J, the outer surface of the cover portion 1354 has at least one mark for indicating the assembly direction of the external tube to the connector of the disposable unit and / or the assembly direction of the disposable unit to the durable unit in order to reduce assembly errors due to improper alignment. In some embodiments, at least one mark 1353 indicates, for example, the cover portion. In some embodiments, the cover portion 1354 includes an opening, for example, opening 1355, above the rotor. In some embodiments, the opening 1355 enables, for example, viewing the rotation direction of the rotor.

[0324] According to some exemplary embodiments, for example, as shown in FIG. 13K, the base portion 1352 includes an opening 1368 that is shaped and dimensioned to allow the motor shaft of the durable unit to pass through. In some embodiments, the motor shaft passes through the opening 1368 and is connected to the rotor, optionally to a disposable rotor within the housing of the disposable unit.

[0325] According to some exemplary embodiments, for example, as shown in FIG. 13L, the cover portion 1354 of the housing is mechanically connected to the base portion 1352 of the housing via at least two connecting members 1372 and 1374, for example, via at least two threaded fasteners or screws. In some embodiments, the threaded fasteners include screws and / or bolts. In some embodiments, the two connecting members include pins. In some embodiments, each of the at least two connecting members penetrates through an opening in the cover portion, for example, opening 1365, and into an opening in the base portion, for example, base portion opening 1376. Optionally, the base portion opening includes an internal thread complementary to the external thread on the connecting member.

[0326] According to some exemplary embodiments, for example, as shown in FIG. 13L, each blade of the rotor 1362, for example, blade 1361, is connected to a cylindrical contact member, for example, cylindrical contact member 1363, by pins, screws, or bolts that are shaped and dimensioned to pass through the openings of the rotor blade and the openings of the cylindrical contact member 1363.

[0327] According to some exemplary embodiments, for example, as shown in FIG. 13M, the assembled disposable unit 1350 has openings 1351 and 1352 in the housing, which are at least two openings. In some embodiments, one opening 1353 is shaped and dimensioned to connect a catheter to the catheter connector 1360, and optionally, the second opening 1351 is shaped and dimensioned to connect the Y-set connector 1358. In some embodiments, at least one mark on the outer surface of the housing indicates, for example, the assembly direction and / or orientation of the disposable unit to the durable unit.

[0328] Exemplary Assembly of Disposable Unit and Durable Unit Reference is now made to FIGS. 13N - 13P, which show the assembly of the disposable unit to the durable unit according to some exemplary embodiments of the present invention.

[0329] According to some exemplary embodiments, a durable unit, e.g., durable unit 1380, optionally includes an inner liner, e.g., a door 1382 with alignment slots 1384 optionally attached to the inner surface of the door 1382. In some embodiments, at least a portion of the door 1382 is transparent, e.g., to enable visualization of a rotor of a disposable unit or a disposable unit disposed inside the durable unit. In some embodiments, a disposable unit, e.g., disposable unit 1350, is shaped and sized to be inserted into the alignment slots 1384, e.g., as shown in FIG. 13N. In some embodiments, the disposable unit 1350 is inserted into the alignment slots in a direction and / or orientation indicated by at least one mark on the housing of the disposable unit 1350, e.g., the mark 1353 shown in FIG. 13J.

[0330] According to some exemplary embodiments, after the disposable unit 1350 is inserted into the alignment slots 1384, the door 1382 is closed. In some embodiments, an external connector is connected to the Y-set connector 1358 through the opening 1351 before the door 1382 is closed or before the disposable unit 1350 is inserted into the alignment slots 1384.

[0331] According to some exemplary embodiments, when the door 1382 is closed, e.g., as shown in FIG. 13O, a drawer of the durable unit 1380, e.g., drawer 1386, is pulled out from the housing of the durable unit. Optionally, the drawer 1386 is automatically pulled out when the door 1382 is closed. In some embodiments, the drawer 1386 includes upper and side openings 1385, optionally a U-shaped side opening, for disposing the catheter tip 1390.

[0332] According to some exemplary embodiments, when the drawer 1386 is closed, the catheter tip 1390 is pushed into the catheter connector 1360. In some embodiments, when the catheter is connected through the catheter connector 1360, optionally, the disinfection process is automatically initiated by the dialysis device 1381.

[0333] According to some exemplary embodiments, the dialysis device 1381 operates a motor, such as an electric motor, to move a disinfection material through the tubing of the disposable unit and to move dialysis fluid through a catheter connected to the system and into and out of the patient's peritoneal cavity. In some embodiments, the dialysis device comprises at least one battery, optionally a rechargeable battery. In some embodiments, for example, as shown in FIG. 13P, the dialysis device 1381 comprises a charging plug 1392 for connecting an external power source to a rechargeable battery to enable charging of the battery, for example. Alternatively, connection of an external power source to the dialysis device enables operation of the device using the external power source instead of or in addition to the battery.

[0334] According to some exemplary embodiments, the housing of the dialysis device 1381 comprises at least one adapter for connecting, for example, a belt or harness to the dialysis device. In some embodiments, the belt or harness is used to secure the dialysis device to a body part of the patient, such as the patient's hand, leg, shoulder, thigh, and / or waist.

[0335] According to some exemplary embodiments, a dialysis device, such as dialysis device 1381, the dialysis device 102 shown in FIG. 1, or the dialysis device 202 shown in FIG. 2, is portable and configured to be secured to a patient's body part by a belt, harness, or any adapter. In some embodiments, the dialysis device comprises a durable unit including a motor, such as an electric motor, and a battery, optionally a rechargeable battery electrically connected to the rotor. In some embodiments, the durable unit comprises a control circuit electrically connected to the motor and to the battery. In some embodiments, the control unit controls the operation of the motor according to the power level of the battery. In some embodiments, the durable unit comprises an interface connected to the control circuit configured to provide at least one human-detectable indication, such as a warning signal by a light indication and / or a sound indication. In some embodiments, when the power level of the battery is lower than a predetermined value, the control circuit signals the interface to generate a warning signal, such as a signal indicating to charge the battery or replace the battery. Alternatively or in addition, when the power level of the battery is lower than a predetermined value, the control circuit stops the operation of the motor.

[0336] According to some embodiments, the control circuit operates the motor in a power-saving mode, for example, when the power level of the battery is lower than a predetermined value. In some embodiments, when optionally operating the motor in a power-saving mode, the control circuit modifies at least one operating parameter of the motor, such as the rotational speed and / or the rotation duration. In some embodiments, the control circuit prevents the operation of the motor when the power level of the battery is lower than a predetermined value.

[0337] According to some embodiments, the power level of the battery when fully charged is sufficient for at least one dialysis treatment session, for example, two treatment sessions, three treatment sessions, four treatment sessions, or any smaller number, intermediate number, or larger number of treatment sessions. In some embodiments, a treatment session includes at least partially draining dialysate from the peritoneal cavity and at least partially injecting fresh dialysate into the peritoneal cavity. Alternatively, a treatment session includes at least partially draining dialysate from the peritoneal cavity, at least partially injecting fresh dialysate into the peritoneal cavity, and a dwell time of the dialysate within the peritoneal cavity.

[0338] Optionally, the dialysis device does not include a heater, such as a dialysate heater. In some embodiments, the dialysis device does not include a heater in order to, for example, conserve battery power and / or reduce the total weight of the dialysis system.

[0339] According to some embodiments, the weight of the dialysis device is in the range of 500 gr to 5 kg (5000 gr), for example, 1 kg, 1.5 kg, 2 kg, 2.5 kg, or any intermediate weight, smaller weight, or larger weight. Optionally, the weight of the dialysis system is less than 4000 gr. In some embodiments, the length of the device is in the range of 100 mm to 450 mm, for example, 100 mm, 150 mm, 170 mm, 200 mm, or any intermediate value, smaller value, or larger value. In some embodiments, the width of the device is in the range of 80 mm to 300 mm, for example, 100 mm, 130 mm, 150 mm, or any intermediate value, smaller value, or larger value.

[0340] According to some embodiments, the dialysis device includes at least one connecting member, such as a harness, belt, or adapter, configured to secure the system to at least one body part of the patient, such as the waist, leg, shoulder, or thigh.

[0341] Exemplary peritoneal dialysis system having removable modules Reference is now made to FIGS. 14A and 14B, which illustrate a peritoneal dialysis cycler base according to some embodiments of the present invention.

[0342] According to some exemplary embodiments, a peritoneal dialysis cycler base, such as cycler base 1402, includes a base with a control unit 1407 and a tubing connector 1403 that enables fluid connection of, for example, at least one bag, such as bags 1406 and 1404, to the cycler base 1402. In some embodiments, each of the bags is connected to the cycler base 1402 by a hook or anchor mechanism that prevents removal of the bag from the cycler base. In some embodiments, the cycler base 1402 includes a temperature monitoring and / or control module, such as module 1409, for monitoring the temperature of the fluid within the bag and / or for heating the fluid if necessary.

[0343] According to some exemplary embodiments, the cycler base 1402 is controlled automatically or semi-automatically by the control unit 1407. In some embodiments, the cycler base controls the temperature of the fluid within the bag or the fluid flowing through the tubing.

[0344] Reference is now made to FIGS. 14C and 14D, which illustrate a removable, optionally portable peritoneal dialysis device according to some embodiments of the present invention.

[0345] According to some exemplary embodiments, the removable dialysis device 1408 comprises at least two connectors for the infusion tube 1412 and for the drain tube 1414, and at least one connector for fluidly connecting the dialysis device 1408 to the tubing connector 1403 of the cycler base 1402. In some embodiments, when a treatment session, e.g., an infusion or a drain session, ends, the patient disconnects the tube 1416 that fluidly connects the removable device 1408 and the cycler base 1402. In some embodiments, the removable device 1408 is connected to the cycler base 1402 by a wireless connection, e.g., Wi-Fi, Bluetooth®, or an infrared connection. Alternatively, the removable device 1408 is connected to the cycler base 1402 by a communication plug.

[0346] According to some exemplary embodiments, the removable device 1408 receives information from the control unit 1407 of the cycler device 1402 regarding the number of bags connected to the cycler device and / or their contents. In some embodiments, the removable device 1408 selects a specific bag for dialysate infusion from the bags connected to the cycler base 1402 based on a determined treatment protocol or in accordance with determined treatment parameters. In some embodiments, when draining the dialysate, the removable device 1408 signals the cycler base 1402 to direct the flow of the fluid being drained to a selected bag connected to the cycler base.

[0347] During the term of the patent rights arising from this application, it is expected that many related devices for monitoring and controlling peritoneal dialysis treatment will be developed, and the scope of the term peritoneal dialysis device is intended to empirically include all such new technologies.

[0348] As used herein in connection with a quantity or value, the term "about" means "within ± 10% of".

[0349] The terms "comprise", "include", "have", and their conjugations mean "including but not limited to".

[0350] The term "consisting of" means "including and limited to".

[0351] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or parts only if they do not substantially change the basic novel features of the claimed composition, method, or structure.

[0352] As used herein, the singular forms ("a", "an", and "the") include references to the plural unless the context clearly dictates otherwise. For example, the term "compound" or "at least one compound" may include a plurality of compounds including mixtures thereof.

[0353] Throughout this application, embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as limiting the scope of the invention in a rigid manner. Accordingly, the description of a range should be considered to specifically disclose all possible sub-ranges as well as the individual numerical values within that range. For example, a description of a range such as "1 to 6" should be considered to specifically disclose sub-ranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc., as well as the individual numerical values within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0354] Whenever a numerical range (e.g., "10 - 15", "from 10 to 15", or any pair of numbers bound by another such range indication) is set forth in this specification, it is intended to include any number (fractional or integral) within the indicated range bounds, including the bounds, unless the context clearly dictates otherwise. The phrases "range / ranging between / within the range of" a first indicated number and a second indicated number and "range / ranging from / to the range of" a first indicated number to a second indicated number (or another such term indicating a range) are used interchangeably herein and are intended to include the first and second indicated numbers and all fractional and integral numbers therebetween.

[0355] Unless otherwise specified, the numbers used in this specification and any numerical ranges based thereon are approximations within the precision of reasonable measurement and rounding errors as would be understood by one of ordinary skill in the art.

[0356] As used herein, the term "method" refers to a manner, means, technique, and procedure for accomplishing a given task, including, but not limited to, manners, means, techniques, and procedures known to or readily developed from known manners, means, techniques, and procedures by practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine.

[0357] As used herein, the term "treating" includes halting, substantially suppressing, delaying, or reversing the progression of a symptom, substantially alleviating the clinical or aesthetic state of a symptom, or substantially preventing the manifestation of the clinical or aesthetic state of a symptom.

[0358] It will be appreciated that certain features of the invention described in connection with separate embodiments for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in connection with a single embodiment for brevity may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Specific features described in connection with various embodiments should not be considered essential features of those embodiments unless the embodiments are inoperative without those elements.

Claims

1. An apparatus for monitoring and / or modifying a patient's peritoneal dialysis treatment, comprising: a memory storing at least one treatment protocol; a control circuit connected to the memory, the control circuit being configured to: receive an instruction to execute the following treatment protocol; measure the characteristics of light passing through fresh peritoneal dialysis fluid; measure the characteristics of light passing through the drained peritoneal dialysis fluid; compare the characteristics of light passing through fresh peritoneal dialysis fluid with the characteristics of light passing through the drained peritoneal dialysis fluid; and determine the patient's physiological state based on the comparison; generate a compliance report for the patient, the compliance report for the patient including the patient's physiological state; provide a recommendation for an alternative treatment protocol or a recommendation for modifying at least one treatment parameter of the treatment protocol based on the compliance report for the patient, the modification including a modification of the content of the fresh peritoneal dialysis fluid; An apparatus configured to perform the above.

2. The apparatus according to claim 1, further comprising tubing shaped and dimensioned to flow fluid to a catheter, the control circuit modifying the peritoneal dialysis treatment based on the flow of the fluid and / or based on the content of the fluid within the tubing.

3. The apparatus according to claim 2, comprising a pump rotor associated with the tubing, the pump rotor being configured to move the fluid, the control circuit modifying the peritoneal dialysis treatment by modifying the rotation of the pump rotor.

4. The apparatus according to claim 1, wherein the comparison further comprises comparing measured parameter values of the drained peritoneal dialysis fluid and parameter values of fresh peritoneal dialysis fluid to enable self-calibration of the apparatus.

5. The apparatus according to claim 1, wherein the comparison generates a score or differential parameter value indicative of the number of white blood cells found in the drained peritoneal dialysis fluid or in a selected volume of the drained peritoneal dialysis fluid.

6. The apparatus according to claim 1, wherein the comparison generates a score individually for each wavelength or each wavelength range.

7. The device according to claim 1, wherein the control circuit is configured to detect peritonitis based on the comparison.

8. The device according to claim 1, wherein at least one optical sensor is connected to the control circuit to measure absorption and / or scattering of light passing through the drained and / or fresh peritoneal dialysis fluid at one or more wavelengths in at least one range of 500 to 650 nm and 150 to 350 nm.

9. The device according to claim 4, wherein the self-calibration is employed to minimize variations due to different batches of fresh peritoneal dialysis fluid.

10. The device according to claim 1, wherein the control circuit modifies the peritoneal dialysis treatment, or modifies at least one treatment parameter, or selects a different treatment protocol stored in the memory based on the comparison.

11. The device according to claim 1, wherein the characteristic includes at least one of light absorption, light scattering, fluid turbidity, or a combination thereof.

12. The device according to claim 1, wherein the comparison generates a score based on at least one clinical parameter of the subject.

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