DIALYSIS SYSTEM HAVING A DISINFECTION UNIT

Abstract

A peritoneal dialysis (PD) system includes a PD machine including a housing, a PD fluid pump housed by the housing, a plurality of PD fluid lines, and a plurality of PD fluid line connectors positioned and arranged at the housing to accept distal ends of the PD fluid lines to perform a disinfection sequence. The PD system also includes a disinfection unit including a disinfection unit housing, a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for the disinfection sequence, a line extending from the disinfection unit housing for connecting to one of the PD fluid line connectors of the PD machine for the disinfection sequence, and a disinfection fluid pump housed by the disinfection unit for pumping disinfection fluid during the disinfection sequence.

Claims

1. A peritoneal dialysis (PD) system comprising: a PD machine including a housing, a PD fluid pump housed by the housing, a plurality of PD fluid lines, and a plurality of PD fluid line connectors positioned and arranged at the housing to accept distal ends of the PD fluid lines to perform a disinfection sequence; and a disinfection unit including a disinfection unit housing, a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for the disinfection sequence, a line extending from the disinfection unit housing for connecting to one of the PD fluid line connectors of the PD machine for the disinfection sequence, and a disinfection fluid pump housed by the disinfection unit for pumping disinfection fluid during the disinfection sequence.

2. The PD system of claim 1, wherein the PD fluid pump is set to a free-flow position during the disinfection sequence.

3. The PD system of claim 1, wherein the PD fluid pump is operated at a slow speed during disinfection.

4. The PD system of claim 1, wherein the disinfection unit includes a control unit configured to cause the disinfection fluid pump to pump the disinfection fluid during the disinfection sequence at 200 ml/min to 500 ml/min.

5. The PD system of claim 4, wherein the disinfection unit includes at least one pressure sensor positioned and arranged to sense a pressure of the disinfection fluid during the disinfection sequence, the at least one pressure sensor having a pressure sensor output to the disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one pressure sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired pressure or within a desired pressure range during the disinfection sequence.

6. The PD system of claim 4, wherein the PD machine includes a PD machine control unit in data communication with the disinfection unit control unit, the PD machine further including at least one pressure sensor positioned and arranged to sense a pressure of the disinfection fluid in the PD machine during the disinfection sequence, the at least one pressure sensor having a pressure sensor output delivered via the data communication to the disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one pressure sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired pressure or within a desired pressure range during the disinfection sequence.

7. The PD system of claim 1, wherein the disinfection unit includes a control unit and a heater under control of the disinfection unit control unit to cause the disinfection fluid heater to heat the disinfection fluid during the disinfection sequence to 70 C. to 110 C.

8. The PD system of claim 7, wherein the disinfection unit includes at least one temperature sensor positioned and arranged to sense a temperature of the disinfection fluid during the disinfection sequence, the at least one temperature sensor having a temperature sensor output to the disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one temperature sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired temperature or within a desired temperature range during the disinfection sequence.

9. The PD system of claim 7, wherein the PD machine includes a PD machine control unit in data communication with the disinfection unit control unit, the PD machine further including at least one temperature sensor positioned and arranged to sense a temperature of the disinfection fluid in the PD machine during the disinfection sequence, the at least one temperature sensor having a temperature sensor output delivered via the data communication to the disinfection unit control unit, and wherein the disinfection unit control unit is configured to use the at least one temperature sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired temperature or a desired temperature range during the disinfection sequence.

10. The PD system of claim 7, wherein the PD machine includes a heater, and wherein the PD machine heater is not powered during the disinfection sequence.

11. The PD system of claim 7, wherein the PD machine includes a heater, and wherein the PD machine heater is provided with a low amount of power during the disinfection sequence.

12. The PD system of claim 1, wherein the disinfection unit includes a switch configured such that a manual actuation of the switch causes the disinfection fluid pump to begin pumping the disinfection fluid.

13. The PD system of claim 1, wherein the PD machine includes a PD machine control unit and the disinfection unit includes a disinfection unit control unit in data communication with the PD machine control unit, and wherein the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to begin pumping the disinfection fluid.

14. The PD system of claim 13, wherein the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to begin pumping the disinfection fluid after receiving confirmation that plural disinfection sequence steps have been completed.

15. A peritoneal dialysis (PD) system comprising: a PD machine including a housing, a PD fluid pump housed by the housing, a patient line in fluid communication with the PD fluid pump, a patient line connector positioned and arranged at the housing to accept a distal end of the patient line to perform a disinfection sequence, a plurality of PD fluid lines, and a plurality of PD fluid line connectors positioned and arranged at the housing to accept distal ends of the PD fluid lines to perform the disinfection sequence; and a disinfection unit including a disinfection unit housing, a PD fluid line connector positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for the disinfection sequence, a line extending from the disinfection unit housing for connecting to one of the PD fluid line connectors of the PD machine for the disinfection sequence, and a disinfection fluid pump housed by the disinfection unit for pumping disinfection fluid during the disinfection sequence.

16. The PD system of claim 15, wherein the patient line is a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen.

17. The PD system of claim 15, wherein at least one of the patient line, the plurality of PD fluid lines or the line extending from the disinfection unit housing is a flexible line.

18. A peritoneal dialysis (PD) system comprising: a PD machine including a PD machine control unit, a PD fluid pump under control of the PD machine control unit; and a disinfection unit configured to be placed in disinfection fluid communication with the PD machine, the disinfection unit including a disinfection unit control unit configured to be placed in data communication with the PD machine control unit, and a disinfection fluid pump under control of the disinfection unit control unit, wherein the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to begin pumping disinfection fluid in a disinfection sequence.

19. The PD system of claim 18, wherein the PD machine control unit is configured to automatically command the disinfection unit control unit to cause the disinfection fluid pump to begin pumping the disinfection fluid after receiving confirmation that plural disinfection sequence steps have been completed.

20. The PD system of claim 18, wherein the disinfection unit includes a switch configured such that an actuation of the switch causes the disinfection fluid pump to begin pumping the disinfection fluid.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0052] FIG. 1 is a fluid flow schematic of one embodiment for a medical fluid, e.g., PD fluid, system in a treatment state.

[0053] FIG. 2 is a fluid flow schematic of one embodiment for a medical fluid, e.g., PD fluid, system in a disinfection state using a disinfection unit of the present disclosure.

DETAILED DESCRIPTION

[0054] Referring now to the drawings and in particular to FIG. 1, a medical system having the enhanced disinfection of the present disclosure is illustrated via peritoneal dialysis (PD) system 10. System 10 includes a PD machine or cycler 20 and a control unit 100 having one or more processor 102, one or more memory 104, video controller 106 and user interface 108. User interface 108 may alternatively or additionally be a remote user interface, e.g., via a tablet or smartphone. Control unit 100 may also include a transceiver and a wired or wireless connection to a network (not illustrated), e.g., the internet, for sending treatment data to and receiving prescription instructions/changes from a doctor's or clinician's server interfacing with a doctor's or clinician's computer. The transceiver is also used for communication with a disinfection unit 110 as discussed herein. Control unit 100 in an embodiment controls all electrical fluid flow and heating components of PD machine or cycler 20 and receives outputs from all sensors of the PD machine. System 10 in the illustrated embodiment includes durable and reusable components that contact fresh and used PD fluid, which necessitates that PD machine or cycler 20 be disinfected between treatments, e.g., via heat disinfection.

[0055] System 10 in FIG. 1 includes an inline resistive heater 56, reusable supply lines or tubes 52a1 to 52a4 and 52b, air trap 60 operating with respective upper and lower level sensors 62a and 62b, air trap valve 54d, vent valve 54e located along vent line 52e, reusable line or tubing 52c, PD fluid pump 70, temperature sensors 58a and 58b, pressure sensors 78a, 78b1, 78b2 and 78c, reusable patient tubing or lines 52f and 52g having respective valves 54f and 54g, a dual lumen patient line 28, a hose reel 80 for retracting patient line 28, reusable drain tubing or line 52i extending to drain line connector 34 and having a drain line valve 54i, and reusable recirculation disinfection tubing or lines 52r1 and 52r2 operating with respective disinfection valves 54r1 and 54r2. A third recirculation or disinfection tubing or line 52r3 extends between disinfection or PD fluid line connectors 30a and 30b for use during disinfection. A fourth recirculation or disinfection tubing or line 52r4 extends between disinfection connectors 30c and 30d for use during disinfection.

[0056] System 10 further includes PD fluid containers or bags 38a to 38c (e.g., holding the same or different formulations of PD fluid), which connect to distal ends 24e of reusable PD fluid lines 24a to 24c, respectively. System 10d further includes a fourth PD fluid container or bag 38d that connects to a distal end 24e of reusable PD fluid line 24d. Fourth PD fluid container or bag 38d may hold the same or different type (e.g., icodextrin) of PD fluid than provided in PD fluid containers or bags 38a to 38c. Reusable PD fluid lines 24a to 24d extend in one embodiment through apertures (not illustrated) defined or provided by housing 22 of PD machine or cycler 20.

[0057] System 10 in the illustrated embodiment includes four disinfection or PD fluid line connectors 30a to 30d for connecting to distal ends 24e of reusable PD fluid lines 24a to 24d, respectively, during disinfection. System 10 also provides a patient line connector 32 that includes an internal lumen, e.g., a U-shaped lumen, which for disinfection directs fresh PD fluid from one PD fluid lumen of a connected distal end 28e of dual lumen patient line 28 into the other PD fluid lumen. Reusable supply tubing or lines 52a1 to 52a4 communicate with reusable supply lines 24a to 24d, respectively. Reusable supply tubing or lines 52a1 to 52a3 operate with valves 54a to 54c, respectively, to allow PD fluid from a desired PD fluid container or bag 38a to 38c to be pulled into cycler 20. Three-way valve 94a in the illustrated example allows for control unit 100 to select between (i) 2.27% (or other) glucose dialysis fluid from container or bag 38b or 38c and (ii) icodextrin from container or bag 38d. In the illustrated embodiment, icodextrin from container or bag 38d is connected to the normally closed port of three-way valve 94a.

[0058] System 10 is constructed in one embodiment such that drain line 52i during a patient fill is fluidly connected downstream from PD fluid pump 70. In this manner, if drain valve 54i fails or somehow leaks during the patient fill of patient P, fresh PD fluid is pushed down disposable drain line 36 instead of used PD fluid potentially being pulled into pump 70. Disposable drain line 36 is in one embodiment removed for disinfection, wherein drain line connector 34 is capped via a cap 34c to form a closed disinfection loop. PD fluid pump 70 may be an inherently accurate pump, such as a piston pump, or less accurate pump, such as a gear pump that operates in cooperation with a flowmeter (not illustrated) to control fresh and used PD fluid flowrate and volume.

[0059] System 10 may further include a leak detection pan 82 located at the bottom of housing 22 of cycler 20 and a corresponding leak detection sensor 84 outputting to control unit 100. In the illustrated example, system 10 is provided with an additional pressure sensor 78c located upstream of PD fluid pump 70, which allows for the measurement of the suction pressure of pump 70 to help control unit 100 more accurately determine pump volume. Additional pressure sensor 78c in the illustrated embodiment is located along vent line 52e, which may be filled with air or a mixture of air and PD fluid, but which should nevertheless be at the same negative pressure as PD fluid located within PD fluid line 52c.

[0060] System 10 in the example of FIG. 1 includes redundant pressure sensors 78b1 and 78b2, the output of one of which is used for pump control, while the output of the other pressure sensor is a safety or watchdog output to make sure the control pressure sensor is reading accurately. Pressure sensors 78b1 and 78b2 are located along a line including a third recirculation valve 54r3. System 10 may further employ one or more cross, marked via an X in FIG. 1, which may (i) reduce the overall amount and volume of the internal, reusable tubing, (ii) reduce the number of valves needed, and (iii) allow the portion of the fluid circuitry shared by both fresh and used PD fluid to be minimized.

[0061] System 10 in the example of FIG. 1 further includes a source of acid, such as a citric acid container or bag 66. Citric acid container or bag 66 is in selective fluid communication with second three-way valve 94b via a citric acid valve 54m located along a citric acid line 52m. Citric acid line 52m is connected in one embodiment to the normally closed port of second three-way valve 94b, so as to provide redundant valves between citric acid container or bag 66 and the PD fluid circuit during treatment. The redundant valves ensure that no citric (or other) acid reaches the treatment fluid lines during treatment. Citric (or other) acid is used instead during disinfection.

[0062] Control unit 100 in an embodiment uses feedback from any one or more of pressure sensors 78a to 78c to enable PD machine 20 to deliver fresh, heated PD fluid to the patient at, for example, 14 kPa (2.0 psig) or higher. The pressure feedback is used to enable PD machine 20 to remove used PD fluid or effluent from the patient at, for example, between 5 kPa (0.73 psig) and 15 kPa (2.2 psig), such as 9 kPa (1.3 psig) or higher (more negative). The pressure feedback may be used in a proportional, integral, derivative (PID) pressure routine for pumping fresh and used PD fluid at a desired positive or negative pressure.

[0063] Inline resistive heater 56 under control of control unit 100 is capable of heating fresh PD fluid to body temperature, e.g., 37 C., for delivery to patient P at a desired flowrate. Control unit 100 in an embodiment uses feedback from temperature sensor 58a in a PID temperature routine for pumping fresh PD fluid to patient P at a desired temperature.

[0064] FIG. 1 also illustrates that system 10 includes and uses a disposable filter set 40, which communicates fluidly with the fresh and used PD fluid lumens of dual lumen patient line 28. Disposable filter set 40 includes a disposable connector 42 that connects to a distal end 28e of reusable patient line 28. Disposable filter set 40 also includes a connector 44 that connects to the patient's transfer set. Disposable filter set 40 further includes a hydrophilic filter membrane 46, which may be a sterilizing grade filter, which further filters fresh PD fluid. Disposable filter set 40 is provided in one embodiment as a last chance filter for PD machine 20, which has been heat disinfected between treatments. Any pathogens that may remain after disinfection, albeit unlikely, are filtered from the PD fluid via the hydrophilic filter membrane 46 of disposable filter set 40.

[0065] FIG. 1 illustrates system 10 setup for treatment with PD fluid containers or bags 38a to 38d connected via reusable, flexible PD fluid lines 24a to 24d, respectively. Dual lumen patient line 28 is connected to patient P via disposable filter set 40. Disposable drain line 36 is connected to drain line connector 34. In FIG. 1, PD machine or cycler 20 of system 10 is configured to perform multiple patient drains, patient fills, patient dwells, and a priming procedure, as part of or in preparation for treatment.

[0066] FIG. 2 illustrates system 10 in a disinfection mode. Three of four PD fluid containers or bags 38a to 38d are removed and the corresponding flexible PD fluid lines 24a to 24d are plugged instead in a sealed manner into the corresponding disinfection or PD fluid line connectors 30a to 30d, respectively. Reusable dual lumen patient line 28 is disconnected from disposable filter set 40 (which is discarded), and distal end 28e of dual lumen patient line 28 is plugged sealingly into patient line connector 32. Disposable drain line 36 is removed from drain line connector 34 and discarded. Drain line connector 34 is capped via cap 34c to form a closed disinfection loop 90. PD machine or cycler 20 of system 10 in FIG. 2 is configured to perform a disinfection sequence, e.g., a heat disinfection sequence in which fresh PD fluid is heated to a disinfection temperature, e.g., 70 C. to 90 C., or higher as discussed herein. The heated PD fluid is circulated within closed disinfection loop 90 for an amount of time needed to properly disinfect the fluid components and lines of the disinfection loop.

[0067] To provide good disinfection and heat transfer to each of the lines disinfected, PD fluid pump 70 if used as the primary distinction sequence pump would need to run at a relatively high pumping rate, resulting in risk of cavitation and the wear of the associated pump seals. It is accordingly contemplated not to use PD fluid pump 70, either at all, or as the primary disinfection fluid driving pump during the disinfection sequence.

[0068] FIG. 2 illustrates that system 10 of the present disclosure instead provides a disinfection unit 110, which may be separate from PD machine or cycler 20. Disinfection unit 110 includes a disinfection unit housing 112 holding an additional pump 114, which may be used in addition to or instead of PD fluid pump 70 during disinfection. To that end, disinfection unit pump 114 may be a sturdy pump that is less accurate than PD fluid pump 70, but which may operate at higher flowrates than PD fluid pump 70 without incurring appreciable wear. Disinfection unit pump 114 may for example be a centrifugal pump. The higher flowrate may for example be from 200 milliliters (ml)/min to 500 ml/min. FIG. 2 further illustrates that disinfection unit 110 optionally includes a second, disinfection unit inline heater 116 located within disinfection unit housing 112, which is selected specifically to heat fluid moving at the elevated disinfection flowrates and to heat the disinfection fluid to a temperature specified herein or to a potentially higher disinfection temperature, such as 90 C. to 110 C.

[0069] Disinfection unit 110 in one embodiment includes a PD fluid line connector 118 at disinfection unit housing 112 that accepts a distal end 24e of any desired one of the reusable, flexible PD fluid lines 24a to 24d of PD fluid machine or cycler 20. In the illustrated embodiment, PD fluid line connector 118 accepts distal end 24e of reusable, flexible PD fluid line 24a. Disinfection unit 110 also includes a flexible line 120 that extends from disinfection unit housing 112 to the open PD fluid line connector 30a to 30d located at PD fluid machine or cycler 20. In the illustrated embodiment, flexible line 120 is connected to PD fluid line connector 30a. The two fluid connections to disinfection unit 110 enable the internal lines and fluid components of the disinfection unit to form part of the PD machine or cycler's disinfection loop 90 during the disinfection sequence. Sealed connections to PD fluid line connector 118 and flexible line 120 may be made by the patient or caregiver after treatment when it is time for disinfection.

[0070] Electrical control may be implemented in disinfection unit 110 in a variety of different ways. If only disinfection unit pump 114 is provided, then an on/off button or switch 122 may be provided at disinfection unit housing 112, which the patient or caregiver may switch to on to initiate a disinfection sequence. Disinfection unit 110 includes an alternating current (AC) plug 124 at disinfection unit housing 112 and whatever electronics (within housing 112) are necessary to convert the AC voltage to the disinfection unit pump voltage if necessary. If a disinfection unit heater 116 is also provided, on/off switch 122 may still be provided for the patient or caregiver, however, at least one temperature sensor 126 and a disinfection unit control unit 130 for using an output from one or more temperature sensor 126 as feedback for controlling power to inline heater 116 are provided so that the disinfection fluid, which may be PD fluid, exits disinfection unit 110 to PD machine or cycler 20 at a desired disinfection temperature or within a desired temperature range.

[0071] When needed, disinfection unit 110 may also include one or more pressure sensor 128. The disinfection unit control unit 130 uses an output from the one or more pressure sensor 128 as feedback for controlling disinfection unit pump 114, so that the disinfection fluid exits the disinfection unit to the PD machine or cycler at a desired disinfection pressure or within a desired pressure range. Disinfection unit control unit 130 in the illustrated embodiment may be housed within disinfection unit hosing 112 and include one or more processor 132 and one or more memory 134. Disinfection unit control unit 130 may also include a user interface 136, e.g., a single or multi-line light-emitting diode (LED) or liquid crystal display (LCD), wherein, the control unit may further include a video controller.

[0072] As discussed herein, control unit 100 of PD machine or cycler 20 may also include a transceiver and a wired or wireless connection to a network (not illustrated), e.g., the internet, etc. Control unit 130 of disinfection unit 110 may likewise include a transceiver for wireless communication with control unit 100 of PD machine or cycler 20, e.g., via Bluetooth or Wifi wireless technologies. Alternatively or additionally, control unit 130 may be placed in wired communication with control unit 100, e.g., via an ethernet cable. In an embodiment, instead of the patient or caregiver powering disinfection unit 110 at the time of disinfection, control unit 100 of PD machine or cycler 20 tells control unit 130 of disinfection unit 110 when to power disinfection unit pump 114 and disinfection unit heater 116 if provided, e.g., after control unit 100 of PD machine or cycler 20 has confirmed that the patient or caregiver has made all necessary connections for the disinfection sequence. The patient or caregiver here may accordingly connect disinfection unit 110 to PD machine or cycler 20 as described herein, make all other necessary disinfection connections, and then be free to leave and perform other tasks.

[0073] It is also contemplated to wirelessly transmit the outputs from one or more temperature sensor 58a, 5bb and/or one or more pressure sensor 78a, 78b1, 78b2, 78c of PD machine or cycler 20 to control unit 130 of disinfection unit 110 for use as feedback to control, respectively, the power applied to disinfection unit heater 116 and/or the rate (or other pressure adjusting parameter) of disinfection unit pump 114. In this manner, disinfection fluid, e.g., PD fluid, may be delivered from disinfection unit 110 at the desired disinfection temperature and/or pressure without having to provide corresponding temperature and/or pressure sensors within the disinfection unit.

[0074] During disinfection, control unit 100 of PD machine or cycler 20 is programmed in one embodiment to set PD fluid pump 70, which may be a piston pump, such that it is in a free-flow position where the disinfection fluid may flow through the PD fluid pump without operating the pump. In an alternative embodiment, control unit 100 operates PD fluid pump at a slow or reduced speed during disinfection. Likewise, control unit 100 of PD machine or cycler 20 is programmed in one embodiment to not power inline heater 58 of PD machine or cycler 20 during disinfection if disinfection unit 110 is provided with its own heater 58. In an alternative embodiment, control unit 100 provides a low amount of power to inline heater 58 of PD machine or cycler 20 during disinfection even if disinfection unit 110 is provided with its own heater 116. Control unit 100 may provide full power to inline heater 58 of PD machine or cycler 20 during disinfection if disinfection unit 110 is not provided with its own heater. Here, inline heater 58 of PD machine or cycler 20 is relied upon to heat the disinfection fluid to the desired disinfection temperature.

[0075] After disinfection, the disinfection unit 110 may be left connected to PD machine or cycler 20 until it is time for the next treatment. At that time, the patient or caregiver may (i) disconnect the disinfection unit's flexible line 120 from the PD fluid line connector (e.g., connector 30a) located at PD fluid machine or cycler 20, (ii) disconnect distal end 28e of the reusable, flexible PD fluid line (e.g., line 24a) of PD fluid machine or cycler 20 from the PD fluid line connector 118 of disinfection unit 110, and (iii) connect the disinfection unit's flexible line 120 to the disinfection unit's PD fluid line connector 118. Such disconnection and reconnection closes disinfection unit 110 fluidically and maintains it in a relatively clean and disinfected state. Disinfection unit 110 is then ready for its next use.

[0076] It is contemplated that disinfection unit 110 is relatively small, lightweight and easy to transport to and from PD machine or cycler 20 as needed if it is desired to do so (or could be left sitting next to PD machine or cycler 20). Housing 112 may therefore be provided with a handle for carrying disinfection unit 110. Housing 112 may also be provided with feet for setting disinfection unit 110 next to PD machine or cycler 20. Housing 112 may also be provided with wheels or casters if needed.

[0077] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. It is therefore intended that such changes and modifications be covered by the appended claims. For example, while disinfection unit 110 has been described herein as a unit separate from PD machine or cycler 20, some or all of the components of disinfection unit 110 may be integrated into PD machine or cycler 20 or be packaged in a housing that is merged with housing 22 of PD machine or cycler 20.