Medical fluid therapy machines, including maintenance configurations.

Abstract

To provide a medical fluid therapy machine including a suitable servicing regime.SOLUTION: A medical fluid delivery system includes: a medical fluid delivery machine including a component having at least one of associated output data or associated test data; at least one of a (i) component output replacement limit and a component output soft limit for the component or (ii) a component testing replacement limit or a component testing soft limit for the component; and a computer programmed to store at least one of (i) and (ii), and for (i) analyze the output data to provide a first indication of how well the component is performing relative to the component output replacement limit and the component output soft limit, and for (ii) analyze the test data to provide a second indication of how well the at least one component is testing relative to the component testing replacement limit and the component testing soft limit.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Priority Claim) This application claims priority and the benefit of U.S. Patent Application No. 15 / 688,062, filed on August 28, 2017, entitled "Medical Fluid Therapy Machine Including Servicing Regime Therefore", which in turn claims priority and the benefit of U.S. Provisional Application No. 62 / 403,568, filed on October 3, 2016, entitled "Medical Fluid Therapy Machine Including Servicing Regime Therefore", the contents of each of which are hereby incorporated by reference and relied upon herein.

[0002] The present disclosure generally relates to devices, systems, and methods for medical fluid delivery machines. More specifically, the present disclosure relates to the maintenance of components used in medical fluid delivery machines such as renal failure treatment machines.

Background Art

[0003] Regarding renal failure treatment machines, due to various causes, a person's renal system can cease to function. Renal failure causes several physiological disturbances. Maintaining the balance of water and minerals or excreting the daily metabolic load is no longer possible. Toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in the blood and tissues.

[0004] Renal insufficiency and reduced renal function are treated using dialysis. Dialysis removes waste products, toxins, and excess water from the body that a normally functioning kidney would otherwise remove. Dialysis treatment for the replacement of renal function is important for many people because the treatment is life-saving.

[0005] One type of renal failure treatment is hemodialysis ("HD"), which commonly uses diffusion to remove waste products from a patient's blood. A diffusion gradient occurs across a semi-osmotic dialyzer between the blood and an electrolyte solution called dialysate or dialysate to cause diffusion.

[0006] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from a patient's blood. HF is performed by adding a replacement fluid or replacement fluid (typically 10–90 liters of such fluid) to an extracorporeal circuit between procedures. The replacement fluid and the fluid accumulated by the patient between procedures are ultrafiltered over a series of HF procedures, providing a convective transport mechanism that is particularly beneficial in removing medium and large molecules (in hemodialysis, a small amount of waste is removed along with the fluid obtained between dialysis sessions, however, the solute traction from the removal of its ultrafiltrate is not sufficient to provide convective clearance).

[0007] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusion clearance. HDF uses a dialysate that flows through a dialyzer, similar to standard hemodialysis, to provide diffusion clearance. In addition, an alternative fluid is supplied directly to the extracorporeal circuit to provide convective clearance.

[0008] Most HD (HF, HDF) treatments are performed at a center. The trend toward home hemodialysis ("HHD") exists today, partly because HHD can be performed daily and offers superior therapeutic benefits compared to center-based hemodialysis treatments, which are typically performed two or three times a week. Studies have shown that more frequent treatments remove more toxins and waste products than patients receiving less frequent but possibly longer treatments. Patients receiving more frequent treatments do not suffer as many downcycles as center-based patients who have accumulated two or three days' worth of toxins prior to their treatment. In some areas, the nearest dialysis center may be miles from a patient's home, and door-to-door treatment time may take up a significant portion of the day. HHD can be performed overnight or during the day while the patient is relaxed, working, or otherwise productive.

[0009] Another type of kidney failure treatment is peritoneal dialysis, in which dialysate, also called dialysis fluid, is injected into the patient's peritoneal cavity via a catheter. The dialysis fluid comes into contact with the peritoneum of the peritoneal cavity. Waste products, toxins, and excess fluid pass from the patient's bloodstream through the peritoneum into the dialysis fluid due to diffusion and osmosis; that is, an osmotic gradient occurs across the membrane. The osmotic agent in dialysis provides the osmotic gradient. Used or depleted dialysis fluid is drained from the patient, removing waste products, toxins, and excess fluid from the patient. This cycle is repeated, for example, multiple times.

[0010] There are various types of peritoneal dialysis treatments, including continuous outpatient peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous fluid peritoneal dialysis ("CFPD"). CAPD is a manual dialysis procedure. Here, the patient manually connects an implanted catheter to a drain to allow used or depleted dialysate fluid to be drained from the peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysate to inject fresh dialysate into the patient through the catheter. The patient disconnects the catheter from the bag of fresh dialysate, allowing the dialysate to remain in the peritoneal cavity, and the transfer of waste products, toxins, and excess fluid occurs. After a certain retention cycle, the patient repeats the manual dialysis procedure, for example, four times per day, with each procedure lasting approximately one hour. Manual peritoneal dialysis requires a significant amount of time and effort from the patient and has room for improvement.

[0011] Automated peritoneal dialysis ("APD") is similar to CAPD in that the dialysis procedure involves draining, filling, and retention cycles. However, APD machines typically perform the cycles automatically while the patient is asleep. APD machines free patients from the need to manually perform the procedure cycles and the need to transport supplies during the day. An APD machine is fluidically connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. The APD machine pumps fresh dialysis fluid from the dialysis fluid source through the catheter into the patient's peritoneal cavity. The APD machine also allows the dialysis fluid to remain in the cavity, enabling the transfer of waste, toxins, and excess fluid. The source may include multiple sterile dialysis fluid bags.

[0012] The APD machine pumps used or depleted dialysate from the peritoneal cavity through a catheter into a drain. Like a manual process, several draining, filling, and retention cycles occur during dialysis. The "final filling" occurs at the end of APD and remains in the patient's peritoneal cavity until the next procedure.

[0013] Any of the above modalities performed by machines involve components that wear out over time and require replacement. There is an inherent difficulty in replacing components too frequently, which can lead to excessive costs and repair times for waiting for a complete component failure, interrupting the machine until a component is replaced, disrupting patient treatment schedules, potentially leading to negative patient and physician / clinician perceptions of the machine, and the need for immediate maintenance.

[0014] U.S. Patent No. 7,873,489, titled "Dialysis Machine with Servicing Indicator," discloses one form of maintenance. This form essentially focuses on two factors: the time a component is installed versus the duration it is used. This form sets three limits, including an upper limit on the duration it is used, a lower limit on the time a component is installed, and an upper limit on the duration a component is installed. A component is not eligible for replacement until it reaches its lower limit on the duration it is installed, even if it has met or exceeded the upper limit on the duration it is used. However, regardless of its duration of use, a component will be replaced once it reaches its upper limit on the duration it is installed.

[0015] While the maintenance configuration of U.S. Patent No. 7,873,489 may differ from those existing in the prior art, there is still considered to be substantial room for improvement. [Prior art documents] [Patent Documents]

[0016] [Patent Document 1] U.S. Patent No. 7,873,489 [Overview of the project] [Means for solving the problem]

[0017] The maintenance modalities described herein are applicable, for example, to fluid delivery for plasma exchange, hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), and continuous renal replacement therapy ("CRRT") procedures. The maintenance modalities described herein are also applicable to peritoneal dialysis ("PD") and intravenous drug delivery. These modalities may be referred to herein collectively or substantially individually as medical fluid delivery.

[0018] Furthermore, the maintenance configurations described herein may be used in conjunction with clinical or home-based machines. For example, the system may be employed in an in-center HD, HF, or HDF machine that operates throughout the day. Alternatively, the system may be used in conjunction with a home HD, HF, or HDF machine that operates according to the patient's convenience. One such home system is described in U.S. Patent No. 8,029,454 ("Patent No. 454"), issued on 4 October 2011, titled "High Convection Home Hemodialysis / Hemofiltration And Sorbent System," filed on 4 November 2004, and assigned to the assignee of this application. Another such home system is described in U.S. Patent No. 8,393,690 ("Patent No. 690"), issued on 12 May 2013, titled "Enclosure for a Portable Hemodialysis System," filed on 27 August 2008. The entire contents of each of the above references are incorporated into and relied upon in this specification by reference.

[0019] In one embodiment, a medical fluid delivery machine is provided, including a medical fluid delivery chassis. The medical fluid delivery chassis houses components necessary for delivering medical fluids, such as one or more pumps, multiple valves, optionally heaters, multiple sensors such as one, more, or all of the following, as needed and desired: a direct-connection medical fluid generating device, a user interface, and a control unit that may employ one or more processors and memory for controlling the devices described above. The medical fluid delivery machine may also include one or more filters, such as a dialyzer or hemofilter for cleaning blood and / or an ultrafilter for purifying water, dialysis fluid, or other fluids.

[0020] Any of the operating components used in connection with a medical fluid delivery machine may be subject to the maintenance modes of this disclosure. Some of the components, such as pump actuators, valve actuators, or heaters, are constructed to last for extended periods. Other components, such as filters, are known to have relatively shorter lifespans compared to long-life components. Thus, each component of the machine may have its own maintenance service life or fall into one of different categories of service lives. To some extent, the maintenance modes of this disclosure are more applicable to components with shorter service lives and components with longer service lives that are nearing the end of their expected lifespans. However, in any case, the maintenance modes of this disclosure may be applied to any operating component of a medical fluid delivery machine. "Operating component" may mean a component of a medical fluid delivery machine or its peripheral equipment that generates data that can be tested to generate operational or test data, although it does not necessarily have to be so.

[0021] In one embodiment, the maintenance configuration involves analyzing self-test data over time to analyze the components. For example, suppose a machine provides an ultrafilter for purifying water, dialysis fluid, or other fluids. The machine may then perform a self-test on the ultrafilter before each procedure. The ultrafilter contains a thin, semi-permeable membrane whose walls have tiny pores that allow liquid to pass through and be filtered. If one of the membranes ruptures or a pore begins to open, particulate matter intended to be filtered may pass through the rupture or open pore, causing the ultrafilter to be unable to purify the liquid as well as it previously could. One self-test is then to perform a pressure decay test on the membrane prior to the procedure to determine how much the membrane leaks out.

[0022] In this form of disclosure, it is considered to set two limits with respect to pressure decay testing: a first replacement limit, when reached, that would necessitate the replacement of the ultrafilter. A second soft limit is also set, which informs the operator that this particular ultrafilter is beginning to degrade and should be monitored more closely, so that it can be replaced when its leakage rate is approaching but not reaching the replacement limit. Several advantages of a soft limit warning exist. First, the machine has enjoyed the majority, or even almost all, of the useful life of the ultrafilter. Second, the replacement is estimated to be done at a time convenient for all parties involved and is done on a "discretionary" basis, as opposed to a "mandatory" basis. The machine is only interrupted for the time required to replace the component. Patients and clinicians / physicians do not need to wait for the part to arrive in order to perform another procedure.

[0023] In another embodiment, the maintenance mode analyzes component performance data over time as an alternative to, or in addition to, self-test data. As discussed above, an exemplary self-test for a crossflow filter is a pressure decay test that seeks leaks. In addition to leaks, crossflow filters may need to be replaced when they become clogged. As mentioned above, a properly functioning crossflow filter membrane traps particulate matter and allows the purified liquid to pass through. The trapped particulate matter forms a concentrated slurry with the liquid that does not pass through the membrane. The slurry is intended to be pushed back to the inlet side of the crossflow filter or to be discharged. However, instead of proceeding with the slurry, the particulate matter may instead embed itself into the membrane wall and begin to clog the crossflow filter.

[0024] Therefore, monitoring the performance output of components such as crossflow filters is contemplated. For example, monitoring the flow rate downstream of a crossflow filter is contemplated. Exchange and soft limits are reset for flow rate monitoring. After reaching the soft limit, the output flow rate performance of the crossflow filter is closely monitored. The crossflow filter can then be replaced slightly before reaching the exchange flow rate limit, thus extending the crossflow filter life as much as possible while still maintaining a relatively high performance level.

[0025] A single component, such as a crossflow filter example, may thereby have a plurality of criteria according to which they are judged under the maintenance mode of the present disclosure. Each criterion has its own soft limit that is evaluated independently to determine when to replace the component.

[0026] The criteria may be evaluated for reasons in addition to the possible replacement of components. For example, data may be collected from multiple machines and evaluated to determine the most appropriate time to order or build new ones of the components. For example, ultrafiltration filters may be purchased from an external company or fabricated in-house. However, in either case, the components are likely to need to be produced and ordered in minimum quantities. For example, if the minimum order or production quantity for ultrafiltration filters is 100, there are only 20 ultrafiltration filters remaining in stock, and there are 30 ultrafiltration filters in the field at or below the soft limit, the system of the present disclosure may prompt the purchasing staff to place a new order for ultrafiltration filters quickly. Thus, new components are ordered so as to arrive only when needed so that there is no shortage of components.

[0027] The maintenance forms of the present disclosure may be implemented at the machine level, at the comprehensive platform system level that monitors many machines, or in a combination of the same. Continuing with the ultrafiltration filter example, in one embodiment, each machine tracks the results of pressure decay tests, downstream flow rate monitoring, replacement limits, and soft limits. When the soft limit is reached, the machine's display device may display an audio, visual, or audiovisual alert to inform the operator of the occurrence and / or provide a maintenance screen that shares the same. The alert or maintenance screen may include a graph showing the pressure decay data or downstream flow rate data on a daily basis from the day the soft limit was triggered and including data thereafter. The machine may be programmed to enter a "monitoring mode" in which the graph is updated each time new data is generated so that the user can check how the ultrafiltration filter is trending after the soft limit is reached. Perhaps the data moves around the soft limit so that the ultrafiltration filter can still be used. Or perhaps the data follows a descending line towards the replacement limit, indicating that the ultrafiltration filter needs to be replaced soon.

[0028] The machine may also use the current slope of the data line from the graph or a curve mathematically formed from multiple data points to calculate when the line would intersect the replacement limit, assuming the slope or curve does not change. Thus, along with the graph, the machine in "monitoring mode" may display the estimated number of days or actions until replacement becomes necessary. If the slope changes, the machine updates the estimate accordingly.

[0029] The “monitoring mode” output, including graphs and the number of days or procedures until replacement, may, in addition to or alternatively, be displayed on a remote computer, such as the clinician’s computer and / or the maintenance personnel’s computer. Connecting the machine to the remote clinician’s computer and / or the maintenance personnel’s computer via one or more servers is considered, as will be discussed in detail below. After each procedure, the machine sends data via one or more servers to a database accessible by the clinician’s computer and / or the maintenance personnel’s computer. “Monitoring mode” data from multiple machines may be placed in a flagged folder. Maintenance personnel may be tasked with routinely accessing the flagged folder, for example, to view “monitoring mode” data for multiple machines. Maintenance personnel can then decide whether to schedule component replacements for each “monitoring mode” scenario.

[0030] It is considered that the medical fluid delivery machine of this disclosure will be provided to multiple clinics, with each clinic under the overall system of this disclosure. Meanwhile, maintenance personnel will typically support the manufacturer of the machine. The system is customizable and will then allow each clinic to decide whether to maintain its own machine or to contract with the manufacturer's maintenance personnel to maintain the machine on its behalf. If a clinic maintains its own machine, it may decide to have the machine itself display “monitoring mode” as described herein. Alternatively, the clinic may access a flag file via a server to analyze the “monitoring mode” data. If a clinic decides to contract with the manufacturer's maintenance personnel to maintain the machine, the manufacturer's maintenance personnel will remotely monitor the flag file via a server to access the “monitoring mode” data.

[0031] Since the embodiment of the ultrafilter is a component that clearly benefits from the maintenance configuration of this disclosure, such embodiment will be used throughout this specification. Ultrafilters are known to have a limited lifespan and are relatively expensive components. Therefore, it is desirable to get as much use out of them as possible before replacement. Dialyzers and hemofilters are other good embodiments. Dialyzers and hemofilters can be sterilized and packaged as part of a complete blood set, which will need to be replaced if the dialyzer leaks or deteriorates (blockage, as in the case of an ultrafilter).

[0032] It should be understood that any component subject to leakage testing, such as pressure decay testing, may benefit from the maintenance configurations of this disclosure. For example, treatment fluid passages or blood flow passages, or parts thereof, may be pressure-checked, placed in “monitoring mode,” or replaced as necessary. Fluid valves and pumps may be pressure-checked, placed in “monitoring mode,” or replaced as necessary. Fluid pumps may also be evaluated with respect to downstream flow rate output. If the machine is pneumatically driven, its pneumatic solenoid valves may also be pressure-checked, placed in “monitoring mode,” or replaced as necessary.

[0033] It should also be understood that any sensing component whose output can be tested, for example, by exposure to a known pressure, temperature, or conductivity sample, may benefit from the maintenance configuration of this disclosure. Other suitable components are also described herein.

[0034] In light of the disclosure herein, and without limiting the disclosure in any way, unless otherwise specified, a first aspect of the disclosure, which may be combined with any other aspects enumerated herein, includes a medical fluid delivery system comprising a medical fluid delivery machine, which includes at least one component that produces associated output data; at least one component replacement limit relating to at least one component; and a computer which stores the at least one component replacement limit and is programmed to analyze the output data and provide an indication of how well the at least one component is performing with respect to its component replacement limit.

[0035] In a second aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, the medical fluid delivery machine includes a display device, a computer is provided by the control unit of the medical fluid delivery machine, and indications are displayed by the display device of the medical fluid delivery machine.

[0036] In a third aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, the computer is a remote computer having a display device, the medical fluid delivery machine communicates data with the remote computer via at least one server, and the indication is displayed by the display device of the remote computer.

[0037] In the fourth aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, the associated output data includes flux rates, and at least one of the component exchange limits is a component exchange flux rate.

[0038] Unless otherwise specified, a fifth aspect of the Disclosure, which may be combined with the fourth aspect in combination with any other aspect enumerated herein, includes at least one component: (i) a filter, the flow rate of which is the flow rate downstream of the filter; (ii) a medical fluid delivery pump, the flow rate of which is the flow rate downstream of the medical fluid delivery pump; or (iii) a disposable item, the flow rate of which is the flow rate downstream of the disposable item.

[0039] Unless otherwise specified, a sixth aspect of the Disclosure, which may be combined with any other aspects enumerated herein, includes at least one component soft limit in addition to at least one component exchange limit stored by a computer, and an indication of the degree to which at least one component is functioning well with respect to its component exchange limit includes whether the component is functioning between its soft limit and its component exchange limit.

[0040] Unless otherwise specified, a seventh aspect of this disclosure, which may be combined with the sixth aspect in combination with any other aspect enumerated herein, is a computer programmed to generate at least one component performance graph showing at least one component that functions with respect to its software limits and component replacement limits.

[0041] Unless otherwise specified, an eighth aspect of the disclosure, which may be combined with the sixth aspect in combination with any other aspect enumerated herein, is programmed to generate an estimate of when the performance of a component will reach its replacement limit when at least one component is operating between its soft limit and its component replacement limit.

[0042] In the ninth aspect of this disclosure, which may be combined with the sixth aspect in combination with any other aspect enumerated herein unless otherwise specified, the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server and includes files provided by the computer that indicate each component that functions between its software limits and its component exchange limits.

[0043] In the tenth aspect of this disclosure, which may be combined with the sixth aspect in combination with any other aspect enumerated herein unless otherwise specified, the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server and includes files provided by the computer that indicate each component of each machine that operates between its software limits and its component exchange limits.

[0044] In an eleventh aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, the computer receives output data associated with the components after each procedure has been performed by the medical fluid delivery device.

[0045] In a twelfth aspect of the Disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, a medical fluid delivery system includes a medical fluid delivery machine, which includes at least one component to be tested to produce test data; at least one component replacement limit for at least one component; and a computer which stores the at least one component replacement limit and is programmed to analyze the test data and provide an indication of how well the at least one component is testing against its component replacement limit.

[0046] Unless otherwise specified, a thirteenth aspect of this disclosure, which may be combined with any other aspects enumerated herein, includes at least one component comprising a sensor for a medical fluid delivery machine, and the test analyzes the output from the sensor.

[0047] In the 14th aspect of this disclosure, which may be combined with the 13th aspect in combination with any other aspect enumerated herein unless otherwise specified, the sensor is a pressure sensor, a conductivity sensor, or a temperature sensor.

[0048] In a 15th aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, a medical fluid delivery machine includes a pneumatic source, a pressure sensor, and the test is a pressure decay test in which at least one component is subjected to pneumatic pressure via a source sensed by the pressure sensor.

[0049] Unless otherwise specified, a 16th aspect of the Disclosure, which may be combined with the 15th aspect in combination with any other aspect enumerated herein, includes a component comprising: (i) a filter including a filtration membrane, wherein the pressure decay test tests the filtration membrane; (ii) a fluid delivery component, wherein the pressure decay test tests the fluid delivery component for leakage; (iii) a disposable component, wherein the pressure decay test tests the disposable component for leakage; or (iv) a fluid line, wherein the pressure decay test tests the fluid line for leakage.

[0050] In a 17th aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, the medical fluid delivery machine includes a display device, a computer provided by the control unit of the medical fluid delivery machine, and indications displayed by the display device of the medical fluid delivery machine.

[0051] In the 18th aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, the computer is a remote computer having a display device, the medical fluid delivery machine communicates data with the remote computer via at least one server, and the indication is displayed by the display device of the remote computer.

[0052] Unless otherwise specified, a 19th aspect of the Disclosure, which may be combined with any other aspects enumerated herein, includes at least one component soft limit in addition to at least one component replacement limit stored by a computer, and an indication of the degree to which at least one component has been well tested against its component replacement limit includes whether the component test performance is between its soft limit and its component replacement limit.

[0053] In a 20th aspect of this disclosure, which may be combined with the 19th aspect in combination with any other aspect enumerated herein unless otherwise specified, the computer is programmed to generate at least one test performance graph showing the test performance of at least one component against its soft limits and its component replacement limits.

[0054] In a 21st aspect of this disclosure, which may be combined with the 19th aspect in combination with any other aspect enumerated herein unless otherwise specified, the computer is programmed to generate an estimate of when the component test performance will reach its replacement limit when at least one component test performance is between its soft limit and its component replacement limit.

[0055] In the 22nd aspect of this disclosure, which may be combined with the 19th aspect in combination with any other aspect enumerated herein unless otherwise specified, the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server, including files provided by the computer that indicate the test performance of each component between its software limits and its component replacement limits.

[0056] In the 23rd aspect of this disclosure, which may be combined with the 19th aspect in combination with any other aspect enumerated herein unless otherwise specified, the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server, and includes files provided by the computer that indicate each component of each machine having test performance between its software limits and its component replacement limits.

[0057] In a 24th aspect of this disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, the computer receives test data associated with the components after each procedure has been performed by the medical fluid delivery device.

[0058] In a 25th aspect of the Disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, a medical fluid delivery system includes a medical fluid delivery machine having at least one component that produces associated output data and associated test data; at least one component output exchange limit for at least one component; at least one component test exchange limit for at least one component; and a computer that stores the at least one component output exchange limit and the at least one component test exchange limit, and analyzes the output data and test data to provide a first indication of the extent to which the at least one component is performing well with respect to its component output exchange limit and a second indication of the extent to which the at least one component is performing well with respect to its component test exchange limit.

[0059] In a 26th aspect of the Disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, a medical fluid delivery system includes a medical fluid delivery machine, which includes a component that produces at least one of associated output data or associated test data; at least one of (i) component output exchange limits and component output soft limits with respect to a component, or (ii) component test exchange limits or component test soft limits with respect to a component; and a computer, which stores at least one of (i) or (ii) and is programmed to analyze the output data with respect to (i) and provide a first indication of the extent to which a component is performing well with respect to the component output exchange limits and component output soft limits, and to analyze the test data with respect to (ii) and provide a second indication of the extent to which at least one component is performing well with respect to the component test exchange limits and component test soft limits.

[0060] In a 27th aspect of the present disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified, a medical fluid delivery system includes: a medical fluid delivery machine that operates with a disposable set over multiple treatments to mix at least one concentrate with water suitable for a desired medical fluid treatment for each treatment to form a medical fluid; a sensor configured to test the accuracy of the medical fluid mixed by the medical fluid delivery machine, which produces an output that enables a determination of the mixing accuracy; and a computer programmed to determine the mixing accuracy from the mixing accuracy output produced by the sensor and to determine whether the disposable set needs to be replaced.

[0061] Aspect 28 of this disclosure, which may be combined with Aspect 27 in combination with any other aspect enumerated herein unless otherwise specified, involves a computer programmed to use a rolling average to determine whether a disposable set needs to be replaced.

[0062] In Aspect 29 of the Disclosure, which may be combined with Aspect 27 in combination with any other aspects enumerated herein unless otherwise specified, the computer is a computer for a medical fluid delivery machine or a computer located remotely from a medical fluid delivery machine.

[0063] In Aspect 30 of the Disclosure, which may be combined with Aspect 27 in combination with any other aspects enumerated herein unless otherwise specified, the computer is programmed to determine whether a disposable set (i) needs to be replaced now or (ii) needs to be replaced for future treatment.

[0064] In the 31st aspect of this disclosure, any of the structures and functionalities disclosed in connection with Figure 1-8 may be combined with any of the other structures and functionalities disclosed in connection with Figure 1-8.

[0065] In light of this disclosure and the aspects described above, it is therefore advantageous to provide an improved medical fluid delivery device.

[0066] Another advantage of this disclosure is that it provides an improved maintenance configuration for medical fluid delivery devices.

[0067] A further advantage of this disclosure is the efficient replacement of medical fluid delivery machine components.

[0068] Another benefit of this disclosure is that it helps prevent interruptions caused by the need to wait for component replacements.

[0069] A further advantage of this disclosure is that it provides an efficient method for ordering and stockpiling medical fluid delivery machine components.

[0070] Another advantage of this disclosure is that it provides a system that is flexible to the maintenance needs of different medical fluid delivery machine users.

[0071] A further advantage of this disclosure is that it provides maintenance methods applicable to different types of components used in medical fluid delivery machines.

[0072] The advantages discussed herein may be found in one or more of the embodiments disclosed herein, and perhaps not in all of them. Additional features and advantages will be described herein and will become apparent from the detailed description and figures below. The present invention provides, for example, the following: (Item 1) A medical fluid delivery system, A medical fluid delivery machine comprising at least one component that produces associated output data, At least one component exchange limit relating to the at least one component, A computer and a computer are programmed to store the at least one component replacement limit, analyze the output data, and provide an indication of how well the at least one component is functioning with respect to that component replacement limit. A medical fluid delivery system equipped with the following features. (Item 2) The medical fluid delivery system according to item 1, wherein the medical fluid delivery machine includes a display device, the computer is provided by a control unit of the medical fluid delivery machine, and the indication is displayed by the display device of the medical fluid delivery machine. (Item 3) The medical fluid delivery system according to item 1, wherein the computer is a remote computer having a display device, the medical fluid delivery machine communicates data with the remote computer via at least one server, and the indication is displayed by the display device of the remote computer. (Item 4) The medical fluid delivery system according to item 1, wherein the associated output data includes a flow rate, and at least one of the component exchange limits is the component exchange flow rate. (Item 5) The medical fluid delivery system according to item 4, wherein the at least one component comprises (i) a filter, the flow rate of which is the flow rate downstream of the filter; (ii) a medical fluid delivery pump, the flow rate of which is the flow rate downstream of the medical fluid delivery pump; or (iii) a disposable item, the flow rate of which is the flow rate downstream of the disposable item. (Item 6) The medical fluid delivery system according to item 1, comprising at least one component soft limit in addition to the at least one component replacement limit stored by the computer, wherein the indication of the degree to which the at least one component is functioning well with respect to its component replacement limit includes whether the component is functioning between its soft limit and its component replacement limit. (Item 7) The medical fluid delivery system according to item 6, wherein the computer is programmed to generate a component performance graph showing the performance of at least one component with respect to its soft limits and component replacement limits. (Item 8) The medical fluid delivery system according to item 6, wherein the computer is programmed to generate an estimate of when the performance of at least one component will reach its replacement limit when that component is operating between its soft limit and its replacement limit. (Item 9) The medical fluid delivery system according to item 6, wherein the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server, and includes files provided by the computer indicating each component that functions between its software limits and its component exchange limits. (Item 10) The medical fluid delivery system according to item 6, wherein the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server, and includes files provided by the computer indicating each component of each machine that functions between its software limits and its component exchange limits. (Item 11) The medical fluid delivery system according to item 1, wherein the computer receives the output data associated with the components after each procedure has been performed by the medical fluid delivery device. (Item 12) A medical fluid delivery system, A medical fluid delivery machine comprising at least one component to be tested in order to produce test data, At least one component exchange limit relating to the at least one component, A computer and a system are programmed to store the replacement limit of at least one component, analyze the test data, and provide an indication of how well the at least one component is testing against its replacement limit. A medical fluid delivery system equipped with the following features. (Item 13) The medical fluid delivery system according to item 12, wherein the at least one component includes a sensor for the medical fluid delivery machine, and the test analyzes the output from the sensor. (Item 14) The medical fluid delivery system according to item 13, wherein the sensor is a pressure sensor, a conductivity sensor, or a temperature sensor. (Item 15) The medical fluid delivery machine comprises a pneumatic source and a pressure sensor, and the test is a pressure attenuation test in which at least one component is subjected to pneumatic pressure via the source, which is sensed by the pressure sensor, as described in item 12. (Item 16) The medical fluid delivery system according to item 15, wherein the at least one component includes (i) a filter including a filtration membrane, wherein the pressure decay test tests the filtration membrane; (ii) a fluid delivery component, wherein the pressure decay test tests the fluid delivery component for leakage; (iii) a disposable component, wherein the pressure decay test tests the disposable component for leakage; or (iv) a fluid line, wherein the pressure decay test tests the fluid line for leakage. (Item 17) The medical fluid delivery system according to item 12, wherein the medical fluid delivery machine includes a display device, the computer is provided by a control unit of the medical fluid delivery machine, and the indication is displayed by the display device of the medical fluid delivery machine. (Item 18) The medical fluid delivery system according to item 12, wherein the computer is a remote computer having a display device, the medical fluid delivery machine communicates data with the remote computer via at least one server, and the indication is displayed by the display device of the remote computer. (Item 19) A medical fluid delivery system according to item 12, comprising, in addition to the at least one component replacement limit stored by the computer, at least one component soft limit, wherein the indication of the degree to which the at least one component is well tested against its component replacement limit includes whether the component test performance is between its soft limit and its component replacement limit. (Item 20) The medical fluid delivery system according to item 19, wherein the computer is programmed to generate at least one test performance graph showing the test performance of the at least one component against its soft limit and its component replacement limit. (Item 21) The medical fluid delivery system according to item 19, wherein the computer is programmed to generate an estimate of when the test performance of at least one component will reach its replacement limit when the test performance of that component is between its soft limit and its replacement limit. (Item 22) The medical fluid delivery system according to item 19, wherein the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server, and includes files provided by the computer indicating the test performance of each component between its software limits and its component replacement limits. (Item 23) The medical fluid delivery system according to item 19, wherein the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server, and includes files provided by the computer that indicate each component of each machine having test performance between its software limits and its component replacement limits. (Item 24) The medical fluid delivery system according to item 12, wherein the computer receives the test data associated with the components after each procedure has been performed by the medical fluid delivery device. (Item 25) A medical fluid delivery system, A medical fluid delivery machine including at least one component that produces associated output data and associated test data, At least one component output exchange limit relating to the at least one component, The test replacement limit for at least one component relating to the at least one component, A computer and a computer are programmed to store the output exchange limit of at least one component and the test exchange limit of at least one component, and to analyze the output data and the test data to provide a first indication of the degree to which the at least one component is functioning well against its component output exchange limit and a second indication of the degree to which the at least one component is testing well against its component test exchange limit. A medical fluid delivery system equipped with the following features. (Item 26) A medical fluid delivery system, A medical fluid delivery machine, including a component that produces at least one of associated output data or associated test data, (i) at least one of the component output exchange limit or component output software limit for the component or (ii) component test exchange limit or component test software limit for the component, A computer and a computer programmed to store at least one of (i) or (ii), and to analyze the output data with respect to (i) and provide a first indication of the degree to which the component is functioning well against the component output exchange limit and the component output software limit, and to analyze the test data with respect to (ii) and provide a second indication of the degree to which the at least one component is testing well against the component test exchange limit and the component test software limit. A medical fluid delivery system equipped with the following features. (Item 27) A medical fluid delivery system, A medical fluid delivery machine that operates using disposable sets across multiple treatments to mix at least one concentrate with water suitable for the desired medical fluid treatment for each treatment to form a medical fluid, A sensor configured to test the accuracy of the medical fluid mixed by the medical fluid delivery machine, wherein the sensor produces a mixing accuracy output, A computer programmed to analyze the mixed accuracy output provided by the sensor and determine whether the disposable set needs to be replaced. A medical fluid delivery system equipped with the following features. (Item 28) The medical fluid delivery system according to item 28, wherein the computer is programmed to use a rolling average to determine whether the disposable set needs to be replaced. (Item 29) The medical fluid delivery system according to item 28, wherein the computer is a computer for the medical fluid delivery machine or a computer located remotely from the medical fluid delivery machine. (Item 30) The medical fluid delivery system according to item 28, wherein the computer is programmed to determine at least one of the following: (i) the disposable set needs to be replaced now, or (ii) it needs to be replaced for a future procedure. [Brief explanation of the drawing]

[0073] [Figure 1] Figure 1 is a schematic diagram of one embodiment of the medical fluid delivery machine of the present disclosure.

[0074] [Figure 2] Figure 2 is a perspective view illustrating a blood set for use in conjunction with one embodiment of the medical fluid delivery machine shown in Figure 1.

[0075] [Figure 3] Figure 3 is a schematic diagram illustrating one embodiment of a system incorporating the medical fluid delivery machine of the present disclosure so that data can be obtained from such a machine.

[0076] [Figure 4] Figure 4 is a perspective view of one embodiment of a peritoneal dialysis system, including a cyclometer and therefore a disposable set, which is implemented in the system of Figure 3 and may use any of the maintenance configuration embodiments discussed herein.

[0077] [Figure 5] Figure 5 is a plot illustrating one embodiment of the maintenance configuration of the present disclosure.

[0078] [Figure 6] Figure 6 illustrates a monitoring mode screen for a single machine, showing which of its components have output metrics equal to or below the soft limits of this disclosure.

[0079] [Figure 7] Figure 7 illustrates a flag or monitoring mode screen for multiple machines, indicating which machines have at least one component with an output metric that is at or below the soft limits of this disclosure.

[0080] [Figure 8]Figure 8 is a screenshot showing charted data for mechanical components across multiple replacement cycles. [Modes for carrying out the invention]

[0081] The embodiments described herein are applicable to any medical fluid delivery system for delivering medical fluids such as blood, dialysis fluid, replacement fluid, and / or intravenous drugs ("IV"). The embodiments are particularly well suited for the treatment of renal failure, such as all forms of hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), continuous renal replacement therapy ("CRRT"), and peritoneal dialysis ("PD"), which are collectively or generally referred to herein as the treatment of renal failure. Furthermore, the machines and maintenance configurations described herein may be used in clinical or home settings. For example, a machine operating in the maintenance configuration of this disclosure may be employed in an in-center HD machine that is started virtually continuously throughout the day. Alternatively, the maintenance configuration of this disclosure may be used in a home HD machine that can be started, for example, at night while the patient is sleeping.

[0082] Referring here to Figure 1, an embodiment of a schematic HD flow diagram relating to a medical fluid delivery system 10 operating in the maintenance configuration of this disclosure is illustrated. Because the HD system in Figure 1 is relatively complex, Figure 1 and its discussion also provide support for any of the renal failure treatment modalities and IV or drug delivery machines discussed above. Generally, a system 10 having a very simplified version of the dialysis fluid or process fluid delivery circuit is shown. The blood circuit is also simplified, but not to the same extent as the dialysis fluid circuit. The circuits have been simplified to facilitate the explanation of this disclosure, and it should be understood that the system, if implemented, would have additional structures and functionalities, such as those found in publications incorporated by reference above.

[0083] The system 10 in Figure 1 includes a blood circuit 20. The blood circuit 20 draws blood from a patient 12 and returns it to the patient. Blood is drawn from the patient 12 via an arterial line 14 and returned to the patient via a venous line 16. The arterial line 14 includes an arterial line connector 14a that connects to an arterial needle 14b, which communicates with the patient 12 for blood collection. The venous line 16 includes a venous line connector 16a that connects to a venous needle 16b, which communicates with the patient for blood return. The arterial and venous lines 14 and 16 also include line clamps 18a and 18v, which may be spring-loaded fail-safe mechanical pinch clamps. In one embodiment, the line clamps 18a and 18v automatically close in an emergency situation.

[0084] Arterial and venous lines 14 and 16 also include air or bubble detectors 22a and 22v, which may be ultrasonic air detectors, respectively. Air or bubble detectors 22a and 22v search for air in arterial and venous lines 14 and 16, respectively. If air is detected by one of the air detectors 22a and 22v, system 10 closes line clamps 18a and 18v, pauses the blood and dialysis fluid pumps, and instructs the patient to clear the air so that the procedure can be resumed.

[0085] In the illustrated embodiment, the blood pump 30 is located within the arterial line 14. In the illustrated embodiment, the blood pump 30 includes a first blood pump pod 30a and a second blood pump pod 30b. The blood pump pod 30a operates with an inlet valve 32i and an outlet valve 32o. The blood pump pod 30b operates with an inlet valve 34i and an outlet valve 34o. In one embodiment, the blood pump pods 30a and 30b are blood containers including, for example, a spherical rigid outer shell with a flexible diaphragm located within the shell, forming a diaphragm pump. One side of each diaphragm receives blood, while the other side of each diaphragm is operated by positive and negative pneumatic pressure. Alternatively, the blood pump 30 is a peristaltic pump operating with the arterial line 14.

[0086] In the illustrated embodiment, the heparin vial 24 and the heparin pump 26 are located between the blood pump 30 and the hemofilter 40 (e.g., dialyzer). The heparin pump 26 may be a pneumatic pump or a syringe pump (e.g., a stepper motor-driven syringe pump). Supplying heparin upstream of the hemofilter 40 helps prevent coagulation of the filter membrane.

[0087] A primary control processor ("ACPU") or control unit 50 includes one or more processors and memory. The control unit 50 receives air detection signals from air detectors 22a and 22v (and other sensors in system 10 such as temperature sensors, blood leak detectors, conductivity sensors, pressure sensors, and access disconnect transducers 102, 104) and controls components such as line clamps 18a and 18v, blood pump 30, heparin pump 26, and dialysis fluid pump. Blood exiting the hemofilter 40 via the venous line 16 flows through the air trap 28. The air trap 28 removes air from the blood before the dialyzed blood is returned to the patient 12 via the venous line 16.

[0088] In the hemodialysis version of system 10 in Figure 1, the dialysate or dialysate is pumped along the outside of the membrane of the hemofilter 40, while the blood is pumped through the inside of the hemofilter membrane. The dialysate or dialysate is prepared, beginning with water purification via a water purification unit 60. One preferred water purification unit is described in U.S. Patent Publication No. 2011 / 0197971, filed on April 25, 2011 (its entire contents are incorporated herein by reference and reliance upon). In one embodiment, the water purification unit includes a filter and other structures for purifying tap water (e.g., removing ions such as pathogens and chlorine) such that the water is below 0.03 endotoxin units / ml ("EU / ml") and below 0.1 colony-forming units / ml ("CFU / ml") in one implementation. The water purification unit 60 may be provided in a separate housing from the housing or chassis of the hemodialysis machine, which includes the blood circuit 20 and the dialysis fluid circuit 70.

[0089] The dialysis fluid circuit 70 is again greatly simplified in Figure 1 for the sake of illustration. The actual dialysis fluid circuit 70 may include all of the relevant structures and functions described in the publications incorporated by reference above. Some features of the dialysis fluid circuit 70 are illustrated in Figure 1. In the illustrated embodiment, the dialysis fluid circuit 70 includes a hemofilter-bound dialysis fluid pump 64. In one embodiment, the pump 64 is configured identically to the blood pump 30. The pump 64 includes a pair of pump pods 66, each having an inlet valve 68i and an outlet valve 68o, respectively, which may again be configured spherically. The two pump pods operate alternately, as in the blood pump 30, with one pump pod filling with HD dialysis fluid while the other pump pod releases the HD dialysis fluid.

[0090] Pump 64 is a hemofilter-bound dialysis fluid pump. There is another double-pod pump chamber 96 that works with valves 98i and 98o located in the discharge line 82 to push to discharge the used dialysis fluid. There is a third pod pump (not shown) for pumping purified water through the bicarbonate cartridge 72. There is a fourth pod pump (not shown) used to pump acid from the acid container 74 into the mixing line 62. The third and fourth pumps, i.e., the concentrate pumps, may be single pod pumps in one embodiment, as continuous pumping is not very important in the mixing line 62 due to a buffer dialysis fluid tank (not shown) between the mixing line 62 and the hemofilter-bound dialysis fluid pump 64.

[0091] A fifth pod pump (not shown), provided in the discharge line 82, is used to remove a known amount of ultrafiltration ("UF") when HD treatment is administered. System 10 tracks the UF pump to control and understand the amount of ultrafiltration removed from the patient. System 10 ensures that the required amount of ultrafiltration is removed from the patient by the end of the procedure.

[0092] Each of the pumps described above may, as an alternative, be a peristaltic pump operating with a pressure pipe. Where applicable, the system valve may still be pneumatically operated in accordance with the features of this disclosure.

[0093] In one embodiment, purified water from a water purification unit 60 is pumped along a mixing line 62 through a bicarbonate cartridge 72. Acid from a container 74 is pumped along the mixing line 62 into the bicarbonate water flowing from the bicarbonate cartridge 72, forming an electrolytically and physiologically compatible dialysis fluid solution. A pump and a temperature-compensated conductivity sensor used to properly mix the purified water with the bicarbonate and acid are disclosed in detail in a publication incorporated by reference above, although they are not shown.

[0094] Figure 1 also illustrates that the dialysis fluid is pumped along a fresh dialysis fluid line 76 through a heater 78 and an ultrafilter 80 before reaching the hemofilter 40, and then pumped so that the used dialysis fluid is discharged through a discharge line 82. The heater 78 heats the dialysis fluid to body temperature or about 37°C. The ultrafilter 80 further cleans and purifies the dialysis fluid before it reaches the hemofilter 40, filtering out microorganisms or contaminants introduced from the dialysis fluid, for example, through a bicarbonate cartridge 72 or an acid container 74.

[0095] The dialysis fluid circuit 70 also includes a sample port 84 in the illustrated embodiment. The dialysis fluid circuit 70 would further include a blood leak detector (not shown, but used to detect whether the fibers of the hemofilter 40 are broken) and other components (not shown) such as a balance chamber, a plurality of dialysis fluid valves, and a dialysis fluid holding tank, all of which are illustrated and described in detail in the publication, all of which are incorporated by reference above.

[0096] In the illustrated embodiment, the hemodialysis system 10 is a direct-pass system that pumps the dialysis fluid once through a hemofilter and then pumps the used dialysis fluid to discharge it. Both the blood circuit 20 and the dialysis fluid circuit 70 may be disinfected with hot water after each procedure so that the blood circuit 20 and the dialysis fluid circuit 70 can be reused. In one implementation, the blood circuit 20, including the hemofilter 40, is disinfected with hot water and reused daily for about one month, while the dialysis fluid circuit 70 is disinfected with hot water and reused for about six months.

[0097] In alternative embodiments, for example with respect to CRRT, multiple bags of sterile dialysis fluid or infusion fluid are bundled together and used sequentially. In such cases, empty supply bags can serve as discharge or used fluid bags.

[0098] The machine 90 of system 10 includes an enclosure as shown by the dashed line in Figure 1. The enclosure of machine 90 varies depending on the type of procedure, whether the procedure is performed in a center or at home, and whether the dialysis fluid / infusion supply is batch type (e.g., bagged) or direct-connected.

[0099] Figure 2 illustrates that the machine 90 of system 10 in Figure 1 may operate with a blood set 100. The blood set 100 includes an arterial line 14, a venous line 16, a heparin vial 24, a heparin pump 26 / blood pump 30, and a hemofilter 40 (e.g., a dialyzer). An air trap 28 may be located in the venous line 16 to remove air from the blood before it is returned to the patient 12. Air detectors 22a and 22v contact the arterial and venous lines 14 and 16, respectively, for operation.

[0100] In Figures 1 and 2, any of the pumps 26, 30 (30a and 30b), 64, 96 (and other pumps not shown) and any of the valves 32i, 32o, 34i, 34o, 68i, 68o, 98i, and 98o, etc., may be pneumatically actuated. In one embodiment, the pumps and valves each have a fluid side and an air side, separated by a flexible membrane. Negative pneumatic pressure may be applied to the air side of the membrane to draw fluid into the pump chamber or to open the valve (or the pump or valve may be opened by venting a positive closing pressure to the atmosphere, allowing the fluid pressure to be released). Positive pneumatic pressure may be applied to the air side of the membrane to discharge fluid from the pump chamber or to close the valve.

[0101] Referring here to Figure 3, a system 10 operating within a larger platform system 110 is illustrated. System 110 incorporates many medical fluid delivery machines 90, and therefore many associated medical fluid delivery machine systems 10. The machines 90 of the platform system 110 may be of the same type (e.g., all HD machines) or of different types (e.g., a mix of HD, PD, CRRT, and medical delivery machines).

[0102] Although a single medical fluid delivery machine 90 is illustrated as communicating with the connectivity server 118, the system 110 oversees the operation of multiple medical fluid delivery machines of the same type or different types listed above. For example, there may be M numbers of hemodialysis machines 90, N numbers of hemofiltration machines 90, O numbers of CRRT machines 90, P numbers of peritoneal dialysis machines 90, Q numbers of home drug delivery machines 90, and R numbers of home nutritional therapy machines 90 connected to the server 118 and operating with the system 110. The numbers from M to R may be the same or different, and may be zero, one, or greater than one. In Figure 3, the medical fluid delivery machine 90 is illustrated as a home therapy machine 90. However, as will be discussed below, the medical fluid delivery machine 90 does not need to be used at home (indicated by the dashed line) and may instead be used in a hospital or clinic.

[0103] The home treatment machine 90 may receive purified water at its front end from a water treatment device 60, as discussed above. In one embodiment, the water treatment device 60 connects to the home treatment machine 90 via an Ethernet® cable. In the illustrated embodiment, the home treatment machine 90 of system 110 operates with other devices besides the water treatment device 60, such as a blood pressure monitor 104, a weighing device, e.g., a wireless weighing device 106, and a user interface such as a wireless tablet user interface 122. In one embodiment, the home treatment machine 90 connects wirelessly to a server 118 via a modem 102. Each of these components may be located within the patient's home, as demarcated by the dashed lines in Figure 3 (although this is not necessary). One, more, or all of the components 60, 104, 106, and 122 may communicate with the home treatment machine 90 by wire or wireless. Wireless communication may be via Bluetooth®, WiFi™, Zigbee®, Z-Wave®, Wireless Universal Serial Bus ("USB"), infrared, or any other suitable wireless communication technology. Alternatively, one, more, or all of components 60, 104, 106, and 122 may communicate with the home therapeutic device 90 via wired communication.

[0104] The connectivity server 118 communicates with many of the home healthcare device systems 110 via the home healthcare device system hub 120. The system hub 120 enables data and information about each home healthcare machine 90 and its peripherals to flow back and forth via the connectivity server 118 between the machines 90 and other clients connected to the server 118. In the illustrated embodiment, the system hub 120 is connected to a service portal 130, an enterprise resource planning system 140, a web portal 150, a business intelligence portal 160, a HIPAA-compliant database 124, a product development team 128, and electronic medical record databases 126a-126n.

[0105] Electronic medical record ("EMR") databases 126a-126n store electronic information about patients. System hub 120 may transmit data collected from log files of machine 90 to hospital or clinic databases 126a-126n to merge or supplement the medical records of those patients. Databases 126a-126n may contain patient-specific treatment and prescription data, and therefore access to such databases may be highly restricted. Enterprise resource planning system 140 retrieves and compiles data generated via patient and clinician website access, such as complaints, billing information, and lifecycle management information. Web portal 150 enables patients and clinics 152a-152n treating patients to access a publicly available website for users of system 110. Business intelligence portal 160 collects data from system hub 120 and provides the data to marketing 162, research and development 164, and quality / pharmaceutical safety monitoring 166.

[0106] It should be understood that the systems, methods, and procedures described herein may be implemented using one or more computer programs or components. The programs of a component may be provided as a set of computer instructions on any conventional computer-readable medium, including random access memory ("RAM"), read-only memory ("ROM"), flash memory, magnetic or optical disks, optical memory, or other storage media. The instructions may be configured to be executed by a processor, which, upon execution of the set of computer instructions, performs or facilitates the performance of all or part of the disclosed methods and procedures.

[0107] In one embodiment, the home treatment machine 90 performs home treatments, such as home hemodialysis, on the patient at their home, and then reports the results of the treatment to clinicians, physicians, and nurses involved in managing the patient's health and well-being. The results of the treatment may include data from the treatment machine and data from its peripheral equipment, including a water treatment device 60. The data from the water treatment device 60 may include, for example, the total volume of water delivered, the quality of the water delivered (e.g., chlorine content), the number of times the water treatment device 60 delivered water to the treatment machine 90 at different times over a series of treatments (this data may be monitored by the device 60 or the machine 90), the average flow rate of the water delivered, any alarms or alerts the water treatment device 60 experienced over the treatments, and / or, for example, the amount of time over a series of treatments or the number of cycles performed regarding component replacement information.

[0108] In one embodiment, the home treatment machine 90 writes log files using, for example, a Linux® operating system. The log files document the data of the home treatment machine 90, including peripheral device data. The log files may include one or more of the following: Extended Markup Language ("XML"), comma-separated values ​​("CSV"), or text files. The log files are stored in the home treatment machine 90's software file server box. It is also considered that data not transmitted to the machine 90 may be stored in a peripheral device, for example, a water treatment device 60. Such data may be acquired separately via a wired or wireless connection to the peripheral device, or downloaded through other data connections or storage media. For example, a maintenance worker may access additional data via a laptop connected to the water treatment device 60 or wireless meter 106, for example, via an Ethernet® connection. Alternatively, the additional data may be read remotely from the peripheral device, and the home treatment machine 90 acts as a data transfer communication channel between the peripheral device and authorized clients of system 110.

[0109] In one embodiment, the home treatment device 90 uses connectivity services, for example, via the Internet, to transfer data between the modem 102 and the system hub 120. Here, a dedicated line may be provided at each patient's home to connect the home treatment device 90 to the connectivity server 118 via the modem 102. In one embodiment, the home treatment device 90 accesses the Internet using a separate modem 102, for example, a 3G, 4G, or 5G modem. The modem 102 is an internet service provider such as Vodafone(TM). A network service provider (ISP) may be used. In one implementation, a connectivity agent 114 developed by a connectivity service provider (e.g., the provider of the connectivity server 118) is installed on the home healthcare machine 90 and started on the machine's ACPU 50. One preferred connectivity service is provided by Axeda(TM), which provides connectivity between the medical device and the connectivity server. Provides a securely managed connection 116 to 118.

[0110] The connectivity agent 114 enables the home healthcare device 90 to connect to the connectivity server 118 and transfer data to and from the connectivity server 118. The connectivity service operating through the agent 114 and server 118 ensures that the connection with the device 90 is secure, that data passes correctly through the device 90's firewall, checks for data or system crashes, and ensures that the connectivity server 118 is communicating with the correct home healthcare device 90.

[0111] In one embodiment, the home treatment machine 90 may connect to the connectivity server 118 only when the connectivity agent 114 is turned on or activated. In one embodiment, the connectivity agent 114 is turned off while the machine 90 and its peripherals are functioning during treatment and post-treatment disinfection, which prevents the home treatment machine 90 from communicating with any entity or sending or receiving data during treatment and disinfection, or when the machine 90 is operating or started up. When the home treatment machine 90 is idle, for example, after treatment and post-treatment disinfection are completed, the ACPU 112 turns on the connectivity agent 114 in one embodiment. In another embodiment, the connectivity agent 114 is turned off only during treatment (including pre-treatment). After the procedure, the connectivity agent 114 uses the connectivity service to read log files from the home treatment machine 90 and forward the data to the connectivity server 118. The connectivity service routes the data packets to their appropriate destinations, but in one embodiment, it does not modify, access, or encrypt the data.

[0112] In the system 110 of Figure 3, connectivity services via the connectivity server 118 may communicate data to various locations via the system hub 120, such as the service portal 130, clinics or hospitals 126a-126n, and the web portal 150. The connectivity server 118 enables maintenance personnel 132a-132n and / or clinicians to track and retrieve various assets and their associated information, including machine or modem serial numbers, across the network, such as appropriate home care machines 90 and 3G, 4G, or 5G modems 102. The connectivity server 118 may also be used to receive firmware upgrades, approved by the maintenance personnel supervisor 134 and obtained remotely via the service portal 130, and provide them to authorized home care machines 90 and associated peripherals such as water treatment devices 60.

[0113] The maintenance modes described herein may be performed in multiple locations, as can be seen by viewing Figure 3. When the medical fluid delivery machine 90 is a home-care machine, the maintenance modes or this disclosure may be provided on the computer of maintenance personnel 132a-132n or on the computer of a physician or clinician 126a-126n. Patients at home are generally associated with a hospital or clinic 126a-126n. The hospital or clinic may decide to maintain its own machine, in which case the maintenance modes of this disclosure would be provided on the computer of a physician or clinician 126a-126n. Alternatively, the hospital or clinic may decide to have the machine maintained by a machine manufacturer associated with the overall system 110, in which case the maintenance modes of this disclosure would be provided on the computer of maintenance personnel 132a-132n (although still accessible on the computer of a physician or clinician 126a-126n).

[0114] In another embodiment, the medical fluid delivery machine 90 is not provided at the patient's home, but instead at a hospital or clinic 126a-126n. Here, the hospital or clinic has three options: (i) the hospital or clinic contracts with a machine manufacturer associated with the overall system 110 to maintain the machine, so that the maintenance modes of the Disclosure are provided on the computer of a maintenance person 132a-132; (ii) the hospital or clinic maintains its own machine and provides the maintenance modes of the Disclosure on the computer of a physician or clinician 126a-126n; or (iii) the hospital or clinic maintains its own machine and provides the maintenance modes of the Disclosure on the machine 90 itself. In option (iii), the machine 90 may have networking as described herein, for example, using a connectivity server 118 or a system hub 120, although it is not required to do so.

[0115] The dialyzer 40 is an embodiment of a component that is a single component when used with one hemodialysis system and a multi-treatment component when used with another hemodialysis system. With respect to systems requiring multiple uses of the dialyzer 40, the dialyzer may undergo clearance and / or integrity testing as discussed above. Similarly, Figure 4 illustrates one embodiment relating to a peritoneal dialysis system 210 which may operate to use a disposable set once or over multiple treatments. The peritoneal dialysis system 210 includes a peritoneal dialysis machine or cyclorama 212 that operates a disposable set 220. The disposable set 220 includes a disposable pressure delivery cassette 222 which may include a rigid plastic intermediate section 224 that is sealed on both sides by a flexible plastic sheet diaphragm or membrane 226. The rigid plastic intermediate section 224 defines a pump and valve chamber, a rigid fluid passage, and ports for meshing with tubing 228 and tubing 232 associated with the disposable set 220 and solution bag 230. In one embodiment, the tubing 228 extends to the patient, the drain, and the heater bag 234 of the disposable set 220.

[0116] When in use, the heater bag 234 is placed on the heating tray 214 of the cyclorama 212. When not in use, as shown in Figure 4, the user interface 216 of the cyclorama 212 is folded into the heating tray 214 and covered by the lid of the cyclorama 212. When in use, the disposable pressure cassette 222 is loaded onto the pump and valve working area 218 of the cyclorama 212. A door, including an inflatable bladder and a push plate 240, is closed and pressurized to push the disposable pressure cassette 222 to work with the pump and valve working area 218 of the cyclorama 212. In one embodiment, the fluid pump and valve of the disposable pressure cassette 222 are pneumatically actuated. Alternatively, the fluid pump and valve of the disposable pressure cassette 222 are electromechanically actuated, for example, via peristaltic pressure.

[0117] In one embodiment, the disposable set 220 is a single-use or treatment item and is discarded after single use. In another embodiment, the disposable set 220 is reused multiple times. For example, the disposable set 220 may be disinfected chemically and / or by radiation, for example, by ultraviolet light, between uses. When reused, the soft and hard limits of this disclosure may be employed. For example, the disposable pressure delivery cassette 222, tubes 228, 232, solution bag 230, and heater bag 234 may each undergo one or more common or individualized integrity tests after each treatment. The soft limit may be triggered, for example, when the measured integrity air pressure drops by a certain amount within a certain period of time. The disposable set 220 may still be reused after reaching the soft limit, but the patient or user is informed that the disposable set will need to be replaced immediately. In another embodiment, the patient or user is instructed to replace the disposable set when the soft limit is reached.

[0118] In another embodiment, pumping performance is measured before, during, and / or after a procedure. Here, the cyclor 212 may anticipate that the pump chamber or valve chamber of the disposable pumping cassette 222 should reach its stroke end position within a certain period of time. The cyclor 212 may sense the stroke end position by searching for a pressure spike that occurs when the membrane 226 strikes the pump or valve chamber wall of the rigid plastic intermediate section 224. As the membrane 226 is increasingly used across multiple procedures, it may tend to wear down, requiring a longer period of time for the membrane 226 to strike the stroke end position, as seen for the same applied operating pressure. Here, a soft limit may be set to trigger when the performance of the membrane 226 has deteriorated, for example, by only 20 percent. At such a time, the patient or user may be instructed to replace the disposable set 220, or to prepare to replace the disposable set 220 immediately. Stroke end performance measurement may be performed using positive pressure so that the membrane 226 abuts against the rigid plastic intermediate section 224, using negative pressure so that the membrane 226 abuts outward against the pump and valve interface 218, or using both.

[0119] In electromechanical embodiments, for example, when a peristaltic pump is used, the performance metric may be output pressure. A certain pressure output may be expected to be provided at a certain rotational pump speed of the peristaltic pump. If the pressure output decreases due to wear on the peristaltic pump tubing over multiple procedures, a soft limit, e.g., 20 percent pressure loss, may be triggered. At such times, the patient or user may be instructed to replace the disposable set or to prepare to replace the disposable set immediately. Peristaltic pump performance measurement may be performed using the positive pressure output of the electromechanical pump, using the negative pressure input of the electromechanical pump, or both.

[0120] In another embodiment, the ability of a valve on a disposable pressurized cassette 222 to remain closed under positive pressure may be evaluated. Here, the valve on cassette 222, when pre-filled with fluid, may be closed by pneumatic pressure, for example, under a positive pressure of 5 psig. The closed valve then receives fluid pressure from within it via the operation of a pump chamber through which the valve communicates with the fluid, starting, for example, 3 psig and increasing. The valve is expected to open when the pressurized pressure exceeds a valve holding pressure of 5 psig. When this occurs, a measurable pressure drop will occur in the pump chamber, as fluid can now proceed through the valve. However, if the measured pressure drop indicating valve opening occurs before the valve closing pressure of 5 psig is reached, this may indicate a poorly seated valve or a worn valve membrane 226. A soft limit may be triggered if the valve holding pressure decreases, for example, to 20 percent of the valve closing pressure for any reason. In such cases, the patient or user may be instructed to replace the disposable set 220, or to prepare to replace the disposable set 220 immediately.

[0121] In further embodiments, the ability of a fluid pump, which is pneumatically or electromechanically driven, to properly mix the solutions is monitored. One or more conductivity sensors may be used, for example, to verify that the cyclorama 212 (or hemodialysis machine 90) is mixing one or more concentrates in the correct proportions with purified water to suit whatever procedure is being performed. Herein, the soft and hard limit systems and methodologies of this disclosure may explore weighted trends or trends over multiple days and / or procedures to determine whether a soft limit has been reached (although it is not necessary to do so). For example, a soft limit is reached if a moving average of 3 days or a procedure trend falls below a certain accuracy percentage of the commanded conductivity, e.g., 95 percent accuracy or below. At such a time, the patient or user may be instructed to replace the disposable set or to prepare to replace the disposable set immediately. Weighted trends allow one or more mixed conductivity results below a specified accuracy level to occur without triggering a soft limit. In a 3-day average trend, for example, if the mixture conductivity accuracy is 96%, 96%, and 94% over 3 days, the average of 95.3% remains above the 95% accuracy limit so that the soft limit is not triggered. However, if the next day also produces, for example, a mixture conductivity accuracy of 94%, the current 3-day results will be 96%, 94%, and 94%, resulting in an average of 94.7%, which triggers the soft limit of this disclosure. Moving averages allow anomalies to occur in situations where anomalies typically occur, such as in mixed conditions that may not be perfectly homogeneous, so as not to overreact the mixture and thereby extend the lifespan of the disposable set.

[0122] It should be understood that each embodiment discussed in relation to the peritoneal dialysis system 210 in Figure 4 is equally applicable to any blood purification modality discussed herein, e.g., those employing the medical fluid delivery machine 90 and / or blood set 100. Figure 2 shows a pneumatically operated blood set 100, which may undergo, for example, pneumatic integrity and performance tests, pumping power tests, and / or mixing accuracy tests as just described.

[0123] Referring here to Figure 5, the illustrated maintenance configuration may be implemented in the computers of maintenance personnel 132a-132 (Figure 3), in the computers of physicians or clinicians 126a-126n (Figure 3), and / or on the machines 90 (Figure 3) and / or 212 (Figure 4) themselves. Figure 5 illustrates an embodiment of the maintenance configuration of the present disclosure. Component usage counts are provided along the x-axis, while performance metrics for components are provided along the y-axis. In the illustrated embodiment, better performance is indicated by a larger number along the y-axis, for example, by the fluid flow rate through the ultrafilter 80 (Figure 1).

[0124] As illustrated in Figure 5, in the first component replacement scenario (1), a component, for example, the ultrafilter 80, is replaced after a certain number of treatments or a certain number of usage hours. This scenario is disadvantageous because, in order to ensure that the component is not used after failure, the treatment limit or usage hour limit must be set low using a safety factor to account for variations in each component analyzed under this scenario.

[0125] As illustrated in Figure 5, in the second component replacement scenario (2), the component is replaced immediately after it fails. This scenario is also disadvantageous because the replacement is required here before another procedure can be performed, which may cause the machine to be disconnected while the new component is being installed. Furthermore, the component may fail during the procedure, potentially creating a safety issue. In addition, component failure may leave a negative impression on the patient, physician, and / or clinician regarding machine 90 or Cycle 212.

[0126] As illustrated in Figure 5, in the maintenance configuration of this disclosure, the soft limit is set at a certain safety factor that exceeds the hard limit, which represents the component failure performance along the y-axis. The soft limit as illustrated will generally allow for a greater number of actions or operating times than the maintenance time or usage-based limit. Even if components are replaced at the soft limit, there is a high probability that there will be an extension of component life and a reduction in component and maintenance costs over time compared to the maintenance limit.

[0127] However, replacing components when a soft limit is reached is not required. Instead, the soft limit notifies the relevant parties that component replacement is imminent. The soft limit is one method by this disclosure to provide an indication of the degree to which a component is performing well toward the component replacement limit.

[0128] To constitute the x-axis in Figure 5, there are at least two methods for having a unit represent (i) usage count (e.g., number of procedures) or (ii) usage time of a component (e.g., actual operating time). There are also at least two common methods for measuring performance metrics along the y-axis. In the first method, the performance metric of a mechanical component is measured by measuring the output of the component. In one embodiment, the ultrafilter 80 may be evaluated by measuring the output flow rate of the purified fluid from ultrafilter to ultrafilter at a set inlet fluid pressure. In the second method, the performance metric of a mechanical component is measured by testing the component. In one embodiment, the ultrafilter 80 may be evaluated via a pressure test, e.g., a pressure decay test. Both the output and test metrics evaluate the porous hollow fiber membrane of the ultrafilter 80. The flow metric checks whether the porous hollow fiber membrane is blocked or obstructed, while the pressure test metric checks whether the porous hollow fiber membrane is leaking, for example, whether there is a tear in one or more parts of the membrane.

[0129] Therefore, it is considered to track two or more performance metrics for the same component, e.g., the ultrafilter 80, for example, via a database or via a graph such as that in Figure 5. The algorithm is then programmed to signal when any of the performance metrics reach a separate soft limit or a separate hard limit. That is, the metric that fails or begins to fail first controls the replacement of the component.

[0130] Both performance metric analyses, namely component output and component testing, may be performed one or more times per procedure using the medical fluid delivery machine 90 or the cyclorama 212. For example, a pressure test of the ultrafilter 80 may be performed before each procedure to ensure that the ultrafilter 80 is not leaking. The output of the ultrafilter 80 is, for example, the flow rate of fresh dialysis fluid along the line 76 (Figure 1) from the ultrafilter 80 to the dialyzer 40 at a set pumping pressure provided by the fresh dialysis fluid pump 64. The average flow rate for a procedure may be determined by dividing the total amount of dialysis fluid delivered to the dialyzer 40 by the total time the dialysis fluid pump 64 is running during the procedure (e.g., total procedure time minus interruption time for alarms). Generating procedure performance metric data is important for monitoring the soft limits of this disclosure and tracking the extent to which components are performing well against the component replacement limits. Performance data per procedure may be uploaded to a desired location in the overall system 110 as discussed above, and / or maintained in machine 90 or cycler 212.

[0131] The following is a non-inclusive list of output metrics for the components from Figure 1-4 having outputs that can be monitored as performance metrics according to Figure 5, namely: (i) the ultrafilter of the water purification unit 60 having purified water flow rate output, (ii) the pump of the water purification unit 60 having purified water flow rate output, (iii) the filter prepack of the water purification unit 60 having chlorine removal capacity output, (iv) the blood pump 30 having blood flow rate output, (v) the dialyzer 40 having blood flow rate output, (vi) the fresh water and concentrate pumps (not shown in Figure 1) having fresh water and concentrate flow rate outputs, respectively, (vii) the fresh dialysate pump 66 having fresh dialysate flow rate output, (viii) the ultrafilter 80 having fresh dialysate flow rate output, (ix) the dialyzer 40 having used dialysate flow rate output, (x) the used dialysate pump 96 having used dialysate flow rate output, (xi) the ultrafiltrate pump (not shown in Figure 1) having ultrafiltrate flow rate output, and (xii) the blood set 100 and disposable set 220.

[0132] From the list above, it should be understood that certain outputs, such as the fresh dialysis fluid flow rate, are associated with multiple components, for example, the fresh dialysis fluid pump 66 and the ultrafilter 80. As will be discussed in detail below, it is considered to develop and maintain characteristic performance curves for different components of the medical fluid delivery machine 90 or cyclorama 212. Characteristic performance curves for two different components associated with the same output may differ sufficiently to indicate which component is failing in the actual performance curve. For example, the characteristic output flow rate from the ultrafilter 80 may slope over time as shown in Figure 5, while the characteristic output flow rate from the fresh dialysis fluid pump 66 may show a sharp decline in performance. If the actual degradation of the fresh dialysis fluid flow rate matches one of the characteristic degradations of the fresh dialysis fluid flow rate, the corresponding component can be assumed to be the cause. Alternatively, maintenance personnel may prepare to replace either component, for example, either the dialysis fluid pump 66 or the ultrafilter 80, as required when maintenance is performed.

[0133] The following are components from Figures 1-4 having outputs that can be tested as performance metrics according to Figure 5, namely: (i) pressure test of the ultrafilter of the water purification unit 60; (ii) test of the chlorine sensor of the water purification unit 60 using known dechlorinated water and / or water with a known amount of chlorine; (iii) test of any or all conductivity sensors in the dialysis fluid circuit 70 of Figure 1 using a zero conductivity fluid and / or a fluid with a known conductivity; (iv) test of any or all pressure sensors (e.g., pneumatic sensors) associated with the blood circuit 20 and dialysis fluid circuit 70 of Figure 1 using a test fluid (e.g., air) at a known pressure; (v) leakage test (e.g., pressure decay test) of any or all valves (e.g., pneumatic valves) associated with the blood circuit 20 and dialysis fluid circuit 70 of Figure 1; (vi) blood circuit 2 of Figure 1 (i) pressure tests (e.g., pressure decay) of any fluid line section associated with the dialysis fluid circuit 70, wherein the section includes a fluid pump chamber between fluid valves that define the section and allow the pump chamber to fluidly pressurize the line section; (vii) pressure tests (e.g., pressure decay) of the ultrafilter 80; (viii) fiber bundle tests known to those skilled in the art for evaluating the clearance capacity of the membrane of the dialyzer 40; (ix) conductivity or sodium spike tests known to those skilled in the art for evaluating the clearance capacity of the membrane of the dialyzer 40 (e.g., upstream and downstream of the dialyzer 40); (x) tests of air detectors 22a and 22v via passing liquid known to take in air through the sensors; and (xi) a non-exclusive list of tests performed on blood sets 100 and disposable sets 220.

[0134] In one embodiment, when the performance of a component reaches a soft limit as illustrated in Figure 5, the component is placed into “monitoring mode.” A component in monitoring mode can be communicated to the necessary individuals in various ways. Figure 6 illustrates a monitoring mode screen 242 that may be provided on the wireless tablet user interface 122 (Figure 3) of machine 90 (or screen 216 of cycra 212) in clinics 126a-126n, where a maintenance worker or clinician would access the information on the machine itself, rather than remotely on a computer. In one embodiment, the monitoring mode screen 242 is specific to that machine 90 or cycra 212. The monitoring mode screen 242 lists each component of machine 90 or cycra 212 whose performance data or test data has degraded to the soft limit illustrated in Figure 5. For each component, the exemplary monitoring mode screen 242 in Figure 6 provides (i) the name of the component, (ii) the location of the component in machine 90 or cycler 212 (e.g., specifying one of several identical components), (iii) the product order or replacement number, (iv) the estimated number of uses or hours before the replacement limit, (v) the estimated replacement limit date, and (vi) a link to a chart or graph of performance data or test data (e.g., also showing the estimated replacement limit date) as in Figure 5.

[0135] In the illustrated embodiment, the components are ordered by replacement urgency, with the components having the highest urgency listed at the top. Screen 242 may be provided by machine 90 (or screen 216 of cyclor 212) as a flag or alert to prompt a clinician or maintenance worker to scrutinize the soft limit data. Alternatively, screen 242 may be provided as part of a maintenance mode of machine 90 (or screen 216 of cyclor 212) that a clinician or maintenance worker is instructed to check routinely.

[0136] The estimated number of replacement limits for use or time is provided, in one embodiment, by determining the slope of a line from at least two data points, extending the line from the last data point along the x-axis of the chart at a slope determined with respect to future intervals, determining where the extended line intersects with a horizontal replacement limit line (Figure 5), and estimating from there the number of additional actions or operating hours that may be available before a component failure occurs. If the number of actions or operating hours performed each day is known, taking into account weekends, holidays, and non-business days, the estimated additional actions or operating hours can also be translated into estimated future dates for essential component replacements.

[0137] Using a linear slope across the last two data points may be found to be too reactive. Therefore, as an alternative, it is considered to mathematically fit the curve to all relevant data points. For example, as illustrated in Figure 5, the curve can be fitted to all performance metric data points that are above a predetermined percentage of the soft limit output (output 6), starting at output 8 (y-axis), occurring, for example, at 10 or 11 uses (x-axis). Once the actual output hits the soft limit output (at 19 component uses), the component is added to the monitoring mode screen 242, and the predicted number of additional component uses until failure is provided. The slope of line l1 in Figure 5 for 10-19 uses predicts approximately 27 total uses before failure. However, once listed on the monitoring list, the mathematical curve considering the performance metric outputs at 21 and 22 uses adjusts the prediction to failure (output 4) via line l2 so that the total use is 24. After 22 uses, maintenance personnel or other authorized personnel would therefore recognize that the component should be replaced promptly.

[0138] Referring here to Figure 7, an exemplary monitoring mode screen 244 is illustrated, shown on the computers of maintenance personnel 132a-132n and / or the computers of hospitals or clinics 126a-126n. Maintenance personnel 132a-132n and hospitals or clinics 126a-126n monitor multiple machines 90 or cyclers 212. The monitoring mode screen 244 accordingly lists each machine under the control of maintenance personnel 132a-132n or hospitals or clinics 126a-126n, having at least one component with performance or test data at or below the soft limit. For each listing, the exemplary monitoring mode screen 244 provides (i) location (e.g., facility, room in facility, or patient's home), (ii) machine identification / type, (iii) number of components at the soft limit for that machine, (iv) number of the shortest usage / hours to failure, and (v) date of the earliest failure. Again, the list on the monitoring mode screen 244 may be ordered by replacement urgency, with the machine 90 or cycler 212 with the component having the highest urgency listed at the top.

[0139] Figure 7 illustrates different types of machines under one clinic or hospital, e.g., hemodialysis machines ("HD"), peritoneal dialysis machines ("PD"), infusion or large-volume pumps ("LVP"), and CRRT machines. Note that, with respect to the location column, clinic locations may be listed for in-center machines 90 or cyclo212, while patient names (e.g., J. Doe, P. Shent) may be listed for home machines 90 or cyclo212.

[0140] The monitoring mode screen 244 may be provided as a prompt on the computers of clinics 126a-126n or maintenance personnel 132 as a flag or alert file. Alternatively, a clinician, maintenance personnel, or other authorized person may be assigned the task of checking the monitoring mode screen 244 on a daily basis. When a maintenance personnel, clinician, or other authorized person selects one of the machines from the machine list on the monitoring mode screen 244, a screen identical or similar to the monitoring mode screen 242 discussed above appears on the clinician computers 126a-126n or maintenance personnel computer 132 in Figure 6, showing each component of the selected machine with performance or test data at or below the software limits, including all the information provided by screen 242 discussed above. The maintenance personnel, clinician, or other authorized person proceeds accordingly.

[0141] Another feature of this disclosure is the analysis and tracking of performance or test data over multiple cycles in an attempt to observe trends in the data. For example, Figure 6 shows that a monitoring mode screen 242 for a particular machine 90 (or screen 216 of the cyclorama 212) may provide trend buttons for frequently replaced components such as an ultrafilter trend button 246, a dialyzer trend button 248, a pressure sensor trend button 250, and a pneumatic valve trend button 252. Selecting any of the trend buttons, for example, the ultrafilter trend button 246, brings to the user a dedicated trend screen, such as the ultrafilter trend screen 254 in Figure 8, which may be displayed on the machine user interface or on a tablet 122, the screen 216 of the cyclorama 212, a computer in the hospital or clinic 126, or a computer of a maintenance worker 132.

[0142] The ultrafilter trend screen 254 illustrates four different consecutive cases in which the ultrafilter 80 (Figure 1) was replaced on the same machine 90 or cycler 212, and in one embodiment, for the same patient (vertical dashed line). For the same date, the upper plot shows the flow rate output, while the lower plot shows the drive pressure. A maintenance worker, clinician, or other user viewing the ultrafilter trend screen 254 in Figure 8 can perceive (i) the average length of time the ultrafilter 80 persists with respect to a particular machine treating a particular patient, (ii) the state of the flow rate curve immediately before the replacement of the ultrafilter 80, and (iii) the state of the drive pressure curve immediately before the replacement of the ultrafilter 80. By viewing the plot on the far right of screen 254, from the dates 02 / 06 / 2016 to 02 / 18 / 2016, the user can confirm that all three indicators, namely the duration of operation, flow rate output, and required drive pressure, indicate that the current ultrafilter 80 is currently functioning well and replacement is not imminent. It should be considered that similar conclusions can be drawn by viewing the performance trends for the dialyzer via the dialyzer trend button 248, the pressure sensor via the pressure sensor trend button 250, and the pneumatic valve via the pneumatic valve trend button 252, as illustrated in Figure 6.

[0143] Figure 6 provides a trend button for a single machine 90 or cyclorama 212. If the machine 90 or cyclorama 212 is provided at home, the trend button would also be for a single patient. Thus, it is clearly considered that the system 10 and maintenance configuration of this disclosure may develop trends for a specific patient, including tracking which components a patient consumes most frequently and how often. Comparing the trends of one patient to another may reveal why a certain component wears out faster for a particular patient. Such analysis may lead to the determination that certain types of treatment or treatment prescriptions, e.g., more frequent treatments, longer treatments, higher temperature treatments, etc., lead to more frequent replacement of certain machine components.

[0144] If machine 90 or cycra 212 is provided in clinics 126a-126n, the tendency button is likely to be for multiple patients. Analyzing data on machines that treat multiple patients tends to exclude individual patients from the equation. This data is good for system 10 to compare two different types of the same machine, for example, different manufacturers or older machines versus newer machines. Such analysis may lead to the determination that a certain type or brand of machine 90 or cycra 212 is more likely to result in the more frequent replacement of certain machine components.

[0145] Figure 7 illustrates buttons that allow users to view combined data from similar machines (HD, PD, LVP, CRRT) across an entire clinic, across multiple clinics, or across a manufacturer's entire platform. The ultrafilter averaging button 256 provides, for example, averaged exchange duration, and such data can be segmented by ultrafilter brand and / or by any other desired characteristics, such as average operating pressure, dialysate temperature, etc., where differences exist. Similar information may be provided with respect to the dialyzer 40 via the dialyzer averaging button 258, and may also include an analysis in light of blood flow rate. Averaging may also be performed and displayed with respect to other desired components such as pressure sensors, pneumatic valves, and pumps and valve diaphragms.

[0146] Figure 7 also illustrates an immediate reorder button 260 that shows the user which components should be reordered promptly and why. Assume that the lead time and minimum order quantity for the ultrafilters 80 are 4 weeks and 100 units, respectively, and that 20 ultrafilters are currently in stock. Also assume that the maintenance configuration of this disclosure shows that, on average, 3 ultrafilters 80 are replaced weekly, but the current soft limit list shows that 6 ultrafilters 80 are currently at their soft limit, with 5 days or less until the estimated mandatory replacement. Estimates for the next 4 weeks (one lead time cycle) are therefore that 6 (soft limit for week 1) + 3 (average for week 2) + 3 (average for week 3) + 3 (average for week 4), or 15 ultrafilters 80, will be consumed. The maintenance mode may be programmed to alert the user via the immediate reorder button 260 whenever the 4-week (one lead time cycle) estimate indicates that there are five or fewer ultrafilters 80 remaining in stock. Pressing the immediate reorder button 260 thereby notifies the user to reorder the ultrafilters 80 and, in one embodiment, thus provides an estimate.

[0147] It should be understood that various changes and modifications to the preferred embodiments described herein will be obvious to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the subject matter and without diminishing the intended advantages. Accordingly, such changes and modifications are intended to be covered by the appended claims.

Claims

1. A medical fluid delivery system, A medical fluid delivery machine comprising a component having at least one of a filter, a medical fluid delivery pump, or a disposable item, wherein the medical fluid delivery machine is configured to generate performance data indicating the flow rate downstream from the component, The component replacement limit for the aforementioned component, Computers and Equipped with, The aforementioned computer, (a) storing the limits of the replacement of the components, (b) Adding the performance data to a component performance graph that shows the performance data and previous performance data as data points related to the component in relation to the component replacement limit, (c) Determining the slope of the line from at least the last two data points corresponding to the performance data and the previous performance data, (d) Extending the line from the last data point along the x-axis of the component performance graph with respect to future intervals at the determined slope, and determining the location where the extended line intersects the component replacement limit, (e) Determine at least one of the following: (i) the number of remaining component uses, (ii) the number of remaining procedures, or (iii) the number of operating hours. (f) Displaying information indicating at least one of (i) to (iii) in order to replace the component before reaching the component replacement limit, (g) to store information indicating the number of procedures or operating hours performed each day, (h) Convert at least one of (i) to (iii) into a predicted future date for replacement of essential components or a predicted date for failure, (i) Display the estimated future date for replacement of essential components or the estimated date for failure. A medical fluid delivery system programmed to perform this function.

2. The medical fluid delivery machine includes a display device, and the computer is provided by the control unit of the medical fluid delivery machine. The medical fluid delivery system according to claim 1, wherein the information relating to at least one of (i) to (iii) is displayed by the display device of the medical fluid delivery machine.

3. The computer is a remote computer having a display device, and the medical fluid delivery machine communicates data with the remote computer via at least one server. The medical fluid delivery system according to claim 1, wherein the information relating to at least one of (i) to (iii) is displayed by the display device of the remote computer.

4. A medical fluid delivery system, A medical fluid delivery machine comprising a component having at least one of a filter, a medical fluid delivery pump, or a disposable item, wherein the medical fluid delivery machine is configured to generate performance data indicating the flow rate downstream from the component, The component replacement limit for the aforementioned component, Computers and Equipped with, The aforementioned computer, (a) storing the limits of the replacement of the components, (b) Adding the performance data to a component performance graph that shows the performance data and previous performance data as data points related to the component in relation to the component replacement limit, (c) Determining the slope of the line from at least the last two data points corresponding to the performance data and the previous performance data, (d) Extending the line from the last data point along the x-axis of the component performance graph with respect to future intervals at the determined slope, and determining the location where the extended line intersects the component replacement limit, (e) Determine at least one of the following: (i) the number of remaining component uses, (ii) the number of remaining procedures, or (iii) the number of operating hours. (f) Displaying information indicating at least one of (i) to (iii) in order to replace the component before reaching the component replacement limit, (g) storing the software limits of the component relating to the component, wherein the software limits of the component indicate a deterioration in the operation or performance of the component, (h) The software limits of the component are included along with the performance graph of the component, (i) Perform (c) to (f) when at least the last two data points are between the component soft limit and the component exchange limit. A medical fluid delivery system programmed to perform this function.

5. The medical fluid delivery system according to claim 1, wherein the computer receives the performance data after each medical fluid treatment procedure has been performed by the medical fluid delivery machine.

6. The medical fluid delivery system according to claim 1, wherein the medical fluid delivery machine is an automated peritoneal dialysis machine, a hemodialysis machine, a plasma exchange machine, a hemofiltration machine, a hemodiafiltration machine, or a continuous renal replacement therapy machine.

7. The medical fluid delivery machine includes a second component, and the medical fluid delivery machine is configured to generate second performance data indicating a second flow rate downstream from the second component. The aforementioned computer further, The second component exchange limit relating to the second component is stored, Using the second component performance graph and the second performance data, perform (b) to (f) and A medical fluid delivery system according to claim 1, which is programmed to perform the following:

8. The medical fluid delivery system according to claim 7, wherein the computer is a remote computer, and the medical fluid delivery machine communicates data with the remote computer via at least one server and includes a file provided by the computer showing the information indicating at least one of (i) to (iii) for replacing the component and the second component before reaching their respective component replacement limits.

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