Disposable cassette conditioning system and method

Abstract

To provide a medical fluid delivery system.SOLUTION: A medical fluid delivery system 10 includes: (i) a medical fluid delivery machine 20 including a pneumatic manifold 50 having pump 27 and valve actuation areas 56 and a pumping gasket 60 overlaying the pump 27 and the valve actuation areas 56, sources 24, 26 of positive and negative pneumatic pressure, a plurality of pneumatic valves 58 located between the pneumatic sources 24, 26 and the pump 27 and the valve actuation areas 56, and a control unit 30 in operable communication with the plural pneumatic valves; and (ii) a disposable cassette 100 including a fluid pump chamber 112 that aligns with the pump actuation area 108 when the disposable cassette 100 is mated with the pneumatic manifold 50, the disposable cassette 100 including a sheeting body 104 overlaying the fluid pump chamber 112.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 693,696, entitled "DISPOSABLE CASSETTE CONDITIONING SYSTEM AND METHOD," filed July 3, 2018, which is incorporated herein by reference in its entirety.

[0002] The present invention relates generally to medical fluid systems, and more particularly to testing and setting up such systems, especially pneumatically powered peritoneal dialysis systems, such as hemodialysis or peritoneal dialysis. [Background technology]

[0003] (background) It is known to perform integrity tests in peritoneal dialysis systems prior to treatment, including "wet" and "dry" integrity tests. A "wet" integrity test attempts to verify that the multiple fluid valves in a disposable cassette do not leak, that leakage does not occur between multiple pump chambers in the cassette, that leakage does not occur across fluid paths, and that an isolation occluder, intended to stop liquid flow in fluid lines connected to the cassette in case of a system malfunction, is performing the procedure properly. In one known wet leak test, described in U.S. Pat. No. 5,350,357, a disposable cassette is loaded into a peritoneal dialysis cycler and a solution bag is connected. The test consists of the following steps:

[0004] (i) A negative pressure damping test of the fluid valve diaphragm is performed.

[0005] (ii) A positive pressure damping test of the fluid valve diaphragm is performed.

[0006] (iii) A positive pressure decay test is performed on the first pump chamber, while a negative pressure decay test is performed on the second pump chamber.

[0007] (iv) a negative pressure decay test is performed on the first pump chamber while a positive pressure decay test is performed on the second pump chamber, and then

[0008] (v) Both pump chambers are filled with a measured volume of fluid, all fluid valves are opened, the occlusions are closed, and positive pressure is applied to both pump chambers for a period of time, after which the volume of fluid in each pump chamber is again measured to determine whether any fluid has leaked across the occlusions.

[0009] As shown, after the solution bag is connected to the peritoneal dialysis system, the above test procedure is performed. If the integrity of the cassette or tubing is compromised, the sterility of the solution bag will be compromised. In such a case, both the disposable cassette and the solution bag will need to be discarded. In addition, it is possible that liquid from the solution bag may be drawn into the machine's operating system, causing it to malfunction.

[0010] The wet test is also susceptible to false triggers, particularly since the cold solution used in the wet test is expected to completely pinch all of the fluid lines, causing false disposable integrity test alarms every year, as the test fails when an occlusion does not properly crimp or seal the tubing lines. When the solution is cold, it cools the set tubing to a lower temperature than would be the case if the tubing was installed in room air only. Cooler tubing is less likely to occlude, and in some cases allows fluid to leak past the occluder, causing the test to fail. Once dialysis therapy begins, the fluid passing through the tubing is warmed to about 37° C., allowing the occluder to perform fully.

[0011] The "dry" integrity test is briefly described in U.S. Patent No. 6,302,653, the entire contents of which are incorporated herein by reference. The description is based in part on the "dry test" implemented in the Baxter HomeChoice® cycler of December 1998. The test consisted of four steps, the first of which occurred before the solution bag was connected. The next three steps required the solution bag to be connected, but did not require fluid to be drawn from the bag into the machine. The "dry" test eliminated the problem of fluid potentially leaking into the air pressure of the machine. The test did not prevent the sterility of the bag from potentially being compromised in response to leakage, and therefore did not prevent the disposable cassette from being discarded if its integrity was compromised.

[0012] One major part of the dry integrity test for the Baxter HomeChoice® cycler or Baxter Amia® cycler involves monitoring the air leak rate between the pressure feed gasket and the disposable cassette seating once the cassette is loaded into the machine or cycler. The test essentially determines whether the pressure feed gasket and cassette seating are properly mated, and can often fail, especially when (i) there is a deformation or imperfection in either the gasket or the seating or both, and / or (ii) there is a misalignment between them.

[0013] Therefore, a need exists for the pumping gasket and cassette sheeting to better seal together and help reduce the amount of dry integrity testing errors caused by a faulty interface between the sheeting of the disposable cassette and the gasket of the pneumatic pumping actuator. [Prior art documents] [Patent documents]

[0014] [Patent Document 1] U.S. Patent No. 5,350,357 [Patent Document 2] U.S. Patent No. 6,302,653 Summary of the Invention [Means for solving the problem]

[0015] (summary) The embodiments described herein disclose systems and methods for improving peritoneal dialysis ("PD") therapy. However, it should be understood that the present systems and methods are applicable to any type of medical fluid delivery machine that includes a membrane gasket in which a pneumatic actuator is mated with and sealed to a sheet of a disposable cassette. Such medical fluid delivery machines may be any of peritoneal dialysis ("PD"), plasma exchange, hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), continuous renal replacement therapy ("CRRT"), apheresis therapy, autologous blood transfusion, hemofiltration for sepsis, and extracorporeal membrane oxygenation ("ECMO") therapy. These modalities may be collectively or generally individually referred to herein as medical fluid delivery systems.

[0016] In one embodiment, the medical fluid delivery machine or PD cycler includes electrically actuated pneumatic valves under the control of a control unit having a processor and a memory, the memory storing software configured to operate the pneumatic valves to apply negative and / or positive pressure to the pumped gasket after it is mated with the sheet body of the disposable cassette. The negative and positive pressures are applied either before or after the dry integrity test in an attempt to improve the seal between the pumped gasket and the cassette sheet body. Massaging and moving the gasket and sheet together at the same time helps to squeeze or surround and out any air pockets from between the gasket and sheet body. Massaging and moving the gasket and sheet together at the same time also helps one of the gasket or sheet body conform to imperfections in the other of the gasket or sheet body. Massaging and moving the gasket and sheet also helps with inconsistencies between them. All benefits help to reduce the error rate of the subsequent dry integrity test.

[0017] In an embodiment, a pneumatic valve (i) controls fluid flow to and from the heater, (ii) controls fluid flow to the drain, (iii) controls fluid flow to and from the patient, (iv) controls air flow from the first reference chamber to the vent, (v) controls air flow between the first reference chamber and the first pump chamber, (vi) controls negative air pressure between the negative air pressure storage tank and the first pump chamber, (vii) controls positive air pressure between the positive air pressure storage tank and the first pump chamber, (viii) controls fluid flow between the first pump chamber and the heater bag or drain, (ix) controls fluid flow between the first pump chamber and the patient or supply container, (x) controls fluid flow between the second pump chamber and the patient or supply container, and (xi) controls fluid flow between the second pump chamber and the patient or supply container. (xii) controlling positive air pressure between the positive air pressure storage tank and the second pump chamber; (xiii) controlling negative air pressure between the negative air pressure storage tank and the second pump chamber; (xiv) controlling air flow between the second reference chamber and the second pump chamber; (xv) controlling air flow from the second reference chamber to the vent; (xvi) controlling fluid flow between the first supply container and the pump chamber; (xvii) controlling fluid flow between the second supply container and the pump chamber; (xviii) controlling fluid flow between the third supply container and the pump chamber; (xix) controlling fluid flow between the fourth supply container and the pump chamber; and (xx) controlling fluid flow between the fifth supply container and the pump chamber.

[0018] In one embodiment of a first step for a pumping gasket and cassette adjustment algorithm or routine stored in the software of and executed by the processor of a control unit of a medical fluid delivery machine, such as a peritoneal dialysis cycler, the control unit opens two pneumatic ventilation valves while all other 18 pneumatic valves are closed. This first step ventilates a reference chamber, a known volume chamber that is used to measure the pressure in the pump chamber and, in combination with the control unit, to determine the volume of medical fluid drawn into or expelled from the pump chamber using Boyle's Law. The pressure in the reference chamber at the end of the first step is at or close to zero psig.

[0019] In a second step of one embodiment for a pumping gasket and cassette sheeting adjustment algorithm or routine stored in software and executed by a processor of a control unit of a medical fluid delivery machine, such as a peritoneal dialysis cycler, the control unit opens all pneumatic valves except for (i) the pneumatic valves between the positive pneumatic storage tank and the first and second pump chambers, and (ii) the pneumatic valves between the first and second pump chambers and the first and second reference chambers. The two pneumatic vent valves to the reference chambers are still open so that the reference chamber pressure is still at atmospheric pressure. The pneumatic valves between the negative pneumatic storage tank and the first and second pump chambers are opened, allowing negative pressure to be applied to the pump chambers and to draw the pumping gasket and cassette sheeting together into the pump chamber halves defined by the pneumatic manifold of the machine or cycler. All of the fluid valves, in one implementation, are opened to allow air to flow into the disposable cassette, reducing or eliminating negative pressure that could potentially resist movement of the cassette sheeting from building up in the cassette. The pressure delivery gasket and cassette sheeting are thereby free to move and stretch and adjust together to help (i) eliminate small gaps or air pockets in the seal between them, for example, due to imperfections in either the gasket or the sheeting, or both, and (ii) align the cassette with the machine's pneumatic manifold.

[0020] In a third step of one embodiment for a pumping gasket and cassette sheeting adjustment algorithm or routine stored in software and executed by a processor of a control unit of a medical fluid delivery machine, such as a peritoneal dialysis cycler, the control unit closes all pneumatic valves such that the reference chamber pressure is maintained at atmospheric pressure, except for (i) the pneumatic valve between the positive air pressure storage tank and the first and second pump chambers, and (ii) the pneumatic vent valve to the reference chamber. The pneumatic valves that are open between the positive air pressure storage tank and the first and second pump chambers allow positive pressure to be applied to the pump chambers, pushing the pumping gasket and cassette sheeting together into the pump chamber halves defined by the disposable cassette. All of the fluid valves, in one implementation, are closed and positive pressure is applied to both sides of the mated gasket and cassette sheet body to (i) squeeze out any small gaps or air pockets that may reside between the pressure gasket and the cassette sheet body, and (ii) allow positive pressure to build up inside the disposable cassette to help align the cassette to the machine's pneumatic manifold.

[0021] The control unit, having a processor that runs software for the adjustment algorithm, can be programmed to repeat steps 2 and 3 one or more times in various embodiments. Also, steps 2 and 3 are described to operate the first and second pump chambers in the same manner. Alternatively or additionally, the gasket and sheet body in one pump chamber can be placed under negative pressure while the gasket and sheet body in the other pump chamber is placed under positive pressure.

[0022] In a fourth step of one embodiment for a pumping gasket and cassette seat adjustment algorithm or routine stored in software of and executed by a processor of a control unit of a medical fluid delivery machine, such as a peritoneal dialysis cycler, the control unit closes all pneumatic valves except for (i) the pneumatic valves between the first and second pump chambers and the first and second reference chambers, and (ii) the pneumatic ventilation valve to the reference chamber, so that the positive pressure built up in the third step is vented to atmosphere.

[0023] In a fifth step of one embodiment for a pumping gasket and cassette seat adjustment algorithm or routine stored in software and executed by a processor of a control unit of a medical fluid delivery machine, such as a peritoneal dialysis cycler, the control unit opens two pneumatic ventilation valves while all other eighteen pneumatic valves are closed. This valve in its static configuration is identical to the configuration of the first step.

[0024] As noted above, the positive and negative pressure adjustments of the gasket and cassette sheeting may be performed either before or after the dry integrity test. For example, in one instance, an adjustment routine is provided before the dry integrity test. Steps 1 through 5 described above are performed. Then, the dry integrity test is performed.

[0025] In another embodiment, the adjustment routine is provided after suffering a dryness integrity test failure. The control unit is programmed such that after a dryness integrity test failure, the medical fluid delivery machine, such as a peritoneal dialysis cycler, prompts the patient or caregiver to press a "resume" button, which acknowledges the dryness integrity test failure. Once "resume" is pressed, steps 1 to 5 described above are performed. The dryness integrity test is then performed again. This second embodiment may be performed in combination with or instead of the first embodiment.

[0026] The benefits of the adjustment routine are not limited to aiding in dry integrity testing. In a third embodiment, the adjustment routine is implemented as a result of a slow flow error (e.g., medical fluid is pumped too slowly to or from the patient despite attempting a higher flow rate). The control unit is programmed such that after a slow flow error, the medical fluid delivery machine, such as a peritoneal dialysis cycler, prompts the patient or caregiver to press a "resume" button that recognizes the slow flow error. Once "resume" is pressed, steps 1 to 5 described above are implemented. Treatment then resumes, hopefully with a better seal between the pumping gasket and the cassette sheet body. This third embodiment may be implemented in combination with either or both of the first and / or second embodiments.

[0027] Other tests, errors, or alarms that may be aided by the calibration routine of the present disclosure include any involving the operation of the pumping gasket and cassette seating. It should be understood that in any of the situations in which the calibration routine is performed in response to an error or alarm, no patient or caregiver action, such as pressing a "resume" button, is required. For example, if therapy is performed overnight while the patient is sleeping, it may be desirable to not wake the patient but instead automatically perform the calibration steps described above.

[0028] In a first aspect of the present disclosure, which may be combined with any other aspects enumerated herein unless otherwise specified in light of the present disclosure herein and without limiting the disclosure in any way, a medical fluid delivery system comprises a medical fluid delivery machine including a pneumatic manifold having a pump, a valve operating area, and a pumping gasket covering the pump and valve operating area, a positive pneumatic source, a negative pneumatic source, a plurality of pneumatic valves located between the positive and negative pneumatic sources and the pump and valve operating area, and a control unit in communication with the plurality of pneumatic valves, and a disposable cassette including a fluid pump chamber, where when the disposable cassette is mated with the pneumatic manifold, the fluid pump chamber aligns with the pump operating area, and the disposable cassette includes a sheet body covering the fluid pump chamber, and the control unit is configured to operate the pneumatic valve to perform an adjustment routine that moves the pumping gasket and the cassette sheet body while mated in an attempt to remove small air pockets from between the pumping gasket and the cassette sheet body.

[0029] In a second aspect of the present disclosure, which may be combined with any other aspect recited in this specification unless otherwise specified, the control unit is further configured to perform an integrity test to determine whether the pressure-feed gasket and the cassette sheet body are properly sealed together, and the adjustment routine is performed prior to the integrity test.

[0030] In a third aspect of the present disclosure, which may be combined with any other aspect recited herein unless otherwise specified, the control unit is further configured to perform an integrity test to determine whether the pressure-feed gasket and the cassette sheet body are properly sealed together, and an adjustment routine is performed after failure of the integrity test.

[0031] In a fourth aspect of the present disclosure, which may be combined with the third aspect in combination with any other aspect enumerated herein unless otherwise specified, the control unit is further configured to perform a second integrity test after the adjustment routine is performed.

[0032] In a fifth aspect of the present disclosure, which may be combined with any other aspect recited in this specification unless otherwise specified, the control unit is further configured to monitor a slow flow condition, and the adjustment routine is performed after detection of the slow flow condition.

[0033] In a sixth aspect of the present disclosure, which may be combined with any other aspect recited herein unless otherwise specified, moving the pressure-feeding gasket and cassette sheet body while engaged during the adjustment routine includes (i) applying negative air pressure to the pressure-feeding gasket and cassette sheet body while a fluid valve of the disposable cassette is open, and (ii) applying positive air pressure to the pressure-feeding gasket and cassette sheet body while a fluid valve of the disposable cassette is closed.

[0034] In a seventh aspect of the present disclosure, which may be combined with the sixth aspect in combination with any other aspect enumerated herein unless otherwise specified, the adjustment routine includes repeating (i) and (ii) at least once.

[0035] In an eighth aspect of the present disclosure, which may be combined with any other aspect recited herein unless otherwise specified, the pump actuation area and fluid pump chamber are a first chamber, the pneumatic manifold includes a second pump actuation area mating with the second fluid pump chamber, and the adjustment routine includes (i) simultaneously applying a negative air pressure to the first and second mating pump actuation and fluid pump chambers, and (ii) simultaneously applying a positive air pressure to the first and second mating pump actuation and fluid pump chambers.

[0036] In a ninth aspect of the present disclosure, which may be combined with any other aspect recited herein unless otherwise specified, the pump working area and fluid pump chamber are a first chamber, the pneumatic manifold includes a second pump working area mating with the second fluid pump chamber, and the adjustment routine includes applying a negative air pressure to the first mating pump working area and fluid pump chamber while applying a positive air pressure to the second mating pump working area and fluid pump chamber.

[0037] In a tenth aspect of the present disclosure, which may be combined with any other aspect recited herein unless otherwise specified, the pumping gasket and cassette sheet body are pre-domed toward the pump actuation area.

[0038] In an eleventh aspect of the present disclosure, which may be combined with any other aspect recited herein unless otherwise specified, a medical fluid delivery system comprises: a medical fluid delivery machine including a pneumatic manifold having a pump working area and a pumping gasket covering the pump working area; a disposable cassette including a fluid pump chamber, wherein when the disposable cassette is mated with the pneumatic manifold, the fluid pump chamber aligns with the pump working area and the disposable cassette includes a sheet body covering the fluid pump chamber; and a disposable cassette configured to perform an adjustment routine that moves the pumping gasket and the cassette sheet body while mated in two directions to remove small air pockets from between the pumping gasket and the cassette sheet body, the adjustment routine being performed (i) prior to or in response to a disposable cassette placement test, or (ii) in response to a treatment error or warning.

[0039] In a twelfth aspect of the present disclosure, which may be combined with the eleventh aspect in combination with any other aspect enumerated herein unless otherwise specified, the disposable cassette disposition test includes a dry integrity test.

[0040] In a thirteenth aspect of the present disclosure, which may be combined with the eleventh aspect in combination with any other aspect enumerated herein unless otherwise specified, the treatment error or alarm includes a slow flow error.

[0041] In a fourteenth aspect of the present disclosure, which may be combined with the eleventh aspect in combination with any other aspect recited herein unless otherwise specified, the medical fluid delivery machine is configured to perform the adjustment routine by pneumatically pulling the mated pressure-feeding gasket and cassette sheet body in a first of two directions and by pneumatically pushing the mated pressure-feeding gasket and cassette sheet body in a second of two directions.

[0042] In a fifteenth aspect of the present disclosure, which may be combined with the fourteenth aspect in combination with any other aspect recited herein unless otherwise specified, a disposable cassette is fluidly connected to a plurality of fluid lines, the fluid lines being open when the interlocking pressure-feeding gasket and cassette sheet body are pulled by air pressure and closed when the interlocking pressure-feeding gasket and cassette sheet body are pushed by air pressure.

[0043] In a sixteenth aspect of the present disclosure, which may be combined with the eleventh aspect in combination with any other aspect enumerated herein unless otherwise specified, the pressure-feed gasket includes at least one opening, the at least one opening being positioned and arranged to enable negative air pressure to be applied through the opening to draw the cassette sheet body against the pressure-feed gasket.

[0044] In a seventeenth aspect of the present disclosure, which may be combined with the eleventh aspect in combination with any other aspect enumerated herein unless otherwise specified, a medical fluid delivery machine includes a control unit, the control unit configured to cause an adjustment routine to be performed.

[0045] In an eighteenth aspect of the present disclosure, which may be combined with any other aspect recited in this specification unless otherwise specified, there is provided a method for a medical fluid delivery machine, the medical fluid delivery machine including a pressure-feed gasket that mates with a sheet body of a disposable cassette when the disposable cassette is loaded onto the medical fluid delivery machine, the method including adjusting the pressure-feed gasket and the cassette sheet body when mated by moving the pressure-feed gasket and the cassette sheet body together in an attempt to remove small air pockets from between the pressure-feed gasket and the cassette sheet body, and performing an integrity test on the adjusted pressure-feed gasket and cassette sheet body to evaluate the degree to which the cassette sheet body is sealed to the pressure-feed gasket.

[0046] In a nineteenth aspect of the present disclosure, which may be combined with the eighteenth aspect in combination with any other aspect enumerated herein unless otherwise specified, the adjusting includes alternatingly moving the interlocking pressure-feed gasket and cassette sheet body at least once.

[0047] In a twentieth aspect of the present disclosure, which may be combined with the eighteenth aspect in combination with any other aspect recited herein unless otherwise specified, the method includes readjusting the pumping gasket and cassette sheet body in response to at least one of (i) a failure of an integrity test or (ii) a slow flow error during treatment provided by the medical fluid delivery machine and disposable cassette.

[0048] In a twenty-first aspect of the present disclosure, any of the structures and functionality disclosed in connection with Figures 1-7 may be included in or combined with any of the other structures and functionality disclosed in connection with Figures 1-7.

[0049] Therefore, in light of the present disclosure and the above aspects, it is an advantage of the present disclosure to provide improved medical fluid delivery systems and methods, such as peritoneal dialysis ("PD") systems and methods.

[0050] It is another advantage of the present disclosure to provide a medical fluid delivery system and method having a pressure feed gasket and a cassette sheet adjustment routine that helps reduce or respond to dry integrity test failures.

[0051] It is a further advantage of the present disclosure to provide a medical fluid delivery system and method having a pumping gasket and cassette seat adjustment routine that helps reduce or respond to slow flow errors.

[0052] It is yet another advantage of the present disclosure to provide a medical fluid delivery system and method having a pumping gasket and cassette seat adjustment routine that is time efficient to activate.

[0053] The advantages discussed herein may be found in one or some, but perhaps not all, of the embodiments disclosed herein. Additional features and advantages will be described herein and will be apparent from the following detailed description and figures. The present invention provides, for example, the following: (Item 1) 1. A medical fluid delivery system comprising: 1. A medical fluid delivery machine comprising: a pneumatic manifold having a pump, a valve actuating area, and a pumping gasket covering the pump and the valve actuating area; a source of positive air pressure; a negative air pressure source; a plurality of pneumatic valves positioned between the positive and negative air pressure sources and the pump and valve actuation area; a control unit operatively connected to the plurality of pneumatic valves; a medical fluid delivery machine comprising: a disposable cassette including a fluid pump chamber, the fluid pump chamber being aligned with the pump actuation area when the disposable cassette is mated with the pneumatic manifold, the disposable cassette including a sheet material covering the fluid pump chamber; Equipped with The medical fluid delivery system, wherein the control unit is configured to operate the pneumatic valve to perform an adjustment routine that moves the pressure-feeding gasket and the cassette sheet body while engaged in an attempt to remove small air pockets from between the pressure-feeding gasket and the cassette sheet body. (Item 2) 2. The medical fluid delivery system of claim 1, wherein the control unit is further configured to perform an integrity test to determine whether the pressure-feed gasket and the cassette sheet body are properly sealed together, and the adjustment routine is performed prior to the integrity test. (Item 3) 2. The medical fluid delivery system of claim 1, wherein the control unit is further configured to perform an integrity test to determine whether the pressure-feed gasket and the cassette sheet body are properly sealed together, and the adjustment routine is performed after failure of the integrity test. (Item 4) 4. The medical fluid delivery system of claim 2 or 3, wherein the control unit is further configured to perform a second integrity test after the adjustment routine is performed. (Item 5) 5. The medical fluid delivery system of any of items 1-4, wherein the control unit is further configured to monitor a slow flow condition, and the adjustment routine is performed after detection of the slow flow condition. (Item 6) Moving the pressure gasket and the cassette seat assembly while engaged during the adjustment routine includes (i) applying a negative air pressure to the pressure gasket and the cassette seat assembly while a fluid valve of the disposable cassette is open, and (ii) applying a negative air pressure to the pressure gasket and the cassette seat assembly while the fluid valve of the disposable cassette is closed. and applying positive air pressure to the cassette sheet body. (Item 7) 7. The medical fluid delivery system of claim 6, wherein the adjustment routine includes repeating (i) and (ii) at least one time. (Item 8) 2. The medical fluid delivery system of claim 1, wherein the pump actuation area and the fluid pump chamber are a first chamber, the pneumatic manifold includes a second pump actuation area mating with a second fluid pump chamber, and the adjustment routine includes (i) simultaneously applying a negative air pressure to the first and second mating pump actuation and fluid pump chambers, and (ii) simultaneously applying a positive air pressure to the first and second mating pump actuation and fluid pump chambers. (Item 9) 2. The medical fluid delivery system of claim 1, wherein the pump working area and the fluid pump chamber are a first chamber, the pneumatic manifold includes a second pump working area mating with a second fluid pump chamber, and the adjustment routine includes applying a negative air pressure to the first mating pump working area and fluid pump chamber while applying a positive air pressure to the second mating pump working area and fluid pump chamber. (Item 10) 10. The medical fluid delivery system of any of claims 1-9, wherein the pumping gasket and the cassette sheet are pre-domed toward the pump actuation area. (Item 11) 1. A medical fluid delivery system comprising: a medical fluid delivery machine including a pneumatic manifold having a pumping area and a pumping gasket covering the pumping area; a disposable cassette including a fluid pump chamber, the fluid pump chamber being aligned with the pump actuation area when the disposable cassette is mated with the pneumatic manifold, the disposable cassette including a sheet material covering the fluid pump chamber; and configured to perform an adjustment routine that moves the pressure feed gasket and the cassette sheet body while interlocked in two directions to remove small air pockets from between the pressure feed gasket and the cassette sheet body. Equipped with The calibration routine is performed (i) prior to or in response to a disposable cassette placement test, or (ii) in response to a treatment error or warning. (Item 12) Item 12. The medical fluid delivery system of item 11, wherein the disposable cassette disposition test includes a dry integrity test. (Item 13) 13. The medical fluid delivery system of claim 11 or 12, wherein the treatment error or alarm comprises a slow flow error. (Item 14) 14. The medical fluid delivery system of any of items 11-13, wherein the medical fluid delivery machine is configured to perform an adjustment routine by pneumatically pulling the mated pressure-feeding gasket and cassette sheet body in a first of the two directions and by pneumatically pushing the mated pressure-feeding gasket and cassette sheet body in a second of the two directions. (Item 15) The disposable cassette is in fluid communication with a plurality of fluid lines, the fluid lines including: Item 15. The medical fluid delivery system of item 14, wherein the interlocking pressure-feed gasket and cassette sheet body are opened when pulled by air pressure, and are closed when the interlocking pressure-feed gasket and cassette sheet body are pushed by air pressure. (Item 16) 16. The medical fluid delivery system of any of items 11-15, wherein the pressure-feeding gasket includes at least one opening positioned and arranged to enable negative air pressure to be applied through the opening to draw the cassette sheet body against the pressure-feeding gasket. (Item 17) 17. A medical fluid delivery system according to any of items 11-16, wherein the medical fluid delivery machine includes a control unit, the control unit being configured to cause the adjustment routine to be performed. (Item 18) 1. A method for a medical fluid delivery machine, the medical fluid delivery machine including a pumping gasket that mates with a sheet of a disposable cassette when the disposable cassette is loaded onto the medical fluid delivery machine, the method comprising: adjusting the pressure feed gasket and the cassette sheet body once engaged by moving the pressure feed gasket and the cassette sheet body together in an attempt to remove small air pockets from between the pressure feed gasket and the cassette sheet body; performing an integrity test on the prepared pressure-feed gasket and cassette sheet body to evaluate the degree to which the cassette sheet body is sealed to the pressure-feed gasket; A method comprising: (Item 19) 20. The method of claim 18, wherein adjusting comprises alternatingly moving the mated pressure feed gasket and cassette sheet body at least once. (Item 20) 20. The method of claim 18 or 19, comprising readjusting the pumping gasket and cassette sheet body in response to at least one of (i) a failure of the integrity test, or (ii) a slow flow error during treatment provided by the medical fluid delivery machine and the disposable cassette. [Brief description of the drawings]

[0054] [Figure 1] FIG. 1 is a schematic diagram of one embodiment of a system employing the tuning routine of the present disclosure.

[0055] [Diagram 2] FIG. 2 is a schematic diagram of the first step of one embodiment of the tuning routine of the present disclosure.

[0056] [Diagram 3] FIG. 3 is a schematic diagram of a second step of one embodiment of the adjustment routine of the present disclosure.

[0057] [Figure 4] FIG. 4 is a schematic diagram of a third step of one embodiment of the adjustment routine of the present disclosure.

[0058] [Diagram 5] FIG. 5 is a schematic diagram of a fourth step of one embodiment of the adjustment routine of the present disclosure.

[0059] [Figure 6] FIG. 6 is a schematic diagram of the fifth step of one embodiment of the adjustment routine of the present disclosure.

[0060] [Figure 7] FIG. 7 is a plot of the results from the tuning routine of FIGS. 2-6 employed using the system of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0061] (Detailed Description) (System Overview) Referring now to the drawings, and in particular to FIG. 1, a medical fluid delivery system is illustrated, such as a peritoneal dialysis system 10. Although the system 10 is illustrated in the context of peritoneal dialysis ("PD"), the teachings herein are applicable to any medical fluid delivery system in which a machine operates with a disposable set including a disposable cassette, including, but not limited to, peritoneal dialysis ("PD"), plasma exchange therapy, hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), continuous renal replacement therapy ("CRRT"), apheresis therapy, autologous blood transfusion, hemofiltration for sepsis, and extracorporeal membrane oxygenation ("ECMO") treatment and medical delivery. These modalities may be collectively or generally individually referred to herein as medical fluid delivery systems.

[0062] The system 10 includes a medical fluid delivery machine 20, such as a PD cycler. One suitable cycler and disposable set for operation with the cycler is disclosed in U.S. Patent No. 9,248,225, the entire contents of which are incorporated herein by reference, describing the Baxter Amia® cycler. FIG. 1 diagrammatically illustrates one embodiment for providing pneumatic actuation to the disposable set. In particular, the medical fluid delivery machine 20 includes a housing 22 that holds a positive air pressure source 24 and a negative air pressure source 26, each of which can be charged to a desired air pressure via an air pump 27 under the control of a control unit 30. The control unit 30 includes one or more processors 32, one or more memories 34, and a video controller 36 that outputs to a video screen 42 of a user interface 40. The user interface 40 may also include a touch screen overlay (not shown) and / or one or more electromechanical switches (not shown), such as membrane switches, for inputting information into the control unit.

[0063] The positive air pressure source 24 and the negative air pressure source 26 supply positive and negative air pressure, respectively, to a pneumatic manifold 50. The pneumatic manifold 50, as illustrated in more detail in FIG. 37 of U.S. Pat. No. 9,248,225, generally includes or defines a pumping chamber or area 52 and a number of pneumatic channels, represented by channel bars 54 within the pneumatic manifold 50. The pneumatic manifold 50 may be made from a metal, e.g., aluminum, or a plastic, e.g., injection molded. The pneumatic channels 54 connect to the pumping chamber or area 52 and a number of valve channels or areas 56.

[0064] In the illustrated embodiment, a plurality of electrically actuated pneumatic valves 58 are mounted on the back or inner side of the pneumatic manifold 50. In the illustrated embodiment, a positive air pressure line 44 leads from the positive air pressure source 24 to each of the pneumatic valves 58, and a negative air pressure line 46 leads from the negative air pressure source 24 to each of the pneumatic valves. In one embodiment, each valve of the disposable cassette 100 operating with the medical fluid delivery machine 20 is open under negative pressure and closed under positive pressure, so that each corresponding pneumatic valve 58 is supplied with both positive and negative pressure. In an alternative embodiment, the valves of the disposable cassette may be biased to automatically close when depressurized and open in response to negative pressure, for example. Here, the corresponding pneumatic valve 58 would only need to be supplied with negative air pressure. The pump chamber of the disposable cassette 100 draws fluid into the cassette via negative air pressure and pushes fluid out of the cassette under positive pressure. Thus, the corresponding pneumatic valve 58 for the pump chamber has both a positive and a negative air pressure source in one embodiment.

[0065] As illustrated in FIG. 1, reference chambers 28a and 28b are provided, one for each of the two pump chambers. The reference chambers 28a and 28b are known volume chambers that are used to measure the pressure within the pump chambers and, in combination with the control unit 30, determine the volume of medical fluid drawn into or expelled from the pump chambers using Boyle's Law. In the illustrated embodiment, the positive air pressure line 44 includes a first pressure sensor 38a, the negative air pressure line 46 includes a second pressure sensor 38b, the first reference chamber 28a includes a third pressure sensor 38c, while the second reference chamber 28a includes a fourth pressure sensor 38d. The pressure sensors 38a-38d output to the control unit 30, as indicated by the short dashed lines extending therefrom. Dashed lines extending from air pump 27 , reference chambers 28 a and 28 b , control unit 30 , user interface 40 , and pneumatic valve 58 indicate electrical control and / or signal communication with control unit 30 .

[0066] A pumping gasket 60 is attached to the outside of the pneumatic manifold 50 and is shown in FIG. 1 removed from the pneumatic manifold to aid in its explanation. The pumping gasket 60 is made from a rubber, such as silicone rubber, in one embodiment. The pumping gasket 60 covers the pumping chamber or area 52 and the valve channel or area 56 of the pneumatic manifold 50 and moves in those areas according to the negative or positive air pressure applied in those areas. Negative air pressure pulls the pumping gasket in the respective areas into and toward the pneumatic manifold 50, while positive air pressure pushes the pumping gasket in the respective areas outward from the pneumatic manifold 50. The pumping gasket 60 in the illustrated embodiment includes a pre-domed pumping chamber or area 62, which helps the gasket to perform a full pump stroke without having to stretch as much as a flat pumping chamber or area. The pumping gasket 60 also includes a valve area 66 that operates with a corresponding valve channel or area 56 of the pneumatic manifold 50. The pumping gasket 60 may further include openings 68, e.g., an opening for each pump and valve area, that allow negative pressure from the manifold 50 to extend through the gasket 60 and serve to draw the sheet mass of the cassette 100 onto the pumping gasket 60.

[0067] The disposable cassette 100 in the illustrated embodiment includes a rigid molded plastic piece 102 that seals on both sides to the cassette sheet body 104 and the cassette sheet body 106. The cassette sheet body 104 and the cassette sheet body 106 may be made from a thin polymeric film such as polyvinyl chloride ("PVC"). The cassette sheet body 104 and the cassette sheet body 106 are solvent bonded, heat sealed, or ultrasonically welded to the rigid plastic piece 102. The cassette sheet body 104 in the illustrated embodiment includes a pre-domed fluid pump area 108 that mates with and matches the pre-domed pumping chamber or area 62 of the pumping gasket 60. The cassette sheet body 104 further includes a valve area 110 that mates with the valve area 66 of the pumping gasket 60. The disposable cassette rigid piece 102 defines a valve chamber, e.g., a volcano valve chamber (not shown), that operates with a valve area 110 of the cassette sheet body 104 to allow or prohibit fluid flow therethrough. The disposable cassette rigid piece 102 also defines a fluid pump chamber 112 that operates with a pre-domed fluid pump area 108 of the cassette sheet body 104 to draw fluid into or expel fluid from the disposable cassette 100. The disposable cassette 100 is fluidly connected to, e.g., attached to, fluid lines (not shown), such as heater bag lines, drain lines, patient lines, and fluid source lines.

[0068] (Adjustment routine) During a treatment in which the medical fluid delivery machine 20 pneumatically activates the disposable cassette 100, the pumping gasket 60 of the pneumatic manifold 50 is intended to be mated to and act as associated with the cassette sheet body 104 of the disposable cassette 100. Due to imperfections in either the pumping gasket 60 or the cassette sheet body 104 and / or misalignment of the disposable cassette 100 relative to the pumping gasket 60, the seal between the cassette sheet body 104 and the pumping gasket 60 may not be good enough to allow the treatment to be performed. In an embodiment, the control unit 30 evaluates the seal between the cassette sheet body 104 and the pumping gasket 60, for example, via an evaluation of the leak rate, while performing a dry integrity test. If the dry integrity test fails, the disposable cassette 100, along with the remainder of the disposable set (lines and heater bag), needs to be discarded. To reduce the failure rate of the dry integrity test due to an improper seal between the cassette sheet 104 and the pumping gasket 60, the following tuning routine has been developed.

[0069] 2-6, one embodiment of a tuning routine stored in memory 34 of control unit 30 and operated by its processor 32 is illustrated. The figure shows overlaid representations of pumping chambers or areas 52 of pneumatic manifold 50, pre-domed pumping chambers or areas 62 of pumping gasket 60, pre-domed fluid pump areas 108 of sheet body 104, and fluid pump chambers 112 of stiff piece 102. The figure also shows first reference chamber 28a, which operates in conjunction with first pump chambers 52, 62, 108, 112, and second reference chamber 28b, which operates in conjunction with second pump chambers 52, 62, 108, 112.

[0070] 2-6 also show that in one embodiment, electrically actuated pneumatic valves 58 are provided for controlling the following: (i) HV_HP for controlling fluid flow to and from the heater, (ii) HV_DP for controlling fluid flow to the drain, (iii) HV_PP for controlling fluid flow to and from the patient, (iv) V_nVnt1 for controlling air flow from the first reference chamber to the vent, (v) V_FMS1 for controlling air flow between the first reference chamber and the first pump chamber, (vi) V_FMS2 for controlling air flow between the first reference chamber and the first pump chamber, and (vi) V_FMS3 for controlling air flow between the first reference chamber and the first pump chamber. (vii) V_Neg1 for controlling the negative air pressure between the storage tank and the first pump chamber; (viii) V_Pos1 for controlling the positive air pressure between the positive air pressure storage tank and the first pump chamber; (viii) HV_C1T for controlling the fluid flow between the first pump chamber and the heater bag or drain; (ix) HV_C1B for controlling the fluid flow between the first pump chamber and the patient or supply container; (x) HV_C2B for controlling the fluid flow between the second pump chamber and the patient or supply container; (xi) HV_C2T for controlling fluid flow between the second pump chamber and the heater bag or drain; (xii) V_Pos2 for controlling a positive air pressure between the positive air pressure storage tank and the second pump chamber; (xiii) V_Neg2 for controlling a negative air pressure between the negative air pressure storage tank and the second pump chamber; (xiv) VFMS_2 for controlling air flow between the second reference chamber and the second pump chamber; (xv) V_nV for controlling air flow from the second reference chamber to the vent. nt2, (xvi) HV_BP1 for controlling fluid flow between a first supply container and the pump chamber, (xvii) HV_BP2 for controlling fluid flow between a second supply container and the pump chamber, (xviii) HV_BP3 for controlling fluid flow between a third supply container and the pump chamber, (xix) HV_BP4 for controlling fluid flow between a fourth supply container and the pump chamber, and (xx) HV_BP5 for controlling fluid flow between a fifth supply container and the pump chamber.

[0071] 2 illustrates the first step of one embodiment for a pumping gasket and cassette adjustment algorithm or routine stored in memory 34 of and executed by processor 32 of control unit 30 of a medical fluid delivery machine 20, such as a peritoneal dialysis cycler, in which control unit 30 opens two pneumatic ventilation valves V_nVnt1 and V_nVnt2 while all other 18 pneumatic valves are closed. This first step ventilates reference chambers 28a and 28b. The pressure in reference chambers 28a and 28b at the end of the first step is at or near zero psig. The first step sets all of the valves to a quiescent state and prepares machine 20 and disposable cassette 100 for adjustment.

[0072] 3 illustrates a second step of one embodiment for a pumped gasket and cassette sheet adjustment algorithm or routine, in which the control unit 30 opens all pneumatic valves 58 except for (i) pneumatic valves V_Pos1 and V_Pos2 between the positive pneumatic storage tank 24 and the first and second pump chambers 52, 62, 108, 112, and (ii) pneumatic valves V_FMS1 and V_FMS2 between the first and second pump chambers 52, 62, 108, 112 and the first and second reference chambers 28a and 28b. The two pneumatic ventilation valves V_nVnt1 and V_nVnt2 to the reference chambers 28a and 28b are still open so that the reference chamber pressure is still at atmospheric pressure. Pneumatic valves V_Neg1 and V_Neg2 between the negative air pressure storage tank 26 and the first and second pump chambers 52, 62, 108, 112 are open, allowing negative pressure to be applied to the pump chambers 52, 62, 108, 112 to pull the pumping gasket 60 and the cassette sheet body 104 together into the pump chamber halves 52 defined by the pneumatic manifold 50 of the machine or cycler 20. Fluid valves HV_BP1-HV_BP5, HV_HP, HV_DP, and HV_PP, in one implementation, are all open, allowing air to flow into the disposable cassette 100, reducing or eliminating negative pressure that could potentially resist movement of the cassette sheet body 104 from building up within the cassette 100. The pressure-feed gasket 60 and the cassette sheet body 104 thereby (i) eliminate small gaps or air pockets in the seal between the pressure-feed gasket 60 and the cassette sheet body 104 caused, for example, by imperfections in either the gasket 60 or the sheet body 104 or both, and (ii) are free to move, stretch, and adjust together to correct for misalignments between the cassette 100 and the pneumatic manifold 50.

[0073] 4 illustrates a third step of one embodiment for the pumped gasket and cassette sheet body adjustment algorithm or routine, in which the control unit 30 closes all pneumatic valves 58 except for (i) pneumatic valves V_Pos1 and V_Pos2 between the positive air pressure storage tank 24 and the first and second pump chambers 52, 62, 108, 112, and (ii) pneumatic ventilation valves V_nVnt1 and V_nVnt2 to the reference chambers 28a and 28b, such that the reference chamber pressure is maintained at atmospheric pressure. The pneumatic valves V_Pos1 and V_Pos2 open between the positive air pressure storage tank 24 and the first and second pump chambers 52, 62, 108, 112 allow positive pressure to be applied to the pump chambers, pushing the pumped gasket 60 and cassette sheet body 104 together into the pump chamber halves 112, defined by the disposable cassette 100. In one implementation, all of the fluid valves 58 are closed and positive pressure is applied to both sides of the mated gasket 60 and cassette sheet body 100 to (i) squeeze out air and force out any small gaps or air pockets that may reside between the pressure gasket and the cassette sheet body, and (ii) allow positive pressure to build up inside the disposable cassette 100 to compensate for any misalignment between the cassette 100 and the pneumatic manifold 50.

[0074] The control unit 30, having a processor 32 running software in memory 34 for the adjustment routine, may or may not be programmed to repeat steps 2 and 3 one or more times in various embodiments. Also, steps 2 and 3 are described as operating the first and second pump chambers 52, 62, 108, 112 in the same way (pulling and pushing both at the same time). Alternatively or additionally, the pumping gasket 60 and sheet body 104 in one pump chamber 52, 62, 108, 112 may be placed under negative pressure while the gasket and sheet body in the other pump chamber 52, 62, 108, 112 are placed under positive pressure.

[0075] FIG. 5 illustrates a fourth step of one embodiment for a pumped gasket and cassette sheet adjustment algorithm or routine in which the control unit 30 closes all pneumatic valves 58 except for (i) pneumatic valves V_FMS1 and V_FMS2 between the first and second pump chambers 52, 62, 108, 112 and the first and second reference chambers 28a and 28b, and (ii) pneumatic vent valves V_nVnt1 and V_nVnt2 to the reference chambers, such that the positive pressure built up in the third step is vented to atmosphere.

[0076] 6 illustrates step 4 of one embodiment for a pumped gasket and cassette seat adjustment algorithm or routine, in which the control unit 30 opens two pneumatic ventilation valves V_nVnt1 and V_nVnt2 while closing all other 18 pneumatic valves 58. This valve in the static configuration is identical to the configuration in the first step.

[0077] As noted above, the positive and negative pressure adjustments of the pressure feed gasket 60 and the cassette sheet body 100 may be performed either before or after the dry integrity test. For example, in one instance, the adjustment routine of Figures 2-6 is provided before the dry integrity test. The dry integrity test is then performed.

[0078] In a second embodiment, the adjustment routine of FIG. 2-6 is provided after suffering a dryness integrity test failure. Here, the control unit 60 is programmed such that after a dryness integrity test failure, the medical fluid delivery machine 20, such as a peritoneal dialysis cycler, prompts the patient or caregiver to press a "resume" button on the user interface 40, which acknowledges the dryness integrity test failure. Once "resume" is pressed, the control unit 30 causes the adjustment routine of FIG. 2-6, described above, to be performed. The control unit 30 then causes the dryness integrity test to be performed again. This second embodiment may be performed in combination with or instead of the first embodiment.

[0079] The benefit of the adjustment routine is not limited to being useful for dry integrity testing. In a third embodiment, the control unit 30 causes the adjustment routine of Fig. 2-6 to be implemented as a result of a slow flow error (e.g., medical fluid is pumped too slowly to or from the patient despite attempting a higher flow rate). The control unit 30 is programmed such that after a slow flow error, the medical fluid delivery machine 20, such as a peritoneal dialysis cycler, prompts the patient or caregiver to press a "resume" button on the user interface 40, which recognizes the slow flow error. Once "resume" is pressed, the routine of Fig. 2-6 is implemented. Treatment then resumes in the machine 20, hopefully with a better seal between the pumping gasket 60 and the cassette sheet body 104. This third embodiment may be implemented in combination with either or both of the first and / or second embodiments.

[0080] Other errors or alarms that may be aided by the calibration routine of the present disclosure include any involving the operation of the pumping gasket and cassette sheeting. It should be understood that in any of the situations in which the calibration routine of Figures 2-6 is performed in response to an error or alarm, no patient or caregiver action is required, such as pressing a "resume" button on the user interface 40. For example, if therapy is performed overnight while the patient is sleeping, it may be desirable to automatically perform the calibration steps of Figures 2-6 instead, rather than waking the patient.

[0081] FIG. 7 illustrates a plot of the sealing performance of the pumping gasket 60 and the cassette sheeting 104 as measured by the fluid leak rate in kilopascals ("Kpa") of the dry leak integrity test, with a leak rate above 0.15 Kpa being considered a failure. All of the "A" cassette tests were performed without any of the conditioning routines of the present disclosure. All of the "B" cassette tests were performed after the conditioning routines of FIGS. 2-6. Tests were performed using different ratings of the cassette sheeting 104, with the high risk cassettes 100 having more imperfections, the medium risk cassettes 100 having fewer imperfections, and the low risk cassettes 100 having few imperfections. As illustrated, the high risk "A" cassettes exhibited failures, while all of the high risk "B" cassettes passed. The medium and low risk "A" cassettes had no failures, however, the medium and low risk "B" cassettes, respectively, had lower leak rates overall than the "A" cassettes.

[0082] It should be understood that various changes and modifications to the present preferred embodiment described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. Accordingly, such changes and modifications are intended to be covered by the appended claims. For example, although the adjustment routines of Figures 2-6 are described as applying negative pressure before positive pressure, the reverse may alternatively be applied. Again, there may be multiple pull and pull cycles, or multiple push and pull cycles. The pump chambers 52, 62, 108, 112 may be actuated simultaneously in the same way, simultaneously in different ways, simultaneously in the same way at different times (e.g., pulling the first pump chamber, then pulling the second pump chamber, then pushing the first pump chamber, then pushing the second pump chamber), or differently at different times (e.g., pulling the first pump chamber, then pushing the second pump chamber, then pushing the first pump chamber, then pulling the second pump chamber). Also, any of the different adjustment routine actuations may be combined to form an overall adjustment routine.

Claims

1. A medical fluid delivery device, comprising: a pneumatic manifold having a pumping area and a pumping gasket covering the pumping area; a first air pressure valve located between a source of positive air pressure and the pump working area; a second pneumatic valve positioned between a source of negative air pressure and the pump working area; A user interface; a control unit in communication with the user interface, the first pneumatic valve, and the second pneumatic valve; The control unit comprises: (i) receiving an indication from the user interface that a peritoneal dialysis treatment should be performed, the indication being received after a disposable cassette is mated with the pneumatic manifold, the disposable cassette being a fluid pump chamber that mates with the pump working area when the disposable cassette is mated with the pneumatic manifold; a cassette sheet body covering the fluid pump chamber; and (ii) closing the first pneumatic valve and opening the second pneumatic valve to allow negative pressure from the negative pneumatic source to be applied to the pumping area, which causes the cassette sheet covering the fluid pump chamber to be drawn into the pumping area of ​​the pneumatic manifold; (iii) closing the second pneumatic valve and opening the first pneumatic valve to allow positive pressure from the positive pneumatic pressure source to be applied to the pump working area. which results in the pressure-feed gasket being pushed into the fluid pump chamber of the disposable cassette together with the cassette sheet covering the fluid pump chamber; The medical fluid delivery device is configured to:

2. The medical fluid delivery device of claim 1, wherein the control unit is configured to repeat (ii) and (iii) multiple times.

3. The medical fluid delivery device of claim 1, wherein (ii) and (iii) correspond to adjustment routines performed by the control unit in an attempt to remove air pockets from between the pressure gasket and the cassette sheet body or align the disposable cassette with the pneumatic manifold.

4. The medical fluid delivery device of claim 3, wherein the control unit is further configured to perform a dry integrity test to determine whether the pressure gasket and the cassette sheet body are both properly sealed, and the adjustment routine is performed prior to the dry integrity test.

5. The medical fluid delivery device of claim 3, wherein the control unit is further configured to perform a dry integrity test to determine whether the pressure gasket and the cassette sheet body are both properly sealed, and the adjustment routine is performed after failure of the dry integrity test.

6. A medical fluid delivery device as described in claim 4 or 5, wherein the control unit is configured to perform the dry integrity test by monitoring the air leakage rate between the pressure delivery gasket and the cassette sheet body covering the fluid pump chamber when the disposable cassette is engaged with the pneumatic manifold.

7. The medical fluid delivery device of claim 3, wherein the control unit is further configured to monitor a slow flow condition, and the adjustment routine is performed after detection of the slow flow condition.

8. The disposable cassette includes at least one fluid valve fluidly coupled to the fluid pump chamber; 2. The medical fluid delivery device of claim 1, wherein the control unit is configured to, during (ii), open the at least one fluid valve to allow air to flow into the disposable cassette to reduce or eliminate negative pressure build-up in the disposable cassette.

9. The disposable cassette includes at least one fluid valve fluidly coupled to the fluid pump chamber; 2. The medical fluid delivery device of claim 1, wherein the control unit is configured, during (iii), to close the at least one fluid valve to allow positive pressure to build up inside the disposable cassette, thereby applying the positive pressure to the pressure-feeding gasket and the cassette sheet covering the fluid pump chamber.

10. The medical fluid delivery device of claim 1, wherein the pressure gasket is pre-domed toward the pump operating area.

11. The medical fluid delivery device of claim 1, wherein at least one of the positive air pressure source or the negative air pressure source includes an air pressure pump.

12. The medical fluid delivery device of claim 1, wherein at least one of the first pneumatic valve or the second pneumatic valve is mounted on the inside of the pneumatic manifold opposite the pressure-delivery gasket.

13. A medical fluid delivery device comprising: a pneumatic manifold having a pumping area and a pumping gasket covering the pumping area; a first air pressure valve located between a source of positive air pressure and the pump working area; a second pneumatic valve positioned between a source of negative air pressure and the pump working area; A user interface; a control unit in communication with the user interface, the first pneumatic valve, and the second pneumatic valve; The control unit comprises: (i) receiving an indication from the user interface that a conditioning routine is to be performed on a disposable cassette, the disposable cassette comprising: a fluid pump chamber that mates with the pump working area when the disposable cassette is mated with the pneumatic manifold; a cassette sheet body covering the fluid pump chamber; and (ii) closing the first pneumatic valve and opening the second pneumatic valve to allow negative pressure from the negative pneumatic source to be applied to the pumping area, which causes the cassette sheet covering the fluid pump chamber to be drawn into the pumping area of ​​the pneumatic manifold; (iii) closing the second air pressure valve and opening the first air pressure valve to allow positive pressure from the positive air pressure source to be applied to the pumping area, which causes the pumping gasket to be pushed into the fluid pump chamber of the disposable cassette along with the cassette sheet covering the fluid pump chamber; The medical fluid delivery device is configured to:

14. The medical fluid delivery device of claim 13, wherein the control unit is configured to repeat (ii) and (iii) multiple times.

15. The medical fluid delivery device of claim 13, wherein the adjustment routine is performed by the control unit in an attempt to remove air pockets from between the pressure gasket and the cassette sheet body or to align the disposable cassette with the pneumatic manifold.

16. The medical fluid delivery device of claim 13, wherein the control unit is further configured to perform a dry integrity test to determine whether the pressure gasket and the cassette sheet body are both properly sealed, and the adjustment routine is performed prior to the dry integrity test.

17. The medical fluid delivery device of claim 13, wherein the control unit is further configured to perform a dry integrity test to determine whether the pressure gasket and the cassette sheet body are both properly sealed, and the adjustment routine is performed after failure of the dry integrity test.

18. A medical fluid delivery device as described in claim 16 or 17, wherein the control unit is configured to perform the dry integrity test by monitoring the air leakage rate between the pressure delivery gasket and the cassette sheet body covering the fluid pump chamber when the disposable cassette is engaged with the pneumatic manifold.

19. The disposable cassette includes at least one fluid valve fluidly coupled to the fluid pump chamber; 14. The medical fluid delivery device of claim 13, wherein the control unit is configured to, during (ii), open the at least one fluid valve to allow air to flow into the disposable cassette and reduce or eliminate negative pressure build-up in the disposable cassette.

20. The disposable cassette includes at least one fluid valve fluidly coupled to the fluid pump chamber; 14. The medical fluid delivery device of claim 13, wherein the control unit is configured, during (iii), to close the at least one fluid valve to allow positive pressure to build up inside the disposable cassette, thereby applying the positive pressure to the pressure-feeding gasket and the cassette sheet covering the fluid pump chamber.

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