PERITONEAL DIALYSIS PATIENT LINE WITH STERILIZING FILTER AND DRAIN BYPASS

Abstract

A medical fluid treatment system includes a source of purified water; at least one concentrate for mixing with the water from the source to form a treatment fluid; a disposable set including a pumping portion, a concentrate line in fluid communication with the concentrate source and the pumping portion, and a patient line in fluid communication with the pumping portion, the patient line including a filter having a membrane configured to filter the treatment fluid, the filter configured such that (i) fresh treatment fluid flowing from the pumping portion towards a patient flows through the membrane and (ii) used treatment fluid flowing through the filter from the patient to the pumping portion bypasses the membrane; and a medical fluid delivery machine including a pump actuator operable with the pumping portion of the disposable set.

Claims

1. A peritoneal dialysis system comprising: a cycler configured to pump peritoneal dialysis fluid; and a disposable set configured to receive peritoneal dialysis fluid pumped by the cycler, the disposable set including a filter having a membrane configured to filter the peritoneal dialysis fluid, the filter configured such that (i) fresh peritoneal dialysis fluid flowing from the cycler towards a patient flows through the membrane via a pathway having an exit end located downstream from fresh peritoneal dialysis fluid flow through the membrane, and (ii) used peritoneal dialysis fluid flowing through the filter from the patient to the cycler bypasses the membrane.

2. The peritoneal dialysis system of claim 1, wherein the disposable set includes a line extending from the filter to a connector configured to connect to a patient transfer set.

3. The peritoneal dialysis system of claim 1, wherein the disposable set further includes a disposable drain line.

4. The peritoneal dialysis system of claim 1, wherein the filter is connected to a patient line extending from the cycler.

5. The peritoneal dialysis system of claim 1, wherein the pathway is a fresh peritoneal dialysis fluid pathway, and wherein the filter further includes a used peritoneal dialysis fluid pathway placed in parallel with the fresh peritoneal dialysis fluid pathway, the membrane located along the fresh peritoneal dialysis fluid pathway, the used peritoneal dialysis fluid pathway configured to enable used peritoneal dialysis fluid flowing through the filter to bypass the membrane.

6. The peritoneal dialysis system of claim 5, wherein a one-way valve is located at or near the exit end of the fresh peritoneal dialysis fluid pathway, the one-way valve positioned and arranged to prevent used peritoneal dialysis fluid returning from the patient from reaching the membrane.

7. The peritoneal dialysis system of claim 5, wherein a one-way valve is located at an exit end of the used peritoneal dialysis fluid pathway, the one-way valve positioned and arranged to prevent fresh peritoneal dialysis fluid from flowing through the filter via the used peritoneal dialysis fluid pathway.

8. The peritoneal dialysis system of claim 5, wherein the membrane is housed in a membrane housing located along the fresh fluid pathway, and wherein the filter is configured such that fresh peritoneal dialysis fluid flows from outside the membrane housing, through the membrane, and into an interior region of the membrane housing.

9. The peritoneal dialysis system of claim 5, wherein the filter includes a housing having a first port and a second port, the first port opening to a first end of the filter housing and the second port opening to a second end of the filter housing, the first end of the filter housing forming a first end of the fresh and used peritoneal dialysis fluid pathways, and the second end of the filter housing forming a second end of the fresh and used peritoneal dialysis fluid pathways.

10. The peritoneal dialysis system of claim 9, wherein the first end of the fresh fluid treatment pathway at the first end of the filter housing includes a first one-way valve, and wherein the second end of the used fluid treatment pathway at the second end of the filter housing includes a second one-way valve.

11. The peritoneal dialysis system of claim 1, wherein the membrane is housed in a membrane housing, and wherein fresh peritoneal dialysis fluid entering the filter flows to an outside of the membrane housing, and fresh, filtered peritoneal dialysis fluid exiting the filter flows from an inside of the membrane housing.

12. The peritoneal dialysis system of claim 1, wherein the membrane is a first membrane, wherein the filter includes a second membrane, wherein the first and second membranes are housed in a membrane housing, and wherein fresh peritoneal dialysis fluid entering the filter is split into a first branch flowing to an outside of the first membrane and a second branch flowing to an outside of the second membrane.

13. The peritoneal dialysis system of claim 12, wherein the membrane housing includes a grid of passageways located between the first and second membranes.

14. The peritoneal dialysis system of claim 12, wherein the first and second membranes are located on opposing sides of the membrane housing, respectively, the first branch extending to a first side of the housing and the second branch extending to a second side of the housing.

15. The peritoneal dialysis system of claim 1, which includes at least one hydrophobic vent for removing air from the filter.

16. A peritoneal dialysis system comprising: a cycler configured to pump peritoneal dialysis fluid; and a disposable set configured to receive peritoneal dialysis fluid pumped by the cycler, the disposable set including a filter in which peritoneal dialysis fluid is intended to flow in first and second directions, wherein the filter is configured to filter peritoneal dialysis fluid flowing in the first direction and to not filter peritoneal dialysis fluid flowing in the second direction, the filter including a filter housing, a first fluid pathway provided by the filter housing for flowing peritoneal dialysis fluid in the first direction, a second fluid pathway provided by the filter housing for flowing peritoneal dialysis fluid in the second direction, and a membrane positioned to filter peritoneal dialysis fluid flowing in the first direction, and wherein an exit end of the first fluid pathway is located downstream from peritoneal dialysis fluid flow through the membrane.

17. The peritoneal dialysis system of claim 16, wherein the membrane is housed in a membrane housing located within the filter housing and along the fresh fluid pathway, and wherein the filter is configured such that fresh peritoneal dialysis fluid flows from outside the membrane housing, through the membrane, and into an interior region of the membrane housing.

18. The peritoneal dialysis system of claim 16, wherein the filter housing includes a first port and a second port, the first port opening to a first end of the filter housing and the second port opening to a second end of the filter housing, the first end of the filter housing forming a first end of the fresh and used peritoneal dialysis fluid pathways, and the second end of the filter housing forming a second end of the fresh and used peritoneal dialysis fluid pathways.

19. The peritoneal dialysis system of claim 16, wherein the membrane is housed in a membrane housing located within the filter housing, and wherein fresh peritoneal dialysis fluid entering the filter flows to an outside of the membrane housing, and fresh, filtered peritoneal dialysis fluid exiting the filter flows from an inside of the membrane housing.

20. The peritoneal dialysis system of claim 16, wherein the membrane is a first membrane, and wherein the filter includes a second membrane, wherein the first and second membranes are housed in a membrane housing located within the filter housing, and wherein fresh peritoneal dialysis fluid entering the filter is split into a first branch flowing to an outside of the first membrane and a second branch flowing to an outside of the second membrane.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0072] FIG. 1 is a front elevation view of one embodiment of a medical fluid delivery system having point of use dialysis fluid production of the present disclosure.

[0073] FIG. 2 is an elevation view of one embodiment of a disposable set used with the system illustrated in FIG. 1.

[0074] FIG. 3 is an elevation section view of one embodiment of a patient line filter useable with the disposable set of FIG. 2.

[0075] FIG. 4 is a perspective section view of one embodiment of a patient line filter useable with the disposable set of FIG. 2.

[0076] FIG. 5 is a perspective section view of one embodiment of a patient line filter useable with the disposable set of FIG. 2, in which the filter housing has been removed to better show an embodiment of the filter membranes.

[0077] FIG. 6 is a perspective section view of one embodiment of a patient line filter useable with the disposable set of FIG. 2, in which the filter housing and filter membranes have been removed to better show an embodiment of the a spacer grid located between the filter membranes.

DETAILED DESCRIPTION

System Overview

[0078] The examples described herein are applicable to any medical fluid therapy system that delivers a medical fluid that may be mixed at the point of use, prior to and/or during treatment, such as dialysis fluid, substitution fluid, or an intravenous drug. The examples are particularly well suited for kidney failure therapies, such as all forms of peritoneal dialysis (“PD”), hemodialysis (“HD”), hemofiltration (“HF”), hemodiafiltration (“HDF”) and continuous renal replacement therapies (“CRRT”), referred to herein collectively or generally individually as renal failure therapy. Moreover, the machines described herein may be used in clinical or home settings. For example, the machines and associated methods may be employed in an in-center PD or HD machine, which runs virtually continuously throughout the day. Alternatively, the machine and methods may be used in a home PD or HD machine, which can for example be run at night while the patient is sleeping. The machines and methods discussed herein are also applicable to medical delivery applications. The following examples will be described in the setting of a peritoneal dialysis system having point of use dialysis fluid production but may instead be used to make point of use treatment fluid for any of the above modalities.

[0079] Referring now to the drawings and in particular to FIG. 1, one embodiment of a peritoneal dialysis system having point of use dialysis fluid production of the present disclosure is illustrated by system 10. System 10 includes a cycler 20 and a water purifier 210. Suitable cyclers for cycler 20 include, e.g., the Amia® or HomeChoice® cycler marketed by Baxter International Inc., with the understanding that those cyclers are provided with updated programming to perform and use the point of use dialysis fluid produced according to system 10. To this end, cycler 20 includes a control unit 22 having at least one processor and at least one memory. Control unit 22 further includes a wired or wireless transceiver for sending information to and receiving information from a water purifier 210. Water purifier 210 also includes a control unit 212 having at least one processor and at least one memory. Control unit 212 further incudes a wired or wireless transceiver for sending information to and receiving information from control unit 22 of cycler 20. Wired communication may be via Ethernet connection, for example. Wireless communication may be performed via any of Bluetooth™. WiFi™. Zigbee®. Z-Wave®, wireless Universal Serial Bus (“USB”), or infrared protocols, or via any other suitable wireless communication technology.

[0080] Cycler 20 includes a housing 24, which holds equipment programmed via control unit 22 to prepare fresh dialysis solution at the point of use, pump the freshly prepared dialysis fluid to patient P, allow the dialysis fluid to dwell within patient P, then pump used dialysis fluid to a drain. In the illustrated embodiment, water purifier 210 includes a drain line 214 leading to a drain 216, which can be a house drain or a drain container. The equipment programmed via control unit 22 to prepare fresh dialysis solution at the point of use in an embodiment includes equipment for a pneumatic pumping system, including but not limited to (i) one or more positive pressure reservoir, (ii) one or more negative pressure reservoir, (iii) a compressor and a vacuum pump each under control of control unit 22, or a single pump creating both positive and negative pressure under control of control unit 22, to provide positive and negative pressure to be stored at the one or more positive and negative pressure reservoirs, (iv) plural pneumatic valve chambers for delivering positive and negative pressure to plural fluid valve chambers, (v) plural pneumatic pump chambers for delivering positive and negative pressure to plural fluid pump chambers, (vi) plural electrically actuated on/off pneumatic solenoid valves under control of control unit 22 located between the plural pneumatic valve chambers and the plural fluid valve chambers, (vii) plural electrically actuated variable orifice pneumatic valves under control of control unit 22 located between the plural pneumatic pump chambers and the plural fluid pump chambers, (viii) a heater under control of control unit 22 for heating the dialysis fluid as it is being mixed in one embodiment, and (ix) an occluder 26 under control of control unit 22 for closing the patient and drain lines in alarm and other situations.

[0081] In one embodiment, the plural pneumatic valve chambers and the plural pneumatic pump chambers are located on a front face or surface of housing 24 of cycler 20. The heater is located inside housing 24 and in an embodiment includes heating coils that contact a heating pan or tray, which is located at the top of housing 24, beneath a heating lid (not seen in FIG. 1).

[0082] Cycler 20 in the illustrated embodiment includes a user interface 30. Control unit 22 in an embodiment includes a video controller, which may have its own processing and memory for interacting with primary control processing and memory of control unit 22. User interface 30 includes a video monitor 32, which may operate with a touch screen overlay placed onto video monitor 32 for inputting commands via user interface 30 into control unit 22. User interface 30 may also include one or more electromechanical input device, such as a membrane switch or other button. Control unit 22 may further include an audio controller for playing sound files, such as voice activation commands, at one or more speaker 34.

[0083] Water purifier 210 in the illustrated embodiment also includes a user interface 220. Control unit 212 of water purifier 210 in an embodiment includes a video controller, which may have its own processing and memory for interacting with primary control processing and memory of control unit 212. User interface 220 includes a video monitor 222, which may likewise operate with a touch screen overlay placed onto video monitor 222 for inputting commands into control unit 212. User interface 220 may also include one or more electromechanical input device, such as a membrane switch or other button. Control unit 212 may further include an audio controller for playing sound files, such as alarm or alert sounds, at one or more speaker 224 of water purifier 210.

[0084] Referring additionally to FIG. 2, one embodiment of disposable set 40 is illustrated. Disposable set 40 is also illustrated in FIG. 1, mated to cycler 20 to move fluid within the disposable set 40, e.g., to mix dialysis fluid as discussed herein. Disposable set 40 in the illustrated embodiment includes a disposable cassette 42, which may include a planar rigid plastic piece covered on one or both sides by a flexible membrane. The membrane pressed against housing 24 of cycler 20 forms a pumping and valving membrane. FIG. 2 illustrates that disposable cassette 42 includes fluid pump chambers 44 that operate with the pneumatic pump chambers located at housing 24 of cycler 20 and fluid valve chambers 46 that operate with the pneumatic valve chambers located at housing 24 of cycler 20.

[0085] FIGS. 1 and 2 illustrate that disposable set 40 includes a patient line 50 that extends from a patient line port of cassette 42 and terminates at a patient line connector 52. FIG. 1 illustrates that patient line connector 52 connects to a patient transfer set 54, which in turn connects to an indwelling catheter located in the peritoneal cavity of patient P. Patient line 50 also includes a sterile sterilizing grade filter 100 discussed in detail below. Disposable set 40 includes a drain line 56 that extends from a drain line port of cassette 42 and terminates at a drain line connector 58. FIG. 1 illustrates that drain line connector 58 connects removeably to a drain connector 218 of water purifier 210.

[0086] FIGS. 1 and 2 further illustrate that disposable set 40 includes a heater/mixing line 60 that extends from a heater/mixing line port of cassette 42 and terminates at a heater/mixing bag 62 discussed in more detail below. Disposable set 40 includes an upstream water line segment 64a that extends to a water inlet 66a of water accumulator 66. A downstream water line segment 64b extends from a water outlet 66b of water accumulator 66 to cassette 42. In the illustrated embodiment, upstream water line segment 64a begins at a water line connector 68 and is located upstream from water accumulator 66. FIG. 1 illustrates that water line connector 68 is removeably connected to a water outlet connector 228 of water purifier 210.

[0087] Water purifier 210 outputs water and possibly water suitable for peritoneal dialysis (“WFPD”). Sterile sterilizing grade filter 100 in patient line 50 ensures that any contaminants in the water exiting water purifier 210 are removed. In addition to sterile patient line sterilizing grade filter 100, system 10 may, but does not have to, provide one or more sterile sterilizing grade filter in one or more of the water lines. In the illustrated embodiment, a sterile sterilizing grade filter 90a is placed upstream from a downstream sterile sterilizing grade filter 90b, respectively. Filters 90a and 90b may be placed in water line segment 64a upstream of water accumulator 66. Sterile sterilizing grade filters 100, 90a and 90b may be pass-through filters that do not have a reject line. Pore sizes for the filtering membranes of filters 100, 90a and 90b may, for example, be less than a micron, such as 0.1 or 0.2 micron. Suitable sterile sterilizing grade filters 100, 90a and 90b may be provided by the assignee of the present disclosure. In an embodiment, only one of upstream or downstream sterilizing filter 90a and 90b is needed to produce WFPD, nevertheless, two sterile sterilizing grade filters 90a and 90b may be provided in the illustrated embodiment for redundancy in case one fails.

[0088] FIG. 2 further illustrates that a last bag or sample line 72 may be provided that extends from a last bag or sample port of cassette 42. Last bag or sample line 72 terminates at a connector 74, which may be connected to a mating connector of a premixed last fill bag of dialysis fluid or to a sample bag or other sample collecting container. Last bag or sample line 72 and connector 74 may be used alternatively for a third type of concentrate if desired.

[0089] FIGS. 1 and 2 illustrate that disposable set 40 includes a first, e.g., glucose, concentrate line 76 extending from a first concentrate port of cassette 42 and terminates at a first, e.g., glucose, cassette concentrate connector 80a. A second, e.g., buffer, concentrate line 78 extends from a second concentrate port of cassette 42 and terminates at a second, e.g., buffer, cassette concentrate connector 82a.

[0090] FIG. 1 illustrates that a first concentrate container 84a holds a first, e.g., glucose, concentrate, which is pumped from container 84a through a container line 86 to a first container concentrate connector 80b, which mates with first cassette concentrate connector 80a. A second concentrate container 84b holds a second, e.g., buffer, concentrate, which is pumped from container 84b through a container line 88 to a second container concentrate connector 82b, which mates with second cassette concentrate connector 82a.

[0091] In an embodiment, to begin treatment, patient P loads cassette 42 into cycler 20 and in a random or designated order (i) places heater/mixing bag 62 onto cycler 20, (ii) connects upstream water line segment 64a to water outlet connector 228 of water purifier 210, (iii) connects drain line 56 to drain connector 218 of water purifier 210, (iv) connects first cassette concentrate connector 80a to first container concentrate connector 80b, and (v) connects second cassette concentrate connector 82a to second container concentrate connector 82b. At this point, patient connector 52 is still capped. Once fresh dialysis fluid is prepared and verified, patient line 50 including sterile sterilizing grade filter 100 is primed with fresh dialysis fluid, after which patient P may connect patient line connector 52 to transfer set 54 for treatment. Each of the above steps may be illustrated graphically at video monitor 32 and/or be provided via voice guidance from speakers 34.

[0092] For disposable set 40, the rigid portion of cassette 42 may be made for example of a thermal olefin polymer of amorphous structure (“TOPAS”) cyclic olefin copolymer (“coc”). The flexible membranes of cassette 42 may be made for example of a copolyletser ether (“PCCE”) and may be of one or more layer. Any of the tubing or lines may be made for example of polyvinyl chloride (“PVC”). Any of the connectors may be made for example of acrylonitrile-butadiene-styrene (“ABS”, e.g., a connector 70 of heater/mixing bag or container 62 and/or for concentrate connectors 80a, 80b, 82a, 82b discussed below), acrylic (e.g., for drain line connector 58) or PVC (e.g., for water line connector water line connector 68). Any of the bags or containers, such as heater/mixing bag or container 62 discussed below, may be made of PVC. The materials for any of the above components may be changed over time. The housing for sterile sterilizing grade filter 100 may be made of any of the materials listed above.

[0093] Control unit 22 may be programmed to cause cycler 20 to perform one or more mixing action to help mix dialysis fluid properly and homogeneously for treatment. For example, any of fluid pump chambers 44 may be caused to withdraw into the pump chambers some amount of mixed fluid (e.g., made from one or both first and second concentrates 84a, 84b and purified water) from heater/mixing bag 62 and send such mixture back to heater/mixing bag 62 and repeat this procedure multiple times (described herein as a mixing sequence or “waffling”). In particular, to perform a mixing sequence, control unit 22 in an embodiment causes cycler 20 to close all fluid valve chambers 46 at cassette 42 except for the fluid valve chamber 46 to heater/mixing line 60 and heater/mixing bag 62. Fluid pump chambers 44 are stroked sequentially and repeatedly (i) pulling a possibly unmixed fluid combination of purified water and concentrates from heater/mixing bag 62 into the pump chambers, followed by (ii) pushing the mixed purified water and concentrates from the pump chambers back to heater/mixing bag 62 and (iii) repeating (i) and (ii) at least one time. Control unit 22 may be programmed to stroke fluid pump chambers 44 and associated valves 46 together so that they both pull and push at the same time, or alternatingly so that one pump chamber 44 pulls from heater/mixing bag 62, while the other pump chamber 44 pushes to heater/mixing bag 62, creating turbulence in heater/mixing line 60.

[0094] Providing container or bag 62 operable with cassette 42 and heater/mixing line 60 enables the purified water from accumulator 66 and the concentrates from first and second concentrate containers 84a and 84b to at least partially mix before entering the container or bag. Even if cassette 42 is not provided, however, the purified water and at least one concentrate will mix partially in heater/mixing line 60 prior to reaching the container or bag.

Patient Line Filter

[0095] Referring now to FIG. 3, a schematic illustration of an embodiment of patient line sterile sterilizing grade filter 100 is illustrated, showing flowpaths taken by fresh dialysis fluid mixed online at the point of use to the patient and used dialysis fluid returning from the patient. In an embodiment, control unit 22 of cycler 20 causes fluid pump chambers 44 and fluid valve chambers 46 of disposable cassette 42 to pump fresh dialysis fluid under positive pressure from right to left in FIG. 3 and from cassette 42 to patient P. Control unit 22 of cycler 20 causes fluid pump chambers 44 and fluid valve chambers 46 of disposable cassette 42 to pump used dialysis fluid under negative pressure fluid from left to right in FIG. 3 and from patient P to cassette 42.

[0096] Patient line sterile sterilizing grade filter 100 includes a filter housing 102, any one or more components of which may be made of any of the materials listed above, and which may be made of one or more molded, e.g., injection molded, piece. In the illustrated embodiment, housing 102 includes an elongated enclosure 104 sealed at two ends by a first port cap 106 and a second port cap 112. First port cap 106 includes a first port 108 and defines a first manifold or open area 110, while second port cap 112 includes a second port 114 and defines a second manifold or open area 116. First and second ports 108 and 112 may configured to connect sealingly to segments of patient line 50 via a compression fitting (ports have a compression connector), a hose barb fitting (ports have hose barbs), a luer connection (ports have a male or female luer connector), a stretching of the patient line fitting (outside diameter of the ports is larger than an inner diameter of segments of patient line 50) or combinations thereof.

[0097] FIG. 3 illustrates that filter housing 102 in one embodiment forms a used dialysis fluid pathway 118 and houses a fresh dialysis fluid pathway 120. First manifold or open area 110 and second manifold or open area 116 are able to receive both fresh and used dialysis fluids. The line with the arrows pointing to the right indicates used dialysis fluid flowing through used dialysis fluid pathway 118, while the line with the arrows pointing to the left indicates fresh dialysis fluid flowing through fresh dialysis fluid pathway 120. Fresh dialysis fluid pathway 120 as illustrated splits into a first, upper branch 122 and a second, lower branch 124. As illustrated in greater detail below, fresh dialysis fluid flows downwardly from first, upper branch 122 though multiple generally parallel passageways created by a first filter membrane and an inner grid into an interior region 126 of fresh dialysis fluid pathway 120. Similarly, fresh dialysis fluid flows upwardly from second, lower branch 124 though multiple generally parallel passageways created by a second filter membrane and the interior grid into the interior region 126 of fresh dialysis fluid pathway 120.

[0098] First port cap 106 houses a first one-way valve 150a, which is sealed to the structure forming fresh dialysis fluid pathway 120. Second port cap 112 houses a second one-way valve 150b, which is sealed to elongated enclosure 104 of filter housing 102 forming used dialysis fluid pathway 118 in the illustrated embodiment. First and second one-way valves 150a and 150b may be made of a medically safe rubber or plastic, such as silicone or any of the flexible materials listed above. First and second one-way valves 150a and 150b may be, for example, duckbill check valves.

[0099] As illustrated in FIG. 3, first one-way valve 150a is oriented such that it opens under positive pressure of the fresh dialysis fluid delivered through fresh dialysis fluid pathway 120 by pumping cassette 42. Fresh dialysis fluid exiting one-way valve 150a flows through first port 108 of first port cap 106 and a segment of patient line 50 to patient P. The orientation of one-way valve 150a however is such that valve 150a is closed under negative pressure from pumping cassette 42 pulling used dialysis fluid into filter 100 via first port 108 of first port cap 106. In this manner, used dialysis fluid is prevented from entering fresh dialysis fluid pathway 120 and contacting the filter membranes, which is desirable since filtering used dialysis fluid could remove contaminants from the used dialysis fluid, clog the filter membrane, and reintroduce the contaminants into the next cycle of fresh fluid.

[0100] As further illustrated in FIG. 3, second one-way valve 150b is oriented such that it opens under negative pressure of the used dialysis fluid pulled through used dialysis fluid pathway 118 by pumping cassette 42. Used dialysis fluid exiting one-way valve 150b flows through second port 114 of second port cap 112 and a segment of patient line 50 to disposable cassette 42. The orientation of one-way valve 150b however is such that valve 150b is closed under positive pressure from pumping cassette 42 pushing fresh dialysis fluid into filter 100 via second port 114 of second port cap 112. In this manner, all fresh dialysis fluid is forced to travel through fresh dialysis fluid pathway 120 including its filtering membranes.

[0101] Referring now to FIG. 4, patient line sterile sterilizing grade filter 100 is illustrated in more detail. Here, a section is taken through patient line 50, filter housing 102, used dialysis fluid pathway 118, fresh dialysis fluid pathway 120, first port cap 106, second port cap 112 and one-way valves 150a and 150b. As discussed above, filter housing 102 defines used dialysis fluid pathway 118 and holds one-way valve 150b in one embodiment. In FIG. 4, second port cap 112 may also be formed with or sealed to filter housing 102. As referred to herein, “sealed to” may but does not have to mean adhered to, ultrasonically welded to, solvent bonded to, mechanically sealed to, or be any combination thereof.

[0102] FIG. 4 illustrates that in one embodiment, the filter membranes, and one-way valve 150a may be held by a membrane housing 130 located within and sealed to filter housing 102. Membrane housing 130 may be made of any of the materials discussed herein, may be molded, e.g., injection molded, in one or more piece, and may be sealed to filter housing 102 and first port cap 106 via any of the techniques described herein. In the illustrated embodiment, first port cap 106 is sealed to membrane housing 130. In an alternative embodiment, port cap 106 may be formed with membrane housing 130.

[0103] In the illustrated embodiment of FIG. 4, both filter housing 102 and membrane housing 130 take part in forming fresh dialysis fluid pathway 120. Upper branch 122 of fresh dialysis fluid pathway 120 is located between an upper wall 128a of filter housing 102 and an upper wall of membrane housing 130 (which houses the upper filter membrane as illustrated below). Lower branch 124 of fresh dialysis fluid pathway 120 is located between a dividing wall 128b of filter housing 102 and a lower wall of membrane housing 130 (which houses the lower filter membrane as illustrated below). Interior region 126 of fresh dialysis fluid pathway 120 is located within membrane housing 130.

[0104] FIG. 4 better illustrates the structure and orientation of one-way valves 150a and 150b. One-way valve 150a may be sealed to, e.g., adhered to, membrane housing 130 and/or clamped between membrane housing 130 and first port cap 106. In the illustrated embodiment, one-way valve 150a is a duckbill check valve with its slitted duckbill angled towards patient P, such that positive fresh dialysis fluid pressure provided by pumping cassette 42 opens the slit from inside the check valve, and such that negative pressure from cassette 42 pumping used dialysis fluid cannot open the slit. One-way valve 150b may be sealed to, e.g., adhered to, filter housing 102 and/or clamped between filter housing 102 and second port cap 114 as illustrated. In the illustrated embodiment, one-way valve 150b is also a duckbill check valve with its slitted duckbill angled instead towards pumping cassette 42, such that negative used dialysis fluid pressure provided by pumping cassette 42 opens the slit from outside the check valve, and such that positive pressure from cassette 42 pumping fresh dialysis fluid cannot open the slit.

[0105] FIG. 4 also illustrates that elongated enclosure 104 of filter housing may include, e.g., be sealed to, one or more hydrophobic (air passing but liquid retaining) vents 152. Hydrophobic vents 152 allow air to escape sterile sterilizing filter 100, e.g., during priming and prior to treatment. Removing air from sterile sterilizing filter 100 helps to prevent air from reaching patient P. The air removal also helps to protect hydrophilic membranes 140 and 142.

[0106] Referring now to FIG. 5, membrane housing 130 is shown in more detail with filter housing 102 having been cutaway. Membrane housing 130 includes a mounting arm 132 sized and arranged to be sealed to filter housing 102 and first port cap 106 via any of the techniques discussed above. Mounting arm 132 is also sized and arranged to be sealed, e.g., adhered, to one-way valve 150a. Mounting arm 132 extends to a grid housing 134 shown in more detail below in connection with FIG. 6. Importantly in FIG. 5, grid housing 134 is illustrated as being sealed to upper and lower (first and second) filter membranes 140 and 142. First, upper membrane 140 filters fresh dialysis fluid flowing downwardly through first, upper branch 122, while second lower membrane 142 filters fresh dialysis fluid flowing upwardly through second, lower branch 124.

[0107] Filter membranes 140 and 142 are each hydrophilic membranes in one embodiment. Hydrophilic membranes in general allow liquid water to pass from one side of the membrane to the other and when properly wetted block air from such passing. Pore sizes for filter membranes 140 and 142 may, for example, be less than a micron, such as 0.1 or 0.2 micron. This pore size helps to remove any lingering contaminants or impurities in the fresh dialysis fluid from any of: the purified water used to make the fresh dialysis fluid, the concentrates used to make the fresh dialysis fluid, and/or any portion of disposable set carrying the purified water or concentrates to patient P.

[0108] Referring now to FIG. 6, membrane housing 130 discussed in connection with FIG. 5 is illustrated in more detail having filter membranes 140 and 142 removed, so that interior region 126 of fresh dialysis fluid pathway 120 inside membrane housing 130 may be viewed. In particular, grid housing 134 is illustrated in more detail. Grid housing 134 may be made (e.g., injection molded) from any of suitable material discussed herein. In the illustrated embodiment, grid housing 134 extends from mounting arm 132 of membrane housing 130. Grid housing 134 includes a plurality of baffles 136 that extend across grid housing 134 and separate filtered dialysis fluid that has flowed through filter membranes 140 and 142 into plural fluid channels 144 forming interior region 126 of fresh dialysis fluid pathway 120. Baffles 136 help support the thin filter membranes 140 and 142 and space the membranes a desired distance apart.

[0109] To maintain baffles 136 in their illustrated separated and generally parallel relationship, plural cross-braces 138 may be provided. Cross-braces 138 are sized (narrowed) to enable filtered dialysis fluid to flow along channels 144 defined by baffles 136, over the cross-braces, to a collection channel 146. Collection channel 146 in turn funnels the filtered dialysis fluid to first one-way valve 150a, after which the filtered dialysis fluid exits filter 100 into a downstream segment of patient line 50 as has been discussed herein.

[0110] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. 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. It is therefore intended that such changes and modifications be covered by the appended claims. For example, fluid pump chambers 44 may be pneumatically actuated pump chambers or be a section of peristaltic pumping tube. Similarly, valve chambers 46 may be pneumatically actuated, e.g., be volcano valves, or be sections of tubing operated upon by pinch valves. Likewise, the pump and valve actuators may be pneumatic actuators or be electromechanical actuators, e.g., a peristaltic pump actuator and pinch valves, respectively.