Dual chamber medical fluid container with vented supply line cap and method therefor - Patent Application 20070122997

Abstract

The medical fluid container tubing assembly includes a medical fluid container, a first Luer connector, tubing extending from the medical fluid container and terminating in the first Luer connector, and a cap fitted onto the first Luer connector. The cap includes a hydrophobic filter positioned and arranged to allow air to enter the tubing in a sterile manner to equalize pressure inside and outside the tubing. The medical fluid container tubing assembly also includes a supply line extending from the medical fluid destination and terminating in a second Luer connector. The second Luer connector is configured to mate with the first Luer connector when the cap is removed from the first Luer connector.

Description

[Technical Field]

[0001] Technical Field FIELD OF THE DISCLOSURE The present disclosure relates generally to medical fluid treatments, and more particularly to medical fluid treatments using pre-made or bagged medical fluids. [Background technology]

[0002] background A variety of causes can cause a person's renal system to fail. Renal failure produces several physiological disturbances: it is no longer possible to balance water and minerals or excrete the daily metabolic load. Toxic end products of metabolism, such as urea, creatinine, uric acid, and others, can accumulate in the patient's blood and tissues.

[0003] Reduced kidney function, especially kidney failure, is treated using dialysis. Dialysis removes waste products, toxins, and excess water from the body that normally would be removed by normally functioning kidneys. Dialysis treatment for kidney function replacement is extremely important for many people because the treatment is life-saving.

[0004] One type of kidney failure therapy is hemodialysis ("HD"), which generally uses diffusion to remove waste products from a patient's blood. A diffusion gradient occurs across a semipermeable dialyzer between the blood and an electrolyte solution called the dialysate or dialysis fluid, causing diffusion.

[0005] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from the patient's blood. HF is achieved by adding replacement or substitution fluid to the extracorporeal circuit during treatment. The replacement fluid, and fluid accumulated by the patient between treatments, is ultrafiltered during the course of the HF treatment, providing a particularly useful convective transport mechanism for removing middle and large molecules.

[0006] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearance. HDF uses dialysis fluid flowing through a dialyzer, similar to standard hemodialysis, to provide diffusive clearance. In addition, replacement solution is provided directly to the extracorporeal circuit to provide convective clearance.

[0007] Most HD, HF, and HDF treatments occur in facilities. Today, there is a trend toward home hemodialysis ("HHD"), in part because HHD can be performed daily and offers therapeutic benefits over in-center hemodialysis treatments, which typically occur twice or three times per week. Studies have shown that more frequent treatments remove more toxins and waste products and result in less fluid overload between dialysis sessions than patients receiving less frequent but potentially longer treatments. Patients receiving more frequent treatments do not experience as much downcycling (fluctuations in fluid and toxins) as in-center patients who accumulate two or three days' worth of toxins before treatment. In certain areas, the nearest dialysis facility may be many miles from a patient's home, causing door-to-door treatment times to consume a significant portion of a patient's day. Treatments at facilities closer to the patient's home may also consume a significant portion of a patient's day. HHD can be performed at night or during the day when the patient is relaxing, working, or otherwise productive.

[0008] Another type of renal failure therapy is peritoneal dialysis ("PD"), in which a dialysis solution, also called dialysis fluid or PD fluid, is infused through a catheter into a patient's peritoneal cavity. The PD fluid contacts the peritoneal membrane within the patient's peritoneal cavity. Waste, toxins, and excess water enter the PD fluid from the patient's bloodstream through the peritoneal capillaries by diffusion and osmosis, creating an osmotic gradient across the membrane. An osmotic agent in the PD fluid provides the osmotic gradient. The spent PD fluid is pumped out of the patient, removing the waste, toxins, and excess water from the patient. This cycle may be repeated, for example, multiple times.

[0009] There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis procedure. In this procedure, a patient manually connects an implanted catheter to a drain, allowing spent PD fluid to drain from the patient's peritoneal cavity. The patient then switches the fluid communication, connecting the patient's catheter to a bag of fresh PD fluid and infusing the fresh PD fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh PD fluid, allowing the PD fluid to dwell in the patient's peritoneal cavity, transporting waste, toxins, and excess water. After the dwell period, the patient repeats the manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires significant patient time and effort and leaves significant room for improvement.

[0010] APD is similar to CAPD in that the dialysis treatment involves drain, fill, and dwell cycles. APD machines, however, perform these cycles automatically, typically while the patient sleeps. APD machines relieve patients of having to manually perform treatment cycles and transport supplies during the day. APD machines are fluidly connected to an implanted catheter, a source or bag of fresh PD fluid, and a fluid drain. The APD machine pumps fresh PD fluid from the dialysis fluid source through the catheter and into the patient's peritoneal cavity. APD machines also allow the PD fluid to dwell within the cavity, transporting waste, toxins, and excess water. The source may contain multiple liters of dialysis fluid, including several solution bags.

[0011] The APD machine pumps spent PD fluid from the patient's peritoneal cavity and drains it through the catheter. Similar to the manual process, several drain, fill, and dwell cycles occur during dialysis. A "final fill" may occur at the end of an APD treatment. The final fill fluid may remain in the patient's peritoneal cavity until the start of the next treatment, or it may be manually emptied at some point during the day.

[0012] Any of the above treatment modalities can operate using pre-made (e.g., bagged) solutions. Bagged solutions are typical for any type of PD (CAPD or APD). Bagged solutions may also be used for HD, particularly HHD (see, e.g., U.S. Pat. No. 8,029,454, assigned to the assignee of the present application). Continuous renal replacement therapy ("CRRT") is an acute form of HD, HF, or HDF and typically uses bagged dialysis fluid. Dual-chamber bagged solutions are also provided, in which different solution components are separated until use.

[0013] Prefabricated (e.g., bagged) solutions for any of the above modalities are typically sterilized after filling and then stoppered to maintain the medical fluid in a sterile state until use. There are various methods for accessing the sterile solution at the time of use. One method is to spike a connector at the time of use, establishing medical fluid flow between the bag and the point of use (such as the patient or a disposable cassette). Another method, very common in PD, is to use a frangible frangible. The patient or caregiver bends the frangible frangible to snap it open, subsequently allowing fluid flow. A further method is to make a Luer connection, a known connection that involves threading mating Luer connectors together to form a fluid-tight seal between the connectors.

[0014] Regardless of the type of connection made, a bag tube is typically provided that extends from the bag to the connector, allowing play or space for an operator to grasp and manipulate the connector while making a fluid-tight connection to the mating connector. Steam sterilization of bagged solutions has been found to collapse the bag tube. Here, the steam outside the bag tube is at a higher pressure than the air inside the bag tube, forcing air through the tube into the bag, thereby collapsing the tube. If the tube does not reopen after steam sterilization, the bag tube becomes blocked when the solution bag is connected for use.

[0015] Therefore, there is a need for an improved apparatus and related methodology for steam sterilization of bagged dialysis treatment solution, and a need for a safe manner for releasing the dual-chamber bagged dialysis treatment solution so that a properly mixed solution reaches the patient. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] U.S. Patent No. 8,029,454 Summary of the Invention [Means for solving the problem]

[0017] overview The present disclosure involves the use of a vented medical fluid supply line cap for use with a solution container or bag operable with any type of dialysis treatment, including any type of peritoneal dialysis ("PD") treatment, hemodialysis ("HD") treatment, hemofiltration ("HF") treatment, hemodiafiltration ("HDF") treatment, or continuous renal replacement therapy ("CRRT") treatment. It should be understood that the vented medical fluid supply line cap may be used in any type of medical treatment having bagged or otherwise stored medical fluids, which must be opened under sterile conditions for use and steam sterilized. Thus, the vented medical fluid supply line cap may also be used with any type of bagged medical infusion or intravenous fluid, such as saline, lactated Ringer's, etc.

[0018] In one embodiment, the vented medical fluid supply line cap is configured to cap a Luer connector. However, it should be understood that the medical fluid supply line cap need not cap a Luer connector, but may instead cap a different type of connector. In either case, the cap caps a short line or tubing, also referred to as a pigtail, that extends from a medical fluid supply container (e.g., a flexible bag). The flexible bag may be a single-chamber bag that holds a thoroughly mixed medical fluid, or may be a multi-chamber bag with one or more peel seals that separate medical fluid components that need to be isolated until use.

[0019] The vented medical fluid supply line cap, in one embodiment, is formed, e.g., unitarily molded, from a polymer such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC") polyvinyl chloride ("PVC"), nylon, polyetheretherketone ("PEEK"), and / or a thermoplastic elastomer such as those commercially available under the trade name Hytrel®. The medical fluid container or bag and bag tubing (which may be a short length of tubing or pigtail) may be made of PVC or other suitable medically safe material.

[0020] When the vented medical fluid supply line cap is configured to cap a luer connector, in one embodiment the cap is configured with a female luer feature, and the luer connector is a male luer connector. In an alternative embodiment, the cap may be provided with a male luer feature, and the luer connector is a female luer connector. When the vented medical fluid supply line cap is configured with a female luer feature, the cap includes a body having an inner port and an outer shroud. The inner surface of the inner port, in one embodiment, includes a female luer taper that forms an interference fit with the outer surface of the inner male luer port of the mating male luer connector. The outer surface of the inner port, in one embodiment, is provided with a plurality of ribs extending longitudinally, for example along the outer wall. The ribs form a secondary interference fit with female threads provided on the inner surface of the outer shroud of the mating male luer connector. The female threads threadably connect to the male threads of the female luer connector to establish medical fluid flow when the vented medical fluid supply line cap is removed from the male luer connector.

[0021] The inner surface of the outer shroud, in one embodiment, is sized to provide a slight amount of clearance with the outer surface of the outer shroud of the mating male luer connector, which clearance allows the interference fit between the inner surface of the cap's inner port and the outer surface of the inner male luer port of the mating male luer connector to be a primary interference fit that prevents leakage of medical fluids from the vented medical fluid supply line cap of the present disclosure.

[0022] In one embodiment, the vented medical fluid supply line cap is translated onto and away from a mating male luer connector with an interference fit that holds the cap on the male luer connector. In an alternative embodiment, the ribs on the exterior surface of the cap's inner port are replaced with male luer threads that threadably connect with female luer threads on the interior surface of the outer shroud of the mating male luer connector. Here, the cap threads onto and unthreads off the mating male luer connector in the same manner as a female luer connector used to establish medical fluid flow. In either situation (translation or threading), the outer surface of the outer shroud of the cap is formed with a plurality of ribs (e.g., longitudinally extending ribs) that assist the user in translating the cap onto or away from the mating male luer connector, or in threading or unthreading the cap onto or away from the mating male luer connector.

[0023] In one embodiment, a lumen formed by the inner surface of the internal port extends through the body to and through the circular distal end of the body. An enlarged cavity is integrally formed in the distal end of the body. The cavity provides a location for mounting a vent, such as a hydrophobic membrane filter, within the cavity so that the opening through the body of the cap is covered. The hydrophobic filter or vent allows air, but not medical fluid, to flow into or out of the body of the cap through the filter or vent. Air entering the body of the cap is also sterilely filtered through the hydrophobic filter or vent. In one embodiment, the hydrophobic filter or vent comprises a 0.2 micron polytetrafluoroethylene ("PTFE") hydrophobic membrane with a polyester substrate. The hydrophobic filter or vent may be sealed to the cavity of the body around the outer diameter of the hydrophobic filter or vent via heat sealing, ultrasonic sealing, or solvent bonding.

[0024] When a medical fluid container or bag filled with medical fluid having a bag tube (e.g., a short tube or pigtail) extending from the container (stoppered by a vented cap of the present disclosure) is steam sterilized, the hydrophobic filter or vent prevents the short tube or pigtail from collapsing. Steam sterilization typically involves placing many medical fluid containers or bags in an autoclave at the same time to be steam sterilized. The external environment around the medical fluid containers or bags fills with steam, which increases the pressure inside the autoclave above ambient pressure (e.g., 15 to 30 psi (1.0 to 2.0 bar)) as temperatures inside the autoclave can reach 121°C (250°F). Without the vented cap of the present disclosure, the short tube or pigtail often collapses under the increased external pressure, forcing air within the short tube or pigtail into the medical fluid container or bag. Heating the thermoplastic tube or pigtail to sterilization temperatures can cause the thermoplastic tube or pigtail to become somewhat tacky. The collapsed tubing thereby tends to seal against itself, even after removal from the autoclave and cooling. In use, the collapsed tubing can impede successful medical fluid (e.g., PD fluid) flow from the medical fluid container or bag to the desired treatment destination (e.g., a PD machine or cycler) or to the patient's peritoneal cavity for continuous ambulatory peritoneal dialysis ("CAPD").

[0025] It is therefore expressly contemplated to provide an improved method for steam sterilizing medical fluid containers, such as PD fluid bags, in which a vented medical fluid supply line cap allows pressurized air from the surrounding autoclave atmosphere to enter the cap and small tubing or pigtail. The pressurized air entering the small tubing or pigtail equalizes pressure on both sides of the tubing, preventing it from collapsing. Additionally, air heated to a sterilization temperature (e.g., 121°C (250°F)) entering the small tubing and portions of the container or bag through a hydrophobic filter or vent directly brings the sterilization temperature to contacted surfaces (including portions of the medical fluid held within the container), eliminating the need for heat conduction through the walls of the tubing and container or bag. This improves sterilization and sterilization efficiency.

[0026] In a first aspect, which may be combined with any other aspect or portion thereof described herein without limiting the disclosure in any way in light of the disclosure set forth herein, a medical fluid container tubing assembly includes a medical fluid container, a first luer connector, tubing extending from the medical fluid container and terminating in the first luer connector, and a cap fitted onto the first luer connector. The cap includes a hydrophobic filter positioned and arranged to allow air to enter the tubing in a sterile manner to equalize pressure inside and outside the tubing. The medical fluid container tubing assembly also includes a supply line extending from a medical fluid destination and terminating in a second luer connector. The second luer connector is configured to mate with the first luer connector when the cap is removed from the first luer connector.

[0027] In a second aspect that may be combined with any other aspect or portion thereof described herein, the medical fluid container is a multi-chamber medical fluid container including at least one peel seal separating at least two chambers.

[0028] In a third aspect that may be combined with any other aspect or portion thereof described herein, the first luer connector is a male luer connector and the second luer connector is a female luer connector.

[0029] In a fourth aspect that may be combined with any other aspect or portion thereof described herein, the second luer connector is configured to connect to a connector of a medical fluid machine to form part of a disinfection loop.

[0030] In a fifth aspect that may be combined with any other aspect or portion thereof described herein, the supply line is configured to be fluidly connected at its medical fluid destination end to a disposable cassette operated within or by a medical fluid machine.

[0031] In a sixth aspect that may be combined with any other aspect or portion thereof described herein, the cap and the first luer connector are configured such that the cap translates onto and away from the first luer connector.

[0032] In a seventh aspect that may be combined with any other aspect or portion thereof described herein, the cap and the first luer connector are configured such that the cap can be threaded onto and unthreaded from the first luer connector.

[0033] In an eighth aspect that may be combined with any other aspect or portion thereof described herein, the first luer connector includes a luer port, and the cap includes a port sized to provide an interference fit with the luer port of the first luer connector.

[0034] In a ninth aspect that may be combined with any other aspect or portion thereof described herein, the luer port is a male luer port, and the inner surface of the port in the cap is sized and shaped to provide an interference fit with the outer surface of the male luer port.

[0035] In a tenth aspect that may be combined with any other aspect or portion thereof described herein, the first luer connector includes an outer shroud, and an outer surface of the port of the cap includes at least one rib sized to provide a second interference fit with an inner surface of the outer shroud of the first luer connector.

[0036] In an eleventh aspect that may be combined with any other aspect or portion thereof described herein, the first luer connector includes a first outer shroud, and the cap includes a second outer shroud, and the first outer shroud and the second outer shroud are sized such that a clearance space exists between an outer surface of the first outer shroud and an inner surface of the second outer shroud.

[0037] In a twelfth aspect that may be combined with any other aspect or portion thereof described herein, an outer surface of the second outer shroud includes at least one rib for gripping the cap for connecting and disconnecting the cap from the first luer connector.

[0038] In a thirteenth aspect that may be combined with any other aspect or portion thereof described herein, the cap defines a lumen in fluid communication with the tube, and the hydrophobic filter covers the opening formed by the lumen.

[0039] In a fourteenth aspect that may be combined with any other aspect or portion thereof described herein, the cap and the first luer connector are configured such that the maximum force required to remove the cap from the first luer connector is 37 Newtons.

[0040] In a fifteenth aspect that may be combined with any other aspect or portion thereof described herein, a tubing assembly includes a first luer connector and a cap fitted onto the first luer connector. The cap includes a hydrophobic filter, the hydrophobic filter positioned and arranged to allow air to enter the tubing in a sterile manner to equalize pressure inside and outside the tubing. The tubing assembly also includes a supply line extending from a medical fluid destination and terminating in a second luer connector. The second luer connector is configured to mate with the first luer connector when the cap is removed from the first luer connector.

[0041] In a sixteenth aspect that may be combined with any other aspect or portion thereof described herein, the first luer connector includes a luer port, and the cap includes a port sized to provide an interference fit with the luer port of the first luer connector.

[0042] In a seventeenth aspect that may be combined with any other aspect or portion thereof described herein, the luer port is a male luer port, and the inner surface of the port in the cap is sized and shaped to provide an interference fit with the outer surface of the male luer port.

[0043] In an eighteenth aspect that may be combined with any other aspect or portion thereof described herein, the first luer connector includes an outer shroud, and an outer surface of the port of the cap includes at least one rib sized to provide a second interference fit with an inner surface of the outer shroud of the first luer connector.

[0044] In a 19th aspect that may be combined with any other aspect or portion thereof described herein, the first luer connector includes a first outer shroud, and the cap includes a second outer shroud, and the first outer shroud and the second outer shroud are sized such that a clearance space exists between an outer surface of the first outer shroud and an inner surface of the second outer shroud.

[0045] In a twentieth aspect that may be combined with any other aspect or portion thereof described herein, the outer surface of the second outer shroud includes at least one rib for gripping the cap for connecting and disconnecting the cap from the first luer connector.

[0046] In a twenty-first aspect, any of the features, functions, and alternatives described in connection with any one or more of Figures 1-11 may be combined with any of the features, functions, and alternatives described in connection with any other of Figures 1-11.

[0047] Therefore, in light of the above aspects and the present disclosure described herein, it is an advantage of the present disclosure to provide a medical fluid supply line cap that is vented.

[0048] Another advantage of the present disclosure is providing a medical fluid supply line cap that prevents the line from collapsing during steam sterilization.

[0049] A further advantage of the present disclosure is that it provides a medical fluid supply line cap that can be used with many different medical fluids.

[0050] Yet another advantage of the present disclosure is that it provides an improved method for steam sterilizing medical fluid containers, such as PD fluid supply bags.

[0051] Additional features and advantages are described in, and will be apparent from, the following detailed description and drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those skilled in the art upon consideration of the drawings and description. Also, it is not necessary for any particular embodiment to possess all of the advantages enumerated herein, and it is expressly contemplated that each advantageous embodiment may be separately claimed. Furthermore, it should be noted that the language used herein has been chosen primarily for readability and instructional purposes, and not to limit the scope of the inventive subject matter. [Brief explanation of the drawings]

[0052] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] FIG. 1 is a schematic diagram of one embodiment of fluid flow in a medical fluid system (eg, a PD fluid system) set up for treatment.

[0053] [Figure 2] FIG. 2 is a schematic diagram of one embodiment of fluid flow in a medical fluid system (eg, a PD fluid system) configured for disinfection.

[0054] [Figure 3] FIG. 3 is a cross-sectional elevational view of one embodiment of a medical fluid container tubing assembly of the present disclosure including a container tube, a mating male luer connector, and a vented medical fluid supply line cap.

[0055] [Figure 4] FIG. 4 is a perspective view of one embodiment of a medical fluid container tubing assembly of the present disclosure including a container tube, a mating male luer connector, and a vented medical fluid supply line cap.

[0056] [Figure 5] FIG. 5 is a perspective view of one embodiment of a vented medical fluid supply line cap of the present disclosure.

[0057] [Figure 6] FIG. 6 is a cross-sectional perspective view of one embodiment of a vented medical fluid supply line cap of the present disclosure.

[0058] [Figure 7] FIG. 7 is a cross-sectional elevation view of one embodiment of a vented medical fluid supply line cap just prior to application to a mating male luer connector.

[0059] [Figure 8] FIG. 8 is a cross-sectional elevation view of one embodiment of a vented medical fluid supply line cap applied to a mating male luer connector.

[0060] [Figure 9] FIG. 9 is a cross-sectional elevation view of detail A of FIG.

[0061] [Figure 10] FIG. 10 is a cross-sectional elevation view of detail B of FIG.

[0062] [Figure 11] FIG. 11 is a perspective view of one embodiment of a medical fluid container tubing assembly of the present disclosure including a medical fluid container, container tubing connected to a male luer connector, a vented medical fluid supply line cap removed, and a mating female luer connected to the medical fluid supply line. DETAILED DESCRIPTION OF THE INVENTION

[0063] Detailed Description System Overview Referring now to the drawings, and particularly to FIG. 1 , a medical system operable with a multi-chamber medical fluid container tubing assembly 110, described below, is illustrated via a peritoneal dialysis (“PD”) system 10. System 10 includes a medical machine, such as a PD machine or cycler 20, and a control unit 100 having one or more processors 102, one or more memories 104, a video controller 106, and a user interface 108. Alternatively or additionally, user interface 108 may be a remote user interface, e.g., via a tablet or smartphone. Control unit 100 may also include a transceiver and a wired or wireless connection to a network (not shown), e.g., the Internet, for transmitting treatment data to and receiving prescription orders / changes from a physician or clinician server, which interfaces with a physician or clinician's computer. In one embodiment, control unit 100 controls all electrical fluid flow and heating components of system 10 and receives outputs from all sensors in system 10. The system 10 in the illustrated embodiment includes durable, reusable components that come into contact with unused and used PD fluids, requiring the PD machine or cycler 20 to be disinfected between treatments, e.g., by thermal disinfection.

[0064] System 10 of FIG. 1 includes an in-line resistance heater 56, reusable supply lines or tubes 52a1-52a4 and reusable supply line or tube 52b, an air trap 60 operating with upper and lower level sensors 62a and 62b, respectively, an air trap valve 54d, a vent valve 54e located along vent line 52e, reusable line or tube 52c, a PD fluid pump 70, temperature sensors 58a and 58b, pressure sensors 78a, 78b1, 78b2, and 78c, and a reusable supply line or tube 52c having valve 54f. The system includes a reusable patient tubing or line 52g having a reusable patient tubing or line 52f and a valve 54g, a reusable dual-lumen patient line 28, a spring-activated hose reel 80 for retracting the patient line 28, a reusable drain tubing or line 52i extending to a drain line connector 34 and having a drain line valve 54i, and a reusable recirculation tubing or line 52r1 operating with a disinfection valve 54r1 and a reusable recirculation tubing or line 52r2 operating with a disinfection valve 54r2. A third recirculation or disinfection tubing or line 52r3 extends between disinfection or PD fluid line connector 30a and disinfection or PD fluid line connector 30b for use during disinfection. A fourth recirculation or disinfection tubing or line 52r4 extends between disinfection connector 30c and disinfection connector 30d for use during disinfection.

[0065] System 10 further includes medical fluid (e.g., PD fluid) containers or bags 38a-38c (e.g., holding the same or different formulations of PD fluid) that connect to distal connectors 24e of reusable PD fluid lines 24a-24c, respectively. System 10d further includes a fourth PD fluid container or bag 38d that connects to distal connector 24e of reusable PD fluid line 24d. Fourth PD fluid container or bag 38d may hold the same or a different type of PD fluid (e.g., icodextrin) as provided in PD fluid containers or bags 38a-38c. Reusable PD fluid lines 24a-24d, in one embodiment, extend through openings (not shown) defined or provided by housing 22 of cycler 20.

[0066] In the illustrated embodiment, system 10 includes four disinfection or PD fluid line connectors 30a-30d for connection to distal end connectors 24e of reusable PD fluid lines 24a-24d, respectively, during disinfection. System 10 also provides patient line connector 32 including an internal lumen (e.g., a U-shaped lumen) that directs unused or used dialysis fluid from one PD fluid lumen to the other PD fluid lumen of connected distal end 28e of reusable dual-lumen patient line 28 for disinfection. Reusable supply tubing or line 52a1 communicates with reusable supply line 24a, reusable supply tubing or line 52a2 communicates with reusable supply line 24b, reusable supply tubing or line 52a3 communicates with reusable supply line 24c, and reusable supply tubing or line 52a4 communicates with reusable supply line 24d. Reusable supply tubing or line 52a1 operates with valve 54a to allow PD fluid to be drawn into cycler 20 from desired PD fluid container or bag 38a, reusable supply tubing or line 52a2 operates with valve 54b to allow PD fluid to be drawn into cycler 20 from desired PD fluid container or bag 38b, and reusable supply tubing or line 52a3 operates with valve 54c to allow PD fluid to be drawn into cycler 20 from desired PD fluid container or bag 38c. Three-way valve 94a in the illustrated example allows control unit 100 to select between (i) 2.27% (or other) glucose dialysis fluid from container or bag 38b or 38c and (ii) icodextrin from container or bag 38d. In the illustrated embodiment, icodextrin from container or bag 38d is connected to a normally closed port of three-way valve 94a.

[0067] System 10, in one embodiment, is configured such that drain line 52i during patient fill is fluidly connected downstream of PD fluid pump 70. In this way, if drain valve 54i fails or somehow leaks during patient fill of patient P, unused PD fluid is forced into disposable drain line 36 instead of potentially drawing used PD fluid into pump 70. Disposable drain line 36, in one embodiment, is removed for sanitization, and drain line connector 34 is capped via cap 34c, forming a closed sanitization loop. PD fluid pump 70 may be an inherently precise pump, such as a piston pump, or a less precise pump, such as a gear pump, that operates in cooperation with flow meters (not shown) to control the flow rate and volume of unused and used PD fluid.

[0068] System 10 may further include a leak detection pan 82 located at the bottom of housing 22 of cycler 20 and a corresponding leak detection sensor 84, which outputs to control unit 100. In the illustrated example, system 10 is provided with an additional pressure sensor 78c located upstream of PD fluid pump 70, which allows measurement of the suction pressure of pump 70 and helps control unit 100 more accurately determine pump volume. The additional pressure sensor 78c in the illustrated embodiment is located along vent line 52e, which may be filled with air or a mixture of air and PD fluid but should nevertheless be at the same negative pressure as the PD fluid located in PD fluid line 52c.

[0069] 1 includes redundant pressure sensors 78b1 and 78b2, one output of which is used for pump control as described herein, and the other pressure sensor output is a safety or watchdog output to ensure the control pressure sensor is reading accurately. Pressure sensors 78b1 and 78b2 are located along a line that includes third recirculation valve 54r3. System 10 may use one or more intersections marked with Xs in FIG. 1, which may (i) reduce the overall amount and volume of reusable internal tubing, (ii) reduce the number of valves required, and (iii) minimize the portion of the fluid circuit shared by both unused and used PD fluid.

[0070] 1 further includes an acid source, such as a citric acid container or bag 66. The citric acid container or bag 66 is in selective fluid communication with a second three-way valve 94b via a citric acid valve 54m located along a citric acid line 52m. In one embodiment, the citric acid line 52m is connected to a normally closed port of the second three-way valve 94b to provide a redundant valve between the disinfectant container or bag 66 and the PD fluid circuit during treatment. The redundant valve ensures that citric acid does not reach the treatment fluid line during treatment. Instead, citric acid is used during disinfection.

[0071] Control unit 100 in one embodiment uses feedback from any one or more of pressure sensors 78a-78c to enable PD machine 20 to deliver fresh, heated PD fluid to the patient at a pressure of, for example, 14 kPa (2.0 psig) or higher. Pressure feedback is used to enable PD machine 20 to remove spent PD fluid or drainage fluid from the patient at, for example, -5 kPa (-0.73 psig) to -15 kPa (-2.2 psig) (e.g., -9 kPa (-1.3 psig) or higher (more negative) pressures). Pressure feedback can be used in proportional, integral, derivative ("PID") pressure routines to pump fresh and spent PD fluid at desired positive or negative pressures.

[0072] An in-line resistance heater 56 under the control of the control unit 100 can heat the fresh PD fluid to body temperature (e.g., 37°C) for delivery to the patient P at a desired flow rate. In one embodiment, the control unit 100 uses feedback from the temperature sensor 58a in a PID temperature routine to pump the fresh PD fluid to the patient P at the desired temperature. The control and operation of the in-line resistance heater 56 for thermal disinfection is described in detail below.

[0073] 1 also illustrates that system 10 includes and uses a disposable filter set 40 in fluid communication with the unused and used PD fluid lumens of dual-lumen patient line 28. Disposable filter set 40 includes a disposable connector 42 that connects to the distal end 28e of reusable patient line 28. Disposable filter set 40 also includes a connector 44 that connects to the patient's transfer set. Disposable filter set 40 further includes a sterilizing-grade filter membrane 46 that further filters the unused PD fluid. In one embodiment, disposable filter set 40 serves as a last-resort filter for PD machine 20 and is heat-sterilized between treatments. Pathogens that may (although unlikely) remain after sterilization are filtered from the PD fluid through sterilizing-grade filter membrane 46 of disposable filter set 40.

[0074] FIG. 1 illustrates the configuration of system 10 for treatment with PD fluid container or bag 38a connected via reusable flexible PD fluid line 24a, PD fluid container or bag 38b connected via reusable flexible PD fluid line 24b, PD fluid container or bag 38c connected via reusable flexible PD fluid line 24c, and PD fluid container or bag 38d connected via reusable flexible PD fluid line 24d. Dual-lumen patient line 28 is connected to patient P via disposable filter set 40. Disposable drain line 36 is connected to drain line connector 34. In FIG. 1, PD machine or cycler 20 of system 10 is configured to perform multiple patient drain, patient fill, patient dwell, and priming procedures as part of or in preparation for treatment.

[0075] 2 illustrates system 10 in disinfection mode. PD fluid container or bag 38a is removed and, instead, flexible PD fluid line 24a is sealed and plugged into disinfection or PD fluid line connector 30a; PD fluid container or bag 38b is removed and, instead, flexible PD fluid line 24b is sealed and plugged into disinfection or PD fluid line connector 30b; PD fluid container or bag 38c is removed and, instead, flexible PD fluid line 24c is sealed and plugged into disinfection or PD fluid line connector 30c; and PD fluid container or bag 38d is removed and, instead, flexible PD fluid line 24d is sealed and plugged into disinfection or PD fluid line connector 30d. Reusable dual-lumen patient line 28 is disconnected from disposable filter set 40 (which is discarded), and distal end 28e of dual-lumen patient line 28 is sealed and plugged into patient line connector 32. The disposable drain line 36 is disconnected from the drain line connector 34 and discarded. The drain line connector 34 is capped via cap 34c, forming a closed disinfection loop 90. The PD machine or cycler 20 of the system 10 of FIG. 2 is configured to perform a disinfection sequence (e.g., a thermal disinfection sequence in which unused PD fluid is heated to a disinfection temperature (e.g., 75°C or above) via the in-line heater 56). The PD fluid pump 70 circulates the heated PD fluid through the closed disinfection loop 90 for a time necessary to adequately disinfect the fluidic components and lines of the disinfection loop.

[0076] Multi-chamber medical fluid container assembly 3 and 4, one embodiment of a medical fluid container assembly 110 of the present disclosure is illustrated, including a container tube 112, a mating male luer connector 120, and a vented medical fluid supply line cap 150. The container tube 112 extends from one of the medical fluid containers or bags 38a-38d, and one or more of the medical fluid containers or bags 38a-38d may be a multi-chamber medical fluid container or bag (see FIGS. 1 and 11), with the containers or bags 38a-38d being considered part of the medical fluid container tube assembly 110. The medical fluid containers or bags 38a-38d are operable in any type of dialysis treatment using bagged dialysis fluid, including any type of peritoneal dialysis ("PD") treatment, hemodialysis ("HD") treatment, hemofiltration ("HF") treatment, hemodiafiltration ("HDF") treatment, or continuous renal replacement therapy ("CRRT") treatment. It should be understood that the vented medical fluid supply line cap 150 may be used in any type of medical treatment having bagged or otherwise stored medical fluid that must be opened in a sterile manner for use and is steam sterilized. Thus, the vented medical fluid supply line cap 150 may also be used with any type of bagged medical infusion or intravenous fluid, saline, lactated Ringer's, etc.

[0077] In one embodiment, the vented medical fluid supply line cap 150 is configured to cap a luer connector, such as the male luer connector 120. However, it should be understood that the medical fluid supply line cap 150 need not cap a luer connector but may instead cap a different type of connector, such as a connector that is spiked to allow medical fluid flow or a connector having spikes that spike a mating connector to allow medical fluid flow. In either case, the cap 150 in the illustrated embodiment caps a short line or tubing 112, also referred to as a pigtail, that extends a distance of less than one meter from a medical fluid supply container 38a-38d (e.g., a flexible bag). The flexible bags 38a-38d may be single-chamber bags that hold a thoroughly mixed medical fluid or may be multi-chamber bags (FIGS. 1 and 11) with one or more peel seals 38p, 38s that separate medical fluid components that need to be isolated until use. The short length of line or tubing 112 may be heat sealed, ultrasonically sealed, or solvent bonded to the male luer connector 120 .

[0078] The vented medical fluid supply line cap 150, in one embodiment, is formed (e.g., integrally molded) from a polymer such as polyetherimide ("PEI"), polyethersulfone ("PES"), polyamide / nylon ("PA"), acrylonitrile butadiene styrene ("ABS"), polycarbonate ("PC"), polyvinyl chloride ("PVC"), nylon, polyetheretherketone ("PEEK"), and / or a thermoplastic elastomer such as those commercially available under the trade name Hytrel®. The medical fluid containers or bags 38a-38d and the short tube or pigtail 112 may be made of PVC or other suitable medically safe material.

[0079] 3, 7, 8, and 9 illustrate an embodiment in which, when vented medical fluid supply line cap 150 is configured to cap a luer connector, the cap is configured to have a female luer feature, while the mating luer connector 120 is a male luer connector. Here, mating luer connector 120 is configured to connect to the distal end connector 24e of one of reusable PD fluid lines 24a-24d illustrated in FIGS. 1 and 2. Thus, distal end connector 24e of reusable PD fluid lines 24a-24d is now a female luer connector. In an alternative embodiment, cap 150 may be provided with a male luer feature, while mating luer connector 120 is a female luer connector and distal end connector 24e of reusable PD fluid lines 24a-24d is instead a male luer connector.

[0080] When a vented medical fluid supply line cap is configured with a female Luer feature as illustrated in Figures 3, 7, 8, and 9, the cap 150 includes a body 152 having or defining an inner port 154 and an outer shroud 156. The mating Luer connector 120, in turn, includes the body 122 having or defining an inner male Luer port 124 and an outer shroud 126. Figures 8 and 9 highlight that in one embodiment, the inner surface 154i of the inner port 154 includes or defines a female Luer taper (e.g., a 5-10 degree taper—modified as desired) that forms an interference fit with the outer surface 124o of the inner male Luer port 124 of the mating male Luer connector 120. Figures 6, 7, and 8 highlight that in one embodiment, the outer surface 154o of the inner port 154 is provided with a plurality of ribs 158 (e.g., extending longitudinally along the outer wall 154o). The ribs 158 form a secondary interference fit with the female threads on the inner surface 126i of the outer shroud 126 of the mating male luer connector 120. The female threads threadably connect to the male threads of the female luer distal end connector 24e (FIGS. 1 and 11) to establish medical fluid flow after the vented medical fluid supply line cap 150 is removed from the male luer connector 120.

[0081] 3, 9, and 10 highlight that the inner surface 156i of the outer shroud 156 of the vented medical fluid supply line cap 150 is sized in one embodiment to provide a slight amount of clearance space with the outer surface 126o of the outer shroud 126 of the mating male luer connector 120. The clearance space allows for an interference fit between the inner surface 154i of the inner port 154 of the cap 150 and the outer surface 124o of the inner male luer port 124 of the mating male luer connector 120 when the vented medical fluid supply line cap 150 is placed or mated onto the mating male luer connector 120, to be a primary interference fit that prevents medical fluid from leaking from the vented medical fluid supply line cap 150.

[0082] In one embodiment, the vented medical fluid supply line cap 150 is translated onto and away from the mating male luer connector 120 with the above-described interference fit holding the cap onto the male luer connector. Table 1 below shows that in one embodiment, the maximum translation removal force is set at 37 Newtons (“N”). Five different tests each confirmed that the vented medical fluid supply line cap 150 configuration shown herein meets the force removal objectives. [Table 1]

[0083] In an alternative embodiment, the plurality of ribs 158 on the outer surface 154o of the inner port 154 of the cap 150 are replaced with male luer threads that threadably connect with female luer threads on the inner surface 126i of the outer shroud 126 of the mating male luer connector 120. Here, the cap 150 threads onto the mating male luer connector 120 (forming a primary interference fit) and unthreads off the mating male luer connector 120 in the same manner as that used by the female luer distal end connector 24e to establish medical fluid flow. In either situation (translation or threading), Figures 5 and 6 illustrate that the outer surface 156o of the outer shroud 156 of the cap 150 is formed with a plurality of ribs 160 (e.g., longitudinally extending ribs) that assist the user in translating the cap 150 onto or away from the mating male luer connector 120, or in threading it onto or unthreading it away from the mating male luer connector 120.

[0084] 3, 6, 7, and 8 illustrate that, in one embodiment, the lumen L formed by the inner surface 154i of the inner port 154 of the vented medical fluid supply line cap 150 extends through the body 152 to and through the circular distal end 162 of the body. FIGS. 3-8 also illustrate that, in one embodiment, the distal end of the body 152 is provided with an enlarged cavity 164. The cavity 164 provides a location for mounting a vent 166, such as a hydrophobic membrane filter, within the cavity 164 to cover the opening or lumen L through the body 152 of the cap 150. In the illustrated embodiment, the cavity 164 is cylindrical, while the hydrophobic filter or vent 166 is circular. The hydrophobic filter or vent 166 allows air, but not medical fluid, to flow into or out of the body 152 of the cap 150 through the filter or vent. Additionally, air entering the body 152 of the cap 150 is sterile filtered through a hydrophobic filter or vent 166. In one embodiment, the hydrophobic filter or vent 166 comprises a 0.2 micron polytetrafluoroethylene ("PTFE") hydrophobic membrane with a polyester substrate. The hydrophobic filter or vent 166 may be sealed to the cavity 164 of the body 152 around the outer diameter of the hydrophobic filter or vent 166 via heat sealing, ultrasonic sealing, or solvent bonding.

[0085] When medical fluid containers or bags 38a-38d filled with medical fluid and having a short tube or pigtail 112 (capped by a vented cap 150 of the present disclosure) extending from the container are steam sterilized, the hydrophobic filter or vent 166 prevents the short tube or pigtail 112 from collapsing. Steam sterilization typically involves placing many medical fluid containers or bags simultaneously in an autoclave to be steam sterilized. The external environment around the medical fluid containers or bags fills with steam, which raises the temperature and pressure within the autoclave above ambient pressure (e.g., 15-30 psi (1.0-2.0 bar)) as temperatures within the autoclave can reach 121°C (250°F). Without the vented cap 150 of the present disclosure, the short tube or pigtail 112 would often collapse under the increased external pressure, forcing air within the short tube or pigtail 112 into the medical fluid container or bag. Heating the thermoplastic tubing or pigtail 112 to sterilization temperatures causes the thermoplastic tubing or pigtail 112 to become somewhat tacky, such that collapsed tubing tends to stick shut on itself, even after removal from the autoclave and cooling. In use, collapsed tubing can impede successful medical fluid (e.g., PD fluid) flow from medical fluid containers or bags 38a-38d to a desired treatment destination (e.g., PD machine or cycler 20) or to a patient's peritoneal cavity for continuous ambulatory peritoneal dialysis ("CAPD").

[0086] 3 and 6 illustrate that, expressly intended to provide an improved method for steam sterilizing medical fluid containers 38a-38d, such as PD fluid bags, the vented medical fluid supply line cap 150 allows pressurized air from the surrounding autoclave atmosphere to enter the cap and the small tube or pigtail 112. The pressurized air entering the small tube or pigtail 112 equalizes pressure on both sides of the tube, preventing it from collapsing. Additionally, the air heated to a sterilization temperature (e.g., 121°C (250°F)) entering the small tube 112 and a portion of the container or bag through the hydrophobic filter or vent 166 directly brings the sterilization temperature to the interior surface of the medical fluid container tubing assembly 110, including the tube 112, and potentially to a portion of the medical fluid held within the container, so that heat does not have to be conducted through the walls of the tube 112 and container or bag. This improves heat sterilization and the efficiency of heat sterilization.

[0087] FIG. 11 illustrates a medical fluid container tubing assembly 110 with a vented medical fluid supply line cap 150 removed and a mating male Luer connector 120 connected to the female Luer distal connector 24e of one of the reusable PD fluid lines 24a-24d. A short length of tubing or pigtail 112 extends from the male Luer connector 120 to a medical fluid (e.g., PD fluid) container or bag 38a-38c. In the illustrated embodiment, the container or bag 38a-38c is a dual-chamber bag that includes a first or primary peel seal 38p that separates the buffer solution chamber (marked "B") from the dextrose solution chamber (marked "D"). Buffer solution chamber B is larger than dextrose solution chamber D. While the dextrose solution has a pH of approximately 3.5, the buffer solution chamber is larger and holds a buffer solution having a pH of approximately 9.0. The two solutions are kept separate from one another to prevent particulate formation upon mixing. After the first or primary peel seal 38p is opened by the patient or caregiver and the component solutions are uniformly mixed, the resulting solution has a physiologically neutral pH of approximately 7.2 and is ready to be delivered to the patient.

[0088] Dual chamber bags 38a-38c are also provided with second or secondary peel seals 38s that prevent only the buffer solution from flowing to PD machine 20 or the patient through short tube or pigtail 112, male luer connector 120, and female luer distal connector 24e of one of reusable PD fluid lines 24a-24d. After the buffer solution and dextrose component solution are properly mixed, the resulting solution may be delivered to the patient.

[0089] FIG. 11 also illustrates the user interface 108 of the PD machine 20, which is shown to provide audible, visual, or audiovisual messages to the patient or caregiver for properly connecting and opening the dual-chamber bags 38a-38c (the icodextrin bag 38d is not a dual-chamber bag). In FIG. 11, the patient or caregiver is first instructed to remove the medical fluid supply line cap 150 from the mating male Luer connector 120. Second, the patient or caregiver is instructed to connect the male Luer connector 120 to the female Luer distal end connector 24e of one of the reusable PD fluid lines 24a-24c (shown as completed in FIG. 11). As illustrated in FIGS. 1 and 2, the PD fluid lines 24a-24c extend into fluid communication with the inner tubing of the PD machine 20. Third, the patient or caregiver is instructed to open the first or main peel seal 38p and thoroughly mix the buffer solution and the dextrose component solution. Fourth, the patient or caregiver is instructed to open the second or secondary ("delivery") peel seal 38s to allow the fully mixed PD fluid to be removed from the dual-chamber bags 38a-38c and used for the procedure.

[0090] 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. Accordingly, it is intended that any or all such changes and modifications may be covered by the appended claims. For example, although fluid lines 24a-24d are described as being reusable PD fluid lines extending within PD machine 20 to connect to internal tubing, PD fluid lines 24a-24d may instead extend to disposable PD fluid (or other medical fluid) cassettes operated by the PD machine (or other type of medical fluid treatment machine). Thus, fluid lines 24a-24d are disposable and may be used for any type of medical treatment described herein.

Claims

1. a medical fluid container; a first luer connector; a tube extending from the medical fluid container and terminating in the first luer connector; a cap fitted onto the first luer connector, the cap including a hydrophobic filter positioned and arranged to allow air to enter the tube in a sterile manner to equalize pressure inside and outside the tube; a supply line extending from a medical fluid destination and terminating in a second luer connector, the second luer connector configured to mate with the first luer connector when the cap is removed from the first luer connector; and 1. A medical fluid container tube assembly comprising:

2. 10. The medical fluid container tube assembly of claim 1, wherein the medical fluid container is a multi-chamber medical fluid container including at least one peel seal separating at least two chambers.

3. 10. The medical fluid container tubing assembly of claim 1, wherein the first luer connector is a male luer connector and the second luer connector is a female luer connector.

4. 10. The medical fluid container tube assembly of claim 1, wherein the second luer connector is configured to connect to a connector of a medical fluid machine to form part of a disinfection loop.

5. 10. The medical fluid container tube assembly of claim 1, wherein the supply line is configured at its medical fluid destination end to be fluidly connected within a medical fluid machine or to a disposable cassette operated by the medical fluid machine.

6. 10. The medical fluid container tube assembly of claim 1, wherein the cap and the first luer connector are configured for translation of the cap onto and away from the first luer connector.

7. 10. The medical fluid container tube assembly of claim 1, wherein the cap and the first luer connector are configured such that the cap threads onto and unthreads off the first luer connector.

8. 2. The medical fluid container tube assembly of claim 1, wherein the first luer connector includes a luer port, and the cap includes a port sized to provide an interference fit with the luer port of the first luer connector.

9. 9. The medical fluid container tube assembly of claim 8, wherein the luer port is a male luer port and the inner surface of the port in the cap is sized and shaped to provide an interference fit with the outer surface of the male luer port.

10. 9. The medical fluid container tube assembly of claim 8, wherein the first luer connector includes an outer shroud, and wherein an outer surface of the port of the cap includes at least one rib sized to provide a second interference fit with an inner surface of the outer shroud of the first luer connector.

11. 2. The medical fluid container tube assembly of claim 1, wherein the first luer connector includes a first outer shroud and the cap includes a second outer shroud, the first outer shroud and the second outer shroud being sized such that a clearance space exists between an outer surface of the first outer shroud and an inner surface of the second outer shroud.

12. 12. The medical fluid container tube assembly of claim 11, wherein an outer surface of the second outer shroud includes at least one rib for gripping the cap for connecting and disconnecting the cap from the first luer connector.

13. The medical fluid container tube assembly of claim 1 , wherein the cap defines a lumen in fluid communication with the tube, and the hydrophobic filter covers an opening formed by the lumen.

14. 10. The medical fluid container tube assembly of claim 1, wherein the cap and the first luer connector are configured such that a maximum force required to remove the cap from the first luer connector is 37 Newtons.

15. a first luer connector; a cap fitted onto the first luer connector, the cap including a hydrophobic filter positioned and arranged to allow air to enter the tube in a sterile manner to equalize pressure inside and outside the tube; a supply line extending from a medical fluid destination and terminating in a second luer connector, the second luer connector configured to mate with the first luer connector when the cap is removed from the first luer connector; and A tube assembly comprising:

16. 16. The tube assembly of claim 15, wherein the first luer connector includes a luer port, and the cap includes a port sized to provide an interference fit with the luer port of the first luer connector.

17. 17. The tube assembly of claim 16, wherein the luer port is a male luer port and the inner surface of the port in the cap is sized and shaped to provide an interference fit with the outer surface of the male luer port.

18. 17. The tube assembly of claim 16, wherein the first luer connector includes an outer shroud, and wherein an outer surface of the port of the cap includes at least one rib sized to provide a second interference fit with an inner surface of the outer shroud of the first luer connector.

19. 16. The tube assembly of claim 15, wherein the first luer connector includes a first outer shroud and the cap includes a second outer shroud, the first outer shroud and the second outer shroud being sized such that a clearance space exists between an outer surface of the first outer shroud and an inner surface of the second outer shroud.

20. 20. The tube assembly of claim 19, wherein an outer surface of the second outer shroud includes at least one rib for gripping the cap for connecting and disconnecting the cap from the first luer connector.

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