US20010027289A1 - Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration - Google Patents
Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration Download PDFInfo
- Publication number
- US20010027289A1 US20010027289A1 US09/878,443 US87844301A US2001027289A1 US 20010027289 A1 US20010027289 A1 US 20010027289A1 US 87844301 A US87844301 A US 87844301A US 2001027289 A1 US2001027289 A1 US 2001027289A1
- Authority
- US
- United States
- Prior art keywords
- regeneration
- solution
- water
- source
- peritoneal dialysis
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1694—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid
- A61M1/1696—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid with dialysate regeneration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/282—Operational modes
- A61M1/284—Continuous flow peritoneal dialysis [CFPD]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/288—Priming
Definitions
- the invention relates to systems and methods for performing peritoneal dialysis.
- PD Peritoneal Dialysis
- peritoneal dialysis solution dialysate
- Diffusion and osmosis exchanges take place between the solution and the bloodstream across the natural body membranes. These exchanges remove the waste products that the kidneys normally excrete.
- the waste products typically consist of solutes like sodium and chloride ions, and the other compounds normally excreted through the kidneys like urea, creatinine, and water.
- the diffusion of water across the peritoneal membrane during dialysis is called ultrafiltration.
- Conventional peritoneal dialysis solutions include dextrose in concentrations sufficient to generate the necessary osmotic pressure to remove water from the patient through ultrafiltration.
- CAPD Continuous Ambulatory Peritoneal Dialysis
- a patient performs CAPD manually about four times a day.
- the patient drains spent peritoneal dialysis solution from his/her peritoneal cavity.
- the patient then infuses fresh peritoneal dialysis solution into his/her peritoneal cavity. This drain and fill procedure usually takes about 1 hour.
- APD Automated Peritoneal Dialysis
- APD uses a machine, called a cycler, to automatically infuse, dwell, and drain peritoneal dialysis solution to and from the patient's peritoneal cavity.
- APD is particularly attractive to a PD patient, because it can be performed at night while the patient is asleep. This frees the patient from the day-to-day demands of CAPD during his/her waking and working hours.
- APD offers flexibility and quality of life enhancements to a person requiring dialysis.
- APD can free the patient from the fatigue and inconvenience that the day to day practice of CAPD represents to some individuals.
- APD can give back to the patient his or her waking and working hours free of the need to conduct dialysis exchanges.
- CAPD and APD as practiced today require the use of bagged solutions, which are expensive and difficult to handle and connect. Bagged solutions also do not permit the use of bicarbonate buffering solutions due to sterilization issues.
- the complexity and size of past machines and associated disposables for various APD modalities have dampened widespread patient acceptance of APD as an alternative to manual peritoneal dialysis methods.
- the invention provides systems and methods for conducting peritoneal dialysis.
- One aspect of the invention provides a system for conducting peritoneal dialysis.
- the system comprises a pumping assembly to circulate peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis.
- the pumping assembly includes an inlet branch to convey peritoneal dialysis solution into the peritoneal cavity and an outlet branch to withdraw peritoneal dialysis solution from the peritoneal cavity.
- the system also includes a regeneration assembly coupled in-line between the inlet and outlet branches.
- the regeneration assembly includes a source of a regeneration solution that carries at least one agent for regenerating spent peritoneal dialysis solution.
- the regenerating agent can include, e.g., an electrolyte and a buffering agent.
- the regeneration assembly also includes a porous membrane having a first side and a second side.
- the pumping assembly circulates peritoneal dialysis solution along the first side of the porous membrane from the outlet branch to the inlet branch.
- the regeneration solution is circulated along the second side of the porous membrane.
- the porous membrane is configured to transport waste from spent peritoneal dialysis solution into the regeneration solution and to transport the regenerating agent from the regeneration solution into spent peritoneal dialysis solution. The transport can occur, e.g., by diffusion, convection, or both.
- the regeneration assembly thereby operates to create from peritoneal dialysis solution in the outlet branch, a regenerated dialysis solution for conveyance through the inlet branch into the peritoneal cavity.
- the source of regeneration solution can draw water from a source of water, which can comprise, e.g., running tap water.
- the source of regeneration solution includes a device to treat water drawn from the source of water, as well as a device to mix the at least one regenerating agent with water drawn from the source of water.
- the source of regeneration solution can alternatively include a container holding a volume of water in which the at least one regenerating agent is mixed.
- the source of regeneration solution includes a first container holding a volume of water and a second container that holds the at least one regenerating agent.
- the second container is located within the first container.
- the second container includes a wall material that, when contacted by water, transports the at least one regenerating agent into the water, thereby forming the regeneration solution.
- the regeneration assembly includes a device to heat the regeneration solution before circulation along the second side of the porous membrane.
- the inlet branch communicates with a first access device providing access to the peritoneal cavity
- the outlet branch communicates a second access device providing access to the peritoneal cavity independent of the access provided by the first device.
- the pumping assembly can include a controller that withdraws peritoneal dialysis solution through the second access device into the regeneration assembly while conveying regenerated peritoneal dialysis solution from the regeneration device into the peritoneal cavity through the first access device.
- At least one of the first and second access devices can comprise, e.g., a subcutaneous access port.
- the inlet and outlet branches jointly communicate with a single access device that provides common access to the peritoneal cavity.
- the pumping assembly can include a controller operating in a draw mode, to withdraw peritoneal dialysis solution from the peritoneal cavity through the single access device into the regeneration assembly, and a return mode, to convey regenerated peritoneal dialysis solution into the peritoneal cavity through the single access device.
- the single access device comprises, e.g., a subcutaneous access port.
- the regeneration assembly includes a fluid balancing module to maintain a volumetric balance between waste and regenerating agent transported by the porous membrane.
- the regeneration assembly includes an ultrafiltration module to selectively transport a preselected greater volume of waste than regenerating agent.
- the pumping assembly can accommodate circulation of a cleaning or disinfecting agent through the inlet and outlet branches, bypassing the peritoneal cavity.
- the regeneration assembly can also accommodate circulation of a cleaning or disinfecting agent along the first and second sides of the porous membrane.
- Another aspect of the invention provides a method for conducting peritoneal dialysis.
- the method (i) circulates peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis by conveying peritoneal dialysis solution through an inlet branch into the peritoneal cavity and by withdrawing peritoneal dialysis solution through an outlet branch from the peritoneal cavity.
- the method (ii) conveys peritoneal dialysis solution in the outlet branch along a first side of a porous membrane while conveying a regeneration solution containing at least one regenerating agent along a second side of the porous membrane.
- the membrane is configured to transport the regenerating agent into the peritoneal dialysis solution while transporting waste from the peritoneal dialysis solution into the regeneration solution, thereby creating a regenerated peritoneal dialysis solution.
- the method (iii) circulates the regenerated peritoneal dialysis solution through the inlet branch into the peritoneal cavity.
- steps (ii), and (iii) can be performed simultaneously or sequentially.
- step (ii) a prescribed volumetric balance can be maintained between waste and regenerating agent transported by the porous membrane to achieve fluid balancing. Also during step (ii), a preselected greater volume of waste than regenerating agent cen be selectively transported by the porous membrane to achieve ultrafiltration. $$
- FIG. 1 is a schematic view of a system for conducting flow-through peritoneal dialysis, showing a dual access with the peritoneal cavity;
- FIG. 2 is a schematic view of a system for conducting flow-through peritoneal dialysis, showing a single access with the peritoneal cavity;
- FIG. 3 is a side section view of a subcutaneous peritoneal cavity access device, showing the associated valve assembly in a closed condition;
- FIG. 4 is a side section view of the subcutaneous peritoneal cavity access device shown in FIG. 3, showing the associated valve assembly in a closed condition;
- FIG. 5 is a schematic view of a system like that shown in FIG. 1, in which the regeneration solution is supplied in a batch process;
- FIG. 6 is a schematic view of a system like that shown in FIG. 1, in which the regeneration solution is supplied in a continuous process;
- FIG. 7 is a schematic view of the regeneration solution module like that shown in FIG. 1, which also includes fluid balancing and fluid removal capabilities.
- FIG. 1 shows a system 10 for conducting flow-through peritoneal dialysis, which embodies the features of the invention.
- the system 10 includes a peritoneal dialysis solution flow set 12 that is connected to an access device 18 .
- the access device 18 establishes communication between the system 10 and the peritoneal cavity 20 of a patient.
- the system 10 also includes a cycler 14 .
- the cycler 14 interacts with the flow set 12 , to pump peritoneal dialysis solution into and out of the patient's peritoneal cavity 20 .
- the system 10 also includes a controller 16 .
- the controller 16 governs the interaction between the set 12 and the cycler 14 , to perform a selected flow-through peritoneal dialysis procedure.
- the flow set 12 includes an in-line membrane device 22 .
- the membrane device 22 includes a housing 24 , which encloses a semipermeable membrane 26 .
- the membrane 26 can have different geometries.
- the membrane 26 comprises a bundle of hollow fibers, through which peritoneal dialysis fluid drawn from the peritoneal cavity 20 of the patient flows.
- the membrane 26 compartmentalizes the chamber 24 into a patient side 28 and a regeneration side 30 .
- the patient side 28 comprises the bores of the bundled hollow fibers
- the regeneration side 30 comprises the interior space surrounding the bundled hollow fibers.
- An inlet port 32 and an outlet port 34 convey dialysis solution into and out of the patient side 28 of the chamber 24 (i.e., into and out of the bores of the hollow fibers).
- An inlet port 36 and outlet port 38 convey regeneration solution into and out of the regeneration side 30 of chamber 24 .
- the set 12 circulates peritoneal dialysis solution, transported from the patient's peritoneal cavity 20 , along the patient side 28 of the membrane 26 .
- the set 12 also circulates a regeneration solution containing electrolytes and/or bicarbonate buffering materials along the regeneration side 30 of the membrane 26 .
- the cycler 14 creates and supplies the regeneration solution, as will be described in detail later.
- the pores of the membrane 26 are sized to pass, by diffusion and convection, waste and uremic toxins from the patient side 28 to the regeneration side 30 .
- the pores of the membrane 26 are also sized to pass, by the same transport mechanisms, electrolytes and bicarbonate buffering materials from the regeneration side 30 to the patient side 28 .
- the in-line membrane device 22 thereby makes possible the continuous, on-line regeneration of peritoneal dialysis solution circulated in the set 12 .
- the cycler 14 includes a fluid source 40 .
- the fluid source 40 comprises a water treatment module 42 , a regeneration solution module 44 , and a waste module 46 .
- the water treatment module 42 receives water from a household water supply and processes the water, using e.,g., filtration, or absorption, or filtration and absorption, or reverse osmosis (with or without pre-filtration and/or absorption), or de-ionization (with or without pre-filtration and/or absorption), or reverse osmosis and de-ionization (with or without pre-filtration and/or absorption).
- the water treatment module 42 creates water substantially free of pyrogens and microorganisms.
- the regeneration solution module 44 receives processed water from the water treatment module 42 .
- the regeneration solution module 44 mixes electrolytes and/or buffering agents with the processed water to create the regeneration solution.
- the module 44 verifies the make up of the solution and heats the solution to body temperature, for delivery to the regeneration side 30 of the membrane device 22 .
- the waste module 46 directs system drain and waste water from the regeneration side 30 of the membrane device 22 to a drain 56 or other selected receptacle.
- the fluid source 40 of the cycler 14 obviates the need for bagged solutions, except for initially priming the set 12 prior to conducting a flow-through peritoneal dialysis procedure.
- the fluid source 40 makes possible the continuous, on-line regeneration of peritoneal dialysis solution, which the set 12 circulates from and into the patient's peritoneal cavity 20 .
- the processing controller 16 can comprise a stand-alone micro-processor controlled module or a mechanically and /or electrically controlled module linked to the cycler 14 . In the illustrated embodiment, however, the cycler 14 and controller 16 are located within a common housing 48 .
- the housing 48 presents a compact footprint, suited for operation upon a table top or other relatively small surface normally found in the home.
- the controller 16 also includes an interactive user interface 50 .
- the interface 50 comprises some form of a display 52 , which can be analog or digital, and some form of a patient input device 54 , such as knobs, dials, switches, keyboard or a touch screen on the display 52 .
- the interface 50 can e.g., present on the display 52 the current status of the cycler 14 , or prompt the user to input commands and information, or receive data from the various sensors and other components of the cycler 14 , record the data in memory, or control the operation of the active components of the cycler 14 (such as valves, pumps, heaters, etc.), or alert the patient to abnormal or failure conditions in the cycler 14 with alarms or other indicators, or any or all of these functions.
- the interface 50 can be linked, e.g., by modem, to a central monitoring station or a central data collection site.
- the set 12 can be a single use, disposable item, or it can, with cleaning and disinfection, be reusable. This aspect with be described in greater detail later.
- the cycler 14 draws peritoneal dialysis solution from the patient's peritoneal cavity 20 , regenerates the dialysis solution, and returns the regenerated dialysis solution to the patient's peritoneal cavity 20 , in a continuous or semi-continuous, extracoporeal path.
- the constant or semi-constant flow of peritoneal dialysis solution through the peritoneal cavity 20 provides sustained, high clearance of waste and toxins, which are conveyed to the drain 56 .
- the on-line regeneration of dialysis solution provides lower costs and requires less manipulation and set up than systems relying upon the connection and disconnection of bagged solutions.
- the system 10 is particularly well suited to perform flow-through peritoneal dialysis (FTPD). For this reason, the use of the system 10 to perform various modalities of FTPD will be described in detail.
- FTPD flow-through peritoneal dialysis
- the access device 18 provides dual access, having a dedicated inlet 58 for conveying solution into the peritoneal cavity 20 and a dedicated outlet 60 for conveying solution from the peritoneal cavity 20 . Dual access provides continuous flow into and out of the peritoneal cavity 20 .
- Dual access can be provided, e.g., by a two indwelling catheters, a dual lumen, indwelling catheter, or two subcutaneous access devices. Further details of a preferred subcutaneous access device will be provided later.
- the set 12 includes a flexible inlet tube 62 with a connector 64 that connects to the peritoneal cavity outlet 60 .
- the inlet tube 62 also is also connected to the inlet port 32 on the patient side 28 of the membrane device 22 , to convey dialysis solution across the patient side 28 of the membrane 26 .
- the cycler 14 includes an inlet pump 66 .
- the inlet pump 66 comprises a peristaltic pump.
- the pump 66 includes rotating rollers 68 driven by a motor, e.g., a brushless D.C. motor.
- the rollers 68 in succession, press against and pinch the flexible inlet tube 62 against a pump race 70 , thereby urging liquid flow from the peritoneal cavity 20 through the inlet tube 62 across the patient side 28 of the membrane device 22 in known peristaltic fashion.
- a motor e.g., a brushless D.C. motor.
- the rollers 68 in succession, press against and pinch the flexible inlet tube 62 against a pump race 70 , thereby urging liquid flow from the peritoneal cavity 20 through the inlet tube 62 across the patient side 28 of the membrane device 22 in known peristaltic fashion.
- other types of noninvasive pumps can be used, provided that pump speed can be monitored and controlled.
- the set 12 further includes an outlet tube 72 , which is coupled to the outlet port 34 of the patient side 28 of membrane device 22 .
- the outlet tube 72 conveys regenerated dialysis solution from the patient side 28 of the membrane 26 .
- the outlet tube 72 carries a connector 74 that couples to the peritoneal cavity inlet 58 , to further convey the regenerated dialysis solution into the patient's peritoneal cavity 20 .
- the cycler 14 also includes two noninvasive pressure sensors 76 and 78 .
- the sensors 76 and 78 monitor fluid pressure, respectively, in the inlet tube 62 and the outlet tube 72 .
- the controller 16 analyzes the sensed pressures and regulates the inlet pump 66 to maintain the pressure in the outlet tube 72 within a predetermined safe range.
- the controller 16 also terminates operation of the inlet pump 66 if sensed pressure in the inlet tube 62 falls outside a predetermined range.
- the cycler 14 further includes a noninvasive fluid intake valve 80 .
- the controller 16 closes the intake valve 80 , to prevent the supply of dialysis solution to the peritoneal cavity 20 , should a predetermined alarm condition arise.
- the access device 18 provides a single access through a single indwelling catheter or a single subcutaneous access device.
- the single access arrangement provides semi-continuous flow of dialysis solution into and out of the peritoneal cavity 20 in a succession of draw modes and return modes.
- the quick cycling of draw and return modes provides virtually the same results as a continuous flow-through procedure, as just described.
- the set 12 includes a connector tube 82 with a connector 84 that connects to the single access device 18 .
- the connector tube 82 includes a y-connector 86 , to which the inlet tube 62 and the outlet tube 72 are connected.
- the inlet tube 62 is connected to the inlet port 32 of the membrane device 22 .
- the outlet tube 72 is coupled to the outlet port 34 of the membrane device 22 .
- the outlet tube 72 includes an in-line, non-vented reservoir 88 .
- the reservoir 88 receives regenerated dialysis solution from the membrane device 22 .
- a sensor 90 monitors fluid pressure in the reservoir 88 , which increases as solution fills the reservoir 88 and decreases as solution exits the reservoir 88 .
- the cycler 14 includes in the outlet tube 72 the same, previously described noninvasive fluid intake valve 80 .
- the cycler 14 also includes a noninvasive fluid removal valve 92 in the inlet tube 62 .
- the controller 16 toggles the fluid intake valve 80 and the fluid removal valve 92 between opposing opened and closed states, to affect successive fluid draw and fluid return modes.
- the fluid removal valve 92 is opened and the fluid intake valve 80 is closed.
- the inlet pump 66 conveys dialysis solution through the inlet tube 62 from the peritoneal cavity 20 into the membrane device 22 .
- the outlet tube 72 conveys regenerated dialysis solution from the membrane device 22 to the reservoir 88 .
- the controller 16 switches to the fluid return mode.
- the inlet pump 66 is stopped.
- the fluid intake valve 80 is opened, and the fluid removal valve 92 is closed.
- Regenerated dialysis solution flows by pressure from the reservoir 88 through the outlet tube 72 and into the peritoneal cavity 20 .
- the return mode terminates when the pressure condition in the reservoir 88 , as sensed by the sensor 90 , drops below a predetermined threshold.
- the controller 16 then switches to another fluid draw mode.
- the controller 16 cycles between successive fluid draw and return modes until the desired objectives of a given therapy session are met.
- the system 10 can include one or more subcutaneous access devices 94 , which are specially designed to accommodate high flow and frequent cannulation.
- a dual access arrangement requires two devices 94 , whereas a single access arrangement requires but a single device 94 .
- the connectors 64 and 74 of the inlet tube 62 and the outlet tube 72 comprise inlet and outlet cannulas.
- the cannulas are greater than about 18 gauge, and thereby capable of sustaining high flow rates to and from the patient's peritoneal cavity 20 .
- the connector 84 of the connector tube 82 comprises a single cannula.
- the cannula connectors are inserted into the access devices 94 .
- Each device 94 is implanted subcutaneously for repeated access by the cannula, which is passed into the device 94 percutaneously through the skin.
- the access device 94 can be constructed in various ways. In the illustrated embodiment (see FIGS. 3 and 4), the device 94 is generally constructed in the manner disclosed in pending U.S. patent application Ser. No. 08/724,948, filed Nov. 20, 1996, and entitled “Subcutaneously Implanted Cannula and Method for Arterial Access.”
- the device 94 includes a housing 210 carrying a valve assembly 212 .
- the valve assembly 212 comprises fixed valve member 214 and a shuttle valve member 216 .
- the shuttle valve member 216 is movable relative to the fixed valve member 214 between opened and closed positions. In the opened position (shown in FIG. 4), the shuttle valve member 216 is spaced away from the fixed valve member 214 , forming a valve passage 218 between them. In the closed position (shown in FIG. 3), the shuttle valve member 216 contacts or is in a close adjacent relationship with the fixed valve member 214 , which closes the valve passage 218 . A spring 220 normally biases the shuttle valve member 216 toward the closed position, shown in FIG. 3.
- the device 94 also includes an access passage 222 .
- the access passage 222 opens into the interior of the housing 210 through a port 224 .
- the access passage 222 generally extends perpendicular to the valve passage 218 .
- a flexible tube 226 is secured to the access passage 222 inside the housing 210 .
- the tube 226 extends from the access passage 222 and bends to pass through the valve passage 218 .
- the tube 226 extends beyond the housing 210 and, when implanted with the device 94 , communicates with the peritoneal cavity 20 .
- valve assembly 212 pinches the tube 226 between the fixed and movable valve members 214 and 216 , thereby blocking fluid flow through the tube 226 .
- An array of balls 228 rest in a circular channel 230 formed in the access passage 222 near the access port 224 .
- the circular channel 230 allows movement of the balls 228 along a formed cam surface 232 radially of and axially along the access passage 222 . Carried with the circular channel 230 , the balls 228 rest against the shuttle valve member 216 .
- the spring 220 which biases the shuttle valve member 216 toward the closed position, also normally urges the balls 228 along the cam surface 232 out into mutually facing contact within the access passage 222 near the access port 224 .
- the surface contact of the balls 228 in this position occurs generally along the center line of the access passage 222 and port 224 .
- a cannula connector C when passed through the access port 224 and toward the access passage 222 , breaks the surface contact between the balls 228 .
- Continued passage of the cannula connector C between the separated balls 228 and into the access passage 222 causes the balls to move along the cam surface 232 outward of and axially along the passage 222 away from the access port 224 . Movement of the balls 228 in this path presses against the shuttle valve member 216 .
- the cannula connector C transmits through the balls 228 a counter force to the biasing spring 220 , which overcomes the spring bias. As a result, the shuttle valve member 216 is moved away from the fixed valve member 214 , opening the valve passage 218 , as FIG. 4 shows. The tube 226 , no longer pinched, opens. Fluid flow through the cannula connector C is directed through the tube 226 to and from the peritoneal cavity 20 .
- the fluid source 40 can provide regeneration solution in a batch process.
- the fluid source 40 includes a flexible or rigid source container 96 .
- the source container 96 contains an aliquot of purified water from the water treatment module 42 or another source. The aliquot is sufficient to supply regeneration solution for an entire therapy session.
- Appropriate electrolytes are added to the purified water in the source container 96 . This combination forms the regeneration solution.
- the appropriate electrolytes can be bicarbonate buffer based or lactate buffer based.
- the appropriate concentration of electrolytes are enclosed within the source container 96 in a smaller bag 98 .
- the bag 98 is made of semi-permeable material.
- the electrolytes diffuse through the smaller bag 98 into the water, making a homogeneous solution.
- the concentrated electrolytes are introduced in powdered or liquid form to the purified water in the source container 96 .
- the regeneration fluid module 44 draws solution from the source container 96 .
- the module 44 verifies the contents of the solution for safety and heats the solution to body temperature.
- the module 44 then circulates the regeneration solution to the regeneration side 30 of the membrane device 22 , through an inlet line 114 to the port 36 , using a pump 100 .
- the regeneration solution can be passed through a sterilizing filter 102 prior to entering the regeneration side 30 of the membrane device 22 .
- a fluid return line 104 communicating with the outlet port 38 on the regeneration side 30 of the membrane device 22 can communicate, via the waste module 46 , directly with the drain 56 .
- the fluid return line 104 can be connected to a waste bag 106 , which can itself comprise the source container from the previous treatment session.
- the fluid return line 104 can be connected to the source container 96 , forming a re-circulation loop 128 .
- the returning used fluid can be separated from the fresh fluid in the source container 96 by a temperature boundary layer, or by a membrane in the source container 96 .
- the fluid source 40 can also provide regeneration solution in a continuous flow process.
- the water treatment module 42 supplies purified water to the regeneration solution module 44 on a continuous or on-demand basis.
- the regeneration solution module 44 dispenses the appropriate concentrated electrolyte solution from a source 130 to the purified water to make regeneration solution.
- the appropriate electrolytes can be bicarbonate buffer based or lactate buffer based.
- the regeneration solution module 44 verifies the content of the solution for safety and heats the solution to body temperature.
- the regeneration solution module 44 supplies the solution continuously through the regeneration side 30 of the membrane device 22 , through the inlet line 114 to the inlet port 36 , using the pump 100 .
- the regeneration solution module 44 can pass the solution through the sterilizing filter 102 prior to entering the regeneration side 30 of the membrane device 22 .
- the fluid return line 104 coupled to the outlet port 38 of the regeneration side 30 of the membrane device 22 , can be connected to a waste container 106 or directly to a drain 56 through the waste module 46 .
- peritoneal dialysis it is desirable to maintain, at least partially, a normal physiologic fluid and electrolytic balance in the patient.
- an ultrafiltration function is also performed during peritoneal dialysis, by which the overall fluid level of the individual is decreased.
- the cycler 14 can include a fluid balancing module 108 (see FIG. 7).
- the fluid balancing module 108 includes non-invasive fluid flow rate sensing devices 110 and 112 in the inlet line 114 and the return line 104 of the regeneration side 30 of the membrane device 22 .
- the fluid balancing module 108 also includes a flow restrictor 116 located in the return line 104 .
- the flow restrictor 116 comprising e.g., a stepper-driven pressure clamp, which pinches the outlet line 104 to control its flow resistance.
- the controller 16 monitors the flow rates sensed by the sensing devices 110 and 112 .
- the controller 16 operates the pump 100 and/or the flow restrictor 116 to maintain a zero differential in flow rates at the inlet and outlet of the regeneration side 30 of the membrane device 22 . In this way, fluid balance is maintained as the dialysis solution is regenerated.
- an outlet pump can be placed in the return line 104 , which can be operated in tandem with the inlet pump 100 to achieve fluid balance, without use of in-line pressure sensing.
- Other flow control devices in the inlet line 114 and return line 104 can be used to achieve a fluid balance between fluid entering and leaving the regeneration side 30 of the membrane device.
- an outlet pump can be placed in the return line 104 , which can be operated in tandem with the inlet pump 100 to achieve fluid balance, without use of in-line pressure sensing.
- Other flow control devices in the inlet line 114 and return line 104 can be used to achieve a fluid balance between fluid entering and leaving the regeneration side 30 of the membrane device 24 .
- Fluid balancing can also be achieved in a batch flow arrangement, like that shown in FIG. 5.
- a pump may be placed in-line in the re-circulation loop 128 .
- the pump is operated in tandem with the pump 100 to achieve fluid balance in the source container 98 .
- a pump can be placed in-line in the return line 104 in the same manner shown in FIG. 7.
- the cycler 14 can also include a fluid removal module 118 (see FIG. 7).
- the fluid removal module 118 includes a fluid removal line 120 and an in-line pump 122 upstream of the flow rate sensor 112 in the outlet line 104 .
- the pump 122 draws additional fluid across the membrane 26 from the dialysis solution, thereby reducing the overall fluid level of the patient.
- the fluid removal module 118 includes means 124 for monitoring the volume of excess fluid removed.
- the means 124 can provide a fixed volume measurement chamber, a valve and timing device, or a container with a weight sensing device.
- a comparable ultrafiltration function can likewise be achieved in the same manner in the batch flow arrangement shown in FIG. 5.
- the portions of the set 12 , through which peritoneal dialysis solution flows from and to the patient's peritoneal cavity 20 , can be removed from the cycler 14 and disposed of following each treatment.
- the tubes through which the regeneration solution flows during the procedure can also be disposed of after treatment.
- the fluid source 40 and associated tubes coupled to it can be cleaned and disinfected following each treatment for reuse.
- the cleaning and disinfection can be accomplished by flowing heated water, e.g., at 80° C., for, e.g., 1 hour through the fluid source 40 and associated tubes.
- the cleaning and disinfection can be accomplished by adding chemicals to water conducted through the fluid source 40 and associated tubes, followed by a water rinse and disinfectant and residual testing.
- the portions of the set 12 through which peritoneal dialysis solution flows from and to the patient's peritoneal cavity 20 can themselves be cleaned and disinfected for reuse, along with or independent of the fluid source 40 and associated tubes coupled to it.
- the cleaning and disinfection can be accomplished by connecting the patient connectors 74 and 84 together and circulating hot water (e.g., 80° C.) for, e.g., 1 hour.
- hot water e.g. 80° C.
- the remaining electrolytes in the patient side 28 of the fluid pathway will cross the membrane 26 into the water on the regeneration side 30 . Circulating hot water through the fluid source 40 and associated tubes on the regeneration side 30 will bring the entire set to a cleaning and disinfecting temperature.
- the regeneration solution side is flushed to remove pyrogenic material.
- the patient side 28 is likewise flushed with fresh, bagged sterile peritoneal dialysis solution to remove pyrogenic material and to make ready for the next treatment.
- the membrane device 22 in the patient side 28 and the filter 102 in the regeneration side 30 are each pressure tested to determine proper function following heat disinfection.
- tubing serving the patient side 28 of the membrane device 22 can be removed and disposed of following the cleaning and disinfection process, and replaced with new components.
- a high level disinfectant comprising chemical additives can be circulated through the tubing serving the membrane device 22 or fluid source 40 .
- the disinfectant can be contained in a disinfection container source 132 coupled to the regeneration module 126 (see FIG. 7).
- the disinfectant in the source 132 is mixed or proportioned into the solution as it is conveyed from the regeneration module 126 .
- the patient connectors 74 and 84 can be inserted into a shunt container 126 , to dispense the disinfectant through the patient side 28 of the membrane device 22 and associated tubes.
- the fluid source 40 and associated tubing is disinfected and then rinsed out by purified water, and tested for disinfectant residue.
- the patient side 28 tubes are flushed are flushed with new, bagged sterile dialysis solution to flush out pyrogenic material and tested for removal of the chemical agents, and to make the system 10 ready for the next treatment.
Landscapes
- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Heart & Thoracic Surgery (AREA)
- Emergency Medicine (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
Peritoneal dialysis is performed by circulating peritoneal dialysis solution through a peritoneal cavity by conveying peritoneal dialysis solution through an inlet branch into the peritoneal cavity and by withdrawing peritoneal dialysis solution through an outlet branch from the peritoneal cavity. Peritoneal dialysis solution in the outlet branch is conveyed along a first side of a porous membrane while conveying a regeneration solution containing at least one regenerating agent along a second side of the porous membrane. The membrane is configured to transport the regenerating agent into the peritoneal dialysis solution while transporting waste from the peritoneal dialysis solution into the regeneration solution, thereby creating a regenerated peritoneal dialysis solution. The regenerated peritoneal dialysis solution is circulated through the inlet branch into the peritoneal cavity.
Description
- This application is a continuation-in-part of copending United States Provisional Patent Application Ser. No. 60/121,733, filed Feb. 26, 1999, and entitled “Flow-Through Peritoneal Dialysis Systems and Methods with On-Line Dialysis Solution Regeneration,” which is incorporated herein by reference.
- The invention relates to systems and methods for performing peritoneal dialysis.
- Peritoneal Dialysis (PD) periodically infuses sterile aqueous solution into the peritoneal cavity. This solution is called peritoneal dialysis solution, or dialysate. Diffusion and osmosis exchanges take place between the solution and the bloodstream across the natural body membranes. These exchanges remove the waste products that the kidneys normally excrete. The waste products typically consist of solutes like sodium and chloride ions, and the other compounds normally excreted through the kidneys like urea, creatinine, and water. The diffusion of water across the peritoneal membrane during dialysis is called ultrafiltration.
- Conventional peritoneal dialysis solutions include dextrose in concentrations sufficient to generate the necessary osmotic pressure to remove water from the patient through ultrafiltration.
- Continuous Ambulatory Peritoneal Dialysis (CAPD) is a popular form of PD. A patient performs CAPD manually about four times a day. During CAPD, the patient drains spent peritoneal dialysis solution from his/her peritoneal cavity. The patient then infuses fresh peritoneal dialysis solution into his/her peritoneal cavity. This drain and fill procedure usually takes about 1 hour.
- Automated Peritoneal Dialysis (APD) is another popular form of PD. APD uses a machine, called a cycler, to automatically infuse, dwell, and drain peritoneal dialysis solution to and from the patient's peritoneal cavity. APD is particularly attractive to a PD patient, because it can be performed at night while the patient is asleep. This frees the patient from the day-to-day demands of CAPD during his/her waking and working hours.
- APD offers flexibility and quality of life enhancements to a person requiring dialysis. APD can free the patient from the fatigue and inconvenience that the day to day practice of CAPD represents to some individuals. APD can give back to the patient his or her waking and working hours free of the need to conduct dialysis exchanges.
- Still, CAPD and APD as practiced today require the use of bagged solutions, which are expensive and difficult to handle and connect. Bagged solutions also do not permit the use of bicarbonate buffering solutions due to sterilization issues. The complexity and size of past machines and associated disposables for various APD modalities have dampened widespread patient acceptance of APD as an alternative to manual peritoneal dialysis methods.
- The invention provides systems and methods for conducting peritoneal dialysis.
- One aspect of the invention provides a system for conducting peritoneal dialysis. The system comprises a pumping assembly to circulate peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis. The pumping assembly includes an inlet branch to convey peritoneal dialysis solution into the peritoneal cavity and an outlet branch to withdraw peritoneal dialysis solution from the peritoneal cavity. The system also includes a regeneration assembly coupled in-line between the inlet and outlet branches. The regeneration assembly includes a source of a regeneration solution that carries at least one agent for regenerating spent peritoneal dialysis solution. The regenerating agent can include, e.g., an electrolyte and a buffering agent. The regeneration assembly also includes a porous membrane having a first side and a second side. The pumping assembly circulates peritoneal dialysis solution along the first side of the porous membrane from the outlet branch to the inlet branch. The regeneration solution is circulated along the second side of the porous membrane. The porous membrane is configured to transport waste from spent peritoneal dialysis solution into the regeneration solution and to transport the regenerating agent from the regeneration solution into spent peritoneal dialysis solution. The transport can occur, e.g., by diffusion, convection, or both. The regeneration assembly thereby operates to create from peritoneal dialysis solution in the outlet branch, a regenerated dialysis solution for conveyance through the inlet branch into the peritoneal cavity.
- The source of regeneration solution can draw water from a source of water, which can comprise, e.g., running tap water. In one embodiment, the source of regeneration solution includes a device to treat water drawn from the source of water, as well as a device to mix the at least one regenerating agent with water drawn from the source of water.
- The source of regeneration solution can alternatively include a container holding a volume of water in which the at least one regenerating agent is mixed. In one embodiment, the source of regeneration solution includes a first container holding a volume of water and a second container that holds the at least one regenerating agent. The second container is located within the first container. The second container includes a wall material that, when contacted by water, transports the at least one regenerating agent into the water, thereby forming the regeneration solution.
- In one embodiment, the regeneration assembly includes a device to heat the regeneration solution before circulation along the second side of the porous membrane.
- In one embodiment, the inlet branch communicates with a first access device providing access to the peritoneal cavity, and the outlet branch communicates a second access device providing access to the peritoneal cavity independent of the access provided by the first device. In this arrangement, the pumping assembly can include a controller that withdraws peritoneal dialysis solution through the second access device into the regeneration assembly while conveying regenerated peritoneal dialysis solution from the regeneration device into the peritoneal cavity through the first access device. At least one of the first and second access devices can comprise, e.g., a subcutaneous access port.
- In one embodiment, the inlet and outlet branches jointly communicate with a single access device that provides common access to the peritoneal cavity. In this arrangement, the pumping assembly can include a controller operating in a draw mode, to withdraw peritoneal dialysis solution from the peritoneal cavity through the single access device into the regeneration assembly, and a return mode, to convey regenerated peritoneal dialysis solution into the peritoneal cavity through the single access device. The single access device comprises, e.g., a subcutaneous access port.
- In one embodiment, the regeneration assembly includes a fluid balancing module to maintain a volumetric balance between waste and regenerating agent transported by the porous membrane.
- In one embodiment, the regeneration assembly includes an ultrafiltration module to selectively transport a preselected greater volume of waste than regenerating agent.
- In one embodiment, the pumping assembly can accommodate circulation of a cleaning or disinfecting agent through the inlet and outlet branches, bypassing the peritoneal cavity. The regeneration assembly can also accommodate circulation of a cleaning or disinfecting agent along the first and second sides of the porous membrane.
- Another aspect of the invention provides a method for conducting peritoneal dialysis. The method (i) circulates peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis by conveying peritoneal dialysis solution through an inlet branch into the peritoneal cavity and by withdrawing peritoneal dialysis solution through an outlet branch from the peritoneal cavity. During at least a portion of step (i), the method (ii) conveys peritoneal dialysis solution in the outlet branch along a first side of a porous membrane while conveying a regeneration solution containing at least one regenerating agent along a second side of the porous membrane. The membrane is configured to transport the regenerating agent into the peritoneal dialysis solution while transporting waste from the peritoneal dialysis solution into the regeneration solution, thereby creating a regenerated peritoneal dialysis solution. During at least a portion of step (i), the method (iii) circulates the regenerated peritoneal dialysis solution through the inlet branch into the peritoneal cavity.
- The steps (ii), and (iii) can be performed simultaneously or sequentially.
- During step (ii), a prescribed volumetric balance can be maintained between waste and regenerating agent transported by the porous membrane to achieve fluid balancing. Also during step (ii), a preselected greater volume of waste than regenerating agent cen be selectively transported by the porous membrane to achieve ultrafiltration. $$
- Other features and advantages of the inventions are set forth in the following specification and attached drawings.
- FIG. 1 is a schematic view of a system for conducting flow-through peritoneal dialysis, showing a dual access with the peritoneal cavity;
- FIG. 2 is a schematic view of a system for conducting flow-through peritoneal dialysis, showing a single access with the peritoneal cavity;
- FIG. 3 is a side section view of a subcutaneous peritoneal cavity access device, showing the associated valve assembly in a closed condition;
- FIG. 4 is a side section view of the subcutaneous peritoneal cavity access device shown in FIG. 3, showing the associated valve assembly in a closed condition;
- FIG. 5 is a schematic view of a system like that shown in FIG. 1, in which the regeneration solution is supplied in a batch process;
- FIG. 6 is a schematic view of a system like that shown in FIG. 1, in which the regeneration solution is supplied in a continuous process; and
- FIG. 7 is a schematic view of the regeneration solution module like that shown in FIG. 1, which also includes fluid balancing and fluid removal capabilities.
- The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
- I. System Overview
- FIG. 1 shows a
system 10 for conducting flow-through peritoneal dialysis, which embodies the features of the invention. Thesystem 10 includes a peritoneal dialysis solution flow set 12 that is connected to anaccess device 18. Theaccess device 18 establishes communication between thesystem 10 and theperitoneal cavity 20 of a patient. - The
system 10 also includes acycler 14. Thecycler 14 interacts with the flow set 12, to pump peritoneal dialysis solution into and out of the patient'speritoneal cavity 20. - The
system 10 also includes acontroller 16. Thecontroller 16 governs the interaction between theset 12 and thecycler 14, to perform a selected flow-through peritoneal dialysis procedure. - The flow set12 includes an in-
line membrane device 22. Themembrane device 22 includes ahousing 24, which encloses asemipermeable membrane 26. Themembrane 26 can have different geometries. In the illustrated embodiment, themembrane 26 comprises a bundle of hollow fibers, through which peritoneal dialysis fluid drawn from theperitoneal cavity 20 of the patient flows. - The
membrane 26 compartmentalizes thechamber 24 into apatient side 28 and aregeneration side 30. In the illustrated embodiment, thepatient side 28 comprises the bores of the bundled hollow fibers, and theregeneration side 30 comprises the interior space surrounding the bundled hollow fibers. Aninlet port 32 and anoutlet port 34 convey dialysis solution into and out of thepatient side 28 of the chamber 24 (i.e., into and out of the bores of the hollow fibers). Aninlet port 36 andoutlet port 38 convey regeneration solution into and out of theregeneration side 30 ofchamber 24. - The
set 12 circulates peritoneal dialysis solution, transported from the patient'speritoneal cavity 20, along thepatient side 28 of themembrane 26. Theset 12 also circulates a regeneration solution containing electrolytes and/or bicarbonate buffering materials along theregeneration side 30 of themembrane 26. Thecycler 14 creates and supplies the regeneration solution, as will be described in detail later. - The pores of the
membrane 26 are sized to pass, by diffusion and convection, waste and uremic toxins from thepatient side 28 to theregeneration side 30. The pores of themembrane 26 are also sized to pass, by the same transport mechanisms, electrolytes and bicarbonate buffering materials from theregeneration side 30 to thepatient side 28. - The in-
line membrane device 22 thereby makes possible the continuous, on-line regeneration of peritoneal dialysis solution circulated in theset 12. - The
cycler 14 includes afluid source 40. In the embodiment shown in FIG. 1, thefluid source 40 comprises awater treatment module 42, aregeneration solution module 44, and awaste module 46. - The
water treatment module 42 receives water from a household water supply and processes the water, using e.,g., filtration, or absorption, or filtration and absorption, or reverse osmosis (with or without pre-filtration and/or absorption), or de-ionization (with or without pre-filtration and/or absorption), or reverse osmosis and de-ionization (with or without pre-filtration and/or absorption). By such processing, thewater treatment module 42 creates water substantially free of pyrogens and microorganisms. - The
regeneration solution module 44 receives processed water from thewater treatment module 42. Theregeneration solution module 44 mixes electrolytes and/or buffering agents with the processed water to create the regeneration solution. Themodule 44 verifies the make up of the solution and heats the solution to body temperature, for delivery to theregeneration side 30 of themembrane device 22. - The
waste module 46 directs system drain and waste water from theregeneration side 30 of themembrane device 22 to adrain 56 or other selected receptacle. - The
fluid source 40 of thecycler 14 obviates the need for bagged solutions, except for initially priming theset 12 prior to conducting a flow-through peritoneal dialysis procedure. Thefluid source 40 makes possible the continuous, on-line regeneration of peritoneal dialysis solution, which theset 12 circulates from and into the patient'speritoneal cavity 20. - The
processing controller 16 can comprise a stand-alone micro-processor controlled module or a mechanically and /or electrically controlled module linked to thecycler 14. In the illustrated embodiment, however, thecycler 14 andcontroller 16 are located within acommon housing 48. Thehousing 48 presents a compact footprint, suited for operation upon a table top or other relatively small surface normally found in the home. - In the illustrated embodiment, the
controller 16 also includes aninteractive user interface 50. Theinterface 50 comprises some form of adisplay 52, which can be analog or digital, and some form of apatient input device 54, such as knobs, dials, switches, keyboard or a touch screen on thedisplay 52. Theinterface 50 can e.g., present on thedisplay 52 the current status of thecycler 14, or prompt the user to input commands and information, or receive data from the various sensors and other components of thecycler 14, record the data in memory, or control the operation of the active components of the cycler 14 (such as valves, pumps, heaters, etc.), or alert the patient to abnormal or failure conditions in thecycler 14 with alarms or other indicators, or any or all of these functions. Additionally, theinterface 50 can be linked, e.g., by modem, to a central monitoring station or a central data collection site. - The
set 12 can be a single use, disposable item, or it can, with cleaning and disinfection, be reusable. This aspect with be described in greater detail later. - In use, the
cycler 14 draws peritoneal dialysis solution from the patient'speritoneal cavity 20, regenerates the dialysis solution, and returns the regenerated dialysis solution to the patient'speritoneal cavity 20, in a continuous or semi-continuous, extracoporeal path. The constant or semi-constant flow of peritoneal dialysis solution through theperitoneal cavity 20 provides sustained, high clearance of waste and toxins, which are conveyed to thedrain 56. The on-line regeneration of dialysis solution provides lower costs and requires less manipulation and set up than systems relying upon the connection and disconnection of bagged solutions. - II. Flow-Through Peritoneal Dialysis Modalities
- The
system 10 is particularly well suited to perform flow-through peritoneal dialysis (FTPD). For this reason, the use of thesystem 10 to perform various modalities of FTPD will be described in detail. - (A) Dual Access to the Peritoneal Cavity
- In the embodiment shown in FIG. 1, the
access device 18 provides dual access, having adedicated inlet 58 for conveying solution into theperitoneal cavity 20 and adedicated outlet 60 for conveying solution from theperitoneal cavity 20. Dual access provides continuous flow into and out of theperitoneal cavity 20. - Dual access can be provided, e.g., by a two indwelling catheters, a dual lumen, indwelling catheter, or two subcutaneous access devices. Further details of a preferred subcutaneous access device will be provided later.
- In this arrangement, the
set 12 includes aflexible inlet tube 62 with aconnector 64 that connects to theperitoneal cavity outlet 60. Theinlet tube 62 also is also connected to theinlet port 32 on thepatient side 28 of themembrane device 22, to convey dialysis solution across thepatient side 28 of themembrane 26. - The
cycler 14 includes aninlet pump 66. In the illustrated embodiment, theinlet pump 66 comprises a peristaltic pump. Thepump 66 includesrotating rollers 68 driven by a motor, e.g., a brushless D.C. motor. Therollers 68, in succession, press against and pinch theflexible inlet tube 62 against apump race 70, thereby urging liquid flow from theperitoneal cavity 20 through theinlet tube 62 across thepatient side 28 of themembrane device 22 in known peristaltic fashion. Of course, other types of noninvasive pumps can be used, provided that pump speed can be monitored and controlled. - The
set 12 further includes anoutlet tube 72, which is coupled to theoutlet port 34 of thepatient side 28 ofmembrane device 22. Theoutlet tube 72 conveys regenerated dialysis solution from thepatient side 28 of themembrane 26. Theoutlet tube 72 carries aconnector 74 that couples to theperitoneal cavity inlet 58, to further convey the regenerated dialysis solution into the patient'speritoneal cavity 20. - The
cycler 14 also includes twononinvasive pressure sensors sensors inlet tube 62 and theoutlet tube 72. Thecontroller 16 analyzes the sensed pressures and regulates theinlet pump 66 to maintain the pressure in theoutlet tube 72 within a predetermined safe range. Thecontroller 16 also terminates operation of theinlet pump 66 if sensed pressure in theinlet tube 62 falls outside a predetermined range. - The
cycler 14 further includes a noninvasivefluid intake valve 80. Thecontroller 16 closes theintake valve 80, to prevent the supply of dialysis solution to theperitoneal cavity 20, should a predetermined alarm condition arise. - (B) Single Access to the Peritoneal Cavity
- In the embodiment shown in FIG. 2, the
access device 18 provides a single access through a single indwelling catheter or a single subcutaneous access device. The single access arrangement provides semi-continuous flow of dialysis solution into and out of theperitoneal cavity 20 in a succession of draw modes and return modes. The quick cycling of draw and return modes provides virtually the same results as a continuous flow-through procedure, as just described. - In this arrangement, the
set 12 includes aconnector tube 82 with aconnector 84 that connects to thesingle access device 18. Theconnector tube 82 includes a y-connector 86, to which theinlet tube 62 and theoutlet tube 72 are connected. Theinlet tube 62 is connected to theinlet port 32 of themembrane device 22. Theoutlet tube 72 is coupled to theoutlet port 34 of themembrane device 22. - In this arrangement, the
outlet tube 72 includes an in-line,non-vented reservoir 88. Thereservoir 88 receives regenerated dialysis solution from themembrane device 22. Asensor 90 monitors fluid pressure in thereservoir 88, which increases as solution fills thereservoir 88 and decreases as solution exits thereservoir 88. - The
cycler 14 includes in theoutlet tube 72 the same, previously described noninvasivefluid intake valve 80. In the arrangement, thecycler 14 also includes a noninvasivefluid removal valve 92 in theinlet tube 62. - The
controller 16 toggles thefluid intake valve 80 and thefluid removal valve 92 between opposing opened and closed states, to affect successive fluid draw and fluid return modes. - In the fluid draw mode, the
fluid removal valve 92 is opened and thefluid intake valve 80 is closed. Theinlet pump 66 conveys dialysis solution through theinlet tube 62 from theperitoneal cavity 20 into themembrane device 22. Theoutlet tube 72 conveys regenerated dialysis solution from themembrane device 22 to thereservoir 88. - When a predetermined pressure condition exists in the
reservoir 88, as sensed by thesenor 90, thecontroller 16 switches to the fluid return mode. Theinlet pump 66 is stopped. Thefluid intake valve 80 is opened, and thefluid removal valve 92 is closed. Regenerated dialysis solution flows by pressure from thereservoir 88 through theoutlet tube 72 and into theperitoneal cavity 20. The return mode terminates when the pressure condition in thereservoir 88, as sensed by thesensor 90, drops below a predetermined threshold. - The
controller 16 then switches to another fluid draw mode. Thecontroller 16 cycles between successive fluid draw and return modes until the desired objectives of a given therapy session are met. - (C) Subcutaneous Access Device
- The
system 10 can include one or moresubcutaneous access devices 94, which are specially designed to accommodate high flow and frequent cannulation. A dual access arrangement requires twodevices 94, whereas a single access arrangement requires but asingle device 94. - In the dual access arrangement, the
connectors inlet tube 62 and theoutlet tube 72 comprise inlet and outlet cannulas. The cannulas are greater than about 18 gauge, and thereby capable of sustaining high flow rates to and from the patient'speritoneal cavity 20. In a single access arrangement, theconnector 84 of theconnector tube 82 comprises a single cannula. - The cannula connectors, in turn, are inserted into the
access devices 94. Eachdevice 94 is implanted subcutaneously for repeated access by the cannula, which is passed into thedevice 94 percutaneously through the skin. - The
access device 94 can be constructed in various ways. In the illustrated embodiment (see FIGS. 3 and 4), thedevice 94 is generally constructed in the manner disclosed in pending U.S. patent application Ser. No. 08/724,948, filed Nov. 20, 1996, and entitled “Subcutaneously Implanted Cannula and Method for Arterial Access.” - As shown in FIGS. 3 and 4, the
device 94 includes ahousing 210 carrying avalve assembly 212. Thevalve assembly 212 comprises fixedvalve member 214 and ashuttle valve member 216. - The
shuttle valve member 216 is movable relative to the fixedvalve member 214 between opened and closed positions. In the opened position (shown in FIG. 4), theshuttle valve member 216 is spaced away from the fixedvalve member 214, forming avalve passage 218 between them. In the closed position (shown in FIG. 3), theshuttle valve member 216 contacts or is in a close adjacent relationship with the fixedvalve member 214, which closes thevalve passage 218. Aspring 220 normally biases theshuttle valve member 216 toward the closed position, shown in FIG. 3. - The
device 94 also includes anaccess passage 222. Theaccess passage 222 opens into the interior of thehousing 210 through aport 224. Theaccess passage 222 generally extends perpendicular to thevalve passage 218. - A
flexible tube 226 is secured to theaccess passage 222 inside thehousing 210. Thetube 226 extends from theaccess passage 222 and bends to pass through thevalve passage 218. Thetube 226 extends beyond thehousing 210 and, when implanted with thedevice 94, communicates with theperitoneal cavity 20. - As FIG. 3 shows, the normally closed position of the
valve assembly 212 pinches thetube 226 between the fixed andmovable valve members tube 226. - An array of
balls 228 rest in acircular channel 230 formed in theaccess passage 222 near theaccess port 224. Thecircular channel 230 allows movement of theballs 228 along a formedcam surface 232 radially of and axially along theaccess passage 222. Carried with thecircular channel 230, theballs 228 rest against theshuttle valve member 216. - The
spring 220, which biases theshuttle valve member 216 toward the closed position, also normally urges theballs 228 along thecam surface 232 out into mutually facing contact within theaccess passage 222 near theaccess port 224. The surface contact of theballs 228 in this position occurs generally along the center line of theaccess passage 222 andport 224. - A cannula connector C, when passed through the
access port 224 and toward theaccess passage 222, breaks the surface contact between theballs 228. Continued passage of the cannula connector C between the separatedballs 228 and into theaccess passage 222 causes the balls to move along thecam surface 232 outward of and axially along thepassage 222 away from theaccess port 224. Movement of theballs 228 in this path presses against theshuttle valve member 216. - The cannula connector C transmits through the balls228 a counter force to the biasing
spring 220, which overcomes the spring bias. As a result, theshuttle valve member 216 is moved away from the fixedvalve member 214, opening thevalve passage 218, as FIG. 4 shows. Thetube 226, no longer pinched, opens. Fluid flow through the cannula connector C is directed through thetube 226 to and from theperitoneal cavity 20. - Movement of the cannula connector C out of the
access passage 222 relieves the counter force against theballs 228. With the cannula connector C free of theballs 228, the now unopposed biasing force of thespring 220 returns theballs 228 along thecam surface 232 axially toward theaccess port 224 and radially back into theaccess passage 222. At the same time, theshuttle valve member 216 is urged toward the closed position, closing thetube 226. - III. Supply of Regeneration Solution
- (A) Batch Process
- The
fluid source 40 can provide regeneration solution in a batch process. In this arrangement (see FIG. 5), thefluid source 40 includes a flexible orrigid source container 96. Thesource container 96 contains an aliquot of purified water from thewater treatment module 42 or another source. The aliquot is sufficient to supply regeneration solution for an entire therapy session. - Appropriate electrolytes are added to the purified water in the
source container 96. This combination forms the regeneration solution. The appropriate electrolytes can be bicarbonate buffer based or lactate buffer based. - In one embodiment, the appropriate concentration of electrolytes are enclosed within the
source container 96 in asmaller bag 98. Thebag 98 is made of semi-permeable material. When purified water is introduced into thesource container 96, the electrolytes diffuse through thesmaller bag 98 into the water, making a homogeneous solution. In another embodiment, the concentrated electrolytes are introduced in powdered or liquid form to the purified water in thesource container 96. - The
regeneration fluid module 44 draws solution from thesource container 96. Themodule 44 verifies the contents of the solution for safety and heats the solution to body temperature. Themodule 44 then circulates the regeneration solution to theregeneration side 30 of themembrane device 22, through aninlet line 114 to theport 36, using apump 100. - If desired, the regeneration solution can be passed through a sterilizing
filter 102 prior to entering theregeneration side 30 of themembrane device 22. - A
fluid return line 104 communicating with theoutlet port 38 on theregeneration side 30 of themembrane device 22 can communicate, via thewaste module 46, directly with thedrain 56. Alternatively, thefluid return line 104 can be connected to awaste bag 106, which can itself comprise the source container from the previous treatment session. - Still alternatively, the
fluid return line 104 can be connected to thesource container 96, forming are-circulation loop 128. The returning used fluid can be separated from the fresh fluid in thesource container 96 by a temperature boundary layer, or by a membrane in thesource container 96. - (B) Continuous Flow Process
- The
fluid source 40 can also provide regeneration solution in a continuous flow process. In this arrangement (see FIG. 6), thewater treatment module 42 supplies purified water to theregeneration solution module 44 on a continuous or on-demand basis. - In this arrangement, the
regeneration solution module 44 dispenses the appropriate concentrated electrolyte solution from asource 130 to the purified water to make regeneration solution. As before stated, the appropriate electrolytes can be bicarbonate buffer based or lactate buffer based. - The
regeneration solution module 44 verifies the content of the solution for safety and heats the solution to body temperature. Theregeneration solution module 44 supplies the solution continuously through theregeneration side 30 of themembrane device 22, through theinlet line 114 to theinlet port 36, using thepump 100. As before stated, theregeneration solution module 44 can pass the solution through the sterilizingfilter 102 prior to entering theregeneration side 30 of themembrane device 22. - In this arrangement, as in the batch arrangement, the
fluid return line 104, coupled to theoutlet port 38 of theregeneration side 30 of themembrane device 22, can be connected to awaste container 106 or directly to adrain 56 through thewaste module 46. - IV. Fluid Balancing and Removal
- During peritoneal dialysis, it is desirable to maintain, at least partially, a normal physiologic fluid and electrolytic balance in the patient. Usually, an ultrafiltration function is also performed during peritoneal dialysis, by which the overall fluid level of the individual is decreased.
- For these purposes, the
cycler 14 can include a fluid balancing module 108 (see FIG. 7). In the illustrated embodiment, thefluid balancing module 108 includes non-invasive fluid flowrate sensing devices inlet line 114 and thereturn line 104 of theregeneration side 30 of themembrane device 22. - The
fluid balancing module 108 also includes a flow restrictor 116 located in thereturn line 104. The flow restrictor 116 comprising e.g., a stepper-driven pressure clamp, which pinches theoutlet line 104 to control its flow resistance. - The
controller 16 monitors the flow rates sensed by thesensing devices controller 16 operates thepump 100 and/or the flow restrictor 116 to maintain a zero differential in flow rates at the inlet and outlet of theregeneration side 30 of themembrane device 22. In this way, fluid balance is maintained as the dialysis solution is regenerated. - Other forms of fluid balancing can be used. For example, an outlet pump can be placed in the
return line 104, which can be operated in tandem with theinlet pump 100 to achieve fluid balance, without use of in-line pressure sensing. Other flow control devices in theinlet line 114 and returnline 104 can be used to achieve a fluid balance between fluid entering and leaving theregeneration side 30 of the membrane device. - There are alternative ways to achieve fluid balancing in a continuous flow arrangement, like that shown in FIG. 7. For example, an outlet pump can be placed in the
return line 104, which can be operated in tandem with theinlet pump 100 to achieve fluid balance, without use of in-line pressure sensing. Other flow control devices in theinlet line 114 and returnline 104 can be used to achieve a fluid balance between fluid entering and leaving theregeneration side 30 of themembrane device 24. - Fluid balancing can also be achieved in a batch flow arrangement, like that shown in FIG. 5. For example, a pump may be placed in-line in the
re-circulation loop 128. The pump is operated in tandem with thepump 100 to achieve fluid balance in thesource container 98. Alternatively, without are-circulation loop 128, a pump can be placed in-line in thereturn line 104 in the same manner shown in FIG. 7. - To provide an ultrafiltration function, the
cycler 14 can also include a fluid removal module 118 (see FIG. 7). In the illustrated embodiment, thefluid removal module 118 includes afluid removal line 120 and an in-line pump 122 upstream of theflow rate sensor 112 in theoutlet line 104. Thepump 122 draws additional fluid across themembrane 26 from the dialysis solution, thereby reducing the overall fluid level of the patient. - In the illustrated embodiment, the
fluid removal module 118 includesmeans 124 for monitoring the volume of excess fluid removed. The means 124 can provide a fixed volume measurement chamber, a valve and timing device, or a container with a weight sensing device. - A comparable ultrafiltration function can likewise be achieved in the same manner in the batch flow arrangement shown in FIG. 5.
- V. Reuse
- (A) Reusing the Regeneration Solution Paths
- As before described, the portions of the
set 12, through which peritoneal dialysis solution flows from and to the patient'speritoneal cavity 20, can be removed from thecycler 14 and disposed of following each treatment. In this arrangement, the tubes through which the regeneration solution flows during the procedure can also be disposed of after treatment. - Alternatively, the
fluid source 40 and associated tubes coupled to it can be cleaned and disinfected following each treatment for reuse. In one embodiment, the cleaning and disinfection can be accomplished by flowing heated water, e.g., at 80° C., for, e.g., 1 hour through thefluid source 40 and associated tubes. In another embodiment, the cleaning and disinfection can be accomplished by adding chemicals to water conducted through thefluid source 40 and associated tubes, followed by a water rinse and disinfectant and residual testing. - (B) Reusing the Patient Side Solution Paths
- In an alternative embodiment, the portions of the
set 12 through which peritoneal dialysis solution flows from and to the patient'speritoneal cavity 20 can themselves be cleaned and disinfected for reuse, along with or independent of thefluid source 40 and associated tubes coupled to it. - In one embodiment, the cleaning and disinfection can be accomplished by connecting the
patient connectors patient side 28 of the fluid pathway will cross themembrane 26 into the water on theregeneration side 30. Circulating hot water through thefluid source 40 and associated tubes on theregeneration side 30 will bring the entire set to a cleaning and disinfecting temperature. After cooling, the regeneration solution side is flushed to remove pyrogenic material. Thepatient side 28 is likewise flushed with fresh, bagged sterile peritoneal dialysis solution to remove pyrogenic material and to make ready for the next treatment. - In one embodiment, the
membrane device 22 in thepatient side 28 and thefilter 102 in theregeneration side 30 are each pressure tested to determine proper function following heat disinfection. - As an alternative embodiment, the tubing serving the
patient side 28 of themembrane device 22 can be removed and disposed of following the cleaning and disinfection process, and replaced with new components. - In an alternative embodiment, a high level disinfectant comprising chemical additives can be circulated through the tubing serving the
membrane device 22 orfluid source 40. The disinfectant can be contained in adisinfection container source 132 coupled to the regeneration module 126 (see FIG. 7). The disinfectant in thesource 132 is mixed or proportioned into the solution as it is conveyed from theregeneration module 126. During this time, thepatient connectors shunt container 126, to dispense the disinfectant through thepatient side 28 of themembrane device 22 and associated tubes. - The
fluid source 40 and associated tubing is disinfected and then rinsed out by purified water, and tested for disinfectant residue. Thepatient side 28 tubes are flushed are flushed with new, bagged sterile dialysis solution to flush out pyrogenic material and tested for removal of the chemical agents, and to make thesystem 10 ready for the next treatment. - Various features of the invention are set forth in the following claims.
Claims (59)
1. A system for conducting peritoneal dialysis comprising
a pumping assembly to circulate peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis including a inlet branch to convey peritoneal dialysis solution into the peritoneal cavity and an outlet branch to withdraw peritoneal dialysis solution from the peritoneal cavity, and
a regeneration assembly coupled in-line between the inlet and outlet branches, the regeneration assembly including a source of a regeneration solution that carries at least one agent for regenerating spent peritoneal dialysis solution, and a porous membrane having a first side, along which peritoneal dialysis solution is circulated by the pumping assembly from the outlet branch to the inlet branch, and a second side, along which the regeneration solution is circulated, the porous membrane being configured to transport waste from spent peritoneal dialysis solution into the regeneration solution and to transport the regenerating agent from the regeneration solution into spent peritoneal dialysis solution, the regeneration assembly operating to create from peritoneal dialysis solution in the outlet branch, a regenerated dialysis solution for conveyance through the inlet branch into the peritoneal cavity.
2. A system according to
claim 1
wherein the regeneration assembly includes a pump to convey regeneration solution from the source along the second side of the porous membrane.
3. A system according to wherein the regeneration assembly includes a waste line to remove regeneration solution from the second side of the porous membrane.
claim 1
4. A system according to wherein the waste line communicates with a drain.
claim 3
5. A system according to
claim 3
wherein the waste line communicates with a waste-receiving container.
6. A system according to
claim 3
wherein the waste line communicates with the source of regeneration solution to recirculate at least a portion of the regeneration solution.
7. A system according to
claim 1
wherein the regenerating agent includes an electrolyte.
8. A system according to
claim 1
wherein the regenerating agent includes a buffering agent.
9. A system according to
claim 8
wherein the buffering agent comprises a bicarbonate buffering material.
10. A system according to
claim 8
wherein the buffering agent comprises a lactate buffering agent.
11. A system according to
claim 1
wherein the regenerating agent includes an electrolyte and a buffering agent.
12. A system according to
claim 11
wherein the buffering agent comprises a bicarbonate buffering material.
13. A system according to
claim 11
wherein the buffering agent comprises a lactate buffering agent.
14. A system according to
claim 1
wherein the source of regeneration solution draws water from a source of water.
15. A system according to
claim 14
wherein the source of water comprises tap water.
16. A system according to
claim 14
wherein the source of regeneration solution includes a device to treat water drawn from the source of water.
17. A system according to
claim 14
wherein the source of regeneration solution includes a device to mix the at least one regenerating agent with water drawn from the source of water.
18. A system according to
claim 1
wherein the source of regeneration solution draws water from a source of running water.
19. A system according to
claim 18
wherein the source of running water is tap water.
20. A system according to
claim 18
wherein the source of regeneration solution includes a device to treat water drawn from the source of the running water.
21. A system according to
claim 18
wherein the source of regeneration solution includes a device to mix the at least one regenerating agent with water drawn from the source of running water.
22. A system according to
claim 1
wherein the source of regeneration solution includes a container holding a volume of water in which the at least one regenerating agent is mixed.
23. A system according to
claim 1
wherein the source of regeneration solution includes a first container holding a volume of water and a second container that holds the at least one regenerating agent, the second container being located within the first container and including a wall material that, when contacted by water, transports the at least one regenerating agent into the water, thereby forming the regeneration solution.
24. A system according to
claim 1
wherein the regeneration assembly includes a device to heat the regeneration solution before circulation along the second side of the porous membrane.
25. A system according to
claim 1
wherein the regeneration assembly includes a sterilizing filter between the source of regeneration solution and the porous membrane.
26. A system according to
claim 1
wherein the porous membrane comprises a semipermeable membrane.
27. A system according to
claim 26
wherein the porous membrane comprises a bundle of hollow fibers each having an exterior, which comprises the second side of the porous membrane, and an interior lumen, which comprises the first side of the porous membrane.
28. A system according to
claim 1
wherein the porous membrane transports waste and the at least one regenerating agent by diffusion, convection, or both.
29. A system according to
claim 1
wherein the inlet branch communicates with a first access device providing access to the peritoneal cavity, and
wherein the outlet branch communicates a second access device providing access to the peritoneal cavity independent of the access provided by the first device.
30. A system according to
claim 29
wherein the pumping assembly includes a controller that withdraws peritoneal dialysis solution through the second access device into the regeneration assembly while conveying regenerated peritoneal dialysis solution from the regeneration device into the peritoneal cavity through the first access device.
31. A system according to
claim 29
wherein at least one of the first and second access devices comprises a subcutaneous access port.
32. A system according to
claim 1
wherein the inlet and outlet branches jointly communicate with a single access device that provides common access to the peritoneal cavity.
33. A system according to
claim 32
wherein the pumping assembly includes a controller operating in a draw mode, to withdraw peritoneal dialysis solution from the peritoneal cavity through the single access device into the regeneration assembly, and a return mode, to convey regenerated peritoneal dialysis solution into the peritoneal cavity through the single access device.
34. A system according to
claim 33
wherein the controller toggles between the draw mode and the return mode.
35. A system according to
claim 33
wherein the regeneration assembly includes a reservoir in the inlet branch to collect regenerated peritoneal dialysis solution during the draw mode.
36. A system according to
claim 35
wherein the regeneration assembly includes a sensor to sense presence of regenerated dialysis solution in the reservoir and to generate an output relating to volume of regenerated peritoneal dialysis solution present in the reservoir, and
wherein the controller toggles between the draw mode and return mode in response to the output.
37. A system according to
claim 32
wherein the single access device comprises a subcutaneous access port.
38. A system according to
claim 1
wherein the regeneration assembly includes a fluid balancing module to maintain a volumetric balance between waste and regenerating agent transported by the porous membrane.
39. A system according to
claim 1
wherein the regeneration assembly includes an ultrafiltration module to selectively transport a preselected greater volume of waste than regenerating agent.
40. A system according to
claim 1
wherein the pumping assembly accommodates circulation of a cleaning or disinfecting agent through the inlet and outlet branches, bypassing the peritoneal cavity.
41. A system according to
claim 1
wherein the regeneration assembly accommodates circulation of a cleaning or disinfecting agent along the first and second sides of the porous membrane.
42. A method for conducting peritoneal dialysis comprising steps of
(i) circulating peritoneal dialysis solution through a peritoneal cavity to perform peritoneal dialysis by conveying peritoneal dialysis solution through an inlet branch into the peritoneal cavity and by withdrawing peritoneal dialysis solution through an outlet branch from the peritoneal cavity,
(ii) during at least a portion of step (i), conveying peritoneal dialysis solution in the outlet branch along a first side of a porous membrane while conveying a regeneration solution containing at least one regenerating agent along a second side of the porous membrane, the membrane being configured to transport the regenerating agent into the peritoneal dialysis solution while transporting waste from the peritoneal dialysis solution into the regeneration solution, thereby creating a regenerated peritoneal dialysis solution, and
(iii) during at least a portion of step (i), circulating the regenerated peritoneal dialysis solution through the inlet branch into the peritoneal cavity.
43. A method according to
claim 42
wherein steps (ii), and (iii) are performed simultaneously.
44. A method according to
claim 42
wherein steps (ii) and (iii) are performed sequentially.
45. A method according to
claim 42
wherein, during step (ii), a prescribed volumetric balance is maintained between waste and regenerating agent transported by the porous membrane to achieve fluid balancing.
46. A method according to
claim 42
wherein, during step (ii), a preselected greater volume of waste than regenerating agent is selectively transported by the porous membrane to achieve ultrafiltration.
47. A method according to
claim 42
wherein, during step (ii), regeneration solution is removed from the second side of the porous membrane to a waste line.
48. A method according to
claim 42
wherein, during step (ii), water is drawn from a source of water to create the regeneration solution.
49. A method according to
claim 48
wherein the source of water is tap water.
50. A method according to
claim 48
wherein, during step (ii), water that is drawn from the source of water is treated.
51. A method according to
claim 48
wherein, during step (ii), the at least one regenerating agent is mixed with water drawn from the source of water.
52. A method according to
claim 48
wherein, during step (ii), water is drawn from a source of running water to create the regeneration solution.
53. A method according to
claim 52
wherein the source of running water is tap water.
54. A method according to
claim 52
wherein, during step (ii), water that is drawn from the source of running water is treated.
55. A method according to
claim 52
wherein, during step (ii), the at least one regenerating agent is mixed with water drawn from the source of running water.
56. A method according to
claim 42
wherein, during step (ii), the regeneration solution is heated before circulation along the second side of the porous membrane.
57. A method according to
claim 42
wherein, during step (ii), the regeneration solution is passed through a sterilizing filter before circulation along the second side of the porous membrane.
58. A method according to
claim 42
wherein, after completion of step (i), a cleaning or disinfecting agent is circulated through the inlet and outlet branches, bypassing the peritoneal cavity.
59. A method according to
claim 42
wherein, after completion of step (i), a cleaning or disinfecting agent is circulated along the first and second sides of the porous membrane.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/878,443 US20010027289A1 (en) | 1999-02-26 | 2001-06-12 | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12173399P | 1999-02-26 | 1999-02-26 | |
US09/512,132 US6254567B1 (en) | 1999-02-26 | 2000-02-23 | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration |
US09/878,443 US20010027289A1 (en) | 1999-02-26 | 2001-06-12 | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/512,132 Continuation US6254567B1 (en) | 1999-02-26 | 2000-02-23 | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration |
Publications (1)
Publication Number | Publication Date |
---|---|
US20010027289A1 true US20010027289A1 (en) | 2001-10-04 |
Family
ID=22398477
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/512,132 Expired - Fee Related US6254567B1 (en) | 1999-02-26 | 2000-02-23 | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration |
US09/878,443 Abandoned US20010027289A1 (en) | 1999-02-26 | 2001-06-12 | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/512,132 Expired - Fee Related US6254567B1 (en) | 1999-02-26 | 2000-02-23 | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration |
Country Status (3)
Country | Link |
---|---|
US (2) | US6254567B1 (en) |
AU (1) | AU3247300A (en) |
WO (1) | WO2000050143A1 (en) |
Cited By (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20040025693A1 (en) * | 2002-08-08 | 2004-02-12 | John Bedingfield | Gas venting device and a system and method for venting a gas from a liquid delivery system |
WO2004008826A3 (en) * | 2002-07-19 | 2004-05-13 | Baxter Int | Systems and methods for performing peritoneal dialysis |
JP2007509681A (en) * | 2003-10-28 | 2007-04-19 | スミス アンド ネフュー ピーエルシー | Wound purification device using heat |
US20070213653A1 (en) * | 2002-07-19 | 2007-09-13 | Baxter International Inc. | System including machine interface for pumping cassette-based therapies |
US20090318844A1 (en) * | 2003-11-03 | 2009-12-24 | Novashunt Ag | Implantable fluid management device for the removal of excess fluid |
US7867214B2 (en) | 2002-07-19 | 2011-01-11 | Baxter International Inc. | Systems and methods for performing peritoneal dialysis |
US7922911B2 (en) | 2002-07-19 | 2011-04-12 | Baxter International Inc. | Systems and methods for peritoneal dialysis |
US20110178455A1 (en) * | 2002-02-25 | 2011-07-21 | Burnett Daniel R | Implantable fluid management system for the removal of excess fluid |
US20150057602A1 (en) * | 2013-08-26 | 2015-02-26 | Roger Alan Mason | System and Method for Administering Peritoneal Dialysis |
US10646634B2 (en) | 2008-07-09 | 2020-05-12 | Baxter International Inc. | Dialysis system and disposable set |
US10918778B2 (en) | 2017-05-24 | 2021-02-16 | Sequana Medical Nv | Direct sodium removal method, solution and apparatus to reduce fluid overload in heart failure patients |
WO2022146706A1 (en) * | 2020-12-29 | 2022-07-07 | Baxter International Inc. | Peritoneal dialysis cycler having heat cleaning |
US11400193B2 (en) | 2008-08-28 | 2022-08-02 | Baxter International Inc. | In-line sensors for dialysis applications |
US11495334B2 (en) | 2015-06-25 | 2022-11-08 | Gambro Lundia Ab | Medical device system and method having a distributed database |
US11516183B2 (en) | 2016-12-21 | 2022-11-29 | Gambro Lundia Ab | Medical device system including information technology infrastructure having secure cluster domain supporting external domain |
US11559618B2 (en) | 2017-05-24 | 2023-01-24 | Sequana Medical Nv | Formulations and methods for direct sodium removal in patients having severe renal dysfunction |
US11793916B2 (en) | 2012-02-15 | 2023-10-24 | Sequana Medical Nv | Systems and methods for fluid management |
US11839712B2 (en) | 2004-08-18 | 2023-12-12 | Sequana Medical Nv | Implantable fluid management system for treating heart failure |
US11854697B2 (en) | 2016-08-26 | 2023-12-26 | Sequana Medical Nv | Systems and methods for managing and analyzing data generated by an implantable device |
Families Citing this family (174)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000107286A (en) * | 1998-10-07 | 2000-04-18 | Akira Sakai | Perfusion apparatus for peritoneal dialyzate and perfusion method |
US6497676B1 (en) | 2000-02-10 | 2002-12-24 | Baxter International | Method and apparatus for monitoring and controlling peritoneal dialysis therapy |
US6527735B1 (en) * | 2000-04-27 | 2003-03-04 | Renaltech International Llc | Method of peritoneal dialysis |
DE10042067A1 (en) * | 2000-08-26 | 2002-03-14 | Fresenius Medical Care De Gmbh | Peritoneal catheter and tube system arrangement has tubular portions for fluid-tightly connecting each lumen |
DK1399193T3 (en) * | 2001-02-16 | 2014-03-31 | Piedmont Renal Clinics P A | Automated peritoneal dialysis system and method of in-line sterilization of the dialysate |
US6808503B2 (en) | 2001-03-06 | 2004-10-26 | Baxter International Inc. | Automated system and method for pre-surgical blood donation and fluid replacement |
US6706008B2 (en) | 2001-03-06 | 2004-03-16 | Baxter International Inc. | Automated system and method for withdrawing compounds from blood |
US6582386B2 (en) | 2001-03-06 | 2003-06-24 | Baxter International Inc. | Multi-purpose, automated blood and fluid processing systems and methods |
US6884228B2 (en) | 2001-03-06 | 2005-04-26 | Baxter International Inc. | Automated system adaptable for use with different fluid circuits |
US7241272B2 (en) | 2001-11-13 | 2007-07-10 | Baxter International Inc. | Method and composition for removing uremic toxins in dialysis processes |
US20030114787A1 (en) * | 2001-12-13 | 2003-06-19 | Victor Gura | Wearable peritoneal dialysis system |
EP1485146B1 (en) * | 2002-02-25 | 2013-08-07 | Sequana Medical AG | Vesicular shunt for the drainage of excess fluid |
US6939111B2 (en) * | 2002-05-24 | 2005-09-06 | Baxter International Inc. | Method and apparatus for controlling medical fluid pressure |
US7153286B2 (en) | 2002-05-24 | 2006-12-26 | Baxter International Inc. | Automated dialysis system |
US7033539B2 (en) * | 2002-05-24 | 2006-04-25 | Baxter International Inc. | Graphical user interface for automated dialysis system |
US7175606B2 (en) | 2002-05-24 | 2007-02-13 | Baxter International Inc. | Disposable medical fluid unit having rigid frame |
AU2003237403A1 (en) * | 2002-06-06 | 2003-12-22 | Nxstage Medical, Inc. | Last-chance quality check and/or air/pyrogen filter for infusion systems |
US7846141B2 (en) | 2002-09-03 | 2010-12-07 | Bluesky Medical Group Incorporated | Reduced pressure treatment system |
GB0224986D0 (en) | 2002-10-28 | 2002-12-04 | Smith & Nephew | Apparatus |
CA2411569A1 (en) * | 2002-11-12 | 2004-05-12 | Ross E. Mantle | Medical device for the extravascular recirculation of fluid in body cavities at controlled temperature and pressure |
EP1592494B1 (en) * | 2003-01-07 | 2009-06-24 | NxStage Medical, Inc. | Batch filtration system for preparation of sterile replacement fluid for renal therapy |
US20080210606A1 (en) | 2004-01-07 | 2008-09-04 | Jeffrey Burbank | Filtration System Preparation of Fluids for Medical Applications |
US9700663B2 (en) * | 2005-01-07 | 2017-07-11 | Nxstage Medical, Inc. | Filtration system for preparation of fluids for medical applications |
WO2005042065A2 (en) | 2003-10-28 | 2005-05-12 | Baxter International Inc. | Improved priming, integrity and head height methods and apparatuses for medical fluid systems |
GB0325129D0 (en) | 2003-10-28 | 2003-12-03 | Smith & Nephew | Apparatus in situ |
GB0325120D0 (en) * | 2003-10-28 | 2003-12-03 | Smith & Nephew | Apparatus with actives |
GB0518804D0 (en) * | 2005-09-15 | 2005-10-26 | Smith & Nephew | Exudialysis tissue cleanser |
GB0325130D0 (en) * | 2003-10-28 | 2003-12-03 | Smith & Nephew | Apparatus with scaffold |
US8758313B2 (en) | 2003-10-28 | 2014-06-24 | Smith & Nephew Plc | Apparatus and method for wound cleansing with actives |
US11298453B2 (en) | 2003-10-28 | 2022-04-12 | Smith & Nephew Plc | Apparatus and method for wound cleansing with actives |
US8038639B2 (en) | 2004-11-04 | 2011-10-18 | Baxter International Inc. | Medical fluid system with flexible sheeting disposable unit |
US8029454B2 (en) | 2003-11-05 | 2011-10-04 | Baxter International Inc. | High convection home hemodialysis/hemofiltration and sorbent system |
US7744553B2 (en) * | 2003-12-16 | 2010-06-29 | Baxter International Inc. | Medical fluid therapy flow control systems and methods |
US7708724B2 (en) * | 2004-04-05 | 2010-05-04 | Blue Sky Medical Group Incorporated | Reduced pressure wound cupping treatment system |
US10058642B2 (en) | 2004-04-05 | 2018-08-28 | Bluesky Medical Group Incorporated | Reduced pressure treatment system |
US7776028B2 (en) | 2004-04-05 | 2010-08-17 | Bluesky Medical Group Incorporated | Adjustable overlay reduced pressure wound treatment system |
US8062272B2 (en) | 2004-05-21 | 2011-11-22 | Bluesky Medical Group Incorporated | Flexible reduced pressure treatment appliance |
US7909805B2 (en) | 2004-04-05 | 2011-03-22 | Bluesky Medical Group Incorporated | Flexible reduced pressure treatment appliance |
GB0409446D0 (en) | 2004-04-28 | 2004-06-02 | Smith & Nephew | Apparatus |
US10413644B2 (en) | 2004-04-27 | 2019-09-17 | Smith & Nephew Plc | Wound treatment apparatus and method |
GB0409291D0 (en) * | 2004-04-27 | 2004-06-02 | Smith & Nephew | Apparatus with stress |
GB0508528D0 (en) | 2005-04-27 | 2005-06-01 | Smith & Nephew | SAI with macrostress |
GB0409292D0 (en) * | 2004-04-27 | 2004-06-02 | Smith & Nephew | Apparatus with ultrasound |
GB0409444D0 (en) * | 2004-04-28 | 2004-06-02 | Smith & Nephew | Apparatus |
GB0409293D0 (en) * | 2004-04-27 | 2004-06-02 | Smith & Nephew | Apparatus with flow stress |
US8529548B2 (en) | 2004-04-27 | 2013-09-10 | Smith & Nephew Plc | Wound treatment apparatus and method |
US7753894B2 (en) | 2004-04-27 | 2010-07-13 | Smith & Nephew Plc | Wound cleansing apparatus with stress |
GB0508531D0 (en) | 2005-04-27 | 2005-06-01 | Smith & Nephew | Sai with ultrasound |
GB0424046D0 (en) * | 2004-10-29 | 2004-12-01 | Smith & Nephew | Apparatus |
EP1850910A1 (en) | 2005-02-07 | 2007-11-07 | Medtronic, Inc. | Ion imbalance detector |
US7699799B2 (en) * | 2005-08-26 | 2010-04-20 | Ceeben Systems, Inc. | Ultrasonic material removal system for cardiopulmonary bypass and other applications |
US7569742B2 (en) | 2005-09-07 | 2009-08-04 | Tyco Healthcare Group Lp | Self contained wound dressing with micropump |
US20070088269A1 (en) * | 2005-09-30 | 2007-04-19 | Sherwood Services Ag | Medical pump with lockout system |
US7534099B2 (en) * | 2005-09-30 | 2009-05-19 | Covidien Ag | Aliquot correction for feeding set degradation |
US20070093697A1 (en) * | 2005-10-21 | 2007-04-26 | Theranova, Llc | Method and apparatus for detection of right to left shunting in the cardiopulmonary vasculature |
US20180311071A1 (en) | 2005-10-21 | 2018-11-01 | Daniel R. BURNETT | Method and apparatus for peritoneal oxygenation |
US8715221B2 (en) * | 2006-03-08 | 2014-05-06 | Fresenius Medical Care Holdings, Inc. | Wearable kidney |
DE602007008395D1 (en) * | 2006-04-07 | 2010-09-23 | Nxstage Medical Inc | TUBE TERMINAL FOR MEDICAL APPLICATIONS |
US7779625B2 (en) | 2006-05-11 | 2010-08-24 | Kalypto Medical, Inc. | Device and method for wound therapy |
US20080249467A1 (en) * | 2007-04-05 | 2008-10-09 | Daniel Rogers Burnett | Device and Method for Safe Access to a Body Cavity |
CA2684807A1 (en) | 2007-04-05 | 2008-10-16 | Velomedix, Inc. | Automated therapy system and method |
GB0712763D0 (en) | 2007-07-02 | 2007-08-08 | Smith & Nephew | Apparatus |
US8512553B2 (en) | 2007-07-05 | 2013-08-20 | Baxter International Inc. | Extracorporeal dialysis ready peritoneal dialysis machine |
US7736328B2 (en) | 2007-07-05 | 2010-06-15 | Baxter International Inc. | Dialysis system having supply container autoconnection |
US7909795B2 (en) * | 2007-07-05 | 2011-03-22 | Baxter International Inc. | Dialysis system having disposable cassette and interface therefore |
US8715235B2 (en) * | 2007-07-05 | 2014-05-06 | Baxter International Inc. | Dialysis system having disposable cassette and heated cassette interface |
US8057423B2 (en) * | 2007-07-05 | 2011-11-15 | Baxter International Inc. | Dialysis system having disposable cassette |
EP2167000A1 (en) | 2007-07-09 | 2010-03-31 | Velomedix, Inc | Hypothermia devices and methods |
US8535522B2 (en) | 2009-02-12 | 2013-09-17 | Fresenius Medical Care Holdings, Inc. | System and method for detection of disconnection in an extracorporeal blood circuit |
US8597505B2 (en) | 2007-09-13 | 2013-12-03 | Fresenius Medical Care Holdings, Inc. | Portable dialysis machine |
US20090101577A1 (en) * | 2007-09-28 | 2009-04-23 | Fulkerson Barry N | Methods and Systems for Controlling Ultrafiltration Using Central Venous Pressure Measurements |
US9199022B2 (en) | 2008-09-12 | 2015-12-01 | Fresenius Medical Care Holdings, Inc. | Modular reservoir assembly for a hemodialysis and hemofiltration system |
US20090076434A1 (en) * | 2007-09-13 | 2009-03-19 | Mischelevich David J | Method and System for Achieving Volumetric Accuracy in Hemodialysis Systems |
US8475399B2 (en) | 2009-02-26 | 2013-07-02 | Fresenius Medical Care Holdings, Inc. | Methods and systems for measuring and verifying additives for use in a dialysis machine |
US8114288B2 (en) | 2007-11-29 | 2012-02-14 | Fresenlus Medical Care Holdings, Inc. | System and method for conducting hemodialysis and hemofiltration |
US8240636B2 (en) | 2009-01-12 | 2012-08-14 | Fresenius Medical Care Holdings, Inc. | Valve system |
US9308307B2 (en) | 2007-09-13 | 2016-04-12 | Fresenius Medical Care Holdings, Inc. | Manifold diaphragms |
US9358331B2 (en) | 2007-09-13 | 2016-06-07 | Fresenius Medical Care Holdings, Inc. | Portable dialysis machine with improved reservoir heating system |
US8105487B2 (en) | 2007-09-25 | 2012-01-31 | Fresenius Medical Care Holdings, Inc. | Manifolds for use in conducting dialysis |
US8114276B2 (en) | 2007-10-24 | 2012-02-14 | Baxter International Inc. | Personal hemodialysis system |
US9415150B2 (en) * | 2007-11-09 | 2016-08-16 | Baxter Healthcare S.A. | Balanced flow dialysis machine |
EP3000448B2 (en) | 2007-11-21 | 2022-03-09 | Smith & Nephew PLC | Wound dressing |
WO2009066105A1 (en) | 2007-11-21 | 2009-05-28 | Smith & Nephew Plc | Wound dressing |
GB0722820D0 (en) | 2007-11-21 | 2008-01-02 | Smith & Nephew | Vacuum assisted wound dressing |
US8808259B2 (en) | 2007-11-21 | 2014-08-19 | T.J. Smith & Nephew Limited | Suction device and dressing |
ES2382595T3 (en) * | 2008-01-08 | 2012-06-11 | Bluesky Medical Group Inc. | Wound treatment through variable and sustained negative pressure and method to control it |
EP2244760B8 (en) * | 2008-01-28 | 2022-07-20 | Implantica Patent Ltd. | An implantable drainage device |
AU2009223037A1 (en) | 2008-03-12 | 2009-09-17 | Smith & Nephew Plc | Negative pressure dressing and method of using same |
AU2009237693B2 (en) * | 2008-04-15 | 2013-11-14 | Gambro Lundia Ab | Blood treatment apparatus and method |
US9514283B2 (en) | 2008-07-09 | 2016-12-06 | Baxter International Inc. | Dialysis system having inventory management including online dextrose mixing |
US8062513B2 (en) | 2008-07-09 | 2011-11-22 | Baxter International Inc. | Dialysis system and machine having therapy prescription recall |
US20100184198A1 (en) * | 2009-01-16 | 2010-07-22 | Joseph Russell T | Systems and Methods of Urea Processing to Reduce Sorbent Load |
EP2323712B2 (en) * | 2008-09-18 | 2021-08-11 | KCI Licensing, Inc. | System for controlling inflammatory response |
WO2010042667A2 (en) | 2008-10-07 | 2010-04-15 | Xcorporeal, Inc. | Thermal flow meter |
AU2009302327C1 (en) * | 2008-10-07 | 2015-09-10 | Fresenius Medical Care Holdings, Inc. | Priming system and method for dialysis systems |
CN102639201B (en) | 2008-10-30 | 2015-07-08 | 弗雷塞尼斯医疗保健控股公司 | Modular, portable dialysis system |
CA2741572C (en) * | 2008-11-03 | 2017-10-31 | Fresenius Medical Care Holdings, Inc. | Portable peritoneal dialysis system |
US8663198B2 (en) | 2009-04-17 | 2014-03-04 | Kalypto Medical, Inc. | Negative pressure wound therapy device |
CA2772629C (en) * | 2009-09-08 | 2018-02-27 | Fresenius Medical Care Holdings, Inc. | Peritoneal dialysis system |
US9399091B2 (en) | 2009-09-30 | 2016-07-26 | Medtronic, Inc. | System and method to regulate ultrafiltration |
US8753515B2 (en) | 2009-12-05 | 2014-06-17 | Home Dialysis Plus, Ltd. | Dialysis system with ultrafiltration control |
US9061095B2 (en) | 2010-04-27 | 2015-06-23 | Smith & Nephew Plc | Wound dressing and method of use |
US8501009B2 (en) | 2010-06-07 | 2013-08-06 | State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of Oregon State University | Fluid purification system |
WO2012006625A2 (en) | 2010-07-09 | 2012-01-12 | Velomedix, Inc. | Method and apparatus for pressure measurement |
US9585810B2 (en) | 2010-10-14 | 2017-03-07 | Fresenius Medical Care Holdings, Inc. | Systems and methods for delivery of peritoneal dialysis (PD) solutions with integrated inter-chamber diffuser |
US20120199205A1 (en) | 2011-02-03 | 2012-08-09 | Fresenius Medical Care Deutschland Gmbh | System for preparing a medical fluid and method for preparing a medical fluid |
CN103492015A (en) | 2011-02-16 | 2014-01-01 | 塞奎阿纳医疗股份公司 | Apparatus and methods for treating intracorporeal fluid accumulation |
EP3536361B1 (en) | 2011-03-23 | 2020-10-07 | NxStage Medical Inc. | Peritoneal dialysis systems, devices, and methods |
US9456755B2 (en) | 2011-04-29 | 2016-10-04 | Medtronic, Inc. | Method and device to monitor patients with kidney disease |
US9192707B2 (en) | 2011-04-29 | 2015-11-24 | Medtronic, Inc. | Electrolyte and pH monitoring for fluid removal processes |
US9848778B2 (en) | 2011-04-29 | 2017-12-26 | Medtronic, Inc. | Method and device to monitor patients with kidney disease |
US9058634B2 (en) | 2011-05-24 | 2015-06-16 | Kalypto Medical, Inc. | Method for providing a negative pressure wound therapy pump device |
AU2011368701A1 (en) | 2011-05-24 | 2013-12-12 | Smith & Nephew, Inc. | Device with controller and pump modules for providing negative pressure for wound therapy |
US9067003B2 (en) | 2011-05-26 | 2015-06-30 | Kalypto Medical, Inc. | Method for providing negative pressure to a negative pressure wound therapy bandage |
ES2647775T3 (en) | 2011-08-02 | 2017-12-26 | Medtronic, Inc. | Hemodialysis system that has a flow path with a controlled distensible volume |
EP2744537B1 (en) | 2011-08-16 | 2018-01-24 | Medtronic, Inc. | Modular hemodialysis system |
US9328969B2 (en) | 2011-10-07 | 2016-05-03 | Outset Medical, Inc. | Heat exchange fluid purification for dialysis system |
US20130146541A1 (en) | 2011-12-13 | 2013-06-13 | Nxstage Medical, Inc. | Fluid purification methods, devices, and systems |
WO2013103906A1 (en) | 2012-01-04 | 2013-07-11 | Medtronic, Inc. | Multi-staged filtration system for blood fluid removal |
AU2013201567B2 (en) | 2012-11-28 | 2015-12-17 | Gambro Lundia Ab | Systems, apparatus, equipment with thermal disinfection and thermal disinfection methods |
US10905816B2 (en) | 2012-12-10 | 2021-02-02 | Medtronic, Inc. | Sodium management system for hemodialysis |
US20140158588A1 (en) * | 2012-12-10 | 2014-06-12 | Medtronic, Inc. | pH AND BUFFER MANAGEMENT SYSTEM FOR HEMODIALYSIS SYSTEMS |
US9201036B2 (en) | 2012-12-21 | 2015-12-01 | Fresenius Medical Care Holdings, Inc. | Method and system of monitoring electrolyte levels and composition using capacitance or induction |
US9157786B2 (en) | 2012-12-24 | 2015-10-13 | Fresenius Medical Care Holdings, Inc. | Load suspension and weighing system for a dialysis machine reservoir |
US11154648B2 (en) | 2013-01-09 | 2021-10-26 | Medtronic, Inc. | Fluid circuits for sorbent cartridge with sensors |
US9707328B2 (en) | 2013-01-09 | 2017-07-18 | Medtronic, Inc. | Sorbent cartridge to measure solute concentrations |
US9713666B2 (en) | 2013-01-09 | 2017-07-25 | Medtronic, Inc. | Recirculating dialysate fluid circuit for blood measurement |
US11565029B2 (en) | 2013-01-09 | 2023-01-31 | Medtronic, Inc. | Sorbent cartridge with electrodes |
US10543052B2 (en) | 2013-02-01 | 2020-01-28 | Medtronic, Inc. | Portable dialysis cabinet |
US9623164B2 (en) | 2013-02-01 | 2017-04-18 | Medtronic, Inc. | Systems and methods for multifunctional volumetric fluid control |
US9526822B2 (en) | 2013-02-01 | 2016-12-27 | Medtronic, Inc. | Sodium and buffer source cartridges for use in a modular controlled compliant flow path |
US10850016B2 (en) | 2013-02-01 | 2020-12-01 | Medtronic, Inc. | Modular fluid therapy system having jumpered flow paths and systems and methods for cleaning and disinfection |
US10010663B2 (en) | 2013-02-01 | 2018-07-03 | Medtronic, Inc. | Fluid circuit for delivery of renal replacement therapies |
US9144640B2 (en) | 2013-02-02 | 2015-09-29 | Medtronic, Inc. | Sorbent cartridge configurations for improved dialysate regeneration |
US9827361B2 (en) | 2013-02-02 | 2017-11-28 | Medtronic, Inc. | pH buffer measurement system for hemodialysis systems |
US20140263062A1 (en) | 2013-03-14 | 2014-09-18 | Fresenius Medical Care Holdings, Inc. | Universal portable machine for online hemodiafiltration using regenerated dialysate |
US9433720B2 (en) | 2013-03-14 | 2016-09-06 | Fresenius Medical Care Holdings, Inc. | Universal portable artificial kidney for hemodialysis and peritoneal dialysis |
US9440017B2 (en) | 2013-03-14 | 2016-09-13 | Baxter International Inc. | System and method for performing alternative and sequential blood and peritoneal dialysis modalities |
AU2014266943B2 (en) | 2013-05-10 | 2018-03-01 | Smith & Nephew Plc | Fluidic connector for irrigation and aspiration of wounds |
EP3010522B1 (en) | 2013-05-21 | 2021-01-20 | President and Fellows of Harvard College | Engineered heme-binding compositions and uses thereof |
CN105848581B (en) | 2013-11-04 | 2019-01-01 | 美敦力公司 | Method and apparatus for managing the body fluid volume in body |
US9354640B2 (en) | 2013-11-11 | 2016-05-31 | Fresenius Medical Care Holdings, Inc. | Smart actuator for valve |
US10537875B2 (en) | 2013-11-26 | 2020-01-21 | Medtronic, Inc. | Precision recharging of sorbent materials using patient and session data |
US9884145B2 (en) | 2013-11-26 | 2018-02-06 | Medtronic, Inc. | Parallel modules for in-line recharging of sorbents using alternate duty cycles |
US10617349B2 (en) | 2013-11-27 | 2020-04-14 | Medtronic, Inc. | Precision dialysis monitoring and synchronization system |
JP6657186B2 (en) | 2014-04-29 | 2020-03-04 | アウトセット・メディカル・インコーポレイテッドOutset Medical, Inc. | Dialysis system and method |
US10357757B2 (en) | 2014-06-24 | 2019-07-23 | Medtronic, Inc. | Stacked sorbent assembly |
EP3160535A4 (en) | 2014-06-24 | 2018-03-07 | Medtronic Inc. | Modular dialysate regeneration assembly |
US9895479B2 (en) | 2014-12-10 | 2018-02-20 | Medtronic, Inc. | Water management system for use in dialysis |
US10874787B2 (en) | 2014-12-10 | 2020-12-29 | Medtronic, Inc. | Degassing system for dialysis |
US10098993B2 (en) | 2014-12-10 | 2018-10-16 | Medtronic, Inc. | Sensing and storage system for fluid balance |
US9713665B2 (en) | 2014-12-10 | 2017-07-25 | Medtronic, Inc. | Degassing system for dialysis |
US10335534B2 (en) | 2015-11-06 | 2019-07-02 | Medtronic, Inc. | Dialysis prescription optimization for decreased arrhythmias |
JP6430425B2 (en) * | 2016-03-10 | 2018-11-28 | ミネベアミツミ株式会社 | Motor drive control device, motor drive control method, and tube pump |
US10874790B2 (en) | 2016-08-10 | 2020-12-29 | Medtronic, Inc. | Peritoneal dialysis intracycle osmotic agent adjustment |
US10994064B2 (en) | 2016-08-10 | 2021-05-04 | Medtronic, Inc. | Peritoneal dialysate flow path sensing |
CA3022893A1 (en) | 2016-05-06 | 2017-11-09 | Gambro Lundia Ab | Systems and methods for peritoneal dialysis having point of use dialysis fluid preparation using water accumulator and disposable set |
ES2908601T3 (en) | 2016-08-19 | 2022-05-03 | Outset Medical Inc | Peritoneal dialysis system and methods |
US10716922B2 (en) | 2016-08-26 | 2020-07-21 | Sequana Medical Nv | Implantable fluid management system having clog resistant catheters, and methods of using same |
US11013843B2 (en) | 2016-09-09 | 2021-05-25 | Medtronic, Inc. | Peritoneal dialysis fluid testing system |
US10981148B2 (en) | 2016-11-29 | 2021-04-20 | Medtronic, Inc. | Zirconium oxide module conditioning |
US10960381B2 (en) | 2017-06-15 | 2021-03-30 | Medtronic, Inc. | Zirconium phosphate disinfection recharging and conditioning |
US11179516B2 (en) | 2017-06-22 | 2021-11-23 | Baxter International Inc. | Systems and methods for incorporating patient pressure into medical fluid delivery |
EP3703777B1 (en) * | 2017-10-30 | 2024-07-03 | Baxter International, Inc. | Dextrose concentrate for the dialysate and for disinfecting |
US11278654B2 (en) | 2017-12-07 | 2022-03-22 | Medtronic, Inc. | Pneumatic manifold for a dialysis system |
US11033667B2 (en) | 2018-02-02 | 2021-06-15 | Medtronic, Inc. | Sorbent manifold for a dialysis system |
US11110215B2 (en) | 2018-02-23 | 2021-09-07 | Medtronic, Inc. | Degasser and vent manifolds for dialysis |
CA3092575A1 (en) | 2018-02-28 | 2019-09-06 | Nxstage Medical, Inc. | Fluid preparation and treatment devices, methods, and systems |
US11213616B2 (en) | 2018-08-24 | 2022-01-04 | Medtronic, Inc. | Recharge solution for zirconium phosphate |
US11806457B2 (en) | 2018-11-16 | 2023-11-07 | Mozarc Medical Us Llc | Peritoneal dialysis adequacy meaurements |
US11806456B2 (en) | 2018-12-10 | 2023-11-07 | Mozarc Medical Us Llc | Precision peritoneal dialysis therapy based on dialysis adequacy measurements |
US11850344B2 (en) | 2021-08-11 | 2023-12-26 | Mozarc Medical Us Llc | Gas bubble sensor |
US11965763B2 (en) | 2021-11-12 | 2024-04-23 | Mozarc Medical Us Llc | Determining fluid flow across rotary pump |
US11944733B2 (en) | 2021-11-18 | 2024-04-02 | Mozarc Medical Us Llc | Sodium and bicarbonate control |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5591344A (en) | 1995-02-13 | 1997-01-07 | Aksys, Ltd. | Hot water disinfection of dialysis machines, including the extracorporeal circuit thereof |
-
2000
- 2000-02-23 US US09/512,132 patent/US6254567B1/en not_active Expired - Fee Related
- 2000-02-25 WO PCT/US2000/005062 patent/WO2000050143A1/en active Application Filing
- 2000-02-25 AU AU32473/00A patent/AU3247300A/en not_active Abandoned
-
2001
- 2001-06-12 US US09/878,443 patent/US20010027289A1/en not_active Abandoned
Cited By (44)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110178455A1 (en) * | 2002-02-25 | 2011-07-21 | Burnett Daniel R | Implantable fluid management system for the removal of excess fluid |
US9913968B2 (en) | 2002-02-25 | 2018-03-13 | Sequana Medical Ag | Implantable fluid management system for the removal of excess fluid |
US9421347B2 (en) | 2002-02-25 | 2016-08-23 | Sequana Medical Ag | Implantable fluid management system for the removal of excess fluid |
US8882699B2 (en) | 2002-02-25 | 2014-11-11 | Sequana Medical Ag | Implantable fluid management system for the removal of excess fluid |
US8517973B2 (en) | 2002-02-25 | 2013-08-27 | Sequana Medical Ag | Implantable fluid management system for the removal of excess fluid |
US8992462B2 (en) | 2002-07-19 | 2015-03-31 | Baxter International Inc. | Systems and methods for performing peritoneal dialysis |
US9814820B2 (en) | 2002-07-19 | 2017-11-14 | Baxter International Inc. | Weight-controlled sorbent system for hemodialysis |
US7867189B2 (en) | 2002-07-19 | 2011-01-11 | Baxter International Inc. | System including machine interface for pumping cassette-based therapies |
US7922911B2 (en) | 2002-07-19 | 2011-04-12 | Baxter International Inc. | Systems and methods for peritoneal dialysis |
US20110144570A1 (en) * | 2002-07-19 | 2011-06-16 | Baxter International Inc. | Systems and methods for performing peritoneal dialysis |
EP2338543A1 (en) * | 2002-07-19 | 2011-06-29 | Baxter International Inc. | Systems for performing peritoneal dialysis |
US11235094B2 (en) | 2002-07-19 | 2022-02-01 | Baxter International Inc. | System for peritoneal dialysis |
US11020519B2 (en) | 2002-07-19 | 2021-06-01 | Baxter International Inc. | Systems and methods for performing peritoneal dialysis |
US8357113B2 (en) | 2002-07-19 | 2013-01-22 | Baxter International Inc. | Systems and methods for performing peritoneal dialysis |
US10363352B2 (en) | 2002-07-19 | 2019-07-30 | Baxter International Inc. | Disposable set and system for dialysis |
US20070213653A1 (en) * | 2002-07-19 | 2007-09-13 | Baxter International Inc. | System including machine interface for pumping cassette-based therapies |
US8597227B2 (en) | 2002-07-19 | 2013-12-03 | Baxter International Inc. | Weight/sensor-controlled sorbent system for hemodialysis |
US10179200B2 (en) | 2002-07-19 | 2019-01-15 | Baxter International Inc. | Disposable cassette and system for dialysis |
US8815095B2 (en) | 2002-07-19 | 2014-08-26 | Baxter International Inc. | Peritoneal dialysis systems and methods that regenerate dialysate |
WO2004008826A3 (en) * | 2002-07-19 | 2004-05-13 | Baxter Int | Systems and methods for performing peritoneal dialysis |
US7867214B2 (en) | 2002-07-19 | 2011-01-11 | Baxter International Inc. | Systems and methods for performing peritoneal dialysis |
US20040025693A1 (en) * | 2002-08-08 | 2004-02-12 | John Bedingfield | Gas venting device and a system and method for venting a gas from a liquid delivery system |
US6746514B2 (en) | 2002-08-08 | 2004-06-08 | Baxter International Inc. | Gas venting device and a system and method for venting a gas from a liquid delivery system |
US8206338B2 (en) | 2002-12-31 | 2012-06-26 | Baxter International Inc. | Pumping systems for cassette-based dialysis |
JP2007509681A (en) * | 2003-10-28 | 2007-04-19 | スミス アンド ネフュー ピーエルシー | Wound purification device using heat |
US8771221B2 (en) | 2003-11-03 | 2014-07-08 | Sequana Medical Ag | Implantable fluid management device for the removal of excess fluid |
US8398577B2 (en) * | 2003-11-03 | 2013-03-19 | Sequana Medical Ag | Implantable fluid management device for the removal of excess fluid |
US20090318844A1 (en) * | 2003-11-03 | 2009-12-24 | Novashunt Ag | Implantable fluid management device for the removal of excess fluid |
US11839712B2 (en) | 2004-08-18 | 2023-12-12 | Sequana Medical Nv | Implantable fluid management system for treating heart failure |
US10646634B2 (en) | 2008-07-09 | 2020-05-12 | Baxter International Inc. | Dialysis system and disposable set |
US11400193B2 (en) | 2008-08-28 | 2022-08-02 | Baxter International Inc. | In-line sensors for dialysis applications |
US11793916B2 (en) | 2012-02-15 | 2023-10-24 | Sequana Medical Nv | Systems and methods for fluid management |
US20190201608A1 (en) * | 2013-08-26 | 2019-07-04 | Roger Alan Mason | System and method for administering peritoneal dialysis |
WO2015031310A1 (en) * | 2013-08-26 | 2015-03-05 | Mason Roger Alan | Improved system and method for administering peritoneal dialysis |
US20150057602A1 (en) * | 2013-08-26 | 2015-02-26 | Roger Alan Mason | System and Method for Administering Peritoneal Dialysis |
US11495334B2 (en) | 2015-06-25 | 2022-11-08 | Gambro Lundia Ab | Medical device system and method having a distributed database |
US11854697B2 (en) | 2016-08-26 | 2023-12-26 | Sequana Medical Nv | Systems and methods for managing and analyzing data generated by an implantable device |
US11516183B2 (en) | 2016-12-21 | 2022-11-29 | Gambro Lundia Ab | Medical device system including information technology infrastructure having secure cluster domain supporting external domain |
US10918778B2 (en) | 2017-05-24 | 2021-02-16 | Sequana Medical Nv | Direct sodium removal method, solution and apparatus to reduce fluid overload in heart failure patients |
US11602583B2 (en) | 2017-05-24 | 2023-03-14 | Sequana Medical Nv | Direct sodium removal method, solution and apparatus to reduce fluid overload in heart failure patients |
US11559618B2 (en) | 2017-05-24 | 2023-01-24 | Sequana Medical Nv | Formulations and methods for direct sodium removal in patients having severe renal dysfunction |
US11464891B2 (en) | 2017-05-24 | 2022-10-11 | Sequana Medical Nv | Implantable pump for direct sodium removal therapy having on-board analyte sensor |
US11844890B2 (en) | 2017-05-24 | 2023-12-19 | Sequana Medical Nv | Formulations and methods for direct sodium removal in patients having heart failure and/or severe renal dysfunction |
WO2022146706A1 (en) * | 2020-12-29 | 2022-07-07 | Baxter International Inc. | Peritoneal dialysis cycler having heat cleaning |
Also Published As
Publication number | Publication date |
---|---|
WO2000050143A1 (en) | 2000-08-31 |
US6254567B1 (en) | 2001-07-03 |
AU3247300A (en) | 2000-09-14 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6254567B1 (en) | Flow-through peritoneal dialysis systems and methods with on-line dialysis solution regeneration | |
JP6966500B2 (en) | High convection home hemodialysis / hemofiltration and adsorbent system | |
JP6581609B2 (en) | System and method for performing peritoneal dialysis | |
US20040082903A1 (en) | Systems and methods for peritoneal dialysis | |
US20040069709A1 (en) | Fluid circuits, systems, and processes for extracorporeal blood processing | |
MXPA06006835A (en) | Medical fluid therapy flow control systems and methods. | |
CN109862926B (en) | Renal failure treatment system and method of cleaning using citric acid | |
USH1658H (en) | Technique for automatically preparing a dialysis machine at a predetermined date and time | |
US20230256150A1 (en) | Thermal disinfection system for a medical apparatus | |
US20230263948A1 (en) | Dialysis systems | |
EP3765115B1 (en) | Dialysis system having localized disinfection | |
CA3236091A1 (en) | Peritoneal dialysis system including a patient line filter having a tubular membrane | |
US20230248889A1 (en) | Peritoneal dialysis cycler having decreased ph disinfection | |
KR20240118159A (en) | Peritoneal dialysis system with capillary patient line filter | |
CN118369126A (en) | Peritoneal dialysis system with air assisted pumping sequence | |
KR20240118152A (en) | Peritoneal dialysis system comprising a patient line filter having a tubular membrane | |
CA3236211A1 (en) | Peritoneal dialysis system having an air return patient line filter | |
CA3236092A1 (en) | Peritoneal dialysis system having carbon dioxide injection to inhibit production of and/or remove calcium carbonate | |
CA3236088A1 (en) | Peritoneal dialysis system having a capillary patient line filter | |
WO2023060069A1 (en) | Peritoneal dialysis cycler using sorbent | |
CA3236212A1 (en) | Peritoneal dialysis system with dual lumen patient line and method for detection of occlusions | |
MXPA06005045A (en) | High convection home hemodialysis/hemofiltration and sorbent system |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |