Patent Application
20170281847
The invention relates to devices, systems, and methods for generating a peritoneal dialysate having purity and sterility characteristics suitable for Peritoneal Dialysis (PD) and regenerating used fluid for subsequent use. The peritoneal dialysate can be generated or regenerated from water or used fluid of variable quality using a dialysate generation flow path containing a sterilization module. The sterilization module can be any one or more of an ultrafilter, Ultraviolet (UV) light source, microbial filter, dialyzer, and combinations thereof. The peritoneal dialysate generation system and related methods can automatically generate peritoneal dialysate fluid and deliver peritoneal dialysis therapy to a patient with an integrated cycler and regenerate a used fluid for subsequent use as fresh peritoneal dialysate.
Peritoneal Dialysis (PD), including Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD), is a dialysis treatment that can be performed at home, either by the patient alone or with a care-giver. PD differs from Hemodialysis (HD) in that blood is not removed from the body and passed through a dialyzer, but rather a catheter is placed in the peritoneal cavity and dialysate introduced directly into the peritoneal cavity. Blood is cleaned inside the patient using the patient's own peritoneum as a type of dialysis membrane. However, because fluid is directly introduced into a human body, the fluid used for peritoneal dialysate is generally required to be free of biological and chemical contaminants. The peritoneal dialysate should also contain specified concentrations of solutes buffer, osmotic agent, and cations for biocompatibility and for performing membrane exchange.
Peritonitis is a serious and common problem in the PD population that results in abdominal pain, fever, and cloudy dialysate. Peritonitis remains a leading complication of PD with around 18% of infection-related mortality in PD patients resulting from peritonitis (Fried et al., “Peritonitis influences mortality in peritoneal dialysis patients,” J. Am. Soc. Nephrol. 1996; 7:2176-2182). Moreover, peritonitis is a contributing factor to death in 16% of deaths on PD, and remains a major cause for patients discontinuing PD and switching to HD. Peritonitis and other peritoneal dialysis complications can often be traced to non-sterile techniques and/or contaminated starting dialysate.
The US FDA regulates pre-packaged dialysate for use in PD as a Class II drug if the pre-packaged dialysate is used in either a semi-automatic PD system or an automatic PD system (e.g., cycler system). See 21 C.F.R. Sec. 876.5630. If the peritoneal dialysate is not pre-packaged, the US FDA requires the dialysate be prepared from a dialysate concentrate and “sterile purified water,” which is defined by the FDA in 21 C.F.R. Sec. 165.110(a)(2)(iv) and (vii). Some possible contaminants present in water used to prepare dialysis fluid can be (i) particles, (ii) chemicals, and (iii) microbial contaminants such as bacteria, fungi and yeasts, and microbial derivatives or fragments (e.g., endotoxins released during active growth and lysis of micro-organisms). In additional to meeting purity and sterility requirements, peritoneal dialysate must also contain specific and precise amounts of solutes, such as sodium chloride, sodium bicarbonate, and cation infusates.
Because traditional peritoneal dialysis systems require FDA-approved, pre-packaged dialysate, the dialysate can be expensive due to high manufacturing, shipping, and storage costs. Shortages can also occur. The problems are not mitigated by on-site dialysate preparation because the source water must still meet high fluid purity and sterility characteristics. Such standards may be difficult to meet, particularly for continuous, automatic peritoneal dialysis machines designed for home use. Further, traditional systems usually require storage of hundreds of liters of dialysate bags, including 300 L or more of peritoneal dialysate and over 300 kg of fluid per month. Storage and shipping of the peritoneal dialysate is expensive, labor intensive, and requires significant storage space.
Known systems and methods require significant space to store peritoneal dialysate prior to use. Continuous ambulatory peritoneal dialysis (CAPD) traditionally uses 1-4 exchanges of peritoneal dialysate a day, with an overnight dwell. Because each exchange requires approximately 2-4 L of peritoneal dialysate, use of prepackaged dialysate requires storing about 8-16 L of dialysate per day, or 56-112 L of dialysate per week. Automated peritoneal dialysis uses a cycler to cycle peritoneal dialysis into and out of the peritoneal cavity of the patient, generally at night. APD generally uses 3-5 exchanges daily, requiring up to 20 L of dialysate per day and up to 140 L of dialysate per week. Tidal Peritoneal Dialysis (TPD) is similar to APD with the exception that a between 250 mL to 1000 mL of the peritoneal dialysate is left in the peritoneal cavity of the patient between infusions. As such, the known treatments require significant amounts of clean water, which can deter using known systems, particularly in areas where clean water is scarce.
Hence, there is a need for systems and methods that can regenerate and reuse peritoneal dialysate after a first treatment, lowering the requirements for fresh water and storage space. There is also a need for a system that can regenerate used peritoneal dialysate and reuse the peritoneal dialysate with an integrated cycler, reducing the number of components necessary for peritoneal dialysis.
The first aspect of the invention relates to a system. In any embodiment, the system can include a water source; a peritoneal dialysate generation flow path; wherein the peritoneal dialysate generation flow path is fluidly connectable to the water source; one or more peritoneal dialysate regeneration modules fluidly connectable to the peritoneal dialysate generation flow path; a concentrate source fluidly connectable to the peritoneal dialysate generation flow path; the concentrate source containing one or more solutes; and a sterilization module fluidly connectable to the peritoneal dialysate generation flow path.
In any embodiment of the first aspect of the invention, the peritoneal dialysate generation flow path can include connectors for connection to a cycler.
In any embodiment of the first aspect of the invention, the system can include an integrated cycler; the integrated cycler having a pump, an infusion line, and a drain line; wherein the infusion line is fluidly connected to the peritoneal dialysate generation flow path downstream of the sterilization module; and wherein the drain line is fluidly connected to the peritoneal dialysate generation flow path upstream of the peritoneal dialysate regeneration module.
In any embodiment of the first aspect of the invention, the system can have one or more dialysate containers fluidly connectable to the peritoneal dialysate generation flow path downstream of the sterilization module.
In any embodiment of the first aspect of the invention, the concentrate source can include one or more of an osmotic agent and an ion concentrate.
In any embodiment of the first aspect of the invention, the concentrate source can include at least an osmotic agent source and an ion concentrate source.
In any embodiment of the first aspect of the invention, the concentrate source can include multiple osmotic agent sources.
In any embodiment of the first aspect of the invention, the osmotic agent sources can contain osmotic agents selected from the group of dextrose, icodextrin, amino acids, and glucose.
In any embodiment of the first aspect of the invention, the ion concentrate source can include one or more from the group of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate.
In any embodiment of the first or second aspect of the invention, the concentrate source can include multiple ion concentrate sources.
In any embodiment of the first aspect of the invention, the system can have a concentrate pump positioned between the concentrate source and the peritoneal dialysate generation flow path for controlled addition of fluid from the concentrate source to the peritoneal dialysate generation flow path.
In any embodiment of the first aspect of the invention, the system can have a control system for controlling one or more pumps and valves to control movement of fluid through the system.
In any embodiment of the first aspect of the invention, the control system can include a timer wherein the timer causes the control system to generate peritoneal dialysate at a predetermined time.
In any embodiment of the first aspect of the invention, the control system can include a user interface, wherein the user interface causes the control system to generate peritoneal dialysate at a selected time.
In any embodiment of the first aspect of the invention, the sterilization module can include one or more ultrafilters; a UV light source; a heater, a flash pasteurization module, a microbial filter; or combinations thereof.
In any embodiment of the first aspect of the invention, the sterilization module can include the UV light source positioned downstream of the ultrafilter.
In any embodiment of the first aspect of the invention, the peritoneal dialysate regeneration module can include one or more selected from the group of a sorbent cartridge, activated carbon, an ion exchange resin, a reverse osmosis module, a carbon filter, and a nanofilter.
In any embodiment of the first aspect of the invention, the integrated cycler can have a heater.
In any embodiment of the first aspect of the invention, the integrated cycler can have at least one sensor selected from the group of a flow meter, a pressure sensor, a conductivity sensor, and a temperature sensor.
In any embodiment of the first aspect of the invention, the system can have a second ultrafilter in the peritoneal dialysate generation flow path.
In any embodiment of the first aspect of the invention, the integrated cycler can include a filter in the infusion line.
The features disclosed as being part of the first aspect of the invention can be in the first aspect of the invention, either alone or in combination, or follow a preferred arrangement of one or more of the described elements.
The second aspect of the invention is drawn to a method. In any embodiment of the second aspect of the invention, the method can include the steps of pumping fluid through a peritoneal dialysate generation flow path having a peritoneal dialysate regeneration module; adding one or more concentrate solutions to the fluid in the peritoneal dialysate generation flow path; and pumping the fluid through a sterilization module.
In any embodiment of the second aspect of the invention, the fluid can be fluid returned to the peritoneal dialysate generation flow path from a peritoneal cavity of a patient.
In any embodiment of the second aspect of the invention, the method can include heating the fluid; pumping the fluid into a peritoneal cavity of a patient with an integrated cycler; and pumping the fluid from the peritoneal cavity of the patient into the peritoneal dialysate generation flow path.
In any embodiment of the second aspect of the invention, the method can include the step of pumping the fluid into one or more dialysate containers and pumping the fluid from the one or more dialysate containers into the peritoneal cavity of the patient.
In any embodiment of the second aspect of the invention, the step of adding one or more concentrate solutions to the fluid can include adding at least an osmotic agent and an ion concentrate to the fluid.
In any embodiment of the second aspect of the invention, the osmotic agent and ion concentrate can be added to the fluid from a single concentrate source.
In any embodiment of the second aspect of the invention, the osmotic agent and ion concentrate can be added from separate concentrate sources.
In any embodiment of the second aspect of the invention, the osmotic agent can be one or more selected from the group of glucose, dextrin, and icodextrin.
In any embodiment of the second aspect of the invention, the osmotic agent can include multiple osmotic agents.
In any embodiment of the second aspect of the invention, the multiple osmotic agents can be added from a single osmotic agent source.
In any embodiment of the second aspect of the invention, each of the multiple osmotic agents can be added from separate osmotic agent sources.
In any embodiment of the second aspect of the invention, the ion concentrate can be added from an ion concentrate source and can include one or more of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate.
In any embodiment of the second aspect of the invention, each of the ion concentrates can be added to the fluid from a single ion concentrate source.
In any embodiment of the second aspect of the invention, the ion concentrate source can include multiple ion concentrate sources; and each of the multiple ion concentrate sources can include different solutes.
In any embodiment of the second aspect of the invention, the step of adding one or more concentrate solutions to the fluid can include controlling an addition of concentrate from each of the ion concentrate sources to generate a peritoneal dialysate with a prescribed solute concentration.
In any embodiment of the second aspect of the invention, the method can be carried out by a peritoneal dialysate generation system having a control system.
In any embodiment of the second aspect of the invention, the peritoneal dialysate regeneration module can include one or more of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter and a nanofilter.
In any embodiment of the second aspect of the invention, the sterilization module can include one or more ultrafilters; a UV light source; a microbial filter; or combinations thereof.
In any embodiment of the second aspect of the invention, the sterilization module can include at least two ultrafilters.
The features disclosed as being part of the second aspect of the invention can be in the second aspect of the invention, either alone or in combination, or follow a preferred arrangement of one or more of the described elements.
Unless defined otherwise, all technical and scientific terms used have the same meaning as commonly understood by one of ordinary skill in the art.
The articles “a” and “an” are used to refer to one or to over one (i.e., to at least one) of the grammatical object of the article. For example, “an element” means one element or over one element.
“Activated carbon” refers to a form of carbon processed to have small pores, increasing the surface area available for adsorption.
The term “amino acid,” as used herein, refers to any nitrogen containing organic acid or peptide that can be used as an osmotic agent to generate peritoneal dialysate.
The term “calcium chloride source” refers to a source of calcium chloride in solid and/or solution form. The calcium chloride source can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports, any of which are fluidly connectable to each other or to a fluid flow path. The calcium chloride source can either be formed as a stand-alone enclosure or a compartment integrally formed with an apparatus for dialysis for containing a calcium chloride source.
A “carbon filter” is a bed of activated carbon.
The term “comprising” includes, but is not limited to, whatever follows the word “comprising.” Use of the term indicates the listed elements are required or mandatory but that other elements are optional and may be present.
A “concentrate pump” is a pump configured to move fluid between a concentrate source and a flow path.
A “concentrate solution” is a solution of one or more solutes in water. The concentrate solution can have a solute concentration greater than that to be used in dialysis.
A “concentrate source” is a source of one or more solutes. The concentrate source can have one or more solutes that has a solute concentration greater than the solute concentration to be used for dialysis.
A “conductivity sensor” is device for measuring the electrical conductance of a solution and/or the ion, such as a sodium ion, concentration of a solution.
A “connector” and “for connection” describe the concept of forming a fluid connection between two components wherein fluid, gas, or mixture of both gas and fluid can flow from one component, through a connector or a component for connection, to another component. The connector provides for a fluid connection in its broadest sense and can include any type of tubing, fluid or gas passageway, or conduit between any one or more components of the invention. The connection can optionally be disconnected and then reconnected.
The term “consisting of” includes and is limited to whatever follows the phrase “consisting of.” The phrase indicates the limited elements are required or mandatory and that no other elements may be present.
The term “consisting essentially of” includes whatever follows the term “consisting essentially of” and additional elements, structures, acts or features that do not affect the basic operation of the apparatus, structure or method described.
The terms “control,” “controlling,” or “controls” refers to the ability of one component to direct the actions of a second component.
A “control system” can be a combination of components that act together to maintain a system to a desired set of performance specifications. The control system can use processors, memory and computer components configured to interoperate to maintain the desired performance specifications. The control system can also include fluid or gas control components, and solute control components as known within the art to maintain the performance specifications.
The terms “controlled addition,” to “control addition,” or “controlling addition” refer to the ability to add one or more substances or fluids to a flow path or container in an accurately controllable amount.
The phrase “controlling the movement of fluid” refers to directing fluid through a flow path, container, receptacle, or reservoir of any type.
A “cycler” is a component for movement of fluid into and out of the peritoneal cavity of a patient.
The term “dextrose source” refers to a source of dextrose in solid and/or solution form. The dextrose source can interface with at least one other module found in systems for dialysis. The dextrose source can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports, any of which are fluidly connectable to each other or to a fluid flow path. The dextrose source can either be formed as a stand-alone enclosure or a compartment integrally formed with an apparatus for dialysis for containing a dextrose source.
The term “dialysate” describes a fluid into or out of which solutes from a fluid to be dialyzed diffuse through a membrane. Dialysate can differ depending on the type of dialysis to be carried out. For example, dialysate for peritoneal dialysis may include different solutes or different concentrations of solutes than dialysate for hemodialysis.
A “dialysate container” is any container capable of storing or containing dialysate for dialysis. The container any be of any suitable, size, geometry, or configuration.
The term “dialysis caddy” refers to a container detachably removable from a dialysis system, the caddy configured to hold one or more other containers. In any embodiment, the caddy can include one or more connectors for fluid connection from the containers to the dialysis system.
The term “downstream” refers to a position of a first component in a flow path relative to a second component wherein fluid will pass by the second component prior to the first component during normal operation. The first component can be said to be “downstream” of the second component, while the second component is “upstream” of the first component.
A “drain line” is a fluid line for carrying fluid to a drain such as a waste receptacle or drain. The drain line can be connected to a peritoneal cavity of a patient for draining fluid.
The term “filter” refers to a porous component through which fluid can pass, but that traps one or more materials within the fluid.
A “fitting feature” is any protrusion, indentation, groove, ridge, having any shape, size, or geometry that ensures that only a corresponding fitting feature complementary to the fitting feature can form a connection or fit to the corresponding fitting feature. The fitting feature can also include non-mechanical means for ensuring complementary connection such as magnets placed at particular locations, or visual or aural indicators such as color, lettering, or sound. The fitting feature can be affixed, integral, or labeled on a component or surface to ensure that a corresponding feature on a desired component or surface can mate or connect to the component or surface having the fitting feature.
A “flash pasteurization module” is a component or set of components capable of heating a fluid to a high temperature and recirculating the fluid for sterilization.
A “flow meter” is a device capable of measuring an amount or rate of fluid moving past or through a particular location.
The term “fluid” can be any substance that has no fixed shape that yields easily to external pressure such as a gas or a liquid. Specifically, the fluid can be water containing any solutes at any concentration. The fluid can also be dialysate of any type including fresh, partially used, or spent.
The terms “fluid connection,” “fluidly connectable,” or “fluidly connected” refer to the ability to pass fluid or gas from one point to another point. The two points can be within or between any one or more of compartments, modules, systems, and components, all of any type.
“Fluid returned to the peritoneal dialysate generation flow path from a peritoneal cavity of a patient” refers to fluid used in peritoneal cavity and then returned to the peritoneal dialysate generation flow path.
The terms “to generate peritoneal dialysate” or “peritoneal dialysate generation” refers to creating a peritoneal dialysate solution from constituent parts.
The term “glucose source” refers to a source of glucose in solid and/or solution form. The glucose source can interface with at least one other module found in systems for dialysis. The glucose source can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports, any of which are fluidly connectable to each other or to a fluid flow path. The glucose source can either be formed as a stand-alone enclosure or a compartment integrally formed with an apparatus for dialysis for containing a glucose source.
A “heater” is a component capable of raising the temperature of a substance, container, or fluid.
The terms “heating” or to “heat” refer to raising the temperature of a substance, fluid, or container.
An “integrated cycler” is a component for movement of fluid into and out of the peritoneal cavity of a patient, wherein the integrated cycler forms a part of an overall system. For example, the integrated cycler can be contained in a housing with other components used for peritoneal dialysis and be in fluid and electrical connection with desired components.
An “infusion line” is a fluid line for carrying peritoneal dialysate into a body cavity or part of a patient such as a peritoneal cavity.
An “ion concentrate” refers to one or more ionic compounds. The ion concentrate can have one or more ionic compounds in the ion concentrate. Further, the ion concentrate can have an ion concentration greater than an ion concentration to be used in dialysis.
An “ion concentrate source” refers to a source of one or more ionic compounds. The ion concentrate source can be in water or solid form. The ion concentrate source can further have one or more ionic compounds that is at a higher ion concentration greater than generally used in dialysis.
The term “ion exchange resin” refers to a material capable of removing ions from a fluid and releasing different ions into the fluid.
The term “level of sterility” refers to an estimated probability of viable organisms surviving a sterilization process.
The term “magnesium chloride source” refers to a source of magnesium chloride in solid and/or solution form. The magnesium chloride source can interface with at least one other module found in systems for dialysis. The magnesium chloride source can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports, any of which are fluidly connectable to each other or to a fluid flow path. The magnesium chloride source can either be formed as a stand-alone enclosure or a compartment integrally formed with an apparatus for dialysis for containing a magnesium chloride source.
The term “microbial filter” refers to a device inhibiting passage of microbes or fragments of microbes such as endotoxins in a fluid or solution while allowing the passage of the fluid or solution.
A “nanofilter” is a filter membrane having nanometer sized pores.
An “osmotic agent” is a substance dissolved in water capable of driving a net movement of water by osmosis across a semi-permeable membrane due to concentration differences of the osmotic agent on each side of the semi-permeable membrane.
An “osmotic agent source” refers to a source of osmotic agents in solid and/or solution form. The osmotic agent source can interface with at least one other module found in systems for dialysis. The osmotic agent source can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports, any of which are fluidly connectable to each other or to a fluid flow path. The osmotic agent source can either be formed as a stand-alone enclosure or a compartment integrally formed with an apparatus for dialysis for containing an osmotic agent source.
The term “peritoneal cavity” refers to the space between the parietal peritoneum and visceral peritoneum of a patient.
“Peritoneal dialysate” is a dialysis solution that can to be used in peritoneal dialysis having specified parameters for purity and sterility. Peritoneal dialysate is not the same as dialysate used in hemodialysis although peritoneal dialysate may be used in hemodialysis.
A “peritoneal dialysate generation flow path” is a path that can be used in generating dialysate suitable for peritoneal dialysis.
A “peritoneal dialysate generation system” refers to a collection of components used to generate peritoneal dialysate.
The term “peritoneal dialysate regeneration module” refers to a component or components capable of removing waste products from a fluid.
“Peritoneal dialysis” is a therapy wherein a dialysate is infused into the peritoneal cavity, which serves as a natural dialyzer. In general, waste components diffuse from a patient's bloodstream across a peritoneal membrane into the dialysis solution via a concentration gradient. In general, excess fluid in the form of plasma water flows from a patient's bloodstream across a peritoneal membrane into the dialysis solution via an osmotic gradient. Once the infused peritoneal dialysis solution has captured sufficient amounts of the waste components the fluid is removed. This cycle can be repeated for several cycles each day or as needed.
A “predetermined time” is a set time for an event to occur, such as a set time of day, or a set length of time from a previous event.
The term “prescribed solute concentration” refers to the concentration of one or more solutes in peritoneal dialysate intended for use by a patient.
The term “pressure sensor” refers to a device for measuring the pressure of a gas or liquid in a vessel, container, or fluid line.
The term “pump” refers to any device that causes the movement of fluids or gases by applying suction or pressure.
The terms “pumping fluid” or to “pump fluid” refer to moving a fluid through a flow path with a pump.
“Purified water” can be defined as water produced by distillation, deionization, reverse osmosis, or other suitable processes and that meets the definition of “purified water” in the United States Pharmacopeia, 23d Revision, Jan. 1, 1995, and the FDA at 21 CFR Section §165.110(a)(2)(iv). Other criteria for purified water can be determined by those of skill in the art, particularly as relating to purified water suitable for peritoneal dialysis.
The terms “regenerative peritoneal dialysis” or to “regenerate peritoneal dialysate” refer to removing waste products from used peritoneal dialysate to generate a fluid reusable in peritoneal dialysis.
A “reverse osmosis module” is a set of components that act to drive fluid through one or more semipermeable membranes, wherein pressure is used to move the fluid from a side of the semipermeable membrane with a higher concentration of one or more solutes to a side of the semipermeable membrane with a lower concentration of the one or more solutes.
A “selected time” is a set time chosen by a user or algorithm.
A “sensor” is a component capable of determining or sensing the states of one or more variables in a system.
The term “sodium chloride source” refers to a source of sodium chloride in solid and/or solution form. The sodium chloride source can interface with at least one other module found in systems for dialysis. The sodium chloride source can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports, any of which are fluidly connectable to each other or to a fluid flow path. The sodium chloride source can either be formed as a stand-alone enclosure or a compartment integrally formed with an apparatus for dialysis for containing a sodium chloride source.
The term “sodium lactate source” refers to a source of sodium lactate in solid and/or solution form. The sodium lactate source can interface with at least one other module found in systems for dialysis. The sodium lactate source can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports, any of which are fluidly connectable to each other or to a fluid flow path. The sodium lactate source can either be formed as a stand-alone enclosure or a compartment integrally formed with an apparatus for dialysis for containing a sodium lactate source.
A “solute” is a substance dissolved in a solvent, such as water.
The term “sorbent cartridge” refers to a cartridge containing one or more sorbent materials for removing specific solutes from solution. The term “sorbent cartridge” does not require the contents in the cartridge be sorbent based, and the contents of the sorbent cartridge can be any contents that can remove solutes from a dialysate. The sorbent cartridge may include any suitable amount of one or more sorbent materials. In certain instances, the term “sorbent cartridge” refers to a cartridge which includes one or more sorbent materials besides one or more other materials capable of removing solutes from dialysate. “Sorbent cartridge” can include configurations where at least some materials in the cartridge do not act by mechanisms of adsorption or absorption.
A “sterilization module” is a component or set of components to sterilize a fluid by removing or destroying chemical or biological contaminants.
A “temperature sensor” is a sensor capable of determining the temperature of a fluid.
A “timer” is a device capable of determining the time of day, or the time elapsed between multiple events.
An “ultrafilter” is a semi permeable membrane through which a fluid can pass and that can remove one or more solutes or particles from the fluid.
The term “upstream” refers to a position of a first component in a flow path relative to a second component wherein fluid will pass by the first component prior to the second component during normal operation. The first component can be said to be “upstream” of the second component, while the second component is “downstream” of the first component.
A “user interface” is a component that allows a user to communicate information or instructions to a processor or a memory device and to receive information or instructions from the processor or memory device.
A “UV light source” is a component that uses ultraviolet light to kill biological contaminants in a fluid.
A “valve” is a device capable of directing the flow of fluid or gas by opening, closing or obstructing one or more pathways to allow the fluid or gas to travel in a path. One or more valves configured to accomplish a desired flow can be configured into a “valve assembly.”
The term “water purification module” refers to a component or components capable of removing biological or chemical contaminants from water.
The term “water source” refers to a source from which potable or not potable water can be obtained.
The invention is drawn to systems and methods for regenerating and reusing peritoneal dialysate.
In any embodiment of the first or second aspects of the invention, the peritoneal dialysate regeneration module 104 can be a sorbent cartridge. The sorbent cartridge includes urease, a cation exchange material, an anion exchange material, and activated carbon. The urease can optionally be immobilized on alumina. The activated carbon operates to adsorb non-ionic molecules, organic molecules, and chlorine from the water, along with some endotoxins or bacterial contaminants. The activated carbon can be present in the sorbent cartridge in the form of a carbon filter or pad, or as a material layer in the sorbent cartridge. A carbon filter or pad is a bed of activated carbon. The carbon filter can be in a self contained packaging, or present as a layer of activated carbon within the sorbent cartridge. The urease catalyzes the conversion of urea in the dialysate into ammonium ions. The cation exchange material, such as zirconium phosphate, can remove cationic species from the fluid, such as potassium, calcium, magnesium, the ammonium ions generated by the reaction of urea, or other cations, replacing the cationic species with hydrogen or sodium. The sorbent cartridge can include any cation exchange material capable of removing cations from the fluid. The anion exchange material, such as zirconium oxide, can remove anionic species from the fluid, such as phosphate or fluoride molecules, replacing the anionic species with acetate or hydroxide ions. The sorbent cartridge can have any anion exchange material known in the art capable of removing anionic species from the fluid. In any embodiment, the sorbent cartridge can include aluminum oxide for removal of fluoride and heavy metals. In any embodiment, the sorbent cartridge can have a layer of aluminum oxide, followed by a layer of activate carbon, a layer of urease, and then an ion exchange resin. The sorbent cartridge can purify up to 3 L of water or used peritoneal dialysate per exchange, with flow rates of up to 300 ml/min. A larger sorbent cartridge can be used when generating peritoneal dialysate for multiple infusions, including a sorbent cartridge that can purify between 3 and 20 L, between 3 and 5 L, between 3 and 10 L, between 5 and 12 L, between 10 and 15 L, or between 10 and 20 L of water, or more.
In any embodiment, the sorbent cartridge can be a single use component or a rechargeable component. Recharging can refer to the process of treating a sorbent material to restore the functional capacity of the sorbent material so as to put the sorbent material back into a condition for use or reuse in a new dialysis session. In some instances, recharging also includes treating a sorbent material so as to clean the sorbent material so that the sorbent material can be stored and used in a subsequent dialysis session. In some instances, the total mass, weight and/or amount of “rechargeable” sorbent materials remain the same. In some instances, the total mass, weight and/or amount of “rechargeable” sorbent materials change. Without being limited to any one theory of invention, the recharging process may involve exchanging ions bound to the sorbent material with different ions, which in some instances may increase or decrease the total mass of the system. However, the total amount of the sorbent material will in some instances be unchanged by the recharging process. Upon a sorbent material undergoing “recharging,” the sorbent material can then be said to be “recharged.”
The sorbent cartridge can additionally include a microbial filter and/or a particulate filter. A microbial filter can further reduce the amount of endotoxins or bacterial contaminants present in the fluid. A particulate filter can remove particulate matter from the fluid. The sorbent materials described can be present in the sorbent cartridge in any order, or intermixed, so long as the zirconium phosphate is present downstream of the urease. The sorbent cartridge can be sized depending on the needs of the user, with a larger sized sorbent cartridge allowing for more exchanges before the sorbent cartridge must be replaced.
Alternatively, the peritoneal dialysate regeneration module 104 can be any component capable of removing contaminants from the fluid in the peritoneal dialysate generation flow path 101, including any one or more of a sorbent cartridge, reverse osmosis module, nanofilter, an ion exchange resin, a combination of cation and anion exchange materials, activated carbon, silica, or silica based columns.
After passing through the peritoneal dialysate regeneration module 104, the fluid is pumped to a concentrate source 105, where necessary components for carrying out peritoneal dialysis can be added from the concentrate source 105. The concentrates in the concentrate source 105 are utilized to create a peritoneal dialysis fluid that matches a dialysis prescription. Concentrate pump 106 can control the movement of concentrates from the concentrate source 105 to the peritoneal dialysate generation flow path 101 in a controlled addition. The concentrates added from the concentrate source 105 to the peritoneal dialysate generation flow path 101 can include any component prescribed for use in peritoneal dialysate. Table 1 provides non-limiting exemplary ranges of commonly used components of peritoneal dialysate.
To reduce the glucose degradation products (GDP) formed, some peritoneal dialysate systems use a low GDP formulation. Exemplary peritoneal dialysate concentrations for low GDP formulations are provided in Table 2. Generally, the low GDP peritoneal dialysate is provided in two separate bags, with one bag containing calcium chloride, magnesium chloride and glucose maintained at low pH, and the second bag containing sodium chloride and the buffer components, including sodium lactate and sodium bicarbonate. The two bags are mixed prior to use to generate a peritoneal dialysate with a neutral pH. Alternatively, a two chamber bag is used, the chambers separated by a divider which is broken to mix the fluids prior to use.
One of skill in the art will understand that other components can be used in place of the components listed in Tables 1-2. For example, dextrose as listed in Table 1 is commonly used as an osmotic agent. In any embodiment of the first or second aspects of the invention, other osmotic agents can be used in addition to, or in place of, the dextrose, including glucose, icodextrin or amino acid solutions, including dialysate with multiple osmotic agents. Although the sources of sodium, calcium, and magnesium listed in Table 1 are chloride salts, other sodium, magnesium, and calcium salts can be used, such as lactate or acetate salts. Peritoneal dialysate may also contain buffers for maintaining pH of the peritoneal dialysate. Exemplary, non-limiting examples of suitable buffers include bicarbonate buffer, acetate buffer or lactate buffer. Although not generally used in peritoneal dialysis, potassium chloride can be used for hypokalemic patients who don't receive sufficient potassium through diet. The concentrate source 105 can contain one or more osmotic agents, as well as one or more ion concentrates, such as concentrated sodium chloride, sodium lactate, magnesium chloride, calcium chloride, and/or sodium bicarbonate. In any embodiment, the system can have a single concentrate that has all components mixed for a daytime or overnight treatment for use in a home by a single patient. The concentrate source 105 can include separate sources for any one or more of the solutes that are to be used in the peritoneal dialysate. Alternatively, the concentrate source 105 can include a separate osmotic agent source, and an ion concentrate source each with a separate concentrate pump to add each component needed to create the peritoneal dialysate. Concentrate pump 106 pumps concentrated solutions from the concentrate source or sources 105 to the peritoneal dialysate generation flow path 101 in a controlled addition. Where more than one concentrate source is used, separate concentrate pumps can move each of the concentrates into the peritoneal dialysate generation flow path 101, or a single concentrate pump can be used, with valves configured allow individual control over the movement of each of the concentrate solutions to the peritoneal dialysate generation flow path 101.
One of skill in the art will understand that the peritoneal dialysate regeneration module 104 may not fully remove glucose, dextrose, icodextrin, or other osmotic agents. To control the amount of osmotic agent in the generated dialysate, the relative amounts of ionic solutes and osmotic agents required to be added may vary. To control the relative amounts of ions and osmotic agents in the dialysate where the peritoneal dialysate regeneration module 104 does not fully remove the osmotic agents, the concentrate source 105 can include a separate osmotic agent source and ion concentrate source. Refractive index sensor 120 determines the concentration of glucose or other osmotic agents in the dialysate downstream of the peritoneal dialysate regeneration module 104 and can control the addition of osmotic agents from the concentrate source 105.
After addition of solutes from the concentrate source 105, the fluid in the peritoneal dialysate generation flow path 101 can contain all the necessary solutes for peritoneal dialysis. Conductivity sensor 116 and refractive index sensor 117 are used to confirm the concentration of electrolytes and osmotic agents are within predetermined ranges.
The peritoneal dialysate should reach a level of sterility for peritoneal dialysis. The level of sterility can be any level that meets an applicable regulatory requirement, such as a sterility assurance level of 10−6 required by the FDA, meaning that the chance a viable organism is present after sterilization is 1 in 1,000,000. The system can pump the fluid to a sterilization module for sterilization of the peritoneal dialysate. The sterilization module can include one or more of a first ultrafilter 107, a second ultrafilter 121, and a UV light source (not shown in
After passing through the sterilization module, the peritoneal dialysate can be used in peritoneal dialysis. A dialysate storage container 108 can store the peritoneal dialysate until used. The peritoneal dialysate can pass through valve 109 and into the dialysate storage container 108. If ready for use, the peritoneal dialysate can be pumped from dialysate storage container 108, through valve 110, and back into the peritoneal dialysate generation flow path 101. Pump 111 provides a driving force for the movement of the peritoneal dialysate from the dialysate storage container 108 to the peritoneal dialysate generation flow path 101. Additional or alternative storage containers can be included at other locations in the peritoneal dialysate generation flow path 101. A storage container can be included upstream of the sterilization module, and downstream of the water purification module. Before the fluid is utilized in the cycler stage, the fluid can be pumped through the sterilization module, eliminating issues related to storage of sterile fluid. The storage containers can be either upstream or downstream of the concentrate source 105. Concentrates can be added to fluid before storing the fluid, or after storage of the fluid but prior to sterilization in the sterilization module. The peritoneal dialysate is then pumped through valve 112 and into infusion line 118. Infusion line 118 can include a connector 114 for connection to any non-integrated cycler (not shown in
After a dwell time in the peritoneal cavity of the patient, the peritoneal dialysate can be drained from the peritoneal cavity of the patient by the cycler and returned to the peritoneal dialysate generation flow path 101 for fluid regeneration for subsequent cycles. Connector 115 on drain line 119 can connect to a drain line of a non-integrated cycler to return the used peritoneal dialysate back to the peritoneal dialysate generation flow path 101 through valve 113. The fluid returned to the peritoneal dialysate generation flow path 101 from the peritoneal cavity of the patient can again be pumped through the peritoneal dialysate generation flow path 101 as described to regenerate the peritoneal dialysate for reuse in dialysis. A waste reservoir 122 can be fluidly connected to the peritoneal dialysate generation flow path 101 through valve 123 for removal of excess fluid drained from the peritoneal cavity of the patient.
The peritoneal dialysate regeneration system illustrated in
As described, any number of concentrate sources can be included in the peritoneal dialysate generation flow path 101. Table 3 provides exemplary non-limiting ranges of solutes that can be added from a single concentrate source 105 to the peritoneal dialysate generation flow path 101, including the starting concentration of the solutes in the concentrate source, as well as exemplary final volumes of the solutes in the dialysate and the exemplary flow rates of both the solutes and the water in the dialysate generation flow path that will achieve those concentrations. The solutes shown in Table 3 are traditional peritoneal dialysate solutes. Table 4 shows exemplary ranges of solutes that can be used as a low GDP formulation. Table 5 shows exemplary ranges of solutes that can be used with icodextrin as the osmotic agent. Icodextrin is sometimes used as an osmotic agent for a long dwell period. If dextrose or glucose is used in a long dwell period, reabsorption of the ultrafiltrate can occur, reducing the net volume of fluid removed. Icodextrin results in a long sustained ultrafiltration, and can provide improved ultrafiltration efficiency over a long dwell period. One of skill in the art will understand that the concentrations of any of the solutes shown in Tables 3-5 can be altered by altering the flow rates of the system pump 103 or concentrate pump 106. However, the ratio of the solutes included is fixed if using a single concentrate source 105. If the ratio of the solutes needs to be altered for any reason, a new concentrate solution may be needed.
Although using a single concentrate source in the system requires a fixed ratio of solutes in the generated peritoneal dialysate, a single concentrate source provides certain advantages. Storage requirements are decreased, as only a single concentrate solution needs to be stored for a given dialysate prescription. There is also a lower risk of patient error in adding solutes to the dialysate in the proper amounts. A single concentrate source also requires less supplies, less pumps, and less hardware. Further, because fewer containers are needed, the containers are easier to manage, clean, and disinfect. One of skill in the art will understand that a higher concentration of solutes in the concentrate source will allow minimization of the container size and maximization of the source water used in PD solution preparation, lowering costs. The limiting factor is mutual solubility of the components, which is generally limited by glucose or icodextrin solubility. The flow rate for the source water can be optimized to adjust the time required to prepare the solution. In the case of on-demand dialysate preparation, a high flow rate is desired to minimize the time needed to prepare the solution. The flow rate limit will be controlled by the metering accuracy of the concentrate pump at the rate required to match the water feed. With a single concentrate source, about 150 ml/exchange can be needed, corresponding to about 600 ml/day or 4.2 L/week. The concentrate source can be sized depending on the needs of the user, with a larger concentrate source requiring less frequent refilling.
To generate the peritoneal dialysate, solutes are added from concentrate sources 205, 206, and 207. As explained, any number of concentrate sources can be used. As illustrated in
The generated peritoneal dialysate can be sterilized by pumping the peritoneal dialysate through a sterilization module, shown as two ultrafilters 235 and 237 in
After the peritoneal dialysate is infused into the peritoneal cavity of a patient the peritoneal dialysate is held in the patient for a dwell period. After the dwell period, the peritoneal dialysate is drained from the patient. The fluid returned to the peritoneal dialysate generation flow path 201 from the peritoneal cavity of the patient is pumped through cycler connector 245 which can connect to a drain line of any non-integrated cycler (not shown). If a detachable dialysate container 246 is used, waste and storage reservoir 241 can be connected to collect used dialysate from the patient. After use, waste and storage reservoir 241 can be reconnected to the peritoneal dialysate generation flow path 201 and the used peritoneal dialysate pumped from the waste and storage reservoir 241 back into the peritoneal dialysate generation flow path 201. Flow meter 222 determines the amount of fluid removed from the patient, and pressure sensor 224 monitors the draw pressure when removing fluid from the patient. The used peritoneal dialysate can be removed from the patient through valve 240 by pump 239 and pumped into storage reservoir 241. The remaining used peritoneal dialysate can be pumped through the peritoneal dialysate generation flow path 201, and back through the sorbent cartridge 204 to regenerate the peritoneal dialysis. Connectors 257, 258, and 259 can be used to disinfect the peritoneal dialysate generation flow path 201.
To generate the peritoneal dialysate, solutes are added from concentrate sources 305, 306, and 307. As explained, any number of concentrate sources can be used. As illustrated in
The generated peritoneal dialysate can be sterilized by pumping the peritoneal dialysate through a sterilization module, shown as two ultrafilters 335 and 337 in
After a dwell period, the peritoneal dialysate is drained from the patient 349. The fluid is returned to the peritoneal dialysate generation flow path 301 from the peritoneal cavity of the patient 349. Drain pump 339 provides a driving force for draining the peritoneal dialysate from the patient 349. There is no set rate for draining peritoneal dialysate from the peritoneal cavity of the patient 349, and any flow rate can be used with the integrated cycler 345. A slow flow is defined as a drain flow rate of less than 50 mL/min for a standard fill, and less than 15 mL/min for a low fill. No flow is defined as a drain flow rate of less than 12 mL/min for a standard fill, and less than 3 mL/min for a low fill. If the detected flow rate of the drained dialysate is below the cutoffs, the system can generate an alarm. With the online generation of fluid described, a flow rate of 300 ml/min can support an exchange time of between 10 and 15 minutes for a full cycle of draining and filling the peritoneal cavity of a patient 349. The fill/drain cycle can be performed in 10 to 15 minutes with 2 to 3 L of fluid moving in total, half of which is moved into the peritoneal cavity and half of which is moved out of the peritoneal cavity. The peritoneal cavity can be drained with a slight negative pressure of about 50 to 100 mbar created by the drain pump 339. The drain rate can be up to 300 ml/minute or greater and can vary throughout the session. For example, a drain rate can be high such as at 300 ml/min, and then slow, such as to 100 ml/min, as the cavity approaches an empty point. Similarly, a fill rate can be as high as 300 ml/min, and also vary throughout a session. In the case of power failure during treatment, the valves and pumps can be closed to prevent any dialysate flow. If power is returned quickly, the therapy can resume. With a longer power failure, an alert can be generated instructing the patient 349 to manually drain the peritoneal dialysate. In any embodiment, a battery backup can be included in the case of power failure.
The used peritoneal dialysate is pumped through three-way valve 346 and back into peritoneal dialysate generation flow path 301. Flow meter 358 determines the amount of fluid removed from the patient 349, and pressure sensor 359 monitors the draw pressure when removing fluid from the patient 349. Peritoneal dialysate can be pumped through valve 340 into storage and waste reservoir 341 for storage of the removed fluid prior to starting delivery of regenerated fluid. The storage and waste reservoir 341 can be any size, including between 3-6 L. The remaining used peritoneal dialysate can be pumped through the peritoneal dialysate generation flow path 301, and back through the sorbent cartridge 304 to regenerate the peritoneal dialysis. Connectors 360, 361, and 362 are used to disinfect the peritoneal dialysate generation flow path 301.
For automated disinfection of the system, connector 347 can be connected to connector 360 to form a flow loop. Disinfectant can be circulated through the flow loop and heated. The disinfectant can be heated to any temperature capable of disinfecting the system, including temperatures of 90° C. or greater. The disinfectant can be introduced to the flow loop and recirculated at elevated temperatures to ensure complete disinfection. The disinfectant used can be any suitable disinfectant known in the art, including peracetic acid, citric acid, or bleach. The connectors and components of the system can be gamma and autoclave compatible to resist the high temperatures used during disinfection. The system can be primed by introducing a priming fluid to the peritoneal dialysate generation flow path 301 and integrated cycler 345.
By generating and immediately using the peritoneal dialysate, the dialysate storage time can be reduced, reducing the possibility of bacterial growth. A user interface can be included on the peritoneal dialysis generation system in communication with the control system, allowing a patient 349 to direct the generation of peritoneal dialysate at a selected time as needed at a selected time. Additionally, or alternatively, the peritoneal dialysate machine can include a timer, and the timer can cause the peritoneal dialysate machine to generate peritoneal dialysate at predetermined times according to the patient's 349 peritoneal dialysis schedule. Alternatively, the peritoneal dialysate generation machine can be equipped with wireless communication, such as Wi-Fi, Bluetooth, Ethernet, or any other wireless communication system known in the art to meet patient or clinic needs. The user can direct the peritoneal dialysis machine to generate peritoneal dialysate at a specified time from any location. By using a timer, user interface, or wireless communication to control the generation of peritoneal dialysate on demand, the peritoneal dialysate storage time can be reduced, lowering the chances of generating significant amounts of degradation products or allowing bacterial growth.
The peritoneal dialysate can be generated and used in real time, with direct infusion of the peritoneal dialysate into the patient through an integrated cycler. Alternatively, the peritoneal dialysate can be generated and stored prior to use with a non-integrated cycler. For real time generation and use of the peritoneal dialysate, the flow rate of fluid through the peritoneal dialysate generation flow path can be between 50 and 300 ml/min. If a dialysate storage container is used to store generated peritoneal dialysate, the flow rate of fluid through the peritoneal dialysate generation flow path can be any rate. The integrated or non-integrated cycler and the rest of the system can communicate for the purposes of generation and use of the peritoneal dialysate by any method known in the art, including Bluetooth, Wi-Fi, Ethernet, or direct hardware connections. Additional valves and regulators (not shown in
In any embodiment of the first or second aspects of the invention, solutes can be added to a peritoneal dialysate generation flow path 401 from two or more separate concentrate sources, as shown in
As illustrated in
Although shown as a refractive index meter 422 in
Although illustrated as a single concentrate source in
Although each concentrate source is illustrated in
The concentrate sources 402-406 can be single use concentrate sources or disposable concentrate sources. The disposable concentrate sources are used in a single peritoneal dialysate generation process and then disposed. Multiple use concentrate sources are used repeatedly, and refilled as necessary with the solute.
Table 6 provides exemplary, non-limiting, ranges of solutes that can be added to the peritoneal dialysate using a separate osmotic agent source, glucose in Table 6, and a separate ion concentrate source containing sodium chloride, sodium lactate, magnesium chloride, calcium chloride and sodium bicarbonate. Because the glucose is added separately from the ion concentrates, the ratio of glucose to the other solutes can be varied depending on the needs of the patient.
By using multiple concentrate sources, greater individualization and therapy customization can be achieved for each patient. With a single concentrate source, all solutes in the generated peritoneal dialysate must be present in a fixed ratio. By using more than one concentrate source, the ratio of solutes used in the peritoneal dialysate can be altered as the concentration of each of the osmotic agent and ion solutes can be individually controlled. For example, as illustrated by Table 6, with a single ion concentrate source and a single osmotic agent source, peritoneal dialysate with greater or less osmotic agent per concentration of ions can be generated, providing the ability to adjust the tonicity of the peritoneal dialysate solution independently of the electrolyte composition to meet the UF needs of any patient with a single set of solutions and allowing greater control over ultrafiltration. The ultrafiltration rate that results from using the peritoneal dialysate solutions can be altered by altering the concentration of the osmotic agent independently of the ionic solutes, or by changing the osmotic agent used. For example, typical ultrafiltration volumes using dextrose as the osmotic agent vary with the dextrose concentration of the peritoneal dialysate. With a 1.5% dextrose solution, the typical ultrafiltration volume is about 150 mL. With a 2.5% dextrose solution, the typical ultrafiltration volume is about 250 mL. With a 4.25% dextrose solution, the typical ultrafiltration volume can exceed 600 mL. For a single exchange using separate concentrate sources for the ion concentrates and the osmotic agent, about 50 mL of the ion concentrate and 150 mL of the osmotic agent may be needed, corresponding to about 200 ml/day or 1.4 L/week of the ion concentrate and 600 ml/day or 4.2 L/week of the osmotic agent.
Because the system is not limited to discrete glucose or other osmotic agent concentrations like known commercial solutions; the system can customize the peritoneal dialysate solutions to meet the ultrafiltration needs of patient as determined by a healthcare provider. As illustrated in Table 6, the glucose level in the peritoneal dialysate solution can be varied from 0.55 g/dL to 4.5 g/dL, while maintaining the electrolytes and buffer components constant, allowing the system to cover the range of glucose formulations currently offered commercially using a single Part A and Part B composition.
In any embodiment of the first or second aspects of the invention, two osmotic agent sources can be used, such as a dextrose source and an icodextrin source. With two osmotic agent sources, one could use dextrose during the daytime exchanges for CAPD and icodextrin during the night dwell to take advantage of the higher UF removal from icodextrin. Conversely, dextrose could be used during the night dwell and icodextrin for the extended daytime dwell in APD systems.
By using separate concentrate sources for each solute, complete individualization of the concentrations and ratios of solutes in the peritoneal dialysate can be achieved. Table 7 provides exemplary ranges of solutes that can be used in peritoneal dialysate as made by a system with each solute in a separate concentrate source. An advantage of using separate concentrate sources for each solute is that virtually any peritoneal dialysate solution composition can be prepared from a single set of component formulations. A system with separate concentrate sources for each solute is useful for patients whose prescriptions change periodically due to diet or other factors. Such patients would need to store multiple formulations if using only one or two concentrate sources, and the risk of errors would be increased.
In any embodiment, the one or more concentrate sources can be detachable from the rest of the system for sterilization. The concentrate sources can also be sterilized each time the concentrate sources are filled with new concentrate solutions. Further, the concentrate sources can be sterilized after a set number of uses, or after a set period of time. Moreover, the concentrate sources and the rest of the peritoneal dialysate generation system can be sterilized without any of the components by passing a disinfection solution, such as a citric acid, peracetic acid, or bleach solution, through all of the lines and containers of the system. Disinfectant can be circulated through the peritoneal dialysate generation system and heated. The disinfectant can be heated to any temperature capable of disinfecting the system, including temperatures of at least 90° C. or greater. The disinfectant can be introduced to the peritoneal dialysate generation system and recirculated at elevated temperatures, as needed, to ensure complete disinfection.
A fluid line 905 can connect a water source 904 to the peritoneal dialysate generation cabinet 901. The fluid line 905 can enter through a connector 928 in a top 906 of the water source 904. The fluid line 905 connects to the peritoneal dialysate generation flow path as described with reference to
As described, the peritoneal dialysate generation flow path can include various sensors for detection of conductivity, pH, refractive index, or other dialysate parameters. The sensors can be included either inside or outside of the body of the peritoneal dialysate generation cabinet 901. The fluid lines and valves connecting the components of the peritoneal dialysate generation flow path can likewise be positioned inside of the cabinet body. As described, a top of the peritoneal dialysate generation cabinet 901 can have a graphical user interface 902 including screen 903. Messages from the control system to the user, or from the user to the control system, can be generated and read through the graphical user interface 902. The user can direct the generation of peritoneal dialysate through the graphical user interface 902, and can receive messages from the system through screen 903. The system can generate alerts to the user, including any problems detected by any of the sensors, as well as the progress of peritoneal dialysate generation. A handle 924 can be included for opening the peritoneal dialysate generation cabinet 901 to allow access to components on the inside of the cabinet. Handles 921 and 923 can be included to hold the fluid lines and power cord when not in use.
Disinfection connector 922 illustrated in
As described, a top of the peritoneal dialysate generation cabinet 1001 can have a graphical user interface 1002 including screen 1003. Messages from the control system to the user, or from the user to the control system, can be generated and read through the graphical user interface 1002. The user can direct the generation of peritoneal dialysate through the graphical user interface 1002, and can receive messages from the system through screen 1003. The system can generate alerts to the user, including any problems detected by any of the sensors, as well as the progress of peritoneal dialysate generation. A handle 1020 can be included for opening the peritoneal dialysate generation cabinet 1001 to allow access to components on the inside of the cabinet. Handles 1021 and 1023 can be included to hold the fluid lines and power cord when not in use.
Disinfection connector 1022 can be included for disinfection of the waste line 1008. During disinfection, the waste line 1008 can be disconnected from the drain 1009 and connected to disinfection connector 1022. Disinfectant solution from a disinfectant source (not shown in
In any embodiment of the first or second aspects of the invention, the solute sources included in the dialysate generation module can be provided in a dialysis caddy. A dialysis caddy is a container adapted to contain one or more other containers, each having one or more solute sources. One non-limiting example of a dialysis caddy is shown in
If the dialysis caddy 1101 is configured to generate peritoneal dialysate, container connector 1107 on ion concentrate source 1103 and container connector 1108 on osmotic agent source 1104 can connect to caddy connectors 1115 on paddle assembly 1113 and caddy connector 1116 on paddle assembly 1114. Container connector 1109 on sodium chloride source 1105 can also connect to a caddy connector (not shown in
Alternatively, any method of loading the peritoneal dialysate concentrates can be included in the described systems. For example, the peritoneal dialysate concentrates can be added using a disposable cassette. The disposable cassette can be multi-use or single-use with disposal of the cassette after therapy.
The connectors can include connectors for connection to reservoirs, containers, or a tap or faucet. The connectors can be any type of connector that can form a seal with a container, tap, or faucet that serve as the fluid sources in the system. The connectors can be screw-type connectors that screw onto the containers, faucet or tap, snap-type connectors that snap onto the containers, faucet, or tap, or any other type of connector known in the art. O-rings or other sealing members can be included in the connectors to form a water-tight seal with the containers, faucet, or tap.
For connection to a tap or faucet, the connectors should be able to form a seal with standard at-home faucets. The connectors can include an adjustable bore, wherein the size of the opening of the connector for connection to the tap or faucet can be increased or decreased to adjust to different size faucets. Nuts, screws, or other tightenable components can be included on the sides of the connectors allowing a user to tighten the connector around the faucet or tap regardless of the circumference of the faucet or tap. An o-ring or other sealing member can be placed on the faucet or tap to increase the effectiveness of the seal formed with the connectors.
Alternatively, a fitting can be screwed onto, or otherwise affixed to the faucet with a male end of the fitting extending outwardly from the faucet. The male end of the fitting can be inserted into the water line, and secured with an adjustable bolt, wire, or other tightening mechanism to ensure a proper seal.
For connection to a drain as illustrated in
One skilled in the art will understand that various combinations and/or modifications and variations can be made in the described systems and methods depending upon the specific needs for operation. Moreover, features illustrated or described as being part of an aspect of the invention may be used in the aspect of the invention, either alone or in combination, or follow a preferred arrangement of one or more of the described elements.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/318,183 filed Apr. 4, 2016, the entire disclosure of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 62318183 | Apr 2016 | US |
