Patent Application
20190151527
The invention relates to a system of integrated manifolds for use in dialysis. The system of integrated manifolds can include two or more manifolds connected by fluid lines, the manifolds forming at least a portion of a dialysate flow path. In certain embodiments, valves, sensors, and/or pumps can be included. A controller can control the valves and pumps to pump fluid through the manifolds in a specified flow path.
Sorbent dialysis involves regeneration of a dialysate such that spent dialysate can be reused upon proper regeneration. A dialysate flow path is needed to direct the dialysate from an outlet of a dialyzer to an inlet of the dialyzer, as well as to remove toxins and solutes from the dialysate and add additional solutes necessary for reuse. Known dialysate flow paths use a system of fluid lines to direct dialysate in the flow path. The fluid lines are susceptible to twisting, blockage, or wearing out, interrupting dialysis treatment. Hence, there is a need for systems and methods that can use multiple integrated fluid manifolds to form portions of the dialysate flow path without excessive use of flexible fluid lines. The integrated manifolds reduce the chances of blockages in the dialysate flow path, while at the same time decrease the total space requirements for the system by replacing multiple fluid lines with a single manifold. There is a further need for systems and methods that can selectively direct fluid in a specified pathway throughout the dialysate flow path based on fluid parameters of the dialysate or mode of usage.
The first aspect of the invention relates to a system of integrated manifolds. In any embodiment, the system can comprise a dialysate flow path; the dialysate flow path fluidly connectable to a dialyzer inlet and a dialyzer outlet; the dialysate flow path comprising at least two manifolds; the at least two manifolds each comprising at least one internal conduit fluidly connecting a manifold inlet and a manifold outlet; a first fluid line fluidly connecting the dialyzer inlet to a first manifold; a second fluid line fluidly connecting the dialyzer outlet to a second manifold; and at least one fluid line fluidly connecting a manifold outlet of a least one manifold to a manifold inlet of at least one other manifold.
In any embodiment, the dialysate flow path can comprise at least three manifolds.
In any embodiment, at least one manifold can comprise at least one valve fluidly connecting the at least one internal conduit to either a first and second manifold outlet or a first and second manifold inlet.
In any embodiment, at least one valve can be in communication with a controller; the controller controlling the at least one valve to selectively direct fluid through the manifold from a specified inlet to a specified outlet.
In any embodiment, at least one manifold can comprise at least a first manifold outlet and a second manifold outlet fluidly connected to the at least one internal conduit; and at least one valve fluidly connecting the at least one internal conduit to the first manifold outlet and the second manifold outlet.
In any embodiment, at least one manifold can comprise at least a first manifold inlet and a second manifold inlet fluidly connected to the at least one internal conduit.
In any embodiment, at least one manifold can comprise at least a first internal conduit and a second internal conduit; wherein either both the first internal conduit and the second internal conduit are fluidly connected to a manifold inlet, or wherein both the first internal conduit and the second internal conduit are fluidly connected to a manifold outlet.
In any embodiment, the first internal conduit can be fluidly connected to the dialyzer inlet; and the second internal conduit can be fluidly connected to the dialyzer outlet.
In any embodiment, at least one manifold can comprise at least one sensor.
In any embodiment, the at least one sensor can be selected from the group consisting of: a pressure sensor, a conductivity sensor, a temperature sensor, a flow sensor, and combinations thereof.
In any embodiment, the dialysate flow path can comprise at least one dialysate pump external to a manifold.
In any embodiment, the dialysate flow path can comprise a sorbent cartridge external to a manifold.
In any embodiment, all valves within the dialysate flow path can be positioned within one or more manifolds.
In any embodiment, the system can comprise an ultrafiltrate reservoir fluidly connected to the dialysate flow path; the ultrafiltrate reservoir external to the at least two manifolds.
In any embodiment, the dialysate flow path can comprise a water source fluidly connected to the dialysate flow path; the water source external to the at least two manifolds.
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.
The second aspect of the invention relates to a method of using the system of integrated manifolds of the first aspect of the invention. In any embodiment, the method can comprise pumping a dialysate from the dialyzer outlet through a first manifold; pumping the dialysate from the first manifold through a second manifold; and pumping the dialysate from the second manifold to the dialyzer inlet.
In any embodiment, the method can comprise the step of controlling one or more valves within at least one manifold to selectively direct fluid from a specified manifold inlet to a specified manifold outlet.
In any embodiment, the step of controlling one or more valves can be performed by a controller in electronic communication with the one or more valves.
In any embodiment, the method can comprise the step of determining at least one fluid parameter of the dialysate with at least one sensor located within at least one manifold.
In any embodiment, the method can comprise the step of controlling one or more valves within at least one manifold to selectively direct fluid from a specified manifold inlet to a specified manifold outlet based on the at least one fluid parameter.
In any embodiment, the at least one fluid parameter can comprise a conductivity.
In any embodiment, the method can comprise the step of controlling at least one pump to direct a fluid from a concentrate source to the at least one internal conduit based on the at least one fluid parameter.
In any embodiment, the method can comprise the step of pumping a portion of the dialysate to an ultrafiltrate reservoir; wherein the ultrafiltrate reservoir is external to the manifolds.
In any embodiment, the method can comprise the step of pumping water from a water source to the dialysate flow path; wherein the water source is external to the manifolds.
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.
Unless defined otherwise, all technical and scientific terms used generally 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.
The terms “communicate” and “communication” include, but are not limited to, the connection of system electrical elements, either directly or remotely, for data transmission among and between said elements. The terms also include, but are not limited to, the connection of system fluid elements enabling fluid interface among and between said elements.
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 source” is a source of one or more solutes. The concentrate source can have one or more solutes with a solute concentration greater than the solute concentration to be used for dialysis. The concentrate in the concentrate source can also be lower than the solute concentration generally used in dialysis for generation of low concentration dialysate.
The term “conductivity” refers to the inverse of the electrical resistance of a fluid.
The term “conductivity sensor” refers to any component capable of measuring the electrical conductance or the electrical resistance of a fluid.
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.
A “controller” can refer to a device which monitors and affects the operational conditions of a given system. The operational conditions are typically referred to as output variables of the system wherein the output variables can be affected by adjusting certain input variables.
The terms “control,” “controlling,” or “controls” can refer to the ability of one component to direct the actions of a second component.
The term “determining” or “to determine” can refer to measuring any parameter or variable. The parameter or variable can relate to any state or value of a system, component, fluid, gas, or mixtures of one or more gases or fluids.
The term “dialysate flow path” refers to any portion of a fluid pathway that conveys a dialysate and is configured to form at least part of a fluid circuit for hemodialysis, hemofiltration, ultrafiltration, hemodiafiltration or ultrafiltration. Optionally, the dialysate flow path can contain priming fluid during a priming step or cleaning fluid during a cleaning step.
A “dialysate pump” is a component used to move fluid or gas throughout a dialysate flow path.
A “dialyzer inlet” is a portion of a dialyzer through which dialysate enters the dialyzer.
A “dialyzer outlet” is a portion of a dialyzer through which dialysate exits the dialyzer.
The term “external” refers to any area outside of a specified component.
The term “flow sensor” refers to a device for measuring a volume of a fluid or gas moved through a flow path per unit of time.
A “fluid line” can refer to a tubing or conduit through which a fluid or fluid containing gas can pass. The fluid line can also contain air during different modes of operation such as cleaning or purging of a line.
A “fluid parameter” is any sensed characteristic of a fluid, including temperature, pressure, concentration, color, conductivity, or any other characteristic.
The term “fluidly connectable,” “fluidly connect,” “for fluid connection,” and the like, can refer to the ability of providing for the passage of fluid, gas, or a combination thereof, from one point to another point. The two points can be within or between any one or more of compartments, modules, systems, components, and rechargers, all of any type. The connection can optionally be disconnected and then reconnected.
The term “integrated manifolds” refers to two or more manifolds, each containing at least one internal conduit that can be fluidly connected to form part of a fluid flow path.
An “internal conduit” can refer to a fluid pathway partially or entirely inside a manifold.
A “manifold” is a component having at least one inlet and one outlet fluidly connected to an internal conduit. Fluid can enter the manifold through the inlet, travel through internal conduit, and exit the manifold through the outlet. Optionally, the manifold can have multiple inlets and/or multiple outlets fluidly connected to one or more internal conduits.
A “manifold inlet” is a portion of a manifold through which fluid or gas can enter the manifold.
A “manifold outlet” is a portion of a manifold through which fluid or gas can exit the manifold.
The term “portion” refers to all or part of any type of object. In certain embodiments, the term can be used to describe part of a dialysate in a dialysate flow path.
The term “pressure sensor” can refer to a device or any suitable component for measuring the pressure of a gas or fluid in a vessel, container, or fluid line.
The term “pump” can refers to any device that causes the movement of fluids, gases, or combinations thereof, by applying force of any type including suction or pressure.
The terms “pumping” or to “pump” refer to moving a fluid or gas through a flow path with a pump.
“Selectively directing fluid” or to “selectively direct fluid” means to cause a fluid, gas, or combinations thereof to move in a specified flow path.
A “sensor” is a component capable of determining one or more states of one or more variables in a system.
The terms “sorbent cartridge” and “sorbent container” can refer to a cartridge containing one or more sorbent materials for removing specific solutes from solution, such as urea. 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 waste products from a dialysate. The sorbent cartridge may include any suitable amount of one or more sorbent materials. In certain instances, the term “sorbent cartridge” can refer to a cartridge which includes one or more sorbent materials in addition to one or more other materials capable of removing waste products from dialysate. “Sorbent cartridge” can include configurations where at least some materials in the cartridge do not act by mechanisms of adsorption or absorption. In any embodiment, a system may include a number of separate cartridges which can be physically separated or interconnected wherein such cartridges can be optionally detached and reattached as desired.
The term “specified” as used in relation to a component is meant to distinguish two similar components and is not intended to describe the structure or function of the component being described as “specified.”
The term “temperature sensor” refers to a device for measuring the temperature of a gas or liquid in a vessel, container, or fluid line.
An “ultrafiltrate reservoir” is a container into which fluids, gases, or combinations thereof, can be pumped from a dialysate flow path.
A “valve” refers to 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 source” refers to any source from which potable or non-potable water can be obtained.
Internal conduit 118 is fluidly connected to manifold outlet 119 and fluid line 134. An ultrafiltrate pump 120 can pump a portion of the fluid from valve 116, through internal conduit 118 and fluid line 134 to either ultrafiltrate reservoir 121, or alternatively, to a drain. In certain embodiments, the ultrafiltrate reservoir 121 can be positioned external to each of the manifolds, as illustrated in
If needed, water from a water source 127 can be pumped by pump 124 through fluid line 126 and into an internal conduit 123 of manifold 114 through manifold inlet 125. The water source 127 can be positioned external to each of the manifolds, as illustrated in
Fluid line 129 can fluidly connect to a second manifold 103 at manifold inlet 104. The dialysate can flow through manifold inlet 104 into internal conduit 111. Valve 106 selectively directs fluid into either internal conduit 107 or internal conduit 109. A conductivity sensor 105 can be included either inside or outside of the manifold 103 to determine the conductivity of the dialysate. In certain embodiments, conductivity sensor 105 can be in communication with the controller. If the conductivity as determined by conductivity sensor 105 indicates that the dialysate has solute concentrations outside of a predetermined range, the controller can control valve 106 to selectively direct fluid into internal conduit 109. Internal conduit 109 is fluidly connected to manifold outlet 110 and fluid line 113, which fluidly connects to fluid line 130 downstream of the dialyzer 102. As such, if the dialysate is not safe or effective to pump through the dialyzer 102, the controller can cause the fluid to bypass the dialyzer 102, where additional solutes can be added or the dialysate can be diluted with water from water source 127. Additional or alternative sensors (not shown), including temperature sensors, pressure sensors, pH sensors, and/or ammonia sensors can be included either inside or outside of the manifolds to determine one or more fluid parameters. If data from any of the sensors indicate an unsafe fluid parameter, the controller can control valve 106 to bypass dialyzer 102.
If the sensors indicate that the dialysate is within safe ranges for all fluid parameters, the controller can control valve 106 to direct fluid into internal conduit 107. Internal conduit 107 is fluidly connected to manifold outlet 108 and fluid line 112. The dialysate can be pumped through fluid line 112 and through the dialyzer inlet 132 to contact blood from the patient.
Water from a water source 227 can be pumped by pump 224 through fluid line 226 and into an internal conduit 223 of manifold 214 through manifold inlet 225 to dilute the dialysate and/or provide a fluid bolus to the patient. The water source 227 can be positioned external to each of the manifolds, as illustrated in
In certain embodiments, a sorbent cartridge 235 or other dialysate regeneration system can be employed to remove solutes and toxins from the dialysate, allowing the dialysate to be reused. The sorbent cartridge 235 can include one or more anion exchange resins, cation exchange resins, activated carbon, and urease. The urease catalyzes the conversion of urea in the dialysate to ammonium ions and carbonate ions. The ammonium ions can be subsequently captured by the cation exchange resin. Alternative methods of regenerating dialysate can be used in addition to, or in place of, sorbent cartridge 235, including systems that use reverse osmosis, electrodialysis, or other methods known in the art.
After passing through sorbent cartridge 235, the dialysate flows through fluid line 236 and into a second manifold 234 through manifold inlet 237 fluidly connected to internal conduit 238. In certain embodiments, a conductivity sensor 239 can be positioned either inside or outside of the manifold 234 to determine the conductivity of the dialysate exiting sorbent cartridge 235. Based on the determined conductivity bicarbonate can be added from bicarbonate concentrate source 248. Pump 250 can pump a bicarbonate concentrate from bicarbonate concentrate source 248, through fluid line 249 and into the second manifold 234 through manifold inlet 251. Manifold inlet 251 can be fluidly connected to internal conduit 252, which connects to internal conduit 238 to deliver the bicarbonate concentrate to the dialysate flow path 201.
Valve 240 can selectively direct fluid from internal conduit 238 into either internal conduit 241 or internal conduit 245. Internal conduit 241 is fluidly connected to manifold outlet 242 and fluid line 243, which can be used to convey fluid with bicarbonate added to a point in the dialysate flow path 201 upstream of the sorbent cartridge 235. By conveying a bicarbonate solution upstream of the sorbent cartridge 235 during priming of the system, the time required to prime the system can be reduced because the sorbent cartridge 235 need not be filled with water. During normal operation, the controller can control valve 240 to direct fluid into internal conduit 245. An optional conductivity sensor 244 can be included to determine the conductivity of the dialysate after addition of bicarbonate to ensure that the bicarbonate concentration is within a predetermined range.
An infusate concentrate source 253 can contain a concentrated solution of one or more infusates, including magnesium, potassium, and calcium, each of which may be removed by the sorbent cartridge 235. Infusate pump 255 can pump the infusate concentrate from the infusate concentrate source 253 through fluid line 254 and into the second manifold 234 through manifold inlet 257. The infusate concentrate is pumped through internal conduit 256 to internal conduit 245, where the infusate concentrate is mixed with the dialysate to generate a dialysate that can be safely pumped through dialyzer 202. The dialysate can exit the second manifold 234 through manifold outlet 246 and flow through fluid line 247 to a third manifold 203 through manifold inlet 204.
The dialysate can flow through manifold inlet 204 into internal conduit 211. Valve 206 can selectively direct fluid into either internal conduit 207 or internal conduit 209. A conductivity sensor 205 can be included either inside or outside of the third manifold 203 to determine the conductivity of the dialysate after addition of the infusates from infusate concentrate source 253. Though shown as part of the third manifold 203, one of skill in the art will understand that the conductivity sensor 205 can alternatively be positioned in manifold 234 or in fluid line 247 between the manifolds. If the conductivity as determined by conductivity sensor 205 indicates that the dialysate has solute concentrations outside of a predetermined range, the controller can control valve 206 to selectively direct fluid into internal conduit 209, manifold outlet 210 and into fluid line 213 to bypass the dialyzer 202. Additional or alternative sensors (not shown), including temperature sensors, flow sensors, pressure sensors, pH sensors, and/or ammonia sensors can be included either inside or outside of the manifolds, and can be used by the controller to determine whether valve 206 should be switched to bypass the dialyzer 202. For example, if the temperature of the dialysate is too low, if ammonia is present in the dialysate, if the pH of the dialysate is too high or too low, the controller can automatically control valve 206 to selectively direct fluid to manifold outlet 208, bypassing the dialyzer 202. Flow sensors can determine the net movement of fluid across the dialyzer 202 and can be used to control valve 216 and ultrafiltrate pump 220 to control the net ultrafiltration from the patient. If the sensors indicate that the dialysate is within safe ranges for all fluid parameters, the controller can control valve 206 to direct fluid into internal conduit 207, out of the third manifold 203 through manifold outlet 208 and into fluid line 212.
Any number of integrated manifolds can be included in the dialysate flow path, including 2, 3, 4, 5, 6, 7, 8 or more integrated manifolds, each with manifold inlet and manifold outlets to selectively convey fluid in a specified flow path. Each of the integrated manifolds can include any number of manifold inlets and manifold outlets. As illustrated in
The system of integrated manifolds can include one or more fluid lines fluidly connecting the integrated manifolds, as illustrated in
The connections between the manifold inlets, manifold outlets, and fluid lines can be any type of connections known in the art. In certain embodiments, a male portion of a connector can be provided on the manifold inlets and manifold outlets. The male portion of the connector can connect to a female portion at the ends of the fluid lines, or alternatively, can be inserted directly into the fluid lines. In certain embodiments, male portions of a connector can be included on the fluid lines and can be inserted into the manifold inlets and manifold outlets for connection to the internal conduits of the manifolds. Clamps or other means of securing the fluid lines to the manifold inlets and manifold outlets can be used in addition to, or as an alternative to, separate connectors.
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.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/589,959 filed Nov. 22, 2017, the entire disclosure of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 62589959 | Nov 2017 | US |
