Patent Application
20170239410
The invention relates to and infusate frame for use in dialysis. The infusate frame includes one or more openings cut-out of a rigid support frame. The one or more openings are sized and shaped complementary to one or more infusate containers, ensuring that only a single infusate container can occupy a specific opening.
During priming of a dialysis system and during dialysis treatment, specific and concentrations of specific solutions, such as sodium chloride, sodium bicarbonate, and cation infusates, must be added to the dialysate flow path. Further, many cations, such as potassium, calcium and magnesium, can cross the dialyzer and be removed from a patient during dialysis. The cations must be added back into the dialysate to maintain the concentration of the cations at a desired level. Sodium bicarbonate can be used during dialysis as a buffer to control the pH of the dialysate and to treat acidosis by delivering bicarbonate across the dialysis membrane to the patient receiving a treatment. The amounts of sodium chloride, sodium bicarbonate and other cations added to dialysate should be closely monitored and controlled. Further, the amounts of each of the solutions necessary can vary considerably.
There is a need for ensuring proper solutes are added in proper amounts to the dialysate. To facilitate use of dialysis by personnel, systems and methods are needed that can ensure that any of the solutes or solutions are properly added to the dialysis system. Further, systems and methods are needed to ensure that all necessary components to be used during dialysis are connected to the dialysis system at the correct locations for a dialysate flow path. There is a further need for a system that can allow users of varying skill levels to easily configure the dialysis system for disinfection, and ensure that the dialysis system can be used outside of a clinical setting, such as in a patient's home, is needed.
The first aspect of the invention relates to an infusate frame. In any embodiment, the infusate frame can include a rigid planar surface having at least a first lip disposed at a periphery of the planar surface and extending outwardly from the planar surface; the lip complementary to a ledge disposed on a dialysis machine; one or more openings cut-out on the planar surface; the one or more openings extending from a first side to a second side of the planar surface; the one or more openings having a size and/or shape complementary to one or more infusate container; and a vertical axis of the opening can be aligned to a fluid connector disposed on the dialysis machine.
In any embodiment, the one or more openings can be tapered inwardly.
In any embodiment, at least one opening can be slotted to a periphery of the planar surface.
In any embodiment, the one or more openings can be selected from a circular shape, a square shape, a triangular shape, or an oval shape.
In any embodiment, the infusate frame can have one or more handles disposed on a periphery of the planar surface; the one or more handles extending upwardly from the planar surface.
In any embodiment, the infusate container can be selected from the group of a sodium bicarbonate container, a sodium chloride container, and a cation infusate container.
In any embodiment, the infusate frame can have at least one vertical support disposed on a periphery of the planar surface; the vertical support extending upwardly from the periphery of the planar surface with a lip extending horizontally from the vertical support.
In any embodiment, at least two openings can be cut-out on the planar surface, the at least two openings having different sizes or shapes.
In any embodiment, the infusate frame can have a second lip opposedly positioned on the planar surface to the first lip.
Any of the features disclosed as being part of the first aspect of the invention can be included in the first aspect of the invention, either alone or in combination.
The second aspect of the invention is drawn to a dialysis system. In any embodiment, the dialysis system can include the infusate frame of the first aspect of the invention having one or more infusate containers containing one or more solute; and a dialysis machine having (i) a dialysate flow path; (ii) a receiving compartment for the infusate frame; and (iii) one or more fluid connectors fluidly connectable to the one or more infusate containers and the dialysate flow path.
In any embodiment, the dialysis system can include one or more pumps and one or more valves fluidly connectable to the one or more fluid connectors; the one or more pumps and one or more valves controlling fluid flow from the one or more infusate containers into the one or more fluid connectors.
In any embodiment, the dialysis system can include a locking mechanism preventing the infusate frame from moving after insertion into the receiving compartment when the locking mechanism is in a locked state.
In any embodiment, the receiving compartment can be sized or shaped complementary to a size or shape of the infusate frame.
In any embodiment, the infusate frame can be formed integrally with the dialysis machine.
In any embodiment, the infusate frame can be removable from the dialysis machine.
In any embodiment, at least one pump can be a bidirectional pump.
In any embodiment, at least one fluid connector can be disposed on a moveable paddle.
In any embodiment, the one or more infusate containers can include a cation infusate container, a sodium chloride container, a sodium bicarbonate container, or combinations thereof.
In any embodiment, the sodium chloride container and sodium bicarbonate container can be fluidly connectable to a valve; wherein the valve is fluidly connected to the dialysate flow path upstream of a sorbent cartridge and downstream of the sorbent cartridge.
Any of the features disclosed as being part of the second aspect of the invention can be included in the second aspect of the invention, either alone or in combination.
Unless defined otherwise, all technical and scientific terms used herein generally have the same meaning as commonly understood by one of ordinary skill in the relevant 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 term “aligned” refers to a configuration of components wherein the components are positioned to a particular arrangement of components. For example, a fluid connection can be aligned to a movable connector to form a fluid connection between the components upon being positioned to a proper alignment.
The term “bi-directional connector” refers to a fluid connector through which fluid can move into or out of a container. The bi-directional connector can include separate channels for fluid movement in either direction, or a single channel used for both adding and removing fluid from the container.
The term “bi-directional pump” refers to a device configured to perform work on a fluid to cause the fluid to flow alternatively in either of two opposing directions.
The term “cation infusate container” refers to a source from which cations can be obtained. Examples of cations include, but are not limited to, calcium, magnesium and potassium. The source can be a solution containing cations or dry compositions that are hydrated by the system. The cation infusate container is not limited to cations and may optionally include other substances to be infused into a dialysate or replacement fluid; non-limiting examples can include glucose, dextrose, acetic acid and citric acid.
The term “circular” refers to a two-dimensional shape generally round, disk shaped, ring-shaped or annular, and having the form of a circle.
The term “complementary,” as used to describe fitting features, refers to one or more fitting features on a first component that are designed to pair or mate with one or more fitting features on a second component. For example, a first component may have a receiving compartment of particular dimensions, and the second component may be the same dimensions, such that the second component can mate within the receiving compartment.
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.
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 term “controlling fluid flow” or to “control fluid flow” refers to the ability to cause a fluid to move through a flow path in a specific direction, rate, or route.
The term “cut-out” refers to a removed portion of an otherwise continuous side or base of a component.
A “dialysate flow path” is a route in which a fluid can travel during dialysis.
“Dialysis” or “dialysis therapy” is a type of filtration, or a process of selective diffusion through a membrane. Dialysis removes solutes of a specific range of molecular weights via diffusion through a membrane from a fluid to be dialyzed into a dialysate. During dialysis, a fluid to be dialyzed is passed over a filter membrane, while dialysate is passed over the other side of that membrane. Dissolved solutes are transported across the filter membrane by diffusion between the fluids. The dialysate is used to remove solutes from the fluid to be dialyzed. The dialysate can also provide enrichment to the other fluid.
A “dialysis machine” is a system comprising a dialyzer, pumps, valves and fluid lines that is used to carry out a dialysis session.
The term “disposed” refers to a first component's placement on a second component.
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.
To “extend” refers to a component spanning a defined area or direction.
The term “extending horizontally” makes reference to a feature, such as a wall or a side of geometric shape, that extends from a point or line in a direction in a horizontal plane of the point or line.
The term “extending outwardly” makes reference to a feature that extends in a direction horizontally, vertically, or a combination thereof, from a second feature or component.
A “fluid” is a liquid substance optionally having a combination of gas and liquid phases in the fluid. Notably, a liquid can therefore also have a mixture of gas and liquid phases of matter.
The term “fluid connector,” “fluidly connectable,” or “fluidly connected” refers to the ability to pass fluid, gas, or mixtures thereof 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.
The term “fluid pump” or “pump” refers to any device that causes the movement of fluids or gases by applying suction or pressure.
The term “formed integrally” refers to two components that are permanently connected.
A “handle” can be a component on an infusate frame that is used to hold the infusate frame while moving the infusate frame.
An “infusate container” is a container adapted to contain one or more fluids for use in dialysis. The infusate container can at times hold dry chemicals that are later able to be reconstituted with a fluid to form a further useable fluid within the system.
An “infusate frame” is a component detachably removable from a dialysis system and having a substantially planar shape, configured to hold one or more containers.
A “ledge” is a flat structure extending outwardly from a side of a component.
The term “lip” refers to an edge portion of a component that contacts another component to result in a static position.
A “locked state” refers to a configuration of attached components wherein the components cannot easily be detached from one another.
A “locking mechanism” is any mechanism by which one component can be connected to a second component and resist inadvertent disconnection.
An “opening” is a portion of a component having a defined void space. As used in the invention, an opening in an infusate frame refers to a void space into which an infusate container can be inserted.
The term “opposedly positioned” refers to relative positions of two or more components wherein the two or more components are positioned on opposite sides of a reference.
The term “oval” refers to a two-dimensional shape having rounded ends and a slightly elongated shape.
The term “paddles” refers to components that can be rotatable, and in a preferred embodiment the paddles rotationally extend axially from a central axis. Multiple paddles can be used together as a “paddle assembly.”
The term “periphery” refers to an outer edge of a component.
The term “planar surface” refers to a surface of a component that is substantially flat and extending in two dimensions.
A “receiving compartment” is a portion of a container, caddy, device, or system adapted for receiving a component or container.
The term “removable” or “removed” relates to any component of the present invention that can be separated from a system, module, cartridge or any component of the invention.
The term “rigid” refers to a component having a substantially stiff structure that resist bending and is not generally flexible.
“Shape” refers to the three dimensional form of a component.
“Size” refers to the area, surface area, or volume of a container or component.
The term “slotted” refers to an opening extending inwardly from an outer edge of a component.
The terms “sodium bicarbonate container” refers to an object that can be a stand-alone enclosure or alternatively can be integrally formed with an apparatus for hemodialysis, hemodiafiltration, or hemofiltration. The object can store a source of sodium bicarbonate in solid and/or solution form, and can be configured to interface with at least one other functional module found in systems for hemodialysis, hemodiafiltration, or hemofiltration. The sodium bicarbonate reservoir or container can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports.
The terms “sodium chloride container” refers to an object that can be a stand-alone enclosure or alternatively can be integrally formed with an apparatus for hemodialysis, hemodiafiltration, or hemofiltration. The object can store a source of sodium, such as sodium chloride in solid and/or solution form, and can be configured to interface with at least one other functional module found in systems for hemodialysis, hemodiafiltration, or hemofiltration. The sodium chloride reservoir or container can contain at least one fluid pathway and include components such as conduits, valves, filters or fluid connection ports.
A “solute” is a substance dissolved in, or intended to be dissolved in, a solvent.
The term “square” refers to a two-dimensional shape having four edges and four angles. This description is not intended to limit the size and dimensions of the described components, and may therefore encompass components having corners with angles greater than or less than ninety degrees, and with edges of differing lengths with respect to each other.
A “support member” or “support” is any structure connected to a component designed to hold or rigidly affix the component in a particular location, configuration, or orientation.
The term “tapered inwardly” refers to a three-dimensional part of a component that extends gradually towards a point when moving from the outside of the component to the inside of the component.
The term “triangular” refers to a two-dimensional shape having three sides.
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.
The term “upwardly extending” makes reference to a feature, such as a wall or a side of geometric shape, that can be used to form a volume from a geometric based of any type. For example, a rectangular base having four sides can extend upwardly to form a cubic volume.
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 “vertical axis” refers to an imaginary line extending upwardly and downwardly through a point.
Lips 205 and 206, which are ledges disposed on a periphery of the planar surface 201 and outwardly extending from the planar surface 201, can be sized and shaped complementary to a ledge on a dialysis machine (not shown). The lips 205 and 206 can be opposedly positioned on opposite sides the planar surface 201. When the planar surface 201 is inserted into the dialysis machine, the lips 205 and 206 engage with the ledge to hold the infusate frame in place. The lips 205 and 206 can include vertical supports extending upwardly from the planar surface 201 with the lips 205 and 206 extending outwardly from the planar surface 201 horizontally from the vertical support, as illustrated in
The sodium chloride container 207, sodium bicarbonate container 208, and any additional infusate containers can be any type of infusate containers known in the art. As illustrated in
The infusate frame can be removable from the dialysis machine. Infusate containers can be placed in the infusate frame before or after inserting the infusate frame into the dialysis machine. Alternatively, the infusate frame can be non-removable, or formed integrally to the dialysis machine. The infusate containers can be placed into and removed from the infusate frame without removing the infusate frame from the dialysis machine.
After placing the infusate frame into a receiving compartment of the dialysis machine and placing the infusate containers into the infusate frame, the infusate containers can be connected to fluid connectors disposed on the dialysis machine. Each fluid connector can be aligned with a vertical axis of a single opening in the planar surface 201, ensuring that the correct fluid connector is connected to the correct infusate container during use. The fluid connectors can be any type of fluid connector known in the art. The fluid connectors can also be bi-directional connectors, allowing addition and removal of fluid from the infusate container through a single fluid connector.
In addition to having openings sized complementary to the infusate containers as illustrated in
The receiving compartment 301 can be sized and shaped complementary to the infusate frame with ledge 302 positioned complementary to the lip of the infusate frame. The receiving compartment 301, ledge 302, and infusate frame can be any shape, including rectangular shaped, circular shaped, oval shaped, triangle shaped, square shaped, or any other shape. Further, the infusate frame and receiving compartment 301 can be shaped to ensure that the infusate frame is only inserted in the proper orientation to align the infusate containers with the proper fluid connectors. For example, the receiving compartment 301 can have a smaller size or shape at one end and a larger size or shape on a second end. The infusate frame can be sized and shaped complementary, with different sizes or shaped on different ends of the infusate frame. The infusate frame will only be insertable into the receiving compartment 301 in a single orientation where the complementary sizes and shapes of the receiving compartment 301 and infusate frame match.
In addition to sizing and shaping the openings in the infusate frame to the infusate containers, an exterior surface of the fluid connectors can have a fitting feature to ensure proper mating to corresponding infusate container. For example, a first fluid connector can have a hexagonal-shape while a second fluid connector can have a circular-shape. The corresponding infusate containers can have surfaces matched to receive the hexagonal- or circular shaped fluid connectors. The fluid connectors and container connectors can have any complementary shape, including circular, rectangular, square, triangular, hexagonal, or any other shape known in the art. One skilled in the art will understand that additional solute containers can be included in the infusate frame, and that additional paddles and/or connectors can be included in the dialysis machine as necessary.
If
The receiving compartment 301 and infusate frame can also include an optional locking mechanism to keep the infusate frame from moving after insertion into the receiving compartment 301. Non-limiting examples of locking mechanisms include latches that engage when the infusate frame is inserted in the receiving compartment 301. The infusate frame cannot be moved once the latches are engaged until a user disengages the latches. The locking mechanism can be positionable in an open state, which will allow removal of the infusate frame or a locked state, which will prevent the infusate frame from moving. Any locking mechanism that can keep the infusate frame from moving within the receiving compartment 301 can be used.
Sodium bicarbonate container 402 can be connected to fluid lines 410 and 408. Fluid line 408 can also connect to valve 413 and can allow fluid from the dialysate flow path 406 to enter the sodium bicarbonate container 402. Fluid line 410 can also connect to valve 414. Cation infusate container 401 can be connected by fluid line 411 to the main dialysate flow path 406. Pump 404 can control fluid flow through line 411. Either or both of pumps 404 and 405 can be bi-directional pumps to move fluid from the containers within the infusate frame to the main dialysate flow path 406, or from the main dialysate flow path 406 to any of the containers within the infusate frame.
During treatment, various sensors can determine the concentration of sodium chloride, sodium bicarbonate, and cations added to the dialysate flow path 406 from the infusate frame containers. Conductivity sensor 418 can determine the conductivity of the dialysate prior to addition of sodium bicarbonate, sodium chloride, or other cations. Based on the conductivity detected by conductivity sensor 418, the amount of each fluid that needs to be added to the dialysate can be determined. Conductivity sensor 420, located downstream of fluid line 415, can determine the conductivity of the dialysate after addition of sodium bicarbonate, and ensures that the correct amount of sodium bicarbonate is added to the dialysate. Static mixer 419 can ensure complete mixing of the added sodium bicarbonate and the dialysate for accurate measurements by conductivity sensor 420. Conductivity sensor 422, located downstream of fluid line 411, can determine the conductivity of the dialysate after addition of the cation infusates, and ensure that the correct amount the cations is added to the dialysate. Conductivity sensor 422 can also provide a final check of the dialysate conductivity prior to the dialysate entering the dialyzer (not shown in
Sodium bicarbonate container 502 can be connected to fluid lines 510 and 508. Fluid line 508 can also connect to valve 513 and can allow water from the dialysate flow path 506 to enter the sodium bicarbonate container 502. Fluid line 510 can also connect to valve 514. Cation infusate container 501 can be connected by fluid line 511 to the main dialysate flow path 506. Pump 504 can control fluid flow through line 511.
As described, valve 516 allows fluid to be directed to the dialysate flow path 506 upstream of sorbent cartridge 518. To reuse a dialyzer (not shown 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.
This application is a continuation-in-part of U.S. patent application Ser. No. 15/219,238, filed on Jul. 25, 2016, which claims the benefit of U.S. Provisional Patent Application No. 62/196,891, filed on Jul. 24, 2015, the entire contents of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62196891 | Jul 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15219238 | Jul 2016 | US |
| Child | 15588772 | US |
