Disposable cassette for a peritoneal dialysis system

Abstract

Systems, components, and methods are provided for a disposable peritoneal dialysis cassette. The disposable peritoneal dialysis cassette includes a diaphragm pump that is operated with a pneumatic system. The pneumatic system uses pneumatic surfaces having a plurality of openings in contact with the diaphragm pump to control pumping of fluid through the peritoneal dialysis cassette.

Description

DISPOSABLE CASSETTE FOR A PERITONEAL DIALYSIS SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 527,304, entitled “DISPOSABLE CASSETTE FOR A PERITONEAL DIALYSIS SYSTEM,” filed on July 17, 2023, the entire contents of which are hereby incorporated by reference.FIELD

[0002] Systems, components, and methods are provided for a disposable peritoneal dialysis cassette. The disposable peritoneal dialysis cassette includes a diaphragm pump that is operated with a pneumatic system. The pneumatic system uses pneumatic surfaces having a plurality of openings in contact with the diaphragm pump to control pumping of fluid through the peritoneal dialysis cassette.BACKGROUND

[0003] Peritoneal dialysis is a form of renal replacement therapy whereby a catheter is placed in the peritoneal cavity and peritoneal dialysis fluid is introduced directly into the peritoneal cavity. Blood is cleaned inside the patient using the patient's own peritoneum as a type of dialysis membrane. Hence, there is a need for a simplified and simple disposable kit that can be used by patients. The kit should be able to accurately administer the peritoneal dialysis fluid. The kit should be easy to mount on the peritoneal dialysis equipment, allowing inexperienced patients to set up the therapy. There is a further need for a peritoneal dialysis system that does not produce excess noise during treatment that may disturb the patient.SUMMARY OF THE INVENTION

[0004] The problem to be solved is operation of a diaphragm pump in a disposable peritoneal dialysis cassette. The solution is to use a pneumatic surface with a plurality of openings to allow pressure changes in a pneumatic chamber to expand or contract the pump chambers of the diaphragm pump.

[0005] The first aspect relates to a peritoneal dialysis cycler. The peritoneal dialysis cycler can include at least a first and a second pneumatic surface; each of the at least first and second pneumatic surfaces having a plurality of openings from the pneumatic surface to a first pneumaticchamber and second pneumatic chamber, respectively; each of the first pneumatic chamber and second pneumatic chamber connected to a pneumatic source; the pneumatic source operable to apply positive or negative pressure in the first pneumatic chamber and second pneumatic chamber.

[0006] In some embodiments, the peritoneal dialysis cycler can include a first and second gasket connectable to the first and second pneumatic surfaces, respectively, the first and second gasket connectable to first and second pump chambers of a diaphragm pump of a peritoneal dialysis cassette.

[0007] In some embodiments, each of the first and second gaskets can have openings.

[0008] In some embodiments, the openings of the first and second gaskets can be aligned with the openings on the first and second pneumatic surfaces.

[0009] In some embodiments, the openings of the first and second gaskets can be misaligned with the openings on the first and second pneumatic surfaces.

[0010] In some embodiments, each of the first and second gaskets can have a solid surface for contact with the first and second pneumatic surfaces.

[0011] In some embodiments, the first and second pneumatic surfaces can be connectable to first and second pump chambers of a diaphragm pump of a disposable cassette.

[0012] In some embodiments, application of positive or negative pressure in the first and second pneumatic chamber can cause pumping of the diaphragm pump.

[0013] The features disclosed as being part of the first aspect can be in the first aspect, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements. Similarly, any features disclosed as being part of the first aspect can be in a second aspect described below, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements.

[0014] The second aspect relates to a system. In some embodiments, the system can include (a) a peritoneal dialysis cycler; the peritoneal dialysis cycler having: at least a first and a second pneumatic surface; each of the at least first and second pneumatic surfaces having a plurality of openings from the pneumatic surface to a first pneumatic chamber and second pneumatic chamber, respectively; each of the first pneumatic chamber and second pneumatic chamber connected to apneumatic source; the pneumatic source operable to apply positive or negative pressure in the first pneumatic chamber and second pneumatic chamber; and (b) a peritoneal dialysis cassette; the peritoneal dialysis cassette having: at least a first flexible surface and a second surface; a diaphragm pump having at least a first pump chamber and second pump chamber; wherein the first and second pump chambers are connectable to the first and second pneumatic surfaces, respectively; and a plurality of fluid passages between the first flexible surface and second surface; the plurality of fluid passages fluidly connected to the first pump chamber and second pump chamber and to a plurality of inlet / outlet ports.

[0015] In some embodiments, the second surface can be a rigid surface.

[0016] In some embodiments, the second surface can be a flexible surface, and the peritoneal dialysis cassette can have a rigid body between the first flexible surface and the second flexible surface.

[0017] In some embodiments, the system can include a plurality of pinch clamps, the plurality of pinch clamps operable to occlude one or more of the plurality of fluid passages.

[0018] In some embodiments, the plurality of pinch clamps can be operable by a second pneumatic source.

[0019] In some embodiments, the system can include a control system; the control system programmed to control a first and a second solenoid valve to control pumping of fluid through the peritoneal dialysis cassette.

[0020] In some embodiments, the system can include a first gasket between the first pump chamber and the first pneumatic surface.

[0021] In some embodiments, the system can include a second gasket between the second pump chamber and the second pneumatic surface.

[0022] In some embodiments, each of the first and second gaskets can have openings.

[0023] In some embodiments, the openings of the first and second gaskets can be aligned with the openings on the first and second pneumatic surfaces.

[0024] In some embodiments, the openings of the first and second gaskets can be misaligned with the openings on the first and second pneumatic surfaces.

[0025] In some embodiments, each of the first and second gaskets can have a solid surface for contact with the first and second pneumatic surfaces.

[0026] In some embodiments, application of positive or negative pressure in the first and second pneumatic chamber can cause pumping of the diaphragm pump.

[0027] In some embodiments, the first and second pump chambers can be symmetrical circular chambers.

[0028] In some embodiments, the first flexible surface can have first and second concave portions aligned with the first and second pump chambers.

[0029] In some embodiments, the plurality of inlet / outlet ports can be all on a single edge of the peritoneal dialysis cassette.

[0030] In some embodiments, the system can include a gasket on the peritoneal dialysis cycler for mating with the peritoneal dialysis cassette.

[0031] The features disclosed as being part of the second aspect can be in the second aspect, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements. Similarly, any features disclosed as being part of the second aspect can be in the first aspect, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements.BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 shows a peritoneal dialysis cassette, according to some embodiments.

[0033] FIG. 2 shows an exploded view of a peritoneal dialysis cassette, according to some embodiments.

[0034] FIG. 3 is a diagram of a pneumatic system for operating the peritoneal dialysis cassette, according to some embodiments.

[0035] FIG. 4 is a top view of a peritoneal dialysis cycler, according to some embodiments.

[0036] FIG. 5 is a cross sectional view of a peritoneal dialysis cassette, according to some embodiments.

[0037] FIG. 6 is a diagram of a pneumatic system for operating a pinch clamp of a peritoneal dialysis system, according to some embodiments.

[0038] FIG.’s 7A-C show a peritoneal dialysis cycler for use with a peritoneal dialysis cassette, according to some embodiments.

[0039] FIG.’s 8A-B show a peritoneal dialysis cassette, according to some embodiments.DETAILED DESCRIPTION

[0040] Unless defined otherwise, all technical and scientific terms used have the same meaning as commonly understood by one of ordinary skill in the art.

[0041] The articles “a” and “an” are used to refer to one 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.

[0042] The term “aligned” refers to two sets of components located in a linear relationship.

[0043] The terms “application of pressure” or to “apply pressure” refer to the use of a gas to apply force on one or more components.

[0044] 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.

[0045] The terms “connected,” “connection,” to “connect,” or “connectable” refers to the ability of forming physical contact between two components or parts. The connection need not be permanent.

[0046] 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.

[0047] 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.

[0048] The terms “control,” “controlling,” or “controls” can refer to the ability of one component to direct the actions of a second component.

[0049] 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 performance specifications.

[0050] A “diaphragm pump” is a pump that operates to move fluid or gas by expanding and contracting a volume of one or more pump chambers.

[0051] A “flexible surface” refers to a surface of a component that can be deformed or bent without tearing or breaking.

[0052] A “fluid passage” is a conduit or pathway through which fluid or gas can move.

[0053] The term “fluidly connectable,” “fluid connection,” “fluidly connectable,” “fluidically engage”, or “fluidically coupled” refers to the ability of providing for the passage of fluid, gas, or combination thereof, from one point to another point. The ability of providing such passage can be any connection, fastening, or forming between two points to permit the flow of fluid, gas, or combinations thereof. The two points can be within or between any one or more of compartments of any type, modules, systems, components, and rechargers.

[0054] The term “fluidly connected” refers to a particular state such that the passage of fluid, gas, or combination thereof, is provided from one point to another point. The connection state can also include an unconnected state, such that the two points are disconnected from each other to discontinue flow. It will be further understood that the two “fluidly connectable” points, as defined above, can form a “fluidly connected” state. The two points can be within or between any one or more of compartments, modules, systems, components, and rechargers, all of any type.

[0055] A “gasket” refers to a component placed at the junction of two different interacting components.

[0056] An “inlet / outlet port” is an opening or conduit through which fluids can enter or exit a component.

[0057] The term “misaligned” refers to two sets of components that are not located in a linear relationship.

[0058] “Negative pressure” refers to an air pressure less than the surrounding area.

[0059] The term “occlude” means to block a fluid passage, preventing fluid movement through the passage.

[0060] An “opening” is a conduit for a fluid or gas through a component.

[0061] The term “peritoneal dialysis cassette” refers to a grouping of components that are arranged together for attachment to, or use with a peritoneal dialysis device, apparatus, or system. One or more components in a cassette can be any combination of single use, disposable, consumable, replaceable, or durable items or materials.

[0062] The term “peritoneal dialysis cycler” or “cycler” refers to components for movement of fluid into and out of the peritoneal cavity of a patient, with or without additional components for generating peritoneal dialysate or performing additional functions.

[0063] A “pinch clamp” is component that contacts a membrane surface to apply force to the membrane surface closing or opening a fluid conduit.

[0064] A “pneumatic chamber” is a space into which gas can be pumped or withdrawn to operate pneumatic components.

[0065] A “pneumatic source” is a component or set of components that can pump or release gas to operate pneumatic components.

[0066] A “pneumatic surface” refers to a surface of a component or components that operate via pressure caused by a gas.

[0067] “Positive pressure” refers to an air pressure greater than the surrounding area.

[0068] The term “programmable” or “programmed” refers to an electronic system that can receive instructions to perform specified actions.

[0069] A “pump chamber” is an area into which fluid or a gas can flow having an expandable and contractable volume to draw in or expel the fluid or gas.

[0070] The terms “pumping” or to “pump” refer to the movement of a fluid or gas by application of pressure.

[0071] A “rigid surface” refers to a surface of a component that will generally not bend or deform during use.

[0072] A “solenoid valve” is a component that can allow, block, or direct the movement of a fluid or gas through one or more conduits operated by electromagnetic force.

[0073] A “solid surface” is a planar or curved surface without any openings.

[0074] The term “symmetrical circular chambers” refers to two or more chambers having a generally round shape of the same size.Disposable Peritoneal Dialysis Cassette

[0075] FIG. 1 shows a peritoneal dialysis cassette 101 having a disposable diaphragm pump, according to some embodiments. FIG. 1 shows the bottom side of the peritoneal dialysis cassette 101. Although not shown in FIG. 1, the peritoneal dialysis cassette 101 has a first rigid surface on a bottom side and a second flexible surface on the top side.

[0076] As illustrated in FIG. 1, the peritoneal dialysis cassette 101 can include one or more inlet / outlet ports. Depending on the particular action being performed, fluid can be drawn into the peritoneal dialysis cassette 101 through any of the inlet / outlet ports and drawn out of the peritoneal dialysis cassette 101 through any of the inlet / outlet ports. That is, in some embodiments, each inlet / outlet port can be used as both an inlet and an outlet to perform specified actions.

[0077] In FIG. 1, the peritoneal dialysis cassette 101 includes one or more inlet / outlet ports. As a non-limiting example, the peritoneal dialysis cassette 101 can include a first inlet / outlet port 104 used for automatic sampling of the peritoneal dialysate, a second inlet / outlet port 105 used for a drain line, a third inlet / outlet port 106 for the connection with a patient line, a fourth inlet / outletport 107 used to connect to a heating bag line, a fifth inlet / outlet port 108 for a first pre-filled bag connection, a sixth inlet / outlet port 109 for a second pre-filled bag connection, a seventh inlet / outlet port 110 for a third pre-filled bag connection, and an eighth inlet / outlet port 111 for the connection with a fourth pre-filled bag. However, the peritoneal dialysis cassette can include any number of inlet / outlet ports, including more or fewer inlet / outlet ports than illustrated in FIG. 1 depending on the needs of the user and system. In some embodiments, the functions of each inlet / outlet port can be changed, adjusted, or swapped with the function of another inlet / outlet port. For example, in some embodiments, the order described above can be adjusted or changed.

[0078] As described, the peritoneal dialysis cassette can include a plurality of fluid passages. As illustrated in FIG. 1, inlet / outlet port 104 and inlet / outlet port 105 can be connected to fluid passage 114. Inlet outlet port 106 can be connected to fluid passage 116. Inlet / outlet port 107 can be connected to fluid passage 124. Inlet / outlet port 108, inlet / outlet port 109, inlet / outlet port 110, and inlet / outlet port 111 can each connect to fluid passage 123. Pump chamber 102 can be fluidly connected to fluid passage 117 and fluid passage 121, as well as fluid passage 118 through 112. Pump chamber 103 can be fluidly connected to fluid passage 119 and fluid passage 122, as well as fluid passage 120 through 113. An additional fluid passage 115 can be included to facilitate the movement of fluid through the peritoneal dialysis cassette 101. One of skill in the art will understand that the number of fluid passages, as well as the arrangement of fluid passages can be varied. The design illustrated in FIG. 1 is for illustrative purposes only. In some embodiments, each fluid passage can be selectively occluded. By selectively occluding connections between the fluid passages, fluid can be moved through the peritoneal dialysis cassette 101 from any inlet / outlet port to any other inlet / outlet port.

[0079] The diaphragm pump can include a first pump chamber 102 and a second pumping chamber 103. When pressure is applied to the flexible membrane over first pump chamber 102, the flexible membrane is pushed inwardly towards the rigid side of the peritoneal dialysis cassette 101. As the flexible membrane is pushed inwardly, the fluid within the first pump chamber 102 can be acted upon and can be forced out of the first pump chamber 102. In some embodiments, the force from the membrane can be an increase in pressure. When the pressure on the flexible membrane over first pump chamber 102 can be released, the flexible membrane can expand outwardly, drawing fluid into the first pump chamber 102. The same action forces fluid into andout of second pump chamber 103. As illustrated in FIG. 1, the first pump chamber 102 and the second pumping chamber 103 are fluidly connected to a plurality of fluid passages. Operating the diaphragm pump while selectively occluding passage of fluid through one more of the fluid passages allows fluid to be directed from a selected fluid inlet port to a selected fluid outlet port. As illustrated in FIG. 1, the first pump chamber 102 and second pumping chamber 103 can be symmetrical circular chambers. In some embodiments, other shapes, such as oval or even noncircular shapes can be used.

[0080] In some embodiments, the dialysis cassette 101 can include one or more pressure sensing regions, including a first pressure sensing region 112 and second pressure sensing region 113. The membrane side of the peritoneal dialysis cassette 101, which can be above the first pressure sensing region 112 and second pressure sensing region 113, can be in contact with pressure sensors that can measure the force exerted on the membrane by fluid moving through the peritoneal dialysis cassette 101.

[0081] FIG. 2 is an exploded view of a peritoneal dialysis cassette 201, as illustrated in FIG. 1. The peritoneal dialysis cassette 201 can include a first surface that is a flexible membrane 202. The flexible membrane 202 can allow portions of the surface to move inward or outward from the rest of the peritoneal dialysis cassette 201 by application of pressure. As described, the diaphragm pump can operate by application of pressure on the flexible membrane 202 over the pump chambers, which can drive fluid into and out of the pump chambers. Movement of fluid through the peritoneal dialysis cassette 201 can be controlled by valves (not shown) that apply pressure to the flexible membrane 202 at connections between fluid passages, allowing or preventing the movement of fluid between the fluid passages.

[0082] The peritoneal dialysis cassette can include a rigid body 203. The rigid body can include the pump chambers for the diaphragm pump, as well as the fluid passages through the peritoneal dialysis cassette 201. The bottom of the peritoneal dialysis cassette 201 can, in some embodiments, be a rigid cover 204. Additionally, a flexible film can be used as a cover for the bottom of the peritoneal dialysis cassette. The rigid cover can cover the fluid passages through the rigid body 203 and can include indentations to allow for fluid movement through the fluid passages.

[0083] FIG. 3 illustrates a peritoneal dialysis cycler at the interface between the peritoneal dialysis cycler and the diaphragm pump of a peritoneal dialysis cassette, according to an embodiment. The peritoneal dialysis cycler can include a pneumatic surface 302 for applying pressure to the pump chambers of the peritoneal dialysis cassette. As described, applying pressure to the pump chambers can, in some embodiments, cause a flexible membrane (not shown in FIG. 3) of the peritoneal dialysis cassette to move in or out, expanding or contracting the pump chamber and expelling or drawing in fluid. The peritoneal dialysis cassette can include two or more pump chambers, and as such, the peritoneal dialysis cycler can include two or more pneumatic surfaces, with one surface for each pump chamber of the peritoneal dialysis cassette.

[0084] As illustrated in FIG. 3, the pneumatic surface 302 of the peritoneal dialysis cycler can include a plurality of openings, such as opening 307. As illustrated in FIG. 3, the pneumatic surface 302 can include any number of openings. The openings can allow pressure in a pneumatic chamber 301 to interact with the pump chambers of the diaphragm pump. When air is pushed into the pneumatic chamber 301, a positive pressure can be exerted on the pump chamber. When air can be withdrawn from pneumatic chamber 301, a negative pressure can be exerted on the pump chamber. The pneumatic chamber 301 can be a space between the pneumatic surface 302 and the main body of the peritoneal dialysis cycler 309. As such, application of positive or negative pressure in the pneumatic chamber 301 can cause pumping of the diaphragm pump.

[0085] The pneumatic chamber 301 can be connected to a pneumatic manifold for controlling the movement of air into or out of the pneumatic chamber 301. A control system (not shown) can operate the pneumatic source as well as one or more valves to control the movement of air into and out of the pneumatic chamber 301.

[0086] Positive pressure can be exerted by flowing air into the pneumatic chamber 301 through positive pressure line 305 from a pneumatic source (not shown in FIG. 3). Withdrawing air, or allowing air to escape, through negative pressure line 304 can reduce pressure on the pump chamber, allowing expansion of the pump chamber. A solenoid valve 303 can be included to control the movement of air into and out of the pneumatic chamber 301.

[0087] In some embodiments, the pneumatic surface 302 can directly contact the pump chamber of the peritoneal dialysis cassette. In some embodiments, as illustrated in FIG. 3, a gasket306 can be included between the pneumatic surface 302 and the pump chamber of the peritoneal dialysis cassette 101. Including a gasket 306 can reduce the incidence of tearing of the flexible membrane of the peritoneal dialysis cassette 101 during use. When a gasket 306 is used, the gasket can include a plurality of openings, such as opening 308, to permit the pressure in the pneumatic chamber 301 to interact with the pump chambers of the diaphragm pump. In some embodiments, as illustrated in FIG. 3, the openings 308 of the gasket 306 can be aligned with the openings 307 of the pneumatic surface 302. In some embodiments, the openings 308 of the gasket 306 can be misaligned with the openings 307 of the pneumatic surface 302. In some embodiments, the gasket 306 can be a solid surface, without openings 308.

[0088] A top view of a pneumatic surface 401 is illustrated in FIG. 4. As described, the pneumatic surface 401 can include a plurality of openings 402 to allow pressure to be applied to the pump chambers of a diaphragm pump in a disposable peritoneal dialysis cassette (not shown in FIG. 4). The openings 402 can provide a passageway from a pneumatic chamber (not shown in FIG. 4) to the top of the pneumatic surface 401. The pneumatic surface 401 can, in some embodiments, contact the flexible membrane of the peritoneal dialysis cassette directly. In some embodiments, a gasket (not shown in FIG. 4) can be included between the pneumatic surface 401 and the flexible membrane. When a gasket is used, the gasket can include openings as well to allow pressure to be exerted or withdrawn from the flexible membrane.

[0089] FIG. 5 is a cross-sectional view of a peritoneal dialysis cassette showing the movement of fluid between fluid passages. As described, the peritoneal dialysis cassette can have a flexible membrane surface 503 and a rigid surface 504, as well as a rigid cassette body 505. Fluid passages through the peritoneal dialysis cassette can be defined on one side by the flexible membrane 503 and the rigid cassette body 505, and on the other side by the rigid surface 504 and the rigid cassette body 505.

[0090] Fluid can move through a first fluid passage 501 into a second fluid passage 502, going from a first side of the rigid cassette body 505 to the second side of the rigid cassette body 505. In FIG. 5, the connection between fluid passage 501 and fluid passage 502 can be open, allowing fluid movement. However, if pressure is applied to a flexible membrane 503, the flexible membrane 503 can be pushed inwardly, blocking the opening into fluid passage 502. Thus, byselectively applying pressure at specified locations on the flexible membrane 503, in some embodiments, the fluid passages can be selectively occluded, causing fluid to move in only a specified direction.

[0091] FIG. 6 illustrates use of pinch clamps to selectively occlude fluid passages through a peritoneal dialysis cassette 604, according to some embodiments. In some embodiments, the pinch clamp 601 can be connected to a pneumatic source (not shown in FIG. 6) using pneumatic connector 602. The pneumatic source used to operate the pinch clamps can be a separate pneumatic source as that used to operate the diaphragm pump. A control system (not shown in FIG. 6) can be included to operate the pneumatic source and one or more valves to control the pinch clamp 601. A solenoid valve 606 can be connected to the pneumatic connector 602 through line 605. As described, the peritoneal dialysis cassette 604 can include several fluid passages, connections between each of which can be controlled with a separate pinch clamp. As such, the system can include several pinch clamps similar to pinch clamp 601 each connected to solenoid valves. A pneumatic manifold (not shown in FIG. 6) can be used to connect each solenoid valve to the pneumatic source. In some embodiments, other methods of occluding the fluid passages can be included. For example, actuatable fluid passages that collapse in on themselves can be utilized.

[0092] Application of positive pressure through positive pressure line 607 can cause the pinch clamp 601 to extend outwardly, pushing against the flexible membrane 603 of the peritoneal dialysis cassette 604. Release of pressure through negative pressure line 608 can allow the pinch clamp 601 to be retracted, reducing pressure on the flexible membrane 603, and allowing fluid to pass through the fluid passage.

[0093] In some embodiments, the pinch clamp 601, when extended, can occlude a portion of a fluid passage, or a connection between fluid passages, preventing fluid movement through a portion of the peritoneal dialysis cassette 604. By selectively operating the various pinch clamps used, fluid can be directed through the peritoneal dialysis cassette 604 from a first specified inlet / outlet port to a second specified inlet / outlet port.

[0094] FIG.’s 7A-C show a peritoneal dialysis cycler 702. FIG. 7A is a perspective view of a peritoneal dialysis cycler 702 without a cassette loaded. FIG. 7B is a front view of the peritonealdialysis cassette chamber inside the peritoneal dialysis cycler 702. FIG. 7C is a cross-sectional view of the peritoneal dialysis cycler 702.

[0095] As illustrated in FIG. 7A, the peritoneal dialysis cycler 702 can include a receiving compartment 703, for installation of chemicals, bags, and other components. A closeable top 704 can be included to control access to the receiving compartment 703. The top 704 can then be closed prior to treatment. A door 706 can be included for installation of a peritoneal dialysis cassette 101. To install a peritoneal dialysis cassette 101, the door 706 can be opened and the peritoneal dialysis cassette 101 placed inside a receiving compartment (not shown in FIG. 7A). Although illustrated as loading through the door 706 of the peritoneal dialysis cycler 702, one of skill in the art will understand that other arrangements can be used. For example, the peritoneal dialysis cassette 101 can be loaded from the top or side of the peritoneal dialysis cycler 702. The receiving compartment can be vertical, horizontal, or at any type of angle.

[0096] In some embodiments, the peritoneal dialysis cycler 702 can include a user interface 705. The user interface 705 can, in some embodiments, be used to control treatment and provide messages to the user. As illustrated in FIG. 7A, in some embodiments, the user interface 705 can be moveable. The user interface 705 can be hinged or otherwise connected to the peritoneal dialysis cycler 702 to allow the user interface 705 to move.

[0097] In addition to loading of the peritoneal dialysis cassette 101, the door 706 or top 704 can be opened to give access to peritoneal dialysis cycler 702 components for maintenance, repair, or replacement, or to connect one or more patient lines, drain lines, or containers to the peritoneal dialysis cycler 702.

[0098] FIG. 7B illustrates a peritoneal dialysis cassette chamber within the receiving slot of the peritoneal dialysis cycler 702. In some embodiments, a front surface 701 of the peritoneal dialysis cassette chamber can contact the membrane side of the peritoneal dialysis cassette.

[0099] As described, the first and second pump chambers of a diaphragm pump within the peritoneal dialysis cassette can engage with a first pneumatic surface 707 and a second pneumatic surface 708 of the peritoneal dialysis cycler 702, respectively. When air is pumped into and out of pneumatic chambers (not shown in FIG. 7B) behind the first pneumatic surface 707 and second pneumatic surface 708, the pump chambers of the diaphragm pump can expand and contract tomove fluid through the peritoneal dialysis cassette. The first pneumatic surface 707 and second pneumatic surface 708 can each include a plurality of openings to allow positive or negative pressure within the pneumatic chambers to pump the diaphragm pump.[000100] The front surface 701 of the peritoneal dialysis cassette chamber can include multiple locations for controlling pinch valves, each connected to a separate pneumatic system and pneumatic manifold than the first pneumatic surface 707 and second pneumatic surface 708 for operating the diaphragm pump. As described, fluid movement through the peritoneal dialysis cassette can be controlled by one or more pinch valves. As illustrated in FIG. 7B, in some embodiments, the system can include a first valve surface 709, a second valve surface 710, a third valve surface 711, a fourth valve surface 712, a fifth valve surface 713, a sixth valve surface 714, a seventh valve surface 715, an eighth valve surface 716, a ninth valve surface 717, a tenth valve surface 718, an eleventh valve surface 719, a twelfth valve surface 720, a thirteenth valve surface 721, a fourteenth valve surface 722, and a fifteenth valve surface 723. However, the valve arrangement shown in FIG. 7B is for illustrative purposes only, and other valve arrangements with more or fewer valves can be used depending on the needs of the user and system. In some embodiments, a control system (not shown in FIG. 7B) can operate the pneumatic system to provide or withdraw pressure from each of the valve surfaces to operate the pinch clamps and selectively direct fluid through the peritoneal dialysis cassette.[000101] In some embodiments, one or more pressure sensors can be included, such as pressure sensor 724 and pressure sensor 725. Pressure sensor 724 and pressure sensor 725 can contact the membrane side of the peritoneal dialysis cassette. Fluid moving through the fluid passages of the peritoneal dialysis cassette can contact the membrane and exerts force outwardly, which can be measured by pressure sensor 724 and pressure sensor 725.[000102] FIG. 7C is shows a cross-section of the peritoneal dialysis cycler 702 including the receiving compartment 730 for a peritoneal dialysis cassette, according to an embodiment. The peritoneal dialysis cassette (not shown) can be placed within the receiving compartment 730 as described. When properly loaded, a pump chamber of the diaphragm pump will be aligned with pneumatic surface 708 of the peritoneal dialysis cycler 702. In some embodiments, a control system can operate one or more valves in a pneumatic manifold to control the pressure withinpneumatic chamber 728 behind pneumatic surface 708 to control the diaphragm pump. Air can be pumped from the pneumatic manifold into or out of the pneumatic chamber 728 through air line 726.[000103] As described, the peritoneal dialysis cycler can also include a pressure sensor 725 to measure the fluid pressure within the peritoneal dialysis cassette. The pressure sensor 725 can determine the force exerted by fluid on the membrane of the peritoneal dialysis cassette 101 and transmit the information to the control system through wire 729. In some embodiments, the information can be transmitted by any wireless methods. Door 706 on the front of the peritoneal dialysis cycler 702 can be opened for loading of the peritoneal dialysis cassette or to give access to peritoneal dialysis cycler 702 components for maintenance, repair, or replacement, or to connect one or more patient lines, drain lines, or containers to the peritoneal dialysis cycler 702.[000104] In some embodiments, the peritoneal dialysis cycler 702 can include a gasket (not shown in FIG.’s 7A-C) for contact with the peritoneal dialysis cassette. The gasket can ensure proper sealing of the door side of the peritoneal dialysis cycler 702 with the peritoneal dialysis cassette 101. In some embodiments, a pneumatic balloon (not shown) on the door of the peritoneal dialysis cycler 702 can be included to pressure seal the cassette, eliminating leakage from the sides of the cassette. The gasket for contact with the peritoneal dialysis cassette can be concave, matching the concavity of the flexible surface of the peritoneal dialysis cassette. A concave gasket can, in some embodiments, cause a spherical volume when the surfaces are mated, reducing fatigue on the surfaces by reducing the distance the surface must travel in comparison with a surface to surface mating.[000105] FIG.’s 8A-B illustrate an alternative type of peritoneal dialysis cassette. An exploded view of the peritoneal dialysis cassette is shown in FIG. 8A, while a top view of the peritoneal dialysis cassette is shown in FIG. 8B.[000106] As illustrated in FIG. 8A, the peritoneal dialysis cassette 101 of FIG.’s 8A-B can include a first flexible surface 802 and a second flexible surface 803. The first flexible surface 802 and second flexible surface 803 are on each side of a rigid body 801. In some embodiments, the top flexible surface 802 includes concave portion 804 aligned with pumping chamber 806, andconcave portion 805 aligned with pumping chamber 807. The bottom flexible surface 803 can be substantially flat.[000107] Pumping of fluid through the fluid passages of the peritoneal dialysis cassette ofFIG.’s 8A-B can be similar to that described with respect to the peritoneal dialysis cassette 101 illustrated in FIG.’s 1-2. A pneumatic surface of the peritoneal dialysis cycler, including a plurality of openings, can contact concave portion 804 and concave portion 805. In some embodiments, application of positive or negative pressure in a pneumatic chamber behind the pneumatic surfaces can cause pumping of the diaphragm pump by expanding or contacting pumping chamber 806 and pumping chamber 807.[000108] As described, the peritoneal dialysis cassette 101 can include one or more inlet / outlet ports. In some embodiments, the peritoneal dialysis cassette 101 can include a first inlet / outlet port 808 used for automatic sampling of the peritoneal dialysate, a second inlet / outlet port 809 used for a drain line, a third inlet / outlet port 810 for the connection with a patient line, a fourth inlet / outlet port 811 used to connect to a heating bag line, a fifth inlet / outlet port 812 for a first pre-filled bag connection, a sixth inlet / outlet port 813 for a second pre-filled bag connection, and a seventh inlet / outlet port 814 for a third pre-filled bag connection. However, the peritoneal dialysis cassette 101 can include any number of inlet / outlet ports, including more or fewer inlet / outlet ports than illustrated in FIG.’s 8A-B depending on the needs of the user and system. As illustrated in FIG.’s 8A-B, in some embodiments, all of the inlet / outlet ports can be positioned on a single edge of the peritoneal dialysis cassette. In some embodiments, more than one edge of the peritoneal dialysis cassette 101 can include one or more inlet / outlet ports.[000109] In some embodiments, to control the movement of fluid through the peritoneal dialysis cassette 101, one or more valves (not shown) connected to a pneumatic system can be included on the peritoneal dialysis cycler. In some embodiments, the valves can extend or retract as described to occlude specific passageways through the peritoneal dialysis cassette. For clarity, only a single passageway 815 is labeled in FIG. 8A. In some embodiments, a valve can be extended as described to push flexible surface 802 against the rigid body 801, thus preventing fluid from moving through passageway 815.[000110] FIG. 8B shows a top view of the peritoneal dialysis cassette shown in FIG. 8A. The peritoneal dialysis cassette 101 can include a rigid body 801 covered by a first flexible surface 802. A second flexible surface (not shown in FIG. 8B) can be included on the bottom side of the rigid body 801. The rigid body can include a first pump chamber 806 and second pump chamber 807 covered by concave portions (not visible in FIG. 8B) of the first flexible surface 802. A plurality of occludable fluid passages can be included for directing fluid through the peritoneal dialysis cassette 101, including fluid passage 815, fluid passage 816, fluid passage 817, fluid passage 818, fluid passage 819, fluid passage 820, fluid passage 821, fluid passage 822, fluid passage 823, fluid passage 824, fluid passage 825, fluid passage 826, fluid passage 827, and fluid passage 828. These fluid passages can connect the plurality of inlet / outlet ports through the first pump chamber 806 and second pump chamber 807, in some embodiments. As described, in some embodiments, a pneumatic valve system can be included to control which fluid passages fluid will travel through, allowing selective directing of fluid from a first specified inlet / outlet port to a second specified inlet / outlet port.[000111] In some embodiments, one or more pressure sensing regions can be included in the peritoneal dialysis cassette, such as pressure sensing region 829. The flexible surface 802 above pressure sensing region 829 can be in contact with pressure sensors that can measure the force exerted on the flexible surface by fluid moving through the peritoneal dialysis cassette. As described, in some embodiments, the peritoneal dialysis cassette 101 can include multiple pressure sensing regions.[000112] 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. Various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. Moreover, features illustrated or described as being part of an aspect of the disclosure may be used in the aspect of the disclosure, either alone or in combination, or follow a preferred arrangement of one or more of the described elements. Depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., certain described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described asperformed by a single module or unit for purposes of clarity, the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

Claims

WHAT IS CLAIMED IS:

1. A peritoneal dialysis cycler, comprising: at least a first and a second pneumatic surface, each of the at least first and second pneumatic surfaces having a plurality of openings from the pneumatic surface to a first pneumatic chamber and second pneumatic chamber, respectively; and a pneumatic source connected to each of the first pneumatic chamber and second pneumatic chamber, the pneumatic source configured to apply positive or negative pressure in the first pneumatic chamber and second pneumatic chamber.

2. The peritoneal dialysis cycler of claim 1; further comprising a first and second gasket connectable to the first and second pneumatic surfaces, respectively, the first and second gasket connectable to first and second pump chambers of a diaphragm pump of a peritoneal dialysis cassette.

3. The peritoneal dialysis cycler of claim 2; wherein each of the first and second gaskets have openings.

4. The peritoneal dialysis cycler of claim 3, wherein the openings of the first and second gaskets are aligned with the openings on the first and second pneumatic surfaces.

5. The peritoneal dialysis cycler of claim 3, wherein the openings of the first and second gaskets are misaligned with the openings on the first and second pneumatic surfaces.

6. The peritoneal dialysis cycler of claim 2; wherein each of the first and second gaskets have a solid surface for contact with the first and second pneumatic surfaces.

7. The peritoneal dialysis cycler of claim 1; wherein the first and second pneumatic surfaces are connectable to first and second pump chambers of a diaphragm pump of a disposable cassette.

8. The peritoneal dialysis cycler of claim 7; wherein application of positive or negative pressure in the first and second pneumatic chamber cause pumping of the diaphragm pump.

9. A system, comprising: a) a peritoneal dialysis cycler; the peritoneal dialysis cycler comprising:at least a first and a second pneumatic surface, each of the at least first and second pneumatic surfaces having a plurality of openings from the pneumatic surface to a first pneumatic chamber and second pneumatic chamber, respectively; each of the first pneumatic chamber and second pneumatic chamber connected to a pneumatic source; the pneumatic source operable to apply positive or negative pressure in the first pneumatic chamber and second pneumatic chamber; and b) a peritoneal dialysis cassette; the peritoneal dialysis cassette comprising: at least a first flexible surface and a second surface; a diaphragm pump having at least a first pump chamber and second pump chamber; wherein the first and second pump chambers are connectable to the first and second pneumatic surfaces, respectively; and a plurality of fluid passages between the first flexible surface and the second surface, the plurality of fluid passages fluidly connected to the first pump chamber and second pump chamber and to a plurality of inlet / outlet ports.

10. The system of claim 9; wherein the second surface is a rigid surface.

11. The system of claim 9; wherein the second surface is a flexible surface, and wherein the peritoneal dialysis cassette comprises a rigid body between the first flexible surface and the second flexible surface.

12. The system of claim 9, further comprising a plurality of pinch clamps, the plurality of pinch clamps operable to occlude one or more of the plurality of fluid passages.

13. The system of claim 12, wherein the plurality of pinch clamps are operable by a second pneumatic source.

14. The system of claim 9, further comprising a control system; the control system programmed to control a first and a second solenoid valve to control pumping of fluid through the peritoneal dialysis cassette.

15. The system of claim 9, further comprising a first gasket between the first pump chamber and the first pneumatic surface.

16. The system of claim 15, further comprising a second gasket between the second pump chamber and the second pneumatic surface.

17. The system of claim 16, wherein each of the first and second gaskets have openings.

18. The system of claim of claim 17, wherein the openings of the first and second gaskets are aligned with the openings on the first and second pneumatic surfaces.

19. The system of claim of claim 17, wherein the openings of the first and second gaskets are misaligned with the openings on the first and second pneumatic surfaces.

20. The system of claim of claim 17, wherein each of the first and second gaskets have a solid surface for contact with the first and second pneumatic surfaces.

21. The system of claim 9, wherein application of positive or negative pressure in the first and second pneumatic chamber cause pumping of the diaphragm pump.

22. The system of claim 9, wherein the first and second pump chambers are symmetrical circular chambers.

23. The system of claim 9, wherein the first flexible surface has first and second concave portions aligned with the first and second pump chambers.

24. The system of claim 9, wherein the plurality of inlet / outlet ports are all on a single edge of the peritoneal dialysis cassette.

25. The system of claim 9, further comprising a gasket on the peritoneal dialysis cycler for mating with the peritoneal dialysis cassette.

Images