CN112569418A - Automatic peritoneal dialysis circulator - Google Patents

Abstract

A peritoneal dialysis system comprising a cycler having a housing, a pump housed by the housing, the pump including an actuator and first and second valves on either side of the actuator, a fill valve housed by the housing, and a drain valve housed by the housing; and a disposable kit including a patient line configured to be positioned and arranged to operate with the pump actuator and the first and second valves, a fill line configured to be positioned and arranged to operate with the fill valve, and a drain line configured to be positioned and arranged to operate with the drain valve.

Description

Automatic peritoneal dialysis circulator

Technical Field

The present invention relates generally to medical fluid devices. More particularly, the present invention relates to peritoneal dialysis devices.

Background

The human renal system may be disabled for a variety of reasons. Renal failure can produce several physiological disorders. It is no longer possible to balance water and minerals, or to excrete daily metabolic loads. Toxic end products of metabolism, such as urea, creatinine, uric acid, and the like, may accumulate in the blood and tissues of the patient.

Reduced renal function, particularly renal failure, is treated by dialysis. Dialysis removes the normal functioning kidneys of the body and removes waste products, toxins and excess water from the body. Dialysis treatment to replace kidney function is vital to many people because the treatment is life-saving.

One type of renal failure therapy is hemodialysis ("HD"), which typically uses an osmotic gradient to remove waste products from the patient's blood. An osmotic gradient between the blood and an electrolyte solution, called dialysate or dialysate, occurs on a semi-permeable dialyzer.

Hemofiltration ("HF") is another renal replacement therapy that relies on convective transport of toxins from the patient's blood. HF is achieved by adding replacement or replacement fluids to the extracorporeal circulation during treatment. During HF treatment, the replacement fluid and the fluid accumulated by the patient between treatments are ultrafiltered, providing a convective transport mechanism that is particularly advantageous for removing neutrals and macromolecules.

Hemodiafiltration ("HDF") is a treatment modality that combines convective and osmotic clearance. HDF uses dialysate flowing through a dialyzer, similar to standard hemodialysis, to provide osmotic clearance. In addition, the replacement solution is provided directly to the extracorporeal circulation, providing convective clearance.

Most HD (HF, HDF) treatments occur in medical centers. The current trend toward home hemodialysis ("HHD") is partly because HHD can be performed daily, providing therapeutic benefits over the hemodialysis treatment of medical centers, which typically occurs twice or three times a week. Studies have shown that more frequent treatment can remove more toxins and waste products than patients who receive less frequently but are treated for longer periods of time. Patients receiving more frequent treatment do not experience a decline period as do patients in medical centers who have accumulated two to three days of toxin prior to treatment. In some regions, the nearest dialysis medical center may be many miles from the patient's home, resulting in home-to-home treatment time consuming a large portion of the day. HHD can be performed during the night or during the day while the patient relaxes, works, or otherwise appears to be productive.

Another type of renal failure therapy is peritoneal dialysis ("PD"), which infuses a dialysis solution (also called dialysate) through a catheter into the peritoneal cavity of a patient. The dialysate contacts the peritoneum of the peritoneal cavity. Waste products, toxins and excess water pass from the patient's bloodstream through the peritoneum and enter the dialysate by diffusion and osmosis, i.e. an osmotic gradient is created across the membrane. The osmotic agent in the PD dialysate provides an osmotic gradient. The spent or spent dialysate is drained from the patient, removing waste products, toxins, and excess water from the patient. The cycle is repeated, for example, a plurality of times.

There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects the implanted catheter to a drain to allow spent or spent dialysate to drain from the peritoneal cavity. The patient then switches fluid communication so that the patient catheter communicates with a bag of fresh dialysate so that fresh dialysate is infused through the catheter and into the patient. The patient disconnects the catheter from the fresh dialysate bag and allows the dialysate to settle within the peritoneal cavity, wherein transfer of waste, toxins and excess water occurs. After the dwell period, the patient repeats the manual dialysis process, for example, four times per day. Manual peritoneal dialysis requires the patient to spend a great deal of time and effort, leaving sufficient room for improvement.

Automated peritoneal dialysis ("APD") is similar to CAPD in that dialysis treatment includes drain, fill, and dwell cycles. However, APD machines typically cycle automatically while the patient is asleep. APD machines eliminate the need for patients to manually cycle treatments and transport supplies during the day. The APD machine is fluidly connected to an implanted catheter, a fresh dialysate source or fresh dialysate bag, and a fluid drain. The APD machine pumps fresh dialysate from a dialysate source through a catheter into the peritoneal cavity of a patient. The APD machine also allows dialysate to stay within the abdominal cavity for the transfer of waste, toxins and excess moisture to occur. The source may include a plurality of bags of sterile dialysate solution.

APD machines pump spent or spent dialysate from the peritoneal cavity, through a catheter, to a drain. As with manual procedures, several cycles of drain, fill, and dwell occur during dialysis. "Final fill" may occur at the end of APD treatment. The fluid may remain in the peritoneal cavity of the patient until the next treatment begins, or may be manually emptied at some point during the day.

One drawback of APDs is cost. In some parts of the world, APD machines are too expensive for most patients. Accordingly, there is a need for a low cost way of providing peritoneal dialysis treatment that can be performed while a patient is asleep, which eliminates or reduces the time and effort required for the patient to perform CAPD, while still presenting a low cost per treatment.

Disclosure of Invention

The present invention sets forth various forms of automated peritoneal dialysis ("APD") cyclers, each of which can be considered a lower cost APD cycler. In one embodiment, the cycler employs a platen pump, wherein the platen presses on the patient line, which has been mounted on the platen and held in place for pumping from the platen through a door located on the opposite side of the tube. The door opens and closes to allow patient tubes to be loaded into and removed from the cycler. The platen pump further comprises a first valve and a second valve, which valves may be pinch valves, for example, that pinch the patient tube, for example, against the door, and open to allow dialysate flow. In one embodiment, the pinch valve is an electrically driven solenoid valve that is closed, e.g., by the force of a compression spring, and energized open, such that an energized coil causes a plunger to compress the compression spring to pull the plunger away from the patient line, allowing dialysate to flow. Upon cessation of power to the coil, the compression spring is released such that the compression spring pushes shut the patient line.

The platen of the platen pump may also operate as a spring-closed, electromagnetically energized opening mechanism. In this way, both the inlet and outlet valves and the pressure plates of the pressure plate pump are fail safe, i.e., when power is lost inside the cycler or cycler, the valves and pressure plates of the pressure plate pump will close, not allowing dialysate to flow. In an alternative embodiment, the pressure plate is driven by an electric motor, such as a dc motor, which is coupled to a rotary to translational conversion device, such as a lead screw or a ball screw, to translate the pressure plate forward and backward to close and open the patient line, respectively.

Both the first valve and the second valve operate as inlet and outlet valves depending on the phase of the current cycle. If the current cycle is in the fill phase, the valve between the pressure plate and the fresh dialysate or fill container or bag is the inlet valve, and the valve between the pressure plate and the patient is the outlet valve. Conversely, if the current cycle is in the drain phase, and vice versa, such that the valve between the compression plate and the patient is the inlet valve and the valve between the compression plate and the drain receptacle or drain (if no drain bag is provided) is the outlet valve. In this manner, the platen pump is bi-directional.

In one embodiment, the platen pump operates the same regardless of the direction in which the pump is pumping. To draw dialysate (fresh or used) into a portion of the tube that operates with the pressure plate (pumping portion) for suction pop, the outlet valve is closed, and when the pressure plate is retracted from the door, the inlet valve is opened to allow the pumping portion of the patient tube to open. Fresh or used dialysate is expected to enter the pumping portion of the patient tube due to opening of the pumping portion, head pressure (head pressure) from the source (e.g., via the fill container or bag for the fill phase and the patient for the drain phase), or opening of the pumping portion and head pressure from the source due to negative pressure. To drain dialysate (fresh or used) from the pumping portion of the tube operating with the pressure plate for drain pacing, the inlet valve is closed, and when the pressure plate is extended toward the door, the outlet valve is opened to squeeze shut the pumping portion of the patient tube. For example, even if the patient is currently above the level of the cycler, the closing force of the tube will push fresh dialysate towards the patient.

In addition to the platen pump, the cycler of the present invention provides at least one fill valve and at least one drain valve. Because the cycler of the present invention is targeted for low cost, it is contemplated to provide only a single fill valve and a single drain valve. It will be appreciated, however, that multiple fill and drain valves may be provided if desired, for example, with a fill valve dedicated to each fill container or bag. In one embodiment, the fill valve and the drain valve are of the same type as a platen pump valve, such as an electrically actuated solenoid pinch valve. In one embodiment, the fill valve is positioned to operate with a fresh dialysate or fill line between containers or bags containing fresh dialysate and a "Y" or "T" connector between the fill line, patient line, and drain line. In one embodiment, the drain valve is positioned to operate with a drain line between the drain (container or home sewer) and the "Y" or "T" connector.

The cycler of the present invention also provides a housing that houses the platen pump and the various valves discussed above. The housing also houses a control unit, which may include one or more processors and one or more memories. Each of the platen pump and the valve is controlled by a control unit. A user interface is presented by the housing, which may be connected to one or more video and sound cards to provide video and sound, respectively, at the user interface and under the control of the control unit. The user interface may include a touch screen overlay and/or one or more electromechanical buttons, such as membrane switches, each operating in conjunction with the control unit to enable a user to input commands into the cycler. The housing may further comprise a battery backup controlled by said control unit to supply power to the cycler in the event of a loss of external power. The backup battery may be a rechargeable battery.

The housing also provides a heater that is controlled by the control unit, and the heater may be provided at the top of the housing so that dialysate from one or more dialysate containers (e.g., two, six liter bags) can be placed on top of the housing for heating and to provide a head height above the platen pump. In this manner, dialysate flows under positive pressure from the dialysate container to the pumping portion of the patient line. In one embodiment, fresh dialysate or fill lines extend from the respective dialysate containers to a "Y" connector, a "T" connector, or other type of manifold connector, such that a single common fresh dialysate or fill line extends from the manifold connector to the "Y" or "T" connector discussed above, which connects the single fresh dialysate or fill line, the patient line, and the drain line. The drain line may extend to a drain port or drain bag of the housing.

The following structures and features are each optional and may be added in any combination to the components of the cycler and associated disposable articles discussed above. The circulation instrument may provide a sensor, such as a bubble or air detection sensor, which outputs to the control unit, in one embodiment, presented by the housing along the patient line upstream of the platen pump, so that the control unit may stop pumping when air is detected before pumping along the patient line to the patient. Pressure sensors may also be provided, for example, as part of a platen actuator of a platen pump, or presented by the housing along a patient line between the platen pump and the patient. The pressure sensors output to a control unit that monitors the positive fluid pressure of the patient and the negative fluid pressure from the patient.

One or more load cells may also be provided, which output to the control unit for monitoring the weight of one or more fresh dialysate containers to know how much fresh dialysate has been delivered to the patient. In one embodiment, the load cell supports a heated plate on which one or more fresh dialysate containers are placed. The control unit may be programmed to monitor the output of the load cell and calculate the volume of dialysate delivered to and removed from the patient by calculating pump stroke and knowing the pump stroke volume as a cross check with the load cell output and determine the amount of additional fluid in ultrafiltration ("UF") that has been removed from the patient.

The housing may optionally include a lower compartment that holds one or more expel reservoirs. A plurality of evacuation vessels may be provided, starting from the evacuation line. The one or more drain containers are sized to hold spent dialysis solution and additional UF removed from the patient. The fresh dialysate containers, drain containers, fill lines, patient lines, one or more drain lines, and associated "Y", "T", and/or other types of manifold connectors collectively form a disposable kit.

In an alternative embodiment where separate valves are provided for each fresh dialysate container, so that the fill containers can be isolated from each other, it is contemplated to use the fresh dialysate containers as drain containers after the patient has stayed in one cycle phase, to reduce the cost of disposability, and also to weigh the spent dialysate, including the patient's UF, if one or more of said load cells are provided.

In view of the present disclosure, and not by way of limitation, the present invention (i) any structure and function of claim 1 can be combined with any structure and function of any other claim, (ii) any structure and function of claim 2 can be combined with any structure and function of any other claim, (iii) any structure and function of claim 3 can be combined with any structure and function of any other claim, (iv) any structure and function of claim 4 can be combined with any structure and function of any other claim, (v) any structure and function of claim 5 can be combined with any structure and function of any other claim, (vi) any structure and function of claim 6 can be combined with any structure and function of any other claim, (vii) any structure and function of claim 7 can be combined with any structure and function of any other claim, (viii) any structure and function of claim 8 may be combined with any structure and function of any other claim, (ix) any structure and function of claim 9 may be combined with any structure and function of any other claim, (x) any structure and function of claim 10 may be combined with any structure and function of any other claim, (xi) any structure and function of claim 11 may be combined with any structure and function of any other claim, (xii) any structure and function of claim 12 may be combined with any structure and function of any other claim, (xiii) any structure and function of claim 13 may be combined with any structure and function of any other claim, (xiv) any structure and function of claim 14 may be combined with any structure and function of any other claim, (xv) Any structure and function of claim 15 may be combined with any structure and function of any other claim, (xvi) any structure and function of claim 16 may be combined with any structure and function of any other claim, (xvii) any structure and function of claim 17 may be combined with any structure and function of any other claim, (xviii) any structure and function of claim 18 may be combined with any structure and function of any other claim, (xix) any structure and function of claim 19 may be combined with any structure and function of any other claim, (xx) any structure and function of claim 20 may be combined with any structure and function of any other claim, (xxi) any structure and function of claim 21 may be combined with any structure and function of any other claim, and (xxii) any of the structures and functions of claim 22 may be combined with any of the structures and functions of any other claim.

Furthermore, any of the structures, functions, and alternatives disclosed in connection with fig. 1-12 may be combined with any of the other structures, functions, and alternatives disclosed in connection with fig. 1-12.

In view of the present invention and the above-described aspects, it is therefore an advantage of the present invention to provide an improved APD machine.

It is another advantage of the present invention to provide an improved APD disposable.

A further advantage of the present invention is the reduction of disposable waste and cost.

Yet another advantage of the present invention is that the number of APD setup actions and steps required is reduced.

It is a still further advantage of the present invention to provide an APD machine that is efficient and cost effective to construct.

It is yet another advantage of the present invention to provide an APD machine that accurately controls the amount of fresh and spent fluid delivery and UF removal.

The advantages discussed herein may be found in one or some, but possibly not all, embodiments disclosed herein. Additional features and advantages are described herein, and will be apparent from, the following detailed description and the figures.

Drawings

Fig. 1 is a perspective view of a first main embodiment of the PD system of the invention, having a first cycler and a first disposable set.

Fig. 2 is a perspective view of the PD system of fig. 1 with the housing door open to show various components operating with the patient line of the disposable set.

Fig. 3 is a front view of one embodiment of the pump, valve and sense actuator plate of the present invention shown in fig. 2 for use with a first primary PD system, and in fig. 7 for use with a second primary PD system embodiment.

Fig. 4A and 4B are side views illustrating various embodiments of platen pump actuators of the present invention.

FIG. 5 is a perspective view of one embodiment of a first disposable set of the system shown in FIG. 1.

Fig. 6 is a perspective view of a second main embodiment of the PD system of the invention, having a second cycler and a second disposable set.

Fig. 7 is a perspective view of the PD system shown in fig. 6 with the upper housing door open to show various components operating with the patient line of the disposable set and the lower housing door open to show a location for storing the drain bag of the second primary PD system embodiment.

FIG. 8 is a perspective view of one embodiment of a second disposable set of the system shown in FIG. 6.

Fig. 9 is a perspective view illustrating one embodiment of a heater plate operable with a plurality of load cells used with either the first or second primary PD system embodiments.

Figure 10 is a schematic diagram illustrating one embodiment for incorporating first and second primary PD system embodiments into a network for tracking treatment data and downloading patient prescriptions.

Fig. 11 and 12 are schematic diagrams illustrating exemplary low-cost APD treatments that can be performed with the first and second primary PD system embodiments of the present invention.

Detailed Description

Referring now to the drawings, and in particular to fig. 1, a peritoneal dialysis ("PD") system 10a is shown. The PD system 10a includes a disposable set 20a operated by a PD cycler 50 a. The cycler 50a includes a housing 52a, and the housing 52a may be made of metal, plastic, or a combination thereof. In the illustrated embodiment, the front of the housing 52a includes a hinged door 54 (FIG. 2) and a user interface 56. The user interface 56 may include a touch screen overlay and/or one or more electromechanical buttons 58, such as membrane switches, each operating in conjunction with a control unit 60 to enable a user to input commands into the cycler 10 a. The control unit 60 as shown includes one or more processors 62 and one or more memories 64. The user interface 56 may be coupled to one or more video and sound cards 66, 68 to provide video and sound, respectively, at the user interface and under the control of the control unit 60. The cycler 10a may further include a backup battery 70, the backup battery 70 being operable with the control unit 60 to provide power to the cycler 10a when external power is lost. The backup battery 70 may be a rechargeable battery.

Fig. 1, 2 and 5 show a disposable cartridge 20 a. Suitable materials for the disposable set 20a include polyvinyl chloride ("PVC") polymers, such as those used for drain lines and drain containers (discussed below), and non-PVC polymers, such as those used for fresh dialysate containers, fill lines, and patient lines. The disposable cartridge 20a shown in figures 1, 2 and 5 has two fresh dialysate containers 22a and 22b, which may be, for example, two-liter or six-liter containers, or a combination of two-liter and six-liter containers. Alternatively, a single dialysate container is provided, or three or more fresh fluid containers are provided, and the containers are provided in other volumes. Each container 22a and 22b includes a connector 24, the connector 24 being connected to a fill line 26a and 26b, respectively. The fill lines 26a and 26b meet at a manifold connector 28, which manifold connector 28 may be a "T" connector or a "Y" connector when two fresh dialysate containers 22a and 22b are provided. If three or more dialysate containers are provided, the manifold connector 28 may have additional ports. A common fill line 26c extends from the manifold coupler 28 toward the pump of the cycler 50 a.

The common fill line 26c extends to a second connector 30, which second connector 30 may be a "Y" connector or a "T" connector. A patient line 32 extends from the second port of the "Y" or "T" connector 30. Fig. 5 shows that the patient line 32 includes a pumping portion 34, which pumping portion 34 is acted upon by a cycler 50 a. The pumping portion 34 may be a different material than the rest of the patient line 32, e.g., a harder polymer that tends to spring back to its circular shape when opened due to the force released from the portion, thereby helping to create a dialysate negative pressure through the opening. The pumping portion 34 may be slightly larger than the remainder of the patient line 32, where the remainder may be, for example, 4mm inner diameter. A drain line 36 extends from the third port of the "Y" or "T" connector 30. In the main embodiment of system 10a, drain line 36 is sized long enough to reach the patient's home sewer.

FIG. 2 shows the cycler 50a with the door 54 of the cycler 50a in an open position, exposing the cycler's actuator plate 72. Fig. 3 shows that the actuation plate 72 includes a door latch 74, the door latch 74 releasably engaging mating structure of the door 54 such that the door 54 is locked in place during pumping. The door 54 includes a latch (not shown) that releases a mating structure of the door from the door lock 74 to load the patient line 32 into an operating position and unload the patient line at the end of the treatment. In the illustrated embodiment, the door 54 rotates open and closed along one or more lower hinges (not shown). Fig. 3 also shows in more detail how the common fill line 26c connects with the patient line 32 and the drain line 36 at the "Y" or "T" connector 30.

Fig. 2 and 3 show that the cycler 50a (and cycler 50b) optionally provides an air detection sensor 76 (e.g., an air bubble or in-line air sensor) and a pressure sensor 78 at the actuation plate 72, both shown as being operable with the patient line 32. In one embodiment, the air detection sensor 76 is an ultrasonic sensor having a transmitter 76a and a receiver 76b, the transmitter 76a and the receiver 76b cooperating to sense the presence or absence of air, such as air bubbles in the pipeline. The location of the air detection sensor 76 is upstream of the pump for patient filling so that pumping can be stopped to remove air before it is pushed by the pump towards the patient. The pressure sensor 78 in the illustrated embodiment is an in-line sensor that contacts the exterior of the patient line 32 and determines the pressure by detecting the amount of force exerted on the sensor by the dialysate flowing within the patient line 32. A pressure sensor 78 is positioned between the pump and the patient in the illustrated embodiment so that positive pressure can be monitored during patient filling and negative pressure can be monitored during patient draining. The pressure sensor 78 is arranged alternately with the actuator of the pump, wherein the force provided by the pump is correlated by the control unit 60 with the pressure of the dialysis fluid flowing in the patient line 32.

In one embodiment, the closing of door 54 facilitates the operation of sensors 76 and 78. The closing of door 54 forces patient line 32 to reside within transmitter 76a and receiver 76b of air detection sensor 76. The closing 54 of the door 54 also urges the patient line 32 against the pressure sensor 78 when the pressure sensor is located at the actuation plate 72.

Both the air detection sensor 76 and the pressure sensor 78 are output to the control unit 60. If the air detection sensor 76 detects air, or if the pressure sensor 78 detects that the positive or negative pressure limit is exceeded, the control unit 60 provides an audio, visual or audiovisual alert to the patient, which may include a text or audio instruction from the user interface 56 to clear the alert, such as tapping the line to remove air or straightening the line due to an overpressure.

Fig. 2 and 3 show that the cycler 50a (and cycler 50b) provides a platen pump 80 at the actuation plate 72, which is also operable with the patient line 32. The platen pump 80 includes a platen 82, and the platen 82 may be made of metal or a strong polymer, such as teflon. The pressure plate 82 cooperates with the door 54 as shown in connection with fig. 4A and 4B. The platen pump 80 also includes a first valve 84 and a second valve 86 that operate in conjunction with the platen 82. The first and second valves 84, 86 may, for example, be pinch valves that pinch the patient tube 32 closed, e.g., against the door 54, and open to allow dialysate flow. In one embodiment, pinch valves 84 and 86 are electrically driven solenoid valves that can be closed by the force of a compression spring and energized open under the control of control unit 60 such that an energizing coil causes a plunger to compress the compression spring to pull the plunger away from patient line 32, allowing dialysate to flow. Upon cessation of power, the compression spring is released such that the compression spring pushes the patient line 32 closed against the door 54 to block dialysate flow.

Both the first valve 84 and the second valve 86 may operate as inlet and outlet valves, depending on the stage of the current treatment cycle. If the current cycle is in the fill phase, valve 84 is an inlet valve and valve 86 is an outlet valve. Conversely, if the current cycle is in the exhaust phase, and vice versa, valve 86 is the inlet valve and valve 84 is the outlet valve. In this manner, the platen pump 80 is bi-directional.

In one embodiment, the operation of the platen pump 80 is the same regardless of the direction in which the pump is pumping. To draw dialysate (fresh or used) into the pumping portion 34 of the patient line 32 for suction pacing, the outlet valve is closed, and when the pressure plate 82 is retracted from the door 54, the inlet valve is opened to allow the pumping portion 34 to open. Fresh or spent dialysate is expected to enter the pumping portion 34 via negative pressure due to opening of the pumping portion, head pressure from the source (e.g., through the fill container or bag for the fill phase, and through the patient for the drain phase), or opening of the pumping portion and head pressure from the source. The inlet valve is closed to drain dialysate (fresh or used) from the pumping portion 34 operating with the pressure plate 82, and the outlet valve opens to squeeze shut the pumping portion 34 of the patient line 32 as the pressure plate 82 extends toward the door 54. The closing force of the portion 34 pushes fresh dialysate toward the patient even if the patient is currently above the level of the cycler 50 a.

In addition to the platen pump 80, the cycler 50a (and 50b) also provides at least one fill valve 90 and at least one drain valve 92 at the actuator plate 72, the fill valve 90 and the drain valve 92 each being controlled by the control unit 60. Because the goal of the cyclers 50a and 50b is low cost, it is contemplated that only a single fill valve 90 and a single drain valve 92 be provided. It should be understood, however, that multiple fill and drain valves may be provided, if desired, such as having a dedicated fill valve 90 for each fill container or bag 22a, 22b, etc. In one embodiment, fill valve 90 and drain valve 92 are of the same type as platen pump valves 84 and 86, such as electrically actuated solenoid pinch valves. In fig. 2 and 3, the fill valve 90 is positioned to operate with a common fresh dialysate or fill line 26c, the common fresh dialysate or fill line 26c being located between the containers or bags 22a, 22b, etc. containing fresh dialysate and the "Y" or "T" connector 30 for use between the common fill line 26c, the patient line 32, and the drain line 36. In the illustrated embodiment, the drain valve 92 is positioned to operate with the drain line 36, the drain line 36 being located between the drain (container or home sewer) and the "Y" or "T" connector 30.

Fill valve 90 selectively permits or prevents access to fill containers 22a, 22b, while drain valve 92 permits or prevents access to drain line 36, and possibly to a drain container. The fill valve 90 is opened when the control unit 60 causes fresh dialysate to be delivered from the fill containers 22a, 22b to the pumping section 34. The fill valve 90 can be opened or closed when the control unit 60 causes fresh dialysate to be delivered from the pumping section 34 to the patient. The fill valve 90 can be opened or closed when used dialysate is delivered from the patient to the pumping section 34 by the control unit 60. The fill valve 90 is closed when used dialysate is delivered from the pumping section 34 to the drain line 36 by the control unit 60.

The drain 92 is closed when the control unit 60 causes fresh dialysate to be delivered from the fill containers 22a, 22b to the pumping section 34. The drain valve 92 can be opened or closed when the control unit 60 causes fresh dialysate to be delivered from the pumping section 34 to the patient. The drain valve 92 can be opened or closed when used dialysate is delivered from the patient to the pumping section 34 by the control unit 60. The fill valve 92 is opened when used dialysate is delivered from the pumping section 34 to the drain line 36 by the control unit 60.

Fig. 4A and 4B illustrate different embodiments of the platen 82 and its operation. Fig. 4A shows an embodiment in which an electromagnetic actuator 180 is provided. The electromagnetic actuator 180 includes a coil 182, with the coil 182 selectively energized as determined by the control unit 60. A housing 188 of the electromagnetic actuator 180 houses the coil 182 and the spring 184, the spring 184 being attached to a plunger 186, the plunger 186 being connected to the pressure plate 82 or integrally formed with the pressure plate 82. When the electromagnetic actuator 180 does not apply current or power to the coil 182, the spring 184 pushes the plunger 186 and the pressure plate 82 toward the door 54, closing or occluding the pumping portion 34 to expel fresh or spent dialysate. When the control unit 60 applies current or power to the coil 182, the coil 182 will generate a magnetic field around the plunger 186, causing the plunger 186 and the pressure plate 82 to move, in the illustrated case to the right, compressing the spring 184 and allowing the pumping section 34 to open and draw in fresh or spent dialysate. The housing 188 as shown may define one end of a travel stop 190, the travel stop 190 stopping the pressure plate 82 when retracted, and may be padded to reduce or attenuate the sound generated by the electromagnetic actuator 180.

Fig. 4B illustrates an embodiment in which an electric actuator 200 is provided. The electric actuator 200 includes a motor 202, such as a dc motor or a stepping motor, under the control of the control unit 60. The motor 202 includes an output shaft 204, the output shaft 204 being coupled via a coupling 206 to a rotational-to-translational conversion device 208, such as a lead screw or ball screw, to translate the pressure plate 82 forward and backward to respectively close (to push fresh or used dialysate out) and open (to pull fresh or used dialysate in) the pumping portion 34 of the patient line 32. Thus, in one embodiment, the motor 202 is bi-directional.

Although not shown, it is contemplated that the plunger 186 or rotation-to-translation conversion device 208 of the electromagnetic actuator 180 operates in conjunction with a strain gauge or other type of force or pressure sensor 80, which sends an output to the control unit 60 indicative of the force applied to the pumping portion 34 by the plunger 186 or rotation-to-translation conversion device 208. The control unit 60 converts the force measurements into dialysate pumping pressures that can be used to control the movement of the plunger 186, to control the motor 202, and/or for alarm purposes.

Referring now to fig. 6-8, the second main system 10b includes a second cycler 50b that operates the second disposable set 20 b. The cycler 50b and disposable cartridge 20b include many of the same components as discussed above with respect to the cycler 50a and disposable cartridge 20a, which are numbered identically. All of the structures, functions, and alternatives discussed above for like numbered components connected to the cycler 50a and the disposable cartridge 20a are equally applicable to the cycler 50b and the disposable cartridge 20 b. Further, FIG. 3 shows the actuation plate 72 and associated components repeated for the system 10b in FIG. 7.

The main differences between system 10b and system 10a include: an enlarged housing having an upper housing portion 52bu and a lower housing portion 52bl is provided in the system 10b and may be made of any of the materials discussed for the housing 52a of the cycler 50 a. The lower housing portion 52bl can be integrally formed (e.g., co-molded) with the upper housing portion 52bu, or the cyclers 10a and 10b themselves can be modular, with the housing 52a of the cycler 50a forming the upper housing portion 52bu of the cycler 50b and being assembled or otherwise connected to the lower housing portion 52 bl. Thus, the upper housing portion 52bu may be the same size and shape as the housing 52a of the cycler 50a and perform the same function.

As shown in fig. 7, the lower housing portion 52bl is sized to receive drain receptacles or bags 122a and 122b, and the lower housing portion 52bl includes a second door 154 that, in the illustrated embodiment, rotates open and closed, such as by one or more lower hinges, similar to the upper door 54 for accessing the actuator plate 72. In one embodiment, the lower door 154 is biased closed, for example, by one or more springs, wherein a user overcomes the biasing force to open the lower door 154. Although not shown, both the door 54 and the door 154 include or define a U-shaped opening to allow conduit access therethrough when the doors are closed flush with the remainder of the housings 52a, 52bu, and 52 bl.

Fig. 8 shows an alternative embodiment of a disposable cartridge 20 b. The alternative disposable cartridge 20b includes many of the same components as the disposable cartridge 20a, including the fill containers 22a and 22b and their connectors 24, the fill lines 26a and 26b, the manifold connector 28, the common fill line 26c, the "Y" or "T" connector 30, and the patient line 32 with the pumping portion 34. The drain line 36 extends from the "Y" or "T" connector 30 as before, but rather than extending a potentially long length to the patient's home drain, here the drain line 36 extends to a second manifold connector 128 (e.g., a "T" or "Y" connector) that branches into separate drain lines 36a and 36b for the respective drain containers 122a and 122 b.

A single large expel reservoir can alternatively be provided. However, it is contemplated that the fill containers 22a and 22b, the connector 24, the fill lines 26a and 26b, the manifold connector 28, and the common fill line 26c used for the first day treatment are used as the drain containers 122a and 122b, the connector 124, the drain lines 36a and 36b, the manifold connector 128, and the common drain line 36, respectively, for the second day treatment. In this way, the overall disposable cost is greatly reduced. Here, a new disposable set is provided in which the discharge port of the "Y" or "T" connector 30 is capped. The patient removes the cap and connects the common fill line 26c for the first day to the exhaust port of the "Y" or "T" connector 30 to complete the day's treatment. The size of the fill containers 22a and 22b should be adjusted accordingly to accommodate the removal of additional patient UF during the next day of treatment when the fill bags are used as the drain containers 122a and 122 b. After treatment, the expel reservoirs 122a and 122b and associated lines are discarded.

Fig. 9 shows an embodiment of the heating plate 94, the heating plate 94 also being shown in fig. 1, 2, 6 and 7. The heating plate 94 is sized to accommodate a plurality of fill containers 22a and 22b, such as a plurality of six liter bags, a plurality of two liter bags, and combinations thereof. In one embodiment, the heating plate 94 is made of metal, such as stainless steel or aluminum, and is heated to a body temperature of, for example, 37 ℃ by a heating coil (not shown) located below and in physical contact with the heating plate 94. The heating coils are controlled by a control unit 60.

In the illustrated embodiment, the heating plate 94 contacts, e.g., floats, on a plurality of load cells 96 a-96 d (less than four or more than four load cells may alternatively be provided). As indicated by broken lines in fig. 9, the load cells 96a to 96d are output to the control unit 60. The control unit 60 uses the outputs of the load cells 96a to 96d to determine the weight of any object on the heating plate 94. The control unit 60 knows the weight of the heating plate 94 and can subtract the weight of the heating plate 94 from the measured weight to derive the total fluid weight.

In system 10a, load cells 96 a-96 d only measure fill containers 22a and 22b because there are no drain containers 122a and 122 b. Here, UF may be measured by calculating the stroke of the platen pump 80 for dialysate delivery to and from the patient, multiplying the stroke number by the volume per stroke to determine the total volume of fresh fluid delivered and the total volume of used fluid removed, and subtracting the former from the latter to determine UF. Here, the weights determined by the load cells 96a to 96d may be used for determination of the cross-check stroke volume. Alternatively, load cells 96 a-96 d may not be needed and are therefore considered optional.

In system 10b, if desired, only fill containers 22a and 22b may be weighed, with UF determined as described for system 10 a. Alternatively, at the end of treatment, the patient or caregiver may remove the empty fill containers 22a and 22b from the heating plate 94 and then place the now filled drain containers 122a and 122b on the heating plate 94, where measurements are made so that the total weight of used fluid removed can be compared to the total weight of fresh fluid infused to determine UF removed (either alone or in combination with a stroke count volume determination for cross-checking). It should be understood that if the patient is initially full of used fluid when connected to the disposable set, the determination of UF is the period of time starting after disconnection from the cycler 50a or 50b for the previous day of treatment until disconnection from the cycler 50a or 50b for the current treatment.

A third option is not to provide the expel reservoirs 122a and 122b, but to use the currently filled reservoirs 22a and 22b as the expel reservoirs 122a and 122b in the same treatment. However, since each discharge opening requires an empty bag, the size of the bag may be limited to a filling volume size of, for example, two liters here. In addition, a valve, such as valves 90 and 92, is provided for each fill line. Each fill line then later serves as a drain valve. At the end of the treatment, the bag containing only used dialysate is weighed using load cells 96 a-96 d, wherein the control unit 60 compares the total weight of used fluid with the total weight of initial fresh fluid to determine UF. Also, the control unit 60 may perform weight calculations using the kick volume count for cross-checking.

Fig. 10 illustrates a plurality of systems 10a or 10b that may be linked to the network 100 to upload data and download updated patient treatment prescriptions at the end of a treatment. To this end, the control unit 60 is connected to the internet by wire or wirelessly, wherein a central system operating through the network 100 can be accessed. A detailed description of how to establish and manage such connections so as to avoid interrupting therapy, and how to analyze and manipulate therapy data, is described in commonly owned U.S. patent No. 10,089,443, entitled "home medical device system and method for therapy prescription and tracking, service and inventory," which is incorporated herein by reference in its entirety. The network 100 as shown includes and incorporates and/or interacts with a plurality of servers, such as machine provider servers, clinician servers, and other servers not shown, such as hospital servers and inventory managers, that allow access to a plurality of databases for a variety of purposes. Accessing the network is a significant aid and resource for patients who may be resident far from a clinic or hospital, etc. For patients who do not have access to the network, the cyclers 50a and 50b also provide a memory drive port (not shown) for receiving a portable patient storage device, such as a flash drive, for uploading treatment data from the cyclers 50a and 50b and downloading patient treatment prescriptions to the cyclers 50a and 50b via the control unit 60.

It is contemplated that flow rates of 50-250mL/min can be achieved to operate the disposable sets 20a and 20b of the cyclers 50a and 50b, respectively. The accuracy (actual versus commanded) of the operated cyclometers 50a and 50b may be about five percent in the absence of one or more load cells 96 a-96 d, and the accuracy (actual versus commanded) of the operated cyclometers 50a and 50b may be about one percent in the presence of one or more load cells 96 a-96 d. It should also be appreciated from the above description that the disposable cartridges 20a and 20b are relatively simple and easy to connect, install, and remove.

Fig. 11 and 12 illustrate two possible APD treatments performed using system 10a or 10 b. Fig. 11 shows a twelve liter APD treatment as described herein, using two six liter bags 22a and 22b loaded onto a cycler 50a or 50 b. Just before 9:00 pm, the patient will be connected to a disposable kit on a cycler, which will automatically drain to a home sewer or one of the drain bags 122a or 122b (or some to drain bags 122a and 122b), which is necessary because the last step of 7:30 am the previous day was the last fill, so that the last two liters of fluid treated previously have not been drained. After the initial drain, the patient will go through five complete fill, dwell and drain cycles (e.g., 2 liters at a time) before the last 2 liters fill (12 liters total).

Figure 12 shows an eight liter APD treatment using a single 6 liter bag 22a and a single 2 liter bag loaded onto the cycler 50a or 50b for intermediate exchange when disconnected from the cycler. Just before 10:30 of the night, the patient is connected to a disposable set on a cycler which will proceed to a home drain or automatic drain of a single drain bag 122a, which is necessary because the used fluid, which was previously manually replaced, has not been drained. After the initial drain, the patient undergoes two complete fill, dwell and drain cycles (e.g., 2 liters each) before the final 2 liters fill (6 liters total). Later in the day, for example, 6:00 PM, the patient performs a manual discharge of the last 2 liters from the 6 liter bag 22 a. The patient then had a manual single fill from a 2 liter bag.

It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims. For example, although the cycler is shown operating with a platen pump, the cycler may alternatively provide a membrane, diaphragm, or other type of volumetric pump actuator controlled by the control unit. The displacement pump actuator in embodiments also uses the first and second valves described herein. A disposable kit for a positive displacement pump actuator may include a flexible pump chamber formed by a pair of films or diaphragms that are spliced or positioned in the patient line 32 at the pumping portion 34. Further alternatively, the pump actuator may be a peristaltic pump actuator under the control of a control unit that directly drives the patient line 32 at the pumping section 34. In one embodiment, the peristaltic pump does not require a first valve and a second valve, as the peristaltic pump actuator can be configured to block flow when it is not moving to pump dialysate.

Claims (22)

1. A peritoneal dialysis cycler, comprising:

a housing;

a platen pump housed by the housing, the platen pump including a platen and first and second valves located on either side of the platen;

a fill valve housed by the housing, the fill valve being configured to operate with a fill line; and

a discharge valve housed by the housing, the discharge valve being arranged to operate with a discharge line.

2. The peritoneal dialysis cycler of claim 1, comprising a control unit configured to open the fill valve, open the first platen pump valve, the first platen pump valve being located between the platen and fill valve, close the second platen valve and withdraw the platen to draw fresh dialysate into the pumping portion of the patient line.

3. The peritoneal dialysis cycler of claim 2, wherein the control unit is further configured to close the first platen pump valve between the platen and fill valve, open the second platen valve on the opposite side of the platen from the first platen valve, and extend the platen to drain fresh dialysate out of the pumping portion of the patient line.

4. The peritoneal dialysis cycler of claim 1, comprising a control unit configured to close the first platen pump valve between the platen and the drain valve, open the second platen valve on the opposite side of the platen from the first platen valve, and withdraw the platen to draw used dialysate into the pumping portion of the patient circuit.

5. The peritoneal dialysis cycler of claim 4, wherein the control unit is further configured to open the first platen pump valve between the platen and the drain valve, open the drain valve and close the fill valve, close the second platen valve on the opposite side of the platen from the first platen valve, and extend the platen to drain spent dialysate out of the pumping portion of the patient line.

6. The peritoneal dialysis cycler of claim 1, comprising a heater positioned and arranged to heat a heated plate sized to receive at least one fresh dialysate container.

7. The peritoneal dialysis cycler of claim 1, comprising at least one load cell positioned and arranged to weigh at least one fresh or used dialysate container.

8. The peritoneal dialysis cycler of claim 1, comprising an air detection sensor positioned and arranged by the housing for operation with a patient line before the platen pump.

9. The peritoneal dialysis cycler of claim 1, comprising a dialysate pressure sensor provided with the platen pump or positioned and arranged by the housing for operation with a patient line for sensing at least one of a positive pump pressure of fresh dialysate and a negative pump pressure of used dialysate.

10. The peritoneal dialysis cycler of claim 1, wherein the housing comprises a lower compartment for holding one or more drain containers.

11. A peritoneal dialysis system, comprising:

a cycler, the cycler comprising:

a shell body, a plurality of first connecting rods and a plurality of second connecting rods,

a pump housed by the housing, the pump including an actuator and first and second valves on either side of the actuator,

a fill valve housed by the housing, an

A discharge valve housed by the housing; and

a disposable kit, the disposable kit comprising:

a patient line configured to be positioned and arranged to operate with the pump actuator, the first valve and the second valve,

a fill line configured to be positioned and arranged to operate with the fill valve, an

A drain line configured to be positioned and arranged to operate with the drain valve.

12. The peritoneal dialysis system of claim 11, wherein the disposable kit further comprises at least one drain container to which the drain line extends.

13. The peritoneal dialysis system of claim 11 wherein the disposable set further comprises at least one fresh dialysate container to which the fill line extends.

14. The peritoneal dialysis system of claim 13, wherein the cycler further comprises at least one of: a heater positioned and arranged to heat the at least one fresh dialysate container; or at least one load cell positioned and arranged to weigh the at least one fresh dialysate container.

15. The peritoneal dialysis system of claim 11, wherein the cycler further comprises at least one of: an air detection sensor positioned and arranged at the housing to operate with the fill line; or a pressure sensor positioned and arranged to detect a pressure of dialysate flowing through the patient line.

16. The peritoneal dialysis system of claim 11 wherein the disposable set further comprises a plurality of fresh dialysate containers, each fresh dialysate container in fluid communication with a fill line, each fill line coming together to be in fluid communication with a common fill line; the common fill line is the fill line configured to be positioned and arranged to operate with the fill valve.

17. The peritoneal dialysis system of claim 11, wherein the fill line is in fluid communication with a first fresh dialysate container, wherein the fill line is a first fill line and the fill valve is a first fill valve, the disposable kit further comprising: a second fill line configured to be positioned and arranged to operate with a second fill valve, and the second fill line in fluid communication with a second fresh dialysate container.

18. The peritoneal dialysis system of claim 11, wherein the pump is: (i) a platen pump, and the pump actuator includes a platen; or (ii) a volumetric pump operating with a flexible pump chamber positioned in the patient line, the flexible pump chamber being positioned and arranged to operate with the pump actuator.

19. A peritoneal dialysis system, comprising:

a cycler, the cycler comprising:

a shell body, a plurality of first connecting rods and a plurality of second connecting rods,

a pump housed by the housing, the pump including an actuator,

a fill valve housed by the housing, an

A discharge valve housed by the housing; and

a disposable kit, the disposable kit comprising:

a patient line configured to be positioned and arranged to operate with the pump actuator,

a fill line configured to be positioned and arranged to operate with the fill valve, an

A drain line configured to be positioned and arranged to operate with the drain valve.

20. The peritoneal dialysis system of claim 19, wherein the pump includes a peristaltic pump actuator for actuating the patient line.

21. The peritoneal dialysis system of claim 19, wherein the fill line is in fluid communication with a first fresh dialysate container, wherein the fill line is a first fill line and the fill valve is a first fill valve, the disposable kit further comprising a second fill line configured to be positioned and arranged to operate with a second fill valve, and the second fill line is in fluid communication with a second fresh dialysate container.

22. The peritoneal dialysis system of claim 21, wherein the cycler further includes at least one load cell positioned and arranged to weigh fresh and used dialysate located within the first and second dialysate containers.

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