HK1217666B - Peritoneal dialysis systems and related devices and methods - Google Patents

Description

Peritoneal dialysis systems and related devices and methods

Technical Field

The present invention relates to peritoneal dialysis systems and related devices and methods.

Background

Dialysis is a treatment used to support patients with renal insufficiency. The two main dialysis methods are hemodialysis and peritoneal dialysis.

During hemodialysis ("HD"), the patient's blood passes through the dialyzer of the dialysis machine, while the dialysis solution or dialysate also passes through the dialyzer. The semi-permeable membrane in the dialyzer separates blood from the dialysate within the dialyzer and allows diffusion and osmotic exchanges to occur between the dialysate and the blood stream. These exchanges across the membrane result in the removal of waste products from the blood including solutes like urea, creatinine. These communications also regulate the levels of other substances in the blood, such as sodium and water. In this way, the dialysis machine acts as an artificial kidney for cleaning the blood.

During peritoneal dialysis ("PD"), the abdominal cavity of a patient is periodically infused with a dialysis solution or dialysate. The membranous inner layer of the patient's peritoneum acts as a natural semi-permeable membrane that allows diffusion and osmotic exchange to occur between the solution and the blood stream. These exchanges across the patient's peritoneum, like the continuous exchanges across the dialyzer in HD, result in the removal of waste products from the blood including solutes like urea and creatinine, and the regulation of the levels of other substances in the blood, like sodium and water.

Many PD machines, commonly referred to as "cyclers," are designed to automatically infuse, dwell, and drain dialysate into and from the patient's peritoneal cavity in a process known as "continuous cycler assisted peritoneal dialysis" (CCPD). Treatment typically lasts for several hours, often beginning with an initial drain procedure to empty the peritoneal cavity of spent or spent dialysate. Then, this is done continuously by following the sequence of injection, dwell, and discharge stages one after the other. Each phase is referred to as a cycle.

Because of the length of the treatment, the large size of the PD machine and the large volume of dialysate required for the treatment, the treatment can be performed at home while the patient is sleeping. While nighttime CCPD treatment is sufficient for some patients, during the daytime, other patients require one or more additional fluid exchanges. To permit the patient to participate in normal daily activities outdoors, Continuous Ambulatory Peritoneal Dialysis (CAPD) is performed by connecting a dialysis fluid bag to the patient's peritoneal catheter and delivering approximately 1-3 liters of dialysate to the peritoneal cavity. After allowing the dialysate to dwell in the abdominal cavity for a predetermined period of time, the dialysate will be drained from the abdominal cavity. Patients typically monitor and record the number of daytime exchanges and the amount of dialysate used during the daytime exchanges.

Disclosure of Invention

In one aspect, a peritoneal dialysis system includes a base peritoneal dialysis system and a peritoneal dialysis fluid exchange system that operates independently of the base peritoneal dialysis system. The base peritoneal dialysis system includes a first disposable unit including a first patient line configured to be connected to a patient and a peritoneal dialysis set. The peritoneal dialysis set comprises a compartment configured to receive the first disposable unit, and at least one pump arranged such that when the first disposable unit is placed within the compartment. The pump cooperates with the first disposable unit to deliver dialysate to and drain dialysate from the peritoneal cavity of the patient via the first patient tubing of the first disposable unit. The peritoneal dialysis fluid exchange system includes a second disposable unit including a second patient tubing configured to be connected to the patient such that fluid can be delivered to and drained from the patient's peritoneal cavity via the second patient tubing, and a fluid exchange device. The fluid exchange device includes a compartment configured to receive the second disposable unit, and a data exchange interface operable to transfer patient treatment data from the peritoneal dialysis fluid exchange system to the base peritoneal dialysis system.

Implementations may include one or more of the following features:

in some implementations, the base peritoneal dialysis system is configured to automatically deliver dialysate to and drain dialysate from the peritoneal cavity of the patient based on the patient treatment plan, and modify the treatment plan for the patient based on patient treatment data communicated from the peritoneal dialysis fluid exchange system.

In some implementations, the data exchange interface is a transmitter and the base peritoneal dialysis system further includes a receiver.

In some implementations, the data exchange interface is an input/output port configured to permit connection to a data communication conduit extending from the base peritoneal dialysis system.

In some implementations, the peritoneal dialysis fluid exchange system includes a fluid flow meter.

In some implementations, the fluid exchange device further includes a sensor positioned adjacent the second disposable unit when the second disposable unit is positioned in the compartment of the fluid exchange device, the sensor operable to obtain patient treatment data.

In some implementations, the patient treatment data includes a volume of fluid delivered to the patient and a volume of fluid expelled from the patient.

In some implementations, the peritoneal dialysis fluid exchange system includes a processor configured to calculate a fluid flow rate through the peritoneal dialysis fluid exchange system, calculate a duration of fluid flow through the peritoneal dialysis fluid exchange system, and determine at least one of a volume of fluid infused into the patient and a volume of fluid removed from the patient using the calculated fluid flow rate and the calculated duration.

In some implementations, the processor is further configured to store at least one of the calculated fluid flow rate, the calculated duration, the volume of fluid delivered to the patient, and the volume of fluid expelled from the patient.

In some implementations, the second disposable unit includes a base and a flexible membrane attached to the base in a manner such that the base and the flexible membrane cooperate to form a fluid passage that can be placed in communication with the second patient conduit, wherein the fluid passage includes a first pressure sensor seat, a second pressure sensor seat, and a localized area of reduced fluid passage diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

In some implementations, the second disposable unit includes a base and a flexible membrane attached to the base in a manner such that the base and the flexible membrane cooperate to form a fluid channel that can be placed in communication with the second patient conduit. The second patient conduit has a patient conduit portion connected to the infusion conduit portion and the discharge conduit portion, and the patient conduit portion includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passage diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

In some implementations, the fluid exchange device includes a first pressure sensor and a second pressure sensor, the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that the first pressure sensor is disposed in a position corresponding to the first pressure sensor seat and the second pressure sensor is disposed in a position corresponding to the second pressure sensor seat, and the fluid exchange device further includes a controller. The controller is configured to receive fluid pressure data detected by the first pressure sensor and the second pressure sensor, and to calculate fluid flow data based on the received fluid pressure data, and to send the fluid flow data to the data exchange interface.

In some implementations, the injection conduit portion includes an injection conduit portion valve seat and the discharge conduit portion includes a discharge conduit portion valve seat. Furthermore, the second disposable unit comprises a pump chamber which is interposed between the first pressure sensor receptacle and the regions where the infusion and discharge conduit portions are connected to the patient conduit portion. The fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that the fill conduit valve is disposed in a position corresponding to the fill conduit portion valve seat, the discharge conduit valve is disposed in a position corresponding to the discharge conduit portion valve seat, and the fluid pump is disposed in a position corresponding to the pump chamber, the fluid pump being configured to cooperate with the pump chamber to draw fluid within the fluid passage.

In some implementations, the injection conduit portion includes a conduit portion valve seat and the discharge conduit portion includes a discharge conduit portion valve seat. Furthermore, the second disposable unit comprises a pump chamber, which is placed between the first pressure sensor receptacle and the areas where the infusion and discharge conduit portions are connected to the patient conduit portion, and a pump rotor, which is placed in the pump chamber. The fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that the infusion line valve is disposed in a position corresponding to the infusion line portion valve seat, the discharge line valve is disposed in a position corresponding to the discharge line portion valve seat, and the induction coil is disposed in a position corresponding to the pump chamber, the induction coil being configured to drive the pump rotor to draw fluid within the fluid passage.

In some implementations, the second disposable unit includes a bypass channel that selectively permits fluid flow to be diverted to the past pump chamber.

In some implementations, the second disposable unit includes a bypass channel including a first end, a second end, and a bypass valve seat, the first end in communication with the patient conduit portion at a location between the pump chamber and a region where the infusion conduit portion and the discharge conduit portion are connected to the patient conduit portion, the second end in communication with the patient conduit portion at a location between the pump chamber and the first pressure valve seat.

In some implementations, the fluid exchange device includes a bypass valve at a location corresponding to the bypass valve seat.

In some implementations, the localized region of reduced fluid passage diameter includes an orifice plate disposed in the fluid passage, the orifice plate including an opening having a diameter that is less than an inner diameter of portions of the fluid passage on either side of the orifice plate.

In some implementations, the transmitted patient treatment data is synchronized with patient treatment data of the base peritoneal dialysis system.

In some implementations, the peritoneal dialysis fluid exchange system has a size and weight that is less than the size and weight of the base peritoneal dialysis system.

In some implementations, the peritoneal dialysis fluid exchange system weighs less than 1 pound.

In another aspect, a peritoneal dialysis device comprises: a compartment configured to receive a disposable unit comprising a patient conduit configured to be connected to a patient; at least one pump arranged such that, when the disposable unit is placed within the compartment, the pump cooperates with the disposable unit to deliver dialysate to and drain dialysate from the peritoneal cavity of the patient via the patient tubing of the disposable unit in accordance with a patient treatment plan; a data transfer interface configured to receive patient treatment data from a standalone peritoneal dialysis system, the patient data having been obtained during performance of peritoneal dialysis by the standalone peritoneal dialysis system; and a controller that automatically modifies the patient treatment plan based on the received patient treatment data.

In another aspect, a method of providing dialysis treatment includes: obtaining patient treatment data during performance of peritoneal dialysis by the first peritoneal dialysis system; transferring the obtained patient treatment data from the first peritoneal dialysis system to the second peritoneal dialysis system; and determining, using the second peritoneal dialysis system, a modified patient treatment plan based on the obtained patient treatment data communicated from the first peritoneal dialysis system, the modified patient treatment plan being performed by the second peritoneal dialysis system.

Implementations may include one or more of the following features:

in some implementations, the method includes performing peritoneal dialysis using the second peritoneal dialysis system based on the modified patient treatment plan.

In some implementations, obtaining patient treatment data includes measuring a fluid flow rate through the first peritoneal dialysis system and measuring a duration of fluid flow through the first peritoneal dialysis system.

In some implementations, obtaining patient treatment data includes measuring a fluid flow rate through the first peritoneal dialysis system and measuring a fluid flow duration through the first peritoneal dialysis system, and using the measured fluid flow rate and the measured fluid flow duration to determine at least one of a volume of fluid infused into the patient and a volume of fluid removed from the patient.

In some implementations, determining the modified patient treatment plan includes adjusting at least one of an infused volume and a removed volume in the dialysis treatment using the first peritoneal dialysis system based on a volume of fluid infused into the patient and a volume of fluid removed from the patient.

In some implementations, communicating the obtained patient treatment data is accomplished via a wireless connection between the first and second peritoneal dialysis systems.

In some implementations, communicating the obtained patient treatment data is accomplished via a wired connection between the first and second peritoneal dialysis systems.

In other aspects, a peritoneal dialysis cassette includes a base and a flexible membrane attached to the base in a manner such that the base and flexible membrane cooperate to form a fluid path having a patient line portion connected to an infusion line portion and an exhaust line portion. The fluid passage includes a first pressure sensor seat, a second pressure sensor seat, and a localized area of reduced fluid passage diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

Implementations may include one or more of the following features.

In some implementations, the peritoneal dialysis cassette includes a pump chamber positioned along a fluid path between the first pressure sensor mount and the regions where the infusion tubing portion and the discharge tubing portion are connected to the patient tubing portion.

In some implementations, the peritoneal dialysis cassette includes an induction pump at least partially disposed within the pump chamber.

In some implementations, the peritoneal dialysis cassette includes a bypass channel that selectively permits fluid flow to be diverted to the past pump chamber.

In some implementations, the peritoneal dialysis cassette includes a bypass channel including a first end, a second end, and a bypass valve seat, the first end in communication with the patient conduit portion at a location between the pump chamber and a region where the infusion conduit portion and the discharge conduit portion are connected to the patient conduit portion, the second end in communication with the patient conduit portion at a location between the pump chamber and the first pressure valve seat.

In some implementations, the localized region includes an orifice plate disposed in the fluid channel, the orifice plate including an opening having a diameter smaller than an inner diameter of portions of the fluid channel on either side of the orifice plate.

In other aspects, a peritoneal dialysis system includes a peritoneal dialysis cassette including a base and a flexible membrane attached to the base in a manner such that the base and flexible membrane cooperate to form a fluid path having a patient line portion connected to an infusion line portion and a drain line portion. The fluid passage includes a first pressure sensor seat, a second pressure sensor seat, and a localized area of reduced fluid passage diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

Implementations may include one or more of the following features.

In some implementations, the system also includes a fluid exchange device having a first pressure sensor and a second pressure sensor. The fluid exchange device is configured to support the cartridge in a manner such that the first fluid pressure sensor is disposed at a location corresponding to the first pressure sensor mount and the second fluid pressure sensor is disposed at a location corresponding to the second pressure sensor mount. The fluid exchange device further includes a controller configured to receive fluid pressure data detected by the first fluid pressure sensor and the second fluid pressure sensor and to calculate fluid flow data based on the received fluid pressure data, and a data exchange interface configured to transmit the fluid flow data to a location remote from the peritoneal dialysis device.

In some implementations, the infusion line portion includes an infusion line portion valve seat, the drain line portion includes a drain line portion valve seat, and the peritoneal dialysis cassette includes a pump chamber disposed between the first pressure sensor seat and the areas where the infusion line portion and the drain line portion are connected to the patient line portion. Furthermore, the fluid exchange device comprises an injection conduit valve at a position corresponding to the injection conduit portion valve seat, a discharge conduit valve at a position corresponding to the discharge conduit portion valve seat, and a fluid pump at a position corresponding to the pump chamber, the fluid pump being configured to cooperate with the pump chamber to draw fluid through the fluid passage.

In some implementations, the infusion tubing portion includes an infusion tubing portion valve seat, the drain tubing portion includes a drain tubing portion valve seat, and the peritoneal dialysis cassette includes a pump chamber disposed between the first pressure sensor seat and the areas where the infusion tubing portion and the drain tubing portion are connected to the patient tubing portion, and a pump rotor disposed within the pump chamber. Further, the fluid exchange device comprises an injection conduit valve at a position corresponding to the injection conduit portion valve seat, a discharge conduit valve at a position corresponding to the discharge conduit portion valve seat, and an induction coil at a position corresponding to the pump chamber, the induction coil being configured to drive the pump rotor to draw fluid through the fluid passage.

In some implementations, the peritoneal dialysis cassette also includes a bypass channel that selectively permits fluid flow to be diverted to the past pump chamber.

In some implementations, the peritoneal dialysis cassette further comprises a bypass channel comprising a first end, a second end, and a bypass valve seat, the first end in communication with the patient conduit portion at a location between the pump chamber and the region where the infusion conduit portion and the drain conduit portion are connected to the patient conduit portion, the second end in communication with the patient conduit portion at a location between the pump chamber and the first pressure valve seat.

In some implementations, the fluid exchange device includes a bypass valve at a location corresponding to the bypass valve seat.

In some implementations, the localized region of reduced fluid passage diameter includes an orifice plate disposed in the fluid passage, the orifice plate including an opening having a diameter that is less than an inner diameter of portions of the fluid passage on either side of the orifice plate.

Implementations may include one or more of the following advantages:

in some implementations, the peritoneal dialysis fluid exchange system permits CAPD while automatically measuring and recording the amount of fluid exchanged during CAPD. For example, the peritoneal dialysis fluid exchange system determines the volume of fluid delivered to and removed from the abdominal cavity during CAPD. Since the peritoneal dialysis fluid exchange system automatically measures and records the amount of fluid exchanged during CAPD, patient errors and measurement inaccuracies can be avoided during data collection.

In some implementations, the peritoneal dialysis fluid exchange system includes a small, lightweight (e.g., handheld) machine and a disposable fluid line set received within the machine. The peritoneal dialysis fluid exchange system is more portable than some conventional PD cyclers and therefore more convenient for fluid communication during the day, which is typically away from home.

In some implementations, the peritoneal dialysis fluid exchange system includes a fluid pump and a valve that permits improved dialysate flow control during CAPD. Performing CAPD using a peritoneal dialysis fluid exchange system can reduce the time required to perform delivery of fluid to the peritoneal cavity and removal of fluid from the peritoneal cavity during CAPD, and help ensure that all of the delivered fluid is subsequently removed during each cycle of CAPD.

In some implementations, a peritoneal dialysis system includes: a base PD system that implements CCPD in accordance with a patient treatment plan, and a peritoneal dialysis fluid exchange system that implements CAPD at a location remote from the base PD system. During CAPD, the peritoneal dialysis fluid exchange system automatically measures and records patient treatment data including the amount of fluid exchanged, and automatically self-communicates the patient treatment data to the base PD system. Upon receipt of the communicated patient treatment data, the base PD system updates and modifies the patient treatment plan and performs peritoneal dialysis based on the modified patient treatment plan. Once the peritoneal dialysis fluid exchange system communicates patient treatment data obtained during CAPD to the base PD system, the quality of CCPD performed by the base PD system is improved because the patient treatment plan is performed more accurately. Furthermore, during CAPD, the chances of human error during collection of patient therapy data and the transfer of the collected patient therapy data to the PD system are reduced. Other benefits include a reduced likelihood of patient overfill during CCPD because the daytime exchange volume is automatically measured and recorded by the peritoneal dialysis fluid exchange system, transferred to the base PD system, and the patient treatment plan executed by the base PD system is modified to reflect the transferred data.

Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims.

Drawings

Fig. 1 is a perspective view of a peritoneal dialysis ("PD") system that includes a PD cycler and a PD fluid exchange device capable of transmitting data to the PD cycler.

Fig. 2 is a perspective view of the PD cycler of fig. 1 positioned on top of a portable cart.

Fig. 3 is an exploded perspective view of a PD fluidics cassette for use with the PD cycler shown in fig. 2.

Fig. 4 is a schematic diagram illustrating a control and communication system within the PD system of fig. 1.

Fig. 5 is an exploded perspective view of a gravity-fed PD fluid exchange system.

Fig. 6 is a perspective view of the PD fluid exchange system of fig. 5, showing a PD fluid exchange cassette placed within an open PD fluid exchange device.

Fig. 7 is a perspective view of the PD fluid exchange system of fig. 5, showing a PD fluid exchange cassette placed within a closed PD fluid exchange device.

Figure 8 is a perspective view of the fluid exchange cartridge of figure 5.

Figure 9 is a side sectional view of the PD fluid exchange cassette of figure 5 as viewed along line 9-9 of figure 8.

Fig. 10 is an exploded perspective view of a pump-fed PD fluid exchange system.

Fig. 11 is an exploded perspective view of a PD fluid exchange system that may be gravity-fed or pump-fed.

Detailed description of the invention

Referring to fig. 1 and 2, a peritoneal dialysis ("PD") system includes a base PD system 101 and a peritoneal dialysis fluid exchange system 201. The peritoneal dialysis fluid exchange system 201 operates independently of the substrate PD system 101 and can be physically remote from the substrate PD system 101 during operation. For example, in some embodiments, the peritoneal dialysis fluid exchange system is used to provide daytime fluid exchange at work or school as part of peritoneal dialysis. The peritoneal dialysis fluid exchange system includes a peritoneal dialysis fluid exchange device (e.g., PD fluid exchange device) 202 and a simplified medical fluid cassette (e.g., fluid exchange cassette) 212. The PD fluid exchange device 202 is small and lightweight relative to the PD cycler 102 so that it can be easily transported. In some cases, the PD fluid exchange device 202 is sized to be hand-held. In addition, the PD fluid exchange device 202 includes a detector that monitors and records patient therapy data including fluid flow rates, and a data exchange interface that operably communicates the patient therapy data obtained by the PD fluid exchange device 202 to the PD cycler 102, as will be discussed in more detail below.

The substrate PD system 101 includes a PD cycler 102 and a disposable PD fluid cassette 112, such as described in pending U.S. patent application US13/442184 filed 4/9 2010, and which is incorporated herein by reference. In some embodiments, the PD cycler 102 and PD cassette 112 are used to provide a continuous cycler to assist peritoneal dialysis. Thus, the PD cycler (also referred to as a PD machine) 102 is designed for home use. Due to its size and weight, the PD cycler 102 is shown supported on a cart 104 that is used to improve ease of handling and storage of the PD cycler 102 in a home environment. The PD cycler 102 includes a housing 106, a door 108, and a cassette interface 110 that abuts the disposable PD fluidic cassette 112 when the PD fluidic cassette 112 is placed in a cassette compartment 114 formed between the cassette interface 110 and the closed door 108. A heater tray 116 is placed on top of the housing 106. The heater tray 116 is sized and shaped to fit a dialysis solution bag (e.g., a 5-liter dialysis solution bag). The PD cycler 102 also includes a display screen 118 and control buttons 120. In some embodiments, the display screen 118 is a touch screen. For example, the display screen 118 and control buttons 120 may be operated by a user (e.g., a patient) to allow for the establishment, initiation, and/or termination of PD therapy.

The dialysis solution bag 122 is hung on fingers on both sides of the cart 104, and the heater bag 124 is placed on the heater tray 116, as shown in fig. 2. The dialysis solution bag 122 and the heater bag 124 are connected to the cassette 112 via a dialysis solution bag conduit 126 and a heater bag conduit 128, respectively. During use, the dialysis solution bag tubing 126 can be used to transfer dialysis solution from the dialysis solution bag 122 to the cassette 122, and during use, the heater bag tubing 128 can be used to transfer dialysis solution back and forth between the cassette 112 and the patient. In addition, a patient line 130 and an exhaust line 132 are connected to the cassette 112. The patient tubing 130 may be connected to the abdomen of the patient via a catheter and, during use, may be used to transfer dialysis solution back and forth between the cassette 112 and the patient. The drain line 132 may be connected to a drain or drain receptacle and, during use, may be used to transfer dialysis solution from the cassette 112 to the drain or drain receptacle.

PD cycler 102 includes pistons 133A, 133B having piston heads 134A, 134B that are axially movable within piston access ports 136A, 136B formed in cartridge interface 110. The pistons 133A, 133B are connected to a motor operable to move the piston heads 134A, 134B axially inward and outward within the piston access ports 136A, 136B. As discussed below, when the cassette 112 is placed within the cassette compartment 114 of the PD cycler 102 with the door 108 closed, the piston heads 134A, 134B of the PD cycler 102 are aligned with the pump chambers 138A, 138B of the cassette 112 such that the piston heads 134A, 134B may be mechanically connected to the dome-shaped fastening members 161A, 161B of the cassette 112 that overlap the pump chambers 138A, 138B. With this arrangement, movement of the piston heads 134A, 134B toward the cassette 112 during treatment can reduce the volume of the pump chambers 138A, 138B and push dialysis solution out of the pump chambers 138A, 138B, while retraction of the piston heads 134A, 134B away from the cassette 112 can increase the volume of the pump chambers 138A, 138B and draw dialysis solution into the pump chambers 138A, 138B. Thus, the motor, pistons 133A, 133B, and piston heads 134A, 134B act as a fluid pump 140 that, in cooperation with pump chambers 138A, 138B, drives fluid through the PD cassette 112.

The PD cycler 102 also includes a plurality of inflatable members 142 disposed within inflatable member ports in the cassette interface 110. When the cassette 112 is placed within the cassette compartment 114 of the PD cycler 102, the inflatable member 142 is aligned with the depressible dome region 146 of the cassette 112. While only two inflatable members 142 and dome regions 146 are labeled in fig. 1, it should be understood that the PD cycler 102 includes an inflatable member associated with each depressible dome region 146 of the cassette 112. During use, the inflatable member 142 acts as a valve to direct the dialysis solution through the cartridge 112 in a desired manner. In particular, inflatable member 142 bulges outward beyond the surface of cartridge interface 110 when inflated and contacts depressible dome region 146 of cartridge 112, and retracts into inflatable member port 144 and out of contact with cartridge 112 when deflated. Certain fluid flow passages within the cassette 112 may be blocked by depressing their associated dome regions 146 on the cassette 112 by inflating certain inflatable members 142. Thus, by opening the piston heads 134A, 134B, PD solution can be drawn through the cassette 112, and by selectively inflating and deflating the inflatable member 142, PD solution can be directed along a desired flow path within the cassette 112.

Referring to fig. 3, the PD fluid cassette 112 is a disposable unit that includes a flexible membrane 140 attached to the periphery of a tray-like rigid substrate 156. The base 156 includes ridges 167 that extend from a generally planar surface of the base 156 toward an inner surface of the flexible membrane 140 and contact the inner surface of the flexible membrane 140 when the PD fluid cassette 112 is compressed between the door 108 and the cassette interface 110 of the PD cycler 102 to form a series of fluid channels 158 and a plurality of depressible dome regions 146 that widen portions (e.g., substantially circular widened portions) of the fluid channels 158. The fluid channel 158 fluidly connects a fluid conduit connector 160 of the PD fluid cassette 112 to the fluid pump chambers 138A, 138B, the fluid conduit connector 160 serving as an inlet/outlet port of the PD fluid cassette 112. As described above, during use, the various inflatable valve members 142 of the PD cycler 102 act on the PD fluid cassette 112. During use, dialysis solution flows into the pump chambers 138A, 138B and out of the pump chambers 138A, 138B through the fluid passage 158 and the dome region 146. At each depressible dome region 146, the membrane 140 may deflect into contact with the planar surface of the substrate 156 from which the ridges 167 extend. This contact may substantially impede (e.g., prevent) the flow of dialysis solution along the region of the channel 158 associated with the dome region 146. Thus, by selectively inflating the inflatable member 142 of the PD cycler 102, the flow of dialysate through the PD fluid cassette 112 can be controlled by selective depression of the depressible dome region 146.

The fluid conduit connectors 160 are placed along the bottom edge of the cassette 112. As described above, the fluid passageways 158 in the cassette 112 lead from the pump chambers 138A, 138B to the various connectors 160. The connector 160 is configured to receive fittings on the ends of the dialysis solution bag tubing 126, the heater bag tubing 128, the patient tubing 130, and the drain tubing 132. One end of the fitting may be inserted into and connected to its respective conduit and the other end may be inserted into and connected to its associated connector 160. By permitting connection of the dialysis solution bag line 126, the heater bag line 128, the patient line 130, and the drain line 132 to the PD fluid cassette 112, as shown in fig. 1 and 2, the connector 160 allows dialysis solution to flow into and out of the PD fluid cassette 112 during use.

Referring to fig. 4, when the substrate PD system 101 is in use, the PD fluid cassette 112 is placed in the compartment 114 of the PD cycler 102. The PC cycler 102 includes a controller 180 that controls the fluid pump 140 and the valve 142 to automatically deliver dialysate to and drain dialysate from the patient's peritoneal cavity via the patient tubing 130. In particular, the operation of the PD cycler 102 is controlled and executed by the controller 180 based on a patient treatment plan previously stored in the memory 182 in the cycler 102 of the PD. The controller 180 is operable to permit the transfer of information (e.g., instructions for performing dialysis treatment, patient treatment data, etc.) between the memory 182 and inputs or outputs for various information, including, but not limited to, the touch screen 118, the control buttons 120, and the data transfer interface 184. The memory 182 may be any form of recordable medium such as a hard disk, flash memory, RAM, or other data storage device. In some embodiments, memory 182 is non-volatile, such that it retains stored values when external power is turned off. Based on new instructions or data that have been entered by the patient via the touch screen 118 and/or the control buttons 120, or based on patient treatment data received from the PD fluid exchange system 201 via the data transfer interface 184, the controller 180 is configured to automatically modify a pre-stored treatment plan for the patient, as will be discussed further below.

Referring to fig. 5-7, PD fluid exchange system 201 includes PD fluid exchange device 202 and fluid exchange cassette 212. PD fluid exchange devices are small and light enough in weight to be easily held with one hand. For example, in some embodiments, PD fluid exchange system 201 has a weight of less than 1 pound prior to loading with fluid. As discussed further below, it contains valves, sensors and communication devices that allow it to exchange daytime fluids, as well as communicating data obtained during the exchange to the patient's home-type PD cycler 102.

The PD fluid exchange device 202 includes a housing 203 that is thin relative to its length and width. The housing 203 has a "clamshell" structure that includes a base 206 and a cover (door) 208 rotatably coupled to the base 206. The base 206 includes a bottom 216 and a sidewall 218 extending around the periphery of the bottom 216 in a direction perpendicular to the bottom 216. The bottom 216 and the sidewall 218 together define the compartment 214. Door 208 is hinged to side wall 218 along one side of housing 203 and is sized and shaped to close compartment 214. The door 208 includes a latch (not shown) that permits the door 208 to be selectively retained in the closed configuration shown in fig. 7. In some embodiments, the latch is a magnetic latch.

The inner surface of the door 208 provides a cartridge interface 210 that abuts the disposable fluid exchange cartridge 212 when the fluid exchange cartridge 212 is disposed within a cartridge compartment 214 formed in the housing 206. The PD fluid exchange device 202 includes a rigid valve member 242 disposed within a valve port in the cassette interface 210. The valve member is electrically controlled. For example, the valve member 242 may function as an armature in a solenoid (not shown). Depending on the electrical state, the solenoid is used to either advance the valve member 242 out of its respective valve port or retract the valve member into its respective valve port. When the fluid exchange cassette 212 is placed within the cassette compartment of the PD fluid exchange device 202, the valve member 242 is aligned with the depressible valve seat dome region 246 of the fluid exchange cassette 212. The PD fluid exchange apparatus 202 includes a valve member 242 associated with each valve seat dome region 246 of the fluid exchange cartridge 212. For example, in the embodiment shown in fig. 5 and 6, the PD fluid exchange device 202 includes two valve members 242 arranged to engage with respective valve seat dome regions 246 of the fluid exchange cartridge 212.

During use, the valve member 242 directs the dialysis solution through the fluid exchange cartridge 212 in a desired manner. In particular, upon activation, the valve member 242 protrudes outward beyond the surface of the cartridge interface 210 and contacts the fluid exchange cartridge 212 depressible valve seat dome region 246, and upon deflation, retracts into the valve member port 244 and does not contact the fluid exchange cartridge 212. Certain fluid flow passages within the cassette 212 may be blocked by activating certain valve members 242 to depress their associated valve seat dome regions 246 on the cassette 212. Thus, PD solution may be drawn through the cassette 212 by activating the fluid pump 250, and may be directed along a desired flow path within the fluid exchange cassette 212 by selectively advancing and retracting the valve member 242.

The cartridge interface 210 also supports a first pressure sensor 262 and a second pressure sensor 264. When the fluid exchange cartridge 212 is placed within the cartridge compartment 214 of the PD fluid exchange device 202, the first and second pressure sensors 262, 264 are aligned with and directly contact the sensor seat dome region 248 of the fluid exchange cartridge 212. This arrangement allows for detection of fluid pressure within the channels of the fluid exchange cartridge 212.

Referring again to fig. 4, the PD fluid exchange device 202 includes control buttons 220 that can be operated by a user (e.g., a patient), for example, to allow establishment, initiation, and/or termination of fluid exchange. Further, the PD fluid exchange device 202 may be battery powered or powered via a wired connection to a utility power source. While the use of battery power allows for greater activity, the use of utility power allows for relatively lower weight and cost of the device as compared to battery powered devices.

The controller 280 is provided in the PD fluid exchange device 202 that receives data from the first and second pressure sensors 262, 264 in response to the sensed fluid pressure and stores the received data on a storage medium (memory) 282 housed within the device 202. The controller 280 is configured to calculate a fluid flow rate through the fluid passageway 258 based on the detected pressure and the known orifice diameter, and is further configured to calculate a flow volume based on the calculated fluid flow rate and a duration of flow through the restriction during the injection and the exhaust. The calculated value is stored in a storage medium. For example, for each infusion or evacuation procedure, the storage medium 282 stores at least the calculated fluid flow rate, the calculated duration of fluid flow, and the volume of fluid delivered to or from the patient.

The PD fluid exchange device 202 further includes a data transfer interface 284, and the controller 280 is configured to transfer stored patient information data to the substrate PD cycler 102 via the data exchange interface 284, wherein the stored patient information data may include one or more of detected pressure, duration of flow during infusion and/or evacuation, calculated fluid flow rate, and calculated fluid volume. In some embodiments, the data transfer interface 284 communicates wirelessly with the PD cycler 102. For example, the data transfer interface 284 may use wireless standards and/or technologies, e.g.A secure wireless network, and a cellular network to communicate with the PD cycler data transfer interface 184. The time of data transfer will depend on the communication range of the wireless communication technology used. For example, if the wireless communication technology has a long range of capabilities, the transfer of data from the PD fluid exchange device 202 to the PD cycler 102 may occur when the data is acquired and/or immediately following completion of the daytime fluid exchange. If the wireless communication technology has only short range capabilities, the transfer of data from the PD fluid exchange device 202 to the PD cycler 102 may occur when the PD fluid exchange device 202 is brought within a specified range. In other embodiments, the data transfer interface 284 communicates with the PD cycler 102 using a wired connection, such as a Universal Serial Bus (USB), serial cable, or other direct connection.

Referring to fig. 8 and 9, the fluid exchange cassette 212 is a disposable unit that includes a flexible membrane 240 (not shown in fig. 8) attached to the periphery of a tray-like rigid substrate 256. The base 256 includes a ridge 267 that extends from the substantially flat surface of the base 256 toward the inner surface of the flexible membrane 240 and contacts the inner surface of the flexible membrane 240 to form a series of fluid channels when the fluid exchange cassette 212 is compressed between the door 208 and the cassette interface 210 of the fluid exchange device 202. In the fluid exchange cassette 212, the fluid passageway 258 is in the form of a "Y" shape including a patient tubing portion 258a having a bifurcation 268 where the patient tubing portion 258a transitions into a fluid supply tubing portion 258b and a fluid exhaust tubing portion 258 c. The fluid passages 258a, 258b, 258c are fluidly connected to a fluid conduit connector 260 of the fluid exchange cartridge 212, which serves as an input/output port of the fluid exchange cartridge 212.

The ridge 267 also forms two depressible valve seat dome regions 246 and two sensor seat dome regions 248, which are widened portions (e.g., substantially circular widened portions) of the fluid passage 258. Valve seat dome region 246 acts as a valve seat within fluid passageway 258. A valve seat dome region 246 is provided in each of the fluid supply line portion 258b and the fluid drain line portion 258c between the bifurcation 268 and the respective fluid conduit connector 260.

Referring again to fig. 5, at one end 252 of the fluid exchange cassette 212, the patient tubing 230 is connected to the patient tubing portion 258a via a fluid connector 260. At the opposite end 254 of the fluid exchange cartridge 212, the dialysis solution bag tubing 226 is connected to the fluid supply tubing portion 258b via a fluid connector 260, and the drain tubing 232 is connected to the fluid drain tubing portion 258c via a fluid connector 260. The patient tubing 230 may be connected to the abdomen of the patient via a catheter and, during use, may be used to transfer dialysis solution back and forth between the fluid exchange cassette 112 and the patient. The dialysis solution bag tubing 226 may be connected to the dialysis solution bag and, during use, may be used to transfer dialysis solution from the dialysis solution bag to the fluid exchange cartridge 212. The drain line 232 may be connected to a drain or drain receptacle and, during use, may be used to transfer the dialysis solution from the fluid exchange cassette 212 to the drain or drain receptacle.

The fluid exchange cassette 212 is a "gravity feed" cassette because fluid flow through the fluid exchange cassette 212 occurs under the force of gravity, while the bag of dialysis solution is placed higher than the patient and the drain or drain container is placed lower than the patient.

As described above, when the fluid exchange cassette 212 is placed within the PD fluid exchange device 202, during use, the valve member 242 of the PD fluid exchange device 202 acts on the fluid exchange cassette 212. During use, dialysis solution flows through the fluid passageway 258 and the domed regions 246, 248. At each valve seat dome region 246, the membrane 240 may deflect to contact a planar surface of the base 256 from which the ridges 267 extend. This contact may substantially impede (e.g., prevent) the flow of dialysis solution along the region of the passage 258 associated with the valve seat dome region 246. Thus, by selectively activating the valve member 242 of the PD fluid exchange device 202, the flow of dialysate through the fluid exchange cartridge 212 may be controlled by selectively depressing the valve seat dome region 246.

The sensor receptacle dome area 248 serves as a sensor receptacle within the fluid passage 258. Two sensor mount dome areas 248 are located in the patient tubing portion 258a between the bifurcation and the corresponding fluid tubing connector 260. The ridges 267 also form localized regions of reduced fluid channel diameter (e.g., regions of reduced diameter) 270. In some embodiments, the ridge 267 forms an orifice plate at this location that includes an orifice 272 having a predetermined diameter that is less than the diameter of the passage 258a adjacent the orifice plate on each side of the orifice plate. The reduced diameter region 270 is disposed in the patient tubing portion 258a between the sensor receptacle dome regions 248.

When the fluid exchange cassette 212 is placed within the PD fluid exchange device 202, a pressure sensor 262, 264 is placed in each sensor receptacle dome area 248. Pressure sensors 262, 264 sense fluid pressure within the fluid flow outside of passage 258. In particular, pressure sensors 262, 264 contact flexible membrane 240 and therefore do not directly contact fluid flowing within passage 258 during pressure sensing. Further, the arrangement of the pressure sensors 262, 264 in the sensor receptacle dome areas 248 on both sides of the reduced diameter area 270 permits measurement of the fluid pressure within the passage 258 on both sides of the reduced diameter area 270. With the known dimensions of the aperture 272, the measured pressure allows for measurement of the fluid flow rate in the patient tubing portion 258a, which corresponds to the fluid flow rate into and out of the patient during fluid exchange. Thus, the fluid exchange cassette 212 and the PD fluid exchange device 202 cooperate to form a flow meter in the PD fluid exchange system 201. The pressure-based method for measuring fluid flow rate in PD fluid exchange system 201 also allows for dynamic flow rate monitoring (e.g., measurement of fluid flow rate as the fluid flow rate changes depending on conditions) resulting in accurate flow rate measurements. Furthermore, measuring the fluid flow rate into and out of the patient and the duration of the fluid flow allows for calculation of the volume of fluid injected and expelled during the fluid exchange.

Referring to fig. 10, another PD fluid exchange system 301 includes a PD fluid exchange device 302 and a fluid exchange cassette 312. As with the previous embodiment, the PD fluid exchange device 302 is compact and light enough in weight to be easily held with one hand. In addition to including the valves, sensors, and communication devices described in the previous embodiments, PD fluid exchange system 301 includes an integrated fluid pump, as discussed below.

The fluid exchange cartridge 312 is similar to the fluid exchange cartridge 212 and in the following description, like components have common reference numerals and will not be described again. In addition to the features of the fluid exchange cartridge 212, the liquid exchange cartridge 312 also includes a pump chamber 338 disposed in the fluid passage 258 between the reduced diameter region 270 and the bifurcation 268, and a rotor assembly 354 present in the pump chamber 338. In particular, the ridge 267 forming the channel 258 has a widened portion 369 that forms the pump chamber 338. In the illustrated embodiment, pump chamber 338 is substantially larger than depressible dome region 246. The rotor assembly 354 may include a pair of rotors 356 having rotor teeth 357, and the rotors 356 are arranged such that the rotor teeth 357 are tightly meshed, thereby driving fluid through the pump chambers 338 around the periphery of the rotor teeth 357 along the inner surfaces 371 of the widened portions 369. In addition, the widened portion 369 has a peripheral shape and size that is adapted to the outer periphery of the rotor assembly 354. Because of the tight meshing of the rotor teeth and the arrangement of the pumping chamber adapted to the periphery of the rotor assembly, fluid flow through the pumping chamber 338 occurs only upon activation of the rotor assembly 354.

PD fluid exchange device 302 is similar to PD fluid exchange device 202 and in the following description, like components have common reference numerals and will not be described again. In addition to the features of PD fluid exchange device 202, PD fluid exchange device 302 further includes an actuator 352 disposed in a void formed in housing bottom 216. The activator 252 engages the rotor assembly 254 disposed within the pump chamber 238 provided in the PD fluid exchange cassette 312 to rotate the rotor 356 about the pin 355. The activator 352, together with the rotor assembly 354 and pump chamber 338, form a fluid pump 350 for drawing fluid through the PD fluid exchange cassette 312. In the illustrated embodiment, the fluid pump 350 is an inductively driven magnetic pump and the activator 352 is an induction coil that generates a rotating magnetic field for driving the rotor assembly 354. Further, the controller 280 is configured to control the direction and speed of the rotor 356 via the actuator 352.

Since the PD fluid exchange system 301 includes an integrated pump system that can pump fluid against gravity, there is no need to manually raise the dialysis solution bag and manually lower the drain relative to the patient. In addition, the rate of fluid exchange may be controlled and, in some cases, may result in faster fluid exchange than when gravity feed is used.

Referring to fig. 11, another PD fluid exchange system 401 includes a PD fluid exchange device 402 and a fluid exchange cassette 412. As with the previous embodiment, the PD fluid exchange device 402 is compact and lightweight enough to be easily held in one hand, and contains the pumps, valves, sensors and communication devices described in the previous embodiments. In addition, the PD fluid exchange system 401 also includes a bypass channel 458 to permit selection between gravity-fed fluid exchange and pump-fed fluid exchange, as discussed below.

PD fluid exchange device 402 is similar to PD fluid exchange device 302 and in the following description, like components have common reference numerals and will not be described again. In addition to the features of the PD fluid exchange device 302, the PD fluid exchange device 402 also includes an additional valve member 242 disposed within a corresponding valve member port in the cartridge interface 210. When the fluid exchange cartridge 412 is placed within the cartridge compartment 214 of the PD fluid exchange device 402, the additional valve member 442 is aligned with the depressible valve seat dome region 446 of the bypass passage 458. As with the previous embodiment, the PD fluid exchange device 402 includes a valve member 242 associated with each valve seat dome region 246 of the fluid exchange cartridge 412. For example, in the embodiment shown in fig. 11, the PD fluid exchange device 402 includes three valve members 242 arranged to engage with respective valve seat dome regions 246, 446 of the fluid exchange cartridge 412 and act as valves to direct dialysis solution through the fluid exchange cartridge 412 in a desired manner during use. By activating (e.g., advancing) the third valve member 242 to depress its associated valve seat dome region 446 on the fluid exchange cartridge 412, the bypass fluid passage 458 within the fluid exchange cartridge 412 may be blocked. When the third valve member 242 is activated to close the bypass fluid passage 458, the flow of PD solution through the fluid exchange cartridge 412 may be controlled by controlling the fluid pump 350. For example, when the fluid passage 458 is closed, operation of the actuator 352 causes fluid to flow through the pump chamber 338 and stopping the actuator 352 stops fluid flow through the fluid exchange cartridge 412. Alternatively, when the third valve member 242 is retracted to open the bypass fluid channel 458 and the activator 352 is stopped, the PD solution may be gravity fed through the fluid exchange cartridge 412 via the bypass fluid channel 458.

The fluid exchange cartridge 412 is similar to the fluid exchange cartridge 312 and in the following description, like components have common reference numerals and will not be described again. In addition to the features of the fluid exchange cassette 312, the fluid exchange cassette 412 includes a bypass channel portion 458 that selectively permits fluid flow to be diverted to the past pump chamber 338. To this end, the bypass fluid passage 458 has a first end 460 and a second end 462, the first end 460 intersecting and in fluid communication with the patient tubing portion 258a at a location between the pumping chamber 338 and the bifurcation 268, and the second end 462 intersecting and in fluid communication with the patient tubing portion 258a at a location between the pumping chamber 338 and the adjacent pressure sensor seat 248. In addition, the bypass fluid passage 458 includes a bypass valve seat 446 configured to receive a valve member, as previously discussed.

Since the fluid exchange cartridge 412 includes the bypass fluid passage 458 having the bypass valve seat 446, the PD fluid exchange system 401 may provide daytime fluid exchange, which may be gravity feed exchange or pump feed exchange.

A method of providing dialysis treatment using a medical fluid aspiration system 100 having a base PD system 101 and a peritoneal dialysis fluid exchange system 201, 301, 401 will now be described.

CAPD is performed using the peritoneal fluid exchange system 201, 301, 401 and obtains treatment data for the patient during the fluid exchange between days. In particular, during the infusion and discharge portions of the diurnal fluid exchange, the controller 280 receives sensor data detected by the fluid pressure sensors 262, 264 and determines patient therapy data corresponding to the diurnal fluid exchange. For example, based on the pressures sensed upstream and downstream of the reduced diameter region 270 and the known dimensions of the opening of the reduced diameter region 270, the controller 280 calculates the fluid flow rate within the patient tubing portion 258a of the cartridge fluid passageway 258. Based on the duration of the fluid exchange as measured by timer 290, the volume of fluid delivered and/or expelled from the patient during the fluid exchange is also calculated. In some embodiments, the patient therapy data obtained by the PD fluid exchange device 202, 302, 402 may include, but is not limited to, the pressure detected during the fluid exchange, the duration of the fluid exchange, the fluid flow rate calculated during the fluid exchange, the volume of fluid delivered to the patient during the fluid exchange, the volume of fluid expelled from the patient during the fluid exchange, the time of the fluid exchange, and the date of the fluid exchange. In some embodiments, the patient's therapy data is stored in the memory 282 of the PD fluid exchange device 202, 302, 402.

The obtained patient treatment data is transferred from the data exchange interface 284 of the peritoneal fluid exchange device 202, 302, 402 to the data exchange interface 184 of the PD cycler 102. In some embodiments, after the time delay, the obtained patient treatment data is transferred from the memory 282 of the PD fluid exchange device 202, 302, 402 to the PD cycler 102. In other embodiments, the obtained patient treatment data is transferred to the PD cycler 102 of the substrate PD system 101 while it is stored in the memory 282 of the PD fluid exchange devices 202, 302, 402. In other embodiments, the obtained patient treatment data is transferred to the PD cycler 102 of the substrate PD system 101 without being stored in the memory 282 of the PD fluid exchange devices 202, 302, 402. As previously discussed, the data transfer may be accomplished wirelessly or through a direct wired connection between the data exchange interface 284 of the PD fluid exchange device 202, 302, 402 and the data exchange interface 184 of the PD cycler 102.

The delivered patient treatment data is received by the data exchange interface 184 of the PD cycler 102 and stored in the memory 182 of the PD cycler 102. The controller 180 of the PD cycler 102 receives the transferred patient data from the data exchange interface 184 or reads the transferred patient data from the memory 182. In some embodiments, the delivered patient treatment data is synchronized with previously stored patient treatment data of the PD cycler 102, including patient treatment data obtained during CCPD using the PD cycler 102. The delivered patient treatment data may also be synchronized with a previously stored patient treatment plan. As used herein, the term "synchronize" refers to having the delivered patient treatment data inserted into the cycler memory 182 of the PD and combined with previously stored patient treatment data and other information such that a time order of all patient treatment data is obtained. Subsequently, using the base peritoneal dialysis system 101, the PD cycler controller 180 determines a modified patient treatment plan based at least in part on the obtained patient treatment data communicated from the PD fluid exchange system 201, 301, 401.

In some cases, the PD cycler controller 180 may determine that insufficient fluid exchange was performed during the diurnal fluid exchange in view of the volume of fluid infused to the patient, the volume of fluid expelled from the patient, and/or the continued fluid exchange using the peritoneal fluid exchange devices 202, 302, 402 during the diurnal fluid exchange. Thus, in this case, during the next CCPD, the PD cycler controller 180 can modify the patient treatment plan to be executed by the PD cycler 102 to correct the deficiency, e.g., by increasing the fluid exchange during the next CCPD. To correct for the insufficiency, the PD cycler controller 180 may increase the infusion volume, increase the infusion duration, decrease the drain volume, decrease the drain duration, or a combination thereof. During daytime fluid exchanges, the user may also be alerted by the machine if insufficient fluid exchanges are performed.

In other instances, the PD cycler controller 180 may determine that an excessive fluid exchange is performed during a diurnal fluid exchange in view of the volume of fluid infused into the patient, the volume of fluid expelled from the patient, and/or the continued fluid exchange using the peritoneal fluid exchange devices 202, 302, 402 during the diurnal fluid exchange. Thus, in this case, during the next CCPD, the PD cycler controller 180 can modify the patient treatment plan to be executed by the PD cycler 102 to correct for the overshoot, e.g., by reducing the amount of fluid exchange during the next CCPD. To correct for the overshoot, the PD cycler controller 180 may decrease the infusion volume, decrease the infusion duration, increase the drain volume, increase the drain duration, or a combination thereof. During daytime fluid exchanges, the user may also be alerted by the machine if an excessive fluid exchange is performed.

In other instances, in view of the volume of fluid infused into the patient, the volume of fluid expelled from the patient, and/or the continued fluid exchange using the peritoneal fluid exchange device 202, 302, 402 during a diurnal fluid exchange, the PD cycler controller 180 can determine that during the diurnal fluid exchange, the appropriate fluid exchange is performed and that during the next CCPD, no modification is made to the patient treatment plan to be performed by the PD cycler 102.

In other instances, the PD cycler controller 180 may determine that insufficient fluid is drained from the patient during diurnal fluid exchanges in view of the volume of fluid infused into the patient, the volume of fluid drained from the patient, and/or the continued fluid exchanges using the peritoneal fluid exchange devices 202, 302, 402 during diurnal fluid exchanges. Thus, in this case, during the next CCPD, the PD cycler controller 180 can modify the patient treatment plan to be executed by the PD cycler 102 to correct for insufficient fluid drainage, for example, by decreasing the amount of fluid infused during the first cycle of the next CCPD, or by increasing the drainage step prior to the first cycle of the next CCPD.

Thus, CCPD can be performed using the PD cycler 102 in accordance with the patient treatment plan including any modifications made to the plan by the PD cycler 102.

The PD cycler 102 is described herein as being operable to permit the transfer of information (e.g., treatment for performing dialysis treatment, patient treatment data, etc.) between the memory 182 and various information inputs or outputs including the data transfer interface 184. While information is discussed as being transferred from the PD fluid exchange device 202, 302, 402 to the PD cycler, information may also be transferred from the PD cycler 102 to the PD fluid exchange device 202, 302, 402. For example, in embodiments with an active aspiration mechanism, the PD cycler 102 may communicate preset parameters including, but not limited to, flow rate, pressure, fill volume, and drain volume for the PD fluid exchange devices 202, 302, 402. Advantageously, this feature minimizes the need for the patient to enter data into the PD fluid exchange device 202, 302, 402, as using the PD fluid exchange device 202, 302, 402 with the transfer information only requires inserting the fluid exchange cassette into the PD fluid exchange device, connecting the fluid bag and the catheter tubing, and opening the PD fluid exchange device 202, 302, 402. In some embodiments, all of the exchange parameters may be preprogrammed by the PD cycler 102, and the PD cycler 102 will communicate the exchange parameters to the PD fluid exchange devices 202, 302, 402. Thus, without physician-patient assistance, the PD fluid exchange devices 202, 302, 402 may automatically perform the required filling, dwelling, and draining in sequence.

The fluid pump 250 of the fluid exchange device 202 is described herein as an inductively driven magnetic pump, and the activator 252 is an induction coil that generates a rotating magnetic field for driving a rotor assembly 254 located within a fluid channel 258. This type of fluid pump is advantageous because the induction-type drive system is compact and lightweight, facilitating the small size and portability of the fluid exchange device 202, wherein the rotor assembly 254 is disposed within the fluid passageway 258. However, fluid pump 250 is not limited to an inductively driven magnetic pump. For example, fluid aspiration may be achieved using an aspiration system, such as the fluid pump 150 used in the PD cycler 102, or a peristaltic pump, where the aspiration mechanism is an external fluid channel 250.

While the PD fluid exchange device has been described as including a rigid valve member 242 that is urged outwardly from and retracted into the valve port in the cassette interface 210, the PD fluid exchange device is not limited to the use of a rigid valve member to selectively block fluid flow in the cassette fluid pathway. In one example, other mechanical devices, such as an actuatable clamp or lever, may be provided on the cartridge interface to selectively block fluid flow in the cartridge fluid channel. In another example, in the cartridge interface 210, the valve member may be an inflatable member disposed within an inflatable member port. Further, however, the rigid valve member 242 is described herein as being electrically controlled, but the valve member 242 may be activated using other methods. For example, in some embodiments, the valve member may be pneumatically or hydraulically controlled.

While the PD cycler 102 includes pistons 133A, 133B that may be mechanically connected to dome-shaped fastening members 161A, 161B of the cassette 112 that overlap pump chambers 138A, 138B, and the motor, pistons 133A, 133B, and piston heads 134A, 134B act as a fluid pump 140 that drives fluid through the PD cassette 112 in cooperation with the pump chambers 138A, 138B, the PD cycler 102 and PD cassette fluid 112 are not limited to these configurations, and the PD cycler may implement other fluid pumps and pumping systems. For example, the PD cycler 102 may include a vacuum system that cooperates with the pistons 133A, 133B and the cassette 112 to obtain a volume change within the cassette pump chambers 138A, 138B.

Although the PD cycler 102 is described in the text as being used with the PD cassette 112, the PD cycler 102 may be used with any of a variety of other types of cassettes. For example, a PD fluid cassette of PD fluid cassettes may alternatively have more or less than two pump chambers. For another example, a PD fluidic cassette may be formed from a rigid frame with a flexible membrane on each opposing side of the frame. Further, in some embodiments, the PD cycler may be of a type that does not use a cassette.

While the substrate PD system 101 including the PD cycler 102 and the PD cassette 112 is described as being designed for home use, it should be understood that these devices may be used elsewhere, such as in a clinic.

Although the PD fluid exchange device 202 is described herein as being compact and lightweight enough to be easily held in one hand, in some embodiments, the PD fluid exchange device may not be easily held in one hand, but is still more portable than a PD cycler.

While the PD fluid exchange device 202 is described herein as employing a pressure-based flow meter including an orifice plate 270 and corresponding sensors 262, 264 to measure flow rate, the PD fluid exchange device is not limited to this flow rate measurement configuration and may include other techniques and/or configurations to measure flow rate. In some embodiments, other flow restricting structures, such as venturi nozzles, may be placed between the pressure sensors 262, 264. In other embodiments, mechanical or optical flow meters may be employed to measure the flow rate in the fluid channel. In other embodiments, the flow meter may be omitted and fluid flow may be measured indirectly, for example by tracking the rotation of the rotor 356 and calculating the flow rate based on the known volume displaced by the movement of the rotor 356 within the pump chamber 338.

The PD fluid exchange cassette is described herein as including a flexible membrane 240 attached to the periphery of a rigid substrate 256. In some embodiments, to compensate for the presence of ridges defining the fluid channels, the rigid substrate may be formed with a slightly raised outer rim (not shown) to which the membrane 240 is then attached. The arrangement of attaching the membrane 240 around the peripheral edge of the rigid substrate 256 is advantageous because the periphery of the rigid substrate 256 is generally regular in shape and therefore more easily sealed. However, in some embodiments, the membrane 240 may be attached to ridges that define fluid channels.

Although PD system 100 has been described herein as being used to perform peritoneal dialysis, the system may be used in other fluid pumping applications, including but not limited to hemodialysis. For example, the PD system 100 may be used in any application requiring a portable device that is capable of cleanly and accurately aspirating fluids.

While many of the systems described above have been described for pumping dialysis solution, other types of dialysis fluid may be pumped through the cassette. As an example, where the cassette is used with a hemodialysis machine, blood may be drawn through the cassette. In addition, a priming solution, such as saline, may similarly be pumped through the cartridge using a variety of different systems and techniques described above. Similarly, as an alternative dialysis fluid, any of a variety of other types of medical fluids may be drawn through the cassette described above, depending on the type of medical fluid extractor with which the cassette is used.

A number of embodiments have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other embodiments are within the scope of the following claims.

Claims (20)

1. A peritoneal dialysis system comprising a base peritoneal dialysis system and a peritoneal dialysis fluid exchange system that operates independently of the base peritoneal dialysis system, wherein

The base peritoneal dialysis system comprises a first disposable unit comprising a first patient line configured to be connected to a patient, and a peritoneal dialysis set comprising a compartment configured to receive the first disposable unit and at least one pump arranged such that when the first disposable unit is placed within the compartment, the pump cooperates with the first disposable unit to deliver dialysate to and drain dialysate from the peritoneal cavity of the patient via the first patient line of the first disposable unit,

the peritoneal dialysis fluid exchange system having a size and weight less than the size and weight of the base peritoneal dialysis system, the peritoneal dialysis fluid exchange system comprising a second disposable unit and a fluid exchange device, the second disposable unit comprising a second patient tube and at least one valve seat, the second patient tube configured to be connected to a patient such that fluid can be delivered to and drained from the patient's peritoneal cavity via the second patient tube, the fluid exchange device sized to be handheld, comprising

A compartment configured to receive the second disposable unit,

at least one valve member arranged to cooperate with at least one valve seat of the second disposable unit when the second disposable unit is arranged in the compartment, an

A data exchange interface operable to transfer patient treatment data from the peritoneal dialysis fluid exchange system to the base peritoneal dialysis system, an

The base peritoneal dialysis system is configured to

Automatically delivering dialysate to and draining dialysate from the patient's peritoneal cavity based on the patient treatment plan, and

modifying the patient treatment plan based on the patient treatment data communicated from the peritoneal dialysis fluid exchange system.

2. The peritoneal dialysis system of claim 1, wherein the fluid exchange device further comprises a sensor.

3. The peritoneal dialysis system of claim 1, wherein the data exchange interface is a transmitter, and the base peritoneal dialysis system further comprises a receiver.

4. The peritoneal dialysis system of claim 1, wherein the data exchange interface is an input/output port configured to permit connection to a data communication conduit extending from the base peritoneal dialysis system.

5. The peritoneal dialysis system of claim 1, wherein the peritoneal dialysis fluid exchange system includes a fluid flow meter.

6. The peritoneal dialysis system of claim 1, wherein the fluid exchange device further includes a sensor disposed adjacent the second disposable unit when the second disposable unit is disposed in the compartment of the fluid exchange device, the sensor operable to obtain the patient treatment data.

7. The peritoneal dialysis system of claim 1, wherein the patient treatment data includes a volume of fluid delivered to the patient and a volume of fluid expelled from the patient.

8. The peritoneal dialysis system of claim 1, wherein the peritoneal dialysis fluid exchange system comprises a processor configured to

Calculating a fluid flow rate through the peritoneal dialysis fluid exchange system,

calculating the duration of fluid flow through the peritoneal dialysis fluid exchange system, and

determining injection of the fluid using the calculated fluid flow rate and the calculated duration

At least one of a volume of fluid of a patient and a volume of fluid expelled from the patient.

9. The peritoneal dialysis system of claim 8, wherein the processor is further configured to store at least one of the calculated fluid flow rate, the calculated duration, the volume of fluid delivered to the patient, and the volume of fluid expelled from the patient.

10. The peritoneal dialysis system of claim 8, wherein the second disposable unit comprises

A substrate, and

a flexible membrane attached to the base in a manner such that the base and the flexible membrane cooperate to form a fluid channel that can be placed in communication with the second patient conduit,

wherein the content of the first and second substances,

the fluid passage includes a first pressure sensor seat, a second pressure sensor seat, and a localized area of reduced fluid passage diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

11. The peritoneal dialysis system of claim 1, wherein the second disposable unit comprises

A base part, and

a flexible membrane attached to the base in a manner such that the base and the flexible membrane cooperate to form a fluid passageway that can be placed in communication with the second patient conduit having a patient conduit portion connected to an infusion conduit portion and an exhaust conduit portion,

wherein the content of the first and second substances,

the patient tubing portion includes a first pressure sensor seat, a second pressure sensor seat, and a localized area of reduced fluid passage diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

12. The peritoneal dialysis system of claim 11,

the fluid exchange device includes a first pressure sensor and a second pressure sensor,

the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that the first pressure sensor is disposed in a position corresponding to the first pressure sensor seat and the second pressure sensor is disposed in a position corresponding to the second pressure sensor seat, and

the fluid exchange device further comprises

A controller configured to

Receiving fluid pressure data detected by the first and second pressure sensors and calculating fluid flow data based on the received fluid pressure data, and

an interface to send the fluid flow data to the data exchange.

13. The peritoneal dialysis system of claim 12,

the injection conduit portion comprises an injection conduit portion valve seat,

the discharge conduit portion comprises a discharge conduit portion valve seat,

the second disposable unit includes a pump chamber interposed between the first pressure sensor mount and the regions where the infusion and discharge tubing portions are connected to the patient tubing portion, and the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that the second disposable unit is disposable

The injection conduit valve is placed in a position corresponding to the valve seat of said injection conduit portion,

the discharge conduit valve is disposed at a position corresponding to the discharge conduit portion valve seat, and

a fluid pump is disposed in a position corresponding to the pump cavity, the fluid pump being configured to cooperate with the pump cavity to draw fluid within the fluid passage.

14. The peritoneal dialysis system of claim 12,

the injection conduit portion comprises an injection conduit portion valve seat,

the discharge conduit portion comprises a discharge conduit portion valve seat,

the second disposable unit comprises a pump chamber disposed between the first pressure sensor mount and the regions where the infusion and discharge tubing parts are connected to the patient tubing part, and a pump rotor disposed within the pump chamber, and

the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that

The injection conduit valve is placed in a position corresponding to the valve seat of said injection conduit portion,

the discharge conduit valve is disposed at a position corresponding to the discharge conduit portion valve seat, and

an induction coil is disposed at a location corresponding to the pump chamber, the induction coil being configured to drive the pump rotor to draw fluid within the fluid passage.

15. The peritoneal dialysis system of claim 14, wherein the second disposable unit includes a bypass channel that selectively permits fluid flow to be diverted to the pump chamber in the past.

16. The peritoneal dialysis system of claim 14, wherein the second disposable unit includes a bypass channel that includes

A first end portion in communication with the patient conduit portion at a location between the pump chamber and the regions where the infusion conduit portion and the discharge conduit portion are connected to the patient conduit portion,

a second end portion at a location between the second end pump chamber and the second end first pressure valve seat, the second end portion in communication with the patient conduit portion, an

Bypassing the valve seat.

17. The peritoneal dialysis system of claim 16, wherein, in a position corresponding to the bypass valve seat, the fluid exchange device includes a bypass valve.

18. The peritoneal dialysis system of claim 11, wherein the localized region of reduced fluid channel diameter includes an orifice plate disposed in the fluid channel, the orifice plate including an opening having a diameter that is less than the inner diameter of the fluid channel portion on either side of the orifice plate.

19. The peritoneal dialysis system of claim 1, wherein the communicated patient treatment data is synchronized with patient treatment data of the base peritoneal dialysis system.

20. The peritoneal dialysis system of claim 1, wherein the peritoneal dialysis fluid exchange system weighs less than 1 pound.