Piston assembly including leak detection in a dialysis machine

Abstract

A dialysis system and a method for operating a dialysis machine (e.g., a peritoneal dialysis machine) for a dialysis treatment are disclosed. The dialysis system can include a dialysis machine for transferring dialysate from a dialysate source to a patient. The dialysate can flow from the dialysate source through a cassette or cartridge (e.g., a disposable cassette or cartridge) positionable within the dialysis machine. The dialysis machine includes a piston for pumping fluid (e.g., dialysate) from the cassette to the patient. In various embodiments, during use, the piston is arranged and configured to contact, compress, etc. a membrane defining one or more fluid chambers in the cassette. In one embodiment, the piston includes a sensor for detecting leaks at the interface between the piston and the membrane. The sensor can be a capacitive sensor.

Description

[0001] Cross-referencing of related matters

[0002] This application claims priority to U.S. Patent Application Serial No. 16 / 680,778, filed November 12, 2019, entitled “Piston Assembly Including Leak Detection in a Dialysis Machine,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to dialysis machines, and more particularly to piston assemblies in dialysis machines, the piston assemblies including leak detectors. Background Technology

[0004] As is well known, dialysis machines are used to treat kidney disease. The two main dialysis methods are hemodialysis (HD) and peritoneal dialysis (PD). During HD, the patient's blood passes through the dialyzer of the HD machine, along with dialysate. A semipermeable membrane in the dialyzer separates the blood from the dialysate within the dialyzer and allows diffusion and osmotic exchange between the dialysate and the blood flow. During PD, the patient's peritoneal cavity is periodically infused with dialysate or dialysis solution. The membranous lining of the patient's peritoneum acts as a natural semipermeable membrane, allowing diffusion and osmotic exchange between the solution and the blood flow. Automated PD machines, called PD circulators, are designed to control the entire PD process, allowing it to be performed at home, typically overnight, without the need for clinical personnel.

[0005] Dialysis machines, such as PD machines, may include one or more containers (e.g., bags) containing fluids (e.g., dialysate) for patient infusion. Additionally, PD machines may include removable and / or replaceable cartridges or cassettes (interchangeable and not intended to limit) attached to one or more fluid lines for pumping fluid to or from the patient. For example, in a PD machine, one or more fluid lines are inserted into the patient's abdomen to flow fresh dialysate and remove used dialysate, waste, and excess fluid. Because the cartridges facilitate fluid pumping, the dialysis machine can monitor fluid delivery, fluid temperature, flow path, and pressure.

[0006] During dialysis, the cartridge can be inserted into and sealed within the PD machine. At the end of the procedure, the cartridge can be removed and properly disposed of. The cartridge and associated fluid flow lines, valves, and / or connectors can be single-use items.

[0007] In use, the PD machine and cartridge include an interface where the pump mechanism of the PD machine contacts the cartridge. Specifically, the cartridge typically comprises a membrane, or for example, a rigid material forming one or more channels, pump chambers, etc., within the cartridge. The rigid material may be bonded to a flexible membrane, which can be twisted by the pump mechanism of the PD machine. Fluid (e.g., dialysate) may be contained between the rigid material and the flexible membrane. In use, the fluid (e.g., dialysate) can be moved from the PD machine to the patient via the action of a piston or pump head in the PD machine on the membrane of the cartridge.

[0008] In some cases, the cassette may have manufacturing defects; for example, the flexible membrane may not be fully bonded to the rigid material, or the flexible membrane and / or rigid material may contain holes or tears. Alternatively, the cassette may be damaged during transport, storage, insertion, etc. Regardless of the cause, in some situations, the cassette may be damaged, causing fluid (e.g., dialysate) to leak from the cassette. Cassette leakage can affect the quality of fluid flow and the exchange of dialysate with the patient, potentially impacting the patient's treatment process (e.g., dialysate may not be delivered to the patient's peritoneal cavity, or the amount of fluid delivered to or drained from the patient's peritoneal cavity may be incorrect). Furthermore, when a leak occurs in the PD machine and remains undetected, the leaked fluid may damage the PD machine, potentially irreparable, requiring complete replacement. This can be problematic when patients require frequent dialysis treatments and require immediate replacement, which can be very expensive.

[0009] Leaks occurring at the interface between the piston or pump head of the pump mechanism and the membrane near the pump chamber of the cartridge in a PD machine can be particularly problematic because the pump chamber contains one of the largest volumes of fluid collected in the cartridge. Therefore, a leak at this location can lead to a significant fluid loss. Thus, detecting leaks at or near the interface between the piston or pump head and the membrane of the cartridge is advantageous.

[0010] It is precisely because of these and other considerations that the current improvements may be useful. Summary of the Invention

[0011] The present invention is provided to introduce the selected concepts in a simplified form, which will be further described in the detailed description below. This summary is not intended to necessarily identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0012] According to an exemplary embodiment of this disclosure, a dialysis system for performing dialysis treatment is disclosed. The dialysis system includes a dialysis machine for transferring dialysate from a dialysate source to a patient. The dialysis machine includes a housing having a cavity, a pump positioned within the housing, and sensors associated with the pump. The dialysis system also includes a cartridge positionable within the cavity, the cartridge being in fluid communication with both the patient and the dialysate source; wherein, when the cartridge is positioned within the cavity, movement of the pump causes dialysate to be transferred from the dialysate source to the patient, and the sensors are arranged and configured to detect the presence of fluid.

[0013] In this embodiment and other embodiments, the sensor is a capacitive sensor arranged and configured to detect the presence of fluid.

[0014] In this embodiment and other embodiments, the capacitive sensor is located inside the pump.

[0015] In this embodiment and other embodiments, the capacitive sensor is positioned on the front surface of the pump.

[0016] In this embodiment and other embodiments, a capacitive sensor is arranged and configured to detect the presence of fluid on one of the outer surfaces of the cartridge and the front surface of the pump.

[0017] In this and other embodiments, the sensor is configured to send a signal to indicate a leak based on the detection of fluid by the sensor; wherein the signal is sent to the user interface of the dialysis machine, an audible indicator, or a visual indicator, or a combination thereof.

[0018] In this and other embodiments, the dialysis machine is arranged and configured to automatically terminate the transfer of dialysis fluid from the dialysis fluid source to the patient upon receiving a signal.

[0019] According to an exemplary embodiment of this disclosure, a method for detecting leaks in a dialysis machine is disclosed. The method includes operating the dialysis machine to transfer dialysate from a dialysate source to a patient, the dialysis machine including a housing having a cavity and a pump positioned within the housing for facilitating dialysate transfer; and monitoring the leakage condition via a leak detector, the leak detector being a capacitive sensor operatively associated with the pump, wherein the leak is detectable in response to fluid contact with the capacitive sensor.

[0020] In this embodiment and other embodiments, the capacitive sensor is disposed within the front surface of the pump, or on the front surface of the pump, or a combination thereof.

[0021] In this embodiment and other embodiments, the method further includes positioning the cartridge within the cavity, with the cartridge in fluid communication with the patient and the dialysis fluid source.

[0022] In this and other embodiments, during operation of the dialysis machine, the pump contact box and capacitive sensors are arranged and configured to detect the presence of fluid.

[0023] In this embodiment and other embodiments, a capacitive sensor is arranged and configured to detect the presence of fluid on one of the outer surfaces of the cartridge and the front surface of the pump.

[0024] In this and other embodiments, the method further includes sending a signal to the user interface, sound indicator, or light indicator, or a combination thereof, of the dialysis machine in response to fluid contact with the leak detector to indicate a leak condition.

[0025] In this embodiment and other embodiments, the method further includes automatically terminating the transfer of dialysis fluid from the dialysis fluid source to the patient upon receiving a signal.

[0026] According to an exemplary embodiment of this disclosure, a dialysis system for performing dialysis treatment is disclosed. The dialysis system includes a dialysis machine arranged and configured to transfer dialysate from a dialysate source to a patient, the dialysis machine including a housing having a cavity and a pump positioned within the housing for facilitating dialysate transfer; and a capacitive sensor operatively associated with the pump, wherein leakage of the capacitive sensor in response to fluid contact is detectable.

[0027] In this embodiment and other embodiments, the capacitive sensor is disposed within the front surface of the pump, or on the front surface of the pump, or a combination thereof.

[0028] In this and other embodiments, the dialysis system also includes a cassette that can be positioned within the cavity and is in fluid communication with the patient and the dialysate source.

[0029] In this and other embodiments, during operation of the dialysis machine, the pump contact box and capacitive sensors are arranged and configured to detect the presence of fluid.

[0030] In this embodiment and other embodiments, a capacitive sensor is arranged and configured to detect the presence of fluid on one of the outer surfaces of the cartridge and the front surface of the pump.

[0031] In this and other embodiments, in response to a leak, the dialysis machine is arranged and configured to send a signal to indicate the leak condition, the signal being sent to the dialysis machine's user interface, an audio indicator, a light indicator, or a combination thereof. Attached Figure Description

[0032] As an example, specific embodiments of the disclosed method and apparatus will now be described with reference to the accompanying drawings, in which:

[0033] Figure 1 An example of an embodiment of a dialysis system is shown;

[0034] Figure 2 It shows that it can be done Figure 1 A block diagram illustrating an example embodiment of a dialysis machine used in a dialysis system;

[0035] Figures 3A-3C It shows that it can be used Figure 1 Examples of embodiments of dialysis machines in a dialysis system;

[0036] Figure 4 It shows that it can be used with Figure 2 and Figures 3A-3C A side view of an example embodiment of a pump head according to one or more aspects of this disclosure used in conjunction with a dialysis machine; and

[0037] Figure 5 A flowchart illustrating an example of a method for detecting leaks in a dialysis machine according to an embodiment of the present disclosure is shown. Detailed Implementation

[0038] This embodiment will now be described more fully below with reference to the accompanying drawings, in which several exemplary embodiments are illustrated. However, the subject matter of this disclosure can be implemented as many different forms and types of methods and apparatuses for dialysis machines and other potential medical devices and treatments, and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to make this disclosure thorough and complete, and are intended to convey the scope of the subject matter to those skilled in the art. In the drawings, the same reference numerals consistently refer to the same elements.

[0039] Exemplary embodiments of systems and methods arranged and configured to provide improved leak detection in dialysis machines will now be described herein. Dialysis operations typically cannot be continuously monitored manually for leaks or other fluid conditions, or doing so may be inefficient or impractical. This is especially true when dialysis is performed while the patient is asleep, for example, in the case of PD machines that are often self-managed in the patient's home. Therefore, automated detection and shutdown are crucial to prevent any potential machine malfunction or improper handling.

[0040] According to one or more aspects of this disclosure, dialysis machines such as PD (dilation and repair) machines can quickly detect any leaks that may occur, for example, in a cartridge (e.g., a disposable cartridge) located within the PD machine, so that operation of the dialysis machine can be shut down, thereby ensuring patient safety and limiting or eliminating the possibility of damage or further damage to fluid-sensitive machine components (e.g., electrical and electronic components). In one example of an embodiment, the piston or pump head located in the dialysis machine includes a sensor, for example, a capacitive sensor disposed on the front surface of the piston or pump head. This sensor can detect fluid on the surface of the piston or pump head. In another example of an embodiment, the sensor may be located on or near the inlet tube of the cartridge. In some embodiments, a machine may use more than one sensor. The sensors may be located in the same or different positions relative to the pump and / or pump cartridge.

[0041] refer to Figure 1 The dialysis system 100 may include a PD machine 150 for infusing fresh dialysate into the patient and expelling used dialysate from the patient's body. During treatment, a volume of dialysate may enter the patient's abdomen and remain there for a period of time, such as a residence time. During the residence time, the dialysate may flow across the peritoneum and absorb contaminants and / or particles from the patient's blood, and exchange substances and fluids (e.g., electrolytes, urea, glucose, albumin, osmotically active particles, and other small molecules). At the end of the residence time, the used dialysate may flow out of the patient's abdomen and be purged into a drainage system connected to tubing, such as a drainage line. Depending on the patient's treatment regimen, this exchange of fresh dialysate and used dialysate after the residence time may occur over several cycles.

[0042] One or more dialysate sources may be connected to the dialysis machine 150. In some embodiments, as shown, the dialysate source may be a dialysate bag 122 suspended near the PD machine 150, which improves air content management because any air content is set to the top of the dialysate bag 122 by gravity. A valve may be attached to the bottom of the dialysate bag 122 so that fluid is withdrawn and air content delivery is minimized. In one embodiment, as shown, dialysate from the dialysate bag 122 may be directly transferred to the patient via a heated pouch, heating chamber, etc. 152 (interchangeable and not intended to limit) formed in the dialysis machine 150. When the dialysate reaches a predetermined temperature (e.g., approximately 98°–100°F, 37°C) in the heating chamber 152, the dialysate may flow into the patient. As will be described and illustrated in more detail below, the dialysate bag 122 may be connected to a box or cassette (interchangeable and not intended to limit) that can be inserted into the dialysis machine 150. In use, the cartridge may be a dialysate bag line connected to a dialysate bag 122 for transferring dialysate from the dialysate bag 122 to the cartridge. The cartridge may be disposable during use. Alternatively, the cartridge may be reusable. Furthermore, a patient line and a discharge line may be connected to the cartridge. The patient line may be connected to the patient's abdomen via a catheter and may be used to transfer dialysate back and forth between the cartridge and the patient's peritoneal cavity during use. The discharge line may be connected to a discharge system or discharge container and may be used to transfer dialysate from the cartridge to the discharge system or discharge container during use. Although the system described herein is primarily discussed in conjunction with the use of a dialysate bag as a dialysate source, it should be noted that different dialysate sources may be used in other embodiments. For example, in other embodiments, the dialysate source may include one or more containers in which dialysate is mixed from a dialysate concentrate and / or otherwise prepared in a PD circulator, see, for example, U.S. Patent No. 10,076,599 to Eyrard et al., entitled "Dry Peritoneal Dialysis Concentrate System," the entire contents of which are incorporated herein by reference.

[0043] refer to Figure 2 The diagram illustrates an exemplary embodiment of a dialysis machine, such as dialysis machine 150. Dialysis machine 150 may be a home dialysis machine, such as a PD machine, for performing dialysis treatment on a patient, and may include components described above. Figure 1 In the described system 100, the dialysis machine 150 may include a controller 155 disposed within the dialysis machine 150 during use. Alternatively, the dialysis machine 150 may be coupled to the controller 155 or other external systems via a communication port or wireless communication link. The controller 155 may automatically control the execution of treatment functions during dialysis treatment.

[0044] The controller 155 may be operatively connected to the sensor 160 and transmit signals to perform therapeutic functions (e.g., transferring dialysate from the dialysate bag 122 through the heating chamber 152 into the patient) or therapeutic procedures associated with various treatment systems. In some embodiments, a timer 165 may be included for timing the triggering of the sensor 160. The controller 155 may transmit control signals or trigger voltages to components of the dialysis machine 150 and may include a wireless communication interface. The controller 155 may detect remote devices to determine if any remote sensors are available to supplement any sensor data used for patient assessment. For example, remote devices may include smartphone microphones, cameras, thermal imaging cameras, bed sensors, sleep manager apps and sensors, webcams, fitness sensors, stand-alone sensors, etc.

[0045] In some embodiments, machine 150 may further include processor 170, memory 175, and / or controller 155, or a combination thereof, and / or machine 150 may receive signals from sensor 160 indicating various parameters. Each fluid bag (e.g., dialysate bag 122) may contain an approximate amount of dialysate, such that "approximate amount" may be defined as a 3L fluid bag containing 3000 to 3150 mL, a 5L fluid bag containing 5000 to 5250 mL, and a 6L fluid bag containing 6000 to 6300 mL. Controller 155 may also detect the connection of all connected fluid bags 122.

[0046] Communication between the controller 155 and the treatment system can be bidirectional, thereby allowing the treatment system to acknowledge control signals and / or provide status information associated with the treatment system and / or requested operations. For example, system status information may include status associated with a specific operation to be performed by the treatment system (e.g., triggering a pump to deliver dialysate, triggering a pump and / or compressor to deliver filtered blood, etc.) and status associated with a specific operation (e.g., ready to execute, executing, completed, successfully completed, queued for execution, waiting for control signals, etc.).

[0047] In some embodiments, as will be described in more detail below, the dialysis machine 150 may include at least one pump 180 operatively connected to a controller 155. During treatment, the controller 155 may control the pump 180 to pump fluids, such as fresh and used dialysate to and from the patient. The pump 180 may also pump dialysate from the dialysate bag 122 through, for example, a heating chamber 152.

[0048] The dialysis machine 150 may also include a user input interface 190, which may include a combination of hardware and software components that allow the controller 155 to communicate with external entities such as patients or other users. These components may be configured to receive information from actions, such as body movements or postures and verbal tone. In some embodiments, components of the user input interface 190 may provide information to external entities. Examples of components that may be employed within the user input interface 190 include a keypad, buttons, a microphone, a touchscreen, a gesture recognition device, a display screen, and a speaker. The dialysis machine 150 may also include a display 195 and a power supply 197.

[0049] In some embodiments, the user input interface 190 and display 195 may be, for example, a touchscreen and operable by a user (e.g., a caregiver or patient) to allow, for example, setting, initiating, and / or terminating dialysis treatment. The touchscreen and control panel may allow the operator to input various treatment parameters into the dialysis machine and otherwise control the dialysis machine. Furthermore, the touchscreen may function as a display. The touchscreen may be used to provide information to the patient and / or the operator of the dialysis system. For example, the touchscreen may display information related to the dialysis treatment to be applied to the patient, including prescription-related information. The touchscreen and / or display may include one or more buttons for selecting and / or entering user information.

[0050] The dialysis machine 150 can also be connected for remote communication. For example, the dialysis machine 150 can be configured to connect to a network. The connection to the network can be via a wired and / or wireless connection. In one embodiment, the dialysis machine 150 includes, for example, an antenna or other connection component 192 to facilitate connection to the network. The antenna 192 can be, for example, a transceiver for wireless connectivity and / or other signal processors for processing transmitted and received signals. Other medical devices (e.g., other dialysis machines) or components can be configured to connect to the network and communicate with the dialysis machine 150.

[0051] The dialysis machine 150 may also include a speaker 185 and a microphone 187. The controller 155 is operatively connected to the speaker 185 and the microphone 187.

[0052] like Figure 2As shown, sensor 160 may include components for monitoring parameters and be operatively connected to at least controller 155, processor 170, and / or memory 175, or a combination thereof. Processor 170 may be configured to execute an operating system that can provide platform services to application software, such as for operating dialysis machine 150. These platform services may include inter-process and network communication, file system management, and standard database operations. One or more of many operating systems may be used, and the examples are not limited to any particular operating system or operating system feature. In some examples, processor 170 may be configured to execute a real-time operating system (RTOS), such as RTLinux, or a non-real-time operating system, such as BSD or GNU / Linux.

[0053] In one embodiment, processor 170 is arranged and configured to communicate with a user interface (e.g., a touchscreen and control panel). Processor 170 may be configured to receive data from user interface 190 (e.g., touchscreen, control panel), sensors (e.g., weight, air content, flow rate, temperature, and / or pressure sensors), and control dialysis machine 150 based on the received data. For example, processor 170 may adjust operating parameters of dialysis machine 150. According to various examples, processor 170 may be a commercially available processor, such as a processor manufactured by Intel, AMD, Motorola, and Freescale. However, processor 170 may be any type of processor, multiprocessor, or controller, whether commercially available or specially manufactured. For example, according to one example, processor 170 may include an MPC823 microprocessor manufactured by Motorola.

[0054] Memory 175 may include a computer-readable and writable non-volatile data storage medium configured to store non-transitory instructions and data. Furthermore, memory 175 may include processor memory that stores data during operation of processor 170. In some examples, processor memory includes relatively high-performance volatile random access memory, such as dynamic random access memory (DRAM), static RAM (SRAM), or synchronous DRAM. However, processor memory may include any means for storing data, such as non-volatile memory, with sufficient throughput and storage capacity to support the functions described herein. Furthermore, the examples are not limited to specific memories, memory systems, or data storage systems.

[0055] Instructions stored on memory 175 may include executable programs or other code executable by processor 170. Instructions may be persistently stored as coded signals, and instructions may cause processor 170 to perform the functions described herein. Memory 175 may include information recorded on or in a medium, and this information may be processed by processor 170 during instruction execution. Memory 175 may also include data recording specifications such as timing for user timing requirements, treatment and / or operation, historical sensor information, etc. The medium may be, for example, an optical disc, a magnetic disk, or flash memory, and may be permanently attached to or removed from controller 155.

[0056] Sensor 160 may include a pressure sensor for monitoring fluid pressure on machine 150, but sensor 160 may also include a heart rate sensor, a respiration sensor, a temperature sensor, a weight sensor, an air sensor, a video sensor, a thermal imaging sensor, an electroencephalogram (EEG) sensor, a motion sensor, an audio sensor, an accelerometer, a capacitive sensor, or any other suitable sensor. It is understood that sensor 160 may include sensors with varying sampling rates, including wireless sensors.

[0057] Controller 155 may be located within machine 150 or coupled to machine 150 via a communication port or wireless communication link, schematically shown as communication element 158. According to various examples, communication element 158 ​​may support multiple of one or more standards and protocols, such as USB, Wi-Fi, TCP / IP, Ethernet, Bluetooth, Zigbee, CAN-bus, IP, IPv6, UDP, UTN, HTTP, HTTPS, FTP, SNMP, CDMA, NMEA, and / or GSM. As a component located within machine 150, controller 155 may be operatively connected to any of sensors 160, pumps 180, etc. Controller 155 may transmit control signals or trigger voltages to components of machine 150. As discussed, exemplary embodiments of controller 155 may include a wireless communication interface. Controller 155 may detect remote devices to determine if any remote sensors are available to augment any sensor data used for patient assessment.

[0058] Now for reference Figures 3A-3C This illustrates an example of an embodiment of a dialysis machine 200 according to the present disclosure. The dialysis machine 200 may include the components described above in the schematic diagram of system 100, and Figure 1 and Figure 2 The machine 150 is shown. Machine 200 can be configured to provide home dialysis treatment, such as PD. In some embodiments, the dialysis system and machine can be a home PD system, such as a PD system configured for use in a patient's home.

[0059] The dialysis machine 200 may include a housing 242, a door 226, and a cartridge interface including pistons or pump heads 204, 206 (which are interchangeable herein and not intended to be limiting) for contacting a cartridge or cartridge 202 (which are interchangeable and not intended to be limiting), wherein the cartridge 202 is located within a compartment (e.g., cavity 205) formed between the cartridge interface and the closed door 226. Fluid lines (e.g., tubes) may be coupled to the cartridge 202 in a known manner, such as via connectors, and may also include valves for controlling the inflow and outflow of fluid bags and heated pouches, including fresh dialysate. In some embodiments, at least a portion of the fluid lines (e.g., tubes) may be integral with the cartridge 202 when the cartridge 202 is engaged. Before operation, a user can open the door 226 to insert a new cartridge 202 and remove a used cartridge 202 after operation.

[0060] The cartridge 202 can be placed in the cavity 205 of the machine 200 for operation. The machine 200 can manage the flow of dialysis fluid into the patient's abdomen and remove used dialysis fluid and waste after a predetermined time period. During operation, dialysis fluid can flow into the patient's abdomen via the cartridge 202, and used dialysis fluid, waste, and / or excess fluid can be removed from the patient's abdomen via the cartridge 202. In some embodiments, a cartridge pump plate 216 may be provided, which may include a pump mechanism and provide openings for pump heads 204, 206 to operate on the inserted cartridge 202.

[0061] Although dialysate is present in the patient's peritoneal cavity, it can absorb contaminants and / or particulates from the patient's blood. Dialysis (PD) uses the peritoneum of the patient's abdomen as a membrane across which fluids and dissolved substances (such as electrolytes, urea, glucose, albumin, osmotically active particles, and other small molecules) are exchanged from the blood. A patient's PD may involve a total treatment of approximately 10 to 30 liters of fluid, in which approximately 2 liters of dialysate are pumped into the patient's abdomen, held for a period of time, such as about one hour, and then pumped out. This process is repeated until the full treatment volume is reached, and is usually performed overnight while the patient is sleeping.

[0062] Machine 200 can operate pump heads 204 and 206 to move fluid. Pump heads 204 and 206 apply force to cartridge 202, which connects a fluid reservoir, such as a dialysate bag, to a catheter in the patient's peritoneum. Operation of pump heads 204 and 206 allows fresh dialysate to be introduced into the patient's peritoneum. Similarly, pump heads 204 and 206 can draw fluid from the patient's peritoneum into a fluid reservoir or drain it into a waste container. Multiple dialysate bags can be used, including clean and waste fluid reservoirs. Operation of pump heads 204 and 206, along with valves such as valves 208 and 210, controls the delivery or retrieval of fluid.

[0063] In conjunction with the PD machine 200, the heating element 152 may be in the form of a heater tray 240 comprising a heating element 235 positioned, for example, on top of the housing 242 of the machine 200. The heater tray 240 may be of any size and shape to accommodate dialysate bags (e.g., 5L dialysate bags) for batch heating. In use, for example, dialysate bags 234 may be suspended on hooks on the side of a trolley 244, and heater bags 236 may be positioned within the heater tray 240. Connectors and tubing ports may connect the dialysate bags 234 to tubing for transferring the dialysate. Dialysis fluid from the dialysate bags 234 may be transferred in batches to the heater bags 236. For example, a batch of dialysate may be transferred from one or more dialysate bags 234 to the heater bags 236, where the dialysate is heated by the heating element 235. When this batch of dialysate reaches a predetermined temperature (e.g., approximately 98°–100°F, 37°C), the dialysate may be infused into the patient. Dialysis bag 234 and heater bag 236 can be connected to cartridge 202 via dialysate bag tubing or tube 238 and heater bag tubing or tube 238, respectively. Dialysis bag tubing 238 can be used to transfer dialysate from dialysate bag 234 to cartridge 202 during use, and heater bag tubing 246 can be used to transfer dialysate back and forth between cartridge 202 and heater bag 236 during use. Furthermore, patient tubing 248 and discharge tubing 250 can be connected to cartridge 202. Patient tubing 248 can be connected to the patient's abdomen via a catheter and can be used to transfer dialysate back and forth between cartridge 202 and the patient's peritoneal cavity via pump heads 204, 206 during use. Discharge tubing 250 can be connected to a discharge system or discharge container and can be used to transfer dialysate from cartridge 202 to the discharge system or discharge container during use.

[0064] As previously mentioned, fluid may leak from cartridge 202. In particular, fluid may leak at the interface between cartridge 202 and the pump mechanism (e.g., pump head 204, 206) formed in the PD machine 200 (e.g., leakage may occur at the interface between the piston or pump head of the pump mechanism in the dialysis machine and the membrane near the fluid chamber formed in the cartridge).

[0065] According to one or more aspects of this disclosure, dialysis machines, such as PD machines 150, 200, include leak detectors or sensors to detect leaks from, for example, cartridges, and send alarms and / or shut down the dialysis machine and operation. Reference Figure 4According to one aspect of this disclosure, the dialysis machine may include a leak detector, such as one or more sensors 420, positioned within or on surface 410 of pump heads 404, 406 to monitor for leaks. For example, as shown, pump heads 404, 406 include a front surface or contact surface 410. In use, the reciprocating motion of pump heads 404, 406 against cartridge 202 causes movement of the dialysate during the transfer of fluid (e.g., dialysate) from a dialysate source to a patient. Figure 4 As shown in the embodiment, sensor 420 can be arranged and configured in the front surface or contact surface 410 of pump head 404, 406, such that in use, sensor 420 is arranged and configured to detect leakage or fluid on the outer surface of cartridge 202.

[0066] With this arrangement, during normal operation of the dialysis machines 150, 200, fluid (e.g., dialysate) is appropriately contained within its respective fluid bag and / or fluid line. Sensor 420 can be configured to monitor the dialysis machine to ensure patient safety. Upon sensor contact with fluid, etc., on the outer surface of the detection cartridge 202, the dialysis machine 150, 200 can be configured to react to leak detection in any number of ways, including activating an alarm and / or inducing one or more operating conditions. For example, once a leak is detected, a signal can be sent from sensor 420 to, for example, the controller of the dialysis machine to: activate an alarm, stop operation, or a combination thereof. In this way, dialysis treatment can be stopped and the cartridge can be replaced. With this arrangement, leaks can be detected immediately during operation or within a very short time after they occur, and signals can be transmitted to the user and / or patient before the dialysis machine suffers serious damage from a leak.

[0067] In use, sensor 420 can be any suitable sensor now known or developed in the future, arranged and configured to detect fluid on the outer surface of the housing. For example, in one embodiment, sensor 420 can be a capacitive sensor. However, alternatively, other suitable sensors for detecting leaks can be used; for example, sensor 420 can be a circuit that, in the event of a leak, causes a short circuit, thereby triggering a leak alarm and / or causing other alarm events.

[0068] refer to Figure 4In the illustrated embodiment, sensor 420 is integrated into the pump heads 404, 406 of the dialysis machines 150, 200. For example, sensor 420 may be a capacitive sensor positioned in the piston of the pump assembly or in the front or contact surface 410 of the pump head 404, 406. This arrangement places the capacitive sensor 420 on the contact surface 410 of the pump head 404, 406 and moves it to contact the outer surface of the cartridge 202. In use, the capacitive sensor 420 is arranged and configured to detect, monitor, and measure fluid, etc., on the outer surface of the cartridge, the front or contact surface 410 of the pump head 404, 406, and / or on the sensor 420.

[0069] Sensor 420 may also include one or more wires, cables, etc., for transmitting signals from sensor 420 to, for example, a controller or processor of a dialysis machine, which interprets the signals to determine leaks in the cartridge. For example, in use, capacitive sensor 420 may provide a signal that changes when capacitive sensor 420 detects fluid on the surface 410 of pump heads 404, 406 that is in normal contact with the dry film of the cartridge, etc. This arrangement allows for continuous leak monitoring of the dialysis machine.

[0070] Sensor 420 can have any suitable shape, such as circular, square, etc., and can be positioned at any location on the surface 410 of pump heads 404, 406 for detecting the presence of fluid on either surface 410 of pump heads 404, 406 and / or the outer surface of housing 202. Sensor 420 can be coupled to pump heads 404, 406 by any suitable mechanism (e.g., fasteners, adhesives, etc.).

[0071] Alternatively and / or additionally, in another embodiment, the sensor may be located on or near the inlet fluid line of the cartridge to detect leaks when fluid (e.g., dialysate) enters the cartridge and / or dialysis machine.

[0072] Once a leak is detected, dialysis machines 150, 200 can be arranged and configured to take one or more actions. For example, dialysis machines 150, 200 can be arranged and configured to generate alarm conditions, such as visual and / or auditory notifications. For example, a signal can be sent to a user interface portion of the dialysis machine to indicate a leak, and / or an audio or light indicator can be triggered. In some embodiments, dialysis machines 150, 200 can transmit alarm conditions (e.g., via a wireless connection) to remote locations, including but not limited to doctor's offices, hospitals, call centers, and technical support. For example, dialysis machines 150, 200 can provide real-time remote monitoring of machine operation. Dialysis machines 150, 200 may include memory for storing data, or can transmit data to a local or remote server at predetermined time intervals.

[0073] Additionally and / or alternatively, dialysis machines 150, 200 may be arranged and configured to automatically shut down, or allow users to monitor, pause, and / or stop dialysis operations based on leak detection.

[0074] refer to Figure 5 A flowchart 500 illustrating a method for detecting leaks during dialysis operation according to an embodiment of the present invention is shown. In step 505, components of the dialysis machines 150, 200 are inserted; for example, cartridge 202 may be inserted into a cavity of the dialysis machine housing. In step 510, the dialysis machine is operated by pumping dialysis fluid via the cartridge. As described above, in peritoneal dialysis operation, fresh dialysis fluid can be pumped into the patient's abdomen, while used dialysis fluid, including waste and excess fluid, can drain out of the patient's abdomen. In step 515, the dialysis machine's leakage status is monitored by a leak detector (e.g., a sensor). The leak detector may be a capacitive sensor positioned on the front surface of a pump head used to move dialysis fluid from a fluid source to the patient. In step 520, when a leak is detected in the dialysis machine, a signal is transmitted from the sensor to the machine's processor. As described above, the machine may send an audible or visual indication of the leakage status and, alternatively or additionally, automatically stop the dialysis operation.

[0075] The system described herein has been explained in conjunction with a dialysis machine having a specific configuration. It is anticipated that the system described herein can be used with dialysis machines having other configurations, such as different types of dialysis machines and / or dialysis machines with cartridges that can be positioned in other configurations and have other features. The system described herein can be used with any suitable dialysis machine and / or other medical devices using disposable cartridges that can benefit from leak detection.

[0076] Some embodiments of the disclosed systems may be implemented, for example, using a storage medium, a computer-readable medium, or an article of manufacture capable of storing instructions or instruction sets, which, if executed by a machine (i.e., a processor or microcontroller), could cause the machine to perform methods and / or operations according to embodiments of this disclosure. Furthermore, a server or database server may include a machine-readable medium configured to store machine-executable program instructions. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, etc., and may be implemented and used in a system, subsystem, component, or subcomponent thereof using any suitable combination of hardware, software, firmware, or a combination thereof. Computer-readable media or articles may include, for example, any suitable type of memory unit, memory device, memory article, memory medium, storage device, storage article, storage medium and / or storage unit, such as memory (including non-temporary memory), removable or non-removable media, erasable or non-erasable media, writable or rewritable media, digital or analog media, hard disk, floppy disk, optical disc read-only memory (CD-ROM), optical disc recordable (CD-R), rewritable optical disc (CD-RW), optical disc, magnetic media, magneto-optical media, removable memory cards or disks, various types of digital versatile optical discs (DVDs), magnetic tape, cassette tape, etc. Instructions may include any suitable type of code implemented using any suitable high-level, low-level, object-oriented, visual, compiled and / or interpreted programming language, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, etc.

[0077] As used herein, elements or operations described in the singular and beginning with the words “a” or “an” should be understood to not exclude plural elements or operations unless such exclusion is explicitly stated. Furthermore, references to “one embodiment” in this disclosure are not intended to exclude the existence of additional embodiments that also include the described features.

[0078] Although the systems and techniques for leak detection described herein have been explained with considerable reference to dialysis machines, particularly peritoneal dialysis machines, the described systems and techniques for leak detection can be used in conjunction with other types of medical systems and / or machines, such as hemodialysis machines or other medical devices involving medical fluids. In some embodiments, the dialysis machine can be configured for use in a patient's home (e.g., a home dialysis machine). Home dialysis machines can take the form of peritoneal dialysis machines or home hemodialysis machines.

[0079] The scope of this disclosure is not limited to the specific embodiments described herein. In fact, various other embodiments and modifications of this disclosure, besides those described herein, will be apparent to those skilled in the art from the foregoing description and drawings. Therefore, such other embodiments and modifications are intended to fall within the scope of this disclosure. Furthermore, although this disclosure has been described for a particular purpose, in a particular environment, and in the context of a particular implementation, those skilled in the art will recognize that its use is not limited thereto, and that this disclosure can advantageously achieve any number of purposes in any number of environments. Therefore, the claims set forth below should be interpreted in accordance with the full scope and spirit of this disclosure as set forth herein.

Claims

1. A dialysis system for performing dialysis treatment, comprising: A dialysis machine for transferring dialysis fluid from a dialysis fluid source to a patient, the dialysis machine comprising a housing having a cavity, a pump having a pump head positioned within the housing, and sensors associated with the pump; as well as A box that can be positioned within the cavity, the box being in fluid communication with the patient and the dialysis fluid source; When the cartridge is positioned within the cavity, the movement of the pump causes the front contact surface of the pump head to contact the cartridge, thereby transferring dialysate from the dialysate source to the patient. The sensor is positioned on the front contact surface of the pump head to detect the presence of fluid on one of the outer surfaces of the cartridge or one of the front contact surfaces of the pump head.

2. The dialysis system according to claim 1, wherein, The sensor is a capacitive sensor arranged and configured to detect the presence of fluid.

3. The dialysis system according to claim 2, wherein, The capacitive sensor is located inside the pump.

4. The dialysis system according to any one of claims 1-3, wherein, The sensor is configured to send a signal to indicate a leak based on the detection of fluid by the sensor; The signal is sent to the dialysis machine's user interface, sound indicator, light indicator, or a combination thereof.

5. The dialysis system according to claim 4, wherein, The dialysis machine is arranged and configured to automatically terminate the transfer of dialysis fluid from the dialysis fluid source to the patient upon receiving a signal.

6. A dialysis system for performing dialysis treatment, comprising: A dialysis machine arranged and configured to transfer dialysate from a dialysate source to a patient, the dialysis machine including a housing having a cavity and a pump positioned within the housing for facilitating dialysate transfer, the pump having a pump head; as well as A capacitive sensor is located within the pump head, the pump head including a front contact surface configured to contact a cartridge located within a cavity of the housing, the cartridge being in fluid communication with a patient and a dialysate source, the capacitive sensor being disposed within the front contact surface of the pump head, or on the front contact surface of the pump head, or a combination thereof, wherein leakage is detectable in response to fluid contact with the capacitive sensor.

7. The dialysis system according to claim 6, wherein, During operation of the dialysis machine, the pump contacts the cartridge, and the capacitive sensor is arranged and configured to detect the presence of fluid.

8. The dialysis system according to claim 7, wherein, The capacitive sensor is arranged and configured to detect the presence of fluid on one of the outer surfaces of the housing and the front contact surface of the pump head.

9. The dialysis system according to any one of claims 7-8, wherein, In response to a leak, the dialysis machine is arranged and configured to send a signal to indicate the leak condition, the signal being sent to the dialysis machine's user interface, an audible indicator, a visual indicator, or a combination thereof.

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