Wearable peritoneal dialysis system

Abstract

A wearable peritoneal dialysis system includes: a PD fluid supply assembly including an outer container and an inner PD fluid supply container sealed within the outer container; a pumping unit including an air pump having a positive pressure outlet and a negative pressure outlet; a PD fluid discharge assembly including an outer leg container configured to be worn around a leg of a patient and an inner PD fluid discharge container sealed within the outer leg container; and a control unit configured to: (i) cause positive pneumatic pressure to be supplied from the positive pressure outlet to the outer container to force fresh PD fluid to flow from the inner PD fluid supply container to the patient; and (ii) supplying a negative pneumatic pressure from the negative pressure outlet to the inner container to force the used PD fluid to flow from the patient towards the inner PD fluid discharge container.

Description

Background Art

[0001] For various reasons, a person's renal system can fail. Renal failure produces several physiological disturbances. For example, a person with renal failure can no longer balance water and minerals or excrete the daily metabolic load. In addition, toxic end products of metabolism (such as urea, creatinine, uric acid, etc.) may accumulate in the patient's blood and tissues.

[0002] Decreased kidney function, particularly renal failure, is treated with dialysis. Dialysis removes waste products, toxins and excess water from the body that would otherwise be removed by normally functioning kidneys. Dialysis treatment to replace kidney function is vital for many people, as this treatment is life-saving.

[0003] One type of renal failure treatment is hemodialysis ("HD"), which typically uses diffusion to remove waste products from a patient's blood. In a semipermeable dialyzer, a diffusion gradient occurs between the blood and an electrolyte solution (called the dialysate or dialysis fluid), causing diffusion. Diffusion occurs outside the patient's body, where an extracorporeal circuit is used to remove unpurified blood and return purified blood to the patient.

[0004] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from the patient's blood. HF is achieved by adding a replacement fluid, or substitution fluid, to an extracorporeal circuit during treatment. During HF treatment, the replacement fluid and the patient's accumulated fluid between treatments are ultrafiltered, thereby providing a convective transport mechanism that is particularly advantageous for the removal of medium and large toxic molecules.

[0005] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearance. Similar to standard hemodialysis, HDF uses a dialysis fluid that flows through a dialyzer to provide diffusive clearance. In addition, a replacement solution is provided directly to the extracorporeal circuit to provide convective clearance.

[0006] Another type of renal failure treatment is peritoneal dialysis ("PD"), which injects a dialysis solution (also called dialysis fluid) into the patient's peritoneal cavity via a catheter. The dialysis fluid contacts the peritoneum in the patient's peritoneal cavity. Waste products, toxins, and accumulated water (ultrafiltration) flow from the patient's blood through the capillaries in the peritoneum and enter the dialysis fluid due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. The osmotic agent in the PD dialysis fluid provides the osmotic gradient. Used or exhausted dialysis fluid is drained from the patient, thereby removing waste products, toxins, and excess water from the patient. This cycle is repeated, for example, multiple times.

[0007] There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain tube to allow used or exhausted dialysis fluid to drain from the peritoneal cavity. The patient then switches the fluid connection so that the patient's catheter is connected to a bag of fresh dialysis fluid to inject fresh dialysis fluid into the patient through the catheter. The patient disconnects the catheter from the bag of fresh dialysis fluid and allows the dialysis fluid to reside in the peritoneal cavity, where transfer of waste, toxins, and excess water occurs. After the dwell period, the patient repeats the manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving much room for improvement.

[0008] Automated peritoneal dialysis ("APD") is similar to CAPD in that dialysis treatment includes drain, fill, and dwell cycles. However, the APD machine performs the cycles automatically, usually while the patient is sleeping. The APD machine relieves the patient from having to manually perform treatment cycles and from having to transport supplies during the day. The APD machine is fluidly connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. The APD machine pumps fresh dialysis fluid from a dialysis fluid source through a catheter and into the patient's peritoneal cavity. The APD machine also allows the dialysis fluid to remain in the cavity and allows for the transfer of waste, toxins, and excess water. The source can include multiple liters of dialysis fluid (including several solution bags).

[0009] The APD machine pumps used or exhausted dialysate from the patient's peritoneal cavity through a catheter and to a drain. As with the manual process, several drain, fill, and dwell cycles occur during dialysis. The "last fill" may occur at the end of an APD treatment. The fluid from the last fill may remain in the patient's peritoneal cavity until the next treatment begins, or it may be manually emptied at some point during the day.

[0010] In any of the above ways of using an automated machine, the automated machine is stationary, for example, in the patient's home. The form factor of the APD machine requires that the patient be secured to a bed or chair during renal failure treatment, which may last up to eight hours. Therefore, patients undergoing APD treatment are typically strapped to the machine, which is why APD treatment is typically performed at night. However, some patients prefer to perform PD treatment while awake so that they can attempt to avoid alarms that are caused in many cases due to the patient's sleeping position and be able to handle the alarms without being awakened. The patient can then enjoy their sleep without having to integrate PD treatment. In addition, some patients who perform PD treatment at night while sleeping still have to perform midday PD fluid exchanges, which may require the patient to have to return home, where supplies for performing midday exchanges are stored at home.

[0011] Therefore, there is a need for a portable or mobile machine for peritoneal dialysis while the patient is moving or in a situation requiring mobility. Summary of the invention

[0012] Disclosed herein are example systems, methods, and devices for a wearable peritoneal dialysis ("PD") system that performs PD therapy while a patient is moving or in a situation that requires the patient to move. An example PD system in one embodiment includes three main components, namely a PD fluid supply assembly, a pumping unit, and a PD fluid discharge assembly. The PD fluid supply assembly includes an outer supply container and an inner PD fluid supply container. The outer supply container can be rigid (such as a rigid plastic), or can be a flexible container such as a flexible airtight fabric (e.g., canvas) that does not stretch significantly when placed under positive pneumatic pressure. In one embodiment, the outer supply container can be opened, for example, hinged open, so as to be able to receive a new inner PD fluid supply container, which can be a standard pre-sterilized PD fluid bag. The outer supply container includes a sealing interface so that when the outer supply container is closed around the inner PD fluid supply container, the outer supply container is sealed around the inner PD fluid supply container in an airtight manner. The outer supply container may include one or more latches that are releasably closed to compress the sealing interface during operation of the wearable PD system of the present disclosure. If the outer supply container is flexible (e.g., canvas), the sealing interface can include an airtight zipper. Regardless of the material of the outer supply container, the sealing interface in one embodiment also seals around a supply connector (e.g., a standard PD fluid bag connector) that extends from the inner PD fluid supply container. In this way, the supply connector can be connected to a PD fluid supply line outside the outer supply container. In a similar manner, the outer supply container includes a pneumatic connector that can be accessed and connected to a positive pneumatic line outside the outer supply container.

[0013] The outer supply container is reusable and in one embodiment includes one or more sensors located at the bottom of the container for sensing when the PD fluid located in the inner PD fluid supply container is almost completely gone (delivered to the patient). The sensor can be any type of sensor that is capable of detecting the presence of PD fluid or air through the wall of the inner PD fluid supply container. Such a sensor can be, for example, an ultrasonic sensor, a magnetic sensor, a capacitive sensor, or an inductive sensor. The outer supply container and the inner PD fluid supply container are sized here so that the inner PD fluid supply container is tightly held within the outer supply container so that the sensor is always pressed against the wall of the inner fluid supply container to provide an accurate output signal.

[0014] The PD fluid supply assembly in one embodiment also includes a backpack that is worn by the patient and into which the outer supply container and the nested inner PD fluid supply container are placed while the patient moves from one location to another for whatever reason and while the patient is receiving treatment. The backpack and the enclosed outer and inner PD fluid supply containers can be removed from the patient and placed next to the patient (for example, during treatment, when the patient has arrived at a destination and the patient needs to remain stationary at the destination for a period of time). The backpack can also include structure for hanging the outer and inner containers, such as one or more hooks, the outer and inner containers, for example, having one or more holes for receiving the one or more hooks, so that the bottom of the outer supply container rises from the bottom of the backpack during operation. In an alternative embodiment, the outer supply container and the nested inner container are supported by the bottom of the backpack during operation.

[0015] The PD fluid supply assembly may also include: one or more clips, such as a PD fluid supply clip, for clamping the PD fluid supply line; and a pneumatic line clip for clamping the positive pneumatic line leading to the external supply container. The PD fluid supply clip and the pneumatic line clip may be secured, for example, to an inner surface of a backpack, wherein a patient, when positioning the wearable PD system for use, places the PD fluid supply line and the positive pneumatic line into the PD fluid supply clip and the pneumatic line clip, respectively, wherein the lines are kept secured to the clips during treatment and until the patient removes the lines after treatment.

[0016] The PD fluid supply assembly may further include a heater or warmer, such as a heating blanket or warming blanket, located within the backpack. In one embodiment, the heater or warmer is configured to heat itself to patient temperature, such as 37°C, which brings the PD fluid to or close to patient temperature in an efficient manner within the closed environment of the backpack without the possibility of overheating. Similar to the fluid level sensor, the outer supply container may be provided with one or more temperature sensors to contact the inner PD fluid supply container to obtain the temperature of the PD fluid contained therein. A simple on / off temperature control may be used, with the heater or warmer powered on until the one or more temperature sensors read 37°C, after which the heater or warmer is powered off until the one or more temperature sensors read an acceptable lower temperature, such as 32°C, after which the above cycle is repeated.

[0017] The pumping unit of the wearable PD system of the present disclosure in one embodiment includes an air pump or pneumatic pump having a positive pressure outlet and a negative pressure outlet. The pumping unit also includes a control unit that controls: whether the air pump is pumping; whether each clamp is open or closed; and whether the heater or warmer (if provided) is powered. The control unit also receives outputs from any sensors associated with the wearable PD system. The pumping unit can be located in a backpack or worn elsewhere by the patient, such as on the patient's belt.

[0018] The control unit of the pumping unit provides a user interface, or operates with a user interface. For example, if the pumping unit is worn on the patient's belt, the user interface can be located on the control unit. Here, the user interface may include a touch screen display and / or one or more buttons (such as a membrane switch) to allow the patient to enter data and commands into the user interface. If the pumping unit is instead located in a backpack, the user interface can be provided as a mobile application that is downloaded to the user's smartphone or tablet (smart device) and played via the smartphone or tablet. Here, the control unit includes a transceiver for wireless two-way communication with the user's smartphone or tablet. When the mobile application is installed, the application is paired or registered with the control unit of the wearable PD system of the present invention, after which the smartphone and the control unit will only communicate with each other. In addition, after pairing or registration, the mobile application and the control unit will automatically synchronize when both the smartphone and the control unit are powered on.

[0019] The user interface allows the patient to start treatment using the wearable PD system of the present disclosure after placement. The user interface allows the patient to pause or stop treatment at any time. When starting treatment, the user interface can display a message to the patient to confirm that each of the PD fluid supply assembly, pumping unit, and PD fluid discharge assembly has been placed and connected together. After receiving confirmation from the patient, the control unit starts treatment and causes automatic operation of each of the air pump or pneumatic pump, clamp, and PD fluid heater or warmer (if provided).

[0020] Regarding pneumatic line connectivity, a positive pneumatic line leading to an external supply container is connected to a positive pressure outlet of an air pump or pneumatic pump. A second negative pneumatic line is provided and connected to a negative pressure outlet of an air pump or pneumatic pump. The negative pneumatic line leads to one or more outer leg containers of the PD fluid discharge assembly. Each one or more outer leg containers operate together with a nested inner PD fluid discharge container. In one embodiment, the outer leg container and the inner PD fluid discharge container are cylindrical so that they can slide up onto one or both feet of the patient and rest around one or both legs of the patient. The outer leg container may also be rigid (e.g., rigid plastic), or may be flexible, such as an airtight fabric, such as canvas. If rigid, the outer leg container includes an openable and sealable top that allows the inner PD fluid discharge container to be placed within the outer leg container. The rigid top and rigid cylindrical body of the outer leg container may be sealed together via the closure of inner and outer O-rings and one or more releasable latches to hold the rigid top and the rigid cylindrical body together in a sealed manner. If flexible, the lid may include an airtight outer zipper and an inner O-ring seal for sealing the lid to the inner cylindrical wall of the flexible cylindrical body of the outer leg container.

[0021] In one embodiment, the inner PD fluid drain container is a flexible plastic container. The inner PD fluid drain container is cylindrical in shape and in one embodiment includes a drain line that is welded or otherwise permanently connected to the container so that the drain line cannot be accidentally pulled out of the container while the patient is walking or otherwise moving. The cover of the outer leg container is provided with a stretchable spandex-like sealing sleeve that allows the connector on the connection end of the drain line to slide over the sealing sleeve, which then seals to the drain line.

[0022] The PD fluid discharge assembly also includes a discharge clamp for each discharge line. In one embodiment, the discharge clamp is located at the cover and clamps onto the corresponding discharge line just above the sealing sleeve. The patient inserts the discharge line into the discharge clamp, which releasably holds the discharge line during treatment. The cover of each outer leg container is also provided with a pneumatic connector, which is used to connect to a negative pneumatic line extending from an air pump or a pneumatic pump. The cover of each outer leg container is also provided with a pneumatic clamp for clamping the negative pneumatic line.

[0023] In one embodiment, the PD fluid supply assembly, pumping unit, and PD fluid discharge assembly are each powered by a battery. In one embodiment, the battery power source is a rechargeable battery power source. A separate battery can be provided for each of the PD fluid supply assembly, pumping unit, and PD fluid discharge assembly. Here, no wires extending to the fluid and pneumatic clamps are required, and the clamps can be actuated wirelessly, for example, over the same WIFI network that allows the user interface on the user's smartphone to interact with the control unit. The patient can plug a recharge cord into each of the three separate batteries at the end of the day.

[0024] In an alternative embodiment, a single battery is provided by the pumping unit. Embedded and insulated electrical wires are positioned along the interior surface of the backpack and extend to the fresh PD fluid line clamp, the pneumatic line clamp, and the heater or warmer (if provided). If the pumping unit is located within the backpack, the patient does not need to make an electrical connection between the pumping unit and the PD fluid supply assembly. If the pumping unit is instead positioned along the patient's waist belt, the patient makes an electrical connection between the pumping unit and the PD fluid supply assembly. It is also contemplated that the negative pneumatic line is positioned within an insulating sleeve and that the electrical wires are also extended through the insulating sleeve to the lid of each outer leg container. The electrical wires exit the sleeve at the lid and connect to each of the spent PD fluid line clamps and the pneumatic line clamps.

[0025] The disposable kit of the wearable PD system of the present disclosure includes: a nested inner PD fluid supply container (e.g., a standard PD fluid container); a PD fluid supply line; one or more PD fluid drain lines; one or more PD fluid drain containers; and a line connection manifold. The line connection manifold includes: a transfer kit connector for connecting to a patient's PD fluid transfer kit; and at least one drain connector for connecting to the one or more PD fluid drain lines. In one embodiment, the PD fluid supply line extends from the line connection manifold, extends through an opening in the backpack, and extends to a supply connector located at the nested inner PD fluid supply container. The PD fluid supply line in an alternative embodiment is welded or otherwise permanently affixed to the nested inner PD fluid supply container and is alternatively connected to a supply connector located at the line connection manifold. In any case, the patient makes two and possibly three fluid connections, once for the supply connector, and once or twice for the one or two drain connectors.

[0026] The patient also makes one or two pneumatic connections, once for each negative pneumatic line and pneumatic connector located on one or more outer leg containers. After treatment, the patient removes each drain line from the line connection manifold and removes the negative pneumatic line from each outer leg container, so that each outer leg container can be removed from the patient. It is envisioned that the positive pneumatic lines remain connected between the pumping unit and the outer supply containers of the PD fluid supply assembly (particularly if the pumping unit is located in a backpack). If the pumping unit is instead located at the patient's waist belt, it is envisioned that the patient is allowed to disconnect both the PD fluid supply lines (which can be manually clamped before removal) and the positive pneumatic lines, so that the backpack is then unfastened from the patient and can be removed and left behind after the patient is finished filling.

[0027] If a heater or warmer is provided, the control unit may power the heater or warmer along with the external supply container and the PD fluid supply container located within the backpack before making a therapy connection. If the heater draws too much power from the battery, the backpack may provide a separate AC plug to power the heater or warmer. It is also contemplated that instead of providing a heater, the patient may be instructed to store the PD fluid supply container in a warm location.

[0028] After the fresh PD fluid is heated, the above connections are made, and the patient begins treatment using the user interface, the control unit causes: (i) the PD fluid supply clamp to open; (ii) the positive pressure pneumatic clamp to open; and (iii) the air pump to energize and pump positive pressure air to the outer supply container of the PD fluid supply assembly. The positive air pressure can be, for example, 1.5 psig to 3.0 psig. The control unit also briefly causes one of the drain clamps to open and causes the user interface to prompt the patient to look for fresh PD fluid in the line connection manifold (indicating that the PD fluid supply line has been primed). When the patient confirms at the user interface that the PD fluid supply line has been primed, the user interface next prompts the patient to open the manual valve of the patient transfer kit. The positive pressure air pressurizes the space between the outer supply container and the nested inner PD fluid supply container, forcing fresh PD fluid to flow out of the inner PD fluid supply container, through the PD fluid supply line, through the line connection manifold, through the patient's transfer kit, and through the patient's indwelling catheter into the patient's peritoneal cavity. In one embodiment, the control unit receives a signal from a level sensor indicating that the PD fluid supply container is empty or nearly empty. The control unit may: stop the air pump; or make the air pump wait for a period of time, such as one or more minutes, before stopping the air pump.

[0029] In an alternative embodiment, a level sensor is not provided, and instead the control unit energizes the air pump for a period of time sufficient to anticipate that all or substantially all of the fresh PD fluid has been delivered from the inner PD fluid supply container to the patient's peritoneal cavity. It is contemplated that at any time during the patient's fill (perhaps near the end) the patient is allowed to press a stop button at the user interface when the patient feels sufficiently full. When the patient's fill has been completed, the control unit removes power from the PD fluid supply clamp and the positive pressure pneumatic clamp, which in one embodiment are closed in a safe manner. The control unit also removes power from the heater (if provided, and if still energized at the end of the patient's fill).

[0030] After the air pump is stopped, the control unit begins a timed patient stay. The timed patient stay may last from one to two hours. At any time while the patient is sitting or otherwise not moving, even during patient filling, the patient may remove the backpack and place it beside the patient, e.g., at or above the patient's peritoneal cavity, so that gravity assists in patient filling. As discussed above, it may be feasible to unhook the patient from the backpack after patient filling and during the patient stay.

[0031] When the timed patient stay as determined by the control unit ends, the control unit causes: (i) the one or more drain clamps to open; (ii) the negative pressure pneumatic clamps to open; and (iii) the air pump to energize and pull negative pressure at the one or more outer leg containers. The negative pressure is applied to the one or more PD fluid drain containers and is transmitted to the spent PD fluid residing in the patient through the one or more drain lines, the line connection manifold, the patient's transfer kit, and the patient's indwelling catheter. The negative pneumatic pressure thus helps to begin to cause the spent PD fluid to flow from the patient's peritoneal cavity to the one or more PD fluid drain containers. In one embodiment, the control unit energizes the air pump for a period of time sufficient to anticipate that all or substantially all of the spent PD fluid has been drained from the patient's peritoneal cavity to the one or more PD fluid drain containers. Depending on the size of the PD fluid supply container (e.g., two liters), it may be desirable to provide two PD fluid drain containers, for example, each PD fluid drain container holding one liter of spent PD fluid plus the expected patient ultrafiltration volume, so that the spent PD fluid in each leg is lightened and evenly distributed.

[0032] In view of the disclosure set forth herein and without limiting the disclosure in any way, in a first aspect of the present disclosure (which may be combined with any other aspect or portion thereof), a wearable peritoneal dialysis ("PD") system comprises: a PD fluid supply assembly, the PD fluid supply assembly comprising an outer supply container and an inner PD fluid supply container sealed within the outer supply container; a pumping unit, the pumping unit comprising an air pump, the air pump having a positive pressure outlet and a negative pressure outlet; a PD fluid discharge assembly, the PD fluid discharge assembly comprising at least one outer leg container and at least one inner PD fluid discharge container sealed within the at least one outer leg container, the at least one outer leg container being configured to be worn around a patient's leg; and a control unit, the control unit being configured to: (i) supply positive pneumatic pressure from the positive pressure outlet to the outer supply container to force fresh PD fluid to flow from the inner PD fluid supply container to the patient; and (ii) supply negative pneumatic pressure from the negative pressure outlet to the at least one inner container to force used PD fluid to flow from the patient toward the inner PD fluid discharge container.

[0033] In a second aspect of the present disclosure (which may be combined with any other aspect or part thereof), the control unit is configured to: (i) supply positive pneumatic pressure during patient filling; and (ii) supply negative pneumatic pressure during patient draining.

[0034] In a third aspect of the present disclosure (which may be combined with any other aspect or part thereof), the control unit is located within the pumping unit.

[0035] In a fourth aspect of the present disclosure (which may be combined with any other aspect or part thereof), the outer supply container is configured to open and close around the inner PD fluid supply container, and wherein the outer supply container includes a sealing interface for sealing the PD fluid supply container within the outer supply container.

[0036] In a fifth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), a supply connector extends from the inner PD fluid supply container through the outer supply container in a sealed manner, and wherein a PD fluid supply line extends from the supply connector toward a PD fluid transfer kit carried by the patient.

[0037] In a sixth aspect of the present disclosure (which may be combined with any other aspect or part thereof), the wearable PD system comprises a PD fluid supply clamp under the control of the control unit, and wherein the PD fluid supply line extends through the PD fluid supply clamp.

[0038] In a seventh aspect of the present disclosure (which may be combined with any other aspect or part thereof), the wearable PD system comprises a line connection manifold in fluid communication with the PD fluid transfer kit, and wherein the PD fluid supply line extends to the line connection manifold.

[0039] In an eighth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the at least one drain line extends in a sealed manner from the at least one inner PD fluid drain container through the at least one outer leg container and toward a PD fluid transfer kit carried by the patient.

[0040] In a ninth aspect of the present disclosure (which may be combined with any other aspect or part thereof), the wearable PD system comprises at least one drain clamp under the control of the control unit, and wherein the at least one drain line extends through the at least one drain clamp.

[0041] In a tenth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the wearable PD system comprises a line connection manifold in fluid communication with the PD fluid transfer kit, and wherein the at least one exhaust line extends to the line connection manifold.

[0042] In an eleventh aspect of the present disclosure, which may be combined with any other aspect or portion thereof, the at least one drain line extends from the at least one inner PD fluid drain container through a stretchable sealing sleeve of the at least one outer leg container in a sealed manner.

[0043] In a twelfth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the wearable PD system includes a positive pneumatic line extending from the positive pressure outlet to the external supply container.

[0044] In a thirteenth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the wearable PD system comprises a pneumatic line clamp under the control of the control unit, and wherein the positive pneumatic line extends through the pneumatic line clamp.

[0045] In a fourteenth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the wearable PD system comprises at least one negative pneumatic line extending from the negative pressure outlet to the at least one outer leg container.

[0046] In a fifteenth aspect of the present disclosure (which may be combined with any other aspect or part thereof), the wearable PD system comprises at least one pneumatic line clamp under the control of the control unit, and wherein the at least one negative pneumatic line extends through the at least one pneumatic line clamp.

[0047] In a sixteenth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the at least one negative pneumatic line extends to a sealable lid of the at least one outer leg container.

[0048] In a seventeenth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the at least one negative pneumatic line together with electrical wires extends through at least one insulating sleeve to the at least one outer leg container.

[0049] In an eighteenth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the outer supply container, the inner PD fluid supply container, and optionally (i) the pumping unit and (ii) the control unit are located in a backpack that can be worn by the patient.

[0050] In a nineteenth aspect of the present disclosure (which may be combined with any other aspect or portion thereof), the wearable PD system includes a heater or warmer disposed within the backpack, the heater or warmer being positioned and arranged to heat fresh PD fluid located within the internal PD fluid supply container.

[0051] In the twentieth aspect of the present disclosure (which may be combined with any other aspect or part thereof), the wearable PD system according to claim 1 includes a mobile application provided on a smart device that communicates data with the control unit, and the mobile application provides a user interface for the wearable PD system.

[0052] In a twenty-first aspect of the present disclosure (which may be combined with any other aspect or portion thereof), a wearable peritoneal dialysis ("PD") system comprises: a PD fluid supply assembly, the PD fluid supply assembly comprising an outer supply container and an inner PD fluid supply container sealed within the outer supply container; an air pump; a control unit, the control unit being configured such that positive pneumatic pressure is supplied from the air pump to the outer supply container to force fresh PD fluid to flow from the inner PD fluid supply container to a patient; and a backpack, wherein the outer supply container, the inner PD fluid supply container, and optionally the air pump and the control unit are located within the backpack.

[0053] In the twenty-second aspect of the present disclosure (which may be combined with any other aspect or part thereof), the wearable PD system includes at least one outer leg container and at least one inner PD fluid discharge container, wherein the at least one outer leg container is configured to be worn around the patient's leg, and the at least one inner PD fluid discharge container is sealed within the at least one outer leg container, wherein the air pump includes a positive pressure outlet and a negative pressure outlet, and wherein the control unit is configured to: (i) supply the positive pneumatic pressure from the positive pressure outlet to the outer supply container to force fresh PD fluid to flow from the inner PD fluid supply container to the patient; and (ii) supply negative pneumatic pressure from the negative pressure outlet to the at least one inner container to force used PD fluid to flow from the patient toward the at least one inner PD fluid discharge container.

[0054] In a twenty-third aspect of the present disclosure (which may be combined with any other aspect or part thereof), Figure 1 and Figure 2 Any features, functions, and alternatives described in relation to any one or more of the figures in the Figure 1 and Figure 2 Any feature, function and alternative combination described in relation to any other figure in the.

[0055] In view of the present disclosure and the above aspects, therefore, an advantage of the present disclosure is to provide a relatively simple and inexpensive wearable PD system.

[0056] Another advantage of the present disclosure is to provide PD therapy that can be performed while the patient is moving.

[0057] Yet another advantage of the present disclosure is to provide a wearable PD system that is at least partially removable when the patient is not moving.

[0058] Yet another advantage of the present disclosure is to provide a wearable PD system that is at least partially removable after the patient filling phase has been completed.

[0059] Additional features and advantages are described in and will be apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art upon viewing the accompanying drawings and description. Furthermore, it is not necessary for any particular embodiment to have all of the advantages listed herein, and it is expressly contemplated that each advantageous embodiment is separately claimed. Furthermore, it should be noted that the language used in the specification has been selected primarily for readability and instructional purposes, and not for limiting the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 is a diagram of one embodiment of a wearable peritoneal dialysis system of the present disclosure.

[0061] Figure 2 is a side elevation view of a patient wearing a wearable peritoneal dialysis system of the present disclosure. DETAILED DESCRIPTION

[0062] Disclosed herein are example systems, methods, and apparatus for a wearable peritoneal dialysis ("PD") system 10 that performs PD therapy while a patient is moving or in situations where the patient must move. Figure 1 and Figure 2, an example PD system 10 in one embodiment includes three main components, namely a PD fluid supply assembly 20, a pumping unit 70, and a PD fluid discharge assembly 100. The PD fluid supply assembly 20 includes an outer supply container 22 and an inner PD fluid supply container 40. The outer supply container 22 can be rigid (such as a rigid plastic), or can be a flexible container such as a flexible airtight fabric (e.g., canvas) that does not stretch significantly when placed under positive pneumatic pressure. The outer supply container 22 in one embodiment includes first and second halves 24a, 24b that can be opened, for example, via one or more hinges 26a, 26b, so as to be able to receive a new inner PD fluid supply container, which can be a standard pre-sterilized PD fluid bag. The outer supply container 22 includes a sealing interface 28 (e.g., via a compressible gasket) so that when the outer supply container 22 is closed around the inner PD fluid supply container, the outer supply container is sealed around the inner PD fluid supply container in an airtight manner. The outer supply container 22 may include one or more latches 30a, 30b, which are releasably closed to compress the sealing interface 28 during operation of the wearable PD system 10 of the present disclosure. If the outer supply container 22 is flexible (e.g., canvas), the sealing interface 28 may include an airtight zipper. Regardless of the material of the outer supply container 22, the sealing interface 28 in one embodiment also includes a portion 28p that seals around a supply connector 42 (e.g., a standard PD fluid bag connector) that extends from the inner PD fluid supply container. In this way, the supply connector 42 can be connected to a PD fluid supply line 44 outside the outer supply container 22. In a similar manner, the outer supply container 22 includes a pneumatic connector 32 that can be accessed and connected to a positive pneumatic line 92 outside the outer supply container 22.

[0063] The outer supply container 22 is reusable and, in one embodiment, includes one or more level sensors 34 located at the bottom of the container for sensing when the PD fluid located within the inner PD fluid supply container 40 is almost completely gone (delivered to the patient). The sensor 34 can be any type of sensor that is capable of detecting the presence of PD fluid or air through the wall of the inner PD fluid supply container. The sensor 34 can be, for example, an ultrasonic sensor, a magnetic sensor, a capacitive sensor, or an inductive sensor. The outer supply container 22 and the inner PD fluid supply container 40 are sized here so that, at their bottoms, the inner PD fluid supply container 40 is tightly held within the outer supply container 22 so that the sensor 34 is always pressed against the wall of the inner fluid supply container 40 to provide an accurate output signal.

[0064] The PD fluid supply assembly 20 in one embodiment also includes a backpack 50 that is worn by the patient and into which the outer supply container 22 and the nested inner PD fluid supply container 40 are placed while the patient moves from one location to another for whatever reason and while the patient is receiving treatment. The backpack 50 and the enclosed outer and inner PD fluid supply containers 22, 40 can be removed from the patient and placed next to the patient (e.g., during treatment, when the patient has arrived at a destination where the patient needs to remain stationary for a period of time). The backpack 50 can also include structure such as one or more hooks 52 for hanging the outer and inner containers, such as having one or more holes 38 for receiving the one or more hooks, so that the bottom of the outer supply container 22 is raised from the bottom of the backpack 50 during operation. In an alternative embodiment, the outer supply container 22 and the nested inner container 40 are supported by the bottom of the backpack 50 during operation.

[0065] The PD fluid supply assembly 20 may also include: one or more clips 54, such as a PD fluid supply clip, for clamping the PD fluid supply line 44; and a pneumatic line clip 56 for clamping the positive pneumatic line 92 leading to the external supply container 22. The PD fluid supply clip 54 and the pneumatic line clip 56 may be fixed, for example, to the inner surface of the backpack 50, wherein the patient, when placing the wearable PD system 10 for use, places the PD fluid supply line 44 and the positive pneumatic line 92 into the PD fluid supply clip 54 and the pneumatic line clip 56, respectively, wherein the lines 44, 92 are kept fixed to the clips 54, 56 during treatment, and until the patient removes the lines after treatment.

[0066] The PD fluid supply assembly 20 may further include a heater or warmer 60, such as a heating blanket or warming blanket, located within the backpack 50. In one embodiment, the heater or warmer 60 is configured to heat itself to patient temperature, such as 37°C, which brings the PD fluid to or near patient temperature in an efficient manner within the closed environment of the backpack 50 without the possibility of overheating. Similar to the level sensor, the outer supply container 22 may be provided with one or more temperature sensors 36 to contact the inner PD fluid supply container 40 to obtain the temperature of the PD fluid contained therein. A simple on / off temperature control may be used, such that the heater or warmer 60 is powered on until the one or more temperature sensors 36 read 37°C, after which the heater or warmer is powered off until the one or more temperature sensors 36 read an acceptable lower temperature, such as 32°C, after which the above cycle is repeated.

[0067] The pumping unit 70 of the wearable PD system 10 of the present disclosure in one embodiment includes an air pump or pneumatic pump 72 having a positive pressure outlet 72p and a negative pressure outlet 72n. Suitable air pumps for the air pump 72 include those found in portable blood pressure machines, which can be powered by a battery. The pumping unit 70 also includes a control unit 80, which includes one or more processors 82, one or more memories 84, and possibly a video controller 86 for displaying information on a user interface 88. The control unit 80 controls: whether the air pump 72 is pumping; whether each clip 54, 56, 114, 118 is open or closed; and whether the heater or warmer 60 (if provided) is powered. The control unit 80 also receives outputs from any sensors 34, 36 associated with the wearable PD system 10. The pumping unit 70 can be located in a backpack 50 or worn elsewhere by the patient, such as on the patient's belt.

[0068] As mentioned above, the control unit 80 of the pumping unit 70 provides a user interface 88, or operates with the user interface 88. For example, if the pumping unit 70 is worn on the patient's belt, the user interface 80 can be located on the control unit 80. Here, the user interface 88 can include a touch screen display and / or one or more buttons (such as a membrane switch) to allow the patient to enter data and commands into the user interface. If the pumping unit 70 is located in the backpack 50, the user interface 88 can be provided as a mobile application, which is downloaded to the user's smartphone or tablet (smart device) 90 and played via the smartphone or tablet 90. Here, the control unit 80 also includes a transceiver for wireless two-way communication with the user's smartphone or tablet 90. When the mobile application is installed, the application is paired or registered with the control unit 80 of the wearable PD system 10 of the present disclosure, after which the smartphone 90 and the control unit 80 will only communicate with each other. In addition, after pairing or registration, when both the smartphone 90 and the control unit 80 are powered on, the mobile application and the control unit 80 will automatically synchronize.

[0069] The user interface 88 allows the patient to start treatment using the wearable PD system 10 of the present disclosure after placement. The user interface 88 allows the patient to pause or stop treatment at any time. When starting treatment, the user interface 88 can display a message to the patient to confirm that each of the PD fluid supply assembly 20, the pumping unit 70, and the PD fluid discharge assembly 100 has been placed and connected together. After receiving confirmation from the patient, the control unit 80 starts treatment and causes automatic operation of each of the air pump or pneumatic pump 72, the clamps 54, 56, 114, 118, and the PD fluid heater 60 or warmer (if provided).

[0070] Regarding pneumatic line connections, a positive pneumatic line 92 leading to the outer supply container 22 is connected to the positive pressure outlet 72p of the air pump or pneumatic pump 72. A second negative pneumatic line 94 is provided and connected to the negative pressure outlet 72n of the air pump or pneumatic pump 72. The negative pneumatic line 94 leads to one or more outer leg containers 102 of the PD fluid discharge assembly 100. Each one or more outer leg containers 102 operate in conjunction with a nested inner PD fluid discharge container 120. In one embodiment, the outer leg container 102 and the inner PD fluid discharge container 120 are cylindrical so that they can be slid up onto one or both feet of the patient and rest around one or both legs of the patient. The outer leg container 102 can also be rigid (e.g., rigid plastic), or can be flexible, such as an airtight fabric such as canvas (or canvas with an inner rubber lining). If rigid, the outer leg container 102 includes an openable and sealable top 104 that allows an inner PD fluid drain container 120 to be placed within the outer leg container 102. The rigid top 104 and cylindrical body 106 of the outer leg container 102 can be sealed together via the closure of inner and outer O-rings 108 and one or more releasable latches 110 to hold the rigid top 104 and cylindrical body 106 together in a sealed manner. If flexible, the lid 104 can include an airtight outer zipper and inner O-ring seal for sealing the lid to the inner cylindrical wall of the cylindrical body 106 of the outer leg container 102. In addition, if made flexible, the outer leg containers 102 can each include one or more flexible hook and loop type fasteners for fastening the outer leg container to the patient's leg.

[0071] In one embodiment, the inner PD fluid drain container 120 is a flexible plastic container. The inner PD fluid drain container 120 is also cylindrical in shape and in one embodiment includes a drain line 122 that is welded or otherwise permanently connected to the container 120 so that the drain line 122 cannot be accidentally pulled out of the container while the patient is walking or otherwise moving. The lid 104 of the outer leg container 102 is provided with a stretchable spandex-like sealing sleeve 112 that allows a connector 122c located on the connection end of the drain line 122 to slide over the sealing sleeve 112, which then seals to the drain line 122.

[0072] The PD fluid drain assembly 100 also includes a drain clamp 114 for each drain line 122. In one embodiment, the drain clamp 114 is located at the cover 104 and clamps onto the corresponding drain line 122 just above the sealing sleeve 112. The patient inserts the drain line 122 into the drain clamp 114, which releasably holds the drain line 122 during treatment. The cover 104 of each outer leg container 102 is also provided with a pneumatic connector 116, which is used to connect to the negative pneumatic line 94 extending from the air pump or pneumatic pump 72. The cover 104 of each outer leg container 102 is also provided with a pneumatic clamp 118 for clamping the negative pneumatic line 94.

[0073] In one embodiment, the PD fluid supply assembly 20, pumping unit 70, and PD fluid discharge assembly 100 are each powered by a battery. In one embodiment, the battery power source is a rechargeable battery power source. A separate battery can be provided for each of the PD fluid supply assembly 20, pumping unit 70, and PD fluid discharge assembly 100. Here, no wires extending to the fluid and pneumatic clamps are required, and the clamps can be actuated wirelessly, for example, through the same WIFI network that allows the user interface 88 on the patient's smartphone or tablet (smart device) 90 to interact with the control unit 80. The patient can plug the recharging cord into each of the three separate batteries at the end of the day.

[0074] In the illustrated embodiment, a single battery 74 is provided by the pumping unit 70. Embedded and insulated wires or lines 96 are positioned along the interior surface of the backpack 50 and extend to the fresh PD fluid line clamp 54, the pneumatic line clamp 56, and the heater or warmer 60 (if provided). If the pumping unit 70 is located within the backpack 50, the patient does not need to make an electrical connection (for the line 96) between the pumping unit 70 and the PD fluid supply assembly 20. For example, if the pumping unit 70 is instead positioned along the patient's waist belt, the patient makes an electrical connection (for the line 96) between the pumping unit 70 and the PD fluid supply assembly 20. It is also contemplated that the negative pneumatic line 94 is positioned within the insulating sleeve 98, and that the wire 96 is also extended through the insulating sleeve to the lid 104 of each outer leg container 102. The wire 96 exits the sleeve 98 at the lid 104 and connects to each of the drain clamp 114 and the pneumatic line clamp 118. If the control unit 70 is located within the backpack 50, the negative pneumatic line 94, the electrical wires 96 and the cannula 98 can exit the backpack to be connected via an aperture 62 (e.g., Figure 1 ) to the fluid discharge assembly 100.

[0075] The disposable kit 130 of the wearable PD system 10 of the present disclosure includes: a nested inner PD fluid supply container 40 (e.g., a standard PD fluid container); a PD fluid supply line 44; one or more PD fluid drain lines 122; one or more PD fluid drain containers 120; and a line connection manifold 132. The line connection manifold 132 includes: a transfer kit connector 132t for connecting to a patient's PD fluid transfer kit; and at least one drain connector 132d for connecting to one or more PD fluid drain lines 122. In one embodiment, the PD fluid supply line 44 extends from the line connection manifold 132, extends through the opening 58 in the backpack 50, and extends to the supply connector 42 located at the nested inner PD fluid supply container 40. The PD fluid supply line 44 in an alternative embodiment is welded or otherwise permanently fixed to the nested inner PD fluid supply container 40, and is alternatively connected to a supply connector (not shown) located at the line connection manifold 132. In any case, the patient makes two and possibly three fluid connections, once to the supply connector 42 and once or twice to one or both of the drain connectors 132d of the line connection manifold 132 .

[0076] The patient also makes one or two pneumatic connections, once for each negative pneumatic line 94 and pneumatic connector 116 located at one or more outer leg containers 102. After treatment, the patient removes each drain line 122 from the line connection manifold 132 and removes the negative pneumatic line 94 from each outer leg container 102, so that each outer leg container 102 can be removed from the patient. It is contemplated that the positive pneumatic line 92 remains connected between the pumping unit 70 and the outer supply container 22 of the PD fluid supply assembly 20 (particularly if the pumping unit 70 is located within the backpack 50). If the pumping unit 70 is instead located at the patient's waist belt, it is contemplated that the patient is allowed to disconnect both the PD fluid supply line 44 (which can be manually clamped prior to removal) and the positive pneumatic line 92, so that the backpack 50 is then unfastened from the patient and can be removed and left behind after the patient is finished filling.

[0077] Any rigid components of system 10, such as outer supply container 22 (in one embodiment), outer leg container 102 (in one embodiment), the housing of pumping unit 70, and tubing connection manifold 132 may be made of plastic, such as polyvinyl chloride ("PVC"), polyethylene ("PE"), polyurethane ("PU"), or polycarbonate ("PC"), or may be made of metal, such as stainless steel. Any flexible components of system 10, such as PD fluid supply container 40, one or more PD fluid drain containers 120, PD fluid supply line 44, one or more drain lines 122, positive pneumatic line 92, and negative pneumatic line 94 may be made of medically safe materials, such as one or more plastics, e.g., PVC, PE, PU, ​​or other suitable non-PVC polymers.

[0078] If a heater or warmer 60 is provided, the control unit 80 may power the heater or warmer along with the external supply container 22 and the PD fluid supply container 40 located within the backpack 50 before making a therapy connection. If the heater 60 draws too much power from the battery 74, the backpack 50 may provide a separate AC plug (not shown) to power the heater or warmer 60. It is also contemplated that, instead of providing a heater 60, the patient may be instructed to store the PD fluid supply container 40 in a warm location.

[0079] After the fresh PD fluid is heated, the above connections are made, and the patient begins treatment using the user interface 88, the control unit 80 causes: (i) the PD fluid supply clamp 54 to open; (ii) the positive pressure pneumatic clamp 56 to open; and (iii) the air pump 72 to energize and pump positive pressure air to the outer supply container 22 of the PD fluid supply assembly 20. The positive air pressure can be, for example, 1.5 psig to 3.0 psig. The control unit 80 also briefly causes one of the drain clamps 114 to open and causes the user interface 88 to prompt the patient to look for fresh PD fluid in the line connection manifold 132 (indicating that the PD fluid supply line 44 has been primed). When the patient confirms at the user interface that the PD fluid supply line 44 has been primed, the user interface 88 next prompts the patient to open the manual valve of the patient's transfer kit. The positive pressure air pressurizes the space between the outer supply container 22 and the nested inner PD fluid supply container 40, forcing fresh PD fluid from the inner PD fluid supply container 22, through the PD fluid supply line 44, through the tubing manifold 132, through the patient's PD fluid transfer kit, and through the patient's indwelling catheter into the patient's peritoneal cavity. In one embodiment, the control unit 80 receives a signal from the fluid level sensor 34 indicating that the PD fluid supply container 40 is empty or nearly empty. The control unit 80 may: stop the air pump 72; or cause the air pump 72 to wait for a period of time, such as one or more minutes, before stopping the air pump 72 to ensure that the container 40 is empty.

[0080] In an alternative embodiment, the level sensor 34 is not provided, and instead the control unit 80 energizes the air pump 72 for a period of time sufficient to anticipate that all or substantially all of the fresh PD fluid has been delivered from the inner PD fluid supply container 40 to the patient's peritoneal cavity. It is contemplated that at any time during the patient's fill (perhaps near the end) the patient is allowed to press the stop button at the user interface 88 when the patient feels sufficiently full. When the patient's fill has been completed, the control unit 80 removes power from the PD fluid supply clamp 54 and the positive pressure pneumatic clamp 56, which in one embodiment are closed in a safe manner. The control unit 80 also removes power from the heater 60 (if provided, and if still energized at the end of the patient's fill).

[0081] After the air pump 72 is stopped, the control unit 80 starts a timed patient stay. The timed patient stay can last, for example, one to two hours. At any time while the patient is sitting or otherwise not moving, even during patient filling, the patient can remove the backpack 50 and place it next to the patient, for example, at or above the patient's peritoneal cavity so that gravity assists in patient filling. As discussed above, it may be feasible to unhook the patient from the backpack 50 after patient filling and during the patient stay.

[0082] When the timed patient stay ends as determined by the control unit 80, the control unit causes: (i) the one or more drain clamps 114 to open; (ii) the negative pressure pneumatic clamp 118 to open; and (iii) the air pump 72 to energize and pull negative pressure at the one or more outer leg containers 102. The negative pressure is applied to the one or more PD fluid drain containers 120 and is transmitted to the spent PD fluid residing in the patient through the one or more drain lines 122, the line connection manifold 132, the patient's transfer kit, and the patient's indwelling catheter. The negative pneumatic pressure thus helps to cause the spent PD fluid to flow from the patient's peritoneal cavity to the one or more PD fluid drain containers 120, the flow being assisted by gravity. In one embodiment, the control unit 80 energizes the air pump 72 for a period of time sufficient to anticipate that all or substantially all of the spent PD fluid has been drained from the patient's peritoneal cavity to the one or more PD fluid drain containers 120. It will be appreciated that once a steady stream of spent PD fluid has flowed to the drain containers 120 due to gravity, the air pump 72 may be de-energized. Depending on the size of the PD fluid supply container 40 (e.g., two liters), it may be desirable to provide two PD fluid drain containers 120, for example, each holding one liter of used PD fluid plus the expected patient ultrafiltration volume, so that the weight of the used PD fluid in each leg is reduced and more evenly distributed.

[0083] Figure 2A patient is shown wearing one embodiment of the wearable PD system 10 of the present disclosure. The patient wears a backpack 50 that is part of the PD fluid supply assembly 20. The backpack 50 stores an outer supply container 22 and a nested inner PD fluid supply container 40, wherein the outer supply container 22 includes a bracket that defines one or more holes 38 that are suspended from hooks 52 extending from an inner surface of the backpack 50. Thus, a pumping unit 70 including an air pump 72, a control unit 80, and a battery 74 can be located below the outer supply container 22 and the nested inner PD fluid supply container 40. A PD fluid supply line 44 connected to a supply connector 42 of the supply container 40 can also extend downward from the supply container and outward through the hole defined in the backpack 50, which is ideal because air will migrate to the top of the supply container and gravity will help to supply fresh PD fluid from the supply container to the patient's peritoneal cavity.

[0084] A heater or warmer 60 is provided and positioned on an inner wall of the backpack 50. For example, before the patient puts on the backpack 50 and moves, the heater 60 can be activated via a user interface 88 provided on a smart device 90. The heater can be powered via an AC plug (not shown), which also recharges the battery 74. The external supply container 22 includes one or more level sensors 34 for detecting when the level of fresh PD fluid in the supply container 40 drops to an empty or nearly empty condition. The external supply container 22 also includes one or more temperature sensors 36 for detecting the temperature of the fresh PD fluid in the supply container 40, for example for use during heating.

[0085] The positive pneumatic line 92 extends from the negative pressure outlet 72n of the air pump 72 and extends through the pneumatic line clamp 56. When the patient presses the "Start Fill" button on the user interface 88 of the smart device 90, the control unit 80 energizes the pneumatic line clamp 56 to open, and the air pump 72 delivers positive air pressure to the space between the outer supply container 22 and the nested inner PD fluid supply container 40, thereby pushing fresh PD fluid out of the PD fluid supply container. The control unit 80 energizes the PD fluid supply clamp 54 (at Figure 2 ) is energized to open to allow fresh PD fluid to flow through the PD fluid supply line 44.

[0086] The PD fluid supply line 44 extends to a line connection manifold 132 that is positioned adjacent to the patient's PD fluid transfer set. The line connection manifold 132 includes: a transfer set connector 132t for connecting to the patient's transfer set; and at least one drain connector 132d for connecting to at least one drain line 122. Figure 2Two discharge lines 122 are shown. One discharge line 122 extends to a nested inner PD fluid discharge container 120 (e.g. Figure 2 ), while another discharge line 122 extends to the other leg of the patient (at Figure 2 The nested inner PD fluid discharge container 120 on the upper surface is not visible. Figure 2 As shown in FIG, the drain line 122 extends through a stretchable spandex-like sealing sleeve 112 to a cylindrical PD fluid drain container 120. The sealing sleeve 112 is located on the top or lid 104 of the outer leg container 102, wherein the top or lid 104 is removably sealed to the cylindrical body 106 of the outer leg container in an airtight manner.

[0087] A pneumatic connector 116, a drain clamp 114, and a pneumatic clamp 118 are also provided or supported by the top or lid 104 of the outer leg container 102. The drain clamp 114 is configured to clamp the drain line 122 in a secure manner (same for all clamps herein, in one embodiment). When the control unit 80 in one embodiment initiates a patient drain, the drain clamp 114 is caused to open to allow spent PD fluid to flow through the drain line 122 into the PD fluid drain container 120.

[0088] The pneumatic clamp 118 is configured to clamp the pneumatic line 94 (located within the insulating sleeve 98 along with the wires 96 leading to the clamp) in a secure manner. When the control unit 80 initiates a patient drain, the pneumatic clamp 118 is caused to open to allow the negative pressure from the negative pressure outlet 72n of the air pump 72 to begin drawing the spent PD fluid from the patient into the drain line 122 where gravity then assists the spent PD fluid into the PD fluid drain container 120.

[0089] It should be understood that various changes and modifications of the present preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its expected advantages. Therefore, it is contemplated that such changes and modifications are covered by the appended claims.

Claims

1. A wearable peritoneal dialysis ("PD") system comprising: A PD fluid supply assembly, the PD fluid supply assembly comprising: External supply containers; and an inner PD fluid supply container sealed within the outer supply container; a pumping unit, the pumping unit comprising an air pump having a positive pressure outlet and a negative pressure outlet; A PD fluid discharge assembly, the PD fluid discharge assembly comprising: at least one outer leg container configured to be worn about a leg of a patient; and at least one inner PD fluid drain container sealed within said at least one outer leg container; and A control unit configured to: (i) supply positive pneumatic pressure from the positive pressure outlet to the outer supply container to force fresh PD fluid to flow from the inner PD fluid supply container to the patient; and (ii) supply negative pneumatic pressure from the negative pressure outlet to the at least one inner container to force used PD fluid to flow from the patient toward the inner PD fluid discharge container.

2. The wearable PD system according to claim 1, wherein: The control unit is configured so as to: (i) supply positive pneumatic pressure during patient filling; and (ii) supplying negative pneumatic pressure during patient expulsion.

3. The wearable PD system according to claim 1, wherein: The control unit is located within the pumping unit.

4. The wearable PD system according to claim 1, wherein: The outer supply container is configured to open and close around the inner PD fluid supply container, and wherein the outer supply container includes a sealing interface for sealing the PD fluid supply container within the outer supply container.

5. The wearable PD system according to claim 1, wherein: A supply connector extends from the inner PD fluid supply container through the outer supply container in a sealed manner, and wherein a PD fluid supply line extends from the supply connector toward a PD fluid transfer set carried by the patient.

6. The wearable PD system according to claim 5, comprising a PD fluid supply clamp under the control of the control unit, and wherein, The PD fluid supply line extends through the PD fluid supply clamp.

7. The wearable PD system of claim 5, comprising a tubing connection manifold in fluid communication with the PD fluid transfer kit, and wherein: The PD fluid supply lines extend to the line connection manifold.

8. The wearable PD system according to claim 1, wherein: The at least one drain line extends in a sealed manner from the at least one inner PD fluid drain container, through the at least one outer leg container and toward a PD fluid transfer set carried by the patient.

9. The wearable PD system according to claim 8, comprising at least one ejection clip under the control of the control unit, and wherein, The at least one drain line extends through the at least one drain clamp.

10. The wearable PD system of claim 8, comprising a tubing connection manifold in fluid communication with the PD fluid transfer kit, and wherein: The at least one discharge line extends to the line connection manifold.

11. The wearable PD system according to claim 8, wherein: The at least one drain line extends from the at least one inner PD fluid drain container through the stretchable sealing sleeve of the at least one outer leg container in a sealed manner.

12. The wearable PD system of claim 1, comprising a positive pneumatic line extending from the positive pressure outlet to the external supply container.

13. The wearable PD system according to claim 12, comprising a pneumatic line clamp under the control of the control unit, and wherein, The positive pneumatic line extends through the pneumatic line clamp.

14. The wearable PD system of claim 1, comprising at least one negative pneumatic line extending from the negative pressure outlet to the at least one outer leg container.

15. The wearable PD system according to claim 14, comprising at least one pneumatic line clamp under the control of the control unit, and wherein, The at least one negative pneumatic line extends through the at least one pneumatic line clamp.

16. The wearable PD system according to claim 14, wherein: The at least one negative pneumatic line extends to a sealable lid of the at least one outer leg container.

17. The wearable PD system according to claim 14, wherein: The at least one negative pneumatic line extends along with electrical wires through at least one insulating sleeve to the at least one outer leg container.

18. The wearable PD system according to claim 1, wherein: The outer supply container, the inner PD fluid supply container, and optionally (i) the pumping unit and (ii) the control unit are located in a backpack that can be worn by the patient.

19. The wearable PD system of claim 18, comprising a heater or warmer disposed within the backpack, the heater or warmer being positioned and arranged to heat fresh PD fluid within the inner PD fluid supply container.

20. The wearable PD system according to claim 1, comprising a mobile application provided on a smart device in data communication with the control unit, the mobile application providing a user interface for the wearable PD system.

21. A wearable peritoneal dialysis ("PD") system comprising: A PD fluid supply assembly, the PD fluid supply assembly comprising: External supply containers; and an inner PD fluid supply container sealed within the outer supply container; Air pump; a control unit configured to cause positive pneumatic pressure to be supplied from the air pump to the outer supply container to force fresh PD fluid to flow from the inner PD fluid supply container to the patient; and A backpack wherein the outer supply container, the inner PD fluid supply container, and optionally the air pump and the control unit are located within the backpack.

22. The wearable PD system of claim 21, comprising at least one outer leg container and at least one inner PD fluid drain container, wherein: The at least one outer leg container is configured to be worn around a patient's leg, and the at least one inner PD fluid drain container is sealed within the at least one outer leg container, wherein the air pump includes a positive pressure outlet and a negative pressure outlet, and wherein the control unit is configured to: (i) supply positive pneumatic pressure from the positive pressure outlet to the outer supply container to force fresh PD fluid to flow from the inner PD fluid supply container to the patient; and (ii) supply negative pneumatic pressure from the negative pressure outlet to the at least one inner container to force used PD fluid to flow from the patient toward the at least one inner PD fluid drain container.

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