Automated peritoneal dialysis system with machine docking station

Abstract

A peritoneal dialysis ("PD") system includes a PD machine and a docking station connected to the PD machine via a power line. The docking station includes: a plurality of connectors configured to receive cables of one or more wired peripheral entities; a transceiver for wirelessly communicating with one or more wireless peripheral entities; and a power source rated to power the PD machine during a PD treatment including bulk or inline PD fluid heating.

Description

Technical Field

[0001] The present disclosure generally relates to medical fluid therapy and, more particularly, to dialysis fluid therapy. Background Art

[0002] For various reasons, a person's renal system may fail. Renal failure can produce a variety of physiological disorders. The ability to balance water and minerals or excrete the daily metabolic load is no longer possible. Toxic end products of metabolism (such as urea, creatinine, uric acid, and other substances) may accumulate in the patient's blood and tissues.

[0003] Dialysis is used to treat decreased renal function, particularly renal failure. Dialysis removes waste products, toxins, and excess water from the body that would normally be removed by a functioning kidney. Dialysis treatment to replace renal function is critical for many people because this treatment is life-saving.

[0004] One type of renal failure therapy is hemodialysis ("HD"), which typically uses diffusion to remove waste from the patient's blood. A diffusion gradient occurs across a semi-permeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to cause diffusion.

[0005] 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 replacement or substitution fluid to the extracorporeal circuit during treatment. During the course of an HF treatment, the replacement fluid and the fluid that accumulates between the patient and the treatment are ultrafiltered, providing a convective transport mechanism that is particularly beneficial for removing medium and large molecules.

[0006] Hemodiafiltration ("HDF") is a treatment modality that combines convective clearance and diffusive clearance. HDF uses dialysis fluid flowing through a dialyzer (similar to standard hemodialysis) to provide diffusive clearance. In addition, a substitution solution is provided directly to the extracorporeal circuit to provide convective clearance.

[0007] Most HD, HF, and HDF treatments are performed in a center. There is a trend toward home hemodialysis ("HHD") nowadays, partly because HHD can be performed daily, which provides therapeutic benefits compared to in-center hemodialysis treatments that are typically performed every two or three weeks. Studies have shown that more frequent treatments remove more toxins and wastes and reduce interdialytic fluid overload compared to patients receiving less frequent but potentially longer treatments. Patients receiving more frequent treatments do not experience as many down cycles (fluctuations in fluid and toxins) as in-center patients who have accumulated toxins over two or three days prior to treatment. In some areas, the nearest dialysis center may be many miles from the patient's home, which results in home treatment times taking up much of the day. Treatments at a center near the patient's home may also take up much of the patient's day. HHD can be performed at night or during the day while the patient is relaxed, working, or otherwise productive.

[0008] Another type of kidney failure therapy is peritoneal dialysis ("PD"), which injects a dialysis solution (also called dialysis fluid) into the peritoneal cavity of the patient via a catheter. The dialysis fluid contacts the peritoneum within the peritoneal cavity of the patient. Wastes, toxins, and excess water pass from the patient's bloodstream through capillaries in the peritoneum and enter the dialysis fluid due to diffusion and osmosis, i.e., an osmotic gradient appears across the peritoneum. Osmotic agents in the PD fluid provide the osmotic gradient. The used or spent dialysis fluid is drained from the patient's body, thereby removing wastes, toxins, and excess water from the patient's body. This cycle is repeated, e.g., multiple times.

[0009] There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects the implanted catheter to the drain tube to allow the used or spent dialysis fluid to drain from the peritoneal cavity. Then, the patient switches the fluid connection so that the patient catheter is connected to a fresh dialysis fluid bag to inject fresh dialysis fluid through the catheter and into the patient's body. The patient disconnects the catheter from the fresh dialysis fluid bag and allows the dialysis fluid to dwell in the peritoneal cavity, where the transfer of wastes, toxins, and excess water occurs. After the dwell period, the patient repeats the manual dialysis procedure, e.g., four times a day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving much room for improvement.

[0010] The similarities between APD and CAPD are that the dialysis treatment includes drain, fill, and dwell cycles. However, the PD machine typically performs these cycles automatically while the patient is sleeping. The PD machine enables the patient to not have to perform the treatment cycles manually nor have to infuse supplies during the day. The PD machine is fluidly connected to an implanted catheter, a fresh dialysis fluid source or bag, and a fluid drain tube. The PD machine pumps fresh dialysis fluid from the dialysis fluid source through the catheter and into the patient's peritoneal cavity. The PD machine also allows the dialysis fluid to dwell in the peritoneal cavity and allows for the transfer of waste, toxins, and excess water. The source can include multiple liters of dialysis fluid, including multiple solution bags.

[0011] The PD machine pumps used or spent dialysis fluid from the patient's peritoneal cavity through the catheter for drainage. As with the manual process, several drain, fill, and dwell cycles occur in the dialysis device. A "last fill" may occur at the end of PD treatment. The fluid from the last fill can be retained in the patient's peritoneal cavity until the next treatment begins or can be manually drained at some point during the day.

[0012] Any of the above renal failure therapy machines are provided in different versions and / or varieties, but especially the PD machine. Different markets have different requirements, resulting in different versions of the same PD machine. Additionally, new PD machines are developed from time to time in an attempt to improve older PD machines. However, older PD machines are still on the market because PD machines typically last a long time and may be preferred by some patients or clinicians who are already very familiar with the older PD machines. Adding full updates and features to different PD machines and different versions of the same PD machine has proven to be problematic. Different machines and different machine versions may have different processors and memories and have different types and levels of complexity of connectivity. For example, they may or may not have wireless communication capabilities.

[0013] For the reasons above, there is a need for improved PD systems and related methods. Summary of the Invention

[0014] The present disclosure describes an automated peritoneal dialysis (“PD”) system and associated methods, where a PD machine operates with a docking station. The docking station provides appropriate power and data communication to the PD machine or cycler. In an embodiment, the power cable is the only line from the docking station to the PD machine. In one embodiment, the cable is a multi-conductor or cable that includes power conductors (e.g., multiple strands) and data conductors. The PD machine or cycler includes a connector or port that is configured to receive the multi-conductor or cable and communicate electrically separately with the power conductors and the data conductors. In this way, the power carried by the power conductors can pass through the required power conversion circuitry (transformer, rectification, etc.) within the PD machine, while the data carried by the data conductors is delivered to / from the control unit of the PD machine. However, it should be understood that the docking stations of the present disclosure are not limited to PD machines having connectors or ports configured to receive multi-conductors or cables. Embodiments of docking stations for operating with older such PD machines are discussed herein.

[0015] The docking station includes a plurality of connectors / ports, such as one or more of the following: Universal Serial Bus (“USB”, including USB-A, USB-B, USB-C, USB3.0) connectors / ports; High-Definition Multimedia (“HDMI”) connectors / ports; RCA connectors / ports; 3.5 mm audio connectors / ports; Ethernet connectors / ports; SD card reader connectors / ports; microSD reader connectors / ports; DisplayPort connectors / ports, Deutsches Institut für Normung (“DIN”) connectors (including all types of DIN connectors); D connectors; and new connectors for new or existing communication protocols for future development. The connectors / ports are electrically connected to the control unit of the docking station. The control unit includes one or more processors, one or more memories, and a transceiver for two-way wireless data communication between the control unit and any wireless peripheral entity / device operating with the docking station.

[0016] The docking station is configured to connect to many different types of peripheral entities, such as blood pressure monitors, weighing scales, glucose monitors, oxygen monitors, and other medical monitors, the Internet, local area networks and wide area networks, smart phones, and cellular phones. Any peripheral entity can be wirelessly connected to the docking station. Certain peripheral entities can be placed in wired communication with the docking station, such as blood pressure monitors, weighing scales, glucose monitors, oxygen monitors, and other medical monitors.

[0017] Certain peripheral entities, such as blood pressure monitors, weighing scales, glucose monitors, oxygen monitors, and other medical monitors, operate with a docking station that does not interact with the PD machine, i.e., independently of the communication between the docking station and the PD machine or the cycler. Here, the docking station is independent of the peripheral entity and, in one embodiment, operates without the PD machine even knowing about the interaction. When a medical monitor is connected to the docking station in a wired manner, in one embodiment, the medical monitor in a plug-and-play ("PnP") configuration has its own software and provides drivers such that the control unit of the docking station can automatically and dynamically identify the type of the medical monitor (e.g., blood pressure monitor, weighing scale, glucose monitor, oxygen monitor) and assign the medical monitor to the corresponding connector / port of the docking station. The PnP medical monitor also loads one or more required drivers into the control unit of the docking station, enabling the docking station to appropriately interact with the specific type of medical monitoring data supplied to the docking station.

[0018] When a medical monitor is connected to the docking station in a wireless manner, the medical monitor first undergoes a pairing routine so that the output from the medical monitor, e.g., in a clinical environment where there may be multiple PD machines and docking stations, is transmitted only to the correct docking station. Pairing can occur by placing a "pairing" button on the docking station. When the button is pressed, the transceiver of the docking station sends a signal that the wireless medical monitor recognizes and synchronizes to. Thereafter, any and all output from the wireless medical monitor is sent to the paired docking station.

[0019] Second, the appropriate drivers and wireless medical monitoring software required to operate with the wireless medical monitor are sent wirelessly to the docking station. To this end, the software application associated with the wireless medical monitor is downloaded to the user's smartphone, tablet, or other smart device. In one embodiment, both the docking station and the smart device are connected to an available wireless internet, such as WiFi. The wireless internet (e.g., WiFi) enables the appropriate drivers and wireless medical monitoring software to be downloaded from the application software associated with the wireless medical monitor to the control unit of the docking station. In an alternative embodiment, the application software is downloaded directly from the medical monitor wirelessly to the docking station. In any case, the appropriate drivers and wireless medical monitoring software notify the control unit of the docking station about the type of the medical monitor, e.g., blood pressure monitor, weighing scale, glucose monitor, oxygen monitor, etc. The drivers and wireless medical monitoring software also enable the docking station to appropriately interact with the specific type of medical monitoring data supplied to the docking station. The download of the above software application can alternatively be performed in a wired manner, e.g., by connecting a storage stick or flash drive to one of the ports on the docking station.

[0020] The connection of the docking station to an available wired or wireless internet (e.g., WiFi) also enables the docking station to access the Internet. Through the Internet, the control unit of the docking station of the present disclosure can access a remote medical data acquisition and analysis connectivity platform, such as the Sharesource™ platform provided by the assignee of the present disclosure. The remote medical data acquisition and analysis connectivity platform enables the control unit of the docking station to connect with relevant clinicians and / or hospital systems. The remote medical data acquisition and analysis connectivity platform also provides data record sheets or pages that are filled with medical treatment / monitoring data from the docking station and are accessible by relevant clinicians and / or hospital systems for review by the clinicians and / or physicians.

[0021] Based on the medical monitoring data, the clinician can determine that one or more of the patient's PD treatment prescriptions need to be updated or may need to be replaced. The remote medical data acquisition and analysis connectivity platform allows the updated or replacement PD treatment prescriptions to be delivered to the control unit of the docking station. The delivery of the updated or replacement PD treatment prescription from the docking station to the control unit of the PD machine depends on the age and communication capabilities of the PD machine.

[0022] Many older PD machines that are still in use and are still being manufactured and sold as new do not have wired or wireless connectivity capabilities. However, most of these PD machines have a data port for receiving a memory stick or flash drive (or other removable memory device) to download treatment data to and receive new treatment prescription data from the memory stick or flash drive. In the past, PD patients had to transport a memory stick or flash drive with treatment data to a hospital or clinic where a doctor or clinician would use the memory stick or flash drive to upload the treatment data to their system, create an updated or new PD treatment prescription, save the updated or new PD treatment prescription to the memory stick or flash drive, and the patient would then transport the memory stick or flash drive back to the PD machine to install the updated or new treatment prescription.

[0023] The docking station of the present disclosure is instead located near the PD machine. The patient only needs to insert a memory stick, flash drive, or other removable storage device into the docking station, download the updated or new treatment prescription to the memory stick or flash drive, and insert the memory stick or flash drive into the adjacent PD machine to install the updated or new treatment prescription. Similarly, treatment data can be downloaded from the control unit of the PD machine to a memory stick or flash drive and then inserted into the adjacent docking station where the treatment data is uploaded to the control unit of the docking station and can then be delivered via the remote medical data acquisition and analysis connectivity platform to the system of the appropriate doctor or clinician.

[0024] Newer PD machines have wireless capabilities that allow the control unit of the newer PD machines to: (i) connect directly via the Internet to a telemedicine data acquisition and analysis connectivity platform to share updated or new treatment prescriptions (to the PD machine) and treatment data (to the doctor or clinician) with the doctor's or clinician's system, or (ii) connect wirelessly to a docking station that in turn connects via the Internet to the telemedicine data acquisition and analysis connectivity platform to share updated or new treatment prescriptions (to the PD machine) and treatment data (to the doctor or clinician) with the doctor's or clinician's system.

[0025] It is also envisioned that the docking station is configured to send and / or relay text messages (SMS or MMS messages) from a doctor's or clinician's cellular phone to the patient, for example. In another example, the docking station is configured to relay a wired or wireless alert sent from the PD machine to the docking station to the doctor's or clinician's cellular phone and / or to the service technician of the PD machine or cycler via an SMS or MMS message in certain treatment or PD machine conditions. Additionally, warning a doctor, clinician, and / or technician about a certain treatment or machine (e.g., alert) condition is not explicitly limited to SMS or MMS messaging and can be done via other wired or wireless communication protocols.

[0026] The docking station of the present disclosure enables existing PD machines to be used in a system with new advancements in one or more of the following aspects: (i) medical monitoring, (ii) PD treatment procedures, (iii) data communication, and (iv) data connectivity with their existing hardware and connectivity. Different docking stations can be provided that are tailored to the specific age, capabilities, and regional requirements of the PD machine or customized for the PD machine. Additionally, as technology advances, new and updated docking stations can be provided while allowing the continued use of existing and patient-familiar cyclers.

[0027] According to the disclosure set forth herein, and without limiting the disclosure in any way, in a first aspect that can be combined with any other aspect or portion thereof, a peritoneal dialysis ("PD") system includes a PD machine and a docking station connected to the PD machine via a power line, wherein the power line is configured to bring power and optional data to the PD machine. The docking station includes: a plurality of connectors configured to receive cables of one or more wired peripheral entities; a transceiver for wireless communication with one or more wireless peripheral entities; and a power supply rated to supply sufficient power to power the PD machine during PD treatment, which includes batch or inline PD fluid heating.

[0028] In a second aspect of the present disclosure that can be combined with any other aspect or portion thereof, the power line is the only physical connection between the PD machine and the docking station.

[0029] In a third aspect of the present disclosure that can be combined with any other aspect or portion thereof, the PD system is configured such that the PD machine can be connected to multiple different versions or types of docking stations.

[0030] In a fourth aspect of the present disclosure that can be combined with any other aspect or portion thereof, the PD system further includes one or more wired and wireless peripheral devices, including at least one medical monitor, the Internet, the internet, a smart device, or a cellular phone.

[0031] In a fifth aspect of the present disclosure that can be combined with any other aspect or portion thereof, the PD machine and the docking station each include a computer memory connector. The control unit of the PD machine communicates with the PD machine computer memory connector, and the control unit of the docking station communicates with the docking station computer memory connector. Additionally, a memory stick is used to transfer data between the control unit of the PD machine and the control unit of the docking station via the respective computer memory connectors.

[0032] In a sixth aspect of the present disclosure that can be combined with any other aspect or portion thereof, the data includes PD treatment data from the PD machine and one or more PD treatment prescriptions from the docking station.

[0033] In a seventh aspect of the present disclosure that can be combined with any other aspect or portion thereof, the PD system further includes a clinician and / or a hospital system. Additionally, the docking station is configured to (i) transmit PD treatment data to the clinician and / or the hospital system, and (ii) receive one or more PD treatment prescriptions from the clinician and / or the hospital system.

[0034] In an eighth aspect of the present disclosure that can be combined with any other aspect or portion thereof, the docking station is configured to transmit to and receive from the clinician and / or the hospital system via at least one of the Internet or a data acquisition and analysis connectivity platform.

[0035] In a ninth aspect of the present disclosure that can be combined with any other aspect or portion thereof, the PD machine is configured to wirelessly communicate with the docking station to transfer data between the PD machine and the docking station.

[0036] In a tenth aspect of the present disclosure that can be combined with any other aspect or portion thereof, the data includes PD treatment data from the PD machine and one or more PD treatment prescriptions from the docking station.

[0037] In an eleventh aspect of the present disclosure, which can be combined with any other aspect or part thereof, the PD system further includes a clinician and / or a hospital system. Additionally, the docking station is configured to (i) transmit PD treatment data to the clinician and / or the hospital system, and (ii) receive one or more PD treatment prescriptions from the clinician and / or the hospital system.

[0038] In a twelfth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the PD system further includes a clinician and / or a hospital system. Additionally, the PD machine is configured to wirelessly communicate with the clinician and / or the hospital system to transfer data between the PD machine and the clinician and / or the hospital system.

[0039] In a thirteenth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the data includes PD treatment data from the PD machine and one or more PD treatment prescriptions from the clinician and / or the hospital system.

[0040] In a fourteenth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the PD machine is configured to wirelessly communicate with the clinician and / or the hospital system via at least one of the Internet or a data acquisition and analysis connectivity platform.

[0041] In a fifteenth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the PD system further includes an intelligent service connector configured to connect to the PD machine while waiting for service at a service center, and the intelligent service connector is configured to identify at least one action or repair required by the PD machine before starting the service.

[0042] In a sixteenth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the intelligent service connector is configured to be inserted into the computer memory connector of the PD machine.

[0043] In a seventeenth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the intelligent service connector is configured to actuate at least one component of the PD machine to test the at least one component.

[0044] In an eighteenth aspect of the present disclosure, which can be combined with any other aspect or part thereof, the intelligent service connector includes a rechargeable battery configured to be recharged by the PD machine.

[0045] In a nineteenth aspect of the present disclosure, in combination with Figures 1 to 3 any features, functions, and alternatives described in any one or more of the figures can be combined with Figures 1 to 3 any features, functions, and alternatives described in any other figure and / or any aspect listed herein.

[0046] Accordingly, an advantage of the present disclosure is to provide a peritoneal dialysis system with a universal docking station that can be connected and used together with different PD machines and different versions of PD machines.

[0047] Another advantage of the present disclosure is to provide a PD system that adapts to new technologies and functions without having to change or upgrade the PD machine.

[0048] Another advantage of the present disclosure is to provide a PD system that further extends the life cycle of the PD machine.

[0049] Yet another advantage of the present disclosure is to provide a PD system that allows for different functions to be implemented, for example, for different markets and regions, without having to provide different versions of the same PD machine.

[0050] Yet another advantage of the present disclosure is to provide a PD system that is more easily adaptable to changes in data communication and protocols.

[0051] In addition, an advantage of the present disclosure is to provide a system having a PD machine and a docking station, where only one wire or cable is connected between the PD machine and the docking station.

[0052] Additional features and advantages are described in the following detailed description and the drawings and will become apparent from the following detailed description and the drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those of ordinary skill in the art from the drawings and the description. Moreover, any particular embodiment need not have all of the advantages listed herein, and it is expressly contemplated that the various advantageous embodiments may be claimed separately. In addition, it should be noted that the language used in this specification has been selected primarily for readability and guidance purposes and not to limit the scope of the inventive subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 is a schematic diagram of an embodiment of the system of the present disclosure, which system includes a PD machine, a docking station, a remote medical data acquisition and analysis connectivity platform, and associated clinicians and / or hospital systems.

[0054] Figure 2 is a perspective view of an embodiment of the docking station of the present disclosure.

[0055] Figure 3 is a schematic diagram of an embodiment of an intelligent service connector that can be operated simultaneously with a PD machine at a service center or warehouse. DETAILED DESCRIPTION

[0056] System Overview

[0057] Now referring to the drawings and specifically toFigure 1 and Figure 2 , the present disclosure describes an automated peritoneal dialysis ("PD") system 10 and associated methods, where the PD machine 20 operates with a docking station 110. The PD machine 20 includes a housing 22, and the docking station 110 includes a housing 112. In various embodiments, all rigid and flexible components of the housings 22 and 112 can be made of one or more plastics, such as polyvinyl chloride ("PVC") or non-PVC materials, such as polyethylene ("PE"), polyurethane ("PU"), polycarbonate ("PC"), and / or polyetheretherketone ("PEEK"). The housings 22 and 112 can alternatively or additionally be made of any one or more metals, such as stainless steel, steel, and / or aluminum. In the illustrated embodiment, the docking station 110 supplies appropriate power to the PD machine 20. In an embodiment, the power cable or wire 114 is the only line from the docking station 110 to the PD machine 20.

[0058] In one embodiment, the cable or wire 114 is a multi-conductor or cable or wire that includes power conductors (e.g., multiple strands) and data conductors. The PD machine or cycler 20 includes a connector or port 24 that is configured to receive the multi-conductor or cable or wire 114 and communicate electrically separately with the power conductors and the data conductors. In this way, the power carried by the power conductors can pass through the required power conversion circuits (transformers, rectifiers, etc.) within the PD machine 20, while the data carried by the data conductors is delivered to / from the control unit 30 of the PD machine 20. However, it should be understood that the docking station 110 of the present disclosure is not limited to PD machines having a connector or port configured to receive a multi-conductor or cable. Embodiments of the docking station 110 that operate with older such PD machines 20 are discussed herein.

[0059] The docking station 110 includes a plurality of ports or connectors 116a to 116n for receiving a wire or cable from a peripheral device 130, such as one or more of the following: Universal Serial Bus ("USB", including USB-A, USB-B, USB-C, USB3.0) port / connector; High-Definition Multimedia ("HDMI") port / connector; RCA port / connector; 3.5mm audio port / connector; Ethernet port / connector; SD card reader port / connector; microSD reader port / connector; DisplayPort port / connector; Deutsches Institut für Normung ("DIN") connector (including all types of DIN connectors); D connector; and new connectors for new or existing communication protocols for future development. The ports or connectors 116a to 116n can have, for example, a rated power of up to 70 amperes. In one embodiment, the ports or connectors 116a to 116n have the ability to transmit signals, data, and power along the connecting wires in the same connector. The ports or connectors 116a to 116n are electrically connected to the control unit 120 of the docking station 110. The control unit 120 includes one or more processors 122, one or more memories 124, and a transceiver 126 for two-way wireless data communication between the control unit 120 and any wireless peripheral device operating with the docking station 110.

[0060] The docking station 110 is configured to connect (either wired to the ports or connectors 116a to 116n or wirelessly) to many different types of peripheral entities 130, such as a blood pressure monitor 132b, a weighing scale 132w, a glucose monitor 132g, an oxygen monitor 132o, and other medical monitors 132, the Internet 134, local area and wide area networks 136, smart phones and other smart devices (tablet computers, etc.) 138s, and cellular phones 138c (e.g., via a cellular phone tower 138t). Any peripheral entity 130 can be wirelessly connected to the docking station 110. Certain peripheral entities 130 can be placed to communicate with the docking station 110 either wired or wirelessly, such as the blood pressure monitor 132b, the weighing scale 132w, the glucose monitor 132g, the oxygen monitor 132o, other medical monitors 132, the Internet 134, and local area and wide area networks 136.

[0061] Certain peripheral entities 130, such as blood pressure monitor 132b, weight scale 132w, glucose monitor 132g, oxygen monitor 132o, and other medical monitors 132, operate with docking station 110 without the docking station interacting with PD machine 20. Here, docking station 110 is independent of peripheral entities 130 and, in one embodiment, operates without the PD machine 20 even being aware of the interaction. When the medical monitor 132 is connected to the docking station 110 in a wired manner, in one embodiment, the medical monitor in a Plug and Play (“PnP”) configuration has its own software and provides drivers such that the control unit 120 of the docking station 110 can automatically and dynamically identify the type of medical monitor 132 (e.g., blood pressure monitor 132b, weight scale 132w, glucose monitor 132g, oxygen monitor 132o) and assign the medical monitor to the corresponding ports 116a to 116n of the docking station 110. The PnP medical monitor 132 also loads one or more required drivers into the control unit 120 of the docking station 110 such that the docking station can appropriately interact with the specific type of medical monitoring data supplied to the docking station.

[0062] When the medical monitor 132 is connected to the docking station 110 in a wireless manner, the medical monitor first undergoes a pairing routine such that the output from the medical monitor is sent only to the correct docking station 110, for example, in a clinical environment where there may be multiple PD machines 20 and docking stations 110. Pairing can be performed by including a “pairing” button 140 on the docking station 110. When the “pairing” button 140 is pressed, the transceiver 126 of the docking station 110 transmits a signal that the wireless medical monitor 132 recognizes and synchronizes to. Thereafter, any and all output from the wireless medical monitor 132 is sent to the paired docking station 110.

[0063] Second, the appropriate drivers and wireless medical monitoring software required to operate with the wireless medical monitor 132 are wirelessly sent to the docking station 110. To this end, the software application associated with the wireless medical monitor 132 is downloaded to the user's smart phone, tablet, or other smart device 138. In one embodiment, both the docking station 110 and the smart device 138 are connected to an available wireless Internet 150 (e.g., WiFi). The wireless Internet 150 (e.g., WiFi) enables the appropriate drivers and wireless medical monitoring software to be downloaded from the application software associated with the wireless medical monitor 132 to the control unit 120 of the docking station 110. In an alternative embodiment, the application software is directly wirelessly downloaded from the medical monitor 132 to the docking station 110. In any case, the appropriate drivers and wireless medical monitoring software notify the control unit 120 of the docking station 110 about the type of the medical monitor 132, such as the blood pressure monitor 132b, the weighing scale 132w, the glucose monitor 132g, the oxygen monitor 132o, etc. The drivers and wireless medical monitoring software also enable the docking station 110 to appropriately interact with the specific type of medical monitoring data supplied to the docking station. The download of the above software application can alternatively be performed in a wired manner, e.g., by connecting a memory stick, a flash drive, or other removable memory device 28 to one of the ports or connectors 116a to 116n on the docking station 110.

[0064] The connection of the docking station 110 to the available wired or wireless Internet 150 (e.g., WiFi) also enables the docking station 110 to access the Internet 134. Through the Internet 134, the control unit 120 of the docking station 110 of the system 10 can access a remote medical data acquisition and analysis connectivity platform 160, such as the ShareSource™ platform provided by the assignee of the present disclosure. The remote medical data acquisition and analysis connectivity platform 160 enables the control unit 120 of the docking station 110 to connect to the relevant clinicians and / or hospital systems 170. The remote medical data acquisition and analysis connectivity platform 160 also provides a data record form or page 162, which is filled with the medical monitoring data from the docking station 110 and which can be accessed by the relevant clinicians and / or hospital systems 170 for clinician or doctor review.

[0065] A clinician may determine that one or more of the PD treatment prescriptions 164 for a patient need to be updated or may need to be replaced based on medical monitoring data. The telemedicine data acquisition and analysis connectivity platform 160 allows one or more updated or replacement PD treatment prescriptions 164 to be delivered to the control unit 120 of the docking station 110. Delivery of the one or more updated or replacement PD treatment prescriptions 164 from the docking station 110 to the control unit 30 of the PD machine 20 depends on the age and communication capabilities of the PD machine. The control unit 30 of the PD machine 20 varies according to the designed age of the PD machine and may include one or more processors 32, one or more memories 34, a user interface 36, and, if new enough, may include a transceiver 38 for wireless two-way communication with the control unit 120 of the docking station 110 and remote entities accessible via the Internet 134.

[0066] Many older PD machines 20 that are still in use and are still being manufactured and sold as new (e.g., PD machines that do not have a connector or port 24 capable of receiving a cable or wire 114 in a multi-conductor or wire version) do not have wired or wireless connectivity capabilities. However, most older PD machines 20 have a computer memory or data connector / port 26 for receiving a memory stick, flash drive, or other removable memory device 28 to download treatment data to and receive new treatment prescription data from the memory stick or flash drive. In the past, PD patients had to deliver a memory stick or flash drive 28 with treatment data to a hospital or clinic where a doctor or clinician would insert the memory stick or flash drive 28 into their computer to upload the treatment data from the memory stick to their system 170 and, if needed, form an updated or new PD treatment prescription 164, save the updated or new PD treatment prescription 164 to the memory stick or flash drive 28, and the patient would then deliver the memory stick or flash drive 28 back to the PD machine 20 to install the updated or new treatment prescription 164.

[0067] The docking station 110 of the present disclosure is instead located near the PD machine 20. The patient only needs to insert a memory stick, flash drive, or other removable memory device 28 into the docking station 110 that stores the updated or new prescription 164, download the updated or new treatment prescription to the memory stick or flash drive 28, and insert the memory stick or flash drive into the adjacent PD machine 20 to install the updated or new treatment prescription. Similarly, treatment data can be downloaded from the control unit 30 of the PD machine 20 to a memory stick or flash drive 28, which is then inserted into the adjacent docking station 110 where the treatment data is uploaded from the memory stick to the control unit 120 of the docking station and can then be delivered via the telemedicine data acquisition and analysis connectivity platform 160 to the system 170 of the appropriate doctor or clinician.

[0068] The newer PD machines 20 have wireless capabilities that allow the control unit 30 of the newer PD machines to: (i) connect directly via the Internet 134 to the telemedical data acquisition and analysis connectivity platform 160 to share updated or new treatment prescriptions (to the PD machine 20) and treatment data (to the doctor or clinician) with the doctor's or clinician's system 170, or (ii) connect wirelessly to the docking station 110, which in turn connects via the Internet to the telemedical data acquisition and analysis connectivity platform 160 to share updated or new treatment prescriptions (to the PD machine 20) and treatment data (to the doctor or clinician) with the doctor's or clinician's system 170.

[0069] It is also contemplated that the docking station 110 is configured to send and / or relay text messages (SMS or MMS messages) to the patient, for example, from the doctor's or clinician's cellular phone. In another example, the docking station 110 is configured to relay a wired or wireless alert sent from the PD machine 20 to the docking station 110 to the doctor's or clinician's cellular phone and / or to the service technician of the PD machine or cycler in certain treatment or PD machine conditions. Additionally, warning the doctor, clinician, and / or technician about a certain treatment or machine (e.g., alert) condition is not specifically limited to SMS or MMS messaging and can be done via other wired or wireless communication protocols.

[0070] The docking station 110 of the present disclosure enables existing PD machines 20 to be used in a system with new advancements in one or more of the following aspects with their existing hardware and connectivity: (i) medical monitoring, (ii) PD treatment procedures, (iii) data communication, and (iv) data connectivity. Different docking stations 110 can be provided that are customized for the specific age and capabilities of the PD machine 20, different market or regional requirements, and different patient environments. Additionally, as technology advances, new and updated docking stations 110 can be provided while allowing the continued use of the existing and patient-familiar cyclers.

[0071] The PD machine 20 may include and employ, as needed, batch (tray) heating via a batch heater or inline heating via an inline heater. In various embodiments, the power required to heat the PD fluid for treatment (e.g., body temperature of about 37 °C) is about 400 watts for batch (tray) heating and 450 watts for inline heating. It is envisioned that the power supply 118 of the docking station 110 is capable of meeting such power demands and has additional engineering margin above those requirements. Such power capabilities may be provided via a 25-ampere 24-volt DC power supply and / or via a 17-ampere 36-volt DC power supply (resulting in a total rated value of approximately 600 watts). It is also envisioned that the docking station 110 and the system 10 use a built-in battery (for backup power) within the PD machine 20 to serve as a reserve for peaks in power consumption (e.g., during heating). The docking station 110 can then recharge the built-in battery after the peak power consumption is complete.

[0072] In one embodiment, the docking station 110 of the system 10 provides, for example, automated production testing, calibration, and troubleshooting. The docking station 110 of the system 10 is provided with firewall security to ensure a secure and intact data stream between the docking station, the PD machine 20, and the telemedicine data acquisition and analysis connectivity platform 160, which may include any one or more of the following: (i) remotely prepared operating software updates delivered to the PD machine 20, (ii) remotely prepared patient treatment prescriptions delivered to the PD machine 20, (iii) machine and treatment data delivered from the PD machine 20 to a remote location, (iv) the docking station 110 waking up the PD machine 20 for any needed reason, (v) the docking station 110 being used to perform remote diagnostics on a patient, and (vi) enabling a patient to remotely start the PD machine 20 and begin treatment setup.

[0073] If the power supply 118 of the docking station 110 is damaged, it is not necessary to send the PD machine 20 for repair. Only a new or spare docking station 110 needs to be provided. It is envisioned that a smaller and simpler docking station 110 for travel is provided, which can be used as a backup docking station 110 if the power supply 118 (or any other component) of the main docking station is damaged and while waiting for a new main docking station 110 to be delivered. In the case of the long life cycle of the PD machine 20, the docking station 110 can be upgraded to accommodate new technologies and new communication protocols without changing or replacing the PD machine 20.

[0074] Now refer to Figure 3, it is also contemplated that system 10 provides an intelligent service connector 50 that is inserted into the PD machine 20 at the service center or warehouse 180 for repair, diagnosis, or testing. In an embodiment, the intelligent service connector 50 is inserted into the computer memory or data (e.g., USB) connector / port 26 of the PD machine 20 and remains with the PD machine at the service center or warehouse 180. The intelligent service connector 50 docks with the control unit 30 of the PD machine 20 to provide automatic troubleshooting during storage at the service center or warehouse 180.

[0075] In one embodiment, the service connector 50 includes a rechargeable battery 52 that is charged by the PD machine 20 when the PD machine is plugged into AC power. When the PD machine 20 is plugged into AC power, the service connector 50 is capable of actuating certain components within the PD machine 20 to troubleshoot it. For example, in one embodiment, the service connector 50 is capable of causing the control unit 30 of the PD machine 20 to actuate or switch the valves of the machine, such as pneumatic solenoid valves and / or electro-fluidic pinch valves, to ensure that these valves are actuated properly. The service connector 50 may also have the ability to cause the control unit 30 of the PD machine 20 to power on an air pump and monitor the associated pressure sensors to confirm that the target positive pneumatic drive pressure and the target negative pneumatic drive pressure are achievable.

[0076] The service connector 50 in the illustrated embodiment includes a control unit 60 that includes one or more processors 62, one or more memories 64, and a transceiver 66 for wireless communication with a service personal computer 182 and / or an intelligent device 184 located within the service center or warehouse 180. The control unit 60 of the service connector 50 may also include a Global Positioning System (“GPS”) tracker 68 that allows the PD machine 20 and the connected service connector 50 to be located at any time while within the service center or warehouse 180. Thus, the service connector 50 is capable of sending inquiries, diagnostics, component tests, PD machine 20 identification, and other relevant data to the service personal computer 182 and / or the intelligent device 184 to generate a work report and schedule further tests and diagnostics for that particular PD machine 20. A work order can be prepared for the PD machine based on its history that includes: parts that need to be repaired or replaced; further service analysis that needs to be performed; and / or current working parts that can be refurbished or replaced (as a preventive action) based on the PD machine's history. The service connector 50 enables the service process to start before the service personnel actually interrogate the PD machine 20, thereby allowing actions / repairs to be pre-identified and simplifying the service process.

[0077] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Accordingly, these changes and modifications are intended to be covered by the appended claims.

Claims

1. A peritoneal dialysis ("PD") system, comprising: A PD machine; And A docking station that is connected to the PD machine via a power line, the power line bringing power and optional data to the PD machine, wherein the docking station comprises: A plurality of connectors configured to receive cables of one or more wired peripheral entities, A transceiver for wireless communication with one or more wireless peripheral entities, and A power supply rated to power the PD machine during PD treatment, the PD treatment including batch or inline PD fluid heating.

2. The PD system according to claim 1, wherein The power line is the only physical connection between the PD machine and the docking station.

3. The PD system according to claim 1, the PD system being configured such that the PD machine is capable of connecting to a plurality of different versions or types of docking stations.

4. The PD system according to claim 1, the PD system including one or more wired and wireless peripheral devices, the wired and wireless peripheral devices including at least one medical monitor, the Internet, the internet, a smart device or a cellular phone.

5. The PD system according to claim 1, wherein, The PD machine and the docking station each comprise: a computer memory connector; a control unit of the PD machine, the control unit of the PD machine communicating with the PD machine computer memory connector; a control unit of the docking station, the control unit of the docking station communicating with the docking station computer memory connector, and wherein a storage stick is used to convey data between the control unit of the PD machine and the control unit of the docking station via the respective computer memory connectors.

6. The PD system according to claim 5, wherein The data includes PD treatment data from the PD machine and one or more PD treatment prescriptions from the docking station.

7. The PD system according to claim 6, wherein the PD system includes a clinician and / or a hospital system, and wherein, The docking station is configured to: (i) transmit PD treatment data to the clinician and / or hospital system, and (ii) receive the one or more PD treatment prescriptions from the clinician and / or hospital system.

8. The PD system according to claim 7, wherein, The docking station is communicatively coupled to the clinician and / or hospital system via at least one of the Internet or a data acquisition and analysis connectivity platform.

9. The PD system according to claim 1, wherein, The PD machine is configured to wirelessly communicate with the docking station to convey data between the PD machine and the docking station.

10. The PD system according to claim 9, wherein, The data includes PD treatment data from the PD machine and one or more PD treatment prescriptions from the docking station.

11. The PD system according to claim 10, wherein the PD system includes a clinician and / or a hospital system, and wherein, The docking station is configured to: (i) transmit PD treatment data to the clinician and / or hospital system, and (ii) receive the one or more PD treatment prescriptions from the clinician and / or hospital system.

12. The PD system according to claim 1, the PD system comprising a clinician and / or a hospital system, and wherein, The PD machine is configured to wirelessly communicate with the clinician and / or hospital system to convey data between the PD machine and the clinician and / or hospital system.

13. The PD system according to claim 12, wherein, The data includes PD treatment data from the PD machine and one or more PD treatment prescriptions from the clinician and / or hospital system.

14. The PD system according to claim 12, wherein, The PD machine is configured to wirelessly communicate with the clinician and / or hospital system via at least one of the Internet or a data acquisition and analysis connectivity platform.

15. The PD system according to claim 1 further includes an intelligent service connector configured to connect to the PD machine while waiting for service at a service center, and the intelligent service connector is configured to identify at least one action or repair required by the PD machine before starting the service.

16. The PD system according to claim 15, wherein, The intelligent service connector is configured to be inserted into a computer memory connector of the PD machine.

17. The PD system according to claim 15, wherein, The intelligent service connector is configured to actuate at least one component of the PD machine to test the at least one component.

18. The PD system according to claim 15, wherein The intelligent service connector includes a rechargeable battery configured to be recharged by the PD machine.

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