JP2021536632A - Medical fluid delivery system including mobile platform for patient involvement and treatment compliance - Google Patents

Abstract

A patient platform for patient involvement and treatment compliance is disclosed. In one example, a processor is configured to obtain medical information from a patient for involvement and treatment compliance tracking. To obtain medical information, the processor displays a user interface with fields where medical information should be populated. After receiving the selection of data fields, the processor offers the option to enter medical information from the image. When the option is selected, the processor receives the recorded image of the medical device or the screen of the medical device, extracts the text from the image, allows the selection of at least part of the text from the image, and is selected from the image. Write the text as medical information in the data field of the user interface. The processor transmits the medical information to the patient medical record stored in the clinician database.

Description

Engaging patients outside the medical environment for long periods of time is currently a virtually impossible task. As with becoming a gym member or buying a treadmill, many patients are typically bullish. For example, from the beginning, patients tend to take self-administered medical treatments (eg, medical fluid delivery treatments) at the patient's home without hesitation. With respect to treatment, patients need to connect themselves to a medical fluid delivery machine (or a container containing a renal failure treatment fluid) to cleanse their blood from the accumulation of toxins. Some of the treatments may include tasks that the patient needs to perform, such as weighing themselves, weighing their blood, and / or recording information related to their treatment. The information recorded by the patient is often scrutinized by the clinician to ensure that treatment is proceeding as prescribed. The clinician also reviews the recorded data to determine if treatment adjustment is needed.

Over time, many patients become less motivated to treat as they lose their novelty and become a mundane obligation. As you can imagine, patients will want to be more agitated, relaxed, or involved in stimulating activities compared to self-administered medical treatments. While the patient continues treatment, the patient sometimes begins to omit performing additional tasks associated with the treatment. Omitting additional tasks and becoming less motivated for treatment has the potential to create gaps in clinical supervision of ongoing treatment. As the patient becomes less involved in the treatment, the patient may begin to omit treatment or eliminate them altogether, endangering his or her health in the process.

Medical fluid data transfer systems, including mobile platforms, are disclosed herein. The medical fluid data transfer system is configured to improve patient involvement and / or treatment compliance through interactions provided through the patient's portable device (eg, cellular phone, smartphone, tablet computer, etc.). Specifically, the medical fluid data transfer system provides the patient with improved feedback and control (without feeling overwhelmed), which allows the patient, rather than the patient to follow the instructions from the clinician. Makes you feel like you are in control of your own treatment. For example, a personal mobile communication device of a medical fluid data transfer system may display treatment information and / or patient vital sign data. The personal mobile communication device may also allow the patient to switch between different prescribed treatments or programs without the need to directly program the medical fluid delivery machine. Patients who feel in control are more likely to remain involved in their treatment.

An exemplary medical fluid data transfer system also reduces the data aggregation burden on the patient by automating the process. For example, personal mobile communication devices allow patients to capture treatment or vital sign data for automatic transmission to a centralized clinician database. The patient may enter the data directly into a personal mobile communication device, receive the data electronically from a connected machine, or record the data using a camera. The data is transmitted within the medical fluid data transfer system to a database that stores the data in the patient medical records.

In addition, the exemplary medical fluid data transfer system provides the clinician with a gateway that allows the patient to communicate with the clinician in real time regarding any concerns or questions about the medical fluid delivery treatment. In some embodiments, the medical fluid data transfer system also provides patient access to educational or training materials. Accordingly, exemplary medical fluid data transfer systems are configured to connect patients to the assistance required or required to be involved in and / or remain compliant with treatment.

The medical fluid data transfer systems and methodologies of the present disclosure include, for example, plasma exchange, hemodialysis (“HD”), hemofiltration (“HF”), hemodiafiltration (“HDF”), and continuous renal replacement therapy (“HD”). CRRT ") Applicable for fluid delivery for treatment. The medical fluid data transfer systems described herein are also applicable to peritoneal dialysis (“PD”), intravenous drug delivery, and nutritional fluid delivery. These modalities can be referred to herein collectively or generally individually as medical fluid delivery or treatment.

The above modalities are one or more pumps, valves, heaters if needed, direct medical fluid generators if needed, pressure sensors, conductivity sensors, temperature sensors, air detectors, blood leak detection. A control unit or the like that may employ a sensor such as any one, two or more, or all of the instruments, a user interface, and one or more processors and memories for controlling the equipment described above. It may be provided by a medical fluid delivery machine that contains the components required to deliver the medical fluid. The medical fluid delivery machine also includes one or more filters such as a dialyzer or hemofilter for cleaning blood and / or an extrafilter for purifying water, dialysis fluid, or other fluid. obtain.

The medical fluid delivery machines and medical fluid data transfer systems and methodologies described herein can be used with home-based machines. For example, the system may be used with a home HD, HF, or HDF machine operated at the convenience of the patient. One such home-based system was published on October 4, 2011, entitled "High Connection Home Hemodialysis / Hemofiltration And Sonorbent System", filed on November 4, 2004, and transferred to the transferee of the present application. It is described in US Pat. No. 8,029,454 (“Patent No. '454”) issued. Another such home-based system was also issued on March 12, 2013, entitled "Enclosure for a Portable Hemodiarysis System", and was filed on August 27, 2008, US Pat. No. 8,393,690. ("Patent No. 690"). The entire contents of each of the above references are incorporated and relied upon herein by reference.

As detailed below, the medical fluid data transfer systems and methodologies of the present disclosure are equipped with many different types of devices, many machines, patients, clinicians, doctors, maintenance personnel, electronic medical records. (“EMR”) It may operate within a resource planning system that handles data generated via databases, websites, patient and clinician communications, and an inclusive platform system that may include business intelligence. The medical fluid data transfer systems and methodologies of the present disclosure operate seamlessly within the system without violating its rules and protocols.

The first of the present disclosure, which may be combined with any other aspect listed herein, in the light of the disclosure of the present specification and without limitation in any way, unless otherwise specified. In aspect of the machine-accessible device, when executed, the machine is configured to operate the camera, record images, operate the display interface, and connect to the clinician database. By operating the interface, the clinician database is configured to store patient medical records, and by operating the processor to obtain medical information, the patient medical records of the clinical system. Has instructions stored on it that are configured to populate the. The processor displays the user interface with the fields to which the medical information should be input via the display interface, and after selecting the data fields of the user interface, inputs the medical information from the image via the display interface. By providing a first option for graphically providing a second option for entering medical information via text input, it is made to operate to obtain medical information. When the first option is selected, the processor is to receive the image recorded from the camera, that the recorded image contains the medical device or the screen of the medical device, and that the text from the image. Extracting and allowing selection of at least a portion of the text from the image via the display interface and writing the selected text from the image to the data field of the user interface as medical information. When the second option is selected, the processor allows text entry of data fields as medical information via the display interface. The processor is also operated to obtain medical information by transmitting the medical information written in the data field to the patient medical record stored in the clinician database after the transmission instruction is received.

Unless otherwise stated, according to a second aspect of the disclosure that may be used in combination with any other aspect listed herein, a machine accessible device is imaged to the machine when performed. Determine the data template for the extracted text above and use the data template to process the extracted text, classify the extracted text into fields and allow at least one of the fields to be selected And further includes instructions stored on it that are configured to operate the processor to write selected text from the image to a data field in the user interface.

Unless otherwise stated, according to a third aspect of the disclosure that may be used in combination with any other aspect listed herein, the data template is extracted in relation to the text position in the image. It is configured to define the context for the text.

Unless otherwise stated, according to a fourth aspect of the present disclosure that may be used in combination with any other aspect listed herein, a machine-accessible device shall be machine-accessible when executed. i) Selection of medical device type via user interface, (ii) information scanned from an identifier located on the medical device, and (iii) at least one of the markers in the extracted text. Alternatively, (iv) further comprises instructions stored on it that are configured to operate the processor to determine a data template based on the relative arrangement of the extracted text.

Unless otherwise stated, according to a fifth aspect of the disclosure that may be used in combination with any other aspect listed herein, the identifier located on the medical device is the housing of the medical device. Includes at least one of a quick response (“QR”) code, barcode, serial number, or hardware number located on the screen of a body or medical device.

Unless otherwise stated, according to a sixth aspect of the disclosure that may be used in combination with any other aspect listed herein, the medical device is at least a renal failure therapy machine, infusion pump, oxygen sensor. , Respiratory monitor, glucose meter, blood pressure monitor, ECG monitor, weight scale, and heart rate monitor.

Unless otherwise stated, according to a seventh aspect of the disclosure that may be used in combination with any other aspect listed herein, the data fields of the user interface are blood pressure measurement data, pulse data, weight. It is configured to receive at least one of data, glucose data, temperature data, manual replacement data for renal failure, subjective data, or consumable data for a consumable item.

Unless otherwise stated, according to the eighth aspect of the present disclosure, which may be used in combination with any other aspect listed herein, consumable items include filters, blood line sets, dialysate concentrates. Includes at least one of a liquid container, a blood anticoagulant container, a drug container, a disposable cassette, an adsorbent cartridge, and a water purification container.

Unless otherwise stated, the machine is a personal mobile communication device according to a ninth aspect of the disclosure that may be used in combination with any other aspect listed herein.

Unless otherwise stated, according to a tenth aspect of the disclosure that may be used in combination with any other aspect listed herein, the recorded images are used to record patient medical records in a clinical database. The method of inputting data to the personal device is to use the camera of the personal device and transmit a first message prompting the patient to record the first image of the medical device, and from the personal device. Includes receiving a first image. The method is associated with determining the first medical information indicating the type or model of the medical device from the first image via the processor and the determined type or model of the medical device via the processor. A second message is sent to the personal device, which prompts the patient to determine the data template and the second message and to record the second image of the screen of the medical device using the camera via the processor. Also includes transmission. The method is to receive a second image from a personal device via a processor, extract text from the second image via a processor, and use a data template via a processor. It further includes processing the extracted text and classifying the extracted text into fields. The method further comprises writing at least a portion of the text from at least one of the fields into the patient medical record via a processor.

Unless otherwise stated, according to eleventh aspect of the present disclosure which may be used in combination with any other aspect listed herein, the method is via a processor, one of the fields and the patient. It further includes determining the correspondence with the recording field in the medical record and writing at least a portion of the text from the field to the recording field in the patient medical record via the processor.

Unless otherwise stated, according to a twelfth aspect of the present disclosure that may be used in combination with any other aspect listed herein, the method determines treatment time from patient medical records via a processor. Further comprising determining and transmitting a first message via the processor before the treatment time.

Unless otherwise stated, according to thirteenth aspect of the disclosure which may be used in combination with any other aspect listed herein, the method is in a processor, from a personal device, the patient initiates treatment. It further includes receiving a treatment message indicating that it should be, and transmitting a first message via the processor before the treatment is started.

Unless otherwise stated, according to the fourteenth aspect of the present disclosure which may be used in combination with any other aspect listed herein, the first image is a first text message or a first aspect. Received on the processor via a short messaging service (“SMS”) message, the second image is received on the processor via a second text message or a second SMS message.

Unless otherwise stated, according to the fifteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein, the method is via a processor, prior to writing to the patient medical record. It further comprises converting at least a portion of the text from at least one of the fields to a health level 7 (“HL7”) format.

Unless otherwise stated, according to the seventeenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein, the method is via a processor, at least one of the fields. A field that compares at least a portion of the text from Further includes writing at least a portion of the text from at least one of them.

Unless otherwise stated, according to the 17th aspect of the present disclosure, which may be used in combination with any other aspect listed herein, a system for transmitting information to a patient transmits therapeutic information. Identifies the patient's home therapy machine and medical records and the home therapy machine and the patient's personal device as registered devices, and installs an application for the personal device to view treatment information and medical information. Includes a registration file and a clinician database configured to store, identifying whether or not. The system also includes a clinician database, a home therapy machine, and a clinician server communicatively coupled to a personal device. The clinician server stores the treatment information and medical information in the medical record, receives the instruction that at least part of the treatment information and medical information should be displayed on the personal device, and from the registration file, the application It is configured to determine if it is installed on a personal device. If the application is installed, the clinician server will convert at least part of the treatment and medical information into an application format for display within the application and the converted treatment and medical information. It is configured to transmit at least part of it to a personal device. If the application is not installed, the clinician server will convert at least part of the treatment and medical information to a text message or short messaging service (“SMS”) format and one or more text or SMS messages. It is configured to transmit at least a converted portion of treatment information and medical information to a personal device via.

Unless otherwise stated, according to the eighteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein, the application format is an extended markup language ("XML") format or. Includes at least one of the Hypertext Markup Language ("HTML") formats.

Unless otherwise stated, according to the nineteenth aspect of the disclosure which may be used in combination with any other aspect listed herein, at least a portion of therapeutic and medical information is in a personal device. The instructions that should be displayed include at least one of a message from the application or a text / SMS message from a personal device.

Unless otherwise stated, according to a twentieth aspect of the disclosure that may be used in combination with any other aspect listed herein, the registration file is included in the medical record.

Unless otherwise stated, according to the 21st aspect of the present disclosure, which may be used in combination with any other aspect listed herein, the home therapy machine stores the prescription using two programs. Each of the programs is configured to provide parameters for operating the home therapy machine to perform treatment, and the clinician server indicates a program message indicating the change from the first program to the second program. Is configured to receive from the personal device and transmit a program instruction for changing from the first program to the second program to the home therapy machine.

In the 22nd aspect of the present disclosure, any of the structures and functionality disclosed in connection with FIG. 1-33 is any other structure and functionality disclosed in connection with FIG. 1-33. Can be combined with.

In light of the present disclosure and the aspects described above, it is therefore an advantage of the present disclosure to provide an improved medical fluid delivery system.

Providing an improved patient lifestyle is another advantage of the present disclosure.

It is a further advantage of the present disclosure to provide improved clinician or caregiver efficiency.

Providing improved mechanical efficiency is still another advantage of the present disclosure.

Providing improved patient compliance is still an additional benefit of this disclosure.

It is another advantage of the present disclosure to provide a medical fluid data transfer system and methodology that can be applied to different types of medical fluid delivery machines.

It is a further advantage of the present disclosure to provide a medical fluid data transfer system and methodology that allows communication between a medical fluid delivery machine and a patient and a clinician or a plurality of persons such as a patient and a primary caregiver. ..

Further, it is an advantage of the present disclosure to reduce the waste of disposable sets and other auxiliary textile products, which often occurs at the end of the mechanical timer, due to disposal.

The advantages discussed herein can be found in one or several of the embodiments disclosed herein, and perhaps not all of them. Additional features and advantages will be described herein and will become apparent from the embodiments and figures for carrying out the invention below.

FIG. 1 illustrates an embodiment of a medical fluid data transfer system that incorporates the medical fluid delivery machine of the present disclosure so that data can be transferred to and from such a machine according to an embodiment of the present disclosure. It is a schematic diagram.

FIG. 2 is a schematic diagram of an embodiment of the medical fluid delivery machine of the present disclosure.

FIG. 3 is a perspective view illustrating a blood set for use in combination with an embodiment of the medical fluid delivery machine of FIG. 2 according to an embodiment of the present disclosure.

FIG. 4 is a schematic diagram of an embodiment of the medical fluid delivery machine and data transfer system and method of the present disclosure.

FIG. 5 is a schematic diagram of a second embodiment of the medical fluid delivery machine and data transfer system and method of the present disclosure.

FIG. 6 is a schematic diagram of a third embodiment of the medical fluid delivery machine and data transfer system and method of the present disclosure.

FIG. 7 is a schematic representation of an embodiment of a hospital or clinical version of the medical fluid delivery device and data transfer system and method of the present disclosure having a mobile communication device application in a first state.

FIG. 8 is a schematic representation of an embodiment of a hospital or clinical version of the medical fluid delivery device and data transfer system and method of the present disclosure having a mobile communication device application in a second state.

FIG. 9 is a schematic representation of an embodiment of a hospital or clinical version of the medical fluid delivery device and data transfer system and method of the present disclosure having a mobile communication device application in a third state.

FIG. 10 shows a second embodiment of a medical fluid data transfer system.

FIG. 11 shows a schematic diagram illustrating an operating module of an application in the clinician server of the medical fluid data transfer system of FIG. 10 according to an embodiment of the present disclosure.

FIG. 12 shows a schematic diagram illustrating communication between the home therapy machine of FIGS. 10 and 11, a personal mobile communication device, and a clinician server, according to an exemplary embodiment of the present disclosure.

FIG. 13 illustrates an exemplary patient data structure stored on the clinician database of the medical fluid data transfer system of FIG. 10 according to an exemplary embodiment of the present disclosure.

14 and 15 show schematics illustrating the user interface of the application of FIG. 11 according to the exemplary embodiments of the present disclosure. 14 and 15 show schematics illustrating the user interface of the application of FIG. 11 according to the exemplary embodiments of the present disclosure.

FIG. 16 is a schematic diagram of the personal mobile communication devices of FIGS. 10 and 11 according to an exemplary embodiment of the present disclosure.

FIG. 17 illustrates a schematic diagram of a data template according to an exemplary embodiment of the present disclosure.

FIG. 18 shows a schematic diagram illustrating writing to the data fields of the user interface of FIG. 14 according to an exemplary embodiment of the present disclosure.

FIG. 19 is a flow diagram of an exemplary procedure for inputting medical information from an image using the application of the personal mobile communication device of FIGS. 10 and 11 according to an exemplary embodiment of the present disclosure.

FIG. 20 shows an example of a user interface viewable by an application on the personal mobile communication devices of FIGS. 10 and 11 that allows a patient to provide recorded images according to an exemplary embodiment of the present disclosure. ..

FIG. 21 shows a schematic diagram of a patient medical template used by the clinician server of FIGS. 10 and 11 to populate a data field of a patient's medical record according to an exemplary embodiment of the present disclosure.

FIG. 22 is a schematic diagram of the data acquisition module of the clinician server of FIG. 11 according to an exemplary embodiment of the present disclosure.

23 and 24 are the medical devices of FIG. 21 using images (and / or text messages received from them) recorded by the personal mobile communication devices of FIGS. 10 and 11 according to certain exemplary embodiments of the present disclosure. It is a flow diagram of an exemplary procedure for inputting data into a template. 23 and 24 are the medical devices of FIG. 21 using images (and / or text messages received from them) recorded by the personal mobile communication devices of FIGS. 10 and 11 according to certain exemplary embodiments of the present disclosure. It is a flow diagram of an exemplary procedure for inputting data into a template.

FIG. 25 is a schematic representation of a clinician server hosting a website or file transfer site for receiving medical information via images from the personal mobile communication devices of FIGS. 10 and 11, according to an exemplary embodiment of the present disclosure. Is shown.

26-29 show a schematic of a personal mobile communication device displaying medical information provided by the clinician server of FIGS. 10 and 11 according to an exemplary embodiment of the present disclosure. 26-29 show a schematic of a personal mobile communication device displaying medical information provided by the clinician server of FIGS. 10 and 11 according to an exemplary embodiment of the present disclosure. 26-29 show a schematic of a personal mobile communication device displaying medical information provided by the clinician server of FIGS. 10 and 11 according to an exemplary embodiment of the present disclosure. 26-29 show a schematic of a personal mobile communication device displaying medical information provided by the clinician server of FIGS. 10 and 11 according to an exemplary embodiment of the present disclosure.

FIG. 30 shows a schematic representation of the personal mobile communication device of FIGS. 10 and 11 that prompts a patient for medical information according to an exemplary embodiment of the present disclosure.

FIG. 31 shows a schematic representation of the personal mobile communication devices of FIGS. 10 and 11 that provide a program for medical treatment to be selected by a patient according to an exemplary embodiment of the present disclosure.

FIG. 32 shows a schematic representation of the personal mobile communication devices of FIGS. 10 and 11 that provide educational content to a patient according to an exemplary embodiment of the present disclosure.

FIG. 33 shows a schematic representation of the personal mobile communication devices of FIGS. 10 and 11 that provide a video chat session between a patient and a clinician according to an exemplary embodiment of the present disclosure.

The medical fluid delivery system is disclosed herein. An exemplary medical fluid delivery system is configured to improve patient involvement with medical treatments such as medical fluid delivery treatments. The medical fluid delivery system provides patients with additional transparency about their treatment and at least some control to direct their treatment, while providing resources to educate or otherwise assist the patient throughout the treatment process. Configured to provide. An exemplary medical fluid delivery system is configured to provide patient involvement regardless of the type or set of features of the medical device or patient's personal mobile communication device associated with the treatment. Such a configuration allows the disclosed medical fluid delivery system to be adapted to virtually any patient situation.

In some embodiments, the medical fluid delivery system includes a personal mobile communication device, a medical fluid delivery machine, and a clinician server / database. Exemplary personal mobile communication devices and medical fluid delivery machines are located at the patient's home and / or at a self-service medical facility. The clinician server is communicably coupled to a personal mobile communication device and / or a medical fluid delivery machine via a wide area network (ie, the Internet). The clinician server is configured as a hub, which allows personal mobile communication devices to provide features designed to engage patients with medical fluid delivery therapies.

As disclosed herein, an exemplary clinician server receives medical fluid delivery data (eg, treatment information) from a medical fluid delivery machine, and the delivery data is one or more patients in the clinician database. It is stored in the record. The clinician server provides personal mobile communication devices with access to medical fluid delivery data, allowing patients to track treatment progress. In addition, the patient may use a personal mobile communication device to change (or request to change) the treatment program. Requests are routed through the clinician server to verify that the changes are appropriate before being transmitted to the medical fluid delivery machine.

An exemplary clinician server operates in connection with a personal mobile communication device to allow a patient to provide medical information such as vital sign data, medical device data, etc. effortlessly. Personal mobile communication devices allow patients to manually enter data, record photos containing data from connected medical devices such as weigh scales, blood pressure monitors, thermometers, glucose meters, and / or data from it. It is configured to allow radio reception. The collected data is stored in the patient's medical record. In some embodiments, the clinician server and / or personal mobile communication device may use the template to determine how the received data should be automatically populated into the patient's medical record.

As disclosed herein, personal mobile communication devices may include feature-rich smart devices such as smartphones or tablet computers. A smart device may run a specialized application (eg, an "app") defined by an instruction stored in memory. Execution of the stored instructions drives the application into the process of the smart device, and the application is configured to improve the patient's involvement in medical treatment. In some cases, personal mobile communication devices may include conventional cellular phones with less features, including significantly less processing power and features compared to smart devices. Cellular devices may operate using specialized applications (eg, apps) defined by text messages and / or instructions stored in memory. An application for a low feature device may have fewer features compared to an application for a smart device.

The following disclosure is divided into two sections. The first section discloses an embodiment of a medical fluid delivery system. The second section discloses features that enable a medical fluid delivery system to improve patient involvement and / or compliance with medical treatment.

(I. Medical fluid delivery system embodiment)
An exemplary medical fluid delivery system includes one or more medical fluid delivery machines. An example of a medical fluid delivery machine is a renal failure treatment machine. With respect to the renal failure treatment machine, the patient's renal system is unable to function due to various causes. Renal failure causes some physiological disturbances. It is no longer possible to balance water and minerals, or to excrete daily metabolic loads. Toxic final products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in blood and tissues.

Renal failure and diminished renal function have been treated with dialysis. Dialysis removes from the body waste products, toxins, and excess water that a normally functioning kidney would otherwise remove. Dialysis treatment for the replacement of renal function is important for many people because the treatment is life-saving.

One type of treatment for renal failure is hemodialysis (“HD”), which commonly uses diffusion to remove waste products from the patient's blood. A diffusion gradient occurs across the semi-permeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to cause diffusion.

Hemofiltration (“HF”) is an alternative renal replacement therapy that relies on convective transport of toxins from the patient's blood. HF is accomplished during treatment by adding an alternative or replacement fluid (typically 10-90 liters of such fluid) to the extracorporeal circuit. The fluid accumulated by the patient between the replacement fluid and the treatment is ultrafiltered throughout the course of HF treatment to provide a convection transport mechanism that is particularly beneficial in removing medium and large molecules (in hemodialysis). A small amount of waste is removed along with the fluid obtained during the dialysis session, however, solute withdrawal from the removal of its extraneous filtrate is not sufficient to provide convection clearance).

Hemodiafiltration (“HDF”) is a therapeutic modality that combines convection and diffusion clearance. HDF uses a dialysis fluid that flows through a dialyzer, similar to standard hemodialysis, to provide diffusion clearance. In addition, an alternative solution is provided directly to the extracorporeal circuit to provide convection clearance.

Most HD (HF, HDF) treatments are performed at the center. The tendency towards home hemodialysis (“HHD”) is that, in part, HHD can be performed daily, with therapeutic benefits over in-center hemodialysis treatment (typically performed two or three times a week). As it offers, it exists today. Studies have shown that frequent treatments remove more toxins and waste products than patients who receive less frequent but probably longer treatments. Patients who receive treatment more frequently do not suffer as many downcycles as in-center patients who have accumulated a few days' worth of toxin prior to treatment. In some areas, the nearest dialysis center can be miles away from the patient's home, which causes door-to-door treatment time, which spends most of the day. HHD can occur overnight or during the day while the patient is relaxed, working, or otherwise productive.

Another type of treatment for renal failure is peritoneal dialysis, which injects dialysate, also called dialysis fluid, into the patient's peritoneal cavity through a catheter. The dialysis fluid contacts the peritoneum of the peritoneal cavity. Waste products, toxins, and excess water flow from the patient's bloodstream, through the peritoneum, into the dialysis fluid, due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. Penetrants in dialysis provide an osmotic gradient. The used or depleted dialysis fluid is drained from the patient and removes waste products, toxins, and excess water from the patient. This cycle is repeated, for example, multiple times.

There are various types of peritoneal dialysis treatment, including continuous outpatient peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), and tidal current dialysis, and continuous fluid peritoneal dialysis (“CFPD”). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to the drain to allow the used or depleted dialysate fluid to drain from the peritoneal cavity. The patient then connects the catheter 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 fresh dialysis fluid bag, allowing the dialysis fluid to retain in the peritoneal cavity, resulting in the transfer of waste products, toxins, and excess water. After a retention period, the patient repeats the manual dialysis procedure, for example, four times a day, with each treatment lasting about one hour. Manual peritoneal dialysis requires a considerable amount of time and effort from the patient and has room for improvement.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that dialysis treatment involves drainage, filling, and retention cycles. However, APD machines typically perform cycles automatically while the patient is asleep. The APD machine relieves the patient from the need to perform the treatment cycle manually and from the need to carry supplies during the day. The APD machine fluidly connects to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. The APD machine pumps fresh dialysis fluid from the dialysis fluid source through a catheter into the patient's peritoneal cavity. The APD machine also allows the dialysis fluid to stay in the cavity, allowing the transfer of waste, toxins, and excess water to occur. The source may include multiple sterile dialysis fluid bags.

The APD machine pumps used or depleted dialysate from the peritoneal cavity through a catheter to the drain. Like the manual process, some drainage, filling, and retention cycles occur during dialysis. The "final filling" occurs at the end of the APD and remains in the patient's peritoneal cavity until the next treatment.

Any of the above modalities implemented by the machine can be performed on a schedule basis and require a startup procedure. For example, dialysis patients typically receive treatment on a schedule basis, such as every other day or every day. Blood treatment machines typically require a certain amount of time prior to treatment, for example, for a setting to perform a disinfection procedure. Patients with the above modality may lead a busy life and have plans or errands to be performed on a scheduled day of treatment.

Much of the appeal of home care for patients revolves around the lifestyle flexibility provided primarily by allowing patients to perform treatment at home according to their own schedule. However, the home medical fluid delivery machine may include a software timer that directs and constrains the user or patient. The home hemodialysis system may require the patient to be in close proximity to the home hemodialysis machine, for example, to initiate pre-treatment, in-treatment, and post-treatment sequences.

In one particular example, home care machines may reuse certain components by disinfecting them between treatments. The machine may employ one or more disinfection timers, which require the patient or caregiver to initiate treatment using the machine before the disinfection timer ends. Otherwise, the patient will have to wait until another disinfection procedure is completed before starting treatment. A home treatment machine in one embodiment communicates a treatment start time deadline via the machine's graphical user interface, which allows the patient to be near the machine to access and respond accordingly. Request that.

It should be understood that this disclosure applies to any type of disinfection such as hot water disinfection and chemical disinfection. In this regard, the disclosure is not limited to home care machines, for example, in-center machines may typically be chemically disinfected, and in-center machines may set a treatment start deadline after such disinfection. .. Furthermore, the present disclosure is not limited to start time deadlines based on disinfection, but may also apply to other start time deadlines, such as those based on the completion of priming. Furthermore, the disclosure is not limited to the initial start time deadline. For example, most machines will allow the patient to temporarily discontinue treatment, disconnect from the machine, and perform certain types of necessary actions away from the machine. For blood treatment, the machine typically rinses the blood back to the patient and may or may not circulate the dialysis fluid over a period of time. In either case, the time a patient may be temporarily disconnected from the machine is not unlimited, and it is expected that the disclosure also applies to the return time limit.

In one embodiment, the system of the present disclosure provides a software application (“app”) installed on a patient and / or caregiver's personal mobile communication device, eg, a smartphone. The application, in one embodiment, is provided via a middleware software application, an example of which is discussed in detail below. In an alternative embodiment, the software is configured to use text messaging features directly through a middleware software application to communicate with a patient and / or caregiver's personal mobile communication device, such as a smartphone. In either case, the app or text message, in one embodiment, requires the patient and / or caregiver to initiate treatment, reminding the patient of any imminent deadline without connecting the patient to the machine. It is built to be able to track a certain time.

As an alternative, or in addition, it is envisioned to build communication software to automatically program reminders on the user's mobile communication device, eg, on the device's unique task tracking features such as calendar applications. Most smartphones are offered a calendar that separates each day into time segments such as time. The system and methodology software of the present disclosure accesses the licensed patient and / or caregiver's smartphone calendar and disinfects the appropriate information in the appropriate time segment of the appropriate day, eg, the machine within that time segment. It can be programmed to inject to start or complete.

In one embodiment, communication from the software systems and methodologies of the present disclosure is unidirectional. For example, the communication can be that of a medical fluid delivery machine, which can be a home machine, to a patient or caregiver's mobile communication device. In an alternative embodiment, the software systems and methodologies of the present disclosure enable two-way communication between a medical fluid delivery machine and a patient or caregiver mobile communication device. In one example, two-way communication may allow a machine routine to be remotely initiated by a patient or caregiver using those mobile communication devices. An exemplary routine is an automated self-test routine, which can be performed without any user interaction with the system other than initiating or initiating a sequence. Initiating the sequence remotely can benefit the patient or caregiver, for example, by providing additional time for the patient or caregiver to leave the machine to perform other tasks. Communication is bidirectional when the machine initiates communication by indicating that the machine is ready to perform a self-test routine. The patient or caregiver responds to the machine via the software system and methodology of the present disclosure at the desired time and initiates the sequence.

Whenever the machine is in the "patient connection" software state, it is assumed that the system and methodology software of the present disclosure disables communication between the patient and / or the caregiver and the machine. For example, if a clinician attempts to send a command to a machine that is currently treating a patient, the command may be blocked by a middleware software application so that the command is not transferred to that machine. The middleware software application can then reply to the clinician informing him that the machine is busy and will not accept communications.

The examples described herein are applicable to any medical fluid delivery system that delivers medical fluids such as blood, dialysis fluids, alternative fluids, and / or intravenous drugs (“IV”). Examples are, in particular, all forms of hemodialysis (“HD”), hemofiltration (“HF”), hemodiafiltration (“HF”), collectively or generally individually referred to herein as treatment for renal failure. It is highly suitable for the treatment of renal failure such as "HDF"), continuous renal replacement therapy ("CRRT"), and peritoneal dialysis ("PD"). The medical fluid delivery machine may be an alternative drug or nutrient fluid delivery device such as a mass perturbation type pump or syringe pump. The machines described herein can be used in home settings. For example, a machine operating in the data transfer mode of the present disclosure may be employed, for example, with a home HD machine that may be activated at night while the patient is sleeping. The medical fluid data transfer systems and methodologies of the present disclosure may be used as an alternative to assist clinicians or nurses in hospitals and / or clinics.

Here, with reference to the drawings, in particular FIG. 1, the medical fluid data transfer system 10 operating within the medical fluid delivery machine 90 is illustrated. The system 10 incorporates many medical fluid delivery machines 90, one of which is discussed in detail below. The machine 90 of the data transfer system 10 can be of the same type (eg, all HD machines) or of a different type (eg, a mixture of HD, PD, CRRT, and medical or nutritional fluid delivery).

Although a single medical fluid delivery 90 is illustrated as communicating with a connection server 118, the system 10 oversees the operation of multiple medical fluid delivery systems and machines of the same type or of different types listed above. do. For example, M number of hemodialysis machines 90, N number of hemofiltration machines 90, O number of CRRT machines 90, P number of peritoneal dialysis machines connected to the server 118 and operating together with the system 10. There may be 90, Q home drug delivery machines 90, and R number nutrition or drug delivery machines 90. The numbers from M to R can be the same or different numbers, and can be zero, one, or two or more. In FIG. 1, the medical fluid delivery machine 90 is illustrated as a home care machine 90 (home is indicated by a dashed line).

The home treatment machine 90 may receive purified water from the water treatment device 60 as discussed above at its front end. In certain embodiments, the water treatment device 60 connects to the home care machine 90 via an Ethernet® cable. The home care machine 90 in the illustrated embodiment operates with a device other than the water treatment device 60, such as a blood pressure monitor 104, a measuring instrument, eg, a wireless measuring instrument 106, and a user interface such as a wireless tablet user interface 122. .. In one embodiment, the home treatment machine 90 wirelessly connects to the server 118 via the modem 102. Each of these components may (but not necessarily) be located within the patient's home as defined by the dashed line in FIG. Any one, two or more, or all of the components 60, 104, 106, and 122 may communicate with the home care machine 90 by wire or wirelessly. Wireless communication is Bluetooth®, WiFi®, Zigbee®, Z-Wave®, wireless universal serial bus (“USB”), infrared, or any other suitable radio. It can be through communication technology. Alternatively, any one, two or more, or all of the components 60, 104, 106, and 122 may communicate with the home care machine 90 via wired communication.

The connection server 118 communicates with the medical fluid delivery machine 90 via the medical device system hub 120. The system hub 120 allows data and information about each home treatment machine 90 and its peripherals to travel between the machine 90 and other clients connected to the server 118 via the connection server 118. In the illustrated embodiment, the system hub 120 includes a service portal 130, a corporate resource planning system 140, a web portal 150, a business intelligence portal 160, a HIPAA compliant database 124, a product development team 128, and, for example, a clinic or hospital 126a. Connected to an electronic medical record database maintained at -126n.

An electronic medical record (“EMR”) database at a clinic or hospital 126a-126n stores electronic information about a patient. The system hub 120 may transmit the data collected from the log file of the machine 90 to the hospital or clinic database 126a-126n to merge or supplement the medical records of the patient. Databases in clinics or hospitals 126a-126n may contain patient-specific treatment and prescribing data, and therefore access to such databases may be highly restricted. The enterprise resource planning system 140 acquires and compiles data generated via patient and clinician website access such as complaints, billing information, and lifecycle management information. The web portal 150 allows patients and clinics 152a-152n treating patients to access publicly available websites for users of the medical fluid delivery machine 90. The Business Intelligence Portal 160 collects data from the System Hub 120 and provides the data to Marketing 162, Research and Development 164, and Quality / Pharmacovigilance Monitoring 166.

It should be appreciated that the systems, methods, and procedures described herein can be implemented using one or more computer programs or components. The component program can be read by any conventional computer, including random access memory (“RAM”), read-only memory (“ROM”), flash memory, magnetic or optical disk, optical memory, or other storage medium. It can be provided as a series of computer instructions on the medium. Instructions may be configured to be executed by a processor that, upon executing a series of computer instructions, implements all or part of the disclosed methods and procedures, or facilitates their implementation.

In one embodiment, the home care machine 90 performs home treatment, such as home hemodialysis, to the patient at the patient's home, and then the clinician, doctor, and nurse involved in managing the health and welfare of the patient. Report the result of the treatment to the teacher.

The home care machine 90 in one embodiment uses, for example, the Linux® operating system to write log files. The log file documents the data of the relevant home care machine 90, including peripheral device data. The log file may contain one or more of an extended markup language (“XML”), a comma separated value (“CSV”), or a text file. The log file is installed in the file server box of the software of the home treatment machine 90. It is also envisioned that data that is not transmitted to the machine 90 is stored in a peripheral device, such as the water treatment device 60. Such data may be acquired separately via a wired or wireless connection to peripheral devices, or may be downloaded through other data connections or storage media. For example, maintenance personnel can access additional data via a laptop connected to the water treatment device 60 or the wireless scale 106, for example, via an Ethernet® connection. Alternatively, additional data can be read remotely from the peripheral device, and the home care machine 90 serves as a data transfer communication path between the peripheral device and an authorized client of the medical fluid data transfer system.

In one embodiment, the home care machine 90 uses a connection service, for example, via the Internet to transfer data between the modem 102 and the system hub 120. Here, a dedicated line may be provided at each patient's home to connect the home care machine 90 to the connection server 118 via the modem 102. The home care machine 90 in one embodiment uses a separate, eg, 3G, 4G, or 5G modem 102 to access the Internet. Modem 102 may use an Internet Service Provider (ISP) such as Vodafone®. In one implementation, a connection agent 114 developed by a connection service provider (eg, a provider of connection server 118) is installed on the home care machine 90 and launched on the machine's ACPU50. One suitable connection service is provided by Axeda®, which provides a securely managed connection 116 between a medical device and a connection server 118.

The connection agent 114 allows the home care machine 90 to connect to the connection server 118 and transfer data to and from the connection server 118. The connection service operating through the agent 114 and the server 118 ensures that the connection with the machine 90 is secure, that the data passes through the firewall of the machine 90 correctly, and that there is a data or system crash. Check to see if the connection server 118 is communicating with the correct home care machine 90.

In one embodiment, the home care machine 90 may connect to the connection server 118 only when the connection agent 114 is turned on or activated. During treatment and post-treatment disinfection, while Machine 90 and its peripherals are functioning, in one embodiment, the connection agent 114 is turned off, which is during treatment and disinfection, or when Machine 90 is activated or activated. When present, it prevents the home care machine 90 from communicating with any entity and transmitting or receiving data. When the home treatment machine 90 is idle, for example after treatment and post-disinfection are complete, the ACPU 50, in one embodiment, turns on the connection agent 114. In certain embodiments, the connection agent 114 is off during treatment and possibly pretreatment. After the treatment, the connection agent 114 uses the connection service to read the log file from the home treatment machine 90 and transfer the data to the connection server 118. Connection services route data packets to their appropriate destinations, but in one embodiment do not modify, access, or encrypt the data.

In the medical fluid data transfer system 10 of FIG. 1, the connection service via the connection server 118 is sent to various locations such as the service portal 130, the clinic or hospital 126a-126n, and the web portal 150 via the system hub 120. Data can be communicated. The connection server 118 allows maintenance personnel 132a-132n and / or the clinician to perform various assets across the network (such as the appropriate home care machines 90 and 3G, 4G, or 5G modem 102) and their associated information (machines). Or it allows you to track and read (including modem serial numbers). The connection server 118 receives a firmware upgrade approved by the maintenance personnel supervisor 134 and obtained remotely via the service portal 130 and is associated with the authorized home care machine 90 and water treatment device 60 and the like. It can also be used to provide peripherals.

(A. Exemplary medical fluid delivery machine)
Here, with reference to FIG. 2, an example of an HD flow schematic for the medical fluid delivery machine 90 is illustrated. Since the HD system of FIG. 2 is relatively complex, FIG. 2 and its discussion are also for any of the renal failure treatment modality discussed above and for IV, drug delivery, or nutrient fluid delivery machines. Provide support. Generally, a medical fluid delivery machine 90 with a simplified version of a dialysis fluid or process fluid delivery circuit is shown. The blood circuit is also simplified, but not so much as the dialysis fluid circuit. The circuits have been simplified to facilitate the description of the present disclosure, and the system, if implemented, has additional structure and functionality, such as those found in publications incorporated by reference above. Please understand that you will have.

The medical fluid delivery machine 90 of FIG. 2 includes a blood circuit 20. The blood circuit 20 draws blood from patient 12 and returns blood to it. Blood is drawn from the patient 12 via the arterial line 14 and returned to the patient via the venous line 16. The arterial line 14 includes an arterial line connector 14a, the arterial line connector 14a connects to the arterial needle 14b, and the arterial needle 14b communicates with the patient 12 for blood sampling. The venous line 16 includes a venous line connector 16a, the venous line connector 16a is connected to the venous needle 16b, and the venous needle 16b communicates with the patient for blood return. Arterial and venous lines 14 and 16 include line clamps 18a and 18v which can be spring loaded fail-safe mechanical pinch clamps. The line clamps 18a and 18v, in one embodiment, are automatically closed in an emergency situation.

Arterial and venous lines 14 and 16 also include air or bubble detectors 22a and 22v, which can be ultrasonic air detectors, respectively. The air or bubble detectors 22a and 22v detect air in arterial and venous lines 14 and 16, respectively. If air is detected by one of the air detectors 22a and 22v, the system 10 closes the line clamps 18a and 18v, suspending the blood and dialysis fluid pumps so that treatment can be resumed. Instruct the patient to clear the air.

The blood pump 30 is located within the arterial line 14 in the illustrated embodiment. In the illustrated embodiment, the blood pump 30 includes a first blood pump pod 30a and a second blood pump pod 30b. The blood pump pod 30a operates with the inlet valve 32i and the outlet valve 32o. The blood pump pod 30b operates with the inlet valve 34i and the outlet valve 34o. In certain embodiments, each of the blood pump pods 30a and 30b is a blood vessel, which comprises, for example, a spherical hard outer shell with a flexible diaphragm located within the shell to form a diaphragm pump. One side of each diaphragm receives blood, while the other side of each diaphragm is operated by positive and negative pneumatics. The blood pump 30 is, as an alternative, a peristaltic pump that works with the arterial line 14 or a plurality of peristaltic pumps that work with the arterial line 14 and the venous line 16.

The heparin vial 24 and the heparin pump 26 are located between the blood pump 30 and the hemofilter 40 (eg, a dialyzer) in the illustrated embodiment. The heparin pump 26 can be a pneumatic pump or a syringe pump (eg, a stepper motor driven syringe pump). Supplying heparin upstream of the hemofilter 40 helps prevent coagulation of the filter membrane.

The primary control processor (“ACPU”) or control unit 50 includes one or more processors and memory. The control unit 50 receives air detection signals from the air detectors 22a and 22v (and other sensors in the system 10 such as temperature sensors, blood leak detectors, conductivity sensors, pressure sensors, and access disconnect transducers 86, 88). It controls components such as line clamps 18a and 18v, blood pumps 30, heparin pumps 26, dialysis fluid pumps 64 and 96, and valves 32i, 32o, 34i, 34o, 68i, 68o, 98i, and 98o. Blood exiting the hemofilter 40 through the venous line 16 flows through the air trap 28. The air trap 28 removes air from the blood before the dialyzed blood is returned to the patient 12 via the venous line 16.

In the hemodialysis version of the medical fluid delivery machine 90 of FIG. 2, the dialysis fluid is pumped along the outside of the hemofilter 40 membrane, while the blood is pumped through the inside of the hemofilter membrane. The dialysis fluid is prepared starting with water purification via the water purification unit 60. One suitable water purification unit, entitled "Water Purification System and Method", is filed April 25, 2011, US Patent Publication No. 2011/019771, the entire contents of which are herein by reference. Incorporated and relied on in the book). In one embodiment, the water purification unit has water less than 0.03 endotoxin units / ml (“EU / ml”) and 0.1 colony forming units / ml (“CFU / ml”) in one implementation. Includes a filter and other structures for purifying tap water (eg, removing ions such as pathogens and chlorine) to be below. In the water purification unit 60, the hemodialysis machine 90 may be provided in a housing separate from the housing or chassis of the hemodialysis machine 90 including the blood circuit 20 and the dialysis fluid circuit 70.

The dialysis fluid circuit 70 is again greatly simplified in FIG. 2 for ease of illustration. The dialysis fluid circuit 70 in practice may include all of the relevant structures and functionality described in the publication incorporated by reference above. A feature of the dialysis fluid circuit 70 is illustrated in FIG. In the illustrated embodiment, the dialysis fluid circuit 70 includes a dialysis fluid pump 64 bound for a hemofilter. The pump 64, in one embodiment, is configured the same as the blood pump 30. The pump 64, like the pump 30, includes a pair of pump pods 66, each having an inlet valve 68i and an outlet valve 68o, which may again be configured spherically. The two pump pods are operated alternately, as with respect to the blood pump 30, whereby one pump pod fills with the HD dialysis fluid while the other pump pod discharges the HD dialysis fluid.

The pump 64 is a dialysis fluid pump bound for a hemofilter. There is another dual pod pump chamber 96 that works with valves 98i and 98o located at drain line 82 to push to drain the used dialysis fluid. There is a third pod pump (not shown) for pumping purified water through the bicarbonate cartridge 72. There is a fourth pod pump (not shown) used to pump the acid from the acid vessel 74 into the mixing line 62. The third and fourth pumps, i.e., concentrate pumps, in one embodiment, are due to a buffered dialysis fluid tank (not shown) between the mixing line 62 and the dialysis fluid pump 64 to the hemofilter. It can be a single pod pump as continuous pumping is less important in the mixing line 62.

A fifth pod pump (not shown) provided at drain line 82 is used to remove a known amount of extrafiltration (“UF”) when HD treatment is provided. The system 10 tracks the UF pump to control and understand the amount of extrafiltration fluid removed from the patient. System 10 ensures that the required amount of extrafiltration fluid is removed from the patient by the end of treatment.

Each of the pumps described above may, as an alternative, be a peristaltic pump operating with a pump tube. Where applicable, system valves can still be pneumatically operated in accordance with the features of the present disclosure.

In one embodiment, the purified water from the water purification unit 60 is pumped along the mixing line 62 through the bicarbonate cartridge 72. The acid from the vessel 74 is pumped along the mixing line 62 into the bicarbonate water flowing from the bicarbonate cartridge 72 to form an electrolytically and physiologically compatible dialysis fluid solution. Pumps and temperature-compensated conductivity sensors used to properly mix purified water with bicarbonate and acid are not shown, but are disclosed in detail in publications incorporated by reference above.

FIG. 2 shows that before the dialysis fluid reaches the hemofilter 40, it is pumped along the fresh dialysis fluid line 76 through the heater 78 and the outfiltration filter 80, after which the used dialysis fluid is pumped through the drain line 82. It is also illustrated that the fluid is pumped so that it is discharged. The heater 78 heats the dialysis fluid to body temperature or about 37 ° C. The ultrafiltrationr 80 further cleans and purifies the dialysis fluid before reaching the hemofilter 40, and foreign matter and / / introduced from the dialysis fluid via, for example, a bicarbonate cartridge 72 or an acid container 74. Or filter the contaminants.

The dialysis fluid circuit 70 also includes a sample port 84 in the illustrated embodiment. The dialysis fluid circuit 70 is a blood leak detector (not shown, but used to detect if the fibers of the hemofilter 40 are torn) and publications all incorporated by reference above. Will further include equilibrium chambers, multiple dialysis fluid valves, and other components not shown, such as dialysis fluid holding tanks, which are illustrated and described in detail in.

In the illustrated embodiment, the medical fluid delivery machine 90 is a continuous series of work passage systems in which the dialysis fluid is pumped once through a hemofilter and then the used dialysis fluid is drained. Pump to do. Both the blood circuit 20 and the dialysis fluid circuit 70 can be disinfected with warm water after each treatment so that the blood circuit 20 and the dialysis fluid circuit 70 can be reused. In one implementation, the blood circuit 20 including the hemofilter 40 is hot water sterilized and reused daily for about 1 month, while the dialysis fluid circuit 70 is hot water sterilized and reused for about 6 months.

In an alternative embodiment, for example with respect to CRRT, multiple bags of sterile dialysis fluid or injectable solution are grouped together and used one after the other. In such cases, the empty supply bag can serve as a drained or depleted fluid bag.

The medical fluid delivery machine 90 includes inclusion bodies as shown by the dashed line in FIG. The inclusion body of the machine 90 is the type of treatment, whether the treatment is in-center or home-based, and whether the dialysis fluid / injectable supply is batch type (eg, bagged) or directly connected. It fluctuates accordingly.

FIG. 3 illustrates that the machine 90 of FIG. 2 can operate with the blood set 100. The blood set 100 includes an arterial line 14, a venous line 16, a heparin vial 24, a heparin pump 26 / blood pump 30, and a hemofilter 40 (eg, a dialyzer). The air trap 28 may be located at the venous line 16 to remove air from the blood before being returned to patient 12. Air detectors 22a and 22v contact arterial and venous lines 14 and 16, respectively for operation.

In FIGS. 2 and 3, any one of pumps 26, 30 (30a and 30b), 64, 96 (and other pumps not shown) and valves 32i, 32o, 34i, 34o, 68i, 68o, 98i, and 98o. Any of these valves can be pneumatically operated. In certain embodiments, each of the pump and valve has a fluid side and an air side separated by a flexible membrane. Negative air pressure can be applied to the air side of the membrane to draw the fluid into the pump chamber or to open the valve (or the pump or valve releases positive closing pressure to the atmosphere and the fluid It can be released by allowing the pressure to be released). Positive air pressure is applied to the air side of the membrane to expel fluid from the pump chamber or to close the valve.

(B. Connectivity Embodiment of an exemplary medical fluid delivery system)
Here, with reference to FIG. 4, the system 110a of the present disclosure is illustrated. The system 110a in the illustrated embodiment operates with the system 10 described above, wherein the system 10 includes a connection server 118, a system hub 120, a service portal 130, a corporate resource planning system 140, a web portal 150, and business intelligence. Includes portals 160, which are illustrated in FIG. 4 as part of the cloud environment. Connection Server 118, System Hub 120, Service Portal 130, Corporate Resource Planning System 140, Web Portal 150, and Business Intelligence Portal 160 are each part of a cloud environment or located on one or more dedicated servers. Can be.

Other components of system 10 not shown in FIG. 4 may also be part of system 110a. For example, the medical fluid delivery machines 90a and 90b may be separately present in the home of patients 12a and 12b (illustrated as being outside the home). Alternatively, the medical fluid delivery machines 90a and 90b may be present within the same clinic 126a-126n, or within different clinics 126a-126n. The clinicians 112a and 112b may be in or out of the clinic.

The medical fluid delivery machines 90a and 90b are connected to the connection server 118 via a securely managed connection 116 as described above. To do so, the machines 90a and 90b connect to the internet 52, for example, via the modem 102 discussed above. The system hub 120 in one embodiment provides middleware software that can be accessed by mobile communication devices 200a and 200b (collectively referred to herein as device 200, or generally individually referred to as device 200). Remember. Mobile communication devices 200a and 200b are, for example, Android (registered trademark), iOS (registered trademark), Windows (registered trademark) Phone (registered trademark), BlackBerry (registered trademark), Sailfish OS (registered trademark), Tizen (registered trademark). ), Or a smartphone booted on the Ubuntu Touch® operating system. The mobile communication devices 200a and 200b may belong to patients 12a and 12b, respectively, and / or clinicians 112a and 112b, respectively. Mobile communication devices 200a and 200b as shown in FIG. 4 are also connected to the Internet 52.

In one embodiment, the mobile communication devices 200a and 200b download application software (“apps”) from middleware software stored on the system hub 120 via their connection to the Internet 52. The app is updated whenever there is a change in the state of the corresponding machine 90a or 90b. For example, the medical fluid delivery machine 90a may have just completed its automated self-test routine and is now ready to perform disinfection procedures. The machine 90a may generate a code identifying this condition and send it to the middleware software stored on the system hub 120. The middleware software then used, for example, a look-up table to translate the code into a message such as "self-test completed, ready for disinfection" and downloaded onto the mobile communication device 200a of patient 12a or clinician 112a. Display a message in the app. The app may be programmed to provide, along with the message, a visual identifier, such as an icon, associated with the particular state to which the machine 90a belongs. The app may also provide any one or more of audio alerts such as "ringing" sounds and / or tactile alerts such as vibrations, which are viewed by the patient 12a or clinician 112a and of the machine 90. Prompt to confirm the state change.

In another example, the medical fluid delivery machine 90b may be pre-programmed to start treatment at 3:00 pm. The medical fluid delivery machine 90b may require 3 hours for self-testing and disinfection. Patient 12a or clinician 112a therefore needs to be near the machine 90b by noon to initiate pretreatment. In certain embodiments, the patient 12a or the clinician 112a sets the machine 90b as to how before the preparation time of 3 hours the patient 12a or the clinician 112a should be notified or alerted (eg, 2 hours). .. Thus, in this example, the machine 90b may generate a code at 10:00 am and send the code to the middleware software stored on the system hub 120. The middleware software then uses, for example, a look-up table to translate the code into a message such as "Begin treatment preparation in 2 hours" on the mobile communication device 200b of patient 12b or clinician 112b. Display a message on the downloaded app. The app may again be programmed to provide a visual identifier, such as a countdown timer, that counts down from 120 minutes to a timeout at zero, along with the message. The app may be one or more of audio alerts such as "ringing" sounds and / or tactile alerts such as vibrations that prompt patient 12b or clinician 112b to browse the app and review treatment readiness notifications. Can be provided. The app may also be programmed to repeat "ringing" sounds and / or tactile feedback at pre-programmed intervals (eg, 1 hour and 30 minutes) during the countdown period.

In addition to or as an alternative to providing the app on the user's communication device 200b, the middleware software in the system hub 120 is embedded in a message embedded on the device 200's unique task tracking features such as its calendar application machine 90b. It is expected to convert the code from. Most smartphone devices 200 are provided, for example, with a calendar that separates each day into time segments such as hours. Here, the message translated by the middleware software of the system hub 120 may be programmed to access the calendar of the authorized communication device 200b and populate the appropriate information into the appropriate time segment of the appropriate day. In the above example, for the appropriate day, the unique calendar software application would have its 10:00:00 AM time slot filled with a message such as "Start treatment preparation after 2 hours". Audio and / or tactile feedback signals may be provided to inform patient 12 or clinician 112 about calendar input.

Machines 90a and 90b, middleware software in central server 120, and communication devices 200a and 200b are as described above to provide any desired message to patients 12a, 12b and / or clinicians 112a, 112b. It should be understood that it may be programmed and operated and is not limited to the messages described herein. For example, patients 12a, 12b and / or clinicians 112a, 112b may also use an accompanying countdown timer to avoid the need to re-disinfect machines 90a, 90b at the end of disinfection. You may be informed that it needs to be started within the countdown time.

Here, with reference to FIG. 5, the system 110b of the present disclosure is illustrated. The system 110b in the illustrated embodiment operates with the system 10 described above, which includes the connection server 118, the system hub 120, the service portal 130, the corporate resource planning system 140, the web portal 150, and the business intelligence. Includes portals 160, which are illustrated in FIG. 5 as part of a cloud environment, but may instead be located on one or more dedicated servers. Other components of system 10 not shown in FIG. 5 may also be part of system 110a. A single medical fluid delivery machine 90 is illustrated for ease of explanation, however, multiple medical fluid delivery machines 90 may be connected to the system 110b as well. The medical fluid delivery machine 90 may be present in the home of the patient 12 (illustrated as being outside the home) or in the clinic 126a-126n for the clinician 112. The medical fluid delivery machine 90 is again connected to the connection server 118 in the illustrated embodiment, for example, using a modem 102 via a securely managed connection 116 and an internet 52 connection.

The system hub 120 in one embodiment provides middleware software that can be accessed by the mobile communication device 200, which is shown as a single device for facilitation, but a plurality of devices 200 may also be connected to the system 110b. Remember. The mobile communication device 200 of FIG. 5 includes all of the structures, functionality, and alternatives disclosed for the devices 200a and 200b illustrated in FIG. 4 (including being connected to the Internet 52). In FIG. 5, the mobile communication device 200 does not have to be, but downloads a software application (“app”) from the middleware software stored on the system hub 120 via their connection to the Internet 52. Can be. The app can be run exactly as described above in connection with FIG. 4 (including middleware software that translates the coded message from the machine 90 into a format that can be presented on the app). As an alternative, or in addition, the middleware software stored on the system hub 120 is on the unique task tracking feature of the mobile communication device 200, such as its calendar application, in any of the methods described in FIG. It may be possible to translate the code from the machine 90 into an embedded message.

As a further alternative, or in addition, the system 110b includes, for example, a cellular network 210 that interfaces between the middleware software stored in the system hub 120 and the mobile communication device 200. The cellular network 210 may include a network of cellular telephone towers operating using radio waves and / or may employ satellites. Suitable communication protocols for use with the cellular network 210 of system 110b are (i) the "Worldwide Interoperability for Microwave Access" ("WiMAX") protocol and (ii) many of the cellular phones around the world. It can be a long-range protocol such as the "Pan-European Digital Mobile Phone System" ("GSM®") protocol, which is a wide range of long-range wireless protocols that enable data communication. The network 210 may, as an alternative, or in addition, be an American electrical and electronic engineer such as (i) IEEE 802.11a, (ii) IEEE 802.11b, (iii) WEE 802.11g, or (iv) 802.11n. Medium-range protocols such as wireless local area networks (“WLAN”), which can be a protocol that is part of the Institute of Electrical and Electronics Engineers (IEEE) standard, can be adopted. Other suitable cellular technologies are CDMA, AMPS (analog), general packet radio service (“GPRS”), cdmaOne, CDMA2000, evolution data optimize (“EV-DO”), GSM® advanced high speed data rate. ("EDGE"), Universal Mobile Communication System ("UMTS"), Digital Cordless Telephone Standard ("DECT"), Digital AMPS ("IS-136 / CDMA"), and Integrated Digital Extended Network ("iDEN"). Can include.

The mobile communication device 200 is connected to the cellular network 210 via any of the methods known to those of skill in the art, for example, via a short messaging service (“SMS”) or a multimedia messaging service (“MMS”) protocol. connect. The middleware software in the system hub 120 may communicate with the cellular network 210 in several ways. In one example, the phone numbers and carriers of users 12, 112 (patient 12, patient home care partner, patient clinician 112, or all) are identified, for example, through a look-up table in middleware software. Associated with the machine 90 of. When the message / code from the specific machine 90 is received by the middleware, the middleware software sends an e-mail [user phone number] @ [carrier]. It can be programmed to send to the net. For example, if patient 001's phone number is (555) 555-5555 and patient 001's carrier is AT & T®, then patient 001's machine 90 sends a message to the middleware software in system hub 120 and receives it. At that time, the middleware software 120 sent an e-mail to 5555555555 @ att. Programmed to relay to net, it is received by patient 001's mobile communication device 200 as a text message. Those skilled in the art understand that there are multiple websites that specialize in informing text messages how to send email and outlining the details required by different carriers.

The middleware software stores each of the telephone numbers of the mobile communication device 200 and matches each of those numbers with the machine 90. When the event code is transmitted from the machine 90 to the middleware software as described above, the middleware software finds the phone number of the mobile communication device 200 associated with that machine, eg, described above. Use a lookup table like this to translate the code into the appropriate message and send the translated message to the called phone number. It is envisioned that a plurality of communication devices 200 may be associated with the same medical fluid delivery machine 90. For example, in any of the clinics 126a-126n, the telephone numbers of multiple doctors, nurses, and / or clinicians may be associated with the same machine 90. In a home environment, the phone numbers of patient 12 and the patient's clinician and / or caregiver assistant may be associated with the same machine 90.

Similarly, the telephone number for the mobile communication device 200 may be associated with the plurality of medical fluid delivery machines 90. For example, in any of the clinics 126a-126n, a single nurse may monitor multiple machines 90. If the event occurs on any of those machines during the nurse's shift, the nurse may be notified via a cellular message sent to the nurse's mobile communication device 200. This scenario is described in detail below in connection with FIGS. 7-9.

The cellular message may convey information about any of the same events discussed above regarding software applications and calendar update modes that bring information to the mobile communication device 200. For example, the medical fluid delivery machine 90 may have just completed its automated self-test routine and is now ready to perform disinfection procedures. The machine 90 may generate a code identifying this condition and send it to the middleware software stored on the system hub 120. The middleware software then uses, for example, a look-up table to translate the code into a message such as "self-test completed, ready to disinfect" and, for example, send a text message to the cellular output routine discussed above for the patient12. Alternatively, it is transmitted to the mobile communication device 200 of the clinician 112 to display a message. In an alternative embodiment, no code is needed, the machine 90 instead sends the actual text string, and the middleware software, for example, as a text message via the cellular output routine discussed above. Transfer it to the mobile communication device 200. As is known, reception of a text message on the communication device 200 includes audio prompting the patient 12 or clinician 112 to view the message, eg, tactile alerts such as "ringing" sounds and / or vibrations. Can accompany.

In another example, the medical fluid delivery machine 90 may be pre-programmed to start treatment at 3:00 pm. The medical fluid delivery machine 90 may again require 3 hours for self-testing and disinfection. Patient 12 or clinician 112 therefore needs to be by machine 90 by noon to initiate pretreatment. In certain embodiments, the patient 12 or the clinician 112 sets the machine 90 as to how before the preparation time of 3 hours the patient 12 or the clinician 112 should be notified or alerted (eg, 2 hours). .. Here, the machine 90 generates a code at 10:00 am and sends the code to the middleware software stored on the system hub 120. The middleware software then uses, for example, a look-up table to translate the code into a message such as "Start treatment preparation after 2 hours" and, for example, a text message to the cellular output routine discussed above. With audio alerts such as "ringing" sounds and / or tactile alerts such as vibrations that cause the patient 12 or clinician 112 to transmit to the mobile communication device 200 and, for example, prompt the patient 12 or clinician 112 to view the notification. Display a message.

The machine 90, the middleware software in the central server 120, and the communication device 200, as an alternative or in addition, use the cellular network 210 to provide any desired message to the patient 12 and / or the clinician 112. It should be understood that it can be programmed and operated as described above. For example, patient 12 and / or clinician 112 is also informed at the end of disinfection that treatment should be initiated within the countdown time to avoid the need to re-disinfect the machine 90. obtain. It should also be appreciated that updates of unique task tracking features, such as the calendar application of the communication device 200, can be made via internet connection or via the cellular network 210 illustrated in FIG.

Here, with reference to FIG. 6, the system 110c of the present disclosure is illustrated. The system 110c in the illustrated embodiment operates with the system 10 described above, which includes the connection server 118, the system hub 120, the service portal 130, the corporate resource planning system 140, the web portal 150, and the business intelligence. Includes portals 160, which are illustrated in FIG. 6 as part of a cloud environment, but may instead be located on one or more dedicated servers. Other components of system 10 not shown in FIG. 6 may also be part of system 110a. A single medical fluid delivery machine 90 is illustrated for ease of explanation, however, multiple medical fluid delivery machines 90 may be connected to the system 110b as well. The therapeutic fluid delivery machine 90 may be present at home of patient 12 (illustrated as being outside the home) or within the clinic 126a-126n for clinician 112. The medical fluid delivery machine 90 is again connected to the connection server 118 in the illustrated embodiment, for example, using a modem 102 via a securely managed connection 116 and an internet 52 connection. In FIG. 6, the connection server 118 and the securely managed connection 116 are used for bidirectional communication.

The system hub 120 in one embodiment provides middleware software that can be accessed by the mobile communication device 200, which is shown as a single device for facilitation, but a plurality of devices 200 may also be connected to the system 110b. Remember. The mobile communication device 200 of FIG. 6 includes all of the structures, functionality, and alternatives disclosed for the devices 200a and 200b illustrated in FIG. 4 (including being connected to the Internet 52). In FIG. 6, the mobile communication device 200 does not have to be, but downloads a software application (“app”) from the middleware software stored on the system hub 120 via their connection to the Internet 52. Can be. The app can be operated exactly as described above in connection with FIG. 4 (including middleware software that translates the coded message from the machine 90 into a format that can be presented on the app). As an alternative, or in addition, the middleware software stored on the system hub 120 is on the unique task tracking feature of the mobile communication device 200, such as its calendar application, in any of the methods described in FIG. It may be possible to translate the code from the machine 90 into an embedded message. The calendar application may, as an alternative, be updated via the cellular network 210 (shown as an alternative via the dashed leader in FIG. 6) discussed above in connection with FIG.

FIG. 6 illustrates that communication can be bidirectional between the medical fluid delivery machine 90 and the mobile communication device 210. Communication between the mobile communication device 210 and the middleware software in the server computer 120 may be via the Internet 52 and / or the cellular network 210. Communication between the middleware software in the server computer 120 can be via a connection server 118 over a securely managed connection 116, as described in detail above.

As discussed above, the home treatment machine 90 is, in one embodiment, turned off during treatment, eg, while the machine 90 and its peripherals are functioning (turned off during post-treatment disinfection). It may or may not be) Connect to the connection server 118 through its onboard connection agent 114. This prevents the home treatment machine 90 from communicating with any entity and transmitting or receiving data during treatment and disinfection, or when the machine 90 is in operation or activated. It is assumed that communication via systems 110a-110c will be protected in the same way. For example, assume that a particular machine 90 is configured via middleware software to communicate with both patient 12 and clinician 112. Here, if the patient is being treated by a machine 90, it is assumed that the connection agent 114 is blocked so that the clinician 112 does not receive notifications from the machine 90 or send commands to it at that time. To. In an alternative embodiment, the clinician 112 may be able to receive notifications from the machine 90 during treatment.

Determining when to disconnect the connection agent 114 (no communication) may depend on the content or number of mechanical states in which the systems 110a-110c desire to communicate with the mobile communication device 200. For example, suppose it is only desired to inform patient 12 or clinician 112 that patient 12 or clinician 112 needs to return to machine 90 to initiate treatment preparation 2 hours prior to treatment preparation. Here, the connection agent 114 can be turned off as soon as the patient 12 or the clinician 112 initiates the first treatment preparation step, eg, runs a self-test routine.

In another example, it may be desired that the machine 90 automatically perform a self-test routine at a preset time before the treatment is set to begin. Machine 90 notifies patient 12 or clinician 112 when it is time to begin disinfection. Here, the connection agent 114 may be disconnected when the patient 12 or the clinician 112 initiates mechanical disinfection. In a further example, it may be desired that the machine 90 notify the patient 12 when the disinfection is complete so that the patient initiates treatment within a certain amount of time from the end of the disinfection and the disinfection does not need to be repeated. .. Here, the connection agent 114 disconnects when the patient 12 or the clinician 112 initiates treatment, eg, at the start of priming where the patient is not yet connected to the treatment line, eg, the arterial line 14 or the venous line 16. Can be done.

The system 110c allows the patient 12 or the clinician 112 to remotely initiate any of the above actions (and others not expressly described herein). Patient 12 or clinician 112 may select, for example, an icon on the app displayed on the mobile communication device 200 to initiate a self-test routine or disinfection procedure. The icon selection is transmitted to the middleware software via the internet 52. The middleware software then icon to the action code sent to the machine 90 on which the connection agent 114 is turned on, for example, via a look-up table, for example, through a connection server 118 and a securely managed connection 116. It transforms the selection and allows the action code for the selected action to be sent to the machine's ACPU50, which initiates the execution of the selected action.

In an alternative embodiment, patient 12 or clinician 112 may enter, for example, a known code in a text message to select a particular action, eg, a self-test routine or disinfection procedure, performed on the machine 90. The code can be a suggestive code such as "self-test" or "disinfection". The text message is transmitted to the middleware software in the system hub 120 via the cellular network 210. The middleware software translates the textualized code into an action code for the selected action, for example, via a look-up table. Alternatively, the code entered by patient 12 or clinician 112 can be an action code such that no conversion is required. In either case, the action code is sent to the machine 90 with its connection agent 114 turned on via the connection server 118 and the securely managed connection 116, and the action code for the selected action is sent to the machine's ACPU50. Allows it to be sent, which initiates the execution of the selected action.

FIG. 6 illustrates the following exemplary 7-step sequence. In step 1, the medical fluid delivery machine 90 sends a message on the system hub 120 indicating that the machine is ready for the patient 12 to begin initiating an automated self-test routine for the machine 90 (eg, 2 hours). Send to middleware software application. In step 2, the middleware software application in the system hub 120 sends a corresponding (eg, translated) message indicating that the machine 90 is ready for the patient 12 to begin initiating an automated self-test routine. To the mobile communication device 200 of.

In step 3, a custom app downloaded to the patient's mobile communication device 200 uses audio, visual and / or tactile alerts, and associated messages to allow the patient 12's machine 90 to the patient, eg, 2 hours. Patient 12 is alerted that the start of the automated self-test routine can be started. In step 4, patient 12 uses a custom app on the mobile communication device 200 to confirm that the machine 90 should initiate its automated self-test routine.

In step 5, the patient's mobile communication device 200 sends a message to the middleware software application in the system hub 120 confirming that the patient's machine 90 is desired to initiate its automated self-test routine. In step 6, the middleware software application in the system hub 120 sends (eg, converts and sends) a message to the machine 90 indicating that the patient 12 has confirmed that the machine 90 has started its automated self-test routine. In step 7, the machine 90 initiates and implements its automated self-test routine.

Once the self-test is performed, the system 110c may perform the same steps 1-7 discussed above, except that the action is here a disinfection procedure instead of an automated self-test routine. is assumed. Here, a custom app downloaded to the patient's mobile communication device 200 may display to the patient 12 a countdown timer that reminds the patient of the amount of time the patient has before returning to the machine 90 to start treatment. It should be understood that different types of medical fluid delivery machines may have different one, two, three, or more actions that patient 12 or clinician 112 may perform before treatment is initiated. ..

For systems 110a-110c, to select the type of notification that the user wants to receive on those devices 200, eg, via the app itself, via text messages and / or via calendar notifications. It is envisioned that the application on the mobile communication device 200 will be programmed to be configurable by the user. The system hub 120 may transmit all notification types in one embodiment, and the mobile communication device 200 ignores the communication type disabled by the user. In another embodiment, the system hub 120 stores user preferences and sends only information in the selected notification type.

(C. Clinician device / server embodiment)
Referring here to FIG. 7-9, an embodiment of a system 110d having a clinician-based downloadable software application (“app”) 230 for a physician, clinician, or nurse mobile communication device or server 200. Is illustrated on the screen 232-236. As discussed above, the mobile communication device 200 can be that of patient 12 or that of doctor / nurse / clinician 112. Screen 232-236 of FIG. 7-9 illustrates that the app 230 can be used in a clinic or hospital 126a-126n, for example, a nurse is involved in a plurality of machines 90a-90n. Machines 90a-90n can again be hemodialysis machines, peritoneal dialysis machines, CRRT machines, drug and / or nutrient fluid delivery machines, and combinations thereof.

Screen 232 illustrates that the app 230 can monitor and control a plurality of machines 90, if desired. In the illustrated embodiment, the machines 90a-90n are each represented by a dedicated icon 190a-190n displayed on the screen 232 of the app 230. The icon 190a-190n in the illustrated embodiment screens 232-236 identical to that in which the machines 90a-90n are ordered within the clinic 126a-126c to help adapt the doctor / nurse / clinician 112. Ordered above.

The app 230 works with the system hub 120 as discussed herein, the system hub 120 being remote from the clinic or hospital 126a-126n, eg, one or more of the machines 90a-90n. It is expected to be maintained by the manufacturer of. The app 230 may first be developed, for example, in the product development 128 illustrated in FIG. The app 230 may then be transmitted from the product development 128 to the system hub 120 via the service portal 130 as illustrated in FIGS. 1 and 7. Any nurse, clinician, or physician 112 authorized to download App 230 may do so from System Hub 120. The system hub 120 then maintains the middleware software to work with the app 230 in the manner described above in the systems 110a-110c.

In an alternative embodiment, clinics 126a-126n may maintain their own local area network, each operating with a local system hub 220. The app 230 may again be developed by product development 128 (FIG. 1) and delivered via the service portal 130 to the local system hub 220 of the clinic 126a-126n operating with the entire system 10. Each nurse, clinician, or physician 112 authorized to download app 230 does so from the local system hub 220. The local system hub 220 then maintains the middleware software to work with the app 230 in the manner described above for the system hub 120 in the systems 110a-110c. In a further alternative embodiment, the app 230 may be developed by the clinic 126a-126n and stored on its local system hub 220.

The middleware software of the system hub 120 or the local system hub 220 updates the status of each machine 90a-90n. The nurse, clinician, or physician 112 may indicate the current status of each machine 90a-90n, eg, "pause", "self-test", "disinfect", or as illustrated in screen 234 of FIG. The icon 190a-190n may be selected at any time to confirm "during patient treatment". Other status markers are also envisioned and can differ for different types of machines. The nurse, clinician, or physician 112 is then "pausing," "self-testing," "disinfecting," or "patient-treating" to return to the home icon 190a-190n as illustrated in FIG. You can choose one of them.

As discussed above, it is envisioned to turn off the connection agent 114 for each machine 90 when the machines are running, especially when the patient 12 is connected to the machines. However, the connection of each machine 90a-90n of the clinic 126a-126n so that the middleware software in the system hub 120 or the local system hub 220 can receive the status change from each machine 90a-90n to "patient being treated". It is also envisioned that the agent 114 can remain on until the end of disinfection. In addition, since each machine 90a-90n is aware of its scheduled treatment period, the machine may send the scheduled duration to the middleware software, which is a status change regarding "patient treatment in progress". Together with the duration in the form of a countdown timer. Here, when the nurse, clinician, or doctor 112 then selects "Patient is being treated" in FIG. 8, they have a countdown timer indicating the time of remaining treatment as illustrated in FIG. It is possible to confirm.

With respect to the countdown timer, the connection agent 114 allows the machines 90a-90n to send time remaining data to the system hub 120, thereby allowing the app 230 to have the actual time remaining for each machine 90 undergoing a timed process. Is expected to be displayed. The app 230 assumes an alarm or other delay that the machine 90 may suffer. During an alarm situation, the corresponding icons 190a-190f may display a message such as "alarm" or "safe mode". The nurse, clinician, or doctor 112 may then select the countdown time of FIG. 9 to return to the home icons 190c, 190d, and 190h illustrated in FIG. 7.

The nurse, clinician, or physician 112 allows or does not allow status changes for the machine 90a-90n to be visually, audibly, and / or tactilely alerted. You can also toggle the alert on / off icon 238. When the alert on / off icon 238 is toggled to "on", app 230 of the mobile communication device 200 will receive visual, audible, and / or tactile alerts, eg, (i) ". It provides "self-test start", (ii) "self-test complete", (iii) "disinfection start", (iv) "disinfection complete", (v) "treatment start", (vi) "treatment complete". Let's go. In certain embodiments, the code for (i)-(v) is transmitted via the machines 90a-90n through the securely managed connections 116, connection server 118, and system hub 120 or local system hub 220, and middleware. Converted by software and transferred to app 230, it updates the appropriate icon 190. In various embodiments, "(vi) treatment completion" is either (a) transmitted via the machine 90a-90n using the activated connection agent 114, or (b) the appropriate icon 190a-. It can be inferred when the 190n countdown timer expires and if the connection agent 114 can still be off.

If the alert on / off icon 238 is toggled off, for example if the nurse, clinician, or doctor 112 does not want to be interrupted at a given moment, the icons 190a-190n are described above. Still updated to, but no audible and / or tactile alerts are provided. However, the nurse, clinician, or physician 112 may still actively view the status of each machine 90a-90n by selecting the associated icon 190a-190n.

Screens 232-236 illustrate action buttons 240a-240b (collectively referred to herein as action buttons 240, or generally individually referred to as action buttons 240). Any number of action buttons 240 may be provided for any type of pretreatment action required for any modality, eg hemodialysis, peritoneal dialysis, CRRT, drug and / or nutritional fluid delivery. .. In the illustrated embodiment, the action button 240a is for initiating a self-test for the machine 90, while the action button 240b is for initiating a disinfection sequence for the machine 90.

In one embodiment, when the self-test button 240a is selected, any machine 90a-90n capable of performing the self-test at that time will be highlighted with its corresponding icon 190a-190n. The nurse, clinician, or doctor 112 selects any icon 190 for the machine 90 that the nurse, clinician, or doctor 112 wants to perform a self-test. The selected icon 190 can then be transformed into a "confirm" button that the nurse, clinician, or physician 112 needs to press again to have the selected machine 90 perform its self-test. App 230 of the mobile communication device 200 then sends the corresponding self-test code to the middleware software in the system hub 120 or local system hub 220, which in turn sends the self-test code to the self-test start command, if necessary. The translated command is sent to the connection agent 114 of the selected machine 90 via the connection 116, which is securely managed via the connection server 118, which transfers the command to the machine's ACPU 50. The ACPU50, in turn, initiates a self-test.

In the illustrated embodiment, when the disinfection button 240b is selected, any machine 90a-90n capable of performing disinfection at that time highlights its corresponding icon 190a-190n. The nurse, clinician, or doctor 112 selects any icon 190 for the machine 90 that the nurse, clinician, or doctor 112 wants to perform disinfection. The selected icon 190 can again be transformed into a "confirm" button that the nurse, clinician, or doctor 112 needs to press again to have the selected machine 90 perform the disinfection. App 230 of the mobile communication device 200 then sends the corresponding disinfection code to the middleware software in the system hub 120 or local system hub 220, which, if necessary, translates the disinfection code into a disinfection start command. The command is sent to the connection agent 114 of the selected machine 90 via the connection 116, which is securely managed via the connection server 118, the agent 114 transfers the command to the machine's ACPU50, and the ACPU50 in turn. , Start disinfection.

The procedure thus described for the action button 240 is also implemented in the system 110c and may be implemented for other machine commands that may vary depending on the type of machine 90. It is safe enough for clinic 126a to leave the connection agent 114 on during treatment or part of treatment by one or more nurses, clinicians, or doctors 112 present in the clinic. It is also assumed that it can be decided. In such cases, the nurse, clinician, doctor 112 may control in-treatment activity with respect to the machine 90. For example, a nurse, clinician, doctor 112 receives and responds to alarms / alerts via app 230 on a mobile connected device 200, starts and stops pumps and other aspects of treatment, disinfects. It can start and stop, start and stop priming, and so on.

Each of the systems 110a-110d operates using some form of addressing scheme. As discussed above, the connection server 118, in one embodiment, delivers data in the appropriate form to the appropriate machine 90 and data from the machine 90 to the appropriate destination in its appropriate form. Provided to ensure that. In one embodiment, when the machine 90 transmits data to the system hub 120 or the local system hub 220 for delivery to the mobile communication device 200, the data provides a machine identifier that identifies the machine 90 that transmitted the data. Will be done. The connection server 118 knows each mobile communication device 200 to which the data of the specific machine belongs, and instructs the system hub 120 or the local system hub 220 which communication device 200 should receive the data. The system hub 120 or local system hub 220 may then transform the data as discussed herein. For example, when transmitting the converted data, the system hub 120 or the local system hub 220 may remove the machine identifier from the data because the machine identifier is no longer needed. However, in system 110d, the machine identifier may be delivered, for example, with the transformed data so that the app 230 knows which icon 190a-190n to populate with new data. Here, the app 230 may remove the machine identifier when it is no longer needed.

In one embodiment, when the mobile communication device 200 transmits data to the system hub 120 or the local system hub 220 for delivery to the machine 90, the data identifies the mobile communication device 200 that transmitted the data. A device 200 identifier is provided. The system hub 120 or the local system hub 220 may or may not convert data from the mobile communication device 200, as discussed above, in which case the mobile communication device 200 identifier connects. Maintained for server 118. The connection server 118 knows, for example, which machine 90 should receive the converted data for each mobile communication device 200, for example, transmitting the converted data to each associated communication device 200. .. Once delivered to the machine 90, the connection server 118 may remove the mobile communication device 200 identifier from the data as it is no longer needed.

The app 230 as described above allows a nurse, clinician, or physician 112 to set up, monitor, and possibly control treatment in the medical fluid delivery machine 90. It is envisioned to provide similar functionality via the app to the patient 12 or the caregiver for the patient 12 at the patient's home (dashed line frame in FIG. 1). Connectivity can be identical to that shown in FIG. 7-9. However, the setting is not the clinic 126a-126n, but instead a home or other non-clinical location such as a business or vacation location. In addition, typically there is only a single machine 90, not multiple machines 90a-90n. However, a single patient 12 can be treated via a plurality of machines 90, each of the plurality of machines 90 can be supported by an app as described herein. If patient 12 is at home but away from machine 90, the app will provide useful information such as the amount of time left to start or complete a startup procedure task, disinfection procedure, or self-test routine. Can be provided. When the patient is being treated by the machine 90, the patient can see the information on its user interface 122, which itself can be a tablet as illustrated in FIG. However, there may be caregivers, such as spouses, friends, or home nurses, who assist the patient 12 at home during treatment. The caregiver receives status updates, startup procedure remaining time, disinfection remaining time, priming remaining time, treatment remaining time, information about whether patient 12 is connected to the machine 90, alerts, alarms, etc. Benefit from. The app in one embodiment requires that the login and password associated with the patient be entered before it can be downloaded to the caregiver's mobile communication device 200, whereby only authorized persons are the patients. View treatment data or information.

(II. Patient Involvement Embodiment)
The exemplary medical fluid delivery data transfer system 10 disclosed above in connection with FIG. 1-9 enhances patient involvement in medical fluid delivery therapies such as dialysis treatment, renal failure treatment, and / or peritoneal treatment. It is configured as follows. FIG. 10 shows an exemplary medical fluid data transfer system 1000 similar to the medical fluid data transfer system 10 discussed in connection with FIG. 1-9, according to an exemplary embodiment of the present disclosure. An exemplary medical fluid data transfer system 1000 (eg, a mobile platform) provides features for controlling and reporting treatment-related information to patients who improve treatment transparency, and / or educational materials and / or. It is configured to improve patient involvement and / or compliance with treatment by providing access to real-time assistance from the clinician.

An exemplary medical fluid data transfer system 1000 includes, for example, a personal mobile communication device 200a operated by a patient. The medical fluid data transfer system 1000 also includes a blood pressure monitor 104, a measuring instrument 106, and a home therapy machine 90, which are similar to the respective devices discussed above in connection with FIG. 1-9. The personal mobile communication device 200a, the home therapy machine 90, the blood pressure monitor 104, and the measuring instrument 106 may be located, for example, in the patient's home, self-service clinic, and / or serviced medical clinic.

The home therapy machine 90 may include any type of hemodialysis machine, peritoneal dialysis machine, CRRT machine, drug and / or nutrient fluid delivery machine, and combinations thereof. The home therapy machine 90 may provide, for example, continuous circulating peritoneal dialysis (“CCPD”), tidal current automated peritoneal dialysis (“APD”), and continuous fluid peritoneal dialysis (“CFPD”). The home therapy machine 90 can typically perform an automatic drain, fill, and retention cycle while the patient is asleep.

The peritoneal dialysis solution may contain a solution or mixture containing 0.5% to 10%, preferably 1.5% to 4.25% glucose (or more generally glucose). Peritoneal dialysis dialysis fluid may include, for example, Diamond®, Physioneal®, Natural®, and Extraneal® dialysate marketed by the transferees of the present disclosure. The dialysate may additionally or, as an alternative, contain a percentage of icodextrin.

In both hemodialysis and peritoneal dialysis, "adsorbent" technology removes urinary toxins from waste dialysate and reinjects therapeutic agents (such as ions and / or glucose) into the treated fluid of the patient. It can be used to reuse the fluid to continue dialysis. One commonly used adsorbent is made from zirconium phosphate, which is used to remove the ammonia generated from the hydrolysis of urea. Typically, large amounts of adsorbents are needed to remove the ammonia generated during dialysis treatment.

The exemplary weigh scale 106 includes any device configured to measure the mass of the patient or therapeutic component. For example, the weigh scale 106 may weigh a patient before, during, and / or after renal failure therapy treatment. In addition, or as an alternative, the weigh scale 106 may measure the supply or drainage bag to track renal failure therapy. Specifically, the weigh scale 106 can be used to measure the amount of UF removed or the amount of fluid provided to the patient. The weigh scale 106 may display a digital value indicating the weight. Alternatively, the weigh scale 106 may display a physical scale or dial aligned with the marker to indicate the measured weight. In some embodiments, the weigh scale 106 is placed in a separate window before, during, and / or in a separate window so that when medical information is recorded, patient input is required to view all values. Subsequent weight values can be stored.

The exemplary blood pressure monitor 104 includes any device configured to measure a patient's blood pressure and / or pulse. For example, the blood pressure monitor 104 may measure a patient's blood pressure before, during, and / or after renal failure therapy treatment. The blood pressure monitor 104 may display a digital value indicating the patient's blood pressure. Alternatively, the blood pressure monitor 104 may display a physical scale with a dial aligned with the numerical value to indicate the measured blood pressure. In some embodiments, the blood pressure monitor 104 is provided with a separate window before, during, and / or after treatment so that when medical information is recorded, patient input is required to view all values. Can memorize the blood pressure value of. The blood pressure monitor 104 may be integrated with the home therapy machine 90. In another embodiment, the blood pressure monitor 104 may include a wearable sensor such as a smartwatch or fitness tracking device.

In addition to acquiring medical information (eg, medical device data) from medical devices 90, 104, and 106, the exemplary personal mobile communication device 200a also acquires medical information from the patient and / or therapeutic consumable item 1006. Can be. FIG. 10 shows, for example, renal failure therapy medical device filters, disposable cassettes, blood line sets, drug delivery line sets, and containers (eg, dialysate concentrate containers, blood anticoagulant containers, drug containers, and / or purified water. An example of a consumable item 1006 including a container) is shown. The consumable item 1006 may also include an adsorbent cartridge or any other disposable or substance source for medical treatment. The consumable item may include an identifier 1008 configured to provide medical information in the form of consumable information or consumable data. For example, the identifier 1008 may include information identifying the type, serial number, and / or characteristics of the consumable item. In some cases, the consumable item 1006 may also include a label containing medical information such as chemical composition properties. The patient or clinician uses the personal mobile communication device 200a to record an image of the identifier 1008, an image of the marker on the consumable item 1006, and / or an image of the consumable item 1006 itself and used during treatment. Document the substance.

The personal mobile communication device 200a may be a wired connection (eg, USB connection) or a wireless connection (eg, Bluetooth®, WiFi®, Zigbee®, Z-Wave®, wireless USB, etc. Alternatively, it may be communicably coupled to a home therapy machine 90, a blood pressure monitor 104, and / or a meter 106 via a wireless local area network (“WLAN”). In another example, the personal mobile communication device 200a is not communicably coupled to any one of the home therapy machine 90, the blood pressure monitor 104, and / or the measuring instrument 106. In these other examples, the patient may manually enter the data displayed by the home therapy machine 90, blood pressure monitor 104, and / or meter 106 into the personal mobile communication device 200a. In addition, or as an alternative, in these other examples, the patient uses the camera 1004 of the personal mobile communication device 200a to display the data displayed by the home therapy machine 90, the blood pressure monitor 104, and / or the measuring instrument 106. One or more images of (or an identifier placed on it) may be recorded.

Collectively, the blood pressure monitor 104 and the measuring instrument 106 are referred to as medical devices. The medical fluid data transfer system 1000 includes infusion pumps (eg, syringe pumps, linear peristaltic pumps, high capacity pumps (“LVP”), portable pumps, multi-channel pumps), oxygen sensors, breath monitors, glucose meters, blood pressure monitors, It should be understood that it may include additional medical devices such as electrocardiogram (“ECG”) monitors, weigh scales, and / or heart rate monitors. In another example, the medical fluid data transfer system 1000 may include fewer medical devices and / or medical devices integrated together (eg, a blood pressure monitor 104 integrated with a home therapy machine 90).

In some embodiments, the personal mobile communication device 200a is configured to record, display, and / or populate the patient medical record with medical information or data. As disclosed herein, medical information or data includes medical device data and patient data, which are created by medical devices, patients, and / or consumable items used by medical devices. May refer to data or information generated by or otherwise related to it. For example, medical information includes prescription or programming information used by medical devices to provide treatment. Medical information includes sensed data such as fluid pressure, flow rate, conductivity, concentration, temperature, and patient data. As provided herein, patient data (eg, vital sign data) includes perceived patient physiological information such as blood pressure, weight, heart rate, etc. of the patient. The medical information may also include subjective information such as information about the patient's mood (eg, tired, tired, satisfied, excited, etc.). Medical information can be displayed on the screen of the medical device and can be printed on a sign or medical device provided or attached by the physical dial or display of the medical device. Thus, medical device data or medical information includes medical device settings, medical device readings, and / or patient readings.

Medical information also refers to the information contained on the identifier attached to the patient or therapeutic consumable item. Specifically, medical information may include information conveyed by a patient identifier provided on the patient's wristband to identify the patient. The medical information also includes information about the consumable item, which may identify the characteristics of the consumable item such as the consumable item type, the consumable item model, and / or the level of glucose in the supply bag of the renal failure therapy solution. ..

Treatment data or treatment information refers to data generated and / or transmitted by the home therapy machine 90 of FIG. 1-10. The treatment information may include the volume of infused fluid, the amount of extrafiltration UF removed from the patient, and / or the treatment time. The treatment information may also include alarms, alerts, and / or diagnostic information generated by the home therapy machine 90. Generally, treatment information is transmitted from the home therapy machine 90 to the clinician server 200b. In some embodiments, the treatment information may be recorded within the personal mobile communication device 200a. In these embodiments, the treatment information is referred to as medical information and / or may be included / processed as medical information.

As shown in FIG. 10, some of all of the medical devices 90, 104, and 106 may include an identifier 1012 configured to store a unique identification number. The identifier 1012 may encode, for example, the assigned device number, serial number, hardware number, model number, and / or device type of each medical device 90, 104, and 106. For example, the identifier 1012b of the home therapy machine 90 may store the assigned device number. The personal mobile communication device 200a reads the identifier 1012b from the screen of the machine 90, for example, to determine the medical device type for subsequent analysis and the identification of medical information in the recorded images. In some embodiments, the identifier 1012 may more generally indicate a model or type of medical device. For example, the identifier 1012c may indicate that the device 106 is a weigh scale and / or may indicate the model number of the weigh scale.

Identifier 1012 may include machine readable markings such as, for example, barcodes or quick response (“QR”) codes. Identifier 1012 may also include human readable text such as a serial number, asset number, or hardware number. In some embodiments, the identifier 1012, such as the identifier 1012b indicated for the home therapy machine 90, may be printed on an article physically attached to the housing of the respective medical devices 90, 104, and 106. In addition, or as an alternative, the identifier 1012 may be displayed on some screens of all of the medical devices 90, 104, and 106. For example, the clinician may select a control interface and have the home therapy machine 90 display a window with the identifier 1012b on the screen. Still in other embodiments, the identifier 1012 may be included within a radio frequency (“RF”) microchip such as an RFID chip or NFC chip.

Exemplary medical devices 90, 104, and 106 may also include one or more control interfaces for providing control instructions. For example, the home therapy machine 90 includes a control interface 1014. The control interface may include a button, a control panel, or a touch screen. The control interface may be configured to allow the user to navigate to a window or user interface on the screen of the respective medical devices 90, 104, and 106. The control interface may also provide instructions for operating or controlling the respective medical devices 90, 104, and 106.

As illustrated in FIG. 10, the exemplary fluid data transfer system 1000 is a web portal (similar to each device discussed in connection with FIGS. 1-9) for communicating with the personal mobile communication device 200a. Includes 150, a system hub 120, and a clinician server 200b. The web portal 150, the system hub 120, and / or the clinician server 200b transmit medical information from the patient's medical record (stored in the clinician database 1010) to the personal mobile communication device 200a. In addition, the web portal 150, the system hub 120, and / or the clinician server 200b may provide the personal mobile communication device 200a with access to educational materials or real-time help sessions with the clinician. The exemplary web portal 150, system hub 120, and / or clinician server 200b are also configured to allow the personal mobile communication device 200a to provide medical information for inclusion in a patient's medical record. To.

The exemplary fluid data transfer system 1000 of FIG. 10 also includes a connection server 118 communicably coupled to the home therapy machine 90. As discussed above in connection with FIG. 1-9, the connection server 118 provides bidirectional communication between the home therapy machine 90 and the clinician server 200b and / or the clinician database 1010. The home therapy machine 90 may connect to the connection server 118 via the Internet.

In the illustrated example of FIG. 10, the exemplary personal mobile communication device 200a includes a processor 1016 that communicates with a memory 1018 that stores instructions. At least some of the instructions define or define application 1002, which, when executed by processor 1016, causes processor 1016 to provide features that improve patient involvement and / or compliance with treatment. Processor 1016 may include digital and analog circuits structured as microprocessors, application specific integrated circuits (“ASIC”), controllers and the like. Memory 1018 includes a volatile or non-volatile storage medium. In addition, memory 1018 may include any solid or disk storage medium.

As discussed in more detail below, application 1002 features display treatment progress information, control of treatment programs activated by the home therapy machine 90, medical information recording, educational material display, and / or. Includes initiating a help session with a clinician. Application 1002 may be rich in features or few in features. The feature-rich application is configured for smartphones and takes advantage of the unique graphics, touch screen, and processing power of the personal mobile communication device 200a. Low-feature applications are configured to run on cellular phones with relatively unsophisticated graphics and reduced processing power. Cellular phones may not include a touch screen or may instead have a touch screen with limited capabilities.

In some embodiments, the personal mobile communication device 200a may not include application 1002. Alternatively, the personal mobile communication device 200a may use a unique application, or other installed application, to communicate with the clinician server 200b. For example, the personal mobile communication device 200a may use a text, SMS, or email program to communicate with the clinician server 1020.

The exemplary clinician server 200b includes application 1020, such as application 230, described in connection with FIG. 1-9. Application 1020 is configured to communicate with the personal mobile communication device 200a to provide improved patient involvement and / or compliance. In some embodiments, the exemplary application 1020 is configured to facilitate the storage of medical information (recorded by the personal mobile communication device 200a) into one or more patient records in the database 1010. Application 1020 is one or more interfaces for providing treatment progress data and / or medical information to application 1002 for display on display interface 1022 (eg, touch screen) on personal mobile communication device 200a. Alternatively, it may include an application programming interface (“API”). Application 1020 on the clinician server 200b may provide educational material and / or facilitate a communication session between the personal mobile communication device 200a and the clinician device 152 in response to a request from application 1002.

In some cases, application 1002 on the personal mobile communication device 200a and / or application 1020 on the clinician server 200b is a medical fluid data transfer that complies with a health level 7 (“HL7”) standard (eg, a medical standard). It is configured to translate or otherwise provide medical information to the clinician database 1010 of other devices in the system 1000. This conversion allows medical information to be stored in the HL7 format regardless of the format as it is input to the personal mobile communication device 200a. Application 1002 and / or application 1020 may act as a network conduit for seamlessly propagating relevant medical information from a medical device to a patient medical record when a gap in network or device connectivity is present.

FIG. 11 shows a schematic diagram illustrating an operating module of application 1020 in the clinician server 200b of FIG. 10 according to an embodiment of the present disclosure. Application 1020 may include a registration module 1102 configured to register the home therapy machine 90 and / or the personal mobile communication device 200a in a particular patient and / or patient medical record stored in the clinician database 1010. As described in more detail in connection with FIG. 12, registration may include determining the type of personal mobile communication device 200a to format subsequent communication.

Application 1020 may also include a data acquisition module 1104 configured to receive treatment and / or medical information from a registered home therapy machine 90 and / or personal mobile communication device 200a. In addition, application 1020 is a data access module 1106 to transmit medical information stored in one or more patient records associated with a patient, or to provide access to it otherwise. May include. Application 1020 may further include an education module 1108 configured to provide access to educational materials or help documents for patients regarding the operation of their own treatment and / or home therapy machine 90. In addition, application 1020 may include a treatment control module 1110 that allows the patient (or clinician) to modify (or modify) the treatment program performed by the home therapy machine 90. Application 1020 may additionally include an auxiliary module 1112 that creates a real-time communication session between the personal mobile communication device 200a and the clinician device 152.

Each of the exemplary modules 1102-1112 is configured to improve patient involvement in medical fluid delivery therapy, thereby improving patient compliance with prescribed treatment. Module 1102-1112 is shown, but it should be appreciated that the exemplary application 1020 may include fewer or additional modules. For example, in some embodiments, the education module 1108 and the auxiliary module 1112 may be omitted. The following sections provide further description for each of modules 1102-1112.

As discussed below, each of the modules 1102-1112 is configured to communicate with the personal mobile communication device 200a and / or the clinician device 152. In some embodiments, communication from the personal mobile communication device 200a may generally be addressed to the clinician server 200b, the web portal 150, the connection server 118, and / or the system hub 120. The message may be routed internally to different modules 1102-1112 based on the content and / or the identifier. For example, application 1002 may provide an identifier in the header to specify the module 1102-1112 to receive the message. For text-based messages, the router at the clinician server 200b may determine the destination module 1102-1112 based on the message content or previous messages. For example, the router may determine that the message received corresponds to the message previously transmitted by the data acquisition module 1104. Based on this correspondence, the router sends the message received for processing via the data acquisition module 1104.

(A. Registration module embodiment)
The exemplary registration module 1102 is configured to register the personal mobile communication device 200a and / or the home therapy machine 90 in the patient's medical records stored in the clinician server 200b and / or in the database 1010. The exemplary registration module 1102 is configured to provide different types of registration, which is to determine how information should be displayed to the patient based on the type of device to be registered, the data access module 1106. Used by. In addition, the data acquisition module 1104 determines how treatment and / or medical information should be obtained based on the registration information.

The registration module 1102 is configured to store registration information in a registration file stored in the clinician database 1010. The registration file is information indicating the registered personal mobile communication device 200a, information indicating the registered home therapy machine 90, and / or for each patient or patient activation code (“PAC”). It may specify instructions as to whether application 1002 is installed on the personal mobile communication device 200a. In some embodiments, the enrollment file (or information from the enrollment file) may be included in the patient's medical record.

In some embodiments, there are different registration scenarios. For example, the patient may register the home therapy machine 90 while registering the personal mobile communication device 200a by downloading the application 1002. In this scenario, registration module 1102 records that the patient installed application 1002 on the personal mobile communication device 200a and registered the home therapy machine 90 (either separately or through application 1002). Based on this registration, the data acquisition module 1104 prompts that the application 1002 installed on the registered personal mobile communication device 200a should guide the patient to obtain medical information, or otherwise prompt. Decide what to do. In addition, the data acquisition module 1104 determines that treatment information should be received from the home therapy machine 90 rather than via the personal mobile communication device 200a. Accordingly, the data acquisition module 1104 may send a message to application 1002 and disable the user interface to obtain treatment information from the home therapy machine 90 (although manual replacement is still prescribed for the patient). If so, enable the user interface for manual replacement). If the home therapy machine 90 is not registered, the data acquisition module 1104 causes application 1002 to display a user interface in order to obtain treatment information from the home therapy machine 90 in application 1002. Through registration, data access module 1106 determines that information should be displayed through application 1002, and accordingly APIs and / or others that are compatible with or configured for application 1002. Use the data read component of.

If the patient is enrolling without downloading and / or installing application 1002, the data acquisition module 1104 determines that data acquisition should be prompted or guided. For example, the data acquisition module 1104 transmits a text message and / or email to the registered personal mobile communication device 200a (if the home therapy machine 90 is not registered) with respect to certain medical and / or treatment information. Can prompt the patient. The information in the message defines the data needed by the patient. This remote guidance can be used for the featureless personal mobile communication device 200a, but it is also used for smartphones where the patient does not want to download or install the application 1002 on the feature rich device. obtain.

The data access module 1106 may also be configured to display information differently from the patient's medical records if application 1002 is not installed. For example, instead of sending data that plugs into a well-defined feature-rich user interface, the data access module 1106 is in a photo transmitted over text to the personal mobile communication device 200a for viewing. Data can be rendered. In addition, or as an alternative, the data access module 1106 may transmit the stored medical record information as text to the personal mobile communication device 200a. Therefore, even if application 1002 is not installed, application 1020 on the clinician server 200b is configured to provide access to the data to the patient using a unique application on the personal mobile communication device 200a. ..

FIG. 12 shows a schematic diagram illustrating communication between the home therapy machine 90 of FIGS. 10 and 11, the personal mobile communication device 200a, and the clinician server 200b according to an exemplary embodiment of the present disclosure. First, the home therapy machine 90 is registered with the clinician server 200b via the registration module 1102 of FIG. Otherwise, the clinician server 200b will not have information about patient record data from the home therapy machine 90 to be stored. In some embodiments, the home therapy machine 90 is preprogrammed with destination address information about the connection server 118, the system hub 120, and / or the clinician server 200b. The destination address may include an Internet Protocol (“IP”) address and / or a hypertext transfer (or transport) protocol (“HTTP”) address.

During setup, the patient (or clinician) enters the patient activation code (“PAC”) into the home therapy machine 90. The PAC is originally generated and stored in the clinician server 200b and is provided to the patient when the patient receives the home therapy machine 90. The PAC may include a patient identifier or other code that is unique to the patient. Registration module 1102 in the clinician server 200b stores the generated PAC in one or more patient records and / or registration files associated with the patient. After inputting the PAC, the home therapy machine 90 generates and transmits a message 1202 containing the PAC. The message may also include the hardware identifier of the home therapy machine 90 and / or the IP address assigned to the home therapy machine 90. The home therapy machine 90 transmits the message 1202 to a pre-programmed address, in this case the connection server 118. The exemplary connection server 118 relays the message 1202 to the system hub 120, which routes the message to the clinician server 200b. Registration module 1102 in the clinician server 200b uses PAC to register the home therapy machine 90 with the patient. Registration comprises, for example, associating the identifier of the home therapy machine 90 with the patient medical record of the patient. Registration may also include allowing the clinician server 200b to store the IP address of the home therapy machine 90 and allow the message to be transmitted to the home therapy machine 90. After enrollment, the data acquisition module 1104 of the clinician server 200b stores the treatment information received from the home therapy machine 90 in one or more medical records associated with the patient.

The exemplary personal mobile communication device 200a is also configured to be registered with the clinician server 200b via the registration module 1102. To register, the personal mobile communication device 200a may download or otherwise receive the application 1002 via one or more messages 1204 from the clinician server 200b (or a third party application store). .. In certain embodiments, during registration of the home therapy machine 90, the patient (or clinician) may provide the telephone number of the personal mobile communication device 200a. The registration module 1102 uses a telephone number to transmit message 1204 as a text message. The message may include a hyperlink to a location (eg, database 1010 or third party website) that provides application 1002 for download to the personal mobile communication device 200a. In another example, message 1204 may include an attachment that, when executed, installs application 1002 on personal mobile communication device 200a. Instead of providing a phone number, the patient may instead provide an email address during registration of the home therapy machine 90. Therefore, message 1204 includes an e-mail message with a file or hyperlink for installing application 1002 on the personal mobile communication device 200a.

In another embodiment, message 1204 may allow the patient to register two different methods, depending on the capabilities and / or personal preferences of his personal mobile communication device 200a. Message 1204 includes text prompting the patient to respond to the text if the patient wishes to register his or her personal mobile communication device 200a as a featureless device. The reply to message 1204 is provided via text message 1206, which is routed to registration module 1102. In turn, the registration module 1102 registers the personal mobile communication device 200a with an instruction that the application 1002 is not installed. In some cases, message 1204 may also include text or hyperlinks that, if desired, prompt the patient to select a hyperlink or otherwise obtain application 1002. Message 1204 may also provide a prompt or option to select a device type such as an Apple® device or Android® device. During the registration process, the registration module 1102 registers the personal mobile communication device 200a based on the information provided by the patient and / or the information read from the personal mobile communication device 200a.

The patient may register the personal mobile communication device 200a after the application 1002 is installed. In certain embodiments, to enroll, the patient completes the enrollment form or field provided by application 1002. The form or field is configured to accept the patient's PAC. The form or field may also include a prompt for the patient's name, email address, home address, phone number, etc. Information from the form or field is transmitted to the web portal 150 in one or more messages 1206, which transmits the message 1206 to the system hub 120 for routing to the clinician server 200b. Message 1206 may also include device type information for the personal mobile communication device 200a (as determined by application 1002).

In some cases, application 1002 may consist of the destination address of the web portal 150, the destination address being used to carry the message. In another case, message 1206 may be provided to the API on the web portal 150 to register application 1002 on the clinician server 200b. Still in other cases, application 1002 transmits message 1206 as one or more text messages or email messages to the web portal 150, where the web portal 150 is a telephone number, IP address, email address, or other. Assigned an address). The exemplary registration module 1102 uses the PAC in message 1206 to register the personal mobile communication device 200a in medical records and / or registration files stored in database 1010. At this point, both the home therapy machine 90 and the personal mobile communication device 200a are enrolled in the same patient on the clinician server 200b.

As mentioned above, in some embodiments, the personal mobile communication device 200a may not include an application. In these embodiments, the personal mobile communication device 200a may communicate with the clinician server 200b via text messages or through a web browser. Therefore, the registration module 1102 of the clinician server 200b may transmit a text message with a hyperlink to a database or web page to complete the registration to the personal mobile communication device 200a. Alternatively, the text message may include a prompt for the patient to respond with his or her PAC. Providing PAC through any of these registration processes allows the registration module 1102 to provide the personal mobile communication device 200a (eg, telephone number, hardware address, or IP address) with appropriate patient medical records and / or Allows you to associate with a registration file.

(B. Data acquisition module embodiment)
FIG. 12 also illustrates data communication between the home therapy machine 90, the personal mobile communication device 200a, and the clinician server 200b. During operation, the home therapy machine 90 generates treatment information and status information (eg, medical information). As discussed above in connection with Figure 1-9, treatment information includes the volume of infused fluid, the amount of extrafiltration (“UF”) removed from the patient, and / or treatment time. .. Status information includes alarms, alerts, or diagnostic information. Before or after treatment, the home therapy machine 90 generates one or more messages 1208 with medical information, which is transmitted to the connection server 118. In turn, the connection server 118 routes the message 1208 to the system hub 120, which routes the message 1208 to the data acquisition module 1104 of the clinician server 200b. After receiving, the data acquisition module 1104 stores the medical information in a designated section of the patient's medical record (eg, patient medical record 1302 in FIG. 13). Message 1208 may include an identifier or address of the home therapy machine 90, which is used by the data acquisition module 1104 to find suitable medical records in database 1010.

The exemplary home therapy machine 90 may be configured to encode, label, or otherwise identify the medical information being transmitted using metadata or other data identification techniques. Coding or labeling allows the data acquisition module 1104 (or the interface on the server 200b) to determine the context of the medical information for writing the medical information into the appropriate fields of the patient record. In addition, or as an alternative, coding or labeling may be stored in the record, which will be used later to retrieve and display medical information.

FIG. 12 illustrates that the personal mobile communication device 200a transmits medical information or medical information to the clinician server 200b. As described in more detail below, the personal mobile communication device 200a is configured to obtain medical information from medical devices including devices 90, 104, and 106. Obtaining medical information means receiving information manually entered by the patient via a wired or wireless connection and / or processing images recorded by camera 1004 of the personal mobile communication device 200a. May include. The medical information obtained is packaged in one or more messages 1210 and transmitted to the web portal 150 by the personal mobile communication device 200a. Message 1210 is a text message, email message, or web-based message (eg, an HTTP message, an extended markup language (“XML”) message, a Java® Script object notation (“JSON”) payload, etc.). possible. In some embodiments, the personal mobile communication device 200a may format the obtained medical information into one or more data fields prior to transmission. In general, the medical information obtained in the personal mobile communication device 200a is less structured than the medical information generated by the home therapy machine 90. Therefore, the data acquisition module of the personal mobile communication device 200a and / or the clinician server 200b processes at least a portion of the medical information to provide the appropriate context or structure for inclusion in the patient medical record. To carry out. An example of the processing performed is described in more detail below.

FIG. 13 illustrates an exemplary patient data structure 1300 stored on the clinician database 1010 of FIG. 10 according to an exemplary embodiment of the present disclosure. Patient data structure 1300 contains separate patient records for different patients. In the illustrated example, the data structure 1300 includes a patient medical record 1302 for a patient associated with the identifier "DCM31913" and a patient medical record 1304 for a patient associated with the identifier "GAM41215". Data structure 1300 may include additional patient medical records.

As shown in FIG. 13, each of the medical records 1302 and 1304 includes a data field that identifies the patient, the personal mobile communication device 200a, and the home therapy machine 90. For example, records 1302 and 1304 include data fields relating to the patient identifier, the type of personal mobile communication device 200a, the type of home therapy machine 90, and the home therapy machine identifier (received via registration). The patient identifier may correspond to the PAC assigned to the patient. Records 1302 and 1304 may include additional fields relating to the patient's name, address, gender, date of birth, and the like. Records 1302 and 1304 may further include fields relating to the network address of the personal mobile communication device 200a and / or the home therapy machine 90. In some embodiments, the data access module 1106 of application 1020 uses the information in the device type field to determine how treatment and medical information should be presented and / or transmitted to the personal mobile communication device 200a. ..

Also, as shown in FIG. 13, medical records 1302 and 1304 include fields for treatment and medical information. The data acquisition module 1104 stores the treatment information received from the respective home therapy machines 90 in the records 1302 and 1304. In addition, the data acquisition module 1104 stores medical information received from the respective personal mobile communication devices 200a in the records 1302 and 1304. In some embodiments, the data fields are further subdivided into individual fields for the data type. For example, records 1302 and 1304 may include treatment information fields regarding the volume of infused fluid, the amount of extrafiltration (“UF”) removed from the patient, and / or treatment time. Records 1302 and 1304 may also include alerts or alarms generated during treatment and / or data fields for alarms or alerts determined on the clinician server 200b based on treatment information and / or medical information. Records 1302 and 1304 may further include medical information about the patient's weight and / or blood pressure recorded before, during, and / or after treatment.

Treatment and / or medical devices can be organized by treatment, date / time of occurrence, and / or date / time received. In some embodiments, medical records 1302 and 1304 may store communications from the patient. The communication may include a photo or video recorded by the personal mobile communication device 200a related to the treatment, or a question about the treatment. The communication may also include text messages, e-mails and the like regarding treatment assistance transmitted from the personal mobile communication device 200a. In addition, the communication may include information related to the request to change or modify the treatment from the personal mobile communication device 200a and / or the clinician device 152. In general, medical records 1302 and 1304 document information related to treatment outcomes and patient involvement with the clinician server 200b regarding treatment, as well as information to improve patient involvement in treatment. It is configured to be remembered.

The data received by the exemplary data acquisition module 1104 varies based on the source. For example, the treatment information received from the home therapy machine 90 is generally structured. In other words, the home therapy machine 90 is configured to transmit treatment information formatted for direct input to one or more data fields of a patient's medical record. In some embodiments, the home therapy machine 90 formats the message for transmission through the API of the data acquisition module 1104 (or otherwise 1) for inputting treatment information into the appropriate data field. Access one or more APIs). In contrast, the medical information recorded by the patient's personal mobile communication device 200a may initially be unstructured for inclusion in the patient's medical record. As described in more detail below, different techniques for processing and / or formatting medical information for submission to medical records include applications 1002 and / or clinician server 200b for personal mobile communication device 200a. Can be used by the data acquisition module 1104 of.

(1. Manual input of medical information to an application)
To receive structured information, the exemplary application 1002 of the personal mobile communication device 200a, in some embodiments, prompts to indicate medical information required for entry into a patient medical record by a patient. Is configured to display. The exemplary application 1002 may include routines or algorithms that define the fields that should be displayed to prompt for medical information from the patient. In some embodiments, the fields or screens on which the fields are displayed are arranged and / or ordered in relation to the medical fluid delivery treatment. The display of the field informs the patient about the medical information required for patient recording.

14 and 15 show a schematic diagram illustrating a user interface of application 1002 that allows a patient to enter medical information for transmission to the data acquisition module 1104. Specifically, the user interface 1400 of FIG. 14 prompts the patient for blood pressure information, while the user interface 1500 of FIG. 15 prompts the patient for medical fluid delivery information (eg, treatment information). It should be appreciated that application 1002 of the personal mobile communication device 200a may display other user interface screens that allow the patient to manually enter medical information. For example, application 1002 may display a user interface screen regarding blood glucose levels, patient body temperature, patient weight, and the like.

In some embodiments, the patient obtains other medical information wirelessly or records certain medical information via an image, but manually some of the medical information in the user interface 1400 or 1500. Can be entered. In these configurations, application 1002 may be configured to allow the patient to select an information input source. Patients may manually enter medical information after selecting a manual source from the menu of available data entry methods or by default.

After receiving the medical information manually entered by the patient, the exemplary application 1002 transmits the medical information to the data acquisition module 1104 for inclusion in the patient's medical record. Applications 1002 and user interfaces 1400 and 1500 are configured such that the data fields for receiving medical information are aligned with the data fields in one or more medical records. In some examples, the data field may correspond to one or more APIs in the data acquisition module 1104 for writing medical information directly into the designed data field of the patient's medical record. The application user interfaces 1400 and 1500 therefore prompt the patient for medical information in a structured manner so that identification or formatting of medical information is not or is not required.

In some embodiments, application 1002 may be configured to display user interfaces 1400 and 1500 at a designed time. For example, application 1002 may include a calendar that includes time / day for which treatment is scheduled. At a designed time prior to treatment (eg, 5 minutes, 15 minutes, 30 minutes, etc.), the exemplary application 1002 prompts the patient for blood pressure medical information by displaying the user interface 1400 on the personal mobile communication device 200a. It is composed of. The prompt informs the patient that a blood pressure measurement is needed before treatment begins. The patient accordingly uses the blood pressure monitor 104 to make blood pressure measurements. The patient then inputs the measured values into the user interface 1400 before treatment is initiated.

In the illustrated embodiment, the user interface 1400 includes a systolic blood pressure data field 1402, a diastolic blood pressure data field 1404, and a pulse data field 1406. The patient may select each data field 1402, 1404, or 1406 and have application 1002 display a text input feature for entering a value. The user interface 1400 includes a field 1408 that allows the patient to specify whether the blood pressure measurement was performed in a standing or sitting position. Further, the user interface 1400 includes a data field 1410 that allows the user to specify the date / time when the blood pressure measurement was performed.

In some examples, the patient may select any one of the fields 1402-1410 to receive further information about performing the corresponding measurement. For example, the patient may select the systolic blood pressure data field 1402, which causes application 1002 to display a tutorial instructing the patient how to perform a blood pressure measurement and identify systolic blood pressure measurements. Tutorials can include text, text / photos, audio recordings, animations, and / or videos. The tutorial can be stored locally as part of application 1002 or stored on the clinician server 200b for remote access or streaming.

The user interface 1500 of FIG. 15 is displayed by application 1002 when the patient is scheduled to perform manual replacement treatment and / or when the home therapy machine 90 is not registered with the clinician server 200b. It is configured as follows. Manual renal failure replacement treatment allows patients to connect a container of dialysis fluid to their abdominal cavity for a retention duration before allowing the used dialysis fluid to be drained without mechanical assistance. Request everything. With respect to manual treatment, patients need to enter their manual replacement medical information to allow their records to reflect accurate treatment information.

The exemplary application 1002 may also be configured to display the user interface 1500 when the patient has not registered the home therapy machine 90. During registration, the registration module 1102 may transmit a message to application 1002 indicating whether the home therapy machine 90 is registered. If the home therapy machine is not registered, application 1002 may be configured to display the user interface 1500 and / or other user interfaces in order to obtain treatment information that may normally be transmitted by the home therapy machine 90.

In the illustrated example, the user interface 1500 comprises progressing through treatment including a solution step, a drain step, a filling step, a UF or retention step, and an explanatory step. Application 1002 may display a separate user interface for each step prompting the patient to enter the corresponding treatment information or the required treatment information. The exemplary user interface 1500 corresponds to the UF stage, as indicated by the highlighted frame 1502. The user interface 1500 includes a discharge volume field 1504, a UF field 1506, and a fill volume field 1508. In the illustrated example, the user interface 1500 prompts the patient to enter the discharge volume into the data field 1504 during the discharge step and the fill volume into the data field 1508 during the fill step. The user interface 1500 may calculate a UF value for the UF data field 1506 or prompt the patient for a value.

Instead of displaying the user interfaces 1400 and 1500 at the designed time, application 1002 may instead display an alarm on the personal mobile communication device 200a. The alarm may identify the medical information required or may include a link to either the user interface 1400 or 1500. The alarm may include a pop-up window displayed by the personal mobile communication device 200a. The alarm may also include an icon that appears adjacent to the icon for application 1002 on the home screen of the personal mobile communication device 200a. Still in other embodiments, application 1002 may not notify the patient of the medical information required. Alternatively, application 1002 may allow the patient to navigate to the desired user interface for entering medical device data and / or treatment information.

In some embodiments, application 1002 may identify at least some of the data fields of one or more user interfaces as required for input, and the other data fields are optional with respect to input. be. Application 1002 may outline the required data field or show it otherwise graphically (eg, display a red frame around the systolic blood pressure data field 1402). Application 1002 may allow the personal mobile communication device 200a to display an alert message if the requested data field is not completed or is not completed by a certain time. In some embodiments, application 1002 may prevent the patient from navigating to another user interface until all requested fields have been populated with respect to the currently viewed user interface.

After the medical information is entered by the patient into one or more of interfaces 1400 and 1500, application 1002 transfers the medical information to the data acquisition module 1104 of the clinician server 200b for input to the patient's medical record. To transmit. Application 1002 is configured to transmit medical information after the patient fills in a data field in the user interface or otherwise presses a submit button on the interface. In other cases, application 1002 may transmit medical information at a predetermined time, such as before or after treatment.

(2. Wireless input embodiment of medical information to an application)
In some embodiments, the patient may choose to enter medical information wirelessly on his personal mobile communication device 200a. The medical information may be, for example, a Bluetooth® connection, a Zigbee® connection, a Z-Wave® connection, a wireless USB connection, a wireless RF connection, an NFC connection, an infrared connection, or any other suitable connection. It can be received by the personal mobile communication device 200a via wireless communication technology. In some cases, the patient may need to wirelessly pair the personal mobile communication device 200a with a medical device such as a blood pressure monitor 104 and / or a meter 106. In another embodiment, the patient activates a connected application (eg, an NFC application) that wirelessly reads medical information from a medical device.

In one example, the patient may pair his personal mobile communication device 200a with the blood pressure monitor 104. To enter blood pressure medical information into the user interface 1400 of FIG. 14, the user selects, for example, the systolic blood pressure data field 1402. Selection of field 1402 causes application 1002 to prompt the patient to select a data entry method (eg, manual, wireless, photo, etc.). After selecting a wireless option, application 1002 displays a menu of available wireless connection options and / or a list of paired Bluetooth® devices. The patient selects the blood pressure monitor 104 from the list, which causes a menu of available medical information to be displayed. The patient selects systolic blood pressure, which causes the systolic blood pressure value to be populated in the systolic blood pressure data field 1402. In some embodiments, application 1002 is configured to read medical information from the blood pressure monitor 104 after the device has been selected by the patient. Application 1002 may use data labels or metadata to determine fields 1402-1410 to which medical information from the blood pressure monitor 104 should be populated.

In some embodiments, application 1002 is configured to allow a patient to establish a permanent or semi-permanent connection with a medical device. During the setup operation, application 1002 prompts the patient to select a data field from user interface 1400. After selection, application 1002 prompts the patient to select a paired wireless medical device (and / or select a data type from the menu associated with the medical device). Patient selection, for example, configures application 1002 to automatically read medical information from the blood pressure monitor 104 as new medical information becomes available. In other words, application 1002 is configured to automatically wirelessly access a telemedicine device, read certain medical information, and populate one or more data fields. For example, after the patient uses the blood pressure monitor 104 to make a blood pressure measurement, the monitor 104 transmits a pin or status message to application 1002 indicating that new data is available. Alternatively, application 1002 may poll or otherwise pin to the blood pressure monitor 104 to determine if new data is available. Application 1002 then reads new data into one or more of the data fields 1402-1410 and automatically populates the user interface 1400. Application 1002 then sends medical information to the data acquisition module 1104 of the clinician server 200b to automatically update the patient's medical record.

(3. Image input embodiment of medical information to the application)
An exemplary application 1002 on a personal mobile communication device 200a is configured to allow a patient to enter medical information and / or treatment information by recording an image of the medical device or screen of the medical device. To. The personal mobile communication device 200a uses the camera 1004 to record one or more images. Application 1002 uses optical character recognition (“OCR”) to extract text from a recorded image. The extracted text is populated in one or more data fields of the user interface of application 1002. The use of images can reduce data entry errors from patients or clinicians.

In some embodiments, application 1002 uses a rule or data template to identify text from an image that may be selectable as relevant medical information for a data field. Otherwise, simply using the OCR feature makes all of the displayed text selectable. Therefore, the patient still needs to copy and paste the text from the image into the data field. By comparison, a rule or data template may classify or identify text from an image as a field, which allows easy or automatic selection by the patient for input to the data field of the user interface.

The data template or rule of application 1002 is configured to organize or otherwise decipher the text extracted from the image. Application 1002 determines or otherwise determines one or more data templates for establishing a context for the medical information, based, for example, the location of the medical information in the image and / or the markers / keywords contained within the medical information. select. To determine the data template, the exemplary application 1002 may prompt the patient to define the medical device type on which the image was recorded. In addition, or as an alternative, application 1002 allows the patient to select a medical device template. Still in other embodiments, the patient may first record an image of identifier 1012 (eg, an identifier image), which is used by application 1002 to determine the type, model, etc. of the corresponding medical device. To. Application 1002 then selects a data template or rule that corresponds to the type, model, screen, etc. of the medical device.

Data templates define or define data fields for certain medical information contained within an image. Generally, the image contains extracted text with medical information. In some cases, not all of the extracted medical information is needed or needed. Instead, only certain medical information in the recorded images is required for input to the user interface or data fields of patient medical records. The relevant medical information or related medical information is the medical device data identified or selected for input to the data field of the user interface of application 1002, or more generally for input to the patient's medical record. Or refers to medical information.

FIG. 16 illustrates a schematic diagram of a personal mobile communication device 200a for recording and processing images for medical information extraction, according to an exemplary embodiment of the present disclosure. The illustration of the personal mobile communication device 200a is exemplary and some of the blocks can be combined, further divided, or removed. In addition, in some embodiments, the personal mobile communication device 200a, when executed by the data processor 1602 (or more generally, processor 1016), causes application 1002 to process an image to extract medical information. It may include additional blocks such as memory 1018 for storing instructions.

The exemplary data processor 1602 may be configured to manage the acquisition of medical information from one or more images. Such management involves displaying one or more camera messages via screen 1002, which contains information prompting the clinician or patient (eg, operator) to record an image. offer. Alternatively, the data processor 1602 may initiate the image processing mode after the patient chooses to enter medical information in one or more data fields of application 1002 using the image input method. After selecting an image input method, the data processor 1602 is configured to obtain one or more images.

In some embodiments, the data processor 1602 causes the personal mobile communication device 200a to open a camera application, allowing the patient to record one or more images. The patient may select recorded images that should be further processed or discarded. The selected image is analyzed to identify the text (as medical information) for potential input to the data fields of one or more user interfaces of application 1002.

In another embodiment, the data processor 1602 may guide the patient through one or more steps to obtain an image. The data processor 1602 may execute a workflow or routine based on the data fields selected by the patient. For example, the data processor 1602 performs a blood pressure workflow for acquiring images from a blood pressure monitor based on the patient selecting the systolic blood pressure data field 1402.

In one example, the data processor 1602 of FIG. 16 is configured to display a camera message identifying the medical device to be recorded, the user interface window of the medical device, and / or the identifier on the medical device. The data processor 1602 may also display navigation messages that define the user interface window of the medical device for imaging. In addition, the data processor 1602 may display a reminder message if the image is not recorded within a predetermined time period (eg, 5 minutes). The message may include text providing the instruction and / or text identifying the intended target for imaging. The message may also include instructions on how to navigate to a user interface window on the medical device using the control interface of the medical device. The message may further include graphical elements such as a medical device on which an image should be recorded, a consumable item, an identifier 1012, and / or an exemplary illustration of a user interface window.

It should be appreciated that in some embodiments, the data processor 1602 does not display the message. Instead, the data processor 1602 responds to images recorded by the patient to determine relevant medical information. For example, upon receiving an instruction that an image has been recorded, the data processor 1602 activates a workflow in which application 1002 prompts the clinician to identify the medical device on which the image was recorded. The prompt may include a pull-down menu for available or common medical devices. In another example, the data processor 1602 uses one or more data templates or data labels to determine the extracted medical information that should be populated or written into the data fields of the user interface or medical records. And automatically identify medical information.

For recording images, the exemplary data processor 1602 and image processor 1604 (more generally, processor 1016) provide operation for application 1002 related to camera 1004. The patient provides instructions via the camera user interface 1606 (eg, a touch screen or button on the personal mobile communication device 200a) to record an image. The patient activates the camera user interface 1606, for example, when the camera is focused on the medical device user interface window or identifier 1012. The data processor 1602 receives the instruction and instructs the camera 1004 to record an image. The recorded image is transmitted from the camera 1004 to the image processor 1604. In addition, a copy of the image is displayed by the data processor 1602 on the display interface 1022 of the personal mobile communication device 200a.

In some embodiments, the data processor 1602 may cause an afterglow image illustrating an image to be recorded to appear on the display interface 1022. The afterglow image is provided on top of the stream of images provided by camera 1004 in preview mode. The purpose of the afterglow image is to provide the clinician or patient with assistance in ensuring that the image to be recorded contains the desired medical information and is recorded at an appropriate distance. For example, the data processor 1602 may display an afterglow image of a given identifier on a given medical device. The patient aligns the personal mobile communication device 200a so that the stream of the image with the identifier 1012a is positionedly aligned with the afterglow image. The patient may then record an image of identifier 1012a. In some cases, the data processor 1602 uses image analysis to determine the difference between the afterglow image and the stream of images. The data processor 1602 may display an instruction prompting the patient to move the personal mobile communication device 200a in a certain direction in order to reduce the determined difference. The data processor 1602 may determine when the difference is below a certain threshold and indicate that the images are aligned. When the images are substantially aligned, the data processor 1602 provides graphical instructions on the display interface 1022 indicating that the images can be recorded, or automatically without input from the patient. Can be recorded.

The data processor 1602 may provide a prompt for the patient to accept the image. After receiving the acceptance instructions via the camera user interface 1606, the image processor 1604 may analyze the image to identify or otherwise extract the text. In some cases, the data processor 1602 may not prompt the clinician to accept the image. Alternatively, the patient may provide instructions for deleting the image via the camera user interface 1606. The image processor 1604 performs an analysis to identify the text until the image is deleted.

To identify the text, the image processor 1604 uses, for example, OCR. In addition, the image processor 1604 may determine the location or position of the text with respect to the center or origin of the image. In some cases, the image processor 1604 may assign two-dimensional coordinates to each character or group of characters. The position text information can be stored in the image fill of the image as metadata. The image processor 1604 may also use the clock of the personal mobile communication device 200a to attach the date / time (corresponding to the time when the image was recorded) to the metadata associated with the image.

In addition to performing OCR to identify text, the image processor 1604 may also be configured to use image analysis to identify patients, medical devices, and / or consumable items. For example, the image processor 1604 may access a library of medical device images to identify medical devices in the image. In this example, the image processor 104 may use an image matching routine to determine the match. Such a comparison may be made on behalf of the medical device having the identifier 1012. Image processor 1604 may use similar routines and / or algorithms for identifying consumable item 1006.

The exemplary data processor 1602 is configured to decode the identifier 1012 to determine the type of medical device for the consumable item. Decoding may include correlating the position and thickness of lines and / or rectangles with related medical information. The coded lines and rectangles can correspond to a series of letters and / or numbers. For example, the data processor 1602 may use the line or rectangle of identifier 1012 to determine the device model number, medical device type, asset code, and the like. The decoded identifier 1012 may provide relevant medical information for input to one or more data fields of the user interface of application 1002. In addition, or as an alternative, the decoded identifier is used by the data processor 1602 to select a workflow for obtaining images from a medical device or consumable and / or to determine a data template. obtain.

The exemplary image processor 1604 of FIG. 16 transmits an image with extracted or otherwise identified text and / or medical information to the data processor 1602. The exemplary data processor 1602 uses, for example, one or more data templates from the data template database 1608 to identify relevant medical information from the extracted text. In some examples, the data processor 1602 receives data templates from the clinician server 200b, which may then be stored in database 1608. In another example, the data processor 1602 maintains database 1608 with a data template.

FIG. 17 illustrates a schematic diagram of a data template 1700 according to an exemplary embodiment of the present disclosure. The exemplary data template 1700 is used by the image processor 1604 (eg, application 1002) to identify the extracted text as relevant medical information. Generally, the screen of a medical device displays medical information. Some of the information is relevant for inclusion within the data fields of the user interface of application 1002. Others of the data may or may not be very relevant. Moreover, depending on the model of the medical device, the medical information may be in different locations or have different labels. The data template 1700 is configured to define the location and name of relevant medical information about a particular home therapy machine 90.

The data template 1700 is stored in database 1608 along with a plurality of other data templates for different types and / or models of medical devices and / or consumable items. After receiving the medical device identifier 1012 (or the patient's definition of the medical device or data field), the image processor 1604 selects the corresponding data template 1700. In addition, or as an alternative, the image processor 1604 may use image processing to select the data template that best matches the recorded image, for example using information markers or text positions.

The exemplary data template 1700 of FIG. 17 includes device data (or text) fields 1702, 1704, 1706, and 1708, which define where certain medical information is located on a particular user interface window of the medical device. do. In some examples, the data template 1700 is graphical, whereby image analysis is performed to align fields 1702-1708 with the extracted text in the image. In another example, the data template 1700 includes a file (or other data structure) having coordinates or positions for each of the device data fields 1702-1708 with respect to the origin. The image processor 1604 identifies the origin in the image with the extracted text and identifies the text for each of the data fields 1702-1708 based on a substantial match to a location within the data template 1700. In some examples, the image processor 1604 may scale the image to match the size or coordinate space of the data template 1700.

Some of the illustrated data fields 1702-1708 may include indicator text in addition to coordinates and / or location. For example, the device data field 1702 comprises the marker text "extreme filtration window", while the device data field 1704a comprises the indicator text "UF volume". The image processor 1604 matches the indicator text to similar text extracted from the image. In some cases, matching between marker texts is used exclusively to identify device data fields rather than using location or image analysis.

Matches between indicator texts, including indicator texts for irrelevant device data fields, can be used to ensure that the image is from the correct window or screen of the medical device. For example, the image processor 1604 may match the marker text "extreme filtration window" to the corresponding extracted text in a relatively co-located image of the recorded image. Matching confirms that the image was recorded from the extrafiltration window of the renal failure therapy medical device. However, the extracted text is not relevant medical information regarding the patient's medical record. If the marker text does not match the extracted text, the image processor 1604 may display a message prompting the patient to record an image of the extrafiltration window of the renal failure therapy medical device.

The indicator text associated with the device data fields 1706 and 1708 can be used to ensure that the recorded image is current or has been recorded within a given time period. For example, some windows on a medical device display the current date and time. This information can be extracted by the image processor 1604 and identified using the device data fields 1706 and 1708. The image processor 1604 compares the extracted date / time with the date / time rule or limit associated with the device data field 1706-1708 to determine if the recorded image is current. .. For example, the image processor 1604 may use the image processor 1604 if the dates do not match, or if the time is within a predetermined threshold of the current time on the personal mobile communication device 200a (eg, 5 minutes, 15 minutes, 60 minutes, 3 hours, etc.). If not, it may be determined that another image is required to be recorded.

The exemplary device data fields 1704a and 1704b of FIG. 17 are used by application 1002 to identify relevant medical information. In some cases, application 1002 may display flags or metadata indicating that the device data fields 1704a and 1704b are associated with selected data fields in the user interface (eg, user interface 1400 or 1500). By comparison, the device data fields 1702, 1706, and 1708 may include flags or metadata indicating that the corresponding extracted data is not relevant. In the example illustrated in FIG. 17, the image processor 1604 uses the indicator text in data field 1704a to find the corresponding extracted text in the image. The image processor 1604 then uses the positional relationship between the device data fields 1704a and 1704b, or between the text value markers, to identify the medical information extracted from the image corresponding to the numerical value of the critical filtration volume. The image processor 1604 copies the extracted medical information associated with field 1704b from the image, for example, for inputting into the systolic blood pressure data field 1402 of FIG.

As discussed above in connection with FIG. 17, the data processor 1602 of FIG. 16 determines the known location of the text and text markers in the image to determine the extracted text corresponding to the relevant medical information. Relationships can be used. In some embodiments, the data processor 1602 selects a data template based on the model or type of medical device and / or consumable item instructions. Instructions are determined from previous images of identifier 1012, received from the patient via camera user interface 1606, and / or defined through selection of user interface data fields for application 1002 to which medical information should be populated. Can be done. In another example, the data processor 1602 compares the data template in database 1608 with an image with extracted text to find a match. In these other examples, the data processor 1602 uses the text indicator and the position of the text between the image and the data template to determine the match.

The exemplary data processor 1602 is configured to identify relevant medical information and then write or otherwise populate one or more data fields in the user interface of application 1002. In some embodiments, the data processor 1602 is configured to use a data template to automatically populate the data fields of the user interface of application 1002. To automatically populate medical information, the data processor 1602 populates the text, signs, and / or metadata associated with the fields in the data template with the text, signs, and metadata in one or more user interfaces of application 1002. , And / or compare with other data field information. If at least some of the text, markers, and / or metadata match, the data processor 1602 identifies some text (eg, a number) that corresponds to the matching field in the data template. The identified text is written to the corresponding matching data field in the user interface of application 1002.

In another embodiment, the data processor 1602 is configured to select one or more fields in the data template and prompt the patient to populate one or more data fields in the user interface of application 1002. To. FIG. 18 shows a schematic diagram illustrating a patient populating data fields 1402-1406 of user interface 1400 according to an exemplary embodiment of the present disclosure. In the illustrated example, the user interface 1400 is opened on the personal mobile communication device 200a. To enter medical information in data fields 1402-1406, the patient selects each of the data fields continuously or together. For each selection, application 1002 prompts the patient how the data should be entered. After the patient has selected a photo input method, application 1002 opens a camera application and allows the patient to record an image 1800 of the screen of the blood pressure monitor 104 using the personal mobile communication device 200a. In some embodiments, application 1002 may display text or graphics to assist the patient in obtaining an image, as described above.

After the image 1800 is recorded, application 1002 performs an OCR operation to extract the text. Application 1002 then determines the data template 1801 corresponding to the extracted text. In some embodiments, application 1002 matches the location of the text and / or indicator in the image to the location of the text and / or indicator in the data template in order to find a matching data template. In another example, the patient may prescribe instructions for the blood pressure monitor 104, which allows application 1002 to find the corresponding data template 1801. In yet another example, application 1002 may first prompt the patient to record an image of identifier 1012a of blood pressure monitor 104. The data from the identifier is used by application 1002 to select a data template. Regardless of how the data template 1801 is identified, the application 1002 applies the data template 1801 to the extracted text in the image 1800. This process involves the application 1002 identifying similar groups or fields of text. In some cases, application 1002 may identify similar groups or fields of text based on the spacing between letters and / or words.

In the illustrated example of FIG. 18, application 1002 provides fields 1802, 1804a, 1804b, 1806, 1808, and 1810 for different sets of text. The patient selects a field in which the data should be populated in the selected data field of user interface 1400. For example, to populate the systolic blood pressure data field 1402, the patient selects field 1804a. Patient selection causes application 1002 to copy at least a portion of the data from field 1804a into data field 1402. The data field 1402 may include a rule that specifies that only integer integers can be received. Application 1002 reads text about a numeric integer (ie, "145") from the selected field 1804a. Application 1002 then populates the systolic blood pressure data field 1402 with an integer of the identified number. The patient may use image 1800 to continue with respect to other fields 1404-1410 of user interface 1400. In each case, the patient may choose to enter manually, enter wirelessly, or enter the data via an image. When a second image is required (eg, prompted by application 1002 or determined by the patient), application 1002 allows the patient to record and view multiple images. Application 1002 applies the appropriate data template to each of the recorded images. Application 1002 therefore allows the patient to enter information into the user interface 1400 using one or more recorded images, as if the patient manually entered the value.

In some embodiments, the application 1002, more specifically the data processor 1602, is used by the user to ensure that the values are within a predetermined range and / or are of a defined type. Perform a check on the selected extracted data. Application 1002 may perform similar checks on data manually entered by the patient or received wirelessly from a medical device. Each data template and / or data field in the user interface may contain metadata or rules for a field that provide a threshold or acceptable range of values. For example, metadata or rules regarding weight data fields may specify that a given acceptable range of values is between 20 kg and 200 kg. For values outside the predetermined range, application 1002 may display an error on display interface 1022 or prompt the patient to record another image or correct the value.

FIG. 19 illustrates a flow diagram of an exemplary procedure 1900 for inputting medical information from an image using application 1002 of a personal mobile communication device 200a according to an exemplary embodiment of the present disclosure. Although procedure 1900 is described with reference to the flow diagram illustrated in FIG. 19, it should be appreciated that many other methods of performing the steps associated with procedure 1900 may also be used. For example, many orders of blocks can be changed, one block can be combined with another, and many of the described blocks can be arbitrary. In addition, the exemplary procedure 1900 may include a voluntary block for prompting the patient to record a screen and / or an image of identifier 1012 on a medical device.

An exemplary procedure 1900, in one embodiment, uses a processor 1016 such that application 1002 is called onto the personal mobile communication device 200a to establish a wired and / or wireless connection with the clinician server 200b (block 1902). Is started when it works. Establishing a connection may include transmitting and / or receiving 1903 of one or more messages, which may include, for example, a device for accessing and / or writing a patient's medical record. Provides address, patient identifier, device identifier, network address, and / or protocol information. After opening application 1002, the patient navigates or otherwise accesses the user interface (eg, user interface 1400 or 1500 in FIGS. 14 and 15) to enter medical information (block 1904). ).

Prior to block 1906, the patient uses application 1002, selects a data field, and selects that medical information should be provided via photo input. At block 1906, the personal mobile communication device 200a records images 1907 of medical devices, consumables, patients and the like. The image may include a medical device identifier and / or screen. The personal mobile communication device 200a then determines or identifies the text in the recorded image (block 1908). For example, the personal mobile communication device 200a may perform an OCR routine on an image. In cases where the image contains a barcode and / or a QR code®, the personal mobile communication device 200a decodes the barcode and / or the QR code®. The captured or coded data is converted to text or US standard code for information exchange ("ASCII") characters. In some embodiments, the personal mobile communication device 200a may also determine a data field for the identified text (block 1910). Data fields can be determined using, for example, data templates. As described above in connection with FIGS. 17 and 18, the data template defines the location of certain text and / or behaviorally data fields on top of the identified text in the recorded image. May specify a textual sign used to install. In some cases, the data field and / or data template may be selected by the patient and / or determined from the medical device identifier 1012. Alternatively, instead of using a template, Procedure 1900 may instead provide instructions that the recently recorded image has relevant medical information for extraction, selection, and / or transfer.

The exemplary procedure 1900, in one embodiment, continues by determining if there are additional images to be recorded (decision block 1912). In one example, procedure 1900 may access a list of images that need to be recorded for a given therapy or treatment. Procedure 1900 guides the patient through a sequence for acquiring all required images via the personal mobile communication device 200a, or medical information determined to be required or missing. May provide a prompt to retrieve an image containing. In other cases, the patient may determine the required image. If additional images should be recorded, procedure 1900 returns to block 1906.

As determined in decision block 1912, if no additional images are needed, the patient initiates the process of populating the medical information associated with the data fields of the user interface. The process in the illustrated embodiment comprises allowing the patient to select an image to which the relevant medical information should be transferred. The image selection causes the personal mobile communication device 200a to display the image on the display interface 1022 (block 1914). It should be understood that the selected image contains the identified text and optionally the data fields. The patient may also specify the data field (or location within the data field) of the user interface from which the data should be populated.

The personal mobile communication device 200a receives a selection of relevant medical information and / or a data field with relevant medical information for population into the designed data field of the user interface of application 1002. The selection may be performed by the patient pressing the area of the touch screen 1002 of the personal mobile communication device 200a corresponding to the medical information to be populated. Selection of relevant medical information and / or fields, in certain embodiments, causes the personal mobile communication device 200a to automatically populate at least a portion of the selected text (block 1916).

After the selected text has been populated, the personal mobile communication device 200a determines whether additional relevant medical information should be populated based on the selection of additional data fields in the user interface. (Decision block 1918). In some examples, the personal mobile communication device 200a operates a sequence or routine that provides a prompt for the patient to select the appropriate text and / or image to populate the data field. If additional relevant medical information is present, as determined in decision block 1918, procedure 1900 returns to blocks 1914-1916 and the patient receives an image and / or related medical information for data field entry. Prescribe. As determined in decision block 1918, the exemplary procedure 1900 ends in the absence of any additional relevant medical information for input.

(4. Image / text attachment application embodiment)
An exemplary application 1002 and a clinician server 200b in some embodiments are configured to allow a patient to provide an image or text as an attachment or an addendum to their medical record. In the above section, application 1002 provides user interface data fields as prompts for the desired information. However, in some cases, the patient or clinician may wish to provide additional information. In addition, or as an alternative, one or more user interfaces in Application 1002 include data fields for free text input, prompts for patients to enter text (eg, "How are you feeling today?"), Or it may include features to allow the photo or image to be incorporated as part of the recording. For example, the user interface 1400 may include a photo icon adjacent to a prompt for an image of a fluid connection to the patient's abdomen, which, when selected, opens a camera application and allows the patient to image for transmission along with medical information. Allows you to attach. The image may be stored in a designed field in the appropriate patient medical record.

The exemplary application 1002 on the personal mobile communication device 200a is configured to accept images and / or text provided by the patient. In certain embodiments, application 1002 is configured to allow the patient to select text or photo input. If the patient chooses text input, application 1002 displays a text box. The patient enters the information in a text box, which is stored by application 1002. Application 1002 may then transmit the information in one or more messages to the clinician server 200b. Application 1020 on the clinician server 200b determines the appropriate patient medical record in database 1010 and finds a "memo" or free text field. Application 1020 stores the patient-provided text in the field. In some cases, application 1020 may include time / date stamps as well as the text entered. This information provides the clinician with additional information from the patient, including feedback on treatment.

FIG. 20 shows an example of a user interface 2000 that can be displayed by application 1002 on a personal mobile communication device 200a that allows a patient to provide recorded images according to an exemplary embodiment of the present disclosure. The exemplary user interface 2000 includes an image title field 2002 that may be editable by the patient. User interface 2000 also includes a preview of one or more recorded images 2004 or recorded images. Application 1002 is configured to allow the patient to browse the gallery folder of recorded images and select the images to be transmitted. The date field 2006 and the time field 2008 provide information in the user interface 2000 indicating the date / time when the displayed image was recorded. The patient may select the "trash box" button for discarding the image 2004 or the "upload" button for transmitting the image 2004 from the application 1002 to the clinician server 200b. The exemplary photocapture features of Application 1002 allow the patient to document fluid line connectivity with the home therapy machine 90 or the physiological conditions associated with the treatment. Application 1020 on the clinician server 200b is configured to attach or otherwise link the received image 2004 to the patient's medical record.

(5. Manual / wireless / image input embodiment of medical information via text)
In some embodiments, the personal mobile communication device 200a of FIG. 10-12 may not be able to install or operate application 1002, or the patient decides not to install application 1002. obtain. However, the clinician server 200b still registers the personal mobile communication device 200a during the registration process. Instead of receiving medical information via application 1002, the data acquisition module 1104 of the clinician server 200b has a routine or algorithm prompting the patient for medical information via the personal mobile communication device 200a, or otherwise. To determine what should be done to get it. The exemplary data acquisition module 1104 may determine by reading the patient's registration file and / or medical record that the personal mobile communication device 200a is registered but application 1002 is not installed.

In some embodiments, the data acquisition module 1104 is configured to acquire medical information from a patient through one or more text messages. For example, at a designed time corresponding to the time of prescribed treatment, the data acquisition module 1104 uses the enrolled personal mobile communication device 200a to urge the patient to respond with medical information. Can transmit text messages. In other cases, the data acquisition module 1104 is configured to respond to text from a patient in order to initiate a sequence or routine for obtaining medical information. In other cases, the patient may send a text message with medical information and / or images to the data acquisition module without a prompt message.

The exemplary data acquisition module 1104 of FIG. 11 is configured to format or otherwise structure the received information for input to one or more data fields of the patient's medical record. In general, medical information received from text messages is unstructured. In other words, the text message does not provide a clear correlation or reference to the designed field of the patient's medical record. Instead, the data acquisition module 1104 is configured to determine the appropriate field for medical information received within the text message.

In some embodiments, the data acquisition module 1104 uses the context of a text message received from the personal mobile communication device 200a to determine the data field. For example, the patient may send a message containing the text "systolic blood pressure 145". The data acquisition module 1104 compares at least a portion of the text (eg, one or more words in a string) with field data indicators, keywords, and / or metadata. If at least some of the words match, the data acquisition module 1104 identifies a number in the content of the text message and places the identified number in the data field of the patient's medical record corresponding to the matching text. It is configured to write to. In some embodiments, the data acquisition module 1104 may compare the value to an acceptable range of values before writing the value. If the value is out of the acceptable range, the data acquisition module 1104 may transmit a message indicating an error or a message prompting the patient to re-enter the value to the personal mobile communication device 200a.

In these embodiments, the data acquisition module 1104 may be configured to send a follow-up text to the patient if the text from the received text message cannot be properly placed in the data field. For example, the data acquisition module 1104 may receive a message with a text comprising "blood pressure 145". Based on the matching text, the data acquisition module 1104 determines that the message can correspond to a "systolic" or "diastolic" blood pressure data field. Accordingly, the data acquisition module 1104 transmits a message with a text asking the patient whether the value is "systolic" or "diastolic" to the personal mobile communication device 200a.

In another embodiment, the data acquisition module 1104 prompts the patient through a sequence of messages (which may be defined by a routine or algorithm) to provide certain medical information. The sequence sequence is known or defined and corresponds to a data field in the medical record. Therefore, the data acquisition module 1104 automatically determines that the response to a prompt corresponds to the data field of the medical record associated with the prompt. For example, the data acquisition module 1104 transmits a text message prompting the patient regarding "systolic blood pressure measurement". The data acquisition module 1104 determines that the response to the text contains a value for "systolic blood pressure measurement". The data acquisition module 1104 may analyze the received message to identify the numerical value from among other texts and / or to compare the value with an acceptable range. After confirming that the patient has provided an acceptable response with medical information, the data acquisition module 1104 determines a subsequent message to be sent to the personal mobile communication device 200a based on the sequence of messages.

Instead of receiving a message with text, the data acquisition module 1104 may also receive a message with a photo attachment. Similar to the process described above in connection with FIGS. 16-19, the data acquisition module 1104 processes images, extracts text, and identifies relevant medical device data for one or more data fields of medical records. It is configured to do. Further, although the above disclosure illustrates the use of text messages, the data acquisition module 1104 additionally or as an alternative via other communication media such as email, instant or web-based messages, social media posts, etc. Receive medical information and / or photos.

FIG. 21 shows a schematic representation of the patient medical template 2100 according to an exemplary embodiment of the present disclosure, wherein the patient medical template 2100 is data from the clinician server 200b for populating the data field of the patient's medical record. Can be used by acquisition module 1104. The fields in template 2100 may correspond to, or otherwise be linked to, a data field in the patient's medical record. In other embodiments, a copy of the completed template 2100 may be stored in the medical record or may be stored as the medical record itself. In some embodiments, the patient medical template 2100 may be part of or otherwise integrated with the patient's medical record.

The exemplary template 2100 includes predetermined fields 2102, 2104, 2106, 2108, 2110, 2112, 2114, 2116, 2118, and 2120 that correspond to renal failure therapy treatment (“RFT”). The exemplary data acquisition processor 1104 may select template 2100 based on the treatment prescribed for the patient. Although the RFT template 2100 is illustrated, the exemplary data acquisition module 1104 may select other templates specifically configured for pre-treatment data acquisition, post-treatment data acquisition, and the like. For example, a pretreatment acquisition template may include data fields for blood pressure, pulse, and body weight.

It should be appreciated that in other embodiments, the patient medical template 2100 may include additional or fewer fields. For example, template 2100 may additionally include data fields for pre-treatment patient weight and post-treatment patient weight, patient glucose levels, and / or patient date of birth. In another example, the template 2100 has a filling rate, residence time, drainage or fluid removal rate, blood flow rate, outflow rate, ultrafiltration removal rate, dialysate removal rate, total injected dialysate, dialysate flow rate, Pre-replacement flow rate, post-replacement flow rate, patient weight balance, return pressure, signs of excess patient fluid, filtration rate, remaining time, dialysate concentration, dialysate name, patient identifier, room identifier, treatment area identifier, data generated It may include time stamps indicating when it was done, alarm conditions, alert conditions, and / or fields related to the event.

In some embodiments, the data acquisition module 1104 is configured to select template 2100 based on a prompt from the patient. For example, the patient may send a message containing the text "manual exchange" to the data acquisition module 1104. In response, the data acquisition module 1104 identifies and selects template 2100 for manual replacement. In another example, the patient may send a message containing the text "before treatment" or "begin treatment" to the data acquisition module 1104 via the personal mobile communication device 200a. In response, the data acquisition module 1104 identifies and selects a template for obtaining medical information needed before treatment is initiated.

In the illustrated example of FIG. 21, the exemplary data fields are field 2102 for patient name, field 2104 for patient identifier, field 2106 for patient weight, field 2108 for patient blood pressure, field 2110 for treatment date, removal. Includes field 2112 for the amount of UF given, field 2114 for the total fluid volume provided to the patient, field 2116 for glucose levels, field 2118 for the therapeutic prescription identifier, and field 2120 for the disposable cassette identifier. In the case where the kidney therapy machine 90 is registered on the clinician server 200b, the data acquisition module 1104 can remove at least field 2112-2120 as such information is already provided by the machine 90 ( Or select a separate template with fields 2112-2120 omitted). However, field 2112-2180 can be used in the template if the patient is reporting a manual replacement. In addition, template 2100 may omit fields 2102 and 2104 based on at least a portion of the patient information already registered.

The exemplary data fields of the patient medical template 2100 can be populated from one or more different sources of medical information, including device information, patient information, and / or consumable item information. For example, the patient name field 2102 and the patient identifier field 2104 may be populated with data from images recorded by the personal mobile communication device 200a of the patient identifier 1012 (or identifier 1012 worn by the patient). The blood pressure field 2108 may be populated with data from an image recorded by the personal mobile communication device 200a on the screen of the blood pressure monitor 104, while the weight field 2106 is an image recorded by the personal mobile communication device 200a on the screen of the measuring instrument 106. Data can be input from. The date field 2110, the removed UF field 2112, and the fluid filling field 2114 may be populated from images recorded by the personal mobile communication device 200a on the screen of the home therapy machine 90 (indicating a treatment status window). Similarly, the glucose level field 2116 may be populated with data from an image recorded by the personal mobile communication device 200a on the screen of the home therapy machine 90 (indicating a setting window), and the prescription identifier field 2118 may be the home therapy machine 90. Data can be input from an image recorded by the personal mobile communication device 200a on the screen (indicating a prescription window). Finally, the cassette identifier field 2120 may be populated with data from an image recorded by the personal mobile communication device 200a of identifier 1008 of the disposable cassette consumable item 1006. As discussed above, the data acquisition module 1104 may receive one or more messages with text relating to field 2102-2120 instead of receiving an image containing medical information.

The patient medical template 2100 illustrated in FIG. 21 is stored on the clinician database 1010 and configured to be accessed by the clinician server 200b illustrated in FIGS. 10 and 11. Upon receiving a request to populate the template for the patient, the clinician server 200b is configured to copy or instantiate the template 2100. The medical information received from the personal mobile communication device 200a is entered by the data acquisition module 1104 into a copy of template 2100 or the appropriate data field 2102-2120 of the instance. Upon completion, the copy or instance is stored in the repository of the clinician database 1010 as a medical record of the patient.

In some embodiments, the data acquisition module 1104 operates routine 2150 in conjunction with or as an alternative to the exemplary patient medical template 2100. In some embodiments, the routine 2150 may be programmed as metadata or computer executable code for each data field 2102-2120. In another example, the routine 2150 may be stored in the clinician database 1010 in connection with the patient medical template 2100. Moreover, in these other examples, the selection of template 2100 causes routine 2150 to be executed. An exemplary routine 2150 includes routine modules 2152-2164, which provide an association between data fields 2102-2120 and the corresponding medical device, identifier 1012, and / or consumable item 1006.

At least some of the routine modules 2152-2164 may or may not be associated with a data template (eg, data template 1700 in FIG. 17). The data acquisition module 1104 is configured to access the data template for the corresponding routine module 2152-2164 when the patient provides an image and / or text in the message. For example, while executing the routine module 2156 for blood pressure, the data acquisition module 1104 transmits a message prompting the personal mobile communication device 200a regarding "systolic blood pressure measurement". The patient responds with a text message containing an image of the screen or dial of the blood pressure monitor 104. The data acquisition module 1104 is configured to correspond to or access a data template that corresponds to or is referenced by the routine module 1156 for blood pressure measurement. The data acquisition module 1104 then applies a data template and uses the procedure described above in connection with FIGS. 16-19 to extract text from the image and populate the blood pressure data field 2108 of template 2100. Identify relevant systolic blood pressure medical information for.

The exemplary routine 2150 may be configured to be initiated on the basis of one or more messages received by the data acquisition module 1104 at the time of request from the patient. For example, the data acquisition module 1104 may receive a message with text containing "begin", "begin", and / or "pre-treatment". The reception of the message causes the data acquisition module 1104 to determine and initiate a routine 2150 for inputting data into the data field 2102-2120 of the template 2100. In another example, the data acquisition module 1104 transmits a first message defined by routine 2150 to the patient at a predetermined time for treatment. The data acquisition module 1104 receives a response message with appropriate medical information from the personal mobile communication device 200a, and then continuously transmits the message specified by the routine 2150. In this way, the data acquisition module 1104 controls the acquisition of medical information from the patient according to a predetermined sequence. The data acquisition module 1104 is defined by routine 2150 until an appropriate response message is received from the personal mobile communication device 200a (and medical information is populated into the designated data field 2102-2120 of template 2100). The next message may not be transmitted in the sequence.

In the illustrated example, the patient band module 2152 may include metadata or preformatted messages instructing the patient to record an image of the patient's wristband. The patient band module 2152 may also include a text validation check to ensure that the received medical information meets the textual requirements for the patient's name and / or patient identifier. For example, the patient band module 2152 may exclude or discard medical information about the patient's name, including numbers.

The weighing module 2154 may include the identifier 1012c of the scale 106 of FIG. 10 and metadata or pre-formatted messages instructing the patient to record an image of the screen. The weighing module 2154 may also include a character verification check to ensure that the medical information received is within acceptable range of values and / or of the correct unit type. In some cases, the weigh scale module 2154 may use the medical information from the identifier 1012c to confirm that the medical information from the screen of the meter 106 is patient weight medical information. In other cases, the medical information from identifier 1012c is used, for example, to select a data template based on the model or type of weigh scale 106. The data template is used by the data acquisition module 1104 to identify the relevant weight scale medical information extracted from the screen image of the scale 106.

The blood pressure module 2156 is similar to the weigh scale module 2154 with respect to the blood pressure monitor 104. The renal failure therapy (“RFT”) module 2158-2162 is also similar to the weigh scale module 2154. However, the plurality of modules 2158-2162 are used for the home therapy machine 90 (or manual replacement) for each of the different windows where medical information is needed. For example, module 2158 provides a message to obtain the identifier 1012 of the home therapy machine 90 and an image of the first window showing the treatment status window, while module 2160 provides an image of the settings window of the home therapy machine 90. Providing one or more messages to obtain, module 2162 provides one or more messages to obtain an image of the prescription window of the home therapy machine 90.

The cassette module 2164 is a metadata or preformatted message instructing the clinician or patient to record an identifier 1008, a disposable cassette consumable item 1006, and / or an image of a marker on the packaging or the cassette consumable itself. May include. It should be appreciated that routine 2150 may include additional modules if the patient medical template 2100 contains additional data fields, or may contain fewer modules if template 2100 contains fewer fields.

When medical information is received using routine 2150, the data acquisition module 1104 of application 1020 will have the data within acceptable limits, correctly formatted, and / or in the appropriate units. Use data validation checks to ensure that they are. In some cases, the modules of Routine 2150 may include conversion or format instructions, which prepare medical information for inclusion in the respective fields of Template 2100 and / or patient medical records. , Used by the data acquisition module 1104. When the data is in the appropriate format and unit, the data acquisition module 1104 writes the medical information in the respective fields of the template 2100 and / or the patient's medical record.

In an alternative embodiment, the patient medical template 2100 may not have an associated routine. Instead, the data acquisition module 1104 of FIG. 11 is configured to read, for example, the data fields 2102-2120 of the patient medical template 2100 to determine incomplete data fields. In these alternative embodiments, the data acquisition module 1104 identifies the missing data and transmits one or more messages to the personal mobile communication device 200a to prompt the patient for the missing data.

To populate a data field, the data acquisition module 1104, in some embodiments, reads the name (and any corresponding metadata) of the data field 2102-2120 and prompts the recording of an image. Can be created and sent to the patient. In one example, the weight data field 2106 contains metadata that identifies the weight scale as the associated medical device. The data acquisition module 1104 determines that the data field 2106 is blank and commands the patient of the personal mobile communication device 200a to read the corresponding metadata and record an image of the screen of the weigh scale. To construct. In the illustrated embodiment, the data acquisition module 1104 proceeds continuously through template 2100 (or patient medical record), searches for blank data fields, and appropriately displays a message by the personal mobile communication device 200a. Medical information can be requested from the patient through. Alternatively, the data acquisition module 1104 may proceed through template 2100 according to a predetermined order or sequence. For example, the data acquisition module 1104 first searches the data fields associated with the patient's wristband, followed by data fields for the weigh scale medical device, data fields for the blood pressure medical device, and data for the renal failure therapy medical device. You can search the field.

FIG. 22 is a schematic diagram of the data acquisition module 1104 of the clinician server 200b of FIG. 11 according to an exemplary embodiment of the present disclosure. It should be appreciated that the illustration of the data acquisition module 1104 is exemplary and some of the blocks can be combined, further divided or removed. In addition, in some embodiments, the data acquisition module 1104 may include additional blocks such as blocks relating to the user interface.

The exemplary data acquisition module 1104 (more generally, the clinician server 200b) includes an interface 2202 that provides connectivity with the personal mobile communication device 200a. Interface 2202 may include, for example, an internet port or connection. Interface 2202, in one embodiment, is configured to receive a message from the personal mobile communication device 200a and convert it into a compatible format for internal processing. For example, interface 2202 may convert SMS or text messages to HL7 or ASCII format. The exemplary interface 2202 is also configured to format or transform the message for transmission to the personal mobile communication device 200a. In some cases, interface 2202 may encrypt the message for transmission and / or decrypt the received message.

The exemplary data acquisition module 1104 includes a template processor 2204 configured to manage the writing or input of medical information from the personal mobile communication device 200a to the patient medical template 2100 or record. For example, upon request from a patient or clinician, or automatically, the template processor 2204 selects a template from the patient medical template database 2206. The selected template (eg, template 2100 in FIG. 21), if available or configured, to run a routine (eg, routine 2150) and obtain medical information from the personal mobile communication device 200a. Used by the template processor 2204.

The exemplary template processor 2204 is configured to identify messages from modules of routines (eg, routines 2150) for transmission to the personal mobile communication device 200a. In some cases, the message may be transmitted in a predetermined sequence to direct or guide the clinician or patient through the process of populating the patient medical template. For example, the template processor 2204 may read module 2156 of routine 2150 of FIG. 21 and determine that a message prompting the patient to record an image of identifier 1012c of instrument 106 should be transmitted. Template processor 2204 is configured to wait until medical information associated with identifier 1012c is received (to populate data field 2106 of FIG. 21) before identifying a message from routine module 2156 to be transmitted. Can be done. In another example, the template processor 2204 selects a message for transmission based on the message received from the personal mobile communication device 200a. For example, processor 2204 may receive medical information associated with identifier 1012c of weigh scale 106. In response to the medical information received, the template processor 2204 may determine that module 2154 corresponds to the received data, and accordingly the patient is asked to record an image of the screen of the weigh scale 104. Select the message you want to prompt. As illustrated in FIG. 22, the personal mobile communication device 200a displays a text message from the template processor 2204 instructing the patient to record an image of screen 2220 of the measuring instrument 106.

In addition to sending messages, the template processor 2204 may be configured to select a data template. The data template is stored in the data template database 2208 in the illustrated embodiment. Template processor 2204 selects a data template based on the type or model of medical device indicated in the medical information corresponding to identifier 1012. In some cases, the patient may define the model and / or type of medical device type to the template processor 2204 via a message. Further, as discussed above, the template processor 2204 receives an image from the personal mobile communication device 200a, extracts text from the image, and identifies relevant medical information from the image, as described above. For this purpose, the appropriate data template may be selected from database 2208.

In some embodiments, the template processor 2204 may receive a stream of messages from the personal mobile communication device 200a that includes the patient medical template 2100 or substantially all medical information for the patient's medical record. In these embodiments, the template processor 2204 provides indicator, metadata, and / or device data field information with the data to determine the data fields of the template 2100 to which data should be populated or written. To read. The template processor 2204 provides, for example, the metadata or information of the module (or the data field 2102-2120 itself) with medical information to determine the appropriate data field for the template 2100. Match device data field information.

After populating the patient medical template or otherwise completing it, the template processor 2204 of FIG. 22 is configured to store the completed template in the clinician database 1010. This may include using template 2100 to populate the patient's medical record, where the fields in the template correspond to, are linked to, or referenced to the fields in the patient's medical record. In another example, writing to a medical record may include storing the populated template in the patient's medical record, or storing the template 2100 as the medical record itself.

23 and 24 are diagrams using images (and / or text messages received from it) recorded by the personal mobile communication device 200a of FIGS. 10-12 and 22 according to certain exemplary embodiments of the present disclosure. 21 is a flow diagram of exemplary procedures 2300 and 2350 for populating the medical device template 2100. Procedures 2300 and 2350 are described with reference to the flow diagrams illustrated in FIGS. 23 and 24, but it is understood that many other methods of performing the steps associated with procedures 2300 and 2350 can also be used. I want to be done. For example, many orders of blocks can be changed, one block can be combined with another, and many of the described blocks can be arbitrary. In certain embodiments, the order of the blocks can be modified if there is no persistent connection between the clinician server 200b and the personal mobile communication device 200a. Instead, in embodiments, the personal mobile communication device 200a first has virtually all relevant medical information about the patient medical template until a connection with the clinician server 200b is available (or intentionally). Can be obtained and put in the queue. The actions described in procedures 2300 and 2350 may be performed across multiple devices, including, for example, the personal mobile communication device 200a and the clinician server 200b.

The exemplary procedure 2300 is initiated in FIG. 23 when the clinician server 200b of FIGS. 10-12 and 22 receives message 2301 from the personal mobile communication device 200a (block 2302). Message 2301 indicates the treatment to be performed on the patient or a request to initiate transmission of medical information. The clinician server 200b then determines a patient medical template (eg, patient medical template 2100 in FIG. 21) based on the treatment type specified in message 2301 or the prescribed treatment specified in the patient's medical record. (Block 2304). In the case where the clinician server 200b provides only the completion of one type of template (eg, a template for renal failure therapy), message 2301 may indicate a request to initiate the submission of a blank template. In response to message 2301, the clinician server 200b makes a copy of the patient medical template for data entry.

After providing the patient medical template for data entry, the clinician server 200b is at least one medical device that requires medical information (using the routine associated with the template or reading the template itself). And accordingly, the first camera message 2305 is transmitted to the personal mobile communication device 200a (block 2306). The first camera message 2305 contains, for example, an instruction indicating that an image of the medical device identifier 1012 should be recorded. After a while, the clinician server 200b receives message 2307 (eg, block 2308) containing medical information indicating the type of medical device (eg, medical information from identifier 1012a). The clinician server 200b then determines a device data template (eg, device data template 1700 in FIG. 17) based on the information contained within message 2307 or as defined in the patient's medical record (block 2310). ). For example, after message 2307 determines to identify the blood pressure monitor 104 (type and / or model), the clinician server 200b determines or finds a device data template for the blood pressure monitor. The clinician server 200b loads a device data template to identify the relevant medical device data from the received image on the screen of the blood pressure monitor 104 (block 2312).

The exemplary procedure 2300 continues in FIG. 24, where the clinician server 200b transmits a second camera message 2313 to the personal mobile communication device 200a (block 2314). The second camera message 2313 may be determined based on the type of medical device defined by message 2307. In addition, the second camera message 2313 may include information for displaying a window (or related medical information) on the medical device for recording an image. After a while, the clinician server 200b receives a message 2315 containing text or an image thereof from the window of the medical device (block 2316). The exemplary clinician server 200b uses the identified data template to extract relevant medical information from the image and determines or otherwise identifies the data fields of the patient medical template corresponding to the relevant medical information. (Block 2318). If message 2315 contains text, the clinician server 200b determines or otherwise identifies the data fields of the patient medical template corresponding to the relevant medical information. The clinician server 200b then populates the template determination and / or identified data fields with the relevant received medical information (block 2320).

After populating the relevant data field, the exemplary clinician server 200b determines if additional relevant medical information is required from the medical device associated with the received relevant medical information. (Decision block 2322). For example, the clinician server 200b may determine that the current medical device may include additional windows or motion displays for which relevant medical information is still needed. If additional medical information is needed, the exemplary clinician server 200b returns to block 2314 and transmits a camera message 2313 for another window where the relevant medical information is needed. However, if no additional medical information is needed for the current medical device, the clinician server 200b determines if the medical information is needed from another medical device (or consumable item 1006). (Decision block 2324). If additional medical information is needed, the clinician server 200b returns to block 2306 and transmits a camera message 2305 identifying another medical device for imaging or receiving related medical information. do. If no additional medical information is required for the completion of the patient medical template 2100, the exemplary clinician server 200b stores the completed patient medical template 2100 in the clinician database 1010 as a patient medical record. Procedure 2300 ends.

The exemplary procedure 2350 is initiated in FIG. 23 by the personal mobile communication device 200a transmitting a message 2301 indicating treatment to be performed to the patient or a request to begin inputting medical information (2352). .. The personal mobile communication device 200a then receives the camera message 2305 from the clinician server 200b. The information from message 2305 is used by the personal mobile communication device 200a to prompt the patient (block 2354). The prompt may specify, for example, that the medical device identifier 1012 should be imaged. The personal mobile communication device 200a then records an image of the medical device identifier 1012 based on input from the patient (block 2356). In some embodiments, the patient enters text defining the medical device type / model if the identifier is not available or if the patient does not want (or cannot) record an image. Or you can select from the drop-down menu.

After recording the image of the identifier 1012, the personal mobile communication device 200a extracts or otherwise determines the medical information encoded in the identifier (block 2358). The personal mobile communication device 200a transmits the extracted medical information to the clinician server 200b in message 2307. In some embodiments, the personal mobile communication device 200a instead transmits the recorded image in message 2307.

The personal mobile communication device 200a then receives a camera message 2313 from the server 200b with information to display to the patient a prompt to record an image of the screen (or other defined area) of the medical device (the personal mobile communication device 200a). Block 2360). The personal mobile communication device 200a accordingly displays to the patient a prompt with the information needed to image the medical device. In response to the prompt, the patient uses the personal mobile communication device 200a to record an image of the screen (or other defined area) of the medical device (block 2362).

In FIG. 24, the exemplary procedure 2350 is continued by the personal mobile communication device 200a creating a text message with a recorded image or text entered by the patient (block 2364). In some examples, the patient may modify or prescribe medical information. The personal mobile communication device 200a then transmits a message 2315 containing medical information or an image thereof (block 2366).

The exemplary personal mobile communication device 200a then determines whether additional relevant medical information is required from the medical device associated with the extracted relevant medical information (decision block 2368). The decision may include, for example, checking whether additional camera messages related to the current medical device are being received from the clinician server (block 2360). If additional medical information is needed, the exemplary personal mobile communication device 200a returns to block 2360 and another window (or part of the medical device / consumable item) where the relevant medical information is needed. Processes camera message 2313 with respect to. However, if no additional medical information is needed for the current medical device, the personal mobile communication device 200a determines if the medical information is needed from another medical device (or consumable item 1006). (Decision block 2370). If additional medical information is needed, the personal mobile communication device 200a returns to block 2354 and processes camera message 2305 identifying another medical device for imaging. If no additional medical information is required for the completion of the patient medical template, the exemplary personal mobile communication device 200a ends the session, thereby ending procedure 2350.

(6. Manual / wireless / image medical information input via web browser or file transfer)
In some embodiments, the data acquisition module 1104 of FIG. 11 allows a patient to use his or her personal mobile communication device 200a to enter medical information via a web browser or file transfer program, or to provide an image. It is configured to allow you to. A web browser or file transfer program allows the personal mobile communication device 200a to provide medical information and / or images without the use of application 1002. In this embodiment, the clinician server 200b hosts a website, API, and / or file transfer site to which an address or uniform resource locator (“URL”) is assigned. A web browser or file transfer program on the personal mobile communication device 200a is configured to access a hosted website, API, and / or file transfer site and transmit medical information.

In some embodiments, the data acquisition module 1104 is configured to prompt the patient to enter a username and password to access a website or file transfer site. In another embodiment, the data acquisition module 1104 determines that the personal mobile communication device 200a is previously registered and provides access. Still in other embodiments, the data acquisition module 1104 is a mailbox or other interface (eg, for example) for receiving medical information or images without providing access to a secure location by the personal mobile communication device 200a. API) is provided.

When the patient gains access via the personal mobile communication device 200a, the data acquisition module 1104 provides, in some embodiments, a graphical user interface that prompts the patient for medical information and / or images. The user interface may resemble the user interfaces 1400 and 1500 described in relation to FIGS. 14 and 15. Similar to the personal mobile communication device 200a including the application 1002, the clinician server 200b provides a user interface and data fields for receiving medical information. The data acquisition module 1104 may also allow the patient to select a data entry method such as text or image.

In some embodiments, the clinician server 200b may provide a menu to allow the patient to select the appropriate user interface. In another embodiment, the clinician server 200b may select a user interface in which medical information is required, based on the prescribed treatment or treatment information provided by the patient. Still in other embodiments, application 1020 of the clinician server 200b may run routine 2150, which provides a graphical prompt for medical information.

FIG. 25 shows a schematic representation of a clinician server 200b hosting a website or file transfer site for receiving medical information via images from a personal mobile communication device 200a, according to an exemplary embodiment of the present disclosure. In the illustrated example, the personal mobile communication device 200a is running a web browser application 2500 directed to a website 2502 hosted by a clinician server 200b. Website 2502 includes a graphical user interface for entering medical information. In this example, the personal mobile communication device 200a records an image 1800 of the screen of the blood pressure monitor 104 of FIG. The clinician server 200b applies the data template 1801 to the image and extracts a set of texts as shown in fields 1802, 804, 1806, 1808, and 1810. The patient selects fields 1802, 804, 1806, 1808, and 1810 at which the text should be populated in one or more selected data fields on website 2502. Thus, the clinician server 200b allows the patient to provide medical information via a website, file transfer program, or API.

(C. Data access module embodiment)
Looking back at FIG. 11, the exemplary data access module 1106 is configured to provide patients and clinicians with access to medical information stored in medical records in the clinician database 1010. As described above in connection with the data acquisition module 1104, there are different possible configurations of the personal mobile communication device 200a with or without application 1002 installed. The data access module 1106 is configured to provide access or otherwise display data based on the configuration. To determine the configuration used by a particular patient, the exemplary data access module 1106 accesses a registration table or patient medical record, and the registered personal mobile communication device 200a and / or application 1002 is installed. It is configured to identify whether or not it is.

In some embodiments, the data access module 1106 is configured to provide medical information differently based on the operating system of the personal mobile communication device 200a and / or the capabilities of the personal mobile communication device 200a. For example, a first subset of medical information may be defined for the feature-rich personal mobile communication device 200a, while a second subset of medical information is provided for the feature-less personal mobile communication device 200a. To. Based on the registration information, the data access module 1104 determines whether the application 1002 is running on a feature-rich device or a feature-less device, and the corresponding first or first of the medical information. Select the second subset.

An exemplary data access module 1106 may determine whether medical and / or treatment information in a patient's medical record should be converted to a different format prior to transmission. For example, medical information and / or treatment information may be stored in medical records in HL7 format. However, this format is not suitable for text messages and / or applications. The exemplary data access module 1106 determines the capabilities of the personal mobile communication device 200a through which data should be transmitted. The data access module 1106 determines the capability based on registration information indicating whether the application 1002 is installed and / or the personal mobile communication device 200a is a feature-rich device. To browse medical information on application 1002, the data access module 1106 uses one or more APIs to extract medical and / or treatment information from HL7 format, eg, a hypertext markup language (“HTML”). ) Format, Java® Script object notation (“JSON”) format, or XML format (eg, application format). If the data access module 1106 determines that the application 1002 is not installed, the data access module 1106 converts the information from the HL7 format to a text message or SMS message format, eg, via one or more APIs. do. The exemplary data access module 1106 therefore allows patient medical record information to be viewed by the patient regardless of the capabilities of his personal mobile communication device 200a.

(1. Information display embodiment via application)
In some embodiments, the data access module 1106 is configured to display medical and / or treatment information via application 1002 installed on the personal mobile communication device 200a. In these examples, the data access module 1106 provides medical information from one or more patient records for display in defined fields, graphs, etc. of one or more user interfaces provided by application 1002. .. In some cases, the fields from the medical record are referenced to the fields in the user interface of application 1002.

FIG. 26-29 shows a schematic representation of application 1002 on a personal mobile communication device 200a displaying medical information provided by access module 1006, according to an exemplary embodiment of the present disclosure. Application 1002 may be configured to display different user interfaces 2600, 2700, 2800, and 2900, depending on the patient's choice. In some cases, application 1002 provides a menu or other selectable graphical feature that lists the different user interfaces available. Application 1002 may be configured to receive medical information via one or more APIs linked to the data fields of the patient's medical record. In other words, medical information from patient records is plugged into a blank template that defines a graphical user interface for displaying medical information.

The user interface 2600 of FIG. 26 includes a first graph 2602 illustrating the total UFs removed per day and a second graph 2604 illustrating the average UFs removed per separate day / night exchange. I will provide a. It should be appreciated that the medical information displayed in graphs 2602 and 2604 may be derived from the home therapy machine 90 and / or one or more medical devices. The data access module 1106 of the clinician server 200b provides access to medical information from different sources as long as the information is already stored in the patient's medical records, thereby providing information transparency to the patient.

The user interface 2600 is configured to allow the patient to select data points on graphs 2602 and 2604 to provide additional treatment information. User interface 2600 allows the patient to select a time range for graphs 2602 and 2604. After receiving the selection, application 1002 transmits a message indicating the selection to the data access module 1106. In exchange, the data access module 1106 provides the requested medical information.

The exemplary user interface 2700 of FIG. 27 illustrates the average discharge time for each UF exchange. Discharge times are provided in Graph 2702. Between the user interfaces 2600 and 2700, the patient can measure how the treatment progresses over time. Any deviations in treatment should be readily apparent and help convince the patient to adhere to the prescribed therapy.

The exemplary user interface 2800 includes a calendar indicating the days on which the patient adhered to the treatment or therapy as compared to the days on which the patient did not comply with the therapy. The patient may choose one of those days to view additional medical information. For example, user interface 2900 presents treatment or medical information regarding April 26th. The information includes a breakdown of UFs removed during manual replacement compared to UFs removed via the home therapy machine 90, as well as the total amount of UFs removed during the day. In the illustrated embodiment, the mechanical treatment information includes the program name, the prescribed treatment time, the actual treatment time, and the amount of UF removed. The data access module 1106 may determine whether treatment has been adhered to based on the fact that the actual treatment time is within the prescribed treatment time threshold. In some embodiments, the data access module 1106 and / or the data acquisition module 1104 determines compliance upon receipt of medical or treatment information and sets the corresponding flag or other indication in the patient's medical record. , May reflect compliance or lack thereof.

In some examples, treatment information for manual replacement is input by the patient via application 1002 on the personal mobile communication device 200a, while machine treatment information is received separately from the home therapy machine 90. In another example, the user interface 2900 may display treatments performed at the patient's home and treatments performed in the clinic. The information may be organized based on the machine on which the information was received, the program name, treatment type, prescription, etc. The user interface 2900 in the illustrated example accordingly provides a single indication of the UF removed for different exchanges, thereby patient information regarding the effectiveness of the manual exchange compared to the mechanically operated exchange. I will provide a. The exemplary system 100 of FIG. 10 allows information from both exchanges to be stored together (based on the date of treatment) for subsequent display and / or analysis.

(2. Information display embodiment via a web browser)
In some embodiments, the personal mobile communication device 200a may not have application 1002 installed. Alternatively, the patient may use a web browsing application to access a website or interface hosted by the clinician server 200b. In these embodiments, the data access module 1006 is configured to display medical and / or treatment information on one or more web pages, similar to the user interface 2600-2900 of FIGS. 26-29. In this embodiment, the personal mobile communication device 200a accesses the data access module 1106 via a website. User interface or feature selection via the personal mobile communication device 200a causes the data access module 1106 to display medical information within a web page. The data access module 1106 may be configured to format or render medical and / or therapeutic information based on the web browser type and / or operating system of the personal mobile communication device 200a. In some cases, the data access module 1106 may request a username and password from the patient prior to providing access to the website.

(3. Information display embodiment via text)
In some embodiments, the data access module 1106 is configured to provide medical and / or therapeutic information to the personal mobile communication device 200a via text messages. In these examples, the data access module 1106 may provide information in response to text received from the personal mobile communication device 200a. In another example, the data access module 1106 may periodically (eg, daily, weekly, etc.) transmit medical and / or treatment information to the patient's personal mobile communication device 200a.

In one example, the data access module 1106 may receive a text message containing the text "Send 7 days of UF data". In response, the data access module 1106 identifies the patient record corresponding to the telephone number of the personal mobile communication device 200a for which the text message was received. The data access module 1106 then uses a look-up table or keyword search to open fields in the patient's medical record that contain a matching set of characters or texts associated with UF data (eg, "7-day UF"). Can be identified. The data access module 1106 copies the matching text and creates a reply message with a UF value for the previous 7 days, which is transmitted to the personal mobile communication device 200a. In addition, or as an alternative, the data access module 1106 creates and renders a 7-day graph, similar to graph 2602 in FIG. The data access module 1106 creates an image of the graph, which is transmitted to the personal mobile communication device 200a as an image in a text message. The image is. jpeg ,. gif ,. It can be stored as a file such as png. Patients with the personal mobile communication device 200a may view the graph via text message. Thus, the exemplary data access module 1106 is configured to provide patient access to medical and therapeutic information regardless of the capabilities and / or operating system of its personal mobile communication device 200a. In addition, the data access module 1106 is a method by which data should be transmitted based on instructions as to whether the registration information and / or application 1002 provided by the patient is installed on the patient's personal mobile communication device 200a. To determine.

(4. Alarm / alert embodiment)
In addition to providing display of medical and / or treatment information, the exemplary data access module 1106 of FIG. 11 is to determine alarms and / or alerts for patients and / or clinicians, and / or. It is configured to generate. The data access module 1106 may transmit alarms and / or alerts to the patient's personal mobile communication device 200a or clinician device 152. In some embodiments, the data access module 1106 may include a rule table that defines the device on which certain alarms / alerts should be transmitted. The clinician may use the clinician device 152 to subscribe to certain alarms / alerts and / or patients.

The data access module 1106 is configured to provide alarms / alerts based on how the personal mobile communication device 200a is configured to display medical and / or treatment information. For example, if application 1002 is installed, data access module 1106 provides alarms / alerts through the appropriate user interface of application 1002. In some cases, application 1002 is configured to display notifications indicating alarms / alerts. If application 1002 is not installed, the data access module 1106 determines that alarms and / or alerts should be transmitted to the personal mobile communication device 200a via SMS or other text messages.

In some embodiments, the data access module 1106 comprises or has access to a data structure or list that defines certain conditions under which an alarm or alert should be raised. In one example, the condition may compare a single data value or trend (eg, a 30-day moving average) to an acceptable range of values and / or thresholds (which may include hard and / or soft limits). In another example, an alarm or alert can be generated based on multiple conditions based on comparing different types of information with their respective limits. In some cases, the data access module 1106 determines derived information calculated from treatment and / or medical information, which is then compared to an acceptable range. The following provides examples of alarms / alerts that can be transmitted by data access module 1106 and / or displayed within application 1002 via text messages.

In one example, the data access module 1106 may raise an alarm or alert if it is detected that the patient is beginning to deviate from the prescribed treatment. For example, after detecting that two days have passed since the treatment information was received, the data access module 1106 (which operates according to the alert rule) transmits an alert message to the personal mobile communication device 200a. The alert message stipulates, for example, that the patient should perform treatment. The alert message may also include information (or a link to information) that explains why the treatment is important or explains to the patient what happens to the patient if the treatment is not given in a timely manner. .. If the data access module 1106 detects, for example, that no treatment information has been received for 4 days, the data access module 1106 promotes the alert to an alarm (which operates according to the alarm rule). The data access module 1106 transmits an alarm to the personal mobile communication device 200a and / or the clinician device 152 to provide an indication of the seriousness of non-compliance with treatment. As mentioned above, alarms and / or alerts may be transmitted by the data access module 1106 based on whether application 1002 is installed. The data access module 1106 is configured to transmit text messages to the personal mobile communication device 200a to draw the patient's attention even when the application 1002 is installed.

In some cases, the patient is prescribed a manual replacement. Therefore, the patient needs to provide treatment information indicating manual replacement. The data acquisition module 1106 is configured to transmit an alarm or alert if manual exchange information is not received within a predetermined time period (eg, within 2 days after scheduled treatment). In addition, if the manual replacement is not completed properly (eg, short filling or residence time), the data access module 1106 sends alerts and / or alarms for inadequate replacement. To determine inadequate replacement, the data access module 1106 may compare fill, retention, and / or discharge times to pre-established acceptable ranges and / or thresholds. In some cases, the data access module 1106 may require the patient to perform a complete replacement.

In certain examples, alarms and / or alerts can be generated to indicate that a patient should select a different treatment program from multiple prescribed treatment programs or make adjustments to the treatment program. .. In this example, an alarm or alert rule may specify that the data access module 1106 should calculate the accumulated fluid value and compare the patient's blood pressure or weight to their respective thresholds of change while comparing them to certain thresholds. .. The accumulated fluid value can be determined from the individual fluid filling and draining volumes, which indicates the fluid remaining in the patient's abdominal cavity. The data access module 1106 raises an alarm if blood pressure or body weight and accumulated fluid values (or trends) are out of acceptable range. The alarm is that the patient is accumulating fluid and a treatment program with a longer drainage duration (or shorter filling duration) should be selected (or the treatment program has a longer drainage duration or shorter drainage duration). It can be indicated that it should be adjusted to provide a filling duration). The data access module 1106 transmits an alarm for display on the personal mobile communication device 200a. The patient may respond via application 1002 or text message and have the clinician server 200b make appropriate changes to the patient's prescription or therapy program.

In some embodiments, alarms and / or alerts may specify conditions under which additional information should be prompted by the patient. In these embodiments, the data access module 1106 uses the treatment information from the home therapy machine 90 as a basis for determining whether the patient should provide medical information via the personal mobile communication device 200a. In one example, the data acquisition module 1106 may access alarms and / or alert rules that specify the conditions under which a prompt or text message prompting for additional weight or blood pressure measurements is sent to the patient's personal mobile communication device 200a. .. For example, an alarm or alert may specify that a new blood pressure measurement prompt is required if the blood pressure value (or tendency) exceeds a predetermined threshold. In another example, an alarm or alert may specify that a new blood pressure measurement prompt is required if the accumulated fluid value or the removed UF value (or trend) is out of acceptable range. In response, the data access module 1106 transmits a text message or notification for the patient to perform and record a blood pressure measurement via application 1002. In some cases, application 1002 may open a user interface (eg, user interface 3000 in FIG. 30) that prompts the patient to enter blood pressure information. If the additional data received from the personal mobile communication device 200a is not within acceptable limits, the data access module 1106 promotes the alert to an alarm transmitted to the clinician device 152 and / or the personal mobile communication device 200a. I can let you. Therefore, the data access module 1106 activates a rule that determines patient conditions on the borderline that seeks additional information from the patient before determining whether further attention or action is required by the clinician or patient. It is composed.

In a further embodiment, the rules of the data access module 1106 may instruct the patient to inspect and / or modify the home therapy machine 90. In one example, the rule stipulates that the data access module 1106 should transmit an alert to the patient if no treatment information has been received from the home therapy machine 90 within a defined time period (eg, 2 days). Can be. Under this circumstance, the patient may also provide medical information indicating that treatment has been performed and the data access module 1106 does not require an alert regarding adherence to treatment using it. Decide that. Instead, the data access module 1106 should transmit an alert to the patient to check the network connection of the home therapy machine 90 so that the treatment information stored on the machine 90 can be read out. To determine. The patient may respond to an alert using the personal mobile communication device 200a to indicate that the connection has been checked. After the response from the patient is received, the data acquisition module 1104 may send a pin message to the home therapy machine 90 regarding the missing treatment information. If the connection is still not possible, the data access module 1106 alerts with more specific instructions to activate the home therapy machine 90 and / or to overcome network connectivity issues. May be sent to the patient, clinician, and / or network administrator.

In another example, the data access module 1106 may include one or more rules that specify that an alert should be generated in response to the treatment information being out of range. For example, a large difference between the fluid filling volume and the draining volume may indicate a leak in the dialysis tube or connection to the patient. In response, the data access module 1106 sends an alert to the patient prompting the patient to verify the fluid connection. The patient may provide a response indicating whether a leak has been detected. In response, the data access module 1106 determines if the leak has been corrected in the subsequent treatment cycle (or primary sequence) or if the tubing should be replaced. The data access module 1106 may determine similar consumables issues with respect to cassettes, cartridges, etc., based on treatment and / or medical information. For example, a small volume of UF removed may prompt the data access module 1106 to transmit an alert for the patient to verify the concentration of dialysis fluid and / or concentrate connected to the home therapy machine 90. ..

(D. Treatment control module embodiment)
The exemplary treatment control module 1110 of FIG. 11 is configured to allow the patient and / or clinician to modify the prescription and / or program on the home therapy machine 90. To operate, the home therapy machine 90 is assigned one or more prescriptions for the patient. The prescription is the type of treatment (eg, automated peritoneal dialysis treatment, manual replacement treatment, hemodialysis treatment, etc.), the length of time the patient should be treated, the glucose or other concentrate level of the treatment fluid, the daily unit of UF to be removed. And / or the number of times per day or the duration range for each treatment may be specified. Each prescription may include one or more programs. The program may specify the duration of treatment, the total volume of fluid to be provided to the patient, the number of fillings, retentions, drainage cycles to be repeated, and / or instructions on whether the treatment includes tidal therapy. Differences in the program within the prescription allow the patient or clinician to change certain treatment parameters based on the patient's condition or activity.

Prescriptions and associated programs are stored in electronic prescriptions in the clinician database 1010. In some embodiments, the prescription may be stored in the patient's medical record. The home therapy machine 90 is programmed with one or more prescriptions. Programming may be performed locally via the clinician or patient or remotely from the clinician server 200b. For example, the clinician server 200b (eg, treatment control module 1110) may send a copy of the prescription from the clinician database 1010 to the home therapy machine 90 after registration.

In some embodiments, the exemplary treatment control module 1110 operates in connection with the application 1002 and / or the clinician device 152 on the personal mobile communication device 200a, with different patients and / or clinicians. It is configured to allow selection of prescription programs and / or prescriptions. FIG. 31 shows a schematic representation of the user interface 3100 of application 1002 that allows a patient to choose between three different programs: a short-term program, a long-term program, and a weekend program. Patients may choose a program based on their activities and / or circumstances. In some embodiments, application 1002 may display an alert from the data access module 1106 that provides recommendations for modifying the program based on the detected accumulation of fluid, weight gain, or higher blood pressure.

After the patient selects a different program via the user interface 3100, application 1002 sends a message indicating the selection to the treatment control module 1110. In response, the treatment control module 1110 updates the patient's medical record to reflect the modified program, including the time / date of modification. Further, the treatment control module 1110 transmits a message to the home therapy machine 90 providing an instruction to change to the selected program. In some cases, the message may include treatment parameters for the newly selected program. The home therapy machine 90 accordingly performs the next treatment based on the newly selected program. In some cases, the home therapy machine 90 may display a prompt for the patient to confirm the new program before operating according to the program.

In some embodiments, the treatment control module 1110 may perform a check to verify whether the patient is authorized to modify the program and / or whether the modification is permitted. For example, the treatment control module 1110 receives an instruction that the patient wants to change from a short-term program to a long-term program. The treatment control module 1110 compares the patient's medical information with one or more thresholds to ensure that the changes will not adversely affect the patient. For example, the treatment control module 1110 may not approve a change from a short-term program to a long-term program if the patient has already accumulated a relatively large volume of fluid. If the change cannot be made, the treatment control module 1110 sends a message to the personal mobile communication device 200a indicating why the change cannot be made.

In certain embodiments, the treatment control module 1110 may send a notification to the clinician device 152 indicating that the patient wants to change the program. The treatment control module 1110 may not communicate changes to the home therapy machine 90 until confirmation is received from the clinician device 152. In some embodiments, the clinician may use his clinician device 152 to modify the program and / or prescription via the treatment control module 1110. In these embodiments, the treatment control module 1110 may send a message for display in application 1002 of the personal mobile communication device 200a indicating that the changes have been made in the program and / or the clinician has made the changes.

In the case where the personal mobile communication device 200a does not include the application 1002, the treatment control module 1110 is configured to allow prescription changes. For example, the treatment control module 1110 may host a website accessible by a web browser on the personal mobile communication device 200a. The website may include features similar to the user interface 3100 of FIG. 31 to allow patients to remotely select different programs and / or prescriptions.

In addition, or as an alternative, the treatment control module 1110 is configured to allow treatment changes via text messages. In one example, the patient may send a message containing the text "change treatment" from the personal mobile communication device 200a. In response, the treatment control module 1110 is configured to send a reply message with different treatment program options and the corresponding code or indicator next to each option. The patient may enter an indicator or code in the response message to select the desired program. In another example, the patient may send a message with a text consisting of, for example, a "long-term program" to cause the treatment control module 1110 to change the program to a long-term program.

(E. Education module embodiment)
The exemplary education module 1108 of FIG. 11 is configured to provide educational materials and / or incentives to the patient via the personal mobile communication device 200a. Like the other modules 1102-1106 and 1110 in FIG. 11, the education module 1108 is configured to provide content / information based on the configuration of the personal mobile communication device 200a. For example, if application 1002 is installed, education module 1108 is configured to select and provide educational material through application 1002. If the application is not installed, Education Module 1108 is configured to provide educational materials via websites and / or text messages. In the case of text messages, the education module 1108 either structures the educational material to fit within the text message, or links to the educational material in the clinician database 1010, or to the educational material hosted by a third party server. Can be configured to provide.

As described herein, educational material may include text-based articles, audio, video, multimedia presentations, and the like. Educational material may provide general information about the patient's condition, information about application 1002, and / or information about the home therapy machine 90. Educational material may also be targeted based on detected patient conditions (determined from their own medical records) and / or feedback on the patient's use of applications 1002 and / or home therapy machine 90.

As also described herein, encouragement includes text, audio, video, or multimedia presentations designed to improve the patient's mood or help the patient adhere to the program. Encouragements can also include rewards or badges. In some embodiments, the education module 1108 may be configured to provide incentives based on the detected conditions. In some cases, incentives may be provided in combination with alerts generated by data access module 1106. In some examples of encouragement, different status levels may be provided to the patient based on the rate of compliance (eg, "dialysis SupaStar" for near complete compliance).

Educational material and / or incentives may be stored in the clinician database 1010. In addition, Education Module 1108 may have access to third party materials such as from the National Institutes of Health or Cleveland Clinic®. Education module 1108 may include a rule data structure that defines the conditions under which certain educational material and / or incentives should be provided to the personal mobile communication device 200a.

In one example, the data access module 1106 determines that the patient is not in compliance with treatment. In addition to the data access module 1106 sending alerts, the education module 1108 may recommend or provide links to videos on the importance of compliance. FIG. 32 shows an exemplary user interface 3200 of application 1002 displaying educational videos related to compliance provided by Education Module 1108. The exemplary user interface 3200 also provides a list of recommended educational materials based on the patient's detected conditions. For example, after a patient has been detected from medical records to have hypertension or received as medical information, the Education Module 1108 is configured to recommend educational content about lowering blood pressure. Further, after detecting that the patient has not changed the prescription program, the education module 1108 determines that educational content explaining the program options should be recommended.

An exemplary education module 1108 may detect how a patient interacts with application 1002 and recommend educational content. For example, Education Module 1108 indicates that the patient has made multiple attempts in populating a data field in a user interface (eg, user interface 14 in FIG. 14) using recorded images. Is received from the application 1002. In response, Education Module 1108 may provide notifications via application 1002 that encourage patients to view tutorials on information input using recorded images.

The exemplary education module 1108 may store any educational content or incentive instructions displayed by the personal mobile communication device 200a in the patient's medical record. Such information may be useful to the clinician to determine how the patient is involved in the treatment. The stored information may also provide an indication of the patient's awareness of the treatment.

(F. Auxiliary module embodiment)
The exemplary auxiliary module 1112 of FIG. 12 is configured to create a communication session with the patient's clinician. Specifically, the auxiliary module 1112 is configured to create a communication session between the clinician device 152 and the personal mobile communication device 200a. Auxiliary module 1112 may use the capabilities of the personal mobile communication device 200a to determine the appropriate communication session.

The communication session may include a video session, an audio call, a conference call, an SMS session, or a web messaging session. If application 1002 is installed, auxiliary module 1112 may have access to options for selecting a video session, conference session, or web messaging session to connect the patient to the clinician through application 1002. If application 1002 is not installed, auxiliary module 1112 may be limited to options related to the unique communication capabilities of the personal mobile communication device 200a such as text messaging and audio calling.

In some embodiments, the patient may initiate a session. Application 1002 is configured to allow a patient to request contact with a clinician, including defining preferred communication methods. Using the text features of application 1002, the patient may send a text message containing the text of "help" to auxiliary module 1112 to initiate a session. After the patient requests to start a session, auxiliary module 1112 is configured to identify available clinicians. In some embodiments, the auxiliary module 1112 may find the clinician's record associated with the patient and send a pin / request message to the device. The response received from one of the devices 152 provides an indication that the clinician is available and willing to communicate with the patient. In some cases, the response may indicate a clinician's method of communication. In response to the received message, auxiliary module 1112 initiates a communication session. This may include establishing a web call, messaging session, or audio call between the personal mobile communication device 200a and the clinician device 152. In some embodiments, instead of broadcasting a pin message to a group of clinicians, the auxiliary module 1112 is placed in a predetermined order (eg, first, most important clinician, second, waiting in the same office. Clinicians, third, waiting clinicians in different offices, etc.) may sequentially send pin / request messages to clinicians. FIG. 33 shows a schematic of the user interface 3300 of application 1002 that provides a video session with a clinician. Video sessions allow patients to address their concerns about their treatment. Video sessions also allow clinicians to view real-time settings for treatment or assist patients in setting treatment.

In some embodiments, the auxiliary module 1112 may determine that a communication session should be opened or recommend opening a communication session. Auxiliary module 1112 may provide recommendations in conjunction with the data access module 1106 raising alarms and / or alerts. The auxiliary module identifies the clinician device 152 that is available to participate in the session after detecting conditions for alerts and / or alarms, and then personal mobile communication to address alerts and / or alarms. A call to the device 200a may be initiated. In one example, the auxiliary module 1112 may create a communication session after detecting that a patient's blood pressure, body weight, accumulated fluid, etc. exceed a predetermined threshold or change significantly within a predetermined period of time. Can try.

An exemplary auxiliary module 1112 may determine the type of auxiliary sought to identify the correct individual with respect to the connection. In addition to the clinician, the auxiliary module 1112 may be able to connect to information technology specialists and home therapy machine specialists. Prior to initiating a session, application 1002 may prompt the patient to identify an auxiliary type (eg, application help, machine help, clinical help, etc.). In other cases, auxiliary module 1112 may determine the auxiliary type based on the context in which the requirements for the session are received. For example, after scrutinizing the education and training program for the home therapy machine 90, the auxiliary module 1112 determines that subsequent requests for assistance relate to operating the home therapy machine 90. In another example, while application 1002 is displaying a user interface for UF trends, auxiliary module 1112 determines that subsequent requests for assistance relate to clinical problems.

The exemplary auxiliary module 1112 may be configured to log communication sessions in the patient's medical record. Auxiliary module 1112 may record the date / time of the communication session and instructions on how the session started. The record may also include the participants of the communication session and the minutes of the communication. For text messages, this may include a copy of the message. With respect to audio or video, this may include recording a call or posting a call.

(III. Conclusion)
It should be appreciated that the various changes and modifications of this preferred embodiment described herein will be apparent to those of skill in the art. Such changes and modifications can be made without departing from the spirit and scope of the subject and without diminishing its intended benefits. Therefore, such changes and amendments are intended to be covered by the accompanying claims.

The advantages discussed herein can be found in one or several of the embodiments disclosed herein, and perhaps not all of them. Additional features and advantages will be described herein and will become apparent from the embodiments and figures for carrying out the invention below.
The invention further provides, for example,:
(Item 1)
A machine-accessible device that stores instructions, the instructions being configured to cause the machine to populate the patient medical record of the clinical system when executed. Inputting data is
To operate the camera and record the image,
To operate the display interface and
By operating a connection interface configured to connect to a clinician database, said clinician database is configured to store patient medical records.
To operate the processor and obtain medical information
By
Acquiring the medical information is
To display a user interface with a field to which medical information should be input via the display interface.
After selecting a data field in the user interface, graphically provide a first option for entering medical information from an image via the display interface and a second option for entering medical information via text input. To provide and
If the first option is selected,
Receiving a recorded image from the camera, wherein the recorded image includes a medical device or a screen of the medical device.
Extracting text from the image and
To enable selection of at least a portion of the text from the image via the display interface.
Writing the selected text from the image as the medical information into the data field of the user interface.
To do and
When the second option is selected, the text input of the data field as the medical information is enabled via the display interface.
After receiving the transmission command, the medical information written in the data field is transmitted to the patient medical record stored in the clinician database.
By machine accessible device.
(Item 2)
Further comprising instructions stored in the machine accessible device, the instructions are configured to cause the machine to operate the processor when executed, the processor.
Determining a data template for the extracted text on the image,
Using the data template to process the extracted text and classify the extracted text into fields.
Allowing the selection of at least one of the fields and writing the selected text from the image into the data field of the user interface.
The machine accessible device according to item 1.
(Item 3)
The machine-accessible device of item 2, wherein the data template is configured to define a context for the extracted text in relation to a text position in the image.
(Item 4)
Further comprising instructions stored in the machine accessible device, the instructions are configured to cause the machine to operate the processor when executed, the processor being (i) medical via the user interface. Device type selection, (ii) information scanned from an identifier located on the medical device, and (iii) at least one of the markers in the extracted text, or (iv) said. The machine-accessible device of item 2, wherein the data template is determined based on the relative arrangement of the extracted text.
(Item 5)
The identifier located on the medical device is a quick response (“QR”) code, barcode, serial number, or hardware located on the housing of the medical device or on the screen of the medical device. The machine accessible device of item 4, comprising at least one of the numbers.
(Item 6)
The machine accessible device according to item 1, wherein the medical device includes at least a renal failure therapy machine, an infusion pump, an oxygen sensor, a breathing monitor, a glucose meter, a blood pressure monitor, an ECG monitor, a weight scale, and a heart rate monitor.
(Item 7)
The data field of the user interface may contain at least one of blood pressure measurement data, pulse data, weight data, glucose data, temperature data, renal failure manual replacement data, subjective data, or consumable data for a consumable item. The machine-accessible device of item 1, which is configured to receive.
(Item 8)
Item 7, wherein the consumable item includes at least one of a filter, a blood line set, a dialysate concentrate container, a blood anticoagulant container, a drug container, a disposable cassette, an adsorbent cartridge, and a water purification container. Described machine accessible device.
(Item 9)
The machine accessible device according to item 1, wherein the machine is a personal mobile communication device.
(Item 10)
A method of inputting data into a patient medical record in a clinical database using recorded images.
The first message is to transmit the first message to the personal device, which prompts the patient to use the camera of the personal device and record the first image of the medical device. ,
Receiving the first image from the personal device and
Determining first medical information indicating the type or model of the medical device from the first image via a processor.
Determining a data template and a second message associated with the determined type or model of the medical device via the processor.
The second message is to be transmitted to the personal device via the processor, such that the second message uses the camera to record a second image of the screen of the medical device. Prompt the patient to
Receiving the second image from the personal device via the processor and
Extracting text from the second image via the processor,
Through the processor, the data template is used to process the extracted text and classify the extracted text into fields.
Writing at least a portion of the text from at least one of the fields into the patient medical record via the processor.
Including, how.
(Item 11)
Determining the correspondence between one of the fields and the recording field in the patient medical record via the processor.
Writing at least a portion of the text from the field into the recording field in the patient medical record via the processor.
10. The method of item 10.
(Item 12)
Determining treatment time from the patient medical record via the processor,
To transmit the first message via the processor before the treatment time.
10. The method of item 10.
(Item 13)
Receiving a treatment message from the personal device on the processor indicating that the patient should start treatment.
To transmit the first message via the processor before the treatment is started.
10. The method of item 10.
(Item 14)
The first image is received by the processor via a first text message or a first short messaging service (“SMS”) message, and the second image is a second text message or a second. 10. The method of item 10, which is received by the processor via an SMS message.
(Item 15)
Further comprising converting said at least a portion of the text from at least one of the fields into a health level 7 (“HL7”) format prior to writing to the patient medical record via the processor. , Item 10.
(Item 16)
To compare said at least a portion of the text from at least one of the fields with a predetermined range via the processor.
Of the text from at least one of the fields, if at least a portion of the text from at least one of the fields is within the predetermined range via the processor. To write at least part of the above
10. The method of item 10.
(Item 17)
A system for transmitting information to a patient, said system.
The patient's home therapy machine, configured to transmit treatment information,
A clinician database configured to store the medical record and the registration file, the registration file identifying the home therapy machine and the patient's personal device as registered devices, the personal device. A clinician database that identifies whether you have installed the treatment information and the application for viewing the medical information.
With the clinician database, the home therapy machine, and the clinician server communicably coupled to the personal device.
Equipped with
The clinician server
To store the treatment information and the medical information in the medical record,
Receiving instructions that at least a portion of the treatment information and the medical information should be displayed on the personal device.
From the registration file, determining whether the application is installed on the personal device, and
If the application is installed
Converting at least a portion of the treatment information and the medical information into an application format for display within the application.
To transmit at least a part of the medical information and the converted medical information to the personal device.
To do and
If the application is not installed
Converting the treatment information and at least a portion of the medical information into a text message or short messaging service (“SMS”) format and
To transmit at least a portion of the treatment information and the medical information to the personal device via one or more text messages or SMS messages.
To do
A system that is configured to do.
(Item 18)
17. The system of item 17, wherein the application format comprises at least one of an extended markup language ("XML") format or a hypertext markup language ("HTML") format.
(Item 19)
The instruction that at least a portion of the treatment information and the medical information should be displayed on the personal device is at least one of a message from the application or a text / SMS message from the personal device. 17. The system according to item 17.
(Item 20)
The system according to item 17, wherein the registration file is included in the medical record.
(Item 21)
The home therapy machine is configured to store a prescription using two programs, each of which provides parameters for operating the home therapy machine to perform treatment and the clinician. The server is
Receiving a program message from the personal device indicating the change from the first program to the second program, and
To transmit a program instruction for changing from the first program to the second program to the home therapy machine.
Item 17. The system according to item 17, which is configured to perform the above.

Claims (21)

A machine-accessible device that stores instructions, the instructions being configured to cause the machine to populate the patient medical record of the clinical system when executed. Inputting data is
To operate the camera and record the image,
To operate the display interface and
By operating a connection interface configured to connect to a clinician database, said clinician database is configured to store patient medical records.
By operating the processor and acquiring medical information,
Acquiring the medical information is
To display a user interface with a field to which medical information should be input via the display interface.
After selecting a data field in the user interface, graphically provide a first option for entering medical information from an image via the display interface and a second option for entering medical information via text input. To provide and
If the first option is selected,
Receiving a recorded image from the camera, wherein the recorded image includes a medical device or a screen of the medical device.
Extracting text from the image and
To enable selection of at least a portion of the text from the image via the display interface.
Writing the selected text from the image as the medical information in the data field of the user interface.
When the second option is selected, the text input of the data field as the medical information is enabled via the display interface.
A machine-accessible device by transmitting the medical information written in the data field to a patient medical record stored in the clinician database after the transmission command is received. Further comprising instructions stored in the machine accessible device, the instructions are configured to cause the machine to operate the processor when executed, the processor.
Determining a data template for the extracted text on the image,
Using the data template to process the extracted text and classify the extracted text into fields.
The machine-accessible device of claim 1, wherein the selected text from the image is written into the data field of the user interface, allowing selection of at least one of the fields. The machine-accessible device of claim 2, wherein the data template is configured to define a context for the extracted text in relation to a text position in the image. Further comprising instructions stored in the machine accessible device, the instructions are configured to cause the machine to operate the processor when executed, the processor being (i) medical via the user interface. Device type selection, (ii) information scanned from an identifier located on the medical device, and (iii) at least one of the markers in the extracted text, or (iv) said. The machine-accessible device of claim 2, wherein the data template is determined based on the relative arrangement of the extracted text. The identifier located on the medical device is a quick response (“QR”) code, barcode, serial number, or hardware located on the housing of the medical device or on the screen of the medical device. The machine-accessible device of claim 4, comprising at least one of the numbers. The machine-accessible device of claim 1, wherein the medical device comprises at least a renal failure therapy machine, an infusion pump, an oxygen sensor, a breathing monitor, a glucose meter, a blood pressure monitor, an ECG monitor, a weigh scale, and a heart rate monitor. The data field of the user interface may contain at least one of blood pressure measurement data, pulse data, weight data, glucose data, temperature data, renal failure manual replacement data, subjective data, or consumable data for a consumable item. The machine-accessible device according to claim 1, which is configured to receive. 7. The consumable item comprises at least one of a filter, a blood line set, a dialysate concentrate container, a blood anticoagulant container, a drug container, a disposable cassette, an adsorbent cartridge, and a water purification container. Machine-accessible devices described in. The machine-accessible device according to claim 1, wherein the machine is a personal mobile communication device. A method of inputting data into a patient medical record in a clinical database using recorded images.
The first message is to transmit the first message to the personal device, which prompts the patient to use the camera of the personal device and record the first image of the medical device. ,
Receiving the first image from the personal device and
Determining first medical information indicating the type or model of the medical device from the first image via a processor.
Determining a data template and a second message associated with the determined type or model of the medical device via the processor.
The second message is to be transmitted to the personal device via the processor, such that the second message uses the camera to record a second image of the screen of the medical device. Prompt the patient to
Receiving the second image from the personal device via the processor and
Extracting text from the second image via the processor,
Through the processor, the data template is used to process the extracted text and classify the extracted text into fields.
A method comprising writing at least a portion of the text from at least one of the fields into the patient medical record via the processor. Determining the correspondence between one of the fields and the recording field in the patient medical record via the processor.
10. The method of claim 10, further comprising writing at least a portion of the text from the field to the recording field in the patient medical record via the processor. Determining treatment time from the patient medical record via the processor,
10. The method of claim 10, further comprising transmitting the first message via the processor before the treatment time. Receiving a treatment message from the personal device on the processor indicating that the patient should start treatment.
10. The method of claim 10, further comprising transmitting the first message via the processor before the treatment is initiated. The first image is received by the processor via a first text message or a first short messaging service (“SMS”) message, and the second image is a second text message or a second. 10. The method of claim 10, which is received by the processor via an SMS message. Further comprising converting said at least a portion of the text from at least one of the fields into a health level 7 (“HL7”) format prior to writing to the patient medical record via the processor. , The method according to claim 10. To compare said at least a portion of the text from at least one of the fields with a predetermined range via the processor.
Of the text from at least one of the fields, if at least a portion of the text from at least one of the fields is within the predetermined range via the processor. 10. The method of claim 10, further comprising writing at least a portion of the above. A system for transmitting information to a patient, said system.
The patient's home therapy machine, configured to transmit treatment information,
A clinician database configured to store the medical record and the registration file, the registration file identifying the home therapy machine and the patient's personal device as registered devices, the personal device. A clinician database that identifies whether you have installed the treatment information and the application for viewing the medical information.
It comprises a clinician database, a home therapy machine, and a clinician server communicatively coupled to the personal device.
The clinician server
To store the treatment information and the medical information in the medical record,
Receiving instructions that at least a portion of the treatment information and the medical information should be displayed on the personal device.
From the registration file, determining whether the application is installed on the personal device, and
If the application is installed
Converting at least a portion of the treatment information and the medical information into an application format for display within the application.
To transmit at least a part of the medical information and the converted medical information to the personal device, and to perform the transmission.
If the application is not installed
Converting the treatment information and at least a portion of the medical information into a text message or short messaging service (“SMS”) format and
It is configured to transmit and perform transmission of at least a portion of the treatment information and the medical information to the personal device via one or more text messages or SMS messages. There is a system. 17. The system of claim 17, wherein the application format comprises at least one of an extended markup language ("XML") format or a hypertext markup language ("HTML") format. The instruction that at least a portion of the treatment information and the medical information should be displayed on the personal device is at least one of a message from the application or a text / SMS message from the personal device. 17. The system of claim 17. The system according to claim 17, wherein the registration file is included in the medical record. The home therapy machine is configured to store a prescription using two programs, each of which provides parameters for operating the home therapy machine to perform treatment and the clinician. The server is
Receiving a program message from the personal device indicating the change from the first program to the second program, and
The system according to claim 17, wherein a program instruction for changing from the first program to the second program is transmitted to the home therapy machine.

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