AU2014200633A1 - Data communication system for peritoneal dialysis machine - Google Patents

Abstract

Abstract: A portable peritoneal dialysis apparatus (10) having a USB interface for uploading and downloading patient files and records using a USB flash drive, and for playing a training video for the PD machine on the machine's own display, transferred via a USB flash drive.

Description

WO 2008/027967 PCT/US2007/077113 DATA COMMUNICATION SYSTEM FOR PERITONEAL DIALYSIS MACHINE 5 BACKGROUND OF THE INVENTION [00011 The present invention relates generally to apparatus for the treatment of end stage renal disease. More specifically, the present invention relates to portable apparatus for the performance of peritoneal dialysis. 10 100021 Dialysis to support a patient whose renal function has decreased to the point where the kidneys no longer sufficiently function is well known. Two principal dialysis methods are utilized: hemodialysis; and peritoneal dialysis. 100031 In hemodialysis, the patient's blood is passed through an artificial kidney 15 dialysis machine. A membrane in the machine acts as an artificial kidney for cleansing the blood. Because the treatment is extracorporeal, it requires special machinery and a visit to a center, such as in a hospital, that performs the treatment. 100041 To overcome this disadvantage associated with hemodialysis, peritoneal 20 dialysis (hereafter "PD") was developed. PD utilizes the patient's own peritoneum (a membranous lining of the abdominal body cavity) as a semi-permeable membrane. With its good perfusion, the peritoneum is capable of acting as a natural semi-permeable membrane. 25 100051 PD periodically infuses sterile aqueous solution into the peritoneal cavity. This aqueous solution is called PD, solution, or dialysate for short. Diffusion and osmosis exchanges take place between the solution and the blood stream across the peritoneum. These exchanges remove the waste. products that the kidneys normally excrete. The waste products typically consist of solutes like urea and creatinine. The kidneys also 30 function to maintain the proper levels of other substances, such as sodium and water, WO 2008/027967 PCT/US2007/077113 which also need to be regulated by dialysis. The diffusion of water and solutes across the peritoncal membrane during dialysis is called ultrafiltration. 100061 In continuous ambulatory PD, a dialysis solution is introduced into the 5 peritoneal cavity utilizing a catheter, normally placed into position by a visit to a doctor. An exchange of salutes between the dialysate and the blood is achieved by diffusion. 100071 In many prior art PD machines, removal of fluids is achieved by providing a suitable osmotic gradient from the blood to the dialysate to permit water outflow from the 10 blood. This allows a proper acid-base, electrolyte and fluid balance to be achieved in the body. The dialysis solution is simply drained from the body cavity through the catheter. The rate of fluid removal is dictated by height differential between patient and machine. 100081 A preferred PD machine is one that is automated. These machines are called 15 cyclers, designed to automatically infuse, dwell, and drain PD solution to and from the patient's peritoneal cavity. A cycler is particularly attractive to a PD patient because it can be used at night while the patient is asleep. This frees the patient from the day-to-day demands of continuous ambulatory PD during his/her waking and working hours. 20 100091 The treatment typically lasts for several hours. It often begins with an initial drain cycle to empty the peritoneal cavity of spent dialysate. The sequence then proceeds through a succession of fill, dwell, and drain phases that follow one after the other. Each phase is called a cycle. 25 100101 The intent of this invention is to provide improved data communications for a PD cycler. SUMMARY OF THE INVENTION [00111 In one aspect the peritoneal dialysis machine, according to the invention, 30 comprises a controller for directing the sequence of operations on PD cycler to carry out 2 WO 2008/027967 PCT/US2007/077113 peritoneal dialysis on the patient, together with a USB data communications interface including a USB port on the machine that accepts a USB flash drive, and a USB interface control system for managing the uploading and downloading of peritoneal dialysis related data, such as a digital record of therapy data following a treatment, a patient profile and 5 prescription, and a training video for the same machine playable on the machine's display using a built in media player. 100121 In another aspect the invention comprises a method of communicating with a PD machine by providing a USB interface including a USB port on the machine, 10 and using a USB flash drive inserted in the port either uploading patient data to the machine by transferring patient data to a USB flash drive and inserting the user's USB flash drive in the port or downloading treatment data to the user by transferring treatment data to a USB controller and inserting the user's USB flash drive in the port and then transferring the data onto the user's USB flash drive for transfer to a PC. 15 100131 In a further aspect the invention comprises playing a training video on the PD machine provided via the user's USB flash drive using the USB interface to transfer the file and a built in media player to play the training video on the PD machine's own display screen. 20 100141 The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. 3 WO 2008/027967 PCT/US2007/077113 DESCRIPTION OF DRAWINGS 100151 Fig. 1 is a perspective view of a PD cycler on a special cart with a heater bag 5 on the heater tray and additional PD solution bags for more exchanges hanging off the cart. 100161 Fig. 2 is a block diagram of the USB interface system within the PD cycler. 10 [0017] Numbers referring to the same items in several drawings will bear the same reference numbers. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 100181 The USB interface described below is specifically designed for PD cyclers of 15 the type disclosed in U.S. Patent Application Serial No. 11/069,195, filed February 28, 2005, entitled "Portable Apparatus for Peritoneal Dialysis Therapy," which is incorporated by reference herein in its entirety. In addition, this application hereby incorporates by reference the disclosure in a companion application filed by Kuilwinder Plahey the same day as this one, entitled "Improved Cassette System For Peritoneal 20 Dialysis Machine," application serial number _(attorney's docket No. 18196 061001). The foregoing applications are assigned to the same assignee and describe certain details of embodiments of the PD cycler shown in Fig. 1 of the present application. The Cycler 25 100191 In Fig. 1, a portable PD cycler 10 is shown seated on top of a cart 12 designed to accommodate the PD solution bags and associated tubing. The front of the cycler 10 includes a control panel 12 that furnishes a user interface designed to be operated by the patient along with a pressurized cassette compartment behind a hinged door 14. The 4 WO 2008/027967 PCT/US2007/077113 cassette (not shown) includes channels, flexible valve domes and diaphragm covered pumping chambers that are actuated by mating pneumatic valves and pistons interfacing with the cassette compartment to route the flow of PD solution from the bags through the cycler and to the patient and from the patient to a drain. The cassette and cassette 5 compartment are disclosed in more detail in the above-referenced application Serial No. 11/069,195. The cassette itself has tubing connectors 16 arrayed along its bottom edge. The connectors extend beneath the door 14 and are connected to tubing as shown in Fig. 1. 10 10020] PD solution bags 18 are suspended from fingers on the sides of the cart 12 as shown. A heater bag 20 is shown lying in a shallow concave depression forming the heater tray 22, which is sized and shaped to accommodate a typical 5 L bag of PD solution. The heater tray 22 has a plurality of heating coils (not shown) embedded below the surface. The surface of the tray 22 is slightly inclined downward to the right to assist 15 in emptying the heater bag which is arranged so that the outlet of the heater bag is also at the right side, adjacent to a temperature sensor 24 positioned in the surface of the heater tray 22 to track the temperature of the solution in the heater bag for a thermostatic control circuit that turns the heating coils on and off as needed to maintain the PD solution at the desired temperature. The heater tray 22 is also mounted internally on a support equipped 20 with a load cell (not shown) to provide an electrical signal indicating the weight of the contents of the PD solution bag to tell the cycler control system how full the heater bag is with PD solution. 100211 The PD cycler has a central programmed microprocessor-based controller for 25 directing the dialysis treatment according to the patient's prescription. This parameter entries, such as number and volume of fills, can be made on the control panel of the PD cycler for a given therapy and the machine will then step through the procedure according to the data entered by the user, in many cases the patient. During the procedure, information concerning cycle times and volumes actually encountered are recorded by 30 the machine and any anomalies or error conditions or alarms generated during the 5 WO 2008/027967 PCT/US2007/077113 procedure are noted in the record. The system is designed to record the date and time and create a record of the patient's treatment. 10022] There are several instances where the communication of data to and from the 5 PD cycler's control system would be desirable. First, data about the patient can be uploaded. This would include for example the patient's name, ID, age, weight before the procedure and other data about the patient's personal profile, as well as the prescribed treatment. Thus uploading of patient data could simplify the programming of a given treatment and provide a convenient way of monitoring data about the patient. 10 100231 Second following a treatment,-downloading a stored patient record could be beneficial in a number of ways. [0024] What is proposed to accomplish this is a Universal Serial Bus or USB 15 interface that will permit the patient or physician to insert a so-called flash drive memory device with a USB interface into a USB port on the PD cycler in order to upload and download data to and from the PD cycler's control system. This can permit the user to in effect download a "data sheet" following each treatment containing the number of cycles, fill and drain alarms, flow rates, etc., that occurred during the treatment. 20 100251 On the upload side, the patient would be able to use a simple USB flash drive to enter data into the PD cycler. This data could be stored on any PC. As all PC's have USB ports nowadays, the case and universality of use is drastically enhanced. Thus the patient might maintain a file on his or her PC with all pertinent patient profile data along 25 with the treatment parameters prescribed by the physician. This file could be maintained current by the patient and could include modifications in prescription made by the physician. In one scenario the physician using a file with a standardized format and adequate security to insure integrity could e-mail the patient a prescription which the patient could then store and transfer to the USB flash drive and then use the USB flash 30 drive to upload the data into the PD cycler. Similarly, the patient could download a data sheet about the treatment from the PD cycler onto his flash drive and then transfer the 6 WO 2008/027967 PCT/US2007/077113 data sheet to a PC and forward it as an attachment to an e-mail to his physician for inspection and logging as a permanent record. [0026] The hardware for accomplishing this USB interface is shown in Fig. 2. The 5 USB connector 30 can be implemented by a standard USB 2.0 port located on the back of the PD cycler housing 10 shown in Fig. 1 or any other convenient and safe location on the cycler. The USB connector 30 is connected to a USB 5 volt power monitor 32 and to a USB 2.0 controller 34 via a serial 2-line 12 Mbs data bus. The USB controller 34 detects and establishes communication via a standard protocol with the flash drive or 10 other USB device inserted into the port 30. The controller 34 manages the communication sequence and buffers the data onto or off of the 32 bit address and data lines as shown. The data and addressing lines are connected to a flash memory 36 and the host microcontroller 38 which is preferably a Power PC microprocessor system MPC 823 which is also available to run the other functions of the PD cycler. A complex 15 programmable logic device (CPLD) 40 is connected between the microcontrollcr 38 and the USB controller to assist in processing data according to the type of data being transmitted. 100271 One of the features of the USB interface for a PD cycler is its potential for 20 uploading playable media files that can be used for training and educational purposes by the user. This can be accomplished by storing a training video on a USB flash drive as an MPEG file, for example. The PD cycler would be equipped with a built in media player. Thus merely by inserting the flash drive into the USB port, the USB controller under the guidance of the CPLD 40 and the microcontroller 38 would automatically unpack and 25 play the training video using the available media player and video drivers for the display 12 on the front of the cycler (Fig. 1). The audio would be played as a wav file on speakers embedded in the cycler. This is a particularly valuable use of the USB interface as it permits the training to take place at home on the users own machine and allows the physician or clinician to prescribe the correct current training video for the patient to use 30 for the particular model of PD cycler that the patient has. 7 WO 2008/027967 PCT/US2007/077113 [00281 The invention has been described in terms of particular embodiments. Other embodiments are within the scope of the following claims. For example, steps of the invention can be performed in a different order and still achieve desirable results. 8

Claims (15)

1. A peritoneal dialysis (PD) machine, comprising: a source of PD solution; a PD cycler for routing and delivering the PD solution to a patient in need of peritoneal dialysis; a controller for directing a sequence of operations on the PD cycler to perform peritoneal dialysis on the patient; and a USB data communications interface including a USB port on the machine that accepts a USB memory device; and a USB interface control system for managing a retrieval of peritoneal dialysis related data from a USB memory device removably disposed in the USB port, the data including one or more patient-specific prescription records that, when used by the controller, direct the sequence of operations on the PD cycler.

2. The peritoneal dialysis machine of claim 1, further including a display screen; and a media player for playing an audio visual media file stored on the USB memory device, wherein the media player plays a training video on the display screen.

3. The peritoneal dialysis machine of claim 1, wherein the USB interface control system is configured to write, following a treatment, a digital record of therapy data onto a USB memory device for transfer to a personal computer.

4. The peritoneal dialysis machine of claim 1, wherein the data includes a patient profile and prescription record provided by a user, the record being stored on a USB memory device and uploaded to the machine via the USB interface.

5. A method of data communication with a PD machine, the method including: providing a USB interface that includes a USB port on the machine; uploading data that includes one or more patient-specific prescription records to the machine by: transferring the data to a USB memory device; and 9 inserting the USB memory device in the port; and using the one or more patient-specific prescription records to direct a sequence of operations on a PD cycler of the PD machine.

6. A method performed on a peritoneal dialysis (PD) machine including a source of PD solution and a PD cycler for routing and delivering the PD solution to a patient, the method including: receiving, via a USB port on the PD machine, a patient-specific prescription record from a USB memory device removably inserted into the USB port, the patient-specific prescription record comprising one or more treatment parameters transmitted by a physician by way of an electronic messaging system; directing a sequence of operations on the PD cycler based at least in part on the one or more treatment parameters to perform peritoneal dialysis on the patient; generating a treatment record based at least in part on the performed peritoneal dialysis; and transferring the treatment record to the USB memory device.

7. The method of claim 6, wherein the treatment record is configured to be attached to an electronic message and transmitted to a physician.

8. The method of claim 6, wherein at least a portion of data contained in the treatment record is usable by a physician to create a modified patient-specific prescription record.

9. The method of claim 6, wherein the one or more treatment records comprise a number of fills.

10. The method of claim 6, wherein the one or more treatment records comprise a volume of fills.

11. The peritoneal dialysis machine of claim 1, wherein the one or more patient specific prescription records comprise one or more of a user name, a user identification, and a user weight. 10

12. A peritoneal dialysis machine, comprising a source of PD solution, a PD cycler for routing and delivering the PD solution to a patient in need of peritoneal dialysis, a USB data communications interface including a USB port on the machine that accepts a USB flash drive, and a USB interface control system for managing the uploading and downloading peritoneal dialysis related data, wherein the data is in the form of a patient profile and prescription record provided by the user, the record being stored on the user's USB flash drive and uploaded to the machine via the USB interface , and a controller for directing the sequence of operations on the PD cycler to carry out peritoneal dialysis on the patient according to the uploaded patient profile and prescription record.

13. The peritoneal dialysis machine of claim 12, wherein the data is in the form of a digital record of therapy data from following a treatment, the data being downloaded onto the user's USB flash drive for transfer to a PC.

14. A method of data communication with a PD machine, comprising providing a USB interface including a USB port on the machine, uploading patient data to the machine by transferring patient data to a USB flash drive and inserting the user's USB flash drive in the port, wherein the data is in the form of a patient profile and prescription record provided by the user, the record being stored on the user's USB flash drive and uploaded to the machine via the USB interface, and directing the sequence of operations on the PD cycler to carry out peritoneal dialysis on a patient according to the uploaded patient profile and prescription record.

15. A peritoneal dialysis machine, comprising a source of PD solution, a PD cycler for routing and delivering the PD solution to a patient in need of peritoneal dialysis, a controller for directing the sequence of operations on the PD cycler to perform peritoneal dialysis on the patient, and a USB data communications interface including 11 a USB port on the machine that accepts a USB memory device, and a USB interface control system for managing retrieval of peritoneal dialysis related data from a USB memory device disposed in the USB port, the data comprising one or more patient-specific prescription records wherein the USB interface control system is configured to write, following a treatment, digital records of therapy data and error data onto the USB memory device for transfer to a personal computer, wherein the digital record of the error data includes at least one of error conditions and alarms, which are encountered during the operations on the PD cycler. 12