System and method for automated data collection of twenty-four hour ultrafiltration and other patient parameters using wired or wireless technology.

(54) Title: SYSTEM AND METHOD FOR AUTOMATED COLLECTION OF TWENTY-FOUR HOUR ULTRAFILTRATION DATA AND OTHER PARAMETERS OF THE PATIENT USING WIRED OR WIRELESS TECHNOLOGY.

(54) Title: SYSTEM AND METHOD FOR AUTOMATED DATA COLLECTION OF TWENTY-FOUR HOUR ULTRAFILTRATION AND OTHER PATIENT PARAMETERS USING WIRED OR WIRELESS TECHNOLOGY.

(57) Summary

A dialysis system that includes: a dialysis machine to perform a first dialysis session on a patient early in the day; a remote exchange apparatus for performing a second dialysis session on the patient at a second time of day, the remote exchange apparatus being configured to record an amount of ultrafiltration (UF) that is removed from the patient in the second dialysis session; and a communication link between the dialysis machine and the remote exchange apparatus, wherein the dialysis machine is configured to receive the recorded amount of UF removed from the remote exchange apparatus by means of a communication link and determine the total amount of UF removed from the patient in the first and second sessions.

(57) Abstract

A dialysis system ineludes: a dialysis machine for performing a first dialysis session on a patient at a first time of a day; a remóte exchange device for performing a second dialysis session on the patient at a second time of the day, the remóte exchange device configured to record an amount of ultrafiltration (UF) that is removed from the patient over the second dialysis session; and a communication link between the dialysis machine and the remóte exchange device, wherein the dialysis machine is configured to receive the recorded amount UF removed from the remóte exchange device via the communication link and determine a total amount of UF removed from the patient over the first and second sessions.

Institute

Mexican Property

Industrial

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THE

PATENT TITLE NO. 339688

Holder (s): BAXTER INTERNATIONAL INC .: BAXTER HEALTHCARE SA

Address: One Baxter Parkway, Deerfield, Illinois, 60015, USA

Name: AUTOMATED DATA COLLECTION SYSTEM AND METHOD OF PATIENT PARAMETERS USING WIRED OR WIRELESS TECHNOLOGY.

Classification: IC.8: A61M1 / 14; A61M1 / 28; G06F19 / 00

Inventor (s): ALEX ANP1NG YU, ROBERI Λ. GhILUERB, PETE HOPPING

REQUEST

Number: International filing date:

MX / a / 2015/001746 May 04, 2010

PRIORITY

Country: Date: Number:

US May 20, 2009 12 / 469,371

Validity: Twenty years

Expiration Date: May 4, 2030

The reference patent is granted based on articles 1, 2, section V, 6, section III, and 58 of the Industrial Property Law.

In accordance with article 23 of the Industrial Property Law, this patent has a validity of twenty non-extendable years, counted from the date of filing of the international application and will be subject to payment of the fee to keep it in force. rights.

Whoever subscribes to this title does so based on the provisions of articles 6 ”sections III and 7 ° bis 2 of the Industrial Property Law (Official Journal of the Federation (QOF) 08/27/1901 amended fa '02Ό8Ί994 25Ί0 / 1396 12/26/1987, 05/17/1999, 01/26/2004, 06/16/2005, 01/25/2006, 06/05/2009, 06/01/2010, 06/18/201 ( ., uo20'0 2 -0 '· 2012 and O' · 04/2012), articles 1 * 3 ° fraction V item a). 4th and 12th fractions I and III of the Regulation of the Mexican Institute of Industrial Property (DOF 12/14/1996, amended on 07/01/2002, 07/15/2004, 07/28/2084 and 07/09 / 2007); articles 1 ° 3 ° 4 »9 section V naso a) 16 sections I and III and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on Ϊ0 / 10/2002, 07/29/2004, 08/04/2004 and 09/13/2007); 1, 3 and S subsection a) of the Agreement that deputies in the Deputy General Dwectorss, Coordinator, Divtsenaiee Directors, Heads of Regional Offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

Issue Date: June 6, 2016

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AUTOMATED PATIENT PARAMETERS USING WIRED OR WIRELESS TECHNOLOGY

Field of the Invention

The present invention relates to the administration of medical fluids and in particular to the administration of a peritoneal dialysis fluid.

Background of the Invention

Due to illness or other causes, a person's kidney system may fail. In kidney failure of any cause, there are several physiological disorders. The balance of water, minerals and the excretion of the daily metabolic load is no longer possible in kidney failure. During kidney failure, the toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in the blood and tissues.

Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins, and excess water from the body that would otherwise have been removed through normal kidney function. Dialysis treatment for replacement of kidney functions is critical for many people because of

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INDUSTRIAL that the treatment is saving their lives. A person whose kidneys have failed could not go on living without replacing at least the filtering functions of the kidneys.

One type of dialysis is peritoneal dialysis. Peritoneal dialysis uses a dialysis solution, or "dialysate," which is infused into the patient's peritoneal cavity through a catheter implanted in the cavity. Dialysate contacts the patient's peritoneal membrane in the peritoneal cavity. Waste, toxins, and excess water pass from the patient's bloodstream through the peritoneal membrane and into the dialysate. The transfer of waste, toxins and water from the blood stream to the dialysate occurs due to diffusion and osmosis, that is, an osmotic gradient occurs in the membrane. The spent dialysate is drained from the patient's peritoneal cavity and removes waste, toxins, and excess water from the patient. This cycle repeats.

There are several types of peritoneal dialysis therapies, including ambulatory peritoneal dialysis (“CAPD”) and automatic peritoneal dialysis (“APD”). CAPD is a manual dialysis treatment, in which the patient connects an implanted catheter to a drain and allows the spent dialysate fluid to drain from the patient's peritoneal cavity. Then the patient connects the catheter to a bag

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of cold dialysate and manually infuse the fresh dialysate through the catheter and into the patient's peritoneal cavity. The patient disconnects the catheter from the fresh dialysate pouch and allows the dialysate to remain within the cavity to transfer waste, toxins, and excess water from the patient's blood stream to the dialysate solution. After a period of permanence, the patient repeats the manual dialysis procedure.

In CAPD, the patient performs several cycles of drainage, filling and permanence during the day, for example, approximately four times a day. Each treatment cycle generally takes about an hour. APD is similar to CAPD in that dialysis treatment includes a drain, fill, and stick cycle. However, APD machines perform three to four cycles of peritoneal dialysis treatment automatically, usually at night while the patient sleeps. As with CAPD, APD machines are fluidly connected to an implanted catheter, one or more fresh dialysate sources or bags, and fluid drainage.

APD machines pump fresh dialysate from the dialysate source, through the catheter, into the patient's peritoneal cavity and allow the dialysate to remain within the cavity so that transfer of waste, toxins, and excess water occurs of the current

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blood from the patient to the dialysate solution. APD machines then pump the spent dialysate from the peritoneal cavity through the catheter into the drain. APD machines are generally computer controlled so that dialysis treatment occurs automatically when the patient is connected to the dialysis machine, for example, when the patient sleeps. That is, the APD systems automatically and consecutively pump the fluid into the peritoneal cavity, allow a stay, pump the fluid out of the peritoneal cavity, and repeat the procedure. As with the manual process, several drain, fill, and dwell cycles will occur during APD. A "last fill" is generally used at the end of the APD, which remains in the patient's peritoneal cavity when the patient disconnects from the dialysis machine for the day.

Some patients do a mid-day exchange for the APD machine. The patient has to manually track the amount of ultrafiltration (“UF”) removed during a half-day exchange and then add it to the amount of UF removed using the APD machine (usually overnight) to arrive at a total UF amount daily or twenty-four hours. There is a need for improvement for this current practice. Furthermore, there is a need for an APD machine to conveniently accept and monitor other relevant patient parameters for an

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INDUSTRIAL dialysis therapy so that the patient's blood pressure and weight can then be used to help obtain better therapy.

Brief Description of the Invention

The present disclosure provides a dialysis system and method for recording twenty-four hour automatic ultrafiltration ("UF) and patient data using wired or wireless technology. The present description is described in relation to peritoneal dialysis ("PD), however, many concepts established herein are applicable to other medical fluid treatments and in particular other types of renal failure therapies such as hemodialysis (" HD "), haemofiltration ("HF") and haemodiafiltration ("HDF").

In a primary embodiment, the current system and method include a dialysis machine, such as an automatic peritoneal dialysis machine ("APD") and a remote exchange apparatus ("RED"). The APD machine generally operates a night therapy in which the machine operates by conducting the spent fluid from the patient's peritoneum and then filling the patient with fresh dialysate. That fresh dialysate remains inside the patient for a period of time (a period of permanence), absorbing toxins and UF (basically the accumulated fluid that the patient cannot excrete) until the fresh dialysate is used up. APD machines repeat in previous cycle a number of vec s,

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such as three to five times, each cycle accumulates additional UF, which is recorded by the APD machine.

In addition to night therapy, many PD patients can perform an additional half-day exchange that also removes toxins from a patient's UF. The initial night drain will then be the half day fill spent. The half-day exchange is carried out using RED, which also accumulates the amount of UF produced by the patient. In the method and system of the present description, the amount of UF accumulated through the half-day exchange is communicated to the APD machine, which totals the UF removed for a full day or a treatment of twenty-four hours, removing the load the patient to do it manually.

In one mode, the RED approaches the APD machine, so the RED can send information to the machine. Communication can be via a cable that is attached between the RED and the APD machine, such as a USB cable or serial cable. Alternatively, communication is wireless, for example, via Bluetooth, Zigbee, WiF, or a wireless USB memory stick.

In another embodiment, the system includes an intermediate data transfer unit. The RED downloads the therapy information to the data transfer unit through the wired or wireless communication of the same

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INDUSTRIAL in a similar way or to the direct communication modality explained above. The data transfer unit includes a memory storage element port, such as a USB port, which allows the patient to insert a memory storage element, such as a USB flash drive or travel unit, into the port. The relevant data is then downloaded from the data transfer unit to the storage element, which is then brought to the APD machine. The APD machine is provided with processing and memory to integrate the half-day data with the night data to arrive at the twenty-four hour data, for example, the removed twenty-four hour UF.

The intermediate data transfer unit is useful when there are multiple APD machines in the system, for example for an application within a center. In this case, the data transfer unit operates with multiple RED for different patients. Each patient is provided with their own item or memory storage card. The patient downloads the data from the RED to the data transfer unit and inserts his memory card into the unit. The unit can search for a patient identifier so that it can enter information for multiple patients while waiting to receive a memory card. At the time of receiving the identifier, which for example, coincides with a

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INDUSTRIAL -identifier sent from the RED together with the therapy data, the appropriate data is downloaded to the card or patient data element, which can then bring the patient to the APD machine to download the data within the machine. In an alternative embodiment, the data transfer unit waits until the above data is downloaded from the patient's data card before accepting the data from a second machine. Even in this case, it is desirable to require identification of the patient so that the system and method can confirm that the data is being downloaded to the appropriate data transfer card.

In a further alternative modality, the RED is provided with a port to receive the card or the patient data element. Patient identification may or may not be required to download RED data on the patient data card.

The system and method do not require an Intermediate data transfer unit to operate multiple machines, for example, in one center. The patient's RED can be wired directly to the machine that stores the patient's night therapy data. In this case, the Patient Identification code may be required to ensure that the APD machine is being linked to the appropriate RED. When communication is done Wirelessly, the

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system may require one or both of (i) encryption which initiates security features before wireless link between APD machine and RED is terminated and (ii) a patient identifier confirming that RED is linked to the correct machine.

It is contemplated for any of the modalities described herein to provide data transfer from different peripheral devices to and in addition to RED. Communication may be wired but is in a preferred mode, wireless, to avoid multiple cables. In addition to RED, the APD machine may be configured to read any one or more of: (i) bioelectrical impedance data (which measures the hydration condition of the patient's fluid and calculates the patient's dry weight); (ii) the blood pressure data (eg, a blood pressure cuff); (iii) body weight (for example, from a scale); (iv) the patient's blood glucose data (eg, from a glucometer); and the patient's body temperature (for example, from a thermometer). Each of the above devices is modified in a mode to be a wireless data master, so that the APD cycler is then a wireless data slave. The result is a wireless network in which any of the peripheral master devices can send information to the APD machine (assuming that the

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encryption and / or identifier security measures) when the APD machine is visible to others or in a discoverable way.

Accordingly, it is an advantage of the present disclosure to provide a method and system for automatically calculating and monitoring the twenty-four hour ultrafiltration removed from the patient.

Another advantage of the present disclosure is that it provides a method and system that automatically receives multiple patient parameters relevant to therapy, such as patient weight, blood pressure, glucose level, temperature, and bioimpedance hydration data.

It is a further advantage of the present disclosure to provide a system and method that can be expanded to comprise multiple machines, for example for use in a facility.

Still another advantage of the method and system of the present disclosure is to use wireless technology in an embodiment for automatic data exchange.

Additional features and benefits are described here, and may be appreciated from the following Detailed Description and figures.

Brief Description of Drawings

Figure 1 is a perspective view of one embodiment of an automatic pitoneal dialysis machine ("APD"), and in

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In particular, a peritoneal dialysis machine used to carry out a night dialysis treatment.

Figure 2 is a schematic view of one embodiment of a remote exchange apparatus ("RED") used to perform a half day exchange for the patient.

Figure 3 is a schematic view of an embodiment of the system and method that accompanies the present description.

Figure 4 is a schematic view of a second embodiment of the system and method that accompanies the present description.

Figure 5 is a schematic view of a third embodiment of the system and method that accompanies the present description.

Figure 6 is a schematic view of a fourth embodiment of the system and method that accompanies it of the present description.

Figure 7 is a logical flow diagram illustrating a method of coupling a peripheral parameter sensing apparatus with an APD machine.

Fig. 8 is a sample display screen of an embodiment of the APD machine of the present disclosure, showing the wirelessly read weight and blood pressure of peripheral devices.

Fig. 9 is a sample display screen of one embodiment of the APD machine herein.

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_F ΜΙΚξΛΙηΜΙΚξΛΙ description, which shows the voltage of the supply batteryof the scale, which is the Bluetooth Address and reading the Serial Number wirelessly from a scale.

FIG. 10 is a sample display screen of an APD machine embodiment of the present disclosure, showing the patient's weight, measurement data from the peripheral scale, and wireless date and time reading from the scale.

Fig. 11 is a sample display screen of an embodiment of the APD machine of the present disclosure, showing the voltage of the blood pressure cuff supply battery, and its Bluetooth Address read wirelessly from the pressure cuff.

FIG. 12 is a sample display screen of one embodiment of the APD machine of the present disclosure, showing the patient's systolic and diastolic blood pressure, pulse, and blood pressure m-day ("MAP") read wirelessly from the pressure cuff. Detailed description of the invention

Dialysis Machine

Referring now to the drawings and in particular to Figure 1, the data collection system 100 uses a dialysis machine 10. System 100 can generally be applied to any type of kidney failure therapy system, such as dialysis periton al (“PD), hemodialysis (“ HD ”),

MEXICAN INSTITUTE OF PROPERTY h mofiltration (“HF”), hemodiafiltration (“HDF”) and continuous renal replacement therapy (“CRRT). The ΪΰΟ system could also be used outside the renal field, such as for the administration of drugs in general and for blood processing. However, for ease of illustration, system 100 is generally described as a dialysis system, and in one application particularly well-suited as a PD system.

Dialysis instrument 10 is configured for any type of kidney failure therapy system that is used. Dialysis instrument 10 includes a central processing unit ("CPU") and a plurality of controllers (eg, safety controllers, valves, heater, pump, video and audio (eg, voice guidance)) that can be operate with the CPU. The CPU operates with a user graphing machine interface (“GUI”), for example, via a video controller. The GUI includes a video monitor 20 and one or more types of input devices 22, such as a contact screen or an electromechanical input device (eg, a membrane switch). The CPU also operates with a wireless communicator 15 and / or receives data from the memory device port 25, such as a USB flash drive or travel unit port, which will be explained in more detail later.

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CPU and video controller in cooperation'IFWlh ef⁵¹—— video monitor 20 provide the UF and offlJS · ~ ™ data ”· -¾ download instructions visually by means of characters / graphics to the patient or caregiver. For example, the characters / graphics may be displayed to provide instructions regarding when to attempt to send the data wirelessly to machine 10 or where a machine 10 to connect an instant unit for data download. Additionally or alternatively, the CPU and the voice guide controller in cooperation with the speakers 24 provide instructions that can be heard by voice guidance to the patient or caregiver. For example, voice guidance may be provided to give instructions regarding downloading data from a remote exchange device ("RED") (Figure 2) to machine 10.

As can be seen in Figure 1, the dialysis instrument 10 accepts and operates with a disposable apparatus 30. Disposable apparatus 30 includes one or more supply bags 32a to 32c (referred to collectively in this description as supply bags 32 or individually, generally as a supply bag 32). Although the three supply bags 32 are shown, system 10 can employ any suitable number of supply bags. Disposable set 30 also includes a drain bag (not shown), a bag

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heater 36, bag tubes 38a through 38d (referred to collectively as tubing or tubes 38 or individually, generally tube 38) and a disposable pump / valve cassette (not shown).

Depending on the type and structure of machine 10, one or more items of disposable apparatus 30 may not be necessary. For example, machine 10 may pump spent fluid into the house drain, such as a bathtub, toilet, or toilet. laundry room, instead of a drainage bag. Machine 10 may also include an in-line heater, in which case heater bag 36 is not required.

As mentioned, a disposable cassette (located behind door 16 of machine 10 in Figure 1) connects to supply bag 32, a drain bag, and a heater bag 36 via tubes 38a, 38b, and 38c. , respectively. Tube 38d runs from the cassette to a patient connection 44. The cassette in one embodiment includes a rigid structure having (i) rigid outer walls, (ii) a base wall from which the inner pump chambers, valve chambers, and interior fluid paths extend, (¡Ii) rigid fluid ports connecting so as to seal the pipe 38, and (¡v) a pair of flexible membranes or sheets sealed to the outer rigid walls and possibly additionally to the inner rigid walls. Pipe 38 can be attached to a port,

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so bags 32 are nailed for fluid connection. Alternatively, tubing 38 is attached to bags 32 and the cassette ports are nailed for fluid connection.

Machine 10 can drive the pump and cassette valve chambers pneumatically, mechanically, or both. The illustrated mode uses a pneumatic drive. The HomeChoice® APD system marketed by the assignee of the present disclosure uses a pneumatic system described in US Patent No. 5,350,357 ("Patent * 357), the entire content of which is incorporated herein by reference. In this case, machine 10 includes a membrane gasket, which creates different areas sealed with the cassette cover in each of the pump chambers and the cassette valve. Machine 10 in the illustrated embodiment includes a door 16, which closes against the cassette. Door 16 includes a pressure plate (not shown), which can be operated mechanically (for example, by closing the door) and / or pneumatically (for example, by means of an inflatable bladder located at the door behind the pressure plate). Pressing the plate against the cassette simultaneously presses the cassette against the membrane gasket that cooperates with the cassette cover to pump fluid and open and close valves.

US Patent No. 6,814,547 (“the Patent

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'547 ") assigned to the assignee of the present disclosure, describes a pumping mechanism in relation to Figures 17A and 17B, incorporated herein by reference, which uses a combination of pneumatic and mechanical actuation. Figures 15, 16A and 16B of the '547 Patent, incorporated by reference to the present disclosure, teach the use of mechanically actuated valves.

Either or both of the pumping mechanism and valves of the '547 patent could alternatively be used with machine 10.

Remote Exchange Device ("RED")

A suitable embodiment for a remote exchange apparatus ("RED") 50 is described in North American Patent Application No. 12 / 131,755 ("the '755 Application"), filed on June 2, 2008, titled Remote Exchange Peritoneal Dialysis ”, The full content of which is incorporated herein by reference directly. The control scheme for the embedded device is illustrated here in Figure 2, which is adapted from Figure 2 of the '755 Application. FIG. 2 illustrates a control system for a flexible, portable RED 50. The control system receives conventional electrical power from an electrical cord 62 that is suitable for normal AC power from the home, clinic, or hospital. The primary user of energy in this system is the heater. Thus, as shown, the nergy

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input is sent to power supply 64 for conversion to the particular energy needed for the heater. The power supply also produces five VDC power for the microcontroller system 66 and the other system components, as needed such as for the LED bulbs. Other voltages can be produced by power supply 64 as needed for each component of the system. The microcontroller receives a number of inputs from system components, such as the temperature selector, and if used, an input and output to a separate heater controller. Microcontroller 66 may itself include a routine for controlling the heater instead of using a separate heater controller. The temperature sensing element, or temperature sensor, such as the thermocouple or thermistor, is used to measure the temperature of the dialysis fluid and to control the heating of the dialysis fluid. A pressure sensor can also be placed at one or more points within the system to calibrate the fluid pressure to and from the patient. In particular, a vacuum gauge, or an absolute pressure gauge, can be placed in the drain line to avoid using too much suction in the drain line, which could irritate the patient's peritoneum.

The control system also accepts inputs from a load cell 76 on the RED 50 and keyboard 68, or

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY optionally, a keyboard. The control system also includes a number of outputs. A monitor 70, such as a video display or a digital readout, can be used to produce the dialysate temperature, elapsed time, and so on. Other outputs include signals to vacuum pump 72 or dialysate pump 74, which may be a peristaltic pump, a membrane pump, or another desired pump. The system also includes the signal processing circuit system and a wireless communicator 80. The signal processing circuit system of the control system 60 and the wireless communicator 80 are small and compact and fit well within the control system of the RED 50.

A suitable wireless module for the communicator 80 is the ZigBee / IEEE 805.15.4 module. This is a standard for a very low power radio system with a very limited range, from approximately 10 to 20 feet (304.8 to 609.6 cm). The module made in accordance with the standard can be purchased from Maxstream, Inc., Lindon, UT, USA, Helicomm, Inc., Carlsbad, CA, USA, and ANT, Cochrane, Alberta, Canada. The module is very small, and can be approximately 2 cm square (approximately 1 square inch), and approximately 3 mm thick (1/8 inch). The signal processing circuit system formats the digital data and routes it to a data buffer before ΐΜΡΙ ~

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transmission to a remote site. Other equipment according to the specifications can be used instead of it, such as "IEEE 802.15.1 (" Bluetooth "). Alternatively, the microprocessor can report the desired therapy information by means of a remaining line such as a wire harness connected to the appropriate site for receiving the information, such as a communications center of a hospital or clinic.

The system can sound an alarm if the therapy parameters are exceeded through horn 82 or by lighting one or more LEDs on RED 50. An alarm can also be raised through monitor 70 in conjunction with stopping the session of therapy. The controller can use the outputs by sending a signal to the appropriate output when the temperature of the hot dialysate fluid is too high or too low, and when the therapy session has taken too long, or when any required parameter has been exceeded.

Data Transfer from RED 50 and Other Peripherals to the

APD 10 machine

The APD 100 machine records the ultrafiltrate (“UF”) removed by night exchanges automatically. Until now, however, the patient had manually weighed the day's exchange fill volume and drained volume using the scale and manually entering these values ​​into an APD machine. Referring to Figure 3, system 100a automates data collection from

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UF and other values, which include both the vwftWMis

Night exchange like half day. oiotoina 100j · adds the UF Night Exchange and the UF Half-Day Exchange to reach a total daily UF. System 100a (and the other systems) allow half-day exchanges to be conducted away from the patient's home and without using the APD 10 machine.

The RED 50 provides the Half Day Exchange and the ability to record fill volume and drain volume to calculate UF for one or more half day exchanges. The RED 50 uses a wireless communicator 80 to communicate with the wireless communicator 15 of the APD machine 10. The wireless communicator 80 has a transmit function and alternatively additionally has a receive functionality to receive information, for example, from the APD machine 10. The wireless communicator 15 from the APD machine 10 has receive functionality and so Alternatively, it also has transmission functionality to send the data, for example, to the RED 50.

It is contemplated with system 100a that the patient's return home, for example, from work, and a place of RED 50 within the communication range of wireless communicators 15 and 80. When both the APD machine 10 and I RED 50 are energized then, the UF data is

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downloaded from the RED 50 to the APD 10 machine. The download can be automatic or require user input from any of the input devices 22 of the machine 10 or through the RED 68 keyboard 68. Appropriate information regarding discharge of UF data, such as fill volume amount, drain volume amount, and resulting UF can be displayed on one or both of the machine's video monitors 20 10 and RED 70 monitor 70. The calculation of the UF is removed for the half-day exchange (total half-day drained volume minus the total half-day fill volume) can be performed by means of RED 50 microcontroller 60 or by machine CPU 10 The daily or twenty-four hour general UF removed (the total night UF and the half day UF) is performed on the CPU of machine 10 in one mode. In this way, the best therapy, for example PD therapy is provided because critical data is automatically recorded, transferred, and manipulated, removing the recording and calculating errors, and making therapy easier for the patient.

Figure 3 shows that the APD machine 10 can accept other data wirelessly and is not limited to remotely receiving the UF data from the RED 50 half-day exchange. For example, the APD 10 cycler can additionally receive the impedance analysis data bioelectric

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INDUSTRIAL ("BIA") wirelessly from a matched BIA device with a wireless communicator, such as communicator 80. The APD 10 cycler can wirelessly receive blood pressure ("BP") blood pressure data or a matched monitor with a wireless communicator, such as communicator 80. The same holds for the patient's weight by means of the scale (“WS”), the glucose data (“G”) of a glucometer or the patient's temperature data (“T”) of a thermometer, each one matched with a wireless communicator, such as communicator 80.

The APD machine 10, in general, uses each of the different UF, BIA, WS, BP, G and T data to evaluate a running or finished therapy. The machine can receive any one or a combination of the UF, BIA, WS,

BP, G and T. Also, the different data does not have to come from each of a separate device. For example, a single unit that measures data ΒΙΑ, T, G, and possibly BP could be used with the RED 50 for the UF and a separate scale for the WS. Or, such a device could be combined with RED 50.

In an alternative embodiment, any of the RED 50, BIA, BP, WS, G and T devices can communicate via wired communication with APD machine 10. In this case, machine 10 and the associated device accept each one a cable, for example, for serial or USB communication.

Referring now to Figure 4, system 100b

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illustrates an alternative system that mpl to an intermediate data transfer unit ("DTU) 90. DTU 90 receives any or more of the UF, DIA, BP, WS, G and T data by wire or wireless via of the apparatus and methodology described here. The DTU 90 also has a port 25 to accept a memory device 85, for example, a USB serial drive or flash drive, which plugs into port 25. Information sent wirelessly to the

DTU 90 is transferred to unit 85 which is then connected to memory port 25 in APD machine 10. APD machine 10 then retrieves data from memory device 85.

Figure 4 shows another alternative means of UF data that can be transferred from RED 50 to APD machine 10. In this case, RED 50 is also provided with a memory device port 25 that can accept a memory device 85 to obtain the exchange data for the half-day UF. Memory device 85 is then brought to APD machine 10 and is connected within port 25 of machine 10 to download the UF information into the machine.

Figures 5 and 6 illustrate systems 100c and 100d, respectively, that are used when multiple APD machines are located in the same environment, eg, multiple machines in a center. In a center of

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Dialysis or hospital MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY, multiple APD 10 machines may treat multiple patients at the same time. The system 100c of FIG. 5 illustrates the machines 10a and 10b, and each of which has its own RED 50, ΒΙΑ, BP, WS, G and T devices, which communicate wirelessly or via communication. wired with APD 10a or 10b machines. The following describes the encryption and security technologies that prevent cross-communication between peripheral devices that communicate wirelessly with the correct APD 10 machine.

Figure 6 illustrates three APD machines 10a through 10c. In this case, the DTU 90 described above is used again. Each machine has its own memory device 85. The DTU 90 consecutively receives data from one or more of the RED 50, BIA, BP, WS, G and T devices for a patient, transfers the information to the patient memory device 85, which is then taken for the appropriate APD machines 10a through 10c. DTU 90 then receives data for the next patient and so on. The DTU 90 may require a username and password to enable the received data to be downloaded to a memory device 85. In one embodiment, the DTU 90 includes an input device 92 that when pressed cleans the memory within the DTU 90 and makes it possible for the memory to then fetch new data for any one or more of

<img file="MX339688B_D0022.tif" />

MEXICAN INSTITUTE Ι &amp; Αμϊ- »¹OF PROPERTY \ S, data UF, ΒΙΑ, BP, WS, G and T for a new ^ éi ^ hte? '-²* * It should be appreciated that the system 100d of FIG. 6 e11ΙΠIna- the cross-communication problems of the system 100a of FIG. 5.

Bluetooth wireless technology is a preferred technology and has three classes of ranges shown below in Table 1. Classes I and II may be more suitable for the operations described.

<td>Class</td><td>Maximum Permitted Power</td><td>Range (Approximate)</td>

<td>Class i</td><td>100mW</td><td>~ 100 meters</td>

<td>Class II</td><td>2.5 mW</td><td>~ 10 meters</td>

<td>Class III</td><td>1.0 mW</td><td>~ 1 meter</td>

The Bluetooth data index is shown in Table 2 below. System 100 (including the entire system 100a to 100d) can use either version 1.2 or 2.0.

<td>Bluetooth version</td><td>Data Range</td>

<td>Version 1.2</td><td>1 Mbps</td>

<td>Version 2.0</td><td>3 Mbps</td>

In any of the modalities described herein, when wireless communication is used, a network can be formed and used. For example, if Bluetooth wireless technology is used, a topology of

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MEXICAN INSTITUTE D € THE PROPERTY

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<img file="MX339688B_D0023.tif" />

star between the APD machine 10 and the peripheral device, such as the RED 50. In the resulting piconet, the peripheral device operates as the master, while the APD machine 10 operates as a delegated device. When the patient wants to download data to the APD machine 10, the APD machine makes itself "visible to others. That is, the APD machine 10 places itself in a discoverable mode in which it can be "discovered" by or communicated with any of the master peripheral devices, such as the RED 50, aparatos, BP devices. , WS, G and T.

It is contemplated that any of the RED 50, BIA, BP, WS, G and T devices will disconnect themselves once they have communicated their data to the APD 10 machine. If any of the devices have the battery powered, for example, devices BIA, BP, WS, G and T, the disconnection will save the battery charge.

Referring to Figure 7, method 150 illustrates a possible means in which one of the peripheral devices becomes coupled, or enabled for communication, with an APD machine 10. Method 150 uses the BP as an example. but it also applies to other types of peripheral devices. Once the pairing is complete, the APD machine 10 stores the address of the peripheral device and the corresponding patient identification number ("PIN") in its non-volatile memory. In a similar way,

<img file="MX339688B_D0024.tif" />

Peripheral devices, for example, the BP device, stores the wireless or Bluetooth address of the APD machine 10 in its non-volatile memory. In this way, the pairing process only has to be performed once on the APD machine and any particular peripheral apparatus.

At circle 152, coupling sequence 150 begins. At block 154, APD machine 10 is turned on and set to wireless mode which can be found to be "visible to others." At block 156, the patient uses the BP apparatus to take a blood pressure measurement. In block 158, method 150 waits until the request for the wireless or Bluetooth PIN code appears on the video monitor 20 of the APD machine 10 (or on the computer linked to the APD machine). In block 160, the patient or caregiver enters the BP PIN number in the CPU of APD machine 10 via input device 22 or a computer linked to APD machine 10. In block 162, method 150 awaits authorization for wireless or Bluetooth service. In general, authentication causes confirmation of a unique address of a Wireless Bluetooth device (for example, a forty-eight unique address for the world), and the user enters the security PIN. The APD machine may also require verification of the patient's name or identification.

The patient or caregiver then presses OK or confirms

<img file="MX339688B_D0025.tif" />

MEXICAN INSTITUTE OF INDUSTRIAL MONEDAD to allow additional action. At block 164, the patient or caregiver selects an option to keep the APD machine 10 and BP apparatus connected in the future. This may result in the review "always allows the device to access this service" on a computer screen linked to the APD machine or a video monitor 20 of the APD machine 10.

Patient safety is a priority for System 100. It is important that the APD machine 10 receives the correct data for a particular patient. It is also important that others cannot access patient data without authorization. With respect to the latter matter, it is contemplated to use proprietary protocols for communication between peripheral devices and the APD machine 10. Protocols require the machine to maintain custom software in order to receive and process information from peripheral devices. The software prevents a third party from having the PIN number and the Bluetooth address of the APD machine 10 intercept the patient information that is being sent from a remote device.

Wireless technology, for example Bluetooth, can operate in the following security modes:

<img file="MX339688B_D0026.tif" />

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<td>Security Mode 1:</td><td>Without authentication or encryption - i- ·· ........ .</td>

<td>Security Mode 2:</td><td>Security was not started on the Bluetooth link, or link establishment. Instead security is enforced at connection level setting (i.e. SDP, RFCOMM)</td>

<td>Security Mode 3:</td><td>The initial security procedures before the preparation link is complete. Two different security policies are possible: always require authentication or always require both authentication and encryption.</td>

The inventors recommend security mode three for communication between any of the RED 50, ΒΙΑ, BP, WS, T and G devices and the APD machine. Authentication comprises the PIN and address described above. Encryption includes: (i) the unique number of the wireless device and the number of the security PIN (integrated in the original Bluetooth wireless blood pressure or scale device); (I) 64, 128, 192, or 256-bit encryption (Originally purchased Bluetooth wireless blood pressure and scale devices from A&amp;D have 128-bit encryption); and (iii) owner's communication protocol. As will be shown later, the prototype was successfully developed using the owner's communication protocol and the blood pressure and scale data was transferred to the target devices.

Generally, the prototype software for interfacing with wireless peripherals was built for the interface PC (Windows XP) and the HP IPAQ PDA (Mod lo HX2795, using Windows Mobile). The

<img file="MX339688B_D0027.tif" />

INSTITUTO MEXICANO DB LA PROPIEDAD inventors developed the prototype to make ¡nteWW #¹ col scale and inert blood pressure devices »lllL&gt; 11CUS 'sold by A&amp;D Medical, San José, California. The prototype has been run on Windows XP using a laptop or Windows Moblle 5.0 using an HP iPAQ PDA. The A&amp;D Medical Bluetooth BP and WS use a level security link and a 128 bit encryption. The prototype development tools and equipment in the example included the prototype software:

software tools:

(i) Visual Studio 2005 Professional with Compact Framework 2.0; and (¡i) Windows Mobile 5.0 SDK installed on top of the Compact Framework:

Hardware Tools:

(i) A&amp;D Medical Blood Pressure Cuff;

(ii) A&amp;D Medical Scale;

(¡II) Bluetooth enabled system (eg HP Compaq nc6220 with Bluetooth features);

(iv) Bluetooth Dongle (Klnsington, Bluetooth 2.0, potential link for up to seven devices within a range of sixty-five feet (1981.2 cm); and (v) HP iPAQ, Model HX2795b, ARM920T PXA27x processor, Microsoft Windows Mobile Version 5.0 .

The Bluetooth prototype application was developed n

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<img file="MX339688B_D0028.tif" />

the Visual Studio 2005 platform using the C # programming language (Sharp C). A&amp;D medical devices followed by the Bluetooth Serial Port Profile, so that once the connection is established, the data is sent as in the serial port emulation.

After the BP or WS reading is taken, the apparatus searches for computers that can discover the Bluetooth / PDAs (for example, machine 10) and begins the questionnaire procedure. A standard PIN is stored in the peripheral device. Once the PIN request is obtained, the user responds by entering the correct PIN number, and wireless communication is created. After the pairing process is complete, the peripheral devices BP and WS store the address of the access point of the machine 10 to which it is connected for the next reading. The data in the future is then transferred to the address of the access point of the machine 10 stored by default.

The Microsoft NET Framework 2.0 has an integrated Serial Port class. The Serial port class can be used to open the Port on which the data is received. The received data is decoded and displayed on the screen. The software prototype works on top of the Bluetooth architecture layers, at the high level 25 application layer connected to the emulated serial port.

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<img file="MX339688B_D0029.tif" />

A first prototype application software was developed for the Windows XP environment. The first prototype software required the user to enter the serial port number of the computer or machine 10, which is used for communication. Once the reading is taken, the peripheral device (for example, the BP bracelet or the scale) searches for the address of the stored access point and transmits the data when the address is found. When the port of the computer or machine 10 is opened at the application end and receives the data, it unpacks the data and sends it back to the BP or WS peripheral device for acknowledgment. Figure 8 shows an example screen of that prototype software deployed. The display shows information such as date and time measurement, transmission date and time, device address, and serial number. There is also an option to calibrate a watch located within the peripheral device, for example, the A&amp;D Bluetooth peripheral device (for example, the BP or WS bracelet) having a communication protocol that uses a configuration package that allows the PIN to be changed and the clock is synchronized. The clock includes the year, month, day, hour, minutes, and seconds.

The first prototype used the Windows Mobile 5.0 SDK software, which provides a compact operating system combined with a suite of basic applications for i »1 9

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Of. THE FFOF1EDAD '^ a_K53a¿J8¿ mobile devices based on the program interface oVoV)¹!) the Microsoft Win32 application (“API”). The iTS programming interface for Microsoft applications provides functions, libraries, communication protocols, structures, and data classes to support custom build applications. Gadgets running Windows Mobile ™ software include, for example, pocket PCs, smartphones, and portable media centers. Windows Mobile ™ software is somewhat similar to desktop versions of Windows.

The Windows CE ™ software, also used in the original prototype software, is Microsoft's embedded real-time operating system, which is used for a wide variety of small footprint devices, including industrial controllers, communications masses, computer terminals point of sale, and consumer electronic components. The Windows Mobile ™ platform is built on top of Windows CE ™ software and concentrates the specifications on the lowest level operating system (“OS”), such as kernel, memory management, operator architecture, etc.

The original prototype software also used a Visual Studio 2005 platform provided with emulators, which resemble a Windows Mobile 5.0 device. The prototype software has been tested on the Pocket PC Mulator

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<img file="MX339688B_D0030.tif" />

Windows Mobile 5.0. Because the serial ports are used, the emulator's serial port is set to "listen to the communications port of the computer or machine 10, at which point the computer or machine listens. In the Emulator Configuration option, Serle Port 0 was mapped to the appropriate port number.

Figure 9 illustrates a screenshot showing the scale's internal battery voltage, Bluetooth address, and the scale's serial number. All of this data has been sent wirelessly from the scale to a computer or machine 10.

Figure 10 illustrates a screenshot showing the results of body weight, date and time measurement, and transmission date and time. All of this data has been wirelessly sent from a scale to a computer or machine 10.

Figure 11 illustrates a screenshot showing the date and time of the blood pressure measurement, the date and time of the transmission, the voltage of the internal battery, the Bluetooth address and the serial number. This information is transmitted by a peripheral blood pressure apparatus along with the pressures and pulses to a computer or machine 10.

Figure 12 illustrates a screenshot showing the results of the prototype for a pressure measurement.

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Blood: for example, systolic blood pressure, blood dlastolic pressure, pulse, and average arterial ΡΓδέιοη (“MAP”). All of this data has been sent wirelessly from a blood pressure cuff or device to a computer or machine 10.

In an alternative mode, the application is executed using a personal digital assistant ("PDA"), which at the same time communicates wirelessly or by means of wired communication with the machine 10. In the prototype, the PDA could already simulate be it the APD 10 machine or a real PDA used by a doctor in a dialysis center. Many current PDAs that have Bluetooth wireless communication capabilities that allow the custom prototype application to be loaded within the PDA, allow the modified PDA prototype to communicate wirelessly with wireless peripheral devices after pairing. The peripheral devices are again coupled using the NIP procedure. The application that is created in the emulator is Installed on the PDA. A process for creating PDA application software to interface with the dialysis machine 10 and one or more peripheral devices wirelessly is as follows:

(i) add a project and select a CAM project from an Intelligent Device in Microsoft Visual Studlo;

(il) after the project is created, in the design of the

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INSTITUTO MEXICANO DE LA mOREDAD project (in the project explorer, the user 'fW' ^ Sue select a design view or ··· clast! View, μ &lt;· ΓΠ5 ST

<img file="MX339688B_D0031.tif" />

prototype that selects the design view) under the applications folder, a right click and select "Add Primary Output" and select the "Application Project";

(iii) create a short circuit of the Start menu, Right click on “File System in Target Machine” and select “Add Special Folder” and under that selection, the Start Menu folder;

(iv) right click on "Start Menu Folder" and "Add Project Output" in the same way, right click on "Primary Output" and select the first option "Create Short Circuit ..." after which it is created a short circuit and you can define a suitable name for the short circuit;

(v) once the Project is built, a CAB file is created under the repository / debug folder;

(vi) the mobile device is synchronized to a computer or machine 10, and the CAB file is stored in the Device's file system; and (vii) double click on the CAB file on the PDA and the application will be installed.

The software for the Bluetooth prototype application for Windows XP on the PC and Windows Mobile 5.0 on the PDA has been successfully developed and tested. The conclusions and recommendations for the prototype are in the following list

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<img file="MX339688B_D0032.tif" />

(i) Wireless peripheral devices, such as —he— scale and A&amp;D blood pressure cuff, can be successfully paired with a Bluetooth enabled PDA / PC device, especially if the Bluetooth environment is calm.

(ii) The data transfer has been successfully performed in both a noisy and quiet Bluetooth environment once it is paired with the target PDA / PC (machine 1 0).

(iii) In a noisy Bluetooth environment (for example, other Bluetooth devices such as a cell phone, GPS receiver, laptop, other A&amp;D scales are on and in an active range), the scale and the BP bracelet They have attempted to dock with the first available device, which has sometimes not been machine 10 or PDA attempted. This effect is probably the result of the BP scale or bracelet being the "master" device on the Bluetooth Picor rather than the "delegated" device. If the PDA / PC machine (machine 10) has instead been configured as the "master", the machine could have searched and collected the specific devices desired to create a Bluetooth coupling. Peripheral instruments when configured to be the "master" communicator are therefore better paired with machine 10 in a "quiet" Bluetooth environment.

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY (iv) Peripheral devices have been able to successfully transfer data over the distance of approximately eighty feet (2438.4 cm). It has been found that the transmission distance will depend on the transmission medium between the two devices. Moving around a corner and placing an obstruction for wireless transmissions in the path between peripheral devices and machine 10 have been found to hinder successful data transmission.

(v) During initial coupling, the target instrument

10 It can be adjusted so that all Bluetooth peripheral devices can be discovered and allowed to communicate with the instrument. After pairing, it may be useful to set instrument 10 to communicate only with paired devices.

It should be understood that those skilled in the art will encounter various changes and modifications to the preferred modalities currently described in this document. Such changes and modifications can be made without departing from the spirit and scope of the present matter and without diminishing its intended advantages. Therefore, all such changes and modifications are intended to be covered by the appended claims.

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