Uploading data from an isolated system without compromising isolation

Abstract

A data transfer apparatus ("DTA") connects to a field generator in a TTFields therapy system using the same connector on the field generator that is used to connect a transducer interface to the field generator. The field generator automatically determines whether a transducer interface or a DTA is connected to it. When a transducer interface is connected to the field generator, the field generator operates to deliver TTFields therapy to a patient. On the other hand, when a DTA is connected to the field generator, the field generator transfers patient treatment data to the DTA, and the DTA accepts the data from the field generator. After the field generator has been disconnected from the DTA, the DTA transmits the data to a remote server, e.g., via the Internet or via cellular data transmission.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application 62 / 835,147, filed April 17, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] Generally, this application relates to uploading data from an isolated medical device without compromising the isolation of the medical device. More specifically, this application relates to a data transmission device (“DTA”) for use with a medical device, which facilitates remote monitoring of treatment using the medical device. Background Technology

[0004] Generally, TTFields (Therapeutic Fields for Tumors) therapy is a proven method for treating tumors. In the prior art Optune® system for delivering TTFields, as illustrated in Figure 1, TTFields are delivered to the patient via four transducer arrays 10 placed close to the tumor on the patient's skin. The transducer arrays 10 are arranged in two pairs, and each transducer array 10 is connected to a transducer interface 20 via a multi-wire cable, which in turn is connected to a field generator 14 via a connector. The field generator 14 (a) sends an AC current through one pair of arrays 10 during a first time period; then (b) sends an AC current through the other pair of arrays 10 during a second time period; and then repeats steps (a) and (b) for the duration of treatment.

[0005] The field generator 14 includes an AC voltage generator 16 and a controller 18. The amplitude of the alternating current supplied via the transducer array 10 is controlled by the controller 18 so that the skin temperature (as measured on the skin beneath the transducer array) does not exceed a safe threshold of 41 degrees Celsius. Temperature measurements on the patient's skin are obtained using thermistors (not shown) placed beneath some disks (not shown) within the transducer array 10. In existing Optune® systems, each array 10 includes eight thermistors, one of which is positioned beneath a corresponding disk within the array.

[0006] Temperatures from all 32 thermistors (4 arrays × 8 thermistors per array) are measured and converted from analog to digital to a digital value for each thermistor. These measurements are then transmitted from transducer interface 20 to field generator 14. Controller 18 in field generator 14 uses the temperature measurements to control the current delivered through each pair of arrays 10 in order to maintain the temperature on the patient's skin below 41 degrees Celsius.

[0007] In the existing Optune® system, there are four long 10-conductor cables 12, each of which extends between a respective array 10 and a transducer interface 20; and an 8-conductor spiral cable (not specifically illustrated) which extends between the transducer interface 20 and a connector 28 on the field generator 14. Each of the 10-conductor cables 12 has 8 conductors for carrying signals from the 8 thermistors; 1 conductor for a common terminal for all 8 thermistors; plus 1 conductor for providing the TTFields signal (i.e. current) to the array 10. The 8-conductor spiral cable has 1 conductor for powering the transducer interface 20 (Vcc), supplied by a power source in the field generator; 1 conductor for grounding to the transducer interface 20; 2 conductors for serial data communication (sending temperature readings from the transducer interface 20 to the field generator 14); plus 4 conductors for the TTFields signal (i.e. one signal for each of the four arrays 10). The 8-conductor spiral cable has a second connector 26 at its end which mates with the first connector 28 on the field generator 14.

[0008] Furthermore, in order for a care provider to monitor the course of treatment of a patient, the field generator 14 includes one or more data storage registers (i.e. memory) 30 in which patient treatment data is stored. The information in the treatment data can include, for example, the time and date of a treatment session; the current applied by each transducer array 10; the temperature measured by the thermistors; any anomalies; etc. Currently, the treatment data that has been stored in the field generator is only accessible by having the patient bring the Optune® system to a facility where a technician accesses and downloads the data via a dedicated service port. SUMMARY

[0009] The disclosed apparatus facilitates the transfer of data from the Optune® system to a remote facility without the need for the patient to transport the Optune® system. Thus, the disclosed apparatus features a data transfer apparatus (“DTA”) which connects to the field generator (in which patient treatment data is stored) using the same single connector that is traditionally used to attach the transducer interface to the field generator. The field generator is configured to automatically determine whether a transducer interface or a DTA is connected to it. When a transducer interface is connected to the field generator, the field generator applies an AC voltage (via the transducer interface) to the transducer arrays to deliver TTFields therapy to a patient. On the other hand, when a DTA is connected to the field generator, the field generator transfers patient treatment data to the DTA, and the DTA accepts the data from the field generator. Subsequently, after the DTA has been disconnected from the field generator, the DTA transmits the data to a remote server, e.g. via the internet (wirelessly or via a wired connection) or via cellular data transmission.

[0010] Because data is transmitted to a remote server, this arrangement eliminates the need for patients to bring their Optune® system to the facility, a significant convenience for patients. Furthermore, because the DTA or transducer interface is attached to the field generator using the same single connector, there is no risk of incorrectly applying current from the DTA to the transducer (and therefore to the patient). In other words, electrical isolation is maintained between the patient and signals other than those generated by the field generator. Additionally, providing the DTA as a distinct device avoids the need for data transmission certification (e.g., by the Federal Communications Commission) in addition to medical device certification (e.g., by the Food and Drug Administration).

[0011] One aspect of the present invention relates to a data transmission device for use in association with a field generator of a TTFields (Tumor Treatment Fields) therapy system. The field generator has a first connector for outputting AC signals and transmitting serial data. The data transmission device includes a serial data transceiver; a memory; a modem; and a second connector configured to mate with the first connector. The data transmission device also includes a controller programmed to execute instructions to cause the data transmission device to perform the following steps: (1) determining that the field generator is connected to the data transmission device; (2) after determining that the field generator is connected to the data transmission device, causing the serial data transceiver to accept serial data from the field generator and store the accepted data in the memory, wherein the accepted data is data relating to the treatment of a patient using TTFields; (3) after receiving data from the field generator, determining whether the field generator has been disconnected from the data transmission device; and (4) after determining that the field generator has been disconnected from the data transmission device, retrieving data relating to the treatment of a patient using TTFields from the memory and causing the modem to transmit the retrieved data to a remote server.

[0012] In some embodiments of the data transmission device, the controller is programmed to cause the field generator to clear the data related to TTFields treatment that has been stored in the field generator once all data related to the treatment of the patient using TTFields has been received.

[0013] In some embodiments of the data transmission apparatus, the modem is configured to transmit data via the Internet. In some embodiments of the data transmission apparatus, the modem is configured to transmit data via a cellular data network.

[0014] Some embodiments of the data transmission device further include a switch actuated when another device is physically connected to the data transmission device. In these embodiments, the controller is programmed to determine that the field generator has been connected to the data transmission device by detecting the state of the switch. Alternatively, in these embodiments, the controller is further programmed to determine that the field generator has been disconnected from the data transmission device by detecting the state of the switch.

[0015] In some embodiments of the data transmission device, the connection between the field generator and the data transmission device interface is achieved by directly engaging the second connector with the first connector.

[0016] In some embodiments of the data transmission device, the connection between the field generator and the data transmission device interface is achieved by connecting a cable between the second connector and the first connector.

[0017] Another aspect of the present invention relates to a TTFields (tumor treatment field) therapeutic field generator. The field generator includes an AC voltage generator; a serial data transceiver; a memory; and a single first connector having: 1) a first plurality of pins for outputting an AC voltage generated by the AC voltage generator, and 2) a second plurality of pins for transmitting serial data to and from the serial data transceiver. The field generator also includes a controller programmed to execute instructions to cause the field generator to perform the following steps: (1) determining whether a transducer interface has been connected to a first connector; (2) after determining that the transducer interface has been connected to the first connector, activating an AC voltage generator such that an AC voltage appears across a first plurality of pins of the first connector and storing data related to TTFields treatment in a memory; (3) determining whether a data transmission device has been connected to the first connector; and (4) after determining that the data transmission device has been connected to the first connector, retrieving data related to TTFields treatment from the memory and routing the retrieved data to a serial data transceiver such that the serial data transceiver outputs data related to TTFields treatment via a second plurality of pins of a single first connector.

[0018] In some embodiments of the field generator, the controller is programmed to determine that the transducer interface has been connected to the first connector by examining data received via a serial data transceiver.

[0019] In some embodiments of the field generator, the controller is programmed to determine that the data transmission device has been connected to the first connector by examining the data received via a serial data transceiver.

[0020] In some embodiments of the field generator, the controller is programmed to clear the data related to TTFields treatment from memory after the serial data transceiver has output data related to TTFields treatment.

[0021] In some embodiments of the field generator, the data related to TTFields therapy stored in the memory includes the time and date of the treatment session, the current applied by each of the transducer arrays in the set that are connected to the first connector, the measured temperature value, and one or more operational anomalies.

[0022] Another aspect of the present invention relates to a TTFields (Tumor Therapy Fields) therapy system with enhanced diagnostics. The system includes a field generator and a data transmission device. The field generator includes an AC voltage generator; a first serial data transceiver; a first memory; a single first connector having: 1) a first plurality of pins for outputting an AC voltage generated by the AC voltage generator, and 2) a second plurality of pins for transmitting serial data to and from the first serial data transceiver; and a first controller. The first controller is programmed to execute instructions to cause the field generator to perform the following steps: (1) determine whether the transducer interface is connected to the first connector; (2) after determining that the transducer interface is connected to the first connector, activate the AC voltage generator such that an AC voltage appears across a first plurality of pins of the first connector, and store data related to TTFields treatment in the first memory; (3) determine whether the data transmission device is connected to the first connector; and (4) after determining that the data transmission device is connected to the first connector, retrieve data related to TTFields treatment from the first memory, and route the retrieved data to a first serial data transceiver such that the first serial data transceiver outputs data related to TTFields treatment via a second plurality of pins of a single first connector. The data transmission device includes a second serial data transceiver, a second memory, a modem, a second connector configured to mate with the first connector, and a second controller. The second controller is programmed to execute instructions to cause the data transmission device to perform the following steps: (1) determine that the field generator is connected to the data transmission device; (2) after determining that the field generator is connected to the data transmission device, cause the second serial data transceiver to accept serial data from the field generator and store the accepted data in a second memory, wherein the accepted data is data related to the treatment of a patient using TTFields; (3) after receiving data from the field generator, determine whether the field generator has been disconnected from the data transmission device; and (4) after determining that the field generator has been disconnected from the data transmission device, retrieve the data related to the treatment of a patient using TTFields from the second memory and cause the modem to transmit the retrieved data to a remote server.

[0023] In some embodiments of the system, the first controller is programmed to (a) determine that the transducer interface has been connected to the first connector by examining data received via the first serial data transceiver, and (b) determine that the data transmission device has been connected to the first connector by examining data received via the first serial data transceiver.

[0024] In some embodiments of the system, the first controller is programmed to clear the data related to TTFields treatment from the first memory after the first serial data transceiver has output data related to TTFields treatment.

[0025] In some embodiments of the system, data related to TTFields therapy stored in the first memory includes the time and date of the treatment session, the current applied by each of the transducer arrays in the set of transducer arrays that have been connected to the first connector, the measured temperature value, and one or more operational anomalies.

[0026] In some embodiments of the system, the connection between the field generator and the data transmission device interface is achieved by directly engaging the second connector with the first connector. In some embodiments of the system, the connection between the field generator and the data transmission device interface is achieved by connecting a cable between the second connector and the first connector. Attached Figure Description

[0027] Figure 1 is a schematic diagram illustrating a system for TTFields treatment therapy according to the prior art;

[0028] Figure 2A This is a schematic diagram illustrating an array of transducers connected to a field generator, and Figure 2B This is a schematic diagram of the DTA connected to the field generator;

[0029] Figure 3 This is a flowchart illustrating the steps a patient takes when using a system for uploading data related to TTField treatment.

[0030] Figure 4A and 4B These are high-level flowcharts illustrating the overall operation of the DTA and the field generator, respectively; and

[0031] Figures 5A-5E The diagram is presented. Figure 2A and 2B The flowchart illustrates the exemplary operational logic of the DTA and field generator. Detailed Implementation

[0032] Figure 2A , 2B Figures 3, 4A, 4B, and 5A-5E illustrate components for use in conjunction with the TTFields therapeutic therapy according to the present invention. Generally, the components include a field generator 40, four transducer arrays 10 and a transducer interface 20, and a data transmission device (DTA) 42.

[0033] like Figure 2A and 2BAs illustrated, the field generator 40 includes a controller 44; an AC voltage generator 46 similar to the AC voltage generator 16 in Figure 1; a serial data transceiver 48, for example, an RS485 communication circuit similar to the RS-485 communication circuit 17 in Figure 1; a memory 50; and a field generator connector 52. The controller 44 is programmed to perform most of the functions of the controller 18 of Figure 1, but the controller 44 also performs several additional functions. In particular, the controller 44 is programmed to determine whether the transducer interface 20 or the DTA 42 is connected to the field generator connector 52. Figure 2A As illustrated, if transducer interface 20 is connected to field generator connector 52, then controller 44 operates similarly to controller 18, delivering TTFields therapy to the patient by activating AC voltage generator 46. On the other hand, as... Figure 2B As illustrated, if DTA 42 is connected to field generator connector 52, then controller 44 controls the transmission of data related to TTFields therapy from field generator 40 to DTA 42, so that DTA can then transmit the data related to TTFields therapy to a remote server, for example, in a data center.

[0034] like Figure 2A As illustrated, the field generator connector 52 (also referred to herein as the “first connector”) is configured to mate with the transducer interface 20 via a second connector 26, allowing the AC current generated by the field generator 40 to be applied to the patient for TTFields therapy. Four wires 54 extend from the voltage generator 46 and carry the current (TTFields signal) to be supplied to each of the four transducer arrays 10, and two wires 56 extend from the serial data transceiver 48 for serial data communication of temperature readings from the transducer interface 20. These wires 54 and 56 terminate in corresponding electrical connection pins (not shown) in the field generator connector 52. (As used herein, the term “pin” can refer to a male or female connection terminal.)

[0035] like Figure 2BAs illustrated, the DTA 42 includes an AC power supply 58, a serial data transceiver 64 (e.g., RS485 communication circuitry), and a memory (e.g., EEPROM 66) that can store data related to patient treatment using the TTFields therapy, received from the field generator 40 (as further described below), as well as system settings. The DTA 42 may also include a flash memory reader / writer 68, which can be used to back up LOG data to, for example, an SD card. The DTA 42 also includes at least one communication modem, such as an internet modem 70 and / or a cellular data modem 72. Additionally, the DTA 42 includes a controller 74 programmed to control the operation of the DTA 42, as further described below.

[0036] DTA 42 has a DTA connector 76 (also referred to herein as the second connector) configured to mate with field generator connector 52. Two wires 78 extend from serial data transceiver 64 and provide a serial data communication path for DTA 42 to receive data related to patient treatment using the TTFields therapy from field generator 40. These wires 78 terminate in electrical connection pins (not shown) in DTA connector 76, which engage with corresponding pins in field generator connector 52.

[0037] Figure 3 The diagram illustrates the use of Figure 2A An example of hardware uploading data related to TTFields therapy described in / 2B. The data transfer session begins when field generator 40 is turned on (S80) and DTA 42 is turned on (S82). Field generator 40 and DTA 42 each perform a power-on self-test (S84, S86), and when the self-test is complete, an indicator (e.g., an LED) on each unit will light up. At this time, field generator 40 can be connected to DTA 42 by connecting field generator connector 52 to DTA connector 76 (S88). Then, the data related to TTFields therapy stored in field generator 40 will be 1) transferred to DTA 42 and 2) cleared from field generator 40, after which another indicator (e.g., an LED) on each device will be illuminated (S90). Field generator 40 can then be disconnected from DTA 42 (S92).

[0038] Once the field generator 40 has been disconnected from the DTA 42, the field generator 40 can be restarted and the transducer array connected to the field generator 40 can be done by connecting the second connector 26 of the transducer interface 20 to the field generator connector 52 (S94), as follows. Figure 2A As illustrated in the diagram. Then the TTFields therapy (S96) can begin.

[0039] Additionally, once the field generator 40 has been disconnected from the DTA 42—and only after the field generator 40 has been disconnected from the DTA 42—the DTA 42 will begin transmitting the TTFields therapy-related data it has received from the field generator 40 to the remote server. By not transmitting TTFields-related data until after the field generator 40 has been disconnected from the DTA 42, the isolation of the field generator 40—and therefore the overall TTFields therapy system—can be maintained. Thus, this arrangement protects the patient. Additionally, it avoids the need to certify the TTFields therapy system as a data communication device in addition to certifying it as a medical device.

[0040] Once DTA 42 has transmitted all received data related to TTFields treatment to the remote server, the indicator (e.g., LED) is turned on (S98), and DTA 42 can be turned off (S100).

[0041] exist Figure 4A , 4B Examples of suitable operating logic for field generator 40 and DTA 42 are illustrated in 5A-5E.

[0042] (Note that in the case of field generator 40 or DTA 42 performing specific steps in this description, it should be understood that the corresponding controller 44 or 74 is programmed to perform specific steps.)

[0043] Generally speaking, (such as) Figure 2B The operation logic of DTA 42 (shown in the diagram) is in Figure 4A The process begins with DTA 42 determining whether a device is connected to it via DTA connector 76 (S101). If no device is connected to DTA 42 (result path 103), the process returns to the top, and DTA 42 continues to monitor devices connected to it.

[0044] On the other hand, if the device is connected to DTA 42, the process proceeds to step S105, where DTA 42 determines whether the connected device is field generator 40. If the connected device is not field generator 40 (result path 107), an error message is sent (S270), and the process terminates. Otherwise, DTA 42 requests (S109) data related to the TTFields therapy from field generator 40, then accepts the data and stores it in its onboard memory 66 (S111). Whenever DTA 42 receives data from field generator 40, DTA 42 inquires whether there is more data to be transmitted (S113). As long as the data is still in field generator 40 to be transmitted to DTA 42 (result path 115), DTA 42 will continue to accept and store data from field generator 40.

[0045] Once all data has been transmitted from field generator 40 to DTA 42 (result path 117), DTA 42 determines whether field generator 40 has been disconnected from DTA 42 (S119). If field generator 40 has not yet been disconnected from DTA 42 (result path 121), the user is prompted to disconnect the field generator (S123). On the other hand, once field generator 40 has been disconnected from DTA 42 (result path 125), DTA 42 uploads the data it has received from field generator 40 to the remote server (S127).

[0046] Generally speaking, ( Figure 2A and 2B The operation logic of the field generator 40 shown is in Figure 4B As shown in the diagram. The process begins with the field generator 40 determining whether a device is connected to it via the field generator connector 52 (S131). Once connected, the field generator begins sending a communication request once per second via the field generator connector 52. Therefore, if no device is connected to the field generator 40 (result path 133), there will be no response to the communication request from the field generator, and the field generator 40 will continue to wait until a device is actually connected to it. On the other hand, if a device is connected to the field generator 40 (result path 135), the field generator 40 determines in step S137 that the connected device is a collection of transducer arrays 10 (connected to the field generator 40 via transducer interface 20, such as...). Figure 2A The one described) or DTA 42 (as Figure 2B (As depicted in the text). This can be done, for example, by examining device identification data received from whichever device is connected to the field generator.

[0047] If the connected device is a collection of transducer arrays 10 (result path 139), the field generator 40 provides AC voltage to the transducer arrays 10 to provide TTFields therapy to the patient (S141), while storing data related to the TTFields therapy in its memory 50. On the other hand, if the connected device is a DTA 42 (result path 143), the field generator 40 retrieves the stored data related to the TTFields therapy from its memory 50 and transmits the retrieved data to the DTA 42 (S145) for subsequent uploading to a remote server by the DTA 42.

[0048] Figures 5A-5E This describes in more detail an example of how data can flow between the field generator 40 and the DTA 42 when the field generator 40 is connected to the DTA 42, and how data can flow between the DTA 42 and the remote server when the field generator 40 is not connected to the DTA 42. However, note that a variety of alternative methods can be used. Operation begins once each of the field generator 40 and the DTA 42 has completed its power-on self-test (S84, S86, respectively). Once the power-on self-test in the field generator 40 is complete, the field generator 40 begins to "listen" for incoming communication requests (S108).

[0049] Simultaneously, once the power-on self-test in DTA 42 is complete, DTA checks (S110) to determine if there is sufficient available memory in DTA 42 (e.g., in EEPROM 66 and / or in the SD card inserted into flash memory reader / writer 68) to receive and store the complete set of data related to the TTFields therapy from field generator 40. If there is insufficient memory available in DTA 42 (i.e., result path 112), then the routine proceeds to the remote communication portion of the process, where an internet connection is established (S196). Figure 5D Instead of establishing a data communication connection between DTA 42 and field generator 40. On the other hand, if there is actually enough memory in DTA 42 to receive and store the complete set of data related to the TTFields therapy from field generator 40 (i.e., result path 114), then the serial data transceiver 64 in DTA 42 will be turned on (S116).

[0050] At this point in the process, DTA 42 will begin to evaluate whether another device is connected to DTA 42, and if so, whether the other device is identified as field generator 40 (S118). A suitable method for performing this evaluation is to use (a) a switch actuated when another device is physically connected to DTA 42, and (b) a sensor configured to detect power-on of the field generator. Once the switch and sensor indicate that field generator 40 has been connected to DTA 42, DTA 42 will begin listening for connection requests from field generator 40.

[0051] If the connected device is not identified as field generator 40 (result path 120), DTA 42 will continue to attempt to identify the connected device until a predetermined timeout period is reached. If the timeout period is reached (i.e., result path 122), an error message is displayed (S124), and the process terminates. On the other hand, if the connected device is determined to be field generator 40 (result path 126), then DTA 42 attempts to establish a data transmission connection between itself and field generator 40—that is, between serial data transceiver 64 in DTA 42 and serial data transceiver 48 in field generator 40—by sending a connection request to field generator 40 (S128).

[0052] When the field generator 40 receives a connection request from another device (S130), the field generator 40 will determine, for example, from the received data (S132) which device is connected. If the connected device is a collection of transducer arrays (result path 134), connected to the field generator 40 via the transducer interface 20, then the field generator 40 will wait for the initiation of TTFields therapy (S136). Once the patient initiates TTFields therapy (not in... Figure 5A (As indicated above), for example, by pressing the start button on the field generator 40, the field generator 40 outputs AC voltage to the transducer array 10 to provide TTFields therapy, as described above. Figure 2A As described. On the other hand, if DTA 42 (result path 138) is connected, the field generator 40 will respond to the connection request by attempting to connect to DTA 42 to complete the data transmission connection (S140).

[0053] Field generator 40 will continue to attempt to connect to DTA 42 until a predetermined timeout period begins when DTA 42 sends a connection request (S128). If the timeout period is reached (i.e., result path 142), an error message is displayed (S124), and the process terminates.

[0054] On the other hand, if the field generator 40 successfully completes the data transfer connection before the timeout period expires (result path 146), the DTA 42 will initiate the transfer of data related to the TTFields therapy from the field generator 40 (i.e., from memory 50) to its own memory (i.e., to EEPROM 66) (S148). To this end, the DTA 42 sends an inquiry to the field generator 40 to determine whether any data related to the TTFields therapy that has not yet been transferred to the DTA 42 is still in memory 50 (S150). If there is untransferred data related to the TTFields therapy in memory 50 (result path 152), the DTA 42 sends a request to the field generator 40 for the field generator 40 to send the data related to the TTFields therapy to the DTA 42 (S154), and the field generator 40 responds by transferring the data related to the TTFields therapy to the DTA 42 (S156).

[0055] DTA 42 processes the incoming data related to the TTFields therapy (S158), copies it to EEPROM 66 (S160), and then verifies the data (S162). If the data is invalid (result path 164), an error is indicated (S166), and the process terminates. Otherwise, if the data is valid (result path 168), the process returns to recheck whether any untransmitted data related to the TTFields therapy is still in memory 50 (S150).

[0056] Once there is no longer any untransmitted data related to the TTFields therapy remaining in memory 50 (outcome path 170), Figures 5C to 5D DTA will then store the data in EEPROM 66 (S172). Additionally, if a flash memory reader / writer 68 is present, the verified data related to the TTFields therapy will be stored in a removable medium present in the reader / writer 68 (S174).

[0057] Next, DTA 42 initiates a data clearing process (S176) and sends a command (S178) to field generator 40, instructing field generator 40 to clear the data related to TTFields therapy from its memory 50. In response to the command, field generator 40 clears the data related to TTFields therapy from its memory 50 (S180), and upon completion of the clearing step, sends a confirmation message back to DTA 42 (S182) indicating that it (field generator 40) has done so.

[0058] Once an acknowledgment message is received, DTA 42 shuts down its serial data transceiver 64 (S184) to close communication with the field generator 40. DTA 42 then checks (S186) to determine, for example, using a switch actuated when another device is physically connected to DTA, whether the field generator 40 has been disconnected from DTA. As long as the field generator 40 remains connected to DTA 42 (resulting path 188) and until the timeout period—initiated when DTA 42 receives a data clear acknowledgment message and shuts down its serial data transceiver 64—expires, DTA 42 will continue to check whether the field generator 40 has been disconnected from DTA 42.

[0059] If the timeout period expires (Result Path 190), the DTA indicates an error (S192), for example by lighting an LED or displaying a message instructing the patient to disconnect the field generator 40 from the DTA 42, and all processing terminates without transmitting any previously received data. Alternatively, once the field generator 40 has disconnected from the DTA 42 (Result Path 194), the DTA 42 will begin transmitting the data it has received from the field generator 40 related to the TTFields therapy to a remote data center server. It should be noted that while the DTA is still connected to the field generator 40, the DTA 42 will never initiate a communication session with the server.

[0060] After the DTA 42 has disconnected from the field generator 40, the DTA 42 will establish a communication connection with either the onboard Internet modem 70 or the cellular data modem 72 (S196), depending on which type of modem the DTA 42 has. (If the DTA 42 has both an Internet modem and a cellular data modem, the DTA 42 can be configured to allow the patient to choose which data communication mode to use.) The data upload process then begins by sending a connection request to the server at the data center (S200) (S198).

[0061] Upon receiving a connection request, the server will attempt to authenticate it (S202). If the connection request is not authenticated (result path 204), the connection will be rejected (S206), and an error message will be displayed on DTA 42. On the other hand, if the connection request is authenticated (result path 208), the remote server will send a message accepting the connection request to DTA 42 (S210).

[0062] Once DTA 42 receives a message indicating that the connection request has been accepted, it checks (S212) whether there is any data related to the TTFields therapy in its memory 66 that has not yet been uploaded to the data center. If there is no remaining data to be uploaded (result path 214), the communication connection is closed (S216), and the data related to the TTFields therapy stored in DTA's memory 66 is cleared (S218). Then, the process returns to (path 220, Figure 5E Back Figure 5B The serial data transceiver 64 of the DTA is reconnected (S116), at which point the DTA 42 begins checking the devices connected to it again. On the other hand, if there is actually remaining data to be uploaded in the DTA's memory 66 (result path 224), the DTA 42 will transmit the data packet to the remote server (S226).

[0063] Once a data packet is received, the remote server verifies the incoming packet (S228). If the incoming packet is invalid (result path 230), the remote server sends an error message to DTA 42 (S232), and DTA displays a communication error indicator (S234). On the other hand, if the incoming packet is actually valid (result path 236), the remote server examines the packet (S238) to see if it is the last packet in the transmission of a given data unit. If the received packet is not the last packet (result path 240), the remote server sends an acknowledgment message to DTA 42 confirming receipt of the data packet (S242), and DTA 42 checks again (S212) to see if any untransmitted data is still in its memory 66. As long as the untransmitted data still exists (result path 224), DTA 42 will continue to send data packets to the remote server.

[0064] When the received packet is the last packet in the transmission of a given data unit (result path 246), the remote server finalizes the data by assembling the packet (S248) and then attempts to verify the assembled data (S250). If the assembled data is invalid (result path 252), the remote server sends an error message to DTA 42 (S232), and DTA 42 displays a communication error indicator (S234). On the other hand, if the assembled data is actually valid (result path 258), it is added to the database on the remote server (S260). The remote server then sends a message to DTA 42 acknowledging receipt of the data packet (S242), and DTA 42 checks again to see (S212) whether any untransmitted data is still in its memory 66.

[0065] This process will repeat until no untransmitted remaining data remains in the memory 66 of DTA 42 (result path 214). When this point is reached, the data transmission connection with the remote server is closed (S216), and data related to the TTFields therapy is cleared from the memory 66 of DTA 42 (S218). Then, the process returns to (path 220, ...). Figure 5E Back Figure 5B The serial data transceiver 64 of the DTA is turned on, and the DTA 42 checks the devices connected to it.

[0066] While the invention has been disclosed with reference to certain embodiments, many modifications, alterations, and variations of the described embodiments are possible without departing from the scope and range of the invention as defined in the appended claims. Therefore, it is intended that the invention be limited to the described embodiments, but rather has the full scope defined by the language of the following claims and their equivalents.

Claims

1. A TTFields (Tumor Treatment Field) therapy field generator, comprising: AC voltage generator; Serial data transceiver; Memory; A single first connector having 1) a first plurality of pins for outputting an AC voltage generated by an AC voltage generator, and 2) a second plurality of pins for transmitting serial data to and from a serial data transceiver; as well as The controller is programmed to execute instructions that cause the field generator to perform the following steps: (1) Determine whether the transducer interface has been connected to the first connector. (2) After determining that the transducer interface has been connected to the first connector, activate the AC voltage generator so that the AC voltage appears across the first plurality of pins of the first connector and store the data related to TTFields treatment in the memory. (3) Determine whether the data transmission device has been connected to the first connector; and (4) After determining that the data transmission device has been connected to the first connector, retrieve data related to TTFields treatment from the memory and route the retrieved data to the serial data transceiver, such that the serial data transceiver outputs data related to TTFields treatment via a second plurality of pins of a single first connector.

2. The field generator of claim 1, wherein the controller is programmed to determine that the transducer interface has been connected to the first connector by examining data received via a serial data transceiver.

3. The field generator of claim 1, wherein the controller is programmed to determine that the data transmission device has been connected to the first connector by examining data received via a serial data transceiver.

4. The field generator of claim 1, wherein the controller is programmed to clear the data related to TTFields treatment from memory after the serial data transceiver has output data related to TTFields treatment.

5. The field generator of claim 1, wherein the data related to the TTFields therapy stored in the memory includes one or more of the following: the time and date of the treatment session, the current applied by each of the transducer arrays in the set of transducer arrays already connected to the first connector, temperature measurements on the patient's skin, and operational anomalies.

6. A TTFields (Tumor Therapy Fields) therapy system with enhanced diagnostics, the system comprising: Field generator; and Data transmission device, The field generator includes AC voltage generator First serial data transceiver, First memory, A single first connector having 1) a first plurality of pins for outputting an AC voltage generated by an AC voltage generator, and 2) a second plurality of pins for transmitting serial data to and from a first serial data transceiver; as well as The first controller is programmed to execute instructions that cause the field generator to perform the following steps: (1) Determine whether the transducer interface has been connected to the first connector; (2) After determining that the transducer interface has been connected to the first connector, activate the AC voltage generator so that the AC voltage appears across the first plurality of pins of the first connector and store the data related to TTFields treatment in the first memory. (3) Determine whether the data transmission device has been connected to the first connector; and (4) After determining that the data transmission device has been connected to the first connector, data related to TTFields treatment is retrieved from the first memory, and the retrieved data is routed to the first serial data transceiver, such that the first serial data transceiver outputs the data related to TTFields treatment via a second plurality of pins of a single first connector, and The data transmission device mentioned above includes Second serial data transceiver, Second memory, modem, A second connector configured to mate with the first connector, and The second controller is programmed to execute instructions that cause the data transmission device to perform the following steps: (1) Confirm that the field generator is connected to the data transmission device. (2) After determining that the field generator has been connected to the data transmission device, the second serial data transceiver is made to accept serial data from the field generator and store the accepted data in the second memory, wherein the accepted data is data related to the treatment of patients using TTFields. (3) After receiving data from the field generator, determine whether the field generator has been disconnected from the data transmission device, and (4) After determining that the field generator has been disconnected from the data transmission device, retrieve data related to the treatment of patients using TTFields from the second memory and cause the modem to transmit the retrieved data to the remote server.

7. The system of claim 6, wherein the first controller is programmed to (a) determine that the transducer interface has been connected to the first connector by examining data received via the first serial data transceiver, and (b) determine that the data transmission device has been connected to the first connector by examining data received via the first serial data transceiver.

8. The system of claim 6, wherein the first controller is programmed to clear the data related to TTFields treatment from the first memory after the first serial data transceiver has output data related to TTFields treatment.

9. The system of claim 6, wherein the data related to the TTFields therapy stored in the first memory includes one or more of the following: the time and date of the treatment session, the current applied by each of the transducer arrays in the set of transducer arrays already connected to the first connector, temperature measurements on the patient's skin, and operational abnormalities.

10. The system of claim 6, wherein the connection between the field generator and the data transmission device interface is achieved by directly engaging the second connector with the first connector.

11. The system of claim 6, wherein the connection between the field generator and the data transmission device interface is achieved by connecting a cable between the second connector and the first connector.

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