Patent Abstract:
A multiprogrammer system, for monitoring and optimizing implant performance, includes at least two programmers and an implant. Each programmer may perform inquiry and programming operations on the implant. In an inquiry operation, the programmer retrieves some or all of the configuration parameters from the implant. In a programming operation, the programmer provides one or more modified parameters to the implant. As part of the programming operation, the programmer is configured to verify that it is aware of the implant&#39;s current parameters before sending modified parameters. The current programmer verifies that the implant&#39;s parameters have not been altered since the current programmer&#39;s last interaction with the implant. If the parameters have been altered, the current programmer aborts the programming operation and provides notification. The verification may be performed by the implant, i.e., it may verify that the programmer is aware of the current device parameters before the implant accepts modified parameters.

Full Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     This invention relates generally to programming of implantable devices, and more particularly to a programming system which addresses the dangers raised by the presence of multiple programming devices.  
         [0003]     2. Description of the Related Art  
         [0004]     Implantable devices have become a standard method of treating various medical conditions, many of which relate to the heart. Examples of implantable devices include pacemakers, defibrillators, nerve stimulators, drug delivery devices, and implanted personal identification chips. Many types of implantable devices are available with high capacity memories for storing data and various programmable configuration parameters. In the case of medical devices, the data to be stored may include physiological data such as the electrogram (electrical waveform of the heart detected at the electrodes), instantaneous heart rate, blood pressure, volume pumped, body temperature, etc. Configuration parameters that are stored may include modes of operation, amplifier sensitivity, filter bandwidth, adaptation algorithms, output voltages, currents and pulse widths, blanking periods, various pacing rates, circadian response patterns, lead characteristics, delay intervals, detection thresholds, safety margins, logging criteria, and error messages. As implantable devices increase in sophistication, the number of configuration parameters is also expected to increase.  
         [0005]     Referring now to  FIG. 1 , a human torso  102  is shown having an implantable device  106  coupled to a heart  104 . When a wand  108  from an external programming device  110  is placed in proximity to implantable device  106 , the programming device  110  can establish two-way communication with implantable device  106  to retrieve data and to provide new configuration parameters. Often the device  106  collects data over a period of hours or days. In the case of a pacemaker, the data may represent measured physiological signals such as cardiac voltages (EKG signals), blood temperatures, oxygen levels, sugar levels, and other physical parameters.  
         [0006]     Illustratively, the programming device  110  comprises an implantable device programmer and data analyzer that is used by a physician. The programmer/analyzer operates to download information stored in implantable device  106  by transmitting signals which place the pacer in a mode for downloading, and thereafter detecting signals sent by the device. Then, under control of the physician or other medical professional, the programmer/analyzer operates to analyze and display the information in a format which allows the physician to diagnose any problems. After performing an analysis, the physician may instruct the programmer/analyzer to adjust operating parameters for a different mode of operation, sensitivity setting, or other parameter value, to tailor the behavior of the device to the patient and thereby optimize the patient&#39;s quality of life. If this is the case, the programmer/analyzer  110  provides new operating parameters to the implantable device  106 .  
         [0007]     Implant manufacturers have long been aware of a danger known as the “multiple programmer” problem which can result in an implantable device having incorrect and perhaps even dangerous or harmful configuration parameters. The following scenario is presented to illustrate this problem.  
         [0008]     A patient with an implantable device enters an examination room, and as part of a routine initial examination has a medical technician use a first programming device “A” to download data and configuration parameters from the implantable device. Depending on the amount of data and the baud rate of the device, the download time may range from 20 seconds to 20 minutes. In the absence of any gross abnormalities in the downloaded data, the patient is sent to another room for an exercise session to determine “rate modulated” settings, i.e. configuration parameters for adjusting the pacemaker pace rate in response to detecting patient exertion. In this room, a physician uses a second programming device “B” to download and adjust the configuration parameters in response to the results of the exercise session. Programming device “B” is used to reprogram the implantable device with the adjusted parameters. The patient then returns to the examination room, where a physician uses programming device “A” to adjust some of the configuration parameters in response to analysis of the downloaded data. Programming device “A” is then used to reprogram the implantable device with the adjusted parameters. It is important to note&#39;that programming device “A” is, at this point, operating with an obsolete version of the implant&#39;s configuration settings. This situation occurs whenever changes are made to the implantable device&#39;s configuration parameters by a second programming device “B” between the download and reprogramming operations of the first programming device “A”.  
         [0009]     The configuration parameters of an implantable device such as a pacemaker can individually be set to typical values within a normal operating range, but the programming device must still check for incompatible parameter settings to avoid dangerous combinations of parameter values. For example, programming an inappropriately long refractory period in conjunction with a short pacing cycle may lead to unpredictable pacing behavior. If a programming device with an obsolete version of the implant device&#39;s configuration settings reprograms only a few parameters, any safeguards that the programming device implements to avoid incompatible parameter settings could be unintentionally circumvented.  
         [0010]     One programmer safeguard that has been employed is to have programming device “A” reprogram the implantable device with a complete set of configuration parameters rather than just the parameters which have been adjusted. Although this successfully prevents incompatible configuration settings, the previous adjustments are completely undone without any indication to the physician. Further, the reprogramming time is unnecessarily increased beyond what may be strictly necessary.  
         [0011]     The solution commonly employed by implant manufacturers has been simply to issue warnings regarding the danger of using multiple programming devices. A more effective and inexpensive solution to the multiple programming device problem is desirable.  
       SUMMARY OF THE INVENTION  
       [0012]     Accordingly, there is provided herein a multiprogrammer system for monitoring and optimizing implantable device performance. In one embodiment, the system includes at least two programming devices and an implantable device. Each of the programming devices may be used to perform inquiry and programming operations on the implantable device. In an inquiry operation, the programming device retrieves some or all of the configuration parameters from the implantable device. In a programming operation, the programming device provides one or more modified parameters to the implantable device. As part of the programming operation, the programming device is configured to verify that it is aware of the implantable device&#39;s current parameters before sending the modified parameters. In other words, the current programming device verifies that the implantable device&#39;s parameters have not been altered by another programming device since the current programming device&#39;s last interaction with the implantable device. If the parameters have been altered, the current programming device aborts the programming operation and notifies the operator. In alternate embodiments, the verification may be performed by the implantable device, i.e. the implantable device may verify that the programming device is aware of the current device parameters before the implantable device accepts the modified parameters.  
         [0013]     As part of the multiprogrammer system provided herein, there is disclosed a programming device embodiment, an implantable device embodiment, and various methods for verifying that the programming device has been provided with a current version of the implantable device&#39;s configuration parameters. The programming device preferably comprises a user interface, a memory, a communications circuit, and a microprocessor. The communications circuit generally includes a communication coil, receive sensor, modulator, and demodulator, and is configurable to send and receive configuration parameters to and from the implantable device. The microprocessor couples to the user interface, the memory, and the communications circuit, and it operates under control of the user interface to retrieve configuration parameters from the implantable device and to store the parameters in memory. The configuration parameters may be modified, and the modified parameters can be sent to the implantable device. In certain disclosed embodiments, the microprocessor uses one of the following methods to verify that the stored configuration parameters are “current” before sending the modified parameters, that is, the microprocessor verifies that the implantable device&#39;s parameters have not been altered .since this programmable device last retrieved the implantable device&#39;s parameters.  
         [0014]     The implantable device comprises a microprocessor coupled to a memory and a telemetry module. The memory stores configuration parameters, and the telemetry module transmits and receives external communications. The microprocessor performs some algorithm in a manner governed by the configuration parameters stored in the memory. In certain disclosed embodiments, the microprocessor uses one of the following methods to verify that an external programming device has received a current version of the configuration parameters before accepting modified configuration parameters from the programming device.  
         [0015]     The disclosed methods for verifying that a programming device is aware of the implantable device&#39;s current configuration parameters include: (1) providing a programming device serial number to the implantable device as part of every inquiry operation; (2) allowing a programming operation only within a predetermined time interval after an inquiry operation; (3) storing the date and time of the most recent inquiry operation; (4) storing the date and time of the most recent programming operation; and (5) retrieving the implantable device&#39;s current parameters as part of every programming operation. For method (1), the implantable device or the programming device can be configured to compare the programming device&#39;s serial number with the serial number of the last programming device to retrieve the implantable device&#39;s configuration parameters. A match indicates that the programming device is aware of the implantable device&#39;s current parameter values.  
         [0016]     For method (2), the implantable device or the programming device can determine if the downloaded version of the configuration parameters has “expired”, that is, whether a predetermined amount of time has passed since the configuration parameters were last retrieved. For method (3), the implantable device or programming device can be configured to compare the date and time of the most recent inquiry stored in the programming device to that stored in the implantable device. A match indicates that the programming device is aware of the implantable device&#39;s current parameter values.  
         [0017]     Similarly, for method (4), the implantable device or programming device can be configured to compare the date and time of the most recent programming operation stored in the programming device to that stored in the implantable device. Finally, for method (5), the programming device can be configured to retrieve the implantable device&#39;s configuration parameters immediately prior to a programing operation to verify that the programming device has a current version. These methods will be described in more detail further below.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]     Other objects and advantages of the invention will become apparent upon reading the following detailed description and upon reference to the accompanying drawings in which:  
         [0019]      FIG. 1  shows an implantable medical device and a programming device;  
         [0020]      FIG. 2  is a block diagram of an implantable pacemaker;  
         [0021]      FIG. 3  is a block diagram of an exemplary embodiment of a programming device;  
         [0022]      FIG. 4  is a flowchart depicting a method for performing inquiry and programming operations;  
         [0023]      FIG. 5  is a flowchart illustrating the multiprogrammer problem;  
         [0024]      FIG. 6  is a flowchart depicting a first method for performing inquiry and programming operations in a multiprogrammer environment;  
         [0025]      FIG. 7  is a flowchart depicting a second method for performing inquiry and programming operations in a multiprogrammer environment;  
         [0026]      FIG. 8  is a flowchart depicting a third method for performing inquiry and programming operations in a multiprogrammer environment;  
         [0027]      FIG. 9  is a flowchart depicting a fourth method for performing inquiry and programming operations in a multiprogrammer environment;  
         [0028]      FIG. 10  is a flowchart depicting a fifth method for performing inquiry and programming operations in a multiprogrammer environment;  
         [0029]      FIG. 11  is a flowchart depicting a sixth method for performing inquiry and programming operations in a multiprogrammer environment;  
         [0030]      FIG. 12  is a flowchart depicting a seventh method for performing inquiry and programming operations in a multiprogrammer environment;  
         [0031]      FIG. 13  is a flowchart depicting an eighth method for performing inquiry and programming operations in a multiprogrammer environment; and  
         [0032]      FIG. 14  is a flowchart depicting a ninth method for performing inquiry and programming operations in a multiprogrammer environment. 
     
    
       [0033]     While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of examples in the drawings and will herein be described in detail. It should be understood, however, that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the present invention as defined by the appended claims.  
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0034]     The following description illustrates the principles of the present invention with respect to an implantable pacemaker (“pacer”) and a programming device (“programmer”). The invention, however, is directed to a system for permitting multiple programming devices to interact with an implantable device. Thus, the invention applies to implantable cardioverter/defibrillators (ICD&#39;s), nerve stimulators, drug delivery devices, or any other implantable device which may have programmable configuration parameters set by a programming device.  
         [0035]     Referring now to  FIG. 2 , an exemplary implantable device  106  (such as a pacemaker) preferably includes a power supply  202  coupled to a microprocessor  204 . The power supply  202  provides power to all the devices shown in  FIG. 2  through connections which are not specifically shown. In the exemplary embodiment, the microprocessor  204  couples to a memory  206 , a first interval timer  208 , and a second interval timer  210  via an I/O (input/output) bus  211 . The microprocessor  204  also couples to control an atrium sensor/stimulator  212  and a ventricle sensor/stimulator  214 , each of which may be coupled to the heart by flexible leads. Finally, microprocessor  204  couples to a telemetry module  218  to communicate with programming device  110 .  
         [0036]     The microprocessor  204  preferably is programmable and operates according to a program stored preferably in a nonvolatile memory such as a read-only memory (not specifically shown). The program is parameterized—i.e. one or more of the operations the microprocessor performs is alterable by setting a configuration parameter. For example, the microprocessor may be programmed to periodically trigger the atrium sensor/stimulator  212  to deliver a pulse to the heart  104 . In this instance, one of the configuration parameters for this operation is the maximum trigger delay, that is, a value specifying the maximum time delay before the atrium stimulator is triggered. The maximum trigger delay, along with other configuration parameters, is provided to microprocessor  204  via telemetry module  218  and stored in memory  206 . During pacemaker operation, the microprocessor  204  retrieves the maximum trigger delay from the memory  206  and uses it to set interval timer  210  after each triggering of the atrium sensor/stimulator. If the interval timer  208  expires, the microprocessor then triggers atrium sensor/stimulator  212 .  
         [0037]     Referring still to  FIG. 2 , the first interval timer  208  determines the delay between trigger signals applied to atrium stimulator  212  and ventricle stimulator  214 . The second interval timer  210  measures the time since the last heartbeat sensed by the atrium sensor/stimulator  212  or ventricle sensor/stimulator  214 . When either timer elapses, the elapsed timer asserts an interrupt signal to microprocessor  204  to notify the microprocessor  204  that the set amount of time has passed. Microprocessor  204  determines the source of the interrupt according to conventional techniques and takes the appropriate action. For example, if the maximum trigger delay (interval timer  210 ) has elapsed since the last heartbeat, the microprocessor  204  triggers atrium sensor/stimulator  212 .  
         [0038]     The microprocessor  204  also preferably monitors one or more physiological signals. In the pacemaker example, the microprocessor  204  detects cardiac voltage signals via atrium sensor  212  and/or ventricle sensor  214 . The heart leads which provide electrical pulses to the heart may also be used to sense electrical signals created by the heart as it beats, and these signals are used by the microprocessor  204  to adjust the timing of the electrical pulses. When other sensors are coupled to the implantable device  106 , the microprocessor can also monitor blood pressure, body temperature, oxygen levels, and other physiological parameters. The microprocessor  204  can also track its own performance, perhaps by logging the manner in which adaptation is performed on the parameters. The physiological signals and performance information can be logged in memory  206  for later retrieval by programming device  110 . The memory  206  preferably is large enough to store data regarding several physiological signals that being are monitored over a period of several days. Memory  206  preferably is implemented as dynamic random access memory (DRAM) or other suitable memory type.  
         [0039]     The atrium sensor/stimulator  212  is an interface circuit between microprocessor  204  and a heart lead coupled to an atrium of the heart. An interface circuit is necessary to allow the digital, low voltage microprocessor to control the high-energy pulses delivered to the heart, and additionally, to allow the microprocessor to monitor the analog electrical signals that are generated by the heart as it beats. Similarly, the ventricle sensor/stimulator  214  is an interface circuit between microprocessor  204  and a heart lead that couples to a ventricle of the heart. When atrium sensor/stimulator  212  receives a trigger signal from microprocessor  204 , it generates a shaped electrical energy pulse to the atrium. Likewise, when ventricle sensor/stimulator  212  receives a trigger signal from microprocessor  204 , it provides a shaped electrical energy pulse to the ventricle. If the microprocessor is using atrium sensor/stimulator  212  or ventricle sensor/stimulator  214  to measure cardiac voltage signals from the electrodes to monitor the performance of the heart, the microprocessor  204  stores the cardiac waveforms (or “electrograms”) in memory for subsequent retrieval by a medical technician.  
         [0040]     Telemetry module  218  may be designed to be activated by programming device  110  when wand  108  enters into proximity with pacer  106 . For example, the telemetry module  218  may continually be checking for an activation signal that the wand  108  transmits. Activation of the telemetry module  218  causes the telemetry module  218  to establish bidirectional communication with wand  108  and to notify microprocessor  204  of an incoming communication. As the wand  108  transmits a message signal, the telemetry module demodulates the message signal and delivers the incoming message to the microprocessor  204 . The microprocessor  204  decodes the incoming message and stores any received data or parameters. In addition, the microprocessor  204  responds to any received commands from the programming device  110 . For example, one command might be an “inquiry”, that is, a request for the microprocessor  204  to transfer configuration parameters from memory  206  to programming device  110 . In this case, microprocessor  204  provides the configuration parameters from memory  206  to telemetry module  218  for transferal to programming device  110 .  
         [0041]     Referring now to  FIG. 3 , programming device  110  includes a microprocessor  302 , a modulator  304  coupled to a transmit coil  306 , a demodulator  310  coupled to a receive sensor  308 , a memory  312 , and a user interface  314 . The microprocessor  302  responds to user input via the user interface  314  (which may comprise a graphic display and user input device such as a keypad) and initiates communications with pacer  106  ( FIG. 2 ). For example, if a user requests a download of data from the pacer to programming device  110 , microprocessor  302  formulates a command signal, and sends the signal to modulator  304 . Modulator  304  converts the command signal into a modulated signal for driving transmit coil  306 . The signal driving the transmit coil  306  produces a changing magnetic field which induces a current in a receive coil in the pacer. The pacer processes the induced current to reconstruct the information sent from the programming device, and formulates and sends a reply. The pacer can transmit signals to programming device  110  by various means including modulating a light signal or driving a transmit coil. Receive sensor  308  detects and amplifies the signal transmitted by the pacer to produce a detection signal. Demodulator  310  demodulates the detection signal and converts it into the data transmitted by the pacer  106 . Demodulator  310  then provides the data to microprocessor  302  for eventual analysis and display via user interface  314 . Memory  312  may be used to store data and configuration parameters downloaded from the pacer.  
         [0042]     Referring now to  FIG. 4 , a pair of flowcharts are provided to illustrate the operation of the processor  302  in the programming device  110  and the operation of the processor in  204  the implantable device  106  during the inquiry and programming operations. The programming device&#39;s processor  302  starts in step  401  and the implantable device&#39;s processor  204  starts in step  411 . In step  402  the processor  302  initiates an inquiry operation by sending a command to the implantable device requesting the implantable device to transmit its model and serial number. In step  403  the processor  302  receives the model and serial number information and stores it for future identification of the implantable device. In step  404  the processor  302  sends a request to the implantable device for the implantable device to transmit one or more of its configuration parameters. The parameter request may be a partial request, in which only certain specified parameters are requested, or a full request, in which a download of all the configuration parameters is requested. In a typical initial inquiry operation, the parameter request is a full request. In step  405  the processor  302  receives the transmitted configuration parameters and stores them in memory for analysis and possible alteration by the user of the programming device  110 . This may complete the inquiry operation, or as a further part of the inquiry operation the processor  302  may request and receive stored physiological data from the implantable device.  
         [0043]     After a user examines the configuration parameters and analyzes any downloaded data, the user may wish to modify one or more of the configuration parameters and to perform a programming operation to reprogram the implantable device with the modified parameters. In step  406  the processor  302  initiates a programming operation by sending a command to the implantable device requesting the implantable device to transmit its model and serial number. In step  407  the processor  302  receives the model and serial number information and verifies that it matches with the stored identification information from step  403 . The processor then in step  408  transmits the modified parameters. The programming device transmits a partial or complete parameter set to the implantable device. A partial parameter set is preferred for a faster programming operation, but a complete parameter set is preferred for added safety against incompatible configuration parameter settings. In step  409  the processor  302  receives confirmation from the implantable device that the transmitted parameters were successfully received. If confirmation is not received, in step  409 , then the user is notified of a failure to reprogram the implantable device. The processor  302  completes the programming operation by entering into end state  410 .  
         [0044]     In step  412  processor  204  of the implantable device receives the model and serial number request command sent by the programming device in step  402 . In step  413  the processor  204  responds by transmitting the model and serial number of the implantable device. In step  414  the processor  204  receives the configuration parameter request command from the programming device, and in step  415  the processor responds by transmitting the current configuration parameter values. Subsequently during a programming operation, the processor  204  receives another model and serial number request command in step  416 , and responds in step  417  by transmitting the model and serial number of the implantable device. Then in step  418  the processor  204  receives modified parameter values from the programming device. After verifying that the parameters have been correctly received, the processor updates the configuration parameters with the new values and, in step  419 , transmits a confirmation message to the programming device.  
         [0045]      FIG. 5  illustrates how the use of multiple programming devices can introduce safety concerns when a second programming device interacts with an implantable device between the inquiry and programming operations of the first programming device. An implantable device begins in step  502 . In step  504 , an inquiry operation is performed by a first programming device “A”. Subsequently, a second programming device “B” performs an inquiry operation on the implantable device in step  506 , and a programming operation on the implantable device in step  508 . The first programming device “A” is then used to program the implantable device in step  510 , and at the end of this sequence in step  512 , the implantable device may be left with an undesired set of configuration parameters. To avoid this, programming device “A” or the implantable device may be provided with a means for detecting if another programming device interacted with the implantable device between the inquiry and program operations of programming device “A”.  
         [0046]     A first embodiment of a multiple programming device-implantable device system is shown in  FIG. 6 . The programming device&#39;s processor  302  proceeds through the inquiry operation steps  401 - 405  as outlined previously. After the processor  302  successfully receives all the requested parameters in step  405 , in step  601  the processor  302  sends a programming device identification number to the implantable device for the implantable device to store. The programming device identification number preferably includes the model number and serial number of the programming device. In this system embodiment, the implantable device always has a record of the last programming device to successfully perform an inquiry or programming operation on it.  
         [0047]     Subsequently, when the programming device is ready to transmit altered parameters to the implantable device, the processor  302  proceeds through steps  406 ,  407 , and after verifying that the implant identification information matches, the processor transmits the programming device identification number in step  602  before transmitting the modified configuration parameters in step  408  and proceeding through steps  409  and  410 .  
         [0048]     The implantable device&#39;s processor  204  similarly proceeds through inquiry operation steps  411 - 415  as outlined previously. After the processor  204  transmits the requested parameters in step  415 , it receives and stores the programming device identification information in step  603 . Then when the programming device initiates a programming operation, the processor  204  performs steps  416 ,  417  before receiving the programming device&#39;s identification information in step  604 . In step  606  the processor  204  compares the received identification information to the previously stored identification information from step  603 . If they do not match, then in step  608  the processor  204  transmits a denial to the programming device and ends the programming operation in step  420 . If the information matches, then the processor  204  performs steps  418 - 420  to accept and confirm the modified parameters.  
         [0049]     This system embodiment provides that only the programming device which has most recently interacted successfully with the implantable device is allowed to program the implantable device. Referring back to  FIG. 5 , in step  510  this embodiment of programming device “A” would receive a denial from the implantable device when a programming operation is attempted. Programming device “A” would preferably inform the user of the denial and allow the user to initiate an inquiry operation to discover any alterations which may have been made to the configuration parameters.  
         [0050]     Another system embodiment is illustrated in  FIG. 7 . The inquiry operation of this embodiment matches that of the previous embodiment for both the programming device and the implantable device. After step  417  of the programming operation, the implantable device&#39;s processor  204  sends the programmer identification information to the programmer device in step  705 . Then in step  418 , the processor  204  receives any transmitted parameters and proceeds through steps  419 ,  420  as outlined previously.  
         [0051]     After step  407  of the programming operation the programming device&#39;s processor  302  receives in step  701  the identification information of the last programmer to interact with the implantable device. In step  703  the processor  302  verifies that the identification information matches the programming device&#39;s model and serial number. If they do not match, the processor  302  terminates the programming operation in step  410  and preferably notifies the user of the error. Otherwise, the processor proceeds through steps  408 - 410  of the programming operation to provide the modified parameters to the implantable device. This embodiment advantageously places fewer demands on the implantable device, thereby minimizing implementation cost.  
         [0052]     Another programming device embodiment is shown in  FIG. 8 . In this embodiment, after successfully receiving the configuration parameters in step  405 , the programming device&#39;s processor  302  starts a timer in step  801 . Subsequently, before initiating a transmission of altered parameters, the processor  302  checks for expiration of the timer in step  803 . If too much time has elapsed, the processor  302  aborts the programming operation and preferably notifies the operator. Otherwise, the processor  302  continues with the programming operation in steps  406 - 410 . An implantable device embodiment which operates similarly is shown in  FIG. 9 . After successfully completing transmission of requested parameters, the implantable device&#39;s processor  204  starts a timer in step  902 . After a programming operation is initiated, the processor  204  checks for expiration of the timer in step  904 . If too much time has elapsed, the processor  204  transmits a denial in step  906 , and the programming device preferably notifies the operator of the failure of the programming operation. Otherwise, the processor  204  continues the programming operation in steps  418 - 420 . In a variation on the embodiments of  FIGS. 8 and 9 , the timers may be restarted after successful completion of the programming operation. The timers in  FIGS. 8 and 9  preferably run for a time period greater than 5 minutes and less than 60 minutes. A time period of between 10 and 20 minutes is contemplated.  
         [0053]     Two more system embodiments are shown in  FIGS. 10 and 11 . These embodiments are closely related to those of  FIGS. 6 and 7 , respectively. However, rather than using the programming device&#39;s identification number to identify the programming devices, these embodiments use the time and date of last access to identify the programming devices.  
         [0054]     Referring now to  FIG. 10 , after the programming device&#39;s processor  302  successfully receives all the requested parameters in step  405 , in step  1001  the processor  302  stores and sends a current time and date to the implantable device for the implantable device to keep on record. Subsequently, when the processor  302  is instructed to send altered parameters to the implantable device, the processor  302  performs steps  406 ,  407  and then in step  1002  transmits the stored time and date to the implantable device before proceeding with the remaining steps  408 - 410 .  
         [0055]     The implantable device&#39;s processor  204  performs steps  411 - 415  of the inquiry operation and in step  1003  receives and stores the date and time transmitted by the programming device. In the subsequent programming operation the processor  204  performs steps  416 ,  417  before receiving the transmitted time and date from the programming device in step  1004 . Then in step  1006  the processor  204  compares the transmitted time and date to the stored time and date at which the last programming device successfully inquired or programmed the implantable device. If the numbers do not match, the processor  204  transmits a denial to the programming device in step  1008 . Otherwise the processor  204  proceeds to receive the new parameters in step  418 . Upon successful reception of all the transmitted parameters, the processor  204  sends a confirm signal in step  419  and stores the new parameters.  
         [0056]     Referring now to  FIG. 11 , the inquiry operations of both the programming device and implantable device are the same as those of  FIG. 10 . In step  1105 , the implantable device&#39;s processor  204  sends the stored date and time after establishing the implantable device&#39;s identity in steps  416 - 417 , and before performing the remaining programming steps  418 - 420 . After steps  406 - 407  of the programming operation, the programming device&#39;s processor  302  receives the date and time of last successful inquiry operation from the implantable device in step  1101 . In step  1103 , the processor  302  compares the received date and time to its own stored date and time of last successful operation to determine if any other programming device has successfully interacted with the implantable device since the current programming device&#39;s last inquiry operation. If the access date and times are the same, the processor  302  proceeds with steps  408 - 410  of the programming operation. Otherwise, the processor  302  terminates the program operation in step  410  and preferably notifies the user of the error.  
         [0057]     A preferred system embodiment is shown in  FIG. 12 . In this embodiment, a time and date is associated with the last successful programming of the implantable device  106 . After the programming device&#39;s processor  302  performs steps  401 - 405  of the inquiry operation, in step  1201  it receives and stores the time and date of the last programming operation on the implantable device. In any subsequent programming operation, the processor  302  establishes the identity of the implantable device in steps  406 - 407  and sends the stored time and date in step  1202  before sending any parameters in step  408 . After transmitting the parameters, the processor  302  sends the current date and time to the implantable device. The processor  302  then completes the programming operation steps  409 - 410 .  
         [0058]     After the implantable device&#39;s processor  204  performs inquiry operation steps  411 - 415 , it sends the time and date of the last programming operation in step  1204 . In the subsequent programming operation, the processor  204  establishes the implant&#39;s identity to the programming device in steps  416 - 417 . In step  1205 , the processor  204  receives the programming device&#39;s record of the last programming date and time, and compares it with the implantable device&#39;s record of the last programming date and time in step  1206 . If they do not match, then the implantable device has been reprogrammed since the last inquiry operation by the programming device, and the processor  204  transmits a denial in step  1208  and terminates the programming operation in step  420 . Otherwise, the is processor  204  accepts the new parameters in step  418 , and the current date and time in step  1210 . If the programming operation is successful, the implantable device stores the current date and time as the new programming date and time, and in step  419  sends a confirmation to the programming device.  
         [0059]     A more preferred embodiment is shown in  FIG. 13 . The inquiry operation is the same as the inquiry operation of the embodiment shown in  FIG. 12 . The programming operation differs for the implantable device in that after transmitting its identification information in step  417 , the processor  204  transmits the stored programming date and time to the programming device in step  1305 . The processor  204  then accepts any transmitted modified parameters in step  418  and if the transmission is successful, accepts and stores the current date and time in step  1210  before sending a confirmation in step  419 .  
         [0060]     The programming operation for the programming device begins with the processor  302  requesting and receiving the implantable device&#39;s identification information in steps  406 - 407 . In step  1301  the processor receives the transmitted date and time from the implantable device and in step  1303  compares the transmitted date and time to the stored programming date and time. If they match, then none of the configuration parameters has been re-programmed since the programming device&#39;s last inquiry operation. Consequently, the processor  302  proceeds to send the new parameters in step  408  and the current date and time in step  1203 . Otherwise, the programming device ends the program operation in step  410  and preferably notifies the operator of the error.  
         [0061]     The embodiments of  FIGS. 12 and 13  are preferred relative to the previously described embodiments since in these embodiments, multiple programming devices can simultaneously be qualified to provide a new set of parameters to the implantable device. Any programming device with a current version of the configuration parameters (as indicated by the associated programming date and time) can successfully program the implantable device. Conversely, in the other previously described embodiments, only a single programming device at a time (the one which has most recently interacted with the implantable device) can successfully program the implantable device.  
         [0062]     Referring now to  FIG. 14 , yet another embodiment is shown. In this embodiment, prior to each programming operation, programming device  110  inquires the configuration parameters in order to verify the accuracy of programming device  110 &#39;s copy of those parameters. The inquiry operations for the implantable device and the programming device is the same as that of  FIG. 4 . For the programming operation, the implantable device&#39;s processor  204  performs steps  416 - 417  to establish its identity to the programming device. Then in step  1406  the processor  204  receives a parameter request similar to that of step  414 , and in step  1407  responds to the parameter request by sending the requested parameters. Then in step  418  the processor  204  may receive modified parameters from the programming device, and in step  419  the processor  204  acknowledges a successful receipt of the parameters and updates the current parameters with the new parameter values.  
         [0063]     The programming device&#39;s processor  302  performs steps  406 - 407  to establish the implantable device&#39;s identity, then in step  1401 , the processor  302  transmits a request for the configuration parameters similar to that of step  404 . The processor  302  receives the transmitted parameters in step  1403  and in step  1405  compares them with the parameters from the previous inquiry. If there is no change (or only a slight change which may be attributed to adaptation or progression of a programmed algorithm), then the implantable device has not been reprogrammed since the inquiry. The processor  302  consequently transmits the new configuration parameters in step  408 . Otherwise, the programming device terminates the programming operation in step  410  and preferably notifies the user of the failure.  
         [0064]     Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.

Technology Classification (CPC): 0