Command sequencing and interlocks for a remotely programmable implantable device

Abstract

Methods of providing a digital program request formatted by a remotely-located server are provided. In one embodiment, the method includes the steps of providing an identifier associated with an implantable medical device (IMD) to the remotely-located server to acquire the digital program request intended for the IMD, and validating the digital program request using a digital identification code uniquely identifying the server. In response to successful validation of the digital program request, the program request is added to a storage queue for subsequent wireless transmission to the IMD. A sequential code contained within the digital program request is compared to a second sequential code earlier processed by the IMD to verify that the digital program request is not processed out-of-order. The results of the validating step are stored in a notification queue for subsequent transmittal to the server.

1 . A method of providing a digital program request formatted by a remotely-located server to an implantable medical device (IMD) having an identifier associated therewith, the digital format request containing a sequential code indicating a desired order in which the digital program request is to be processed, the method comprising the steps of:
 providing the identifier to the remotely-located server to acquire the digital program request intended for the IMD;   validating the digital program request using a digital identification code uniquely identifying the server;   in response to successful validation of the digital program request, adding the program request to a storage queue associated with the IMD for subsequent wireless transmission to the IMD;   comparing the sequential code contained within the digital program request to a second sequential code earlier processed by the IMD to verify that the digital program request is not processed out-of-order; and   storing a result of the validating step in a notification queue for subsequent transmittal to the server.   
   
   
       2 . The method of  claim 1  wherein the digital program request is one of a plurality of program requests intended for the IMD, each of the plurality of program requests associated with a sequential code assigned by the server. 
   
   
       3 . The method of  claim 2  wherein at least one of the plurality of program requests is a cancellation request having a sequential code that is greater than the sequential code assigned to a previous program request, and wherein the method further comprises the step of canceling the previous program request following successful validation of the cancellation request. 
   
   
       4 . The method of  claim 2  wherein the method comprises repeating the validating, adding and storing steps for each of the plurality of program requests. 
   
   
       5 . The method of  claim 1  wherein the providing step comprises synchronizing a clock to a system clock present on the server. 
   
   
       6 . The method of  claim 1  further comprising the step of determining a proper value of an operating parameter for the IMD based at least in part upon information contained in the program request and information received from the IMD. 
   
   
       7 . The method of  claim 1  further comprising the steps of:
 establishing a wireless connection to the IMD;   further validating the program request in the storage queue using the digital identification code uniquely identifying the server and the identifier associated with the IMD;   upon successful validation, transferring the program request to the IMD via the wireless connection; and   storing the results of the further validation step in the notification queue for subsequent transmittal to the server.   
   
   
       8 . A remote monitoring device comprising a processor and a digital storage medium, the digital storage medium having executable instructions stored thereon that are configured to execute the method of  claim 1 . 
   
   
       9 . A remote monitoring device for facilitating communication between a server and an implantable medical device (IMD) having an identifier associated therewith, the remote monitoring device comprising:
 a wireless interface configured to communicate with the IMD;   a network interface configured to communicate with the server; and   a processor configured to execute a software application adapted to: (i) obtain the identifier from the IMD via the wireless interface, (ii) provide the identifier to the server via the network interface to acquire the digital program request intended for the IMD, (iii) validate a digital identification code uniquely identifying the server contained within the digital program request, (iv) add the validated program request to a storage queue associated with the IMD for subsequent wireless transmission to the IMD via the wireless interface, and (v) store responses to the server in a notification queue for subsequent transmittal to the server via the network interface.   
   
   
       10 . The remote monitoring device of  claim 9  wherein the remote monitoring device further comprises a memory configured to store safety parameter data related to the IMD. 
   
   
       11 . The remote monitoring device of  claim 10  wherein the program request includes instructions for modifying at least one operating parameter of the IMD, and wherein the software application is further adapted to: (i) compare the instructions included within the digital program request to the stored safety parameter data, and (ii) cancel the instructions if the instructions are inconsistent with the safety parameter data stored on the remote monitoring device. 
   
   
       12 . The remote monitoring device of  claim 11  wherein the stored safety parameter data comprises at least one of the group consisting of an allowed dose, an allowed does interval, an allowed activation dose, and an allowed activation does interval. 
   
   
       13 . The remote monitoring device of  claim 9  wherein the software application is further adapted to: (i) identify a sequential code indicating a desired order in which the digital program request is to be processed, and (ii) compare the sequential code contained within the digital program request to a second sequential code earlier processed by the remote monitoring device to verify that the digital program request is not processed out-of-order. 
   
   
       14 . The remote monitoring device of  claim 9  further comprising:
 a memory storing plurality of program requests for the IMD each having a sequential code assigned by the server;   wherein the software application is further adapted to: (i) determine if one of the plurality of program requests is a cancellation request having a sequential code that is greater than the sequential code assigned to a previous program request, and (ii) cancel the previous program request following successful validation of the cancellation request.   
   
   
       15 . A method of providing a digital program request formatted by a remotely-located server to an implantable medical device (IMD) having an identifier associated therewith, the remotely-located server storing safety parameter data related to the IMD, the digital program request including instructions for modifying at least one operating parameter of the IMD, the method comprising the steps of:
 providing the identifier to the remotely-located server to acquire the digital program request intended for the IMD;   validating the digital program request using a digital identification code uniquely identifying the server;   comparing the instructions included within the digital program request to stored safety parameter data stored on the IMD; and   adding the program request to a storage queue associated with the IMD for subsequent wireless transmission to the IMD if: (i) the digital program request is successfully validated, and (ii) if the instructions are consistent with the safety parameter data stored on the IMD.   
   
   
       16 . The method of  claim 15  wherein the remotely-located server is configured to communicate with a browser application operable by a caregiver, and wherein the method further comprises the step of providing notice to the caregiver via the browser application if the instructions are inconsistent with the stored safety parameter data. 
   
   
       17 . The method of  claim 15  wherein the IMD is configured to communicate with the remotely-located server via a monitor (IRM) also storing safety parameter data, and wherein the method further comprises the steps of:
 comparing the instructions included within the digital program request to the safety parameter data stored on the IRM; and   canceling the instructions if the instruction are inconsistent with the safety parameter data stored on the IRM.   
   
   
       18 . The method of  claim 15  wherein the safety parameter data stored on the IMD comprises at least one of the group consisting of an allowed dose, an allowed does interval, an allowed activation dose, and an allowed activation does interval.