Methods for operating a system for management of implantable medical devices and related systems

Abstract

In one embodiment, a method for operating a system for management of implantable medical devices (IMDs), comprises conducting communication sessions with a plurality of clinician programmer devices while the clinician programmer devices are engaged in respective programming sessions with IMDs; receiving and storing second programming data from a plurality of clinician programmer devices, wherein the second programming data was created during programming sessions with IMDs without network connectivity to the system for management of IMDs; reconciling programming of the plurality of IMDs that were programmed with the second programming data with data stored by the system for management of IMDs; and communicating second signed validation data to cause IMDs to conduct therapeutic operations according to programming data validated by respective instances of second validation data.

1 .- 20 . (canceled) 
     
     
         21 . A method for management of implantable medical devices (IMDs), comprising:
 receiving, by a system for management of IMDs, programming data from a clinician programmer device, wherein the programming data was previously created during a programming session between the clinician programmer device and an IMD without network connectivity to the system for management of IMDs;   reconciling, by the system for management of IMDs, programming of the IMD programmed with the programming data with data stored by the system for management of IMDs;   generating, by the system for management of IMDs, validation data corresponding to the programming data, wherein the validation data is signed with a key corresponding to the IMD; and   communicating, by the system for management of IMDs, the validation data to the IMD, the validation data configured to enable the IMD to conduct therapeutic operations according to the programming data.   
     
     
         22 . The method of  claim 21 , wherein the programming data comprises one or more parameters for controlling a therapy for treating a patient via the IMD, the one or more parameters comprising at least one parameter selected from the list consisting of: a pulse amplitude parameter, a pulse frequency parameter, a pulse pattern parameter, a timing parameter, a frequency parameter, a stimulation pattern, and a pacing delay parameter. 
     
     
         23 . The method of  claim 21 , wherein the validation data is communicated to the IMD via the clinician programmer device. 
     
     
         24 . The method of  claim 21 , wherein the validation data is communicated to the IMD via a patient controller device. 
     
     
         25 . The method of  claim 21 , wherein the data stored by the system for management of IMDs is received from a patient controller device. 
     
     
         26 . The method of  claim 21 , wherein the reconciling comprises:
 comparing the programming data received from the clinician programming device with the data stored by the system for management of IMDs, wherein the data stored by the system for management of IMDs is received from a patient controller device subsequent to generation of the programming data;   determining, based on the comparing, whether the programming data corresponds to the data stored by the system for management of IMDs; and   generating the validation data in response to a determination that the programming data corresponds to the data stored by the system for management of IMDs.   
     
     
         27 . The method of  claim 26 , further comprising:
 generating revocation data in response to a determination that a particular instance of programming data does not correspond to data stored by the system for management of IMDs; and   communicating the revocation data to a particular IMD associated with the particular instance of the programming data to prevent use of the particular instance of the programming data.   
     
     
         28 . The method of  claim 21 , further comprising receiving metadata corresponding to the programming data received from the clinician programmer device, wherein the metadata accompanies the programming data and includes information associated with a clinician that created the programming data, information that identifies the clinician programmer, information that identifies one or more modifications to parameters of the IMD during the programming session, information identifying a physical location where the programming session occurred, information associated with time and date of the programming session, or a combination thereof. 
     
     
         29 . The method of  claim 21 , further comprising generating the signed validation data using an encryption key corresponding to the IMD. 
     
     
         30 . The method of  claim 21 , further comprising:
 receiving information associated with a second programming session from the clinician programmer device, the second programming session comprising second programming data corresponding to a second IMD, wherein the second programming session is performed while network connectivity to the system for management of IMDs is available, and wherein the second programming data is received from the clinician programmer during the second programming session;   reconciling the second programming data with second data stored by the system for management of IMDs;   generating second validation data corresponding to the second programming data, wherein the second validation data is signed with a key corresponding to the second IMD; and   communicating the second validation data to the second IMD, wherein the second validation data is configured to enable the second IMD to conduct therapeutic operations according to the second programming data.   
     
     
         31 . A system for management of implantable medical devices (IMDs), comprising:
 a memory configured to store programming data associated with a plurality of IMDs; and   one or more processors communicatively coupled to the memory, the one or more processors configured to:
 receive programming data from a patient controller device corresponding to an IMD of the plurality of IMDs, wherein the programming data was previously created during a programming session between a clinician programmer device and the IMD without network connectivity to the system for management of IMDs; 
 reconcile programming of the IMD programmed with the programming data with data corresponding to the IMD stored at the memory; 
 generate validation data corresponding to the programming data, wherein the validation data is signed with a key corresponding to the IMD; and 
 communicate the validation data to the IMD, wherein the validation data is configured to enable the IMD to conduct therapeutic operations according to the programming data. 
   
     
     
         32 . The system of  claim 31 , wherein the programming data comprises one or more parameters for controlling a therapy for treating a patient via the IMD, the one or more parameters comprising at least one parameter selected from the list consisting of: a pulse amplitude parameter, a pulse frequency parameter, a pulse pattern parameter, a timing parameter, a frequency parameter, a stimulation pattern, and a pacing delay parameter. 
     
     
         33 . The system of  claim 31 , wherein the validation data is communicated to the IMD via the patient controller device. 
     
     
         34 . The system of  claim 31 , wherein the data stored by the system for management of IMDs is received from a clinician programmer device. 
     
     
         35 . The system of  claim 31 , wherein the reconciling comprises:
 comparing the programming data received from the patient controller device with the data stored by the system for management of IMDs, wherein the data stored by the system for management of IMDs is received from the clinician programming device subsequent to generation of the programming data;   determining, based on the comparing, whether the programming data corresponds to the data stored by the system for management of IMDs; and   generating the validation data in response to a determination that the programming data corresponds to the data stored by the system for management of IMDs.   
     
     
         36 . The system of  claim 35 , wherein the one or more processors are configured to:
 generate revocation data in response to a determination that a particular instance of programming data does not correspond to data stored by the system for management of IMDs; and   communicate the revocation data to a particular IMD associated with the particular instance of the programming data to prevent use of the particular instance of the programming data.   
     
     
         37 . The system of  claim 31 , wherein the one or more processors are configured to receive, from the clinician programmer device, metadata corresponding to the data stored by the system for management of IMDs, wherein the metadata includes information associated with a clinician that created the programming data, information that identifies the clinician programmer, information that identifies one or more modifications to parameters of the IMD during the programming session associated with creation of the programming data, information identifying a physical location where the programming session occurred, information associated with time and date of the programming session, or a combination thereof. 
     
     
         38 . The system of  claim 31 , wherein the one or more processors are configured to generate the validation data using an encryption key corresponding to the IMD. 
     
     
         39 . The system of  claim 31 , wherein the one or more processors are configured to receive information associated with a second programming session from the clinician programmer device, the second programming session comprising at least second programming data corresponding to a second IMD of the plurality of IMDs. 
     
     
         40 . The system of  claim 39 , wherein the second programming session is performed while network connectivity to the system for management of IMDs is available, wherein the second programming data is received from the clinician programmer during the second programming session, and wherein the one or more processors are configured to:
 reconcile the second programming data with second data stored by the system for management of IMDs;   generate second validation data corresponding to the second programming data, wherein the second validation data is signed with a key corresponding to the second IMD; and   communicate the second validation data to the second IMD, wherein the second validation data is configured to enable the second IMD to conduct therapeutic operations according to the second programming data.