Analyte sensor and medicant delivery data evaluation and error reduction apparatus and methods

Abstract

Apparatus and methods for error modeling and correction in one or both of (i) a partially or fully implanted or non-implanted medicant delivery mechanism (such as a pump), and (ii) implanted physiologic parameter sensor. In one exemplary embodiment, the apparatus and methods employ a training mode of operation, whereby the apparatus conducts “machine learning” to model one or more errors (e.g., unmodeled variable system errors) associated with the medicant dose calculation process, and (ii) generation of a medicant delivery operational model (based at least in part on data collected/received in the training mode), which is applied to correct or compensate for the errors during normal operation of the sensor and pump system. This enhances accuracy of medicant delivery, such as over the lifetime of an implanted pump at a single implantation site, or during multiple relocations of a transcutaneously implanted pump), and enables “personalization” of the pump to each user.

What is claimed is: 
     
         1 .- 20 . (canceled) 
     
     
         21 . Computerized apparatus comprising:
 at least one data interface configured to enable at least communication of data with (i) a medicant delivery device configured to deliver medicant to a living being, and (ii) a sensor apparatus implanted within the living being;   processing apparatus in data communication with the at least one data interface; and   a storage apparatus in data communication with the processing apparatus, the storage apparatus comprising instructions configured to, when executed by the processing apparatus, cause the computerized apparatus to:
 receive data relating to operation of the medicant delivery device in a first uncorrected mode; 
 cause generation of an error correction operational model based at least in part on the received data; 
 cause receipt of sensor data generated by the implanted sensor apparatus; 
 utilize at least the sensor data and the error correction operational model to estimate one or more unmodeled errors associated with delivery of the medicant, and produce at least one compensation for the estimated one or more unmodeled errors. 
   
     
     
         22 . The computerized apparatus of  claim 21 , wherein the at least one compensation for one or more unmodeled errors associated with the delivery comprises compensation for one or more physiological error sources particular to the living being to which the medicant is to be delivered. 
     
     
         23 . The computerized apparatus of  claim 22 , wherein the one or more errors vary as a function of at least an ambulatory context of the living being. 
     
     
         24 . The computerized apparatus of  claim 22 , wherein the one or more errors vary as a function of at least a dietary or food ingestion context of the living being. 
     
     
         25 . The computerized apparatus of  claim 21 , wherein the sensor apparatus comprises a blood analyte sensor apparatus, and wherein the instructions are further configured to, when executed by the processing apparatus, cause the computerized apparatus to:
 (i) cause operation of the blood analyte sensor apparatus in a first sensor operating mode;   (ii) based at least in part on the operating of the blood analyte sensor apparatus in the first sensor operating mode, cause generation of a sensor error correction operational model, and   (iii) subsequent to the generation of the sensor error correction operation model, cause operation of the blood analyte sensing apparatus in a second mode whereby corrected blood analyte data is generated based at least on the sensor error correction operation model.   
     
     
         26 . The computerized apparatus of  claim 21 , wherein the instructions are further configured to, when executed by the processing apparatus, cause the medicant dosing apparatus to:
 subsequent to the generation of the error correction operational model, cause operation of the medicant delivery device in a medicant dispensing mode, the medicant dispensing mode including application of the error correction operation model on at least a portion of then-current blood analyte signal data generated by the implanted sensor apparatus.   
     
     
         27 . The computerized apparatus of  claim 21 , wherein:
 the implanted sensor apparatus comprises a BLE (Bluetooth Low Energy) wireless data interface, the at least one data interface of the computerized apparatus configured to wirelessly communicate with the implanted sensor apparatus using the BLE wireless data interface.   
     
     
         28 . The computerized apparatus of  claim 27 , wherein:
 the computerized apparatus comprises a portable user device further comprising at least one wireless network data interface, the at least one wireless network data interface configured to allow wireless data communication between the portable user device and at least one wireless access node of a wireless network so as to enable data communication between an application computer program configured to execute on the portable user device and at least one networked server apparatus, the at least one networked server apparatus configured to cause:   performance of one or more machine learning algorithms in support of the generation of an error correction operational model; and   transmission of data relating to the performance of the one or more machine learning algorithms to the application computer program.   
     
     
         29 . The computerized apparatus of  claim 21 , wherein the generated error correction operational model is specific to the living being. 
     
     
         30 . The computerized apparatus of  claim 21 , wherein:
 the computerized apparatus is further configured to receive data, via at least one network data interface, relating to one or more other living beings; and   the generation of the error correction operational model is based at least in part on the received data relating to the one or more other living beings.   
     
     
         31 . The computerized apparatus of  claim 21 , wherein:
 the received sensor data generated by the implanted sensor apparatus comprises at least one of (i) data generated by a calibration data source, or (ii) uncorrected data that has been corrected via a calibration source; and   the plurality of instructions are further configured to, when executed, cause the computerized apparatus to apply the at least one compensation for the estimated one or more unmodeled errors to data generated by the medicant delivery device as part of operation thereof in a second, corrected mode.   
     
     
         32 . The computerized apparatus of  claim 21 , wherein:
 the received sensor data generated by the implanted sensor apparatus comprises both (i) uncorrected sensor data, and (ii) data generated by a calibration data source; and   the plurality of instructions are further configured to, when executed, cause the computerized apparatus to cause generation of a second error correction operational model based at least on the received (i) uncorrected sensor data and (ii) data generated by the calibration data source, the second error correction operational model configured to estimate one or more unmodeled errors associated with the sensor apparatus, and produce at least one compensation for the estimated one or more unmodeled errors associated with the sensor apparatus.   
     
     
         33 . The computerized apparatus of  claim 32 , wherein the produced at least one compensation for the estimated one or more unmodeled errors associated with the sensor apparatus are further utilized by the computerized apparatus to generate the error correction operational model associated with the medicant delivery device. 
     
     
         34 . Non-transitory computer readable apparatus comprising a storage medium, the storage medium comprising a plurality of instructions which are configured to, when executed on a computerized apparatus, cause:
 receipt of first data relating to operation of a medicant delivery device in a first uncorrected mode, the medicant delivery device configured to deliver medicant to a living being;   receipt of second data relating to operation of a sensor apparatus, the sensor apparatus configured for implantation within the living being;   generation of an error correction operational model based at least in part on the received first data; and   utilization of at least the second data and the error correction operational model to generate third data, the third data configured to correct for one or more unmodeled errors associated with delivery of the medicant by the medicant delivery device.   
     
     
         35 . The non-transitory computer readable apparatus of  claim 34 , wherein the plurality of instructions are further configured to cause, when executed, transmission of at least a portion of the third data to a second computerized apparatus associated with the living being, such that the transmitted at least portion of the third data can be applied by the second computerized apparatus to correct for the one or more unmodeled errors associated with the delivery of the medicant by the medicant delivery device; and
 wherein the second computerized apparatus associated with the living being comprises a portable computerized device in wireless data communication with both the sensor apparatus and the medicant delivery device.   
     
     
         36 . The non-transitory computer readable apparatus of  claim 34 , wherein:
 the plurality of instructions are further configured to cause, when executed, transmission of at least a portion of the first data to a second computerized apparatus via a network interface, the second computerized apparatus comprising computing apparatus configured to use at least one machine learning (ML) algorithm to generate ML data; and   the causation of the generation of the error correction operational model comprises causing the computing apparatus to utilize the transmitted at least portion of the first data to generate the error correction operational model, the generation of the error correction operational model based at least in part on the ML data.   
     
     
         37 . The non-transitory computer readable apparatus of  claim 36 , wherein the plurality of instructions are further configured to cause, when executed:
 receipt of data comprising the generated error correction operational model;   the generation of the third data based at least on the received data comprising the generated error correction operational model and the second data; and   transmission of at least a portion of the third data to a third computerized apparatus associated with the living being, the third data configured to enable the correction for the one or more unmodeled errors.   
     
     
         38 . The non-transitory computer readable apparatus of  claim 36 , wherein the third computerized apparatus associated with the living being comprises at least one of an implanted or transcutaneous medicant delivery device of the living being. 
     
     
         39 . Computerized apparatus, comprising:
 a data interface in communication with a medicant delivery device and a sensor apparatus;   processing apparatus in data communication with the data interface; and   a storage apparatus in data communication with the processing apparatus, the storage apparatus comprising at least one computer program having a plurality of instructions configured to, when executed by the processing apparatus, cause the computerized apparatus to at least:
 cause operation of the medicant delivery device in a mode whereby one or more calculations relating to medicant delivery to a living being are uncorrected; 
 cause operation of the sensor apparatus in a mode whereby one or more calculations relating to blood analyte level of the living being are uncorrected; 
 based at least in part on the operation of the medicant delivery device in the mode, cause generation of a first error correction model relating to the medicant delivery device; 
 based at least in part on the operation of the sensor apparatus in the mode, cause generation of a second error correction model relating to the sensor apparatus; 
 cause application of the first error correction model to at least a portion of then-current data relating to medicant delivery, the application of the first error correction operational model enabling predictive correction of one or more errors associated with delivery of the medicant; and 
 cause application of the second error correction model to at least a portion of then-current signal data generated by the sensor apparatus, the application of the second error correction operational model enabling predictive correction of one or more sensor-related errors. 
   
     
     
         40 . The computerized apparatus of  claim 39 , wherein the plurality of instructions are further configured to, when executed by the processing apparatus, cause the computerized apparatus to at least, based on a determination that one or more criteria for sensor re-training are met, initiate a repeat of the operation of the sensor apparatus in the mode whereby the one or more calculations relating to blood analyte level of the living being are uncorrected.