US2021127973A1PendingUtilityA1

System and method for patient medical care initiation based on implantable medical device data with the aid of a digital computer

Assignee: BARDY DIAGNOSTICS INCPriority: Jul 3, 2019Filed: Jan 11, 2021Published: May 6, 2021
Est. expiryJul 3, 2039(~12.9 yrs left)· nominal 20-yr term from priority
G16H 80/00G16H 40/67G16H 50/20H04L 12/2825A61B 5/0022A61B 5/14551A61B 5/14532A61B 5/29A61B 5/0816A61B 2560/0204A61B 5/076A61B 5/6861A61B 2562/0219A61B 2560/0468A61B 5/0031A61B 5/0205A61B 5/14552H04Q 2209/43A61B 5/021A61B 2560/0219H04Q 2209/886A61B 5/0006A61B 5/287H04Q 9/02A61B 5/073A61B 5/087H04Q 9/00A61B 5/02055
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Claims

Abstract

An implantable medical device is disclosed. A housing includes a hollow body forming a first electrode on an outer surface with end caps affixed to opposite ends, one end cap forming a second electrode. A microcontroller circuit is provided and includes a microcontroller operable under program instructions stored within a non-volatile memory device. An analog front end is interfaced to the electrodes to sense electrocardiographic signals. A transceiver circuit is operable to wirelessly communicate with an external data device. The program instructions define instructions to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory device to the external data device. A diagnostic overread of the samples can be performed using medical diagnostic criteria and medical care initiated with one of pre-identified care providers based on the overread.

Claims

exact text as granted — not AI-modified
1 . A system for patient medical care initiation based on implantable medical device data with the aid of a digital computer, comprising:
 an implantable medical device, comprising:
 a housing on which a first and a second electrode are formed; and 
 a microcontroller circuit circumferentially provided within the housing and comprising a microcontroller operable under program instructions stored within a non-volatile memory device, further comprising:
 an analog front end electrically interfaced to the first and the second electrodes and operable to sense electrocardiographic signals; and 
 a transceiver circuit operable to wirelessly communicate with a download station; 
 
 the program instructions defining instructions for the microcontroller to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory to the download station via the transceiver circuit; 
 the download station configured to receive the samples from the transceiver circuit; 
   at least one computer, comprising:
 a database configured to store the received samples and medical diagnostic criteria; and 
 a processor and a memory configured to store code executable by the processor, the processor configured to:
 generate a diagnostic overread of the samples using the medical diagnostic criteria; and 
 initiate medical care of the patient with one or more pre-identified care providers based on the overread. 
 
   
     
     
         2 . A system according to  claim 1 , wherein the diagnostic overread comprises one or more diagnostic findings that are rated by degrees of severity. 
     
     
         3 . A system according to  claim 2 , the processor further configured to:
 compare the ratings of the diagnostic findings to a threshold, wherein the initiation of the medical care comprises generating orders to seek immediate treatment based on the comparison.   
     
     
         4 . A system according to  claim 1 , the processor further configured to at least one of:
 notify a general practice physician upon one of the diagnostic findings comprising normal physiological data despite patient complaints of light headedness or syncope;   notify a cardiologist upon one of the diagnostic findings comprising atrial fibrillation of over 1 minute duration, ectopy comprising more than 3 PVCs per minute, palpitations comprising fluttering of the chest, and supraventricular tachycardia comprising heart rates over 180 bpm; and   notify an electrophysiologist upon one of the diagnostic findings comprising ventricular tachycardia comprising 3 or more consecutive abnormal ventricular beats, bradycardia comprising pauses greater than 3 seconds, and heart blockage comprising the non-conduction of any normal sinus beat.   
     
     
         5 . A system according to  claim 1 , the processor further configured to:
 generate a referral to one such care provider if the diagnostic findings comprises a medical condition not found in the patient's medical history; and   engage proactive health care management if the diagnostic findings comprises a medical condition found in the patient's medical history.   
     
     
         6 . A system according to  claim 1 , the processor further configured to:
 obtain physiological data associated with a population of individuals similar to the patient, wherein the diagnostic overread is further generated based on physiological data associated with the population of individuals similar to the patient.   
     
     
         7 . A system according to  claim 1 , wherein at one of:
 the received samples are structured along a temporal spectrum that reflects a change in the received samples over time; and   the received samples are structured on a per event basis.   
     
     
         8 . A system according to  claim 1 , wherein each of the medical diagnostic criteria are associated with at least one of a class of health conditions and a specific medical condition. 
     
     
         9 . A system according to  claim 8 , wherein the classes of medical conditions comprise cardiac disorder, respiratory distress, hypoglycemia, and hypoxia. 
     
     
         10 . A system according to  claim 1 , wherein the implantable medical device further collects additional physiology of the patient and the diagnostic overread is further made based on the additional physiology. 
     
     
         11 . A method for patient medical care initiation based on implantable medical device data with the aid of a digital computer, comprising:
 performing an electrocardiographic monitoring using an implantable medical device, comprising: a housing on which a first and a second electrode are formed and a microcontroller circuit circumferentially provided within the housing and comprising a microcontroller operable under program instructions stored within a non-volatile memory device, the microcontroller circuit further comprising an analog front end electrically interfaced to the first and the second electrodes and operable to sense electrocardiographic signals, the implantable medical device further comprising a transceiver circuit operable to wirelessly communicate with a download station, the program instructions defining instructions for the microcontroller to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory to the download station via the transceiver circuit;   receiving by the download station the samples from the transceiver circuit;   storing by a database configured the received samples and medical diagnostic criteria;   generating by a processor, the processor interfaced to a memory and configured to execute code, a diagnostic overread of the samples using the medical diagnostic criteria; and   initiating by the processor medical care of the patient with one or more pre-identified care providers based on the overread.   
     
     
         12 . A method according to  claim 11 , wherein the diagnostic overread comprises one or more diagnostic findings that are rated by degrees of severity. 
     
     
         13 . A method according to  claim 12 , further comprising:
 comparing the ratings of the diagnostic findings to a threshold, wherein the initiation of the medical care comprises generating orders to seek immediate treatment based on the comparison.   
     
     
         14 . A method according to  claim 11 , further comprising at least one of:
 notifying by the processor a general practice physician upon one of the diagnostic findings comprising normal physiological data despite patient complaints of light headedness or syncope;   notifying by the processor a cardiologist upon one of the diagnostic findings comprising atrial fibrillation of over 1 minute duration, ectopy comprising more than 3 PVCs per minute, palpitations comprising fluttering of the chest, and supraventricular tachycardia comprising heart rates over 180 bpm; and   notifying by the processor an electrophysiologist upon one of the diagnostic findings comprising ventricular tachycardia comprising 3 or more consecutive abnormal ventricular beats, bradycardia comprising pauses greater than 3 seconds, and heart blockage comprising the non-conduction of any normal sinus beat.   
     
     
         15 . A method according to  claim 11 , further comprising:
 generating by the processor a referral to one such care provider if the diagnostic findings comprises a medical condition not found in the patient's medical history; and   engaging by the processor proactive health care management if the diagnostic findings comprises a medical condition found in the patient's medical history.   
     
     
         16 . A method according to  claim 11 , further comprising:
 obtaining by the processor physiological data associated with a population of individuals similar to the patient, wherein the diagnostic overread is further generated based on physiological data associated with the population of individuals similar to the patient.   
     
     
         17 . A method according to  claim 11 , wherein at one of:
 the received samples are structured along a temporal spectrum that reflects a change in the received samples over time; and   the received samples are structured on a per event basis.   
     
     
         18 . A method according to  claim 11 , wherein each of the medical diagnostic criteria are associated with at least one of a class of health conditions and a specific medical condition. 
     
     
         19 . A method according to  claim 18 , wherein the classes of medical conditions comprise cardiac disorder, respiratory distress, hypoglycemia, and hypoxia. 
     
     
         20 . A system according to  claim 11 , wherein the implantable medical device further collects additional physiology of the patient and the diagnostic overread is further made based on the additional physiology.

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