Source: https://patents.google.com/patent/US9730601B2/en
Timestamp: 2019-07-19 11:10:27
Document Index: 222950707

Matched Legal Cases: ['art 12', 'Application No. 08794965', 'Application No. 07', 'Application No. 07', 'Application No. 07', 'Application No. 07', 'Application No. 07', 'Application No. 07', 'Application No. 08', 'Application No. 08']

US9730601B2 - Using multiple diagnostic parameters for predicting heart failure events - Google Patents
US9730601B2
US9730601B2 US14/629,027 US201514629027A US9730601B2 US 9730601 B2 US9730601 B2 US 9730601B2 US 201514629027 A US201514629027 A US 201514629027A US 9730601 B2 US9730601 B2 US 9730601B2
US14/629,027
US20150230722A1 (en
2008-07-31 Priority to US12/184,003 priority Critical patent/US9713701B2/en
2015-02-23 Application filed by Medtronic Inc filed Critical Medtronic Inc
2015-02-23 Priority to US14/629,027 priority patent/US9730601B2/en
2015-08-20 Publication of US20150230722A1 publication Critical patent/US20150230722A1/en
2015-09-15 Assigned to MEDTRONIC, INC. reassignment MEDTRONIC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SARKAR, SHANTANU, HETTRICK, DOUGLAS A, STADLER, ROBERT W
2017-08-15 Publication of US9730601B2 publication Critical patent/US9730601B2/en
This application is a continuation of U.S. patent application Ser. No. 12/184,003, filed Jul. 31, 2008 entitled “USING MULTIPLE DIAGNOSTIC PARAMETERS FOR PREDICTING HEART FAILURE EVENTS”, herein incorporated by reference in its entirety.
IMD 16 detects worsening heart failure in patient 14 based on one or both of the primary diagnostic parameters and the one or more secondary diagnostic parameters. In particular, IMD 16 detects worsening heart failure based only on the primary diagnostic parameter when an index that is changed over time based on the primary diagnostic parameter is outside of a threshold zone. That is, when the index has a value that is greater than the maximum threshold value of the threshold zone, the primary diagnostic parameter may alone be a reliable indictor that patient 14 is experiencing worsening heart failure. When the index has a value that is less than the minimum threshold value of the threshold zone, the primary diagnostic parameter may alone be a reliable indicator that patient 14 is not experiencing worsening heart failure.
If IMD 16 is configured to generate and deliver pacing pulses to heart 12, processor 80 may include pacer timing and control module, which may be embodied as hardware, firmware, software, or any combination thereof. The pacer timing and control module may comprise a dedicated hardware circuit, such as an ASIC, separate from other processor 80 components, such as a microprocessor, or a software module executed by a component of processor 80, which may be a microprocessor or ASIC. The pacer timing and control module may include programmable counters which control the basic time intervals associated with DDD, WI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes of single and dual chamber pacing. In the aforementioned pacing modes, “D” may indicate dual chamber, “V” may indicate a ventricle, “I” may indicate inhibited pacing (e.g., no pacing), and “A” may indicate an atrium. The first letter in the pacing mode may indicate the chamber that is paced, the second letter may indicate the chamber that is sensed, and the third letter may indicate the chamber in which the response to sensing is provided.
Initially, comparison module 160 compares fluid index value 140, which is determined based on the primary diagnostic parameter, e.g., intrathoracic impedance, as described above to threshold zone values 168. When the fluid index value is outside the range of the threshold zone values 168, i.e. grater than THRESHOLD_HIGH and less than THRESHOLD_LOW, the primary diagnostic parameter value is conclusive. That is, if the fluid index value is greater than THRESHOLD_HIGH, then comparison module 160 activates alert module 128. If, on the other hand, fluid index value 140 is less than THRESHOLD_LOW, IMD 16 continues to monitor patient 14.
Comparison module 160 determines the ratio of the median activity level to a baseline activity level, and compares the ratio to a first threshold value (activityFRACTION) and the median activity level to another threshold value (minACTIVITY) (264). The baseline activity level may be defined as the median activity level prior to the fluid index entering the threshold zone. The activityFRACTION threshold value may be computed as a predetermined or variable fraction of the previous median activity level, i.e., the median activity level prior to inclusion of the current daily value.
monitor at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient based on at least one signal from the at least one sensor;
change an index value over time based on the primary diagnostic parameter, wherein the index value is indicative of worsening heart failure of the patient;
detect worsening heart failure in the patient when the index value is greater than an upper threshold of a threshold zone, the upper threshold and a lower threshold defining the threshold zone;
determine whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index value is within the threshold zone; and
adjust the threshold zone.
determine that worsening heart failure is detected in the patient when the index value is greater than the upper threshold value, and
determine that worsening heart failure is not detected in the patient when the index value is less than the lower threshold value.
monitor a plurality of secondary diagnostic parameters, and
determine whether worsening heart failure is detected in the patient when the index value is inside the threshold zone and any of the secondary diagnostic parameters indicates worsening heart failure.
4. The system of claim 1, wherein the at least one sensor comprises one of a plurality of electrodes for detecting intrathoracic impedance as the primary diagnostic parameter or a pressure sensor for detecting a cardiovascular pressure as the primary diagnostic parameter.
5. The system of claim 1, wherein the at least one sensor comprises a plurality of electrodes, and the at least one secondary diagnostic parameter comprises one or more of atrial fibrillation (AF) burden, ventricular rate during AF, ventricular fibrillation (VF) burden, ventricular rate during VF, atrial tachyarrhythmia (AT) burden, ventricular rate during AT, ventricular tachyarrhythmia (VT), or ventricular rate during VT.
6. The system of claim 1, wherein the at least one sensor comprises an accelerometer, and the at least one secondary diagnostic parameter comprises activity level.
7. The system of claim 1, wherein the at least one sensor comprises a plurality of electrodes, and the at least one secondary diagnostic parameter comprises one or more of heart rate variability, night heart rate, difference between day heart rate and night heart rate, heart rate turbulence, or heart rate deceleration capacity.
8. The system of claim 1, wherein the at least one sensor comprises a plurality of electrodes, and the at least one secondary diagnostic parameter comprises one or more of respiratory rate, respiratory depth, or respiratory pattern.
9. The system of claim 1, wherein the at least one secondary diagnostic parameter comprises one or more of percentage of cardiac resynchronization pacing, baroreflex sensitivity, weight, blood pressure, metrics of renal function, medication history, or history of heart failure hospitalization.
10. The system of claim 1, further comprising an implantable medical device that houses the one or more processors, wherein the at least one sensor comprises at least one electrode located on an implantable medical lead coupled to the implantable medical device.
11. The system of claim 1, further comprising an implantable medical device, wherein the at least one sensor is at least one of within or coupled to the implantable medical device, and the implantable medical device comprises the one or more processors.
12. The system of claim 11, further comprising an external device that wirelessly communicates with the implantable medical device, wherein the one or more processors are configured to monitor the at least one secondary parameter based on information input by a user via the external device.
13. The system of claim 1, wherein the one or more processors automatically adjust the threshold zone as a function of time.
14. The system of claim 1, wherein the one or more processors provide an alert to a user in response to detecting worsening heart failure in the patient.
15. The system of claim 1, further comprising an implantable medical device that delivers a therapy to the patient, wherein the one or more processors automatically modify the therapy in response to detecting worsening heart failure in the patient.
16. The system of claim 15, wherein the therapy comprises at least one of a substance delivered by an implantable pump, cardiac resynchronization therapy, refractory period stimulation, or cardiac potentiation therapy.
17. The system of claim 1, wherein the index value is indicative of fluid accumulation of the patient.
18. The system of claim 1, wherein the one or more processors automatically adjust the threshold zone by one of increasing or decreasing at least one of the lower threshold or the upper threshold.
the one or more processors are configured to receive a signal indicative of input from a user via an external programmer,
the input requests adjustment of the threshold zone based on one or more symptoms of the patient, and
the one or more processors are configured to adjust, based on the signal indicative of the input, at least one of the lower threshold or the upper threshold that defines the threshold zone.
20. The system of claim 1, wherein the one or more processors are configured to automatically adjust the threshold zone based on one or more monitored diagnostic parameters indicative of patient condition, wherein the one or more monitored diagnostic parameters comprise at least one of the at least one primary diagnostic parameter or the at least one secondary diagnostic parameter.
21. The system of claim 1, wherein the one or more processors are configured to automatically adjust the threshold zone based on efficacy of identifying worsening heart failure.
22. The system of claim 1, wherein the one or more processors are configured to:
determine that the index value is below the lower threshold; and
responsive to determining that the index value is below the lower threshold, adjust the threshold zone.
23. The system of claim 1, further comprising a subcutaneously implantable device that comprises the at least one sensor.
24. A computer-readable medium comprising instructions that cause one or more processors to:
monitor at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient;
means for monitoring at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient;
means for changing an index value over time based on the primary diagnostic parameter, wherein the index value is indicative of worsening heart failure of the patient;
means for detecting worsening heart failure in the patient when the index value is greater than an upper threshold of a threshold zone, the upper threshold and a lower threshold defining the threshold zone;
means for determining whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index value is within the threshold zone; and
means for adjusting the threshold zone.
detect worsening heart failure in the patient when the index value is greater than an upper threshold of a threshold zone, the upper threshold and a lower threshold defining the threshold zone; and
determine whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index value is within the threshold zone.
US14/629,027 2008-07-31 2015-02-23 Using multiple diagnostic parameters for predicting heart failure events Active 2028-08-28 US9730601B2 (en)
US12/184,003 US9713701B2 (en) 2008-07-31 2008-07-31 Using multiple diagnostic parameters for predicting heart failure events
US14/629,027 US9730601B2 (en) 2008-07-31 2015-02-23 Using multiple diagnostic parameters for predicting heart failure events
US15/676,567 US10299693B2 (en) 2008-07-31 2017-08-14 Using multiple diagnostic parameters for predicting heart failure events
US12/184,003 Continuation US9713701B2 (en) 2008-07-31 2008-07-31 Using multiple diagnostic parameters for predicting heart failure events
US15/676,567 Continuation US10299693B2 (en) 2008-07-31 2017-08-14 Using multiple diagnostic parameters for predicting heart failure events
US20150230722A1 US20150230722A1 (en) 2015-08-20
US9730601B2 true US9730601B2 (en) 2017-08-15
US12/184,003 Active 2032-07-29 US9713701B2 (en) 2008-07-31 2008-07-31 Using multiple diagnostic parameters for predicting heart failure events
US14/629,027 Active 2028-08-28 US9730601B2 (en) 2008-07-31 2015-02-23 Using multiple diagnostic parameters for predicting heart failure events
US15/676,567 Active US10299693B2 (en) 2008-07-31 2017-08-14 Using multiple diagnostic parameters for predicting heart failure events
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SARKAR, SHANTANU;HETTRICK, DOUGLAS A;STADLER, ROBERT W;SIGNING DATES FROM 20081007 TO 20081009;REEL/FRAME:036568/0525