Injectable physiological monitoring system

• US 9,538,960 B2
• Filed: 10/23/2015
• Issued: 01/10/2017
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Inventors: Mazar, Scott T., Bly, Mark J.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/921,827
• Publication Number:
  US 20160045169A1
• Time in Patent Office: 445 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 2562/16 Details of sensor housings or probes; Details of structural supports for sensors A61B2560/0462 takes precedence
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

An injectable device for use in a subcutaneous physiological monitoring of a patient includes a body, a plurality of sensors, and a monitoring unit. The plurality of sensors provide an indication of at least one physiological event of a patient, wherein the plurality of sensors includes two or more electrodes in contact with tissue of the patient. The monitoring unit is located within the body and is coupled to the plurality of sensors and configured to monitor a physiologic signal of the patient using the electrodes, wherein the physiologic signal includes an impedance signal related to hydration of tissue of the patient and wherein the monitoring unit is further configured to, based at least in part on the impedance signal measured from the patient, detect an impending cardiac decompensation of the patient.

Claims

1. An injectable device for use in subcutaneous physiological monitoring of a patient, the injectable device comprising:

a body;

a plurality of sensors that provide an indication of at least one physiological event of a patient, wherein the plurality of sensors include current delivery electrodes and sensing electrodes in contact with tissue of the patient and spaced along the body of the injectable device; and

a monitoring unit located within the body and coupled to the plurality of sensors and configured to monitor a bioimpedance of the patient using the current delivery electrodes and sensing electrodes, wherein the monitoring unit utilizes the monitored bioimpedance to determine a hydration of surrounding tissue and wherein the monitoring unit is further configured to, based at least in part on the determined hydration, detect an impending cardiac decompensation of the patient.

2. The injectable device of claim 1, further including electrocardiogram circuitry coupled to the two or more electrodes to measure an electrocardio gram signal of the patient.

3. The injectable device of claim 2, wherein the monitoring unit utilizes the measured impedance signal to monitor a respiration signal associated with the patient.

4. The injectable device of claim 3, wherein the monitoring unit compares the monitored hydration, the respiration signal and the electrocardiogram signal to baseline values established for each, wherein the monitoring unit sets a flag indicating cardiac decompensation based on a combination of the compared values.

5. The injectable device of claim 1, further including an accelerometer located within the body that generates an activity signal in response to at least one of a activity or a position of the patient.

6. The injectable device of claim 5, wherein the accelerometer is a three-axis accelorometer configured to measure at least one inclincation, a position, an orientation, and an acceleration of the patient in three dimensions.

7. The injectable device of claim 5, wherein the accelerometer is comprised of at least one of a piezoelectric accelerometer, a capacitive accelerometer, or an electromechanical accelerometer.

8. The injectable device of claim 5, wherein the monitoring unit utilizes activity data received from the accelerometer to detect physiological events and identify patient states when data collection is desirable.

9. The injectable device of claim 8, wherein patient states in which data collection is desirable include rest states.

10. The injectable device of claim 1, wherein the body has a proximal end and a distal end, wherein the distal end is shaped to penetrate tissue.

11. The injectable device of claim 1, wherein the injectable device can be inserted in the patient in one or more of a non-sterile setting, sterile setting, non-surgical setting, and surgical setting.

12. An injectable device for use in subcutaneous physiological monitoring of a patient, the injectable device comprising:

a hermetically sealed body;

a plurality of sensors that provide an indication of at least one physiological event of a patient, wherein the plurality of sensors includes an accelerometer located within the body that generates an activity signal in response to at least one of a activity or a position of the patient and at least two electrodes spaced along the hermetically sealed body of the injectable device and in contact with tissue of the patient for monitoring a physiological signal associated with the patient; and

a monitoring unit located within the body and coupled to the accelerometer and the at least two electrodes, wherein the at least two electrodes are utilized to measure an impedance signal related, wherein the monitoring unit utilizes the measured impedance to determine a hydration of surrounding tissue of the patient and wherein the monitoring unit is further configured to, based at least in part on the determined hydration and the activity level of the patient, detect an impending cardiac decompensation of the patient.

13. The injectable device of claim 12, wherein the accelerometer is a three-axis accelorometer configured to measure at least one inclincation, a position, an orientation, and an acceleration of the patient in three dimensions.

14. The injectable device of claim 12, wherein the monitoring unit utilizes the monitored activity level of the patient to identify patient states when data collection is appropriate.

15. The injectable device of claim 14, wherein patient states in which data collection is appropriate includes rest states.

16. The injectable device of claim 12, further including electrocardiogram circuitry coupled to the two or more electrodes to measure an electrocardiogram signal of the patient.

17. The injectable device of claim 16, wherein the monitoring unit utilizes the measured impedance signal to monitor a respiration signal associated with the patient.

18. The injectable device of claim 16, wherein the monitoring unit compares the monitored hydration, the respiration signal and the electrocardiogram signal to baseline values established for each, wherein the monitoring unit sets a flag indicating cardiac decompensation based on a combination of the compared values.