Injectable Physiological Monitoring System

• US 20090076401A1
• Filed: 09/12/2008
• Published: 03/19/2009
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis
• Inventors: Bly, Mark, Mazar, Scott
• Granted Patent: US 9,186,089 B2
• Time in Patent Office: Days
• US Class Current: 600/508
• 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

A system and method are provided for decompensation prediction of a heart failure patient with one or more injectable detecting systems communicating wirelessly with a remote monitoring system. The system includes one or more injectable detecting systems having a plurality of sensors that provide an indication of at least one physiological event of a patient, a wireless communication device coupled to the one or more injectable detecting systems and configured to transfer patient data directly or indirectly from the one or more injectable detecting systems to a remote monitoring system, and a remote monitoring system coupled to the wireless communication device, the remote monitoring system using processed data to determine heart failure status and predict impending decompensation of the patient.

Claims

1. A system for decompensation prediction of a heart failure patient, comprising:

one or more injectable detecting systems having a plurality of sensors that provide an indication of at least one physiological event of a patient;

a wireless communication device coupled to the one or more injectable detecting systems and configured to transfer patient data directly or indirectly from the one or more injectable detecting systems to a remote monitoring system; and

a remote monitoring system coupled to the wireless communication device, the remote monitoring system using processed data to determine heart failure status and predict impending decompensation of the patient.

2. The system of claim 1, wherein the one or more injectable detecting systems are inserted below the skin of the patient by at least one of, catheter delivery, blunt tunneling and needle insertion.

3. The system of claim 1, further comprising an imaging system to assist in guiding the injectable detecting system to a desired location.

4. The system of claim 1, wherein each of a sensor is selected from at least one of, bioimpedance, heart rate, heart rhythm, HRV, HRT, heart sounds, respiratory sounds, respiratory rate and respiratory rate variability, blood pressure, activity, posture, wake/sleep, orthopnea, temperature, heat flux and an accelerometer.

5. The system of claim 1, wherein each of a sensor is an activity sensor selected from at least one of, ball switch, accelerometer, minute ventilation, HR, bioimpedance noise, skin temperature/heat flux, BP, muscle noise and posture.

6. The system of claim 1, wherein the one or more injectable detecting systems include a power source, a memory, logic resources and an antenna.

7. The system of claim 6, wherein the power source is a rechargeable battery transcutaneously with an external unit.

8. The system of claim 1, wherein at least a portion of the one or more injectable detecting systems have a drug eluting coating.

9. The system of claim 1, wherein the one or more injectable detecting systems are anchored in the patient by at least one of, barbs, anchors, tissue adhesion pads, suture loops, shape of device, self-expanding metal structure, wherein self-expanding metal structure is made of Nitinol.

10. A system for decompensation prediction of a heart failure patient, comprising:

one or more injectable detecting systems having a plurality of sensors that provide an indication of at least one physiological event of a patient, the one or more injectable detecting systems being inserted below the skin of the patient, the one or more injectable detecting systems being injected below the skin of the patient by gun or syringe injection;

a wireless communication device coupled to the one or more injectable detecting systems and configured to transfer patient data directly or indirectly from the one or more injectable detecting systems to a remote monitoring system; and

a remote monitoring system coupled to the wireless communication device, the remote monitoring system using processed data to determine heart failure status and predict impending decompensation of the patient.

11. The system of claim 10, further comprising an imaging system to assist in guiding the one or more injectable detecting systems to a desired location.

12. The system of claim 10, wherein each of a sensor is selected from at least one of, bioimpedance, heart rate, heart rhythm, HRV, HRT, heart sounds, respiratory sounds, blood pressure, activity, posture, wake/sleep, orthopnea, temperature, heat flux and an accelerometer.

13. The system of claim 10, wherein each of a sensor is an activity sensors selected from at least one of, ball switch, accelerometer, minute ventilation, HR, bioimpedance noise, skin temperature/heat flux, BP, muscle noise and posture.

14. The system of claim 10, wherein the one or more injectable detecting systems include a power source, a memory, logic resources and an antenna.

15. The system of claim 10, wherein at least a portion of the one or more injectable detecting systems have a drug eluting coating.

16. The system of claim 10, wherein the one or more injectable detecting systems are anchored in the patient by at least one of, barbs, anchors, tissue adhesion pads, suture loops, shape of device, self-expanding metal structure, wherein self-expanding metal structure is made of Nitinol.

17. A method for decompensation prediction of a heart failure patient comprising:

injecting subcutaneously one or more injectable detecting systems having a plurality of sensors that provide an indication of at least one physiological event of a patient;

wirelessly transferring patient data directly or indirectly from the one or more injectable detecting systems to a remote monitoring system via a wireless communication device coupled to the one or more injectable detecting systems; and

processing the data using the remote monitoring system to determine heart failure status and predict impending decompensation of the patient.

18. The method of claim 17, wherein each of a sensor is selected from at least one of, bioimpedance, heart rate, heart rhythm, HRV, HRT, heart sounds, respiratory sounds, respiratory rate and respiratory rate variability, blood pressure, activity, posture, wake/sleep, orthopnea, temperature, heat flux, an accelerometer, hydration level or electrolyte level in a surrounding tissue site.

19. The method of claim 17, further comprising guiding the one or more injectable detecting system to a desired location with an imaging system.

20. An injection system for injecting one or more injectable physiological monitoring systems for use in physiological monitoring of a patient, the injection system comprising:

a body capable of holding one or more injectable physiological monitoring systems, the body having a proximal end and distal end, wherein the distal end is shaped to penetrate tissue;

a pusher configured to engage the one or more injectable physiological monitoring systems within the body; and

a movable handle coupled to a pusher configured to distally advance the one or more injectable physiological monitoring systems through the body.