Injectable Device for Physiological Monitoring

• US 20090076348A1
• 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: James, Kristofer, Wang, Jerry, Manicka, Yatheendhar D., Libbus, Imad, Amurthur, Badri, Bly, Mark, Mazar, Scott
• Granted Patent: US 8,684,925 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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 detecting device is provided for use in physiological monitoring. The device includes a plurality of sensors axially spaced along a body that provide an indication of at least one physiological event of a patient, a monitoring unit within the body coupled to the plurality of sensors configured to receive data from the plurality of sensors and create processed patient data, a power source within the body coupled to the monitoring unit, and a communication antenna external to the body coupled to the monitoring unit configured to transfer data to/from other devices.

Claims

1. An injectable device for use in physiological monitoring, comprising:

a plurality of sensors axially spaced along a body that provide an indication of at least one physiological event of a patient;

a monitoring unit within the body coupled to the plurality of sensors configured to receive data from the plurality of sensors and create processed patient data;

a power source within the body coupled to the monitoring unit; and

a communication antenna external to the body coupled to the monitoring unit configured to transfer data to/from other devices.

2. The device of claim 1, wherein the monitoring unit includes a processor.

3. The device of claim 2, wherein the processor includes program instructions for evaluating values received from the sensors with respect to acceptable physiological ranges for each value received by the processor and determine variances.

4. The device of claim 1, wherein the monitoring unit includes logic resources that determine heart failure status and predict impending decompensation.

5. The device of claim 1, wherein the monitoring unit is configured to perform one or more of, data compression, prioritizing of sensing by a sensor, cycling sensors, monitoring all or some of sensor data by all or a portion of the sensors, sensing by the sensors in real time, noise blanking to provide that sensor data is not stored if a selected noise level is determined, low-power of battery caching and decimation of old sensor data.

6. The device of claim 1, wherein the monitoring unit includes a notification device configured to provide notification when values received from the plurality of sensors are not within acceptable physiological ranges.

7. The device of claim 1, wherein the monitoring unit is configured to serve as a communication hub for multiple medical devices, coordinating sensor data and therapy delivery while transmitting and receiving data from a remote monitoring system.

8. The device of claim 1, wherein the monitoring unit is configured to deactivate selected sensors to reduce redundancy.

9. The device 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.

10. The device 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.

11. The device of claim 1, wherein the sensors are made of at least a material selected from, silicone, polyurethane, Nitinol, titanium, a biocompatible material, ceramics and a bioabsorbable material.

12. The system of claim 1, wherein at least a portion of sensors of the plurality of sensors have an insulative material selected from, PEEK, ETFE, PTFE, and polyimide, silicon, polyurethane.

13. The device of claim 1, wherein at least a portion of sensors of the plurality of sensors have openings or an absorbent material configured to sample a hydration level or electrolyte level in a surrounding tissue site of the plurality of sensors.

14. The device of claim 1, wherein the plurality of sensors includes current delivery electrodes and sensing electrodes.

15. The device of claim 1, wherein the outputs of the plurality of sensors is used to calculate and monitor blended indices.

16. The device of claim 15, wherein the blended indices include at least one of, heart rate (HR) or respiratory rate (RR) response to activity, HR/RR response to posture change, HR+RR, HR/RR+bioimpedance, and/or minute ventilation/accelerometer.

17. The device of claim 1, wherein the body and antenna are injectable in the patient by at least one of, catheter delivery, blunt tunneling, insertion with a needle, by injection, with a gun or syringe device with a stiffening wire stylet, guidewire, or combination of stylet or guidewire with a catheter.

18. The device of claim 1, wherein the body is flexible.

19. The device of claim 1, wherein at least a portion of the body has a drug eluting coating.

20. The device of claim 1, wherein the power source comprises a rechargeable battery transcutaneously chargeable with an external unit.