Remotely enabled pacemaker and implantable subcutaneous cardioverter/defibrillator system

• US 20060241701A1
• Filed: 04/26/2005
• Published: 10/26/2006
• Est. Priority Date: 04/26/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Markowitz, H. Toby, Combs, William J., Sheldon, Todd J., Hettrick, Douglas A.
• Granted Patent: US 7,991,467 B2
• Time in Patent Office: Days
• US Class Current: 607/5
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Subcutaneous Implantable cardioverter-defibrillators (SubQ ICDS) are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion-defibrillation sense and stimulation electrodes for delivery of cardioversion-defibrillation shock and pacing therapies across the heart when necessary. The SubQ ICD is implemented with other implantable and external medical devices and communicates to provide drugs and therapy in a coordinated and synergistic manner.

Claims

1. A Synergistic system including a subcutaneous cardioverter/defibrillator (SubQ ICD) in bidirectional communication with one or more medical devices, the system comprising:

means for establishing communications with the SubQ ICD and one or more devices;

means for coordinating therapy delivery based on specific therapies; and

means for selecting a device among SubQ ICD, and the one or more medical devices based on the specific therapies.

2. The system of claim 1 wherein said SubQ ICD is subcutaneously implanted and includes a housing with an ovoid, kidney-shaped configuration and is implanted in the thorax over the ribs.

3. The system of claim 2 wherein said housing includes one ore more electrodes and further includes a connector block connecting the SubQ ICD to a subcutaneous lead inserted entirely subcutaneously or sub-muscularly.

4. The system of claim 1 wherein said one or more devices includes one of a pacemaker, an epicardial device, an AED, a life vest, a pressure measurement and a drug delivery device.

5. The system of claim 1 wherein said means for selecting includes means for disabling a non-selected device and placing it in a self-preserving precaution mode.

6. The system of claim 1 wherein said bi-directional communication includes automatic system function wherein a pacemaker, AED or other device communication to SubQ ICD includes wakeability and is communicable through RF, Bluetooth, WiFi, MICS wireless connection.

7. The system of claim 1 wherein the SubQ ICD is complemented with a new pacemaker upgraded to communicate with the SubQ ICD and provide additional therapy as needed.

8. An automatic system that enables selection between various devices including a SubQ ICD, pacemaker, AED, epicardial device, a wearable device, and a drug delivery device, the system comprising:

means for enabling bidirectional communication between at least two of the various devices;

means for verifying a therapy function for each one of the at least two of the various devices;

means for assessing a device status of each one of the at least two of the various devices; and

means for triggering therapy based on a specific capability of each one of the at least two of the various devices.

9. The system of claim 8 wherein said means for enabling bi-directional communication includes an RF signal.

10. The system of claim 8 wherein said means for triggering therapy includes associating means to verify detection of arrhythmias and physiologic signals from each one of the at least two of the various devices based on said specific capability.

11. The system of claim 8 wherein said means for triggering therapy includes means for identifying functions of each one of the at least two of the various devices.

12. The system of claim 8 wherein said epicardial device is powered by one of a small coil with a magnet, an RF charge super capacitor and accelerometer power source.

13. The system of claim 8 wherein said means for enabling bi-directional communication includes a screen integrated diagnostic.

14. The system of claim 8 wherein said epicardial device includes a hemodynamic sensor to sense at least one of perfusion (O₂ saturation), tissue color (O₂ saturation), pressure respiration, far-field R-wave and edema.

15. The system of claim 14 wherein said epicardial sensor includes at least one of nanoteeth/electrodes, a stretch sensor, a strain gauge and epicardial fixation.

16. The system of claim 8 wherein said SubQ ICD communicates with an AED and includes an algorithm for automatic connectivity.

17. The system of claim 8 wherein a remote data transfer device is implemented to uplink data to a remote programmer for processing data or a downlink to modify or update data in each one of the at least two of the devices.

19. The method of claim 13 wherein said confirming includes one of checking sensed events from each source to compare, EGM from IMD and ECG from SubQ ICD sense amplifier and detection algorithms, and alternatively cross checking the arrhythmia detection from signals from sensors associated with the SubQ ICD.

18. A method of detection and therapy delivery using a SubQ ICD and an IMD, the SubQ ICD being implanted subcutaneously or submuscularly entirely outside the thoracic cavity having no leads or electrodes within the thoracic cavity, and the IMD having an epicardial or endocardial lead, the method comprising:

measuring P-P, R-R and P-R intervals of signals from an EGM sense amplifier by the IMD;

detecting a potential arrhythmia with sensed data from the SubQ ICD;

sending an order to charge high voltage capacitors from the IMD to the SubQ ICD;

performing ATP by the IMD;

monitoring EGM signals from intracardiac leads to determine whether the arrhythmias was successfully terminated;

returning to a measuring/monitoring mode if arrhythmia termination is terminated;

sending a shock trigger signal to SubQ ICD if arrhythmia not terminated; and

providing post shock support by the IMD.

20. The method of claim 18 wherein said confirming includes using data from O₂ saturation collected by sensors at the IMD and SubQ ICD to confirm sensing and diagnosis of arrhythmia and/or optimization of the IMD and/or SubQ ICD parameters pertaining to A-V delay, rate and mode.

21. The method of claim 18 wherein said performing ATP and said sending a shock trigger and proceeded by a release of pre-pace or pre-shock drug release.

22. The method of claim 18 wherein said performing ATP and said sending a shock trigger are followed by post-pace or post-chock drug release.