Implantable cardiac devices and methods

• US 9,002,449 B2
• Filed: 02/21/2014
• Issued: 04/07/2015
• Est. Priority Date: 01/21/2011
• Status: Active Grant

• Current Assignee: Neurocardiac Innovations, LLC
• Original Assignee: Neurocardiac Innovations, LLC
• Inventors: Kameli, Nader
• Primary Examiner(s): Voorhees, Catherine
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US14/186,696
• Publication Number:
  US 20140172048A1
• Time in Patent Office: 410 Days
• Field of Search: 607/27, 607/29
• US Class Current: 607/2
• CPC Class Codes: A61M 2230/62 Posture
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36535 controlled by body position or posture
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/39624 Pain reduction therapy
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence

Abstract

Embodiments relate to an implantable cardiac system, including a housing, electronic circuitry for controlling one or more of power management, processing unit, information memory and management circuit, sensing and simulation output. The system also includes diagnosis and treatment software for diagnosing health issues, diagnosing mechanical issues, determining therapy output and manage patient health indicators over time, a power supply system including at least one rechargeable battery, a recharging system, an alarm (or alert) system to inform patient of energy level and integrity of system, communication circuitry, one or more electrodes for delivering therapeutic signal to a heart and one or more electrodes for from delivering electrocardiogram signal from the heart to the electronic circuitry. The power sources can include rechargeable batteries. The housing can include receptacles that receive a probe that mechanically and electrically connects to circuitry to recharge the device and receive data from the device.

Claims

1. An implantable medical device comprising:

one or more batteries; and

medical device circuitry comprising;

therapy circuitry configured to deliver therapy to the patient;

battery monitoring circuitry configured to determine whether at least one battery has exceeded a battery life threshold; and

expiration circuitry configured to (i) determine whether the medical device circuitry has exceeded one or more expiration thresholds, the one or more expiration thresholds comprising a final expiration threshold indicating that the medical device circuitry has exceeded its operational life and (ii) prevent the medical device from delivering the therapy to the patient in response to determining that the medical device circuitry has exceeded the final expiration threshold.

2. The implantable medical device of claim 1, wherein the therapy circuitry is configured to deliver at least one of (i) cardiac pacing, (ii) cardiac defibrillation, (iii) electrical stimulation for management of pain, (iv) electrical stimulation for treatment of obesity, (v) electrical stimulation for treatment of a neurological ailment, (vi) electrical stimulation for treatment of a physical disability, (vii) chemical release for treatment of pain, (viii) chemical release for treatment of a physiological ailment or (ix) chemical release for treatment of a neurological ailment.

3. The implantable medical device of claim 1, wherein the final expiration threshold indicating that the medical device circuitry has exceeded its operational life is based on at least one of:

(i) a fixed period of time after the medical device is implanted into the patient, (ii) an amount of therapy applied to the patient, (iii) a predetermined timeframe after a first delivery of therapy, or (iv) a predetermined expiration date.

4. The implantable medical device of claim 3, wherein the predetermined expiration date is set by a manufacturer of the medical device.

5. The implantable medical device of claim 1, further comprising:

alert circuitry configured to generate at least one alert in response to the expiration circuitry determining that the medical device circuitry has exceeded or is about to exceed at least one of the one or more expiration thresholds.

6. The implantable medical device of claim 5, wherein the at least one alert is at least one of (i) an audible alert, (ii) a vibration alert, or (iii) a signal sent to an external computing device.

7. The implantable medical device of claim 1, wherein the one or more expiration thresholds further comprise at least one pre-final threshold indicating that the medical device circuitry will exceed its operational life within a predetermined timeframe.

8. The implantable medical device of claim 7, further comprising:

alert circuitry configured to generate at least one of (i) a pre-final alert in response to the expiration circuitry determining that the medical device circuitry has exceeded the at least one pre-final threshold and (ii) a final alert in response to the expiration circuitry determining that the medical device circuitry has exceeded the final expiration threshold.

9. The implantable medical device of claim 1, wherein the expiration circuitry is configured to disable the therapy circuitry when the expiration circuitry determines that the medical device circuitry has exceeded the final expiration threshold, thereby rendering the implantable medical device unable to deliver therapy to the patient.

10. The implantable medical device of claim 9, wherein the medical device circuitry further comprises:

patient monitoring circuitry configured to monitor one or more physiological signals of the patient, wherein the patient monitoring circuitry is configured to operate both before and after the expiration circuitry has disabled the therapy circuitry as long as the one or more batteries have sufficient charge to operate the patient monitoring circuitry.

11. The implantable medical device of claim 1, wherein the expiration circuitry comprises termination circuitry configured to disconnect the medical device circuitry from the one or more batteries, thereby rendering the entire implantable medical device inoperable.

12. The implantable medical device of claim 1, further comprising:

one or more therapy electrodes through which the therapy circuitry delivers the therapy to the patient; and

wherein the expiration circuitry comprises termination circuitry configured to disconnect the medical device circuitry from the one or more therapy electrodes, thereby rendering the implantable medical device unable to deliver therapy to the patient via the one or more therapy electrodes.

13. The implantable medical device of claim 1, further comprising:

one or more capacitors electrically coupled to the one or more batteries and configured store electric charge for delivering the therapy to the patient; and

wherein the expiration circuitry comprises termination circuitry configured to disconnect the one or more capacitors from the one or more batteries, thereby rendering the implantable medical device unable to deliver therapy to the patient.

14. The implantable medical device of claim 1, wherein the expiration circuitry comprises termination circuitry configured to irreversibly prevent the therapy circuitry from delivering therapy to the patient.

15. The implantable medical device of claim 14, wherein the termination circuitry comprises at least one of a fuse or a switch.

16. The implantable medical device of claim 1, wherein the expiration circuitry is configured to prevent the medical device from delivering the therapy to the patient by sending a corresponding disable signal to the therapy circuitry.

17. A method comprising:

determining whether one or more batteries in a medical device implanted in a patient has exceeded a battery life threshold;

generating a battery life warning in response to determining that the battery life threshold has been exceeded;

determining whether medical device circuitry in the implanted medical device has exceeded one or more expiration thresholds, the one or more expiration thresholds comprising a final expiration threshold indicating that the medical device circuitry has exceeded its operational life; and

preventing the implanted medical device from delivering therapy to the patient in response to determining that the medical device circuitry has exceeded the final expiration threshold.

18. The method of claim 17, wherein the therapy comprises at least one of (i) cardiac pacing, (ii) cardiac defibrillation, (iii) electrical stimulation for management of pain, (iv) electrical stimulation for treatment of obesity, (v) electrical stimulation for treatment of a neurological ailment, (vi) electrical stimulation for treatment of a physical disability, (vii) chemical release for treatment of pain, (viii) chemical release for treatment of a physiological ailment or (ix) chemical release for treatment of a neurological ailment.

19. The method of claim 17, wherein the final expiration threshold is based on at least one of:

(i) a fixed period of time after the medical device is implanted into the patient, (ii) an amount of therapy applied to the patient, (iii) a predetermined timeframe after a first delivery of therapy, or (iv) a predetermined expiration date.

20. The method of claim 19, wherein the predetermined expiration date is set by a manufacturer of the medical device.

21. The method claim 17, further comprising:

generating at least one alert in response to determining that the medical device circuitry has exceeded or is about to exceed at least one of the one or more expiration thresholds.

22. The method of claim 21, wherein the at least one alert is at least one of (i) an audible alert, (ii) vibration alert or (iii) a signal sent to an external computing device.

23. The method of claim 17, wherein the one or more expiration thresholds further comprise at least one pre-final threshold indicating that the medical device circuitry will exceed its operational life within a predetermined timeframe.

24. The method of claim 23, further comprising:

generating at least one of (i) a pre-final alert in response to determining that the medical device circuitry has exceeded the at least one pre-final threshold and (ii) a final alert in response to determining that the medical device circuitry has exceeded the final expiration threshold.

25. The method of claim 17, wherein preventing the implanted medical device from delivering therapy to the patient in response to determining that the medical device circuitry has exceeded the final expiration threshold comprises disabling therapy circuitry of the implanted medical device, thereby rendering the implanted medical device unable to deliver therapy to the patient.

26. The method of claim 25, further comprising:

monitoring one or more physiological signals of the patient both before and after the step of disabling the therapy circuitry, as long as the one or more batteries have sufficient charge to operate monitoring circuitry configured to monitor the one or more physiological signals.

27. The method of claim 17, wherein preventing the implanted medical device from delivering therapy to the patient in response to determining that the medical device circuitry has exceeded the final expiration threshold comprises disconnecting the medical device circuitry from the one or more batteries, thereby rendering the entire implanted medical device inoperable.

28. The method of claim 17, wherein preventing the implanted medical device from delivering therapy to the patient in response to determining that the medical device circuitry has exceeded the final expiration threshold comprises disconnecting the medical device circuitry from one or more therapy electrodes, thereby rendering the implanted medical device unable to deliver therapy to the patient via the one or more therapy electrodes.

29. The method of claim 17, wherein preventing the implanted medical device from delivering therapy to the patient in response to determining that the medical device circuitry has exceeded the final expiration threshold comprises disconnecting a set of one or more capacitors of the implanted medical device from the one or more batteries of the implanted medical device, thereby rendering the implanted medical device unable to deliver therapy to the patient.

30. The method of claim 17, wherein preventing the implanted medical device from delivering therapy to the patient in response to determining that the medical device circuitry has exceeded the final expiration threshold comprises at least one of (i) activating or deactivating a switch, (ii) sending a disable signal, or (iii) blowing a fuse.