Implantable cardiac devices and methods with body orientation unit

• US 9,907,972 B2
• Filed: 01/21/2011
• Issued: 03/06/2018
• 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): Carey, Michael
• Application Number:
  US13/011,801
• Publication Number:
  US 20120191151A1
• Time in Patent Office: 2,601 Days
• Field of Search: 607 4, 607 5, 607 6, 607 10, 607 17
• CPC Class Codes: A61N 1/36535 controlled by body position or posture
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/378 Electrical supply
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: A61N 1/39622 Pacing therapy

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 present embodiments further include a body orientation unit to determine body position and use same to control therapy.

Claims

1. An implantable cardiac device, comprising:

one or more cardiac sensors configured to detect a cardiac episode of a patient, wherein the cardiac episode comprises a ventricular tachycardia, a ventricular fibrillation, or a sudden cardiac death episode of the patient, wherein detecting the ventricular fibrillation or sudden cardiac death episode indicates a need for application of a defibrillation signal;

a body orientation unit configured to determine a physical orientation of at least a portion of a patient'"'"'s body;

alarm circuitry configured to, in response to the one or more cardiac sensors detecting that the patient has experienced a ventricular fibrillation or a sudden cardiac death episode, notify the patient that application of the defibrillation signal is imminent; and

therapy circuitry configured to, after the alarm circuitry has notified the patient that application of the defibrillation signal is imminent;

(i) apply the defibrillation signal to the patient in response to determining that (a) the patient has experienced a ventricular fibrillation or a sudden cardiac death episode indicating a need for application of the defibrillation signal and (b) the patient is in a substantially horizontal position; and

(ii) refrain from applying the defibrillation signal to the patient in response to determining that, even though the patient has experienced a ventricular fibrillation or sudden cardiac death episode, the patient is in a substantially vertical position.

2. The implantable cardiac device of claim 1, wherein the body orientation unit includes an accelerometer.

3. The implantable cardiac device of claim 2, wherein the accelerometer includes at least one of a capacitive device, a MEMS device, a plurality of two-axis devices, a single three-axis device, and a six-axis device, which are configured to output a signal indicative of an orientation of a patient.

4. The implantable cardiac device of claim 1, wherein the body orientation unit includes an inclinometer.

5. The implantable cardiac device of claim 4, wherein the inclinometer includes at least one of a capacitive device and a MEMS device, which are configured to output a signal indicative of an orientation of a patient.

6. The implantable cardiac device of claim 1, wherein the body orientation unit includes a gyrometer.

7. The implantable cardiac device of claim 6, wherein the gyrometer includes at least one of a MEMS device and a three-axis device, which can output a signal indicative of an orientation of a patient.

8. The implantable cardiac device of claim 1, wherein the therapy circuitry is configured to deliver only a defibrillation signal.

9. The implantable cardiac device of claim 1, wherein, in operation, the therapy circuitry does not make pacing determinations and does not deliver pacing signals.

10. The implantable cardiac device of claim 1, further comprising:

a plurality of energy sources, wherein the energy sources include a first high-voltage capacitor, a second high-voltage capacitor, and at least one rechargeable battery, and

energy management circuitry, wherein the energy management circuitry is configured to (i) control use of the rechargeable battery to perform capacitor formation on the first and second high-voltage capacitors, one at a time, and (ii) cycle charge between the first and second high-voltage capacitors.

11. The implantable cardiac device of claim 10, wherein the energy management circuitry is configured to cycle charge through the first and second high-voltage capacitors before storing the charge back in the rechargeable battery.

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

a plurality of energy sources, wherein the energy sources include a first high-voltage capacitor, a second high-voltage capacitor, and a rechargeable battery configured for use in a capacitor reformation process, wherein the rechargeable battery is large enough in capacity to at least double the size of energy held on one of the first or second high-voltage capacitors, and wherein the rechargeable battery is configured to charge the first and second high-voltage capacitors for defibrillation shock delivery in response to the one or more cardiac sensors detecting a need for a defibrillation shock signal.

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

a plurality of energy sources; and

energy management circuitry configured to ensure substantial separation of the energy sources and to substantially prevent flow of current from one energy source to the other energy source.

14. The implantable cardiac device of claim 1, further comprising:

a first housing containing (i) electronic circuitry associated with the one or more cardiac sensors and (ii) a first energy source, and

a second housing containing (i) the therapy circuitry and (ii) a second energy source, and

wherein the first housing and the second housing are in electrical communication with each other.

15. The implantable cardiac device of claim 14, wherein the first housing and the second housing are electrically coupled by at least one of a cable, set of one or more wires, a set of one or more leads, or any combination thereof.

16. The implantable cardiac device of claim 15, wherein the first housing and the second housing are wirelessly connected to each other.

17. The implantable cardiac device of claim 14, wherein the second housing contains a rechargeable battery and wherein the second housing comprises an external connector configured to deliver charge to the rechargeable battery from outside the second housing.

18. The implantable cardiac device of claim 14, wherein the electronic circuitry associated with the one or more cardiac sensors is electrically connected to the patient via a lead configured to sense and assess patient parameters, and wherein the therapy circuitry in the second housing is electrically connected to the patient, and wherein the electronic circuitry associated with the one or more cardiac sensors and the therapy circuitry can be replaced independent of the other.

19. The implantable cardiac device of claim 14, further comprising:

communication circuitry; and

a header comprising a port that includes a probe receptacle configured to receive a probe that pierces through skin of the patient and makes direct connection with the probe receptacle, wherein the probe receptacle is communicatively coupled to the communication circuitry, and wherein after receiving the probe, the probe receptacle is configured to facilitate electrical communication of at least one of control signals, data exchange, and charge delivery to and/or from the implantable cardiac device and one or more external devices via the probe.

20. The implantable cardiac device of claim 1, further comprising:

a first housing including electronic circuitry associated with the one or more cardiac sensors; and

a second housing including communication circuitry configured to receive charge and control commands, and

wherein the first housing and the second housing are in electrical communication with each other.

21. The implantable cardiac device of claim 20, wherein the second housing includes a port configured to receive a probe that pierces through skin of a patient and makes direct connection with a probe receptacle, wherein after the probe is directly connected to the probe receptacle, the probe receptacle is configured to facilitate electrical communication of at least one of the control commands, data exchange, and/or charge to and/or from the implantable cardiac device and one or more external devices via the probe.

22. The implantable cardiac device of claim 21, wherein the probe includes a needle with electrically conductive segments.

23. The implantable cardiac device of claim 10, wherein the energy management circuitry is further configured to manage the plurality of energy sources to charge one or more of the first and second high-voltage capacitors in less than about 7 seconds to get a defibrillation shock ready for delivery to the patient.

24. The implantable cardiac device of claim 1, wherein the therapy circuitry includes a switch to terminate therapy delivery in response to receiving an external signal.

25. The implantable cardiac device of claim 24,

wherein the switch can be activated by an external magnet during a time the alarm circuitry is notifying the patient of an imminent application of the defibrillation signal.

26. The implantable cardiac device of claim 25, wherein the switch can be activated by an internal system based on position of the body of the patient, or level of activity of the body of the patient, or detection of physiological activity of internal organs of the patient, or any combination thereof.

27. The implantable cardiac device of claim 1, wherein the implantable cardiac device has only one or two defibrillation energy levels.

28. The implantable cardiac device of claim 1, wherein the implantable cardiac device has one defibrillation energy level and the said defibrillation energy level set at 40 J.

29. The implantable cardiac device of claim 1, wherein the therapy circuitry includes a processor configured to receive orientation data from the body orientation unit and to control delivery of the defibrillation signal to the patient.

30. The implantable cardiac device of claim 29, wherein the therapy circuitry includes one or more capacitors to supply energy for the defibrillation signal and capacitor reformation circuitry.

31. The implantable cardiac device of claim 29, wherein the one or more cardiac sensors includes sensors configured to connect to leads, the sensors configured to analyze a heart signal and indicate an abnormal heart rhythm.

32. The implantable cardiac device of claim 1, further comprising a housing that includes a data storage system in the housing configured to store device performance data and patient related data.

33. The implantable cardiac device of claim 1, wherein the implantable cardiac device further comprises:

one or more housings;

one or more energy sources;

energy management circuitry configured to manage the one or more energy sources and energy stored therein; and

capacitor reformation circuitry configured to perform capacitor reformation; and

wherein the therapy circuitry is configured to deliver cardiac defibrillation therapy, and wherein the therapy circuitry is not configured to provide pacing signals.

34. The implantable cardiac device of claim 33, wherein the one or more housings enclose at least one of the one or more cardiac sensors and at least a portion of the therapy circuitry, and wherein the implantable cardiac device further comprises:

one or more leads that connect the one or more cardiac sensors and the therapy circuitry to heart tissue of the patient, and wherein the one or more leads are configured to detect cardiac signals and to deliver a defibrillation signal to the heart tissue.

35. The implantable cardiac device of claim 33, wherein at least one of the one or more housings includes one or more headers configured to connect to components outside the at least one housing.

36. The implantable cardiac device of claim 33, wherein at least one housing includes at least one high voltage capacitor configured to store and deliver high voltage defibrillation energy to the patient.

37. The implantable cardiac device of claim 33, wherein at least one energy source is a primary, non-rechargeable battery.

38. The implantable cardiac device of claim 33, wherein at least one energy source is a rechargeable battery.

39. The implantable cardiac device of claim 38, wherein the energy management circuitry comprises recharging circuitry in at least one of the one or more housings, and wherein the at least one housing includes a recharging port to receive electrical energy from outside the at least one housing.

40. The implantable cardiac device of claim 39, wherein the recharging port includes a connector in the at least one housing through which an external charge generation system can directly connect to the implantable cardiac device.

41. The implantable cardiac device of claim 40, wherein the recharging circuitry includes a magnetic coil configured to receive electromagnetic charge from an external electromagnetic charge generating system.

42. The implantable cardiac device of claim 33, wherein the one or more energy sources include a primary battery and a rechargeable battery.

43. The implantable cardiac device of claim 42, wherein the primary battery and the rechargeable battery are packaged separately for leak prevention and safety inside at least one housing of the one or more housings.

44. The implantable cardiac device of claim 43, wherein the at least one housing enclosing the rechargeable battery also contains charge regulation circuitry configured to manage a recharging process.

45. The implantable cardiac device of claim 42, wherein the one or more energy sources are packaged together inside the at least one housing.

46. The implantable cardiac device of claim 42, wherein:

the primary battery is configured to power at least the one or more cardiac sensors, the body orientation unit, and the alarm circuitry, and

the rechargeable battery is configured to power one or more high-voltage capacitors and deliver a cardiac defibrillation signal.

47. The implantable cardiac device of claim 46, wherein:

while the implantable cardiac device is applying the defibrillation signal to the patient, the rechargeable battery is configured to continuously deliver the cardiac defibrillation signal to the patient;

the rechargeable battery is configured to be recharged from outside the one or more housings; and

the primary battery is not used for applying the cardiac defibrillation signal to the patient.

48. The implantable cardiac device of claim 46, wherein the primary battery is large enough to last an entire life of the implantable cardiac device, and the rechargeable battery has sufficient electrical energy to charge the one or more high-voltage capacitors to deliver two applications of the defibrillation signal to the patient without recharging the rechargeable battery from outside the one or more housings.

49. The implantable cardiac device of claim 42, wherein the energy management circuitry is configured to pull energy from the primary battery to power the rechargeable battery as needed.

50. The implantable cardiac device of claim 42, wherein:

the rechargeable battery is configured to supply power to at least the one or more cardiac sensors, the body orientation unit, and the alarm circuitry and

the primary battery is configured to power one or more high-voltage capacitors configured to deliver cardiac defibrillation therapy.

51. The implantable cardiac device of claim 50, wherein the rechargeable battery and the primary battery are configured to charge the one or more high-voltage capacitors.

52. The implantable cardiac device of claim 50, wherein the energy management circuitry is configured to pull energy from the primary battery to power the rechargeable battery as needed.

53. The implantable cardiac device of claim 42, wherein

the primary battery is configured to supply power to at least the one or more cardiac sensors and the body orientation unit, and

when the therapy circuitry is applying the defibrillation signal to the patient, the rechargeable battery is configured to continuously deliver power for applying the defibrillation signal to the patient, and

wherein the rechargeable battery is configured to be recharged from outside the one or more housings.

54. The implantable cardiac device of claim 53, wherein the alarm circuitry is configured to alert the patient of a need to seek attention to recharge the device.

55. The implantable cardiac device of claim 54, wherein the alarm circuitry is configured to provide alerts that are more severe as time elapses from when a first alert was initiated.

56. The implantable cardiac device of claim 54, wherein the alarm circuitry is configured to only emit an alert when the patient'"'"'s body is substantially vertical and stops emitting the alert when the patient'"'"'s body is substantially horizontal.

57. The implantable cardiac device of claim 54, wherein the alarm circuitry continues alerting unless the implantable cardiac device has a sufficient level of charge for normal operation.

58. The implantable cardiac device of claim 54, wherein the alarm circuitry is configured to transmit an alert via wireless communication to monitoring equipment outside the patient'"'"'s body.

59. The implantable cardiac device of claim 53, wherein the alarm circuitry is configured to alert at least one of the patient and a physician via wireless communication.

60. The implantable cardiac device of claim 42, wherein

the primary battery is large enough to last an entire life of the implantable cardiac device, and

the rechargeable battery has sufficient electrical energy to the charge one or more high-voltage capacitors to deliver two applications of the defibrillation signal to the patient without recharging the rechargeable battery from outside the one or more housings.

61. The implantable cardiac device of claim 60, wherein the rechargeable battery is configured to receive a standby charge from the primary battery, use the standby charge for a capacitor reformation process, and charge the one or more high-voltage capacitors for a first future application of a defibrillation signal to the patient.

62. The implantable cardiac device of claim 42, wherein the capacitor reformation circuitry is configured to (i) pull energy from the rechargeable battery to power a capacitor reformation process for one or more high-voltage capacitors, and (ii) after completing the capacitor reformation process, restore energy from the one or more high-voltage capacitors to the rechargeable battery.

63. The implantable cardiac device of claim 42, wherein the capacitor reformation circuitry is configured to use both the rechargeable battery and the primary battery to charge one or more high-voltage capacitors.

64. The implantable cardiac device of claim 63, wherein

the primary battery is configured to charge the rechargeable battery after the one or more high-voltage capacitors are charged for cardiac defibrillation therapy delivery, thereby allowing delivery of defibrillation shocks as the patient needs them.

65. The implantable cardiac device of claim 42, wherein the primary battery is configured to charge the rechargeable battery after one or more high-voltage capacitors are charged for cardiac defibrillation therapy delivery, thereby allowing delivery of defibrillation shocks as the patient needs them.

66. The implantable cardiac device of claim 33, wherein the body orientation unit comprises at least one of an accelerometer, gyrometer, inclinometer or any combination thereof.

67. The implantable cardiac device of claim 66, wherein the body orientation unit is configured to detect a horizontal position of at least a portion of the patient'"'"'s body.

68. The implantable cardiac device of claim 66, wherein the body orientation unit is configured to detect a vertical position of at least a portion of the patient'"'"'s body.

69. The implantable cardiac device of claim 33, wherein at least one of the one or more energy sources is a single, high-voltage battery comprising Barium Titanate chemistry and configured to power the implantable cardiac device and charge one or more high-voltage capacitors configured to deliver the cardiac defibrillation therapy.

70. The implantable cardiac device of claim 69, wherein the one or more high-voltage capacitors are external to the one or more housings.

71. The implantable cardiac device of claim 70, wherein the therapy circuitry is programmed to allow only a set amount of energy and power to be pulled from the single, high-voltage battery for delivery to the patient.

72. The implantable cardiac device of claim 33, wherein the one or more energy sources includes:

a first energy storage source configured to power at least the one or more cardiac sensors, the body orientation unit, and the alarm circuitry; and

a second, high-voltage battery including Barium Titanate chemistry capable of storing sufficient energy for one application of the defibrillation signal to the patient, and wherein the second high-voltage battery is configured to receive charge from the first energy storage source for each application of the defibrillation signal applied to the patient.

73. The implantable cardiac device of claim 33, wherein the one or energy source includes:

a first energy source configured to power at least the one or more cardiac sensors, the body orientation unit, and the alarm circuitry, and

a second, high-voltage, rechargeable battery, including Barium Titanate chemistry, configured to store energy and to output power for application of the defibrillation signal to the patient.

74. The implantable cardiac device of claim 33, wherein the implantable cardiac device is configured to determine whether the patient has experienced one of sudden cardiac death, cardiac arrest, or ventricular fibrillation, or any combination thereof, based at least in part on cardiac data from the one or more cardiac sensors and orientation data from the body orientation unit.

75. The implantable cardiac device of claim 33, wherein the implantable cardiac device is configured to deliver a defibrillation signal only when (i) cardiac data from the one or more cardiac sensors indicates that the patient has experienced at least one of sudden cardiac death, cardiac arrest, or ventricular fibrillation and (ii) orientation data from the body orientation unit indicates that the at least a portion of the patient'"'"'s body is in a substantially horizontal position.

76. The implantable cardiac device of claim 33, wherein the therapy circuitry is configured to terminate an attempt to apply cardiac therapy in response to determining that the at least a portion of the patient'"'"'s body being in an essentially vertical position.

77. The implantable cardiac device of claim 1, wherein the alarm circuitry is configured to alert the patient of an imminent application of a defibrillation signal via an audible alert.

78. The implantable cardiac device of claim 1, wherein the alarm circuitry is configured to alert the patient of an imminent application of a defibrillation signal via at least one of (i) an audible alert, (ii) vibration alert or (iii) a signal sent to an external computing device.

79. The implantable cardiac device of claim 33, wherein the body orientation unit is configured to detect trends and changes in physical activity of the patient.