Devices for detecting the presence of cardiac activity following administration of defibrillation therapy

• US 7,162,298 B2
• Filed: 09/10/2002
• Issued: 01/09/2007
• Est. Priority Date: 09/10/2002
• Status: Active Grant

• Current Assignee: UAB Research Foundation (University of Alabama System)
• Original Assignee: UAB Research Foundation (University of Alabama System)
• Inventors: Ideker, Raymond E., Walcott, Gregory P.
• Primary Examiner(s): Schaetzle; Kennedy
• Application Number:
  US10/238,340
• Publication Number:
  US 20040049117A1
• Time in Patent Office: 1,582 Days
• Field of Search: 607/4, 607/5, 607/6, 607/13, 607/9, 607/28, 607/14, 600/518, 600/509
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

The present invention provides systems, methods and computer program products for detecting the presence of cardiac activity in a patient. The present invention includes a detector circuit that is configured to detect the influence of a first defibrillation shock on the patient immediately subsequent to termination of a first defibrillation shock.

Claims

1. A device for detecting the presence of cardiac activity in a patient, comprising:

a detector circuit that is configured to detect the influence of a first defibrillation shock on the patient immediately subsequent to termination of a first defibrillation shock;

an isolation circuit configured to electrically isolate the detector circuit from the first defibrillation shock, wherein the detected cardiac activity comprises fibrillation and wherein the detector circuit is further configured to detect if the fibrillation ceases immediately after termination of the first defibrillation shock and reinitiates within a predetermined time period after the first defibrillation shock; and

a controller circuit wherein the controller circuit is configured to administer a second defibrillation shock having a second shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value immediately if it is determined that the fibrillation has ceased immediately after termination of the first defibrillation shock and reinitiated within the predetermined time period.

2. A device according to claim 1, wherein the detector circuit is further configured to detect the influence of the first defibrillation shock on the patient within about two seconds of termination of the first defibrillation shock.

3. A device according to claim 1, wherein the device further comprises a defibrillator circuit configured to administer the first defibrillation shock to the patient.

4. A device according to claim 3, wherein the device further comprises a recorder circuit configured to record the influence of the first defibrillation shock on the patient immediately subsequent to termination of the first defibrillation shock.

5. A device according to claim 4, wherein the recorder circuit is further configured to record the influence of the first defibrillation shock on the patient within about two seconds of termination of the first defibrillation shock.

6. A device according to claim 4, wherein the isolation circuit is further configured to electrically isolate the detector circuit from the defibrillation shock from about 0.3 seconds before initiation of the first defibrillation shock to about 0.3 seconds after termination of the first defibrillation shock.

7. A device according to claim 4, wherein the isolation circuit comprises at least one of a relay and a switch.

8. A device according to claim 4, wherein the defibrillator circuit comprises a plurality of electrodes and wherein the isolation circuit is further configured to decouple the plurality of electrodes of the defibrillator circuit from the detector circuit before initiation of the first defibrillation shock until after termination of the first defibrillation shock.

9. A device according to claim 4, wherein the isolation circuit is further configured to decouple the plurality of electrodes of the defibrillator circuit from the recorder circuit before initiation of the first defibrillation shock until after termination of the first defibrillation shock.

10. A device according to claim 4, wherein the detector circuit comprises at least one amplifier and wherein the isolation circuit is further configured to decouple the at least one amplifier from the defibrillation circuit.

11. A device according to claim 4, wherein the detector circuit comprises at least one amplifier and wherein the isolation circuit is further configured to decouple the at least one amplifier by isolating at least one sensor lead from the detector circuit.

12. A device according to claim 4, wherein the isolation circuit is further configured to pass a current through the detector circuit.

13. A device according to claim 4, wherein the detector circuit further comprises at least one amplifier configured to have a large dynamic range associated therewith.

14. A device according to claim 4, wherein the detector circuit, the defibrillator circuit, the recorder circuit and the isolation circuit are configured to be disposed within a single implantable housing for implantation in the patient.

15. A device according to claim 14, wherein the implantable housing is an implantable defibrillator.

16. A device according to claim 15, wherein the isolation circuit further comprises an insulator module that is configured to insulate the detector circuit within the implantable defibrillator from the first defibrillation shock.

17. A device according to claim 4, where the detector circuit, the defibrillator circuit, the recorder circuit and the isolation circuit are configured to be disposed within a single housing that is external to the patient.

18. A device according to claim 17, wherein the single housing is an external defibrillator.

19. A device according to claim 4, wherein the detector circuit, the defibrillator circuit, the recorder circuit and the isolation circuit are respective separate devices.

20. A device according to claim 19, wherein at least one of the detector circuit, the defibrillator circuit, the recorder circuit and the isolation circuit is configured to be disposed within an implantable housing for implantation within the patient and at least one of the detector circuit, the defibrillator circuit, the recorder circuit and the isolation circuit is configured to be external to the patient.

21. A device according to claim 4, wherein the defibrillator circuit is further configured to indicate termination of the defibrillation shock to the detector circuit.

22. A device according to claim 1, wherein the detector circuit is further configured to determine if the cardiac activity of the patient immediately subsequent to termination of a first defibrillation shock is normal cardiac activity.

23. A device according to claim 22, wherein the device further comprises a controller circuit configured to apply a pacing stimulation signal to a heart of a patient if the detector circuit determines that the cardiac activity of the patient immediately subsequent to termination of the first defibrillation shock is normal cardiac activity.

24. A device according to claim 23, wherein the controller circuit is further configured to apply the pacing stimulation within about two seconds of termination of the defibrillation shock.

25. A device according to claim 23, wherein the pacing stimulation signal comprises single pacing stimulation.

26. A device according to claim 25, wherein the controller circuit is further configured to detect cardiac activity of the heart associated with application of the single pacing stimulation and selectively apply paired pacing stimulation based on the detected cardiac activity.

27. A device according to claim 25, wherein the controller circuit is further configured to detect cardiac activity of the heart and selectively apply paired pacing stimulation based on the detected cardiac activity.

28. A device according to claim 23, wherein the pacing stimulation signal comprises paired pacing stimulation.

29. A device according to claim 23, wherein the controller circuit is further configured to detect a signal specifying application of paired pacing and selectively apply paired pacing stimulation based on the detected signal.

30. A device according to claim 23, wherein the defibrillation shock is applied to a heart of a patient using at least one first set of electrodes and wherein the controller circuit is further configured to apply the pacing stimulation signal to the heart of the patient subsequent to termination of the defibrillation shock using at least one second set of electrodes, wherein the first set of electrodes and the second set of electrodes are different sets of electrodes.

31. A device according to claim 23, wherein the defibrillation shock is applied to a heart of a patient using at least one first set of electrodes and wherein the controller circuit is further configured to apply the pacing stimulation signal to the heart of the patient subsequent to termination of the defibrillation shock using at least one second set of electrodes, wherein the first set of electrodes and the second set of electrodes are the same set of electrodes.

32. A device according to claim 23, wherein the controller circuit is further configured to selectively apply paired pacing stimulation to the heart based on at least one of receipt of an external specification and sensed variables associated with cardiac activity.

33. A device according to claim 32, wherein the sensed variables associated with cardiac activity comprise a pulse pressure below a predefined threshold.

34. A device according to claim 33, wherein the controller circuit is configured to be disposed within an implantable housing for implantation in the patient.

35. A device according to claim 32, wherein the external specification comprises instruction from a healthcare provider.

36. A device according to claim 23, wherein the controller circuit is configured to be external to the patient.

37. A device according to claim 23, further comprising at least one set of electrodes for application of the pacing stimulation signal to the heart of the patient.

38. A device according to claim 24, wherein the controller circuit is further configured to apply the pacing stimulation within about one second of termination of the defibrillation shock.

39. A device according to claim 1, further comprising a controller circuit wherein the controller circuit is configured to:

wait a second predetermined time period if it is determined that the fibrillation ceased immediately after termination of the first defibrillation shock and reinitiated within the first predetermined time period; and

determine if fibrillation ceases after termination of the second predetermined time period; and

administer a third defibrillation shock having a third shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value after the second predetermined time period if it is determined that the fibrillation has not ceased after termination of the second predetermined time period.

40. A device according to claim 1, further comprising a controller circuit wherein the controller circuit is configured to:

administer cardiopulmonary resuscitation (CPR) for a second predetermined time period if the fibrillation ceased immediately after termination of the first defibrillation shock and reinitiated within the first predetermined time period;

determine if the cardiac activity has been influenced by the administration of CPR; and

administer a third defibrillation shock having a third shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value after termination of the second predetermined time period if it is determined that the fibrillation activity has not been influenced by the administration of CPR during the second predetermined time period.

41. A device according to claim 1, further comprising a controller circuit wherein the controller circuit is configured to:

administer a second defibrillation shock having a second shock value that is higher than the first shock value at the second time if the fibrillation is not influenced by the first defibrillation shock immediately after termination of the first defibrillation shock.

42. A device according to claim 23:

wherein the controller circuit is further configured to detect cardiac activity and/or function of the heart, select a type of pacing stimulation to apply to the heart of the patient subsequent to termination of the defibrillation shock based on the detected cardiac activity and/or function and apply the selected type of pacing stimulation.

43. A device according to claim 42, wherein the controller circuit is further configured to detect the cardiac activity and/or function before applying a defibrillation shock to a heart of the patient.

44. A device according to claim 42, wherein the controller circuit is further configured to detect the cardiac activity and/or function after applying a defibrillation shock to a heart of the patient.

45. A device according to claim 42, wherein the selected type of pacing stimulation comprises single pacing stimulation.

46. A device according to claim 42, wherein the selected type of pacing stimulation comprises paired pacing stimulation.

47. A device according to claim 42, wherein the selected type of pacing stimulation comprises a combination of single pacing stimulation and paired pacing stimulation.

48. A device according to claim 23, wherein the controller circuit is further configured to inhibit application of the pacing stimulation if cardiac activity is detected.

49. A device according to claim 48, wherein the detected cardiac activity comprises a detected blood pressure.

50. A device according to claim 48, wherein the detected cardiac activity comprises spontaneous electrical activity.

51. A system for detecting the presence of cardiac activity in a patient, comprising:

a first set of electrodes for applying a first defibrillation shock to a heart of the patient;

means for detecting the influence of the first defibrillation shock on the patient immediately subsequent to termination of a first defibrillation shock;

means for electrically isolating the means for detecting from the means for administering, wherein the detected cardiac activity comprises fibrillation and wherein the means for detecting comprises means for detecting if the fibrillation ceases immediately after termination of the first defibrillation shock and reinitiates within a predetermined time period after the first defibrillation shock; and

means for administering a second defibrillation shock having a second shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value immediately if it is determined that the fibrillation has ceased after termination of the first defibrillation shock and reinitiated within the predetermined time period.

52. A system according to claim 51, wherein the means for detecting further comprises detecting the influence of the first defibrillation shock on the patient within about two seconds of termination of the first defibrillation shock.

53. A system according to claim 51, wherein the system further comprises means for administering the first defibrillation shock to the patient.

54. A system according to claim 53, wherein the system further comprises means for recording the influence of the first defibrillation shock on the patient immediately subsequent to termination of the first defibrillation shock.

55. A system according to claim 54, wherein the means for recording comprises means for recording the influence of the first defibrillation shock on the patient within about two seconds of termination of the first defibrillation shock.

56. A system according to claim 54, wherein the means for detecting further comprises means for determining if the cardiac activity of the patient immediately subsequent to termination of a first defibrillation shock is normal cardiac activity.

57. A system according to claim 54, wherein the system further comprises means for applying a pacing stimulation signal to a heart of a patient if the detector circuit determines that the cardiac activity of the patient immediately subsequent to termination of the first defibrillation shock is normal cardiac activity.

58. A system according to claim 57, wherein the means for applying pacing stimulation comprises means for applying the pacing stimulation within about two seconds of termination of the defibrillation shock.

59. A system according to claim 57, wherein the pacing stimulation signal comprises single pacing stimulation.

60. A system according to claim 59, wherein means for applying pacing stimulation comprises means for detecting cardiac activity of the heart associated with application of the single pacing stimulation and selectively apply paired pacing stimulation based on the detected cardiac activity.

61. A system according to claim 59, wherein the means for applying stimulation further comprises detecting cardiac activity of the heart and selectively applying paired pacing stimulation based on the detected cardiac activity.

62. A system according to claim 57, wherein the pacing stimulation signal comprises paired pacing stimulation.

63. A system according to claim 57, wherein the means for applying stimulation further comprises means for detecting a signal specifying application of paired pacing and selectively apply paired pacing stimulation based on the detected signal.

64. A system according to claim 57, wherein the defibrillation shock is applied to a heart of a patient using at least one first set of electrodes and wherein the means for applying further comprises means for applying the pacing stimulation signal to the heart of the patient subsequent to termination of the defibrillation shock using at least one second set of electrodes, wherein the first set of electrodes and the second set of electrodes are different sets of electrodes.

65. A system according to claim 57, wherein the defibrillation shock is applied to a heart of a patient using at least one first set of electrodes and wherein the means for applying further comprises means for applying the pacing stimulation signal to the heart of the patient subsequent to termination of the defibrillation shock using at least one second set of electrodes, wherein the first set of electrodes and the second set of electrodes are the same set of electrodes.

66. A system according to claim 57, wherein the means for applying further comprises means for selectively applying paired pacing stimulation to the heart based on at least one of receipt of an external specification and sensed variables associated with cardiac activity.

67. A system according to claim 57, wherein the sensed variables associated with cardiac activity comprise a pulse pressure below a predefined threshold.

68. A system according to claim 57, wherein the external specification comprises instruction from a healthcare provider.

69. A system according to claim 57, wherein the controller circuit is configured to be disposed within an implantable housing for implantation in the patient.

70. A system according to claim 57, wherein the system further comprises:

means for detecting cardiac activity and/or function of the heart; and

means for selecting a type of pacing stimulation to apply to the heart of the patient subsequent to termination of the defibrillation shock based on the detected cardiac activity and/or function, wherein the means for applying comprises means for applying the selected type of pacing.

71. A system according to claim 70, wherein the means for detecting further comprises means for detecting cardiac activity and/or function before administering a defibrillation shock to a heart of the patient.

72. A system according to claim 70, wherein the means for detecting further comprises means for detecting cardiac activity and/or function after administering a defibrillation shock to a heart of the patient.

73. A system according to claim 70, wherein the selected type of pacing stimulation comprises single pacing stimulation.

74. A system according to claim 70, wherein the selected type of pacing stimulation comprises paired pacing stimulation.

75. A system according to claim 70, wherein the selected type of pacing stimulation comprises a combination of single pacing stimulation and paired pacing stimulation.

76. A system according to claim 57, wherein the means for applying further comprises means for inhibiting application of the pacing stimulation if cardiac activity is detected.

77. A system according to claim 76, wherein the detected cardiac activity comprises a detected blood pressure.

78. A system according to claim 76, wherein the detected cardiac activity comprises spontaneous electrical activity.

79. A system according to claim 51, further comprising:

means for waiting a second predetermined time period if it is determined that the fibrillation ceased after termination of the first defibrillation shock and reinitiated within the first predetermined time period; and

means for determining if fibrillation ceases after termination of the second predetermined time period; and

means for administering a third defibrillation shock having a third shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value after the second predetermined time period if it is determined that the fibrillation has not ceased after termination of the second predetermined time period.

80. A system according to claim 51, further comprising:

means for administering cardiopulmonary resuscitation (CPR) for a second predetermined time period if the fibrillation ceased after termination of the first defibrillation shock and reinitiated within the first predetermined time period;

means for determining if the cardiac activity has been influenced by the administration of CPR; and

means for administering a third defibrillation shock having a third shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value after termination of the second predetermined time period if it is determined that the fibrillation activity has not been influenced by the administration of CPR during the second predetermined time period.

81. A system according to claim 51, further comprising:

means for administering a second defibrillation shock having a second shock value that is higher than the first shock value at the second time if the fibrillation is not influenced by the first defibrillation shock immediately after termination of the first defibrillation shock.

82. A system for detecting the presence of cardiac activity in a patient, comprising:

a defibrillator circuit configured to administer the first defibrillation shock to the patient;

a detector circuit configured to detect the influence of the first defibrillation shock on the patient subsequent to termination of a first defibrillation shock; and

an isolation circuit configured to electrically isolate the detector circuit from the defibrillator circuit, wherein the detected cardiac activity comprises fibrillation and wherein the detector circuit is further configured to detect if the fibrillation ceases immediately after termination of the first defibrillation shock and reinitiates within a predetermined time period after the first defibrillation shock and wherein the defibrillator circuit is further configured to administer a second defibrillation shock having a second shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value immediately if it is determined that the fibrillation has ceased after termination of the first defibrillation shock and reinitiated within the predetermined time period.

83. A computer program product for detecting the presence of cardiac activity in a patient, comprising:

computer readable medium having computer readable program code embodied therein, the computer readable program code comprising;

computer readable program code for detecting the influence of the first defibrillation shock on the patient immediately subsequent to termination of a first defibrillation shock; and

computer readable program code for electrically isolating the means for detecting from the means for administering, wherein the detected cardiac activity comprises fibrillation and wherein the computer readable program code for detecting comprises computer readable program code for detecting if the fibrillation ceases immediately after termination of the first defibrillation shock and reinitiates within a predetermined time period after the first defibrillation shock; and

computer readable program code for administering a second defibrillation shock having a second shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value immediately if it is determined that the fibrillation has ceased after termination of the first defibrillation shock and reinitiated within the predetermined time period.

84. A computer program product according to claim 83, wherein the computer readable program code for detecting further comprises computer readable program code for detecting the influence of the first defibrillation shock on the patient within about two seconds of termination of the first defibrillation shock.

85. A computer program product according to claim 83, wherein the computer program product further comprises computer readable program code for administering the first defibrillation shock to the patient.

86. A computer program product according to claim 85, wherein the computer program product further comprises computer readable program code for recording the influence of the first defibrillation shock on the patient immediately subsequent to termination of the first defibrillation shock.

87. A computer program product according to claim 86, wherein the computer readable program code for recording comprises computer readable program code for recording the influence of the first defibrillation shock on the patient within about two seconds of termination of the first defibrillation shock.

88. A computer program product according to claim 83, wherein the computer readable program code for detecting further comprises computer readable program code for determining if the cardiac activity of the patient immediately subsequent to termination of a first defibrillation shock is normal cardiac activity.

89. A computer program product according to claim 88, wherein the computer program product further comprises:

computer readable program code for applying a pacing stimulation signal to a heart of a patient it is determined that the cardiac activity of the patient immediately subsequent to termination of the first defibrillation shock is normal cardiac activity.

90. A computer program product of claim 89, wherein the computer readable program code for applying pacing stimulation further comprises computer readable program code for applying the pacing stimulation within about two seconds of termination of the defibrillation shock.

91. A computer program product of claim 90, wherein the computer readable program code that applies the defibrillation shock further comprises computer readable program code that applies to a heart of a patient using at least one first set of electrodes and wherein the computer readable program code that applies pacing stimulation further comprises computer readable program code that applies the pacing stimulation signal to the heart of the patient subsequent to termination of the defibrillation shock using at least one second set of electrodes, wherein the first set of electrodes and the second set of electrodes are the same set of electrodes.

92. A computer program product of claim 89, wherein the pacing stimulation signal comprises single pacing stimulation.

93. A computer program product of claim 89, wherein the pacing stimulation signal comprises paired pacing stimulation.

94. A computer program product of claim 93, wherein the computer readable program code that applies pacing stimulation further comprises computer readable program code that detects cardiac activity of the heart associated with application of the single pacing stimulation and selectively applies paired pacing stimulation based on the detected cardiac activity.

95. A computer program product of claim 94, wherein the computer readable program code that applies further comprises computer readable program code that detects cardiac activity of the heart and selectively applies paired pacing stimulation based on the detected cardiac activity.

96. A computer program product of claim 89, wherein the computer readable program code that applies further comprises computer readable program code that detects a signal specifying application of paired pacing and selectively applies paired pacing stimulation based on the detected signal.

97. A computer program product of claim 96, wherein the defibrillation shock is applied to a heart of a patient using at least one first set of electrodes and wherein the computer readable program code that applies the pacing stimulation further comprises computer readable program code that applies the pacing stimulation signal to the heart of the patient subsequent to termination of the defibrillation shock using at least one second set of electrodes, wherein the first set of electrodes and the second set of electrodes are different sets of electrodes.

98. A computer program product of claim 89, wherein the computer readable program code that applies further comprises computer readable program code that selectively applies paired pacing stimulation to the heart based on at least one of receipt of an external specification and sensed variables associated with cardiac activity.

99. A computer program product of claim 98, wherein the sensed variables associated with cardiac activity comprise a pulse pressure below a predefined threshold.

100. A computer program product of claim 98, wherein the external specification comprises instruction from a healthcare provider.

101. A computer program product according to claim 89, wherein the computer readable program code that applies a pacing stimulation further comprises:

computer readable program code that detects cardiac activity and/or function in the heart;

computer readable program code that selects a type of pacing stimulation to apply to the heart of the patient subsequent to termination of the defibrillation shock based on the detected cardiac activity and/or function; and

computer readable program code that applies the selected type of pacing.

102. A computer program product according to claim 101, wherein the computer readable program code that detects cardiac activity and/or function comprises computer readable program code that detects the cardiac activity and/or function before applying a defibrillation shock to a heart of the patient.

103. A computer program product according to claim 101, wherein the computer readable program code that detects cardiac activity and/or function comprises computer readable program code that detects the cardiac activity and/or function after applying a defibrillation shock to a heart of the patient.

104. A computer program product according to claim 101, wherein the selected type of pacing stimulation comprises single pacing stimulation.

105. A computer program product according to claim 101, wherein the selected type of pacing stimulation comprises paired pacing stimulation.

106. A computer program product according to claim 101, wherein the selected type of pacing stimulation comprises a combination of single pacing stimulation and paired pacing stimulation.

107. A computer program product according to claim 89, wherein the computer program code that applies the pacing stimulation further comprises computer readable program code that inhibits application of the pacing stimulation if cardiac activity is detected.

108. A computer program product according to claim 107, wherein the detected cardiac activity comprises a detected blood pressure.

109. A computer program product according to claim 107, wherein the detected cardiac activity comprises spontaneous electrical activity.

110. A computer program product of claim 83, further comprising:

computer readable program code that waits a second predetermined time period if it is determined that the fibrillation ceased after termination of the first defibrillation shock and reinitiated within the first predetermined time period; and

computer readable program code that determines if fibrillation ceases after termination of the second predetermined time period; and

computer readable program code that administers a third defibrillation shock having a third shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value after the second predetermined time period if it is determined that the fibrillation has not ceased after termination of the second predetermined time period.

111. A computer program product according to claim 83, further comprising:

computer readable program code that administers cardiopulmonary resuscitation (CPR) for a second predetermined time period if the fibrillation ceased after termination of the first defibrillation shock and reinitiated within the first predetermined time period;

computer readable program code that determines if the cardiac activity has been influenced by the administration of CPR; and

computer readable program code that administers a third defibrillation shock having a third shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value after termination of the second predetermined time period if it is determined that the fibrillation activity has not been influenced by the administration of CPR during the second predetermined time period.

112. A computer program product according to claim 83, further comprising:

computer readable program code that administers a second defibrillation shock having a second shock value that is higher than the first shock value at the second time if the fibrillation is not influenced by the first defibrillation shock immediately after termination of the first defibrillation shock.

113. A method for detecting the presence of cardiac activity in a patient, comprising:

applying a first defibrillation shock to a heart of the patient; and

detecting the influence of the first defibrillation shock on the patient immediately subsequent to termination of a first defibrillation shock; and

electrically isolating the detector circuit from the first defibrillation shock, wherein the detected cardiac activity comprises fibrillation and wherein the detector circuit is further configured to detect if the fibrillation ceases immediately after termination of the first defibrillation shock and reinitiates within a predetermined time period after the first defibrillation shock; and

applying a second defibrillation shock to the heart of the patient having a second shock value that is at least one of substantially equivalent to the first shock value and less than the first shock value immediately if it is determined that the fibrillation has ceased immediately after termination of the first defibrillation shock and reinitiated within the predetermined time period.