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Method for improving cardiac function following delivery of a defibrillation shock Number:6,760,621 from the United States Patent and Trademark Office (PTO) owispatent

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Title: Method for improving cardiac function following delivery of a defibrillation shock

Abstract: A method of reducing the likelihood of pulseless electrical activity (PEA) after defibrillation in a subject comprises administering to a subject afflicted with fibrillation a first treatment waveform, the first treatment waveform insufficient to defibrillate the heart; and then administering to the subject a second treatment waveform that defibrillates the heart and restores organized electrical activity in the heart. The first treatment waveform reduces the likelihood of onset of PEA following the second treatment waveform, as compared to that likelihood which would be present in the absence of the first treatment waveform.

Patent Number: 6,760,621 Issued on 07/06/2004 to Walcott,   et al.


Inventors: Walcott; Gregory P. (Wilsonville, AL), Chapman; Fred William (Newcastle, WA), Ideker; Raymond E. (Birmingham, AL)
Assignee: UAB Research Foundation (Birmingham, AL)
Appl. No.: 10/012,115
Filed: November 13, 2001


Related U.S. Patent Documents

Application NumberFiling DatePatent NumberIssue Date
772225Jan., 20016556856

Current U.S. Class: 607/6
Current International Class: A61N 1/39 (20060101)
Field of Search: 607/4-8,14


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Primary Examiner: Getzow; Scott M.
Attorney, Agent or Firm: Myers Bigel Sibley & Sajovec

Parent Case Text



RELATED APPLICATIONS

This application is a continuation-in-part of commonly owned, U.S. patent application Ser. No. 09/772,225, filed Jan. 29, 2001, now U.S. Pat. No. 6,556,856 the disclosure of which is incorporated by reference herein in its entirety.
Claims



We claim:

1. A method of reducing the likelihood of onset of pulseless electrical activity after defibrillation in a subject afflicted with a fibrillating heart, said method comprising the steps of: administering to a subject afflicted with fibrillation a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart; and then administering to said subject a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart; with said first treatment waveform reducing the likelihood of onset of pulseless electrical activity following said second treatment waveform as compared to that likelihood which would be present in the absence of said first treatment waveform.

2. A method according to claim 1, wherein said fibrillation is ventricular fibrillation.

3. A method according to claim 1, wherein said first treatment waveform comprises a single electrical pulse.

4. A method according to claim 1, wherein said first treatment waveform comprises a series of electrical pulses.

5. A method according to claim 1, wherein said first treatment waveform is insufficient to reduce the defibrillation threshold of said subject.

6. A method according to claim 1, wherein said second treatment waveform comprises a single electrical pulse.

7. A method according to claim 1, wherein said second treatment waveform comprises a series of electrical pulses.

8. A method according to claim 1, wherein said first treatment waveform is administered by external electrodes and has an energy of from about 1 to 400 Joules.

9. A method according to claim 1, wherein said first treatment waveform is administered by internal electrodes and has an energy of from about 0.1 to 50 Joules.

10. A method according to claim 1, wherein said first treatment waveform and said second treatment waveform are sequential.

11. A method according to claim 1, wherein said second treatment waveform immediately follows said first treatment waveform.

12. A method according to claim 1, wherein said second treatment waveform follows said first treatment waveform by from 1 millisecond to 10 seconds.

13. A method according to claim 1, wherein said first treatment waveform and said second treatment waveform are at least partially interleaved.

14. A method according to claim 1, wherein said first treatment waveform is delivered through the same set of electrodes as said second treatment waveform.

15. A method according to claim 1, wherein said first treatment waveform is delivered through a different set of electrodes as said second treatment waveform.

16. A method according to claim 1, wherein said first treatment waveform is delivered by at least one cutaneous electrode.

17. A method according to claim 1, wherein said first treatment waveform is delivered by at least one subcutaneous electrode.

18. A method according to claim 1, wherein said first treatment waveform is delivered by at least one epicardial electrode.

19. A method according to claim 1, wherein said first treatment waveform is delivered by at least one transveneous electrode.

20. A method according to claim 1, wherein said first treatment waveform is delivered by at least one transveneous coronary sinus electrode positioned in the coronary sinus or a cardiac vein.

21. A system for the defibrillation of the heart of a patient in need of such treatment, which system provides reduced likelihood of onset of pulseless electrical activity after defibrillation in a subject afflicted with a fibrillating heart, said system comprising: a power supply; and a controller operatively associated with said power supply, said controller configured for delivering a defibrillation sequence comprising a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart; and then a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart; with said first treatment waveform reducing the likelihood of onset of pulseless electrical activity following said second treatment waveform as compared to that likelihood which would be present in the absence of said first treatment waveform.

22. A system according to claim 21, wherein said fibrillation is ventricular fibrillation.

23. A system method according to claim 21, wherein said first treatment waveform comprises a single electrical pulse.

24. A system according to claim 21, wherein said first treatment waveform comprises a series of electrical pulses.

25. A system according to claim 21, wherein said first treatment waveform is insufficient to reduce the defibrillation threshold of said subject.

26. A system according to claim 21, wherein said second treatment waveform comprises a single electrical pulse.

27. A system according to claim 21, wherein said second treatment waveform comprises a series of electrical pulses.

28. A system according to claim 21, further comprising: a plurality of external electrodes operatively associated with said controller, and wherein said first treatment waveform is administered by external electrodes and has an energy of from about 1 to 400 Joules.

29. A system according to claim 21, further comprising: a plurality of internal electrodes operatively associated with said controller; and wherein said first treatment waveform is administered by internal electrodes and has an energy of from about 0.1 to 50 Joules.

30. A system according to claim 21, wherein said controller is configured so that said first treatment waveform and said second treatment waveform are sequential.

31. A system according to claim 21, wherein said controller is configured so that said second treatment waveform immediately follows said first treatment waveform.

32. A system according to claim 21, wherein said controller is configured so that said second treatment waveform follows said first treatment waveform by from 1 millisecond to 10 seconds.

33. A system according to claim 21, wherein said controller is configured so that said first treatment waveform and said second treatment waveform are at least partially interleaved.

34. A system according to claim 21, wherein said controller is configured so that said first treatment waveform is delivered through the same set of electrodes as said second treatment waveform.

35. A system according to claim 21, wherein said controller is configured so that said first treatment waveform is delivered through a different set of electrodes as said second treatment waveform.

36. A system according to claim 21, further comprising at least one cutaneous electrode operatively associated with said controller, and wherein said controller is configured so that said first treatment waveform is delivered by said at least one cutaneous electrode.

37. A system according to claim 21, further comprising at least one subcutaneous electrode operatively associated with said controller, and wherein said first treatment waveform is delivered by said at least one subcutaneous electrode.

38. A system according to claim 21, futher comprising at least one epicardial electrode operatively associated with said controller, and wherein said first treatment waveform is delivered by at least one epicardial electrode.

39. system according to claim 21, further comprising at least one transveneous electrode operatively associated with said controller, and wherein said first treatment waveform is delivered by said at least one transveneous electrode.

40. A system according to claim 21, further comprising at least one transveneous coronary sinus electrode operatively associated with said controller, and wherein said first treatment waveform is delivered by said at least one transveneous coronary sinus electrode.

41. A method for the external defibrillation of the heart of a patient afflicted with ventricular fibrillation, comprising the steps of: externally administering to said patient a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart; and then externally administering to said subject a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart; wherein said first treatment waveform has an energy of from about 1 to about 400 Joules.

42. A method according to claim 41, wherein: said first treatment waveform is administered for a time of 0.05 to 10 seconds; and said second treatment waveform is administered within 5 seconds of said first treatment waveform.

43. A method according to claim 41, further comprising the steps of: optionally generating a warning signal prior to said first treatment waveform; then generating a warning signal during said first treatment waveform, and then optionally generating a warning signal during said second treatment waveform.

44. A method according to claim 43, wherein said warning signal comprises an auditory, visual, or tactile signal.

45. A method according to claim 43, wherein said step of externally administering to said patient a first treatment waveform is preceded by the step of: determining the presence or absence of a likelihood of pulseless electrical activity following defibrillation, and wherein: said step of administering said first treatment waveform is carried out if a likelihood of pulseless electrical activity following defibrillation is determined, and said step of administering said first treatment waveform is eliminated if a likelihood of pulseless electrical activity following defibrillation is not determined.

46. A method according to claim 41, wherein said second treatment waveform has an energy of from about 100 to 400 Joules.

47. A method according to claim 41, wherein said first treatment waveform and said second treatment waveform are sequential.

48. A method according to claim 41, wherein said second treatment waveform immediately follows said first treatment waveform.

49. A method according to claim 41, wherein said first treatment waveform and said second treatment waveform are at least partially interleaved.

50. An external defibrillation system for the external defibrillation of the heart of a patient afflicted with ventricular fibrillation, comprising: a power supply; and a controller operatively associated with said power supply, said controller configured for delivering a defibrillation sequence comprising a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart and having an energy from about 1 to 400 Joules; and then a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart.

51. A system according to claim 50, said controller configured so that said first treatment waveform is administered for a time of 0.05 to 10 seconds; and said second treatment waveform is administered within 5 seconds of said first treatment waveform.

52. A system according to claim 50, further comprising a warning signal generator operatively associated with said controller, and with said controller configured to: optionally generating a warning signal prior to said first treatment waveform; then generating a warning signal during said first treatment waveform, and then optionally generating a warning signal during said second treatment waveform.

53. A system according to claim 52, wherein said warning signal generator is an auditory, visual, or tactile signal generator.

54. A system according to claim 52, further comprising means for determining the likelihood of pulseless electrical activity following defibrillation configured so that said step of administering said first treatment waveform is carried out if a likelihood of pulseless electrical activity following defibrillation is determined, and said step of administering said first treatment waveform is eliminated if a likelihood of pulseless electrical activity following defibrillation is not determined.

55. A system according to claim 50, wherein said controller is configured so that said second treatment waveform has an energy of from about 100 to 400 Joules.

56. A system according to claim 50, wherein said controller is configured so that said first treatment waveform and said second treatment waveform are sequential.

57. A system according to claim 50, wherein said controller is configured so that said second treatment waveform immediately follows said first treatment waveform.

58. A system according to claim 50, wherein said controller is configured so that said first treatment waveform and said second treatment waveform are at least partially interleaved.

59. A method of reducing the likelihood of onset of pulseless electrical activity after defibrillation with an implantable defibrillator in a subject afflicted with a fibrillating heart, said method comprising the steps of: administering to a subject afflicted with fibrillation a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart; and then administering to said subject a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart; with said first treatment waveform reducing the likelihood of onset of pulseless electrical activity following said second treatment waveform as compared to that likelihood which would be present in the absence of said first treatment waveform.

60. A method according to claim 59, wherein at least one of said first and second treatment waveforms is delivered by an electrode positioned in the coronary sinus, in a vein on the surface of the left ventricle, or in a vein at the junction of the right and left ventricles.

61. A method according to claim 59, wherein at least one of said first and second treatment waveforms is delivered by an electrode positioned on an external surface portion of said implantable defibrillator.

62. A method according to claim 59, wherein said first treatment waveform is delivered between at least a first electrode and second electrode; said first electrode selected from the group consisting of right ventricle, superior vena cava, and right atrium electrodes; and said second electrode selected from the group consisting of thoracic, superior vena cava, left ventricle, coronary sinus, left ventricle vein electrodes and left and right ventricle junction vein electrodes.

63. A method according to claim 59, wherein said second treatment waveform is delivered between at least a first electrode and second electrode; said first electrode selected from the group consisting of right ventricle, superior vena cava, and right atrium electrodes; and said second electrode selected from the group consisting of thoracic, superior vena cava, left ventricle, coronary sinus, left ventricle vein electrodes, and left and right ventricle junction electrodes.

64. A method according to claim 59, wherein said first treatment waveform has an energy of from about 0.1 to 50 Joules.

65. A method according to claim 59, wherein said second treatment waveform has an energy of from about 1 to 50 Joules.

66. A method according to claim 59, wherein said first treatment waveform and said second treatment waveform are sequential.

67. A method according to claim 59, wherein said second treatment waveform immediately follows said first treatment waveform.

68. A method according to claim 59, wherein said first treatment waveform and said second treatment waveform are at least partially interleaved.

69. An implantable defibrillator for defibrillating the heart of a subject in need therof, comprising: a power supply; and a controller operatively associated with said power supply, said controller configured for delivering a defibrillation sequence comprising a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart; and then a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart; with said first treatment waveform reducing the likelihood of onset of pulseless electrical activity following said second treatment waveform as compared to that likelihood which would be present in the absence of said first treatment waveform.

70. A system according to claim 69, further comprising an electrode configured for positioning in the coronary sinus or in a vein on the surface of the left ventricle of said heart, wherein at least one of said first and second treatment waveforms is delivered by said electrode.

71. A system according to claim 69, further comprising an electrode positioned on an external surface portion of said implantable defibrillator, wherein at least one of said first and second treatment waveforms is delivered by said electrode.

72. A system according to claim 69, further comprising at least a first electrode and a second electrode, and wherein said controller is configured so that said first treatment waveform is delivered between said first electrode and second electrode; said first electrode selected from the group consisting of right ventricle, superior vena cava, and right atrium electrodes; and said second electrode selected from the group consisting of thoracic, superior vena cava, left ventricle, coronary sinus, left ventricle vein electrodes, and left and right ventricle junction vein electrodes.

73. A system according to claim 69, further comprising at least a first electrode and a second electrode, and wherein said controller is configured so that said second treatment waveform is delivered between said first electrode and second electrode; said first electrode selected from the group consisting of right ventricle, superior vena cava, and right atrium electrodes; and said second electrode selected from the group consisting of thoracic, superior vena cava, left ventricle, coronary sinus, left ventricle vein electrodes, and left and right ventricle junction vein electrodes.

74. A system according to claim 69, said controller configured so that said first treatment waveform has an energy of from about 0.1 to 50 Joules.

75. A system according to claim 69, said controller configured so that said second treatment waveform has an energy of from about 1 to 50 Joules.

76. A system according to claim 69, said controller configured so that said first treatment waveform and said second treatment waveform are sequential.

77. A system according to claim 69, said controller configured so that said second treatment waveform immediately follows said first treatment waveform.

78. A system according to claim 69, said controller configured so that said first treatment waveform and said second treatment waveform are at least partially interleaved.

79. A defibrillation system for the defibrillation of the heart of a patient afflicted with ventricular fibrillation, comprising: a detector for detecting electrical activity from the heart of said patient during ventricular fibrillation; a power supply; a signal analyzer for determining the likelihood of pulseless electrical activity in said patient after delivery of a defibrillation treatment waveform to said patient; and a controller operatively associated with said detector, said power supply and said signal analyzer, said controller configured for delivering a defibrillation sequence, said defibrillation sequence optionally comprising a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart, and then delivering a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart; and wherein said first treatment waveform is delivered when a high likelihood of pulseless electrical activity after defibrillation is determined, and said first treatment waveform is not delivered when a low likelihood of pulseless electrical activity after defibrillation is determined.

80. A system according to claim 79, said controller configured so that said first treatment waveform is administered for a time of 0.05 to 10 seconds; and said second treatment waveform is administered within 5 seconds of said first treatment waveform.

81. A system according to claim 79, further comprising a user interface operatively associated with said controller, and with said controller confignred to: optionally generating a warning signal prior to said first treatment waveform; then generating a warning signal during said first treatment waveform, and then optionally generating a warning signal during said second treatment waveform.

82. A system according to claim 81, wherein said warning signal is an auditory, visual, or tactile signal.

83. A system according to claim 81, wherein said defibrillator is an external defibrillator.

84. A system according to claim 79, wherein said controller is configured so that said first treatment waveform has an energy of from about 1 to 400 Joules.

85. A system according to claim 79, wherein said controller is configured so that said second treatment waveform has an energy of from about 100 to 400 Joules.

86. A system according to claim 79, wherein said controller is configured so that said first treatment waveform and said second treatment waveform are sequential.

87. A system according to claim 79, wherein said controller is configured so that said second treatment waveform immediately follows said first treatment waveform.

88. A system according to claim 79, wherein said controller is configured so that said first treatment waveform and said second treatment waveform are at least partially interleaved.

89. A system according to claim 79, wherein said signal analyzer determines the likelihood of pulseless electrical activity by determining a viability index associated with the viability of the heart.

90. A system according to claim 89, wherein said first treatment waveform is delivered when the viability index indicates a high likelihood of pulseless electrical activity.

91. A system according to claim 90, wherein the viability index is determined based on the duration for which the patient is in ventricular fibrillation.

92. A system according to claim 90, wherein the viability index is determined based on an analysis of the patient waveform during ventricular fibrillation.

93. A system according to claim 92, wherein the analysis of the patient waveform produces a power spectrum of the patient waveform.

94. A system according to claim 92, wherein the analysis of the patient waveform produces a scaling structure of the patient waveform.

95. A system according to claim 92, wherein the analysis of the patient waveform produces an amplitude and frequency of the patient waveform.

96. A system according to claim 92, wherein the analysis of the patient waveform produces a median frequency of the patient waveform.

97. A system according to claim 92, wherein the analysis of the patient waveform produces a centroid frequency of the patient waveform.

98. A system according to claim 92, wherein the analysis of the patient waveform produces a combination of at least two of a power spectrum, a scaling structure, an amplitude and frequency, a median frequency and a centroid frequency of the patient waveform.

99. A system according to claim 90, wherein the viability index is determined based on cardiac motion of the patient's heart.

100. A system according to claim 90, wherein the viability index is determined based on user input.

101. A system according to claim 90, wherein the viability index is determined based on physiological measurements indicative of blood flow.

102. A system according to claim 101, wherein the physiological measurements are electrical measurements.

103. A system according to claim 101, wherein the physiological measurements are physical measurements.

104. A system according to claim 101, wherein the physiological measurements are chemical measurements.

105. A system according to claim 101, wherein the physiological measurements are a combination of at least two of electrical measurements, physical measurements are chemical measurements.

106. A system for defibrillation of the heart of a patient afflicted with ventricular fibrillation, comprising: a detector for detecting electrical activity from the heart of said patient during ventricular fibrillation; a power supply; a controller operatively associated with said detector and said power supply, said controller configured for delivering a defibrillation sequence, said defibrillation sequence optionally comprising a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart, and then delivering a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart; and wherein said first treatment waveform is delivered when a high likelihood of pulseless electrical activity after defibrillation is determined, and said first treatment waveform is not delivered when a low likelihood of pulseless electrical activity after defibrillation is determined.

107. A system according to claim 106, wherein the likelihood of pulseless electrical activity is determined manually after delivery of a defibrillation treatment waveform to said patient.

108. A system according to claim 106, wherein the likelihood of pulseless electrical activity is determined automatically after delivery of a defibrillation treatment waveform to said patient by a signal analyzer operatively associated with said controller.

109. A system according to claim 108, wherein the signal analyzer determines the likelihood of pulseless electrical activity by determining a viability index associated with the viability of the heart.

110. A system according to claim 109, wherein said first treatment waveform delivered if the viability index indicates that the viability of the heart is insufficient.

111. A system according to claim 110,wherein the viability index is determined based on the duration for which the patient is in ventricular fibrillation.

112. A system according to claim 110, wherein the viability index is determined based on an analysis of the patient waveform during ventricular fibrillation.

113. A system according to claim 112, wherein the analysis of the patient waveform produces a power spectrum of the patient waveform.

114. A system according to claim 112, wherein the analysis of the patient waveform produces a scaling structure of the patient waveform.

115. A system according to claim 112, wherein the analysis of the patient waveform produces an amplitude and frequency of the patient waveform.

116. A system according to claim 112, wherein the analysis of the patient waveform produces a median frequency of the patient waveform.

117. A system according to claim 112, wherein the analysis of the patient waveform produces a centroid frequency of the patient waveform.

118. A system according to claim 112, wherein the analysis of the patient waveform produces a combination of at least two of a power spectrum, a scaling structure, an amplitude and frequency, a median frequency and a centroid frequency of the patient waveform.

119. A system according to claim 110, wherein the viability index is determined based on cardiac motion of the patient's heart.

120. A system according to claim 110, wherein the viability index is determined based on user input.

121. A system according to claim 110, wherein the viability index is determined based on a physiological measurement indicative of blood flow.

122. A system according to claim 111, wherein the physiological measurement is an electrical measurement.

123. A system according to claim 111, wherein the physiological measurement is a physical measurement.

124. A system according to claim 111, wherein the physiological measurement is a chemical measurement.

125. A system according to claim 111, wherein the physiological measurement is a combination of at least two of an electrial measurement, physical measurement and chemical measurement.

126. A system according to claim 110, further comprising a user interface operatively associated with said controller, said user interface configured for reporting an indicia of the viability index to an operator so that the operator may optionally determine based on the viability index whether the first treatment waveform is to be delivered to the patient.

127. A system according to claim 110, wherein said first treatment waveform delivered to the patient is adjusted based on the viability index.

128. A method for the external defibrillation of the heart of a patient afflicted with ventricular fibrillation, comprising the steps of: externally administering to said patient a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart; and externally administering to said subject a second treatment waveform that defibrillates said heart and restores organized electrical activity to said heart; wherein said first treatment waveform is administered when a high likelihood of pulseless electrical activity after defibrillation is determined, and said first treatment waveform is not administered when a low likelihood of pulseless electrical activity after defibrillation is determined.

129. A method according to claim 128, wherein the likelihood of pulseless electrical activity is determined manually after delivery of a defibrillation treatment waveform to said patient.

130. A method according to claim 128, wherein the likelihood of pulseless electrical activity is determined automatically after delivery of a defibrillation treatment waveform to said patient.

131. A method according to claim 130, wherein the likelihood of pulseless electrical activity is represented as a viability index associated with the viability of the heart, and wherein said first treatment waveform is delivered if the viability index indicates a high likelihood of pulseless electrical activity.

132. A method according to claim 131, wherein the viability index is determined based on the duration for which the patient is in ventricular fibrillation.

133. A method according to claim 131, wherein the viability index is determined based on an analysis of the patient waveform during ventricular fibrillation.

134. A method according to claim 133, wherein the analysis of the patient waveform produces a power spectrum of the patient waveform.

135. A method according to claim 133, wherein the analysis of the patient waveform produces a scaling structure of the patient waveform.

136. A method according to claim 133, wherein the analysis of the patient waveform produces an amplitude and frequency of the patient waveform.

137. A method according to claim 133, wherein the analysis of the patient waveform produces a median frequency of the patient waveform.

138. A method according to claim 133, wherein the analysis of the patient waveform produces a centroid frequency of the patient waveform.

139. A method according to claim 133, wherein the analysis of the patient waveform produces a combination of at least two of a power spectrum, a scaling structure, an amplitude and frequency, a median frequency and a centroid frequency of the patient waveform.

140. A method according to claim 131, wherein the viability index is determined based on cardiac motion of the patient's heart.

141. A method according to claim 131, wherein the viability index is determined based on user input.

142. A method according to claim 131, wherein the viability index is determined based on a physiological measurement indicative of blood flow.

143. A method according to claim 142, wherein the physiological measurement is an electrical measurement.

144. A method according to claim 142, wherein the physiological measurement is a physical measurement.

145. A method according to claim 142, wherein the physiological measurement is a chemical measurement.

146. A method according to claim 142, wherein the physiological measurement is a combination of at least two of an electrical measurement, physical measurement and chemical measurement.

147. A method according to claim 131, further comprising reporting an indicia of the viability index to an operator so that the operator may optionally determine based on the viability index whether the first treatment waveform is to be administered to the patient.

148. A method according to claim 131, said first treatment waveform delivered to the patient is adjusted based on the viability index.
Description



FIELD OF THE INVENTION

The present invention concerns methods for improving cardiac function and reducing the occurrence of pulseless electrical activity after the delivery of a defibrillation pulse to a subject.

BACKGROUND OF THE INVENTION

Sudden cardiac death (SCD) accounts for an estimated 200,000 to 400,000 deaths annually in the United States alone. The initial cardiac rhythm in the majority of SCD cases is ventricular fibrillation (VF). Only approximately 10% of all SCD victims will be discharged from the hospital despite prompt CPR, a good emergency medical system response time, and use of automatic external defibrillators.

Approximately 50% of SCD patients will be treated with a defibrillator, by which they are administered a defibrillation waveform. Of the "successful" defibrillations, approximately 50% will exhibit an electrical pulse as demonstrated by an electrocardiogram, but will not exhibit a physical pulse as demonstrated by restored, peripherally measured, blood pressure. This condition is known as "pulseless electrical activity" (PEA) or "electromechanical dissociation" (EMD). Only approximately 8% of individuals with post-shock PEA survive to be discharged from the hospital. Hence, there is a clear need for ways to reduce the frequency or likelihood of onset of PEA to thereby increase the efficacy of defibrillation.

PCT Application WO 00/66222 to Rosborough and Deno describes a method and apparatus for treatment of cardiac electromechanical dissociation in which a first treatment signal to terminate a techyarrhythmia is administered to the heart of a subject, blood flow is measured, and if the measured blood flow is below a predetermined amount then a second signal, such as a series of packets of electrical pulses, is administered. One problem with such an approach is the need to wait until after defibrillation to monitor the patient before deciding whether to administer the post-treatment packets of pulses to treat the electromechanical dissociation.

U.S. Pat. No. 5,314,448 to Kroll et al. describes a process for defibrillation pretreatment of a heart in which an electrical pretreatment of a fibrillating heart is applied. The pretreatment is said to begin organizing the action of the chaotically contracting myocardial cells so that the defibrillating waveform applied after the pretreatment can accomplish its task with less energy than would otherwise be required. This reference is concerned with reducing shock energy and capacitor size for implantable defibrillation systems. This reference is not concerned with external defibrillation systems, is not concerned with treating PEA, and is not concerned with increasing the efficacy of defibrillation.

U.S. Pat. No. 5,978,705 to KenKnight et al. descries a method for treating cardiac arrhythmia in which an auxiliary pulse is delivered in conjunction with a primary pulse, with the auxiliary pulse being delivered to a weak field area relative to the primary pulse. The object of the auxiliary pulse is to alter the intrinsic patterns of recovery of excitability and thereby momentarily yield localized cessation of propagation by inactivating sodium ion conductance channels via elevation of the transmembrane potential (see, e.g., column 8, lines 59-66). This reference is not concerned with the treatment of PEA.

Accordingly, there remains a need for new ways to treat and reduce pulseless electrical activity, particularly PEA following the administration of a defibrillation waveform.

SUMMARY OF THE INVENTION

A first aspect of the present invention is a method of reducing the likelihood of onset of pulseless electrical activity after defibrillation in a subject afflicted with a fibrillating heart. The method comprises administering to a subject afflicted with fibrillation a first treatment waveform, the first treatment waveform insufficient to defibrillate the heart; and then administering to the subject a second treatment waveform that defibrillates the heart and restores organized electrical activity in the heart. The first treatment waveform reduces the likelihood of onset of pulseless electrical activity following the second treatment waveform, as compared to that likelihood which would be present in the absence of the first treatment waveform.

A second aspect of the present invention is a system for the defibrillation of the heart of a patient in need of such treatment. The system comprises a power supply and a controller operatively associated with the power supply, the controller configured for delivering a defibrillation sequence comprising a first treatment waveform, the first treatment waveform insufficient to defibrillate the heart, and then a second treatment waveform that defibrillates the heart and restores organized electrical activity in the heart. The first treatment waveform reducing the likelihood of onset of pulseless electrical activity following the second treatment waveform as compared to that likelihood which would be present in the absence of the first treatment waveform.

A third aspect of the present invention is a method for the external defibrillation of the heart of a patient afflicted with ventricular fibrillation. The method comprises externally administering to the patient a first treatment waveform, the first treatment waveform insufficient to defibrillate the heart, and then externally administering to the subject a second treatment waveform that defibrillates the heart and restores organized electrical activity in the heart.

A fourth aspect of the present invention is an external defibrillation system for the external defibrillation of the heart of a patient afflicted with ventricular fibrillation. The system comprises a power supply and a controller operatively associated with the power supply. The controller is configured for delivering a defibrillation sequence comprising a first treatment waveform, the first treatment waveform insufficient to defibrillate the heart, and then a second treatment waveform that defibrillates the heart and restores organized electrical activity in the heart.

A fifth aspect of the present invention is a method of reducing the likelihood of onset of pulseless electrical activity after defibrillation with an implantable defibrillator in a subject afflicted with a fibrillating heart. The method comprises the steps of administering to a subject afflicted with fibrillation a first treatment waveform, the first treatment waveform insufficient to defibrillate the heart, and then administering to the subject a second treatment waveform that defibrillates the heart and restores organized electrical activity in the heart. The first treatment waveform reduces the likelihood of onset of pulseless electrical activity following the second treatment waveform as compared to that likelihood which would be present in the absence of the first treatment waveform.

A sixth aspect of the present invention is an implantable defibrillator for defibrillating the heart of a subject in need thereof. The defibrillator comprises a power supply and a controller operatively associated with the power supply. The controller is configured for delivering a defibrillation sequence comprising a first treatment waveform, the first treatment waveform insufficient to defibrillate the heart; and then a second treatment waveform that defibrillates the heart and restores organized electrical activity in the heart. The first treatment waveform reduces the likelihood of onset of pulseless electrical activity following the second treatment waveform as compared to that likelihood which would be present in the absence of the first treatment waveform.

A further aspect of the present invention is a defibrillation system for the defibrillation of the heart of a patient afflicted with ventricular fibrillation. The system comprises a detector for detecting electrical activity from the heart of said patient during ventricular fibrillation; a power supply; a signal analyzer operatively associated with said detector and configured for determining the likelihood of pulseless electrical activity in said patient after delivery of a defibrillation treatment waveform to said patient; and a controller operatively associated with said power supply and said signal analyzer, said controller configured for delivering a defibrillation sequence, said defibrillation sequence optionally comprising a first treatment waveform, said first treatment waveform insufficient to defibrillate said heart, and then delivering a second treatment waveform that defibrillates said heart and restores organized electrical activity in said heart. The first treatment waveform is delivered when a high likelihood of pulseless electrical activity after defibrillation is determined, and said first treatment waveform is not delivered when a low likelihood of pulseless electrical activity after defibrillation is determined.

The foregoing and other objects and aspects of the present invention are explained in greater detail in the drawings herein and the specification below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an embodiment of a defibrillation sequence of the present invention.

FIG. 1B illustrates a second embodiment of a defibrillation sequence of the present invention.

FIG. 1C illustrates a third embodiment of a defibrillation sequence of the present invention.

FIG. 1D illustrates a fourth embodiment of a defibrillation sequence of the present invention.

FIG. 2 illustrates an implantable cardioverter/defibrillator of the present invention.

FIG. 3 schematically illustrates control circuitry in an implantable cardioverter/defibrillator according to FIG. 2.

FIG. 4 illustrates an external defibrillator of the present invention.

FIG. 5 illustrates control circuitry in an external defibrillator according to FIG. 4.

FIG. 6 shows, for comparative and background purposes, a tracing of arterial blood pressure (ABP) recorded while a series of pulse packets were delivered to the heart during normal sinus rhythm.

FIG. 7 shows the effect of the pulse therapy when delivered during VF.

FIG. 8 shows the time course of recovery of ABP following successful defibrillation.

FIG. 9 shows the effect of changing packet pulse duration and strength. Pulse durations tested were 0.5 msec, 1 msec, and 2 msec.

FIG. 10 shows the heart rate response to pulse therapy. Panel A: Heart rate following 15 pulses. Panel B: Heart rate following 30 pulses. Heart rate was significantly higher following 1, 2, 5, and 10 Amp pulse therapy than following defibrillation with no burst stimulation (control). There was no significant difference in heart rate following 15 therapy pulses compared to following 30 therapy pulses.

FIG. 11 shows the left ventricular pressure response to pulse therapy. Panel A: Systolic left ventricular pressure following 15 1-msec pulses. Panel B: Systolic left ventricular pressure following 30 1-msec pulses. Left ventricular systolic pressure was signif


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