Implantable medical device having a controlled diagnostic function

• US 20040102816A1
• Filed: 11/26/2002
• Published: 05/27/2004
• Est. Priority Date: 11/26/2002
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kenknight, Bruce H., Mazar, Scott Thomas
• Granted Patent: US 7,333,853 B2
• Time in Patent Office: Days
• US Class Current: 607/27
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

Methods and systems for providing an implantable medical device with a controlled diagnostic function adapted to convert from a monitoring mode to a therapeutic mode upon sensing an actionable cardiovascular event are disclosed. A preferred embodiment uses an interactive control module to selectively control a plurality of gated circuits that turn the sensing, therapeutic and communications functions of the device on and off to conserve battery power and extend the life of the device. Some embodiments of a system disclosed herein also can be configured as a component of an Advanced Patient Management System that helps better monitor, predict and manage chronic diseases.

Claims

1. A method for diagnosing a cardiovascular event and delivering therapy using a convertible implantable medical device, comprising the steps of:

a. powering operation of the convertible medical device;

b. controlling a plurality of successive duty cycles of the implantable medical device to sense or treat or communicate a cardiovascular event;

c. sensing a cardiovascular event;

d. analyzing the sensed cardiovascular event;

e. diagnosing the analyzed cardiovascular event to deliver an appropriate course of therapy;

f. delivering the appropriate course of therapy; and

g. communicating patient health data reflected by the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to allow interactive communication with the convertible medical device.

2. The method of claim 1, wherein the step of powering operation of the convertible implantable medical device comprises the further step of powering the device with a battery.

3. The method of claim 2, wherein the step of powering operation of the convertible implantable medical device with a battery further comprises powering the device for at least 7 years.

4. The method of claim 2, wherein the step of powering operation of the convertible implantable medical device comprises the further step of powering the device with a battery comprising lithium.

5. The method of claim 4, wherein the step of powering operation of the convertible implantable medical device with a battery comprising lithium comprises the further step of powering the device for at 7 least years.

6. The method of claim 1, wherein the method comprises the further step of converting the convertible implantable medical device from a monitoring and communication mode to an intervention mode upon sensing a cardiovascular event requiring therapeutic intervention.

7. The method of claim 6, wherein the method comprises the further step of communicating patient health to a control and analysis module.

8. The method of claim 6, wherein the method comprises the further step of communicating patient health to a control module.

9. The method of claim 6, wherein the method comprises the further step of communicating patient health to a patient management system.

10. The method of claim 1, wherein the step of controlling a plurality of successive duty cycles comprises the further step of selectively controlling gated circuits.

11. The method of claim 10, wherein the step of selectively controlling gated circuits comprises the further step of controlling gated circuits S, T and C to open and closed states.

12. The method of claim 11, wherein the step of selectively controlling gated circuits S, T and C to open and closed states comprises the further step of opening and closing gated circuits S, T and C in any combination of open and closed states relative to each other.

13. The method of claim 11, wherein the step of selectively controlling gated circuit S comprises the further step of closing gated circuit S to activate a sensing module to sense a cardiovascular event.

14. The method of claim 13, wherein the step of selectively controlling gated circuit T comprises the further step of closing gated circuit T to activate a therapy module to deliver therapy.

15. The method of claim 14, wherein the step of delivering therapy comprises the further step of delivering an electrical stimulus.

16. The method of claim 14, wherein the step of delivering therapy comprises the further step of delivering a chemotherapeutic agent.

17. The method of claim 13, wherein the step of selectively controlling gated circuit C comprises the further step of closing gated circuit C to activate a communications module to communicate the sensed cardiovascular event.

18. The method of claim 14, wherein the step of selectively controlling gated circuit C comprises the further step of closing gated circuit C to activate a communications module to communicate the delivered therapy.

19. The method of claim 11, wherein the step of selectively controlling gated circuit S comprises the further step of duty cycling gated circuit S to a closed state to activate the sensing module to sense a cardiovascular event and to an open state to deactivate the sensing module to conserve power if no cardiovascular event is sensed.

20. The method of claim 13, wherein the step of selectively controlling gated circuit S to the closed state comprises the further step of gated circuit S being closed for a number of cardiac cycles.

21. The method of claim 20, wherein the step of gated circuit S being closed for a number of cardiac cycles comprises the further step of gated circuit S being closed for 1 cardiac cycle.

22. The method of claim 13, wherein the step of selectively controlling gated circuit S to the closed state comprises the further step of gated circuit S being closed for a physiologically appropriate time interval.

23. The method of claim 13, wherein the step of selectively controlling gated circuit S to the closed state comprises the further step of gated circuit S being closed for a technologically appropriate time interval.

24. The method of claim 11, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit S is closed, then gated circuit T is closed temporarily.

25. The method of claim 13, wherein the step of selectively controlling gated circuit S comprises the further step of when gated circuit S is closed, then gated circuit T is closed temporarily.

26. The method of claim 11, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit S is closed, then gated circuit T is closed permanently.

27. The method of claim 13, wherein the step of selectively controlling gated circuit S comprises the further step of when gated circuit S is closed, then gated circuit T is closed permanently.

28. The method of claim 19, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

29. The method of claim 20, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

30. The method of claim 21, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

31. The method of claim 22, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

32. The method of claim 23, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

33. The method of claim 24, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

34. The method of claim 25, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

35. The method of claim 26, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

36. The method of claim 27, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

37. The method of claim 19, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

38. The method of claim 20, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

39. The method of claim 21, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

40. The method of claim 22, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

41. The method of claim 23, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

42. The method of claim 24, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

43. The method of claim 25, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

44. The method of claim 26, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

45. The method of claim 27, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

46. The method of claim 1, wherein the step of controlling the plurality of duty cycles of the implantable medical device comprises the further step of timing a duty cycle for a time interval of less than 60 minutes.

47. The method of claim 46, wherein the step of timing the duty cycle comprises the further step of timing the duty cycle for a time interval of not more than 2 minutes.

48. The method of claim 47, wherein the step of timing the duty cycle comprises the further step of timing the duty cycle for a time interval of not less than 10 seconds.

49. The method of claim 11, wherein the step of selectively controlling gated circuit S comprises the further step of closing gated circuit S to activate a sensing module to sense and analyze a cardiovascular event.

50. The method of claim 49, wherein the step of selectively controlling gated circuit T comprises the further step of closing gated circuit T to activate a therapy module to deliver therapy.

51. The method of claim 50, wherein the step of delivering therapy comprises the further step of delivering an electrical stimulus.

52. The method of claim 50, wherein the step of delivering therapy comprises the further step of delivering a chemotherapeutic agent.

53. The method of claim 49, wherein the step of selectively controlling gated circuit C comprises the further step of closing gated circuit C to activate a communications module to communicate the sensed and analyzed cardiovascular event.

54. The method of claim 49, wherein the step of selectively controlling gated circuit C comprises the further step of closing gated circuit C to activate a communications module to communicate the delivered therapy.

55. The method of claim 11, wherein the step of selectively controlling gated circuit S comprises the further step of duty cycling gated circuit S to a closed state to activate the sensing module to sense a cardiovascular event and to an open state to deactivate the sensing module to conserve power if no cardiovascular event is sensed.

56. The method of claim 49, wherein the step of selectively controlling gated circuit S to the closed state comprises the further step of gated circuit S being closed for a number of cardiac cycles.

57. The method of claim 56, wherein the step of gated circuit S being closed for a number of cardiac cycles comprises the further step of gated circuit S being closed for 1 cardiac cycle.

58. The method of claim 49, wherein the step of selectively controlling gated circuit S to the closed state comprises the further step of gated circuit S being closed for a physiologically appropriate time interval.

59. The method of claim 49, wherein the step of selectively controlling gated circuit S to the closed state comprises the further step of gated circuit S being closed for a technologically appropriate time interval.

60. The method of claim 49, wherein the step of selectively controlling gated circuit S comprises the further step of when gated circuit S is closed, then gated circuit T is closed temporarily.

61. The method of claim 49, wherein the step of selectively controlling gated circuit S comprises the further step of when gated circuit S is closed, then gated circuit T is closed permanently.

62. The method of claim 55, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

63. The method of claim 56, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

64. The method of claim 57, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

65. The method of claim 58, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

66. The method of claim 59, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

67. The method of claim 60, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

68. The method of claim 61, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed temporarily.

69. The method of claim 55, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

70. The method of claim 56, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

71. The method of claim 57, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

72. The method of claim 58, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

73. The method of claim 59, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

74. The method of claim 60, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

75. The method of claim 61, wherein the step of selectively controlling the gated circuits comprises the further step of when gated circuit T is closed, then gated circuit C is closed permanently.

76. The method of claim 1, wherein the step of controlling the plurality of duty cycles of the implantable medical device comprises the further step of timing a duty cycle for a time interval of less than 60 minutes.

77. The method of claim 76, wherein the step of timing the duty cycle comprises the further step of timing the duty cycle for a time interval of not more than 2 minutes.

78. The method of claim 77, wherein the step of timing the duty cycle comprises the further step of timing the duty cycle for a time interval of not less than 10 seconds.

79. The method of claim 1, wherein the step of sensing the cardiovascular event comprises the further step of sensing an arrhythmic event.

80. The method of claim 79, wherein the step of sensing the arrhythmic event comprises the further step of sensing a bradycardia event.

81. The method of claim 79, wherein the step of sensing the arrhythmic event comprises the further step of sensing a tachycardia event.

82. The method of claim 79, wherein the step of sensing the arrhythmic event comprises the further step of sensing a fibrillation event.

83. The method of claim 1, wherein the step of analyzing the sensed cardiovascular event comprises the further step of using a pacemaker configured to analyze the cardiovascular event.

84. The method of claim 1, wherein the step of diagnosing the analyzed cardiovascular event to deliver an appropriate course of therapy comprises the further step of using a pacemaker configured to diagnose the cardiovascular event.

85. The method of claim 1, wherein the step of delivering the appropriate course of therapy comprises the further step of using a pacemaker to deliver the therapy.

86. The method of claim 1, wherein the step of delivering therapy comprises the further step of delivering an electrical stimulus.

87. The method of claim 1, wherein the step of delivering therapy comprises the further step of delivering a chemotherapeutic agent.

88. The method of claim 1, wherein the step of communicating data reflecting the cardiovascular event and delivered therapy comprises the further step of communicating the cardiovascular event and delivered therapy data to a control and analysis module to control further operation of the device.

89. The method of claim 1, wherein the step of communicating data reflecting the cardiovascular event and delivered therapy comprises the further step of communicating the cardiovascular event and delivered therapy data to a control module to control further operation of the device.

90. The method of claim 1, wherein the step of communicating data reflecting the cardiovascular event and delivered therapy comprises the further step of communicating the cardiovascular event and delivered therapy data to an externally accessible patient management system.

91. The method of claim 1, wherein the step of communicating data reflecting the cardiovascular event and delivered therapy comprises the further step of communicating the cardiovascular event and delivered therapy data for the purposes of a post-myocardial infarction randomized controlled trial.

92. A method for diagnosing a cardiovascular event and delivering therapy using a convertible implantable medical device, comprising the steps of:

a. powering the device using a lithium iodine battery;

b. controlling a plurality of successive duty cycles of the implantable medical device to sense a cardiovascular event using selectively controlled gates S, T and C selectively switched to open and closed states;

c. sensing an arrhythmic cardiovascular event;

d. analyzing the sensed arrhythmic cardiovascular event;

e. diagnosing the analyzed arrhythmic cardiovascular event to deliver an appropriate course of prophylactic therapy;

f. delivering the appropriate course of prophylactic therapy using an electrical stimulus; and

g. communicating data reflecting the sensed, analyzed and diagnosed arrhythmic cardiovascular event and delivered electrical stimulus therapy to control further operation of the convertible implantable medical device.

93. The method of claim 92, wherein the step of communicating data reflecting the sensed, analyzed and diagnosed arrhythmic cardiovascular event and delivered electrical stimulus therapy comprises the further step of communicating the cardiovascular event and delivered therapy data to an externally accessible patient management system.

94. The method of claim 92, wherein the step of communicating data reflecting the sensed, analyzed and diagnosed arrhythmic cardiovascular event and delivered electrical stimulus therapy comprises the further step of communicating the cardiovascular event and delivered therapy data for the purposes of a postmyocardial infarction randomized controlled trial.

95. The method of claim 92, wherein the step of selectively controlling gated circuits S, T and C by switching circuits S, T and C to open and closed states comprises the further step of switching gated circuits S, T and C to any combination of open and closed states relative to each other.

96. A convertible implantable medical device having diagnostic and therapeutic functions comprising:

a. an interactive control module adapted to selectively control a plurality of duty cycles that successively turn the functions of the device on and off through the use of gated circuits;

b. an interactive sensing module coupled to the interactive control module to sense a cardiovascular event;

c. an interactive analysis module integrated with the interactive control module to analyze and diagnose a cardiovascular event sensed by the interactive sensing module;

d. an interactive therapeutic module coupled to the interactive control module to deliver an appropriate course of therapy; and

e. an interactive communications module coupled to the interactive control module to communicate patient health data reflected by the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to allow interactive inquiry of the operation of the convertible medical device.

97. The convertible implantable medical device of claim 96, wherein the device further comprises a power source adapted to power operation of the convertible implantable medical device.

98. The power source of claim 97, wherein the power source further comprises a battery.

99. The battery of claim 98, wherein the battery is capable of powering operation of the convertible implantable medical device for at least 7 years.

100. The battery of claim 99, wherein the battery further comprises a lithium-based battery.

101. The battery of claim 100, wherein the lithium-based battery is capable of powering operation of the convertible implantable medical device for at least 7 years.

102. The convertible implantable medical device of claim 96, wherein the, device converts from a mode of monitoring and communicating patient health to an intervention mode upon sensing a cardiovascular event requiring therapeutic intervention.

103. The interactive control module of claim 96, wherein the analysis and diagnosis of the cardiovascular event uses a pacemaker configured to analyze and diagnose the cardiovascular event.

104. The interactive control module of claim 96, when the delivery of an appropriate course of therapy uses a pacemaker configured to deliver the therapy.

105. The interactive control module of claim 96, wherein the controlled plurality of duty cycles is controlled by selectively opening and closing gated circuits.

106. The selectively controlled gated circuits of claim 105, wherein the selectively controlled gated circuits comprise gated circuits S, T and C.

107. The selectively controlled gated circuits claim 106, wherein the selectively controlled gated circuits S, T and C are selectively controlled to any combination of open and closed states relative to each other.

108. The selectively controlled gated circuit S of claim 106, wherein the control module opens gated circuit S to deactivate the interactive sensing module and closes gated circuit S to activate the interactive sensing module.

109. The selectively controlled gated circuit T of claim 106, wherein the control module opens gated circuit T to deactivate the interactive therapy module and closes gated circuit T to activate the interactive therapy module.

110. The selectively controlled gated circuit C of claim 106, wherein the control module opens gated circuit C to deactivate the interactive communications module and closes gated circuit C to activate the interactive communications module.

111. The gated circuit S of claim 108, wherein the interactive sensing module is active to sense a cardiovascular event.

112. The gated circuit S of claim 108, wherein the interactive sensing module is adapted to duty cycle to an active state to sense a cardiovascular event and to an inactive state to save power if no cardiovascular event is sensed.

113. The gated circuit S of claim 108, wherein the interactive sensing module is active for a number of cardiac cycles.

114. The gated circuit S of claim 113, wherein the number of cardiac cycles is 3.

115. The gated circuit S of claim 108, wherein the interactive sensing module is active for a physiologically appropriate time interval.

116. The gated circuit S of claim 108, wherein the interactive sensing module is active for a technologically appropriate time interval.

117. The selectively controlled gated circuits of claim 106, wherein when gated circuit S is closed, then gated circuit T is closed temporarily.

118. The selectively controlled gated circuits of claim 106, wherein when gated circuit S is closed, then gated circuit T is closed permanently.

119. The selectively controlled gated circuits of claim 106, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

120. The selectively controlled gated circuits of claim 111, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

121. The selectively controlled gated circuits of claim 112, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

122. The selectively controlled gated circuits of claim 113, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

123. The selectively controlled gated circuits of claim 114, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

124. The selectively controlled gated circuits of claim 115, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

125. The selectively controlled gated circuits of claim 116, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

126. The selectively controlled gated circuits of claim 117, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

127. The selectively controlled gated circuits of claim 118, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

128. The selectively controlled gated circuits of claim 106, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

129. The selectively controlled gated circuits of claim 111, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

130. The selectively controlled gated circuits of claim 112, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

131. The selectively controlled gated circuits of claim 113, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

132. The selectively controlled gated circuits of claim 114, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

133. The selectively controlled gated circuits of claim 115, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

134. The selectively controlled gated circuits of claim 116, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

135. The selectively controlled gated circuits of claim 117, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

136. The selectively controlled gated circuits of claim 118, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

137. The convertible implantable medical device having diagnostic and therapeutic functions of claim 96, wherein the selectively controlled plurality of duty cycles of the implantable medical device that successively turn the functions of the device on and off is measured in time intervals of less than 60 minutes.

138. The selectively controlled plurality of duty cycles of claim 137, wherein the controlled plurality of duty cycles of the implantable medical device is measured in time intervals of not more than 2 minutes.

139. The selectively controlled plurality of duty cycles of claim 138, wherein the controlled plurality of duty cycles of the implantable medical device is measured in time intervals of not less than 30 seconds.

140. The interactive sensing module of claim 96, wherein the sensed cardiovascular event is an arrhythmic event.

141. The sensed cardiovascular event of claim 140, wherein the arrhythmic event is a bradycardia event.

142. The sensed cardiovascular event of claim 140, wherein the arrhythmic event is a tachycardia event.

143. The sensed cardiovascular event of claim 140, wherein the arrhythmic event is a fibrillation event.

144. The interactive therapeutic module of claim 96, wherein the therapeutic module delivers an electrical stimulus.

145. The interactive therapeutic module of claim 96, wherein the therapeutic module delivers a chemotherapeutic agent.

146. The interactive communications module of claim 96, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to a control and analysis module to control further operation of the device.

147. The interactive communications module of claim 96, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to a control module to control further operation of the device.

148. The interactive communications module of claim 96, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to an Advanced Patient Management system.

149. The interactive communications module of claim 96, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy for the purposes of a postmyocardial infarction randomized controlled trial.

150. A convertible implantable medical device having diagnostic and therapeutic functions comprising:

a. an interactive control module adapted to selectively control a plurality of duty cycles that successively turn the functions of the device on and off through the use of gated circuits;

b. an interactive sensing module coupled to the interactive control module to sense a cardiovascular event;

c. an interactive analysis module integrated with the interactive sensing module to analyze and diagnose a cardiovascular event sensed by the interactive sensing module;

d. an interactive therapeutic module coupled to the interactive control module to deliver an appropriate course of therapy; and

e. an interactive communications module coupled to the interactive control module to communicate patient health data reflected by the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to allow interactive inquiry of the operation of the convertible medical device.

151. The convertible implantable medical device of claim 150, wherein the device further comprises a power source adapted to power operation of the convertible implantable medical device.

152. The power source of claim 151, wherein the power source further comprises a battery.

153. The battery of claim 152, wherein the battery is capable of powering operation of the convertible implantable medical device for at least 7 years.

154. The battery of claim 152, wherein the battery further comprises a lithium-based battery.

155. The battery of claim 154, wherein the lithium-based battery is capable of powering operation of the convertible implantable medical device for at least 7 years.

156. The convertible implantable medical device of claim 150, wherein the device converts from a mode of monitoring and communicating patient health to an intervention mode upon sensing a cardiovascular event requiring therapeutic intervention.

157. The interactive sensing module of claim 150, wherein the analysis and diagnosis of the cardiovascular event uses a pacemaker configured to analyze and diagnose the cardiovascular event.

158. The interactive therapy module of claim 150, when the delivery of an appropriate course of therapy uses a pacemaker configured to deliver the therapy.

159. The interactive control module of claim 150, wherein the controlled plurality of duty cycles is controlled by selectively opening and closing gated circuits.

160. The selectively controlled gated circuits of claim 159, wherein the selectively controlled gated circuits comprise gated circuits S, T and C.

161. The selectively controlled gated circuits of claim 160, wherein the selectively controlled gated circuits S, T and C are selectively controlled to any combination of open and closed states relative to each other.

162. The selectively controlled gated circuit S of claim 160, wherein the control module opens gated circuit S to deactivate the interactive sensing module and closes gated circuit S to activate the interactive sensing module.

163. The selectively controlled gated circuit T of claim 160, wherein the control module opens gated circuit T to deactivate the interactive therapy module and closes gated circuit T to activate the interactive therapy module.

164. The selectively controlled gated circuit C of claim 160, wherein the control module opens gated circuit C to deactivate the interactive communications module and closes gated circuit C to activate the interactive communications module.

165. The gated circuit S of claim 162, wherein the interactive sensing module is active to sense a cardiovascular event.

166. The gated circuit S of claim 160, wherein the interactive sensing module is adapted to duty cycle to an active state to sense a cardiovascular event and to an inactive state to save power if no cardiovascular event is sensed.

167. The gated circuit S of claim 162, wherein the interactive sensing module is active for a number of cardiac cycles.

168. The gated circuit S of claim 167, wherein the number of cardiac cycles is 3.

169. The gated circuit S of claim 162, wherein the interactive sensing module is active for a physiologically appropriate time interval.

170. The gated circuit S of claim 162, wherein the interactive sensing module is active for a technologically appropriate time interval.

171. The selectively controlled gated circuits of claim 160, wherein when gated circuit S is closed, then gated circuit T is closed temporarily.

172. The selectively controlled gated circuits of claim 160, wherein when gated circuit S is closed, then gated circuit T is closed permanently.

173. The selectively controlled gated circuits of claim 160, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

174. The selectively controlled gated circuits of claim 165, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

175. The selectively controlled gated circuits of claim 166, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

176. The selectively controlled gated circuits of claim 167, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

177. The selectively controlled gated circuits of claim 168, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

178. The selectively controlled gated circuits of claim 169, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

179. The selectively controlled gated circuits of claim 170, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

180. The selectively controlled gated circuits of claim 171, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

181. The selectively controlled gated circuits of claim 172, wherein when gated circuit T is closed, then gated circuit C is closed temporarily.

182. The selectively controlled gated circuits of claim 160, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

183. The selectively controlled gated circuits of claim 165, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

184. The selectively controlled gated circuits of claim 166, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

185. The selectively controlled gated circuits of claim 167, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

186. The selectively controlled gated circuits of claim 168, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

187. The selectively controlled gated circuits of claim 169, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

188. The selectively controlled gated circuits of claim 170, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

189. The selectively controlled gated circuits of claim 171, wherein when gated circuit T is closed, then gated circuit C is closed perrnanently.

190. The selectively controlled gated circuits of claim 172, wherein when gated circuit T is closed, then gated circuit C is closed permanently.

191. The convertible implantable medical device having diagnostic and therapeutic functions of claim 150, wherein the selectively controlled plurality of duty cycles of the implantable medical device that successively turn the functions of the device on and off is measured in time intervals of less than 60 minutes.

192. The selectively controlled plurality of duty cycles of claim 191, wherein the controlled plurality of duty cycles of the implantable medical device is measured in time intervals of not more than 2 minutes.

193. The selectively controlled plurality of duty cycles of claim 192, wherein the controlled plurality of duty cycles of the implantable medical device is measured in time intervals of not less than 30 seconds.

194. The interactive sensing module of claim 150, wherein the sensed cardiovascular event is an arrhythmic event.

195. The sensed cardiovascular event of claim 194, wherein the arrhythmic event is a bradycardia event.

196. The sensed cardiovascular event of claim 194, wherein the arrhythmic event is a tachycardia event.

197. The sensed cardiovascular event of claim 194, wherein the arrhythmic event is a fibrillation event.

198. The interactive therapeutic module of claim 150, wherein the therapeutic module delivers an electrical stimulus.

199. The interactive therapeutic module of claim 150, wherein the therapeutic module delivers a chemotherapeutic agent.

200. The interactive communications module of claim 150, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to a control and analysis module to control further operation of the device.

201. The interactive communications module of claim 150, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to a control module to control further operation of the device.

202. The interactive communications module of claim 150, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy to an Advanced Patient Management system.

203. The interactive communications module of claim 150, wherein the communications module communicates data reflecting the sensed, analyzed and diagnosed cardiovascular event and delivered therapy for the purposes of a postmyocardial infarction randomized controlled trial.

204. A convertible implantable medical device having diagnostic and therapeutic functions comprising:

a. an interactive control module adapted to analyze and diagnose an arrhythmic cardiovascular event and control a plurality of duty cycles that successively turn the functions of the device on and off through the use of selectively controlled gated circuits S, T and C;

b. an interactive sensing module coupled to the interactive control module to sense an arrhythmic cardiovascular event;

c. an interactive analysis module integrated with the interactive control module to analyze and diagnose an arrhythmic cardiovascular event sensed by the interactive sensing module;

d. an interactive therapeutic module coupled to the interactive control module to deliver an appropriate course of prophylactic therapy in the form of an electrical stimulus; and

e. an interactive communications module coupled to the interactive control module to communicate data reflecting the analyzed and diagnosed arrhythmic cardiovascular event and delivered therapy to control further operation of the implantable medical device.

205. The implantable medical device of claim 204, wherein the device further comprises a lithium iodine battery power source adapted to power operation of the convertible implantable medical device.

206. The implantable medical device of claim 204, wherein the interactive communications module is further coupled to an externally accessible patent management system.

207. The implantable medical device of claim 204, wherein the interactive communications module is further coupled to an externally accessible patent management system for the purposes of a post-myocardial infarction randomized controlled trial.

208. A convertible implantable medical device having diagnostic and therapeutic functions comprising:

a. an interactive control module adapted to analyze and diagnose an arrhythmic cardiovascular event and control a plurality of duty cycles that successively turn the functions of the device on and off through the use of selectively controlled gated circuits S, T and C;

b. an interactive sensing module coupled to the interactive control module to sense an arrhythmic cardiovascular event;

c. an interactive analysis module integrated with the interactive sensing module to analyze and diagnose an arrhythmic cardiovascular event sensed by the interactive sensing module;

d. an interactive therapeutic module coupled to the interactive control module to deliver an appropriate course of prophylactic therapy in the form of an electrical stimulus; and

e. an interactive communications module coupled to the interactive control module to communicate data reflecting the analyzed and diagnosed arrhythmic cardiovascular event and delivered therapy to control further operation of the implantable medical device.

209. The implantable medical device of claim 208, wherein the device further comprises a lithium iodine battery power source adapted to power operation of the convertible implantable medical device.

210. The implantable medical device of claim 208, wherein the interactive communications module is further coupled to an externally accessible patent management system.

211. The implantable medical device of claim 208, wherein the interactive communications module is further coupled to an externally accessible patent management system for the purposes of a post-myocardial infarction randomized controlled trial.

212. A convertible implantable medical device having diagnostic and therapeutic functions, wherein the device is a component of an Advanced Patient Management system and comprises:

a. an interactive, electronically accessible data management module adapted to store patient and medical data;

b. an interactive control module adapted to selectively control a plurality of duty cycles that successively turn the functions of the device on and off through the use of gated circuits S, T and C;

c. an interactive sensing module coupled to the interactive control module adapted to sense physiological functions;

d. an interactive analysis module integrated with the interactive control module to analyze and diagnose a physiological function sensed by the interactive sensing module;

e. an interactive therapeutic module coupled to the interactive control module to deliver an appropriate course of therapy; and

f. an interactive communications module coupled to the interactive control module and data management module adapted to communicate patient health data reflected by the sensed, analyzed and diagnosed physiological function, medical data and delivered therapy to allow interactive inquiry of the operation of the convertible medical device.

213. A convertible implantable medical device having diagnostic and therapeutic functions, wherein the device is a component of an Advanced Patient Management system and comprises:

a. an interactive, electronically accessible data management module adapted to store patient and medical data;

b. an interactive control module adapted to selectively control a plurality of duty cycles that successively turn the functions of the device on and off through the use of gated circuits S, T and C;

c. an interactive sensing module coupled to the interactive control module adapted to sense physiological functions;

d. an interactive analysis module integrated with the interactive sensing module to analyze and diagnose a physiological function sensed by the interactive sensing module;

e. an interactive therapeutic module coupled to the interactive control module to deliver an appropriate course of therapy; and

f. an interactive communications module coupled to the interactive control module and data management module adapted to communicate patient health data reflected by the sensed, analyzed and diagnosed physiological function, medical data and delivered therapy to allow interactive inquiry of the operation of the convertible medical device.