Parasympathetic stimulation for termination of non-sinus atrial tachycardia

• US 20070203527A1
• Filed: 03/16/2007
• Published: 08/30/2007
• Est. Priority Date: 05/23/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Cohen, Ehud, Ben-David, Tamir, Ben-Ezra, Omry
• Granted Patent: US 8,060,197 B2
• Time in Patent Office: Days
• US Class Current: 607/14
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

Abstract

Apparatus is provided, which includes an electrode device, configured to be coupled to an atrial site of a subject containing parasympathetic nervous tissue, and a control unit. The control unit is configured to, responsively to a detection of an episode of non-sinus atrial tachycardia, restore normal sinus rhythm (NSR) of the subject, by driving the electrode device to apply a parasympathetic stimulation signal to the atrial site, and configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue sufficiently to restore the NSR. Other embodiments are also described.

Claims

1. Apparatus comprising:

an electrode device, configured to be coupled to an atrial site of a subject containing parasympathetic nervous tissue; and

a control unit, configured to, responsively to a detection of an episode of non-sinus atrial tachycardia, restore normal sinus rhythm (NSR) of the subject, by;

driving the electrode device to apply a parasympathetic stimulation signal to the atrial site, and

configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue sufficiently to restore the NSR.

2. The apparatus according to claim 1, wherein the non-sinus atrial tachycardia includes atrial fibrillation (AF), and wherein the control unit is configured to restore the NSR responsively to the detection of the episode of the AF.

3. The apparatus according to claim 1, wherein the non-sinus atrial tachycardia includes atrial flutter, and wherein the control unit is configured to restore the NSR responsively to the detection of the episode of the atrial flutter.

4. The apparatus according to claim 1, wherein the electrode device comprises an intravascular electrode lead.

5. The apparatus according to claim 1, wherein the electrode device is configured to be placed at an epicardial site.

6. The apparatus according to claim 1, wherein the atrial site is selected from the group consisting of:

an area around pulmonary veins in a left atrium, a site in a vicinity of an insertion of a superior vena cava vein into a right atrium, an atrial fat pad, a sinoatrial (SA) node fat pad, a pulmonary vein fat pad, and a site in the left atrium in the vicinity of an insertion of a pulmonary vein, and wherein the electrode device is configured to be coupled to the selected atrial site.

7. The apparatus according to claim 1, wherein the atrial site is selected from the group consisting of:

a site along an atrioventricular groove, a site along a coronary sinus, and a site along an intraatrial groove, and wherein the electrode device is configured to be coupled to the selected atrial site.

8. The apparatus according to claim 1, wherein the control unit is configured to apply the parasympathetic stimulation signal at between 50 and 200 pulses per second.

9. The apparatus according to claim 1, wherein the control unit is configured to configure the parasympathetic stimulation signal to include at least one monophasic pulse, and wherein the control unit is configured to withhold discharging the atrial site for at least 5 ms after completing application of the at least one monophasic pulse.

10. The apparatus according to claim 1, wherein the control unit is configured to restore the NSR by:

driving the electrode device to apply the parasympathetic stimulation signal and configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue at a first strength during a first stimulation session, and

responsively to a determination that the episode has not been resolved, driving the electrode device to apply the parasympathetic stimulation signal and configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue at a second strength during a second stimulation session subsequent to the first stimulation session, wherein the second strength is greater than the first strength.

14. The apparatus according to claim 1, wherein the electrode device is configured to sense electrical activity at the atrial site, and wherein the detection is performed at least partially responsively to the sensed electrical activity.

18. The apparatus according to claim 1, wherein the control unit is configured to apply a cardiac muscle signal to at least one atrium of the subject selected from the group consisting of:

an atrium including the atrial site, and an atrium contralateral to the atrium including the atrial site, and to configure the cardiac muscle signal to stimulate cardiac muscle tissue.

19. The apparatus according to claim 18, wherein the at least one atrium includes the atrium including the atrial site, and wherein the control unit is configured to drive the electrode device to apply the cardiac muscle signal to the atrial site.

33. The apparatus according to claim 1, wherein the control unit is configured to apply the parasympathetic stimulation signal during a ventricular refractory period of the cardiac cycle.

34. The apparatus according to claim 1, wherein the control unit is configured to begin to apply the parasympathetic stimulation signal after a delay after the detection, if the episode has not been resolved during the delay.

11-13. -13. (canceled)

15-17. -17. (canceled)

20-32. -32. (canceled)

35-37. -37. (canceled)

38. Apparatus comprising:

an electrode device, configured to be coupled to a site of a subject containing parasympathetic nervous tissue; and

a control unit, configured to;

responsively to a detection of an episode of non-sinus atrial tachycardia, wait during a delay period, and

upon conclusion of the delay period, responsively to a determination that the episode has not been resolved, restore normal sinus rhythm (NSR) of the subject by;

driving the electrode device to apply a parasympathetic stimulation signal to the site, and

configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue sufficiently to restore the NSR.

39. The apparatus according to claim 38, wherein the delay period has a duration of at least ten seconds.

40. The apparatus according to claim 38, wherein the non-sinus atrial tachycardia includes atrial fibrillation (AF), and wherein the control unit is configured to restore the NSR responsively to the detection of the episode of the AF.

41. The apparatus according to claim 38, wherein the non-sinus atrial tachycardia includes atrial flutter, and wherein the control unit is configured to restore the NSR responsively to the detection of the episode of the atrial flutter.

44. The apparatus according to claim 38, wherein the site is selected from the group consisting of:

a vagus nerve, an epicardial fat pad, a sinoatrial (SA) node fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a jugular vein, an azygos vein, an innominate vein, a subclavian vein, a right ventricle, a right atrium, an area around pulmonary veins in a left atrium, a site in a vicinity of an insertion of a superior vena cava vein into a right atrium, an atrial fat pad, a pulmonary vein fat pad, and a site in the left atrium in the vicinity of an insertion of a pulmonary vein, and wherein the electrode device is configured to be applied to the selected site.

45. The apparatus according to claim 38, wherein the site is selected from the group consisting of:

a site along an atrioventricular groove, a site along a coronary sinus, and a site along an intraatrial groove, and wherein the electrode device is configured to be coupled to the selected site.

42-43. -43. (canceled)

46-91. -91. (canceled)

92. A method comprising:

detecting an episode of non-sinus atrial tachycardia of a subject; and

responsively to the detecting, restoring normal sinus rhythm (NSR) of the subject, by;

applying a parasympathetic stimulation signal to an atrial site of the subject containing parasympathetic nervous tissue, and

configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue sufficiently to restore the NSR.

93. The method according to claim 92, wherein the non-sinus atrial tachycardia includes atrial fibrillation (AF), and wherein detecting the episode comprises detecting the episode of the AF.

94. The method according to claim 92, wherein the non-sinus atrial tachycardia includes atrial flutter, and wherein detecting the episode comprises detecting the episode of the atrial flutter.

95. The method according to claim 92, wherein applying the parasympathetic stimulation signal comprises applying the parasympathetic stimulation signal from an intravascular site.

96. The method according to claim 92, wherein applying the parasympathetic stimulation signal comprises applying the parasympathetic stimulation signal from an epicardial site.

97. The method according to claim 92, wherein the atrial site is selected from the group consisting of:

an area around pulmonary veins in a left atrium, a site in a vicinity of an insertion of a superior vena cava vein into a right atrium, an atrial fat pad, a sinoatrial (SA) node fat pad, a pulmonary vein fat pad, and a site in the left atrium in the vicinity of an insertion of a pulmonary vein, and wherein applying the parasympathetic stimulation signal comprises applying the parasympathetic stimulation signal to the selected atrial site.

98. The method according to claim 92, wherein the atrial site is selected from the group consisting of:

a site along an atrioventricular groove, a site along a coronary sinus, and a site along an intraatrial groove, and wherein applying the parasympathetic stimulation signal comprises applying the parasympathetic stimulation signal to the selected atrial site.

99. The method according to claim 92, wherein configuring the parasympathetic stimulation signal comprises applying the parasympathetic stimulation signal at between 50 and 200 pulses per second.

100. The method according to claim 92, wherein configuring the parasympathetic stimulation signal comprises configuring the parasympathetic stimulation signal to include at least one monophasic pulse, and withhold discharging the atrial site for at least 5 ms after completing application of the at least one monophasic pulse.

101. The method according to claim 92, wherein restoring the NSR comprises restoring the NSR by:

applying the parasympathetic stimulation signal and configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue at a first strength during a first stimulation session, and

responsively to a determination that the episode has not been resolved, applying the parasympathetic stimulation signal and configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue at a second strength during a second stimulation session subsequent to the first stimulation session, wherein the second strength is greater than the first strength.

105. The method according to claim 92,

wherein applying the parasympathetic stimulation signal comprises:

coupling an electrode device to the atrial site; and

applying the parasympathetic stimulation signal using the electrode device, and

wherein detecting comprises;

sensing electrical activity at the atrial site using the electrode device; and

detecting at least partially responsively to the sensed electrical activity.

109. The method according to claim 92, comprising applying a cardiac muscle signal to at least one atrium of the subject selected from the group consisting of:

an atrium including the atrial site, and an atrium contralateral to the atrium including the atrial site, and configuring the cardiac muscle signal to stimulate cardiac muscle tissue.

110. The method according to claim 109, wherein the at least one atrium includes the atrium including the atrial site, and wherein applying the cardiac muscle signal comprises applying the cardiac muscle signal to the atrial site.

124. The method according to claim 92, wherein synchronizing comprises applying the parasympathetic stimulation signal during a ventricular refractory period of the cardiac cycle.

125. The method according to claim 92, wherein applying the parasympathetic stimulation signal comprises beginning to apply the parasympathetic stimulation signal after a delay after the detecting, if the episode has not been resolved during the delay.

129. The method according to claim 92, wherein configuring the parasympathetic stimulation signal comprises setting, during a calibration procedure, at least one parameter of the parasympathetic stimulation signal to have a minimum value sufficient to achieve a desired effect.

134. The method according to claim 92, wherein configuring the parasympathetic stimulation signal comprises determining, during a calibration procedure, a maximum value of at least one parameter of the parasympathetic stimulation signal that is safe for the subject.

138. The method according to claim 92, comprising performing, prior to detecting the episode, an acute test to determine whether the subject is expected to benefit from the applying the parasympathetic stimulation signal.

102-104. -104. (canceled)

106-108. -108. (canceled)

111-123. -123. (canceled)

126-128. -128. (canceled)

130-133. -133. (canceled)

135-137. -137. (canceled)

139. (canceled)

140. A method comprising:

detecting of an episode of non-sinus atrial tachycardia of a subject;

responsively to the detecting, waiting during a delay period; and

upon conclusion of the delay period, responsively to a determination that the episode has not been resolved, restoring normal sinus rhythm (NSR) of the subject by;

applying a parasympathetic stimulation signal to a site of a subject containing parasympathetic nervous tissue, and

configuring the parasympathetic stimulation signal to activate the parasympathetic nervous tissue sufficiently to restore the NSR.

141. The method according to claim 140, wherein the delay period has a duration of at least ten seconds.

142. The method according to claim 140, wherein the non-sinus atrial tachycardia includes atrial fibrillation (AF), and wherein detecting the episode comprises detecting the episode of the AF.

143. The method according to claim 140, wherein the non-sinus atrial tachycardia includes atrial flutter, and wherein detecting the episode comprises detecting the episode of the atrial flutter.

144. The method according to claim 140, wherein the site is selected from the group consisting of:

a vagus nerve, an epicardial fat pad, a sinoatrial (SA) node fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a jugular vein, an azygos vein, an innominate vein, a subclavian vein, a right ventricle, a right atrium, an area around pulmonary veins in a left atrium, a site in a vicinity of an insertion of a superior vena cava vein into a right atrium, an atrial fat pad, a pulmonary vein fat pad, and a site in the left atrium in the vicinity of an insertion of a pulmonary vein, and wherein applying the parasympathetic stimulation signal comprises applying the parasympathetic stimulation signal to the selected site.

145. The method according to claim 140, wherein the site is selected from the group consisting of:

a site along an atrioventricular groove, a site along a coronary sinus, and a site along an intraatrial groove, and wherein applying the parasympathetic stimulation signal comprises applying the parasympathetic stimulation signal to the selected site.

146-186. -186. (canceled)