Techniques for reducing pain associated with nerve stimulation

• US 20080065158A1
• Filed: 09/07/2006
• Published: 03/13/2008
• Est. Priority Date: 09/07/2006
• 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 7,904,176 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Apparatus is provided including an electrode device and a control unit. The electrode device is configured to be coupled to a site of a subject selected from the group consisting of: a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein. The control unit is configured to drive the electrode device to apply to the site a current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse, and set (a) a pulse repetition interval (PRI) of the first burst to be on average at least 20 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval between, the percentage being less than 67%. Other embodiments are also described.

Claims

1. Apparatus comprising:

an electrode device, configured to be coupled to a site of a subject selected from the group consisting of;

a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein; and

a control unit, configured to;

drive the electrode device to apply to the site a current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse, and

set (a) a pulse repetition interval (PRI) of the first burst to be on average at least 20 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

3. The apparatus according to claim 1, wherein the control unit is configured to set the percentage to be less than 33%.

4. The apparatus according to claim 1, wherein the control unit is configured to set the average PRI of the first burst to be less than 200 ms.

5. The apparatus according to claim 1, wherein the control unit is configured to set the interburst interval to be between 400 ms and 1500 ms.

6. The apparatus according to claim 1, wherein the control unit is configured to configure the first burst to include at least three pulses.

8. The apparatus according to claim 1, wherein the control unit is configured to set an average duration of the pulses of the first burst to be less than 4 ms.

9. The apparatus according to claim 1, wherein the site includes the vagus nerve, and wherein the electrode device is configured to be coupled to the vagus nerve.

16. The apparatus according to claim 1, wherein the control unit is configured to apply an interburst current to the site during at least a portion of the interburst gap, and to set the interburst current on average to be less than 20% of the current applied on average during the first burst.

22. The apparatus according to claim 1,

wherein the control unit is configured to:

drive the electrode device, during stimulation periods alternating with rest periods, to apply the current during “

on”

periods that alternate with low stimulation periods, the “

on”

periods having on average an “

on”

duration equal to at least 1 second, and the low stimulation periods having on average a low stimulation duration equal to at least 50% of the “

on”

duration, wherein at least one of the “

on”

periods includes the first and second bursts,

set the current applied on average during the low stimulation periods to be less than 20% of the current applied on average during the “

on”

periods, and

set the current applied on average during the rest periods to be less than 20% of the current applied on average during the “

on”

periods,

wherein the rest periods have on average a rest period duration equal to at least a cycle duration that equals a duration of a single “

on”

period plus a duration of a single low stimulation period, and

wherein the stimulation periods have on average a stimulation period duration equal to at least five times the rest period duration.

30. The apparatus according to claim 1, comprising a sensor configured to sense a physiological parameter of the subject indicative of physiological activity of the subject, wherein the control unit is configured to synchronize the first and second bursts with the physiological activity.

32. The apparatus according to claim 30, wherein the physiological activity includes cardiac activity of the subject, and wherein the control unit is configured to synchronize the first and second bursts with a feature of a cardiac cycle of the subject.

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34. Apparatus comprising:

an electrode device, configured to be coupled to a site of a subject selected from the group consisting of;

a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein; and

a control unit, configured to;

drive the electrode device, during stimulation periods that alternate with rest periods, to apply to the site a current during “

on”

periods that alternate with low stimulation periods, the “

on”

periods having on average an “

on”

duration equal to at least 1 second, and the low stimulation periods having on average a low stimulation duration equal to at least 50% of the “

on”

duration,

set the current applied on average during the low stimulation periods to be less than 20% of the current applied on average during the “

on”

periods, and

set the current applied on average during the rest periods to be less than 20% of the current applied on average during the “

on”

periods,

wherein the rest periods have on average a rest period duration equal to at least a cycle duration that equals a duration of a single “

on”

period plus a duration of a single low stimulation period, and

wherein the stimulation periods have on average a stimulation period duration equal to at least five times the rest period duration.

37. The apparatus according to claim 34, wherein the control unit is configured to set the rest period duration to be on average at least 30 seconds.

39. The apparatus according to claim 34, wherein the control unit is configured to set the stimulation period duration to be on average at least 30 times the cycle duration.

41. The apparatus according to claim 34, wherein the control unit is configured to:

drive the electrode device, during at least one of the “

on”

periods, to apply the current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse, and

set (a) a pulse repetition interval (PRI) of the first burst to be on average at least 20 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

49. The apparatus according to claim 34, wherein the control unit is configured to:

drive the electrode device to apply the current at least intermittently to the site for at least three hours, which at least three hours includes a period having a duration of three hours, which period is divided into a number of equal-duration sub-periods such that each of the sub-periods has a sub-period duration equal to three hours divided by the number, wherein the number is between 5 and 10,

configure the current to cause, during at least 20% of each of the sub-periods, an average reduction of at least 5% in a heart rate of the subject compared to a baseline heart rate of the subject, and

configure the current to not cause secondary neuropathic pain.

50. The apparatus according to claim 34, wherein the site includes the vagus nerve, and wherein the electrode device is configured to be coupled to the vagus nerve.

51. The apparatus according to claim 50, wherein the control unit is configured to:

drive the electrode device to apply the current at least intermittently to the vagus nerve for at least three hours, which at least three hours includes a period having a duration of three hours,

configure the stimulation to include at least 3000 pulses during the period, the pulses having on average a pulse duration of at least 0.5 ms,

configure the stimulation to cause, on average during the pulses, at least 3 mA to enter tissue of the vagus nerve, and

configure the stimulation to not cause secondary neuropathic pain.

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101. A method comprising:

applying, to a site of a subject, a current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse, the site selected from the group consisting of;

a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein; and

setting (a) a pulse repetition interval (PRI) of the first burst to be on average at least 20 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

103. The method according to claim 101, wherein setting comprises setting the percentage to be less than 33%.

104. The method according to claim 101, wherein setting comprises setting the average PRI of the first burst to be less than 200 ms.

105. The method according to claim 101, wherein setting comprises setting the interburst interval to be between 400 ms and 1500 ms.

106. The method according to claim 101, wherein applying comprises configuring the first burst to include at least three pulses.

108. The method according to claim 101, wherein applying the current comprises setting an average duration of the pulses of the first burst to be less than 4 ms.

109. The method according to claim 101, wherein the site includes the vagus nerve, and wherein applying the current comprises applying the current to the vagus nerve.

116. The method according to claim 101, wherein applying the current comprises applying an interburst current to the site during at least a portion of the interburst gap, and setting the interburst current on average to be less than 20% of the current applied on average during the first burst.

122. The method according to claim 101,

wherein applying the current comprises:

during stimulation periods alternating with rest periods, applying the current during “

on”

periods that alternate with low stimulation periods, the “

on”

periods having on average an “

on”

duration equal to at least 1 second, and the low stimulation periods having on average a low stimulation duration equal to at least 50% of the “

on”

duration, wherein at least one of the “

on”

periods includes the first and second bursts;

setting the current applied on average during the low stimulation periods to be less than 20% of the current applied on average during the “

on”

periods; and

setting the current applied on average during the rest periods to be less than 20% of the current applied on average during the “

on”

periods,

wherein the rest periods have on average a rest period duration equal to at least a cycle duration that equals a duration of a single “

on”

period plus a duration of a single low stimulation period, and

wherein the stimulation periods have on average a stimulation period duration equal to at least five times the rest period duration.

130. The method according to claim 101, wherein applying the current comprises sensing a physiological parameter of the subject indicative of physiological activity of the subject, and synchronizing the first and second bursts with the physiological activity.

132. The method according to claim 130, wherein the physiological activity includes cardiac activity of the subject, and wherein applying the current comprises synchronizing the first and second bursts with a feature of a cardiac cycle of the subject.

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134. A method comprising:

applying, to a site of a subject, during stimulation periods that alternate with rest periods, a current during “

on”

periods that alternate with low stimulation periods, the “

on”

periods having on average an “

on”

duration equal to at least 1 second, and the low stimulation periods having on average a low stimulation duration equal to at least 50% of the “

on”

duration, the site selected from the group consisting of;

a vagus nerve, an epicardial fat pad, a pulmonary vein, a carotid artery, a carotid sinus, a coronary sinus, a vena cava vein, a right ventricle, a right atrium, and a jugular vein;

setting the current applied on average during the low stimulation periods to be less than 20% of the current applied on average during the “

on”

periods;

setting the current applied on average during the rest periods to be less than 20% of the current applied on average during the “

on”

periods; and

setting the rest periods to have on average a rest period duration equal to at least a cycle duration that equals a duration of a single “

on”

period plus a duration of a single low stimulation period, and the stimulation periods to have on average a stimulation period duration equal to at least five times the rest period duration.

137. The method according to claim 134, wherein setting comprises setting the rest period duration to be on average at least 30 seconds.

139. The method according to claim 134, wherein applying the current comprises setting the stimulation period duration to be on average at least 30 times the cycle duration.

141. The method according to claim 134, wherein applying the current comprises:

during at least one of the “

on”

periods, applying the current in at least first and second bursts, the first burst including a plurality of pulses, and the second burst including at least one pulse; and

setting (a) a pulse repetition interval (PRI) of the first burst to be on average at least 20 ms, (b) an interburst interval between initiation of the first burst and initiation of the second burst to be less than 10 seconds, (c) an interburst gap between a conclusion of the first burst and the initiation of the second burst to have a duration greater than the average PRI, and (d) a burst duration of the first burst to be less than a percentage of the interburst interval, the percentage being less than 67%.

149. The method according to claim 134, wherein applying the current comprises:

applying the current at least intermittently for at least three hours, which at least three hours includes a period having a duration of three hours, which period is divided into a number of equal-duration sub-periods such that each of the sub-periods has a sub-period duration equal to three hours divided by the number, wherein the number is between 5 and 10;

configuring the current to cause, during at least 20% of each of the sub-periods, an average reduction of at least 5% in a heart rate of the subject compared to a baseline heart rate of the subject; and

configuring the current to not cause secondary neuropathic pain.

150. The method according to claim 134, wherein the site includes the vagus nerve, and wherein applying the current comprises applying the current to the vagus nerve.

151. The method according to claim 150, wherein applying the current comprises:

applying the current at least intermittently for at least three hours, which at least three hours includes a period having a duration of three hours;

configuring the current to include at least 3000 pulses during the period, the pulses having on average a pulse duration of at least 0.5 ms;

configuring the current to cause, on average during the pulses, at least 3 mA to enter tissue of the vagus nerve; and

configuring the current to not cause secondary neuropathic pain.

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