SELECTIVE HIGH FREQUENCY SPINAL CORD MODULATION FOR INHIBITING PAIN WITH REDUCED SIDE EFFECTS, AND ASSOCIATED SYSTEMS AND METHODS, INCLUDING IMPLANTABLE PATIENT LEADS

• US 20100274326A1
• Filed: 04/22/2010
• Published: 10/28/2010
• Est. Priority Date: 04/22/2009
• Status: Abandoned Application

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Thacker, James R., Chitre, Yougandh, Walker, Andre B., Alataris, Konstantinos
• Application Number:
  US12/765,805
• Publication Number:
  US 20100274326A1
• Time in Patent Office: Days
• US Class Current: 607/72
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36089 Addiction or withdrawal from substance abuse such as alcohol or drugs
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 : providing test stimulations
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: G01R 21/133 : by using digital technique

Abstract

Selective high-frequency spinal chord modulation for inhibiting pain with reduced side affects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient'"'"'s spinal chord region to address low back pain without creating unwanted sensory and/or motor side affects. In other embodiments, modulation in accordance with similar parameters can be applied to other spinal or peripheral locations to address other indications.

Claims

1-99. -99. (canceled)

100. A patient therapy device, comprising:

a patient-implantable lead body;

a connection element carried by the lead body and positioned to electrically couple to a patient-implantable pulse generator; and

multiple electrical contacts carried by the lead body and positioned relative to the lead body to contact patient tissue and deliver electrical signals to a patient, with immediately neighboring contacts spaced apart from each other by at least 8 millimeters.

101. The device of claim 100 wherein each of the immediately neighboring contacts has multiple edges, and wherein the spacing between immediately neighboring contacts is the spacing between the respective closest edges of each of the immediately neighboring contacts.

102. The device of claim 100 wherein different pairs of immediately neighboring contacts are spaced apart by different distances.

103. The device of claim 100, further comprising the patient-implantable signal generator, and wherein the lead body is electrically connected to the signal generator via the connector element.

104. The device of claim 100 wherein immediately neighboring contacts are spaced apart from each other by from about 8 millimeters to about 64 millimeters.

105. The device of claim 100 wherein immediately neighboring contacts are spaced apart from each other by at least 16 millimeters.

106. The device of claim 100 wherein immediately neighboring contacts are spaced apart from each other by at least 32 millimeters.

107. The device of claim 100 wherein immediately neighboring contacts are spaced apart from each other by approximately 64 millimeters.

108. The device of claim 100, further comprising:

a first conductor carried by the lead body and electrically connected to one of the immediately neighboring contacts;

a second conductor carried by the lead body and electrically connected to the other of the immediately neighboring contacts, the first and second conductors being electrically insulated from each other at the lead body.

109. The device of claim 108 wherein the one of the immediately neighboring contacts includes multiple, spaced-apart sub-contacts, with individual sub-contacts electrically connected to the first conductor.

110. The device of claim 108 wherein the lead body is elongated along a major axis, and wherein the first conductor includes a plurality of first generally parallel strands, with each aligned generally parallel to a neighboring first strand, and aligned generally parallel to the major axis.

111. The device of claim 100 wherein the lead body is elongated along a major axis, and wherein each contact carried by the lead body is positioned at least approximately the same distance from the major axis.

112. The device of claim 100 wherein the lead body has a length of from about 30 cm to about 150 cm.

113. The device of claim 100 wherein the lead body has a length of from about 40 cm to about 50 cm.

114. A method for treating a patient, comprising:

implanting a lead body along the patient'"'"'s spinal cord;

positioning a contact carried by the lead body at a first location along the patient'"'"'s spinal cord; and

positioning an immediately neighboring contact carried by the lead body at a second location along the patient'"'"'s spinal cord, with a spacing between the contact and the immediately neighboring contact being at least one half the length of an adjacent vertebral body; and

activating a signal generator to apply an electrical signal to the patient at a frequency of from about 3 kHz to about 50 kHz via the contacts.

115. The method of claim 114 wherein positioning an immediately neighboring contact includes positioning the immediately neighboring contact with a spacing between the contact and the immediately neighboring contact being at least the length of the adjacent vertebral body.

116. The method of claim 114 wherein positioning an immediately neighboring contact includes positioning the immediately neighboring contact with a spacing between the contact and the immediately neighboring contact being about twice the length of the adjacent vertebral body.

117. The method of claim 114 wherein positioning an immediately neighboring contact includes positioning the immediately neighboring contact with a spacing between the contact and the immediately neighboring contact being from about one half the length of the adjacent vertebral body to about twice the length of the adjacent vertebral body.

118. The method of claim 114 wherein activating the signal generator includes activating the signal generator at a frequency of from about 3 kHz to about 15 kHz.

119. The method of claim 114 wherein activating the signal generator includes activating the signal generator at a frequency of about 10 kHz.

120. A patient therapy device, comprising:

a patient-implantable lead body elongated along a lead axis;

a connection element carried by the lead body and positioned to electrically connect to a patient-implantable pulse generator; and

multiple contacts positioned along the lead axis to contact patient tissue and deliver electrical signals to a patient, the multiple contacts including;

a first set of first contacts having a first spacing between immediately neighboring first contacts; and

a second set of second contacts having a second spacing between immediately neighboring second contacts, the second spacing being different than the first spacing.

121. The device of claim 120 wherein the nearest contact to each first contact is another first contact, and the nearest contact to any second contact is another second contact.

122. The device of claim 120, further comprising the patient-implantable signal generator, and wherein the lead body is electrically connected to the signal generator.

123. The device of claim 122 wherein the signal generator is programmed with instructions that, when executed, direct first electrical signals to the first set of first contacts in accordance with first signal delivery parameters, and direct second electrical signals to the second set of second contacts in accordance with second signal delivery parameters different than the first signal delivery parameters.

124. The device of claim 120 wherein immediately neighboring first contacts are spaced apart from each other by at least 8 millimeters.

125. The device of claim 120 wherein immediately neighboring second contacts are spaced apart from each other by approximately 3 millimeters.

126. The device of claim 120 wherein each of the immediately neighboring first contacts has multiple edges, and wherein the spacing between immediately neighboring first contacts is the spacing between the respective closest edges of each of the immediately neighboring contacts.

127. The device of claim 120 wherein the lead body includes a variable-length portion between the first set of first contacts and the second set of second contacts.

128. The device of claim 127 wherein the variable-length portion has a helical shape.

129. The device of claim 128 wherein the variable length portion includes a stylet lumen, and wherein the variable-length portion is generally straight when a stylet is received in the stylet lumen, and helical when a stylet is not received in the lumen.

130. A method for treating a patient, comprising:

implanting a lead body along the patient'"'"'s spinal cord;

positioning at a first location along the spinal cord a first set of first contacts carried by the lead body and having a first spacing between immediately neighboring first contacts;

positioning at a second location along the spinal cord a second set of second contacts having a second spacing between immediately neighboring second contacts, the second spacing being different than the first spacing; and

activating a signal generator to apply an electrical signal to the patient at a frequency of from about 3 kHz to about 50 kHz via at least one of the first set of first contacts and the second set of second contacts.

131. The method of claim 130 wherein positioning the first set of contacts includes positioning the first set of contacts at a first vertebral level, and wherein positioning the second of contacts includes positioning the second set of contacts at a second vertebral level different than the first vertebral level.

132. The method of claim 130 wherein activating a signal generator includes activating a signal generator to apply a first signal to the first contacts at a frequency of from about 3 kHz to about 50 kHz, and a second signal to the second contacts at a frequency of less than 1,500 Hz.

133. The method of claim 130 wherein positioning the first contacts includes positioning the first contacts in electrical communication with a first neural population, and wherein positioning the second contacts includes positioning the second contacts in electrical communication with a second neural population different than the first.

134. The method of claim 130 wherein activating a signal generator includes applying a first signal having first signal delivery parameters to the first contacts, and applying a second signal having second signal delivery parameters to the second contacts, the second signal delivery parameters being different than the first signal delivery parameters.

135. The method of claim 130, further comprising adjusting a length of an intermediate portion of the lead body between the first set of first contacts and the second set of second contacts to establish a spacing between the first set and the second set.

136. The method of claim 135 wherein establishing the spacing includes establishing the spacing so that the first contacts are positioned at a thoracic vertebral level and the second contacts are positioned at a cervical vertebral level.

137. The method of claim 135 wherein the intermediate portion has a helical shape, and wherein adjusting the length of the intermediate portion includes:

inserting a stylet into a stylet lumen of the lead body to straighten the lead body;

inserting the stylet and the lead body along the patient'"'"'s spinal cord;

fixing a distal portion of the lead body relative to the patient;

at least partially removing the stylet from the stylet lumen; and

fixing a proximal portion of the lead body relative to the patient.