NERVE REGENERATION SYSTEM AND LEAD DEVICES ASSOCIATED THEREWITH

• US 20100152811A1
• Filed: 06/29/2007
• Published: 06/17/2010
• Est. Priority Date: 06/30/2006
• Status: Abandoned Application

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Flaherty, Christopher J.
• Application Number:
  US12/305,225
• Publication Number:
  US 20100152811A1
• Time in Patent Office: Days
• US Class Current: 607/50
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36121 Production of neurotransmitters; Modulation of genes expression
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Various systems and methods for promoting nerve regeneration are disclosed. The system may include an elongated lead configured to be implanted within a patient'"'"'s body. The system may also include a plurality of electrodes disposed along the elongated lead and configured to deliver electric stimulation to an area of a patient'"'"'s body. The plurality of electrodes may comprise at least one transmitting electrode in communication with the controller, wherein the at least one transmitting electrode is configured to transmit an electric signal to one or more other electrodes. The controller may be configured to control operation of the at least one transmitting electrode.

Claims

1. A method for treating a body comprising:

implanting an elongated lead within a patient'"'"'s body, the elongated lead having a plurality of electrodes configured to deliver electric stimulation to an area of the patient'"'"'s body;

selecting at least one transmitting electrode from among the plurality of electrodes; and

causing the at least one transmitting electrode to transmit an electric signal to one or more other electrodes to stimulate a damaged nerve.

2. The method of claim 1, further comprising implanting the elongated lead proximate the patient'"'"'s spine.

3. The method of claim 1, wherein selecting the at least one transmitting electrode includes:

determining a location of the damaged nerve; and

selecting the at least one transmitting electrode based on the determined location.

4. The method of claim 1, further comprising monitoring the patient'"'"'s response to the electric signal.

5. The method of claim 1, further comprising causing the at least one electrode to transmit the electric signal to a first receiving electrode during a first time interval and transmit the electric signal to a second receiving electrode during a second time interval.

6. The method of claim 1, further comprising causing the at least one electrode to simultaneously transmit the electric signal to a first receiving electrode and a second receiving electrode.

7. The method of claim 1, further comprising modifying at least one parameter associated with the plurality of electrodes to modify the electric stimulation applied to the area of the patient'"'"'s body.

9. The method of claim 1, further comprising securing at least a portion of the lead proximate the area of the patient'"'"'s body.

10. The method of claim 1, wherein causing the at least one transmitting electrode to transmit electric energy includes providing a command signal to a controller, wherein the controller is configured to energize the at least one transmitting electrode in response to the command signal.

12. The method of claim 1, wherein the electric signal comprises an electric current pulse.

8. (canceled)

11. (canceled)

13. A system used for a nerve regeneration treatment, comprising:

a controller;

an elongated lead configured to be implanted within a patient'"'"'s body; and

a plurality of electrodes disposed along the elongated lead and configured to deliver electric stimulation to an area of a patient'"'"'s body, the plurality of electrodes comprising at least one transmitting electrode in communication with the controller,

wherein the at least one transmitting electrode is configured to transmit an electric signal to one or more other electrodes, and

wherein the controller is configured to control operation of the at least one transmitting electrode.

14. The system of claim 13, wherein the electric signal comprises an electric current pulse.

15. The system of claim 13, wherein the controller controls at least one of:

direction, strength, frequency, and oscillating pattern of an electric field applied to the area.

16. The system of claim 13, wherein the controller controls at least one of:

duration of the transmission;

sequence of the transmission between electrodes; and

signal level of the transmission.

19. The system of claim 13, wherein the controller is configured to designate the transmitting electrode from the plurality of electrodes.

21. The system of claim 13, wherein the at least one transmitting electrode is configured to simultaneously transmit the electric signal to a first receiving electrode and a second receiving electrode.

22. The system of claim 13, wherein the at least one transmitting electrode is configured to transmit the electric signal to a first receiving electrode during a first time interval and transmit the electric signal to a second receiving electrode during a second time interval.

23. The system of claim 13, wherein at least one of the plurality of electrodes is configured to monitor the patient'"'"'s response to the applied nerve generation treatment.

24. The system of claim 23, wherein the controller is configured to modify at least one parameter associated with the plurality of electrodes to modify the electric stimulation applied to the area of the patient'"'"'s body.

26. The system of claim 13, wherein the lead comprises a securing device configured to secure at least a portion of the lead proximate the area of the patient'"'"'s body.

17-18. -18. (canceled)

20. (canceled)

25. (canceled)

27. A method for treating a body comprising:

implanting a first elongated lead in a patient'"'"'s body, the first elongated lead having a first electrode;

implanting a second elongated lead within a patient'"'"'s body, the second elongated lead having a second electrode; and

sequentially energizing the first and second electrodes to create an oscillating electromagnetic field between the electrodes.

28. The method of claim 27, wherein the first electrode is configured to transmit an electric signal to the second electrode.

29. The method of claim 28, further comprising selecting the first electrode from among a plurality of electrodes.

30. The method of claim 27, further comprising monitoring the patient'"'"'s response to the electromagnetic field.

31. The method of claim 27, further comprising modifying at least one parameter associated with the first and second electrodes to modify the oscillating electromagnetic field.

32. The method of claim 27, further comprising detecting, by at least one of the first and second electrodes, electrical signals from the patient'"'"'s body.

33. The method of claim 27, further comprising adjusting the energization of the first and second electrodes by adjusting at least one of:

direction, strength, frequency, and oscillating pattern of the electromagnetic field.

34. The method of claim 27, further comprising adjusting the energization of the first and second electrodes by adjusting at least one of:

duration of energization;

sequence of energization of the electrodes; and

power level of the energization.

35. The method of claim 27, further comprising securing at least a portion of the first and second leads within the patient'"'"'s body.

36. The method of claim 27, wherein the first and second electrodes are coupled to a controller for energizing the first and second electrodes.

37. The method of claim 36, wherein sequentially energizing first and second electrodes comprises:

energizing, by the controller, the first electrode; and

energizing, by the first electrode, the second electrode.

38. A system used for a nerve regeneration treatment, comprising:

a first elongated lead configured to be implanted within a patient'"'"'s body and having a first electrode;

a second elongated lead configured to be implanted within the patient'"'"'s body and having a second electrode; and

a controller configured to sequentially energize the first and second electrodes to create an oscillating electromagnetic field between the electrodes.

39. The system of claim 38, wherein the controller is configured to energize only the first electrode, and the first electrode is configured to transmit electric energy to the second electrode.

40. The system of claim 39, wherein the controller is configured to designate the first electrode from a plurality of electrodes.

41. The system of claim 38, wherein the controller controls at least one of:

direction, strength, frequency, and oscillating pattern of the electromagnetic field.

42. The system of claim 38, wherein the controller controls at least one of:

duration of the energization;

sequence of the energization between electrodes; and

power level of the energization.

45. The system of claim 38, wherein at least one of the plurality of electrodes is configured to monitor the patient'"'"'s response to the oscillating electromagnetic field.

46. The system of claim 38, wherein the controller is configured to modify at least one parameter associated with the first and second electrodes to modify the oscillating electromagnetic field applied to the patient'"'"'s body.

47. The system of claim 38, wherein at least one of the first and second electrodes is configured to detect electrical signals from the patient'"'"'s body.

43-44. -44. (canceled)

48. (canceled)

49. A method for treating a body comprising:

implanting at least a portion of an elongated lead in a patient'"'"'s body, a distal end of the elongated lead comprising an anchoring device;

securing, by the anchoring device, the distal end of the elongated lead to a portion of a patient'"'"'s body.

53. The method of claim 49, wherein the elongated lead comprises at least one of an electrode, a transducer, and a sensor located proximate to the anchoring device.

54. The method of claim 53, wherein the anchoring device comprises the electrode and the transducer.

55. The method of claim 54, wherein the at least one of the electrode and the transducer is integrally formed with the anchoring device.

50-51. -51. (canceled)

56-57. -57. (canceled)

58. A nerve generation system, comprising:

a controller housing;

an elongated lead extending from the housing, at least a portion of the elongated lead being configured to be implanted within a patient'"'"'s body; and

an anchoring device located at a distal end of the elongated lead, the anchoring device being configured to secure the distal end of the elongated lead to a portion of the patient'"'"'s body.

59. The system of claim 58, further comprising at least one of an electrode, a transducer, and a sensor located proximate the anchoring device.

61. The system of claim 59, wherein the at least one of the electrode and the transducer is integrally formed with the anchoring device.

60. (canceled)

62-64. -64. (canceled)

66. A method for treating a body comprising:

implanting at least a portion of an elongated lead in a patient'"'"'s body, the elongated lead having at least one of an electrode and a transducer disposed thereon, wherein the elongated lead is moveably coupled to a controller housing that includes a driver assembly; and

causing a driver assembly to move the elongated lead relative to the controller housing.

68. The method of claim 66, further comprising determining a location of a damaged nerve.

69. The method of claim 68, further comprising causing the driver assembly to extend the elongated lead proximate the damaged nerve.

70. The method of claim 69, further comprising delivering a nerve regeneration treatment to the damaged nerve.

71. The method of claim 70, wherein the elongated lead includes at least one electrode, the method further comprising energizing the electrode to deliver a therapeutic electric signal to the damaged nerve.

72. The method of claim 70, wherein the elongated lead includes a plurality of electrodes, the method further comprising sequentially energizing the plurality of electrodes to create an oscillating electromagnetic field between the electrodes.

67. (canceled)

73. A nerve generation system, comprising:

a controller housing;

an elongated lead movably coupled to the housing, at least a portion of the elongated lead being configured to be implanted within a patient'"'"'s body; and

at least one of an electrode and a transducer coupled to the elongated lead,

wherein the controller housing comprises a driver assembly configured to move the elongated lead relative to the controller housing.

74-77. -77. (canceled)

78. A method for treating a body comprising:

implanting a first wireless electrode device in a patient'"'"'s body proximate a damaged nerve;

implanting a second wireless electrode device that is different in configuration from the first wireless electrode device;

causing at least one of the first and second wireless electrode devices to administer a nerve regeneration treatment to the damaged nerve; and

providing data indicative of the patient response to an external controller.

79. The method of claim 78, further including storing the patient data in a memory module associated with at least one of the first and second wireless electrode devices.

80. The method of claim 78, further comprising implanting a second wireless device within the patient'"'"'s body, the second wireless electrode device configured to communicate wirelessly with at least one of the wireless electrode device and the external controller.

81. The method of claim 80, further comprising sequentially energizing the first wireless electrode device and the second wireless electrode device to create an oscillating electromagnetic field between the electrodes.

82. The method of claim 78, further comprising modifying at least one parameter of the nerve regeneration treatment based on the patient response.

83. The method of claim 78, wherein causing at least one of the first and second wireless electrode devices to administer a nerve regeneration treatment comprises causing the wireless electrode device to deliver a therapeutic electric signal to the damaged nerve.

84. The method of claim 78, wherein causing at least one of the first and second wireless electrode devices to administer a nerve regeneration treatment comprises causing the wireless electrode device to deliver a therapeutic fluid to the damaged nerve.

85. The method of claim 78, wherein at least one of the first and second wireless electrode devices includes at least one sensor.

86. The method of claim 78, further including detecting the patient response to the nerve regeneration treatment.

87. The method of claim 86, further comprising delivering a tagging agent proximate the damaged nerve.

88. The method of claim 87, further comprising measuring a growth of the damaged nerve by monitoring a position of the tagging agent over time.

89. A nerve regeneration system comprising:

a wireless electrode device implanted within a patient'"'"'s body proximate a damaged nerve, the electrode device being configured to administer a nerve regeneration treatment to the damaged nerve and to detect a patient response to the nerve regeneration treatment; and

a controller located external to the patient'"'"'s body and configured to wirelessly communicate with the electrode device.

90. The system of claim 89, further including a second wireless electrode device that differs in configuration with the wireless electrode device.

91. The system of claim 89, further comprising one or more second wireless electrode devices implanted within the patient'"'"'s body and configured to wirelessly communicate with the controller.

92. The system of claim 91, wherein one or more of the second wireless electrode devices is configured to receive patient data from the wireless electrode device.

93. The system of claim 89, wherein the electrode device is configured to modify at least one parameter of the nerve regeneration treatment based on the detected patient response.

94. The system of claim 93, wherein the electrode device is configured to transmit the detected patient response to the controller, and the controller is configured to transmit a controlling signal to the electrode device to modify the at least one parameter based on the detected patient response.

95. The system of claim 89, wherein the electrode device is configured to provide an electric current to one or more additional electrode device.

96. The system of claim 89, wherein the controller comprises at least one of:

a wireless communication device, a personal data assistant (PDA), and a wireless telephone.

97. The system of claim 89, wherein the electrode device comprises a fluid delivery system.

98. The system of claim 97, wherein the fluid delivery system is configured to deliver a therapeutic fluid to the damaged nerve.

99. The system of claim 89, wherein the electrode device comprises at least one sensor.

100. The system of claim 89, wherein the nerve generation treatment comprises an electric stimulation and the electrode device is configured to deliver an electric stimulation signal to the damaged nerve.

101. A method for treating a body comprising:

implanting an elongated tubular member in a patient'"'"'s body proximate a damaged nerve, the elongated tubular member including a plurality of electrodes; and

energizing at least one of the electrodes to deliver an electric stimulation to a portion of the damaged nerve.

102. The method of claim 101, further comprising sequentially energizing the plurality of electrodes to create an oscillating electromagnetic field therebetween.

103. The method of claim 101, further comprising adjusting a parameter of the at least one of the electrodes to control the delivery of electric stimulation to the portion of the damaged nerve.

104. The method of claim 101, further comprising providing data indicative of the nerve'"'"'s response to a controller coupled to the tubular member.

105. The method of claim 104, further comprising adjusting, by the controller, at least one parameter associated with the delivery of the electric stimulation to the portion of the damaged nerve based on the nerve'"'"'s response.

106. The method of claim 105, wherein the at least one parameter includes one or more of:

a field strength, a field direction, a current, and a voltage of the electric stimulation.

107. The method of claim 105, wherein the at least one parameter includes one or more of:

a number, a sequence, or a combination of electrodes to be energized to deliver the electric stimulation.

108. The method of claim 101, further comprising injecting, by the controller, a therapeutic fluid into the tubular member.

109. The method of claim 101, wherein the tubular member comprises a bioabsorbable material.

110. The method of claim 101, wherein the tubular member includes a therapeutic fluid, the method further comprising delivering a therapeutic fluid to the damaged nerve.

111. The method of claim 110, wherein the therapeutic fluid comprises at least one of:

a nerve growth agent, an anti-infection agent, and a pain reducing agent.

112. The method of claim 101, wherein implanting the tubular member further comprises securing a portion of the tubular member to the patient'"'"'s body proximate a damaged nerve.

113. The method of claim 101, wherein the tubular member includes a hollow flexible mesh.

114. The method of claim 101, wherein the tubular member includes a polymeric foam material.

115. The method of claim 101, further comprising monitoring a nerve'"'"'s response to the electric stimulation.

116. A nerve generation system, comprising:

an elongated tubular member configured to be implanted within a patient'"'"'s body proximate a damaged nerve and configured to guide growth of the damaged nerve substantially therethrough; and

a plurality of electrodes disposed along a length of the tubular member,

wherein each of the electrodes is configured to deliver an electric stimulation to a portion of the damaged nerve.

117. The system of claim 116, further comprising a controller configured to communicate with at least one of the plurality of electrodes, wherein the controller is configured to control the delivery of the electric stimulation to the portion of the damaged nerve.

119. The system of claim 117, wherein the controller is in wireless communication with at least one of the plurality of electrodes.

120. The system of claim 117, wherein the controller is configured to provide electric energy to the plurality of electrodes.

121. The system of claim 117, wherein the controller is configured to monitor a signal indicative of the body'"'"'s response to the delivered electric stimulation and adjust at least one parameter associated with the delivery of the electric stimulation based on the monitored signal.

122. The system of claim 121, wherein the at least one parameter comprises one or more of:

a field strength, a field direction, a current, and a voltage of the electric stimulation.

123. The system of claim 121, wherein the at least one parameter comprises one or more of:

a number, a sequence, or a combination of electrodes to be used for the electric stimulation.

124. The system of claim 117, wherein the controller comprises a fluid delivery device for injecting a therapeutic fluid into the tubular member.

125. The system of claim 124, wherein the controller is configured to adjust a delivery parameter associated with the delivery of the therapeutic fluid.

126. The system of claim 125, wherein the delivery parameter comprises one or more of a schedule, rate, or dosage of the therapeutic fluid.

127. The system of claim 116, wherein the plurality of electrodes comprises at least two electrodes each positioned at a proximal end and a distal end, respectively, of the tubular member.

128. The system of claim 116, wherein the tubular member comprises a bioabsorbable material.

129. The system of claim 116, wherein the tubular member is configured to deliver a therapeutic fluid to a portion of the damaged nerve.

130. The system of claim 129, wherein the therapeutic fluid is deposited in the tubular member configured to be released over time.

131. The system of claim 130, wherein the therapeutic fluid is coated at least partially on a surface of the tubular member.

132. The system of claim 129, wherein the therapeutic fluid comprises at least one of:

a nerve growth agent;

an anti-infection agent; and

a pain reducing agent.

133. The system of claim 116, wherein the tubular member comprises a hollow flexible mesh structure.

134. The system of claim 116, wherein the tubular member comprises a polymeric foam material.

135. The system of claim 117, wherein the electrode is further configured to monitor the nerve'"'"'s response to the electric stimulation.

118. (canceled)

136. A tissue manipulating device comprising:

a housing implanted in the body of a patient proximate a damaged nerve; and

an advanceable member at least partially disposed within the housing, the advanceable member being configured to advance from the housing to manipulate nerve tissue proximate the damaged nerve.

137. The device of claim 136, wherein the advanceable member comprises at least one projecting element.

138. The device of claim 137, wherein the at least one projecting element is operatively coupled to a drive member, the drive member being configured to extend the projecting element from the housing.

139. The device of claim 138, further comprising a controller disposed within the housing, the controller being configured to operate the drive member.

140. The device of claim 139, wherein the controller is configured to pulse the drive member to sequentially extend and retract the projecting element, thereby massaging nerve tissue proximate the damaged nerve.

141. The device of claim 139, wherein the controller is communicatively coupled to an external diagnostic tool.

142. The device of claim 139, therein the external diagnostic tool is configured to provide a command signal to the controller, wherein the command signal causes the controller to operate the drive member.

143. The device of claim 142, further including a sensor in data communication with the controller, the sensor being configured to monitor a nerve'"'"'s response to the stimulation.

144. The device of claim 143, wherein the controller is further configured to provide data indicative of the nerve'"'"'s response to the external diagnostic tool.

145. A tissue manipulating system comprising:

a sealed housing configured to be at least partially implanted within a body proximate a damaged nerve;

a fluid port in the sealed housing for receiving fluid;

an inflatable member in fluid communication with the fluid port; and

a controller configured to control flow of the fluid into and out of the inflatable member, thereby controlling inflation and deflation of the inflatable member.

146. The system of claim 145, wherein the inflatable member comprises a balloon.

147. The system of claim 145, wherein the controller comprises a syringe, and injecting the fluid through the syringe causes inflation of the inflatable member.

150. The system of claim 145, further comprising a reservoir configured to store the fluid injected into the fluid port.

148. (canceled)

149. The system of claim 148, wherein the controller is configured to receive command signals from an external device.

151. A method for treating a body comprising:

implanting a housing proximate a damaged nerve, the housing having at least one advanceable member at least partially disposed therein;

sequentially actuating the at least one advanceable member to stimulate the damaged nerve tissue; and

monitoring the damages nerve'"'"'s response to the stimulation.

152. The method of claim 151, wherein the advanceable member comprises at least one projecting element coupled to a drive member, the method further comprising sequentially actuating the drive member to extend and retract the at least one projecting element into the damaged nerve.

153. The method of claim 151, wherein the advanceable member comprises an inflatable member coupled to a pump, the method further comprising sequentially operating the pump to control flow of the fluid into and out of the inflatable member, thereby controlling inflation and deflation of the inflatable member.

154. The method of claim 151, further comprising adjusting a parameter associated with the sequential actuation of the at least one advanceable member based on the damaged nerve'"'"'s response to the stimulation.

155. The method of claim 154, wherein the parameter comprises at least one of a timing and a speed associated with the sequential actuation of the at least one advanceable member.

156. The method of claim 151, wherein the housing includes an electrode, the method further comprising delivering a therapeutic electric signal to the damaged nerve tissue.

157. The method of claim 151, wherein the housing includes a fluid delivery device, the method further comprising delivering a therapeutic fluid to the damaged nerve tissue.

158. A method for treating a body comprising:

depositing a magnetic therapeutic device proximate damaged nerve tissue, the magnetic therapeutic device comprising at least one electromagnet;

energizing the at least one electromagnet to create a stimulating magnetic field;

directing at least a portion of the magnetic field toward the damaged nerve tissue; and

monitoring the damaged nerve'"'"'s response to the magnetic field.

159. The method of claim 158, wherein the at least one electromagnet includes a plurality of electromagnets, the method further comprising sequentially energizing the at least one electromagnet to create an oscillating magnetic field between the plurality of electromagnets.

160. The method of claim 158, wherein monitoring the damaged nerve'"'"'s response to the magnetic field includes measuring a growth of the damaged nerve.