SYSTEMS AND METHODS FOR PROMOTING NERVE RECOGNITION

• US 20100152812A1
• Filed: 06/27/2007
• Published: 06/17/2010
• Est. Priority Date: 06/27/2006
• Status: Abandoned Application

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Cyberkinetics Neurotechnology Systems
• Inventors: Wery, Shawn D., Hartmann, Jonathan T., Flaherty, J. Christopher, Duda, Jessica L.
• Application Number:
  US12/305,421
• Publication Number:
  US 20100152812A1
• Time in Patent Office: Days
• US Class Current: 607/50
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/205 for promoting a biological process
• 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 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system

Abstract

Various exemplary systems and methods for promoting nerve regeneration are disclosed. In certain exemplary embodiments, a nerve regeneration system may include a lead configured to be placed in a body proximate a damaged nerve, a portion of the lead being configured to stimulate the damaged nerve. The system may also include a control module configured to monitor a signal indicative of the nerve'"'"'s response to the stimulation and adjust a parameter of the stimulation in response to the monitored signal.

Claims

1. A nerve regeneration system comprising:

a lead configured to be placed in a body proximate a damaged nerve, a portion of the lead being configured to stimulate the damaged nerve; and

a control module configured to monitor a signal indicative of the nerve'"'"'s response to the stimulation and adjust a parameter of the stimulation in response to the monitored signal.

2. The system of claim 1, wherein the stimulation comprises a therapeutic electric signal.

3. The system of claim 2, wherein the parameter of the stimulation comprises a parameter associated with the electric signal.

4. The system of claim 3, wherein the parameter comprises one or more of strength, direction, current, or voltage of the electric signal.

5. The system of claim 1, further comprising an electrode coupled to the lead and configured to deliver electric stimulation to the damaged nerve.

6. The system of claim 5, wherein the electrode comprises a plurality of electrodes and the parameter comprises one or more of a number, a sequence, or a combination of electrodes to be energized to deliver electric stimulation.

7. The system of claim 5, further comprising a conductor for connecting the electrode to the control module.

8. The system of claim 1, wherein the control module is enclosed in a substantially sealed housing and the lead extends from the housing.

9. The system of claim 8, wherein multiple leads extend from the housing.

10. The system of claim 8, wherein the control module is configured to communicate with an external device.

11. The system of claim 1, wherein the control module is surgically implanted within the body.

12. The system of claim 1, wherein the control module is partially implanted in the body such that at least a portion of the control module is accessible from outside the body.

13. The system of claim 1, wherein the control module comprises a fluid delivery device configured to provide a therapeutic fluid to the damaged nerve.

14. The system of claim 13, wherein the control module comprises a fluid port for supplying fluid to the fluid delivery device.

15. The system of claim 13, wherein the lead is configured to deliver an electrical signal, and the system further comprises a second lead configured to deliver the therapeutic fluid to the damaged nerve.

16. The system of claim 13, wherein the stimulation is delivered by the therapeutic fluid.

17. The system of claim 16, wherein the parameter comprises a delivery parameter associated with the delivery of therapeutic fluid.

18. The system of claim 17, wherein the delivery parameter comprises one or more of a schedule, rate, or dosage of a therapeutic fluid.

19. The system of claim 13, wherein the lead comprises a tube in fluid communication with the fluid delivery device and configured to deliver the therapeutic fluid to the damaged nerve.

20. The system of claim 13, wherein the control module comprises a reservoir in fluid communication with the fluid delivery device for storing a supply of the therapeutic fluid.

21. The system of claim 13, wherein the therapeutic fluid comprises at least one of a nerve growth agent, an anti-infection agent, and a pain reducing agent.

22. The system of claim 1, wherein the lead comprises an expandable member configured to secure the lead proximate the damaged nerve.

23. The system of claim 22, wherein the expandable member comprises an inflatable balloon.

24. The system of claim 23, wherein the control module is configured to control the inflation of the balloon.

25. The system of claim 22, further comprising a fluid delivery device adapted to inflate the inflatable balloon.

26. The system of claim 1, further comprising a sensor coupled to the lead and configured to detect the signal indicative of the nerve'"'"'s response to the stimulation.

27. The system of claim 26, wherein the sensor comprises one or more of:

a physiologic sensor, a cellular sensor, an EEG sensor, an EKG sensor, an EMG sensor, a blood sensor, a glucose sensor, a temperature sensor, a radiation sensor, a magnetic sensor, and a chemical sensor.

28. The system of claim 26, wherein the damaged nerve is a severed nerve having a first end and a second end, and the sensor comprises a first position sensor and a second position sensor, the first position sensor adapted to detect a position of the first end and the second position sensor adapted to detect a position of the second end.

29. The system of claim 28, wherein:

the control module delivers an electromagnetic signal proximate the severed nerve; and

the sensor monitors a reflection of the electromagnetic signal.

30. The system of claim 28, wherein the control module is configured to:

analyze the detected positions of the first and second ends to determine a regeneration rate of the severed nerve; and

modify the parameter based on the regeneration rate of the severed nerve.

31. The system of claim 26, further comprising a transducer coupled to the lead and adapted to deposit a tagging agent proximate the damaged nerve.

32. The system of claim 31, wherein the sensor is configured to detect a growth of the damaged nerve indicative of a change in a position of the tagging agent.

33. The system of claim 31, wherein the sensor is configured to detect a reaction of the tagging agent to an electromagnetic stimulus.

34. The system of claim 31, wherein the tagging agent comprises a fluorescent or luminescent material.

35. The system of claim 31, wherein the tagging agent comprises an RFID device.

36. A nerve regeneration system comprising:

a nerve regeneration module comprising at least one lead implanted in a body proximate a damaged nerve, the nerve regeneration module being configured to;

administer a nerve regeneration treatment to the damaged nerve; and

detect a patient response to the nerve regeneration treatment; and

an interrogator communicatively coupled to the nerve regeneration module and configured to modify a parameter of the nerve regeneration treatment based on the detected patient response.

37. The system of claim 36, wherein the nerve regeneration module is fully implanted in the body of a patient while the interrogator is outside the body.

38. The system of claim 37, wherein the interrogator is configured to modify the parameter of the nerve regeneration treatment after implantation of the nerve regeneration module.

39. The system of claim 36, wherein the interrogator is wirelessly coupled to the nerve regeneration module.

40. The system of claim 36, wherein the interrogator comprises a wireless communication device.

41. The system of claim 40, wherein the interrogator comprises a personal data assistant (PDA) or a wireless telephone.

42. The system of claim 36, wherein the nerve regeneration module is partially implanted in the body of a patient.

43. The system of claim 36, wherein the lead comprises an expandable member configured to secure the lead proximate the damaged nerve.

44. The system of claim 43, wherein the expandable member comprises an inflatable balloon.

45. The system of claim 36, further comprising a protective sheath surrounding the at least one lead.

46. The system of claim 36, further comprising a barb for securing the at least one lead within the body of the patient.

47. The system of claim 46, wherein the barb is retractable.

48. The system of claim 36, wherein the nerve regeneration module comprises a power supply configured to generate an electromagnetic signal for stimulating the damaged nerve.

49. The system of claim 48, wherein the at least one lead comprises one or more electrodes electrically coupled to the power supply, the electrode being configured to deliver the electromagnetic signal to the damaged nerve.

50. The system of claim 49, wherein the one or more of the electrodes are disposed along a length of the at least one lead.

51. The system of claim 36, wherein the nerve regeneration module comprises a fluid delivery system configured to deliver fluid proximate the damaged nerve.

52. The system of claim 51, wherein the fluid delivery system comprises a reservoir for storing fluid associated with the fluid delivery system.

53. The system of claim 51, wherein the fluid comprises a therapeutic fluid and the fluid delivery system is configured to deliver the therapeutic fluid via a fluid delivery tube.

54. The system of claim 53, wherein the fluid delivery tube is routed within the at least one lead.

55. The system of claim 53, wherein the therapeutic fluid comprises a nerve growth agent.

56. The system of claim 51, wherein the fluid delivery system is configured to supply inflating fluid to an expandable member coupled to the at least one lead.

57. The system of claim 51, wherein the fluid delivery system may comprise a syringe associated with the at least one lead.

58. The system of claim 36, wherein the nerve regeneration module comprises a sensor configured to monitor at least one of a biological, physiological, chemical, and electrical conditions associated with the damaged nerve.

59. The system of claim 58, wherein the sensor is coupled to the at least one lead.

60. The system of claim 59, wherein the sensor comprises a chemical sensor adapted to collect data indicative of a hormone level.

61. The system of claim 59, wherein the sensor comprises an electrical signal detector adapted to detect neurological signals associated with the damaged nerve.

62. The system of claim 59, wherein the sensor comprises a heart rate monitor.

63. The system of claim 59, wherein the sensor comprises a temperature sensor.

64. The system of claim 36, further comprising a transducer communicatively coupled to the nerve regeneration module and configured to administer a diagnostic test when prompted by at least one of the nerve regeneration module and the interrogator.

65. The system of claim 64, wherein the transducer comprises an external diagnostic tool adapted to administer a sensory test to a portion of the body.

66. The system of claim 65, wherein the sensory test comprises a pin-prick test.

67. The system of claim 65, wherein the sensory test comprises a light-touch test.

68. The system of claim 64, wherein the transducer is configured to deploy a tagging agent proximate damaged nerves.

69. The system of claim 68, wherein the tagging agent comprises a frequency-responsive dying agent.

70. The system of claim 69, wherein the transducer is further configured to deliver an electrical signal at an appropriate frequency to activate the frequency-responsive dying agent.

71. The system of claim 36, wherein the nerve regeneration treatment comprises transmitting an electromagnetic signal to the damaged nerve to stimulate the damaged nerve.

72. The system of claim 71, wherein the parameter comprises at least one of a power level, a frequency, a field strength, and field direction associated with the electromagnetic signal.

73. The system of claim 36, wherein the nerve regeneration treatment comprises delivering a therapeutic fluid proximate the damaged nerve.

74. The system of claim 73, wherein the parameter comprises at least one of a dosage and a schedule associated with the therapeutic fluid delivery.

75. A method for regenerating a damaged nerve comprising:

providing a therapeutic stimulation to a damaged nerve;

monitoring a signal indicative of the nerve'"'"'s response to the stimulation; and

adjusting a stimulation parameter in response to the monitored signal.

76. The method of claim 75, wherein the providing, the monitoring, and the adjusting are performed by an integrated device.

77. The method of claim 75, wherein providing the therapeutic stimulation comprises:

implanting a stimulation device within a body; and

adjusting the stimulation parameter after implantation.

78. The method of claim 77, wherein the stimulation device comprises a control module having a substantially sealed housing with a lead extending from the housing.

79. The method of claim 78, further comprising fixing the lead in the body of a patient proximate to the damaged nerve.

80. The method of claim 78, further comprising providing the signal to an external diagnostic device.

81. The method of claim 78, wherein adjusting the stimulation parameter comprises automatically adjusting the stimulation parameter based on the monitored signal.

82. The method of claim 78, wherein adjusting the stimulation parameter comprises manually adjusting the stimulation parameter based on the monitored signal.

83. The method of claim 78, wherein adjusting the stimulation parameter comprises:

comparing the monitored signal with a predetermined threshold value;

displaying results of the comparison on a display of the external device; and

receiving a user command for adjusting the stimulation parameter.

84. The method of claim 78, wherein adjusting the stimulation parameter comprises:

comparing the monitored signal with a predetermined threshold value; and

performing a predetermined adjustment routine if the monitored signal exceeds an acceptable deviation limit from the predetermined threshold value.

85. The method of claim 75, wherein providing a therapeutic stimulation comprises delivering an electromagnetic signal to the damaged nerve.

86. The method of claim 85, wherein adjusting a stimulation parameter comprises adjusting at least one of a power level, a frequency, a field strength, and a field direction associated with the electromagnetic signal.

87. The method of claim 75, wherein providing a therapeutic stimulation comprises delivering a therapeutic fluid to the damaged nerve.

88. The method of claim 87, wherein adjusting a stimulation parameter comprises adjusting a dosage of the therapeutic fluid.

89. The method of claim 88, wherein adjusting a stimulation parameter comprises adjusting a schedule for administering the therapeutic fluid.

90. The method of claim 85, wherein the therapeutic fluid comprises a nerve growth agent.

91. The method of claim 75, wherein providing a therapeutic stimulation comprises providing a combination of electromagnetic stimulation and chemical nerve treatment therapy to the damaged nerve.

92. The method of claim 75, wherein providing a therapeutic stimulation comprises providing a combination of electromagnetic stimulation and stem cell nerve treatment therapy to the damaged nerve.

93. The method of claim 75, wherein monitoring a signal comprises monitoring an electric signal emitted by the damaged nerve in response to the therapeutic stimulation.

94. The method of claim 75, wherein monitoring a signal comprises monitoring a hormone level of nerve tissue surrounding the damaged nerve.

95. The method of claim 75, wherein monitoring a signal comprises:

providing an electrical test signal to the damaged nerve;

measuring the nerve'"'"'s response to the test signal; and

determining a current location of a portion of the damaged nerve based on the measured response to the test signal.

96. The method of claim 95, wherein monitoring a signal comprises calculating a growth of the nerve as the difference between the current location of the portion of the damaged nerve and a previous location of the portion of the damaged nerve.

97. A method for promoting nerve regeneration comprising:

administering a nerve regeneration treatment to a damaged nerve;

monitoring a growth associated with the damaged nerve;

comparing the monitored growth with a predetermined value; and

determining whether to adjust a nerve regeneration treatment based on the comparison of the monitored growth with the predetermined value.

98. The method of claim 97, wherein determining whether to adjust the nerve regeneration treatment comprises:

modifying a nerve regeneration treatment parameter if the monitored growth is less than the predetermined value; and

maintaining the nerve regenerating treatment if the monitored growth is greater than the predetermined value.

99. The method of claim 98, wherein administering the nerve regeneration treatment comprises providing an electromagnetic signal for electrically stimulating the damaged nerve.

100. The method of claim 99, wherein modifying the nerve regeneration treatment parameter comprises adjusting at least one of a power level, frequency, field strength, and field direction associated with the electromagnetic signal.

101. The method of claim 98, wherein administering the nerve regeneration treatment comprises delivering a therapeutic fluid to the damaged nerve.

102. The method of claim 101, wherein modifying a nerve regeneration treatment parameter comprises adjusting a dosage associated with the therapeutic fluid.

103. The method of claim 101, wherein modifying a nerve regeneration treatment parameter comprises adjusting a schedule for administering the therapeutic fluid.

104. The method of claim 97, wherein monitoring the growth associated with one or more damaged nerves comprises:

delivering an electromagnetic test pulse to the damaged nerve;

detecting a neurological response from the damaged nerve in response to the test pulse; and

estimating the growth based on the detected neurological response from the damaged nerve.

105. The method of claim 104, wherein estimating the growth comprises comparing the detected neurological response data with previously detected neurological response data.

106. The method of claim 97, wherein monitoring the growth comprises:

providing a first electromagnetic test signal from a first location relative to the damaged nerve;

providing a second electromagnetic test signal from a second location relative to the damaged nerve;

determining a position of an end of a damaged nerve based on the difference between the first electromagnetic test signal and the second electromagnetic test signal; and

comparing the position of the end of the damaged nerve with a previous position of the end of the damaged nerve to determine the growth of the damaged nerve.

107. A nerve regeneration system comprising:

at least one lead implanted in a body proximate a damaged nerve, and

a control module connected to the at least one lead, wherein the control module is configured to;

administer a nerve regeneration treatment to the damaged nerve through the lead;

monitor the growth associated with the damaged nerve; and

determine whether to adjust a nerve regeneration treatment parameter based on the comparison of the monitored growth with the predetermined value.

108. The system of claim 107, wherein the nerve regeneration treatment comprises a therapeutic electric signal.

109. The system of claim 108, wherein the nerve regeneration treatment parameter comprises a parameter associated with the electric signal.

110. The system of claim 109, wherein the parameter comprises one or more of strength, direction, current, and voltage of the electric signal.

111. The system of claim 107, further comprising an electrode coupled to the lead and configured to deliver electric nerve regeneration treatment to the damaged nerve.

112. The system of claim 111, wherein the electrode comprises a plurality of electrodes and the parameter comprises one or more of a number, a sequence, and a combination of electrodes to be energized to deliver electric nerve regeneration treatment.

113. The system of claim 111, further comprising a conductor for connecting the electrode to the control module.

114. The system of claim 107, wherein the control module is enclosed in a substantially sealed housing and the lead extends from the housing.

115. The system of claim 114, wherein multiple leads extend from the control module.

116. The system of claim 114, wherein the control module is configured to communicate with an external device.

117. The system of claim 107, wherein the control module is surgically implanted within the body.

118. The system of claim 107, wherein the control module is partially implanted in the body such that at least a portion of the control module is accessible from outside the body.

119. The system of claim 107, wherein the control module comprises a fluid delivery device configured to provide a therapeutic fluid to the damaged nerve.

120. The system of claim 119, wherein the control module comprises a fluid port for supplying fluid to the fluid delivery device.

121. The system of claim 119, wherein the lead is configured to deliver an electrical signal, and the system further comprises a second lead configured to deliver the therapeutic fluid to the damaged nerve.

122. The system of claim 119, wherein the stimulation is delivered by the therapeutic fluid.

123. The system of claim 122, wherein the parameter comprises a delivery parameter associated with the delivery of therapeutic fluid.

124. The system of claim 123, wherein the delivery parameter comprises one or more of a schedule, rate, or dosage of a therapeutic fluid.

125. The system of claim 119, wherein the lead comprises a tube in fluid communication with the fluid delivery device and configured deliver the therapeutic fluid to the damaged nerve.

126. The system of claim 119, wherein the control module comprises a reservoir in fluid communication with the fluid delivery device for storing a supply of the therapeutic fluid.

127. The system of claim 119, wherein the therapeutic fluid comprises at least one of a nerve growth agent, an anti-infection agent, and a pain reducing agent.

128. The system of claim 107, wherein the lead comprises an expandable member configured to secure the lead proximate the damaged nerve.

129. The system of claim 128, wherein the expandable member comprises an inflatable balloon.

130. The system of claim 129, wherein the control module is configured to control the inflation of the balloon.

131. The system of claim 128, further comprising a fluid delivery device adapted to inflate the inflatable balloon.

132. The system of claim 107, further comprising a sensor coupled to the lead and configured to detect the signal indicative of the nerve'"'"'s response to the stimulation.

133. The system of claim 132, wherein the sensor comprises one or more of:

a physiologic sensor, a cellular sensor, an EEG sensor, an EKG sensor, an EMG sensor, a blood sensor, a glucose sensor, a temperature sensor, a radiation sensor, a magnetic sensor, and a chemical sensor.

134. The system of claim 132, wherein the damaged nerve is a severed nerve having a first end and a second end, and the sensor comprises a first position sensor and a second position sensor, the first position sensor adapted to detect a position of the first end and the second position sensor adapted to detect a position of the second end.

135. The system of claim 134, wherein:

the control module delivers an electromagnetic signal proximate the severed nerve; and

the sensor monitors a reflection of the electromagnetic signal.

136. The system of claim 134, wherein the control module is configured to:

analyze the detected positions of the first and second ends to determine a regeneration rate of the severed nerve; and

modify the parameter based on the regeneration rate of the severed nerve.

137. The system of claim 132, further comprising a transducer coupled to the lead and adapted to deposit a tagging agent proximate the damaged nerve.

138. The system of claim 137, wherein the sensor is configured to detect a growth of the damaged nerve indicative of a change in a position of the tagging agent.

139. The system of claim 137, wherein the sensor is configured to detect a reaction of the tagging agent to an electromagnetic stimulus.

140. The system of claim 137, wherein the tagging agent comprises a fluorescent or luminescent material.

141. The system of claim 137, wherein the tagging agent comprises an RFID device.

142. A device for administering a neurological test to a portion of a patient'"'"'s body comprising:

a probe;

a drive assembly configured to move the probe relative to a patient'"'"'s body; and

a controller configured control the operation of the drive assembly to bring at least a portion of the probe in contact with the patient'"'"'s body and to provide physical stimulation to the portion of the patient'"'"'s body in accordance with a predetermined test parameter.

143. The device of claim 142, wherein the probe comprises a pin for pricking the skin of the patient.

144. The device of claim 143, wherein the drive assembly comprises a linear drive device for extending and retracting the pin from the skin of the patient.

145. The device of claim 142, wherein the controller is communicatively coupled to an external diagnostic device and configured to control the operation of the drive assembly in response to command signals from the external diagnostic device.

146. The device of claim 142, wherein the probe includes a rotatable member configured to rub the skin of the patient.

147. The device of claim 142, wherein the predetermined test parameter includes at least one of:

a force applied by the drive assembly, an amount of pressure applied by the probe to the patient'"'"'s body, an amount of movement of the probe relative to the patient'"'"'s body, a duration of operation of the drive assembly, and a range of motion associated with the drive assembly.

148. The device of claim 142, further comprising a fixing member configured to fix the device relative to the patient'"'"'s body.

149. The device of claim 148, wherein the fixing member comprises a band configured to wrap around a portion of the patient'"'"'s body.

150. A method for administering a neurological test to a patient'"'"'s body comprising:

establishing at least one test parameter for administering a neurological test to the skin of the patient;

stimulating a surface of the patient'"'"'s skin according to the at least one test parameter; and

monitoring the patient'"'"'s response to the stimulation.

151. The device of claim 150, wherein the at least one test parameter includes at least one of:

a force applied by the drive assembly, an amount of pressure applied by the probe to the patient'"'"'s body, an amount of movement of the probe relative to the patient'"'"'s body, a duration of operation of the drive assembly, and a range of motion associated with the drive assembly.