Medical device insertion system and related methods

• US 20070156126A1
• Filed: 12/29/2005
• Published: 07/05/2007
• Est. Priority Date: 12/29/2005
• Status: Abandoned Application

• Current Assignee: Braingate Co., LLC
• Original Assignee: Braingate Co., LLC
• Inventors: Flaherty, J.
• Application Number:
  US11/319,547
• Publication Number:
  US 20070156126A1
• Time in Patent Office: Days
• US Class Current: 606/32
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/1077 Measuring of profiles
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

Various embodiments of an insertion system for inserting a medical implant and related methods are disclosed. In one embodiment, an insertion system used to insert an implant into a patient'"'"'s body may include a housing and a movable member configured to move relative to the housing. The system may further include an alignment detection mechanism disposed adjacent the housing and configured to detect an alignment information of the movable member with respect to at least one of the implant and a target site of the patient'"'"'s body.

Claims

1. An insertion system used to insert an implant into a patient'"'"'s body, comprising:

a housing;

a movable member configured to move relative to the housing; and

an alignment detection mechanism disposed adjacent the housing and configured to detect an alignment information of the moveable member with respect to at least one of the implant and a target site of the patient'"'"'s body.

2. The system of claim 1, wherein the housing defines an internal space and the movable member is disposed at least partially in the internal space.

3. The system of claim 2, wherein the internal space extends along a longitudinal axis and the movable member is movable along the longitudinal axis.

4. The system of claim 1, wherein the housing comprises an operator grip configured such that, when an operator grips the operator grip, the housing aligns in a particular orientation.

5. The system of claim 1, further comprising the implant, wherein the implant comprises at least one projection penetrating into a surface of the target site.

6. The system of claim 1, further comprising the implant, wherein the implant comprises an electrode sensor for detecting or transmitting electrical signals to or from the patient'"'"'s body.

7. The system of claim 6, wherein the electrode sensor comprises a multi-electrode array having a plurality of electrodes.

8. The system of claim 6, wherein the implant is configured to be placed in the patient'"'"'s brain.

9. The system of claim 1, further comprising the implant, wherein the implant includes a sensor or transducer selected from the group consisting of:

a recording electrode;

a stimulating electrode;

a photo sensor;

a temperature sensor;

a pressure sensor;

an acoustic transducer;

a physiologic sensor;

a light transducer;

a heat transducer;

a magnetic transducer; and

any combination thereof.

10. The system of claim 1, wherein the alignment detection mechanism detects the alignment information of the movable member with respect to both the implant and the target site.

11. The system of claim 1, wherein the alignment detection mechanism is configured to detect an alignment information of the implant and the target site.

12. The system of claim 1, wherein the alignment detection mechanism is configured to detect topography of the target site.

13. The system of claim 1, wherein the alignment detection mechanism is integrally formed with the housing.

14. The system of claim 1, wherein the alignment detection mechanism comprises at least one of a photodetector and a phototransmitter.

15. The system of claim 14, wherein the alignment detection mechanism comprises at least two photodetectors or phototransmitters arranged substantially symmetrically with respect to the movable member.

16. The system of claim 1, wherein the alignment detection mechanism comprises a radar.

17. The system of claim 1, wherein the alignment detection mechanism comprises an imaging device.

18. The system of claim 17, wherein the imaging device comprises a camera.

19. The system of claim 17, wherein the imaging device comprises a sound or ultrasound imaging device.

20. The system of claim 1, further comprising an alignment indicator configured to indicate the alignment information.

21. The system of claim 20, wherein the alignment indicator is fixed to the housing.

22. The system of claim 20, wherein the alignment indicator comprises a signal light.

23. The system of claim 20, wherein the alignment indicator comprises a display screen.

24. The system of claim 1, wherein the alignment information comprises angular orientation of the movable member with respect to the target site.

25. The system of claim 1, wherein the alignment information comprises a distance between the movable member and the target site.

26. The system of claim 1, wherein the alignment information comprises a confirmation whether the movable member is in a desired position with respect to the target site.

27. The system of claim 26, wherein the desired position is input by an operator.

28. The system of claim 1, wherein the alignment information is provided in quantitative form.

29. The system of claim 1, wherein the alignment information is provided and adjusted continuously.

30. The system of claim 29, wherein the alignment information provided is indicative of the movable member being in a desired position.

31. The system of claim 30, wherein the desired position is determined based on information provided by an operator.

32. The system of claim 1, wherein the movable member moves in a non-linear acceleration profile during insertion of the implant.

33. The system of claim 32, wherein the acceleration profile comprises an initial acceleration during a predetermined period followed by a deceleration before the movable member stops.

34. The system of claim 1, wherein the movable member is configured to hold the implant.

35. The system of claim 34, wherein the movable member comprises an opening in fluid communication with a suction source for holding the implant.

36. The system of claim 34, wherein the movable member holds the implant with one or more of:

a vacuum;

a magnetic force; and

a mechanical grasper.

37. The system of claim 1, further comprising a motion detector for detecting movement of the target site.

38. The system of claim 1, further comprising an electrocardiogram sensor for monitoring the patient'"'"'s heart beat.

39. The system of claim 1, further comprising a respiration sensor for monitoring the patient'"'"'s respiration pattern.

40. The system of claim 1, further comprising a frame for supporting the housing.

41. The system of claim 40, wherein the frame comprises a stereotactic frame.

42. The system of claim 40, wherein the frame comprises a movement controller configured to control a movement of the housing relative to the target site.

43. The system of claim 42, wherein the movement controller is configured to receive a control signal from an operator for controlling the movement of the housing.

44. The system of claim 42, wherein the movement controller is configured to receive a control signal from the alignment detection mechanism for controlling the movement of the housing.

45. The system of claim 1, further comprising an actuation switch for actuating insertion of the implant.

46. The system of claim 1, further comprising an electronic module configured to process the alignment information detected by the alignment detection mechanism.

47. The system of claim 46, further comprising an alignment indicator configured to indicate the alignment information, wherein the electronic module is configured to transmit the alignment information to the alignment indicator.

48. The system of claim 46, wherein the electronic module is configured to transmit the alignment information to an external device.

49. The system of claim 46, wherein the electronic module is configured to generate a control signal for movement of the housing.

50. The system of claim 46, wherein the electronic module is configured to receive input information comprising a desired insertion position of the implant relative to the target site.

51. The system of claim 50, further comprising an alignment indicator configured to indicate the alignment information, wherein the electronic module is configured to compare the alignment information with the input information and transmit a compared result to the alignment indicator.

52. The system of claim 50, further comprising an input device configured to input the input information to the electronic module.

53. The system of claim 50, wherein the electronic module is configured to connect to an external device for receiving the input information from the external device.

54. The system of claim 50, wherein the electronic module is configured to generate a control signal for adjusting a position of the implant relative to the target site according to the input information.

55. The system of claim 50, wherein the input information comprises a distance between a surface of the implant and the target site.

56. The system of claim 50, wherein the input information comprises an acceleration profile of the movable member during insertion of the implant.

57. The system of claim 50, wherein the input information comprises an orientation of the implant relative to the target site.

58. The system of claim 50, wherein the input information comprises a force exerted by the movable member onto the target site during insertion of the implant.

59. The system of claim 50, wherein the input information comprises a depth of penetration of the implant relative to a surface of the target tissue.

60. The system of claim 46, wherein the electronic module is configured to control the movement of the movable member relative to the housing.

61. The system of claim 46, further comprising a motion detector for detecting a motion of the target site, wherein the electronic module is configured to analyze the detected motion of the target site so as to determine a timing for insertion of the implant.

62. The system of claim 46, further comprising an electrocardiogram sensor for monitoring the patient'"'"'s heart beat so as to determine motion of the target site, wherein the electronic module is configured to analyze the detected motion of the target site so as to determine a timing for insertion of the implant.

63. The system of claim 46, further comprising a respiration sensor for monitoring the patient'"'"'s respiration pattern so as to determine motion of the target site, wherein the electronic module is configured to analyze the detected motion of the target site so as to determine a timing for insertion of the implant.

64. The system of claim 1, further comprising a linear drive mechanism for driving the movable member relative to the housing so as to insert the implant in the patient'"'"'s body.

65. The system of claim 64, wherein the linear drive mechanism is controlled by an electronic module.

66. The system of claim 64, wherein the linear drive mechanism comprises an electromagnetic drive mechanism.

67. The system of claim 64, wherein the linear drive mechanism comprises at least one of:

a pneumatic drive assembly;

a spring-driven assembly;

a motor-driven assembly;

a hydraulic drive assembly; and

a magnetic drive assembly.

68. The system of claim 1, further comprising a position indicator for indicating a position of the movable member relative to the target site.

69. The system of claim 1, further comprising a force measurement sensor for detecting contact force against the implant during insertion.

70. An insertion system used to insert an implant into a patient'"'"'s body, comprising:

a housing;

a movable member configured to move relative to the housing;

at least one sensor configured to detect a characteristic of a target site, the characteristic including at least one of;

an alignment status of the implant relative to the target site;

a motion of the target site;

the patient'"'"'s heart beat;

the patient'"'"'s blood pressure; and

the patient'"'"'s respiration pattern; and

an electronic module configured to analyze the characteristic of the target site so as to determine a timing for insertion of the implant.

71. The system of claim 70, wherein the housing defines an internal space and the movable member is disposed at least partially in the internal space.

72. The system of claim 71, wherein the internal space extends along a longitudinal axis and the movable member is movable along the longitudinal axis.

73. The system of claim 70, further comprising the implant, wherein the implant comprises at least one projection penetrating into a surface of the target site.

74. The system of claim 70, further comprising the implant, wherein the implant comprises an electrode sensor for detecting or transmitting electrical signals from or to the patient'"'"'s body.

75. The system of claim 70, wherein the at least one sensor comprises a motion detector for detecting the motion of the target site.

76. The system of claim 70, wherein the at least one sensor comprises an electrocardiogram sensor for detecting the patient'"'"'s heart beat.

77. The system of claim 70, wherein the at least one sensor comprises a respiration sensor for detecting the patient'"'"'s respiration pattern.

78. The system of claim 70, wherein the at least one sensor comprises an alignment detector for detecting the alignment status of the implant relative to the target site.

79. The system of claim 78, wherein, when the alignment detector confirms proper alignment of the implant relative to the target site, the electronic module is configured to generate a control signal for actuating the movable member to insert the implant during the determined timing.

80. The system of claim 70, wherein the electronic module is configured to transmit the determined timing to an operator.

81. The system of claim 70, further comprising an indicator for indicating the determined timing.

82. The system of claim 70, wherein the electronic module is configured to transmit the determined timing to an external device.

83. The system of claim 70, wherein the electronic module is configured to generate a control signal for actuating the movable member to insert the implant during the determined timing.

84. The system of claim 70, wherein the movable member is configured to hold the implant.

85. A method of inserting an implant into a patient'"'"'s body, comprising:

providing an inserter comprising;

a housing;

a movable member configured to move relative to the housing; and

an alignment detection mechanism disposed adjacent the housing;

placing the inserter near a target surface;

detecting alignment of the movable member relative to the target surface with the alignment detection mechanism; and

upon confirming that the implant is in a desired position, inserting the implant into the patient'"'"'s body by moving the movable member towards the target surface.

86. The method of claim 85, further comprising placing the implant on the movable member.

87. The method of claim 85, further comprising displaying the detected alignment on an indicator.

88. The method of claim 85, wherein detecting alignment comprises detecting topography of the target surface.

89. The method of claim 85, wherein the implant comprises at least one projection penetrating into the target surface.

90. The method of claim 85, wherein the implant comprises an electrode sensor for detecting or transmitting electrical signals from or to the patient'"'"'s body.

91. The method of claim 90, wherein the electrode sensor comprises a multi-electrode array having a plurality of electrodes.

92. The method of claim 85, wherein the target surface comprises a surface of the patient'"'"'s brain.

93. The method of claim 85, wherein detecting alignment comprises detecting a distance between the movable member and the tissue surface.

94. The method of claim 85, further comprising adjusting alignment of the movable member based on the detected alignment of the movable member.

95. The method of claim 94, wherein adjusting alignment is automatically performed based on the detected alignment of the movable member.

96. The method of claim 85, wherein the desired position comprises a bottom surface of the movable member aligned substantially parallel to the target surface.

97. The method of claim 85, wherein the desired position comprises a bottom surface of the movable member aligned at a non-perpendicular angle with respect to the target surface.

98. The method of claim 85, wherein the desired position comprises a bottom surface of the movable member positioned at a predetermined distance from the target surface.

99. The method of claim 85, further comprising detecting a characteristic of the target surface so as to determine a proper timing for insertion of the implant.

100. The method of claim 99, wherein the proper timing comprises a time period in which the target surface remains in a substantially stationary position.

101. The method of claim 99, wherein the proper timing comprises a time period in which the target surface is at a location in closest proximity to the movable member.

102. The method of claim 99, wherein the proper timing comprises a time period in which the target surface is at a location in furthest proximity to the movable member.

103. The method of claim 99, wherein detecting a characteristic of the target surface comprises detecting a motion of the target surface with a motion detector.

104. The method of claim 99, wherein detecting a characteristic of the target surface comprises monitoring the patient'"'"'s heart beat and characterizing the pattern of the heart beat with respect to time.

105. The method of claim 99, wherein detecting a characteristic of the target surface comprises monitoring the patient'"'"'s respiration function and characterizing the pattern of the respiration with respect to time.

106. The method of claim 85, further comprising inputting information to the inserter, the information comprising the desired position of the implant.

107. The method of claim 106, wherein the inserter comprises an electronic module for processing the information.

108. The method of claim 106, wherein the information comprises a force exerted by the movable member onto the implant during insertion.

109. The method of claim 106, wherein the information comprises an acceleration profile of the movable member during insertion.

110. The method of claim 106, wherein the information comprises a depth of penetration of the movable member relative to the target surface.

111. The method of claim 106, wherein the information comprises orientation of the movable member relative to the target surface.

112. The method of claim 106, wherein the information comprises a distance between a bottom surface of the movable member and the target surface.

113. The method of claim 85, further comprising comparing the detected alignment of the movable member to the desired position.

114. The method of claim 85, wherein detecting alignment is performed by a detector comprising a photosensor.

115. The method of claim 85, wherein detecting alignment is performed by an imaging device.

116. The method of claim 85, further comprising attaching the inserter to a frame.

117. The method of claim 116, wherein placing the inserter near the target surface comprises moving the inserter with respect to the frame.

118. The method of claim 116, wherein the frame comprises a movement controller configured to control movement of the inserter relative to the target surface.

119. The method of claim 85, wherein detecting alignment comprises generating a control signal for controlling the movement of the inserter relative to the target surface.

120. The method of claim 85, wherein moving the movable member towards the target surface comprises actuating an actuation switch.

121. The method of claim 85, further comprising transmitting the detected alignment to an external device.

122. The method of claim 85, wherein moving the movable member towards the target surface comprising moving the movable member according to a predetermined acceleration profile.

123. The method of claim 85, further comprising detecting a position of the movable member relative to the target surface.

124. The method of claim 85, further comprising detecting a contact force against the target surface during insertion.

125. A method of inserting an implant into a patient'"'"'s body, comprising:

providing an inserter comprising;

a housing; and

a movable member configured to move relative to the housing;

placing the inserter near a target surface so that the movable member is positioned at a distance from the target surface;

detecting a characteristic of the target surface by monitoring at least one of;

a motion of the target surface;

the patient'"'"'s heart beat;

the patient'"'"'s blood pressure; and

the patient'"'"'s respiration pattern;

analyzing the detected characteristic of the target surface so as to determine a proper timing for insertion of the implant; and

inserting the implant into the patient'"'"'s body during the proper timing by moving the movable member towards the target surface.

126. The method of claim 125, further comprising placing the implant on the movable member.

127. The method of claim 125, wherein the implant comprises at least one projection penetrating into the target surface.

128. The method of claim 125, wherein the implant comprises an electrode sensor for detecting or transmitting electrical signals from or to the patient'"'"'s body.

129. The method of claim 125, wherein the target surface comprises a surface of the patient'"'"'s brain.

130. The method of claim 125, further comprising detecting alignment of the movable member relative to the target surface.

131. The method of claim 130, wherein detecting alignment comprises detecting a distance between the implant and the target surface.

132. The method of claim 130, further comprising, upon confirming proper alignment of the implant relative to the target surface, actuating the movable member to insert the implant during the determined timing.

133. The method of claim 130, further comprising adjusting alignment of the movable member based on the detected alignment of the implant.

134. The method of claim 125, wherein the proper timing comprises a time period in which the target surface remains in a substantially stationary position.

135. The method of claim 125, wherein analyzing the detected characteristic of the target surface comprises characterizing the pattern of the heart beat with respect to time.

136. The method of claim 125, wherein analyzing the detected characteristic of the target surface comprises characterizing the pattern of the respiration with respect to time.

137. The method of claim 125, further comprising, upon determining the proper timing, automatically actuating the movable member so as to insert the implant during the proper timing.

138. The method of claim 125, further comprising transmitting the detected characteristic of the target surface to an external device.

139. The method of claim 125, wherein monitoring the motion of the target surface is performed with a motion detector.

140. The method of claim 125, wherein monitoring the patient'"'"'s heart beat is performed with an electrocardiogram sensor.

141. The method of claim 125, wherein monitoring the patient'"'"'s respiration pattern is performed with a respiration sensor.

142. The method of claim 125, further comprising transmitting the determined timing to an operator or an external device.

143. The method of claim 125, further comprising displaying the determined timing.