Remotely controlled catheter insertion system

• US 20080009791A1
• Filed: 07/11/2006
• Published: 01/10/2008
• Est. Priority Date: 07/11/2005
• Status: Active Grant

• Current Assignee: Catheter Precision, Inc. (Ra Medical Systems Inc.)
• Original Assignee: Catheter Robotics, Inc.
• Inventors: Cohen, Todd, Eilenberg, Michael
• Granted Patent: US 8,202,244 B2
• Time in Patent Office: Days
• US Class Current: 604/095.01
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0133 Tip steering devices

Abstract

A remotely controlled insertion system for a medical device is described. The system comprises a robotic device and a remote control mechanism. The robotic device has a handle controller to receive and hold the control handle or proximal end of a medical device. The medical device is capable of moving in up to six ranges of motion. In ione embodiment a first motor is connected through a drive screw to a handle controller to move the medical device forward and backward. A second motor is connected to drive wheels effective to rotate the medical device clockwise and counter-clockwise. A third motor drives a series of gears that are connected to one or more control members on the medical device, this being effective to deflect a tip of the medical device so that movement of the third motor causes such deflection. A control unit is connected to all three motors.

Claims

1. A system for remotely controlling the positioning within the body of a patient of an elongated medical device having a control handle, the system comprising:

a robotic device configured to position the medical device within the body of the patient; and

a remote control mechanism configured to control the robotic device,

wherein the robotic device comprises a handle controller to receive the control handle.

2. The system of claim 1, wherein the remote control mechanism comprises a remote control station and a robotic device controller, an operator using the remote control station to control the robotic device.

3. The system of claim 2, wherein the remote control mechanism includes one or more transmitters, receivers, and/or transceivers to communicate information between the remote control station and the robotic device controller.

4. The system of claim 1, wherein the robotic device is controlled from a remote control station at a location that is remote from the location of the patient.

5. The system of claim 4, wherein the location of the remote control station is a shielded control room.

6. The system of claim 2, wherein the remote control station comprises a joystick that can be an operated by an operator to control the robotic device.

7. The system of claim 1, wherein the robotic device is further configured to insert the medical device within the body of the patient.

8. The system of claim 1, wherein the handle controller is modular.

9. The system of claim 8, wherein the modular handle controller is designed specifically to control a particular type or model of medical device.

10. The system of claim 8, wherein the modular handle controller is designed specifically to control a particular catheter handle and its controls.

11. The system of claim 8, wherein the modular handle controller is designed specifically to control delivery, positioning, and placement of a pacemaker and/or defibrillator lead.

12. The system of claim 1, wherein the handle controller can be adapted to conform to a variety of different medical devices.

13. The system of claim 1, wherein the medical device is a catheter and the robotic device comprises a catheter control device.

14. The system of claim 13, wherein the handle controller of the robotic device engages the control handle of the catheter.

15. The system of claim 14, wherein the handle controller uses the standard features of the catheter control handle to, within the body of the patient, insert the catheter, steer the catheter, rotate the catheter, place the catheter, shape the catheter, or deflect the catheter, or a combination of two or more thereof.

16. The system of claim 13, wherein the catheter is an electrophysiology catheter.

17. The system of claim 13, wherein the catheter control device is further configured to feed the catheter within the patient'"'"'s circulatory system.

18. The system of claim 13, wherein the catheter is used for a cardiac, vascular, radiological, gastroenterological, or nephrological procedure or a combination of two or more of such procedures.

19. The system of claim 18, wherein the catheter is an interventional catheter used to deliver therapy for the one or more procedures.

20. The system of claim 16, wherein the catheter is used for mapping and catheter ablation.

21. The system of claim 13, wherein the catheter is used for stenting, angioplasty, or drug delivery or a combination of two or more thereof.

22. The system of claim 14, wherein the handle controller further includes a catheter feeder system.

23. The system of claim 22, wherein the handle controller further comprises:

a clamp;

a handle assembly; and

a catheter control assembly.

24. The system of claim 22, wherein the handle controller further comprises:

an outer housing assembly, wherein the outer housing assembly includes an outer ring and one or more gears; and

a clamp assembly effective to clamp the control handle of the medical device to the handle controller, wherein the clamp assembly includes one or more clampbrackets, clamps, or belts.

25. The system of claim 23, wherein the handle assembly includes a handle outer housing assembly comprised of an outer ring and one or more gears.

26. The system of claim 14, wherein the handle controller further comprises:

means for holding said catheter firmly;

means for rotating said catheter; and

means for shaping, deflecting, steering, placing, or positioning the catheter, or a combination of two or more thereof, within the patient.

27. The system of claim 14, wherein the handle controller further includes one or more sensors to communicate information to the remote control device regarding movement of the catheter and the environment of the catheter within the patient'"'"'s body.

28. The system of claim 27, wherein the information is communicated to the remote station.

29. The system of claim 27, wherein the remote control mechanism comprises information regarding manual introduction or manipulation of a catheter into the human body, and the control mechanism can transmit information back and forth to the catheter handle control device and catheter feeder system so as to translate manipulation, performed remotely to the actual invasive system.

30. The system of claim 29, wherein the remote control comprises a computer in which catheter movement and manipulations can be remotely performed by safe iterative steps to safely reach targeted sites for catheter deployment.

31. The system of claim 30, wherein the iterative steps are performed with human oversight.

32. The system of claim 14, wherein the handles, knobs, switches, or controls on a catheter control handle are manipulated by the handle controller to approximate the precise movement and feel of a similar catheter which is inserted and manipulated manually within the human body.

33. The system of claim 1 which is securely affixed to a base or support so that a medical device can be delivered to a patient in a stable, predictable, and secure manner.

34. The system of claim 33 which is mounted to a ceiling, table, wall, floor, tripod, or cart with locking wheels.

35. The system of claim 1, wherein the medical device is a pacemaker and/or defibrillator lead.

36. The system of claim 35, wherein the robotic device can advance and remove the lead and/or rotate the lead clockwise and counter-clockwise.

37. The system of claim 35 which also includes means for securing and/or deploying a lead for pacing or shocking, i.e., cardioverting or defibrillation, within the coronary sinus vein or its branches.

38. The system of claim 36, wherein a lead capable of applying low and/or high voltage therapy to the left atrium or the left ventricle is deployed.

39. The system of claim 1, wherein the medical device is a guidewire or stylette.

40. The system of claim 39, wherein the robotic device can advance and remove the guidewire or stylette and/or rotate the guidewire or stylette clockwise and counter-clockwise.

41. The system of claim 16, wherein the electrophysiology catheter is a mapping and/or ablation catheter.

42. The system of claim 41 which can be used to perform atrial fibrillation ablation.

43. The system of claim 41 which can be used to perform ventricular tachycardia ablation.

44. The system of claim 41 which can be used to perform atrial flutter ablation.

45. The system of claim 41 which can be used to perform atrial tachycardia ablation.

46. The system of claim 41 which can be used to perform pulmonary vein isolation.

47. The system of claim 41, which can be used to perform simple ablations.

48. The system of claim 41 which can be used to perform complex ablations.

49. The system of claim 48 which can be used to perform complex ablations for accessory pathway mediated tachycardias.

50. The system of claim 1 which has limiters to limit the advancement or withdrawal of a medical device.

51. The system of claim 1, wherein the robotic device comprises:

a handle controller effective to receive a control handle of a catheter, the catheter having at least three ranges of motion and a distal end;

a first motor connected to the handle controller and effective to at least move the catheter forward and/or backward;

a second motor connected to the handle controller and effective to at least rotate the catheter;

a third motor connected to the handle controller and effective to at least deflect the distal end in at least a first direction; and

a controller unit connected to the first, second and third motors.

52. The system of claim 51, wherein:

the first motor is connected to an externally threaded drive screw;

the handle controller is connected to an internally threaded drive support; and

the drive screw is mated with the drive support.

53. The system of claim 51, wherein the handle controller is connected to a telescoping rod so that when the catheter control handle is inserted into the handle controller, the distal end of the catheter is inserted into and through the telescoping rod.

54. The system of claim 53, wherein the telescoping rod extends from the handle controller to the catheter feeder.

55. The system of claim 53, wherein the telescoping rod is a collapsible tube with an inner diameter which can easily deliver a medical device such as a catheter or lead without buckling.

56. The system of claim 53, wherein the telescoping rod is constructed of interlocking cylinders such that as the cylinders get closer to the handle controller they get progressively larger.

57. The system of claim 53, wherein the telescoping rod is constructed of interlocking cylinders such that as the cylinders get closer to the handle controller they get progressively smaller.

58. The system of claim 53, wherein the telescoping rod is sterile.

59. The system of claim 53, where in the telescoping rod is disposable.

60. The system of claim 53, where in the telescoping rod is sterilizable.

61. The system of claim 53, wherein the telescoping rod is connected to a catheter feeder, the catheter feeder including a clip effective to inhibit buckling of the sheath.

62. The system of claim 61, wherein a specially designed clip can securely attach the end of the controller to an introducer sheath to maintain a short fixed distance and prevent catheter buckling during remote catheter manipulation.

63. The system of claim 61, wherein the clip is sterile.

64. The system of claim 61, wherein the clip is disposable.

65. The system of claim 61, wherein the clip is sterilizable.

66. The system of claim 51, further comprising a sensor disposed proximate to the first motor, the sensor being effective to detect a movement of the first motor.

67. The system of claim 51, wherein the handle controller further includes a stabilizer bar effective to receive a flexible portion of the catheter.

68. The system of claim 67, wherein the stabilizer bar is effective to mate with the flexible portion in a snap-fit manner.

69. The system of claim 67, further comprising a sensor disposed proximate to the stabilizer bar, the sensor being effective to detect force applied by the distal end of the catheter.

70. The system of claim 69, further comprising a limiter connected to the sensor and effective to limit the first motor.

71. The system of claim 1, wherein the handle controller is detachably mounted to a rotation assembly.

72. The system of claim 71, wherein the handle controller includes a cylinder and the second motor is connected to a drive wheel connected to the cylinder.

73. The system of claim 72, wherein the rotation assembly includes the drive wheel and a driven wheel.

74. The system of claim 73, wherein the rotation assembly further includes a support wheel.

75. The system of claim 74, wherein the support wheel is grooved.

76. The system of claim 71, wherein the handle controller further includes a slip ring.

77. The system of claim 51, further comprising a sensor disposed proximate to the second motor, the sensor being effective to detect a movement and/or force of the second motor.

78. The system of claim 51, wherein the catheter includes at least one control member effective to control deflection of the distal end and the third motor is connected to the at least one control member.

79. The system of claim 78, wherein each control member is a switch, knob, lever, slide, gear, or button.

80. The system of claim 78, wherein the third motor is connected to the at least one control member through at least one gear.

81. The system of claim 80, wherein the third motor is connected to the at least one control member through a first, second and third gear, the third gear including a gear extension defining an opening for placement of the at least one control member.

82. The system of claim 51, further comprising a sensor disposed proximate to the third motor, the sensor effective to detect a movement and or force of the third motor.

83. The system of claim 82, wherein the catheter includes at least one control member effective to control deflection of the distal end and the third motor is connected to the at least one control member.

84. The system of claim 83, wherein each control member is a switch, knob, lever, slide, gear, or button.

85. The system of claim 83, wherein the third motor is connected to the at least one control member through at least one gear.

86. The system of claim 85, wherein the third motor is connected to the at least one control member through a first, second and third gear, the third gear including a gear extension defining an opening for the knob.

87. The system of claim 51, wherein the control unit is connected to the first, second and third motor through the use of wires.

88. The system of claim 51, wherein the control unit is connected to the first, second and third motor wirelessly.

89. The system of claim 51, wherein the control unit includes a separate control for each of the first, second and third motors.

90. The system of claim 1, wherein the robotic device is configured so that any tubing or wires extending into the medical device do not get tangled as the medical device is rotated.

91. The system of claim 90, wherein there is a rotating connector in communication with the proximal end of the medical device.

92. The system of claim 1, wherein the medical device is a commercially available steerable catheter, introducer sheath, pacing or defibrillation lead, guidewire, or stylette.

99. The system of claim 1, wherein the medical device is a commercially available steerable catheter, introducer sheath, pacing or defibrillation lead, guidewire, or stylette.

100. In an improved method of mapping, tracking, or delivering therapy with a medical device in combination with an imaging technique, the improvement wherein a remote positioning control system of claim 1 is used to position the medical device.

101. In an improved method for mapping and catheter ablation by inserting a mapping and ablation catheter into a patient, the improvement wherein a remote positioning control system of claim 1 is used to position the catheter.

102. The method of claim 101, wherein a pacing and/or defibrillation lead is placed, deployed, and/or screwed in.

103. The method of claim 101, wherein a pacing and/or defibrillation lead is remotely delivered to the right atrium, left atrium, right ventricle, or left ventricle.

104. The method of claim 103, wherein the lead is delivered epicardially, endocardially, or via the coronary sinus vein.

93. A method for using a remotely controlled robotic catheter device, the method comprising:

inserting the control handle of a first catheter into a first handle controller;

inserting the first handle controller into the robotic device;

operating the device;

removing the first catheter and the first handle controller;

inserting the control handle of a second catheter into a second handle controller, the second catheter having a structure distinct from the structure of the first catheter;

inserting the second handle controller into the robotic device; and

operating the device.

94. The method of claim 93, wherein the handle controllers are inserted into a rotation assembly.

95. The method of claim 94, wherein the rotation assembly includes a driving wheel, a driven wheel and a support wheel.

96. The method of claim 93, wherein the inserting the control handle of the first catheter into the first handle controller includes inserting the first control handle into a stabilizer bar.

97. The method of claim 93, wherein the inserting the first catheter control handle into the first handle controller includes connecting the first catheter to a motor, the motor effective to impart deflection to a distal tip of the first catheter.

98. The method of claim 93, wherein the inserting the first catheter control handle into the first handle controller includes clamping the first catheter control handle to the first handle controller.

105. A system for remotely controlling the positioning of a medical device within the body of a patient, the system comprising:

a robotic device configured to position the medical device within a body of a patient;

the robotic device comprising;

a handle controller effective to manipulate any control on the medical device;

a driver effective to move the medical device forward and backward; and

a cá

theter feeder effective to deliver the medical device inside the body; and

a remote control mechanism effective to control the robotic device.

106. The system of claim 105, wherein the handle controller is modular, each module being adaptable to a particular type of medical device.

107. The system of claim 105, wherein the handle controller is adaptable to a variety of medical devices.

108. A system for remotely controlling the positioning within the body of a patient of an elongated medical device having a proximal end, the system comprising:

a robotic device configured to position the medical device within the body of the patient; and

a remote control mechanism configured to control the robotic device, wherein the robotic device comprises a handle controller to receive the proximal end of the medical device.

109. A system for remotely controlling the positioning of a medical device within the body of a patient, the system comprising:

a robotic device configured to position the medical device within a body of a patient;

the robotic device comprising;

at least two controllers;

a distal controller to control a larger medical device, and a proximal controller to control a smaller medical device which is sent through the larger one, wherein the controllers are effective to manipulate any controls on the medical devices and or the medical devices themselves;

at least two drivers effective to move the proximal medical device forward or backwards within a distal medical device, with the ability to advance the distal medical device forward independent of the proximal medical device;

a catheter feeder effective to deliver the medical devices inside the body; and

a remote control mechanism effective to control the robotic device